Category: Ethics and Law

Join EthiQal for an Ethics Webinar: HPCSA Booklet #9: Ethical Record Keeping in the Digital Age

Ethical patient record keeping is essential to modern healthcare, ensuring safe, effective, and trustworthy care. Accurate documentation supports continuity, clinical decision-making, and legal accountability, while also carrying ethical importance by safeguarding sensitive information with honesty, confidentiality, and respect. Poor record keeping can decrease patient outcomes, create confusion, impact multidisciplinary collaboration, and create legal risk.

Managing records ethically protects patient privacy and autonomy while allowing patients access and control over their health data. With the growth of digital health technologies, new challenges such as data security, electronic informed consent, and cybersecurity have emerged. Breaches or cyberattacks can erode trust, discourage information sharing, and disrupt care delivery, highlighting the need to balance accessibility with strong safeguards.

 Join our expert speaker panel to explore how you can effectively manage your patient records to ensure integrity and continue to build trust vital to patient-centred healthcare. 

During this webinar, attendees will review the HPCSA Booklet 9: Guidelines on the keeping of patient health records where the pertinent South Africa laws and basic principles around ethical practices for maintaining patient health records are laid out. The webinar will offer insights into both paper and electronic record-based practices.

The audience will have an opportunity to engage with faculty who offer insights from a clinical, legal, medical malpractice insurance, cybersecurity, and medical practice setup and management perspective through short lectures, interactive case studies, a series of multiple choices questions and Q&A sessions.

This webinar will focus on specialist practices. Administrative staff working in these practices are welcome to join the discussion.

Seats are limited.

Click here to sign up for the webinar.

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

Photo by Bill Oxford on Unsplash

By Ufrieda Ho

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

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

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

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

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

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

The court instructed the department to:

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

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

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

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

The waiting list

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

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

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

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

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

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

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

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

Calls for accountability

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

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

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

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

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

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

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

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

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

Republished from Spotlight under a Creative Commons licence.

Read the original article.

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

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

By Andy Gray

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

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

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

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

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

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

‘Failure to follow through’

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

Photo by Derek Finch

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

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

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

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

Industry self-regulation

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

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

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

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

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

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

Republished from Spotlight under a Creative Commons license.

Read the original article.

Carte Blanche “Gagging” Order Overturned

Photo by Bill Oxford on Unsplash

A “gagging order” preventing Carte Blanche from broadcasting a programme about a Durban-based cardiologist accused of malpractice has been set aside.

Pietermaritzburg High Court Judge Siphokazi Jikela has ruled that the finalisation of the interdict, granted in early June by another judge, would “amount to an unjustified prior restraint and would undermine the essential role of the media in a democratic society”.

The matter came before Judge Jikela for determination on whether or not the interim order should be made final.

She has now dismissed the application and ordered cardiologist Dr Ntando Peaceman Duze to pay the costs.

Duze was accused by some of his patients of inserting stents unnecessarily, which resulted in them lodging complaints with the Health Professions Council of South Africa (HPCSA).

Carte Blanche interviewed them and got independent experts to corroborate their claims.

While Carte Blanche gave him multiple opportunities over two weeks to respond to questions, Duze turned to the courts, claiming “defamation” and preventing the airing of the segment. He wanted the interdict to be made final until the HPCSA had ruled on the complaints against him.

The matter was argued before Judge Jikela the following week. She handed down her ruling on Monday.

Read the judgment

Read GroundUp editorial: Judges should respect press freedom

Duze, in his initial application, also cited two other cardiologists as respondents but did not persist with his claims against them.

However, he said the complaints against him were instigated by them because of “professional jealousy”, a “conspiracy” and a “smear campaign”, because of the success of his practice at Westville Life Hospital.

He said he had elected not to respond to Carte Blanche because the questions were “defamatory” and sub judice as the issues were under consideration by the HPCSA.

Carte Blanche opposed the application.

Advocate Warren Shapiro argued that both the Constitutional Court and the Supreme Court of appeal had determined that a “prior restraint” was a drastic interference with freedom of expression, which was only granted in narrow circumstances.

Judge Jikela said that while Duze claimed the broadcast would infringe on his right to dignity and may cause reputational harm, she was mindful that “any restriction on media reporting warrants careful and cautious consideration”.

“Several defences may be raised in response to an allegation of defamation. In this matter, [Carte Blanche] sets out the defences that directly address the core grounds on which [Duze] has based his case.

“Notably they contend that the broadcast in question centres on the personal accounts of his former patients, which are supported by medical records and independent expert opinion. Duze himself states that he consults, on average, 50 patients a day and he treats nearly every heart patient at Westville Life Hospital.

