Medicines for Malaria Venture Joins African Manufacturing Initiative
Intermittent preventive treatment in Pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) is effective in preventing maternal death and reducing maternal malaria episodes.

The Medicines for Malaria Venture (MMV) and African Centers for Disease control signed a Memorandum of Understanding (MoU) on Thursday to providing technical support to African manufacturers of antimalarial drugs that would help bring their products up to WHO-approved standards – thus ensuring wider use of locally-produced drugs on the continent and beyond. 

The move by MMV is the latest development in a growing wave aimed at scaling-up medicines production in Africa in the wake of the COVID-19 outbreak. The COVID pandemic exposed Africa’s over-reliance on imported drugs, estimated to comprise between 70 and 90% of drugs consumed on the continent, lighting a fire under the movement to ensure the continent could guarantee its own medicines. 

Ensuring that African-made products meet WHO standards would also make them eligible for bulk procurement by large, donor driven institutions such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, which recently pledged to source more of its procurement in Africa as well.

“COVID really turned up the heat on a long-running political dialogue in Africa on this idea of not wanting to be caught out, as has happened so many times, as the last one on the train to get served with medicines’,” said George Jagoe, executive vice president of access and product management at MMV. “There’s been 15 years of discussion on the African pharmaceutical manufacturing plan, but it feels like the last two or three years reached the boiling point thanks to COVID.”

Efforts of the African CDC have so far focused on building vaccine capacity. Vaccines are the most high-profile medicine Africa was frozen out of during the pandemic, but the hit to global supply chains also broke many of the continent’s other medical supply systems, leaving many without recourse to treatments.

With the acute vulnerabilities built into Africa’s dependence on foreign-made medicines in sharp focus, governments and industries across the continent began work towards a bigger goal: broader self-sufficiency in the production of medicines that are overwhelmingly imported from Asia, Europe, or the Americas.  

“It became pretty obvious that no one wanted to stop at just vaccines,” Jagoe said.

Malaria is a natural next target for African manufacturing efforts 

Malaria, a disease where the biggest burden is in Africa, is a natural target for such efforts, said Jagoe in announcing the initiative, which would see MMV expertise used to support manufacturers on the continent meet WHO standards for good manufacturing practices.

“Malaria couldn’t be more crystallized to point out the absurdity of a continent utterly relying on others to take care of what is disproportionately an African problem,” Jagoe said. “I think that’s one reason it’s become such a flagship for the larger discussion around African autonomy because it galls African Leadership to be running into this wall over and over again.”

According to the 2021 World Malaria Report, Africa was home to 95% of all malaria cases and 96% of all deaths. About 80% of all malaria deaths in Africa are among children under 5 years and pregnant women. Yet at least 79% of antimalarials consumed on the continent are imported from India and China.

In August, a manufacturing facility supported by MMV and Unitaid became the first African manufacturer to receive prequalification from the World Health Organization for sulfadoxine-pyrimethamine, a life-saving medicine used for intermittent treatment of malaria in pregnancy. Today, of the 375 drug makers in Africa, only five are WHO prequalified, but the Kenya-based facility represented proof-of-concept.

“It shows it’s feasible, that the concept is not rocket science,” Jagoe said. “African companies can continue to grow their capacity to make medicines that meet WHO standards and can be part of the global supply chain.”

Across Africa, the development of national and continental manufacturing capacities for anti-malarials has become intrinsically linked to the question of sustainable planning for its public health systems and crisis preparedness. 

“It’s not just an industrial policy, and it’s not just national pride,” Jagoe said. “These are linked questions for national autonomy and national strategic planning for their public health needs.”

Free trade agreements critical for cost-competitiveness

Health volunteers pick up supplies during a seasonal malaria chemoprevention campaign in Nigeria.

The agreement between MMV and the African CDC also has a trade dimension. The agreement also includes an appeal to AU member states to implement free trade agreements to ease the flow of high-quality, African-manufactured medicines isn’t just about access: it’s a question of cost.

Currently, much of the world’s supply of antimalarials comes from India. China comes in a distant second, but maintains a manufacturing capacity in parallel to its central role in the global pharmaceutical supply chain, and its economies of scale make for cheap production costs.

