Explanation of Redacted Information (s47) from Notice: 

Paragraph 47E(d): Documents that would have a substantial adverse effect on the proper and efficient conduct of the operations of an agency20. A document is conditionally exempt under paragraph 47E(d) of the FOI Act if its disclosure would, or could reasonably be expected to, have a substantial adverse effect on the proper and efficient conduct of the operations of an agency.21. Document 15 contains information that describes the Regulatory Compliance Branch’s (RCB) assessment criteria for establishing how reports of non-compliance are prioritised. The RCB is responsible for regulatory compliance activities relating to the offence provisions of the Therapeutic Goods Act 1989 (the TG Act), including intelligence, compliance and enforcement action. This includes unlawful advertising, import, export, manufacturing, and supply of therapeutic goods.22. Further, the document evidences the method by which the TGA prioritises and assesses reports of non-compliance (and not to the goods themselves), and the assessment does not specifically cover “therapeutic goods that are listed under section 26A” (but that also relate to the compliance of goods that are not on the Australian Register of Therapeutic Goods).23. I consider that the effectiveness of the procedures/methods used in the prioritisation of non-compliance activities could reasonably be expected to have a substantial adverse effect on the proper and efficient conduct of the operations of the TGA as a result of the disclosure of the information. Specifically, I consider that the document could be used by advertisers and/or suppliers to avoid compliance attention by the TGA. This would have a substantial adverse impact on the TGA’s ability to efficiently identify non-compliance or other such activities that may contravene the provisions of the TG Act and therefore to effectively monitor compliance with the TG Act. 24. Therefore, I am satisfied that information on how the TGA systematically prioritises and assesses compliance is conditionally exempt as its disclosure would, or could reasonably be expected to, prejudice the effectiveness of procedures or methods for the conduct of this regulatory activity, therefore having a substantial adverse effect on the proper and efficient conduct of the operations of TGA. However, I am required under subsection 11A(5) of the FOI Act to give access to the information unless it would, at this time, on balance, be contrary to the public interest.25. I consider that the public interest factors in favour of granting access to the information are as follows:the general public interest in obtaining access to government-held information; andthe objects of the FOI Act which encourage access to information held by government agencies, subject only to certain exemptions.26. I consider that the factors against giving access to the information include the following:the public interest in ensuring the effectiveness and integrity of the audit and regulatory compliance processes of the TGA;the disclosure of the information could reasonably be expected to prejudice the management functions of the TGA, specifically, the TGA’s ability to efficiently prioritise compliance with the provisions of the Act; andthe specific purpose of the information contained within the document is for the assessment of compliance with the expectation that it would be used only for that purpose. It is in the public interest that government uses information for the purposes for which it has been provided.27. On balance, I am of the view that giving access to the information at this time would be contrary to the public interest.28. Please note that under section 11(2) of the FOI Act, your reasons for seeking access are not relevant to my decision to refuse access.29. For the reasons set out above, I am satisfied that some information in Document 15 is conditionally exempt in accordance with subsection 47E(d) of the FOI Act. Accordingly, I have decided to exempt from disclosure parts of the information contained in Document 15 (as identified in the schedule at Attachment A) and the remaining information in the documents may be disclosed to you.
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