Abstract

In 2024, new legislation introduced significant changes to the rules, procedures and institutions governing research ethics in Brazil. One of its objectives was to limit sponsors’ post-trial access (PTA) obligations. However, a presidential veto weakened this reform. This veto maintained the sponsors’ indefinite duty to provide the tested intervention until it becomes available in the National Health System. In Brazil, where courts often order the public funding for treatments not included in the health system’s lists and protocols, a substantial reduction in the sponsors’ PTA obligations would likely increase litigation seeking state-funded PTA. This dynamic adds an extra layer of complexity to the ethical analysis of the regulation of PTA in Brazil, as its distributive impact on the public health system must be considered. Therefore, any argument for reducing sponsors’ PTA obligations must go beyond simply demonstrating that sponsors do not owe participants an ethical obligation to provide them with indefinite access to the tested intervention or that such obligation discourages research. It must also make a compelling case for why the state, rather than sponsors, should bear the responsibility for funding PTA.