WRITTEN QUESTION E-1790/99

by Marit Paulsen (ELDR) to the Commission

(11 October 1999)

Subject: Malaria vaccine

Developing countries are in great need of a malaria vaccine. However, the pharmaceutical companies are not very interested, because they would not make enough money from selling their medicines to developing countries.

Could the Commission, as part of its development policy, present a proposal aimed at getting EU Member States to commission pharmaceutical companies to develop a malaria vaccine and to undertake to pay a certain price per dose of vaccine? Such a proposal could result in a vaccine being developed.

Answer given by Mr Nielson on behalf of the Commission

(30 November 1999)

The Commission agrees with the analysis presented by the Honourable Member, but is not necessarily convinced the solution proposed is possible or even effective. The Commission includes below some potential elements for a more feasible strategy.

Malaria kills more than a million people a year and is heavily concentrated in the poorest countries and populations. Recent advances in biotechnology point to a possible malaria vaccine. One would think that this would be high on the agenda of both the international community and the private pharmaceutical firms but for a long time it was not. A recent study found for example that only around US $ 80 million a year is spent on malaria research, and only a very small fraction of that on vaccines. However, malaria and the lack of public and private investment in the development of a vaccine have come more to the fore, thanks to several initiatives of the World health organisation (WHO) and also in the context of the Community's Fifth framework programme for research.

The lack of investment in the research and development of a malaria vaccine is mainly due to the fact that investment in research and development of new technologies is overwhelmingly directed at rich country problems because these countries have the largest profitable markets. A similar situation has also been observed in relation to the lack of investment in an Acquired immune deficiency syndrome (AIDS) vaccine adapted to the developing world strains or public health systems.

The evidence points towards an important challenge, as yet mainly unrecognised, related to the lack of mobilisation of global science and technology to address the crisis of public health in general, and malaria and AIDS in particular, presently confronting the countries with the poorest populations. Therefore creativity and new partnerships are needed to bridge the huge discrepancy between human need, scientific effort and market returns. A beginning of such an approach is presently being discussed within the Community in relation to an AIDS vaccine for developing countries but similar strategies could and should be adapted for malaria. The strategy followed for the AIDS vaccine has several components working in parallel rather than consecutively to gain time, and also to mutually reinforce each other. Some of the main components used at the Community are creating incentives for private industry to invest more in AIDS vaccine research and development for example through the incentives proposed in the orphan drug regulation presently discussed in the Parliament; creating a more credible market in developing countries by ensuring provision for existing vaccines in the national budgets and in the Community aid budgets; creating (together with our main partners) a potential market for the future by pledging financial support for countries to purchase the new vaccine once it becomes available; and increasing support from public sector finance for the research and the development of an AIDS vaccine appropriate for developing countries.

The Community is presently only at the beginning of this approach for AIDS and, if successful co-operation proves possible and fruitful, other initiatives could be envisaged. As indicated by the Honourable Member there is good reason for initiatives of this kind also concerning malaria.

The Commission would add that in the case of malaria, the Community recently increased its support for research and development in the Fifth framework programme through the publication of two calls for proposal (for the constitution of a cluster of Research and development projects on malaria vaccine and for specific research proposals in developing countries). In addition, the Community is also presently financing a demonstration clinical trial in the Gambia in partnership with a pharmaceutical firm.