Mr STEPHEN SMITH (10:12 AM) —On the basis of the cognate debate, there are three bills for consideration: the Therapeutic Goods Amendment Bill (No. 1) 2002, the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Charges) Amendment Bill 2002, which is linked to the medical devices legislation. The opposition has no objection to the cognate debate and no objections to the bills themselves, which we will support, although I will make some remarks in respect of two of the bills and give notice that in the Senate we will be formally moving an amendment to one of the bills.

So far as the Therapeutic Goods Amendment Bill (No. 1) 2002 is concerned, if Australia were subject to a chemical, biological or radiological attack or emergency, a response might require rapid access to large amounts of vaccines, antibiotics or chemical antibiotics that may not have been approved through the normal therapeutic goods approval processes. This bill seeks to allow the Minister for Health and Ageing to authorise the importation, manufacture or supply of unapproved therapeutic goods that are essential to public health should Australia be subject to a CBR—chemical, biological or radiological—attack or emergency and to permit the stockpiling of such goods.

The bill proposes that the minister can only grant exemptions in relation to these goods in exceptional circumstances: in the national interest or in the face of a potential or actual threat to public health. Each exemption granted under the act must specify the period, quantity, source, storage, record keeping and conditions of supply of those goods. The minister is required to publish the exemption in the Gazette within five working days and to table the exemption in the parliament within five sitting days. The exemptions gazetted and tabled are not required to contain information such as the location of the stockpile, which might be prejudicial to the national interest.

On that basis, the opposition supports the bill. However, the bill does not make the exemptions to which I have referred disallowable, and I give notice that the opposition proposes to move amendments in the Senate to make the exemptions disallowable. As the powers granted to the minister by the bill are powers to override existing safeguards, it is appropriate that parliament have the opportunity to fully question and, if necessary, overturn those exemptions. Subject to the moving of that amendment, the opposition supports the Therapeutic Goods Amendment Bill (No. 1) 2002.

So far as the Therapeutic Goods Amendment (Medical Devices) Bill 2002 is concerned, medical devices are of course increasingly important in supporting and saving lives and enabling people to live normal lifestyles. The level of regulatory scrutiny has not necessarily been commensurate with the level of technological sophistication involved. This legislation helps address the situation and seeks to bring Australia in line with international best practice, and on that basis the opposition commends the legislation and supports it.

This legislation seeks to modernise the system of regulation of medical devices in Australia to make it consistent with new international best practice and best standards. Medical devices range from examination gloves and compression hosiery to heart valves and pacemakers. All such devices are regulated by the Therapeutic Goods Administration, the TGA, to ensure safety. Currently, devices are either listed as low risk or registered as high risk. The new system will create a five-tiered classification system and apply more appropriately graded regulatory requirements to each classification. A device will be classified according to the degree of risk involved in its use based on its invasiveness, the duration of its use, the location and whether or not the device is powered.

The new system adopts a global regulatory model developed by the Global Harmonisation Task Force, which comprises the world's key device regulators and peak industry bodies such as the United States of America, Canada, Europe, Japan and Australia. As Australia imports 90 per cent of medical devices used in Australia—and our medical device exports make up one per cent of the world market—it is in our national interest to be internationally aligned.

The TGA is a cost-recovery organisation. The Therapeutic Goods (Charges) Amendment Bill 2002—the second of the two bills considered in this context—makes consequential amendments to ensure that the ability to levy fees on applicants is not affected by the restructuring of the register. It is important to acknowledge the increased level of resources that will be necessary to effectively implement this legislation. Resources will be needed to reassess and reclassify devices already on the market in a timely fashion, to assess new devices entering the market, to develop standards and quality control procedures for manufacture, to establish safety and efficacy, to manage the reporting of adverse incidents and to ensure appropriate staff training in skills. The user fee system which applies is intended to support and effect this, but in my view regular assessment will be needed to ensure there are no impediments to the effective functioning of the regulatory system and the ability of this system to protect the Australian people and to vitalise Australia's medical device industry.

There is one aspect of the legislation which is of concern to the opposition. The legislation includes a provision to allow for the tracking of high-risk implantable devices. Although the government argues that processes are in place to establish a comprehensive tracking system for such devices, action in this area is, in my view, not progressing quickly enough, and that point needs to be underlined so far as the opposition is concerned. Indeed, members may be aware that legislation precisely along these lines was introduced into the previous parliament but lapsed on the calling of the 10 November election. During the progress of that legislation in the previous parliament, the opposition formally moved amendments to seek to establish a register of implantable devices. That was in the context of adverse public commentary on the defective St Jude heart pacemakers, which came to public attention in the year 2000. In August 2001 defects became the subject of public commentary—for example, French made ceramic hip replacements. In the course of that parliament, the government did not take up the opposition's suggested amendment to formally establish a register of high-risk implantable devices.

At officer level there has been discussion about this proposal again, and it is clear to me that the government is not proposing to take up such an amendment. On that basis, the opposition will not be wasting the time of the House, or the Senate, to so move. I do underline our concern in this area. In the government's remarks in closing this debate, I look forward to hearing an outline of the processes which the government has embarked upon to deal with this sensitive and contentious area. On the basis of formally giving notice of an amendment, which we propose to move in the Senate, and underlining the opposition's concern in respect of the high-risk implantable devices, the opposition supports the three pieces of legislation and commends them to the House.