Pretoria, 28 September 2025 – The South African Health Products Regulatory Authority (SAHPRA) wishes to reassure the public that paracetamol remains a safe and recommended option for the relief of pain and fever during pregnancy, when used short-term at recommended doses.
Paracetamol is one of the most widely used medicines globally and has been extensively studied for decades. There is currently no scientific evidence that using paracetamol in pregnancy causes attention-deficit hyperactivity disorder (ADHD) and autism.
SAHPRA will continue to monitor emerging evidence on the safety of paracetamol.
Advice for healthcare professionals
Paracetamol remains a recommended safe treatment for pain or fever in pregnant women. Pregnant women should be reassured that there is no evidence that taking paracetamol during pregnancy causes autism or ADHD in children. Healthcare professionals are encouraged to provide counselling to patients about the side effects of paracetamol, as detailed in the product’s professional information and patient information leaflet (https://pi-pil-repository.sahpra.org.za/).
Advice for healthcare professionals to provide to patients
Pregnant women and those planning a pregnancy should be advised to use paracetamol only when needed and at the lowest effective dose for the shortest possible time. Untreated fever and pain may pose risks to the unborn baby, and it is therefore important to seek treatment if recommended by a healthcare professional. Pregnant women should consult a healthcare professional if pain or fever persists or if they have any concerns about medicine use during pregnancy. Pregnant women should also be advised to avoid combining paracetamol with other medicines without first seeking medical advice.
Report any suspected adverse drug reactions
Healthcare professionals and members of the public are urged to report any suspected adverse drug reactions (ADRs) related to the use of paracetamol and other health products to SAHPRA via the eReporting link available on the SAHPRA website (www.sahpra.org.za) or complete an ADR reporting form accessible via the SAHPRA website and email it to adr@sahpa.org.za. Alternatively, reporting can be done via the Med Safety App, downloadable through Google Play or the Apple App Store.
SAHPRA remains committed to ensuring the safety of medicines available in South Africa and will update the public if new scientific evidence changes current recommendations.
Most medical devices are used in healthcare settings but some like bandages, thermometers, condoms, and blood pressure monitors are used at home. Photo by Mockup Graphics on Unsplash
By Catherine Tomlinson
Unlike with medicines, and with a few exceptions, South Africa’s regulator does not assess whether diagnostic tests and other medical devices on the market are safe and work as they are supposed to. The regulator has however started down a road that should eventually lead to the regulation of all medical devices in the country.
From scalpels to surgical robots, finger-prick diagnostic tests to MRIs, thermometers to wearable AI-powered health monitoring devices, bandages to prosthetics: the range of products classified as medical devices is vast.
Some medical devices are used briefly and then disposed of after a single use, while others are designed to stay in our bodies for long periods of time, such as implants to prevent pregnancy and pacemakers to help the heart beat regularly.
While most medical devices are used in medical settings, some, like bandages, thermometers, condoms, and blood pressure monitoring devices, are used at home.
The World Health Organization estimates that there are more than two million different types of medical devices used around the world. Given the enormous diversity of medical devices, it can be tricky to see what links all these products together.
One answer, and essentially the one used in South African law, is that it is the intended use of the device. A medical device is thus simply any device that is intended to be used to prevent, diagnose, monitor, or treat a disease, injury, or other medical condition.
Because medical devices are sold for medical purposes, they require regulatory oversight to ensure that they are safe to use and work as intended. But in South Africa, this regulatory oversight is not yet fully in place, and you can’t always trust that devices do what they claim to do, or that tests are accurate.
‘Inaccurate readings’
On a recent webinar hosted by FIND, an international non-profit engaged in the development of diagnostics for low resource settings, the chairperson of NGO SA Diabetes Advocacy, Kirsten de Klerk, told participants that “a lot of people assume that if a medical device is available for purchase, it has been correctly tested and approved for use” but “unfortunately, that’s not the case”.
De Klerk added: “I have unfortunately had community members sharing stories of life-threatening situations because of inaccurate readings” from continuous glucose monitors (CGMs). These are medical devices used by people with diabetes to monitor their blood sugar level.
To address the challenge of poor-quality CGMs on the market, South African diabetes advocates and FIND launched a tool to assist people with diabetes and healthcare providers to identify and use monitors that have been properly assessed for safety and functioning.
