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MEDICINES, POISONS AND THERAPEUTIC GOODS (KAVA EXEMPTION) AMENDMENT REGULATION 2013 (NO 1) (NO 1 OF 2013)
Legislative Assembly for the
Australian Capital Territory
Medicines, Poisons and Therapeutic Goods
(Kava Exemption) Amendment Regulation 2013 (No 1)
SL2013-1
Explanatory Statement
Circulated by the authority of
Katy Gallagher
MLA
Minister for Health
January 2013
Medicines, Poisons and Therapeutic Goods (Kava Exemption) Amendment Regulation 2013 (No1 )
Explanatory Statement
Overview
The Medicines, Poisons and Therapeutic Goods
Act 2008 (the MPTG Act) adopts the Standard for the Uniform Scheduling
of Medicines and Poisons (the SUSMP). The MPTG Act refers to this as the
‘medicines and poisons standard’.
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
MPTG Act provides under section 190 that a regulation may exempt a person,
regulated thing, premises or dealing with a regulated thing, or anything else
from the operation of the MPTG Act. A regulation may also authorise the
Minister to issue an exemption. This power was included as there are
circumstances where it may be appropriate for regulatory or policy reasons that
an exemption be given. The MPTG Act provides a safeguard by requiring an
exemption to be public knowledge.
Piper Methysticum (kava) is
listed as a prescription-only substance under Schedule 4 of the SUSMP with
corresponding restrictions under the MPTG Act. As such, its possession and use
is illegal if there is no valid prescription.
This Regulation amends the
Medicines, Poisons and Therapeutic Goods Regulation 2008 (the MPTG
Regulation) to insert a new section; section 864. The new section exempts
the cultural use of kava at public events declared by the Minister by notifiable
instrument, and subject to any conditions imposed in the declaration.
This Regulation recognises the role that kava plays in Pacific island
culture, and through the application of the exemption enables those cultures and
their customs to be performed and showcased at applicable public
events.
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 (Kava Exemption)
Amendment Regulation 2013 (No 1).
Clause 2 Commencement
Pursuant to this provision, the
Regulation is to commence on the day after notification.
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 New section 864
Section 190(1) (a) of the MPTG Act permits the MPTG Regulation
to make exemptions from the operation of the MPTG Act. Exemptions can concern
persons, premises, dealings, or regulated substances. Utilising this power,
clause 4 inserts into the MPTG Regulation a new provision,
section 864, exempting kava from the prescription only requirements of the
MPTG Act. The exemption will allow certain forms of dealing with kava at
declared public events, provided that the dealing is in accordance with the
customs of the Pacific islands.
Using the rhizome of the Piper
Methysticum plant, an aqueous dispersion or extract can be prepared, which
when consumed orally can have a sedative, anxiolytic or anaesthetic like effect.
Both the plant and the concoction made from its rhizome are commonly referred to
as kava. The potential adverse effects from consumption of kava, including
liver toxicity from medicinal formulations and the potential for adverse health
and social effects due to abuse and misuse of kava, are key reasons why it has
been listed as a prescription-only substance under Schedule 4 of the SUSMP.
Schedule 4 of the SUSMP is automatically adopted under the MPTG Act with
corresponding restrictions. As such, the possession and use of kava is illegal
if there is no valid prescription.
The first subsection in
section 864 exempts kava in four forms.
Using powder made from the
dried rhizome of the kava plant, an aqueous dispersion or aqueous extract of
kava can be prepared. Preparations of kava in this form, if for oral use by
humans, are exempted by virtue of subsection 1(d).
An aqueous
dispersion or extract can also be prepared using either both raw or dried
rhizome, which can be whole or peeled. Preparations of kava in this form are
also exempted by subsection 1(c), again provided that the preparation is
for oral use by humans.
It would be illogical and impractical to exempt
aqueous dispersions or extracts containing raw or dried rhizome, or a powder
made from dried rhizome, without authorising the possession of the rhizome from
which the preparation is to be made. To that end, subsection 1(a) exempts
raw and dried rhizome, whether whole or peeled, and subsection 1(b) exempts
powder made from dried rhizome, provided in both cases that it is for use in an
aqueous dispersion or extract which is intended to be consumed by
humans.
The exemptions created in subsection 1 are not absolute.
For the exemptions to operate, two critical requirements set out in
subsection 2 must be met. The first requirement is that the kava be
prepared, possessed and consumed in accordance with the customs of the Pacific
islands.
