By Raynold Tlhavani, Partner & Micaela Pather, Senior Associate from Webber Wentzel
The recent judgment in Moss v Road Accident Fund,1 handed down by the Western Cape High Court, has reignited debate regarding the Road Accident Fund’s (RAF’s) liability to compensate accident victims for past medical expenses already covered by their medical aid.
If this sounds familiar, that’s because it is. Recently, the same court in Rahldeyah Esack v the Road Accident Fund1 dealt with the same legal question raised in Moss: can a claimant’s right to compensation under the RAF Act 56 of 1996 be diminished by third-party payments? The court in Moss followed the earlier ruling in Esack, which held that the RAF is liable for a claimant’s past hospital and medical expenses, even if these were covered by a medical scheme.
The facts in Moss were that, in September 2017, the 77-year-old plaintiff sustained bodily injuries when he was struck by a vehicle while cycling. He claimed ZAR 34 286.59 in past medical expenses, of which ZAR 4 173.80 had been paid out of pocket, while the balance had been settled by his medical aid. The RAF opposed the claim, relying on its internal directives from 2022 and 2023, which instructed staff to reject past medical expense claims where the expenses had already been paid by a medical scheme. These directives were not formally introduced before the court. The defence was described as ill-conceived and procedurally inappropriate. Although the court declined to rule substantively on the legal issues raised by the RAF’s directives, it noted that the directive touches on complex areas of law, including common and statutory law, champerty, subrogation, and medical scheme law, which it would not address in context of this judgment.
The court also remarked on the RAF’s litigation practices, observing that the fund had drastically reduced its reliance on external counsel and instead “overburdened” a handful of attorneys at the State Attorney’s office.
It noted with concern that counsel from previously disadvantaged backgrounds, who had historically relied on RAF work, were no longer being briefed, undermining transformation imperatives. It further highlighted the impact on practitioners who, through no fault of their own, were forced to juggle multiple RAF matters in a single day.
Ultimately, the court’s decision in Moss mirrored that in Esack, granting the plaintiff a full award for past medical expenses, regardless of third-party payments. It remains to be seen whether this approach in the Western Cape Division, at odds with a Full Bench decision of the Gauteng Division, will gain traction in other divisions.
A court case over the trade names of two urinary tract infection (UTI) drugs has been settled. The court ordered that Cipla Medpro be restrained from using the trade name Furizome as it is too similar to Adcock Ingram’s UTI drug Urizone, leading to potential confusion by consumers. In his ruling, Justice James Lekhuleni of the High Court, Western Cape Division, who stated that despite safeguards against confusion in prescribing, ultimately “doctors are human”, so miscommunications could occur – and that the agency of patients cannot be ignored.
The trademark infringement case was brought by three applicants: Adcock Ingram Limited, Adcock Ingram Healthcare (Pty) LTD, and Italian company Zambon S.P.A. Zambon is the owner of the name Urizone, which is used under licence. Urizone had been launched in South Africa in 1993. The applicants stated that more than 3 million sachets had been sold between 2011 and 2023, with R5 million in advertising spent to promote the drug between 2018 and 2022 alone.
The applicants brought the case that Cipla Medpro’s Furizome, with the active ingredient fosfomycin, was too similar to their own product, Urizone, which contained the same ingredient in 3g sachets, and thus could confuse consumers. They alleged that Cipla Medpro sought to capitalise on the reputation earned by Urizone.
The applicants made the case that, despite Urizone being made available as a generic, none of the pharmaceutical companies producing it chose to use the name. When Furizome was launched, Adcock Ingram sent a letter of demand to Cipla to stop using the name due to its . Cipla, through its attorneys, rebutted the claim, saying that the two are sufficiently distinct to avoid confusion, with the “F” alluding to the fosfomycin ingredient. Cipla contended that it had already submitted the name through SAHPRA, and
Cipla also contended that the consumer – the patient – would not be misled during the prescribing and purchase of a schedule 4 medication as they would be informed by the pharmacist of the two different drugs.
In considering the judgment, the court noted that a test as to whether trademarks are be similar can be mode on a phonetic basis, or if they conceptually or visually similar. A trademark’s essential function is to indicate the origin of the goods in connection with which it is used. The “N” and “M” where seen as visually and phonetically similar, and “furi” was similar phonetically to “uri“. This could cause confusion and miscommunication even between doctors as to what drug they had prescribed a patient.
While Justice Lekhuleni acknowledged the safeguards of prescribing schedule 4 medications, he pointed out that the general public had become much more knowledgeable about prescription drugs in the past two decades. On this, he wrote “…the reality is that patients are involved in the process of deciding which medicines they will use, and that creates the risk of confusion. This situation in turn creates a responsibility upon pharmaceutical companies to make sure that they adopt trade marks that are not confusingly similar.”
The Gauteng Department of Health is appealing against a judgment by the Johannesburg High Court ordering it to provide radiation oncology treatment to a backlog of nearly 3000 cancer patients at Charlotte Maxeke Hospital and Steve Biko Hospital.
