Attachment A

Principles

Principle 1: Open access to information held by government and transparency about government decision making

The principle of promoting community access to government information is one of the objects of the Freedom of Information Act 1982 which requires agencies to publish information and provide a right of access to documents. Its purpose is to increase:

• public participation in Government processes, with a view to promoting better informed decision making
• scrutiny, discussion, comment and review of the Government's activities, and
• recognition that information held by the Government is a national resource, and is to be managed for public purposes.²⁷

Principle 2: Regulator's obligation to provide timely information to the public about the quality, safety and effectiveness/performance of therapeutic goods

The TGA has an obligation to the public, health care professionals and consumers to provide timely and accurate information about the quality, safety, and effectiveness/performance of therapeutic goods to health care professionals, consumers, and the general public.

Principle 3: Appropriate protection of trade secrets and intellectual property rights

Therapeutic goods regulators hold information that has a significant commercial value that may have involved a considerable investment in resources and effort to compile. Disclosure of information that would discourage future investment and innovation in the therapeutic goods industry without clear public health benefits could have long term effects on investment in public health.

Principle 4: Timely provision of information to the regulator

The timely, free flow of information to the TGA is essential to effective regulation. The therapeutics industry, health professionals, and the general public, will often freely provide regulators with advanced notice of safety and compliance issues without the need for the TGA to exercise its statutory powers to collect information.

This voluntary sharing of information can greatly assist government regulation, enabling the mitigation of potential risks to public health and safety. It is therefore important to consider whether the release of any information would discourage the timely provision of information in the future.²⁸

Principle 5: Relevance of timing and circumstances to status of information

Depending on its nature, the commercial sensitivity of information can diminish over time. The circumstances in which information was provided, and its commercial sensitivity at that time, is relevant to how it is stored and handled by the TGA. However, its status as commercially confidential information need only be finally determined at the time that consideration is being given to its release.²⁹

The fact that material is in the public domain is a well-recognised basis for rejecting claims that information should not be released under the FOI Act on the basis of potential damage to the company from which it was obtained or that release will reduce the value of the information.³⁰ What is now common knowledge, or in the public domain, will no longer have the necessary quality of 'confidentiality' and it would be difficult to establish that its release could cause any damage. If so, it will no longer satisfy the definition of commercially confidential information.

Principle 6: Consultation

Consultation with the provider of information is a statutory requirement where a request for that information is made under the FOI Act.

Where it is proposed in the public interest to release information to the public in other circumstances and it is not possible to provide that information without disclosing commercially confidential information, every reasonable effort will be made to consult the owner of the information prior to its release.

The adoption of any practice that may involve the release of information (potentially containing commercially confidential information) on a systematic basis will be preceded by consultation with stakeholders. Consultation about any such proposal, seeking views about the exact nature of the information to be released and the timing of any implementation will ensure relevant members of the therapeutic goods industry have an input and also time to prepare.

Principle 7: Excision of personal information

'Personal' information (ie information from which the identity of an individual is apparent or can be ascertained) is sometimes included in what is also considered commercially confidential information.

As a Commonwealth government agency, the TGA is obliged to ensure that personal information is collected, held, used and disclosed in such a way that provides appropriate protection for that individual and is consistent with its obligations as set out in the Privacy Act. Such information will normally be excised from documents released under the FOI Act. It is very unlikely that any release of information by the TGA in the public interest would warrant release of personal information.

Principle 8: Release authorised by or under law

It is important that where the TGA comes to the view that it is necessary to release commercially confidential information to the public such release is authorised by or under the law.³¹ This will most typically be because it is released under the FOI Act or is authorised under section 61 of the Therapeutic Goods Act.

Footnotes

27. See section 3 of the FOI Act.
28. This principle is recognised in an exemption in paragraph 47G(1)(b) of the FOI Act if a 3rd party can demonstrate that release could reasonably be expected to prejudice the future supply of information for the purpose of the administration of a law of the Commonwealth or the administration of matters administered by an agency. The Information Commissioner has confirmed that the test is whether the release will result in a reduction in the quantity and quality of information given to the TGA by sponsors such that the TGA's ability to perform its statutory functions will be prejudiced. See 'Q' and Department of Health and Ageing [2013] AICmr 29 (22 March 2013) at paragraphs 34 to 41 and 'AC' and Department of Health and Ageing [2013] AICmr 50 (24 April 2013) at paragraphs 55 to 62.
29. For instance, the fact that marketing authorisation is being sought for a therapeutic product will lose its commercial sensitivity once approval has been given; otherwise commercially confidential information may become a matter of public knowledge through later external review or publication.
30. See for instance 'Q' and Department of Health and Ageing [2013] AICmr 29 (22 March 2013) 'AC' and Department of Health and Ageing [2013] AICmr 50 (24 April 2013).
31. Thus to the extent that any AusPAR contains commercially confidential information, its release is authorised by a delegate of the Secretary under subsection 61(5C) of the Act relying on the legislative instrument made under subsection 61(5D) of the Act: Therapeutic Goods Information Specification 2009.