The South African Health Products Regulatory Authority (SAHPRA) encourages members of the public to always report any suspected side effects they may experience from taking medicines, vaccines and/or using medical devices, to help make medicines safer for everyone. While humanity benefits greatly from medicines in the treatment of illness and management of certain conditions, medicines may at times cause side effects. However, the risk of side effects and severe harm can be drastically reduced by taking medicines correctly and following the advice of a healthcare practitioner.
SAHPRA, together with over 90 other medicines and health products regulators as well as healthcare organisations globally, is participating in the annual #MedSafetyWeek awareness initiative, which takes place between 4 and 10 November 2024, under the theme “the importance of using medicines in the right way to prevent side effects, and to report side effects when they do occur”.
The awareness initiative is spearheaded by the Uppsala Monitoring Centre under the auspices of the World Health Organisation (WHO) Programme for International Drug Monitoring, a programme whose member organisations work nationally and collaborate internationally to monitor and identify adverse effects of medicines and vaccines, to reduce risks to patients, and to establish worldwide pharmacovigilance standards and systems.
During this #MedSafetyWeek and beyond, SAHPRA is calling upon patients, caregivers and healthcare professionals to utilise its reporting tools to report all suspected side effects and adverse reactions.
SAHPRA Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, indicates that handling and storing as well as taking medicines as directed by a healthcare professional is key in reducing the incidence of adverse reactions. “Research shows that about half of all side effects are preventable. Patient safety is our top priority and during #MedSafetyWeek, we wish to remind patients to take their medicines as instructed and healthcare professionals to review therapies as well as each patient’s unique health conditions before prescribing or dispensing medicines,” says Dr Semete-Makokotlela.
SAHPRA calls upon the South African public and healthcare professionals to use either the MedSafety App or the eReporting portal both accessible on the SAHPRA website to report suspected side effects from health products. All reports are assessed and examined by SAHPRA to determine the correct steps to protect medicine users in South Africa from harm. The purpose is to gain better knowledge about known side effects and to discover new ones. This can result in warnings and changes to how a medicine is used. SAHPRA’s MedSafety App and eReporting portal can be used for reporting suspected adverse drug reactions from medicines, vaccines, herbal products, biological medicines and any quality issues relating to health products.
Bada Pharasi, CEO of The Innovative Pharmaceutical Association of South Africa (IPASA)
Imagine a healthcare system which ensures that every patient’s voice helps shape their treatment, where barriers to life-saving care are dismantled, and where innovation is driven by meaningful collaboration. In South Africa, this vision is no longer a distant aspiration; it’s an urgent mission to create a system that truly serves its people, writes Bada Pharasi, CEO of the Innovative Pharmaceutical Association of South Africa.
South Africa’s healthcare system stands at a critical crossroads. Despite remarkable medical advancements, countless patients remain on the sidelines, hindered by financial, regulatory, and logistical barriers. Today, there’s an opportunity to reshape this reality by building a patient-centred healthcare model that expands access, amplifies patient voices, and creates strategic partnerships.
Empowering patient voices
In a truly inclusive healthcare system, patients aren’t just recipients of care; they are active contributors. By integrating patient perspectives into decision-making, healthcare becomes more responsive to those it serves.
Through collaborations with patient advocacy groups, educational campaigns, and year-round initiatives, there’s a growing movement to create an environment in which patients feel heard and empowered to influence the care they receive. While events such as World Patient Safety Day help highlight the importance of prioritising patient needs, the goal is to make this a constant focus, not just an annual observance.
Key prerequisites for achieving this are efficient regulatory frameworks, impactful public-private partnerships, rare disease management, and a true commitment to innovation.
Streamlined regulatory partnerships
Timely access to groundbreaking treatments depends on efficient regulatory frameworks. Collaborating closely with regulatory authorities such as the South African Health Products Regulatory Authority (SAHPRA) is pivotal in expediting access to new therapies.
Such partnerships ensure that treatments meet rigorous safety standards while streamlining approval processes so that life-changing therapies reach patients without unnecessary delays. Maintaining high standards for post-market safety also strengthens public trust and reinforces the resilience of the healthcare system.
Public-private partnerships: Catalysts for innovation
Expanding access to quality healthcare in South Africa demands strong public-private partnerships (PPPs) that leverage both public resources and private sector innovation.
Collaborative efforts with the Department of Health and other key stakeholders maximise impact by ensuring that resources are effectively allocated and that patients benefit from the latest treatments. These alliances are vital for achieving universal health coverage (UHC) under the National Health Insurance (NHI) framework, helping to ensure that equitable, high-quality healthcare becomes a reality for all.
Closing gaps in rare disease management
For patients with rare diseases, access to treatment is often riddled with obstacles, from limited therapies and high costs to a lack of awareness. Multi-stakeholder collaborations, including advisory boards initiated by organisations such as Rare Diseases South Africa, bring together patients, healthcare professionals, and industry experts to advocate for better support and access to treatments.
This prioritisation of open communication and patient-centred outcomes offers hope to rare disease patients who, through these partnerships, gain better access to essential treatments and the support they deserve.
Breaking down barriers to innovation
The drive for a more accessible healthcare system also requires addressing policy barriers. Streamlined processes, simpler registration pathways for new drugs, and patient-centred reimbursement policies ensure that patients receive the right treatment at the right time.
Working alongside policymakers, healthcare providers, and civil society, a concerted effort is being made to create a system in which innovation and equity go hand-in-hand to provide better outcomes and quality of life for all South Africans.
Shaping the future of healthcare
The future of South Africa’s healthcare lies in a system that prioritises patients, breaks down barriers, and capitalises on partnerships to make innovation accessible.
The call to action is clear: build a healthcare ecosystem that is dynamic, inclusive, and adaptable to ensure that every South African has access to the care they need. By promoting patient voices and ensuring collaboration across sectors, we can transform South Africa’s healthcare system to be more responsive, resilient, and equitable – a system that truly serves its people.
To see National Health Insurance primarily as the setting up of a state-run medical aid scheme risks underplaying its massive potential to restructure how public healthcare services are organised and funded, and with that, its potential to boost the delivery of primary healthcare services in South Africa, argues Russell Rensburg.
It has been 30 years since South Africa emerged from centuries long racial suppression and state-sponsored apartheid and took her place among the community of sovereign, democratic nations. In 1996, we adopted the final Constitution, in which we committed to addressing the injustices of the past and building a society based on social justice and human dignity. That promise is carried through in the Bill of Rights, which under Section 27 includes the right to healthcare, food, and social assistance. The right to access healthcare services, like many socio-economic rights, is subject to the state taking reasonable legislative and other measures within available resources to progressively realise the right.
Pursuant to this, the National Health Act, which provides the framework for a structured uniform health system within the country, was adopted in 2003. The Act assigns the minister of health the obligation to ensure the provision of essential health services, which must include primary healthcare services. But, to date, no health minister has published regulations that define the exact scope of essential health services, nor has a framework been offered for the development of a defined package of care to be provided within the resources available.
The result is that, despite significant investments in public funded healthcare, the system and the services it provides has largely been shaped by existing infrastructure inequity. Put differently, health investments have typically gone where the infrastructure exists, rather than being guided by providing a defined package of primary healthcare services in all the places where it is most needed.
In the near term, the health system faces several immediate challenges. Per capita spending is declining. Spending is biased towards hospitals, with 42% of the national health budget spent on central and provincial hospitals. Another problem is that health service planning and budgets do not sufficiently account for our changing demographic profile – life expectancy has increased and we have a growing population of young people.
The National Health Insurance (NHI) Act is an attempt to address this through the establishment of the national health insurance fund, which initially will be the only purchaser of public sector healthcare services. Broadly, the NHI aims to pool funds to provide access to good quality, affordable healthcare services for all South Africans and certain foreign nationals, based on their health needs and irrespective of their socio-economic status.
This shift marks a substantial change from the existing setup, where 85% of the national health budget is allocated at the provincial level. In South Africa, the share provinces get of the national budget is largely determined by the equitable share formula. The health component of the formula includes a number of variables to account for healthcare need, including premature mortality (as a proxy for unmet need ), multi index deprivation (to account for social determinants of health such as poverty ), income, housing, and measures of sparsity (to account for rurality). But the biggest driver of funding is historical utilisation, which shapes resource allocation at the provincial level. The result is that the funding is overly focused on providing care under the existing systems, rather than progressively expanding access to healthcare, and boosting access to primary care in particular.
In short, NHI represents a major shift away from this paradigm by which provinces receive healthcare funds via the equitable share and based on historic spending.
How it will work
Under NHI, the public sector will budget according to level of care, initially prioritising the district health system through the establishment of district health management offices. These offices will support contracting units for primary care, which will comprise a district hospital, community health centres , primary healthcare clinics, and ward based outreach teams as well as provisions for integrated practice comprising GPs, pharmacists, dentists, and rehab professionals (occupational health, physiotherapy, and speech therapy). The district health management offices will be responsible for the achievement of health outcomes in districts.
