Pharmaceutical Manufacturers Association of South Africa and Another: In re Ex Parte President of the Republic of South Africa and Others

The President issued Proclamation R49 of 1999 bringing the South African Medicines and Medical Devices Regulatory Authority Act 132 of 1998 into force. At the time, essential schedules and regulations necessary for the Act’s operation had not been validly made. This meant that the repeal of key provisions of the Medicines and Related Substances Control Act 101 of 1965 occurred before a workable regulatory framework was in place. Concerned about the legal vacuum created, the President, relevant Ministers, officials, and industry associations applied to court to have the Proclamation (and a related Government Notice issuing schedules) declared invalid.

The Constitutional Court confirmed the Full Bench order declaring Proclamation R49 of 1999 invalid and of no force or effect.

This case is a foundational authority on the doctrine of legality in South African constitutional law. It establishes that all exercises of public power, including executive decisions taken under delegated statutory authority, are subject to constitutional review for legality. It clarified that review for ultra vires conduct is a constitutional matter and cemented the supremacy of the Constitution and rule of law over executive action.