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

• Jurisdiction: South Africa
• Judge: Chaskalson P, Langa DP, Ackermann J, Cameron AJ, Madala J, Mokgoro J, Ngcobo J, O'regan J, Sachs J, Yacoob J
• Judgment Date: 25 February 2000
• Docket Number: CCT 31/99
• Hearing Date: 11 November 1999
• Counsel: E Bertelsmann SC (with him J Moorcroft) for the first and second appellants (the seventh and eighth applicants). P Coppin for the first to sixth applicants.
• Court: Constitutional Court

Chaskalson P:

Introduction

[1] This case raises the question whether a Court has the power to review and set aside a decision by the President of this country to bring an Act of H Parliament into force. It began as an application to the Transvaal High Court by the President of the Republic of South Africa, the Minister of Health, the Minister of Agriculture, certain functionaries in the Departments of Health and Agriculture, the Pharmaceutical Manufacturers Association of South Africa and the Crop Protection and Animal Health Association for the setting aside of Proc I R49 of 1999 [1] and Government Notice R567 of 1999. [2] Proclamation R49 was issued by the President and purported to bring into operation the South African Medicines and J

Chaskalson P

Medical Devices Regulatory Authority Act 132 of 1998 (the A Act). [3] Government Notice R567 was issued by the Minister of Health and purported to provide Schedules to the Act in terms of s 31 read with s 54 of the Act.

[2] The circumstances in which the application was brought were as follows. Before the passing of the Act, the registration and control of medicine for human and animal use were governed by the Medicines and Related Substances Control Act 101 of 1965 (the 1965 Act). The registration and control of B agricultural substances and stock remedies were governed by the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act 36 of 1947 (the Stock C Remedies Act). The Act repealed all but a few provisions of the 1965 Act [4] and made material amendments to the Stock Remedies Act. [5]

[3] The Act provides that the manufacture, sale and possession of medicines for human and animal use be controlled through a system of scheduling substances and regulating the manufacture, the sale and possession of substances in the various D Schedules. The scheduling of medicines for human and animal use and the making of other regulations is an essential component of the regulatory system established by the Act. Schedules 1--9 identify regulated substances. Transitional provisions retain regulations made and Schedules determined in terms of the 1965 Act and the Stock Remedies Act, but Schedules 1--9 of the 1965 E Act are specifically repealed. [6] The Act makes provision for the determining of new Schedules and the making of regulations by the Minister. [7] It establishes the South African Medicines and Medical Devices Regulatory Authority (the Authority), [8] which is to be governed by a board F

Chaskalson P

appointed by the Minister in accordance with the provisions of the Act. [9] Pending the appointment of the board, the A Medicines Control Council established under the 1965 Act may perform the board's functions. [10]

[4] The Act was promulgated on 18 December 1998 and provides that it 'comes into operation on a date [to be] determined by the President'. [11] Proclamation R49, purporting to bring the B Act into force, was published in the Gazette on 30 April 1999. If the proclamation is valid, the repeal of the 1965 Act and Schedules 1--9 of that Act was effective from that date.

[5] In the founding affidavit filed on behalf of the President and the other C applicants in the High Court on 21 May 1999 by the acting Director-General of Health, Dr Pretorius, it was said:

'The scheduling status of medicines is a fundamental aspect of both the 1965 Act and Act 132 of 1998 and the regulations published in terms of these two Act(s), and must appear on all sales packs. It determines the manner in which the product may be marketed and sold.' D

According to the affidavit, the regulatory base necessary for the operation of the Act was not in place when Proc R49 was published because Schedules had not been made to replace the repealed Schedules of the 1965 Act and other essential regulations contemplated by the Act had not been made. E

[6] On 7 May 1999 the Minister issued Government Notice R567, which reads as follows:

'The Minister of Health has, in terms of s 31 read together with s 54 of the South African Medicines and Medical Devices Regulatory Authority Act 132 of F 1998 on the recommendation of the South African Medicines and Medical Devices Regulatory Authority made the Schedules in the Schedule.' [12]

It is alleged in the founding affidavit that regulations necessary to give effect to other provisions of the Act were not made. It is also alleged that the G Government Notice purporting to publish the Schedules was invalid.

