Reitzer Pharmaceuticals (Pty) Ltd v Registrar of Medicines and Another

• Jurisdiction: South Africa
• Judgment Date: 11 March 1998
• Citation: 1998 (4) SA 660 (T)

Reitzer Pharmaceuticals (Pty) Ltd v Registrar of Medicines and Another
1998 (4) SA 660 (T)

1998 (4) SA p660

Citation	1998 (4) SA 660 (T)
Case No	10842/98
Court	Transvaal Provincial Division
Judge	De Villiers J
Heard	May 28, 1996
Judgment	March 11, 1998
Counsel	SE Weiner (with her GJ Marcus) for the applicant; EW Dunn (with him JA Van Der Westhuizen) for the respondents

Flynote : Sleutelwoorde B

Constitutional law — Human rights — Right freely to engage in economic activity in terms of s 26(1) in chap 3 of Constitution of the Republic of South Africa Act 200 of 1993 — Whether limitation of right by definition of 'medicine' in s 1 C of Medicines and Related Substances Control Act 101 of 1965, read with ss 14 and 19, reasonable and justifiable — Section 26(1) constitutional right limited by Act to achieve widest and most efficient form of regulation and control of medicines in interests of public — Importance of such purpose self-evident — Limitation not negating essential content D of right — Thus reasonable and justifiable that 'medicine' widely defined — Reasonable possibility, however, that Constitutional Court might reach different conclusion — Matter referred to Constitutional Court.

Constitutional practice — Interim interdict — Pending referral to Constitutional Court of validity of Act of Parliament — Issue whether wide definition of 'medicine' in s 1 of Medicines and Related Substances Control Act 101 of 1965, read with E ss 14 and 19, unreasonable and unjustifiably limiting right freely to engage in economic activity in terms of s 26(1) of Constitution of the Republic of South Africa Act 200 of 1993 — Applicant pharmaceutical company seeking to interdict respondent from preventing it from manufacturing, selling and distributing product pending referral — Product called up F for registration under Act — Applicant refusing to apply for registration on grounds that product not a medicine — Respondents public authorities charged with duty of promoting and protecting public interest through mechanisms of Medicines and Related Substances Control Act by regulating and controlling medicines — Fact that product not G containing any inherently harmful ingredient not conclusive — Failure to apply for registration making review of safety, quality and efficacy of product impossible — Harm applicant might suffer as result of enforcement of Act outweighed by public interest and interests of respondents — Interdict refused.

Headnote : Kopnota

The applicant pharmaceutical company sought an order referring to the Constitutional Court the question whether H the definition of 'medicine' in s 1 of the Medicines and Related Substances Control Act 101 of 1965 (the Act), read with ss 14 and 19 of that Act, was in conflict with the provisions of s 26(1) of the Constitution of the Republic of South Africa Act 200 of 1993 (the Constitution). It also sought an order, pending the decision of the I Constitutional Court, interdicting the respondents from preventing it from manufacturing, selling and distributing one of its products, Florex. Florex, a dried yeast product, was prescribed by doctors and used by patients as an anti-diarrhoeal to be used as an adjunct to antibiotic therapy, the (as yet unproven) theory being that it would restore the flora in the intestines destroyed by the use of antibiotics. The product was sold in pharamaceutical dosages in capsule form. J

1998 (4) SA p661

All anti-diarrhoeals which were not available for sale immediately before 5 July 1968 were called up for A registration in terms of a resolution of the Medicine Control Council, approved by the second respondent Minister and published in the Government Gazette of 5 July 1968. Florex had not been available for sale before that date and had therefore been called up for registration. Sales of medicines subject to registration but which have not been registered are prohibited by s 14 of the Act. The applicant's case was that Florex was a dietary B supplement, not a medicine, and would therefore not have been subject to registration under the Act save for the over-broad definition of 'medicine' in s 1. Although at the time of the application no medicinal claims were being made in the advertising and packaging material, at the time of its launch the Florex label had indicated that it was intended 'for concurrent use with antibiotic therapy . . . or as prescribed by your doctor'. Further indications that C the applicant regarded Florex as an anti-diarrhoeal were, inter alia, that it regarded Inteflora, a product manufactured, sold and used for a similar purpose, as a competitor and the manner in which Florex had been marketed on the applicant's behalf. The applicant's attack on the definition of 'medicine' was primarily directed at the word 'used' in the introductory phrase on the grounds that, for example, even water would fall under the D definition of 'medicine' if it were used to treat or cure thirst.

