Patients get better access to life-saving drugs

SA’s medicines regulator has finally cleared its backlog of applications for registering new products, more than a year after its initial target of August 2021.

While the achievement boosts industry confidence in the authority and has improved patients’ access to medicines, critics say the SA Health Products Regulatory Authority (Sahpra) still takes too long to register new and potentially lifesaving medicines.

Sahpra inherited a backlog of more than 16,000 registration applications when it was formed from the Medicines Control Council in 2018. The backlog included applications for new chemical entities, generic copies of older drugs no longer protected by patents and requests to make changes to formulations or suppliers of active pharmaceutical ingredients.

Half the applications were more than five years old and the oldest dated back to 1992.

Backed by funding from the Treasury and external donors, Sahpra worked with the industry to reduce the backlog and redesign its processes.

Pharmaceutical companies withdrew thousands of older applications because the products were no longer commercially viable or because the market was saturated with similar products, while Sahpra moved to get rid of duplicate applications and put systems in place so it could use the decisions made by stringent regulators such as the US Food and Drug Administration to speed up scrutiny of the dossiers it received from pharmaceutical companies.

“There has been an improvement, but Sahpra is undercapacitated and underfunded, and is not where it needs to be,” said Stavros Nicolaou, chair of the Pharmaceutical Task Group, which represents key associations for drug manufacturers. Its members represent 80% of the SA market and include the Innovative Pharmaceutical Association SA, Generic and Biosimilar Medicines of Southern Africa, Pharmaceuticals Made in SA, and the Self-Care Association.

Before Sahpra began tackling the backlog, it took between five and seven years to register new chemical entities, and three to four years to register generic medicines, Nicolaou said.

The backlog project reduced the turnaround time to about 18 months, but Sahpra is still slower than many other stringent regulators, he said.

Cancer Alliance treatment advocate Salomé Meyer said Sahpra has prioritised registration applications for cancer medicines, but it still takes far too long to approve new drugs.

“It is all good and well to say that the backlog has been cleared. It remains, however, unacceptable that it takes Sahpra more than two years to approve a molecule that is in fact lifesaving,” she said.

Sahpra spokesperson Yuven Gounden said the regulator aims to register new chemical entities within 490 working days and generic medicines within 250 working days, but is constrained by its limited capacity.

“We just do not have the adequate capacity at the right skill level to assess the number of applications we receive.”