Stavros Nicolaou, Pharmisa chairman
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Pharmaceuticals Made in South Africa (Pharmisa), the industry association representing local pharmaceutical manufacturers, has heralded the policy position by South African Health Products Regulatory Authority (Sahpra) on enabling local manufacture as a significant development for local pharmaceutical manufacturing in the country.
Stavros Nicolaou, Pharmisa chairman said, “Pharmisa strongly welcomes Sahpra’s Policy Position and its commitment to growing regional pharmaceutical and vaccine manufacturing on the African continent. During Covid, we experienced what it was like to be at the back end of the pharmaceutical queue. Sahpra’s commitment through this Policy will assist South Africa and the African continent in ensuring security of supply of medicines and vaccines and is in line with the African Union’s commitment to procure 60% of pharmaceuticals and vaccines from African manufacturers by 2040."
He said despite various efforts to accelerate pharmaceutical industrialisation in South Africa, the various government preferential procurement levers have not been successfully implemented.
"Accordingly, we wish to commend Sahpra for this proactive step, which will not only assist localisation efforts but will also improve investor sentiment in the sector,” Nicolaou said.
The South African pharmaceutical industry operates in a highly contested and competitive environment, very often against peer countries that have a more competitive suite of industrial incentives.
He said this Policy will contribute towards making the South African pharmaceutical industrial offering more competitive.
"While priority review of registrations is an important step, we also call on government to accelerate the introduction of the public procurement regulations, in order that our country can begin to aggressively address the extensive trade deficit that exists in the pharmaceutical sector. Given our burden of disease, it has always been counterintuitive to run a trade deficit of this magnitude,” Nicolaou said.
This commitment by Sahpra is an important consideration for licensors and technology partners wishing to enter the South African market.
Furthermore, Pharmisa said this policy aligns with the recent Gavi AVMA (African Vaccines Manufacturers Accelerator) announcement, and it trusts it will contribute to an accelerated approval process with the World Health Organisation’s prequalification requirement. This is a pre-condition to the procurement of African-produced pharmaceuticals and vaccines by many of the multilateral procurement agencies such as Unicef, that procure for the African markets.
Two weeks ago, Unicef announced procurement targets for the African continent from African manufacturers and the Sahpra policy is an important enabler in achieving this, Pharmisa said.
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