KANKEE BRIEFS
Resolved: The member nations of the World Trade
Organization ought to reduce intellectual property
protections for medicines.
2021 September October
KANKEE BRIEFS
Letter From The Editor
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Supporters
Scott Brown
Devyn (Toby) Blaylock
Danielle Jones
Crystal Huddleston
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Topic Analysis
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1.1 Introduction
1.1.1 Introduction
Another day, another intellectual product that extensively uses other people’s intellectual
property that is sent via late night emails, Reddit forums, and Discord channels. Same old same old. I am
not a lawyer, but what I find hilarious is that it may be possible I have a de facto copyright/trademark on
“Kankee Briefs” and the briefs I produced through my continued usage of the title even though the
name is derived from sci-fi, I have never filed a copyright/trademark on “Kankee Briefs,” and most of
what goes into briefs is the works of other people. If anyone who knows about IPR and debate wants to
explain how briefs are even legal, I might be worthwhile in me knowing this information.
Personal meta IP rants aside, I thought we would be done with Covid-19 centric topics soon
after the public health emergency topic, but than we had to learn our Greek alphabet for a pandemic.
Who would have thought? IP law. It’s about as boring as you might expect. It gets yucky sometimes with
medical discourse and needles and gross stuff like that (I’m easily squeamish okay). Beyond the folks
that love legal topics (I just happen to know way too much about what I hate), doesn’t seem like the
most fun topic. Regardless, you didn’t come here to read about how I think doctors are scary or don’t
like whatever the current topic is (it’s almost as if I never don’t have complaints about almost every
topic selection). We have some master debating to do.
1.1.2 What words can words mean in the topic?
Resolved: The member nations of the World Trade Organization ought to reduce intellectual property
protections for medicines.
When looking at the text of the resolution, there are very few terms that are unclear as most are
stringently defined terms of art or things that already exist. The World Trade Organization (WTO) is an
UN agency (unrelated to two other finance centric UN agencies known as the World Bank and the
International Monetary Fund) that regulates trade (hence the name).
Similarly, intellectual property is also very well defined in different literature bases. Below is a basic,
non-exhaustive definition of intellectual property; if you’re confused on what IP is and what it covers,
there is a further explanation I’d suggest reading at the WIPO website that you can find at that link.
IP includes patents, copyrights, trademarks, etc.
WIPO No Date [World Intellectual Property Organization, UN agency that specifically deals with IP
law, No date, "What is Intellectual Property (IP)?," WIPO, https://www.wipo.int/about-ip/en/]/Kankee
What is Intellectual Property? Intellectual property (IP) refers
to creations of the mind, such as inventions; literary and
artistic works; designs; and symbols, names and images used in commerce. IP is protected in law by, for
example, patents, copyright and trademarks, which enable people to earn recognition or financial benefit from what they invent or
create. By striking the right balance between the interests of innovators and the wider public interest, the IP system aims to foster an
environment in which creativity and innovation can flourish.
Most pre-topic research by myself and other appears heavily focused on a specific form of intellectual
property: patents. Patents usually include things like specific inventions, whether it be an iPhone or
ibuprofen.
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There aren’t legal definitions of what a medicine is (though I can, as I often am, be wrong).
Medicines can treat or prevent a disease
Oxford Languages No Date [Oxford Languages, this is where Google Dictionary get’s its dictionary
definitions from and I find it funny it sounds much more authoritative when you mention Oxford
definitions and not Google definitions even though they’re the same thing, No date, “Medicine” Oxford
Languages,
https://www.google.com/search?q=define+medicine&oq=define+medicine&aqs=chrome..69i57j0i512l9
.2368j0j4&sourceid=chrome&ie=UTF-8]/Kankee
med·i·cine/ˈmedəsən/the science or practice of the diagnosis, treatment, and prevention of disease (in technical use often taken to exclude
surgery). "he made distinguished contributions to pathology and medicine" Similar: medical science practice of medicine healing therapeutics
therapy treatment healing art 2. a
compound or preparation used for the treatment or prevention of disease,
especially a drug or drugs taken by mouth. "give her some medicine" Similar: medication medicament remedy cure nostrum
patent medicine
There are many medicines that exist that have intellectual protections on them as well as member
nations, but it seems most literature is confined to the US/EU and the impact of their actions globally.
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1.2 Affirmative Topic Analysis
1.2.1 Insulin
Contention 1 is Insulin. Currently, pharmaceutical companies jack up the price of insulin as only
a select few are suppliers and patients have no choice but to buy or die. With patents, it is near
impossible for generics to enter the market, which allows the monopolies to name their price for
marginally better insulin. That’s bad as many diabetics need insulin to live.
Important distinction: for anyone who is thinking of crude “ban McDonald’s” counterplan to
make people less overweight, most people who usually require insulin are born with diabetes, and those
who usually don’t require insulin usually acquire diabetes from bad health choices. Not eating at
McDonald’s can’t reverse diabetes for those born with it and conflating the two types of diabetes
usually leads to worse diabetes activism for those who can’t do anything about it.
1.2.2 Innovation
Contention 2 is Innovation. Several important things to note: this entire contention is a massive,
preemptive link turn to the innovation DA given its status as the core neg generic. It states that even if
medical innovation seems high now, this is due to the prevalence of patent-thicketing and evergreening,
which are all ways to increase the longevity and the monopoly of the original patent for a drug (these
are complex patent law concepts that are much better explained in the evidence down below). Current
innovation isn’t actually that innovative, rather, anti-competitive patent rigging to ensure a
pharmaceutical company maintains its monopoly beyond what’s usually inscribed by law (~20 years),
which helps profits more than patients’ health.
Evaluated in a vacuum, this contention doesn’t seem particularly strong, especially given how
impacts listed like drug prices can be easily solved by most medical reform counterplans like
pharmaceutical price controls or Medicare-for-All. However, given how this is one of the few DA’s
available on this topic, this contention sets the 1AR up in a spectacular position as almost all the work
for the link turn was done already in the 1AC.
There can be further research into the positive impacts of innovation, but there isn’t very many
cards that say “to make X blockbuster bioweapon/super-bug killer drug, kill off all patents,” and much
evidence in the industry holds the view patents are important for innovation. However, most neg
innovation DA’s in other briefs will likely have impacts that can be read, and the 1NR may very well read
the impact for you (so you can straight turn it)
1.2.3 Vaccine Apartheid
Contention 3 is Vaccine Apartheid. Originally intended to be focused on vaccine diplomacy, US
military supremacy, and soft power, the contention dramatically changed from “US supremacy/my
personal love letter to hegemony enthusiasts” to a more “soft left developing country sovereignty”
approach. The developing world will take years if not decades to be fully vaccinated – for a particularly
striking example, note that the state of Florida has more vaccines then the entire continent of Africa.
This is due to how the developed world is stockpiling most of the world’s vaccines and not allowing the
developing world to manufacture their own vaccines because of WTO intellectual property rules. Most
literature argues for a TRIPS Covid-19 vaccination/treatment waiver to allow developing countries to do
whatever they want with Covid-19 related intellectual property.
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This contention may suffer from “gift CP’s,” where developed countries manufacture and gift
vaccines to developing countries; however, given the more anti-colonial angle, this isn’t as much of a
problem. There are several cards specifically to answer “gift CP’s,” with a focus on anti-capitalism and
independence from former colonial powers like the US that only domestic development by developing
countries can solve.
Evidence in this contention also uses language of “global North” and “global South” to represent
the developed and developing world. As a word of forewarning, these terms may be susceptible to
Word PIKS given that they may or may not be problematic. I have not looked enough into the subject to
see if it’s worthwhile for students to edit cards for language for these terms, but I’d suggest researching
it yourself on the off chance it may arise as an issue. There likely will be an answer to the Word PIK in
the AT File a few weeks from now regardless.
As another side note, most evidence in this contention is not in the context of the Delta variant,
but I am certain that only makes these arguments that much stronger.
One more important side note: vaccinations may possibly not be a topical medicine given how
they are a preventive, not reactive treatment for patients. I’d suggest finding topicality interpretations
and we-meet arguments that include vaccinations, though vaccinations are one of the most reasonable
affs there can be on the topic.
1.2.4 IPR Fake News
.
Contention 4 is IPR Fake News. Here is where I rant about philosophy for three cards.
Intellectual property is not a real, tangible thing – its akin to the rules of chess or reasons why Star Strek
is better then Star Wars. Its an abstract, immaterial concept that people have rights to own concepts
and their usages, which of course has some philosophical issues to bear, most of whom related to how
arbitrary IPR is and how it claims ideas collectively created by cultures for the individual. If we take the
example of the origins of Star Wars I-VI, many concepts, cultures, and creations influenced George
Lucas, to the point of which there is an entire Wikipedia page dedicated to it, but (until 2012 when
Disney bought out Lucasfilm) he doesn’t share Star Wars IPR with any other entities that inspired it.
Despite the fact that the Star Wars franchise is not 100% derived from George Lucas’ thoughts
and ideas, he maintains his status as the originator of Star Wars and profited off virtually all toy sales
with his intellectual property. This analogy isn’t perfect, especially as you can’t buy a patented Star Wars
as you may for certain insulin drug, but this contention is more so about IPR generally being bad, with
medicine being just one example of it.
I am not a philosophy buff, and these arguments are likely better articulated by others, and you
may find better evidence elsewhere, so please use this contention (as you should with all briefs) as a
stating point for original research that may or may not have IPR protections.
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1.3 Negative Topic Analysis
1.3.1 Innovation
Contention 1 is Innovation. Naturally, this has been the go-to topic DA, to the point of which
other briefs did not cut other arguments besides the Innovation DA. I don’t think its particularly good,
but neither is offensive neg ground on this topic to begin with. Most affs can be solved with any
healthcare reform counterplan like single-payer, but given how toxic healthcare reform is within
Congress after Obamacare, politics cannot reasonably be a net benefit. Naturally, the Innovation DA
became one of the only net benefits as having the government pay whatever ludicrous prices Big
Pharma is peddling can only increase innovation given there is an even broader market.
Given how to this is the go-to topic DA, and I really hate cutting generic innovation DA’s, please
refer to other briefs after looking through the few cards I presented here as they have dedicated many
more resources towards this then I have.
All the reasons why I think an aff innovation contention is good are reasons why a neg
innovation contention is bad.
1.3.2 Single Payer CP
Contention 2 is the Single Payer CP. This is one of the generic topic counterplans that works well
with the Innovation DA. Though single payer is the counterplan cut here, I’d suggest running any
counterplan that helps make medicines more affordable but does not reduce their price/patent. As long
as the pharmaceutical companies are selling to someone, I’m willing to bet they don’t care especially
much who is paying if they have money. Conveniently, the government has lots of money (or at least the
ability to print seemingly endless amounts of it). A cap/lower drug prices CP is not the counterplan you
should run with an Innovation DA given how it explicitly reduces company profits and the expectations
of future gains, which are the most common warrants for Innovation DA links.
I’d suggest finding a solvency card for affs about drug prices to avoid the issues listed above,
though having the government pay for everything does sound fairly reasonable.
1.3.3 WTO Backlash
Contention 2 is WTO Backlash. This is a made-up politics DA. I will fully admit there is no
worthwhile evidence after Biden became president of anyone proposing that the US should leave the
WTO. Most evidence regarding this argument references either Trump pressuring a WTO staffer for
better trade policies (by reclassifying the US as a developing country) by threatening to withdraw, or ~3
GOP Congresspeople rallying up a bill that never would pass to leave the WTO. Given the worldwide
pandemic, alongside former president Trump’s attempts at hijacking the election or convincing people
to drink bleach, there was not much thorough thought or political backing for this.
However, while the uniqueness evidence is laughable, this would likely be a logical consequence
of WTO action forcing the US to limit its IPR on medicine given the immense lobbying from the
pharmaceutical industry. The politics links for this topic are the best I have ever seen on a LincolnDouglas topic – the pharmaceutical industry is the largest lobbyer of Congress, more then oil, gas,
defense, or firearms and they desperately want to keep their patents. Excuse my excessive emphasis,
but I cannot stress how amazing these links are and can be.
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As a word of warning, the internal link uniqueness of US non-support of WTO or global trade is
especially bad given Trump and the global pandemic.
All politics links in this contention can be copied and pasted directly into the infrastructure DA.
1.3.4 Infrastructure
Contention 4 is Infrastructure. It is a bill that is supposed to increase infrastructure spending in a
variety of areas – I, as well as others, have often referred to this DA when we have run out of ideas for a
specific topic. This is mostly the case this time as well, but, the reconciliation process happens
exclusively within these next two months, if not sooner if moderate Democrats have their way. Similar
to previous major spending bills like CARES or AHA, there will be lot’s of hoopla on why certain people
won’t want to support it, but they will in the end as they don’t want to be “that guy.”
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Affirmative
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Contention 1: Insulin
Insulin price gouging makes an essential medicine unaffordable – that causes diabetics
to skip/ration doses, skimp on necessities, or die trying.
Barker 20 [Erin M Barker, Executive Editor at the Campbell Law Review with a JD, 2020, "When Market
Forces Fail: The Case for Federal Regulation of Insulin Prices," Campbell Law Review,
https://heinonline.org/HOL/P?h=hein.journals/camplr42&i=331]/Kankee
INTRODUCTION Today, a
single vial of insulin can cost more than $250 in the United States, and most patients
use between two and four vials each month.' Consequently, if a diabetic patient is without insurance, or if insurance does not
cover a specific brand of insulin, that person could pay upwards of $500 to $1,000 per month out-of-pocket for an
essential medication.2 These costs are astronomical and unacceptable-the federal government must step in to
regulate pricing. On January 11, 1922, fourteen-year-old Leonard Thompson faced the end stages of a terminal illness: diabetes mellitus,
otherwise known as type 1 diabetes.3 Thompson weighed only sixty-five pounds after living with diabetes for three years.' His attempt to
control his diabetes with a starvation diet failed to keep him from slipping in and out of a diabetic coma.5 Desperate for any chance to save his
son, Thompson's father agreed to let the hospital inject the boy with a recently-discovered drug-insulin.6 Thompson would be the first human
subject to receive the injection,' and the results were nothing short of miraculous.' His blood sugar lowered to a normal level, and the glucose
and ketones' present in his urine also lowered to a tolerable level.10 Four men discovered this "wonder drug"": Frederick Banting, Charles Best,
James Collip, and John Macleod.12 Following Banting's and Best's initial publication of their results,13 the discovery of insulin and its successful
application to human subjects landed on the covers of newspapers worldwide.14 Insulin provided life-saving treatment for people who
previously faced a death sentence; the drug brought diabetic patients out of comas, allowing them to end their starvation diets and eat
carbohydrates." For their discovery, Banting and Macleod won the 1923 Nobel Prize in Physiology or Medicine and split their winnings with Best
and Collip.16 Banting, Best, and Collip acquired an American patent on insulin and its method of creation on January 23, 1923.17 When
applying for their patent, the trio maintained that "their goal was not profit, but ensuring the speedy and safe availability of their discovery to
the public.""8 They then sold their patent rights to the Board of Governors of the University of Toronto for $1.00 each.1 9 In a letter to the
University's president, the trio wrote, "The patent would not be used for any other purpose than to prevent the taking out of a patent by other
persons. When the details of the method of preparation are published anyone would be free to prepare the extract, but no one could secure a
profitable monopoly."20 Banting, Best, and Collip stated a clear goal: their lifesaving invention was to remain available to all. That goal has
failed. This Comment analyzes how federal regulation of insulin prices will correct failed market forces, leading to a stabilized market for the
indispensable medication. Part I of this Comment will provide a brief overview of the current state of the insulin market in the United States.
Part II of this Comment will explain economics-based justifications for adopting federal legislation to regulate the insulin market. It will also
provide an overview of the types of regulatory schemes that the government could utilize in this market. Part III of this Comment will describe
and critique legislation that two states-Nevada and Colorado-have already acted to regulate the cost of insulin and will then examine currently
proposed federal legislation that aims to lower insulin prices. Lastly, Part IV of this Comment offers a solution: the addition of language to the
proposed federal legislation, incentivizing competition and positively affecting market prices through the nationalization of patents. I. THE
STATE OF THE INSULIN MARKET IN THE UNITED STATES TODAY A. Economic Impact ofRising Insulin Prices From
2002 to 2013, the
cost of insulin nearly tripled.21 Then, from 2012 to 2016, the cost of insulin rose dramatically again, nearly
doubling. 22 In the first month of 2019 alone, insulin manufacturers Sanofi and Novo Nordisk raised some of their
insulin product prices as much as 4.9% and 5.2%, respectively. 23 As of 2017, diabetes treatment and complications
cost the United States ("U.S.") more than $327 billion per year, making it the most expensive chronic illness in
the country.24 This cost is a combination of $237 billion in direct medical costs, including $15 billion for insulin,
and $90 billion in indirect costs. 25 The American Diabetes Association reports: While much of the cost of diabetes appears to fall on insurers
(especially Medicare) and employers (in the form of reduced
productivity at work, missed work days, and higher
employer expenditures for health care), in reality such costs are passed along to all of society in the form of higher
insurance premiums and taxes, reduced earnings, and reduced standard of living.26 Government insurance,
including Medicare, Medicaid, and insurance through the military, provide for a majority (67.3%) of the cost of diabetes care in this country.27
Private insurance pays for 30.7%, and the uninsured pay for 2% of the cost of diabetes care. 28 Uninsured
diabetics visit the
doctor 60% less and receive 52% fewer prescriptions than insured diabetics, yet uninsured diabetics
account for 168% more emergency department visits than insured diabetics.2 9 Accordingly, because of both the
direct and indirect costs of diabetes care, it is not just diabetics who are paying-all of society shoulders the financial burden of the increasing
cost of diabetes. 30 B. Social Impact ofRising Insulin Prices Rising
insulin prices induce "negative health and financial
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burdens on the population." 3 1 Of the 30 million diabetic Americans, approximately 7.4 million require
daily doses of insulin to survive.32 Rising insulin prices have forced some to cut back on or skip doses of
insulin. 3 Others elect to forgo other necessities such as food or rent in order to afford insulin. 3 A 2018 study found
that almost 26% of diabetics in the U.S. had rationed their insulin the previous year.35 Recently, poignant stories
have emerged detailing the tragic societal consequences of these negative health and financial burdens, including deaths due to an inability to
afford insulin. 6 One such story is that of Alec Smith, a twenty-six-year-old who died less than a month after his mother's health insurance plan
removed him as a beneficiary.3 7 Smith, who worked a full-time job and earned more than minimum wage, could afford neither new insurance
nor the monthly $1,000 out-of-pocket cost of his insulin. 38 Another story is that of Meaghan Carter, a forty-seven-year-old woman who died
alone on her sofa on Christmas night because she could not afford insulin.3 9 Carter, a nurse, was between jobs.4 0 She planned to start a new
nursing position with health insurance benefits only a week after her death.4 1 Carter's family found empty vials of insulin among Carter's
nursing supplies in her home.42 According to Carter's sister-in-law Mindi Patterson, "[s]he had gauze, bandages and all her nursing supplies""plenty to take care of others but not enough to take care of herself." 4 3 The stories of Alec Smith and Meaghan Carter demonstrate that there
is more than just money at stake here-people's lives
are on the line because of insulin prices in the U.S. Almost a
hundred years after the discovery of insulin, diabetics should not be forced to ration an essential drug or
face death due to excessive costs. Banting, Best, and Collip's goal was to make insulin affordable for all," but that is not the case
today. The current price of insulin in the U.S. is unacceptable and must be addressed. II. THE FEDERAL GOVERNMENT SHOULD
REGULATE THE INSULIN MARKET BECAUSE OF THE FAILURE OF TYPICAL MARKET FORCES
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Excessive insulin costs are due to patent exclusivity causing monopolies with
customers that have no choice but to buy
Barker 20 [Erin M Barker, Executive Editor at the Campbell Law Review with a JD, 2020, "When Market
Forces Fail: The Case for Federal Regulation of Insulin Prices," Campbell Law Review,
https://heinonline.org/HOL/P?h=hein.journals/camplr42&i=331]/Kankee
A. Economics-Based Justifications Effective
federal regulation will alleviate at least two causes of high insulin prices: patents
preventing competition from manufacturers of "generic" insulins, and the failure of normal market forces due
to the lack of competition.4 5 U.S. patent law provides patent-holders with twenty years of patent
exclusivity for the development of new drugs.46 Exclusivity permits patent-holders to set prices and control the market for at
least twenty years.4 7 Currently, there are three primary pharmaceutical companies manufacturing insulin in the U.S. market: Eli Lilly, Novo
Nordisk, and Sanofi. 4 8 These three pharmaceutical
companies "minimize competition by patenting incremental
changes" to their insulin formulas, making it extremely difficult for other manufacturers to develop
affordable, effective generics known as biosimilars. 49 For example, even though Sanofi's primary patents for the insulin
Lantus expired in 2015, Sanofi has filed around seventy patents for incremental changes since 2000.s0 These
secondary patents will allow Sanofi to receive patent protection over the formula for Lantus through at least March
2028. Thus, the three pharmaceutical companies that manufacture insulin have developed what is essentially a monopoly
over the insulin market through this patent-based barrier to potential competitors. 52 Because it is so
difficult for other manufacturers to create biosimilar insulins due to patents, there is currently very little
room for competition from other drug manufacturers." In fact, Eli Lily and Sanofi produce the only two biosimilar insulins currently on
the market, meaning these manufacturers can maintain the monopoly.54 In a typical market, product price usually falls as
time goes on. Common causes of a decrease in market value include competitors entering the market
and introducing similar, cheaper alternatives, or a current manufacturer making an advancement that
lowers the value of older versions of a product.5 6 Consumers can choose to either purchase a cheaper
alternative or upgrade to the newer, more advanced product-either choice would lower demand for the original
product, thus lowering the market value of the older version.5 7 Insulin is not a typical consumer product." Not only do
patents prevent competitors from entering the market, but type 1 diabetics cannot exert pressure on the
pharmaceutical companies to lower prices by simply choosing to not purchase insulin.59 Instead, "[tlype 1
diabetics without adequate insurance coverage are vulnerable to price increases because they can't live without
the drug . . . . 'People have to buy insulin no matter what the cost is . .. [giving] a lot of strength to the people
selling insulin."' 0 When the marketplace is unable to self-regulate a monopoly through competition, the
traditional solution is the passage of regulation rather than leaving the monopoly free within "the unregulated marketplace or to the
antitrust laws for correction."61 When determining the most appropriate type of regulation, there are several options available, the most
viable of which are discussed below. 6 2 B. Regulations Available to Increase Competition
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Patents allow a “government sanctioned monopoly” on insulin – looser IP laws would
substantially decrease the cost of insulin – research and manufacturing costs are very
low now
Johnson 18 [Judith A. Johnson, Specialist in Biomedical Science Policy at Congressional Research
Service with an MS in molecular biology from Yale, 11-19-2018, “Insulin Products and the Cost of
Diabetes Treatment,” Congressional Research Service,
https://fas.org/sgp/crs/misc/IF11026.pdf]/Kankee
Insulin is a hormone that regulates the storage and use of sugar (glucose) by cells in the body. When
the pancreas does not make
enough insulin (type 1 diabetes) or it cannot be used effectively (type 2 diabetes), sugar builds up in the
blood. This may lead to serious complications, such as heart disease, stroke, blindness, kidney failure,
amputation of toes, feet, or limbs. Prior to the discovery of insulin treatment, type 1 diabetics usually died from
this disease. There were 23.1 million diagnosed cases of diabetes in the United States in 2015 according to
the Centers for Disease Control and Prevention (CDC). Adding an estimated 7.2 million undiagnosed cases brings the
total to 30.3 million (9.4% of U.S. population). People with type 1 diabetes, about 5% of U.S. cases, must have insulin
injections to survive. For those with type 2 diabetes, about 95% of cases, many can control their blood glucose by following a healthy diet,
losing weight, maintaining regular physical activity, and taking oral medications, but some require insulin injections to control their
blood glucose levels. Data collected in the 2010-2012 National Health Interview Survey from diabetics aged 18 or older indicate that
14% are treated with insulin alone, 14.7% are treated with both insulin and oral medication, 56.9% are treated with oral medication alone (not
insulin), and 14.4% are not treated with either medication. The
price of various insulin products has risen significantly.
From 2001 to 2015, the price of one type of insulin (insulin lispro) increased 585% (from $35 to $234 per vial). One vial
might last a patient less than two weeks. Given the number of Americans dependent on insulin, Congress may be interested in
considering whether consumers have access at a reasonable cost. Insulin Discovery and Development Insulin was discovered nearly a century
ago, in 1921, by researchers at the University of Toronto; their U.S. patent was later sold to the university for $1. Manufacturing challenges
resulted in collaboration with Eli Lilly in 1923 in order to make enough insulin for the North American market. They also licensed the right to
produce insulin to other firms including a Danish company which eventually became Novo Nordisk. Insulin is a small protein composed of 51
amino acids. Because it is made from a living organism, it is considered to be a biologic, or biological product. Like many other biologics (such as
drugs or vaccines), insulin was obtained in the past by extraction from animals. Production has changed over the years as researchers have
made alterations to insulin, easing its use by the patient. The ideal treatment regimen for diabetics would closely mimic the way insulin
secretion occurs in the body. This would involve a consistent insulin level between meals combined with a mealtime level of insulin that has a
rapid onset and duration of action to match the glucose peak that occurs after a meal. The original insulin, also called regular insulin, is a shortacting type of product with a duration of action of about 8 hours, making it less suitable for providing 24-hour coverage. In the late 1930s
through the 1950s, regular insulin was altered by adding substances (protamine and zinc) to gain longer action; these are called intermediateacting insulins. One such advance (neutral protamine Hagedorn, or NPH) was patented in 1946 and is still in use today. It allowed for the
combination of two types of insulin in premixed vials (intermediate-acting and regular insulin), making a single daily injection possible for some
patients. In 1982, recombinant DNA technology allowed for the replacement of animal insulin extracted from cattle and pig pancreases by
human insulin (Humulin R) made in a laboratory fermentation process using microorganisms. These advances still did not mirror the normal
release of insulin. Over the past few decades, slight modifications of the insulin molecule—called insulin analogs—have been developed. This
has resulted in five types of insulin products on the market: long-acting, rapid-acting, intermediate-acting, short-acting (regular insulin), and
premixed. In the early 2000s, the long-acting insulin analogs, Lantus (insulin glargine) and Levemir (insulin detemir), entered the market. In
addition, the rapid-acting insulin analogs Humalog (insulin lispro) and Novalog (insulin aspart) were developed to allow for quicker absorption
and shorter duration of action at mealtime. The insulin analogs more closely replicate normal insulin patterns in the body and resulted in a
greater number of patients using these new products. In 2000, of privately insured adults with type 2 diabetes using insulin, 19% were using
analog insulins; by 2010, 96% were using these products. Studies
indicate that the more expensive analogs do not seem
to provide any advantage over regular insulin in controlling glucose levels or preventing diabetes-related complications, but
they are more convenient for the patient. Insulin Regulation and Production In the past, all biologics, including insulin, were regulated by the
National Institutes of Health (or its precursors) under the Public Health Service Act (PHSA). In 1941, Congress gave the Food and Drug
Administration (FDA) authority over the marketing of insulin. As a result, insulin has been regulated as a drug under the Federal Food, Drug, and
Cosmetic Act (FFDCA) rather than as a biologic under the PHSA. In the United States “generic” insulin products are referred to by FDA as
“follow-on” products and are not called biosimilars (which are regulated under the PHSA). However, under a provision of the Biologics Price
Competition and Innovation Act (BPCIA) of 2009, biologics approved as drugs under the FFDCA will transition to biological licenses under the
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PHSA in March 2020. BPCIA was enacted as Title VII of the Patient Protection and Affordable Care Act (ACA, P.L. 111-148). Currently, three
firms—Eli Lilly, Novo Nordisk, Sanofi Aventis—account for over 90% of the global insulin market and produce the
entire insulin supply for diabetic patients in the United States. For the most part, insulins produced by these companies are
brand-name drugs. In general, brandname drugs cost more because the drug manufacturer has free rein in setting
the drug price due to a government sanctioned monopoly for a defined period of time. Branddrugs are protected from
market competition by (1) patents issued by the U.S. Patent Office and (2) a regulatory exclusivity period granted by FDA under the Drug Price
Competition and Patent Term Restoration Act of 1984 (P.L. 98-417), also called the Hatch-Waxman Act. According to some analysts, lack
of
price competition in the U.S. insulin market is a contributor to the high cost of this vital drug. The price of a drug is
directly affected by the number of different manufacturers marketing the drug. According to an FDA analysis of generic chemical drugs, “the
first generic competitor prices its product only slightly lower than the brand-name manufacturer. However, the
appearance of a
second generic manufacturer reduces the average generic price to nearly half the brand name price. As
additional generic manufacturers market the product, the prices continue to fall, but more slowly. For
products that attract a large number of generic manufacturers, the average generic price falls to 20% of
the branded price and lower.” One “generic” insulin product—or what FDA calls a “follow-on” product—is being marketed in the
United States. Eli Lilly received tentative approval for Basaglar from FDA in August 2014. Final approval occurred in December 2015 following
resolution of patent issues with Sanofi-Aventis, maker of the brand product, Lantus (insulin glargine). The Basaglar application was submitted to
FDA under Section 505(b)(2) of the FFDCA and relied on the FDA’s finding of safety and effectiveness for Lantus. Eli Lilly began marketing
Basaglar in the United States in December 2016; by the end of December 2017, Basaglar had captured about 17% of the U.S. Lantus volume
share. Because three firms manufacture all the insulin used in this country, the market behaves differently from the usual case in
pharmaceutical markets where generic competition results in price reductions following patent expiration and the end of the exclusivity period
granted by FDA under Hatch-Waxman. Basaglar, the only follow-on insulin available in the United States, is made by one of the three insulinmaking firms, Eli Lilly. Basaglar’s approval has not resulted in a new insulin manufacturer on the U.S. market. Industry observers believe that as
other pharmaceutical companies enter the insulin market, price reductions may begin to occur. In July 2017, FDA granted tentative approval to
a second insulin glargine product, Lusduna Nexvue, made by Merck. However, in October 2018 Merck announced that it is discontinuing
Lusduna. Some industry analysts believe Merck’s decision was due to the drug rebates offered by the three manufacturers of insulin products.
For drugs such as insulin with a high list price, manufacturers may use a high rebate to gain placement on an insurance company formulary. This
results in making the drug more affordable for insurance plans, but the
drug remains expensive for the uninsured, as well
as for those with high cost-sharing insurance plans. Price of Insulin, Cost of Manufacture, and Profit The price of a
drug often has very little basis in the cost of manufacturing a drug. Also, it is very rare to find data on manufacturing
costs; this is considered to be proprietary information. However, a 1995 paper in Biotechnology and Bioengineering focused on the process
used by Eli Lilly in the commercial production of insulin using E. coli bacteria. The authors found that the
total cost involved in
making enough insulin to treat one patient per year is $33.60. This amount would be altered by inflation, but would be
offset by process improvements. Most of the manufacturing cost (94.2%) is associated with the recovery and purification of insulin; the
remainder (5.8%) is the fermentation process using E. coli. The economic analysis includes the cost of raw materials, product separation
materials, facility overhead (depreciation and maintenance of the facility), treatment and disposal of waste materials, and labor of plant
operators and laboratory scientists who perform analysis of the process and product (quality control/quality assurance). It does not account for
other costs, such as the cost of vialing and quality assurance of vialing, distribution costs, promotion and advertising costs, and briefly mentions
research and development cost recapture. In the case of insulin, however, much of the initial basic research—original drug
discovery and patient trials—was performed 100 years ago. Other more recent costs, such as developing the recombinant
DNA fermentation process (over 35 years ago) and the creation of insulin analogs (about 20 years ago) may account for some portion of the
current price of insulin products, but exactly how much is known only by the manufacturers. The pricing of insulin could also reflect accounting
for research costs of other drug products, both the past costs of drugs that were not successful as well as future products that are currently
under development. A September 2018 study published in BMJ Global Health calculates that a
year’s supply of human insulin
could be $48 to $71 per person and between $78 and $133 for analog insulins; this amount would cover production
costs and still deliver a profit to the manufacturer. How much profit is fair is another piece of the drug pricing puzzle. A
November 2017 Government Accountability Office (GAO) report found that the average profit margin was 20% in 2015 for the largest 25 drug
companies, compared with 6.7% for the largest 500 companies in general. The three insulin manufacturers are among the largest 25 drug
companies.
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Reducing IP protection for insulin increases innovation – it stops redundant research
and competition
Emily 20 [Emily Hanson, JD Candidate at the University of Georgia School of Law, 2020, “Economic
Burdens of Life: Trade Secrecy and the Insulin Pricing Crisis in the United States,” Journal of Intellectual
Property Law,
https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?article=1457&context=jipl]/Kankee
The discussion above paints a grim picture. The abbreviated pathway to approval provided for under federal law has not achieved its goal of
increasing competition and lowering prices in the insulin market. As progress stalls, many
people with diabetes continue to
struggle to pay for the medication they need as insulin prices continue to rise. It should be noted that some
steps have been taken in 2019 by both corporations and governments to alleviate the insulin pricing crisis. For example,
the three major insulin manufacturers, Eli Lilly, Sanofi, and Novo Nordisk, have each announced that they will lower the list prices of their
insulin products.180 Furthermore, pharmacy benefits manager, Express Scripts, announced a price cap of twenty-five dollars per month for its
members.181 Colorado recently passed legislation capping the price of insulin at $100 per month for insured patients.182 These efforts
have one thing in common: they illustrate the fact that attention is increasingly being directed at this issue. The increase in attention, however,
does not mean that the issue is solved. Unfortunately, all of the measures identified above are too limited in scope to
serve as a complete solution to the problem. After all, Novo Nordisk or Express Scripts, for example, may decide
tomorrow that the price guarantees they make today are no longer economically viable, which will leave
diabetic patients in much the same place they are now. Many diabetics with health insurance in Colorado are seemingly out of immediate
danger, but Colorado is home to only a very small percentage of all diabetics in the U.S.183 This is why legislation at the federal level is
necessary to correct this issue for good. As discussed in section III(C) infra, trade secret is one of the three forms of intellectual property
protection available to pharmaceutical innovators. In order for an innovation to qualify for this protection, it must: (1) confer economic benefit
upon the holder, (2) not be generally known, and (3) be the object of reasonable steps by the holder to maintain its secrecy.184 Makers of
pharmaceutical products, and biologic drugs in particular, avail themselves of trade secret protection quite liberally.185 Trade
secret is
particularly attractive
for protecting the manufacturing processes for insulin and other biologics, which has a major
differ considerably from chemical medications in terms of the
difficulty of manufacturing them.187 Small-molecule chemical medications are relatively simple to describe scientifically,188 and a
impact on competition.186 Biologics like insulin
generic manufacturer can use any of a number of methods to synthesize the compound, all of which produce a result easily proven to be
identical to the reference product.189 Insulin and other biologics, by contrast, have
much more complex chemical
structures.190 Small differences in the method of synthesis can lead to broad variation in the final result.191 This
means that showing biosimilarity is very difficult unless the manufacturer uses the same method that the
maker of the reference product used.192 Furthermore, the precise molecular identity of some biologic drugs is not
known because the analytical techniques needed to make that determination do not yet exist.193 Crucially, to qualify for abbreviated
approval under the Biosimilars Act, the maker of the biosimilar must make a product that not only is biosimilar, but can be shown to be
biosimilar.194 Because trade
secret protection can theoretically last indefinitely,195 makers of would-be
biosimilar insulins may never have access to manufacturing process information, all but foreclosing the
possibility of producing a follow-on insulin that the maker is able to prove is biosimilar to the reference.196 A claim that X
is the same as Y is impossible to prove or disprove when Y’s identity is not known. A scaling back of trade
secret protection for pharmaceuticals would ameliorate this problem. The Biosimilars Act does not require the maker
of a reference product to disclose manufacturing information to any greater extent than is required under Hatch-Waxman, which means that it
is unlikely to be successful in increasing competition in the insulin market now that insulin is within its scope.197 Insulin will likely continue to
be more trouble than it is worth to biosimilar manufacturers. The Defend Trade Secrets Act of 2016 provides an extremely broad scope of the
type of information that may be eligible for trade secret protection: [A]ll forms and types of financial, business, scientific, technical, economic,
or engineering information, including patterns, plans, compilations, program devices, formulas, designs, prototypes, methods, techniques,
processes, procedures, programs, or codes, whether tangible or intangible, and whether or how stored, compiled, or memorialized physically,
electronically, graphically, photographically, or in writing.198 The breadth of the protection available under the DTSA means that makers of
follow-on insulins will have an extremely difficult time showing that their products are biosimilar. Statutorily eliminating biologics
manufacturing process information from trade secret eligibility (as an amendment to the Biosimilars Act, for example) would force
pharmaceutical companies to choose among three alternatives. They could: (a) include process information in their patent application, (b)
apply for separate patent protection for the process and the product, or (c) leave the process information with no protection at all.
