S.C. 226 of 2005

IpsofactoJ.com: International Cases [2010] Part 11 Case 8 [SCIre]


SUPREME COURT OF IRELAND

Coram

Hygeia Chemicals Ltd

- vs -

Irish Medicines Board

GEOGHEGAN J

MACKEN J

 

27 JANUARY 2010


Judgment

Macken J

  1. This is an appeal from the judgment of the High Court (Finnegan, P.) following upon the hearing of a judicial review application which, at the end of the day, proceeded on an amended Statement of Grounds dated the 17th April, 2003; the original application for leave was made on the 20th January, 2003 pursuant to a Statement of Grounds of that date, and grounding affidavits of Eugene McCartan, Managing Director of the appeallant, one of Professor Michael Hynes and one of Declan O’Brien. Leave was granted by Order of the High Court (McKechnie, J.) dated the 22nd January, 2003. In the amended grounds the appellant sought an order of certiorari quashing the decision of the respondent itself dated the 26th February, 2003. The Statement of Grounds, as amended, was opposed by an amended Statement of Opposition. Issues were finally agreed between the parties pursuant to an agreed Issue Paper dated in or around July, 2003. The judicial review proceedings took place over several days between the 9th to the 31st July, 2003. The application for judicial review was rejected on all of the grounds, by the above judgment delivered on the 4th May, 2005, save that the learned High Court judge found that the appellants were not estopped from challenging the procedures for the oral hearing adopted by the respondent. There is no appeal by the respondent from that finding.

  2. From that judgment the appellant appealed by Notice of Appeal dated 13th July 2005, which contained 21 separate grounds of appeal. Detailed written submissions were filed on behalf of both parties, which were very helpful, and key documents were extracted from what must have been voluminous files before the learned High Court judge, together with relevant extracts from the transcripts.

  3. At the commencement of the appeal Mr. O’Reilly, senior counsel for the appellant, indicated to the Court that, in reality, several of the grounds of appeal could be combined, or were overlapping, so that there were just three remaining, namely:

    1. The learned High Court judge erred in law in failing to declare that the procedures adopted by the respondent and/or by its Advisory Committee were such that they did not permit the appellant, contrary to the principles of natural and constitutional justice, to have a fair or proper hearing;

    2. A discrete but, to some extent related, claim that the learned High Court judge failed to find that the decisions of the Advisory Committee and the further decision of the respondent itself were tainted by bias. The bias alleged covers both subjective bias on the part of a named individual, and objective bias;

    3. The learned trial judge had adopted an incorrect test in law, because in the event that the “precautionary principle” was to be applied to the withdrawal or cancellation of the appellant’s licences, which he held to be the case, this principle requires, pursuant to Community Law, the adoption and application of specific procedures, and these were not either adopted or applied.

    The Respondent

  4. The respondent was established by the Irish Medicines Board Act, 1995 (“the Act of 1995”) and is, in effect, the successor to the National Drugs Advisory Board, established in turn under the Health (Corporate Bodies) Act, 1961. The Act of 1995, inter alia, implemented the provisions of certain European Community Directives The main relevant functions of the Board are set out under s.4 of the Act and can briefly be enumerated:

    • It is the competent authority in the State for the purposes of Council Directive 65/65/EEC of 26th January, 1965, as amended, and by Council Directive No. 81/851/EEC of 28th September, 1981;

    • It exercises the powers conferred on the supervisory body by Council Regulation No. 2309/93 of 22nd July, 1993;

    • It has powers under the Health Act, 1947 and the Control of Clinical Trials Act, 1987 and 1990 to make certain regulations;

    • It exercises all the other functions listed in s.4 of the Act of 1995;

    • In addition it has a specific function to obtain, assess and monitor information concerning the safety, quality and efficacy of all relevant products.

  5. For the purposes of this appeal, its primary functions are the issuing of authorisations or licences and/or variations of the same in respect of all pharmaceutical and/or chemical products sought to be manufactured and/or made available in the State, whether for human use or, in the specific case of this appeal, veterinary use. In respect of the same it may also regulate and control, inter alia, the presentation of such products in the market place, and their containers, labelling, packaging and instructions for use or inserts published in respect of the same.

  6. Under the provisions of s.9 of the Act of 1995 the Minister was obliged to, and did, appoint, as one of two committees, a committee to be known as the Advisory Committee for Veterinary Medicines (the “ACVM”) to assist and advise the respondent in relation to matters pertaining to the safety, quality or efficacy of medicinal products for animal use referred to it, and to perform the functions assigned to it by s.9(8). Under s.9(5) of the Act, a Committee (of the Board of the respondent) “shall regulate, by standing orders or otherwise, the procedures and business of the ACVM”. Under the provisions of s.(7) and s.(9) of the Act, of relevance to one of the issues in this appeal, the chairperson of the ACVM must be a member of the Board of the respondent.

    Factual Background

  7. The appellant, together with other chemical companies, are the manufacturers or producers in the State of products for veterinary use. Two of the appellant’s products are sold under the trademarks or brand names Hygeia Winter Dip and Hygeia Summer Dip. They are used as anthelmintics in the treatment of worm infestations found in sheep. In respect of these two products, authorisations were granted by the respondent, as the competent authority, on the 1st October, 1999 and a variation was granted on the 14th March, 2001 pursuant to an application in that regard made by the appellant. At the relevant dates of the decisions the subject of this appeal, valid authorisations for the sale of the appellant’s products existed. These products, as do competitor products, contain liquid organo phosphate. In the judgment and throughout the hearing on appeal this is referred to as OP. The appellant’s products, at least at the relevant period, contained 10% diazinon, an OP, and were sold in plastic containers. In order to use the appellant’s product, the container is opened by the user and the product then poured into a sheep dip bath.

  8. Concerns have been raised over the years that exposure to OP has or may have an adverse effect on human health. The trial judge found, correctly in my view, that “the reports referred to in the course of this hearing are not fully conclusive as to the effects of OP”. It is common case between the parties that the report of the Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment made in November, 1999 (“the COT Report”) mentions these concerns in two respects, namely, adverse health effects arising from either acute poisoning or from prolonged low level exposure. Sometime prior to 2000, the respondent requested the Liaison Committee on organo phosphate veterinary concentrates to the ACVM, inter alia, to review the COT report and other relevant reports and scientific articles in relation to OP concentrate solutions intended for veterinary use, and to evaluate what changes, if any, were necessary to OP concentrates insofar as concerns, among other things, containers in which they are sold. That committee reported on the 21st March, 2000 and, as to containers, stated:-

    The committee noted that current containers meet the current requirements under the Carriage of Dangerous Goods by Road (Regulations) 1999 as drafted for transport of dangerous liquids. The committee noted that considerable variation existed in the type and size of containers marketed in Ireland. However, no uniform standard for design specifications of OP concentrate containers for veterinary use appear to be available.

    The Liaison Committee, having set out its views in relation to the question of containers, included the following among its recommendations:-

    That the containers in which OP concentrates are supplied for veterinary use be kept under review by the Irish Medicines Board in the light of national and international developments and that all authorised products should comply with any new standards.

    [emphasis added]

  9. It appears from the judgment that the ACVM endorsed this report on the 15th March, 2001.

  10. The difficulties which generated the present proceedings arose in the context of the following series of steps taken by the respondent in relation to the appellant’s two products:-

    (a)

  11. On the 19th November, 2001 the respondent wrote to the appellant in the following terms:-

    The I.M.B. is aware that new standards in delivery systems have been developed or are currently under development by a number of relevant companies. This issue was discussed at a recent meeting of the Veterinary Advisory Committee who concluded that, for all relevant products on the Irish market, new closed delivery systems or similar, aimed at reducing operator exposure to the concentrate must be in place before 31st October, 2002 and any product not in compliance with the new standard at that date should be recalled from the market”.

    [emphasis added]

  12. The underlined portions of this letter are of particular relevance in the appeal.

    (b)

  13. Two suppliers to the Irish market, each of whose products contain 60% diazinon, had apparently developed or were developing closed delivery systems. No suggestion was made in the letter that any national or international standard had been adopted and none has since been claimed to exist. The appellant had, at a much earlier date, changed its original container (made of tinplate) to a plastic container to avoid, according to the evidence, “welling” of the liquid concentrate during opening, pouring, operation or use.

    (c)

  14. On the 16th July, 2002 the appellant responded to that letter and enclosed a report which it had commissioned from a company called Willis Corroon Hinton (Ireland) Limited, referred to in the judgment as the “Willis Report”. This contained a hazard identification and risk assessment of all three products then on the Irish market, and included, inter alia, the following note concerning the appellant’s container:-

    4.2

    Irish Medicines Board Requirements

    The only guidelines available in Ireland regarding proper OP sheep dip presentation design are contained in the Irish Medicine Board’s report to the Veterinary Advisory Committee (2000). This proposes the following desirable attributes for such containers:

    Durable to survive handling, storage and transport from the manufacturer through to farmer;

    Capable of being opened while wearing the recommended gloves;

    Where a handle is provided, it should be offset from the spout, to minimise operator contact with the handle for presentations of greater than one litre;

    Have a wide spout to avoid glugging; and

    Have a spout which would extend and not allow the fluid to dribble and pool on the top surface.

  15. In addition it was stated that:

    A closed system of delivery was considered by the Committee as an alternative, but it was acknowledged that there were many practical problems associated with this option. It was noted that there is no generically available system. Many of the simpler closed systems would lead to exposure to the operator at the point of setting up or dismantling or would not give the necessary control for the performance needed or would have a potential for misuse.

