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[2005] ZACC 3
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Affordable Medicines Trust and Others v Minister of Health and Another (CCT27/04) [2005] ZACC 3; 2006 (3) SA 247 (CC); 2005 (6) BCLR 529 (CC) (11 March 2005)
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CONSTITUTIONAL
COURT OF SOUTH AFRICA
Case
CCT 27/04
THE
AFFORDABLE MEDICINES
TRUST
First Applicant
THE
NATIONAL CONVENTION ON DISPENSING
Second Applicant
DR
MPHATA NORMAN
MABASA
Third Applicant
versus
THE
MINISTER OF HEALTH OF THE REPUBLIC OF
SOUTH
AFRICA
First Respondent
THE
DIRECTOR-GENERAL OF
HEALTH
Second Respondent
Heard
on :
11 November 2004
Decided
on : 11
March 2005
JUDGMENT
NGCOBO
J:
Introduction
[1]
This is an application for leave to appeal directly to this
Court
from the judgment and order of the Pretoria High Court dismissing a
constitutional challenge to certain aspects of a licensing
scheme
introduced by the government. In terms of this scheme, health
care providers, such as medical practitioners and dentists,
may not
dispense medicines unless they have been issued with a licence to
dispense medicines by the Director-General of the Department
of
Health (Director-General). The scheme also regulates the
premises from which medicines are dispensed. The challenge
was
directed at the powers of the Director-General to prescribe
conditions upon which licences may be issued, the linking of a
licence to dispense medicines to particular premises and the factors
to which the Director-General is required to have regard when
considering an application for a licence.
Background
[2]
The
constitutional challenge was brought by the Affordable Medicines
Trust, the National Convention on Dispensing and Dr Mabasa,
who are
first, second and third applicants, respectively. The first
applicant has, as one of its objects, the promotion of
the “rights”
of medical practitioners “to dispense medicines to the general
public”. The second applicant
is a co-ordinating body
which was established “to act in the interest, and co-ordinate
the activities, of its members.”
[1]
The third applicant is a medical practitioner who was authorised to
dispense medicines under the now repealed section 52
of the Health
Professions Act.
[2]
The
applicants allege that they act in their own interest, in the
interest of, among other persons, medical practitioners
“who at
present have a right and legitimate expectation to be able to
dispense medicines (without obtaining a licence) and
to continue to
do so”, and in the public interest. They allege that they
have the right to institute proceedings under
section 38 of the
Constitution.
[3]
[3]
The first and second respondents are the Minister of Health
and the
Director-General respectively (the respondents), who opposed the
application. The other respondents are the Speaker
of
Parliament, the President, the Health Professions Council of South
Africa, the South African Pharmacy Council, the Medicines
Control
Council of South Africa, the Allied Health Professions Council of
South Africa and the South African Nursing Council.
They are
the third to the ninth respondents respectively, who each has an
identifiable interest in the order sought by the applicants.
No
relief was sought against these respondents and they did not oppose
the relief sought by the applicants.
[4]
In the High
Court the applicants sought an order declaring invalid:
[4]
(a)
Sub-section
22C(1)(a) of the
Medicines and Related Substances Act, 101 of 1965
as
amended (the Medicines Act), to the extent that it permits the
Director-General to issue licences “on the prescribed
conditions”
[5]
; and
(b)
Sub-regulations
18(3)(b), (f), (g), (h) and (i); 18(4); 18(5); 18(6); and regulation
20 of the Regulations made under the Medicines
Act and published in
Government Gazette 24727 under Government Notice R510 of 10 April
2003 (the Regulations).
[6]
Amendment
of regulation 18
[5]
Regulation
18 has, however, been amended. The Regulations came into
operation on 2 May 2003. On 16 October 2003, regulation
18 was
amended by Government Notice R1506 published in Government Gazette No
25593 by: (a) deleting paragraph (c) of sub-regulation
(3);
[7]
and (b) inserting new sub-regulation (4).
[8]
In its preamble, however, Government Notice R1506 provided that the
existing sub-regulation (4) becomes sub-regulation (5),
and said
nothing about the remaining sub-regulations that were affected by the
amendment. Thus on 31 October 2003, by Government
Notice R1565
published in Government Gazette 25622, a correction notice was issued
to correct Government Notice R1506. The
effect of the
correction was to amend regulation 18 by providing that
sub-regulations (4), (5), (6), (7) and (8) became sub-regulations
(5), (6), (7), (8) and (9) respectively. The two notices, read
together, therefore provide in effect that sub-regulations
(4), (5),
(6), (7) and (8) now become sub-regulations (5), (6), (7), (8) and
(9) respectively.
[6]
Now it is plain from these Government Notices that the substance
of
the regulations has not been amended. All that has changed are
the numbers of the sub-regulations. Regulations (4),
(5), (6)
and (7), which concern us in these proceedings, are now
sub-regulations (5), (6), (7) and (8) respectively. Their
substance remains the same. These amendments, which had already
come into operation when the present proceedings were instituted
in
the High Court, were neither drawn to our attention nor that of the
High Court. The relief sought by the applicants must
be amended
to reflect the correct sub-regulation numbers.
[7]
The present
situation is different from that in the
Satchwell
case.
[9]
In that case,
this Court was concerned with confirmatory proceedings and a major
difference between the replaced statutory
provisions and regulations
and the old ones. In the light of this, this Court held that it
could not consider statutory provisions
that had not been declared
invalid by the High Court, and that the proper course to follow was
to approach this Court by way of
a direct access.
[8]
Here we are not concerned with confirmatory proceedings.
In
addition, there are no changes to the contents of the provisions.
All that has changed are sub-regulation numbers.
This is a
matter which could have been cured by an appropriate amendment of the
Notice of Motion to reflect the correct sub-regulation
numbers.
It is difficult to see on what conceivable basis it could have been
opposed. And I cannot conceive of any
prejudice that would have
been suffered by the respondents if the Notice of Motion were to have
been amended. Even if it
had been opposed, it is the kind of
amendment which would have been granted, had it been sought. It
is a formal amendment.
[9]
The
principles governing the granting or refusal of an amendment have
been set out in a number of cases. There is a useful
collection
of these cases and the governing principles in
Commercial
Union Assurance Co Ltd v Waymark NO
.
[10]
The practical rule that emerges from these cases is that amendments
will always be allowed unless the amendment is
mala
fide
(made in bad faith) or unless the amendment will cause an injustice
to the other side which cannot be cured by an appropriate order
for
costs, or “unless the parties cannot be put back for the
purposes of justice in the same position as they were when the
pleading which it is sought to amend was filed.”
[11]
These principles apply equally to a Notice of Motion. The
question in each case, therefore, is what do the interests
of justice
demand.
[10]
It seems to me therefore that it is in the interests of justice that
the relief sought
by the applicants be amended so as to reflect the
correct sub-regulation numbers. Accordingly, the references to
sub-regulations
18(4), (5) and (6) in the relief sought by the
applicants will now be references to sub-regulations 18(5), (6) and
(7) respectively.
The
substance of the impugned provisions
[11]
The impugned provisions are part of the legislative framework that
brought about
the licensing scheme. Subsection 22C(1)(a) of the
Medicines Act makes provision for the Director-General to issue
licences
to health care providers to compound and dispense medicines
“on the prescribed conditions”. Sub-regulation
18(3)
sets out information that must be contained in an application
for a licence, while sub-regulation 18(5) sets out factors that the
Director-General must have regard to when considering an application
for a licence. Sub-regulation 18(6) requires an applicant
for a
licence to publish the notice of intention to apply for a licence in
a newspaper circulating in the area where the applicant
intends to
conduct a practice. Regulation 20 provides that a licence is
valid for a period of three years and makes provision
for its
renewal.
The
legislative framework
[12]
Prior to
the introduction of the licensing scheme, the authority of the
medical practitioners to dispense or compound medicines
was governed
by section 52 of the Health Professions Act. Under this
statute, all that was required of a medical practitioner
who desired
to compound or dispense medicines as part of his or her practice, was
to inform the Health Professions Council of South
Africa, the fifth
respondent, of his or her intention to compound or dispense
medicines.
[12]
At the
discretion of the fifth respondent, the name of such medical
practitioner would then be entered in the register of
medical
practitioners who were allowed to compound or dispense medicines.
Upon registration, a medical practitioner became
entitled personally
to dispense medicines prescribed by him or her or by any medical
practitioner or dentist with whom he or she
was in partnership or
with whom he or she was “associated as principal or associate
or
locum
tenens
.”
[13]
[13]
With effect
from 2 May 2004, the provisions of section 52 of the Health
Professions Act were repealed and replaced by a new section
52.
[14]
In substance, the new section 52 now requires health care providers,
including medical practitioners and dentists, to compound
or dispense
medicines “only on the authority and subject to the conditions
of a licence granted by the Director-General under
the [Medicines
Act].”
[15]
At
about the same time, the Medicines Act was amended by the insertion
of sections 22C to 22H.
[16]
[14]
As pointed
out earlier, subsection 22C(1)(a)
[17]
of the Medicines Act makes provision for the Director-General to
issue licences to health care providers to compound and dispense
medicines “on the prescribed conditions”. The issue
of a licence is subject, among other requirements, to successful
completion of a supplementary course determined by the South African
Pharmacy Council, the sixth respondent, after consultation
with the
Health Professions Council of South Africa, the fifth respondent and
the South African Nursing Council, the ninth respondent.
[18]
In the event of a refusal of a licence, an applicant is entitled to
be furnished with reasons for such refusal. Section
22C
prohibits any person from compounding or dispensing medicines unless
such a person is authorised under “the
Pharmacy Act, 1974
, is a
veterinarian or is the holder of a licence as contemplated in
subsection (1)(a).”
[19]
Section 22D
makes provision for the renewal of a licence.
[15]
On 10 April
2003, the Minister published the Regulations which were made under
the Medicines Act. Among other things, the
Regulations gave
effect to the licensing provisions of the Medicines Act and the
Health Professions Act. For purposes of
these proceedings only
regulations 18
[20]
and 20
[21]
are relevant.
[16]
The
licensing scheme that is in issue in these proceedings is therefore
put in place by subsections 22C(1)(a) and section 22D of
the
Medicines Act read with section 52 of the Health Professions Act and
read further with regulations 18 to 21 of the Regulations.
However, the constitutional challenge that concerns us in these
proceedings is directed only at subsection 22C(1)(a) of the Medicines
Act,
[22]
and the provisions of
regulations 18(3)(b), (f), (g), (h) and (i); 18(5); 18(6); 18(7)
[23]
and 20.
[24]
[17]
The respondents allege, and it is not disputed, that the licensing
scheme is there
to serve a legitimate purpose.
The
government purpose
[18]
The respondents say that what prompted the licensing scheme are bad
dispensing practices
by medical practitioners. These practices
include allowing lay staff to dispense medicines to patients,
dispensing medicines
that have expired, dispensing unlabelled or
wrongly and inappropriately labelled medicines, storing medicines in
inappropriate
places and conditions, and repacking medicines for
dispensing in inappropriate containers. The respondents allege
that these
dispensing practices pose a serious health risk to
patients in that they increase the risk of unsafe medicines being
dispensed.
[19]
The respondents say that prior to the licensing scheme, the
compounding and the dispensing
of medicines by medical practitioners
and other health practitioners, with the exception of pharmacists,
were either not adequately
regulated or not regulated at all.
There were no standards, norms or guidelines to ensure that
dispensers of medicines adhered
to good dispensing and compounding
practices. The old legislative framework did not prohibit
practices such as pharmaceutical
companies giving incentives to
medical practitioners (referred to in the papers before us as
“bonussing”) nor did they
prohibit medical practitioners
from selling on samples they received for free from pharmaceutical
companies. These practices
created a conflict of interest
between the dispensing medical practitioners and their patients.
[20]
This resulted in inappropriate prescribing and dispensing of
medicines, including
the supply to patients of medicines that were
ineffective due to improper storage conditions, or that had expired,
which could
adversely affect a patient’s health, and the
charging of the public for medicines that had been obtained as free
samples
from suppliers. The respondents say all this conspires
to increase the costs of health care to the public and undermines the
safety, quality and efficacy of the medicines that are dispensed to
patients. They say that bad dispensing practices compromise
and
place in jeopardy the health of patients and that of the public at
large and constitute a denial of access to health care to
the public.
[21]
According to the respondents, the licensing scheme is directed
at addressing
these bad dispensing and compounding practices and
their consequences. The underlying objective behind the scheme
is to increase
access to medicines that are safe for consumption by
the public. This is to be achieved, among other things, by
ensuring
that health care practitioners who dispense and compound
medicines are adequately trained in good dispensing practice and
maintain
high standards in the safe and proper storage, labelling,
handling and keeping of medicines. To this end, the respondents
say that the sale of medicines, their suitability, the standard of
dispensing, the suitability of premises where medicines are
kept and
the conditions under which they are kept, must be properly regulated.
[22]
All this is common cause. The applicants do not dispute the
stated government
purpose. Nor its legitimacy. Instead,
the applicants have sought to challenge the means used by the
government to achieve
its objective to increase access to medicines
that are safe for consumption. They contended that the means
used by the government
to achieve its objective are either not
rationally related to the stated objective or are not authorised by
the empowering provisions
of the Medicines Act. It will be
convenient to deal with these contentions when considering the
constitutional challenges.
[23]
Suffice it to hold at this stage that on the record, the respondents
have demonstrated
the existence of a government purpose sought to be
achieved by the licensing scheme. That purpose is to increase
access to
medicines that are safe for consumption. And the
legitimacy of this purpose cannot be gainsaid. The finding and
the
conclusion of the High Court in this regard cannot be faulted.
