Section 16: Committees

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16.1 Membership of the Code of Conduct Committee

1. The following persons shall be eligible to be “full members” of the Code of Conduct Committee (Code Committee):
   1. Chair – Lawyer with competition and consumer law experience.
   2. Three general practitioner representatives nominated by the Australian Medical Association (AMA), the Australian General Practice Network (AGPN), and the Royal Australian College of General Practitioners (RACGP).
   3. A specialist physician nominated by the Royal Australasian College of Physicians (RACP).
   4. A person nominated by the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT).
   5. A Consumer representative nominated by a patient organisation such as the Consumers Health Forum (CHF). Where a complaint is in relation to an activity or material directed at the general public or patients, a second consumer representative will be appointed.
   6. Where a complaint relates to an activity or material directed to the practice of pharmacy, a person nominated by any one of the Pharmacy Guild of Australia (PGA), the Pharmaceutical Society of Australia (PSA) or the Society of Hospital Pharmacists of Australia (SHPA) will be called upon.
   7. Up to a maximum of five representatives from Medicines Australia members or non-member Companies, drawn from the following, as relevant to the complaint.  Where the Complainant Company or Subject Company is a non-member, one of the five representatives will be appointed from a non-member Company.
      • Senior Executive Officers from Medicines Australia Members, as described in the Medicines Australia Constitution, or a non-member Company;
      • Medical or Scientific Directors;
      • Senior Compliance Officers;
      • Marketing Directors.
2. Quorum
   A properly constituted meeting of the Code Committee shall comprise not less than six full members, two of which must be representatives from Medicines Australia Member Companies and one of which must be a representative of ASCEPT. All business of the Code Committee will be conducted at a meeting of a properly constituted Code Committee.
3. Observers
   1. In addition to the full members of the Committee, the following persons may attend a meeting of the Code Committee as observers:
      • One representative of the Therapeutic Goods Administration, as nominated by the Therapeutic Goods Administration;
      • Observers nominated by Medicines Australia who would gain an educational benefit from attendance at a Code Committee meeting and who have no conflict of interest;
      • Medicines Australia Chief Executive Officer or delegate.
   2. Subject to the discretion of the Chair, observers will be entitled to attend and speak at a properly constituted meeting of the Code Committee.
4. Secretariat
   1. The Code Committee will be assisted in administering the business of the Committee by a Code Secretariat comprising:
      • The Code of Conduct Secretary; and/or
      • The Medicines Australia officer responsible for the Ethics and Compliance Program.
   2. Observers and members of the Code Secretariat attending a Code Committee meeting shall have no voting rights.

16.2 Membership of the Appeals Committee

1. The following persons shall be eligible to be “full members” of the Appeals Committee:
   1. Chair – Lawyer with competition and consumer law experience.
   2. A representative from the College and/or Society associated with the therapeutic class of the product subject to appeal, or a specialist with appropriate expertise as relevant to the appeal
   3. A general practitioner representative, nominated by the AMA, RACGP and/or AGPN
   4. A consumer representative, nominated by a patient organisation such as CHF. Where an appeal is in relation to an activity or material directed at the general public or patients, a second consumer representative will be appointed.
   5. A person nominated by the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT).
   6. Up to a maximum of three representatives from Medicines Australia members or non-member Companies, drawn from the following, as relevant to the complaint.  Where the Complainant Company or Subject Company is a non-member, one of these representatives will be appointed from a non-member Company.
      • Senior Executive Officers from Medicines Australia Members, as described in the Medicines Australia Constitution, or a non-member Company;
      • Medical or Scientific Directors;
      • Senior Compliance Officers;
      • Marketing Directors.
   7. Where a complaint relates to an activity or material directed to the practice of pharmacy, a person nominated by any one of the Pharmacy Guild of Australia (PGA), the Pharmaceutical Society of Australia (PSA) or the Society of Hospital Pharmacists of Australia (SHPA) will be called upon.
   8. Medicines Australia may release to the Complainant or the Subject Company the names of the representatives nominated by the College and/or Society associated with the therapeutic class of the product or activity subject to appeal, on the condition that neither party makes contact with these experts prior to or after the Appeals Committee meeting.
2. Quorum
   1. A properly constituted meeting of the Appeals Committee shall comprise not less than three full members, one of which must be a representative of a Medicines Australia Member Company.  All business of the Appeals Committee will be conducted at a meeting of a properly constituted Appeals Committee.
   2. No member of the Appeals Committee can have been a member of the Code Committee that heard the original complaint.
3. Observers
   1. In addition to the full members of the Appeals Committee, at the discretion of the Chair, the Medicines Australia Chief Executive Officer or delegate may attend a meeting of the Appeals Committee as an observer.
   2. Observers nominated by Medicines Australia who would gain an educational benefit from attendance at an Appeals Committee meeting and who have no conflict of interest;
   3. Subject to the discretion of the Chair, observers will be entitled to attend and speak at a properly constituted meeting of the Appeals Committee.
4. Secretariat
   1. The Appeals Committee will be assisted in administering the business of the Committee by a Code Secretariat comprising:
      • The Code of Conduct Secretary; and/or
      • The Medicines Australia officer responsible for the administration of the Code of Conduct
   2. Observers and members of the Code Secretariat attending an Appeals Committee meeting shall have no voting rights.