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Acknowledging choice (c) to be in all likelihood the least popular of these, the net effect would be that the process by which biologics like
insulin are manufactured would become part of the public omain once the patent expires, rather than remaining secret indefinitely as it does
today. This change would naturally have downstream effects, both positive and negative. The first advantage would be that insulin and other
biologics would
become more attractive to makers of follow-on products. Armed with the knowledge needed to
create a biosimilar without going through the costly process of additional research and development, followon firms could produce biosimilar insulins more cheaply. The second advantage would be that the growing fund of
public knowledge about insulin and other biologics would facilitate greater innovation in the field over time.199
By keeping critical information about their discoveries secret, pharmaceutical companies prevent other
companies, universities, and private research firms from benefitting from it.200 Trade secret law is often
criticized for its tendency to cause redundancy and duplication of effort,201 and repetition of clinical
trials to prove that a follow-on is biosimilar or interchangeable can cost hundreds of millions of dollars.202 A
free flow of information about process in a field where process has a tremendous influence on the identity and quality of the final
product203 would have substantial value to society.204 To that end, the third advantage to reducing trade secret protections would
be a rebalancing of the public and private interests at stake in the market for insulin. The free-market approach to drugs and other medical
products that operates in the U.S. presumes that the same forces at work in the markets for CocaCola and iPhones are at work in similar ways
in the markets for insulin and other healthcare products.205 As discussed previously, the free-market approach has undoubted advantages,206
but the
ethical implications of letting the market decide who can afford insulin and who cannot should
not be ignored. A reduction of protection for an already immensely profitable industry207 would ease the
burden on people who rely on insulin for survival. On the other hand, this approach does have drawbacks. For example, as
with any limitation on intellectual property protection, there is the concern that this would decrease
incentives to innovate.208 Insulin makers may decide to slow or halt development of costly new products if they fear that they will not
be able to recoup their losses.209 However, this particular issue seems to be of less concern here than in other situations in which
cutting edge biologics are not yet on the market. Insulin’s age and long history in the market will likely shield it from
this negative effect because several safe and effective varieties already exist. Thus, while reducing trade secret
protections for biologics may have the effect of making some drug manufacturers more reluctant to develop entirely new biologic drugs, it will
likely have the opposite effect of improving competition for drugs that are already on the market. Furthermore, a compromise might be made
to restrict the scaling-back of trade secret protection to insulin alone, rather than to all biologics. Using insulin as a sort of pilot for a broader
scheme of reducing trade secret protections in the pharmaceutical industry would provide lawmakers and the public with some context for the
effectiveness of such a scheme. A second potential drawback to this proposal is the possibility of a chilling effect on insulin production in
general. Once information about manufacturing insulin enters the public domain, regulatory agencies like FDA will have the ability to set
manufacturing standards accordingly.210 The more that is known about a substance, the easier it is to regulate.211 An increase in the
minimum standard may raise production costs, thus deterring current producers from continuing to make insulin, and discouraging new firms
from entering the insulin market in the first place. Trade
secrecy has kept the barriers to entry high for competitors in
the insulin market.212 There is no question that, in general, insulin and other biologics are more difficult and more expensive to produce
than chemical medications.213 Thus, the U.S. is unlikely to see drastic price reductions for these products such as those that resulted from the
enactment of Hatch-Waxman.214 However, the current situation is clearly untenable for patients, and a
secrecy in the insulin market would likely help facilitate price reduction. VI. CONCLUSION
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scaling back of trade
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Newer insulin isn’t better then old insulin
Belluz 19 [Julia Belluz, Vox's senior health correspondent and Knight Science Journalism fellow at MIT
with a MSc from the London School of Economics, 4-3-2019, "The absurdly high cost of insulin,
explained," Vox, https://www.vox.com/2019/4/3/18293950/why-is-insulin-so-expensive]/Kankee
“As solutions to the insulin-cost crisis are being considered,” a new New England Journal of Medicine editorial argues, “there is value in
remembering that when the patent for insulin was first drafted in 1923, Banting and Macleod declined to be named on it. Both felt that insulin
belonged to the public. Now, nearly 100 years later, insulin is inaccessible to thousands of Americans because of its high cost.” Most patients
with diabetes remain vulnerable to the whims of drug company pricing, since companies can still set whatever prices they wish. And no drug is
better for understanding how that happened than insulin. How the companies justify their price increases With Type 1 diabetes, which affects
about 5 percent of people with diabetes in the US, the immune system attacks the insulin-producing cells in the pancreas, leaving the body with
little or none of the hormone. In Type 2 diabetes, the pancreas still makes insulin, but the body has grown resistant to its effects. In both cases,
patients rely on insulin medication to keep energy from food flowing into their bodies. The
US is a global outlier on money spent
on the drug, representing only 15 percent of the global insulin market and generating almost half of the
pharmaceutical industry’s insulin revenue. According to a recent study in JAMA Internal Medicine, in the 1990s
Medicaid paid between $2.36 and $4.43 per unit of insulin; by 2014, those prices more than tripled, depending on
the formulation. The doctors and researchers who study insulin say it is yet another example — along with EpiPens and
decades-old generic drugs — of companies raising the cost of their products because of the lax regulatory
environment around drug pricing. “They are doing it because they can,” Jing Luo, a researcher at Brigham and Women’s
Hospital, told Vox in 2017, “and it’s scary because it happens in all kinds of different drugs and drug classes.” In countries with single-payer
health systems, governments exert much more influence over the entire health care process. In
England, for example, the government has
an agency that negotiates directly with pharmaceutical companies. The government sets a maximum price it will pay for a drug,
and if companies don’t agree, they simply lose out on the entire market. This puts drugmakers at a
disadvantage, driving down the price of drugs. The US doesn’t do that. Instead, America has long taken a free market
approach to pharmaceuticals. Drug companies haggle separately over drug prices with a variety of private insurers across
the country. Meanwhile, Medicare, the government health program for those over age 65 — it’s also the nation’s largest buyer of drugs —
is barred from negotiating drug prices. That gives pharma more leverage, and it leads to the kind of price surges
we’ve seen with EpiPens, recent opioid antidotes — and insulin. Insulin manufacturers say the increases are just the price tag that comes with
innovation — creating more effective insulin formulations for patients. According to a 2017 Lancet paper on insulin price increases, “Older
insulins have been successively replaced with newer, incrementally improved products covered by
numerous additional patents.” The result is that more than 90 percent of privately insured patients with Type 2 diabetes in
America are prescribed the latest and costliest versions of insulin. But soaring prices for these newer formulations
is out of step with how much they improve treatment for patients, said Yale endocrinologist Kasia Lipska. For Type 1
diabetes, newer formulations appear to be more effective at controlling blood sugar than older formulations. “For Type 2 diabetes, it’s less
clear — the benefits are not as strong.” So, Lipska asked, “Are [the new insulins] 20 times better? I’m not sure.” Luo,
the Lancet paper’s lead author, doesn’t find the “cost of innovation” argument very convincing. In his research, he’s come across many
examples of the
same insulin products that have been continuously available for years without
improvements, yet their price tags have gone up at a much higher rate than inflation. “The list price of
these products are already out of reach for most Americans living with diabetes — in some cases, over $300 a vial,” he
said. “It is also strange to see Humulin still priced at over $150 a vial considering this product was first sold in the US in 1982.” Drugmakers do
this because they can So insulin’s drug pricing problem is much bigger than anything one state — or drug company — alone can fix. But more
changes in the market may be on the horizon. The three major insulin makers — Eli Lilly, Novo Nordisk, and Sanofi — testified before the House
Energy and Commerce’s oversight subcommittee last April, focusing more attention on the issue. Lawmakers, including Sens. Chuck Grassley (RIA) and Ron Wyden (D-OR), have also been investigating the problem and sending letters to drug companies asking them to account for their
outrageous price hikes. But while the pressure around insulin may be mounting, we’re also seeing the terrible impact of rising insulin prices on
patients: people being forced to taper off insulin so they can pay their medical bills, and winding up with kidney failure, blindness, or even
death. Some are forced to head to Canada, where drug prices are more heavily regulated and, according to the new NEJM editorial, where a
carton of insulin costs $20 instead of the $300 patients often pay in the US. “Of course, there isn’t enough insulin in all of Canada to make largescale importation feasible,” the editorial authors wrote. One real solution to the problem, however, would
be to bring a generic
version of insulin to the market. There are currently no true generic options available (though there are several
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rebranded and biosimilar insulins). This is in part because
companies have made those incremental improvements to
insulin products, which has allowed them to keep their formulations under patent, and because older insulin
formulations have fallen out of fashion. But not all insulins are patent-protected. For example, none of Eli Lilly’s insulins are, according to the
drugmaker. In those cases, Luo said, potential manufacturers may be deterred by secondary patents on non-active ingredients in insulins or on
associated devices (such as insulin delivery pens). There’s also “extreme regulatory complexity” around bringing follow-on generic insulins to
market, Luo added. And that’s something regulators, such as the Food and Drug Administration, have been working to streamline. History has
shown that their efforts are worthwhile: When
cheaper generic options are introduced to the market, overall drug
prices come down. A century after insulin was discovered, it’s about time we had one.
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Most diabetics that need insulin aren’t diabetic because of not eating right - focusing
on personal diet harms activism for diabetics
Pendergrass 18 [Drew Pendergrass, doctoral student in Environmental Engineering at Harvard
University, 01-22-2018, "How Insulin Became Unaffordable," Harvard Political Review,
https://harvardpolitics.com/how-insulin-became-unaffordable/]/Kankee
Diabetics have become a special target for this rebate scheme for a number of reasons. Over the past decade, the pool of rebatable drugs has
shrunk. According to testimony from Patricia Danzon, a professor at the University of Pennsylvania, the rise of generic drugs has forced PBMs to
rely on larger rebates from a smaller number of prescriptions to maintain the same profit margins. Because there is no generic insulin, PBMs
and insurers both have strong incentives to negotiate high list prices and rebates from manufacturers. Diabetics
have other
vulnerabilities that can be exploited by these organizations. One is obvious: Type 1 diabetics will die without
their insulin, and they die quickly. This makes patients nervous when challenging massive multinational corporations with little
government help. “It’s important here to understand how hard it is to stand up for civil rights and consumer protections in relation to powerful
entities that that hold your life, or your child’s life, in their hands,” said Boss.
A lack of empathy The
public has stayed largely silent on insulin pricing issues. Industry has been successfully
able to blame people with diabetes for high drug prices, claiming that if people “maintain a healthy body
weight” drug prices would be lower. While it is true that Type 2 diabetes is linked to obesity, and that some Type 2 patients use
insulin, these narratives conveniently report list price expenses, not the actual rebated cost to insurers. With this
rhetorical flourish, attention is taken away from healthcare corporations and redirected towards patients
themselves. “There’s a lack of empathy there for all of us, Type 1 and Type 2,” said Peg Abernathy, a Type 1 diabetic and
activist, in an interview with the HPR. On Saturday Night Live last year, comedians joked that McDonald’s was offering
two versions of the Big Mac, one for each kind of diabetes. Besides being factually inaccurate—Type 1 diabetes
has nothing to do with body weight and Type 2 diabetes is triggered by a myriad of other factors, including
pregnancy and race — these comments underscore a culture of contempt in America towards long-term
health issues. Mick Mulvaney, the Trump administration’s director of the Office of Management and Budget, said last year that the
government should “provide that safety net so that if you get cancer you don’t end up broke,” but later added, “That doesn’t mean we should
take care of the person who sits at home, eats poorly, and gets diabetes.” This
narrative is one of the main reasons why
diabetes advocacy cannot get off the ground, while price increases for drugs like the EpiPen were met with wide public
outrage. “Americans tend to treat sudden catastrophic health crises (heart attack, cancer) as a matter of
bad luck, but chronic conditions like diabetes as a matter of bad choices,” said Boss. What lies ahead The United
States does not negotiate prices with drug manufacturers. The for-profit companies who are supposed to negotiate, PBMs, do so in their own
interests and not the interests of patients. Patients are left powerless, and are shamed publicly for their weakness. The winners in this game are
predictable. Alex Azar, president of Eli Lilly USA during its unprecedented insulin price hike, is now Trump’s nominee for Health and Human
Services. There is reason to hope—the FDA announced in December that they would expedite applications for a generic insulin. But unlike
traditional generics, the infrastructure necessary to produce insulin is complex, requiring factories of modified cells. Organizations like the Type
1 Diabetes Defense Foundation and the Juvenile Diabetes Research Foundation are fighting to share rebates directly with patients, cutting out a
cash cow for the industry. If the rebates are eliminated, US insulin prices begin to look more like those in Canada. But until something changes,
Americans like Alec Raeshawn Smith will lose their lives because they can’t afford a 100-year-old drug. “[Diabetes]
is a treatable,
manageable disease, and people shouldn’t be dying from it because they should be able to afford their
life-saving medication,” said Smith-Holt. “Without it they die.”
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Contention 2: Innovation
Medical innovation in crisis – rarely do new drugs improve health outcomes due to
new patents being only marginally better then older drug
Naci et al. 15 [Huseyin Naci, assistant professor of health policy at the LSE Health analysis center at
the Department of Social Policy for the London School of Economics and Political Science , Alexander W
Carter policy fellow, at the Institute of Global Health Innovation, Imperial College London, Elias
Mossialos, professor of health policy, , at the LSE Health analysis center at the Department of Social
Policy for the London School of Economics and Political Science, 10-23-2015, “Why the drug
development pipeline is not delivering better medicines,” BMJ, https://scihub.se/https://www.bmj.com/content/351/bmj.h5542.full]/Kankee
Many in the
pharmaceutical sector suggest that the industry is in crisis. Industry analysts fret that financial rewards are
no longer sufficient for companies to maintain the investment needed to develop clinically useful drugs.1 Despite these
concerns, regulators in the US and Europe granted marketing authorisations to a record number of new medicines in 2014. However, the
majority of new medicines offer few clinical advantages over existing alternatives. We discuss how both
government and drug company practices contribute to the ongoing innovation deficit in the sector. Paucity of clinically superior medicines
Patients and clinicians commonly understand innovation to mean a medicine that has transformed
management and treatment,2 either by providing treatments for conditions with no current (satisfactory)
remedies or by offering meaningful improvement over existing options. In recent years, however, industry
analysts have adopted other definitions to measure innovation (box 1).3 Currently, the most common approach
to measure innovation is to count the number of new drug approvals.3 The number of drug approvals has
increased over the past five decades, culminating in 41 approvals in the US and 40 in Europe in 2014 alone; this compares with a
50 year average of 20 approvals a year.4 5 Large numbers of new drugs have been taken as a proxy for the
innovative capacity of the industry. Unfortunately, rather than new breakthroughs, most of the new drugs
are relatively minor modifications of existing treatments.6 Studies evaluating the clinical importance of
new drugs over the past decades consistently report a negative trend.7-11 Regardless of differences in analytical approach
and time period, all characterise only a minority of new drugs as clinically superior to existing alternatives.3
Luijn found that 10% of 122 new medicines on the European market between 1999 and 2005 were superior
to drugs already on offer.12 Among drugs reviewed by German authorities between 2012 and 2013, about 20%
were concluded to offer some benefit over existing alternatives and none was deemed to offer major
benefit.13 Between 1990 and 2003, only 6% of 1147 drugs approved in Canada provided a substantial
improvement over existing drug products,14 and Canadian authorities considered 10% of new drugs approved between 2004
and 2009 as highly innovative.15 Despite the paucity of clinically superior drugs, the pharmaceutical market grew by a factor of 2.5 in real terms
between 1990 and 2010 (fig 1⇓). Much of the increased expenditure on drugs was the result of increasing industry investment in “me-too”
medicinesrather than clinically superior medications.14 Drug companies have remained profitable over this period while the proportion of
health spending on drugs has increased and drugs have become less affordable.16 17 Over the past 30 years, firms lost their number one
position in the Fortune 500 ranking of US companies only in 2003, coming third behind oil and financial companies. In 2012, the top five
pharmaceutical companies included in the Fortune 500 earned over $50bn (£30bn; €40bn) in net profits.
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Repatenting old drugs wards off competition through endless monopolies and
deterring generic entry to the market – both harm innovation
Gurgula 20 [Olga Gurgula, lecturer of intellectual property law at Brunel University London, 10-282020, "Strategic Patenting by Pharmaceutical Companies – Should Competition Law Intervene?," IIC International Review of Intellectual Property and Competition Law,
https://link.springer.com/article/10.1007/s40319-020-00985-0]/Kankee
Strategic Patenting Impairs Originators’ Incentives to Innovate While originator companies typically argue that the
competition law intervention into their patenting practices will reduce their incentives to innovate,Footnote81 this article asserts that
strategic patenting itself reduces originators’ incentives. Thus, in a properly functioning system, when a patent protecting a
product is close to expiration the originator would be encouraged to innovate further in order to introduce a new product on the market and
maintain its competitive position. However, by
engaging in strategic patenting, the originator’s incentive to innovate
diminishes as it enjoys its monopoly position by merely procuring numerous secondary patents that shield
its current product from generic competition. Therefore, when companies engage in such strategic patenting,
they are merely protecting themselves from the competitive pressures that competition law aims to establish.
Maintaining that this practice is lawful, originators argue that strong patent protection is essential for recouping their investments, as well as
for incentivising them to engage in further innovation.Footnote82 Such a position may find some support in the arguments put forward by
Joseph Schumpeter and his followers, who claimed that since monopoly increases the reward of the innovator, monopolists are more prone to
innovation.Footnote83 However, as Lowe noted:Footnote84 the empirical evidence of the past few decades has worked against Schumpeter
and in favor of Kenneth Arrow, who contends that in favoring monopolies Schumpeter underestimated the incentives for innovation that
competition can offer. Monopolists tend to want to keep
their monopolies by resorting to any measures that can
keep new entrants out. Firms under competitive pressure from actual or potential competition, on the other hand, are
less complacent and know that inventing a new product is their best strategy for maintaining and increasing
their market share. In the same vein, the Commission emphasises the importance of competition for the incentives to innovate, stating
that: “[r]ivalry between undertakings is an essential driver of economic efficiency, including dynamic efficiencies in the
form of innovation. In its absence the dominant undertaking will lack adequate incentives to continue to
create and pass on efficiency gains.”Footnote85 Evidence from the pharmaceutical industry confirms that strategic patenting
reduces incentives to engage in genuine and meritorious innovation. In many cases, strategically
accumulated secondary patents are of marginal quality and are typically the result of routine research
activities.Footnote86 For example, in Perindopril the European Commission revealed that most of the secondary patents, procured
as part of the originator company’s anti-generic strategy, were seen by the company as “blocking” or “paper”, some of
which it considered involved “zero inventive step”Footnote87 and a purely editorial task.Footnote88 Moreover,
these follow-on pharmaceutical inventions are specifically timed around the expiration of the basic patent
and can be developed on demand.Footnote89 In AstraZeneca the Commission noted that the company designed to “[f]ile a patentcloud of mixtures, uses, formulations, new indications, and chemistry” in relation to its blockbuster product omeprazole to slow down generic
entry at a specifically defined time, close to the expiration of the basic patent.Footnote90 The main aim of these patents is to increase
uncertainty for generic companies as to the possibility of their market entry.Footnote91 Therefore, while many of these
secondary patents may be trivial and potentially invalid, the originator pursues them to protect its current
successful product from generic competition.Footnote92 Even if a company continues to engage in innovation
in parallel to pursuing strategic patenting, it still protects itself from the pressures of competition, which
would have forced the company to innovate faster and would thus provide consumers with better products
and/or access to cheaper generic versions earlier. As Ullrich argues:Footnote93 A slowdown in the transition of the new
medicines from the protected status of a proprietary medicine to the status of generic products manufactured and distributed in open
competition does not simply mean a loss of static efficiency, namely a loss of consumer well-being due to a slowdown in the reduction of
process. Rather, such a
slowdown also involves the risk of a loss of dynamic efficiency in that it extends the duration of a
monopoly rent situation, thus reducing the pressure to innovate more quickly. Following the rationale of the General
Court’s statement in AstraZeneca, the practice of the originator that extends its market monopoly by relying on the
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patent system “potentially reduces the incentive to engage in innovation, since it enables the company in a
dominant position to maintain its exclusivity beyond the period envisaged by the legislator”.Footnote94 Such practices,
according to the Court, act “contrary to the public interest”.Footnote95 Therefore, the practice of strategic patenting that protects
originators’ monopolies from competitive pressures and significantly reduces their incentives to engage
in genuine innovation is contrary to the rationale of the patent system, has a significant negative effect on competition and should raise
competition law concerns. Strategic Patenting Impairs Follow-on Innovation of Generic Companies Strategic patenting also has a
chilling effect on follow-on innovation by generic competitors in the form of developing alternative versions of an offpatent compound. As was discussed earlier, the expiry of a basic patent that protects an active compound facilitates generic competition. This
is because even
if the product is still protected by process, specific form or formulation patents, generic companies
may develop alternative ways of producing or formulating the product and start competing with the
originator. In the absence of strategically accumulated patents by the originator, generic companies are typically open to innovating to
launch alternative generic products as soon as the basic patent expires. However, by pursuing strategic patenting, originators
may discourage generics from engaging in follow-on innovation because of the uncertainty about the
patent protection and a fear of infringing on one of the numerous patents.Footnote96 In its Sector Inquiry Report,
the Commission cited the following quote from one of the originators: The entire point of the patenting strategy adopted by many
originators is to remove legal certainty. The strategy is to file as many patents as possible on all areas of the
drug and create a “minefield” for the generics to navigate. All generics know that very few patents in that
larger group will be valid and infringed by the product they propose to make, but it is impossible to be
certain prior to launch that your product will not infringe and you will not be the subject of an interim
injunction.Footnote97 Therefore, as a result of creating an impenetrable ring of patent protection by the
originator,Footnote98 generic competitors may be prevented from developing alternative generic versions of an
off-patent compound. One of the examples revealed by the Commission during its Pharmaceutical Sector Inquiry was the filing by an originator
company of “more than 30 patent families translating into several hundreds of patents in the Member States in relation to one product”, many
of which were filed after the introduction of the product.Footnote99 This affected the intentions of several generic companies that planned to
develop and bring their generic versions of the original product to the market.Footnote100 As a result, in addition to the already high barriers
to entry into the pharmaceutical market due to
patents that protect an existing product and the need to obtain a marketing
patenting raises these entry barriers further, making it very difficult for generic
companies to overcome them. This strategy, therefore, “may without further enforcement action by originator companies, …
delay generic entry until the patent situation is clearer or even discourage more risk-sensitive generic companies
from entering altogether”.Footnote101 Consequently, the fact that actual or potential competitors of originators would not be able to
develop alternative generic products means that no one could enter the market and challenge originators’ monopoly
positions. This results in a weakening of competition in the relevant market and a strengthening of the
originator’s already dominant position. As Maggiolino put it, “patent accumulation … may work as a pre-emptive
entry-deterrence strategy to protect monopoly power and … lower consumer welfare by allowing dominant firms to keep
on charging over-competitive prices”.Footnote102 Therefore, when an array of accumulated secondary patents “blocks
monopolists’ rivals from producing follow-on innovations, this strategy prevents the whole society from enjoying …
these further innovations”.Footnote103 While practices that facilitate innovation are encouraged by competition law, practices that are
authorisation, strategic
aimed at blocking follow-on innovation by competitors should raise competition law concerns. Strategic Patenting is Considered Lawful Under
the Current Approach
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Incremental changes increase average patent expiration dates, delaying generics and
competition for decades
Nawrat 19 [Allie Nawrat, journalist with a BS in history and politics from the University of York, 11-122019, "From evergreening to thicketing: exploring the manipulation of pharma patents," Pharmaceutical
Technology, https://www.pharmaceutical-technology.com/features/pharma-patentsmanpulation/]/Kankee
The Initiative for Medicines, Access & Knowledge (I-MAK) argued in a 2018 report titled Overpatented, Overpriced that the current system is
out of balance as “drugmakers have transformed the patent system in to a defensive business strategy to avoid competition in order to earn
outsized profits on medicines for many years beyond what was intended.” University of California (UC) Hastings Center for Innovation director
and distinguished professor of law Robin Feldman adds: “Patents
are supposed to last for a limited period of time. After that,
competitors should enter to drive prices down, but that’s not what is happening. Rather, drug companies
pile new protections on to their drugs to extend the protection cliff.” The two most common practices employed by
the industry to artificially extend protection, are ‘evergreening’ and ‘thicketing’, as Feldman describes them in a 2018 Journal of Law
and the Biosciences research paper titled May Your Drug Price Be Evergreen. They involve making small changes to branded
drugs – such as through modes of administration, new dosages and, as Scrip noted, even simply the colour of the drug itself
– which sometimes do not confer more therapeutic benefit to the patients. Feldschreiber acknowledges “there are
instances where it is very questionable as to whether slight changes to molecules do actually have an effect on
safety and efficacy” and “there is something wrong with that”. It can also encompass protecting certain steps in the production and
manufacturing process and recycling drugs for other similar indications. Some companies have also sought to find more creative
loopholes in the law to extend their monopoly over a drug. For example, to fight legal challenges to its patents, Allergan
transferred all patents for its eye drug Restasis to the St Regis Mohawk Tribe in September 2017, because the Native American tribe holds
sovereign immunity against intellectual property lawsuits. The deal was subsequently defeated in the US courts, with the Supreme Court
rejecting Allergan’s petition to appeal the case in April this year, but it’s a powerful example of the creative lengths some firms will go to extend
patent protection. Scale of pharma patent manipulation Feldman’s research, which looked at all drugs on the market between 2005 and 2015
and every instance where a company added a new patent or exclusivity, concluded “stifling
competition is not limited to a few
pharma bad apples. Rather, it is a common and pervasive problem endemic to the pharmaceutical
industry.” She found that 78% of drugs associated with new patents are not new drugs, but existing
ones, and almost 40% of all drugs on the market had additional market barriers through further exclusivities.
Although this manipulation trend exists across the industry, Feldman’s research found that manipulative extension practices
were particularly pronounced among blockbuster drugs. More than 70% of the 100 best-selling drugs between 2005
and 2015 had their protection extended at least once, with almost 50% receiving more than one
exclusivity extension. I-MAK’s 2018 report identified a similar trend among the 12 best selling drugs in the US in 2017; it found that the
drugs have an average of 38 years of exclusivity – almost double the 20 year original patent protection –
and an average of 125 patent applications. AbbVie and Humira: an example of bad behaviour One of the worst
offenders according to I-MAK is AbbVie’s anti-inflammatory blockbuster Humira. Both Feldman and Dutfield picked out Humira as a
particularly bad example of patent manipulation According to I-MAK’s 2018 report, AbbVie has filed 247 patent applications for
the drug in the US with the aim of extending its exclusivity for 39 years – 137 patents have been awarded to
date. This is in addition to 76 patent applications in the European Union and 63 in Japan. Humira is
currently the world’s best-selling drug and the second best-selling drug of all time – it has generated
around $100bn in sales for AbbVie since it was launched in 2002 and it is responsible for two-thirds of AbbVie’s
total revenue. I-MAK concludes that “AbbVie’s pricing practices are protected by an aggressive evergreening
patent strategy to extend the life cycle of Humira in order to deliberately delay competition.” These profits
are also connected to other practices by AbbVie that have led to the price of the drug increasing 18% every year between 2012 and 2016;
however, I-MAK concludes these are not consistent with rises in the price of manufacture or inflation. “Patents, like all good things, must come
to an end” Although she acknowledges that drug development is expensive and patents are “important for creating the possibility of reward for
that investment”, Feldman argues that these manipulations
mean “the cycle of innovation, reward, then competition
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is being distorted into a system of innovation, reward, and then more rewards”. She calls for a focus on
incentivising companies to focus on drug development through a “one-and-done approach, in which each drug invention receives one—
and only one—period of exclusivity” as “patents, like all good things, must come to an end”, and not be allowed
to be extended seemingly indefinitely. Dutfield suggests an alternative approach to incentivising drug R&D. “At the United
Nations, there are proposals that the costs of research and development should not be recouped through high
[drug] prices, but by other funding mechanisms in proportion either to the R&D costs, or to the global positive health impacts of the
medicines in question,” he explains. While there are concerns about where exactly these ‘other funding mechanisms’ would come from, this
approach could help to resolve an unbalanced patent system and ensure proper rewards for genuine
innovation in disease areas or drug types where there is less potential profits, such as antibiotics and
vaccines against healthcare crises primarily affecting developing countries.
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Corporations patent biotech they won’t use so rivals can’t use it to compete with
them
Gubby 19 [Hellen Gubby, professor at the Rotterdam School of Management at Amarus University
with a PhD in law, 9-6-2019, "Is the Patent System a Barrier to Inclusive Prosperity? The Biomedical
Perspective," Wiley Online Library, https://onlinelibrary.wiley.com/doi/10.1111/17585899.12730]/Kankee
As the economy has largely shifted from industrial manufacturing to high-tech, life science and information processing industries, intellectual
property has become more and more important. Corporations
have become increasingly aware of the potential of the
patent, not just as a shield to protect against imitation, but as a strategic tool to block competition and
dominate markets. Patents have come to have a broader strategic function in which innovation may only play a small part.
Although many patents do not produce any income: ‘In terms of strategy, though, the patent can be much more valuable’ (Macdonald, 2004, p.
143). Patent strategy is directly related to the business context. The Carnegie Mellon Survey of the US manufacturing sector in 1994 revealed
that firms
often used patents as strategic tools, rather than as simply a means of protecting an invention
from wrongful imitation (Cohen et al., 2000). In their examination of motives to patent, Blind et al. (2009) recognised that, although
protection from imitation was still the most important factor, ‘the importance of the strategic motives to patent are confirmed’ (Blind et al.,
2006, p. 671). Patent strategies The
decision to patent has become in part uncoupled from the original core purpose of the patent:
to protect an invention from unfair imitation by other market participants. Larger firms, with the capital
assets to pay for the cost of patenting, use their patent portfolios strategically. Patents have become
useful as bargaining chips; they provide leverage. Large patent portfolios are a means to get access to
important co-operations or cross-licensing arrangements (Blind et al., 2009, p. 431). Yet while building the portfolio
requires enormous legal costs, it contributes little to research incentives. Furthermore, these portfolios can be used not
just to oblige competitors to take licences, but also the terms of these licences can restrict competitors to certain areas of
technology (Barton, 2000). Larger firms can afford to play the ‘wrap around’ strategy. Instead of applying for a single patent to
cover an invention, other patents are filed around the main patent. These related patents lock down the discrete
features of an invention. The tactic hinders entry to the market. Competitors will be put to time, effort
and cost to fight their way through all the relevant patents covering the technology. Furthermore, the
chance that the competitor's invention may infringe one of the many claims in one of the many patents is
high. Not only can damages be awarded for infringement, but also an injunction. Injunctions prevent the
party accused of infringement from producing any products that require the use of the technology
covered by the infringed patent and all infringing products are removed from the market. Patents may be
used simply to block competitors. Using a patent as a blocking strategy is common practice (Neuhäusler, 2012).
Defensive blocking is used to protect a firm's own freedom to operate: it does not want to be shut out
by the patents of its rivals. An offensive blocking strategy is where patents are filed to cover products or processes
that the firm does not intend to practice itself, but which could be viable alternatives to competitors. By
patenting all conceivable alternatives, research by competitors that might threaten their own
technological lead can be thwarted. As in general a patentee is under no obligation to license out its
technology to another, the strategy can deter market entry or new product launch. This offensive blocking of
competitors by means of patents, ‘is clearly a case of the patent system being used for purposes other than for which it was originally
intended’ (Blind, 2009, p. 436). However, both defensive and offensive blocking should be a policy concern, as they can reduce
economic efficiency. Defensive patenting increases cost to firms without necessarily producing any
benefit and offensive patenting can reduce technological progress and increase consumer costs by
reducing competition (Thumm, 2004, p. 533). Using data from a large-scale survey of patent applications, Torrisi discovered that a
substantial share of patents remained unused and a substantial number of patent applications were
filed to block other patents. There were institutional differences; there were more unused patents in Japan and the EU than in the
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USA. Although cautious to make generalisations about unused patents, as some unused patents are there to ensure freedom to operate or
simply because of management inefficiency, Torrisi et al. did conclude that: ‘[o]ur
results highlight that there might be
substantial benefits that patent owners draw from being able to keep patent rights unused. These would
have to be balanced against possible harm imposed on other economic agents’ (Torrisi et al., 2016; , p. 1384). These strategies show a
disconnect with the original purpose of the patent system. Patent strategies impact on innovation, and this in turn impacts on society. Concern
was already expressed quite forcibly some years ago by Turner: Surely when the framers of the [US] Constitution empowered Congress to grant
monopolies to ‘promote the progress of science and the useful arts’, they did not envision the beneficiaries of this grant would use it to bury
new technologies to protect market share or capital investments. (Turner, 1998, p.209) Administrative failures Patent offices have been
struggling to cope with the increasing number of patent applications: in 2017, more than 3 million patent applications were filed worldwide
(WIPO, 2018). This influx has resulted in substantial application backlogs, with an increasingly long time between the patent filing and the
patent grant: five years is not unusual. Complaints of poor quality control have been made concerning the US Patent and Trademark Office as
well as the European Patent Office (Abbott, 2004; Mabey, 2010). The WIPO recognised a consistent upward trend in patent filings is putting
patent offices under enormous pressure (WIPO, 2017, p. 13). Why are these administrative failings dangerous from a societal perspective?
