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Rules for the AIVC July 2014

15 August 2019

Establishment

The Australian Influenza Vaccine Committee (AIVC) is established.

Functions

  1. The AIVC's functions are to provide recommendations to the Chief Medical Adviser1 (CMA) of the TGA about:
    1. the suitability, for the Australian market, of the recommendation that has been made by the WHO regarding the selection of influenza viruses for inclusion in the influenza vaccines for the upcoming Southern Hemisphere season; and
    2. appropriate reassortants and reagents for the nominated viruses.
  2. TGA will publish the recommendations and the CMA's response to the recommendations on its website shortly after the recommendations are made.
  3. The AIVC also has the function of providing advice on any other issues relating to influenza vaccines as requested by the CMA.

Membership

  1. The following are ex-officio members of the AIVC:
    1. the Directors of the WHO National Influenza Centres in Australia;
    2. the Director and Deputy Director of the WHO Collaborating Centre for Reference and Research on Influenza;
    3. the Directors of the WHO National Influenza Centres in New Zealand and South Africa; and
    4. three officers of the Department of Health nominated by the CMA.
  2. The following are 'voting' members of the AIVC:
    1. the Directors of the WHO National Influenza Centres in Australia;
    2. up to 6 independent experts in influenza directly appointed by the CMA.
  3. The following are 'non-voting' members of the AIVC:
    1. the Director and Deputy Director of the WHO Collaborating Centre for Reference and Research on Influenza;
    2. the Directors of the WHO National Influenza Centres in New Zealand and South Africa;
    3. the three officers of the Department of Health.
  4. Each member must have expertise in a least 1 of the following fields:
    1. influenza disease epidemiology; or
    2. influenza vaccine manufacturing process; or
    3. influenza virus genetics; or
    4. influenza virus characterisation; or
    5. regulatory requirements for influenza vaccines; or
    6. clinical trials and vaccine effectiveness studies.

Membership of the AIVC must, to the extent reasonably practicable, represent the widest possible range of the fields mentioned above.

Appointment of members

  1. The CMA shall directly appoint in writing not more than 6 members with expertise in influenza.
  2. The term of appointment is for 3 years but a member may be re-appointed.

Chairperson

The CMA will nominate one Department of Health officer referred to in (4)(d) to be Chairperson.

Resignation or vacancy

  1. A member of the AIVC can resign by giving written notice to the CMA of the TGA.
  2. If the chairperson ceases to be a member of the AIVC the position is taken as vacant.

Termination of appointment

  1. The CMA of the TGA may terminate a member's appointment on any of the following grounds:
    1. physical or mental incapacity;
    2. misbehaviour;
    3. incompetence;
    4. bankruptcy;
    5. failing to comply with the disclosure of interest requirements.
  2. The CMA of the TGA must terminate a member's appointment if the member is convicted of an offence punishable by imprisonment for at least 1 year.

Non-voting members of the AIVC

  1. Non-voting members can attend all phases of the meeting and have the right to participate in all discussions of the AIVC.

Observers to the AIVC

  1. The following observers may be invited [by the Chairperson] to attend the 'open' phases of the meeting:
    1. relevant staff members from the TGA who are not members
    2. representatives from National Influenza Centres outside Australia
    3. relevant organisations/stakeholders.
  2. Persons invited as observers are entitled, until the invitation is revoked:
    1. to be given the agenda of the AIVC meeting; and
    2. by notice in writing to the Chairperson prior to a meeting, suggest agenda items to be considered by the AIVC at that meeting.
  3. A person invited as an observer is not entitled to vote.

AIVC procedures

  1. In performing its functions, the AIVC:
    1. must act in accordance with this document;
    2. must act with as little formality and as quickly as this document and a proper consideration of the issues before the AIVC allow; in this respect voting is non-obligatory and is at the discretion of the Chair. The AIVC usually reaches a consensus without the need for a vote.
    3. is not bound by the rules of evidence;
    4. may obtain information about an issue in any way it considers appropriate;
    5. may receive information or submissions orally or in writing; and
    6. must comply with and directions given, in writing, to the AIVC by the CMA of the TGA about the AIVC's performance of its function (other than a direction about advice given or proposed to be given by the AIVC).

Meetings

  1. The meeting strictly adheres to an agenda starting with an 'open meeting', followed by a 'closed meeting' in which the AIVC recommendation is made in the absence of invited observers, and concludes with an open forum where the AIVC recommendation is announced to observers via the Chair.
  2. Taking into account the advice of the AIVC, the CMA's recommendation on strain selection is officially announced shortly after the meeting via publication of the TGA website.
  3. The chairperson of the AIVC may give written notice to the AIVC, directing the AIVC, or to some members of the AIVC, to hold meetings at the times and places, and to deal with the matters in the manner, stated in the notice.
  4. The procedure of a meeting must be determined by the AIVC in accordance with this document.

Presiding member

The chairperson must preside at an AIVC meeting or recommend another Departmental officer to preside at the meeting.

Quorum

A quorum exists at a meeting when at least half of the voting members are present.

Voting

  1. A recommendation, regarding advice on strain selection to be provided to the CMA, is made at an AIVC meeting usually by consensus, without the need to vote.
  2. If the strain recommendation is not reached by a consensus, only voting members are entitled to vote.

Miscellaneous

Travel entitlements

Economy travel and accommodation expenses directly associated with attending AIVC will be met by the TGA.

Disclosure of Interests/Deed of Confidentiality

All members will be required to sign a Deed of undertaking in relation to confidential information and conflict of interest at the time they are appointed, an Annual declaration of interest and a Meeting disclosure of interest declaration before each meeting they attend. Disclosures of interests by members will be dealt with in accordance with subregulations 42(4) to (6) (inclusive) of the Therapeutic Goods Regulations 1990 as if the AIVC is a statutory committee to which that Regulation applies.

Advice of AIVC

Any advice given by AIVC to the CMA of the TGA may be given to another expert Advisory Committee for the advice of that committee. In performing its functions, the AIVC may seek advice from other persons.

Records and reports

The Secretary of AIVC must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the CMA of the TGA.

Reference

  1. In these Rules, a reference to the Chief Medical Adviser includes a person acting or from time to time performing the duties of that position.