On 5th February 2021, the eve of the 34th African Union Summit, IAPO together with 50 leading organizations who represent hundreds of thousands of patients, product development partnerships, youth groups, researchers and industry leaders, issued a statement urging Heads of State and Governments to ratify the African Medicines Agency (AMA) Treaty as a matter of priority.
The statement – initiated as part of IAPO’s campaign calling to ensure that patients are placed at the centre of medicines regulatory harmonisation processes – is a reminder that further delaying the establishment of an African Medicines Agency undermines timely access to effective, quality and safe medicines and vaccines for all patients across Africa.
Background
The AMA Treaty was adopted by the 32nd ordinary session of the African Union Assembly held in Addis Ababa, Ethiopia on 11 February 2019, but two years on, it remains unratified. Although there has been political support, legal commitment from more countries remains to be secured for the continent-wide regulatory agency to become a reality. The Treaty has so far been signed by 19 countries, but only 8 out of the necessary 15 have ratified it.
The COVID-19 pandemic has highlighted the importance and urgency of regulatory harmonization in the context of public health emergencies and the urgent need for a competent continent-wide regulatory authority to approve and monitor vaccines, repurposed medicines, innovative medicines and health technologies, in a timely manner. The establishment of the AMA presents an opportunity for an enabling environment to effectively regulate the whole supply chain for health products as well as leverage African regulatory assets and capacities to improve access to essential medicines and health products that are safe, effective, affordable, and quality-assured.
IAPO first called for the ratification of the AMA treaty in 2017 at our African Congress in Entebbe, Uganda via The Entebbe Statement. We welcomed the African Union (AU) proposal to establish an African Medicines Agency and called for patients to be recognised as partners and be meaningfully engaged.
Considering the need for patients to be placed at the centre of medicines regulatory harmonisation processes and in line with IAPO’s goal of shaping law, policy and practice for well regulated and safe patient-centred health care, we invite you to support and widely share our statement calling for the ratification of the AMA Treaty.
The call remains open for organizations to endorse and sign. Please email us at: info@iapo.org.uk.
