Pharmaceutical Manufacturers Association of SA: In re Ex parte President of RSA

The President promulgated regulations under the Medicines Act without following proper procedures. The Pharmaceutical Manufacturers Association challenged the regulations, arguing they were unconstitutional and invalid because they exceeded the President's powers and were enacted without proper consultation.

• Legality
• Rule of law
• Executive power
• Constitutional supremacy
• Rationality review

The regulations were declared invalid. The court ordered that new regulations could only be promulgated after proper consultation and within the limits of the enabling legislation.

The principle of legality requires that all exercise of public power must be authorized by law and must be rational. This principle flows from the rule of law, which is a foundational value of the Constitution. Executive action that is not authorized by law or that is irrational is inconsistent with the Constitution and therefore invalid. The principle of legality applies even where specific constitutional rights are not directly implicated.

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This landmark case established the principle of legality as a ground of constitutional review separate from the Bill of Rights. It confirmed that all exercises of public power - including by the President - must be authorized by law and must be rational. The case is foundational to administrative law and constitutional litigation in South Africa.