Oviedo Convention impact for legislation

and practices

Cristina Gavrilovici, MD, PhDRomanian Bioethics Committee

Bratislava, 2009

What does Oviedo Convention represent for romanian legislation?

Law no 17/2001: the ratification of Oviedo Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine

Chapter II - Consent

• Romanian deontology code (for physicians and nurses) (last revision 30.08.2008)

• Law 46/ 21.01.2003: Romanian patients’ rights law

• Law 487/2002: the law of mental health and protection of people with mental health

Chapter III - Private life and right to information

• Law 677/12.12.2001: the law regarding the protection of persons in relation to personal data and the free circulation of these data

• Law 584/29.10.2002: The law regarding the prevention of HIV/AIDS and protection of AIDS/HIV infected people

• The governmental decision related to compulsory introduction of biometric passports

Chapter IV - Human genome

• No romanian law focused on genetics• Additional protocol over genetic testing is

pending to promulgation

Chapter V - Scientific research

• Law no 206/ 27.05.2004: Romanian research law

• The decision regarding the authorisation of clinical trials (non-interventional)

Chapter VI - Organ and tissue removal from living donors for transplantation

purposes

• Romanian transplantation law – still pending

The merits of romanian medical legislation

• Most if not all medical laws in Romania have an important ethical part (which has been subject to debate…before the bill became a law)

The merits of Oviedo Convention

• The launch for many ethical debate and medical legislation at the european level

• It does not bring a definition of PERSON– It merely uses the terms of “human being”

• “dignity, respect, welfare, interest of the human being”

– When it comes to sensitive issues like Chapter III - Private life and right to information, it uses the term “everyone”, with no clue for what “everyone” include (embryos as well???)

The weakness of Oviedo Convention

Conclusions

• It is easier to write a law than to implement a practice

• There is a big gap between legislation and practice

Conclusions

Conclusions