IPA Foundation (NPC) v South African Pharmacy Council (1024/2023) [2025] ZASCA 148 (9 October 2025)

82 Reportability
Administrative Law

Brief Summary

Pharmacy — Scope of practice — Pharmacist-initiated management of antiretroviral therapy services — Appeal against decisions of South African Pharmacy Council to implement PIMART — Appellant sought to review and set aside Council's decisions regarding scope expansion — Council's decisions upheld based on procedural fairness and rationality — Appeal dismissed with costs.

Comprehensive Summary

Summary of Judgment


Introduction


The proceedings were an appeal to the Supreme Court of Appeal of South Africa against a judgment and orders of the Gauteng Division of the High Court, Pretoria, sitting as a court of first instance. The appeal concerned an application to review and set aside two decisions of the South African Pharmacy Council relating to the expansion of pharmacists’ scope of practice to include pharmacist-initiated management of antiretroviral therapy (PIMART) services.


The appellant was The IPA Foundation (NPC), a non-profit company owned and controlled by its members, who are family medical practitioners in private practice. The respondent was the South African Pharmacy Council (SAPC), a statutory regulator established under section 2 of the Pharmacy Act 53 of 1974, with objectives that include promoting public health and enhancing pharmaceutical care.


In the High Court, the IPA brought review proceedings under sections 3 and 6 of the Promotion of Administrative Justice Act 3 of 2000 (PAJA), alternatively under a legality review. The High Court dismissed the review application and upheld a strike-out application by the SAPC directed at material introduced in reply. The appeal to the Supreme Court of Appeal was pursued with the leave of the High Court.


The general subject-matter of the dispute was administrative-law review of the SAPC’s regulatory decision-making in the context of public health policy, specifically whether the SAPC acted procedurally fairly and rationally when introducing PIMART and publishing the relevant Board notice implementing it.


Material Facts


The SAPC is the statutory body regulating the pharmacy profession and is responsible for overseeing pharmacists’ training and education and acting as custos morum of the profession. Its functions include promoting public health and enhancing pharmaceutical care.


In 1995, the SAPC issued regulations concerning pharmacist-initiated therapy (PIT) under section 33(1) of the Pharmacy Act. These PIT-related regulations enabled pharmacists, through supplementary or continuing professional development courses, to provide certain services at pharmacies, including HIV testing and post-exposure prophylaxis for healthcare workers.


Antiretrovirals were introduced in the private sector in 2000, and initiation of treatment was restricted to specialists, with initiation predominantly hospital-based. In 2010, Nurse-Initiated Management of Antiretrovirals (NIMART) was introduced in the public health sector, enabling nurses to screen and initiate therapy at primary healthcare clinics. In December 2020, the Department of Health granted special authorisation permitting nurses in private pharmacies to prescribe antiretrovirals at pilot sites if they had completed NIMART training.


Despite these initiatives, HIV infection rates remained high. The Department of Health therefore requested the SAPC to investigate an intervention to increase access to antiretroviral medicines for Pre-Exposure Prophylaxis (PrEP) and Post-Exposure Prophylaxis (PEP). The Department’s initial proposal contemplated petitioning SAHPRA to reclassify certain medicines, but the SAPC decided against reclassification and instead selected PIMART on considerations including accessibility through community pharmacies with extended opening hours.


The SAPC consulted stakeholders including the Southern African HIV Clinicians Society, which provided recommended competency standards for pharmacists to deliver PIMART services. A training model was developed requiring practising pharmacists to undertake supplementary training and to apply for a permit issued by the Director-General under section 22A(15) of the Medicines and Related Substances Act 101 of 1965 to prescribe and dispense specified antiretroviral therapies.


On 22 March 2021, the SAPC published Board Notice 71 of 2021 in the Government Gazette for public comment. The notice set out the proposed scope of practice for PIMART, competency standards, and criteria for curriculum accreditation. Interested parties were invited to submit substantiated comments within 60 days, by 21 May 2021. It was common ground that the IPA did not submit comments within the prescribed period. The SAPC received comments within time from other bodies, which all supported implementation in principle.


The SAPC met with the Director-General on 30 June 2021 to brief her on its plan. On 13 and 14 July 2021, the SAPC considered comments received and decided to introduce PIMART. On 12 August 2021, the Director-General approved the issuance of permits to pharmacists qualified to provide PIMART services.


On 13 August 2021, the SAPC published Board Notice 101 of 2021 in the Government Gazette. The notice announced implementation of PIMART, set out the services accredited pharmacists could provide, and described how training institutions would be approved. The authorised activities included consultations with HIV patients at a pharmacy or approved healthcare setting, including history taking, screening and confirmatory tests, ordering and interpreting tests in line with Department guidelines, initiation of PrEP/PEP and first-line antiretroviral therapy (including TB preventative therapy initiation) within specified constraints, adjustment where necessary, monitoring outcomes, referral to another healthcare provider where necessary, and record keeping.


After publication of Board Notice 101, the IPA submitted comments and objections on 8 September 2021. A meeting of the Forum of Statutory Health Professional Councils occurred on 27 September 2021 where concerns were raised and the SAPC responded by presentation. No subsequent resolutions by the Forum were recorded in the judgment.


On 11 October 2021, the IPA requested reasons from the SAPC under section 5 of PAJA for implementing amendments expanding pharmacists’ scope to include PIMART. The SAPC did not respond. The IPA then brought review proceedings on 8 February 2022.


A further fact material to the procedural posture was that in its replying affidavit in the High Court, the IPA attached affidavits from several professional associations opposing PIMART. The SAPC objected that this constituted new matter raised in reply and sought to have it struck out. The High Court struck out the affidavits as impermissible new matter.


Legal Issues


The Supreme Court of Appeal identified four issues requiring determination.


The first issue was whether the High Court correctly granted the SAPC’s strike-out application in relation to material introduced by the IPA in reply. This was primarily a procedural issue concerning the permissible scope of replying affidavits in motion proceedings and whether the IPA attempted to make out a new case in reply.


The second issue was whether the IPA had standing to bring the review application. This issue involved the application of constitutional and administrative-law standing principles, including the interpretation of section 3(1) of PAJA and section 38 of the Constitution.


The third issue was whether the publication of Board Notice 71 for public comment complied with procedural fairness under section 3 of PAJA, taking account of circumstances raised by the IPA, including the timing during the COVID-19 pandemic and the method of publication (Government Gazette).


The fourth issue was whether the introduction and implementation of PIMART was rational, both as a general legality requirement and under the rationality-related grounds in section 6(2) of PAJA. This included the IPA’s contentions that the SAPC lacked authority to adopt PIMART insofar as it allegedly encroached upon the professional domain of medical practitioners, and that the scheme conflicted with existing legislation such as the Medicines Act and the Health Professions Act.


These issues involved questions of law and the application of legal standards to largely common-cause facts, including evaluative judgments about procedural fairness in context and rational connection between means and ends in the rationality enquiry.


Court’s Reasoning


The Supreme Court of Appeal approached the appeal by dealing sequentially with the strike-out, standing, procedural fairness, and rationality challenges, and by assessing the IPA’s residual grounds under PAJA.


On the strike-out issue, the Court held that the High Court correctly struck out the affidavits and related material introduced in the replying affidavit. The Court distinguished the authorities relied upon by the IPA. It reasoned that the replying affidavit material was not merely clarification or permissible elaboration of an existing case, nor was it justified by urgent practical constraints of the kind accepted in prior cases. Instead, the Court found that the IPA sought to bolster its grounds of review by introducing substantive supporting affidavits from non-parties that were not mentioned in the founding papers and were not before the SAPC. The Court applied the principle that an applicant must stand or fall by the averments made in the founding affidavit, and that it is impermissible to make out a new case in reply. It further rejected the argument that the High Court should have sifted paragraph-by-paragraph, holding that it was not the court’s duty to separate offensive from permissible matter, and noting that the IPA itself did not identify severable portions.


