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Feature Generic Drugs

Can (and should) Africa make its own medicines?

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h2178 (Published 28 April 2015) Cite this as: BMJ 2015;350:h2178
  1. Mara Kardas-Nelson, freelance journalist, USA
  1. marajenn{at}gmail.com

Africa has a huge burden of disease but makes few of its own drugs. Mara Kardas-Nelson reports on the region’s nascent pharmaceutical industry and its chances of success

Support for Africa producing medicines is in vogue these days. The World Health Organization executive director, Margaret Chan, supports it.1 So does Michel Sidibé, head of UNAIDS. “The goal is to address health inequities and build capacity to meet supply shortages for essential health commodities that cannot be sourced reliably and sustainably from outside the continent,” they wrote last year.1 Major international organisations and donors, from the UN Industrial Development Organization (Unido)2 to the German Federal Enterprise for International Cooperation,3 are providing technical assistance to make local production happen, and the African Union has put together a business plan to spur its implementation.4

The rationale for local production is simple: it is assumed that big donors bankrolling many of Africa’s programmes for HIV, tuberculosis, and malaria, three of the continent’s biggest killers, won’t stick around forever. Africa imports 70% of its drugs,5 and if African countries have to pick up more of the tab, some drugs could instead be produced at home, bolstering local economies. Local production might also provide a more steady supply of medicines, ensuring that drugs are immediately available during local health emergencies and even in the face of international shocks, such as when the Chinese government closed down its chemical companies during the Beijing Olympics, leading to shortages of active pharmaceutical ingredients used by some African countries.6

Local production could also give greater control to overstretched African regulators, which are battling against low quality drugs, sometimes made in far-off factories that are difficult to monitor. African companies, governments, and international organisations that support local production say the aspiration is for Africa to be able to produce generic drugs, not patented products, spurring an industry like that of India’s, which has one of the largest generic industries in the world.7

But making enough medicine for the continent is a long way off. According to WHO, 37 sub-Saharan African countries have some pharmaceutical production capacity, but only South Africa makes active ingredients, the key component of a medicine.8 And even where pharmaceutical companies are up and running, output is limited—for example, WHO estimates that Ghana’s pharmaceutical sector, one of the healthier in the continent, is operating at only 50% capacity.8

Barriers

African companies face substantial hurdles. Supplies of electricity and water are often unreliable, and poor roads make transporting goods cheaply, and efficiently, difficult. Several people—from African drug manufacturers to representatives of international institutions—told me that it is cheaper and faster to transport goods from India to Kenya than from Mombasa to Nairobi (within Kenya).

Finding enough appropriately skilled staff is another problem. Many African countries produce only handfuls of pharmacists, technicians, and business managers each year, many of whom leave for greener pastures. And accessing affordable finance in some countries can be difficult. Take the case of Zimbabwe, where a once thriving pharmaceutical sector, already gutted by a series of economic and political embarrassments, was dealt a final death knell by the 2008 hyperinflation crisis. Alois Muchabaiwa, managing director of Zimbabwe’s Varichem Pharmaceuticals—in its heydays one of the region’s most successful companies—says that now the firm can’t get a loan for longer than 12 months.

Even if companies are successful in starting production, they face steep competition from Indian generics, which famously supply antiretrovirals at 99% below originator prices. Affordable generics from the country has helped to fuel a massive international response,9 and Indian generic producers continue to act as the key supplier of medicines to big donors like the Global Fund to Fight AIDS, Tuberculosis and Malaria and the US President’s Emergency Plan for AIDS Relief, whose multibillion dollar annual budgets fund the overwhelming majority of programmes for these three diseases in many African countries.10 Indeed, 80% of antiretrovirals purchased with donor funding in low and middle income countries are made by Indian manufacturers.11

Fledgling African producers, in need of large and predictable markets in order to reach economies of scale, want a slice of that pie. But most international funders require the medicines they buy to be either WHO prequalified or approved by a stringent regulatory authority like the US Food and Drug Administration or the European Medicines Agency. (No African regulatory authorities are considered stringent, and most African companies prefer to use the prequalified route.)