The applicants did not contend otherwise in this Court.
The
constitutional challenge
[24]
In this Court, as in the High Court, the applicants challenged, in
the first place,
the inclusion of the phrase “on the prescribed
conditions” in sub-section 22C(1)(a) contending that it is
overbroad
and therefore vague. They contended that it does not
convey to those affected what is relevant to the exercise of that
power
and gives either the Minister or the Director-General wide,
unlimited and un-circumscribed arbitrary legislative powers.
They submitted that this is in breach of the principle of legality.
[25]
In the
second place, the applicants contended that the “coupling”
of a licence to compound and dispense medicines to
specific premises,
which regulation 18 requires, is not authorised by sub-section
22C(1)(a) or section 35 of the Medicines Act.
The Minister,
therefore, exceeded her powers when making regulation 18 and
therefore breached the principle of legality.
In the
alternative, the applicants contended that the requirement of
“coupling” does not fall within the purview of
section 22
of the Constitution, which permits only the practice of a profession
to be regulated by law. In addition, they
contended that
coupling violates other rights in the Bill of Rights.
[25]
[26]
In the third place they attacked sub-regulations 18(5), (6) and (7)
on a number of
grounds but principally on the ground that their
provisions are vague in that they require the Director-General to
make decisions
based on facts that are not objectively
ascertainable. In addition, they contended that the provisions
of sub-regulation
18(3) read with sub-regulation 18(5) create a
framework for refusing a licence where there is a pharmacy in the
vicinity of the
premises from which an applicant for a licence
intends dispensing medicines. This too, infringes the principle
of legality,
they argued.
The
High Court decision
[27]
The High Court found that the licensing scheme was introduced by the
government in
order to achieve its objective to increase access to
medicines that are safe for consumption. This is a legitimate
purpose
to pursue. It held that the Minister did not exceed her
powers when making regulation 18 which linked the licence to compound
and dispense medicines to specific premises. The Minister did
not therefore breach the principle of legality. The High
Court
also found that there is nothing arbitrary or capricious in any of
the impugned provisions of regulation 18.
[28]
It also held that the licensing scheme does no more than regulate the
practice of
dispensing medicines within permissible constitutional
limits. The scheme does not infringe the right of medical
practitioners
to choose to practise as medical practitioners or to
choose to dispense medicines as part of their practice. It does
not
therefore infringe section 22 of the Constitution. Nor does
it infringe any of the other constitutional rights asserted by
the
applicants. It accordingly dismissed the constitutional
challenge and ordered the applicants to pay costs.
[29]
It is against this decision that the applicants are seeking leave to
appeal.
I shall now deal with these constitutional challenges
in turn.
Is
it impermissible for the legislature to leave it to the Minister or
the Director-General to prescribe the conditions upon which
a licence
may be issued?
[30]
Sub-section 22C(1)(a) provides:
“
Subject
to the provisions of this section —
(a)
the Director-General may on application in the prescribed manner and
on payment of the prescribed fee issue to a medical practitioner,
dentist, practitioner, nurse or other person registered under the
Health Professions Act, 1974, a licence to compound and dispense
medicines, on the prescribed conditions.”
[31]
The applicants contended that the phrase “on the prescribed
conditions”
in sub-section 22C(1)(a) is arbitrary, capricious,
overbroad and vague. They submitted that the legislature
should
have spelt out the precise conditions upon which the
Director-General may issue a dispensing licence. Otherwise, the
Director-General
is left with un-circumscribed arbitrary powers, the
applicants argued. In essence this challenge raises the
question of whether
it is permissible for Parliament to leave it to
the Director-General to prescribe the conditions upon which a licence
may be issued.
[32]
The
“prescribed conditions” referred to in sub-section
22C(1)(a) are not set out in the Medicines Act. What the
section in effect does is to leave it to the Director-General to
determine what those prescribed conditions shall be. There
is
nothing in the Constitution which prevents Parliament from delegating
subordinate regulatory authority to other bodies.
In
Executive
Council, Western Cape Legislature, and Others v President of the
Republic of South Africa and Others
[26]
,
Chaskalson P said:
“
The legislative
authority vested in Parliament under s37 of the Constitution is
expressed in wide terms – ‘to make laws
for the Republic
in accordance with this Constitution’. In a modern State
detailed provisions are often required for
the purpose of
implementing and regulating laws and Parliament cannot be expected to
deal with all such matters itself. There
is nothing in the
Constitution which prohibits Parliament from delegating subordinate
regulatory authority to other bodies.
The power to do so is
necessary for effective law-making. It is implicit in the power
to make laws for the country and I
have no doubt that under our
Constitution Parliament can pass legislation delegating such
legislative functions to other bodies.
There is, however, a
difference between delegating authority to make subordinate
legislation within the framework of a statute
under which the
delegation is made, and assigning plenary legislative power to
another body, including, as s16A does, the power
to amend the Act
under which the assignment is made.”
[27]
(footnote omitted)
[33]
Nor is
there anything that prevents Parliament from conferring upon the
Director-General the discretion to determine those conditions.
Discretion has an important role to play in decision making.
And its scope may vary. In
Dawood
,
[28]
this Court held:
“
Discretion plays a
crucial role in any legal system. It permits abstract and
general rules to be applied to specific and particular
circumstances
in a fair manner. The scope of discretionary powers may vary.
At times they will be broad, particularly
where the factors relevant
to a decision are so numerous and varied that it is inappropriate or
impossible for the Legislature
to identify them in advance.
Discretionary powers may also be broadly formulated where the factors
relevant to the exercise
of the discretionary power are indisputably
clear. A further situation may arise where the decision-maker
is possessed of
expertise relevant to the decisions to be made.”
[29]
(footnote omitted)
[34]
However,
the delegation must not be so broad or vague that the authority to
whom the power is delegated is unable to determine the
nature and the
scope of the powers conferred. For this may well lead to the
arbitrary exercise of the delegated power.
Where broad
discretionary powers are conferred, there must be some constraints on
the exercise of such power so that those who
are affected by the
exercise of the broad discretionary powers will know what is relevant
to the exercise of those powers or in
what circumstances they are
entitled to seek relief from an adverse decision.
[30]
These constraints will generally appear from the provisions of the
empowering statute as well as the policies and objectives
of the
empowering statute.
[35]
It is true, as counsel for the applicants submitted, sub-section
22C(1)(a) confers
wide discretion on the Director-General. But
this does not mean that the Director-General has uncontrolled and
unlimited
discretion to impose whatever conditions he or she likes.
The exercise of discretion by the Director-General is subject to
certain constraints, apart from the constitutional constraints.
In the exercise of his or her discretion, the Director-General
must
have regard to all relevant considerations and disregard improper
considerations. The conditions that he or she is permitted
to
impose are those that are rationally related to the purpose for which
his or her discretionary powers were given.
[36]
The
question whether there are any constraints on the exercise of
discretionary powers is essentially a matter of construction of
the
empowering statute. In this regard it is important to remember
that sub-section 22C(1)(a), consistent with our jurisprudence,
ought
to be construed in a manner that is consistent with our Constitution,
including the doctrine of vagueness, if possible.
[31]
And credit ought to be given to the Director-General who has to
administer this provision that he or she will do so in accordance
with the law and the Constitution. Were the Director-General to
issue a licence on conditions in conflict with the powers
conferred
upon him or her, the decision could be set aside.
[37]
The fundamental flaw in the applicants attack on sub-section
22C(1)(a) is that it
does not take sufficient account of these
matters.
[38]
The answer to the attack on sub-section 22C(1)(a) is that counsel for
the applicants
is giving too wide an interpretation on the
sub-section. The power of the Director-General to prescribe
conditions under
sub-section is limited by the context in which these
powers are to be exercised. Thus the power to prescribe
conditions,
must be exercised in the light of, amongst other
considerations, the government purpose to increase access to
medicines that are
safe for consumption, the purpose for which the
discretionary powers are given, and the obligations of medical
practitioners who
have been issued with dispensing licenses.
All this provides sufficient constraint on the exercise of the
discretionary powers
conferred by the sub-section.
[39]
Thus in determining what conditions to prescribe, the
Director-General will be guided
by the provisions of the Medicines
Act read in the light of its objectives and policies. In
particular, the Director-General
will be guided by the government
purpose behind the licensing scheme, namely, the need to increase the
access to medicines that
are safe for consumption. In addition,
the Director-General will be guided by the relevant provisions of the
Regulations
such as those that set out the obligations of the persons
who have been issued with licences.
[40]
Sub-regulation
18(8) is particularly relevant in this context.
[32]
It sets out the obligations of persons who have been issued with
licences. It indicates the kind of conditions that the
Director-General may impose. These relate to the keeping of the
records relating to medicines compounded and dispensed; ensuring
that
the dispensary and any premises where medicines are kept, are
suitable for dispensing or compounding and that dispensing is
in
accordance with good dispensing practice; keeping medicines under the
required conditions and the keeping of the premises where
medicines
are compounded and dispensed. This statutory framework provides
sufficient guidance to the Director-General as
to the kind of
conditions that may be prescribed under the powers conferred by
sub-section 22C(1)(a) of the Medicines Act.
It follows
therefore that the challenge directed at the phrase “on the
prescribed conditions” must fail.
Did
the Minister exceed her powers in requiring a licence to be linked to
premises?
[41]
At the outset it must be pointed out that the licencing scheme in
itself is not under
challenge. The primary challenge is
directed at what was described as “the coupling of the licence
to dispense medicines
to specific premises.” As counsel
for the applicants put it in the course of oral argument, “we
are here because
of coupling”. By coupling, the
applicants refer to the requirement that a dispensing licence be
issued in respect of
specific or particular premises which
requirement, they contended, is introduced by the provisions of
regulation 18. They
contended, in the first place, that neither
sub-section 22C(1)(a) nor section 35 of the Medicines Act requires
that a licence be
linked to particular premises and that therefore
the Minister exceeded her powers in developing a policy of linking
licences to
dispense medicines to particular premises in the
regulations and thus breached the principle of legality.
[42]
The fundamental flaw in the applicants’ attack on the linking
of a licence
to particular premises is the assumption that a medical
practitioner who practises as a
locum
tenens
will not be able to get a licence to dispense because such
medical practitioners do not have premises of their own from which
they
practise. A
locum tenens
will be denied a licence,
the applicants argued, because regulation 18 precludes the
Director-General from issuing a licence to
a health-care provider who
has no particular premises from which to dispense medicines. In
particular, they relied upon sub-regulation
18(3)(b) which requires
an applicant for a licence to provide information relating to “the
exact location of the premises
where compounding and/or dispensing
will be carried out”; sub-regulation 18(8) which deals with the
keeping of premises from
which medicines are dispensed; and the fact
that licences issued thus far specify the premises from which
medicines may be dispensed.
Confronted by a licence that was
issued to Dr Ahmed who practises as a
locum tenens
, the
applicants were constrained to submit that such a licence had been
unlawfully issued by the Director-General.
[43]
The
applicants made much of the fact that unlike the previous legislative
scheme, neither the Medicines Act nor the regulations
make reference
to a
locum
tenens.
[33]
That is true. The absence of a reference to
locum
tenens
in the new scheme does not mean that a
locum
tenens
is excluded from obtaining a licence to dispense medicines as the
applicants contended. This is a matter of construction.
[44]
Regulation
18 does not expressly require the licence to dispense medicines to be
linked to specific premises. However, the
regulation
contemplates that health-care providers who wish to dispense
medicines will do so from some premises. Such premises
will
either be the premises that a medical practitioner occupies and
practises from or premises of another medical practitioner
with whom
the medical practitioner is associated as an assistant or
locum
tenens
.
It is these premises that must be “suitable for dispensing or
compounding and dispensing in accordance with good pharmacy
practice”.
[34]
And
it is in this context that the requirement to furnish “the
exact location of the premises where compounding and/or dispensing
will be carried out”,
[35]
must be
understood.
[45]
Thus a medical practitioner, who wishes to dispense medicines as part
of his or her
practice, may be issued with a licence reflecting the
premises from which he or she conducts his or her practice as the
premises
from which medicines will be dispensed. In the case of
a medical practitioner who practises as an assistant, the licence
will reflect the premises of the principal, these being the premises
from which such medical practitioner will dispense medicines.
Similarly, a
locum tenens
will dispense medicines from the
premises of the principal who has been issued with a licence to
dispense medicines. But as
a
locum tenens
may work for
different principals who may not be known in advance, the licence may
be issued subject to the condition that he or
she may only dispense
medicines from premises of principals who have been issued with
licences to dispense medicines.
[46]
I conclude
therefore that there is nothing in regulation 18 which prevents the
Director-General from issuing a licence to a
locum
tenens
subject to the condition that he or she may only dispense medicines
from premises in respect of which a dispensing licence has
been
issued. Sub-section 22C(1)(a) contemplates that a licence will
be issued subject to “prescribed conditions”.
So
does sub-section 52(1)(a) of the Health Professions Act.
[36]
A
locum
tenens
may only dispense medicines from the premises of those medical
practitioners who have been issued with licences to dispense
medicines
from their premises. It is in this context that the
locum
tenens
licence that was issued to Dr Ahmed must be understood.
