CYIL vol. 14 (2023)

HELENA VAN BEERSEL KREJČÍKOVÁ CYIL 14 (2023) The current knowledge on conflicts of interest in research in general, and medical research in particular, seems to be rather limited in the Czech Republic. Therefore, in this paper I map the current legal framework, policies and procedures adopted by the Czech entities involved in the assessment of clinical trials for the purposes of marketing-authorization of a medicine (i.e., State Institute for Drug Control 20 ) and the main public agencies funding medical research (i.e., the Czech Science Foundation 21 and the Technological Agency of the Czech Republic 22 ). In so doing, I would like to demonstrate how the Czech approach differs from the regulations adopted in the US and the EU regulations, which the Czech Republic is to a certain extent subject to as well. Regulation of conflict of interest in medical research One of the first milestones in conflict-of-interest evolution in medicine is the 1950s’ tobacco industry campaign, undermining and distorting scientific data on the harmful effects of smoking. 23 Since then, conflicts of interest have been studied with regard to medical research and publication practice, developing guidelines, teaching, and conducting professional practice (as a physician or as another healthcare professional). 24 As the US could be seen as a country from which conflicts of interest arose and where they are currently extensively regulated, the US regulation on conflicts of interest in medical research will be described in more detail in the following subchapter. Further, the regulation and applicable policies on the EU level and in the Czech Republic will be introduced to establish how conflicts of interest in medical research are being paid attention to and to evaluate whether there is an adequate mechanism in the Czech Republic put in place to protect research integrity and to avoid spin and bias in medical research. USA In the US, conflicts of interest in medicine have been systematically discussed and addressed for decades, as physician-industry relationships gradually became a day-to-day reality. According to the results of a national study conducted on 3 167 physicians (out of which 1 662 completed the questionnaire) in late 2003 and early 2004, 94 % of the respondents reported at least one of the following benefits received from the industry within the previous year: drug samples, gifts, food or beverage at workplace, tickets to cultural or sporting events, reimbursement for continuing medical education (free or subsidized), reimbursement for meeting expenses (e.g., travel, food, lodging), payments: for consulting, for the scientific evaluation, supervision and safety monitoring of medicines in the EU. In: EMA. European Medicines Agency. Accessed June 23, 2023. https://www.ema.europa.eu/en. 20 Státní úřad pro kontrolu léčiv. [State Institute for Drug Control]. Accessed August 15, 2023. https://www.sukl.cz. 21 Grantová agentura České republiky. [Czech Science Foundation]. Accessed August 15, 2023. https://gacr.cz/en/. 22 Technologická agentura České republiky. [Technology Agency of the Czech Republic]. Accessed August 15, 2023. https://www.tacr.cz/en/. 23 BRANDT, A. M. Inventing Conflicts of Interest: a History of Tobacco Industry Tactics. Am J Public Health . 2012;102(1):63-71. doi:10.2105/AJPH.2011.300292. 24 Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice. Conflict of Interest in Medical Research, Education, and Practice . (Lo B, Field MJ, eds.). National Academies Press (US); 2009.

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