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MEDICINES, POISONS AND THERAPEUTIC GOODS AMENDMENT REGULATION 2013 (NO 1) (NO 24 OF 2013)
Legislative Assembly for the
Australian Capital Territory
Medicines, Poisons and Therapeutic Goods
Amendment Regulation 2013 (No 1)
SL2013-24
Explanatory Statement
Circulated by the authority of
Katy Gallagher
MLA
Minister for Health
August 2013
Medicines, Poisons and Therapeutic Goods Amendment Regulation 2013 (No1)
Explanatory Statement
Overview
The Therapeutic Goods Administration (TGA)
administers the Standard for the Uniform Scheduling of Medicines and Poisons
(the SUSMP), which classes medicines and poisons into schedules. The ACT adopts
the SUSMP under the Medicines, Poisons and Therapeutic Goods
Act 2008 (the MPTG Act) to regulate the supply of scheduled
medicines in the ACT. The SUSMP also contains appendices which subject some
substances listed in the schedules to additional exceptions or restrictions.
The objective of the MPTG Act is to promote and protect public health
and safety by minimising medicinal misadventure with, and diversion of,
regulated substances, and the manufacture of regulated substances that are
subject to abuse. The MPTG Act also has the purpose of ensuring that consumers
of prescription and non-prescription medicines have adequate information to
allow them to use medicines safely and effectively. The MPTG Act outlines a
range of offences relating to dealings with regulated substances according to
their listing in the SUSMP.
The Medicines, Poisons and Therapeutic Goods
Regulation (the MPTG Regulation) provides the detail for the regulatory
framework established by the MPTG Act. The MPTG Regulation sets out which
health professionals are able to prescribe, administer and dispense medicine,
and conditions relating to such dealings. Some provisions of the MPTG
Regulation prescribe additional information required for licences or
authorisations, whereas other provisions impose statutory licence conditions.
There are also provisions of the Regulation specifying requirements for
activities such as labelling or packaging.
The TGA has announced a change
to the Appendix D entry for nabiximols under the SUSMP that is to commence on
1 September 2013. Nabiximols is a cannabinoid medicine that delivers
a similar therapeutic effect to cannabis. It is used to treat patients with
moderate to severe spasticity secondary to multiple sclerosis. Nabiximols is
commonly referred to by its trading name ‘Sativex’.
At
present nabiximols fall with paragraph 3 in Appendix D of the SUSMP,
which requires that prescribers seek approval from the Secretary of the
Commonwealth Department of Health and Ageing to be able to prescribe nabiximols.
The change to the SUSMP announced by the TGA will move the nabiximols entry
under Appendix D of the SUSMP from paragraph 3 to paragraph 1.
This will remove the requirement to seek approval from the Secretary of the
Commonwealth Department of Health and Ageing, and would instead restrict the
prescribing of nabiximols to authorised medical practitioners.
Sativex
has not been previously available in Australia. It is intended to become
available from October 2013 following the TGA’s approval of the
product onto the Australian Register of Therapeutic Goods. The TGA’s
approval of the product is conditional upon it being prescribed by specialist
physicians practising in neurology or rehabilitation.
While changes to
the SUSMP are automatically adopted under the Act, local prescriber restrictions
for Appendix D medicines are noted in Schedule 3 of the Regulation and
require amendment to give Appendix D standing approval to allow for
specialist prescribing of nabiximols.
An additional update to
Schedule 3 of the Regulation is also required to give standing
Appendix D prescribing approval for the medicine corifollitropin alfa
to specialists practising in endocrinology, gynaecology or obstetrics. This
amendment is consistent with Appendix D updates to the SUSMP in
August 2010 that were previously overlooked. Corifollitropin alfa is
used for ovarian stimulation in women undergoing in-vitro fertilisation.
A detailed explanation of each clause of the Regulation
follows.
Clauses
Clause 1 Name of
Regulation
The first clause of the Regulation declares the name of the
Regulation to be the Medicines, Poisons and Therapeutic Goods Amendment
Regulation 2013 (No 1 ).
Clause 2 Commencement
Pursuant to this provision, the
Regulation is to commence on 1 September 2013.
Due to the
operation of section 75(1) of the Legislation Act 2001 (the
Legislation Act) the naming and commencement provisions of this Regulation,
clauses 1 and 2, commence automatically on the day the Regulation is
notified. A note to that effect is included in the
provision.
Clause 3 Legislation amended
This provision
alerts the reader that this Regulation amends the MPTG Regulation.
Upon
commencement this Regulation will alter the MPTG Regulation in accordance with
the provisions that this Regulation contains. This Regulation will then be
immediately repealed.
Consequentially, from the date that this
Regulation commences a new republication of the MPTG Regulation will be
available. That new republication will feature the alterations made by this
Regulation.
Clause 4 Schedule 3, part 3.2, item 2,
column 3
The focus of Schedule 3 is standing approvals for designated
Appendix D medicines. The Schedule consists of two Parts. Part 3.1
of the Schedule defines the four different approval conditions that are then
placed upon certain specialist doctors by Part 3.2. Appendix D
medicines are listed in the SUSMP.
Item 2 in Part 2.3 of
Schedule 3 relates to specialists practising in the specialist areas of
endocrinology, gynaecology or obstetrics. Item 2 lists in the third column
already lists eight Appendix D medicines that specialists in this area may
prescribe. This provision adds corifollitropin alfa for human use to the
medicines listed in column 3, consistent with the changes to the SUSMP
being made by the TGA. Corifollitropin alfa is used for ovarian
stimulation in women undergoing in-vitro fertilisation.
Clause 5 Schedule 3, part 3.2, new item 5
The focus of Schedule 3 is standing approvals for designated
Appendix D medicines. The Schedule consists of two Parts. Part 3.1
of the Schedule defines the four different approval conditions that are then
placed upon certain specialist doctors by Part 3.2. Appendix D
medicines are listed in the SUSDP.
This provision inserts a new item 5
into Part 2.3 of Schedule 3. The effect of item 5 is to
authorise specialists practising in the specialist area of neurology or
rehabilitation, listed in column 2, to prescribe nabiximols; the medicines
listed in column 3. Column 4 is left empty, reflecting that no
special conditions are imposed on the prescribing. Nabiximols is a cannabinoid
medicine that delivers a similar therapeutic effect to cannabis. It is used to
treat patients with moderate to severe spasticity secondary to multiple
sclerosis