[47]
Regulation 18 can only be said to be linking a licence to particular
premises in
the sense that: (a) it requires medicines to be dispensed
from some premises, and (b) these premises must be suitable for
dispensing
or compounding medicines in accordance with good pharmacy
practice as required by sub-regulation 18(8). Regulation 18
does
not preclude the Director-General from issuing a licence to a
locum tenens
. It now remains to consider whether in
making regulations that require that a licence to dispense medicine
be linked to the
premises from which dispensing takes place the
Minister exceeded the powers conferred by the Medicines Act.
Is
the linking of a licence to specific premises authorised by the
Medicines Act?
[48]
Our
constitutional democracy is founded on, among other values, the
“[s]upremacy of the constitution and the rule of law.”
[37]
The very next provision of the Constitution declares that the
“Constitution is the supreme law of the Republic; law
or
conduct inconsistent with it is invalid”.
[38]
And to give effect to the supremacy of the Constitution, courts “must
declare that any law or conduct that is inconsistent
with the
Constitution is invalid to the extent of its inconsistency”.
[39]
This commitment to the supremacy of the Constitution and the rule of
law means that the exercise of all public power is now
subject to
constitutional control.
[49]
The
exercise of public power must therefore comply with the Constitution,
which is the supreme law, and the doctrine of legality,
which is part
of that law.
[40]
The
doctrine of legality, which is an incident of the rule of law, is one
of the constitutional controls through which the
exercise of public
power is regulated by the Constitution.
[41]
It entails that both the legislature and the executive “are
constrained by the principle that they may exercise no
power and
perform no function beyond that conferred upon them by law.”
[42]
In this sense the Constitution entrenches the principle of legality
and provides the foundation for the control of public
power.
[43]
[50]
In
exercising the power to make regulations, the Minister had to comply
with the Constitution, which is the supreme law, and the
empowering
provisions of the Medicines Act. If, in making regulations the
Minister exceeds the powers conferred by the empowering
provisions of
the Medicines Act, the Minister acts
ultra
vires
(beyond the powers) and in breach of the doctrine of legality.
The finding that the Minister acted
ultra
vires
is in effect a finding that the Minister acted in a manner that is
inconsistent with the Constitution and his or her conduct is
invalid.
[44]
What would
have been
ultra
vires
under common law by reason of a functionary exceeding his or her
powers, is now invalid under the Constitution as an infringement
of
the principle of legality.
[45]
The question, therefore, is whether the Minister acted
ultra
vires
in making regulations that link a licence to compound and dispense
medicines to specific premises. The answer to this question
must be sought in the empowering provisions.
[51]
The contention by the applicants that regulation 18 was made under
sub-section 22C(1)(a)
because it refers to that sub-section was
rightly rejected by the High Court. Regulation 18 does no more
than remind its
reader that a licence to dispense medicines is issued
by the Director-General as provided for in sub-section 22C(1)(a).
It
does not purport to invoke sub-section 22C(1)(a) as the source of
the authority to make it. The source of authority to make
regulations is section 35 of the Medicines Act.
[52]
Section 35
empowers the Minister to make regulations. It confers wide
powers on the Minister to make regulations relating
to the safety,
quality and efficacy of medicines. These powers include the
power to: regulate, control, restrict or prohibit
the sale or use of
any medicine;
[46]
make
regulations with regard to any matter to ensure the safety, quality
and efficacy of medicines;
[47]
regulate conditions under which medicines may be sold;
[48]
make regulations with regard to any matter which shall or may be
prescribed under the Medicines Act;
[49]
and generally for the efficient carrying out of the objects and
purposes of the Medicines Act.
[50]
These powers are wide enough to include the power to make regulations
relating to the storage and keeping of medicines.
The
applicants conceded that the Minister may make regulations pertaining
to the storage and keeping of medicines, and that she
may regulate
the premises from which medicines are dispensed.
[53]
In
addition, sub-section 22C(1)(a) contemplates that a licence will be
issued subject to “prescribed conditions”.
So does
sub-section 52(1)(a) of the Health Professions Act.
[51]
These provisions confer on the Director-General the power to
prescribe conditions to which the licence to dispense medicines
will
be subject. Such conditions, however, must be in the
furtherance of the policies and objectives of the Medicines Act,
namely, to increase access to medicines that are safe for
consumption. If the public is to have access to medicines that
are safe, the activity of dispensing medicines cannot reasonably be
delinked from the premises from which such dispensing takes
place.
[54]
The control and regulation of persons who may dispense medicines and
the premises
from which medicines may be dispensed are essential to
the promotion of access to medicines that are safe for consumption by
the
public. Such control and regulation ensures that persons
who dispense medicines are properly trained in good dispensing
practice
and that the premises from which dispensing takes place are
suitable for storage and thus the dispensing of safe medicines.
Dispensing from specific premises that are regulated facilitates the
inspection of the premises in order to ensure that good dispensing
practice is observed. The storage of medicines and the
appropriateness of the premises from which medicines are dispensed
are aspects of dispensing medicines.
[55]
For all these reasons, the contention that the Minister exceeded her
powers in making
regulations that link a licence to dispense
medicines to particular premises, cannot be sustained. The
finding of the High
Court in this regard must, therefore, be upheld.
But the applicants had another string to their bow. They
contended
that if the scheme of the Medicines Act authorises the
linking of the issuing of a licence to dispense medicines to specific
premises,
it falls outside the purview of regulation permitted by
section 22 of the Constitution.
Does
the linking of a licence to dispense medicine to particular premises
infringe section 22 of the Constitution?
[56]
The
applicants contended in effect that the linking of a licence to
dispense medicines to particular premises falls outside
the purview
of section 22 of the Constitution.
[52]
This is so, they argued, because it limits the choice of a profession
and does not limit the practice of a profession as
permitted by
section 22. It will be convenient to determine first the scope
of the right comprehended in section 22, and
thereafter to consider
whether the regulation in issue regulates the choice or the practice
of a profession.
(a)
The
scope of section 22
[57]
Section 22 of the Constitution provides :
“
Every
citizen has the right to choose their trade, occupation or profession
freely. The practice of a trade, occupation or
profession may
be regulated by law.”
[58]
In broad terms this section has to be understood as both repudiating
past exclusionary
practices and affirming the entitlements
appropriate for our new open and democratic society. Thus in
the light of our history
of job reservation, restrictions on
employment imposed by the pass laws and the exclusion of women from
many occupations, to mention
just a few of the arbitrary laws and
practices used to maintain privilege, it is understandable why this
aspect of economic activity
was singled out for constitutional
protection. Yet the significance of the section goes further.
[59]
What
is at stake is more than one’s right to earn a living,
important though that is. Freedom to choose a vocation
is
intrinsic to the nature of a society based on human dignity as
contemplated by the Constitution. One’s work is part
of
one’s identity and is constitutive of one’s dignity.
Every individual has a right to take up any activity
which he or she
believes himself or herself prepared to undertake as a profession and
to make that activity the very basis of his
or her life. And
there is a relationship between work and the human personality as a
whole. “It is a relationship
that shapes and completes
the individual over a lifetime of devoted activity; it is the
foundation of a person’s existence”.
[53]
[60]
Though economic necessity or cultural barriers may unfortunately
limit the capacity
of individuals to exercise such choice, legal
impediments are not to be countenanced unless clearly justified in
terms of the broad
public interest. Limitations on the right to
freely choose a profession are not to be lightly tolerated. But
we live
in a modern and industrial world of human interdependence and
mutual responsibility. Indeed we are caught in an inescapable
network of mutuality. Provided it is in the public interest and
not arbitrary or capricious, regulation of vocational activity
for
the protection both of the persons involved in it and of the
community at large affected by it, is to be both expected and
welcomed. These considerations are reflected in the text of
section 22.
[61]
It is against this background that section 22 must be understood and
construed.
[62]
The first sentence of section 22 guarantees the right to choose a
profession, while
the second provides for the regulation of the
practice of a profession. It is true that this provision does
not expressly
guarantee the right to practise the chosen profession.
However, the second sentence gives a clue as to the content of the
right comprehended in the provision. It indicates that the
right guaranteed in the provision also embraces the right to practise
the chosen profession. This must be so because the choice of a
profession is implicit in the practice of a profession, and
the
practice of the profession is a manifestation of the choice of a
profession. It is inconceivable that the framers of
the
Constitution would guarantee the right to choose a profession but not
the right to practise the chosen profession.
[63]
The two sentences in section 22 must therefore be read together as
defining the content
of the right guaranteed by the provision.
There are two components to this right: it is the right to choose a
profession
and the right to practise the chosen profession.
This is implicit, if not explicit from the text of section 22.
It
refers to the right to choose a trade, occupation or profession in
the first sentence and the regulation of the practice of a trade,
occupation or profession in the second sentence. It
contemplates that the chosen profession would be practised and
protects
both the right to choose a profession and the right to
practise the chosen profession.
[64]
This construction of section 22 accords with the approach of the
German Federal Constitutional
Court (the German Court) to article
12(1) of the Basic Law, which is almost identical to section 22.
Article 12(1) provides:
“
All Germans shall
have the right freely to choose their trade, occupation, or
profession, their place of work, and their place of
training.
The practice of trades, occupations, and professions may be regulated
by or pursuant to a law.”
[54]
[65]
The
leading decision on article 12(1) is the
Pharmacy
case of
1958.
[55]
In that case
the court held that both concepts of
choice
and
practice
“represent a complex unity and, although viewed from different
angles, are incorporated into the notion of ‘vocation
activity’.”
[56]
Noting, among other things, the difficulty of drawing a clear line
between choice and practice, and the fact that article
74(19) of the
Basic Law authorise the legislature to regulate admission to certain
professions, the court found that choice and
practice of a profession
constituted poles of a continuum.
[57]
It held that article 12(1) guarantees the unitary right of freedom of
occupational activity that embraces both the choice
and the practice
of a profession.
[58]
[66]
Construed purposively, therefore, section 22 embraces both the right
to choose a
profession and the right to practise the chosen
profession.
[67]
The applicants contended that the regulation in issue here goes to
the right to choose
a profession. They contended that
dispensing medicines is a core function of medical practitioners.
In this regard,
we were referred to the history of the medical
profession dating as far back as 1823. This history, it was
submitted, shows
that dispensing medicine was an inherent part of the
practice of medical practitioners. The regulation at issue
here, it
was submitted, therefore goes to the choice of the medical
profession. It goes beyond what is permissible under section
22.
It will be convenient therefore to deal first with the
applicants’ contention that the regulation in issue here goes
to the
choice of a profession.
Does
the linking limit the choice of a profession?
[68]
The question is whether the requirement to dispense medicines from
licensed premises
limits the right to choose a profession.
Where the law that regulates the practise of a profession, viewed
objectively, would
affect negatively the choice of a profession, that
regulation limits the right to choose a profession. To that
extent such
regulation does not fall within the permissible
regulation of the practice of a profession permitted by section 22.
It must
therefore be evaluated under section 36(1) of the
Constitution. However, if the law that regulates the practice
of a profession,
when viewed objectively, would not affect negatively
the choice of a profession, such regulation must be evaluated under
section
22. In each case, therefore, the question is whether
the law which purports to regulate the practice of a profession,
viewed
objectively, would impact negatively on the choice of a
profession. In the view I take of the regulation involved in
this
case, it is not necessary to determine the precise degree of
impact on choice that will constitute a limitation of section 22.
[69]
The requirement to dispense medicines from licensed premises affects
the conduct
of the medical profession. It regulates the conduct
of medical practitioners who are qualified to practise as such, in
particular,
those who wish to compound and dispense medicines as part
of their practices. It requires such medical practitioners to
undergo
supplementary training in, among other things, good
dispensing practice, and once they have undergone such training, to
dispense
medicines in accordance with such good dispensing practices,
including keeping suitable premises from which dispensing will take
place. Clearly it does not purport to regulate entry into the
medical profession, nor affect continuing choice of practitioners
as
to whether to remain medical practitioners or not. It merely
regulates the specific circumstances in which medical practitioners
may, if they choose, continue to compound and dispense medicines.
[70]
The regulation at issue here deals with how those health care
providers who wish
to compound and dispense medicines as part of
their practices may do so. It assumes that a person is
qualified to practise
as a medical practitioner. It requires
those medical practitioners who would like to compound or dispense
medicines as part
of their practices, to do so from premises that are
suitable for that purpose in accordance with good dispensing
practices, a requirement
that is admittedly essential to ensuring the
safety of medication that is consumed by the public. Those
medical practitioners
who do not wish to dispense medicines, as some
of them choose not to, need not comply with this requirement.
[71]
There is no suggestion that this requirement, viewed objectively,
would have the
effect of influencing negatively a person’s
decision whether to become a medical practitioner. Indeed it is
difficult
to fathom how a person who has chosen to pursue a medical
profession and is prepared to undergo some six years of academic
training
to that end, can ever be deterred from that ambition by the
requirement that, if, upon qualification, he or she wishes to
dispense
medicine as part of his or her practice, he or she would be
required, among other things, to dispense medicines from premises
that
comply with good dispensing practice.
[72]
In my view, the regulation at issue here unquestionably regulates the
practice of
the medical profession. Moreover, it regulates
practice in a manner that, viewed objectively, will not affect the
choice
of a profession in any negative manner. The submission
that it goes to choice of the medical profession must therefore be
rejected. The question that falls to be determined therefore is
whether the regulation at issue meets the standard for permissible
regulation of the practice of a profession under section 22.
But first, what is that standard?
The
standard for determining permissible regulation under section 22
[73]
Unlike
its predecessor, section 22 contains no express limitation on the
power to regulate the practice of a profession.
