HC227 Norbrook Laboratories Ltd. v. Irish Medicines Board [2001] IEHC 227 (21 December 2001)

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URL: http://www.bailii.org/ie/cases/IEHC/2001/227.html
Cite as: [2001] IEHC 227

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    THE HIGH COURT
    703JR/2001
    NORBROOK LABORATORIES LIMITED
    APPLICANT
    v.
    IRISH MEDICINES BOARD
    RESPONDENT
    JUDGEMENT DELIVERED BY JUSTICE KELLY IN AN APPLICATION BY THE IRISH MEDICINES BOARD, IN DUBLIN, ON FRIDAY, DECEMBER 21, 2001.

    MR. JUSTICE KELLY: The Applicant on this application, which is the Respondent in the Judicial Review proceedings, is the Irish Medicines Board. The Irish Medicines Board was set up pursuant to the provisions of the Irish Medicines Board Act of 1995. The principal functions of the Board are set forth at Section 4 of that act. In particular, under Section 4(a), the Board is required to be the regulator in respect of the licensing, manufacture, preparation, importation, distribution and sale of medicinal products. Under subparagraph (f) of subsection {1) of Section 4, it is required to establish and administer a service for obtaining and assessing information as regards the safety, quality and efficacy of medicinal products; and under subparagraph (i), to arrange for the collection and dissemination of information relating to medicinal products, including, in particular, information concerning the pharmacological classification and therapeutic efficacy of such products.

    The Respondent to this application, and the Applicant in the Judicial Review proceedings, is the manufacturer of veterinary pharmaceutical products. It is incorporated and carries on its business at Newry, Northern Ireland, in the United Kingdom. On the 3rd of October of this year, the Irish Medicines Board made a decision to suspend the Applicant's marketing authorisation for a product called Norocillin LA, and that decision was allegedly made pursuant to the provisions of Article 36 of Council Directive 81/851 EEC and Regulation of the Animal Regulations of 1996.

    Norocillin is a long-acting penicillin antibiotic and, when administered, leaves a residue in the animal. If such an animal is slaughtered and enters the food-chain whilst there is a residue of the antibiotic to be found above a certain level, then in such circumstances the Medicines Board considers that there is a public health risk involved. That risk is present in a particular way in respect of persons who have a sensitivity to or allergy in respect of penicillin, and, in such cases, there is a fear of an .anaphylactic reaction in such persons.

    Norocillin Long-Acting has been on the market in this jurisdiction for many years. It was first authorised to be used in the State in 1987, and its last renewal from the Medicines Board took place on the 12th of May, 2000, with a period of five years being permitted, backdated to the 1st of October of 1997; consequently, the authorisation is due to expire in October of next year.

    The decision taken by the Respondent board, the Medicines Board, after giving the Applicant in the Judicial Review proceedings an opportunity to make written submissions, arose in circumstances where studies demonstrated that residues of penicillin in tissues of animals treated with product such as Norocillin LA were above the maximum residue limit at the end of the appropriate withdrawal period. That was the basis upon which the decision which is sought to be impugned in these proceedings came about.

    Norbrook obtained leave from Mr. Justice O'Neill on the 22nd of October of this year to seek a Judicial Review of the decision of the Medicines Board, and the principal relief which is sought in those proceedings is an order of certiorari. Mr. Justice O'Neill granted leave for Norbrook to seek such relief, but he also made an Order that the decision of the Irish Medicines Board be stayed until the determination of the Judicial Review proceedings. However, he built into his Order liberty to apply to the Court with a view to seeking to have that stay discharged on an appropriate period of notice being given. The Medicines Board has availed itself of that liberty, and I heard the application which seeks to remove the stay imposed by the Order of Mr. Justice O'Neill, the day before yesterday.

    It is clear that the effect of the stay granted by Mr. Justice O'Neill has the result of Norbrook being permitted to market their product, notwithstanding the view of the statutory regulator that it should be suspended on public health grounds.