But what role does the South African Health Products Regulatory Authority (SAHPRA) play in ensuring the safety and effectiveness of medical devices used in the country, and what steps is it taking to better protect the public?
A mandate to regulate
Though medical devices aren’t yet registered, SAHPRA does have a legal mandate to regulate medical devices. The relevant legal requirements were introduced in the 2015 Medicines and Related Substances Amendment Act 14. Before the 2015 Amendment Act came into force in 2017, only electromagnetic or radiation-emitting medical devices were regulated in South Africa.
The 2015 amendments provided for the establishment of SAHPRA to replace the Medicines Control Council as the country’s health products regulator and expanded SAHPRA’s regulatory scope to cover all medical devices.
SAHPRA’s first big move towards regulating the medical device industry was to introduce requirements for medical device companies to be licensed as medical device establishments. Medical device companies were informed that they would need a medical device establishment license to operate in the country in a government gazette notice issued in 2017. (Manufacturers of the lowest risk products – Class A medical devices that don’t have a measuring function and/or are not required to be sterile – are currently exempt from the licensing requirements.)
Today, over 2 500 companies hold active medical devices establishment licenses from SAHPRA. In their applications for these licenses, companies must list the medical devices that they will manufacture, import, or wholesale in South Africa and the establishment licenses that they are granted are specific to the class of products that they are manufacturing or handling.
Medical devices are classed in four groups from lowest to highest risk products, based on the risk posed by the product to patients and the broader public health. Bandages for example are classed as low risk, while heart valves are classed as high risk. Using a risk-based approach allows SAHPRA to harmonise how medical devices are regulated in South Africa with international norms and will allow the regulator to prioritise review of high-risk products as it phases in requirements for registration of medical devices used in the country.
In addition to listing the devices that they manufacture, distribute, or wholesale, companies seeking medical device establishment licenses from SAHPRA are also required to provide a declaration regarding the quality management systems that they have in place.
Critically, however, the devices themselves are not yet being assessed by SAHPRA.
Dr Dimakatso Mathibe, senior manager of SAHPRA’s medical device unit, told Spotlight that more than 200 000 different medical devices are used in South Africa. While over two thousand companies hold active medical device establishment licenses, she explained that a single company may be importing over a hundred products. She noted that as SAHPRA has increased the regulatory requirements for operating in South Africa, some medical device companies have voluntarily withdrawn from the market.
ISO 13485 certification
SAHPRA’s second big move, which is now being rolled out, is the introduction of requirements for medical device companies to gain ISO 13485 certification verifying that they meet international quality management standards.
Medical device companies operating in South Africa can receive certification that they meet ISO 13485 standards from an international or local conformity assessment body that has been accredited to provide this certification.
When SAHPRA first introduced medical device establishment licenses, it did not require companies to have ISO 13485 certification, as it was concerned that enforcing this too quickly could disrupt access to medical devices in the country. This was in part due to the lack of local conformity assessment bodies accredited by the South African National Accreditation System (SANAS) to grant this certification at the time.
John Ndalamo, accreditation manager for SANAS’ certification programme, told Spotlight that six local conformity assessment bodies have now been accredited to provide ISO 13485 certification.
SAHPRA now requires that companies renewing their five-year medical device establishment licenses provide either proof of ISO 13485 certification or evidence that the company has begun the process of seeking this certification.
What about regulation of the actual devices?
While important strides have been made by SAHPRA toward regulating the medical device industry, medical devices themselves still remain mostly unregulated in South Africa.
What this means is that, as pointed out by SA Diabetes Advocacy, medical devices may currently be marketed in the country without an independent regulator confirming that they are safe to use and perform as advertised.
The registration of the over 200 000 medical devices in use in the country is a mammoth job. Mathibe said that when SAHPRA introduces requirements for the registration of medical devices, it will do so in a phased and transitional manner. She explained that the call-up of medical devices for registration will likely be phased by product risk classes and conditions. Presumably, SAHPRA will start with the highest risk products and work down from there.
Assessing feasibility
SAHPRA is conducting a feasibility study of its intended approach to register medical devices. Companies holding medical device establishment licenses have been asked to voluntarily participate in the study.
