Attachment B

Background information on the Freedom of Information Act

Under the FOI Act any person has a statutory right to seek access to documents³² held by the Commonwealth, irrespective of the reasons the person gives for seeking access to or the agency's belief as to those reasons.³³ Agencies holding information, whether generated by the agency or another Commonwealth agency, or provided to that agency by a third party, are required to identify any documents that are within the scope of a request made under the FOI Act and to release them to the person making the request except to the extent any information in the documents is "exempt" under one of the provisions of the FOI Act.³⁴ The motivations of the person seeking access cannot be taken into account in determining whether documents should be released.³⁵

Where documents identified as coming within the scope of the request contain information about the business, commercial or financial affairs of an organisation or undertaking and the TGA believes that the organisation or undertaking would wish to argue that it makes the document exempt under particular provisions of the FOI Act, the TGA is obliged to give the organisation or the proprietor of the undertaking the opportunity to make submissions and take them into account when considering giving access to the documents.³⁶

Those exemptions are under:

• section 47(1)(a) (trade secrets)
• section 47(1)(b) (information having a commercial value that would, or could reasonably be expected to be, destroyed or diminished if disclosed)
• section 47G(1)(a) (information, release of which would, or could reasonably be expected to, unreasonably affect that person adversely in respect of his or her lawful business or professional affairs or the organisation or undertaking adversely in respect of its lawful business, commercial or financial affairs and would be contrary to the public interest)
• section 47G(1)(b) (information, release of which could reasonably be expected to prejudice the future supply of information to the Commonwealth or an agency for the purpose or the administration of a Commonwealth law or the administration of matters administered by an agency and would be contrary to the public interest).

The FOI Act also contains an exemption for documents release of which would found an action for breach of confidence³⁷ but agencies are not required to consult third parties about the application of this exemption.³⁸ There is a degree of overlap between the "breach of confidence" exemption and the exemptions referred to above, particularly whether information is in the public domain.³⁹

An agency is not bound by the submissions of a third party in relation to the application of any of those exemptions. However, if the agency is proposing to release any such documents notwithstanding the submissions made, the agency must not do so unless and until the organisation or the proprietor of the undertaking has had the opportunity to seek internal review and/or review by the Australian Information Commissioner (the AIC) and the Administrative Appeals Tribunal (the AAT).

An FOI applicant also has a right to an internal review and/or review by the AIC and the AAT in relation to any decision to exempt documents under any provision of the FOI Act, including sections 45, 47 and 47G.

An agency is required under the FOI Act to publish any documents made available to the FOI applicant in a "disclosure log" on its website.⁴⁰ The agency is not required to publish any information about the business, commercial, financial or professional affairs of any person, or personal information about any person, if it would be "unreasonable" to publish the information.⁴¹ The decision by an agency to publish on its website documents made available to the FOI applicant is not subject to review.⁴² The TGA will not normally publish documents released to the FOI applicant on the TGA website if the relevant third party objects.⁴³

Where a request for documents made under the FOI Act covers information about which a third party is likely to want to argue that any of the relevant commercial exemptions apply, the TGA follows all the statutory requirements in consulting that company. It is only where either:

• the company agrees to the release of the information in the document to the applicant, or
• where as a result of a review (whether internal, Information Commissioner or AAT) in relation to which the appeal period has expired, a decision has been made to release the information in the document on the basis that any potentially relevant exemptions do not apply,

that the TGA would release the relevant documents to the FOI applicant.

Where documents coming within the scope of an FOI request include information or documents provided by a third party⁴⁴ and contain what appears to be commercially confidential information, the TGA will always consult that third party under section 27 of the FOI Act, even if it is not proposing to release the information. This is because the third party will be in the best position to provide information about the criteria that must be satisfied in order to apply the exemptions in sections 47 and 47G such as the commercial value of the information, how many people know about the content, how the business might be adversely affected if the information were released, whether (in the case of section 47G) release would be contrary to the public interest etc.

As required by the FOI Act, if the decision maker proposes to release any information to which the third party has argued an exemption in section 47 or 47G applies, the third party is informed of its rights to internal and external review, and both the FOI applicant and third party are informed that the material will not be released until that process has been completed.

The Australian Information Commissioner has, under subsection 93A(2) of the FOI Act, published comprehensive guidelines to which agencies are required to have regard in making decisions under the Act. Those guidelines contain extensive material on the application of the exemptions in sections 45, 47 and 47G of the FOI Act.⁴⁵ Third parties consulted under section 27 of the FOI Act are encouraged to consider the guidelines in formulating submissions on the application of exemptions under the FOI Act.

