Article Text

Download PDFPDF

  1. Maria do Céu Patrão Neves1,
  2. Maria A Ribeiro2,
  3. Ana S Carvalho3,
  4. Joana Araújo3,
  5. Sofia Oliveira Martins4,
  6. Ana P Martins1,
  7. Filipe Mota Helder1,
  8. Luís Rhodes Baião1,
  9. Jorge Batista1,
  10. Joana De Morais Afonso5,
  11. Katiza Mangueira6,
  12. Carla D Reis7,
  13. Cunhate Na Banga8,
  14. Tânia Sitoie9
  1. 1Ordem dos Farmacêuticos, Lisbon, Portugal
  2. 2Comissão de Ética para a Investigação Clínica, Lisbon, Portugal
  3. 3Universidade Católica Portuguesa – Instituto de Bioética, Porto, Portugal
  4. 4Infarmed – Autoridade Nacional do Medicamento e Produtos de Saúde I.P., Lisbon, Portugal
  5. 5Instituto Nacional de Saúde Pública do Ministério da Saúde de Angola, Luanda, Angola
  6. 6Direção Nacional de Medicamentos e Equipamentos do Ministério da Saúde de Angola, Luanda, Angola
  7. 7Agência de Regulação e Supervisão dos Produtos Farmacêuticos e Alimentares, Cabo Verde
  8. 8Comité Nacional de Ética em Pesquisa em Saúde do Instituto Nacional de Saúde Pública do Ministério da Saúde Pública da Guiné Bissau, Bissau, Guinea Bissau
  9. 9Departamento Farmacêutico do Ministério da Saúde de Moçambique, Maputo, Mozambique


BERC-Luso is a project for building Ethics and Regulatory Capacity, to be developed in four sub-Saharan African countries: Angola, Guinea-Bissau, Mozambique and Cape Verde, and to be implemented in 2018–2021. National Ethics Committees (NECs) and National Regulatory Authorities (NRAs) have been engaged (6 institutions) with the partnership of 4 Portuguese institutions (experts in ethical review and regulatory supervision).

Considering that: 1) clinical trials are fundamental to improve healthcare and develop biomedical research; but 2) can only take place within regulatory systems and under ethical review protocols; and 3) some African countries still lack an adequate legislative framework and the expertise to assure good ethical review and regulatory supervision, it is urgent to change the current situation.

The BERC-Luso project will unfold at four different levels, each aiming at a specific goal in converging dynamics.

  1. Legislative level: Presentation of a comparative study of’the Portuguese Speaking African Partner Countries’ legislation on NECs and NRAs with recommendations for revision in compliance with the international requirements. The goal is to promote adequate internationally recognised legislation.

  2. Educational level: Implementation of an intensive and comprehensive Education Programme, both theoretical and practical, reflexive and normative, ethical and legal, addressing the needs of the countries involved, within their cultural contexts, and in their own mother tongue. The goal is to promote capacity building.

  3. Training level: Organisation of intensive internships, demanding participants to accurately apply everything they have learned to their everyday practice. The goal is to have knowledgeable and skilled experts.

  4. Networking level: Build powerful digital tools to connect partner institutions, staff and participants during the project and beyond, creating a digital repository of documents, and different tools for ethical and regulatory evaluation.

These actions converge to provide internationally recognised legislation and expertise for the development of biomedical research for the benefit of the population.

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.