Should the European Medicines Agency consider ageing a disease? Guillermo Marín Penella Bioethics, 2024 The classification of ageing as a disease is fundamental to developing new pharmacological strategies that can target said phenomenon. The European Medicines Agency does not do this and maintains a questionable perspective based on the traditional naturalistic argument and the value‐free ideal. An alternative is proposed which, inspired by consequentialism, is committed to considering ageing as a disease in European regulatory contexts as long as the ethical consequences are desirable. Within a realistic framework, I show that making this decision would have moderate positive effects such as increased knowledge about antiageing pharmacology or potential greater chances of completing vital projects. Furthermore, we will see that the main arguments used by critics to show that the negative effects outweigh the positive ones are not sound. Therefore, I conclude that it would be beneficial for the European Medicines Agency to change its position on ageing.
The Epistemic Policies of Anti-Ageing Medicines in the European Union Guillermo Marín Penella Health Care Analysis, 2024 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.
A socio-epistemological program for the philosophy of regulatory science Guillermo Marín Penella Metaphilosophy, 2023 This paper presents a program of action for the philosophy of regulatory science, based on a general theory of social epistemology. Two candidates are considered. The first one, offered by Alvin Goldman, is not fit for our purposes because it is focused on a veritism incompatible with non‐epistemic aims of regulatory science. The second, championed by Steve Fuller, sociologically investigates the existing means of producing knowledge, to modify them with the goal of obtaining democratic aims through action on a legislative meta‐level. The program has been built upon this procedure, instantiated by the identification, characterization, and modification of epistemic policies.
