Melissa McIntosh (Lindsay, Liberal Party, Shadow Assistant Minister for Mental Health and Suicide Prevention) Share this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022. I note the carriage of the legislation by the Assistant Minister for Health and Aged Care and the work in this space by the member for Macarthur. I also acknowledge my colleague the member for Monash for speaking as he did on this bill previously. I want to acknowledge that the coalition supports this bill. I think that the member for Macarthur was a little harsh on the former minister for health. He had a serious pandemic to deal with, at the time of the release of these reports, and he did an extraordinary job in steering our country through the worst of those times.

I have personal reasons for supporting the bill. My mother had a hernia operation using mesh and had a very difficult time afterwards. I can understand the struggles and difficulties that many people, particularly women across this country, face when something that is meant to cure your issues instead leads to a lot of pain with not much resolution. These people have had mesh implants for various reasons.

The bill amends the Therapeutic Goods Act 1989 to implement a number of measures that seek to ensure the continued access to critical prescription medicines and support the safe use of therapeutic goods by strengthening post-market monitoring and compliance. I will speak further on this later in my contribution. The bill also introduces a framework of requirements for the mandatory reporting of adverse event information by hospitals across Australia, and I think that is extremely important for patient safety. In particular, I think about how much this mechanism may assist further in the issues of mesh implants.

A 2017 Senate inquiry looked into mesh implants and medical devices, developed in the late 1990s, which later caused widespread complications for many women across the country. This investigation emphasised the need for improvements in safeguarding patient safety through post-market monitoring, to ensure early detection of adverse events related to medical devices. It is beneficial for patients and clinicians to ensure that such devices are safe and effective. If devices need to be changed to provide for this, then that is what must happen to ensure that healthcare consumers are treated correctly. We all hope that they are not receiving those implants in the first place.

The Senate Community Affairs References Committee report of March 2018, Number of women in Australia who have had transvaginal mesh implants and related matters, listed 13 recommendations. Recommendation 1 noted that adverse event reporting plays a vital role in post-market surveillance, and proposed a scheme of mandatory reporting by health practitioners. The July 2021 government response to the recommendations of the report saw the previous coalition government having completed each of the 13 recommendations, bar recommendation 11, being noted, and recommendation 1, being substantially completed. The bill will assist the latter measure to support improved monitoring of safety signals and facilitate earlier detection and timely action to prevent adverse events and patient harm. Further, the bill will introduce a new dedicated marketing approval pathway for export-only biologicals and will support activities to relieve medicine shortages budget enabling the secretary of the Department of Health and Aged Care to approve the importation and supply of overseas prescription medicines that are substitutes for medicines that were previously approved in Australia. Additionally, this bill will support the safe use of therapeutic goods by strengthening post-market monitoring and compliance activities by introducing a general power for the secretary to require a new person to provide information or documents that are relevant to contravention or possible contravention of the act or related regulations and it will also assist in showing a better compliance arrangement.

The bill seeks to amend the act to also reduce regulatory burden by providing for an extension of time to pay amounts under an infringement notice, and for meeting therapeutic goods advertising that is directed exclusively to certain health professionals. Additionally, the bill will provide safeguards for patient safety in therapeutic goods advertising by allowing the secretary to withdraw the approval of the use of a restrictive representation in an advertisement about the therapeutic goods if new information about the good's efficacy comes available. Finally, the bill makes a number of minor amendments, principally to improve the clarity and consistency of regulatory requirements.

Although this side of the chamber and the coalition support the necessary intention of this bill, which is aimed at strengthening the safe use of therapeutic goods, we have some concern pertaining to the removal of a merits review right mechanism for decisions made by the secretary to require the provision of information or documents. I know, as an opposition spokesperson across the health space, that I, Senator Ruston—as a lead—and the member for Braddon will keep a close eye on how this process rolls out, and we will hold the government to account if these new powers end up straying from the policy intent of this amendment in the bill.

In considering the serious concerns at the moment for the availability of certain prescription medications, the coalition also calls on the Albanese Labor government to take further and urgent action to ensure the availability of critical medicines for Australians who rely on them every single day. Recent reporting has shown that the out-of-pocket cost for a GP consultation has risen to $60 or more for some people, and the cost to fill a script is around $55. This is occurring at the same time that the cost of living is rising, in particular household energy bills. We know with the recent interest rate rises for mortgage repayments that Australians certainly are feeling the pressure of these cost-of-living rises. We never want to have someone having to make a decision about whether they purchase medicines or put food on the table. Along with ensuring continued access to critical medicines for all Australians, the government must take action to relieve the cost-of-living pressures for families who are struggling to afford the cost of consults and scripts so they can continue to have these medicines. Action to ensure continued access to critical health care must include a plan to relieve these significant cost-of-living pressures.

In conclusion, the coalition supports the bill as it will assist Australian patients and people who have gone through extraordinary pain, particularly through mesh implants, to ensure a more compliant-safe and accessible medicine market.

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