  16. The Willis Report also identified risks associated with the two closed system products and concluded that “only the Hygeia product clearly meets the I.M.B. requirements, that is, the recommendations of the Liaison Committee”

    (d)

  17. On the 19th August, 2002 the respondent, having reminded the appellant of the meeting of the ACVM in October, 2001 and the content of the decision of that committee notified by letter of the 19th November, 2001, wrote to the appellant, inter alia, in the following terms:-

    As a follow up to that letter, and notwithstanding the fact that an appeal to (sic) the decision detailed above will be considered at the September meeting of the ACVM, I am writing to ascertain the stocks of Summer Dip and Winter Dip remaining on the market at this point in time. Further, in the event that your appeal to the ACVM is not successful you are requested to confirm that no product in the open system will be introduced to the Irish marketplace after the 31st October deadline. As indicated previously, any product in delivery systems not acceptable to the IMB and remaining on the marketplace after 31st October should be recalled.

    (e)

  18. Further regular and detailed exchanges occurred from the 6th September, 2002, with the October, 2002 deadline being maintained in place by the respondent, and a clear disagreement being evident between the parties, on what would next occur and/or by what process or procedure. In particular the appellant queried, as early as the 6th September, 2002, the approach to an “appeal” adopted by the respondent.

    (f)

  19. A further decision of the ACVM was notified by letter of 21st November, 2002 confirming its position and indicating an appeal would take place on the 18th December, 2002.

    (g)

  20. Because the position as to the applicable procedures was still unclear, on the 10th December, 2002 solicitors acting on behalf of the appellant wrote to the respondent setting out the history of the exchanges which took place. This lengthy letter contains a synopsis of the entire of the lengthy exchange of correspondence between the parties and sets out the difficulties which the appellant contended they were facing at the time. This letter is very comprehensive but the following is the introduction and a synopsis of the matters covered in it:

    We are instructed in this matter by Hygeia Chemicals Limited.

    We refer to previous correspondence herein in particular your letter of the 21st November 2002 to our clients. This notified our clients of the decision of the

    Advisory Committee for Veterinary Medicines (ACVM) to suspend the veterinary product authorisations for Hygeia Summer Dip and Hygeia Winter Dip and its decision that only approved closed delivery systems for transferring organophosphates from the container to the dip bath are acceptable for the protection of public health. Our clients have valid marketing authorisations for a five year period from the 1st October 1999.

    Our clients have appealed that decision to the Advisory Committee for Veterinary Medicines as referred to in your correspondence and their letter of 26th November last.

    Your letter also described the procedures for an appeal before the ACVM. As you are aware our client’s letter dated 26th November also raised a number of queries concerning the details of the appeal.

    We refer to your letter of the 27th November, 2002 further dealing with the procedures described. Regrettably, we are not satisfied with many aspects of the appeal procedures described in your letters of 21st and 27th November last.

    So there is no misunderstanding between you and our clients before any appeal takes place we reply to your recent correspondence on behalf of our clients as follows:-

    The letter then sought the following arguments, setting out reasons for doing so:

    I.

    Copy of Rules for appeals before Advisory Committee for Veterinary Medicines

    II.

    Copy of risk assessment carried out by the Advisory Committee for Veterinary Medicines

    III.

    Copy of study on solubility of sachets containing diazinon for use as a sheep dip

    The letter also listed the following matters of complaint:

    IV.

    Appeal taking place before the same Advisory Committee for Veterinary Medicines as dealt with the original material, and seeking a differently constituted Committee.

    V.

    Unacceptable limitations on the right of appeal

    VII.

    Too short time provided to consider documents for purposes of the appeal and prepare responses ....

    It continued:

    Our clients are both concerned and unhappy about the appeal procedures described in your correspondence. This concern is heightened when our clients have not been supplied with any appeal procedure or rules adopted by the Irish Medicines Board. For this reason it is under protest that Hygeia participates in the appeals procedure. Please further note that our client does so without prejudice to all other avenues and remedies available to it.

    From the information presented we are satisfied that our client has and continues to be treated in a totally unacceptable and unfair manner and for this reason we have been instructed to take all necessary steps in order to protect our client’s position ....

    (h)

  21. This letter was replied to by the respondent on 13th December, 2002 and it is appropriate to set out the relevant parts of that letter as follows:

    I acknowledge receipt of your letter of December 9th which I have only just received having been away at the European Medicines Evaluation Agency, London on business until today. I note that my letter of November 27th to your client has described the procedures for an appeal before the Advisory Committee for Veterinary Medicines (ACVM), but as requested in your letter, I am happy to provide additional clarification for you on this point for the avoidance of any doubt.

    This letter then set out in some detail the procedure for appeal proposed for the ACVM on the 18th December, 2002. It also covered the following issues:

    Risk Assessment carried out by the ACVM

    Solubility of sachets marketed by Competitor Company

    Appeal before ACVM specially appointed

    Limitations on the appeal

  22. Summary closing statements.

    In essence these responses rejected the complaints made on behalf of the appellant.

    (i)

  23. That letter was replied to on the 17th December, 2002, one day prior to the appeal, by solicitors on behalf of the appellant. In light of the closeness of this date to the appeal, I do not think it necessary to set it out. Basically it repeated several of the matters in the original letter which the solicitor had written, including, in particular, (a) a request for a copy of the rules or regulations which govern such appeals, (b) a request for a copy of the original risk assessment of the ACVM, (c) a request for a differently constituted Advisory Committee than that which made the original decision, (d) a complaint about unacceptable limitations on the right of appeal, including limits on time and personnel, and (e) a claim to a right to fair procedures in the appeal before the ACVM, including an entitlement to deal with the merits of the appeal.

  24. Finally the letter concluded:

    The submission of our client to this appeal process is not to be taken as an acceptance on their part of the lawfulness or otherwise of the matters complained of in this correspondence.

    (j)

  25. After the appeal procedure took place, the results were notified to the appellant by letter dated the 19th December, 2002. This is also an important letter and because of its length is exhibited as “A” to this judgment. It rejected the appeal in full.

  26. These proceedings were commenced the following day on the 20th December, 2002, and as mentioned above, judgment was delivered on 4th May, 2005.

    The Appeal

  27. I propose to deal with the grounds being maintained on this appeal in the following order:

    1. The unfair procedures ground;

    2. The bias ground;

    3. The precautionary principle ground.

    A. The Unfair Procedures Ground

  28. This ground is related somewhat to the bias ground but stands separately and has several strands to it. In the original application before the High Court the appellant sought a declaration that the respondent had failed to comply with the principles of basic fairness of procedures and natural and constitutional justice as required by the Constitution, in the internal procedures adopted for the review of veterinary product authorisations subsequent to their grant, and in respect of appeals from any such reviews.

  29. In his judgment the learned High Court judge found that, while the requirements of natural justice vary with the nature of the enquiry concerned, the procedures actually adopted were “appropriate and sufficient”. In the Notice of Appeal this ground of appeal is dealt with in the following terms:

    (6)

    That the learned President of the High Court erred in law and in fact in failing to find that the internal procedures adopted by the respondent failed to comply with the principles of natural and constitutional justice and basic fairness of procedures on any of the grounds identified at paragraph 47 of the Statement of Grounds; or in breach of the principles stated in paragraph 49 (being the principle of proportionality and respect for fundamental rights including the rights of property, the principle of legal certainty, protection of legitimate expectations and the principle of equality).

    (19)

    That the learned President of the High Court erred in law and in fact in failing to hold that the respondent’s decision breached the principles of natural and constitutional justice and basic fairness of procedures. At all material times in respect of the respondent’s procedures the applicant was required to furnish the respondent with exhaustive details of the documents, experts and reports on which reliance was placed (including the two lever arch files of documents and outline submissions requested in advance under a restricted time limit and prepared for the appeal before the ACVM). In contrast the respondent concealed the authorship of the Risk Analysis carried out on the appellant’s products by the respondent’s Veterinary Director; the criticism made of this Risk Analysis by the respondent’s rapporteur appointed for the purposes of the ACVM appeal; the manner in which the respondent’s Veterinary Director carried out an ad hoc and improvised “toilet test” as a “pouring study” to determine whether there was dripping down the side of the appellant’s containers; the dismissive opinion which the appellant’s Veterinary Director had of the said pouring studies; and the concealment from the ACVM and from the Irish Medicines Board of the manner in which the said “test” had been carried out.

    (20)

    That the learned President of the High Court erred in law and in fact in failing to find a breach of natural and constitutional justice and basic fairness of procedures in the manner in which the rapporteur appointed to review the evidence before the ACVM reviewed the documents and papers including the respondent’s risk analysis and only put points that were unfavourable to the applicant/appellant and did not bring to the appellant’s notice favourable observations of the said rapporteur and criticisms made of the risk analysis and the literature relied upon therein which were favourable to the appellant and questioning and critical of aspects of the respondent’s Risk Analysis.

    (21)

    That the learned High Court judge erred in law and in fact in holding that the consideration of “similar systems of delivery to close systems” is irrelevant. The respondent’s correspondence to the appellant dated the 19th November, 2001 referred to “.... new closed delivery systems, or similar, aimed at reducing operator exposure to the concentrate ....” The respondent concealed from the appellant the decision of the ACVM made at its meeting on or about 3rd October, 2001 to interpret the above description as requiring the appellant to meet what it described as a closed and not an open system of delivery. By failing to notify the appellant of its earlier decision prior to the appeal before the ACVM on the 18th December, 2002, the respondent acted in breach of the principles of basic fairness of procedure and natural and constitutional justice.

  30. Paragraph 47 of the amended Statement of Claim is in lengthy terms. In addition, Ground 47 is repeated, by the provisions of Ground 60 in respect of the respondent’s own decisions dated the 26th February, 2003. It is sufficient to set out Ground 47:

    The internal procedures adopted by the respondent under the Irish Medicines Board Act in respect of the review of the veterinary product authorisation failed to comply with the principles of natural and constitutional justice and basic fairness of procedures ....

