21 July 2022
July 19, 2022 –The founding members of the African Medicines Agency Treaty Alliance (AMATA), an alliance representing African patients, academia, civil society, and industry, welcome the decision by the AU Executive Council to nominate Rwanda as the country that will host the African Medicines Agency (AMA) headquarters and Secretariat. We congratulate Rwanda on this milestone.
This a historic moment to bring all stakeholders together and co-create an African Medicines Agency that will truly enhance the capacity of State Parties and AU recognized Regional Economic Communities (RECs) to regulate medical products to improve access to quality, safe and efficacious medical products on the continent.
During the early stages of COVID-19 vaccine authorisation, it was clear that Africa needed a body like AMA to co-ordinate and support State Parties and Regional Economic Communities to quickly assess and licence these vaccines in a coherent and consistent manner. AMATA welcomes AMA as a measure for pandemic preparedness too.
We all know that finding a building is different from making it a home. Let us build this new AMA family home together. We now call upon the remaining family of African Union Member States who have yet to ratify and deposit their AMA Treaty instruments to do so urgently so that we can now build on the current momentum gained with this major milestone.
We now call upon the AU to ensure that:
We have an unanimously ratified Treaty Instrument- all 54 Member States must ratify and deposit to make us one AMA Pan-African Medicines Regulatory Family
Sufficient finances and budgets are established and firmed up quickly for this new Agency
Ensure that the AMA Governing Board is quickly recruited and appointed and mandated to ensure that the AMA is equipped with adequate human resource capacity to operationalise as mandated.
Will continue to build up and strengthen robust national regulatory infrastructures in all African Union Member States Regional Economic Communities
The AMA Board must set up a framework of engagement with non-state actors and to draw upon all available expertise from African academia, research bodies, industry and private sector and community and patient groups to provide technical guidance on specific areas.
Reach out to international development agencies, partners such as the European Union and the international banks to establish a sustainable funding model and implemented to ensure short- and long-term stability of the Agency.
The African Medicines Agency Governing Board to recognise patients as key partners in the management structures and development of the Agency and its NSA engagement frameworks. Like the Patient and Consumer Working Party (PCWP) at the European Medicines Agency and the Patient Engagement Collaborative (PEC) at FDA USA, a Pan-African Patients Working Party needs to be set up.