In theory, this will allow for healthcare priorities to be shaped at the district level and for services to be more responsive to the healthcare needs of communities. For example, a district like OR Tambo could prioritise more resources towards addressing maternal mortality by expanding ante-natal services or developing responses to address the health access gaps for older people in rural areas. In urban districts, like the City of Johannesburg, it could prioritise expanding access to reproductive health services by contracting in private health providers who are better placed to respond to the needs of working women. Ultimately, such a shift to a more responsive and more localised health system could also help increase uptake of TB and HIV prevention and treatment services across the board.
How to get the ball rolling
Reorientating our health system towards primary healthcare will be a difficult and time-consuming process, given the complex nature of health systems. But, there are things we can do right away to get things moving. We don’t have to wait for full implementation of NHI.
The current District Health Programme Grant can be expanded to enable provinces to increase primary healthcare services. The grant currently focuses on resourcing the country’s response to HIV, which seems to have reached a plateau with fewer people initiated on treatment. Contracting in private providers using this grant could improve service accessibility for testing, reproductive health services and routine healthcare for the working poor. Indeed, contracting in non-state healthcare providers, such as healthcare NGOs, pharmacies, and GPs, can significantly improve the patient experience and help build the public trust that is needed for NHI. As we repurpose the District Health Programme Grant, we can also start building the systems we will need for the district health management offices envisaged under NHI, thus helping to ease the transition when it comes.
The biggest immediate opportunity however lies in improving the accessibility and acceptability of district health services for the working poor. A study by the Bureau of Market Research at UNISA estimated that around 75% of working people in South Africa earn less than R6 000 a month. The current structure of publicly funded primary healthcare services do not respond to their routine needs, which include accessing family planning, seeing a GP when ill, a dentist to address oral health issues or access to rehab services. Apart from meeting the needs of these people, expanding service points, particularly in urban areas, can also improve disease surveillance through increased testing, and increased uptake of HIV prevention and treatment services.
There are more areas where we can make progress now that will ease the transition to NHI. For example, the current National Tertiary Services Grant, with an allocation of R15 billion, can be used to support a deep dive into what services our hospitals offer, what resources they are allocated and why, and how all of that lines up with the health need in our districts. The data isn’t currently there to really know whether we are getting value for money from our public hospitals. As with primary care, we need to get a clearer understanding of the need and start re-engineering the system so that we are in a better position to meet that need as we start implementing NHI.
Ultimately then, it is limiting to think of NHI exclusively as the establishment of a state-run medical aid scheme – as it is often portrayed in the media. A public discourse dominated by debates over the future of medical schemes risks obscuring the substantial potential NHI offers for improving and restructuring how public health services are organised and funded. The reality is that with NHI, we have an opportunity to shift the focus of our healthcare system toward primary healthcare and in the process to make our health system much more efficient and equitable. It is imperative that we do whatever is needed to deliver on that potential.
*Rensburg is Director of the Rural Health Advocacy Project.
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.
Family physicians undergo an extra four years of training, with an emphasis on clinical governance and knowledge of social factors influencing people’s health. Photo by cottonbro studio
By Chris Bateman
Around twenty years ago, family physicians seemed set to take up roles as critical cogs across South Africa’s public healthcare system, but in the years since, doctors trained in this speciality have largely been underutilised. That is now finally set to change, according to the Department of Health, Chris Bateman reports.
The National Department of Health has signalled that they want to see more family physicians appointed as clinical managers tasked with leading multi-disciplinary district hospital teams. This follows years of lobbying by the South African Academy of Family Physicians (SAAFP) advocating for the greater utilisation of family physicians in the country’s public healthcare system.
The SAAFP has long argued the cost and clinical effectiveness of these “super generalists”, who undergo an extra four years of training, with an emphasis on clinical governance and knowledge of social factors influencing people’s health. And it seems their patience has been rewarded with a five-year district health blueprint from government.
This was confirmed to Spotlight by Dr Luvuyo Bayeni, Chief Director of Human Resources for Health at the National Department of Health.
Advocates for the speciality argue that family physicians have been neglected, with posts thin on the ground and their potential contribution under-estimated. The discipline was registered with the HPCSA in 2007.
Professor Bob Mash, Distinguished Professor at Stellenbosch University where he heads the Division of Family Medicine and Primary Care, describes the specialty as “one of the most underutilised solutions to many of the problems facing district health service delivery”. Mash is the immediate past president of the SAAFP.
Bayeni, a former clinician/administrator in the Eastern Cape, was appointed to lead the health department’s human resource operations in July last year. Since then, he attended the last two annual SAAFP conferences and has been meeting regularly with the academy’s leadership.
With austerity measures being the catch-all rebuttal by provincial heads of department whenever the wisdom of freezing posts is questioned, Bayeni is trying to persuade his provincial counterparts to adopt a policy of appointing family physicians to clinical manager posts as a highly cost-efficient move, citing successes in the Western Cape. The idea is that family physicians are able to quickly diagnose and treat patients while mentoring junior colleagues. They also help design or tweak hospital and referral clinic systems for efficiency and identify preventative health interventions at community level.
Blueprint approved
In a wide-ranging interview with Spotlight, Bayeni said his family medicine oriented blueprint had been approved by the Presidency’s Department of Policy Planning, Monitoring and Evaluation for inclusion in all future health indicators. His plan is to initially get family physicians as clinical managers into all medium to large district hospitals (150 beds and above), before ensuring they are placed in every health district, including at lower level hospitals and community health centres, at all times leading a multi-disciplinary team.
“Instead of waiting for HR plans and organograms, this is going into the mid-term framework for monitoring. It’s a strategic opportunity, where we ask ourselves, ‘how do we define a multi-disciplinary team for a district hospital?’ and then work through and with them. We’ll define and map where our priority district hospitals are, starting with the medium to large district hospitals,” he said.
Bayeni said he met with his provincial counterparts and military health service chiefs last week, (14-18 October), where he said he was going to, “make sure they all know about this. Organograms are all fine and well and necessary, but I want this top of mind when they consider them.”
“Personally, by April next year, (the new financial year), I want to see more family physicians being appointed, either in the district or in the position of clinical managers wherever there are vacancies. I’ll ask the provinces to help me with monitoring and evaluation,” he said.
He said his ambition is to change the mindset of provincial healthcare leaders “wherever necessary” about family physicians being regarded as “just another specialty” when creating and enumerating posts.
Positive responses
Several top family medicine academics and clinicians around the country who have been at the forefront of providing data and lobbying for a more pragmatic healthcare delivery approach, welcomed the renewed focus on family physicians.
Professor Steve Reid, a veteran rural family physician and head of Primary Health Care at the University of Cape Town (UCT), told Spotlight the main problem was what he called a framing issue.
“The way we think about medicine is to just go to the doctor and get it sorted, rather than how a huge number of diseases can be managed and prevented early on – it’s been a major shift over the last fifty years. I mean we now have studies that link pre-natal health to later chronic diseases. The whole idea of social medicine went out of vogue, and the idea that health has far more to do with the social determinants of health than it has to do with the health system had too little purchase,” he said.
Reid observed that no family physician can work in isolation – they made the most difference when they had a multi-disciplinary team around them.
Labelling family physicians “boundary-spanners par excellence”, he said “they join the dots rather than work in silos like other specialties who tend to guard their turf jealously.”
“Brazil is a middle-income country just like South Africa and their simple model of one doctor, a nurse and four to six community health workers per 4 000 population has got 80% of their population covered, including vast urban areas like Sao Paulo and Rio de Janeiro,” he said. In South Africa’s case, having a family physician as the leader will further enhance this model.
‘Around 400 needed’
Mash said South Africa’s previous health policies saw family physicians as a sub-specialty of internal medicine or as specialists who should work at tertiary hospitals and within primary care teams. Currently, chiefly due to the lack of posts, only a third of family medicine graduates were retained in the public sector, with ten percent emigrating and eleven percent giving up medicine altogether. Most were employed in the Western Cape, where the health system had committed to appointing family medicine practitioners at district hospitals and primary care facilities, Mash added.
The SAAFP recommends a mid-term goal of one family physician at every district hospital, community health centre or sub-district.
To achieve this, said Mash, another 400 family physicians are needed, but at current training rates this could take up to two decades, (not accounting for the current shortage of posts).
He agreed with Public Health Medicine Specialist Tracey Naledi, that only when there’s wider and stronger investment in primary healthcare across provinces will better deployment of Family Medicine practitioners begin to make a real difference to district level health and wellness. Naledi is Associate Professor in Public Health Medicine and Deputy Dean of Social Accountability and Health Systems at UCT’s Faculty of Health Sciences.
Naledi said that while there are many highly skilled veteran ‘utility’ Medical Officers in the district health system, the greater utility of family medicine is in clinical governance, health systems strengthening initiatives and capacity development. Besides teaching, monitoring, and evaluating healthcare delivery, she said family physicians also more appropriately and timeously refer patients to secondary and tertiary care.
Specialist support
“The family physicians should not just be seeing sixty patients at their door daily. They are specialist support – the Medical Officers should be calling them for advice. If family physicians were optimized, we’d see far less referral to tertiary level services,” she said.
The problem is structural, she believes.
“There are not enough human resources for health in general, so at district level people get pulled into doing what’s needed on the shop floor. There’s not enough time to do the strategic work,” she said.