    The Medicines Board in this application contends that there is no jurisdiction vested in the Court to grant a stay of the type which was granted by Mr. Justice O'Neill. The jurisdiction to grant a stay is found in the provisions of order 84 rule 20 subrule 7 of the Rules of the Superior Courts, and that rule is in the following terms, and I quote: "Where leave to apply for Judicial Review is granted, then, (a) if the relief sought is an order of prohibition or certiorari and the court so directs, the grant shall operate as a stay of the proceedings to which the application relates until the determination of the application or until the court otherwise orders." And subparagraph (b) provides, and I quote: "If any other relief is sought, the court may at any time grant in the proceedings such interim relief as could be granted in an

    action begun by plenary summons."

    It is clear that, under subparagraph (a), reference is made to a stay of proceedings, and the argument of the Medicines Board is that the stay here relates to a decision and not to proceedings and, consequently, there is no jurisdiction to have a stay of the type imposed here.

    This application has had to be considered by me as a matter of considerable urgency, and I have not had the opportunity to form a definitive view on whether this point made by the Medicines Board is valid or not. However, I would have to say that I think that the approach of the Court of Appeal in the case of Regina v. Secretary of State for Education, ex parte, Avon County Council, has much to recommend it. The Court of Appeal in England adopted a broad approach and gave a wide meaning to the term "proceedings" in the equivalent English rule. It is not, however, necessary for me to decide this issue on this urgent application. I am prepared, for the sake of argument, to adopt the approach which is urged upon me by Norbrook to the effect that the term "proceedings" is wide enough to cover the decision of the Irish Medicines Board here.

    In any event, it seems to me that little turns on this point because even if there is not a jurisdiction to grant a stay under subparagraph (a), there is undoubtedly a

    jurisdiction to grant an injunction under subparagraph (b). Having regard to the recent decision of the Supreme Court in the case of McDonnell v. Brady and others, it would appear that the principles to be applied in deciding whether to lift a stay or dissolve an injunction are the same. I quote from the judgement of Chief Justice Keane in that case where he said: "While the learned High Court judge took the view that the onus was on the Respondents to satisfy the court in the light of the criteria laid down in American Cyanamid v. Ethicon, including the balance of convenience that the stay granted should be discharged, it could be plausibly contended that, on the contrary, the onus rests on the Applicant to satisfy the court, where it is challenged, that it should be kept in place. There is nothing in the wording of order 84 rule 27(a) to suggest that where an Applicant for leave seeks an order of prohibition or certiorari, he is further entitled ex debito justitae to a direction that the proceedings should be stayed. There seems no reason in logic why the Applicant or the grant of the stay if substantially challenged should not be under an onus to satisfy the court that it is an appropriate case in which to grant such a stay." That seems to me to provide support for the notion that the principles applicable in respect of the lifting of a stay are the same as those which relate to the dissolution of an injunction.

    Consequently, I can then turn to the issue that has to be addressed on this application; namely, where does the balance of convenience lie on this application by the Medicines Board?

    On the one hand, I have the statutory regulator, the Board, which has responsibility for health protection, asserting that there is a danger to public health if this product remains on the market. Norbrook, for its part, says that this is not correct and that the whole approach of the Medicines Board and the way in which it went about its task is wrong. In this application, I am, of course, only concerned with the question of the lifting of the stay or not. I do not wish to comment on nor do I wish any of my observations to be regarded as an indication of my views concerning the merits of the case. In fact, I do not have any such views in circumstances where I have not been, and could not have become, involved in the lengthy factual and legal disputes which remain to be dealt with by the trial judge.

    Norbrook's assertion that the Irish Medicines Board is wrong in the decision which it has reached, means, also, it seems to me, that so, also, is the equivalent authority in the United Kingdom. For in that jurisdiction, the product is, in fact, suspended, and has been so since June of 2000. In the United Kingdom legislation, there is a formal appeals procedure and that appeals procedure has been invoked by Norbrook. There is no formal statutory appeals procedure in this jurisdiction. But in the United Kingdom, despite the fact that an advisory committee has rendered advice to the regulator, in a manner favourable to Norbrook at the first stage of the appeal, nonetheless the statutory regulator there has maintained the suspension. The matter in the United Kingdom is now at the second stage of appeal. But in the meantime, on the merits, apparently, the regulator has maintained the suspension. So if it is said that the regulator in this jurisdiction is wrong on the merits, then similar criticism can be made of the United Kingdom regulator which has maintained its suspension notwithstanding the invocation of the first tier of the appeals procedure in that jurisdiction.

