The Lusophone International Symposium “Regulatory and Procedural Harmonisation for Clinical Trials: Is it Possible?” took place on 25 September at the Portuguese Pharmaceutical Society in Lisbon, gathering 110 participants on site and 120 online. The initiative marked the first anniversary of the CT-Luso project – Ethical and Regulatory Capacity Building in the PALOP – funded by the European Union under the EDCTP3 programme. The project aims to align regulatory and ethical processes in clinical research across Portuguese-speaking African countries.
The event brought together health authorities, ethics committees, experts, and Ambassadors from Portugal, Angola, Cape Verde, Guinea-Bissau, Mozambique, and São Tomé and Príncipe, fostering the exchange of experiences, updates on recent developments, and the strengthening of Lusophone networks. See the photo gallery here.
From Multilateralism to the Opening Session
In the opening session, Helder Mota Filipe, President of the Portuguese Pharmaceutical Society and Coordinator of CT-Luso, highlighted the project’s collective effort to bring systems closer together and align practices among Lusophone countries, promoting proximity, technical cooperation, and regulatory harmonisation in clinical research.
“From this convergence will emerge not only better conditions for sponsors, but also tangible benefits for health systems, researchers and, above all, for the populations,” he stressed.
Next, Maria do Céu Patrão Neves, Project Coordinator, noted that this represents a unique opportunity for the Portuguese-speaking African countries that cannot be postponed:
“Each euro invested in clinical trials yields a 200% return, and the PALOP have enormous growth potential — after all, Lusophone Africa represents only 0.04% of clinical trials compared to 2.02% for the African continent as a whole.”
André Dias Pereira expressed gratitude for the invitation extended to the Biomedical Centre of the University of Coimbra to collaborate on the legal component of CT-Luso, emphasising the importance of the project’s “dynamic of multilateralism and mutual respect” in “a world in transformation and in the process of rebuilding its balances.”
Rui Santos Ivo, President of INFARMED, and Pedro Barata, Vice-President of CEIC, also addressed the symposium, underlining the importance of strengthening cooperation among Portuguese-speaking countries to advance clinical research within the Lusophone sphere.
Ana Isabel Xavier, Secretary of State for Foreign Affairs and Cooperation, welcomed the initiative in a video message, stating:
“Health diplomacy is one of the most valuable tools we have to achieve the Sustainable Development Goals of the 2030 Agenda, ensuring that no one is left behind.”
Lusophone Legal-Institutional Overview
Following the opening session, speakers from different countries took the stage to outline the “Lusophone Legal-Institutional Overview”, moderated by CT-Luso consultant Maria Alexandra Ribeiro.
From Angola, Mutombo Mavunza, Pombal Mayembe, and Moisés Francisco stressed the need to approve specific national regulations, accompanied by enhanced technical and institutional capacities. They also highlighted the importance of active participation in the Lusophone network and of ensuring ethical and safe clinical trials.
Cape Verde was represented by João Semedo, Eduardo Tavares, and José António Reis, who affirmed that Lusophone regulatory and procedural harmonisation is not only possible but imperative — achievable through the adoption of internationally recognised ethical principles with binding legal force, adapted to local contexts without compromising standards.
From Guinea-Bissau, Miguel Pereira, Carlos Costa, and Mouhammed Djicó pointed out institutional progress already under way and identified strategic legal gaps in biomedical research legislation — essential to safeguard research participants.
Mozambique was represented by Virgílio Uamba, Tânia Sitoie, and Esperança Sevene, who underlined the country’s advances in clinical trial legislation and clarified responsibilities. They also referred to ongoing measures to streamline reviews and improve the research environment, while calling attention to the need for digitalisation of procedures.
From São Tomé and Príncipe, Neidyne Afonso, Hironisia dos Santos, and Eula Maquengo emphasised the importance of learning from other PALOP countries and adapting local legislative solutions. They noted that harmonisation is feasible provided there is alignment of requirements among regulatory authorities and optimisation of internal processes — from study management to participant recruitment and data handling — to improve national system efficiency.
Diplomacy and Political Commitment
During the round table with African Ambassadors accredited in Portugal, moderated by Maria do Céu Patrão Neves, Esterline Gonçalves Género, Ambassador of São Tomé and Príncipe, recalled that science can be a driver of development:
“The Government of São Tomé and Príncipe sees this project not only as a scientific initiative, but as a genuine opportunity for national development in this field.”
Stella Novo Zeca, Ambassador of Mozambique, called for Lusophone cooperation:
“We must break barriers, reduce bureaucracy, and strengthen ties between our countries. Only then can we turn intentions into results.”
She added:
“We are in a new era — all our countries have now celebrated 50 years of independence. It is time to do things differently.”
Artur Silva, Ambassador of Guinea-Bissau, brought education into the discussion:
“Between 2014 and 2024, more than 7,500 young Guineans came to study in Portugal, but only 159 completed their courses — around 2%. It is essential to create conditions for students to finish their training and return to contribute to clinical research in their country.”
Ana Pires, Chargée d’Affaires of the Embassy of Cape Verde, highlighted that to advance clinical trials in Lusophone Africa,
“it is not enough to have institutions and legislation; we need funding. Once support is approved, we must ensure a proper regulatory framework and promote best practices. In Cape Verde, we already have that framework — now we must bring theory into practice.”
The symposium concluded with remarks from Esperança Sevene, Scientific Coordinator of the project, who underscored the importance of using the Portuguese language in legislative drafting and standard-setting to prevent translation inaccuracies and ensure that policymakers clearly understand legal texts.
The event also featured the opening of the exhibition “Meanings of Lusophone Africa”, showcasing artistic and cultural objects — including traditional crafts and culinary items from participating countries — highlighting the cultural and identity dimension of the initiative.
