The National Department of Health (NDoH) has delayed the launch of the much-anticipated South African Health Products Regulatory Agency (SAHPRA).

According to CEO of Pharma Dynamics, Erik Roos, the delay is a blow to the pharma industry and could cost the pharmaceutical sector dearly.

“The introduction of new generic molecules has long been postponed by the overwhelmed Medicines Control Council (MCC), which has a backlog of between three and five years for registering generic medicines,” said Roos.

“By delaying the launch by several more months could cost a company significantly and also wastes precious time in a product’s life. Most importantly, the postponement continues to hamstring South Africa’s ability to provide affordable, generic medication to its people, which it can ill afford given the already poor state of the health sector,” continued Roos.

Generic medicines are up to 80% cheaper than brand name equivalents and are currently only used by 56% of the population. Therefore, the savings could be massive if more generics are brought to market.

According to Roos, the industry has long since raised concerns over the MCC’s limited capacity to deal with registrations and agrees that SAHPRA could make a huge difference in streamlining processes that will bring products to market much sooner, but urges the NDoH to avoid any further undue delays in the launch of the regulator as this undermines the industry’s ability to supply much needed medicines to patients.

“We hope that this initial delay is not foreboding of the organisation’s future performance and that going forward, government prioritises its launch to not only revitalise and restructure SA’s healthcare sector, but to ensure a healthier nation,” concluded Roos.

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