Pretoria, 8 January 2026 – The South African Health Products Regulatory Authority (SAHPRA) has been made aware of products in the market containing Zinc picolinate (as a source material for zinc) and/or Selenium intended for use in children.
The safety concerns related to children are as follows:
Zinc picolinate, at any supplemental dose, can cause side effects which include indigestion, diarrhoea, headache, nausea, and vomiting. As the bio-availability of Zn from Zn-picolinate is variable due to multiple factors, the risk of side effects may be higher and unpredictable, and it is unsuitable as a source of elemental zinc supplementation in children; and
Selenium, when supplemented to children, represents a safety concern considering the potential differences in selenium daily intake between different population groups. While selenium intake is a viable requirement for children in areas of famine or dietary restriction, the potential adverse effects of selenium overdose are of concern when provided in general supplements/medicines intended for children.
The products currently on the market are marketed and sold, among others, as “Immune boosters” for children, with the main active ingredients being Zinc (when derived from Zinc picolinate) and/or Selenium intended for use in children. These products are indicated for supporting the treatment of colds, flu, diarrhoea, and skin-related conditions, rendering the products in question medicines that require registration by SAHPRA.
Any medicine sold that contains Zinc picolinate or Selenium intended for use in children does not qualify as a Category D (complementary) medicine. As such, their sale as a Category D medicine is illegal. Therefore, with effect from the date of publication of this notice, all selenium and zinc picolinate-containing products intended for use in children shall be subject to registration as a medicine falling into Category A, as defined in Section 14(2) of the Medicines and Related Substances Act, 101 of 1965, and need to be submitted to SAHPRA for registration. The sale of Category D (complementary) medicines containing Zinc picolinate or Selenium and intended for use in children must be withdrawn from the market within six (6) months of the date of this publication.
Advice for health professionals and distributors:
SAHPRA requests that Health professionals cease all distribution, selling, and/or dispensing and remove all selenium and zinc picolinate-containing products intended for use in children from stores, storage facilities, and shelves.
Members of the public are urged to return products containing Zinc Picolinate and Selenium when intended for use in children, to their pharmacist, supplying warehouse, or distributor.
Reporting side effects
Public and healthcare professionals are encouraged to report any side effects after using a health product by using the Med Safety App. Your report will contribute to our monitoring of these health products.
NHS doctors are going on strike just as the UK is facing a surge in cases of “superflu”, which would have by itself placed an even greater burden than the public health service usually faces this time of year as services are stretched thin.
According to The Guardian, this is the 14th such action since disputes over junior doctors’ pay and jobs began in March 2023. Since then, they have won the right to be called “resident doctors” in line with the US because the British Medical Association (BMA) felt that the previous term was demeaning and misleading.
Resentment between government and doctors grows
After the government’s last offer was rejected, BMA members voted in an online ballot 84% in favour of industrial action. UK Prime Minister Keir Starmer called the walkouts “irresponsible” amid a surge in super-flu cases. Meanwhile, the UK’s Secretary of State for Health and Social Care, Wes Streeting, asked junior doctors to ignore the BMA and show up for work. He dismissed the resident doctors’ 26% pay claim as a “fantasy demand”, and has also said that the strike could be “the Jenga piece” that finally brings about the collapse of the NHS just when it is needed the most.
The strike will begin on Wednesday 17th December at 7am and will continue until the following Monday at 7am.
The magnitude of the problem has echoes of South Africa’s own struggles to find training placements – but at a far larger scale. Some 30 000 newly graduated doctors are having to compete for around 10 000 training posts. Even the government’s best offer could only add 2000 extra jobs.
Dr Jack Fletcher, the chair of the BMA’s resident doctors committee, said: “There are no new jobs in this offer. He has simply cannibalised those jobs which already existed for the sake of ‘new’ jobs on paper. Neither was there anything on what Mr Streeting has said is a journey to restoring our pay – that has clearly hit the buffers.”
Is ‘superflu’ even real?
Experts have however cast doubt on the UK government’s narrative of a dangerous new influenza mutation a “superflu”. Mathematician Christina Pagel, University College London professor, said that the “superflu” term was based on “highly misleading statistics” and that the flu season had merely arrived a few weeks early.
Government spin or not, the strikes have sounded alarm in the NHS, which is struggling to deal cope with a record flu hospitalisations for this time of year, filling 1700 beds. More and more hospitals are unable to contend with these numbers and having to declare a “critical incident”.
It is not a stretch to say that the NHI Act has been one of the most controversial pieces of legislation in post-apartheid South Africa.
Since President Cyril Ramaphosa signed it into law in May 2024, just two weeks ahead of the national and provincial elections, at least nine different court cases have been launched against the Act, or specific provisions in the Act. None of those cases have made it through the courts and it seems likely some might be combined.
In one preliminary to the bigger court battles, the North Gauteng High Court in Pretoria ordered Ramaphosa to provide the record of his decision to sign the act, but the President is challenging that order.
A subtext to the torrent of court cases is the sense that it is only through litigation that the NHI Act might be scrapped, or that some of the most controversial provisions in it might be repealed. The alternative to litigation, political compromise, for now seems dead in the water. There was some hope for such compromise around a year ago when Business Unity South Africa and several healthcare worker groups pushed government for a change in course – but while the Presidency seemed open to considering changes, the health minister did not, and eventually the ANC, and government with it, decided to buckle down behind their current NHI plans.
The door to political compromise could of course reopen should the balance of political power in the country change – as it will surely do after the 2029 elections, if not earlier.
To the courts then
There has been much media coverage of the various court cases challenging the NHI Act. Understandably, a lot of the public statements were aimed at drumming up public support for the various points of view. In the end, the courts will hopefully look past the rhetoric and politicking and judge the cases on their merits.
This is why in recent months Spotlight put substantial resources into combing through seemingly endless court papers and chatting to a variety of lawyers in an attempt to sift the wheat from the chaff. As with many other court cases we’ve reported on, we suspect the various NHI-related cases will in the end turn on just a few key legal questions. In a special two-part series, we tried to pin down what these key legal questions are likely to be – you can see part 1 here and part 2 here. (Thank you to the three lawyers we quote in the article, as well as those who shared their views, but opted not to be named and quoted.)
In our view, this crystallisation of the legal case against the NHI Act, and/or specific provisions in the Act, is the most notable NHI-related development this year. After all, a major ruling against the Act could make much else moot.
Other NHI developments
Meanwhile, the Department of Health is moving ahead on the assumption that NHI will be implemented as envisaged in the Act. The first formal step towards setting out the proposed governance structure and processes of the NHI Fund is underway with draft regulations that were published in the Government Gazette in March. Amongst others, the regulations provide for the appointment of the board of the NHI Fund, the fund’s chief executive officer, and for a benefits advisory committee and a healthcare benefits pricing committee. In the background here is the fact that, until the NHI Fund has been established as a public entity, it cannot be awarded a budget by parliament.
One source of funding for NHI could be the phasing out of medical scheme tax credits. This is according to a presentation by the National Health Department’s NHI lead, Dr Nicholas Crisp, who was addressing the Standing Committee on Appropriations in the National Assembly. The presentation notes that medical scheme tax credits could raise as much as R34bn for the NHI Fund by 2027/28. At the moment, eligible beneficiaries receive medical scheme tax credits to the value of R364 per month for the primary member, R364 for the first dependant, and R246 for each additional dependant. The rough idea is that tax credits would first be phased out for high-income earners. This would eventually be followed by the state scrapping medical scheme subsidies to civil servants.
