Biomedical ethics and regulatory capacity building in Africa: the case study of São Tomé and Príncipe.

The Biomedical Ethics and Regulatory Capacity Building for Portuguese Speaking African Countries (BERC-Luso) Project aimed to strengthen biomedical ethics and regulatory capacity in Lusophone African Countries. At the legislative level, it promoted the alignment of national laws with international best practices for biomedical research. At the institutional level, it promoted the establishment and strengthening of National Regulatory Authorities (NRA) and National Ethics Committees (NECs). This project also included professional training to enhance national expertise; however, this article focused primarily on the legislative and institutional developments achieved in São Tomé and Príncipe. It examines how capacity building translated into national regulatory reform. At the project's onset, São Tomé and Príncipe had minimal legislative and institutional frameworks and no specific authorities or legislation in the field. Despite these shortcomings, political commitment and stakeholder engagement enabled major developments. The country established an NEC for scientific research, competent in clinical research oversight and advanced the legal and institutional proposal for an NRA, setting key building blocks for future clinical trials. These advancements underline the transformative potential of capacity-building programs in resource-limited settings. This experience may serve as a model for similar initiatives in countries seeking to strengthen ethical and regulatory frameworks for biomedical research.