Thursday, 18 June 2020
Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020; Second Reading
Labor support the Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020 because we support Australians having access to medicines and therapeutic devices in a timely, affordable and, importantly, safe way. I commend the bill to the Senate.
I thank Senator Dodson for that contribution and for the opposition's support for the bill. It was thoroughly well thought through, very well researched and delivered with passion, can I say, Senator Dodson! But being to the point and succinct is also welcome in this chamber, so I commend Senator Dodson and the Labor Party for their contribution to this debate. This is an important debate and it is, as Senator Dodson says, something that we must progress. So it is my pleasure indeed to make a contribution to the debate on the Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020.
This bill amends the Therapeutic Goods Act to implement a range of measures to support the health and wellbeing of Australians, something that I'm sure not a single senator in this place doesn't agree with being a priority. It is something we are all passionate about. In particular, this bill introduces measures to improve access to therapeutic goods for Australians, encourage innovation, reduce the regulatory burden and enhance patient safety through removing a barrier to efforts to alleviate medicine shortages—all very, very important measures and something that I'm sure, as Senator Dodson summed up so succinctly, we all support in this place.
In relation to improving access to therapeutic goods, the bill amends a number of medical device definitions to more closely align Australia's regulatory framework for devices with the European Union framework, which I think is a great outcome, as most devices supplied in Australia are manufactured overseas. I mentioned innovation in my opening remarks. I would love to see change; I would love to see more innovation in the med-tech sector and see more of this happening onshore here in Australia, where we can support young Australians who want to work in this industry. Through the innovation that this bill will support, we will see more of that. As I say, given that most devices that are supplied in Australia are manufactured overseas, by reducing the differences between these two frameworks, the EU and Australia, we're going to minimise delays in device sponsors and manufacturers seeking marketing approval in Australia after they've received their European approvals. That streamlining, that removal of red tape, is something that I know the sector will welcome. I know that those who work here in the sector—and indeed those who work on behalf of European companies—would also welcome that streamlining and removal of red tape.
The bill we're debating right now enables the secretary to provide early scientific advice to sponsors of registrable medicines, mainly prescription and over-the-counter medicines, about prescribed aspects of the medicine's safety, quality or efficacy, to assist sponsors to better understand the level and nature of information needed to support a successful application for marketing approval. It goes to patient safety and, indeed, ensuring that there is integrity in our pharmaceutical industry and the delivery of medicines to those who need them most—and I will commend the Morrison government for all the work that has been put into adding medicines to the Pharmaceutical Benefits Scheme. Through the sound economic management of the Treasurer, Josh Frydenberg, and the Minister for Finance, Senator Cormann, we can afford to put medicines on the PBS, many of which would be covered, I imagine, under what we're talking about here. Providing safety, but, above all, providing access to medicine, is something that this government is very proud of and that this bill supports our capacity to do.
This measure will reduce delays in access to new medicines that stem from industry uncertainty about aspects of supporting information for such products, particularly for generic medicines in relation to bioequivalence studies, and the advice will guide sponsors and help them to reduce the incidence of rejections and the time and cost of developing evidence that is not needed. That is something that will reduce burden and unnecessary work in the regulatory space.
The bill also removes a barrier for promising new medicines to access the new provisional registration pathway which was introduced in 2018 to provide access to medicines that provide a major therapeutic advance over existing treatment options for very serious conditions. Other measures in the bill address issues of delay and interruption for the operators of clinical trials who need to make variations to the terms of their approvals; improve flexibility for authorised prescribers seeking to supply unapproved therapeutic goods to their patients; and encourage innovation—again, a very important point—and investment through the introduction of targeted data protection regimes for clinical trial data for assessed, listed medicines. The bill also enhances patient safety by removing a criminal offence that has been the subject of concerns that it may be a disincentive to sponsors of potential alternative products to a medicine that is in shortage from identifying if they were able to arrange for the supply of their products to help alleviate the effects of the shortage.
I thank senators for their contributions to the debate on this bill. In particular, I thank Senator Dodson for his very well thought through, well researched and passionate contribution—in particular, noting the importance of innovation and investment, providing certainty to this industry and so to the many thousands of Australians who work in it—people who actually want to make a difference in the lives of Australians who benefit from medical technologies and from medicines. The streamlining and speed with which the secretary is going to be able to provide that is important. Given we are about to go to the second reading vote, I just really want to highlight how big a supporter the Morrison government is of ensuring that more of this happens onshore in Australia. While working with our partners in Europe and elsewhere, we want to make sure more of this happens here. A lot of this will go to that. So, again, in thanking Senator Dodson for his impassioned contribution, I commend this bill to the Senate.
Question agreed to.
Bill read a second time.