Sanofi has reaffirmed its commitment to South African healthcare with the appointment of two senior leaders and a renewed focus on supporting healthcare professionals, expanding local partnerships, and improving access to essential treatments in key areas such as vaccines, immunology, and rare diseases.
“This is a new chapter for Sanofi in South Africa,” says Jean-Baptiste Bregeon, Sanofi South Africa’s Country Lead and Head of Vaccines. “We are focused on making a real impact through practical support for healthcare professionals, expanding access to important medicines and vaccines, and strengthening our ties with partners across the system.”
Focused leadership
Bregeon brings over 20 years of international experience, with senior roles in commercial and clinical operations across the Middle East, North Africa, and Eurasia. As former General Manager for North Africa at Sanofi Vaccines, he led efforts to improve vaccine access and build local capacity. He has also advised Sanofi’s global leadership on operational strategy and commercial planning.
Bregeon will oversee Sanofi’s overall strategy in the country and lead its vaccine division, which remains a core part of the company’s healthcare offering.
Lenisha Maharaj, newly appointed Head of Pharma for South Africa, Namibia and Botswana, is a seasoned Pharmaceutical Executive with over 20 years’ experience in the pharmaceutical and healthcare sectors. At Sanofi, she will oversee growth across the general medicines and specialty care portfolios, supporting both primary and specialist care.
“Sanofi understands the realities that healthcare professionals face,” says Maharaj. “Our goal is to support them with the right tools, training, and access to innovative treatments so they can keep delivering high-quality care.”
Strengthening partnerships and access
A key part of Sanofi’s long-term strategy is to build strong, lasting partnerships. Its collaboration with Biovac, a local vaccine manufacturer, is a core example. This will help to boost domestic vaccine production capacity and reduce reliance on global supply chains. Such public-private partnerships support healthcare resilience as well as local economic and scientific development.
Beyond vaccines, Sanofi is investing in other areas that have a direct impact on healthcare professionals and the patients they serve:
Clinical trials in South Africa: Expanding its local clinical research footprint to increase representation of African patients in global trials and ensure that treatment decisions are informed by local data.
Access to innovative medicines: Working to bring advanced treatments in rare diseases and immunology to South Africa, along with patient support programmes and diagnostic assistance, to help doctors and patients navigate access challenges.
Medical education and digital engagement: Offering CPD-accredited education, clinical webinars, and digital tools to help healthcare professionals stay updated on the latest treatment protocols and deliver more streamlined care.
Policy engagement and system support: Actively involved in discussions with policymakers and funders to help shape health policies that improve medicine access and promote fair, sustainable healthcare.
Supporting healthcare professionals
Sanofi says it recognises the ongoing pressures facing South African healthcare workers, from dealing with supply shortages and reimbursement hurdles to managing the growing burden of chronic and complex diseases.
“We see our role as being part of the solution,” says Bregeon. “We are here to support healthcare professionals, not only by ensuring a reliable supply of medicines, but by providing the training, tools, and partnerships they need to do their jobs effectively.”
The company is also prioritising engagement with healthcare professionals through regular updates, field team support, and opportunities for joint problem-solving around system-level challenges.
Sanofi says it is committed to staying in close conversation with the healthcare community and building a more resilient, inclusive, and patient-focused system.
“We want to work with doctors, nurses, pharmacists, policymakers and funders to build something long-term,” Bregeon adds. “We believe that by working together, we can improve outcomes for patients and strengthen the foundation of healthcare in this country.”
Researchers analysed 1 million records from national health surveys in 38 African countries and found progress in childhood immunisation coverage – but many countries, including South Africa, may still fall short of global targets
Maps of childhood immunisation coverage in African countries at regional level for 2020.
In the last two decades, childhood immunisation coverage improved significantly across most African countries. However, at least 12 countries, including South Africa, are unlikely to achieve global targets for full immunisation by 2030, according to a new study published July 29th in the open-access journal PLOS Medicineby Phuong The Nguyen of Hitotsubashi University, Japan, and colleagues.
Vaccines are one of the most effective ways to protect children from deadly diseases, yet immunisation coverage is still suboptimal in many African countries. Monitoring and progress in childhood immunisations at the national and local level is essential for refining health programmes and achieving global targets in these countries.
In the new study, researchers used childhood immunisation data contained in approximately 1 million records from 104 nationally representative Demographic and Health Surveys (DHS) conducted in 38 African countries between 2000 and 2019. Using modelling techniques, they estimated immunisation coverage trends through 2030 and assessed disparities across geographic regions and between socioeconomic groups.
The data showed overall improvements in immunisation coverage between 2000 and 2019. It forecast that, if current trends continue, most countries are projected to meet or exceed targets for achieving 80% or 90% coverage of vaccines against tuberculosis, measles, polio, diphtheria, pertussis (whooping cough), and tetanus. However, 12 of 38 countries are not on track to meet full immunisation goals, including high-development nations like South Africa, Egypt, and Congo Brazzaville. The study also pinpointed significant socioeconomic inequalities in coverage, with gaps in coverage of up to 58% between wealth quintiles. While these disparities were present across all countries, most are projected to shrink by 2030 –except in Nigeria and Angola, where inequalities are expected to persist or grow.
“These achievements are likely the result of sustained progress driven by decades of national and sub-national initiatives along with international support aimed at prioritising immunisation,” the authors say. “However, progress towards full immunisation coverage remains slow in 12 African countries examined. In most African nations, challenges related to vaccine affordability, accessibility, and availability remain major obstacles, driven by weak primary healthcare systems and limited resources.”
The authors add, “This study shows that while childhood immunisation coverage has improved in Africa, progress is uneven. Many countries and regions remain off track to meet global targets by 2030.”
The authors conclude, “Conducting this study reinforced how critical reliable sub-national data is for identifying communities being left behind. We hope the findings will help inform more equitable and targeted immunisation strategies.”
As healthcare reform gains momentum in South Africa, value-based care is becoming a hot topic – but meaningful progress has yet to take hold. The biggest hurdle? How care is purchased. Despite clear signs of stagnation, most funders remain committed to the same failed approach and have yet to drive the change that is needed.