In April last year, activists from SECTION27, Cancer Alliance and the Treatment Action Campaign (TAC) joined cancer patients to march to the department’s provincial office, demanding that millions of rands set aside for radiation treatment be used.
The matter was then taken to court by the Cancer Alliance, represented by SECTION27, after years of attempts to engage with the department about radiation services. They said in a statement they wanted the court to compel the department to provide treatment to the backlog of cancer patients still waiting.
Some patients have been on the list for nearly three years, while others have died while waiting, according to the judgment by Acting Judge Stephen van Nieuwenhuizen. He noted that “irreparable harm” has occurred and continues to occur in the absence of treatment.
He said the backlog, of mostly Charlotte Maxeke patients, had grown due to a lack of radiation equipment at the hospital and a shortage of staff. This was in spite of an allocation of R784-million over three years, specifically ring-fenced for radiology oncology services. The allocation was also meant to help clear the backlog of patients.
Delays in finalising a tender for these services meant that R250-million was returned to National Treasury at the end of the fiscal year, he said.
The judge found that the provincial department had infringed on the rights of these cancer patients in that a high standard of professional ethics had not been maintained. “Efficient and effective use of resources were not promoted. Services were not provided impartially, fairly, equitably and without bias.”
Judge van Nieuwenhuizen said the provincial health department had done “nothing meaningful” since the money was allocated in March 2023 to actually provide radiation oncology treatment to the cancer patients. “On the other hand, the health and general well-being of cancer patients has significantly deteriorated. There is a clear, imminent and ongoing irreparable harm that cancer patients who are on the backlog list are suffering.”
The judge ruled that the department’s failure to provide radiation services to cancer patients on the backlog list was unconstitutional and unlawful.
He added that the provincial health officials “have conducted themselves as a law unto themselves” and ordered that measures be put in place to ensure officials are “held to account for their constitutionally imposed obligation to provide healthcare services … to cancer patients who are on the backlog list”.
He also ordered that the list of cancer patients still awaiting radiation treatment must be updated within 45 days and that a progress report and long-term plan must be submitted to the court within three months.
Salomé Meyer, director of the Cancer Alliance, told GroundUp the ruling would allow the court to get accurate information on the circumstances of each patient still waiting for treatment.
She said the judgment “confirms that civil society has a role to play to hold the government responsible for what it is supposed to do”.
In a statement on 2 April, the department confirmed that it had filed an application for leave to appeal against the ruling. The department said “there are several substantive grounds of appeal, which if left unchallenged will be greatly prejudicial to the patients undergoing radiation oncology services at the hospitals” and might set an “undesirable” precedent.
A study led by University of Oxford researchers has developed an advanced physics-based AI-driven tool to aid traumatic brain injury (TBI) investigations in forensics and law enforcement. The findings have been published in Communications Engineering.
TBI is a critical public health issue, with severe and long-term neurological consequences. In forensic investigations, determining whether an impact could have caused a reported injury is crucial for legal proceedings, yet there is currently no standardised, quantifiable approach to do this. The new study demonstrates how machine learning tools informed by mechanistic simulations could provide evidence-based injury predictions. This would help police and forensic teams accurately predict TBI outcomes based on documented assault scenarios.
The study’s AI framework, trained on real, anonymised police reports and forensic data, achieved remarkable prediction accuracy for TBI-related injuries:
94% accuracy for skull fractures
79% accuracy for loss of consciousness
79% accuracy for intracranial haemorrhage
In each case, the model showed high specificity and high sensitivity (a low rate of false positive and false negative results).
This research represents a significant step forward in forensic biomechanics. By leveraging AI and physics-based simulations, we can provide law enforcement with an unprecedented tool to assess TBIs objectively.
The framework uses a general computational mechanistic model of the head and neck, designed to simulate how different types of impacts—such as punches, slaps, or strikes against a flat surface—affect various regions. This provides a basic prediction of whether an impact is likely to cause tissue deformation or stress. However, it does not predict on its own any risk of injury. This is done by an upper AI layer which incorporates this information with any additional relevant metadata, such as the victim’s age and height, before providing a prediction for a given injury.
Lead researcher Antoine Jérusalem, Professor of Mechanical Engineering in the Department of Engineering Science, University of Oxford
The researchers trained the overall framework on 53 anonymised real police reports of assault cases. Each report included information about a range of factors which could affect the blow’s severity (e.g., age, sex, body build of the victim/offender). This resulted in a model capable of integrating mechanical biophysical data with forensic details to predict the likelihood of different injuries occurring.
When the researchers assessed which factors had the most influence on the predictive value for each type of injury, the results were remarkably consistent with medical findings. For instance, when predicting the likelihood of skull fracture, the most important factor was the highest amount of stress experienced by the scalp and skull during an impact. Similarly, the strongest predictor of loss of consciousness was the stress metrics for the brainstem.
Understanding brain injuries using innovative technology to support a police investigation, previously reliant on limited information, will greatly enhance the interpretation required from a medical perspective to support prosecutions.
