E-DRUG: Lancet: public health vs commercial interest
-------------------------------------
[Long but important "viewpoint" article in the Lancet; Copied as fair use;
WB/BS]
Lancet Volume 363, Number 9408 14 February 2004; 560-63
http://www.thelancet.com/journal/vol363/iss9408/full/llan.363.9408.editorial
_and_review.28749.1
Viewpoint
The role of civil society in protecting public health over commercial
interests: lessons from Thailand
Nathan Ford, David Wilson, Onanong Bunjumnong, Tido von Schoen Angerer
In October, 2002, two Thai people with HIV-1 won an important legal
case to increase access to medicines. In its judgment in the
didanosine patent case against Bristol-Myers Squibb, 1the Thai
Central Intellectual Property and International Trade Court ruled
that, because pharmaceutical patents can lead to high prices and
limit access to medicines, patients are injured by them and can
challenge their legality. This ruling had great international
implications for health and human rights, confirming that
patients--whose health and lives can depend on being able to afford a
medicine--can be considered as damaged parties and therefore have
legal standing to sue.
The complexities of pharmaceutical intellectual property law are most
poorly understood by those most affected by their consequences--the
patients who need the drugs. The Thai court case was the outcome of a
learning process and years of networking between different civil
society actors who joined forces to protect and promote the right of
access to treatment.
Our Viewpoint, based on key interviews and published reviews,
summarises the efforts of civil society in Thailand to achieve a fair
balance between international trade and public health. These efforts
have focused on didanosine, an essential antiretroviral drug that in
Thailand has become symbolic of how multinational companies and
governments of industrialised countries protect their own interests
at the expense of access to essential medicines for the poor.
Early efforts to provide treatment
Thailand is a low-to-middle income country with a population of 63�5
million, of whom about 603 000 have HIV/AIDS (adult infection rate is
1�8%). The country is noted for an effective response to the
epidemic. 2-4 The Thai Public Health Ministry began to provide
antiretroviral monotherapy in 1992 and dual therapy in 1995 for an
estimated 25% of symptomatic patients attending public hospitals.
However, in 1995 specialists concluded that continuing the programme
would be costly with minimum effectiveness, 5although their analysis
did not take into account the possibility of lower prices due to
generic competition or of the greater effectiveness of triple
therapy. In 2000, the Public Health Ministry began to promote triple
therapy as the norm, using mostly brand name drugs. However, coverage
was limited by the price of medicines.
For several years, the only antiretroviral drugs commonly available
in Thailand were zidovudine and didanosine. By 1996, generic
zidovudine was available at a reasonable price, but generic
production of didanosine was blocked by the patent holder
Bristol-Myers Squibb (panel 1) 6-15 and the brand drug cost more per
month (US$136) than the average wage of an office worker (US$120). 16
Panel 1: Privatisation of a public drug
February, 1998--US National Institutes of Health (NIH), 6which
invented didanosine, grants a licence to Bristol-Myers Squibb (BMS)
to produce the drug in a limited list of countries, excluding
Thailand, for an initial period of 10 years, with option of 5-year
extension. Licence includes fair-pricing clause, stating that "there
be a reasonable relationship between licensee's pricing of licensed
product and the health and safety needs of the public and that this
relationship be supported by evidence". 7Despite repeated requests by
MSF and others, NIH has never enforced fair pricing clause, nor has
BMS honoured it. Thus, attempts by the Thai Public Health Ministry's
AIDS division to negotiate the price of didanosine have been
unsuccessful 8
July, 1992--BMS files patent application for formulation of
didanosine in Thailand, containing different antacid buffer to
original preparation and with a specified dose range "from about 5 to
100 mg per dosing unit" (similar to 5-150 mg formulation patents in
other countries 9,10 ). Similar patent applications in USA in 1991 11
and 1992 12 rejected on the grounds of lack of novelty and inventive
step, although new version of US patent finally granted in March,
1999. 13 Application made for a product patent 2 months before
product patents recognised in Thailand
August, 1997--BMS files an amendment in which dose restriction
omitted, thus seeking to expand scope of patent to all preparations,
containing didanosine plus antacid buffer irrespective of dose
January, 1998--Thai Department of Intellectual property grants amends
patent. 14 Amendment never published
April, 1998--Launch of generic didanosine 150 mg tablets by GPO