On standing, the Court rejected the SAPC’s submission that section 3(1) of PAJA required the IPA to demonstrate that Board Notice 101 affected the rights or legitimate expectations of its members in a narrow private-law sense. The Court relied on Constitutional Court authority interpreting section 3(1) generously to give effect to section 33(1) of the Constitution and recognising that “rights” in this context include legal entitlements grounded in constitutional and statutory obligations of government. The Court accepted that section 38 of the Constitution supports a broad approach to standing in PAJA review. It reasoned that PIMART concerns public health and falls within the field in which IPA members operate, and that judicial scrutiny of PIMART’s conceptualisation and implementation at the instance of the IPA was in the interests of the administration of justice given the impact upon the professional work of IPA members. On this basis, the Court held the IPA had standing.


On procedural fairness under section 3 of PAJA, the Court emphasised that fairness depends on the circumstances of each case. The IPA’s procedural fairness complaints focused on timing (during the COVID-19 pandemic) and method of publication (Gazette only, allegedly not widely read). Regarding timing, the Court noted that other interested bodies were able to respond within the 60-day period and did so; the Court treated this as undermining the proposition that timing made participation unreasonable. It accepted the High Court’s observation that the IPA is a juristic person separate from its members and found no basis to conclude that the pandemic prevented the IPA from engaging in the process. The Court considered the 60-day comment period adequate and noted that the IPA accepted it submitted comments only after the deadline and after Board Notice 101 had been published.


Regarding the method of publication, the Court found that Board Notice 71 was published in the Gazette and on the SAPC’s website, and that publication in the Gazette was required by section 49(4) of the Pharmacy Act. The Court reasoned that the IPA did not challenge the validity of section 49(4) or contend that the statutory notification procedure was inconsistent with PAJA. In the absence of such a challenge, the Court held it was not open to the IPA to argue that the SAPC’s compliance with the statutory requirement was insufficient and that additional steps (such as publication in a doctors’ journal) were legally required. The Court therefore concluded that procedural fairness requirements were met through the Gazette publication and opportunity to comment.


On rationality, the Court dealt with the fact that the IPA had not pleaded rationality in its founding papers, having introduced it in the notice of appeal and developed it in written argument. While noting that the SAPC did not have an opportunity to respond in the High Court papers, the Court nevertheless found there was sufficient factual material on record to assess procedural rationality and that no prejudice resulted.


The Court applied the constitutional rationality standard as articulated by the Constitutional Court, namely that the enquiry concerns whether the means chosen are rationally connected to the purpose sought to be achieved, rather than whether different means could have been used. On the facts, the Court accepted that persistent high infection rates and the need to improve access to prevention tools and first-line treatment underpinned the Department’s request and the SAPC’s decision to pursue PIMART. The Court emphasised accessibility of community pharmacies and unchallenged evidence that large numbers of people in rural areas remain undiagnosed and untreated. It further noted that the development of PIMART involved consultation with the HIV Clinicians Society and the creation of specialised training for pharmacists. The Court concluded that PIMART was rationally connected to improving access to first-line HIV treatment and was aligned with the SAPC’s objectives and the State’s obligations under section 27(2) of the Constitution.


In addressing rationality under section 6(2) of PAJA, the Court dealt principally with two submissions advanced by the IPA. The first was that PIMART was not authorised by the empowering provisions and impermissibly encroached upon the domain of medical practitioners. The Court rejected the characterisation of PIMART as a blanket licence for pharmacists to treat HIV patients. It emphasised that PIMART was limited in scope, applied only to accredited pharmacists, was confined to prevention and first-line therapy for uncomplicated, specified categories of patients, and required adherence to Department guidelines. The Court also reasoned that medical practitioners do not hold exclusive rights to care for people living with HIV/AIDS and that HIV care is a collaborative effort across health professions, including nurses under NIMART.


The second submission was that PIMART conflicted with existing legislation, especially the Medicines Act, because pharmacists generally may not prescribe scheduled substances (Schedules 3–5) without prescription. The Court held that section 22A(15) of the Medicines Act expressly empowers the Director-General, after consultation with the SAPC, to issue permits authorising persons or organisations performing health services to acquire, possess, use, or supply specified Schedule 1–5 substances subject to conditions. The Court treated this provision as decisive in answering the asserted statutory conflict, noting that the Director-General utilised section 22A(15) to permit qualified pharmacists to apply for relevant permits and that the IPA did not challenge the validity of this empowering provision. The Court therefore found the IPA’s contention that the Medicines Act prohibited such prescribing to be unsustainable in the face of section 22A(15).


In relation to the IPA’s residual PAJA complaints, the Court accepted the High Court’s conclusion that the SAPC considered relevant factors, evaluated risks, and adopted a rigorous accreditation and training process. It held that there was no foundation to assert that the SAPC considered irrelevant matters, acted arbitrarily or capriciously, or lacked rational connection to the purposes of the decision and empowering provisions. On the complaint that the SAPC failed to provide reasons upon request, the Court referred to section 5(3) of PAJA and the rebuttable presumption that an administrative action taken without reasons is presumed to be without good reason. The Court held that, in the subsequent review proceedings, the SAPC had discharged the burden to rebut the presumption, and counsel for the IPA did not contend otherwise.


Finally, the Court addressed a criticism directed at the High Court’s reasoning regarding whether Gazette publication of the adoption of PIMART was statutorily required, noting that nothing turned on that reasoning because the appeal lies against the order, not the reasons, and the High Court had concluded procedural fairness was met in any event.


Outcome and Relief


The Supreme Court of Appeal dismissed the appeal. It upheld the High Court’s decision to strike out the new material introduced in reply, confirmed that the IPA had standing, and found that the SAPC’s process satisfied procedural fairness requirements and that the adoption and implementation of PIMART was rational and compliant with PAJA review standards.


The Court ordered that the appeal be dismissed with costs, including the costs of two counsel.


Cases Cited


Joseph and Others v City of Johannesburg and Others [2009] ZACC 30; 2010 (3) BCLR 212 (CC); 2010 (4) SA 55 (CC)


Walele v City of Cape Town and Others [2008] ZACC 11; 2008 (6) SA 129 (CC); 2008 (11) BCLR 1067 (CC)


Giant Concerts CC v Rinaldo Investments (Pty) Ltd and Others [2012] ZACC 28; 2013 (3) BCLR 251 (CC)


Mkhize NO v Premier of the Province of KwaZulu-Natal and Others [2018] ZACC 50; 2019 (3) BCLR 360 (CC)


Kruger v President of the Republic of South Africa and Others [2008] ZACC 17; 2009 (1) SA 417 (CC); 2009 (3) BCLR 268 (CC)


Zondi v MEC for Traditional and Local Government Affairs and Others [2004] ZACC 19; 2005 (3) SA 589 (CC); 2005 (4) BCLR 347 (CC)


Janse van Rensburg and Another v Minister of Trade and Industry and Another [2000] ZACC 18; 2001 (1) SA 29; 2000 (11) BCLR 1235 (CC)


Minister of Public Works and Others v Kyalami Ridge Environmental Association and Another (Mukhwevho Intervening) [2001] ZACC 19; 2001 (3) SA 1151 (CC); 2001 (7) BCLR 652 (CC)


Premier, Province of Mpumalanga, and Another v Executive Committee of the Association of State-Aided Schools, Eastern Transvaal [1998] ZACC 20; 1999 (2) SA 91 (CC); 1999 (2) BCLR 151 (CC)


President of the Republic of South Africa and Others v South African Rugby Football Union and Others [1999] ZACC 11; 2000 (1) SA 1 (CC); 1999 (10) BCLR 1059 (CC)


Law Society of South Africa and Others v President of the Republic of South Africa and Others [2018] ZACC 51; 2019 (3) BCLR 329 (CC); 2019 (3) SA 30 (CC)


