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SAHPRA boss Semete-Makokotlela a leader with 'unparalleled focus'

Boitumelo Semete-Makokotlela leads the country’s medicines regulator, the SA Health Products Regulatory Authority, a public entity few people knew about until COVID: she has proved herself a force to be reckoned with, writes Sean Christie for Bhekisisa Centre of Health Journalism.

The 43-year-old mother of two got the job of running the SAPHRA just three months before the COVID-19 pandemic hit South Africa in 2020.

At the time, considerably younger than many of her predecessors, she was confronted with the relatively obscure public entity she was leading, being transformed – practically overnight – into a household name in the middle of a political maelstrom.

SARS-CoV-2, the rapidly-changing virus that causes COVID-19, triggered a noisy scramble for the approval of COVID tests, jabs and treatments within a year after her appointment, leaving the relatively young scientist with not only having to reduce SAHPRA’s approval processes from years to months, but also with facing political pressure from parties such as the EFF to approve the use of jabs from countries like China and Russia, whose products the EFF believed were deliberately being overlooked in exchange for shots from western countries.

No medicine or health product can be used in SA without the manufacturers of such goods submitting data for SAHPRA to review. SAHPRA then studies the information to see if it accurately reflects how effective (or not) the product is, and if it’s safe to use.

In June last year, EFF leader Julius Malema threatened Semete-Makokotlela with staging a sleepover at her house and with “militant mass action” if the regulatory body didn’t approve the Russian and Chinese jabs within seven days.

But Semete-Makokotlela did everything but crack. “I was worried about the safety of my children and husband, but I wasn’t scared. To me it was clear: we were going to make decisions based on science, and no movement or political party was going to change that.”

Although SAHPRA gave China’s Sinovac jab conditional emergency approval that July, it rejected Russia’s Sputnik V four months later because of a lack of safety data.

Semete-Makokotlela’s handling of things wasn’t unexpected.

According to her PhD supervisor, Antonel Olckers (Semete-Makokotlela received a doctorate in biochemistry from North-West University in 2005), “(With Tumi’s appointment) people were asking, don’t you think that she’s too young? Aren’t you worried she’ll fail?”

But Olckers just shook her head and responded: “Give this woman the tools and get out of her way.”

Born in Soweto in 1979, the first child of Benjamin and Sheila Semete, her parents lived and worked with the sole purpose of buying a good education for their three children.

“To enable their work, I lived with my aunt in Orlando, sleeping on the kitchen floor because the house was small and very full. I laugh about this all the time with my cousins, and we can laugh because it was a joyful time.”

Marking the end of her carefree childhood was a move to Zone 2, Diepkloof. “My mom wanted to move us to a better school, a Catholic school.”

She liked the school – “I loved what the nuns were about, the order and the cleanliness” – but Diepkloof not so much.

“The area was largely Tsonga-speaking but I didn’t speak Tsonga. And being from a prim and proper school we got a hard time from kids from less privileged schools.”

She says: “The rejection of one’s circumstances can be such a powerful driver in life – positively or negatively. I think my own life has been greatly shaped by a desire to escape.”

Political unrest in the late 80s led to repeated school shutdowns and stayaways, compelling Semete-Makokotlela’s parents to place their three children in suburban schools nearer central Johannesburg. Leaving for school at dawn and arriving home at dusk became the norm, and with her sports bag in hand and wearing her Northview High blazer, Tumi’s alienation intensified.

“Soweto is a very open and communal society, and the unsaid expectation is that you will socialise quite well, but I didn’t fit in.”

She pauses. “My father passed away a month ago yesterday. He was a good man. People keep saying this: that he was such a good father, a good husband.”

She is who she is because of the sacrifices her father made, she adds.

“I don’t have memories of going on holiday with my dad, because he chose to work. He missed my PhD graduation. I was shattered. But that is who he was; so many big moments he contributed to financially yet was never present for. It created a void, but you get over it because you realise that’s how he loves.”

A woman with ‘unparalleled focus’

From him, Semete-Makokotlela learned a work ethic that would serve her well at the University of Pretoria, where she applied to study biomedical technology, a choice inspired by “the most fantastic standard eight (grade 10) biology teacher, who introduced the subject of genetics”.

But for this “girl from Soweto” Tuks was freedom, an almost disastrous dose. “I loved the diversity of the place and the fact that I was side by side with the (prestigious) St Mary’s girls I’d envied from a distance at high school. I loved partying, too, and failed the first semester.”

Fearing her parents’ judgment, Semete-Makokotlela “pivoted”. “I was like, I’m going to create structure, learn to self-regulate, and I did.”