“It’s encouraging to see a move away from fee-for-service thinking and a growing focus on value-based care. But to turn that interest into action will require real system reform – starting with strategic approaches to purchasing care that support system reengineering,” says Lungile Kasapato, CEO of PPO Serve, a healthcare management company that has been implementing value-based care in South Africa for more than a decade.
At its core, value-based care flips the script on how private healthcare is purchased in South Africa. Instead of rewarding volume, it prioritises prevention, puts patients at the centre, and ties payment to measurable outcomes. This stands in stark contrast to the dominant fee-for-service model, where doctors and hospitals are incentivised to provide more services rather than focus on delivering effective care.
A leading example of value-based care in practice is The Value Care Team, operationally supported by PPO Serve. This GP-led multidisciplinary programme broadens access while keeping costs in check. Teams are paid a risk-adjusted global fee to provide holistic patient care, along with substantial incentives tied to improved outcomes. The result is a model that aligns payment with patient outcomes – not the volume of services delivered.
To put it simply, Kasapato explains; “With value-based care, you don’t pay for every kilometre run, you pay to cross the finish line. And that finish line means improved health outcomes, prevention, and system efficiency.” For patients, primary healthcare under The Value Care Team looks and feels completely different. With no scheme benefit limits to navigate, patients are supported by a dedicated care coordinator who guides them through decisions made by their nominated GP and allied professionals. Each clinical team member has a complete picture of the patient’s health, working collaboratively rather than competitively to share accountability for delivering better outcomes.
This new approach to delivering primary care in the private sector isn’t just an isolated test run – it’s being developed and refined in real time. “We’re not just talking about value-based care, we’re implementing it,” says Kasapato. “At PPO Serve, we partner with practices to navigate day-to-day challenges, while working with medical schemes to design payment models that enable strategic purchasing. The Value Care Team is proof that value-based contracting isn’t just possible – it’s already happening in South Africa’s healthcare system.”
For this approach to take root and scale, medical schemes and state funders must take the lead by creating the market incentives that encourage providers and hospitals to adopt new ways of working. The Competition Commission’s 2019 Health Market Inquiry warned that without bold reform, South Africa’s private healthcare sector could face collapse – a warning that remains just as relevant today. But there is still an opportunity to change course. By embracing a strategic purchasing role, funders can help drive the system-wide transformation that’s urgently needed.
The Value Care Team is already leading by example, with a presence across Gauteng and KwaZulu-Natal, as well as in Bloemfontein and Gqeberha. Recognised by the World Health Organisation and featured in international peer-reviewed research as a breakthrough case study in emerging markets, the programme is actively driving real change – improving care coordination, cutting waste, and reducing unnecessary hospital admissions. Even so, Kasapato points out, the journey is far from over; “There is still a lot to learn from and with others as we move from talking about value to actually implementing it.”
The Nelson Mandela-Fidel Castro medical training programme has been controversial from the start. It’s had high points, low points and many say it should have an end point.
Almost 30 years since the Cuba-SA doctors’ training programme was launched, it still divides opinion.
This year only Gauteng and North West interviewed candidates for the bursary programme that sends students from South Africa to be trained in the island country.
Critics say the dwindling interest shows the Nelson Mandela-Fidel Castro (NMFC) medical training programme has passed its sell-by date. But supporters remain committed to its ideals and some beneficiaries of the programme still think of it as the opportunity of a lifetime.
Between the differing views, what can be glimpsed is a chequered story of three decades of trying to transform South Africa’s healthcare system. The programme has its origins in the ANC’s political fraternity with Cuba and the laudable ideal of boosting doctors numbers in under-serviced rural areas. But it is also a tale of political inertia arguably blurring over time into a blind spot as conditions changed. In the background is the stranglehold of corruption and maladministration in the health sector, shrinking provincial health budgets, transformation of doctors’ training, and changing curricula.
One concern is that little is actually known about the programme’s impact. There is a lack of clear data on the costs and the numbers of doctors produced. Shockingly, for such a long-running programme, no comprehensive evaluation reports have been published, as far as Spotlight has been able to establish.
A comprehensive evaluation would weigh the benefits of the programme against its costs, compare it to other options for training medical doctors, and contextualise it within the current reality of very tight health budgets in provincial health departments – as it is, not all the doctors we are training are being employed.
Given this context, it is not surprising that the National Department of Health recommended a scaling back of the programme a decade ago. While most provinces have taken this advice, the Gauteng and North West health departments have instead pushed ahead with the programme.
Old histories and old allegiances
The agreement that put in place the NMFC medical training programme was signed in 1996, with the first cohort of students leaving for Cuba a year later in 1997. It was a mere two years into democracy and South Africa urgently needed to address gaps in the provision of healthcare. Under apartheid, services prioritised a white minority mostly in urban settings and healthcare had a strong slant towards hospital or tertiary care. There was a shortage of doctors and those with the least access to healthcare services were rural communities made up mostly of black South Africans.
Medical schools mostly had curricula designed for the status quo and there were few academic pathways for underprivileged students who had good marks at school but were not top achievers, leaving them overlooked for scholarships and bursaries.
So the new government looked to Cuba.
With its focus on primary healthcare, preventative medicine, and community-based training, the Cuban approach to healthcare ticked many of the boxes for the South African government then led by President Nelson Mandela.
Since the communist revolution in Cuba in 1959, it has provided free healthcare to all its citizens. While there remains some scepticism over data collection and interpretation, politicisation of medicine, and limited freedom to criticise the state, Cuba’s healthcare system is also widely lauded.
According to the Primary Health Care Performance Initiative, the country registers average life expectancy at 78 years (South Africa is at around 66), infant mortality dropped from 80 deaths per 1000 live births in 1950 to just 5 deaths per 1000 by 2013, and it has one of the world’s highest doctor to patient ratios. In 2021, it was at 9.429 physicians per 1000 people, according to World Bank Open Data. In the same year, South Africa tracked at 0.8 per 1000.
