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Specific research and technological development programme (EEC) in the field of biomedicine and health, 1990-1994

Part of the third framework programme for Community activities in the field of research and technological development (1990 to 1994) under subactivity II.4.: "Life sciences and technologies", the programme builds on and continues work carried out under the fourth Medical and Health research programme (1987-1991) and the Human Genome Analysis programme (1990-1992). Close coordination will be maintained with other relevant research programmes, including "Biotechnology", "Life sciences and technologies for developing countries" (STD III), "Telematics systems in areas of general interest" (area 3: "Health care"), "Medical research" under the European Coal and Steel Community Treaty, and the "Europe against cancer" programme.

The principle of subsidiarity will be applied to the maximum. Harmonization of the approaches and methodologies used in different national programmes will be encouraged. The projects within the programme will have a European dimension based on research networks. Strengthening of networks, particularly by the establishment of "European laboratories without walls", will aim at the development of specific and competitive subject areas. Mobility of research workers between participating laboratories will be encouraged, including for short periods of time. Harmonized methods, specific to the relevant protocols, will ensure that the data resulting from the projects carried out throughout the Community can be analysed and exploited anywhere in the Community. Coordination of national activities will ensure effective use of resources.

The main focus will be on new approaches to tackling economically and socially significant diseases (in particular AIDS, cancer, cardiovascular disease and mental illness), the ageing process, and age-related problems and handicaps, through the harmonization of methodologies and protocols in epidemiological, biological, clinical and technological research. Activities will also cover the analysis of the human genome and will be closely coordinated with the work done elsewhere on the other genomes. Caution will be exercised and particular attention will be paid to the ethical, social and legal aspects of the work, especially those which may be linked to possible misuses of research findings.

Attention will also be paid to methods of early screening for risk factors, to the development and assessment of prophylactic and therapeutic methods and to the management of health services.
To contribute to improving the efficacy of medical and health research and development in the Member States, in particular by better coordination of their research and development activities and application of the results through Community cooperation and a pooling of resources.
Four areas:

- Development of coordinated research on prevention, care and health systems (harmonization of methodologies and protocols in epidemiological, biological and clinical research):
. Pre-competitive drug testing, with a view to improved harmonization of norms and parameters, and research into the monitoring and surveillance of drug prescribing practices, patient compliance and the incidence of adverse drug reactions;
. Research into risk factors, especially in the context of occupational medicine, with a view to the identification of potential risk factors and the early detection of disease;
. Biomedical technology: development of coherent systems and procedures for diagnosis, therapy, prevention, care and rehabilitation, coordination of basic research (modelling) and applied technological research;
. Support to multi-centre studies between countries which might pave the way for the granting of patents and authorizations for the marketing of new medicinal products;
. Emphasis on the harmonization of protocols and approaches in health services, particularly with Europe 1992 in view;

- Major health problems and diseases of great socio-economic impact:
. AIDS: Disease prevention, basic research, clinical research, development of a European vaccine against AIDS (EVA), trials of antiviral drugs in AIDS management (ADAM);
. Cancer: Genomic and phenotypic changes in cancer cells and immune surveillance, improved methodologies, links between risk factors and the incidence of cancer, paediatric cancerology;
. Cardiovascular diseases: Correlation between genetic factors, lifestyle, nutrition, and the incidence and development of cardiovascular disturbances, the effect of prophylactic and therapeutic measures, the development of non-invasive methods of diagnosis, and the testing of drugs;
. Mental illness and neurological disease: Aetiological factors and predisposing conditions, aetiopathogenic mechanisms, enzymology, neuroendocrinology, genetics, psychosocial phenomena during the development of diseases;
. The ageing process and age-related health problems and handicaps: Perinatal and paediatric illnesses, effectiveness of prophylactic and therapeutic measures, ageing in different social settings, specific pathologies relating to ageing, dysfunction and decrease in functional capacity, organ transplant methods, effects of the environment;

- Human genome analysis:
Aimed at the completion and the integration of the genetic and physical maps, with continuing emphasis on the study of the genetic basis for biological functions as well as the setting up of a coordinating mechanism to sequence portions of the genome of major biological interest;

- Research on biomedical ethics:
. Evaluation of questions of biomedical ethics linked with the present research programme;
. Evaluation of the social impact of the programme and the risks (including technological risks) which may be associated with it.
The Commission is responsible for the implementation of the programme, assisted by a committee of an advisory nature composed of representatives of the Member States and chaired by a representative of the Commission.

The programme comprises research and technological development (RTD) projects, accompanying measures and concerted action.

The projects are the subject of shared-cost contracts. Community financial participation will not normally be more than 50%. Universities and other research centres have the option of requesting, for each project, either 50% funding of total expenditure or 100% funding of the additional marginal costs. Contracts relating to shared-cost research projects must as a general rule be concluded following a selection procedure based on calls for proposals published in the Official Journal of the European Communities. Projects must, as a general rule, provide for the participation of at least two partners, each independent of the other, established in different Member States.

Research contracts relating to human genome analysis (improvement of human gene mapping) must guarantee that members of the families involved are kept fully informed and consent to the use and study of their DNA. They must also guarantee full confidentiality and anonymity of personal data. No research modifying, or seeking to modify, the genetic constitution of human beings by alternation of germ cells or of any stage of embryo development which may make these alterations hereditary will be carried out under this programme.

The accompanying measures consist of:
- The organization of seminars, workshops and scientific conferences;
- Internal coordination with the help of integrating groups;
- Advanced technology training programmes, with emphasis being placed on multidisciplinarity;
- Promotion of the exploitation of results;
- Independent scientific and strategic evaluation of the operation of the projects and the specific programme.

Concerted action consists of action by the Community to coordinate the individual research activities carried out in the Member States. Such action may receive funding of up to 100% of coordinating expenditure.

The Commission is authorized to negotiate, in accordance with Article 130n of the Treaty, international agreements with third country members of COST, in particular member countries of the European Free Trade Association (EFTA) and Central and Eastern European countries, with a view to associating them with the whole programme or a part of it and, as regards Area 3 (Human genome analysis). with other third countries and international organizations with a view to associating them with the whole programme. Bodies and enterprises established in non-Community European States may, on the basis of the criterion of mutual benefit, be allowed to become partners in a project undertaken within the programme. For projects in Area 3, this option may be extended to bodies and enterprises from other non- Community countries engaged in research in the area.

No contracting party based outside the Community and participating as a partner in a project undertaken within the programme may benefit from Community financing for this programme. Such partner shall contribute to the general administrative costs.

The Community funds estimated as necessary for the execution of the programme amount to ECU 151 million, of which a sum amounting to 1% of the budget is earmarked as the contribution from the programme to the centralized scheme for the dissemination and exploitation of results. Of the total, a sum of ECU 25 million is reserved for AIDS research. 5% of the total will be allocated to training research workers and specialists.

The knowledge gained in the course of the projects will be disseminated both within the programme and by means of the centralized scheme.

The Commission will review the programme during the second year and send a report to the European Parliament and the Council. At the end of the programme an evaluation of the results achieved will be conducted by a group of independent experts and submitted to these same bodies.