Select Legislative Instrument 2009 No. 374

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2009 (No. 6)

The purpose of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

Subsection 63(1) of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act, or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

Paragraph 63(2)(a) of the Act provides that regulations made by the Governor-General under subsection 63(1) of the Act may make provision in relation to the establishment of committees to advise the Minister for Health and Ageing (the Minister) or the Secretary of the Department of Health and Ageing (the Secretary) on matters relating to therapeutic goods, the functions and powers of those committees and the payment of remuneration and allowances to members of those committees.

The Regulations amend the Therapeutic Goods Regulations 1990 (the Principal Regulations), to replace a number of existing statutory advisory committees (the old committees) with new statutory advisory committees (the new committees), each of which deal with similar matters to the corresponding old committee. A new statutory Advisory Committee on the Safety of Medicines is also established in relation to the provision of technical advice and recommendations on the safety of medicines, in particular in relation to adverse reactions of medicines.

Details of each of the relevant old committees and the corresponding new committees that are established by the Regulations are set out in the table at Attachment A (with the exception of the Therapeutic Goods Committee, which will retain its existing name).

The Regulations are set out two Schedules. Schedule 1 to the Regulations establish all the new advisory committees (including their functions and membership), except the Advisory Committee on Complementary Medicines. It also establishes a new Division under Part 6 of the Principal Regulations in respect of general procedural matters applying to these committees such as appointment of the chair of the committee, termination of committee members, committee procedures at meetings, when and how meetings are held and other miscellaneous procedural matters. Schedule 1 to the Regulations commence on 1 January 2010.

Schedule 2 to the Regulations establish and set out the functions and powers of the Advisory Committee on Complementary Medicines and makes consequential amendments. Schedule 2 to the Regulations commence on 25 January 2010.

Schedule 2 to the Regulations also make consequential amendments in relation to Part 6-4 of the Act, which establishes Complementary Medicines Evaluation Committee (CMEC) (Part 6-4 of the Act establishes CMEC, and Division 4 of Part 6 of the Principal Regulations sets out the functions and powers of that committee). This Part will be repealed on 25 January 2010 by Part 2 of Schedule 7 to the Therapeutic Goods Amendment (2009 Measures No.1) Act 2009

(the Amendment Act).

The Regulations also make a consequential amendment on a matter relating to the advertising of therapeutic goods by prescribing committees for the purposes of new paragraph 42DF(4)(b) of the Act, which will commence on 25 January 2010.

The Regulations are intended to improve the operation of the TGA’s external committees by providing greater consistency across their processes and flexibility in their administration. The Regulations are also intended to support greater transparency of the TGA’s external committees by providing for persons with expertise in consumer issues to be members of the new Advisory Committee on Prescription Medicines and the new Advisory Committee on the Safety of Medicines (consumer experts were able to be members the Therapeutic Goods Committee, the Medicines Evaluation Committee, the Medical Devices Evaluation Committee and the Complementary Medicines Evaluation Committee, and this capacity is preserved in respect of the relevant corresponding new committees to those old committees), and mandating that the new committees must make all their recommendations (both positive and negative) public. The Regulations also amend the names of the new committees to clarify that these committees are advisory in nature.

Details on of the Regulations are set out in Attachment B.

Consultation

The proposed changes to the TGA’s external committees were to have been implemented as part of the now postponed Australia New Zealand Therapeutic Products Authority (ANZTPA). The establishment of ANZTPA was suspended on 16 July 2007 following an announcement by the then New Zealand State Services Minister, Annette King, that the New Zealand Government was not able to proceed with the legislation to establish the Authority due to insufficient numbers in Parliament.

The Government in 2008 agreed to implement improvements identified during the development of ANZTPA in an Australia-only context.

Draft legislation covering the now suspended ANZTPA was subject to extensive public consultation. The TGA also convened a series of consultation sessions in late July-early August 2008 to inform stakeholders of the current set of proposals to reform the domestic regulatory framework for therapeutic goods. This included the improved arrangements for the TGA’s external committees.

The proposed changes to the TGA’s external committees have been refined with some minor modifications necessary for implementation in an Australia-only context.

The Act specifies no conditions that need to be met before the power to make the Regulations may be exercised.

The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.

