CYIL vol. 14 (2023)

MARTIN ŠOLC CYIL 14 (2023) or hidden. In fact, new methods are mostly carried out in studies approved by local ethics committees without applying for the ministerial approval. 22 The performance of new methods outside of the legal framework under the ASHS is nevertheless legally uncertain. The law states that the evaluation of new procedures can only be carried out on living persons under the conditions set by the ASHS. 23 It is an administrative offence to “carry out the evaluation of a not-yet established method without the ministerial approval”, punishable with a fine of up to 500,000 CZK (circa 20,000 EUR). 24 It might be argued that this fact clearly renders carrying out research studies without the formal framework set by the law as illegal. However, there are at least two problems related to this conclusion. The first issue consists in the definition of the “evaluation of a not-yet established method”. The law explicitly prohibits the evaluation of new methods outside of the formal framework, not their performance as such. It could be argued that performance is a broader term than evaluation and that only the use of new methods in systematically organised research studies requires the ministerial approval. In this interpretation, the performance of new methods in individual cases when they are needed for the patient does not necessarily require the approval of the Ministry of Health, even if it leads to the ever more common use of such methods and ultimately to their becoming a normal part of the clinical practice. 25 The second, and perhaps more important, problem is that even if we concluded that the performance of new methods without the ministerial approval is prohibited in all cases, it does not say anything about civil or criminal liability. On the contrary, it only means that such a practice is administratively prohibited and that it gives rise to an administrative offence punishable with the above-mentioned fine. It is not possible to automatically assume that the breach of this administrative duty also has a bearing on other types of liability. 26 In fact, the breach of this administrative duty does not necessarily bear any relevance to the possible harm that occurred to the patient. What matters for the patient is whether the method was carried out in accordance with the standard of care, not whether the provider had the relevant administrative authorisation. Furthermore, a causal link between the lack of ministerial approval and the harm would be at best very dubious. 27 It needs to be noted, though, that ministerial approval brings to the provider an advantage for a hypothetical medical negligence lawsuit. This is because a successful malpractice claim always requires evidence for the breach of duty, which often consists in the breach of the standard of care. In a new method, it is very difficult to define what the professional standard is. Therefore, the provider’s position can be significantly uncertain since they cannot be sure how to proceed while carrying out the new method in order to keep in line with the standard that will be ultimately defined ex-post by the court. On the other hand, if they have already obtained the Ministry of Health’s approval, the provider can show evidence that they

22 See ibid., p. 74. 23 See Section 33(1) of Act on Specific Health Services. 24 See Section 90(3)a) in connection with Section 90(7)b) of Act on Specific Health Services. 25 See ŠOLC, M. Nové metody v medicíně a právo. [New Methods in Medicine and the Law.] Wolters Kluwer, Praha 2022, pp. 69–70. 26 See ibid., p. 225. 27 See ibid., pp. 70–71.

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