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Lawsuit against the Goverment of South Africa (February 18, 1998)
Here is the text of the drug company lawsuit (Feb 18, 1998) against the Government of South Africa. This concerns South Africa's "Medicines and Related Substances Control
Amendment Act, No. 90 of 1997.
There are forty-two applicants respresenting a host of multinational and South African drug companies as well as South African subsidiaries of multinational pharmaceutical
companies.
There are ten respondents in this case. The first respondent is the former President of South Africa, Nelson Mandela. The fourth respondent is Dr. N.C. Dlamini Zuma,
South Africa's Minister of Health.
This is also available on the Consumer Project on Technology's South Africa page at:
http://www.cptech.org/ip/health/sa/pharmasuit.html
Thiru Balasubramaniam
Consumer Project on Technology
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NOTICE OF MOTION
In the High Court of South Africa
(Transvaal Provincial Division)
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
NOTICE OF MOTION
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:
1.
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)
2.
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;
3.
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.
4.
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;
5.
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;
6.
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.
7.
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.
8.
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).
9.
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:
10.
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
1. MIRRYENA THEREZA DEEB
2. WILLIAM DUNCAN REEKIE
3. FRANK GYLDENLOVE MADSEN
4. JACOBUS JOHANNES VAN WYK
5. MAUREEN KIRKMAN
6. NICOLAAS JACOBUS VERMAAK
7. DONALD SKEEN SIMPSON
8. RICHARD ANTHONY DE CHASTELAIN
9. TIMOTHY DAVID LUDLOW
10. JAN LOUIS VENTER
11. NOEL HARLEY DOLMAN
12. PAT SMITH
13. JEAN-PIERRE BRIAM
14. PAUL BARLOW STEWART
15. JACOBUS DANIEL VENTER
16. DEON JURGENS
17. BERNHARD ALAN CRISTEN
18. DEON DE KOCK VOS
19. DONALD DE KORTE
20. LOTHAR EHRHARDT
21. RONALD FRANK CHRISTIE
22. PAUL VINCENT DODSEN
23. ROGER BARRY HEMINGWAY
24. PAUL ANTHONY NEWTON-SYMS
25. ROBERT IAN GOODALL
26. IAN DANIEL BEKKER
27. ANTON PIETER DE KOCK
28. GUNTHER LUDWIG FABER
29. ABE EGDES
30.GORDON KNAPP
31. ERICA L. MANN
32. PAUL ANTHONY GLOVER
33. DIETER LAUDIEN
34. SUPPLEMENTARY AFFIDAVIT OF DIETER LAUDIEN
35. HEINZ WOLF BULL
36. OLIVER CORNISH
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, Fiffth
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
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