In documentation published for the feasibility study, SAHPRA indicated it plans to include 32 medical devices used for HIV and TB in the study. These will cover in vitro diagnostic tests, condoms, and X-ray devices used for TB screening.
SAHPRA also aims for half of the products included in the study to be manufactured locally and the other half to be imported. In doing so, SAHPRA can use the study to test its approach for registering products that are evaluated locally, as well as products assessed in other countries with which it has a regulatory reliance mechanism in place (meaning it can rely on regulatory evaluations performed in these countries).
How will safety and performance be assessed in the feasibility study?
Mathibe said that SAHPRA will not directly assess the safety and performance of medical devices in the feasibility study. Instead, this will be done by accredited conformity assessment bodies, which is the same approach used by regulators in Europe. The assessment made by the conformity assessment bodies will then be used by SAHPRA in determining whether a product should be approved for use in the country.
For medical devices already registered in jurisdictions with which SAHPRA has a reliance mechanism in place, like the European Union, Australia, and Japan, companies can submit evidence of such conformity assessments and marketing approval. SAHPRA can then use this information to help make its own registration decisions.
Devices that are not approved by a regulatory authority recognised by SAHPRA, must undergo a safety and performance assessment by a locally accredited conformity assessment body.
Mathibile said insights from the study will be shared with stakeholders next year, and the lessons will help inform how SAHPRA introduces medical device registration in South Africa.
Emergency authorisation of COVID-19 and Mpox medical devices
While SAHPRA has not yet registered medical devices, it introduced rules in 2020 for emergency authorisation listings for certain medical devices used for COVID-19 in South Africa, and it announced in 2024 that diagnostic tests for Mpox required approval from SAHPRA before they could be used in the country.
SAHPRA has thus “listed” multiple COVID-19 tests and two Mpox diagnostic tests as approved for use in South Africa. Khanyisile Nkuku of SAHPRA’s medical devices unit told Spotlight that the diagnostic products for COVID-19 and Mpox received interim Section 21 authorisation.
Section 21 authorisation allows for the use of unregistered products under certain conditions, including public health emergencies. This mechanism has been used by SAHPRA both to respond to the public health needs posed by COVID-19 and Mpox and to prevent the use of substandard products, which was a challenge faced in the early days of COVID-19.
Nkuku added while South Africa has had a relatively low number of Mpox cases, South Africa is a leading supplier of in vitro diagnostics to the rest of the continent, including countries facing large Mpox crises, and so SAHPRA shares the responsibility of ensuring that Mpox diagnostics used on the continent work properly and is working with the African Medicines Regulatory Harmonisation programme to review Mpox diagnostics.
By Matimba Ngobeni, Country Head: Value & Access, Novartis South Africa
28 July 2025, Johannesburg South Africa – South Africa’s healthcare system stands at a crossroads. Despite the promise of progress outlined in the Budget Speech and the Presidential Health Compact, the reality on the ground reveals persistent and growing barriers to accessing innovative medicines.
Economic pressures, funding constraints, and infrastructure gaps continue to undermine equitable healthcare delivery, particularly for vulnerable communities. What’s more, recent international developments—such as U.S. President Donald Trump’s cuts to funding that supported healthcare initiatives in South Africa—threaten to exacerbate these challenges, potentially limiting access to life-saving advanced therapies.[1]
Economic pressures
The cost of advanced therapies remains out of reach, and the structural inequalities in our healthcare system persist. While top-tier medical plans still provide access to advanced medicines, we are seeing a shift. Patients are moving to lower-tier plans or into the public system, simply because they cannot afford more. And with that shift, their access to advanced therapies disappears. [2]This is not a uniquely South African problem.
Globally, we see the same story repeat: private healthcare becomes a fortress that only those who can pay the toll may enter. Everyone else is left to rely on an overburdened public system, strained by funding shortfalls, infrastructure gaps, and critical workforce shortages. The public healthcare system, already overburdened, struggles to absorb this increased demand. Rising healthcare costs combined with limited household budgets create a perfect storm where affordability becomes the biggest barrier to accessing cutting-edge treatments.
Funding constraints and infrastructure challenges
Both private and public sectors face severe funding constraints. Innovative medicines, especially advanced therapies, come with high price tags that strain budgets and limit availability. At the same time, infrastructure and skills gaps hinder the effective delivery of these treatments. Investments in healthcare infrastructure, workforce training, and data management are urgently needed to support the growing demand for advanced therapies.