Held, that to meet the requirements for a competent reference in terms of s 102(1) of the Constitution the applicant would have to convince the Court that (a) there was an issue in the matter which might be decisive for the case; (b) the issue fell within the exclusive jurisdiction of the Constitutional Court (this was common cause E between the parties); (c) it would be in the interests of justice that the issue be referred to the Constitutional Court; and (d) there was a reasonable prospect that the relevant law or provision would be held to be invalid. (At 668G--669B.)

Held, further, as to whether the issue would be decisive of the case, that, if a statute was over-broad, it fell to be F struck down regardless of whether or not the party challenging the measure fell within the terms of a more narrowly-tailored statute. (At 669G--H, read with 671D/E--E.)

Held, further, as to the applicant's prospects of success, that the definition of 'medicine' and the provisions of ss 14 and 19 placed a limitation on the right freely to engage in economic activity enshrined in s 26(1) of the Constitution. (684B/C.) G

Held, further, that, although the right freely to engage in economic activity was an important right in an open and democratic society based on freedom and equality, the purpose for which the right was limited by the Act was to achieve the widest and most efficient form of regulation and control of medicines in the interests of the public. The importance of such purpose spoke for itself - without proper regulation and control the health of the public would H be endangered. (At 684C/D--D/E.)

Held, further, that the limitation was not over-broad: the efficacy of the limitation lay in the control and regulation provided for in the Act. The limitation did not negate the essential content of the right in question. It was reasonable and justifiable that 'medicine' be widely defined. (At 684D/E--F.)

Held, further, applying some of the basic principles of statutory interpretation, that an adherence to the literal I wording and meaning to include water used merely for drinking purposes within the definition of 'medicine' would give rise to an absurdity so glaring that it could not have been contemplated by the Legislature or would lead to a result contrary to the Legislature's intention. (At 685D/E--E/F.)

Held, further, even assuming that the Act prima facie exceeded the limits imposed

1998 (4) SA p662

by chap 3 of the Constitution, that, although the 'therapeutic purpose' of the substance was more strongly A pronounced in para (a) of the definition of 'medicine' than in para (b), both paragraphs were intended to refer to substances used for therapeutic or medicinal purposes. In that case, then, water used merely to quench thirst, although it might prima facie be included under para (b), would not be used for a therapeutic or medicinal B purpose and would therefore not fall within the definition of 'medicine'. (At 685G--686F, summarised.)

Held, accordingly, given the provisions of s 35(2) of the Constitution, that the Act was reasonably capable of a more restricted interpretation which did not exceed the limits of any of the rights in chap 3 of the Constitution. (At 686F--F/G.) C

Held, further, however, that there was a reasonable possibility that the Constitutional Court might reach a different decision and conclude that the definition of 'medicine' was over-broad. The matter should therefore be referred to that Court in view of the constitutional importance of the issue and the public interest involved in settling the issue. (At 688E/F--G.)

Held, further, as to the application for an interim interdict, that the issue should be decided on the basis of D whether (1) a serious question had been raised for trial in the Constitutional Court; (2) there was a real prospect that the applicant might suffer irreparable harm if the relief were not granted; and (3) the balance of convenience, the adjudication of which would require a gloss not present in ordinary applications for interim interdicts, favoured the applicant. (At 690A--B.)

The dictum in Ferreira v Levin NO and Others; Vryenhoek and Others v Powell NO and Others 1995 (2) SA 813 (W) at 833--2 applied. E

Held, further, accepting in the applicant's favour that it had established a sufficient degree of potentially irreparable prejudice and, in view of the finding that there was a reasonable possibility that the Constitutional Court might hold in the applicant's favour, that the applicant had raised a serious question for trial in that Court, F that requirements (1) and (2) above had been satisfied. (At 690B/C--C and D--D/E.)

Held, further, as to the third aspect, that since there was merely a reasonable possibility that the Constitutional Court might uphold the applicant's contentions, its chances of ultimate success were weak...