Schedule 1 of the Regulations commences on 1 January 2010 and Schedule 2 of the Regulations commences on 25 January 2010.

ATTACHMENT A

TABLE SETTING OUT DETAILS OF OLD COMMITTEES AND CORRESPONDING NEW COMMITTEES

ATTACHMENT B

DETAILS OF THE THERAPEUTIC GOODS AMENDMENT REGULATIONS 2009 (No. 6)

Regulation 1 – Name of Regulations

This regulation provides that the name of the Regulations is the Therapeutic Goods Amendment Regulations 2009 (No. 6).

Regulation 2 - Commencement

This regulation provides that the Regulations commence as follows: (a) on 1 January 2010 for regulations 1 to 4 and Schedule 1; and (b) on 25 January 2010 for Schedule 2.

Regulation 3 – Amendment of Therapeutic Goods Regulations 1990

This regulation provide that the Therapeutic Goods Regulations 1990 (the Principal Regulations) are amended as set out in Schedules 1 and 2.

Regulation 4 – Transitional

This regulation sets out the transitional arrangements which are intended to ensure a smooth transition from the old to the corresponding new committees.

SCHEDULE 1 –Amendments

Item [1] – Part 6, Division 1

Item 1 substitutes Division 1 in Part 6 of the Principal Regulations with new Divisions 1, 1A to 1D and 1F consisting of regulations 34 to 42.

Divisions 1, 1A, 1B, 1C and 1D establish, respectively, the Therapeutic Goods Committee, the Advisory Committee on Prescription Medicines, the Advisory Committee on

Non-prescription Medicines, the Advisory Committee on the Safety of Medicines and the Advisory Committee on Medical Devices. These expert committees provide advice and make recommendations to the Minister or Secretary about the specific matters set out under their functions.

Division 1F sets out general provisions applicable to the committees mentioned in Divisions 1 and 1A to 1D, in relation to such matters as appointment of the chair of committees, committee procedures and when and how meetings are to be held.

Division 1– Therapeutic Goods Committee

Regulation 34 - Establishment

Regulation 34 establishes the Therapeutic Goods Committee.

Regulation 34A - Functions

Subregulation 34A(1) provide that the functions of the Therapeutic Goods Committee are to advise and make recommendations to the Minister about the adoption of standards for therapeutic goods, matters relating to standards for therapeutic goods, requirements for labelling and packaging of therapeutic goods, standards for manufacture of therapeutic goods, matters relating to medical device standards, matters relating to conformity assessment standards and matters referred to the committee by the Minister or Secretary.

Subregulation 34A(2) requires the committee to give to the Minister or Secretary the reasons for any advice of the committee. Additionally, the committee, when considering matters relating to subregulation 34A(1) above, is required to take into account the desirability of adopting any default standards or other recognised international standards for therapeutic goods in the interests of international harmonisation of therapeutic goods standards and whether the application of those standards to Australian conditions is appropriate.

Subregulation 34A(3) allows the Minister or Secretary to require the committee to give its advice to other persons or bodies.

Subregulation 34A(4) makes it clear that the committee must publish its recommendations.

In that regard, the committee’s recommendations may be published on the Therapeutic Goods Administration’s website. It is not intended that business or other protected information under the Freedom of Information Act 1982 (the FOI Act), such as commercial information, be released to the public where this information forms part of the committee’s recommendations.

Regulation 34B - Membership

Regulation 34B sets out the membership details for the Therapeutic Goods Committee.

Subregulation 34B(1) authorises the Minister to appoint, in writing, up to 12 persons as members of the committee in accordance with subregulation 34B(2).

Subregulation 34B(2) sets out that each member of the committee must be a person who either is representative of a specified body or who has expertise in a required field.

Paragraph 34B(2)(a) sets out that representative members of the committee must be a person nominated to the Minister in writing by a body that represents, or a combination of bodies that together represent, the interests of Australian manufacturers of prescription medicine products, Australian manufacturers of non‑prescription medicine products, Australian manufacturers of complementary medicines, Australian manufacturers of medical devices and other therapeutic goods; and consumers of health services.