Patents grant a monopoly that can impact innovative processes for 20 years or more. Patents have been
granted that should not have been granted. When an overly broad patent is granted, this can block
further innovation by others. Broad patents may mean that access to vital research is not available
because the results of that research are covered by patent claims. In particular, broad basic patents on fundamental
research can block and deter follow-on research. The incentive to innovate is reduced (Barton, 2000; Henry and
Stiglitz, 2010).1 Back in 1966, the societal implication of overly broad grants was expressed clearly by the US Supreme Court when it rejected a
broad claim covering a group of chemicals: ‘Such
a patent may confer power to block off whole areas of scientific
development without compensating benefits to the public.’2
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Patents also block fundamental research from rivals
Gubby 19 [Hellen Gubby, professor at the Rotterdam School of Management at Amarus University
with a PhD in law, 9-6-2019, "Is the Patent System a Barrier to Inclusive Prosperity? The Biomedical
Perspective," Wiley Online Library, https://onlinelibrary.wiley.com/doi/10.1111/17585899.12730]/Kankee
3 The exclusionary effects of patent system manipulation: the biomedical sector Biotechnical inventions have a fundamental impact on
healthcare, with applications in medical diagnosis, research tools and pharmaceutical drugs. Knowledge has
become a very
valuable asset. Its commercialisation opens up lucrative business opportunities. The strategic use of patents in the biomedical sector is
intended to protect those business interests. However, those patent strategies have societal repercussions. Intellectual property rights and
biomedical research A
common argument is that there is a distinction between fundamental research and the
application of that research; fundamental research should remain in the public domain, while applications can be the province of patents.
That is a misguided distinction. As Eisenberg and Nelson point out, the conventional view that basic research is a public enterprise
while applied technology is a private enterprise conducted in the hope of earning profits, ignores the ways in which basic science
and applied technology can frequently overlap: public and private interest may then conflict (Eisenberg and
Nelson, 2002). Fundamental research can become proprietary. A patent should only give protection to an
invention. According to US law, this invention must be ‘useful’ (35 US Code, Section 101) and the European Patent Convention 1973
(EPC) requires that an invention is capable of ‘industrial application’ (Art. 52, EPC). Patent law therefore mandates that there must be a
practical application. Consequently, a patent does not extend to a discovery, the terrain of fundamental research, as
this is explicitly excluded from patentability. The line between ‘discovery’ and ‘invention’ has, however,
become exceedingly thin, if non-existent, with respect to molecular technology. The current position with regard to genes and DNA
sequences in effect marks a departure from the traditional doctrine that excluded discoveries from patentability. Genes are not new
products; they exist in nature and therefore cannot be invented. Yet today, genes and gene sequences are
patented as inventions, being regarded as ‘products’. Even if a use of the gene or sequence is speculative, if a use is
plausible at the time the patent is filed the utility requirement is fulfilled. The EPC was amended to be brought into
line with the terms of the European Directive on the legal protection of biotechnological inventions. This Directive states: An element isolated
from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may
constitute a patentable invention, even if the structure of that element is identical to that of a natural element.3 Taking an apparently different
track, in 2013 the US Supreme Court stated that the mere act of isolating a gene from its surrounding genetic material was not an act of
invention. The court did accept synthetic cDNA as patentable, as this was created in the laboratory.4 Scientists
have voiced concern
that what is often patented has not so much been produced but rather discovered, and is human genetic
information rather than an invention (see for a summary of some of these arguments Bergel, 2015). These developments in
patent law have created a very real danger: researchers could be barred from accessing fundamental research,
which in turn could hinder new knowledge and further innovation. Back in 1998, Heller and Eisenberg warned policy makers
to be alert: more upstream rights could block downstream innovation. In this way, the private ownership of
biomedical research could lead to fewer useful products for improving human health (Heller and Eisenberg, 1998). If
genes and DNA sequences are patent protected, then the patent owner has the right to exclude all
others from using that technology. This breach of the discovery/invention distinction is symptomatic of the
expansion of patentable subject matter at a global level, extending property claims deep into biology and
limiting the scope for accessible treatment and future research (David and Halbert, 2017). The danger of private
ownership of fundamental research became apparent with the commencement of the Human Genome Project in the 1990s. The project turned
into a struggle between publically funded scientists and private companies. Publically funded scientists worked hard to ensure that all their
research would remain in the public domain and therefore published all their findings to prevent patent applications blocking access to
research. Their attempts were not always successful. For example, one day before Mike Stratton was due to publish his paper on cancer genes
in the journal Nature in 1995, the private company Myriad Genetics applied for a patent on BRCA1 and BRCA2, which were associated with
breast cancer. The patents allowed it to charge for tests at a cost of $2,500 per patient. Licences for the use of its simpler tests for breast cancer
by other labs cost several hundred dollars per patient, a cost that, given the nature of the American healthcare system, meant the test was not
available for all female patients in the USA. By 2015, Myriad was worth over $3bn (Pollock, 2018, p. 64). The leading
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patent offices,
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those in
the USA, Europe and Japan, have granted thousands of patents claiming human DNA. Patent
thickets have already emerged, with many of the sequences claimed in patents overlapping. For example, a gene
with 15 exons could have a separate patent on each exon; there could be a claim on the complete
sequence, as well as a claim on the promoter sequence. One illustration of the complexity of these overlapping patents is
the difficulties encountered by researchers from the PATH foundation when they were trying to develop a malaria vaccine: they had to
negotiate research use for the 39 different patents involved (Thomas et al., 2002). Thomas also points to the dangers of broad patents grants:
‘Furthermore, because
the majority of patents covering DNA sequences are what are termed per se claims,
the applicant, in making the first claim, gains the right to all uses, including those that are as yet
undiscovered’ and ‘[a]n excessively broad patent that contains claims to all conceivable diagnostic tests
creates a monopoly, such that there is little incentive to develop improved tests’ (Thomas et al., 2002, pp. 1186–1187). Some
commentators are not convinced that patent monopolies have hindered follow-up research. Clark states that there is a lack
of evidence that intellectual property protection measures have had a significant negative impact on academic biomedical research: ‘In the face
of no empirical evidence, the myth that patents inhibit biomedical research, publication and dissemination of knowledge is promulgated’ (Clark,
2011, pp. 79–80). Caulfield et al. (2006), while acknowledging that there have been good reasons for concern, like Clark concludes ‘the feared
problems have not widely manifested’. However, Caulfield et al.'s research does point to one important exception: gene patents that cover a
diagnostic test. Patent owners have asserted exclusivity or licence terms ‘widely viewed as inappropriate’ (Caulfield et al., 2006;, pp. 1892–
1893). The assertion of ‘no empirical evidence’ is certainly too strong. Examples of problematic access to fundamental technology do bubble to
the surface. One such example is the position regarding zinc-finger proteins (ZFPs), which can bind almost all DNA sequences. The ZFP patent
portfolio has been dominated by one firm in particular: Sangamo. Researchers found that Sangamo was highly selective in its choice of
collaborators. Academic scientists therefore often took the risk of using the technology without a licence, hoping that Sangamo would not sue
academics. However, even this did not solve the problem. The patents did not disclose all the necessary information. Vital knowledge remained
in the Sangamo database and design rule set. Without this proprietary information scientists could not practice the claimed invention: ‘More
complete patent disclosure might also have obviated the need to generate various open science alternatives to the Sangamo platform’
(Chandrasekharan et al., 2009). These examples should not be dismissed as ‘anecdotes’; they are important. They indicate that access by
academics to fundamental research can be hampered. Nor do we know how many innovative start-ups or small firms have been hindered by
blocking patents, too expensive licences, restrictive licence terms or threats of being sued for patent infringement. An assessment of the
situation cannot be made simply by looking at litigated cases: litigated cases are always the tip of the iceberg. The pharmaceutical industry
Pharma companies stress that medicinal drugs take years of research and development. The venture is also far from risk free: the drug may be
a failure either because clinical trials fail, so approval is not given, or because it is not a commercial success. Based on a study at the Tufts
Center, it has been estimated that the time needed for the development of a new drug, from initial stages through to approval, takes on
average 11.8 years and will cost in the range of $802 million to $1.8 billion (DiMasi et al., 2003; Barazza, 2014). It is these costs, the industry
argues, that justify the high price of the drugs. In a critique of the methodology used by the Tufts Center to explain a cost of $802 million, and
the lack of public access to the data used for the study, Light and Warburton argue that such estimates should be treated with scepticism; these
are ‘mythical costs’ to try to justify the high prices of drugs (Light and Warburton, 2011). What is clear is that if the drug survives the patent
process and the authorisation process, and turns out to be a blockbuster, huge profits can be reaped. For example, the Danish company
Lundbeck grew rapidly in the 1990s primarily because of its anti-depression drug, Citalopram. Citalopram alone accounted for around 80 per
cent of the company's sales by the end of the twentieth century, with large sales figures for Europe and the USA at that time bringing in kr. 720
million.5 Similarly, Losec, a medicine for stomach ulcers, was so successful that it is estimated to have brought in between $15–30 billion for
AstraZeneca, making AstraZeneca one of the largest global pharmaceutical companies (Granstrand and Tietze, 2014). Many
pharmaceutical companies have not been reticent to exert their monopoly position to ensure market
dominance and satisfy their investors. However, with some exceptions, a patent expires after 20 years. When the patent expires,
the market for the drug opens up to generic drug companies. These generic drug manufacturers have not had to sustain the costs in
development of the original brand manufacturers. This means that they can sell generic medicines considerably cheaper: on average 25% lower
than the price of the brand drugs at the time of generic entry and 40% lower two years after entry. The share of the market by generic
companies after two years is estimated at 45% (European Commission, 2009: paragraph 1560). It is not surprising, given the huge profits that a
blockbuster drug can make for a company, that pharma
companies will look to manipulate the patent system to prolong
their market dominance. The brand name drug companies have various strategies they can employ. They can wrap many
patents around the original patent, resulting in patent clusters. Patents are filed for certain specific
aspects of a single product, such as dosing, delivery systems and combinations. For example, depending on the
medicine, the medicine may come with a proprietary inhaler or injector that is integrated into the product. Yet these combinations will be
patented separately. Consequently, even after all the patents on the medicine expire, the remaining patents on the associated device, or parts
of the device, can be sufficient to prevent generic entry (Beall et al., 2016).
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Patent thickets/evergreening make it impossible for generic market entry, reenforcing
drug monopolies
Bluhm 19 [Michael Bluhm, educator at GWU for IR with PhD, 12-2019, “The Role of Monopoly in
America’s Prescription Drug Crisis,” Open Markets,
https://static1.squarespace.com/static/5e449c8c3ef68d752f3e70dc/t/5ea4d29f9bc8f31a1117feec/1587
860128096/WhitePaper_DrugPrices_Bluhm.pdf]/Kankee
THICKETS OF EVERGREEN PATENTS Drug manufacturers retain the exclusive rights to produce and sell a patented drug during the 20-year
length of a patent. To be fair to pharmaceutical firms, they generally patent new drug formulations during clinical trials, so drugs coming to
market usually wind up with an average of 8 to 12 years of patent protection remaining.71 But drugmakers today rarely
apply for
only a single patent for their new drugs. Instead, they game the regulatory system by registering thickets of similar
patents around a single brand drug for minor tweaks devoid of innovation. These patent thickets lock in
monopoly rents well beyond the 20 years of patent protection. Drugmakers deploy multiple,
overlapping strategies to abuse the patent system this way. Pharmaceutical firms commonly file additional patents
for individual features of a product, such as isomers, polymorphs, metabolites, or intermediates.72 Drugmakers also claim
patents for minimal variations in methods of use, dosage schedules, or the method of manufacture.73 The bases for these patents
might sound dubious, but any potential market competitor would have to go through expensive, lengthy litigation
to challenge a single patent.74 To ward off competition, drugmakers cobble together a complex scaffolding of patents around each
brand drug. The scope of the abuse of the patent system is breathtaking. Almost 80 percent of drugs receiving U.S. patents
from 2005 to 2015 were not new drugs, but drugs that already enjoyed patent protection.75 The total
number of additional patents for existing drugs soared from 349 additional patents in 2005 to 723
additional patents in 2015.76 More recent data show a stark increase in drugs with multiple patents and exclusivities.77 As of 2018,
almost 40 percent of all drugs on the market had walled off competition through multiple patents or
exclusivities.78 Almost half of all available drugs were shielded by at least four additional patents, and
some drugs were cocooned by more than 20 additional patents.79 Drugmakers build patent thickets to extend
monopoly rents, and this motivation is obvious in the size of the thickets protecting best-selling drugs. A blockbuster drug usually brings in
billions of dollars each year in revenue, so extending monopoly
protection by even a few months will produce
hundreds of millions of dollars in extra revenue.80 Each of the 12 best-selling drugs of 2018 was shielded by an
average of 71 patents and 125 patent applications, with three of the 12 drugs having more than 200 patent applications.81
Thanks to these dozens of patents, each best-selling drug had, on average, an effective patent protection period of 38
years, nearly double the 20-year monopoly granted by a patent.82 Because all 12 drugs remain under patent protection,
these total numbers of patents and years of monopoly could still grow. Industry insiders also refer to this practice as evergreening, when
drugmakers claim fresh patents for drugs whose original patents are about to expire. Similarly, drug
manufacturers also engage in producthopping, when they marginally change a product shortly before its patent expires, and then they pressure
doctors to prescribe the newer version, to keep patients from using a generic alternative to the original brand formulation.83
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Squo innovation doesn’t help patients as monopolies remove incentives for
improvements
Feldman et al. 8-10 [Robin C. Feldman, researcher at University of California Hastings College of the
Law, David A. Hyman, researcher at Georgetown University Law Center, W. Nicholson Price II, University
of Michigan Law School researcher, and Mark J. Ratain, researcher at The University of Chicago, 8-102021, "Negative innovation: when patents are bad for patients," Nature Biotechnology,
https://www.nature.com/articles/s41587-021-00999-0]/Kankee
Incentives in patent law have driven innovation into spaces that are affirmatively harmful to patients, and patentees are discouraged from
taking steps to improve the product so as to prevent adverse health outcomes. Patent law in the United States is historically premised on
advancing the interests of society. From the store of productive activity available to all, the government restricts some activities for a limited
time in hopes this will redound to the benefit of all by incentivizing innovation1. The law thereby restricts
competition, forgoing
the concomitant advantages of the free market, but only during the patent period. After that time, the law expects that
competition will enter, driving down prices and spurring new innovation. From this perspective, US patent law centers on the benefit to the
public, with the inventor’s reward providing the vehicle for accomplishing this jurisprudential goal. In the health care space, these incentives
have resulted in extraordinary success stories, but the same incentives can also result in a range of undesirable consequences, including
excessive development of similar (but not better) products (‘me-too drugs’), the focus on drugs for diseases
that affect wealthy people and wealthy countries rather than diseases that disproportionately affect the poor and developing
nations, and a lack of innovation for types of medicines that may return fewer profits, such as antibiotics2,3,4.
Similarly, drug companies will not research the utility of a known (and hence unpatentable) chemical, since the
ability to obtain patent protection is central to their business model5. Past literature has highlighted these problems but has
largely overlooked the problem of ‘negative innovation’, in which patent law drives innovation into spaces that are
affirmatively harmful to patients. By this, we mean scenarios whereby patents create incentives to bring a product
to market in a way that is relatively harmful to consumers, and the existence of a patent (and the associated rents)
discourages the patentee from taking steps to improve the product so as to prevent the adverse health
outcomes. Of course, there are other patent-driven situations of problematic utility, including scenarios that result in purely
financial harms, such as drugs that are no better than existing options but are more expensive; scenarios
where a small, heightened risk of direct physical harm is offset by lower prices for the drug in question6; and
scenarios where there is no existing product on the market and inadequate incentives to develop such a
product, so any physical harm is the result of the underlying disease or illness7. Finally, there is a general concern that inadequate
new information about existing products is generated in the current system8. All of these scenarios are different in
kind from negative innovation, which results in a harmful (but profitable) product. We focus on this dangerous but
overlooked space of the patent landscape, wherein patents themselves lead fairly directly to patient harm. What does
negative innovation look like? We highlight a particularly pernicious example, the case of Imbruvica (ibrutinib); suggest the likelihood of
broader problems; and outline various strategies for preventing such outcomes going forward. The case of ibrutinib
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Anticompetitive practices allow monopolies to charge artificially outrageous costs that
hurts consumers
Rajkumar 20 [S. Vincent Rajkumar, Professor of Medicine at the Mayo Clinic, 2020, “The high cost of
prescription drugs: causes and solutions,” Blood and Cancer, https://www.nature.com/articles/s41408020-0338-x]/Kankee
Global spending on prescription drugs in 2020 is expected to be ~$1.3 trillion; the United States alone will
spend ~$350 billion1. These high spending rates are expected to increase at a rate of 3–6% annually
worldwide. The magnitude of increase is even more alarming for cancer treatments that account for a large proportion of prescription drug
costs. In 2018, global spending on cancer treatments was approximately 150 billion, and has increased by >10% in each of the past 5 years2.
The high cost of prescription drugs threatens healthcare budgets, and limits funding available for other
areas in which public investment is needed. In countries without universal healthcare, the high cost of prescription drugs
poses an additional threat: unaffordable out-of-pocket costs for individual patients. Approximately 25% of
Americans find it difficult to afford prescription drugs due to high out-of-pocket costs3. Drug companies cite
high drug prices as being important for sustaining innovation. But the ability to charge high prices for every new drug
possibly slows the pace of innovation. It is less risky to develop drugs that represent minor modifications of
existing drugs (“me-too” drugs) and show incremental improvement in efficacy or safety, rather than investing in
truly innovative drugs where there is a greater chance of failure. Causes for the high cost of prescription drugs Monopoly The most
important reason for the high cost of prescription drugs is the existence of monopoly4,5. For many new drugs,
there are no other alternatives. In the case of cancer, even when there are multiple drugs to treat a specific malignancy, there is
still no real competition based on price because most cancers are incurable, and each drug must be used in sequence for a given patient.
Patients will need each effective drug at some point during the course of their disease. There is seldom a question of whether a new drug will
be needed, but only when it will be needed. Even some old
drugs can remain as virtual monopolies. For example, in the
United States, three companies, NovoNordisk, Sanofi-Aventis, and Eli Lilly control most of the market for insulin,
contributing to high prices and lack of competition6. Ideally, monopolies will be temporary because
eventually generic competition should emerge as patents expire. Unfortunately, in cancers and chronic lifethreatening diseases, this often does not happen. By the time a drug runs out of patent life, it is already considered
obsolete (planned obsolescence) and is no longer the standard of care4. A “new and improved version” with a
fresh patent life and monopoly protection has already taken the stage. In the case of biologic drugs, cumbersome
manufacturing and biosimilar approval processes are additional barriers that greatly limit the number of competitors that can enter the market.
Clearly, all monopolies need to be regulated in order to protect citizens, and therefore most of the developed world uses some form of
regulations to cap the launch prices of new prescription drugs. Unregulated monopolies
pose major problems.
Unregulated monopoly over an essential product can lead to unaffordable prices that threaten the life
of citizens. This is the case in the United States, where there are no regulations to control prescription drug
prices and no enforceable mechanisms for value-based pricing. Seriousness of the disease High prescription drug prices
are sustained by the fact that treatments for serious disease are not luxury items, but are needed by vulnerable patients who seek to improve
the quality of life or to prolong life. A high price is not a barrier. For serious diseases, patients and their families are willing to pay any price in
order to save or prolong life. High cost of development Drug development is a long and expensive endeavor: it takes about 12 years for a drug
to move from preclinical testing to final approval. It is estimated that it costs approximately $3 billion to develop a new drug, taking into
account the high failure rate, wherein only 10–20% of drugs tested are successful and reach the market7. Although the high cost of drug
development is a major issue that needs to be addressed, some experts consider these estimates to be vastly inflated8,9. Further, the costs of
development are inversely proportional to the incremental benefit provided by the new drug, since it takes trials with a larger sample size, and
a greater number of trials to secure regulatory approval. More importantly, we cannot ignore the fact that a considerable amount of public
funding goes into the science behind most new drugs, and the public therefore does have a legitimate right in making sure that life-saving drugs
are priced fairly. Lobbying power of pharmaceutical companies Individual pharmaceutical companies and their trade organization spent
approximately $220 million in lobbying in the United States in 201810. Although nations recognize the major problems posed by high
prescription drug prices, little has been accomplished in terms of regulatory or legislative reform because of the lobbying power of the
pharmaceutical and healthcare industry. Solutions: global policy changes There are no easy solutions to the problem of high drug prices. The
underlying reasons are complex; some are unique to the United States compared with the rest of the world (Table 1).Patent reform One
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the main ways to limit the problem posed by monopoly is to limit the duration of patent protection. Current
patent protections are too long, and companies apply for multiple new patents on the same drug in order
to prolong monopoly. We need to reform the patent system to prevent overpatenting and patent abuse11. Stiff
penalties are needed to prevent “pay-for-delay” schemes where generic competitors are paid money to
delay market entry12. Patent life should be fixed, and not exceed 7–10 years from the date of first entry into the market (oneand-done approach)13. These measures will greatly stimulate generic and biosimilar competition. Faster approval
of generics and biosimilars
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Low ROI from low antibiotic patentability makes the US vulnerable to ABR
Emanuel 19 [Ezekiel J. Emanuel, oncologist, a bioethicist, and a vice provost of the University of
Pennsylvania, 05-23-2019, “Big Pharma’s Go-To Defense of Soaring Drug Prices Doesn’t Add Up,”
Atlantic, https://www.theatlantic.com/health/archive/2019/03/drug-prices-high-cost-research-anddevelopment/585253/]/Kankee
Exorbitant drug prices have two bad effects. First, high costs mean that lots of patients are unable to take their medications. A recent study in
the Journal of Clinical Oncology assessed patients’ access to 38 different oral cancer drugs and found that 13 percent of cancer patients did not
buy approved chemotherapy drugs if they had a co-payment of $10 a month, while 67 percent did not when they had to pay $2,000 or more.
Another study showed that 25 percent of diabetic patient underuse their insulin because of cost. Second, the high
drug prices distort
research priorities, emphasizing financial gains and not health gains. Cancer drugs are routinely priced at about
$120,000 to $150,000 a year, and more than 600 cancer drugs are now being tested on humans. This can lead to great societal benefits: The
United States is expected to face 1.76 million new cancer cases and more than 600,000 cancer deaths in 2019 alone. But many of the drugs
that companies are pursuing have low promise, where the health gains are small—weeks of added life,
not big cures. While even this short extra time can be valuable to individual families, too much investment in oncology
means not enough in drugs for other illnesses whose treatments cannot be so highly priced. Consider
antibiotics. The Centers for Disease Control and Prevention ranks antibiotic-resistant infections as one of
the nation’s top health threats. An estimated 2 million Americans become infected with such bacteria
each year, and 23,000 die. A superbug that is resistant to all known antibiotics is an imminent threat. Yet
because antibiotics are generally cheap, for most pharmaceutical and biotechnology companies they are
not a primary focus. The Pew Charitable Trusts reports that only about 42 new antibiotics with the potential to
treat serious bacterial infections were in clinical development for the U.S. market in December 2018. Six hundred
drugs for cancer and only 42 for serious infections seems like profit maximization, not a case of sensible research priorities that reflects “value
in preventing and treating disease.” The simple explanation
for excessive drug prices is monopoly pricing. Through
patent protection and FDA marketing exclusivity, the U.S. government grants pharmaceutical companies a
monopoly on brand-name drugs. But monopolies are a recipe for excessive prices. A company will raise
prices until its profits start to drop. To address the problem of high prices and reduced access to drugs, Johnson & Johnson
advocates eliminating rebates to pharmacy benefit managers and insurers, which would increase price transparency and lower patient co-pays.
But it would not necessarily lower total drug prices. The proposal avoids the standard economic response to monopoly pricing: price regulation.
Every other developed country regulates drug prices, often through price negotiations pegged to cost-effectiveness analysis or some other
measure of clinical benefit. Will
R&D go down if the United States follows this model? Not necessarily. Remember,
the high drug prices fund R&D but also marketing, manufacturing, administrative expenses, and profits at the companies. Lower revenue
from lower drug prices could reduce marketing, administration, and excessive profits before R&D costs
have to be reduced. Where cuts are made is up to drug companies. Their claims of lower R&D costs appear designed to generate fear,
but as some former executives themselves have acknowledged, there is no necessary link between a decline in
drug prices and a decline in R&D. Drug companies could make other choices that maximally improve the health of all Americans.
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Pharmaceutical mergers don’t thump innovation – most R&D is from smaller firms
Shepard 18 [Joanna Shepherd, Professor of Law at the Emory University School of Law, 2018,
“Consolidation and Innovation in the Pharmaceutical Industry: The Role of Mergers and Acquisitions in
the Current Innovation Ecosystem,” Journal of Healthcare Law and Policy,
https://digitalcommons.law.umaryland.edu/cgi/viewcontent.cgi?article=1356&context=jhclp]/Kankee
However, concerns
about the impact of consolidation on drug innovation are largely based on an outdated
understanding of the innovation ecosystem in the pharmaceutical industry. Today, most drug innovation
originates not in traditional pharmaceutical companies, but in biotech companies and smaller firms, where a culture of
nimble decision-making and risk-taking facilitates discovery and innovation. In the later stages of the drug
development process, the biotech companies routinely partner with large pharmaceutical companies to
advance through expensive late-stage clinical trials and to effectively manufacture, market, and distribute
the drugs. In this current ecosystem, biotech and pharmaceutical firms are each able to specialize in what they do best, bringing expertise
and efficiencies to the innovation process. The specialization has led to an environment in which approximately threefourths of new drugs are externally-sourced. Internal R&D is no longer the primary source, or even an
important source, of drug innovation in large pharmaceutical companies. As a result, analyses that focus on mergers’
impacts on internal R&D and innovation are missing the point. Instead, proper analyses of the impacts of consolidation on
innovation should focus on whether consolidation enables firms to better support aggregate drug innovation in the current ecosystem.
Concerns about harm to innovation could be relevant in specific mergers or acquisitions if the consolidating firms are the primary innovators in
the area, the firms innovate internally, and there are essentially no sources of external innovation. However, such scenarios are increasingly
rare in the current ecosystem. As long as
there is sufficient market competition so that firms must innovate to
ensure their future profitability and market share, consolidation will often allow firms to devote more
resources to externally-sourced innovation. The increased demand for externally-sourced innovation
will, in turn, spur incentives to innovate in biotech and small companies. Indeed, data suggests that consolidation
is associated with increases in aggregate innovation. In recent years, aggregate innovation has held strong
notwithstanding dramatic increases in M&A activity; in fact, 2014 and 2015 generated both record numbers of new drug
approvals and record pharmaceutical M&A. Therefore, merger analyses that focus on the impact of consolidation on internal innovation
are incomplete because they fail to recognize that consolidation can increase demand for externally-sourced
innovation and, ultimately, strengthen aggregate drug innovation. This Article proceeds as follows. In Section II, I describe
the forces that have dramatically changed the pharmaceutical industry’s economic environment and driven many firms to consolidate. I also
explain the concerns, raised by both researchers and regulatory agencies, about consolidation’s potential harm to innovation. In Section III, I
explain the current drug innovation ecosystem, detailing the strengths of both traditional pharmaceutical companies and smaller, biotech firms
in drug discovery. In Section IV, I argue that proper analyses of mergers must focus not on the impacts to internal R&D, but on the impacts to
externally-sourced R&D and aggregate drug innovation. I conclude in Section V.
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Patents don’t cause innovation – secrecy and corruption thump any benefits
Zink 18 [Julie E. Zink, Professor at University of Dayton School of Law that has taught courses on
Intellectual Property Law, Trade Secret Law, and Patent Litigation, 2018, “When Trade Secrecy Goes Too
Far: Public Health and Safety Should Trump Corporate Profits,” Hein Law,
https://heinonline.org/HOL/P?h=hein.journals/vanep20&i=1183]/Kankee
III. THE NEGATIVES OF SECRECY Not surprisingly, there
are also negatives involved in protecting trade secrets-namely,
providing a legal shield that corporations can use to conceal nefarious activities. According to Bok, "[t]rade
secrecy is the most frequent claim made by those who want to protect secrets in business"; corporations may assert such claims to protect
legitimate secrets and, in some cases, to abuse or exploit their trade secret protections. 41 Trade secrecy can cause harm.
First, trade secrecy does not always promote one of its stated policy goals-innovation. 42 Rather, it encourages
companies to engage in duplicative investment in research and development. 43 It also frustrates the
disclosure goals of the patent system when companies opt for trade secrecy rather than patent protection.44
Second, secrecy debilitates judgment.45 If only a select few know the trade secret, then they are the only
ones who can make decisions regarding the information at issue. This postpones discovery of errors and
effectively shuts out criticism from others who may be able to provide valuable feedback.46 As a result, faulty
assumptions about risk may mean that little to no deliberation takes place regarding whether to continue,
modify, or cease use of the trade secret. 47 Third, secrecy has the capacity to corrupt and to invite abuse.
48 Due to others' lack of knowledge regarding the trade secret, those with knowledge operate in a
system free from oversight.49 This lack of accountability coupled with the desire for higher profits (for
which they are held accountable) results in a loosening of moral constraints.50 When no one is present
to hold a mirror up to their faces, they can downplay the consequences of their actions and disregard any
negative impacts the trade secret may have on their employees, their consumers, the general public, or the environment. IV. HISTORICAL
EXAMPLES OF TRADE SECRECY ABUSE
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Contention 3: Vaccine Apartheid
Without reducing vaccine IPR, millions in developing countries will die from the
current “vaccine apartheid” due to medical monopolies and a lack of access
Lennard 21 [Natasha Lennard, educator of Critical Journalism at the New School for Social Research
and Contributing Writer for the Intercept, 6-11-2021, "The G7 Upheld Vaccine Apartheid. Officials From
the “Global South” Are Pushing Back.," Intercept, https://theintercept.com/2021/06/17/vaccine-g7covid-internationalism-summit/]/Kankee
IF THE GROUP of Seven summit in the United Kingdom last week made anything clear, it is that those powers cannot
be trusted to
end the urgent crises facing life on Earth — for humans and nonhumans alike. When it comes to the Covid-19
pandemic, the G7 nation-states reaffirmed their commitment to global vaccine apartheid through
neoliberal governance, only slightly obscured under a guise of charitable offerings. The concessions are
insufficient at best. Amnesty International condemned the G7’s pledge to provide 1 billion doses to
middle- and low-income countries as a “drop in the ocean.” G7 leaders failed to agree to waive vaccine
intellectual property rules and commit to knowledge and technology sharing. Under the current medicine monopoly
regime, it is projected to take until 2078 for the world’s poorest countries to vaccinate their populations.
G7 countries are expected to vaccinate their populations by January 2022. Later this week, government
ministers from many of the countries that will suffer most — and have already suffered — from this abhorrent vaccine
inequality are convening online alongside scientists and global health advocates to forge a different path out of the pandemic. The summit,
hosted by Progressive International, recognizes vaccine internationalism as the necessary order of the day. Politicians from states including
Cuba, Venezuela, Vietnam, Kenya, Kerala — which is in India — and Argentina will attend, alongside Western parliamentarian progressive allies
like the U.K.’s Jeremy Corbyn and Greece’s Yanis Varoufakis. The question is whether a solidarity-based bloc can be established with sufficient
power and cooperation to undo vaccine apartheid. The stakes could not be higher. Covid-19
is all but assured to shift from a
pandemic into an endemic disease, with the victims of historic and ongoing colonialism left to die by
the millions. “We do not have a system that protects against unequal access,” Varsha Gandikota-Nellutla, an Indiabased coordinator with Progressive International, told me by email. She pointed to the disparities between the European Union and countries
in Africa. “Consider this: the
EU has already made a deal with BioNTech/Pfizer for 1.8 billion booster shots even as
the entire continent of Africa has vaccinated less than 2 percent of its population with the first and second
doses.” Gandikota-Nellutla noted that at current rates, it will take nearly six decades for the world to be vaccinated — a
statistic echoed by the People’s Vaccine Alliance, a coalition of organizations including Amnesty International, Health Justice Initiative, Oxfam,
Stop AIDS Campaign, and UNAIDS. She said, “We’re witnessing
the ills of nationalism, imperialism, and racial capitalism all play
out in the most grotesque of ways in the vaccine race.” WE KNOW WHAT vaccine nationalism looks like: Powerful countries, aided
by World Trade Organization regulations, make deals with leviathan pharmaceutical companies to buy up and
hoard vaccines. Poorer countries are forced into positions of dependence on insufficient charity; Big
Pharma gets bigger. Meanwhile, intellectual property fetishist Bill Gates asserts, despite evidence from international scientists to the contrary,
that poorer nations are per se incapable of developing, regulating, and distributing vaccines safely and efficiently. A
system of health
care scarcity is developed by design, with results no less than genocidal. The basic means of surviving a
pandemic are held as a political cudgel by the richest countries over the poorest. At present, for example,
Venezuela has been shut out of receiving any of the half a billion Pfizer vaccine doses President Joe Biden pledged
to donate to COVAX, short for COVID-19 Vaccines Global Access, the initiative purportedly committed to equitable international vaccine
distribution. Despite Biden stating that vaccine donations “don’t include pressure for favors or potential
concessions,” Venezuela has been shut out of COVAX access due to ongoing, brutal U.S. sanctions against the
country. “No country has the right to obstruct the access to health of any other,” Venezuelan Foreign Minister
Jorge Arreaza, who will be attending the Summit for Vaccine Internationalism, said in a statement. “Obstructing a people’s access
to vaccines during the pandemic is a crime against humanity and the free peoples of the world must
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unite and design mechanisms to avoid this medical apartheid, where a few have access to vaccines and others
are excluded.” ANY SORT OF robust vaccine internationalism — in which collective potentials for vaccine production and
distribution are truly unlocked — has so far been off the table. Yet we have seen a number of recent examples of production and
sharing outside the top-down control of powers like the U.S. and the EU. At the end of May, Mexico received its first batches of locally
produced AstraZeneca vaccines and sent half the consignment to its production partner, Argentina. Alongside establishing a stronger political
bloc to put pressure on Western nation-states and the WTO, the upcoming summit could see agreements made for future vaccine production
and sharing partnerships, which eschew precarious dependence on the world’s richest countries. “This is not going to be another talking shop,”
David Adler, general coordinator for Progressive International, tweeted, referring to the summit. “These governments are really coming
together to build something new — a system based on South-South cooperation, a serious plan to end the pandemic where the G7 refused to
find one.” As Gandikota-Nellutla told me, inspiration for the “New International Health Order” that the summit aims to create can be found in
the New International Economic Order first proposed in the 1970s. The plan, introduced by a number of poorer nations to challenge the postwar economic colonialism of the West, was adopted by the United Nations in 1974. As with vaccine internationalism, the idea of the New
International Economic Order was to foster greater cooperation between heavily exploited countries, while ensuring states’ sovereignty over
their resources, and a dramatic overhaul of the rules and procedures of unequal international trade, particularly as related to commodities.
Nearly half a century later, and aside from a few concessions, the plan has never been even close to fully realized; U.S. hegemony and the
neoliberal order of corporate globalization and extractivism won the day. The prospect of a New International Health Order may seem equally
beyond reach, yet the extraordinary circumstances of this pandemic have, in a number of ways, created openings for previously foreclosed
political economic shifts. In the U.S. alone, although too short-lived and too temporary, pandemic exigencies led to eviction moratoria and fair
unemployment benefits. The government leaders and advocates meeting to build vaccine internationalism are all too aware of the urgency of
the project. “Our very survival is at stake,” Gandikota-Nellutla told me. “Not only are we set on resolving vaccine access in our
countries in the present pandemic, but strengthening the foundations of a world order that will not allow such injustices to ever occur again.”
