Secretary Department of Health and Ageing v iNova Pharmaceuticals

RELEVANT STATUTORY PROVISIONS 3 The FOI Act was amended by Act No. 51 of 2010. The relevant amendments did not become effective until after the decision to which this proceeding relates. The references in these reasons are to the FOI Act as it was in force prior to those amendments. 4 One of the objects of the FOI Act is to extend, as far as possible, the right of the Australian community to access information in the possession of the Commonwealth government, by creating a general right of access to information in documentary form in the possession of departments, limited only by exceptions and exemptions necessary for the protection of essential public interests and the private and business affairs of persons in respect of whom information is collected and held by departments. The pivotal provisions of the FOI Act are s 11 and s 18. Section 11(1) provides that every person has a legally enforceable right to obtain access, in accordance with the FOI Act, to a document of an agency, other than an exempt document. Section 18(1) provides that, where a request is made by a person to an agency for access to a document of the agency, the person must be given access to the document. However, under s 18(2), an agency is not required to give access to a document at a time when the document is an exempt document. The Department is an agency for the purposes of the FOI Act. An exempt document is, relevantly, a document that is exempt by virtue of a provision of Part IV of the FOI Act. 5 Section 24 of the FOI Act deals with requests that may be refused in certain cases. Relevantly, s 24(5) provides that an agency may, in certain circumstances, refuse to grant access to documents in accordance with a request, without having identified any or all of the documents to which the request relates. The circumstances are that: it is apparent from the nature of the documents as described in the request that all of the documents to which the request is expressed to relate are exempt documents, and either it is apparent that no obligation would arise to grant access to an edited copy of the document or it is apparent, from the request or as a result of consultation, that the person would not wish to have access to an edited copy of the document. The agency need not, in such circumstances, specify the provision or provisions of the FOI Act under which the document is claimed to be an exempt document. 6 Section 24A deals with the refusal of requests if documents cannot be found or do not exist. Under s 24A, an agency may refuse a request for access to a document if all reasonable steps have been taken to find the document and the agency is satisfied either that the document is in the agency's possession but cannot be found, or that the document does not exist. There is no mandatory requirement in s 24A as to the manner in which such a refusal is to be communicated to a person making a request. 7 Section 25, which is of critical importance in the present proceeding, deals with information as to the existence of certain documents. Under s 25(1), nothing in the FOI Act is to be taken to require an agency to give information as to the existence or non-existence of a document where such information would, if included in a document of an agency, cause such a document to be an exempt document by virtue of s 33, s 33A or s 37(1). Section 33 deals with documents affecting national security, defence or international relations, s 33A deals with documents affecting relations with States and s 37 deals with documents affecting enforcement of law and protection of public safety. Section 37(1) is of particular relevance in the present proceeding, and I shall say something more about it below. 8 Section 25(2) provides that, where a request relates to a document that is, or if it existed, would be, of a kind referred to in s 25(1), the agency may give notice in writing that the agency neither confirms nor denies the existence, as a document of the agency, of such a document, but that assuming the existence of such a document, it would be an exempt document under s 33, s 33A or s 37(1). Where s 25 is invoked, the agency has no obligation to make any attempt to identify documents that fall within the relevant request. Rather, a response of the kind contemplated by s 25 can be made solely on the basis of the form of the request. 9 Section 26 of the FOI Act regulates the extent to which an agency is required to give reasons for a decision made under the FOI Act. Section 26 deals with the giving of reasons for, and other particulars of, a decision. While s 13 of the Administrative Decisions (Judicial Review) Act 1977 (Cth) imposes an obligation on a decision maker in certain circumstances to give reasons for the decision, s 13 does not apply to a decision referred to in s 26. 10 Under s 26(1), where, in relation to a request, a decision is made relating to a refusal to grant access to a document in accordance with the request, the decision maker must cause the applicant to be given notice in writing of the decision. Relevantly, the notice must: state the findings on any material question of fact, referring to the material on which those findings were based, and state the reasons for the decision, state the name and designation of the person giving the decision, and give to the applicant appropriate information concerning rights of review of the decision and the procedure for the exercise of those rights. 