Affordable Medicines Trust and Others v Minister of Health and Others

• Jurisdiction: South Africa
• Judge: Langa DCJ, Madala J, Mokgoro J, Moseneke J, Ngcobo J, O'Regan J, Sachs J, Skweyiya J, Van Der Westhuizen J and Yacoob J
• Judgment Date: 11 March 2005
• Citation: 2006 (3) SA 247 (CC)
• Docket Number: CCT 27/2004
• Hearing Date: 11 November 2004
• Counsel: H J Fabricius SC (with him S P Mothle) for the applicants/appellants. M T K Moerane SC (with him P Coppin and B Vally) for the first and second respondents. No appearance for the third to ninth respondents.
• Court: Constitutional Court

Ngcobo J:

Introduction

[1] This is an application for leave to appeal directly to this Court from the judgment and order of the Pretoria High Court dismissing a constitutional challenge to certain aspects of a licensing scheme D introduced by the government. In terms of this scheme, health care providers, such as medical practitioners and dentists, may not dispense medicines unless they have been issued with a licence to dispense medicines by the Director-General of the Department of Health (Director-General). The scheme also regulates the premises from which E medicines are dispensed. The challenge was directed at the powers of the Director-General to prescribe conditions upon which licences may be issued, the linking of a licence to dispense medicines to particular premises and the factors to which the Director-General is required to have regard when considering an application for a licence. F

Background

[2] The constitutional challenge was brought by the Affordable Medicines Trust, the National Convention on Dispensing and Dr Mabasa, who are first, second and third applicants respectively. The first applicant has as one of its objects the promotion of the 'rights' of G medical practitioners 'to dispense medicines to the general public'. The second applicant is a co-ordinating body which was established 'to act in the interest, and co-ordinate the activities, of its members'. [1] The third applicant is a medical practitioner who was authorised to dispense medicines under the now repealed s 52 of the Health Professions Act. [2] H The applicants allege that they act in their own interest, in the interest of,

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among other persons, medical practitioners 'who at present have a right and legitimate expectation to be able to dispense A medicines (without obtaining a licence) and to continue to do so', and in the public interest. They allege that they have the right to institute proceedings under s 38 of the Constitution. [3]

[3] The first and second respondents are the Minister of B Health and the Director-General respectively (the respondents), who opposed the application. The other respondents are the Speaker of Parliament, the President, the Health Professions Council of South Africa, the South African Pharmacy Council, the Medicines Control Council of South Africa, the Allied Health Professions Council of South C Africa and the South African Nursing Council. They are the third to the ninth respondents respectively, who each has an identifiable interest in the order sought by the applicants. No relief was sought against these respondents and they did not oppose the relief sought by the applicants. D

[4] In the High Court the applicants sought an order declaring invalid: [4]

(a)

Section 22C(1)(a) of the Medicines and Related Substances Act 101 of 1965 as amended (the Medicines Act), to the extent that it permits the Director-General to issue licences 'on the prescribed conditions' [5] ; and E

(b)

Regulations 18(3)(b), (f), (g), (h) and (i); 18(4); 18(5); 18(6); and reg 20 of the regulations made under the Medicines Act and

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published in Government Gazette 24727 under Government Notice R510 of 10 April 2003 (the A regulations). [6]

Amendment of reg 18

[5] Regulation 18 has, however, been amended. The regulations came into operation on 2 May 2003. On 16 October 2003, reg 18 was amended by Government Notice R1506 published in Government B Gazette 25593 by: (a) deleting para (c) of subreg (3); [7] and (b) inserting new subreg (4). [8] In its preamble, however, Government Notice R1506 provided that the existing subreg (4) becomes subreg (5), and said nothing about the remaining subregulations that were affected by the amendment. Thus on 31 October 2003, by C Government Notice R1565 published in Government Gazette 25622, a correction notice was issued to correct Government Notice R1506. The effect of the correction was to amend reg 18 by providing that subregs (4), (5), (6), (7) and (8) became subregs (5), (6), (7), (8) and (9) respectively. The two notices, read together, therefore D provide in effect that subregs (4), (5), (6), (7) and (8) now become subregs (5), (6), (7), (8) and (9) respectively.