While it may seem like all hope is lost, the Presidential Health Compact offers a promising framework aimed at transforming South Africa’s healthcare landscape through infrastructure development and improved data surveillance[3]. However, it stops short of directly addressing access to innovative medicines. This gap underscores the need for stronger collaboration between public and private stakeholders to ensure that patients do not bear the financial burden alone.
Towards equitable access: Collaboration is imperative
Another way forward is through a robust, transparent Health Technology Assessment (HTA) process, where medicines are evaluated not only on their cost but on their ability to save lives, improve quality of life, and reduce the long-term burden on the health system.
Inclusive HTAs, where payers and pharmaceutical companies work together, are essential for reimagining access to advanced therapies. If we only look at the upfront cost of innovation, we miss the bigger picture of societal value.
Globally, risk-sharing models and outcome-based pricing agreements are helping bridge the affordability gap[4]. South Africa could benefit from more flexible legislation to enable these models, ensuring that innovation doesn’t remain locked behind prohibitive price tags.
South Africa’s healthcare future depends on what we choose to prioritise: short-term financial gains or long-term societal wellbeing. Too often, systems have been designed around protecting profits rather than protecting lives. Healthcare should never be a luxury. Yet in South Africa, and across much of the world, the reality is stark: exclusion is the norm, not the exception.
If we want a future where access to life-saving medicines is a reality for all, we need to break down the barriers of affordability, infrastructure, and policy inertia. And we need to do it together — governments, healthcare companies, funders, and civil society — because lives are at stake.
All hope is not lost. But we cannot wait for crisis to be our catalyst. The time for bold, collaborative action is now.
**About Novartis:**
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.
Novartis South Africa (Pty) Ltd, Magwa Crescent West, Waterfall City, Jukskei View, 2090. Co. Reg. No. 1946/020671/07. Tel. No. +27 (0) 11 347 6600.
Disclaimer: The presentation may include data on formulations, products, indications, and dosages not yet approved by the South African Health Products Regulatory Authority. This information is not intended to be promoting nor recommending any formulation, indication, dosage, or other claim not covered in the approved Professional Information. Novartis South Africa (Pty) Ltd recommends the use of their products in accordance with the locally approved Professional Information. Views and opinions of speakers do not necessarily reflect those of Novartis.
Pretoria, 15 July 2025 – The South African Health Products Regulatory Authority (SAHPRA) was notified of the Lancet Global Health 2025; 13: e1250, an investigational study and its findings on substandard anti-cancer medications in Sub-Saharan African countries, including Ethiopia, Kenya, Malawi, and Cameroon. This study did not include South Africa. The seven (7) medicines/dosage forms mentioned in the study are cisplatin, oxaliplatin, methotrexate, doxorubicin, cyclophosphamide, ifosfamide, and leucovorin. The specific brands mentioned/shown in the article are neither registered nor marketed in South Africa.
SAHPRA, in terms of the Medicines and Related Substances Act 101 of 1965, as amended, and its General Regulations, requires medicines marketed in the country to meet prescribed requirements and adhere to set standards. Every batch of medicine produced must undergo testing to ensure that the integrity of the product is consistent with approved specifications before the release for sale, and imported medicines must additionally comply with the Guideline for Post-Importation Testing.
SAHPRA commenced internal processes to verify whether any of the South African-registered cancer medicines with the mentioned Active Pharmaceutical Ingredients (API) might have been affected or implicated. The cancer products registered and marketed in South Africa were not implicated/affected by the investigational study and its findings on substandard anti-cancer medicines. SAHPRA conducts risk-based post-market surveillance (PMS), sampling, and testing on high-risk medical products.
SAHPRA is satisfied that the marketed and registered cancer medicines meet the appropriate specifications; therefore, no substandard cancer medicines were detected.
“SAHPRA is committed to the three pillars of quality, safety, and efficacy. I am satisfied that our rigorous regulatory processes have borne fruit and that all patients, especially cancer patients, can rest assured that their health and well-being are not compromised,” indicated SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
The South African Health Products Regulatory Authority (SAHPRA) has joined the Medical Device Single Audit Programme (MDSAP), an international audit programme of medicines and medical device regulators aimed at improving efficiencies in the regulation of medical device manufacturers by engaging in work sharing and collaboration. SAHPRA joins MDSAP as an affiliate member, which expands its ability to monitor the manufacturing of medical devices beyond South Africa’s borders.