11 Where a notice is given under s 25(2), s 26 applies as if a decision to give such a notice were a decision referred to in s 26 and the decision is, for the purposes of internal review, deemed to be a decision refusing to grant access to the document in accordance with the request, for the reason that the document would, if it existed, be an exempt document under s 33, s 33A or s 37(1), as the case may be. 12 Section 26(2) is also of critical importance in the present proceeding. Section 26(2) provides that a notice under s 26 is not required to contain any matter that is of such a nature that its inclusion in a document of an agency would cause that document to be an exempt document. Thus, s 26(2) ensures that any notice of a decision to refuse to grant access will not contain information that is of such a nature that the notice itself would become an exempt document. It is significant that s 26(2) does not adopt the limitations found in s 25(1) and s 25(2). That is to say, s 26(2) does not refer just to an exempt document that is an exempt document by virtue of s 33, s 33A or s 37(1). 13 Part IV of the FOI Act, which consists of ss 32 to 47A inclusive, deals with exempt documents. Reference has already been made to ss 33 and 33A, the precise terms of which are not presently relevant. The other provisions that have relevance to the present proceeding are ss 37(1)(a), 40(1)(d), 43(1)(b) and 45(1). Under s 37(1)(a), a document is an exempt document, relevantly, if its disclosure under the FOI Act would, or could be reasonably expected to, prejudice the enforcement or proper administration of the law in a particular instance. Section 40(1) is directed to an end similar to that of s 37(1)(a). Under s 40(1)(b), a document is an exempt document if its disclosure would, or could reasonably be expected to, prejudice the attainment of the objects of particular tests, examinations or audits conducted or to be conducted by an agency. 14 Section 43 deals with documents relating to business affairs. Under s 43(1)(b), a document is an exempt document if its disclosure would disclose any information having a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed. Finally, s 45 deals with documents containing material obtained in confidence. Under s 45(1), a document is an exempt document if its disclosure would found an action, by a person other than an agency or the Commonwealth, for breach of confidence. 15 Sections 53 to 56 of the FOI Act inclusive deal with the internal review of decisions made under the FOI Act. Section 54(1) provides, in general terms, that, where a decision of a particular character has been made in relation to a request to an agency, the applicant may request a review of the decision. Where an application for a review of a decision is made under s 54(1), the agency must, as soon as practicable, arrange for a person, not being the person who made the decision, to review the decision and make a fresh decision. Section 26 applies to a decision made under s 54. 16 Section 55 deals with applications to the Tribunal. Section 55(1)(a) relevantly provides that an application may be made to the Tribunal for review of a decision refusing to grant access to a document in accordance with a request. Where, in relation to such a decision, a person is or has been entitled to apply under s 54 for a review of the decision, that person is not entitled to make an application under s 55(1) in relation to that decision, but may make such an application in respect of the decision made on a review under s 54(1). 17 Under s 58(1) of the FOI Act, the Tribunal has power, in addition to any other power, to review any decision that has been made by an agency in respect of a request and to decide any matter in relation to the request that, under the FOI Act, could have been or could be decided by an agency. Any decision of the Tribunal under s 58 has the same effect as a decision of the agency. However, under s 58(2), where it is established that a document is an exempt document, the Tribunal does not have power to decide that access is to be granted to the document, so far as it contains exempt matter. 18 Section 28 of the AAT Act provides, in general terms, that, if a person makes a decision in respect of which an application may be made to the Tribunal for review, any person who is entitled to apply to the Tribunal for a review of the decision may request the person who made the decision to give to the applicant a statement in writing setting out the findings on material questions of fact, referring to the evidence or other material on which those findings were based and giving the reasons for the decision. However, s 62(1) of the FOI Act provides that, where, in relation to a decision in respect of a request, an applicant has been given notice under s 26 of the FOI Act, s 28 of the AAT Act does not apply to the decision. On the other hand, s 62(2) provides that, if the Tribunal considers that a notice furnished under s 26 does not contain adequate particulars of the matters referred to in s 26, the Tribunal may make a declaration accordingly. Where the Tribunal makes such a declaration, the person responsible for furnishing the notice under s 26 must furnish an additional notice containing further and better particulars in relation to matters specified in the declaration made by the Tribunal. 19 Section 43(1) of the AAT Act provides that, for the purpose of reviewing a decision, the Tribunal may exercise all the powers and discretions that are conferred by any relevant enactment on the person who made the decision. On review of a decision, the Tribunal must make a decision: affirming the decision under review, varying the decision under review, or setting aside the decision under review and either making a decision in substitution for the decision so set aside or remitting the matter for reconsideration in accordance with any directions or recommendations of the Tribunal. 20 Under ss 43(5A) and 43(5B) of the AAT Act, a decision of the Tribunal comes into operation forthwith upon the giving of the decision. However, the Tribunal may specify in a decision that the decision is not to come into operation until a later date specified in the decision and, where a later date is so specified, the decision comes into operation from that date. Section 43(5C) makes provision for the extension of any stay of the decision under review until any appeal to the Federal Court has been determined or until the end of the period within which a party to the proceeding may appeal from the Tribunal's decision to the Federal Court.

THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS 21 Pharmaceutical products and therapeutic goods marketed in Australia must be listed on the Register. When a product is listed on the Register, some details of the product are made public, including the company that applies for listing (the Sponsor). Once a product is listed on the Register, the Sponsor may apply for the product to be listed in a schedule (the Benefits Schedule) maintained in connection with the Pharmaceutical Benefits Scheme (the Benefits Scheme). Products listed on the Benefits Schedule are dispensed to patients at a price subsidised by the Commonwealth government. Listing a product on the Benefits Schedule makes the product more attractive for doctors and patients, because the patient pays a lower price than would be paid if the product were not listed on the Benefits Schedule. 22 Two categories of products are listed on the Register, namely, products for which the Sponsor is required to provide detailed evidence supporting claims of quality, safety and efficacy for intended use (Originator Products) and products for which the Sponsor is not required to provide such evidence (Generic Products). However, a Generic Product must contain the same amount of the same active pharmaceutical ingredient as a corresponding Originator Product and, where the Generic Product is absorbed, it must be metabolised and excreted in the same way and at the same rate as a corresponding Originator Product. A Generic Product that meets those criteria is described as the bioequivalent of the Originator Product. Where the Sponsor of a Generic Product can demonstrate that the Generic Product is the bioequivalent of a relevant Originator Product, the Sponsor of the Generic Product can rely on the information supplied to the TGA by the Sponsor of the Originator Product in support of its application for listing of the Generic Product on the Register. 23 Under s 99ACB of the National Health Act 1953 (Cth) (the Health Act), once a generic medicine is listed on the Benefits Schedule, there is a 12.5% reduction in the subsidised manufacturer's price for the Originator Product and all the bioequivalent Generic Products listed on the Benefits Schedule. That reduction will be 16% from 1 February 2011.

iNOVA'S REQUEST FOR ACCESS TO DOCUMENTS 24 iNova is an Australian owned and operated pharmaceutical company. It markets consumer health care and specialty prescription products in Australia and overseas. iNova's products include a product containing the active ingredient imiquimod and products containing the active ingredient phentermine. Imiquimod is the subject of a patent granted to iNova. The patent expires in 2013. Patents granted to iNova in relation to phentermine have now expired. iNova's product containing imiquimod is called Aldara. Aldara is listed on the Register and is also listed on the Benefits Schedule. iNova's products containing phentermine are called Duromine and Metermine. Duromine is listed on the Register but not on the Benefits Schedule. 25 On 22 October 2009, iNova made two requests to the Secretary under the FOI Act. The requests were in relevantly identical terms, except for the reference to imiquimod or phentermine. Each requested a copy of any correspondence received by the TGA accepting into evaluation applications to register a product containing the active ingredient imiquimod or the active ingredient phentermine, as the case may be, made in 2008-2009 by Sponsors other than iNova. Ultimately, the Secretary, following internal review under s 54 of the FOI Act, responded to the requests by letters of 7 May 2010. 26 The letters of 7 May 2010 were provided following a decision by the Tribunal to remit the original decisions to the Department for further consideration pursuant to s 42D of the AAT Act. Under s 42D(1), the Tribunal may, at any stage of a proceeding for review of a decision, remit the decision to the person who made it for reconsideration of the decision by that person. The Tribunal took that action following submissions from the parties on the hearing of a preliminary question as to whether the Department has power to make a determination neither confirming nor denying the existence of documents in response to a request under the FOI Act. It became apparent, in the course of that hearing, that the Secretary relied, in part, on grounds to justify the decisions that were different from those stated in the original determinations. 27 Each of the letters of 7 May 2010 said that a decision had been made to refuse access to any document fitting the description in the relevant request that may be in the possession of the Department, without informing iNova whether or not any such document is in the Department's possession. In each case, the decision maker was stated to be Dr Ruth Lopert, the principal medical adviser in the TGA. The proceeding before the Tribunal was conducted on the basis that the letters of 7 May 2010 were the relevant notices under s 26 of the FOI Act in relation to the decisions to refuse access to any documents and to decline to give information as to the existence or non-existence of the documents sought. 28 In the case of imiquimod, Dr Lopert said that the basis for her decision to refuse access, and to notify iNova that she neither confirmed nor denied the existence of the documents requested, was that the documents, assuming they existed, would be exempt under ss 37(1)(a), 40(1)(d), 43(1)(b) and 45 of the FOI Act. The letter said that Dr Lopert had decided not to inform iNova of the existence or non-existence of the documents sought because to give information as to the existence or non-existence of the documents sought would, if included in the letter, cause the letter to be an exempt document by virtue of those provisions. The letter concerning phentermine was in relevantly identical terms except that reference was made only to ss 43(1)(b) and 45(1) as the basis for any document being an exempt document. Specifically, no reference was made to s 37(1) in the case of phentermine.