Ms Sonya Baylis, Senior Manager at the National Crime Agency
The research team insists that the model is not intended to replace the involvement of human forensic and clinical experts in investigating assault cases. Rather, the intention is to provide an objective estimate of the probability that a documented assault was the true cause of a reported injury. The model could also be used as a tool to identify high-risk situations, improve risk assessments, and develop preventive strategies to reduce the occurrence and severity of head injuries.
Lead researcher Antoine Jérusalem, Professor of Mechanical Engineering in the Department of Engineering Science at the University of Oxford said: ‘Our framework will never be able to identify without doubt the culprit who caused an injury. All it can do is tell you whether the information provided to it is correlated with a certain outcome. Since the quality of the output depends on the quality of the information fed into the model, having detailed witness statements is still crucial.’
Dr Michael Jones, Researcher at Cardiff University, and Forensics Consultant, said: ‘An “Achilles heel” of forensic medicine is the assessment of whether a witnessed or inferred mechanism of injury, often the force, matches the observed injuries. With the application of machine learning, each additional case contributes to the overall understanding of the association between the mechanism of cause, primary injury, pathophysiology and outcome.’
The study ‘A mechanics-informed machine learning framework for traumatic brain injury prediction in police and forensic investigations’ has been published in Communications Engineering. It was conducted by an interdisciplinary team of engineers, forensic specialists, and medical professionals from the University of Oxford, Thames Valley Police, the National Crime Agency, Cardiff University, Lurtis Ltd., the John Radcliffe Hospital and other partner institutions.
The Hospital Association of South Africa (HASA) remains unequivocally committed to working with all stakeholders to build a healthcare system that sustainably benefits all citizens of South Africa and urges all involved parties to engage in a solution-oriented approach.
HASA believes the National Health Insurance is neither sustainable nor affordable and that dialogue and collaboration between all stakeholders is critical to finding and developing solutions to achieve universal health coverage.
HASA has thus far deferred filing a legal challenge to the NHI Act as it firmly believes that sustainable and affordable solutions, to achieve universal health coverage for all South Africans, are within reach. However, the government’s lack of response to several constructive and practical proposals, including those of Business Unity South Africa (BUSA), and the Minister of Health’s recent public statements concerning the NHI, including regarding the imminent publication of NHI regulations, have necessitated that HASA move forward with its legal challenge to the NHI legislation.
Even though HASA has decided to proceed with legal action, it remains hopeful that the Presidency will respond positively to the constructive proposals that have been made.
HASA remains open to engaging with the Government on the way forward in parallel to the legal process. Reiterating the time-critical nature of the matter, Melanie Da Costa, Chairperson of HASA, today said, “We remain firmly committed to participating constructively while the legal process unfolds. As an organisation, we have always preferred to resolve matters through dialogue, and we believe that effective healthcare solutions are urgently needed and achievable through a reasonable and collaborative approach.”
Health campaigners have slammed a decision by the Competition Commission to end its investigation into Vertex Pharmaceuticals’ monopoly on life-saving medicines for people living with cystic fibrosis.
“We are concerned that the Commission has fallen victim to Vertex’s well-known and aggressive PR and legal strategy, designed to safeguard its global patent monopoly at all costs,” said a statement by nine organisations: the South African Cystic Fibrosis Association, Right to Breathe Campaign, Health Justice Initiative, Vertex Save Us, Just Treatment, SECTION27, Treatment Action Campaign, People’s Health Movement and Cancer Alliance.
The Commission, in a statement released on 11 December, said it had initiated the probe against Vertex based on allegations that it was engaging in exclusionary practices and excessive pricing in the provision of Kalydeco, Orkambi, Symdeko and Trikafta – medicines used to treat cystic fibrosis.
“Following the Commission’s investigation and various engagements with Vertex, Vertex gave formal undertakings to the Commission to continue to make Trikafta available in South Africa through Section 21 of the Medicines and Related Substances Act, which enables the sale of unregistered drugs within South Africa,” it said.
This undertaking, it said, had resulted in a “non referral” of all allegations against the company.
It said that Trikafta had broadly replaced the use of the other medicines. Previously patients with cystic fibrosis had to import it. To reduce the financial burden, Vertex had from April this year begun supplying it through a local distributor.
“This makes Trikafta available locally at prices that enable cystic fibrosis patients to access treatment. Separately, financial assistance is available through a patient assistance programme managed by a non-government organisation, and eligible cystic fibrosis patients who belong to certain medical schemes get Trikafta at no cost as they also receive some financial assistance from their medical aid schemes.”
Unavailable
But health campaigners are not happy They say for the vast majority of cystic fibrosis patients (about 63%), nothing has changed.
“The real victims of this decision by the Commission are the most vulnerable South African children and young people who rely on the public health sector, who are not rich, and who have little or no medical scheme cover,” they said.
“These patients do not currently, and will not get access to this medication because of Vertex’s patents and secretive, limited access and excessive pricing strategies.”
Alarmingly, they said, the medicine remains unregistered in South Africa, forcing patients to either import it or rely on the “administratively burdensome” section 21 approval process.
“This is not a sustainable way to address a chronic treatment need,” they said.
The so-called patient assistance programme did not promote equity, was far from transparent, nor sustainable and the price was undisclosed.
