PCO Manufacturing Ltd. v. Irish Medicines Board [2001] IESC 46 (22 May 2001)

JUDGMENT OF MR JUSTICE FRANCIS D MURPHY DELIVERED THE 22 ND DAY OF MAY, 2001 (NEM DISS) ________________________________________________________________________ 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, 2000, PCO sought, and, by order of the High Court dated the 20th March, 2000, obtained, leave to amend the statement grounding the application for judicial review so as to include or expand the claim for damages. The amended grounds and the affidavit of Mr Patrick Wadding grounding the application asserted that PCO has suffered a loss of profit in a sum of £635,523 in consequence of the delay of the Board in granting authorisation in respect of sixteen products and failure to grant authorisation in respect of the remaining four. Since the date of that application authorisation has been granted for the remaining four and all of the outstanding applications for renewal have been disposed of. 5. By notice of motion dated the 24th day of March, 2000, PCO applied to the High Court for an order pursuant to Order 39 Rule 9 of the Rules of the Superior Courts directing that the application for judicial review insofar as it related to relief by way of mandamus and declaration should be heard and determined prior to the claim for damages. 6. By a cross-motion dated the 29th day of March, 2000, the Board sought an order directing a plenary hearing of the proceedings herein. 7. By order of the High Court (Kelly J) made on the 4th day of April, 2000, it was ordered that the proceedings herein should stand adjourned to plenary hearing and that the amended statement of grounds as delivered should be treated as the statement of claim and that amended notice of opposition should be treated as the defence. The reasons for making that order and declining to provide for a “split trial” are set out in the judgment of Mr Justice Kelly delivered on the same date. From that judgment and order PCO appeals to this Court. 8. The circumstances in which the Court should separate the issues of liability and damages or any other issues involved in legal proceedings have been considered in a number of cases in this and other jurisdictions. The principle applicable was clearly identified in the judgment of the Court of Appeal of Northern Ireland delivered by Carswell LJ (as he then was) in Millar (a minor) .v. Peeples & Ors [1995] NI 6 (at page 9) when he said:- “Since jury trials became exceptional in personal injury cases, the reasons for keeping an action together in a unitary hearing have been reduced. The Court should in our view take a broad and realistic view of what is just and convenient, which should include the avoidance of unnecessary expense and the need to make effective use of court time. It should in a suitable case be ready to make an order for a split trial. In weighing up what is just and convenient the court should balance the advantages or disadvantages to each party and taking into account the public interest that unnecessary expenditure of time and money in a lengthy hearing should not be incurred.” 9. The application of those principles requires the analysis of the facts of the particular case and the exercise by the Judge concerned of a judicial discretion in relation to the application. In some cases, such as McCabe .v. Ireland & Ors [1999] 4 IR 151 , it is clear that a preliminary issue of law can be identified and determined on an agreed state of facts in such a way as to offer the probability that a substantial saving in costs and time can be achieved. In the present case the substantive issue is whether the Board was guilty of delay and whether, if that was the case, PCO contributed to it. The question of mandamus does not as such arise as no applications are at present outstanding. Whether delay occurred will require an examination of each of the applications made to the Board and how those matters were processed from the date of the application to the date on which they were disposed of. It seems inescapable that this issue would require to be heard on oral evidence with the benefit of discovery and perhaps other interlocutory procedures. If PCO succeed on the first issue the assessment of damages would almost certainly involve recalling at least some of the witnesses who had given evidence of the earlier issue. I am by no means confident that splitting the issues would offer any significant advantages to either party or reduce the demands on judicial time. 10. Mr Justice Kelly having had the opportunity of considering the clear and comprehensive documentation opened to him and the benefit of helpful argument by Counsel declined to order separate hearings of the issue already identified. In my view this was a proper exercise of his discretion with which this Court should not lightly review. In the matter of the Companies Act 1963-1990 and In the Matter of Comet Food Machinery Company Limited [1999] 1 IR 485 Keane J (as he then was) pointed out (at page 490):- “Since the decision of this Court In bonis Morelli: Vella .v. Morelli [1968] IR 11 it has been the law that this court is not fettered by the principles and practice which previously applied to appeals against discretionary orders. However, as was made clear in that case, the court should continue to give great weight to the views of the trial judge and should also have regard to whether the order of the trial judge was in accordance with established principles. It is clear from his judgment in the present case that the learned President had adverted to the principles of law upon which counsel for the respondents relies and, indeed, had approached the case on the basis that it was only in unusual circumstances that the relief being sought should be granted. In those circumstances, I am satisfied that this was a case in which the High Court was entitled to exercise its discretion in favour of the applicant by making the order sought and that this court should not interfere with the exercise by the learned President of his discretion.” 11. Indeed it is notable that the Lord Chief Justice of Northern Ireland made a similar - but not identical - observation in Millar .v. Peeples (above at page 12) when he said:- “.... We think it important that it should be clearly understood that we do not in this court lightly overrule decisions of judges at first instance on matters within their discretion.” 12. The other issue raised by the notice of appeal was whether the learned trial Judge had jurisdiction to direct that the matter should stand adjourned to plenary hearing. It is true that this procedure is not expressly authorised by the Rules of the Superior Courts. On the other hand it is beyond doubt that Mr Justice Geoghegan in granting leave to institute proceedings could have directed at that stage that the matter proceed by way of plenary summons rather than notice of motion. In one sense it might be said that an order made on an ex parte application is provisional upon or at any rate, subject to, the order to be made when the Court has the opportunity of hearing the other party or parties affected by it. I am fully satisfied that a Judge dealing with such an application has an implicit or inherent power to make or amend an order as to how the proceedings should be disposed of when he has had the opportunity of hearing the parties and assessing more accurately the nature of the issues involved. It is beyond doubt that the issues in the present case require oral evidence to be given and that the witnesses be subject to cross-examination. Having regard to the complexities of the issues it seems to me unlikely that this could be achieved merely by cross-examining those witnesses by whom affidavits are sworn. In fact Counsel for each of the parties in their submissions before this Court agreed that a plenary hearing- if available at law - would be the appropriate means of conducting the proceedings. 13. In the circumstances I would dismiss the appeal and affirm the order of the learned High Court Judge. I would recognise, however, that at a later stage in the proceedings distinguished Counsel may, with the approval of the trial Judge, agree a procedure which would facilitate the determination of the principal issue and perhaps a representative sample of such other issues as may be appropriate. BAILII: Copyright Policy | Disclaimers | Privacy Policy | Feedback | Donate to BAILII