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Ethical Market: Ethnographic Encounter with CML Patients, and Glivec in Global
South Korea
Eunjeong Ma
Color house 204-301, 305-3 Pungnap 2-dong
Songpa-gu, Seoul 138-875
South Korea
E-Mail: eunjma@gmail.com
Abstract: This paper discusses the demand on the shaping of ‘ethical market,’ into which
the desires and despairs of the biomedically afflicted populations are captured to establish
the terms and conditions of getting access to an innovative prescription drug. Two
premises are set: the size of afflicted population is relatively small that can be ; and yet,
the consumption of the drug can alter the course of the illness from fatal to chronic
condition as well as the lifestyle from bare to new life. More importantly, these premises
should be met with the global trade order. Under the circumstances, patients mobilized all
political and social means to politicize the global order embedded in intellectual property
rights, bio-innovative drugs, and drug pricing policies, rather than passively waiting for
international and national regulatory arrangements to be resolved. And they made a
strategic alliance with physicians, pharmacists, and social activists to create the political
and moral space in which they speak for their rights as legitimate, global citizens rather
than as deprived species. This strategic space is spoken in the languages of responsibility
and morality through the drug, whether an innovative or a copy drug, can be traded.
Because of the recent explosion of powerful molecular technology in cancer research,
scientists are searching intensively to discover the correct targets in cancers. These
innovative drugs are exorbitantly priced for the costs of research and development spent.
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The governments around the world are keen to developing cheap general drugs, which
helps to lower the costs of public health expenditures. Many developing countries
including Brazil, South Africa, and Thailand implemented compulsory licensing to
accelerate access to a drug that was under patent protection, in order to parallel import
generics of ADIS treatments from India, for example.
In the early 2000s, Korea Non-Governmental Organizations (NGOs) were
engaged in drug pricing negotiations over Gleevec/Glivec1 with its manufacturer
Novartis, a multinational pharmaceutical company. Since its efforts to get into the entry
of the global market, Novartis, the patent holder with the exclusive right to market a
molecular targeted anti-cancer drug, was faced with a series of legal challenges in the
processes of putting the pharmaceutical on the market. Glivec, an anti-cancer drug, was
marketed by Novartis at a very high price. The NGOs pleaded with Novartis to market
the drug at a more affordable price to Koreans in consideration of local economic
situations, rather than applying a universal price. When they failed to persuade Novartis
to lower the price, they resorted to an alternative tactic. NGOs and patients raised some
fundamental questions regarding public health policies and the role of the state in this era
of globalization, and made the Glivec case “controversial” and creating room for
“dissensus” as a way of participating in the policy-making process.
Diverse social and public health activists groups raised the common concern
about the fundamental, constitutional right to the pursuit of happiness, that is, the right to
access drugs. The heterogeneous network of social actors merged on a website, which
was created by a progressive social activists group, in order to raise social and political
awareness surrounding intellectual property rights and their unruliness as tools and
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standards of global governance. When the government’s interests are not directly
compatible with either of local NGOs or of the pharmaceutical company, Korea NGOs
made an interesting discursive turn from the fight against the gigantic international
cooperate to security of local citizenship regarding access to essential medicines. In the
process, they defined and rearticulated biological citizenship (Petryna 2005; Rose &
Novas 2005)2 in ways in which local economic, legal, and political circumvents are
accounted to embody the potential global connections. Instead of deferring to imposed
superciliousness of global governing technologies, they insisted that the dominant policy
paradigms take into account local and national conditions. This resulted in a blurring of
the boundaries between the governing and the governed. In addition, they tried to
establish epistemic networks with nations that shared common interests and concerns.3
The paper is based on documentary analysis, drawing on extensive news coverage,
magazine articles, and policy analysis reports issued by non-governmental organizations.
I also conducted in-depth interviews with patients, activists, doctors, policy makers, and
people with the pharmaceutical industry. I also visited a Bone Marrow Transplant ward in
a major teaching hospital in downtown Seoul, Korea for three months, to interact with
patients and their families.
Drawing on the notions of ‘therapeutic mobilization’ and ‘therapeutic
citizenship,’ my work extends to bring non-quantifiable properties into the dimensions of
the makeup of the markets. “AIDS activists established AIDS as a problem of social
justice and demanded that the state fulfil its constitutionally mandated biopolitical
obligations. They made their biographies public, carried out prevention and assistance
work, and moved from micro- to macro-interventions” (Biehl 2007: 59). Biehl further
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notes that the political activism played out by patients is “one of self-identification, and it
involves a new economics of survival. Desires are fundamental to life chances, unfolding
in tandem with a state that is pharmaceutically present (via markets) but by and large
institutionally absent” (Bihel 2007: 285, emphasis is mine). Not to mention that
transnational humanitarian organizations such as MSF played a significant role to
facilitate the actions of the governments, it is equally, if not more, true that grassroots on
the part of the afflicted fiercely fought for their rights. Biehl (2008: 1107) acutely
examines the pharmaceuticalization of public health, in which medicines have become
increasingly equated with health care for afflicted populations. As pointedly observed in
the cases of AIDS, pharmaceutical companies operate astutely within legal and regulatory
windows of opportunity with the subtle and strategic mobilization of marketing tactics
and redirecting activist and political gains to their own advantage. The ever-increased
presence of pharmaceutical companies especially in the realm of public health or the
corporate colonization of medicines (Boggs 2005) often leads to international trade
conflicts between local governments, civic organizations, and pharmaceutical companies
over the issues of national sovereignty, constitutional rights, and intellectual property
rights. Neoliberal global markets have enabled the circulation of political ideologies,
social activism, and material goods at an accelerated, if not concurrent, level.
