Nursing Scope under the Nursing Act (2005): In South Africa, only registered nurses with the appropriate qualifications may diagnose or prescribe. Under Section 31(1) of the Nursing Act (Act 33 of 2005), a Nurse Practitioner (NP) – a registered professional nurse with an additional post-basic qualification – may be registered by the South African Nursing Council (SANC) to “assess, diagnose, prescribe treatment, keep and supply medication for prescribed illnesses and health-related conditions”[1]. This registration requires proof of the prescribed training and payment of fees[1]. Crucially, Section 56(6) authorizes specific nurses in the public sector to prescribe on limited grounds: it permits nurses employed by national or provincial health departments (or DG‑designated organisations) to “keep prescribed medicines and their supply, administering or prescribing on the prescribed conditions” – but only when they are explicitly authorised by the Director-General (or equivalent) and a medical practitioner or pharmacist is not available[2]. In practice this means nurse prescribing per Section 56(6) is confined to government clinics (or DG‑designated health facilities) and to drugs listed in the PHC Standard Treatment Guidelines. SAPC guidance confirms that only nurses in designated public facilities may prescribe (for example, in HIV care via NIMART) and that pharmacists must verify any nurse prescription against these authorisations[3]. By contrast, nurses in private facilities have no independent prescribing rights under current law. Importantly, the Nursing Act requires any nurse prescribing to be within the scope approved by SANC; in fact, Section 22A(14)(b) of the Medicines Act (below) specifically states that “no nurse… may prescribe a medicine or scheduled substance unless he or she has been authorised to do so by [SANC]”[4].
Medicines Act (1965) – Section 22A Permits: The Medicines and Related Substances Act (Act 101 of 1965) governs possession and supply of medicines. Section 22A(15) empowers the Director-General of Health – after consulting the Pharmacy Council – to issue special permits to “any person or organisation performing a health service” authorising them to acquire, possess, use or supply specified Schedule 1–5 medicines[5]. These permits are designed for public health initiatives (e.g. nurse immunisations, family planning, minor ailments) and do not override normal prescribing rules. In other words, a 22A(15) permit lets nurses or others stock and dispense listed drugs (for example vaccines) under specific programmes, but it does not make the holder an “authorised prescriber” able to write prescriptions for dispensing at a pharmacy[6]. Section 22A(16) further clarifies that any person may lawfully possess Schedule 0–2 medicines (own use) and Schedule 3–6 only with a valid prescription[7]. It also explicitly allows a medical practitioner, dentist, veterinarian, “practitioner, nurse” or other health professional to possess any medicine for the purpose of administering it within their scope[8]. This means a nurse may hold and give a drug to a patient under treatment (e.g. administer an antiretroviral) if it falls in her scope, but she still may not issue a pharmacy prescription for a new supply of that drug unless properly licensed. In short, Section 22A(15) permits are about logistics (keeping stock for public health services), and Section 22A(16)(c) confirms that nurses may administer medicines consistent with their authorized scope[8].
Pharmacy Act (1974) and Pharmacist Scope: The Pharmacy Act defines pharmacy practice and vests in the SAPC the power to determine pharmacists’ duties. Pharmacists must be registered with SAPC and may only perform acts “specially pertaining to the scope of practice of a pharmacist”[9]. Traditionally, pharmacists dispense prescriptions and provide counselling. Pharmacist-initiated prescribing has only recently been enabled for HIV care. In 2021, SAPC issued Board Notices 17 (for comment) and 101 (for implementation) to establish Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART). Board Notice 101 (August 2021) amends pharmacists’ scope to allow trained pharmacists to assess patients, conduct HIV testing, and initiate first-line ARVs (PrEP, PEP, and first-line treatment) per NDOH guidelines[10]. Specifically, a PIMART-trained pharmacist may take sexual histories, test for HIV/STIs, and “initiate anti-retroviral treatment limited to PrEP, PEP and 1st line ART plus initiation of TB-preventative therapy”[11]. They may also adjust previously prescribed ART, monitor treatment outcomes, and make referrals as needed[10]. Importantly, this expanded role applies in community pharmacies (private sector) under DG-issued PIMART permits (Section 22A(15) of the Medicines Act).
