The BERC-Luso’s first Work Package – Legislation / De legis – required the collection of all the current legislation on biomedical research and/or clinical trials and on the ethical and regulatory institutions of this area from Portugal and Portuguese-speaking African Countries.
This documentation was the basis for the preparation of a Comparative Legislative Study, which was also supplemented by international legal and ethical documentation that reflects on the international best practices of this field.
The most widely accepted ethical or legal-ethical documentation has been prepared by international institutions in which most countries are represented.
CIOMS, International Ethical Guidelines for Health-related Research Involving HumansDownload Document
Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and MedicineDownload Document
Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health PurposesDownload Document
UNESCO, Universal Declaration on Bioethics and Human RightsDownload Document
We have listed below the legislation on biomedical research and/or clinical trials and also on the regulatory and ethical review agencies. This is the legislation currently in force in Portugal, Angola, Cape Verde, Guinea-Bissau and Mozambique.
Legal documentation - Portugal
CEIC - Clinical Research Ethics CommitteeDownload Document
CNECV - National Council of Ethics for Life SciencesDownload Document
Ethics CommitteesDownload Document
Clinical Research LawDownload Document
EU REGULATION on Clinical TrialsDownload Document
EU REGULATION on Data ProtectionDownload Document
Law No. 73/2015, dated July 27 – first amendment to Law No. 21/2014, dated April 16, which enacted the clinical research law and established the terms and conditions under which monitors, auditors and inspectors may access the register of participants in clinical trialsDownload Document
Legal documentation – Angola
Law No. 21-B/92, dated August 28 (National Health Service Framework Law)Download Document
Presidential Decree No. 180/10, dated August 18 (National Pharmaceutical Policy General Framework Law)Download Document
Legal documentation - Cape Verde
Regulatory Decree No. 23/2014, dated June 10Download Document
Decree-Law No. 26/2007, dated July 30 – National Health Research Ethics Committee (CNEPS)Download Document
Law No. 41/IV/2004, dated April 5 – National Health Service Framework Law (LBSNS)Download Document
Resolution No. 5/2008, dated February 18 – enacted the National Health PolicyDownload Document
Documentação jurídica - Guinea-BissauInformation not available
Legal documentation - Mozambique
Law No. 12/2017, dated September 8 – Law on Medicines, Vaccines and Other Biological Products for Human UseDownload Document
Comparative Legislative Study
The Comparative Legislative Study was based on the collection of all the legislation on biomedical research and/or clinical trials and on the relevant ethical and regulatory agencies. This legislation, which is currently in force in Portugal and Portuguese-speaking African Countries, was also compared to the international best practices in this field.
Comparative Legislative Study, Part 1.pdf
The first part of this study highlights the international ethical and legal guidelines of this field.
Comparative Legislative Study, Part 2.pdf
The second part reinforces the aspects that contribute to legislative strengthening in the international context.