by Giuliana Miglierini
Cameroon has been the fifteenth African country to formally ratify on October 5th the Treaty for the establishment of the African Medicines Agency (AMA). The reaching of this target enables the implementation phase of the project, that should lead AMA to be operative in 2022. The Treaty is now going to come into force 30 days after the deposit of the last instrument of ratification and will lead to the activation of all conditions needed to run the Agency.
Twenty-six African countries (mainly Francophone) are supporting the initiative (on a total of 55); three countries still need to just formally inform the African Union (AU) of the ratification, while other eight are expected to ratify the already signed Treaty. Among important African countries that have not yet supported the creation of AMA are Ethiopia, Nigeria and South Africa.
A regulatory Agency to support the African growth
The Treaty was signed in 2019 by the Assembly of Heads of State and Government of the AU; AMA will represent the central African regulatory body in charge of the supervision of medicines’ development, production and approval in adhering countries, a key milestone for the development in the Continent of a robust vision of the entire life cycle of medicinal products.
The African Medicines Agency will add to the already existing Africa Centres for Disease Control and Prevention (Africa CDC), the specialised technical institution of the AU established in 2016 and launched in 2017 as a platform to share and exchange knowledge and lessons from public health interventions. The activities of AMA shall also contribute to the proper functioning of the African Continental Free Trade Area (AfCFTA), the largest integrated trading area in the world which should represent the basis for the creation of an African Economic Community (expected to occur by 2028).
Africa should experience a rapid growth of the urbanising population, with total projections at 1.2 billion people. Substandard and counterfeited medicines still remain a relevant issue to be addressed by the newly born Agency, with estimates of over US$30 billion annual earnings (data WHO 2017). A main reference for AMA’s activities shall be also found in the Pharmaceutical Manufacturing Plan of Africa (PMPA), endorsed by the Heads of State and Government at the summit in Accra in 2007 and aimed to support a robust framework for the creation of an African pharmaceutical industry.
The process to create the African Medicine Agency started in 2014, with the goal to prioritise investment for regulatory capacity development and find convergence and harmonisation of medical products regulation in countries adhering to the Regional Economic Communities (RECs), within the context of the African Medicines Regulatory Harmonization (AMRH) initiative.
AMA will act as a specialised agency of the African Union – exactly as the European Medicines Agency is for the EU – with its own rules, membership and resources to enhance the capacity of member states and RECs to regulate medicinal products. Its activities shall help the coordination of on-going regulatory systems, provide regulatory guidance, and improve access to qualitative, safe and efficient medicinal products on the continent. The city that will host AMA will be selected upon examinations of the bid offers received by members of the Conference of the State Parties.
The Conference shall also act as the highest policy-making organ of the AMA, entitled to determine the composition, sessions, functions and terms of office of the AMA Governing Board. This last body will include five Heads of National Medicines Regulatory Authority (NMRAs) from each region, one Regional Economic Community (REC) representative, one representative of Regional Health Organization (RHOs), one representative of National Committees Responsible for bioethics on rotational basis and the Commissioner for Commissioner for Health, Humanitarian Affairs and Social Development (HHS) at the African Union Commission (AUC). The Conference of the State Parties shall also appoint AMA’s Director General, upon recommendation of the Governing Board.
Open issues waiting for the action of AMA
The weakness and fragmentation of current legislative frameworks active in African countries, is leading to redundant and/or duplicate procedures, slow and inefficient medicine registration processes, and limited technical capacity. These critical issues were already been identified in 2009 by the African Medicines Regulatory Harmonisation initiative (which is part of the PMPA).
An article published in the Journal of Pharmaceutical Policy and Practice discusses the actual status and the challenges and regulatory readiness be faced during the implementation of the African Medicines Agency.
The AU Model Law on Medical Products Regulation established by the African Union shall represent the reference for the alignment of national legislative frameworks, in order to proceed towards a better harmonisation of rules governing the pharmaceutical sector. Under the current status manufacturers submit the regulatory dossiers in each country, as no mutual recognition procedure is in place for the approval of medicinal products. This leads to a great duplication of efforts, with higher costs and time-consuming procedures.
The Sahrawi Republic is the only African country not to have a national regulatory authority or an administrative unit in charge of this type of functions; the great majority of countries (>90%), explains the article, have minimal to no capacity, and only 7% have moderately developed capacity, thus highlighting the importance for the new central Agency to provide support also in the form of training provided to national NMRAs. Ghana and Tanzania are the only countries to possess NMRAs operating at maturity level 3 (over a total of 4) of the WHO’s Global Benchmarking Tool (GBT). Fragmentation is also present in the type of medicines falling under the mandate of each NMRA, including veterinary drugs, traditional and herbal products, foods, cosmetics, food supplements, etc. Issues shall also to be addressed for their registration of innovative medicines, i.e. biosimilars, vaccines or advanced therapies.
Among recommended priorities for AMA is the assessment of the current status of implementation of the AU Model Law by AU member states, the examination of the enabling factors and challenges encountered in implementing the Model in each country, the analysis of factors impacting on the ratification of the Treaty, a comparative study to gain experience from the implementation of other continental initiatives, and an investigation of African NMRAs’ expectations, perceived contributions in/to AMA and perceived benefits for each country, and which may potentially derive from the new Agency.
A partnership for health innovation in Africa
The development of a framework to strengthen the African capacity for drug discovery and development – by scaling existing initiatives and identifying new development opportunities for young and mid-career scientists – is central to the new three-year partnership launched by the H3D-Foundation (H3D-F, established to reduce barriers for health innovation in African countries) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
The project will start from the results achieved up to now by the University of Cape Town Holistic Drug Discovery & Development (H3D) centre, the only integrated drug discovery and development platform in Africa. The new partnership with IFPMA shall contribute to expand this capacity.
Focusing on infections, an area highly relevant medical need in Africa, local research currently represents approx. 2% of the global effort on new infections. There are 250 research sites and 73 vaccine clinical trials active in Africa, but less than 10 universities provide vaccinology courses and only two local universities engage in vaccine-related pre-clinical studies.