Commonwealth Numbered Regulations

THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1997 No. 400 - REG 17

17.1 After regulation 42, insert in Part 6:

"Division 2-Therapeutic Goods Advertising Code Council Therapeutic Goods
Advertising Code Council

"42A. A committee, to be known as the Therapeutic Goods Advertising  Code
Council, is established. Functions of the Council

"42B. (1) The Council's functions are:

   (a)  to consider requirements for the advertising of therapeutic goods and
        changes to the Therapeutic Goods Advertising Code, to accept
        submissions for this purpose and to advise the Minister accordingly;
        and

   (b)  to make recommendations to the Minister for achieving greater
        uniformity in approval processes and standards for advertising
        therapeutic goods in print and broadcast media; and

   (c)  to make recommendations to the Minister about requests for review of a
        decision of the Secretary under regulation 5G; and

   (d)  to consider matters raised at Council meetings by observers to the
        Council and advise the Minister accordingly; and

   (e)  to advise the Minister on any matter referred to the Council by the
        Minister or Secretary; and

   (f)  any other function conferred on the Council by these Regulations.

"(2) The Council may, with the approval of the Minister, appoint sub-
committees of its members to inquire into, and report on, any matter that is
within the functions of the Council. Membership of the Council

"42C. The Council is to have 12 members as follows:

   (a)  4 manufacturer/supplier members, comprising 1 person nominated by each
        of the following bodies:

        (i)    the NFAA;

        (ii)   the PMAA;

        (iii)  the Australian Direct Marketing Association;

        (iv)   the Direct Sellers Association of Australia;

   (b)  2 advertising industry members, comprising 1 person nominated by each
        of the following bodies:

        (i)    the Australian Association of National Advertisers;

        (ii)   the Advertising Federation of Australia;

   (c)  2 consumer members, comprising 1 person nominated by each of the
        following bodies:

        (i)    the Australian Consumers Association;

        (ii)   the Consumers' Health Forum;

   (d)  3 health care professional members comprising:

        (i)    1 person nominated by the Australian Traditional Medicines
               Society; and

        (ii)   1 person nominated jointly by the Pharmacy Guild of Australia
               and the Pharmaceutical Society of Australia; and

        (iii)  1 person nominated by the Royal Australian College of General
               Practitioners;

   (e)  1 government member nominated by the Therapeutic Goods Administration.
        Term of office of Council members

"42D. (1) A member of the Council holds office for a term of 2 years from the
date of the member's nomination.

"(2) A person cannot hold office for more than 3 consecutive terms.

"(3) This regulation applies subject to:

   (a)  regulation 42F (Resignation); and

   (b)  regulation 42G (Cessation of membership). Chairperson of the Council

"42E. (1) At the first meeting of the Council, and afterwards as the occasion
arises, the Council must appoint a member of the Council to be the chairperson
of the Council.

"(2) The chairperson must be a member nominated by the NFAA or PMAA.

"(3) Unless the chairperson earlier resigns the office, or ceases to be a
member of the Council, the chairperson holds office for 1 year from the date
of his or her appointment. Resignation

"42F. (1) A member of the Council nominated by a body may resign as a member
by notice in writing to the Council.

(2) The chairperson of the Council may resign the office of chairperson by
notice in writing to the Council. Cessation of membership

"42G. A person ceases to be a member of the Council if:

   (a)  the person resigns as a member; or

   (b)  the body who nominated the member nominates another person to be a
        member in place of the person first mentioned; or

   (c)  the member is absent for 2 consecutive meetings of the Council without
        leave of the chairperson; or

   (d)  the Council resolves to remove the member. Alternate members

"42H. (1) A body mentioned in regulation 42C may appoint a person who is not a
member of the Council to be the alternate of a member nominated to the Council
by that body.

"(2) If a member is absent from a meeting of the Council, the member's
alternate (if any) is entitled to attend the meeting and, when so attending,
is taken to be a member of the Council.

"(3) If a person ceases to hold office as a member:

   (a)  the person who was the person's alternate immediately before the
        person ceased to hold office is entitled to attend meetings of the
        Council while the office is vacant and, when so attending, is taken to
        be a member of the Council; and

   (b)  the person is taken to be the alternate of a person nominated to the
        vacant office until a new alternate is appointed.

"(4) A person appointed by a body as an alternate may resign the appointment
by notice in writing to the body. Observers to Council

"42J. (1) Each of the bodies mentioned in subregulation (2) may nominate a
person to attend meetings of the Council as an observer.

