Nicola Roxon (Gellibrand, Australian Labor Party, Shadow Minister for Health) Share this | Hansard source

I rise to speak on the Therapeutic Goods Amendment Bill 2007. Labor supports this bill. The purpose of the bill, as the Parliamentary Secretary to the Minister for Transport and Regional Services has outlined, is to amend the Therapeutic Goods Act 1989 to effectively extend the transition period enabling therapeutic devices currently listed or registered on the Australian Register of Therapeutic Goods to be entered in the ARTG as medical devices under the regulatory scheme introduced by the government in 2002. The bill also makes consequential amendments to two other acts. Labor will support passage of the bill through the parliament.

By way of some background, the Australian Register of Therapeutic Goods is a computer database of therapeutic goods established under the Therapeutic Goods Act and administered by the Therapeutic Goods Administration. Therapeutic goods listed on the register are divided broadly into two classes: medicines and medical devices. The new regulatory framework for medical devices is contained in chapter 4 of the act, which commenced operation on 4 October 2002. The new regulatory framework provided for two transition periods to enable therapeutic devices currently listed or registered on the ARTG under the old regulatory scheme, set out in chapter 3 of the act, to be entered on the ARTG as medical devices under the new scheme by 4 October 2004 or 4 October 2007.

The first transition period that ended on October 2004 required sponsors of previously exempt medical devices and some medical devices that were no longer excluded from the operation of the act to have their devices included on the ARTG. The second transition period, established in section 9B(2) of the act, is due to expire soon—on 4 October 2007. The effect of that current section is that therapeutic devices registered or listed under chapter 3 will be taken to have been cancelled on 4 October 2007 or, if entered on the ARTG as an included medical device under chapter 4 of the act before that date, the date on which the inclusion takes effect. The effect of cancelling the registration or listing of a therapeutic device under chapter 3 would be to prevent the sponsor of those devices from being able to market them to the general public.

The need for the amendments before us today arises because of delays in implementing the new regulatory scheme for medical devices introduced by the government in 2002. The introduction of that scheme necessitated that more than 30,000 medical devices be reassessed by the TGA in order to transition from the old to the new scheme. We understand from both the government and industry groups that this requirement for reassessment has posed significant challenges to both the TGA and the medical device industry, with the result that it now appears that all of the necessary reassessments may not be completed by the 4 October transition deadline. The amendment in this bill seeks to effectively extend the transition period to allow for that to happen. The bill replaces the existing requirements for medical device sponsors to have their products entered on the ARTG as included medical devices by 4 October 2007 with the requirement to lodge an application with the intention of transitioning their products to the new scheme by 4 October 2007.

These amendments effectively allow for the continued supply of devices until such time as the TGA has completed its assessment of the compliance of the device, rather than mandatory cancellation on 4 October 2007. In the absence of these amendments some medical devices would be prevented from being marketed for public use, not only adversely affecting the commercial supply of medical devices to the general public and interrupting access by patients and health practitioners but also potentially undermining the domestic medical devices industry, with particular commercial disadvantage for sponsors of such devices.

Labor have sought the views of industry representatives and understand that they do support this legislation. The bill is due to commence, if passed, on 3 October 2007 and will, therefore, provide protection for those in the industry who have not been able to fulfil the earlier process that was in place. According to the explanatory memorandum, there are no significant financial implications.

We support this legislation because we understand, firstly, that the potential disruption to the supply of medical devices could undermine consumer access to vital devices. This sort of disruption should obviously be avoided if possible. Secondly, we support the bill because it will also ensure certainty of continued supply of such devices in healthcare facilities and help maintain consumer confidence in the system. Finally, we support the bill because it will remove uncertainty within the industry and ensure that the economic viability of the very large Australian medical device industry is not undermined by delays in the new regulatory scheme. I commend the bill to the chamber.

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