THE TRIBUNAL'S DECISION 29 The Tribunal formulated the following issues for its determination: whether the Secretary has power to decide to refuse access to documents and give notice under s 26 in respect of that decision, without revealing whether any of the documents requested are in the possession of the Department; whether information as to the existence or non existence of any document fitting the description of the documents requested would, if included in a notice under s 26, cause the document to be exempt:

• in the case of imiquimod, under ss 37(1)(a), 40(1)(d), 43(1)(b) or 45;
• in the case of phentermine, under s 43(1)(b) or s 45(1); and whether a document fitting the description of the documents requested is exempt:
• in the case of imiquimod, under ss 37(1)(a), 40(1)(d), 43(1)(b) or 45;
• in the case of phentermine, under s 43(1)(b) or s 45(1). 30 The Tribunal concluded that the wording of s 25 indicates that a "neither confirm nor deny response" can only be made in the limited circumstances outlined in that section, namely, where, assuming a document exists, it would be exempt under s 33, s 33A or s 37(1). The Tribunal considered that, if s 26(2), of itself, empowered such a response, s 25 would be otiose and would have no practical functions. Accordingly, the Tribunal found, the decisions under review should be set aside because there was no power to give a "neither confirm nor deny response" to iNova's request for access in relation to phentermine on the ground that, assuming the documents existed, they would be exempt under s 43(1)(b) or s 45. However, in relation to the request concerning imiquimod, it was necessary for the Tribunal to determine whether the putative documents would be exempt under s 37(1)(a) and, if so, whether disclosure of the existence in the notice under s 26 would cause that notice itself to be exempt. 31 Dr Lopert determined that the documents in relation to imiquimod were exempt under s 37(1)(a) on the basis that disclosure would be reasonably likely to prejudice the proper administration of the Health Act as it relates to the Benefits Scheme. Dr Lopert considered that the administration of law and policy for the Commonwealth government's subsidy for costs of medicines and the introduction of generic medicines into the Australian market, with the subsequent savings to the government, fell within the term administration of law in s 37(1)(a). She observed that iNova's request sought documents concerning applications to list medicines on the Register and observed that listing on the Benefits Schedule of a Generic Product would have a significant impact on the cost to the Commonwealth of subsidising the cost of medicines. She considered that the disclosure of the information requested would prejudice the proper administration of the law in the particular instance, in that there was a real likelihood that the information would be used to obtain a financial advantage against the Commonwealth in the sale of certain medicines under the Benefits Scheme, thereby prejudicing the administration of the Health Act. 32 It was common ground that iNova's request for access to documents concerning imiquimod would include applications for the listing of medicines on the Register. Such documents would provide iNova with the name of the Sponsor of any Generic Product that was a bioequivalent of Aldara. In the 2009 calendar year, approximately 23,000 Benefits Scheme prescriptions for imiquimod were dispensed, at a cost to the Commonwealth of some $3.3 million. A 16% reduction in the price of imiquimod would result in savings to the Commonwealth of approximately $400,000 per year. At present there are no bioequivalents of imiquimod registered. 33 Dr Lopert gave evidence to the Tribunal that, apart from providing an opportunity to delay the listing of a Generic Product, knowledge of the existence of an application for listing has commercial value to other potential competitors, who would pay to obtain such information. Dr Lopert said that the entry into the market of a Generic Product could be delayed by the commencement of patent or copyright infringement proceedings. She said that the mere disclosure of the existence of an application for listing, without providing access to documents associated with the application, could lead to identification of the applicant because the Australian market is relatively small. Dr Lopert also gave evidence of other strategies that could be used to delay the entry of Generic Products into the market, such as seeking injunctive relief against regulators, changing the Originator Product to make the demonstration of bioequivalence more difficult, entering into arrangements with suppliers of Generic Products and offering inducements to delay entry into the market. 