Patients, Civil Society and Youth Organisations, Products Development Partnerships, Health and Pharmaceutical Industries, and all stakeholders who are striving to improve global public health - welcome the African Medicines Agency (AMA) Treaty made at the 32nd ordinary session of the Assembly of the African Union (AU) in 2019. We now call for all AU Member States to ratify the Treaty, which has already been signed by 19 countries and ratified by 8 countries. This is a strong commitment from AU Member States and we therefore urge all countries of the AU to ratify the Treaty as a matter of priority. 

 

We believe it is critical to establish a continental regulatory body to reduce the complexity of regulatory frameworks and hence to enable all patients in Africa to have timely access to quality medicines that are safe and effective. This new agency is an integral part of the WHO Global Patient Safety Plan 2020-2030. We support the WHO African Region commitment towards the African Medicines Agency delivered by the Kenyan government at the WHO Executive Board in January 2021.

The COVID-19 pandemic has highlighted the importance of regulatory harmonisation in the context of public health emergencies and the need for a competent continent-wide regulatory authority to approve and monitor vaccines, repurposed medicines, innovative medicines and health technologies, in a timely manner.

Furthermore, a strong unified regulatory system would greatly contribute to combating falsified and substandard medicinal products on the African continent. Coordinated market surveillance, centralised information collection and sharing of data between countries is expected to 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, country participation in clinical research and other scientific development activities. 

Considering this, we call for:

1. AU Member States to ratify the AMA Treaty and enable the operational implementation of the continental regulatory system that will benefit patients, regulators, and healthcare systems in Africa. 

 

2. The African Medicines Agency Governing Board to draw upon all available expertise from academia, research bodies, private sector and community and patient groups to provide technical guidance on specific areas of regulatory expertise.

 

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

 

The following organizations support this call (in alphabetical order):

Action Group for Health, Human Rights and HIV and AIDS – AGHA  African Heart Network African Liver Patients Association  African Research Network for NTDs –ARNTD  Association of Representatives of Ethical Pharmaceutical Industries - AREPI Association pour last Lutte contre les Hépatites Virales "ALHV" Centre for Initiative and Development - CFID Taraba Coalition for Access to NCD Medicines and Products Drugs for Neglected Diseases initiative – DNDi Epilepsy South Africa Federation of African Pharmaceutical Manufacturers Associations - FAPMA Fight the Fakes Alliance Global Alliance of Sickle Cell Disease Organisations - GASCDO  Generic and Biosimilar Medicines of Southern Africa German Medical Aid Organization action medeor e.V Global Pharma Health Fund Global Self-Care Federation GS1 Heart and Stroke Foundation South Africa Hepatitis Foundation of Ghana International Alliance of Patients’ Organizations - IAPO International Federation of Pharmaceutical Manufacturers and Associations - IFPMA Innovative Pharmaceutical Association South Africa – IPASA International Pharmaceutical Students’ Federation - IPSF Kenya Association of the Pharmaceutical Industry- KAPI

Kenya Healthcare Federation Les entreprises du medicament -LEEM LiveWell Initiative - LWI Management Sciences for Health Medical Mission Institute Würzburg Mental Health Society of Ghana – MEHSOG Multiple Sclerosis South Africa National Community of Women Living with HIV in Uganda – NACWOLA NCD Alliance Ghana NCD Alliance Kenya Pan African Positive Women's Coalition PATH Patient and Community Welfare Foundation of Malawi - PAWEM Pharmaceutical Society of Kenya RTI International -Center for Global Noncommunicable Diseases Sharecare Ghana South African NCDs Alliance Speak Up Africa Stowelink Inc. Thalassaemia International Federation Uganda Alliance of Patient Organisations Women in Hepatitis Africa World Heart Federation World Hepatitis Alliance QUAMED

The call is still open for organizations to come on sign. Please email us at: info@iapo.org.uk

 

Downloads 

Press Release - Call to Ratify AMA Treaty

 

The Statement  - English

 

The Statement  - French