The Pretoria High Court upheld the South African Pharmacy Counsel’s decision to implement the Pharmacist-Initiated Management of Antiretroviral Treatment programme allowing suitably qualified pharmacists with the necessary permits in term of section 22A(15) of the Medicines and Related Substances Act, 1965, to prescribe Pre-Exposure and Post-Exposure Prophylaxes (more commonly known as PrEP and PEP), first-line antiretroviral therapy, and TB-preventative therapy to patients. The decision was unsuccessfully challenged by the Independent Practitioner Association Foundation. 

Even before the programme was implemented, qualified pharmacists could consult with, diagnose and manage patients, and prescribe certain medication like post exposure (or needle-stick) HIV prophylaxis to healthcare workers and emergency contraceptives.   

Given the high rates of HIV infection in South Africa and the World Health Organisation’s recommendation that all people living with HIV be provided with antiretroviral treatment, the Department of Health requested the SAPC to consider and implement a programme to provide increased access to ARVs. The SAPC then formulated, published, and implemented the programme. 

IPA argued that the SAPC had failed to allow interested parties adequate opportunity to comment on the programme before it was implemented, and that in implementing the programme, the SAPC had unjustifiably and irrationally extended pharmacists’ scope of practice to encroach on that of medical practitioners, and to an extent that was not allowed for by legislation. 

Although the Medicines Act allows pharmacists to sell schedule 4, 5, and 7 substances only on prescription by a medical practitioner, section 22A(14)(b) allows healthcare professionals, other than medical practitioners, to be approved as authorised prescribers.

SAHPRA’s guidelines on prescribing by authorised prescribers provide guidance on amending the Schedules to the Medicines Act to allow prescription rights to authorised health professionals, other than medical practitioners, in accordance with section 22A. This, in the court’s view, indicates that health professionals, other than medical practitioners, can be authorised to prescribe scheduled substances. 

The court noted that, in approving such prescribers, the Director General may seek advice from SAHPRA, but is not restricted from making individual determinations for specific circumstances, and is not required to ask for input from the HPCSA when section 22A(15) permits are applied for. 

While regulation 2 of the HPCSA’s Regulations defining the scope of the profession of medicine deems clinical examination and diagnosis to be acts pertaining to the medical profession, regulation 3 makes it clear that this does not prohibit any person registered under healthcare legislation from performing any act in accordance with that legislation. 

The Pharmacy Act, 1974 empowers the SAPC to prescribe the scope of practice of various categories of persons registered under that Act. The Minister of Health is then empowered to determine the scope of practice of pharmacy. In Minister, in consultation with the SAPC, promulgated the Regulations Relating to the Practice of Pharmacy, to include a list of acts regarded as specifically pertaining to the pharmacy profession. This list includes the diagnosing of a patient’s health need and prescribing and supplying medicine to meet that need. 

The court found that there was nothing sinister in the way the SAPC had advertised its intention to introduce the programme and that the implementation of the programme fell within the SAPC’s legislative mandate. The decision to implement, and the subsequent implementation of the programme, was therefore found to be sound from an administrative law perspective. 

Perhaps unsurprisingly given the nature of the programme and its benefits, the court found that any alleged adverse effect the programme would have on medical practitioners must be considered against the need to expand primary health care services aimed at preventing and treating HIV and the court ultimately dismissed IPA’s application with costs.

You can access the case here.