[7] According to Dr Pretorius the effect of the absence of Schedules and regulations would be that

'. . . the entire regulatory structure relating to medicines . . . and the control of such medicines, has been rendered unworkable by the promulgation of Act 132 of 1998 in this manner'. H

This, he said, had not been appreciated by the Department of Health when it requested the President to bring the Act into operation. According to Dr Pretorius the request would not have been made, and the Act would not have been brought into force, but for this error. I

Chaskalson P

[8] Concerned to avoid the consequences of bringing the Act into force A prematurely, the applicants applied to the High Court as a matter of urgency for an order declaring that the proclamation and the Government Notice were invalid.

The proceedings in the High Court B

[9] The application was dismissed by Fabricius AJ, who held that the President had acted within his powers and in good faith. The fact that he had done so on the basis of incorrect advice and that as a result the Act had been brought into force prematurely was held not to be sufficient cause for reviewing the President's decision. C

[10] The seventh and eighth applicants sought leave from Fabricius AJ to appeal against his decision. That, too, was dismissed. They then applied for, and were granted, leave by the Supreme Court of Appeal to appeal to the Full Bench of the Transvaal High Court (the Full Bench). D

[11] The first six applicants did not participate in the appeal, which was pursued only by the seventh and eighth applicants. The Full Bench, Ngoepe JP and Swart and Nugent JJ, reversed the decision of Fabricius AJ and held that Proc R49 was null and void and of no force or effect. [13]

[12] In its judgment the Full Bench referred to the nature of the power exercised by the President in bringing an Act into operation, saying: F

'Often, as in the present case, administrative preparations are required to be made as a prerequisite to bringing the legislation into effect and it is best left to the executive branch of government to determine when the appropriate time has arrived. In the constitutional structure of this country it is the President, as the head of the executive branch of government, who is the appropriate person to whom to delegate that power. However, the power that he exercises in that regard is one that is delegated to him by Parliament and not one that is conferred upon him by the Constitution. In casu, such delegation was done through s 55 of Act 132 of 1998.

It is well established that delegated powers must be exercised within the limits of the authority that was conferred. If not, the purported exercise of the power is unlawful and a Court is quite entitled to set it aside as it would G set aside the unlawful act of any other functionary who has acted outside the powers conferred upon him by the Legislature.' [14]

[13] After citing from the judgments of Lord Sumner in the House of Lords in Roberts v Hopwood and Others [15] and Schreiner JA in the Appellate Division in Mustapha and Another v Receiver of H Revenue, Lichtenburg, and Others [16] as authority for the proposition that the President derived his power in the present case from the terms of the statute and had to act within the scope of such powers and any limitations imposed by them, the judgment concludes: I

Chaskalson P

Chaskalson P'In Our View What Is Plain Beyond Doubt Is that the Legislature Could Not Have Intended the President to Exercise Any Such Discretion at Least Until Such Time as the Act Was Capable of Being Given Effect To. that Was Manifestly Not the Case in Regard to the Act that Is Now under Consideration. We Think IT Is Clearly Implied in S 55 that Such Discretion as IT Conferred upon the President Would Not be Exercised before the Necessary Steps Had Been Taken to Ensure that the Act Could be Implemented Once IT Had Been Put into Effect. Indeed, in Our View, that Was the Very Purpose for which the Legislature Delegated the Relevant Power to the President. the Fact that the President Was Bona Fide in the Action that He Took Seems to Us to be Quite Irrelevant. Insofar as He Purported to Exercise Any Discretion that Was Conferred upon Him by the Legislature, He Did So Prematurely and without Yet Having the Authority to Do So. His Act Was Accordingly of NO Force or Effect. IT Follows that the Act Was Never Validly Brought into Effect and Accordingly the Earlier Legislation Has Not Yet Been Lawfully Repealed.'Above N 13 at 797i--798b. [17]

The referral to the Constitutional Court

[14] The Chief Registrar of the High Court was directed by the Judge President of that Court to bring the Full Bench's decision to the attention of this Court D in case the order made in that decision fell within the terms of s 172(2)(a) of the Constitution and had accordingly to be confirmed by this Court. Section 172(2)(a) provides:

'The Supreme Court of Appeal, a High Court or a Court of similar status may make an order concerning the constitutional validity of an Act of Parliament, a provincial Act or any conduct of the President, but an order of E constitutional invalidity has no force unless it is confirmed by the Constitutional Court.'

[15] On 8 September 1999, the order of the Full Bench was lodged with the Registrar of this Court...