ANCARE NEW ZEALAND LTD V WYETH (NZ) LTD AND ANOR CA CA424/2007

ANCARE NEW ZEALAND LTD V WYETH (NZ) LTD AND ANOR CA CA424/2007 27 May 2009IN THE COURT OF APPEAL OF NEW ZEALAND CA424/2007 [2009] NZCA 211BETWEEN ANCARE NEW ZEALAND LIMITED Appellant AND WYETH (NZ) LIMITED First Respondent AND THE ENVIRONMENTAL RISK MANAGEMENT AUTHORITY Second Respondent Hearing: 8 October 2008 Court: Robertson , Arnold and Ellen France JJ Counsel: J O Upton QC and T Faasilili for Appellant B W F Brown QC and J G Hazel for First Respondent K I Murray and A J Allan for Second Respondent Judgment: 27 May 2009 at 12 pmJUDGMENT OF THE COURT A The appeal is allowed. B The cross-appeal is dismissed. C The first respondent must pay the appellant costs for a standard appeal on a band B basis, together with usual disbursements. We certify for two counsel.REASONS OF THE COURT(Given by Arnold J)Table of ContentsPara NoIntroduction [1]Background: the HSNO Act [8]Background: the facts [13]Issues on appeal [38]Did the High Court have jurisdiction under s 126? [40]Our evaluation [44]Was the key information "information" for the purposes of s 57? [50]Our evaluation [60]Did the High Court err in concluding that ERMA had the power to, and should have, accepted Wyeth's confidentiality undertaking? [68]Our evaluation [72]Decision [84]Introduction[1] The appellant, Ancare New Zealand Limited (Ancare), applied to the second respondent, the Environmental Risk Management Authority (ERMA), under the Hazardous Substances and New Organisms Act 1996 (the HSNO Act) to import or manufacture a hazardous substance, known as MEP 600. MEP 600 is a pour-on drench for sheep and cattle and is a new formulation of previously approved hazardous compounds. [2] The public part of the application did not specifically identify the hazardous substance or its chemical make-up. That information was contained in a confidential appendix to the application. [3] After ERMA had publicly notified the application, the first respondent, Wyeth (NZ) Limited (Wyeth), a competitor to Ancare in the veterinary medicines' market, advised ERMA that it wished to make submissions in relation to the application. It also requested further information about MEP 600 under the Official Information Act 1982 (the OIA), in particular the identity of the hazardous substance and its chemical composition. (Like the Judge below (Wild J), we willrefer to this as the key information.) Having consulted with Ancare, ERMA refused to release the key information, on the basis that to do so would unreasonably prejudice Ancare's commercial interests. [4] Wyeth decided to challenge this decision by seeking an Ombudsman's review. It asked ERMA to delay hearing Ancare's application in the meantime. It also offered, through its solicitors, to give a confidentiality undertaking that it said would protect Ancare's legitimate commercial interests in the key information. ERMA declined these arrangements, and proceeded with the hearing of the application. Wyeth's counsel attended the hearing l and made submissions which were essentially procedural in nature. [5] ERMA allowed Ancare's application, subject to conditions. Wyeth then appealed against ERMA's decision under s 126 of the HSNO Act, which permits an appeal against such a decision to the High Court on a question of law. The grounds of appeal were procedural rather than substantive in nature, focussing on the way that ERMA had proceeded and on the question whether it was entitled to withhold the key information. Following receipt of a minute from the Judge saying he wished to hear argument on jurisdiction, Ancare and ERMA argued that the High Court did not have jurisdiction to entertain the appeal under s 126 given the procedural focus of the grounds of appeal. [6] Wild J held that he did have jurisdiction: HC WN CIV 2006-485-2596 18 June 2007. Wyeth had argued that the key information was not "information" that could be withheld from the public under the HSNO Act. Wild J rejected that argument. However, he held that ERMA had misinterpreted the HSNO Act in the way it dealt with the proffered confidentiality undertaking, so that its hearing did not conform with the HSNO Act. Wild J quashed ERMA's decision and directed it to reconsider the application in light of the Court's interpretation of the HSNO Act. [7] Ancare has appealed against Wild J's findings on the jurisdictional and non- compliance points. Wyeth has cross-appealed on the information point.Background: the HSNO Act[8] The purpose of the HSNO Act is "to protect the environment, and the health and safety of people and communities, by preventing or managing the adverse effects of hazardous substances and new organisms" (s 4). In relation to hazardous substances, it replaced legislation such as the Dangerous Goods Act 1974, the Explosives Act 1957, the Pesticides Act 1979 and the Toxic Substances Act 1979. [9] Section 5 sets out two principles, and s 6 six relevant matters, which ERMA and others must recognise and provide for in performing their functions under the HSNO Act. The two principles are: (a) safeguarding "the life-supporting capacity of air, water, soil, and ecosystems"; and (b) maintaining and enhancing "the capacity of people and communities to provide for their own economic, social, and cultural wellbeing and for the reasonably foreseeable needs of future generations". [10] Part 5 of the HSNO Act deals with the assessment of hazardous substances and new organisms. Under s 28, persons wishing to import or manufacture a hazardous substance otherwise than in containment must apply to ERMA for approval. As we describe in more detail below, Part 5 goes on to set out the process by which ERMA must deal with applications. Essentially, there is a public notification process, followed (generally) by a public hearing. To facilitate the public nature of the process, ERMA is obliged to keep a register of all applications made to it (s 20(1)), which is to be available for inspection by members of the public during ERMA's ordinary office hours (s 20(3)). [11] Under s 9 of the HSNO Act, the Governor-General may by Order in Council establish a methodology for making decisions under Part 5. ERMA must consistently apply that methodology when making such decisions. The methodology is found in the Hazardous Substances and New Organisms (Methodology) Order 1998.