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Thursday, 29 October 2009
Page: 7636

Senator LUDWIG (Special Minister of State and Cabinet Secretary) (3:01 PM) —Senator Fielding on 28 October 2009 asked me a question in relation to the Therapeutic Goods Administration. I seek leave to incorporate the answer in Hansard.

Leave granted.

The answer read as follows—

SENATOR FIELDING asked the Minister representing the Minister for Health and Ageing, upon notice, on 28 October 2009:

I refer to an article in the Age on 22 August 2009 which revealed that an increasing number of unsuspecting Australians are having their mouths filled with cheap dental prosthetics from overseas laboratories which contain toxic heavy metals. Is the minister aware of these serious allegations and what is being done by the government to protect Australians from this dangerous practice?

Isn’t it true that the Therapeutic Goods Administration has banned the use of heavy metals such as lead and nickel in the manufacture of dental prosthetics made in Australia but it is still perfectly legal to import cheap products from overseas that contain these dangerous metals? And don’t these imported dental products end up in the same place as Australian made products—that is, in the patient’s mouth? What is the government going to do to close this dangerous and dodgy loophole?

Given that there is no law to stop dentists using dangerous toxic dental prosthetics from overseas, such as crowns, bridges and dentures, how can it be said that a patient is giving their informed consent when agreeing to have a prosthetic put in their mouth if they do not know what it is made out of or where it was manufactured? Will the government tighten disclosure requirements so that unsuspecting Australians are made aware that their prosthetic may contain dangerous, toxic materials?

SENATOR LUDWIG —The Minister for Health and Ageing has provided the following answer to the honourable senator’s question:

Dental prostheses are regarded as therapeutic goods and are regulated by the Therapeutic Goods Administration (TGA) via a robust international regulatory framework.

However, under this framework some dental prostheses, such as crowns and bridgework prepared for an individual under the direction of a dental professional, are regarded as custom-made medical devices. These products are not required to be included in the Australian Register of Therapeutic Goods.

The TGA is unable to mandate the source of products or materials used by Australian dentists in these devices.

Dentists and others who import such products are, by definition, the ‘sponsors’ of these medical devices and are therefore fully responsible for ensuring the products meet the appropriate standards.

The TGA has worked with the peak dental industry bodies over a number of years to ensure dentists are aware of their responsibilities. However matters relating to professional practice standards are matters for state and territory health authorities.

The TGA has not ‘banned’ the use of heavy metals such as lead and nickel in the manufacture of dental prosthetics made in Australia. Metals such as lead and nickel are invariably present at low levels in dental materials such as porcelain and cannot be completely eliminated.

As a result of discussions with industry associations, the TGA recently initiated a public consultation process in relation to the regulation of custom made medical devices. Comments were invited from all interested parties and the TGA received a number of submissions, including from the professional associations. This work is still under way and the TGA has begun discussions with industry representatives in relation to the comments received to determine the best way to move forward.

Consumers or professionals within the dental industry who have concerns about the quality, safety or performance of specific products are encouraged to report any incidents to the TGA via its Incident Reporting and Investigation Scheme (IRIS). Such reports enable the TGA to investigate and test the materials used in the construction of the devices.

In addition, given the nature of these products it is unlikely that consumers will have an opportunity to review the product labelling. In these circumstances consumers should seek this information from their treating dentist before consenting to undergo any treatment.