Albutt v Centre for the Study of Violence and Reconciliation and Others [2010] ZACC 4; 2010 (3) SA 293 (CC); 2010 (2) SACR 101 (CC); 2010 (5) BCLR 391 (CC)


Democratic Alliance v President of South Africa and Others [2012] ZACC 24; 2013 (1) SA 248 (CC); 2012 (12) BCLR 1297 (CC)


Drift Supersand (Pty) Ltd v Mogale City Local Municipality [2017] ZASCA 118; [2017] 4 All SA 623 (SCA)


Lagoon Beach Hotel (Pty) Limited v Lehane N O and Others [2015] ZASCA 210; [2016] 1 All SA 660 (SCA); 2016 (3) SA 143 (SCA)


Director of Hospital Services v Mistry 1979 (1) SA 626 (A)


National Council of Societies for the Prevention of Cruelty to Animals v Openshaw [2008] 4 All SA 225 (SCA); 2008 (5) SA 339 (SCA)


Mostert v FirstRand Bank t/a RMB Private Bank [2018] ZASCA 54; 2018 (4) SA 443 (SCA)


ABSA Bank Ltd v Mkhize, Absa Bank Ltd v Chetty; Absa Bank Ltd v Mlipha [2013] ZASCA 139; [2014] 1 All SA 1 (SCA); 2014 (5) SA 16 (SCA)


Western Johannesburg Rent Board v Ursula Mansions (Pty) Ltd 1948 (3) SA 353 (A)


Legislation Cited


Pharmacy Act 53 of 1974


Medicines and Related Substances Act 101 of 1965


Promotion of Administrative Justice Act 3 of 2000


Health Professions Act 56 of 1974


Constitution of the Republic of South Africa, 1996


Rules of Court Cited


No rules of court were cited in the judgment.


Held


The Court held that the High Court correctly struck out affidavits and material introduced for the first time in the replying affidavit because they constituted impermissible new matter aimed at strengthening the review case rather than rebutting the answering affidavit.


The Court held that the IPA had standing to bring the review application, applying a broad approach to standing under section 38 of the Constitution read with PAJA, and considering the public-health context and the relevance of the subject matter to the field in which the IPA’s members operate.


The Court held that the SAPC complied with procedural fairness requirements under section 3 of PAJA by publishing Board Notice 71 in the Government Gazette (as required by section 49(4) of the Pharmacy Act) and inviting public comment within a 60-day period, and that the IPA’s complaints about timing and the Gazette as a medium did not establish procedural unfairness in the circumstances, particularly absent any challenge to the adequacy or validity of the statutory publication mechanism.


The Court held that the introduction and implementation of PIMART was rationally connected to legitimate public-health objectives, including improving access to HIV prevention and first-line treatment, and that the scheme was supported by consultation and a training and accreditation framework. The Court further held that the IPA’s arguments alleging statutory conflict were undermined by section 22A(15) of the Medicines and Related Substances Act, which authorises permits enabling non-medical practitioners to supply specified scheduled substances, and whose validity was not challenged.


LEGAL PRINCIPLES


Procedural fairness under section 3 of PAJA is context-specific and must be assessed in light of the circumstances of the case, but where an administrator follows a legislatively prescribed notice-and-comment process and the empowering statute’s procedure is not challenged, a litigant cannot, without challenging the statute, insist that additional consultative steps are legally required beyond compliance with the statutory mechanism.


In motion proceedings, an applicant must stand or fall by the founding affidavit, and it is impermissible to introduce substantive new evidence and argument in reply that materially supplements the case for relief, rather than responding to matters raised in the answering affidavit.


Standing in administrative-law review under PAJA is approached broadly in light of section 38 of the Constitution, and “rights” relevant to section 3(1) of PAJA include not only private-law rights but also legal entitlements grounded in constitutional and statutory obligations of government.


Rationality review evaluates whether the means employed are rationally connected to the purpose for which the power was conferred, focusing on the relationship between means and ends rather than whether alternative means might achieve the purpose better. Where the factual record demonstrates a rational link between a regulatory intervention and its public purpose, rationality challenges fail.


Where an administrator fails to furnish reasons on request, section 5(3) of PAJA creates a rebuttable presumption that the administrative action was taken without good reason, but that presumption may be rebutted in review proceedings by the administrator on the record before the court.

THE SUPREME COURT OF APPEAL OF SOUTH AFRICA
JUDGMENT

Reportable
Case no: 1024/2023

In the matter between:
THE IPA FOUNDATION (NPC) APPELLANT

and

SOUTH AFRICAN PHARMACY COUNCIL RESPONDENT

Neutral citation: The IPA Foundation (NPC) v South African Pharmacy Council
(1024/2023) [2025] ZASCA 148 (9 October 2025)
Coram: MAKGOKA, N ICHOLLS, H UGHES and U NTERHALTER JJA
and CHILI AJA
Heard: 22 November 2024
Delivered: This judgment was handed down electronically by circulation to the
parties’ representatives by email, publication on the Supreme Court of Appeal
website and released to SAFLII. The date and time for hand -down of the
judgment is deemed to be 11h00 on 9 October 2025.
Summary: Pharmacy Act 53 of 1974 – Pharmacy Council’s power to expand
the scope of practice of pharmacists to provide pharmacist-initiated management
of antiretroviral therapy services – procedural fairness and rationality of
Council’s decision.

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___________________________________________________________________

ORDER
___________________________________________________________________

On appeal from: Gauteng Division of the High Court, Pretoria ( Van der
Schyff J, sitting as court of first instance):
The appeal is dismissed with costs, including the costs of two counsel.
___________________________________________________________________

JUDGMENT
___________________________________________________________________
Makgoka JA ( Nicholls, Hughes, and Unterhalter JJA and Chili AJA
concurring):
[1] This case concerns primary health care for people living with human
immunodeficiency virus/acquired immunodeficiency syndrome ( HIV/AIDS).
The appellant, the Independent Practitioners Association Foundation ( the IPA),
appeals against certain orders of the Gauteng Division of the High Court, Pretoria
(the high court). The court dismissed its application to set aside two decisions of
the respondent, the South African Pharmacy Council (the SAPC). The appeal is
with the leave of the high court.

The parties
[2] The IPA is a non -profit company that is wholly owned and controlled by
its members, who are family medical practitioners in private practice. The SAPC
is a statutory body and regulator of the pharmacy profession, established in terms
of s 2 of the Pharmacy Act 53 of 1974 (the Pharmacy Act). The SAPC’s
objectives include promoting the health of the South African population and
enhancing pharmaceutical care for patients. In pursuing these objectives, the
SAPC is obliged to oversee the training and education of pharmacists, enabling
them to fulfil their professional responsibilities in providing healthcare to the

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public. The SAPC is also the custos morum (the custodian of morals and ethics)
of the pharmacy profession.

The impugned decisions
[3] The two decisions of the SAPC that the IPA sought to review and set aside
are these. First, the SAPC’s approval of the implementation of the scope of
practice for pharmacists who provide pharmacist -initiated management of
antiretroviral therapy (PIMART) services. This initiative allows accredit ed
pharmacists to administer first-line therapy for the treatment and management of
HIV/AIDS. The implementation of PIMART required amendments to the
Pharmacy Act to expand the scope of practice for speci fically qualified
pharmacists providing PIMART services. Such pharmacists would be able to,
among other things, conduct consultations with HIV patients at a pharmacy or at
an approved healthcare setting.

[4] The second decision, linked to the first, is the SAPC’s publication of Board
Notice 101 of 2021 (Board Notice 101) in the Government Gazette (the Gazette)
dated 13 August 2021. This notice outlined: (a) the implementation of PIMART
services; (b) the competency standards for such pharmacists; and (c) the criteria
for approving a curriculum for a PIMART course. The publication of Board
Notice 101 was preceded by Board Notice 71 of 2021, published in the Gazette
on 22 March 2021 (Board Notice 71). Although the IPA does not challenge this
notice, it contends that it is related to Board Notice 101 of 2021.

