The South African Health Products Regulatory Authority (SAHPRA) has officially been accepted as a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), following an ICH assessment of compliance with requirements for membership, including a formal presentation outlining SAHPRA’s interest, progress, and milestones in implementing ICH principles.
The ICH is a unique global body that brings together regulatory authorities and the pharmaceutical industry to align scientific and technical standards for the registration of medicines. Since its establishment in 1990, it has evolved to support an increasingly globalised pharmaceutical environment. Its mission is to promote worldwide harmonisation to ensure that safe, effective, and high-quality medicines are developed and registered efficiently. This harmonisation is achieved through the development of ICH Guidelines, which are formulated through scientific consensus between regulators and industry experts. Successful adoption relies heavily on regulators’ commitment to implement these final Guidelines within their national systems.
The ICH Assembly met in person on 18-19 November 2025 in Singapore, in parallel with meetings of 12 Working Groups and preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee (SC).
“ICH is delighted to welcome NAFDAC, Nigeria, and SAHPRA, South Africa, as new ICH Members, in addition to two new Observers: DIGEMAPS, Dominican Republic, and Philippine FDA, Philippines, bringing ICH to a total of 25 Members and 41 Observers.”
Welcoming SAHPRA’s membership, CEO Dr Boitumelo Semete-Makokotlela said: “This is a significant milestone for the South African Health Products Regulatory Authority. Membership of the ICH strengthens our commitment to the three pillars of safety, quality, and efficacy, while ensuring that our processes remain resource-efficient. This development allows SAHPRA to benchmark its regulatory practices against global best practice for the benefit of all people living in South Africa.”
The cancellation of US aid funding to South Africa is harming the country’s HIV response. Source: Unsplash CC0
By Marcus Low and Nathan Geffen
The number of HIV viral load tests is significantly lower than expected, according to an analysis of data from the National Health Laboratory Service which Spotlight and GroundUp obtained through the Promotion of Access to Information Act.
The number of HIV viral load tests recorded by the National Health Laboratory Service (NHLS) is significantly less than expected since February 2025. We are aware of no compelling reason to explain this except the withdrawal of US aid.
All patients in the public health system with HIV are supposed to get viral load tests regularly, usually once a year. These tests are used to determine if HIV is being suppressed successfully in their blood using ARV medicines. If the number of viral load tests declines, it likely indicates either that patients are being lost to the public health system, they are being monitored less diligently, or the system for recording viral load tests has become less accurate. Any one of these would imply a serious hit to South Africa’s public sector HIV programme.
GroundUp and Spotlight used the Promotion of Access to Information Act to request, among other things, viral load test numbers from the NHLS. We were provided a spreadsheet with the number of tests per month for each province from January 2015 to September 2025.
The current US Administration began taking steps to reduce US aid across the world after Donald Trump was inaugurated as president on 20 January 2025. Billions of rands have been withdrawn from South Africa. This caused some services, especially for vulnerable people — including gay men, sex workers and trans people— to close almost immediately, such as the Ivan Toms Centre in Cape Town and Wits University facilities in Johannesburg. US aid also funded support systems, such as data collection.
Public health experts have accused the government of being in denial about the consequences of the withdrawal of US aid. Health Minister Dr Aaron Motsoaledi has responded defiantly. In May, he stated that a record number of people had been initiated on ARVs over the previous months, a claim disputed by epidemiologists.
We asked a biostatistician to examine the NHLS data we received. She analysed the change in viral load tests by month and province over time. She found that the number of viral load tests for the period February to September this year is statistically significantly lower than what one would expect based on previous years. This confirms the view of public health experts: the withdrawal of US aid from South Africa has hit the HIV programme badly.
The decline in viral load numbers was previously reported by the Daily Maverick and Reuters for March and April. This was inevitable given the sudden withdrawal of US aid. But the new data shows that the decline has been sustained until September. The decline has occurred in every province except Limpopo.
How Viral Load Testing Performed Against Expectations, Feb–Sept 2025
Province
Predicted
Actual
Difference
% Difference
p_value
Eastern Cape
545,061
463,510
-81,551
-15
0.0007
Free State
285,423
234,671
-50,752
-18
0.0002
Gauteng
1,210,891
1,006,833
-204,058
-17
0.0002
KwaZulu-Natal
1,475,360
1,284,008
-191,352
-13
0.0001
Limpopo
419,357
441,314
21,957
5
0.1550
Mpumalanga
532,713
450,495
-82,218
-15
0.0007
North West
326,907
292,150
-34,757
-11
0.0002
Northern Cape
64,855
58,746
-6,109
-9
0.0017
Western Cape
324,074
290,011
-34,063
-11
0.0205
National
5,184,640
4,521,738
-662,902
-13
0.0003
*This table presents the expected and actual numbers of viral load tests conducted by the National Health Laboratory Service in South Africa from February to September 2025.
By looking at the change in viral load tests since 2015, a biostatistician estimated the number of viral load tests that there should have been for the period February to September 2025 using a standard linear regression model. She found that the actual number of tests declined significantly. A p-value less than 0.05 is considered statistically significant. Except for Limpopo, the p-values are substantially less than 0.05 for every province. The analysis takes into account that the NHLS suffered a data hack in 2024, and consequently, there is missing data for a few months.
An even simpler analysis also raises red flags. The absolute number of viral load tests conducted from February to September 2025 (4,521,738) is slightly lower than it was over the same period in 2023 (4,554,463) (due to a cyber attack, the NHLS’s 2024 figures are not a reliable comparison). Given that the number of people on HIV treatment is expected to increase over time and that everyone should be getting at least one viral load test per year, one would expect the number of viral load tests to have increased by a few hundred thousand since 2023.
These results show that the HIV programme has been set back. It is possible that tens of thousands of people have been lost to care. Also possible is that they are disproportionately the most vulnerable patients treated at specialist US funded facilities that closed as a consequence of the funding cuts.
Nevertheless the HIV programme is still successfully treating millions of people and South Africa is far better off than other African countries, such as Mozambique, whose response to HIV is almost entirely paid for with foreign aid.
Fewer patients have viral rebound. But is it a silver lining?
People with HIV who are on ARVs should have, after a few weeks, an undetectable amount of virus in their blood. This is what the viral load test measures. But if the ARVs stop working or a person stops taking their ARVs regularly, the virus will rebound in their blood.
The NHLS counts the number of viral load tests for which patients have more than a thousand copies of HIV per drop of blood. For these patients, the virus has rebounded in their blood.
The percentage of viral rebound cases has come down in 2025.
This might be because the standard ARV regimen has improved. A drug called dolutegravir is now part of the regimen, and it is known to do a better job of suppressing HIV than the drug it replaced a few years ago. This would be the good-news explanation, a silver lining in the data.
But it’s also possible that it’s because vulnerable patients treated in specialist clinics funded by US aid are more likely to have viral rebound and they are the ones who have been lost to the HIV programme. This would be the bad-news explanation.
At this point, we don’t have data to know which explanation of the viral rebound improvement is correct. The situation also varies substantially by province. The real picture might be a complex interaction of multiple factors.
The NHI Act is facing a slew of legal challenges from multiple organisations. For this special series, Spotlight combed through court papers, and spoke with legal experts to pin down what specific arguments litigants are betting on. In part one, we focused on the claim that the scheme is unaffordable and therefore unreasonable. Here, in part two, we discuss the argument that the NHI will unjustifiably compromise people’s right to access healthcare services.
Since the National Health Insurance (NHI) Act was signed into law by President Cyril Ramaphosa in May 2024, eight different groups have challenged it in court, with some filing multiple applications.
One core argument which appears in different ways across many of these submissions is that under the NHI, people will have access to fewer health services, or simply a reduced quality of care, than what they currently have.
If this was true then the NHI could be in violation of Section 27 of the country’s Constitution, according to which government has to do what it can to achieve the “progressive realisation” of the right to healthcare services (along with the right to food, water and social security). Courts have often interpreted this to mean that the government not only has to take active steps to advance people’s access to healthcare, but also that it should avoid doing things that might limit their existing rights.
