The practice of compounding (that is, the preparation, mixing, combining, packaging and labelling of a medicine by, amongst others, a pharmacist) [1] has attracted renewed attention and regulatory scrutiny, in light of the recent proliferation of compounded medicines containing GLP-1 [2] agonist active components in the South African market. GLP-1 agonists are a class of medicines directed at the treatment of type 2 diabetes and related cardiovascular conditions, as well as chronic weight management and obesity. [3]

The compounding of particular medicines for individual patients by a pharmacist is expressly contemplated in the Medicines and Related Substances Act[4] (“Medicines Act”), which regulates the manufacturing and supply of medicines in South Africa. Compounding is generally used in circumstances where mass-produced formulations of medicines are either unavailable or unsuitable for a particular patient.

In terms of section 14(1) of the Medicines Act, all medicines that are subject to registration, as determined by the South African Health Products Regulatory Authority (“SAHPRA”), are required to be registered in order to be lawfully imported, offered, advertised or sold in South Africa.

As a legal prerequisite to the registration of any medicine, SAHPRA must be satisfied that the medicine in question is, inter alia, suitable for the purpose for which it is intended, and is safe, efficacious and of good quality. [5]

Notably, the registration requirements in the Medicines Act include an explicit carve-out for compounded medicines in terms of section 14(4) of the Medicines Act. Four principal requirements, for the lawful sale of an (unregistered) compounded medicine emerge from section 14(4) of the Medicines Act, namely that –

• the medicine must be compounded for a particular patient in the specific quantity required for the treatment of that patient;
• the medicine must not contain any component which has been prohibited for sale in terms of the Medicines Act, or which SAHPRA has declined to register;
• the medicine must not be advertised; and
• the active components of the medicine must appear in another medicine which has been registered under the Medicines Act.

It is this last-mentioned requirement that the High Court, Pretoria, was called upon to interrogate and clarify in the recent decision of Novo Nordisk (Pty) Ltd v iDexis Compounding Specialists (Pty) Ltd t/a Sentrade Pharmacy and Four Others, [6] which was handed down on 22 June 2026 (“the iDexis decision”). The iDexis decision concerned the extent to which compounded medicines containing GLP-1 agonist active components may lawfully be advertised, offered and sold in South Africa.

The prevalence of these medicines in the South African market has not gone unnoticed by SAHPRA and the South African Pharmacy Council (“SAPC”), who, on 23 May 2026, announced that they would pursue “intensified enforcement action against the unlawful manufacturing and distribution of unregistered GLP-1 and [gastric inhibitory polypeptide] medicines”. [7]

It is against this background that Novo Nordisk Proprietary Limited (“Novo Nordisk”), being the authorised South African importer and distributor of registered medicines containing semaglutide (a GLP-1 agonist and Scheduled substance), branded as Ozempic and Wegovy, launched an application for an urgent interdict against iDexis Compounding Specialists Proprietary Limited (“iDexis”), and its sole shareholder and director.

Novo Nordisk sought to prevent iDexis and its shareholder/director from manufacturing and selling (unregistered) medicines containing semaglutide, on the basis that doing so contravened the Medicines Act, pending the outcome of an investigation by SAHPRA and the SAPC into their alleged illegal manufacture and sale of these medicines. iDexis, in turn, sought to argue that the compounding of medicines containing semaglutide is lawful, as Ozempic, which contains semaglutide, is a registered medicine in South Africa.

In deciding whether or not to grant the interim interdict, the court focused on what it regarded as the definitive issue in so far as the legality of iDexis’ activities was concerned, namely whether the active pharmaceutical ingredients (“APIs”) in Novo Nordisk’s and iDexis’ respective products were of such a nature that iDexis was lawfully permitted to compound its product by virtue of section 14(4) of the Medicines Act.

In doing so, Van Niekerk J undertook a detailed factual analysis of the API in Ozempic and Wegovy, as contrasted with the API in iDexis’ product, which originated from a source undisclosed by iDexis. Taking into account that the semaglutide developed and manufactured by Novo Nordisk Denmark is a biological product extracted from yeast, whilst the API in iDexis’ product is a synthetic peptide with a molecular structure similar (but not identical) to the Ozempic API, the court concluded that section 14(4) did not permit iDexis to compound medicines containing a synthetically produced semaglutide that had not been approved and registered with SAHPRA.

Interpreting section 14(4) in light of the purpose of the Medicines Act (being the regulation of medicines in the public interest), the court held that –

“… it is a matter of logic and common sense that the active component of a scheduled medicine, which requires a stringent registration process, can never be allowed into a medicine without the scrutiny of SAHPRA, and without the proper stringent screening process envisaged in terms of the Medicines Act and regulations, by relying on “similarity” subjectively determined, under the guise of compounding in terms of section 14(4)”. [8]

iDexis’ compounding of medicine containing synthetically produced semaglutide was, therefore, found to be unlawful. Turning to the relief sought, the court found that the requirements for an interim interdict had been met, holding in particular that, where it appears conduct may be contrary to the Medicines Act, such conduct should not be permitted to continue unabated, particularly where the ongoing illegality is also a criminal offence (as in this case).

The iDexis decision now provides helpful legal clarity on the interpretation of section 14(4) of the Medicines Act and the ambit of lawful compounding, as contemplated in this section.

Pharmacists and licensed pharmacies would be well advised to take note of the decision and seek the appropriate legal advice to ensure that their compounding activities align with the applicable statutory framework. The interim nature of the relief granted in the iDexis decision, the court’s limited focus in deciding the matter, and the far-reaching impact of the matters canvassed in the judgment, however, signal that the debate surrounding lawful compounding, particularly in so far as it pertains to medicines containing GLP-1 agonists, is far from settled.

[1]        The General Regulations published in terms of the Medicines Act, under GN 859 in GG 41064 of 25 August 2017, define “compound” as “the preparation, mixing, combining, packaging and labelling of a medicine (a) by a pharmacist practising in accordance with the Pharmacy Act, 1974; (b) by a veterinarian practising in accordance with the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982); or (c) by a person licensed in terms of section 22C(1)(a) of the Act and practising in accordance with their scope of practice”.

[2]        Glucagon-like peptide-1.

[3]        See paragraph 13 of the iDexis decision.

[4]        No. 101 of 1965.

[5]        Section 15(3) of the Medicines Act.

[6]        Case number 2024-130119.

[7]        Media Release published by SAHPRA and the SAPC, entitled “SAHPRA and the SAPC Crack Down on Unlawful Manufacturing of Unregistered GLP-1/GIP Medicines” and dated 23 May 2026.

[8]        Paragraph 64 of the iDexis decision.

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On 18 May 2026, the Constitutional Court (“CC”) in Solidarity Trade Union and Others v Minister of Health and Others [1] confirmed the invalidity of the Certificate of Need (“CoN”) provisions contained in sections 36 to 40 of the National Health Act [2] (“NHA”).

The CC found that the CoN provisions were irrational and unjustifiably limited the right to choose a trade, occupation or profession freely. The CC’s invalidity confirmation has prompted closer examination of the role that the concept of “need” plays within South Africa’s healthcare legislative framework.

