The goal to establish the African Medicines Agency (AMA) in 2018 as a Specialised Agency of the African Union (AU) through the Treaty system remains unscathed as African legal and regulatory experts reviewed each of the 36 Articles contained in the AMA Draft Treaty one-by-one in a 3rd Continental Consultation hosted by the Government of Tunisia from 12–13 July 2017. The Consultation also welcomed the participation of Morocco for the first time since being newly admitted to the AU.
After review, the AMA Task Team will finalise the Treaty and submit to the African Ministers of Health as a Working Group of the AU Specialised Technical Committee (STC) on Health Population and Drug Control (HPDC) on 29 August 2017 in Victoria Falls, Zimbabwe. The AMA Draft Treaty will then be considered by the STC on Justice and Legal Affairs in November 2017 and is expected to be ready for endorsement in January 2018 at the AU Assembly of the Heads of State and Government. After endorsement, individual AU Member States will be at liberty to ratify the Treaty to become members of AMA.
The 3rd Consultation was officially opened by the Minister of Public Health in Tunisia, Dr. Samira Merai, who welcomed participants and thanked the AUC for showing strength and commitment in promoting access to quality medicines and addressing the burden of Substandard and Falsified (SF) medical products in Africa. She stated that the Head of State in Tunisia is in support of the work on regulatory systems strengthening and harmonisation, and in particular the AMA which will be a strong continental institution aimed at improving access to quality, safe and efficacious medical products and health technologies, and ensure effective coordination of initiatives to harmonise medical products regulation in Africa. She mentioned that Tunisia is on-board and eager to participate in the establishment of AMA.
‘AMA shall be capable of promoting the competitiveness of local pharmaceuticals in Africa, particularly those aimed at fighting diseases that disproportionately affect out continent’, Dr. Merai said.
She further stated that Africa needs to provide its population with medicines and health services at affordable prices, and create employment at the same time. The state in Tunisia has already developed an Action Plan to promote the country as a medicines exporting nation.
Ambassador Dr. Olawale Maiyegun, AUC Director for Social Affairs said that it is a well-known fact that current weak regulatory systems have an impact on public health in Africa. Hence, AU Member States have to work together to address this and roll back the burden of SF medical products and AMA will help in solving these challenges.
“AMA will draw from the work currently being implemented at national and regional level under the African Medicines Regulatory Harmonisation (AMRH) Initiative, Dr. Maiyegun said.
NEPAD Agency Head of Health Programmes, Margareth Ndomondo-Sigonda thanked the government of Tunisia for the hospitality and for hosting the meeting and emphasised the importance of aligning regulatory systems strengthening initiatives to reduce duplication of efforts and maximise cost effective use of already scarce resources by working collaboratively and in a well-coordinated fashion. Margareth further stated that AMA is critical in providing an enabling regulatory environment for research and development, innovation and local production of pharmaceuticals, optimising competitiveness and expanding markets in Africa.
This 3rd Continental Consultation follows a successful 1st consultation held in Johannesburg, South Africa in February 2017 which was followed by a 2nd consultation which took place at the AU Head Office in Addis Ababa, Ethiopia in March 2017. These consultations are in line with the AMA Task Team mandate in the implementation of the Luanda Commitment by Ministers of Health on setting milestones for the establishing AMA. The AU leadership have expressed optimism to transition the work of AMRH in to AMA.
Africa needs strong institutions that can address the challenges of access to quality, safe and efficacious medical products, and establishment of AMA is an important step in this direction. Once established, AMA will complement National Medicines Regulatory Authorities (NMRAs), Regional Economic Communities (RECs) and Regional Health Organisations (RHOs) in their efforts to establish an enabling regulatory environment for the development of the pharmaceutical industry through better coordination of different partners and stakeholders undertaking medicines regulatory strengthening and harmonisation efforts on the continent.