Paragraph 34B(2)(b) provides that the expert members of the committee must have expertise in at least one of the six fields of expertise set out in this paragraph. The fields of expertise in this regard are microbiology and virology, biomedical engineering, biological safety of biomaterials, biotechnology, pharmaceutical science or community or hospital pharmacy practice. Some members therefore may have expertise in a combination of these fields of expertise but it does not mean that a person with an expertise in only one of those fields cannot be a member of the committee.

Division 1A – Advisory Committee on Prescription Medicines

Regulation 35 - Establishment

New regulation 35 establishes the Advisory Committee on Prescription Medicines.

Regulation 35A - Functions

Subregulation 35A(1) provides that the functions of the Advisory Committee on Prescription Medicines are to advise and make recommendations to the Minister or Secretary on the inclusion of a prescription medicine in the Australian Register of Therapeutic Goods (the Register), variation of an entry in the Register relating to a prescription medicine, removal or the continued retention of a prescription medicine in the Register, any other matter concerning a prescription medicine and any other matters referred to it by the Minister or Secretary (whether or not related to a prescription medicine).

Subregulation 35A(2) allows the Minister or Secretary to require the committee to give its advice to other persons or bodies.

Subregulation 35A(3) makes it clear that the committee must publish its recommendations.

In that regard, the committee’s recommendations may be published on the Therapeutic Goods Administration’s website. It is not intended that business or other protected information under the FOI Act, such as commercial information, be released to the public where this information forms part of the committee’s recommendations.

Regulation 35B - Membership

Regulation 35B sets out the membership details for the Advisory Committee on Prescription Medicines.

Subregulation 35B(1) authorises the Minister to appoint, in writing, up to 25 persons as members of the committee in accordance with subregulations 35B(2) and 35B(3). Not all these members are invited by the Chair to attend each meeting. Some members with expertise in specialised medical or scientific fields are not always required to advise or vote upon matters to be considered at committee meetings.

Subregulation 35B(2) provides that each member of the committee must have expertise in at least one of the fields of expertise set out in this subregulation. The fields of expertise include general medical practice in Australia, consumer issues, epidemiology or biostatistics, clinical pharmacology or pharmacokinetics etc. Some members therefore may have expertise in a combination of those fields of expertise listed but it does not mean that a person with an expertise in only one of those fields cannot be a member of the committee.

Subregulation 35B(3) requires that the membership of the committee must, to the extent reasonably practicable, represent the widest possible range of fields mentioned in subregulation 35B(2).

Division 1B – Advisory Committee on Non-prescription Medicines

Regulation 36 - Establishment

New regulation 36 establishes the Advisory Committee on Non-prescription Medicines.

Regulation 36A - Functions

Subregulation 36A(1) provides that the functions of the Advisory Committee on

Non-prescription Medicines are to advise and make recommendations to the Minister or Secretary on the inclusion of a non-prescription medicine in the Register, variation of an entry in the Register relating to a non-prescription medicine, removal or the continued retention of a non-prescription medicine in the Register, any other matter concerning a

non-prescription medicine and any other matters referred to it by the Minister or Secretary (whether or not related to a non-prescription medicine).

Subregulation 36A(2) allows the Minister or Secretary to require the committee to give its advice to other persons or bodies.

Subregulation 36A(3) makes it clear that the committee must publish its recommendations.

In that regard, the committee’s recommendations may be published on the Therapeutic Goods Administration’s website. It is not intended that business or other protected information under the FOI Act, such as commercial information is to be released to the public where this information forms part of the committee’s recommendations.

Regulation 36B - Membership

Regulation 36B sets out the membership details for the Advisory Committee on

Non-prescription Medicines.

Subregulation 36B(1) authorises the Minister to appoint, in writing, up to 12 persons as members of the committee in accordance with subregulations 36B(2) and 36B(3).

Subregulation 36B(2) provides that each member of the committee must have expertise in at least one of the nine fields of expertise set out in this subregulation. The fields of expertise include general medical practice in Australia, specialist medical practice of a kind relevant to the committee’s functions, pharmaceutical chemistry, consumer issues etc. Some members therefore may have expertise in a combination of those fields of expertise listed but it does not mean that a person with an expertise in only one of those fields cannot be a member of the committee.

Subregulation 36B(3) require that the membership of the committee must, to the extent reasonably practicable, represent the widest possible range of fields mentioned in subregulation 36B(2).