[12] Furthermore, there are wide regulation making powers in s 140, under which numerous sets of regulations have been promulgated, to which ERMA is obliged to adhere. Some will be mentioned in the discussion which follows, as will other specific sections of the HSNO Act.Background: the facts[13] On 19 June 2006 Ancare filed an application with ERMA under s 28 to import or manufacture a hazardous substance, namely MEP 600. The application was on a standard form approved by ERMA. The form asks a series of questions, leaving space below each question for the applicant to complete the answer. In respect of some questions, there is an explanatory note. In both the introduction to the application form and some of the explanatory notes, applicants are directed to deal with confidential information by including it in an appendix. [14] Ancare explained the context of the application in the Executive Summary to the application as follows:This application is being made to gain approval for MEP 600 to be manufactured and released in New Zealand. Products containing the same active ingredients are already on the market, however this formulation has not been notified as a hazardous substance and therefore requires assessment according to the HSNO Act. MEP 600 triggers some of the HSNO thresholds for toxicity and ectoxicity. The main risks associated with this product are during transport and to the user if not handled or stored appropriately, or to aquatic organisms or terrestrial vertebrates in the case of accidental spills or inappropriate disposal. The magnitude of these risks are judged to be minimal as these events are unlikely and in the event that they did occur would be localised and of short duration. These risks will be further controlled by the product labelling including information on the administration to animals (topical and/or internal) and the method of disposal. Therefore the risks resulting from this product will be insignificant.MEP 600 will not pose any economic, social or environmental cost. The introduction of this product to the market will not increase volumes sold, it will simply increase market choice. This increased choice may translate into cheaper prices for the farmer and MEP 600 will also have a number of benefits in terms of animal welfare and increased production.[15] Section 3 of the application form deals with information on the substance which is the subject of the application. The explanatory note to the section notes thatcommercially sensitive information should be attached as an appendix and that, although the application should be cross-referenced to the appendix, it should be capable of being read as a stand alone document which can be publicly released. [16] Under question 3.1 the applicant is required to state "all information necessary to unequivocally identify the substance(s)". Specific classes of information are given as examples. The form says:If there are commercial reasons for not providing full information in the main part of the form, alternative approaches must be discussed with and agreed by [ERMA]. These must include the provision of a unique identifier of some kind.Ancare's response to this question was:The composition of the mixture MEP 600 is confidential. Details of the formulation and components are provided in Appendix 1.[17] In response to a question requiring provision of information on the hazardous properties of the substance(s), Ancare identified MEP 600's hazardous properties by reference to a list of such properties. In respect of those hazardous properties that were triggered, Ancare noted the relevant classification category and criteria (as set out in the Hazardous Substances (Classification) Regulations 2001). In its answer it said:The methodology for determining this status contains confidential composition details and is therefore included in Appendix 1 (Confidential).Ancare then identified the relevant default controls by reference to control codes (comprising letters and numbers) developed by ERMA to enable easy cross- referencing to the relevant regulations. [18] Section 4 of the application form asks a number of questions about the risks, costs and benefits associated with the relevant substance(s). Ancare answered these questions in some detail. Again, this section of the application form reflects the underlying regulations.[19] Section 7 of the application deals with what is to go on the public register. In that context, Ancare identified the name of the substance as "MEP 600" and described the purpose of the application as being:To manufacture and release for use an anthelmintic for ruminants, in a liquid form. Products containing the same active ingredients are already approved in New Zealand for this purpose, however, this formulation is not a notified toxic substance and therefore requires assessment according to the HSNO Act.(An anthelmintic is an agent for treating worms.) [20] ERMA publicly notified the application (as required by s 53(1)(a) of the HSNO Act), and advised the Minister for the Environment, the Ministry of Health and several regulatory bodies of it (as required by s 53(4)). The timetable to which ERMA must work in processing applications is set out in s 59 of the HSNO Act. Under the section ERMA must: (a) publicly notify an application within ten working days of its receipt if it does not utilise the rapid assessment procedure (s 59(1)(a) and (b)); (b) allow 30 working days from the date of public notification for the receipt of submissions (s 59(1)(c)); (c) if submissions are received (and on the assumption that there is to be a hearing), fix a date for a hearing within a further 30 working days (s 59(1)(d)); (d) give the applicant, and every person who has made a submission and stated a wish to be heard, at least 10 working days notice of the commencement date and time and place of the hearing (s 59(1)(e) and (f)); (e) Publicly notify its decision on the application as soon as is reasonably practical, but not later than 30 working days after the conclusion of the hearing.Section 59(5) provides that ERMA may extend or reduce a time requirement, but that is subject to s 59(4), which requires ERMA to be satisfied before it does so either that the applicant and any submitters consent to the change or that any party who has not consented will not be unduly prejudiced by it. [21] On 5 July 2006 ERMA published a "Call for Submissions" in The Pressnewspaper, which summarised a number of applications, including that received from Ancare. It said:The following applications for approval under the Hazardous Substances and New Organisms Act have been publicly notified by ERMA New Zealand: Application HSR06071 by Ancare New Zealand Limited to manufacture and release MEP 600 for use as an anthelmintic for ruminants in liquid form. Date of public notification 5 July 2006, closing date for submissions 16 August 2006. The formal public notice and any further information can be obtained by contacting us at the address below or via our website www.ermanz.govt.nz/consultations/consul-apps.cfm.[22] On 17 July 2006 Wyeth's solicitors wrote to ERMA requesting information under the OIA about MEP 600, including its active ingredient and the chemical structure of that active ingredient (this is the key information). ERMA advised Ancare of Wyeth's information request by letter dated 20 July 2006. The letter said:The information requested all either directly or indirectly seeks the disclosure of the active or inert ingredients in MEP 600. You have identified both the active ingredient and the formulation as confidential, and we therefore require either your authorisation to release this information, or your detailed justification for withholding the information under section 9(2)(b) of the OIA. For further details on the justification required, please see the attached sheet.