Specially trained and accredited pharmacists in South Africa will now be allowed to provide people with medicines to prevent HIV and tuberculosis (TB) and to treat uncomplicated HIV without a doctor's script. This is because the North Gauteng High Court this week ruled against an application by the IPA Foundation (an association of private doctors) attempting to block the implementation of Pharmacist-Initiated Management of Antiretroviral Therapy (PIMART).
PIMART involves the introduction of a legislative framework, a specialised training course, and an accreditation process to allow pharmacists to supply HIV and TB medicines to people visiting pharmacies, under certain conditions, without a doctor's script.
Spotlight will be in the GP division of the High Court today to cover a case likely to determine whether pharmacists in SA may prescribe ARVs and TB preventive therapy. Background here https://t.co/LMDcvBYujL #PIMART @catherinetom @SAHIVSoc @OfficialSAPC
-- Spotlight (@SpotlightNSP) May 23, 2023
The ruling in the case of IPA Foundation versus the South African Pharmacy Council (SAPC) was handed down by Judge Elmarie van der Schyff on 14 August 2023 - almost two years to the day exactly after legislation introducing PIMART was published by the SAPC. Board Notice 101 of 2021 was published on 13 August 2021 (at the time, Spotlight published an in-depth article on the case for PIMART).
... that while tension between healthcare cadres regarding their scopes of practice is common, the World Health Organization calls for 'a collaborative approach to primary healthcare issues and the embracing of task-shifting'. - Judge Elmarie van der Schyff
While PIMART has been delayed for two years by the IPA Foundation's legal challenge, Judge van der Schyff's ruling now clears the way for the SAPC to proceed with its implementation.
Steve Letsike, Chair of the SAPC's Health Committee and PIMART Task Team, said in a media conference on Thursday that the IPA Foundation has until 8 September to appeal the High Court's decision. Speaking at the same media conference, Mogologolo Phasha, President of the SAPC, indicated that if the IPA Foundation appeals the ruling, the SAPC will continue to fight to preserve the initiative in higher courts.
Spotlight asked the IPA Foundation whether they plan to appeal the decision, but no response was received by time of publication.
The judgement is great news for #HIV treatment and prevention services in SA. #PIMART. Spotlight is working on an article re the judgement. @SECTION27news @SJDStevenson @LindaGailBekker @OfficialSAPC @WitsRHI_TransHC @SAHIVSoc @JulietHoughton @ygpillay @catherinetom https://t.co/t8JLyUB32j
-- Spotlight (@SpotlightNSP) August 15, 2023
The background
The introduction of PIMART was proposed by the SAPC in 2018 in response to a request from the National Department of Health for the SAPC to develop an intervention to enable pharmacists to help get HIV prevention treatment to more people quicker.
Pharmacists trained and accredited under the PIMART initiative will be able to provide preventative therapy for HIV (both post-exposure and pre-exposure prophylaxis - PEP and PrEP), TB preventive therapy, and first-line antiretroviral treatment for uncomplicated HIV.
According to Phasha, around 900 pharmacists, or 5% of pharmacists on the register have already undertaken specialised, supplementary training to enable them to provide PIMART services. He noted, however, that before trained pharmacists would be able to start providing PIMART services they would need to receive accreditation in the form of a permit granted by the National Department of Health under Section 22(A)15 of the Medicines and Related Substances Act.
The court's response to the IPA Foundation's arguments
In February 2022, the IPA Foundation filed an affidavit with the North Gauteng High Court seeking review and dismissal of the SAPC's decision to implement PIMART and related legislation.
In its affidavit, the IPA Foundation argued that the provision of PIMART services falls within the domain of medical doctors and that pharmacists do not have the required training and competencies to provide these services. The IPA Foundation further argued that the SAPC does not have the legislative mandate to introduce PIMART, that the SAPC's reasons for implementing PIMART were not adequately explained, and that the SAPC's procedures for implementing PIMART were not procedurally fair and did not provide adequate opportunity for interested parties to comment.
Pharmacists trained and accredited under the PIMART initiative will be able to provide preventative therapy for HIV (both post-exposure and pre-exposure prophylaxis - PEP and PrEP), TB preventive therapy, and first-line antiretroviral treatment for uncomplicated HIV.
