CYIL vol. 14 (2023)

CYIL 14 (2023)

CONFLICT OF INTEREST IN MEDICAL RESEARCH

The European Union Within the EU, the perceived counterpart of the FDA is the European Medicines Agency (further referred to as EMA). However, the powers of FDA and EMA differ significantly. Firstly, EMA carries out a scientific assessment of a marketing-authorization application and gives a recommendation on whether a medicinal product for human use shall, or shall not be authorized. However, it is the European Commission which takes the legally binding decision to authorize the product. 62 Furthermore, EMA does not possess the authority to evaluate, authorize and supervise clinical trials, as those are the responsibilities of EU Member States (European Economic Area countries) harmonized by Regulation (EU) No. 536/2014, on clinical trials on medicinal products for human use (Clinical Trials Regulation). 63 That is perhaps also the explanation for why EMA has not adopted any conflict-of-interest policies aimed at marketing-authorization applicants (researchers, investigators). 64 Nevertheless, the Clinical Trials Regulation does not offer any detailed rules on conflicts of interest, either. The issue of conflict of interest and potential bias basically exhausts itself in what is stated to be a general principle of the Regulation, acknowledging the predominance of the interests of the subjects (of the clinical study, i.e., the patients) over all other interests, 65 while simultaneously recognizing the legitimate economic interests of sponsors. 66 In addition, there is a brief requirement to submit information (via application dossier for the initial application) on the suitability of the investigator regarding any conditions, such as economic interests and institutional affiliations, that might influence the impartiality of the investigators. Moreover, the information on financial transactions and compensation paid to subjects and investigator/site for participating in the clinical trial shall be submitted, together with the description of any other agreement between the sponsor and the site. The summary of the results of the clinical trial shall contain information about sources of potential bias. 67 The lack of the Clinical Trials Regulation’s provisions on how to identify and properly manage conflicts of interest could be explained by the anticipated role of a Member State and national medicines authorities (e.g., the Czech State Institute for Drug Control). Whether it is indeed the case will be discussed further in this paper. 62 Cf. to Art. 10 and ff. of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency . 63 Regulation (EU) 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 (with transition period of applicability of the Directive until 30. 1. 2025). Accessed August 15, 2023. https://eur-lex.europa.eu/legal-content/EN/TXT/ PDF/?uri=CELEX:32014R0536. 64 Cf. EMA’s extensive policies on handling competing interests when it comes to scientific committee members and experts, management board members, staff members and staff members leaving EMA. Available online https:// www.ema.europa.eu/en/about-us/how-we-work/handling-competing-interests. Accessed August 15, 2023. 67 e.g., Annex I. and IV. of the Regulation on Clinical Trials on Medicinal Products for Human Use (Content of the summary of the results of the clinical trials). I assume, however, that the aim of this provision is to target other types of research bias, such as selection bias, performance bias, or reporting bias, rather than bias caused by conflicts of interest. 65 Cf. Art. 3 of the Clinical Trials Regulation. 66 Point 67 of the Clinical Trials Regulation.

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