Peter Dutton (Dickson, Liberal Party, Minister for Health) Share this | Link to this | Hansard source

Can I start by thanking the member for Fremantle for her contribution. I know that she is sincere in her approach to what is a very serious issue, particularly for those patients whom she quite rightly identified as having had difficulty around implants or other issues, and the government is very sensitive to those particular issues and keen to try to strike a balance.

But we do believe that the opposition has gone too far in terms of that which they seek from the amendments to sections 30EA, 32HA and 41KA of the Therapeutic Goods Act. The government does not believe that the amendments are necessary and believes that they do have the definite potential to add to regulatory burden in the absence of a demonstrated need.

By way of background, the TGA can mandate the recall of therapeutic goods in particular circumstances. For instance, if the product does not comply with applicable standards, the product is supplied without approval—that is, when it is not included in the Australian Register of Therapeutic Goods, as required, or when the safety, quality or efficacy of the goods is unacceptable. The TGA can currently cancel products from the register where there are safety issues. The sponsor of the product can then no longer supply the product. The sections that were proposed to be amended relate to the TGA's powers to take action to recall products already in the market and to provide information to the public about those products. In circumstances where the TGA can, under existing provisions, mandate a recall, the TGA can currently require the sponsor of the goods to provide to the public information that those circumstances—for example, the quality of the goods is unacceptable—exist. Moreover, the TGA can, in the case of medicines or biologicals, require the sponsor to publish information about the manufacture or supply of those goods. The amendments would have allowed the TGA to require the sponsor to provide to the public directly more information about the circumstances giving rise to a right to recall—for example, a cancellation—and to provide to the TGA information about persons to whom the goods have been supplied.

The removal of these amendments does not represent a risk to the public. The TGA can already require a sponsor to provide information about the safety of a product in matters relating to supply. The TGA can also publish information on its website about the safe use of therapeutic goods and other regulatory decisions made under the act, such as decisions to cancel a product from the register. The TGA is also able to provide information to health-care professionals about the status of therapeutic goods and their safe use. The amendments would have meant that this information could be required to be published by the sponsor or provided by the sponsor directly to a class of persons, such as health-care professionals. In other words, the effect of the amendments was to require the sponsor, rather than the TGA, to make this information available. The government does not believe that, in the absence of a demonstrated need, statutory obligations should be placed on industry. The government is, of course, at liberty to revisit this matter should circumstances change.

There are no restrictions on the TGA publishing such information on its website, which is where the public of course may expect to find it. The TGA now provides comprehensive information on its website about all recalls of therapeutic goods. It also publishes information in the form of hazard alerts about medical devices in relation to which safety issues have arisen. The amendments were not prompted by any particular practical issues experienced by the TGA with sponsors not volunteering information about persons to whom products had been supplied.

I will finish on this final note, which goes not to the member for Fremantle's contribution but to the position of the opposition when in government, because their significant record—perhaps their most outstanding record from a Labor perspective—is that they introduced almost 21,000 regulations but only repealed 104.

It is the case that under Labor, business was burdened with new taxes and regulations without due consideration of the impact. The coalition's priority is to build a stronger more productive and diverse economy through more efficient government and more productive businesses that will deliver more jobs, higher wages and better services for all Australians. The government's deregulation agenda is absolutely central to this cause. On that basis we oppose the amendments.