They said they were seeking an urgent meeting with the Commission
“We cannot allow the manipulation of South Africa’s laws, regulations and health system to go unchecked in the name of one drug company’s self-interested monopoly greed.”
Vertex replies
Approached for comment, Vetex said more than 180 cystic fibrosis patients were accessing the medicine through the Section 21 pathway “which represents about 50% of the eligible population”.
“We took this pathway because we strongly believe that this is the fastest and most efficient route to sustainable access in South Africa, given that it does not require a regulatory filing, which can take many years.”
The company said even with regulatory approval, most novel, high value medicines were not included on the Prescribed Minimum Benefits list.
“There is therefore no obligation for funders [private and public health insurances] to reimburse the costs of these medicines, which effectively make them inaccessible to most patients. In our opinion, a license application would not speed up the process for broad access to our cystic fibrosis medicines.”
It said its triple combination therapy was currently funded by eleven healthcare providers, who cover most cystic fibrosis patients in the private sector in the country.
“We are continuing discussions with other health insurers and are in parallel exploring potential sustainable access opportunities in the public sector, which has been historically challenging for rare disease medicines in South Africa.”
It said “exact pricing” and details of its partnerships remained confidential.
Nomantu Nkomo-Ralehoko is the MEC for Health and Wellness in Gauteng. (Photo: GautengHealth/X)
Several opposition politicians and commentators have flagged what appears to be chronic leadership problems at the Gauteng Department of Health.
Criticism of leadership and governance at the Gauteng Department of Health (GDOH) is amping up as the department repeatedly makes headlines for questionable appointments. This unfolds alongside a damning auditor-general report, all while hospitals and clinics across the province grapple with ongoing challenges.
Arguably, the most controversial appointment is that of Arnold Malotana. He was quietly named head of department shortly after the May 29 national elections, following a year of serving in an acting capacity. Malotana has been with the department in various positions since 2008, according to his LinkedIn profile.
SIU investigation
Malotana has been implicated in a case being investigated by the Special Investigating Unit (SIU). It relates to the alleged manipulation of supply chain processes in 2016 and 2017 in favour of a company called BAS Medxpress (BAS Med). It has been alleged that Malotana and two senior officials – Edgar Motha and Sheriff Lecholo – took bribes to the tune of R8 million. The case made headlines a year and a half ago when amaBhungane lifted the lid on an affidavit from a whistleblower, who himself was part of the alleged tender-rigging scheme. The SIU investigation was however only ordered by presidential proclamation this November. According to amaBhungane’s reporting last year, all those implicated in the matter have denied wrong-doing.
SIU spokesperson Kaizer Kganyago said the probe will focus on two supply contracts – one for plastic containers and another for orthopaedic instruments – to determine if any actions broke laws, policies, or Treasury or health department rules, and whether they may be fraudulent.
“Such conduct may include manipulation of the department’s supply chain management processes by service providers, suppliers, officials, or other third parties, often in collusion with departmental employees or those in entities under its control, to secure undue benefits for themselves or others. This can result in unauthorised, irregular, or fruitless and wasteful expenditure incurred by the department, its entities or the State,” he said in a statement.
Questions over qualifications
Malotana has also been under separate investigation regarding his qualifications when his appointment as head of department was made. His LinkedIn profile lists his education as two years (2013 – 2014) at the Durban Institute of Technology and a master’s degree in public management from Regenesys Business School, with no dates provided.
Earlier this year, Jack Bloom, a DA member in the provincial legislature, wrote to the Public Protector to ask that they investigate Malotana’s appointment. Public Protector passed the matter to Parliament’s Portfolio Committee for Public Service and Administration. In turn, the committee chair requested the Public Service Commission (PSC) to investigate.
In mid-November, the PSC “reportedly” cleared Malotana on the allegations relating to his qualifications and appointment. The PSC report was leaked to The Star newspaper with the complainants – the DA – as well as the portfolio committee chairperson not yet having had sight of the report. Spotlight also hasn’t yet been able to access a copy.
According to The Star, the PSC found that a master’s degree was not explicitly listed as a required qualification, and as a result, the commission found that Malotana did meet the requirements.
Bloom told Spotlight: “It’s highly irregular that the PSC report is leaked to a specific newspaper.”
Meanwhile, the SIU investigation continues, and the DA has reiterated its call for Gauteng Premier Panyaza Lesufi to remove Malotana from his post. Heads of departments are appointed by provincial premiers.
The Office of the Premier did not answer Spotlight’s questions about Malotana or the SIU investigation. However, according to a statement from the DA, Lesufi said in a Gauteng Legislature meeting last week that he would wait for the SIU investigation to be completed before taking any action against Malotana.
Millions spent on suspended staff
In September, responses to questions posed by Bloom in the Gauteng Legislature revealed that the provincial health department spent over R13 million on salaries for nine suspended staffers in recent years. Among these were Advocate Mpelegeng Lebeloane, former chief director of legal services, who received R4.7 million while on suspension from July 2019 until 2023. He was later reinstated and then retired in July 2024.
