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Dr Wiktor Krzymowski
ORCID: 0000-0002-0145-9767

Advocate, doctor of social sciences in law, LL.M. in international commercial law. He graduated with distinction in law from the Faculty of Law and Administration of the University of Warsaw and completed legal training at the District Bar Council in Warsaw. He is a graduate of Postgraduate Studies in Medical Law, Bioethics and Sociology of Medicine at the University of Warsaw, where he also defended his doctoral thesis in the field pharmaceutical and reimbursement law and philosophy of law. He has been dealing with issues related to pharmaceutical law, including clinical trial law, since 2009.

 
On the admissibility of transferring remuneration to participants in clinical trials of medicinal products under EU law, s. 39-46
DOI: 10.33226/0137-5490.2024.7.6
JEL: K23
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On the admissibility of transferring remuneration to participants in clinical trials of medicinal products under EU law

This article focuses on a dogmatic-legal analysis aimed at solving the research problem of whether it is permissible to provide compensation to participants for their involvement in a clinical trial in the EU. In 2023, Polish law abolished the general ban on transferring benefits to clinical trial participants. Currently, this issue is regulated exclusively by EU law. It doesn't contain a general prohibition on paying remuneration to participants for participating in a clinical trial, unless they belong to vulnerable populations and unless it constitutes undue financial influence when granting an informed consent. EU soft law confirms the admissibility of transferring remuneration, indicating that it may be in cash or in kind. Compensation may be conditional, including completion of a specific stage of a clinical trial. One cannot demand a refund of the remuneration due from a participant because of the withdrawal of consent.

Keywords: clinical trial; financial inducement; undue financial influence; clinical trial subject; payments