Such examination is warranted because the CoN provisions incorporated considerations of need into the regulatory framework governing whether or not and where healthcare service providers could establish, construct, modify or acquire health establishments or provide prescribed health services. [3] The CC’s judgment therefore brought an end to a legislative scheme in which an assessment of need formed part of the criteria determining whether or not and where healthcare service providers could establish, construct, modify or acquire health establishments or even provide prescribed health services.

In terms of the CoN scheme, healthcare service providers were required to obtain approval from the Director General of the National Department of Health (“Director General”) before establishing, constructing, modifying or acquiring health establishments or providing prescribed health services. In determining whether or not to grant such an approval, the Director General was required to consider various factors, including, amongst others, the need to promote the equitable distribution and rationalisation of healthcare services and resources, address inequities based on racial, gender, economic and geographical considerations, and promote an appropriate mix of public and private healthcare services. [4] Accordingly, the concept of “need” formed an integral part of the considerations informing the Director General’s decision whether or not to grant or refuse a CoN application.

Following the CC’s judgment, questions naturally arose regarding whether or not, and to what extent, similar considerations of need continue to feature in other healthcare legislation.

In particular, the incorporation of the concept of “need” in the National Health Insurance Act [5] (“NHI Act”) raises important questions regarding how that concept ought to be interpreted and implemented so as to avoid the constitutional difficulties that resulted in the invalidation of the CoN provisions. Although the NHI Act does not establish a CoN regime and does not require healthcare service providers to obtain prior approval in order to operate, references to “need” feature prominently throughout the NHI Act’s currently proposed purchasing, contracting and accreditation framework. In particular –

• the Fund is required to actively and strategically purchase healthcare services on behalf of users in accordance with need [6];

• the Fund must enter into contracts with accredited healthcare service providers and health establishments based on the health needs of users [7];
• healthcare service providers and health establishments, seeking accreditation, must demonstrate that they meet the needs of users and comply with prescribed performance criteria [8]; and
• the Fund may conclude legally binding contracts only with health establishments and prescribed healthcare service providers that satisfy the applicable accreditation requirements. [9]

Accordingly, whilst healthcare service providers remain free to operate in the absence of accreditation, participation in the provision of Fund-funded healthcare services is dependent upon satisfying the requirements prescribed by section 39(2) of the NHI Act.

Given that the Fund is to be the single purchaser of healthcare services covered under the NHI framework, the inability to obtain accreditation may substantially affect a healthcare service provider’s ability to render Fund-funded services and, consequently, to participate effectively in that segment of the healthcare market. In this respect, the practical implications of accreditation under the NHI Act warrant consideration alongside the concerns identified by the CC regarding the use of regulatory mechanisms that may limit the extent to which healthcare service providers are able to exercise their right to choose a trade, occupation or profession freely.

It is therefore necessary to consider the role that “need” plays within the NHI Act and, concomitantly, whether the CC’s treatment of the concept of “need”, in the context of the CoN scheme, now provides any insight into how the concept of “need” should be interpreted and applied under the NHI accreditation framework.

Applying the principles of statutory interpretation, the phrase “needs of users” must be interpreted in accordance with its ordinary grammatical meaning, read in context and having regard to the purpose of the NHI Act. [10]

Ordinarily, the phrase “needs of users” may be understood as referring to the healthcare requirements of persons entitled to receive healthcare services funded by the Fund. In this regard, the NHI Act seeks to achieve universal access to quality healthcare services through the strategic purchasing of healthcare services by the Fund based on the health needs of users. Viewed in this context, the reference to need within the NHI Act appears directed towards ensuring that healthcare services purchased by the Fund correspond with the healthcare requirements of the population served by the Fund.

Nevertheless, the NHI Act does not define what constitutes the “needs of users” nor does it prescribe the criteria against which those needs are to be assessed. The absence of specific statutory guidance regarding the factors relevant to determining whether or not a particular healthcare service provider meets the needs of users may afford the Fund a measure of discretion in the accreditation process.

There are, however, important distinctions between the two regimes: the CoN scheme directly restricted the ability of healthcare service providers to establish, acquire or modify health establishments in the absence of administrative approval but, by contrast, the NHI Act does not prohibit healthcare service providers from operating without accreditation. Instead, the NHI Act regulates participation in the provision of healthcare services financed by the Fund.

The constitutional significance of the CoN judgment therefore lies not merely in the invalidation of the CoN scheme itself, but in the caution that judgment provides against the future interpretation and implementation of healthcare legislative provisions, which incorporate considerations of “need” in a manner capable of affecting the exercise or limitation of constitutional rights.

Notwithstanding these differences, both frameworks incorporate considerations of need into administrative decision-making processes that influence the extent to which healthcare service providers may participate in the delivery of publicly funded healthcare services. To this limited extent, the CC’s reasoning in the CoN judgment remains relevant to discussions concerning the implementation of the NHI Act. More specifically, the CC’s judgment illustrates that, notwithstanding the legitimacy and importance of the public health objectives pursued by the CoN scheme, legislative measures designed to achieve those objectives must bear a rational connection to their stated purpose. In the absence of such a rational connection, those legislative measures are susceptible to constitutional challenge and may be declared legally invalid. [11]

The invalidation confirmation of the CoN provisions by the CC should serve as a cautionary reminder when considering the role of “need” within the NHI framework.

Although the NHI accreditation framework differs from the CoN scheme in several respects, the incorporation of “need” into the Fund’s purchasing, contracting and accreditation functions warrants careful scrutiny as and when the framework is implemented in practice. Particular care should, therefore, be taken to ensure that the interpretation and application of the “needs of users” requirement do not produce outcomes that replicate the constitutional defects identified by the CC in the CoN scheme.

Accordingly, the implementation of the NHI Act must be accompanied by clear criteria, rational decision-making processes and appropriate procedural safeguards to ensure that the operation of the “need” requirement does not produce outcomes analogous to those that led to the invalidation of the CoN scheme.

[1] [2026] ZACC 19 (18 May 2026).

[2] No. 61 of 2003.

[3] Section 36(3) of the National Health Act.

[4] Solidarity Trade Union and Others v Minister of Health and Others [2026] ZACC 19 (18 May 2026) at paragraph 3.

[5] No. 20 of 2023.

[6] Section 35(1) of the National Health Insurance Act.

[7] Section 7(2)(e) of the National Health Insurance Act.

[8] Section 39(2)(c) of the National Health Insurance Act.

[9] Section 39(3) of the National Health Insurance Act.

[10] Natal Joint Municipal Pension Fund v Endumeni Municipality 2012 (4) SA 593 (SCA) at paragraph 17.

[11] Solidarity Trade Union and Others v Minister of Health and Others [2026] ZACC 19 (18 May 2026) at paragraphs 57 and 78.

The post The Concept of “Need” in South Africa’s Healthcare Framework: From Certificates of Need to National Health Insurance Accreditation appeared first on Werksmans Attorneys.