Factual background
[5] In 1995, the SAPC, in accordance with s 33(1) of the Pharmacy Act, issued
regulations concerning pharmacist-initiated therapy (PIT) that could be obtained
through supplementary or continuing professional development courses for
pharmacists already registered in terms of the Pharmacy Act. These regulations

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allowed pharmacists to provide services such as HIV testing, emergency post -
coital contraception, pregnancy testing, urine test analysis, sexual health advice,
and occupational post -exposure HIV prophylaxis for healthcare workers at a
pharmacy. In 2000, antiretrovirals (ARVs) were first introduced in the private
sector for people living with HIV/AIDS . Only specialists were permitted to
initiate treatment. Therefore, the initiation of ARVs could only be carried out by
healthcare providers and was predominantly hospital-based.

[6] In 2010, Nurse -Initiated Management of Antiretrovirals (NIMART) was
introduced in the public health sector, allowing nurses to screen people living
with HIV/AIDS and initiate antiretroviral therapy at primary healthcare clinics
across the country. In December 2020, the Department of Health (the department)
granted special authorisation that permitted nurses in private pharmacies to
prescribe ARVs at pilot sites, provided these nurses had completed the NIMART
training.

[7] Despite all the se initiatives, the number of HIV infections remained
persistently high. For example, in 2010, the number had increased from 5.7
million to 8.2 million, despite improved access through NIMART. This high rate
of new HIV infections underscored the necessity for intensified prevention
efforts. As infections continued to rise, the HIV-related budget grew substantially
over the years. The department spent more than R20 billion, on HIV alone, in the
2019/2020 financial year. Consequently, there was a need to explore different
methods to curb the rising number of new HIV infections.

[8] In light of the above, the department requested the SAPC, as the regulator
of the pharmacy profession, to investigate an intervention aimed at increasing
patients’ access to antiretroviral medicines for Pre-Exposure Prophylaxis (PrEP)
and Post-Exposure Prophylaxis (PEP). The department’s initial proposal was for

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the SAPC to ‘petition the South African Health Products Regulatory Authority
(SAHPRA) to potentially [reclassify] certain medicines used for treating HIV, for
the purposes of PrEP and PEP’.

[9] Ordinarily, pharmacists are only permitted to dispense Schedule 1 and 2
medicines without a prescription from an authorised prescriber. The aim was to
reclassify some of the medicines under Schedules 3 and 4, to Schedule 2, allowing
pharmacists to prescribe and dispense them without a prescription from another
authorised prescriber. This would form part of pharmacist -initiated therapy,
which involves diagnosing, treating, and managing illnesses and minor ailmen ts
by pharmacists under ss 22A(5) and 22A(6) of the Medicines and Related
Substances Act 101 of 1965 (the Medicines Act).

[10] The SAPC investigated the matter and consulted, among others, the
Southern African HIV Clinicians Society (HIV Clinicians Society). On 15 August
2018, the SAPC informed the Director-General of the department (the Director-
General) of the department that it had decided against the department’s proposal
for reclassifying certain medicines under Schedule 2. Instead, it selected
PIMART, considering, among other things, the issue of accessibility. It stated that
many community pharmacies offer HIV screening and have extended opening
hours, which allow for timely access to HIV prevention tools such as PrEP and
PEP.

[11] Regarding the qualification to offer PIMART services, the SAPC
envisioned that practising pharmacists would need to undertake supplementary
training. The training would include understanding global HIV trends,
recognising the scale of the HIV epidemic in South Africa, understanding
transmission risks per exposure, and grasping the aims and objectives of the
treatment.

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[12] Upon completing such training, pharmacists would need to apply for a
PIMART permit, which would be issued by the Director-General under s 22A(15)
of the Medicines Act. This permit would allow the accredited pharmacists ‘to
prescribe and dispense [antiretroviral therapy] ART medicines for PrEP, PEP
and, where appropriate, first line ARV therapy ’. Concerning the competency
standards for the pharmacists’ supplementary training, the SAPC consulted with
the Southern African HIV Clinicians Society (the Clinicians Society) , which
provided the recommended competency standards that a pharmacist should meet
to deliver PIMART services. These standards were developed by medical experts
and subsequently submitted to the North -West University School of Pharmacy
‘to assess the competencies obtained in the Bachelor of Pharmacy and the
additional training that would be required for pharmacists to provide PIMART
services’.

[13] On 22 March 2021, the SAPC published Board Notice 71 in the Gazette
for public comment and stakeholder engagement regarding its proposed adoption
of PIMART. The schedule attached to the notice outlined: (a) the scope of
practice of a pharmacist who provides PIMART services; (b) competency
standards for a pharmacist offering PIMART services; and (c) criteria for
accreditation or approval by the SAPC of a curriculum leading to the awarding
of a PIMART course.

[14] Interested parties and stakeholders were invited to submit, within 60 days
of publication, substantiated comments or representations concerning PIMART.
The prescribed notice period ended on 21 May 2021. It is common ground that
the IPA did not submit any comments within the specified period. However, the
SAPC received comments from interested parties within the same period, all of
which, in principle, supported the implementation of PIMART.

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[15] On 30 June 2021, the SAPC met with the Director-General to brief her on
its plan to implement PIMART and related matters. On 13 and 14 July 2021, it
held meetings to consider the comments received in response to Board Notice 71,
and a decision was made to introduce PIMART. On 12 August 2021, the Director-
General approved the issuance of permits to pharmacists qualified to provide
PIMART services.

[16] On 13 August 2021, the SAPC announced its decision to introduce
PIMART in Board Notice 101. The SAPC informed interested parties of the
services a PIMART-accredited pharmacist would be entitled to offer and how it
would approve institutions providing the required supplementary training that
pharmacists must complete to apply for PIMA RT accreditation. Regarding the
decision, a pharmacist who has completed the PIMART supplementary training
would be permitted to conduct consultations with people living with HIV/AIDS
at a pharmacy or an approved healthcare setting, which includes the following:
‘(a) history taking, performing of screening and confirmatory tests, ordering, conducting
and interpretation of diagnostic and laboratory tests in line with [the department’s]
guidelines (for diagnosis, clinical staging and assessment of an HIV infected patient or
those at high risk of contracting HIV);
(b) assess and manage the HIV -infected patients or those at high risk of contracting HIV
who require [PrEP and PEP], who are not pregnant or under 15 years of age;
(c) a decision on safe and appropriate therapy;
(d) initiate antiretroviral treatment limited to PrEP, PEP and first line [ART] plus initiation
of TB-Preventative Therapy (TPT) in line with [the department’s] guidelines;
(e) adjustment of ART (where necessary) which has been prescribed previously;
(f) monitoring of the outcomes of therapy;
(g) referral to another health care provider where necessary, e.g., discordant results; and
(h) confidential and adequate record keeping.’

(h) confidential and adequate record keeping.’
[17] On 8 September 2021, following the publication of Board Notice 101,
which introduced the implementation of PIMART, the IPA submitted its

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comments and objections to the SAPC regarding the implementation of PIMART.
On 27 September 2021, the Forum of Statutory Health Professional Councils
(the Forum) held a meeting to discuss, among other things, Board Notice 101.
The Forum comprises the Health Professions Council of South Africa (HPCSA),
the South African Nursing Council (SANC), and the Allied Health Professions
Council of South Africa (APCSA). These health bodies raised some concerns.
The SAPC delivered a presentation in which it responded to the comments and
endeavoured to address the concerns raised. The Forum agreed to further engage
on Board Notice 101, through a subcommittee. No subsequent resolutions seem
to have been made by the Forum in this regard.

