Minister of Health and Another v New Clicks South Africa (Pty) Ltd and Others

Following amendments to the Medicines and Related Substances Act 101 of 1965 aimed at making medicines more affordable, the Minister of Health, acting on the recommendation of the Pricing Committee, promulgated regulations establishing a medicine pricing system, including a single exit price (SEP) and regulated dispensing fees. Pharmacy groups, including New Clicks and the Pharmaceutical Society of South Africa, challenged the validity of these regulations in the Cape High Court, alleging procedural unfairness, unlawful delegation of powers, vagueness, and that the dispensing fee was not ‘appropriate’ as required by the Act. The High Court largely dismissed the challenges. The Supreme Court of Appeal (SCA) subsequently held the regulations invalid. The Minister and the Pricing Committee appealed to the Constitutional Court.

The appeal succeeded in part. The SCA order setting aside the regulations in their entirety was overturned. The pricing regulations were largely upheld, subject to specific declarations of invalidity, severance, and reading‑in. Regulations fixing the pharmacists’ dispensing fee were declared invalid, while the remainder of the pricing scheme remained in force.

This is a leading Constitutional Court authority on administrative law, the applicability of PAJA to regulation‑making, and the constitutional control of subordinate legislation. It confirmed the lawfulness of the state’s medicine pricing regime, reinforced transparency and accountability in regulatory processes, and clarified remedies such as severance and reading‑in in constitutional litigation. The case is central to South African health‑care regulation jurisprudence.