“You can’t just talk about family medicine without talking about full staff requirements. When a family physician goes on outreach, it should not just be about dealing with difficult cases but building the capacity of the outlying areas. They need to ask themselves what they’re leaving behind. Otherwise, you’re cleaning the floor but not closing the tap,” she added.
Mash agreed that family medicine practitioners are “not the magic bullet – but introducing them into district health services can go quite a way towards strengthening the system”.
“We’ve trained them to work independently, to be the senior clinician with the full spectrum of needed skills, on top of which they provide the confidence for the doctors who are there to practice the skills they have. It’s very reassuring having a senior person to help if things go wrong, so it’s a combination of increased confidence and bringing in additional skills,” he said.
“A primary health nurse and community health worker can provide coverage and connection to the community, but a [family medicine] FM practitioner brings in a level of expertise so the team has both coverage and quality,” he added.
History and training
As Mash tells it, from the nineties into the first decade of the 2000s, no medical schools exposed undergraduates to Family Medicine. However, nearly thirty years on, curricula have completely turned around.
Mash says some twenty to thirty family medicine practitioners graduate from the ten South African campuses every year, among the chief disincentives to the specialisation being the paucity of available posts. He said it’s critical to create more family medicine posts “if we are to attract people into that career path. If managers believe a family physician’s contribution is worthwhile, they can outmanoeuvre these restrictive budgets.”
He said public health was being “hugely damaged” by an austerity mindset.
Professor Shabir Moosa, Family Physician in the Department of Family Medicine at Wits University, suggested offering a two-year distance learning diploma in family medicine to get family medicine practitioners into practice faster and then offering in-service further tuition to a full post-graduate degree. Moosa is a former President of the World Organization of Family Doctor’s Africa region.
“Right now, you have family physicians in community healthcare centres which see a thousand people a day. Their job is capacity building, but they’re stuck with menial tasks. Also, right now qualified Family Medicine practitioners, at Wits at least, have a thirty percent teaching commitment so they’re being pulled in many different directions.”
Like Mash, he said “turnstile leadership” in the provinces wrecked progress while leadership in primary healthcare at district and lower levels was mainly by nurses, who were uncomfortable sharing space with family physicians whom they saw as a “power threat”.
Moosa says most family medicine practitioners in rural South Africa (with the exception of the Western Cape), are foreign qualified doctors who found studying it an “easy entrance route”. He takes issue with the emphasis on training family physicians exclusively for use in rural areas, saying that with accelerating urbanisation, this is short-sighted.
Parallel with clinical associates
Associate Professor Tasleem Ras, President of the SAAFP and Postgraduate Programme Director of Family Medicine at UCT, drew a parallel with clinical associates which some provinces had adopted and others not, saying they had no career pathways which has become “a political hot potato”. (Spotlight previously reported under the under-utilisation of clinical associates here and here.)
Ras was alluding to the provincially disparate usage of both categories of healthcare professionals. In the case of family physicians at least, senior medical officer and registrar posts are being creatively used by some provinces to place them, with salary adjustments built in. Clinical associates have no such luxury.
Naledi says she suspects that healthcare delivery leaders in individual provinces have widely differing views on how to use family physicians, with commensurately differing patient care outcomes. She says the grading of healthcare facilities by the Office for Healthcare Standards Compliance eloquently illustrates an overemphasis on curative service-based funding, with lower-level primary healthcare facilities scoring worst, followed by secondary or district hospitals with tertiary hospitals scoring the highest. Unless this changes, she says “we will continue failing to get bang for buck”.
She adds: “If you look at the district health system, it doesn’t have the full cadre of staff. I mean palliative care, mental health, dental services – these are all structural and broader resource issues for me. You can’t look at family medicine in isolation.”
The argument is that building more capacity for prevention and health promotion would begin to dismantle a self-perpetuating cycle of predominantly curative services. Family medicine training, Naledi says, focuses a lot more on the social determinants of health, prevention, rehabilitation, and palliative care. “It’s not just about clinical abilities but about them being family and community doctors,” she adds.
In June, we heard what could be this year’s biggest HIV breakthrough: a twice-yearly injection can prevent HIV infection. Findings from a second large study of the jab has now confirmed that it works. Elri Voigt goes over the new findings and unpacks the licenses that are expected to facilitate the availability of generic versions of the jab in over a hundred countries, including South Africa.
The second of two pivotal studies of a six-monthly HIV prevention injection containing the antiretroviral drug lenacapavir has confirmed that the jab works remarkably well.
The first study, called PURPOSE 1, found that the jab is safe and highly effective at preventing HIV infection in women. The second, called PURPOSE 2, found the same for cisgender men, transgender men, transgender women and non-binary people who have sex with men assigned male at birth.
Interim findings from PURPOSE 2 were presented last week at the HIV Research for Prevention (HIVR4P) conference in Lima, Peru.
The researchers compared the safety and efficacy of lenacapavir injections every six months to a daily HIV prevention pill – a combination of emtricitabine and tenofovir disoproxil fumarate, called F/TDF. The results have not yet been published in a peer reviewed journal, but is expected to be soon, according to Principal Investigator for PURPOSE 2 Dr Colleen Kelley, a professor of medicine at Emory University’s School of Medicine.
In the PURPOSE 1 study, none of the 2 134 people receiving the lenacapavir injection got HIV during the study. In PURPOSE 2, there were two HIV infections among the 2 179 people receiving the injection. These numbers are dramatically better than those for HIV prevention pills and for people in the communities where the study was done who were not receiving prevention injections or pills.
These findings mean the evidence is now in place for the manufacturer, Gilead Sciences, to file with regulatory authorities to register lenacapavir injections for HIV prevention. Such registration is required before the jab can be marketed for prevention. Lenacapavir injections are already registered in some countries as a last resort treatment for HIV, but not yet in South Africa.
“Now that we have a comprehensive dataset across multiple study populations, Gilead will work urgently with regulatory, government, public health and community partners to ensure that, if approved, we can deliver twice-yearly lenacapavir for PrEP worldwide, for all those who want or need PrEP,” Daniel O’Day, the chairperson and Chief Executive Officer of Gilead said in a press release. (PrEP, or pre-exposure prophylaxis, refers to taking antiretrovirals to prevent HIV infection.)
Top line findings
The interim results presented at HIVR4P by Kelley, showed that when compared to the background HIV incidence calculated in the study, lenacapavir reduced HIV infections by 96%. And when compared to the F/TDF prevention pill, the injection reduced HIV infections by 89%.
Among the 3 265 participants enrolled in the study, 11 people acquired HIV- two of the 2 179 people who were assigned to the lenacapavir arm and nine of the 1 086 participants assigned to the prevention pill arm. This translated to HIV incidence of 0.93 per 100 person years in the prevention pill arm compared to only 0.1 per 100 person years in the lenacapavir arm.
This was compared to the background incidence, which was determined when screening eligible participants for HIV. Out of 4 634 people screened for the study, 378 or 8.2% were diagnosed with HIV. Based on further laboratory testing, it was estimated that of those 378 people, 45 or 11.9% recently acquired HIV (classified as being within the last 120 days or so). This latter group provided the background HIV incidence, which was estimated to be 2.37 per 100 person years.
This is a novel study design, Kelley told Spotlight, because this calculation was used to estimate the HIV incidence that would have occurred in a placebo group without actually enrolling a placebo group.
“It’s no longer ethical to have a placebo group in HIV PrEP trials because we know that we have effective PrEP agents,” she said. “Yet, it’s almost essential to have a placebo group when you design a clinical trial so that you can really say how effective your medication, your new agent is [compared] to having nothing.”
When asked at a press conference about the two breakthrough infections in the lenacapavir arm, Kelley said the analysis for this is ongoing and will hopefully be available at a future conference and in a journal soon. She said that the two breakthrough infections in the lenacapavir arm were detected by routine testing during the study.
Principal Investigator for PURPOSE 2 Professor Colleen Kelley at the 5th HIV Research for Prevention Conference in Lima, Peru. (Photo: Nicole Bergman/IAS)
Kelley added that around 90% of participants in the two study arms were able to receive their injection on time. “So, we at least know that the injections were delivered in a timely fashion for almost all participants,” she said.
Whether or not the two infections occurred in people who had received the jabs on time and according to the study protocol will be closely watched as more study details is shared in the coming months.
To be enrolled in the study, participants had to meet several criteria. They had to be older than 16, never received HIV prevention injections before, weigh more than 35kg, have good kidney function, not have been tested for HIV in the last 12 weeks, and had to have been sexually active in the last 12 months.
All study participants were given a pill a day and an injection, those in the lenacapavir arm received two 1.5 ml lenacapavir injections every six months and a daily placebo pill, while those in the prevention pill arm received the daily F/TDF pill and a placebo injection every six months.
The study was conducted across seven countries, with 6 sites located in South Africa and others in Argentina, Brazil, Mexico, Peru, Thailand, and the United States, according to study data on Gilead’s website.
Safety data
Overall, Kelley said lenacapavir was safe and well-tolerated despite some side effects, mainly related to the injections. A total of 43 people dropped out of the study due to side effects.