The MDSAP membership will result in the improved regulation of medical devices and in-vitro diagnostics (IVDs) as it increases SAHPRA regulatory reach and ensures that SAHPRA can leverage the resources of other regulators that participate in the MDSAP to both audit and monitor adherence to quality standards by medical device manufacturers in several countries globally.
“SAHPRA’s admission into MDSAP signals progress in our strategy to ensure the efficient application of our own resources and those of our peers globally in safeguarding the quality, efficacy and safety of medical devices and in-vitro diagnostics (IVDs) used by the South African public,” says Dr Boitumelo Semete-Makokotlela, SAHPRA Chief Executive Officer.
Dr Semete-Makokotlela says that the admission to MDSAP adds to individual agreements for both monitoring and regulatory reliance that SAHPRA already has in place with several regulators the world over, and would thus improve SAHPRA’s quality assurance abilities and has the potential to increase turnaround times in reviewing and approving key medical devices manufactured elsewhere in the world.
The South African Health Products Regulatory Authority (SAHPRA) encourages members of the public to always report any suspected side effects they may experience from taking medicines, vaccines and/or using medical devices, to help make medicines safer for everyone. While humanity benefits greatly from medicines in the treatment of illness and management of certain conditions, medicines may at times cause side effects. However, the risk of side effects and severe harm can be drastically reduced by taking medicines correctly and following the advice of a healthcare practitioner.
SAHPRA, together with over 90 other medicines and health products regulators as well as healthcare organisations globally, is participating in the annual #MedSafetyWeek awareness initiative, which takes place between 4 and 10 November 2024, under the theme “the importance of using medicines in the right way to prevent side effects, and to report side effects when they do occur”.
The awareness initiative is spearheaded by the Uppsala Monitoring Centre under the auspices of the World Health Organisation (WHO) Programme for International Drug Monitoring, a programme whose member organisations work nationally and collaborate internationally to monitor and identify adverse effects of medicines and vaccines, to reduce risks to patients, and to establish worldwide pharmacovigilance standards and systems.
During this #MedSafetyWeek and beyond, SAHPRA is calling upon patients, caregivers and healthcare professionals to utilise its reporting tools to report all suspected side effects and adverse reactions.
SAHPRA Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, indicates that handling and storing as well as taking medicines as directed by a healthcare professional is key in reducing the incidence of adverse reactions. “Research shows that about half of all side effects are preventable. Patient safety is our top priority and during #MedSafetyWeek, we wish to remind patients to take their medicines as instructed and healthcare professionals to review therapies as well as each patient’s unique health conditions before prescribing or dispensing medicines,” says Dr Semete-Makokotlela.
SAHPRA calls upon the South African public and healthcare professionals to use either the MedSafety App or the eReporting portal both accessible on the SAHPRA website to report suspected side effects from health products. All reports are assessed and examined by SAHPRA to determine the correct steps to protect medicine users in South Africa from harm. The purpose is to gain better knowledge about known side effects and to discover new ones. This can result in warnings and changes to how a medicine is used. SAHPRA’s MedSafety App and eReporting portal can be used for reporting suspected adverse drug reactions from medicines, vaccines, herbal products, biological medicines and any quality issues relating to health products.
The South African Health Products Regulatory Authority (SAHPRA) and the Australian Therapeutic Goods Administration (TGA) have signed a Memorandum of Understanding (MoU), which will strengthen collaboration between the two health product regulators.
The MoU builds on the existing relationship between the health products regulators to improve capabilities in the assessment of medical products and therapeutic goods and their monitoring for continued efficacy, safety and quality once they are registered.
Areas of cooperation
SAHPRA and TGA will engage in data sharing aimed at improving the regulatory functions executed by both regulators. This will particularly focus on the assessment and approval of medical products and therapeutic goods, their monitoring for continued efficacy, and the surveillance for safety and adverse reaction (event) concerns.
According to SAHPRA’s Chief Executive Officer, Dr Boitumelo Semete-Makokotlela, the agreement with the TGA expands the geographical reach for both regulators’ pharmacovigilance programmes and augments their internal expertise.