Event Details:

Date: 21 May 2026

Location: Werksmans Attorneys, 96 Rivonia Road, Sandton, Johannesburg

Seminar Time: 15h30 for 16h00 | Networking: 17h30 onwards

Kindly RSVP by 14 May 2026.

Agenda:

16:00 – 16:05 | Opening and Overview

Neil Kirby, Director and Head of Healthcare & Life Sciences, Werksmans Attorneys

16:05 – 16:20 | An update on the current status of NHI litigation: Substantive legal challenges to the provisions of the legislation: common themes

Helen Michael, Director, Werksmans Attorneys

16:20 – 17:05 | What now? The implications of the aftermath of NHI litigation: Public Participation Challenges before the Constitutional Court

Siphosakhe Phakathi, Senior Associate, Werksmans Attorneys

17:05 – 17:30 | What Health Funders can do now to advance Universal Health Coverage

Charlton Murove, Head of Research at Board of Healthcare Funders

17:30 – 17:40 | Questions & Discussion

To book your seat, please RSVP here.

We look forward to hosting you.

The post Exclusive CPD Accredited Seminar: The Current Status of Litigation Dealing with the National Insurance Scheme appeared first on Werksmans Attorneys.

The present dire state of public healthcare in the Gauteng Province has been widely publicised, with access to treatment being a central theme. In terms of section 27 of the Constitution of the Republic of South Africa, 1996 (Constitution), all persons have a right to access healthcare services, and the State is obliged to take reasonable legislative and other measures, within its available resources, to achieve the progressive realisation of this right. In other words, the State must take reasonable steps, within its available resources, to expand access to healthcare over time.

However, barriers to access in public healthcare facilities are rife, giving rise to two notable recent legal challenges in Gauteng. In both of these cases, the applicants sought to compel the State to take certain steps to protect and promote section 27 rights by way of positive (mandatory and structural) interdicts.

In particular, and just over a year ago, on 27 March 2025, the Gauteng Local Division of the High Court, Johannesburg, in Cancer Alliance v Member of Executive Council for Health Gauteng Province and Others^[1] (Cancer Alliance), granted an order which required the Gauteng Department of Health (GDoH) to devise and implement a plan to provide radiation oncology services to cancer patients on a backlog list at two Gauteng hospitals. Following the court order, however, and despite initial optimism regarding the impact of the ruling, the Supreme Court of Appeal (SCA) subsequently granted the GDoH leave to appeal the High Court’s decision. As a result, the execution of the judgement and order in Cancer Alliance has been suspended pending the outcome of the appeal – an issue which itself became the subject of extensive legal debate between the parties.[2]

Another recent instance in which the the Gauteng Division of the High Court, Johannesburg, was called upon to enforce the State’s obligation to facilitate access to healthcare, by way of a positive interdict, was in the matter of Treatment Action Campaign and Others v Facility Manager, Yeoville Clinic and Others[3] (TAC v Facility Manager). This matter, which was decided on 4 December 2025, arose as a result of the recent trend of vigilante groups blocking access to public clinics in the Johannesburg inner city by anyone not in possession of a valid South African identity document. The applicants in the matter sought an interdict compelling the provincial health authorities to develop and implement measures to prevent these groups from blocking access to the relevant clinics. This interim interdict was sought pending an application for a final order directing that the aforementioned measures be put in place throughout Gauteng.

In its decision, the court found that both the provincial health authorities and the South African Police Service (SAPS) had neglected to take action against the vigilante groups and to remove barriers to entry at the clinics. As a result, the court concluded that the authorities were failing in their constitutional and statutory duties.

Remarkably, the provincial health authorities argued that they had completely outsourced their constitutional and statutory responsibilities in respect of the relevant clinics to the City of Johannesburg (CoJ). The court, however, found that the service level agreement on which the authorities had sought to rely in this regard in fact provided for co-operation between the GDoH and the CoJ, and (as one would expect) did not permit the authorities simply to abrogate their responsibilities to promote access to healthcare in the province – responsibilities which arise from both section 27 of the Constitution and section 3 of the National Health Act No. 61 of 2003.[4]

As a result, the court found that the requirements for an interim interdict were met in the circumstances.[5] Ultimately, therefore, the court found that it was under a duty to grant effective relief to the applicants, and persons seeking access to the inner-city clinics, in order to remedy the State’s shortcomings. The court, accordingly, ordered the provincial health authorities and SAPS to –

• take reasonable measures to ensure safe, unhindered access to the clinics;
• remove unauthorised persons obstructing access to the relevant clinics;
• station trained security personnel at access points to the clinics; and
• file a report with the court, within 10 court days of the order, setting out the actions taken to comply with the order.

The SAPS were, in turn, ordered to provide all necessary assistance to the clinics to ensure compliance with the order.

The Cancer Alliance and TAC v Facility Manager decisions demonstrate that mandatory and structural interdicts have the potential (when implemented) to be effective tools for safeguarding and enforcing the constitutional right to access to healthcare. In both cases, the courts recognised that where the State fails to take reasonable steps to fulfil its constitutional obligations, judicial intervention may be necessary to compel action. In both matters, the interdicts required the State to implement concrete measures to ensure access to healthcare. In this way, mandatory interdicts serve as a practical tool to transform the right to access to healthcare into tangible outcomes for vulnerable individuals who depend on the public healthcare system.

Whilst the developments in Cancer Alliance highlight some of the limitations of mandatory interdicts in compelling urgent state action (particularly in circumstances involving acute healthcare needs), the courts’ willingness to grant positive interdicts in these recent cases nevertheless demonstrates a broader judicial obligation to ensure that the State’s constitutional duty to provide access to healthcare is not rendered meaningless by administrative inaction.

[1]        2025 ZAGPJHC 136 (27 March 2025).

[2]        In this regard, on 5 August 2025, Cancer Alliance lodged an urgent application, in terms of section 18 of the Superior Courts Act No. 10 of 2013, seeking an order that the High Court’s decision in Cancer Alliance was interim in nature and, therefore, should remain operational and enforceable against the GDoH. This argument proved successful before Dippenaar J on 20 August 2025. The judgement was, however, appealed by the GDoH and ultimately overturned on 5 December 2025 by a full bench of the High Court. In its decision, the appeal court found that Dippenaar J inter alia –

• failed to deal meaningfully with the requirement to consider the prospects of success of the GDoH’s pending appeal;
• erred in finding that the patients on the backlog list would suffer irreparable harm if the order was not granted; and
• erred in finding that the GDoH would not suffer irreparable harm if the decision were to be made immediately enforceable notwithstanding the pending appeal.

[3]        2025 ZAGPJHC 1256 (4 December 2025).

[4]       The court further held that the SAPS was failing in its duties under section 205(3) of the Constitution to prevent crime and secure law and order, which required that the police play an active role in crime prevention beyond merely receiving and acting on complaints from the public – which the SAPS argued was the full extent of its responsibility in respect of the blockading of clinics by the vigilante groups.

