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Thursday, 30 September 2010
Page: 283

Ms KING (Parliamentary Secretary for Health and Ageing and Parliamentary Secretary for Infrastructure and Transport) (10:30 AM) —I move:

That this bill be now read a second time.

This bill makes a number of amendments to improve the regulation of therapeutic goods in Australia under the Therapeutic Goods Act 1989.

The government is committed to maintaining the position of Australia’s Therapeutic Goods Administration as a leading global regulator of therapeutic goods.

This means we need to update the legislation under which the TGA works, to meet emerging issues and ensure that the act gives the regulator the necessary powers to exercise its functions fairly and effectively.

This is the fifth in a series of amendment bills since 2008 to make much needed improvements to the act. As a government we have now disposed of the backlog of amendments to the act that had been stockpiled in the lead-up to the introduction of the now postponed joint regulatory agency with New Zealand.

Schedule 1 of this bill will introduce measures allowing for the short-term exemption from the act of medical devices to serve as substitutes for devices that are registered by the TGA but are unavailable or in short supply, and medical devices that have no substitute registered in Australia. These provisions mirror those already included in the act at section 19A in relation to medicines.

The existing section 19A provision is widely used to deal with disruptions to the availability in Australia of important medicines caused by supply chain problems, such as refurbishment of manufacturing facilities. While the unavailability of medical devices under such circumstances has not been a major problem in Australia, the government believes that including a similar provision in the act will allow appropriate flexibility in the medical device regulatory framework.

Under the proposed amendments the secretary may grant a person approval to import, or import and supply, a device to act as a substitute for a registered device if the device is marketed in a country specified in the regulations or if an application has been made to register the device in Australia and the secretary considers the approval is in the interests of public health.

If the application is to import, or import and supply, a device where there is no substitute registered in Australia, the secretary may grant the approval only if an application has been made to register the device in Australia and the secretary considers the approval is in the interests of public health.

These provisions do not take away the ability of a doctor to supply an unapproved medical device in an emergency situation. Rather, they operate to deal in a systematic way with the unavailability of approved medical devices. Other amendments allow the secretary to gather information on the supply and use of devices covered by an approval and allow for the recall of the devices under certain circumstances.

The schedule also contains consequential amendments to the offence provisions related to medical devices.

Schedule 2 of the bill includes a range of amendments to various provisions in the act.

One of the more significant will include an explicit pathway for sponsors of medicines already registered or listed by the TGA to list an export-only variant of the medicine. Although section 26 currently allows medicines to be listed for export, there is no link between these medicines and a medicine already on the register.

The new provision will allow the secretary to list a variation of an existing medicine as long as the variant differs from the existing medicine only in respect of characteristics specified in a legislative instrument. The government intends that these characteristics will be colourings, flavourings and excipients.

This provision will support Australian companies wishing to export medicines by allowing them to state to authorities in the importing country that the medicines are a minor variation on a medicine available on the Australian domestic market and to point to the provision in the act that allows the listing of such variants.

Another group of amendments in the schedule improve the TGA’s ability to obtain information from persons who have registered or listed medicines.

The act already includes powers for the TGA to obtain information on a wide range of subjects. However, while the secretary’s delegates in the TGA can impose conditions on the registration or listing of medicines, there is no explicit power for the TGA to obtain information relating to compliance with these conditions. The amendments include such a power.

The amendments also add a power for the TGA to obtain information on whether registered or listed medicines have been imported into or supplied in Australia, or exported from Australia. While this information can be very important in assessing the risk arising from an identified deficiency with a medicine, sponsors have in the past refused to provide it. These amendments put beyond doubt the TGA’s ability to obtain that information.

The schedule also amends the provisions relating to reconsideration by the minister of initial decisions by the secretary and her delegates in the TGA. Under the current provisions persons affected by an initial decision may apply to the minister for reconsideration within 90 days of the decision, and the minister must then reach a decision on the reconsideration within 60 days.

It is not uncommon for persons to apply for reconsideration but not supply any supporting information at that time. They then supply additional information well into the 60-day period during which the minister must reconsider the decision. Indeed, there is nothing to prevent the provision of additional information on day 59.

The amendments to section 60 address this by requiring persons applying for reconsideration to submit at the time they apply any information they wish the minister to consider. The amendments then preclude the minister from considering any further information provided by the person seeking reconsideration, unless it is information provided in response to a request by the minister or information indicating that the quality, safety or efficacy of the therapeutic goods involved is unacceptable.

These amendments will ensure that reconsideration by the minister is based on a deliberate analysis of all the relevant information, and avoid the need for hasty review of information supplied at the last minute.

The schedule also amends the provisions allowing the minister to determine lists of permitted ingredients to be included in medicines. These amendments are essentially technical changes to improve the workability of the provisions by allowing the list of permitted ingredients to include ingredients with restrictions or conditions on them.

Finally, the schedule clarifies that where a medical device is required to be audited before it can be approved the assessment fee for this audit is to be payable in accordance with the act or the regulations. This will ensure that all applicants pay the appropriate fee.

Together with the earlier regulatory reforms introduced by the government, this bill ensures that the TGA can continue to operate effectively as one of the leading therapeutic goods regulators in the world.

Debate (on motion by Mr Turnbull) adjourned.