Genmark Pharma Ltd v Minister for Health

• Jurisdiction: Ireland
• Judge: Ms. Justice ???Carr???
• Judgment Date: 01 January 1998
• Neutral Citation: [1997] IEHC 121
• Docket Number: [1994 J.R. 410]
• Court: High Court
• Date: 01 January 1998

[1997] IEHC 121

THE HIGH COURT

JR 410/1994

GENMARK v. MIN FOR HEALTH

BETWEEN

GENMARK PHARMA LIMITED

???CANT???

???T???

???NDENT???

Citations:

HEALTH (DELEGATION OF MINISTERIAL FUNCTION) ORDER 1993 SI 62/1993

EEC DIR 65/65 ART 3

EEC DIR 75/318 ART 2

MEDICAL PREPARATIONS (LICENSING ADVERTISEMENT & SALE) REGS 1984 SI 210/1984 ART 9(1)

EEC DIR 65/65 ART 5

EEC DIR 65/65 ART 7

EEC DIR 65/65 ART 12

EEC DIR 65/65 ART 21

MEDICAL PREPARATIONS (LICENSING ADVERTISEMENT & SALE) REGS 1984 SI 210/1984 ART 4

EEC DIR 75/318 ANNEX PART 4

EEC DIR 75/318 PART 4 SECTION F

EEC DIR 75/318 PART 4 SECTION G

NATIONAL DRUGS ADVISORY BOARD (ESTABLISHMENT) ORDER 1966 SI 163/1966

HEALTH (CORPORATE BODIES) ACT 1961

RSC O.84 r20(4)

MEDICAL PREPARATIONS (LICENSING ADVERTISEMENT & SALE) REGS 1984 SI 210/1984 ART 7(3)

FLANAGAN V UNIVERSITY COLLEGE DUBLIN 1988 IR 724

JEFFS V NEW ZEALAND DAIRY PRODUCTION & MARKETING BOARD 1967 1 AC 551

GERAGHTY V MIN FOR LOCAL GOVT 1976 IR 153

MEDICAL PREPARATIONS (LICENSING ADVERTISEMENT & SALE) REGS 1984 SI 210/1984 ART 9(1)(a)

MEDICAL PREPARATIONS (LICENSING ADVERTISEMENT & SALE) REGS 1984 SI 210/1984 ART 9(1)(b)(iii)

O'KEEFFE V BORD PLEANALA 1993 1 IR 39

Synopsis:

- [1998] 3 IR 111

1 Judgment of Ms. Justice ???Carr???

2 This is an Application for Judicial Review by way of Certiorari quashing a decision of the Minister of State at the Department of Health dated the 20th May, 1994 under powers delegated to him by the Minister for Health, which refused an application for product authorisation for a drug known as Edelfonsine. The power was delegated under the Health (Delegation of Ministerial Function) Order, S.I. No. 62 of 1993. No point is taken in relation to this delegation. References to "the Minister" include the Minister for Health or the Minister for State (as the case may be). The Applicant, Genmark Pharma Limited ("Genmark"), also seeks declarations that the Minister failed properly to apply EC Directives 65/65 (as amended) and 75/318 (as amended) as also Statutory Instrument No. 210 of 1984, being the Medical Preparations (Licensing Advertisement and Sale) Regulations 1984.

3 EC Directive 65/65 (as amended) provided in Article 3 that no medicinal product could be placed on the market of a member state unless a marketing authorisation had been issued by the competent authority of that member State in accordance with the relevant procedures. Article 5 provided that an authorisation should be refused if (inter alia):-

"After verification of the particulars and documents listed in Article 4 it proves that the proprietary medicinal product is harmful in the normal conditions of use or that its therapeutic efficacy is lacking or is insufficiently substantiated by the applicant....."

4 There is provision under Article 7 that the procedure should be completed within 120 days of the date of application. In certain circumstances this could be extended for a further 90 days.

5 Where an application is refused, Article 12 provides that the decision should be notified to the party concerned stating in detail the reasons on which it was based and at the same time the party shall be informed of the remedies available under the law in force and the time limit allowed for the exercise of those remedies. Article 21 provides that an authorisation to market a medicinal product shall not be refused, suspended or revoked except on the grounds set out in the directive.

6 The statutory instrument implementing Directive 65/65 (as amended) is the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984, S.I. 210 of 1984 ("the 1984 Regulations"). Under those regulations medical preparations could only be sold or manufactured if licensed for that purpose under the regulations by the Minister (Article 4). This is referred to as "product authorisation".

