Tag: Spotlight

Categories : TransplantsTags :

SA has Very Low Organ Donation Rates – How Can We Fix it?

On By ModernMedia
The country that performed the first successful heart transplant has very low organ donation rates. Now a student-run medical non-profit is hoping to make a difference. (Photo: Nasief Manie/Spotlight)

By Elri Voigt

Thousands of people in South Africa are waiting for a life-saving organ transplant, but our very low organ donation rates mean that many won’t get a transplant in time. Spotlight asks the experts why our donation rates are so low and what can be done about it.

Back in 2002, Rentia le Roux received a horrifying diagnosis that her kidneys were failing. “My kids still need me, they are still small, what are we going to do?” Le Roux recalls telling her doctor. After a long journey trying to manage her kidney failure, she would eventually get a kidney from her sister in 2011.

Le Roux, now the chairperson of the Western Cape Transplant Sports Association, is one of the lucky ones. She spoke to Spotlight ahead of a trip to Germany to take part in the 2025 World Transplant Games.

“There are so many people that are on the list waiting for an organ and the waiting period, it can take many years,” she says.

Incomplete data

While there isn’t a coordinated, centralised database of everyone in South Africa who needs a lifesaving organ transplant, various groups do collect data. This is according to Professor David Thomson, an abdominal transplant surgeon and a critical care sub-specialist. Thomson is also the head of the Transplant Centre of Excellence Project at Groote Schuur Hospital in Cape Town.

“Various entities do collect levels of data, but it’s not very centralised and coordinated, and it could be better…we do have the renal registry that’s trying to track the number of people on dialysis, that’s a good source of information,” Thomson says. The Renal registry is a not-for-profit database that collects and publishes data on dialysis and transplant patients in the country. The database itself is an initiative of the South African Nephrology Society, an NPO that aims to further the field of nephrology and improve patient care.

The society estimates that in 2022, just over 9000 people across the public and private healthcare system were receiving “kidney replacement therapy” – which were either medications to help kidney function, dialysis or a kidney transplant.

A report by the South African Transplant society, an NPO that seeks to advance tissue and organ donation and transplantation, estimated that in 2021, across South Africa’s private and public hospitals, 2 586 people were on a waitlist for a lifesaving organ. Of those, 2382 people were waiting for a kidney, 52 needed a liver, 108 needed a heart transplant, and 44 were waiting for a lung.

But in the same year, the report recorded only 229 transplants done across the country.

South Africa does not have a good organ donation culture, says Professor Mignon McCulloch, the head of paediatric nephrology and solid organ transplant at the Red Cross War Memorial Children’s Hospital. In fact, according to McCulloch, and other experts we spoke to, South Africa has some of the lowest transplantation rates in the world.

While we couldn’t find any straightforward ranking system of organ donation rates, reports by the Global Observatory on Donation and Transplantation (GODT) do provide some insight into how some countries compare to one other. In 2017, according to data from the GODT cited in this 2020 study published in the South African Medical Journal, South Africa had 91 deceased donors, which is a rate of 1.6 per million. By contrast, Spain, which is regarded as having one of the highest rates of organ donation in the world, had 2183 deceased donors, a rate of 47.05 per million.

How it works

Organ donation is broadly classified into living donation and deceased donation.

There are two scenarios where someone can become an organ donor. The first, Thomson explains, is when a healthy person donates an organ without which they can live a normal life, like one of their kidneys. The second is when someone has been declared brain dead and is on a mechanical ventilator or when someone has experienced circulatory death -meaning their heart has stopped beating and “futile non-beneficial treatments have been stopped”. The latter is less common in South Africa.

For deceased donation from a brain-dead patient to take place, the potential donor needs to be in an ICU facility on a mechanical ventilator and referred by their clinical team to a transplant coordinator, says Thomson. If that person is eligible, then the transplant team has to get permission from the next of kin who ultimately have the final say even if the potential donor is registered as an organ donor.

“Organ donation can only happen if someone is on a mechanical ventilator in the end-of-life care pathway, so that is always a complicated and emotional discussion,” he says. “Tissue donations such as corneas, bones, skin, that can happen at the mortuary afterwards and there’s a slightly longer period for when these can be successfully recovered but all donation still requires you to have conversations with and get permission from grieving families.”

Juggling resources

McCulloch describes organ donation as being a bit like “a silent Cinderella”, until someone needs a lifesaving transplant, “and then people suddenly start asking questions about why, why don’t we have more transplantation?”

One reason for this is the allocation of resources and competing priorities within the healthcare system.

Thomson says that organ transplants are a “health intensive resource”, and it’s important to acknowledge that it exists in the context of an already overburdened healthcare system. There is a Deputy Director of dialysis and transplantation within the National Department of Health, Thomson explains, but there isn’t an “overarching central coordinating authority supporting deceased donation”. Instead, he says it is driven by hospital groups and within the provincial healthcare departments by healthcare workers

Adding to this, McCulloch says that doctors are always having to “juggle resources” and if there is only one bed available in an ICU, weighing up whether to give it to someone who will potentially become an organ donor or someone with pneumonia and will likely have a good outcome, is difficult.

Another challenge is the limited number of surgeons, physicians, and hospitals with the skill and equipment to perform an organ transplant. This strategy roadmap document by the South African Transplant Society list 21 transplants centres across the whole country – 14 of them offer kidney transplants, six offer heart transplants, four offer lung transplants, four offer liver transplants, and only one offers pancreas transplants.

Graphic of transplant centres in South Africa. (Source: Organ and Tissue Donation in South Africa – Creating a National Strategy Roadmap)

One can save seven

Earlier this year, an unused room in Tygerberg Hospital got a face-lift and a new purpose from a student-run medical non-profit. The initiative called Save7 was kickstarted by a conversation on kidney donation on Stellenbosch University’s Medical Campus. Its initial goal was to raise awareness, particularly among students, that one donor can save up to seven lives. And if tissue like corneas, heart valves, bone and skin are donated, one person can improve the lives of around 50 people.

Jonty Wright, who cofounded Save7, tells Spotlight that the organisation’s founding group of four has now grown to over 200 across multiple universities countrywide. Among others, the group created a Lifepod to solve a transplant-related problem at Tygerberg Hospital. Doctors and staff involved in transplantation at the hospital were citing competing resources as the reason behind low referral rates of potential organ donors by healthcare providers.

The solution posed by Save7, professors on the campus and some of the doctors involved with transplantation was to create a designated bed space for patients who are brain dead and are potential organ donors. The hope was that referrals for potential organ donations would be increased.

The room, Wright says, was an old minor operating theatre and storeroom that belonged to the orthopaedic surgery department and was situated in an ideal spot – in a corridor between the emergency medicine and trauma admissions.

Three of the Save7 co-founders, from left to right Jonty Wright, Suhayl Khalfey and Sachen Naidu. (Photo: Nasief Manie/Spotlight)

About three months ago, after fundraising efforts and backing by the Health Foundation and other partners, the Lifepod opened. The room currently holds a hospital bed, a ventilator on lease from the surgical department, vitals monitor, cardiac monitor, infusion pumps, emergency trolley, fridge, and crash cart. All the things needed to keep someone who is brain dead’s body comfortable and allow the doctors to counsel their loved ones about potentially donating their organs.

So far, according to Wright, referrals of potential candidates for organ donation at Tygerberg have gone up by 500%, but at the time of the interview none of the next of kin have consented to donating their loved one’s organs. (Data on this has not yet been published).

This ties onto another layer of complexity around organ donation, the reasons why next of kin don’t always give permission.

Need for better education

Samantha Nichols, the executive director of operations for the Organ Donor Foundation, an NGO advocating for organ donations, tells Spotlight that the problem isn’t so much a lack of awareness of organ donation, as a lack of good education around it. She says this affects everyone, including healthcare workers.

Nichols says that “it’s almost like the stars have to align” for a deceased donor to donate their organs, because of how many steps and doctors are involved in the process.

“[W]hen a person is sent to an ICU or trauma unit, the team of doctors that work on that person to save their life is a totally different team to the transplant team,” she says. A transplant team is only ever called in if a potential donor has been declared brain dead by two different doctors who aren’t part of or affiliated with a transplant team.

“[O]nly then can they start the process of talking to the family, and then they still need to get consent from the family before the organs are removed,” she says.

The Opt-in versus Opt-out debate

When it comes to consent for organ donation, South Africa has what is referred to as an opt-in system. An opt-in system means that someone must provide explicit consent of their desire to donate an organ. While an opt-out system means all adults are automatically considered organ donors after death, unless they explicitly withdraw consent beforehand.

There has been some debate about whether switching to opt-out systems would improve organ donation rates. One recent study, in which researchers analysed deceased donor rates in five countries that had switched from an opt-in to an opt-out system, did not find an increase in organ donation rates.

“Unless flanked by investments in healthcare, public awareness campaigns, and efforts to address the concerns of the deceased’s relatives, a shift to an opt-out default is unlikely to increase organ donations,” the researchers concluded.

A 2024 editorial in the Lancet medical journal made a similar point, saying “a simplistic switch to the ‘opt-out’ model is alone not sufficient to boost donation”. Instead, it lists the three components that makes Spain’s transplant programme so successful. “A solid legislative framework, strong clinical leadership, and a highly organised logistics network overseen by the National Transplant Organization.” An opt-out system is also unlikely to work well in South Africa from a legislative perspective, since it might be seen by some to impinge upon an “individual’s rights to personal autonomy and bodily and psychological integrity”, as argued in this article in the Conversation.

The experts Spotlight spoke to instead point to several other changes that could be made to improve donation rates.

‘Everyone can do a bit better’

The responsibility around improving organ transplantation rests on us as society and as a coordinated healthcare system, according to Thomson.

“[E]veryone can do a bit better…and I don’t think you want to make it one person’s responsibility for the performance. It’s actually a collective and how we work together,” Thomson says. “…a lot of things like supporting donation actually links into good palliative care services, and that should be something we’re offering to everyone.”

Thomson advocates for upskilling healthcare workers to be able to better counsel families during end-of-life care, not necessarily just around organ donation but around “engaging humanely with “families and end of life and navigating that complexity with them as the healthcare team”.

He recommends making counselling of grieving families and palliative care discussion a hospital system issue, instead of an individual responsibility by adding it to institutional operating standards. “And then you actually need to audit it, measure it, reflect on it and monitor the outcomes,” he says.

Suhayl Khalfey, a Save7 cofounder, says now that the Lifepod is ready to use, their focus is shifting to educate people about the importance of organ donation. As part of its education efforts, Khalfey says Save7 is putting together a database of different religious leaders to help counsel families uncertain about their faith’s stance on organ donation.

Nichols stresses that transplant teams will honour different religious beliefs and funeral practises and that a donor’s body will not appear disfigured in any way after they’ve donated their organs.