Division 1C – Advisory Committee on the Safety of Medicines

Regulation 37 - Establishment

New regulation 37 establishes the Advisory Committee on the Safety of Medicines.

Regulation 37A - Functions

Subregulation 37A(1) provides that the functions of the Advisory Committee on the Safety of Medicines are to advise and make recommendations to the Minister or Secretary on the safety of medicines, risk assessment and risk management of medicines, other matters related to pharmacovigilance and any other matters referred to it by the Minister or Secretary (whether or not related to medicines safety).

Subregulation 37A(2) allows the Minister or Secretary to require the committee to give its advice to other persons or bodies.

Subregulation 37A(3) makes it clear that the committee must publish its recommendations. In that regard, the committee’s recommendations may be published on the Therapeutic Goods Administration website. It is not intended that business or other protected information under the FOI Act, such as commercial information, be released to the public where this information forms part of the recommendations.

Regulation 37B - Membership

Regulation 37B sets out the membership details for the Advisory Committee on the Safety of Medicines.

Subregulation 37B(1) authorises the Minister to appoint, in writing, up to 12 persons as members of the committee in accordance with subregulations 37B(2) and 37B(3).

Subregulation 37B(2) provides that each member of the committee must have expertise in at least one of the ten fields of expertise set out in this subregulation. The fields of expertise include pharmacoepidemiology, clinical pharmacology, clinical pharmacy, consumer issues etc. Some members therefore may have expertise in a combination of those fields of expertise listed but it does not mean that a person with an expertise in only one of those fields cannot be a member of the committee.

Subregulation 37B(3) requires that the membership of the committee must, to the extent reasonably practicable, represent the widest possible range of fields mentioned in subregulation 37B(2).

Division 1D – Advisory Committee on Medical Devices

Regulation 38 - Establishment

New regulation 38 establishes the Advisory Committee on Medical Devices.

Regulation 38A - Functions

Subregulation 38A(1) provides that the functions of the Advisory Committee on Medical Devices are to advise and make recommendations to the Minister or Secretary on the inclusion of a medical device in the Register, variation of an entry in the Register relating to a medical device, removal or the continued retention of a medical device in the Register, any other matter concerning a medical device and any other matters referred to it by the Minister or Secretary (whether or not related to a medical device).

Subregulation 38A(2) allows the Minister or Secretary to require the committee to give its advice to other persons or bodies.

Subregulation 38A(3) makes it clear that the committee must publish its recommendations. In that regard, the committee’s recommendations may be published on the Therapeutic Goods Administration’s website. It is not intended that business or other protected information under the FOI Act, such as commercial information, is to be released to the public where this information forms part of the recommendations.

Regulation 38 - Membership

Regulation 38B sets out the membership details for the Advisory Committee on Medical Devices.

Subregulation 38B(1) authorises the Minister to appoint, in writing, up to 32 persons as members of the committee in accordance with subregulation 38B(2). Not all these members are invited by the Chair to attend each meeting. Some members with expertise in specialised medical or scientific fields are not always required to advise or vote upon matters to be considered at committee meetings.

Subregulation 38B(2) provides that each member of the committee must have expertise in at least one of the fields of expertise set out in this subregulation. The fields of expertise include medical or surgical expertise, manufacture of medical devises, consumer issues etc. Some members therefore may have expertise in a combination of those fields of expertise listed but it does not mean that a person with an expertise in only one of those fields cannot be a member of the committee.

Subregulation 38B(3) requires that the membership of the committee must, to the extent reasonably practicable, represent the widest possible range of fields mentioned in subregulation 38B(2).

Division 1F – General

Regulation 40 – Application of this Division

Regulation 40 makes it clear that Division 1F applies to committees mentioned in Divisions 1 and 1A to 1D of the Principal Regulations.

Regulation 41 – Appointment of members

Regulation 41 sets out requirements relating to the appointment of members of committees to which Division 1F applies.

Subregulation 41(1) provides that a member is appointed to a committee for a term stated in the member’s instrument of appointment.

Subregulation 41(2) notes that a term of appointment must not be longer than three years.

Further, subregulation 41(3) prohibits a member, other than a member mentioned in subregulation 41(4), from being appointed for more than three consecutive terms.

Subregulation 41(4) provides that a member appointed to a committee before the commencement of subregulation 41 must not be appointed for more than three further consecutive terms.