Novartis, Glivec/Gliveec, and Corporate Citizenship
The development of Glivec has provided a breakthrough for two rare yet lifethreatening cancers: chronic myeloid leukaemia (affecting 1 in 100,000 of the population:
2500CML patients in Korea) and gastrointestinal stromal tumor. Glivec is a new orally
administered treatment for patients in any one of the three stages of chronic myeloid
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leukemia (CML blast crisis, accelerated phase, chronic phase). CML is known to result
from chromosome translocation. Glivec, unlike chemotherapy and interferon, was
designed to attack only the cancer cells without doing harm to normal cells by inhibiting
translocation.4 The hematologic and cytogenetic responses are significantly better than
conventional interferon alfa plus cytarabine treatment, not to mention the fact that
magnificently improved quality of life. Similarly, prior to Glivec, the only solution for
GIST was surgery. The improved response rates with Glivec in CML and GIST are
durable and translated into prolonged survival.
Multinational corporations have taken innovative and subtle marketing strategies
under the banner of corporate responsibility, with impressions that they take full
responsibility of providing better quality of life to the people in need. As such, many of
transnational pharmaceutical companies, including Novartis, have set up programs to
offer drugs to the poorer in developing countries, for instance. Novartis Oncology
initiated a global, long-term patient access plan, which consisted of an accelerated
clinical development program, a global Expanded Access Plan to reach patients not
enrolled in clinical trials, and after approval of Glivec in 2001, the Glivec International
Patient Assistance Program (GIPAP) to provide Glivec at no cost to patients in
developing countries who could otherwise not afford treatment. Novartis distinguishes its
GIPAP from other charity organization, in that it operates within the existing national
healthcare system in a supplementary way rather than replacing it. To operationalize the
program, Novartis works in partnership with the Max Foundation, a US-based non-profit
patient organization specialized in CML, which reviews patient applications based on
medical and financial requirements. The targeted recipients of the program are the
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underserved/underprivileged in developing countries without necessary healthcare
benefits. And yet it has been true that online support groups have played a key role to
enrol leukaemia patients worldwide in the program, informing patients of the latest
development of treatments and affordable access to them, in addition to sharing and
offering emotional support. Patients support groups mediated though the Internet, in fact,
can help the information about the disease and its treatments flow from advanced
countries to semi-developed or developing countries (Rai-Chadhuri and Hogan 2004). As
of 2006, Novartis is helping patients in 81 countries in Asia, Latin America, and Africa,
including India, the Philippines, and Thailand, and has provided treatment at no cost to
14,500 patients (Lassarat and Jootar 2006). Despite the goodwill of the program, the
concern still remains that there may be left out of service, especially those afflicted
populations in rural and remote villages with no access to appropriate healthcare systems
and even the Internet.
In examining Novartis’s marketing strategies under the umbrella of corporate
citizenship vis-à-vis health activists’ anti-corporatism in India, Ecks (2008) points outs
that Novartis’ global corporate citizenship program succeeded in protecting its profits in
Euro-American markets. While the Indian case with Novartis was to do with legal battles
over the interpretation of novelty in granting patent rights to new pharmaceutical
products, the relation between Novartis and locales was unfolded differently in other part
of Asian countries. In the South Korean case, health activists, who were becoming and
emerging over the course of fight against transnational corporatism, adopted/mimicked
the tactics and repertoires of social and political activism. Under the circumstance in
which they found the lack of the government’s strong will to protect its citizens’ interests
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as opposed to the pharmaceutical company’s aggressive marketing, they had to politicize
the incumbent situation by identifying the pharmaceutical corporation with an alien
monster with innate brutal, merciless characters. Similarly Adriana Petryna (2002) and
Nikolas Rose (2006) delineate the development of “biological citizenship” to capture
welfare claims made by the biologically afflicted populations within the constraints of
legal and scientific criteria in times of neoliberal reform. With a focus on civic
organizations’ activities to enroll local patients with AIDS in Africa, Vinh-Kim Nguyen
(2004) introduced “therapeutic citizenship” to highlight patients’ claims and ethical
projects to global organizations, whereas Stefan Ecks (2008) coins “pharmaceutical
citizenship” to ask about the relations between life-saving drugs and legal, political, and
social rights.
When it was first introduced to patients with leukemia in Korea, it was hailed as a
‘miracle’ or ‘wonder’ drug, just as it was in the United States.5 Even before the United
States Food and Drug Administration (USFDA) approved Gleevec, it had already been
approved by the Korea Food and Drug Administration (KFDA) in April of 2001 under
the orphan drug plan for patients with leukemia, on condition that the drug would go
through the third phase of clinical testing. The news media presented it as an
‘unprecedented’ event with no parallel in Korean history, since no foreign-made drugs
had ever been approved in Korea before they had been approved by the USFDA and this
before the drug had even gone through the third stage of clinical testing in South Korea.
