CYIL vol. 11 (2020)

MARTIN ŠOLC CYIL 11 (2020) participant’s best interests: the principle of direct benefit, the principle of subsidiarity, and the principle of autonomy. Before we outline them closer and analyse their reflection in Czech law, it should be mentioned that Czech Act No. 378/2007 Coll., on Pharmaceuticals will soon undergo a profound change. Its amendment will become effective six months after the European Commission publishes a notice in the Official Journal of the European Union that the new EU clinical trials portal and database have achieved full functionality 25 . At the same time, there will start the applicability of Regulation No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (hereinafter “Regulation on Clinical Trials”). The national law will then complement Regulation on Clinical Trials, further strengthening the already significant unification of clinical trials regulation in the EU. The start of the EU portal and database has been repeatedly postponed. As of the autumn 2020, the independent audit of this IT system is planned to start in December 2020 26 . For this reason, Act No. 378/2007 Coll., as valid in autumn 2020, will be hereinafter referred to simply as “Act on Pharmaceuticals”, while the new text of the same act will be referred to as “Act on Pharmaceuticals as amended by Act No. 66/2017 Coll.”. 2.1 The principle of direct benefit According to Article 17 (1) ii of the Convention on Human Rights and Biomedicine, research on a person without the capacity to consent may be undertaken if the results of the research have the potential to produce a real and direct benefit to her or his health. The aim of such research is very close to the therapeutic use of new medicinal products, i.e. the improvement or stabilisation of health. This condition also implies the proportionality between benefits and risks (which is nevertheless required by the general protection of persons undergoing research in Article 16 ii). As the Explanatory Report to the Convention on Human Rights and Biomedicine explains, “the benefit must be real and follow from the potential results of the research, and the risk must not be disproportionate to the potential benefit”. 27 From the ethical perspective, this kind of research could arguably be considered a treatment of the patient, albeit with an increased risk (which, however, needs to be lower than potential benefits). Exceptionally, the research can be carried out even without the potential for direct benefit to the person concerned 28 . Nevertheless, there are several special conditions set by Article 17 (2) for this situation. First of all, other conditions for the research must be met: we will present them below as the principle of subsidiarity and the principle of autonomy. Furthermore, the research must be carried out under the protective conditions prescribed we extract them from the particular norms of international, European, and Czech law, but they could also have been regulated differently in details. For a distinction between rules and principles, see BEAUCHAMP, Tom L., CHILDRESS, James F. Principles of Biomedical Ethics. 7 th ed. Oxford University Press, Oxford 2013, p. 14. 25 Article VIII a) of Act No. 66/2017 Coll., Amending Act No. 378/2007 Coll., on Pharmaceuticals, in connection with Article 82 (2) and (3) of Regulation No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. 26 See Clinical trials – Regulation EU No 536/2014. European Commission . accessed 9 June 2020. 27 Explanatory Report to the Convention on Human Rights and Biomedicine, to Article 17, point 103. 28 It is an exception to the principle of protection embodied in Article 6 (1) according to which the intervention can only be carried out on a person incapable of granting consent if it is for the direct benefit of that person. See Explanatory Report to the Convention on Human Rights and Biomedicine, to Article 6, point 44.

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