Medical Device Evaluation Committee (MDEC) - disclosure of interest guidelines

November 2003

Members of MDEC and its subcommittees have been appointed on the basis of their expertise to provide independent medical and scientific advice on the safety, quality and performance of medical devices supplied in Australia, including issues relating to premarket conformity assessment and post market monitoring. Given member' experience and expertise, it is likely that members of MDEC and its subcommittees have, or had, some involvement or association with one or more aspects of medical device research, development, manufacture, testing, evaluation, marketing or use. The following disclosure of interest guidelines are designed to assist MDEC and its subcommittees in consideration of the issue of conflict of interest in their decision-making.

The issue of conflict of interest as it pertains to MDEC and its subcommittees is governed by Regulation 39 of the Therapeutic Goods Regulations - see Appendix 1.

It is the individual responsibility of all members to identify and disclose any direct or indirect conflict of interest relating to an agenda item. It is the responsibility of the MDEC as a committee to deliberate on any conflict of interests declared by members, to determine whether a conflict of interest exists and the member's subsequent preclusion, partial involvement or full involvement in the MDEC discussions.

Annual declaration

All members must advise the Chairman, through the Secretariat, on an annual basis, of:

1. the names of the companies or institutions from which they have a pecuniary interest eg. Shares, board membership, consultancy, paid speaker/adviser, commissioned-paid work, fellowship, research grant, travel grant, conference expenses or other hospitality;
2. the names of specific products and their companies for which they have had some involvement, eg. clinical trial involvement, investigator, expert adviser.

Declaration of conflict of interest at meetings

It is the member's responsibility to declare any potential conflict of interest with an agenda item and conduct themselves in accordance with the following guidelines with regard to any further consideration of that agenda item.

If a member believes that a potential conflict of interest exists with regards to an agenda item, they should declare the potential conflict of interest for deliberation and determination by the Committee. Following a declaration of a potential conflict of interest, a member should not be present for the discussions or deliberation of the Committee with respect to the matter.

If MDEC determines that a member does have a conflict of interest in relation to a considered matter, the member's name and disclosure is recorded in the minutes of the meeting, unless the Committee otherwise determines.

Committee determinations of conflict of interest

1. A member who has at any time been involved with a medical device product under consideration by the Committee and has personally received payment for that involvement, in any manner, including via an intermediary agent, from the medical device industry, should take no part in proceedings as they relate to the product.
2. A member who has current pecuniary interest in the medical device company concerned should take no part in proceedings as they related to that product, except at the Chairman's discretion to answer questions from other members.
3. A member who has a current pecuniary interest relating to a product which is a competitor to the product under consideration should declare their interest in the competitor company and take no part in proceedings, except at the Chairman's discretion to answer questions from other members.
4. A member who has had a particular involvement in the development of a medical device (eg. Sitting on an Advisory Board or a principal investigator involved in the design of clinical trial protocols) which they believe constitutes a potential for conflict of interest, should declare this for determination by the Committee.
5. Involvement in medical device industry-sponsored trials by the provision of patients for inclusion in a multi-centre trial, participation in investigators' meetings, where the member does not have an involvement in the trial design, monitoring or preparation of trial report should be declared by the member. This should not preclude the member from active and full participation in the meeting, unless the member believes that their particular involvement has provided them with a conflict of interest.

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