In response to this swift action, Novartis, the patent holder, under its Expanded Access
Program (EAP),6 provided Glivec capsules to CML patients in Korea free of charge with
the permission of the KFDA. About 75 out of 150 patients who were administered
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Gleevec were reported to have improved symptoms. Almost immediately, it was reported
in the media to be a ‘miraculous anti-cancer drug’ and stories of patients who felt much
better after treatment7 were presented. However, when the trial period of the free drug
was over and negotiations over the price between the Korean government and Novartis
had been locked in a stalemate for almost two years, what was once known as a miracle
drug turned into a dasher of hopes and dreams.8 When the initial conflict over the price of
Glivec emerged, Novartis responded with discontinuing to the supply of Glivec to the
patients for about two weeks from November 27 to December 9.
Ecks suspects that Novartis’ international patients support programmes (eg. Max
Foundation), especially ‘giving away the drug for free to those in need in developing
countries’ are aimed to protect its image of a “good citizen” in Europe and North
America and to maintain the high price level in European and North American markets
(Ecks 2008: 177). In a similar context, Nikolas Rose (2006: 142) argues that
pharmaceutical companies sponsor patient support groups to keep in good standing with
the public and to advertise its products, and . In the case of Novartis, patient support
groups sponsored by the company became vital to advertise the drug and to promote the
benevolent image of the company.
Before the USFDA approved Glivec, the South Korean government recognized
Glivec under the category of Orphan Drug to expedite access to the investigational drug.
In response to this swift governmental action, in April 2001 Novartis provided Glivec
capsules for free of charge to the Korean leukemia patients under Expanded Access
Program through which a trial drug before governmental approval can be available to the
afflicted populations. Between April 2001 and February 2003, Novartis dispensed Glivec
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capsules estimated to cost 150billion KRW to 460 patients in total. More notably, when
the South Korean government set the price for Glivec in 2003, Novartis has made a
benevolent gesture that it would shoulder 10% of the patient’s share (Maag and Bae
2006: 162). In fact, Korean patients, like those patients in other developing countries such
as Thailand and the Philippines, take the drug de facto free of charge, about which
Korean patients do not agree. Rather than taking the offer of Novartis as standing for
good corporate practices marketed in the rhetoric of caring and curing, Korean patients
believe that their fierce activism brought the change in the corporate behavior and that
they have earned it.
South Korea Pharmaceutical Market and “Glivec Solidarity”
Big pharmaceutical companies have turned into the market for the treatments of
rare diseases, making up 70% of a market share of the area along with 43% ownership of
approved orphan drugs in 2009.9 It is forecasted that Asia will be a major market in need
of such innovative drugs for rare diseases because of less developed or the lack of the
pharmaceutical infrastructures. Part of the reason why big pharmaceutical companies like
GSK and Pfizer turn to rare diseases is to do with the diversification of marketing
strategies under the pressing situation in which their pipelines of innovations drugs are
depleted. Regulatory constraints are a bit loose to boost the development of treatments for
rare diseases with respect to relatively smaller scale of clinical trials, tax exemptions, and
expedited approval process. The South Korean pharmaceutical market is estimated to be
approximately US$10 billion, making it the 11th or 12th largest in the world. In Asia, it is
placed the third after Japan and Australia, according to Business Monitor International’s.
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The key drivers behind the market’s rapid nine-percent growth are high per capita
consumption, and a rapidly increasing aging population, among others.
Unlike recurring social and political activities in Korea, the Gleevec case at its
inception was not shaped by a well-structured, self-identified civic organization.10 In
almost every respect, beyond a small, insulated circle of interested parties such as
patients, physicians, and their relatives, it was an issue invisible to the public. It may be
said that the case per se has co-evolved with the growth of the civic organizations
involved to such an extent that a union of organizations with common interests and
identity has formed as the case has developed. In other words, neither interested groups
nor non-governmental organizations with the power of drawing ever more new members
have steered the Glivec movement. Rather, a patients’ support group named “New Light
Over the World” (Saebit Nuri in Korean),11 which was founded in 1995, has taken the
lead and extended its network in cooperation with the Internet-based activist group called
the “Korean Progressive Network”(hereafter the Jinbo Network)12 and used the Internet
strategically as a medium, not only for facilitating communication among the patients but
also for publicizing their activities to a wider audience.
CML patients in Korea learned about the new cancer drug through the Internet in
December of 2000. Six months later, in June of 2001, Novartis filed with the Ministry of
Health and Welfare (MOHW) in Korea to register Glivec as a medicine eligible for
national health insurance coverage for 25,000 won per capsule in Korean currency (US
$20), which was much higher than the 17,826 won (US $14.2) that the Korean
government had proposed. This worked out at an estimated cost of three to six million
won per month for each patient. The suggested price, unless covered by insurers, was
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considered too high for those patients who had to take four to eight pills a day. Under the
current National Medical Insurance (NMI) system, patients shoulder 30% of the price. No
sooner did the patients become aware of the market price of the drug, than they petitioned
both Novartis and the MOHW to take account of patients’ economic situations and to
lower the price to a more affordable and reasonable level of around 17,000 won.
By a series of online activities, a common objective among the participants began
to be clearly formulated: (Korean) patients’ lives versus the profits of multinational
pharmaceutical companies armed with intellectual property rights.13 While these onlinebased activities are said to have helped unite the people directly concerned, offline
activities were needed to get the attention of the mainstream media and to appeal to a
wider public.