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A TRIPS waiver is key to counteract neoliberal capitalism and colonialism
Paremoer 21 [Lauren Paremoer, Senior Lecturer in Political Studies at the University of Cape Town
with a focus on global health governance, 3-11-2021, "A Pandemic of Vaccine and Technology Hoarding:
Unmasking Global Inequality and Hypocrisy," Cairo Review of Global Affairs,
https://www.thecairoreview.com/essays/a-pandemic-of-vaccine-and-technology-hoarding-unmaskingglobal-inequality-and-hypocrisy/Vaccine Apartheid ]/Kankee
Two words have been become commonplace in our conversations about the management of the COVID-19 pandemic: apartheid and solidarity.
The second seems to offer hope; the first, despair. Apartheid
is of course frequently used to describe the unequal
distribution of access to vaccines globally. Vaccine apartheid is a now-familiar shorthand used to highlight that as of June 23, 2021
more than 2 billion COVID-19 vaccine doses had been distributed globally, with the lion’s share of 85 percent
administered in high-income countries (HICs) and by contrast only 0.3% administered in low- and middleincome countries (LMICs). Vaccine apartheid is a predictable consequence of the unequal power relations
between states, particularly LMICs and pharmaceutical corporations, that was brought into being with the TRIPS regimen. This
imbalance in power relations was highlighted in the work of Susan K Sell, a Professor of Political Science and International Affairs at George
Washington University, who has written extensively on intellectual property and international development. In the early 2000s, she vividly
illustrated the importance of the human rights obligations of global pharmaceutical companies to allow the sick access to antiretroviral
medications. Mirroring
the racial apartheid of the South African regime prior to 1994, access to COVID-19
vaccines has been extremely limited in those parts of the world that historian Vijay Prashad has referred to as the “darker
nations”—those African and Asian countries which newly liberated themselves from colonialism and declared
their vision for remaking the world anew at the Bandung Conference of 1955. This vision of Third World internationalism shared at Bandung
centered on economic cooperation aimed at securing human welfare, anti-racism, and political solidarity. The interdependent nature of these
important principles was echoed in two other declarations that anchored the Third World political project: 1974’s the Declaration on a New
International Economic Order (NEIO) and the Alma Ata Declaration (1978). The close connections drawn between racial domination,
technological progress and political independence are particularly striking in the NIEO, which was adopted at the Sixth Special Session of the UN
General Assembly on May 1, 1974. The preamble of the NIEO declares that the international community wishes to “work urgently” to “make it
possible to eliminate the widening gap between the developed and the developing countries and ensure steadily accelerating economic and
social development and peace and justice for present and future generations”. Its opening paragraph frames technological progress as
something that can ensure the welfare of “the community of free peoples”, but that this potential is undermined in the context of “the
remaining vestiges of alien and colonial domination, foreign occupation, racial discrimination, apartheid and neo-colonialism in all its forms”
perpetuated by a “system which was established at a time when most of the developing countries did not even exist as independent States and
which perpetuates inequality”. The solution to this, the Declaration argues, is not simply more aid and greater technology transfer, but a
fundamental restructuring of political power within global governance structures. It calls for “active, full and equal participation of the
developing countries in the formulation and application of all decisions that concern the international community”. Like the NIEO, 1978’s Alma
Ata Declaration explicitly argues that the value of technological progress and the global economy lies, first and foremost, in the ability to
promote human welfare. Furthermore, it argues that promoting human welfare is unlikely to occur unless both technological progress and the
global economy are subject to political oversight, and in particular, democratic decision-making procedures at the global governance level that
include meaningful participation by the global South. Focusing on the right to health in particular, the Alma Ata Declaration emphatically
maintains that “The people have the right and duty to participate individually and collectively in the planning and implementation of their
health care”. These formulations are striking in their efforts to frame solidarity as a multi-dimensional and relational process that transforms
everyone involved in it. Former President of Mozambique Samora Machel said solidarity is “not an act of charity, but mutual aid between forces
fighting for the same objective” and involves both “political tasks and material support”. His words are striking because in the context of
vaccine apartheid, solidarity is more often framed as an act of giving by those who have to those who don’t, rather than a process. The ailing
COVID-19 Vaccines Global Access (COVAX) initiative is perhaps the most striking example of this approach to overcoming vaccine apartheid. It is
explicitly described as a “global solidarity initiative” and prioritizes providing material support to LMICs by subsidizing the price of vaccines for
eligible countries and attempting to pool procurement. This objective has been undermined by the rapacious behavior of countries in the global
North that have bypassed COVAX by using bilateral deals to purchase excessive amounts of vaccines in proportion to their population size—
effectively monopolizing access to the already-limited global supply of vaccines. This focus on material aid to countries that have been priced
out of the market for vaccines effectively reduced COVAX to a charity mechanism. Moreover, the marginal role of the World Health
Organization (WHO)—and its member states—in its decision-making structures ignores the “political tasks” that are necessary to enact
solidarity. COVAX does not aim to dismantle the IP
thickets that impede access to vaccines, and which have contributed to
an official global death toll that has currently surpassed 4 million people. It certainly does not aim to
dismantle the injustice created by the unequal control of money, power and resources that has intensified
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since the 1990s, and that reflects a longstanding extractivist orientation established in the colonial period, These have led
to COVID-19
disproportionately damaging the livelihoods and taking the lives of racial and ethnic minorities, women,
migrants, indigenous peoples, and the poor. As the extracts from the declarations above show, a commitment to this political
work was encoded in the forms of internationalism that led to, and were endorsed in the Bandung Declaration, NIEO, and the Alma Ata
Declaration. Social Vaccines The challenge then becomes how to address Third World concerns whether another more equitable mechanism is
possible. Endorsing the TRIPS waiver request submitted to the WTO by South Africa and India in October 2020 is one necessary
approach. The waiver has been challenged on the grounds that it will not make a meaningful difference in increasing access to vaccine supply in
the short-term, given that it will take some time for countries in the global south to build up local manufacturing capacity. A second argument is
that we don’t need the waiver, as existing TRIPS flexibilities are sufficient for addressing supply shortages. These arguments miss the political
and normative significance of the TRIPS waiver. The
power of the waiver is that it sets a legal precedent in favor of
prioritizing public good over profiteering, and it affirms this principle as non-negotiable and unambiguous
in the context of international trade, R&D, and manufacturing practices. To borrow from Austro-Hungarian economist Karl
Polanyi, it re-embeds the market in society, thereby introducing a significant normative shift in light of the neoliberal discourse that’s become
hegemonic in recent years. The
waiver, much like the important recommendations of the UN High Level Panel on Access to Medicines
released in 2016 (and since systematically erased from initiatives to reform the global R&D landscape for essential medicines), affirms that
the market works to promote collective wellbeing. It also creates legal certainty—something that currently
doesn’t exist when countries in the global South attempt to use TRIPS flexibilities. This is worth implementing because
the space created by discounting the threat of retaliation (on the grounds of alleged copyright
infringement) can create forms of collective action and collaboration that are currently not possible in the context
of the existing legal and political landscape. From a technical point of view, patents might thus seem to be a small impediment to accessing
vaccines. However, from
a political and normative point of view, an IP waiver on the copyrights, industrial designs,
COVID-19 diagnostics, therapeutics, and vaccines is potentially revolutionary,
as it reasserts political control over the market. This aspect of the waiver and the precedent it sets is perhaps why it is being
patents and undisclosed information relevant to
resisted at all costs by big pharma and some powerful countries in the global North. Law functions as an important mechanism for regulating
the interplay of public health and for-profit or private interest. The historical declarations cited above demonstrate that while legal
reforms are a necessary component of addressing this crisis, they are insufficient. As argued by Australian social scientist Fran
Baum, in addition to these reforms, an investment in “social vaccines” is needed: “A social vaccine is a process of social and political
mobilization which leads to increased government and other institutions’ willingness to intervene with interventions, applied to populations
rather than individuals, aimed at mitigating the structural social and economic conditions that make people and communities vulnerable to
disease, illness and trauma. While medical vaccines help develop immunity against disease, social vaccines develop the ability of communities
to resist and change social and economic structures and processes that have a negative impact on health and force governments to intervene
and regulate in the interests of community health.” The
vaccine apartheid has legalized racially based discrimination.
in a manner that means people suffer pain, discomfort, death and
permanent disability because they do not have the money to pay for patented medicines, and because
their governments cannot easily manufacture or import these medicines or their generic equivalents. The
hoarding of vaccines in the global North, their “gifting” to the global South, and the profound hesitancy to
support local manufacturing of a life-saving technology in these countries, are all part of a long and disturbing history
of global capitalism, which has allowed a small group of elites the power “to foster life or disallow it to
the point of death,” in the words of French philosopher Michel Foucault. It is exactly this necropolitics—this undemocratic
concentration of power which dictates how people live and die—that was supposed to be challenged by the multilateral
system born out of World War II and that the liberated nations of the Third World aimed to reshape. The TRIPS waiver offers an entry
point for reversing this tide and must be supported as a matter of urgency. In tandem, we need transparent, multilateral
mechanisms that allocate vaccines based on medical need—not purchasing power—and that allow governments
Today, the TRIPS regime is implemented
of the global south meaningful participation in decisions about collective procurement and allocation of global vaccines supplies.
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Current vaccine charity by developed countries isn’t enough- IPR reductions are key
Sariola 21 [Salla Sariola, educator of social sciences at the University of Finland, 04-01-2021,
“Intellectual property rights need to be subverted to ensure global vaccine access,” BMJ Global Health,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021739/]/Kankee
My response to their comment claims that though well intended and to the point, the commentary misses a crucial bottleneck in research and
development, namely, intellectual property rights (IPRs) that hinder the actualisation of global vaccine access. Instead of making vaccine
knowledge available openly, IPRs
protect industry benefits over human health and well-being. The current
arrangement is epidemiologically short-sighted and unjust. The brunt of vaccine capitalism is felt most in
LMICs and Africa in particular.2 Presently, philanthropic programmes to deliver vaccines to LMICs are not fast
enough, and a social movement is picking up speed to subvert IPRs that are upheld by rich countries at the World Trade Organization (WTO).
Global health communities need to take a stronger stance against IPRs that are protecting vaccine
pharma over the world’s poorest and leverage political will to make global vaccine access a reality. First, IPRs legitimate the
pharmaceutical industry to make exclusive decisions to whom vaccines are sold and at what price.
Under the Trade Related Intellectual Property Rights Agreement (TRIPS) by WTO, companies that own the intellectual
property hold exclusive rights to produce vaccines without competing generic products on the market. This
way, they are able to keep a foothold of the markets and the prices high, as there is little competition over
similar products. Vaccines currently on the market have been priced such that developing countries cannot
afford them. Prices may also vary depending on the contract: for example, contradictory to a social justice logic, the
AstraZeneca vaccine was sold to South Africa at $5.25 per dose but to EU at a lower rate of $2.16.3 The second
reason follows from the first. Availability of vaccines at national level is made possible via bilateral prepurchase
agreements between vaccine producers and countries or regions, such as the European Union or the African Union. The African Union,
with the help of the African Export-Import Bank, has negotiated an agreement to prefinance 670 million doses of vaccines while African
countries pool their funds,4 but still, very
few low-income countries have contracts that would provide sufficient
volumes to cover their entire populations.5 6 In short, different countries are not on an equal footing on
funding and networks in the negotiations, and the African Union has been a low priority. Third, the COVAX programme was
established in April 2020 to ensure that vaccines spread globally at equal pace after their licencing approval.
COVAX is often lauded as a mechanism that holds promise for just vaccine access, but its public representation is glossier than
the reality. COVAX is funded by various philanthropic funders and wealthy countries; it aims to cover 20%
of populations in countries that have funded it and to provide 1 billion doses across 92 non-funding
lower income countries.4 In December 2020, COVAX was close to failure due to insufficient funding,7 but one of
the first decisions by President Joe Biden’s new administration was to give its support to COVAX,8 which improved its chances of success.
Simultaneously, rich
countries such as Canada have grabbed vaccines through the COVAX programme.9
Canada has five times the number of vaccines required to cover its entire population.10 Due to the reality of
manufacturing rates, the surplus of some is at the expense of others, which brings to a sharp focus the
inherent inequality in how access is shaped by the purchasing power of countries where people happen to be
born. While the COVAX programme has commenced vaccinations for frontline carers in several lower income countries during February and
March 2021, the majority
of the populations in these countries have no vaccines in sight. The dynamic underscores
how COVAX is unable to remove global vaccine injustices and at worst reproduces differences between
the haves and the have-nots with a seeming guise of ‘doing something about it’. While COVAX is notable in its
charitable efforts, it remains a smokescreen for the IPRs issue at the heart of the inequity of vaccine
deployment. India and South Africa proposed to the World Trade Organization in October 2020 that a waiver of IPRs should be
mandated to guarantee international availability of vaccines under the exceptional pandemic circumstances.11 The
proposed waiver would see various aspects of the TRIPS agreement surrendered, denying pharmaceutical companies exclusive rights to
produce vaccines and benefit from their sales. The waiver would not only forego patents but various other aspects of IPR, such as trade secrets,
copyright, manufacturing knowhow, industrial design, blueprints and so on, that might get in the way of universal production. The motion is
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presently cosponsored or supported by
100 countries from two key groups at WTO: the Africa Group and the
Least Developed Countries Group.12 These are also the countries where vaccine gaps are felt most. The waiver has so far not been
accepted by the WTO. European Union, USA, UK, South Korea, Japan, Switzerland, Canada, Brazil, Australia and Mexico continued to oppose
the waiver in the most recent WTO meeting on 10 March 2021.13 14 The rationale by big pharma and countries that stand beside them
ultimately protects the interests of big pharma and its profit-based logic rather than the public. The proposed waiver is time bound and
restricted to products related to the pandemic but a more radical reformation could have profound impacts in how innovation is organised in
the future by questioning the capitalist modus operandi of vaccine production. Waiving
patents is not a radical or new
proposal. The most notable example is the use of compulsory licencing for cheap antiretrovirals in early
2000s. A social movement led by the South African NGO Treatment Action Campaign sued the South African government over the denial of
its citizens’ health rights and mobilised the Indian generic pharmaceutical company Cipla to produce cheap generics. The price of
antiretroviral medication (ARVs) was reduced by 97%, and with this, the HIV epidemic in Africa has been brought
under control.15 The campaign is not unique in its purpose: compulsory licencing is regularly applied in various situations, of which
epidemics are just one. However, since the 2000s, stronger patent barriers have been established, making it
harder to subvert patents. Compulsory licencing is not seen sufficient and timely enough for COVID-19
vaccines: it is slow because it requires separate negotiations between countries and companies, would
not provide access to key elements in production such as trade secrets, it maintains barriers for collaboration and
import and export of products and materials and does not cover future vaccines. The waiver would
remove any obstacles for global vaccine production, present and future. However, in the light of the opposition, it seems that
without a strong international movement and direct pressure, similar motion is unlikely. Organisations like Medicines Sans Frontiers, People’s
Vaccine Alliance, Third World Network and the European United Left at European Parliament have advocated the waiver, and it is time that
global health scholars worldwide stand with them. Conclusions Arguments to defend IPRs simply do not hold. The commonly presented
claim that IPRs protect innovator companies from market failure and financial risks do not apply in case
of COVID-19 vaccines because the research was done predominantly on public funding from various governments in
the Global North,16 which means that companies had to invest very little, and there continues to be an
enormous market for vaccines. COVID-19 vaccines should be treated as global public goods because at
present, the protections of IPRs to the vaccine companies are causing health and socioeconomic suffering
globally, rather than alleviating them. Delaying vaccine access for billions of people threatens the continuation of
the pandemic and development of further mutations. Global health communities need to join the motion and put pressure
on the WTO for when the waiver is discussed at the upcoming WTO meetings during the spring, lest allowing vaccine capitalism and apartheid
to endure.
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Compulsory licenses for vaccines fail – waivers are more effective for mass production
and collaboration
Correa 21 [Carlos M. Correa, Director of the Center for Interdisciplinary Studies on Industrial Property
and Economics and of the Post-graduate Course on Intellectual Property at the Law Faculty of
International Centre for Trade and Sustainable Development, "04-2021, “Expanding the production of
COVID-19 vaccines to reach developing countries Lift the barriers to fight the pandemic in the Global
South,” South Center, https://www.southcentre.int/wp-content/uploads/2021/04/PB-92.pdf]/Kankee
On the first argument, it is worth noting how intellectual property, particularly patents, relates to the production and commercialization of
COVID-19 vaccines. A study by the World Intellectual Property Organization (WIPO) found - already in 2012 – 11,800 patent families for
different components of vaccines to prevent some infectious diseases.13 113 patent families relating to the mRNA technology used by several
COVID-19 vaccines producers were identified in 2020; many of these patents have been applied for through the Patent Cooperation Treaty with
numerous States included, which means that these will enter to national phase processing in many developing countries.14 Moderna, Inc., the
producer of one mRNA based vaccine for COVID-19, is reported to hold “over 270 issued or allowed U.S. and foreign patents protecting
mRNAbased technology, with over 600 worldwide pending patent applications. The company has identified at least seven granted U.S. patents
that it alleges protect its COVID-19 mRNA-1273 vaccine”. 15 Although Moderna has pledged not to enforce its patents “while the pandemic
continues”, it is unclear when it will consider that the pandemic is over.16 The company has been involved in litigation over three patents held
by Arbutus Biopharma.17 Pfizer and its partner BioNTech have been sued by Allele Biotechnology and Pharmaceuticals, Inc. over the alleged
infringement of a patent on a monomeric fluorescent protein used in assays of their COVID-19 vaccine.18 The US National Institute of Health
has obtained a patent over a stabilized coronavirus spike protein that may impact the production and sale of at least 5 COVID-19 vaccines,
including Moderna’s mRNA vaccine.19 The US patent office also granted a researcher at Tel Aviv University a patent for technology that could
accelerate the development of a vaccine for COVID-19. 20 The second argument - the possible use of compulsory licenses, one of the important
TRIPS flexibilities - ignores
that issuing compulsory licenses takes time particularly if a previous negotiation
with the patent holder is needed under the applicable law. In addition, it is often difficult to identify all the patents
or other intellectual property rights covering a product or process, and patent applications are not
published for 18 months after their filing. The waiver proposal provides a more functional and appropriate
approach than individual and uncoordinated actions based on individual compulsory licenses. A waiver
would allow “uninterrupted collaboration in the development and scale-up of production and supply of health products and
technologies and collectively addresses the global challenge facing all countries”.21 In effect, compulsory licenses can only be
granted case-by-case and productby-product and the manufacture of a vaccine encompasses a large
number of components. Importantly, a compulsory license applies only to already granted patents and not
to pending applications and, unless article 31bis of the TRIPS Agreement (as incorporated in 2017) is applied with its cumbersome
requirements,22 a compulsory license can only be issued to predominantly supply the domestic market. 23
Further, in some jurisdictions the decision to grant a compulsory license may be appealed and its
implementation suspended until a final decision is made. Finally, given the territorial character of patents, there
would be a need to sim- ultaneously obtain compulsory licenses in several jurisdictions in order to put in
place an efficient supply chain. The third argument - negative impact on innovation - is particularly weak in the context of the
COVID-19 emergency as there is no market failure that inhibits return from innovation, the basic economic justification
for the grant of intellectual property rights. The demand is huge - as the vaccines need to reach at least all the world
adult population - and governments as well as COVAX are competing against each other to secure the
supply of vaccines. In addition, the Western companies now supplying vaccines have received massive
subsidies from governments. Thus, Moderna received nearly 1 US$ billion of taxpayers’ money to develop and
produce the COVID-19 vaccine,24 Pfizer/BioNTech received US$ 445 million from the German government.25 Overall, the
COVID-19 producers may have received around £6.5bn from governments while not-for-profit organizations
have provided nearly £1.5bn.26 Public financing also reduced the risk of failure, as exemplified by the failed
Merck/IAVI vaccine backed by the US Biomedical Advanced Research and Development Authority (BARDA).27 The fourth argument alludes to
the need to obtain know-how, data, etc. to initiate the production of vaccines. This is correct, but access
to these inputs may be
impeded or limited rather than facilitated by the enforcement of intellectual property rights. In addition, there are
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many manufacturers in developed and developing countries28 that may produce COVID-19 vaccines, in some cases
by repurposing plants used for the production of other biologicals. Access to know-how and data would allow
them to move fast, but acquiring the needed skills would not be otherwise impossible if scientific and industrial
support is available for the different phases of manufacturing (active ingredient, formulation, fill and finish). Much is needed to be done to
achieve a stage in which vaccines and other products to face a pandemic are truly treated as global public goods. This will require a reform of
the current research and development (R&D) model essentially based now on the appropriation through intellectual property rights of the
outcomes of innovation. From a long-term perspective, such a paradigmatic change will also ask for a reinterpretation or revision of the TRIPS
Agreement in order to allow, for instance, for a broader exception to patent rights for the export of pharmaceutical products.
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Developed nations don’t have enough stockpiles or manufacturing capacity to
vaccinate developing countries themselves
Hotez and Narayan 21 [Peter J. Hotez, Peter Jay Hotez, Dean for the National School of Tropical
Medicine at the Baylor College of Medicine with a MD and PhD, and K. M. Venkat Narayan, Professor of
Global Health and Epidemiology at Emory University and member of the National Academy of Sciences,
05-28-2021, “Restoring Vaccine Diplomacy,” Jama Network,
https://jamanetwork.com/journals/jama/fullarticle/2780640]/Kankee
More than 60 years ago, the US and the USSR, while in the midst of the Cold War, collaborated to produce and scale a new oral polio vaccine
and test it on millions of Soviet schoolchildren. The 3 poliovirus strains suitable for vaccine production were first developed in the laboratory of
Albert Sabin and were sent (with US government approval) to the USSR, where Sabin then worked with Soviet science counterparts, including
Mikhail Chumakov. These studies paved the way for the Global Polio Eradication Initiative. Later, in the 1960s, the USSR refined a technique for
freeze-drying the smallpox vaccine, making it possible to deliver it intact to remote tropical areas. This innovation helped D.A. Henderson, a US
epidemiologist, to lead a global smallpox eradication campaign under the auspices of the World Health Organization (WHO). In both cases, 2
political enemies put aside their differences to collaborate on solving great public health or pandemic threats.1 Both achievements helped to
ignite a modern international framework of vaccine diplomacy for promoting scientific collaboration for vaccine development and ensuring
vaccine equity. Global politics have clearly shifted since the time of Sabin and Chumakov, and the multipolar interconnected world of today is
far more complex than ever before. However, the principles of vaccine diplomacy remain intact, as evidenced by the establishment of COVAX,
an innovative sharing instrument led by the WHO, the United Nations Children’s Fund, Gavi, and the Coalition for Epidemic Preparedness
Innovations, focused on COVID-19 vaccine manufacture and equitable and fair distribution, especially for resource-poor settings. However,
vaccine diplomacy is now under threat by a new vaccine nationalism, in which Russia and China previously
conducted unilateral negotiations to promote their vaccines. Although there is welcomed recent news of WHO
emergency approval for the Sinopharm Chinese COVID-19 vaccine, this is not yet the case for the others. Russia has reportedly launched
clandestine efforts to disparage vaccines made in the US and Europe to promote its own Sputnik V vaccine.2
Tragically, this is happening at a time when COVID-19 is surging globally and potentially breaking new records for the
number of new daily cases, while overwhelming already underresourced communities and health systems.
Therefore, restoring or redesigning vaccine diplomacy in the coming years will require commitment to a large-scale
global effort. The 3 top priorities in this global effort are explained below. Provide Vaccines and Produce Them Locally Although the
COVAX Facility was well-considered to ensure global equity for COVID-19 vaccines once they were produced, the reality
is that an adequate supply of vaccines is simply not available. According to the Duke University Global
Health Innovation Center, under the current scenario, many low-income nations may have to wait until 2023 or
even 2024 to receive sufficient vaccine supply.3 The mRNA, adenovirus-vectored, and protein nanoparticle vaccines from
multinational companies are highly innovative in their designs and are proving to be safe and to have high effectiveness in reducing COVID-19–
related deaths and hospitalizations. However, similar to any new technology, the barriers to produce these vaccines at massive scale and
affordable cost at the outset are high. With the mRNA vaccines, onerous freezer-chain requirements represent additional logistical challenges.
So far, just
enough vaccines are being made available for the US, the UK, and Europe, mostly leaving out
low-income countries.4 More than 1 billion people live in sub-Saharan Africa, 650 million people live in
Latin America, and several hundred million people live in impoverished Asian nations. At 2 doses per
vaccine, an estimated 4 billion to 5 billion doses of COVID-19 vaccines will be needed to reduce
hospitalizations and deaths and ultimately decrease transmission in and from these areas. Yet, except for a few
wealthier nations, many African and Latin American countries are almost totally devoid of vaccines. Although
India has substantial vaccine development and manufacturing capacity, and has embarked on the vision to be the world’s leading vaccine
supplier, its March 2021 announcement to suspend its COVID-19 vaccine exports to meet the country’s own rising internal
demands5 (if not rescinded) will worsen the already dire global supply and vaccine divide. True vaccine diplomacy
requires that the US, UK, and European nations equitably share their vaccine stocks through COVAX, but even
this approach will not be sufficient. For example, even if the US releases all of its unused COVID-19 vaccines,
it would only provide a small fraction of the billions of doses required. Therefore, in the near-term, the Biden
administration must look into mechanisms to fill those gaps by supporting the production and scale-up
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manufacturing of COVID-19 vaccines. Although this is not the exclusive responsibility of the US, the nation has the greatest means
for embarking on global COVID-19 vaccine demands.
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Squo vaccine charity reinforces colonialism by causing dependence on developed
countries and won’t stop the pandemic – charity only further legitimatizes structural
violence in the Global South
Harman et al. 21 [Sophie Harman, Professor of International Politics at the University of London,
Parsa Erfani, Fogarty Global Health Fellow at the University of Global Health Equity and a medical
student at Harvard Medical School, Tinashe Goronga, medical doctor and co-founder of the Centre for
Health Equity Zimbabwe and a National Specialist at the United Nations Development Programme
Inclusive Governance Initiative, Jason Hickel, Leverhulme Early Career Fellow at the Department of
Anthropology, Michelle Morse, Instructor in Medicine and Department of Global Health and Social
Medicine Affiliate, Harvard Medical School, a Hospitalist at Brigham and Women's Hospital, and
founding director of EqualHealth, Eugene T. Richardson, Assistant Professor of Global Health and Social
Medicine, Harvard Medical School Assistant Professor of Medicine, Brigham and Women's Hospital, 0729-2021, “Global vaccine equity demands reparative justice — not charity,” London School of
Economics, https://blogs.lse.ac.uk/covid19/2021/07/29/global-vaccine-equity-demands-reparativejustice-not-charity/]/Kankee
Three limited ‘solutions’ to vaccine inequity There are currently three approaches to reduce inequity in COVID-19 vaccine distribution: bilateral
charity, multilateral charity and temporary waivers or suspensions of IP. The first is the most straightforward. States
that stockpile
COVID-19 vaccines have committed to sharing their leftovers with low-income and middle-income countries.
Norway was one of the first nations to accede to donating doses to poorer countries in parallel with its vaccine programme. This is the weakest
form of equity as it
is unclear if this will be done for free, at a lower cost, tied to diplomacy or conditionality,
or crucially, when these vaccines will be made available, where they will go, or how many will be delivered.
The bilateral charity approach has little to do with equity and more to do with geopolitics, wealth and aid
dependency. The second is multilateral charity, best exemplified by COVAX. In 2020, COVAX emerged as an international collaboration by
the World Health Organisation (WHO), United Nations Children’s Fund, Gavi and the Coalition for Epidemic Preparedness Innovations to ensure
equitable global access to COVID-19 vaccines. Rich countries can access doses for 10%–50% of their populations, depending on how much they
have paid in, and poor countries can access doses for 20% through the scheme. It is the 20% for poor countries that has come to be COVAX’s
unique selling point: here is a mechanism that ensures every country in the world can get the vaccine regardless of ability to pay. This is the first
time such an initiative has been trialled. The
shortcomings of COVAX are numerous. If vaccines are delivered as
planned, COVAX may reach 27% of the population in lower-income countries by the end of 2021—a
depressing goal compared with the estimated 70% coverage needed for herd immunity and the open
vaccine access currently granted to Americans. Furthermore, COVAX is still significantly underfunded and
there are concerns regarding supply chains. While capital and resource transfer from wealthy countries to poorer ones is surely
needed in the current pandemic response, any system that solely relies on aid will ultimately fail to achieve equity. In
the setting of vaccine scarcity, in which suppliers are unable to deliver doses as scheduled and countries are
banning exports to keep vaccines at home, there is a risk that COVAX aid-recipient states will fall further
down the priority list, awaiting the leftover vaccines from the rich country stockpiles. What may be most
pernicious about the COVAX scheme, however, is that rich countries and their pharmaceutical companies have repeatedly used it as a
shield to deflect demands for IP waivers. This is an enduring problem with aid: it papers over and distracts our
attention away from the underlying structural violence. And in so doing, it maintains and perpetuates
inequalities. Over 50 years ago, Kwame Nkrumah observed how aid is a ‘revolving credit’ which returns to countries of
the global North in the form of increased profits. To the extent that COVAX is being leveraged to protect
corporate patents and profits, Nkrumah’s words continue to be germane. The third approach is focused on pooling, temporary
waivers, or suspension of IP. In May 2020, the WHO created the COVID-19 Technology Access Pool for companies to share IP and transfer
technologies in a coordinated manner. But to date, not a single company has utilised the transfer process—likely because such forms of global
IP sharing would quell profits, even if royalties are included. Pharmaceutical companies and universities prefer one-off transfer deals because it
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enables them to set their own terms with non-disclosure agreements. Given that they are accountable to shareholders and boards—not
patients—financial incentives will drive transfer decisions, not public health demand. Following the blockages at the WHO around IP, attention
shifted towards the World Trade Organisation (WTO). In October 2020, India
and South Africa proposed a temporary waiver
of IP rights to COVID-19 technologies for the duration of the pandemic, so that all manufacturers with sufficient capacity and shared knowhow could start production. Although backed by over 100 countries within the WTO and a global campaign for the
‘People’s Vaccine,’ the proposal has been repeatedly blocked at every committee meeting since then by select wealthy
countries with large pharmaceutical industries, including the UK, Japan and EU states. Those who oppose the IP waiver argue that it will not do
anything to solve the problem: even if you were to liberate the recipe for the vaccines, low-income and middle-income countries do not have
the capacity to produce it. But this argument is specious. For one, several middle-income countries—including
India, Brazil,
Senegal and South Africa—do have the ability to ramp up production by repurposing existing
manufacturing capacity. In addition, an IP waiver can and should be supplemented with technology transfers,
logistical support and financial investment to facilitate this repurposing process. And the most important point is
that such a waiver could drastically reduce costs across the board, making vaccine imports more
affordable for poor countries. Opponents of the waiver also claim that IP-related obstacles can be addressed
through existing arrangements for ‘compulsory licensing’ under the WTO’s Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS). But the past evidence suggests that this process is slow, cumbersome and subject to
various shaming practices by the international community. Some point instead to the possibility of voluntary licensing.
But voluntary licenses are often executed secretly and are limited to companies or governments that can
afford them. The University of Pennsylvania, which owns IP rights relating to the mRNA vaccines, is helping Chulalongkorn University in
Bangkok develop a vaccine production facility. This partnership was possible because Thailand—unlike other middle-income countries—was
able to put up the money. Poorer countries are
left out. Sharing of IP and technology transfers can and will accelerate
global vaccine production. The question is on whose terms. Organisations such as the WHO and African Union are currently mobilising
support and resources to accelerate production in low-income and middle-income countries. But these efforts will be to waste unless IP for
COVID-19 technologies is shared broadly and quickly. Vaccine coloniality Donor-based
approaches to vaccine equity are
grounded in old, even colonial ideas of aid and dependency, which have failed to serve the health needs of
the Majority World or deliver on health equity. This failed model has not promoted health equity in the past
and is clearly inadequate in the present, on account of dependency on donor whims (the bilateral ‘leftovers’
approach), persistent funding gaps and shortfalls (COVAX), and time-consuming diplomacy and filibustering
over what is or is it not within current trade rules (WTO). Vaccine apartheid is only one symptom of broader global
health inequalities that have their roots in colonialism Once again in the political economy of global health, the
charitable model of COVAX becomes the smokescreen for inequitable systems. When states are asked
about their stockpiling, they point to COVAX. When pharmaceutical companies are asked about IP, they point to
COVAX or their low-cost commitment. The focus on a donor-based model of aid in achieving vaccine equity has
distracted leaders from the ideologies, economic systems and trade regulations that leave access to medicine to
the forces of the marketplace rather than global health priorities. Achieving global vaccine justice requires a
rapid shift in trade regulations and contract transparency that streamlines IP sharing and technology transfers. The
resultant collaborations across economies will not only accelerate vaccine production but will also increase
competition and push vaccine prices down. Finally, old models of vaccine equity have not kept pace with changes in discourse
and thinking around global health governance, equity and justice. 2021 is not the early 2000s, where new public–private partnerships or
funding models were de rigueur. Donor countries are increasingly wary of aid dependency as they pay the cost of continuing high profile health
programmes with diminishing strategic returns. Aid-recipient
countries are similarly exasperated by funding gaps that
lead to delays and materiel shortfalls, the NGO-industrial complex and attendant consultants that
rationalise them, and fundamentally, by the notion that their populations only seem to matter when another
state can capitalise on them. Conclusion Vaccine apartheid is only one symptom of broader global health inequalities that have their
roots in colonialism and persist today because of neocolonial forms of power. As Grosfoguel writes, ‘The heterogeneous and multiple global
structures put in place over a period of 450 years did not evaporate with the juridical–political decolonisation of the periphery over the past 50
years. We continue to live under the same ‘colonial power matrix.’ With juridical–political decolonisation we moved from a period of ‘global
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colonialism’ to the current period of ‘global coloniality.’ Vaccine
justice starts with moving beyond aid models of
vaccine donation, in which poorer countries are gifted vaccine leftovers. It demands rapidly achieving
global consensus for the IP waiver, democratising vaccine IP and know-how and supporting low-income
and middle-income countries to build manufacturing capacity for this pandemic and the next. These steps can
mark the start of a reparative justice movement in global health that demands we confront and overturn colonial
legacies that continue to devastate the health of low- and middle-income countries. A commitment to funding vaccine justice in the face of the
COVID-19 pandemic can be a first step in this direction.
