The Assembly therefore recommends that the Committee of Ministers review thoroughly the text of the draft bioethics convention as transmitted to the Assembly and set out in
8.1 At the end of Article 1, add the following new sentence: "They shall introduce the substantial provisions of this convention into their national legislation."
8.2 In Article 4, add a new paragraph to read as follows: "Services offered to the public involving the use of the biomedical services and techniques shall be subject, in the interest of the protection of the persons concerned, to control of their quality."
8.3 Amend Article 5, paragraph 1, to read as follows: "No intervention may be carried out in the health field without the informed, free, express and specific consent of the person undergoing it."
8.4 Replace Article 6 by the following text: "Interventions may be carried out on persons who have no legal capacity of giving consent and those who, though legally capable of giving consent, have a reduced capacity of understanding, only for their direct benefit and with the consent of their legal representative or an authority or an individual authorised or designated under his national law. A legally incapacitated person may not undergo medical research unless it is expected to produce a direct and significant benefit to his health. Any refusal by the incapacitated person must always be respected. At national level a body (an independent multidisciplinary ethical committee) should be set up to oversee any intervention involving mentally handicapped persons. For the purposes of this convention, "incapacitated persons" means:
persons who have a reduced capacity of understanding;
persons whose capacity to possess rights and to be bound by obligations is limited, either for reasons of age or because of mental illness;
persons having a de facto incapacity".
8.5 In Article 7, at the end of paragraph 2, add the following words: "and also the free and informed consent of the parent(s) or legal guardian(s) is necessary".
8.6 In Article 7, at the end of paragraph 3, add the following words: "and no intervention may be undertaken without their consent."
8.7 In Article 13 the words: "only if this is done in conformity with appropriate information and consent procedures" are to be clarified.
8.8 Delete the first paragraph of Article 15.
8.9 In Article 15, paragraph 2, delete the word "solely".
8.10 Replace Article 16 with the following text: "An intervention on the human genome may only be undertaken for preventive, therapeutic or diagnostic purposes without any intervention in the human germ cell line."
8.11 At the end of Article 18, add the following words: "and in accordance with the national legislation about data protection."
8.12 In Article 20, delete "according to the conditions and procedure prescribed by law".
8.13 In Article 26, paragraph 2 (and elsewhere), replace "European Community" by "European Union"
8.14 In Chapter V, add a new article worded as follows: "For the purpose of observing the application of the convention on the territory of the Contracting Parties and of interpreting the text of the convention, a monitoring body in connection with the European Court of Human Rights is hereby set up".
8.15 In Article 28, paragraph 1, delete "and by the unanimous vote of the representatives of the Contracting States entitled to sit on the Committee of Ministers".
8.16 In Article 30, at the end of the first paragraph, add: "No reservations may be made in respect of Articles 15 and 16."
