Delays in aligning Africa’s pharmaceutical standards with those of the World Health Organisation (WHO) are standing in the way of the continent’s $70bn (R1.25-trillion) ambition to become a fully fledged pharmaceuticals manufacturing hub, says Aspen senior executive Stavros Nicolaou.
Nicolaou, a member of the Brics business council and chair of Pharmaceuticals Made in South Africa (Pharmisa), told Business Times the delay was blocking African pharma companies from selling to organisations such as the Unicef and Global Volunteer Initiative (GVI).
These bodies cannot buy from Africa without prequalification alignment, which the WHO has been slow to finalise.
The fact that local regulators have not aligned with the WHO, as the WHO is taking a long time to do this, doesn’t help the continent
— Stavros Nicolaou
“If you sort out the WHO prequalification issue, then organisations such as Unicef and GVI can start procuring. The fact that local regulators have not aligned with the WHO, as the WHO is taking a long time to do this, doesn’t help the continent. Procurers are not going to buy unless the continent is aligned,” he said.
After the Covid-19 pandemic left African nations at the back of the queue for vaccines, African leaders stressed the importance of developing the continent’s pharmaceuticals sector, which could reach a value of $70bn by 2030, according to the World Bank’s International Finance Corporation.
Nicolaou said WHO representatives met with the South African Health Products Regulatory Authority (Sahpra) in October last year, but there still is no agreement on how to move forward.
“To sell a product like a vaccine, our ... regulator has to register our product first. That can take two years. Then, only, can you submit to WHO for prequalification, and they can take another two years. Before you even get started…already four years have elapsed. You’re doing the same registration, because the requirements from Sahpra are the same as the requirements from WHO.”
He applauded Sahpra for committing to cutting the registration time frame by half for locally produced new products, saying this would go a long way in retaining investment.
“We simply cannot afford, when the next pandemic hits, that the continent is, again, in the position that [as] in 2021, when we were in the back of the queue because we didn’t act with speed and diligence on the commitment that we are speaking about.”
The WHO had not responded to questions at the time of going to print.
Meanwhile, US life sciences research company Thermo Fisher said it planned to set up a training and research centre in South Africa with ambitions to train 800 people in five years.
Marcin Kouri, regional director for speciality diagnostics at Thermo Fisher, told Business Times that these graduates would feed into localisation activities in vaccine manufacturing and biopharmaceuticals.
“If you want to innovate today as a researcher and try your idea, where will you do it?” Kouri said.
“This centre will [allow you] to go and test your idea and then see if you can develop something, which means we could see, shortly, South African researchers developing new tests, new solutions that are relevant for South Africa and the African continent — and why not for the world?”
He said Thermo Fisher was in partnership with the University of Limpopo, the University of Venda and Sefako Makgatho Health Sciences University in developing the centre, which would help to keep local talent in the country.
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