The Affordable Medicines Trust, et al v The Minister of Health of the Republic of
South Africa, et al CCT 27/04
POST-HEARING MEDIA SUMMARY
The following explanatory note is provided to assist the media in reporting this case
and is not binding on the Constitutional Court or any member of the Court.
On Friday, 11 March 2005, the Constitutional Court handed down judgment in the
matter of Affordable Medicines Trust and Others v The Minister of Health and
Others.
This case follows an 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 Health. The scheme also regulates the premises
from which medicines are dispensed. The challenge was directed at the powers of the
Director-General to prescribe the conditions upon which licences may issued, the
linking of a licence to prescribe medicines to particular premises and the factors
which the Director-General is required to have regard when considering an
application for a licence to dispense medicines.
The challenge was brought by the Affordable Medicines Trust, the National
Convention on Dispensing and Doctor Mphata Norman Mabasa, all of whom
represented the interests of medical practitioners.
They challenged the constitutional validity of certain provisions of the Medicines and
Related Substances Act, and regulations made under that Act. In the first place they
contended that the provisions of the Act which conferred the power on the DirectorGeneral to determine the conditions upon which a licence may be issued was too
broad and gave the Director-General un-circumscribed arbitrary legislative powers.
In the second place they contended that the linking of the licence to compound and
dispense medicines to specific premises was not authorised by the Medicines and
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Related Substances Act and that therefore the Minister exceeded her powers when
making regulations that require a licence to dispense and compound medicines to be
linked to specific premises. In the alternative, they contended that the requirement of
linking a licence to specific premises falls outside the authority to regulate practice of
the medical profession.
Finally they attacked the regulations made under the
Medicines and Related Substances Act on the ground that they are vague and thus
authorise the Director-General to make decisions that are arbitrary.
The Minister of Health and the Director-General, who opposed the application,
contended that the linking of the licence to dispense and compound medicines is
essential to the government purpose to increase access to medicines that are safe for
consumption by the public. They submitted that under the old legislative framework,
medical practitioners were not adequately regulated and that there were no standards
to ensure that registered health practitioners complied with good dispensing practices.
This, according to the Minister of Health and the Director-General of Health resulted
in unacceptable practices such as pharmaceutical companies giving incentives to
medical practitioners, medical practitioners selling on samples that they had received
free from pharmaceutical companies and dispensing of medicines that are either old or
not appropriately labelled.
The government denied that it had a policy of denying a licence to dispense and
compound medicines to medical practitioners where there are pharmacies in the
neighbourhood where a medical practitioner intends to compound and dispense
medicines from.
In a unanimous judgment, Justice Ngcobo found that although section 22C(1)(a)
conferred wide discretionary powers upon the Director-General to determine
conditions upon which a licence may be issued, the statutory framework provides
sufficient guidance for the exercise of those powers. He held that the conditions that
may be imposed are only those that are in the furtherance of the objective to increase
access to medicines that are safe for consumption by the public.
He therefore
dismissed the challenge to section 22C(1)(a) of the Medicines and Related Substances
Act.
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Justice Ngcobo also found that in making the regulations that link the licence to
dispense and compound medicines to particular premises, the Minister did not exceed
her powers under the Medicines and Related Substances Act. He found that the
empowering statute confers wide powers on the Minister to make regulations in order
to further the objective of the Act.
These powers include the power to make
regulations with regard to any matter to ensure the safety, quality and efficacy of
medicines. He found that the requirement that dispensing medical practitioners must
dispense medicines through particular premises facilitates regular inspection of those
premises for compliance with good dispensing practices. He also found that if the
public is to have access to medicines that are safe, the activity of dispensing
medicines cannot be reasonably be de-linked from the premises from which such
dispensing takes place.
He also held that the requirement that medicines must be dispensed from particular
premises does not prevent the licence to dispense medicines from being issued to
medical practitioners who practice as locum tenens. Such medical practitioners are
entitled to be issued with a licence subject to the condition that they may only
dispense medicines from premises in respect of which a licence has been issued. He
also found that the linking of a licence to dispense medicines to particular premises
does not violate any constitutional rights. He accordingly held that the Minister did
not exceed her powers when making regulations that require a licence to dispense
medicines to be issued in respect of particular premises.
Accordingly, Justice Ngcobo held that section 22C(1)(a) of the Medicines and Related
Substances Act and regulations 18(3)(b), (f), (g), (h) and (i); 18(5)(b) and (f); 18(6);
18(7) and regulation 20 of the Regulations, are constitutional.
However, Justice Ngcobo found that the purpose of the provisions of the regulations
that set out the factors to which the Director-General must have regard in considering
an application for a licence was to protect pharmacies against competition from
medical practitioners and nurses. He held that these provisions must be construed in
the light of the National Drugs Policy of the Department of Health which provides
among other things that medical practitioners and nurses will not be permitted to
dispense medicines where there are pharmacies in the neighbourhood. He found that
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this purpose is not authorised by the Medicines and Related Substances Act and that
the Minister was not authorised by the statute to develop such a policy through the
regulations. He accordingly held that the provisions of regulation 18(5)(a), (c), (d),
(e) were invalid because they went beyond the powers conferred upon the Minister by
the statute.
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