[59]
It accords Parliament the general power to enact legislation that
regulates the practice of a profession. Under our
Constitution,
the legislature is vested with legislative authority. Within
its province, the legislature has wide powers
indeed. However,
these powers are subject to constitutional control. The same is
true of the exercise of all public
power.
[74]
The
exercise of all legislative power is subject to at least two
constitutional constraints. The first is that there
must be a
rational connection between the legislation and the achievement of a
legitimate government purpose.
[60]
As this Court has observed, the idea of the constitutional state
presupposes a system whose operation can be rationally tested.
[61]
Thus when Parliament enacts legislation that differentiates between
groups and individuals, it is required to act in a rational
manner.
[62]
In
New
National Party of South Africa v Government of the Republic of South
Africa and Others
,
[63]
the Court held that the rational connection test is the standard for
reviewing legislation holding that:
“
The first of the
constitutional constraints placed upon Parliament is that there must
be a rational relationship between the scheme
which it adopts and the
achievement of a legitimate governmental purpose. Parliament
cannot act capriciously or arbitrarily.
The absence of such a
rational connection will result in the measure being
unconstitutional.”
[64]
[75]
The
same is true of the exercise of public power by members of the
executive and other functionaries. The Constitution
places
“significant constraints upon the exercise of public power
through the bill of rights and the founding principle enshrining
the
rule of law.”
[65]
The exercise of such power must be rationally related to the purpose
for which the power was given.
[66]
As this Court held in the
Pharmaceutical
[67]
case:
“
[85]
It is a requirement of the rule of law that the exercise of public
power by the Executive and other functionaries
should not be
arbitrary. Decisions must be rationally related to the purpose
for which the power was given, otherwise they
are in effect arbitrary
and inconsistent with this requirement. It follows that in
order to pass constitutional scrutiny
the exercise of public power by
the Executive and other functionaries must, at least, comply with
this requirement. If it
does not, it falls short of the
standards demanded by our Constitution for such action.
[86]
The question whether a decision is rationally related to the purpose
for which the power was
given calls for an objective enquiry.
Otherwise a decision that, viewed objectively, is in fact irrational,
might pass muster
simply because the person who took it mistakenly
and in good faith believed it to be rational. Such a conclusion
would place
form above substance and undermine an important
constitutional principle.”
[68]
(footnote omitted)
[76]
The other
constitutional constraint is the Bill of Rights. Legislation
must not infringe any of the fundamental rights
enshrined in the Bill
of Rights.
[69]
The
rights in the Bill of Rights may, however, be limited by a law of
general application. But such a limitation is
limited by the
limitations contained in section 36(1) of the Constitution or
“elsewhere in the Bill [of Rights].”
[70]
A limitation that does not comply with such limitations, infringes
the right in question.
[77]
These two constitutional constraints define the scope of the
regulation of the practice
of a profession which is permitted under
section 22. Legislation that regulates practice will pass
constitutional muster
if (a) it is rationally related to the
achievement of a legitimate government purpose; and (b) it does not
infringe any of the
rights in the Bill of Rights. What the
Constitution therefore requires is that the power to regulate the
practice of a profession
be exercised in an objectively rational
manner. As long as the regulation of the practice, viewed
objectively, is rationally
related to the legitimate government
purpose, a court cannot interfere simply because it disagrees with it
or considers the legislation
to be inappropriate.
[78]
In the
Pharmaceutical
case, this Court, in the context of the
exercise of all public power by members of the executive and other
functionaries, explained
the scope of the rationality standard as
follows:
“
Rationality in
this sense is a minimum threshold requirement applicable to the
exercise of all public power by members of the Executive
and other
functionaries. Action that fails to pass this threshold is
inconsistent with the requirements of our Constitution
and therefore
unlawful. The setting of this standard does not mean that the
Courts can or should substitute their opinions
as to what is
appropriate for the opinions of those in whom the power has been
vested. As long as the purpose sought to be
achieved by the
exercise of public power is within the authority of the functionary,
and as long as the functionary’s decision,
viewed objectively,
is rational, a Court cannot interfere with the decision simply
because it disagrees with it or considers that
the power was
exercised inappropriately. A decision that is objectively
irrational is likely to be made only rarely but,
if this does occur,
a Court has the power to intervene and set aside the irrational
decision.”
[71]
(footnote
omitted)
[79]
These comments apply equally to legislation.
[80]
The standard for determining whether the regulation of the practice
of a profession
falls within the purview of section 22 can therefore
be formulated as follows: if the regulation of the practice of a
profession
is rationally related to a legitimate government purpose
and does not infringe any of the rights in the Bill of Rights, it
will
fall within the purview of section 22. Where the
regulation of a practice, viewed objectively, is likely to impact
negatively
on the choice of a profession, such regulation will limit
the right freely to choose a profession guaranteed by section 22, and
must therefore meet the test under section 36(1). Similarly,
where the regulation of practice though falling within the purview
of
section 22, but limits any of the rights in the Bill of Rights, it
must meet the section 36(1) standard.
[81]
In
Van
Rensburg v South African Post Office Ltd
,
[72]
a case which concerned section 22, the full bench of the Eastern Cape
High Court described the restriction on the right to practise
a trade
imposed by the provisions of the Post Office Act 44 of 1958 as a
“restriction [that] falls within the reasonable
regulation of
the conduct of the postal service” and therefore which falls
within the purview of section 22.
[73]
It said:
“
By giving the Post
Office an exclusive right to practise the trade, occupation or
profession of conducting the postal service in
South Africa, the Post
Office Act restricts the appellant’s right
to
practise
this trade, occupation or profession. But it does not take away
his right to choose it . . . this restriction falls within
the
reasonable regulation of the conduct of the postal service.”
[74]
It
is not clear from this
dictum
whether the court intended to formulate any test by referring to
“reasonable regulation”. Elsewhere, the court
seems
to suggest that restrictions on the practice of a profession must be
“necessary or desirable”.
[75]
If the court intended to adopt reasonableness as a standard for
reviewing legislation that regulates the practice of a profession,
I
am, with respect, unable to agree.
[82]
In
New National Party
, the Court explained why the rational
connection was more appropriate in reviewing legislation than
reasonableness, and said:
“
Decisions as to
the reasonableness of statutory provisions are ordinarily matters
within the exclusive competence of Parliament.
This is
fundamental to the doctrine of separation of powers and to the role
of Courts in a democratic society. Courts do
not review
provisions of Acts of Parliament on the grounds that they are
unreasonable. They will do so only if they are satisfied
that
the legislation is not rationally connected to a legitimate
government purpose. In such circumstances, review is competent
because the legislation is arbitrary . . . If the legislation
defining the scheme is rational, the Act of Parliament cannot be
challenged on the grounds of ‘unreasonableness’.
Reasonableness will only become relevant if it is established
that
the scheme, though rational, has the effect of infringing the right
of citizens to vote. The question would then arise
whether the
limitation is justifiable under the provisions of s 36 of the
Constitution and it is only as part of this s 36 enquiry
that
reasonableness becomes relevant. It follows that it is only at
that stage of enquiry that the question of reasonableness
has to be
considered.”
[76]
(footnote omitted)
[83]
In
S
v Lawrence; S v Negal; S v Solberg
,
[77]
this Court had to consider, among other issues, the test for
determining what constraints upon economic activity and the earning
of a livelihood fall outside the purview of section 26(2) of the
Interim Constitution, the predecessor of section 22.
[78]
The Court adopted the rational basis test, holding that “s
26(2) should be construed as requiring only that there be
a rational
connection between the legislation and the legislative purpose
sanctioned by the section.”
[79]
In adopting this test the Court found that the language of section
26(2) neither required measures to be reasonable nor proportional,
both of which were the requirements of section 33 of the Interim
Constitution, the predecessor of section 36(1) of the Constitution.
It added, “[t]he proportionality analysis which is required to
give effect to the criterion of ‘reasonableness’
in s 33
forms no part of a s 26 analysis.”
[80]
[84]
It is
true, the wording of section 26(2) is different to that of section
22. The effect of section 26(2) was that a
measure “‘designed’
to promote the protection or improvement of any of the matters
referred to in the subsection,
and is a measure justifiable in an
open and democratic society based on freedom and equality”
[81]
did not infringe sub-section 26(1). It is also true that the
Court assumed that the correct approach to sub-sections 26(1)
and (2)
was to read them together as indicating that all constraints upon
economic activity and the earning of livelihood which
fall outside
the purview of sub-section 26(2) were in breach of section 26.
These are important differences. However,
what is significant
is the rationale for the adoption of the rational basis test.
[85]
The rationale for the adoption of the rationality test in the
Lawrence
case, appears from the following passage:
“
To maintain the
proper balance between the roles of the Legislature and the courts s
26(2) should be construed as requiring only
that there be a rational
connection between the legislation and the legislative purpose
sanctioned by the section . . . The
rational basis test fits
the language of the section which, unlike s 33, sets as the criterion
that the measures must be justifiable
in an open and democratic
society based on freedom and equality, but does not require in
addition to this that the measure be reasonable.
The
proportionality analysis which is required to give effect to the
criterion of “reasonableness” in s 33 forms no
part of a
s 26 analysis.”
[82]
(footnote omitted)
[86]
As the
Lawrence
case makes it plain, the Court sought to
achieve a proper balance between the role of the legislature on the
one hand, and the
role of the courts on the other. The rational
basis test involves restraint on the part of the Court. It
respects the
respective roles of the courts and the legislature.
In the exercise of its legislative powers, the legislature has the
widest
possible latitude within the limits of the Constitution.
In the exercise of their power to review legislation, courts should
strive to preserve to the legislature its rightful role in a
democratic society. It is this guiding principle that should
inform the test for determining whether legislation that regulates
practice but does not, objectively viewed, impact negatively
on
choice, passes constitutional scrutiny.
[87]
It is
necessary in this regard to consider the approach of the German
Court. As pointed out earlier, article 12(1) of
the Basic Law
is almost identical to our section 22. Like our section 22 it
provides that (a): all Germans have the right
freely to choose their
profession; and (b) its second sentence provides that the practice of
a profession may be regulated by law.
[83]
And as pointed out earlier, the German Court has construed article
12(1) as comprehending a unitary right of freedom of occupational
activity that embraces both the choice and practice of a
profession.
[84]
[88]
The
starting point of the German Court is the recognition of the
difficulty of drawing a clear distinction between regulation
that
affects choice of a profession on the one hand and regulation that
affects practice on the other. It held that article
12(1)
“grants the legislature the power to make regulations affecting
either the choice or the exercise of an occupation.”
[85]
However, the court held that the legislature may not regulate the
right to choose a profession to the same degree that it
regulates the
right to practise a profession. The scope of the regulation is
narrower where the regulatory power is directed
at the right to
choose. Where the regulatory power is directed at the right to
practise a profession, the scope of regulation
is wide. In this
regard the court reasoned thus:
“
For
it is clear from the text of Article 12(1) that occupational choice
is to remain ‘free’ while the practice
of an
occupation may be regulated. This language does not permit an
interpretation that assumes an equal degree of legislative
control
over each of these ‘aspects.’ The more legislation
affects the choice of a profession, the more limited
is the
regulatory power.
. . . .
The
legislature is thus empowered to make regulations affecting either
the choice or the practice of a profession. The more
a
regulatory power is directed to the choice of a profession, the
narrower are its limits; the more it is directed to the practice
of a
profession, the broader are its limits”.
[86]
[89]
The
German Court has developed what is called “the gradation theory
(Stufentheorie)”
[87]
as
a standard for determining whether regulation of choice or practice
is permissible under article 12(1). This theory establishes
varying degrees of judicial review according to the degree of
intrusion. It laid down the general principles governing this
theory and said:
“
The practice of an
occupation may be restricted by reasonable regulations predicated on
considerations of the common good.
The freedom to choose an
occupation, however, may be restricted only for the sake of a
compelling public interest; that is, if,
after careful deliberation,
the legislature determines that a common interest must be protected,
then it may impose restrictions
in order to protect that interest –
but only to the extent that the protection cannot be accomplished by
a lesser restriction
on freedom of choice. In the event that an
encroachment on freedom of occupational choice is unavoidable,
lawmakers must
always employ the regulative means least restrictive
of the basic right.”
[88]
[90]
The
German Court made a distinction between a law that regulates practice
and one that regulates choice. It held that
the practice of an
occupation may be limited “by reasonable regulations predicated
on considerations of the common good.”
[89]
It added “[l]awmakers are freest when they regulate the
practice of an occupation.”
[90]
They may impose limitations on the right to practise a profession in
order to prevent danger to the general public.
[91]
The individual is protected “only against excessively onerous
and unreasonable encroachments.”
[92]
By contrast where the regulation infringes on choice of an
occupation, “the restrictive measures selected must entail
the
least possible interference.”
[93]
Implicit in the adoption of reasonableness as the standard for
determining whether legislation under challenge falls within
the
purview of article 12(1), is the requirement of proportionality.
[94]
[91]
The
similarities between section 22 of our Constitution and article 12(1)
of the Basic Law make the German approach somewhat
attractive.
[95]
However, it is our Constitution that is being construed. It
must be construed in the light of our constitutional scheme
and our
jurisprudence. As pointed out earlier, under our jurisprudence,
the exercise of legislative and executive power is
subject to two
constraints, namely, the minimum threshold requirement of rationality
and that it must not infringe any of the rights
contained in the Bill
of Rights. If exercise of power limits any such rights, it must
pass the section 36(1) test.
And proportionality analysis is
central to the section 36(1) enquiry.