“In these circumstances, there is a compelling public interest in the dissemination of information concerning the conduct of a medical professional whose actions may pose a risk to the health and safety of current and future patients,” Judge Jikela said.

Carte Blanche had also said the intended broadcast included comments made honestly and in good faith which fell within the ambit of protected fair comment.

“It is trite that media publications on matters of public interest enjoy protection, provided they are made reasonably, without malice, and after taking reasonable steps to verify the information prior to publication,” the judge said.

Judge Jikela said Duze’s right to protect his reputation and professional standing was not absolute and it did not trump Carte Blanche’s constitutionally protected right to freedom of expression which includes the freedom of the press.

“Importantly, the public also has a legitimate interest in being informed about matters that concern public health and potential risks to patient safety.”

She said Duze had only made “vague references” to pending hearings and investigations. Duze had to show a real and demonstrable risk of substantial prejudice “as opposed to a remote possibility”.

“The HPCSA is not a court of law. The sub judice rule does not apply automatically to its processes.

“I do not believe that the broadcast will improperly influence the panel of medical professionals tasked with adjudicating the complaints against him, particularly where those complaints are supported by scientific and clinical evidence.”

Turning to the issue of the balance of competing rights, Judge Jikela said Carte Blanche had sought external objective opinions and had given Duze the right to reply.

“Media reports are vital in ensuring transparency, accountability and the protection of the public, particularly in sectors as essential as health care,” she said.

Medical practitioners had a duty to act in the best interests of patients. Where there were breaches of these obligations, the public had a constitutionally protected right to be informed.

“While the right to dignity and reputation must be respected, it cannot be invoked to shield conduct that may endanger lives or compromise patient care,” Judge Jikela said.

She said prior restraint had a “chilling effect” on the right to freedom of expression.

If the broadcast was indeed unlawful or defamatory, Duze could claim damages from Carte Blanche.

“The inconvenience of pursuing a damages claim does not outweigh the importance of safeguarding freedom of expression, particularly where the applicant [Duze] has not demonstrated irreparable harm or the falsity of the statements,” she said.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Read the original article.

Cardiologist “Gags” Carte Blanche

By Tania Broughton

Photo by Bill Oxford on Unsplash

A Durban-based cardiologist has secured a “gagging order” against Carte Blanche, stopping it from broadcasting a programme in which patients accuse him of medical malpractice for inserting stents unnecessarily.

Dr Ntando Peaceman Duze was given multiple opportunities for more than a week to respond to the allegations raised by his patients, which were corroborated by independent experts. But instead of responding, he launched an urgent application in the Kwazulu-Natal High Court in Pietermaritzburg on Friday.

He gave Carte Blanche only one day’s notice of the application.

Carte Blanche opposed it, arguing that Duze wanted to “bury these allegations for as long as possible if not indefinitely”, and that he was seeking an “unlawful prior restraint on freedom of speech and media”.

But Acting Judge Mpumelelo Sibisi granted an interim interdict, stopping the broadcast scheduled for Sunday 8 June.

Judge Sibisi said Duze needed to be given an opportunity to file a replying affidavit and that Carte Blanche had put a “gun to his head” to answer the questions posed to him. The judge said it would be appropriate to interdict the broadcast until the matter could be properly ventilated.

He set the return date for 13 June. But unless the matter is given a special allocation, it may not be argued and finalised on that day.

Cardiologists accused of defamation

Duze, who runs his practice from Life Westville Hospital, initially cited two other cardiologists in his application, seeking orders that they must desist from making “slanderous, insulting and defamatory remarks” about him.

He put this down to professional jealousy because their patients had moved over to his practice.

He alleged that the two cardiologists had instigated complaints laid by about seven of his patients against him with the Health Professionals Council of South Africa (HPCSA). He claimed that such was the professional jealousy, that he had been a victim of “witchcraft”, with chicken bones and red [Hindu] strings being left in the operating theatre.

He said the cardiologists had told his patients that “I had opened up their blood vessels” [an apparent reference to stent surgery], when it was unnecessary to do so.

Duze said the complaints to the HPCSA were “baseless”.

The cardiologists opposed the application.

Then on Friday, Duze’s legal team withdrew the claim against the cardiologists, and tendered to pay their legal costs. The lawyers gave no explanation for this. But it came in the wake of Carte Blanche, in its affidavit, saying they had not interviewed the cardiologists. Instead they had interviewed Duze’s aggrieved patients on camera and done follow-up investigations, including obtaining independent medical corroboration based on the patients’ medical records.

