1. Dr. Igor Codreanu Center of Dialysis and Renal Transplant Republican Clinical Hospital, Chisinau THE IMPACT OF THE OVIEDO CONVENTION ON LEGISLATION IN THE REPUBLIC OF MOLDOVA

2. Human Dignity and Bioethics “Human dignity” – is it a useful concept in bioethics, one that sheds important light on the whole range of bioethical issues, from embryo research and assisted reproduction to biomedical enhancement, to care of the disabled and the dying? Or is it, on the contrary, a useless concept – at best a vague substitute for other, more precise notions, at worst a mere slogan that camouflages unconvincing arguments and unarticulated biases? Edmund D. Pellegrino, M.D. Chairman The President’s Council on Bioethics, Washington, March 1, 2008

3. Convention of Human Rights and Biomedicine in the Republic of Moldova The Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine was signed by the Republic of Moldova on 06 th of May 1997. The Convention was ratified 19 th of July 2002 with the following statement: “In accordance with the article 35 of the Convention, the Republic of Moldova declares that until the reestablishment of the territorial integrity of the state, the stipulations of the Convention could be applied only in the territories controlled by the Government of the Republic of Moldova”. The Convention entered into force in the Republic of Moldova on the 01 st of March 2003.

4. Additional protocols to the Convention in the Republic of Moldova The Additional Protocol to the Convention on Human Rights and Biomedicine, on the Prohibition of Cloning Human Beings was adopted by the Council of Europe and signed by the Republic of Moldova in Paris, on 12th of January 1998. The Protocol was ratified on 19th of July 2002 and entered into force in the Republic of Moldova on the 01st of March 2003. In the context of implementation of the mentioned Additional Protocol, art.144 of the Penal Code of the Republic of Moldova on Cloning which stipulates that human being creation by cloning is punished with prison. In the context of implementation of the mentioned Additional Protocol, art.144 of the Penal Code of the Republic of Moldova on Cloning which stipulates that human being creation by cloning is punished with prison. Point 6 art.9 of the law nr.185, dated 24.05.2001 of the Republic of Moldova on reproductive health care and family planning which stipulates that it is prohibited the use of sexual cells and embryos with the purpose of human being cloning, are in correspondence with its provisions. Point 6 art.9 of the law nr.185, dated 24.05.2001 of the Republic of Moldova on reproductive health care and family planning which stipulates that it is prohibited the use of sexual cells and embryos with the purpose of human being cloning, are in correspondence with its provisions.

5. Additional protocols to the Convention in the Republic of Moldova The Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin was signed by the Republic of Moldova on 08th of February 2007. The Additional Protocol was ratified on 06th of December 2007 and entered into force on the 01st of June 2008. The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes was signed by the permanent Representative of the Republic of Moldova to the Council of Europe on 11th of November 2008. The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research was signed by the Republic of Moldova on 25th of January 2005.

6. The Law no. 263 of 27.10.2005 “The patients rights and responsibilities” Chapter I - General provisions. Strengthening of the fundamental human rights in the field of health services; Strengthening of the fundamental human rights in the field of health services; Recognition of the human life and health as the supreme value; Recognition of the human life and health as the supreme value; Respect for the cultural and moral values of the patient, his religious and philosophical beliefs; Respect for the cultural and moral values of the patient, his religious and philosophical beliefs; If an international treaty to which Moldova is a part establishes other rules than those provided by this law, the rules of the international treaty apply; If an international treaty to which Moldova is a part establishes other rules than those provided by this law, the rules of the international treaty apply; Article 14 - Ensuring patients' rights in the biomedical research Every biomedical research may be conducted only after obtaining written consent of the patient or his legal representative Every biomedical research may be conducted only after obtaining written consent of the patient or his legal representative

7. The Law no. 348 of 14.XII.2005 “The law on the exercise of medical profession” Chapter I - General provisions. Recognition of the human life and health as the supreme value; Recognition of the human life and health as the supreme value; Respect for the patient’ rights and interests, as well as his relatives; Respect for the patient’ rights and interests, as well as his relatives; If an international treaty to which Moldova is a part establishes other rules than those provided by this law, the rules of the international treaty apply; If an international treaty to which Moldova is a part establishes other rules than those provided by this law, the rules of the international treaty apply; Article 13 – Professional secret The doctor is obliged to maintain the professional secret; The doctor is obliged to maintain the professional secret; The information regarding the medical assistance, state of the health, diagnosis and other data obtained during the investigations and treatment are confidential; The information regarding the medical assistance, state of the health, diagnosis and other data obtained during the investigations and treatment are confidential; Article 18 – Relation between doctor and patient Every medical intervention could be performed only after the patient consent, except some urgencies stipulated in the law. Every medical intervention could be performed only after the patient consent, except some urgencies stipulated in the law.

8. The Law no. 35 of 28.02.2008 “The patients mental health” The Council of Europe and European Commission’s Joint Programme for Moldova 2004-2006. The main aim of the new law: Deinstitutionalization Deinstitutionalization To stop stigmatization To stop stigmatization Consent - agreement of the person suffering from mental disorder to be subject to admission procedures, diagnosis and treatment, which must be free from coercion and preceded by a comprehensive information. Community services - a system of care for certain categories of population and based on an integrated mental health services, including outpatient facilities, crisis centers and units of sheltered workshops in general profile hospitals. There are five community centers There are five community centers

9. The Law no. 42 of 06.03.2008 “The transplant of human organs, tissues and cells” The Transplant Agency : Protecting personal rights and freedoms and preventing the sale of human body parts; Protecting personal rights and freedoms and preventing the sale of human body parts; Consent for donation from a deceased body; Consent for donation from a deceased body; Independent Approval Commission Ensuring that the donor: Ensuring that the donor:  Is informed of the procedure and eventual risks;  Has been informed of the illegality of accepting financial benefit for donation;  Is not forced in any way to donate organs, tissues or cells;  Is aware that he may withdraw his consent freely until the start of the donation procedure.

10. Conclusions and next steps The „Regulation on National Ethics Committee for clinical trials” was prepared in accordance with The Additional Protocol to the Convention on Human Rights and Biomedicine The „Regulation on National Ethics Committee for clinical trials” was prepared in accordance with The Additional Protocol to the Convention on Human Rights and Biomedicine The normative acts for the establishment of the Transplant Agency were prepared and has been submitted to the Government The normative acts for the establishment of the Transplant Agency were prepared and has been submitted to the Government The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes will be submitted to the Parliament for ratification in 2010 The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes will be submitted to the Parliament for ratification in 2010 The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research will be submitted to the Parliament for ratification in 2010 The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research will be submitted to the Parliament for ratification in 2010