CYIL vol. 14 (2023)

CYIL 14 (2023) NEW METHODS IN MEDICINE: CZECH PRACTICE IN LIGHT OF THE CONVENTION… No. 375/2022 Sb., on Medical Devices and In Vitro Diagnostic Medical Devices. Evaluation of new methods is regulated in the Title III of Act No. 373/2011 Sb., on Specific Health Services (Act on Specific Health Services or ASHS). This variety of regulations is arguably justified by the differences in the very nature of the outlined research branches. Compared to medicines and medical devices, new methods are by far the least regulated branch of medical research. The vagueness starts with the lack of a consensually accepted definition, even though a method is usually understood as know-how regarding a certain set of partial actions. 17 While medicines and medical devices are largely regulated on the European level, there is no EU regulation directly aimed at new methods. Internationally, there is no unified methodology or structure required for their testing. Research studies on new methods are as a rule carried out within the national regulatory framework, without much direct involvement of international law. 18 While drugs and medical devices need to be registered before entering clinical practice in a very rigorous process, the rules regarding new methods are varied among different countries, often being very vague. These differences in part reflect a very specific nature of new methods. While a drug or a medical device is always the same product with the same characteristics (even though the organism’s response to it might differ in particular cases), a method is always to a certain degree unique as also the body of the patient and their current situation is unique. At the same time, methods are usually more or less invasive, which means they are connected with a non-negligible level of risk. Unlike drugs and medical devices, the efficacy and safety of new methods cannot be tested separately. While the first stage of clinical trials usually consists in safety testing of a drug given to healthy volunteers, a similar procedure cannot be performed with new methods. On the contrary, new methods can only be carried out on patients suffering from the targeted health condition, and their safety and efficacy are tested inseparably. As a result, new methods are often tested on very low numbers of patients, often individuals or, at the maximum, a few dozen of them. A small set of test subjects that would not suffice to produce statistically significant results in a clinical drug trial can be understood as very large for new methods testing. The interpretation of such testing is much closer to a series of proof-of-concept case studies than to nuanced statistical evidence known from clinical trials. For that reason, studies on new methods are usually less expansive than clinical trials of drugs. Unlike medicinal products, new methods still offer an individual expert or a small team the opportunity to write medical history, 19 which might inspire innovation but also may provoke recklessness. Nevertheless, the inherent riskiness of new methods, as well as their crucial importance for the advancement of medicine, calls for a rational legal framework. It will be discussed later in this paper whether the Czech regulation can be understood as corresponding to this requirement.

17 See ŠUSTEK, P. Ověřování nezavedené metody. [Evaluation of a New Method.] In ŠUSTEK, P., HOLČAPEK, T. (eds.). Zdravotnické právo. [Health Law.] Wolters Kluwer, Praha 2016, p. 721. 18 See KŘEPELKA, F. Právo zdravotnického výzkumu. [The Law of Medical Research.] Masarykova univerzita, Brno 2004, p. 37. 19 See ibid., p. 46.

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