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.”
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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.
Payments of medical related legal claims (medico-legal) against the Department of Health ballooned to R2.7-billion in 2023. In 2013, it was R265-million. This is according to the Special Investigating Unit (SIU) when it briefed the Standing Committee on Public Accounts (SCOPA) last week.
SIU head advocate Andy Mothibi told SCOPA it found evidence of collusion between attorneys, touts, nurses and doctors, in both public and private healthcare. Some law firms also withdrew claims when the SIU started investigating them. This had stopped about R3-billion in fraudulent claims, he said.
Claims under investigation included those targeting families with children born with cerebral palsy, false claims of medical malpractice in state hospitals, and collusion between state healthcare workers and rogue lawyers to unlawfully secure private medical records to initiate claims against the government.
They uncovered cases of agents of rogue law firms impersonating officials of the South African Social Security Agency to secure powers of attorney on behalf of victims by claiming to be securing them social grants. He said they found two attorneys pursuing identical claims for the same individual in two different courts, and for vastly different amounts, in one case for R7.5-million and R25-million for the same patient and same condition
Mothibi said the health sector experienced an explosion of medical practice litigation cases in 2015, directed against health institutions and individual medical practitioners in both public and private practice.
Mothibi said in one case a claimant demanded R70-million for a supposedly botched circumcision at a Limpopo hospital when no circumcision had been performed.
In 2017, the SIU started targeting provinces with the highest share of claims. At that stage, the Eastern Cape’s contingent liability for medico-legal claims was R15.9-billion; in Gauteng, it was R21.2-billion.
In the Eastern Cape, most medico-legal claims emanated from one Johannesburg-based law firm, Nonxuba Attorneys Incorporated. In five years, from 2012 to 2017, the firm submitted 44 claims totaling R497-million against the provincial health department. Nine claims for children born with cerebral palsy were identical each demanding R15-million.
“This was suspicious and indicated a lot of cut-and-paste on the part of this legal firm,” said Mothibi.
The company has, according to Mothibi’s presentation, been charged.
We have been unable to get hold of Nonxuba Attorneys and Business Day has previously reported that the company’s owner, Zuko Nonxuba, has been suspended from legal practice.
Also, in the Mthatha High Court claims increased from 46 to 529 between 2010 and 2016. There was collusion, said Mothibi, between some officials in the Office of the State Attorney, whereby out-of-court settlements for hefty sums were entered into without the mandate or even the knowledge of the department.
MP Veronica Mente-Nkuna (EFF) wanted to know the names of the legal firms implicated besides Nonxuba Attorneys and what the legal bodies have done about their operating licences.
She asked why the Department of Health had not conducted its investigations before the claims were paid. Who was responsible for the loss of money through these fraudulent claims, she asked.
Cheri Nel launched a court case against Vertex to force them to allow their generic cystic fibrosis drug to be imported into South Africa. Credit: Spotlight
By Catherine Tomlinson
Last year a South African woman took a multibillion-dollar United States pharmaceutical company to court with the aim of securing access to life-changing cystic fibrosis medicines. That case has now been dropped following a reduction in the price charged for the medicines in South Africa.
Cheri Nel, a Johannesburg-based investment banker, has dropped a potentially landmark court case against Vertex Pharmaceuticals. Nel was asking the Gauteng Division of the High Court in Pretoria to grant a compulsory licence to allow generic versions of a cystic fibrosis medicine called Trikafta to be imported into South Africa. No such compulsory licences on medicines have ever been granted in South Africa.
Trikafta, which was registered in the United States in 2019, has been hailed as a “miracle” treatment for cystic fibrosis, which causes severe damage to the lungs, digestive system and other organs in the body. The medicine is effective in treating around 90 percent of people living with the condition. It significantly improves the quality of life of people living with cystic fibrosis, eliminating many of its debilitating symptoms, while also slowing the disease’s progression and extending survival.
In February 2023, when Nel launched her lawsuit against the Boston-headquartered pharmaceutical company, the only way people in South Africa could access Trikafta was by travelling to Argentina to buy it from an Argentinian company selling a generic version of the medicine.