Regulation 41A – Appointment of the chair

Regulation 41A provides that the Minister must appoint, in writing, a member of a committee to be the committee’s chair.

Regulation 41B – Resignation or vacancy

Subregulation 41B(1) provides that a member or chair may resign by giving written notice to the Minister. Subregulation 41B(2) provides that if a chair ceases to a member of a committee, the position of chair of the committee is taken to be vacant.

Regulation 41C – Termination of appointment

Regulation 41C sets out requirements regarding the termination of the appointment of members.

Subregulation 41C(1) provides that the Minister may terminate a member’s appointment on any of a number of specified grounds, those being physical or mental incapacity, misbehaviour, incompetence, inefficiency, bankruptcy or failing to comply with the disclosure of interest requirements mentioned in regulation 42.

Subregulation 41C(2) requires that the Minister must terminate a member’s appointment if the member is convicted of an offence punishable by imprisonment for at least one year, or if the member is absent without leave of absence from three consecutive meetings of the committee.

Regulation 41D – Leave of absence

Subregulation 41D(1) permits the Minister to grant leave of absence to the chair.

Subregulation 41D(2) permits the chair to grant leave of absence to another committee member.

Regulation 41E – Acting members

Regulation 41E deals with acting members.

Subregulation 41E(1) permits the Minister to appoint a person to act as a member of a committee.

Subregulation 41E(2) provides that a person may act as a member of a committee during a vacancy in the office – whether or not an appointment has previously been made to the office, or during any period, or during any periods, when the holder of the office is absent from duty or is, for any reason, unable to perform the duties of the office.

Subregulation 41E(3) provides that a person appointed to act in an office must, to the extent reasonably practicable, hold a qualification if that particular qualification is required for a substantive member or - if different qualifications are required for all members of the committee - hold one of those qualifications.

Subregulation 41E(4) specifies that a person appointed to act during a vacancy must not continue to act for more than 12 months.

Regulation 41F – Committee procedures

Regulation 41F sets out a number of requirements and powers relating to committee procedures.

Regulation 41F requires that in performing its functions, a committee must act in accordance with Division 1F and with as little formality and as quickly as Division 1F and a proper consideration of the issues before the committee allow, and must comply with any directions given, in writing, to the committee by the Minister or the Secretary about the committee’s performance of its functions (other than a direction about advice given or to be given by the committee).

Regulation 41F also provides that, in performing its functions, a committee is not bound by the rules of evidence, may obtain information about an issue in any way it considers appropriate (subject to subregulation 42(9), discussed below) and may receive information or submissions orally or in writing.

Regulation 41G - Meetings

Regulation 41G sets out requirements regarding the holding of meetings by committees.

Subregulation 41G(1) provides that the chair of a committee may give written notice to the committee or to some members of the committee, directing the committee or those members to hold meetings at the times and places, and to deal with the matters in the manner stated in the notice. As the fields of expertise in which members of the committees to which Division 1F applies may be specialised, there may not be a need for all members to attend every meeting of each such committee. Subregulation 41G(1) therefore, is intended, among other things, to enable the chair of a committee to direct to attend a meeting those members of the committee whose expertise is required in order to adequately consider the matters before the committee at that meeting.

Subregulation 41G(2) requires that the procedure of a meeting must be determined by the committee in accordance with Division 1F.

Regulation 41H – Presiding member

Regulation 41H sets out arrangements relating to the need for a presiding member at committee meetings.

Subregulation 41H(1) requires that the chair must preside at a committee meeting or nominate a member of the committee to preside at the meeting.

Subregulation 41H(2) provides that if the chair is temporarily absent from a meeting, the member chosen by the members present must preside at the meeting. Subregulation 41H(3) enables a member chosen to preside under subregulation 41H(2) to exercise the powers and functions of the chair.

Regulation 41I - Quorum

Regulation 41I sets out arrangements in relation to determining when a quorum exists at a committee meeting. Regulation 41I provides that a quorum exists at a committee meeting when either at least half of the members are present, or at least half of the members who have been directed under subregulation 41G(1) to hold the meeting are present.

Regulation 41J - Voting

Regulation 41J sets out arrangements in relation to voting at committee meetings.