34 Mr Christiaan van Niekerk of iNova gave evidence to the Tribunal to the effect that iNova would only use information contained in documents obtained under the FOI Act for business strategy purposes. He said that he was unaware how iNova could delay any application for listing by the TGA. Mr van Niekerk said that iNova would not withdraw an Originator Product from the market if it discovered that an application for listing of a Generic Product on the Register had been made. 35 The Tribunal considered that the application of s 25 in relation to imiquimod required two questions to be answered. The first question was whether the putative documents would be exempt under s 37(1)(a). The second question was whether the disclosure of the existence or non-existence of documents falling within the scope of iNova's request, if included in a response, would cause the response to be exempt by virtue of s 37(1)(a). 36 The Tribunal accepted that the words "could reasonably be expected to" in s 37(1) require a judgment that must be reasonably based, as distinct from something that is irrational, absurd or ridiculous. It also accepted that the words "proper administration", in the context of a law of the Commonwealth or of a State in s 37(1), must be given the meaning of proper management of the application of the law. The Tribunal found that, if an application for registration of a Generic Product had been lodged with the TGA, disclosure of that document would provide iNova with details of the Sponsor of the Generic Product and other information. The Tribunal accepted that, in the present instance, it could be argued that such a disclosure could reasonably be expected to prejudice the proper administration of the Health Act, if iNova were to take action to delay listing of the Generic Product on the Benefits Schedule. Accordingly, the Tribunal concluded the first question would be answered positively. 37 However, the Tribunal considered that, even if the putative documents are exempt under s 37(1)(a), the second question must be answered in the negative. The Tribunal observed that s 25(1) only goes to the existence or the non-existence of documents falling within the scope of the request and it does not go to a description of the documents, the author or the contents of the documents. The Tribunal was not satisfied that, in this instance, a response by the Department disclosing the existence or non-existence of documents falling within the scope of iNova's imiquimod request would, itself, be exempt under s 37(1)(a). 38 The Tribunal considered that, in order to establish that delay consequent upon action taken by iNova would flow through to the inclusion of a Generic Product on the Benefits Schedule, so as to have an adverse effect on the Department's ability to obtain value for Australian taxpayers' money, the following five steps would need to be established: that disclosure of the existence of an application for listing on the Register of a Generic Product would lead to iNova being able to identify the Sponsor of the Generic Product; that iNova would take consequent action on discovering the identity of the Sponsor of the Generic Product; that such action by iNova would delay the listing on the Register of the Generic Product; that a delay in listing on the Register would result in a delay in inclusion on the Benefits Schedule; and that a delay in inclusion on the Benefits Schedule would delay a reduction in the subsidy provided by the Commonwealth for the Originator Product. 39 The Tribunal was not satisfied that iNova would be able to identify the Sponsor of a bioequivalent Generic Product from the mere fact of knowing that an application for listing on the Register had been lodged. The Tribunal considered that Dr Lopert's concern, that by a process of deduction and the application of industry knowledge, the Sponsor of a Generic Product could be identified by iNova with reasonable ease, could not be justified. Further, even if iNova were able to identify the Sponsor of the Generic Product, the Tribunal was not persuaded that iNova could take action to delay listing and thereby prejudice the proper administration of the law. The Tribunal had regard to Mr van Niekerk's evidence that he was not aware of what action iNova could take. 40 The Tribunal also observed that, where a person holds a patent for a product or the copyright in a publication, that person is entitled to bring proceedings to restrain infringement of the patent or copyright. The Tribunal considered that instituting proceedings to protect such a right could not be said to prejudice the proper administration of the law, since such proceedings are themselves brought in pursuit of the application of the law. In addition, the Tribunal found that the Department has a specific time frame for the handling of applications for listing on the Register. Accordingly, the Tribunal was not satisfied that any action taken by iNova would delay the listing on the Register of a Generic Product. 