Senate debates

Thursday, 19 March 2009

Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 [2009]

In Committee

4:34 pm

Photo of Ursula StephensUrsula Stephens (NSW, Australian Labor Party, Parliamentary Secretary Assisting the Prime Minister for Social Inclusion) Share this | Hansard source

Can I indicate to Senator Siewert in fairness that the government does not support the amendment. Firstly, we need to remember that these exemptions are not legislative instruments and never ought to have been disallowable. They do not state the law generally or modify the law generally; they are really in the nature of permits, and permits are not as a rule visible to parliament, far less subject to parliamentary scrutiny or disallowance. Currently under section 19 of the act the secretary may approve the importation of unregistered medicines for use in clinical trials or for the treatment of particular individuals. Under section 19 the secretary may approve the importation of unregistered medicines to replace medicines that are on the register but in short supply, as long as a person has applied to have the replacement medicine registered in Australia or they have been registered in another country. These approvals, which result in the immediate supply of unregistered medicines to people in Australia, are not appropriately subject to any parliamentary reporting or oversight.

Secondly, the government has been advised that these exemptions should be kept confidential for reasons of national security. Making them available automatically to a committee of each house will unnecessarily broaden the number of people who will have access to the information without any countervailing benefit.

Thirdly, Senator Siewert’s amendment does not seem to be very workable, especially as far as proposed subsection (5) is concerned. I do not see how a committee could refer to information about exemptions in a report to parliament without actually revealing the substance of those exemptions, and I do not see how useful that could be.

Finally, establishing a committee of each house for this purpose with biannual reporting could be a very heavy-handed approach given that most of the time there would be nothing to report. So, while I understand the principle you are pursuing, its application in the circumstances is inappropriate.

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