Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 1999 (NO. 2) 1999 NO. 209

Statutory rules 1999 No. 209

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

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 1999 (No. 2)

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) of the Act 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.

Subsection 52B(1) of the Act establishes the National Drugs and Poisons Schedule Committee ("the Committee").

Subsection 52B(2) of the Act provides that the Committee is to be constituted, and to hold meetings and to make decisions, in accordance with the regulations.

Paragraph 52C(g) of the Act further provides that the functions of the Committee include any other functions that are prescribed by the Regulations.

The purpose of the regulations is to make consequential amendments to the Regulations as a result of the inclusion of Part 513 in the Act.

The consequential amendments seek to:

*       insert a new Division in the Regulations that, for the purposes of sections 52B and 52C of the Act, prescribes other functions of the Committee and sets out how the Committee will be constituted, hold meetings and make scheduling decisions; and

*       include transitional provisions to enable the Committee to make decisions at their first meeting in relation to the classification and scheduling of all substances where a decision of that kind has been made by a subcommittee of AHMAC since the publication of the latest edition of the first Poisons Standard.

The amendments have been developed with the cooperation and support of the State and Territory Health Departments and in consultation with the National Registration Authority, the Proprietary Medicines Association of Australia, the Australian Pharmaceutical Manufacturers Association and the Consumer Health Council.

The scheduling decisions of the Committee have minimal effect at the Commonwealth level and have no effect at the State and Territory level until the decisions are adopted into State and Territory legislation.

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

The regulations will commence on gazettal.

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. 2).

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.

Regulation 4 (Transitional)

Subregulation 4(1) provides that for the first meeting of the-National Drugs and Poisons Schedule Committee ("the Committee") a quorum is made up of 5 jurisdictional members, and that public consultation procedures, as set out at subdivision 5 of these Regulations do not apply.

Subregulation 4(2) provides that where AHMAC has made a decision in relation to the classification and scheduling a substance, but that decision does not form part of the first Poisons Standard because the decision was either: (a) made on or after 1 April 1999, or (b) made before 1 April 1999 but had not been published as part of the first Poisons standard; then the Committee must make a decision in relation to all those substances.

Subregulation 4(3) provides that when the Committee is making a decision about a substance, it may accept the findings of AHMAC about the same substance, for the purposes of meeting the requirements of subsection 52E(1) of the Act. The subregulation further provides that the Committee must take account of the scheduling decision of AHMAC for that substance and must take account of the consequences that a decision about a substance at variance with AHMAC's decision would have for industry and the community.

Subregulation 4(4) provides that a word or expression used in both subregulation (2) and in section 52A of the Act has the same meaning.

Subregulation 4(5) provides that in regulation 4; "Act" means the Therapeutic Goods Act 1989; "AHMAC" means the Australian Health Minister's Advisory Council and includes a subcommittee of the Council acting on the Council's behalf, "jurisdictional member" has the same meaning as given in regulation 42ZCE of the principal Regulations; and "principal Regulations" means the Therapeutic Goods Regulations 1990.

SCHEDULE 1 AMENDMENTS

Proposed item 1 inserts into the Regulations a new Division, Division 3 A, which describes further functions of the Committee, the constitution and procedures of the Committee.

Regulation 42ZCA (Definitions for Division 3A)

This regulation provides that in this Division, "Committee" means the National Drugs and Poisons Schedule Committee as established by section 52B of the Act and "jurisdictional member" has the meaning given by regulation 42ZCE.

Regulation 42ZCB (Committee may establish sub-committees)

This regulation provides that the Committee may, subject to the approval of the National Manager in TGA, appoint sub-committees to inquire into, report to, and make recommendations to the Committee on matters within the functions of the Committee. The functions of the Committee are set out at section 52C of the Act. The sub-committees may consist of members of the Committee and other persons, but each subcommittee must comprise at least one member of the Committee.

Regulation 42ZCC (Membership)

This regulation provides that the Committee is constituted in accordance with Subdivision 3.

Regulation 42ZCD (Committee members

Subregulation 42ZCD(1) provides that the Committee comprises jurisdictional members (see 42ZCE) and other persons appointed under this regulation.

Subregulation 42ZCD(2) provides that the Minister may appoint experts or representatives as members.