A number of nations and states that make up the Pacific islands
are known to prepare and consume kava, including Fiji, Samoa, Tonga, Vanuatu,
New Guinea and Hawaii. There are slight variations in the recognised customs of
Pacific islands surrounding kava preparation and consumption. Nevertheless, in
most customs the kava is prepared and consumed, or both as part of kava
ceremony. This will often involve a gathering of people, in many instances in a
‘kava circle’, and the kava being served or drunk from a traditional
‘kava bowl’.
Accordingly, for the exemption to apply the
kava usage must be consistent with recognised customs of a Pacific island
nation. This is reflective of the fact that the exemption is more about
enabling a celebration of the culture and customs of Pacific island peoples than
about permitting kava preparation and consumption.
The other critical
requirement for the exemption to operate is that the kava is prepared, possessed
and consumed in connection with an event declared by the Minister. Such a
declaration is, by virtue of subsection 5, a notifiable instrument. The
Legislation Act sets out what constitutes a notifiable instrument, and requires
that notifiable instruments be notified on the ACT Legislation Register
website.
Under subsection 3 the Minister may only declare public
events, such as the National Multicultural Festival. It is important that this
provision be interpreted applying the ordinary common meaning of ‘public
event’. It must be open to the community at large. The exemption cannot
be applied to permit the preparation and consumption of kava at private events,
such as birthdays and weddings.
In declaring a public event to
which the exemption will apply, the Minister may impose any condition on the
event or the usage of kava that the Minister considers appropriate. Some public
events, such as the National Multicultural Festival, run over several days,
extend into the evenings, and can take place over a large area. The ability of
the Minister under subsection 4 to impose conditions recognises that it may
be necessary to limit the exemption to a single day of an event, or during
certain hours of an event. It is also common for some public events to take
place at multiple locations. Where this is the case, a condition can be imposed
that would specify at which site or sites the exemption will apply.
It
may also be necessary to require signage for the event. This may be to alert
the public about the operation of other conditions, such as approved times and
locations. It is also important to recognise that it is unlikely that every
person attending a public event will be familiar with kava and its effects. It
would therefore be reasonable for the Minister to require that signs or
information be available alerting the public to the effects of kava consumption,
and offering cautionary warnings such as the importance of not operating a motor
vehicle following consumption of kava.
The conditions specified in
paragraphs (a) to (e) of subsection 4 are not an exhaustive list of
conditions that may be imposed, but should rather be regarded as conditions that
are most likely to be imposed for most declared events. Paragraph (f)
contemplates that other conditions may be imposed, which may be a standard
condition imposed on all declared events, or conditions specific to an event or
a point in time.
An example of a condition not listed in the subsection
that is likely to be commonly imposed would be a condition effectively
prohibiting kava from being sold, including in exchange for a
‘donation’ or as part of a fundraising activity. The Minister may
regard it as inappropriate for persons to sell kava at a public event, thereby
profiting from the exemption given. The Minister may also regard that the sale
of kava is inconsistent with the intent of an exemption for cultural purposes,
as it may encourage excessive or non-cultural use. The imposition of a condition
preventing sale of kava would put the matter beyond doubt, and would ensure an
exemption created to enable the celebration of Pacific island culture is not
abused for profit or financial gain.
The importation of kava is
restricted by Commonwealth Customs legislation. Kava may only be imported for
medical and/or scientific purposes and only under a Licence to Import
Controlled Substances and an import permit. Nevertheless, there is an
exemption to the requirements of the Australian Customs Service that allows an
incoming passenger on a ship or aircraft to bring kava to Australia without an
import permit if:
• the incoming passenger is aged 18 years or over;
• the kava is in either root or dried powder form;
• the amount of kava does not exceed 2 kilograms; and
• the kava is carried in the passenger's accompanied baggage.
It
is intended that the use of kava in relation to this exemption be consistent
with Commonwealth importation restrictions.
It should be noted that as
the Minister’s authority does not extend beyond the Australian Capital
Territory the Minister cannot declare an event occurring outside the Territory
to be a public event. This, by extension, will prevent kava from being prepared
or consumed outside of the Territory, or for persons to possess or supply kava
outside of the ACT.
Similarly, many Commonwealth agencies are not bound
by the MPTG Act. Should a Commonwealth agency be considering organising a
public event at which they would like kava to be prepared and consumed, that
agency will need to obtain its own legal advice as to whether it is subject to
the MPTG Act.
Finally it is important to emphasise that nothing in the
exemption is meant to encourage the use of kava as part of daily living. Kava
is otherwise only permitted in preparations on prescription by a
doctor.
Restricting the application of the exemption to declared public
events has been done not just to prevent the day to day use of kava, but to also
ensure that the exemption can be applied only for events of special importance
to the ACT community.