Case number: 4183/98

In the matter between:

THE PHARMACEUTICAL MANUFACTURERS' ASSOCIATION OF SOUTH AFRICA
First Applicant

ALCON LABORATORIES (S.A.) (PROPRIETARY) LIMITED
Second Applicant

BAYER (PROPRIETARY) LIMITED
Third Applicant

BRISTOL-MYERS SQUIBB (PROPRIETARY) LIMITED
Fourth Applicant

BYK MADAUS (PROPRIETARY) LIMITED
Fifth Applicant

ELI LILLY (SOUTH AFRICA) (PROPRIETARY) LIMITED
Sixth Applicant

GLAXO WELLCOME (SOUTH AFRICA) (PROPRIETARY) LIMITED
Seventh Applicant

HOECSHT MARION ROUSSEL LIMITED
Eighth Applicant

INGELHEIM PHARMACEUTICALS (PROPRIETARY) LIMITED
Ninth Applicant

JANSSEN-CILAG PHARMACEUTICA (PROPRIETARY) LIMITED
Tenth Applicant

KNOLL PHARMACEUTICALS SOUTH AFRICA (PROPRIETARY) LIMITED
Eleventh Applicant

LUNDBECK SOUTH AFRICA (PROPRIETARY) LIMITED
Twelfth Applicant

MERCK (PROPRIETARY) LIMITED
Thirteenth Applicant

MSD (PROPRIETARY) LIMITED
Fourteenth Applicant

NOVARTIS SOUTH AFRICA (PROPRIETARY) LIMITED
Fifteenth Applicant

NOVO NORDISK (PROPRIETARY) LIMITED
Sixteenth Applicant

PHARMACIA & UPJOHN (PROPIETARY) LIMITED
Seventeenth Applicant

RHONE-POULENC RORER SOUTH AFRICA (PROPRIETARY) LIMITED
Eighteenth Applicant

ROCHE PRODUCTS (PROPRIETARY) LIMITED
Nineteenth Applicant

SCHERING (PROPRIETARY) LIMITED
Twentieth Applicant

SCHERING-PLOUGH (PROPRIETARY) LIMITED
Twenty-First Applicant

S.A. SCIENTIFIC PHARMACEUTICALS (PROPRIETARY) LIMITED
Twenty-Second Applicant

SMITHKLINE BEECHAM PHARMACEUTICALS (PROPRIETARY) LIMITED
Twenty-Third Applicant

UNIVERSAL PHARMACEUTICALS (PROPRIETARY) LIMITED
Twenty-Fourth Applicant

WARNER-LAMBERT S.A. (PROPRIETARY) LIMITED
Twenty-Fifth Applicant

WYETH (PROPRIETARY) LIMITED
Twenty-Sixth Applicant

XIXIA PHARMACEUTICALS (PROPRIETARY) LIMITED
Twenty-Seventh Applicant

ZENECA SOUTH AFRICA (PROPRIETARY) LIMITED
Twenty-Eight Applicant

BAYER AG
Twenty-Ninth Applicant

BOEHRINGER-INGELHEIM INTERNATIONAL GmbH
Thirtieth Applicant

BOEHRINGER-INGELHEIM KG
Thirty-First Applicant

BRISTOL-MYERS SQUIBB COMPANY
Thirty-Second Applicant

BYK GULDEN LOMBERG CHEMISCHE FABRIK GmbH
Thirty-Third Applicant

DR. KARL THOMAE GmbH
Thirty-Fourth Applicant

ELI LILLY AND COMPANY
Thirty-Fifth Applicant

F. HOFFMAN-LA ROCHE AG
Thirty-Sixth Applicant

MERCK KGaA
Thirty-Seventh Applicant

MERCK & CO., INC.
Thirty-Eighth Applicant

RHONE-POULENC RORER S.A.
Thirty-Ninth Applicant

SMITHKLINE BEECHAM
Fortieth Applicant

WARNER-LAMBERT COMPANY
Forty-First Applicant

OLIVER CORNISH
Forty-Second Applicant

and

THE PRESIDENT OF THE REPUBLIC OF SOUTH AFRICA, THE HONOURABLE MR N.R. MANDELA N.O.
First Respondent

THE SPEAKER OF THE NATIONAL ASSEMBLY, THE HONOURABLE DR. F.N. GINWALA N.O.
Second Respondent

THE CHAIRPERSON OF THE NATIONAL COUNCIL OF PROVINCES, THE HONOURABLE MR. M.G.P. LEKOTA N.O.
Third Respondent

THE MINISTER OF HEALTH, THE HONOURABLE DR. N.C. DLAMINI ZUMA N.O.
Fourth Respondent