The most common adverse event in the study was injection site reactions. There were more injection site reactions in the lenacapavir arm compared to the prevention pill arm. 29 people dropped out of the study because of these, 26 in the lenacapavir arm and 3 in the prevention pill arm (people in this study arm received placebo jabs).
The most common injection site reaction were subcutaneous nodules – these are harmless, usually invisible, small lumps under the skin. Nodules occur because lenacapavir is injected under the skin where it forms a drug depot. Injection site reactions and nodule size decreased with subsequent injections. This side effect and trend of decreasing reactions was also noted in the PURPOSE 1 study. Other injection site reactions were pain and erythema which is a type of skin rash.
According to Kelley, there were no serious adverse events related to injection site reactions.
When injection site reactions are excluded, according to Kelley, the other adverse events were similar across both arms, with 74% of participants in each arm experiencing an adverse event. The majority were mild or moderate.
Seven participants in each study arm dropped out due to side effects that weren’t related to injection site reactions. Those who discontinued from the lenacapavir arm will be given prevention pills for a year. This is done to protect these participants, Kelley explained, from potentially acquiring HIV when lenacapavir levels wane, as well as to reduce the risk of potential drug resistance developing.
There were a few serious adverse events, although Kelley told Spotlight she does not currently have any additional information on what these were. She explained that a serious adverse event is generally classified as something like hospitalisation, a life-threatening condition, an important medical event or adverse pregnancy outcome.
“Usually when we look at something like this, we look at the rates compared in the two arms of the study and it was 3% in the LEN [lenacapavir] arm and 4% in the F/TDF arm, so they were equal, essentially the same in both study arms,” Kelly said.
There were six deaths during the study, but none were related to the study drugs.
Next steps for lenacapavir
Now that the interim results have been announced, both studies have been unblinded and entered an open-label phase where participants have the choice of switching to or continuing with the injection.
Professor Linda-Gail Bekker, the Chief Executive Officer at the Desmond Tutu Health Foundation, recently said on a webinar hosted by the South African Health Technologies Advocacy Coalition, that study participants are now able to use the PrEP option they’d prefer – either oral PrEP or the injection. This means all participants will be able to access lenacapavir through the studies if they wanted to use it.
But it will likely be a while before anyone outside of these studies can access lenacapavir as HIV prevention.
“This is an incredible intervention. Now we have to make sure everyone can get it and that’s going to be the most important next step, ensuring that everyone who needs this drug has access,” Kelley told Spotlight.
Gilead’s generic licensing agreement and pricing
What we do know so far about the next steps for lenacapavir is that the process to allow for generic manufacturing has started. This month, Gilead released its voluntary licensing agreements with six generic companies for manufacturing cheaper versions of lenacapavir.
Dr Andrew Gray, a senior lecturer in Pharmacology at the University of KwaZulu-Natal, told Spotlight that no South African firms have been included in the voluntary licenses – four of the generic licensees are in India, one is in Pakistan, and one is in Egypt.
“In essence, they [the generic companies] are allowed to sell their generic versions in a number of identified countries, specified by Gilead,” Gray said. The agreement lists 120 countries, including South Africa.
Gilead itself will also be prioritising the registration of lenacapavir in 18 countries, which it said represent about 70% of the HIV burden in the countries named in the license. The list includes South Africa, Uganda, and Botswana. Gilead says it will start filing for registration with regulatory authorities by the end of the year.
It will be important to see how quickly Gilead seeks regulatory approval for lenacapavir with the South African Health Products Regulatory Authority (SAHPRA), Gray said. Registration with SAHPRA will be required before the injection can be rolled out in South Africa.
In putting together this timeline, we’ve spoken to several well-placed experts, but we stress that this is very much a back-of-the-envelope exercise and far from set in stone. (Infograph: Spotlight)
Some countries won’t be able to procure generics
Gilead received criticism for several omissions from the list of countries that the generic manufacturers can sell to. The US-based HIV advocacy group AIDS Vaccine Advocacy Coalition, among others, pointed out the exclusion of several countries which have high HIV incidence. Some of those countries participated in PURPOSE 2- namely Brazil, Argentina, Mexico and Peru.
A spokesperson from Gilead told Spotlight the manufacturer’s access policy included tailored approaches to ensure rapid and broad access of lenacapavir and it objectively considered the countries where a voluntary licence would provide the most benefit.
“Gilead’s voluntary licence primarily covers countries based on economic need and HIV burden, which are primarily low- and lower-middle income countries. The voluntary licence also covers certain middle-income countries with limited access to healthcare,” the spokesperson said.
Acknowledging that some middle-income countries do have a high HIV burden, Gilead is “exploring several innovative strategies to support access to LEN for PrEP (if approved), including tiered pricing, and are working with payors to establish fast, efficient pathways to help reach people who need or want PrEP”, said the spokesperson.
“Ensuring access in middle-income and upper-middle income countries, including those in Latin America, is a priority for Gilead. Planning for these countries, incorporating input from advocates and global health organizations, is ongoing and updates will be shared as discussions progress,” the spokesperson added. “Additionally, Gilead is committed to ensuring that individuals who participated in the PURPOSE studies have been offered and will be able to stay on open label lenacapavir until it is available in their country.”
The company’s decision to license generic manufacturers directly is at odds with earlier calls from several activist groups and UNAIDS to license via the UN-backed Medicines Patent Pool.
Pricing
It will also be important to see if Gilead will disclose a single exit price for the South African market, according to Gray.
In its press release announcing the voluntary licensing agreement, Gilead stated it will “support low-cost access to the drug in high-incidence, resource-limited countries through a two-part strategy: establishing a robust voluntary licensing program and planning to provide Gilead-supplied product at no profit to Gilead until generic manufacturers are able to fully support demand”.
It is too early in the process to reveal a price for lenacapavir yet, the spokesperson from Gilead told Spotlight.
“While Gilead prepares for global regulatory filings, it is too early to disclose the price of lenacapavir for HIV prevention. Our pledge is to price our medicines to reflect the value they deliver to people, patients, healthcare systems and society. For Gilead-branded lenacapavir, we do plan to price it at no profit to Gilead in 18 select high-incidence, resource-limited countries until generic manufacturers are able to fully support demand,” the spokesperson said.
Spotlight previously reported on research that estimated that if produced at sufficient volumes, the price of lenacapavir could be drastically reduced to levels likely considered affordable by the South African government. For instance, if enough volume was produced to supply 10 million people with PrEP, the price for the injection could be as low as $40 (under R800) per person per year. At the moment, Gilead supplies lenacapavir for HIV treatment in wealthy countries for about $40 000 per person per year.
Gilead’s lenacapavir product will be the first to register in South Africa and will almost certainly be the only lenacapavir product available here for several years – that is because it is expected to take generic manufacturers a few years before they can start producing generic lenacapavir. Based on calculations made for other PrEP products, it seems unlikely that the Department of Health would be willing to procure lenacapavir at a price significantly above R1 000 per person per year. The HIV prevention pill currently costs government around R800 per person per year.
The National Health Insurance Act does not deal with the systemic issues that cause high prices and inequity in medicine access, and government is not listening, argues Fatima Hassan.
As the department of health lunges forward with implementing a system of National Health Insurance (NHI), with business and other interests trying to thwart that, what lessons from the COVID-19 pandemic can help us to ensure health equity for all – for both users of the public and private health sectors?
A few key themes come to mind: market power, secrecy, transparency, accountability, timely access, and affordability.
COVID’s lessons
The human cost of COVID-19 globally was at least fourteen million people who died in just two years. In South Africa, COVID was the leading cause of death in 2020 and 2021, outstripping deaths due to other diseases in those years.
To mitigate the COVID pandemic and to move forward, we needed vaccines. Then, the creed of intellectual property fundamentalism preached to us by the ultra-wealthy and by pharmaceutical corporations was to tell us to monopolise and privatise the manufacture and supply of publicly created vaccines and medicines, while relying on voluntary market measures – not effective regulation or compulsory measures – to ensure access. That creed failed us.
At the time, agreements with private manufacturers for the supply of vaccines were entered into, and at the request of a very powerful industry, treated as a secret. The Health Justice Initiative (HJI) litigated to compel disclosure, and we won.
Our analysis showed a set of one-sided terms, including conditions that required Non-Disclosure Agreements with significant advance payments without legal obligations on suppliers in terms of delivery volumes or dates. The contracts provided sweeping indemnity terms, limits on international redistribution/donations, and overly broad intellectual property protections. We also found that in several instances, South Africa overpaid for vaccines compared to higher middle income countries.
Where we live
We live in a country with worsening health outcomes, a high burden of HIV and TB, and alarmingly high levels of gender-based violence.
Politically, we have had multiple health ministers in the space of just five years – even during a pandemic – due in part to corruption allegations and now, a new Government of National Unity (GNU). We have an unaccountable rotating door system for appointing ministers, deputy ministers, and health Portfolio Committee members, seriously blurring the Legislature’s oversight function. This is not good governance.
