letter to the WTO member countries on TRIPS and access to health care
On the eve of last year's WTO Ministerial Conference in Seattle, Medicins Sans Frontieres, Health Action International and Consumer Project on Tchnology issued the following open letter to members of the multilateral trade body urging the latter to consider initiating moves, both within and beyond the framework of the TRIPS Agreement, to promote equitable access to health care. While no follow-up thereto was forthcoming from the Ministerial, which ended in collapse, the proposals in the letter remain as relevant as ever, emphasising as they do the centrality of upholding public interest in framing international trade regulations on essential health care goods.
16 November 1999
Dear member of the WTO,
WE are writing to express our views on the future discussions at the WTO on issues relating to health care technologies. We form a coalition of health professionals working in developing countries, public health advocates and consumer groups and health and development NGOs. We wish to draw your attention to issues in the implementation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) that relate to access to health care technology.
barriers to access to essential medical products will lead to an increase
of preventable illness and death, particularly in developing countries.
In our view international trade regulation of essential health care goods
merits a new approach in which public interest is the key motive rather
than commercial interest.
1999, after more than a year of debate, the World Health Assembly unanimously
enacted resolution WHA52.19, calling upon member states:
Public health considerations in trade policy
Health Assembly resolution signals the beginning of a much-needed dialogue
among governments, international organisations, NGOs and industry regarding
trade agreements and health care technologies. The resolution gives the
WHO a new mandate to monitor the health implications of trade agreements
and provide assistance to countries in implementing trade regulation while
protecting public health. Indeed, there are signs that support for greater
sensitivity to public health considerations in trade is gaining momentum.
For example, over the past six months, high officials from the WHO, UNAIDS,
the World Bank, and several national governments have expressed support
for the use of compulsory licensing of patents to address the global HIV/AIDS
crisis. There are several international discussions taking place regarding
the WTO's Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) to determine if and how the TRIPS might be changed or interpreted
to ensure that public considerations are indeed paramount in trade policy.
alternatives to TRIPS:
to begin discussions on new approaches to the TRIPS for health care technologies,
that would replace the current emphasis on the protection of private commercial
rights with a system obligating countries to support essential medical
research and development that addresses public health needs. This new
approach should ensure accessibility of these new technologies for those
who need them.
full support to WTO members to implement the TRIPS requirements in national
legislation that gives the highest possible priority to protecting the
public interest and to remedying abuses of the monopoly by the patent
and principles outlined in Articles 7 and 8 of the TRIPS agreement provide
a strong public interest framework for the interpretation and implementation
of intellectual property rights. Article 7 sets out the need to balance
intellectual property rights protection with the promotion of technological
innovation and the transfer and dissemination of technology 'in a manner
conducive to social and economic welfare'. Article 8 outlines the rights
of members to adopt measures to protect public health, to prevent abuse
of the intellectual property rights and to prevent the obstruction of
international technology transfer, provided that these measures are consistent
with the provisions of the TRIPS.
discussions on proposals to exempt essential drugs from certain TRIPS
published the first Essential Drugs List (EDL) in 1977. This list was
defined by the WHO as 'those [drugs] that satisfy the health needs of
the majority of the population [that] should therefore be available at
all times in adequate amounts and in the appropriate dosage form.' It
is important to note that the inclusion criteria for the WHO's EDL are
not only safety and efficacy, but also economic considerations, specifically
the price of the products. Many drugs that are considered essential from
a therapeutic or public health point of view are not included, because
of their high cost. (Only extremely limited use of HIV/AIDS drugs for
the prevention of mother-to-child HIV transmission during birth is included,
despite the fact that approximately 30 million persons infected with HIV/AIDS
will die in the next decade without access to AIDS drugs.) Thus, it is
useful to appreciate that the EDL itself is dependent upon the prices
of drugs, and the prices are related to the intellectual property rules
applied to those drugs.
discussions on the issue of patent exceptions for medical research. In
this respect, ask the WHO to request comments from the academic and commercial
research community on the barriers to medical research presented by current
intellectual property regimes, and to advise the WTO on the issue of the
legitimate interests of third parties in medical research.
also be important to provide the WTO with strong statements in favour
of so-called 'bolar' type patent exceptions that are used in the United
States, Canada, Israel and some other countries to permit generic drug
companies to perform tests on bioequivalence and other issues on patented
drugs in order to prepare applications for regulatory approval as generic
drugs when the patent expires. Again, countries and international organisations
like the WHO can provide a record to support the legitimacy of such patent
exceptions, emphasising the public health benefits of generic drug competition.
absence of data exclusivity, generic drugs or drugs produced under a compulsory
licence can be introduced into the market on the basis of simple bioequivalence
tests, without having to replicate time-consuming and expensive clinical
trials that are used to establish the efficacy and safety of the products.
But if countries are required by the WTO to adopt excessive protection
for data exclusivity, there will be problems with providing marketing
authorisation for generic products and drugs produced under a compulsory
licence using existing registration data.
that WTO member countries should not use unilateral trade pressures to
prevent national governments from using compulsory licensing of patents
or other policies to meet the country obligations to protect public health
interests. Indeed, we strongly support agreements that would prevent trade
sanctions against countries that do not implement obligations beyond that
required by the TRIPS on policies that concern access to medicines.
We hope that you will consider the issues raised in this letter as you prepare for the discussions at the WTO Ministerial Conference in Seattle.
Pecoul, Director, Access to Essential Medicines Project, Medecins Sans
Sans Frontieres is the world's largest independent medical relief organisation,
providing care to victims of war, disasters and epidemics in 80 countries
world-wide. MSF was awarded the 1999 Nobel Peace Prize.