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Oviedo Convention and its Protocols Impact on Legislation and Practices in the Slovak Republic

International Bioethics Conference Oviedo Convention in Central and Eastern European Countries September 24 – 25, 2009, Bratislava, Slovakia. Oviedo Convention and its Protocols Impact on Legislation and Practices in the Slovak Republic. Jozef Glasa IPCP SMU, IMEB n. f., EC MH SR,

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Oviedo Convention and its Protocols Impact on Legislation and Practices in the Slovak Republic

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  1. International Bioethics ConferenceOviedo Convention in Central and Eastern European Countries September 24 – 25, 2009,Bratislava, Slovakia Oviedo Convention and its Protocols Impact on Legislation and Practices in the Slovak Republic Jozef Glasa IPCP SMU, IMEB n. f., EC MH SR, Bratislava, Slovak Republic

  2. Developments in the Slovak Republic 1990-2009(1) • 1990 - Central Ethics Committee (CEC; MH SR) • 1991/2 - (Research) ethics committees in research institutions and major teaching/university hospitals • 1991 - Chair of Medical Ethics (postgraduate level) • 1992 - Institute of Medical Ethics and Bioethics (undergraduate & postgraduate level ‘bioethics’ education) • 1992 - Guidelines on establishment and work of ethics committees(prepared by CEC; MH SR) • 1991-3 - several national & international bioethics conferences • 1993 - Institute of Medical Ethics and Bioethics Fdn. • 1994 - journal “Medical Ethics & Bioethics” • 1994 - new Health Law (No. 277/1994 Coll.) – incl. RECs • 1998 - Law on Drugs (140/1998 Coll.) – incl. RECs

  3. Developments in the Slovak Republic: 1990-2009(2) • 2002 - new CEC appointed • 2002 - Program of revitalisation of the system of ethics committees in the Slovak Republic (by CEC) • 2002 - Draft Regulation on ethics committees (by CEC) • 2002-8 - 1st – 7th national meeting of (R)ECs (sponsored by CEC) ––––– SLOVAK REPUBLIC ENTERING EU ––––––––––––––––––––– • 2004 -new Health Law (576/2004 Coll.) and substantial amendments of Law on Drugs (No. 140/1998 Coll.) • 2004 - Guidelines on application for CTs by the State Institue for Drug Control (SIDC) (No. 7/2004) • 2005-8 - several amendments of Health Law & of Law on Drugs • 2005-8 - amendments to Guidelines by SIDC (No. 7/2008) • 2006-8 - amendments of the Law on Drugs (Dir. 2005/28/EC, etc.) What’s next: • ministerial regulation on (R)ECs (2009?)

  4. Oviedo Convention and its Protocols Impact on Legislation and Practices in the Slovak Republic (1) • after breaking down the „Iron Curtain“ (November 1989) – unprecedented social, economical, cultural developments: „Velvet Revolution“ in Slovakia/CSR/CEE • several attempts to reform the health care system • developments at universities, in the research sector, especially in humanities (ML → other philosophies,…) • many attempts to reform or re-write health/biomedical legislation (1994, 1997, 2004,…???) • integration of research in SR into European/Global arena • looking for “mental support”, expertise - especially when developing legislation and “soft law” instruments in newly developed areas (research, transplantation, cell medicine, genetics,…) • most of health care-/biomedicine-related legislation developed at the Ministry of Health (Department of Law, NEC) • other bodies – soft law documents: Medical Chamber, SMA, scientific societies, National Research Agency (APVV), churches

  5. Oviedo Convention and its Protocols Impact on Legislation and Practices in the Slovak Republic (2) • new health legislation in Slovakia – 2004 (and its later amendments) • Law No. 576/2004 on health care • Law No. 578/2004 on health care providers • Law No. 140/1998 on medicinal drugs • LawNo. 576/2004 on health care: • informed consent • biomedical research (incl. “special situations”) • ethics committees • transplantation, organ/tissue donation • patients’ rights N.B. Some bioethical issues excluded (e.g. assisted reproduction, some issues in genetics, cloning (included in the previous L.)).

  6. Oviedo Convention and its Protocols Impact on Legislation and Practices in the Slovak Republic • development of laws + “soft law”: debate, politics, media,.. • development of medical ethics, ethics in nursing, bioethics, ethics of public health, ethics in various medical disciplines • dealing with ethical dilemmas in everyday’s practice • education: health professionals, researchers, administrators (MPH), scientists (undergraduate, postgraduate) • “embedding ethics” in various other disciplines/fields • ethics committees (“national”, research, “hospital”/clinical ethics) • creating the R/ECs system • improving/monitoring its performance • ethics versus bureaucracy • clinical trials: Good Clinical Practice – legislation, good practices, education, training, new dilemmas • public debate, ethics / religion education in school

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