Start by having the conversation

Anyone can register as an organ donor with the Organ Donor Foundation, says Nichols. The process is free and will take less than a minute (see their website here). If a situation arises where you are brain dead and you are a candidate for organ donation your family will still need to give permission.

This is why it is so important to have the conversation with your loved ones about what your wishes are, says Khalfey.

Sachen Naidu, another cofounder of Save7, adds to this saying that often with the students they’ve spoken to, organ donation is viewed as something to think about in the distant future. He encourages young people to reconsider this mindset.

Even children can learn about organ donation.

The non-profit organisation Transplant Education for Living Legacies (TELL) recently launched an educational campaign in South Africa aimed at children in the 5 to 11 age group. The initiative, called the Orgamites Mighty Education Programme, is an international child health education programme originating from Canada. At its heart, the programme is a conversation starter, says Thomson who spoke on a TELL webinar.

“All we want is for people to be having educated conversations about it [organ donations],” he says. “Children need transplants too.”

For McCulloch, organ donation goes beyond impacting just the recipients. She uses the example of families who have lost a child in a tragic accident.

“You had a completely well child five minutes ago and then something terrible happened, and now you’ve got a child who’s died and you’re going to go home with a gap in your heart. Whereas at least when you donate [the] organs to another child, something good can come of out of a really hopeless, tragic situation,” she says.

Thomson adds to this saying: “And that’s a memory that lives with that family for a long time afterwards …not just that time point. That’s what they’re going to remember as part of that event, and it really does offer them a degree of solace for a tragedy.”

And the difference to those receiving organs can obviously be life changing. Receiving a kidney gave Le Roux the chance to see her children grow up. “So, every [milestone] when they wrote matric, when they got their degrees, everything. It’s like a step forward, something I can tick off, I’m still here. I’m able, I’m healthy,” she says.

Republished from Spotlight under a Creative Commons licence.

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Categories : HIVTags :

Response to Aid Cuts and HIV Prevention Injections Dominate Discussions at SA AIDS Conference

On By ModernMedia
Photo by Sergey Mikheev on Unsplash

By Ufrieda Ho

A dire picture for HIV/Aids funding emerged at the 12th South African AIDS Conference, raising the call for resilience, adapting and also for government to raise its game.

The what-next of South Africa’s HIV response will have to be centred on getting back to basics, leveraging on advances in treatment options and learning fast about adapting in a world without US aid for health services.

These were among the key takeaways from speakers at a plenary session at the 12th Southern African Aids Conference held in Kempton Park last week.

Professor Linda-Gail Bekker, executive officer of the Desmond Tutu Health Foundation, in her address took stock of “the incredible devastation around the world” from the virtual overnight shutting off of funds and human resources as Donald Trump returned to the US presidency in January 2025.

“It was $460 million into the wood chipper for us. And the worrying thing is that it could take us back to the harrowing scenes of 2000 [the height of Aids deaths in the country],” she said.

This comes against what she called the two largest challenges for South Africa’s HIV response: sub-optimal 12-month retention in care and viral suppression. Meaning the struggle to keep patients on treatment beyond a year and helping them stay on antiretrovirals that reduce the amount of virus in the body to a minimum.

The picture painted by Bekker and others is bleak, with much uncertainty remaining as to how South Africa might plug the funding holes left by the abrupt US aid cuts.

Bekker shared research by the Health Economics and Epidemiology Research Office (HE²RO), a division of the Wits Health Consortium at the University of the Witwatersrand. Their research shows that the fallout in the next three years could see South Africa experience a 29% to 56% increase in new HIV infections, or an additional 150 000 to 295 000 cases by 2028. Unless the South African government is able to take over services, there could be a 33% to 38% increase, or an additional 56 000 to 65 000 AIDS-related deaths in that period. (Spotlight previously reported on the HE²RO modelling in more detail here.)

The modelling also suggests that government will need additional funding of between $620 million and $1.4 billion (roughly R10 billion to R24 billion) between 2025 and 2028 to replace the local services that received US government funding.

In July, Treasury allocated R763 million in emergency funding to fill the gap, a fraction of what the HE²RO researchers estimate is needed. In addition, the Gates Foundation and the Wellcome Trust pledged R100 million each for research to the South African Medical Research Council on condition that the South African government doubled their contributions, which government committed to over three years. This added up to an R600 million bailout for research, also a fraction of the amount of research funding that has been lost.

The shortfall remains massive. Last year, Pepfar (United States President’s Emergency Funds for AIDS Relief) funds flowing to South Africa totalled over R7.5 billion.

Calls for greater transparency

Throughout the conference, there was also strong calls from attendees and speakers for government to be more transparent about its plans to mitigate the funding cuts and to provide credible data and information about monitoring and measuring of the success of their interventions. This includes details on how it plans to provide all stable patients with enough medicines for six months at a time. Such multi-month supplies mean people have to travel less to collect medicines, thus making it easier to stay on them. Rollout of multi-month dispensing has been very uneven across the country.

Questions were also raised over a lack of full transparency regarding the price of lenacapavir, a breakthrough HIV prevention injection that provides six months of protection per shot. As we recently reported, the South African government will be paying $60 per person per year for the jab, with other donors paying the rest – it is not publicly known how much this “rest” is. The deal was setup by the Global Fund to Fight AIDS, Tuberculosis and Malaria, Gilead Sciences – the company that makes lenacapavir – and several private donors. Last week, Spotlight published an op-ed in which activists questioned the lack of full transparency about the price.

Dr Sandile Buthelezi, director-general for the National Department of Health, told attendees about the possibility of bringing forward the rollout date for lenacapavir from April next year, to possibly as soon as November this year. He did not answer questions about the price negotiations. He did however confirm that negotiations with The Global Fund has seen them commit to ringfencing US$29 million for procurement of lenacapavir over the next two and a half years.

Doing more with less

Having to do more with less, Bekker said at the conference, will mean the need to build a “resilience bridge”. For her, this means preserving the “two most important interventions” of providing continued access to antiretroviral treatment and to HIV prevention treatments – both long-acting injections and prevention pills.

She added that it also means better efforts to reach the population of people living with HIV who have been diagnosed but are not on treatment. In February 2025, government launched its ‘Close the Gap’ campaign aimed at placing an additional 1.1 million people on treatment by the end of this year. Bekker said the number of people living with HIV who are not on treatment is closer to 2 million people. According to Thembisa, the leading mathematical model of HIV in the country, of the roughly eight million people living with HIV in South Africa, around 6.2 million are on treatment.

How South Africa is progressing against the 1.1 million target is not clear. Figures previously shared by Health Minister Dr Aaron Motsoaledi indicated that over half a million people had been initiated on treatment in a matter of months. This raised eyebrows since, on the face of it, it means that people had been started on treatment this year more quickly than at any other time in South Africa’s HIV response. It also wasn’t clear whether the number of people who had stopped treatment had been subtracted from the number starting treatment. Questions Spotlight previously sent to the health department seeking clarification of the numbers went unanswered. Similar questions were also raised in an open letter and an op-ed published by Spotlight and GroundUp. As yet, Spotlight has not seen answers to the questions raised about the numbers shared by the Minister.

“We need to make services [more] amenable to retention so it means multi-month dispensing and differentiated care,” Bekker said. Differentiated care refers to treating people differently based on their needs – for example by not requiring healthy people living with HIV to visit the clinic as often as sicker people.

“Bad policies that reflect ideology and bias, mean the most vulnerable are deterred from assessing the services they need, and this includes our key populations,” she added of the challenges that people like sex workers, members of the LGBTQI+ community and people who use drugs face in clinics where they are judged, harassed or discriminated against.

Dr Lise Jamieson, a senior researcher at HE²RO, echoed Bekker’s sentiments and said a first priority remains to arrest any backsliding of care as South Africa restructures its HIV programme to match the money it has currently. “It is clear that the one thing that we absolutely cannot drop is our HIV treatment programme – it saves lives,” she said.

For Yvette Raphael, the co-founder and co-director of Advocacy for the Prevention of HIV and Aids (APHA), the undergirding socio-economic factors that have given HIV its stranglehold in South Africa remain largely unchanged.

She said: “I am one of the people who are ageing with HIV and suffering from other non-communicable diseases that come with this”, highlighting the need to address the evolving nature of HIV in the country and the need to address it alongside conditions such as diabetes and heart disease.

But she added that it is still teen girls and young women who are at a disproportionately high risk of acquiring HIV. Her message was for better youth-targeted responses that are community-level responses not top-down strategies.

“Make HIV a priority sustained by local and district government structures, not up here in our national and province centres,” she said.

“Make HIV prevention harder to ignore and weave HIV intervention services with skills training and income generating programmes. We know that employment in this country is low, so young people cannot be expected to continue a healthy life without spaces where they can generate income for themselves, this will [in turn] reduce their vulnerability and dependency on older men.”

She added that government had to step up to what should always have been their role as Pepfar funding was never meant to substitute the work of government. Raphael said: “Pepfar was here to support the government in the early days of HIV. However, some of our government officials saw that as a way of evading their responsibility, and we are now here.”

Note: The Gates Foundation is mentioned in this article. Spotlight receives funding from the Gates Foundation, 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.

Republished from Spotlight under a Creative Commons licence.

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Categories : Ethics and LawTags :

EDITORIAL | The Rot Runs Deep: Gauteng Health’s Dance of Impunity Betrays the People It Is Meant to Serve

On By ModernMedia
Photo by Tingey Injury Law Firm on Unsplash

Spotlight Editors

The courts have spoken. The health ombud has issued devastating reports. The Auditor-General has again put damning evidence on the table. Civil society has protested. Yet, the devastating crisis in Gauteng’s health system shows no sign of improvement.

The rot in Gauteng appears to be deepening. Nowhere is this more evident than in the province’s health department, which remains trapped in a cycle of institutional decay and administrative failure.

The consequences are catastrophic, with real and devastating impacts on lives and the delivery of essential health services.

A case in point is the department’s failure to provide life-saving treatment to cancer patients. In a stunning rebuke, a high court found this failure unlawful and unconstitutional. Rather than comply with its constitutional obligations, Health MEC Nomantu Nkomo-Ralehoko and the health department chose to appeal the judgment to the Supreme Court of Appeal.

Making matters worse, a second high court ruling ordered the department to implement the original judgment. And yet again the department is appealing.

Jack Bloom, a DA MP in Gauteng, suggests that the MEC and the department is fighting so hard because they may eventually be held accountable in a case he says evokes the horrors of the Life Esidimeni tragedy. Bloom may have a point.

The background is dismaying.

Prior to the recent court rulings on cancer care, sustained pressure from activists had helped the department secure a R784 million budget for outsourcing radiation oncology services. But the department returned the first tranche of R250 million to Treasury unspent.

