EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2012 (No. 2)
PB 80 of 2012
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 therapeutic groups and the listed drugs 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 add the listed drug losartan to the Angiotensin II receptor antagonist group (ATRA) therapeutic group, effective 1 October 2012.
The PBAC advised in July 2010 that the drug losartan should be treated as interchangeable on an individual patient basis with the drugs in the existing ATRA therapeutic group: candesartan, eprosartan, irbesartan, olmesartan, telmisartan and valsartan.
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 mattters. 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.
Pharmaceutical companies affected by the Amending Determination were consulted in writing on two occasions concerning the addition of losartan to the ATRA therapeutic group.
This Amending Determination commences on 1 October 2012.
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 2012 (No. 2) was enacted to address the need for updating the therapeutic groups and associated listed drugs under the National Health Act 1953. This Act was established to provide for national health services and pharmaceutical benefits, and the 2012 Amendment Determination serves to refine the classification of drugs within therapeutic groups. The determination was made by the Minister for Health under the authority granted by subsection 84AG(1) of the National Health Act 1953, with the objective of aligning the Pharmaceutical Benefits Scheme with the latest therapeutic recommendations. Specifically, it was introduced to add the drug losartan to the Angiotensin II receptor antagonist group, following advice from the Pharmaceutical Benefits Advisory Committee (PBAC). This change aims to ensure that patients have appropriate and cost-effective access to essential medications by treating certain drugs as interchangeable within their therapeutic groups.
Scope and Application
The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2012 (No. 2) applies to the Minister for Health under the National Health Act 1953. It amends the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 to include the drug losartan in the Angiotensin II receptor antagonist group (ATRA) therapeutic group, effective from 1 October 2012. This amendment follows advice from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body established under the Act. The PBAC advises on which drugs and medicinal preparations should be available as pharmaceutical benefits. The Amending Determination also involves consultation with pharmaceutical companies affected by the changes. The determination is made under the authority of the National Health Act 1953, which operates at a Commonwealth level, and any subordinate instruments extending or restricting application would be subject to the same jurisdictional reach. There are no stated exclusions, exemptions, or thresholds in this particular legislative instrument.
Key Provisions
The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2012 (No. 2) (PB 80 of 2012) amends the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 by adding the drug losartan to the Angiotensin II receptor antagonist group (ATRA) therapeutic group, effective from 1 October 2012 (section 2). This amendment is made in response to advice from the Pharmaceutical Benefits Advisory Committee (PBAC), which recommended that losartan be treated as interchangeable on an individual patient basis with the existing drugs in the ATRA therapeutic group (section 3). The purpose of this determination is to ensure that losartan is included in the PBS schedule as a pharmaceutical benefit, thus allowing for subsidised access to this drug for patients (section 4).
The Act imposes obligations on the Minister for Health to make determinations about therapeutic groups and listed drugs, based on recommendations from the PBAC (section 84AG(1)). The PBAC, an independent expert body established under the Act, is responsible for advising the Minister on which drugs should be available as pharmaceutical benefits (section 100A). Pharmaceutical companies affected by the determinations are required to consult with the Minister on the inclusion of their drugs in the therapeutic groups (section 84AG(3)). The Minister must also ensure that the determinations are compatible with human rights, as per the Human Rights (Parliamentary Scrutiny) Act 2011 (section 10).
The Act does not specify any offences, penalties, or consequences for breach of the therapeutic group determinations. However, the Minister's failure to comply with the requirements of the Act or the determinations could potentially result in legal challenges or administrative actions. The determinations themselves are legislative instruments made under the authority of the National Health Act 1953, and their validity and enforceability are subject to the provisions of the Legislative Instruments Act 2003 (section 10). The Minister must ensure that the determinations are consistent with the Act and do not contravene any other applicable laws or human rights (section 10).