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

The applicants, consisting of professional associations and a medical practitioner, challenged aspects of a statutory licensing scheme introduced under the Medicines and Related Substances Act 101 of 1965 and related Regulations. The scheme required medical practitioners and other health care providers to obtain a licence from the Director-General of Health to dispense medicines, subject to prescribed conditions and linked to specific premises. The applicants argued that certain provisions empowering the Director-General to impose conditions, linking licences to premises, and prescribing factors to be considered in licence applications were vague, overbroad, unauthorised by the enabling legislation, and inconsistent with the principle of legality and section 22 of the Constitution. The High Court dismissed the challenge, and the applicants sought leave to appeal directly to the Constitutional Court.

Leave to appeal was dismissed, and the constitutional challenge to section 22C(1)(a) of the Medicines Act and the impugned regulations failed. The High Court’s order dismissing the application, including the costs order, was effectively upheld.

This case is a leading authority on the principle of legality and permissible delegation of legislative power in South African constitutional law. It confirms that Parliament may confer regulatory discretion on the executive, provided the discretion is guided by statutory purpose and context. The judgment also clarifies the scope of section 22 of the Constitution, confirming that professional practices may be regulated in the public interest, particularly in the health sector.