The approach of the TGA to the application of the section 47(1)(b) (diminution of commercial value of information) and 47G (unreasonable adverse effect on business, commercial or financial affairs) where it appeared that the information in relation to which the third party objected to release was already in the public domain, was upheld by the Information Commissioner in the cases 'Q' and the Department of Health and Ageing [2013] AICmr 29 (22 March 2013)⁴⁶ and 'AC' and Department of Health and Ageing[2013] AICmr 50 (24 April 2013).

'Neither confirm nor deny'

One exception to this practice of consulting 3rd parties is where it appears that the effect of responding to the FOI request in the usual fashion⁴⁷ could make the response to the applicant an exempt document. In such a case, the TGA will not consult any third party that may have made such an application but will rely on section 26(2) of the FOI Act to neither confirm nor deny the existence of any documents that may come within the scope of the FOI Act. This approach was upheld by the Federal Court in December 2010 in the judgment Secretary, Department of Health and Ageing v iNova Pharmaceuticals (Australia) Pty Limited [2010] FCA 1442.⁴⁸

Whether or not any of the exemptions apply to particular information provided to the TGA by a third party will be influenced, and in some cases, determined by when the FOI application is made. As noted above, if it is made when an application is under consideration by the TGA, then in order to ensure that information about the application can be exempt, it may be necessary for the TGA to neither confirm nor deny whether any documents coming within its scope do or do not exist.

On the other hand, once the existence of an application has become publicly known through the inclusion of a product on the Register or the publication of an AusPAR then the response to a request for information or data contained in the application will be determined by the application of relevant exemptions to the information or data itself after consultation with the applicant.

Where information has been provided to the TGA in the post-market context (for instance where safety issues about a product have arisen), whether the material or knowledge of the safety issues is in the public domain will be relevant to the application of the exemptions. It may be that the TGA itself has published information about potential safety issues concerning the product as part of its obligations to inform the public about the safe use of therapeutic goods.

Review of FOI decisions

Both the person making the FOI request and the 3rd party consulted about release of information that may be commercially confidential have a right under the FOI Act to request internal review of the initial decision (not to release or to release information, respectively) and/or review by the Australian Information Commissioner and then the Administrative Appeals Tribunal.

Under subsection 27(7) of the FOI Act, TGA cannot release information that is the subject of an objection by a 3rd party unless and until the time for the 3rd party to seek a review of the decision to release has run out, or the decision has been confirmed or otherwise still stands.

Footnotes

32. The definition of "document" under the Freedom of Information Act is very wide and includes information stored electronically from which sounds, images or writing are capable of being reproduced.
33. See section 11 of the FOI Act.
34. The information being sought has to be sufficiently identifiable for the TGA to determine whether or not the relevant document is in its possession.
35. Subsection 11(2) of the FOI Act.
36. See section 27 of the FOI Act.
37. See section 45 of the FOI Act.
38. The TGA has a practice of seeking the views of the 3rd party on that issue as part of any consultation as the 3rd party will be in the best position to inform the TGA whether essential elements of the exemption can be made out, for instance, whether or not the information is now in the public domain. The TGA decision maker will consider whether section 45 might apply to information in appropriate cases. Because the FOI Act does not require consultation about the application of section 45, a 3rd party cannot seek internal review on the basis of the TGA's failure to apply that exemption: 'Q' and Department of Health and Ageing [2013] AICmr 29 (22 March 2013).
39. The guidelines made by the Information Commissioner under section 93A of the FOI Act set out the kinds of matters agencies should take into account in determining whether the exemption in section 45 might apply. These can be found at paragraphs 5.135 to 5.153.
40. See section 11C of the FOI Act. Documents released by the TGA under the FOI Act.
41. See subsection 11C(1) of the FOI Act.
42. Even if the decision is made by an agency not to publish documents on its website because it would be "unreasonable" to do so under subsection 11C(1) of the FOI Act, there is nothing in that Act that would prevent the FOI applicant making that information available to the public.
43. See subsection 11C(1) of the FOI Act.
44. Where a company seeks access to its own commercially confidential information it will normally be provided as a matter of course.
45. The guidelines made under section 93A of the FOI Act.
46. The information in this case was in a TGA letter to the third party rather than information provided by the third party to the TGA but the issues of whether the exemptions can apply where it is in the public domain would be equally applicable.
47. Either (where no application has been made), "no, there are no documents" or, where an application has been made and there is commercially confidential information that comes within the scope of the request "yes there are documents but they are exempt under section 47 and/or section 47G".
48. The background to the adoption of this approach was a succession of requests to the TGA by sponsors of registered medicines asking for documents which would disclose whether an application had been made for a generic version of the registered medicine. A response to a request which changed from "no documents" to "yes there are now documents but they are exempt" or "I am required to consult a third party about your application" would clearly convey the existence and timing of any such application. The decision by the TGA to respond to such requests using the "neither confirm nor deny" formulation was upheld by the Federal Court.