- All > Medicine Information and Evidence for Policy > Medicines Policy
- All > Medicine Access and Rational Use > Supply Management
- Keywords > domestic production - essential medicines
- Keywords > industrial policy
- Keywords > local manufacture of pharmaceuticals
- Keywords > local pharmaceutical industry
- Keywords > local production - generic medicines
- Keywords > local production capacity
- Keywords > manufacturing capabilities
- Keywords > pharmaceutical industry
- Keywords > pharmaceutical manufacturing capability
- Keywords > pharmaceutical manufacturing system
(2012; 119 pages)
This Business Plan addresses a complex industry and covers a diverse range of contexts across our 54 member states. Strengthening our ability to produce high quality, affordable pharmaceuticals across all essential medicines will contribute to improved health outcomes and the realization of direct and indirect economic benefits. This is the vision of the Pharmaceutical Manufacturing Plan for Africa (PMPA) endorsed by our Heads of State and Government at the summit in Accra in 2007. This Business Plan outlines a recommended approach for achieving these aims. It is designed to benefit all our member states through contributing to improved access to affordable, safe and efficacious essential medicines. In Africa, we bear a disproportionate burden of disease with, for example, 75% of the world’s HIV/AIDS cases and 90% of the deaths due to malaria. Our people suffer more than most from tuberculosis and there are many other infectious diseases that cause substantial morbidity and mortality. The extreme impact of infectious diseases is largely felt in sub-Saharan Africa (SSA) as our countries in the North have disease profiles that are more closely related to those of industrialized countries, with cardiovascular disease, diabetes and cancer being public health priorities. Non-communicable diseases are also becoming increasingly prominent across the rest of the continent given the demographic changes that are taking place and they are predicted to overtake infectious diseases as the leading causes of death in Africa by 2030.
These forecasts reflect the changing lifestyles that are associated with economic prosperity, a future that is predicted for much of our continent over the coming years. The future will also likely see a reduction in the level of donations in support of our healthcare systems as the global financial crisis plays out. Therefore, it is imperative that we implement a plan for developing our industry so that we can ensure access to quality affordable medicines independent of donations. Furthermore, there is the need to improve the quality of products to which our people are exposed across the Essential Medicines List (EML) as evidence suggests that there is significant penetration of sub-standard and counterfeit products in our markets.
The 4th Conference of African Ministers of Health directed the African Union Commission (AUC) to develop a Business Plan for the operationalization of the PMPA, a directive that was further re-emphasised at the 5th meeting in Namibia in 2011. The AUC duly convened a stakeholders meeting in Chad to review terms of reference which have guided the development of this Plan. That meeting reconfirmed that the objectives of the Business Plan should be to develop a sustainable supply of affordable, quality essential medicines; to improve public health outcomes; and to contribute to industrial and economic growth.
This Business Plan is premised on the belief that industrial development of the pharmaceutical sector will contribute to improved public health outcomes, provided that the development of the industry is based on the principle that all manufacturers supplying pharmaceuticals to our people should ultimately meet international standards of production. However, it is also recognized that we need to be pragmatic and that change cannot happen overnight. In view of this, we propose a road map approach where the industry is both supported and required to reach international standards of production over a period of time. Furthermore, the impact of ‘sub-standard’ production will be mitigated through ensuring that critical products that would have serious public health consequences should they be of unsatisfactory quality are only manufactured by those of our companies that have reached certain requisite standards. The context in which pharmaceutical manufacturing takes place is determined by a number of actors who form the ‘pharmaceutical manufacturing system’. These entities include the manufacturers themselves, national medicines regulatory authorities (NMRAs), various government ministries, trade associations and an array of distribution channels. Other key players include institutions that develop the human capital for this knowledge intensive sector...