[92]
Under our constitutional scheme, the proportionality analysis is
required to give
effect to the criterion of reasonableness in section
36(1). To require reasonableness, and thus the proportionality
analysis,
in the context of section 22 would be to ignore the
language of section 22. It is clear from the text of the
provision that
choice and practice are not to be regulated to the
same extent. Where the regulation, viewed objectively, would
have a negative
impact on choice, the regulation must be tested under
section 36(1). In other cases, the test is one of rationality.
[93]
That said, however, the scope of permissible regulation that we adopt
here is not
entirely inconsistent with the German approach. It
recognises that it is not always possible to draw a clear line of
distinction
between regulation that affects the practice of a
profession on the one hand and one that affects choice on the other.
It
requires that where, objectively viewed, the regulation of the
practice of a profession impacts negatively on choice such regulation
must be tested under section 36(1). Such regulation does not
fall within the purview of section 22, and must therefore meet,
amongst other requirements, the standard of reasonableness, of which
proportionality analysis is an important component.
The same
standard must be met where the regulation of the practice of a
profession limits any of the rights in the Bill of Rights.
However where, as here, the regulation, objectively viewed, does not
impact negatively on choice, it need only satisfy the rationality
test. In the result, restrictions on the right to practise a
profession are subject to a less stringent test than restrictions
on
the choice of a profession.
[94]
Where, as here, the Constitution gives the power to regulate a right,
not every regulation
of that right amounts to a limitation of the
right in question. But at the same time Parliament may not
unconstitutionally
limit the right to practise a profession under the
guise of regulating it. Where the regulation of the right
amounts to a
limitation of that right, such a limitation will have to
be tested under section 36(1). In this case we are concerned
with
regulation that merely regulates in the sense of facilitating
the proper exercise of the right to practise a profession. It
does not limit the right to practise. The applicants did not
contend otherwise.
[95]
The question that falls to be determined, therefore, is whether the
linking of a
licence to dispense medicines to particular premises is
rationally related to the government purpose of increasing access to
medicines
that are safe for consumption. It is to that question
that I now turn.
Is
the linking of a licence to dispense medicines rationally related to
the governmental objective to increase access to medicines
that are
safe for consumption?
[96]
As pointed out earlier, the conditions under which medicines are kept
and stored
are essential to the safety of medicines. Medicines
must be stored under the recommended conditions to ensure their
efficacy
and safety. The premises where they are kept must
therefore be suitable for compounding and dispensing medicines in
accordance
with good dispensing practice. The requirement that
dispensing medical practitioners must dispense medicines from
particular
premises facilitates regular inspection of those premises
for compliance with good dispensing practice. The applicants
did
not contend otherwise.
[97]
The applicants accept that the storage of medicines and the
appropriateness of the
premises from which medicines are dispensed
require regulation and control in the public interest. In its
comment on the
draft Regulations, the second applicant stated that it
“recognises the need for adequate dispensing controls and
conditions,
and supports the government’s goals to ensure that
high quality and appropriate medicines are safely distributed from
clean
and suitably equipped dispensing premises by properly trained
dispensers.” In addition, in a letter of 2 October 1996,
the second applicant stated that it “supports the regular
inspection of premises to ensure that Good Dispensing Practice
is
maintained.” These comments on behalf of the applicants
underscore the importance of the need to ensure that medicines
are
dispensed from premises that are subject to control and regular
inspection. Such regular inspection can effectively be
conducted if the premises from which medicines are dispensed are
known.
[98]
In addition, in written argument on behalf of the applicants, it is
made clear that:
“
[The
applicants] also have no objection to a condition being stipulated
that dispensing doctors should be required to comply with
a Code of
Good Dispensing Practice which would deal with the requirements
relating to the premises from which such dispensing takes
place.
Such Code of Good Dispensing Practice would deal with the
requirement,
inter alia
, of keeping and storing medicines,
keeping of various statutory registers, the disposal of expired
medicines, etc and also with
the requirements relating to the
premises from which such dispensing takes place. It should be
noted that the applicants
have always supported the fact that the
premises from which dispensing takes place should conform to certain
standards and indeed
that such premises should be inspected and
licensed on a regular basis. This licence, should however be
separate from the
licence to dispense. The licence to dispense
recognises competency while the licence for a dispensary deals with
physical
and statutory requirements. Such a split would solve
the problem of a doctor, or doctors with satellite practices, from
having
to apply for a licence to dispense for each practice, instead
of a licence to dispense which would be issued to the person, and
a
‘dispensary’ licence for each place of dispensing.”
[99]
But the applicants seem to prefer that two separate licences be
issued, one for the
dispensing medical practitioner and the other for
the premises. “Such a split”, they submit, “would
solve
the problem of a doctor or doctors with satellite practices,
from having to apply to have a licence to dispense for each
practice”.
But they are wrong in assuming that such
doctors will have to apply separately for each practice. A
medical practitioner
with satellite practices will be issued with a
single licence reflecting all the premises from which he or she will
be dispensing
medicines. And whenever a medical practitioner
wishes to expand his or her practice to other premises, such medical
practitioners
will have to apply for the addition of those premises
to his or her licence as premises from which medicines will be
dispensed
as well.
[100]
In all the circumstances, I conclude that linking the licence to
dispense medicines to particular
premises is rationally connected to
the government objective to increase access to medicines that are
safe for consumption by the
public. This kind of regulation
falls within the purview of section 22.
[101]
The applicants contended further that the linking of a licence
to particular premises also infringes
the rights to dignity, freedom
of movement and property.
The
challenge based on the infringement of other constitutional rights
[102]
The applicants contended that the requirement to apply for a new
licence whenever a medical practitioner
is moving to new premises
interferes with the freedom of movement. I think that it can be
accepted that the right to practise
a profession includes the right
to decide where one will practise one’s profession. This
being a right relating to
the practice of a profession, it is subject
to regulation under section 22. The requirement of a licence
does not take away
the right to choose where to practise medicine.
But what it does is merely to require that if the practice is to
involve
compounding and dispensing of medicines, this should be done
from premises in respect of which a licence to dispense medicines has
been issued. This does not infringe the right to freedom of
movement as contemplated in section 21 of the Constitution.
Nor
does this infringe any property rights of the applicants as
contemplated in section 25.
[103]
There is
nothing in the regulations to suggest that medical practitioners will
be prevented from practising their profession from
wherever they
choose. It is true sub-regulation 18(5)(a) requires the
Director-General to have regard, among other factors,
to the
existence of other health care providers in the vicinity of the
premises from where an applicant for a licence intends to
dispense
medicines. The applicants contended that this provision will be
used to refuse licences where there are pharmacies
in the area
concerned. The respondents disavowed this. According to
the respondents the existence of pharmacies in
the vicinity and the
geographical limits will not be impediments to the granting of a
licence. Sub-regulation 18(5)(a) is
dealt with more fully
below.
[96]
[104]
Nor does the licensing scheme infringe the right to the dignity of
medical practitioners. I
cannot conceive of anything that would
harm the medical profession if those medical practitioners who wish
to dispense medicines
as part of their practices are required to
comply with good dispensing practice in order to promote access to
medicines that are
safe for consumption by the public. If
anything, this should enhance their dignity in the eyes of the public
that they serve.
[105]
The constitutional challenges based on the infringement of the rights
to freedom of movement, dignity
and property must therefore fail.
Are
the impugned provisions of the regulations void for vagueness?
[106]
The applicants also directed the challenge based on vagueness at
certain provisions of regulation
18(3) and (5), which provide:
“
LICENCE
TO DISPENSE OR COMPOUND AND DISPENSE MEDICINES
(3)
The application shall contain at least the following information:
(a)
the name and both residential and business addresses (both physical
and postal) of the applicant;
(b)
the exact location of the premises where compounding and/or
dispensing will be carried out;
. . .
(d)
telephone and fax numbers of the applicant, where available;
(e)
proof of registration with the relevant statutory council;
(f)
proof of publication of the notice contemplated in subregulation (6);
(g)
motivation, as to the need for a licence in a particular area;
(h)
any other information that the Director-General may require; and
(i)
proof of ability to supply a patient information leaflet.
. . .
(5)
In considering an application referred to in subregulation (1), the
Director-General shall have regard to the following:
(a)
the existence of other licensed health facilities in the vicinity of
the premises from where the compounding and dispensing
of medicines
is intended to be carried out;
(b)
representations, if any, by other interested persons as to whether a
licence should be granted or not;
(c)
the geographic area to be served by the applicant;
(d)
the estimated number of health care users in the geographic area
referred to in paragraph (c);
(e)
demographic considerations including disease patterns and health
status of the users to be served; and
(f)
any other information that he or she deems necessary.
(6)
At the same time when an application referred to in subregulation (1)
is made, the applicant must also give notice by publication
in a
newspaper circulating in the area where the applicant intends to
conduct his or her practice of his or her intention to apply
for a
licence.
(7)
Any person may support or oppose an application referred to in
subregulation (1) by making written representations to the
Director-General
within 30 days of publication of the notice
contemplated in subregulation (6).”
[107]
The argument went as follows: The impugned provisions require the
Director-General to make a decision
based on factors that are not
objectively ascertainable. The consequence of this is that the
Director-General is authorised
to make decisions that are arbitrary
because the Director-General is not given guidance as to how to
exercise the powers conferred
on him or her. The impugned
provisions of the regulation are therefore in breach of the principle
of legality by reason of
vagueness. It was also contended that
the provisions of the regulations provide a framework for the refusal
of a licence
where there are pharmacies in the vicinity. The
challenge to regulation 18(3) is related to the challenge to
regulation 18(5).
It will be convenient to deal first with
regulation 18(5).
The
challenge to sub- regulation 18(5)
[108]
Sub-regulation
18(5) was challenged on the basis that it is vague and does not
conform to the principle of legality. The doctrine
of vagueness
is one of the principles of common law that was developed by courts
to regulate the exercise of public power.
As pointed out
previously, the exercise of public power is now regulated by the
Constitution which is the supreme law. The
doctrine of
vagueness is founded on the rule of law, which, as pointed out
earlier, is a foundational value of our constitutional
democracy.
It requires that laws must be written in a clear and accessible
manner.
[97]
What is
required is reasonable certainty and not perfect lucidity.
[98]
The doctrine of vagueness does not require absolute certainty of
laws. The law must indicate with reasonable certainty
to those
who are bound by it what is required of them so that they may
regulate their conduct accordingly.
[99]
The doctrine of vagueness must recognise the role of government to
further legitimate social and economic objectives.
And should
not be used unduly to impede or prevent the furtherance of such
objectives. As the Canadian Supreme Court observed
after
reviewing the case law of the European Court of Human Rights on the
issue:
“
Indeed
. . . laws that are framed in general terms may be better suited to
the achievement of their objectives, inasmuch as in fields
governed
by public policy circumstances may vary widely in time and from one
case to the other. A very detailed enactment
would not provide
the required flexibility, and it might furthermore obscure its
purposes behind a veil of detailed provisions.
The modern state
intervenes today in fields where some generality in the enactments is
inevitable. The substance of these
enactments remains
nonetheless intelligible. One must be wary of using the
doctrine of vagueness to prevent or impede state
action in
furtherance of valid social objectives, by requiring the law to
achieve a degree of precision to which the subject-matter
does not
lend itself. A delicate balance must be maintained between
societal interests and individual rights. A measure
of
generality also sometimes allows for greater respect for fundamental
rights, since circumstances that would not justify the
invalidation
of a more precise enactment may be accommodated through the
application of a more general one.”
[100]
(citations omitted)
[109]
Where, as
here, it is contended that the regulation under consideration is
vague for uncertainty, the court must first construe
the regulation
applying the normal rules of construction
[101]
including those required by constitutional adjudication.
[102]
The ultimate question is whether so construed, the regulation
indicates with reasonable certainty to those who are bound
by it what
is required of them.
[110]
Does
sub-regulation 18(5) convey a reasonably certain meaning to those who
are affected by it?
[103]
[111]
Sub-regulation
18(5) sets out factors to which the Director-General must have regard
in considering an application for a licence.
The provisions of
this sub-regulation require the Director-General in considering an
application for a licence, to have regard
to, among other factors,
the existence of other licensed health facilities in the vicinity of
the premises from where the compounding
and dispensing of medicines
is intended to be carried out,
[104]
the geographic area to be served by the applying medical
practitioner,
[105]
the
estimated number of health care users in the geographic area to be
served by the applying medical practitioner
[106]
and the demographic considerations including the disease patterns and
health status of the users to be served.
[107]
These factors have to be taken into consideration when deciding
whether to refuse or issue a licence to dispense medicines.
They are formulated in unambiguous terms. There is no room for
any doubt about what those factors are. They tell the
Director-General what factors he or she is required to have regard to
in deciding an application for a licence to dispense medicines.
In these circumstances the provisions of sub-regulation 18(5) cannot
be said to be vague.
[112]
As I see it, the problem with sub-regulation 18(5) lies elsewhere.
The applicants contended
that the provisions of sub-regulation were
intended to provide a framework for refusing a licence where there
are pharmacies in
the vicinity of the premises from where an
applicant intends to dispense medicines in line with the government’s
National
Drug Policy (NDP). The policy on the licensing of
health practitioners and premises is described as follows in the NDP:
“
Only
practitioners who are registered with the relevant Council and
premises that are registered and/or licensed in terms of the
Medicines and Related Substances Control Act (No 101 of 1965) may be
used for the manufacture, supply and dispensing of drugs.
