Dubravka šimonović Ana borovečki Impact of the Oviedo Convention and its Protocols on national legislation and practices in biomedical field in Croatia Dubravka šimonović Ana borovečki

Croatia and the Oviedo Convention in 1995 the Republic of Croatia started to follow the work of the Steering Committee on Bioethics (CDBI) as an observer in the Council of Europe on 6 November 1996 the Republic of Croatia joined membership of the Council of Europe on May 7, 1999 Croatia signed the Oviedo Convention and the Additional Protocol on the Prohibition of Cloning of Human Beings in Budapest, Hungary on July 14, 2003 Croatian Parliament ratified the Oviedo Convention and the Additional Protocol on the Prohibition of Cloning Human Beings and the Additional Protocol to the Convention on Transplantation of Organs and Tissues of Human Origin

Croatia and the Oviedo Convention since its ratification the Oviedo Convention has formed part of the internal legal system of the Republic of Croatia (Article 140 of the Croatian Constitution declares:„ International agreements concluded and ratified in accordance with the Constitution and made public, and which are in force, shall be part of the internal legal order of the Republic of Croatia and shall be above law in terms of their legal effects.“ ) courts apply international treaties directly when they decide on issues concerning the protection of human rights of an individual (Article 5 of the Courts Act (OG 150/2005) provides: „Courts rule according to the Constitution and the laws. Courts also rule according to the international treaties which are part of Croatian legal order. “)

Croatia and the Oviedo Convention the Republic of Croatia made one reservation regarding Article 20 of the Convention on Human Rights and Biomedicine dealing with the protection of persons not able to consent to organ removal Croatia made its reservation to this article, because in the Republic of Croatia the removal of regenerative tissue (like bone marrow) is permitted in the cases of donation from a minor to parents by the Law on Retrieval and Transplantation of Human Body Parts for Medical Treatment as amended in 2009

Croatia and the Oviedo Convention numerous laws adopted after the ratification of the Oviedo Convention and its Additional Protocols in the legislative process they are aligned with the relevant provisions of the Oviedo Convention and its Additional Protocols - the 2004 amendments to the Criminal Code (prohibitions and sanctions for the cloning of a human beings) the 2009 Croatian Anti-discrimination Act (prohibiting discrimination on the ground of genetic heritage) the 2007 Law on drugs (in accordance with the Additional Protocol on Biomedical Research)

Croatia and the Oviedo Convention in some cases national law provisions replicate or reflect certain provisions from the Oviedo Convention -the 2004 Law on Protection of Patients’ Rights (article 16 and article 17 of the Convention) ) -1997 Law on the Protection of Persons with Mental Disorders ( article 7 of the Convention) -the 2009 Law on Medical Fertilization (article 20 of the Law- prohibition of sex selection except in cases of severe genetic disorder; article 31 of the Law explicit prohibition of the creation of embryos for research purposes)

Croatia and the Oviedo Convention the other two Additional Protocols, namely the Additional Protocol on Biomedical Research and the Additional Protocol concerning Genetic Testing for Health Purposes, that are still awaiting the ratification process, are taken into consideration when legislation on similar matter is drafted

Croatia and the Oviedo Convention The Oviedo Convention and its two Additional Protocols ratified by the Republic of Croatia are incorporated in the Croatian legal system and replicated in different implementing laws.

Croatia and the Oviedo Convention at the level of the Council of Europe we could see that the Oviedo Convention and its Additional Protocols are providing us with new standards in this field of human rights and biomedicine the next step should be increased harmonization of national standards with the Convention through its acceptance by all the Member States of the Council of Europe stronger focus on its implementation is needed, and establishment of the reporting and monitoring process could be envisaged by the Steering Committee on Bioethics in the next decade