NIMART vs. PIMART (public vs. private): Nurse Initiated Management of ART (NIMART) was introduced by the National Department of Health around 2010 as a public-sector HIV care strategy. Under NIMART, nurses in clinics (with Section 56(6) authorization and NDOH training) may start and monitor ART in lieu of doctors[12]. NIMART is explicitly a public program; private nurses cannot enroll without DG-designated status. By contrast, Pharmacist-Initiated Management of ART (PIMART) is aimed primarily at community pharmacists (mostly private sector). As the SCA summarized, PIMART is a “government-initiated intervention” that accredits pharmacists to deliver first-line HIV treatment[13]. Like NIMART, PIMART requires supplementary training and regulatory approval, but its legal basis is the SAPC’s scope rules (via Pharmacy Act regulation and 22A(15) permits). Thus NIMART is confined to public clinics (designated under Sec.56(6)), whereas PIMART enables trained pharmacists in the private sector to provide PrEP/PEP/first-line ART under a 22A permit[13][11].
Key Court Rulings: In IPA Foundation (NPC) v South African Pharmacy Council, both the High Court (North Gauteng, Pretoria) and the Supreme Court of Appeal addressed challenges to PIMART. In 2023 the High Court held that SAPC followed fair process (publishing BN 17/2021 and BN 101/2021) in creating PIMART and that it was rational to enable pharmacists to support HIV care[14][15]. The SAHDA (Supreme Court of Appeal) later dismissed the appeal in Oct 2025, upholding PIMART. The SCA reiterated that SAPC had lawfully amended pharmacists’ scope and that DG-issued PIMART permits (under Medicines Act 22A(15)) validly authorize pharmacists to initiate HIV therapy[13][16]. In essence, these judgments confirm that specially trained pharmacists with PIMART accreditation and a 22A(15) permit may prescribe selected ARVs.
Privacy, Consent, and Continuity of Care
Privacy and Confidentiality: South African law firmly protects patient privacy. Section 14 of the Constitution guarantees everyone’s right to privacy[17], which courts interpret to include control over personal and health information. The Protection of Personal Information Act (POPIA, 2013) implements these constitutional principles: it requires that personal health data be collected and processed lawfully, with consent or other legal basis[18]. Healthcare professionals must keep patient information confidential, disclosing it only as permitted by law or with patient consent. The HPCSA’s ethical guidelines (Booklet 5, Confidentiality: Protecting and Providing Information) similarly bind pharmacists and nurses to maintain confidentiality. For example, disclosure of an HIV-positive status or treatment regimen requires the patient’s informed consent or a legal obligation (e.g. reporting). In practice, pharmacies and clinics must store records securely and share patient data (e.g. with other providers) only through legitimate channels.
Informed Consent: Informed consent is a legal and ethical prerequisite to treatment. The National Health Act (Act 61 of 2003) and HPCSA guidelines require that patients be given full information about their health, the nature and purpose of any procedure or medication, alternatives (including refusal), and the risks and benefits before consenting to care[19]. A patient’s consent must be voluntary, adequately documented, and specific to the service. For HIV testing or prescribing PrEP/PEP/ART, providers must ensure that individuals understand the process and implications. HPCSA’s Guidelines on Seeking Patients’ Informed Consent (Booklet 4) reinforce that nurses and pharmacists must explain treatment and obtain consent in clear language. Crucially, Section 8 of the NHA guarantees patients the right to informed consent, and patients can refuse treatment at any time without penalty.
Continuity of Care: South African standards emphasize smooth transitions between providers. The NHA and HPCSA’s Patients’ Rights Charter enshrine the right to continuity of care, meaning providers must not abandon patients and should make appropriate referrals. For example, if a nurse or pharmacist cannot manage a patient’s condition, they must refer to a doctor or specialist. Regulations also require proper recordkeeping: a patient’s medication history and lab results must be documented to support ongoing care. For HIV treatment, this means pharmacists extending ART must coordinate with clinics (often via the Central Chronic Medicine Dispensing and Distribution program) to ensure the patient’s overall care plan continues seamlessly. Under HPCSA guidelines, both nurses and pharmacists share the responsibility of follow-up; for instance, a pharmacist initiating PrEP must arrange for quarterly HIV/STI tests, per standard protocols.