Since the 1960s, Cuba has established itself as a hub for training international fee-paying students and sending them back to their mostly lower-income countries as graduate doctors. One of its biggest universities, the Latin American School of Medicine, graduated over 30 000 students from 118 countries in the 21 years since it was established.
Another tick was Cuba’s staunch support for the ANC. SA History Online emphasises the depth of solidarity. It notes: “Cuba was a state in alliance with provisional governments and independent states in the African continent. Cuba’s military engagement in Angola kept the apartheid state in check, foiling its geopolitical strategies and forcing it to concede defeat at Cuito Cuanavale, and ultimately forcing both PW Botha and FW de Klerk to the negotiating table.”
Costs and benefits
The political and historical bonds sealed the doctors’ training deal. But from the start, the bursary programme, funded from provincial budgets, came under fire. The estimated costs over nearly three decades are massive, but details remain fuzzy.
Spotlight’s questions to the national health department were “answered” in one paragraph by department spokesperson Foster Mohale. “More than 4 000 [lower numbers are quoted by government in other instances] doctors have been produced through this medical programme since its inception. The programme is still relevant today and complements the local medical schools to produce more doctors. Qualified doctors have options of joining either public or private health sector,” he wrote.
But discrepancies have been showed up in government’s own figures. In November 2022, Haseena Ismail, the then DA member on the portfolio committee of health raised concerns about the quality of government data.
Minister of Health at the time, Dr Joe Phaahla, said the preparatory year, including a stipend, cost US$4400 per student, and each of the following five years cost US$7400 per student. But a separate table from the health department listed higher figures – US$8400 for the preparatory year and up to US$15900 per student by the fifth year. Added to this, the department listed annual costs of US$6472 per student for food, accommodation, and medical insurance. There were also expenses for two return flights over six years, plus the cost of 18 months of tuition and accommodation for clinical training at a South African medical school.
Phaahla said that as of November 2022, 3369 students had been recruited into the programme, and 2617 had graduated. However, he noted there was no information on what happened to these doctors or where they were employed. Each bursary student is required to work for the state for the same number of years for which they received funding.
South Africa has 11 medical schools, with the most recent addition of the North West University.
The programme also faced criticism over selection criteria for bursary candidates and for requiring two extra years of training compared to local medical programmes. Students spend one year learning Spanish, five years training in Cuba, and then return to South Africa for an additional 18 months of clinical training at a local medical school.
Controversies have dogged the programme over the years. In 2013, the Afrikaans newspaper Beeld reported that by 2009, only half of the students enrolled in the programme during its first 12 years had completed their studies.
In 2012, government ramped up the numbers of students it sent abroad. In 2018, this backfired when about 700 fifth-year students returned home only to find they could not be accommodated at any of the then 10 medical schools in the country.
It was around this time that the national health department issued recommendations for the provinces to phase out the programme.
Gauteng and North West
Despite all of the above, the Gauteng Department of Health continues to fund students – around 20 last year and an expected 40 this year.
Spotlight’s questions on this to the Gauteng health department went unanswered.
Compounding the administrative and planning blunders for returning students is the impact of deepening corruption and mismanagement in Gauteng’s health department. It has been under routine Special Investigations Unit scrutiny as well as coming under fire for service delivery issues such as the ongoing backlog of cancer patients lingering on treatment waiting lists. In March, the South Gauteng High Court in Johannesburg ruled that the Gauteng health department failed in its constitutional obligation to make oncology services available.
The situation in the North West is also bleak. Its health facilities are routinely facing medicine stock-outs and understaffing. Its health department is regularly struggling with accruals and paying suppliers on time.
Given all these challenges, it is puzzling that these two provinces in particular are so committed to sending students to Cuba, we understand at higher cost than for training doctors locally.
‘Better investments’
Professor Lionel Green-Thompson, now the dean of the faculty of health sciences at the University of Cape Town, was involved in managing returning students from the Cuba-SA programme between the mid-2000s and 2016. At the time, he was a medical educator and clinician at Wits University where he oversaw the 18-month clinical training of more than 30 returning students.
“Some of these students were among the best doctors that I’ve trained and I remain a stalwart supporter of the ideals of the programme. But at this point, there are better investments to be made, including directly funding university training programmes in South Africa,” he tells Spotlight.
“A programme that’s rooted in our nostalgic connection with Cuba and its role in our change as a country is now out of step with many of the healthcare settings and realities we face in South Africa,” says Green-Thompson.
He says a proper evaluation of the programme needs to be done.
There are also lessons to learn, he says, including a review of admissions programmes. How some students who enter a programme at 20% below the normally accepted marks, exit the programme as excellent doctors, he says offers clues to rethink how great doctors can be made.
Green-Thompson also suggests we need to ask why specialisation has become a measure of success for many doctors in South Africa, often at the expense of family medicine. This, he says, takes away from the impact doctors make at community healthcare level as expert generalists.
But changing the perspectives of healthcare professionals requires early and sustained exposure to working in community healthcare settings, says Professor Richard Cooke, head of the department of family medicine and primary care at Wits. Cooke is also director of the Wits NMFC Collaboration since 2018 and serves on the NMFC Ministerial Task Team.
“I’m not in support of further students being sent to Cuba for the undergraduate programme, because these students are not being trained in our clinical settings,” he says, speaking in his Wits capacity.
“The Cuban system is far more primary healthcare based than South Africa’s, but that doesn’t necessarily translate into these students ending in primary healthcare,” says Cooke.
And curricula at Wits is shifting, for instance, towards placing students at district hospitals for longer periods of time, rather than weeks-long rotations, he says.
“When students become part of the furniture at a hospital, they become better at facilitating, at critical thinking, problem solving, teamwork and collaboration,” Cooke says.
But making this kind of transformation in local training takes government funding and commitment. Students and doctors need to be attracted to the programme and need reasons to stay. But the money and resources to make this happen are simply not there – even as the Cuba training programme continues.
Cooke adds: “There hasn’t been definitive data on the NMFC programme. But even if the programme over 30 years has done well and met its targets, it’s not been cost efficient. What’s needed now is to leverage expertise and established partnership in different, more cost-effective ways like in research, health systems science and health science education.”
Up to three times more expensive?