Bloom said in a statement at the time: “Three senior staff were suspended since 26 January 2022 for alleged financial misconduct concerning the refurbishment of the Anglo Ashanti Hospital. One has recently resigned, but more than R6 million has been spent so far on their salaries in this inexcusably long-running matter.”
The other staff members had been suspended on a range of charges, including sexual assault, assault and a job-selling scam.
Bloom said the long delays in concluding disciplinary processes smacked of a failure of accountability and were a drain on taxpayers’ monies and resources.
Spotlight put questions to the health department about its mechanisms and processes to ensure efficient and appropriate disciplinary action. The department’s spokesperson Motalatale Modiba said the cases in question “cut across various departments”. He added: “The employees were suspended with full pay and the delays mainly had to do with ongoing SIU investigations.” This includes cases that were “handled through the Office of the Premier”.
Hospital CEOs
Also on Bloom’s radar are the appointments of Dr Nthabiseng Makgana, Dr Lehlohonolo Majake, and Dr Godfrey Mbara to positions of CEOs of Chris Hani Baragwanath, Steve Biko and George Mukhari academic hospitals respectively.
The appointments were made in March, and health MEC Nomantu Nkomo-Ralehoko responded to Bloom’s questions about them in October. Bloom highlighted irregularities, noting that none of the three appointees met the requirement of 8 to 10 years of experience for hospital CEO roles, while one also didn’t have the required education qualification level. These are contraventions of regulations, according to Bloom, adding that he is still to see proof of qualifications, as he’s requested.
Another high-profile appointment under scrutiny has been the redeployment of Dr Nozuko Makabayi – the former CEO of the Rahima Moosa Mother and Child Hospital. A doctor’s open letter in June 2022 exposed poor conditions at the hospital, leading to a Health Ombud investigation. The damning report criticised Makabayi for several failings, including being absent from work for nearly 100 days without explanation. The Ombud recommended that Mkabayi be removed as CEO, but she was shifted within the department to serve as acting director responsible for HIV and Aids, STIs and TB.
Bloom’s follow-up questions to Nkomo-Ralehoko brought to light that Makabayi has not been reporting for work, due to mental health stress, but continues to receive her salary. “This is outrageous. After all the trouble she caused, she is now on a long running paid holiday at taxpayers’ expense. If she can’t do any useful job, she should be medically boarded and leave the department,” he said in October.
“There has not been a permanent HR director for years in the department and the systems of appointments follow a consistent pattern of people placed in acting positions, protecting interests, and ensuring cadre deployment rather than service delivery,” Bloom told Spotlight.
“We have the wrong people in these key positions by design. We are talking about control, looting and siphoning of one of the largest budgets in the province,” he alleged.
Modiba said that “relevant bodies are investigating” and pertaining specifically to Makabayi, he said “internal processes are unfolding” but cannot be released to the media because of an “employer-employee clause”.
Scathing Auditor General report
Recently, the Gauteng Department of Health received another scathing report from the Auditor-General for the 2023/24 financial year.
The department underspent by R1.1 billion, including R590 million underspent on the National Tertiary Service Grant intended for specialised medical treatment. This in spite of backlogs and long patient waiting lists. In addition, the report showed that the health department racked up R2.7 billion in irregular spending, R17 million in wasteful spending, and lost another R2.7 billion in income.
Action SA member in the provincial legislature Emma More described the performance of the department as “clearly lacking effective leadership and management”.
She slammed the health department for providing incorrect and misleading statistics, as highlighted by the auditor-general. “For an institution like the [Gauteng] Health Department to provide such misleading information undermines public confidence in it and compromises the lives of our citizens in this province,” More said. “It is unacceptable that while our healthcare facilities are under-resourced and struggling to meet the needs of the population, significant portions of the budget are being wasted or mismanaged.”
Responding to More’s comments, Modiba said that the department had spent 98.9% of its budget allocated for 2023/2024. He said that of the 1.1% (R1.1 billion) under expenditure, R580 million has already been provisionally approved by Treasury to be carried over to the current fiscal year, subject to audited financial statements.
“While the department aims to spend every allocated cent, achieving this goal is not always feasible due to various factors impacting the operational environment. For instance, some of the money was committed to purchase orders or invoices that could not be processed within the previous financial year leading to a rollover of funds. The amount covers grants for human resource training, national tertiary services, district health programmes and the national health insurance,” Modiba said.
A ‘structural’ problem
Professor Alex van den Heever, chair of social security systems administration and management Studies at Wits University’s School of Governance, said the health department’s leadership crisis at its core is a structural one.
“South Africa has a huge pool of talent, and we are not short on good managers or people who understand health, and how to run a health service – but these are exactly the people the [Gauteng] department of health don’t want,” he said.
“Why would they want a Babita Deokaran [an acting chief financial officer who was assassinated in August 2021 after flagging what appeared to be corruption at Tembisa Hospital] or someone who is actually going to root out the nonsense or someone who is going to properly manage patient care?” Van den Heever asked.