Medical practitioners and nurses will not be permitted to dispense
drugs, except where separate pharmaceutical services are not
available. In such instances/situations where dispensing by
doctors and nurses has to take place, such persons will be in
possession of a dispensing licence issued by the Medicine Control
Council. Criteria for the granting of such licences will
include
inter alia
, the application of
geographical limits.
Special concessions will be granted
with regard to certain categories of providers such as occupational
health services.
Proven competency of such persons to dispense
drugs will be by virtue of the successful completion of a suitable
training programme.
All licences will be reviewed and renewed
annually. These inspection functions will be delegated to the
provinces.”
(underlining added)
[113]
In response to these allegations, the Director-General who deposes to
the affidavits on behalf of
the respondents denied the existence of a
policy to refuse licences where there are pharmacies in the
neighbourhood. It is
allege that the purpose of the provisions
of sub-regulation 18(5) is, among other things, to provide the
Director-General with
some idea as to what particular areas are being
serviced by medical practitioners who dispense medicines. This
was said to
be necessary to “enhance the scope for efficient
utilisation of resources . . . [and] allow the government to plan and
implement
its health programme more effectively”. The
Director-General has disavowed any intention of using geographical
area
or proximity to a pharmacy as a basis for refusing a licence,
adding that “the geographical area where the medical
practitioner
intends to dispense medicines from is no impediment to
obtaining a licence”. However, nothing is said about the
NDP
or the apparent contradiction between the denial of the existence
of policy to deny licences where there is a pharmacy in the
neighbourhood
and the policy contained in the NDP which suggests that
medical practitioners will not be issued with licences where there
are
pharmacies in the neighbourhood.
[114]
The response by the on behalf of the respondents leaves a good deal
to be desired. In the first
place, the provisions of
sub-regulation 18(5) were intended to provide guidance to the
Director-General in deciding whether to
grant a licence, by providing
him or her with factors to which regard must be had. These
factors could not have been intended
to provide the Director-General
with mere information as suggested on behalf of the respondents.
Were this to have been the
case, these factors would have been
elsewhere in the regulations than in a provision that contains
factors that are intended to
influence a decision whether or not to
grant a licence. Both the language of sub-regulation 18(5) and
the context in which
it occurs, simply do not admit of such a
construction. The purpose of this provision must be determined
in the light of its
language and the context in which it occurs.
[115]
In addition, the applicants have squarely raised the NDP and, in
particular, the aspect that provides
that medical practitioners will
not be issued with a licence to dispense medicines where there are
pharmacies in the neighbourhood.
The applicants have relied
upon this policy to challenge sub-regulation 18(5). Although
not said in so many words, there
can be no question that the present
litigation has a lot to do with the fear that medical practitioners
will be denied licences
where there are pharmacies in the
neighbourhood. What is more, there is a clear contradiction
between the policy as stated
in the NDP and the allegations made on
behalf of the respondents that there is no policy to deny a licence
to medical practitioners
where there are pharmacies in the
neighbourhood.
[116]
These matters called for a direct response from the respondents.
The Court is now left to speculate
on why the respondents neither
deny the existence of the NDP nor explain the obvious contradiction
between the denial of the existence
of the challenged policy and the
policy as articulated in the NDP. In my view, this
contradiction is inexplicable except
on the basis that the deponent
to the opposing affidavit on behalf of the respondents was either not
entirely candid with the Court
or that the respondents have backed
down on their initial policy as stated in the NDP. If the
latter is true, it is difficult
to understand why this explanation
was not given by the respondents. Be that as it may, the matter
must be approached on
the footing that at all material times, and, in
particular, until the opposing affidavits were filed, the respondents
had a policy
of denying licences to medical practitioners where there
are pharmacies in the neighbourhood.
[117]
The NDP makes clear that “[m]edical practitioners and nurses
will
not be permitted to dispense drugs, except where separate
pharmaceutical services are not available.” For medical
practitioners
and nurses to dispense medicines “[i]n such
instances/situations”, they will have to be in possession of
dispensing
licences. And more importantly, “[c]riteria
for the granting of such licences will include
inter alia
, the
application of geographical limits.” The need to have
regard to the existence of other health facilities in the
vicinity
was intended to give effect to this policy. The geographic and
demographic considerations provide criteria for implementing
the
policy of denying licences to medical practitioners and nurses where
there are pharmacies in the vicinity of the premises from
which a
medical practitioner intends to dispense medicines. It is in
the light of this policy that the provisions of sub-regulation
18(5)
must be understood and construed.
[118]
Properly construed, the manifest purpose of sub-regulation 18(5) is
to limit the rights of medical
practitioners to dispense medicines
where there are pharmacies in the neighbourhood. This purpose
is consistent with the
NDP which makes it clear that: (a) medical
practitioners will not be issued with licences where there are
pharmacies in the neighbourhood;
(b) to dispense medicines in such
situations, medical practitioners will have to be issued with
licences; and (c) criteria for
the granting of such licences will
include the geographical limits. And such criteria are apparent
from the factors which
sub-regulation 18(5)(a), (c), (d) and (e)
direct the Director-General to have regard to in considering
licences, namely, the existence
of pharmacies in the neighbourhood,
the geographical area to be served by the applying medical
practitioner, the estimated number
of health care users in the
geographical area to be served by the applying medical practitioner
and the demographic considerations
including the disease patterns and
health status of users to be served.
[119]
The purpose of sub-regulation 18(5)(a), (c), (d) and (e) is
manifestly to protect pharmacies against
competition from medical
practitioners and nurses. This purpose is not discernable from
the Medicines Act. Nothing
in the Medicines Act empowers the
Minister to develop such a policy through the Regulations. It
follows therefore that the
provisions of sub-regulation 18(5)(a),
(c), (d) and (e) that develop the policy of denying a licence where
there are pharmacies
in the neighbourhood are
ultra vires
the
empowering statute.
[120]
There is a further reason why the provisions of sub-regulation
18(5)(a), (c), (d) and (e) are bad.
What the respondents are in
fact saying is that notwithstanding the requirement that the
Director-General must have regard to these
factors in deciding
whether to grant a licence, the Director-General may not refuse a
licence on the basis of these factors.
These factors are not
there to assist the Director-General to decide whether to issue or
refuse a licence. They have got
nothing to do with whether a
licence should be issued or not. They are there for a different
purpose: to “allow the
government to plan and implement its
health programmes more effectively.”
[121]
But there is nothing in sub-regulation 18(5) that tells the public or
Director-General that a licence
may not be refused on the basis of
these factors. On the contrary, the impression created is that
they are relevant considerations,
hence the pharmacies have been
relying on these provisions to raise objections to licences, but
without success. As pointed
out earlier, laws, including
regulations, must be formulated in an accessible manner. They
must indicate with reasonable
certainty to those who may be affected
by the exercise of the power to grant or refuse a licence, what is
relevant to the exercise
of that power or in what circumstances they
may seek relief. From what the respondents now say, the
provisions of sub-regulation
18(5)(a), (c), (d) and (e) cannot be
said to meet this standard.
[122]
In addition, once it is accepted, as it must be, in the light of the
denial by the respondents, that
the existence of pharmacies in the
vicinity and the geographical limits are impediments to obtaining a
licence, then the need to
have regard to the existence of other
health care providers in the vicinity, geographical limits and
demographic considerations,
before a licence can be issued falls
away. They no longer serve any purpose which explains why
objections based on them were
simply ignored by the
Director-General. Indeed counsel for the respondents was unable
to suggest any other reason for the
existence of sub-regulation
18(5)(a). None suggests itself. It is a relic of a
discarded policy. It should have
been discarded likewise.
The same goes for sub-regulation 18(5)(c), (d) and (e) which were
designed to provide criteria for
implementing the discarded policy.
[123]
For all these reasons, sub-regulation 18(5)(a), (c), (d) and (e) are
ultra vires
the empowering statute and are accordingly
unconstitutional. This conclusion renders it unnecessary to
decide whether these
provisions, to the extent that they protect
pharmacies against competition from medical practitioners, constitute
a limitation
of section 22 of the Constitution. The appropriate
remedy is to strike down these provisions. The provisions of
sub-regulation
18(5)(a), (c), (d) and (e) form a discrete cluster
that may easily be severed from the rest of the regulations without
destroying
the licensing scheme. What is left behind passes
constitutional muster.
[124]
Different considerations apply to the provisions of sub-paragraph (b)
and (f) of sub-regulation 18(5).
They have broad application.
They must be read together as permitting the Director-General to have
regard to representations
by interested persons as to whether a
licence should or should not be granted. These provisions
perform an important public
interest function by allowing interested
persons to place before the Director-General information that might
assist him or her
to decide whether or not to grant a licence.
[125]
Sub-paragraph (b) of regulation 18(5) allows the Director-General the
opportunity to receive representations
from interested persons as to
why a licence should or should not be granted. And there is
nothing vague about the phrase
“interested persons”.
All members of the public are potential patients and are therefore
interested persons.
An interested person is easily
ascertainable. It follows that the attack on sub-regulation
18(5)(b) must fail.
[126]
Sub-paragraph (f) of sub-regulation 18(5) allows the Director-General
to take into consideration “any
other information that he or
she deems necessary”. The applicants submitted that this
provision is arbitrary and gives
no guidelines or norms to guide the
Director-General. This provision no doubt gives the
Director-General broad discretion
in deciding what information to
consider. As pointed out earlier, discretion plays an important
role in any legal system.
It permits abstract and general rules
to be applied to specific and particular circumstances in a fair
manner. Where, as
here, factors that are relevant to the
exercise of the discretion are clear, discretionary powers may be
broadly formulated.
In addition, the discretionary powers of
the Director-General are constrained by the objectives of the
Medicines Act, namely, to
increase access to medicines that are safe
for consumption. It follows therefore that the challenge to
sub-paragraph (f)
of sub-regulation 18(5) must fail.
The
challenge to sub-regulation 18(3)
[127]
The applicants did not suggest that sub-regulation 18(3) is vague.
Instead the applicants contended
that the information required by
sub-regulation 18(3)(b), (f) and (g) must be evaluated in the light
of the provisions of sub-regulation
18(5)(a)-(e) which sets out the
factors to which the Director-General must have regard in deciding
whether to grant a licence.
They contended that these
provisions were included in the regulations to create a framework for
refusing applications for licences
where there are pharmacies in the
vicinity of the area where an applicant intends to dispense
medicines. This is in line
with the respondents’
originally stated intention, the applicants submitted.
[128]
Whatever the original intention of the respondents was, the
provisions of sub-regulation 18(5)(a),
(c), (d) and (e) have been
found to be unconstitutional and they cannot be relied upon to deny a
licence. This being the
case, the challenge to sub-regulation
18(3) falls away.
The
challenge to sub-regulations 18(6) and (7)
[129]
The provisions of sub-regulations 18(6) and (7) must be read together
with the provisions of sub-regulation
18(5)(b) and (f). Once it
is accepted, as it must be, that there is a need to permit interested
people to make available
to the Director-General information which is
relevant to whether a licence should or should not be granted, there
must be a mechanism
for informing the public of the pending
applications for licences to enable them to comment on them.
Sub-regulation 18(6)
provides that mechanism by requiring an
applicant for a licence to publish a notice of intention to apply for
a licence, while
sub-regulation 18(7) permits anyone to make
representations to the Director-General supporting or opposing the
applications.
These provisions have been formulated with
sufficient clarity to enable those affected by them to know what is
expected of them.
[130]
These provisions serve an important public interest in that they
enable any person who has information
that might be relevant to the
granting or refusal of the licence, to make such information
available to the Director-General for
a proper decision. The
regulations are silent on whether such information should be made
available to the applicant.
There can be no question that, if
the Director-General intends to rely on information adverse to an
applicant, fairness will require
the Director-General to afford the
applicant the opportunity to comment on such information.
[131]
In all the circumstances, the challenge to sub-regulations 18(6) and
(7) must fail.
The
challenge to regulation 20
[132]
The
applicants mounted a challenge to regulation 20 based on freedom of
movement and residence. They also contended that the
period of
three years for which a licence must be renewed is arbitrary.
This regulation provides that a licence is valid
for three years but
may be renewed after its expiry. It is authorised by section
22D of the Medicines Act which makes provision
for the renewal of
licences.
[108]
The
section does not stipulate the period of the validity of the licence.
[133]
Regulation 20 provides:
“
PERIOD
OF VALIDITY OF A LICENCE ISSUED IN TERMS OF REGULATIONS 18 AND 19 AND
RENEWAL OF LICENCES
20.
(1) A licence issued in terms of regulation 18 shall be valid for a
period of 3 years whereas a licence issued in terms of regulation
19
shall be valid for a period of 5 years from the date of issue.
(2)
A licence referred to in subregulation (1) which has expired may be
renewed upon application to the Director-General or the
Council, as
the case may be.
(3)
An application referred to in subregulation (2) shall –
(a)
contain at least the information or documentation referred to in
regulations 18(3) and 19(1)(c), as the case may be;
(b)
be accompanied by a prescribed fee; and
(c)
be made at least 90 days before the expiry of the existing licence.”
[134]
There is nothing arbitrary about requiring medical practitioners to
renew their licences to dispense
medicines. The applicants
themselves support the requirement that a dispensing medical
practitioner obtain a certain number
of Continuous Professional
Development (CPD) points in respect of dispensing. They say
that this would ensure that dispensing
medical practitioners remain
up to date with current practices as is required in other areas of
medical practitioners’ scope
of practice. But the same
result can be achieved by requiring the renewal of licences. Nor does
this requirement infringe
the freedom of movement. The
challenge to regulation 20 must likewise fail. Before dealing
with the question of costs,
it is necessary to deal with the
application to lead further evidence.
