Scintilla – a flash, a spark, an iota. Shorthand for creativity and an indicator of inventiveness under Australian law.

Tuesday, May 20, 2014

TGA confirms its approach to disclosure of commercially confidential information

By Alison Beaumer, Senior Associate

The TGA has released the final version of a document outlining its approach to disclosure of commercially confidential information, including information provided by medicine sponsors. This follows the release of a draft version in June 2013 and a period of public and industry consultation.

The TGA will now classify confidential information provided to it according to the Australian Government Classification System. This involves the use of 5 Disseminating Limiting Markers (DLMs), namely: 'For Official Use Only' (where disclosure may cause limited damage to commercial entities or members of the public), 'Sensitive' (where secrecy provisions apply or disclosure is prohibited), 'Sensitive:Legal', 'Sensitive: Cabinet', and 'Sensitive:Personal'. Commercially confidential information provided to the TGA, including by medicine sponsors, is likely to be classified as 'For Official Use Only'. One key change of terminology is that sensitive business or commercial information previously classified as 'Commercial-in-Confidence' will now be classified as 'For Official Use Only'.

There does not appear to be anything radical in the TGA's final approach to disclosure, which provides medicine sponsors with some comfort regarding consultation over and above that contained in the original draft. The basic principle is that the TGA will not release commercially confidential information except in particular circumstances where it can justify the release in the public interest and it is lawful to do so. The owner of the information will almost always be consulted prior to any disclosure, as outlined in the following common scenarios:

FOI requests: The TGA is already obliged to consult the owner of the information regarding any proposed disclosure under the FOI Act and medicine sponsors will be very familiar with the process of making submissions about confidentiality and other exemptions from disclosure in this context.

Ad hoc releases in the interests of public health: All reasonable efforts will be made to consult the owner of the information prior to its release and it is unlikely that consultation would not be undertaken other than in "exceptional public health circumstances". This is a stronger statement than the draft version, which stated that in particular circumstances consultation might be impractical or unwarranted where there is an overriding requirement for timely publication of relevant information.

Regular or systemic releases: Affected stakeholders will be consulted before any decision to commence releasing potentially sensitive information to the public on a regular or systematic basis.

Much will of course depend upon how the TGA applies its approach on a case-by-case basis, which will involve consultation with the owner of the information and the balancing of a number of factors. It remains to be seen whether the TGA will in fact take a narrower approach to what should not be publicly released than it has done in the past. The document stresses that information will not be treated as commercially confidential simply because it has been described in that way by the owner of the information. Even when information is classified as commercially confidential, one of the principles to be considered in assessing whether it should be released is the public interest in open access and transparency about government decision making. This is in keeping with the increasing trend towards transparency of TGA decision making, as exemplified by the publication of AusPARs since late 2009 for both successful and unsuccessful applications for registration.

No comments:

Post a Comment