Mozambique stands out as the most advanced country among Portuguese-speaking African countries (PALOP) in the field of clinical trials, while political instability in Guinea-Bissau and legislative delays in São Tomé and Príncipe create ethical risks for conducting medical research, warned the coordinator of the CT-Luso project, quoted by the Lusa news agency.
The warning was made by Maria do Céu Patrão Neves, who is responsible for the European Commission-funded project, which aims to strengthen the capacity of PALOP countries to conduct clinical trials in a safe and regulated manner.
According to the bioethics expert, Mozambique is positioned as the “strongest” country in the group, standing out for being “more advanced at the regulatory, legislative, and institutional levels, with very well-informed professionals and researchers.”
In second place is Cape Verde, which, according to the coordinator, has shown “truly remarkable progress.” The institutional maturity of the archipelago was evident when the authorities decided to reject an international project because they considered that it did not provide adequate guarantees of ethical protection.
The same project ended up being hosted in Guinea-Bissau, where the institutional framework is considered more fragile, revealing the disparities that exist between Portuguese-speaking African countries in the field of scientific regulation.
Growing investment, but challenges remain
The expert also highlighted the investments made by Angola to develop this sector, emphasizing that each country has its own realities and challenges in the process of strengthening scientific and institutional capacities.
In contrast, São Tomé and Príncipe and Guinea-Bissau face structural difficulties that hinder the creation of effective mechanisms to protect populations involved in clinical studies.
“In the case of Guinea-Bissau, much has been done, but then it comes up against political power,” explained Maria do Céu Patrão Neves, adding that political instability in the country has prevented the approval and regulation of essential documents to frame clinical research.
Despite this, she was keen to stress that the problems are not due to a lack of commitment on the part of local professionals. “The professionals are working hard,” she said.
In São Tomé and Príncipe, although there is “a huge amount of legal documentation in the pipeline,” the processes face significant delays in parliamentary and governmental approval, delaying the implementation of a robust legal framework.
Ethical risks in contexts without adequate legislation
For the coordinator of the CT-Luso project, legislative disparities between countries create an environment conducive to ethical risks. In the absence of robust laws, there is a danger that large international consortia will conduct research without adequate safeguards for participants.
Among the risks identified are the absence of insurance for volunteers, the lack of sharing of benefits and scientific data, or even the impossibility for populations to have access to drugs that show positive results during studies.
“In Guinea-Bissau, research has long been conducted completely outside the legislative framework, which does not exist,” warned the expert, adding that without adequate legislation, national authorities find it difficult to prevent abuse and ensure the protection of communities.
Asked about a US-funded study in Guinea-Bissau, considered “unethical” by the World Health Organization, which analyzed the reaction to hepatitis B in vaccinated and unvaccinated newborns, the coordinator declined to comment on the specific case because she was not familiar with the details. Nevertheless, she warned that similar situations could recur if there is no solid legal framework.
“There will be others behind this case,” she said, arguing that the Guinean government should approve the work already done by national experts to ensure safe clinical trials.
Clinical trials can bring economic and health benefits
Despite the risks, Maria do Céu Patrão Neves pointed out that clinical trials can bring significant benefits to the countries that host them, including investment, strengthening of scientific capabilities, and improvements in healthcare provision.
The CT-Luso project, successor to BERC-Luso, has teams working directly with the governments of the PALOP countries to create legal requirements that allow countries to negotiate compensation with pharmaceutical companies, including future access to tested medicines.
The expert also considered the operationalization of the African Medicines Agency (AMA), an entity similar to the European Medicines Agency, to be “good news,” as it should strengthen the safety and regulation of medicines on the continent.
However, she pointed out that clinical trials represent a phase prior to the drug approval process, requiring each country to have national regulatory institutions and adequate legislation to avoid a “legal vacuum.”
As part of this legislative harmonization effort, the CT-Luso project is holding a workshop on Wednesday (11) a workshop dedicated to “Legal and institutional recommendations for Portuguese-speaking harmonization in the area of clinical trials,” an initiative that aims to bring the legislation of Portuguese-speaking African countries closer together, attract foreign investment, and reduce bureaucracy, without compromising safety and scientific ethics standards.
