Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 1999 (NO. 1) 1999 NO. 62

Statutory Rules 1999 No. 62

issued by the Authority of the Minister for Health and Aged Care

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 1999 (No. 1)

Subsection 63(1) of the therapeutic Goods Act 1989 (the Act) provides that the Governor-General may make regulations prescribing matters required or permitted to be prescribed or necessary or convenient for carrying out or giving effect to the Act.

Paragraph 63(2)(a) provides that the regulations may make provision in relation to the establishment of committees to advise the Minister or the Secretary of the Department on matters relating to therapeutic goods, and the functions and powers of those committees.

Subsections 52G(2) and 52G(3) further provide That the Complementary Medicines Evaluation Committee is to have the functions prescribed in the regulations in relation to complementary medicines and the Committee is to be constituted, and to hold meetings and to make recommendations, in accordance with the regulations.

The purpose of the amendments to the Regulations is to:

* make consequential amendments to the Regulations as a result of recent changes to the Act. The consequential amendments:

> amend a number of definitions in The Regulations to make these consistent with definitions included in the Act and to provide a better interface between foods, complementary medicines and other medicines (Items 17, 17 and 18); and

> omit regulation 5D (Publishing advertisements without approval etc) and regulation SE (Publication by a publisher of advertisements) which have been incorporated in the Act (Items 8-10);

*       insert a new division in the Regulations. for the purposes of section 52G of the Act, which describes the functions of the Complementary Medicines Evaluation Committee and how the Committee will be constituted, hold meetings and make recommendations (Item 11); and

*       make minor amendments to existing regulations to clarify the intent of those regulations and improve understanding of the application of the provisions (Items 12-15).

The amendments have been developed with the cooperation and support of the Parliamentary Secretary's Complementary Medicines Working Party, the Complementary Health Care Council of Australia and the Proprietary Medicines Association of Australia.

Further details of the regulations are set out in the Attachment.

The regulations commence on gazetal.

ATTACHMENT

DETAILS OF THERAPEUTIC GOODS AMENDMENT REGULATIONS

Regulation 1 (Name of regulations)

This is a formal provision that specifies the title of the Regulations as the Therapeutic Goods Amendment Regulations 1999. (No. 1).

Regulation 2 (Commencement)

This provision provides that the Regulations will commence on gazettal,

Regulation 3 (Amendment of Therapeutic Goods Regulations 1990)

This provision provides that Schedule 1 amends the Therapeutic Goods Regulations 1990.

SCHEDULE 1 AMENDMENTS

Item 1 omits the definition of "drugs", "poison" and "Poisons Standard" from Regulation 2. The definitions have been replaced with new definitions in the Act.

Items 2 and 3 redefine "active ingredient" and "orphan drug" to reflect changes made to the Act which incorporate a definition for "active ingredient" and in the definition of "orphan drug" substitute the word "drug" with "medicine".

Item 4 inserts into regulation 2, definitions for "complementary medicines", "Complementary Medicines Evaluation Committee" and "traditional use". Each of the terms has the same meaning as is accorded to those terms in the Act.

Item 5 inserts a note after regulation 2 which states that the definitions of "medicine" and "poison" are in the Act (subsection 3(1)).

Item 6 omits from regulation 5B the definitions of "approval number", "complementary medicine", "complementary use", "designated active ingredient", "mainstream media" and "traditional use". These terms have been included in the Act or are no longer necessary as a result of changes to definitions in the Act.

Item 7 provides that the new definition of "approved advertisement" is as described in section 42B of the Act.

Items 8 and 9 omit regulations 5D and SE. These regulations have been incorporated into the Act.

Item 10 omits the reference to regulation 5D in paragraph 5L(1)(b) and replaces it with a reference to section 42C of the Act. This reflects the removal of regulation 5D from the Regulations and incorporation of that provision in the Act

Item 11 inserts into the Regulations a new Division, Division 4, which describes the functions, constitution and procedures for the Complementary Medicines Evaluation Committee.

Regulation 42ZD (Definition)

This regulation provides that in this Division, "Committee" means the Complementary Medicines Evaluation Committee as established by section 52G of the Act

Regulation 42ZE (Committee's evaluating function)

This regulation describes the evaluating function of the Committee. The Committee may. undertake evaluations (which may include scientific and medical evaluations) and report to the Minister or Secretary about a complementary medicine, an ingredient in a complementary medicine, a kind of ingredient in a complementary medicine and a therapeutic good specified by the Minister or the Secretary. The regulation further provides that when the Committee makes a report they may make a recommendation about;

- whether or not a complementary medicine should remain in the Register,

- whether or not a complementary medicine should be included in the Register; and

- whether or not an ingredient or kind of ingredient should be included in Schedule 14, or mentioned in Schedule 4, as the therapeutically active ingredient in a preparation mentioned in item 3 of Part 1 of that Schedule.

