Jan McLucas (Queensland, Australian Labor Party, Shadow Minister for Mental Health) Share this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013. This bill is in large part a reintroduction of a bill listed in the last parliament, so of course we will be supporting the bill, but I do need to make some comments about two areas where this bill does differ from the bill that was introduced by our government.

The first issue goes to the question of up-classification and it responds to a particular event where we needed to move therapeutic goods from class IIb to the higher risk category of class III. It was a process started by our government and it follows the 2011 Senate Community Affairs Committee of inquiry that reported to the parliament.

The purpose of this amendment and how it differs from the original bill as introduced in the last parliament is to extend the transition period to allow medical devices to stay on the register for the period of time providing the application for the up-classification element is lodged by, I think, 30 June—by the date that was indicated earlier. It is our view that, while it would have been preferable for the processes to have concluded in that time, we believe this is a sensible response from the government and therefore it will be supported by the opposition.

But it is in the second area of difference between the two pieces of legislation where the Labor Party is, I have to say, very disappointed. It goes to schedule 14 in the original bill. Schedule 14 in the original bill was framed in order to improve the scope and the flexibility of the secretary's powers when it comes to ensuring the proper communication of health risks or concerns and, in some cases, the issuing of recalls in relation to goods, biologicals and medical devices. It was a sensible amendment that we proposed, but unfortunately it does not appear in this piece of legislation.

It was designed to ensure that the sponsors of medicines, biologicals or medical devices that are subsequently found not to be as expected can provide appropriate information to the secretary of the department. Further, in the case of medical devices the original schedule added the capacity to require the publication of specified information, a capacity that already exists in relation to the therapeutic goods and biologicals. But most importantly of all, the proposed amendment would have enabled the secretary of the department to require from the sponsor of a therapeutic good, biological or medical device the details of those who have received or have been treated with a particular product.

There are practical reasons why it is a good idea for the secretary to have the power to be able to require the sponsor of a therapeutic good, a biological or a medical device to provide them with the details of who has received that product. We have had two major events happen in recent years. In 2010 and 2011 we had the issue of the faulty hip device that we identified as being transplanted into people, but fortunately here in Australia we have the National Joint Replacement Registry. It had details of who had had the device implanted. But that is not available or recorded as a matter of course for other medical devices that are being implanted, so when we saw the event of recent years where the fraudulent substitution of a form of silicon in breast implants had been implanted into Australian women, it raised serious questions for those women and their families. But we did not have a register of who had had this product implanted.

It is essential, we believe, that we have the regulatory capacity to require the details of those affected so that the imperative of ensuring that Australian health consumers are contacted and informed about issues that could have a serious impact on their health is not left in the hands of the product sponsor alone. This is a public health issue, and one we believe has the support of the community, so we are disappointed that the government has not agreed with our amendment in the House of Representatives. But given that the other elements of this bill are necessary, and some are time sensitive, we do encourage the government to maintain a watching brief on the need for a schedule 14, as we will. And that being said, I can indicate the opposition's support for the bill.