(2004/C 65 E/244)

WRITTEN QUESTION P-2836/03

by Ulla Sandbæk (EDD) to the Commission

(18 September 2003)

Subject:   HIV and Commission support for development of affordable microbicide

Given the alarming rise of HIV infection in women and girls and the clear need for female-controlled prevention, can the Commission provide an update on how much support it is giving, through different instruments, to support the development of a safe, effective and affordable microbicide?

Answer given by Mr Byrne on behalf of the Commission

(16 October 2003)

The Sixth Framework Programme on Research and Technological Development (2002-2006) within Priority 1 on Life sciences, Genomics and Biotechnology for Health has an action line dedicated to the major communicable diseases linked to poverty.

This action line through two different pillars supports research on microbicides.

Firstly, it supports projects selected through standard call procedures, using the two new instruments (networks of excellence and integrated projects). Two integrated projects on microbicides were evaluated in the first call for proposals and are now in the negotiation phase with the Commission. These projects should run for five years and should develop a second generation of microbicides. One project is designed to create a development pipeline to allow the selection of candidates from a wide range of potentially effective agents.

Another project has a directed approach to bring a specific new class of microbicides to phase 1 clinical trials.

European key players in human immunodeficiency virus (HIV) microbicides field are assembled in these consortia. The integration and complementarity of these two approaches place Europe in a strong strategic position.

Secondly a joint programme with Member States and Norway, the'European and Developing Countries Clinical Trials Partnership' (EDCTP) has just been launchedto develop new clinical interventions against HIV/acquired immunodeficiency syndrome (AIDS), malaria and tuberculosis through a long-term partnership between Europe and developing countries. In the future, clinical trials on HIV microbicides could be tested through EDCTP programme in Africa. Actions under the public health programme of the Community do not foresee, nor are they intended to support, the development of medicinal products.