Biomedical Ethics and Regulatory Capacity Building in Africa: The Case Study of São Tomé and Príncipe

Biomedical Ethics and Regulatory Capacity Building in Africa: The Case Study of São Tomé and Príncipe

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The scientific journal Global Bioethics has published the article‘Biomedical ethics and regulatory capacity building in Africa: the case study of São Tomé and Príncipe’, authored by Jorge P. B. Batista, Adionilde Aguiar, Vânia Castro, Jeryson Costa, Isaulina Barreto and Maria do Céu Patrão Neves.

The publication analyses the progress made in strengthening the ethical, legislative and institutional capacities required for the development of biomedical research in São Tomé and Príncipe under the [BERC-Luso project], the predecessor to CT-Luso.

Although São Tomé and Príncipe formally joined the project only in February 2020 and started from a context marked by the absence of specific legislation and fully established structures to oversee clinical research, the country made significant progress within a relatively short period.

Key developments included the establishment of the Ethics Committee for Health and Scientific Research and the approval of its internal regulations, as well as progress on legislative and institutional proposals concerning the national regulatory authority and the framework for clinical research. Of the 14 objectives defined by the national team, 13 were fully achieved and one was partially achieved.

The article highlights BERC-Luso’s contribution to consolidating national capacities and demonstrates the potential of cooperation among Portuguese-speaking countries to promote stronger ethical and regulatory systems. This work is being continued through CT-Luso, which seeks to further develop and consolidate the progress achieved.

See the article here.

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