Background
The African Union (AU) Assembly decision 55 taken during the Abuja Summit in January 2005 mandated the AU Commission to develop a Pharmaceutical Manufacturing Plan for Africa (PMPA) within the framework of NEPAD. The PMPA articulates a regional strategy to pool the talents and investments of groups of countries, putting them in the driver’s seat to determine and manage research, production and access of medicines as well as to promote innovation (‘Strengthening Pharmaceutical Innovation in Africa’, AU, COHRED, NEPAD). Medicines regulatory harmonisation is a key component of the African Union’s PMPA, which was approved by the AU Conference of Ministers of Health in 2007 and aims to enable African countries to fulfil their national obligations to provide all citizens with safe, quality and efficacious essential medicines.
As part of this momentum, the African Medicines Regulatory Harmonisation initiative continued to develop at a NEPAD and Pan-African Parliament (PAP) consultation meeting in February 2009, (Birchwood, Johannesburg, South Africa) which was hosted in collaboration with a Consortium of partners, and attracted representatives from nine of the continent's Regional Economic Communities (RECs) and over 40 national medicines regulatory authorities (NMRA). This consultation provided a strong endorsement for the consensus plan that emerged articulating the way forward towards medicines regulations harmonisation on the continent.
The AMRH initiative gave rise to the AMRH Programme, through which the NEPAD Agency - as the technical arm of the African Union, in collaboration of partners, is supporting African RECs and countries to lead medicines regulatory harmonisation in their respective countries and to respond to the challenges of increasing access to essential medicines.
Thus in keeping with the African Union’s strategy for development and collaboration across countries, the AMRH Programme works through the continent’s political structures, in the form RECs, which themselves promote common trade, economic and market opportunities to those countries (aligned geographically) that constitute their member states. In addition to economic development, many RECs also work to promote social development and are increasingly active in the health field.
Context
There are significant disparities in health and life-expectancy between low-income African countries and high-income countries. Furthermore communities in Africa have insufficient access to essential medicines, a situation compounded by fragmented medicines regulatory systems which are difficult to navigate. The AMRH Programme assists African countries and RECs to respond to the challenges of increasing access to essential medicines by building effective medicines regulatory systems through harmonisation and regulatory capacity building. This constitutes an important, but neglected area of access to medicines.
In harmonising medicines regulations, a positive impact will be made on:
- Access: Communities get quicker, greater access to priority essential medicines of good quality.
- Availability: The availability of affordable essential medicines can be improved through simplified, harmonised, efficient and transparent regulatory approval processes.
- Affordability: With more generics (lower priced) on the market, patients can achieve greater savings. Governments and donors can enjoy cost savings from subsequent downward pressure on prices through enhanced competition and pooled (shared) procurement.
How we work
The AMRH Programme is being implemented through RECs in collaboration with partners namely the African Union Commission (AUC), Pan African Parliament (PAP), World Health Organization (WHO), World Bank (WB), Bill and Melinda Gates Foundation (BMGF), UK Department for International Development (DFID) and Clinton Health Access Initiative (CHAI). Other partners that have shown interest to support the AMRH Programme include UNAIDS and the African Development Bank
The AMRH Programme Team based in NEPAD Agency offices in South Africa serves as Secretariat to the AMRH Advisory Committee. NEPAD Agency as the designated technical body of the African Union, has the core mandate to facilitate and coordinate the implementation of regional and continental priority programmes and projects and to push for partnerships, resource mobilisation and research and knowledge management.
NEPAD Agency through the AMRH Programme also provides administrative, and planning support to the Partners including providing the secretariat for the AMRH Programme Advisory Committee.
The AMRH Programme is supporting RECs and their member state National Medicines Regulatory Authorities – in the development of regional medicines registration harmonisation project proposals as a first precursor to broader medicines regulatory harmonisation initiatives on the continent.
Proposal development has been unfolding as a three-stage process, consisting of:
- Data collection for the situation analysis on medicines regulation and harmonisation in the RECs and member states which informs the project proposal write up;
- Consultation and proposal writing workshops utilizing NMRA experts, industry representatives and RECs from the region followed by broader NMRA endorsement meetings, with representation from the RECs Secretariats and guidance from WHO, World Bank and NEPAD Agency.
- The proposals are then taken through the REC decision-making structures to secure Ministerial approval.
In this way, ownership by key stakeholder is assured and political commitment is strengthened hence significantly increasing the prospects for project success and sustainability.
Which RECs is the AMRH Programme currently partnering with?
The African Union officially recognizes eight RECs – ranging in size from five to more than twenty‐five member states – and all of which have been invited to participate in the AMRH Programme. In addition the Programme is actively engaging with other regional groups that are already active in the medicines regulatory harmonisation field. In instances where a particular country has membership to more than one REC, for the purpose of the AMRH Programme in order to avoid overlaps, duplication of resources and ensure consistencies across the RECs, the NEPAD Agency and the African Union Commission (AUC) undertook to propose with subsequent endorsement by the 5th Session of the Conference of Health Ministers (CAMH-5) held in Namibia from 20-21 April, 2011; the regional networks for implementation of AMRH as indicated hereunder:
1.1. EAC: Burundi, Kenya, Rwanda, Tanzania and Uganda
1.2. SADC/COMESA: Angola, Botswana, Lesotho, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, Zambia, Zimbabwe.
1.3. OCEAC/ECCAS: Cameroon, Central Africa Republic, Congo Brazzaville, Equatorial Guinea, Gabon, Tchad, Congo Democratic Republic, Angola, Sao Tome Principe.
1.4. ECOWAS-WAHO/UEMOA: Benin, Burkina Faso, Cape Verde, Cote d'Ivoire, Gambia, Ghana, Guinea, Guinea-Bissau, Liberia, Mali, Niger, Nigeria, Senegal, Sierra Leone, Togo.
1.5. CEN SAD/AMU: Algeria, Comoros, Egypt, Eritrea, Libya, Mauritania, Tunisia.
1.6. IGAD: Djibouti, Ethiopia, Somalia, Sudan.
For more information visi; http://www.amrh.org/participants/index.phpt [1]