Sasha Stevenson, who heads the public interest law clinic SECTION27, explained that the Constitution uses the phrase “progressive realisation” because of a “recognition that not everything can be perfect straight away, so the government needs to take steps to move toward full realisation of certain socioeconomic rights”. She added: “What that means logically is that you can’t move backwards.”
There is however some wiggle room, said Stevenson. This is because the Constitution only expects the government to take “reasonable” steps that are “within its available resources”, she said.
Thus, if the government was cash-strapped and able to show that it simply couldn’t afford to maintain its current levels of health expenditure without seriously compromising other core rights, then it may be able to take steps backward without violating the Constitution. Stevenson argued that, at its core, the key idea is simply that the state must fully justify what it is doing.
To show that the NHI Act violates Section 27 of the Constitution, litigants will need to prove that it not only limits people’s right to healthcare, but that the government hasn’t provided good enough reasons for why it is doing this.
But why are litigants arguing that the NHI would limit people’s right to healthcare in the first place? Let’s start with medical scheme members.
Cutting out medical schemes
Section 33 of the NHI Act states that once the scheme is fully implemented, medical schemes will only be allowed to cover top-up health services that aren’t covered by the NHI. In addition, the Act requires “mandatory prepayment”, meaning people will have to pay to be covered by the NHI, whether or not they want to join.
Thus, unless someone was able to afford both the mandatory prepayment for the NHI, and complimentary cover from their medical schemes, they would have to switch to relying solely on the NHI for their medical coverage.
This is an issue for the Board of Healthcare Funders (BHF), which represents the medical insurance industry, and was one of the first groups to challenge the NHI in court.
“When you look at what medical scheme members are entitled to now versus to what they’re entitled to under an NHI scheme, it’s a regressive process,” Neil Kirby, who heads the healthcare and life science practice area at Werksmans Attorneys, which represents BHF, told Spotlight.
“You probably would be entitled to less under an NHI scheme than you would under the current regime,” he said.
Of course, at present we don’t yet know exactly what health services the NHI will cover, as the package of benefits has not yet been detailed. It thus may be difficult for courts to assess this claim.
When asked about this, Kirby said: “The current assessment by various economic experts is that if one were to price the value of the current basket of prescribed minimum benefits [the services which medical schemes have to cover]… and spread that cost over the entire population covered by NHI, the NHI would be entirely unaffordable.”
As a result, he said: “There would have to be some degree of compromise in respect of the benefits to be provided under NHI in order for the state to afford to purchase those benefits”. In other words, they’d need to offer less than what medical schemes currently cover.
In response to this, the National Health Department’s NHI lead, Dr Nicholas Crisp, denied that people’s coverage would be compromised under the NHI. In a conversation with Spotlight, he argued that the NHI would not need to incur the same total payment obligations as medical schemes in order to cover a comprehensive package of health services. This is given that it could purchase services more efficiently, he said.
ANC President Cyril Ramaphosa, with Minister of Health, Dr Joe Phaahla and his deputy Dr Sibongiseni Dhlomo, during the signing into law of the National Health Insurance Bill. (Photo: @MYANC/Twitter)
Crisp justified this on several grounds. One is that private health providers are currently accused of overservicing clients, which he argues could be rectified under the NHI.
For instance, Crisp pointed to the Competition Commission’s Health Market Inquiry report, which found that private health facilities are reimbursed for each consultation, operation or other service that they provide. The report found that this “creates an incentive for providers to over-service patients, to over-invest in generously remunerated services, and under-invest in poorly remunerated services [even if they have a positive impact on patient outcomes]”.
Under the NHI scheme, a different reimbursement model would be used to cover health providers both at private and public health facilities. For instance, in the primary healthcare sector, the NHI would rely on capitation. This means that health providers would be provided a fixed fee for each patient, rather than for each individual service, removing the incentive to overservice, and thus overcharge.
Crisp also argued that the government is able to procure medicines and other health services at lower prices than the private sector partly by buying in bulk. Additionally, he noted that billions of rands are reportedly lost in fraud, waste and abuse within the private health sector, due for instance to fraudulent medical claims.
According to Crisp, the NHI fund would be able to save on all of these unnecessary costs.
Pushing back on this view, Professor Alex van den Heever, from the Wits school of governance, told Spotlight that there was no reason to think the state could purchase cover more efficiently than the private medical schemes.
In the public sector, he said that “whether you have a [national] monopoly like Eskom, or a public monopoly in a province like the Gauteng Department of Health, they hardly spend their money efficiently”. Van den Heever added: “For Tembisa hospital to lose R2 billion and not get a cent back in terms of actual products is an indication of the risk.”
He was referring to a damning report by the Special Investigating Unit which confirmed large-scale looting to the tune of around R2 billion meant for patient care at Tembisa Hospital in Gauteng’s East Rand. Their investigation zoomed in on nine criminal syndicates, with three of them pocketing nearly R1.7 billion. The SIU found that R122 million in kickbacks were paid to at least 15 current and former health department officials.
“So you have to have some real evidence that [the state would] be able to procure services more efficiently, and there’s no evidence. All the historical evidence suggests they’d do worse,” Van den Heever said.
Does the state have good reasons?
If litigants are able to show that the NHI was regressive for people on medical schemes in the sense that it diminished their rights, the courts might still decide that the government had provided a good enough justification for why these limitations are reasonable.
But according to Van den Heever, the government has thus far categorically failed to do this.
“From the green paper to the white paper to the [NHI] bill, there is not a single technical document that provides a clear rationale for Section 33 [the restriction on medical schemes],” said Van den Heever. Overall, the very question about what specific problems the NHI is trying to solve and how it would do this remain elusive.
He added that one public health professor had submitted court papers in support of NHI which argued that the existence of the private health sector undermines the public sector, for instance by hoarding doctors and specialists. Yet according to Van den Heever, “no technical report has ever been produced” which provides evidence for that claim.
Additionally, he noted that doctor shortages at public facilities are evidently not driven by private sector hoarding but by financial constraints emanating from mismanagement and corruption. This prevents public hospitals from hiring people who are available for work. (Previous Spotlight reporting has also suggested that the shortage of doctors in the public sector is driven by a lack of funding, rather than a lack of doctors.)
Similarly, the Hospital Association of South Africa (HASA) argued in court papers that the NHI Act’s restrictions on medical schemes serves “no rational, reasonable or economic purpose”.
The association also argued that there are no examples of health systems that impose these restrictions, aside from a few provinces in Canada, and thus Section 33 of the NHI Act is clearly “not a requirement for a successful national health system aimed at [universal health coverage]”.
Defending the restriction on medical schemes, Crisp said that if two different streams of health financing are allowed to continue, then so will inequity. He also stated that single-payer health systems funded by the state are not unusual, even if their exact form differs across countries.
Limiting the rights of public sector users
In addition to the arguments that the NHI Act will unjustly restrict the rights of medical scheme members, some have also argued that it will be regressive for public sector users.
One organisation making this argument is the Treatment Action Campaign (TAC). It has applied to be a friend of the court in the dispute between the South African Medical Association (SAMA) and the government. The TAC argued that the governance provisions within the NHI are so weak that they threaten the entire health system, including for those relying on government health facilities.
Stevenson, whose organisation SECTION27 is represents the TAC, said that checks and balances within the governance of the NHI fund are deficient, leaving it vulnerable to corruption and mismanagement.
Van den Heever, who is serving as an expert in the SAMA case, seconded this concern. He also said that the NHI ultimately centralises the management and purchasing of healthcare services under national institutions. This introduces inefficiencies that will compromise patient care at government facilities, he argued.
“Healthcare is [a sector] where the purchasing and management [should be] decentralised,” he said, largely because different communities have different health needs.
Even in the United Kingdom, said Van den Heever, the responsibility for the National Health Service, which provides the majority of medical services, is devolved across England, Wales, Scotland and northern Ireland, with semi-autonomous trusts, boards and hospitals in each country having a major say in operational decisions.