[5]        The court granted the interim interdict on the basis that –

• persons seeking healthcare services at the relevant inner-city clinics had a clear prima facie right to the final relief sought, which derived from the Constitution and statute;
• the harm posed by the vigilante groups to persons seeking healthcare services at the clinics was severe and ongoing;
• the balance of convenience favoured the applicants, as the provincial health authorities and SAPS did not argue that they were unable to address the harm but simply (and, according to the court, incorrectly) that they were under no obligation to do so; and
• the only suggested remedial alternative to the interdict sought – that is, reporting unlawful activity to the police – had not been successful.

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On 21 November 2025, the Health Professions Council of South Africa (“HPCSA”) published Board Notice 856 of 2025 (“BN 856”), which significantly amends rule 18 of the Ethical Rules of Conduct for Practitioners Registered Under the Health Professions Act No. 56 of 1974, published under GN R717 in GG 29079 of 4 August 2006 (“Ethical Rules”).

Rule 18 of the Ethical Rules governs the conditions under which a registered practitioner may accept a professional appointment or employment by a non-registered person, such as a private company.

Although the amended rule 18 is unfortunately brief, the shift it introduces is material. The amended rule alters the requirements for employment relationships between practitioners and non-registered healthcare enterprises.

The amendment of rule 18 also has the potential to cause severe prejudice to those entities and practitioners who structured their operations based on the provisions of rule 18, which were in force prior to the 2025 amendment.

The amended rule 18, as published in BN 856, provides as follows –

“A practitioner shall accept a professional appointment or employment from employers approved by the [HPCSA] only in accordance with a written contract of appointment or employment which is drawn up on a basis which is in the interest of the public and the profession.”

The pre-approval requirement for such appointments and employment relationships is not new. The HPCSA’s approval was historically required in order for non-registered entities to appoint or employ registered persons. However, an amendment which took effect on 17 November 2023 changed the position dramatically, and permitted practitioners to “accept a professional appointment or employment from employers in accordance with a written contract of appointment or employment which is drawn up on a basis which is in the interest of the public and the profession”. This was subject to the proviso that “the health practitioner ensures that the employment contract has as its primary aim the enhancement of the quality of health-care services to patients, is structured to contain costs, enhance access to appropriate, high quality health-care services or products to patients, and is not designed to extract profit for the benefit of the practitioner or their employer to the detriment of patients”.

Therefore, during the approximately two-year period between 17 November 2023 and 21 November 2025 (“the Interim Period”), non-registered entities such as private companies were lawfully permitted to employ registered practitioners without the HPCSA’s approval, provided that the appointment or employment was in accordance with a written contract drawn up on a basis which was in the interest of the public and the profession. Several such entities, accordingly, proceeded on this basis, relying on the HPCSA’s stated position that applications for approval were not required – and would not be considered.

The now amended rule 18 reintroduces the pre-approval requirement for non-registered entities to employ registered practitioners. This has the potential severely to impact business structures involving non-registered entities, which had become viable during the Interim Period. The question, accordingly, arises as to what the impact of the amended rule 18 will be on healthcare enterprises which lawfully contracted with registered practitioners during the Interim Period without the HPCSA’s approval.

In this regard, the amended rule 18 does not state that it operates retrospectively. The well-established principle of legality and the rule of law, which is a founding value of the Constitution of the Republic of South Africa, 1996, arguably militate against retrospective application of the rule. In this regard, the Constitutional Court has recognised that non‑retrospectivity of the law is a tenet of the principle of legality, and “[e]veryone deserves protection from retroactivity of the law where the result of retroactivity would be prejudicial” to any person or group of persons.[1]. That court has also held that the rule of law “embraces some internal qualities of all public law: that it should be certain, that is ascertainable in advance so as to be predictable and not retrospective in its operation”.[2]

The principle of legality also underpins the common-law presumption that statutes, which would include amended rule 18, do not apply retrospectively, and that retrospective interference with vested rights acquired under existing laws, or the creation of new obligations and the imposition of new duties by the legislature in regard to past events, should not be lightly assumed.[3]. The retrospective application of the amended rule 18 would be manifestly prejudicial to entities and practitioners who structured their affairs in a manner which complied with the Ethical Rules during the Interim Period.

Should the HPCSA nevertheless adopt the view that the amended rule 18 applies retrospectively, granting entities, which lawfully employed registered persons during the Interim Period, a reasonable grace period within which to regularise their employment relationships – alternatively, creating a dispensation for the recognition of existing employment relationships in line with the applicable labour and employment laws – would go a long way to minimise such prejudice. The HPCSA has, however, to date, not provided any guidance as to the way forward for the now affected practitioners and entities.

The latest amendment to rule 18 marks a decisive reversion toward tighter regulatory oversight of practitioners’ employment, and, again, places the HPCSA at the centre of decision-making regarding who may employ practitioners and under what contractual terms.

Regardless of the lack of clarity regarding retrospective application and existing employment relationships, it may reasonably be assumed that non-registered employers who have not yet received the requisite approval from the HPCSA should commence taking steps to submit the necessary application to the HPCSA for the approval of any intended employment relationships to avoid adverse regulatory consequences.

[1]       Phaahla v Minister of Justice and Correctional Services and Another 2019 (2) SACR 88 (CC) at paragraph 49.

[2]       Pharmaceutical Manufacturers Association of South Africa and Another: In re Ex Parte President of the Republic of South Africa and Others 2000 (2) SA 674 (CC) at paragraph 39.

[3]       Kaknis v Absa Bank Ltd and Another 2017 (4) SA 17 (SCA) at paragraph 12.

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Artificial intelligence (“AI“) is reshaping industries worldwide, and healthcare is no exception. The healthcare sector in South Africa experiences limited resources, staff shortages, and unequal access – however, AI presents an opportunity to enhance care delivery, improve diagnostic accuracy, and support overburdened healthcare professionals. From virtual assistants to predictive analytics, AI is redefining how medical diagnoses are made, care is provided, and clinical decisions are supported. Yet, with great innovation comes great responsibility. As AI becomes increasingly embedded in clinical practice, concerns around reliability, ethics, accountability, and regulation become more pressing. When deployed with the right safeguards, AI has the potential to deliver safer, more efficient, sustainable and accessible healthcare to communities across the country. This article explores how AI can be responsibly integrated into the South African healthcare system, focusing on its role in diagnostics, decision-making and sustainability, while outlining the ethical, legal, and practical guardrails essential to its safe and equitable use.

Although there have been various use cases of AI in the healthcare sector,[1] a study published late in 2024 by Beth Israel Deaconess Medical Centre in Boston, Massachusetts, compared the diagnostic performance of ChatGPT-4 (“ChatGPT“) with that of practicing physicians.[2] The results of the study found that ChatGPT achieved a 90% accuracy rate in diagnosing case reports, while physicians who were randomly assigned to use ChatGPT in conjunction with their traditional clinical diagnostic methods scored 76%, whereas those physicians who did not make use of ChatGPT at all scored 74%. While the study highlights AI’s ability to enhance clinical decision-making, it also exposes the challenges of implementing AI in the healthcare sector. When presented with AI-generated insights, many physicians in the study were reluctant to revise their initial diagnoses, highlighting the cognitive biases and trust barriers that can arise in human-AI collaboration. The study reflects both the promise and complexity of using AI in healthcare: successful implementation depends not only on performance, but also on trust, transparency, and clinical judgment. Even though the study did not specifically consider the sustainability aspects of incorporating AI in the healthcare in a responsible manner, the World Economic Forum (“WEF“), in its article entitled ‘The energy paradox in healthcare: How to balance innovation with sustainability‘[3], highlights that if global healthcare was currently a nation, it would be ranked as the fifth largest emitter of greenhouse gases, globally. While WEF recognises that training large AI models, such as ChatGPT, consumes significant amounts of electricity if not adequately managed, it notes that task-specific AI models (i.e. narrow AI), which requires less computational power, could provide the best benefits, being enhanced patient outcomes (as indicated in the study) while minimising the adverse environmental impacts of AI.

