Pharmaceutical manufacturers have voluntarily withdrawn thousands of applications to register new products with South Africa’s medicines regulator, as the SA Health Products Regulatory Authority (Sahpra) seeks to clear the huge backlog it inherited when it replaced the Medicines Control Council (MCC) last February. Local drug manufacturers are also lobbying the regulator to prioritise their products, arguing that this would boost investment in the sector and make domestic companies more attractive to potential international partners.
Business Day reports that at the end of 2018 Sahpra estimated that it faced a backlog of 16,000 medicinal product applications, some dating back to the early 1990s. The backlog includes 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.
Sahpra has worked with the industry and external consultants to tackle the backlog while redesigning its systems to make sure it never happens again, said board chair Helen Rees.
“We have to clear out the past and get it (Sahpra) fit for purpose. You can’t have a functioning regulator with a backlog of that size. There are really important medicines in there waiting to be registered,” Rees is quoted in the report as saying.
The pharmaceutical industry has since January withdrawn 3,000 applications to register new medical products launched before 2014, some so old that they were no longer commercially viable, leaving the regulator with 5,139 to scrutinise.
The Pharmaceutical Task Group (PTG), which represents South Africa’s key industry associations for drugmakers, said in the report that Sahpra had got off to a slow start but had made significant progress in the past four months. “It’s moving in the right direction but it still has a long way to go,” said PTG spokesperson Stavros Nicolaou. “What’s encouraging is the highlevel, regular meetings between Sahpra and the industry.”
Nicolaou said drugmakers had withdrawn applications because the drugs were no longer commercially viable or because the market was saturated with similar products. Some companies had decided to cut back their lists in order to speed up the approval of more important products, he said.
The report says Sahpra has yet to appoint a permanent CEO or find suitable accommodation. It began work in February 2018 in the dysfunctional Civitas building in Pretoria, which houses the national department of health and was the focus of protracted industrial action in 2018. Sahpra is operating out of temporary premises at the Council for Scientific and Industrial Research. “This has not been an easy period,” said Rees.
Sahpra aimed to clear the backlog by August 2021, she said. It had advertised the post of CEO twice without success and was now head-hunting for the position, said Rees.
The report says Sahpra has also embarked on a recruitment drive to fill about 100 positions, also for staff for its newly expanded responsibilities. These include oversight of the medical device and complementary medicines industry.
Local drug manufacturers are lobbying the regulator to prioritise their products, arguing that this would boost investment in the sector and make domestic companies more attractive to potential international partners. And, reports Business Day, they appear to have found a receptive ear in health minister Aaron Motsoaledi, who has written to 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,” Motsoaledi said in the letter.
Unlike tax breaks for local manufacturers, it would not cost the government anything if Sahpra were to prioritise locally made medicines, the PTG's Nicolaou said.
The report says Rees acknowledged receipt of the minister’s letter, but said that it had not yet been 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 is the fact that the legislation governing the 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, regardless of how many versions of the drug were already on the market, Rees is quoted in the report as saying.
The system had been clogged with applications for commoditised generics, which were unlikely to have any significant effect on prices, said Rees.
[link url="https://www.businesslive.co.za/bd/national/health/2019-05-27-drug-makers-withdraw-thousands-of-product-applications/"]Business Day report[/link]
[link url="https://www.businesslive.co.za/bd/national/health/2019-05-28-local-drugmakers-lobby-medicines-regulator-to-prioritise-their-goods/"]Business Day report[/link]