'Tumi', SA’s medicines regulator, is not scared to face the bullies in her field and follow the science

Dr Boitumelo Semete-Makokotlela. (Photo: SAHPRA)

By Sean Christie

12 Sep 2022

Boitumelo Semete-Makokotlela leads the country’s medicines regulator, the South African Health Products Regulatory Authority, a public entity few people knew about until the pandemic hit. Covid triggered a scramble for vaccines, tests and treatments that needed to be approved. Things often got bogged down in politics.

“Call me Tumi,” says Boitumelo Semete-Makototlela. This, after an awkward “do we shake hands nowadays or not?” in the doorway of her Centurion home. Unexpected winter rain had clogged up the roads and drawn out the school run, putting Tumi, casually dressed in a grey workout tracksuit, slightly behind schedule.

“I drop the two of them off at school myself every morning because it’s important to me that we use that time to connect,” she says, adjusting her stylish spectacles.

Semete-Makokotlela’s son (7) and daughter (11) have left half-packed bags in the den ahead of a week with their paternal grandparents. “I am going away with Khotso [her husband, a civil engineer]. If we didn't schedule time away together, we would quickly become strangers. Of course the kids are insisting we install Wi-Fi at gogo’s,” Semete-Makototlela laughs.

Their 43-year-old mother got the job of running the country’s medicine’s regulator, the South African Health Products Regulatory Authority (Sahpra), at a pivotal point: three months before Covid hit South Africa in 2020.

At the age of 39, considerably younger than many of her predecessors, the relatively obscure public entity Semete-Makokotlela was leading was 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 of her appointment, leaving the relatively young scientist with the task of not only reducing Sahpra’s approval processes from years to months, but also facing extreme political pressure from parties such as the Economic Freedom Fighters (EFF) to approve the use of jabs from countries such as 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 South Africa 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 “militant mass action” if Sahpra didn’t approve the Russian and Chinese jabs within seven days.

Semete-Makokotlela held the line. “I was worried about the safety of my children and husband, but I wasn’t scared. I was going to stand up against improper influences. 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 smooth 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 she’s too young? Aren’t you worried she’ll fail?”

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

Dr Boitumelo Semete-Makokotlela. (Photo: Sahpra)

Benjamin and Sheila Semete’s eldest child

Semete-Makokotlela was born in Soweto in 1979, the first child of Benjamin and Sheila Semete. She starts to say it was a typical upbringing, but catches herself and instead says: “Well, South Africa’s an interesting place … it was, even then.” Her parents lived and worked (mostly worked) with the single-minded purpose of buying a good education for their three children.

“To enable their work, I was sent to live 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.”

The phrase “joyful time” often precedes the telling of less happy times, and in Semete-Makokotlela’s case, the event that marked 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 this prim and proper school, we were given a hard time by kids from less privileged schools.”

Semete-Makokotlela’s response was to stay indoors and dream of leaving.

“The rejection of one’s circumstances can be such a powerful driver in life, and it can do that positively or negatively. I think my own life has been greatly shaped by a desire to escape.”

Political unrest in the late 1980s 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. Even now, when I go back, it is just to visit my…”

Her voice trails off, until with the resolve of someone who had contemplated not mentioning it, she says: “My father passed away a month ago yesterday.

“He was a good man. People, especially mom’s friends, keep saying that he was such a good father, a good husband.”

In her eulogy, Semete-Makokotlela said she is who she is because of the sacrifices her father made.

“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. Does work mean that much to you, that you can’t come, just today? But that is the man he was; so many big moments that 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.”

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A woman with ‘unparalleled focus’

From her father, Semete-Makokotlela learnt a work ethic that would serve her well at the University of Pretoria. The institution accepted her application to study biomedical technology, a choice inspired by “the most fantastic Standard 8 (Grade 10) biology teacher, who introduced the subject of genetics”.

But for this self-described “girl from Soweto”, Tuks was freedom – an almost disastrous dose, in fact.

“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 in Hatfield, too, and failed the first semester.”

Fearing her parents’ judgement, Tumi “pivoted”.

“I was, like, this is it … I’m going to create structure and I am going to learn to self-regulate, and I did.”

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

“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 that she learnt about uncompromising standards.

Tumi says: “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 North West 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, 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 that we are on 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.”

Semete-Makokotlela returned to South Africa in 2011 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-sized 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 learnt of the Sahpra opportunity from a pharmacist friend, she was initially 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, thinking, “I know I’m a person that gets things done … at least I can make a small difference.”

According to Professor Helen Rees, who chairs the Sahpra board, Tumi was appointed primarily because her vision of what she wanted to do “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.” DM/MC

This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.

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South Africa

Benjamin and Sheila Semete’s eldest child

A woman with ‘unparalleled focus’

‘Only a few have what it takes to lead’