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

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.

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