Subregulation 41J(1) provides that a decision made at a committee meeting by a majority of the votes of the members present and voting is a decision of the committee.

Subregulation 41J(2) provides that the member presiding at a committee meeting has a deliberative vote and, if the votes are equal, also has a casting vote.

Regulation 42 - Miscellaneous

Regulation 42 sets out arrangements and requirements on a number of miscellaneous matters relating to the establishment of the new committees.

Subregulation 42(1) deals with sitting fees and travel entitlements, and provides that a member is entitled to sitting fees and travel entitlements as determined by the Remuneration Tribunal.

Subregulations 42(2) and 42(3) deal with when a committee may establish subcommittees.

Subregulation 42(2) provides that a committee, with the approval of the National Manager of the Therapeutic Goods Administration, may establish subcommittees, consisting of members and other persons. Subregulation 42(3) provides that the function of the subcommittee is to inquire into, and report to the committee on, any matter referred to the subcommittee that is within the functions of the committee.

Subregulations 42(4) to 42(7) are concerned with requirements relating to the disclosure of interests by committee members.

Subregulation 42(4) requires that a member of a committee who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered or about to be considered at a meeting of the committee must, without delay, disclose the nature of the interest at, or before, the meeting of the committee.

Subregulation 42(5) requires that the disclosure must be recorded in the minutes of the meeting and the member must not, unless the committee otherwise determines, either be present during any deliberation of the committee about the matter or take part in any decision of the committee about that matter.

Subregulation 42(6) requires that when a committee is making a determination about a member who has made a disclosure, the member, and any other member who has a direct or indirect pecuniary interest in the matter to which the disclosure relates, must not either be present during any deliberation of the committee or take part in making the determination.

Subregulation 42(7) applies disclosure requirements to subcommittees, and notes that a member of a subcommittee appointed by a committee, who is aware that he or she has a direct or indirect material personal interest (whether pecuniary or not) in a matter being considered, or about to be considered, at the meeting of the subcommittee must, without delay, disclose the nature of the interest at, or before, the meeting of the subcommittee.

Subregulations 42(8) and 42(9) deal with arrangements regarding the seeking of further advice by a committee.

Subregulation 42(8) sets out that any advice or recommendation given by a committee to the Minister or the Secretary may given to another expert advisory committee for the advice of that committee.

Subregulation 42(9) provides that a committee may, in performing its functions, seek advice from other persons.

Subregulation 42(10) deals with the validity of acts of members or purported members of committees in specified circumstances.

Subregulation 42(10) provides that anything done by a person purporting to be or act as a member (including a chair) is not invalid because the person has not yet been appointed, or there is a defect or irregularity in connection with the person’s appointment or the person’s appointment had ceased to have effect.

Subregulation 42(11) deals with records and reports of committees, and requires that a committee must keep a record of its proceedings, and must prepare any other report about its activities that is requested by the Minister or the Secretary.

Item [2] – Part 6, Division 5

Item 2 omits Division 5 of Part 6 of the Principal Regulations. This Division establishes the Medicines Evaluation Committee, which is to be replaced with the Advisory Committee on Non-prescription Medicines.

SCHEDULE 2 - Amendments

Item [1] – Regulation 2, definition of active ingredient

Item 1 substitutes a new definition of “active ingredient” in regulation 2 as Part 6-4 of the Therapeutic Goods Act 1989 (the Act) (which includes a definition of “active ingredient” in section 52F, to which the current definition of “active ingredient” in regulation 2 refers) will be repealed on 25 January 2010 - the same time as the commencement of this Schedule.

The definition of “active ingredient” that is inserted in regulation 2 is consistent with the current definition of that term in section 52F of the Act. Part 6-4 of the Act will be repealed by the commencement Part 2 of Schedule 7 to the Therapeutic Goods Amendment (2009 Measures No.1) Act 2009.

Item [2] – Regulation 2, definition of complementary medicines and traditional use

Item 2 omits the definitions of “complementary medicines” and “traditional use” from regulation 2 of the Regulations. Both of those definitions refer to a section of the Act (section 52F) that will be repealed. Part 6-4 of the Act, which deals with complementary medicines and which includes section 52F, will be repealed on 25 January 2010. The definitions applying to the complementary medicines regulatory framework are currently under review. Amended definitions of “complementary medicine” and “traditional use” are likely to be included in the Principal Regulations following that review.