[23] Section 9(2)(b) of the OIA provides for the withholding of information where the information is in the nature of a trade secret or its disclosure would be likely to unreasonably prejudice the commercial position of the party supplying it. It is relevant in the present context because s 57(1) of the HSNO Act provides:Where, in [ERMA's] opinion, any information which has been supplied to [ERMA] in respect of any application may be able to be withheld undersection 9(2)(b) of the Official Information Act 1982, that information shall not be released to any person when any application is publicly notified.Accordingly in the attached sheet referred to in the extract quoted at [22] above ERMA sought information going to these grounds. [24] Ancare responded by letter dated 27 July 2006. It submitted that the release of the information would disclose a trade secret and unreasonably prejudice its commercial position. It said:There are a number of common excipients and a limited number of actives used in the formulation of veterinary medicines. By revealing the identity of the components in the substance, or by revealing any indirect information that leads to the identity of the components, it is possible to deduce the formulation, and in effect, to release the formulation of this particular substance. Therefore, the release of this information would disclose a trade secret. A significant amount of time, money and effort is invested in the development of this substance. Release of the requested information will result in an unfair advantage to the recipient and jeopardize Ancare NZ Ltd's commercial position.[25] It went on to respond to the specific questions in ERMA's attached sheet as follows:Please identify the prejudice likely to result to your company's commercial position if the information is made available.It is necessary to submit an ERMA application for a substance at the start of the development process – as soon as the final formulation is confirmed. Releasing any detail or information that leads to deduction of the identity of the ingredients, including details on the administration method or proposed packs, to the public (or to interested parties) will inform our competitors exactly what we intend to bring to market next. The release of this information will allow our competitors an opportunity to: 1. bolster the marketing of their products in the same market sector, 2. block the entry of our product into the market by loading up distribution channels with special deals etc, 3. prepare arguments and put negative spin in the market against the new product before it is even released, 4. change/introduce new pack sizes to match new product pack sizes, 5. begin development of copycat products to launch very quickly after the product is released,6. impinge any patent submissions.How likely is it that this prejudice would result from disclosure?We actively monitor the releases from ERMA to try to determine our competitors activities and be prepared to impede the success of any product that may actively compete with one of ours. We also know that our competitors do the same thing – it is a small industry. Therefore it is extremely likely that our competitors actively seek this information or will see this information to make use of it to limit the impact of any new products.Please explain why the prejudice would be "unreasonable".Ancare spends a significant amount of time, money and effort on the development of new formulations (our R&D budget exceeds $3 million per annum). In this industry, formulation development on individual products can cost hundreds of thousands of dollars. Often new developments are combinations of existing molecules that are not always obvious and exploit a niche of the market not identified by competitors. The release of formulation ingredients so early in our development process will allow our competitors to identify this niche, or realise the significance of a new development. This is information that our competitors would not normally have until after product launch. That allows a reasonable timeframe to establish a market and a brand before competitors can follow. Early access to vital information such as this cuts the timeframe considerably. Therefore, this information will result in an unfair advantage to our competitors and a concomitant prejudice to Ancare. The market segment we are operating in is worth $100 million per annum in NZ. New products such as this could expect to initially sell $1–2 million per year. If the market advantage is lost by the arguments listed above, the predicted sales could be half that. This prejudice therefore is unreasonable.Please also explain why disclosure would be so likely to cause the predicted prejudice that it is necessary to withhold it.There are other companies that actively compete in this market and have the technology to develop a similar product very quickly. As discussed above we also know that other companies will act on information – such as active and/or non-active ingredients, application methods and pack sizes to prevent the successful launch of a competing product. There is no way to demonstrate the exact likelihood other than to state the obvious. Ancare is a very innovative company. We develop formulations that many companies have previously believed impossible and we would like to keep our competitive edge. Making formulation information public at such an early stage will significantly impact on that advantage. Therefore, the information requested should be withheld under section 9(2)(b) of the Official Information Act 1982.[26] Following receipt of this letter, also on 27 July 2006, ERMA wrote to Wyeth advising that its request for the release of the key information had been declined (s 57(4) of the HSNO Act). ERMA told Wyeth that the information was being withheld on the ground that its release was likely to prejudice Ancare's commercial position unreasonably (s 9(2)(b)(ii) of the OIA). ERMA did not withhold it on the ground that it would disclose a trade secret (s 9(2)(b)(i) of the OIA), apparently because it considered that that ground was not made out. [27] Then, on 16 August 2006, Wyeth filed submissions with ERMA on Ancare's application, indicating that it wished to be heard in support of its submissions at a public hearing (s 54(2)(c)). On 7 September 2006 Wyeth applied to the Ombudsman for a review of ERMA's decision to withhold the key information. That same day, ERMA advised Wyeth's solicitors that it was proposing to hear Ancare's application on 27 September 2006 and enquired whether it still wished to be heard. Wyeth's solicitors responded on 8 September 2006, requesting that the hearing be postponed until either the key information was released or the outcome of the Ombudsman's review was known. [28] On 8 September 2006 ERMA informed Ancare of Wyeth's request for an adjournment and said:Under section 59(4) the Authority can only extend the time period, for fixing a date for a hearing if it is satisfied that you consent to the waiver; or that the [sic] you will not be unduly prejudiced.Accordingly, could you please advise whether you consent to a waiver of the requirement to commence the hearing within 30 days of the closing date for submissions.(Emphasis in original.)