We have outstanding laws and regulations that could address some of the “now” issues but which are not being prioritised. For example, we are still subject to an apartheid-era Patent Law that is deferential to patent seekers, resulting in over patenting or evergreening. Vested interests, we believe, are blocking key amendments that would limit patent protection in favour of the public interest.
We do not have a robust local, properly state-subsidised health manufacturing industry in South Africa, often making us reliant on external manufacturers. We have xenophobia seeping into our health system, where patients have been attacked in state hospitals because of their nationality.
And on top of all of that, we have growing reports not just of provincial health product stockouts but also reports of widespread health sector tender corruption, and targeted assassinations of whistleblowers. Finally, given, among other things, our outdated patent system and inability to reign in medicine prices, our medicine costs are astronomical, needlessly (even when compared to other BRICS countries).
The NHI as the GNU’s test (and ours)
It is in this context, that even before the 2024 national elections, NHI has become a lightning rod of disagreement even within the GNU, including for business, creating a hostile climate for civic engagement. Sadly, the political gamesmanship over NHI especially at the Executive level, is coming across as unaccountable, arrogant, and non-engaging. This will not build our health system. In this debate, government has rarely admitted it made any mistakes so that is why it was surprising that in a recent Bhekisisa interview, the health minister conceded that restricting NHI basic health services (so non-emergency care) to South African ID holders may be self-defeating for public health. He said that that is a “mistake” that needs to be “rectified” in the NHI Act.
NHI and state-led procurement
The NHI Act envisages a single state procurement entity for all health products for NHI users (as selected by a benefits committee). In theory, this should provide greater negotiating power and leverage.
With the lessons of COVID and more recently Mpox, we can expect that may not be so. Even under NHI, there will be a scramble for much needed supplies, where South Africa will have to compete on the international market for often scarce and high priced supplies.
Thus, addressing the pharmaceutical industry’s power, and by virtue of that, the global and local medicine patent (reward) system and its abuse matters – but we need to do it now, not incrementally or at some later or undefined point.
For the NHI to financially sustain itself (and assuming here for a moment that it has sufficient funds to begin with), it will have to either overthrow or better regulate the current medicine over-patenting and pricing transparency system to survive, failing which, NHI money could dry up just on health products and medicine costs alone.
At present, South Africa on average pays more for medicines than comparator countries. Business is eerily silent about this aspect in its critique of NHI. Since medical schemes will continue to operate under NHI for some time, one would expect greater concern about the disproportionate use of scheme members’ resources in this respect too, from business.
On top of this, under an apartheid era drafted law (the Patents Act), South Africa is still also doling out patents allowing companies to evergreen their patents on several essential medicines including for TB and HIV, and cancer with limited regulatory and legal repercussions.
While the HJI vaccine procurement judgment should be having far-reaching implications, not just for the next set of pandemic procurement negotiations, but also for substantial state-led procurement due to take place under NHI, we would be naïve to think that the industry and powerful global and local actors in the pharmaceutical sector will change its ways for the better just because South Africa is implementing NHI.
The NHI, we are told, will be based on the principles of “universality and social solidarity” and will “unify” our health system. Yet, if we focus on just one aspect included in the Act – the medicine access system – it is a far cry from the promised system of unification. This is because it is drafted in a way that by our count and reading, creates at least four medicine access systems, operating in parallel (NHI for NHI users; Medical Schemes for scheme beneficiaries – while schemes are permitted to operate under NHI (could be decades); complementary cover via insurance coverage for NHI users; over the counter via out of pocket payments/insurance coverage for non-NHI users such as foreign workers, foreign students, resident non-nationals, etc.).
Either way, for all of its admirable “equity” intent, NHI in South Africa will be fully dependent on the global medicines access market whether we like it or not because we are not operating in a neutral, access friendly global system. Nor are we operating in a context where the executive has any real, public, and committed plan to drive down medicine prices before or while NHI is implemented – and without business interests interfering in the execution – it is leaving that totally to the market, to whimsical unenforceable donations and voluntary business conduct. That is not sustainable.
The President is fully aware of how the latter affected our vaccine access and procurement strategy and costs in the COVID-19 pandemic. What is he going to do about it?
NHI and “top-ups”
Under NHI, the Act will allow top-up products and complementary cover via insurance offerings to presumably fill the gap for those health products, services or medicines that the state may not select or include in the NHI Formulary because of affordability constraints. So how will those complementary cover products and medicines be priced and regulated? Will the current imperfect and expensive system, called the Single Exit Price System, for non-state medicines be used?
Imperfect, because in South Africa, public sector medicines prices are largely determined by the bids companies submit in response to advertised government tenders. In the private sector, companies are free to launch a medicine at any price, although once launched, annual price increases are regulated – so that every drug in the private sector has a single exit price. In rare cases, excessively high medicine prices have been challenged using competition law, but this is the exception.
There have been moves toward reference pricing – where maximum prices for specific medicines would be determined by reference to prices for that medicine in a basket of other comparable countries – but none of several rounds of regulations proposing such a system have been implemented, mainly because pharmaceutical companies usually litigate against the state to prevent it from implementing such a comparator system – in other words, like elsewhere, while we face exorbitant medicine costs, we also face powerful corporate lobbies that do not want proper transparent systems for setting medicines prices. This only serves a profiteering agenda.
NHI and medicine access questions
Just on the narrow point of medicine access under NHI there are critical issues that need to be clarified. They include the following:
Whether we can be guaranteed transparency and information, including about the deliberations of the various NHI ministerial advisory, benefit and selection committees, and procurement structures under the NHI – or will we have to litigate every access to information request, as we did in COVID?
How will the NHI Fund (Office of Health Products Procurement) negotiate with the global pharmaceutical industry without, for example, the bullying we witnessed in the COVID-19 pandemic?
And specifically for medicines and health products:
Will manufacturers be permitted to sell to health providers other than the state? If so, how will this be done, and how will the maximum price be determined or regulated?
Which medicines and health products will be covered under NHI benefits as part of the NHI Formulary and how will the price of those not covered (top-ups/complementary cover) be regulated?
What role will the current private sector pricing system play including the single exit price system – and how and when will it be amended?
As our country pushes ahead with the NHI, there are some immediate concerns like these that we believe will affect implementation.
Of course, we all support the vision of a unified, equitable health system. But aspirations aside, the NHI Act does not deal with the systemic issues that cause high prices and inequity in access. Instead of investing effort into systems that control prices better at the outset, it is investing in systems to deal with the consequences of unaffordable drugs, hoping for self-correction, all while deferring to powerful vested interests including business lobbies that have the President on speed dial.
Regulatory bodies and civil society actors can only take on the tip of the medicine pricing iceberg – the question to the President is, while the Executive dithers on amending keys laws including the Patents Act, under NHI: who exactly will fight for every single patient and for every single medicine?
Since the NHI Bill was signed into law, the President (and his Cabinet) are now duty bound to take constitutional steps to remedy the deficiencies in the NHI Act, and at the very least, to listen to all sectors, not just business.
*Hassan is director of the Health Justice Initiative. This piece is drawn from her key note address at the 2024 Annual David Sanders Lecture in Public Health and Social Justice hosted by the University of Western Cape’s School of Public Health and Peoples Health Movement South Africa.
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.
The South African Health Products Regulatory Authority (SAHPRA) and the Australian Therapeutic Goods Administration (TGA) have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health product regulators.
The MoU builds on the existing relationship between the health products regulators to improve capabilities in the assessment of medical products and therapeutic goods and their monitoring for continued efficacy, safety and quality once they are registered.
Areas of cooperation
SAHPRA and TGA will engage in data sharing aimed at improving the regulatory functions executed by both regulators. This will particularly focus on the assessment and approval of medical products and therapeutic goods, their monitoring for continued efficacy, and the surveillance for safety and adverse reaction (event) concerns.
According to SAHPRA’s Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, the agreement with the TGA expands the geographical reach for both regulators’ pharmacovigilance programmes and augments their internal expertise.
“This partnership enables us to rely on each other’s strengths and regulatory outputs in the evaluation of health products both before they are registered and once they are approved for public use. This would improve therapeutic outcomes for the populations we exist for and increase the robustness of our post-registration surveillance for efficacy, safety and quality,” says Dr Semete-Makokotlela.
Deputy Secretary at the Australian Government Department of Health and Aged Care and head of the TGA, Professor Anthony Lawler, said: “TGA is very pleased to have strengthened our collaborative relationship with SAHPRA with the signing of this international agreement. We look forward to working alongside our regulatory counterparts in South Africa to share important regulatory information to ensure the continued safety, quality and efficacy of therapeutic products approved for market.”
The idea of mandatory medical scheme coverage for employed people has made a comeback after the case for it was made at a recent conference. The policy move was previously on the cards in South Africa but faded after the ANC opted for National Health Insurance (NHI) at its 2007 national congress where Jacob Zuma was elected as the party’s new leader. Chris Bateman unpacks how a system with mandatory medical scheme membership for the employed might work and asked local experts whether it represents a viable alternative to government’s NHI plans.
