The Politics of Patents
Jason Andrews
The Access GAP
2.4 Million people died of AIDS in sub Saharan
Africa in 2002 – yet only 50,000 in the region
had access to medicines for AIDS.
485,000 people died of AIDS in Asia in 2002 –
yet only 43,000 in the region had access to
medicines for AIDS.
(UNAIDS)
Treating AIDS in developing
countries is infeasible
► Africans
can’t take AIDS medicines because
they “don’t know what Western time is.”
--Andrew Natsios, chief of US Agency for
International Development under Bush
Myth #1: People living in developing countries
can’t adhere to difficult pill regimens
► Empirical
data from a wide range of resource-poor
settings show that people living in developing
countries can be as adherent, if not more, than
those living in developed countries
► Surveys in Botswana, Uganda, Senegal and South
Africa show 20% higher adherence rates than US
► Survey in Sao Paulo, Brazil found equivalent rates
to study in San Diego
Myth #2: It’s not the price of medicines, it’s the
lack of health infrastructure
True that health infrastructure in poor countries
may often be limited
 But no particularly complex/ expensive training or
infrastructure is required to run a successful
treatment program (Paul Farmer, Haiti)
 In all cases, the price of medicines is a key
component of treatment access

“There is a lot of talk here about 'forecasting
demand' for antiretrovirals in poor countries. We
should not forecast demand. The demand has
always been there. We should forecast our own
ability to stop ignoring demand."
--Paul Farmer
 Working in Haiti, Farmer and colleagues, working
in sparse electricity and without CD4 counts have
had better treatment results than most US clinics
Myth #3: Patents don’t affect access to
treatment
► Then
what happened in Brazil??
► In 1997, Brazilian government rolled out plan to
treat every AIDS patient
► To do so, they began producing generics in 1998,
and price of medicines has fallen by an average of
79%
Success in Brazil
► Brazil
has already cut its AIDS death rate by 50%
► Has half the number of HIV cases that World Bank
projected in 1994
► AIDS patients are a quarter as likely to be
hospitalized as before
► TB incidence has fallen by half
► Health Ministry spent $444 million on AIDS drugs
in 2000
► Decline in hospitalizations alone saved Health
Ministry $422 million from ’97 to ’99
Generics, anyone?
Not if we (and by “we” I mean
“U.S.”) can help it
Costs of Major AIDS Drugs
► Large
disparity between price and production
costs provides big incentives for generics to enter
market
So what’s to keep countries from
producing generic versions of AIDS
drugs?
►
►
►
U.S. patents don’t prohibit generic production in other
countries
U.S. pharm companies must file patent in every country in
which they wish to protect their drug from generic
production
But who is to keep developing countries from violating the
patents and producing generics??
The World Trade Organization
► The
WTO signed the Trade-Related Aspects
of Intellectual Property Rights Agreement
(TRIPS)
► Sets minimum standards for protection of
intellectual property by its members
► Member countries will be required to
respect foreign patents filed in their country,
not produce generics without permission
from the pharm companies
► Goes into effect in 2006, 2016 for least
developed countries (LDCs)
Some good news….
► TRIPS
does have a provision in it that allows
countries to produce generic drugs for public
health crises
► However, no country has done this, largely out of
fear of being put on “trade watch list” by US which
would greatly decrease foreign investment and
severely hurt their economies
► Developing countries wanted the language of this
provision clarified and strengthened to protect
them
► In
months leading up to meeting of WTO
ministerial meeting, the U.S. lobbied heavily
against provisions that enabled generic
production in public health crises
Disaster Strikes… and the U.S. takes
a new look on compulsory licenses
► One
month before the WTO ministerial
meeting to address the questions raised
about compulsory licensing in TRIPS,
Anthrax hits the U.S.