When the news broke in June 2001 that price negotiations between the
government and Novartis had collapsed, more NGOs began to join. The Korean
Pharmacists for Democratic Society (KPDS)14 and the Association of Physicians for
Humanism (APH)15 formed an alliance with the patients’ support group and the Jinbo
Network to solve the Glivec problem: they demanded that Novartis lower the price to one
that is affordable. They rebuked Novartis for trying to maintain a universal
pharmaceutical price in all countries. Simultaneously, by holding street demonstrations
and sit-ins in front of government and Novartis buildings they attempted to pressure the
government to include Glivec in the insurance scheme of national healthcare. However,
when the government announced that patients in the second and final stages of leukemia,
but not those in the first stage, would be partially covered, the NGOs intensified their
street demonstrations against the drug pricing policy, requesting that the government
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review patent rights, and to consider the possibility of granting a compulsory license and
expanding insurance coverage to all leukemia patients.16 Furthermore, they threatened to
import a copy of Glivec from India, where copyrights are not granted to pharmaceutical
products, at a price as low as 5% of Novartis’ suggested price.17 At that moment, about
ten civic organizations were allied, including the Korean Federation of Activists Fighting
for Health Rights, Intellectual Property left (IP let), People’s Health Coalition for an
Equitable Society, and People’s Solidarity for Social Progress. 18 In December of 2001,
they formed a task-oriented union of NGOs known as the “Solidarity for the Resolution
of the Glivec Problem and for Securing Fair and Equitable Access to Pharmaceutical
Products.”19 As the names of the NGOs suggest, the Solidarity was mainly composed of
physicians, pharmacists, patients, social activists, and patients’ advocacy groups. It was
unusual that such diverse social groups should work together to ensure the public’s
access to medicine. In January 2002, on behalf of the Solidarity, IPleft requested the
compulsory licensing of Glivec to be manufactured by others than Novartis. They based
their claim on a legislative clause of the Korea Patent Law stipulating that “copyright
could be used by the government or by third parties without the authorization of the right
holder in the case of a national emergency or in cases of public non-commercial use” (the
Korean Patent Law, clause 107 (i) (iii)).20The NGOs, especially, pointed to the clause
“public non-commercial use,” which was added to the Korean Patent Law of 1995 in
order to comply with the TRIPs agreement. Although member countries had differed on
the grounds or conditions on when to grant compulsory licensing, the articles of TRIPs
agreement (31b and 31c) state that compulsory licensing could be applied in cases of
national emergency or public non-commercial uses. This was reinstated in the WTO
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Doha Declaration adopted in 2001, Declaration on the Trips Agreement and Public
Health, by enumerating circumstances under which the agreement “does not and shall not
prevent” each country from taking independent measures to protect its own public health.
Concurrently, the Solidarity held a public discussion on such issues as relations between
the WTO and copyrights, (barriers to) accessibility to medicine in developing countries,
and successful cases of the use of the compulsory license in developing countries.21 By
comparing cases over drugs for AIDS in Brazil, Thailand and South Africa with what
was happening in Korea, they emphasized that big pharmaceutical companies had
overused intellectual property rights to gain profits from new drugs in developing
countries against the public interest. The NGOs tried to show that intellectual property
rights had been abused or overused by the developed countries, especially by the US
which strove to protect its interests in Brazil, Thailand, and South Africa by exerting
pressure to either revise the patent law or to change drug pricing policies. By comparing
policies, the NGOs hoped to make the point that each nation has the right to establish
pharmaceutical prices suitable to its local conditions and whose processes were not to be
infringed upon by pressure from the PhRMA (Pharmaceutical Research and
Manufactures of America). Beyond that, the NGOs envisioned building a global network
with organizations in all developing countries.22 All of these activities were documented
in the MS Word format and posted onto the website immediately.23 By this time, the
main focus of the Glivec case shifted from access to Glivec to access to medicines in
general, exemplifying the unavoidable conflict between national sovereignty and the
ruthless and predatory nature of international trade. They contended in the Petition for a
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Compulsory License submitted to the Korean Patent Office representing the government,
24
“If drug pricing policy is a part of individual sovereign nation’s public health policy,
the price of a drug should be determined at a level the patients of the sovereign nation
can afford and access.” (Nam, HeeSeob, 2002:15)
The Korean government also has a duty to establish a comprehensive and
systematic health policy for the benefit of its people, and should consider the peculiarities
of Korea rather than base its policies on universal criteria that are applied to all other
nations. In this regard, the single, universal price policy of Novartis, the patent holder, is
in interference with the South Korean government’s autonomous decision-making
procedures in which citizens’ economic situations and accessibility to medicine are taken
into account. Novartis, however, maintained that the Korean case did not qualify for the
exception rule of the WTO and infringed on its exclusive patent right.25 Over the course
of the price negotiations, Novartis was adamant about maintaining a single price across
the globe. Rather than lowering the price, Novartis even proposed to reimburse patients
30% of the insurance cost if the government accepted the price Novartis offered. In
response, the NGOs pointed to the clause in the WTO agreement, specifying that an
individual nation has the freedom to determine what constitutes public interest and
national emergency. Novartis insisted that the number of CML patients effected26 was so
small that the situation could not possibly be considered as a national emergency or that
their actions were inimical to the general public’s interest. However, the extent and
degree of individual patients’ (and families’) suffering should be taken into consideration
when determining what constitutes the public’s interest, given that CML patients are
practically unemployable and that additional expenses are incurred by them.