Van den Heever argued that not only would the centralisation of health under NHI be highly undesirable, but the actual transition to this system from one in which provinces are responsible for healthcare would be enormously disruptive, impacting patient care.
Asylum seekers compromised by NHI
An additional argument concerns the rights of asylum seekers and undocumented people, a central concern for SAMA and the TAC.
Stevenson explained that under our current system, all people, including asylum seekers and undocumented migrants, have the right to free primary healthcare services in the public sector. Just like ordinary citizens, asylum seekers also have the right to access public hospitals on a means-tested basis (meaning your level of subsidisation is determined by what you can afford).
In addition, pregnant and lactating women, as well as children under six, are entitled to all services regardless of documentation status, and the government is compelled to screen, test and treat anyone with HIV.
Under the NHI Act, all of these rights are compromised for asylum seekers and undocumented migrants. This is because Section 4 of the NHI Act states that these groups are only covered for emergency care and for services related to notifiable conditions. The country’s list of notifiable conditions includes diseases like cholera and pulmonary TB, but excludes HIV, diabetes and many other common diseases.
Stevenson argued that this not only compromises the rights of individual asylum seekers, but makes for terrible public health policy.
“It essentially means dropping part of our population off the HIV programme,” she said.
“It would also mean we’re waiting more and more for emergencies, because people can access care [at the point of emergency] but not at a primary healthcare level. So you can’t go and get yourself checked for diabetes… But when your foot is gangrenous [a symptom of untreated diabetes] and needs amputation then you’re in an emergency situation.”
Overall, the Act in its current form constitutes a clear regression for asylum seekers, said Stevenson, and the government has provided no comprehensive justification for why it is excluding this group. If the government wanted to justify the exclusion of migrants on the basis that it is too costly to cover them under the NHI then they “have to show the numbers”, Stevenson said.
Thus far, they haven’t done so.
“There has been no assessment of the so-called burden of migrants in the health sector, let alone how many people fit into which category or how much money is spent on services for people,” said Stevenson, “Instead, there has just been this persistent scapegoating, and these broad statements about the burden.”
Court documents submitted by SAMA have made similar allegations.
“There is no reliable study which shows the extension of the NHI to foreigners will have a significant effect on the affordability of the NHI,” it argued, noting that in fact the converse may be true, as the contributions of foreigners to the economy may outweigh the costs of providing them healthcare.
Asked about this, Crisp said that they were aware of the issue, and that while it was a complicated matter, the state would ultimately have to ensure healthcare for all people, in line with its domestic laws and international agreements.
Disclosure: SECTION27 is mentioned in this article. Spotlight is published by SECTION27, but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council and subject to the South African Press Code.
Potential partnerships between the public and private healthcare sectors have largely not been harnessed. Photo by Sora Shimazaki
By Ufrieda Ho
Government and the private sector could work together much more effectively to improve healthcare services in South Africa, but the potential of such a partnership remains largely untapped, delegates heard last week at the Hospital Association of South Africa conference.
Healthcare funding in both the public and private sector is headed towards a sustainability crisis, delegates at this year’s Hospital Association of South Africa (HASA) conference heard. But potential solutions such as pooling resources, linking services and partnering smarter has proved to be elusive and far from simple to implement.
The conference was held against a backdrop of ongoing legal action brought by HASA in March this year opposing the passing of the National Health Insurance (NHI) Act. As previously reported by Spotlight, this is one of eight challenges to date against the Act since it was signed in May 2024.
HASA’s case centres on the affordability of NHI and its potential impact on the private healthcare sector.
Dr Dumisani Bomela, Chief Executive Officer of HASA, wrote on their website in September: “Government must view private healthcare as a strategic partner, a national asset that can offer significant ideas to resolve the national health delivery crisis. Private healthcare, on the other hand, faces challenges, some of which were identified in the Health Market Inquiry.”
The final report of the Competition Commission’s Health Market Inquiry was published in 2019, but as yet, most of its recommendations to bring private healthcare costs under control have not been implemented by government. Most medical aid schemes recently announced well-above-inflation increases for 2026 – such above inflation increases have been the norm for over a decade.
In February this year, government took what appeared to be a first step toward getting a grip on private sector healthcare costs when it published draft regulations that would, among others, have set up structures to facilitate tariff-setting. The way these structures were to be set up (a block exemption from the Minister of Trade, Industry and Competition was used to create new structures in the national health department) however raised questions about how well thought-through the plan was. This week, Department of Health spokesperson Foster Mohale told Spotlight that “stakeholders rejected the regulations and the legal opinion was that the draft regulations conflated roles so must be redrafted”. He said the department is busy drafting a new regulation that will work in tandem with a block exemption.
“Not only has the country spent nearly two decades in a fruitless debate about the NHI, but it appears that those in charge of the healthcare system have prioritised stagnation over progress in health reform,” Bomela wrote in September.
Last year’s HASA conference made headlines when an alternative to NHI was proposed that would, among others, see medical scheme membership be made compulsory for people earning above certain thresholds – a move it was argued would swell medical scheme membership, bring down the cost of scheme membership (through younger and healthier people joining), and reduce pressure on the public sector by diverting millions of people to the private sector. While there was some engagement with the Presidency on the proposal and it seemed for a while that there might be some flexibility on the design of NHI, the ANC eventually rejected the idea that any concessions would be made on the design of NHI. Since then, some draft regulations relating to the NHI Act have been published for public comment. Even though it is widely acknowledged that NHI is a long-term project, indications are that government intends to continue on the course set out in the NHI Act.
Better ways to pay for healthcare?
The two-day conference in Sandton this year again included speakers’ take on alternatives to NHI and ways to reform how healthcare is paid for. There was also discussion of the opportunities to leverage advances in artificial intelligence, the use of targeted therapies to remove more of the hit-and-miss of treatment plans, and better use of centralised data to speed up accurate diagnosis and be more helpful to patients in navigating the healthcare system.
At the same time though, speakers reiterated the urgency to break from the trap of talks that don’t come with action and for public-private collaborations to start delivering for more people. Several speakers did not mince their words when describing the scale and depth of the country’s healthcare crisis.
“Healthcare in South Africa is broken, in fact, it is in crisis. We are witnessing, if not participating in, the quickening implosion of our health system,” said Dr Biancha Mentoor, a health policy manager at Netcare.
“While predicting great strategy, we are just rearranging the deck chairs on the Titanic.”
In her address, Mentoor singled out poor leadership “that is out of touch with the people it is supposed to serve” as one of the biggest stumbling blocks.
“We see more homogenous leadership demographically, and it’s leadership with a preference for more established ways of thinking about and doing things in a country facing different challenges,” she said.
Mentoor’s “alternative” tackled the need for greater diversity in leadership, including gender diversity and intergenerational diversity. She also called for private sector players to organise better and be better aligned for effective cooperation.
The Western Cape mapping project
Conference delegates also heard of a collaborative project in the Western Cape that is showing some promise. Actuary Barry Childs, from Insight Actuaries & Consultants, and Suzanne Daniels, deputy director for compliance, billing systems, training and costing in the Western Cape Health Department co-presented on their work done in the Western Cape to map data, streamline data collection, and improve data analysis in order to establish diagnosis-related group (DRG) costing models as envisaged under NHI. They mapped four years of financial data from major hospitals and used this to inform the next steps for refining cost estimates and to have better case mix comparisons.
A DRG payment approach is a reimbursement model for hospital services to determine fixed fees to be paid for treatments. It categorises patients into groups based on diagnosis and the procedures and treatment patients will typically need. It is meant to be a way to standardise payments and to control costs. Unlike with a fee-for-service model, where a fee is paid for each consumable and service delivered, DRGs aim to set a flat rate for an entire treatment. Under a DRG model there might for example be a flat rate for a vaginal delivery, whereas under a fee-for-service model costs will depend on factors such as which scans were ordered and how many consumables were used in a particular case.
