Abstract

Anti-ageing medicines are products intended to extend lifespan and healthspan in humans that have a good potential use in public health policies. In the European Union, their development, production and consumption are dependent on regulatory science performed by the European Medicines Agency and its associated epistemic policies. They impose, among other things, an unfavourable burden of proof, a strict standard of proof and meta-methodological constrictions related to some theoretical issues. This results in a distribution of errors that tends to reduce false positives while increasing false negatives, leading to a set of social consequences that are generally accepted when the focus is placed on conventional medicines. However, when the same epistemic policies are applied to anti-ageing medicines, the distribution of errors is imbalanced, and undesirable outcomes like research discouragement and waiting time extensions appear. Three possible strategies that policymakers could implement to unblock the situation are presented for future reflection: the consideration of ageing as a disease, the application of methodological asymmetry and the use of biomarkers during clinical research.