The BERC-Luso project: Legislative, institutional, and educational impact evaluation.

Abstract

The Biomedical Ethics and Regulatory Capacity Building for Portuguese-Speaking African Countries Project (BERC-Luso) was a four-year project that aimed to enhance biomedical ethics and regulatory capacities in five Portuguese-Speaking African Countries (PSAC). BERC-Luso was developed considering the PSAC scarce number of clinical trials, exploring an untapped potential. The project's interventions focused on three primary areas: legislative, institutional, and capacity building. The common aim was to create attractive conditions for conducting clinical trials, guaranteeing population protection and benefit of the country. The project evaluated national legislative frameworks and recommended strengthening actions. Through implementing top-down and bottom-up approaches, BERC-Luso involved ministries, political stakeholders, policymakers, and diplomatic channels. These strategies prompted legislative initiatives and reforms. The outcomes evaluation reflected a high level of success rate, with 78.59% of the targets being achieved. The impact level was demonstrated by the engagement with stakeholders, resulting in activities that impacted over 71,149 professionals. The project emphasises the need for more investment in capacity-building, reinforcing best practices' implementation at legislative, institutional and training levels. BERC-Luso fostered collaboration between partner countries, contributing to a supportive environment of African biomedical research.