In July 2011 the African Union Commission (AUC) and the United Nations Industrial Development Organization (UNIDO) agreed to a partnership for the accelerated implementation of the Pharmaceutical Manufacturing Plan for Africa (PMPA). The collaboration will be based on a number of guiding principles established at the stakeholder workshop held in June 2011 in N’Djamena. In September 2011 an extended workshop took place where AUC and UNIDO had detailed discussions to cap-ture the challenges that the pharmaceutical sector in Africa faces, to explore approaches that could be applied to facilitate the development of the industry, and to establish a program of work that will enable the partnership to build on this common understanding, consequently designing and implementing a strategy for the PMPA.
The PMPA was endorsed by AU Heads of State in Accra in 2007 and subsequently a technical committee was constituted to provide oversight to the implementation of the plan. Three technical committee meetings have taken place since then. Furthermore, the African Ministers of Industry at their conference in Algiers in March 2011 identified the pharmaceutical sector as being a priority for the continent and included it in the Accelerated Industrial Development of Africa Framework, acknowledging the PMPA as the mechanism by which the sector should be supported. As is described below it is recognized that developing the pharmaceutical sector has the potential to achieve both public health and economic development benefits but that to do this requires industrial development expertise and public health involvement.
Why develop the pharmaceutical sector in Africa?
Historically there has been a heated debate as to whether pharmaceutical production in Africa should be supported, with some commentators stating that the objectives of improved public health and development of the sector were mutually exclusive. However, this perception is increasingly being challenged and the AUC-UNIDO partnership is established firmly on the basis that public health benefits will be achieved through development of local production and that this can only happen through providing well conceived support to the local industry. There are a number of potential areas where local production of essential medicines can deliver pubic health benefits, for example through shortening supply chains and hence helping to reduce stock outs. Further, there is evidence to suggest that locally produced products are more widely available in rural areas than imported products.
Another key potential benefit is to develop a source of quality assured high quality affordable medicines across the range of products that are incorporated in countries’ essential drugs lists (EDLs). In recent years quality assurance for products to treat the pandemics has been conducted through the WHO pre-qualification scheme and/or the requirement for stringent regulatory authority approval for products procured by various international donors such as the Global Fund and the Presidents Emergency Plan for AIDS relief (PEPFAR). However, no such international quality assurance systems are in place for the many other products that are required for other indications including non-communicable diseases such as cardiovascular problems, diabetes and cancer. It is the responsibility of indi-vidual country medicines regulatory authorities (MRAs) to oversee the quality of products on the market, which given the severe resource restrictions is an impossible task as numerous plants based on different continents need to be inspected regularly. This limitation is one contributing factor that allows the scourge of substandard products to continue. Establishing GMP compliant manufacturing on the continent would enable regulators to assure the quality of products coming from these plants with regular inspections and this would provide for a quality assured source of products for the broad range of diseases that need to be addressed.
Most countries in Africa rely heavily on imports for pharmaceu-tical products whether it is for the pandemic diseases (as well as others), or for the overall range of products in countries less affected by the pandemics. This situation which has economic implications regarding use of hard currency, is for some a missed opportunity in terms of economic development and job and wealth creation, and poses a threat for the sustainability of treatment programs as and when donor fatigue sets in. Therefore, strengthening and growing the industry on the continent is of strategic importance for a number of reasons including long term health objectives.