CYIL vol. 14 (2023)

MARTIN ŠOLC CYIL 14 (2023) The Convention also puts stress on informed consent, either on the general level or specifically for persons unable to consent. The patient must be informed of the purpose and nature of the intervention as well as of its consequences and risks; a list that is in Czech law complemented by other information including alternatives to the proposed treatment or limitations to future life activities. 32 Specifically for research purposes, the Convention also requires that participants are informed of their rights and legal safeguards and that their consent is given expressly, specifically, and is documented. In 2005, the Council of Europe opened for signatures the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (Additional Protocol). Ratified by the Czech Republic in 2018, the Additional Protocol importantly clarifies certain areas of regulation relevant to research including the evaluation of new methods. Among other specifications, the Additional Protocol sets rules for the independent examination of research projects by ethics committees and widens the scope of information that must be provided to a participant. This necessary information includes the arrangements for responding to adverse events, the arrangements to ensure respect for private life and ensure the confidentiality of personal data, or the arrangements for fair compensation in the case of damage. Furthermore, if the capacity of the person to give informed consent is in doubt, arrangements must be put in place to verify whether or not the person has such capacity. Another area of regulation the Additional Protocol sets new rules in is the protection of vulnerable groups of research participants, namely pregnant or breastfeeding women, persons in emergency clinical situations, and persons deprived of liberty. 4. Issues of Compatibility of the Czech Regulation and the Convention on Human Rights and Biomedicine Based on the above-presented overview of the regulation of new medical methods in Czech law and in the Council of Europe’s system of human rights protection, we can identify two areas where there can arguably be doubts regarding the compatibility of the former with the latter. These are: – the lack of a specified compensation scheme or strict liability regime, and – the lack of a robust and enforced official approval system for new medical experiments. 4.1 The Lack of a Specific Compensation Scheme In Czech law, there is no special type of liability for damage that occurs in medical research. Furthermore, strict liability is restricted to contractual liability and special cases of tort liability explicitly defined in the law. 33 These special cases include, for example, damage caused by a defective thing used while fulfilling the tortfeasor’s obligation 34 or damage caused by operating activities 35 (which does not apply to medical practice 36 but may apply, for

32 See Section 33(2) of Act No. 372/2011 Sb., on Health Services and Conditions of Their Provision. 33 See Sections 2895 and 2913 of Act No. 89/2012 Sb., the Civil Code. 34 See Section 2936 of the Civil Code. 35 See Sections 2924 and 2925 of the Civil Code. 36 See the Regional Court in Hradec Králové judgment of 17 September 1997, file no. 25 Co 167/97, or for example the Supreme Court of the Czech Republic judgment of 31 August 2004, file no. 25 Cdo 2542/2003.

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