E-drug: Sign the Open Letter to the WTO
---------------------------------------------
WARNING: LONG MESSAGE
Dear E-drug readers,
Medecins Sans Frontiers, Health Action International and Consumer Project
on Technology invite you to support an open letter to the WTO members.
Please find the text below.
We invite you to:
- sign on to the letter. Send your signature to e-mail:
ingeborg_martens@amsterdam.msf.org
- send the letter to your country delegation that will go to the WTO
Ministerial meeting in Seattle
You can also find the letter on the MSF Web-site and sign on there.
http://www.msf.org/advocacy/accessmed/wto/reports/1999/letter/
8 November 1999
Open letter to the WTO Member Countries on
TRIPS and Access to Health Care Technology
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. Unnecessary 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.
In May 1999, after more than a year of debate, the World Health Assembly
unanimously enacted resolution WHA52.19, calling upon member states:
(1) to reaffirm their commitment to developing, implementing and monitoring
national drug policies and to taking all necessary concrete measures in
order to ensure equitable access to essential drugs;
(2) to ensure that public health interests are paramount in pharmaceutical
and health policies;
(3) to explore and review their options under relevant international
agreements, including trade agreements, to safeguard access to essential
drugs.
The World 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 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.
Our recommendations to the WTO member countries are to consider several
possible actions at the Seattle Ministerial meetings. The proposals
reflect different strategies or tactics, address both narrow and broad
issues, and include proposals for changes in the TRIPS as well as issues
that can be addressed within the implementation of the existing agreements.
They are as follows:
(i) Regarding alternatives to TRIPS:
1) Begin discussions on a new paradigm for TRIPS on the issues of health
care technologies. This new paradigm should focus on and promote health
care research and equitable access to health care.
We propose 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.
The alternative to the TRIPS should include a system for global sharing of
the research burden related to a country's stage of development and ability
to pay and should ensure equitable access to the results of the research.
We ask that the WHO, the World Bank, The World Intellectual Property
Organization, the WTO, the United Nations Conference on Trade and
Development and other appropriate international organizations, interested
national governments and public health and trade experts meet with public
interest NGOs to discuss this proposal in the coming year.
(ii) Within the context of the current TRIPS framework:
1) Explore expansion of the transitional period for TRIPS implementation in
developing and least developed countries until mechanisms to remedy the
effects on access to essential health technologies are in place.
2) Give 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
holder.
The objectives 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.
Developing countries in particular should be actively encouraged to use this
framework to the fullest.
3) Support discussions on proposals to exempt essential drugs from certain
TRIPS obligations.
The WHO 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 therefor be available at all
times in adequate amounts and in the appropriate dosage form."1. 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.2 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.
4) Support 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.
It will 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
organizations like the WHO can provide a record to support the legitimacy
of such patent exceptions, emphasizing the public health benefits of generic
drug competition.
5) Avoid restrictive and anti-competitive interpretations of country
obligations under Article 39 of the TRIPS, concerning health registration
data.
Article 39 of the TRIPS is a little debated and little understood provision
that requires WTO members to protect health registration data from
disclosure or unfair commercial use. Some have argued that if a country
requires the use of scientific data to register a pharmaceutical product for
sale, the TRIPS requires countries to provide some level of exclusivity for
that data, including restrictions on the ability to rely upon the data to
register a competing product. In bilateral trade actions, the US
government has argued that countries are obligated by the TRIPS to prevent
generic drug companies from even relying upon published scientific papers
or foreign government regulatory approvals, without permission from the
"owners" of the data that the papers or approvals were based upon.
In the absence of data exclusivity, generic drugs or drugs produced under a
compulsory license 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 authorization for generic products and drugs produced
under a compulsory license using existing registration data.
At present, several countries, including the US and the members of the EU,
provide several years of data exclusivity, for purposes of regulatory
approval of pharmaceuticals. There are proposals from public health groups
to replace current US and EU rules on data exclusivity with new rules that
curb abuses such as the Taxol (Paclitaxel) case. 3 Some proposals would
include requirements that companies make public disclosures of the actual
costs of clinical trials and other data they seek to protect from "unfair
commercial use," and that protections be reasonably related to the actual
investment costs.
The actual impact of Article 39 on competition and access to drugs is quite
unclear, because the language in the Article is not precise regarding
country obligations. The WTO interpretations of country obligations will be
critical. There is a need to examine the empirical evidence and economic
analysis used to support various national policies regarding exclusive
rights to health registration data, as well as the historical justification
given for such policies. The WHO should provide the WTO with a report on
the least trade restrictive policies with regard to protection of such
data, and accept public comment on anti-competitive aspects of current
national regimes, including the 10 year period used in the European Union,
that was initially introduced to compensate for the lack of patent
protection in Spain and Portugal. By providing the WTO with a
communication on the need to avoid excessive and anti-competitive levels of
data exclusivity, countries can help set a pro-public health agenda on this
issue.