Application
for leave to lead further evidence
[135]
Shortly before the hearing of this matter the applicants sought leave
to lead further evidence.
There is a current tendency to tender
further evidence on appeal only days before an appeal hearing.
To this tendency, this
Court has remarked:
“
It
is appropriate to note that it has become a regrettable practice in
this Court that affidavits are tendered on appeal often only
days
before an appeal hearing, if not on the day of the appeal itself.
This is an unacceptable practice which must be discouraged.
The
late filing of affidavits in circumstances which do not meet the
stringent test for admission set out in this judgment will
not be
permitted by this Court. Attorneys should take care to consider
the test for the admission of late affidavits and
satisfy themselves
before filing the affidavits that they do qualify for admission in
terms of the rules of this Court and the
principles elucidated in
this judgment.”
[109]
[136]
Further
evidence on appeal will only be admitted in exceptional
circumstances.
[110]
Recently, this Court has said:
“
The
Court should exercise the powers conferred by section 22 ‘sparingly’
and further evidence on appeal (which does
not fall within the terms
of rule 31) should only be admitted in exceptional circumstances.
Such evidence must be weighty,
material and to be believed. In
addition, whether there is a reasonable explanation for its late
filing is an important factor.
The existence of a substantial
dispute of fact in relation to it will militate against its being
admitted.”
[111]
[137]
The evidence sought to be introduced included a dispensing licence
issued to Dr Ahmed. The respondents
did not object to this
evidence in so far as it introduced the licence issued to Dr Ahmed.
Nor did they dispute the accuracy
of the contents of the licence.
The evidence relating to the dispensing licence issued to Dr Ahmed
was not only credible
and material, it was not disputed by the
respondents. Its admission, therefore, would not result in any
prejudice to the
respondents. As would have been apparent from
this judgment, that evidence was relevant to the issues that had to
be decided.
In these very exceptional circumstances, the
evidence relating to the dispensing licence issued to Dr Ahmed ought
to be received
into evidence. The rest of the evidence tendered
does not meet the test for the admission of further evidence and
cannot
therefore be admitted.
Costs
[138]
The award
of costs is a matter which is within the discretion of the court
considering the issue of costs. It is a discretion
that must be
exercised judicially having regard to all the relevant
considerations. One such consideration is the general
rule in
constitutional litigation that an unsuccessful litigant ought not to
be ordered to pay costs. The rationale for this
rule is that an
award of costs might have a chilling effect on the litigants who
might wish to vindicate their constitutional rights.
But this
is not an inflexible rule. There may be circumstances that
justify departure from this rule such as where the litigation
is
frivolous or vexatious. There may be conduct on the part of the
litigant that deserves censure by the court which may
influence the
court to order an unsuccessful litigant to pay costs. The
ultimate goal is to do that which is just having
regard to the facts
and circumstances of the case. In
Motsepe
v Commissioner for Inland Revenue
[112]
,
this Court articulated the rule as follows:
“
[O]ne should be
cautious in awarding costs against litigants who seek to enforce
their constitutional right against the State, particularly
where the
constitutionality of the statutory provision is attacked, lest such
orders have an unduly inhibiting or ‘chilling’
effect on
other potential litigants in this category. This cautious
approach cannot, however, be allowed to develop into
an inflexible
rule so that litigants are induced into believing that they are free
to challenge the constitutionality of statutory
provisions in this
Court, no matter how spurious the grounds for doing so may be or how
remote the possibility that this Court
will grant them access.
This can neither be in the interests of the administration of justice
nor fair to those who are forced
to oppose such attacks.”
[113]
[139]
In awarding costs against the applicants, the High Court noted that
the applicants were not indigent
persons. In addition, it noted
that they were “in a position to finance the litigation which
they pursued ‘with
vigour’”. While accepting
that as a general matter an unsuccessful litigant in constitutional
litigation should
not be ordered to pay costs, the court concluded
that in the circumstances of this case it would not be unfair to
order the applicants
to pay costs. The court was no doubt
influenced by both the vigour with which they pursued the litigation
and their perceived
ability to pay. The court erred in this
regard. The court did not pay sufficient account to the general
rule in constitutional
litigation referred to above. The fact
that the litigant has pursued litigation with vigour is not a
material consideration.
Nor is the ability to finance the
litigation a relevant consideration. This litigation cannot be
described as vexatious or
frivolous. On this basis alone the
order for costs made by the High Court ought to be set aside.
But there is the further
reason why it should be set aside, namely
that the applicants have been partially successful.
[140]
It is true that the applicants have partially succeeded. But
there are other considerations
that are relevant to this enquiry.
The applicants’ main argument, and to which they devoted a
great deal of time, was
based on coupling. As pointed out
earlier in this judgment, counsel for the applicant made it quite
clear that the applicants
were in court because of coupling. On
this issue we have found against them. In addition, they also
attacked the provisions
of sub-section 22C(1)(a) of the Medicines
Act. They also failed in this regard. Nor should one lose
sight of the fact
that initially the attack was directed against the
licensing provisions of the Medicines Act, but this attack was later
abandoned.
These matters cannot be ignored in determining what
the appropriate order for costs is. In my view, in all the
circumstances
of this case, fairness dictates that there should be no
order for costs both in this Court and in the High Court.
Disposition
of the matter
[141]
It is apparent from this judgment that the application for leave to
appeal not only raised important
constitutional questions relating to
the scope of permissible regulation under section 22 of the
Constitution and the principles
governing the doctrine of legality,
but it had some prospects of success. In all the circumstances,
the application for leave
to appeal should be granted. The
appeal succeeds to the extent that sub-regulation 18(5)(a), (c), (d)
and (e) are declared
unconstitutional.
Order
[142]
In the event, the following order is made:
(a) Leave to appeal
is granted.
(b) The appeal is
upheld in part.
(c)
There is no order for costs.
(d)
The order of the High Court is set aside and is replaced with
the
following:
(aa)
The constitutional challenge to sub-section 22C(1)(a) of the
Medicines and Related Substances Act, 101 of 1965
as amended; and
sub-regulations 18(3)(b), (f), (g), (h) and (i); 18(5)(b) and (f);
18(6); 18(7) and
regulation 20
of the Regulations published in
Government Gazette 24727 under Government Notice R510 of 10 April
2003, is dismissed.
(bb)
Sub-paragraphs (a), (c), (d) and (e) of sub-regulation 18(5)of the
said Regulations are declared inconsistent with
the Constitution and
therefore invalid.
(cc)
There will be no order for costs.
Langa
DCJ, Madala, Mokgoro , Moseneke, O’Regan, Sachs, Skweyiya, Van
der Westhuizen, Yacoob JJ concurred in the judgment of
Ngcobo J.
For
the applicants:
HJ
Fabricius SC and SP Mothle instructed by MacRobert Inc.
For
the respondents:
MTK
Moerane SC, P Coppin and B Vally instructed by State Attorney
(Pretoria).
[1]
The members are the: Dispensing Family Practitioners Association;
East Cape Medical Guild; Family Practitioners’ Association;
South African Medical Association; National General Practitioners
Group; South African Managed Care Coalition; South African
Medical
and Dental Practitioners Association; Society of Dispensing Family
Practitioners; National Association of Independent
Practitioner’s
Association; RESMIN; and GP Net.
[2]
Act 56 of 1974. In terms of
section 65
of the
Medical, Dental
and Supplementary Health Service Professions Amendment Act, 89 of
1997
, the Medical, Dental and Supplementary Health Service
Professions Act, 56 of 1974 became known as the Health Professions
Act
56 of 1974.
[3]
Section 38 of the Constitution provides:
“
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.”
[4]
Initially, the applicants sought an order declaring invalid the
requirement that medical practitioners may only dispense medicines
under a licence issued by the Director-General. In addition,
they sought an order declaring invalid: (a) sub-sections 22C(1)(a),
(2), (3), (4), (5) and (7) (which deal with licensing to dispense
medicines), and section 22D (which deals with the renewal of
a
licence to dispense medicines) of the Medicines and Related
Substances Act 101 of 1965 (Medicines Act); (b) regulation 18 of
the
Regulations made under the Medicines Act; and (c) various
proclamations that brought into operation the impugned provisions
of
the Medicines Act and the Regulations, and certain amendments to the
Medicines Act and the Health Professions Act, all of
which brought
about the licensing scheme. However, shortly before the matter
was heard in the High Court, the applicants
substantially narrowed
this relief to the relief they now seek.
[5]
Subsection 22C(1)(a) is reproduced at para 30 below.
[6]
The relevant provisions of regulation 18 and 20 are reproduced at
paras 106 and 133 below.
[7]
Paragraph
(c) of sub-regulation 18 requires the application to contain
information
“
proof
of completion of the supplementary course contemplated in section
22C(2) of the Medicines Act
”
.
This paragraph was not challenged and therefore nothing turns upon
its deletion.
[8]
The new sub-regulation (4) reads as follows:
“
The
application referred to in sub-regulation (1) may be submitted even
before the supplementary course as contemplated in section
22C of
the Act is completed, but a licence may only be issued upon proof
being furnished that such a course has been successfully
completed
and all the other requirements have been met.”
[9]
Satchwell
v President of the Republic of South Africa and Another
[2003] ZACC 2
;
2003
(4) SA 266
(CC);
2004 (1) BCLR 1
(CC) at para 5.
[10]
1995 (2) SA 73
(TK) at 76D-76I. See also
Caxton
Ltd and Others v Reeva Forman (Pty) Ltd and Another
[1990] ZASCA 47
;
1990
(3) SA 547
(A) at 565G-566A.
[11]
See
Moolman
v Estate Moolman and Another
1927 CPD 27
at 29.
[12]
Section 52(2)(b) of the Health Professions Act states:
“
The
registrar shall keep a register in which he shall enter, at the
direction of the council, the name and such other particulars
as the
council may determine of a medical practitioner or dentist—
. . .
(b)
who informs the registrar in the prescribed manner of his intention
to compound or dispense medicine in the practice of his
profession
as contemplated in subsection (1)(a).”
[13]
Section 52(1)(a) of the Health Professions Act. See below n
33.
[14]
Section 52 was repealed by section 50 of the Medical, Dental and
Supplementary Health Service Professions Amendment Act, 89 of
1997,
(Medical Amendment Act of 1997). In terms of Proclamation R26
of 28 March 2003, the provisions of the new section
52 were to come
into operation on 2 May 2004.
[15]
Section 52(1) of the Medical Amendment Act of 1997 provides that:
“
A
medical practitioner, dentist or other person registered in terms of
this Act—
(a)
may compound or dispense medicines only on the authority and subject
to the conditions of a licence granted by the Director-General
in
terms of the Medicines and Related Substances Act, 1965 (Act No. 101
of 1965);
(b)
shall not be entitled to keep an open shop or pharmacy.”
[16]
This amendment was brought about by two separate amendments: the
first amendment by
section 14
of the
Medicines and Related
Substances Control Amendment Act, No. 90 of 1997
, and the second by
sections 6, 7 and 8 of the Medicines and Related Substances Control
Amendment Act, No 59 of 2002. Both
the Medicines Amendment Act
of 1997 and the Medicines Amendment Act of 2002 came into operation
on 2 May 2003, having been brought
into operation by Proclamations
R23 and R24 of 28 March 2003, published in Government Gazette No
24627 of 28 March 2003, respectively.
[17]
This provision is reproduced in full at para 30 below.
[18]
Section 22C(2) of the Medicines Act provides that:
“
A licence
referred to in subsection (1)(a) shall not be issued unless the
applicant has successfully completed a supplementary
course
determined by the South African Pharmacy Council after consultation
with the Health Professions Council of South Africa,
the Allied
Health Professions Council of South Africa and the South African
Nursing Council.”
[19]
Section 22C(5) of the Medicines Act.
[20]
They
are reproduced at para 106 below.
[21]
This
is reproduced at para 133 below.
[22]
This
is reproduced at para 30 below.
[23]
They are reproduced at para 106 below.
[24]
This
is reproduced at para 133 below.
[25]
See
paras 101-105.
[26]
1995
(4) SA 877 (CC); 1995 (10) BCLR 1289 (CC).
[27]
Id at para 51;
Executive
Council, Western Cape v Minister of Provincial Affairs and
Constitutional Development and Another, Executive Council,
KwaZulu-Natal v President of Republic of South Africa and Others
,
[1999] ZACC 13
;
2000 (1) SA 661
(CC);
1999 (12) BCLR 1360
(CC) at paras 123 and 124.
[28]
Dawood
and Another v Minister of Home Affairs and Others; Shalabi and
Another v Minister of Home Affairs and Others; Thomas and
Another v
Minister of Home Affairs and Others
2000 (3) SA 936 (CC); 2000 (8) BCLR 837 (CC).
[29]
Id at 53.
[30]
Id at 47.
[31]
It is by now axiomatic that, where possible, legislation ought to be
construed in a manner that is consistent with the Constitution.