In South Africa, AI integration must be guided by existing legal and ethical frameworks and adapted to the country’s unique healthcare context. While there are no AI-specific regulations as yet, the Health Professions Council of South Africa (“HPCSA“) provides essential ethical standards through, inter alia, its General Ethical Guidelines for Healthcare Professionals and, in particular, the General Ethical Guidelines for Good Practice in Telehealth. These ethical guidelines underscore the importance of patient autonomy, informed consent, practitioner accountability and upholding confidentiality – principles that equally apply when AI tools are used. For instance, consistent with general ethical principles such as informed consent and practitioner accountability, patients should be informed when AI assists in their care, and clinicians must retain full responsibility for final decisions, even though current HPCSA guidelines do not yet explicitly address the use of AI tools in clinical care. Compliance with the provisions of the Protection of Personal Information Act 4 of 2013 (“POPIA“) and the National Health Act 61 of 2003 (“NHA“) is also essential to ensure lawful processing of health data.

The HPCSA’s guidelines on telehealth do not currently make provision for or substantively address the use of AI in clinical diagnostics.[4] The existing guidelines remain anchored in an outdated telemedicine framework that assumes a face-to-face consultation and a physical examination by a registered practitioner is essential to ethical care. This model does not contemplate the semi-autonomous or autonomous role that AI tools are increasingly playing in diagnostic processes. As a result, there is no regulatory clarity on whether or how AI can be lawfully and ethically integrated into clinical decision-making. This gap is compounded by the fact that South African law does not recognise AI systems as legal actors, meaning they cannot function as “servicing practitioners” in partnership with practising clinicians.

This omission is not merely theoretical: it threatens to stifle innovation and limit the benefits that AI can offer in improving access to care and clinical accuracy. The guidelines, as they stand, may also be inconsistent with national digital health policy, which promotes technological innovation as a strategic imperative. To close this gap, the HPCSA’s ethical guidelines would need to be amended to explicitly permit the use of AI, and to provide guidance on key concerns such as informed consent, accountability, liability, and transparency in AI-assisted care. These reforms are not just desirable, they are necessary. A key issue that arises, however, is that the current common law framework of fault-based medical negligence may be ill-equipped to address harm arising from complex AI systems where no clear human error is traceable, leaving both patients and practitioners exposed to unacceptable legal uncertainty.

Contextual relevance is equally critical. Many popular AI health models are trained on datasets from high-income countries, limiting their accuracy in South African settings with different health trends, resource constraints, and systemic challenges. To ensure clinical value, these tools must be validated, or even retrained on local data. Without localisation, there is a risk of bias or inaccuracy, particularly in a healthcare landscape already marked by inequality. This applies not only to diagnostic tools but also to AI’s growing role in public health surveillance, predictive analytics, and telemedicine. In these spaces, AI-powered chatbots and triage tools are increasingly used to guide patients, recommend next steps, and help manage care, particularly where access to clinicians is limited.

Encouragingly, South Africa is not merely a passive consumer of global AI innovations, it is actively shaping its own. Local platforms like the SA Doctors App are pioneering the integration of AI-driven chatbots into telemedicine services, offering patients accessible, real-time support for triage, symptom checking, and appointment scheduling.[5] These tools are already improving early engagement and streamlining care, particularly in rural and underserved communities. South African institutions are also developing proprietary algorithms trained on local clinical trial data, reflecting a growing commitment to building AI solutions that are not only innovative but also contextually relevant. These developments signal a shift toward a more confident, proactive approach to digital health, one that embraces AI as a tool for expanding access, enhancing quality, and reimagining the future of care.

This shift toward AI-integrated healthcare must be accompanied by clear operational, ethical, and regulatory guardrails. At a minimum, these should include –

• Human oversight and accountability: AI must support, not replace, clinical judgment;
• Local validation and transparency: AI systems must be tested on South African data and provide outputs that clinicians can understand and act on;
• Data Protection Compliance: Any AI application processing personal health information must comply with the POPIA and NHA, ensuring that all data handling practices meet legal and ethical standards;
• Informed Consent: Patients must be clearly informed about how their personal health data is collected, used, stored, and protected, and must provide explicit consent before any data processing occurs; and
• Equitable access and inclusivity: AI should close, not widen, healthcare gaps, particularly between public and private sectors, or urban and rural communities.

As AI continues to evolve, its integration into South African healthcare must be grounded in the broader goals of equity, safety, sustainability, and quality care. AI holds significant promise in public health surveillance, early outbreak detection, personalised treatment planning, and chronic disease management, offering new tools to strengthen healthcare delivery. Realising this potential will require coordinated effort: policymakers must create clear regulatory pathways, healthcare institutions must invest in infrastructure, training, and oversight and developers must prioritise ethical design and contextual relevance. The Beth Israel study affirms AI’s value in diagnosis, but also underscores the importance of trust, transparency, and human judgment in its application. With robust safeguards, local validation, and patient-centred implementation, South Africa is well-positioned to harness AI not just as a technological advancement, but as a strategic tool for building a more inclusive, effective, sustainable, and resilient healthcare system.

[1]  Ankit Vora, ‘6 Applications of AI for Doctors + Real-Life Case Studies’ published on 17 January 2025, available on https://www.getfreed.ai/resources/ai-for-doctors#:~:text=It’s%20shown%20exceptional%20accuracy%2C%20outperforming,treatment%20for%20potential%20cancer%20cases. (accessed on 2 June 2025)

[2]   Gina Kolata, ‘A.I. Chatbots Defeated Doctors at Diagnosing Illness’ published on 17 November 2024, available on https://www.nytimes.com/2024/11/17/health/chatgpt-ai-doctors-diagnosis.html (accessed on 2 June 2025)

[3]   World Economic Forum, ‘The energy paradox in healthcare: How to balance innovation with sustainability’ published on 20 January 2025, available on https://www.weforum.org/stories/2025/01/the-energy-paradox-in-healthcare-how-to-balance-innovation-with-sustainability/#:~:text=Optimizing%20energy%20use%20in%20healthcare,by%20the%20AI%20systems%20themselves. (accessed on 15 May 2025)

[4]   Dusty-Lee Donnelly, ‘First Do No Harm: Legal Principles Regulating the Future of Artificial Intelligence in Health Care in South Africa’ published on 7 April 2022, available on https://perjournal.co.za/article/view/11118. (accessed on 17 June 2025).