Daniels said: “One of the pillars to this is quality care and one of the pathways to quality care is understanding our healthcare cost, because in doing so, we can inform equitable resource distribution, and this is to guide efficiency measures.”
Childs warned though that time is being wasted. He said he had worked on versions of a DRG roadmap since around 2010, pointing out that the long limbo continues to keep the ideals of universal healthcare from being realised.
“This has been under discussion for a long time, and unfortunately, at a national level, the overall focus has been on NHI Act and NHI Bill and very little reform has been done on the ground,” he said.
Childs and Daniels said their showcase of the successes and insights from the Western Cape mapping project could offer other provinces a guide to get out of the starting blocks in standardising procedure and hospital codes, collecting better data and getting a clearer grip on costs and grouping of costs in order to move towards better healthcare funding reforms.
A model that’s working at one Gauteng hospital
Ahead of the conference, Spotlight spoke to group chief executive of Life Healthcare, Peter Wharton-Hood, about the company’s partnership with the Gauteng Department of Health. The partnership involves Eugene Marais Hospital (a Life hospital) taking oncology patients from Steve Biko Academic Hospital (a state hospital).
This comes in the context of the Gauteng health department being taken to court by the Cancer Alliance in a drawn-out legal battle to compel the department to review and update the waiting list of cancer patients in the province and also to draw up and submit to the courts their plans on how they intend to ensure cancer treatment for people who need it. This includes partnerships with the private sector. (See our previous reporting on the litigation here)
Wharton-Hood said they are not informed whether or not the patients they receive are on the Gauteng department of health’s cancer waiting list or backlog list.
However, to date only 34 patients from the public sector have benefitted with this diversion programme at Eugene Marais, with another 10 people about to start treatment. Wharton-Hood said it could and should be many more patients.
“We’ve got a whole care pathway that is up and running. The treatment protocol follows the national guidelines, so there is no compromise to care. The patients are integrated into the daily schedules running in the hospital. And government is also paying us on time. This is a model that is working, so the question is why only 34 patients? We can do more,” he said.
He added that the public and the private health sector represent two vital assets and if they worked together more patients could benefit. However, as it stands, the full potential of these partnerships is simply not being harnessed.
Wharton-Hood said there continues to be a peculiar government reluctance to buy more services from the private sector. It could be win-win-win deals, he said. For the state, it would ease congestion and backlogs at state hospitals. For private facilities, it would push up optimal utilisation and boost revenues. For patients, it would be treatment and care with fewer delays.
He added: “We’ve got something that’s working with Eugene Marais Hospital taking oncology patients from Steve Biko Academic Hospital. It should be a model that is scaled up and applied to other disciplines. If it’s good for oncology, it could be applied to renal dialysis or to orthopaedic cases, for example. The question is why this isn’t the case, why is government not entering into more of these deals when there are people we know are not getting the care they need?”
#InsideTheBox is a column by Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. (Photo: Supplied)
By Andy Gray
In several countries, the public is given an opportunity to share their views with regulators before new medicines are registered or to engage with those choosing essential medicines. In South Africa, however, opportunities for such public participation remains limited. In his latest #InsideTheBox column, Dr Andy Gray takes a look at how public participation is handled elsewhere and how it could be improved here.
One of the rallying cries of patient and community-based organisations has long been “nothing about us, without us”. The “patient voice” is, however, not always heard in medicines selection or medicines regulation.
How it works in the US and Europe
Recent highly contested medicines regulatory decisions in the United States, such as the warnings about paracetamol use in pregnancy, have highlighted the role of advisory committees to the Food and Drug Administration (FDA). The FDA relies on a number of such committees to provide advice on regulatory questions, such as whether to approve a new medicine or how to manage emergent safety signals. The FDA usually follows the advice provided by these independent structures, but is not bound to do so.
The fact that advisory committees meet in open session, and that their recommendations are transparent to the public, means that the final decision by the FDA can be contrasted with the scientific advice. The curricula vitae of advisory committee members are posted on the FDA website and updated annually. Critically, when an advisory committee meeting is scheduled, the date and time is announced at least 15 days in advance of the meeting, and this serves as an invitation to interested parties to register to make oral submissions during the Open Public Hearing portion of the meeting.
In addition to providing opportunities for public engagement in this manner, the FDA has also operated a Patient Representative Program since 2024. FDA Patient Representatives are appointed, provided with training, and may then engage with the scientific and other expert members of the advisory committees. Among the criteria applied in their selection are personal experience with a particular disease as a patient or primary caregiver, knowledge about the treatment options and research in that area, and the willingness and ability to communicate in public, as well as being objective while representing the concerns of others affected by the disease.
Similar mechanisms have been put in place in Europe. The European Medicines Agency (EMA) has enabled the appointment of patients as members of its management board and scientific committees. In addition, the EMA Patients’ and Consumers’ Working Party provides a venue for ongoing engagement. The EMA engagement framework explicitly aims to ensure “access to patients’ real-life experiences of living with a condition, its management and the current use of medicines, complementing the scientific evidence provided during the evaluation process” and “the generation, collection and use of evidence-based patient experience data for benefit-risk decision-making”.
How it works in South Africa
Section 3(9) of the Medicines and Related Substances Act, 1965, instructs the chief executive officer of the South African Health Products Regulatory Authority (SAHPRA) to appoint advisory committees. The wording is peremptory, but also broadly enabling: “The Chief Executive Officer shall, in consultation with the Board, appoint committees, as he or she may deem necessary, to investigate and report to the Authority on any matter within its purview in terms of this Act.” Provided there is consultation with the Board of the Authority, the number of committees and their membership is left to the CEO to decide.
To date, however, there has been no deliberate effort to include patient or consumer representatives on any of the advisory committees.
More importantly, meetings of the committees are not open to the public, nor are their recommendations to the regulatory authority placed in the public domain. The “patient voice” is therefore potentially missed, and stakeholders are unable to determine when or how final decisions taken by the Authority may differ from the recommendations made by the technical advisory committees. In that sense, SAHPRA is no more transparent than its predecessor the Medicines Control Council, which also laboured under the same antiquated secrecy provision in the Act. Section 34 of the Act is actually labelled “Preservation of secrecy”.
Similar concerns with medicines selection
Medicines regulators determine whether medicines should be allowed onto the market and how those should be controlled. Similar dynamics are at play in determining which medicines are “essential” and should be procured or reimbursed by health systems.
At a global level, the World Health Organization (WHO) updates its Model List of Essential Medicines every two years. The Model List is a starting point for many countries’ efforts to develop national essential medicines lists, guiding procurement in their public sectors. Although the expert committee responsible for this work does not explicitly include patient representatives, all proposals submitted are placed in the public domain, as are the reviews conducted, and an account of the final decisions. On the first day of the meeting, an open session is held at which stakeholders are invited to apply to present.
One of the most trusted medicine selection bodies is the UK National Institute for Health and Care Excellence (NICE), which also has a deliberate process for stakeholder engagement at multiple steps in its guideline development. For example, right at the outset, this invitation is issued: “NICE invites all stakeholder organisations to attend a scoping workshop. You will be sent a first draft of the scope, which will be discussed at the meeting. We encourage you to send someone who knows about and can represent patients and carers’ interests.”
Medicines selection in the South African public sector is evolving, embracing the challenge of health technology assessment. While there are as yet no patient representatives on either the Expert Review Committee or the National Essential Medicines List Committee, there are opportunities for stakeholder engagement with draft guidelines and increasing transparency, with medicines evaluation reports posted on the Department of Health website.
Full medicine reviews follow an evidence-to-decision framework that was first piloted during the height of the COVID-19 pandemic. One of the questions posed reads: “Is there important uncertainty or variability about how much people value the options?” This question is aligned with what the WHO Handbook for Guideline Development refers to as “values and preferences”. For example, the WHO guidance calls for evidence of the “values and preferences of the people receiving the intervention or experiencing the outcomes the intervention can affect”. While that evidence may sometimes be reported in the scientific literature, all too often it is lacking.
