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Can Sub-Saharan Africa produce its own drugs and medical equipment?

2020-12-16T01:13:34.694Z


The continent has 25% of the world's disease burden, but imports 94% of its medicines and produces less than 1% of vaccines globally. Increasing pharmaceutical production is urgent to guarantee health security. Covid-19 seems like an opportunity


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Africa has a problem.

The continent has 25% of the world's disease burden, but imports 94% of its medicines and produces less than 1% of vaccines globally.

At the start of the covid-19 pandemic, a hundred governments restricted exports of health products and the impact of global supply chains left the sector in countries like Nigeria operating at 40% of its capacity.

Then there is the issue of access to vaccines against the virus.

In the entire continent there is only one company, South African, in negotiations to produce any of the candidates.

Increasing local pharmaceutical production has emerged as a priority to ensure health security during and beyond COVID-19.

More information

  • Clash between the north and the south over the covid-19 patents

  • Goal: 2 billion vaccines against covid-19 for the whole world

  • What it costs to get a vaccine in a poor country

But can sub-Saharan Africa produce its own drugs and medical equipment?

And what does it take to move towards self-sufficiency, especially considering that in the coming years more and more African countries will stop receiving drugs and vaccines subsidized by international donors such as GAVI (the Global Alliance for Vaccines) and The Global Fund?

We have spoken with African producers and regional and international organizations about the opportunity that COVID-19 poses to strengthen local pharmaceutical production in Africa;

how to overcome the challenges faced by the sector in terms of quality and competitiveness, and what initiatives are being implemented to accompany the continent on its path to health security.

Small markets, conflicting policies

“If supply chains break down again or policies in producing countries change, who is going to die?

Well, people in dependent countries, ”says Janet Byaruhanga, Public Health Programs expert at the African Union development agency (AUDA NEPAD) based in South Africa.

"Will we continue to put our lives in the hands of other regions?" Asks this promoter of the AU Drug Manufacturing Plan in Africa, which since 2012 has affected aspects such as the harmonization of regulations.

In Africa, the market is fragmented, many countries lack effective regulatory authorities, and there is a mismatch between health, industry, trade, finance and intellectual property policies

According to an analysis by McKinsey, the continent has about 375 producers, mostly in northern countries like Egypt and Morocco, for a population of 1.3 billion people.

Producers in sub-Saharan Africa are often small and do not meet international quality standards.

By comparison, China and India, with about 1.4 billion inhabitants each, have about 5,000 and 10,500 drug producers and import around 5% and 20% of their medicines, respectively, the study says.

Their markets are larger and their prices lower.

In Africa, the market is fragmented, many countries lack effective regulatory authorities, and there is a mismatch between health, industry, trade, finance and intellectual property policies.

“Some countries say they want to increase local production, but their tariff policies favor the import of finished products,” explains US Pharmacopeia (USP) Vice President of Global Public Health Jude Nwokike.

The region is now pending the entry into force of the African Continental Free Trade Area, which seeks to create a single market, and the creation of an African Medicines Agency (AMA), a single regulatory authority along the lines of the EMA in Europe and FDA in the United States.

"Regulatory capacity is essential to ensure the quality of medicines and to attract investment," says UNAIDS Senior Advisor Ran Wei, whose organization has been advocating for antiretroviral production in Africa for years.

For now, the Agency has only been ratified by six countries, but another seven are needed for its creation.

The registration of products in each of the countries represents a source of income for the respective governments, which would be lost with the creation of a centralized institution.

The Advisor for Essential Medicines of the WHO Regional Office in Africa, Jean-Baptiste Nikiema, is confident that the Agency will achieve the necessary support from governments in 2021: “It is a fantastic project, the dream of a united Africa to develop its pharmaceutical industry, ”he says.

"Countries have to overcome their divergences to guarantee health security and covid-19 has opened our eyes in this regard," he says from Brazzaville, in the Republic of Congo.

WHO, he says, is helping governments understand the technical aspects of the Agency to promote its approval, in addition to supporting them on regulatory and quality issues at the national level.

Regulation matters because "accessing low-quality drugs is worse than no access at all," remarks Nwokike of USP, which in the last decade has supported dozens of regulators and producers in Africa to achieve international standards.

Counterfeit and substandard products for diagnosing and treating COVID-19, he says, are already circulating in the region.

To give an idea of ​​the magnitude of the problem, the UN Economic Commission for Africa (ECA) indicates that 70% of the medicines available to save the lives of young mothers are substandard.

Most local businesses have a difficult time accessing the lucrative market for vaccines and drugs financed by international donors.

"The challenge is not only cost, but also quality: there are not too many suppliers that have the products we need," says Lin Li, Head of Drug Supply at The Global Fund, the major global funder of the fight against AIDS. tuberculosis and malaria.

The cost of production tends to be higher because all, or almost all, the elements necessary for manufacturing are imported, from active ingredients to foam boxes for packaging.

