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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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D. Declaration of interests

So that any potential conflicts of interest can be more readily managed by the committees, the TGA requires members to declare any interests of the kind that a member may need to disclose under Regulation 42. Members should declare both pecuniary (which may include professional) interests and non-pecuniary interests. Members should take into account the nature of the committee's role, functions and responsibilities when determining whether to declare a particular interest but are advised to err on the side of declaring interests rather than not.

Members declare these interests by means of the following declarations.

  • a declaration of interest in support of application/expression of interest in relation to committee membership
  • a declaration at the time of appointment as a committee member
  • an annual declaration by the member thereafter
  • a meeting disclosure of interests declaration or
  • the notification of any new/additional interests as soon as practicable after they arise or become apparent, which may be before, or at a meeting, or on an ad-hoc basis.

What kinds of interests must be included in these declarations?

There is no legislative definition of the terms 'personal interest' or 'pecuniary interest' in the Therapeutic Goods Act 1989 (the Act) or in the Regulations. Nor are there definitions of 'direct' and 'indirect' interests.

In general, pecuniary interests are monetary or financial interests that have the potential for material gain or profit but can be anything that is capable of being measured in terms of money (including loss). Indirect pecuniary interests may include what might otherwise be described as 'professional interests', such as involvement in sponsored research or provision of support by a company to a student or patient. See the list below for examples.

Examples of direct and indirect pecuniary interests*

  • Shares
  • Consultancies
  • Contracts
  • Commissioned fee-paid work
  • Sponsorships
  • Grants
  • Directorships
  • Board memberships
  • Partnerships, trusts
  • Other investments
  • Ownership of a patent
  • Paid speaker
  • Paid expert adviser
  • Having a financial involvement with products, services or other matters having any connection with therapeutic goods or any type of paid work
  • Paid conference expenses
  • Grants for research or other educational benefits
  • Holding a paid retainer to provide professional advice
  • Hospitality from a company involved in the therapeutic goods industry
  • Participation as a researcher or unpaid expert adviser
  • Involvement in any company or organisation involved in the development, manufacture or marketing and distribution of therapeutic goods, including:
    • membership of an advisory board in relation to the company or organisation
    • accepting sponsorship of an event, or for a professional organisation from such a company or organisation
    • provision by such a company or organisation of ad hoc support for a patient or student
    • participation in a clinical trial
    • involvement as a researcher, expert adviser or investigator.

* This is not an exhaustive list. If in doubt about whether an interest should be declared, members should declare the interest.

1. Interests of members of the immediate family

Interests of members of the family of a person may well be an indirect pecuniary interest if it affects or could affect the person financially (for instance, the fact that the spouse of a person is an employee of a pharmaceutical company might be regarded as an indirect pecuniary interest of the person).

In the annual declaration form members are asked to list relevant interests of members of their 'immediate family'. Just who is a member of the 'immediate family' for this purpose will depend on the member's particular situation. A spouse/partner will normally be included and children may be, depending on the circumstances (dependent children will for instance, normally be included).

Consideration should be given to whether the nature of the relationship with the particular family member is such that their interests could be perceived by a reasonable observer as impacting on the capacity of the member to be independent, objective and impartial in relation to their duties as a committee member.

2. Personal interests

Personal interests may extend to the holding of strong personal, philosophical or religious beliefs or convictions, or a person's personal circumstances or family/other relationships (for instance where a close friend has extensive involvement in the pharmaceutical medicines industry or has substantial financial interest in particular therapeutic goods).

It may be that the member, a member of their family, or a close friend has a specific or uncommon condition, the treatment of which could be affected by a therapeutic good or other matter that could be considered by the committee, or the member may have some other personal interest or ethical position in relation to a particular treatment.

Such interests will only be relevant if they are of such a nature that they could give rise to an obligation on the member to disclose the interest under subregulation 42(4) to (7) in relation to a matter to be considered by the committee. That will depend on the nature of the committee's role, functions and responsibilities and the nature of the matters that are likely to be considered by the committee from time to time.

