London / Geneva, 5 February 2021 – On the eve of the 34th African Union Summit, two years after the Treaty to establish an African Medicines Agency was agreed, over 40 leading organizations who represent hundreds of thousands of patients, product development partnerships, youth groups, researchers and industry leaders, are urging Heads of State and Government to ratify the Treaty as a matter of priority. Delaying the establishment of an African Medicines Agency (AMA) undermines the timely access to effective, quality therapies, and vaccines for all patients across Africa.
The COVID-19 pandemic has highlighted the importance of regulatory harmonisation 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.
Two years after African Union Heads of State and Government endorsed the treaty establishing the AMA, 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 countries1, and 8 out of the necessary 15 have already ratified it 2.
The agency would follow a similar mandate to other global medicines regulatory agencies, such as the European Medicines Agency and the U.S. Food and Drug Administration. The AMA would provide an enabling environment for research and development, country participation in clinical research and other scientific development activities, as well as open more opportunities to boost local manufacturing capacities. Furthermore, the AMA would help effectively manage the prevalence of substandard and falsified medical products, currently inflicting severe pain and harm on patient’s lives, due to porous borders and ineffective regulatory control.
“The African Medicines Agency is the cornerstone of establishing a sustainable public health system in Africa”, says Kawaldip Sehmi, CEO of the International Alliance of Patients Organizations (IAPO). “A number of leading countries have signed the treaty and close to half of them have so far transposed it into national law. Paradoxically, the ratification process has sometimes been delayed with attention shifting towards the COVID-19 response. That is precisely what the AMA’s mission will be: to help African countries fight disease outbreaks by ensuring that only high-quality drugs, vaccines, and other health-related supplies reach the market and health systems from Cape to Cairo”.
“There have been positive moves towards regulatory harmonization in Africa. However, the establishment of the African Medicines Agency is a critical next step to enable all patients in Africa to have timely access to quality medicines that are safe and effective”, added Adam Aspinall, chair of the Fight the Fakes Alliance.
“Regulatory systems strengthening and harmonization efforts are key for optimizing sustainability in the supply and access of medical products and technologies for diseases disproportionately affecting Africa”, said Karim Bendhaou, Head of Africa Affairs, Merck and IFPMA Chair, Africa Engagement Committee.
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
- Federation of African Pharmaceutical Manufacturers Associations – FAPMA
- Fight the Fakes Alliance
- Generic and Biosimilar Medicines of Southern Africa
- German Medical Aid Organization action medeor V
- Global Pharma Health Fund
- Global Self-Care Federation
- 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
- 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
1 Full list of signatories as of 2 February: Algeria, Benin, Burkina-Faso, Chad, Gabon, Ghana, Guinea, Madagascar, Mali, Morocco, Niger, Rwanda, Sahrawi Arab Democratic Republic, Senegal, Seychelles, Sierra Leone, Tunisia, DRC.
2 Full list of countries who have ratified as of 2 February: Rwanda, Mali, Burkina Faso, Ghana, Seychelles, Guinea, Morocco, Namibia.