At last count in 2022, more than 3 000 patients were on a waiting list for treatment. Many of them would by now have lost their lives. Others may still be alive, but the optimal time for them to get radiation therapy may have passed and their chances of survival are thus substantially diminished.

That R250 million meant to help these desperate people and families simply went unspent boggles the mind.

It is no doubt too late for many, but there are at least some limited signs of progress. While the department has not been answering Spotlight’s questions, Nkomo-Ralehoko has indicated in the Gauteng legislature that a significant number of cancer patients are being treated with the help of private sector facilities. That the MEC and the department is nevertheless challenging the high court ruling, much of which is a demand for greater transparency, suggests that they know they have at best taken several more steps back than they have taken forward.

Unfortunately, none of this feels new.

For well over a decade, Spotlight and other media have reported on a persistent pattern of institutional breakdown and failed leadership in Gauteng’s public healthcare system. Among the most shocking examples are the Life Esidimeni tragedy, the assassination of whistleblower Babita Deokaran, and the state’s sluggish response to the corruption she exposed. Questions continue to swirl around an impasse over a critical agreement with Wits to bolster healthcare services, senior appointments in the department and the selection of hospital CEOs. The fire at Charlotte Maxeke Johannesburg Academic Hospital and the lack of urgency in restoring services there further underscores the dysfunction. So does the persecution of whistleblowers like Dr Tim de Maayer, and the damning Health Ombud report into conditions at Rahima Moosa Mother and Child Hospital.

And that’s just the tip of the iceberg. Years of chaos in hospital security contracts, questionable food procurement practices, and the department’s failure to supply adequate colostomy bags to patients — the list goes on and on.

Add it all up and it is clear the rot runs very deep.

The reason for this is no mystery. The Gauteng health department has an annual budget of around R67 billion. This is more than 20% of the South African government’s entire spending on health. For the corrupt, the Gauteng health department is an obvious target.

And that it has been systematically targeted is not in doubt. Human rights activist Mark Heywood and Wits University Professor Alex van den Heever reckon that close to R20 billion has been stolen from the Gauteng health department over the past decade. “The scale of this theft makes former President Jacob Zuma look like a clumsy shoplifter,” Heywood writes in the Daily Maverick.

Perhaps the clearest dissection of how deep the rot goes is to be found in investigative journalist Jeff Wicks’ excellent  book The Shadow State: Why Babita Deokaran Had to Die. In it, he unpacks the industrial-scale corruption at Tembisa Hospital where R830 million was siphoned off in just four months by a network of ruthless, well-connected looters. Allegedly, one of the key beneficiaries was Vusimusi “Cat” Matlala, a businessman with a criminal record and close ties not only to ANC bigwigs but also to senior police officials.

Meanwhile, the department is also failing to pay its creditors on time. Recently, City Press reported that Gauteng’s health department was the only provincial department flagged for noncompliance across all audit areas — despite having received a clean audit opinion. Accruals now exceed R8 billion, consuming 12% of the department’s R67 billion budget. “The problems are huge,” admitted Lebogang Maile, Gauteng’s MEC for Treasury and Economic Development.

Whichever way you slice it, the harsh truth is that even in 2025, the devastating crisis in Gauteng’s health system shows no sign of improvement. Corruption still plagues the department just as severely as it did a decade ago, if not more so. In the end, it is the province’s many committed healthcare workers and the people who depend on the public healthcare system who pay the price – whether a cancer patient or someone with a stoma and in need of a reliable supply of colostomy bags.

Where to from here?

Ultimately, the person responsible for fixing all this is Gauteng Premier Panyaza Lesufi. As Premier, he appoints both the province’s MEC for health and the head of its health department. It is because of Lesufi that Nkomo-Ralehoko and head of department Lesiba Malotana are still in place, despite the havoc around them.

From one perspective, it is hard to fathom why an ambitious politician like Lesufi would stand for such gross incompetence. His party, the ANC, has after all already been severely punished at the polls – in 2024 they got just under 35% of the votes in the province. Letting the province’s already eroded health services decay further can only lead to further electoral decline.

It is of course also possible that Lesufi and those around him are being misled, or intentionally not paying much attention, to just how bad things really are. Zuma too insisted that “we have a good story to tell” even as the state capture looters were in full stride. Maybe reality will similarly catch up with Lesufi if he continues faffing about while Rome burns.

After all, the courts have spoken. The health ombud has issued devastating reports. The Auditor-General has again put damning evidence on the table. Civil society has protested time and time again and spoken out in the media. Doctors and nurses have tried to raise issues through the correct channels and have been ignored. Expert help has been offered and declined. Most damningly, whistleblowers have paid with their lives.

Disclosure: SECTION27 is involved in the cancer court case proceedings as well as ongoing efforts seeking justice for the Life Esidimeni tragedy. 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.

Republished from Spotlight under a Creative Commons licence.

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Categories : Ethics and LawTags :

On Which Legal Arguments Are the NHI Court Cases Set to Turn? Part 1: Affordability

On By ModernMedia

By Jesse Copelyn

Since President Cyril Ramaphosa signed the NHI Act into law last year in May, eight different groups have challenged it in court. One common argument is that it is irrational and unreasonable to restructure the health system when there’s no money to do so. In this feature, Spotlight dissects how the argument is being applied, and whether it has any chance of success.

Earlier this month, the Western Cape Government filed papers with the Constitutional Court challenging the validity of the National Health Insurance (NHI) Act. In doing so, it became the eighth group to litigate against the Act, which aims to provide the same state-funded medical cover for all South Africans.

Not only are there now numerous litigants, each with their own distinct set of arguments, but some have also launched multiple applications, challenging different steps that led to it becoming law.

In this context, figuring out on which legal questions the future of the NHI Act will ultimately turn is difficult. Thus, Spotlight combed through some of the founding affidavits and spoke with legal experts to get a sense of the arguments litigants are betting on. A first key argument relates to the affordability of the scheme – in part two of this series we will turn to whether the NHI leads to an unreasonable regression in health services for certain groups.

Rationality and reasonability

Section 1(c) of the Constitution of the country holds that South Africa is a state governed by the rule of law. One of the implications of this is that governments can’t simply introduce laws arbitrarily without any justification. Instead, when an Act is passed, there has to be some aim behind that legislation, and some logical reason as to why passing it would advance that aim.

In other words, laws have to be rational.

Not only this, but Section 27 of the Constitution states that when it comes to the advancement of certain social rights like healthcare, government must act “reasonably”. This is a more demanding requirement than “rationality”. It doesn’t just require that an Act be logically related to its purpose but that it is practically feasible, and that it meets a range of other criteria (for instance, costs and benefits have to be fairly weighed).

A central argument of several litigants is that the NHI simply doesn’t meet basic standards of rationality or reasonability. One of the reasons for this, they argue, is that the government is unable to finance the NHI, and thus the Act has no hope of achieving its goals.

There are at least two ways in which this argument is being advanced. The first is as part of a series of applications seeking to invalidate the NHI Act itself. The second is as part of a procedural challenge to President Cyril Ramaphosa’s decision to sign the NHI Act into law. Here, the focus is on the rationality of the President’s decision, rather than the Act.

Challenging the act itself

The first party to take legal action against the NHI was the conservative trade union, Solidarity, which launched its application in the North Gauteng High Court in Pretoria on 24 May 2024.

In its founding affidavit, Solidarity argued that for the NHI to achieve its stated aim of universal access to quality healthcare services, the “requisite level of funding” must be available to establish the NHI Fund and its various mechanisms. But according to Solidarity’s application, it has already been shown that the government is incapable of raising enough tax revenue to support the scheme.

For instance, Solidarity references the position of the Davis Tax Committee, which was a group of experts chaired by Judge Dennis Davis that used to advise the government on how it could raise money to advance various policy goals. In 2017, the committee released a 48-page report on the NHI, which found that the state couldn’t cover the full cost of the NHI unless there was “sustained economic growth”.

Solidarity stated that this, in combination with its own research, showed that the NHI simply can’t be rolled out comprehensively. Thus, there was a “complete absence of a rational relation between the means selected and the objective sought to be achieved”.

Similarly, in February, a separate challenge was brought by the Hospital Association of South Africa (HASA), which argued that the NHI should be set aside because it is “fundamentally unreasonable and therefore unconstitutional”.

HASA’s submission argued that the burden of proof lay with the government to show that the NHI was financially feasible before passing the Act. This is particularly important given that the scheme involves a radical restructuring of healthcare with potentially detrimental knock-on effects for the private sector. The government thus had a duty to show that the scheme could lead to material benefits that justified these harms.

However, HASA argues that “no recent comprehensive and accurate financial feasibility and affordability assessment was conducted” by the government before pushing through the NHI, rendering “the passing of the legislation unreasonable and irrational”.

For its part, the National Department of Health has argued in court papers that trying to work out the full cost of the NHI would be a futile exercise. For instance, the health department’s NHI lead, Nicholas Crisp, filed an affidavit in response to Solidarity which stated that “attempts to conduct a once-off accounting exercise” were “not useful”.

He said: “The outcome of such an exercise is inevitably inaccurate, misleading and does not support informed decision making for reform.” Crisp argued that this was already evident from the “extremely wide range of figures that various parties have claimed to reflect the cost of the NHI in the public domain”.

Instead, Crisp stated that the World Health Organization (WHO) had advised the department to conduct an “ongoing costing approach for specific steps of the NHI implementation process”, which is something they were already doing, he said.

Nonetheless, many of the litigants have pushed back against this, arguing that this approach still leaves us without any evidence that the NHI can be funded in the medium to long term. In its affidavit, HASA argues: “In the context of constrained public finances and very challenging economic conditions… it is wholly irrational to commence the wholesale restructuring of the healthcare sector without long-term costing, and only with short-term piece-meal analysis”.

Challenging the President’s decision

While the above applications have sought to review and set aside the NHI Act itself, a separate set of challenges has instead focused on the decision of Ramaphosa to sign the Bill into law.

Section 79(1) of the Constitution states that if the President “has reservations about the constitutionality of the Bill”, then he should refer it back to Parliament for reconsideration.

If it can be proved that Ramaphosa had good evidence that the NHI may have been unconstitutional, but signed it anyway, then his decision can potentially be overturned by a court. In this case, the NHI wouldn’t be completely invalidated and set aside, but the President’s decision to sign it into law would be. Therefore, the NHI would go back to being a Bill, and would likely need to be reworked by Parliament.

President Cyril Ramaphosa holds a copy of the NHI Act after publicly signing into law in May 2024. (Photo: GCIS)

The Board of Health Funders (BHF), which represents medical insurance companies, is one of the litigants taking this approach. In addition, the South African Private Practitioners Forum (SAPPF) has a two-part application challenging both the Act itself and Ramaphosa’s decision to sign it.

