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1
International Bioethics Conference Oviedo
Convention in Central and Eastern European
Countries
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
Givi Javashvili, Chairman, National Council on
Bioethics National Expert to the Steering
Committee on Bioethics
2
Development of Legal and Ethical Framework of
Human Rights in the Field of Biomedicine in
Georgia
How it evolved in Georgia?
What were contributing factors?
Independence, exposure to universal values human
rights, democracy, autonomy. . .
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
3
Development of Legal and Ethical Framework of
Human Rights in the Field of Biomedicine in
Georgia
How it evolved in Georgia?
How this actually happened?
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. . .
1996 Working group on Health Legislation
drafting framework law for the whole healthcare
system -Law of Georgia on Health Care patients
rights and doctor-patient relationship regulated
first time in Georgia
4
Development of Legal and Ethical Framework of
Human Rights in the Field of Biomedicine in
Georgia
How it evolved in Georgia?
How this actually happened?
1997-98 Group developed into Department of
Health Legislation and Bioethics at the National
Health Management Center. Department/Group
existed until September 2004.
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.
5
Development of Legal and Ethical Framework of
Human Rights in the Field of Biomedicine in
Georgia
How it evolved in Georgia?
How this actually happened?
Reform of Legislation of Georgia in this sphere
started in 1990s (1995-97), before Georgia became
the member of the Council of Europe in 1999. 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.
6
Legislation of Georgia in the Sphere of Human
Rights and Biomedicine
ADOPTED LAST UPDATE
The Law on Health Care 1997 (10.12) 2008 (21.03)
The Law on the Rights of Patient 2000 (05.05) 2007 (08.05)
The Law on Doctors Professional Activity 2001 (08.06) 2008 (21.03)
The Law on Public Health 2007 (27.06) no updates
The law on HIV/AIDS Prevention 1995 (21.03) 2000 (08.11)
The Law on Psychiatric Care 2006 (14.07)1 2008 (01.11)
The Law on Blood Donors and Blood Components 1997 (30.04) 2006 (29.12)
The Law on Human Organ Transplantation 2000 (23.02) 2006 (23.06)
The Law on Drug and Pharmaceutical Activity 1996 (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 Expertise 2001 (07.12) 2007 (16.03)
The Law on Tobacco Control in Georgia 2003 (06.06)
The Law on Biomedical Research Involving Human Subjects Before Parliament Before Parliament
The Law on Reproductive Health and Reproductive Rights Before Government Before Government

7
The Internationally Recognised Documents
Comprising Conceptual Foundations of Health and
Human Rights Legislation of Georgia
The universal Declaration of Human Rights
Nuremberg Code
Declaration Of Helsinki Recommendations Guiding
Physicians In Biomedical Research Involving Human
Subjects World Medical Association
International Code of Medical Ethics World
Medical Association
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
8
The Internationally Recognised Documents
Comprising Conceptual Foundations of Health and
Human Rights Legislation of Georgia
ICH Guideline for Good Clinical Practice
A Declaration on the Promotion of Patients'
Rights in Europe (WHO)
Council of Europe Convention on Human Rights and
Biomedicine and its Additional Protocols
Various Resolutions and Recommendations of
Parliamentary Assembly of the Council of Europe
and Committee of Ministers of the Council of
Europe
9
Difference Legal Implication
Right is the child of law from real laws come
real rights.
Jeremy Bentham 1748-1832, English philosopher
10
Ratification of the Convention on Human Rights
and Biomedicine, and

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

Concerning Transplantation of Organs and Tissues
of Human Origin
Protocol was signed on 25th March, 2002
Was ratified by the Parliament on September 27,
2002
Submitted to Coe on 18 December, 2006
Entered into force on May 1, 2006
12
Ratification of the Additional Protocol to The
Convention on Human Rights and Biomedicine