“This partnership enables us to rely on each other’s strengths and regulatory outputs in the evaluation of health products both before they are registered and once they are approved for public use. This would improve therapeutic outcomes for the populations we exist for and increase the robustness of our post-registration surveillance for efficacy, safety and quality,” says Dr Semete-Makokotlela.
Deputy Secretary at the Australian Government Department of Health and Aged Care and head of the TGA, Professor Anthony Lawler, said: “TGA is very pleased to have strengthened our collaborative relationship with SAHPRA with the signing of this international agreement. We look forward to working alongside our regulatory counterparts in South Africa to share important regulatory information to ensure the continued safety, quality and efficacy of therapeutic products approved for market.”
In a press release, the South African Health Products Regulatory Authority (SAHPRA) has hit back over what it terms “unfounded fallacies and misrepresentation” that has been “churned out by some media organisations without verification” over its draft B-BBEE Policy.
SAHPRA states that this policy “is proposed in order to comply with requirements of the Broad-Based Black Economic Empowerment Act, 53 of 2003, in particular Section 10(1)(a), which demands of all state entities to enact policy that can encourage inclusive economic participation.”
It states that the draft B-BBEE policy does not set “racial requirements” for the registration of medicines, as the first falsehood suggests, stating that it is not reflected in any of the documents.
The second falsehood is that “SAHPRA will use the B-BBEE to assess medicine registration applications and thus affect access to medicines”, which it says is a deliberate misrepresentation. The product registration processes “would continue to solely rely on the safety, quality, efficacy, and performance of the health products.”
The third falsehood is that the draft policy is aligned with NHI, seeking to exclude certain persons from state procurement. SAHPRA says that the policy is a move develop sector codes and/or criteria to comply with the B-BBEE Act, as has been done in other sectors of the economy.
SAHPRA states that the fourth and final falsehood is that the policy will deny participation by pharmaceutical SMEs as they may be unable to get B-BBEE certificates. The agency contends that compliance affidavits will be an acceptable alternative, and that in any case, the B-BBEE level of a business does not affect the medicines registration process – which will remain the case even after policy implementation.
The South African Medical Association has for years raised concerns about the criminalisation of medical errors, stressing that current legal practices may undermine patient safety and deter doctors from performing high-risk procedures.
Individual healthcare workers or teams of healthcare workers, like all other people, sometimes make unintentional errors. Though public recognition of the problem may be lacking, there is substantial scientific literature recording and describing the issue. In its landmark “To err is human” report published in 1999, the United States Institutes of Medicine wrote that “the problem is not bad people in health care – it is that good people are working in bad systems that need to be made safer”.
Medical errors can take many forms – from diagnostic and surgical, to medication and device and equipment. Pinning down a definition is hard although two formulations in academic literature are: “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim” and “unintentional deviation from safe practice”. Some argue against the use of the term “errors”, given that it stigmatises those who make “errors”.
A variety of approaches have been used to reduce medical errors. One of the most striking is the use of aeroplane-style checklists before and during surgery – with one such checklist having been backed by the World Health Organization. A review of such checklists published in the British Medical Journal in 2012 concluded that “surgical checklists represent a relatively simple and promising strategy for addressing surgical patient safety worldwide”.
Error v negligence
While the terms medical errors and medical negligence are often used interchangeably, they are in fact quite distinct, explains Professor Ames Dhai, SAMA’s vice chairperson and former director of the Steve Biko Centre for Bioethics at Wits University, in an interview with Spotlight.
“Medicine is exceedingly complex and errors do unfortunately occur from time to time (in most instances no harm comes from them). In most instances, the error cannot be attributed to the ‘fault’ of a person and is just a consequence of the procedure or other systemic factors.” The element of “fault”, Dhai says, is what distinguishes errors from medical negligence. Medical negligence occurs, she says, when the standard of care fails to meet the expected standard of the reasonable doctor in that discipline under the prevailing circumstances, leading to the patient suffering harm.
“If the ‘fault’ is deemed to be intentional, one is no longer negligent, and [therefore] potentially guilty of murder (the distinction being negligence vs intent),” Dhai explains.