A vigorous public debate has ensued since outgoing Netcare CEO, Dr Richard Friedland, on behalf of the Hospital Association of South Africa (HASA) delivered a strongly argued case for a return to what he described as the original ANC healthcare plan. He was speaking on “Viable and Near-term Opportunities to Providing Enhanced Healthcare in South Africa,” at HASA’s annual conference in Sandton held early in September.
Since then, the leadership of Business Unity SA (BUSA) met with President Cyril Ramaphosa and Health Minister Dr Aaron Motsoaledi, and his deputy and other senior officials, in mid-September to discuss “matters of concern” related to the NHI. The President requested BUSA to put forward specific proposals on “the remaining matters of concern” as a basis for re-engagement.
Some observers have suggested to Spotlight that these consultations are a first sign of government openness to changing or tweaking its NHI plans. But whether this means the door is actually open for a system of mandatory health insurance, or for mandatory health insurance as a stepping-stone toward NHI, is still unclear.
The NHI Act, that was signed into law by Ramaphosa in May, envisages a single-payer system where medical schemes are only allowed to cover health services that are not covered by the NHI fund.
How mandatory health insurance would work
Under mandatory health insurance, everyone who is in formal employment, or who earns above a certain threshold, would be forced by law to be a member of a medical scheme. This will result in medical scheme membership swelling substantially and some pressure being taken off the public healthcare system. It is also expected to result in medical scheme premiums being reduced because more healthy, younger people will join the schemes. People who are unemployed or who cannot afford health insurance will still be dependent on the public healthcare system.
Friedland said such mandatory healthcare insurance will triple the medical scheme market from 9.2 million to potentially 27.5 million beneficiaries over time and reduce those dependent on the state from 53.8 million to 35.5 million. In so doing, it would boost public healthcare per capita spending by 52%, (from R5 054 to R7 659), without any additional funding of the public sector budget, alleviate the strain on public hospitals and clinics, shorten waiting lists, and free up money to hire more staff and improve infrastructure. He said it is a “far faster and more efficient tool” for achieving health equity.
Responding to the counter argument that a mandatory health insurance system would entrench existing health inequalities, Professor Alex van den Heever, Chair of Social Security Systems Administration and Management Studies at the University of the Witwatersrand, said the opposite is true. “It accelerates convergence between the two systems faster than the NHI proposals,” he told Spotlight.
The relief for people who can afford medical scheme cover could also be significant. Friedland said mandatory medical scheme membership would bring more young and healthy people into the system, thus reducing the cost of monthly premiums by 25% to 30%.
Mandatory contribution schemes for civil servants have been implemented in more than half of the countries in Africa, while Thailand and many other Asian countries have started with mandatory cover for the formal sector before expanding to the non-formal sector. Such systems with what amounts to many medical schemes, rather than a single large fund, are also in place in several European countries, including the Netherlands and Germany.
Not a new idea
Mandatory health insurance, or an expanded role for medical schemes, are by no means new ideas in South Africa. Friedland told Spotlight that the ANC government’s own broad ranging 2002 inquiry into the various social security aspects of the South African health system concluded that national health insurance or the complete nationalisation of the private sector, could not be seriously considered as a reasonable option. (The inquiry itself was based on the Health Subcommittee Findings of the Committee of Inquiry into a Comprehensive System of Social Security.)
That 2002 report concluded: “National health insurance is not an option that emerges overnight as an alternative to social health insurance. Instead, it becomes feasible within market economies where formal employment levels are high. Prior to this, mixed systems are inevitable.”
One indication of how committed government was to such a mixed system with an expanded role for medical schemes in the early and mid-2000s, is the fact that the legislative framework to enable the expansion of medical scheme coverage was incorporated into the 2008 Medical Schemes Amendment Bill. That bill did not go as far as making scheme membership mandatory, but a mandatory system was clearly a next step on the reform agenda, as outlined in the very wide-ranging 2002 Taylor report on social security in South Africa. But presumably because of the NHI proposals, the 2008 amendments were allowed to lapse – and the scaffolding for a progressive expansion of medical scheme coverage collapsed.
There have since been several committees of inquiry and technical processes that validated an ongoing role for medical schemes, of which the Competition Commission’s Health Market Inquiry (HMI), that ran for five years (2014 to 2019), was the most technically detailed, consultative and authoritative. The HMI report did not recommend that medical scheme membership be made mandatory for people who are employed, but it did recommend a continued role for medical schemes and suggested that the most viable path to NHI may well involve first fixing the regulation of medical schemes.
Van den Heever said South Africa needs to quickly return to the pre-2008 reform trajectory to help stabilise the health system, “before more harm is done”. Government needs to summon up the political will to address the systemic governance failures of the public health system, removing the “bad actors and provincial cabals” that were destroying the integrity of South Africa’s free public health services, he added.
Better regulation also needed
For a system of mandatory health insurance to work, medical schemes will have to be more effectively regulated. Here the HMI report found that government had dropped the ball. It attributed the private health market failure and rampant medical inflation directly to government neglecting to regulate the private healthcare industry.
Health actuarial consultant, Barry Childs, joint CEO of Insight Actuaries and Consultants, told Spotlight private healthcare sector reforms urged by the HMI were ignored, resulting in ongoing confusion, high costs, complicated products and waste, among other problems. “Our incomplete medical scheme regulation keeps costs up, (for example anti selection, Prescribed Minimum Benefits), with benefits out of reach of most. We still don’t have a proper framework for lower cost-lower benefit products for those who cannot afford medical schemes,” he said.
The HMI report recommended a framework that went “way beyond naïve approaches to price control”, said Van den Heever, and addressed the powerful incentive structures driving unproductive forms of competition. In addition, he said, the industry-wide pooling approaches (risk equalisation and social reinsurance) followed international best practice and fully addressed issues of pooling fragmentation.
In the five years since the publication of the Commission’s HMI report, none of its major recommendations have been implemented.
Jobs and taxes
One common thread running back to the 2002 report, is the idea that South Africa is not economically ready for NHI and that a mixed system, possibly with mandatory health insurance, is more compatible with the current realities of high unemployment and a relatively small tax base.
“The root cause of inequity and inequality is not just a new form of apartheid. The real reason is the catastrophic level of unemployment. Until we address that, we will not solve an entire range of inequities, including food security, housing, education, and healthcare,” said Friedland.
On joblessness, Childs said South Africa was on track with the rest of the world’s growth up to 2008 but thereafter flat lined for over a decade. “We have dramatically underperformed the rest of the world and our peer group of middle-income countries in long term economic growth.”
In South Africa, unemployment is at an extremely high 33.5%, while in 2002 it was at 26%.
“If an NHI was unaffordable in 2002, how much more so is it today?” Friedland asked. He said that in this context, strong partnership, collaboration, and co-operation between the public and private sector is needed to bridge the polarisation that has arisen.
Analysis commissioned by BUSA found that raising the extra R200bn the health department says it needs to fund NHI would entail unrealistic and unaffordable tax hikes. It would either increase personal income tax by 31%, push VAT from 15% to 21.5%, or require the collection of a payroll tax of R1 565 per month from everyone in formal employment.
Van den Heever said that while government has a discretion to increase tax rates to any level it chooses, it cannot control the resulting amount of funds raised. He said that once tax capacity is reached, a hard ceiling on government revenue results at any given level of economic growth. The only way to grow revenues thereafter is through economic growth, failing which, revenues stagnate beyond government control.
The “big idea”, he said, was that new taxes would fund the move of medical scheme members to the public sector, in the form of a single NHI Fund, such that both public sector and medical scheme populations were covered in the same system – with net gains in coverage for both.
However, contrary to what was “correctly understood” from 1994 to the 2002 Taylor Commission, “the maths for such an approach, just does not add up”, said Van den Heever.
“The fastest way to de-segment the system is to allocate all new government revenues arising from economic growth to the people who need it most. This is not what the NHI proposals envisage. They want to dilute the public spend by trying to cover higher income groups. It is dangerous magical thinking that allows government to avoid dealing with the complex problems of the health system. Government needs to get back to its day job and do the heavy lifting needed to get our health system working again.”
Government response
Spotlight shared an earlier draft of this article with the National Department of Health for comment. While the department did not comment directly on mandatory health insurance, Foster Mohale, the department’s Director of Communications, emphatically reiterated their support for NHI and the NHI Act that was signed into law in May.
“There is no better time than now to reform South Africa’s health system. It is time to do away with the apartheid type of health system, and to reconfigure it into one that ensures that every South African gets the health care that they need, when they need, where they need and without incurring financial hardship. With the enactment of the NHI Act, the time for piecemeal approaches that retain benefits for the few and leave the majority to the whims of the market is no more,” Mohale told Spotlight.
He said that many countries, including Japan and the United Kingdom, have implemented health system reforms directed at achieving universal health coverage during times of crisis and low economic growth. “Therefore, to say that South Africa must sit and wait for some oracle numbers to emerge before instituting NHI is merely to argue that we must consciously let those that are carving profits and dividends from the anomalies that characterise our health system to continue. This is an irresponsible position that the Department cannot adopt as health is a constitutionally enshrined right for every South African, not just a privileged few,” he said.
