CYIL vol. 14 (2023)

CYIL 14 (2023) NEW METHODS IN MEDICINE: CZECH PRACTICE IN LIGHT OF THE CONVENTION… example, to hospital-acquired infections 37 ). None of these cases directly apply to medical research. There might be a discussion on whether the amended Section 58 of Act No. 378/2007 Sb., on Pharmaceuticals, contains such a special case of strict liability for clinical trials of medicinal products. Furthermore, a part of the legal doctrine argues that strict liability should have applied to clinical trials even before the mentioned amendment of the Act on Pharmaceuticals came into force. Petr Šustek and Tomáš Hočapek argued back in 2016 that certain principles of the above-mentioned special cases of strict liability (i.e., liability for damage caused by a thing and liability for damage caused by operating activities) should be applied analogously in this context. Since the development and testing of new drugs is in the interest of society, it is just to compensate a person who suffered harm because they had agreed to participate in such testing. 38 Nevertheless, these considerations only directly apply to new drugs. We believe that their extension to new methods, even if possible, would not be appropriate. As we have shown above, new methods are rather different than medicines in nature, being much more individualised and their performance being much closer to normal clinical practice than highly formalised testing of medicinal products. As a result, research study participants usually not only have direct benefit from the new method, but it often represents their best (or only) chance for the improvement of their health condition. 39 Even though the question of whether strict liability should or should not apply to new methods might be open, the currently applicable law is based on fault liability. The question might be asked whether it complies with the requirements set by the Council of Europe human rights documents. The Additional Protocol concerning Biomedical Research states in Article 31 that “ [t]he person who has suffered damage as a result of participation in research shall be entitled to fair compensation according to the conditions and procedures prescribed by law. ” At first sight, it might be argued that this provision creates an obligation for the State Parties to secure the position of the plaintiff in medical negligence cases related to research by establishing strict liability or a specific compensation scheme for this type of situation. However, the provision is to be applied within the system and boundaries of the national law of each country. As the Explanatory Report to the Additional Protocol explicitly clarifies, persons who have suffered damage resulting from their participation in research shall be fairly compensated according to the conditions and procedures prescribed by law. (…) Compensation conditions and procedures are prescribed by national law. In many cases, this establishes a system of individual liability based either on fault or on the 37 See ŠUSTEK, P., HOLČAPEK, T. Občanskoprávní odpovědnost zdravotnických pracovníků a poskytovatelů zdravotních služeb. Odpovědnost obecná a zvláštní. [Civil Liability of Health Professionals and Providers of Health Services. General and Special Liability.] In ŠUSTEK, P., HOLČAPEK, T. (eds.). Zdravotnické právo. [Health Law.] Wolters Kluwer, Praha 2016, pp. 306–307. 38 See ibid., pp. 311–313. These ideas are also reflected and followed up on in ŠOLC, M. Klinické hodnocení léčiv jako případ objektivní odpovědnosti? [Clinical Trials of Medicinal Products as a Case of No-Fault Liability?] Časopis zdravotnického práva a bioetiky. [Journal of Medical Law and Bioethics.] (2020, Vol. 10, No. 2), pp. 71–83. 39 See ŠOLC, M. Nové metody v medicíně a právo. [New Methods in Medicine and the Law.] Wolters Kluwer, Praha 2022, p. 88.

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