Thursday, 16 August 2007
Therapeutic Goods Amendment Bill 2007
I present the explanatory memorandum to this bill and move:
That this bill be now read a second time.
I am pleased to introduce the Therapeutic Goods Amendment Bill 2007. The amendments provided for in this bill are necessary to allow many devices currently marketed in Australia that are essential for patient treatment and for the ongoing provision of healthcare services to be supplied beyond 4 October this year whilst under reassessment by the Therapeutic Goods Administration.
The amendments provided for by this bill provide great certainty for patients, for healthcare providers and for the medical device industry in Australia. In 2002, the government introduced a new regulatory system for medical devices which allowed a five-year transition period, ending on 4 October this year, for previously marketed devices to comply with new legislative requirements. These requirements are based on principles developed by the Global Harmonisation Task Force for Medical Devices, which comprises regulators and industry representatives from Europe, the United States of America, Canada, Japan and Australia. Under the existing terms of the transition period, sponsors who wish to continue to supply previously registered and listed therapeutic devices after 4 October 2007 are required to have their products re-entered in the Australian Register of Therapeutic Goods as ‘included medical devices’ following assessment against the new legislative requirements by the TGA by 4 October this year.
The framework introduced by the government was and continues to be at the vanguard of medical device regulation globally. The framework is one that is in line with international best practice and ensures that products newly available to the Australian community comply with current internationally accepted requirements. However, when the scheme was introduced it was estimated that in excess of 30,000 devices would need to make the transition to the new scheme and consequently require reassessment by the Therapeutic Goods Administration. This has posed significant challenges for both the medical device industry and the TGA to ensure there is continued supply of vital medical devices after October 2007.
A belated influx of applications and the likelihood of further last-minute applications means the TGA may not be able to complete its assessment of all outstanding transition applications in time for the 4 October 2007 deadline. Many sponsors who have submitted applications to transition their products are now faced with uncertainty about whether they will be able to continue to supply those products after 4 October 2007. Similarly, purchasers and end users of devices are faced with uncertainty about continued access to transitioning products. Disruption to the supply of medical devices due to failure to transition by 4 October this year could have a significant impact on consumer access to vital medical devices, the supply of medical devices to healthcare facilities, the operation of healthcare facilities, consumer confidence in the health system as well as the economic viability of Australian medical device companies.
The amendment provided by this bill substitutes the existing requirement for medical device sponsors to have their products entered in 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. Under these amendments, sponsors and end users of medical devices will have certainty of continued supply and access because it will depend solely on the sponsors submitting an effective and successful application to have their product transitioned by 4 October 2007.
The government places a high priority on the availability of and access to important treatments by Australians and the presence of a strong, vibrant medical devices industry in its therapeutic policy planning. This new amendment is an important part of that planning, for it allows for continued access to important treatments by Australian consumers and healthcare providers whilst ultimately ensuring that all medical devices available in Australia comply with current internationally accepted requirements.
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.
I would like to make a quick comment on the Therapeutic Goods Amendment Bill 2007. The bill before us today—as the shadow minister and the Parliamentary Secretary to the Minister for Transport and Regional Services have stated—amends the Therapeutic Goods Act 1989. It effectively extends the transition period presently ending on 4 October 2007 to enable therapeutic devices currently listed or registered on the Australian Register of Therapeutic Goods under an old regulatory scheme to be entered in the ARTG as a medical device under the new regulatory scheme introduced by the government. Labor, as the shadow minister has already stated, support this legislation—particularly because we do not want any potential disruption to the supply of medical devices, which could have a significant impact on the supply of medical devices to healthcare facilities and on consumers’ access to vital medical devices. With those few words, I will end my comments.
in reply—I acknowledge the contribution of the shadow minister for health on the bill. Because the opposition cannot organise themselves in opposition—let alone hoping to organise themselves in government—we had additional comments from the member for Shortland, and I welcome them. The amendments provided for in this bill are necessary to allow many devices currently marketed in Australia that are essential for patient treatment and for the ongoing provision of healthcare services to be supplied beyond 4 October this year. Under the existing provisions in the Therapeutic Goods Act 1989, registered and listed therapeutic devices that have not been assessed against new legislative requirements introduced in 2002 and entered in the Australian Register of Therapeutic Goods, the register, as ‘included medical devices’ by 4 October this year can no longer be supplied commercially in Australia. The amendment provided for by this bill substitutes the requirement for medical device sponsors to have their products entered in the register as ‘included medical devices’ by 4 October this year with the requirement to lodge an effective application with the Therapeutic Goods Administration with the intention of transitioning their products to the new regulatory scheme by that date.
The scope of the amendment covers two broad situations. The first is where an application for inclusion of the device in the register has been lodged with the TGA. The second is where an application must first be made to the TGA for its certification of a product’s compliance with quality, safety and performance requirements set out in the legislation. This second situation has been covered because of the importance of this certification as a prerequisite to a valid application for inclusion in the register for devices specifically identified in the Therapeutic Goods (Medical Devices) Regulations 2002. Without this bill, the cancellation of the entries in the register will affect not only those products that sponsors do not intend to transition to the new regulatory scheme but also products that are the subject of an effective application undergoing review by the TGA but not completed at the time the transition period ends on 4 October.
The consequence of cancellation of the latter group of devices from the register will be a hiatus in commercial supply of those devices leading to commercial disadvantage for the sponsor and an interruption of access by patients and their practitioners to important healthcare services and treatments. Under these amendments sponsors, practitioners and their patients, and healthcare providers will have certainty of continued supply of medical devices while the TGA completes its assessment to ensure the devices comply with the current internationally accepted standards. I commend the bill to the House.
Question agreed to.
Bill read a second time.
Ordered that this bill be reported to the House without amendment.