A socio-epistemological program for the philosophy of regulatory science: the epistemic policies applied to anti-ageing medicines research in the EU

[eng] This doctoral thesis examines the phenomenon of regulatory science through the legislation on anti-ageing medicines in the EU. To this end, it proposes a program of action for the discipline grounded in Steve Fuller’s social epistemology. The program is structured in two phases: (1) a descriptive stage, in which the currently applied epistemic policies are described and the goals they are likely to achieve are analysed; and (2) a normative stage, in which changes at the metalegislative level are proposed with the aim of redirecting the objectives that such policies ought to pursue. The development of the first stage shows how the epistemic policies currently applied by the EMA impose a standard of proof based on the requirement of RCTs, an unfavourable burden of proof that pharmaceutical companies must bear, and various conceptual and ethical constraints, among which the general requirement to conceive of a condition as pathological in order for it to be eligible for pharmacological intervention stands out. Taken together, these elements constitute a regulatory blockade that prevents anti-ageing medicines from being properly assessed and hinders the achievement of desirable goals such as fostering research, reducing age-related suffering, or addressing the characteristic challenges of ageing societies. The second stage proposes legislative reforms aimed at making it possible to achieve these goals. These reforms can be organised into two groups. The first, of a meta-methodological nature, involves replacing the current view of ageing as a natural condition with its recognition as a disease. The second, at a methodological level, advocates for the adoption of an epistemic policy based on evidential pluralism for the assessment of such drugs. In the case of efficacy, given that the use of biomarkers is not a viable option, the proposal is to combine observational and mechanistic studies as an alternative to RCTs. In the case of safety, the strategy would be more closely linked to extrapolation from data already collected in other populations. An epistemic policy of this kind, while it would allow for the evaluation of anti-ageing medicines, may entail new undesirable consequences. Among these, one might note a possible increase in susceptibility to external influences, a rise in the false positive rate, or further erosion of trust in the European pharmaceutical regulatory system. In this context, reassigning the burden of proof to regulatory agencies could be conceived as a measure to mitigate some of these risks, by reducing the financial incentives for researchers and pharmaceutical company developers and promoting the implementation of open access data policies.