[29] Ancare did not consent. On 12 September 2006 ERMA denied Wyeth's request for an adjournment of the public hearing, on the ground that Ancare did not consent to the waiver of the time requirement and ERMA was not satisfied that Ancare would not be unduly prejudiced by the waiver. On 13 September 2006 ERMA sent a lengthy Evaluation and Review Report (the E&R report) prepared by members of ERMA's staff concerning the application to, among others, Ancare andWyeth's solicitors. Wyeth's solicitors were not provided with the confidential appendices to the E&R report. [30] On 18 September 2006, Wyeth's solicitors emailed ERMA offering to receive any information said to be confidential on the basis of a confidentiality undertaking, a draft of which was attached to the email. They said:Our client, [Wyeth] has made a submission in regard to the Application and wishes to be heard at the hearing. However, you will appreciate that without the allegedly confidential information referred to in the attachedUndertaking, it will be impossible for us to represent our client effectively at the hearing. As you know, we have sought a review by the Ombudsman of ERMA's decision to withhold the allegedly confidential information. However, we understand it is unlikely the Ombudsman will provide its report and view by the date of the hearing. We therefore request, under section 59(3) of the [HSNO Act], that the hearing be postponed until we are able to review the allegedly confidential information or we receive a response from the Ombudsman. As we have previously noted, it will be difficult, if not impossible, to prepare meaningful and substantive submissions for a hearing without access to the confidential information. We believe that if the hearing proceeds and/or a decision is made on the Application without our client having a opportunity to make meaningful submissions (including following assessment by it or an independent expert of that information) then the purpose of the Act will be frustrated and the hearing process empty.We request you to urgently notify us if a postponement of the hearing will not be granted.(Emphasis in original.)[31] In response to a follow up enquiry from ERMA, Wyeth's solicitors advised that they would not convey the precise content of any confidential information to Wyeth, only its general nature. This would be done only so that they could obtain instructions on the nature of the submissions they might make at the hearing. Wyeth's solicitors said that they would probably require the assistance of an independent expert, but he or she would also provide a confidentiality undertaking. The general import of the expert's opinion would be conveyed to Wyeth to the extent necessary to obtain instructions, but not in a way that would reveal the detail of the confidential information.[32] ERMA put this proposal to Ancare, but it was rejected. ERMA advised Wyeth's solicitors of this. They again requested a postponement of the hearing, a request which ERMA rejected. Wyeth's solicitors protested in the following terms:We reiterate our view that we do not believe that a relatively brief postponement to enable our client to properly participate in the process would unduly prejudice the applicant. In our view, the decision regarding a postponement should be made upon the basis of all of the surrounding circumstances, including our client's good faith attempts to obtain the information which it needs to understand what the substance of the Application is, and to make (or not make) substantive submissions accordingly. The regulatory scheme envisages participation of interested parties in this fashion and our client has been effectively denied its right to participation.[33] The hearing took place as scheduled on 27 September 2006 before a Decision Making Committee of ERMA, chaired by Mr Neil Walter (the Committee). Two weeks prior to the hearing, the Committee members had been provided with copies of the application and the E&R report (plus confidential appendices). [34] At the hearing, Wyeth's counsel again requested, both orally and in writing, that the hearing be adjourned and reconvened after Wyeth had been given an opportunity to review the key information. He repeated Wyeth's offer to provide a confidentiality undertaking, as proposed by its solicitors. On behalf of the Committee, Mr Walter refused counsel's request. Wyeth's written and oral submissions were procedural in nature, focussing on the difficulties for it (and the hearing process more generally) from the lack of access to the key information. [35] On 17 October 2006 the Committee approved Ancare's application, subject to controls. [36] Wyeth then issued the present proceedings, in which it was substantially successful. We will deal in more detail with Wild J's reasoning when we address the individual issues before us. At this point, it is sufficient to say that the Judge: (a) quashed ERMA's decision to approve Ancare's application; (b) declared that ERMA had erred in law in relation to its interpretation and application of ss 57(4) and 61(7) of the HSNO Act; and(c) directed ERMA to conduct a re-hearing of Ancare's application and, if Wyeth renewed its request for the key information subject to a confidentiality undertaking, to exercise its discretion in accordance with the Court's interpretation of the relevant provisions of the HSNO Act. [37] On 11 May 2007, shortly before the hearing before Wild J, the Ombudsman released her decision on Wyeth's application for a review of ERMA's decision to withhold the key information. The Ombudsman upheld ERMA's decision, saying:56. While I do not wish to appear to undervalue the importance of public participation in the process of an application under the HSNO Act, I am also aware of the commercial importance attached to the protection of confidential information for the sorts of reasons which I have discussed above. The free flow [of] that information to ERMA is of critical importance to the performance of its functions under the Act. The likelihood that confidential information would be readily released might well be an impediment to the performance of ERMA's functions, which would not be in the public interest. 57. I am not satisfied that Wyeth's arguments relating to the competence of the ERMA to deal adequately with this and other similar applications has been established. If Wyeth considers that the law relating to public participation is inadequate it should take its concerns to the relevant government agencies. 58. It is accordingly my final view that the Key Information may continue to be withheld pursuant to section 9(2)(b)(ii) [of] the Act, and that I have not had brought to my attention any considerations falling within the terms of section 9(1) of the Act which I consider to outweigh the withholding ground identified.Issues on appeal[38] As a result of Ancare's appeal and Wyeth's cross-appeal there are three questions for determination: (a) Did the High Court have jurisdiction under s 126 of the HSNO Act to entertain the appeal? This arises from Ancare's grounds of appeal. (b) Was the key information "information" for the purposes of s 57 of the HSNO Act? This is raised by Wyeth's cross-appeal.(c) Did the High Court err in holding that the limited disclosure proposed by Wyeth was within ERMA's powers and appropriately protected Ancare's commercial position? This arises from Ancare's grounds of appeal. [39] ERMA, although not an appellant, made brief submissions on four points. To the extent necessary, we will address the points it raises in our discussion of the issues just mentioned.Did the High Court have jurisdiction under s 126?