International Bioethics Conference Oviedo Convention in Central and Eastern European Countries Givi Javashvili, Chairman, National Council on Bioethics National Expert to the Steering Committee on Bioethics Impact of Oviedo Convention and its Protocols on Legislation and Practices in Georgia Council of Europe in collaboration with Slovak Medical Association Institute of Medical Ethics and Bioethics n. f September 24-25, 2009 Bratislava, Slovak Republic

Development of Legal and Ethical Framework of Human Rights in the Field of Biomedicine in Georgia Independence, exposure to universal values: human rights, democracy, autonomy... What were contributing factors? Integration into international organizations: UN, COE (1999), etc... Reforms within country: orientation towards western standards Interest of certain groups of professionals within governmental and non-governmental sector How it evolved in Georgia?

Development of Legal and Ethical Framework of Human Rights in the Field of Biomedicine in Georgia How this actually happened? How it evolved in Georgia? 1995: Drafting group on the law on Human Organ Transplantation: first provisions on human rights in the context of healthcare (however, specifically related to organ transplantation): information, consent, etc : Working group on Health Legislation; drafting framework law for the whole healthcare system -Law of Georgia on Health Care: patient’s rights and doctor- patient relationship regulated first time in Georgia

Development of Legal and Ethical Framework of Human Rights in the Field of Biomedicine in Georgia How this actually happened? How it evolved in Georgia? : Group developed into Department of Health Legislation and Bioethics at the National Health Management Center. Department/Group existed until September Products: Laws “on Health Care”, “on the Rights of Patients”, “on Human Organ Transplantation”, “Doctor's Professional Activity”, “Biomedical Research on Human Subjects”, “Reproductive Health and Reproductive Rights”; Preparation for ratification of the instruments of the Council of Europe; Regulations on Ethics Committees etc.

Development of Legal and Ethical Framework of Human Rights in the Field of Biomedicine in Georgia How this actually happened? How it evolved in Georgia? Reform of Legislation of Georgia in this sphere started in 1990s ( ), before Georgia became the member of the Council of Europe in The process of the development of health, biomedicine and human rights legislation in Georgia was greatly exposed to the influence of extensive movement for health care reform in Europe on the national as well as international/regional levels.

Legislation of Georgia in the Sphere of Human Rights and Biomedicine ADOPTEDLAST UPDATE The Law on Health Care1997 (10.12)2008 (21.03) The Law on the Rights of Patient2000 (05.05)2007 (08.05) The Law on Doctor’s Professional Activity2001 (08.06)2008 (21.03) The Law on Public Health2007 (27.06)no updates The law on HIV/AIDS Prevention1995 (21.03)2000 (08.11) The Law on Psychiatric Care2006 (14.07) [1] [1] 2008 (01.11) The Law on Blood Donors and Blood Components1997 (30.04)2006 (29.12) The Law on Human Organ Transplantation2000 (23.02)2006 (23.06) The Law on Drug and Pharmaceutical Activity1996 (25.12)2008 (18.06) The Law on Narcotic Drugs, Psychotropic Substances, their Precursors and Narcologic Care 2002 (05.12)2007 (08.05) The Law on Protection and Promotion of Infant Natural Feeding 1999 (09.09)2000 (09.06) The Law on Medical and Social Expertise2001 (07.12)2007 (16.03) The Law on Tobacco Control in Georgia2003 (06.06) The Law on Biomedical Research Involving Human SubjectsBefore Parliament The Law on Reproductive Health and Reproductive RightsBefore Government

The Internationally Recognised Documents Comprising Conceptual Foundations of Health and Human Rights Legislation of Georgia Declaration Of Helsinki: Recommendations Guiding Physicians In Biomedical Research Involving Human Subjects; World Medical Association; International Code of Medical Ethics; World Medical Association; Nuremberg Code; Principles of Medical Ethics; United Nations; International Ethical Guidelines for Biomedical Research Involving Human Subjects and International Guidelines for Ethical Review of Epidemiological Studies; CIOMS and WHO; The universal Declaration of Human Rights;