Professor Shabir Madhi, dean of the faculty of health sciences at Wits, says the NMFC programme costs an estimated three times more than it costs to train a student in South Africa. This, he says, should be enough reason for a beleaguered health department like Gauteng’s to stop sending students to Cuba.
He also says: “Government is aware that it simply can’t absorb the number of medical graduates being produced.” Madhi says some trainee doctors are sitting at home while others trying to finish specialisations are being derailed.
Broadly, he pins the blame on the mismanagement of resources, including the department underspending R590 million on the National Tertiary Service Grant meant to subsidise specialised medical treatment at tertiary hospitals.
Madhi says universities have worked hard to close the gaps identified by the NMFC programme 30 years ago, but now student doctors are being let down by government not playing its role.
“Across the universities, there’s been a complete overhaul of the curriculum to be focused on primary healthcare. Students are also getting community exposure as early as first-year training,” he says.
He says that when it comes to admissions, the majority of students entering medical schools across the country are now Black South Africans, and additional changes have been made to the selection process. “We used to have a race quota, but in further revisions, we have introduced criteria that focuses on the socio-economic component, with 40% of the admissions coming from students in quintile 1, 2 and 3 schools [no-fee public schools],” he adds.
South Africa has 11 medical schools, with the most recent addition of the North West University – specifically focussed on rural health – and the University of Johannesburg in the pipeline to join the list. So the number of doctors being trained and graduating is increasing. Madhi estimates the total number being trained is above 900 per year for Gauteng alone.
The bottleneck of getting doctors into clinics and hospitals, he maintains, is not a shortage of doctors, but government’s inability to pay doctors’ salaries or to create functioning, well-resourced workplace environments.
‘You can’t put a price on that’
For Dr Sanele Madela, the ongoing challenges cannot detract from the goal to get doctors into communities – including through the NMFC programme. Today, he’s the health attaché at the Havana Mission for the NMFC training programme. Madela was also at one time a schoolboy with a dream of becoming a doctor.
Growing up in Dundee in KwaZulu-Natal, he remembers almost never seeing a doctor in his community. “Then when we did see a doctor, it was a white person or an Indian person and they never spoke our language – a nurse would have to translate,” says Madela who was part of the 2002 NMFC intake.
The six years abroad, he says, exposed him to very different reasons for becoming a doctor.
“When people finish medical school, they say thank God it’s over, but in Cuba people say thank God for the knowledge and information so they can give back to their country,” he says.
When Madela got back to South Africa, his journey eventually led him to work in Dundee district hospital. It was the same hospital where his mother had worked as a cleaner.
The NMFC programme, Madela says, still plays a vital role because of its objective to get more doctors into rural and township areas – “and you can’t put a price on that”, he adds, responding to criticism over the programmes comparatively high costs.
“We are used to seeing the NMFC programme from the point of view of adding human resources, but it’s also about the impact it makes for a community,” he says. It’s the impact of a community finally getting their own doctor. His argument is that, thanks to the NMFC programme, he got to be that person for his community.
By Matimba Ngobeni, Country Head: Value & Access, Novartis South Africa
28 July 2025, Johannesburg South Africa – South Africa’s healthcare system stands at a crossroads. Despite the promise of progress outlined in the Budget Speech and the Presidential Health Compact, the reality on the ground reveals persistent and growing barriers to accessing innovative medicines.
Economic pressures, funding constraints, and infrastructure gaps continue to undermine equitable healthcare delivery, particularly for vulnerable communities. What’s more, recent international developments—such as U.S. President Donald Trump’s cuts to funding that supported healthcare initiatives in South Africa—threaten to exacerbate these challenges, potentially limiting access to life-saving advanced therapies.[1]
Economic pressures
The cost of advanced therapies remains out of reach, and the structural inequalities in our healthcare system persist. While top-tier medical plans still provide access to advanced medicines, we are seeing a shift. Patients are moving to lower-tier plans or into the public system, simply because they cannot afford more. And with that shift, their access to advanced therapies disappears. [2]This is not a uniquely South African problem.
Globally, we see the same story repeat: private healthcare becomes a fortress that only those who can pay the toll may enter. Everyone else is left to rely on an overburdened public system, strained by funding shortfalls, infrastructure gaps, and critical workforce shortages. The public healthcare system, already overburdened, struggles to absorb this increased demand. Rising healthcare costs combined with limited household budgets create a perfect storm where affordability becomes the biggest barrier to accessing cutting-edge treatments.
Funding constraints and infrastructure challenges
Both private and public sectors face severe funding constraints. Innovative medicines, especially advanced therapies, come with high price tags that strain budgets and limit availability. At the same time, infrastructure and skills gaps hinder the effective delivery of these treatments. Investments in healthcare infrastructure, workforce training, and data management are urgently needed to support the growing demand for advanced therapies.
While it may seem like all hope is lost, the Presidential Health Compact offers a promising framework aimed at transforming South Africa’s healthcare landscape through infrastructure development and improved data surveillance[3]. However, it stops short of directly addressing access to innovative medicines. This gap underscores the need for stronger collaboration between public and private stakeholders to ensure that patients do not bear the financial burden alone.
Towards equitable access: Collaboration is imperative
Another way forward is through a robust, transparent Health Technology Assessment (HTA) process, where medicines are evaluated not only on their cost but on their ability to save lives, improve quality of life, and reduce the long-term burden on the health system.
Inclusive HTAs, where payers and pharmaceutical companies work together, are essential for reimagining access to advanced therapies. If we only look at the upfront cost of innovation, we miss the bigger picture of societal value.
Globally, risk-sharing models and outcome-based pricing agreements are helping bridge the affordability gap[4]. South Africa could benefit from more flexible legislation to enable these models, ensuring that innovation doesn’t remain locked behind prohibitive price tags.
South Africa’s healthcare future depends on what we choose to prioritise: short-term financial gains or long-term societal wellbeing. Too often, systems have been designed around protecting profits rather than protecting lives. Healthcare should never be a luxury. Yet in South Africa, and across much of the world, the reality is stark: exclusion is the norm, not the exception.