planned. BMS threatens litigation and blocks production 15
October, 2002--Omission of dose range in patent amendment found to be
unlawful by Thai Central Intellectual Property and International
Trade Court. BMS appeals
January, 2004--BMS withdraws appeal; judgment upheld in favour of plaintiffs
Since 1975, the US pharmaceutical industry has claimed that lack of
product patents acts as a barrier to market entry in Thailand, and
the US government has put trade pressure on the country to introduce
stronger patent protection through trade sanctions, representing
US$165 million in lost export revenue for Thailand. 17 In response to
this pressure, Thailand has introduced a series of measures, 16 which
maximise the rights of the multinational pharmaceutical industry
while minimising the rights of patients, with little benefit to the
national industry in terms of foreign investment and technology
transfer. 18
Civil society groups are strong and numerous in Thailand, and have
been central to defending and promoting access to medicines (panel
2). In 1999, the Didanosine Working Group was formed as a result of
concern about Thailand's patent laws, which they believe constituted
a major barrier to access to HIV/AIDS drugs, a view confirmed by the
findings of a joint UNAIDS/WHO fact-finding mission to Thailand in
1999. The mission recommended that the Public Health Ministry review
its patent provisions on compulsory licensing and institute a means
of monitoring drug prices, with assistance from WHO. 19
Panel 2: Civil society groups and non-governmental organisations
(NGOs) promoting access to medicines in Thailand
Thai Foundation for Consumers
Founded in 1983
Lobbies on issues around patent protection and access to medicines
Played a key part in informing patient groups about such issues
Thai NGO Coalition on AIDS (TNCA)
Formed in 1989
Gained early success through the disbanding of an AIDS Bill proposed
in 1990 that would have required compulsory HIV testing of any member
of a high-risk group without their consent 4
Comprises 168 national and international NGOs
Thai Network for People Living with HIV/AIDS (TNP+)
Established in 1998
Coordinates activities of groups of people living with HIV/AIDS across
Thailand
M�decins Sans Fronti�res
Began working in Thailand networking in 1994 at invitation of local
NGOs. Early work included support to local NGOs, including medical
care for people with HIV/AIDS. Started to provide antiretroviral
treatment in October, 2000
In November, 1999, the Thai Government Pharmaceutical Organisation
(GPO) submitted a request for a compulsory licence (a legal measure
that allows governments to over-ride patents and produce generic
medicines) to the Thai Department of Intellectual Property. This
request was supported by several local non-governmental
organisations, by the Thai network of people living with AIDS, and by
M�decins Sans Fronti�res (MSF). The occasion represented the first in
Thailand when people infected with HIV braved stigmatisation to stage
public demonstrations, and proved to be a watershed event in terms of
awareness and self-confidence for people with HIV/AIDS. At the same
time, US AIDS activists demonstrated in Washington, DC, against
Bristol-Myers Squibb and the US government, regarding their
repressive trade policy with respect to drugs for HIV in Thailand and
South Africa.
A letter from the US Ambassador in Bangkok to the US Trade
Representative stated that the Thai government "certainly don't want
to be the cause of a trade dispute just before the Seattle Meeting
[1999 World Trade Organisation (WTO) Ministerial], which is what we
have always told them would happen if the compulsary [ sic ]
licensing clause should be invoked". The USA was concerned that this
would "set a worrisome precedent for the rest of the drug industry".
20
In January, 2000, Thai activists submitted a letter to the US
government, demanding that they not retaliate with trade sanctions if
a compulsory licence was issued. This correspondence was backed by
the Washington based Consumer Project on Technology. 21 The US
government responded, "the United States will raise no objection,
provided the compulsory license is issued in a manner fully
consistent with . . . TRIPS [trade-related aspects of intellectual
property rights]". 22 But this reply did not assuage fears of US
trade retaliation. A senior official at the commerce ministry said,
"Thailand has committed to the international community not to use
poverty and sickness as an excuse in international trade". He
expressed concern that, "if a compulsory license were to be issued,
just one million people will benefit, while the rest of the country's
61 million people will have to pay the price if the US retaliates." 23
The use of compulsory licensing was rejected. 24 Instead, the GPO
began to produce a non-patented formulation of didanosine--a
citrate-phosphate buffer formulation with more gastrointestinal
side-effects than the patented drug.