Tough market

Today, only a handful of African produced drugs are WHO prequalified. And prequalification doesn’t guarantee procurement from a big donor. “There’s an expectation that you get prequalified and then suddenly you’re the goose that gets the golden egg,” says Alastair West, senior technical adviser at Unido’s local production project. “But all the donors are supplying medicines for the same diseases, so the market is saturated. It’s very difficult to compete. There are very low margins.” Uganda’s Quality Chemicals, one of Africa’s flagship drug companies, has yet to supply antiretrovirals to any big donors despite getting WHO approval, largely because its prices are almost double that of the cheapest Indian generics.12

Some local production proponents accuse donors of choking the continent’s pharmaceutical industry. Wilberforce Wanyanga, a former Unido consultant and former general manager for Cosmos, a Kenyan drug company, says that when the Global Fund started supplying antimalarials in the country, it sourced primarily from companies outside the continent, pushing a healthy local industry out of the market. He says that before the Global Fund supported malaria programme was introduced 16 Kenyan companies were making artemisin based combination therapies. “Now there are only two, because the Global Fund is supplying everything.”

“You’re actually strangling a country. You need to have generic producers who can jump in when you have a shortfall of supply,” he says.

Sudip Chadhuri, professor of economics at the Indian Institute of Management in Kolkata, says the attitude of donors is, “We want to buy from the cheapest source. We don’t care about industrial policy.” The Global Fund’s head of communications, Seth Faison, agrees. “We see [local production] as a practical issue not a political issue. Wherever a company can produce high quality health products at reasonable prices, we are interested, no matter where the company is located … We strive to serve people, not companies, and not governments. We cannot compromise on quality and price.”

Local production has some important sceptics. For example, South Africa’s Treatment Action Campaign, which campaigns for better access to care for people with HIV, says that more expensive, locally produced medicines should not necessarily be favoured over affordable imports that have been key to fuelling the international response to the epidemic, especially given limited health budgets.13 Zafar Mirza, coordinator of the health systems and innovation cluster at WHO, says that whether African local production is a good thing “depends on your definition of success. Are you looking at this from a health perspective or an industrial policy perspective? You need to ask: which medicine is being produced? Is it aligned to local needs? Is it affordable? Is it of high quality? A company may be doing very good business producing only vitamins, or only cough and cold remedies, which are not good commodities from a public health point of view.”

Although local production champions say that homegrown efforts could provide “African solutions to African problems,” there’s little indication that private, profit driven companies in Africa are any more willing than companies elsewhere to make drugs for neglected tropical diseases such as sleeping sickness and guinea worm, which disproportionately affect the continent. “What my shareholders will look at is return on investment,” says Palu Dhanani, managing director of Universal Corporation, a Kenyan generics company. “What is the benefit for us developing a product for neglected diseases when there’s no market for it?”

Christophe Perrin, pharmaceutical coordinator of Médecins Sans Frontières’ access campaign, suggests that companies focus on non-communicable diseases rather than the oversaturated market for HIV, tuberculosis, and malaria drugs, in which they can’t compete. “African countries are struck by cancer, asthma, diabetes. There we see a huge opportunity for African manufacturers to be ready for the needs of African people. We know the volumes that are needed in Africa, and the gap in access is enormous.” As a result of the focus on communicable diseases and an unexpected rise in conditions such as diabetes and heart disease, researchers say the continent as facing a “neglected epidemic” of non-communicable disease.14

African governments could do more to nurture budding industries. Countries could set up regional medicine regulatory authorities, allowing companies to sell in multiple countries with only one registration, saving time and money and, importantly, offering expanded markets. Until that happens, individual regulatory agencies could be strengthened to stamp out low quality drugs and boost confidence in African regulators—not necessarily known for their stringent oversight—and by proxy African manufacturers.

Other policies could also be enacted: interest rates could be lowered. Import barriers, such as tariffs on imported medicines, could be levied. Countries could decide to buy selected medicines only from local producers, as has been done in Ghana and Nigeria. Mostly, though, Chadhuri says what’s needed is political will. “What is the main constraint of the development of local production in Africa?” he asks. “It’s not the size of the market. It’s the attitude of the government. Industries do not just develop. They need to be supported.”

Notes

Cite this as: BMJ 2014;349:h2178

Footnotes

  • Competing interests: I have read and understood BMJ policy on declaration of interests and have no relevant interests to declare.

  • Provenance and peer review: Commissioned; not externally peer reviewed.

References

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