By Baboloki Semele
The African Medicines Regulatory Harmonization (AMRH) programme, under the leadership of AUDA-NEPAD, has made significant strides in combating substandard and falsified medical products (SFMP) across the continent. These accomplishments were highlighted during the 5th Ordinary Session of the African Union (AU) Specialized Technical Committee on Health, Nutrition, Population, and Drug Control (STC-HNPDC-5), which took place in Addis Ababa from August 5-9, 2024.
One of the most notable achievements of the session was the official endorsement of the revised African Union (AU) Model Law on Medical Products Regulation. This endorsement is a crucial development, as it lays the foundation for stronger legal frameworks across Africa, enhancing the continent’s ability to tackle SFMP. The STC-HNPDC-5 has now tasked the African Union Commission (AUC) with presenting the revised Model Law to the STC on Justice and Legal Affairs for further review and potential adoption.
Beyond this key endorsement, the Ministers of Health also adopted a Declaration on Substandard and Falsified Medical Products. This Declaration reaffirms the commitment of AU Member States to confront the challenges posed by SFMP, ensuring that all African citizens have access to safe, quality-assured medical products.
In parallel with the STC-HNPDC-5, AMRH organized a High-level Ministerial Dialogue focused on uniting continental efforts against SFMP. The dialogue was highly successful, marked by engaging discussions and the exchange of experiences among participating nations. A highlight of the event was the identification of new opportunities for collaboration, which are expected to bolster the continent’s unified response to the SFMP threat.
Her Excellency Minata Samate Cessouma, AU Commissioner for Health, Humanitarian Affairs, and Social Development, delivered key remarks during the Ministerial Dialogue. She emphasized the necessity of reforming and implementing national policies to effectively address SFMPs. Commissioner Cessouma urged governments to update and rigorously enforce regulations, calling for the creation of a comprehensive Continental Plan to combat SFMPs across Africa. She also stressed the importance of advocacy, public awareness, and education regarding the risks posed by SFMPs, alongside the development of robust systems for data collection and sharing to enhance monitoring and response efforts.
In addition, Commissioner Cessouma highlighted the need for increased support for research on the health, social, and economic impacts of SFMPs, which would inform policy development and create reparative mechanisms for those affected. She further called for enhanced collaboration among stakeholders to strengthen collective efforts in combating SFMPs.
“These achievements represent a significant step forward in our mission to enhance the medicines regulatory environment across Africa,” said Chimwemwe Chamdima, head of AMRH. “The endorsement of the revised AU Model Law and the success of our Ministerial dialogue are testaments to the growing collaboration and commitment among AU Member States to address the critical issue of Substandard and Falsified Medical Products.”
The AMRH remains committed to working alongside Member States, Regional Economic Communities, and international partners to establish a harmonized regulatory framework. This framework will be crucial in safeguarding public health and ensuring access to quality medical products throughout Africa.