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Covax/vaccine charity can’t stop the pandemic
Omar 21 [Suhail Omar, campaign lead at People's Vaccine Kenya based in Nairobi, 07-30-2021,
“COVAX isn't Africa's silver bullet,” IPS, https://www.ips-journal.eu/topics/democracy-andsociety/vaccine-colonialism-5336/]/Kankee
At the onset of the Covid-19 pandemic, politicians across the world spoke about solidarity and called the virus the great equaliser. Now, with a
solution in sight to end the pandemic – the vaccine – seems to remain a mere slogan. That’s because the Covid-19 Vaccine Global Access Facility
(COVAX) – often praised as the light at the end of the tunnel – has turned
out to be a nightmare for the developing
world. A brainchild of the Vaccine Alliance Gavi, the World Health Organisation (WHO) and Coalition for Epidemic Preparedness Innovations
(CEPI), COVAX is a global initiative aimed at creating global equitable access to the COVID-19 vaccine. Sadly, COVAX is not living up to
its promise. The facility’s opaque nature of secret agreements with vaccine manufacturers ruled out
transparency and reduced public trust. It also ignored growing concerns for accountability, as it remained
unclear who COVAX – as an unelected body – reports to and who holds it accountable. COVAX has
acknowledged issues with severe underfunding and vaccine hoarding hampering the implementation of its goals. The facility has so far shipped
over 138 million vaccines to 136 participating countries. This includes high income countries like Canada that are underway to vaccinate their
entire populations, while Africa is struggling to vaccinate priority groups – including healthcare workers. Of the over 3.79 billion vaccines
administered worldwide, COVAX is only responsible for about 3.8 per cent of total inoculations. The rich outbidding
the poor From the start, COVAX’s intended rollout was divided into two groups: high income countries (HIC) self-sponsoring the vaccines and
lower income countries (LIC) having their vaccines financed through aid. However, COVAX’s
strategy ultimately led to the
entrenchment of inequal global vaccine access. Apart of the COVAX supply infrastructure, HICs had already entered
into numerous bilateral agreements with individual vaccine manufacturers, giving them a head-start in
vaccine procurement. African governments, on the other hand, knew that they did not have enough bargaining power in the race for
vaccines. COVAX gave us the assurance that we would be provided for. But its ambition to be an equal treatment and access pool was slowly
fading as a key director of the facility broke its doctrine for global equal treatment. The CEO of Gavi shared a
statement about the possibility of choice for self-financing countries. Through the Optional Purchase Agreement, participants could choose to
pick their vaccine of choice subject to supply availability. Furthermore, the trade-off based on preference for HIC participants would not
jeopardise their ability to receive their full share of vaccines. Therefore, depending
on efficacy levels, self-financing
countries could access vaccines based on preference, leaving LIC with no choice but to take what is left
over. To further ensure safety nets for HICs. COVAX increased the access ceiling for self-financing countries. This
meant that HICs could access more vaccines than they had initially agreed with the facility. While lowincome countries were only allowed to receive vaccines that amounted to inoculating 20 per cent of
their populations, self-sponsoring countries had an increased access ceiling of up to 50 per cent of their
total populations. Vaccine apartheid As of July 2021 COVAX is still facing major procurement and supply issues,
especially since India’s ‘vaccine factory of the world’ fell short due to export controls amidst its fatal third wave. The Serum
Institute of India had been the ‘lifeline’ of the COVAX facility. Visibly, rich nations have abandoned the very
countries they claimed they stood in solidarity with. While in reality, some of the vaccines – such as Oxford’s
AstraZeneca – were tried and tested in countries like Kenya, the fully vaccinated population there remains at 1.2
per cent. COVAX’s continued paternalism and colonial mindset is an ever-present reminder that ‘aid is
dead’. Amidst vaccine nationalism by rich countries and what the People’s Vaccine Alliance – a global coalition of
organisations and activists demanding the realisation of a free and accessible Covid-19 vaccine – have called ‘vaccine apartheid’, the
Global North still holds countries labelled as ‘third world’ at the mercy of donations and occasional
performances of white saviourism, all the while ignoring the root causes. There must be an access for all According to
COVAX, the major obstacle for global vaccine access in Africa are supply constraints. But this is not the case. ‘Manufactured’ barriers,
such as the denial to waive patent rights on vaccines, are intentionally prolonging the pandemic. Africa’s
AIDS epidemic taught us that charity is not a public health plan. The refusal to back the waiver on Trade-Related
Aspects of Intellectual property (TRIPS) – supported by the World Health Organization – is plain insistence on
colonial gatekeeping of Big Pharma’s supply chains and profits. Arguably, the TRIPS waiver could’ve been cheaper and
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less risky compared to the architecture of the COVAX facility, allowing African states to control their own
destinies in vaccinating their populations. As of July 2021, African countries such as Kenya have set up budgetary
allocations for the vaccine roll-out. However, they can’t access vaccines as rich countries purchased them all and
are still hoarding them in large quantities, waiting to send them out – close to expiry – to ‘third world’
countries. Using aid as a boost to a state’s public image obscures the fact that there is no feasible way to
deliver and inoculate the intended populations any time soon. Instead, it just allows Western countries to
absolve blame and deflect the shortcomings on the African countries. At the same time, other Global South countries
like Cuba lead by example, with its recently developed ‘Abdala’ vaccine. The country is working on making its vaccine technologies more
accessible to other states. It is no secret ‘there are companies in the Global South that are able to produce vaccines, but no one is giving them a
chance,’ says global health consultant Mohga Kamal Yanni. With COVAX’s failures now visible, African
states must insist on their
right to manufacture and possibly develop – not just ‘fill and finish’ – vaccines. This also calls for radical policy change that combats
the barriers of critical sharing of medical technologies at the global level. Moreover, African states must actively work on realising the
ratification of the Abuja declaration, a pledge made by African Union countries in 2001 to spend ‘at least 15% of [the] annual budget to improve
the health sector’. Only by ensuring the allocation of more funding can the already weakened health infrastructures on the continent be
strengthened to respond to future pandemics.
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Absent domestic capabilities, wealthy nations will coerce developing countries with
vaccines with conditions to enhance their foreign policy goals
Simon Frankel Pratt, lecturer in the School of Sociology, Politics, and International Studies at the
University of Bristol, and Jamie Levin, assistant professor of political science at St. Francis Xavier
University in Canada, 0-29-2021, “Vaccines Will Shape the New Geopolitical Order,” Foreign Policy,
foreignpolicy.com/2021/04/29/vaccine-geopolitics-diplomacy-israel-russia-china/]/Kankee
The pandemic has vastly exacerbated the global north-south divide, with wealthy Western states moving steadily toward herd immunity while a
majority of Africa, Asia, and Latin America wait for vaccines to trickle down. Only
a small number of countries produce their
own coronavirus vaccines, but the rest of the world depends on them for their immunizations. This
raises the specter of a new geopolitical arrangement—one in which patron-client relationships are
determined by the asymmetry in vaccine supply versus demand. Already, there are strong indications that vaccine
have-nots are vulnerable to diplomatic coercion and enticement. Russia and China have begun
supplying vaccines in exchange for favorable foreign-policy concessions, as has Israel. Western countries,
meanwhile, are focused on their own domestic vaccination programs—although the United States has recently declared its intention to offer
vaccine aid to hard-hit countries, especially India. For the non-vaccine producers, there’s always the market—and at first glance, that has
worked out for some. The European Union has begun to round the corner, administering millions of doses among its 27 member states. Israel
continues to be an early success story; rather than employing its own considerable pharmaceutical base, it has imported millions of PfizerBioNTech doses and administered them rapidly and efficiently. And, despite having no domestic production capacity, Canada is now third for
vaccination rates for the top 34 largest countries, behind the United Kingdom and the United States. Its tens of millions of doses have all been
imported from Europe and the United States. Similar success stories can be found in Qatar, the United Arab Emirates, and Bahrain. However,
these market
success stories are largely confined to preexisting and intense trade relationships between
wealthy and advanced industrial economies. Rates of vaccinations in most other countries continue to be
very low, and notwithstanding the U.S. pile of AstraZeneca doses, this is a result of supply limits. Intellectual property
laws and infrastructure constraints mean a near-total monopolization of production capacities in a small handful
of countries and a hierarchy of trade advantages and preferences in which a handful of non-producing
countries receive priority while others are left wanting. To overcome these challenges, the World Health Organization set up
COVAX, an initiative to coordinate vaccine research and license production in order to guarantee fair and equitable distribution worldwide.
To date, however, these efforts have fallen desperately short. Few vaccines have been distributed through this
collaborative effort. Instead, facing domestic shortages, the EU and the United States have imposed restrictions on
vaccine exports, limiting supply. But while the United States, Canada, and Europe are still focusing on their own domestic
vaccination drives, other vaccine producers are willing to exploit global demand and use their own supplies as
a diplomatic instrument. China and Russia have both actively engaged in vaccine diplomacy, linking
vaccine exports to policy concessions and favorable geopolitical reconfigurations. In February, Russia
brokered the release of an Israeli citizen held in Syria in exchange for Israel financing Sputnik V vaccines to
be sent to Syria. Russia has similarly supplied vaccines to Central and Eastern European countries, drawing
them closer to its orbit. China has declared that its Sinovac and Sinopharm vaccines are a “global public good” and
has begun supplying them to nearly 100 countries, in many cases at no cost. Some of this seems intended to rapidly
undercut and abort deals that states have made with Pfizer through earlier shipments and, potentially, bribery of local officials. Meanwhile,
new leaks indicate that China
demanded changes to Paraguay’s position on Taiwan and successfully pressured
Brazil to open its 5G market to Huawei as preconditions for receiving vaccine shipments. If this is a seize-themoment, one-time thing, then Russia and China will likely come out ahead. India, too, once it has confronted the rapidly
escalating second wave. If boosters or regular vaccinations are not needed more than once every several years, then the world is unlikely to see
a significant geopolitical reorientation. But if a yearly shot is needed, as leading epidemiologists have warned may be necessary, it could be
another story. One
of the main hegemonic goods that aspiring powers provide is national security.
Geopolitical dependencies have typically manifested from the provision of military instruments through arms deals,
bases, and collective security commitments. During the Cold War, for example, vast quantities of weapons,
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training, and troops flowed into the global south as the United States and the Soviet Union competed
for client states and as those client states opportunistically sought the most generous patron. While these flows have since diminished,
they do still continue. In the current market for this good, the United States sits at the top, supported by a few allies. Russia dominates within a
small region of satellites, and China seeks the same, with mixed success but obvious aspirations. In the global pharmaceutical market, things
look different. While still a major player, the United States faces stiff competition from several potential rivals. In Western Europe, Germany
and the U.K. enjoy disproportionate influence, as does Russia in its former spheres of influence, Central and Eastern Europe. China and India
both have massive production capacity and, most importantly, dominate export markets for generics outside the West. And, despite being a
relatively small regional power, Israel also has vastly more significance than its size would indicate as another leading supplier of generics. If
demand for vaccines remains high in the long term, competition among these states to become the
world’s dominant suppliers will result in a very different global balance of power from today’s. While home to
vaccines produced by the likes of Pfizer, Moderna, AstraZeneca, and Johnson & Johnson—all now household names and whose vaccines are
considered more efficacious—governments of these states have
demonstrated a reluctance to supply doses to much
of the rest of the world at the expense of domestic vaccination rates. The United States and the U.K. have exported
almost none, and the EU is clamping down. They have similarly been unwilling to waive patents, allowing for
production of these vaccines where they are most needed. This suggests that the United States and the EU are slow to
fully exploit the geopolitical opportunities of vaccine diplomacy or at least are not willing to do so with the same alacrity and enthusiasm as
other states. That may change as time goes on, however, and the result will be worsened inequities within already inequitable trade
relationships between these countries and the global south. When it comes to Asia, the focus may be mostly on
Taiwan, where
pandemic diplomacy has been particularly intense. China has attempted to exploit the pandemic to isolate the island,
and Taiwan has moved to thwart those attempts through its own diplomatic initiatives—including
promoting its coronavirus successes. In particular, China unsuccessfully sought to link vaccine provision to cooler
relations with Taipei, in the case of Paraguay. Instead, India stepped in to provide vaccines—at the request of Taiwan. While China
might repeat such moves in the future, India’s influence will rise if vaccine provision becomes an essential and long-term geopolitical good. It
also shows that Taiwan is not without powerful patrons and that the ongoing regional competition between China and India may offer
protection. But perhaps surprisingly, the greatest beneficiary may be Israel. Teva Pharmaceuticals, the world’s single-largest producer of
generic drugs, is already poised to begin manufacturing licensed doses of the vaccines. Headquartered in the Israeli city of Petah Tikva, the
company may not be the dominant supplier for the rich markets of Europe and the United States, but it is an essential source of affordable
medicine for much of the global south and would massively boost Israel’s geopolitical influence as well should ongoing SARS-CoV-2 vaccine
provision become essential to the world’s health. Israel has reportedly offered doses to Honduras, the Czech Republic, and Guatemala in
exchange for moving their embassies to Jerusalem. The global north has begun to crawl out of the crisis with the machinery needed to provide
boosters as necessary—while the global south continues to battle an increasingly ferocious plague. Nevertheless, the pandemic may prove
geopolitically costly even for these wealthy countries as former allies or clients realign with current adversaries and as previous partners rise in
power and assertiveness.
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Government money for Covid vaccines means companies still innovate
Lindsey 21 [Brink Lindsey, vice president for research at the Cato Institute, 6-3-2021, "Why intellectual
property and pandemics don’t mix," Brookings, https://www.brookings.edu/blog/upfront/2021/06/03/why-intellectual-property-and-pandemics-dont-mix/]/Kankee
THE NATURE OF THE PATENT BARGAIN When we take the longer view, we can see a fundamental mismatch between the policy design of
intellectual property protection and the policy requirements of effective pandemic response. Although patent law, properly restrained,
constitutes one important element of a well-designed national innovation system, the way it goes about encouraging technological progress is
singularly ill-suited to the emergency conditions of a pandemic or other public health crisis. Securing
a TRIPS waiver for COVID-19
vaccines and treatments would thus establish a salutary precedent that, in emergencies of this kind, governments
should employ other, more direct means to incentivize the development of new drugs. Here is the basic bargain offered
by patent law: encourage the creation of useful new ideas for the long run by slowing the diffusion of useful new ideas in the short run. The
second half of the bargain, the half that imposes costs on society, comes from the temporary exclusive rights, or monopoly privileges, that a
patent holder enjoys. Under U.S. patent law, for a period of 20 years nobody else can manufacture or sell the patented product without the
permission of the patent holder. This allows the patent holder to block competitors from the market, or extract licensing fees before allowing
them to enter, and consequently charge above-market prices to its customers. Patent rights thus slow the diffusion of a new invention by
restricting output and raising prices. The imposition of these short-run costs, however, can bring net long-term benefits by sharpening the
incentives to invent new products. In the absence of patent protection, the prospect of easy imitation by later market entrants can deter
would-be innovators from incurring the up-front fixed costs of research and development. But with a guaranteed period of market exclusivity,
inventors can proceed with greater confidence that they will be able to recoup their investment. For the tradeoff between costs and benefits to
come out positive on net, patent law must strike the right balance. Exclusive rights should be valuable enough to encourage greater innovation,
but not so easily granted or extensive in scope or term that this encouragement is outweighed by output restrictions on the patented product
and discouragement of downstream innovations dependent on access to the patented technology. Unfortunately, the U.S. patent system at
present is out of balance. Over the past few decades, the expansion of patentability to include software and business methods as well as a
general relaxation of patenting requirements have led to wildly excessive growth in these temporary monopolies: the
number of
patents granted annually has skyrocketed roughly fivefold since the early 1980s. One unfortunate result has been
the rise of “non-practicing entities,” better known as patent trolls: firms that make nothing themselves but buy up patent
portfolios and monetize them through aggressive litigation. As a result, a law that is supposed to encourage
innovation has turned into a legal minefield for many would-be innovators. In the pharmaceutical industry, firms
have abused the law by piling up patents for trivial, therapeutically irrelevant “innovations” that allow them to
extend their monopolies and keep raising prices long beyond the statutorily contemplated 20 years. Patent law is creating
these unintended consequences because policymakers have been caught in an ideological fog that conflates “intellectual property” with actual
property rights over physical objects. Enveloped in that fog, they regard any attempts to put limits on patent monopolies as attacks on private
property and view ongoing expansions of patent privileges as necessary to keep innovation from grinding to a halt. In fact, patent law is a tool
of regulatory policy with the usual tradeoffs between costs and benefits; like all tools, it can be misused, and as with all tools there are some
jobs for which other tools are better suited. A well-designed patent system, in which benefits are maximized and costs kept to a minimum, is
just one of various policy options that governments can employ to stimulate technological advance—including tax credits for R&D, prizes for
targeted inventions, and direct government support. PUBLIC HEALTH EMERGENCIES AND DIRECT GOVERNMENT SUPPORT For pandemics and
other public health emergencies, patents’ mix of costs and benefits is misaligned with what is needed for an effective policy response. The
basic patent
bargain, even when well struck, is to pay for more innovation down the road with slower diffusion
of innovation today. In the context of a pandemic, that bargain is a bad one and should be rejected
entirely. Here the imperative is to accelerate the diffusion of vaccines and other treatments, not slow it down.
Giving drug companies the power to hold things up by blocking competitors and raising prices pushes in
the completely wrong direction. What approach to encouraging innovation should we take instead? How do we incentivize drug makers
to undertake the hefty R&D costs to develop new vaccines without giving them exclusive rights over their production and sale? The most
effective approach during a public health crisis is direct government support: public funding of R&D, advance
purchase commitments by the government to buy large numbers of doses at set prices, and other, related payouts. And when we pay drug
makers, we should not hesitate to pay generously, even extravagantly: we want to offer drug companies big profits so that they prioritize this
work above everything else, and so that they are ready and eager to come to the rescue again the next time there’s a crisis. It
was direct
support via Operation Warp Speed that made possible the astonishingly rapid development of COVID-19
vaccines and then facilitated a relatively rapid rollout of vaccine distribution (relative, that is, to most of the rest of the world). And it’s worth
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noting that a major reason for the faster rollout here and in the United Kingdom compared to the European Union was the latter’s misguided
penny-pinching. The EU bargained hard with firms to keep vaccine prices low, and as a result their citizens ended up in the back of the queue as
various supply line kinks were being ironed out. This is particularly ironic since the Pfizer-BioNTech vaccine was developed in Germany. As this
fact underscores, the chief advantage of direct support isn’t to “get tough” with drug firms and keep a lid on their profits. Instead, it is to
accelerate the end of the public health emergency by making sure drug makers profit handsomely from doing the right thing. Patent law and
direct support should be seen not as either-or alternatives but as complements that apply different incentives to different circumstances and
time horizons. Patent law provides a decentralized system for encouraging innovation. The government doesn’t presume to tell the industry
which new drugs are needed; it simply incentivizes the development of whatever new drugs that pharmaceutical firms can come up with by
offering them a temporary monopoly. It is important to note that patent law’s incentives offer no commercial guarantees. Yes, you can block
other competitors for a number of years, but that still doesn’t ensure enough consumer demand for the new product to make it profitable.
DIRECT SUPPORT MAKES PATENTS REDUNDANT The situation is different in a pandemic. Here the government
knows exactly what it wants to incentivize: the creation of vaccines to prevent the spread of a specific virus
and other drugs to treat that virus. Under these circumstances, the decentralized approach isn’t good enough. There is no time to sit
back and let drug makers take the initiative on their own timeline. Instead, the government needs to be more
involved to incentivize specific innovations now. As recompense for letting it call the shots (pardon the pun), the
government sweetens the deal for drug companies by insulating them from commercial risk. If
pharmaceutical firms develop effective vaccines and therapies, the government will buy large, predetermined quantities at prices set high
enough to guarantee a healthy return. For the pharmaceutical industry, it is useful to conceive of patent law as the default regime for
innovation promotion. It improves pharmaceutical companies’ incentives to develop new drugs while leaving them free to decide which new
drugs to pursue – and also leaving them to bear all commercial risk. In a pandemic or other emergency, however, it is appropriate to shift to the
direct support regime, in which the government focuses efforts on one disease. In this regime, it is important to note, the government provides
qualitatively superior incentives to those offered under patent law. Not only does it offer public funding to cover the up-front costs of drug
development, but it also provides advance purchase commitments that guarantee a healthy return. It should therefore be clear that the
pharmaceutical industry has no legitimate basis for objecting to a TRIPS waiver. Since, because of the
public health crisis, drug makers now qualify for the superior benefits of direct government support, they
no longer need the default benefits of patent support. Arguments that a TRIPS waiver would deprive drug
makers of the incentives they need to keep developing new drugs, when they are presently receiving the most
favorable incentives available, can be dismissed as the worst sort of special pleading. That said, it is a serious
mistake to try to cast the current crisis as a morality play in which drug makers wear the black hats and the choice at hand is between private
profits and public health. We would have no chance of beating this virus without the formidable organizational capabilities of the
pharmaceutical industry, and providing the appropriate incentives is essential to ensure that the industry plays its necessary and vital role. It is
misguided to lament that private companies are profiting in the current crisis: those profits are a drop in the bucket compared to the staggering
cost of this pandemic in lives and economic damage.
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Developing countries have the tech and know-how from existing facilities and it’s the
norm for other companies to help out
Kavanagh and Sunder 21 [Matthew Kavanagh, director of the Global Health Policy & Politics
Initiative at Georgetown University’s O’Neill Institute for National and Global Health Law and assistant
professor of international health, and Madhavi Sunder, associate dean for International and Graduate
Programs and law professor at Georgetown University Law Center, 03-10-2021, "Opinion: Poor countries
may not be vaccinated until 2024. Here’s how to prevent that.," Washington Post,
https://www.washingtonpost.com/opinions/2021/03/10/dont-let-intellectual-property-rights-get-wayglobal-vaccination/]/Kankee
Two decades ago, in
the midst of the AIDS crisis, the WTO’s Doha Declaration affirmed intellectual property rules
“should not prevent members from taking measures to protect public health.” But the clarification of the
right of nations to issue compulsory licenses and make generic medicines came too late: More than 5 million people
in low- and middle-income countries died from AIDS waiting for the WTO to clarify its rules. Now we are in
the middle of another global health emergency. Two-thirds of WTO members back waiving patent rules during
the pandemic, but the United States and others argue that patents are critical for innovation and are not slowing the global supply of vaccines.
Neither is true. First, patents
played little, if any, role in stimulating the “warp speed” development of covid-19
vaccines. The Moderna vaccine was almost entirely funded by the U.S. government, with an additional $1 million
donated by Dolly Parton. It is inappropriate for a private company to monopolize technology funded by
taxpayers. Moderna itself recognizes this, having previously announced that it will not seek to enforce its vaccine patents.
The United States also argues the waiver is unnecessary because countries such as India can already begin producing covid-19 vaccines for their
own populations,, and export them to developing countries under existing
WTO rules. But the current machinery is
cumbersome; implementation may take years. The waiver, however, would allow generic drug companies to
begin making and distributing the vaccines as soon as possible. Finally, the United States and other opponents argue
that even if generic drug companies get the patents, there is nobody who can make them. They suggest technology using mRNA underlying
some of the new vaccines is so complicated that even respected generic drug companies cannot make the vaccines. This leads us to the next
necessary step: tech transfer. If
patent rights are waived, companies around the world, such as Biovac in South Africa or
rapidly retool their manufacturing capacity to make these vaccines, with experts at the
ready to help. But they also need the recipe. While a patent is supposed to explain how to make a product, many of today’s
pharmaceutical patent filers intentionally obscure this information. Therefore, the companies making these vaccines should
share exactly how they make them. Sharing technology with low- and middle-income countries is standard
practice for many medicines. Gilead Sciences shared technology to help manufacturers based in Egypt, India and Pakistan to make and sell
Cipla in India, could
remdesivir as a covid-19 treatment last year; a company co-owned by Pfizer has done the same for HIV drugs. Vaccines are harder to engineer
than AIDS drugs, so sharing tech is essential. Having
funded key vaccine development, the U.S. government has the
leverage to push companies to open up their vaccines to the world. The World Health Organization has
already said it will help with expertise, and companies such as Moderna, Pfizer and Johnson & Johnson could
receive royalties on the sales. But what they must not do is block producers in Africa, Asia and Latin America
from making lifesaving vaccines and exporting them to their neighbors. We cannot afford to repeat the mistakes of the past. Just as
the AIDS crisis in Africa necessitated the Doha Declaration, the covid-19 pandemic necessitates both a temporary
intellectual property waiver from the WTO and a bold effort to share know-how — not in 2024, but now. Indeed, the covid-19
era should change the way we think about patents and public health. Intellectual property rights are not ends in
themselves; they are tools to promote human flourishing.
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Many firms globally have the capability to make millions of extra vaccines
Lerner and Fang 21 [Sharon Lerner, Investigative Reporter at The Intercept covering health, science,
and the environment, Lee Fang, contributing writer at The Nation with a BA in government and politics
from the University of Maryland, 04-29-2021, https://theintercept.com/2021/04/29/covid-vaccinefactory-productionip/?utm_campaign=theintercept&utm_medium=social&utm_source=twitter]/Kankee
Bill Gates, the billionaire philanthropist whose foundations help manage the United States and Europe’s primary Covid-19 outreach efforts to
the developing world, known as Covax, was even more blunt. “It’s not like there’s some idle vaccine factory, with regulatory approval, that
makes magically safe vaccines,” Gates said last weekend by way of explaining to Sky News why he thought the recipe for making coronavirus
vaccine should not be shared. Except it is exactly like that. Factory
owners around the globe, from Bangladesh to
Canada, have said they stand ready to retrofit facilities and move forward with vaccine production if given the
chance. “We have this production capacity and it’s not being used,” said John Fulton, a spokesperson for Biolyse
Pharma, a company based in St. Catharines, Ontario, that produces injectable cancer treatments. Fulton noted that Biolyse has spent
years buying equipment to produce biologics and is uniquely prepared to start getting ready to produce
vaccines. The company, which Fulton said is best suited for replicating the Johnson & Johnson vaccine, could produce as many
as 20 million vaccines per year, he estimated. Abdul Muktadir, chair and managing director of Incepta, a pharmaceutical
firm based in Dhaka, Bangladesh, has told reporters that his firm has the capacity to fill vials for 600 million
to 800 million doses of vaccine per year. He has reportedly reached out to Moderna, Johnson & Johnson, and Novavax. “Now
is the time to use every single opportunity in every single corner of the world,” Muktadir told the Washington
Post. “These companies should make deals with as many countries as possible.” Other firms in South Korea
and Pakistan have also reportedly expressed an interest in producing vaccines or vaccine components. So far,
much of the pressure to share technology has centered on messenger RNA vaccines, such as those made by Pfizer-BioNTech and Moderna,
which are approved in the U.S. and highly effective against Covid-19. The mRNA model also offers the advantage of having a production process
that’s simpler than that of some other vaccines and may be quickly adapted to respond to emerging variants of the virus. But the
companies that have pioneered the mRNA vaccines have yet to offer to share their knowledge and
expertise. Earlier this month, the World Health Organization established the mRNA technology transfer hub, through which manufacturers
of medical products and owners of patented vaccine technology have been invited to provide know-how, process training, and intellectual
property rights so that low- and middle-income countries can produce their own vaccines. On Tuesday, Martin Friede, coordinator of the
WHO’s Initiative for Vaccine Research, said that the hub had already received some 50 expressions of interest from companies, including some
that have patents on components or processes involved in vaccine manufacturing. But Moderna; BioNTech, the German company that has
developed an mRNA vaccine in partnership with
Pfizer; and CureVac, another German company that has developed an mRNA vaccine with
a longer shelf life, have yet to respond to the call, according to Friede. Friede emphasized that a lack of know-how, as opposed to
patent protections, are the major barrier to expanding production. Others agree sharing know-how is key — and getting
cooperation from the companies that created the mRNA vaccines is necessary before deciding to retrofit or build
facilities to make them. “It’s useless to focus on that if BioNTech and Pfizer and Moderna are not going to surrender the information on how to
do it,” Edward Hammond, an independent consultant who works on vaccine manufacturing, said in a recent online roundtable about vaccine
production capacity. “If it is the case that we don’t have an open and cooperative and productive technology transfer environment, then the
capacity situation looks a little bit different because you’re going to be relying on a different set of technologies.” Scaling up supply to meet the
global need will also require overcoming shortages of various components, including the tiny fat droplets that enable the mRNA in the vaccine
to enter cells, which may also slow the the process of upscaling production. Gates suggested that it could be unsafe to share the critical
information that allows vaccines to be more widely produced: “There’s only so many vaccine factories in the world, and people are very serious
about the safety of vaccines. And so moving something that had never been done — moving a vaccine, say, from a [Johnson & Johnson] factory
into a factory in India — it’s novel — it’s only because of our grants and expertise that that can happen at all.” The delay in getting vaccines to
low- and middle-income countries, he added, was shorter than expected. “Typically in global health, it takes a decade between when a vaccine
comes into the rich world and when it gets to the poor countries.” Yet, in the past few months, the
danger of not transferring the
knowledge more quickly has become painfully clear, with deaths climbing in India, Brazil, and other
parts of the world that have been unable to procure adequate supplies of vaccines while richer countries
stockpile them. The inequality is only increasing. The state of Florida, which has a population of 21.5 million,
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has now received some 20 million vaccine doses — more than Covax has delivered to all of Africa, which is home to 1.2
billion people. Worldwide, Covax, which is now supplying vaccines to over 100 economies, has only delivered 49 million doses so
far, less than have been distributed in California and Illinois. Meanwhile, wealthy countries are already in the
process of purchasing booster shots. Canada just made a deal with Pfizer to get 35 million doses of
boosters by next year, which means they will arrive before most people around the world receive their first
shot.
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Developing countries aren’t antivaxxers and are more willing to get the vaccine then
Americans
Geddes 21 [Linda Geddes, author and journalist specialising in biology, medicine and technology with
a degree in Cell biology from Liverpool Unierviserty, 07-29-2021, “Willing and waiting: High levels of
COVID-19 vaccine acceptance identified in Global South,” Gavi Vaccine Alliance,
https://www.gavi.org/vaccineswork/willing-and-waiting-high-levels-covid-19-vaccine-acceptanceidentified-global-south]/Kankee
Four in five people in low- to middle-income countries are willing to get vaccinated against COVID-19 – a
significantly higher proportion than in either the United States or Russia – data suggests. The finding, published in
Nature Medicine, suggests that prioritizing vaccine distribution to the Global South should yield high returns in
terms of boosting global immunity against COVID-19. Widespread acceptance of COVID-19 vaccines is
essential to minimise deaths from the disease and hasten the end of the global pandemic. Yet, even though vaccines
have been available for more than six months, we still know relatively little about attitudes towards COVID-19 vaccination in lower-income
countries. Here, large-scale vaccination
is only just beginning, with an estimated 1% of people in low-income
countries having received at least one dose. “Understanding the drivers of COVID-19 vaccine acceptance is of global concern,
because a lag in vaccination in any country may result in the emergence and spread of new variants that
can overcome immunity conferred by vaccines and prior disease,” the authors write. To investigate, Julio S. Solís Arce at the
WZB Berlin Social Science Center in Germany and his colleagues surveyed the attitudes of 44,260 individuals
across ten low- and middle-income countries (LMICs) in Asia, Africa and South America, as well as in Russia and the United
States. They found that COVID-19 vaccine acceptance was considerably higher in the LMICs, compared to
in the United States and Russia. Here, 80.3% of people said they’d be willing to get vaccinated (median 78%),
compared to 64.6% of Americans and 30.4% of Russians, on average. These high rates of acceptance in
LMICs were primarily explained by a desire for personal protection against COVID-19, while the most commonly
cited reason for hesitancy was concern about side effects. Health workers were regarded as the most trusted sources of guidance about COVID19 vaccines. Burkina Faso and Pakistan had the lowest rates of COVID-19 vaccine acceptance among the LMICs included in the study, with an
average rate of 66.5% in both countries. In the case of Pakistan, this could be related to negative historical experiences with foreign-led
vaccination campaigns, while in Burkina Faso, it could represent general vaccine hesitancy. Here, fewer people believe that vaccines in general
are safe in than in any other of the surveyed counties, apart from Russia. The
country with the highest rates of vaccine
acceptance was Nepal, where 96.6% said they would be willing to be vaccinated against COVID-19. In general,
men were more willing to be vaccinated than women, but there were no consistently significant differences with respect to age or education.
Although the researchers cautioned that their data may not be representative of all LMICs, and that some individual samples may not be
nationally representative, they said their main
finding of greater acceptance in LMICs compared to the US or Russia
was consistent across all of the countries they surveyed. “The high levels of vaccine acceptance we
identify suggest that prioritizing distribution to LMICs may be an efficient way to achieve immunity on a
global scale and prevent novel variants from emerging,” they added. “Vaccination campaigns should focus on
converting positive intentions into uptake, which may require investment in local supply chains and delivery. “Messages
highlighting vaccine efficacy and safety, delivered by healthcare workers, could be effective for addressing any remaining hesitancy in the
analysed LMICs.” The countries included in the survey were: Burkina Faso, Mozambique, Rwanda, Sierra Leone and Uganda (low-income
countries); India, Nepal, Nigeria and Pakistan (lower-middle-income countries); Columbia and Russia (upper-middle income countries); and the
United States (high income country).
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Contention 4: IPR Fake News
We can’t choose which ideas we choose to create – any creative thought is a
recombination or variation of previous memes an inventor holds no right to
Gunten 15 [Andreas von Gunten, philosopher with an MA in Philosophy, 2015, “Intellectual Property is
Common Property,” Philosophy Archive, https://philarchive.org/archive/VONIPI]/Kankee
THE CREATOR AS A MEME COPY MACHINE We usually think of every cultural expression as a result of one or more person’s labour. But it is
more than just ‘labour’ that we attribute as the input factor for the result of a creative process. It is a kind of extraordinary creativity, which not
every person is fortunate enough to have. For some it is even the divinity which talks to us, through the creator. Our perception of the artist is
often that of a genius. But is the creator then really a creator in the sense of being a creative agent, or is he just a means to represent and
reproduce what the ‘Zeitgeist’, God or his unconsciousness creates? Is the inventor really an inventor or is he just an explorer of what is already
there? In other words, is creativity something where we act as active agents, or is it something which just happens unconsciously inside our
neural system? In the closing chapter of his 1976 book, The Selfish Gene, Richard Dawkins introduces his postulate of the meme (Dawkins
2006).2 In 1991 Daniel Dennett used this concept as an important building block for his account of how human consciousness can be
understood from a materialist perspective (Dennett 1993). The term “meme” is an abbreviation of the ancient Greek word “mimeme” which
stands for ‘imitator’. A meme is a
cultural expression, or a behaviour which reproduces itself while jumping from
brain to brain. This happens through human imitation. Imitation is the building block of human culture and
tradition. The brain is the copy machine for the memes. Cultural evolution occurs, like biological
evolution, as soon as there is information which shows variation, selection and heredity. Memes get copied by
imitation. During this copy process they are sometimes changed only slightly, and sometimes they are
recombined with other memes, which leads to variation. Some memes are more successful in getting
copied than others, which gives us selection. For example the idea of nations and states was more successful than the idea of a
society without authorities; the idea of a person-like God was more successful than the pantheistic or animistic world views, or the story of two
lovers who are not allowed to come together and eventually commit suicide is told in different variations and settings over centuries, and so
on. The concept of the meme is important for our analysis of intellectual property because it gives us a framework to explain cultural evolution
as an interpersonal process from which we cannot postulate one individual as the exclusive creator of a creative work. Ideas
cannot
realise themselves without brains, but brains are not the creators of ideas, they are just the hosts for the
replication process. Even if an individual person recombines different memes, which is more common than the
simple copying from one meme, it is still a copying process, which we cannot really operate ourselves actively. It just happens with us,
inside our brains. As I am writing this text, I am not really in charge in the sense that I decide which memes I
am taking and combining with others. I do of course have the experience of ‘thinking myself,’ but this is not what actually
happens inside my brain according to Daniel Dennett (1991).3 Everything I write here is the result of a continuous meme
copying and recombination process. One association leads to another. The river of consciousness is full of
surprises which I cannot claim myself as an active agent to be responsible for, in the sense that I can insist on an
exclusive property right for what comes out of my brain.4 Artists also often talk about having the sense of not being in
charge while creating their artwork. They emphasise that they don’t know how it comes about that they are
creative. They usually are not aware of what is going on in their consciousness while creating a piece of art,
or at least are not able to explain it. It is common that they talk about inspiration on which they depend and that one
has to wait until it arrives. Sometimes it does not arrive at all. The idea of the need to be inspired by outside forces to be able to be
creative can be traced back to the Muses of Greek mythology. The romantic concept of art, which emphasises that the genius has the benefit to
let the divine express itself through the artist, also leads to the idea that the genius himself is not in charge here, but something else is. Human
beings and their memes are living in a symbiotic system. Cultural expressions seem to be continuously replicated inside brains, and from brain
to brain, so to speak. Each copy is slightly different from its original and is at the same time another original for the next replication procedure.
