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TGA advisory committee guidelines

Declarations of interests, managing conflicts of interests and confidentiality obligations, Version 1.9, August 2016

7 September 2016

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H. Other matters

Freedom of Information (FOI)

Under the Freedom of Information Act 1982 (FOI Act) a person has a right to access documents held by the TGA unless the document is exempt. One of the grounds of exemptions is 'personal information', the disclosure of which would be 'unreasonable' and would not be in the public interest. Another ground of exemption is that release of the document may have a substantial adverse effect on the proper and efficient conduct of the operations of an agency.

The fact that the effect of the release of information about a member's personal interests (such as members' declarations of interests) or about the member's contributions to discussion on an agenda item might be that, those with appropriate qualifications and expertise would be less inclined to make themselves available to assist the TGA in the carrying out of its regulatory functions through membership of an advisory committee, would be relevant to the application of these exemptions.

If a document containing personal information about a member of a committee was relevant to an FOI request, that member would be consulted about the release of that information. Under the FOI Act that information could not be released by the TGA unless and until the opportunity to have that matter reviewed by the Office of the Australian Information Commissioner and the Administrative Appeals Tribunal had been provided to the member.

Working documents

Each document (whether in hard copy or in electronic form) created, sent and received in the course of carrying out duties as a member of a committee is potentially a Commonwealth Record and must be kept by the TGA in line with Commonwealth legislation. Commonwealth Records can include: emails, minutes of meetings, presentations and associated notes.

In this context, members should be aware that committee documents on which they have made comments, or documents prepared by members for use in committee meetings, that are in the possession of the TGA will need to be identified if they come within the scope of an FOI request. Whether any exemption may be applicable in relation to those documents will be assessed on a case-by-case basis.

Comcover arrangements

The TGA's insurance policy with the government insurer, Comcover, provides members of the TGA's committees with the same extent of cover for liability and professional indemnity in relation to their work on the committee as a TGA employee for their work. However, that cover does not extend to serious or wilful misconduct.

As with most insurance policies incidents that could potentially be the subject of litigation must be notified to the insurer, and there are time limits for notifying such incidents. It is extremely important that members notify the TGA as soon as they become aware of a potential incident (for example, accidentally losing or mislaying confidential information provided by the TGA). Details of the policy are located on the Department of Finance website.

Invitees at committee meetings and members of subcommittees

On occasions a person who is not a member of a committee will be invited to attend a meeting of a committee. Subcommittees that may, under the Regulations, be established by a committee may also have participants who are not members of the committee itself.

When such a person is invited to a meeting (other than as an observer) they will be sent by the secretariat a modified meeting disclosure of interests form to be completed, signed and returned either at, or before, the meeting.

The same rules apply to invitees as apply to members of the committee. The person should, as soon as they become aware that they have a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered by the committee, disclose that nature of the interest. They will also be directed to a copy of the guidelines on the TGA website so they can see the types of interests they should be considering.

The person, unlike members of the committee, is unlikely to have completed any declarations of interest that are accessible to the Chair and Secretary. Moreover, in most cases the person's invitation to attend a meeting will be prompted by the need for their expertise to be available in relation to a particular matter or item. The issue of possible interests that would need to be disclosed in relation to matters that will be considered at the relevant meeting may need to be discussed with potential invitees in order to assist the Chair in identifying appropriate non-members to attend. The Chair will, however, be relying on the person to be very careful in assessing whether there are any interests to disclose. It is very important that the Chair be notified as soon as possible if there is likely to be an interest to be disclosed so alternative arrangements can be made if necessary.

Whether or not an interest is disclosed to the Chair before the meeting, the person will be required to disclose any interest at the meeting and it will be treated as if the person were a member.

All non-member persons attending a meeting will also be asked to sign a modified Deed that covers the person's obligations in relation to confidential information.

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