If we want a future where access to life-saving medicines is a reality for all, we need to break down the barriers of affordability, infrastructure, and policy inertia. And we need to do it together — governments, healthcare companies, funders, and civil society — because lives are at stake.
All hope is not lost. But we cannot wait for crisis to be our catalyst. The time for bold, collaborative action is now.
**About Novartis:**
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
Novartis South Africa (Pty) Ltd, Magwa Crescent West, Waterfall City, Jukskei View, 2090. Co. Reg. No. 1946/020671/07. Tel. No. +27 (0) 11 347 6600.
Disclaimer: The presentation may include data on formulations, products, indications, and dosages not yet approved by the South African Health Products Regulatory Authority. This information is not intended to be promoting nor recommending any formulation, indication, dosage, or other claim not covered in the approved Professional Information. Novartis South Africa (Pty) Ltd recommends the use of their products in accordance with the locally approved Professional Information. Views and opinions of speakers do not necessarily reflect those of Novartis.
#InsideTheBox is a column by Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. (Photo: Supplied)
By Andy Gray
For over 20 years, the law has required that the Minister of Health issues regulations to govern the advertising of medicines in South Africa, but as yet no such regulations are in place. In his latest #InsideTheBox column, Dr Andy Gray considers what this means for the marketing of medicines in the country.
Anyone who has travelled to the United States will have been struck by the extent to which medicines, both those requiring a prescription and those that can be bought by consumers without a prescription, are advertised on television.
The situation in South Africa is quite different. While there are many advertisements for medicines shown on local television stations, only some are specific about the proprietary (brand) name of the medicine and its indications. Other advertisements focus instead on the indication (the reason for using the medicine), but do not identify it by name. Instead, viewers are urged to approach their pharmacies or medical practitioners. At a different time, an advertisement may be flighted which identifies a medicine, its strength, pack size and perhaps price, but provides no information about what the indication for the medicine is.
To what extent does this represent meaningful and justified regulatory control over pharmaceutical marketing?
Only two countries with effective medicines regulatory systems allow prescription-only medicines to be advertised directly to the consumer, these being the United States and New Zealand. Other countries, including South Africa, restrict the advertising of prescription-only medicines to the health professionals who can prescribe or dispense them. One of the key justifications for this restriction on the ability of the pharmaceutical industry to market their products is that direct-to-consumer advertising may result in more inappropriate prescribing, when prescribers are under pressure from patients demanding medicines they have seen advertised. Short television advertisements are unlikely to be able to convey a balanced account of the potential benefits and harms of medicines, especially those that are new to the market.
South African law contains an interesting variant to regulation in this area. General Regulation 42 issued in terms of the Medicines and Related Substances Act, 1965, allows medicines containing substances in Schedules 0 and 1 to be advertised to the public, but requires that those containing substances in Schedules 2 to 6 to be advertised “only for the information of pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers” or “in a publication which is normally or only made available” to such persons. While Schedule 0 medicines can be bought in any retail outlet, Schedule 1 and 2 medicines can only be obtained from a pharmacy, but not self-selected from a shelf. The justification for that particular cut-off is difficult to trace in any policy document. An amendment to the regulation was published for comment in February 2023, but the final regulation has yet to be issued by the Minister of Health.
‘Failure to follow through’
The fundamental problem, however, lies in a failure to follow through on the legislation previously passed by Parliament. Section 18C of the current version of the Medicines and Related Substances Act, 1965, contains a prescriptive instruction to the Minister. “The Minister shall, after consultation with the relevant industries and other stakeholders, make regulations relating to the marketing of medicines, medical devices or IVDs and such regulations shall also provide for Codes of Practice for relevant industries,” it states. From 2003 to 2017, the section read: “The Minister shall, after consultation with the pharmaceutical industry and other stakeholders, make regulations relating to the marketing of medicines, and such regulations shall also provide for an enforceable Code of Practice.” The expansion of the remit, to include medical devices and in vitro diagnostics (IVDs) was added by Parliament in 2008, but only took effect in 2017.
The wording is peremptory – the Minister “shall” – which leaves no room for delay. While the word “enforceable” has been removed, the very intent of a regulation is that it should be enforced. That no regulations have been forthcoming in more than 20 years is an extraordinary failure of governance.
That failure is compounded by another act of omission. Section 18A of the Act states: “No person shall supply any medicine, medical device or IVD according to a bonus system, rebate system or any other incentive scheme.” The law also enables the Minister to “prescribe acceptable and prohibited acts” in this regard, in consultation with the Pricing Committee. No final regulations have been issued since 2017. The Pricing Committee is established to advise the Minister on matters relating to the pricing of medicines, such as the annual maximum increase and the dispensing fees charged by pharmacists and licensed dispensing practitioners.
It is already an offence, in terms of section 29 of the Act, for any person to make “any false or misleading statement in connection with any medicine, Scheduled substance, medical device or IVD”. Regulation 42 also states: “No advertisement for a medicine may contain a statement which deviates from, with or goes beyond the evidence submitted in the application for registration of such medicine with regard to its safety, quality or efficacy where such evidence has been accepted by the Authority in respect of such medicine and incorporated into the approved information of such medicine”.
While these two provisions may prevent false or misleading advertising, they are limited in their scope. In particular, since no complementary medicines are yet registered by the South African Health Products Regulatory Authority (SAHPRA), none have an approved professional information (previously known as a package insert) or a patient information leaflet.
Industry self-regulation
The pharmaceutical and medical devices industries have not been idle during this period of government inaction. A non-profit, self-regulatory body, the Marketing Code Authority (MCA), has developed a Code of Marketing Practice, drawing on international guidelines. This code provides for sanctions when rules are broken, following adjudication of a complaint. Fines of up to a maximum of R500 000 can be levied for severe or serious offences, which would, for example, pose “safety implications for patients”.
However, as a self-regulatory body, the MCA cannot require membership by any licensed manufacturer. It means that those manufacturers which are not members of the MCA are not bound by the Code and cannot be sanctioned. The MCA therefore advocates that compliance with a Code should be a condition to get a license to operate as a manufacturer. The MCA has also responded to draft regulations on perverse incentives.