Once again, the affordability argument has been central in these cases. In particular, the BHF and SAPPF have both highlighted a number of documents that were sent to Ramaphosa before he signed the NHI Act, which they argue should have caused the President to reconsider whether the Act was affordable.

For instance, the parties note that in 2018, the Office of the Presidency received a letter from the acting director-general of Treasury which expressed several concerns about what was then the NHI Bill. One of them was that the “financial implications are not costed”. As a result of issues such as this, the acting director-general felt “unable to support the bill in the current form submitted to cabinet”.

The BHF affidavit points out that the version of the Bill that Treasury had commented on was “not materially altered” later on. It further states that the letter from Treasury “was before the president when he assented to the NHI Bill and it is unclear at this stage the basis on which the president disagreed with the views of Treasury”.

In order to properly evaluate the rationality of Ramaphosa’s decision, the applications by BHF and SAPPF have been seeking to have the full record of his decision made public. The record refers to any information he would have had before him when signing the bill into law, as well as any minutes of correspondences he had which related to the Act.

The BHF and SAPPF have already made some progress with their case. In May, the North Gauteng High Court in Pretoria ruled that it was able to review Ramaphosa’s decision to sign the NHI Bill into law, and gave the President 10 days to provide the full record of his decision to do so.

Neil Kirby, who heads the healthcare and life science practice area at Werksman’s Attorneys, which represents BHF, told Spotlight that after the ruling, “both the [health] minister and the president made application for leave to appeal that judgment which is a process that’s supposed to happen before the original judge. They also then proposed that they appeal directly to the constitutional court.”

He adds: “At this point in time the high court has taken a step back on the basis that the high court wants to wait for the constitutional court via the chief justice to see what to do about those direct applications.”

Thus, until the Chief Justice provides direction, Kirby says “everything is in limbo”.

In the meantime, the BHF has also launched a separate application at the Constitutional Court, which challenges the public participation process prior to Ramaphosa signing the NHI Act. The focus here is on the rationality and reasonability of Parliament’s consideration of the NHI Bill, which they argue failed to consider input from various parties. As with the other application, the affordability argument plays a role.

Kirby explains: “If you’re sitting in the National Assembly and you’re being asked to vote on a Bill that proposes a significant financial burden on the state in due course and you don’t have the figures in front of you to understand what that burden actually is, then you’re not in a position to say that such a thing is a good idea… It’s grounds for review based on the reasonableness and the rationality of [that] decision”.

How powerful is the affordability argument?

According to Kirby, the argument about affordability is by no means the only strong line of attack that the BHF possesses against the NHI, but it is easily one of the most powerful.

According to Dr Larisse Prinsen, a medico-legal expert at the University of the Free State, who is not involved in the litigation, the affordability argument is more likely to be successful as a line of attack against the President’s assent to the legislation (as with the BHF’s case). Though it would be unlikely to suffice on its own, she says.

Prinsen explains that if the “record shows that the President ignored massive red flags, such as the warnings by the [Davis Tax Committee] and Treasury regarding concerns about the sustainability of the NHI, unresolved costing, provincial power concerns etc., this could support the claim of irrationality in the decision-making process”.

However, she says when it comes to the legal challenges to the Act itself, the argument about affordability is less likely to be successful.

“Courts often defer where a law creates a framework with a phased roll-out and which leaves fiscal choices to later money bills,” she says. “The government might use annual appropriations or future revenue decisions or phased progressive implementation to argue the NHI scheme is in fact capable of reasonable realisation over time. This means that outright invalidation on ‘infeasibility’ alone is a harder battle to fight.”

Similarly, another attorney who is also independent of the litigation, told Spotlight that rationality reviews are typically aimed at procedural steps in the formation of an Act. Thus, the challenge to the President’s decision to sign the law, would likely carry more weight, he said.

Note: In part two of this series, we will turn to whether the implementation of NHI, as set out in the NHI Act, will lead to an unreasonable regression in health services for certain groups.

Republished from Spotlight under a Creative Commons licence.

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Categories : HIVTags :

Twists and Turns in the Race to Be SA’s First Widely Used HIV Prevention Injection

On By ModernMedia
Photo by Miguel Á. Padriñán

By Catherine Tomlinson

The health department has plans to roll out lenacapavir, a twice-yearly HIV prevention injection, in a select group of public sector clinics by April 2026. Meanwhile, little progress has been made towards rolling out a two-monthly prevention injection, despite the four-year head start this product had on lenacapavir.

Injections that provide months of protection at a time against HIV infection have been hailed by several leading experts as game-changers with the potential to help end the HIV epidemic.

The two antiretroviral-containing injections leading the field are long-acting cabotegravir (CAB-LA) and lenacapavir. Both have been shown to effectively eliminate the risk of contracting HIV in large clinical trials. The main difference between the two shots is that CAB-LA provides two months of protection at a time, while lenacapavir provides six.

CAB-LA captured global attention back in 2020 when pivotal trial results showed that the two-monthly injection was more effective than daily prevention pills in preventing HIV infection. Lenacapavir was thrust into the spotlight four years later in 2024 when two large trials demonstrated that the twice-yearly injection provided almost perfect protection against HIV.

There are still no clear plans for providing CAB-LA in South Africa’s public sector clinics, despite the four-year head start that it had on lenacapavir. By contrast, lenacapavir injections could be available in some select public sector clinics by April of next year, according to reporting by Bhekisisa.

How CAB-LA fell behind

In July 2022, the World Health Organization (WHO) recommended CAB-LA as a tool to prevent HIV and by December 2022 it was registered for use in South Africa.

In February 2023 though, South Africa’s National Essential Medicines Committee stated that it could not recommend the use of CAB-LA in the country because the medicine’s manufacturer, ViiV Healthcare, had yet to share how much it would charge the country for the shots.

It was only in late 2023 that ViiV provided pricing details for public sector procurement in certain low-and middle- income countries, including South Africa. That price was around R540 ($30) per dose or R3 240 ($180) per person per year, which the health department said was unaffordable for the country.

The price has since dropped slightly to around R2 880 ($160) per person per year, Mitchell Warren, from the US-based HIV advocacy organisation AVAC, told Spotlight.

In 2024, the health department requested further details from ViiV on its CAB-LA pricing but there is no indication that any progress has been made towards securing a lower price and enabling local procurement of CAB-LA for public sector facilities.

Khadija Jamaloodien, the top official for health products procurement in the National Department of Health, told Spotlight the department could not comment on whether there have been any developments towards local procurement of CAB-LA.

A spokesperson for ViiV told Spotlight: “We have not received any orders to date for CAB-LA for PrEP to supply to South Africa”. PrEP, or pre-exposure prophylaxis, refers to taking an injection to prevent HIV infection.

What about CAB-LA in the private sector?

For those using private healthcare in South Africa, CAB-LA also remains inaccessible. ViiV has not launched CAB-LA in the private sector or disclosed the price at which it will sell CAB-LA through private pharmacies.

ViiV did not respond to Spotlight’s questions regarding its plans and timelines for launching CAB-LA in the country’s private sector.

PEPFAR steps in, but doesn’t deliver

After the health department balked at ViiV’s CAB-LA price for the public sector, the United States President’s Emergency Plan for AIDS Relief (PEPFAR) announced plans to kick start the rollout of CAB-LA in South Africa and some other African countries.

PEPFAR pledged to buy CAB-LA from ViiV for donation to ten African countries during 2024 and 2025. The largest donation of 231 000 CAB-LA doses was designated for South Africa.

While some of the PEPFAR-donated stock began reaching countries before the Trump administration halted foreign aid on 20 January, according to Warren, South Africa never received any of the promised doses.

These donations are no longer expected, given cuts to the agency’s capacity and budget under the Trump administration.

The US State Department did not respond to Spotlight’s questions seeking confirmation that the CAB-LA donations would no longer be delivered, but our health department told Spotlight it doesn’t expect to receive this donation.

Gilead leapfrogs ViiV

Amid the delays and uncertainty surrounding CAB-LA’s pricing and rollout, Gilead, the company that manufactures lenacapavir, has positioned their product to become the first long-acting injectable form of HIV prevention available at any real scale in South Africa.

While lenacapavir is not yet registered in South Africa, Hasina Subedar, the senior technical advisor for HIV prevention in the National Department of Health, told Bhekisisa that it plans to start rolling out lenacapavir in 300 public clinics by April 2026 – less than 10% of the well over 3000 clinics in the country.

SAHPRA authorisation is expected to be granted in the coming months, as lenacapavir has already been recommended for marketing authorisation through the EU medicines for all (EU-M4All) initiative – a process which includes regulators from South Africa. In addition to securing local registration, lenacapavir must also receive a positive recommendation from South Africa’s National Essential Medicines List Committee to enable its rollout.

Gilead has secured a deal with the Global Fund for HIV, TB and Malaria, as well as private donors, that will allow lenacapavir to be rolled out in eight African countries, including in South Africa at a cost to country of R1080 ($60) per person per year.

Under this deal, private donations from the Children’s Investment Fund Foundation (CIFF) will also contribute toward procurement of lenacapavir. CIFF contributions will be above and beyond the $60 contributed by countries per person per year.

While the amount that Gilead will recoup for a year’s supply of lenacapavir under the deal has not been disclosed, it is speculated to be between R1800 ($100) and R2 160 ($120), according to Warren.

He added that Gilead’s deal with the Global Fund will allow countries to begin budgeting and planning for lenacapavir’s rollout using Gilead’s product while they await availability of more affordable generic products in a few years’ time.

The lack of transparency around Gilead’s pricing is uncommon in South Africa, which has strong legal requirements for medicine price transparency. Despite transparency concerns, the National Department of Health has indicated that they will participate in Gilead’s Global Fund arrangement.

By keeping the price secret, two advocacy groups, the Health Justice Initiative and Health Gap, have argued that the deal will undermine efforts in countries not included in the arrangement to negotiate and secure affordable pricing of lenacapavir.

Are HIV prevention injections cost effective for South Africa?

Local researchers have crunched the numbers to establish whether CAB-LA and lenacapavir offer good value for money.

These analyses compared the cost-effectiveness of HIV injections to the widely available prevention pills in public clinics, Lise Jamieson, senior researcher at WITS HE2RO, told Spotlight

The prevention pills provided by the National Department of Health are purchased for R1000 per person per year, said Jamaloodien.

Jamieson said that, according to modelling, prevention injections will avert more HIV infections than prevention pills. Generally speaking, products that provide protection for longer periods are more effective since their efficacy is less dependent on people regularly taking pills or going to the clinic to get an injection. We can thus accept a higher price for lenacapavir (providing six month of protection) than for CAB-LA (only two months of protection) because modelling indicates that this product will avert more HIV infections and delivers more treatment cost savings over time.