But Finance Minister Enoch Godongwana seems unconvinced. He told BusinessDay: “It’s actually an attack on the middle class”.
And indeed, the proposed scrapping of medical aid subsidies has added fuel to suggestions that government is intentionally undermining the viability of private healthcare in South Africa. A set of recommendations on how to better regulate the country’s private healthcare sector remains largely unimplemented six years after being published. Government did publish draft regulations for tariff determination in the private sector in February, but, as we recently reported, those draft regulations have now been withdrawn. In fact, those draft regulations were so poorly thought out that one wonders whether they were a serious attempt at addressing the issue in the first place.
According to Crisp’s presentation, NHI could take “10, 15 or more” years to implement. There is some welcome realism in this. Rather absurdly, Section 57 of the NHI Act still states that it will be introduced in two phases, between 2023 and 2026, and between 2026 and 2028.
Several experts have suggested to Spotlight that, mainly for financial reasons, NHI is essentially dead in the water and that the more serious people in the government and the ANC know this. Few are however willing to say this publicly. Others, like Crisp and Health Minister Dr Aaron Motsoaledi, would of course beg to differ, and mean it.
Not the only solution
One thing that should not get lost in all this is that things really do need to change. Apart from being extremely unequal, much of the healthcare system in South Africa is deeply dysfunctional. But Motsoaledi is wrong when he suggests that the specific system set out in the NHI Act is the only possible solution. As we’ve previously argued, there are other viable paths to universal health coverage, even if the current set of leaders in the ANC refuses to seriously consider them.
One of the great tragedies of NHI is that for all the noise, we have never really had an informed public debate about the policy options and the reasons for going with one set of health reforms rather than another. There were few things as depressing as watching members of parliament’s portfolio committee for health reducing someone’s nuanced and constructive feedback on the Bill to a simple question of whether someone is for or against NHI. The ANC of course had a majority in parliament prior to the 2024 elections, so maybe there was a sense that they did not need to listen and do the hard work of engaging and bringing people along with them.
Either way, it now seems likely that in 2026, the courts will have to make one or more landmark rulings that will determine the future of NHI. We have some idea of what the key issues will be on which those cases will turn, but as to how the courts will decide, your guess is as good as ours.
#InsideTheBox is a column by Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. (Photo: Supplied)
By Andy Gray
There has been much confusion and misunderstandings about how cannabis and associated products are regulated in South Africa, with government’s own missteps adding to the uncertainty. In his last #InsideTheBox column for the year, Dr Andy Gray clearly sets out the current legal and regulatory situation and where we’re heading.
There is a fundamental assumption that underpins much of the legislation relating to pharmacologically active substances, especially those that have neuropsychiatric effects. Some are recognised as having legitimate medicinal uses, in humans and/or animals, and so are regulated as medicines. Others are deemed to have no legitimate medicinal uses, and so their possession and use is prohibited or even criminalised. Some of these substances are obtained from natural sources, such as plants or fungi, and some have been recognised and used since antiquity, precisely for their effects, both for pleasure and ritual.
Cannabis is a prime example, which grows on all continents other than Antarctica and has been used for a wide variety of purposes, both for its pharmacological actions and for its physical attributes, as a source of fibre and nutrition.
South Africa has a long and complex history with regard to cannabis. It was the South African government which proposed to the League of Nations Dangerous Drugs Committee in 1923 that cannabis be subjected to international regulation. That status remains in place, in terms of the Single Convention on Narcotic Drugs, 1961, to which South Africa is a signatory. Schedule I to the Convention, which is maintained by the International Narcotics Control Board, includes “the flowering or fruiting tops of the cannabis plant”, as well as “the separated resin, crude or purified, obtained from the cannabis plant”. Parties to the Convention are required to “adopt such measures as may be necessary to prevent the misuse of, and illicit traffic in, the leaves of the cannabis plant”. Cultivation of cannabis is to be regulated in the same manner as that applied to opium poppies, but with an important caveat: “This Convention shall not apply to the cultivation of the cannabis plant exclusively for industrial purposes (fibre and seed) or horticultural purposes.”
As a result, cannabis was for many years listed as a Schedule 7 substance in terms of South Africa’s Medicines and Related Substances Act, 1965, and also included in the “Undesirable Dependence-Producing Substances” in terms of the Drugs and Drug Trafficking Act, 1992. While exceptional access was allowed for research, analysis or use by a particular patient, substances in those categories could not ordinarily be possessed or sold.
That entire legal construct was overturned by a 2018 Constitutional Court judgment which declared the relevant sections of both laws unconstitutional “to the extent that they criminalise the use or possession in private or cultivation in a private place of cannabis by an adult for his or her own personal consumption in private”. The court allowed legislators a period of 24 months to remedy the situation.
THC and CBD
Although the cannabis plant contains over 100 identifiable chemical components, two are of particular importance. Tetrahydrocannabinol (THC) is the psychoactive component, whereas cannabidiol (CBD) is not psychoactive. At higher doses, cannabidiol has been shown to be effective in the management of some paediatric epilepsy syndromes.
The first change made to comply with the Constitutional Court judgment involved moving THC to Schedule 6 (alongside morphine, for example) and CBD to Schedule 4 (as a prescription medicine). The Schedule 6 inscription also included an exception to allow adult use, echoing the wording in the court judgment. The control measures applicable to a Schedule 6 substance (such as the need for a prescription) do not apply when “raw cannabis plant material is cultivated, possessed and consumed by an adult, in private for personal consumption”. The Schedule 4 inscription also allowed for low-dose CBD products (containing a maximum of 20mg per day and 600mg per pack) to be regulated as a complementary medicine, provided the labelling made only a low-risk claim (a general health enhancement or health maintenance claim or a claim of relief from minor symptoms).
The South African Health Products Regulatory Authority (SAHPRA) has issued just over a hundred licences for the cultivation and export of cannabis for medicinal purposes. These licences are for the preparation of the raw material from which medicines could be made, but no THC-containing products have yet been registered in South Africa. SAHPRA does not report on the number of section 21 permits issued to individual patients seeking access to THC-containing medicines, nor on the sources of unregistered medicines approved in that manner (section 21 permits allows for access to medicines not registered by SAHPRA).
SAHPRA’s cannabis cultivation permits do not allow the sale of cannabis products directly to the public. SAHPRA has not issued licences to any retail outlets for cannabis or cannabis-containing products. Retail outlets claiming to be licensed “dispensaries” are therefore operating illegally.
In 2024, the Schedules were again updated, with this exception inserted: “in raw cannabis plant material cultivated and possessed in accordance with a permit issued in terms of the Plant Improvement Act (Act 11 of 2018) and processed products manufactured from such material, intended for agricultural or industrial purposes, including the manufacture of consumer items or products which have no pharmacological action or medicinal purpose”.
The Plant Improvement Act, 2018, is intended to regulate the propagation and sale of particular plants, setting quality standards for economically important varieties, such as wheat. In November 2025, the Minister of Agriculture, Land Reform and Rural Development issued regulations in terms of this Act, setting a THC limit of 2% for the leaves and flowering heads of cannabis plants considered to be “hemp” (low-THC cannabis). That action provides the clarity required to interpret the Schedules to the Medicines Act and creates a process for the issuing of “hemp” permits for the cultivation and sale of low-THC cannabis for industrial applications.