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In July of 2002, in the middle of the Glivec debate, the outgoing first minister of
the Ministry of Health and Welfare (MOHW) told the press that he was forced to resign
because of aggressive lobbying and pressure from the multinational pharmaceutical
companies. He attributed to them his failed attempt to reform drug pricing policy through
a plan that should have been implemented in August of 2001. He contended that the plan
could not be enforced because of the concern that its enforcement could develop into a
trade dispute with Western countries. The news media spotlighted the incident everyday
by relating it to the pervasive penetration of the PhRMA into the Korean market. In July,
since it was reported that representatives of the PhRMA had tried to pressure the Korean
government into participating in the process of setting pharmaceutical prices,27 public
sentiment turned bitter and they demanded that the government hold a national assembly
to investigate foreign intervention into policy-making processes. During deliberation, a
representative of the MOHW committee revealed to the public a letter from Donald L.
Evans, U.S. Secretary of Commerce, postmarked 2 July, 2001, in which he wrote:
‘We [Americans] are concerned about the discriminatory effect the proposed changes
[reference pricing system] to the pharmaceutical pricing system would have upon our
products. If not addressed appropriately, this issue is likely to develop into a serious
trade dispute…. The South Korean government consults fully and substantially with
interested parties, including foreign research-based pharmaceutical manufactures, as
well as with our government before making its final decision.’ (Quoted in Han Kye Re
21. 2002)28
The new plan was expected to stabilize the health insurance system by containing
medical cost inflation. Under the new plan, prices of ‘brand’ drugs would be compared
with those of locally produced generic medications with a similar efficacy. The Health
Insurance Review Agency (HIRA) would then cap the prices at a level between those of
the originals and the generics. Patients would pay a proportion of the price of drugs
within the same therapeutic category even if physicians prescribed the expensive brand15
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name drugs. Thus, the government attempted to contain medical cost inflation and to
lessen the burden of patients. Indeed, the Glivec case reflects the larger changes in public
health related matters in Korea, particularly drug-pricing policy.
Drug-Pricing Policy in Korea
PhRMA is persistent to contend that intellectual property protection is a key to
building a strong, dynamic and innovative pharmaceutical sector, helping to translate new
innovations and discoveries into products. As part of its effort, in February 2009, PhRMA
filed its Special 301 submission supporting its global intellectual property priorities. The
Special 301 process is an important part of the U.S. government’s efforts to strengthen
intellectual property laws and enforcement around the world. PhRMA’s Special 301
submission identified specific countries that need to improve their intellectual property
protection and enforcement efforts for pharmaceutical and biotechnology products. It also
identifies market access barriers and counterfeit drugs (PhRMA 2009).
The Trade Related Aspects of Intellectual Property Rights (TRIPS) was
established on 1 January 1995, with a stronger and more harmonious grip on the
protection of intellectual property rights. Many developing countries, including South
Korea aligned national patent laws to comply with the regulatory arrangements of TRIPS,
starting with the acknowledgement of product patent rights in 1987. Like India, the
Korean pharmaceutical industry relied on copy drug or generics rather than investing in
developing innovative drugs. With the implementation of TRIPS, the global standards are
set to enforce 20 years of exclusive rights to a patented product from filing, although the
effective term may be much shorter with exclusive marketing protection (Grubb 2004).
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A domestic pharmaceutical had been undergoing drastic changes due to a few
national and international regulatory shifts. First, as a member nation of the WTO, the
Korean government had to set up legal measures to strengthen the protection of
intellectual property rights in pharmaceuticals. Due to the increasing pressure from the
US government, the Korean government had taken measures to strengthen the protection
of intellectual property rights in pharmaceuticals by revising the Korea Patent Laws. It
was in 1987 when the government endorsed product patents in the laws, as a way to
protect innovative pharmaceutical products from the encroachment and infringement of
property rights by domestic pharmaceutical companies. Like other developing countries,
the local pharmaceutical industry was heavily relied on copy drugs or generics rather than
investing in developing innovative drugs.
Second, since August 1999, foreign pharmaceutical companies have registered
medicines with the government-controlled price list in order to be reimbursed under the
system of Nationalized Medical Insurance (NMI) in Korea. Before 1999, foreign
companies had to market drugs directly to hospitals and doctors at much higher prices
than domestic products. In order to gain a bigger slice of the market, domestic
pharmaceutical companies gave rebates to hospitals in return for them purchasing their
products. Unhappy with these transaction practices, foreign companies pressured the
Korean government to include their products within NMI coverage.29 However, when
foreign pharmaceuticals were incorporated into the NMI in 1999, multinational
pharmaceutical companies, including Novartis Korea Ltd, strongly resisted accepting the
government’s suggested pricing systems and wanted their expected prices to be projected
into the NMI system on the grounds that they did not reflect market prices.
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In case of Glivec, Novartis claimed that the suggested prices were only 77% of
the market prices.30 As a member of OECD, Korea should negotiate the international
trade order which asks Korea to follow ‘A7 pricing’, which refers to the new drug pricing
system when it comes to ‘innovate drugs’ marketed by the PhRMA. A newly made drug
is priced in accordance with the ex-factory average price of A7 advanced nations, which
includes the United States, the United Kingdom, France, Italy and Japan. Given that the
majority of all innovative drugs come from the research-based multinational
pharmaceuticals, the clash between the local governments and big pharmaceutical
companies over a drug price might be inevitable in the first place.