Reputation 42ZF (Committee may give advice to Minister or Secretary)

Subregulation 42ZF(1) provides that, in relation to any of the things mentioned in subregulation 42ZE(1) (complementary medicines, ingredients and kinds of ingredients in complementary medicines etc) the Committee may provide advice to the Minister or Secretary about the import, export, registration, listing manufacture, supply and use of that thing. As part of the Committee's advice giving role it may also develop guidelines for consideration by the Minister or Secretary.

A note has been included in the subregulation which draws attention to the definition of supply in subsection 3(1) of the Act. In summary, "supply' includes supply byway of sale, exchange, gift, lease loan, hire, hire purchase, 'sample or advertisement and supply in the course of testing and by way of administration to a person or animal.

Subregulation 42ZF(2) provides that the Committee may include in its advice to the Minister or Secretary its opinion about safety, quality, efficacy, indications, claims and information or evidence used to support a claim. The Committee may also include its assessment of shortterm and longterm risks and claimed benefits of use of the complementary medicine, ingredient or therapeutic good.

Regulation 42ZG (Committee may establish sub-committees)

This regulation provides that the Committee may appoint sub-committees to inquire into and report to the Committee on matters within the functions of the Committee. The subcommittees may consist of members of the Committee and other persons.

Regulation 42ZH (Minister or Secretary may seek further advice)

This regulation provides that the Minister or the Secretary may give a copy of any advice provided to them by the Committee to another Committee established under Division 1 of Part 6. The Committee to which a copy of an advice is given may make comments to the Minister or the Secretary about that advice.

Regulation 42ZI (Committee may seek advice and assistance)

This regulation provides that the Committee may, in performing its functions, seek advice from other persons.

Regulation 42ZJ (Establishment and membership of Committee)

This regulation provides that the Complementary Medicines Evaluation Committee is constituted in accordance with subdivision 3.

Regulation 42ZK (Appointment of Committee Members)

This regulation provides that the Minister must appoint members in accordance with this regulation, that an appointment must be in writing and that the Committee must include at least 8, but no more than 12, members

Regulation 42ZL (Expertise and experience of members)

This regulation provides that, in appointing members to the Committee, the Minister must take into account the candidates' expertise and experience in a number of fields. Ten different fields have been listed in the regulation, ranging from consumer representation to complementary medicine practice. While it is not intended that any one member need necessarily possess experience in more than one or two of the fields listed, it is considered important that the Committee comprises members with a broad cross section of relevant skills and experience.

Subregulation 42ZL(2) provides that at least 4 members of the Committee must have professional clinical experience in a field mentioned in subregulation (1).

Regulation 42ZM (Appointment of Chair)

This regulation states that the Minister must appoint a member of the Committee as its Chair.

Regulation 42ZN (Minister may nominate expert advisers

This regulation provides that the Minister may nominate expert advisers to assist the Committee in the performance of its functions. The Minister may nominate up to 8 persons as expert advisers and the Committee may ask these people for advice about the matters included within the Committee's functions.

Subregulation 42ZN(4) provides that certain regulations apply to expert advisers nominated

under this regulations as if they were members of the Committee. The provisions referenced

are 42ZO (Term of appointment), 42ZP (Resignation), 42ZQ (Disclosure of interest) and

42ZR (Termination of appointment).

Regulation 42ZO (Term of appointment)

This regulation provides that a Committee member is appointed for the term stated in the member's appointment and that term must not be greater than three years. A Committee member may, however, be reappointed for further terms of up to three years. The Chair of the Committee is also appointed for the term stated in the appointment and may be reappointed for further terms.

Regulation 42ZP (Resignation)

This regulation provides that a member may resign by signed notice of resignation given to the minister.

Regulation 42ZQ (Disclosure of interests)

This regulation addresses the situation where a matter is being considered, or is about to he considered, at a meeting and a Committee member is aware that he or she may have a direct or indirect pecuniary interest in the matter. The regulation provides that in such a case, the member must, without delay, disclose the nature of the interest at a meeting of the Committee and the disclosure must be recorded in the minutes of the meeting. Once an interest has been identified and recorded. the member must not be present during any deliberations on the matter nor take part in any decision of the Committee about the matter, unless the Committee should decide otherwise. for the purposes of determining whether the 'interested' committee member may participate in any deliberation, or take part in any decision, in the matter in which the Committee member has an interest, the Committee member must not be present during any deliberation on, or take part in deciding, this issue.