This is because Vertex, the company that holds the patents on Trikafta in South Africa, refused to register the medicine with the South African Health Products Regulatory Authority (SAHPRA) or identify a local distributor that could import unregistered Trikafta via Section 21 authorisations – a mechanism allowing importation of unregistered medicines.
The United States list price for Trikafta is currently over $300 000 (around R5.5 million at the current rand/dollar exchange rate) per person per year, which South Africans feared they would also have to pay if or when Vertex finally started supplying its medicine in the country. Researchers in the United Kingdom have estimated that Trikafta can be produced for under $6000 (around R110 000 at the current rand/dollar exchange rate) per person per year.
When Nel filed the case, generic Trikafta from Argentina – called Trixacar – was much cheaper than Vertex’s product (but still prohibitively expensive for many) at around $60 000, or almost R1 million per person per year. But the Argentinian company selling generic Trixacar faced potential patent infringement challenges if it shipped Trixacar to South Africa. Thus, the only way to get the medicine into South Africa at the time was to travel to Argentina to collect it. People living with cystic fibrosis in South Africa learnt how to do this through an informal network or Buyers Club of people around the world that were reliant on the Argentinian product.
Launching a legal case
Nel argued that Vertex was abusing its patents in South Africa by refusing to make Trikafta available in the country on reasonable terms, while also blocking other manufacturers from supplying the medicine in the country. If successful, Nel’s case would have allowed generic Trikafta to be shipped directly to South Africa, removing the need for travel to Argentina to access the medicine.
According to Nel, Vertex argued in the company’s answering documents to her legal filing that, as she was the only named applicant in the case, a compulsory licence for importation could only be considered for her.
Nel then worked with the South African Cystic Fibrosis Association (SACFA) to get other people living with cystic fibrosis admitted as co-applicants in the case. This process of seeking more people to join her case, she said, was time-consuming, difficult, and expensive, but more than 100 people were working towards being admitted as co-applicants before the case was dropped.
Under pressure, Vertex starts providing Trikafta in South Africa
As the case gained momentum and made headlines around the world, Vertex finally opened the door to allow some people living in South Africa to access their product.
In May 2024, Vertex identified Equity Pharmaceuticals as the local company through which Trikafta could be imported into South Africa via Section 21 authorisations. These authorisations are granted by SAHPRA to enable importation of an unregistered medicine and are meant to be used in exceptional circumstances to remedy the need for an unregistered medicine, such as when there is a shortage of the registered product.
While Vertex has not confirmed to Spotlight or stated publicly the price of Trikafta for people living in South Africa, Nel and Doctors Without Borders’ Candice Sehoma told us that the company is charging around R400 000 ($22 000) for a year’s supply of the medicine.
While still unaffordable for many and much higher than the estimated cost of manufacturing, the R400 000 price is drastically lower than the R5.5 million price charged in the United States and originally feared for South Africa.
It seems improbable that Vertex would have offered the much reduced price to people living in South Africa had Nel not launched the court case
Some medical schemes now paying for Trikafta
As emerged in April this year, Vertex reached an agreement with some medical schemes in South Africa to provide the medicine for people on top-end plans.
“Four private healthcare providers are currently funding Trikafta for eligible patients and we are open for conversations with more insurance companies,” Vertex’s spokesperson Daria Munsel confirmed to Spotlight.
The exact nature of the conversations and/or agreements between Vertex and medical schemes in South Africa however remains somewhat unclear.
Discovery Health‘s CEO, Dr Ron Whelan, told Spotlight it has engaged Vertex about the “benefits available” and “affordable access” of the class of medications that Trikafta falls in but there is “no specific commercial agreement in place” in South Africa.
He noted that Discovery Health Medical Scheme members on the comprehensive and executive plans have a suite of benefits available for the treatment of cystic fibrosis with medicines like Trikafta “of up to R400 000 per annum” for eligible people.
According to Vertex, uptake of its product has been swift and is already starting to make a difference in the lives of people living with cystic fibrosis in South Africa. “Over 100 South Africans with CF [cystic fibrosis] have been prescribed our triple combination treatment in just the first two months of the medicine being available,” said Munsel.