Jamieson said according to the latest iteration of their cost-effectiveness modelling, which has not yet been published, CAB-LA needs to be capped around R1800 ($100) per person per year to be cost effective, while lenacapavir needs to be capped around R3600 ($170) per person per year.

Based on this analysis, for South Africa to roll out lenacapavir at $60 per person per year is highly cost-effective, while buying CAB-LA at $160 per person per year is not cost-effective.

Lenacapavir use also requires fewer clinic visits per year than CAB-LA (two versus six) which places less of a strain on health facilities and providers.

Cheaper generic versions of lenacapavir and CAB-LA are expected to become available in 2027.

Lenacapavir generics, Warren said, are expected to enter the market around the same time as generic CAB-LA despite CAB-LA’s initial head start. This is because Gilead was quicker to license generic manufacturers and used a faster licensing approach than ViiV, he added.

Compared to CAB-LA, Warren said it would be faster to show that the generic version of lenacapavir works the same as the original – a necessary step before generic products can be approved. Added to this, he noted that generic companies would likely move faster to bring lenacapavir to market because buyers showed more interest in it.

How will procurement of lenacapavir be funded?

While lenacapavir is cost effective for South Africa at $60 per person per year, purchasing it may nevertheless be challenging given the country’s tight healthcare budget.

HIV prevention pills are procured domestically in South Africa, but Jamieson said the country will need additional funds or donor support to roll out lenacapavir.

The National Department of Health and the Global Fund agreed to allocate R520 million of the country’s Global Fund grant towards buying lenacapavir, Bhekisisa reported in July. This allocation will allow more than 450 000 people in the country to access lenacapavir over the next three years.

Can lenacapavir turn the tide on the epidemic?

In addition to looking at the cost-effectiveness of long acting injectables, Jamieson and her colleagues have modelled how the rollout of injectable HIV prevention options will impact new HIV infections in the country.

Jamieson said if South Africa initiates roughly 1 million people on lenacapavir over the next year and then increase access to reach 4 million people in the next 20 years, HIV incidence could fall below 0.1% by 2038 – with a projected 3.5 million people on lenacapavir by then. At this level, the country would effectively end the HIV epidemic.

Scaling up lenacapavir to this level will require significant political will and additional investment above and beyond what has already been committed by the Global Fund.

Meanwhile, researchers are working on new versions of lenacapavir and CAB-LA that could double the length of protection offered by each.

As Spotlight previously reported, there are promising signs for a lenacapavir formulation that could provide 12 months of protection as opposed to the current six, and a CAB-LA formulation that could provide four months of protection rather than two. HIV prevention tablets that provide a month of protection at a time are also under development. It however remains to be seen whether these new formulations will succeed in the pivotal clinical trials testing their safety and effectiveness.

Republished from Spotlight under a Creative Commons licence.

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Categories : HospitalsTags : 1 Comment

‘We Can’t Save Them Anymore’: Doctors Raise Alarm About Crippling Cuts at Major KZN Hospital

On By ModernMedia
Inkosi Albert Luthuli Central Hospital is KwaZulu-Natal’s only public hospital with a functioning cardiac unit. Photo by Hush Naidoo Jade Photography on Unsplash

By Chris Bateman

Doctors have blown the whistle about a crisis at one of KwaZulu-Natal’s most important public hospitals, saying it is functioning far under capacity due to a series of crippling cuts.

The Inkosi Albert Luthuli Central Hospital in Durban’s Cato Manor is operating at around 40% below surgical capacity, according to senior doctors there. As one of a small number of central hospitals in South Africa, it provides specialist services unavailable elsewhere in KwaZulu-Natal and serves as a critical hub for training healthcare workers.

Several doctors who work at Albert Luthuli, who asked to remain anonymous for fear of reprisals, told Spotlight that frozen posts, severely understaffed ICUs, shortages of surgical consumables, and delays in diagnostic tests have combined to drive an austerity-fuelled collapse they say is costing lives.

One doctor said theatre slates – daily surgery schedules – have been cut by as much as 60% compared to pre-pandemic levels. Some described the situation as worse than during COVID-19, when all elective surgeries were cancelled.

“Patients have to wait or be sent home when they can’t get on a theatre list. Then they’re either lost to follow-up or they present ‘in extremis’ later,” said one senior doctor. “Paediatric cases are among the worst. They should be referred on day one, but because of ICU nursing shortages they only get admitted on day four or five – if at all. Often, they’re too ill for our care to be effective.”

Spotlight put these allegations to the KwaZulu-Natal Department of Health, but the department had not responded by deadline despite several follow-ups.

Collapsing specialist services

Albert Luthuli is KwaZulu-Natal’s only public hospital with a functioning cardiac unit, according to one of the doctors who spoke to Spotlight. The doctor said the province has just one adult cardiologist in the public sector who sees over 60 patients per day and that cardiac surgeries have dropped from 600 per year to under 300 projected for 2025. By contrast, there are over 30 adult cardiologists working in the private sector in the province.

Anaesthesiology is among the hardest hit areas. According to Spotlight’s sources, eight anaesthetic consultants resigned in the past year, citing burnout and workload. Where nine or ten theatre slates once ran daily, there are now only four or five. Eleven anaesthetists remain to cover 19 theatres.

“I never thought I’d see the day when I wouldn’t want to come in. We are four ICU consultants covering nine beds. ICU needs one nurse per bed, but we’re usually staffed with six or seven nurses in total. Across six ICUs, we’ve got 25 nurses. We pull in ward staff or rely on overtime. You can’t have one nurse running between beds – it spreads infection, mistakes happen. It’s impossible,” one ICU doctor told Spotlight.

Doctors estimate a 45% shortage of qualified ICU nurses. “It’s like airplanes circling, running out of fuel, and crashing before they can land,” one senior doctor said. “Patients deteriorate while waiting for beds or for a theatre list to open.”

Specialist theatre nursing posts have also been cut, compounding the strain.

Registrars squeezed, training undermined

The hospital is meant to offer advanced procedures, experimental treatments, innovative research, and specialist training. Instead, registrars – these are doctors in specialist training – say they are losing out on irreplaceable experience.

Junior registrars are allegedly blocked from logging procedures they need to qualify, because seniors are prioritised to assist with the shrinking pool of operations.

Spotlight has seen a grievance letter from the Anaesthetics Department’s Registrar Representative, addressed to the hospital CEO, medical manager, the SA Society of Anaesthesiologists, and training stakeholders. It warns that the consultant exodus has left registrars running high-risk cases with inadequate supervision, “directly compromising both patient safety and registrar training.”

One senior doctor said theatre usage had more than halved in recent months compared to historical averages. With no new registrar intake and no appointments of departed registrars to consultant posts, it is projected only 10 or 12 permanent consultants will remain for the hospital’s 846 beds – there should be at least 21 consultants. (A registrar becomes a consultant, or qualified specialist, once their training is complete.)

“This is no longer a looming concern, but an active crisis,” the letter warned, threatening patient safety, staff wellbeing, and the integrity of training in KwaZulu-Natal.

“What they broke in six months will take years to fix,” said one registrar.

But some are more positive. Professor Dean Gopalan, Head of Anaesthesiology, Pain Medicine & Critical Care at UKZN’s School of Medicine, said austerity cuts had dented efforts to achieve excellence, but “we remain above required training norms”. He said he was awaiting feedback from the Health Professions Council (HPCSA), which inspected the hospital in July and raised concerns about specialist and nurse shortages. Spotlight followed up with the HPCSA, but had not received a response by the time of publication.

Not all departments are as fortunate. One doctor said it would be “almost impossible” to meet training accreditation standards for cardiology given the patient workload.

Human cost

Doctors say the crisis is most visible in paediatric congenital heart disease cases.

“These children could live normal lives if operated on early. Instead, they wait until they are drastically sick before making the theatre slate – often six months later,” said one doctor. “People forget surgery is also a primary healthcare intervention. Breadwinners sit at home unable to work, while their families suffer.”

In orthopaedics, doctors say the waiting list exceeds 1 300 patients, with the first elective surgery dates only available in March 2028. Before COVID-19, they say the waiting period was seven months.

“Many patients are unable to work due to their conditions and would be able to get back to work if they had their operations,” said one source. “We try prioritising them, but then you put them ahead of others also in severe pain. Complications are already coming in from other hospitals due to unavailable implants and delayed treatments.”

Procurement freeze

Several doctors trace the crisis to a “G77 notice” issued by the KZN Department of Health on 14 November 2024, freezing new purchase orders until April 2025 to “manage accruals” and reduce overspending. Exceptions required approval from head office.

While a less prescriptive circular has since replaced it, procurement remains “extremely difficult”, sources said.

Doctors said the freeze caused months-long delays in acquiring consumables, drugs, and equipment. “We’re almost at the point where we’re only doing emergencies,” said one doctor. “We prioritise cancer patients for chemo or radiation instead of urgently needed surgery. But in cardiac surgery, there’s definite mortality. You can’t avoid it when you can’t do bypasses or valve replacements. Waiting lists are years long.”

One anaesthetist recalled a patient being “closed” mid-operation because a critical consumable was unavailable.

A national problem?

The situation at Albert Luthuli hospital partly reflects a wider national crisis in specialist care. A 2019 government strategy paper noted only 16.5 specialists per 100 000 people overall, with just seven per 100 000 in the public sector, compared to 69 per 100 000 in private.

Professor Eric Buch, CEO of the Colleges of Medicine of SA, said austerity has worsened matters by reducing registrar posts and constricting the pipeline. “Specialist posts are being frozen, impeding access to specialist care and reducing the number of specialists available to train registrars. Even before austerity we had far too few specialists. Some registrars waited up to two years for a post.”

The Albert Luthuli hospital crisis is “not unique”, said Dr Reno Morar, COO of Nelson Mandela University’s Faculty of Health Sciences.

“Equity of access to specialised services simply does not exist,” he said. “Despite the mess, there are pockets of excellence, but there’s no strategic national vision for highly specialised services.”

Health Ombud Professor Taole Mokoena told Spotlight his office had not specifically investigated Albert Luthuli, but said that, “sadly, there are reports not dissimilar from many hospitals in the country,” citing Helen Joseph Hospital in Johannesburg and Robert Mangaliso Sobukwe Hospital in Kimberley.

Doctors at Albert Luthuli hospital have indicated to Spotlight they will lodge a formal complaint with the health Ombud.

Posts advertised

While the KZN Department of Health did not respond to Spotlight’s questions, there are signs of movement. Two days after we requested comment, a circular went out advertising dozens of specialist posts across provincial referral hospitals, including 12 anaesthetics posts, five of them at Albert Luthuli, plus 100 staff nurse and 50 registered nurse posts.

