Vulnerable people and clinical trials. Reflexions in European law

Abstract

Who are vulnerable people? Why are they vulnerable in clinical trials? How are they protected in European law? Health research poses the old but constantly renewed dilemma of how to balance individual interests and integrity with the protection and promotion of public health. The case of vulnerable people will serve both as the subject of interest and as a heuristic tool. Why are older adults not a category of vulnerable participants? Why assimilate pregnant women to people unable to defend their interests? Why should patients suffering from orphan diseases be classified as a vulnerable category in clinical trials? How should participants from developing countries be classified? Vulnerability is dominantly approached through vulnerable categories as opposed to a proper definition. However, such an approach not only turns out to be stigmatizing, but also implies a one-size-fits-all protection rarely suitable to all. This work suggests to define vulnerability starting by distinguishing between the types of risk, to then only highlight the factors of vulnerability and, when appropriate, vulnerable categories. This thesis explores how the laws of the Council of Europe and of the European Union protect vulnerable people in clinical trials, with the underlying aim to analyse if and how this protection contributes to the construction of a concept of vulnerability. First, European law related to clinical trials seems to be mainly focused on individual vulnerability, more precisely on decisional vulnerability i.e. vulnerability to risks of violation of autonomy in the decision-making process of a (potential) trial participant. Vulnerable groups benefit from a solid protection when they cannot give valid consent, be it de jure like for instance minors and incapacitated adults, or de facto for instance persons who are unconscious or deprived of liberty. Nonetheless whenever the situation of vulnerability is more subtle and the potential participant only unable to defend his/her interests (e.g. suicidal or psychiatric patients, socially or economically disadvantaged groups, people in a situation of deference or dependency), European law is pretty much silent. This is all the more surprising because asymmetrical compared to the increasing implication of European law in specific safeguards for designated vulnerable groups. Second, European law does not openly describe a collective concept of health vulnerability dealing with negative consequences of underrepresentation of vulnerable groups in clinical trials on the safety and efficacy of medicinal products. Nonetheless, it does offer concrete although isolated solutions for paediatric and orphan medicines. It also provides for emerging processes which, although not comparable to the former palliative regimes, are also promoting research on specific health needs of older adults and of patients from developing countries. However, these provisions are scattered and, most importantly developed over political decisions lacking coherency as there are a lot more vulnerable groups who have similar needs, for instance pregnant women. This protection should rather stem from a generic approach grounded in European fundamental rights and public health ethics underlining the need for equitable access to health care and thus equitable representation of vulnerable groups in clinical trials.