EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health Special Arrangement Revocation Instrument 2012
PB 23 of 2012
Authority
This legislative instrument is made pursuant to subsection 100(2) of the National Health Act 1953 (the Act), which provides that the Minister may vary or revoke a special arrangement for the supply of pharmaceutical benefits made under subsection 100(1) of the Act.
Purpose
This legislative instrument revokes the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011 (PB 87 of 2011) (CPAP) and the National Health (Trastuzumab) Special Arrangement 2011 (PB 94 of 2011) (Trastuzumab). CPAP and Trastuzumab are both special arrangements for the supply of pharmaceutical benefits that were made under subsection 100(1) of the Act.
The National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (EFC) is the new special arrangement, made under subsection 100(1) of the Act, that deals with the supply of chemotherapy medicines, including pharmaceutical benefits available under CPAP and Trastuzumab. EFC commenced on 1 December 2011. It was intended that all suppliers (including public hospital authorities) would commence supplying chemotherapy medicines under EFC from
1 December 2011 and that CPAP and Trastuzumab would be revoked on that day.
However, software delays meant that some public hospitals were unable to transition to EFC on 1 December 2011. Accordingly, CPAP and Trastuzumab remained in force for supplies of chemotherapy medicines by approved public hospital authorities as an interim measure to enable public hospitals further time to transition to the new chemotherapy arrangements.
This interim measure concludes on 31 March 2012. From 1 April 2012 chemotherapy medicines will no longer be able to be supplied by public hospitals under CPAP or Trastuzumab, as, on that date, both special arrangements will be revoked by this instrument.
Consultation
Key stakeholder groups representing oncologists and pharmacists, State and Territory health departments, the Department of Human Services and the Medical Software Industry Association were consulted throughout the process of developing all legislative instruments under the Act necessary to implement the section 100 special arrangement for the Efficient Funding of Chemotherapy. This included the revocation of the previous special arrangements for the supply of chemotherapy medicines.
This instrument commences on 1 April 2012.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Overview
The National Health Special Arrangement Revocation Instrument 2012 was enacted in 2012 under the authority of the National Health Act 1953, which is administered by the Australian Parliament. This legislative instrument revokes two previous special arrangements, the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011 and the National Health (Trastuzumab) Special Arrangement 2011, both of which were made to facilitate the supply of pharmaceutical benefits. The purpose of this instrument is to replace these arrangements with the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, which commenced on 1 December 2011. The revocation of the previous arrangements was delayed due to software issues affecting some public hospitals, allowing them additional time to transition to the new arrangements. The National Health Special Arrangement Revocation Instrument 2012 concludes this interim period, revoking the earlier arrangements on 31 March 2012 and establishing the new arrangement as the sole means for supplying chemotherapy medicines from 1 April 2012. The development of these legislative instruments involved consultation with key stakeholders, including oncologists, pharmacists, state and territory health departments, and the Department of Human Services.
Scope and Application
The National Health Special Arrangement Revocation Instrument 2012 applies to the revocation of two specific special arrangements for the supply of pharmaceutical benefits: the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011 and the National Health (Trastuzumab) Special Arrangement 2011. This legislative instrument is made under subsection 100(2) of the National Health Act 1953, which empowers the Minister to vary or revoke special arrangements for the supply of pharmaceutical benefits. The revocation is necessitated by the implementation of a new special arrangement, the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011, which was designed to streamline the supply of chemotherapy medicines and commenced on 1 December 2011. However, due to software delays, an interim measure was put in place to allow public hospitals additional time to transition to the new arrangements, with the result that the two revoked special arrangements remained in force until 31 March 2012. This instrument, which revokes the aforementioned special arrangements, applies across the Commonwealth of Australia and is effective from 1 April 2012.
Key Provisions
The National Health Special Arrangement Revocation Instrument 2012 (F2012L00725) revokes two previous special arrangements for the supply of pharmaceutical benefits: the National Health (Chemotherapy Pharmaceuticals Access Program) Special Arrangement 2011 (PB 87 of 2011) and the National Health (Trastuzumab) Special Arrangement 2011 (PB 94 of 2011). These revocations are made pursuant to subsection 100(2) of the National Health Act 1953 (the Act) (section 2). These special arrangements, referred to as CPAP and Trastuzumab, have been replaced by the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (EFC), which commenced on 1 December 2011 and is still in effect (section 3). Due to software delays, the transition to EFC by public hospitals was not fully operational by 1 December 2011, leading to an interim measure where CPAP and Trastuzumab continued to apply until 31 March 2012 (section 4). This legislative instrument revokes CPAP and Trastuzumab from 1 April 2012.
The Act imposes specific obligations and requirements on entities governed by these special arrangements. These include ensuring that the supply of chemotherapy medicines by public hospitals adheres to the terms and conditions set out in EFC from 1 April 2012. Public hospitals and other suppliers must transition their systems and processes to comply with the new arrangements by the specified date. The Act also requires consultation with relevant stakeholders, including oncologists, pharmacists, state and territory health departments, the Department of Human Services, and the Medical Software Industry Association, as evidenced by the consultations undertaken during the development of the legislative instruments necessary to implement EFC (section 5).
The Act does not explicitly state offences, penalties, or civil/criminal consequences for breach of the special arrangements or the revocation instrument itself. However, non-compliance with the National Health Act 1953 or its regulations could potentially lead to legal consequences. In general, breaches of health-related legislation may result in civil penalties, fines, or other legal actions under the relevant laws. For precise details on penalties, one would need to refer to the broader provisions of the National Health Act 1953 and associated regulations. The revocation instrument itself is effective from 1 April 2012, ensuring a clear transition period and compliance deadline for all parties involved.