On the questions of taxes, Mohale said: “We will not delve into the projected tax implications because we believe this is a matter that squarely falls under the purview of the National Treasury and the Minister of Finance. Suffice to say at the right time, and after necessary deliberations through formal government structures and processes, any information relating to this will be communicated to the public for comments prior to finalisation.”
Note: The 2002 Tailor report titled ‘Transforming the present – Protecting the future’ is not readily available online. There is this PDF version (unfortunately not searchable and with poor accessibility). For ease of use, we have created a Word version of the document that you can access here. Health is discussed in chapter 8.
Northern Cape Premier Dr Zamani Saul is tasked with appointing heads of department in the province. (Photo: Northern Cape Provincial Government/Twitter/X)
By Refilwe Machoari and Adiel Ismail
The Northern Cape health department has had several heads of department in the last five years. Spotlight unpacks the implications of this leadership instability and asks what it means for good governance in the public health sector.
The Northern Cape health department has seen a fast-revolving door of heads of department (HODs) in the last five years, with one person being at the helm for a mere two months.
This is because the two people to hold the powerful post permanently are dogged by claims of alleged financial transgressions and corruption. The health HOD position is one of the most multiplex jobs in provincial government with oversight of what is typically one of the two largest lines of provincial budgets.
At R20 billion over the next three years, the health department got a massive slice of the Northern Cape’s R68.1 billion budget for the period. By contrast, over the same period, R6 billion was allocated to the Department of Roads and Public Works, R3.1 billion to the Department of Social Development, R1.3 billion to the Department of Sport, Arts and Culture and R1.1 billion to the Provincial Treasury.
Financial management
While the National Department of Health leads on health policy, the implementation of policy and the day-to-day running of public healthcare services is managed by provincial departments of health. As the accounting officers in provincial health departments, HODs play a crucial role when it comes to proper accounting and financial management.
Compliance to regulatory frameworks and standards though are lacking according to the latest Northern Cape Department of Health annual report. It shows that the department incurred irregular expenditures of more than R144 million in the 2022/2023 financial year. The department also incurred fruitless and wasteful expenditures of almost R15 million in 2022/23 compared to R13 million in the previous year.
The department received a qualified audit opinion. This means that the financial statements contained material misstatements or there is insufficient evidence to conclude that amounts included in the financial statements are not materially misstated.
The auditor-general wrote: “I was unable to obtain sufficient appropriate audit evidence that public money was spent with the approval of a properly delegated officer”, that the financial statements “submitted for auditing were not prepared in accordance with the prescribed financial reporting framework and supported by full and proper records”, “effective and appropriate steps were not taken to prevent irregular expenditure”, and “effective steps were not taken to prevent fruitless and wasteful expenditure”.
The auditor-general’s qualified audit opinion reflects on leadership and practices in the department, and is reputational damage with a growing trust deficit with communities it serves, Dr Beth Engelbrecht, former HOD of the Western Cape Department of Health, told Spotlight.
“Health is one of the most complex departments with the largest budget, compared to other 12 provincial departments. This includes the largest budget of all for goods and services, which must be purchased from private providers. This reality brings complexity in the management of its finances within all the rules and regulations, but also makes it prone to those who wish to do corruption,” said Engelbrecht.
Indeed, this appears to be the quandary facing the office of the health HOD in the Northern Cape. Two HODs have been arrested over alleged corrupt dealings or contravention of the Public Finance Management Act (PFMA).
A brief history of HODs
In 2020, then health head Dr Steven Jonkers was charged with contravening provisions of the PFMA. It is alleged he concluded a multi-million rand contract in 2017 without following the correct procurement processes. Jonkers declined to comment on this case, which is set to be back in the Northern Cape High Court in Kimberley in November. Premier Dr Zamani Saul has seconded Jonkers as a deputy director-general in the Office of the Premier since 2020.
The head of health position was then filled by a string of people acting in the role, including Dr Deon Theys who would also have a brush with the law. Despite this, Saul appointed Theys as the new health head on a fixed five-year contract in July 2023.
But a month later, the Specialised Commercial Crimes Court in Kimberley found Theys guilty of not following proper PFMA prescripts and procurement processes. It related to R13 million in lease deals which he signed between 2011 and 2012 while he was the acting HOD. Theys was sentenced to a fine of R150 000 or three years imprisonment, of which R100 000 or two years imprisonment is suspended for five years, on condition that he is not found guilty of the same offence during the time of suspension. Theys is appealing this court ruling and declined to comment on the matter.
Theys’ problems is far from over. In a separate court matter, along with other senior public servants, he is facing charges in relation to a multi-million rand tender for the procurement of Covid-19 equipment.
He will be appearing in the Kimberley Magistrate Court in October on charges of fraud, corruption and contravening the PFMA. This was confirmed to Spotlight by the spokesperson for the National Prosecuting Authority in the Northern Cape, Mojalefa Senokoatsane.
With these new charges hanging over his head, Saul has since redeployed Theys to the position of provincial medical director – a post he held previously.
‘Saving money’
Without responding to detailed questions from Spotlight, the Premier’s spokesperson Bronwyn Thomas-Abraham said Theys’ role as medical director is helping to save the health department money.
“This decision was taken mindful of Dr Theys’ experience and served to save costs in appointing another Medical Director,” she said.
Thomas-Abraham noted that any “course of action” against Theys hinges on the outcome of his appeal. It would therefore appear that Theys’ appeal stalled the necessary formal internal inquiry that should follow, according to the Senior Management Service Handbook, within 60 days after he was transferred as a precautionary measure.
She also dismissed concerns that appointing acting health heads could negatively impact the department’s operations, insisting that service delivery remains unaffected.
“The appointment of an Acting Head of the Department did not have any adverse effect on the Department’s operations as it receives additional Financial Management and Human Resource support from the Provincial Treasury and Office of the Premier respectively,” Thomas-Abraham said.
Acting HODs
Having acting HODs is clearly not the way governance is generally supposed to work. For example, according to the Public Service Act and the Public Service Regulations, an official may not be in an acting position for more than 12 months.
Dr Alastair Kantani was appointed as acting head of the Northern Cape health department in September 2023, followed by Mxolisi Mlatha who has been acting in the role since December 2023.
“Whilst people in acting positions have the legal authority to take decisions and be accountable for these, they lack the required power to be transformational and bring changes that will improve delivery and functioning. Their authority when negotiating for funds are limited compared to appointed full time HODs,” said Engelbrecht.
She added: “Even communities view these acting persons not with the same regard as fully appointed leaders. Staff may also view an acting person of having less power, making it more difficult to bring coherence and alignment in a department.”
And it is precisely this that has led to protest action by workers affiliated to Nehawu, Denosa and Cosatu who took to the streets on 2 August, demanding that Mlatha step down and that a clinician with a medical background serve as HOD.
‘Negative impact’
Speaking to Spotlight, Nehawu provincial secretary Moleme Moleme said the continuous change of health heads has a negative impact on workers. “In many ways it has an impact on the direction that the department wants to take. It also places uncertainty on members which leads to low staff morale.”
Moleme said that the Premier needs to be decisive by bringing stability into the health department. “The corrupt-centric, crises ridden and unstable provincial department of health is unlikely to change its course from the sixth to the seventh administration because it is led by the same individuals who has landed the department into a crisis where it is at the brink of collapse,” he added.
Spotlight previously reported on the dire state of the healthcare system of the country’s largest, but most sparsely populated province. During an oversight visit last year, the Northern Cape’s Director-General, Justice Bekebeke told MPs on Parliament’s Portfolio Committee on Public Service and Administration that the health department is among the worst-performing when it comes to frontline services, disciplinary cases, payment to creditors, and leadership instability.
The DA leader in the Northern Cape, Harold McGluwa, said the health department faces a laundry list of challenges, including surgery backlogs, medicine stockouts and flailing emergency medical services hampered by a lack of operational ambulances.
He told Spotlight that his party, which is the official opposition in the legislature, is not prepared to endure a repeat of the sixth administration under the ANC, which lost its outright majority in the province in the May general election.
The DA therefore wants Public Service and Administration Minister Inkosi Mzamo Buthelezi – an IFP member serving in the government of national unity – to step in to bring stability to the office of the HOD.
“The department is in critical need of stability and that can only come with stable management and firm decision-making of a fixed-term appointee to the position of HOD,” said McGluwa.
Corruption concerns
The EFF ‘s provincial secretary in the Northern Cape, Zen Kwinana, claimed the health head post with its huge budget responsibilities is being “abused for corruption” and to “accumulate personal wealth”.
“Saul will not appoint an HOD because he wants to control the position, and they also want the acting individual to entirely depend on their mercy,” he alleged. “Unfortunately amidst all of this, it is the people who suffer the most, services are poor, there is a shortage of medication and the infrastructure at hospitals and clinics are in a dire state,” added Kwinana.
To address corruption, co-authors of the report Professor Lilian Dudley and Professor Sharon Fonn told Spotlight urgent steps are required to prevent as well as to mitigate it. And where corruption has occurred, they say clear, visible and swift action is needed to charge and penalise managers and employees involved. “To do this, the health system needs to work closely with the various role-players in the criminal justice system and groups such as the Health Sector Anti-Corruption Forum.”