Ultimately, “nothing about us, without us” should not only be a demand made by patients, but also by those who care about the quality, reliability and acceptability of medicines selection and regulatory decisions. Improving the transparency of decision-making processes is critical, but so is creating, promoting and protecting the spaces for an effective “patient voice”. Doing so is a critical investment in building trust, which is so easily eroded.
*Dr Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is part of a series of #InsideTheBox columns he is writing for Spotlight.
Disclosure: Gray is a member of South Africa’s National Essential Medicines List Committee and co-chairs its Expert Review Committee.
Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.
Most medical devices are used in healthcare settings but some like bandages, thermometers, condoms, and blood pressure monitors are used at home. Photo by Mockup Graphics on Unsplash
By Catherine Tomlinson
Unlike with medicines, and with a few exceptions, South Africa’s regulator does not assess whether diagnostic tests and other medical devices on the market are safe and work as they are supposed to. The regulator has however started down a road that should eventually lead to the regulation of all medical devices in the country.
From scalpels to surgical robots, finger-prick diagnostic tests to MRIs, thermometers to wearable AI-powered health monitoring devices, bandages to prosthetics: the range of products classified as medical devices is vast.
Some medical devices are used briefly and then disposed of after a single use, while others are designed to stay in our bodies for long periods of time, such as implants to prevent pregnancy and pacemakers to help the heart beat regularly.
While most medical devices are used in medical settings, some, like bandages, thermometers, condoms, and blood pressure monitoring devices, are used at home.
The World Health Organization estimates that there are more than two million different types of medical devices used around the world. Given the enormous diversity of medical devices, it can be tricky to see what links all these products together.
One answer, and essentially the one used in South African law, is that it is the intended use of the device. A medical device is thus simply any device that is intended to be used to prevent, diagnose, monitor, or treat a disease, injury, or other medical condition.
Because medical devices are sold for medical purposes, they require regulatory oversight to ensure that they are safe to use and work as intended. But in South Africa, this regulatory oversight is not yet fully in place, and you can’t always trust that devices do what they claim to do, or that tests are accurate.
‘Inaccurate readings’
On a recent webinar hosted by FIND, an international non-profit engaged in the development of diagnostics for low resource settings, the chairperson of NGO SA Diabetes Advocacy, Kirsten de Klerk, told participants that “a lot of people assume that if a medical device is available for purchase, it has been correctly tested and approved for use” but “unfortunately, that’s not the case”.
De Klerk added: “I have unfortunately had community members sharing stories of life-threatening situations because of inaccurate readings” from continuous glucose monitors (CGMs). These are medical devices used by people with diabetes to monitor their blood sugar level.
To address the challenge of poor-quality CGMs on the market, South African diabetes advocates and FIND launched a tool to assist people with diabetes and healthcare providers to identify and use monitors that have been properly assessed for safety and functioning.
But what role does the South African Health Products Regulatory Authority (SAHPRA) play in ensuring the safety and effectiveness of medical devices used in the country, and what steps is it taking to better protect the public?
A mandate to regulate
Though medical devices aren’t yet registered, SAHPRA does have a legal mandate to regulate medical devices. The relevant legal requirements were introduced in the 2015 Medicines and Related Substances Amendment Act 14. Before the 2015 Amendment Act came into force in 2017, only electromagnetic or radiation-emitting medical devices were regulated in South Africa.
The 2015 amendments provided for the establishment of SAHPRA to replace the Medicines Control Council as the country’s health products regulator and expanded SAHPRA’s regulatory scope to cover all medical devices.
SAHPRA’s first big move towards regulating the medical device industry was to introduce requirements for medical device companies to be licensed as medical device establishments. Medical device companies were informed that they would need a medical device establishment license to operate in the country in a government gazette notice issued in 2017. (Manufacturers of the lowest risk products – Class A medical devices that don’t have a measuring function and/or are not required to be sterile – are currently exempt from the licensing requirements.)
Today, over 2 500 companies hold active medical devices establishment licenses from SAHPRA. In their applications for these licenses, companies must list the medical devices that they will manufacture, import, or wholesale in South Africa and the establishment licenses that they are granted are specific to the class of products that they are manufacturing or handling.
Medical devices are classed in four groups from lowest to highest risk products, based on the risk posed by the product to patients and the broader public health. Bandages for example are classed as low risk, while heart valves are classed as high risk. Using a risk-based approach allows SAHPRA to harmonise how medical devices are regulated in South Africa with international norms and will allow the regulator to prioritise review of high-risk products as it phases in requirements for registration of medical devices used in the country.
In addition to listing the devices that they manufacture, distribute, or wholesale, companies seeking medical device establishment licenses from SAHPRA are also required to provide a declaration regarding the quality management systems that they have in place.
Critically, however, the devices themselves are not yet being assessed by SAHPRA.
Dr Dimakatso Mathibe, senior manager of SAHPRA’s medical device unit, told Spotlight that more than 200 000 different medical devices are used in South Africa. While over two thousand companies hold active medical device establishment licenses, she explained that a single company may be importing over a hundred products. She noted that as SAHPRA has increased the regulatory requirements for operating in South Africa, some medical device companies have voluntarily withdrawn from the market.
ISO 13485 certification
SAHPRA’s second big move, which is now being rolled out, is the introduction of requirements for medical device companies to gain ISO 13485 certification verifying that they meet international quality management standards.
Medical device companies operating in South Africa can receive certification that they meet ISO 13485 standards from an international or local conformity assessment body that has been accredited to provide this certification.
When SAHPRA first introduced medical device establishment licenses, it did not require companies to have ISO 13485 certification, as it was concerned that enforcing this too quickly could disrupt access to medical devices in the country. This was in part due to the lack of local conformity assessment bodies accredited by the South African National Accreditation System (SANAS) to grant this certification at the time.
John Ndalamo, accreditation manager for SANAS’ certification programme, told Spotlight that six local conformity assessment bodies have now been accredited to provide ISO 13485 certification.
SAHPRA now requires that companies renewing their five-year medical device establishment licenses provide either proof of ISO 13485 certification or evidence that the company has begun the process of seeking this certification.
What about regulation of the actual devices?
While important strides have been made by SAHPRA toward regulating the medical device industry, medical devices themselves still remain mostly unregulated in South Africa.
What this means is that, as pointed out by SA Diabetes Advocacy, medical devices may currently be marketed in the country without an independent regulator confirming that they are safe to use and perform as advertised.
The registration of the over 200 000 medical devices in use in the country is a mammoth job. Mathibe said that when SAHPRA introduces requirements for the registration of medical devices, it will do so in a phased and transitional manner. She explained that the call-up of medical devices for registration will likely be phased by product risk classes and conditions. Presumably, SAHPRA will start with the highest risk products and work down from there.
Assessing feasibility
SAHPRA is conducting a feasibility study of its intended approach to register medical devices. Companies holding medical device establishment licenses have been asked to voluntarily participate in the study.
In documentation published for the feasibility study, SAHPRA indicated it plans to include 32 medical devices used for HIV and TB in the study. These will cover in vitro diagnostic tests, condoms, and X-ray devices used for TB screening.
SAHPRA also aims for half of the products included in the study to be manufactured locally and the other half to be imported. In doing so, SAHPRA can use the study to test its approach for registering products that are evaluated locally, as well as products assessed in other countries with which it has a regulatory reliance mechanism in place (meaning it can rely on regulatory evaluations performed in these countries).
How will safety and performance be assessed in the feasibility study?
Mathibe said that SAHPRA will not directly assess the safety and performance of medical devices in the feasibility study. Instead, this will be done by accredited conformity assessment bodies, which is the same approach used by regulators in Europe. The assessment made by the conformity assessment bodies will then be used by SAHPRA in determining whether a product should be approved for use in the country.
For medical devices already registered in jurisdictions with which SAHPRA has a reliance mechanism in place, like the European Union, Australia, and Japan, companies can submit evidence of such conformity assessments and marketing approval. SAHPRA can then use this information to help make its own registration decisions.