Gag order

Duze, in his application, said at any given time he had an average of 50 patients at the hospital, all with heart conditions. He had never before been reported to the HPCSA and, if the allegations against him continued and were made public on Carte Blanche, it would severely harm his reputation, “and may even lead to my financial demise”.

“Carte Blanche launched their own investigation and wants to broadcast a programme about this on Sunday 8 June, which I want to prevent, because it will be filled with untruths and defamation,” he said.

He said Carte Blanche had approached him for comment, and asked 14 specific questions, which he was not prepared to answer because the issue was “sub judice”.

“Once the [HPCSA] has completed its investigation, I will no doubt be willing to be interviewed and explain everything, because I will no doubt be cleared of these false allegations,” he said.

In her opposing affidavit, Carte Blanche producer Mart-Marie Faure said the application was an “abuse of process”.

“It is unsustainable on the facts and law and constitutes an impermissible attempt to obtain a pre-publication interdict in circumstances where no case has been made out for one and such an extreme order is not justified,” she said.

“The complaints, which form the subject matter of the inset entitled ‘Dr Stent’, were initiated by his patients, who had all, they allege, been subjected to unnecessary surgical procedures.

“Independent medical professionals who have been interviewed or consulted all confirm that the applicant [Duze] undertook unnecessary surgery that has had adverse consequences for his patients.

“This has nothing to do with jealous colleagues. The complaints are driven by his patients who allege serious medical malpractice with the most grave medical consequences.”

Faure said she had engaged with Duze and his attorneys for nine days in an attempt to secure answers to her questions “to no avail”.

“Carte Blanche was contacted by patients who claimed they were operated on unnecessarily. They consulted with other medical professionals who have said the insertion of stents was unnecessary. And in fact had caused heart disease when none was previously present.

“They will be required to take blood thinning and other medication for the rest of their lives.

“The HPCSA confirmed it received five complaints against the applicant.

“Life Healthcare has confirmed that it received information regarding allegations against the applicant from the HPCSA and has initiated an investigation.”

Faure said the complaints were not sub judice and that the explanation the doctor would advance to justify his conduct in that investigation would no doubt be the same he would give on camera or in a written response.

“If media houses were required to await the finalisation of proceedings before any professional or regulatory body, the public would be deprived of timely, relevant information on matters of pressing concern,” she said.

“This is antithetical to the very purpose of a free press.

“The patients’ accounts are based on their personal experiences and have been corroborated by independent experts. In every such story the person in respect of whom the investigation is conducted is unhappy. The remedy is to tell their side of the story, which the applicant has been repeatedly offered – not to gag the media.”

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Read the original article.

Webinar: Navigating the New HPCSA Booklet 19: The Ethics of Billing | 2 CPD Points

The healthcare sector is most effective when all stakeholders behave professionally and uphold ethical principles. Unethical practices are evident when stakeholders violate moral principles, ethical practices and organisational standards resulting in reduced productivity, decreased patient outcomes, increased patient risk and cost, fraud, and wastage.

Ethical practice is however linked to cultural values, context and workplace norms. As such, what may be viewed as unethical in one situation could be viewed as ethical practice in another. Unethical behaviour may therefore be unintentional and hence the importance of having clear guidelines on how to act in specific situations.

During this recorded webinar, healthcare providers will review the newly released HPCSA Booklet 19: Guidelines for Health Practitioners on Matters Relating to Ethical Billing Practices where the pertinent South African laws and basic principles around ethical billing practices are laid out. The live audience had an opportunity to engage with faculty who offered a clinical (Dr Simon Strachan, paediatrician in private practice and CEO of South African Private Practitioners Forum), legal (Deniro Pillay, Norton Rose Fulbright Admitted Attorney in the medical law and malpractice litigation sector), HPCSA (Mr Mpho Mbodi, HPCSA Head of Professional Practice division), medical malpractice insurance (Dr Hlombe Makuluma, EthiQal Medicolegal Advisor) perspective through short lectures, interactive case studies, a series of multiple choices questions (MCQs) and Q&A sessions.  

Healthcare professionals who watch this full webinar are entitled to claim 2 ethics CPD points. Instructions on how to claim points are covered in the webinar recording.

Watch the webinar at this link:  https://ethiqal.co.za/webinars/

Protecting People, Preserving Trust: Why Risk Management is Critical in SA Healthcare

Photo by cottonbro studio

What happens when trust – the cornerstone of healthcare – is broken? In South Africa, the answer is increasingly found in litigation. As medical malpractice claims soar and public confidence in health systems teeters, the call for urgent reform is unmistakable. At the centre of this complex issue lies a simple truth: Risk is inevitable but unmanaged risk is unforgivable.

