Case Law[2025] ZASCA 148South Africa
IPA Foundation (NPC) v South African Pharmacy Council (1024/2023) [2025] ZASCA 148; [2026] 1 All SA 41 (SCA) (9 October 2025)
Supreme Court of Appeal of South Africa
9 October 2025
Headnotes
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.
Judgment
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## IPA Foundation (NPC) v South African Pharmacy Council (1024/2023) [2025] ZASCA 148; [2026] 1 All SA 41 (SCA) (9 October 2025)
IPA Foundation (NPC) v South African Pharmacy Council (1024/2023) [2025] ZASCA 148; [2026] 1 All SA 41 (SCA) (9 October 2025)
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sino date 9 October 2025
FLYNOTES:
ADMINISTRATIVE
–
Pharmacy
council –
Scope
of practice
–
Implementation
of pharmacist-initiated management of antiretroviral therapy –
Procedural fairness and rationality –
Council fulfilled its
statutory obligations and provided sufficient notice and
opportunity for public comment – Decision
rationally
connected to objectives in addressing high rate of HIV infections
and improving access to treatment – Scope
limited to
accredited pharmacists – Did not encroach on domain of
medical practitioners – Appeal dismissed.
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, NICHOLLS, HUGHES and UNTERHALTER 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.
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 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
accredited 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 specifically 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 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 these
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 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 ailments 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.
[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.
[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 PIMART 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.’
[17]
On 8 September 2021,
following the publication of Board Notice 101, which introduced the
implementation of PIMART, the IPA submitted
its 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.
[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
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]
[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 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
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 determined 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 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
the 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 signals
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]
[36]
The
Constitutional Court has held that fairness must be determined in
light of the specific circumstances of a particular case.
[17]
As
mentioned, 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 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 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 practitioners. 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 no further legal requirement.
I therefore conclude that the SAPC adhered
to procedural fairness
requirement.
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.’
[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 follows. 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 the
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 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).
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 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
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 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 present
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]
[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
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.
[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).
[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] ZASCA 78
;
[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.
[4]
Joseph
and Others v City of Johannesburg and Others
[2009]
ZACC 30
;
2010 (3) BCLR 212
(CC);
2010 (4) 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.
[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
(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.
[15]
C
Hoexter and G Penfold
Administrative
Law in South Africa
3
rd
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.’
[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 102;
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.
[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.
[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.
[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).
[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’.
[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-
(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.’
[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.
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