The African continent has attracted the global pharmaceutical industry’s attention due to its unique
profile: low access to quality healthcare, epidemiological transition, fast-growing population, a rising
middle class, and rapid economic growth. And the expanding middle class – with its ‘Westernized’
lifestyle – has a concomitant effect: an increase in non-communicable diseases (NCDs), like diabetes,
cardiovascular disease and cancer. This is also why the industry sees Africa’s commercial potential in
regard to new drugs for NCDs. ‘Of all emerging locations or regions, Africa has arguably the least access
to quality care, ensuring a steady stream of dedicated patients to fill trial enrollments’.3
The African Continent offers many of the best conditions for conducting clinical trials. Africa has adiverse
population of potential patients, and many have not been previously exposed to any kind of
pharmaceutical drugs. Importantly, a number of diseases- particularly those defined as neglected and
tropical are endemic to the developing world, which includes Africa.2
South Africa has been involved in International drug trials since the late 1970’s and with globalization,
the industry in South Africa has grown exponentially over the last few decades.1
South Africa is considered a clinical research “hot spot” due to its diverse genetic, drug naïve patient
population1. It is recognized for supplying high quality data across all phases of drug development at
affordable rates. South Africa has a sound infrastructure and huge potential.
Dr Soumya Swaminathan, Chief Scientist, World Health Organisation (WHO) stated at the AfricaBIO
symposium in June 2019, the need for the world to conduct research in areas that have unmet needs
and promote research in low income and middle income countries.
Regulatory environment in Africa for conducting clinical trials
GCP in South Africa is not only a guideline but a legal requirement, where informed consent is stipulated
in the bill of rights of the national constitution.4
SA-GCP is based on ICH-GCP and provides added protection for vulnerable populations.
South Africa has established regulatory agencies and Ministries of Health for eg South African Health
Products Regulatory Authority (SAHPRA) as well as established Research Ethics Committees.
A register of Clinical Trials through the South Africa National Clinical Trials Register (SANCTR) is
maintained.
The South African Medical Research Council (SAMRC) manages the Regional Pan African Clinical Trials
registry (PACTR) which collects details of trials across the continent and feeds information to the WHO
International Clinical Trials Registry Platform (ICTRP)
African Research Environment
Major Pharmaceutical companies have a presence in Africa. The trial sites have Multinational trial
experience ensuring familiarity with FDA requirements.
Governments are ambitious, research friendly and focused on developing health sectors of excellence.
Experienced sites, Researchers and facilities are available allowing capabilities in conducting Phase 1
through to large scale Phase III studies in both a public and a private trial setting.
Africa has high patient recruitment which is often faster than in the US and Western Europe
Seasonal reversal, with respect to the Northern Hemisphere, allows companies to shorten clinical trial
timelines.
Economic Environment and clinical trials in Africa
The impact of exchange rate differentials provides an additional economic benefit with clinical trial costs
being substantially lower than the US and Western Europe resulting in trials being conducted according
to international standards with a cost effective solution.
In South Africa, the section 11D Research and Development Incentive (R&D) was introduced into the
Income Tax Act, in 2006. Section 11D allows: A deduction equal to 150% of expenditure incurred directly
for Research & Development
Conducting Clinical Studies in the emerging markets of Africa is a benefit to both the pharmaceutical
industry, as well as to the populations of these countries.
References
- Burgess LJ, Sulzer NU. The Globalisation of Clinical Trials: Need for Capacity building and
training. South African Medical Journal, 2010 July - Patra SW, Tshwane University of Technology : Africa hosts very few clinical trials. Why this is bad
- Wemos Health Unlimited, Clinical Trials in Africa, The cases of Egypt, Kenya, Zimbabwe and
South Africa, 2017 July - Strugo V, Katsoulis L, Chikoto H, et al. Chapter 3 ; Clinical Trials in South Africa. In: Chim R, Bairu
M (editors). Global Clinical Trials: Effective Implementation and Management, Elsevier, 2011,
Pages 245-270