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Genetic Testing for Familial/Hereditary Breast Cancer - Comparison of Guidelines and Recommendations from the United Kingdom, France, the Netherlands and Germany

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Survey on genetic testing and use of genetic information EUROPEAN COMMISSION Directorate General: RESEARCH Survey on national legislation and activities in the field of genetic testing in EU Member States Edited by Line MATTHIESSEN-GUYADER 1 May 2005 Directorate E Biotechnology, Agriculture and Food 2 EUROPEAN COMMISSION RESEARCH DIRECTORATE-GENERAL Directorate E - Biotechnology, agriculture and food The Director INTRODUCTION Genetic testing, its scientific, ethical, legal and social implications, has continued to be subject to debate both nationally and internationally. Discussions on the need or in some cases review of existing legislations or preparation of new legislation have been initiated across Europe. OECD is also active in this field and is preparing guidelines on quality assurance of genetic testing. The European Commission has in its 2nd progress report on “Life Sciences and Biotechnology – a Strategy for Europe” 1, published on 6 April 2004, highlighted that “the various activities undertaken regarding genetic testing at European and international level have indicated the need for a co-ordinated approach on this emerging field within the Commission services and with the Member States”. The report identifies the following priorities for future activities to be undertaken by the European Commission and Member States: - to engage in EU-wide co-ordination of efforts to ensure the highest quality of genetic testing in the EU and beyond; - to establish an EU- wide networking of national centres for exchange of information regarding quality assurance of genetic testing including training activities, and an EU- wide networking for genetic testing of rare diseases. Without any intention to interfere with Member States’ competence regarding genetic testing, DG Research has established an informal working group involving officials and

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