Pco Manufacturing Ltd v Irish Medicines Board

• Jurisdiction: Ireland
• Court: Supreme Court
• Judge: Mr Justice Francis D Murphy
• Judgment Date: 22 May 2001
• Neutral Citation: [2001] IESC 46
• Docket Number: No 446JR/1998
• Date: 22 May 2001

PCO MANUFACTURING LTD v. IRISH MEDICINES BOARD

Judicial Review

BETWEEN:

PCO MANUFACTURING LTD

APPLICANT/APPELLANT

AND

THE IRISH MEDICINES BOARD

RESPONDENT

[2001] IESC 46

No 446JR/1998

APPEAL No 117/00

THE SUPREME COURT

Synopsis

Practice and Procedure

Practice and procedure; judicial review; jurisdiction of court to order plenary hearing; function of respondent to determine applications for import, placing on the market or sale of medicinal products; applicant had a number of outstanding applications before the respondent and alleged delay by respondent in dealing with same; applicant granted leave to apply for certain reliefs by way of judicial review; statement grounding application for judicial review also included claim for damages for loss of profits caused by alleged delay; by notice of motion applicant had sought High Court order directing that application for judicial review insofar as it related to reliefs sought should be heard and determined prior to claim for damages; respondent sought order directing a plenary hearing of the proceedings; High Court declined to order a "split trial" in relation to the reliefs sought and the claim for damages and ordered that proceedings should stand adjourned to plenary hearing; whether Court should order separate hearings of the issues; whether splitting issues would offer any significant advantages to either party or reduce demands on judicial time; whether trial judge had jurisdiction to direct that the matter should stand adjourned to plenary hearing.

Held: Appeal dismissed.

PCO Manufacturing Ltd. v. Irish Medicines Board - Supreme Court: Murphy J., Murray J., McGuinness J. - 22/05/2001

The applicant had initiated judicial review proceedings regarding the approval by the respondent of medicinal products. The applicant claimed that the respondent had been guilty of excessive delay in issuing product authorisations. In the High Court Mr. Justice Kelly directed that the matter proceed by way of plenary hearing and declined to order a “split trial”. The applicant appealed. Murphy J, delivering judgment, held that the Supreme Court should not lightly review such a matter. The High Court order would be affirmed and the appeal dismissed.

Citations

IRISH MEDICINES ACT 1995

EEC DIR 65/65

EEC DIR 81/851

RSC O.39 r9

MILLAR V PEEPLES 1995 NI 6

MCCABE V IRELAND 1999 4 IR 151

IN THE MATTER OF COMET FOOD MACHINERY COMPANY 1999 1 IR 485

VELLA V MORELLI 1968 IR 11

Judgment of

Mr Justice Francis D Murphy

delivered the22nd day of May, 2001 [nemdiss]

1 The above named Respondent (the Board) was set up under the Irish Medicines Act,1995.The functions of the Board include the exercise of the powers conferred on the competent authority by Council Directive No. 65/65/EEC of the 26th January, 1965, and Council Directive No. 81/851/EEC of 28th September, 1981. It is the contention of the above named Appellant (PCO) that it is the duty of the Board not merely to determine but to determine promptly applications to obtain authorisations for the import, placing on the market or sale of medicinal products in free circulation in another member state or states of the European Union.

2 The PCO from time to time made applications to the Board both for product authorisations and for renewals of product authorisations. PCO expressed their concern to the Board at what they contended was the delay in dealing with such applications.

3 It appears that in November, 1998, fifty-two applications by PCO were outstanding. Thirty-two were applications for product authorisations and twenty were applications for renewal of product authorisations. In those circumstances PCO sought leave to apply for mandamus by way of an application for judicial review directing the Board to determine forthwith the outstanding applications and, further, a mandamus by way of application for judicial review directing the Board to provide"an abridged and expedite procedure" for the issue of product authorisations and renewals thereof. The statement grounding the application for judicial review also sought a declaration that the Board was in breach of the duties imposed upon it as Competent Authority. The statement of grounds concluded with two paragraphs under the heading of "Damages" in which PCO complained that the actions or inactions of the Board had prevented them selling medicinal products in the State which were in free circulation in other member states. Leave was granted to the Appellants by order of Geoghegan J made on the 30th November, 1998.

4 On the 12th February, 1999, a statement of opposition was delivered by the Board. The statement was verified by a detailed affidavit sworn by Dr Frank Hallinan, the Chief Executive of the Board. That affidavit, and the numerous documents exhibited therein, analysed the work of the Board and the manner in which it purports to discharge its functions. A further affidavit was sworn by Mr Patrick Wadding on behalf of PCO to which an affidavit in reply was sworn by Dr Hallinan on the 29th October, 1999. By notice of motion dated the 14th day of March,...