Civil liability and Regulation in The European Market for Unauthorized Uses of Medicines

The thesis proposes a mixed institutional response to the uncertainties surrounding, in the EU, unauthorized uses of medicines, i.e., off-label and compassionate uses. It combines a reinterpretation of civil liability rules in light of the precautionary principle, complemented by a proportional liability model, with a no-fault plan, funded by general taxation and the industry. Both are integrated into a mandatory, non-binding ADR scheme. The thesis develops in three parts. First, the thesis explores EU pharmaceutical regulation, under which off-label uses are legal but represent a regulatory grey area between medical practice and research, where the levels of protection of patients’ health and legal certainty for health actors are low. Secondly, the thesis considers the potential contribution of civil liability rules, i.e., courts, to the regulation of off-label uses in the EU, France, and Italy. It highlights that, through an incremental process of trial and error, EU and national courts are adapting civil liability rules and categories (e.g., fault, product defectiveness, and causation) to tackle uncertain pharmaceutical and vaccinal risks, using the language and the methodology of the precautionary principle. When fully and correctly developed, this approach can promote victims' compensation, incentivize correct practices on the part of health actors (i.e., physicians, manufacturers, and regulators), and educate these latter. Thirdly, the role of a no-fault plan is appraised vis-à-vis those unknown risks that cannot and should not fall under the scope of civil liability. The thesis also considers how the French and the Italian legal systems are using and could use ADR systems to improve access to justice. A well-designed ADR mechanism would let civil liability realize its full potential and avoid distortionary distributive effects. This complex institutional arrangement can thus foster a fair and efficient allocation of uncertain and unknown pharmaceutical risks among the involved stakeholders. The same analysis is conducted about compassionate use programs. Conclusions sum up the outcome of the research and argue for its relevance in other regulatory grey areas. They also contend that such a proposal could contribute to reconciling science and democracy, i.e., experts’ accountability from below and rigorous scientific scrutiny over their decisions, thus overcoming the rigid contrast between scientific “populists” and “anti-populists” Western countries are currently experiencing.