Whether or not a member declares such an interest in an annual declaration form, it will have to be disclosed if it is 'material' to a matter to be considered by the committee. The fact that someone is being treated for common conditions such as hypertension or high cholesterol would not normally be considered as 'material'. If the nature of an interest that involves a medical condition or personal beliefs is particularly sensitive, the member may volunteer not to participate in the committee's consideration of the matter without needing to provide details.

Membership of sporting clubs or societies would not normally be required to be included in a declaration, though membership of a professional organisation should be included.

Process for members to declare interests

Members are responsible for informing the TGA of any interest that could give rise to an obligation to disclose in relation to a matter before the committee.

1. Declaration at time of application/expression of interest

Members of TGA's committees are appointed by the Minister for Health. For the purposes of considering whether a person is suitable for appointment to a committee, the TGA requests information about the range and nature of material interests a potential appointee has currently, material interests the potential appointee has had over the previous five years, or material interests that are, or may be, forthcoming. An assessment can then be made whether those interests would affect the person's ability to perform effectively his or her role on the committee if the person were to be appointed.

The TGA therefore requires a declaration of interests be provided with an application, or expression of interest, in relation to committee membership. The potential appointee is asked not only to provide information about existing pecuniary and non-pecuniary interests but also about likely future interests.

The TGA has to exercise caution with recommending appointees who already have interests and are likely to acquire or have interests in the future that would result in the person being unable to participate in matters likely to be considered by the relevant committee that are related to their field of expertise, so as to minimise the possibility of losing access to that expertise.

The TGA cannot prevent a member of one of its expert advisory committees from acquiring further interests during their membership. However there is an expectation that a person, who once appointed, acquires an interest of the kind that, if the person had the interest at the time of application, a recommendation would not have been made for their appointment, the member will consider resignation from the committee on the basis that the interest is not compatible with continuing membership. A member proposing to for instance, acquire shares in a company manufacturing or sponsoring therapeutic goods or to accept advisory board membership for that company, or take on a consultancy or other paid work with, or sponsorship from, such a company should consider their position and discuss it with the Chair of the committee, or the Deputy Secretary of the TGA.

Apart from being required to provide information about relevant interests, the potential appointee is asked to declare that they understand that if they are appointed they will be required to comply with the obligations in subregulation 42(4) to disclose an interest in matters coming before the committee and that in such cases the committee will have a discretion under subregulation 42(5) to determine the extent of their involvement in consideration of that matter.

2. Declaration on appointment, followed by annual declarations

Within a month of being appointed (and in any event before the first meeting they attend), members (including the chairs) must complete a written declaration of their pecuniary, non-pecuniary and other personal interests. This should include those that, taking into account the nature of the committee's role, functions and responsibilities, may give rise to an obligation on the member to disclose an interest in a matter under subregulation 42(4).

Thereafter, members must complete a declaration of interest at least once a year. This declaration replaces any previous annual or meeting declaration. It should reflect the full range of relevant interests of the member as at the date the declaration is signed.

Common sense should apply in determining the level of detail required on a member's declaration of interest in relation to their business activities. Significant business activity should be listed, but an exhaustive list of minor business contacts is not required.

In relation to the declaration of the interests of members of the immediate family (see discussion above), a member can only declare interests of which they are aware.

As noted above, while members are not expected to declare the detailed nature of personal interests, such as medical conditions or religious beliefs on their annual form, members should be aware that they are required to declare an interest of this nature should an agenda item arise that would require it to be disclosed under Regulation 42(4) (see discussion above).

The relevant secretariat is responsible for the secure storage of the documentation referred to above. It should be noted that, depending on the nature of the information provided, a member's declaration of interest may be provided to the TGA Executive and/or Minister for further assessment.

3. Declarations of additional interests before or at meetings

To cover interests that arise between annual declarations, there are additional declaration of interest processes relating to each meeting (see below). Members should include any interests of the kind that should be included in an annual declaration that have been acquired or that have come into existence since the most recent annual or meeting declaration.

4. Ad-hoc declarations

Under the Deed of undertaking in relation to confidential information and conflict of interest (see below), members are required to undertake to notify the Commonwealth and the Chair of any additional interests in writing 'as soon as is reasonably practicable'. If a member becomes aware of such an interest and is not likely to be attending a meeting (and therefore completing a meeting declaration) in the near future, the member should inform the committee secretary directly in writing.

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