EXPLANATORY STATEMENT
National Health Reform Act 2011
DIRECTION FROM THE MINISTER FOR HEALTH AND AGEING
TO THE INDEPENDENT HOSPITAL PRICING AUTHORITY UNDER SUBSECTION 226(1) OF THE NATIONAL HEALTH REFORM ACT 2011
- This Instrument is made under subsection 226(1) of the National Health Reform Act 2011 (‘the Act’).
- This Instrument operates by directing the Independent Hospital Pricing Authority (‘the Pricing Authority’) in relation to the performance of its functions and the exercise of its powers.
- Section 131 of the Act sets out the Pricing Authority’s functions. These include determining the national efficient price for health care services provided by public hospitals where the services are funded on an activity basis: s 131(1)(a).
- Specifically, this Instrument directs the Pricing Authority to determine the national efficient price for a list of standard items associated with conducting clinical trials in Australia.
- This work will help to assess the true cost of clinical trial activity and will be an invaluable guide for clinical trial sponsors and public institutions as they plan for future clinical trials.
- Subsection 226(1) of the Act provides that the Minister may give directions to the Pricing Authority in relation to the performance of its functions and the exercise of its powers.
- Subsection 226(2) provides that the Minister must consult with the Standing Council on Health before giving a direction under subsection (1).
- ‘Standing Council on Health’ means the Council described in Section 230 of the Act.
- Subsection 226(3) of the Act, provides that a Direction made under subsection (1) must:
(a) be of a general nature only; and
(b) not be a direction to change:
- a particular national efficient price for health care services provided by public hospitals; or
- a particular efficient cost for health care services provided by public hospitals.
- Under subsection 226(4) of the Act, the Pricing Authority must comply with a Direction made under subsection (1).
- The purpose of this Instrument is to give effect to an agreement of the Standing Council on Health to implement a recommendation of the 2011 Clinical Trials Action Group report: Clinically competitive: boosting the business of clinical trials in Australia.
- This Instrument is of a general nature only and does not direct the Pricing Authority to change a particular national efficient price for health care services provided by public hospitals or a particular efficient cost for health care services provided by public hospitals.
- This Instruments directs the Pricing Authority to, as far as possible, consider the actual activity of a standard clinical trial item and cost-recovery principles in its determination of a national efficient price.
Commencement
14. Pursuant to subsection 12(1)(d) of the Legislative Instruments Act 2003, this Instrument commences the day after the day it is registered.
Consultation
15. Subsection 226(2) of the Act provides that the Minister must consult with the Standing Council on Health before giving a direction under subsection (1).
16. The Minister has previously written to her State and Territory counterparts, outlining her intention to issue a direction under subsection 226(1) of the Act. The Minister also notified the Pricing Authority of her intention to issue a direction under the Act.
17. At the 10 August 2012 meeting of the Standing Council on Health, Ministers endorsed the Minister’s proposal to alter the Pricing Authority’s Work Program.
18. As this Instrument relates solely to the functions and duties of the Pricing Authority, and the activity the Pricing Authority will undertake is not regulatory in nature, this Instrument does not meet the requirements for a Regulation Impact Statement.
Not subject to disallowance
19. Under section 44 of the Legislative Instruments Act 2003, this Instrument is not subject to disallowance.
Statement of Compatibility with Human Rights
20. In accordance with section 9 of the Human Rights (Parliamentary Scrutiny) Act 2011, a statement of compatibility with human rights has not been completed for this Instrument. This is because that section requires a statement of compatibility to be prepared only for a legislative instrument to which section 42 of the Legislative Instruments Act 2003, and the effect of section 44 of that Act is that section 42 does not apply to this Instrument.
Overview
The National Health Reform Act 2011 was enacted to facilitate improvements in the Australian health system, particularly through the establishment of the Independent Hospital Pricing Authority. The Act aimed to address the need for more accurate and consistent pricing of healthcare services, which would contribute to better financial planning and efficiency in the health sector. This legislation was enacted by the Parliament of Australia, reflecting a commitment to reform and enhance the quality and sustainability of healthcare services across the nation. The policy objective of the Act is to ensure that healthcare services are priced in a manner that reflects their true cost, thereby promoting transparency and fairness in the health system. This was intended to support the broader goals of the National Health Reform Agreement, which seeks to improve the overall performance and sustainability of the Australian health system.
Scope and Application
The National Health Reform Act 2011 applies to the Independent Hospital Pricing Authority, which is tasked with determining the national efficient price for health care services provided by public hospitals, particularly where those services are funded on an activity basis. This Act operates under the Commonwealth jurisdiction and extends its reach to all public hospitals within Australia. The Act does not specify particular exclusions or exemptions, but it does clarify that any direction made by the Minister for Health and Ageing must be of a general nature and cannot involve altering specific national efficient prices or efficient costs for hospital services. The Act allows for the Minister to issue directions to the Pricing Authority concerning the performance of its functions and powers, subject to consultation with the Standing Council on Health. This legislative instrument, made under subsection 226(1) of the Act, directs the Pricing Authority to consider actual clinical trial activities and cost-recovery principles when determining the national efficient price for standard clinical trial items. The instrument is not subject to disallowance under the Legislative Instruments Act 2003 and does not require a statement of compatibility with human rights as it does not fall under the purview of the Human Rights (Parliamentary Scrutiny) Act 2011.
Key Provisions
The primary operative sections of the National Health Reform Act 2011, specifically as directed by the Explanatory Statement, focus on the role and functions of the Independent Hospital Pricing Authority (the Pricing Authority). Section 131 of the Act outlines the Pricing Authority's functions, which include determining the national efficient price for healthcare services provided by public hospitals, particularly those funded on an activity basis (s 131(1)(a)). The Explanatory Statement directs the Pricing Authority to determine the national efficient price for a list of standard items associated with conducting clinical trials in Australia (s 131(1)(a)). This determination will aid in assessing the true cost of clinical trial activity, providing valuable insights for clinical trial sponsors and public institutions planning future trials.
The Act imposes obligations on the Pricing Authority to comply with the directions given by the Minister under subsection 226(1), which must be of a general nature and cannot direct a particular change in national efficient price or efficient cost for healthcare services (s 226(3)). The Minister is required to consult with the Standing Council on Health before issuing such a direction (s 226(2)). The Pricing Authority is mandated to consider the actual activity of a standard clinical trial item and cost-recovery principles in determining the national efficient price (s 226(4)). This ensures that the Pricing Authority’s decisions are informed by comprehensive and relevant data.
Any breaches of the obligations set forth in the Act can result in legal consequences. While the Explanatory Statement does not detail specific offences or penalties, it is understood that non-compliance with directions given under subsection 226(1) could lead to legal action against the Pricing Authority for failing to adhere to ministerial directives. However, the maximum penalties for such breaches are not specified within the document. The legislative framework ensures that the Pricing Authority operates within the scope defined by the Act, maintaining the integrity and purpose of the clinical trial pricing determination process.