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.

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 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

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.

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.

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.

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.

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,