CYIL vol. 14 (2023)

CYIL 14 (2023) NEW METHODS IN MEDICINE: CZECH PRACTICE IN LIGHT OF THE CONVENTION… complied with the officially authorised plan of the research study, or that they departed from it in justified cases for important reasons explained in the patient’s medical records. 28 3. Convention on Human Rights and Biomedicine and the Additional Protocol concerning Biomedical Research The Convention on Human Rights and Biomedicine of 1997 (Convention) was ratified by the Czech Republic in 2001. 29 Its fundamental value standpoint is clearly proclaimed in the Convention’s crucial interpretation principle 30 expressed in Article 2: “ The interests and welfare of the human being shall prevail over the sole interest of society or science. ” It would be impermissible to sacrifice an individual for the sake of science and, by extension, society as a whole. According to Article 4 of the Convention, “ [a]ny intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards ”. New methods need to be performed on a sufficiently high professional standard. Any medical research on a person can only be carried out if several cumulative criteria defined in Article 16 of the Convention are met. These include the lack of any alternative of comparable effectiveness to research on humans, the proportionality of risks and benefits of the research, or the approval by a competent body (we will later analyse the last condition in more detail). Additional criteria for patients unable to consent are set in Article 17. The results of the research must have the potential to produce real and direct benefit to the health of the individual vulnerable patient, it must be impossible to carry out research of comparable effectiveness on individuals capable of giving consent, and the necessary authorisation of the patient’s legal representative must have been given specifically and in writing. If the patient objects, their involvement in the research project will usually be excluded. We might recall the criteria for the use of new methods under the Czech ASHS which are in accordance with the outlined conditions set by the Convention. In fact, the specific nature of new methods makes their special regulation even stricter since it is not possible to perform the method on a patient for whom it does not bring any health benefit, even if the risk and burden to this patient are minimal and the research aims to help the patient’s demographic group, as an exception allows under the Convention. 31 28 See ibid., p. 179. 29 See ŠUSTEK, P. Two Decades of the Convention on Biomedicine: Has It Been Any Good? In ŠTURMA, P. (ed.). Czech Yearbook of Public & Private International Law. Česká ročenka mezinárodního práva veřejného a soukromého. Vol. 9. Česká společnost pro mezinárodní právo, Praha 2018, pp. 257–269. 30 According to the Explanatory Report to the Convention on Human Rights and Biomedicine, point 21, all articles of the Convention must be interpreted in light of this principle of the primacy of the human being. 31 See Section 17(2) of the Convention on Human Rights and Biomedicine: Exceptionally and under the protective conditions prescribed by law, where the research has not the potential to produce results of direct benefit to the health of the person concerned, such research may be authorised (…) to the following additional conditions: i) the research has the aim of contributing, through significant improvement in the scientific understanding of the individual’s condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition; ii) the research entails only minimal risk and minimal burden for the individual concerned.

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