[5]   Sphe Nhleko, ‘ The Rise of AI-Powered Diagnostics: Transforming South African Healthcare One Scan at a Time’ published on 23 January 2025, available on https://www.sadoctorsapp.co.za/Article?Article_Ref=15. (accessed on 17 June 2025).

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Read more about our Healthcare & Life Sciences practice area.

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1. The tragedy which occurred in Stilfontein earlier this year (“the Stilfontein tragedy”) has uncovered important legal questions concerning the obligations of mining right holders in circumstances where illegal miners are trapped in a mine which is no longer being worked but where no closure certificate has been issued

2. The Stilfontein tragedy involved hundreds of illegal miners who unlawfully entered the shaft of a non-operational goldmine and became trapped whilst conducting illegal mining operations. It led to at least 78 deaths and necessitated an extraction operation that rescued more than 240 illegal miners. The rescue operation was conducted by Mine Rescue Services over the course of four days and cost millions of Rand. The question of who should carry these costs was vexed, with all government stakeholders denying financial liability. This sparked a debate within the industry about which parties bear statutory obligations in these circumstances.

3. Within the South African mining landscape, illegal mining continues to be a serious problem, and whilst the Stilfontein tragedy happened to catch the attention of the media, its facts are not unique. This notwithstanding, there is no case law dealing with what a mining right holder’s responsibilities are in such instances. However, earlier this year, the leading commentary on the Mine Health and Safety Act 29 of 1996 (“the MHSA”), Willem Le Roux’s Mine Health and Safety Law, updated the relevant portion of its chapter dealing with this aspect of the MHSA. This offers some guidance. Section 2(2) of the MHSA provides that –

“The employer of every mine that is not being worked, but in respect of which a closure certificate […] has not been issued, must take reasonable steps to continuously prevent injuries, ill-health, loss of life or damage of any kind from occurring at or because of the mine“.

4. At the outset, it is important to understand the meaning of the word “work” and the words “being worked“, given that the MHSA does not define either. This lacuna in the legislation, and the lack of authority on this point necessitate that we apply the rules of statutory interpretation to understand what the MHSA means when it employs these words – which must be interpreted in the context of the statute as a whole.

4.1. In section 102 of the MHSA, when used as a noun, the word “mine” is defined as –

“any borehole, or excavation […] made for the purpose of searching for or winning a mineral, whether it is being worked or not …”

4.2. In relation to a “mine“, the word “owner” is defined as “the last person who worked the mine or that person’s successor in title“.

4.3. The verb “work” must be read in conjunction with the word “owner” and the activities mentioned in paragraphs (a) and (b) of the word “mine“.

5. As an example of its deployment in the MHSA, the mere pumping of water without the inclusion of any other listed activity does not constitute the “working” of a “mine“.

6. Additionally, we can only determine the standard of care required of a mining right holder once a mine is classified as being worked or not being worked – given the vast difference between these two positions.

7. Section 2(1) of the MHSA provides that the employer of a mine that is being worked is under a duty to –

“ensure as far as reasonably practicable that the mine is designed, constructed and equipped —

(i) to provide conditions for safe operation and a healthy working environment; and

(ii) with a communication system and with electrical, mechanical and other equipment as necessary to achieve those conditions.”

8. In terms of the MHSA, the requirement that health and safety measures be taken “as far as reasonably practicable” typically includes the obligation on the part of the mining right holder to “maintain a healthy and safe mining environment”, “ensure an adequate supply of health and safety equipment” and “assess and respond to risk“. These obligations are extensive and have been amplified by means of regulations because a working mine requires such measures to prevent or mitigate the hazards caused by mining activities.

9. However, in respect of a mine that is not being worked, the standard of care is less stringent. The threshold is reduced from what is “reasonably practicable“, as required by section 2(1), to the standard of “reasonableness” referenced in section 2(2). “Reasonableness” simply describes the care that “can be expected of a reasonable person“. For a mine that is not being worked, this only requires that the mining right holder take ‘reasonable‘ steps insofar as health and safety are concerned. The extent of these steps is determined with reference to the factual circumstances of each mine.

10. The difference between these provisions is demonstrated by the Mine Health and Safety Regulations (GNR.93 of 15 January 1997) (“the Regulations“). For example, Regulation 16.5 provides that where there are 100 or more people underground, the mine’s employer is required to “provide and maintain […] mine rescue teams” which are “readily available“. A plain reading of this regulation reinforces the position that a non-operational mine in rehabilitation (which is not being worked) would not trigger the obligation in that it should not have any “number of persons […] underground“, let alone the 100 required for the obligation to arise. The need to maintain a mine rescue team is exactly the kind of requirement that the employer of a mine which is “being worked” would incur, given the requirement that the employer be appropriately poised to “respond to risk“.

11. In conclusion, the extent of a mining right holder’s legal obligations becomes limited once a mine is no longer “being worked“. In such circumstances, the mining right holder is only required to absorb the costs associated with taking those steps that a reasonable person would to maintain the health and safety standards of the mine – and not to “ensure, as far as reasonably practicable” that the mine is maintained to the standards required to safely accommodate its employees. The application of this provision could not have been intended to extend to cover the costs associated with the extraction of hundreds of illegal miners who became trapped after unlawfully entering the shafts of a gold mine that had not been worked for more than a decade.

Read more about our Mining & Resources practice area.

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On 27 March 2025, the Gauteng Local Division of the High Court, Johannesburg, granted urgent interim relief in the matter of Cancer Alliance v Member of Executive Council for Health Gauteng Province and Others 2025 ZAGPJHC 136 (27 March 2025) (“the Cancer Alliance matter”), ordering the Gauteng Department of Health (“GDoH”) to devise and implement a plan to provide radiation oncology services to cancer patients on a backlog list at two Gauteng hospitals.

Issues

The main issue before the court concerned the GDoH’s constitutional obligation to provide healthcare services, particularly radiation oncology treatment, to cancer patients. Cancer Alliance, being a collective group of cancer control non-profit organisations and advocates, argued that the GDoH had failed to utilise the sum of R784 million that had been allocated to it by the Gauteng Provincial Treasury in March 2023 to address the backlog in surgical and radiation oncology services. Of this amount, R250 million was allocated to the outsourcing of radiation oncology services. Despite this allocation, the GDoH did not devise or implement a plan to provide these services, leading to the return of the unspent R250 million to the Gauteng Provincial Treasury at the end of the fiscal year.

According to Cancer Alliance, the GDoH’s failure to provide timely radiation oncology services violated the following sections of the Constitution[1] –

• section 7(2), which mandates the State to respect, protect, promote, and fulfil the rights enshrined in the Bill of Rights;

• section 27, which provides that everyone has the right to have access to health care services, and requires the State to take reasonable measures progressively to realise this right and ensure no one is denied emergency medical treatment;

• section 33, which guarantees the right to just administrative action that is lawful, reasonable, and procedurally fair; and

• section 195(1), which outlines principles for public administration, including the efficient use of resources, responsiveness to people’s needs, public participation in policymaking, and fostering transparency through timely and accurate information.

