Why clinical trials are rarely conducted in Sub-saharan Africa

 Out of 48 low-income countries and the least developed countries analysed by the foundation, 32 are in Africa.[Photo, courtesy]

Patients in low and middle-income countries (LMICs) are largely excluded from clinical trials by pharmaceutical companies, limiting their access to life-saving treatments and therapies. 

An Access to Medicine Foundation report reveals that pharmaceutical companies tend to conduct trials in countries where they plan to market their products, often neglecting sub-Saharan African countries. 

The pharmaceutical industry primarily offers post-trial access plans in high-income countries to ensure the availability of products after their launch.

 “Companies only plan to make their pipeline candidates available in six countries in scope on average (out of a total of 113). This means people in many LMICs will face delays in accessing the latest innovations once they reach the market,” said Jayasree Iyer, the Chief Executive Officer at Access to Medicine Foundation. 

Clinical trials are designed to give patients access to potentially lifesaving experimental medications.

 Analyzing clinical trials from various companies for 81 diseases that disproportionately affect people in low and middle-income countries, the report found that less than half (43pc) of these trials are conducted in those regions. 

Once a product proves successful in clinical trials, registration through a regulatory agency serves as a critical step for patients' access to quality-assured healthcare products. 

The report identified a gap in product registration in Africa, revealing that 43per cent of innovative products approved within the past five years have not been registered in any African countries.

 Out of 48 low-income countries and the least developed countries analysed by the foundation, 32 are in Africa.

Failure to research the population might limit the company's understanding of how different patients respond to new therapies.

 Claudia Martinez, head of research at the foundation said companies should complement their efforts with concrete actions to ensure equity.

 “Companies must prioritise patient reach or risk falling short in addressing health inequity. Our findings lay out a clear path for pharma companies to do this, emphasizing how they can embed equitable access within their business operations,” said Martínez. 

Therefore streamlining regulatory processes through the Africa Medicines Agency could help facilitate more clinical trials in African countries, where populations are currently underrepresented in clinical research.

 The researchers found that the capacity to conduct clinical trials is constrained in some LMICs because of the poor infrastructure and lack of adequate facilities and trained healthcare workers.

 A complex regulatory framework that leads to lengthy approval processes discouraging the companies was also considered a factor hindering clinical trials. 

The availability of research organizations in such incidences usually supports the pharmaceutical companies in conducting trials. 

Pharmaceuticals are therefore encouraged to work with partners to build local research capabilities and conduct clinical research to help discover suitable treatments for diseases that are endemic in neglected countries.

Despite the challenges, some pharmaceutical companies like Bayer, GSK, Novartis, and Sanofi are trying to conduct clinical trials through partnerships with organizations in low-income countries.

The trials are majorly focused on HIV, malaria, and neglected tropical diseases

However, other conditions that disproportionately affect people in LMICs like tuberculosis and respiratory infections still receive little attention.

Despite concerted efforts, the report revealed that local availability of medicines through voluntary licensing and technology transfer remains limited. 

Voluntary licensing is always viewed as a way in which pharmaceutical companies can improve long-term and sustainable access to healthcare products. 

“Only two new non-exclusive voluntary licensing agreements were issued during the period of analysis for the 2024 index with a third following later,” said Iyer noting the decrease in licensing activities. 

Concerted efforts are underway to ensure a continuous supply of medicines across Africa besides the usual donations and imports.

 In Kenya, various manufacturing industries have expressed interest in establishing local health product manufacturing in the country. 

For instance, Kenya and South Korea are working together to increase local vaccine manufacturing. 

The government has also established the Kenya BioVax Institute to increase local production of health products. 

In the latest development, a pharmaceutical company based in the United States, Toni Pharmaceuticals Holding Corporation has announced plans to partner with Kenya Medical Research Institute to develop and test a vaccine for Mpox. 

The project is estimated to cost Sh. 233 million as the company will sponsor the trial while KEMRI oversees the execution of the study.

 Additionally, the government has shown commitment to strengthening local pharmaceutical manufacturing capacity to reduce the cost of drugs and enhance the implementation of Universal Health coverage.