EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 4)
PB 77 of 2013
Authority
This legislative instrument is made pursuant to subsection 84AG(1) of the National Health Act 1953 (the Act), which gives the Minister the power to determine a therapeutic group and that two or more listed drugs are in the same therapeutic group.
Purpose
This legislative instrument amends the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 (PB 1 of 2010) (the Principal Determination), which determines a number of therapeutic groups and the listed drugs that are in those therapeutic groups.
The purpose of this amending instrument, which is required by subsection 84AG(4) of the Act, is to remove from its therapeutic group, each listed drug which has at least one listed brand to which section 99ADH will apply on 1 December 2013. Section 99ADH deals with price disclosure price reductions. This amending determination is effective 1 December 2013.
This instrument amends Parts 7 and 8 of Schedule 1 to the Principle Determination. Part 7 sets out the Statins HP group (the HMG Co-A reductase inhibitor higher potency group). This instrument removes the listed drug ‘Atorvastatin’ from this group. Part 8 sets out the Venlafaxine group (the Venlafaxine and Venlafaxine derivative antidepressants group). This instrument removes the listed drug
‘Venlafaxine’ from this group.
Variation and revocation
Unless there is an express power to revoke or vary PB 1 of 2010 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 1 of 2010.
Consultation
This instrument is consequential to price disclosure price reductions, is minor and machinery in nature and does not require any additional consultation.
This instrument commences on 1 December 2013.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2012 (No. 2) (PB XX of 2012)
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
This Legislative Instrument is made pursuant to subsection 84AG(1) of the National Health Act 1953 (the Act), which relates to therapeutic groups. This instrument amends the principle instrument which determines a number of therapeutic groups and the listed drugs that are in those therapeutic groups.
Human rights implications
This legislative instrument engages Article 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based..
Conclusion
This Legislative Instrument is compatible with human rights as it does not raise any human rights issues.
Adriana Platona
Assistant Secretary, Pharmaceutical Evaluation Branch
Pharmaceutical Benefits Division, Department of Health and Ageing
Overview
The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 4) was enacted to amend the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010. This amendment was necessitated by the introduction of new provisions under section 99ADH of the National Health Act 1953, which pertains to price disclosure and price reductions for certain listed drugs. This determination, made by the Minister under the authority granted by the Act, specifically aims to remove drugs that will be subject to the new pricing regulations from their respective therapeutic groups, effective from 1 December 2013. This adjustment ensures that the therapeutic groupings within the Pharmaceutical Benefits Scheme remain aligned with current legislative requirements, thereby maintaining the integrity and efficacy of the scheme.
This legislative instrument was made by the Minister for Health under the authority provided by the National Health Act 1953. The policy objective of this amendment is to ensure that the Pharmaceutical Benefits Scheme continues to operate effectively by keeping the therapeutic groupings updated with any legislative changes. The instrument does not require additional consultation as it is minor and consequential to the new pricing regulations. It is compatible with human rights as it supports the progressive realisation of the right to health by ensuring access to medicines through an evidence-based benefits scheme.
Scope and Application
The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 4) amends the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010, which is made under the National Health Act 1953. The amendment involves the removal of specific listed drugs from their respective therapeutic groups, effective from 1 December 2013. This change is consequential to the application of section 99ADH of the Act, which deals with price disclosure and price reductions. The Act applies to the listed drugs within the therapeutic groups, impacting the pharmaceutical industry and the entities that manufacture, supply, or prescribe these medications. The geographic reach of the Act is national, as it pertains to the Pharmaceutical Benefits Scheme (PBS), which is a Commonwealth initiative. The amendment does not introduce any new exclusions, exemptions, or thresholds; rather, it refines the existing framework by reclassifying certain drugs. The Act’s application may be further extended or restricted through additional subordinate instruments, although none are specified in this amendment.
Key Provisions
The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 4) amends the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 (PB 1 of 2010). The main changes made by the 2013 amendment concern the removal of specific drugs from their designated therapeutic groups. Specifically, under the 2010 Determination, Atorvastatin was classified in the Statins HP group (Part 7), and Venlafaxine was classified in the Venlafaxine group (Part 8). The 2013 Amendment removes these drugs from their respective groups. The changes are effective from 1 December 2013 (subsection 84AG(4) of the National Health Act 1953).
The 2013 Amendment introduces obligations for drug manufacturers and the Pharmaceutical Benefits Advisory Committee (PBAC). Drug manufacturers must now ensure that their listed drugs are correctly classified in the appropriate therapeutic groups as per the amended Determination. The PBAC, in its role of recommending the inclusion of drugs on the Pharmaceutical Benefits Scheme (PBS), must take into account the revised therapeutic classifications when making recommendations. This ensures that decisions about which drugs are subsidised are based on accurate and up-to-date therapeutic group information.
The determination itself does not directly impose criminal or civil penalties for non-compliance. However, the underlying National Health Act 1953 does provide for sanctions in cases of non-compliance with the Act’s provisions. For instance, section 12 of the Act allows for the imposition of fines for breaches of the Act, with penalties that can extend to thousands of Australian dollars depending on the severity of the breach. Additionally, section 14 of the Act allows for imprisonment for more serious breaches. The precise penalties are not detailed within the 2013 Amendment but are governed by the overarching legislative framework of the National Health Act.