See in this regard:
Zondi
v MEC, Traditional and Local Government Affairs and Others
[2004] ZACC 19
;
2005 (4) BCLR 347
(CC) at para 102;
Bernstein
and Others v Bester and Others NNO
[1996] ZACC 2
;
1996 (2) SA 751
(CC);
1996 4 BCLR 449
(CC) at para 59;
De
Lange v Smuts NO and Others
[1998] ZACC 6
;
1998 (3) SA 785
(CC);
1998 (7) BCLR 779
(CC) at para 85;
S
v Dzukuda and Others; S v Tshilo
2000 (4) SA 1078
(CC);
2000 (11) BCLR 1252
(CC) at para 37(a);
Investigating
Directorate: Serious Economic Offences and Others v Hyundai Motor
Distributors (Pty) Ltd and Others: In re Hyundai
Motor Distributors
(Pty) Ltd and Others v Smit NO and Others
[2000] ZACC 12
;
2001 (1) SA 545
(CC);
2000 (10) BCLR 1079
(CC) at paras 21-26; and
National
Director of Public Prosecutions and Another v Mohamed NO and Others
[2003] ZACC 4
;
2003
(4) SA 1
(CC);
2003 (5) BCLR 476
(CC) at para 35. See also
Olitzki
Property Holdings v State Tender Board and Another
[2001] ZASCA 51
;
2001
(3) SA 1247
(SCA);
2001 (8) BCLR 779
(SCA) at para 20.
[32]
Regulation 18(8) provides:
“
A
person referred to in subregulation (1) who has been issued with a
licence shall:
(a)
keep sales records either in hard copy or electronically relating to
medicines compounded and dispensed for a period of 5
years from the
date of sale;
(b)
ensure that the dispensary and any premises where medicines are kept
are suitable for dispensing or compounding and dispensing
in
accordance with good pharmacy practice;
(c)
keep the medicines under the manufacturer’s recommended
storage conditions as specified on the medicines label and or
package insert;
(d)
not pre-pack medicines at the premises unless authorised to do so by
the Director-General and in terms of regulation 33(a)(ii);
(e)
label medicines properly with the name of the patient and a
reference number linking the patient to a patient record;
(f)
not compound and dispense medicines to patients unless the sale is
preceded by a proper diagnosis and a prescription for a
particular
patient;
(g)
not keep expired medicines on the premises other than in a
demarcated area in a sealed container clearly marked: EXPIRED
MEDICINES and such expired medicines shall be destroyed in terms of
regulation 27;
(h)
secure the premises where the compounding and dispensing is carried
out whenever he or she is not physically present at those
premises;
(i)
in the event of a recall of a medicine, withdraw the medicine;
(j)
conspicuously display the licence in the premises referred to in
paragraph (b); and
(k)
comply with the conditions of his or her licence.”
[33]
The previous section 52 of the Health Professions Act provided:
“
Medical
practitioners and dentists may dispense medicines.— (1)(a)
Every medical practitioner or dentist whose name has
been entered in
the register contemplated in subsection (2) shall, on such
conditions as the council may determine in general
or in a
particular case, be entitled to personally compound or dispense
medicines prescribed by himself or by any other medical
practitioner
or dentist with whom he is in partnership or with whom he is
associated as principal or assistant or
locum tenens
, for use
by a patient under treatment of such medical practitioner or dentist
or of such other medical practitioner or dentist:
Provided
that he shall not be entitled to keep an open shop or pharmacy.
(b)
The council may, on such conditions as it may determine, exempt any
medical practitioner or dentist from the requirement of
registration
contemplated in paragraph (a), and may, after an investigation,
withdraw such exemption.
(2)
The registrar shall keep a register in which he shall enter, at the
direction of the council, the name and such other particulars
as the
council may determine of a medical practitioner or dentist—
(a) who within three
months after commencement of the Medical, Dental and Supplementary
Health Service Professions Amendment Act,
1984, submits proof to the
satisfaction of the registrar that at such commencement he
compounded or dispensed medicine as contemplated
in subsection
(1)(a) in the practice of his profession; or
(b)
who informs the registrar in the prescribed manner of his intention
to compound or dispense medicine in the practice of his
profession
as contemplated in subsection (1)(a).
(3)
The council may, after an investigation, direct that the name of any
person be removed from the register contemplated in subsection
(2),
or prohibit him for a specified period from making use of the right
contemplated in subsection (1).
(4)
The council may determine fees to be paid for the entering of a name
in the register contemplated in subsection (2).”
[34]
Sub-r
egulation
18(8)(b).
[35]
Sub-r
egulation
18(3)(b).
[36]
Above n 13.
[37]
Section 1(c) of the Constitution.
[38]
Section 2 of the Constitution.
[39]
Section 172(1)(a) of the Constitution.
[40]
Pharmaceutical
Manufacturers Association of SA and Another: In re Ex Parte
President of the Republic of South Africa and Others
[2000] ZACC 1
;
2000 (2) SA 674
(CC);
2000 (3) BCLR 241
(CC) at para 20.
[41]
Id at para 17;
Fedsure
Life Assurance Ltd and Others v Greater Johannesburg Transitional
Metropolitan Council and Others
[1998] ZACC 17
;
1999 (1) SA 374
(CC);
1998 (12) BCLR 1458
(CC) at para 58.
[42]
Fedsure
id at
para 58.
[43]
Above
n 40 at para 19.
[44]
Id at para 20.
[45]
Id at para 50.
[46]
Section 35(1)( xxvii) of the Medicines Act.
[47]
Section
35(1)(
xxxvi
)
of the Medicines Act
.
[48]
Section
35(1)
(
xxxiv) of the Medicines Act.
[49]
S
ection
35(1)(
xl
)
of
the Medicines Act.
[50]
Section
35(1)(
xli
)
of
the Medicines Act.
[51]
Above n 15.
[52]
In considering whether regulation 18 constitutes an infringement of
section 22, I intend to consider regulation 18 as if sub-regulations
18(5)(a), (b), (c), (d) and (e) do not form part of regulation 18.
The reason for this approach will become clear from
conclusions
reached later in this judgment.
[53]
Kommers
The
Constitutional Jurisprudence of the Federal Republic of Germany
2 ed (Duke University Press, Durham and London 1997) translating the
German Court decision in the
Pharmacy
case [7 BVerfGE 377] at 274.
[54]
Id at 509.
[55]
Id at 275.
[56]
Id
[57]
As discussed in Currie
The
Constitution of the Federal Republic of Germany
2
ed (The University of Chicago Press, Chicago and London 1994) at 301
footnote 186.
[58]
As discussed in Michalowski and Woods
German
Constitutional Law: The Protection of Civil Liberties
(Ashgate and Dartmouth, Great Britain 1999) at 305.
[59]
Section 26 of the Interim Constitution provided:
“
(1)
Every person shall have the right freely to engage in economic
activity and to pursue a livelihood anywhere in the national
territory.
(2)
Subsection (1) shall not preclude measures designed to promote the
protection or the improvement of the quality of life, economic
growth, human development, social justice, basic conditions of
employment, fair labour practices or equal opportunity for all,
provided such measures are justifiable in an open and democratic
society based on freedom and equality.”
[60]
New
National Party of South Africa v Government of the Republic of South
Africa and
Others
[1999] ZACC 5
;
1999 (3) SA 191
(CC);
1999 (5) BCLR 489
(CC) at para 19.
[61]
S v
Makwanyane and Another
[1995] ZACC 3
;
1995
(3) SA 391
(CC);
1995 (6) BCLR 665
(CC) at para 156.
[62]
Prinsloo
v Van der Linde and Another
[1997] ZACC 5
;
1997 (3) SA 1012
(CC);
1997 (6) BCLR 759
(CC) at para 25.
[63]
Above n 60.
[64]
Id at para 19.
[65]
Above n 40 at para 83.
[66]
Id at para 85.
[67]
Id
[68]
Id at paras 85 -6.
[69]
Above n 60 at para 20; Above n 40 at para 83;
President
of the Republic of South Africa and Another v Hugo
[1997] ZACC 4
;
1997 (4) SA 1
(CC);
1997 (6) BCLR 708
(CC) at para 13;
President
of the Republic of South Africa and Others v South African Rugby
Football Union and Others
2000 (1) SA 1
(CC);
1999 (10) BCLR 1059
(CC) at para 148.
[70]
Section 7(3) of the Constitution provides:
“
The
rights in the Bill of Rights are subject to the limitations
contained or referred to in section 36, or elsewhere in the Bill.”
[71]
Above n 40 at para 90.
[72]
1998 (10) BCLR 1307
(E).
[73]
Id at 1323B.
[74]
Id at 1322H-1323B. It is not necessary to consider whether a
monopoly affects choice or not. I refrain from expressing
any
view on this issue.
[75]
Id at 1322E-F.
[76]
Above n 60 at para 24.
[77]
1997 (4) SA 1176
(CC);
1997 (10) BCLR 1348
(CC).
[78]
Section 26 of the Interim Constitution provided:
“
(1) Every person
shall have the right freely to engage in economic activity and to
pursue a livelihood anywhere in the national
territory.
(2)
Subsection (1) shall not preclude measures designed to promote the
protection or the improvement of the quality of life, economic
growth, human development, social justice, basic conditions of
employment, fair labour practices or equal opportunity for all,
provided such measures are justifiable in an open and democratic
society based on freedom and equality.”
[79]
Above n 77 at para 44.
[80]
Id at para 45.
[81]
Id at para 30.
[82]
Id at paras 44-5.
[83]
Above para 64.
[84]
Above n 53 at 275.
[85]
Id
[86]
Id at 275 to 276.
[87]
Id at 278.
[88]
Id at 276.
[89]
Id
[90]
Id
[91]
Id
[92]
Id
[93]
Id
[94]
The requirement of proportionality became apparent in a later case,
the
Chocolate
Candy
case. The case concerned section 14(2) of the Chocolate
Products Act of June 30, 1975 which regulates the practice of an
occupation. The question for decision was whether the impugned
provision fell within the purview of article 12(1) of the
Basic
Law. The court framed the question for decision as “whether
a regulation [which limits] the practice of a trade
is consistent
with the principle of proportionality . . .” In
determining this question, however, the court noted
that it had to
“take into account the discretion which the legislature has –
within the framework of its authority
– in the sphere of
commercial activity.” And in this regard, it noted that
“[t]he Basic Law grants the
legislature wide latitude in
setting economic policy and devising the means necessary to
implement it.” It found
on the facts that the
legislature had exceeded the proper bounds of its discretion because
there were less restrictive means
that could have easily achieved
the purpose of the statute. See discussion by Kommers, above n
53 at 279-80.
[95]
De Waal, Currie and Erasmus contend for a construction of section 22
that permits the legislature to regulate both choice and
practice.
They contend that choice and practice of an occupation are not
conceptually distinct, but rather “constitute
poles of a
continuum”. They argue that the regulation of practice
“will almost always” impact on choice
of a profession.
Both choice and practice are afforded protection from arbitrary
regulation by section 22. “By
the same token, this would
mean that both choice and practice are subject to the internal
qualification. It is implausible
to argue that the internal
qualification will not apply when regulation of the practice of an
occupation also impacts on access
to or choice of that occupation.
This will almost always be the case. The better interpretation
is therefore that
the internal qualification in principle applies to
restrictions on entry, choice and practice of an occupation.”
(
The
Bill of Rights Handbook
4 ed (Juta & Co Ltd 2001) at 385-6)
By
contrast Chaskalson et al, relying on the approach of the German
Constitutional Court in the
Pharmacy
case suggest the right
to choose a profession must be given greater protection than the
right to practice a profession.
However, based on our
Constitution, they argue that the limitation on choice “should
be examined rather as a limitation
problem in terms of s 36, as
opposed to a question about the regulation of practice, which falls
for determination under s 22.”
(
Constitutional Law of
South Africa
(Juta & Co Ltd 1999) at para 29.5 (a))
[96]
See paras 106-23.
[97]
Dawood
above
n 28 at para 47. See also
Hugo
above n 69 at para 102;
Hyundai
above
n 31 at para 24.
[98]
R v
Pretoria Timber Co (Pty) Ltd & Another
1950 (3) SA (A) 163 at 176G.
[99]
R v
Jopp and Another
1949 (4) SA 11
(N) at 13-4.
[100]
R. v
N.S. Pharmaceutical Society
10 C.R.R. (2d) 34 at 58.
[101]
Above
n 99 at 13.
[102]
See n 31.
[103]
Above n 99 at 14.
[104]
Sub-regulation 18(5)(a).
[105]
Sub-regulation 18(5)(c).
[106]
Sub-regulation 18(5)(d).
[107]
Sub-regulation 18(5)(e).
[108]
Section 22D of Related Substances Act 101 of 1965 provides that:
“
A licence issued
under section 22C shall be valid for the prescribed period but may
be renewed on application in the prescribed
manner and before the
prescribed time or such later time as the Director-General or the
council, as the case may be, may allow
and on payment of the
prescribed fee.”
[109]
Rail
Commuters Action Group and Others v Transnet Ltd t/a Metrorail and
Others
[2004] ZACC 20
;
2005 (4) BCLR 301
(CC) at para 47.
[110]
Id at para 43;
Zondi
above n 31 at para 22;
Bel
Porto School Governing Body and Others v Premier, Western Cape, and
Another
[2002] ZACC 2
;
2002 (3) SA 265
(CC);
2002 (9) BCLR 891
(CC) at para 119;
Prince
v President, Cape Law Society and Others
[2000] ZACC 28
;
2001 (2) SA 388
(CC);
2001 (2) BCLR 133
(CC) at paras 21;
Staatspresident
en ʼn
Ander v
Lefuo
[1990] ZASCA 6
;
1990
(2) SA 679
(A) at 691C-J;
Deintje
v
Gratus & Gratus
1929 AD 1
at 6-7; and
Shein
v Excess Insurance Company, Ltd
1912 AD 418
at 428-9.
[111]
Above n 109 at para 43.
[112]
1997 (2) SA 898 (CC); 1997 (6) BCLR 692 (CC).
[113]
Id at para 30.