[40] The Judge noted (at [43] – [44]) that Wyeth accepted that its appeal did not challenge ERMA's substantive decision of 17 October 2006 but rather focussed on a number of procedural decisions made by ERMA which, it claimed, deprived it of effective participation in the hearing. These were ERMA's decisions: (a) on 5 July 2006 not to publicly notify the active ingredient of MEP 600 or its chemical structure, or enter them in its public register. (b) to withhold the key information from Wyeth, both initially when its request was received and subsequently when it made its confidential undertaking proposal. (c) not to adjourn the hearing of the application. [41] Having recorded the submissions of the parties (at [45] – [57]), the Judge noted the conflicting decisions of the High Court as to whether this sort of appeal permits only challenges to the substance of a decision or whether it permits also process-oriented challenges. Supporting the latter position was Accident Compensation Corporation v District Court at Wellington (2000) 14 PRNZ 507 (HC) at [21] and Phillpott v Chief Executive of the Department of Labour HC WN CIV 2005 485 713 21 October 2005 at [33], [53] and [58]. Supporting the former position was McFarlane v Chief Executive of the Department of Work and IncomeHC AK AP17-PL02 22 July 2002. In McFarlane Harrison J referred to Goddard J'sdecision in Accident Compensation Corporation v District Court and disagreed with it (at [24] – [25]). [42] Albeit with some reservations, the Judge decided that he did have jurisdiction to determine the appeal (at [62] – [63]). He accepted that issues of statutory interpretation were at stake, which could not logically be divorced from ERMA's 17 October decision to grant the application (at [63] – [65]). He said that there was a strong public interest in having these issues of interpretation resolved sooner rather than later, and said that there was no disadvantage or prejudice to either Ancare or ERMA in his dealing with the appeal (at [66] – [69]). The Judge noted the pointless delay and expense that would flow from his dismissing the appeal on jurisdictional grounds (at [70]) and expressed a desire to get to the heart of the matter (at [71]). [43] Mr Upton QC for Ancare argued that Wild J's approach was wrong. He submitted that the decisions under appeal were properly seen as interlocutory or procedural in nature. They were not part of ERMA's substantive decision-making process and should be treated as separate from the substantive decision. He invoked the principles referred to in the decision of this Court in Association of Dispensing Opticians of New Zealand Inc v Opticians Board [2000] 1 NZLR 158 at [34] – [36] (Dispensing Optiicians).Our evaluation[44] We begin by noting two points: (a) No party disputes that the issues raised on the appeal are of public importance. They concern the proper interpretation of the HSNO Act, in particular information requirements and ERMA's powers in dealing with applications. As the structure of the HSNO Act plainly reveals, Parliament intended that there be public scrutiny of applications and public input into their resolution. Against this background, the issues on the appeal have real significance.(b) Wyeth is, of course, a competitor of Ancare. It may be that it has an interest in using the statutory processes to make it more difficult for Ancare to introduce a new product to the market. But that is of limited significance, because a competitor may, as the Judge recognised (at [83]), advance the public interest along with its commercial interests. Indeed, in this as in other areas (for example, in competition law), Parliament seems to have structured the relevant legislation in a way that recognises and seeks to take advantage of this feature. Accordingly, the fact that Wyeth is a competitor does not diminish the significance of the issues which it raises or cast doubt on its interest in participating in a meaningful way in ERMA's processes. [45] We accept that not every procedural decision made by ERMA in the course of dealing with an application will provide an arguable basis for an appeal on a point of law against the substantive decision on that application. This follows from this Court's discussion in Dispensing Opticians at [34] – [36], albeit that that discussion was in the context of an unsuccessful attempt to strike out an appeal against an interlocutory decision in judicial review proceedings. The Court there distinguished between different types of interlocutory decision. Some are essentially matters of case management which do not affect the rights or liabilities of the parties; others are much more significant, in the sense that they may substantially affect the shape of the hearing. [46] In the present case Wyeth alleges that, as a result of ERMA's approach to the key information, it has been denied the opportunity to participate in any effective way in the hearing, contrary to Parliament's intention. Wyeth alleges that ERMA's approach is erroneous as a matter of law and permeated its decision-making, giving rise to a fundamental breach of the rules of natural justice. (In terms of theDispensing Opticians categorisation, the withholding of the key information affected the shape of the hearing.) We see no reason why this issue should not be raised by way of an appeal on a point of law against the substantive decision rather than by way of judicial review proceedings. If there has been a breach of the rules of natural justice, the substantive decision will be tainted by illegality.[47] This approach is consistent with earlier decisions of this Court. For example, in Christchurch District Licensing Agency Inspector v Karara Holdings LtdCA 178/02 13 June 2003, the Court noted that the respondents had been granted leave to add an additional question of law to be determined on the appeal, namely whether there had been a breach of natural justice by the Licensing Authority in the way it conducted a hearing (at [46]). When discussing the interrelationship between judicial review proceedings and the ability to seek leave to appeal on a point of law in Zaoui v Attorney-General (No 2) [2005] 2 NZLR 690 (CA), Glazebrook J observed that judicial review is "only available for material errors of law and leave to appeal would almost certainly be granted if such errors were made" (at 720). It follows, then, that we do not agree with Harrison J's observations in McFarlane (see [41] above). [48] Further, as a matter of principle we see much to commend our preferred approach. We consider that there is little benefit in compelling parties who are dissatisfied with the type of procedural decision at issue in this appeal to commence judicial review proceedings to challenge them as they arise rather than waiting to raise them on appeal should that prove necessary. [49] Accordingly, we agree with Wild J that he had jurisdiction under s 126(1) to deal with the issues which Wyeth raised.Was the key information "information" for the purposes of s 57?[50] Section 57 of the HSNO Act places an obligation on ERMA not to release information when an application is publicly released where, in its opinion, that information "may be able to be withheld under s 9(2)(b)" of the OIA. Section 56 provides that any information withheld from any person "in accordance with s 9(2)(b)" of the OIA may be considered by ERMA in reaching a decision under the HSNO Act. [51] Wild J held that the key information was "information" within the ordinary everyday meaning of that word and accordingly fell within s 57 (at [124]).