Furthermore, companies often have little ability to negotiate prices and face obligations, rather than exemptions, from their own governments.

"These factors explain 40 to 50% of the added cost of [African] products relative to those of the competition," Li says.

The Global Fund has long sourced antiretrovirals and antimalarials from eligible African suppliers, although most of the products it funds are now produced in India.

"Covid-19 has highlighted the configuration of global supply chains and the dependence on certain regions," says Cathal Meere, an expert from the Global Fund, referring to the concentration of productive capacity in a few poles.

"We are looking to increase the supplier base and increase the robustness of our supply chains."

Strategic investment to reduce dependency

Improving the capacity and quality of pharmaceutical production requires financial and fiscal stimuli.

Infrastructures.

Reliable water and electricity supplies.

Qualified staff.

Good distribution systems and a strong industrial ecosystem.

USP's Nwokike underscores the importance of incentivizing the sector at various levels: “a government can facilitate access to local sources of raw materials, excipients and packaging materials;

then it can acquire or request the preferential acquisition of products manufactured in its territory ”.

Governments can also follow the example of Ethiopia, which gives a 25% price margin for local bidders.

"The pharmaceutical industry is a complex sector and developing it involves an investment in the medium and long term, but you have to start somewhere and somewhere," says Wei of UNAIDS.

The case of India and Bangladesh stands out, which were not countries with a high level of income when they made a commitment to the sector, and that of Ethiopia, which has adopted a national strategy and is creating an industrial estate to host production activities national and regional pharmaceutical company.

"For the countries, this is a strategic choice that requires investment, intersectoral coordination and alliances with the private sector," Wei summarizes, recalling that health and economic security go hand in hand.

The continent imports its pharmaceutical products from Europe (51.5%) and India (19.3%) and, to a lesser extent, from Switzerland (7.7%), China (5.2%), the USA (4, 3%) and the United Kingdom (3.3%)

Byaruhanga from AUDA NEPAD agrees that we must invest now to build a profitable and sustainable sector with economies of scale: “You have to make sacrifices;

at this time, reducing dependence on external producers such as India, China and the European Union is more important than accessing low prices ”.

For the AUDA NEPAD expert, it is not about acquiring less safe and effective products, but about betting on African companies that work with quality.

In his view, incentive packages also have to ensure that producing more locally translates into greater access to medicines for all Africans, unlike what happened at the time with India and AIDS medicines - the country became an exporter, although many Indians still do not have access to treatment.

Today, the continent imports its pharmaceutical products from Europe (51.5%) and India (19.3%) and, to a lesser extent, from Switzerland (7.7%), China (5.2%), the USA ( 4.3%) and the United Kingdom (3.3%), according to CEPA data.

Most of the active pharmaceutical ingredients used to make the medicines come from India.

For the director of Regional Integration and Trade of the organization, Stephen Karingi, “the covid-19 has shown that it is not sustainable to depend on foreign countries for the supply of pharmaceutical products and supplies;

for this reason, South Africa and Egypt have begun to produce active ingredients, a first step to improve the competitiveness of African products compared to those imported from Asia ”.

According to CEPA, South Africa, Egypt, Kenya and Morocco - in that order - export medical and pharmaceutical products with a total value of 100 million dollars and import them worth 5.800 million.

In many developing countries, vaccines and antibiotics can be imported duty-free, unlike ingredients required for local production.

As a result, local businesses are less competitive.

Companies that are growing

In addition to the aforementioned aspects, the experts place special emphasis on two main ways to accelerate local production and access to medicines.

One strategy consists of aggregating the demand from different countries so that the operation is economically feasible, both for manufacturers and for governments - above all, as long as there is no continental market and a single window to register pharmaceutical products on the continent.

A dozen East African countries, for example, have decided to add their demand for medicines for maternal and child health.

The initiative is part of a three-year pilot project led by CEPA in collaboration with the African Union, AUDA-NEPAD, WHO and UNAIDS.

According to Karingi, a joint acquisition worth $ 1.3 billion is expected to result in savings of 43% in all participating countries - Seychelles, Madagascar, Mauritius, Comoros, Rwanda, Djibouti, Eritrea and Sudan with the support of Kenya and Ethiopia, which are producing countries.

Another strategy is to promote cooperation between local producers, their governments, international pharmaceutical companies and investors.

"These alliances are the most efficient way to stimulate pharmaceutical production in Africa," says Christoph Spennemann, Head of Intellectual Property at the UN Conference for Trade and Development (UNCTAD).

One example is Cipla Quality Chemical Industries (CQCIL), a Ugandan-based company that supplies HIV / AIDS and malaria drugs to giants like The Global Fund and the US President's Malaria Initiative.

The executive director of CQCIL, Nevin Bradford, points out that the company has continued to operate normally despite the covid-19: it has exported to 12 countries on the continent, from Nigeria to Kenya via South Africa and Botswana, and has delivered one million HIV treatments to a southern African country facing a stock break.

"The supply of essential medicines in Africa can only be guaranteed by producing in Africa," says the manager.