THE CHAIRPERSON OF THE PORTFOLIO COMMITTEE ON HEALTH [NATIONAL ASSEMBLY], THE HONOURABLE DR. A.S. NKOMO N.O.
Fifth Respondent

THE CHAIRPERSON OF THE SELECT COMMITTEE ON SOCIAL SERVICES [COUNCIL OF PROVINCES], THE HONOURABLE DR. S.C. CWELE N.O.
Sixth Respondent

THE CHAIRPERSON OF THE MEDICINES CONTROL COUNCIL, PROFESSOR P.I. FOLB N.O.
Seventh Respondent

THE PREMIER OF THE GAUTENG PROVINCE, THE HONOURABLE MR. M. MOTSHEKGA N.O.
Eighth Respondent

THE MEMBER OF THE EXECUTIVE COMMITTEE FOR HEALTH OF THE GAUTENG PROVINCE, THE HONOURABLE MR. A. MASONDO N.O.
Ninth Respondent

THE REGISTRAR OF PATENTS MR. C. BURTON-DURHAM N.O.
Tenth Respondent

BE PLEASED TO TAKE NOTICE that Applicants intend to apply to the above Honourable Court, on a date to be arranged with the Registrar of the above Court, for an order in the following terms:

That an interim interdict issue in terms of which the First and Fourth Respondents are interdicted and prohibited pending the final outcome of this application form publishing a notice in terms of Section 33 of the Medicines and Related Substances Control Amendment Act, No. 90 of 1997 [hereinafter referred to as "The Amendment Act"] by which the following sections fo the Amendment Act shall come into operation thereby to amend the Medicines and Related Substances Control Act, No. 101 of 1965 [hereinafter referred to as "The Principal Act"], namely:

1.1 Sub-section 1(d);

1.2 Sub-section 1(j);

1.3 Sub-section 1(k);

1.4 Section 3;

1.5 Section 4;

1.6 Section 5 insofar as it introduces sub-section 6(1)(d) to the Principal Act;

1.7 Section 6;

1.8 Section 7;

1.9 Section 10;

1.10 Section 14 insofar as it introduces Section 22F to the Principal Act;

1.11 Section 14 insofar as it introduces sub-sections 22G(2) and (3) to the Principal Act;

1.12 Section 23 insofar as it introduces into the Principal Act

1.12.1 the requirement that the Minister is to act "in consultation with the council" in making regulations in terms of Section 35(1);

1.12.2 sub-section 35(1)(xxxvi);

1.12.3 sub-section 35(1)(xxxvii);

1.12.4 sub-section 35(1)(xxxviii);

1.12.5 sub-section 35(8)

Declaring that Section 10 of the Amendment Act introducing Section 15C of the Principal Act is unconstitutional on one or more all of the following grounds:

2.1 it enables and authorises the Fourth Respondent, in conflict with Sections 43 and 44 of the Constitution of the Republic of South Africa, 1996, Act 108 of 1996 [hereinafter referred to as "the Constitution"]to determine "prescribed conditions" for the supply of "more affordable medicines" in "certain circumstances" without setting out policy considerations or any guidelines, alternatively sufficient guidelines, which would serve to limit the Fourth Respondent's authority and power to do so.

2.2 it enables and authorises the Fourth Respondent: in conflict with Sections 43 and 44 of the Constitution, to "determine" the extent to which rights under a patent granted in the Republic shall apply irrespective of the provisions of the Patents Act, No. 57 of 1978;

2.3 it enables and authorises the Fourth Respondent, in conflict with Section 25 of the Constitution, to deprive owners of intellectual property in respect of pharmaceutical products of such property, alternatively to expropriate such property without any provision for compensation to be paid in respect thereof;

2.4 it is discriminatory in respect of the enjoyment of patent rights in the pharmaceutical field which discrimination is in conflict with the provisions of Article 27 of the Trade Relates Aspects of Intellectual Property Rights Agreement [hereinafter referred to as the "TRIPS Agreement"], an international agreement binding the Republic and to which Parliament has given effect by the promulgation of the Intellectual Property Laws Amendment Act, No. 38 of 1997, and consequently such provision is in conflict with Section 44(4) of the Constitution read with Sections 231(2) and 231(3) of the Constitution;

