CYIL vol. 11 (2020)

MARTIN ŠOLC CYIL 11 (2020) really been the case. Limited comprehension and decision-making capacity of minors have been generally considered a justification for the exclusion of minors from the participation in medical research 8 . Also Czech Act No. 378/2007 Coll., on Pharmaceuticals in Section 52 (2) (in the version effective in autumn 2020 9 ) generally excludes several categories of vulnerable persons from clinical trials. One of these categories entails persons younger than eighteen years. The investigator is obliged to make sure that the excluded persons are not involved in the trial. However, the exclusion of minors has had an apparent consequence: their health problems and specific reactions of their bodies have been understudied and underfunded 10 (a similar problem has applied to women, 11 especially those who are pregnant 12 ). Overly protectionist policies can seriously hinder the advancement of paediatric medicine and even endanger minor patients. If new medicinal products are not registered for the use in children, clinicians are forced to use pharmaceuticals registered for adult patients in the so-called off-label regime. It means that the medicinal product is used outside of indications, patient groups, or other characteristics that are set in the summary of product characteristics (SPC). The off-label use of medicinal products is a normal part of clinical practice and perfectly legal, given that it has a sufficient scientific justification. 13 However, as L. F. Ross aptly notes, in such a situation every child’s treatment would remain an experiment since there would be no solid data on safety and efficacy of the medicinal product’s use in children and no guidelines for dosing 14 . That is a rather risky and unfortunate outcome. Without paediatric research, children’s access to quality and safe health care would be limited. The European Court of Human Rights (hereinafter “ECtHR”) came to the conclusion that the right to life guaranteed by Article 2 of the European Convention on Human Rights imposes on the State Parties a positive obligation “to take appropriate steps to safeguard the lives 8 See ROSS, Lainie Friedman. Children in Medical Research: Access versus Protection. Oxford University Press, New York 2006, pp. 1-2. 9 See Chapter 2. 10 See ROSS, Lainie Friedman. Children in Medical Research: Access versus Protection. Oxford University Press, New York 2006, p. 1. 11 See ibid., p. 1, or COONEY, Elizabeth. Females are still routinely left out of biomedical research – and ignored in analyses of data. STAT. (9 June 2020.) accessed 9 June 2020. 12 For example, this has been true in many responses to outbreaks of infectious diseases: “Historically, the interests of pregnant women have not adequately featured in global responses to outbreaks and epidemics. Funders have not asked if the vaccine candidates they are investing in are suitable for pregnant women, and pregnant women have not been included in vaccine trials. The absence of data about the effects of vaccines during pregnancy has in turn resulted in delays or outright denials of access to lifesaving vaccines, as evident in recent responses to Ebola outbreaks.” KRUBINER, Carleigh, FADEN, Ruth R., KARRON, Ruth A. In the race for coronavirus vaccine, don’t leave pregnant women behind. STAT . (25 February 2020.) accessed 28 May 2020. 13 See for example Study on off-label use of medicinal products in the European Union, pp. 7, 9, 39-42. European Commission [online]. (February 2017.) accessed 11 June 2020, or VYMAZAL, Josef, ŠUSTEK, Petr. Vyjádření k současné situaci s kontrastními látkami pro magnetickou rezonanci na bázi chelátů gadolinia [Statement to the current situation with contrast agents for magnetic resonance imaging on the basis of gadolinium chelates]. Česká radiologie. (2017, Vol. 71, No. 4), p. 263. 14 See ROSS, Lainie Friedman. Children in Medical Research: Access versus Protection. Oxford University Press, New York 2006, p. 2.

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