CYIL vol. 14 (2023)

CYIL 14 (2023) NEW METHODS IN MEDICINE: CZECH PRACTICE IN LIGHT OF THE CONVENTION… of the domestic law, it “ does not set out a specific procedure or sequence for the submission of research projects to the relevant bodies. ” 43 It is without doubt that the Convention on Human Rights and Biomedicine as well as its Additional Protocol allows for the ethics committees to be the arbiter of ethical acceptability of research projects (if this process complies with the national law). Nevertheless, it could still be questioned whether they also suffice for examining the scientific merit of each study, as it is required by both international documents. We believe that the question is affirmative. The composition of the ethics committees needs to be multidisciplinary, which in practice means that professionals from the relevant field of medicine are always represented. These medical experts do not only provide an insight into the actual content of the research projects to other committee members but also assess the projects from the perspective of their scientific justification. At the very least, they might express their concerns regarding the low scientific meaningfulness of a project or its serious riskiness. For this reason, we believe that multidisciplinary ethics committees as required by international law and as practiced in Czech hospitals are capable of assessing both the ethical acceptability and the scientific merit of studies of new medical methods. 44 The biggest question regarding the compatibility of the Czech practice of performing new methods with the Council of Europe’s system of human rights protection paradoxically remains in the uncertainty regarding the legality of using new methods outside of the formal evaluation framework under the domestic law. The important finding is, however, that if we interpret Czech law as allowing for the ethics committees to be the sole subject to approve the relevant studies (or if perhaps the lawmaker ever clarifies this explicitly in the law), such a solution complies with the Convention on Human Rights and Biomedicine. Conclusion From all the branches of medical research, new methods are the least regulated. Czech law provides a formal framework for their evaluation based on the approval issued by the Ministry of Health, but this system is largely ignored in practice where new methods are usually tested only based on the local ethics committee’s approval and then organically accepted in the clinical practice. Studies of new methods are not specifically addressed by international law, but the more general regulation of medical research embodied mainly in the Convention on Human Rights and Biomedicine and its Additional Protocol concerning Biomedical Research apply to them. In most areas, the Czech legal regulation and practice comply with the Convention’s requirements unproblematically. Nevertheless, there are two possible issues of concern. The first of them consists in the lack of a specific compensation scheme. Under current Czech law, a general fault-based liability regime applies to harms caused during the evaluation of new methods. Article 31 of the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research requires that an injured person “ shall be entitled to fair compensation according to the conditions and procedures prescribed by law. ” Nevertheless, according to the Explanatory Report to the Additional Protocol, the choice 43 Ibid., point 28. 44 See ŠOLC, M. Nové metody v medicíně a právo. [New Methods in Medicine and the Law.] Wolters Kluwer, Praha 2022, p. 69.

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