‘A work in progress’
Bringing the Drugs and Drug Trafficking Act into alignment with the Constitutional Court judgment has been far more complex than the Medicines Act and is still a work in progress. The section of the Drugs Act which enabled the Minister of Justice to make schedules listing substances in different categories was found to be unconstitutional in 2020. Future changes to the schedules will require an Act of Parliament. Distinct from the Schedules to the Medicines Act, these lists designate which substances, for example are considered “Undesirable Dependence-Producing Substances”, the possession of which may be a criminal offence.
Instead, the Minister of Justice and Correctional Services tabled a separate Bill in 2019, which was finally passed as the Cannabis for Private Purposes Act, 2024. While that Act has been assented to by the President, it has not yet been promulgated and no regulations have been issued. The legislation is therefore not yet in operation. Regulations are needed, for example, to specify the amounts of cannabis that can be cultivated, possessed or transported. Most importantly, though enabling the possession or cultivation of cannabis in a private place, and therefore personal consumption by an adult, the Act does not enable the commercialisation of cannabis for “recreational” or “adult use”, as is the case with alcoholic beverages or tobacco products.
South Africa’s Cannabis Master Plan, which envisages three separate value chains, covering medicinal cannabis, hemp, and adult use, is now being driven by the Department of Trade, Industry and Competition (DTIC). The DTIC plans to submit a Hemp and Cannabis Commercialisation Policy to Cabinet by April 2026 and to table an Overarching Cannabis Bill by mid-2027.
The 2018 Constitutional Court judgment overturned almost a century of established practice. While the evidence for the medicinal value of cannabis and specific cannabinoids is still scanty, the assumption that such products have no medicinal value at all is no longer tenable. As with all pharmaceutical products, this is a highly regulated market with high barriers to entry.
An industrial market for low-THC cannabis is already well established and the necessary steps to enable its growth are now in place. However, the ill-informed ban on the inclusion of any cannabis components in foodstuffs, which was issued and then rapidly repealed in 2025, is indicative of the lack of coherence in government policy. The challenge remains the commercialisation of an adult use market, and whether that will enable the involvement of the small-scale rural growers who have traditionally met demand for the product.
Cannabis policy therefore remains in flux, and the entire legislative process has been marked by missteps, missed steps, reverses, ambivalence and confusion. Some pieces of the picture are in place, but others remain uncertain or incomplete.
*Dr Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is part of a series of #InsideTheBox columns he is writing for Spotlight.
Disclosure: Gray serves on three technical advisory committees at the South African Health Products Regulatory Authority and previously chaired the Cannabis Working Group.
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.
Getting to grips with rising diabetes rates is arguably one of the most urgent tasks for South Africa’s public healthcare system, but the setbacks keep coming. While some communities are facing shortages of blood sugar meters and insulin pens, a smaller wave of insulin vial shortages is now on the horizon.
In August, activist Eksoda Mazibuko was sure that years of community organising had finally yielded tangible results for people with diabetes in Hluvukani, a town in Mpumalanga.
The 35-year-old had just received R50 000 from Good Morning Angels, Jacaranda FM’s community upliftment project. It was more than enough for him to buy blood sugar meters and test strips for the fifty-person support group he runs at Tintswalo Hospital in Acornhoek, where stock had run out.
When the body can’t make or use insulin – the hormone that keeps blood sugar in check – people have to watch their levels, so they know how to eat and medicate themselves. It’s a process held together by medicines and an ecosystem of tools such as meters, strips, pens, lancets, needles, syringes, which unravels when one part is missing. Over time, poorly controlled blood sugar causes cumulative damage to one’s body that can result in severe complications such as amputation, blindness, kidney damage, and stroke.
Most people who take pills to treat diabetes need monitoring from time to time, but for the majority of those who are on insulin treatment, it is essential. People with diabetes who are taking insulin must check their blood sugar levels multiple times a day. To do this, they need glucometers – devices that measure the sugar levels in a drop of blood. But access to glucometers is a challenge. Spotlight previously reported that not everyone who needs these home testing devices is given one and those who do receive them rarely get enough test strips and lances to enable proper monitoring of their blood sugar levels.
Without tests and test strips, people in Hluvukani had no way of knowing how to adjust their insulin. Injecting the wrong amount could in extreme cases result in someone going into a coma or dying.
Mazibuko himself, who was diagnosed in 2003 and has always needed insulin, knows how terrifying it can be when monitoring tools are out of reach.
When the devices and test strips finally arrived, he shared a celebratory photo on social media. Excited messages streamed in on WhatsApp, but among them was an upsetting note from a government pharmacist: “You should have asked me before you ordered.”
Unbeknownst to the hospital staff that helped Mazibuko choose the device, the national government’s supplier would be changing, as it does every three years or so when a new tender is awarded. That means state pharmacies would soon stock a different kind of test strip.
Glucometers generally can’t interpret test strips from a different brand or model, so the glucometers that he’d already started to hand out would soon be useless.
“They were already open so I couldn’t send them back. After I worked so hard to get those machines for my community members,” said Mazibuko. “It was heartbreaking.”
According to a report from the Clinton Health Access Initiative, in poorer countries companies make most of their profit on the test strips rather than the glucometers used to read the strips. Spotlight understands that some companies go as far as giving away the devices to lock people into using their specific test strips. According to Cathy Haldane, who leads the non-communicable diseases team at FIND (a global diagnostics alliance), there have been some efforts toward encouraging universal interoperability of test strips, but these efforts haven’t gathered much steam.
Why diabetes is still a national guessing game
South Africa is one of the few countries that buys blood glucose meters and test strips en masse, but there are still lots of people who are treated with insulin who don’t have access to them.
One reason for this is that the national health department buys machines and strips for the public sector but it’s up to provinces to manage stock at pharmacies and clinics, explains Haldane.
A lack of good quality diabetes data could be making harder for health department staff to predict how much they’ll need, she says. Unlike the country’s digital HIV & TB tracking system, there’s no centralised database for diabetes and other chronic diseases such as high blood pressure and cancer. As Spotlight previously reported in-depth, there is a serious lack of reliable diabetes data for South Africa. Haldane says, “that’s how people on insulin treatment who should get a machine and monthly test strips end up going without”.
Not having reliable data leaves national planners, doctors and nurses in the dark about how many people need blood sugar monitors, where the system is failing and how the country is faring against targets outlined in the health department’s action plan for chronic diseases, which lapses in 2027. The plan states that by 2027, the health department wants at least 50% of people receiving care for diabetes to have their blood sugar under control. The available data though, all from pockets of academic research, suggests that we are falling far short of this target.
The diabetes data that is available paints a harrowing picture.
According to a StatsSA report on non-communicable diseases, diabetes was the leading underlying cause of death for women and second biggest underlying cause of death for men in 2018. While other reports suggest that diabetes is lower on the list of top killers, it clearly does claim many lives in the country. The International Diabetes Federation estimates that about half of people with diabetes in South Africa haven’t been diagnosed.
If trends continue, 2018 research suggests the treatment, management and complications of type two diabetes could cost the government as much as R35-billion by 2030.