Semete-Makokotlela’s focus is legend among those who know her. “Unparalleled,” is how Olckers describes it. The mention of her masters and doctoral thesis supervisor elicits a grin from Semete-Makokotlela.

“Wooh, that woman! She made us work, hey. When you submitted a thesis chapter you just knew it was coming back with red marks all over, to the point where, today, I use a blue pen when critiquing students’ work!”

If her father’s example taught her about hard work, it was in Olckers’ lab where she learned about uncompromising standards.

“Sometimes we would sleep in the lab, rush home in the morning to shower, and come back; whatever it took to avoid disappointing Antonel. She was very firm, but you knew it was well intended, she really wanted all of us to succeed. And we have.”

Olckers has a photo from Tumi’s graduation ceremony, where she stands alongside fellow students Marco Alessandrini, now the chief technical officer of a biosciences company in Switzerland, and (now Professor) Wayne Towers, who chairs the ethics committee at Northwest University.

“They were an exceptional class, come to think of it,” says Olckers, who demands three things of her students – that they write a paper, present at a conference, and, if at all possible, work overseas, “because a doctorate isn’t a Nobel prize, it doesn’t set you up for life. As a scientist you compete internationally, it’s not enough to be the best in South Africa”.

‘Only a few have what it takes to lead’

After receiving her doctoral degree in biochemistry from North-West University, Semete-Makokotlela joined the Council for Scientific and Industrial Research (CSIR) as a researcher and then took up a postdoctoral research fellowship with the Swiss Federal Institute of Technology in Lausanne.

She recalls: “Man, it was a massive confidence boost for me to realise we are on a par in South Africa. The equipment was the same, they just had more of it, and from a knowledge perspective I found I knew the same things, and some things I knew better.”

The sometimes reclusive scientist also came to a new appreciation of her home country’s social warmth.

“Switzerland, for all its virtues, is a terribly lonely place – people keep to themselves. I missed being in a taxi, with people chatting away.” She returned to South Africa in 2007 mindful of something Olckers used to repeat: that most students will always be followers, only a few have what it takes to lead.

“I have never felt that I am innately a leader,” she says, explaining that her confidence in this regard, built gradually “with tenure”.

“I am an introspective person, and as I gained in experience I realised I do bring a few things to an organisation, like an ability to articulate clearly what I want to get done in the current moment, and to then follow through and get things done.”

A two-year stint as a McKinsey Leadership Fellow exposed Semete-Makokotlela to the world of management consulting, where she witnessed first-hand how biotechnology businesses operate. This, as much as her experience as a researcher, caught the attention of Mclean Sibanda, who recruited Tumi to lead a biotechnology incubator within a Gauteng provincial government project called The Innovation Hub. Here, she helped small and medium businesses with the commercialisation of their biotech innovations.

Sibanda found Tumi to be “teachable, a great listener, but also someone with strong ideas – all good traits for any leader in a fast-moving industry”. He wasn’t surprised to learn, after two years, that the CSIR wanted Tumi back, this time in an executive role as the head of the biosciences department. In many ways it was a foreshadowing of the scrutiny Tumi would come under at SAHPRA.

When Tumi learned of the SAHPRA opportunity from a pharmacist friend, she was sceptical. “I had never seen myself in a regulatory space, but the more I thought about it, the more I realised I understand something of the role and workings of the national health products regulator, and I care about its proper functioning.

She applied for the job.

Helen Rees, who chairs the SAHPRA board, said Tumi was appointed primarily because her vision of what she wanted to do, and because she “was so clearly and powerfully articulated”.

Semete-Makokotlela knew she needed “to get myself a good team” – and she did. But, she says, “they probably didn’t like me much the first two years. I mean, we didn’t sleep, we worked over weekends, we worked at night.”

And it’s that type of determination, Rees says, that Tumi uses to pull through difficult times.

“You might not know this but she’s a serious triathlete, as is her husband. When she gets home she doesn’t sit on the couch, she’s talking to you from her bike. If her phone’s off, she’s probably swimming across some or other dam.”

 

Bhekisisa article – ‘Call me Tumi’: Meet the young woman who heads SA’s medicines regulator (Creative Commons Licence)

 

See more from MedicalBrief archives:

 

SAPHRA gives a thumbs-down to Sputnik V vaccine over HIV fears

 

SAHPRA: Russian and Chinese vaccine authorisations a rigorous process

 

SAHPRA: Vaccine procurement not exclusive right of the state

 

‘Extreme concern’ over EFF threats against SAHPRA

 

SAHPRA appeals for a bigger budget to fill key vacancies

 

 

 

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