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EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment
Determination 2012 (No.1)
PB 16 of 2012
Authority
This legislative instrument is made pursuant to subsection 84AG(1) of the National Health
Act 1953 (the Act), which relates to therapeutic groups.
Purpose
This legislative instrument amends the National Health (Pharmaceutical Benefits –
Therapeutic Groups) Determination 2010 (PB 1 of 2010) (the Principal Instrument), 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 April 2012, each listed drug which
has at least one listed brand to which section 99ADH will apply on 1 April 2012. Section
99ADH deals with price disclosure price reductions.
The amending instrument also removes the therapeutic groups:
 CCB group (the Dihydropyridine calcium-channel blocker group); and
 Statins group (the HMG Co-A reductase inhibitor group)
as subsection 84AG(5) of the Act provides that a therapeutic group must contain at least
one listed drug.
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 April 2012.
This instrument is a legislative instrument for the purposes of the Legislative Instruments
Act 2003.
A provision-by-provision description of this instrument is contained in the Attachment.
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ATTACHMENT
DETAILS OF THE NATIONAL HEALTH (PHARMACEUTICAL BENEFITS –
THERAPEUTIC GROUPS) AMENDMENT DETERMINATION 2012 (No.1)
Section 1
Name of Determination
This section provides that the name of this instrument is the National Health
(Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2012 (No.1)
and that it may also be cited as PB 16 of 2012.
Section 2
Commencement
This section provides that this instrument commences on 1 April 2012.
Section 3
Amendments to PB 1 of 2010
This section provides that Schedule 1 amends the National Health (Pharmaceutical
Benefits – Therapeutic Groups) Determination 2010 (PB 1 of 2010) (the Principal
Instrument).
Schedule 1
Amendments
Item 1 amends section 4 of the Principal Instrument to remove the definition of the ‘CCB
group’ (the Dihydropyridine calcium-channel blocker group), as this group is no longer
determined to be a therapeutic group.
Item 2 amends section 4 of the Principal Instrument to remove the definition of the ‘Statins
group’ (the HMG Co-A reductase inhibitor group), as this group is no longer determined to
be a therapeutic group.
Item 3 amends Part 1 of Schedule 1 to the Principal Instrument. Part 1 sets out the ACE
inhibitor group (the Angiotensin converting enzyme inhibitor group). Item 3 removes the
listed drugs ‘Captopril’ and ‘Enalapril’ from this group.
Item 4 amends Part 1 of Schedule 1 to the Principal Instrument. Part 1 sets out the ACE
inhibitor group (the Angiotensin converting enzyme inhibitor group). Item 4 removes the
listed drugs ‘Lisinopril’, ‘Perindopril’, ‘Quinapril’, ‘Ramipril’ and ‘Trandolapril’ from this
group.
Item 5 removes all listed drugs in the CCB group (the Dihydropyridine calcium-channel
blocker group), and removes the CCB group, from the Principal Instrument by omitting the
entry for Part 3 of Schedule 1 to the Principal Instrument.
Item 6 amends Part 4 of Schedule 1 to the Principal Instrument. Part 4 sets out the H2RA
group (the H2 receptor antagonist group). Item 6 removes the listed drug ‘Famotidine’
from this group.
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Item 7 amends Part 5 of Schedule 1 to the Principal Instrument. Part 5 sets out the PPI
group (the Proton pump inhibitor group). Item 7 removes the listed drugs ‘Lansoprazole’,
‘Omeprazole’ and ‘Pantoprazole’ from this group.
Item 8 removes the all listed drugs from the Statins group (the HMG Co-A reductase
inhibitor group), and removes the Statins Group, from the Principal Instrument by omitting
the entry for Part 6 of Schedule 1 to the Principal Instrument.
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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.1) (PB 16 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 does not engage any of the applicable rights or freedoms.
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