Leandren Naidoo, Manager of Business Risk Solutions at OLEA South Africa, says, “Medical malpractice is more than a legal matter, it’s a profound rupture in the sacred relationship between healthcare providers and patients. At its core, it is about harm – physical, psychological and often, emotional. But it is also about dignity. Neuroscientific studies show that psychological injury registers in the brain in much the same way as physical harm. Yet, while a physical injury may receive swift attention, a bruised sense of dignity can linger and fester indefinitely.

Leandren Naidoo, Manager of Business Risk Solutions, OLEA South Africa.

“The perceived violation of dignity can fuel resentment, prolong trauma and, ultimately, drive patients to seek justice in courtrooms rather than consulting rooms.”

What is driving the rise in malpractice claims?

Across the globe, medical malpractice claims are on the rise.  In South Africa in 2023 a parliamentary report revealed that medico-legal claims, against the state, exceeded R78 billion, nearly tripling over the past decade. In high-risk disciplines like obstetrics, claims have risen by over 25% annually.

He says, “several forces are converging to create this perfect storm. Greater public awareness of patient rights, aggressive legal marketing and the adoption of ‘no win, no fee’ legal models have all made it easier to pursue claims.”

So, what does medical malpractice incorporate?

Errors and omissions, care related injuries, misdiagnosis, incorrect dispensing or prescription of medication, unnecessary surgery or treatment and medical equipment related injuries.

Court or conversation: What works best for resolving claims?

Naidoo says, “despite perceptions of rampant litigation, most malpractice cases never reach court. An estimated 95% of claims are resolved before trial, often on the proverbial courthouse steps. The reasons are manifold. Overloaded dockets, lengthy trial timelines (often five to seven years) and soaring legal costs.

“But there’s a deeper problem, courtrooms aren’t designed to resolve emotional trauma. Patients often seek validation more than victory,” he says, “They want to be heard, not just compensated.”

Why is risk management more urgent than ever?

In an environment where claims are increasing by 3 to 4% annually and legal defence costs are rising by 6 to 8%, risk management is no longer optional, it’s essential. It’s the only true defence healthcare providers have against both reputational damage and financial ruin.

What does effective risk management look like in practice?

  1. Patient safety protocols: Clear procedures to minimise errors, from surgical checklists to medication audits.
  2. Staff training: Empowering healthcare professionals with up-to-date clinical and legal knowledge.
  3. Record-keeping: Robust documentation that supports clinical decisions and protects against unfounded claims.
  4. Communication strategies: Cultivating a culture of transparency, apology and early intervention.
  5. Insurance alignment: Ensuring cover matches exposure, taking into account both damages and escalating legal fees.

Practitioners and medical institutions need to assess their limit of indemnity carefully. “An obstetrician can pay up to R1.7 million annually in premiums. This isn’t just a cost, it’s a risk exposure that needs to be planned for.”

What are the highest-risk disciplines and the cost of getting it wrong?

While all medical professionals face some risk, certain specialties are far more vulnerable:

  • Obstetrics: Cerebral palsy claims can reach R48 million
  • Neurosurgery: Brain and spinal complications
  • Orthopaedics: Post-surgical disabilities
  • Emergency medicine: Delays or misdiagnosis

Average claim amounts range between R300 000 and R12 million. High-end cases, particularly involving children, can exceed R40 million. This is because claims, involving minors, extend the period of prescription until three years after they reach 18, significantly increasing potential compensation.

Can the right insurance really make a difference?

“Absolutely,” says Naidoo. “Medical malpractice indemnity insurance provides cover for the following: Arbitration costs, court judgement and awards made against the insure, expert legal fees and support, court costs, settlement costs and attorney’s (and mediation) fees.”

Insurance is not merely a financial product, it’s a strategic partnership. A good insurer doesn’t just pay claims, they help prevent them. At OLEA South Africa, for instance, brokers conduct detailed situational audits of healthcare institutions to assess operational risks.

“As brokers we advise which insurer will be the most effective for that particular institution or medical practitioner. It’s about education, not just insurance,” Naidoo explains. “We want to develop a system and environment where malpractice is unlikely. But, if it does happen, the tools must be available to resolve it constructively.”

Is the media making things worse?

Yes and no.  On the one hand, media coverage of high-profile cases has increased accountability. On the other, it has inflated public expectations. Patients increasingly equate any adverse outcome with negligence, leading to an uptick in opportunistic claims.

Moreover, the rise of “ambulance chasing” has introduced a dangerous incentive structure. In 2024 alone, the SIU flagged over 2 800 suspicious malpractice cases, many driven by legal marketing, rather than genuine harm.

