James Bidgood (Dawson, Australian Labor Party) Share this | Hansard source

I rise to speak in favour of the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008. As a previous owner of two medical centres that service the healthcare needs of 40,000 people in the electorate of Dawson, I welcome this bill. I have seen firsthand the benefit of medical science working hand-in-hand with complementary medicines and alternative therapies—’complementary’ being the key word. This bill provides for medicines to be approved if they meet specific criteria, or disapproved if they do not. I welcome this because I often come across previous patients, and also people who come in for consultations at my office, who ask for amendments such as this. I know that this bill will be welcomed by many people, particularly in my electorate, who I have seen benefit from different types of therapeutic goods.

Schedule 1 of the bill provides for medicines to be suspended from the register—and, as we know, medical devices can already be suspended. Schedule 2 requires manufacturing licences to cover single manufacturing sites, except in limited circumstances provided for in guidelines, and enables variations to licences and transfer of licences between licence holders. Schedule 3 enhances monitoring powers to enable samples to be taken of any therapeutic good or any thing related to a therapeutic good on premises and to enable video and other recordings to be taken in addition to still photographs and sketches. Schedule 4 establishes a framework for the regulation of homoeopathic and anthroposophic medicines to commence in July 2011 with supporting regulations to be made to commence at that time. I am particularly interested in schedule 4. Currently, many of these homoeopathic and anthroposophic medicines are exempt from the requirement under the act that they be included in the register and meet manufacturing requirements. The bill now provides a framework for the regulation of these medicines and, in doing so, implements the 2003 recommendation by the Expert Committee on Complementary Medicines in the Health System that these products be regulated. This means that we will have conditions that recognise what truly does work, and we will avoid snake oil type therapeutic goods which clearly do not work. This enables these determinations to be made.

Schedule 5 of the bill enables the minister to determine lists of permitted and prohibited ingredients for inclusion in listed medicines. Schedule 6 makes minor technical amendments to references to orders published in the Gazette and to disallowable instruments to reflect that they are legislative instruments for the purposes of the Legislative Instruments Act 2003. Finally, schedule 6 makes other amendments to improve and clarify the operation of the act, including simplifying arrangements for setting conditions on medicines and confirming that decisions of the secretary may be made by a computer program.

The act presently enables medical devices to be suspended from the Australian Register of Therapeutic Goods, known as the register, when there are safety concerns with those goods. However, there are presently no similar provisions for medicines; therefore, if there are safety concerns with a medicine, the only option available to the secretary is to cancel its registration or listing. After addressing the reason for the cancellation, the sponsor must then reapply and pay the related application and assessment fees to re-register or relist the medicine. This is costly and inefficient. This bill provides that medicines can be suspended instead, when there are safety concerns that may be addressed within the period of the suspension.

The bill provides that manufacturing licences are to cover one site per licence, except in limited circumstances to be identified in guidelines, such as when two sites are adjacent to one another and jointly manufacture the same therapeutic good. Licence holders will also be able to apply to vary their licence, and the regulations will set out arrangements to enable the transfer of licences. Presently, many homeopathic and anthroposophic medicines are exempt from requirements under the act to be listed or to comply with quality manufacturing requirements. The bill implements a recommendation from 2003 of the expert committee on complementary medicine to regulate these products in the health system. The amendments will commence in July 2011 to provide time for further consultation with the industry sector to inform supporting regulations.

The regulations currently provide for permitted ingredients in listed medicines; however, the arrangements for amending this list and seeking to include new ingredients are not as clear as they might be. This bill clarifies this by empowering the minister to determine the list by legislative instrument, setting out permitted and prohibited ingredients and amounts of ingredients for listed medicines.

This bill also implements a number of minor amendments to clarify and improve the operation of the act. These amendments are, firstly, to clarify the arrangements for setting conditions on medicines and empowering the minister to determine standard conditions to apply to categories of medicines, with the secretary continuing to be able to set specific conditions on certain medicines; secondly, to clarify that computer programs are able to be used to make decisions for the secretary, with the secretary retaining the ability to replace those decisions; thirdly, to enable applicants to apply for a previous request to have an application to list or register a medicine that was treated as cancelled revoked so as to enable the application for the medicine to be considered; and, fourthly, to strengthen overseas manufacturing quality requirements for medicines by requiring that, before the manufacture of a medicine can be moved to an overseas manufacturer, certification must be received from the secretary that the manufacturing and quality control procedures for the proposed overseas manufacturer are acceptable.

This bill makes a number of minor technical amendments to references to orders and disallowable instruments to reflect that these are legislative instruments for the purpose of the Legislative Instruments Act 2003.

Finally, further amendments are planned for later in the year to establish a new framework for the regulation of human cellular and tissue based therapy products, biologicals, and new arrangements for the separate scheduling of medicines and poisons to reflect recommendations from the 2001 Galbally review and decisions from the Council of Australian Governments. I wholeheartedly commend this bill to the House.

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