We also understand that an internal briefing of department heads was called for 27 August, 36 hours after Spotlight’s first request for comment.

Doctors, however, remain sceptical.

“Nothing will change for six months as we go through the interview, verification, and induction processes. Why did they take so long to listen? The damage is done. Relief is 18 to 24 months too late,” said one doctor.

Another senior doctor said that with each resignation over the past year, he lined up replacements and pleaded in vain for permission to advertise. “Since posts reopened this week, I know of just one applicant. Do they expect specialists to suddenly appear out of the woodwork?”

The job advertisements are for “far less than what has been lost and needed. And it’s far more than just numbers – it’s skills and experience”, noted another doctor. “It will take years to get back to where we were.”

Despair among staff

Several doctors expressed despair at what they see as a lack of urgency from government.

“It makes me wonder how resources are managed. Local cuts feel disproportionate compared to national ones. It’s disheartening. Some of us are here to make a difference, but we’re starting to lose hope,” one said.

Another added: “If you know there’s light at the end of the tunnel, you can keep going. But when it feels endless, it’s damn hard. We try to hide our disenchantment, but it’s becoming impossible.”

Republished from Spotlight under a Creative Commons licence.

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Categories : Cancer Ethics and LawTags :

What Next for Cancer Patients as Court Again Rules Against Gauteng Health Department?

On By ModernMedia
Photo by Bill Oxford on Unsplash

By Ufrieda Ho

In the latest chapter of a long-running legal battle over the Gauteng Department of Health’s obligation to provide people in the province with radiation oncology services, the department has suffered another loss in the courts. Spotlight assesses the legal situation and asks what it means for people still waiting for the life-saving treatment.

With another court loss suffered this August, the Gauteng Department of Health has once again been ordered to urgently provide treatment for cancer patients who have been left in the lurch.

This ruling, handed down on August 5 by Judge Evette Dippenaar, follows urgent legal action brought by the Cancer Alliance. It was in response to the Gauteng health department’s appeal against a ruling handed down on March 27 by acting Judge Stephen van Nieuwenhuizen. That order compelled the department to clear its years-long backlogs in getting cancer treatment to patients.

In its March ruling, the South Gauteng High Court in Johannesburg found the department’s failure to deliver this critical treatment to be unconstitutional and unlawful. The decision follows the department’s failure to spend a R784 million allocation granted by the provincial Treasury in 2023 to reduce the treatment backlog by outsourcing services to the private sector over a three-year period. Due to severe delays, the department was forced to return the first R250 million tranche.

Van Nieuwenhuizen strongly criticised the department, stating: “The provincial health respondents have done nothing meaningful since the money was allocated in March 2023 to actually provide radiation oncology treatment to the cancer patients. Meanwhile, the health and general well-being of the patients has significantly deteriorated. There is clear, ongoing, and irreparable harm being suffered by those still waiting for treatment.”

He also condemned the department for its lack of accountability and poor management of public resources, finding that it had failed to uphold ethical standards, act transparently, or respond to patients’ needs fairly and effectively.

The court instructed the department to:

  • Take immediate action, including diversion to private facilities, to provide radiation oncology services to all patients on the backlog list,
  • Update the backlog list within 45 days,
  • Submit a detailed progress report on efforts to deliver treatment, and
  • Present a long-term plan for ongoing cancer treatment services within three months.

But Gauteng health MEC Nomantu Nkomo-Ralehoko and the health department challenged the judgment in May, just as their 45 days to act ran out. They chose instead to take the entire matter on appeal to the Supreme Court of Appeal (SCA).

In response, the Cancer Alliance, represented by SECTION27 (*see disclosure), went back to court for an interim order to make the March 27 ruling immediately enforceable, and not suspended until a ruling is made by the SCA. It is in response to this application that Judge Dippenaar ruled on August 5 that the March ruling is indeed immediately enforceable.

Two courts have now sent a clear message to the Gauteng health department, says attorney Khanyisa Mapipa, who heads health rights at SECTION27. She adds: “The Gauteng Department of Health’s action should be in the interest of the person who is seeking treatment. It should not be to deny, deny, deny and then to fight in the courts and not take any accountability.”

The waiting list

The estimated number of people on a waiting list for cancer treatment in 2022 was around 3 000 people. New data on this has not been made publicly available.

There are some signs of progress, although details are hard to pin down. In a statement released on August 24, which reiterates a July 20 statement, the Gauteng health department said it had introduced a strategic partnership with private service providers. “As the beginning of August 2025, 563 patients were receiving radiation oncology care through private partnerships, while 1 076 patients had completed treatment by end of July 2025,” it stated.

Both statements also noted that work was underway to complete new radiotherapy centres at Chris Hani Baragwanath and Dr George Mukhari Academic Hospitals.

But Mapipa says they still don’t have full details that comply with the court order. “What we’re asking for essentially is what the department should be doing anyway and that is for them to go through their patient files to establish who is still on the backlog list; who has passed away, who has received treatment, when patients were last assessed and what treatment they qualify for; and if it was a public facility or were they diverted to a private facility,” she says.

“As the judge pointed out in March, the department has to do this as a constitutional obligation, whether they fight this to the Constitutional Court or not, their obligation is to provide treatment for people who meet the criteria. Those on the backlog list meets the criteria,” she says.

Part of the March order also compelled the department to file progress reports with the court within three months on the measures taken to provide treatment and its long-term plans to resolve the ongoing cancer treatment crisis in Gauteng. Spotlight’s understanding is that these progress reports have not been submitted.

This is an important measure, Mapipa says, given the department’s poor track record. “The court rulings in both judgments found that because they have failed to be transparent throughout this process, the department is compelled to provide these reports to the courts,” she adds.

It is as yet unclear how the Gauteng health department plans to proceed. The department, in its three-paragraph statement following the August judgment, stated that it would review “the contents and implications” to determine and communicate its next steps. Their deadline to appeal the August 5 ruling was 26 August 2025. The department did not respond to questions from Spotlight.

Calls for accountability

Jack Bloom, Democratic Alliance shadow health MEC in Gauteng, says that without a proper audit and update of the backlog list of patients needing care, the “cancer treatment scandal has probably cost more lives than the 144 mental patients who died in the Life Esidimeni tragedy when they were sent to illegal NGOs”.

Bloom is calling for heads to roll, with Nkomo-Ralehoko and head of department Arnold Lesiba Malotana in his crosshairs.

“The DA condemns the department’s legal stalling tactics that harms patients who urgently require lifesaving treatment…Premier [Panyaza] Lesufi should not allow this cancer disaster to continue,” he says.

Salomé Meyer, spokesperson for Cancer Alliance, says that the legal proceedings are a distraction of the realities on the hospital floor. Charlotte Maxeke Johannesburg Academic Hospital for instance, she says, remains in “crisis”. She maintains there is a scarcity of sufficient and operational radiation oncology machinery, as well as extreme shortages in radiation oncology staff to operate the machines.

Meyer says the situation at Charlotte Maxeke Hospital dates back to 2017 when CEO Gladys Bagoshi was made aware of mounting challenges from a shortage of equipment and staffing.

“In 2021, Bagoshi turned down an equipment allocation, which Charlotte Maxeke Hospital desperately needed, so this allocation went to George Mukhari Hospital and Chris Hani Baragwanath Hospital instead. But the cobalt bunkers required to house the machines at these hospitals had not been built and are only expected to be completed in 2026 – so the machines remain in storage. In 2022, an order was finally placed for additional linacs [used for high energy beam radiation treatments] for the existing cobalt bunkers at Charlotte Maxeke Hospital, but that tender is still not finalised,” says Meyer.

She adds: “This is a failure of planning, governance, and accountability and we have to ask who is being held accountable when the same CEO has remained in place all these years.”

Neither Bagoshi nor the health department responded to questions on these assertions.

Disclosure: SECTION27 was involved in the court proceedings described in this article. Spotlight is published by SECTION27, but is editorially independent – an independence that the editors guard jealously. The Spotlight editors gave special attention to maintaining this editorial firewall in the production of this story.

Republished from Spotlight under a Creative Commons licence.

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Categories : Healthcare Politics and Regulations HIVTags :

Inside SA’s Multi-million Rand Plan to Fill US Funding Void

On By ModernMedia
Photo by Miguel Á. Padriñán

By Jesse Copelyn

In response to US funding cuts for South African health services and research projects, National Treasury has provided the National Department of Health with hundreds of millions of rands in emergency funds. Spotlight and GroundUp look at how precisely the government intends to spend this money.

Health Minister Dr Aaron Motsoaledi recently announced that National Treasury had released roughly R753 million to help plug the gap left by US funding cuts to South Africa’s health system. Another R268 million is also being released in the following two years for researchers that lost their US grants.

But this may only constitute the first round of emergency funds from government, according to sources we spoke to. The health department is planning on submitting a bid for an additional allocation later on, which will be considered by Treasury. But this will likely only be approved if the first tranche of funding is properly used.

So how is the money supposed to be used? To find out, we spoke with officials from the National Treasury, the National Department of Health and the South African Medical Research Council (SAMRC).

Money for provinces is for saving jobs at government clinics

The current tranche of money comes from Treasury’s contingency reserve, which exists partially to deal with unforeseen funding shortfalls. It was released in terms of Section 16 of the Public Finance Management Act.

Of the R753 million that’s been announced for this year, Motsoaledi stated that R590 million would be going to provincial health departments via the District Health Programme Grant – a conditional grant for funding the country’s public health efforts, particularly HIV, TB, and other communicable diseases. Such conditional grants typically give the health department more say over how provincial departments spend money than is the case with most other health funding in provinces.

To explain how government officials arrived at this figure, it’s worth recapping what services the US previously supported within provinces.

Prior to Donald Trump becoming US president on 20 January, the US Agency for International Development (USAID) had financed health programmes in specific districts with high rates of HIV. These districts were scattered across all South Africa’s provinces, save for the Northern Cape.

The funds were typically channelled by USAID to non-governmental organisations (NGOs), which used the money to assist the districts in two ways.

The first is that NGOs would hire and deploy health workers at government clinics. The second is that the NGOs would run independent mobile clinics and drop-in centres, which assisted so-called key populations, such as men who have sex with men, sex workers, transgender people, and people who inject drugs.

Following the US funding cuts, thousands of NGO-funded health workers lost their jobs at government clinics, while many of the health centres catering to key populations were forced to close.

In response, the health department began negotiations with Treasury to get emergency funding to restore some of these services. As part of its application, the health department submitted proposals for each province, which specified how much money was needed and how it would be used. (Though this only took place after significant delay and confusion).