    (i)

    There are no formal written procedures (whether by way of regulations, standing orders or otherwise) describing the manner in which the respondent’s Advisory Committee for Veterinary Medicines conducts appeals.

    (ii)

    The review is considered initially by the respondent’s Advisory Committee for Veterinary Medicines.

    (iii)

    The appeal from the initial decision of the respondent (through its Advisory Committee for Veterinary Medicines) is to the said Advisory Committee for Veterinary Medicines.

    (iv)

    The appellant procedures constitutes the respondent (through its Advisory Committee for Veterinary Medicines a judge in its own cause and fails to respect the nemo iudex in causa sua principle.

    (v)

    The entire procedure is opaque and appears to be conducted on an ad hoc basis according to whatever rules the respondent’s Veterinary Director lays down.

    (vi)

    The absence of published and transparent procedures for applications and appeals before the Advisory Committee for Veterinary Medicines of the respondent makes the respondent a judge in its own cause in which it also acts as the presenting or prosecuting authority and participates in the deliberations of the said Advisory Committee for Veterinary Medicines.

    (vii)

    Requiring the applicant in its written documents and appeal to produce independent evidence and experts in its appeal while allowing the respondent to rely upon limited written reports or extracts from scientific literature with no opportunity to verify or question assertions made.

    (viii)

    Adopting a procedure for appeals before the Advisory Committee for Veterinary Medicines which encompassed prejudgment on the part of the respondent.

    (ix)

    Relying on anonymous, unsigned and un-paginated risk assessment.

    (x)

    Acting ultra vires its powers as outlined in Paragraph 37 and 38 [of the amended Grounds for Leave].

  31. The Issue Paper retained the ground of unfair procedures.

    Preliminary

  32. Before dealing with this specific ground of appeal, it is necessary to say something about the licensing of medicinal products in order to place the complaints in context. Pharmaceutical and/or chemical products for veterinary use, as in the case of pharmaceutical products for human use, are clearly very valuable to their owners. Where it is not possible to market such products without a licence or authorisation, as is the case under Community Law and in almost all countries throughout the world, the product as authorised may be extremely valuable indeed, and without an authorisation will be of little or no value at all. The securing of such a licence or authorisation, governed as it is by Community Law, may be a difficult, protracted, and expensive undertaking. To deprive the owner of such an authorisation or licence to sell a product or to withdraw a product, as authorised, from the market are very clear restraints on property rights. These property rights can in law be restricted, and an authorisation withdrawn or cancelled or the product withdrawn from the market, and the owner can be deprived of his rights, but only for valid reasons, for example, in the interests of the common good. Frequently this common good relates to the health of humans, because adverse side effects of a serious, or even fatal, nature have been disclosed. The same applies, in principle, to veterinary products, which may have side effects of an adverse nature, both to animals and even to humans using the products in question. Regulation 19 of the Animal Remedies Regulations, 1996 (S.I. 179 of 1996), makes the respondent the competent authority for the purposes of Council Directive 2001/82/EC which relates to veterinary products. Directive 2001/82/EC provides at Article 83.1, the following:

    1.

    The Competent Authorities of the Member States shall suspend or withdraw marketing authorisation when it is clear that

    (a)

    the veterinary medicinal product proves to be harmful under the conditions of use stated at the time of application for authorisation or subsequently.

  33. Where it is considered necessary to review the presence of products on the market and/or withdraw an authorisation, thereby possibly depriving a party of a valuable property right, it is clear from the case law of our courts that established principles of law apply so as to ensure the appropriate respect for Constitutional rights attaching to the diminution or cancellation of the property rights in question. These include principles applicable to the process or the procedures operating to deprive a person of such rights or interests, which procedures must be fair in law. No relevant case law on this point was cited in the judgment, and I do not consider it necessary to do so in my judgment, since the principle is such a well established and fundamental one.

    The “Appeal” Process

  34. The present appeal under the unfair procedures ground rests on the proposition that the learned trial judge erred in law in his approach to the issue of fair procedures and in the legal conclusions he reached. As to the allegation of unfairness based on the nature of the review processes adopted by the respondent and its internal committee, there are several complaints in that regard. I propose to deal only with a sample range of those raised by the appellant.

  35. The first is that, while there were no standing orders or rules regarding the same, an appeal process was established by the respondent in respect of the withdrawal of the appellant’s products. The process, it is said, was dealt with on an ad hoc basis which was entirely opaque and lacking in transparency and legal procedural certainty, contrary, in particular, to Community Law. Mr. McCullough, senior counsel for the respondent, submits that provided the process in fact operated adequately, and he submits that the learned High Court judge was correct in finding that they did, there can be no legitimate complaint by the appellant in respect of the absence of by-laws. As a general statement of the law, I accept that is correct. I do not agree, however, that this was the position in the context of the present case. The legislation requires the respondent to regulate “by standing order or otherwise” its procedures. This is obviously with the intention that there will be in place rules relating to whatever processes are adopted by the respondent in the regulation and operation of its various functions, and that such standing orders, however described, are readily available to persons invoking or becoming part of the processes established or made available by the respondent. Particular difficulties arose in the present case because neither the appellant nor its legal advisors were in a position to discover, at a reasonable time prior to the appeal, precisely how such appeal procedure, adopted by the respondent, would operate. Further, difficulties arose in relation to discovering what precisely was being appealed. Was it a decision to withdraw the products, or a request to do so or was it a cancellation or suspension of product authorisations? All three phrases were used variously throughout the correspondence, as if they were the same, which quite clearly is not the case.

  36. Notwithstanding the absence of standing orders, a so called “appeal” process was nevertheless put in place by the respondent. All the relevant letters addressed to the appellant in relation to the process referred to a “decision of the ACVM” and to an “appeal” from that decision to the ACVM itself. It is said by Mr. McCullough, for the respondent, that the appellant knew at all material times, and before the commencement of these proceedings, that the relevant legislation only permitted the respondent itself to make decisions as to the withdrawal of any product from the market, or for the cancellation of any product authorisation. To the extent that the appellant was alert to this very shortly prior to the commencement of these proceedings, this is evidenced by the correspondence from the appellant’s solicitors in mid December, 2002. However, this is not the real point in contention. The point in issue is that the respondent itself set up, within an opaque review process, a decision making procedure by the ACVM, including within that process an “appeal” from that decision, and to which the appellant became a party. There was, however, in respect of this, no template and no set of rules. In the High Court this process was described by the learned High Court judge as a “review” process with a preliminary indication of the approach of the ACVM, an opportunity being afforded to the appellant to be heard, and to persuade the ACVM to adopt a different approach. In the course of the submissions and/or the argument before this Court it was referred to as having “several phases”.

  37. It seems to me that whatever the particular nomenclature adopted to describe the process in fact adopted by the respondent, that process had a purported appellate stage. However it is described, that process had to be constitutionally fair to parties engaged in it. For the respondent to suggest, as it now does that there is no appeal at all and that the use of the word “appeal” was an error on its part, corrected when it secured legal advice, is disingenuous in the context of what actually occurred. It is sufficient to refer to some of the letters in question. After submissions were made to the respondent by the appellant by letter dated the 16th July, 2002 the respondent replied on the 19th August, 2002 speaking of the “decision” of the 19th November, 2001 of the ACVM, and “that an appeal to the decision detailed above will be considered at the September meeting of the ACVM”. The subsequent letter of the 19th August in its title referred to “Appeal of Decision to Withdraw Winter Dip ....” The letter from the respondent to the appellant dated the 9th September, 2002 again referred in its title to an “appeal” of the decision, indicating that the appeal was from a “decision” of the ACVM taken on the 3rd October, 2001 (notified by letter of the 19th November, 2001). That letter indicated that the ACVM would meet on September 18 and review the information presented by the appellant, and would at that stage decide whether or not to “agree to receive an “appeal” from your company in person”. The subsequent letter of the 20th September, 2002 from the respondent to the appellant stated that the appellant would be given “the opportunity to appeal”. The letter of the 21st November, 2002 invited the appellant to attend before the ACVM “to appeal its decision”. The decision in that case referred to confirmation of the ACVM decision that “approved closed delivery systems” only were acceptable. It is also to be noted that in the long letter of the 19th December, 2002, notifying the appellant of the decision, details of the “appeal hearing” are set out.

  38. The contention that no appeal exists is correct only insofar as a final determination of Board of the respondent is concerned may indeed be correct. But if, within the review process itself leading to a possible determination adverse to the appellant, and having immense potential consequences, the respondent itself sets upon appeal stage or phase within the process as it did in this case, that appellate stage must comply with the law relating to fair procedures.

  39. In light of the foregoing, I am satisfied that the absence of by-laws or other clear rules or regulations by which the mechanism applicable to the review or recall of products or of the withdrawal of an authorisation had as a consequence that unfair procedures were adopted which had a detrimental effect on the ability of the appellant to deal appropriately with the process adopted by the respondent, and that the manner in which the appeal process – subsequently denied to exist on the part of the respondent – operated, did not comply with the requirements of constitutional justice.

    The Standard

  40. A particular difficulty arose in the course of the appeal process concerning the standard which was being applied by the respondent in relation to the appellant’s sheep dip, to the review of its products and/or the withdrawal of those products from the market and/or the withdrawal of its authorisations. The learned High Court judge found that as to standards, there was nothing improper in law in the respondent refusing to give any access to information concerning competitor products on the market, because what was being considered were the appellant’s products. At first glance this is a perfectly acceptable approach and one which in law I do not consider could be criticised. This is because, in general, competitor products and information concerning, in the present case, the particular containers used by competitors and how they perform, are matters which are protected from disclosure to third parties. However, given the particular decision by the respondent in the present case, to adopt a so called “standard” by specific reference to competitor products, I do not consider this was, in law, a correct approach by the learned High Court judge in the present case. It will be recollected that the Liaison Committee in its report to the ACVM on COT, stated:

    A closed system of delivery was considered by the Committee as an alternative, but it was acknowledged that there were many practical problems associated with this option. It was noted that there is no generically available system. Many of the simpler closed systems would lead to exposure to the operator at the point of setting up or dismantling or would not give the necessary control for the performance needed or would have a potential for misuse.