[6] Now it is plain from these Government Notices that the substance of the regulations has not been amended. All that has changed are the numbers of the subregulations. Subregulations (4), (5), (6) and (7), which concern us in these proceedings, are now subregs (5), (6), (7) and (8) respectively. Their substance remains the same. These E amendments, which had already come into operation when the present proceedings were instituted in the High Court, were neither drawn to our attention nor that of the High Court. The relief sought by the applicants must be amended to reflect the correct subregulation numbers. F

[7] The present situation is different from that in the Satchwell case. [9] In that case, this Court was concerned with confirmatory proceedings and a major difference between the replaced statutory provisions and regulations and the old ones. In the light of this, this Court held that it could G not consider statutory provisions that had not been declared invalid by the High Court, and that the proper course to follow was to approach this Court by way of a direct access.

[8] Here we are not concerned with confirmatory proceedings. In H

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addition, there are no changes to the contents of the provisions. All that has changed are subregulation numbers. This is a matter which A could have been cured by an appropriate amendment of the notice of motion to reflect the correct subregulation numbers. It is difficult to see on what conceivable basis it could have been opposed. And I cannot conceive of any prejudice that would have been suffered by the respondents if the notice of motion were to have been amended. Even B if it had been opposed, it is the kind of amendment which would have been granted, had it been sought. It is a formal amendment.

[9] The principles governing the granting or refusal of an amendment have been set out in a number of cases. There is a useful collection of these cases and the governing principles in C Commercial Union Assurance Co Ltd v Waymark NO. [10] The practical rule that emerges from these cases is that amendments will always be allowed unless the amendment is mala fide (made in bad faith) or unless the amendment will cause an injustice to the other side which cannot be cured by an appropriate order for costs, or 'unless the parties cannot D be put back for the purposes of justice in the same position as they were when the pleading which it is sought to amend was filed'. [11] These principles apply equally to a notice of motion. The question in each case, therefore, is, what do the interests of justice demand? E

[10] It seems to me, therefore, that it is in the interests of justice that the relief sought by the applicants be amended so as to reflect the correct subregulation numbers. Accordingly, the references to subregs (4), (5) and (6) of reg 18 in the relief sought by the applicants will now be references to subregs (5), (6) and (7) respectively. F

The substance of the impugned provisions

[11] The impugned provisions are part of the legislative framework that brought about the licensing scheme. Section 22C(1)(a) of the Medicines Act makes provision for the Director-General to issue licences to health care providers to compound and dispense medicines 'on the prescribed conditions'. Regulation 18(3) sets out information G that must be contained in an application for a licence, while reg 18(5) sets out factors that the Director-General must have regard to when considering an application for a licence. Regulation 18(6) requires an applicant for a licence to publish the notice of intention to apply for a licence in a newspaper circulating in the area where the applicant H intends to conduct a practice. Regulation 20 provides that a licence is valid for a period of three years and makes provision for its renewal.

The legislative framework

[12] Prior to the introduction of the licensing scheme, the authority I of the medical practitioners to dispense or compound medicines was

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governed by s 52 of the Health Professions Act. Under this statute, all that was required of a medical practitioner who desired to compound A or dispense medicines as part of his or her practice was to inform the Health Professions Council of South Africa, the fifth respondent, of his or her intention to compound or dispense medicines. [12] At the discretion of the fifth respondent, the name of such medical practitioner would then be B entered in the register of medical practitioners who were allowed to compound or dispense medicines. Upon registration, a medical practitioner became entitled personally to dispense medicines prescribed by him or her or by any medical practitioner or dentist with whom he or she was in partnership or with whom he or she was 'associated as principal or associate or locum tenens'. [13] C

[13] With effect from 2 May 2004, the provisions of s 52 of the Health Professions Act were repealed and replaced by a new s 52. [14] In substance, the new s 52 now requires health care providers, including medical practitioners and dentists, to compound or dispense medicines 'only on the authority and D subject to the conditions of a licence granted by the Director-General under the [Medicines Act]'. [15] At about the same time the Medicines Act was amended by the insertion of ss 22C - 22H. [16]

[14] As pointed out earlier, s 22C(1)(a) [17] of the Medicines Act makes provision for the Director-General to issue licences to health E care providers to compound and dispense medicines 'on the prescribed

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conditions'. The issue of a...