[18] On 11 October 2021, the IPA requested the SAPC to provide reasons under
s 5 of the Promotion of Administrative Justice Act 3 of 2000 ( the PAJA) for
implementing the amendments to the Pharmacy Act, which expanded the scope
of practice for pharmacists to include PIMART services. The SAPC did not
respond to the request.

In the high court
[19] On 8 February 2022, the IPA lodged a review in the high court. The
application was based on s 3 and s 6 of the PAJA, alternatively by way of a
legality review. The IPA claimed that the publication of Board Notice 71, in
March 2021, only in the Government Gazette, did not provide adequate notice of
the nature and purpose of the proposed administrative action, namely the
implementation of PIMART. It also contended that the notice, which led to the
publication of Board Notice 101 in August 2021, did not provide its members
with a reasonable opportunity to make representations regarding the
implementation of PIMART.

9

[20] This was particularly true, the IPA contended, considering PIMART’s
supposed adverse effect on its members and the ‘particular circumstances at the
time’. The IPA alleged that the notice violated s 3 of the PAJA. Accordingly,
the IPA argued that the implementation of PIMART lacked procedural fairness.
Furthermore, the IPA argued that both the decision by the SAPC to adopt the
notice and to publish it for implementation violated various provisions of s 6(2)
of the PAJA.

[21] In its replying affidavit, the IPA attached supporting affidavits from several
professional associations opposing PIMART . It listed nine professional
associations in this regard. The SAPC objected to this. Among the grounds for its
objection was that the IPA sought impermissibly to make out a new case in reply.
It accordingly applied to have those parts of the replying affidavit struck out.

[22] The high court observed that the professional associations mentioned in the
replying affidavit were not parties to the litigation, and the supporting affidavits
accompanying the replying affidavit had not been submitted to the SAPC for
consideration, nor did they form part of the record. Consequently, the high court
struck out these affidavits in the replying affidavit as new matter.

[23] Regarding procedural fairness, the high court found that the SAPC had
provided sufficient notice of its intention to adopt PIMART; that the nature and
purpose of PIMART were clearly explained; and that the IPA and other interested
parties were given a reasonable opportunity to comment or make representations.
The high court therefore concluded that the SAPC’s administrative action was
procedurally fair.

[24] As to the substantive grounds of review under s 6(2) of the PAJA, the high
court held that the decision to utilise PIT as a vehicle for PIMART and to enable

10

adequately trained pharmacists to provide PIMART services was rationally
connected to: (a) the purpose for which it was made; (b) the information before
the SAPC; and (c) the reasons given by the SAPC. The high court found that this
decision was rationally connected to the SAPC’s objectives to assist in the fight
against HIV/AIDS. On these grounds, the high court dismissed the IPA’s review
application.

The issues in this Court
[25] The parties persisted with the arguments they had advanced in the high
court. In addition, the IPA challenged the decision of the high court to strike out
material from its replying affidavit. Accordingly, the four issues for
determination, which I will consider in turn, are whether:
(a) the high court correctly granted the SAPC’s strike-out application;
(b) the IPA had standing to bring the application;
(c) the publication of Board Notice 71 was procedurally fair;
(d) the introduction of PIMART was rational, generally, and in terms of s 6 of
the PAJA.

The strike-out application
[26] The IPA contended that the high court erred in striking out annexures
contained in its replying affidavit . It argued that these were attached in rebuttal
of the SAPC’s defences, and sought to rely on Drift Supersand (Pty) Ltd v Mogale
City Local Municipality (Drift Supersand )1 and Lagoon Beach Hotel (Pty)
Limited v Lehane N O and Others (Lagoon Beach Hotel).2


1 Drif Supersand (Pty) Ltd v Mogale City Local Municipality [2017] ZASCA 118; [2017] 4 All SA 623 (SCA)
para 10.
2 Lagoon Beach Hotel v Lehane [2015] ZASCA 210; [2016] 1 All SA 660 (SCA); 2016 (3) SA 143 (SCA).

11

[27] Neither of these cases supports the IPA’s position. In Drift Supersand, this
Court found that the appellant’s replying affidavit did not introduce new grounds
for the application but instead clarified and elaborated on its original claims
regarding its standing and the effect of the municipality’s decision. In Lagoon
Beach Hotel , the amplification of the appellant’s case in reply was permitted
because of the urgency of the matter and the absence of a deponent. The Court
considered the practical difficulties faced by the appellant in gathering evidence
in a short space of time.

[28] In the present case, the IPA aimed to bolster their grounds of review in its
replying affidavit. By including affidavits from several associations that had not
been mentioned in the founding papers, it sought to support its review application
with new evidence and arguments that were not part of its initial case. The
affidavits were introduced to strengthen the IPA’s case. The supporting affidavits
contained substantive arguments in favour of the primary relief claimed in the
founding affidavit , rather than by way of rebuttal of the averments in the
answering affidavit. They, therefore, constituted new material introduced for the
first time in the replying affidavit. It is trite that an applicant must stand or fall by
the averments made out in its founding affidavit. It was therefore impermissible
for the IPA to make out a new case in the replying affidavit.3

[29] IPA also submitted that the high court did not exercise its discretion
properly. It argued that the court should not have struck out the material in its
entirety but should have examined it paragraph by paragraph to identify those
parts that were offensive and those that could be justified. There is no merit in
this contention. It is not a court’s duty to sift through affidavits to determine

3 Director of Hospital Services v Mistry 1979 (1) SA 626 (A) at 636A; National Council of Societies for the

Prevention of Cruelty to Animals v Openshaw [2008] 4 All SA 225 (SCA); 2008 (5) SA 339 (SCA); [2008] 4 All
SA 225 (SCA) paras 29 -30; Mostert v FirstRand Bank t/a RMB Private Bank [2018] ZASCA 54; 2018 (4) SA
443 (SCA) para 13.

12

which parts are offensive. It is the IPA that should have undertaken this exercise
if it wished to argue that certain portions were severable. Even in this Court, the
IPA has not distinguished between the portions that should be retained and those
that should be discarded. For all the reasons stated above, the high court was
correct to strike them out.

The IPA’s standing
[30] The IPA relied on s 3(1) of the PAJA, which provides that ‘administrative
action which materially and adversely affects the rights or legitimate expectations
of any person must be procedurally fair.’ The SAPC contended that s 3(1) of the
PAJA required the IPA to show that Board Notice 101 affects the rights or
legitimate expectations of the IPA’s members and, consequently, it should be
non-suited if it fails to do so. I disagree. The reach of s 3(1) was explained by the
Constitutional Court in Joseph v City of Johannesburg (Joseph),4 as follows:
‘. . . The structure of section 3(1) is important as it indicates the broad application of the
procedural fairness provisions under PAJA. In Walele,5 in considering a procedural fairness
claim based on an alleged legitimate expectation, this Court emphasised that section 3 of PAJA
must be interpreted generously to give proper effect to section 33(1) of the Constitution. 6
O’Regan J, writing for the minority, observed that “[w]e must be careful, in construing section
3(1), to bear in mind that it is the key provision in PAJA that gives effect to the right entrenched
in section 33(1) of the Constitution.”’7

[31] The Court held further that the rights under s 3(1) of the PAJA should be
construed not only to refer to private law rights, ‘but also legal entitlements that
have their basis in the constitutional and statutory obligations of government’. 8
Furthermore, the IPA has standing to bring the review application under s 38 of

4 Joseph and Others v City of Johannesburg and Others [2009] ZACC 30; 2010 (3) BCLR 212 (CC); 2010 (4)
SA 55 (CC) (Joseph).

SA 55 (CC) (Joseph).
5 Walele v City of Cape Town and Others [2008] ZACC 11; 2008 (6) SA 129 (CC); 2008 (11) BCLR 1067 (CC).
6 Section 33(1) of the Constitution provides: ‘ Everyone has the right to administrative action that is lawful,
reasonable and procedurally fair.’
7 Joseph para 40.
8 Ibid para 42.