In rural KZN, insulin pen stockouts persist
Meanwhile, more than 700 kilometers from Hluvukani, in KwaZulu-Natal’s rural King Cetshwayo district, some healthcare staff are using their own money to help keep diabetes services going.
Indira Govender, a doctor affiliated with the Rural Doctors Association of South Africa (Rudasa) who works in the area, says clinic managers are often the ones buying new batteries for blood sugar meters used in the facility and by patients.
The devices use the coin-like batteries also used in some watches, which aren’t easy to find in far flung areas.
Govender worries about the patients on insulin who still have to use a glass vial and syringe to inject themselves. “Not everybody has a fridge to store the insulin in. People struggle to draw up the right amount of insulin, sometimes because they can’t see well,” says Govender.
South Africa ran out of pens in 2024 when the health department’s longtime supplier, Novo Nordisk, stopped manufacturing pens prefilled with the cheapest form of insulin. The news came as global demand surged for one of Novo Nordisk’s long-acting diabetes medicines, semaglutide, because it was shown to also be effective for weight loss. Semaglutide is also provided in pens rather than vials.
In a 2024 letter to Novo Nordisk’s chief executive officer, MSF demanded that the pharma giant either ensure continued supply of the cheapest insulin pens in South Africa or that it offer a newer kind of pen at $1 each. That’s the amount that MSF’s research found would cover production costs, a fair profit margin and an allowance for tax.
The newer pens are filled with a form of insulin that takes effect faster and lasts for longer than previous versions. Novo Nordisk signed a deal in May in which it commits to providing these pens to South Africa until 2027. The department was charged just under $4 (around R75) per pen.
At the government clinic where Govender works in KwaZulu-Natal, however, insulin pens have reportedly not returned to pharmacy shelves.
“We haven’t had pens here since at least 2024,” says Govender.
The KwaZulu-Natal health department did not respond to Spotlight’s queries about the delivery delays.
Local consequences of global disruptions
While some communities are still waiting for insulin pens, a smaller wave of vial shortages is on its way for South Africa, according to an October circular.
Novo Nordisk told the health department to expect six to eight week delays in the delivery of short-acting, medium-acting and longer-acting insulin sold in 10ml vials. The department did not respond to Spotlight’s queries, but the circular listed four alternative prefilled pens that are available and expects stock to stabilise by January 2026.
One of the listed alternatives, Novo Nordisk’s NovoMix30, is also on a list of insulin pens and vials that will be discontinued in 2026, according to a directive issued by the health ministry in New Zealand.
No such directive has been issued by South Africa’s health department. Candice Sehoma, advocacy advisor for MSF Access in Southern Africa, says she would be surprised if the country avoids it.
It’s part of a concerning pattern of shortages of essential medicines worldwide, she says.
“We’re seeing more and more companies deprioritising insulin and discontinuing affordable medicines,” says Sehoma.
When there’s insulin but no food
While his stock of test strips lasts, Mazibuko takes them along when he visits members of his support group in Hluvukani.
They could technically find matching strips in the private sector, but they’re likely to be too expensive. A 2024 study found that for someone earning South Africa’s minimum wage, a single blood-sugar test in the private sector costs more than an hour of work, and a month of basic diabetes supplies can swallow three full days’ wages.
Many of the people on Mazibuko’s route are facing far more serious problems than the loss of glucometers. Those who aren’t working are often not taking their medication well either, Mazibuko says. “They don’t have food so they skip breakfast and also skip their insulin because they’re scared.”
Injecting insulin on an empty stomach can cause a sudden blood sugar crash that could lead to dizziness, confusion or a seizure.
Mazibuko is working on a skills programme to help these people make a living that might also protect them from lapses in basic supplies at government health facilities, which he claims happens often.
“Sometimes you go to the clinic, they tell you that they’ve run out of insulin, or they tell you to buy your own needles and syringes. You will have to do that with borrowed money,” says Mazibuko.
The Mpumalanga health department also did not respond to Spotlight’s requests for comment.
Republished from Spotlight under a Creative Commons licence.
The South African Health Products Regulatory Authority (SAHPRA) has officially been accepted as a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), following an ICH assessment of compliance with requirements for membership, including a formal presentation outlining SAHPRA’s interest, progress, and milestones in implementing ICH principles.
The ICH is a unique global body that brings together regulatory authorities and the pharmaceutical industry to align scientific and technical standards for the registration of medicines. Since its establishment in 1990, it has evolved to support an increasingly globalised pharmaceutical environment. Its mission is to promote worldwide harmonisation to ensure that safe, effective, and high-quality medicines are developed and registered efficiently. This harmonisation is achieved through the development of ICH Guidelines, which are formulated through scientific consensus between regulators and industry experts. Successful adoption relies heavily on regulators’ commitment to implement these final Guidelines within their national systems.
The ICH Assembly met in person on 18-19 November 2025 in Singapore, in parallel with meetings of 12 Working Groups and preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee (SC).
“ICH is delighted to welcome NAFDAC, Nigeria, and SAHPRA, South Africa, as new ICH Members, in addition to two new Observers: DIGEMAPS, Dominican Republic, and Philippine FDA, Philippines, bringing ICH to a total of 25 Members and 41 Observers.”
Welcoming SAHPRA’s membership, CEO Dr Boitumelo Semete-Makokotlela said: “This is a significant milestone for the South African Health Products Regulatory Authority. Membership of the ICH strengthens our commitment to the three pillars of safety, quality, and efficacy, while ensuring that our processes remain resource-efficient. This development allows SAHPRA to benchmark its regulatory practices against global best practice for the benefit of all people living in South Africa.”
The cancellation of US aid funding to South Africa is harming the country’s HIV response. Source: Unsplash CC0
By Marcus Low and Nathan Geffen
The number of HIV viral load tests is significantly lower than expected, according to an analysis of data from the National Health Laboratory Service which Spotlight and GroundUp obtained through the Promotion of Access to Information Act.
The number of HIV viral load tests recorded by the National Health Laboratory Service (NHLS) is significantly less than expected since February 2025. We are aware of no compelling reason to explain this except the withdrawal of US aid.
All patients in the public health system with HIV are supposed to get viral load tests regularly, usually once a year. These tests are used to determine if HIV is being suppressed successfully in their blood using ARV medicines. If the number of viral load tests declines, it likely indicates either that patients are being lost to the public health system, they are being monitored less diligently, or the system for recording viral load tests has become less accurate. Any one of these would imply a serious hit to South Africa’s public sector HIV programme.
GroundUp and Spotlight used the Promotion of Access to Information Act to request, among other things, viral load test numbers from the NHLS. We were provided a spreadsheet with the number of tests per month for each province from January 2015 to September 2025.
The current US Administration began taking steps to reduce US aid across the world after Donald Trump was inaugurated as president on 20 January 2025. Billions of rands have been withdrawn from South Africa. This caused some services, especially for vulnerable people — including gay men, sex workers and trans people— to close almost immediately, such as the Ivan Toms Centre in Cape Town and Wits University facilities in Johannesburg. US aid also funded support systems, such as data collection.
Public health experts have accused the government of being in denial about the consequences of the withdrawal of US aid. Health Minister Dr Aaron Motsoaledi has responded defiantly. In May, he stated that a record number of people had been initiated on ARVs over the previous months, a claim disputed by epidemiologists.
