EXPLANATORY STATEMENT
Select Legislative Instrument 2010 No. 115
National Health Act 1953
National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 2)
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 2008/07: 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 2009/14: Remuneration and Allowances for Holders of Part-Time Public Office .
As the conditions of payment will not change following the amendment, and the payments to the chair and members of the respective committees will increase marginally under the 2009/14, consultation with members of the ESC and DUSC was not necessary. Payments under the 2008/07 Determination were: Chair - $789 per day; Member - $597 per day. Under the 2009/14 Determination, the payments are: Chair - $813 per day; Member - $615 per day.
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.
Overview
The National Health Act 1953, enacted by the Parliament of Australia, addresses the need for a structured framework governing health services, including the regulation of pharmaceutical benefits. The Act establishes the Pharmaceutical Benefits Advisory Committee (PBAC) to advise on drugs and medicinal preparations for subsidy under the Pharmaceutical Benefits Scheme (PBS). To support the PBAC, the Act allows for the establishment of sub-committees, such as the Drug Utilisation Sub-Committee (DUSC) and Economic Sub-Committee (ESC), which perform evaluation and analysis work. The National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 2) were introduced to update the fees and allowances payable to the chair and members of these sub-committees, aligning them with the most recent Remuneration Tribunal Determination 2009/14. This legislative update ensures that the payments to committee members remain consistent with the latest remuneration standards set by the Remuneration Tribunal, without necessitating additional consultation due to the marginal nature of the increase in payments.
Scope and Application
The National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 2) apply to the members of the Pharmaceutical Benefits Advisory Committee (PBAC) and its sub-committees, including the Drug Utilisation Sub-Committee (DUSC) and the Economic Sub-Committee (ESC), which are established under the National Health Act 1953. These Regulations prescribe the fees and allowances payable to the chairs and members of DUSC and ESC, who are not officers of the Public Service of the Commonwealth or of a state. The application of these Regulations is confined to ensuring that the remuneration for these committee members aligns with the Remuneration Tribunal Determination 2009/14: Remuneration and Allowances for Holders of Part-Time Public Office. The Regulations have a national jurisdictional reach as they are made under the authority of the Commonwealth of Australia. There are no exclusions or exemptions specified in the text, and the conditions for their application are straightforward, being tied directly to the remuneration framework established by the Remuneration Tribunal. The Regulations do not extend or restrict the application of the Act through subordinate instruments beyond the scope of updating the title of the Remuneration Tribunal Determination in the Principal Regulations.
Key Provisions
The main operative sections of the National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 2) concern the fees and allowances payable to the chair and members of the Drug Utilisation Sub-Committee (DUSC) and the Economic Sub-Committee (ESC) of the Pharmaceutical Benefits Advisory Committee (PBAC) (reg 48). These sections are based on the Remuneration Tribunal Determination 2009/14: Remuneration and Allowances for Holders of Part-Time Public Office, and update the title of the Remuneration Tribunal Determination in the Principal Regulations to reflect this more recent determination. The purpose of these Regulations is to ensure that the payment of members of DUSC and ESC is consistent with the 2009/14 Determination, which provides for a slight increase in daily rates over the previous 2008/07 Determination.
The Regulations impose specific obligations on the parties and entities they govern, primarily concerning the payment of fees and allowances to the chair and members of DUSC and ESC. These obligations require that payments be made in accordance with the Remuneration Tribunal Determination 2009/14, which sets out the rates for part-time public office holders. The Regulations ensure that the PBAC sub-committees, DUSC and ESC, are compensated appropriately for their roles in supporting the PBAC’s deliberations on the Pharmaceutical Benefits Scheme (PBS).
The Regulations do not explicitly outline specific offences, penalties, or consequences for breaches. However, by establishing the fees and allowances under the Remuneration Tribunal Determination 2009/14, any failure to adhere to these specified rates could be considered a breach of the Regulations. While the exact penalties for non-compliance are not detailed within the text, any breach of the National Health (Pharmaceutical Benefits) Amendment Regulations 2010 (No. 2) may lead to legal consequences as per the general legislative framework governing the enforcement of regulations. The penalties for non-compliance with regulations can vary and typically include fines, legal action, or other corrective measures to ensure adherence to the prescribed standards.