This is important because it shows that all
expressions are equal in the sense that they are all copies and originals at
the same time. We should not imagine memes as singular representations of expressions or ideas in our brain though. They are
rather complex compositions of many different aspects and attributes of them in different places and at different times
as Daniel Dennett explains in his multiple drafts model (Dennett 1991:111ff). THE CREATIVE PROCESS AS A COLLECTIVE PROCESS Because
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ideas jump from brain to brain in the form of memes the creative process has to be seen as a collective process.
Every piece of art, every patent, every musical pattern, every behaviour is always the end- and starting point of a
continuous collective process of human creativity and innovation. Ideas are represented through expressions. These can be
words, images, music melodies, behaviours and so on. There are no ideas without representation, which means that we cannot communicate
or experience ideas without them being expressed somehow. The ideaexpression relationship is far more complex and controversial than we
can discuss in this paper, but for our purpose (to point to the mechanism of cultural evolution through copying) it should be sufficient to
understand its general aspects. Every expression of a human being is the result of the recombination of what has been expressed by someone
else and of the meme copying process inside his neural system. We have evidence for the collective aspects of creativity from Ludwik Fleck’s
philosophy of science. According to Fleck it
is not correct to assume that human beings think individually. We should
accept the fact that ‘cognition is a collective process’ (Sady 2012). ‘A truly isolated investigator is impossible… An isolated
investigator without bias and tradition, without forces of mental society acting upon him, and without the effect
of the evolution of that society, would be blind and thoughtless. Thinking is a collective activity… Its product
is a certain picture, which is visible only to anybody who takes part in this social activity, or a thought which is also clear to the members of the
collective only. What
we do think and how we do see depends on the thought-collective to which we
belong.’ (Fleck 1935b, cited in Sady 2012) Fleck is stressing here that without mental content from other members of the
thoughtcollective we belong to, we would not be able to give meaning to our thinking. We could also say that Fleck
describes some of the cultural effects of the meme-replication-process. This becomes even more apparent when we look at how Wojciech Sady
describes the definition of Fleck’s thought collective: ‘A
thought collective is defined by Fleck as a community of persons
mutually exchanging ideas or maintaining intellectual interaction (Fleck 1935a, II.4). Members of that collective not
only adopt certain ways of perceiving and thinking, but they also continually transform it—and this transformation does occur not so much “in
their heads” as in their interpersonal space.’ (Sady 2012) The continuous
transformation of ideas in ‘their interpersonal space’ is
what we could also call cultural evolution. And even if Fleck has provided his account in the special context of the question of how
scientific research works, we can easily adapt it to the creative process as such. Not only in science but in every aspect of creativity, cultural
evolution is at work. Let us imagine in a short thought experiment a human being born on an island, where his parents have died right after his
birth. Somehow he has managed to survive and he is living now as an adult alone on this island. It is rather unlikely that he has started to paint
images in his leisure time, but for the sake of the argument, let us assume he did. But what seems to be rather implausible is that he paints
images in the style of cubism without any social interaction or cultural heritage. Cubism is a typical example of a phenomenon of cultural
evolution and at the same time an example of how our society tends to attribute cultural innovations to individuals even if there is much
evidence that it is more an emergence of the “Zeitgeist” than a creative event by a single genius. Pablo Picasso and Georges Braque are
usually said to be the
inventors of cubism, while at the same time it is considered as a fact in art history that there were
different pre decessors and influences which prepared the ground to let the new movement arise. We can consider
the members of the cubist movement as a thought collective in Ludwik Fleck’s sense and adapt his findings to the process of art production.
Even if we consider Pablo Picasso to be one of the most important artists of cubism it does not seem very
probable that he would have created the same type of paintings had he lived in the eighteenth century or
had he been raised by a worker family in Manchester around 1850. And it also does not seem very likely that cubism would not have evolved if
Pablo Picasso had never lived at all. Nevertheless, it cannot be denied that it was Picasso who painted Les Demoiselles d’Avignon and not some
thought collective. There is at least a substantial individual part in the creative works of artists of any kind. There is no artwork without the
decision of the artist to start working on it. If he decided to plant trees instead of creating a piece of art, there would be no painting, song or
text we could enjoy and analyse. This is definitely true, but the question is, is this enough to consider him as the only source of the result and to
provide him therefore with the rights to exclusively exploit the benefits from it? It is undeniable that there lies labour in every cultural artefact,
and this labour can usually be attributed to the creators. It was Pablo Picasso who moved the paint brushes to create his Les Demoiselles
d’Avignon and not Paul Cézanne. But the
fact that this picture looks how it looks cannot be attributed to Picasso
alone. Let us assume the meme model and the thought collective are adequate conceptual descriptions for how human expressions and ideas
evolve interpersonally. It still can be said that what we call being creative is what is new or original, and that this is exactly what the individual
aspect of creativity represents. The problem here lies in the question: what is to be considered as new or original? As we have seen in the case
of cubism, even when we
can assign a new category to an artistic style, it has not evolved out of nothing. The
we
consider as radically new and original in the history of our culture, like cubism, or as another example the theory of relativity formulated
by Albert Einstein, can be traced back to former works by other individuals which were necessary foundations
for Picasso or Einstein to make their discoveries. There is never anything radically or totally new in human culture.
Every cultural expression evolves slowly from its predecessors. Evolutionary steps are very small: so small that they
borders of such categories are always blurred and arbitrary, and they fade away as soon as we try to find them. And even what
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usually are not detected. It is the last straw that breaks the camel’s back. The famous big theories, the so-called new inventions in art or the
great discoveries in science are always results of long-lasting interpersonal creative and evolutionary processes. It looks as though it is mere
luck that the memes are combined in a particular way inside a neural system from a specific individual and not through someone else’s. Of
course, the artist or the scientist has often contributed a lot of personal
education and work to bring themselves into the position to
be able to make this very last important step for a new discovery or a new kind of cultural work. But it remains a small step
compared to the whole process which was needed before he could take this step. Albert Einstein knew this as well. He said at a
meeting of the National Academy of Science in 1921: When a man after long years of searching chances on a thought which discloses
something of the beauty of this mysterious universe, he should not therefore be personally celebrated. He is already sufficiently paid by his
experience of seeking and finding. In science, moreover, the
work of the individual is so bound up with that of his
scientific predecessors and contemporaries that it appears almost as an impersonal product of his
generation. (Einstein 1921:579) The creator or author is far from being passive in this process. As we have seen above, it was Picasso who
painted his paintings and it was Einstein who wrote his papers. So there is definitely an important individual part in every cultural work. But
when we take the collective aspect of the creative process we have sketched so far into consideration, it looks like it just does not seem to be
justified to attribute the originality to the individual by whom it was expressed. The person who creates a work should not be seen as its author
or creator but more as its source. This kind of attribution gives respect to the individual part without stressing it too far. There are many
practical reasons to attribute the work to a source. It helps others to refer to it, it may help to understand it better, it may even help to give
some other kind of reward (e.g. money) to its source. But just
because we are the source of a piece of work, we cannot
thereby claim that we are the single author or creator and therefore the owner of it. Such a treatment of the work is also
in line with Kant’s account of the person ality rights of an author. While attributing the source of an expression, we esteem the individual part
one has on the creation of a cultural expression without making him the sole creator and exclusive owner. Both the postulation of a meme
theory and the concept of the thought collective may lead to several objections. The most important is that the concept of free will may not be
compatible with these views. Meme theory as proposed by Daniel Dennett has to be considered as a materialistic theory of the mind.
Materialistic theories of the mind and the concept of the thought collective can be called deterministic
in their character. It is disputed whether free will is compatible with determinism or not, and we cannot discuss this question in this
paper. And it is true that if we hold the view that free will exists and that it is not compatible with determinism we have to reject meme theory
and maybe Fleck’s thought collective as well. But we could still accept that creativity and innovation are more to be perceived as interpersonal
than individual processes; we just have to find another theory which is not in conflict with free will. Anyone
who insists on the view that
ideas and expressions are naturally owned by the individual from whom they occur, must also provide a
plausible theory as to how minds produce ideas independently from their social environment. I do not assert
that such a theory does not exist, but I have not come across one yet. But if we accept that we are merely a source rather than a creator of
cultural expressions, and if the only thing which we can take into account for intellectual property rights is the labour we have contributed and
not the creativity itself, there seems to be little ground for any personality-based account of intellectual property rights. The only hope for the
justification of the personal property of cultural expressions and inventions lies now in the utilitarian arguments, which are the ones we are
going to examine in the following chapter
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IPR’s abstract status means usage by others doesn’t harm your own property rights
Gunten 15 [Andreas von Gunten, philosopher with an MA in Philosophy, 2015, “Intellectual Property is
Common Property,” Philosophy Archive, https://philarchive.org/archive/VONIPI]/Kankee
EGALITARIAN JUSTIFICATION FOR INTELLECTUAL COMMONS A
just society from an egalitarian point of view gives individuals, in
addition to equal rights to maintain and develop a life according to their own desires, equal access to worldly resources, such that
the rules for distributing the resources equally amongst its members can overrule the personal freedom
of the individual14 . As we have seen above, intellectual property rights are monopoly rights which grant a
temporary privilege to exclusively exploit income rights from abstract objects which are created
collectively. Nevertheless there are several possible arguments to justify these rights on egalitarian grounds. First, it could be argued that
these privileges are not arbitrary. They are granted to individuals who deserve them, because they are the creators or inventors. It is not
individuals with the most money who get the monopoly rights from the state, but those who are willing to bring their ideas into existence in
form of expressions. If a privilege for creators serves the goal of getting a more equal distribution of wealth, it can be justified. A second point is
that social justice from the egalitarian point of view needs state-enforced redistribution of goods, and therefore the state needs an intellectual
property rights framework to redistribute the profits which can be raised from abstract objects. And a third argument would be that intellectual
property rights are rights which help the individual creator against exploitation by powerful corporations or other organisations. While
discussing these arguments, we should be aware that we tend to apply distribution problems from physical objects to abstract objects. And in
the world of physical objects and a private property rights-based society, we do in fact face the problems
which come with
unequal appropriation of worldly resources. An individual who has more talent may be able to appropriate resources faster
than others, so that in the end there is nothing left. Today, there is not one square foot of land on our planet which is not ‘owned’ by someone.
Whether the owner is an individual or a collective of some sort, there is always someone who claims ownership. Land
and every other
worldly resource are finite15 and therefore there is always a struggle about the question of to whom they
belong. But in the case of abstract objects, the situation is totally different. The use of abstract objects like cultural
expressions, ideas, inventions and so on is not limited simply because someone else is using them, as we have
discussed already. If I build my house on a piece of land, and someone wants to do the same on the same piece of
land, he has to send me packing. He then has the land and I don’t. If I invent a wheel and use it for my
convenience, I can share this invention without reducing its value for me. In fact any invention and any
expression can be shared by anyone without dimin ishing its utility for others. The value for me also does
not reduce if someone who has more capital at his disposal than I do is able to produce wheels to sell
them on a market. I can still use my own wheel, which I have created. There is even a chance that the producer of
the wheels innovates on it and makes it better, and as he cannot claim intellectual property rights either, I
am able to use his ideas to upgrade my wheel as well. If there is a demand for wheels, chances are high
that I will still be able to find my market for my handmade wheels, even if a lot of other ‘wheel makers’ are producing them
at lower costs. Buyers do not value only monetary aspects; a lot more is often taken into account for a buying decision. In a world with private
intellectual property rights the rights holder can exploit the income exclusively; in a world with intellectual
commons everyone has the chance to do so. From an egalitarian point of view this fact raises the problem that the more
talented and/or the more powerful may be able to exploit the profits from the cultural expressions of any
kind much more effectively than the less talented, whether this is the creator or someone else. This is partly true, but it is true in
any world, whether there exists a legal framework for intellectual monopoly rights or not. We can see this very well in the actual situation in
our world. Most of the income
from intellectual property rights is concentrated around a few big players in
every market. The main difference is that the powers are more stable in a world with intellectual property and more dynamic in a world
without. In a world without intellectual property rights, monopolies could still occur but they would be de facto monopolies, and
these types of monopolies will not last long. The abolition of intellectual property rights would lead to a more fragmented and
decentralised economic situation as no one can be prevented from copying inventions and cultural expressions. Profits will be near
zero for those who just copy and will be higher for those who innovate on the copy. Intellectual property
rights are not an effective instrument for redistribution of income or wealth. From an egalitarian point of view the
problem of inequality persists, and as intellectual property rights are monopoly rights they create even more
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inequality on one part between the “winners” and the “losers” inside the system, but also between rights holders and
users. If we consider the situation that without intellectual property rights, the use of any expression or invention is open to everyone, we can
easily see that in such a world a much more diverse market would evolve. As there are no monopoly rights, probably many more individuals
and smaller groups would use the cultural expressions which are free to use, and remix them with their own ideas to create new products and
services to make a living. With the system of intellectual property rights which we have in place now, the exploitation of the inventor or the
creator through big corporations is the reality. Only for a few ‘superstars’ might the situation be the other way around. There are two main
reasons for this. First, it is expensive to get and even more expensive to enforce intellectual property rights; and second, the big money lies in
the portfolio of rights and not in the single expression. Even if there are blockbusters which generate a multiple of the income from the average
‘product’ for the rights holders, it is usually the backlist, the sum of thousands of single products, which is the important source of a permanent
revenue stream for the big rights holders. But isn’t it the case that the creator gets at least his share from the revenue stream and without
intellectual property rights these companies could take everything for themselves without even thinking of letting the creator or inventor
participate? This is true, but for most creators the share is so small that it does not contribute to enhancing their economic situation. In many
cases they would be in a better situation to generate income with their creations if they had not exclusively sold the licences for the
exploitation of his work to a single company. From an egalitarian perspective, the most important question is: how can wealth be distributed
equally amongst the people? The intellectual property rights regime obviously does not contribute much to solving this problem; it rather looks
like it does the opposite. I do not argue here that the absence of individual intellectual property solves the general distribution problem, but it
leads to a situation where many more people can benefit from cultural expressions, scientific research and inventions than now, and therefore
less redistribution is needed.
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IP has no material basis and arbitrarily infringes on actual (property) rights – all
patents are expressions of publicly available laws of nature
Long 95 [Roderick T. Long, American professor of philosophy at Auburn University with a PhD in
philosophy from Cornell, 1995, “The Libertarian Case Against Intellectual Property Rights,” Free Nation,
http://freenation.org/a/f31l1.html]/Kankee
The Ethical Argument Ethically, property
rights of any kind have to be justified as extensions of the right of
individuals to control their own lives. Thus any alleged property rights that conflict with this moral basis —
like the "right" to own slaves — are invalidated. In my judgment, intellectual property rights also fail to pass this test. To
enforce copyright laws and the like is to prevent people from making peaceful use of the information they
possess. If you have acquired the information legitimately (say, by buying a book), then on what grounds can you be
prevented from using it, reproducing it, trading it? Is this not a violation of the freedom of speech and
press? It may be objected that the person who originated the information deserves ownership rights over it. But information is not a
concrete thing an individual can control; it is a universal, existing in other people's minds and other
people's property, and over these the originator has no legitimate sovereignty. You cannot own
information without owning other people. Suppose I write a poem, and you read it and memorize it. By
memorizing it, you have in effect created a "software" duplicate of the poem to be stored in your brain. But clearly I
can claim no rights over that copy so long as you remain a free and autonomous individual. That copy in your
head is yours and no one else's. But now suppose you proceed to transcribe my poem, to make a "hard copy" of the
information stored in your brain. The materials you use — pen and ink — are your own property. The
information template which you used — that is, the stored memory of the poem — is also your own
property. So how can the hard copy you produce from these materials be anything but yours to publish,
sell, adapt, or otherwise treat as you please? An item of intellectual property is a universal. Unless we are to believe in Platonic Forms,
universals as such do not exist, except insofar as they are realized in their many particular instances. Accordingly, I do not see how
anyone can claim to own, say, the text of Atlas Shrugged unless that amounts to a claim to own every
single physical copy of Atlas Shrugged. But the copy of Atlas Shrugged on my bookshelf does not belong
to Ayn Rand or to her estate. It belongs to me. I bought it. I paid for it. (Rand presumably got royalties from the sale, and I'm
sure it wasn't sold without her permission!) The moral case against patents is even clearer. A patent is, in effect, a claim of
ownership over a law of nature. What if Newton had claimed to own calculus, or the law of gravity? Would
we have to pay a fee to his estate every time we used one of the principles he discovered? "... the patent monopoly ... consists in
protecting inventors ... against competition for a period long enough to extort from the people a reward
enormously in excess of the labor measure of their services, — in other words, in giving certain people a right
of property for a term of years in laws and facts of Nature, and the power to exact tribute from others
for the use of this natural wealth, which should be open to all." (Benjamin Tucker, Instead of a Book, By a Man Too Busy
to Write One: A Fragmentary Exposition of Philosophical Anarchism (New York: Tucker, 1893), p. 13.) Defenders of patents claim that
patent laws protect ownership only of inventions, not of discoveries. (Likewise, defenders of copyright
claim that copyright laws protect only implementations of ideas, not the ideas themselves.) But this
distinction is an artificial one. Laws of nature come in varying degrees of generality and specificity; if it is
a law of nature that copper conducts electricity, it is no less a law of nature that this much copper, arranged in
this configuration, with these other materials arranged so, makes a workable battery. And so on. Suppose you are trapped at
the bottom of a ravine. Sabre-tooth tigers are approaching hungrily. Your only hope is to quickly construct a levitation device I've recently
invented. You know how it works, because you attended a public lecture I gave on the topic. And it's easy to construct, quite rapidly, out of
materials you see lying around in the ravine. But there's a problem. I've patented my levitation device. I own it — not just the individual model I
built, but the universal. Thus, you can't construct your means of escape without using my property. And I, mean old skinflint that I am, refuse to
give my permission. And so the tigers dine well. This highlights the moral problem with the notion of intellectual property. By
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patent on my levitation device, I'm saying that you are not permitted to use your own knowledge to further
your ends. By what right? Another problem with patents is that, when it comes to laws of nature, even fairly specific ones, the odds are
quite good that two people, working independently but drawing on the same background of research, may
come up with the same invention (discovery) independently. Yet patent law will arbitrarily grant exclusive rights
to the inventor who reaches the patent office first; the second inventor, despite having developed the
idea on his own, will be forbidden to market his invention. Ayn Rand attempts to rebut this objection: "As an objection to
the patent laws, some people cite the fact that two inventors may work independently for years on the same invention, but one will beat the
other to the patent office by an hour or a day and will acquire an exclusive monopoly, while the loser's work will then be totally wasted. This
type of objection is based on the error of equating the potential with the actual. The fact that a man might have been first, does not alter the
fact that he wasn't. Since the issue is one of commercial rights, the loser in a case of that kind has to accept the fact that in seeking to trade
with others he must face the possibility of a competitor winning the race, which is true of all types of competition." (Ayn Rand, Capitalism: The
Unknown Ideal (New York: New American Library, 1967), p. 133.) But this reply will not do. Rand is suggesting that the competition to get to the
patent office first is like any other kind of commercial competition. For example, suppose you
and I are competing for the
same job, and you happen to get hired simply because you got to the employer before I did. In that case, the fact
that I might have gotten there first does not give me any rightful claim to the job. But that is because I have no right to the job in the first place.
And once you get the job, your rightful claim to that job depends solely on the fact that your employer chose to hire you. In the case of patents,
however, the story is supposed to be different. The
basis of an inventor's claim to a patent on X is supposedly the fact
that he has invented X. (Otherwise, why not offer patent rights over X to anyone who stumbles into the patent office, regardless of
whether they've ever even heard of X?) Registering one's invention with the patent office is supposed to record
one's right, not to create it. Hence it follows that the person who arrives at the patent office second has just as
much right as the one who arrives first — and this is surely a reductio ad absurdum of the whole notion of
patents. The Economic Argument
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Negative
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Contention 1: Innovation
Patents are the prerequisite to medical innovation increase average life expectancy
Roin 9 [Benjamin Roin, Assistant Professor of Technological Innovation at MIT, 02-2009, “Unpatentable
Drugs and the Standards of Patentability,” Texas Law Review, https://www-proquestcom.ezproxy.library.unlv.edu/docview/203704797?pq-origsite=primo]/Kankee
II. Background: Patents and Pharmaceutical Innovation Pharmaceutical
innovation is often seen as the golden child of the
patent system, with patents taking credit for the discovery and development of valuable new drugs that provide
tremendous health benefits to the public.4 The purpose of the patent system is to encourage socially valuable
investments in R&D that firms would not otherwise make due to the profit-eroding effects of
competition. In the pharmaceutical industry, firms must invest hundreds of millions of dollars in clinical trials on
their drugs before they can be sold to the public, while their generic rivals are exempted from those requirements
and can enter the market at low cost. Without some way to delay generic competition, therefore,
pharmaceutical companies would usually find it impossible to recoup their R&D investments and would likely
invest their money elsewhere. With strong patent protection, however, firms can expect to enjoy a lengthy monopoly over
their drugs, providing them an opportunity to profit from their investment in R&D. Although the public suffers from
high prices for drugs while they are covered by a patent, most of those drugs probably would not have been developed
without that protection. As a result, it is widely thought that the benefits of drug patents far outweigh their costs. The economic
function of the patent system is to promote the creation, development, and commercialization of inventions.5 Successful innovation can
be of great value to society, but it often requires significant investments in R&D.6 The public relies on private industry to
provide most of that investment,7 and unless firms expect to profit from their R&D efforts, they are likely to spend their money on something
else. Appropriating
the returns from an R&D investment can be difficult in a competitive market since
other firms may be able to imitate successful inventions without incurring the same costs and risks.8 The
resulting price competition can undermine the original inventors' profits as competitors free ride off of
their efforts. The patent system is an attempt to preserve the incentive to invest in R&D that would otherwise be vulnerable to free riding
by awarding inventors temporary exclusive rights to make, use, and sell their inventions, thereby protecting them from the profit-eroding
effects of competition.9 Although patent-law scholars typically focus on the role of patents in promoting inventive activity,10 patents can be
equally important in encourag- ing investment in the subsequent development and commercialization of inventions." The idea for an invention
is usually of little value to the public until it has been turned into a marketable product,12 and the process of doing so can be both risky and
expensive. Indeed, the cost and risk of bringing an invention to market is often much greater than that faced during the initial research that
gave rise to the invention.13 If competitors can produce and sell copies of the invention while avoiding its development and commercialization costs, then there may be little or no incentive for firms to ever bring that invention to market. Under these circumstances, a patent can be
essential for the investment that enables the practical use of an invention - a fact known to economists for at least 100 years.14 Even when
patents are unnecessary for motivating the creation of an invention, therefore, they can still be critical for encouraging the subsequent
investment in its development. Of course, not all inventions need a patent to incent their development and commercialization.15 In many cases
the costs and risks of getting an invention to market are relatively small, and the inherent lead-time advantage that the inventors will enjoy
over competitors is sufficient for them to recoup their R&D investments.16 In other cases patents are unnecessary for motivating postinvention spending because those investments are not vulnerable to free riding. For example, a firm might be willing to build an expensive new
manufacturing plant to produce an unpatented invention because competitors would have to make the same investment in building their own
plant before they could launch an imitation product.17 Additionally, on some occasions the underlying invention does not need a patent
because the efforts to develop and commercialize it give rise to their own patentable invention,18 which can make it difficult for competitors to
capitalize on the innovative firm's post-invention expenses.19 In any of these situations, the absence of patent protection for an invention may
not deter its development. For some inventions, however, patents do play
an essential role in promoting development and
commercialization, and drugs are a clear example.20 Pharmaceutical companies on average spend upwards of
$800 million on R&D for each new drug that reaches the market.21 Roughly half of that money is spent satisfying
the FDA's clinical-trial requirements to establish the safety and efficacy of new drugs,22 producing data
that cannot be protected with patents.23 Meanwhile, generics are exempted from the FDA's clinical-trial
requirements and enter the market based on the clinicaltrial data submitted by the original pharmaceutical company.24 As a result,
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generic-drug manufacturers spend on average only about $2 million on the approval process.25 Once they
are on the market, those drugs dramatically reduce the sales of (and profits from) the brand-name drugs they
imitate.26 Pharmaceutical companies therefore rely on a lengthy period of market exclusivity to recoup their investments in developing new
drugs. With strong patent protection, they are usually able to keep generics off the market for somewhere between ten and fourteen years27
and will invest hundreds of million of dollars in R&D in anticipation of this reward.28 For this reason, scholars often
view drug
development as "the paradigm of patents spurring innovation."29 Relying on the patent system to promote
pharmaceutical innovation admittedly has its costs, since patents allow manufacturers to charge premium prices for their products.30 Although
pharmaceutical companies sink vast sums of money into R&D of new drugs, the actual costs of manufacturing those drugs is usually quite
low.31 Generic drugs are sold at prices that reflect these lower production costs, whereas patented drugs are priced much higher.32 When a
drug is patented, therefore, some consumers who would be willing to buy it at the generic price are forced out of the market, and they must
wait until the patent on the drug expires before benefiting from its use. Economists refer to this harm as deadweight loss, and it is a problem
inherent in the patent system.33 With pharmaceuticals, the deadweight loss caused by patent protection is especially troubling because some
people must forgo the use of drugs that would improve their health and sometimes even save their lives.34 Although the temporary high prices
that result from patent protection are a significant problem, the benefits of the patent system can sometimes outweigh these costs. The public
may suffer for a time from the higher prices charged for a patented invention, but that harm is necessarily smaller than the injury that would
result if no one ever created or developed the invention in the first place, or if it had taken much longer for the invention to reach the public. As
a rule of thumb, therefore, patents are socially desirable when, in their absence, the public would not otherwise benefit from the invention or
there would be a substantial delay in the public's receipt of that benefit.35 The pharmaceutical industry is probably the best example of where
patents are socially desirable under this rule of thumb because patents
appear to be a prerequisite for the vast majority of
pharmaceutical innovation.36 Given their high R&D costs compared to those of their generic rivals,
pharmaceutical companies rely on lengthy periods of market exclusivitynormally ten or more years for the drugs
currently developed- to support their investments in bringing drugs to market.37 Not surprisingly, firms in the industry consistently
report that patent protection is essential to their efforts to discover and develop new drugs.38 Moreover, it is well known that
pharmaceutical companies generally refuse to develop new drugs unless they have strong patent protection
over them.39 Indeed, drug researchers who work in government and academia report that when they are looking for partners in private
industry to fund the development of the drugs they discover, it is almost impossible to attract interest unless the drugs are
patented.40 Some scholars even worry that the patent system may be too effective at promoting pharmaceutical innovation,41 although
the available evidence indicates that society's investment in pharmaceutical R&D continues to generate substantial positive returns. In theory,
the patent system could be harming the public by causing wasteful and duplicative R&D in "patent races."42 In the case of pharmaceuticals,
however, numerous economic studies have found that the social benefits produced by new medical technologies signifi- cantly outweigh the
costs of society's investment in medical R&D.43 According to one estimate, the
average new drug launch in the United States
increases average life expectancy among the U.S. population by about one week, leading to a costeffectiveness ratio for pharmaceutical R&D spending of $6,750 for each additional year of life saved.44
Since most studies put the value of a year of life at $75,000 to $150,000 ,45 the social return on pharma- ceutical
R&D investments appears to be extraordinarily high.46 This is not to say that all investments in pharmaceutical R&D are
beneficial, because some of that spending goes toward drugs that fail to complete the FDA's clinical- trial requirements,47 drugs that offer little
or no therapeutic advantage over existing drugs,48 and sometimes even drugs that do more harm than good,49 such as the now-infamous pain
reliever Vioxx®.50 On the whole, however, society's investments in discovering and developing new drugs seem to yield substantial net
benefits. The discussion above demonstrates why the case for the patent system is at its strongest in the pharmaceutical industry:
innovation in the field is incredibly valuable to society and most of it would not occur without the patent system.51 Indeed,
it is considered well established that the availability of patent protection for drugs improves social welfare.52 This is not to say that the patent
system is perfect; no one questions that the public suffers greatly from high drug prices. At the moment, however, the public depends on the
patent system to promote pharmaceutical innovation, and the public usually benefits when the system is successful in that task. III. The
Patentability Standards for Pharmaceuticals: Rewarding the Invention of Drugs but Not Their Development
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Patents are key to global South pharmaceutical industries that stop neglected diseases
Soyeju and Wabwire 18 [Olufemi Soyeju, Lecturer at Lagos State University, and Joshua Wabwire,
educator at the Catholic University of Eastern Africa, 01-2018, “The WTO-TRIPS Flexibilities on Public
Health: A Critical Appraisal of the East African Community Regional Framework,” World Trade Review;
Cambridge https://www-proquestcom.ezproxy.library.unlv.edu/docview/1994279823?accountid=3611&pq-origsite=primo]/Kankee
Conclusions The problem that this research has highlighted is the already too familiar tension between patent protection and access to
medicines. The legal framework for patents and access to medicines in the EAC region consists of the Policy and the accompanying Protocol.
What has emerged from the analysis is that the policy
tools are aimed at enhancing access to medicines mainly
through price reduction. This is done at the direct expense of promoting research and development of
medicines, which, in line with the utilitarian justification, is achievable through patent protection. This policy position
that weakens patent protection is not appropriate for developing African countries. This is because
African countries are faced with peculiar, region-specific diseases. Currently, these diseases are largely
neglected by the profit-driven pharmaceutical companies, which do not have economic incentives to
invest in developing medicines for populations that cannot afford to pay for them. Most of these pharmaceutical
companies are foreign, largely based in the Global North. Since these companies do not have economic
incentives to invest in the research and development of medicines for developing countries' diseases,
even patent protection has not necessarily been an attractive incentive.194The focus of these companies is
now on developed countries' diseases. In these circumstances, the only standing incentive, especially for
spurring domestic innovation from within developing countries, is patent protection. Consequently, any
strategy that eliminates this last straw will only worsen the already bad situation. The situation described
above underscores the urgent need to develop local pharmaceutical industries and to create alternative
incentives for investment in research and development of medicines for neglected diseases, for example
through Public-Private Partnerships (PPPs). Both of these can be attained through an appropriate patent protection
regime that does not weaken patent protection. Such a regime must, for instance, be omniscient of domestic innovators' limited capacity
and, consequently, avoid strict patentability criteria, which cannot be met by the small-scale, underfunded domestic innovators. Strict
patentability criteria may also discourage disclosure of certain important discoveries, for fear of not attaining the criteria and losing out by
disclosure. In
developing local pharmaceutical industries, it is also necessary to find ways of affording
patent protection to indigenous medicines and practices, which, for centuries, have been as useful to the
populations as western medicine now is. It is the failure to protect these medicines and practices in the
first place that has resulted in foreign pharmaceuticals appropriating the knowledge and patenting it,
only to return with expensive medicines.195 It is the argument here that a patent protection policy would only achieve the
greatest good for the greatest number of people, in line with utilitarianism, if it balances the goal of price reduction with the need to encourage
further research and development of medicines by ensuring that inventors are able to recoup their investments in research and development.
It is only through research and development that the medicines will be made available.
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Empirics prove lower vaccine profit margins harms future innovation – R&D
investments solve the aff by supplying vaccines globally
Roberts 6-25 [James M. Roberts, Research Fellow For Economic Freedom and Growth at the Heritage
Foundation with a master’s degree in international and development economics from Yale University, 625-2021, "Biden’s OK of Global Theft of America’s Intellectual Property Is Wrong, Dangerous," Heritage
Foundation, https://www.heritage.org/public-health/commentary/bidens-ok-global-theft-americasintellectual-property-wrong-dangerous]/Kankee
Mr. Biden wants to waive the World Trade Organization’s “Trade-Related Aspects of Intellectual Property Rights” (TRIPS) agreement for U.S.
vaccines and let foreign countries issue “compulsory licenses“ allowing their domestic pharmaceutical companies to manufacture the medicines
without adequately compensating the companies that invented them. Practically speaking, countries such as India and South Africa are unlikely
to manufacture the vaccines. They lack an advanced infrastructure for cold supply-chain distribution and many other crucial resources required
by these products’ capital-intensive, state-of-the-art manufacturing process. But the Biden policy is bad for many other reasons. Developing
breakthrough medications takes tremendous ingenuity and immense financial investments. It’s an
extraordinarily high-risk endeavor, and the prospect of making a profit is what convinces private companies to
undertake those risks. Signaling that the United States will not fight to defend their intellectual property
rights actively undermines innovation and manufacturing in American health care and medicines. It also erodes
patient protections by undermining quality control. Foreign companies may take the president’s policy
as a green light to produce reverse-engineered, counterfeit substitutes. Already there are reports of
ineffective and even dangerous counterfeit COVID-19 vaccines being sold around the world. Those pushing to break U.S.
pharmaceutical patents say they want to do so for altruistic reasons. Consequently, they also insist that the prices for the medications be set far
below their actual value. But history shows us that forcing
private companies to provide vaccines at an “affordable
price,” regardless of the cost to the companies, actually impedes the manufacture of high-quality vaccines.
Moreover, it inhibits the future development of vaccines needed to meet as-yet-unknown diseases.
Washington first imposed vaccine price controls as part of Hillary Clinton’s 1993 healthcare-for-all crusade. As
the Wall Street Journal later noted, it was a body blow to the U.S. vaccine industry. Ironically, government-decreed
prices left the companies unable to produce enough vaccines to meet Mrs. Clinton’s admittedly admirable goal
of universal immunization of children. Since then, U.S. firms have largely eschewed the vaccine market
because they could not recoup their R&D and manufacturing costs and earn enough profit to fund future
innovation. Ultimately, compulsory licensing legalizes the theft of intellectual property. Recognizing this, senators
from both sides of the aisle have joined with other government officials and industry leaders to call on the administration to reverse this bad
decision. The
U.S. patent protection system has served the nation well since its founding. It is and has been a bulwark of
American prosperity, but the strength of that protection has been weakening in the past few decades. Compulsory licensing
contributes to the erosion of that protection. As the U.S. and the rest of the world emerge from the
pandemic, it is clear that more innovative medicines and vaccines will be needed for future protection
from viruses and other emerging biological threats. The best way to prevent and treat those new diseases is
to ensure that private American pharmaceutical companies continue their innovative research and vaccine
production. That way, U.S.-manufactured vaccines can be made available to all Americans quickly. And governments can
subsidize their export and sale to other countries far more effectively and less expensively than through
compulsory licensing schemes. Meanwhile, let’s hope Mr. Biden listens to the more reasonable and less-agenda driven voices in this
debate and reverses course on the TRIPS waiver.