We asked a biostatistician to examine the NHLS data we received. She analysed the change in viral load tests by month and province over time. She found that the number of viral load tests for the period February to September this year is statistically significantly lower than what one would expect based on previous years. This confirms the view of public health experts: the withdrawal of US aid from South Africa has hit the HIV programme badly.
The decline in viral load numbers was previously reported by the Daily Maverick and Reuters for March and April. This was inevitable given the sudden withdrawal of US aid. But the new data shows that the decline has been sustained until September. The decline has occurred in every province except Limpopo.
How Viral Load Testing Performed Against Expectations, Feb–Sept 2025
Province
Predicted
Actual
Difference
% Difference
p_value
Eastern Cape
545,061
463,510
-81,551
-15
0.0007
Free State
285,423
234,671
-50,752
-18
0.0002
Gauteng
1,210,891
1,006,833
-204,058
-17
0.0002
KwaZulu-Natal
1,475,360
1,284,008
-191,352
-13
0.0001
Limpopo
419,357
441,314
21,957
5
0.1550
Mpumalanga
532,713
450,495
-82,218
-15
0.0007
North West
326,907
292,150
-34,757
-11
0.0002
Northern Cape
64,855
58,746
-6,109
-9
0.0017
Western Cape
324,074
290,011
-34,063
-11
0.0205
National
5,184,640
4,521,738
-662,902
-13
0.0003
*This table presents the expected and actual numbers of viral load tests conducted by the National Health Laboratory Service in South Africa from February to September 2025.
By looking at the change in viral load tests since 2015, a biostatistician estimated the number of viral load tests that there should have been for the period February to September 2025 using a standard linear regression model. She found that the actual number of tests declined significantly. A p-value less than 0.05 is considered statistically significant. Except for Limpopo, the p-values are substantially less than 0.05 for every province. The analysis takes into account that the NHLS suffered a data hack in 2024, and consequently, there is missing data for a few months.
An even simpler analysis also raises red flags. The absolute number of viral load tests conducted from February to September 2025 (4,521,738) is slightly lower than it was over the same period in 2023 (4,554,463) (due to a cyber attack, the NHLS’s 2024 figures are not a reliable comparison). Given that the number of people on HIV treatment is expected to increase over time and that everyone should be getting at least one viral load test per year, one would expect the number of viral load tests to have increased by a few hundred thousand since 2023.
These results show that the HIV programme has been set back. It is possible that tens of thousands of people have been lost to care. Also possible is that they are disproportionately the most vulnerable patients treated at specialist US funded facilities that closed as a consequence of the funding cuts.
Nevertheless the HIV programme is still successfully treating millions of people and South Africa is far better off than other African countries, such as Mozambique, whose response to HIV is almost entirely paid for with foreign aid.
Fewer patients have viral rebound. But is it a silver lining?
People with HIV who are on ARVs should have, after a few weeks, an undetectable amount of virus in their blood. This is what the viral load test measures. But if the ARVs stop working or a person stops taking their ARVs regularly, the virus will rebound in their blood.
The NHLS counts the number of viral load tests for which patients have more than a thousand copies of HIV per drop of blood. For these patients, the virus has rebounded in their blood.
The percentage of viral rebound cases has come down in 2025.
This might be because the standard ARV regimen has improved. A drug called dolutegravir is now part of the regimen, and it is known to do a better job of suppressing HIV than the drug it replaced a few years ago. This would be the good-news explanation, a silver lining in the data.
But it’s also possible that it’s because vulnerable patients treated in specialist clinics funded by US aid are more likely to have viral rebound and they are the ones who have been lost to the HIV programme. This would be the bad-news explanation.
At this point, we don’t have data to know which explanation of the viral rebound improvement is correct. The situation also varies substantially by province. The real picture might be a complex interaction of multiple factors.
The NHI Act is facing a slew of legal challenges from multiple organisations. For this special series, Spotlight combed through court papers, and spoke with legal experts to pin down what specific arguments litigants are betting on. In part one, we focused on the claim that the scheme is unaffordable and therefore unreasonable. Here, in part two, we discuss the argument that the NHI will unjustifiably compromise people’s right to access healthcare services.
Since the National Health Insurance (NHI) Act was signed into law by President Cyril Ramaphosa in May 2024, eight different groups have challenged it in court, with some filing multiple applications.
One core argument which appears in different ways across many of these submissions is that under the NHI, people will have access to fewer health services, or simply a reduced quality of care, than what they currently have.
If this was true then the NHI could be in violation of Section 27 of the country’s Constitution, according to which government has to do what it can to achieve the “progressive realisation” of the right to healthcare services (along with the right to food, water and social security). Courts have often interpreted this to mean that the government not only has to take active steps to advance people’s access to healthcare, but also that it should avoid doing things that might limit their existing rights.
Sasha Stevenson, who heads the public interest law clinic SECTION27, explained that the Constitution uses the phrase “progressive realisation” because of a “recognition that not everything can be perfect straight away, so the government needs to take steps to move toward full realisation of certain socioeconomic rights”. She added: “What that means logically is that you can’t move backwards.”
There is however some wiggle room, said Stevenson. This is because the Constitution only expects the government to take “reasonable” steps that are “within its available resources”, she said.
Thus, if the government was cash-strapped and able to show that it simply couldn’t afford to maintain its current levels of health expenditure without seriously compromising other core rights, then it may be able to take steps backward without violating the Constitution. Stevenson argued that, at its core, the key idea is simply that the state must fully justify what it is doing.
To show that the NHI Act violates Section 27 of the Constitution, litigants will need to prove that it not only limits people’s right to healthcare, but that the government hasn’t provided good enough reasons for why it is doing this.
But why are litigants arguing that the NHI would limit people’s right to healthcare in the first place? Let’s start with medical scheme members.
Cutting out medical schemes
Section 33 of the NHI Act states that once the scheme is fully implemented, medical schemes will only be allowed to cover top-up health services that aren’t covered by the NHI. In addition, the Act requires “mandatory prepayment”, meaning people will have to pay to be covered by the NHI, whether or not they want to join.
Thus, unless someone was able to afford both the mandatory prepayment for the NHI, and complimentary cover from their medical schemes, they would have to switch to relying solely on the NHI for their medical coverage.
This is an issue for the Board of Healthcare Funders (BHF), which represents the medical insurance industry, and was one of the first groups to challenge the NHI in court.
“When you look at what medical scheme members are entitled to now versus to what they’re entitled to under an NHI scheme, it’s a regressive process,” Neil Kirby, who heads the healthcare and life science practice area at Werksmans Attorneys, which represents BHF, told Spotlight.
“You probably would be entitled to less under an NHI scheme than you would under the current regime,” he said.
Of course, at present we don’t yet know exactly what health services the NHI will cover, as the package of benefits has not yet been detailed. It thus may be difficult for courts to assess this claim.
When asked about this, Kirby said: “The current assessment by various economic experts is that if one were to price the value of the current basket of prescribed minimum benefits [the services which medical schemes have to cover]… and spread that cost over the entire population covered by NHI, the NHI would be entirely unaffordable.”
As a result, he said: “There would have to be some degree of compromise in respect of the benefits to be provided under NHI in order for the state to afford to purchase those benefits”. In other words, they’d need to offer less than what medical schemes currently cover.