Bristol-Myers Squibb taken to court
A lawsuit was filed in May, 2001, at the Thai Central Intellectual
Property and International Trade Court by the AIDS Access Foundation
(a Thai foundation that provides social support to people with
HIV/AIDS) and two patients with HIV against Bristol-Myers Squibb. The
plaintiffs alleged that Bristol-Myers Squibb and the Thai Department
of Intellectual Property had "conspired to intentionally delete" the
dose restriction to the didanosine patent. The court summoned the
Department of Intellectual Property as a co-defendant.
One of the central questions in the case became whether individuals
have the right to challenge a patent. The defendants claimed that the
plaintiffs "do not have the objective to manufacture didanosine, and
can choose other medicines to cure the disease, and are therefore not
injured or interested parties". 1However, in the final verdict, the
court noted that "Medicine is one of the fundamental factors
necessary for human beings, as distinct from other products or other
inventions that consumers may or may not choose for consumption" and
that "lack of access to medicines due to high price prejudices the
human rights of patients to proper medical treatment". 1
The court went on to assert the primacy of human life in trade
agreements, as recognised internationally at Doha where "it was
insisted that TRIPS be interpreted and implemented so as to promote
the rights of members to protect public health, especially the
promotion and support of access to medicines". 1This occasion is
believed to be the first time a court decision has used the Doha
Declaration to protect public health and the rights of patients. It
concluded that "injured parties . . . are not limited to
manufacturers or sellers of medicines protected by patent. Those in
need of the medicine are also interested parties to the granting of
the patent." The AIDS Access Foundation was also noted as an
interested party, 1affirming the important role of civil society
groups.
Furthermore, the court noted that the removal of the restriction on
dose range extended the patent protection beyond the scope of the
initially described invention. The court ruled this amendment
unlawful. This ruling has set an important precedent that essential
drugs are not just another consumer product but a human right, and
that patients are injured by patents. The defendants initially
appealed, but withdrew this appeal in January, 2004.
Unsurprisingly, the parties involved had different views of the
outcome. Although a spokesperson for BMS claimed they had decided to
"dedicate the patent to the people of Thailand", one of the
plaintiffs said that "this did not happen because the drug company
wants to be kind to people living with HIV/AIDS in Thailand. It is
the result of our fight to improve access to medicine". 25
Thailand and beyond
The Thai Public Health Ministry has clearly stated that their
ambitious antiretroviral treatment programme would not exist without
generic drugs (Chitwarakorn A, Public Health Ministry, personal
communication). The GPO produces seven antiretroviral preparations,
which are two (nevirapine) to 25 (stavudine) times cheaper than the
cheapest brand equivalents.
The use of locally produced generics has allowed the government's
treatment programme to expand more than eight-fold in the past 3
years with only a 40% increase in budget. As of May, 2003, 13 000
patients are receiving antiretroviral treatment; coverage is planned
to increase to 70 000 people, using funds from the Thai government
and from the Global Fund to Fight AIDS, Tuberculosis, and Malaria.
Thus almost 10% of people with HIV/AIDS in Thailand will receive
treatment within 2 years; most of those in need of antiretroviral
treatment, according to the Public Health Ministry. 26,27
By 2005, developing country WTO members must implement the TRIPS
agreement in full. Without the effective use of safeguards to ensure
generic competition, the cost of all new medicines will largely
depend on price setting by the patent holder. 28 The Thai didanosine
patent is an example of the problems faced by developing countries,
and intergovernmental organisations, such as the World Intellectual
Property Organisation (WIPO), should be more active in helping them
to overcome the formidable challenges in implementing patent
protection, including examining patent applications properly. 18,29,30
Countries also need assistance in meeting their obligations under the
Doha Declaration and in implementing the TRIPS agreement in a way
that protects public health and promotes access to medicines for all.
The TRIPS agreement contains safeguards to protect public health, but
in practice developing countries face political and practical
obstacles to using these safeguards. In Thailand, the government has
faced considerable trade pressure from the USA, and public health has
suffered as a consequence.