Item [3] – After regulation 6

Item 3 inserts a new regulation 6AA in Division 3 of Part 2 of the Principal Regulations, which sets out general provisions about advertising therapeutic goods.

This amendment is required as it is consequential on the repeal of paragraph 42DF(4)(b) of the Act.

Currently, subsection 42DF(4) of the Act provides that in deciding whether to approve or refuse to approve the use of restricted representation, the Secretary must take into consideration any recommendation of the Therapeutic Goods Advertising Code Council, any advice of the Complementary Medicines Evaluation Committee or the Medicines Evaluation Committee and the public interest criteria mentioned in a part of the Therapeutic Goods Advertising Code that is prescribed by the Principal Regulations made for the purposes of this paragraph.

Paragraph 42DF(4)(b) of the Act is to be repealed and substituted with the following wording by item 53 of Part 2 of Schedule 7 to the Amendment Act:

“(b) any advice of a committee that is established under the regulations and is prescribed by the regulations for the purposes of this paragraph”.

Part 2 of Schedule 7 to the Amendment Act will commence by Proclamation, which is to be proclaimed for that purpose is 25 January 2010, the same date that Schedule 2 to the Regulations commence.

New subregulation 6AA provides that for paragraph 42DF(4)(b), the Advisory Committee on Non-prescription Medicines and the Advisory Committee on Complementary Medicines are prescribed.

Item [4] – Part 6, after Division 1D

Item 4 inserts a new Division 1E into Part 6 of the Principal Regulations consisting of regulations 39 to 39B. Division 1E deals with arrangements for the Advisory Committee on Complementary Medicines.

Regulation 39 - Establishment

New regulation 39 establishes the Advisory Committee on Complementary Medicines.

Regulation 39A – Functions

Subregulation 39A(1) provides that the functions of the Advisory Committee on Complementary Medicines are to advise and make recommendations to the Minister or Secretary on the inclusion of a complementary medicine in the Register, variation of an entry in the Register relating to a particular complementary medicine, removal of or the continued retention of a complementary medicine in the Register, any other matter concerning a complementary medicine and any other matters referred to it by the Minister or Secretary (whether or not related to a complementary medicine).

Subregulation 39A(2) allows the Minister or Secretary to require the committee to give its advice to other persons or bodies.

Subregulation 39A(3) makes it clear that the committee must publish its recommendations.

In that regard, the committee’s recommendations may be published on the Therapeutic Goods Administration’s website. It is not intended that business or other protected information under the FOI Act, such as commercial information be released to the public where this information forms part of the recommendations.

Regulation 39B - Membership

Regulation 39B sets out the membership details for the Advisory Committee on Complementary Medicines.

Subregulation 39B(1) authorises the Minister to appoint, in writing, up to 12 persons as members of the committee in accordance with subregulations 39B(2), 39B(3) and 39B(4).

Subregulation 39B(2) provides that each member of the committee must have expertise in at least one of the eleven fields of expertise set out in this subregulation. The fields of expertise include complementary medical practice, manufacture of medicines, consumer issues, general medical practice in Australia, etc. Some members therefore may have expertise in a combination of those fields of expertise listed but it does not mean that a person with an expertise in only one of those fields cannot be a member of the committee.

Subregulation 39B(3) requires that at least four of the members of the committee have clinical experience in one of the fields mentioned in subregulation 39B(2).

Subregulation 39B(4) requires that the membership of the committee must, to the extent reasonably practicable, represent the widest possible range of fields mentioned in subregulation 39B(2).

Item [5] – Regulation 40

Item 5 amends new regulation 40 which is to be inserted by Schedule 1 of the Regulations on 1 January 2010, to include a reference to Division 1E relating to the new Advisory Committee on Complementary Medicines.

Item [6] – Part 6, Division 4

Item 6 of Schedule 2 is a consequential amendment made necessary by item 4 of Schedule 2 (described above). Part 6, Division 4 of the Principal Regulations, which sets out the functions and powers of the Complementary Medicines Evaluation Committee, is repealed, as a new Advisory Committee on Complementary Medicines is established under new

Division 1E of Part 6 of the Principal Regulations.