7 The Minister was designated the competent authority for the grant of product authorisations. Article 7 of the 1984 Regulations provides:-

8 2 "(1). An application for a product authorisation shall be made to the Minister and shall be in such form and be accompanied by the appropriate charge provided for under Article 10 and by such information documents, samples and other materials as the Minister may require.

9 (2) ......(revoked).

10 (3) In the examination and determination of an application for a product authorisation, the Minister shall take into consideration such criteria as appear to him to be relevant in the case of the application and, in particular, the information supplied by the applicant in relation to

11 (a) the safety and efficacy of the medical preparation to which the application relates and the purpose for which the medical preparation is intended by the applicant to be administered, and

12 (b) the quality of the medical preparation."

13 Article 9(1) of the 1984 Regulations provides:-

"(1) The Minister may refuse an application for a product authorisation where -"

(a) the applicant fails to submit information, documents, samples or other materials in accordance with Article 7(1), or

(b) the Minister is satisfied, following examination of such information, documents, samples or other materials that -

14 ......

15 (iii) the therapeutic efficacy of the preparation is lacking or is insufficiently substantiated by the applicant........"

16 This mirrors the provisions of Article 5 of Directive 65/65.

17 Directive 65/65 was amended by Directive 75/318 and 91/507. Among the recitals to Directive 75/318 it is stated:-

"Whereas the concepts of "harmfulness" and "therapeutic efficacy" referred to in Article 5 of Directive 65/65 can only be examined in relation to each other and have only a relative significance depending on the progress of scientific knowledge and the use for which the (...) medicinal product is intended; whereas the particulars and documents which must accompany an application for authorisation to place a (...) medicinal product on the market demonstrate that potential risks are outweighed by the therapeutic efficacy of the product; whereas failing such demonstration the application must be rejected; whereas the evaluation of "harmfulness" and "therapeutic efficacy" may be modified in the light of new discoveries and standards and protocols must be amended periodically to take account of scientific progress."

18 Article 2 provides:-

"Notwithstanding the provisions of other directives on (...) medicinal products, Member States shall take all appropriate measures to ensure that the competent authorities examine the particulars and documents submitted in support of applications for marketing authorisation in accordance with the criteria of the Annex to this directive."

19 Part 4 of the Annex deals with clinical documentation.

20 Part 4, Section F is headed "Clinical Efficacy and Safety" and provides (at paragraph 1):-

"(1) In general, clinical trials shall be done as "controlled clinical trials" and if possible, randomised; any other design shall be justified. The control treatment of the trials will vary from case to case and also will depend on ethical considerations; thus it may, in some instances, be more pertinent to compare the efficacy of a new medicinal product with that of an established medicinal product of proven therapeutic value rather than with the effect of a placebo. As far as possible, and particularly in trials where the effect of the product cannot be objectively measured, steps should be taken to avoid bias, including methods of randomisation and blinding."

21 Part 4, Section G is headed "Documentation for Applications in exceptional circumstances". It provides that when in respect of particular therapeutic indications, the applicant can show that he is unable to provide comprehensive data on the quality, efficacy and safety under normal conditions of use because (inter alia) it would be contrary to generally accepted principles of medical ethics to collect such information, marketing authorisation might be granted subject to certain conditions.

22 The medical product concerned in this case is Edelfonsine. It is intended for use in cases of inoperable small cell lung cancer. Dr. Rabbe Nordestroem who swore the grounding affidavit says that it is an anti neoplastic agent unlike chemotherapy drugs which operate to destroy the neoplastic cells. Edelphonsine operates to induce cells to terminal proliferation or to inability to proliferate. It was invented by scientists of the Max Planck Society in Germany and a German company, Medmark Pharma GmBh, was licensed to develop and exploit the invention in 1987.

23 Genmark is an associated company of Medmark Pharma and plans to manufacture the drug in Ireland if permitted. Doctor Nordstroem sets out claims for the efficacy of the drug but the Court is not concerned with the question of efficacy. It is only concerned with the validity of the decision making process.

24 The application for product authorisation for Edelfonsine was made by Waterford Clinical Associates Limited (t.a. Shandon Clinic) on the 7th March, 1991 to the Secretary of the Department of Health. In the application form the company is stated to be the "product authorisation holder".

25 This was acknowledged on the 7th March, 1991 and the company was told that the application would be processed in consultation with the National Drugs Advisory Board ("the NDAB"). It was therefore necessary to furnish the NDAB with such information and facilities as they might require in the course of examination of the application for the purpose of advising the Minister.

26 The application comprised 45 volumes of text in German. Doctor Teeling of the NDAB wrote to Professor Cleary of Shandon Clinic on the 5th February, 1992 to say that dossier had been found to be impossible to assess and asking the company to resubmit the...