13

the Constitution,9 and in this context, our courts have adopted a broad approach
to standing in matters such as these. In Giant Concerts v Rinaldo Investments,10
the Constitutional Court referred, with approval, to the assertion by Hoexter that
where a review application is brought under the PAJA, s 38 of the Constitution
should be read into the PAJA.11

[32] The Constitutional Court also held, in Mkhize v Premier of the Province of
KwaZulu-Natal,12 that where review of public power is challenged under the
PAJA, a broad approach to standing under s 38 should apply. In Kruger v
President of the Republic of South Africa ,13 the Constitutional Court recognised
the standing of an attorney who applied in his own interest, and in the public
interest, for a proclamation to be declared invalid in circumstances where s 38
was not of direct application. The Court explained:
‘. . . Where the practitioner can establish both that a proclamation is of direct and central importance to
the field in which he or she operates, and that it is in the interests of the administration of justice that
the validity of that proclamation be de termined by a court, that practitioner may approach a court to
challenge the validity of such a proclamation. . .’14

[33] In the present case, PIMART concerns public health, specifically focused
on increasing access to therapy for people living with HIV/AIDS. This is the field

9 This section provides:
‘Enforcement of rights
Anyone listed in this section has the right to approach a competent court, alleging that a right in the Bill of Rights
has been infringed or threatened, and the court may grant appropriate relief, including a declaration of rights. The
persons who may approach a court are-
(a) anyone acting in their own interest;
(b) anyone acting on behalf of another person who cannot act in their own name;
(c) anyone acting as a member of, or in the interest of, a group or class of persons;
(d) anyone acting in the public interest; and

(d) anyone acting in the public interest; and
(e) an association acting in the interest of its members.’
10 Giant Concerts CC v Rinaldo Investments (Pty) Ltd and Others [2012] ZACC 28; 2013 (3) BCLR 251 (CC)
para 29.
11 C Hoexter Administrative Law in South Africa 2 ed (2012) at 494.
12 Mkhize NO v Premier of the Province of KwaZulu -Natal and Others [2018] ZACC 50; 2019 (3) BCLR 360
(CC).
13 Kruger v President of the Republic of South Africa and Others [2008] ZACC 17; 2009 (1) SA 417 (CC); 2009
(3) BCLR 268 (CC).
14 Ibid para 25.

14

in which the IPA’s members operate. It is therefore necessary and in the interests
of the administration of justice to subject PIMART’s conceptualisation and
implementation to judicial scrutiny at the instance of the IPA, given the impact
of PIMART upon the professional work conducted by the members of the IPA. I
am therefore satisfied that the IPA has established the necessary standing.

Procedural fairness
[34] Hoexter and Penfold describe t he importance of procedural fairness as
follows:
‘Procedural fairness . . . is concerned with giving people an opportunity to participate in the
decisions that will affect them, and – crucially – a chance of influencing the outcome of those
decisions. Such participation is a safeguard that not only signal s respect for the dignity and
worth of the participants, but is also likely to improve the quality and rationality of
administrative decision-making and to enhance its legitimacy.’15

[35] The IPA argued that the publication of Board Notice 71 did not provide
sufficient notice to its members because: (a) it was issued at an inconvenient
time when members were busy dealing with the COVID-19 pandemic; and (b) it
was only published in the Government Gazette, a publication that, according to
the IPA, is not generally read. Therefore, the IPA claimed that the publication of
Board Notice 71 was procedurally unfair in terms of s 3 of the PAJA.16

15 C Hoexter and G Penfold Administrative Law in South Africa 3rd ed (2021) at 502. Footnote omitted.
16 Section 3 of the PAJA, in relevant parts, reads:
‘Procedurally fair administrative action affecting any person
(1) Administrative action which materially and adversely affects the rights or legitimate expectations of any
person must be procedurally fair.
(2)(a) A fair administrative procedure depends on the circumstances of each case.
(b) In order to give effect to the right to procedurally fair administrative action, an administrator, subject to

subsection (4), must give a person referred to in subsection (1) –
(i) adequate notice of the nature and purpose of the proposed administrative action;
(ii) a reasonable opportunity to make representations;
(iii) a clear statement of the administrative action;
(iv) adequate notice of any right of review or internal appeal, where applicable; and
(v) adequate notice of the right to request reasons in terms of section 5.’

15

[36] The Constitutional Court has held that fairness must be determined in light
of the specific circumstances of a particular case. 17 As me ntioned, the IPA
complained about the timing of the publication of Board Notice 71. It said that it
was inopportune, as it occurred during the Covid-19 pandemic, when its members
were engaged in the fight against the pandemic . The IPA also lamented the
method of publication, ie only in the Government Gazette.

[37] As to the timing argument, it is worth noting that the IPA was not the only
interested party to whom Board Notice 71 was directed. Despite the timing of the
notice, other interested bodies were able to review and comment on its contents.
The SAPC specifically mentioned responses from Clicks Retailers (Pty) Ltd, the
Western Cape Department of Health , the Independent Community Pharmacy
Association, the Pharmaceutical Society of South Africa National Office, and
S Buys Academy (Pty) Ltd. The IPA criticised the quality of some of the
comments. However, this does not detract from the fact that these entities
responded to the notice, and nothing about the timing of the notice prevented
them from doing so.

[38] The high court correctly observed that the IPA is a juristic person separate
from its members. There is no suggestion that the COVID-19 pandemic also
paralysed its administrative functions such that it could not respond to the
invitation in Board Notice 71 to make representations. The period within which
comments and representations were to be made was 60 days, which, to my mind,
was adequate. The IPA conceded that its comments were submitted well after the

17 Zondi v MEC for Traditional and Local Government Affairs and Others [2004] ZACC 19; 2005 (3) SA 589
(CC); 2005 (4) BCLR 347 (CC) para 114; Janse van Rensburg and Another v Minister of Trade and Industry and
Another [2000] ZACC 18; 2001 (1) SA 29; 2000 (11) BCLR 1235 (CC) para 24. Minister of Public Works and

Others v Kyalami Ridge Environmental Association and Another (Mukhwevho Intervening) [2001] ZACC 19;
2001 (3) SA 1151 (CC); 2001 (7) BCLR 652 (CC) para 10 2; Premier, Province of Mpumalanga, and Another v
Executive Committee of the Association of State-Aided Schools, Eastern Transvaal [1998] ZACC 20; 1999 (2) SA
91 (CC); 1999 (2) BCLR 151 (CC) para 39; and President of the Republic of South Africa and Others v South
African Rugby Football Union and Others [1999] ZACC 11; 2000 (1) SA 1 (CC); 1999 (10) BCLR 1059 (CC)
para 219.

16

prescribed period, and after the publication of the board notice through which
PIMART was implemented.

[39] There is no suggestion that the notice only came to the attention of IPA or
its members after the 60 days allowed for comments. The fact is that the IPA and
its members, like all the other interested role players, were given sufficient notice
of the introduction of PIMART through publication in the Gazette. Remarkably,
the IPA does not suggest that the notice did not come to its attention or its
members. As the Constitutional Court explained in Law Society of South Africa v
President of the Republic of South Africa, 18 procedural fairness requires that a
party likely to be disadvantaged by the outcome of a decision be given an
opportunity to be properly represented and fairly heard before a potentially
prejudicial decision is made.

[40] The IPA called in aid Joseph. In that case, a municipality disconnected the
electricity supply to a block of flats without giving the tenants any notice or an
opportunity to make representations before the disconnection. The court found
that this lacked procedural fairness, which directly affected the tenants’ access to
a basic service vital for their daily lives and dignity. The circumstances are
different here. The SAPC demonstrated procedural fairness by publishing Board
Notice 71 for public comment within 60 days. The process included adequate
notice and an opportunity for stakeholders to participate, meeting the
requirements of procedural fairness under s 3 of the PAJA.

