Access to new life-saving drugs speeds up

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 five years or older, the oldest dating back to 1992.

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

Drug firms withdrew thousands of older applications for products no longer commercially viable, while Sahpra moved to get rid of duplicate applications and set 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 under-capacitated and underfunded, and is not where it needs to be,” said Stavros Nicolaou, chairperson of the Pharmaceutical Task Group (PTG), which represents SA’S key associations for drug manufacturers. PTG’S 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 of SA.

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

Cancer Alliance treatment advocate Salomé Meyer said Sahpra had prioritised registration applications for cancer medicines, but it still took 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.

The Cancer Alliance is an association of NPOS focused on improving cancer care.

Meyer said patients could access unregistered products imported from countries that had approved them using an exemption to the Medicines Act, but this mechanism was expensive and not widely used.