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DURBAN, South Africa — A top executive at Africa’s biggest drug company shared a few home truths with the continent’s health policymakers about the obstacles to local manufacturing at the Conference on Public Health in Africa (CPHIA) 2025.

Aspen Pharmacare’s Dr Stavros Nicolaou blamed regulatory bottlenecks and procurement policies for the failure of drug manufacturers on the continent to realise their potential.

“It is unacceptable for African manufacturers to undergo a six-year [qualification] process before you get to market. We can do this in half the time,” he told a conference plenary session on local manufacturing on Thursday.

He is both Aspen’s group senior executive for strategic trade and chair of the industry body, the Pharmaceutical Manufacturers in South Africa.

It is a myth that African manufacturers are uncompetitive, added Nicolaou. For example, Aspen is active in 55 markets, reaches patients in over 150 countries, and is the global leading supplier of generic anaesthetics outside of the US.

Shift procurement

Nicolaou called for a shift in multilateral procurement, including by Gavi, UNICEF and the Global Fund to Fight Aids, Tuberculosis and Malaria.

He told delegates that the establishment last year of the African Vaccine Manufacturing Accelerator (AVMA) was “a start”, but that the accelerator is “not fit for purpose” in its present form.

AVMA is a financing mechanism set up to raise $1.2 billion for manufacturers over 10 years. Nicolaou told Health Policy Watch that this amount  – earmarked for “fill-and-finish” drug manufacturers – was rather modest. 

He feels that there is insufficient incentive to spur the growth of the sector, upon which the future expansion of the medical products value chain depends.

“We can’t have African solutions compiled elsewhere and imposed on Africa. It won’t work.”

Pooled procurement of vaccines, therapeutics and diagnostics must be established “with speed”, he said.

‘Nothing has happened’

Nicolaou noted that more than four years had passed and “nothing” had happened since the African Union and the Africa Centres for Disease Control and Prevention (Africa CDC) announced their ambition to ensure the continent manufactures 60% of its vaccine needs by 2040. 

The AVMA launch came in the wake of the COVID-19 pandemic, which exposed the continent’s 99% reliance on foreign vaccine manufacturers and how its urgent needs were relegated to the back of the world procurement queue.

Nicolaou also responded to comments by South Africa’s Minister of Science, Technology and Innovation, Dr Blade Nzimande, who gave the session’s keynote address.

Nzimande called for efforts to “build sovereign capacity” in R&D, science and technology, including across the “whole health manufacturing value chain…  be it therapeutic, diagnostic or vaccines we need for our continent”.

He described as “historic” the 60% by 2040 plan to develop tools to secure the continent’s health. He sketched how the initiative sought to expand capacity, implement health standards, and harmonise regulations — all themes elaborated on by other speakers and panellists at the session.

Nzimande toasted the initiative with a glass of water while at the lectern, encouraging his audience to join with applause.

“Government has an important role to play by acquiring locally produced therapeutics, diagnostics and vaccines,” he said.

Serial importer

Nicolaou said he was disappointed that Africa had the highest disease burden yet remained a serial importer and “every year the trade deficit in pharmaceuticals grows”.

South Africa and Egypt have the continent’s largest pharmaceutical markets.

“If you’re talking about security of supply for the continent, South Africa is immensely important. Charity starts at home in that we need to fix our own [national] procurement legislation first,” he said.

“Most of the volumes are procured via the state, and yet we continue to be a serial importer of pharmaceutical products in South Africa. The market is valued at R70-billion (manufacturers’ exit price)… and our trade deficit is more than 50% or around R39-billion.”

There was big potential for local production, yet South Africa continued to import high-volume products like antiretrovirals and vaccines, putting the brakes on local manufacturing development.

“There’s a heavy weighting towards importers, and we now have the data,” he said, citing customs figures, including information on imports from India.

Import reliance

“It demonstrates the extent of the problem. So we import significant and vast sums of our antiretrovirals. We have the largest HIV population of any country in the world; 17% of the world’s HIV population; there are about eight million infected people; about 6.6 million on treatment; and yet we continue to import most of our antiretrovirals.”

These imports were growing every year and, apart from antiretrovirals, included other high-volume products such as vaccines, TB medicines, and insulins.

He said this was despite local companies often being price competitive or representing “best value”: an opportunity to grow the local economy through the multiplier effect.

He proposed a three-point plan to remedy matters. First, the introduction of a priority review and parallel submission to expedite the licensing of medicines. The review of drugs by the national regulator should happen at the same time as the World Health Organisation’s review, instead of sequentially, which can add two to three years of costly delays.

Second, increase Gavi subsidies for the local production of vaccines to stimulate the market.

Third, establish a pool for procurement for the entire continent — as was successfully done during COVID-19 — to unlock economies of scale.

Also addressing the plenary, Nhlanhla Msomi, president of AfricaBio, called for a compact with the manufacturing industry to localise innovation.

However, Nicolaou said that it was premature to expect expansion of the value chain.

It was first necessary to support African manufacturers with fill-and-finish products to allow them to develop capacity and grow volume.  In time, they could then invest in extending the value chain.

“Unless you start getting orders and you start succeeding in fill-and-finish first, companies are not going to backwardly integrate into drug [active] substance development,” he said.

Nicolaou said progress was not happening fast enough, and this was sapping momentum to achieve the “60% by 2040” aim.

“There’s a domestic issue to sort out, and then a continent,” he said.

Also at the plenary session, Dr Serge Blaise Emaleu, a global and public health and infectious diseases expert, said sustainable development could shift Africa from being an epicentre of disease to the centre of innovation.

Local manufacture was the “backbone of a sovereign health ecosystem”, but he cautioned that the commitment by African leaders to promote manufacture and invest in research “must be backed by financing” and that governance and leadership were required, and these things must be “moving in lockstep”.

Emaleu identified five interconnected pillars upon which Africa’s R&D self-reliance must be built: linking science to production; funding for research and development; investing in human resources; *building infrastructure and technology, and finally a regulatory framework to safeguard and sustain momentum.

Image Credits: Africa CDC, Rwanda Ministry of Health.