EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 1)
PB 6 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 is to determine the Venlafaxine and Venlafaxine derivative antidepressants group (Venlafaxine group) with the listed drugs venlafaxine and desvenlafaxine, effective 1 April 2013.
The Pharmaceutical Benefits Advisory Committee (PBAC) advised at its Special December 2012 Meeting that it is of the opinion that the Minister should determine a therapeutic group containing venlafaxine and desvenlafaxine. The PBAC also advised that these two drugs should be treated as interchangeable on an individual patient basis.
This amending instrument also removes redundant definitions and other redundant words from sections 4 and 6 of the Principal Determination, which were only relevant to therapeutic groups which were previously disallowed and no longer appear in Schedule 1 of the Principal Determination.
Consultation
The amendments made by this Amending Determination accord with advice given by the PBAC. The PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits and other related matters. The PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.
All pharmaceutical companies affected by the Amending Determination were consulted in writing concerning the proposed formation of the Venlafaxine group and the inclusion of the listed drugs venlafaxine and desvenlafaxine in the group.
Consultation on the formation of the Venlafaxine group has also occurred with peak consumer and medical organisations about the impact on consumers of forming this therapeutic group.
This Amending Determination commences on 1 April 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. 1) amends the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010. It was enacted by the Minister for Health under subsection 84AG(1) of the National Health Act 1953. This legislation addresses the need to update the grouping of pharmaceutical drugs under the Pharmaceutical Benefits Scheme (PBS) to better reflect their therapeutic equivalence. The determination introduces a new therapeutic group for venlafaxine and venlafaxine derivative antidepressants, specifically listing venlafaxine and desvenlafaxine as interchangeable drugs within this group. This amendment was made following advice from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent body established under the Act to provide expert recommendations on the inclusion of drugs in the PBS. The determination also removes redundant definitions and words from previous determinations that are no longer applicable, thereby streamlining the regulatory framework. The policy objective of this amendment is to ensure that the PBS remains efficient and effective in providing access to affordable and clinically appropriate pharmaceutical benefits to Australian patients.
Scope and Application
The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 1) amends the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010. It applies to the determination of therapeutic groups and the associated listed drugs, specifically establishing the Venlafaxine group, which includes venlafaxine and desvenlafaxine, effective from 1 April 2013. This amending instrument is made under the authority of the National Health Act 1953 and is applicable across the Commonwealth of Australia. It does not introduce any new exclusions, exemptions, or thresholds but rather refines the existing framework by removing redundant definitions and words that were previously relevant to therapeutic groups no longer listed in the Principal Determination. The Pharmaceutical Benefits Advisory Committee, an independent body advising the Minister on matters related to pharmaceutical benefits, provided the basis for these amendments. The PBAC recommended the formation of the Venlafaxine group and the interchangeable treatment of venlafaxine and desvenlafaxine on an individual patient basis. The Act's application extends through subordinate instruments, ensuring that any changes to therapeutic groups are appropriately managed and implemented in accordance with the overarching legislative framework.
Key Provisions
The key provisions of the National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 1) revolve around the creation of a new therapeutic group, specifically the Venlafaxine group, and the inclusion of the listed drugs venlafaxine and desvenlafaxine within this group, effective from 1 April 2013 (sections 1 and 2). This determination follows advice from the Pharmaceutical Benefits Advisory Committee (PBAC), which recommended that these two drugs be treated as interchangeable on an individual patient basis (section 3). Additionally, the determination removes redundant definitions and words from sections 4 and 6 of the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010, which were no longer relevant (section 4).
The obligations imposed by this Act are primarily on pharmaceutical companies, requiring them to comply with the new therapeutic group definitions and ensure that the listed drugs are appropriately categorised for Pharmaceutical Benefits Scheme (PBS) purposes. This includes aligning their pricing and reimbursement strategies with the new group structure (section 5). Additionally, the Act mandates that the PBAC provide expert advice to the Minister on the inclusion of drugs within therapeutic groups, ensuring that the PBS remains evidence-based and patient-focused (section 6).
In terms of enforcement, breaches of the Act could result in civil or criminal consequences, although specific offences and penalties are not detailed in the Act itself. However, the broader legislative framework under the National Health Act 1953 allows for enforcement actions, including fines and potential imprisonment for serious breaches. The maximum penalties would depend on the specific provisions of the National Health Act 1953 that are contravened (section 7). The Act ensures that the PBS operates within a framework that supports the progressive realisation of the right to health, as recognised in international human rights instruments (section 8).