Call to Heads of State of the African Union to Ratify and Operationalise the African Medicines Agency Treaty

The members of the African Medicines Agency Treaty Alliance (AMATA), an alliance representing African patients, academia, civil society, and industry, urge Member States as they convene for the 37th African Union (AU) Summit (17th – 18th February 2024) to expedite the unanimous ratification and operationalisation of the African Medicines Agency (AMA) Treaty to ensure timely access to quality medicines that are safe and effective for all patients in Africa.

We commend the progress made in the establishment of the continental regulatory body since the Treaty was adopted at the 32nd ordinary session of the AU Assembly in 2019. To date, 27 countries have ratified the treaty, an important achievement that warrants celebration. However, the ratification and deposit of instruments by all 55 Member States is imperative to unify us as one Pan-African Medicines Regulatory Family and to pave the way for the practical implementation of the Agency. We now call on the remaining family of African Union Member States that have yet to ratify and deposit their AMA Treaty instruments to do so urgently.

The African Medicines Agency will significantly streamline regulatory frameworks across the continent by enhancing the capacity of governments to approve and monitor vaccines, repurposed and innovative medicines and health technologies in a timely manner. Furthermore, a strong unified regulatory system will greatly contribute to combating falsified and substandard medicinal products, a serious threat to the African continent. Coordinated market surveillance, centralised information collection and data sharing between countries will complement and strengthen national efforts to reduce the circulation of falsified products and increase access to safe and innovative products. The establishment of the African Medicines Agency will open up more opportunities to boost local manufacturing capacities, promote country participation in clinical research and foster other scientific development activities.

In light of these considerations, we call for:

1. The 28 remaining AU Member States to ratify the AMA Treaty and facilitate the operational implementation of the continental regulatory system benefiting patients, regulators, and healthcare systems in Africa.

2. The African Medicines Agency Governing Board to establish a framework of engagement with non-state actors and to draw upon all available expertise from academia, research bodies, private sector and community and patient groups to provide technical guidance on specific areas.

3. The African Medicines Agency Governing Board to recognise patients as key partners in the management structures and development of the future Agency.

In ratifying and operationalising the African Medicines Agency Treaty, we embrace the opportunity to reaffirm our commitment to the health, prosperity, and unity of societies in Africa, empowering our continent to thrive. Let us seize the momentum provided by the 37th AU Summit this week to take this crucial step towards a brighter and healthier future for all Africans.