The IPA Foundation (NPC) v South African Pharmacy Council

The IPA Foundation (IPA), a non-profit company representing family medical practitioners in private practice, challenged two decisions by the South African Pharmacy Council (SAPC). The SAPC approved the implementation of Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART) services, which would allow specially trained and accredited pharmacists to administer first-line HIV/AIDS treatment. This decision was published in Board Notice 101 of 2021 on 13 August 2021, following Board Notice 71 of 2021 published on 22 March 2021 which invited public comment within 60 days. The PIMART initiative arose from the Department of Health's request to the SAPC to investigate interventions to increase access to antiretroviral medicines. Despite initiatives like NIMART (Nurse-Initiated Management of Antiretrovirals) since 2010, HIV infection rates remained high, with 8.2 million people affected by 2010. The Department spent over R20 billion on HIV in 2019/2020. The SAPC published Board Notice 71 in the Government Gazette on 22 March 2021, inviting comments within 60 days. The IPA did not comment within this period, submitting objections only on 8 September 2021, after Board Notice 101 had been published. The IPA then brought a review application in the High Court challenging both the procedural fairness and substantive rationality of the SAPC's decisions.

• Whether the High Court correctly struck out portions of the IPA's replying affidavit containing new evidence
• Whether the IPA had standing to bring the review application
• Whether the SAPC's publication of Board Notice 71 in the Government Gazette was procedurally fair and complied with section 3 of the Promotion of Administrative Justice Act (PAJA)
• Whether the SAPC's decision to implement PIMART was rational and complied with section 6(2) of PAJA
• Whether PIMART exceeded the statutory powers of the SAPC under the Pharmacy Act 53 of 1974 and encroached on the professional domain of medical practitioners
• Whether PIMART conflicted with the Medicines and Related Substances Act 101 of 1965 and the Health Professions Act 56 of 1974
• Whether the SAPC's failure to provide reasons when requested constituted grounds for review under section 5 of PAJA

The appeal was dismissed with costs, including the costs of two counsel.

The binding legal principles established are: 1. **Procedural fairness through statutory publication:** Where enabling legislation prescribes a specific method of notification (such as publication in the Government Gazette with a specified comment period), compliance with that statutory requirement satisfies the procedural fairness obligations under section 3 of PAJA, provided the legislation itself has not been challenged as inadequate or unconstitutional. 2. **New matter in reply:** An applicant in motion proceedings cannot introduce substantive new evidence in a replying affidavit to bolster its case. Supporting affidavits that contain arguments in favor of the primary relief rather than rebuttal of the answering affidavit constitute impermissible new matter. An applicant must stand or fall by its founding affidavit. 3. **Rationality test in administrative law:** Administrative decisions are rational under PAJA when there is a rational connection between: (a) the means chosen and the objective sought to be achieved; (b) the decision and the purpose of the empowering provision; and (c) the decision and the information before the administrator. Courts do not assess whether alternative means might achieve the purpose better, only whether the means employed are rationally related to the purpose. 4. **Scope of regulatory powers:** Statutory health professional councils, acting within their enabling legislation, have authority to expand scopes of practice for registered professionals through delegated legislation where such expansion serves the statutory objectives of the council and public health interests, provided they follow prescribed procedures. 5. **Rebutting section 5(3) PAJA presumption:** While section 5(3) of PAJA creates a rebuttable presumption that failure to provide reasons means administrative action was taken without good reason, an administrator can rebut this presumption by providing adequate reasons and evidence in subsequent review proceedings demonstrating the decision was taken on good grounds.

The Court made several non-binding observations: 1. **COVID-19 pandemic and procedural fairness:** While the Court noted the IPA's argument about the timing of Board Notice 71 during the COVID-19 pandemic, it observed that the IPA as a juristic person separate from its members should have been able to fulfill administrative functions despite the pandemic. The fact that other stakeholders managed to respond demonstrated the adequacy of the notice period. 2. **Quality of stakeholder comments:** The Court noted the IPA's criticism of the quality of some comments received by the SAPC but observed this did not detract from the fact that the procedural fairness requirements were met through the opportunity provided to comment. 3. **Broader publication methods:** The Court acknowledged the IPA's argument that broader publication methods (such as in medical journals) might have reached more doctors, but noted this argument could not succeed absent a challenge to the adequacy of section 49(4) of the Pharmacy Act itself, which prescribes Gazette publication. 4. **Appeals against reasons vs. orders:** The Court reiterated the settled principle that an appeal lies against the substantive order of a lower court, not against the reasons for judgment. Even if the appellate court disagrees with the lower court's reasoning on a particular issue, if the result remains the same, the appeal cannot succeed on that basis. 5. **Multidisciplinary healthcare:** The Court observed that medical practitioners do not have exclusive rights to care for people living with HIV/AIDS, emphasizing that this is properly a collaborative effort involving various health professionals. This reflects a modern understanding of healthcare delivery as inherently multidisciplinary. 6. **Limited scope of PIMART:** The Court emphasized that PIMART is not a blanket license but is carefully limited to: accredited pharmacists; first-line therapy; uncomplicated, non-immunocompromised patients; patients 15 years and older who are not pregnant; and compliance with Department of Health guidelines, with referral mechanisms to other healthcare providers when needed.

This case is significant in South African administrative and health law for several reasons: 1. **Access to healthcare:** It affirms the state's constitutional obligation under section 27(2) to take reasonable legislative and other measures to progressively realize the right to access healthcare services. PIMART represents a rational measure to expand access to HIV treatment, particularly in underserved rural areas. 2. **Regulatory flexibility in public health emergencies:** The judgment demonstrates the scope of statutory health regulators like the SAPC to expand professional scopes of practice through delegated legislation to address public health challenges, provided they act within statutory powers and comply with procedural fairness requirements. 3. **Procedural fairness in administrative action:** The case clarifies that publication in the Government Gazette in accordance with enabling legislation satisfies procedural fairness requirements under PAJA. Where legislation prescribes a notification method, compliance with that method fulfills the administrator's obligations absent a challenge to the adequacy of the legislative provision itself. 4. **Standing in administrative law:** The judgment affirms the broad approach to standing under section 38 of the Constitution in administrative law matters, particularly where the challenge concerns an area central to the applicant's field of operation and involves important public interests. 5. **Rationality review:** The decision reinforces that rationality review examines whether means are rationally connected to the purpose sought to be achieved, not whether alternative means might be preferable. Courts should not second-guess policy choices where a rational connection exists. 6. **Interprofessional collaboration in healthcare:** The case recognizes that healthcare delivery, particularly for conditions like HIV/AIDS, is properly a collaborative, multidisciplinary endeavor rather than the exclusive domain of any single profession.