Dear rn,
The WTO meeting in Seattle seems to be serving a useful function in
focusing activist attention on the WTO, as shown again in the posting
below. This is a sign of realism, as regards the structure of elite power
in the world today. Activists are realistically bypassing the bankrupt
national political process and targeting attention where real power lies.
Such a focus also opens the door to collaboration between third-world
activists and Western activists, as the WTO is a common threat. A focus on
national politics divides the world's population; a focus on the WTO can
unite.
I hope Seattle is used as an opportunity for web-weaving between Western
activists and their third-world counterparts. In the previous posting we
heard of an alliance between the 'steelworker' and the 'environmentalist'
in the US. May we look forward to alliances between Brazilian farmers and
Kansas farmers, or between British steelworkers and Korean steelworkers.
solidarity,
rkm
============================================================================
Date: Mon, 8 Nov 1999 19:34:39 -0500
From: James Love <•••@••.•••>
To: Multiple recipients of list INFO-POLICY-NOTES
<•••@••.•••>
Subject: OPEN LETTER TO THE WTO MEMBER STATES REGARDING ACCESS TO MEDICAL
TECHNOLOGIES
This is one of the things CPT is doing with the WTO meeting
in Seattle later this year. Jamie
------------------------------------
SIGN THE OPEN LETTER TO THE WTO MEMBER STATES
REGARDING ACCESS TO MEDICAL TECHNOLOGIES
The following is an open letter to WTO members, regarding access
to health care technologies. The letter is endorsed by Médecins
Sans Frontières (MSF), Health Action International (HAI) and
Consumer Project on Technology (CPT). Additional endorsements
are welcome (see below).
The letter is rather long, and often addresses technical issues
in the WTO's Agreement on Trade Related Aspects of Intellectual
Property (TRIPS). The letter provides specific suggestions for
alternatives to TRIPS, but also points to issues of concern in
fine tuning of TRIPS, as well as issues that will be addressed in
the implementation of TRIPS. Some of the fine tuning or
implementation issues concern technical issues that are important
for compulsory licensing of patents (see 5 and 6), while others
address concerns such as the relationship between trademark
rights and public health policies (7), or the rights of
researchers (4).
An HTML version of the letter is on the web here:
http://www.msf.org/advocacy/accessmed/wto/reports/1999/letter/
A text version is on the web here:
http://www.cptech.org/ip/health/wto-99-signon.txt
Jamie
<------------An open letter to the WTO Member------------------>
First posted: November 8, 1999
SIGN THE OPEN LETTER TO THE WTO MEMBER STATES
If you would like to sign an open letter to the WTO Member States
regarding the TRIPS Agreement and access to medical technologies
send your name, affiliation, address and e-mail address to:
"OPEN LETTER" •••@••.•••
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:
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.
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."I 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. II 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 III . 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.IV
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 Pécoul
Director, Access to Essential Drugs Medicines Project
Médecins Sans Frontiéres
Dr K. Balasubramaniam
Health Action International
James Love
Director, Consumer Project on Technology
ENDNOTES
I -The 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
II -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.
III -Paclitaxel is a treatment for breast and ovarian cancer, and
for Kaposi 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.
IV -To provide a context for this issue, consider the case of
fluconazole, a drug used to treat cryptococcol 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.
Contact Information
Médecins Sans Frontières 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.
Médecins Sans Frontières-Access to Essential Medicines Project
Rue du lac 12
1211 Geneva 6
Switzerland
Tel: + 41 22 8498406
Fax: + 41 22 8498404
E-mail: •••@••.•••
http://www.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: •••@••.•••
http://www.haiweb.org
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: •••@••.•••
http://www.cptech.org
--
James Love / Director, Consumer Project on Technology
http://www.cptech.org / •••@••.•••
P.O. Box 19367, Washington, DC 20036
voice 202.387.8030 / fax 202.234.5176
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