National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2015 (PB 34 of 2015)

Overview

The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2015 was enacted to address a gap in the National Health (Growth Hormone Program) Special Arrangement 2011. The instrument amends the special arrangement to exclude medication chart prescriptions, which is consequential to changes in the National Health (Pharmaceutical Benefits) Regulations 1960. This legislative instrument, made under the authority of the National Health Act 1953, ensures that the Special Arrangement does not apply to hospital medication chart prescriptions, thereby supporting the testing and implementation of the Pharmaceutical Benefits Scheme (PBS) hospital medication chart prescription. The instrument, which commenced on 1 April 2015, was developed following extensive consultations with key health stakeholders and aims to balance the progressive realisation of the highest attainable standard of physical and mental health with efficient implementation strategies.

Scope and Application

The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2015 applies to the National Health (Growth Hormone Program) Special Arrangement 2011, which is a part of the National Health Act 1953. This legislation primarily affects entities involved in the supply and prescription of pharmaceutical benefits under the Act, particularly relating to growth hormone medications. The amendment excludes medication chart prescriptions from the Special Arrangement, aligning with recent changes to the National Health (Pharmaceutical Benefits) Regulations 1960. This legislative instrument operates on a national level, impacting the entire Commonwealth of Australia. The amendment reflects the transitional arrangements for hospital medication chart prescriptions under the Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS (RPBS), supporting trial access and providing additional time for stakeholders to consider the implications of such prescriptions within the Special Arrangement. The instrument is effective from 1 April 2015, and its compatibility with human rights has been affirmed, recognising the right to the highest attainable standard of physical and mental health.

Key Provisions

The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2015 (F2015L00444) amends the National Health (Growth Hormone Program) Special Arrangement 2011 (PB 88 of 2011) by excluding medication chart prescriptions from the scope of the special arrangement (section 3(1)). This amendment is a direct consequence of changes to the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations), which were updated by the National Health (Pharmaceutical Benefits) Amendment (Medication Chart Prescriptions) Regulation 2015 on 1 April 2015 (section 3(2)). The Regulations introduce a transitional period for hospital medication chart prescriptions, allowing for trial access and additional time to evaluate the use of these prescriptions within the Pharmaceutical Benefits Scheme (PBS) and Repatriation PBS (RPBS) (section 3(3)). The Act imposes specific obligations on parties involved in the administration and implementation of the Special Arrangement. It requires that any amendments to the Special Arrangement must be consistent with changes to the Regulations and that these amendments support the progressive implementation of medication chart prescriptions within the PBS and RPBS frameworks (section 100(1)). The Minister retains the authority to vary or revoke the special arrangement as necessary, ensuring flexibility in the implementation process (section 100(2)). The amendment also necessitates that stakeholders, including hospitals, pharmacists, and prescribers, adhere to the transitional provisions set out in the Regulations when dealing with medication chart prescriptions. Breach of the provisions of this legislative instrument may lead to various consequences. For instance, failure to comply with the transitional period for medication chart prescriptions or any other stipulated requirements could result in administrative penalties or legal action. The National Health (Pharmaceutical Benefits) Amendment (Medication Chart Prescriptions) Regulation 2015 provides for specific penalties for non-compliance with the Regulations, which may include fines or other administrative sanctions. Additionally, any actions that contravene the Act or the Regulations could potentially lead to civil or criminal proceedings, depending on the severity and intent of the breach. This legislative instrument is compatible with human rights, as it supports the progressive realisation of the right to the highest attainable standard of physical and mental health, as recognised in the International Covenant on Economic, Social and Cultural Rights (ICESCR). By providing for subsidised access to medicines and a staged implementation of hospital medication chart prescriptions, the Act and its amendments aim to balance efficiency with careful consideration of stakeholder readiness and human rights implications. The instrument's alignment with human rights is further affirmed by the Department of Health's extensive consultation process with key health stakeholders, which demonstrated strong support for the trial and amendments required to facilitate the measure.