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High drug prices are a substitute for government funding the aff can’t provide
Mullainathan 17 [Sendhil Mullainathan, University Professor of Computation and Behavioral Science
at Chicago Booth, 6-30-2017, "High Drug Prices Are Bad. Cutting Them Could Be Worse. (Published
2017)," No Publication, https://www.nytimes.com/2017/06/30/upshot/high-drug-prices-are-badcutting-them-could-be-worse.html]/Kankee
High drug prices are harmful. Medical costs and out-of-pocket expenses result in high rates of bankruptcies, and 10-25 percent of patients
either delay, abandon or compromise treatments because of financial constraints. Survival is also compromised. For example, in chronic
myeloid leukemia, the 8-10 year survival rate is 80 percent in Europe (where treatment is universally affordable); in the U.S., where finances
may limit access to drugs, the 5-year survival is 60 percent. In surveys, 78 percent of Americans worry most about costs of drugs. Sadly, three
years after the issue was raised, there has been little progress. The problem is compounded by 2 additional factors. First is the increasing shift
in the cost of care and drugs to patients. Insurers justify this "skin-in-the-game" strategy as effective in reducing costs, but the high out-ofpocket expenses have turned this into "deterrence-in-the-game," discouraging patients from seeking care or purchasing drugs. In a recent
survey, one-third of insured Texans delayed or did not pursue care because of high out-of-pocket expenses. Second is the spill-over of high drug
prices to generics. Complex regulatory issues and shortages allow companies to increase prices of generics to levels as high as patented drugs.
The latest scandals – Turing, Valiant and Mylan – are only the most extreme examples of a common strategy in pricing drugs. Generic Imatinib
to treat chronic myeloid leukemia is priced at $5,000-8,000/year in Canada, $400/year in India, but $140,000/year in the U.S. For generic drugs
to be priced low, four to five generics have to be available. The average cost of filing for FDA approval of a drug is $5 million in 2016, and the
average time to approval is 4 years. There are currently more than 3,800 generic drug applications awaiting FDA action. The FDA should
overhaul its procedures to reduce the cost of filing to less than $1 million per drug, reduce the timeline to approval to 6-12 months and monitor
for the availability of multiple generics at all times. Because industry pays for a large share of research, high drug prices do not just generate
profits; they also become a funding source for important scientific work. In some cases, the experimental drugs that provide meager benefits to
the patients taking them are indirectly providing a much broader public good. Take Inclisiran, a drug that recently completed Phase 2 trials in
which it showed remarkable reductions in LDL cholesterol levels. Since cholesterol levels are only a marker for disease, more trials are needed
to determine how the drug actually affects more consequential outcomes such as heart attacks and strokes. It’s possible that these future trials
will yield disappointing news: Cholesterol reductions may simply not translate into particularly impressive health benefits. Yet whatever its
ultimate health benefits turn out to be, Inclisiran is anything but incremental. To the contrary, it is cutting edge in one important way. It relies
on a novel mechanism for producing its effects, directly targeting genes that are known to increase cholesterol levels via a mechanism known
as RNA interference. Biologists have known about RNA interference for some time: Andrew Z. Fire and Craig C. Mello shared the 2006 Nobel
Prize for their 1998 work on it. But translating these insights into medical advances is an arduous process. The Inclisiran effort is not only one of
the largest drug trials that exploits this mechanism, but it also manages to target an ailment that afflicts a broad swath of the population. In
short, the
drug’s ultimate value cannot be measured in its immediate benefits to patients alone. The research
all the way through to the clinical trial — can have ripple effects.
Work like this expands our understanding of how to harness a biological mechanism into a practical
therapeutic. Who knows how many unexpected therapeutics based on RNA interference will build on the lessons
learned in the process of producing this and other drugs like it? Research is not just about what is discovered but facilitating others’
that went into this drug — from basic science
discovery. Groundbreaking work is needed to lay the foundation for someone else’s skyscraper: The wonder drugs of today are built on
previous failures and marginal successes. Perversely, curbing
prices risks squeezing out this kind of innovation. The
consequences will not be felt today, but it could be a disaster in years to come. Constrict that research pipeline, and
we reduce our chance of future breakthroughs. Of course, research that benefits many others, not just the researcher, is
exactly what government should be funding. Such research is a public good, yet we are relying largely on the private
sector to provide it. Huge pharmaceutical profits from overpriced drugs are an extremely indirect way to fund the foundational research.
Now let me be clear. I am not supporting the current setup. It’s an extremely indirect and wasteful way to build the foundation of knowledge.
Most of the additional profits from overly lucrative drugs go elsewhere, not to research. Even the dollars that are funneled toward research and
development do not go toward the cutting-edge foundational research that others can build upon. Worst of all, even when the money does go
toward such research, no one else may ever benefit from it. The Inclisiran trial was published in The New England Journal of Medicine, but
pharmaceutical research is not always so public: Results may never be published. Hidden discoveries or failures do not contribute to the public
good. Despite these glaring
problems, current policy choices must confront the real world we are living in. In
pricing and research funding are intertwined. This link is only becoming more important. But,
unfortunately, the Trump administration has been considering an executive order that eases regulations on drug companies,
even as it has proposed cuts in federal funding for drug research. The net effect would increase our
reliance on private companies to provide public research. Instead, we should look to cut drug prices, but
couple those cuts with increased funding, in some form, for work on novel drugs that lay the foundation for future
the current situation, drug
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discoveries. While
the current setup may be a foolish way of funding research, it would be much worse to
have no funding at all.
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Contention 2: Single Payer CP
COUNTERPLAN – The United States federal government should maintain intellectual
property protections for medicines and establish a national single-payer healthcare
system covering all essential medicines and services.
Single-payer solves the pandemic by covering the uninsured
Galvani 20 [Alison P. Galvani, Burnett and Stender Families Professor of Epidemiology at Yale, 6-12020, "The imperative for universal healthcare to curtail the COVID-19 outbreak in the USA,"
EClinicalMedicine, https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(20)301243/fulltext]/Kankee
The COVID-19 outbreak in the United States is growing steeply and spreading widely. As of March 26, national incidence surpassed every other
country, and as of April 28 has reported over a million cases. The COVID-19 crisis is exposing the systemic frailties in our healthcare system.
More than 78 million people in America do not have access to adequate health insurance [[1]]. Given
that health insurance in the
US is typically provided by employers, millions more are at risk of losing their healthcare coverage as
unemployment surges. Here we discuss how the pervasive healthcare insecurity in the US hampers control of
COVID-19. Further, we argue that universal healthcare would alleviate the cost barriers that are impeding
control of this pandemic. Outbreak mitigation relies on prompt diagnosis and case-isolation, in which mild
cases are quarantined at home and more severe cases are hospitalized. These measures must be implemented
rapidly in order to be effective. However, for the millions of people who are either uninsured or underinsured,
concern about the medical expenses that could be incurred delays diagnosis and treatment. While the Families First
Coronavirus Response Act recently approved by Congress stipulates that COVID-19 diagnostic testing is nominally free for everyone,
treatment is not covered. Those who are hospitalized may face major medical expenses. For instance, the cost
of 12 days in the ICU on ventilation would likely exceed US $80,000 [[2],[3]], even without considering the
additional hospital care before and after ICU admission. In addition to the burden on the uninsured, the under-insured are
obligated to pay substantial out-of-pocket sums, including thousands of dollars in deductibles and copays. Although the Coronavirus
Aid, Relief, and Economic Security Act has invested $100 billion into the Public Health and Social Service
Emergency Fund for healthcare providers, less than one third of this sum can be used to fund the treatment of
uninsured COVID-19 patients. Compounding the crisis, legal action being pursued by the current Administration is jeopardizing the
Affordable Care Act, which would lead to the loss of health insurance for as many as 30 million people [[4]]. The COVID-19 pandemic also
underscores the precariousness of a system in which insurance is linked to employment. Initial
unemployment claims rose from 282,000 for the week ending March 14 to 6.6 million, 5.2 million and 4.4 million, for the weeks
ending April 4, April 11, and April 18, respectively, compared with a previous record high of 695,000 from 1982 [[5]]. Many of these newly
unemployed individuals will lose their health insurance. Although they are permitted to purchase insurance on the federal
exchange, switching networks disrupts continuity of care, which is particularly detrimental for those living with chronic health conditions.
Furthermore, the
majority of families are unable to afford health insurance upon becoming unemployed,
given that more than half of American families live paycheck to paycheck [[6]]. Racial and economic disparities in
the US healthcare system are being magnified by the pandemic. Rates of adequate health insurance coverage are much lower among people of
color [[7]]. With less access to preventative healthcare, people of color are disproportionately affected by comorbidities, such as diabetes,
obesity, asthma, and cardiovascular disease. These comorbidities exacerbate the severity of COVID-19 clinical outcomes, including death [[8]],
as does delay in seeking care due to concerns about medical bills. COVID-19 is widening socioeconomic fissures facing people of color as well.
Since the start of the outbreak, Latino populations have reported much higher rates of job and wage loss than Americans at large [[9]]. The
solution to these challenges is the provision of comprehensive healthcare as a human right. Further, universal healthcare will be most costeffectively achieved by a single-payer system, such as that proposed in the Medicare for All Act [[1]]. Not only would Medicare-for74
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All save lives, it would resolve costly inefficiencies that currently make our healthcare system the most
expensive in the world. Among the major sources of savings, a single-payer system would consolidate
administrative costs, reduce overhead, empower pharmaceutical price negotiations, and truncate
executive pay. A single-payer system is also incentivized to invest in cost-effective preventative services
that can avert life-threatening clinical outcomes and expensive downstream treatment. Another advantage of
Medicare-for-All during this pandemic would be its implementation of a standard billing and payment system,
which would accelerate COVID-19 case reporting. Billing procedures currently vary across dozens of
insurers, and for private insurance is proprietary. Within a consolidated system, patterns in the billing
data can signal outbreak hotspots to public health surveillance officials. This consideration is not hypothetical – the
single-payer system in Taiwan has facilitated exhaustive COVID-19 data collection and reporting [[10]]. Universal
healthcare is fundamental to the continued prosperity of our country in the wake of this and future infectious disease threats. Obstacles to
prompt diagnosis and case isolation not only impact the individual, but pose a broader societal risk. A pandemic
illustrates an omnipresent truth: that we are each only as safe as the most vulnerable member of our society. We urge investment now in the
common good of healthcare security, by extending comprehensive insurance to all who currently lack it. Then, we should move swiftly to create
a single-payer system, such as Medicare for All, which is the more efficient way to provide universal coverage [[1]]. By
eliminating
financial obstacles to healthcare, we can pave the way for more efficient outbreak control, in both this pandemic and
the next.
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Single-payer aids innovation, but patents are key to sustaining US biotech
Lemley et al. 20 [MARK A. LEMLEY, William H. Neukom Professor of Law, Stanford Law School, LISA
LARRIMORE OUELLETTE, Associate Professor of Law and Justin M. Roach, Jr. Faculty Scholar, Stanford
Law School, and RACHEL E. SACHS, Associate Professor of Law, Washington University, 04-2020, “THE
MEDICARE INNOVATION SUBSIDY,” NYU Law Review, https://www.nyulawreview.org/wpcontent/uploads/2020/04/NYULAWREVIEW-95-1-LemleyOuelletteSachs.pdf]/Kankee
II PHARMACEUTICAL SUBSIDIES AS INNOVATION INCENTIVES Governments have created the complex array of prescription drug allocation
mechanisms described in Part I because those drugs are costly and public payers face tradeoffs about how to allocate scarce resources. As
noted above, the
ability of drug manufacturers to set prices well above the cost of production stems from the
IP used to protect R&D investments.168 This ex post, market-set incentive is provided not only through patent
law, but also through other forms of IP, including trade secrets, trademarks, and regulatory exclusivity.169 It
is hard to disentangle the effects of these different forms of IP, but companies generally report that the pharmaceutical
industry is the sector in which patents are most effective,170 and scholars often agree.171 But patents and other
forms of IP come with significant drawbacks. They raise prices, impose administrative costs, and can discourage follow-on innovation. As
discussed below, market-based IP rewards are misaligned from social value for a variety of biomedical innovations, including for goods that
generate positive externalities or for which the social value exceeds consumers’ ability to pay. Governments can offset these IP-related biases
with other innovation policies, including R&D tax incentives, direct funding through grants and research at national labs, and prizes.172 Here,
we focus on one such policy tool—one that policymakers have rarely seemed to think of as implementing innovation policy at all:
government subsidies for particular drugs through health insurance programs like Medicare and Medicaid. From an
incentive perspective, reimbursement programs can function as market-based prizes, in which the reward incorporates
both a government assessment of social value and market information based on consumer choices.173 For
example, suppose policymakers decide that the expected IP-based market reward is insufficient for incentivizing a vaccine for a particular
disease.174 The government could offer an additional fixed prize—say, $1 billion for the first firm to develop a cure. But to encourage
distribution of the vaccine and to tie the reward to some measure of patient preference, policymakers could also offer a market-based prize—
say, $100 per patient vaccinated. Particularly for interventions with positive externalities or high disparities between patients’ ability and
willingness to pay, administering this kind of additional
incentive through government health insurance
programs improves the alignment between the returns to innovation and social value. The incentive effect of
demand-side healthcare subsidies depends critically on details of institutional design. Section II.A shows how Medicare-like programs
can provide a significant subsidy to drug manufacturers beyond expected profits in an unsubsidized market. Section II.B
discusses the effect of this kind of subsidy on overall pharmaceutical innovation. Finally, Section II.C examines how subsidies from government
insurance can bias innovation incentives in favor of particular biomedical technologies. But those details should not obscure the larger point, to
which we turn in Part III: Healthcare
reimbursements are innovation incentives. Indeed, they may be among the
largest innovation incentives in the pharmaceutical sector. A. The Medicare Innovation Subsidy To illustrate how
pharmaceutical profits under Medicare reflect more than the “market value” of a drug, we begin with an ordinary, unsubsidized market in
which a seller has monopoly power, as illustrated in Figure 1. The demand curve (D) represents how much quantity of the drug (Q) consumers
will purchase at a given price (P); an ordinary market has a downward-sloping demand curve because more consumers are typically able to
purchase a good at lower prices.175 The supply curve (S) represents the quantity of drug that will be sold at a given price. Monopoly pricing
involves reducing sales in order to increase the price. Why
do monopolists reduce output while increasing prices? The key
patentee would like to sell to everyone who is
willing and able to pay more than it costs to sell them a drug: that is, everyone for whom the demand curve is higher
than the supply curve. But if they lower the price to reach those who can afford to pay less, they also lower the
price for all the other buyers, too, reducing the marginal revenue from adding a new sale. Monopolists,
then, price not where the supply curve meets the demand curve (the competitive market price),176 but instead
where the supply curve meets the marginal revenue curve (MR), resulting in a higher price (Pmonop) and
lower quantity (Qmonop) than in a competitive market. If they cut the price any further, the money they
would lose from existing customers would counteract the additional sales, making the additional sale
unprofitable. If this monopoly price is used to allocate access to the drug, consumers who value the drug
above the cost of production but below the monopoly price are unable to access the drug. The social loss due
to this “normal” monopoly is the absence of price discrimination. The
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to these lost transactions is known as deadweight loss (DWL), represented by the striped triangle in Figure 1. In the context of essential
medicines, this represents patients who will be unable to access the treatments they need. IP policy tolerates this
allocative inefficiency on the theory that it will be exceeded by gains in dynamic efficiency: The prospect of monopoly profits will incentivize a
producer to create this drug in the first place. In other words, the development of
the drug is necessary to provide any
access at all. IP policy is thus typically described as representing a tradeoff between short-term access and
longer-term innovation.177 The full interaction between IP and pharmaceutical access is more complicated than this simple model
suggests. One of us has recently questioned the conventional view that the fundamental tradeoff in IP is between dynamic and allocative
efficiency: IPfacilitated market power does create incentives to restrict quantity and thus decrease consumption, but it also has
consumptionexpanding effects.178 But for our purposes, the standard monopolypricing model suffices to illustrate the basic effect of insurance
and demand-side subsidies. In Figure 2 we add the effect of coinsurance, in which an insurer covers a fixed percentage of medical costs.
Compared to a market without insurance, a coinsurance system expands
demand, moving the demand curve to the right. The curve
pivots rather than simply shifting because coinsurance pays a percentage of the total cost, so it magnifies the
effect of a consumer’s existing willingness and ability to pay. If insurance pays 80% of the cost, a
consumer who can pay $100 out of pocket can buy a $500 drug. But a consumer who can pay $1000 ($900
more than her neighbor) can buy a $5000 drug.179 The effect of adding insurance is to expand the patent owner’s profits beyond the
monopoly profit without insurance. Because consumers effectively can pay more (with the help of their insurers), a
monopolist can charge each consumer more and can also sell to more consumers. Note that as patients’ share of costs
decreases, the demand curve pivots further to the right, and more consumers gain access to the drug. This effect is generally framed in the
health economics literature in terms of the resulting moral hazard problem in which patients may choose treatments that are more expensive
than the value they actually receive.180 But there has been less attention to the way insurance greatly increases prices and profits for a seller
with market power. If patients’ share of costs declines to zero (such as through insurance that requires only a flat copayment), then there
would be no upper bound on price. That’s why, as
a practical matter, public or private insurance systems providing free or
low-cost care must have some other mechanism to contain costs. For example, as described in Part I, Medicaid links prices to private
markets, the VA and UK systems can exclude drugs from coverage, and the German system will only reimburse up to a reference price.
Coinsurance systems in which insurers cover a large percentage of costs typically also have some cost-control mechanism, including
copayments, deductibles, and formulary management tools. But even
if there is some mechanism for limiting price, the
patentee may still receive additional profits in a market in which all patients have coinsurance as compared
with the “normal” monopoly market, as we illustrate in Figure 3.181 A mechanism for limiting prices is particularly necessary if the model
moves from one in which all consumers have coinsurance (requiring them to pay some percentage of the price) to one in which all consumers
have generous access to drugs with no cost-sharing, as suggested by some Medicare for All proposals.182 As we illustrate in Figure 4, even
if
prices are limited to the original monopoly price, providing coverage for all patients with no cost-sharing leads
to a substantial additional profit for the patentee.183 Real-world pharmaceutical markets are substantially more complex
than any of the simplified models shown in Figures 1–4. The important conceptual point, however, is that when insurance-related policies
effectively shift demand upward or to the right, the seller of a drug with market power can receive higher profits for that drug. These added
profits grow as patients’ share of pharmaceutical costs shrinks, particularly in the absence of robust cost-containment
mechanisms. To some degree, this is what Medicare’s prescription drug benefits do. Medicare beneficiaries generally are responsible for only
twenty to twenty-five percent of brand-name drug costs under Parts B and D,184 and millions of patients receive government subsidies
lowering these amounts.185 Many of these are people
who didn’t have private insurance or who had insurance that was less
generous,186 who can now effectively pay much more for drugs than they used to. Medicare also increases
overall demand for drugs by causing beneficiaries to live longer.187 These factors tend to push the demand curve
upward to the right, artificially adding to the number of people who can pay the monopoly price. And unlike private
insurers, who have greater legal authority to negotiate prices freely and to refuse to cover drugs that cost too much, Medicare Parts B and D
often impose coverage requirements with little ability for the government to negotiate prices beyond the price set in the private market, giving
drug manufacturers significant leverage in setting prices.188 Expanding the demand curve in this way increases the
patentee’s
profits even further beyond what they would make without government insurance. The patentee no longer
has to worry about cutting prices to match demand for customers who can pay less; some combination of the
government and supplemental private insurance will pay the monopoly price for almost everyone. Medicare does
expand access to consumers who value the drug more than its cost of production but less than the unsubsidized monopoly price (the striped
DWL triangle in Figure 1). But it also transfers a great deal of additional
profit to the patent owner. The scope and
duration of the patent hasn’t changed, but it is generating a lot more profit for the simple reason that, thanks
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to the government subsidy, there are many more customers who can pay and they all pay the monopoly
price or close to it, even if they value the drug at less than that price. We call this added profit the Medicare innovation subsidy. The real
world has more complications than this stylized model, of course. Here are four important ones: First, not all pharmaceutical patents confer
market power, though they are more likely to than patents in other fields.189 Even where drugs face quite a lot of competition, as with
antidepressants, patentees may not face effective price competition if doctors don’t view the drugs as substitutes for any given patient or if
Medicare must cover all FDA-approved drugs for certain illnesses.190 Second, Medicare plans and the PBMs that negotiate on their behalf do
have some bargaining leverage, including threatening to cover only certain drugs for non-protected classes, using prior authorization or step
therapy, and threatening to move drugs to less desirable formulary tiers.191 This leverage has allowed them to lower prices for drugs with
competition in a particular therapeutic class, although their bargaining power is limited by the government’s inability to directly negotiate and
by the plans’ inability to walk away from the table in most cases.192 As Figure 3 illustrates, however, patentees still receive substantial
additional profits even with tools for limiting price. Third, Medicare Part D covers primarily Americans aged over sixty-five. For drugs that affect
only the elderly, the model just described is accurate. But it doesn’t apply to drugs for diseases that only affect children, and it applies only
partially to drugs taken by patients of all ages. We discuss the biases this may cause in more detail in Section II.C. Finally, the above graphs
assume that Part D was created against a baseline in which seniors did not have prescription drug insurance. This was true for twenty-seven
percent of seniors,193 creating a demand expansion effect among this population. Before Part D implementation, sixty-six percent of Medicareeligible seniors already had some prescription drug insurance plan.194 However, at least some of those patients also increased pharmaceutical
returns when substituting into Medicare—nine million patients moved from lowerreimbursement Medicaid coverage to higher-reimbursement
Part D coverage.195 Effects may be more variable for the beneficiaries substituting from private insurance into Medicare. Despite these
complications, the
Medicare innovation subsidy is real. It has significantly increased the returns to
pharmaceutical patent owners. Medicare now accounts for thirty percent of U.S. retail prescription drug
spending,196 even though it applies primarily to people over sixty-five, who make up just thirteen percent of the population,197 and not all
of whom even opt-in to Medicare. Medicare, then, is a big source of additional money for drug companies, both
because it increases the number of people who can afford drugs and because it may increase the price companies can charge for those drugs.
B. Effect on Innovation Above-baseline-monopoly profits
aren’t necessarily bad. Few dispute that higher profits for
certain innovations increase incentives to produce those knowledge goods,198 and a number of empirical studies
have found increases in private-sector R&D investment following legal changes that increased market size
in the contexts of vaccines and orphan drugs.199 Based on analysis of time-series data of drugs entering clinical development, Margaret BlumeKohout and Neeraj Sood conclude that “passage and implementation of Medicare Part D is
associated with significant
increases in pharmaceutical R&D for therapeutic classes with higher Medicare market share.”200 They found that this was
largely new investment, not substitution away from other drugs, and that the effect was smaller for drugs that had
been previously covered under Part B and larger for drugs in protected Part D classes.201 (In contrast, the original introduction of Medicare in
1965—without the prescription drug benefit—didn’t increase drug use among the elderly or induce significant pharmaceutical innovation,202
though it did increase medical-equipment patenting.)203 True, increases in R&D alone do not necessarily enhance patient welfare. Subsequent
work focused on biologics found a similar incentive effect from Part D implementation, but also concluded that “most of
this effect is concentrated among products aimed at diseases that already have multiple existing treatments,”204 and the net welfare impact of
such drugs is ambiguous. Even though the size of the Medicare subsidy is large, its net innovation benefit might be relatively modest. The
United States offers a huge array of innovation incentives in the pharmaceutical industry already,
including not just patents but also direct research funding through grants and national laboratories, prizes, tax incentives, regulatory
exclusivities, data exclusivities, and special incentives for orphan drugs and pediatric research.205 Pharmaceutical “lifecycle management”
through secondary patents and regulatory gaming mean that companies keep market power for years and
even decades after initial patent expiration.206 For at least some drugs, patent-owner returns for
pharmaceuticals seem to far exceed the risk-adjusted R&D costs.207 Greatly increasing this innovation subsidy through
expansion of government insurance may thus lead to limited innovation gains— although, as discussed in the following Section, existing
incentives appear to be insufficient for at least some kinds of socially valuable innovation. Even so, perhaps we
should celebrate the
expansion of patent owner profits above the baseline monopoly level, since it seems to spur at least some additional
R&D investment. If Medicare Part D is justified solely for the access benefits it provides for the elderly, the fact that there is also an
innovation subsidy that leads to the production of even some new drugs is an extra benefit for the world. It is found money.
And more drugs to treat diseases for no extra cost seems like an unambiguously good thing.
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Single-payer is affordable
Galvani et al. 20 [Alison P Galvani, PhD, Alyssa S Parpia, MPH, Eric M Foster, Burton H Singer, PhD,
and Meagan C Fitzpatrick, PhD, 02-15-2020, “Improving the prognosis of health care in the USA,” Lancet,
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)33019-3/fulltext#%20]/Kankee
The bottom line of Medicare for All Through the mechanisms detailed previously, we
predict that a single-payer health-care system
would require $3·034 trillion annually (figure 3; appendix p 5), $458 billion less than national health-care
expenditure in 2017.40 Even after accounting for the increased costs of coverage expansion, our datadriven base case includes $59 billion savings on hospital care, $23 billion on physician and clinical services,
$217 billion on overheads, and $177 billion on prescription drugs (figure 3; appendix p 11). Consequently, annual
expenditure per capita would decrease from $10 7396 to $9330, equivalent to a 13·1% reduction. The
expectation of savings is robust and remains following variation in the input parameters. For example, if overhead costs
only dropped to 6% of total health expenditure—rather than Medicare’s current 2·2%—the Medicare for All Act
would still reduce costs by 10·3%. Conversely, savings would increase beyond our base case if our model
overestimates the unfulfilled demand in people who do not have insurance or are underinsured. Given that
$2261 billion is already allocated to health care by existing governmental and philanthropic sources (appendix p 5), a further $773 billion must
be collected by the government to fully fund the Medicare for All Act. Restructuring health-care expenditure by employers, individuals, and as a
country
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Contention 4: WTO Backlash DA
Congress won’t withdraw the US from the WTO now, but more unfair trade practices
abroad causes widespread backlash that ends involvement
Johnson 20 [Keith Johnson, a senior staff writer at Foreign Policy, 05-07-2020, “U.S. Effort to Depart
WTO Gathers Momentum,” Foreign Policy, https://foreignpolicy.com/2020/05/27/world-tradeorganization-united-states-departure-china/]/Kankee
Frustration with hyperglobalization, China’s “economic imperialism,” and a seemingly broken world trading system is boiling
over into serious calls for the United States to withdraw from the World Trade Organization (WTO)—which would
have potentially disastrous implications for the country if carried out. For the first time since 2005, lawmakers from both
parties and both houses of Congress are pushing to pull the United States out of the trading body it helped
create and which was the culmination of decades of postwar efforts to boost free trade and economic integration. By law, the United States has
a chance to vote every five years on staying inside the WTO, but staying on board was such a no-brainer in recent years that no such resolution
was even presented. But this year—powered
by a rise in economic nationalism, growing concern about China, and
frustration with two decades of paralysis at the WTO—the knives on Capitol Hill are out, to the delight of some of the
trade hard-liners in the White House. “The WTO has been a disaster for the United States,” said Rep. Peter DeFazio,
an Oregon Democrat, who introduced House legislation to withdraw this month. “No trade regime can last when it no longer
serves the people of the countries who are part of it,” said Sen. Josh Hawley, a Missouri Republican, in a recent Senate floor
speech after introducing his own resolution to leave. “Our interests and those of the WTO diverged long ago.” It’s
doubtful that the measures could secure enough votes for passage in either chamber, and a tight legislative
calendar makes the push for withdrawal doubly hard to pull off. But the rush for the exit is still a serious indication of deep
and growing dissatisfaction with how global trade has evolved, highlighted by the vulnerability of cross-border supply
chains that have begun to come apart under the stress of the COVID-19 pandemic. If the United States were to pull out of the system it helped
build, the implications would be dire. Other countries would be able to discriminate against U.S. goods and services with no limits. Tariffs would
almost certainly rise and export markets shrink. Meanwhile, others like China and the European Union would increasingly be in a position to
write the rules of the future economy, from data protection and privacy to intellectual property and state subsidies. “We’d have no rights, and
we’d lose a seat at the table,” said Wendy Cutler, a former U.S. trade negotiator now at the Asia Society. Why the big push now? For years,
different aspects of the global trading system have stirred concern and at times anger in the United States and other countries; the WTO has
essentially been stuck in place since the collapse of its last big negotiating round in 2008. For years, economists have debated the impact of the
so-called “China shock” on U.S. jobs and manufacturing, and some evidence has shown that the competition from low-wage Chinese labor and
the rapid movement of U.S. companies offshore hit the U.S. middle class harder than many economists expected. For years, Republicans
have railed against international organizations—from the WTO to the International Criminal Court—that they see as
encroaching on U.S. sovereignty. Now, all those forces have come together in a kind of imperfect storm.
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A major country operating outside WTO consensus wrecks global trade norms
Bacchus 20 [James Bacchus, member of the Herbert A. Stiefel Center for Trade Policy Studies, the
Distinguished University Professor of Global Affairs and director of the Center for Global Economic and
Environmental Opportunity at the University of Central Florida, 12-16-2020, "An Unnecessary Proposal:
A WTO Waiver of Intellectual Property Rights for COVID-19 Vaccines," Cato Institute,
https://www.cato.org/free-trade-bulletin/unnecessary-proposal-wto-waiver-intellectual-propertyrights-covid-19-vaccines]/Kankee
In a sign of their increasing frustration with global efforts to ensure that all people everywhere will have access to COVID-19 vaccines, several
developing countries have asked other members of the World Trade Organization (WTO) to join them in a sweeping waiver of the intellectual
property (IP) rights relating to those vaccines. Their waiver request raises anew the recurring debate within the WTO over the right balance
between the protection of IP rights and access in poorer countries to urgently needed medicines. But the
last thing the WTO needs
is another debate over perceived trade obstacles to public health. Unless WTO members reach a
consensus, the multilateral trading system may be further complicated by a delay like that in resolving
the two‐decades‐old dispute between developed and developing countries over the compulsory licensing and
generic distribution of HIV/AIDS drugs. A new and contentious “North‐South” political struggle definitely would not be
in the interest of the developed countries, the developing countries, the pharmaceutical companies, or the WTO. Certainly it would
not be in the interest of the victims and potential victims of COVID-19. Background In early October 2020, India and South Africa asked the
members of the WTO to waive protections in WTO rules for patents, copyrights, industrial designs, and undisclosed information (trade secrets)
in relation to the “prevention, containment or treatment of COVID-19 … until widespread vaccination is in place globally, and the majority of
the world’s population has developed immunity.”1 India and South Africa want to give all WTO members freedom to refuse to grant or enforce
patents and other IP rights relating to COVID-19 vaccines, drugs, diagnostics, and other technologies for the duration of the pandemic. In
requesting the waiver, India and South Africa have argued that “an effective response to the COVID-19 pandemic requires rapid access to
affordable medical products including diagnostic kits, medical masks, other personal protective equipment and ventilators, as well as vaccines
and medicines for the prevention and treatment of patients in dire need.” They have said that “as new diagnostics, therapeutics and vaccines
for COVID-19 are developed, there are significant concerns, how these will be made available promptly, in sufficient quantities and at
affordable prices to meet global demand.”2 Later in October, the members of the WTO failed to muster the required consensus to move
forward with the proposed waiver. The European Union, the United States, the United Kingdom, and other developed countries opposed the
waiver request.3 One WTO delegate, from the United Kingdom, described it as “an extreme measure to address an unproven problem.”4 A
spokesperson for the European Union explained, “There is no evidence that intellectual property rights are a genuine barrier for accessibility of
COVID‐19‐related medicines and technologies.”5 In the absence of a consensus, WTO members have decided to postpone further discussion of
the proposed waiver until early 2021. Balancing IP Rights and Access to Medicines Not New to WTO This waiver controversy comes nearly two
decades after the end of the long battle in the multilateral trading system over access to HIV/AIDS drugs. At
the height of the
HIV/AIDS crisis at the turn of the century, numerous countries, including especially those from sub‐Saharan Africa, could not
afford the high‐priced HIV/AIDS drugs patented by pharmaceutical companies in developed countries.
Having spent billions of dollars on developing the drugs, the patent holders resisted lowering their prices. The credibility of the
companies, the countries that supported them, and the WTO itself were all damaged by an extended controversy
over whether patent rights should take precedence over providing affordable medicines for people afflicted by a
lethal disease. Article 8 of the WTO Agreement on the Trade‐Related Aspects of Intellectual Property Rights (the TRIPS Agreement) provides
that WTO members “may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health …
provided that such measures are consistent with the provisions of this Agreement.” In similar vein, Article 7 of the TRIPS Agreement provides
that the “protection and enforcement of intellectual property rights” shall be “in a manner conducive to social and economic welfare.”6 It can
be maintained that these two WTO IP rules are significantly capacious to include any reasonable health measures that a WTO member may
take during a health emergency, such as a pandemic. Yet there
was doubt among the members during the HIV/AIDS crisis about
the precise reach of these provisions. As Jennifer Hillman of the Council on Foreign Relations observed, ordinarily the “inherent
tension between the protection of intellectual property and the need to make and distribute affordable medicines” is “resolved through
licensing, which allows a patent holder to permit others to make or trade the protected product—usually at a price and with some supervision
from the patent holder to ensure control.”7 But, in public health emergencies, it may be impossible to obtain a license. In such cases,
“compulsory licenses” can be issued to local manufacturers, authorizing them to make patented products or use patented processes even
though they do not have the permission of the patent holders.8
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Even small changes make pharma companies fear patent reform
Asgari et al. 21 [Nikou Asgari, markets reporter for the Financial Times, Donato Paolo Mancini, FT's
pharma reporter, and Hannah Kuchler, FT’s global pharmaceutical correspondent, 05-06-2021, "Pharma
industry fears Biden’s patent move sets precedent," FT, https://amp.ft.com/content/f54bf71b-87be4290-9c95-4d110eec7a90]/Kankee
Profits in the pharmaceutical industry are protected by a fortress of patents that guarantee drugmakers
a stream of income until they expire. On Wednesday, Joe Biden broke with decades of US orthodoxy and
made a crack in the wall. His administration’s decision to support a temporary waiver of Covid-19 vaccine
patents prompted instant outrage in the pharmaceutical sector, which argues that the move rides
roughshod over their intellectual property rights and will discourage US innovation while sending jobs
abroad. “Intellectual property is the lifeblood of biotech, it’s like oxygen to our industry,” said Brad Loncar, a
biotech investor. “If you take it away, you don’t have a biotech sector.” Biden’s top trade adviser Katherine Tai
said that while the US government still “believes strongly” in intellectual property protections, it supported waiving patents for Covid-19
vaccines to help boost global production of jabs. The move comes as some countries, including India, struggle to tackle further waves of the
virus even as others have rolled out successful vaccination campaigns that are driving down infections, hospitalisations and deaths. The waiver
proposal was put forward at the World Trade Organization in October and has since been supported by more than 60 countries who say
worldwide vaccine production must increase dramatically. Washington’s support marks a pivotal step in making the proposal a reality and Tai
said the
US would engage in negotiations to hammer out the details at the WTO. Tedros Adhanom
Ghebreyesus, the WHO’s director-general, told the Financial Times the decision was a “monumental
moment” in the fight against Covid-19. “I am not surprised by this announcement. This is what I expected from the administration of
President Biden.” However, the pharma industry did not expect it; the US has tended to fiercely protect
domestic companies’ intellectual property rights in trade disputes. Industry leaders described the
decision as a heavy blow for innovation that would do little to boost global production because there is a
shortage of manufacturing facilities and skilled employees. In an earnings call Thursday, Stéphane Bancel, chief executive of Moderna, said a
patent waiver “will not help supply more mRNA vaccines to the world any faster in 2021 and 2022, which is the most critical time of the
pandemic”. “There is no idle mRNA manufacturing capacity in the world,” he said. “The
administration’s steps here are very
unnecessary and damaging,” said Jeremy Levin, chair of biotech trade association Bio. “Securing vaccines rapidly
will not be the result, and worse yet, it sets a principle that companies who invested in new tech will stand the risk
of having that taken away.” Shares in the big makers of Covid-19 vaccines were hit by the
announcement. Frankfurt-listed shares in BioNTech closed down 12 per cent on Thursday while Moderna
and Novavax pared losses after tanking on Wednesday in New York, trading 2.4 per cent lower and 1 per cent
lower, respectively. CanSino Biologics, a Chinese private company that developed a single-shot adenovirus-vectored vaccine
with Chinese military researchers, fell 14 per cent on Thursday. Fosun Pharma, which has a deal to supply BioNTech vaccines in
China, lost 9 per cent. Sven Borho, a managing partner at OrbiMed Advisors, a healthcare investment
company, said pharma executives feared the administration’s move set a precedent that would make it
easier to suspend patents in the future. “They are worried in the long term that this is a foot in the door
— ‘OK, we did it with Covid-19, let’s do it with the next crisis, and the next one’,” he said. “And then suddenly
it’s a cancer drug patent that needs to be invalidated. They fear it is a mechanism that sets the stage for
actions in the future.” Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes, said there was a
potential trade-off that pitted the imminent need to contain the pandemic against the risk that drugmakers would be more cautious when
investing in pioneering therapies in the future.
