Boitumelo Semete-Makokotlela’s children have nicknamed her “meeting”, because she spends so many evenings and weekends on virtual calls.
A biochemist by training, she was appointed CEO of SA’s medicines regulator barely two months before the coronavirus crisis hit SA. Taking the helm at the SA Health Products Regulatory Authority (Sahpra), which replaced the troubled Medicines Control Council (MCC) in 2018, would have been tough enough, but Covid-19 brought with it a host of new challenges.
“We were dealing with a complexity we had never had to handle before. At the same time, Sahpra had just come out of a strike and had all these operational gaps. People were still being transitioned from the Department of Health to Sahpra and some did not even know what they were supposed to do,” she says.
The health department hoped Sahpra would be the solution to the extensive delays at the MCC, which took far longer than other regulators to approve new medicines and clinical trials. But Sahpra has struggled to clear the backlog of 16,000 registration applications it inherited from the MCC, build internal capacity, and manage a far wider mandate than its predecessor that ranges from overseeing clinical trials and ensuring medicines are safe and effective to keeping tabs on diagnostics and devices.
It received qualified audits in 2018/2019 and 2019-20, still sits with a backlog of thousands of applications to register medicines, and is grappling with budget cuts imposed by Treasury as part of sweeping expenditure cuts throughout government over the medium term expenditure framework. It is in some ways caught between a rock and a hard place: it has filled only 290 of the 500 posts it needs to operate efficiently, and still relies heavily on external experts. Yet without skilled personnel it cannot speed up its scrutiny of registration applications and raise additional revenue from the fees it charges pharmaceutical companies.
“When we were hit by Covid-19, I was extremely worried. I thought we were not going to cope at all, as a lot of things were still manual,” says Semete-Makokotlela. Covid-19 forced Sahrpa to accelerate its plans to digitise its systems, it is still work in progress.
The backlog threatens to bog down new submissions, and clearing it will require a fundamental shift in the regulator’s approach, she says. Instead of evaluating every dossier in full, she wants to see staff apply a risk-based approach to determine which ones are assessed first and the level of scrutiny they require. Those changes will not be easy, but she remains confident most of the backlog can be cleared by the end of the financial year.
Covid-19 has catapulted Semete-Makokotlela into the public eye. She has come under immense pressure from lobbyists campaigning for access to the unproven drug ivermectin for Covid-19 patients, and taken flak for Sahpra’s decision to suspend use of Johnson & Johnson’s Covid-19 vaccine pending a safety review triggered by reports of a rare blood clotting disorder in US recipients. But that is to be expected, as any rigorous regulator will make decisions that are at times unpopular, she says.
“We need to be sure patient safety is paramount. One of the things I am hoping as a country we will begin to appreciate is the stringency of the regulator, and the benefit this has for the public,” she says.
Semete-Makokotlela was born in Soweto in 1979 to parents who prioritised the education of their three children above all else to ensure they all made it to university. Her father was a driver for a company that made butchery equipment, her mother a laboratory technician. “My mum had to resign from the National Health Laboratory Service at Baragwanath Hospital to access her pension so we could go to school. She went back to work but has a smaller pension than if she had not done that,” she says.
She credits her Northview High school biology teacher with sparking her interest in science, a passion that drove her to embark on an academic career that saw her obtain a BSc (honours) in genetics from the University of Pretoria and a PhD in biochemistry from North West University.
“There was family pressure, an expectation that now you have a PhD you must start earning — you know, the black tax,” she says. She nevertheless pursued postdoctoral research in targeted nanodrug delivery systems while working for the Council for Scientific and Industrial Research, where she ultimately headed its biosciences division. Along the way, she did a leadership fellowship at McKinsey and completed an MSc in management finance and investment at Wits.
She does not regard her lack of clinical or regulatory experience as a shortcoming. “I am not apologetic about the fact that I do not have the regulatory know-how, because I have access to people who do. As CEO you are not expected to be an expert. Your job is to ask questions, define problems, and help your team find solutions, and that is what I do.”
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