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Additional Protocol to the Oviedo Convention concerning Genetic Testing for Health Purposes

Additional Protocol to the Oviedo Convention concerning Genetic Testing for Health Purposes. Laurence Lwoff Bioethics Division Council of Europe 6th Meeting of the European Human Genetics Societies 13 June 2010, Gothenburg, Sweden.

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Additional Protocol to the Oviedo Convention concerning Genetic Testing for Health Purposes

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  1. Additional Protocol to the Oviedo Convention concerningGeneticTesting for HealthPurposes Laurence Lwoff Bioethics Division Council of Europe 6th Meeting of the European Human Genetics Societies 13 June 2010, Gothenburg, Sweden

  2. Council of Europe: activities in the field of bioethics • Council of Europe: intergovernmental organisation set up in 1949 • 47 member states • General objectives: protection of human rights, democratic stability, rule of law and to find common solution to the challenges facing European society • Objectives of activities inbioethics: To protect human dignity and fundamental rights in the field of biomedicine Activities of the Council of Europe: Defining fundamental principles to that end

  3. Genetic tests: ethical concerns • Easier access to « biological intimacy » of individuals Risks for private life of: - person concerned - members of his/her family Risks of discrimination (abusive use by a third party : e.g. employment, insurance)

  4. Problems raised in the field of health • Capacity of analysis greater than capacity to act • Difficulty to understand the implications of the test • Difficulty of interpretation of test results • Risk for private life(person concerned and his/her family) • Persons not able to consent

  5. Additional Protocol concerning Genetic Testing for Health Purposes • Additional Protocol to theConvention on Human Rights and Biomedicine(European patient rights instrument) • Some key points • Quality of genetic testing • Scientific and clinical validity • Clinical utility • Conditions for the offer of a genetic test • Under individualised medical supervision • Information and genetic counselling

  6. Cooperation with ESHG • Elaboration of the Protocol • ESHG recommendations • Expert paperon scientific notions • Implementation • Importance of the cooperationwith the professionals • E.g. Cooperation programmes in member states • Follow up Term of reference: “- to follow developments of the issues addressed in the Additional Protocol concerning Genetic Testing for Health Purposes, in particular in relation to Article 7 – Individualised supervision; - to make proposals to CDBI with a view to facilitate the implementation of its principles. “ Cooperationwith ESHG to that end

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