African Medicines Agency gets Shs57b shot in the arm

The European Commission (EC) has announced a contribution of €10 million and Belgium a contribution of €4 million (about Shs57b) to the African Union Development Agency-NEPAD (AUDA-NEPAD).

Monitor understands that the contribution has duly been channeled to the African Medicines Regulatory Harmonisation (AMRH) initiative to continue advancing the establishment of the African Medicines Agency (AMA). 
This support to regulatory strengthening in Africa is part of the Team Europe Initiative on manufacturing and access to vaccines, medicines and health technologies in Africa (MAV+). 

AMRH aids the African Union Commission in establishing AMA governance, while also reinforcing national and regional policy and legal frameworks. It also assists regional economic communities in their harmonisation efforts and joint regulatory activities. 
AMRH also seeks to increase the number of qualified regulatory science professionals and strengthen continental joint evaluation and safety monitoring of health products.  

The grant signing ceremony was held in Brussels, Belgium last month during a high-level event on the European Union (EU) – African Union (AU) partnership on Global Health for equitable access, the EC, Belgian Presidency of the Council of the EU, AUDA-NEPAD and European Medicines Agency (EMA) came together to fortify their support to AMA. 

European Commissioner for International Partnerships Jutta Urpilainen said the partnership will safeguard “public health both on our continents and ensur[e] equitable access to safe and effective health products, including locally produced vaccines and medicines.” 

Belgium’s Minister for Development Cooperation and Major Cities Caroline Gennez noted thus: “During our presidency, Belgium aims to strengthen the EU’s close cooperation with African partners on health. It is important we increase our support for Africa’s Global Health strategy for equitable access with tangible initiatives. That is why we support the African integration project with a focus on health and its formation of its African medicine agency. And, therefore, also focus on social progress.”

Describing the operationalisation of the African Medicines Agency as a “milestone”, Nardos Bekele-Thomas, the AUDA-NEPAD CEO, said: “Harmonised regulatory systems will unlock numerous opportunities for the local pharmaceutical industry.” 

This, Bekele-Thomas added, “will be a shot in the arm for “our ongoing battle against substandard and falsified medical products.”
For Emer Cooke, the executive director of the European Medicines Agency, their “unique experience and expertise in intra-continental medicines regulation” can “help the AMA build an effective regulatory model and practices for the benefit of public health in the African continent.”

There is hope that the partnership will revolutionise local medicine production in Africa, with Lindokuhle Dlamini, the  AMRH Policy Advocacy and Communications Officer, telling Saturday Monitor that the continent will ultimately reduce its “reliance on imported medications.”

“Coupled with the ongoing efforts of AUDA-NEPAD’s African Medicines Regulatory Harmonisation (AMRH) programme, this funding paves the way for efficient regulatory systems that empower Africa to produce and regulate its own medicines,” Dlamini said. 

About AMA

African Medicines Agency (AMA) will be a specialised agency of the African Union. Its mandate will be to enhance the capacity of the state parties and regional economic communities to regulate health products and improve access to quality, safe and efficacious health products on the African continent. As of last month, 27 countries had ratified the AMA treaty. 

The European Union and its member states support regulatory strengthening across Africa and the establishment of AMA through the Team Europe Initiative on manufacturing and access to vaccines, medicines and health technologies in Africa (MAV+). Under the Global Gateway strategy, the initiative has mobilised so far around €157 million in grants for regulatory strengthening and possibly interventions at national and regional level, including from the European Commission to the World Health Organisation, the European Medicines Agency and AUDA-NEPAD. 

AUDA-NEPAD continues to play a pivotal role in advancing the establishment of the AMA. It aligns its efforts and resources with international partners to strengthen regulatory capacity at continental, regional and national levels.