The 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 purporting to bring into operation the South African Medicines and Medical Devices Regulatory Authority Act 132 of 1998 (the Act), which repealed the Medicines and Related Substances Control Act 101 of 1965. However, when the President brought the Act into force, the necessary regulatory infrastructure was not in place - specifically, schedules required to give effect to the Act's prohibitions on the sale, possession and manufacture of medicinal substances had not been made by the Minister of Health. The Act regulates medicinal substances by prohibiting their sale, possession or manufacture except in accordance with prescribed conditions set out in schedules. Without these schedules, the criminal prohibitions in the Act were meaningless and ineffective, and the entire regulatory regime for controlling medicines collapsed. The President and other applicants, realizing this fundamental error, urgently approached the Transvaal High Court seeking to have the Proclamation set aside. The High Court (Fabricius AJ) dismissed the application, finding the President had acted within his powers and in good faith. On appeal, the Full Bench of the Transvaal High Court reversed this decision and declared Proclamation R49 null and void. The matter was then referred to the Constitutional Court for confirmation under section 172(2)(a) of the Constitution.

• Whether a court order declaring conduct of the President invalid is subject to confirmation by the Constitutional Court under section 172(2)(a) of the Constitution
• Whether judicial review of executive action is governed solely by common law or by the Constitution
• Whether the decision to bring an Act into force constitutes administrative action subject to section 24 of the interim Constitution
• Whether the Constitution requires the exercise of public power by the executive to be objectively rational
• Whether a court has power to review and set aside a decision by the President to bring an Act of Parliament into force when that decision is irrational, even if made in good faith
• Whether the doctrine of legality is a constitutional principle flowing from the rule of law
• The scope of section 172(2)(a) of the Constitution concerning orders about 'any conduct of the President'

The order of the Full Bench of the Transvaal High Court declaring Proclamation R49 of 1999 null and void and of no force or effect was confirmed by the Constitutional Court.

The binding legal principles established are: (1) The doctrine of legality, an incident of the rule of law enshrined in section 1(c) of the Constitution, requires that all exercises of public power must be lawful and subject to constitutional control. (2) Questions concerning the lawfulness of the exercise of public power are constitutional matters within the jurisdiction of the Constitutional Court. (3) Common law principles governing judicial review of administrative and executive action have been subsumed under the Constitution; there is only one system of law, with the Constitution as supreme law. (4) The Constitution requires that the exercise of public power by the executive and other functionaries be objectively rational - this is a minimum threshold requirement applicable to all public power. (5) A decision is objectively rational if it is rationally related to the purpose for which the power was given. Whether a decision is rational is determined objectively, not by reference to the subjective belief or good faith of the decision-maker. (6) A decision by the President to bring an Act into force that is objectively irrational is inconsistent with the Constitution and therefore unlawful and subject to being set aside by a court. (7) Good faith and absence of mala fides do not immunize executive action from constitutional review for rationality. (8) Section 172(2)(a) applies to any conduct of the President that raises constitutional issues, and must be interpreted widely to ensure Constitutional Court control over declarations of invalidity concerning the highest state organs.

Chaskalson P made several significant obiter observations: (1) He expressed the view that the President's decision to bring the Act into force, while subject to constitutional review, did not constitute "administrative action" within the meaning of section 24 of the interim Constitution (as preserved by the 1996 Constitution) because it was closer to the legislative than the administrative process. (2) He suggested that there might be cases where a court would decline to intervene in matters properly to be dealt with by the legislature, but stated this was not such a case. (3) He noted that there may be cases where the making of regulations necessary to give effect to an Act could be so closely related in time and circumstance to the proclamation bringing it into force that they could be treated as a single process, but this was not such a case. (4) He observed that under section 173, the Constitutional Court has power to develop the common law in constitutional matters within its jurisdiction. (5) He noted that the power to bring legislation into force imposes a duty to do so "as soon as [the President] might properly judge it to be appropriate" having regard to all relevant factors, though these factors do not become jurisdictional facts. (6) He acknowledged the reluctance of courts in other jurisdictions to review decisions closely related to the legislative process, discussing cases from Canada, the UK, and India. (7) He noted that prejudice arising from declarations of invalidity could be addressed through the court's powers under section 172(1) to suspend orders, limit retrospective effect, or make just and equitable orders. (8) He confirmed that the separation of powers is a fundamental principle of the constitutional order but does not insulate executive decisions from review for legality.

This landmark judgment is of fundamental importance in South African constitutional and administrative law for several reasons: (1) It established that the doctrine of legality, flowing from the rule of law, is a constitutional principle that subjects all exercises of public power to constitutional review. (2) It clarified that common law principles of judicial review have been constitutionalized - there are not two parallel systems (common law and constitutional) for reviewing public power. (3) It established the principle of objective rationality as a minimum constitutional threshold for the exercise of all public power by the executive and other functionaries. (4) It confirmed that even decisions made by the President in good faith can be reviewed and set aside if objectively irrational. (5) It addressed the difficult question of justiciability of executive decisions closely related to the legislative process, holding that such decisions, while not administrative action, remain subject to constitutional review for legality. (6) It gave substantive content to the rule of law as a foundational constitutional value. (7) It clarified the scope and purpose of section 172(2)(a) concerning confirmation of orders declaring presidential conduct invalid. The case represents a complete break from the pre-constitutional doctrine limiting judicial intervention where officials acted in good faith (the Shidiack principle), establishing instead that objective rationality, not subjective good faith, is the constitutional standard. It is a cornerstone case for understanding the constitutional control of executive power in the post-1994 democratic order.