In response to this, the National Health Department’s NHI lead, Dr Nicholas Crisp, denied that people’s coverage would be compromised under the NHI. In a conversation with Spotlight, he argued that the NHI would not need to incur the same total payment obligations as medical schemes in order to cover a comprehensive package of health services. This is given that it could purchase services more efficiently, he said.
ANC President Cyril Ramaphosa, with Minister of Health, Dr Joe Phaahla and his deputy Dr Sibongiseni Dhlomo, during the signing into law of the National Health Insurance Bill. (Photo: @MYANC/Twitter)
Crisp justified this on several grounds. One is that private health providers are currently accused of overservicing clients, which he argues could be rectified under the NHI.
For instance, Crisp pointed to the Competition Commission’s Health Market Inquiry report, which found that private health facilities are reimbursed for each consultation, operation or other service that they provide. The report found that this “creates an incentive for providers to over-service patients, to over-invest in generously remunerated services, and under-invest in poorly remunerated services [even if they have a positive impact on patient outcomes]”.
Under the NHI scheme, a different reimbursement model would be used to cover health providers both at private and public health facilities. For instance, in the primary healthcare sector, the NHI would rely on capitation. This means that health providers would be provided a fixed fee for each patient, rather than for each individual service, removing the incentive to overservice, and thus overcharge.
Crisp also argued that the government is able to procure medicines and other health services at lower prices than the private sector partly by buying in bulk. Additionally, he noted that billions of rands are reportedly lost in fraud, waste and abuse within the private health sector, due for instance to fraudulent medical claims.
According to Crisp, the NHI fund would be able to save on all of these unnecessary costs.
Pushing back on this view, Professor Alex van den Heever, from the Wits school of governance, told Spotlight that there was no reason to think the state could purchase cover more efficiently than the private medical schemes.
In the public sector, he said that “whether you have a [national] monopoly like Eskom, or a public monopoly in a province like the Gauteng Department of Health, they hardly spend their money efficiently”. Van den Heever added: “For Tembisa hospital to lose R2 billion and not get a cent back in terms of actual products is an indication of the risk.”
He was referring to a damning report by the Special Investigating Unit which confirmed large-scale looting to the tune of around R2 billion meant for patient care at Tembisa Hospital in Gauteng’s East Rand. Their investigation zoomed in on nine criminal syndicates, with three of them pocketing nearly R1.7 billion. The SIU found that R122 million in kickbacks were paid to at least 15 current and former health department officials.
“So you have to have some real evidence that [the state would] be able to procure services more efficiently, and there’s no evidence. All the historical evidence suggests they’d do worse,” Van den Heever said.
Does the state have good reasons?
If litigants are able to show that the NHI was regressive for people on medical schemes in the sense that it diminished their rights, the courts might still decide that the government had provided a good enough justification for why these limitations are reasonable.
But according to Van den Heever, the government has thus far categorically failed to do this.
“From the green paper to the white paper to the [NHI] bill, there is not a single technical document that provides a clear rationale for Section 33 [the restriction on medical schemes],” said Van den Heever. Overall, the very question about what specific problems the NHI is trying to solve and how it would do this remain elusive.
He added that one public health professor had submitted court papers in support of NHI which argued that the existence of the private health sector undermines the public sector, for instance by hoarding doctors and specialists. Yet according to Van den Heever, “no technical report has ever been produced” which provides evidence for that claim.
Additionally, he noted that doctor shortages at public facilities are evidently not driven by private sector hoarding but by financial constraints emanating from mismanagement and corruption. This prevents public hospitals from hiring people who are available for work. (Previous Spotlight reporting has also suggested that the shortage of doctors in the public sector is driven by a lack of funding, rather than a lack of doctors.)
Similarly, the Hospital Association of South Africa (HASA) argued in court papers that the NHI Act’s restrictions on medical schemes serves “no rational, reasonable or economic purpose”.
The association also argued that there are no examples of health systems that impose these restrictions, aside from a few provinces in Canada, and thus Section 33 of the NHI Act is clearly “not a requirement for a successful national health system aimed at [universal health coverage]”.
Defending the restriction on medical schemes, Crisp said that if two different streams of health financing are allowed to continue, then so will inequity. He also stated that single-payer health systems funded by the state are not unusual, even if their exact form differs across countries.
Limiting the rights of public sector users
In addition to the arguments that the NHI Act will unjustly restrict the rights of medical scheme members, some have also argued that it will be regressive for public sector users.
One organisation making this argument is the Treatment Action Campaign (TAC). It has applied to be a friend of the court in the dispute between the South African Medical Association (SAMA) and the government. The TAC argued that the governance provisions within the NHI are so weak that they threaten the entire health system, including for those relying on government health facilities.
Stevenson, whose organisation SECTION27 is represents the TAC, said that checks and balances within the governance of the NHI fund are deficient, leaving it vulnerable to corruption and mismanagement.
Van den Heever, who is serving as an expert in the SAMA case, seconded this concern. He also said that the NHI ultimately centralises the management and purchasing of healthcare services under national institutions. This introduces inefficiencies that will compromise patient care at government facilities, he argued.
“Healthcare is [a sector] where the purchasing and management [should be] decentralised,” he said, largely because different communities have different health needs.
Even in the United Kingdom, said Van den Heever, the responsibility for the National Health Service, which provides the majority of medical services, is devolved across England, Wales, Scotland and northern Ireland, with semi-autonomous trusts, boards and hospitals in each country having a major say in operational decisions.
Van den Heever argued that not only would the centralisation of health under NHI be highly undesirable, but the actual transition to this system from one in which provinces are responsible for healthcare would be enormously disruptive, impacting patient care.
Asylum seekers compromised by NHI
An additional argument concerns the rights of asylum seekers and undocumented people, a central concern for SAMA and the TAC.
Stevenson explained that under our current system, all people, including asylum seekers and undocumented migrants, have the right to free primary healthcare services in the public sector. Just like ordinary citizens, asylum seekers also have the right to access public hospitals on a means-tested basis (meaning your level of subsidisation is determined by what you can afford).
In addition, pregnant and lactating women, as well as children under six, are entitled to all services regardless of documentation status, and the government is compelled to screen, test and treat anyone with HIV.
Under the NHI Act, all of these rights are compromised for asylum seekers and undocumented migrants. This is because Section 4 of the NHI Act states that these groups are only covered for emergency care and for services related to notifiable conditions. The country’s list of notifiable conditions includes diseases like cholera and pulmonary TB, but excludes HIV, diabetes and many other common diseases.
Stevenson argued that this not only compromises the rights of individual asylum seekers, but makes for terrible public health policy.
“It essentially means dropping part of our population off the HIV programme,” she said.
“It would also mean we’re waiting more and more for emergencies, because people can access care [at the point of emergency] but not at a primary healthcare level. So you can’t go and get yourself checked for diabetes… But when your foot is gangrenous [a symptom of untreated diabetes] and needs amputation then you’re in an emergency situation.”
Overall, the Act in its current form constitutes a clear regression for asylum seekers, said Stevenson, and the government has provided no comprehensive justification for why it is excluding this group. If the government wanted to justify the exclusion of migrants on the basis that it is too costly to cover them under the NHI then they “have to show the numbers”, Stevenson said.
Thus far, they haven’t done so.