Devices that are not approved by a regulatory authority recognised by SAHPRA, must undergo a safety and performance assessment by a locally accredited conformity assessment body.
Mathibile said insights from the study will be shared with stakeholders next year, and the lessons will help inform how SAHPRA introduces medical device registration in South Africa.
Emergency authorisation of COVID-19 and Mpox medical devices
While SAHPRA has not yet registered medical devices, it introduced rules in 2020 for emergency authorisation listings for certain medical devices used for COVID-19 in South Africa, and it announced in 2024 that diagnostic tests for Mpox required approval from SAHPRA before they could be used in the country.
SAHPRA has thus “listed” multiple COVID-19 tests and two Mpox diagnostic tests as approved for use in South Africa. Khanyisile Nkuku of SAHPRA’s medical devices unit told Spotlight that the diagnostic products for COVID-19 and Mpox received interim Section 21 authorisation.
Section 21 authorisation allows for the use of unregistered products under certain conditions, including public health emergencies. This mechanism has been used by SAHPRA both to respond to the public health needs posed by COVID-19 and Mpox and to prevent the use of substandard products, which was a challenge faced in the early days of COVID-19.
Nkuku added while South Africa has had a relatively low number of Mpox cases, South Africa is a leading supplier of in vitro diagnostics to the rest of the continent, including countries facing large Mpox crises, and so SAHPRA shares the responsibility of ensuring that Mpox diagnostics used on the continent work properly and is working with the African Medicines Regulatory Harmonisation programme to review Mpox diagnostics.
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.
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.”
The Nelson Mandela-Fidel Castro medical training programme has been controversial from the start. It’s had high points, low points and many say it should have an end point.
Almost 30 years since the Cuba-SA doctors’ training programme was launched, it still divides opinion.
This year only Gauteng and North West interviewed candidates for the bursary programme that sends students from South Africa to be trained in the island country.
Critics say the dwindling interest shows the Nelson Mandela-Fidel Castro (NMFC) medical training programme has passed its sell-by date. But supporters remain committed to its ideals and some beneficiaries of the programme still think of it as the opportunity of a lifetime.
Between the differing views, what can be glimpsed is a chequered story of three decades of trying to transform South Africa’s healthcare system. The programme has its origins in the ANC’s political fraternity with Cuba and the laudable ideal of boosting doctors numbers in under-serviced rural areas. But it is also a tale of political inertia arguably blurring over time into a blind spot as conditions changed. In the background is the stranglehold of corruption and maladministration in the health sector, shrinking provincial health budgets, transformation of doctors’ training, and changing curricula.
One concern is that little is actually known about the programme’s impact. There is a lack of clear data on the costs and the numbers of doctors produced. Shockingly, for such a long-running programme, no comprehensive evaluation reports have been published, as far as Spotlight has been able to establish.
A comprehensive evaluation would weigh the benefits of the programme against its costs, compare it to other options for training medical doctors, and contextualise it within the current reality of very tight health budgets in provincial health departments – as it is, not all the doctors we are training are being employed.
Given this context, it is not surprising that the National Department of Health recommended a scaling back of the programme a decade ago. While most provinces have taken this advice, the Gauteng and North West health departments have instead pushed ahead with the programme.
Old histories and old allegiances
The agreement that put in place the NMFC medical training programme was signed in 1996, with the first cohort of students leaving for Cuba a year later in 1997. It was a mere two years into democracy and South Africa urgently needed to address gaps in the provision of healthcare. Under apartheid, services prioritised a white minority mostly in urban settings and healthcare had a strong slant towards hospital or tertiary care. There was a shortage of doctors and those with the least access to healthcare services were rural communities made up mostly of black South Africans.
Medical schools mostly had curricula designed for the status quo and there were few academic pathways for underprivileged students who had good marks at school but were not top achievers, leaving them overlooked for scholarships and bursaries.
So the new government looked to Cuba.
With its focus on primary healthcare, preventative medicine, and community-based training, the Cuban approach to healthcare ticked many of the boxes for the South African government then led by President Nelson Mandela.
Since the communist revolution in Cuba in 1959, it has provided free healthcare to all its citizens. While there remains some scepticism over data collection and interpretation, politicisation of medicine, and limited freedom to criticise the state, Cuba’s healthcare system is also widely lauded.
According to the Primary Health Care Performance Initiative, the country registers average life expectancy at 78 years (South Africa is at around 66), infant mortality dropped from 80 deaths per 1000 live births in 1950 to just 5 deaths per 1000 by 2013, and it has one of the world’s highest doctor to patient ratios. In 2021, it was at 9.429 physicians per 1000 people, according to World Bank Open Data. In the same year, South Africa tracked at 0.8 per 1000.
Since the 1960s, Cuba has established itself as a hub for training international fee-paying students and sending them back to their mostly lower-income countries as graduate doctors. One of its biggest universities, the Latin American School of Medicine, graduated over 30 000 students from 118 countries in the 21 years since it was established.
Another tick was Cuba’s staunch support for the ANC. SA History Online emphasises the depth of solidarity. It notes: “Cuba was a state in alliance with provisional governments and independent states in the African continent. Cuba’s military engagement in Angola kept the apartheid state in check, foiling its geopolitical strategies and forcing it to concede defeat at Cuito Cuanavale, and ultimately forcing both PW Botha and FW de Klerk to the negotiating table.”
Costs and benefits
The political and historical bonds sealed the doctors’ training deal. But from the start, the bursary programme, funded from provincial budgets, came under fire. The estimated costs over nearly three decades are massive, but details remain fuzzy.
Spotlight’s questions to the national health department were “answered” in one paragraph by department spokesperson Foster Mohale. “More than 4 000 [lower numbers are quoted by government in other instances] doctors have been produced through this medical programme since its inception. The programme is still relevant today and complements the local medical schools to produce more doctors. Qualified doctors have options of joining either public or private health sector,” he wrote.
But discrepancies have been showed up in government’s own figures. In November 2022, Haseena Ismail, the then DA member on the portfolio committee of health raised concerns about the quality of government data.
Minister of Health at the time, Dr Joe Phaahla, said the preparatory year, including a stipend, cost US$4400 per student, and each of the following five years cost US$7400 per student. But a separate table from the health department listed higher figures – US$8400 for the preparatory year and up to US$15900 per student by the fifth year. Added to this, the department listed annual costs of US$6472 per student for food, accommodation, and medical insurance. There were also expenses for two return flights over six years, plus the cost of 18 months of tuition and accommodation for clinical training at a South African medical school.
Phaahla said that as of November 2022, 3369 students had been recruited into the programme, and 2617 had graduated. However, he noted there was no information on what happened to these doctors or where they were employed. Each bursary student is required to work for the state for the same number of years for which they received funding.
South Africa has 11 medical schools, with the most recent addition of the North West University.
The programme also faced criticism over selection criteria for bursary candidates and for requiring two extra years of training compared to local medical programmes. Students spend one year learning Spanish, five years training in Cuba, and then return to South Africa for an additional 18 months of clinical training at a local medical school.
Controversies have dogged the programme over the years. In 2013, the Afrikaans newspaper Beeld reported that by 2009, only half of the students enrolled in the programme during its first 12 years had completed their studies.
In 2012, government ramped up the numbers of students it sent abroad. In 2018, this backfired when about 700 fifth-year students returned home only to find they could not be accommodated at any of the then 10 medical schools in the country.
It was around this time that the national health department issued recommendations for the provinces to phase out the programme.
Gauteng and North West
Despite all of the above, the Gauteng Department of Health continues to fund students – around 20 last year and an expected 40 this year.
Spotlight’s questions on this to the Gauteng health department went unanswered.
Compounding the administrative and planning blunders for returning students is the impact of deepening corruption and mismanagement in Gauteng’s health department. It has been under routine Special Investigations Unit scrutiny as well as coming under fire for service delivery issues such as the ongoing backlog of cancer patients lingering on treatment waiting lists. In March, the South Gauteng High Court in Johannesburg ruled that the Gauteng health department failed in its constitutional obligation to make oncology services available.
