Andrew Southcott (Boothby, Liberal Party, Shadow Parliamentary Secretary for Primary Healthcare) Share this | Hansard source

The Therapeutic Goods Amendment (2010 Measures No. 1) Bill 2010 introduces a number of amendments to the Therapeutic Goods Act 1989. The coalition does not oppose the government’s regulatory reform plan designed to improve the regulation of therapeutic goods in Australia. At present the act covers short-term exemptions for medicines to serve as substitutes for other medicines that are on the Australian Register of Therapeutic Goods but which are unavailable or in short supply and medicines that have no substitute registered in Australia. This bill transfers the same arrangements to medical devices as apply for medicines currently.

Schedule 1 of the bill introduces mirroring provisions for medical devices. The amendments are intended to enable the Secretary to the Department of Health and Ageing to approve the importation and supply of certain medical devices in a number of circumstances. In particular, the amendments enable the secretary to grant approval for the importation and supply of medical devices that are not on the register to act as substitutes for devices that are on the register where these devices are in short supply or unavailable.

The other amendments are largely administrative. These include allowing the secretary to list export-only variations of medicines which are already included on the register; improving the capacity of the TGA to obtain information in relation to medicines; allowing the minister to determine lists of permissible ingredients to be included in medicines; and specifying that persons applying for reconsideration by the minister of an initial decision by the TGA must provide all the information they wish to be considered at the time of application. This bill was previously introduced earlier this year but lapsed with the prorogation of the parliament.

One issue that I should flag is that when the legislation was originally introduced, the Senate Standing Committee for the Scrutiny of Bills expressed concern about the way the bill had been drafted, particularly that proposed subsection 26BB(7), item 3 in schedule 2, provided for incorporating material by reference. The committee did state some concern about that in that it can lead to the ability for a change in obligations to be imposed without reference to the parliament. The committee did seek the minister’s advice about the justification for the way that this bill has been drafted and the opposition will be seeking a response to that. Having said that, we do not see this as a controversial bill. It is essentially about improving the regulation of the therapeutic goods in Australia under the Therapeutic Goods Act 1989. In discussions with stakeholders no concerns were raised about the amendments to this act. It was seen as being a sensible alignment with the way medicines are treated.

The amendments to the act are largely technical or administrative in nature. They do enhance the operation of the act and the efficiency of the TGA. They support Australian companies who wish to export medicines and they improve the TGA’s ability to obtain information from persons who have registered or listed medicines. The legislation also improves the TGA’s ability to obtain information on whether registered or listed medicines have been imported to Australia, supplied in Australia or exported from Australia. It also revises the process in which the minister can reconsider an initial decision by the TGA.

Speaking briefly on the TGA, I believe it is disappointing that the joint regulatory agency, which was planned with New Zealand, will now not be going ahead due to concerns at the New Zealand end, not the Australian end. That is disappointing. We have had a regulatory reform package which originally had in mind a joint regulator between Australia and New Zealand but now it would just be applying to Australia.

This bill will enable the TGA to continue to operate effectively and to keep up with other therapeutic goods regulators around the world and the opposition will not be opposing this legislation.

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