CYIL vol. 9 (2018)

CYIL 9 ȍ2018Ȏ TWO DECADES OF THE CONVENTION ON BIOMEDICINE: HAS IT BEEN ANY GOOD? 3. Transformation of Czech health care paradigm The transformation of the Czech medical environment did not happen overnight. Rather than a fast revolution, it was an evolution; but for evolution, it was still a rapid one. All legal regulations enacted after 2001 were based on a human rights catalogue in the Convention. Thus, the Convention has become the cornerstone of Czech medical law. The first law enacted to fulfil some of the requirements of the Convention was Act No. 285/2002 Coll., the Transplantation Act (hereinafter “Transplantation Act”), which came into force in September 2002. The Explanatory Report to the Transplantation Act explicitly states that the law was drafted in order to respect the Convention and the draft of its Additional Protocol concerning Transplantation of Organs and Tissue of Human Origin. 29,30 The Transplantation Act was influenced by many provisions of the Convention, mainly by Articles 19(1), 20, 5, 19(2), 22 and 21. 31 We should also mention the Ministry of Health Decree No. 385/2006 Coll., on Medical Records, which regulates several aspects of informed consent in written form. A very specific matter is regulated by Act No. 227/2006 Coll., on Research on Human Embryonic Stem Cells and Related Activities (hereinafter “Act on Research on Human Embryonic Stem Cells”). Before the adoption of this law, there was no special regulation of embryonic stem cell research in Czech law, even though this research had already been carried out in the country. 32 This situation was contrary to Article 18(1) of the Convention which requires the parties which allow research on embryos in vitro to ensure adequate protection of the embryo. According to the Explanatory Report to the Act on Research on Human Embryonic Stem Cells, the necessity to adequately fulfil the requirements of international law, mainly the Convention, was the primary reason for the adoption of the said Act. 33 The Convention also forced the legislature to adopt several amendments to the Act on the Care for the Health of the People which was, in some of its provisions, incompatible with the Convention. 34 Among the many amendments that took place after 2001, we should highlight the profound changes in the regulation of informed consent (Section 23 of the Act). The version in force until 2007 was merely setting a physician’s obligation to inform a patient or their family on the nature of the illness and necessary medical interventions appropriately so they can become active co-operators in the health care provision. The wording was clearly enabling the physician to decide which information is “appropriate” and which is not. It was even unclear what kind of “appropriateness” was meant by the law, i.e. whether it had 29 The Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin came into force in 2006. As of June 2018, the Czech Republic had not signed it. 30 The Explanatory Report to the Transplantation Act, General Part. 31 See the Explanatory Report to the Transplantation Act, Special Part, the explanations to the particular provisions cited in the text. 32 See ŠOLC, Martin. Právo, etika a kmenové buňky. [Law, Ethics, and Stem Cells.] Wolters Kluwer, Praha 2018, pp. 249-250. 33 The Explanatory Report to the Act on Research on Human Embryonic Stem Cells, General Part, c). 34 See ŠUSTEK, Petr. Zdravotnické právo. [Health Law.] In ŠUSTEK, Petr, HOLČAPEK, Tomáš (eds.). Zdravot- nické právo. [Health Law.] Wolters Kluwer, Praha 2016, p. 35.

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