Dr Aslam Dasoo, convener of advocacy group Progressive Health Forum, is scathing of political leaders and public servants abusing their office for nefarious means.
“What you’ve got is a budget and people with an eye on the budget, and they will do everything they can to purloin as much of it as they can for personal use… that is what this is about, that is why you have this merry-go-round of appointments and acting appointments.
“Why do they keep these guys still in their jobs, or redeploy them somewhere else when they are under scrutiny? It is because they [appointees] are under scrutiny, they can’t have these guys thrown to the wolves, they put them there, that is the simple answer. It has got nothing to do with healthcare and health policy,” he told Spotlight.
‘Difficult decisions’
Political analyst Dr Ina Gouws said political infightings, factionalism, and interference are the biggest factors that hammer the filling of critical government positions and it is a matter the ANC has grappled with for many years.
She said being a leader requires one to make difficult decisions regardless of what the political situation looks like.
“This situation is not beyond the control of the Premier. He cannot say that there are no capable candidates, because that would be a lie. There are many qualified people who can fill this position, but it is the political interference that is standing in his way of appointing a credible candidate,” said Gouws.
The health department is not the only Northern Cape department impacted.
The education department, which was allocated the biggest budget in the province at R25.3 billion over the next three years, has an acting HOD. The agriculture department with a much smaller budget of R2.3 billion also has an acting HOD. The premier’s office told Spotlight that advertisements for both positions have been placed and processes related to recruitment are underway.
And another department’s HOD is also in the crosshairs of law enforcement authorities.
Dr Johnny MacKay, the HOD of the Department of Public Works and Infrastructure, is facing 271 charges of contravening the Pension Funds Act involving an amount of R9 million. Asked for comment, the department’s spokesperson Zandisile Luphahla said the HOD cannot comment on the matter because it is before the courts.
It is alleged by the Hawks that between September 2021 and March 2022, while he served as the Acting Municipal Manager of Kai !Garib, MacKay failed to ensure that contributions deducted from municipal employees were paid to the consolidated Retirement Fund for Local Government. This matter will be in court in November for trial, Senokoatsane told Spotlight.
Saul has not acted against MacKay who is still in his HOD post.
The right people in the right positions
Dudley and Fonn stressed that the current instability, with many provinces still having acting HODs, allows greater political interference which undermines good governance and leadership within provinces.
They said in the public health sector, the right people must be in the right positions, with the right capacity to do what needs to be done. “Politicians need to be held accountable to appoint appropriately competent and ethical HOD’s, and to support them in their mandates.”
Engelbrecht added that appointing strong accountable and good character leaders should not be directed by politics, but by capability and people who are fit for purpose.
“The health HOD has one of the most complex jobs in government and often must deal with political pressure especially due to the large goods and services budget to its avail,” she said. “The HOD therefore must be of good character with ethical leadership capabilities, well versed into health, with humility to lead and be visible across the whole service to be able to unblock blockages and support staff who must work under difficult circumstances.”
To do this, Engelbrecht said, the HOD needs to build a strong team around him or her as well as across the layers in the system, with accountability mechanisms that happens in an enabling environment, where staff are allowed to innovate and feel supported in their work.
“Whilst health is a political matter, it is more a matter of social justice. The HOD should have the dedication and capability to stretch the health rand to do the greatest good to the greatest number and prioritise the vulnerable.”
Craig Comrie, chairperson of the Health Funders Association
Wednesday, 25 September 2024, The passage of the National Health Insurance (NHI) Bill into an Act of law has set the stage for one of the most significant overhauls of South Africa’s healthcare system. As the government embarks on this ambitious plan, the stakes have never been higher. The NHI Act is more than a mere piece of legislation; it stands as a test of constitutional rights and the nation’s commitment to fostering a more inclusive and equitable society.
The Health Funders Association (HFA) welcomes the meeting between President Cyril Ramaphosa and Business Unity South Africa (BUSA) leadership on Tuesday, 17 September, to discuss the NHI as a positive step.
As a member of BUSA, we find it encouraging that the Minister and Deputy Minister of Health, along with other senior officials, were part of this constructive and forward-looking discussion. We can only hope that these recent discussions will mark the start of a series of engagements with key stakeholders, as the South African government must engage in open dialogue with all stakeholders, including private healthcare providers, medical schemes, and the general public. HFA will provide industry input to BUSA’s presentation to the President to help propose workable solutions to set South Africa’s healthcare train on the right track with inclusive mechanisms that will benefit all.
Constitutional rights and freedom of choice
The critical questions about the Act’s constitutional validity, economic feasibility, and potential impact on both public and private healthcare sectors, specifically the role of medical schemes, remain unanswered.
Recently, during a Q&A session, the President reaffirmed his belief that the Act is constitutionally sound but he declined to share specifics on how this conclusion was reached. In response, the Health Funders Association (HFA) will test various aspects of the NHI’s constitutionality, which is crucial for establishing a stable healthcare framework that delivers quality health services for all South Africans.
This is a critical juncture for politicians, policymakers and every South African who relies on the nation’s healthcare services – private and public sectors alike. Against this background, the HFA is seeking to strike a balance between much-needed healthcare reforms and the hard-hitting risks of the NHI Act that demand amendments.
Government has been adamant about the NHI’s transformative potential to address inequalities in healthcare access, contending that the NHI is aligned with Section 27(1) of the Constitution, which guarantees the right to access healthcare services, including reproductive healthcare.
On the other hand, this part of the Act cannot be read without the consideration of Section 36 which indicates that existing rights should not be compromised if there are alternative ways to achieve, in this case, universal health coverage. This is a key part of responding to the President’s invitation for alternative proposals that stand a more realistic chance of achieving a partnership with the private sector for improving healthcare for consumers.
Any alternative proposals provided by the private sector will come with the need to amend the current. The Act, if left unchallenged in its current form, can be likened to letting the healthcare train run on a single track of public sector inefficiency. By adding the private sector as a parallel track – both heading in the same direction towards universal healthcare coverage, we can stabilise and accelerate the journey.
The medical scheme sector effectively provides funding to the majority of services in the private sector with less than 10% of health consumers paying for services out of pocket in the private sector. This population group serves a significant portion of the taxpaying population, yet its role in the new system remains ambiguous. Will private healthcare consumers be forced to rely solely on centrally procured services, or will there be room for a coexistence that stands a better chance of laying the track towards a successful healthcare future that can benefit all South Africans?
Transparency and collaboration are essential in addressing the questions surrounding the NHI’s financial viability, human resource capacity, and broader economic impact. The future of South Africa’s healthcare system hinges on finding a balanced approach that ensures quality, accessibility, and economic sustainability for all citizens.
The government proposes funding the NHI through general taxes and mandatory payroll contributions. However, this plan has been met with scepticism as it raises considerable questions about the economic burden on taxpayers, particularly given the country’s high unemployment rate of 33.5% and sluggish economic growth rates of around 0.4% in the second quarter of this year. Critics argue that increasing tax rates to fund the NHI could backfire, reducing overall tax revenue, as highlighted by the Laffer Curve, which suggests that higher taxes can lead to lower revenue if they exceed an optimal rate.
Where will the healthcare professionals come from?
The public healthcare sector faces its own set of challenges. Reports indicate that the quality of care in public health facilities is often subpar, with systemic inefficiencies and resource constraints leading to poor health outcomes. The sector is grappling with high vacancy rates for healthcare professionals, exacerbating the strain on an already overburdened system. As it is, South Africa is already facing a severe shortage of medical personnel, with the vacancy rate for doctors ranging from 22.4% in the Free State to 5.5% in the Western Cape, while the national average vacancy rate for nurses stands at 14.7%.
The current system is struggling to fill thousands of vacancies for doctors, nurses and allied healthcare professionals, with over 2 000 unfunded vacant posts for medical doctors across nine provinces requiring an estimated R2.4 billion to fill them. Many provinces report alarming doctor vacancy rates: 18.5% in Mpumalanga, 17.6% in Limpopo, and 11.3% in KwaZulu-Natal, among others. The shortage is not just a numbers game; it affects the quality of healthcare that can be delivered. These figures raise serious concerns about the system’s capacity to deliver reliable and accessible healthcare services hampered by corruption and lack of proper leadership and management.
We must consider the strain this places on those simply trying to cope with the current healthcare demand from a growing population. The NHI aims to provide universal health coverage, but where will the necessary healthcare professionals come from?
The way forward
The NHI is not the only solution to South Africa’s healthcare challenges and is certainly not a panacea in its current form. The government must take a more collaborative approach, engaging with all stakeholders, including the private healthcare sector, medical schemes and the general public. Open dialogue is crucial to finding sustainable solutions that work for everyone. Critical decisions must be made, and these should not be taken behind closed doors. The nation’s healthcare needs are too important to be dictated by a select few without broader consultation.
The government has a constitutional obligation to ensure every South African has access to quality healthcare services. However, this must not come at the expense of freedom of choice, job losses and economic stability.
I urge President Cyril Ramaphosa to protect the constitutional rights of all South Africans and engage in meaningful dialogue with all stakeholders. The future of South Africa’s healthcare system depends on our collective ability to find innovative and inclusive solutions.