    [emphasis added]

    And the same Committee, in reporting to the ACVM, recommended, as is clear from the respondent’s letter of the 19th November, 2001 to the appellant:

    The containers in which OP concentrates are supplied for veterinary use be kept under review by the IMB in the light of national and international developments and that all authorised products should comply with any new standards.

    [emphasis added]

    The letter of the 19th November, 2001, a key letter leading to the present proceedings, followed on in stating:

    The IMB is aware that new standards in delivery systems have been developed or are currently under development by a number of relevant companies. This issue was discussed at a recent meeting of the Veterinary Advisory Committee who concluded that, for all relevant products on the Irish market, new closed delivery systems, or similar, aimed at reducing operator exposure to the concentrate must be in place before 31st October, 2002 and any product not in compliance with the new standard at that date should be recalled from the market.

    [emphasis added]

  41. Two difficulties in relation to this “standard” became clear during the course of the appeal process and more particularly during the course of the High Court hearing. Firstly, and contrary to the letter of the 19th November, 2001 just cited, the ACVM, had in fact decided at a meeting, which took place as early as the 3rd October, 2001, that the phrase “or similar, aimed at reducing operator exposure to the concentrate” would no longer apply. This key difference in what had been called for by the respondent by letter of the 19th November, 2001 was discovered, for the first time, in the course of the exchange of affidavits in the High Court, where it was said on behalf of the respondent that the letter of the 19th November, 2001 had to be read “in light of” the minutes of a meeting of the 3rd October, 2001 which showed that the ACVM had, in fact, decided that only a “closed system” would be permitted on the market by the date mentioned. As was argued on behalf of the appellant, rightly in my view, this had the effect of ensuring that its products could not comply with the non-disclosed standard being imposed by the respondent, and this alteration was never made known to it even during the appeal process, during which the appellant was being invited to persuade the ACVM – on the respondent’s case – that the appellant met the terms of the letter of the 19th November, 2001.

  42. The second difficulty also concerns the particular “standard” being adopted. In the absence of any international or national standard, which is what an industry would normally expect to comply with, the respondent, and more particularly its ACVM, decided to adopt what it called “new standards in delivery systems .... developed or .... currently under development” which were, in reality, the changed containers being used or in the course of being developed by two competitor companies in the Irish market. I do not think that, in law, any real complaint can be made if, in the absence of a standard at national or international level, a competent authority such as the respondent, adopts a standard which is reflective of developments taking place through the impetus of commercial companies. However, when that is the standard adopted by a competent authority, such as the respondent, it is absolutely essential that other parties, including the appellant whose products are under threat of withdrawal, know precisely what is the standard which is being imposed, and with which it must comply.

  43. The advantage of a national or international standard is that it is established and imposed on a wholly objective basis. Its objective criteria are set out for all interested parties to see. It permits any company wishing to be on the market to know exactly what it must do and the degree to which it must comply, in order to meet the objective criteria established and published. That is the norm. While I am unaware of what such a standard might include in the case of closed system containers and no criteria have been published by the respondent or even identified by them in the course of these proceedings, it seems reasonable to assume such a national or international standard in the case of containers would be set with a view to ensuring, for example, that the standard to be met was of a “zero tolerance” nature (not considered appropriate in most cases according to the case law of the European Court of Justice). Such a standard might alternatively be sufficiently met by a significant reduction in the risk involved, as implied by the content of the letter of the 19th November, 2001. I imagine such a standard would also, in the case of containers, likely provide for any tolerance in terms of spillage, the mechanism to be used for opening and closing the same, criteria to be applied in the course of manufacture, for example the type of material and its strength, or density, the types of mechanisms to be used in an acceptable closure system, and whether the system was to be closed in the sense of the entire container, as opposed simply to the aperture. These, and no doubt others, would be provided for as part of the objective criteria established by national or international standards adopted by the respondent or proposed as national standards.

  44. Given that the onus is on the respondent to establish, at least prima facie, that the appellant’s containers no longer meet some or all of the appropriate standards, the respondent must indicate clearly and precisely to the appellant the features and characteristics of the containers, and more particularly the objective criteria, which the appellant was now being obliged to meet. On the contrary, when adopting a standard which is, in reality, the commercial packaging or containers of competitor companies, as here, no objective standards were established. It would have been possible for the respondent, through the ACVM, to have set out objective criteria which it considered ought to be met, bearing in mind its consideration of the competitor products. It did not do so. It was in fact wholly unclear, and remains unclear up until this point, whether the closed system adopted by others, for example

    1. eliminated altogether or simply reduced the likelihood of spillage or welling at all points in the process of manufacture operation and use;

    2. if it allowed for any spillage at all, at what level this was permitted or at what point in the manufacture, packaging, operation or use;

    3. took into account (as was a matter of concern to the Liaison Committee in the COT report) possible exposure to the operator at the point of setting up or dismantling, and so forth.

    Did the competitor containers meet all the undisclosed criteria or some, and to what extent? Against what precise criteria or characteristics in the competitor company containers was the appellant’s system of delivery being compared? None of the criteria apparently adopted by the respondent was published or notified or in any way transparent. The respondent, through the ACVM process, including that on appeal, refused to say what the particular criteria of the competitor product containers were, on the alleged basis that what it was considering were the containers of the appellant.

  45. It is a clear principle of both national and Community law that an appellant in circumstances such as the present should know the precise case being made against it in respect of its products allegedly not complying with so-called “standards”. The process adopted by the respondent is not, on the basis of a wholly opaque standard being imposed, in compliance with principles relating to fairness of procedures, and did not in this case, meet the legal requirements necessary to guarantee constitutional fairness to the appellant.

    Time Constraints

  46. This is the final sample issue which I wish to consider. The evidence was that for the purposes of the appeal to the ACVM from its own decision, the appellant was allowed a very restricted time to prepare for the same, and evidence was given that this came “out of the blue”. The time constraints arose, inter alia, against the following background. Although there were no national or international standards being implemented, and no detailed information as to the criteria being applied by the respondent to the appellants’ products, the appellant was informed that the decision, at least at appeal level, would also include references to internationally published material, together with other material. The appellant, in light of the opaque nature of the process and in order to have some reasonable opportunity of being appropriately prepared and heard, requested an adjournment of the appeal hearing. In order to ensure a fair hearing on the merits on appeal, they also, directly and through their solicitors, objected to the time and personnel constraints being imposed by the respondent through the ACVM appeal process. This application for an adjournment was refused. The result was that the appellant had nine working days to prepare for the appeal. Its expert, Professor Hynes, had merely two working days to prepare an expert report, endeavouring, in the process, to review all of the appropriate materials and/or literature.

  47. On the further issue of the 20 - 30 minute time limit imposed on the appellant for oral presentation of the appeal, it was said in writing that this was the “norm” in the case of many EU equivalent processes, and was considered adequate.

  48. It is true that in many EU jurisdictions and including in the Community institutions themselves, a limit is placed on the time available to make oral representations. The distinguishing feature, however, in such circumstances is that all of the relevant material, of whatever nature, is made available in writing by one side to the other, well prior to the oral hearing date. So also is all the argument intended to be presented, of whatever nature, on the part of each of the parties, which includes all appropriate references to authorities or published materials, and in a case such as the present case, full references to original materials and/or extracts therefrom upon which either party is relying. In such circumstances everything is known in advance to both parties, each party has had an opportunity to respond to the other party’s submissions, and a limit on the time for oral hearing is considered as good administrative practice, and appropriate (with exceptions always available to provide for particularly difficult or important cases).

  49. In the absence of that type of exchange of detail, it is not correct in law to impose such time limits or to refuse a reasonable request for an adjournment, as occurred here, on the basis of a norm which applies to an entirely different, open, full and transparent procedure. In consequence of so doing, it became clear during the appeal process and during the course of the High Court proceedings that certain materials cited by the ACVM, and/or the respondents themselves, as material which would be used in the course of the appeal process, in fact consisted of extracts from internet sites containing comment on original published material, which, according to the appellant’s counsel – and not really challenged on behalf of the respondent – were not supportive of the stance adopted in the original material, as published, and could not be stood over. Difficulties also arose in relation to the approach of the rapporteur to the ACVM, which do not need to be detailed here.

  50. Secondly, difficulties arose in relation to an important aspect of the case being made on behalf of the respondent. It was discovered, but very late in the day, that an extremely informal test, which became known as the “toilet test” had taken place under the control of Dr. Beechinor of the respondent. Quite apart from the fact that he was not identified as the person who had carried out the test, the test was carried out in the most basic and non-laboratory conditions which could be imagined and its results accepted, while the appellant remained entirely ignorant of the circumstances in which the test was carried out. On the other hand the appellant had carried out laboratory controlled tests under the supervision of Professor Hynes, in circumstances where, generally speaking, the quality of the testing carried out appears to have considerably exceeded that of the informal test. For the purposes of the appeal process, however, the significance of the test carried out by Dr. Beechinor was twofold. Firstly, he ought have been identified as the person carrying out the test, and perhaps even more importantly, the nature of the test carried out ought to have been fully disclosed to the appellant in advance, so as to enable it prepare an appropriate response. The effects of this aspect of the appellant’s case were not dealt with by the learned High Court judge in his judgment, which described the “toilet test” merely as being sensible.. Although it is not always necessary to reply to every point made in the course of proceedings, this particular complaint was one of the fundamental matters raised on behalf of the appellant, and ordinarily would have been the subject of a finding.