Subregulation 42ZCD(3) sets out the areas of expertise from which the 4 expert members may be appointed. The areas of expertise are clinical pharmacology, veterinary medicine or pathology, toxicology and occupational health.

Subregulation 42CZD(4) sets out the categories of persons from which up to 7 representative members may be appointed. The categories are diverse and cover consumer representatives through to Australian and New Zealand Government agency representatives.

Subregulation 42ZCD(5) provides that only 1 representative may be appointed from each of the categories mentioned in subregulation (4).

Regulation 42ZCE (Jurisdictional members)

This regulation provides that jurisdictional members are those representatives nominated under subsection 52B(3) of the Act (representing the Commonwealth, States and Territories); as well as each of the New Zealand representatives appointed under paragraph 42ZCD(4) (c) or (d). It is noted that only one of the New Zealand representatives is counted as jurisdictional member for the purposes of regulation 42ZCQ (quorum) and 42ZCR (voting).

Regulation 42ZCF (Appointments in writing)

This regulation provides that any committee members appointed, must be appointed in writing.

Regulation 42ZCG (Appointment of Chair)

This regulation provides that the Minister must appoint a Commonwealth Officer to be the chair of the Committee. It is noted that members that could be Commonwealth officers are persons mentioned in paragraphs 42ZCD (4) (a) and (b) and the representative nominated by the Commonwealth under subsection 52B(3) of the Act.

Regulation 42ZCH (Term of Appointment)

This regulation provides that, subject to the termination provisions set out in regulation 42ZCK, a representative nominated under subsection 52B(3) of the Act is a Committee member for 3 years, or a shorter period stated in their nomination. A member appointed under regulation 42ZCD is appointed for the term stated in their appointment and that must not be more than 3 years (subject to regulation 42ZCK). However, a Committee member may be nominated or appointed for further terms of up to 3 years each. The Chair is appointed for the term stated in the appointment and may be reappointed for further terms.

Regulation 42ZCI (Resignation)

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

Regulation 42ZCJ (Disclosure of interests)

This regulation addresses the situation where a matter is being considered, or is about to be 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, or before, 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 interested member must not be present during any deliberation on, or take part in deciding, this issue.

Regulation 42ZCK (Termination of appointment)

This regulation describes the circumstances under which the Minister may terminate the membership of a Committee member, including a jurisdictional member, under regulation 42ZCD (for example, incompetence, inefficiency, misbehaviour or failing to comply with regulation 42ZCJ). This is a discretionary power. The regulation also describes more serious circumstances under which the Minister must terminate the membership of a member, including a jurisdictional member, (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 membership of the member.

Regulation 42ZCL (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. If the Chair grants leave of absence to a member, the Chair may allow another person, of similar qualifications, experience, and, if appropriate, expertise, to replace the absent member for no more than 2 consecutive meetings.

Regulation 42ZCM (Committee procedures)

This regulation provides that, for the purposes of subsection 52B(2) of the Act, this subdivision sets out the procedures that the Committee must follow in holding meetings.

Regulation 42ZCN (Committee procedures generally)

This regulation sets out explicitly the general procedures that the Committee must follow when carrying out its functions (for example, the Committee must act in accordance with the regulations and with as little formality and as quickly as possible). The regulation also provides that the Committee is not bound by the rules of evidence and may obtain information about an issue in any way that it considers appropriate.

Regulation 42ZCO (Meetings)

Subregulation. 42ZCO(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, as stated in a written

notice to the Committee.

Subregulation 42ZCO(2) provides that if the Chair considers it appropriate and efficient he or she may direct the Committee to meet by videoconference or telephone conference or meet out of session.

Subregulation 42ZCO(3) provides that for this regulation "out of session" means a meeting in which members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting,

Subregulation 42ZCO(4)provides that subject to these regulations, the Committee may decide the procedure for Committee meetings.

Regulation 42ZCP (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 members present must choose a jurisdictional member to preside.

Regulation 42ZCO (Quorum)

This regulation provides that at a Committee meeting, a total of 11 members, which must include 5 jurisdictional members, must be present to form a quorum. For the purposes of this regulation, only one of the representatives appointed under paragraph 42ZCD (4) (c) or (d) may be counted as a jurisdictional member.

