The Affordable Medicines Trust, et al. v. Minister of Health and Director-General of Health

Case CCT 27/04
Download Judgment: English

T, an organisation campaigning on behalf of those seeking affordable medicines in addition to promoting the rights of medical practitioners to dispense medicines to the public, together with N, an association of dispensing providers and M, a medical practitioner authorised to dispense medicines, challenged certain aspects of a licensing system governed by the Medicines and Related Substances Act 1965 (‘the Act’) under which health care providers could not dispense medicines unless they were issued with a licence subject to conditions imposed  by the Director-General of the Department of Health (‘the Director-General’), in particular relating to the safety of consumption. T and the others challenged the powers of the Director General to prescribe conditions upon which licences could be issued, the linking or “coupling” of a license to dispense medicines to specified premises and the factors to which the Director-General was required to have regard when considering an application. In so doing they argued that (a) the Act gave the Minister of Health (‘the Minister’) uncircumscribed and arbitrary powers to make regulations; (b) the coupling of the licence and premises was outside the Minister’s powers; (c) this coupling infringed s 22[1] of the Constitution which protected the right to choose a profession; and (d) that sub-regulations 18(5),(6) and (7) issued under the Act required the Director-General to make decisions on facts that were not objectively ascertainable.  They also claimed the scheme breached the rights to freedom of movement and property as guaranteed by ss 21[2] and 25[3] of the Constitution respectively.

The High Court found that there was nothing arbitrary or capricious in the regulations, that they were made within the Minister’s powers and in pursuance of the legitimate purposes of increasing safe access to medicines and that they did not therefore infringe s 22 of the Constitution nor any of the other constitutional rights asserted by the applicants.  T & the others applied for leave to appeal directly to the Constitutional Court from the judgment of the High Court.


[Adapted from INTERIGHTS summary, with permission]

In granting the appeal, in part, it was held that:

(1) There must be some constraints on the exercise of broad, discretionary powers delegated by Parliament, so that those who are effected 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.  (Darwood and Another v Minister of Home Affairs and Others [2000] (3) SA 396 (CC); [2000] (8) BCLR 837 (CC) applied).

(2) However, this is not the case here. Whilst the Act does confer wide discretion on the Director-General this is not unlimited. They are constrained to the extent that they must only be exercised to impose conditions which fulfil the purpose of increasing access to medicines which are safe for human consumption.

(3) In this respect, the coupling of the licence and premises is within the Minister's powers as the premises need to be suitable for the storage of medicines. Dispensing from specified premises that are regulated facilitates inspection in order to ensure that good practice is observed.

(4) Section 22 implicitly consists of two components: the right to choose and the right to practise the chosen profession (Pharmacy case [7 BVerFGE 377] applied)[4]. This provision has to be understood as both repudiating past exclusionary practices and affirming the entitlements appropriate for a new and open democratic society. In the light of the history of job reservation, restrictions imposed by the pass laws and exclusion of women from many occupations, it is understandable why this aspect of economic activity was assigned constitutional protection. What is at stake is more than one’s right to earn a living, important thought 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. The relationship between work and the human personality shapes and completes the individual over a lifetime of devoted activity; it is the foundation of a person’s existence.

(5) However, regulation of vocational activity for the protection of both the persons involved in it and of the community at large, provided it is in the public interest and not arbitrary or capricious, is to be both expected and welcomed. In this case the regulation of the practise of the chosen profession is permitted provided, inter alia, it does not limit the choice of profession.  In these circumstances, since the licence does not need to be issued to the owner of the premises, the linkage does not limit the right to choose the profession but meraly regulate the specific circumstances in which medical practitioners may, if they choose, continue to compound and dispense medicines.

(6) Moreover, regulating the practice of the profession is not prohibited by the Constitution provided it is firstly, rationally connected to the achievement of a legitimate government purpose and secondly, does not infringe any provision of the Bill of Rights (New National Party of South Africa v Government of the Republic of South Africa and Others [1999] (3) SA 191; [1999] (5) BCLR 489 applied).  There is no need for the measures to be reasonable or proportionate Van Rensburg v S. African Post Office Ltd [1988] 10 BCLR 1307(E) disapproved). The guiding principle is that the legislature should have the widest possible powers within the limits of the Constitution (S v Lawrence, S v Negal, S v Solberg [1997] (4) SA 1176 applied).

(7) The coupling of the licence to premises is rationally connected to the government objective of increasing safe access to medicines and therefore permitted by Article 22. Since the regulation does not impact on choice of profession it is not necessary to consider the concept of proportionality.

(8) The regulation does not infringe the right to movement or the right to property or to dignity. There is nothing in the regulations to suggest that medical practitioners will be prevented from practising their profession from wherever they choose. Nor is there anything that would harm those medical practitioners who wish to dispense medicines as part of their practice by making them comply with good dispensing practice. If anything that would enhance their dignity in the eyes of the public.

(9) Nor are the impugned provisions void for vagueness. Applying the normal rules of construction, including those required by constitutional adjudication (R v N.S. Pharmaceutical Society 10 C.R. R. (2d) adopted) there is a reasonable level of certainty based on the factors to be taken into account by the Director General in making his decision (number of health care users; geographic area to be served; existence of other facilities in the vicinity),  so that those bound by the regulations can control their conduct accordingly (R v Jopp and Another [1949](4)SA11(n) applied). The doctrine of vagueness did not require absolute certainty of laws. It must also recognise the role of government in furthering legitimate social and economic objectives.

(10) However, the policy of refusing a licence where there are other pharmacies in the vicinity, in so far as it is designed to protect pharmacies from competition from medical practitioners and nurses, is not within the purpose of the Act and is therefore ultra vires.

End Notes

[1] Section 22 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.’

[2] Section 21 provides: ‘(1) Everyone has the right to freedom of movement. (2) Everyone has the right to leave the Republic. (3) Every citizen has the right to enter, to remain in and to reside anywhere in, the Republic. (4) Every citizen has the right to a passport.’

[3] Section 25 provides inter alia: ‘(1) No one may be deprived of property except in terms of law of general application, and no law may permit arbitrary deprivation of property…’

[4] Section 22 is almost identical to Article 12(1) of the German Basic Law which 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 profession may be regulated by or pursuant to a law.’



[Adapted from INTERIGHTS summary, with permission]

Lawyers: For the Appellants: 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).   Judge: Ngcobo J.