Jan McLucas (Queensland, Australian Labor Party, Shadow Minister for Ageing, Disabilities and Carers) Share this | Link to this | Hansard source

Given the hour, I seek leave to have my speech on the second reading of the Therapeutic Goods Amendment Bill 2007 incorporated in Hansard.

Leave granted.

The speech read as follows—

I rise to speak on the Therapeutic Goods Amendment Bill 2007.

The purpose of the Bill is to amend the Therapeutic Goods Act 1989 to effectively extend the transition period enabling “therapeutic” devices currently “listed” or “registered” in the Australian Register of Therapeutic Goods (ARTG), 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 the Therapeutic Goods Amendment Act (No. 1) 2006 and the Therapeutic Goods Amendment (Medical Devices) Act 2002.

Labor will be supporting the passage of the Bill through the parliament.

By way of background—the Australian Register of Therapeutic Goods (ARTG) is a computer database of therapeutic goods, established under the Therapeutic Goods Act 1989 and administered by the Therapeutic Goods Administration (TGA).

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” in the ARTG under the old regulatory scheme, set out in Chapter 3 of the Act, to be entered in the ARTG as “medical” devices under the new scheme (Chapter 4 of the Act) by either 4 October 2004 or 4 October 2007.

The first transition period, established through the operation of subsections 9B(1), 15A(5) and 15A(6) of the Act, ended on 4 October 2004 and 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 in the ARTG.

The second transition period, established in subsection 9B(2) of the Act, ends on 4 October 2007. The effect of current subsection 9B(2) is that therapeutic devices “registered’ or ‘listed’ in the ARTG under Chapter 3 of the Act will be taken to have been cancelled on 4 October 2007 or, if entered in 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 of the Act is to prevent the sponsor of those therapeutic devices from continuing 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 the new regulatory scheme necessitated that more than 30,000 “medical” devices be re-assessed 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 re-assessment 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 re-assessments will be completed by the 4 October 2007 transition deadline.

The amendments in this Bill seek to effectively extend the transition period. The 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 a 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—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 has sought views from industry representatives and understands that they support this legislation.

The Bill commences, or is taken to have commenced, on 3 October 2007.

According to the Explanatory Memorandum there are no significant financial implications.

Labor supports this legislation because we understand, firstly, that the potential disruption to the supply of medical devices could undermine consumer access to vital medical devices, and this sort of disruption should obviously be avoided.

Secondly, Labor supports the Bill because it will also ensure certainty of continued supply of such devices in health care facilities and help maintain consumer confidence in the health system.

Finally, Labor supports the amendments because they will remove uncertainty within the industry and ensure that the economic viability of Australian medical device companies is not undermined by the delays in the new regulatory scheme.

In conclusion, as I said at the outset, Labor will be supporting the Bill.

Brett Mason (Queensland, Liberal Party, Parliamentary Secretary to the Minister for Health and Ageing) Share this | Link to this | Hansard source

I commend the bill to the Senate.

Question agreed to.

Bill read a second time.