The Internationally Recognised Documents Comprising Conceptual Foundations of Health and Human Rights Legislation of Georgia A Declaration on the Promotion of Patients' Rights in Europe (WHO); Council of Europe Convention on Human Rights and Biomedicine and its Additional Protocols; ICH Guideline for Good Clinical Practice Various Resolutions and Recommendations of Parliamentary Assembly of the Council of Europe and Committee of Ministers of the Council of Europe

“Right… is the child of law: from real laws come real rights.” Jeremy Bentham , English philosopher Difference: Legal Implication

Ratification of the Convention on Human Rights and Biomedicine, and Ratified by the Parliament on September 27, 2000 Signed on May 11, 2000 Submitted to Coe on 22 November, 2000 Additional Protocol to The Convention on the Prohibition of Cloning Human Being Entered into force on March 1, 2001

Ratification of the Additional Protocol to the Convention on Human Rights and Biomedicine Was ratified by the Parliament on September 27, 2002 Protocol was signed on 25th March, 2002 Submitted to Coe on 18 December, 2006 Concerning Transplantation of Organs and Tissues of Human Origin Entered into force on May 1, 2006

Ratification of the Additional Protocol to The Convention on Human Rights and Biomedicine Not yet ratified by the Parliament Protocol was signed on 21 February, 2005 concerning Biomedical Research

Constitution of Georgia Law of Georgia on Health Care Laws of Georgia on Drug and Pharmaceutical Activity, on Psychiatry, HIV/AIDS, Human Organ Transplantation etc... Law on Georgia on the Rights of Patient Law of Georgia on Doctor’s Professional Activity Convention on Human Rights and Biomedicine and it’s Additional Protocols Code of Ethics of Georgian Physician Adopted by the 1 st National Congress of Georgian Physicians in 2003 Physician’s Oath WMA Declaration of Geneva Additional Protocol to the Convention on Human Rights and Biomedicine concerning Biomedical Research The Draft Law on Biomedical Research Involving Human Subjects

Impact of the Oviedo Convention and its Protocols on Georgian Legislation The drafting process of various laws took place before the Convention was signed and ratified. Oviedo Convention However, Almost all conceptual statements of the Oviedo Convention are included in Laws on “Health Care”, “Rights of Patients Rights”, “Human Organ Transplantation”, draft “Law on Biomedical Research Involving Human Subject” etc. Therefore, the Convention on Human Rights and Biomedicine and the Protocol on the Prohibition of Cloning Human Being were ratified by the Parliament of Georgia without making any reservation.

Impact of the Oviedo Convention and its Protocols on Georgian Legislation The Law on Health Care (adopted in December 10, 1997) prohibits cloning human beings. Protocol on the Prohibition of Cloning Human Beings The protocol was opened for signature on January 12, However, the Georgian Law was influenced before that date by debates within the Council of Europe around the draft protocol. So, the Georgia could be the first country which prohibited human cloning by law, although the text of the relevant article is not close enough to the language of the protocol - “Human cloning by use of the methods of genetic engineering is prohibited.” (Law on Health Care, Article 142.1).

Impact of the Oviedo Convention and its Protocols on Georgian Legislation Georgian Law on Human Organ Transplantation was adopted in i.e. before the protocol was opened for signature (January 24, 2002). However, the Law incorporated principles of Convention itself, which are aiming at protecting life, health and dignity of organ donors and recipients, particularly vulnerable groups and minimizing the possibility of organ trafficking. Protocol concerning Transplantation of Organs and Tissues of Human Origin Some characteristics of Georgian Law: - “opt-in” system for organ removal from dead donors; - the circle of the living donors is restricted to genetic relatives and spouse of the recipient.