    Conclusion

  51. In light of the above examples, which are to be taken as mere examples of the manner in which the most basic requirements of transparency and disclosure were not complied with, I am satisfied that the learned High Court judge erred in law in finding that the procedures applicable to what is in reality an annulment of a valuable property right were either adequate or sufficient in law to meet the requirements of constitutional justice and fair procedures.

    B. The Bias Ground

  52. The bias ground is to some considerable extent connected with or integrated into the unfair procedures ground but stands also as a separate discrete ground and it seems to me appropriate to deal with it on that basis. It will be recalled that bias is alleged on two bases, that is to say subjective bias in respect of a named person, and objective bias. It is necessary to deal with both of these.

    The Allegation of Subjective Bias

  53. As to subjective bias, the appellant had sought a declaration that both the ACVM and, consequentially, the respondent, had a predetermined view in relation to the decisions made concerning the appellant’s products, by reason of the fact that a senior employee of the respondent had been involved in every step of the proceedings but in particular in respect of one issue. It was alleged that Dr. Beechinor, the Veterinary Director of the respondent, had, in the course of conversations with Mr. Declan O’Brien, stated in effect that the appellant’s products would be removed (from the market) regardless of what was said at the appeal. Dr. Beechinor denied on affidavit saying that the appeal would be unsuccessful. Neither party was able to recall the precise words used. Having regard to the evidence the learned High Court judge considered that Dr. Beechinor “at most .... may have expressed his opinion that the appeal was unlikely to succeed”. The High Court judge considered that such a statement, even if made, did not establish on the part of the appellant that there was any element of subjective bias by the ACVM in relation to the appeal process.

  54. Mr. McDermott, counsel for the appellant, pointed out that the learned trial judge had recognised and accepted in the course of the trial that Mr. O’Brien had given a very plausible account of what had occurred, and while not recalling the exact words used he (Mr. O’Brien) had “no doubt about the effect of the words”. He argued that the learned trial judge was in error in his finding of fact which he contends was not properly based on the evidence, and that Mr. O’Brien was a completely independent witness. In any event it is argued that, even if the learned trial judge’s assessment of the evidence was correct, nevertheless the expression by Dr. Beechinor as a decision maker, or as part of the decision making process that “an appeal was unlikely to succeed” constitutes an invidious remark indicating that the appeal decision had already been made, and is sufficient evidence of subjective bias on his part. Mr. McCullough, for the respondent, said that the learned trial judge’s finding that the appellant is estopped from raising the issue of subjective bias because they took no stance in relation to Dr. Beechinor during the course of the appeal process is in law correct. I am of the view that this is correct, and well established in the case law. In any event, for the reasons which I now set out, I do not think that the appellant could succeed on the issue of subjective bias.

  55. It is not necessary to consider the case law in any detail, because subjective bias is a matter of fact to be established in the course of evidence. The learned trial judge heard all the evidence which was by way of cross-examination on the affidavits filed. He was in the best position to come to a view, having regard to the particular vantage point which he has in assessing evidence by reference to what was said in the course of the hearing. What the learned trial judge said in relation to this, having set out what was averred to by Mr. O’Brien in his affidavit of the 16th January, 2003:

    Mr. O’Brien was cross-examined on his affidavit. He could not remember the words used by Dr. Beechinor but that the effect of the words was that the products would be removed regardless of what was said at the appeal. He had read Dr. Beechinor’s affidavit in response to his affidavit. The conversation was in relation to sheep dip products generally .... He was unable to recall precisely the context in which he alleged Dr. Beechinor made the comments in question. He could not recall whether it was in response to a question posed by him but it may have been. He was unable to recall with any precision anything else that was discussed. He told Mr. McCartan, the Managing Director of the applicant, of the conversation on the 4th December, 2002 .... In a subsequent telephone conversation with Dr. Beechinor he may have said that what he told Mr. McCartan was that Dr. Beechinor had said that it was unlikely that the applicant would be successful on the appeal. In the course of that conversation Dr. Beechinor had disagreed with the witness’s account of the conversation. He did not agree that Dr. Beechinor had merely explained to him his understanding of the concerns of ACVM with sheep dip products, and denied that he told Dr. Beechinor that at the time he swore his affidavit he could not recall what he had told Mr. McCartan but had relied on Mr. McCartan’s account of what he had told him.
  56. The learned High Court judge then went on to say how careful Mr. O’Brien had been not to sign a draft affidavit which, on presentation, had included the alleged precise words stated by Dr. Beechinor, because Mr. O’Brien had been unable to recall these. The learned High Court judge continued:

    Having considered the evidence of the witness on affidavit and in cross-examination and also that of Dr. Beechinor on affidavit and in cross-examination, my conclusion is as follows. I am satisfied that a discussion took place concerning the applicant’s position. Both Mr. O’Brien and Dr. Beechinor were aware of the attitude of the ACVM. Dr. Beechinor was aware of the decision of the ACVM reached on that day. I think it likely that Mr. O’Brien anticipated a decision of the ACVM unfavourable to the applicant and anticipated an appeal. I do not accept that Dr. Beechinor said that an appeal would be unsuccessful; at most he may have expressed his opinion that the appeal was unlikely to succeed. In these circumstances I am not satisfied that the applicant has established any element of prejudgment in relation to the appeal process.
  57. The learned trial judge was entitled to have considerable regard to the affidavits filed and to the evidence of Mr. O’Brien, who appears to have given careful evidence as to the circumstances surrounding his conversations with Dr. Beechinor. I am equally satisfied that the learned trial judge was entitled to have regard to the above surrounding matters with a view to ascertaining the certainty with which Mr. O’Brien may have recalled the incident. Further, he was entitled to accept or reject the evidence of one or other of the parties. In reaching the conclusion that there was no element of prejudgment, at least from a subjective bias point of view, his conclusions in law cannot be considered wrong as he had ample evidence before him upon which to reach his findings. This is so, even if the words which were used were those the learned trial judge considered were likely used.

    The Allegation of Objective Bias

  58. The issue of objective bias has been raised in a number of cases before this Court in the recent past. The authoritative test which has been established for some considerable time is found in the judgment of Denham J. in Bula Limited v Tara Mines Limited (No. 6) [2000] 4 I.R. 412. At p.441 she stated:

    .... it is well established that the test to be applied is objective, it is whether a reasonable person in the circumstances would have a reasonable apprehension that the applicants would not have a fair hearing from an impartial judge on the issues. The test does not invoke the apprehension of the judge or judges. Nor does it invoke the apprehension of any party. It is an objective test - it invokes the apprehension of the reasonable person.
  59. This test has been applied in several subsequent cases, and most recently in the case of Kenny v. Trinity College, Dublin [2008] 2 I.R. 40, in which the judgment of Fennelly J. adopted and applied the test laid down in Bula v. Tara (No. 6) supra. Having cited the judgment of Denham J. in the above case, Fennelly J. continued:

    The hypothetical reasonable person is an independent observer, who is not over sensitive, and who has knowledge of the facts. He would know both those which tended in favour and against the possible apprehension of a risk of bias .... However, the hypothetical independent reasonable observer would also know the substance and tenor of the allegation made in the proceedings.

    The test of objective bias is expressed in general terms. Its application demands an appreciation of all the circumstances of the individual case, followed by a particularly careful exercise of the faculty of judgement.

  60. The basis for the allegation that the decisions of the ACVM and of the respondent were tainted with objective bias arises in particular from the intimate role which Dr. Beechinor played in all of the steps in the process, up to and including the decision made by the respondent in February, 2003. Briefly the appellant says that the role of Dr. Beechinor included the following:

    1. He was chairman of the Liaison Committee to the ACVM who reported its decision and recommendations on OP packaging to the ACVM in March, 2000;

    2. Almost all of the correspondence from the respondent to the appellant was under his hand;

    3. Dr. Beechinor it was who suggested that the original decision of the ACVM was that only a closed delivery system was acceptable, when in fact the wording of the respondent’s letter of the 19th November, 2001 notifying the decision of the ACVM was that “closed systems, or similar aimed at reducing operator exposure to the concentrate”, was acceptable.

    4. Dr. Beechinor, although not a member of the ACVM, sat in on the meeting of the ACVM when it made its decision. He also sat in on the ACVM meeting which heard the appeal from the earlier decision of that body, sitting next to the Chairman and, according to the appellant, effectively directing the appeal.

    5. Dr. Beechinor had, according to the appellant, delegated to himself “the original job of coming up with an independent look at the Willis Corroon Hinton report” by the ACVM which heard the appeal. According to the appellant, in his correspondence before the appeal, Dr. Beechinor made it clear that he had a predetermined view that if the appellant did not appeal, or lost the appeal, the respondent would withdraw the appellant’s product and institute a recall of it.

    6. Dr. Beechinor did not withdraw from sitting with the ACVM after the appeal on the 18th December, 2002, but rather remained sitting with the ACVM and participated in its deliberations before that Committee reached its decision which was communicated by letter of the 19th December, 2002.

    7. The decision of the ACVM on the appeal was communicated to the appellant on that date, not by the Chairman of the ACVM or by the rapporteur of the Committee, but by Dr. Beechinor on behalf of the respondent. The appellant states that it is quite unclear why Dr. Beechinor, who is not a member of the Committee, was the person who formulated the communication of its decision to the appellant. At the meeting of the IMB on the 26th February, 2003 the Chairman of the ACVM “.... drew attention to Dr. Beechinor’s letter of the 19th December, which letter sets out the view of the ACVM ....”

