Local drug manufacturers are lobbying SA’s medicines regulator to prioritise their products, arguing that this would boost investment in the sector and make domestic firms more attractive to potential international partners.

The SA Health Products Regulatory Authority (Sahpra) faces a huge backlog of applications from pharmaceutical manufacturers hoping to register their products, and takes far longer than regulators such as the US Food and Drug Administration or the European Medicines Authority (EMA) to process applications.

Health minister's receptive ear 

Local manufacturers’ efforts appear to have found a receptive ear in health minister Aaron Motsoaledi, who has written to Sahpra’s chair Helen Rees, asking her to establish a structure between the national health department and Sahpra that will determine a list of priority medicines.

“I have in this regard also expressed my view that the list of prioritised medicines should also take into account locally produced medicines,” he said in the letter, a copy of which has been seen by Business Day.

“This is probably the most important development for the local pharmaceutical sector in the past decade,” said Stavros Nicolaou, chair of the trade association Pharmaceuticals Made in SA (Pharmisa), which represents local drug manufacturers.

“Over a two-year horizon, we expect more local companies to retain manufacturing capacity in SA, we could see increased investments in capex [capital expenditure] and capacity, and it should open the way for local partnerships with international players,” Nicolaou said.

Unlike tax breaks for local manufacturers, it would not cost the government anything if Sahpra were to prioritise locally made medicines, he said.

Pharmisa’s members, which include Aspen Pharmacare, Adcock Ingram, Sanofi and Sandoz, among others, represent about 32% of the R52bn local pharmaceutical market, according to Nicolaou.

Rees acknowledged receipt of the minister’s letter, but said it had yet to be discussed by Sahpra’s board. A meeting had been set up to discuss the issue, she said.

“The biggest priority for the board and executive is to really create a highly effective, efficient regulatory authority without backlogs. That will support [the] industry more than anything else,” she said.

Sahpra was already liaising with officials in the national health department to determine which medicines to prioritise for public health, as its enabling legislation was silent on the issue, said Rees.

Part of the reason for the backlog facing Sahpra was the fact that the legislation governing the Medicines Control Council (MCC), which Sahpra replaced in February 2018, contained provisions that compelled the MCC to grant priority status to all the drugs on the government’s Essential Medicines List (EML) regardless of how many versions of the drug were already on the market, she said.

The system had been clogged with applications for commoditised generics, which were unlikely to have any significant effect on prices, said Rees.