"(2) For subregulation (1), the bodies are:

   (a)  the Australian Pharmaceutical Manufacturer's Association; and

   (b)  the Cosmetics, Toiletries and Fragrances Association of Australia; and

   (c)  the Medical Industries Association of Australia.

"(3) A person nominated as an observer is entitled, until the nomination is
revoked:

   (a)  to be given the agenda and minutes of Council meetings, as if the
        person were a member of the Council; and

   (b)  by notice in writing to the chairperson suggest agenda items to be
        considered by the Council; and

   (c)  if the person has given notice to the chairperson that the person
        intends to attend a meeting of the Council-to attend the meeting and
        vote on any question in accordance with regulation 42L. Quorum

"42K. At a meeting of the Council, a quorum consists of the chairperson and 5
other members of the Council including:

   (a)  a member nominated by the NFAA or PMAA; and

   (b)  an advertising industry member; and

   (c)  a consumer member; and

   (d)  a health care professional member; and

   (e)  the government member mentioned in paragraph 42C (e). Meetings

"42L. (1) Meetings of the Council are to be held at the times and places that
the chairperson directs.

"(2) The chairperson is to preside at meetings of the Council at which he or
she is present.

"(3) If the chairperson is absent from a meeting, a member nominated by the
chairperson or, if no member is nominated, a member chosen by the members of
the Council present at the meeting, is to preside.

"(4) A question (other than a question mentioned in subregulation (6)) arising
at a meeting of the Council is to be decided by a majority of the votes of the
members and observers present and voting, with the person presiding at the
meeting having a casting vote.

"(5) An observer is entitled to vote at a meeting on any question affecting
the interests of the body nominating the observer.

"(6) The chairperson is to decide whether a question affects the interests of
the body nominating an observer. Effect of vacancy

"42M. The exercise of a power or the performance of a function of the Council
is not affected by any vacancy in the membership of the Council. Disclosure of
interest

"42N. (1) A member of the Council (including a person taken to be a member
under regulation 42H) who has a direct or indirect pecuniary interest in a
matter being considered or about to be considered at a meeting of the Council
must, as soon as possible after the relevant facts have come to the member's
knowledge, disclose the nature of the interest at a meeting of the Council.

"(2) The disclosure is to be recorded in the minutes of the meeting and the
member must not, unless the Council otherwise determines:

   (a)  be present during any deliberation of the Council with respect to the
        matter; or

   (b)  take part in any decision of the Council with respect to that matter.

"(3) For the purpose of the making of a determination in relation to the
member who has made the disclosure, any member who has a direct or indirect
pecuniary interest in the matter to which the disclosure relates must not:

   (a)  be present during any deliberation of the Council for the purpose of
        making the determination; or

   (b)  take part in the making of the determination by the Council.

"(4) Subregulations (1), (2) and (3) apply to an observer to the Council who
is intending to take part in any decision of the Council on a matter as they
apply to a member. Procedure generally

"42P. So far as these Regulations do not provide for the procedure of the
Council, the Council may determine its own procedure. Annual report

"42Q. Within 3 months after the end of a financial year, the Council must give
the Minister a written report on the operation of the Council for that
financial year.

"Division 3-Complaints Resolution Panel Complaints Resolution Panel

"42R. A committee, to be known as the Complaints Resolution Panel, is
established. Function of the Panel

"42S. The function of the Panel is:

   (a)  to receive and consider complaints about advertisements under Part 2,
        Division 5; and

   (b)  to take action and to make recommendations to the Secretary on the
        complaints in accordance with that Division. Membership of the Panel

"42T. (1) The panel is to have 8 members, as follows:

   (a)  a chairperson nominated by the Therapeutic Goods Advertising Code
        Council;

   (b)  2 members, comprising 1 person nominated by each of the following
        bodies:

        (i)    the NFAA;

        (ii)   the PMAA;

   (c)  2 consumer members, comprising 1 person nominated by each of the
        following bodies:

        (i)    the Australian Consumers Association;

        (ii)   the Consumers' Health Forum;

   (d)  3 health care professional members comprising:

        (i)    1 person nominated by the Australian Traditional Medicines
               Society; and

        (ii)   1 person nominated jointly by the Pharmacy Guild of Australia
               and the Pharmaceutical Society of Australia; and

        (iii)  1 person nominated by the Royal Australian College of General
               Practitioners.

"(2) A person cannot be nominated as a member of the Panel if the nomination
would result in there being more than 4 members of the Panel who are members
of the Therapeutic Goods Advertising Code Council.