Judgment and order

In deciding to grant the interim relief sought, the court found that the need for urgent redress had become clear from the circumstances of the case, in which patients on the backlog list had been “deprived of radiation oncological treatment for so long that repeated surgeries and repeated chemotherapy virtually became routine and early death at times became inevitable“.[2] The court considered the impact of the GDoH’s conduct on the patients’ constitutional rights and found that the GDoH, without justifiable reason, ignored the patients’ right to receive outsourced radiation oncology treatment, which flowed from the ring-fenced funds that had been made available for that specific purpose.

The GDoH was also found to have ignored Cancer Alliance’s attempts to persuade it to communicate with Cancer Alliance regarding the tender process, and to follow a deviation process in terms of the Treasury Regulations to procure the requisite radiation oncology services. In so doing, the court held that the GDoH infringed the patients’ and Cancer Alliance’s rights under section 195 of the Constitution. Van Nieuwenhuizen AJ criticised the GDoH for its lack of accountability and transparency in handling the allocated funds, finding that “a high standard of professional ethics [was] not maintained, efficient, economic and effective use of resources [was] not promoted, services were not provided impartially, fairly, equitably and without bias and  [patients’] needs were not responded to…”.[3]

On the basis that patients on the backlog list face life-threatening illness which, in the absence of treatment, would lead to further deterioration of their health and even death, the court found that actual, irreparable harm had, in the circumstances, already occurred, was continuing to occur and was reasonably apprehended. The GDoH, in arguing that the issues raised would ultimately be dealt with in Cancer Alliance’s review application, was found to appear “insensitive and dismissive” of the actual harm suffered by the patients to whom it owed undisputed constitutional obligations.

The court, therefore, held that a “compelling need” existed in the circumstances for a mechanism to be put in place to ensure that the GDoH was held to account for its constitutionally imposed obligation to provide healthcare services to the patients on the backlog list. The court found that office bearers at the GDoH had “conducted themselves as a law unto themselves” and “decided it inappropriate to be held to account” to Cancer Alliance, which had been acting in the public interest.[4]  As a result, the court issued a supervisory interdict[5] in terms of which the GDoH was ordered to –

• update the backlog list compiled by Cancer Alliance of cancer patients awaiting radiation oncology services in Gauteng within 45 days of the court order;

• take all necessary steps to provide radiation oncology services to the backlog patients awaiting treatment at the hospitals in question, being the Charlotte Maxeke Johannesburg Academic Hospital and Steve Biko Academic Hospital; and

• file a report within three months of the order detailing (i) the steps taken to provide radiation oncology services to cancer patients on the backlog list in Gauteng, and (ii) the GDoH’s long-term plan to provide radiation oncology services at the Gauteng hospitals.

Conclusions

The court’s decision in the Cancer Alliance matter is significant for several reasons –

• first, it reinforces the constitutional obligation resting on the State to provide access to healthcare. The judgment underscores that the State must take positive steps to fulfil this right and cannot neglect its duties, particularly when funds have been allocated for specific health services;

• second, the judgment highlights the importance of accountability and transparency in public administration, with the court having found that the GDoH’s handling of the tender process for radiation oncology services was fraught with delays and inefficiencies; and

• third, the court’s decision to issue a supervisory interdict sets a precedent for future cases where there is a need to ensure compliance with constitutional obligations, particularly with regard to the right to access to healthcare.

The judgment in the Cancer Alliance also underscores the judiciary’s role in ensuring that State entities comply with their constitutional obligations, particularly in the context of the right of access to healthcare, and to do so in a timeous manner.

[1] Constitution of the Republic of South Africa, 1996

[2] Paragraph 523 of the decision in the Cancer Alliance matter

[3] Paragraph 559 of the decision in the Cancer Alliance matter

[4] Paragraph 603 of the decision in the Cancer Alliance matter

[5] Against which decision the GDoH has since noted its intention to appeal

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On 17 November 2023, the Registrar of the Health Professions Council of South Africa (“HPCSA”) published certain amendments to the Ethical Rules for the Conduct of Practitioners Registered under the Health Professions Act, 1974 (GNR 717, dated 4 August 2006) (“the Ethical Rules”).

The amendments are entitled “Proposed Amendments to the Ethical Rules of Conduct for Practitioners Registered under the Health Professions Act, 1974” and were published in Board Notice 510 in GG 49720 (“the Amendment Notice”). Although the title of the Amendment Notice refers to “Proposed Amendments”, the Registrar of the HPCSA has since confirmed that the amendments are indeed final.

The Amendment Notice has the effect of fundamentally changing the landscape in which healthcare “practitioners”,[1] as that term is defined in the Ethical Rules, may collaborate with others. We deal below with certain of the key changes.

Prior to the publication of the Amendment Notice, practitioners were only entitled to receive fees for services personally rendered, or for the services rendered by someone in their employment, which prevented certain alternative models of reimbursement, including global fee agreements. The Amendment Notice has now introduced Rule 7(6) of the Ethical Rules, which provides that ‑ 

“Notwithstanding anything contained in sub-rules (4) and (5) above, a practitioner may share, charge or receive fees from another practitioner: Provided that in such an instance, there is an express agreement, arrangement or model of rendering multi-disciplinary based health-care services to patients which is structured, which provides high quality health-care services or products, contain costs of rendering health-care services, and enhance access to appropriate healthcare”.

A definition for the term “multidisciplinary healthcare” has also been included in the Ethical Rules and means healthcare delivery that involves multiple health practitioners from different professions of healthcare; while “appropriate healthcare” is now defined as healthcare delivery where the expected clinical benefits of care to patients outweighs the expected negative effects to such an extent that the treatment is justified.

Based on the amendments to Rule 7, therefore, further opportunities appear to now be available to practitioners to extend the manner in which they collaborate and consequently bill for healthcare services.

Rule 8 of the Ethical Rules then deals with partnerships and juristic persons in the context of practitioners. In particular, Rule 8 restricts practitioners to practising only in partnerships with each other or in associations where the practitioners concerned are not prohibited, in terms of the Ethical Rules, from entering into such partnerships or associations.

The Amendment Notice now introduces new Rule 8(5) which provides that –

“Notwithstanding anything contained in [Rule 8], a practitioner may provide health-care services with other registered practitioners, persons registered in terms of the [Health Professions Act No. No. 56 of 1974 (‘HPA’)], or in terms of any other legislation regulating health professions: Provided that the primary aim will be to enhance the quality of health-care services to patients, and further that there is an express agreement, arrangement or model of rendering multi-disciplinary based health-care services to patients which provides high quality health-care services or products to patients, structured to contain costs, and enhance access to appropriate healthcare”.

Rule 8, therefore, now authorises collaboration between practitioners in different registration categories provided that an express agreement, arrangement or model is in place which ensures high quality health-care services or products to patients, structures to contain costs, and enhanced access to appropriate healthcare.

