Documentation
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.
Ethics
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 Humans
Download DocumentCouncil of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine
Download DocumentCouncil of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes
Download DocumentUNESCO, Universal Declaration on Bioethics and Human Rights
Download DocumentLegal documentation
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 Committee
Download DocumentCNECV - National Council of Ethics for Life Sciences
Download DocumentEthics Committees
Download DocumentClinical Research Law
Download DocumentEU REGULATION on Clinical Trials
Download DocumentEU REGULATION on Data Protection
Download DocumentLaw 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 trials
Download DocumentLegal documentation – Angola
Law No. 21-B/92, dated August 28 (National Health Service Framework Law)
Download DocumentPresidential Decree No. 180/10, dated August 18 (National Pharmaceutical Policy General Framework Law)
Download DocumentLegal documentation - Cape Verde
Regulatory Decree No. 23/2014, dated June 10
Download DocumentDecree-Law No. 26/2007, dated July 30 – National Health Research Ethics Committee (CNEPS)
Download DocumentLaw No. 41/IV/2004, dated April 5 – National Health Service Framework Law (LBSNS)
Download DocumentResolution No. 5/2008, dated February 18 – enacted the National Health Policy
Download DocumentDocumentação jurídica - Guinea-Bissau
Information not availableLegal documentation - Mozambique
Law No. 12/2017, dated September 8 – Law on Medicines, Vaccines and Other Biological Products for Human Use
Download DocumentComparative 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.
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Comparative Legislative Study, Part 2.pdf
The second part reinforces the aspects that contribute to legislative strengthening in the international context.
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