[41] Regarding the method argument, the SAPC published Board Notice 71 on
its website and in the Gazette. It seems undisputed that these are the methods by
which the SAPC usually publishes new regulations. While publication on its

18 Law Society of South Africa and Others v President of the Republic of South Africa and Others [2018] ZACC
51; 2019 (3) BCLR 329 (CC); 2019 (3) BCLR 329 (CC); 2019 (3) SA 30 (CC) para 64.

17

website appears to be discretionary, publication in the Gazette is legislatively
required by s 49 of the Pharmacy Act. The section authorises the Minister, in
consultation with the SAPC, to make regulations on various matters related to the
pharmacy profession. Of relevance, for present purposes, is s 49(4), under which
Board Notice 71 was published. It reads:
‘The council shall, not less than two months before any rule is made in terms of this Act, cause
the text of such rule to be published in the Gazette together with a notice declaring the council’s
intention to make such a rule and inviting interested persons to furnish the council with
comments thereon or any representations they may wish to make in regard thereto.’

[42] Thus, by publishing Board Notice 71 in the Gazette, the SAPC fulfilled its
statutory obligation under s 49(4). However, according to the IPA, this was not
enough. It contended that compliance with s 3 of the PAJA ‘compels procedural
fairness, which, given the facts and circumstances [of the case], exceeded mere
compliance with a minimum statutory requirement in a post-constitutional era’.
The IPA suggested that to achieve its stated goal of ‘broad -based stakeholder
consultation’, the SAPC should have taken more comprehensive steps to consult
with medical practitioner s. Board Notice 71 should, for example, have been
published in a doctor’s journal for it to ‘reach the broadest possible readership of
medical doctors’.

[43] The IPA has not challenged the validity of the Pharmacy Act or the
provisions of s 49(4) on the ground that its notification procedure is inadequate
or inconsistent with the PAJA. Therefore, in the absence of a challenge to the
underlying legislation, it is not open to the IPA to argue that the introduction of
PIMART by publication, pursuant to s 49(4) was insufficient. In the result, once
the SAPC complied with s 49(4), it fulfilled its statutory obligation, and there was

the SAPC complied with s 49(4), it fulfilled its statutory obligation, and there was
no further legal requirement. I therefore conclude that the SAPC adhered to
procedural fairness requirement.

18

Rationality
[44] The IPA did not rely on this ground of review in its founding papers. It
introduced it in its notice of appeal and elaborated on it, in its heads of argument.
As a result, the SAPC did not have an opportunity to respond to this ground in its
papers in the high court . Despite this, the SAPC has not suffered any prejudice .
There is sufficient factual background in its founding affidavit regarding the
development of PIMART, upon which procedural rationality can be assessed.

[45] Where an administrative ‘decision is challenged on the grounds of
rationality, courts must examine the means chosen to determine whether they are
rationally connected to the objective sought to be achieved’.19 In Albutt v Centre
for the Study of Violence and Reconciliation (Albutt),20 the Constitutional Court
emphasised that ‘the purpose of the enquiry is to determine [not] whether the
means selected are rationally related to the objective sought to be achieved ’,21
rather than whether other means could have been used.

[46] In Democratic Alliance v President of South Africa, 22 after reviewing some
of its earlier decisions on rationality, including Albutt, the Constitutional Court
stressed that rationality review is concerned with the evaluation of a relationship
between means and ends: the relationship, connection or link between the means
employed to achieve a particular purpose on the one hand and the purpose or end
itself. It further explained:
‘The aim of the evaluation of the relationship is not to determine whether some means will
achieve the purpose better than others but only whether the means employed are rationally
related to the purpose for which the power was conferred. Once there is a rational relationship,
an executive decision of the kind with which we are here concerned is constitutional.’

19 Albutt v Centre for the Study of Violence and Reconciliation and Others [2010] ZACC 4; 2010 (3) SA 293
(CC); 2010 (2) SACR 101 (CC); 2010 (5) BCLR 391 (CC) para 51.
20 Ibid.

(CC); 2010 (2) SACR 101 (CC); 2010 (5) BCLR 391 (CC) para 51.
20 Ibid.
21 Ibid.
22 Democratic Alliance v President of South Africa and Others [2012] ZACC 24; 2013 (1) SA 248 (CC); 2012
(12) BCLR 1297 (CC).

19

[47] The IPA’s argument on procedural rationality should be assessed in light
of the factual background preceding the introduction of PIMART by the SAPC,
which I have outlined in some detail. In summary, the SAPC justified the
rationale for implementing PIMART as f ollows. Despite previous efforts to
reduce new HIV infections , such as NIMART and PIT , new infection rates
remained high. As a result, the department decided to involve pharmacists, among
other medical professionals, because their accessibility allows them to deliver
first-line HIV treatment, particularly in rural areas. This accessibility is
particularly important, as th e unchallenged evidence before the Court is that
millions of people in the rural areas of South Africa remain undiagnosed and
untreated for HIV.

[48] PIMART was thus a crucial intervention in the public interest, devised by
a group of medical experts. These included the HIV Clinicians Society, a team of
healthcare professionals heavily involved in caring for and treating people living
with HIV/AIDS. What is more, its development involved designing specialised
training programmes for pharmacists to enable them to provide PIMART
services.

[49] Thus, through PIMART, the SAPC aimed to improve access to healthcare
for HIV first -line treatment, given the inadequacy of previous initiatives.
PIMART was rationally connected to that objective, as it promotes the right to
access healthcare and supports the fight against HIV. Therefore, contrary to the
IPA’s contentions, PIMART is an essential intervention in the fight against
HIV/AIDS. Its introduction constitutes a rational legislative and practical
measure within the competence of the SAPC as an organ of the State in enhancing
access to healthcare for HIV treatment , in fulfilment of the State ’s obligation

20

under s 27(2) of the Constitution. 23 These are legitimate and compelling public
interests. Viewed in this light, PIMART is eminently rational. It follows that there
is no merit in IPA’s submissions on procedural rationality.

Rationality under s 6(2) of the PAJA
[50] Although in its papers the IPA raised several issues under this rubric, in
this Court, it focused mainly on two, with which I deal in turn. First, it emphasised
the distinct professional domains of pharmacists and medical doctors as regulated
by the Pharmacy Act and the Health Professions Act 56 of 1974 (the Health
Professions Act), respectively. Based on that distinction, the IPA argued that the
decision to implement PIMART was not authorised by the empowering
provisions of these Acts, thereby breaching s 6(2)(e)(i). The IPA contended that
these statutes do not permit the SAPC to expand the scope of a pharmacist’s
treatment to include PIMART, as this would encroach upon the professional
domain of medical practitioners (the encroachment issue).

[51] Second, the IPA contended that the implementation of PIMART conflicted
with existing legislation, namely, the Medicines Act and the Health Professions
Act, in violation of s 6(2)(f)(i). According to the IPA, the effect of these statutes
is that pharmacists are not authorised to diagnose or treat diseases, as that ‘is
expressly beyond a pharmacist’s scope of practice. .’. The IPA further argued that
a pharmacist lacks the clinical training and experience to initiate and manage a
patient on HIV/AIDS therapy, nor the clinical expertise to monitor the patient’s
outcomes (legislation contravention issue).




23 Section 27(1)(a) and (2) mandates that ‘the [S]tate must take reasonable legislative and other measures, within
its available resources, to achieve the progressive realisation’ of the right to, inter alia, ‘health care services’.

21

The encroachment issue
[52] The IPA’s concerns are based on the notion that PIMART serves as a
blanket licence for pharmacists to treat HIV patients. It does not. As mentioned,
PIMART’s scope is limited and applies only to accredited pharmacists. It is
restricted to prevention, first-line antiretroviral therapy, and the initiation of TPT
for uncomplicated, non -immunocompromised HIV -positive individuals, in
accordance with the department’s guidelines.