    8. Dr. Beechinor prepared the one page memorandum, undated and unsigned, entitled “Status of Organophosphate Sheep Dip – February 19 2003” which was before the respondent when it made its final decision.

    9. Dr. Beechinor was, it was disclosed during cross-examination, the author of the document entitled “Status of Organophosphate Sheep Dip – February 19 2003”, the document considered by the ACVM and in respect of which its comment was sought, and which report was subsequently modified to include the comments of the ACVM in the final version of the same report dated the 19th February, 2003 Explanatory Note. In the course of exchanges between counsel for the respondent and the Court in the course of the hearing, it was stated on behalf of the respondent that Dr. Beechinor had “compiled” this report.

  61. Having regard to the foregoing it is argued on behalf of the appellant that the learned High Court judge was wrong when he concluded that the reasonable person viewing the above involvement and the effect of that involvement on the decision making process would not consider the decision maker to be objectively biased.

    Conclusion

  62. The test in Bula Limited v. Tara Mines Limited, supra, which has been set out at the commencement of this section of the judgment, and as developed by Fennelly, J., in the case of Kenny v. Trinity College, supra., is worth repeating:

    The hypothetical reasonable person is an independent observer, who is not over sensitive, and who has knowledge of the facts. He would know both those which tended in favour and against the possible apprehension of a risk of bias .... However, the hypothetical independent reasonable observer would also know the substance and tenor of the allegation made in the proceedings.

    [emphasis added]

  63. Most of the difficulties which arose in this case were not, it seems to me, difficulties of either subjective or objective bias, in reality. They were, rather, those flowing from the absence of any appropriate standing orders and more particularly any appropriately adopted and published procedures concerning the review process, which procedures ought to have been adopted in the instant case. If proper procedures existed, this would have eliminated a great deal of what gave rise to this complaint. I am nevertheless satisfied that a reasonable person, properly informed – and this is a key requirement in law - would not consider that the members of the ACVM Committee, all highly qualified and expert individuals, would be influenced against the appellant by persons reporting to them or by persons, not having a vote or a deciding function in the Committee, furnishing information or explanations. I do not consider that, in the particular circumstances of this case, the learned trial judge misdirected himself in the application of the appropriate principles for the establishment of objective bias, and in rejecting this claim.

    3. The Precautionary Principle Ground

  64. In the course of his judgment the learned High Court (Finnegan P.) found that the “precautionary principle” applied to a case such as the present case. Counsel for the appellant agrees that the precautionary principle applies, or may be applied, but says that in consequence there is a high onus resting on the respondent, including its ACVM, in the case of the suspension of a marketing authorisation on scientific grounds under Directive 2001/82/EC, to establish its case. According to the appellant’s argument, the respondent is required to establish, in the exercise of the jurisdiction which it has concerning veterinary medicinal products, that the product in question is “harmful under the conditions of use stated at the time of application for authorisation or subsequently”. In the present case it is said that the decision taken is based on new packaging ideas produced by competitors in the same veterinary pharmaceutical industry, rather than on up to date scientific studies of the type required.

  65. The appellant relies in particular on certain cases coming before the European Court of Justice or before the Court of First Instance, including the decision of the Court of First Instance in Joined Cases T-74/00 and others, Artegodan [2002] ECR II/ 4959, in particular the requirement imposed on a competent authority to conduct an assessment of the “benefit/risk balance in light of new scientific data”. In that regard, it is argued, the onus rests on the competent authority to establish that one of the conditions for the withdrawal, variation or suspension of a marketing authorisation exists, and where doubts lead to an unfavourable assessment of the benefit/risk balance of the product in question. At Paragraph 195 of the latter judgment the Court of First Instance held:

    As the validity of an authorisation is in principle limited to a renewable period of five years, in those circumstances the system of prior authorisation allows the presumption that, during the five year period, in the absence of any solid evidence to the contrary, the medicinal product in question has a favourable benefit/risk balance subject always to the possibility of suspending the authorisation in cases of emergency.

    [emphasis added]

    Further, at paras. 210 and 211, the court stated:

    Furthermore, it is common ground that the use, in the present case, of a criterion for assessing the efficacy of the substances in question which differs from that applied in 1996 is based solely on the purported development of a ‘consensus’ within the medical community on the criterion for assessing the efficacy of medicinal products in the treatment of obesity, as confirmed by the Commission on numerous occasions both in its written observations and at the hearing (see above, paragraphs 162 and 164). That new consensus is purportedly reflected in the CPMP Note for Guidance and the national guidelines, which were cited in the CPMP's scientific conclusions. Yet, neither those documents nor the scientific conclusions of the CPMP make any reference to new scientific data or information which were not available in 1996 and would explain the development of that consensus.

    In those circumstances, the Court finds that mere changes in a scientific criterion or, in more concrete terms, in good clinical practices - that is to say, therapeutic practices considered to be the most appropriate in the light of current scientific knowledge, even if based on a ‘consensus’ in the medical community, cannot on their own justify the withdrawal of a marketing authorisation of a medicinal product under Article 11 of Directive 65/65 where, as has been held above (paragraphs 192 to 195), those changes are not based on new scientific data or information.

  66. The appellant submits that the precautionary principle relied upon by the respondent late in its legal submissions in the High Court was neither properly or correctly applied either by the respondent or by its Committee, the ACVM, in the course of the decision making process.

  67. It is argued on behalf of the respondent that the learned trial judge in his conclusions on the application of the precautionary principle was correct. Counsel for the respondent points to the fact that the appellant accepted that there were “still risks” with OP products, notwithstanding that users wore protective equipment, and argued that the respondent was entitled to proceed on the basis of the precautionary principle.

    Conclusion

  68. What the learned High Court judge stated in relation to this principle is as follows:

    It is common case that there was no incidence of adverse human reaction to the applicant’s products. However it is also abundantly clear that there are serious concerns as to the effect on human health of OP products: see for example the COT Report. In addition to the principles urged by the applicant, it is appropriate to have regard to the precautionary principle. I am satisfied having regard to the documented concerns in relation to OP products that a decision reached by the Board to withdraw the authorisation is proportionate.
  69. It is this statement on the adoption and application of the precautionary principle which the appellant says was wrongly dealt with and applied by the learned High Court judge. The appellant points to the fact, correct in my view, that the precautionary principle has become a general principle of EU Law and is confirmed by two leading judgments of the Court of First Instance, Case No. T-74/00, Artegodan GMBH v. Commission of the European Communities, supra, and the Case No. T-13/99 of Pfizer Animal Health v. Council of the European Union [2002] ECR II/ 3318. A particular aspect of the application of the precautionary principle is invoked on behalf of the appellant. In the first of the above cases the general principle was established, which is not in dispute between the parties. This requires competent authorities to take all appropriate measures to prevent specific potential risks to public health, safety and the environment by giving precedence to the requirements related to the protection of those interests, and without having to await definitive evidence of the risk involved.

  70. In the first of the above cases the Court of First Instance annulled the Commission decision regarding an obesity medicinal product for human use, the Court observing that “good clinical practices” did not satisfy the requisite standard. In that regard it stated:

    The Court finds that mere changes in a scientific criterion or, in more concrete terms, in good clinical practices – that is to say, therapeutic practices considered to be the most appropriate in the light of current scientific knowledge – even if based on a “consensus” in the medical community, cannot on their own justify the withdrawal of a marketing authorisation of a medicinal product under Article 11 of Directive 65/65 where, as has been held above, those changes are not based on new scientific data or information.
  71. The same Court also dealt with the matter in Pfizer Animal Health, supra., and the appellant relies on certain extracts from that judgment also. The appellant recognises that a full assessment might not always be possible. However, in the case of the withdrawal of an authorisation, the Court of First Instance has emphasised that such a withdrawal must be based on a scientific assessment of the risks involved. It has dealt with this at some length in that judgment - commencing at paragraph 135:

    (b) Findings of the Court

    135.

    In view of the parties' arguments, it is necessary, first, to define the ‘risk’ which must be assessed when the precautionary principle is applied. It is then appropriate to identify the two components of the task which falls to the competent public authority when a risk assessment is performed. Finally, it is necessary to determine how the burden of proof should be apportioned in the matter and to recall the settled case-law concerning the scope of judicial review in a situation of this kind.

    (i) The ‘risk’ assessed when the precautionary principle is applied

    136.

    It is clear from Article 11(1) and (3) of Directive 70/524 that the Community institutions may withdraw authorisation of an additive in feedingstuffs where use of the additive constitutes ‘a danger to .... human health’.

    139.

    It is appropriate to bear in mind that, as the Court of Justice and the Court of First Instance have held, where there is scientific uncertainty as to the existence or extent of risks to human health, the Community institutions may, by reason of the precautionary principle, take protective measures without having to wait until the reality and seriousness of those risks become fully apparent (the BSE judgment, cited at paragraph 114 above, paragraph 99, the NFU judgment, cited at paragraph 114 above, paragraph 63, and the judgment at first instance in Bergaderm and Goupil v Commission, cited at paragraph 115 above, paragraph 66).

    140.

    It follows, first, that as a result of the precautionary principle, as enshrined in Article 130r(2) of the Treaty, the Community institutions were entitled to take a preventive measure regarding the use of virginiamycin as an additive in feedingstuffs, even though, owing to existing scientific uncertainty, the reality and the seriousness of the risks to human health associated with that use were not yet fully apparent.

    141.

    A fortiori, the Community institutions were not required, for the purpose of taking preventive action, to wait for the adverse effects of the use of the product as a growth promoter to materialise (see, in relation to the interpretation of Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds (OJ 1979 L 103, p. 1), the judgment of the Court of Justice in Case C-355/90 Commission v Spain [1993] ECR I-4221, paragraph 15).