“There has been no assessment of the so-called burden of migrants in the health sector, let alone how many people fit into which category or how much money is spent on services for people,” said Stevenson, “Instead, there has just been this persistent scapegoating, and these broad statements about the burden.”
Court documents submitted by SAMA have made similar allegations.
“There is no reliable study which shows the extension of the NHI to foreigners will have a significant effect on the affordability of the NHI,” it argued, noting that in fact the converse may be true, as the contributions of foreigners to the economy may outweigh the costs of providing them healthcare.
Asked about this, Crisp said that they were aware of the issue, and that while it was a complicated matter, the state would ultimately have to ensure healthcare for all people, in line with its domestic laws and international agreements.
Disclosure: SECTION27 is mentioned in this article. Spotlight is published by SECTION27, but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council and subject to the South African Press Code.
Potential partnerships between the public and private healthcare sectors have largely not been harnessed. Photo by Sora Shimazaki
By Ufrieda Ho
Government and the private sector could work together much more effectively to improve healthcare services in South Africa, but the potential of such a partnership remains largely untapped, delegates heard last week at the Hospital Association of South Africa conference.
Healthcare funding in both the public and private sector is headed towards a sustainability crisis, delegates at this year’s Hospital Association of South Africa (HASA) conference heard. But potential solutions such as pooling resources, linking services and partnering smarter has proved to be elusive and far from simple to implement.
The conference was held against a backdrop of ongoing legal action brought by HASA in March this year opposing the passing of the National Health Insurance (NHI) Act. As previously reported by Spotlight, this is one of eight challenges to date against the Act since it was signed in May 2024.
HASA’s case centres on the affordability of NHI and its potential impact on the private healthcare sector.
Dr Dumisani Bomela, Chief Executive Officer of HASA, wrote on their website in September: “Government must view private healthcare as a strategic partner, a national asset that can offer significant ideas to resolve the national health delivery crisis. Private healthcare, on the other hand, faces challenges, some of which were identified in the Health Market Inquiry.”
The final report of the Competition Commission’s Health Market Inquiry was published in 2019, but as yet, most of its recommendations to bring private healthcare costs under control have not been implemented by government. Most medical aid schemes recently announced well-above-inflation increases for 2026 – such above inflation increases have been the norm for over a decade.
In February this year, government took what appeared to be a first step toward getting a grip on private sector healthcare costs when it published draft regulations that would, among others, have set up structures to facilitate tariff-setting. The way these structures were to be set up (a block exemption from the Minister of Trade, Industry and Competition was used to create new structures in the national health department) however raised questions about how well thought-through the plan was. This week, Department of Health spokesperson Foster Mohale told Spotlight that “stakeholders rejected the regulations and the legal opinion was that the draft regulations conflated roles so must be redrafted”. He said the department is busy drafting a new regulation that will work in tandem with a block exemption.
“Not only has the country spent nearly two decades in a fruitless debate about the NHI, but it appears that those in charge of the healthcare system have prioritised stagnation over progress in health reform,” Bomela wrote in September.
Last year’s HASA conference made headlines when an alternative to NHI was proposed that would, among others, see medical scheme membership be made compulsory for people earning above certain thresholds – a move it was argued would swell medical scheme membership, bring down the cost of scheme membership (through younger and healthier people joining), and reduce pressure on the public sector by diverting millions of people to the private sector. While there was some engagement with the Presidency on the proposal and it seemed for a while that there might be some flexibility on the design of NHI, the ANC eventually rejected the idea that any concessions would be made on the design of NHI. Since then, some draft regulations relating to the NHI Act have been published for public comment. Even though it is widely acknowledged that NHI is a long-term project, indications are that government intends to continue on the course set out in the NHI Act.
Better ways to pay for healthcare?
The two-day conference in Sandton this year again included speakers’ take on alternatives to NHI and ways to reform how healthcare is paid for. There was also discussion of the opportunities to leverage advances in artificial intelligence, the use of targeted therapies to remove more of the hit-and-miss of treatment plans, and better use of centralised data to speed up accurate diagnosis and be more helpful to patients in navigating the healthcare system.
At the same time though, speakers reiterated the urgency to break from the trap of talks that don’t come with action and for public-private collaborations to start delivering for more people. Several speakers did not mince their words when describing the scale and depth of the country’s healthcare crisis.
“Healthcare in South Africa is broken, in fact, it is in crisis. We are witnessing, if not participating in, the quickening implosion of our health system,” said Dr Biancha Mentoor, a health policy manager at Netcare.
“While predicting great strategy, we are just rearranging the deck chairs on the Titanic.”
In her address, Mentoor singled out poor leadership “that is out of touch with the people it is supposed to serve” as one of the biggest stumbling blocks.
“We see more homogenous leadership demographically, and it’s leadership with a preference for more established ways of thinking about and doing things in a country facing different challenges,” she said.
Mentoor’s “alternative” tackled the need for greater diversity in leadership, including gender diversity and intergenerational diversity. She also called for private sector players to organise better and be better aligned for effective cooperation.
The Western Cape mapping project
Conference delegates also heard of a collaborative project in the Western Cape that is showing some promise. Actuary Barry Childs, from Insight Actuaries & Consultants, and Suzanne Daniels, deputy director for compliance, billing systems, training and costing in the Western Cape Health Department co-presented on their work done in the Western Cape to map data, streamline data collection, and improve data analysis in order to establish diagnosis-related group (DRG) costing models as envisaged under NHI. They mapped four years of financial data from major hospitals and used this to inform the next steps for refining cost estimates and to have better case mix comparisons.
A DRG payment approach is a reimbursement model for hospital services to determine fixed fees to be paid for treatments. It categorises patients into groups based on diagnosis and the procedures and treatment patients will typically need. It is meant to be a way to standardise payments and to control costs. Unlike with a fee-for-service model, where a fee is paid for each consumable and service delivered, DRGs aim to set a flat rate for an entire treatment. Under a DRG model there might for example be a flat rate for a vaginal delivery, whereas under a fee-for-service model costs will depend on factors such as which scans were ordered and how many consumables were used in a particular case.
Daniels said: “One of the pillars to this is quality care and one of the pathways to quality care is understanding our healthcare cost, because in doing so, we can inform equitable resource distribution, and this is to guide efficiency measures.”
Childs warned though that time is being wasted. He said he had worked on versions of a DRG roadmap since around 2010, pointing out that the long limbo continues to keep the ideals of universal healthcare from being realised.
“This has been under discussion for a long time, and unfortunately, at a national level, the overall focus has been on NHI Act and NHI Bill and very little reform has been done on the ground,” he said.
Childs and Daniels said their showcase of the successes and insights from the Western Cape mapping project could offer other provinces a guide to get out of the starting blocks in standardising procedure and hospital codes, collecting better data and getting a clearer grip on costs and grouping of costs in order to move towards better healthcare funding reforms.
A model that’s working at one Gauteng hospital
Ahead of the conference, Spotlight spoke to group chief executive of Life Healthcare, Peter Wharton-Hood, about the company’s partnership with the Gauteng Department of Health. The partnership involves Eugene Marais Hospital (a Life hospital) taking oncology patients from Steve Biko Academic Hospital (a state hospital).
