De-Anne Kelly (Dawson, National Party, Parliamentary Secretary to the Minister for Transport and Regional Services) Share this | Hansard source

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.

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