“Both countries are incredibly cost competitive, and African manufacturers are just starting their engines in a very competitive race,” Jagoe said of India and China’s anti-malarial production. “If on top of that they are hampered by protective or prohibitive tariffs, it’s a double hazard.”

Cost-competitiveness will be important for African companies seeking not just to supply their regions or continent, but to become players on the global market. Global health advocates and organizations – especially in the access to medicines space – have long argued for tariff relief for medicinal products.

Potential benefits include better public health and health outcomes, in turn providing a boost to developing local economies, accelerating the development of private industry, and reducing dependence on foreign-made medicines.

“If you want to give a shot in the arm to African manufacturing, free trade agreements that will expedite and lower the burden of flow of products between and within regions would be a real enabler for these companies to take off even faster,” said Jagoe.

Quality assurance remains a priority, and its systems are evolving

Dispensing medicines on World Malaria Day in Kisumu Kenya.

The question of quality has long dogged medical manufacturing in Africa. A number of major pharmaceutical companies tried and failed to develop manufacturing hubs in the continent in the 1990s, Jagoe noted.  After that, the idea of focusing on African production was effectively shelved. 

At the time, companies cited prohibitive costs and an under-availability of a highly trained technical workforce as making the endeavour to produce at international standards simply too difficult. 

“That was really a majority belief hammered deep into the ground,” Jagoe said. “I heard this for almost a decade.”

Today, as African regulatory agencies and medical manufacturing industries mature, global systems for regulating quality assurance are adjusting to fit the simultaneous need to promote African supply independence, and minimizing the threat of substandard medicines, he said. For instance, a new African Medicines Agency is currently in the process of being created. It is hoped that the AMA can play a key role in both harmonise drug regulatory regimes across the continent, and also combatting fake medicine products.  

Substandard medication remains a serious problem across Africa. WHO estimates that between 72,000 and 169,000 children under five-years-old die as a result of inadequate pneumonia antibiotics every year, while bad antimalarials are estimated to lead to anywhere from 31,000 to 116,000 deaths in Sub-Saharan Africa annually. While the full extent of the problem is unknown, the WHO estimates 1 in 5 medicines on the continent are either substandard or falsified, making the African region home to the highest prevalence of inadequate medications in the world.

The lack of access to necessary medicines and vaccines creates a vacuum often filled by falsified and substandard medical products.

WHO pre-qualification programme – ensures good manufacturing practices for approved products

The World Health Organization’s pre-qualification programme, launched in 2001 under the motto ‘No poor drugs for poor people’, was the first internationally recognized form of approval for quality of medicines production.

Prior to the pre-qualification programme, the US’s Food and Drug Administration and the European Medicines agency were effectively the only sources of authority on this question. The WHO stepping in to undermine this monopoly on quality assurance helped open the door to the expansion of generics medicines production in developing country pharma hubs, including in China and India. 

“In those years and pre-qualification was this remarkable gateway that said, we the WHO will have de facto regulatory blessing so that you the donors can be reassured that a product meets the kind of standards you’d want for anyone in your own countries,” Jagoe said.

Since then WHO pre-qualification has extended its domain. Under a separate programme it also rates and grades national regulatory agencies on a 1 to 5 “maturity” scale. The higher the rating, the higher the WHO’s degree of confidence in the abilities of that medical authority to regulate its own medicines, and issue safety and quality approval for its domestic production facilities.

Under that WHO programme, African countries including Ghana, Nigeria, and Tanzania have already raised their WHO regulatory rating level, creating a benchmark for others to follow.  

“I think what’s going to come out of these maturity level designations is a greater degree of recognition that ensuring the quality standards of medicines can be devolved to national authorities in Africa, which is a really important advancement,” said Jagoe. “We don’t want to relax this standard of what’s quality medicine, but maybe be more open to who can determine that.”

Image Credits: Karel Prinsloo-Jhpiego , Karel Prinsloo/Jhpiego, Munira Ismail_MSH, United States Army , WHO.

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