Page 410 - Week 01 - Thursday, 16 February 2012
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by a person who is not authorised to supply the medicine is an offence attracting a maximum penalty of 500 penalty units and/or imprisonment for 5 years (s26 MPTG Act).
(3) The Medicines, Poisons and Therapeutic Goods Act 2008 (MPTG Act) governs all medicine related dealings in the ACT. Specific sections citing these offences are mentioned above.
Kava is listed as a prescription only medicine under the Standard for Uniform Scheduling of Medicines and Poisons (SUSMP), which is adopted by reference under the MPTG Act. The SUSMP and the listing for kava therein are enacted in all other Australian States and Territories in their respective medicines legislation.
(4) The above standard is given effect within the ACT, and lists restrictions on the supply and labelling of kava as a food product. However, the standard also states that it should be considered in conjunction with other State and Territory restrictions and further that ‘Where kava is permitted for supply, the requirements in this Standard complement those restrictions.’
Therefore, as cold water extracts of kava root are only permitted for supply by way of prescription under medicines law, the Australia and New Zealand Food Standards Code does not apply in this setting.
(5) The decision to reschedule kava to a prescription only medicine was not made by the ACT Government. The ACT Government adopts medicines scheduling decisions in Territory legislation by way of the SUSMP, as do all other States and Territories. Scheduling decisions, including the decision to list kava as prescription only, are made by an independent statutory committee under the Therapeutic Goods Administration. ACT Health has representation on this committee, as do all other jurisdictions.
Summaries of all rescheduling decisions are published on the TGA website under Record of Reasons. The decision to list kava as a prescription only medicine was based on reports of abuse of kava mainly in Northern Territory communities, and also evidence of liver toxicity and death associated with kava use. The decision to reschedule was made on balance against risk to broader public health, and not due to adverse health effects on Pacific Islander people who use it for cultural purposes.
(6) The ACT Government has not sought comparative evidence on the health impacts of alcohol vs kava. However, importantly, this type of evidence would have little impact on kava legislation as the laws governing the supply of alcohol and medicines are separate. Furthermore, the comparative risk of a medicine against alcohol consumption is not a standard criteria against which medicines are scheduled. Rather, scheduling decisions are based upon the severity and risk of toxicity of a substance, its use and potential for abuse.
(7) The issue of kava regulation has been a matter of national concern for many years and opportunities for consultation and dialogue with the Pacific Islands communities have been afforded at the Commonwealth level.
In specific relation to the scheduling of kava, the TGA calls for public comment on rescheduling submissions and publish decisions on their website as part of usual process. I understand that the TGA offered an extended period of consultation for this submission however no public submissions were received for this meeting.
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