The turning point for the company was eight years ago, when the Indian multinational Cipla became a majority shareholder, providing capital, technology and a portfolio of state-of-the-art products, as well as training local staff.

The company represents a trend joined by pharmaceutical companies such as the Kenyan Universal, which produces various essential medicines and also supplies international funders.

And as Bradford progresses, CQCIL is already planning to enter the field of noncommunicable diseases such as diabetes, cardiovascular problems and, in the longer term, oncology.

Market failures and vaccines against covid-19

African sector development expert Alistair West remarks that "we must think beyond HIV, tuberculosis and malaria, because there are other serious diseases as well", including communicable and non-communicable diseases.

Until very recently, it has promoted the implementation of the Drug Manufacturing Plan in Africa from the UN Organization for Industrial Development (UNIDO).

West believes it is vital to attract private capital through incentives and business opportunities, although he points to the risk for investors.

He cites the example of a Zimbabwean company that, in the past decade, achieved the WHO 'seal' of quality for an antiretroviral.

“Soon after, the drug was withdrawn from the market due to side effects;

this shows that companies may find themselves with a limited window of opportunity to obtain returns ”.

Hence the importance of policies to support the sector, says UNCTAD's Spennemann, especially in the face of market failures that make investment in such important products as vaccines and antibiotics unappealing.

"In the case of vaccines, the market discourages long-term investments because once the risk of a certain pandemic passes, the product is no longer profitable," he explains.

The same is true for antibiotics, which should only be sold by prescription, rather than in sufficient volumes to make the investment in research and development profitable;

an issue that UNCTAD is addressing in the framework of a new project with Ethiopia and the East African Community.

The South African Biovac, a government-owned company that produces 25 million doses a year for diseases such as measles, polio, tuberculosis, cervical cancer and influenza, attests to the diverse challenges.

It is the only African representative of the Network of Vaccine Producers of Developing Countries, which encompasses more than 40 manufacturers from around the world.

By the time the technology for the production of a vaccine has been transferred, which in some cases can take up to seven years, the market may have completely changed.

According to the executive director of Biovac, Morena Makhoana, the company is in negotiations with several international pharmaceutical companies for the production of some of the vaccine candidates against covid-19.

The plant could produce up to 30 million doses per year, which depending on the number of doses required - one or two - could cover between a quarter and a half of South Africa's population.

"We are confident that we will reach an agreement," says Makhoana.

"But to ensure sustainability, we must look at covid-19 with one eye turned towards the current pandemic and another turned towards routine immunization programs," he says, referring to the predictions that the virus will be incorporated into the usual vaccination schedule as it is the case of the flu.

In recent years, the company has collaborated with Pfizer and Sanofi to incorporate the latest technologies in production, and in the next five to ten years it seeks to enter new African and international markets.

Funding is going to large manufacturers, the usual ones, and there are hardly any initiatives to help emerging producers increase their capacity in the face of the next pandemics

However, Makhoana does not hide her frustration at the response of the international community to covid-19.

"Funding is going to large manufacturers, the usual ones, and there are hardly any initiatives to help emerging producers increase their capacity in the face of the next pandemics."

The executive also appeals to the role of African governments: “the Continental Free Trade Area, an African drug agency and the fact that countries leave behind GAVI subsidies could be opportunities for our sector, but only if governments choose buy from local pharmaceutical companies that meet quality requirements;

if policies don't change, it's hard to be optimistic. "

According to UNCTAD's Spennemann, there are several pharmaceutical companies that are considering transferring their vaccine packaging and finishing technology to Africa.

During the World Investment Forum in February, the expert plans to bring together vaccine producers, investors, owners of manufacturing technologies and African governments "to promote alliances that avoid a repetition of the current impasse", referring to the lack of productive capacity to respond to epidemics such as covid-19.

Countries such as Kenya, South Africa and Ghana could be candidates to host increased vaccine production.

The global mechanism for equitable access to vaccines for covid-19, known as COVAX, is working to ensure that these reach the countries with fewer resources, but Spennemann does not hide his concern.

“I am concerned about what will happen in the long term if the originators have 20-year patents without any conditions;

this would leave developing countries at their mercy, ”he says in reference to potential price increases in the future.

For Nikiema of the WHO, the path to health security in Africa must start with good governance, adequate regulations and transparency.

“In some places, [drug companies] have to pay to access the market;

this is unacceptable ”, he says in reference to the challenge of corruption.

Other priorities for the expert are, in this order, the creation of larger markets, access to loans with low interest rates and financial incentives.

The health sector in Africa can reach a value of $ 259 billion by 2030 and create 16 million jobs.

According to UNECA, the pharmaceutical subsector in Africa is one of the fastest growing in the world and is expected to reach a value of $ 60 billion by the end of this year.

The pharmaceutical sector is complex.

"But just because something is complex doesn't mean it's impossible," says Makhoana.

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Source: elparis

All news articles on 2020-12-16

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