This places additional pressure on doctors, who may resort to defensive medicine, ordering unnecessary tests, referrals or procedures. Not to improve care but to avoid liability.

Most importantly, healthcare institutions must view risk management not simply as a compliance exercise but as a moral imperative.

And final words from OLEA South Africa

  • We value our healthcare practitioners immensely. To our doctors and nurses, you carry the weight of life and death every day. But you shouldn’t carry it alone. Equip yourselves with the tools, training and protection you need to do your job with confidence
  • To insurers and brokers: Be more than policy providers. Be educators, allies and defenders of dignity
  • To patients: Know your rights but also recognise your responsibilities. Healthcare is a partnership, not a transaction
  • And to policymakers: Prioritise patient safety, not just with funding but with forward-thinking reforms that streamline resolution, reduce conflict and restore trust

Because, at the heart of it all is one shared goal. Protecting people. And there’s no greater purpose in healthcare than that.

The Evolution of AI in Patient Consent is a Data-Driven Future

Henry Adams, Country Manager, InterSystems South Africa

One area undergoing significant evolution in the healthcare industry is the process of obtaining patient consent. It is a topic that is highly controversial but absolutely necessary and one that must evolve if we are to bring patient care into the 21st century.

Traditionally, patient consent has involved detailed discussions between healthcare providers and patients, ensuring that individuals are fully informed before agreeing to medical procedures or participation in research. However, as artificial intelligence (AI) becomes more prevalent, the mechanisms and ethics surrounding patient consent are being re-examined.

The current state of patient consent

Informed consent is a cornerstone of ethical medical practice, granting patients autonomy over their healthcare decisions. This process typically requires clear communication about the nature of the procedure, potential risks and benefits, and any alternative options.

In the context of AI, particularly with the use of big data and machine learning algorithms, the consent process becomes more complex. Patients must understand not only how their data will be used but also the implications of AI-driven analyses, which may not be entirely transparent.

The rise of dynamic consent models

To address these complexities, the concept of dynamic consent has emerged. Dynamic consent utilises digital platforms to facilitate ongoing, interactive communication between patients and healthcare providers.

This approach allows patients to modify their consent preferences in real-time, reflecting changes in their health status or personal views. Such models aim to enhance patient engagement and trust, providing a more nuanced and flexible framework for consent in the digital age.

AI has the potential to revolutionise the consent process by personalising and simplifying information delivery. Intelligent systems can tailor consent documents to individual patients, highlighting the most pertinent information and using language that aligns with the patient’s comprehension level. In addition, AI-powered chatbots can engage in real-time dialogues, answering patient questions and clarifying uncertainties, enhancing understanding and facilitating informed decision-making.

Data privacy, ethical and security considerations

The integration of AI into patient consent processes necessitates an increased attention to data privacy and security. As AI systems require access to vast amounts of personal health data, robust additional safeguards must be in place to protect against unauthorized access and breaches. Ensuring that AI algorithms operate transparently and that patients are aware of how their data is being used is critical to maintaining trust in the healthcare system, and AI in particular.

While AI can augment the consent process, the ethical implications of its use must be carefully considered. The potential for AI to inadvertently introduce biases or operate without full transparency poses challenges to informed consent. Therefore, human oversight remains indispensable.

Healthcare professionals must work alongside AI systems, the “human in the loop”, to ensure that the technology serves as a tool to enhance, rather than replace, the human touch in patient interactions.

The next 5-10 years

Over the next decade, AI will become increasingly integrated into patient consent processes. Experts predict advancements in natural language processing and machine learning will lead to more sophisticated and user-friendly consent platforms. However, the centrality of human judgment in medical decision-making is unlikely to diminish. AI can provide valuable support, but the nuanced understanding and empathy of healthcare professionals will remain vital.

So, as we take all of this into account, the evolution of AI in patient consent processes offers promising avenues for enhancing patient autonomy and streamlining healthcare operations. By leveraging AI responsibly, healthcare institutions can create more personalised, efficient, and secure consent experiences.

Nonetheless, it is imperative to balance technological innovation with ethical considerations, ensuring that human judgment continues to play a pivotal role in medical decision-making. As we navigate this new world, a collaborative approach that integrates AI capabilities with human expertise will be essential in shaping the future of patient consent. And for healthcare in South Africa, this is going to have to start with education.

Déjà Vu: Moss v Road Accident Fund

Photo by Tingey Injury Law Firm on Unsplash

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.

  1. [2025] JOL 68686 (WCC). ↩︎
  2. [2025] ZAWCHC 27. ↩︎

Court Rules that UTI Drug Trade Names are Too Similar

Photo by Bill Oxford on Unsplash

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.”