This comes in the context of the Gauteng health department being taken to court by the Cancer Alliance in a drawn-out legal battle to compel the department to review and update the waiting list of cancer patients in the province and also to draw up and submit to the courts their plans on how they intend to ensure cancer treatment for people who need it. This includes partnerships with the private sector. (See our previous reporting on the litigation here)
Wharton-Hood said they are not informed whether or not the patients they receive are on the Gauteng department of health’s cancer waiting list or backlog list.
However, to date only 34 patients from the public sector have benefitted with this diversion programme at Eugene Marais, with another 10 people about to start treatment. Wharton-Hood said it could and should be many more patients.
“We’ve got a whole care pathway that is up and running. The treatment protocol follows the national guidelines, so there is no compromise to care. The patients are integrated into the daily schedules running in the hospital. And government is also paying us on time. This is a model that is working, so the question is why only 34 patients? We can do more,” he said.
He added that the public and the private health sector represent two vital assets and if they worked together more patients could benefit. However, as it stands, the full potential of these partnerships is simply not being harnessed.
Wharton-Hood said there continues to be a peculiar government reluctance to buy more services from the private sector. It could be win-win-win deals, he said. For the state, it would ease congestion and backlogs at state hospitals. For private facilities, it would push up optimal utilisation and boost revenues. For patients, it would be treatment and care with fewer delays.
He added: “We’ve got something that’s working with Eugene Marais Hospital taking oncology patients from Steve Biko Academic Hospital. It should be a model that is scaled up and applied to other disciplines. If it’s good for oncology, it could be applied to renal dialysis or to orthopaedic cases, for example. The question is why this isn’t the case, why is government not entering into more of these deals when there are people we know are not getting the care they need?”
#InsideTheBox is a column by Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. (Photo: Supplied)
By Andy Gray
In several countries, the public is given an opportunity to share their views with regulators before new medicines are registered or to engage with those choosing essential medicines. In South Africa, however, opportunities for such public participation remains limited. In his latest #InsideTheBox column, Dr Andy Gray takes a look at how public participation is handled elsewhere and how it could be improved here.
One of the rallying cries of patient and community-based organisations has long been “nothing about us, without us”. The “patient voice” is, however, not always heard in medicines selection or medicines regulation.
How it works in the US and Europe
Recent highly contested medicines regulatory decisions in the United States, such as the warnings about paracetamol use in pregnancy, have highlighted the role of advisory committees to the Food and Drug Administration (FDA). The FDA relies on a number of such committees to provide advice on regulatory questions, such as whether to approve a new medicine or how to manage emergent safety signals. The FDA usually follows the advice provided by these independent structures, but is not bound to do so.
The fact that advisory committees meet in open session, and that their recommendations are transparent to the public, means that the final decision by the FDA can be contrasted with the scientific advice. The curricula vitae of advisory committee members are posted on the FDA website and updated annually. Critically, when an advisory committee meeting is scheduled, the date and time is announced at least 15 days in advance of the meeting, and this serves as an invitation to interested parties to register to make oral submissions during the Open Public Hearing portion of the meeting.
In addition to providing opportunities for public engagement in this manner, the FDA has also operated a Patient Representative Program since 2024. FDA Patient Representatives are appointed, provided with training, and may then engage with the scientific and other expert members of the advisory committees. Among the criteria applied in their selection are personal experience with a particular disease as a patient or primary caregiver, knowledge about the treatment options and research in that area, and the willingness and ability to communicate in public, as well as being objective while representing the concerns of others affected by the disease.
Similar mechanisms have been put in place in Europe. The European Medicines Agency (EMA) has enabled the appointment of patients as members of its management board and scientific committees. In addition, the EMA Patients’ and Consumers’ Working Party provides a venue for ongoing engagement. The EMA engagement framework explicitly aims to ensure “access to patients’ real-life experiences of living with a condition, its management and the current use of medicines, complementing the scientific evidence provided during the evaluation process” and “the generation, collection and use of evidence-based patient experience data for benefit-risk decision-making”.
How it works in South Africa
Section 3(9) of the Medicines and Related Substances Act, 1965, instructs the chief executive officer of the South African Health Products Regulatory Authority (SAHPRA) to appoint advisory committees. The wording is peremptory, but also broadly enabling: “The Chief Executive Officer shall, in consultation with the Board, appoint committees, as he or she may deem necessary, to investigate and report to the Authority on any matter within its purview in terms of this Act.” Provided there is consultation with the Board of the Authority, the number of committees and their membership is left to the CEO to decide.
To date, however, there has been no deliberate effort to include patient or consumer representatives on any of the advisory committees.
More importantly, meetings of the committees are not open to the public, nor are their recommendations to the regulatory authority placed in the public domain. The “patient voice” is therefore potentially missed, and stakeholders are unable to determine when or how final decisions taken by the Authority may differ from the recommendations made by the technical advisory committees. In that sense, SAHPRA is no more transparent than its predecessor the Medicines Control Council, which also laboured under the same antiquated secrecy provision in the Act. Section 34 of the Act is actually labelled “Preservation of secrecy”.
Similar concerns with medicines selection
Medicines regulators determine whether medicines should be allowed onto the market and how those should be controlled. Similar dynamics are at play in determining which medicines are “essential” and should be procured or reimbursed by health systems.
At a global level, the World Health Organization (WHO) updates its Model List of Essential Medicines every two years. The Model List is a starting point for many countries’ efforts to develop national essential medicines lists, guiding procurement in their public sectors. Although the expert committee responsible for this work does not explicitly include patient representatives, all proposals submitted are placed in the public domain, as are the reviews conducted, and an account of the final decisions. On the first day of the meeting, an open session is held at which stakeholders are invited to apply to present.
One of the most trusted medicine selection bodies is the UK National Institute for Health and Care Excellence (NICE), which also has a deliberate process for stakeholder engagement at multiple steps in its guideline development. For example, right at the outset, this invitation is issued: “NICE invites all stakeholder organisations to attend a scoping workshop. You will be sent a first draft of the scope, which will be discussed at the meeting. We encourage you to send someone who knows about and can represent patients and carers’ interests.”
Medicines selection in the South African public sector is evolving, embracing the challenge of health technology assessment. While there are as yet no patient representatives on either the Expert Review Committee or the National Essential Medicines List Committee, there are opportunities for stakeholder engagement with draft guidelines and increasing transparency, with medicines evaluation reports posted on the Department of Health website.
Full medicine reviews follow an evidence-to-decision framework that was first piloted during the height of the COVID-19 pandemic. One of the questions posed reads: “Is there important uncertainty or variability about how much people value the options?” This question is aligned with what the WHO Handbook for Guideline Development refers to as “values and preferences”. For example, the WHO guidance calls for evidence of the “values and preferences of the people receiving the intervention or experiencing the outcomes the intervention can affect”. While that evidence may sometimes be reported in the scientific literature, all too often it is lacking.
Ultimately, “nothing about us, without us” should not only be a demand made by patients, but also by those who care about the quality, reliability and acceptability of medicines selection and regulatory decisions. Improving the transparency of decision-making processes is critical, but so is creating, promoting and protecting the spaces for an effective “patient voice”. Doing so is a critical investment in building trust, which is so easily eroded.
*Dr Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is part of a series of #InsideTheBox columns he is writing for Spotlight.
Disclosure: Gray is a member of South Africa’s National Essential Medicines List Committee and co-chairs its Expert Review Committee.
Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.
