Mr LEE(10.03 a.m.) —The opposition will be supporting the Therapeutic Goods Amendment Bill 1997. We thank the Minister for Family Services (Mrs Moylan) for the detail contained in the second reading speech.

Firstly, the legislation allows for the implementation of a mutual recognition agreement in relation to safety standard checks for medical devices. As the minister has outlined, it will allow for the acceptance of devices manufactured and certified in the European Union without further testing in Australia. However, I understand from the minister's second reading speech that this certification will have to ensure that these devices meet with all Australian regulatory requirements relating to good quality, safety and efficacy, and that listable devices specified in the certificates meet with all requirements as to good quality and safety. I hope I have understood that correctly.

We also understand that this agreement will only apply to therapeutic devices of a reasonably straightforward and non-complex nature and that other devices, such as pacemakers and other high-tech critical devices, will still be subject to testing in Australia. On that basis, this seems like a sensible streamlining of arrangements, as far as the opposition is concerned, and one that will help to ensure a timely supply of these therapeutic devices to Australians who need them.

The second intention of the legislation is to allow for the withdrawal of batches of drugs where only minor problems have occurred and where the manufacturer has a good record, rather than enforcing the alternative, that is, requiring the entire de-listing of a drug should problems occur. I understand from material provided in the Senate by the Parliamentary Secretary to the Minister for Health and Family Services, Senator Ellison, that while the government currently has a mechanism under the Trade Practices Act to require a batch to be withdrawn, there is no provision under the Therapeutic Goods Act for a single batch to be withdrawn. Rather than relying on the existing power in the Trade Practices Act, this ensures that the TGA can take action individually. That seems like a sensible improvement and one which the opposition is willing to support, along with the other proposals contained in the legislation.