Pharmaceutical Manufacturers Association of South Africa and Another: In re Ex Parte President of the Republic of South Africa and Others (CCT31/99) [2000] ZACC 1; 2000 (2) SA 674; 2000 (3) BCLR 241 (25 February 2000)

Pharmaceutical Manufacturers Association of South Africa and Another: In re Ex Parte President of the Republic of South Africa and Others (CCT31/99) [2000] ZACC 1; 2000 (2) SA 674; 2000 (3) BCLR 241 (25 February 2000)

The Constitutional Court held that the President's decision to bring the South African Medicines and Medical Devices Regulatory Authority Act, 132 of 1998, into force was not rationally related to the purpose for which the power was conferred. The necessary regulatory infrastructure, including schedules and...

Source-derived case information.

Citation
[2000] ZACC 1
Parties
Appellant: Pharmaceutical Manufacturers Association of South Africa (Association Incorporated in terms of Section 21); Appellant: Crop Protection and Animal Health Association (Association Incorporated in terms of Section 21); Applicant: President of the Republic of South Africa; Applicant: Minister of Health; Applicant: Registrar of Medicines; Applicant: Chairperson, Medicines Control Council; Applicant: Minister of Agriculture; Applicant: Registrar of Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies
Court
Constitutional Court
Jurisdiction
South Africa
Case Number
CCT31/99
Procedural Posture
Constitutional Review / Confirmation of High Court Order of Constitutional Invalidity
Outcome
Order of constitutional invalidity confirmed. The President's Proclamation bringing the Act into force is declared invalid and of no force or effect.
Judges
Chaskalson P, Langa DP, Ackermann J, Madala J, Mokgoro J, Ngcobo J, O'Regan J, Sachs J, Yacoob J, Cameron AJ
Legal Topics
Doctrine of Legality, Ultra Vires, Presidential Conduct, Rationality Review, Judicial Review of Executive Action
Constitutional Law Administrative Law Doctrine of Legality Ultra Vires Presidential Conduct Rationality Review Judicial Review of Executive Action

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Summary, issues, holding and outcome

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Parties

Pharmaceutical Manufacturers Association of South Africa (Association Incorporated in terms of Section 21)

Appellant

Crop Protection and Animal Health Association (Association Incorporated in terms of Section 21)

Appellant

President of the Republic of South Africa

Applicant

Minister of Health

Applicant

Registrar of Medicines

Applicant

Chairperson, Medicines Control Council

Applicant

Minister of Agriculture

Applicant

Registrar of Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies

Applicant

Procedural Posture

Constitutional Review / Confirmation of High Court Order of Constitutional Invalidity

  1. 1 Does the President's decision to bring the South African Medicines and Medical Devices Regulatory Authority Act, 132 of 1998, into force constitute conduct subject to constitutional review?
  2. 2 Was the President's decision to bring the Act into force rationally related to the purpose for which the power was conferred?
  3. 3 Is an order declaring the President's conduct invalid subject to confirmation by the Constitutional Court under section 172(2)(a) of the Constitution?

Ratio Decidendi

The Constitutional Court held that the President's decision to bring the South African Medicines and Medical Devices Regulatory Authority Act, 132 of 1998, into force was not rationally related to the purpose for which the power was conferred. The necessary regulatory infrastructure, including schedules and regulations, was not in place, rendering the regulatory regime unworkable and exposing the public to significant risks. The President acted in good faith but under a mistaken belief, and the decision was objectively irrational. The Court confirmed that all exercises of public power must comply with the Constitution and the doctrine of legality, and that irrational decisions are subject...

Court Disposition

Order of constitutional invalidity confirmed. The President's Proclamation bringing the Act into force is declared invalid and of no force or effect.

Orders

  • The order of the Full Bench declaring Proclamation R49 of 1999 invalid and of no force or effect is confirmed.
  • The South African Medicines and Medical Devices Regulatory Authority Act, 132 of 1998, was not validly brought into force by the President's Proclamation.