Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese-Speaking African Countries (BERC-Luso): A pioneering project

Abstract

Biomedical research has a strong impact on a country’s scientific-technological and socioeconomic development. It can make a significant contribution at three different levels: promotion of public health; the exchange of knowledge within the scientific community; and economic/ financial profitability. Africa only attracts ~3.3% of the world’s clinical research. This small proportion is due to, among several factors, the absence of two fundamental aspects: specific robust legislation and capacity for regulatory and ethical evaluation. There are five Portuguese- speaking African countries – Angola, Cabo Verde, Guinea-Bissau, Mozambique and São Tomé and Príncipe. Despite presenting different degrees of clinical research development, these countries show a common serious insufficiency in the minimum conditions necessary for hosting, collaborating or leading biomedical research projects. These countries are also excluded from the support of international organisations for capacity building because of the language barrier. The Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese-Speaking African Countries (BERC-Luso) project has developed methods to build capacity and partnership through research on national law, comparisons with international standards and by issuing recommendations at a national level. Through collaborative intensive training, trainees are taught to become educators at a national level. This, in turn, creates a sustainable impact at country level. BERC-Luso is a pioneering project, owing to a combination of innovative features. The partnership project: (i) was developed exclusively in Portuguese; (ii) involves a large number of African countries, and national and international institutions; (iii) has been further enhanced by the diversity and complementarity of its action plans; and (iv) has also benefited from a broad participatory methodology based on resolution of recipients’ problems by the recipients themselves. It thus stands out as a model for similar future projects.