CYIL vol. 14 (2023)

MARTIN ŠOLC

CYIL 14 (2023)

2. The Czech Regulation of New Methods in Medicine The current Czech regulation on new medical methods came into force in April 2012 with Act No. 373/2011 Sb., on Specific Health Services. The Title III of this statute is dedicated to what the lawmaker calls “the evaluation of new procedures using a method that has not yet been introduced into clinical practice for the use on a living human being”. For the sake of brevity and clarity, we will abbreviate this term as the evaluation of new methods. 2.1 Formal Evaluation of New Methods According to the Law The formal process starts with the application to the Ministry of Health of the Czech Republic. The application needs to contain the research project in which the crucial parameters of the study are defined, including its detailed plan, an overview of the relevant current knowledge, the involved health facility and health professionals, or the demographic groups of patients. The Ministry of Health will issue the approval if it deems the project useful and if the relevant health services provider is professionally capable for the task. The former requirement can be divided into several criteria, including the fact: a) that the new method can be expected to bring favourable results to the benefit of the patient on whom it is to be tested on, b) that it can be reasonably assumed that the evaluation will be successful and the new method will become a standard preventive, diagnostic, or treatment procedure, c) that the evaluation of this method cannot be achieved with comparable effectiveness in another way, and d) that there is no justified particular risk of long-term or serious damage to the health of the patient. Importantly, methods are not considered new (or, in the terminology of the law, not yet introduced into clinical practice) if they have already been established in clinical practice in any Member State of the European Union, European Economic Area, or in Switzerland. A method is also not considered new if it is only a modification of an already-established method and at the same time, its use does not have adverse effects on the patient’s health. Sometimes, a method can clearly be identified as either new or modified. For example, a slight improvement in a partial technical aspect of the procedure such as in the suturing technique will be a modification, while the use of the method on a new organ with its anatomical and physiological specifics will represent a new method. However, the line between the two categories is often blurred. In case of doubt, the decision will be made by the Ministry of Health, but there have not yet been any closer criteria clarified for its decision-making. We believe that the crucial criterion is whether the risk the method poses for the patient, compared to the risk of the older form of the method, is both real (i.e., not only hypothetical) and sufficiently increased from the perspective of its seriousness and probability. 20 Before the evaluation is commenced, the provider of health services is obliged to establish an ethics committee that will assess the study from an ethical standpoint and exercise supervision over it. The provider must also have liability insurance for personal injury that could occur to patients. New methods can only be evaluated on patients who have given informed consent. The scope of information is similar to the general information duty in clinical practice, while the patient must also be informed about the purpose for which the method is evaluated. Since 20 See ŠOLC, M. Nové metody v medicíně a právo. [New Methods in Medicine and the Law.] Wolters Kluwer, Praha 2022, pp. 65–67.

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