At a time when deliberate disinformation is being disseminated from many quarters, including from government authorities previously considered to be reliable, a weakened regulatory system cannot simply be allowed to stagger along, in defiance of the express instructions of the legislature. Public safety demands an effective regulatory mechanism to proactively examine pharmaceutical marketing, across all media, the ability to take meaningful action where transgressions are identified, and an even playing field for all actors.
*Dr Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is part of a new series of #InsideTheBox columns he is writing for Spotlight.
Disclosure: Gray is a member of South Africa’s National Essential Medicines List Committee and co-chairs its Expert Review Committee.
Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.
Mothers of newborn babies, turned away at public clinics in Johannesburg because they are not South African, say their children are missing out on lifesaving vaccines.
In recent months, vigilante group Operation Dudula has been taking control of clinic queues across Johannesburg, chasing away immigrants or telling them to stand separately from South Africans. It is alleged that some healthcare staff have been participating.
This is despite a 2023 ruling in the Gauteng High Court that pregnant and lactating women and young children should be granted free health care services regardless of their nationality.
The court ordered the Gauteng Department of Health to change its policy denying immigrants healthcare, and to place notices on the walls at all healthcare facilities stating lactating women and children may not be denied access. This order is not being consistently complied with.
GroundUp visited the Jeppe Clinic last week and saw no such notice. There was a small group of Operation Dudula members pulling immigrants out of the queue and telling them to stand to one side.
Jane Banda, a Malawian national, was at the clinic. She has been struggling to get her seven-week-old baby vaccinated, but has been blocked every time by Operation Dudula. She fears her baby’s health may be at risk if she continues to miss essential vaccinations.
Aisha Amadu, an asylum seeker from Malawi, who has a two-year-old baby, had an appointment at Jeppe Clinic last week but was chased away by Operation Dudula.
Grace Issah, also from Malawi, has a 14-week-old baby who was due for a vaccine two weeks ago. But she has been chased away from clinics in Jeppe, Bez Valley and Hillbrow.
“I feel like giving up because it seems there is nothing that I can do. My husband has no money for private doctors,” she said.
Several other women said they have also been denied access to clinics in Malvern, Kensington, Rosettenville and Soweto.
The Socio-Economic Rights Institute (SERI) launched a case in the Gauteng High Court in 2024, on behalf of Kopanang Afrika Against Xenophobia (KAAX), the Inner City Federation, Abahlali BaseMjondolo, and the South African Informal Traders Forum.
The group is seeking an interdict to declare the actions of the vigilante group, which include denying healthcare to immigrants, unlawful. The matter was heard in June, and judgment was reserved.
Mike Ndlovu from KAAX says it is a constitutional right for everyone in South Africa to be able to access healthcare.
“What Operation Dudula and a few complicit nurses are doing is unconstitutional, a criminal act, and a betrayal of our democracy. Denying healthcare is a violation of basic human rights,” said Ndlovu.
Ndlovu called on healthcare workers to remember their professional duty: to care without discrimination.
Operation Dudula’s actions have been condemned by the South African Human Rights Commission.
Department of Health spokesperson Foster Mohale said the department is aware of the action by Operation Dudula, but denied that department staff members are involved.
“The health facility managers have been advised to alert the law enforcement agencies whenever they experience these protests because that is a security issue to enforce the law,” Mohale said.
Mohale did not respond to questions about whether the department has complied with the 2023 court order to put up the notices.
Zandile Dabula, spokesperson for Operation Dudula, did not respond to a request for comment. But Veli Ngobese, a member of the movement who was at Jeppe clinic on the day GroundUp visited, said: “We are targeting all people from outside the country. We want Home Affairs to start afresh. Foreign nationals who come into the country should come and invest because the ones we see are selling amagwinya [vetkoek], pushing trolleys, and selling peanuts, and we are the ones paying taxes.”
He said the group will be conducting daily protests until immigrants stop going to clinics.
During South Africa’s COVID-19 hard lockdown, Dr Sandile Cele became the first to successfully grow the beta variant of SARS-CoV-2 in the lab. PHOTO: Rosetta Msimango/Spotlight
In a Durban laboratory in 2020, there was dancing and scientists jumping with joy when Dr Sandile Cele realised they had finally successfully “grown” the SARS-CoV-2 Beta variant. It was the holiday season and Cele and a few colleagues had sacrificed their Christmas to continue research at an otherwise deserted laboratory.
The Beta variant (501Y.V2) was first detected in the Eastern Cape in October 2020 and was announced to the public on 18 December that year.
“It was December 2020 and Tulio [Professor Tulio de Oliveira] had just flagged the beta variant and we had been struggling trying to grow it, really struggling for about two weeks,” says Cele. “But then as a scientist, you have to think outside the box and eventually it [the virus] did catch on. I was with Professor Alex Sigal that day in the laboratory. We were so excited. There was a lot of dancing in the lab, jumping up and down…”
The 35-year-old’s work on the Beta and Omicron variants helped propel South Africa to the forefront of COVID-19 research. Cele is the scientist credited with growing both Beta and Omicron in record time as the world reeled under lockdown pressure. Last year, he was awarded a special ministerial Batho Pele excellence award for his contribution to COVID-19 research in South Africa.
The moment of greatest fulfilment
Speaking to Spotlight, Cele says growing the beta variant was the moment of greatest fulfilment in his career so far.
“It was just a crazy, crazy moment. Like, you know when you are with your superior, usually you meet on a basis of respect. I mean, you talk seriously. They ask a question, you answer, and so on. But [at] that moment, all that got thrown out the window. We were celebrating. So yes, it was really special.”
At the time, they were leaping with joy inside PPE (personal protective equipment), including specialised masks, double gloves, plastic sleeves, and boots. Cele points out that due to all the safety measures in place, infection risk was smaller in their lab than at an average mall.
He was working inside a state-of-the-art biosafety level 3 (BSL-3) laboratory at the Africa Health Research Institute (AHRI). The laboratory is on the third floor of the University of KwaZulu-Natal’s medicine building. In the same eight-storey glass and face brick building, on the first floor, de Oliveira had been studying virus samples for genetic clues at KRISP, the KwaZulu-Natal Research and Innovation Sequencing Platform, from where the discovery of Beta and Omicron was first announced.