Impact of the Oviedo Convention and its Protocols on Georgian Legislation Georgian Law on Human Organ Transplantation was adopted in i.e. before the protocol was opened for signature (January 24, 2002). However, the Law incorporated principles of Convention itself, which are aiming at protecting life, health and dignity of organ donors and recipients, particularly vulnerable groups and minimizing the possibility of organ trafficking. Protocol concerning Transplantation of Organs and Tissues of Human Origin Later amendment was made to the Law on Human Organ Transplantation, which partly widened the circle of living donors and “donor exchange” was allowed. However, restrictions articulated in the Protocol concerning Transplantation of Organs and Tissues of Human Origin were taken into consideration

Impact of the Oviedo Convention and its Protocols on Georgian Legislation The work on ratification of the protocol on research includes discussion and adoption of the Law on Biomedical Research on Human Beings. Protocol concerning Biomedical Research The first draft prepared in ; The draft law has been reviewed by the expert appointed by the Council of Europe and updated according to the comments provided in Adoption was delayed at the Parliament and the draft law was reviewed again in in the light of the adoption of Additional Protocol concerning Biomedical Research.

Impact of the Oviedo Convention and its Protocols on Georgian Legislation So, the current version of the draft law is in line with the protocol and the Parliament plans to discuss it and start its adoption simultaneously with the Protocol concerning Biomedical Research. Protocol concerning Biomedical Research

Legislation of Georgia on Biomedical Research on Human Subjects Law on Health Care ( ) Chapter XIX: “Biomedical Research” Law on Drug and Pharmaceutical Activity ( ) Chapter III: “Drug Development and Research”, Articles 7 and 8 Convention on Human Rights and Biomedicine ( ) Additional Protocol concerning Biomedical Research Draft Law on Biomedical Research involving Human Beings

Drug Law Law on Health Care Draft Law on BMR Drug Trials Other Research on Human Beings Research on Personal Data  + Research on Human Bio-materials -  +

Legislation of Georgia on Biomedical Research on Human Subjects Law on Health Care: Lacks specificity and does not cover various aspects of biomedical research. Also, it does not give clear guidance about the role and function of research ethics committees Shortcomings of Current Legislation: Law on Drug and Pharmaceutical Activity: - requires ethics committee to be created for each trial at the institution where research is planned to be carried out. - prohibits research on imprisoned individuals and military servicemen. - specifically mentions recommendations set out in WMA Declaration of Helsinki as the basis for conducting clinical trials on human beings.

Draft Law on Biomedical Research involving Human Beings The Structure of the draft Law: Chapter I. General Provisions Chapter II. Principles of Research Project Planning and Implementation Chapter III. Rights of a Research Subject Chapter IV. Responsibilities of a Researcher Chapter V. Research on Specific Groups and/or in Specific Situations Chapter VI. Epidemiological Research Chapter VII. Ethical Evaluation of Research Protocol and Biomedical research Ethics Committees Chapter VIII. Prohibitions Chapter IX-X. Transitional and Final Provisions

The scope: The law concerns any type of research aiming at obtaining information and broadening knowledge in the sphere of biomedicine which serves the interests of human health protection and implies: The Law does not apply to research on embryos in vitro. Physical intervention on human being; Research on biological materials which initially were taken and stored with other purpose; Intervention which doesn’t imply physical intervention on human being but can pose danger to mental health or psychological condition of human being; Research on foetus and/or embryo in vivo; Draft Law on Biomedical Research involving Human Beings

The core principles the legislation is based on: “In civilized life, law floats in a sea of ethics.” Earl Warren ( ), American Chief Justice Draft Law on Biomedical Research involving Human Beings

The core principles the legislation is based on: Primacy of the human being Autonomy of research subjects Scientific quality Minimizing risks and keeping adequate risk-benefit ratio Protection of vulnerable groups Multidisciplinary review of ethical acceptability of research protocol and its approval by an ethics committee Information Informed consent Confidentiality and privacy Safety Draft Law on Biomedical Research involving Human Beings

Impact of the Oviedo Convention and its Protocols on Georgian Legislation The were no new developments in this sphere since the protocol was opened for signatures. Protocol concerning Genetic Testing for Health Purposes However, the Laws on “the Rights of Patients” and “Health Care” include specific provision on Genetics, which are coherent to the principles established by the Convention. These provisions concern:  non-discrimination;  general conditions to perform gene therapy;  general conditions to perform genetic testing;  restrictions for the interventions seeking to modify the human genome;  prohibition of sex selection.