Third, since the implementation of NMI, the insurance agency in charge of NMI
has been suffering from a budget deficit, and thereby the government tried to lower the
costs of drugs to balance out the system. In 2001, the South Korean government
implemented the professional division of labor between pharmacists and physicians,
which involved the division of the pharmaceutical market between prescription drugs and
generics. Complaints piled up from multinational pharmaceutical companies that “Over
the last two years after introducing the separation of subscription and dispensing, the
government has focused on lowering the rising prices of medicines” to cut the budget, 31
but it did not consider the cost of investment, as the chairman of the Korea Researchbased Pharmaceutical Industry Association (KRPIA) and president of Pharmacia Korea,
Jan Petersen said in an interview with The Korea Times.
Empowered citizenship
Innovative and life-saving drugs not only change the history of illness, they also
drastically affect the meanings of life and lifestyles. AIDS, once known as an incurable
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and fatal disease, is recognized to be more like a chronic yet manageable disease as long
as properly treated and medicated. Thus, access to medications and treatments becomes a
pivotal issue to the matter of life or death. As patients collectively recalled, the securing
of and keeping up with the newly developed drugs settles into the dreams of the afflicted
with deadly or hard to cure diseases: “I wish to have drugs before I will die.” Regardless
of whether the latest development is a cure or improvement or another form of death
warrant, what matters is to “have the drug out there.”
Robins tells us the story of the process of social reintegration of people with
AIDS in South Africa, involving a commitment to social activism and a “new life” as a
“responsibilized citizen” (Robins 2006). In a different context yet sharing resonating
concerns about the empowerment of patients, Steven Epstein eminently offers the
transformative process of lay people to semi-experts over the course of fighting for AIDS
treatments, who eventually played a significant role in changing the methodology of
clinical drug trials (Epstein 2006). Prior to Glivce, most patients with CML were
deprived of fundamental rights to decent life, experiencing to downgrade their social
status from normal, independent citizens to sick, dependable patients fraught with
struggles for life. Although they do not suffer from the social and cultural stigma like
people living with AIDS, it is true that a majority of them do not have career prospectus
and dreams about the future. Especially, young and unemployed patients are severely
affected by the diagnosis of the disease and ensuing illness experiences, which does not
necessarily suggest that they position themselves at the forefront of claiming their civil
rights as sick people.
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Captured as a series of an “awakening” moment, it was a ‘becoming’ process as
activists. Although they felt unfair that they had to fight to get available treatments,
patients left befuddled without a clue how to improve the situation. At that time, a few
members of blood cancer patients support group known as saebit nuri started to mobilize
concerned voices across diverse social groups such as physicians, pharmacists, and
grassroots activists. By working with professionals of medicine, pharmacy, and public
health, the members were awakened to learn about their clinical conditions with respect
to treatments, transnational pharmaceutical companies, intellectual property rights, and
the global trade order set by the WTO. As patients were gradually able to situate their
illness experience in a global perspective, patients’ political activism took shape.
With ethnographic references to community-based AIDS campaigns in Africa, Nguyen
delineates the formation of therapeutic citizenship, which is “a form of stateless
citizenship whereby claims are made on a global order on the basis of one’s biomedical
condition, and responsibilities worked out in the context of local moral economies” (p.
142). In the age of biomedical globalization, the humanitarian goal of health set the stage
for political activism as far as access to innovative treatments are concerned. Korea
leukemia patients came out with their illness more open when they felt better with the
new treatment and could carry on their daily lives. Not surprisingly, communications
taking place in the hallway of the Bone Marrow Transplant ward at a major teaching
hospital in Seoul, Korea were carried in more blunt and frank terms even with exchanges
about doctor’s therapeutic recommendations. Partly because of its nature that it is set up
in a sort of waiting room for a doctor’s appointment at a hospital and that a chance
conversation tends to last rather fleetingly, it can be surmised that patients and
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DRAFT
accompanied people are free to talk (or more like confess) about their illness experiences,
financial agonies, and the fear associated with illness, given that they suffer from the
same kind of disease. They tend to be reticent about things that are deemed to be personal,
such as financial difficulties inclusive of losing or finding a job. Financial matters are offthe-limits topic, and talks are focused on daily lives, alternative regimens (if used),
conversations with and recommendations from the doctor. Patients are very keen to make
sense of what they were told in the doctor’s office, by further exchanging the information
with patients in the waiting room.
Concluding Remarks32
In January 2003, the Korean government accommodated leukemia patients’
request to extend health insurance coverage of the drug, and Novartis Korea decided to
shoulder half the cost of the patient’s payment and agreed to refund the payment in cash.
In September 2005, the Korean government increased its level of support to 90 percent of
the price while an existing Novartis patient assistance program covered the remaining 10
percent. Thus, the drug is available to Korean leukemia patients free of charge.
The significance of the case lies in the processes by which civic organizations
come to question public health related matters and the international trade conditions
established by the World Trade Organization (WTO), for which the state has not yet fully
developed policies to guard its own interests. Under the circumstances in which the local
government is incapable of underwriting its interests, it is the NGOs that have contested
the dominant policy paradigms, such as intellectual property rights and drug pricing
policies imposed by international trade organizations, and suggested alternative ways of
solving problems, for instance, through policy comparisons with other countries, taking
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DRAFT
into account individualized agonies into the makeup of the market practices, which I
cautiously call an ethical or moral market.