Describing the department’s leadership as an “hourglass model”, Van den Heever said at the top are leaders with all the power, but little focus is on delivery. The pressure falls on an overstressed, underfunded middle management with limited decision-making power, which then trickles down as problems for those at the bottom.
He added: “Hospitals can’t afford this kind of leadership, they fall apart. There is no strategy behind anything, so no maintenance, proper training and supervision of staff or clinical governance. Problems aren’t solved, they’re hidden.”
Spotlight questioned the department’s alleged failure to attract “fit for purpose” candidates, resulting in more leadership and governance challenges for the department that filter down to hospital and clinic level.
In response, Modiba stated that, for the first time since 2006, they have reviewed organisational structures, which have now been submitted to the Office of the Premier.
“This is a major step towards ensuring that the Gauteng Department of Health has a structure fit for purpose that is geared to meet the service needs of the growing Gauteng population. Furthermore, a service provider has been appointed for the next three years to conduct ‘personnel suitability checks’. This will assist the department in its recruitment of suitably qualified employees who will be able to contribute meaningfully towards the achievement of the organisation’s strategic objectives,” he added.
Offering a solution to fix some of the challenges crippling the health department, Van den Heever said that changing leadership structures to orient towards service delivery could mean better governance and management, improved staff motivation, renewed public confidence and ultimately better patient care. This, he said, would require the decentralisation of powers so that competent people can take charge in hospitals, make impactful decisions about appointments and budgets, and be accountable for pockets within a complex provincial health system.
A little-noticed change to South Africa’s national health research guidelines, published in May of this year, has put the country on an ethical precipice. The newly added language appears to position the country as the first to explicitly permit the use of genome editing to create genetically modified children.
Heritable human genome editing has long been hotly contested, in large part because of its societal and eugenic implications. As experts on the global policy landscape who have observed the high stakes and ongoing controversies over this technology — one from an academic standpoint (Françoise Baylis) and one from public interest advocacy (Katie Hasson) — we find it surprising that South Africa plans to facilitate this type of research.
The fate of these three children, and whether they have experienced any negative long-term consequences from the embryonic genome editing, remains a closely guarded secret.
Controversial research
Considerable criticism followed the original birth announcement. Some argued that genetically modifying embryos to alter the traits of future children and generations should never be done.
Many pointed out that the rationale in this case was medically unconvincing – and indeed that safe reproductive procedures to avoid transmitting genetic diseases are already in widespread use, belying the justification typically given for heritable human genome editing. Others condemned his secretive approach, as well as the absence of any robust public consultation, considered a prerequisite for embarking on such a socially consequential path.
In the immediate aftermath of the 2018 revelation, the organizing committee of the Second International Summit on Human Genome Editing joined the global uproar with a statement condemning this research.
At the same time, however, the committee called for a “responsible translational pathway” toward clinical research. Safety thresholds and “additional criteria” would have to be met, including: “independent oversight, a compelling medical need, an absence of reasonable alternatives, a plan for long-term follow-up, and attention to societal effects.”
Notably, the additional criteria no longer included the earlier standard of “broad societal consensus.” https://www.youtube.com/embed/XAhFoaT6Kik?wmode=transparent&start=0 Nobel laureate David Baltimore, chair of the organizing committee for the Second International Summit on Human Genome Editing, talks about the importance of public global dialogue on gene editing.
New criteria
Now, it appears that South Africa has amended its Ethics in Health Research Guidelines to explicitly envisage research that would result in the birth of gene-edited babies.
Section 4.3.2 of the guidelines on “Heritable Human Genome Editing” includes a few brief and rather vague paragraphs enumerating the following criteria: (a) scientific and medical justification; (b) transparency and informed consent; (c) stringent ethical oversight; (d) ongoing ethical evaluation and adaptation; (e) safety and efficacy; (f) long-term monitoring; and (g) legal compliance.
While these criteria seem to be in line with those laid out in the 2018 summit statement, they are far less stringent than the frameworks put forth in subsequent reports. This includes, for example, the World Health Organization’s report Human Genome Editing: Framework for Governance (co-authored by Françoise Baylis).
Alignment with the law
Further, there is a significant problem with the seemingly permissive stance on heritable human genome editing entrenched in these research guidelines. The guidelines clearly require the research to comply with all laws governing heritable human genome research. Yet, the law and the research guidelines in South Africa are not aligned, which entails a significant inhibition on any possible research.
This is because of a stipulation in section 57(1) of the South African National Health Act 2004 on the “Prohibition of reproductive cloning of human beings.” This stipulates that a “person may not manipulate any genetic material, including genetic material of human gametes, zygotes, or embryos… for the purpose of the reproductive cloning of a human being.”
When this act came into force in 2004, it was not yet possible to genetically modify human embryos and so it’s not surprising there’s no specific reference to this technology. Yet the statutory language is clearly wide enough to encompass it. The objection to the manipulation of human genetic material is therefore clear, and imports a prohibition on heritable human genome editing.
Ethical concerns
Photo by Tingey Injury Law Firm on Unsplash
The question that concerns us is: why are South Africa’s ethical guidelines on research apparently pushing the envelope with heritable human genome editing?
