EXPLANATORY STATEMENT
Select Legislative Instrument 2010 No. 327
National Health Act 1953
National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 6)
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 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. In particular, includes 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 or of a state.
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 Economic 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 section 101A (i.e. DUSC and ESC) are “committees” for the purposes of section 140.
Regulation 48 of the National Health (Pharmaceutical Benefits) Regulations 1960 (the Principal Regulations) sets the fees and allowances payable to the chair and members of DUSC and ESC as the amounts that are payable to the chair and members of professional committees under Schedule B to the Remuneration Tribunal Determination 2009/14: Remuneration and Allowances for Holders of Part-Time Public Office.
The purpose of the Regulations is to update the title of the Remuneration Tribunal Determination in the Principal Regulations to reflect a more recent determination. The Regulations ensure payment of PBAC sub-committee members, and DUSC and ESC, is consistent with the Remuneration Tribunal Determination 2010/11: Remuneration and Allowances for Holders of Part-Time Public Office .
The Act specifies no conditions that need to be satisfied 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 the day after they are registered on the Federal Register of Legislative Instruments.
Consultation has been undertaken with the Remuneration Tribunal, who felt that DUSC and ESC should be paid in accordance with regulations made under section 140 of the National Health Act 1953. Consultation with DUSC and ESC was not considered necessary given that there is no substantive change of the members' entitlements.
Overview
The National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 6) were enacted to update the remuneration for members of the Drug Utilisation Sub-Committee (DUSC) and Economic Sub-Committee (ESC) of the Pharmaceutical Benefits Advisory Committee (PBAC) established under the National Health Act 1953. These regulations ensure that the fees and allowances for these committee members are consistent with the latest Remuneration Tribunal Determination, specifically the Remuneration and Allowances for Holders of Part-Time Public Office 2010/11. This legislative instrument was created under section 140 of the National Health Act, which empowers the Governor-General to make regulations necessary for the implementation and enforcement of the Act. There were no specific conditions outlined in the Act that needed to be met before these regulations could be enacted. These Regulations are considered a legislative instrument under the Legislative Instruments Act 2003 and took effect on the day following their registration on the Federal Register of Legislative Instruments. The Remuneration Tribunal was consulted, and they concurred that the amendments were appropriate.
Scope and Application
The National Health (Pharmaceutical Benefits) Amendment Regulations 2010 apply to members of the Pharmaceutical Benefits Advisory Committee (PBAC) and its sub-committees, specifically the Drug Utilisation Sub-Committee (DUSC) and Economic Sub-Committee (ESC), as established under the National Health Act 1953. These regulations govern the fees and allowances payable to the chair and members of these committees, excluding those who are officers of the Public Service of the Commonwealth or of a state. The purpose of these regulations is to update the reference to the Remuneration Tribunal Determination in the Principal Regulations to align with the more recent Remuneration Tribunal Determination 2010/11. By doing so, the regulations ensure that the payment to members of DUSC and ESC is consistent with the latest determination. There are no specific exclusions, exemptions, or thresholds mentioned in the text, and the scope of the Act applies nationally across Australia as it is a Commonwealth legislation. The Act allows for the creation of subordinate instruments to extend or restrict the application of the regulations, as necessary.
Key Provisions
The main operative sections of the National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 6) concern the updating of the title of the Remuneration Tribunal Determination within the Principal Regulations (reg. 48) to align with the more recent Remuneration Tribunal Determination 2010/11. These regulations ensure that the payment to the members of the Pharmaceutical Benefits Advisory Committee (PBAC) sub-committees, specifically the Drug Utilisation Sub-Committee (DUSC) and the Economic Sub-Committee (ESC), adheres to the updated Remuneration and Allowances for Holders of Part-Time Public Office. The regulations are a legislative instrument under the Legislative Instruments Act 2003, and they commence on the day following their registration on the Federal Register of Legislative Instruments.
These regulations impose obligations on the relevant authorities to ensure that the members of DUSC and ESC are remunerated in accordance with the Remuneration Tribunal Determination 2010/11. They specifically address the payment of fees and allowances to the chair and members of these sub-committees, ensuring that this is consistent with the amounts payable to the chair and members of professional committees under the updated Remuneration Tribunal Determination. The regulations mandate that the updated title of the determination must be reflected in the Principal Regulations, thereby formalising the payment structure for these committee members.
Breaches of these regulations could lead to non-compliance with the remuneration standards set by the Remuneration Tribunal, potentially resulting in disputes or claims for underpayment. However, the Explanatory Statement does not detail specific offences, penalties, or civil/criminal consequences for non-compliance with these regulations. The primary consequence would likely be financial, affecting the proper remuneration of DUSC and ESC members, and potentially leading to administrative or legal challenges if members feel they are not being paid appropriately. The regulations do not explicitly state maximum penalties for breaches, but such issues would likely be resolved through administrative or judicial processes as per the relevant legislation and tribunal rulings.