Joint Assembly of the Convention concluded between the African, Caribbean and Pacific States and the European Union (ACP-EU) - Resolutions adopted on orphan drugs (ACP-EU/2098/97/fin.)

The ACP-EU Joint Assembly,

- meeting in Brussels from 17 to 20 March 1997,

- having regard to the resolution of the Council of Health Ministers of 30 November 1995 on orphan drugs,

- having regard to the Orphan Drug Act,

A. whereas transmissible diseases in the inter-tropical zone - parasitical, bacterial, mycotic and viral diseases - of which some 5 000 have been identified (80 % being of genetic origin), apart from HIV, which is directly responsible for 7,5 million deaths a year, affect almost 1,5 billion individuals and represent 71 % of the total death rate of countries in this area,

B. whereas the developing countries allocate no more than 4,2 % of their GDP to health, and the health sector accounts for 7 to 8 % of public development aid paid by the OECD countries, funds that are almost exclusively allocated to bridging the many gaps in medical care and organization,

C. whereas while the countries of the inter-tropical zone are continuing to benefit from the medical advances of the last forty years, the extensive growth of chemical resistance, gaps in the range of drugs available and the deterrent cost of new treatments are diminishing and eroding such advances and beginning adversely to affect the level of health in those countries,

D. having regard to the growing difficulties and costs of developing new medicines,

E. whereas 95 % of investment comes from the private sector,

F. whereas 60 to 90 % of the populations and countries affected by these rare diseases (such as botulism, malaria, bilharzia, filariasis, African trypanosomiasis, Chagas' disease, leishmaniasis and leprosy) are seldom able to pay for treatment,

G. whereas the treatment of common illnesses prevailing mainly in the inter-tropical zone is generally unavailable to 3 out of 4 sick people because of their lack of purchasing power and the absence of health protection schemes,

H. whereas priorities in the OECD countries are geared towards controlling health expenditure in the 'profitable diseases` sector, cardiovascular disease, cancer and neuro-degenerative disease, which account for more than 95 % of therapeutic innovation over the last 15 years,

I. whereas the Orphan Drug Act of 1983, which introduced the concept of orphan drugs, presents a largely positive record in the field of rare diseases, but the overall profile of regulatory provisions deriving from it is marked by the sole development of medicines for rare diseases to suit the social and economic context of the industrialized countries, and whereas a similar instrument should be put in place at European level that does not show the same deficiency,

J. whereas the draft European Directive on orphan drugs proposed by the Commission does not include transmissible diseases in the inter-tropical zone in the scope of its definition,

K. whereas the international agencies' (World Bank, WHO and UNDP) TDR programme (Special Programme for Research and Training in Tropical Diseases) has, since 1975, stressed the delays and needs as regards malaria, bilharzia, filariasis, leprosy, trypanosomiasis and leishmaniasis,

L. whereas the Commission's Science and Technology for Development programme (CEC/STD) includes a component for 'scientific and technological development with the developing countries`,

M. concerned that the pharmaceutical industry is moving towards the industry's long-term disengagement from research into tropical transmissible diseases, although these account for the majority of deaths in the countries of that region,

N. worried that progress in molecular medicine is taking practical form only on an experimental basis in the field of vaccination (for bilharziasis, leishmaniasis, malaria and trypanosomiasis) and only in a limited way in the field of treatment,

O. having regard to the difficulties and rising costs of research and development - 1 to 2 billion francs for each new molecule,

P. conscious of and concerned at the dispersion of scientific research teams and the fragmented nature of resources in the absence of an overall generic policy, in particular for the collection and dissemination of information, in both the research and the epidemiological field,

Q. whereas the present epidemics - emergent and re-emergent infectious diseases - are an unfortunate sign of the precariousness of our prevention and treatment structures,

R. whereas between now and the year 2000 not one further molecular innovation will be directly produced by the pharmaceutical industry in the field of tropical medicine, which means depending only on random discoveries, spin-off from veterinary research, the chance analysis of traditional pharmacopoeia or the reassessment of old medicines,

S. whereas there is a more urgent need for activities to improve the practical circulation of medicines than for those affecting the primary supply,

1. Calls for the creation of a special programme for research and development in the field of tropical health, in the form of a task force;

2. Suggests that the programme should be jointly administered by the Commission, an international committee of experts and representatives of the WHO, and the pharmaceutical industry;

3. Wishes this programme to permit the management of a pharmaceutical and clinical database and to be responsible for setting up clinical trials and monitoring them through peripheral establishments, institutes and reference university hospitals in the developing countries;

4. Calls for the Commission to encourage the creation of joint ventures (between industry, universities and/or scientific academies) with the aim of setting up partnership networks;

5. Calls for the creation of a special marketing approval certificate for medicines for tropical diseases;

6. Recommends speeding up the establishment, in collaboration with the WHO and the United States-European Union Task Force, of a monitoring and early warning network for transmissible diseases in the inter-tropical zone and resistance to drugs to combat infections;

7. Instructs its Co-Presidents to forward this resolution to the ACP-EU Council, the Commission and the World Health Organization.