41 The Tribunal found, therefore, that the Secretary had not established the first three of the five steps outlined above. However, the Tribunal accept that a delay in the listing on the Register would result in a delay in inclusion on the Benefits Schedule and that a delay in inclusion on the Benefits Schedule could result in a delay in reducing the subsidy provided by the Commonwealth for the Originator Product. In circumstances where three of the five steps identified above had not been established, the Tribunal concluded that the Secretary had not discharged the onus of establishing that disclosure of the existence of the documents sought by iNova could reasonably be expected to prejudice the proper administration of the Health Act. Accordingly, the Tribunal concluded, the Secretary was required to disclose to iNova whether or not the documents sought in respect of imiquimod exist. 42 The Tribunal made its decision, therefore, that the decisions under review be set aside and that the matters be remitted to the Secretary. That aspect of the Tribunal's decision is unexceptionable, in the light of the conclusions that it reached. However, the Tribunal included in its decision a direction that the Secretary must inform iNova whether the documents sought in its requests exist, although it observed that, if the documents do exist, it was open to the Secretary to claim exemption in the usual way pursuant to the provisions of the FOI Act. The Secretary takes exception to the inclusion of that direction in the Tribunal's decision.

THE SECRETARY'S APPEAL 43 In her notice of appeal, the Secretary formulated seven distinct questions of law, with 11 grounds of appeal. In essence, the Secretary's grounds of complaint are that the Tribunal erred in concluding as follows: 1. That the AAT Act authorises the Tribunal to give a direction to the Secretary requiring the Secretary to provide information to an applicant that is not in documentary form. 2. That ss 25(1) and 26(2) of the FOI Act do not allow an agency to make a decision not to inform an applicant whether or not documents exist unless to do so would be to disclose material that would be exempt under s 33, s 33A or s 37(1). 3. That a notice under s 26 in respect of the decision in relation to imiquimod would not prejudice the enforcement or proper administration of the law in the particular instance under consideration because iNova would not use relevant information in a way that might prejudice the proper administration of the Health Act. 44 If the Secretary is successful on the first question but not on the second and third questions, the appeal should be allowed in part, to the extent that the direction that constituted part of the Tribunal's decision would be excised. The Secretary would then be required to make a fresh decision, which would, in fact, disclose whether documents exist. The Secretary accepts that not a great deal flows from the first question alone. 45 If the Secretary is successful on the second question, the whole of the matter should be remitted to the Tribunal, since the Tribunal would be required to make a decision as to whether disclosure in a notice under s 26 of the existence or non existence of documents would cause the notice under s 26 to be exempt by virtue of s 40(1)(d), s 43(1)(b) or s 45. None of those matters has been considered by the Tribunal. The Tribunal would have to determine whether or not a notice under s 26 that disclosed matters that would render it exempt under those provisions would mean that the Secretary would not be required to disclose whether or not documents existed. 46 If the Secretary is successful on the second question, it would not be strictly necessary to determine the third question. However, if the Secretary is unsuccessful in relation to the third question, it would be appropriate for the Court to determine that question so that the Tribunal would not need to reconsider the application of s 37. On the other hand, if the Secretary is successful in relation to the third question, it would be appropriate to decide the matter so that the Tribunal could reconsider the application of s 37. 47 If the Secretary is unsuccessful in relation to the second question but is successful in relation to the third question, the Tribunal's decision in relation to phentermine would be unaffected. However, the decision in relation to imiquimod would then be remitted to the Tribunal to reconsider the application of s 37. 48 If the Secretary succeeds on both the second question and the third question, the whole of the matter would be remitted to the Tribunal, which would then have to decide whether disclosure of the documents was protected on any of the grounds referred to in ss 37(1), 40(1)(d), 43(1)(b) or 45.