How he did it – growing the beta variant
Cele explains that viruses are isolated or “outgrown” by infecting cells in the laboratory, using swab samples from infected individuals.
“Growing a virus simply means isolating it from an infected host (humans) and making more of it in the lab for research purposes,” Cele explains. “You cannot study a virus within an infected person, especially a new virus. You need to have it in the lab for identification and clarification. Usually, you get small quantities from an infected person, thus you have to expand or grow – or make more of it – for research.”
Photo by Shvets Production on Pexels
However, the beta variant had not responded like previous SARS-CoV-2 variants. At the time, Cele found a creative solution using both human and monkey cell lines. First, he infected human cell lines with the beta variant, incubating the assay for four days. Then he used the infected human cell lines to infect monkey cell lines, which successfully lead to production of the virus.
Their moment of triumph arrived when they noticed the monkey cell lines starting to die, meaning that the virus was growing. The isolated virus could then be used in the laboratory to run experiments, like testing vaccine efficacy.
“Looking at the cells under the microscope, you can see them starting to die,” he says. “That they’re not happy. That they have been infected, which then obviously needed to be confirmed.”
While Cele’s Durban mentors – de Oliveira and Sigal – kept the public abreast of research developments, the young scientist kept his head down, pouring over his microscopes. “The world was going crazy, everything was crazy, but I had work to do,” he says.
‘a rising star’
During the interview, Cele readily shares anecdotes and laughs often.
From Ndwedwe, a rural area forty kilometres north of Durban, Cele joined Sigal’s laboratory team at the AHRI in 2014, where he studied HIV drug resistance and later COVID-19. His PhD obtained from UKZN in 2021, focused specifically on understanding the beta variant and its escape from antibodies.
“Actually, Professor Alex Sigal really took a chance on me,” he says. “Because on that post for a laboratory technologist, they stipulated that they wanted someone with three years experience. And I had only been doing my internship [at the Technology Innovation Agency] for eight months.”
But Sigal’s faith paid off, and he subsequently praised Cele in national press interviews on COVID-19. “Sandile is a rising star who spent all his holidays in a laboratory,” Sigal told journalists in January 2021.
Last year, the Bill and Melinda Gates Foundation invited Cele to present his findings at the Grand Challenges Annual Meeting in Brussels. This was his first time abroad. “It was my first time traveling outside South Africa and my first time talking in front of so many people. I presented my go-to talk – based on a paper I did on COVID-infection and HIV – and it went well,” he says.
Earlier this year, Cele was named one of Mail & Guardian’s 200 trailblazing young South Africans in the technology and innovation category. At the time, he could not attend the gala event as he was at the University of Nairobi in Kenya for training relating to a project involving HIV research for the Aurum Institute. Cele started a new job at the Aurum Institute in Johannesburg in March.
Over Zoom, Cele is speaking from his new home in Johannesburg. He is wearing a fluffy blue robe over his clothes, laughing as he says how cold Johannesburg is coming from Durban.
A sudden death
In Ndwedwe, Cele was one of ten boys born to his father, who was away from home often for work. Describing his mother as “a busy lady”, Cele says she was the one who shaped his young everyday life. Growing up in a mud hut without electricity and running water, he recalls how his mother would get up early every morning to prepare vetkoek, which she sold at a local school, and to boil water so her children could have a bath before leaving for school.
In the afternoons, he would look after his father’s goats and play soccer. He says that as a child he preferred herding goats to cows, as goats grazed for only about five hours, whereas cows took all day to eat their fill. From Grade 9 on, he attended school in Durban, at Overport Secondary School.
A childhood memory that inspired him? “Before my mother died, she sat us down and said one day I will be gone and I want you to know there are no shortcuts in life. Work hard and look after one another and you will be okay.”
His mother’s death was sudden, following complications from minor surgery.
“Like, I came back from school on a Friday only to find my father wasn’t around and had left a note… On the Saturday morning, I found out my mother had passed. And I think she went for, I don’t know, an operation or something. But as a kid, I guess they didn’t tell us because they thought it was something minor; that she would get operated [on], then go back home. I’m not really sure what happened. So, yes, it was a sudden death.”
The year after his mother died, Cele’s matric marks suffered. He says his final grade 12 marks had been 48% for maths, 53% for physics, and 66% for biology.
“I wasn’t really studying, I couldn’t really concentrate,” he says. “There was a lot going on when I was doing my matric. My mother passing away… and also the move from a rural school to the city where we were taught in English, everything in English.”
Cele came to study biology quite at random. He applied to study at UKZN only in October of his matric year – with admissions to most of the university’s courses having closed the previous month. He picked one of the last remaining options, which had been biology.
Soon, the young student started excelling. Cele obtained his BSc Biomedical Sciences degree with a Dean’s commendation and his Honours in Medical Microbiology, summa cum laude. He completed his Masters in Biochemistry with an upper-class pass.
To the Mail and Guardian, he shared advice he would give to his younger self: “Do not be afraid, you are a force to be reckoned with.”
Cele’s driving passion is to advance public healthcare, which he will continue to do at the Aurum Institute – an organisation that amongst others does research into Africa’s tuberculosis and HIV response. Cele has a ten-year-old son who lives in Durban.
Note:The Bill and Melinda Gates Foundation is mentioned in this article. Spotlight receives funding from the foundation, but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council.
The Global Fund to Fight AIDS, TB and malaria (Global Fund) has notified Health Minister Aaron Motsoaledi that it will reduce funding to South Africa by R1.4-billion.
Global Fund said it would be reducing allocations for the seventh grant cycle from R8.5-billion to about R7.1-billion, a 16% reduction. Of this, 55% would be allocated to the National Department of Health and the rest to non-profit organisations such as the Networking HIV & AIDS Community of Southern Africa, Beyond Zero, and the AIDS Foundation of South Africa.
The fund informed recipient countries in May that it would be revising over 200 grants amidst funding shortfalls.