[52] Mr Brown QC for Wyeth submitted that, because the HSNO Act reveals a clear legislative intention favouring both public accessibility to information and meaningful public participation in the approvals process, it made no sense to interpret s 57 as permitting ERMA to withhold the identity of the relevant hazardous substance, in this case the active ingredient of MEP 600. Rather, the register of applications "should record for public accessibility the identity of the [relevant] hazardous substance in terms of its chemical or common name and/or biological nature". [53] To understand the basis for this submission, we must refer to several further provisions of the HSNO Act. [54] We begin with s 28, the section under which Ancare made its application. Section 28(2) provides:Every application shall be in an approved form and shall include– (a) the unequivocal identification of the substance and its properties; and (b) information on all the possible adverse effects of the substance on the environment; and (c) information on the intended uses of the substance throughout the life cycle of the substance; and (d) information on methods of disposal of the substance; and (e) information on all occasions where the substance has been considered by the government of any prescribed State or country or any prescribed organisation and the results of such consideration; and (f) such other information as may be prescribed. (Emphasis added.)[55] It will be recalled that question 3.1 in the application form (see [16] above) requires an applicant to provide "all information to unequivocally identify the substance(s)". Obviously this reflects the language of s 28(2)(a). The public register provision, s 20, contains slightly different language. Under that section ERMA is required to keep a register of all applications made to it, which must specify (among other things) "a sufficient description of the substance to uniquely identify [it]"(s 20(2)(b)). Mr Brown submitted that these provisions, like other provisions of the HSNO Act (ss 31(2)(a), 34(2)(c), 38A(2)(c), 40(2)(a)(i) and 40(2)(b)(i)), required explicit identification of the hazardous substance, not a label which conveyed nothing (like MEP 600). [56] In this context, Mr Brown relied on the definition of "identification" in s 2(1) of the HSNO Act. It provides:[I]dentification means the provision of any information about a substance or organism which– (a) clearly identifies the chemical or biological nature of the substance or organism: (b) specifies the nature and degree or type of hazard intrinsic to the substance or organism: (c) describes precautions to be taken by persons managing hazardous substances to avoid injury to people or environmental damage: (d) directly or indirectly aids in managing any hazardous effect of a hazardous substance: (e) identifies and specifies the means of contacting any person knowledgeable in the management of the substance.[57] This brings us on to the provisions dealing with ERMA's hearing process, upon which Mr Brown placed considerable emphasis. Section 60 of the HSNO Act provides that ERMA does not need to hold a hearing unless one of three circumstances applies: (a) ERMA considers a hearing is necessary; (b) The applicant has requested a hearing in writing; or (c) A person making a submission has indicated that he or she wishes to be heard. [58] Section 61 deals with hearings. Of particular relevance in the present context are s 61(3), (7), (8) and (9). They provide:61 Provisions relating to hearings (3) For the purpose of considering any application, [ERMA] shall have the same powers as are conferred on a Commission of Inquiry by the Commissions of Inquiry Act 1908; and sections 4, 4B, 4D, 6, 7, 9, 11, and 12 of that Act shall apply accordingly. (7) [ERMA] shall hold any hearing of a publicly notified application in public and shall establish a procedure that is appropriate and fair in the circumstances and may– (a) permit cross-examination; or (b) permit questions in clarification; or (c) permit only the members of [ERMA] to question any person. (8) At the hearing the applicant and any person who made submissions and stated that they wished to be heard may speak (either personally or through a representative) and call evidence. (9) Where any person who has stated that he or she wished to be heard fails to appear at the hearing, [ERMA] may nevertheless proceed with the hearing if it considers it fair and reasonable to do so.[59] Mr Brown argued that the public hearing processes would be undermined if ERMA was able to withhold information as to the active ingredient of MEP 600 from public accessibility. Rather, that information should necessarily be disclosed in the application and on the register.Our evaluation[60] We agree with Wild J that ERMA was entitled under s 57 to withhold the key information from the publicly accessible part of the application form and therefore from the register. We agree for four reasons. [61] First, ss 56 and 57 are expressed in unqualified language. We do not agree that, as a matter of construction, this unqualified language must be qualified as a result of the requirements of s 20 for entry onto a publicly accessible register or the need for a public hearing. Adopting the approach advanced by Mr Brown would result in the practical significance of ERMA's power to withhold information unders 57 being limited greatly. The presence of s 56 shows that Parliament anticipated that information withheld under s 57 might be material to the decision that ERMA was required to make. As a consequence, Parliament clearly contemplated that submitters may not have access to all material information. [62] Second, we do not consider that the definition of the word "identification" advances matters, for two reasons: (a) Section 20(2)(b) requires a sufficient description of the substance "to uniquely identify it". As the definition of "identification" does not contain the words "and identify has a corresponding meaning", there appears to have been no intention to apply the extended meaning to "identify" (compare the definition of "explosive" in s 2(1), which does contain the words "and explosion has a corresponding meaning".) Section 20 is simply a direction to ERMA about keeping a public register. The need for a unique identifier in that context seems obvious. MEP 600 performs that function, although it is not, we accept, informative about the makeup of the substance. (b) Although s 28(2)(a) uses the word "identification", the extended meaning in the definition seems inappropriate in light of the subsequent paragraphs in s 28(2). For example, the information referred to in s 28(2)(b) would fall within the definition and therefore within s 28(2)(a) if the extended meaning applied. In any event, Ancare's application did explicitly identify the relevant hazardous substance. It is the fact that it did so only in the confidential appendix that gives rise to the current dispute. [63] Third, while the identity of the particular substance may not have been publicly disclosed, the public part of the application does identify important information about MEP 600, as Mr Murray for ERMA argued. For example, it identified the substance as a drench, and noted its hazardous properties and the relevant default controls, in each case by reference to the relevant regulatory classification. Accordingly, members