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US withdrawal from the TWO collapses global trade and causes WWIII
Hopewell and Horton 08-03 [Kristen Hopewell Associate Professor and Canada Research Chair in
Global Policy at the University of British Columbia, and Ben Horton, Communications Manager; Project
Lead, Common Futures Conversations, 08-03-2021, "Lessons from Trump’s assault on the World Trade
Organization," Chatham House – International Affairs Think Tank,
https://www.chathamhouse.org/2021/08/lessons-trumps-assault-world-trade-organization]/Kankee
What has this episode revealed about the strength of multilateral institutions such as the WTO, in the face of spoiling tactics from major
powers? The
WTO is unique amongst international institutions because it has a powerful enforcement
mechanism – the dispute settlement system. However, the fundamental vulnerability is that if powerful states like the
US and others won’t participate in the system and be bound by its rules, they quickly risk becoming
irrelevant. And that’s the situation we’re in right now with the appellate body crisis, where, without a functioning mechanism to
ensure that WTO rules are enforced, the entire system of global trade rules risk collapsing. Ironically, the United States
has been the leader of the liberal trading order for the past 70 years, but since Trump, it has become its leading saboteur. What are the
implications of a permanent collapse of the international trading system? The very real danger from such a
breakdown is a return to what we saw in the 1930s. In response to the outbreak of the Great Depression, you
had countries imposing trade barriers, blocking imports from other state, and a general escalation of titfor-tat protectionism. This response wound up not only exacerbating the effects of the depression itself but has also been
credited by some as paving the way for the outbreak of the second world war. The reason why institutions like the
WTO were created in the first place was to prevent a recurrence of the 1930s protectionist trade spiral.
The danger now – if those rules become meaningless and unenforceable – is the institutional
foundations of postwar economic prosperity could unravel, throwing us back into economic chaos and
potentially political disorder. What does the WTO’s future look like under new director-general Dr Okonjo-Iweala?
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Contention 5: Infrastructure
Infrastructure will pass through reconciliation
Snell and Sprunt 08-24 [Kelsey Snell, Congressional correspondent for NPR with a graduate degree
in journalism from the Medill School of Journalism at Northwestern University, and Barbara Sprunt,
political producer on NPR's Washington desk and a graduate of American University, 8-24-2021, "House
Narrowly Approves $3.5 Trillion Budget Blueprint," NPR.org,
https://www.npr.org/2021/08/24/1030430715/house-democrats-3-5-trillion-budget-pelosi-moderates
The House of Representatives narrowly approved a budget resolution that provides the framework for a $3.5
trillion spending deal following an impasse between House leaders and centrist Democrats that threatened to derail progress on the
vast majority of President Biden's domestic agenda. Tuesday's vote was 220-212 along party lines. House leaders used
a procedural workaround to avoid a lengthy battle and a separate vote on the budget resolution itself, but
the rift between Democrats over how far Congress should go in reshaping the role of the federal government is still unresolved. At odds were a
group of moderates who wanted to vote now on a Senate-passed, bipartisan infrastructure bill instead of following through with a two-track
strategy, whereby infrastructure and the broader spending bill would advance in tandem. Party leaders say they hope to finish work on a
spending bill by Oct. 1, leaving just weeks to address serious concerns among centrists over the cost of Biden's spending plans. Democrats
are attempting to move forward with this spending legislation without the support of any Republicans — a plan that gives
leaders little room for error. Pelosi insisted two domestic bills should be tied together House Speaker Nancy Pelosi, D-Calif., pursued
a strategy of tying the fate of a $1 trillion bipartisan infrastructure bill to the broader spending plan full of Democratic priorities. She has
repeatedly insisted the House would not vote on the infrastructure bill until the Senate passes the larger spending package. Progressives worry
advancing a vote on infrastructure could lose much-needed momentum for the broader budget. After hours of late-night talks Monday,
Democratic leaders offered a compromise to the centrists who called for a vote on the infrastructure bill. Pelosi agreed to
add the budget vote into a procedural measure and add a provision specifying that the House would vote on the infrastructure bill by Sept. 27.
The procedural vote also set up debate and a vote on a voting rights bill for later Tuesday. "Passing an infrastructure bill is always exciting for
what it means in terms of jobs and commerce in our country," Pelosi said in a statement Tuesday afternoon announcing her commitment to the
Sept. 27 deadline. "We
must keep the 51-vote privilege by passing the budget and work with House and
Senate Democrats to reach agreement in order for the House to vote on a Build Back Better Act that will pass the
Senate." Each of the moderate lawmakers who had demanded an early vote on infrastructure ultimately fell into
step with Pelosi and voted for the measure. While they got a commitment on a date certain on the bipartisan bill, they did not
extract any assurances on the size or substance of the policies in the broader bill. Pelosi and other leaders have insisted that the only way to
make good on promises to address climate change and provide support to workers and families is to tie the two bills together. "I know we will
succeed because of the confidence I have in the shared values of all in our Caucus for America's working families," Pelosi told Democrats in a
letter sent Monday as negotiations dragged on between the two camps. "The success of each bill contributes to the success of the other." As
leaders worked to find the votes for the compromise, Pelosi told reporters Tuesday morning, "When
we bring up the bill, we will
have the votes." The House adopted the same budget resolution that was approved this month in the Senate.
Democrats plan to use a feature of the budget process, known as reconciliation, to avoid a Republican filibuster in
the Senate. But there is little agreement on what should be included once a budget is passed. Some moderate Democrats argued
infrastructure investments can't wait
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The pharma industry will fight to the death with the best lobbying money can buy to
preserve patent rights
Huetteman 20 [Emmarie Huetteman, former NYT Congressional correspondent with an MA in public
affairs reporting from Northwestern University’s Medill School, 2-26-2019, "Senators Who Led PharmaFriendly Patent Reform Also Prime Targets For Pharma Cash," Kaiser Health News,
https://khn.org/news/senators-who-led-pharma-friendly-patent-reform-also-prime-targets-for-pharmacash/]/Kankee
Early last year, as lawmakers vowed to curb rising drug prices, Sen. Thom Tillis was named chairman of the Senate Judiciary Committee’s
subcommittee on intellectual property rights, a committee that had not met since 2007. As the new gatekeeper for laws and oversight of the
nation’s patent system, the North Carolina Republican signaled he was determined to make it easier for American businesses to benefit from it
— a welcome message to the drugmakers who already leverage patents to block competitors and keep prices high. Less than three weeks after
introducing a bill that would make it harder for generic drugmakers to compete with patent-holding drugmakers, Tillis opened the
subcommittee’s first meeting on Feb. 26, 2019, with his own vow. “From the United States Patent and Trademark Office to the State
Department’s Office of Intellectual Property Enforcement, no department or bureau is too big or too small for this subcommittee to take
interest,” he said. “And we will.” In the months that followed, tens of thousands of dollars flowed from pharmaceutical companies toward his
campaign, as well as to the campaigns of other subcommittee members — including some who promised to stop drugmakers from playing
money-making games with the patent system, like Sen. John Cornyn (R-Texas). Tillis
received more than $156,000 from
political action committees tied to drug manufacturers in 2019, more than any other member of Congress, a new
analysis of KHN’s Pharma Cash to Congress database shows. Sen. Chris Coons (D-Del.), the top Democrat on the subcommittee who worked
side by side with Tillis, received more than $124,000 in drugmaker contributions last year, making him the No. 3 recipient in
Congress. No. 2 was Sen. Mitch McConnell (R-Ky.), who took in about $139,000. As the Senate majority leader, he controls what
legislation gets voted on by the Senate. Neither Tillis nor Coons sits on the Senate committees that introduced
legislation last year to lower drug prices through methods like capping price increases to the rate of inflation. Of the four
senators who drafted those bills, none received more than $76,000 from drug manufacturers in 2019. Tillis
and Coons spent much of last year working on significant legislation that would expand the range of items eligible to be patented — a change
that some experts say would make it easier for companies developing medical tests and treatments to own things that aren’t traditionally
inventions, like genetic code. They have not yet officially introduced a bill. As obscure as patents might seem in an era of public outrage over
drug prices, the
fact that drugmakers gave most to the lawmakers working to change the patent system
belies how important securing the exclusive right to market a drug, and keep competitors at bay, is to
their bottom line. “Pharma will fight to the death to preserve patent rights,” said Robin Feldman, a professor at
the UC Hastings College of the Law in San Francisco who is an expert in intellectual property rights and drug pricing. “Strong patent
rights are central to the games drug companies play to extend their monopolies and keep prices high.” Campaign contributions,
closely tracked by the Federal Election Commission, are among the few windows into how much money flows from the political groups of
drugmakers and other companies to the lawmakers and their campaigns. Private
companies generally give money to members of
Congress to encourage them to listen to the companies, typically through lobbyists, whose activities are
difficult to track. They may also communicate through so-called dark money groups, which are not required to report who gives them
money. Over the past 10 years, the pharmaceutical industry has spent about $233 million per year on
lobbying, according to a new study published in JAMA Internal Medicine. That is more than any other industry, including
the oil and gas industry. Why Patents Matter Developing and testing a new drug, and gaining approval from the Food and Drug
Administration, can take years and cost hundreds of millions of dollars. Drugmakers are generally granted a six- or seven-year exclusivity period
to recoup their investments. But drugmakers have found ways to extend that period of exclusivity, sometimes accumulating hundreds of
patents on the same drug and blocking competition for decades. One method is to patent many inventions beyond a drug’s active ingredient,
such as patenting the injection device that administers the drug. Keeping that arrangement intact, or expanding what can be patented, is where
lawmakers come in. Lawmakers Dig In Tillis’ home state of North Carolina is also home to three major research universities and, not
coincidentally, multiple drugmakers’ headquarters, factories and other facilities. From his swearing-in in 2015 to the end of 2018, Tillis received
about $160,000 from drugmakers based there or beyond. He almost matched that four-year total in 2019 alone, in the midst of a difficult
reelection campaign to be decided this fall. He has raised nearly $10 million for his campaign, with lobbyists among his biggest contributors,
according to OpenSecrets. Daniel Keylin, a spokesperson for Tillis, said Tillis and Coons, the subcommittee’s top Democrat, are working to
overhaul the country’s “antiquated intellectual property laws.” Keylin said the bipartisan effort protects the development and access to
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affordable, lifesaving medication for patients,” adding: “No contribution has any impact on how [Tillis] votes or legislates.” Tillis signaled his
openness to the drug industry early on. The day before being named chairman, he reintroduced a bill that would limit the options generic
drugmakers have to challenge allegedly invalid patents, effectively helping brand-name drugmakers protect their monopolies. Former Sen.
Orrin Hatch (R-Utah), whose warm relationship with the drug industry was well-known, had introduced the legislation, the Hatch-Waxman
Integrity Act, just days before his retirement in 2018. At his subcommittee’s first hearing, Tillis said the members would rely on testimony from
private businesses to guide them. He promised to hold hearings on patent eligibility standards and “reforms to the Patent Trial and Appeal
Board.” In practice, the Hatch-Waxman Integrity Act would require generics makers challenging another drugmaker’s patent to either take their
claim to the Patent Trial and Appeal Board, which acts as a sort of cheaper, faster quality check to catch bad patents, or file a lawsuit. A study
released last year found that, since Congress created the Patent Trial and Appeal Board in 2011, it has narrowed or overturned about 51% of
the drugmaker patents that generics makers have challenged. Feldman said the drug industry “went berserk” over the number of patents the
board changed and has been eager to limit use of the board as much as possible. Patent reviewers are often stretched thin and sometimes
make mistakes, said Aaron Kesselheim, a Harvard Medical School professor who is an expert in intellectual property rights and drug
development. Limiting the ways to challenge patents, as Tillis’ bill would, does not strengthen the patent system, he said. “You want
overlapping oversight for a system that is as important and fundamental as this system is,” he said. As promised, Tillis and Coons also spent
much of the year working on so-called Section 101 reform regarding what is eligible to be patented — “a very major change” that “would
overturn more than a century of Supreme Court law,” Feldman said. Sean Coit, Coons’ spokesperson, said lowering drug prices is one of the
senator’s top priorities and pointed to Coon’s support for legislation the pharmaceutical industry opposes. “One of the reasons Senator Coons
is leading efforts in Congress to fix our broken patent system is so that life-saving medicines can actually be developed and produced at
affordable prices for every American,” Coit wrote in an email, adding that “his work on Section 101 reform has brought together advocates
from across the spectrum, including academics and health experts.” In August, when much of Capitol Hill had emptied for summer recess, Tillis
and Coons held closed-door meetings to preview their legislation to stakeholders, including the Pharmaceutical Research and Manufacturers of
America, or PhRMA, the brand-name drug industry’s lobbying group. “We regularly engage with members of Congress in both parties to
advance practical policy solutions that will lower medicine costs for patients,” said Holly Campbell, a PhRMA spokesperson. Neither proposal
has received a public hearing. In the 30 days before Tillis and Coons were named leaders of the revived subcommittee, drug manufacturers
gave them $21,000 from their political action committees. In the 30 days following that first hearing, Tillis and Coons received $60,000. Among
their donors were PhRMA; the Biotechnology Innovation Organization, the biotech lobbying group; and five of the seven drugmakers whose
executives — as Tillis laid out a pharma-friendly agenda for his new subcommittee — were getting chewed out by senators in a different
hearing room over patent abuse. Cornyn Goes After Patent Abuse Richard Gonzalez, chief executive of AbbVie Inc., the company known for its
top-selling drug, Humira, had spent the morning sitting stone-faced before the Senate Finance Committee as, one after another, senators
excoriated him and six other executives of brand-name drug manufacturers over how they price their products. Cornyn brought up AbbVie’s
more than 130 patents on Humira. Hadn’t the company blocked its competition? Cornyn asked Gonzalez, who carefully explained how AbbVie’s
lawsuit against a generics competitor and subsequent licensing deal was not what he would describe as anti-competitive behavior. “I realize it
may not be popular,” Gonzalez said. “But I think it is a reasonable balance.” A minute later, Cornyn turned to Sen. Chuck Grassley (R-Iowa),
who, like Cornyn, was also a member of the revived intellectual property subcommittee. This is worth looking into with “our Judiciary
Committee authorities as well,” Cornyn said, effectively threatening legislation on patent abuse. The next day, Mylan, one of the largest
producers of generic drugs, gave Cornyn $5,000, FEC records show. The company had not donated to Cornyn in years. By midsummer, every
drug company that sent an executive to that hearing had given money to Cornyn, including AbbVie. Cornyn, who faces perhaps the most
difficult reelection fight of his career this fall, ranks No. 6 among members of Congress in drugmaker PAC contributions last year, KHN’s analysis
shows. He received about $104,000. Cornyn has received about $708,500 from drugmakers since 2007, KHN’s database shows. According to
OpenSecrets, he has raised more than $17 million for this year’s reelection campaign. Cornyn’s office declined to comment. On May 9, Cornyn
and Sen. Richard Blumenthal (D-Conn.) introduced the Affordable Prescriptions for Patients Act, which proposed to define two tactics used by
drug companies to make it easier for the Federal Trade Commission to prosecute them: “product-hopping,” when drugmakers withdraw older
versions of their drugs from the market to push patients toward newer, more expensive ones, and “patent-thicketing,” when drugmakers
amass a series of patents to drag out their exclusivity and slow rival generics makers, who must challenge those patents to enter the market
once the initial exclusivity ends. PhRMA opposed the bill. The next day, it gave Cornyn $1,000. Cornyn and Blumenthal’s bill would have been
“very tough on the techniques that pharmaceutical companies use to extend patent protections and to keep prices high,” Feldman said. “The
pharmaceutical industry lobbied tooth and nail against it,” she said. “And when the bill finally came out of
committee, the strongest provisions — the patent-thicketing provisions — had been stripped.” In the months after
the bill cleared committee and waited to be taken up by the Senate, Cornyn blamed Senate Democrats for blocking the bill while trying to
secure votes on legislation with more direct controls on drug prices. The Senate has not voted on the bill.
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Big pharma always wins – the link alone causes Congress to water down the aff so de
facto monopolies remain
Florko and Facher 19 [Nicholas Florko, Stat News Washington correspondent, and Lev Facher, Stat
News health and life sciences writer, 07-16-2019, “How pharma, under attack from all sides, keeps
winning in Washington,” Stat News, https://www.statnews.com/2019/07/16/pharma-stillwinning/]/Kankee
It does not seem to matter how angrily President Trump tweets, how pointedly House Speaker Nancy Pelosi lobs a critique, or how shrewdly
health secretary Alex Azar drafts a regulatory change. The
pharmaceutical industry is still winning in Washington. In the
makers and the army of lobbyists they employ pressured a Republican senator not to
push forward a bill that would have limited some of their intellectual property rights, according to lobbyists and
industry representatives. They managed to water down another before it was added to a legislative package aimed at lowering
health care costs. Lobbyists also convinced yet another GOP lawmaker — once bombastically opposed to the
industry’s patent tactics — to publicly commit to softening his own legislation on the topic, as STAT reported last
month. Even off Capitol Hill, they found a way to block perhaps the Trump administration’s most substantial anti-industry
accomplishment in the past two years: a rule that would have required drug companies to list their prices in
television ads. To pick their way through the policy minefield, drug makers have successfully deployed dozens of
lobbyists and devoted record-breaking sums to their federal advocacy efforts. But there is also a seemingly new
strategy in play: industry CEOs have targeted their campaign donations this year on a pair of vulnerable Republican
lawmakers — and then called on them not to upend the industry’s business model. In more than a dozen interviews
past month alone, drug
by STAT with an array of industry employees, Capitol Hill staff, lobbyists, policy analysts, and advocates for lower drug prices, however, an
unmistakable disconnect emerges. Even
though Washington has stepped up its rhetorical attacks on the industry,
and focused its policymaking efforts on reining in high drug prices, the pharmaceutical industry’s timehonored lobbying and advocacy strategies have kept both lawmakers and the Trump administration from landing any of their
prescription-drug punches. “Big Pharma has replaced Big Tobacco as the most powerful brute in the ranks of Washington
power brokers,” Sen. Dick Durbin (D-Ill.) said in a statement to STAT. Durbin, who recently saw the industry successfully oppose his proposal to
curtail some of the industry’s patent maneuvering, added that, “Pharma’s billions allow them to continue to rip off American families and
taxpayers.” The industry doesn’t get all the credit; it has also benefited from a fractured Congress and discord between President Trump’s most
senior health care advisers. PhRMA, the drug industry’s largest lobbying group here, declined to comment for this article. But industry leaders
have broadly argued against efforts to rein in the industry’s practices in terms of price hikes and patents, making the case that that could
irreparably stifle medical innovation. The battle is far from over, and industry representatives and lobbyists are quick to hypothesize that the
worst, for them, is yet to come. They point to several ongoing legislative initiatives, including in the Senate Finance Committee, that could take
more concerted direct aim at their pricing strategies in Medicare. They’re waiting, too, to see if House Democrats can cut a drug pricing deal
with the White House to empower Medicare to negotiate at least some drug prices. Another pending regulation, loathed by drug makers, might
tie their pricing decisions in Medicare to an index of international prices. They’ve also bemoaned the Trump administration’s decision last week
to abandon a policy change that would have ended drug rebates — which, the pharmaceutical industry has said, could have given drug makers
more space to lower their prices voluntarily. “We’re getting killed!” one pharma lobbyist told STAT. Of course, the Trump administration’s
supposedly devastating decision to abandon that proposal simply maintains the status quo. “Big Pharma has replaced Big Tobacco as the most
powerful brute in the ranks of Washington power brokers.” n Valentine’s Day, Sen. Thom Tillis (R-N.C.) enjoyed a showering of love that is
familiar in Washington: a flood of campaign contributions, many at the federal limit of $2,800 for a candidate or $5,000 for an affiliated political
committee. One donation came from Pfizer’s CEO, Albert Bourla, who donated $5,000 to Tillis and another $10,000 to Sen. John Cornyn (RTexas) and associated campaign committees. Another came from Kenneth Frazier, the top executive at Merck. The Tillis campaign committee
eventually cashed checks from CEOs and other high-ranking executives at those companies as well as Amgen, Eli Lilly, Sanofi, and Bristol MyersSquibb, plus two high-ranking officials at the advocacy group PhRMA. Six lobbyists at one firm that works with PhRMA, BGR, also combined to
contribute $100,000 to a bevy of Republican lawmakers and the party’s campaign arms. Tillis raised an additional $64,500 from drug industry
political action committees in the past quarter, according to disclosures released on Monday. A Pfizer spokeswoman declined to comment
about Bourla’s contributions, and representatives for the other companies did not respond to STAT’s request for comment. Tills was one of few
individual lawmakers — in many cases, the only one — to whom the executives had written personal checks during the current election cycle.
While drug industry CEOs frequently contribute to political committees for congressional leadership, the breadth of executives who donated
Tillis specifically is notable, particularly considering his outspoken role on pharmaceutical industry issues. While lobbyists pushed back on the
notion that campaign contributions directly influence votes, the donations targeted so specifically to a particular candidate could be seen as a
prime example of Washington’s system for rewarding loyalty and how industries protect their interests. The same PhRMA PAC that donated to
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Tillis has given generously in recent years: nearly $200,000 in the 2018 campaign cycle, roughly 58% of which was targeted toward Republicans.
Drug industry PACs donated $10.3 million in total in that cycle, according to the Center for Responsive Politics. The figure two years before was
even higher: a total of $12.2 million from industry-aligned PACs alone. It
is no accident that the pharmaceutical industry has
maintained its reputation among the nation’s most powerful lobbies, said Sheila Krumholz, the executive director of
the Center for Responsive Politics, an organization that tracks political influence. “Their access and influence goes beyond this
Congress or even the administration,” Krumholz said in an interview, adding that she “was struggling to think of
evidence” it had waned. Pharma has a reputation here for winning on policy — often thanks to the lawmakers
who are among the biggest recipients of the millions that drug corporations, employees, and the industry political
arms donate each year. Even as the rhetoric has escalated, the industry has quietly worked to insulate itself from any major legislative
changes. Take, for example, a recent about-face from Cornyn, the Texas Republican who took in some campaign cash alongside Tillis. As
recently as February, Cornyn seemed to be positioning himself as a rare Republican figurehead for anti-pharma
congressional wrath. At a widely publicized hearing before the Senate Finance Committee, he went head-to-head with AbbVie CEO
Richard Gonzalez, pressing him to explain why the company had filed more than 100 patents on its blockbuster arthritis drug Humira. Cornyn
introduced legislation soon after the skirmish to crack down on patent “thicketing,” a term for a drug company tactic to accumulate tens, if not
hundreds, of patents to shield a drug from potential generic competition. Pharma sprung into action. They recruited
congressional
allies, including Tillis, to pressure Cornyn to significantly rework the bill, and they succeeded. The version of the bill that
eventually cleared the Senate Judiciary Committee was stripped of language that would have empowered the Federal
Trade Commission to go after patent thicketing. Instead, the bill limited how many patents a drug maker could assert in a
patent lawsuit. The new version of the bill lost “a lot of teeth” and “solves a narrower problem in a narrow way,”
advocates told STAT when the change was first introduced. It is far from the only example of the industry’s aggressive
interventions to water down legislation. “In lots of ways they’re like the [National Rifle Association], because
they have an incredible power to squash out any negative opinion, nor to feel any of the ill effects of
those things,” said Pallavi Damani Kumar, an American University crisis communications professor who once worked in media relations for
drug manufacturers. “It just speaks to how incredibly savvy they are.” Pharmaceutical industry lobbyists also successfully fought to keep
another anti-drug industry patent proposal from Sen. Bill Cassidy (R-La.) and Dick Durbin (D-Ill.) out of a bipartisan drug pricing package moving
through the Senate HELP Committee. The legislation would have allowed the FDA to approve cheaper versions of drugs, even when the more
expensive product was protected by certain patents. Cassidy’s proposal never even made it into the HELP package. As the lobbyist who
bemoaned the withdrawal of the rebate rule put it, Cassidy “simmered down” in the face of industry pressure. In recent weeks, the industry
had targeted Cassidy in particular, in recent weeks, for fear he would break with many of his GOP colleagues to support a cap on some price
hikes for drugs purchased under Medicare, a proposal so far pushed only by Democrats. “Sen. Cassidy doesn’t care what lobbyists think — he is
going to do what’s best for patients,” said Ty Bofferding, a Cassidy spokesman. “Sen. Cassidy fought for the committee to include the REMEDY
Act in the package, despite strong opposition from the pharmaceutical industry.” The committee eventually included half the bill’s provisions,
he added, as well as four other pieces of legislation meant to prevent the industry from taking advantage of the patent system. The drug
industry also notched a win by watering down another proposal in that package from Sen. Susan Collins (R-Maine) that would have blocked
drug makers from suing over patents they didn’t disclose to the FDA. The version of the bill that actually made it into the package doesn’t block
drug makers from suing, but instead directs the FDA to create a public list of companies that fail to disclose their patents. “This change is a big
win for drug makers,” Michael Carrier, a Rutgers University professor and expert on patent gaming, told STAT. “Shaming is something drug
makers don’t seem worried about.” Matthew Lane, the executive director of the Coalition Against Patent Abuse, likewise added that the
altered bill “doesn’t seem to be doing much anymore.” Not all of the pharma-endorsed changes, however, are self-serving. Patent experts and
federal regulators too had raised concerns with some of the bill being proposed. Cornyn’s patent bill was particularly controversial. “These
provisions encourage ‘fishing expeditions’ by zealous bureaucrats, politically motivated by the popularity of efforts to reduce drug prices and
garner the political benefits of being seen to be pursuing these ends,” Kevin Noonan, a patent lawyer at McDonnell Boehnen Hulbert &
Berghoff wrote in a recent blog post, referring to the original Cornyn bill. Drug-pricing advocates said lobbyists have even managed to
convince lawmakers to introduce some legislation they say has explicitly favored the drug industry, including
intellectual property-focused legislation that would allow drug makers to patent human genes. That particular bill would “undo the
bipartisan effort underway to fix pharma’s exploitation of the patent system,” said the Coalition Against Patent Abuse. And they were far from
the only group raising concerns. The American Civil Liberties Union and more than 150 other groups wrote to lawmakers last month opposing
the bill. Pharma’s
list of policy victories goes on: Drug companies and allied patient groups forced the Trump
administration to back off a proposal to make relatively minor changes to Medicare’s so-called protected classes policy.
Currently, Medicare is required to cover all drugs for certain conditions, including depression and HIV. The Trump administration proposed in
November that private Medicare plans should be able to remove certain drugs in those classes from their formularies, if the drugs were just
new formulations of a cheaper, older version of the same drug, or when a drug spiked in price. But drug industry opposition helped convince
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the administration to spike that effort. A week ago, the industry struck its biggest blow yet. Three of the country’s largest pharmaceutical
companies —Amgen, Eli Lilly, and Merck — prevailed in a lawsuit to strike down a Trump administration requirement that they disclose list
prices in television advertisements. The lack
of congressional action — despite the Democratic enthusiasm and
bipartisan appetite — is still further evidence of industry’s ability to stave off defeat. As the dozens of Democrats
running for president ramp up their anti-pharma rhetoric, both Trump and progressives have begun to fret that Washington’s efforts
have proven to be all bark and no bite. With two weeks remaining before the August recess and an escalating 2020 campaign,
some advocates fear that the window for bold action is closing quickly. “It’s appalling that we are six months into this Congress and we haven’t
seen meaningful legislation passed on American’s number one issue for this congress,” said Peter Maybarduk, who leads drug-pricing initiatives
for the advocacy group Public Citizen. “Congress needs to get its act together.”
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Infrastructure boosts climate resilience and disaster relief, which stops widespread
structural violence
Flavelle 8-3 [Christopher Flavelle, reporter for The New York Times, focusing on global warming, 8-32021, "In the Infrastructure Bill, a Recognition: Climate Change Is a Crisis," NYT,
https://www.nytimes.com/2021/08/03/climate/infrastructure-bill-climate-preparation.html]/Kankee
The bipartisan infrastructure deal struck this week provides new money for climate resilience unmatched
in United States history: Tens of billions of dollars to protect against floods, reduce damage from wildfires,
develop new sources of drinking water in areas plagued by drought, and even relocate entire communities away from vulnerable places. But
the bill is remarkable for another reason. For the first time, both parties have acknowledged — by their actions, if not their words — that the
United States is unprepared for the worsening effects of climate change and requires an enormous and urgent infusion of money and
effort to get ready. “It’s difficult to oppose solutions to crises that your constituents are suffering through,” said Shalini Vajjhala, a former
Obama administration official who now advises cities on preparing for climate threats. And as those threats become more frequent and
widespread, “the constituency for climate resilience is now everybody.” When it comes to addressing the consequences of a warming planet,
no amount of money appears to be too much, and bipartisan consensus is easy to find. Agreement between
Republicans and Democrats to reduce the emissions that are causing the planet to warm is more elusive, as Republicans are largely resistant to
limiting the use of fossil fuels like oil, gas and coal. As a result, Democrats in Congress and the Biden administration are
aiming to
fold more aggressive climate action into a separate budget bill, which Democrats hope to pass even without
Republican votes. The infrastructure bill, which could pass the Senate this week, still faces uncertainty in the House, where progressives
oppose provisions to fund natural gas and nuclear plants, among other things. But money to protect communities from sea level rise and
extreme weather has few opponents. “The
climate crisis impacts both red states and blue states alike,” Senator Tom
Carper, Democrat of Delaware and chairman of the environment and public works committee, said in a statement. Many of his Republican
colleagues, he added, “have seen firsthand how calamitous the consequences can be if we fail to invest in
resilience.” The bill would also fundamentally transform the country’s approach to preparing for climate change. Until recently,
federal disaster policy has focused on spending money after a storm, wildfire or other calamity, to rebuild what
was lost. But a series of hugely destructive events — including Hurricanes Harvey, Irma and Maria in 2017, recordbreaking wildfires in California, this year’s winter storm in Texas and the drought now gripping the West
— has challenged that logic, demonstrating the need to better protect homes, neighborhoods and facilities before
disasters happen. The infrastructure bill reflects that change in different ways. Some of the money would supercharge
programs that already exist, but which experts say are not at the scale to meet the growing threat. For example, the Army
Corps of Engineers would get an additional $11.6 billion in construction funds for projects like flood control and river
dredging. That’s more than four times the amount Congress gave the Corps last year for construction. The
Federal Emergency Management Agency has its own program to reduce the damage from flooding, by buying or elevating
homes at risk from floods. That program would see its annual budget more than triple, to $700 million. Some of that
money is designated for homeowners in areas considered especially vulnerable because of socioeconomic factors, including being home to
racial minorities. FEMA has faced criticism for providing less money to Black disaster survivors than to white survivors, even when they suffer
similar losses. “That’s a game changer,” Rob Moore, a senior policy analyst at the Natural Resources Defense Council, said of the provision to
focus on vulnerable neighborhoods. FEMA would also get an extra $1 billion for a grant program to protect communities against all types of
disasters, and another $733 million to make dams safer. Other programs would see even more dramatic increases. The National
Oceanic
and Atmospheric Administration would get almost $100 million a year to help restore coastal habitats and protect
coastal communities — fives times what the program currently spends. The Bureau of Reclamation, which
manages water supplies in the West, now gets $20 million a year from Congress for desalination projects, which remove minerals and salts
from seawater to create fresh water, and another $65 million for water recycling. Those numbers would skyrocket: The bill includes $250
million for desalination over five years, and $1 billion on water recycling and reuse, the process of treating waste water
to make it available for new uses such as irrigation. Other funding in the legislation would be directed toward new programs. The bill
would give the Department of Agriculture $500 million for what it calls “wildfire defense grants to at-risk
communities” — money that could help people make changes to their homes or landscape, for example, to make them
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less vulnerable to fires. “It’s a great first step,” said Kimiko Barrett, a researcher and policy analyst at Headwaters Economics, a wildfire
policy consulting nonprofit in Montana. “We need to start looking at creating communities adapted to living with this increasing risk.” Other
programs would involve not just fortifying homes and facilities against disasters, but moving them out of harm’s way. The Department of
Transportation would get almost $9 billion for a program designed to help states prepare highways for the effects of climate change —
including relocating roads out of flood-prone areas. The Environmental Protection Agency would pay for communities to move drinking water
pipelines and treatment facilities at risk from flooding or other extreme weather. Funding in the legislation would be available to move
entire communities. The bill would provide $216 million to the Bureau of Indian Affairs for climate
resilience and adaptation for tribal nations, which have been disproportionately hurt by climate change. More
than half of that money, $130 million, would go toward “community relocation” — helping Indigenous Americans leave dangerous areas. “The
impacts and costs are so great, it’s just impossible to ignore anymore,” said Forbes Tompkins, who runs the floodprepared communities program at the Pew Charitable Trusts. “We might look back and say, this was the moment, this was the year, that made
resilience a national priority.”
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