In a strong endorsement of the work of the African Union Development Agency-NEPAD (AUDA-NEPAD) to strengthen medicines regulators and improve health security on the African continent, the European Union (EU) — including the European Commission, the European Medicines Agency (EMA), and EU Member States Belgium, France and Germany — and the Bill & Melinda Gates Foundation (BMGF) will mobilise more than 100 million euros over the next five years to support the recently established African Medicines Agency (AMA) and other African medicines regulatory initiatives at regional and national levels. This support to strengthening regulatory capacity will improve health security in Africa, including through the expansion of local manufacturing of quality, safe, efficacious, and affordable medicines, vaccines, and other health tools.
The commitments announced today will support the first stages of the continent-wide African Medicines Agency and the further development of African medicines regulatory capacity at regional and national levels. This funding intends to foster collaboration and sharing of technical expertise between the EMA and the AMA and support several African national regulatory authorities (NRAs) to achieve the minimum WHO requirements for effective regulatory oversight for quality local vaccine production.
Cooperation with the African Union as well as national and regional organizations to strengthen Africa's medicines regulators forms a critical pillar of the Team Europe Initiative on local manufacturing and access to vaccines, medicines and health technologies in Africa (MAV+). In this context, the European Union will support the AMA with a comprehensive package of actions to strengthen its capacity, alongside regional and national initiatives to strengthen regulatory capacity in countries such as Rwanda, South Africa, Ghana and Senegal, together with France, Germany and Belgium.
The Bill & Melinda Gates Foundation is likewise providing funding towards the AMA, the regional economic communities (RECs) and certain NRAs, as well as to various technical partners. These commitments will support improvements to the African medicines regulatory landscape by promoting reliance practices, the pooling of scientific expertise, and more efficient and effective processes.
This announcement comes just ahead of the Sixth EU-AU Summit, where the European Union and the African Union will discuss, notably, joint efforts to mitigate the effects of COVID-19 on public health and provide better health care in the future, as well as the reinforcement of the partnership to increase health preparedness and response.
Dr Ibrahim Assane Mayaki, CEO, AUDA-NEPAD said, “Africa has achieved an important milestone by establishing the African Medicines Agency as a continental body that will work with RECs and the Member States to strengthen the medical product regulatory landscape. The achievement is timely considering the urgent need for the continent to meet the demand for quality, safe and efficacious medical products for its population. Lessons learnt during the COVID-19 pandemic showed us that a health-secure continent can only be achieved if we can produce 60% of the total vaccine demand in Africa by 2040. We look forward to the partnership with EU, France, Germany, Belgium, BMGF and others to advance this continental aspiration.”
Jutta Urpilainen, European Commissioner for International Partnerships, said: “The European Commission is proud to support Africa in advancing its aspirations of continental health security and pharmaceutical self-sufficiency through its comprehensive initiative on manufacturing and access to pharmaceutical products. As a key partner, the African Medicines Agency will have a central role in protecting and promoting public health in Africa, ensuring that locally manufactured vaccines and medicines are safe, effective and of high quality.”
European Commissioner for Health and Food Safety Stella Kyriakides said: “Global solidarity and cooperation are the principles on which we should build the global health framework beyond COVID. We know that COVID-19 will not be defeated without them. Strengthening health systems and immunisation capacities of the African continent is at the centre of our work. The European Medicines Agency, as a regulator of global renown, in partnership with African medicines regulators, is building for the future.”
Melinda French Gates, Co-Chair, Bill & Melinda Gates Foundation, said: “Every person deserves access to vaccines and medical treatments, and the assurance that they are safe and effective. This important effort will accelerate equitable access to quality life-saving health innovations in the communities that need them most.”
Emer Cooke, Executive Director, European Medicines Agency, said: “The creation of the African Medicines Agency (AMA) is a really important moment in the continent's journey towards a strengthened regulatory system. The support announced by the European Commission will enable the European Medicines Agency and the network of European national regulatory authorities to reinforce their engagement and support our counterparts in Africa as they make the AMA a reality. With our expertise of more than 25 years supporting the European network in medicine regulation we look forward to contributing to national, regional and continental efforts to promoting public health in Africa.”
Meryame Kitir, Belgium's Minister of Development Cooperation and Major Cities Policy, said: “Together with Team Europe, Belgium is working with its partners from Senegal and Rwanda, including their regulatory authorities, to build a strong and reliable regulatory environment for effective oversight, amongst others for vaccine production. We thereby encourage coordination, harmonisation and mutual reliance between regulatory authorities, and we applaud the leadership of the African Union, the AU Commission, Africa CDC and the African Medicines Agency in this regard. This is an important step forwards to facilitate structural equity in access to quality health products.”
Stéphanie Seydoux, French Ambassador for Global Health, said: “Together with Team Europe, France supports the strengthening of health regulatory agencies in Africa, and in doing so, supports health sovereignty and the development of local manufacturing of vaccines, treatments and other health products. France has already earmarked 7.5 million euros for the strengthening of regulatory agencies over 2022–2025, focusing on West and Central Africa.”
Svenja Schulze, German Federal Minister for Economic Cooperation and Development, said: "Regulatory authorities play a key role for the production and procurement of vaccines. They ensure that vaccines are safe and effective. This is essential for people's confidence in the immunisation campaign against COVID-19, which is now finally gathering momentum in Africa. I am glad that we, as part of Team Europe, are able to support this important initiative, especially in our partner countries South Africa and Ghana."
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