"(3) A person cannot be nominated as a member of the Panel if the person is
engaged in the process of approving advertisements for the NFAA or PMAA, under
a delegation to the NFAA or PMAA under regulation 5Q. Term of office of Panel
members

"42U. (1) A member of the Panel holds office for a term of 2 years from the
date of the member's nomination.

"(2) A person cannot hold office for more than 3 consecutive terms.

"(3) This regulation applies subject to regulation 42V (Cessation of office).
Cessation of office

"42V. A person ceases to be a member of the Panel if:

   (a)  the person resigns as a member by notice in writing to the Panel; or

   (b)  the body who nominated the member nominates another person to be a
        member in place of the person first mentioned; or

   (c)  the Panel resolves to remove the member. Alternate members

"42W. (1) The chairperson may appoint a person who is not a member of the
panel to be the alternate chairperson of the Panel.

"(2) A body mentioned in paragraph 42T (1) (b), (c) or (d) may appoint a
person who is not a member of the Panel to be the alternate of a member
nominated to the Panel by that body.

"(3) If a member (including the chairperson) is absent from a meeting of the
Panel, the member's alternate (if any) is entitled to attend the meeting and,
when so attending, is taken to be a member of the Panel.

"(4) If a person ceases to hold office as a member:

   (a)  the person who was the person's alternate immediately before the
        person ceased to hold office is entitled to attend meetings of the
        Panel while the office is vacant and, when so attending, is taken to
        be a member of the Panel; and

   (b)  the person is taken to be the alternate of a person nominated to the
        vacant office until a new alternate is appointed.

"(5) A person appointed by a body as an alternate may resign the appointment
by notice in writing to the body. Observers to Panel

"42X. (1) The Therapeutic Goods Administration must nominate a person to
attend meetings of the Panel as an observer.

"(2) The Australia New Zealand Food Authority may nominate a person to attend
meetings of the Panel as an observer.

"(3) A person nominated as an observer is entitled, until the nomination is
revoked:

   (a)  to be given the agenda and minutes of Panel meetings, as if the person
        were a member of the Panel; and

   (b)  by notice in writing to the chairperson suggest agenda items to be
        considered by the Panel; and

   (c)  to attend meetings of the Panel and vote on any question in accordance
        with regulation 42Z. Quorum

"42Y. At a meeting of the Panel, a quorum consists of the following persons:

   (a)  the chairperson;

   (b)  the member nominated by the NFAA;

   (c)  the member nominated by the PMAA;

   (d)  a health care professional member mentioned in paragraph 42T (1) (d);

   (e)  the person nominated as an observer by the Therapeutic Goods
        Administration under regulation 42X. Meetings

"42Z. (1) Meetings of the Panel are to be held at the times and places that
the chairperson directs.

"(2) The chairperson is to preside at meetings of the Panel at which he or she
is present.

"(3) If the chairperson or chairperson's alternate is absent from a meeting, a
member nominated by the chairperson or, if no member is nominated, a member
chosen by the members of the Panel present at the meeting, is to preside.

"(4) A question arising at a meeting of the Panel is to be decided by a
majority of the votes of the members and observers present and voting, with
the person presiding at the meeting having a casting vote.

"(5) An observer is entitled to vote at a meeting on any question affecting
the interests of the body nominating the observer. Effect of vacancy

"42ZA. The exercise of a power or performance of a function of the Panel is
not affected by any vacancy in the membership of the Panel. Disclosure of
interest

"42ZB. (1) A member of the Panel (including a person taken to be a member
under regulation 42W) who has a direct or indirect pecuniary interest in a
matter being considered or about to be considered at a meeting of the Panel
must, as soon as possible after the relevant facts have come to the member's
knowledge, disclose the nature of the interest at a meeting of the Panel.

"(2) The disclosure is to be recorded in the minutes of the meeting and the
member must not, unless the Panel otherwise determines:

   (a)  be present during any deliberation of the Panel with respect to the
        matter; or

   (b)  take part in any decision of the Panel with respect to that matter.

"(3) For the purpose of the making of a determination in relation to the
member who has made the disclosure, any member who has a direct or indirect
pecuniary interest in the matter to which the disclosure relates must not:

   (a)  be present during any deliberation of the Panel for the purpose of
        making the determination; or

   (b)  take part in the making of the determination by the Panel.

"(4) Subregulations (1), (2) and (3) apply to an observer to the Panel who is
intending to take part in any decision of the Panel on a matter as they apply
to a member. Procedure generally

"42ZC. So far as these Regulations do not provide for the procedure of the
Panel, the Panel may determine its own procedure.".