“To be clear, doctors who are grossly negligent or reckless need to be held accountable. However, nearly all doctors don’t fall into this category. They are ethical, caring, and only want the best for their patients,” she says.
According to SAMA, due to a lack of proper, transparent structures to investigate, explain, account, and resolve instances of medical errors, families understandably turn to the criminal justice system for answers and accountability. This means some cases end up in court.
One high-profile case is that of paediatric surgeon Professor Peter Beale, who faces multiple charges, including three counts of murder and two of fraud, linked to the deaths of three children between 2012 and 2019. The state claims the deaths were caused by wrongful and negligent actions and unnecessary procedures by Beale.
But SAMA argues that the criminal justice system, designed for addressing criminal acts, is not the most suitable mechanism to navigate the complexities of medical practice. They stress that their concerns about charging, prosecuting, and convicting doctors in no way seek to minimise the impact of such devastating events on the families and loved ones involved.
“Instead, we are worried that criminalisation of bona fide medical errors and adverse events is an unsuitable response that would do little to prevent future tragedies and may in fact lead to other unwanted consequences that would be detrimental to both the profession and patients,” explains SAMA chairperson Dr Mvuyisi Mzukwa. He argues that criminalising errors would potentially ensure that they will be concealed and unreported, adding that “by hindering disclosure and reporting, one stifles opportunities to learn from errors and improve the system”.
But not everyone agrees. Dr Siraaj Khan, a lecturer at the Steve Biko Centre for Bioethics, describes the relevant law as straight-forward and says it is not in need of reform. “I think we need to differentiate being charged with medical negligence in a criminal court and being held liable or found guilty at the end of the day. And you’ll see that there are very few instances where a medical practitioner is actually found guilty,” he says. “So in my opinion, the law as it stands doesn’t require any intervention.”
Khan points out that if a medical doctor makes an error, it doesn’t automatically mean that they are negligent. The error has to be one that a reasonable doctor in the position of that particular medical doctor would not have made. Only if the standard falls short of the reasonable expert in that position will the conduct be criminalised, and that needs to be proven beyond a reasonable doubt in a criminal court. “So it’s a higher standard than that used in a civil court,” says Khan. “In a civil court, if there’s an action for medical negligence, it just needs to be proven on a balance of probabilities. Whereas if you charge a doctor with culpable homicide, for example, the standard of negligence needs to be proven beyond a reasonable doubt in a criminal court.”
But Dhai is critical of the status quo. She argues that the law, as it stands and as it is applied, may hamper patient safety and the achievement of a safety culture (where systems thinking, rather than individual blame, is applied to learn from incidents to create better systems and provide safer care). “The criminal justice system often ignores systemic factors to instead target the individual who happened to hold the scalpel when the incident occurred,” she says.
“The environment of fear and the threat of litigation and criminal proceedings may also disincentivise doctors from practicing in high-risk specialties or operating on complex and difficult cases, thereby impeding access to much-needed care,” Dhai adds. Khan acknowledges the argument that criminalising medical errors encourages defensive medicine, but, “on the other hand”, he says, “the counter-argument is that if we do criminalise this, it sets the standard and it would require doctors to act with more prudence when performing these operations”.
Gross negligence
SAMA’s position is that the threshold for criminal proceedings should be elevated from negligence to gross negligence and recklessness. As pointed out by Larisse Prinsen, a senior law lecturer at the University of the Free State, in an article published by The Conversation, gross negligence is the standard in countries such as New Zealand, Australia, and England. SAMA also says that investigators and the National Prosecuting Authority (NPA) should be specially trained to fully appreciate the complexities involved in medical errors and adverse events. The NPA is responsible for criminal prosecutions in South Africa.
Photo by Tingey Injury Law Firm on Unsplash
In addition to increasing the threshold for prosecution from negligence to gross negligence or recklessness, Dhai argues that there is much more that needs to be done. This includes better application of the law, including better complaint management, alternative dispute resolution, and support for affected patients and health practitioners.
Changes to the relevant laws might well be on the way.
The South African Law Reform Commission (SALRC) has confirmed to Spotlight that they “received a request from a coalition of various healthcare-related bodies asking that the SALRC conduct an investigation to review the law of culpable homicide and the application thereof in a healthcare setting”. According to the SALRC, the request was approved by the Minister of Justice and Correctional Services on 27 June 2023 and the research is underway as “Project 152 Criminal Liability of Healthcare Professionals”.