The cystic fibrosis registry, an initiative which seeks to identify and collect data on the outcomes of people living with cystic fibrosis in South Africa, identified 525 people living with cystic fibrosis in the country as of December 2020. Experts believe there are many more undiagnosed cases.
Why did Nel drop the case?
Not only is Vertex’s price for people in South Africa now lower than the 2023 price of Argentinian generics, but the cost of a year’s supply of generic Trikafta from Argentina have increased from around $60 000 to around $100 000 due to hyperinflation in that country.
With Vertex now offering a price lower than the cost of Argentinian generics, Nel decided that her legal case was no longer the best avenue to enhance access to the medicine. The aim of the case “was to get access to the medication… to put pills in patients’ mouths”, she told Spotlight.
Nel said it is now probably better to redirect efforts to getting government at national or provincial levels to buy the medicine for patients in the public sector.
“There is a lot of work still to be done… my efforts are still there, it’s just being redirected,” she said.
“The fact that Trikafta will now be available in South Africa at a much lower price compared to generic versions globally, certainly undercuts the legal case for a compulsory license,” said Tendai Mafuma of SECTION27, a public interest law centre. The Treatment Action Campaign and Doctors Without Borders, represented by SECTION27, were admitted as friends of the court in the case.
Why won’t Vertex register its product in SA?
While much has changed because of Nel’s legal action, Vertex has held fast on its refusal to register Trikafta with SAHPRA.
When asked about Vertex’s plans to register Trikafta in South Africa, Munsel said: “We strongly believe that this [Section 21 Authorisation] is the fastest and most efficient route to sustainable access in South Africa, which does not require a regulatory filing.”
While registering medicines can be onerous and time consuming, it is a routine practice required for pharmaceutical companies to operate around the world. Full registration also typically requires that safety, effectiveness and quality is more closely scrutinised than is the case with Section 21 authorisations.
Nel believes that Vertex has chosen not to register Trikafta in South Africa because of the price transparency requirements embedded in South African law. If other countries know what price South Africa is paying then they may also demand a lower price, she said.
The law requires that there is a transparent pricing system for medicines sold in the private sector, but these requirements do not extend to unregistered medicines imported through Section 21 authorisations, explained Mafuma.
Note: SECTION27 was involved in the court case that is the subject of this article. Spotlight is published by SECTION27, but is editorially independent – and independence that the editors guard jealously. Spotlight is a member of the South African Press Council.
Pro Secure fails in bid to stop Special Investigating Unit going after it to recover millions of rands
Photo by J Castellon on Unsplash
A company accused of unlawfully benefiting from a multi-million rand contract to supply personal protective equipment (PPE) during the Covid pandemic, has failed in a bid to quash a summons issued against it by the Special Investigating Unit to recover the money.
Pro Secure raised several objections to the formulation of the case against it in the papers. But Special Tribunal Judge Kate Pillay has dismissed the company’s objections and ordered the company to pay the costs.
The SIU investigation uncovered irregularities in the Limpopo Department of Health’s appointment of service providers including Pro Secure, Clinipro and Ndia Business Trading, which resulted in about R182-million irregular and wasteful expenditure. The SIU initiated action against Pro Secure, alleging the company had made “secret profits”, and also instituted civil proceedings against the former head of health in the province, Dr Thokozani Florence Mhlongo.
In October 2022, the SIU secured an order from the Special Tribunal, effectively freezing Mhlongo’s pension fund until the outcome of the civil action against her. Mhlongo resigned in June that year while facing disciplinary charges.
In its application to the Tribunal, Pro Secure challenged the SIU’s legal standing, the fact that the Limpopo health department was not a party to the SIU action. Pro Secure also claimed that there was no allegation that its bid for the contract was not lawful.
Judge Pillay found there was no substance to any of the company’s arguments.
She said the particulars of claim in the civil action set out how Pro Secure had received a payment “significantly exceeding their initial bid”.