International Comparisons in HIV Care Delivery
South Africa’s models fit into a global trend of expanding non-physician roles to increase HIV service access. Key comparisons include:
- South Africa: Nurses (in public PHC) use NIMART to initiate and manage ART; pharmacists (in community/private sector) use PIMART (with permits) to prescribe PrEP/PEP and first-line ART[11]. These roles are strictly defined by SANC and SAPC regulations (Nursing Act and Medicines Act).
- United States: Nurse Practitioners (NPs) enjoy broad prescriptive authority nationwide, including antiretrovirals; many state laws allow independent NP prescribing. Pharmacists’ roles vary by state. For example, California’s Senate Bill 159 (2019) permits pharmacists to dispense PrEP/PEP directly without a physician’s prescription[20]. More generally, pharmacists in several U.S. jurisdictions can prescribe PrEP under collaborative practice agreements or standing orders. Studies note that in pharmacy-led PrEP programs, “under some jurisdictions… pharmacists may gain authorization to prescribe PrEP and… order tests”[21].
- United Kingdom: Pharmacist and nurse independent prescribing were legalized in 2006. Appropriately trained nurse prescribers and pharmacist independent prescribers can manage HIV medications (e.g. issue PrEP/PEP) as part of multidisciplinary care. (Practically, HIV care tends to remain centralized in specialist clinics, but primary care prescribers—including practice nurses and pharmacists with independent prescriber status—are recognized by guidelines.)
- Australia: Nurse Practitioners are autonomous prescribers; by law, any registered medical practitioner or nurse practitioner can prescribe PrEP[22]. Pharmacists generally do not have broad independent prescribing rights, but they provide expanded services (e.g. pharmacy PrEP pilot studies exist). The Australasian HIV guidelines explicitly note that nurse practitioners can directly write PrEP scripts[22], indicating high-level recognition of nurse roles in prevention.
- Canada: Provincial regulations vary. British Columbia (2023) expanded pharmacists’ scope to include many minor ailments and some infectious diseases (e.g. “COVID-19, influenza, sexually transmitted and blood borne infections”[23]). Ontario and other provinces allow pharmacists to run PrEP clinics: reviews report that “PrEP prescription by pharmacists is the most common intervention” in pharmacy-led programs[24]. Some provinces (e.g. Alberta, Ontario) explicitly permit pharmacists to prescribe antimicrobials and certain HIV-related therapies under protocol, whereas Canadian nurse practitioners generally have full prescribing rights including ART.
These comparisons underscore that task-shifting HIV services to trained nurses and pharmacists is a proven strategy internationally. Notably, countries like the US and Australia already allow non-physician prescribers to initiate and manage PrEP/ART, and Canada’s pharmacists are taking on PrEP delivery roles[24][22].
Summary Table: South Africa vs International Practices
| Country/Region | Nurse Prescribing (HIV Care) | Pharmacist Prescribing (HIV Care) | Key Regulations/Guidelines |
| South Africa | Public sector only: Nurses with SANC-approved post-basic qualifications (Nurse Practitioners or those authorized under s56(6) in DG-designated facilities) may prescribe ART according to PHC protocols[2][3]. Private nurses have no independent prescribing rights. | Private sector (community pharmacies): Pharmacists who complete PIMART training and obtain a DG-issued 22A(15) permit may prescribe PrEP, PEP, and first-line ART (as per Board Notice 101)[11][5]. | Nursing Act 33/2005 s56; SANC regulations; Medicines Act 101/1965 s22A(15-16); SAPC Board Notice 101/2021 (PIMART scope)[2][11]. |
| USA | Varies by state, but most allow Nurse Practitioners full prescriptive authority (including ART/PrEP) under state law. HIV-specialty NP training is common. | Varies by state. Some states allow pharmacists to prescribe PrEP/PEP under standing orders or collaborative practice (e.g. California’s SB 159)[20]. Many states permit limited pharmacist prescribing (e.g. vaccines, contraception) by law or protocol. | State Nurse Practice Acts; federal/state pharmacy laws; example: California SB 159 (2019) for PrEP[20]; CDC/NIH PrEP guidance. |