In 2020, we published alongside our colleagues a global review of policies on research involving heritable human genome editing. At the time, we identified policy documents — legislation, regulations, guidelines, codes and international treaties — prohibiting heritable genome editing in more than 70 countries. We found no policy documents that explicitly permitted heritable human genome editing.
It’s easy to understand why some of South Africa’s ethicists might be disposed to clear the way for somatic human genome editing research. Recently, an effective treatment for sickle cell disease has been developed using genome editing technology. Many children die of this disease before the age of five and somatic genome editing — which does not involve the genetic modification of embryos — promises a cure.
Implications on future research
But that’s not what this is about. So, what is the interest in forging a path for research on heritable human genome editing, which involves the genetic modification of embryos and has implications for subsequent generations? And why the seemingly quiet modification of the guidelines?
How many people in South Africa are aware that they’ve just become the only country in the world with research guidelines that envisage accommodating a highly contested technology? Has careful attention been given to the myriad potential harms associated with this use of CRISPR technology, including harms to women, prospective parents, children, society and the gene pool?
Is it plausible that scientists from other countries, who are interested in this area of research, are patiently waiting in the wings to see whether the law in South Africa prohibiting the manipulation of human genetic material will be an insufficient impediment to creating genetically modified children? Should the research guidelines be amended to accord with the 2004 statutory prohibition?
Or if, instead, the law is brought into line with the guidelines, would the result be a wave of scientific tourism with labs moving to South Africa to take advantage of permissive research guidelines and laws?
We hope the questions we ask are alarmist, as now is the time to ask and answer these questions.
Katie Hasson, Associate Director at the Center for Genetics and Society, co-authored this article.
South Africa’s medical schemes industry is taking a strong, zero-tolerance stance against fraud, waste, and abuse – practices that are undermining the healthcare system. Fraudulent claims, unnecessary procedures, and mismanagement of resources are costing billions of rand, inflating healthcare costs, and putting additional financial strain on members. Instead of supporting essential treatments and care, these resources are being misused and misallocated, writes Dr Katlego Mothudi, Managing Director at the Board of Healthcare Funders (BHF).
At the recent BHF Healthcare Collab Hub, industry leaders highlighted the need for immediate reforms to curb these harmful practices and safeguard the future of medical schemes. As healthcare costs continue to rise, tackling fraud (deliberate deception), waste (inefficient use of resources), and abuse (excessive or improper use of services) is essential for ensuring that medical schemes remain affordable and sustainable. Without swift action, members may face higher premiums, with fewer resources available for the critical care they depend on.
Fraud, waste, and abuse (FWA) in the healthcare sector is not just a regulatory issue or an administrative headache, but a direct assault on the wellbeing of medical scheme members. Every fraudulent claim, and every misuse of resources, drains the pool of funds that are meant to ensure that individuals have access to necessary healthcare services. For millions of members, the repercussions of unchecked FWA include increased premiums, reduced benefits, and the potential for schemes to become financially unsustainable. It is a burden borne by all members, regardless of whether they have directly engaged with healthcare services or not.
The healthcare industry, specifically medical schemes and their administrators, has a significant responsibility to address this problem head-on. Their duty extends beyond managing funds – they are custodians of a system designed to protect individuals’ access to essential healthcare services.
If these schemes fail to adequately combat FWA, the entire medical scheme ecosystem becomes compromised, undermining trust in healthcare funding and leaving members exposed to higher costs and decreased quality of care.
The ripple effect of FWA
The scale of FWA in the medical schemes sector is staggering. According to industry reports, billions of rands are lost annually to fraudulent activities. Whether through inflated billing, unnecessary procedures, or outright false claims, these actions take funds directly from the pockets of members. Medical schemes are forced to increase premiums to cover these losses, meaning that honest, hardworking individuals are paying more for their healthcare – not because of rising medical costs, but because of the unethical behaviour of a few.
Moreover, the administrative costs associated with managing and investigating FWA claims are significant. These costs divert funds that could otherwise be used to enhance member benefits or improve healthcare services.
The long-term impact is even more worrying. If left unchecked, FWA can destabilise the entire medical scheme system. Ultimately, it is the members who suffer the most, facing financial uncertainty and diminished healthcare support when they need it most.
What the industry can do: Curbing FWA
The healthcare industry has both the tools and the responsibility to take decisive action against FWA. Key stakeholders, including medical schemes, administrators, and regulatory bodies, must collaborate to develop comprehensive strategies that can curtail the losses associated with these unethical practices. Here are some key strategies:
1. Enhanced use of technology and data analytics
The industry is already moving towards the use of automated systems and data analytics to detect unusual patterns and potential fraud. However, the systems need continuous improvement to keep up with the evolving tactics of fraudsters. Schemes should invest in advanced algorithms and artificial intelligence (AI) tools that can analyse claims in real-time, flagging high-risk transactions before they are paid. Machine learning models, for instance, could identify patterns that suggest fraudulent behaviour, such as repeated claims for the same procedure or suspiciously high billing from certain providers.
