Download EXPLANATORY STATEMENT

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.
2
Statement
Compatibility with
Rights
Statement
ofofCompatibility
withHuman
Human
Rights
Prepared
in accordance
3 ofHuman
the Human
Rights
(Parliamentary
Scrutiny)
Prepared
in accordance
with with
Part Part
3 of the
Rights
(Parliamentary
Scrutiny)
Act 2011
Act 2011
National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment
National Health (Pharmaceutical
Benefits
Groups) Amendment
Determination 2013
(No. –3)Therapeutic
(PB 47 of 2013)
Determination 2012 (No. 2) (PB XX of 2012)
This Legislative Instrument is compatible with the human rights and freedoms recognised or
This Legislative
Instrument instruments
is compatible
withinthe
human3 rights
freedoms
declared
in the international
listed
section
of the and
Human
Rights
recognised or declared(Parliamentary
in the international
instruments
listed
in
section
3
of
the
Scrutiny) Act 2011.
Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
Overview of the Legislative Instrument
This Legislative Instrument is made pursuant to subsection 84AG(1) of the National Health
This Legislative
Instrument
pursuant
to subsection
84AG(1)amends
of the National
Act 1953
(the Act), which
relatesistomade
therapeutic
groups.
This instrument
the National
Health
Act 1953 (theBenefits
Act), which
relates to therapeutic
groups. This2010
instrument
Health
(Pharmaceutical
– Therapeutic
Groups) Determination
(PB 1 of 2010)
principle instrument
which determines
a number
of therapeutic
(the amends
Principalthe
Determination)
which determines
a number
of therapeutic
groups groups
and the
and
the
listed
drugs
that
are
in
those
therapeutic
groups.
listed drugs that are in those therapeutic groups. This instrument (the Amending
Determination) amends the Principal Determination by removing the definition of the ‘ACE
inhibitor group’ (the Angiotensin converting enzyme inhibitor group) as this group is no
Human
rights implications
longer
determined
to be a therapeutic group, removes the listed drug fosinopril from this
group,
removesinstrument
the group.engages Article 2 and 12 of the International Covenant on
Thisand
legislative
Economic,
and Cultural Rights (ICESCR) by assisting with the progressive
Human
rightsSocial
implications
realisation by all appropriate means of the right of everyone to the enjoyment of the
This
legislative
instrument
engages
Articleand
2 and
12 ofhealth.
the International Covenant on
highest
attainable
standard
of physical
mental
Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation
Theappropriate
PBS is a benefit
which
withtoadvancement
ofof
this
by
by all
meansscheme
of the right
ofassists
everyone
the enjoyment
thehuman
highestright
attainable
providing
for
subsidised
access
by
patients
to
medicines.
The
recommendatory
role
of
standard of physical and mental health.
the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions
Theabout
Pharmaceutical
Benefits
is aonbenefit
scheme
which assists with advancement of
subsidised access
to Scheme
medicines
the PBS
are evidence-based..
this human right by providing for subsidised access by patients to medicines. The
recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures
thatConclusion
decisions about subsidised access to medicines on the PBS are evidence-based.
This Legislative Instrument is compatible with human rights as it does not raise any
human rights issues.
Conclusion
Adriana
This Legislative Instrument is compatible
with Platona
human rights because it advances the
protection of human
rights.Secretary, Pharmaceutical Evaluation Branch
Assistant
Pharmaceutical Benefits Division, Department of Health and Ageing
Adriana Platona
Assistant Secretary, Pharmaceutical Evaluation Branch
Pharmaceutical Benefits Division, Department of Health and Ageing