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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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F. Obligations under the Deed of undertaking in relation to interests

The obligations in relation to disclosure of interests are supported by the obligations set out in the Deed of undertaking in relation to confidential information and conflict of interest, which members are required to sign before participating in committee business (but after they have completed their Annual declaration of interests).

By signing the Deed a member:

  • promises that as at the date of signature, and to the best of their knowledge and after making diligent inquiry, they do not have any direct or indirect interests which may, given the nature, role and responsibilities of the Committee, constitute or give rise to an actual or potential conflict of interest or the perception of one in relation to the performance of their duties as a member, other than the interests (already) declared to the Commonwealth in the Annual declaration of interests form
  • undertakes to notify the Commonwealth and the Chair of the Committee in writing of any such interests that they become aware of while a member as soon as reasonably practicable (this will normally be through completion of the annual and meeting declarations of interests but may require an ad hoc notification)
  • undertakes to comply with his or her obligations to disclose under subregulation 42(4) to (7) as described above in relation to any conflicts of interest and otherwise take such steps as the committee may reasonably require to resolve or to otherwise deal with the matter.

The Commonwealth can, under the Deed, sue a member for any losses or costs in relation to any liability arising from a breach of the member's obligations under the Deed.

Process for dealing with potential conflicts of interest

1. Relevant documents

The TGA has formal procedures in place to support the committees in assessing and dealing with conflicts of interest. The approach to conflict of interest issues is reviewed regularly to ensure it maintains currency with legal and departmental requirements. The secretariat will provide the following documents at the appropriate times.

  • Declaration of interests in support of an application for membership of a TGA committee form
  • Annual declaration of interests form, for a member of a TGA committee to be completed within a month of appointment and annually thereafter
  • Meeting disclosure of interests form to be completed by members in relation to matters on the agenda at each meeting attended (this document can also be used to declare interests which have recently arisen/that occur on an ad hoc basis).

When completed, these documents will contain sensitive personal, and occasionally commercially confidential data. The information can only be used for the purposes of recording, reviewing and managing conflict of interest issues. Access to such documents is controlled and will only be granted to employees with a genuine need to know, in connection with reviewing conflict of interests and related issues. For more information on the approach that TGA takes on confidential information please see TGA approach to disclosure of commercially confidential information (CCI).

2. Prior to the meeting

Once all agenda items are identified, the secretariat will provide a copy of the proposed agenda to the members. The list of agenda items will be sent together with the meeting declaration form and a request for the member to consider whether there are any items in relation to which the member may need to disclose an interest. The member should contact the Chair and secretariat as soon as possible about any such interest. If the member comes to the view that the interest is of such a nature that he or she should not be present during consideration of the item by the committee the Chair should be informed as soon as possible so the opportunity can be taken, if necessary, to put alternative arrangements in place, for instance, by inviting additional speakers to attend or changing the speakers list. In such a case the agenda item documents may not be provided to the member.

Any member proposing to attend the meeting should complete the meeting declaration form prior to the meeting so that the speakers' lists can be determined before the agenda papers are released.

Any person who is not a member but is invited to attend a particular meeting will also be asked to disclose any relevant interests to the Chair prior to the meeting, by completing a meeting declaration form.

3. Meeting procedures

Each committee meeting will have a standing item on its agenda to consider conflicts of interest. At the commencement of each meeting, or as appropriate, the Chair of the meeting will invite members to declare any previously undeclared actual or potential conflicts of interest in relation to any item on the agenda. Any member with a potential conflict in any agenda item must declare it at this time, whether or not it has been declared to the Chair before the meeting.

If the member has volunteered not to participate in the committee's consideration of the agenda item as a result, the nature of the interest can be identified in general terms. Otherwise, the member will need to disclose sufficient information that will allow the committee to come to a view about whether a potential conflict of interest exists (whether actual or perceived).

The committee must determine for each agenda item in relation to which any member has declared a potential conflict of interest (and who has not volunteered to be absent during consideration of that item), whether, and if so, to what extent, the member may be present during the committee's consideration of that item. The committee will normally consider the issue of whether members who have made a declaration should be present during the relevant item only when that item is reached on the agenda at which time those members should leave the room.

Appropriate arrangements will be put in place to achieve the same outcome for a meeting conducted by teleconference or videoconference.

The Regulations make it clear that no member who has declared an interest in an agenda item can be present during the committee's consideration and determination in relation to that interest. Affected members should therefore facilitate that consideration by leaving the room when the committee comes to consider the matter of their presence during consideration of the agenda item.

Where the member who is disclosing the interest is the Chair, another member chosen by the members present must preside at the meeting for this purpose.

Any person who is not formally a member but who has been invited to participate will also be required to disclose any interests at this time.

4. Consideration by the committee of a disclosure

It is a matter for the person chairing the meeting and remaining members to come to a view about:

  • the process by which they come to a decision about the involvement (if any) of a member who has disclosed an interest in an item on the agenda
  • the extent of the involvement (if any) of the member in consideration of that agenda item.

The committee may find that it does not have sufficient information to come to a view about either of those matters. It may therefore be necessary for the person chairing the meeting to seek additional information from the member about the nature of the interest to allow the committee to come to a view (refer section E above).

5. Keeping of records

A record must be kept of the interest declared and the decision of the committee (including, where the decision is to allow the member to be present, the conditions (if any) under which the member was present and/or the nature of the member's participation in the committee's consideration of the agenda item). That information will be kept on file.

Subregulation 42(5) states that the disclosure of interests by members must be recorded in the minutes of the meeting. The secretariat will:

  • record in the minutes of the meeting a member's specific disclosure of interests for each agenda item
  • keep copies of any declarations of interests on file.

There must be a clear record of whether, having declared an interest, a member was or was not present when the committee considered the relevant agenda item. If they were present but only for limited purposes (for instance, just to answer technical questions or for discussion, but not for the framing of the recommendation), that must also be recorded in the minutes.

If the committee agrees that a member can participate in the relevant agenda item, the record should include an indication of the nature of the interest and the outcome of consideration by the committee of whether the member should be present for consideration of the relevant matter. Consideration should be given to how much detail about the interest has to be recorded, particularly if the interest is personal. The same applies if the committee decides that the member should not be present. This helps ensure consistency of approach by allowing the committee to refer to the outcomes of previous disclosures.

On the other hand, if the member volunteers to absent themselves from consideration of a particular matter, it would not normally be necessary to record in the minutes more than the fact that the person disclosed an interest in that matter and that they volunteered to absent themselves. However, there may be situations where the recording of more information about the nature of the interest would be appropriate.

Under the Regulations, the recommendations of the committee are required to be published. Other committee outcomes may also be published at the discretion of the TGA.

Disclosure of interests or the outcome of such disclosures will not be published by the TGA.

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