It is anticipated that the Committee will also develop more detailed operating guidelines on matters such as disclosure of interest. and possible conflict of interest. Such guidelines my address practical matters such as the recording of possible ongoing interests (that need not be raised at each meeting).

Regulation 42ZR (Termination of appointment

This regulation describes the circumstances under which the Minister may terminate a Committee member's appointment (for example, incompetence, inefficiency or misbehaviour). This is a discretionary power. The regulation also describes more serious circumstances under which the Minister must terminate a member's appointment (for example, conviction of an offence punishable by imprisonment and prolonged absence from meetings without leave). These are circumstances where the Minister has no discretion and must terminate the member's appointment.

Regulation 42ZS (Leave of absence)

This regulation provides that the Minister may grant leave of absence to the Chair of the Committee and the Chair may grant leave to any other member.

Regulation 42ZT (Committee procedure

This regulation provides that this subdivision sets out the procedures that the Committee must follow in holding meetings.

Regulation 42ZU (Committee procedures generally)

Subregulation 42ZU(1) sets out explicitly the general procedures which the Committee must observe when carrying out its functions (for example, the Committee must act in accordance with the regulations with as little formality as possible). The regulation also provides that the Committee is not bound by the rules of evidence, may obtain information in any way it considers appropriate, receive written or oral information and consult anyone it considers appropriate. While the Committee is not bound by the rules of evidence (as is implicitly the case for all Committees of this sort), the Committee will still be expected to observe general procedural rules of fairness and to act at all times in good faith.

Subregulation 42ZU(2) provides that the Minister may issue directions to the Committee about the Committee's performance of its functions and the Committee must comply with such directions. The subregulation does not provide the Minister with the power to direct the outcome of findings or recommendations of the Committee.

Regulation 42ZV (Meetings)

Subregulation 42ZV(1) provides that the Chair may direct the Committee to hold meetings at any time or place, and to deal with matters in a particular manner, stated in a written notice to the Committee.

Subregulation 42ZV(2) provides that subject to these regulations, the Committee may decide the procedure for Committee meetings.

Regulation 42ZW (Presiding member)

This regulation provides that the Chair must preside at a Committee meeting or nominate a member of the Committee to preside at the meeting. If the Chair is temporarily absent from a meeting, the member chosen by the members present must preside.

Regulation 42ZY (Voting)

This regulation provides that at a Committee meeting, half of the appointed members must be present to form a quorum.

Regulation 42ZY (Voting)

This regulation provides that a decision made at a Committee meeting by a majority of the votes of the members present is considered to be a decision of the Committee. This does not mean that all questions arising must be determined by a majority vote. The Committee members may chose not to finalise a Committee decision until consensus has been reached.

Subregulation 42ZY(2) provides that the member presiding at a Committee meeting has a deliberative vote and, in the event of an equality of votes, also has a casting vote.

Regulation 42ZZ (Records and reports

This regulation provides that the Committee must keep a record of its proceedings, and must prepare any other reports requested by the Minister or the Secretary.

Item 12 amends Schedule 4, Part 1, paragraph 3(f) by omitting the term "sold or otherwise distributed" and substituting "supplied". This ensures consistency in use of terms across the legislation. "Supply" is defined in subsection 3(1) of the Act.

Item 13 provides new wording for subparagraph 3(t)(i) of Part l of Schedule 4. This change is necessary as the result of changes described in item 14,

Item 14 provides an improved interpretation for Subdivision 1, Division 2, Part 5, Schedule 4. Consultation with industry revealed that the words used in the existing interpretation and in the table were confusing and could potentially lead to anomalies. As such, it is proposed that the interpretation provision be amended, and an example included, to clarify the intent of Part 5 of the Schedule.

Item 15 amends the heading in column 3, Subdivision 2, Division 2, Part 5, Schedule 4. The change to the heading is necessary as a result of changes to the interpretation of the Division as described in item 14.

Item 16 amends the heading for Part 2, Schedule 10 by replacing "Evaluation by the Complementary Medicines Section of the Department" with "Evaluation by the Office of Complementary Medicines". This reflects changes in the structure of the Therapeutic Goods Administration so that the evaluation of complementary medicines is coordinated by the new Office of Complementary Medicines.

Item 17 amends the heading of Schedule 14 by omitting "(regulation 5B)" and replacing it with "(Act, section 52F)". This reflects the omission of regulation 5B (as per item 7) and the inclusion of that provision in the Act.

Item 18 fists all of the references to "Drug" or "drugs" which are used in the regulations and replaces them with the word "medicine" or "medicines". This is a consequential amendment flowing from the substitution of the word "medicine" for the word "drug" in the Act.