CYIL vol. 14 (2023)

CYIL 14 (2023) NEW METHODS IN MEDICINE: CZECH PRACTICE IN LIGHT OF THE CONVENTION… the method must be at least potentially beneficial for the health of the particular patient, they must also be informed about this possible individual health benefit. The consent can be withdrawn at any moment during the evaluation. Specific further conditions apply to minors and patients with limited legal capacity. The proxy informed consent must be given by their legal representatives (usually parents or guardians). Furthermore, they can only be enrolled in the project if the evaluation of the new method cannot be performed with comparable effectiveness on patients capable of giving consent for themselves. Even if the patient is not capable of that, their assent must be secured, given that their mental maturity and ability to understand the relevant information allows it. The minor’s disagreement with their participation in the research study can only be disregarded if the application of the new method represents the only possible treatment for their otherwise incurable disease. Once the provider of health services obtains the ministerial approval and starts the evaluation study, they are obliged to issue regular reports on the research progress to the Ministry of Health. The same Ministry can withdraw the approval if the provider no longer meets the requirements set by law or by their individual approval. If there arises reasonable doubt that the new method will not produce the expected result, or that its evaluation could lead to long-term or serious damage to the health of the patient, the provider must immediately interrupt or stop the evaluation study and notify the Ministry of Health of this fact. In case the evaluation study is successful, the provider will submit a final report to the Ministry of Health. Based on this report, the Ministry of Health will assess whether the new method meets the conditions for introduction into clinical practice and whether it will contribute to the improvement of the health condition of patients. If the answer to this question is in the affirmative, the Ministry of Health will officially acknowledge the new method as a standard method. 2.2 Evaluation of New Methods in Czech Practice The above-described regulation, embodied in just eight provisions of the Act on Specific Health Services, provides a basic framework while many particular questions are open for interpretation. However, its most important problem lies in the fact that it is almost entirely ignored in practice. Since the ASHS entered into force in April 2012, only four evaluation studies of new methods were approved by the Ministry of Health, all of them between the years 2012 and 2016. Just one method was successfully acknowledged as a standard method by the Ministry; another method was re-defined as a modification of the said acknowledged method and thus ceased to be considered non-established in the sense of the law. Another two approved studies have not yet been closed. One of them is a relatively large study on uterus transplantation which will probably be officially rebranded as an already established method since it was introduced into clinical practice in Germany several years ago, but the Ministry of Health has not yet issued a decision on the matter. 21 However, it would not be correct to assume that medical progress in the Czech Republic has come to a halt. At the same time, the practice of new methods in the country is not illegal

365

21 See ibid., pp. 72–73.