Affordable Medicines Trust, et al. v. Minister of Health, et al.

In this constitutional challenge, the Applicants, including the Affordable Medicines Trust, applied for leave to appeal directly to the Constitutional Court an order of the High Court, which dismissed their constitutional challenge of certain aspects of a Government licensing scheme.

The licensing scheme provided that health care providers, such as medical practitioners and dentists, could not dispense medicines unless they had been issued a license to dispense such medicines by the Director-General of the Department of Health (Director-General). The scheme also regulated the premises from which medicines were to be dispensed.

The challenge was directed at the powers of the Director-General to prescribe conditions upon which licenses may be issued, the linking of a license to dispense medicines to particular premises, and the factors to which the Director-General was required to consider when considering an application for a license. It was further argued that the right of medical practitioners to choose their trade, occupation or profession freely was violated by the provisions of the licensing scheme.

The licensing scheme was enacted in section 22C of the Medicines and Related Substances Act 101 of 1965 (the Medicines Act), and the Regulations made under the Medicines Act and published in Government Notice R510 of 2003 in Government Gazette 24727 of 10 April 2003.

The Court considered a number of questions, three of which are addressed here. Firstly, it considered whether the provisions challenged, in particular section 22C(1)(a) of the Medicines Act and certain sub-regulations in Regulation 18(5), were vague and overbroad. In determining vagueness, the ultimate question according to the court was whether the law indicated with reasonable certainty to those bound by it what was required of them.

Section 22C(1)(a) of the Medicines Act made provision for the Director-General to issue licences to health care providers to compound and dispense medicines “on the prescribed conditions.” The Court held that the phrase “on the prescribed conditions” was not overbroad or vague. While the section conferred wide discretion on the Director-General, it was not uncontrolled or unlimited. Rather, the Director-General was obliged to have regard to all relevant considerations and disregard improper considerations. The “prescribed conditions” were to be rationally related to the purpose given for the discretionary powers and limited by the context in which the powers were to be exercised, such as the State purpose of increasing access to medicines that are safe for consumption.

The challenge to sub-regulations 18(5)(a), (c), (d) and (e), however, succeeded. The purpose of these sub-regulations was to protect pharmacies against competition from medical practitioners and nurses. The Court held that nothing in the Medicines Act granted the Minister authority to develop such a policy through regulations. Sub-regulations 18(5)(a), (c), (d) and (e) were thus held to be inconsistent with the Constitution and invalid.

Secondly, the Court considered the contention that the Minister exceeded her powers in establishing regulations that linked a licence to compound and dispense medicines to specific premises. The Court sought the answer to this question in the empowering provisions of the Medicines Act and held that this contention could not be sustained. The Court noted that section 35 of the Medicines Act conferred wide powers on the Minister to make regulations to the safety, quality and efficacy medicines. These included the power to:

“[R]egulate, control, restrict or prohibit the sale or use of any medicine; make regulations with regard to any matter to ensure the safety, quality and efficacy of medicines; regulate conditions under which medicines may be sold; make regulations with regard to any matter which shall or may be prescribed under the Medicines Act; and generally for the efficient carrying out of the objects and purposes of the Medicines Act.”

Thirdly, the Court considered whether the licensing scheme infringed upon the right of medical practitioners to choose a trade, occupation or profession freely. The Court noted the importance of the freedom to choose a vocation and declared that where a law regulating the practise of a profession, when viewed objectively, would negatively affect choice of profession and would potentially limit the right to choose a profession, then an enquiry must be conducted in terms of the limitation clause. The Court held that, on the facts before it, the regulation that required medical practitioners to dispense medicines from licensed premises did not purport to regulate entry into the medical profession or affect the choice of medical practitioners as to whether to remain in the profession and thus did not infringe upon the right. The Court further held that linking the licence to dispense to particular premises was rationally related to the Government objective to increase access to medicines that are safe for consumption by the public.

“[T]he 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.” Para. 38.

“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.” Para. 54.

“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.” Para. 59.

“[T]he 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.” Para. 72.