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PETR ŠUSTEK CYIL 9 ȍ2018Ȏ for the lack of a special and modern regulation of informed consent until 2018 when Law 219/2017 came into force. 60 Even Germany has not signed the Convention for similar reasons: it considers the Convention too liberal, mainly regarding the most controversial issues including embryonic research or non-therapeutic research on persons unable to consent. 61 This stance might be popular among German voters, since facing the ghosts of its past, the country has been traditionally very cautious in bioethics issues. However, even most German legal experts and ethicists consider the far-reaching criticism of the Convention inaccurate. 62 Furthermore, both Italian and German reservations arguably make little sense because of the Convention’s nature as a minimum standards document: even after the ratification, both countries could keep their more restrictive regulation. The approach of both countries should be understood as a manifestation of values, which are considered critically important by these nations (or their political representations). We can see that there are generally two main reasons for not ratifying the Convention. The first one is when the national legislature considers its content too restrictive to the country’s freedom of action or to force an adoption of a course of action the country does not wish to take. In the relatively liberal Czech society, this reason could hardly be relevant. The second reason is unpreparedness of national legislation. We have to appreciate the courage (though arguably alleviated by significant ignorance of the Convention’s potential impact) with which the Czech Republic ratified the Convention in spite of its unprepared legislation. Conclusion The Convention has profoundly changed the legal and social environment of health care in the Czech Republic. The transformation of the health care paradigm from paternalism to partnership was led by legislation, case law, and writings of legal scholars. Czech society, including patients themselves, was rather surprised by the changes. The classic phases of the legislative process can be described as: 1) detection of the need for a legislative change, 2) intention to regulate the matter, and 3) carrying out of the regulatory intention 63 . In the case of Czech medical law, the change seems to have proceeded in the opposite direction. A binding and directly applicable international law document – the Convention – was ratified, and subsequently forced the legislature to amend the existing regulations and enact new laws. The society then had to learn to live in the new environment. The transformation that took several decades in many countries had to be carried out over the course of several years in the Czech Republic. It may be concluded that the Convention 60 See FOGLIA, Massimo. Consenso e cura. La solidarietà nel rapporto terapeutico. [The Consent and the Cure. Solidarity in the Therapeutic Relationship.] G. Giappichelli Editore, Torino 2018. For a very brief introduction to an older Italian regulation of informed consent, see SCARSO, Alessandro P., FOGLIA, Massimo. Medical Liability in Italy. In KOCH, Bernhard A. (eds.). Medical Liability in Europe. A Comparison of Selected Jurisdictions. De Gruyter, Berlin, Boston 2011, pp. 345-347. 61 ANDORNO, Roberto. The Oviedo Convention: A European Legal Framework at the Intersection of Human Rights and Health Law. Journal of International Biotechnology Law. (2005, Vol. 2, No. 4), p. 134. 62 Deutsches Referenzzentrum für Ethik in den Biowissenschaften. Convention on Human Rights and Biomedicine. accessed 6 June 2018. 63 KNAPP, Viktor. Teorie práva. [Theory of Law.] C. H. Beck, Praha 1995, pp. 110-111.

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