6) Ask the WHO to issue a report to the WTO on the issue of patent
exceptions under Article 30 of the TRIPS, as they relate to the export of
products to countries that issue compulsory licenses. This is a very
important issue for those countries that do not have sufficient domestic
markets to make domestic production of pharmaceutical drugs feasible, but
that could benefit from the import of a product under a compulsory license.
For example, a country such as India with a population of one billion can
support a sophisticated domestic pharmaceutical industry, but smaller
economies such as Botswana or Nicaragua cannot. It makes no sense at all
to have a global trading system that would permit China, Brazil, India,
Argentina, Germany, the United States, Japan and other large domestic
markets to benefit from compulsory licensing, while smaller market
countries cannot. Moreover, it is economically inefficient to limit
national
procurement of pharmaceutical products to domestic suppliers alone. In our
opinion, in their national legislation, a country can currently provide an
exception in patent laws for products that are manufactured for sale in a
foreign market where the foreign market has issued a TRIPS-compliant
compulsory license. We believe the exporting country's issuance of a
compulsory license protects the legitimate interests of the patent owner.
However, it would be extremely useful to request a report from the WHO to
the WTO on this issue, both to reduce uncertainly and to influence any
possible future WTO jurisprudence on this issue.4
The Article 31 provisions in the TRIPS say that in most cases, compulsory
licenses should be used predominately for the domestic market, and some
companies have indicated they will ask that countries not be permitted to
export products produced under a compulsory license. While we believe such
exports would be appropriate and permitted under the TRIPS Article 30
regarding exceptions, when the export market has a TRIPS compliant
compulsory license in place, this is certainly an area that would benefit
from discussion and clarification, particularly given the public interest in
fairness and efficiency.
7) Trademark Rights and Public Health. The WTO should request a report
from the WHO on the issue of public health perspectives on trademark
policy. The WTO should clarify that TRIPS would not prevent a country from
requiring certain packaging and labelling requirements in areas where the
regulation is to promote public health. This is particularly important for
the implementation of generic drug policies. The WTO should make it much
clearer that the TRIPS should not be used to prevent governments to require
the use of generic names of drugs on product packaging, in prescribing
practices, or in generic substitution policies by pharmacies and health
care providers.
8) Declare that WTO member countries should not use unilateral trade
pressures to prevent national governments from using compulsory licensing
of patents or other polices 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.
Sincerely,
Dr Bernard P�coul
Director Access to Essential Drugs Medicines Project
M�decins Sans Fronti�res
Dr K. Balasubramaniam
Health Action International
James Love
Director, Consumer Project on Technology
1The WHO Model List of Essential Drugs is regularly updated. The 10th
updated EDL can be found at: http://www.who.int/dmp/Model_List/edl-10.htm
2 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.
3 To provide a context for this issue, consider the case of fluconazole, a
drug used to treat cryptococcal meningitis, a disease that afflicts many
people living with HIV/AIDS. Fluconazole sells for $14-25 per daily dose
in markets where Pfizer has market exclusivity, but can be acquired for
$0.75 per daily dose or less in countries where there is generic
competition. The difference in price is a matter of life or death for
hundreds of thousands of people with HIV/AIDS.
4 Paclitaxel is a treatment for breast and ovarian cancer, and for Kaposi's
Sarcoma. Paclitaxel was invented by scientists employed by the US
government, and sold as Taxol by Bristol-Myers Squibb. BMS uses its
exclusive rights to US government sponsored research to claim marketing
exclusivity under national laws that provide Article 39 type protections of
health registration data. BMS receives in excess of $1.2 billion annually
for Taxol, and sponsored none of the clinical trials for which initial
registration of the drug were based. The high prices charged by BMS for
Taxol have led to serious access problems for patients suffering from
malignant diseases.
For further information contact one of the following organisations
M�decins Sans Fronti�res is the world's largest independent medical relief
organization, providing care to victims of war, disasters and epidemics in
80 countries world-wide. MSF has been rewarded the 1999 Nobel Peace Prize.
M�decins Sans Fronti�res - Access to Essential Medicines Project
Rue du lac 12
1211 Geneva 6
Switzerland
Tel: + 41 22 8498406
Fax: + 41 22 8498404
E-mail: Bpecoul@msf.org
Health Action International is a network of more than 200 consumer, health,
development action and other public interest groups involved in health and
pharmaceutical issues world-wide.
Health Action International - European Office
Jacob van Lennepkade 334T
10533 NJ Amsterdam
The Netherlands
Tel.: +31 20 6833684
Fax: +31 20 6855002
e-mail: hai@hai.antenna.nl
or
e-mail: ardaroap@tm.net.my
Consumer Project on Technology is a US based non-profit research and
advocacy organisation created by consumer advocate Ralph Nader. Its
activities focus on information technologies, intellectual property and
research and development.
Consumer Project on Technology
P.O. Box 19367
Washington D.C. 20036
United States of America
Tel: + 1 202.387.8030
Fax: + 1 202.234.5176
e-mail: love@cptech.org
http://www.cptech.org
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.