CYIL vol. 14 (2023)

MARTIN ŠOLC CYIL 14 (2023) In the European context, the legal endeavour to regulate health care led to the adoption of the Convention on Human Rights and Biomedicine 10 in 1997 which represents the world’s most complex 11 international treaty devoted to the medical field and directly applies to both established clinical practice and research. On the scientific front, the well-structured and detailed systems of medicinal products (drugs) and medical devices development and registration have been established over time, being strictly controlled and enforced by competent national and international authorities. However, new methods are much less regulated than drugs and medical devices. In the Czech Republic, their regulation is furthermore often ignored in practice. This paper will strive to answer the question of whether the Czech regulation and practice of new methods in medicine fulfils the requirements of the Convention on Human Rights and Biomedicine. 1. New Methods in Medicine as a Branch of Scientific Research Medical research is often divided into three branches by both the scholars and regulators. These cover the research on medicinal products (drugs), medical devices, and new methods. 12 Of the three, medicinal products are the most well-defined, even though there are several complementary definitions (as a result, some drugs fit into the scope of medicinal products because of their real and proven function in the human organism while some others are considered medicines simply because they are marketed as ones). 13 Before a medicinal product is registered, it must have been proven effective and safe in humans in clinical trials with a clearly defined structure and many detailed rules that must be followed. To a lesser extent, the same applies to new medical devices (which represent a very broad category of things other than drugs used in health care). 14 While some countries have a unified regulation of all three research branches, other jurisdictions regulate them separately. This is also the case in the European Union and the Czech Republic. Medicinal products clinical trials and registration are regulated by the EU Regulation No 536/2014 on clinical trials on medicinal products for human use 15 and the national Act No. 378/2007 Sb., on Medicinal Products. In a similar manner, medical devices development is regulated by the EU Regulations No 2017/745 on medical devices and No 2017/746 on in vitro diagnostic medical devices 16 as well as by the Czech Act 10 The Council of Europe’s Convention on the Protection of Human Rights and the Dignity of Human Being with regard to the Application of Biology and Medicine, also known as the Oviedo Convention. 11 See ANDORNO, R. 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. doi: https:// doi.org/10.1515/jibl.2005.2.4.133. 12 See ŠUSTEK, P. Medicínský výzkum. [Medical Research.] In ŠUSTEK, P., HOLČAPEK, T. (eds.). Zdravotnické právo. [Health Law.] Wolters Kluwer, Praha 2016, p. 688. 13 See Article 1(2) of Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use. 14 See the two relevant EU regulations: 1) Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, and 2) Regulation (EU) 2017/746 of the European Parliament and the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. 15 Regulation (EU) No 536/2014 of the European Parliament and the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. 16 See the footnote no. 14.

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