16.3 Membership of the Monitoring Committee

1. The following persons shall be eligible to be “full members” of the Monitoring Committee:
   1. Chair – a consultant with industry experience in marketing and knowledge of the Code of Conduct
   2. A general practitioner representative, nominated by the AMA, RACGP and/or AGPN
   3. A representative from the College and/or Society associated with the therapeutic class of the material being reviewed
   4. A consumer representative, nominated by a patient organisation such as the CHF. Where the review is in relation to an activity or material directed at the general public or patients, a second consumer representative will be appointed.
   5. Up to a maximum of two representatives from Medicines Australia members, drawn from the following, as relevant to the subject matter under consideration for monitoring:
      • Medicines Australia Member Company Senior Executive Officers, as described in the Medicines Australia Constitution;
      • Medical or Scientific Directors;
      • Senior Compliance Officers;
      • Marketing Directors.
2. Quorum
   A properly constituted meeting of the Monitoring Committee shall comprise no less than three full members, one of which must be a Consumer representative and one of which must be a representative of a Medicines Australia Member Company. All business of the Monitoring Committee will be conducted at a meeting of a properly constituted Monitoring Committee.
3. Observers
   1. In addition to the full members of the Monitoring Committee, the following persons may attend a meeting of the Monitoring Committee as non-voting observers:
      • Up to two employees of Medicines Australia Companies nominated by Medicines Australia who would gain an educational benefit from attendance at a Monitoring Committee meeting and who have no conflict of interest;
      • One observer nominated by Medicines Australia who would gain an educational benefit from attendance at a Monitoring Committee meeting and who has no conflicts of interest;
      • Medicines Australia Chief Executive Officer or delegate.
   2. Subject to the discretion of the Chair, observers will be entitled to attend and speak at a properly constituted meeting of the Monitoring Committee.
4. Secretariat
   1. The Monitoring Committee will be assisted in administering the business of the Committee by a Code Secretariat comprising:
      • The Code of Conduct Secretary; and/or
      • The Medicines Australia officer responsible for the administration of the Code of Conduct.
   2. Observers and members of the Code Secretariat attending a Monitoring Committee meeting shall have no voting rights.

16.4 Procedure of Appointment

Medicines Australia will ensure the fair and equitable selection of members for the Code, Appeals and Monitoring Committees. Membership selection procedures are outlined in the Code Tool Kit.

16.5 Conflict of Interest

1. In advance of each Code, Appeals or Monitoring Committee meeting advice will be sought from all participants in the Committee as to whether there is any conflict of interest associated with the prescription product or activity subject to complaint, the Subject Company, the Complainant, or the material subject to monitoring.
2. In addition to the requirement to disclose a direct or indirect pecuniary interest in a matter about to be considered by a Committee, members and observers should also disclose a conflict of interest if a reasonable third-party would conclude that there was a likelihood that a member of a Committee may be influenced in reaching a decision by factors other than the merits of the case as presented by the Subject Company and Complainant, or in the materials contained within the monitoring review.
3. At the commencement of each Committee meeting, the Chair will again enquire as to whether any Committee member or observer has a conflict of interest associated with the prescription product or activity in relation to the complaint has been lodged, the Complainant or the Subject Company, or the materials subject to monitoring. The Code Committee, Appeals Committee or Monitoring Committee, as relevant, will determine the appropriate action following this disclosure.

16.6 Term of Appointment

1. Members of the Code, Appeals and Monitoring Committees, will be appointed for a period of three years and will be eligible for re-nomination at the completion of their term for a maximum of two (2) terms.
2. Committee Chairs are not subject to a term limitation however their appointment will be reviewed every three years.