A further change in the Ethical Rules relates to Rule 8A. Prior to the enactment of the Amendment Notice, Rule 8A provided that “[a] practitioner shall not share his or her rooms with a person or entity not registered in terms of the Act” – which was interpreted as precluding registered persons from having medical rooms in the same establishment as that of a non-registered entity or person. Rule 8A has now been substituted and reads as follows –

“A practitioner may share his or her rooms with a person registered in terms of the Act, or in terms of any other legislation regulating health professions”.

Once again, therefore, the newly inserted Rule 8A appears to support the establishment of multidisciplinary practices, that may now operate together in the same establishment.

One of the most significant changes to the Ethical Rules is the amendment to Rule 18. Rule 18 deals with professional appointments (including the employment) of healthcare practitioners. The pre-amended wording of Rule 18 read as follows –

“18(1) A practitioner shall accept a professional appointment or employment from employers approved by the council only in accordance with a written contract of appointment or employment which is drawn up on a basis which is in the interest of the public and the profession.

(2) A written contract of appointment or employment referred to in subrule (1) shall be made available to the council at its request”. (our emphasis)[2]

Accordingly, prior to its amendment, Rule 18, read with the Policy, prescribed that a non-registered person or entity may only employ registered practitioners if the non-registered entity obtained permission from the HPCSA to do so – and pursuant to a contract that aligns with the interest of the public and the profession.

Rule 18(1) has now been revised to read as follows (deletions to the previous rule have been reflected in brackets and additions have been underlined) –

“A practitioner shall accept a professional appointment or employment from employers [approved by the council only] in accordance with a written contract of appointment or employment which is drawn up on a basis which is in the interest of the public and the profession: Provided that, the health practitioner ensures that the employment contract has as its primary aim the enhancement of the quality of health-care services to patients, is structured to contain costs, enhance access to appropriate, high quality health-care services or products to patients, and is not designed to extract profit for the benefit of the practitioner or their employer to the detriment of patients”.

Curiously, whilst the Amendment Notice itself provides that deletions to the Ethical Rules are to be reflected in brackets, the term “approved by the council only” has not been reflected in brackets – but has simply been deleted. The draft amendments to the Ethical Rules, which preceded the Amendment Notice[3] also do not propose this deletion.

Be that as it may, we understand that the position of the HPCSA is that non-registered persons are no longer required to apply for approval from the HPCSA to employ registered practitioners to perform clinical services.

This question that then arises is: but, what now of the previous approvals already granted by the HPCSA (many of which were subject to conditions) as well as pending employment applications, which were submitted to the HPCSA before the Amendment Notice was published? The position, as we understand it, is that previous approvals and conditions remain effective; whereas pending applications are now considered redundant and will not be advanced.

The amendment to Rule 18, therefore, goes a long way towards increasing the potential for collaboration between registered and non-registered persons – where the aim is to enhance access to and the quality of healthcare services to patients, and is structured to contain costs as opposed to extracting profit for the benefit of the practitioner or their employer to the detriment of patients.

Whilst the amendment to Rule 18 may be a welcome change, certain practical difficulties exist in the context of Rule 18. In particular, and in relation to the Regulations to the Medical Schemes Act No. 131 of 1998,[4] no provision is made for the issuing of practice code numbers to non-registered persons who lawfully employ registered practitioners to render services to medical schemes members.

How then are registered persons to invoice medical schemes for the clinical services they render in terms of such employment? The answer is unclear and will perhaps precipitate much-needed change in the manner in which practice code numbers are issued.

The employment of registered practitioners by non-registered persons also gives rise to questions regarding the interaction between Rule 18 of the Ethical Rules and section 54A of the HPA. Section 54A of the HPA exempts certain juristic personsfrom the operation of specific provisions of the HPA and allows juristic persons “to practice a profession … in respect of which registration in terms of [the HPA] is a pre-requisite for practising”.

A juristic person applying for an exemption in terms of section 54A must, in turn, comply with certain prescribed requirements in order to qualify for the exemption, including the requirement that the juristic person must be personal liability company.[5]

In so far as juristic persons (including limited liability companies) may employ registered practitioners to provide clinical services to patients, it is difficult to understand why such juristic entities may not also receive an exemption in terms of section 54A of the HPA – which is perhaps a further issue that may need to be revisited and updated in order to keep pace with the times.

Finally, the Amendment Notice also provides for a change to Rule 23A of the Ethical Rules. Rule 23A prescribes various requirements that must be met in order for a practitioner to have a direct or indirect financial interest or shares in a hospital or any other health care institution. One of the requirements is that the practitioner must submit an annual report to the HPCSA containing certain information. The Amendment Notice expands on the reporting requirements in Rule 23A(h) and provides that the report to be submitted to the HPCSA must contain the following information and documents –

1. the number of patients referred by him or her or his or her associates or partners to such hospital or health care institution and the number of patients referred to other hospitals in which he or she or his or her associates or partners hold no shares;
2. the agreements concluded in relation to the acquisition and/or ownership of the interests of shares in the hospital or health care institution;
3. how the acquisition of the financial interest is funded and whether there are other ancillary contractual relationships between all the parties to the transaction or with related parties and entities and if so, the nature of such contractual relationships;
4. policies or peer review protocols for admission of patients into such hospital or health care institution and quality monitoring mechanisms which serve to ensure that practitioners will comply with the Ethical Rules; and
5. any other information or document which the HPCSA may deem relevant.

The relevant practitioner must, in turn, ensure compliance with Rule 23A at all times.

The amendments to the Ethical Rules are therefore far-reaching and are arguably a step in a direction that aligns with an evolving healthcare service arena. The amendments, however, also highlight certain additional changes that need to be addressed in order to ensure consistency in legislation and policy as well as practical efficiency and proper application.

Footnotes

[1] The term “practitioner” is defined in the Ethical Rules as a person registered as such under the HPA and, in the application of certain rules in the Ethical Rules, also a juristic person exempted from registration in terms of section 54A of the HPA

[2] Rule 18 of the Ethical Rules was, in turn, expanded on in paragraph 2.4 of the Business Practices Policy of the HPCSA dated 26 October 2016 (which has yet to be updated), and which provides that –

                  “EMPLOYMENT OF PRACTITIONERS

Generally the employment of practitioners by persons not registered in terms of the Act is not permissible; however the following employment agencies are recognised for the purposes of employing practitioners that are registered under the Health Professions Act:

• The Public Service;

• Universities / Training Institutions (only limited for purposes of training and research);

• Mining companies & NPO’s/NGO’s (subject to approval of the relevant professional board);

• All registered persons within the HPCSA may also employ fellow registered practitioners in accordance with the Ethical rules.

Any other agent; institution; person may lodge an application with the HPCSA for the purposes of employment of a practitioner registered with the [HPCSA] save that any other employment which falls beyond the professional practice is not required to lodge an application with the HPCSA…”.

[3] Proposed Amendments to the Ethical Rules of Conduct for Practitioners Registered under the Health Professions Act, 1974 published in BN 278 in GG 46422 dated 27 May 2022

[4] Published under GN R1262 in GG 20556, dated 20 October 1999

[5] The exemption relating to juristic persons formulated in section 54A of the HPA, is published in

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