Several United Nation agencies have raised concerns about the high underdevelopment of Africa’s pharmaceutical industry and the need to develop the local industry to tackle the high disease burden and the low public sector access to medication in the continent. The UN Economic Commission for Africa estimates that public sector access to medication is less than 60% and 70% of the continent’s total pharmaceutical products are imported.
It was pointed out that with Africa currently projected to be among the fastest growing pharmaceutical market in the world – predicted by McKinsey to be worth $40 billion to $65 billion by 2020, developing local pharmaceutical industry will not only enable the continent benefit from this market opportunity but will improve the health sector and the continent’s broader industrialisation plan, with direct impact on inclusive and sustainable development.
The African pharmaceutical sector is one sector that has been ignored by both local entrepreneurs and the government. Many African governments have relied on and waited for foreign investors and the “market” to inspire growth and development in the sector and have not been directly involved in a process of state-directed development.
Some African leaders have recognized that previous efforts to promote sustainable economic transformation in Africa have not yielded desired results, and have suggested that a new approach is necessary. The question becomes what is the best approach to providing inclusive and sustainable development in the pharmaceutical industry in Africa.
A Look at the Local Pharmaceutical Industry
The local pharmaceutical industry is both from a manufacturing and innovation point of view largely undeveloped. The little growth in the local sector is largely driven by the private sector, focused on manufacturing. Clinical research is mostly performed by international companies with local subsidiaries, and are hardly managed or performed by local as there is an extreme shortage of local expertise in drug development and regulation.
According to KPMG, apart from a handful of leading generic drug manufacturers that also develop drugs, such as Sanofi and GlaxoSmithKline, the industry is mostly composed of small companies, predominantly in North Africa and in South Africa, that serve their national markets. Interestingly, in 2011 Egypt, Algeria, Morocco, and South Africa accounted for more than half of the continent’s pharmaceutical sales.
The top indigenous pharmaceutical companies in the continent such as Saidal (Algeria), Aspen (South Africa), Starwin (Ghana) and Universal (Kenya) are focused on generic drug manufacturing. While this trend is increasing local production of generic drugs, without a committed effort by African governments to encourage the development of novel drug locally and at the same rate, the local industry will remain underdeveloped.
Capacity Development through Local Drug Research and Development
To holistically develop the local industry every local system and institution involved in the entire process of Drug Research and Development (R & D), preclinical and clinical trials, patenting and regulation, manufacturing up to marketing must be developed concurrently. African governments and development agency can do this by initiating projects to develop novel drugs.
By investing in drug development initiatives – especially from traditional medicine, capabilities of the institutions involved in the process, such as universities, R & D organizations, clinical trial organizations, regulatory agencies will be developed. This is because to carrying out drug research at international standards of quality in most part of Africa, adequate infrastructure, well-trained staff, as well as specialized ethics committees, and well-functioning regulatory authorities are required to first be in place.
This was observed in the development of the novel sickle-cell drug, Niprisan. The Nigerian government through its pharmaceutical research institute, NIPRD developed a drug for treating sickle-cell disease from traditional medicine. The project led to the development of a benefit-sharing agreements model to encourage increased knowledge sharing between traditional medical healers, regarded as the first of its type globally and adopted by both WIPO and WHO.
The researchers involved in the project were trained in the application of good laboratory practice principles such as the WHO Good Laboratory Practice which were essentially alien to African scientists at that time. Important industry skills such as standard operating procedures, clinical trial management, process technology, pilot scale-up, and pilot drug production were acquired. The project led to striking important partnerships and collaborations. Such collaboration with universities provided unique opportunities for on-the-job and postgraduate training.
The clinical trials of Fexinidazole – the first oral drug for sleeping sickness – in the Democratic Republic of Congo and the Central African Republic is another project that resulted in local capacity building. The clinical trials by the Drugs for Neglected Diseases initiative (DNDi), the not-for-profit research and development organization was carried out by a team of local scientists and health workers. The project which was conducted in nine hospitals in Congo and one in the Central African Republic led to the retrofitting of local hospitals, training more than 200 local personnel and installing satellite dishes to bring internet service to the test sites.
African governments should capitalize on the continent’s abundant indigenous medical knowledge and biodiversity and kick-start national drug development projects in partnership with the private sector, and international partners. They should set up national drug development systems in partnership with initiatives such as the African Network for Drugs and Diagnostics Innovation (ANDI), a pan African initiative with an objective to promote and support health product Research and Development led by African institutions for diseases of high prevalence in the continent. The expected outcome is the discovery, development, and delivery of affordable new health tools including those based on traditional medicine, as well as the development of capacity and establishment of centres of research excellence.