Pharmaceutical Manufacturing Policy Support
The overall manufacturing sector across Africa is widely considered to be the ideal industry to drive economic development in the continent, due to the labour-intensive, export focused nature of the industry. However, most African economies focus on rawcommodity exports, rather than more sophisticated products like pharmaceutical goods. The importance of a viable pharmaceutical manufacturing sector is growing as structural changes in the African economic landscape accelerate. Constraints to the development of the pharmaceutical manufacturing sector stem from several factors, including limited access to finance; limited availability of skilled human resources; inability to access the detailed know-how necessary to implement an upgrading programme or design a new plant; significant costs involved in the proper development of new products; policy incoherence; and underdeveloped supporting industries.
That said, the major factor hampering the production of pharmaceuticals to a quality-level on par with international standards is the lack of adequate regulatory oversight, given the stringent levels of quality that need to be achieved and enforced in the pharmaceutical industry in order to attain international standards. The lack of oversight has led to Sub-standard products, as well as counterfeit products reducing market share for domestic producers that actually produce quality pharmaceuticals. Regulatory oversight of the pharmaceutical manufacturing sector in different countries across SSA diverges greatly.
On the whole, however, the WHO estimates that the majority of regulatory agencies in Africa lack the basic functions necessary to adequately protect public health. Furthermore, policy incoherence across government ministries has hindered, rather than promoted, development of the pharmaceutical industries. Policy conformity is hindered by the considerable number of participants in the pharmaceutical manufacturing system, which includes the manufacturers themselves, national medicines regulatory authorities (NMRAs), government ministries, trade associations, and the logistical element. An additional key element pertains to the development of human capital, considering the knowledgeintensiveness of the sector. Consequently, policy coherence across all these different sectors and agencies is paramount to the development of a successful pharmaceutical manufacturing sector.
Policies aimed at regulating and developing the life sciences sector differ significantly across countries in SSA. However, governments in the region have increasingly started to acknowledge the importance of their role in formulating policies conducive toward promoting innovation and technological advancement in healthcare, pharmaceuticals and the life sciences sector in general. Regional and multilateral organisations have played an integral role in this regard. The African Union’s (AU) Science and Technology Consolidated Plan of Action, published back in 2006, aligned the science and technology programmes of the AU and NEPAD. According to NEPAD, the plan emphasised the development of an African system of research and technological innovation by establishing centres of excellence dedicated to specific R&D and capacity building programmes.
These networks are organised as consortia of country-level institutions that bring their intellectual, administrative, infrastructure and financial resources together. Another AU report, entitled ‘Science, Technology and Innovation for Public Health in Africa’, highlights the importance of innovation in healthcare and addresses the shortcomings of current policies in bridging the gap between healthcare and economic goals. The ‘Freedom to Innovate’ report presented to the African Panel on Modern.
Download our full report on Life Sciences in Africa with a focus on Sub-Saharan Africa.