Regulation 42ZCR (Voting)

Subregulation 42ZCR(1) provides that a decision made at a Committee meeting by a majority of the votes of the members present and voting is considered to be a decision of the Committee.

Subregulation 42ZCR(2) provides, however, that the majority must include a majority of the

jurisdictional members present and voting for the decision to have effect.

Subregulation 42ZCR(3) provides that if both of the New Zealand representatives appointed under paragraph 42ZCD(4) (c) or (d) are present at the same Committee meeting, then only one of them may vote on a decision as the jurisdictional member.

Subregulation 42ZCR (4) provides that if it is necessary to decide which New Zealand member may vote as the jurisdictional member at a particular meeting, then, for an issue about the regulation of medicines for human use it is the person appointed under paragraph 42ZCD(4) (c), or, in any other case it is the person appointed under paragraph 42ZCD(4) (d), that will vote as the jurisdictional member.

Subregulation 42ZCR(5) provides that the presiding member has a deliberative vote and, in the event of equality of votes of all members present and in the event of equality of votes of jurisdictional members present, also has a casting vote.

Regulation 42ZCS (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.

Regulation 42ZCT (Definitions for Subdivision 5)

This regulation provides that in subdivision 5 "public submission" means a submission to the Committee by a person who is not a member of the Committee; and "scheduling meeting" means a meeting of the Committee for the scheduling of a substance.

Regulation 42ZCU (Public notice of scheduling meetings)

This regulation provides that before a scheduling meeting, the Chair must publish a notice in the Gazette that states the date of the meeting and each substance to be considered for scheduling at the meeting. The notice must also invite public submissions to be made by the closing date mentioned in the notice. The closing date must be at least 4 weeks after the Gazette notice is published and the date of the meeting must be at least a week after the closing date.

Regulation 42ZCV (Consideration of public submissions)

Subregulation 42ZCV(1) provides that all public submissions, made by the closing date, that address a matter mentioned in section 52E of the Act, must be considered by the Committee when they make a decision in relation to the classification or scheduling of a substance.

Subregulation 42ZCV(2) provides that the Committee need not consider a public submission made after the closing date.

Regulation 42ZCW (Other matters to be considered by Committee)

This regulation provides that the Committee must take into account submissions in relation to a substance that are conceived and submitted by a Committee member before or at the meeting that deals with the scheduling of that substance. The regulation also provides that the Committee must take into account any recommendations made by a subcommittee about the substance.

Regulation 42ZCX (Record of reasons for scheduling decisions)

This regulation provides that the Committee must make a record of the reasons for a scheduling decision.

Regulation 42ZCY (Public notice of amendment)

Subregulation 42ZCY(1) provides that a notice under subsection 52D (4) of the Act must include an indication of the amendment, instructions on how to access reasons for the amendment and an invitation to make a further submission to those persons that made a public submission in relation to the subject of the amendment.

Subregulation 42ZCY(2) provides that an amendment must not be stated to come into force earlier than 4 weeks after the publication of the notice.

Subregulation 42ZCY(3) provides that the Committee need not disclose in the notice, or provide access to information that the Committee can properly regard as requiring confidentiality for commercial reasons.

Regulation 42ZCZ (Further public submissions)

This regulation provides that a submission made in response to an invitation mentioned in paragraph 42ZCY(1)(c) must be made within 2 weeks after the notice is published, must address a matter mentioned in section 52E of the Act and must be relevant to the reasons recorded for the amendment. The Committee must consider any submission made and, either confirm the amendment, vary the amendment, or set aside the amendment and replace it with a new scheduling decision. A notice of the new decision must be published under section 52D of the Act.

Regulation 42ZCZA (Public consultation by subcommittee)

This regulation provides that the Committee may assign its public consultation responsibilities and functions set out in Subdivision 5 to a subcommittee. The regulation further provides that the subcommittee must give the Committee a written report setting out how it has complied with those functions and responsibilities.

Regulation 42ZCZB (Urgent scheduling)

This regulation provides that the Committee may make scheduling decisions without following the procedures for public consultation if the Chair of the Committee considers that urgent scheduling of a substance is necessary in the interests of public health and safety. Such a scheduling decision must be reviewed as soon as practicable. The same public consultation procedures that apply to a scheduling meeting will apply to the review.