Africa CDC’s Platform for Harmonized Health Products Manufacturing (PHAHM), in collaboration with the Team Europe Support Structure (TESS) MAV+, organised a Study Tour on Policy Frameworks for Health Products Manufacturing to Europe in April.
From analysing the policy mechanisms, regulatory environments, and frameworks that sustain and enhance the health products manufacturing ecosystem, participants gained a more comprehensive perspective on the interplay between manufacturing and governance—one of the eye-opening lessons ushered in by the tour.
More than 20 representatives from African Union (AU) Member States, Regional Economic Communities, African Union organs, Africa CDC, AUDA-NEPAD, the African Medicines Agency, and the African Union Commission were among the participants.
Speaking on the study tour, Dr Anthony Ayeke, Programme Manager, Health and Human Development Section at the European Union Delegation to Nigeria and ECOWAS in Abuja, said he hopes to contribute towards enhancing vaccine and health product manufacturing capabilities in Africa by ensuring there is a commitment to sustainable healthcare development that respects local contexts and needs.
“Collaboration is key,” said Dr Ayeke, reflecting on the week-long tour in Belgium and the Netherlands. “Successful vaccine production relies on strong partnerships between governments, industry or private sector, and academia,” he said, adding that collaborative networks, such as the Regional Capability and Capacity Networks, facilitate knowledge sharing and resource pooling.
In 2021, the Partnerships for African Vaccine Manufacturing (PAVM) was established by the AU, under Africa CDC, with the goal of ensuring the production of 60% of Africa’s vaccine needs by 2040.
Africa CDC, in collaboration with the Clinton Health Access Initiative and PATH, conducted an in-depth assessment of the vaccine suppliers’ landscape to understand vaccine manufacturing in Africa and identified key ecosystem interventions needed, including improving infrastructure, technology transfer, regulatory frameworks, financing, and demand.
One of the areas of learning was understanding how Europe navigates policy frameworks and how lessons learnt can be applied in individual African countries, regionally or continentally.
The serial study tours are geared towards helping African experts share and exchange knowledge with counterparts in Europe.
Dr Ayeke said he learnt that robust yet flexible regulatory frameworks in Europe—such as those at the European Medicines Agency and the Federal Agency for Medicines and Health Products in Belgium—enable rapid response to public health crises. “Timely approvals of 210 days and adaptations within regulatory processes through central, national, and decentralised application procedures are crucial for efficient health responses,” he said.
Continuous investment in research and development leads to innovation in health product manufacturing, including funding, incentives for biopharmaceutical research, and investment in new technologies, such as those seen at Universiteit Utrecht in the Netherlands, he said.
Janet Byaruhanga, Senior Programme Officer at AUDA-NEPAD, the African Union Development Agency, said a skilled workforce is crucial, but regulatory maturity remains a foundational enabler for achieving local manufacturing capabilities.
Byaruhanga said the study tour exposed the need for policies that support African pharmaceutical industries, which are still in early development. “Manufacturers often lack access to technology, capital, skilled labour, intellectual property rights, and effective partnerships. Policy collaboration between universities, regulators, and industry must be strengthened,” she said, recommending that future study tours focus more on the needs of the industry and actual manufacturing processes.
Dr Salma Osman, Policy Officer at the African Medicines Agency, appreciated the relevance of the study tour to her work and identified local manufacturing as a key gap. Dr Osman suggested that future tours be more thematically specific, covering areas such as regulatory frameworks, administrative processes, and scientific or manufacturing development separately to complete the full cycle. She said she would have loved to see African foreign direct investors participating in the discussions to better understand how to tackle the access to finance required to develop sustainable local manufacturing.
The tour demonstrated practical systems for strengthening local manufacturing, said Dr Fatuma Adan, Head of Mission to Kenya at the Intergovernmental Authority on Development (IGAD), one of the eight Regional Economic Communities (RECs) of the African Union. She was particularly struck by the regional and inter-institutional cooperation needed among regulators, manufacturers, and the private sector. The discussion with the European Commission’s Health Emergency Preparedness and Response Authority (HERA) and the Critical Medicines Alliance stood out to her for its cross-border pandemic response and how lessons were shared between Europe and Africa.
Fasika Alemu, Regulatory Strengthening and Market Shaping Expert at Africa CDC, said the example of HERA on supply chain management—such as contingency stock and stockpiling—was insightful and is crucial for managing frequent outbreaks in Africa. “I admired how Belgium, the Netherlands, and EMA have achieved harmonisation in regulatory processes, working in synergy rather than competition, leading to reduced costs, increased access, and minimised shortages,” he said.
Dr Safouane Benazzouz, Head of the Production Department at Institut Pasteur d’Algerie, focused on the Critical Medicines Act and pandemic preparedness efforts. He emphasised that beyond capacity building, investing in infrastructure and ensuring policy adaptability were key to effective pandemic response and preparedness.
There is a need to bridge the gap between training infrastructure and practical expertise, said Valentine Atonde Epse Oladimeji, Senior Programme Officer at ECOWAS. She suggested leveraging biotechnology training centres in Europe and ensuring African trainees benefit as well. She also pointed out that partner selection in regions like ECOWAS is critical and should be strategic, such as involving other technical officers in future training programmes.
Redefining “local” to mean the African continent, not just individual countries, would be useful, said Ricardo Afonso, Head of the Inspection and Supervision Department at the National Medicines Regulatory Authority in Mozambique. After witnessing the EU experience, Afonso stressed the importance of harmonisation and mutual trust among African nations, just as European countries rely on each other. “Building this intra-continental confidence is crucial for medicine acceptance and regulatory trust,” he said.
Sandra Haile-Brugger, Access to Finance Expert at Africa CDC, shared the same sentiment, that the strength of the European model lies in trust and collaboration between countries and institutions. “Such a cooperative framework is something Africa needs to adopt. A key lesson from EMA was that when decisions are collectively adopted by all member states, implementation is faster and more impactful,” she said.
The tour was an eye-opener for Solomon Onen, Manager of Good Manufacturing Practices at the National Drug Authority of Uganda, on global developments in pharmaceutical production. He recognised similarities between Europe’s Critical Medicines Act and Africa’s current goals. Moving forward, he advocates for a continental mapping of manufacturing capabilities, training institutions, and laboratory networks, so countries know where to go for specific needs. Institutionalising training facilities within universities was flagged as essential for long-term sustainability.
“I left the tour with a sense of hope,” said Marta Ajulong, Commissioner of Pharmaceuticals and Natural Medicine at the Ministry of Health, Uganda. “African countries like Senegal and Algeria are already producing antigens, that is an encouraging sign.” She praised the tour for facilitating intercontinental exchange and recommended ongoing communication and follow-up. Ajulong also noted interest from Uganda in strengthening local manufacturing and stressed the importance of designing training programmes with clear outcomes.
There is significant opportunity in Africa for European companies to invest in local production facilities and partnerships, which could lead to mutual benefits and market expansion, specifically for Nigeria and Algeria, said Dr Ayeke.
EU and EU Member State organisations like GIZ, EF, TESS, and HERA can play an essential role in providing technical support and funding for capacity building in Africa’s health sector, he said.
“Europe should understand the unique challenges faced by African countries concerning health access and equity. Collaborations should aim to address these disparities in meaningful ways, including for paediatric formulation considerations,” Dr Ayeke added.
