National Health (Emergency Treatment Program) Revocation Instrument 2012 (No. PB 74 of 2012)

Overview

The National Health (Emergency Treatment Program) Revocation Instrument 2012 (PB 74 of 2012) was enacted to revoke the National Health (Emergency Treatment Program) Special Arrangements Instrument 2010 (PB 41 of 2010). This revocation addresses the need to streamline and update the legislative framework governing the supply of methoxyflurane, ensuring that it aligns with the changes introduced by the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012. This instrument, made under the authority of section 100(2) of the National Health Act 1953, was passed by the relevant legislature to eliminate the redundancy of the previous special arrangement, which no longer served a purpose following the amendments. The overarching policy objective is to ensure that the supply of methoxyflurane continues to be managed effectively under the updated legislative provisions.

Scope and Application

The National Health (Emergency Treatment Program) Revocation Instrument 2012 is a legislative instrument made under the authority of the National Health Act 1953, revoking the National Health (Emergency Treatment Program) Special Arrangements Instrument 2010. This revocation reflects changes made by Schedule 3 of the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012, which effectively transitioned the supply of methoxyflurane from a special arrangement under section 100 of the National Health Act to the Pharmaceutical Benefits Scheme under section 93, effective from 1 October 2012. This instrument applies nationally and pertains to the supply of methoxyflurane, addressing the need for the special arrangement that was previously established. There are no specific exclusions, exemptions, or thresholds mentioned in the instrument, which is of a minor and machinery nature. The revocation signifies that the special arrangement was no longer necessary following legislative amendments that streamlined the availability of methoxyflurane through the PBS.

Key Provisions

The National Health (Emergency Treatment Program) Revocation Instrument 2012 (PB 74 of 2012) revokes the earlier National Health (Emergency Treatment Program) Special Arrangements Instrument 2010 (PB 41 of 2010). This revocation was enacted under section 100(2) of the National Health Act 1953 (the Act). The primary purpose of this revocation is to address the redundancy of the special arrangement concerning the supply of methoxyflurane, as the recent amendments in the National Health Amendment (Pharmaceutical Benefits Scheme) Act 2012 (the Amending Act) now provide for the drug under section 93 of the Act. Therefore, the special arrangement under section 100 of the Act is no longer necessary. Entities and individuals governed by the Act now face a shift in how methoxyflurane is to be supplied. The obligations previously outlined in the special arrangement are now superseded by the provisions under section 93, which became effective from 1 October 2012. This change requires those involved in the prescription, distribution, and use of methoxyflurane to comply with the new regulatory framework established by section 93 of the Act. This includes ensuring that the drug is supplied through prescriber bags only, as stipulated by Schedule 3 of the Amending Act. Failure to comply with the new requirements outlined in the Act and the subsequent revocation instrument could result in civil or criminal consequences. While specific penalties are not detailed in the revocation instrument itself, breaches of the National Health Act 1953 can typically lead to substantial fines and, in severe cases, imprisonment. The exact penalties would depend on the nature and severity of the breach, as well as the specific provisions of the Act being contravened. This legislative instrument also engages with human rights considerations, particularly Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). By facilitating the availability of methoxyflurane under section 93 of the Act, the instrument supports the progressive realisation of the right to the highest attainable standard of physical and mental health. The involvement of the Pharmaceutical Benefits Advisory Committee (PBAC) in recommending access to medicines ensures that decisions are evidence-based, thereby advancing human rights through a structured and rational process.