Aspen Pharmacare has urged SA’s medicines regulator to support local firms by fast-tracking their applications to register new products, with head of strategic trade Stavrous Nicolaou saying it would encourage new investors, and keep existing investors happy.
The SA Health Products Regulatory Authority (SAHPRA) has previously prioritised the review of new vaccines and treatments required in a public health emergency (like Covid-19) and for HIV medicines.
Business Day reports that Aspen now wants it to use similar measures to help local drug firms get their products to market faster.
“We are not the only country that wants to produce locally – having a regulator aligned to this, with speed in the execution (of registration) is important to keep ahead of the pack,” Nicolaou told Business Day after speaking at the recent Africa Health ExCon conference in Egypt.
The conference is aimed at bolstering trade between African countries.
There is growing momentum among African nations to develop their local pharmaceutical manufacturing industries and reduce reliance on imports in the wake of the pandemic, which saw the region last in line when vaccines were in short supply.
At that stage Africa was producing barely 1% of the vaccines required by the continent and had no capacity to make its own jabs. Africa still imports almost all its vaccines, and less than 5% of the medicines used on the continent are made locally.
Key international agencies that procure vaccines, diagnostics and treatments for poorer countries have recently taken steps to support African pharmaceutical manufacturers.
In December, the global vaccine alliance Gavi announced a $1bn package to support African vaccine manufacturers, known as the African Vaccine Manufacturing Accelerator, the culmination of a campaign by the AU to reduce reliance on imports.
And the US President’s Emergency Plan For Aids Relief (Pepfar) is also taking steps to support African manufacturers of HIV tests, and plans to spend $20m on procuring 15m HIV tests made by African manufacturers in 2025.
Nicolaou urged the government to use its purchasing power to support local manufacturers and consider procurement from domestic suppliers.
“We have to see this as SA Incorporated: it does not matter which department is doing the procurement, it has to take the best decision for the economy,” he said. Procurement policies for pharmaceutical products are particularly sensitive, as there is inherent tension between the health department’s need to operate within its budget constraints and SA’s industrial policy.
In 2023, the health department took flak after snubbing local vaccine-maker Biovac in favour of India’s Cipla, which offered a lower price on shots designed to protect children against pneumococcal diseases.
While the decision saved the Health Department money, it conflicted with government policies to support domestic manufacturing capacity and improve its security of supply for both SA and the African continent.
It also forced Biovac to cut jobs.
Sahpra said it had initiated a process of developing a policy for supporting local manufacturers.
“This has been communicated to industry in various engagements with industry leaders. The industry is requested to enable SAHPRA to apply due diligence in developing the policy,” said spokesperson Madimetja Mashishi.
See more from MedicalBrief archives:
What SA should use as a bargaining chip for drugs trialled in this country
Cipla to produce anti-HIV injection in Benoni, Durban
Aspen contracted to produce insulin for Africa