They turned the case into an arena where the WTO order was in conflict with
domestic policies on the issue of intellectual property rights. Especially, the Solidarity
focused on the concept of the public interest and conditions and the grounds on which
intellectual property rights were granted. In the process, they made the unintended claim
that the government should play a strong and decisive role in protecting its citizens from
international intervention.33 This is epitomized by the request for a compulsory license:
direct and immediate involvement of the government to protect the people’s interests
from the interventions of the international conventions. It can be argued with caution that
when the government as a regulatory body is relatively weak at responding to imminent
and pressing issues, civic organizations seem to take on its role, trying to pressure the
government to react in the best interest of the people. To the extent that the NGOs have
taken the initiative in raising questions about the incumbent system and of suggesting
solutions it might be said that the Glivec case created bottom-up policy-making in Korea.
The NGOs made a controversial issue of something that might otherwise have gone
unnoticed, rather than directly getting involved in policy-making. This type of grass roots
involvement echoes what many scholars suggest, in that ‘governance’ has more to do
with “collective action resulting from the interactions of multiple, mutually influencing
actors, both within government and beyond its formal authority.”34 As this case shows, it
is a process resulting in shared responsibilities among the parties involved that effectually
blurs the boundaries between them.
22
DRAFT
It is known either as Gleevec™ in the U.S. (Imatinib Mesylate, STI-571), or as Gilvec® outside the
U.S.A. Under the orphan drug program of the US FDA, Novartis has been given financial incentives for the
development of drugs.
2
Petryna, Adriana. 2005. “Ethical variability: drug development and globalizing clinical trials,” American
ethnologist, 32 (2): 183-197; Rose, Nikolas & Carlos Novas. 2005. “Biological citizenship,” in Global
assemblages: technology, politics, and ethics ad anthropological problems edited by Ong, Aihwa and
Stephen J. Collier. Blackwell publishing.
3
Jasanoff, Sheila. 1997. NGOs and the Environment: from Knowledge to Action. Third World Quarterly
18 (3): 579-594.
4
In 2002, the U.S. Congress reviewed a bill that Medicare would provide coverage for all oral anticancer
drugs including Gleevec.
5
Arnold, Katherine. After 30 years of Laboratory Work, a Quick Approval for STI571, Journal of the
National Cancer Institute 93 (13), 2001, 972; Pezzella, Mike. 2001. FDA clears pill that tackles ‘Love
Story’ disease. Biotechnology Newswatch, 21 May. Gleevec was approved by the USFDA under the
‘accelerated approval program’ in May 2001, after thirty years of laboratory work. The new drug had
received extensive media attention not only in the United States but also in Europe, and was depicted as a
‘wonder drug’, a ‘miracle drug’, or a ‘love story’ drug due to its efficacy and high remission rate. In
particular, Biotechnolgy Newswatch ran an article referring to the newly developed anti-cancer drug as a
‘love story’ drug, since the actor, Ryan O’Neal played the leading man in the movie Love Story who was
diagnosed with cancer and treated with Gleevec, after the approval of the USFDA.
1
6
Expanded access is a means by which manufacturers make investigational new drugs
available, under certain circumstances, to treat a patient(s) with a serious disease or
condition who cannot participate in a controlled clinical trial. The primary intent of
expanded access is to provide treatment for a patient’s disease or condition, rather than to
collect data about the study drug. With the permission of the patient, physicians can
enroll the patient to be eligible for trying an investigational drug before the marketing
thereof.
In the meantime KFDA designated Gleevec as a ‘rare medicine’ via in-house screening procedures. Once
a medicine is categorized as a rare medicine, the KFDA can approve it without going through the final
stage of clinical testing, which takes longer than three years.
8
One leukemia patient complained, "I sold my house first to get Glivec. Afterwards I could barely afford to
rent a house semi-permanently and then rented on a monthly basis. And now our family is separated and I
cannot any longer see my children everyday ". In Korea, house ownership is one indicator of one’s
economic status. That someone has to rent a house on a monthly basis is a sure indicator that someone is
extremely poor, although the cost of monthly renting has been increasing since the economic crisis of 1997.
This is a quote from Song, Sang Ho. 27 February, 2003: “Society should share the burden of patients with
rare diseases and those suffering from diseases that are hard to cure. Han-Gye-Re Sin Moon. Op-ed. 12.
9
“희귀약 시장, 빅 파마 진출 잇따라” 2010 년 10 월 15 일 (금)
7
07:37:05http://www.pharmstoday.com/news/articleView.html?idxno=73738
10
Like other countries, environment-related NGOs have been well established.
Access is available at http://sbnuri.allmedicus.co.kr. It is a Korean-based website.
12
This group is named ‘JinBo’ meaning ‘progress’ as opposed to ‘conservative’ in Korean. Jibo has a
social/political leftist orientation. This group has been engaged in a variety of social and political issues
such as regulation of cyberspace, environmental issues, and education. Available from World Wide Web:
http://www.jinbo.net./.
13
When I was in Korea in the summer of 2002, I was asked to participate in the online signature movement
by members of the online community to which I belonged.
14
It is a civic group created by registered pharmacists, whose main agenda is evidently to secure fair and
equitable access to medicines for the Korean people.