She said that according to the SIU, the request for quotation sent by the department was for 5000 automated hand sanitisers. Pro Secure had submitted a quote for 5000 white electronic hand disinfectant dispensers and for 5000 liquid sanitisers, the total amount being just over R7-million. Ultimately, the company had delivered 30 000 dispenser holders at R420 per unit and 900 000 litres of hand sanitiser at R170 a litre and had been paid almost R162-million.
In a statement, SIU spokesperson Kaizer Kganyago said: “This ruling supports the SIU’s stance on the irregular procurement of PPE by the Limpopo Department of Health during the pandemic.”
iTOO Special Risks, a specialty risk underwriter and EthiQal, a medical professional indemnity provider for specialist doctors, have announced an exciting strategic partnership. This collaboration, backed by Hollard, one of South Africa’s largest non-life insurers, aims to bolster EthiQal’s mission to protect healthcare professionals with robust, reliable coverage and medico-legal support.
Together, the partnership reinforces the comprehensive suite of medical malpractice insurance cover available across the spectrum; iTOO’s focus on allied professionals, General Practitioners, institutions and clinical trials continues and EthiQal remains focussed on specialist practitioners.
Together this partnership unlocks valuable opportunities to achieve the shared vision of strengthening the protection of the medical profession, without which the delivery of high quality healthcare is not achievable.
EthiQal Reinforced
EthiQal’s dedication to safeguarding specialist practitioners aligns perfectly with iTOO’s extensive network and expertise in specialty insurance. This partnership, ‘EthiQal Reinforced,’ aims to leverage the strengths of both entities to enhance their offerings and deliver world-class products and services to their clients.
“We are saying this partnership is ‘EthiQal Reinforced’ because while EthiQal is already a strong entity, together with iTOO, it becomes even bigger and stronger,” says Justin Naylor, CEO at iTOO. “iTOO’s extensive network and resources bring additional and complementary skills and capabilities to support EthiQal and its customers.”
Naylor further elaborates, “We have a 20-year track record and well-established risk underwriting capability with a market-leading diverse product range, backed by a complete cradle-to-grave infrastructure. This partnership combines the expertise and track records of both iTOO and EthiQal, reinforcing their excellent offerings.”
EthiQal’s Vision and Strengths
Alex Brownlee, CEO of EthiQal, highlights the alignment of principles and vision that initially brought the two parties together. “iTOO brings a legacy of deep insurance expertise, an extensive network, and additional skills that complement our own. This partnership provides enhanced financial backing, stability, and reliability,” says Brownlee.
Brownlee emphasises the focused and niche market that EthiQal serves, which requires leading risk management support. “Medical malpractice, particularly in fields like obstetrics, spinal surgery, neonates and neurosurgery, involves high risks and long-duration claims. This has driven us to develop deep expertise and understanding of the medico-legal landscape,” he notes.
EthiQal’s team includes a dedicated clinical team, an in-house legal team available for urgent advice and legal support, and personalised quality service. Brownlee assures that the partnership will not change the way EthiQal does business, nor change its products or services, but will reinforce and support the dedicated and steadfast EthiQal team in their commitment to support doctors.
Financial Resilience and Support
EthiQal has strong financial capacity, with a Solvency Capital Requirement above 120%, well beyond the regulatory 1-in-200-year event solvency requirement. The firm enjoys continued financial backing from Dr. Christo Wiese’s Titan Group and reinsurance cover from Lloyd’s of London. Along with iTOO and Hollard, this combination offers improved financial support, stability, and reliability “for our clients’ benefit”, Brownlee stresses.
“EthiQal offers incredible value for medical specialists, and Titan will continue to invest significant resources to build EthiQal’s capacity to measure, mitigate and absorb medical malpractice risk. Alex Brownlee and the team’s drive and capability is what attracted us to the business and what will ensure EthiQal continues to offer value to its policyholders and broker partners”, says Titan’s investment executive Zac Pitsillis.
Engagement and Education
Brownlee also confirmed that EthiQal will remain actively involved in the medical community through conferences, presentations, and educational grants. “Over the last 2 years in particular we have been extremely active in sharing our knowledge and insights, aiming to support doctors and their medical societies.”
