E-MED: 56ème Assemblée Mondiale de la Santé
La Cinquante-Sixième Assemblée mondiale de la Santé se tiendra du 19 au 28
mai 2003 au Palais des Nations, Avenue de la Paix, Genève (Suisse). Les 192
Etats Membres de l'Organisation mondiale de la Santé (OMS) se réunissent
chaque année pour cette Assemblée. En 2003, les temps forts en seront la
nomination du nouveau Directeur général et l?adoption éventuelle de la
convention-cadre pour la lutte antitabac, le premier traité mondial conclus
par l?OMS. L?Organisation prévoit de faire des points de presse quotidiens
sur les principales questions internationales de santé publique, notamment
sur le SRAS et l?émergence des épidémies mondiales, la lutte antitabac, les
défis sanitaires en Iraq après la guerre et la prévention de la violence
Lettre aux délégations qui assisteront l'Assemblée Mondiale de la Santé de
HAI, MSF et Oxfarm
Geneva,13 May 2003
Re: 56th World Health Assembly
To: WHO member country delegations
MSF, Oxfam and HAI are writing to present our concerns related to access to
medicines. This issue will be discussed at the 56th World Health Assembly
(WHA) under agenda items ?IPRs, Innovation and Public Health? and ?WHO?s
IPRs, Innovation and Public Health (agenda item 14.9)
There is an urgent need for new vaccines, diagnostics, and treatments to
address high mortality and morbidity associated with infectious disease. The
current system of motivating research and development favours the needs of
people in developed countries, while neglecting many diseases that primarily
affect people in developing countries.
Of the 1,393 new medicines marketed in the last 25 years, only 16 were for
tropical diseases and tuberculosis. Even research in areas such as HIV/AIDS
is not meeting the specific needs of people in developing countries. This is
reflected in the dearth of development of diagnostic tests that can be used
in resource-poor settings and of certain fixed dose combinations of ARVs.
The present system of stimulating innovation with intellectual property
protection has created a fatal imbalance between global R&D needs and
spending. The 56th WHA is the place to discuss new approaches for a system
that will allocate more R&D resources to developing countries? health needs.
As a WHO member state you have the ability to ensure that WHO addresses this
critical issue. We urge you to support WHO?s active engagement in the R&D
challenge by mandating it to explore systemic change to drive new resources
towards meeting real health needs.
We seek your support for the proposal for an international convention that
emerged from an international meeting on R&D held in Geneva on April 29th
and organised by Médecins sans Frontières (MSF), Consumer Project on
Technology (CPTECH), Health Action International (HAI), OXFAM and the Third
World Network (TWN).
The proposal recommends that the WHO begin discussions on an international
convention aimed at stimulating essential health research and development.
This convention would:
(1) Define a needs-driven international R&D priority agenda;
(2) Commit all countries to contribute to R&D for health;
(3) Outline an agreement and clear rationale for sharing the cost burden of
(4) Define appropriate funding and incentive mechanisms so that governments
can fulfil their commitments to public sector involvement in R&D;
(5) Establish and strengthen international mechanisms for exchanging and
transferring research results, knowledge and technology;
(6) Ensure developing countries? central involvement in R&D.
WHO medicines strategy (agenda item 14.8)
(1) Implementation of the Doha Declaration on TRIPS and Public Health
The WTO?s failure to resolve the Doha Declaration?s ?paragraph 6? issue
highlights the need for WHO?s involvement now more than ever. In Doha, WTO
Members agreed to find a solution to allow production of medicines for
export to countries that do not have production capacity. The deadline for
finding a solution was the end of 2002. We urge you to help reinvigorate the
WHO?s proposal made at the WTO TRIPS Council on September 17 2002 for a
workable and economically viable solution to the paragraph 6 problem.
WHO?s involvement in the trade and medicines issue will be crucial as the
TRIPS 2005 deadline nears, date at which countries will lose their ability
to produce, sell and export generic versions of new medicines. Vital
questions regarding access to medicines should not be left to the trade
negotiators at the World Trade Organisation. What is the point of extending
the least developed country deadline for TRIPS compliance for pharmaceutical
patents to 2016 if sources of affordable generics are allowed to dry up?
We urge you to insist that the WHO has a stronger voice in trade discussions
in general, and specifically ensure that any Paragraph 6 solutions meet the
WHO criteria for a workable and economically viable solution.
We strongly recommend that the WHA discuss mechanisms to ensure access to
affordable medicines after TRIPS has been fully implemented.
There has never been a more critical time for WHO to intensify its technical
support on the trade and medicines issue. Technical assistance should
include help to countries to ensure that their national patent legislation
includes the maximum flexibility as defined by the Doha Declaration on TRIPS
and Public Health.
In its progress report on the Medicines Strategy (A56/16), WHO highlights
differential pricing as a way to improve affordability of essential
medicines. While we support an international system of differential pricing,
current differential prices are ad hoc offers that rely solely on the
goodwill of companies. Furthermore, these price cuts have been in response
to generic competition, which will cease to exist for new drugs after 2005.
We recommend that WHO advocate that differential pricing become more
systematic. Differential pricing must be part of a wider policy package,
which includes measures to enhance generic competition, such as voluntary
and compulsory licensing, and patent exceptions.
2) Manual for surveying medicine prices
We welcome the WHO/HAI manual for surveying medicine prices, which is a
result of the WHO NGO roundtable process. This will be an invaluable tool
for member states, NGOs and WHO to monitor drug prices, make price
comparisons between countries and monitor the effects of TRIPS
implementation over time.
3) Pre-qualification of low-cost medicine producers
We commend WHO?s work on the pre-qualification of medicines for HIV/AIDS,
and acknowledge the positive impact the programme has had on access to
quality generics in developing countries.
However, the ad hoc nature of this project and the lack of adequate funding
have prevented the programme from reaching its full potential. For example,
no producers of drugs for tuberculosis and malaria have been pre-qualified
Pre-qualification is also crucial for recipients of grants from the Global
Fund to fight AIDS, TB and Malaria, because the Fund will require that
grantees purchase pre-qualified drugs by the end of 2004.
Although pre-qualification needs to be strengthened, it will never be a
substitute for national drug authorities. It is designed to help national
authorities and other procurers to make sound decisions.
We urge you to support transformation of the pre-qualification project from
an ad hoc activity to a full-fledged permanent function of the WHO Essential
Drugs and Medicines Policy programme (EDM). We also urge you to make
additional technical and financial resources available to enable the WHO to
speed up and expand this work to include other essential medicines.
If WHO?s pre-qualification work is not fully supported, it could have the
unintended effect of limiting the sources of medicines rather than expanding
We look forward to discussing these issues with you at the World Health
Assembly in Geneva.
Ellen ?t Hoen
Co-ordinator Policy Advocacy and Research
Médecins Sans Frontières (MSF)
Co-Director (HAI Europe)
Health Action International
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