    142.

    Thus, in a situation in which the precautionary principle is applied, which by definition coincides with a situation in which there is scientific uncertainty, a risk assessment cannot be required to provide the Community institutions with conclusive scientific evidence of the reality of the risk and the seriousness of the potential adverse effects were that risk to become a reality (see, in that context, Mondiet, cited at paragraph 115 above, paragraphs 29 to 31; and Spain v Council, cited at paragraph 115 above, paragraph 31).

    143.

    However, it is also clear from the case-law cited at paragraph 139 above that a preventive measure cannot properly be based on a purely hypothetical approach to the risk, founded on mere conjecture which has not been scientifically verified (see also, to that effect, EFTA Surveillance Authority v Norway, cited at paragraph 115 above, in particular paragraphs 36 to 38).

    144.

    Rather, it follows from the Community Courts' interpretation of the precautionary principle that a preventive measure may be taken only if the risk, although the reality and extent thereof have not been ‘fully’ demonstrated by conclusive scientific evidence, appears nevertheless to be adequately backed up by the scientific data available at the time when the measure was taken.

    145.

    As Pfizer has rightly pointed out, the taking of measures, even preventive ones, on the basis of a purely hypothetical risk is particularly inappropriate in a matter such as the one at issue here. The parties do not dispute that in such matters a ‘zero risk’ does not exist, since it is not possible to prove scientifically that there is no current or future risk associated with the addition of antibiotics to feedingstuffs. Moreover, as Pfizer has also rightly pointed out, that approach is even less appropriate in a situation of this kind, in which the legislation already makes provision, as one of the possible ways of giving effect to the precautionary principle, for a procedure for prior authorisation of the products concerned (see, as to the specific procedural obligations relating to such prior authorisation, Greenpeace France, cited at paragraph 115 above, paragraph 44).

    146.

    The precautionary principle can therefore apply only in situations in which there is a risk, notably to human health, which, although it is not founded on mere hypotheses that have not been scientifically confirmed, has not yet been fully demonstrated.

    151.

    In that regard, it is for the Community institutions to determine the level of protection which they deem appropriate for society. It is by reference to that level of protection that they must then, while dealing with the first component of the risk assessment, determine the level of risk - i.e. the critical probability threshold for adverse effects on human health and for the seriousness of those possible effects - which in their judgment is no longer acceptable for society and above which it is necessary, in the interests of protecting human health, to take preventive measures in spite of any existing scientific uncertainty (see, to that effect, Case C-473/98 Toolex [2000] ECR I-5681, paragraph 45). Therefore, determining the level of risk deemed unacceptable involves the Community institutions in defining the political objectives to be pursued under the powers conferred on them by the Treaty.

    152.

    Although they may not take a purely hypothetical approach to risk and may not base their decisions on a ‘zero-risk’ (see paragraph 145 above), the Community institutions must nevertheless take account of their obligation under the first subparagraph of Article 129(1) of the Treaty to ensure a high level of human health protection, which, to be compatible with that provision, does not necessarily have to be the highest that is technically possible (Case C-284/95 Safety Hi-Tech [1998] ECR I-4301, paragraph 49).

  72. All of the foregoing appears to me to be not in dispute between the parties, save that it appears clear from the submissions of Mr. McCullough to the Court on this appeal, that the respondent contends it is entitled to impose their decision on a “zero risk” basis, which is not in accordance with paragraphs 145 and 152 of the above judgment. The court continued:

    153.

    The level of risk deemed unacceptable will depend on the assessment made by the competent public authority of the particular circumstances of each individual case. In that regard, the authority may take account, inter alia, of the severity of the impact on human health were the risk to occur, including the extent of possible adverse effects, the persistency or reversibility of those effects and the possibility of delayed effects as well as of the more or less concrete perception of the risk based on available scientific knowledge.

    154.

    As regards the second component of risk assessment, the Court of Justice has already had occasion to note that in matters relating to additives in feedingstuffs the Community institutions are responsible for carrying out complex technical and scientific assessments (see Case 14/78 Denkavit v Commission [1978] ECR 2497, paragraph 20). The Council itself has drawn attention in its arguments to the fact that the decision to withdraw the authorisation of virginiamycin was based on extremely complex scientific and technical assessments over which scientists have widely diverging views (see in particular (4) below).

    155.

    In such circumstances a scientific risk assessment must be carried out before any preventive measures are taken.

    156.

    A scientific risk assessment is commonly defined, at both international level (see the provisional communication from the Codex Alimentarius Commission, cited at paragraph 147 above) and Community level (see the Communication on the Precautionary Principle, the Communication on Consumer Health and Food Safety and the green paper, cited at paragraphs 118 and 124 above), as a scientific process consisting in the identification and characterisation of a hazard, the assessment of exposure to the hazard and the characterisation of the risk.

    157.

    In that regard, it is appropriate to point out, first, that, when a scientific process is at issue, the competent public authority must, in compliance with the relevant provisions, entrust a scientific risk assessment to experts who, once the scientific process is completed, will provide it with scientific advice.

    158.

    As the Commission pointed out in its Communication on Consumer Health and Food Safety (see paragraph 124 above), scientific advice ‘is of the utmost importance at all stages of the drawing up of new legislation and for the execution and management of existing legislation’ (page 9 of the Communication). Furthermore, the Commission stated there that it ‘will use this advice for the benefit of the consumer in order to ensure a high level of protection of health’ (ibid). The duty imposed on the Community institutions by the first subparagraph of Article 129(1) of the Treaty to ensure a high level of human health protection means that they must ensure that their decisions are taken in the light of the best scientific information available and that they are based on the most recent results of international research, as the Commission has itself emphasised in the Communication on Consumer Health and Food Safety.

    159.

    Thus, in order to fulfil its function, scientific advice on matters relating to consumer health must, in the interests of consumers and industry, be based on the principles of excellence, independence and transparency, as stated in both the preamble to Commission Decision 97/579 and the Commission's Communications on the Precautionary Principle and on Consumer Health and Food Safety.

    160.

    Second, it is common ground between the parties that, when the precautionary principle is applied, it may prove impossible to carry out a full risk assessment, as defined at paragraph 156 above, because of the inadequate nature of the available scientific data. A full risk assessment may require long and detailed scientific research. The case-law cited at paragraph 139 above shows that unless the precautionary principle is to be rendered nugatory, the fact that it is impossible to carry out a full scientific risk assessment does not prevent the competent public authority from taking preventive measures, at very short notice if necessary, when such measures appear essential given the level of risk to human health which the authority has deemed unacceptable for society.

    161.

    In such a situation, the competent public authority must therefore weigh up its obligations and decide either to wait until the results of more detailed scientific research become available or to act on the basis of the scientific information available. Where measures for the protection of human health are concerned, the outcome of that balancing exercise will depend, account being taken of the particular circumstances of each individual case, on the level of risk which the authority deems unacceptable for society.

    162.

    So, where experts carry out a scientific risk assessment, the competent public authority must be given sufficiently reliable and cogent information to allow it to understand the ramifications of the scientific question raised and decide upon a policy in full knowledge of the facts. Consequently, if it is not to adopt arbitrary measures, which cannot in any circumstances be rendered legitimate by the precautionary principle, the competent public authority must ensure that any measures that it takes, even preventive measures, are based on as thorough a scientific risk assessment as possible, account being taken of the particular circumstances of the case at issue. Notwithstanding the existing scientific uncertainty, the scientific risk assessment must enable the competent public authority to ascertain, on the basis of the best available scientific data and the most recent results of international research, whether matters have gone beyond the level of risk that it deems acceptable for society (see paragraphs 150 to 153 above). That is the basis on which the authority must decide whether preventive measures are called for.

    163.

    Furthermore, a scientific risk assessment must also enable the competent authority to decide, in relation to risk management, which measures appear to it to be appropriate and necessary to prevent the risk from materialising.

    ....

    169.

     

    It follows that in this case, in which the Community institutions were required to undertake a scientific risk assessment and to evaluate highly complex scientific and technical facts, judicial review of the way in which they did so must be limited. The Community judicature is not entitled to substitute its assessment of the facts for that of the Community institutions, on which the Treaty confers sole responsibility for that duty. Instead, it must confine itself to ascertaining whether the exercise by the institutions of their discretion in that regard is vitiated by a manifest error or a misuse of powers or whether the institutions clearly exceeded the bounds of their discretion.

    170.

    In particular, under the precautionary principle the Community institutions are entitled, in the interests of human health to adopt, on the basis of as yet incomplete scientific knowledge, protective measures which may seriously harm legally protected positions, and they enjoy a broad discretion in that regard.

    171.

    However, according to the settled case-law of the Court of Justice and the Court of First Instance, in such circumstances, the guarantees conferred by the Community legal order in administrative proceedings are of even more fundamental importance. Those guarantees include, in particular, the duty of the competent institution to examine carefully and impartially all the relevant aspects of the individual case (Case C-269/90 Technische Universität München [1991] ECR I-5469, paragraph 14).

    172.

    It follows that a scientific risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on the principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures.

    173.

    It is in the light of the foregoing that the Court must examine whether the risk assessment carried out by the Community institutions in the present case is vitiated by the errors alleged by Pfizer.

    [emphasis added]

  73. In the course of the High Court proceedings the above case law of the Court of First Instance of the European Communities concerning the correct definition and in particular the manner in which courts should apply the precautionary principle, developed in effect by that court, and now adopted in the Articles of the extant Treaty, was not fully considered in argument. It is therefore not at all surprising that the learned High Court judge took the rather pithy view he did in relation to the application of the precautionary principle.

