LENIAS HWENDA: Prioritise Africa-produced medicines for African needs

The upcoming Belgian presidency of the Council of the EU meeting in Brussels, set for March 20, presents a pivotal discussion: encouraging international markets to procure medicines made in Africa for African consumers.

This dialogue aligns perfectly with the final stages of the Pandemic Agreement negotiations in Geneva, which set out to emphasise 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 World Health Organisation (WHO) pre-qualified. However, the continent’s regulatory maturity is often unfairly criticised as being inadequate and too risky for international mechanisms to buy medicines from domestic African manufacturers they oversee.

Paradoxically, the same global procurement mechanisms extensively favour India — a country that 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. The WHO has, however, certified India as a Maturity Level 3 regulator for vaccines, meaning it is a stable well-functioning regulatory environment for vaccines, with some aspects of its vaccine regulation, such as clinical trial capacity, operating at the more advanced Maturity Level 4.

Regardless, the bottom line is that despite India not having a stable and well-functioning regulatory environment for medicines, international mechanisms prefer to buy medicines from Indian manufacturers but not from African manufacturers, leaving African nations dependent on India for their medicines.

Suffice to say that African reliance on Indian pharmaceuticals introduces significant risks to Africa’s security of access to medicines, as was amply demonstrated the practice of vaccine nationalism, in which India and other nations banned exports of vaccines and other critical essential medications during the Covid-19 pandemic. 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 are documented to originate from India, presents another major health security threat of Africans. The WHO reports that such products (substandard or counterfeited) result in about 500,000 African deaths annually, with Africa bearing the brunt of the global substandard and counterfeit market, a staggering $200bn industry.

These challenges are exacerbated by the fact that Africa imports more than 90% of its medicinal needs, and 99% of its vaccines from Asia, inadvertently fuelling the substandard and counterfeit trade.

In addition to posing a grave threat to public health, this situation stymies the growth of Africa’s pharmaceutical sector. Domestic manufacturers lose about $10bn in market share to illicit trade annually. This economic haemorrhage significantly hampers the sector’s potential for growth, job creation and ensuring reliable access to medical products.

In contrast to the bleak picture that reflects more perception that reality, Africa is not devoid of robust regulatory environments. Countries such as Ghana, Nigeria, Tanzania, Egypt and SA have developed stable, well-functioning regulatory systems for medicines and vaccines.

This raises the question: 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 and the enormous threat it poses to the health security of Africans as well as that of the entire world requires a multifaceted 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 pharmaceutical industry.

Concurrently, African regulators should heighten vigilance against imports from India, bolstering awareness among consumers and supply chain operators to mitigate the influx and distribution of substandard and counterfeit products.

Crucially, international medicine markets need to shift their strategic purchasing priorities to include African manufacturers, and indeed prioritise them, particularly when buying medicines for the African market. This change would not only validate the capabilities of African pharmaceuticals but would also play a significant role in developing the continent’s pharmaceutical industry.

No country or continent can ever be entirely self-sufficient in producing all its medical product needs. However, the near total dependence on others for access such as that of Africa is harmful to 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 African manufacturers that meet required standards could start with prioritising manufacturers in countries that have mature, stable well-functioning regulatory systems, such as SA, Ghana, Egypt, Tanzania and Kenya, and with the support of the African Medicines Agency, expand to other African countries as regulatory capacity of more countries matures across the continent.

Africa’s potential in the pharmaceutical 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 that is more resilient during pandemic situations.

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.