of the public had sufficient information tounderstand issues such as the risks posed by the substance. Further, the E&R report contained a detailed discussion of matters such as: (a) the potentially significant risks to the environment, to human health and safety, to society and community and to economic interests; (b) the types of control that should be imposed; and (c) the overall evaluation of risks, costs and benefits. So somebody wishing to participate in the hearing did have a good deal of information available to him or her. In this context, it is also relevant that E&R reports are prepared for the relevant ERMA decision-making committee by persons with relevant scientific expertise, and the decision-making committee itself will also contain such expertise. Further, under s 58(1) ERMA has the ability to commission reports or obtain advice from independent experts. In that way ERMA's processes ensure that an applicant's scientific claims are subjected to independent scrutiny. ERMA is not dependent on public input in that respect. [64] What this suggests is that the interest of the public under the HSNO Act is not so much in the precise makeup of the hazardous substance but in the risks it poses and the ways in which, if it were to be approved, those risks would be mitigated or managed. As we have said, those issues must be identified in the public part of the application, so that the public will be able to make meaningful submissions on them. [65] Fourth, as the Ombudsman recognised in her letter of 17 May 2007, the active ingredient of a formulation such as MEP 600 is likely to be valuable commercial information and compelling release of it at this stage of the regulatory process is likely to cause significant prejudice to an applicant. It seems to us unlikely that Parliament intended any such outcome. [66] Finally, before leaving the cross-appeal we should note that Mr Brown relied on the Hazardous Substances (Identification) Regulations 2001. He pointed out thatthey contained detailed identification requirements and submitted that they supported a requirement to disclose the key information. But those regulations were made under s 76(1)(b) of the HSNO Act. That section is found in Part 6, which deals with the control of hazardous substances rather than with the application process. The regulations address the obligations of those who supply or have charge of hazardous substances, not what must be included in the public part of an application to ERMA. [67] Accordingly, we agree that the key information was "information" for the purposes of ss 56 and 57.Did the High Court err in concluding that ERMA had the power to, and should have, accepted Wyeth's confidentiality undertaking?[68] Wild J held that ERMA should have accepted the confidentiality undertaking because this was the only way that Wyeth could participate meaningfully in the hearing and it was sufficient to protect Ancare's commercial interests (at [115]). The Judge relied in particular on s 61(3) of the HSNO Act and also found support in s 59. He said:[117] Mr Murray submitted that the HSNO Act does not provide for limited disclosure, for example on confidentiality undertakings. He submitted that such undertakings would be a matter of private law between the parties, had they been accepted. I do not accept that. It involves interpreting s 57(4) of the HSNO Act as restricting ERMA to the stark alternatives of a complete disclosure of confidential information, or a complete withholding of it. I accept that there is nothing explicit in s 57(4) mandating disclosure upon terms. But nor, in my view, is there anything proscribing that. I have not overlooked s 61(3) which gives ERMA "the same powers as are conferred on Commissions of Inquiry by the Commissions of Inquiry Act 1908; and sections 4, 4B, 4D, 6, 7, 9, 11 and 12 of that Act shall apply accordingly". Section 4C(3) of the Commissions of Inquiry Act is not one of the sections listed there. It authorises a Commission, of its own motion or upon application, to: order that any information or particulars, or a copy of the whole or any part of any paper, document, or record, furnished or produced to it be supplied to any person appearing before the Commission, and in the order impose such terms and conditions as it thinks fit in respect of such supply and of the use that is to be made of the information, particulars, or copy. [118] Although this power is not amongst the particular powers identified in s 61(3), I take the view that it is a power within the general words in s 61(3) "the same powers as are conferred on a Commission if Inquiry by theCommissions of Inquiry Act 1908". Those general words are surely intended to have force and meaning, and I do not regard the particularisation that follows as derogating from that meaning. [119] I find further support for this view from s 59 of the HSNO Act. It is a curious provision that has as its marginal note "Time limits and waivers". Buried within it is this: "A person may apply to [ERMA] to give a direction concerning the terms, including terms as to adjournment, costs or any other matters, on which any information will be supplied" (s 59(3)(b)). This general power is clearly broad enough to authorise ERMA to order limited disclosure by direction as to the terms on which information may be supplied to (and held by) the applicant. (Emphasis in original.)[69] Mr Upton argued that Wyeth did not need to know the key information, as it had access to sufficient information regarding the properties of MEP 600 to enable it to participate effectively at the hearing. To compel Ancare to disclose the key information to its competitor would, he argued, severely prejudice Ancare's interests while not meaningfully assisting Wyeth's submissions. [70] Mr Brown submitted that the starting point of analysis was ss 4 – 7, which deal with the purpose of the HSNO Act and the approach to be adopted under it. These emphasised, he said, the protection of the environment and the health and safety of the people of New Zealand. He placed heavy emphasis on the requirement in s 61(7) that ERMA hold any hearing of a publicly notified application in public as pointing to public accessibility of the key information. The approval process should be as transparent as possible. While Wyeth may have been able to make an informed guess as to the composition of MEP 600, this did not remove the need for ERMA to exercise its statutory discretion under s 61(7). That is, ERMA should not simply have accepted Ancare's preference as to disclosure but should have determined for itself whether a confidentiality undertaking would be "appropriate and fair in the circumstances" to address Ancare's concern about its commercial position. [71] ERMA's stance was that Wyeth could still have participated in a meaningful way in the hearing of Ancare's application given its knowledge of drenches and the information that was disclosed in Ancare's application and in the E&R report. In relation to Wild J's finding that ERMA had the power to utilise confidentiality undertakings to release information protected by s 9(2)(b) of the OIA, Mr Murraysubmitted that it was not clear whether the Judge considered the source of this power to be s 57(4) or s 61(7). If the latter, ERMA would be required to operate two discrete disclosure regimes – one under