This not only helps in early detection but also ensures that members who follow the rules aren’t unfairly penalised. It is essential, however, that these systems remain transparent to avoid unintended biases or discriminatory practices.
2. Collaboration across the healthcare ecosystem
The fight against FWA cannot be won by medical schemes alone. There needs to be greater collaboration between schemes, healthcare providers, and regulatory bodies. Sharing data across schemes and industries can help to identify serial offenders who hop between schemes, committing fraud on a wide scale.
Additionally, healthcare providers themselves play a critical role. They should be incentivised to report fraudulent activities or billing irregularities they observe within their network. Schemes can establish anonymous reporting systems and offer rewards for whistleblowers who help to uncover fraud. By creating a network of accountability, the industry can make it more difficult for fraudsters to operate with impunity.
3. Member education and engagement
Members are the first line of defence against fraud. If they are empowered with the right information, they can help to identify fraudulent or abusive practices. Medical schemes should launch educational campaigns that inform members about how to scrutinise their healthcare bills and understand their benefits better.
Simple actions such as checking that all billed procedures were performed or verifying service dates can catch many fraudulent claims early. Members who understand the importance of vigilance are less likely to be unwittingly complicit in fraud and can help schemes prevent abuse of the system.
4. Improved consequent management
Strong consequent management is one sure way of deterring this fraudulent behaviour. The Health Professions Council should impose appropriate penalties on healthcare professionals found guilty. Schemes should not hesitate to take legal action against individuals or providers who commit fraud.
Stronger penalties, including prison sentences and significant fines, can serve as a deterrent.
Moreover, schemes must ensure that once a provider or member has been found guilty of fraud, they are blacklisted across all schemes. Allowing repeat offenders to continue exploiting the system is a failure that impacts all members.
At the heart of any medical scheme is the promise to its members that they will be provided with financial protection when they need healthcare. Fraud, waste, and abuse erode this promise, making it harder for schemes to deliver on their commitments. To safeguard the integrity of the system and ensure that members receive the care they deserve, the healthcare industry must step up its efforts to curb these damaging practices.
By embracing technology, fostering collaboration, educating members, and enforcing strict penalties, the industry can make significant strides in reducing FWA. In doing so, they will not only protect their financial stability but also uphold the trust and confidence that members place in them. This, above all, is the most important goal.
An investigation by Science has shown that over 100 key papers on Alzheimer’s research have used falsified data. The papers all have a common author – veteran neuropathologist Eliezer Masliah, a key researcher at the National Institute on Aging (NIA), typically as first or last author.
The investigationhas found that scores of Masliah’s lab studies at the University of California San Diego (UCSD) and NIA are riddled with apparently falsified Western blots (images used to show the presence of proteins) and micrographs of brain tissue. Numerous images seem to have been inappropriately reused within and across papers, sometimes published years apart in different journals, under supposedly different experimental conditions.
At UCSD, Masliah had amassed decades of experience researching Alzheimer’s and Parkinson’s disease, amassing 800 papers. Some important topics in them, such as alpha-synuclein (a protein linked to both diseases), continue to have great influence. The US Congress had released a flood of funding for Alzheimer’s research, US$2.6 billion for last year’s budget, far outstripping that for the rest of the NIA, and Masliah was an ideal choice for its neuroscience division director. This was a position which was enormously influential for Alzheimer’s research in the US as well as internationally, allowing him to fund selected research over and above others with better scores form peer-review.
One of the drugs being developed based on his work is prasinezumab, which failed to show benefit over placebo in a trial of 316 Parkinson’s patients – but resulting in a host of adverse effects, though none serious. The drug was based on an idea by Masliah and another scientist (whose papers were also seemingly doctored) that a vaccine-like approach could cause the body to create antibodies against harmful precursors in both Parkinson’s and Alzheimer’s.
Questions began to be raised about his research two years ago. These were assessed by a team of forensic analysts and a neuroscientist, who concluded, “In our opinion, this pattern of anomalous data raises a credible concern for research misconduct and calls into question a remarkably large body of scientific work.” They acknowledge that accidental duplication is a possibility, and that images can acquire artefacts resembling improper manipulation during the publication process.
Columbia University neurobiologist Mu Yang used specialised software to detect similarities and alterations in images. She had previously worked with the team investigating manipulation in Alzheimer’s and stroke data. In her analysis, duplicated sections in certain Western blots that had been “seamlessly blended” quickly floated into view, she said. “It tells me someone put a lot of thought and effort into the image … and usually indicates something is very wrong.”
A team of 11 neuroscientists was less charitable when they viewed the images. Samuel Gandy, a prominent neurologist at the Mount Sinai Alzheimer’s Disease Research Center said that he was “floored” by what he saw, noting that even a “bus driver” could see that two images of a mitochondrion published two years apart were identical. “Hundreds of images,” he said in a video interview. “There had to have been ongoing manipulation for years.”
In response to this latest dossier, the NIH issued a statement stating that there was a finding of “research misconduct” for Masliah over reuse of figures in two papers, further stating that Masliah no longer serves as NIA’s neuroscience division director. The NIH stated that it had started its own investigation in 2023.