Whether the Tribunal Gave an Impermissible Direction 49 I consider that there is substance in the Secretary's complaint, although the question may simply be a matter of form. The substantive question arises, of course, only if the Tribunal's conclusion on the second question was incorrect. 50 Section 43 of the AAT Act gives the Tribunal all the powers and discretions conferred on the decision maker whose decision is being reviewed. However, the FOI Act does no more than confer a legally enforceable right to be provided with documents. There is no entitlement to be furnished with information. That is the effect of s 11(1) and s 18(1). A decision maker in respect of a question arising under the FOI Act would not be required to provide information, but would have a duty to provide access to documents. I consider, therefore, that a direction to the Secretary to provide information, rather than provision of access to a document or documents in accordance with the FOI Act, is beyond the powers of the Tribunal. On the other hand, it would have been open to the Tribunal to direct the Secretary to respond to iNova's requests in a manner that complies with the FOI Act, as properly construed and as explained by the Tribunal. 51 iNova contends that the Tribunal has a broad discretion under s 43(1)(c)(ii) of the AAT Act to give a direction, which is not narrower than the Tribunal's power to substitute its own decision under s 43(1)(c)(i). Therefore, it says, the Tribunal may give a direction as to the proper manner in which a power is to be re-exercised, including, it says, a direction as to the kind of information to be included in a notice under s 26 of the FOI Act. 52 However, that is not what the Tribunal purported to do. It would have been beyond the power of the decision maker, otherwise than, perhaps, in the exercise of a purely executive discretion, to provide information as to whether documents exist. That is not a discretion that the Tribunal can direct a decision maker to exercise. The Tribunal may only direct the decision maker to exercise the power conferred by, or to discharge the duty imposed by, the FOI Act. The FOI Act confers no power and imposes no duty to furnish information, except under s 25 or s 26.

Whether Nondisclosure is Permissible in relation to s 43 or s 45 Exemption 53 Section 25 is concerned with the way in which an agency deals with requests for access. Section 25(1) is not expressed as an exception. Rather, it provides that nothing in the FOI Act is to be taken to require an agency to give information as to the existence or non-existence of a document where information as to the existence or non-existence, if included in a document, would cause such a document to be an exempt document by virtue of ss 33, 33A or 37(1). Further, s 25(2), in its terms, is permissive. That is to say, where a request relates to a document of a kind referred to in s 25(1), the agency may give notice in writing that the agency neither confirms nor denies the existence of such a document but that, if there were such a document, it would be exempt under ss 33, 33A or 37(1). 54 Section 26, on the other hand, is concerned with the reasons for, and other particulars of, decisions about access. The decision maker must give an applicant notice in writing of the decision stating certain matters. However, under s 26(2), such a notice is not required to contain any matter that, if included in a document would have the consequence that that document would be an exempt document. In its terms, s 26(2) is not limited to exemption by virtue of ss 33, 33A or 37(1). 55 Section 24A authorises an agency to refuse a request for access to a document, and s 26(1) would be triggered by such a refusal. The notice given under s 26(1) would be required to say either that the relevant document is in the agency's possession but cannot be found or that it does not exist. However, the qualification in s 26(2) would also apply. 56 Section 25(1) must be treated as a qualification of the right created by s 11, for a person to obtain access to a document in accordance with the FOI Act, and of the obligation imposed by s 18 upon an agency, to give a person access to a document in accordance with the FOI Act. The qualification in s 25(1) and the authority conferred by s 25(2) are both limited by reference to ss 33, 33A and 37(1). 57 On the other hand, the right created by s 11, and the corresponding obligation imposed by s 18, do not extend to an exempt document. The obligation imposed by s 26 to give notice in writing of a decision to refuse access, stating the matters referred to in s 26(1), refers to a refusal to grant access to a document in accordance with a request. Clearly enough, notice in writing of the decision would be required to state that the document that was the subject of the request was an exempt document, if that were the reason for the decision refusing to grant access. There is nothing in the language of s 26(2) that limits the qualification contained in that provision to exemption by virtue of ss 33, 33A or 37(1). There is no reason, in principle, why s 26(2) should be limited in that way. On the contrary, there is every reason, in principle, why it should not be limited. 58 There is nothing in s 26(1) that would, in terms, require a decision maker to include in the notice of the decision a statement that a particular document existed that was exempt. It would be quite anomalous if, notwithstanding s 26(2), the decision maker would be required to disclose, in the notice of the decision, the fact that a document existed or did not exist, notwithstanding that that fact made the notice of the decision itself an exempt document within any of the provisions of Part IV of the FOI Act. 59 While there may be some overlap between the operation of s 25 and s 26(2), the two provisions are directed at different questions. Section 25(1) refers to a requirement for an agency to give information in limited circumstances. Section 26(2), on the other hand, is concerned with the giving of notice of a decision and the matters that are to be stated in such a notice. 