Declaring the Section 1(k) of the Amendment Act introducing Section 1(4) of the Principal Act read with Section 35(I)(xxxviii) of the Principal Act introduced by Section 23 of the Amendment Act is unconstitutional in that it

3.1 authorises and enables the Fourth Respondent, in conflict with Sections 43 and 44 of the Constitution arbitrarily and capriciously to prescribe the "manner" and "conditions" on which international rendering for medicines shall be allowed without setting out any policy considerations or guidelines in regard to the manner and conditions which would limit the Fourth Respondent's authority and power to do so;

3.2 authorises and enables the Fourth Respondent, in conflict with Section 9 of the Constitution read with Section 8 of the Constitution to discriminate in favour of imported medicines to the detriment of the manufacturers of local products.

Declaring that Section 14 of the Amendment Act insofar as it introduces Section 22F of the Principal Act is unconstitutional in one or more or all of the following respects;

4.1 the section, read with Section 1 of the Amendment Act insofar as it introduces Section 1(d) of the Principal Act and with Section 23 of the Amendment Act insofar as it introduces Section 35(I)(xxxvi) of the Principal Act, authorises and enables the Fourth Respondent, in conflict with Sections 43 and 44 of the Constitution, to control the practice of substitution of prescribed medicines by being authorised and enabled to prescribe "requirements for therapeutic equivalence" without any guidelines, standards or policy considerations which would limit the Fourth Respondent's authority to do so;

4.2 it discriminates unfairly in favor of the manufacturers of products qualifying as interchangeable multi-source medicines of a prescribed medicine, and to the detriment of the manufacturer of such prescribed medicine, in conflict with Section 9 of the Constitution read with Section 8 of the Constitution;

4.3 it enables the Fourth Respondent in conflict with Section 25 of the Constitution to deprive the owner of the prescribed medicine of its property, alternatively to expropriate such property without compensation;

4.4 it forces a pharmacist, in conflict with Section 16(1)(b) of the Constitution, to inform members of the public of the "benefits of substitution" regardless as to whether the pharmacist is of the view that substitution is beneficial or not;

4.5 it interferes with the right of pharmacists to dispense a prescribed medicine and obliges pharmacists to dispense an interchangeable multi-source medicine solely on the basis of price and is hence in conflict with Section 22 of the Constitution read with Section 8 of the Constitution;

Declaring that Section 14 of the Amendment Act insofar as it introduces sub-sections 22G(2) and (3) of the Principal Act is unconstitutional in one or both of the following respects:

5.1 the sub-sections provide for and allow, in conflict with Section 9 of the Constitution read with Section 8 of the Constitution, unfair discriminatory treatment of pharmaceutical manufacturers, pharmacists and holders of licences as contemplated in Section 22C(1)(a) of the Principal Act as introduced by Section 14 of the Amendment Act, inasmuch as the burdens imposed upon such pharmaceutical manufacturers, pharmacists and holders of permits are not imposed upon other participants in that market;

5.2 the sub-sections are in conflict with Section 22 of the Constitution in that the freedom of trade of pharmaceutical manufacturers, pharmacists and holders of permits affected thereby is restricted thereby to such an extent that the essence of the right enshrined in Section 22 of the Constitution is nullified;

Declaring that one or more or all of the following sections of the Amendment Act are unconstitutional in that it or they conflict with Section 195 of the Constitution, namely

6.1 Section 3 substituting Section 3 of the Principal Act;

6.2 Section 4 substituting Section 4(1) of the Principal Act;

6.3 Section 5 insofar as it introduces sub-section 6(1)(d) of the Principal Act;

6.4 Section 6 substituting Section 9(1)(a) of the Principal Act;

6.5 Section 7 substituting Section 12(1) of the Principal Act;

6.6 Section 23 insofar as it allows the Minister to act merely "in consultation with" the Council and no longer on the recommendation of the Council, in making regulations in terms of Section 35(1) of the Principal Act;

6.7 Section 23 insofar as it introduces Section 35(8) of the Principal Act.

Declaring that Section 23 insofar as it introduces Section 35(8) is unconstitutional in that it authorises and allows the Fourth Respondent, in conflict with Sections 43 and 44 of the Constitution, to make regulations relating to any matters referred to in sub-section (1) of Section 35 of to amend or repeal any regulation made in terms of that sub-section, without setting out any of adequate policy considerations or guidelines which would limit the Fourth Respondent's authority and power to do so.

Ordering that one or more or all of the following sections and sub-sections of the Amendment Act be struck down.