Impact of the Oviedo Convention and its Protocols on Practices in Georgia  National Council of Bioethics regularly refers to the Oviedo Convention and its Protocols in the process of making decisions and recommendations on specific issues ( human organ transplantation, stem cells, end of life, palliative care and euthanasia, psychiatry etc.)  Georgian Government based on the Convention and its Anti- cloning Protocol made its decision during international debates on UN level concerning prohibition of human cloning.  The Oviedo Convention is used in the process of education/training of health care professionals and lawyers.  Association of Transplantologists of Georgia considers the Convention and additional Protocol concerning Transplantation of Organs and Tissues of Human Origin in decision-making process.

Impact of the Oviedo Convention and its Protocols on Practices in Georgia  Additional Protocol concerning Biomedical Research as well as Oviedo Convention itself are intensively used in the process of ethical review of research projects, which involve human beings. This is done by:  National Council on Bioethics[1], when it reviews multicentre and/or international and/or high risk research projects;[1]  Local research ethics committees.  Provisions of the Convention have been reflected in the Code of Ethics of Georgian Physicians, which has been developed and endorsed in [1][1] Usually National Council on Bioethics does not review specific research projects, unless specifically requested; particularly, when projects are multicenter/international or there is comparatively high risk associated with the research project.

Impact of the Oviedo Convention and its Protocols on Practices in Georgia  However, the Oviedo Convention and its additional Protocols are not widely known, referred and/or followed by relevant professionals – health care providers, lawyers, policy makers. More efforts are needed for their popularization. Such efforts should include development and implementation of specific modules to teach the above instruments of the Council Europe on undergraduate as well as postgraduate level for health care professionals and lawyers.

International Bioethics Conference Oviedo Convention in Central and Eastern European Countries Givi Javashvili, Chairman, National Council on Bioethics National Expert to the Steering Committee on Bioethics Impact of Oviedo Convention and its Protocols on Legislation and Practices in Georgia Council of Europe in collaboration with Slovak Medical Association Institute of Medical Ethics and Bioethics n. f September 24-25, 2009 Bratislava, Slovak Republic

Absence of Alternatives Draft Law on Biomedical Research involving Human Beings A research shall be carried out on a person in case if there is no alternative method of research with analogous scientific value the subjects of which are not human beings. Risks and Benefits Risk and discomfort related to participation in research shall not exceed benefit of a research. Benefit can concern a research subject as well as other persons. Concept of Minimal Risk Risk, which doesn’t exceed risks associated with diagnostic and therapeutic intervention of daily practice and when it is expected that negative impact of the intervention is insignificant and temporary.

Quality of research Draft Law on Biomedical Research involving Human Beings Any research shall be scientifically valid, shall meet recognized requirements for scientific research and be carried out under supervision of a relevantly qualified researcher. Placebo Use of placebo in a research is permitted when there is no approbated method with relevant efficiency or when withholding such an approved method or its withdrawal doesn’t result in unacceptable risk or discomfort. Very detailed list of items to be included in the research protocol

Research outside the territory of Georgia Draft Law on Biomedical Research involving Human Beings If a researcher or a sponsor, who is on the territory of Georgia plans to carry out a research outside the country, he/she shall ensure development of a research protocol and its implementation in a way that the guarantee for protection of a research subject shall not be weaker than guarantees determined by the present law and other relevant Georgian legislation. Financial issues No financial or any type of compensation with the aim of obtaining informed consent. Reimbursement of expenses or financial damages related to participation in research. Possibility of free of charge medical services in those medical institutions where a research is carried out for which consent of ethics committee is necessary.

Compensation for damage Draft Law on Biomedical Research involving Human Beings When participation in research causes damage to research subject or his/her death compensation is issued by a researcher or a research sponsor; A researcher can insure a research subject against possible damage or death incurred from a research. In this case compensation is issued by an insurance company. Contract Contract should reflect (a) responsibilities of a researcher, (b) responsibilities of a research subject, (c) entity issuing compensation in case of damage, (d) entity responsible for reimbursement of expenses related to participation in research.