| United Kingdom | Independent prescribing by nurse and pharmacist is permitted (since 2006). Qualified nurse prescribers manage HIV meds in specialized and some primary care settings. | Pharmacist Independent Prescriber (since 2006) can manage chronic HIV care and prescribe PrEP/PEP under NHS protocols. Some pharmacy clinics offer sexual health screening and PrEP (though NHS commissioning varies). | NHS Professional Standards; Human Medicines Regulations 2012 (UK); NHS clinical guidelines (BHIVA, PHARM). |
| Australia | Nurse Practitioners have full prescriptive rights, including ART/PrEP (no special specialist endorsement required)[22]. Nurses in special clinics may also follow shared-care protocols. | Pharmacists may not generally prescribe ART, but they provide referrals for PrEP. Some jurisdictions pilot pharmacy PrEP models. Vaccinations and some sexual health services are allowed in pharmacies by regulation. | Health Practitioner Regulation National Law; PBS guidelines for PrEP (e.g. ASHM PrEP guidelines); state immunization/pharmacy scope rules. |
| Canada | NPs in all provinces can prescribe ART/PrEP. Provincial HIV care guidelines include NP-led care. | Pharmacist scope is province-specific. In BC and other provinces, pharmacists can prescribe for minor ailments including certain infections (as of 2023)[23]. Many provinces allow pharmacists to deliver PrEP under protocol or collaborative models[24]. Some pharmacists run PrEP clinics. | Provincial pharmacy acts/regulations; Canadian PrEP guidelines (CCRT/PHAC); e.g. Ontario Pharmacist Prescribing Policy; Alberta Pharmacists’ Prescribing Standard for STIs. |
Key Takeaways: In South Africa’s private sector, nurses can dispense and administer medicines (with patient consent) but may only initiate HIV treatment under strict regulatory exceptions (public sector S56(6) authorizations). Pharmacists in the private sector can initiate HIV prevention/treatment only via the PIMART framework (required training, 22A(15) permit, and ongoing consultation with doctors as needed). Risk management in this context means strictly adhering to these legal limits: pharmacists must verify any nurse-issued prescription (per the Medicines Act and SAPC advisories[25]), and nurses must refrain from prescribing outside their authorised programs. Finally, every healthcare professional must uphold legal duties of confidentiality (Constitution S14; POPIA) and informed consent (National Health Act and HPCSA ethics) and ensure seamless care transitions for the patient.
Sources: Provisions of the Nursing Act, Medicines Act (Sections 22A(15-16)), and relevant regulations; SAPC practice advisories and Board Notices[2][4][11]; the IPA Foundation High Court and SCA decisions (2023/2025)[14][13]; SANC/SAPC guidelines; HPCSA ethical guidelines on consent/confidentiality[26][17]; and international pharmacy/nursing regulatory reports[20][22][24].
[1] [2] Nursing Act [No. 33 of 2005]
https://www.gov.za/sites/default/files/gcis_document/201409/a33-050.pdf
[3] [6] [25] pharmcouncil.co.za
https://www.pharmcouncil.co.za/Media/Default/Documents/Stakeholder%20Communication/Binder1.pdf
http://www.acts.co.za/medicines-/22a__control_of_medicines_and_scheduled_substances
[9] pharmcouncil.co.za
https://www.pharmcouncil.co.za/Media/Default/Pharmacy%20Act/Pharmacy%20Act%2053%20of%201974.pdf
[10] [11] 101: Rules Relating to the services to which a Pharmacist may levy a fee
https://pharmcouncil.co.za/Media/Default/Documents/BN101_2021_PIMART_implementation.pdf
[12] [20] Pharmacist-initiated management of antiretroviral therapy (PIMART)
http://www.scielo.org.za/scielo.php?script=sci_arttext&pid=S0256-95742021001200003
[13] [14] [15] [16] media.lawlibrary.org.za
[17] [18] The Protection of Personal Information Act 4 of 2013 in the Context of Health Research: Enabler of Privacy Rights or Roadblock?
http://www.scielo.org.za/scielo.php?script=sci_arttext&pid=S1727-37812022000100008
[19] Microsoft Word – 9 Booklet 9 Informed Consent.doc
[21] [24] Delivery models of pharmacy-led HIV pre-exposure prophylaxis (PrEP) – The Ontario HIV Treatment Network
[22] PrEP Guidelines_Final
https://ashm.org.au/wp-content/uploads/2024/01/ASHM-Health_PrEP-Guidelines.pdf
[23] Rapid evidence synthesis: Impacts of pharmacist prescribing on the equity-centred quadruple-aim outcomes
[26] New and Updated Ethical Guidelines –
https://www.hpcsa-blogs.co.za/new-and-updated-ethical-guidelines/
