The Affordable Medicines Trust and Others v The Minister of Health of the Republic of South Africa and Others

This case concerned a constitutional challenge to a licensing scheme for medical practitioners who wish to dispense medicines. Prior to 2004, medical practitioners could dispense medicines by simply informing the Health Professions Council. The new scheme, introduced through amendments to the Medicines Act (sections 22C-22H) and Health Professions Act (section 52), required medical practitioners to obtain a licence from the Director-General of Health to dispense medicines. The licence could only be issued on prescribed conditions, required supplementary training in good dispensing practice, and was linked to specific premises. Regulation 18 of the Medicines and Related Substances Act Regulations detailed application requirements and factors the Director-General must consider, including the existence of other licensed health facilities in the vicinity, geographic area, estimated health care users, and demographic considerations. The applicants (the Affordable Medicines Trust, the National Convention on Dispensing, and Dr Mabasa) challenged: (1) the phrase "on the prescribed conditions" in subsection 22C(1)(a) as vague and overbroad; (2) the linking of licences to specific premises as ultra vires and unconstitutional; (3) various provisions of regulation 18 as vague and creating a framework for refusing licences where pharmacies existed in the vicinity; and (4) regulation 20 on licence renewal periods. The High Court dismissed the challenge. The respondents stated the scheme was designed to address bad dispensing practices, including allowing lay staff to dispense, dispensing expired medicines, improper storage, and conflicts of interest created by pharmaceutical company incentives.

• Whether the phrase 'on the prescribed conditions' in subsection 22C(1)(a) is impermissibly vague and confers arbitrary power on the Director-General
• Whether the Minister exceeded her powers in making regulations that link a licence to dispense medicines to specific premises
• Whether the linking of licences to premises falls outside the scope of permissible regulation under section 22 of the Constitution
• Whether the linking of licences to premises infringes the rights to dignity, freedom of movement, and property
• Whether sub-regulation 18(5) is void for vagueness
• Whether sub-regulation 18(5)(a), (c), (d) and (e) are ultra vires the empowering statute and unconstitutional in creating a framework to deny licences where pharmacies exist in the vicinity
• What is the standard for determining permissible regulation of the practice of a profession under section 22
• Whether regulation 20 on licence renewal is arbitrary

Application for leave to appeal GRANTED. Appeal UPHELD IN PART. Sub-regulation 18(5)(a), (c), (d) and (e) declared inconsistent with the Constitution and invalid. All other challenges dismissed. No order for costs in this Court or the High Court. The High Court order is set aside and replaced with the above.

1. Section 22 of the Constitution protects both the choice of a profession and the right to practice the chosen profession as a unitary right. Regulation of practice is permitted, but regulation that objectively viewed would negatively impact choice limits section 22 and must satisfy section 36(1). 2. The standard for permissible regulation of the practice of a profession under section 22 is: (a) the regulation must be rationally related to a legitimate government purpose; and (b) it must not infringe any rights in the Bill of Rights (or if it does, must satisfy section 36(1)). 3. The doctrine of legality requires that all public power, including delegated legislative power, must be exercised within the scope of the empowering statute. Acting ultra vires is unconstitutional. 4. Where Parliament delegates power to prescribe conditions for licensing, the discretion must be constrained by the statute's objectives, purposes, and context. Discretion cannot be arbitrary - it must be exercised rationally having regard to relevant considerations. 5. Regulations linking dispensing licences to specific premises from which medicines are dispensed are rationally connected to ensuring access to safe medicines because: (a) storage conditions affect medicine safety and efficacy; (b) premises must be suitable for good dispensing practice; and (c) linking to known premises facilitates inspection and enforcement. 6. Regulations purporting to deny licences where pharmacies exist in the vicinity, for the purpose of protecting pharmacies from competition, exceed the powers granted by the Medicines Act and are ultra vires and unconstitutional where the empowering statute's purpose is public health and safety, not market protection.

1. The Court noted the "regrettable practice" of tendering evidence on appeal only days before hearing, which must be discouraged. Further evidence will only be admitted in exceptional circumstances where it is weighty, material, credible, and there is reasonable explanation for late filing. 2. The Court commented that it could not conceive of anything that would harm the dignity of the medical profession in requiring compliance with good dispensing practice - if anything, this should enhance their dignity in the eyes of the public they serve. 3. The Court noted that the response by the respondents regarding the National Drug Policy "leaves a good deal to be desired" and that the failure to explain the contradiction between their denial of a policy to refuse licences near pharmacies and the clear policy stated in the NDP was "inexplicable except on the basis that the deponent...was either not entirely candid with the Court" or the policy had been abandoned without explanation. 4. On the German Constitutional Court's "gradation theory" under Article 12(1) of the Basic Law: While acknowledging similarities to section 22 and the attractiveness of the German approach, the Court emphasized that "it is our Constitution that is being construed" and must be interpreted according to South African constitutional scheme and jurisprudence. 5. The Court noted that under the apartheid regime, job reservation, pass laws, and exclusion of women from occupations made freedom to choose one's vocation particularly important to constitutionally protect, but the significance goes beyond correcting past injustices - vocational freedom is intrinsic to human dignity. 6. On reasonableness vs rationality: The Court explained why rationality rather than reasonableness/proportionality is appropriate for reviewing regulation of practice under section 22, distinguishing this from the section 36(1) inquiry where proportionality is central. 7. The Court observed that two separate licences (one for the practitioner, one for premises) as proposed by applicants would not solve the perceived problem, since a practitioner with multiple premises would still need those premises reflected in or added to the licence.

This case is significant for: 1. **Clarifying section 22**: It establishes that section 22 protects both the choice of profession and the practice of profession as a unitary right, but they are subject to different levels of regulation. 2. **Standard for regulating practice**: Adopts rationality as the test for regulations that affect practice but do not, objectively viewed, negatively impact choice. Regulations of choice must meet the more stringent section 36(1) test. 3. **Principle of legality and vagueness**: Affirms that discretionary powers must be constrained by statutory purpose and context. Laws must indicate with reasonable certainty what is required, though absolute certainty is not demanded. 4. **Ultra vires in constitutional context**: Explains that acting ultra vires an empowering statute is a breach of the principle of legality and therefore unconstitutional. 5. **Separation of powers**: Respects legislative latitude to regulate professions while ensuring regulations are rationally connected to legitimate purposes and do not serve impermissible objectives like protecting existing market participants from competition. 6. **Health regulation**: Upholds comprehensive regulation of medicine dispensing (including premises requirements) as rationally connected to public health and safety. 7. **Costs in constitutional litigation**: Reaffirms the general rule against costs orders in constitutional litigation but shows flexibility based on circumstances.