EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 3)
PB 47 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, effective 1 August 2013, each listed drug which has at least one listed brand to which section 99ADH will apply on 1 August 2013. Section 99ADH deals with price disclosure price reductions.
This instrument amends Part 1 of Schedule 1 to the Principal Determination.
Part 1 sets out the ACE inhibitor group (the Angiotensin converting enzyme inhibitor group). This instrument removes the listed drug ‘Fosinopril’ from this group.
The amending instrument also removes the therapeutic group;
- ACE inhibitor group (the angiotensin converting enzyme inhibitor group)
as subsection 84AG(5) of the Act provides that a therapeutic group must contain at least one listed drug.
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 required under the Act consequential to price disclosure price reductions, is minor and machinery in nature and therefore does not require any additional consultation.
This instrument commences on 1 August 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. 3) was enacted to amend the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010, addressing the need to update the pharmaceutical benefits scheme by removing certain listed drugs from their respective therapeutic groups, effective from 1 August 2013. This amendment was necessitated by the introduction of price disclosure and price reduction measures under section 99ADH of the National Health Act 1953. The determination was made by the Minister for Health under the authority granted by subsection 84AG(1) of the Act, ensuring that therapeutic groups contain at least one listed drug as per subsection 84AG(5). The changes are minor and procedural, focusing on the administrative aspects of the Pharmaceutical Benefits Scheme without requiring additional consultation, as they are considered machinery in nature. The amendment aims to maintain the integrity and effectiveness of the pharmaceutical benefits provided under the National Health Act.
Scope and Application
The National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 3) pertains to the regulation of pharmaceutical benefits under the National Health Act 1953. This legislative instrument modifies the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010, specifically by removing certain drugs from their designated therapeutic groups, effective from 1 August 2013. The amendment is necessitated by the application of section 99ADH, which involves price disclosure and price reductions, thereby impacting the listed drugs and their categorisation within therapeutic groups. The determination applies to the Commonwealth of Australia and affects the Pharmaceutical Benefits Scheme, which provides subsidised access to medicines for patients. The removal of the drug Fosinopril from the ACE inhibitor group exemplifies the adjustments made to therapeutic group listings. The instrument revokes the entire ACE inhibitor group as it no longer meets the requirement of containing at least one listed drug, as per subsection 84AG(5) of the Act. This amendment does not necessitate further consultation as it is deemed minor and consequential to the aforementioned price reductions.
Key Provisions
The main operative sections of the National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2013 (No. 3) (subsection 84AG(1) of the National Health Act 1953) amend the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 (PB 1 of 2010). The amendment removes certain listed drugs from their therapeutic groups, effective from 1 August 2013, specifically targeting drugs with at least one listed brand subject to section 99ADH, which deals with price disclosure and price reductions. In this particular amendment, the drug 'Fosinopril' is removed from the ACE inhibitor group, also known as the angiotensin converting enzyme inhibitor group. Additionally, the ACE inhibitor group itself is removed from the determination, as subsection 84AG(5) of the Act mandates that a therapeutic group must contain at least one listed drug.
The obligations and requirements imposed by this Act on the parties and entities it governs include ensuring that therapeutic groups are appropriately defined and maintained according to the Act's stipulations. This means that pharmaceutical entities and healthcare providers must be aware of the changes in therapeutic group listings, particularly when it comes to drugs like Fosinopril, which are removed from their respective groups. The Act requires these entities to comply with the updated determinations when administering or prescribing drugs, ensuring that the pharmaceutical benefits provided are aligned with the current therapeutic groupings.
Breaches of the Act may lead to civil or criminal consequences, although specific offences, penalties, or consequences are not explicitly detailed within the text provided. Given the legislative context, penalties for non-compliance with the National Health Act 1953 can potentially include fines or other sanctions, which would be in line with the legal frameworks governing health legislation in Australia. It is important for all parties involved to adhere to the amended determinations to avoid any legal repercussions.