EXPLANATORY STATEMENT
STATUTORY RULES 1984 NO. 158
THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
Issued by the authority of the Minister for Health
Section 30 of the Therapeutic Goods Act 1966 (‘the Act’) provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which by the Act are required or permitted to be prescribed, or which are necessary or convenient to be prescribed for carrying out or giving effect to the Act, and in particular, inter alia, for making provisions for or in relation to the establishment of committees to advise the Minister on matters relating to the importation into Australia of therapeutic substances and on such other matters as are prescribed, and the functions and powers of those committees.
Regulation 17 of the Therapeutic Goods Regulations (‘the Regulations’) establishes the Therapeutic Goods Advisory Committee and prescribes its functions and membership. The functions of the Committee are to consider:
• any matter (except any matter relating to substances classified as dangerous under section 29 of the Act) referred to it by the Minister relating to the administration of the Act; and
• the standards applicable to any goods for therapeutic use, and the requirements with respect to labelling and packaging applicable to any such goods, insofar as those standards or requirements relate to the manufacture, distribution or use of goods for therapeutic use,
and to advise the Minister in relation to that matter or those standards.
The membership of the Committee has been extended to allow for a number of additional organizations to be represented.
Regulation 1 amended existing regulation 17 to provide for persons appointed by the Minister for Health on the nomination of the following organizations to be represented on the Committee:
• Agricultural and Veterinary Chemicals Association of Australia;
• The Australian Medical Devices and
Diagnostics Association;
• Australian Physiotherapy Association;
• Australian Resuscitation Council; and
• The Institution of Biomedical Engineering (Australia) Incorporated.
The Regulations also provide for representation on the Committee of two persons appointed by the Minister for Health on the nomination of the National Council of Chemical and Pharmaceutical Industries instead of three persons as was formerly prescribed. The amendment was required because an organization previously represented on the National Council of Chemical and Pharmaceutical Industries, the Agricultural and Veterinary Chemicals Association of Australia, now seeks representation in its own right.
Regulation 1 also made a minor drafting change to existing sub-regulation 17(5), in consequence of the changes to the membership.
Regulation 2 amended existing sub-regulation 23(2) which provides for the numbers of members that constitute a quorum at meetings of the various committees established under the Regulations.
Sub-regulation 23(2) was omitted and a new sub-regulation 23(2) substituted which provides that at the meeting of a Committee:
• in the case of the Therapeutic Goods Advisory Committee, 7 members constitutes a quorum;
• in the case of the Therapeutic Goods Standards Committee, 5 members constitutes a quorum; and
• in the case of the Australian Drug Evaluation Committee, if less than 7 members of the committee are in Australia when a meeting is held - 3 members constitutes a quorum, or in any other case - 4 members constitutes a quorum.
Overview
The Therapeutic Goods Regulations (Amendment) Statutory Rules 1984 No. 158 were enacted to address the need for broader representation on the Therapeutic Goods Advisory Committee, enhancing its capacity to provide comprehensive advice on therapeutic goods matters. This amendment was introduced in response to the evolving landscape of therapeutic goods and the necessity for diverse expertise to ensure effective regulation. The Regulations were issued under the authority of the Minister for Health and were designed to align with the objectives of the Therapeutic Goods Act 1966 by ensuring that the Advisory Committee reflects a wider array of professional and industry perspectives. The policy objective was to improve the regulatory framework by incorporating additional voices from relevant sectors, thereby fostering a more inclusive and informed decision-making process regarding therapeutic goods in Australia.
Scope and Application
The Therapeutic Goods Regulations (Amendment) Statutory Rules 1984 No. 158, issued under section 30 of the Therapeutic Goods Act 1966, pertain to the Therapeutic Goods Advisory Committee established by regulation 17 of the Therapeutic Goods Regulations. These amendments extend the membership of the Committee to include representatives from the Agricultural and Veterinary Chemicals Association of Australia, the Australian Medical Devices and Diagnostics Association, the Australian Physiotherapy Association, the Australian Resuscitation Council, and the Institution of Biomedical Engineering (Australia) Incorporated. The amendment reduces the representation of the National Council of Chemical and Pharmaceutical Industries from three to two members due to the Agricultural and Veterinary Chemicals Association of Australia now having its own representation. Additionally, the Regulations specify the quorum requirements for meetings of the Therapeutic Goods Advisory Committee, the Therapeutic Goods Standards Committee, and the Australian Drug Evaluation Committee. These changes are necessary to ensure that the Committee remains representative of the various sectors involved in the administration of the Therapeutic Goods Act and to maintain effective quorums for decision-making processes.
Key Provisions
The main operative sections of the Therapeutic Goods Regulations (Amendment) (Statutory Rules 1984 No. 158) pertain to the establishment and composition of the Therapeutic Goods Advisory Committee (Regulation 1). Regulation 1 amends the existing regulation 17 to extend the Committee's membership to include representatives from additional organizations, specifically the Agricultural and Veterinary Chemicals Association of Australia, the Australian Medical Devices and Diagnostics Association, the Australian Physiotherapy Association, the Australian Resuscitation Council, and the Institution of Biomedical Engineering (Australia) Incorporated. The amendment also adjusts the representation of the National Council of Chemical and Pharmaceutical Industries from three to two persons, to accommodate the Agricultural and Veterinary Chemicals Association of Australia's new direct representation. A minor drafting change was also made to sub-regulation 17(5) to reflect these membership changes. Regulation 2 modifies sub-regulation 23(2) to specify the quorum requirements for various committees, establishing that 7 members constitute a quorum for the Therapeutic Goods Advisory Committee, 5 members for the Therapeutic Goods Standards Committee, and either 3 or 4 members, depending on the number of members present in Australia, for the Australian Drug Evaluation Committee.
The obligations and requirements imposed by these regulations on the parties involved primarily relate to the composition and functioning of the Therapeutic Goods Advisory Committee. The amended membership must now include representatives from the newly listed organizations, and the quorum requirements have been updated to ensure effective decision-making and functionality within the committee meetings. The Minister for Health has the responsibility of appointing these representatives on the nomination of the respective organizations. These amendments ensure that the committee has a broader range of expertise and perspectives to consider when advising the Minister on therapeutic goods matters.
The Therapeutic Goods Regulations (Amendment) does not explicitly state any new offences, penalties, or civil/criminal consequences for breach. However, the importance of adhering to the regulations lies in the effective administration and oversight of therapeutic goods in Australia. Non-compliance with the requirements for committee membership and quorum could potentially impact the quality and comprehensiveness of the advice provided to the Minister, thereby affecting regulatory decisions and public health outcomes. While specific penalties are not detailed in these regulations, any significant failure to comply with the Act or Regulations could result in broader administrative or legal consequences under the Therapeutic Goods Act 1966.