Page 2840 - Week 08 - Tuesday, 5 August 2008

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Governments in 2005. A key recommendation of the review was 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, generally cited as the standard.

The standard is maintained by the National Drugs and Poisons Schedule Committee established under the commonwealth Therapeutic Goods Act. This committee includes representatives of each Australian jurisdiction, including the ACT. The standard informs state and territory processes for regulating the manufacture, packaging and labelling, distribution, prescription and supply of medicines and poisons. The standard recommends a hierarchy of controls to the grouping of medicines and poisons according to the risk to human health and safety. It does this by grouping substances into schedules so that different levels of control can be applied according to the expected risk of the substance.

The intention was for the standard to be adopted into state and territory legislation. The ACT currently adopts some but not all of the provisions. Through this bill and the proposed supporting regulations, the standard would be more comprehensively adopted in the territory.

Another recommendation made in the Galbally review was for each jurisdiction to apply the commonwealth Therapeutic Goods Act 1989, to provide uniformity across Australia. The Therapeutic Goods Act provides the national system for regulating therapeutic goods but, due to the limits on the legislative power of the commonwealth, there are gaps in the regulation at the local level. This bill gives effect to that recommendation.

Consultation with stakeholders is something that this government is committed to and takes seriously. An exposure draft of the bill was released in December 2006. An exposure draft of regulations to support the bill followed in January 2007. Consultation comments on the exposure draft of the bill were received from a variety of stakeholders, and I thank those who commented for their time, interest and contribution. Comments were received from scientific researchers, the police and the aged care industry. Not surprisingly, there was also considerable interest and comments from health professionals such as doctors, pharmacists, optometrists, podiatrists and nurses.

All stakeholder comments were considered and contributed to the evolution of the bill from the exposure draft that was released in December 2006 to the bill being debated today. However, whilst all comments were considered, it is never possible to incorporate all of them. For example, there were some comments and inclusions sought that would have been inappropriate to incorporate into the bill, as the changes could have been anticompetitive or inconsistent with the recommendations of the Galbally review.

As stated earlier, the bill seeks to consolidate territory legislation about the supply of medicines, poisons and therapeutic goods. Nevertheless, it is important to recognise that there are inevitably some matters directly or indirectly associated with the supply of medicines, poisons and therapeutic goods that are currently and more appropriately located in other legislation.

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