The situation in the North West is also bleak. Its health facilities are routinely facing medicine stock-outs and understaffing. Its health department is regularly struggling with accruals and paying suppliers on time.
Given all these challenges, it is puzzling that these two provinces in particular are so committed to sending students to Cuba, we understand at higher cost than for training doctors locally.
‘Better investments’
Professor Lionel Green-Thompson, now the dean of the faculty of health sciences at the University of Cape Town, was involved in managing returning students from the Cuba-SA programme between the mid-2000s and 2016. At the time, he was a medical educator and clinician at Wits University where he oversaw the 18-month clinical training of more than 30 returning students.
“Some of these students were among the best doctors that I’ve trained and I remain a stalwart supporter of the ideals of the programme. But at this point, there are better investments to be made, including directly funding university training programmes in South Africa,” he tells Spotlight.
“A programme that’s rooted in our nostalgic connection with Cuba and its role in our change as a country is now out of step with many of the healthcare settings and realities we face in South Africa,” says Green-Thompson.
He says a proper evaluation of the programme needs to be done.
There are also lessons to learn, he says, including a review of admissions programmes. How some students who enter a programme at 20% below the normally accepted marks, exit the programme as excellent doctors, he says offers clues to rethink how great doctors can be made.
Green-Thompson also suggests we need to ask why specialisation has become a measure of success for many doctors in South Africa, often at the expense of family medicine. This, he says, takes away from the impact doctors make at community healthcare level as expert generalists.
But changing the perspectives of healthcare professionals requires early and sustained exposure to working in community healthcare settings, says Professor Richard Cooke, head of the department of family medicine and primary care at Wits. Cooke is also director of the Wits NMFC Collaboration since 2018 and serves on the NMFC Ministerial Task Team.
“I’m not in support of further students being sent to Cuba for the undergraduate programme, because these students are not being trained in our clinical settings,” he says, speaking in his Wits capacity.
“The Cuban system is far more primary healthcare based than South Africa’s, but that doesn’t necessarily translate into these students ending in primary healthcare,” says Cooke.
And curricula at Wits is shifting, for instance, towards placing students at district hospitals for longer periods of time, rather than weeks-long rotations, he says.
“When students become part of the furniture at a hospital, they become better at facilitating, at critical thinking, problem solving, teamwork and collaboration,” Cooke says.
But making this kind of transformation in local training takes government funding and commitment. Students and doctors need to be attracted to the programme and need reasons to stay. But the money and resources to make this happen are simply not there – even as the Cuba training programme continues.
Cooke adds: “There hasn’t been definitive data on the NMFC programme. But even if the programme over 30 years has done well and met its targets, it’s not been cost efficient. What’s needed now is to leverage expertise and established partnership in different, more cost-effective ways like in research, health systems science and health science education.”
Up to three times more expensive?
Professor Shabir Madhi, dean of the faculty of health sciences at Wits, says the NMFC programme costs an estimated three times more than it costs to train a student in South Africa. This, he says, should be enough reason for a beleaguered health department like Gauteng’s to stop sending students to Cuba.
He also says: “Government is aware that it simply can’t absorb the number of medical graduates being produced.” Madhi says some trainee doctors are sitting at home while others trying to finish specialisations are being derailed.
Broadly, he pins the blame on the mismanagement of resources, including the department underspending R590 million on the National Tertiary Service Grant meant to subsidise specialised medical treatment at tertiary hospitals.
Madhi says universities have worked hard to close the gaps identified by the NMFC programme 30 years ago, but now student doctors are being let down by government not playing its role.
“Across the universities, there’s been a complete overhaul of the curriculum to be focused on primary healthcare. Students are also getting community exposure as early as first-year training,” he says.
He says that when it comes to admissions, the majority of students entering medical schools across the country are now Black South Africans, and additional changes have been made to the selection process. “We used to have a race quota, but in further revisions, we have introduced criteria that focuses on the socio-economic component, with 40% of the admissions coming from students in quintile 1, 2 and 3 schools [no-fee public schools],” he adds.
South Africa has 11 medical schools, with the most recent addition of the North West University – specifically focussed on rural health – and the University of Johannesburg in the pipeline to join the list. So the number of doctors being trained and graduating is increasing. Madhi estimates the total number being trained is above 900 per year for Gauteng alone.
The bottleneck of getting doctors into clinics and hospitals, he maintains, is not a shortage of doctors, but government’s inability to pay doctors’ salaries or to create functioning, well-resourced workplace environments.
‘You can’t put a price on that’
For Dr Sanele Madela, the ongoing challenges cannot detract from the goal to get doctors into communities – including through the NMFC programme. Today, he’s the health attaché at the Havana Mission for the NMFC training programme. Madela was also at one time a schoolboy with a dream of becoming a doctor.
Growing up in Dundee in KwaZulu-Natal, he remembers almost never seeing a doctor in his community. “Then when we did see a doctor, it was a white person or an Indian person and they never spoke our language – a nurse would have to translate,” says Madela who was part of the 2002 NMFC intake.
The six years abroad, he says, exposed him to very different reasons for becoming a doctor.
“When people finish medical school, they say thank God it’s over, but in Cuba people say thank God for the knowledge and information so they can give back to their country,” he says.
When Madela got back to South Africa, his journey eventually led him to work in Dundee district hospital. It was the same hospital where his mother had worked as a cleaner.
The NMFC programme, Madela says, still plays a vital role because of its objective to get more doctors into rural and township areas – “and you can’t put a price on that”, he adds, responding to criticism over the programmes comparatively high costs.
“We are used to seeing the NMFC programme from the point of view of adding human resources, but it’s also about the impact it makes for a community,” he says. It’s the impact of a community finally getting their own doctor. His argument is that, thanks to the NMFC programme, he got to be that person for his community.
By Matimba Ngobeni, Country Head: Value & Access, Novartis South Africa
28 July 2025, Johannesburg South Africa – South Africa’s healthcare system stands at a crossroads. Despite the promise of progress outlined in the Budget Speech and the Presidential Health Compact, the reality on the ground reveals persistent and growing barriers to accessing innovative medicines.
Economic pressures, funding constraints, and infrastructure gaps continue to undermine equitable healthcare delivery, particularly for vulnerable communities. What’s more, recent international developments—such as U.S. President Donald Trump’s cuts to funding that supported healthcare initiatives in South Africa—threaten to exacerbate these challenges, potentially limiting access to life-saving advanced therapies.[1]
Economic pressures
The cost of advanced therapies remains out of reach, and the structural inequalities in our healthcare system persist. While top-tier medical plans still provide access to advanced medicines, we are seeing a shift. Patients are moving to lower-tier plans or into the public system, simply because they cannot afford more. And with that shift, their access to advanced therapies disappears. [2]This is not a uniquely South African problem.
Globally, we see the same story repeat: private healthcare becomes a fortress that only those who can pay the toll may enter. Everyone else is left to rely on an overburdened public system, strained by funding shortfalls, infrastructure gaps, and critical workforce shortages. The public healthcare system, already overburdened, struggles to absorb this increased demand. Rising healthcare costs combined with limited household budgets create a perfect storm where affordability becomes the biggest barrier to accessing cutting-edge treatments.
Funding constraints and infrastructure challenges
Both private and public sectors face severe funding constraints. Innovative medicines, especially advanced therapies, come with high price tags that strain budgets and limit availability. At the same time, infrastructure and skills gaps hinder the effective delivery of these treatments. Investments in healthcare infrastructure, workforce training, and data management are urgently needed to support the growing demand for advanced therapies.
While it may seem like all hope is lost, the Presidential Health Compact offers a promising framework aimed at transforming South Africa’s healthcare landscape through infrastructure development and improved data surveillance[3]. However, it stops short of directly addressing access to innovative medicines. This gap underscores the need for stronger collaboration between public and private stakeholders to ensure that patients do not bear the financial burden alone.