► As a result, the U.S. threatens to violate the
patent on Cipro unless the German
manufacturer made enough doses available
at a lowered price
A Victory for the Developing World
► One
month later, at the WTO ministerial
round in Doha, a resolution was passed
stating that the TRIPS agreement should be
interpreted in a way such as to “protect
public health and, in particular, to promote
the access to medicines for all”
The Empire Strikes Back
► With
the Doha Declaration providing a
means for developing countries to produce
generics when public health crises emerge,
the U.S. sought other ways of protecting
their pharm companies
► They began signing bilateral trade
agreements with more strict rules
prohibiting generic production (TRIPS+)
And those without the means
► What
about smaller/poorer countries
without the capacity for generic production?
► The TRIPS agreement is unclear on whether
the countries will be able to import generic
medicines from other countries
► Again, most countries are too afraid of U.S.
trade sanctions to import generics
Why all of this?
The Short Answer
► Follow
the $
► The Pharm industry, the biggest Washington
lobbiest and largest donor to political
campaigns, put pressure on the U.S.
government to protect their interests
through the WTO
Pharm Guide to dropping $150M
►
►
►
►
►
“The documents show that the trade association, the
Pharmaceutical Research and Manufacturers of America, known
as PhRMA, will spend at least $150 million in the coming year.”
“The drug trade group plans to spend $1 million for an
"intellectual echo chamber of economists”--a standing network
of economists and thought leaders to speak against federal
price control regulations through articles and testimony, and to
serve as a rapid response team.“
“At least $2 million, and perhaps $2.5 million, in payments to
research and policy organizations, "to build intellectual capital
and generate a higher volume of messages from credible
sources" sympathetic to the industry.”
“In addition, the budget sets aside $17.5 million to fight price
controls and protect patent rights in foreign countries and in
trade negotiations.”
“$9.4 million for public relations, including "$1 million for
inside-the-Beltway advertising, $555,000 for placement of opeds and articles by third parties," $600,000 for polling, $1.3
million for local publicity in 15 states and $680,000 for media
relations consultants.”
yes, there are some actual
arguments for patent
protection too
The Money Argument
► Pharm
companies need money for R&D,
can’t just give drugs away
Who pays?
Blackmarkets?
► Allowing
developing countries to produce
cheap, generic versions of drugs used in
developed countries will lead to a massive
black market that will undermine markets in
developing countries
► As
part of an agreement to allow generic
production of a drug, developed countries
could require that countries take significant
measures to prevent illegal export of the
drugs
► Pills could be made a different
color/appearance to make detection of
generics easier
What they don’t know… fills our
pockets
► Pharmaceutical
companies are worried that
if generics are produced in developing
countries, people in the developed countries
will learn how low the cost of their
production is tarnishing the companies’
images
Sounds good to me
When all else fails, sue ‘em
Pharm v. South African Government
► In
1998, a group of 39 pharmaceutical
companies filed a lawsuit challenging a 1997
law that enabled South Africa to issue
compulsory licenses for production or
importation of generic essential medicines
► The Clinton Administration (and, most
notably, Al Gore) supported the Pharm suit
Talkin’ bout a revolution
► The
South African
Treatment Action
Campaign lead
thousands of
activists and HIV+
South Africans in
protest of the
pharmaceutical
companies
We’re outta here
► On
April 19, 2001, the Pharm companies,
not enjoying the negative publicity they
were getting from filing a suit aimed at
preventing life-saving drugs from being
imported to the country with the most
people suffering from AIDS dropped the suit
They may have won the battle….
 The
U.S. continues to negotiate bilateral
trade agreements, which threaten the
abilities of countries to retain the right to
generic production
 As of yet, no country has issued a
compulsory license, indicating that despite
the WTO provision, most countries are still
afraid to anger the U.S. Trade
Representative
Campaigns
► Doctors
Without Borders initiated a large scale
Access to Essential Medicines Campaign:
http://www.accessmed-msf.org/
► Student campaign for changing university policies
to promote access to essential medicines
developed at universities (started at Yale):
www.essentialmedicines.org
► Consumer Watchdog Organization with lots of
information on intellectual property and health:
www.cptech.org
the end