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Biotechnology developments and human health

Objective

Specific Objectives:
1. To organise an expert workshop to assess the scenarios for genetic services harmonisation in the EU and to set the basis for a European network for genetic testing (reference system and quality assessment);
2. To complete the prospective study "Genetic Testing Services Quality Assurance and Harmonization in the EU: Technical needs and options";
3. To launch a study on pharmacogenomics - personalised medicine;
4. To organise a workshop to disseminate and discuss results of the Genetic Testing study to the scientific community, EU services and representative stakeholder (September 2003);
5. To complete the prospective study "Human tissue-engineered products: Today's market and future prospects" (May 2003);
6. To organise a workshop to disseminate the results of the Tissue Engineering study to the scientific community, Commission services and stakeholders (November 2003);
7. On request, to perform short studies (information-collection) and write background documents for GOPA to be used by the EGE (all 2003) Anticipated milestones and schedule 1.1 Expert workshop on scenarios for genetic services harmonisation in the EU (January 2003) 4.1 Workshop to disseminate and discuss results of the Genetic Testing study (September 2003) 6.1 Workshop on Tissue Engineering (November 2003).
Planned Deliverables:
1.1 Expert workshop on scenarios for genetic services harmonisation in the EU (January 2003);
2.1 Peer-reviewed report on Genetic Testing Services Quality Assurance and Harmonization in the EU: Technical needs and options; a report from a pilot survey performed in Spain (as a case-study) and OECD data produced in collaboration will also be included (May 2003);
4.1 Workshop to disseminate and discuss results of the Genetic Testing study (September 2003);
5.1 Peer reviewed report on Human tissue-engineered products: Today's market and future prospects (July 2003);
6.1 Workshop on Tissue Engineering (November 2003);
7.1 Ad hoc short studies and background documents for the EGE (throughout 2003).

Output Indicators and Impact Potential input in the proposed legislative framework for human tissue engineering and tissue engineered products (specifically the future directive on tissue engineering) Impact on research priorities: the genetic testing reference system has been included among highly relevant topics in the thematic priority "Genomics and Biotechnology for Health" Visible input on the next EGE opinion on the ethical aspects of biomedical research in Developing Countries.
Summary of the Action:

This action will have four main areas of involvement in 2003, prioritised according to the specific requests made by Commission services (DG RTD, DG ENTR, GOPA): To identify research needs and options for harmonisation of genetic testing services in an enlarged EU. On the issue of genetic testing, there is no formalised external quality system or scheme that can guarantee that a person is getting the correct results, the proper counselling and a referral to the most adequate centre for the particular genetic test s/he is undergoing. This issue is relevant for health policy, consumer protection and business regulation, as shown by the interest of DG SANCO, ENTR and RTD. Commercialised genetic testing kits clearly fall under the scope of the IVD Directive (98/79/EC) but this is not the case for home-brewed tests and nor for the other aspects of the service (counselling, access, reporting the results, etc). The specific problem of genetic testing of rare diseases could be encompassed by the programme of Community action on rare diseases within the framework for action in the field of public health (1999 to 2003) (DECISION No 1295/1999/EC).

The study will also cover Candidate Countries. This action will also catalyse a proposal for a Network of Excellence in genetic testing. Support to the new Directive on Tissue Engineering. The tissue engineering (TE) industry is expected to grow considerably but specific regulatory mechanisms for TE products in the EU are still absent. This creates a major challenge for the development of this industry. As stated by the Scientific Committee on Medicinal Products and Medical Devices in its opinion of October 1, 2001, neither the medical devices approach nor the medicinal product approach is applicable to TE. To address this issue, the European Commission is preparing a directive to cover engineered human tissue products to harmonise legislation in the EU and to create a common European market while safeguarding consumer protection. This action will provide a comprehensive picture of the state-of-the-art of tissue engineering in the enlarged EU in terms of research activities, actual market-industry structure and probable future market and technology developments.

To prepare background documents for the European Group on Ethics in Science and New Technologies (EGE). The group is an independent committee advising the Commission on the ethical implications of science and new technologies, either at the request of the Commission, the EP and the Council, or on its own initiative. The secretariat of the group has been requesting help in the form of background documents for the EGE. Such documents are presented by the JRC during the EGE sessions. Personalised medicine: pharmacogenomics and issues for public health systems. The shift from traditional drug design ("one size fits all") to personalised medicine design and treatment, supported by the new advances in pharmacogenomics, is a radical change in medicine. Pharmacogenomics research correlates the genetic makeup of individuals with their response to different medicines. This will eventually lead to diagnostic tools but will also raise issues of equal accessibility, cost for health systems, and other possible controversial issues such as information misuse. The derived socio-economic impacts need to be assessed.

Rationale:
Developments of technology in the post-genome era have brought about new prospects in diagnosis and therapy. Amongst others, the booming of genetic testing and the unexpected new possibilities of engineering and replacing tissue and organs are noticeable. However, technologies develop so fast that it is hard for policy makers to cope with the arising socio-economic issues. In the context of the JRC mission of policy support and anticipation, this action is to analyse developments in the area of biotechnology and their impacts in the health sector in an enlarged EU society, trying to flag in advance potential demands and policy needs.

Coordinator

Institute for Prospective Technological Studies
Address
Edificio Expo, C/ Inca Garcilaso S/n
E-41092 Seville
Spain