60 Section 25 of the FOI Act has work to do, notwithstanding that other provisions in the FOI Act authorise a similar mechanism for protecting certain kinds of information. Section 25 authorises a response that neither confirms nor denies the existence of documents, absent any search for documents of the kind requested. A similar response under s 26(2) is authorised, after a search has been undertaken. That response, however, is permitted only where the inclusion of information about documents would make the notice required under s 26(1) itself an exempt document. They are quite different tests and procedures. The fact that the outcome may be similar in form does not render s 25 otiose. 61 Section 26(2) authorises a notice under s 26 to be modified to ensure that it does not take a form that would make the notice itself an exempt document. One way of doing so would be to provide a response that neither confirmed nor denied the existence of a document. However, that method would not be effective in protecting the relevant kinds of information if the agency in question were bound to make clear that there were no documents that fall within a request, if that be the case. An informed person would know that a response neither confirming nor denying the existence of a document necessarily implied that there were such documents because, on the view contended for, the agency would be bound to state that there were no documents. 62 Hence, a person making a request under the FOI Act, as iNova has, could make periodic requests for the same information in order to see whether the form of the response changed over time. According to the frequency with which requests were made, that person could determine when a document first existed. In the present case, iNova would be able to determine when an application had been made and, accordingly, make a relatively accurate determination of when a relevant Generic Product might come onto the market, potentially resulting in not only a loss of market share but a reduction in the price of its products under the Benefits Scheme. 63 Section 26(2) makes it clear that a non-informative response is authorised in appropriate cases where documents exist. There is nothing in the FOI Act that precludes the making of a response in similar terms, when the documents do not exist. Section 24A(b)(ii) does not prescribe anything about the form of a refusal when a document does not exist. Section 24A(b)(ii) was inserted to deal with a situation where documents expected to exist cannot be found or do not exist anymore. In those circumstances, it is clear enough that that provision was not intended to cover every possible response exhaustively. 64 The construction contended for by the Secretary would not detract from the objects of the FOI Act. Rather, it would promote the protection of information that the Parliament has specifically identified as meriting protection. The construction contended for by iNova, on the other hand, could render ss 40, 43 and 45 ineffective in certain circumstances. 65 I consider that it was open to the Secretary, or her delegate, in giving a notice under s 26(1), to decline to state whether a document existed if to do so would cause the notice of the decision to be an exempt document by reason of the operation of any of the provisions in Part IV of the FOI Act. Accordingly, the Tribunal erred in concluding that the Secretary could not make a decision declining to say whether or not documents of the categories requested by iNova exist.

Whether Enforcement or Proper Administration of Law Prejudiced 66 In light of the conclusion reached above, it is not strictly necessary to deal with the third question. However, it is desirable to make some observations in relation to the Tribunal's determination. 67 The Secretary complains that the Tribunal dealt with the first two steps that it identified as the appropriate process, by reference to findings that it made concerning iNova specifically. The question to be addressed is not whether iNova would be able to identify a putative Sponsor. The exemption under s 37(1)(a) is that disclosure would, or could reasonably be expected to, prejudice the enforcement or proper administration of the law. That is an objective test and does not depend upon the capacity or identity of a particular applicant. The correct question was not whether iNova could or would be able to identify but whether any person would or could be able to do so. To that extent, the Tribunal misdirected itself. 68 The second step considered by the Tribunal was whether iNova would take consequent action on discovering the identity of the Sponsor. The Tribunal in part relied upon evidence from iNova that it would not have taken action because it was not aware of the action that could be taken to cause delay. The analysis of the Tribunal in relation to the second step is flawed in the same way as its analysis of the first step. That is to say, the question is not whether iNova would have taken a particular step. The question is whether, considered objectively, disclosure would or could reasonably be expected to prejudice the enforcement or proper administration of the law. The Tribunal did not consider that question objectively and, to that extent, the Tribunal misdirected itself.

CONCLUSION 69 The appeal should be upheld. The decision of the Tribunal should be set aside. The matter should be referred to the Tribunal for reconsideration according to law and in accordance with these reasons. iNova should pay the Secretary's costs. I certify that the preceding sixty-nine (69) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Emmett.