Since Treasury couldn’t afford to plug the entire gap left by the US funding cuts, the provincial-level proposals only requested money for some of the services that had been terminated. For instance, funding was not requested for the key populations health centres. Instead, the priority was to secure the jobs that had been lost at government health facilities.

As such, the total amount that was requested from Treasury for each province was largely calculated by taking the total number of health workers that NGOs had hired at clinics and working out how much it would cost to rehire them for 12 months.

Rather than paying the NGOs a grant to deploy these workers as was done by USAID, the health department proposed hiring them directly. This meant that they calculated their wages according to standard government pay scales, which is less than what these workers would have earned from the NGOs.

The total came to just under R1.2 billion for all the provinces combined.

Treasury awarded roughly half of this on the basis that the money would be used to finance these wages for six months, rather than 12. This amounts to the R590 million for provinces that was announced by Motsoaledi.

If all goes smoothly and this money is used effectively to hire these staff over the next six months, then a new tranche of Section 16 funding could be released in order to continue hiring them. Funds might also be released to fund the key populations health sites.

A concern, however, is that the money may just be used by provinces to augment their ordinary budgets. If the funds aren’t actually used to respond to the US cuts, then it is much less likely that more emergency funding will be released.

At this stage, it is too early to tell how provinces will use the money, particularly given that it appears that at least some of them haven’t gotten it yet.

Spotlight and GroundUp sent questions to several provincial health departments. Only the Western Cape responded. The province’s MEC for Health and Wellness, Mireille Wenger, said that the funds have not yet been received by her department, but that once they were, they would be directed to several key priority areas, including digitisation of health records, and the strengthening of the primary healthcare system.

It’s thus not clear whether the province will be using any of the funds to employ health staff axed by US-funded NGOs. In response to a question about this, Wenger stated that “further clarity is still required from the National Department of Health and National Treasury regarding the precise provincial allocations and conditions tied to the additional funding”.

What about research?

Of the R753 million that’s been released for this year, R132 million has been allocated to mitigate the funding cuts for research by US federal institutions, primarily the National Institutes for Health (NIH). Unlike USAID, the NIH is not an aid body. It provides grants to researchers who are testing new treatments and medical interventions that ultimately benefit everyone. These grants can be awarded to researchers in the US or abroad as part of a highly competitive application process.

Researchers in South Africa are awarded a few billion rands worth of grants from the NIH each year, largely due to their expertise in HIV and TB. But over the last few months, much of this funding has been terminated or left in limbo. (See a detailed explanation of the situation here).

The R132 million issued by Treasury is supposed to assist some of these researchers. It will be followed by another R268 million over the following two years. The Gates Foundation and Wellcome Trust are chipping in an additional R100 million each – though in their case, the funds are being provided upfront.

All of this money – R600 million in total – is being channelled to the SAMRC, which will release it to researchers via a competitive grant allocation system.

According to SAMRC spokesperson Tendani Tsedu, they have already received the R132 million from Treasury, though they are still “finalizing the processes with the Gates Foundation and Wellcome Trust for receipt of [their donations]”.

The SAMRC is also in negotiation with a French research body about securing more funds, though these talks are ongoing.

In the meantime, the SAMRC has sent out a request for grant applications from researchers who have lost their US money. The memo states: “Applicants may apply for funding support for up to 12 months to continue, wind down or complete critical research activities and sustain the projects until U.S. funding is resumed or alternative funds are sourced.”

“The plan,” Tsedu said, “is to award these grants as soon as possible this year.”

Professor Linda-Gail Bekker, CEO of the Desmond Tutu Health Foundation, told us that the hope is that the grants could fill some of the gaps. “This is a bridge and it is certainly going to save some people’s jobs, and some research,” she said, but “it isn’t going to completely fill the gap”.

Indeed, the SAMRC has made clear that its grants aren’t intended to replace the US funding awards entirely. This is unsurprising given that the money that’s being made available is a tiny fraction of the total grant funding awarded by the NIH.

It’s unlikely that research projects will continue to operate as before, and will instead be pared down, said Bekker.

“It’s going to be about getting the absolute minimum done so you either save the outcome, or get an outcome rather than no outcome,” she said.

In other cases, the funds may simply “allow you to more ethically close [the research project] down,” Bekker added.

For some, this funding may also have come too late. Many researchers have already had to lay off staff. Additionally, patients who had been on experimental treatments may have already been transitioned back into routine care. It’s unclear how such projects could be resumed months later.

In response, Tsedu stated: “For projects that have already closed as a result of the funding cuts, the principal investigator will need to motivate whether the study can be appropriately resurrected if new funds are secured.”

The SAMRC has established a steering committee which will adjudicate bids. They will be considering a range of criteria, Tsedu said, including how beneficial the research might be for the South African health system, and how heavily the project was impacted by the US funding cuts. They will also consider how an SAMRC grant could “be leveraged for future sustainability of the project, personnel or unit”, added Tsedu.

An endless back and forth

The job of the SAMRC steering committee will likely be made a lot more complicated by the erratic policy changes within the NIH. On 25 March, the body sent a memo to staff – leaked to Nature and Bhekisisa – instructing them to hold all funding awards to researchers in South Africa. After this, numerous researchers in the country said they couldn’t renew their grants.

However, last month, Science reported that a new memo had been sent to NIH staff which said that while South African researchers still couldn’t get new grants, active awards could be resumed.

Since then, some funds appear to be trickling back into the country, but certainly not all. For instance, Spotlight and GroundUp spoke to one researcher who had two active NIH awards before the cuts. He stated that one of these was resumed last month, while the other is still paused.

Bekker also told us that she had heard of one or two research grants being resumed in the last week, though she said the bulk of active awards to South Africa are still pending.

“Where people are the prime recipients [of an NIH grant] without a sub awardee, there seems to be a queue and backlog but some [of those awards] are coming through,” said Bekker. “But how long this is going to take and when it might come through, we’re waiting to hear.” She said a strategy might be to apply for the SAMRC bridging funding and “if by some miracle the [NIH funding is resumed]” then researchers could then presumably retract their SAMRC application.

In the meantime, health researchers will have to continue spending their time working out how to respond to the abrupt and increasingly confusing changes to funding guidelines that have dogged them since Trump assumed office.

“It’s such a dreadful waste of energy,” said Bekker. “If we were just getting on with the research, it would be so much better.”

This article was jointly produced by Spotlight and GroundUp.

Republished from Spotlight under a Creative Commons licence.

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Categories : Ethics and Law Healthcare Politics and RegulationsTags :

#InsideTheBox with Dr Andy Gray | Should Pharmaceutical Advertising in SA Be Better Regulated, and Why?

On By ModernMedia
#InsideTheBox is a column by Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. (Photo: Supplied)

By Andy Gray

For over 20 years, the law has required that the Minister of Health issues regulations to govern the advertising of medicines in South Africa, but as yet no such regulations are in place. In his latest #InsideTheBox column, Dr Andy Gray considers what this means for the marketing of medicines in the country.

Anyone who has travelled to the United States will have been struck by the extent to which medicines, both those requiring a prescription and those that can be bought by consumers without a prescription, are advertised on television.

The situation in South Africa is quite different. While there are many advertisements for medicines shown on local television stations, only some are specific about the proprietary (brand) name of the medicine and its indications. Other advertisements focus instead on the indication (the reason for using the medicine), but do not identify it by name. Instead, viewers are urged to approach their pharmacies or medical practitioners. At a different time, an advertisement may be flighted which identifies a medicine, its strength, pack size and perhaps price, but provides no information about what the indication for the medicine is.

To what extent does this represent meaningful and justified regulatory control over pharmaceutical marketing?

Only two countries with effective medicines regulatory systems allow prescription-only medicines to be advertised directly to the consumer, these being the United States and New Zealand. Other countries, including South Africa, restrict the advertising of prescription-only medicines to the health professionals who can prescribe or dispense them. One of the key justifications for this restriction on the ability of the pharmaceutical industry to market their products is that direct-to-consumer advertising may result in more inappropriate prescribing, when prescribers are under pressure from patients demanding medicines they have seen advertised. Short television advertisements are unlikely to be able to convey a balanced account of the potential benefits and harms of medicines, especially those that are new to the market.

South African law contains an interesting variant to regulation in this area. General Regulation 42 issued in terms of the Medicines and Related Substances Act, 1965, allows medicines containing substances in Schedules 0 and 1 to be advertised to the public, but requires that those containing substances in Schedules 2 to 6 to be advertised “only for the information of pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers” or “in a publication which is normally or only made available” to such persons. While Schedule 0 medicines can be bought in any retail outlet, Schedule 1 and 2 medicines can only be obtained from a pharmacy, but not self-selected from a shelf. The justification for that particular cut-off is difficult to trace in any policy document. An amendment to the regulation was published for comment in February 2023, but the final regulation has yet to be issued by the Minister of Health.

‘Failure to follow through’

The fundamental problem, however, lies in a failure to follow through on the legislation previously passed by Parliament. Section 18C of the current version of the Medicines and Related Substances Act, 1965, contains a prescriptive instruction to the Minister. “The Minister shall, after consultation with the relevant industries and other stakeholders, make regulations relating to the marketing of medicines, medical devices or IVDs and such regulations shall also provide for Codes of Practice for relevant industries,” it states. From 2003 to 2017, the section read: “The Minister shall, after consultation with the pharmaceutical industry and other stakeholders, make regulations relating to the marketing of medicines, and such regulations shall also provide for an enforceable Code of Practice.” The expansion of the remit, to include medical devices and in vitro diagnostics (IVDs) was added by Parliament in 2008, but only took effect in 2017.

Photo by Derek Finch

The wording is peremptory – the Minister “shall” – which leaves no room for delay. While the word “enforceable” has been removed, the very intent of a regulation is that it should be enforced. That no regulations have been forthcoming in more than 20 years is an extraordinary failure of governance.

That failure is compounded by another act of omission. Section 18A of the Act states: “No person shall supply any medicine, medical device or IVD according to a bonus system, rebate system or any other incentive scheme.” The law also enables the Minister to “prescribe acceptable and prohibited acts” in this regard, in consultation with the Pricing Committee. No final regulations have been issued since 2017. The Pricing Committee is established to advise the Minister on matters relating to the pricing of medicines, such as the annual maximum increase and the dispensing fees charged by pharmacists and licensed dispensing practitioners.

It is already an offence, in terms of section 29 of the Act, for any person to make “any false or misleading statement in connection with any medicine, Scheduled substance, medical device or IVD”. Regulation 42 also states: “No advertisement for a medicine may contain a statement which deviates from, with or goes beyond the evidence submitted in the application for registration of such medicine with regard to its safety, quality or efficacy where such evidence has been accepted by the Authority in respect of such medicine and incorporated into the approved information of such medicine”.