Global Fund was established in 2002 and provides funding for HIV, TB and malaria programmes in over 100 countries. According to its 2024 results report, 72% of its funding from 2021 to 2024 went to sub-Saharan Africa.
Other African countries also received notification of funding cuts. Mozambique’s allocation decreased by 12%, Malawi’s by 8% and Zimbabwe by 11%.
The shortfall in funding is due to Global Fund not having received money pledged by national governments. Over US$4 billion of the shortfall is due to the United States not fulfilling its pledge.
We reported last month how Mozambique’s health system has crumbled amidst USAID funding cuts.
In South Africa, funding cuts from PEPFAR earlier this year have led to clinics closing down, health staff getting retrenched, and people struggling to access HIV medication.
“As you know, the external financing landscape for global health programs is going through significant changes, with substantial impact on lifesaving services for the fight against the three diseases and health and community systems,” the Global Fund said in its letter to South African representatives.
The letter continued that while the Global Fund has “received some significant donor payments in recent days”, prospects to give the full grant cycle 7 (GC7) pledges “remain highly uncertain” and still face a risk of funding shortfalls.
“This is a difficult and unavoidable decision, which may require your country to reconsider how best to use the remaining GC7 grant amounts together with domestic resources and other sources of funds to keep saving lives,” the Global Fund said.
Foster Mohale, Department of Health spokesperson, said that the funding cut did not come as a surprise. Mohale said the department is “working with the provinces” to ensure that “service delivery” is not disrupted, and to apply measures to ensure “efficient use of limited resources”.
As we commemorate Mental Illness Awareness Month and Psychosocial Disability Awareness Month, a staggering 92% of South Africans living with mental health conditions are not receiving the treatment they need. Yet, research continues to show that collaborative care—where mental health and primary care providers work together—can significantly improve patient outcomes, service satisfaction, and overall quality of life. People with serious mental illness (SMI) are particularly vulnerable as SMI is associated with marked functional impairment and high levels of stigma. SMIs typically include psychotic disorders, bipolar and related disorders, major depression, and severe anxiety and stress-related disorders.
A new study published in Cambridge Prisms’ Global Mental Healthexplores how integrating community psychiatric services into primary health care (PHC) clinics improves access for individuals with SMI in South Africa. However, the study also reveals persistent challenges related to limited resources, weak management systems, and fragmented collaboration between health care providers as key setbacks.
Conducted in the Sedibeng District, the research forms part of a broader study series focused on patients’ experiences. It is modelled on global evidence to assess the impact of community-based collaborative care—a model increasingly adopted worldwide to strengthen mental health delivery in PHC settings.
Why Integrated Mental Health Care?
Also known as Integrated Care, this health care model plays a vital role in improving access to mental health services by bringing care closer to communities. It relies on bringing together PHC providers such as physicians, nurses and mental health providers to deliver coordinated, person-centred care.
Integrated care is believed to yield better health outcomes for individuals living with SMIs, who often have comorbid physical health conditions. Saira Abdulla, the lead researcher in the study and Wits PhD fellow based at Centre for Health Policy says the paper highlights key shortfalls in how collaborative care is implemented in this district. This includes poor communication, unclear roles within multidisciplinary teams, and the absence of case managers to coordinate care, with providers instead coordinating care in an ad-hoc manner.
Infrastructure and Staffing Challenges in Integrating Mental Health into Primary Care in Sedibeng
In the Sedibeng District, community-based psychiatry services have been integrated into select primary healthcare (PHC) clinics through two operational models: co-located and physically integrated services. In co-located settings, psychiatric teams operate from separate spaces adjacent to PHC clinics and use independent systems for clinical records. By contrast, physically integrated services are delivered within the same spaces as PHC clinics, using shared management structures and record-keeping systems.
However, a recent study reveals that PHC facilities in the district are not adequately designed to support the specific requirements of psychiatric care. The lack of private, secure consultation spaces compromises confidentiality, as mental health consultations often take place in shared rooms used by multiple healthcare providers.
Physically integrated clinics were found to be particularly constrained, with concerns ranging from overcrowded waiting areas—often without seating—to general safety risks. These conditions compromise the therapeutic environment essential for effective mental health care and highlight the broader systemic challenges of integrating psychiatric services meaningfully within the PHC framework.
The study also underscores a critical shortage of human resources. Most clinics have only five psychiatric nurses on site, while two to four doctors rotate between clinics, offering adult psychiatric consultations just once a week. With monthly patient volumes ranging from 580 to 910, the current staffing levels severely limit the ability to deliver consistent, high-quality care.
Key findings
· Integration does not guarantee collaboration
While all the elements of full collaboration were not achieved in either setting, the physically integrated setting provided a better opportunity for communication among staff (due to shared files, physical proximity and good management with mental health interest and experience) However, these advantages were still hindered by poor infrastructure and inadequate resources.
· Integration Models Matter
The study found that physically integrated clinics (shared space and records) had better communication and collaboration between mental health and PHC providers. Co-located clinics (separate buildings and records) suffered from poor communication and siloed teams.
· Resource and Infrastructure Constraints
Both clinics faced inadequate space, supplies, and staff, although the physically integrated clinic was the most under-resourced. In both settings, insufficient resources were further exacerbated by high caseloads.
· Leadership is Critical for Collaboration
The study highlighted the importance of management in fostering teamwork. Stronger leadership qualities were evident in the physically integrated clinic, which led to reduced staff conflict and improved communication. In contrast, the co-located clinic was impacted by poor management and a lack of managerial oversight, leading to conflict among staff members. The failure to appoint a permanent Chief Director at the district level has also led to a lack of strategy, and frustration among clinic staff.
· Resistance from PHC Doctors to Manage Mental Health
PHC physicians and doctors are often reluctant to manage stable psychiatric patients, leading to unnecessary referrals. Some providers did not feel equipped to provide quality care and others felt that collaborating with community psychiatry staff would increase their workload.
As low and middle-income countries move towards integrating mental health into PHC, this paper highlights that the type of integration approach needs to be functional at all levels to enhance the health outcomes of the most vulnerable.