Commitment to Quality and Service
“This partnership with iTOO, backed by Hollard, reinforces the quality and value of EthiQal’s products and people, demonstrating confidence in EthiQal’s future and the team that makes it happen,” Brownlee concludes. “The alignment in our values, vision and approach to clients is a critical reason why this partnership is ideal.”
A key part of the National Health Insurance Act is the requirement of private healthcare facilities to obtain a Certificate of Need (CON) in order to practise. Now it, this component has been struck down by a Pretoria High Court judge. Judge Anthony Millar struck down the Act’s key section, saying that it was “akin to an attempt to indenture the private medical service in the service of the state”.
The case had been brought by the Solidarity Trade Union, the Alliance of South African Practitioner Associations, the South African Private Practitioner Forum, the Hospitals Association of South Africa (HASA) and a number of healthcare providers and owners of healthcare establishments.
Sections 36 to 40 of the NHI Act would introduce a Certificate of Need (CON) scheme, essentially tying down doctors to a specified geographical location, which would be the only location where they could render their services.
It is declared that sections 36 to 40 of the National Health Insurance Act 61 of 2003 are invalid in their entirety and are consequently severed from the Act.
Judge Anthony Millar’s ruling
Any new healthcare facility would have to apply for a CON, which would be valid for 20 years. Existing facilities would have two years’ grace period to apply. This would applicable to hospitals, clinics, pharmacies and even to private rooms set up within the home of the practitioner. Operating without one would be a criminal offence – punishable with a fine, five years in prison or both.
It had been argued that because the regulations for CON had not been promulgated, the applicants’ argument was “hypothetical” and not “crystallized”. In Tuesday’s ruling, Judge Millar cited previous rulings and the constitutionality of the matter was still worth testing.
The CON scheme was extensive, Judge Millar noted, and would impact not only healthcare practitioners who worked in healthcare facilities and their employees, but also “juristic persons“, ie corporations or other organisations that can be legally liable.
In terms of its constitutionality, the applicants’ argument was that, “at least six constitutional rights are infringed. They say it tramples on their rights including where they want to reside, send their children to school and the communities they belong to.”
Judge Millar noted, would mean that setting up a hospital was a hefty investment of R500 million or so, and there was no provision any support. Taken together with the 20-year CON validity, would serve to discourage private investment and became a “blunt instrument” with which the Director-General of Health could control private healthcare in the country.
Even though this provision was ostensibly to serve many, this could not come at the cost of individual freedoms, among them Section 22 of the Constitution which provided for the freedom to choose an occupation within the rule of law.
“The scheme is silent on the extant rights of both the owners of private health establishments, private healthcare service providers and private healthcare workers. Such extant right include their integration and professional reputations in the communities which they presently serve together with the significant financial investments and commitments made by them to be able to render the services that they do.”
Since health establishments are purpose-built and hard to convert for other use, this constitutes a de facto deprivation, he wrote.
“It does not behove government in pursuing transformation, to trample upon the rights of some ostensibly for the benefit of the many.”
‘Effective indenture’ of private healthcare
While the legal teams for President Cyril Ramaphosa, the minister of health, Dr Aaron Motsoaledi, and the director-general of health, Dr Sandile Buthelezi, argued that the public healthcare sector was overburdened, Judge Millar replied that this amounted to the effective indenture of the private healthcare system.
Among other problems, contesting CON issuance was without recourse and by turning down a certificate the DG could essentially deprive the affected parties of income, as doing so would see them prosecuted under Section 40.
The ruling was welcomed by healthcare professional associations.
As reported in the Daily Maverick, Solidarity chief executive Dr Dirk Hermann said, “This judgment is a major blow to the total NHI [National Health Insurance] idea, as the principle of central management is a core pillar of the NHI Act itself. A more extensive consequence of this ruling with regard to the certificate of need is that parts of the NHI Act are now probably also illegal in principle.
“The NHI in its current format cannot be implemented as the essence of the NHI is central planning – and this has now been found unconstitutional.”
In a statement, HASA said that it regretted that the matter had to come to court. “We would have preferred achieving the objective of a stronger health system through a negotiated and collaborative effort to increase the number of medical students and nurses in medical training facilities to address the healthcare system’s needs,” the association stated.
