Anne Ruston (SA, Liberal Party, Shadow Minister for Health and Aged Care) Share this | Link to this | Hansard source

STON (—) (): I'm pleased to be able to stand today to make a contribution in relation to the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022. This bill amends the Therapeutic Goods Act 1989 to implement a number of measures that seek to ensure continued access to critical prescription medicines. We will be supporting this bill in recognition that it continues the work of the coalition and our very strong commitment to ensuring affordable medicines for all Australians and strengthening our world-class health system, of which Australians are rightly very, very proud. This bill will also support the safe use of therapeutic goods by strengthening post-market monitoring and compliance.

The need to safeguard patient safety and ensure the early detection of adverse events related to medical devices was emphasised as long ago as during the 2017 Senate inquiry. It is absolutely imperative that, whenever we put legislation through this place, first and foremost, we put the safety of patients at the forefront of all of our decision-making. In 2017, the Senate inquiry followed an investigation of medical devices that were developed in the late 1990s which had later reported widespread complications with patients. We heard Senator Steele-John before refer to a particular incident and inquiry in relation to the adverse impacts of a particular device that had absolutely devastating and quite widespread consequences for the women who were implanted with that device. But, from that inquiry, recommendation 1 noted that adverse event reporting plays a vital role in a post-market surveillance and proposed a mandatory reporting scheme by health practitioners to prioritise health safety. It is obviously very important that we continue that work.

Consequently, this bill introduces a framework for mandatory reporting requirements of adverse event information by hospitals, supporting improved monitoring, early detection and timely action to safeguard patients from harm. There were a number of other recommendations that were included in that report, many of which I hope over time that the government will have a look at implementing. As I said, we're very happy to support this important piece of reform legislation, which is absolutely putting patient safety at the centre of its intention.

The bill will also make a number of amendments to improve requirements, codify current practices and remove certain provisions from the legislation. The bill will also introduce a dedicated marketing approval pathway for 'export only' biologicals to support the important export market for Australians. I don't know that many Australians actually realise how huge the export market is or the kind of respect that Australian biologicals have in the international marketplace. This bill will ensure that we have a system that allows our fantastic Australian based manufacturers to be able to get easy access to a world market so that they can continue to provide world's best practice when it comes to these particular products.

It will also enable the Department of Health and Aged Care to approve the importation of overseas prescription medicines that are substitutes for medicines which have previously been approved in Australia, assisting to relieve supply shortages. Sadly, at the moment, we have significant supply shortages, particularly for medicines, so this seeks to remedy against that.

The coalition absolutely supports the intention of this bill to ensure continued access to potentially life-saving and life-changing and life-improving medicines for Australian patients. However, more can and must be done to safeguard accessibility to critical health care for Australian households currently facing significant cost-of-living pressures. Recently, it was reported that the out-of-pocket costs for general practice consultations have risen to $60 for some practices, and the cost to fill a prescription has also risen quite significantly, at the same time, as we've seen increases in things like energy bills and mortgage payments, and everybody knows that when you go to the supermarket the bill at the checkout is significantly higher than it was.

Action to ensure continued access to critical health care must include a plan to relieve these significant cost pressures of living, which are only continuing to rise as we stand here today. This is why the coalition has been so concerned by recent notification of the government's decision that has resulted in a life-changing medicine, FiAsp, which is currently on the pharmaceutical benefits list—this particular drug is an insulin product. It's a new and innovative product that was listed in 2019, I believe. Over 15,000 Australians who have access to this particular product rely on it to manage their diabetes and their symptoms and alleviate the conditions and consequences of this.

The former coalition government listed this particular product on the PBS in 2019. That ensured affordable access to this fast-acting insulin for diabetic patients. But now it appears as if access to this particular product will no longer be available in Australia. That means those 15,000 plus people who have been relying on this innovative product will no longer be able to get access to these scripts. This puts extraordinary cost-of-living pressure on them because, if they are no longer able to meet those requirements or get access to it, the cost options of other products are significantly higher.

It's not only important that we look at ways in which the government can continue to supply critical medicines for Australians that rely on them. They must also make sure that those medicines are affordable and Australians can continue to have access to them, because the reliance on those medicines in this healthcare system is so important. As the previous coalition government, we were really pleased to have listed over 2,900 new or amended medicines on the PBS during the time that we were in government. This came on top of a 2012 admission by the previous Labor government that they'd had to stop listing medicines because they couldn't afford to list them. I hope the decision in relation to FiAsp is not one that will signal the return to new medicines not being listed and existing medicines coming off the PBS because they can't continue to afford to list them.

I absolutely want to reiterate that the coalition supports the necessary intention of this bill, and that is to strengthen the safe use of therapeutic goods and to support continued access to critical medicines. We do have concerns with some elements involved with this legislation, and we are particularly concerned by the way schedule 10 of this bill removes the natural justice hearing rule regarding publication of certain products, product information by the Therapeutic Goods Administration.

Product sponsors currently have access to natural justice prior to the proposed publication of information by the TGA, providing them with an important opportunity to respond to potentially damaging allegations made by the TGA in relation to their products. By removing this provision, it would deprive product sponsors of access to that natural justice before the product information is published, which could have potentially serious implications for these providers. It is also absolutely an underlying principle of this nation that natural justice is something that should be afforded to everybody. For this bill to seek to deny that natural justice to an organisation without the appropriate recourse that should rightly be afforded to them is a significant oversight. Obviously, we are particularly concerned about that, and we are hopeful that the government intend to rectify that.

So, by removing this provision we deprive the product sponsors of access to natural justice. And so while we support the need for the TGA to be able to urgently publish information relating to critical safety issues that significantly affect public health, this bill, in its current form, also allows the TGA to publish efficacy and quality related information where there is no corresponding urgency.

For these reasons we are keen for the government to amend this particular bill and to make changes to schedule 10 to only relate to the release of information on issues that relate to safety. On behalf of the coalition, I am more than happy to say that we will be happy to support this bill, although obviously we're very keen to make sure that the amendment to schedule 10 is moved.

Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

STEELE-JOHN () (): The Greens are broadly supportive of this bill; however, I flag here that we will be moving a number of amendments as circulated to the Senate.

The Greens particularly welcome that the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 has come from recommendations as a result of many people across the country sharing their really horrific experiences with the Senate community affairs inquiry into transvaginal mesh implants and related matters. Before I get to the end of my allocated time tonight and get cut off, I want to acknowledge the energy that it takes to share your lived experience with a Senate committee. And I want to thank the committee—including the then chair, former Greens Senator Rachel Siewert—for their work in developing the recommendations that have led us to this point.

The impact of transvaginal mesh for women was devastating—absolutely devastating. As quoted in the inquiry's final report:

[W]e believe this is a catastrophic failure of the health system to protect women and ensure they have access to safe health care. We feel that women have been let down by their doctors, by the manufacturers of mesh and by the TGA as the regulator.

Those are the keywords I want to keep in people's minds—a 'catastrophic failure of the health system to protect women' and 'we feel that women have been let down by their doctors, by the manufacturers and by the TGA'.

Now, the decision that will come before this Senate tomorrow will be whether we answer those calls with action—actually implementing the recommendations of the inquiry. So many gave their time and energy to generate those recommendations for a full mandatory reporting framework, not the half-baked half measure the government is putting forward this evening in the form of its definition of what healthcare facilities should or should not have to report. Let me state this clearly: the report really did not mince its words. All medical practitioners, as defined in the act, 'should report'. They should report to keep people safe. The Greens will be putting forward an amendment tomorrow to give effect to that recommendation.

Debate adjourned.