Stephen Parry (Tasmania, Liberal Party) Share this | Hansard source

The Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 [2009] amends the Therapeutic Goods Act 1989 in a number of functional ways, introducing a number of clarifications and refinements that have long been foreshadowed. The coalition supports these amendments although we do have some questions of the government to provide some points of clarification. In considering this relatively straightforward legislation we have to remain focused on the need for ongoing reform of the Therapeutic Goods Administration’s processes. The TGA works on a cost recovery basis in order for therapeutic products to be sold in Australia and the goods must be on the Australian Register of Therapeutic Goods. This process is 100 per cent funded through the collection of evaluation fees. The risk of that approach is that the government can be too tempted to impose additional regulatory burdens as it is the applicants intending to bring new products into the Australian market and not the government who have to fund the additional costs incurred.

We are making decisions in this parliament about additional layers but we are not committing additional government resources. We are spending other people’s money; that is why we must be ever vigilant to ensure that the balance is right. That is, the balance between the costs we impose on business and our core objective to maintain high standards in the registration of therapeutic goods. Not to get that balance right could mean that Australia could miss out on potentially beneficial products if relevant businesses decide not to pursue a listing due to excessive costs or long delays. So as we focus on ongoing and future reforms of the Therapeutic Goods Administration processes we must seek to maintain high standards while lowering the cost of compliance.

Feedback from industry stakeholders is that they support the current bill. However, the industry also pointed out that the current reforms are relatively minor and that further reform, including a recommitment to negotiations towards an Australian-New Zealand regulatory regime, is required. For example, the Australian Self Medication Industry described the current legislation as ‘a bit of tidying up at the margins’ and called for a renewed push to world’s best practice reform of the TGA. We certainly urge the Australian government to pick up where the Howard government left off in working with the new government in New Zealand to take up this reform.

Following a memorandum of understanding between the two governments in December 2003, negotiations to create the Australia New Zealand Therapeutic Products Authority commenced. I know Senator McLucas, the then responsible shadow, is on the record supporting the revival of negotiations on ANZTPA and I would hope that, regardless of the current legislation, the joint regulatory process will be revived as soon as possible. Industry is particularly keen to have the reform agenda restarted. In the process of reviewing this legislation with a range of industry bodies it was clear that whilst the current reforms are welcomed—in fact seen as overdue—more reform is required. So in speaking on this legislation I ask that the government gets on with the job to ensure that the stalled reform process is restarted as soon as possible.

As I have already advised the Senate, the coalition supports these amendments. These amendments, in brief, seek to achieve the following: exempt medical devices from the operation of the act to allow for stockpiling and rapid availability in emergency situations and to declare these exemptions as not legislative instruments and therefore not disallowable, tighten the fit and proper person test for manufacturing licences and medical device conformity assessment certificates, adopt the European and United States pharmacopoeias in addition to the British Pharmacopoeia as default standards under the act, improve access to information from the TGA, clarify the regulation of advertising of therapeutic goods, and align criminal penalty provisions with current policy. These are largely technical amendments designed to enhance the operation of the TGA.

The one area where the coalition would like some further information from the government is that of exemptions for medical devices that are required in an emergency, or that need to be stockpiled for a potential emergency, which can be granted by the minister. Clearly, this is an important provision and is required only because previous amendments to the Therapeutic Goods Act distinguish between medical devices and other therapeutic goods without giving medical devices access to the exemption provisions already in the act.

However, in seeking to clean up this anomaly, the government is proposing to go further. We would simply like to more clearly understand why. Unlike the current exemption, the government appears to be intent on making those exemptions not disallowable—that is, removing all oversight from the process of this parliament. When the government seeks to create an instrument that cannot be disallowed, it has an obligation to clearly set out the reasons why this is necessary. To date, the best we have got from the government is a reference to national security. We would like that explanation to be expanded upon. We will be looking for more adequate explanation from the government at the conclusion of the second reading debate. We understand from our discussions with the government that such an explanation will be forthcoming, and we appreciate that. The opposition shares the view of the Senate Standing Committee for the Scrutiny of Bills that there is a need for a more full explanation of what the intent is and why it is required. As I have said, the TGA is a fundamental part of Australia’s health regulation. It will need continual refinement to operate most effectively. I again urge the government to act and have a joint regulatory initiative with New Zealand, which was commenced under the Howard government. I again place on record that we do support the bill.