Towards equitable access: Collaboration is imperative
Another way forward is through a robust, transparent Health Technology Assessment (HTA) process, where medicines are evaluated not only on their cost but on their ability to save lives, improve quality of life, and reduce the long-term burden on the health system.
Inclusive HTAs, where payers and pharmaceutical companies work together, are essential for reimagining access to advanced therapies. If we only look at the upfront cost of innovation, we miss the bigger picture of societal value.
Globally, risk-sharing models and outcome-based pricing agreements are helping bridge the affordability gap[4]. South Africa could benefit from more flexible legislation to enable these models, ensuring that innovation doesn’t remain locked behind prohibitive price tags.
South Africa’s healthcare future depends on what we choose to prioritise: short-term financial gains or long-term societal wellbeing. Too often, systems have been designed around protecting profits rather than protecting lives. Healthcare should never be a luxury. Yet in South Africa, and across much of the world, the reality is stark: exclusion is the norm, not the exception.
If we want a future where access to life-saving medicines is a reality for all, we need to break down the barriers of affordability, infrastructure, and policy inertia. And we need to do it together — governments, healthcare companies, funders, and civil society — because lives are at stake.
All hope is not lost. But we cannot wait for crisis to be our catalyst. The time for bold, collaborative action is now.
**About Novartis:**
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
Novartis South Africa (Pty) Ltd, Magwa Crescent West, Waterfall City, Jukskei View, 2090. Co. Reg. No. 1946/020671/07. Tel. No. +27 (0) 11 347 6600.
Disclaimer: The presentation may include data on formulations, products, indications, and dosages not yet approved by the South African Health Products Regulatory Authority. This information is not intended to be promoting nor recommending any formulation, indication, dosage, or other claim not covered in the approved Professional Information. Novartis South Africa (Pty) Ltd recommends the use of their products in accordance with the locally approved Professional Information. Views and opinions of speakers do not necessarily reflect those of Novartis.
#InsideTheBox is a column by Dr Andy Gray, a pharmaceutical sciences expert at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. (Photo: Supplied)
By Andy Gray
For over 20 years, the law has required that the Minister of Health issues regulations to govern the advertising of medicines in South Africa, but as yet no such regulations are in place. In his latest #InsideTheBox column, Dr Andy Gray considers what this means for the marketing of medicines in the country.
Anyone who has travelled to the United States will have been struck by the extent to which medicines, both those requiring a prescription and those that can be bought by consumers without a prescription, are advertised on television.
The situation in South Africa is quite different. While there are many advertisements for medicines shown on local television stations, only some are specific about the proprietary (brand) name of the medicine and its indications. Other advertisements focus instead on the indication (the reason for using the medicine), but do not identify it by name. Instead, viewers are urged to approach their pharmacies or medical practitioners. At a different time, an advertisement may be flighted which identifies a medicine, its strength, pack size and perhaps price, but provides no information about what the indication for the medicine is.
To what extent does this represent meaningful and justified regulatory control over pharmaceutical marketing?
Only two countries with effective medicines regulatory systems allow prescription-only medicines to be advertised directly to the consumer, these being the United States and New Zealand. Other countries, including South Africa, restrict the advertising of prescription-only medicines to the health professionals who can prescribe or dispense them. One of the key justifications for this restriction on the ability of the pharmaceutical industry to market their products is that direct-to-consumer advertising may result in more inappropriate prescribing, when prescribers are under pressure from patients demanding medicines they have seen advertised. Short television advertisements are unlikely to be able to convey a balanced account of the potential benefits and harms of medicines, especially those that are new to the market.
South African law contains an interesting variant to regulation in this area. General Regulation 42 issued in terms of the Medicines and Related Substances Act, 1965, allows medicines containing substances in Schedules 0 and 1 to be advertised to the public, but requires that those containing substances in Schedules 2 to 6 to be advertised “only for the information of pharmacists, medical practitioners, dentists, veterinarians, practitioners, and other authorised prescribers” or “in a publication which is normally or only made available” to such persons. While Schedule 0 medicines can be bought in any retail outlet, Schedule 1 and 2 medicines can only be obtained from a pharmacy, but not self-selected from a shelf. The justification for that particular cut-off is difficult to trace in any policy document. An amendment to the regulation was published for comment in February 2023, but the final regulation has yet to be issued by the Minister of Health.
‘Failure to follow through’
The fundamental problem, however, lies in a failure to follow through on the legislation previously passed by Parliament. Section 18C of the current version of the Medicines and Related Substances Act, 1965, contains a prescriptive instruction to the Minister. “The Minister shall, after consultation with the relevant industries and other stakeholders, make regulations relating to the marketing of medicines, medical devices or IVDs and such regulations shall also provide for Codes of Practice for relevant industries,” it states. From 2003 to 2017, the section read: “The Minister shall, after consultation with the pharmaceutical industry and other stakeholders, make regulations relating to the marketing of medicines, and such regulations shall also provide for an enforceable Code of Practice.” The expansion of the remit, to include medical devices and in vitro diagnostics (IVDs) was added by Parliament in 2008, but only took effect in 2017.
The wording is peremptory – the Minister “shall” – which leaves no room for delay. While the word “enforceable” has been removed, the very intent of a regulation is that it should be enforced. That no regulations have been forthcoming in more than 20 years is an extraordinary failure of governance.
That failure is compounded by another act of omission. Section 18A of the Act states: “No person shall supply any medicine, medical device or IVD according to a bonus system, rebate system or any other incentive scheme.” The law also enables the Minister to “prescribe acceptable and prohibited acts” in this regard, in consultation with the Pricing Committee. No final regulations have been issued since 2017. The Pricing Committee is established to advise the Minister on matters relating to the pricing of medicines, such as the annual maximum increase and the dispensing fees charged by pharmacists and licensed dispensing practitioners.
It is already an offence, in terms of section 29 of the Act, for any person to make “any false or misleading statement in connection with any medicine, Scheduled substance, medical device or IVD”. Regulation 42 also states: “No advertisement for a medicine may contain a statement which deviates from, with or goes beyond the evidence submitted in the application for registration of such medicine with regard to its safety, quality or efficacy where such evidence has been accepted by the Authority in respect of such medicine and incorporated into the approved information of such medicine”.
While these two provisions may prevent false or misleading advertising, they are limited in their scope. In particular, since no complementary medicines are yet registered by the South African Health Products Regulatory Authority (SAHPRA), none have an approved professional information (previously known as a package insert) or a patient information leaflet.
Industry self-regulation
The pharmaceutical and medical devices industries have not been idle during this period of government inaction. A non-profit, self-regulatory body, the Marketing Code Authority (MCA), has developed a Code of Marketing Practice, drawing on international guidelines. This code provides for sanctions when rules are broken, following adjudication of a complaint. Fines of up to a maximum of R500 000 can be levied for severe or serious offences, which would, for example, pose “safety implications for patients”.
However, as a self-regulatory body, the MCA cannot require membership by any licensed manufacturer. It means that those manufacturers which are not members of the MCA are not bound by the Code and cannot be sanctioned. The MCA therefore advocates that compliance with a Code should be a condition to get a license to operate as a manufacturer. The MCA has also responded to draft regulations on perverse incentives.
At a time when deliberate disinformation is being disseminated from many quarters, including from government authorities previously considered to be reliable, a weakened regulatory system cannot simply be allowed to stagger along, in defiance of the express instructions of the legislature. Public safety demands an effective regulatory mechanism to proactively examine pharmaceutical marketing, across all media, the ability to take meaningful action where transgressions are identified, and an even playing field for all actors.
*Dr Gray is a Senior Lecturer at the University of KwaZulu-Natal and Co-Director of the WHO Collaborating Centre on Pharmaceutical Policy and Evidence Based Practice. This is part of a new series of #InsideTheBox columns he is writing for Spotlight.
Disclosure: Gray is a member of South Africa’s National Essential Medicines List Committee and co-chairs its Expert Review Committee.
Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.
