Benefit assessment of anti-ageing medicines in the European Union: regulatory obstacles and pluralistic alternatives.

Anti-ageing medicine is a new movement in healthcare that has as a focus the development of anti-ageing drugs. These medications, like any novel technological product, must be regulated, demonstrating safety and efficacy. In the European Union, the standard of proof for this purpose is the methodology known as randomised controlled trials, which creates a regulatory environment where such pharmaceuticals face an obstacle related to the resources needed to complete the studies. This situation leads to undesirable consequences related to prolonged wait times, the discouragement of research, and difficulties in achieving certain social benefits. As a possible solution, we propose a regulatory alternative based on evidential pluralism, according to which a combination of evidence of correlation and mechanistic evidence can be sufficient to demonstrate causal relationships, regardless of the methodology used. In this way, as different methods could be employed, the authorisation of medicines targeting this condition would not be hindered, and many of the undesirable social consequences surrounding these products may be resolved.