the OIA as provided for in s 57, and one through the public hearing procedures in s 61, which could include release of protected information through confidential undertakings. Mr Murray submitted that if ERMA did indeed have this power, it was better linked to s 61(7) than to s 57(4).Our evaluation[72] We begin by saying that we consider that the confidentiality undertaking approach adopted by the Judge is a sensible and pragmatic way of balancing the competing interests at stake in this context. Despite that, we consider that ERMA does not have the power to require parties such as Ancare to make protected information available to members of the public on the basis of confidentiality undertakings (unless, of course, such parties agree to that approach). In particular, we do not agree with the emphasis that the Judge gave to ss 61(3) and 59(3) of the HSNO Act. [73] First, as the Judge noted (at [117]), s 61(3) omits any reference to s 4C of the Commissions of Inquiry Act. We do not agree with the Judge that this can simply be ignored. We consider that s 4C was not included because the HSNO Act has its own mechanisms for dealing with confidential information, namely ss 55 and 57. Accordingly, s 4C does not apply to ERMA. [74] Second, we do not agree that s 59 has the significance accorded to it by the Judge. Section 59(3) enables a person to apply to ERMA for directions concerning, among other things, the provision of information. It is essentially a case management provision, rather than a provision conferring jurisdiction to supply confidential information on terms. Whether or not information will be provided or withheld is determined by reference to other provisions of the HSNO Act, in particular ss 55 and 57. [75] To explain these points further, the HSNO Act provides for the protection of trade secrets and confidential information in two ways, namely through s 57, whichincorporates the OIA procedures, and through s 55(3) – (4B), which incorporate confidentiality provisions from the Medicines Act 1981 and Part 6 of the Agricultural Compounds and Veterinary Medicines Act 1997 (the ACVM Act). The HSNO Act also permits ERMA to take account in its decision-making of information which has been withheld under the OIA (s 56). We consider that the explicit identification of these mechanisms supports the view that ERMA has no power to release confidential information subject to confidentiality undertakings over the objection of the person who provided the information. [76] We have already referred to s 57(1). It permits ERMA to withhold information which, in its opinion, may be able to be withheld under s 9(2)(b) of the OIA Act. Sections 57(2) and (3) set out how ERMA is to deal with requests for such information, and s 57(4) confers a power to release or withhold information "in accordance with the [OIA]" if the conditions in subsections (2) and (3) are met. That process, coupled with s 56, is inconsistent with the notion that ERMA has the power to order that confidential information be provided to some or all members of the public under confidentiality undertakings. No such process is provided for in the OIA, and it is difficult to see how ERMA could police or enforce such undertakings (for example, it has no power in relation to contempt). Further, it is difficult to see how ERMA could provide access to some members of the public wishing to make submissions and not to others. [77] Turning to s 55, under s 55(4) ERMA has the powers of the Minister of Health under ss 23A – 23C of the Medicines Act where it holds information of the type referred to in s 54(3). Section 54(3) applies where three conditions are met – ERMA holds information relating to an application in respect of a hazardous substance, the substance is the subject of an "innovative medicine" application under the Medicines Act and the information includes a trade secret or commercially valuable information that would be likely to be diminished by disclosure. Where those conditions apply, ERMA: (a) Must ensure that the confidential information is kept confidential for a period (the protected period) (ss 23A – 23C of the Medicines Act and s 55(4)(a) of the HSNO Act).(b) May disclose the information to any prescribed person or organisation or prescribed class of persons or organisation (s 55(4)(b)). The prescribed persons or organisations are those referred to in regulations made under s 55(7). (c) Must provide a summary of the effects of any relevant substance where the application for approval is required to be publicly notified (s 55(4)(c)). [78] There are similar provisions in respect of confidential information relating to substances which are the subject of an innovative agricultural compound application under Part 6 of the ACVM Act (s 55(4A) and (4B)). In that case, ERMA has the powers of the "Director-General" (i.e. the Chief Executive of the responsible Ministry). [79] Under these provisions, then, ERMA may withhold information similar to the key information in this case. Like s 56, they show that Parliament contemplated that ERMA could consider, in determining a particular application, material information which had been withheld from interested parties. [80] Under s 55(4)(c) and (4B)(c) it is sufficient that ERMA provide interested parties with a summary of the effects of any relevant substance. In essence, the same position applies where information such as the key information in the present case is withheld under s 57. While a public submitter will not have the key information, he or she will have knowledge of the relevant substance's effects and the proposed controls, because those aspects will be identified in the application by reference to the regulatory classification scheme. [81] Further, it is important in this context to recall the point made earlier: that ERMA has the capacity to evaluate an applicant's scientific claims. It does not need to rely on members of the public for that. ERMA has its own scientific resources and also has the ability to seek an independent report or advice on an application. Where it does so ERMA is entitled to provide the consultant with all information (including confidential information) provided by the applicant. This follows fromthe use of the words "including a review of any information provided by the applicant" in s 58(1)(a) (emphasis added). Accordingly, from ERMA's perspective at least, withholding the key information does not mean that its ability to perform its function is impaired. [82] It is also important to recall that members of the public wishing to make submissions will have available to them information about the risks posed by the hazardous substance and the controls that are proposed. As we have already said, it is this which is the critical information for those wishing to make submissions. [83] Accordingly we find for Ancare on this aspect of the appeal. As a consequence we reinstate ERMA's decision allowing Ancare's application subject to conditions.Decision[84] We allow the appeal and dismiss the cross-appeal. The first respondents must pay the appellant costs for a standard appeal on a band B basis, together with usual disbursements. We certify for two counsel.Solicitors: Lowndes Associates, Auckland for Appellant Baldwins Limited, Auckland for First Respondent ERMA New Zealand, Wellington for Second Respondent