Medicines, including those intended for the treatment of cancer, are tightly regulated. Such regulation, historically linked to disasters due to unsafe medicines, evolved to cover all aspects of research around the quality, safety and efficacy of candidate medicines. This chapter intends to give an introduction on what regulators do and where the ethical foundations for regulating medicines might be searched. Some specific dilemmas will be explored, such as (i) whether at all, and if so subject to which conditions, research on animals is justified; (ii) what to do when potentially useful data on a medicine were collected unethically; (iii) which additional ethical challenges are posed by the fact that regulators have to make decisions on a medicine under uncertainty; and (iv) how to account for patients' preferences (and their heterogeneity) in regulatory decision-making. An overview of emerging topics such as use of healthcare data and open science is also proposed. While not intending to cover all arguments in the complex conversation around the regulation of medicines for cancer (let alone, around the regulation of medicines in general), this chapter aims to give a basis for further reading.
Keywords: Autonomy; Gatekeeping; Good clinical practice; Regulation; Research on animals.