15
It is a voluntary organization of licensed doctors in Korea, whose members share the common concern
with other civic organizations about the realization of representative democracy in Korea.
11
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DRAFT
Impressively, patients in patients’ gowns, at the risk of their lives, went out on street demonstrations. By
wearing patients’ gowns, masks, and baring bald heads, that is, looking like real leukemia patients, they
gave visual testimony to how they were suffering and to the desperate situation they were in. The
demonstrations were held during rush hours in business areas, and pictures of them were posted on the
Glivec website.
17
It was reported throughout the media that delegates were sent to India to see how feasible it was to
import a copy drug that would not contravene current laws regarding drugs imported for non-commercial
purposes. However, for whatever reason, neither the NGOs nor even individual patients imported a copy of
Glivec.
18
http://www.ipleft.or.kr The membership of IPleft is diverse and ranges from intellectual property lawyers
to university professors, researchers and activists. It is open to whomever is interested in the issue of
intellectual property rights. This website is linked to the Glivec advocacy group.
19
When they requested a compulsory license from the government, they identified themselves as the
‘Glivec Union’. However, they seemed to use ‘union’, ‘solidarity’, and ‘committee’ interchangeably, since
in other newspaper articles they were referred to as ‘the solidarity’. Because of their strong association with
labor unions, I would rather not use either union or solidarity.
20
A compulsory license system under the Korean Patent Law has existed since 1946 with slight changes
over time as a legal sanction against the misuse of patent rights. When the TRIPs that prescribes the
conditions for granting a compulsory license came into effect in Korea on 1 January, 1995, the government
revised the law according to the TRIPs.
21
They held a public discussion in July of that year under the theme “Compulsory Licensing of Glivec and
Public Non-Commercial Use of Medicine.”
22
In their reports on Glivec, the NGOs explicitly stated that their ultimate purpose was to build worldwide
connections with those who had been working on similar issues. They even discussed sending
representative to Brazil, India, etc. But I couldn’t find any data about whether they really sent
representatives. Their current work on an English-based website seems to reflect their aspiration to build an
international network.
23
It should be remarked here that documents on the Korean-version Glivec website are textualized either in
(Microsoft) Word or in the HanGuel Word Process (HWP) format, which is predominately used by
Koreans. Virtually all the documents are formatted in HWP. The documents formatted in MS Word
originate abroad and are written in English.
24
Nam, HeeSeob and Park, SungHo. January 30 2002. Petition for a Compulsory License.
25
Choi, Young-Chol. 2002. Glivec Trauma, We Can’t Wait for Death. Weekly DongA. 17 October, 356.
26
It is estimated that there were about 500-600 CML patients waiting for Gleevec to be marketed in Korea.
27
Ibid.
28
Ryu, Jin. 2002. US Presses Korea Not to Alter Pharmaceutical Pricing Plan. Korea Times. An, YoungChoon. 2002. The Ministry of Health and Social Welfare Get My Permission. Han Kye Re 21, 24 July, 419.
29
In February 2001 the division of labor between pharmacists and doctors relating to prescriptions and
dispensations was enforced. It has been reported in the media that the use of products of foreign
pharmaceutical companies have been rapidly increasing mainly because doctors prescribe medicines by
product names rather than by the symptoms of their patients. And domestic products are not as well
recognized as the imported ones. The news media has suspected that foreign pharmaceutical companies
have been lobbying doctors by providing them with opportunities to attend conferences overseas on the
condition that they prescribe their products.
30
This is the second time that Novartis has had a hard time marketing a drug: in 1999, its ‘Sandimmun
Neoral’ an immuno-suppressant used for preventing graft rejection after organ and bone marrow transplants,
ran into difficulty. When the Korean government tried to incorporate the imported drug into the national
insurance scheme the listed price that the Korean government proposed was far lower than the market price
so Novartis threatened to stop selling it in Korea.
31
Seo, Jee-Yeon. 2003. Foreign Pharmaceutical Feel Isolated in Korean Market. Korea Times. 9 February.
32
In the summer of 2002, I saw a documentary film in Korea featuring suffering leukemia patients
endeavoring to get treatment: patients who were hospitalized and patients who were on demonstrations
against the makers of Glivec and other multinational pharmaceutical companies. I was astonished to see
patients actively working to secure the right to treatment rather than waiting to be helped. Soon after the
program ended, I asked my friends and family if they were aware of leukemia patients in relation to Glivec.
16
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DRAFT
All of them were, and ridiculed my ignorance of it. What intrigued me was that NGOs and patients were
making the Glivec case “controversial” and creating room for “dissensus” as a way of participating in the
policy-making process.
33
It might be interesting to see how the collective memory of convoluted contemporary Korean history -from the time of Japanese rule through to the American military occupation and on to despotic
governmental rule -- would come into play when mobilizing collective power against a dominant and
hegemonic rule.
34
Levidow, Les, and Marris, Claire. 2001. Science and Governance in Europe: Lessons from the Case of
agricultural Biotechnology. Science and Public Policy 28 (5): 345-360. p. 346.
Puedue, Derrick. 1999. Experiments in the Governance of Biotechnology: a Case of the U.K. National
Consensus Conference. New Genetics and Society 18 (1): 79-99. Stoker, Gerry. 1998. Governance as
Theory: Five Propositions. ISSJUNESCO
25