World Health Assembly resolutions in May, 2003, strengthened WHO's
mandate to promote policies that increase the availability of generic
medicines. 31,32 WHO and WIPO should provide technical expertise to
countries in the developing world with respect to the inclusion of
effective public-health safeguards in national patent laws. 15 The
constraints faced by countries in implementing these recommendations
are exemplified by the fact that none of the recommendations of the
1999 UNAIDS/WHO fact-finding mission to Thailand, restated by a
second UNAIDS/WHO mission in 2000, 33 has been implemented.
In Thailand, civil society groups have been key to establishing the
human right to health by challenging the practices of the
multinational pharmaceutical industry and governments of
industrialised countries (panel 3). 34,35 However, there are few
developing countries where civil society is strong in advocating for
greater access to medicines (Brazil and South Africa are notable
exceptions). Access to medicines for people in poorer countries risks
being limited by monopolies, arising from over-restrictive patent
laws and invalid but unchallenged patents for some time to come.
Panel 3: Campaigning for access to didanosine--views of Thai activists
"Treatment is not only an issue for doctors. People with HIV/AIDS
should be in the driving seat."
Bunniam, TNP+
"If people do not have a good understanding of the issues they cannot
say why they are there [at the demonstrations]. They need to do a bit
of homework. It's a chance to strengthen the network. In the past
people only talked about small issues, to do with themselves. This
was a wider issue that brought people together. People who joined the
protest feel that they are part of this change: they make the
difference and they feel proud. Some people now only work at the
policy level and have lost touch with their community. They must keep
the support of people in the regions."
Bandon Khamrangsi, MSF
"It's been a lot of work, challenging. It was a new issue, starting
from zero, but it's been a pleasure because it has given hope in a
situation where people couldn't previously access medicines. The
movement is not just about demonstrations. There are other
activities. It's a process. You need to explain clearly the goal of
the movement and of each milestone and explain clearly what needs to
be done. MSF is really a big help, especially the technical
knowledge: you have to confront doctors and the Public Health
Ministry and you really need the medical backup. Also MSF helps to
simplify the medical stuff and make the knowledge easy so that it can
then be passed on to and used by other patient groups. The response
of government has generally been quite positive. They listen to us
more. Before 1999 the Public Health Ministry didn't really think
about access to antiretroviral treatment, only about small programmes
and studies. Didanosine is just an example of the whole problem
related to patent monopoly and access to medicines. It's not the
solution but it's the point from where you make the case. The
didanosine case is going to be a good example for other countries, as
is this whole movement."
Nimit Tienudom, AIDS Access Foundation
"I want to portray a positive image to show that people are still
vibrant, driven and alive although they have HIV . . . It was a
public challenge to the government. We wanted to show the government:
we are here. There is a strong movement. We want you to act."
Kamon, TNP+
Statements made during interviews for research of this Viewpoint.
The pharmaceutical industry will continue to push for increased
patent protection. 36 In Thailand, successful opposition has come
from people with HIV/AIDS, who have fought for their rights by
forming effective coalitions, bringing together a range of experience
and expertise. Their experience has not only increased access to
treatment, but has brought wider benefits in terms of self-image,
confidence, and dignity of people with HIV/AIDS. Thailand's example
can only be encouraged.
Conflict of interest statement: None declared.
Acknowledgments
We thank the following people, who gave advice and time during the
research of this paper (some family names have been omitted on
request): W Chaichana, B Khamrangsi (MSF); W Chinvorasopak (Program
for Appropriate Technology in Health); A Eksaengsri (GPO); S Jaidee
(Health and Development Foundation); K Kaplan, P Suwannawong (Thai
Treatment Action Group); P Chalermchai, R Hern, Kamon, Bunniam
(TNP+); K Timmermans (WHO); N Tienudom (AIDS Access Foundation);
Saree (Foundation for Consumers); J Sorachai (Drug Study Group); J
Limpananont (Social Pharmacy Research Unit); N Supatra (Centre for
AIDS Rights); P Ebrahim, B Chuaydamrong (Law and Solicitors Ltd); S
Kasemsri (The Unified Counsel Ltd); S Rugpao (Department of Medical
Sciences, MoPH); A Chitwarakorn, and S Chasombat (Department of
Disease Control, MoPH). The MSF AIDS programme in Thailand is
cofinanced by the European Commission. The sponsors had no role in
the research and writing of this Viewpoint. The views expressed are
those of the authors and not those of the European Commission.
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