8.1 Sub-section 1(d);

8.2 Sub-section 1(j);

8.3 Sub-section 1(k);

8.4 Section 3;

8.5 Section 4;

8.6 Section 5 insofar as it introduces sub-section 6(1)(d) to the Principal Act;

8.7 Section 6;

8.8 Section 7;

8.9 Section 10;

8.10 Section 14 insofar as it introduces Section 22F to the Principal Act;

8.11 Section 14 insofar as it introduces sub-sections 22G(2) and (3) to the Principal Act;

8.12 Section 23 insofar as it introduces into the Principal Act

8.12.1 the requirement that the Minister is to act "in consultation with the council" in making regulations in terms of Section 35(1);

8.12.2 sub-section 35(1)(xxxvi);

8.12.3 sub-section 35(1)(xxxvii);

8.12.4 sub-section 35(1)(xxxviii);

8.12.5 sub-section 35(8).

Ordering that the aforementioned orders of the above Honourable Court be referred to the Honourable Constitutional Court of the Republic of South Africa in accordance with the provisions of Section 173 of the Constitution.

IN THE ALTERNATIVE, AND IN ADDITION TO THE AFOREGOING:

Referring the prayer for an order in the following terms to the Constitutional Court:

10.1 It is declared that the Amendment Act was passed by Parliament in conflict with its constitutional obligations imposed upon it by Section 59(1) and 72(1) of the Constitution in that Parliament failed to:

10.1.1 facilitate public involvement in the legislative process by which the Amendment Act was passed;

10.1.2 conduct its business in an open manner;

10.1.4 take into consideration the recommendations made to the Portfolio Committee on Health [National Assembly] and the Select Committee on Social Services [Council of Provinces] by the public, and, in particular;

10.1.5 pay attention to scientific, medical, pharmaceutical and legal submissions made to the aforesaid committees by members of the public, including the Applicants;

11. Ordering the Second and the Fifth Respondents to transmit all the submissions received from the public, as well as a transcript of all the proceedings before the Portfolio Committee on Health [National Assembly] and the National Assembly itself in regard to the Bill which preceded the passing of the Amendment Act, to the Constitutional Court as part of the record of these proceedings;

12. Ordering Third and Sixth Respondents to transmit all the submissions received from the public, as well as a transcript of the proceedings before the select committee on Social Services [Council of Provinces] and the Council of Provinces in respect of the said Bill, to the Constitutional Court as part of the record in the matter so referred to the Constitutional Court;

13. Granting such further and/or alternative relief to the Applicants as the above Honourable Court may deem fit and proper; and

14. Ordering the Fourth Respondent, together with any other Respondent who may appear to oppose the relief sought by the Applicants, to pay the costs of this application.

TAKE FURTHER NOTICE that Applicants will rely on the affidavits of

together with the annexes thereto, in support of this application.

TAKE FURTHER NOTICE that the Applicants have appointed D.M. KISCH Inc., Parklands Building, Suite 3, 223 Bronkhorst Street, New Muckleneuk, PRETORIA at which they will accept notice and service of all process in these proceedings.

TAKE NOTICE FURTHER that if you intend opposing this application you are required:

[a] to notify the Applicants' attorney in writing on or before 13 March 1998;

[b] and within fifteen days after you have so given notice of your intention to oppose the application, to file your answering affidavits, if any; and further that you are require to appoint in such notification an address referred to in rule 6(5)(b) at which you will accept notice and service of all documents in these proceedings.

If no such notice of intention to oppose be given, the application will be made on 24 March 1998 at 10 a.m. or so soon thereafter as Counsel may be heard.

DATED at PRETORIA on this 18 day of February, 1998.

N.J. VERMAAK
APPLICANT'S ATTORNEY
D.M. KISCH INC.
PARKLANDS BUILDING
SUITE 3
223 BRONKHORST STREET
NEW MUCKLENEUK
PRETORIA

TO:

The Registrar of the above Honourable Court
corner Vermeulen & Paul Kruger Streets
PRETORIA

AND TO:

The First, Second, Third, Fourth, Fifth
Sixth, Eighth & Ninth Respondents
c/o The State Attorney
4th Floor South

Fedlife Forum Tower
Van der Walt Street
PRETORIA

AND TO:

The Chairperson of the Medicines Control Council
Hallmark Building
226 Vermeulen Street
PRETORIA

AND TO:

The Tenth Respondent
The Patent Office
Zanza Building
116 Proes Street
PRETORIA