  74. However, it is clear from the above extracts from the Court of First Instance jurisprudence, and in particular from the detailed principles established in the case of Pfizer Animal Health case, supra., that the precautionary principle is highly technical in nature and subject to considerable constraints in its application. It will be seen that there are, at least, four important factors to be considered: firstly, there is a presumption that a product which has been licensed for sale is safe when used in the manner for which it has been authorised; secondly, that since the product authorisation only last for a finite period, it is for the competent authority to prove that, either at the date when the product was licensed, or subsequently, it was or is no longer, in fact, safe, even applying the precautionary principle; thirdly, where the precautionary principle is applied, and because this does not require the competent authority to await evidence of a definite established risk, the withdrawal of the product or the authorisation must be based on the most up to date, comprehensive scientific or technical information, based on the principles of excellence, independence and transparency; and finally, that a risk assessment carried out as thoroughly as possible on the basis of scientific advice founded on those principles of excellence, transparency and independence is an important procedural guarantee whose purpose is to ensure the scientific objectivity of the measures adopted and preclude any arbitrary measures.

  75. I am satisfied, having regard to the development of the law, that so far as concerns the present series of steps taken by the respondent, as the competent authority for withdrawing an authorisation of this type, it did not comply with the conditions surrounding the applicability of the precautionary principle in the context of the withdrawal of a product or the suspension of an authorisation, as the respondent did not comply with the above principles in any material way. It is not necessary to enumerate the several ways in which the application of the precautionary principle was deficiently applied, as examples are given above in relation to the so-called unscientific toilet test, and having regard to the absence of, or any apparent charging of appropriate independent experts with the exercises properly to be carried out, as well as the absence of any real technical or scientific standards.

    Remedies

  76. Having regard to the foregoing, I am satisfied that the appellant is entitled to a declaration that the decision making process and procedures adopted by the respondent were not such as to guarantee constitutional justice and constituted unfair procedures. The appellant is also entitled to a declaration that established principles of Community Law circumscribing the application of the precautionary principle were not correctly applied by the respondent in the decision making process. To that extent the judgment of the High Court should be set aside.

  77. The consequences which may flow from the foregoing declarations require to be considered. The appellant has sought certiorari quashing the decision of the respondent, which would ordinarily flow from the above declarations. However, in the course of the appeal it became clear upon enquiry from the bench that the appellant adopted a closed system as and from a particular date, the precise date not being critical to my consideration of this aspect of the matter. Counsel for the appellant also confirmed that, as would be expected having regard to commercial reality, it was not the intention of the appellant to revert to the previous system which it had on the market for many years. The appellant made the changes necessary in consequence of the decision taken by the respondent, so as to ensure that it would remain in the market place. I do not think that any criticism can be made of that decision. In any event, since there is a claim to damages in the proceedings, if such a claim were successful, the appellant would be obliged to mitigate its losses and it seems clear that the only way in which that could occur was by adopting the closed system insisted upon by the respondent.

  78. In these circumstances it does not seem to me that it is appropriate that certiorari should be granted in respect of the decision made, because that remedy is intended to place the parties in the position in which they were originally and permits the matter, in the present case the decision to withdraw the appellant’s products from the market and/or to suspend their authorisations for those products, to be remitted to the decision maker, with a view to enabling the decision to be taken with appropriate respect for the constitutional principles applicable. That is now moot.

  79. There is, however, a claim for damages in these proceedings. In light of the judgment delivered, this is a matter not dealt with by the High Court, and it is inappropriate that this Court should embark on any such investigation when the matter has not been dealt with at first instance. There are two issues which arise in relation to damages. The first is whether or not, in the particular circumstances of these judicial review proceedings, damages in law lie. The second issue, namely, the assessment of any such damages, only arises where the appellant is in a position to establish as a matter of law that it is entitled to such damages in the particular circumstances of this case. I express no view on these two issues but rather would remit the proceedings to the High Court for the purposes of argument on one or both issues.

  80. In consequence of the foregoing I would allow the appeal, and set aside the judgment of the High Court and the orders made thereon, grant the declarations mentioned above and remit the matter to the High Court for argument on the issue of damages.

    E X H I B I T   “A”

    Re: Outcome of appeal to the Advisory Committee for Veterinary Medicines on Hygeia’s Winter Dip (VPA 10203/1/1) and Summer Dip (VPA 10203/2/1)

    On behalf of the Advisory Committee for Veterinary Medicines (ACVM) I would like to thank you for your written appeal documentation submitted on December 9th and for attending at the oral appeal heard on December 18th.

    During the oral appeal, which lasted for more than 1¼ hours, the ACVM heard an extensive presentation from yourself in relation to the background to the appeal, including the actions taken by your company previously to change the product formulation to a 10% strength and in the implementation of a packaging change in 1995 to the plastic containers and subsequently in introducing a child resistant closure to the containers. It was noted by the ACVM that your company implemented these changes of your own volition and that you firmly believed that, notwithstanding the fact that all chemicals carry some risk, that your product compared favourably with alternative delivery systems which are closed. The ACVM also heard from you in detail regarding:

    your response to the risk assessment conducted by the ACVM;

    the report of the Liaison Committee in March 2000;

    the relative merits and impact of peer reviewed literature cited in the ACVM risk assessment report;

    the report and conclusions of the UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (Organophosphates)

    as well as the sequence of communications between Hygeia and the IMB since you were notified of the ACVM decision on November 19th, 2001.

    The ACVM also heard from you regarding the actions taken by your company since that date in commissioning the Willis Corroon Hinton study and, more recently, in engaging the services of Professor Hynes to review the risk assessment. The ACVM noted your statements that a recent publication had identified a risk of non-compliance by farmers in the UK with use of the recommended closed delivery system for the particular product concerned and your concern that farmers might circumvent the procedure for transfer of the dip concentrate from such containers.

    The ACVM heard from your expert, Professor Hynes, regarding the studies conducted in his laboratory on pouring tests of two of the presentations of the products as well as his observations on the ACVM risk assessment and on his observations regarding the inhalation risk associated with the use of the Hygeia products including the vapour pressure of the product.

    After these presentations, the Rapporteur appointed by the ACVM, Mr. Rory Breathnach, as well as other Members of the Committee, raised several questions of clarification which were addressed by Professor Hynes and yourself. This segment of the oral appeal lasted for approximately 15 minutes. Following this, the Chairman of the ACVM, Mr. P. J. O’Connor, stated that the ACVM would proceed to deliberate on the contents of both the written and oral appeal. He also requested that I, as Veterinary Director, respond on behalf of the IMB to the telefax from Binchy’s Solicitors concerning the appeal procedure before the ACVM.

    Finally, the ACVM heard a closing remark from your Chairman, Mr. John Coyle, regarding the background of the Hygeia company and thanking the ACVM for their openness in meeting them and noting that the ACVM would now deliberate on the issue with an open mind.

    Following the withdrawal of your delegation from the meeting, the ACVM had an in depth discussion on the appeal. It considered the oral appeal as well as the extensive documentation previously provided on December 9th, 2002.

    Arising out of its discussion and considerations the ACVM altered its view on three elements of the risk analysis of their Risk Assessment Report associated with the use of Hygeia dips as follows:

    The risk of dripping of the concentrate down the side of the packet from the lid was changed from a high/very high classification to one of medium risk.

    The risk of inhalation of vapour was changed from a medium/high classification to one of low/medium.

    The risk of uncleaned pack disposal was changed from a medium/high to one of low/medium.

    I am directed by the ACVM to advise you of its decision.

    The ACVM considered that there was an unacceptable risk to human health arising from user contamination with the organophosphate concentrate during the administration to the dip bath, including risk of user contamination as a result of spillage from the product container during use, as well as dripping from the container during or following pouring of the concentrate into the dip bath. The ACVM also felt notwithstanding the fact that the product was available in three container sizes and that your company stated that it would reintroduce a smaller container, it could not assume that farmers would purchase and use only those container sizes appropriate only for use on a single occasion. This had been stated by your delegation to be of positive benefit in the assessment of user risk of your company’s products. The ACTM noted that notwithstanding the risk assessment of your delegation and Professor Hynes’ comments that there was a low risk of inhalation toxicity from the product during use, and while it accepted that the inhalation route of toxicity was not the most likely route of exposure for users of organophosphate sheep dips, there remains a risk to those individuals who are hypersensitive to organophosphate substances.

    Following the discussion, the ACVM is of the unanimous opinion that organophosphate concentrates supplied in open containers that require the user to pour the concentrate into the sheep bath carry an unacceptable risk of user exposure to the concentrate. For this reason the ACVM decided that Hygeia’s Winter Dip and Summer Dip as currently presented to the end-user carry an unacceptable risk of human exposure to the organophosphate concentrate which arises during their use for dipping sheep.

    Therefore, the ACVM have moved to suspend the marketing authorizations for both products in accordance with Regulation 19 of the Animal Remedies Regulations, 1996 and Article 83 of Directive 2001/82/EC. Consequently, you are directed not to continue to supply Winter Dip and Summer Dip to the market and that any product on the market currently should be recalled from retailers before January 31st, 2003. A draft recall notice must be provided to, and approved by, the IMB Inspectorate prior to issue by you. In addition, farmers should be advised by an appropriate notification from your company to return any unopened products to the source of purchase for uplifting by your company. This notification should also be submitted to the IMB for review and approval prior to issue. You are requested to contact Mr. John Lynch or Ms. Muireann Lydon, IMB Inspectorate, in relation to the conduct of the recall. The phone number is (01) 676 4971.

    I should point out that the suspensions will be lifted should applications for an appropriate delivery system be submitted and authorized by the IMB.

    [emphasis added]


Representations

O’Reilly SC, & McDermott for the appellant.

McCullough SC, for the respondent.


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