E-drug: Joint MSF/HAI/OXFAM letter to 56th WHA
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In preparation of the 56th World Health Assembly, MSF, OXFAM and
HAI have sent a joint letter to country delegations, writing to present
our concerns related to access to medicines. This issue will be
discussed at the under agenda items IPRs, Innovation and Public
Health and WHO's Medicines Strategy.
Spring Gombe
Global Access Liaison
HAI Europe
Jacob van Lennepkade 334T
1053 NJ Amsterdam
The Netherlands
Phone + 31 20 6833684
Fax + 30 20 6855002
e-mail: spring@haiweb.org
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Geneva,13 May 2003
Re: 56th World Health Assembly
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 Medicines Strategy .
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 Medecins sans Frontieres (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 this R&D;
(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 to date.
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 them.
We look forward to discussing these issues with you at the World
Health Assembly in Geneva.
Sincerely yours,
Ellen t Hoen
Co-ordinator Policy Advocacy and Research
Medecins Sans Frontieres (MSF)
Jeremy Hobbs
Executive director
Oxfam International
Kevin Moody
Co-Director (HAI Europe)
Health Action International
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