EXPLANATORY STATEMENT
Select Legislative Instrument 2009 No. 194
National Health Act 1953
National Health Amendment Regulations 2009 (No. 1)
Section 140 of the National Health Act 1953 (the Act) provides, in part, that the
Governor-General may make regulations, not inconsistent with the Act, prescribing all matters which 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, for prescribing the fees and allowances payable to members of a committee established under the Act, other than members who are officers of the Public Service of the Commonwealth Government or of a state Government.
The Pharmaceutical Benefits Advisory Committee (PBAC) is established under section 100A of the Act. Its primary role is to make recommendations and give advice to the Minister for Health and Ageing in relation to drugs and medicinal preparations seeking to be subsidised under the Pharmaceutical Benefits Scheme (PBS), and about drugs already listed on the PBS.
Section 101A of the Act provides that PBAC may establish sub-committees to assist it in performing its functions. The Drug Utilisation Sub-Committee (DUSC) and Economics Sub-Committee (ESC) are sub-committees of the PBAC which are established in accordance with section 101A of the Act. DUSC and ESC undertake evaluation and analysis work to support PBAC’s deliberations. Subsection 101A(4) provides that sub-committees established under that section (i.e. DUSC and ESC) are ‘committees’ for the purposes of section 140.
The purpose of the Regulations is to amend regulation 39 of the National Health Regulations 1954 (the Principal Regulations) to exclude ESC and DUSC from the definition of ‘committee’ and thereby from the operation of regulations 40 and 41 of the Principal Regulations. Regulations 40 and 41 set out the fees and allowances payable to the members of committees established under the Act, including ESC and DUSC. The fees and allowances payable to members of ESC and DUSC are set out in the National Health (Pharmaceutical Benefits) Amendment Regulations 2009 (No. 1).
Consultation was undertaken with the Remuneration Tribunal in relation to the remuneration of ESC and DUSC. The Remuneration Tribunal felt that DUSC and ESC should be paid in accordance with regulations made under section 140 of the Act. Consultation with DUSC and ESC was not considered necessary given that there is no substantive change to the members’ entitlements.
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.
The Regulations commence on 31 July 2009.
Overview
The National Health Amendment Regulations 2009 (No. 1) were introduced to address a specific gap in the remuneration framework for the Economics Sub-Committee (ESC) and the Drug Utilisation Sub-Committee (DUSC) under the National Health Act 1953. Enacted by the Governor-General, these Regulations aim to amend the National Health Regulations 1954 to exclude ESC and DUSC from the definition of 'committee'. This exclusion removes these sub-committees from the application of regulations 40 and 41, which govern the fees and allowances for committee members. Instead, the remuneration for ESC and DUSC members is now set out in the National Health (Pharmaceutical Benefits) Amendment Regulations 2009 (No. 1). This legislative adjustment follows consultations with the Remuneration Tribunal, which advised that the remuneration for these sub-committees should align with the regulations made under section 140 of the Act.
Scope and Application
The National Health Amendment Regulations 2009 (No. 1) amends the National Health Regulations 1954, impacting the remuneration framework for the Economics Sub-Committee (ESC) and the Drug Utilisation Sub-Committee (DUSC) established under the National Health Act 1953. These sub-committees, formed to assist the Pharmaceutical Benefits Advisory Committee (PBAC) in their advisory role on the Pharmaceutical Benefits Scheme (PBS), are excluded from the definition of ‘committee’ under the amended regulations, thus altering their eligibility for the fees and allowances specified in regulations 40 and 41 of the Principal Regulations. This change aligns the remuneration of ESC and DUSC with the broader regulatory framework under section 140 of the Act, as determined through consultation with the Remuneration Tribunal. The application of these regulations is confined to the Commonwealth, and they apply specifically to the members of ESC and DUSC, ensuring that their allowances are set according to the criteria established under section 140 of the Act, while exempting them from the general provisions affecting other committees under the Act. The Regulations commenced on 31 July 2009, formalising the distinct remuneration structure for these specialised sub-committees.
Key Provisions
The main operative sections of the National Health Amendment Regulations 2009 (No. 1) are those that amend the definition of ‘committee’ in the National Health Regulations 1954. Specifically, regulation 39 of the Principal Regulations is amended to exclude the Economics Sub-Committee (ESC) and the Drug Utilisation Sub-Committee (DUSC) from the definition of ‘committee’. This exclusion means that ESC and DUSC are no longer subject to the provisions of regulations 40 and 41 of the Principal Regulations, which pertain to fees and allowances payable to committee members. The fees and allowances for ESC and DUSC members are instead specified in the National Health (Pharmaceutical Benefits) Amendment Regulations 2009 (No. 1).
The Regulations impose obligations on the parties involved by ensuring that the ESC and DUSC, while remaining committees under the National Health Act 1953, are excluded from the application of specific provisions in the Principal Regulations that govern the payment of fees and allowances to committee members. The exclusion is intended to streamline the process of determining appropriate remuneration for these sub-committees, aligning it with broader regulatory frameworks as recommended by the Remuneration Tribunal. This exclusion does not affect the substantive entitlements of ESC and DUSC members but rather clarifies the regulatory framework governing their remuneration.
Failure to comply with the Regulations may lead to civil or administrative consequences, as the Regulations are designed to ensure that the correct remuneration framework applies to the ESC and DUSC. While the explanatory statement does not explicitly state the penalties for non-compliance, it is reasonable to infer that any deviation from the prescribed remuneration arrangements could result in disputes over the correct fees and allowances. The precise nature of the penalties would depend on the specific provisions of the National Health Act 1953 and any related administrative processes. However, the key consequence of non-compliance would be the potential for ESC and DUSC members to be underpaid or overpaid, leading to administrative corrections and possible disputes.