The IPA Foundation warned of a "slippery slope" resulting from PIMART's introduction, adding "this objection essentially warns of the opening of the floodgates or perhaps an anticipated negative precedent setting occurrence relevant to the provision of medication... without prescription".
In her ruling, Judge van der Schyff noted that while tension between healthcare cadres regarding their scopes of practice is common, the World Health Organization calls for "a collaborative approach to primary healthcare issues and the embracing of task-shifting".
Court dismisses IPAF's application on PIMART matter - https://t.co/jRJhJh64lf#Healthcare #Medical #Pharmaceutical #IPAF #SAPC #PIMART
-- AxessHealth (@AxessHealth) August 16, 2023
She added that "competition, per se, does not limit or curtail the rights of medical practitioners to continue providing the services that they currently provide," further stating that "even if the assumed competition is regarded to affect family practitioner's rights adversely, the alleged adverse effect it holds for medical practitioners has to be considered against the need to expand primary healthcare services aimed at preventing and treating HIV".
Judge van der Schyff dismissed the IPA Foundation's argument that the SAPC is not mandated to introduce PIMART, stating that "the SAPC is empowered to prescribe the scope of practice of the various categories of persons registered in terms of the Pharmacy Act". She added, "The development and implementation of PIMART, does not expand the existing scope of practice of pharmacists that generically provides for PIT [pharmacist-initiated therapy] and PCDT [primary care drug therapy]. It introduced a specialised category of PIT and PCDT focused on preventing and treating HIV."
Judge van der Schyff also rejected the IPA Foundation's arguments that PIMART's introduction was procedurally unfair and the decision for its implementation was not properly explained, arbitrary, or capricious. She says that "through its collaboration with the Southern African HIV Clinicians Society, whose members include numerous medical doctors, the development of PIMART was given great exposure".
"The need to widen access to first-line ART [antiretroviral therapy] and TPT [TB preventative therapy] on a community level is not a figment of SAPC's imagination, but a dire need that is also evinced in other countries," held van der Schyff.
Finally, Judge van der Schyff rejected the argument that pharmacists are not adequately trained to provide PIMART services, stating, "The PIMART training course was developed to ensure that pharmacists who successfully completed the training would be 'suitably qualified to safely and effectively assist in providing ART'." She adds that the PIMART training course was "developed by suitably qualified experts in the field, which experts include medical practitioners".
The ruling was welcomed by the SAPC and several HIV groups.
"The superior court yesterday (Wednesday) confirmed what has been our long-held view that PIMART is a necessary and competently designed intervention programme to support South Africa's efforts in providing access to patients diagnosed with HIV and AIDS," said Phasha. "The programme may also arrest and lower the ballooning HIV budget, which is nearly half the national health budget, by reducing the rate of new infections."
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We also have the issue of key populations that are not comfortable to go in public health facilities to access medication... so if a pharmacist is able to issue and prescribe ARVs and TB medication it will mean that we will be able to cover a lot of people. - Sibongile Tshabalala, TAC
Nelson Dlamini, Head of Communications at the South African National AIDS Council (SANAC), told Spotlight that SANAC welcomes the court ruling.
"The magnitude of South Africa's HIV burden requires innovative ways of accessing HIV treatment, care, and support. PIMART is one such approach that will improve access to antiretroviral therapy for people living with HIV and those requiring PEP & PrEP," said Dlamini.
Sibongile Tshabalala, Chairperson of the Treatment Action Campaign (TAC), said the organisation also welcomes the ruling. "The challenges that we are facing in the country include one of people queuing for a long time in facilities... and also the attitude of nurses in facilities which chases away so many people from facilities. We also have the issue of key populations that are not comfortable to go in public health facilities to access medication... so if a pharmacist is able to issue and prescribe ARVs and TB medication it will mean that we will be able to cover a lot of people."
*NOTE: A representative of the TAC is quoted in this article. Spotlight is published by SECTION27 and the TAC, but is editorially independent - an independence that the editors guard jealously. Spotlight is a member of the South African Press Council.