    The situation which obtains in the United Kingdom, which, after all, is Norbrook's principal place of business, is, in my view, powerful evidence against it on this application, and I say that for two reasons. First, the continuation of the stay in these proceedings would mean that a judge of this court - myself in this case - would, without any of the professional expertise available to either of the regulators, either in this jurisdiction or in the United Kingdom, be allowing a product back onto the market where it has been suspended not merely in this country but also in the United Kingdom, and where it remains so despite an appeal which has been made there and where the first tier of such appeal has been exhausted.

    Secondly, it seems to me that the position in the United Kingdom empties Norbrook's case concerning loss of reputation of much of its force. Its product has been off the market for well over a year in its home country, and it is, therefore, difficult to see that there is much force in the loss of reputation argument which is made concerning the product in this jurisdiction. In addition, the loss of profits which will be sustained as a result of the suspension have been quantified at £81,700, and there is no reason to believe that, if successful in these proceedings, the Medicines Board would not be in a position to pay that sum if it were awarded to Norbrook.

    Furthermore, it seems to me that this is not a case where the gap in the market which is created by the existence of the suspension is being filled by a competitor, because all of the competitors to Norbrook likewise have their authorisations suspended.

    In coming to the conclusion which I do on this application, I have, of course, given weight to the fact that the product is not suspended in certain other European States, and I take that into account. But I confess that I know little of the regulatory regimes which are in place in those jurisdictions.

    The involvement of another European body, which was put before me and expanded upon by Mr. O'Reilly in his submission, which body is expected to make a decision in a definitive way in about five months' time (if that time estimate is accurate) seems to me to weigh against rather than in favour of Norbrook's application. If Norbrook's contention is correct and this body gives a decision which will be definitive and determinative of these issues within a period of five months, then this Judicial Review will be rendered otiose and in a much shorter period than it would take in order to bring it on for full hearing.

    So in these circumstances, it seems to me that the concerns expressed by the Medicines Board concerning the public safety element of this medication have not been outweighed on the balance of convenience by the assertion made by Norocillin's manufacturer, Norbrook, the Applicant in these Judicial Review proceedings, concerning either loss of reputation or other damage which might be suffered by it. On the balance of convenience, I take the view that between now and the deterraination of these proceedings, the stay imposed by Mr. Justice O'Neill should be discharged. That will restore the status quo ante to what it was when the suspension which was made by the Medicines Board on the 3rd of October, 2001, came into place.

    So the application of the Medicines Board succeeds. The stay is discharged and, consequently, the suspension on the marketing authorisation continues in force as it was between the 3rd of October and the grant of leave by Mr. Justice O'Neill.

    MR. O'REILLY: May it please the Court.

    MR. JUSTICE KELLY: What I propose to do is this: I propose to make the Order as I have pronounced it, but there will be liberty to apply in respect of it because if this other European entity gives the determinative decision, which will be binding, then of course there is leave to apply not merely to deal with any question of a stay but also to deal with the substantive proceedings. So the stay will continue pending the determination of these proceedings or until further Order of the Court, with liberty to apply to both parties.

    MR. McDONALD: In relation to the costs of this application, this is obviously being treated in a similar way to an application for an interlocutory injunction or application to discharge an interim injunction. I am not sure that I can press you —

    MR. JUSTICE KELLY: No, I propose to reserve the costs because it seems to me that that is the — approaching the matter as I do, that would be the normal Order. There are exceptional circumstances where a costs order can be made, but it doesn't appear to be that this would be one of those. So Order as pronounced with the costs of this application reserved.

    MR. O'REILLY: May it please Your Lordship.


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