Africa’s reliance on Indian pharmaceuticals poses a risk to the continent’s security of access to medicine, and this week’s Belgian presidency of the Council of the EU meeting in Brussels presented a pivotal discussion: encouraging international markets to procure medicines made in Africa for African consumers.
Lenias Hwenda, writing in BusinessLIVE, says this dialogue aligns with the final stages of the Pandemic Agreement negotiations in Geneva, aimed at emphasising the critical opportunity to strengthen global health security by integrating African pharmaceuticals and vaccines manufacturing into the global value chain.
Despite prevalent misconceptions, Africa houses capable manufacturers meeting international standards, some of which are WHO pre-qualified. However, the continent’s regulatory maturity is often unfairly criticised as inadequate and too risky for international mechanisms to buy medicines from African manufacturers they oversee.
Paradoxically, the same global procurement mechanisms extensively favour India – which does not have a stable, well-functioning and mature regulatory environment for medicines in line with the WHO global benchmarking that evaluates the regulatory effectiveness of countries.
Yet the WHO has, however, certified India as a Maturity Level 3 regulator for vaccines, with some aspects of its vaccine regulation, like clinical trial capacity, operating at the more advanced Maturity Level 4.
The bottom line is that international mechanisms prefer buying medicines from Indian rather than African manufacturers.
Suffice to say the continent’s reliance introduces significant risks to Africa’s security of access to medicines – demonstrated by vaccine nationalism when India and other nations banned exports of vaccines and other critical essential medications during Covid-19.
This undermined multiple disease management programmes of African nations, setting them back decades, including for HIV/Aids.
The widespread circulation of substandard and counterfeit medical products, a significant proportion of which originates from India, presents another health security threat for Africans.
The WHO reports that such products (substandard or counterfeited) result in about 500 000 African deaths annually, with this continent bearing the brunt of the global substandard and counterfeit market, a staggering $200bn industry.
These challenges are exacerbated by Africa importing more than 90% of its medicinal needs, and 99% of its vaccines from Asia – fuelling this trade.
Apart from the threat to public health, the situation stymies the growth of Africa’s pharmaceutical sector. Domestic manufacturers lose about $10bn in market share to illicit trade annually.
In contrast to the bleak picture that reflects more perception that reality, Africa is not devoid of robust regulatory environments. Countries like Ghana, Nigeria, Tanzania, Egypt and SA have developed stable, well-functioning regulatory systems for medicines and vaccines.
So why do international procurement mechanisms for medicines overlook African manufacturers in these markets, despite their evident capacity and the strategic importance of diversifying global manufacturing operations for enhanced pandemic preparedness?
Addressing this oversight requires a multi-faceted approach.
Indian regulators must intensify efforts to regulate medicines exports destined for Africa, clamping down on the export of substandard and counterfeit medicines and other unethical practices that tarnish the legitimate Indian industry.
And African regulators should heighten vigilance against Indian imports, bolstering awareness among consumers and supply chain operators about substandard and counterfeit products.
Crucially, international medicine markets must shift their strategic purchasing priorities to include and prioritise African manufacturers, particularly when buying medicines for the African market. This would not only validate the capabilities of African pharmaceuticals but also play a significant role in developing the continent’s industry.
No country or continent can ever be entirely self-sufficient in producing all of its medical product needs. However, near total dependence on others for access harms health security domestically and internationally.
To be clear, this opinion piece is not advocating that medicines procurers should buy medicines from manufacturers that do not meet the requisite standards just because they are domestic African manufacturers.
African patients need safe, effective medications, no matter the source. Large scale international purchasing from local manufacturers that meet required standards could start with prioritising manufacturers in countries with mature, stable well-functioning regulatory systems – like SA, Ghana, Egypt, Tanzania and Kenya – and with support from the African Medicines Agency, expand to other African countries as regulatory capacity matures across the continent.
Africa’s potential in the sector is undeniable, with several countries hosting WHO-pre-qualified manufacturing facilities.
By making international purchases more inclusive by redirecting them towards these manufacturers, we can provide a stable reliable market for those businesses and promote industrial development within Africa that can make a valuable contribution to a more resilient global health infrastructure.
This strategy represents a win-win scenario, promoting sustainable economic growth within Africa while enhancing global health security in an era marked by pandemics and an increasing frequency of climate-driven health crises.
• Dr Hwenda is founder and CEO of Medicines for Africa.
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