CYIL vol. 14 (2023)

MARTIN ŠOLC CYIL 14 (2023) of the liability regime remains fully in control of the national law, and both fault-based and strict liability are permissible options. The Czech Republic does not violate the said international law requirement. More complicated might be the situation regarding the second potential problem which consists in the lack of a robust and enforced system for approving studies of new methods. Both the Convention on Human Rights and its Additional Protocol concerning Biomedical Research require that every research project must be “ approved by the competent body after independent examination of its scientific merit ”. The definition of a competent body is, however, left to the discretion of each State Party. We may recall the Explanatory Report to the Additional Protocol again, which explicitly lists ethics committees as an option for the competent approving body. The most problematic is the requirement expressed in the said Explanatory Report that the research complies with national law. Czech law does not make it entirely clear whether and under what condition can the use of a new method be legal outside of the formal framework of evaluation approved by the Ministry of Health. Nevertheless, an interpretation of the Czech regulation that would allow for such uses of new methods (or the possible decision of the lawmaker in the same direction) would comply with the country’s international obligations. The Czech regulation on new methods is in many ways imperfect and perhaps even impractical. Nevertheless, it provides fundamental safeguards against reckless and unsafe research projects, secures the participants’ informed consent as well as their right to compensation in case of harm, and requires certain oversight. This is safely sufficient to meet the requirements set by international law. The vagueness of these requirements reflects the specific and nearly elusive character of new medical methods in comparison with drugs and medical devices. In this regard, it is only logical and preferable. Nevertheless, we believe that it might be commendable that a sufficient level of legal certainty be included in the requirements. The Czech regulation seems to be in need of such an incentive.

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