While these two provisions may prevent false or misleading advertising, they are limited in their scope. In particular, since no complementary medicines are yet registered by the South African Health Products Regulatory Authority (SAHPRA), none have an approved professional information (previously known as a package insert) or a patient information leaflet.

Industry self-regulation

The pharmaceutical and medical devices industries have not been idle during this period of government inaction. A non-profit, self-regulatory body, the Marketing Code Authority (MCA), has developed a Code of Marketing Practice, drawing on international guidelines. This code provides for sanctions when rules are broken, following adjudication of a complaint. Fines of up to a maximum of R500 000 can be levied for severe or serious offences, which would, for example, pose “safety implications for patients”.

However, as a self-regulatory body, the MCA cannot require membership by any licensed manufacturer. It means that those manufacturers which are not members of the MCA are not bound by the Code and cannot be sanctioned. The MCA therefore advocates that compliance with a Code should be a condition to get a license to operate as a manufacturer. The MCA has also responded to draft regulations on perverse incentives.

At a time when deliberate disinformation is being disseminated from many quarters, including from government authorities previously considered to be reliable, a weakened regulatory system cannot simply be allowed to stagger along, in defiance of the express instructions of the legislature. Public safety demands an effective regulatory mechanism to proactively examine pharmaceutical marketing, across all media, the ability to take meaningful action where transgressions are identified, and an even playing field for all actors.

*Dr Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is part of a new series of #InsideTheBox columns he is writing for Spotlight.

Disclosure: Gray is a member of South Africa’s National Essential Medicines List Committee and co-chairs its Expert Review Committee.

Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.

Republished from Spotlight under a Creative Commons license.

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Categories : COVID Expert OpinionTags :

Don’t Panic About New SARS-CoV-2 Variant, Experts Say

On By ModernMedia

By Biénne Huisman

COVID-19 has largely dropped out of the headlines, but the virus that causes it is still circulating. We ask what we should know about a new variant of SARS-CoV-2, the state of the COVID-19 pandemic in 2025, and the lack of access to updated vaccines in South Africa.

In the leafy Johannesburg suburb of Sandringham, the National Institute for Communicable Diseases (NICD) bears a deceptive facade. Do not be fooled by its sleepy campus, clustered face brick buildings and shade-cloth parking, this government facility is home to state-of-the-art biosafety laboratories and some of South Africa’s top virologists, microbiologists and epidemiologists. Here, 71 scientists are tasked daily with laboratory-based disease surveillance to protect the country from pathogen outbreak events.

On 5 March 2020, then health minister Dr Zweli Mkhize announced South Africa’s first COVID‑19 infection at an NICD press briefing. At the time, the NICD was an obscure acronym for many – but that quickly changed as the institution became central to the country’s pandemic response.

While the COVID-19 pandemic may have waned, the NICD hasn’t stopped monitoring.

That is because there remains a global public health risk associated with COVID-19. The World Health Organization (WHO) states: “There has been evidence of decreasing impact on human health throughout 2023 and 2024 compared to 2020-2023, driven mainly by: 1) high levels of population immunity, achieved through infection, vaccination, or both; 2) similar virulence of currently circulating JN.1 sublineages of the SARS-CoV-2 virus as compared with previously circulating Omicron sublineages; and 3) the availability of diagnostic tests and improved clinical case management. SARS-CoV-2 circulation nevertheless continues at considerable levels in many areas, as indicated in regional trends, without any established seasonality and with unpredictable evolutionary patterns.”

Thus, while SARS-CoV-2 is still circulating, it is clearly not making remotely as many people ill or claiming nearly as many lives as it did four years ago. Asked about this, Foster Mohale, spokesperson for the National Department of Health, says “there are no reports of people getting severely sick and dying due to COVID-19 in South Africa at the current moment”.

‘Variant under monitoring’

As SARS-CoV-2 circulates, it continues to mutate. The WHO recently designated variant NB.1.8.1 as a new variant under monitoring. There is however no reason for alarm. Professor Anne von Gottberg, laboratory head at the NICD’s Centre for Respiratory Diseases and Meningitis, tells Spotlight that NB.1.8.1 is not a cause for panic, particularly not in South Africa.

Von Gottberg says no cases of the new variant has been detected in South Africa. She refers to her unit’s latest surveillance of respiratory pathogens report for the week of 2 to 8 June 2025. It states that out of 189 samples tested, 41 (21.7%) cases were influenza, another 41 (21.7%) cases were respiratory syncytial virus (RSV), and three (1.6%) cases were earlier strains of SARS-CoV-2.

These figures suggest much greater circulation of influenza and RSV in South Africa than SARS-CoV-2. Over the past six months, 3 258 samples were tested, revealing 349 (10.7%) cases of influenza, 530 (16.3%) cases of RSV, and 106 (3.3%) cases of SARS-CoV-2. Since most people who become sick because of these viruses are not tested, these figures do not paint the whole picture of what is happening in the country.

As of 23 May 2025, the WHO considered the public health risk of NB.1.8.1 to be “low at the global level”, with 518 iterations of the variant submitted from 22 countries, mainly around Asia and the Pacific islands.

The WHO report states: “NB.1.8.1 exhibits only marginal additional immune evasion over LP.8.1 [first detected in July 2024]. While there are reported increases in cases and hospitalisations in some of the WPR [Western Pacific Region] countries, which has the highest proportion of NB.1.8.1, there are no reports to suggest that the associated disease severity is higher as compared to other circulating variants. The available evidence on NB.1.8.1 does not suggest additional public health risks relative to the other currently circulating Omicron descendent lineages.”

Combating misinformation

Von Gottberg says that the NICD plays a critical public health communication role in combating misinformation and warns against alarmist and inaccurate online depictions of NB.1.8.1, the Omicron-descendent lineage dubbed “Nimbus” by some commentators.

“There’s fake news about NB.1.8.1 going around on social media,” she says. “For example, supposed symptoms. I have been trying to look for articles and have not seen anything from [reliable sources],” she says. “In fact, there is no information about whether there are any differences in symptoms, because there are so few cases and it is not causing more severe disease.”

Von Gottberg implores members of the public to check information sources. “We try hard – and the Department of Health does the same – to put media releases out so that accurate information is shared. What we ask is that all our clients, the public, verify information before they start retweeting or resending.”

COVID-19 vaccines in South Africa

The WHO recommends that countries ensure continued equitable access to and uptake of COVID-19 vaccines. They also note that the currently approved COVID-19 vaccines are expected to remain effective against the new variant. But contrary to WHO advice, newer COVID-19 vaccines are not available in South Africa and continued access to older vaccination seems to have ceased. When Spotlight called two branches of two different major pharmacy retailers in Cape Town asking for available COVID-19 vaccines, the answer at both was that they have none.

Several recently approved COVID-19 vaccines are being used in other countries but are not available in South Africa. These include Moderna’s updated mRNA boosters, approved in the United States and parts of Europe, Novavax’s Nuvaxovid vaccine, approved in the United States, and Arcturus Therapeutics’s self-amplifying mRNA vaccine Zapomeran, approved in Europe. Self-amplifying mRNA vaccines has the additional capacity to induce longer lasting immune responses by replicating the spike-proteins of SARS-CoV-2.

None of these vaccines are under review for registration in South Africa, according to the South African Health Products Regulatory Authority (SAHPRA). Vaccines may not be made available in the country without the green light from SAHPRA. “It may be advisable to contact the owners of the vaccines to obtain clarity on whether they intend to submit for registration,” says SAHPRA spokesperson Yuven Gounden.

Spotlight on Friday sent questions to Moderna, Novavax, and Arcturus, asking whether they plan to submit their vaccines for registration with SAHPRA, and if not, why not. None of the companies responded by the time of publication.

Von Gottberg explains that vaccines can only become available in South Africa if their manufacturers submit them to SAHPRA for approval. “So, if a vaccine provider, a vaccine manufacturer, does not want to sell in our country because they do not see it as a lucrative market, they may not even put it forward for regulation so that it can be made available.”

Professor of Vaccinology at the University of the Witwatersrand, Shabir Madhi, says the major concern with the lack of licensed SARS-CoV-2 vaccines in South Africa is that “high-risk individuals remain susceptible to severe COVID-19, as there is waning of immunity”.

“High-risk individuals should receive a booster dose every 6-12 months, preferably with the vaccine that is updated against current or most recent variants,” he says.

Von Gottberg has similar concerns. “My hope as a public health professional is that these vaccine manufacturers take us seriously as a market in South Africa and in Africa, very importantly, and put these vaccines and products through our regulatory authorities so that they can be made available both in the public and in the private sector for all individuals who are at risk and should be receiving these vaccines,” she says.

Gounden notes that should a public health need arise, “SAHPRA is ready to respond in terms of emergency use approval.”

Concerns over vaccine expert dismissals in the United States

Earlier this month in the United States, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. fired all 17 members of the Advisory Committee on Immunisation Practices (ACIP) – an expert body responsible for recommending vaccines for 60 years. He then appointed eight new members, some known for vaccine skepticism.

Commenting on this, Von Gottberg says: “I am hoping there will be those who will think about what he [Kennedy] is doing and question it. It is an unusual situation in the United States, you cannot call it business as usual.”

In an article published in the Journal of the American Medical Association, former ACIP members voice grave concerns over the dismissals. “Vaccines are one of the greatest global public health achievements. Vaccine recommendations have been critical to the global eradication of smallpox and the elimination of polio, measles, rubella, and congenital rubella syndrome in the US. They have also dramatically decreased cases of hepatitis, meningitis, mumps, pertussis (whooping cough), pneumonia, tetanus, and varicella (chickenpox), and prevented cancers caused by hepatitis B virus and human papilloma viruses. Recent scientific advancements enabled the accelerated development, production, and evaluation of COVID-19 vaccines…,” they write.

The article also questioned the announcement by Kennedy Jr. on X that he had signed a directive to withdraw the recommendation for COVID-19 vaccination in healthy children and healthy pregnant people.

“[R]ecent changes to COVID-19 vaccine policy, made directly by the HHS secretary and released on social media, appear to have bypassed the standard, transparent and evidence-based review process. Such actions reflect a troubling dis-regard for the scientific integrity that has historically guided US immunisation strategy,” the authors warn.

Von Gottberg adds: “We hope that this anti-vax, the denialism of vaccines and the good they do, won’t come to South Africa.”

In addition, she cautions public healthcare professionals to take heed of this discourse. “We must take seriously that people have questions, and that they want to see us doing things correctly, transparently, always telling people of our conflicts of interest, being very upfront when things are controversial, when it’s difficult to make decisions,” she says. “So I think what this teaches us is not to be complacent in the way we talk and write about vaccines, discuss vaccines, and we must take our clients, the public out there seriously and hear their voices, listen to their questions.”

Republished from Spotlight under a Creative Commons licence.

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