concerning Biomedical Research
Protocol was signed on 21 February, 2005
Not yet ratified by the Parliament
13
Code of Ethics of Georgian Physician Adopted by
the 1st National Congress of Georgian Physicians
in 2003
Physicians Oath WMA Declaration of Geneva
Constitution of Georgia
Law of Georgia on Doctors Professional Activity
Convention on Human Rights and Biomedicine and
its Additional Protocols
Law of Georgia on Health Care
Law on Georgia on the Rights of Patient
Additional Protocol to the Convention on Human
Rights and Biomedicine concerning Biomedical
Research
The Draft Law on Biomedical Research Involving
Human Subjects
14
Impact of the Oviedo Convention and its Protocols
on Georgian Legislation
Oviedo Convention
The drafting process of various laws took place
before the Convention was signed and ratified.
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.
15
Impact of the Oviedo Convention and its Protocols
on Georgian Legislation
Protocol on the Prohibition of Cloning Human
Beings
The Law on Health Care (adopted in December 10,
1997) prohibits cloning human beings.
The protocol was opened for signature on January
12, 1998. 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).
16
Impact of the Oviedo Convention and its Protocols
on Georgian Legislation
Protocol concerning Transplantation of Organs and
Tissues of Human Origin
Georgian Law on Human Organ Transplantation was
adopted in 2000. 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.

• 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.

17
Impact of the Oviedo Convention and its Protocols
on Georgian Legislation
Protocol concerning Transplantation of Organs and
Tissues of Human Origin
Georgian Law on Human Organ Transplantation was
adopted in 2000. 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.
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
18
Impact of the Oviedo Convention and its Protocols
on Georgian Legislation
Protocol concerning Biomedical Research
The work on ratification of the protocol on
research includes discussion and adoption of the
Law on Biomedical Research on Human Beings.
The first draft prepared in 1999-2000
The draft law has been reviewed by the expert
appointed by the Council of Europe and updated
according to the comments provided in 2001.
Adoption was delayed at the Parliament and the
draft law was reviewed again in 2006-2007 in the
light of the adoption of Additional Protocol
concerning Biomedical Research.
19
Impact of the Oviedo Convention and its Protocols
on Georgian Legislation
Protocol concerning Biomedical Research
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.
20
Legislation of Georgia on Biomedical Research on
Human Subjects
Law on Health Care (10.12.97)
Chapter XIX Biomedical Research
Law on Drug and Pharmaceutical Activity
(25.12.1996)
Chapter III Drug Development and Research ,
Articles 7 and 8
Convention on Human Rights and Biomedicine
(1.03.2001)
Additional Protocol concerning Biomedical Research
Draft Law on Biomedical Research involving Human
Beings
21
Law on Health Care
Drug Law
Draft Law on BMR


Drug Trials

-


Other Research on Human Beings
?

-
Research on Personal Data
Research on Human Bio-materials
?

-
22
Legislation of Georgia on Biomedical Research on
Human Subjects
Shortcomings of Current Legislation
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

• 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.

23
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
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Draft Law on Biomedical Research involving Human
Beings
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
Physical intervention on human being
Research on biological materials which initially
were taken and stored with other purpose
Intervention which doesnt 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
The Law does not apply to research on embryos in
vitro.
25
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 (1891-1974), American Chief Justice
26
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
Information
Informed consent
Confidentiality and privacy
Scientific quality
Minimizing risks and keeping adequate
risk-benefit ratio
Safety
Protection of vulnerable groups
Multidisciplinary review of ethical acceptability
of research protocol and its approval by an
ethics committee
27
Impact of the Oviedo Convention and its Protocols
on Georgian Legislation
Protocol concerning Genetic Testing for Health
Purposes
The were no new developments in this sphere since
the protocol was opened for signatures.

• 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.

28
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.

29
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 Bioethics1, when it reviews
  multicentre and/or international and/or high risk
  research projects
• 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 2003.
• 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.

30
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.

31
International Bioethics Conference Oviedo
Convention in Central and Eastern European
Countries
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
Givi Javashvili, Chairman, National Council on
Bioethics National Expert to the Steering
Committee on Bioethics
32
Draft Law on Biomedical Research involving Human
Beings
Absence of Alternatives
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 doesnt 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.
33
Draft Law on Biomedical Research involving Human
Beings
Quality of research
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 doesnt result in
unacceptable risk or discomfort.
Very detailed list of items to be included in the
research protocol
34
Draft Law on Biomedical Research involving Human
Beings
Research outside the territory of Georgia
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.
35
Draft Law on Biomedical Research involving Human
Beings
Compensation for damage
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.