Page 4023 - Week 13 - Thursday, 6 December 2007
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1978 regulates the dangerous poisons and includes some specific provisions for the medicines that must only be prescribed by a specialist. This bill therefore seeks to simplify the regulation of medicines and poisons in the territory and to align us with the rest of Australia and current best practice.
Mr Speaker, the bill also seeks to implement the recommendations of the national competition review of drugs, poisons and controlled substances legislation report. This review was completed in 2001 and accepted by the Council of Australian Governments in 2005. A key recommendation of the Galbally review is the development and adoption of model legislation. The nationally agreed position on the regulation of medicines and poisons is reflected in the standard for the uniform scheduling of drugs and poisons, known as the standard. The standard is maintained by the National Drugs and Poisons Schedule Committee established under the Therapeutic Goods Act 9989. This committee includes representatives of each Australian jurisdiction, including the Australian Capital Territory. The standard informs state and territory processes for regulating the manufacture, packaging and labelling, distribution, prescription and supply of medicines and poisons.
The standard is adopted into current state and territory legislation, and the ACT currently adopts some but not all of the provisions. The standard recommends a hierarchy of controls through the grouping of medicines and poisons according to their risk to human health and safety. It does this by grouping substances into schedules so that different levels of controls can be applied according to the expected risks of the substance.
Mr Speaker, the bill seeks to allow the continuation of many of the legally conducted practices involving medicines and poisons in the territory, through an authorisation and licensing scheme. The government recognises that there are a number of stakeholders who are interested in the matters regulated by this bill. Accordingly, we introduced an exposure draft of the bill for community consultation in December 2006. Consultation comments on the exposure draft of the bill were received from a number of stakeholders, including scientific researchers, the police and the aged care industry. As expected, comments were also received from health professionals such as doctors, pharmacists, optometrists, podiatrists and nurses. All the stakeholders’ comments were considered in the redrafting of the bill that I present to the Assembly today.
Mr Speaker, the “Standard for the uniform scheduling of drugs and poisons”, the document that contains the model provisions that this bill seeks to implement, is updated three times each year. Therefore, it is proposed that much of the detail required to implement the standard will be included in the Medicines Poisons and Therapeutic Goods Regulation 2007 that will be subordinate to this bill. This will enable the territory to remain aligned with the states and the Northern Territory, who all adopt the standard.
An exposure draft of the proposed Medicines, Poisons and Therapeutic Goods Regulation 2007 was released for community consultation in February this year. As with the bill, there were a number of submissions received from interested stakeholders. Redrafting of the regulation to incorporate stakeholders’ comments continues. A copy of the proposed regulation will be provided to members of the Assembly prior to the debate of the bill.
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