Though much of SAMA’s current spotlight is on criminalisation of medical errors, South Africa does also have a much wider challenge of medico-legal claims against provincial health departments. Most of these claims are for alleged medical negligence relating to birth-related complications, particularly cerebral palsy. Though amounts paid out are a small fraction of total claims, they nevertheless amount to hundreds of millions per year and are a severe strain on provincial health budgets. A bill aimed at addressing state liability in such cases was introduced in the last parliament, but has not been passed. The SALRC has for several years also been looking at the issue of medico-legal claims and published a discussion paper on the matter in November 2021, though more than two years later, their final report on the matter has not yet been published.
What about the HPCSA?
The Health Professions Council of South Africa (HPCSA) regulates health professions in the country. This involves, among others, managing the licensing of doctors.
As explained in an article by the Medical Protection Society’s Dr Yash Naidoo, less serious complaints made to the HPCSA are handled through a process of mediation. If complaints are more serious, or if mediation fails, a formal complaints process kicks in. In some cases, this can turn into a formal professional conduct inquiry.
“When a matter proceeds to a formal inquiry, that is when costs – money and time – start to escalate,” writes Naidoo.
“Think of the inquiry as you would a typical courtroom matter on television. The complainant is represented by the HPCSA’s pro forma complainant, and the practitioner is the respondent who may have their own legal representation. Each party can call witnesses and the inquiry itself can take a day or more – depending on the number of witnesses and the complexity of the matter.”
As Naidoo explains, penalties can range from a caution or reprimand to large fines or removal from the register (which amounts to the person no longer being allowed to work as a health professional).
Speaking to Spotlight, HPCSA’s Acting Head of Division Corporate Affairs, Priscilla Sekhonyana, says that the HPCSA has a dedicated line for lodging complaints and investigating authority and committees for adjudication of matters. “The HPCSA has committees of experts in place to adjudicate on matters and all rules of natural justice inclusive of fairness are observed.”
She says the council has engaged with various parties on the criminalisation of medical errors. The HPCSA respects the laws of the country, Sekhonyana says, but she also notes that practitioners are starting to be discouraged from engaging in what may be perceived as risky procedures. “The HPCSA has had engagements with the National Prosecuting Authority on the matter and unfortunately, the situation has remained the same. However, should there be activities aimed at legal reform, the HPCSA will participate in that process and make its views known at that juncture,” she says.
Spotlight made several attempts to get comment from the National Department of Health on the criminalisation of medical errors. The department had not provided a response by the time of publishing.
On 13 April 2024,the South African Health Products Regulatory Authority (SAHPRA) initiated a precautionary recall of two batches of Benylin Paediatric Syrup (batch numbers 329303 and 329304), in response to reported high levels of diethylene glycol in an alert by the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC). The recall was implemented as a precaution to protect lives while SAHPRA investigated the reported high levels of diethylene glycol.
As the national regulatory authority for health products in South Africa, SAHPRA implements health product recalls as a crucial measure to address safety concerns or quality issues in the interest of public health.
As part of the investigation of the reported high levels of diethylene glycol, SAHPRA tested samples of the two affected batches of Benylin Paediatric syrup through an independent laboratory and a method developed by the World Health Organisation for testing products for the presence of diethylene glycol. The tests did not find traces of diethylene glycol in the recalled batches. This indicates that units of batches 329303 and 329304 that were stored at the required temperature would not contain unacceptable levels of diethylene glycol.
SAHPRA also wishes to indicate that there is no record of any adverse drug reactions relating to diethylene glycol for the two recalled batches in South Africa or anywhere else where they were exported to on the continent.
SAHPRA is mandated to regulate and apply due diligence to health products to ensure that products in circulation in South Africa and those exported from SAHPRA-licensed manufacturers are safe for public consumption. SAHPRA applies this due diligence throughout the product life cycle, from registration through to post-market monitoring.
“SAHPRA will continue to closely monitor medical products that have the potential of containing unacceptable levels of diethylene glycol. And we will continue to address safety concerns or quality issues so that the health of the public is protected,” says SAHPRA CEO, Dr Boitumelo Semete-Makokotlela.