[53] The PIMART scope of practice includes three main categories. Part (a)
covers screening and confirmatory tests. Parts (b) to (f) mainly involve dispensing
PrEP and PEP, limited to patients who are at least 15 years old and not pregnant.
The treatment involves prescribing preventive medication, specifically initiating
and managing first -line antiretroviral therapy, following clearly defined and
evidence-based protocols. Parts (g) and (h) allow for referral to another healthcare
provider when needed, along with maintaining confidential records.

[54] Thus, the introduction of PIMART will not alter the scope of practice of
medical practitioners involved in treating HIV/AIDS. The fact is that medical
practitioners do not have exclusive rights to care for people living with
HIV/AIDS. As evidenced by the background facts, this is a collaborative effort
involving various health professionals.

Legislation contravention issue
[55] As mentioned, the IPA asserted that pharmacists are not authorised to
prescribe medicines under schedules 3, 4 and 5, based on s 22A of the Medicines
Act. The section provides for control of medicines, scheduled substances, medical
devices and in vitro diagnostics. In terms of s 22A(4), pharmacists may only offer
schedule 1 and 2 medicines without a prescription. They can offer Schedule 3

22

medicines in certain specified circumstances. For Schedule 4, 5, and 7 medicines,
pharmacists can only do so on prescription by a medical practitioner.24

[56] Section 22A(15) carves out an exception to the above provision , by
authorising the Director-General to issue permits to health practitioners other than
medical practitioners, authorising them to provide any of the scheduled
medicines. It provides:
‘Notwithstanding anything to the contrary contained in this section, the Director-General may,
after consultation with the Pharmacy Council of South Africa . . . issue a permit to any person
or organisation performing a health service, authorising such person or organisation to acquire,
possess, use or supply any specified Schedule 1, Schedule 2, Schedule 3, Schedule 4 or
Schedule 5 substance, and such permit shall be subject to such conditions as the Director -
General may determine.’

[57] This is the provision that the Director -General used to allow PIMART-
accredited pharmacists to apply for permits to prescribe substances classified as
Schedule 3-5. The IPA disregards this provision in its argument that expanding a

24 Section 22A(4) of the Medicines Act reads:
‘Any Schedule 1 substance shall not be sold-
(a) by any person other than-
(i) a pharmacist, or a pharmacist intern or pharmacist’s assistant acting under the personal
supervision of a pharmacist;
(ii) a manufacturer of or wholesale dealer in pharmaceutical products for sale to any person who
may lawfully possess such substance;
(iii) a medical practitioner or dentist, who may-
(aa) prescribe such substance;
(bb) compound and dispense such substance only if he or she is the holder of a licence as
contemplated in section 22C (1) (a);
(iv) a veterinarian who may prescribe, compound or dispense such substance;
(v) a practitioner, nurse or a person registered under the Health Professions Act, 1974, other than a
medical practitioner or dentist, who may-

medical practitioner or dentist, who may-
(aa) prescribe only the Scheduled substances identified in the Schedule for that purpose;
(bb) compound and dispense the Scheduled substances referred to in item (aa) only if he or she is the
holder of a licence contemplated in section 22C (1) (a);
(b) to any person apparently under the age of 12 years except upon a prescription issued by an authorised
prescriber and dispensed by a pharmacist, pharmacist intern or pharmacist's assistant or by a veterinarian or a
person who is the holder of a licence as contemplated in section 22C (1) (a), or on a written order disclosing the
purpose for which such substance is to be used and bears a signature known to the seller as the signature of a
person known to such seller and who is apparently over the age of 12 years;
(c) unless the seller, other than a manufacturer or wholesale dealer in pharmaceutical products, enters in a
prescription book required to be kept in the prescribed manner, the prescribed particulars of such sale. ’

23

pharmacist’s scope conflicts with the Medicines Act. The Director-General acted
within the powers granted by this provision, the validity of which the IPA has not
challenged. Therefore, in the absence of a challenge to this empowering
provision, the IPA’s arguments about the unsuitability of pharmacists prescribing
Schedule 3, 4, and 5 substances are futile.

The IPA’s residual arguments
[58] The IPA argued that in adopting and implementing PIMART, the SAPC:
(a) considered irrelevant factors in breach of s 6(2)(e)(ii); (b) acted arbitrarily or
capriciously in contravention of s 6(2)( e)(vi); (c) had no rational connection to:
(i) the purpose for which it was taken; (ii) the purpose of the empowering
provision; (iii) the information before the SAPC; and (d) failed to provide reasons
when requested to do so.

[59] As mentioned, PIMART was an initiative created in response to a
persistent rise in new HIV infection rates, despite previous efforts. The SAPC, at
the department’s request, deemed PIMART suitable for addressing this issue. As
the high court correctly found, the SAPC evaluated the risks associated with
pharmacists initiating first -line ART and TPT, as well as providing PrEP and
PEP, and considered these risks when deciding to approve the PIMART training
course. The uncontested evidence presented by the SAPC demonstrates that the
approved accreditation process for PIMART was rigorous and thorough.

[60] Considering all these factors, it cannot reasonably be argued that the SAPC
disregarded relevant considerations or failed to consider important ones.
Furthermore, there is no basis to claim that the SAPC acted arbitrarily or
capriciously. There clearly was a rational connection between PIMART and its
purpose, which was to expand access to first-hand HIV therapy, authorised by the
Pharmacy Act. The information available to the SAPC indicated that HIV

24

infection rates were rising. It also identified pharmacists as being well-positioned
to provide the first line of HIV therapy. Therefore, the implementation of
PIMART was grounded in the information before the SAPC.

[61] I turn to the IPA’s complaint that the SAPC failed to furnish it with reasons
for its decisions when requested to do so. Section 5(3) of the PAJA provides:
‘If an administrator fails to furnish adequate reasons for an administrative action it must,
subject to subsection (4) and in the absence of proof to the contrary, be presumed in any
proceedings for judicial review that the administrative action was taken without good reason.’

[62] This provision establishes a rebuttable presumption that if an administrator
does not provide reasons for its decision, it was made without good cause. The
burden is on the administrator in subsequent review proceedings to rebut this
presumption. In the pr esent case, the SAPC has clearly discharged that burden,
and the IPA’s counsel, correctly, did not assert otherwise.

[63] The IPA also complained about the high court’s finding that publishing the
adoption of PIMART in the Gazette was not a statutory requirement . The high
court referenced s 35A (b) of the Pharmacy Act, which authorises the SAPC to
make rules related to pharmacists. The court stated that since PIMART does not
fall under the category of ‘rules’ specified in s 35A(b), there was no obligation to
publish its implementation. Nothing turns on this finding, as, despite it, the high
court concluded that the publication met the procedural fairness requirement.
Besides, it is settled that an appeal does not lie against the reasons for judgment
but against the substantive order of the lower court.25 It is immaterial whether we
agree with the high court’s reasoning on this issue, since the result of the appeal
remains the same.26

25 ABSA Bank Ltd v Mkhize, Absa Bank Ltd v Chetty; Absa Bank Ltd v Mlipha [2013] ZASCA 139; [2014] 1 All

SA 1 (SCA); 2014 (5) SA 16 (SCA) para 64.
26 Western Johannesburg Rent Board v Ursula Mansions (Pty) Ltd 1948 (3) SA 353 (A) at 354.

25

[64] In all the circumstances, the appeal must fail. Costs should follow the
result. The following order is made:
The appeal is dismissed with costs, including the costs of two counsel.
_____________________
T MAKGOKA
JUDGE OF APPEAL

26

Appearances:
For appellant: J C Uys SC (with him TB Mirtle)
Instructed by: Brand Potgieter Inc., Johannesburg
Lovius Block Inc., Bloemfontein

For respondent: B E Leech SC (with him S L Mohapi)
Instructed by: Werksmans Inc., Johannesburg
Symington & De Kok, Bloemfontein.