Mike Freelander (Macarthur, Australian Labor Party) Share this | Link to this | Hansard source

I rise today to speak on the Therapeutic Goods Amendment (2022 Measures No. 1) Bill, I thank the minister for introducing this bill, which involves a very important piece of legislation. It carries on the Albanese Labor government's attempts to modernise our health system and our health regulatory environment.

We've had 10 years of stagnation. Of course, the previous government was a very tired old government. I feel a bit sorry for the previous health minister. He failed to respond, in many ways, to the challenges of our health system, as did his predecessors in the Liberal-National government. I am a member of the Standing Committee on Health, Aged Care and Sport, which held an inquiry into how we approve new drugs and devices for use by the Australian population. The previous health minister didn't even give us the courtesy of a response to that report, The new frontier, as indeed he didn't even give us the courtesy of a response to our previous report, which was on juvenile arthritis.

This bill is a continuation of the Albanese government's plans to modernise and bring up to date our health system and our health regulatory system. When I saw this legislation was listed for debate, I simply couldn't pass up the opportunity to speak on it. As a paediatrician, I believe in the science and the expertise behind our health system, and I wholeheartedly support the independent experts at the Therapeutic Goods Administration, the TGA. This is a body that has a critical role in making evidence based decisions about the medications we use in Australia and about the devices we use in medicine—for example, things like joint replacements, cardiac catheters, pacemakers and a whole range of different devices that are used in health care in Australia. The TGA has a critical role in keeping Australians safe when it comes to consuming pharmaceuticals and using devices in health care. It takes on evidence from industry and from professionals.

I've no hesitation in standing here today to support this bill. Under the amendments to the TGA Act via the therapeutic goods amendment bill, issues with devices and some pharmaceuticals that we use in health care are identified to enable complications and problems that may occur in their use to be notified in a systematic way, and to enable the TGA to recommend the withdrawal of approval or special restrictions on use of certain devices. It improves the mandatory reporting of adverse events by expanding the categories of people who can report adverse events, and it assists in addressing some of the other issues that can be involved in using medications and devices in Australia. We have at the moment, particularly following the pandemic, supply chain issues, and it may well be that there are shortages of certain medications and certain medical treatments—even different tests that are used in biochemistry, haematology et cetera. This will enable alternatives to be used and accessed very quickly. So it's very important in ongoing monitoring of health care.

In Australia, we now use very complex methods of treatment for a whole range of conditions, including cancer, cardiac disease and some autoimmune diseases, such as SLE or lupus. Some immune disorders are treated using biological medications that are genetically targeted, and this legislation will help monitor their use for some often very rare disorders and enable complications to be reported very quickly. It will do the same for the newer medical devices that are now used in, for example, minimally invasive cardiac surgery to do things like replacing heart valves and repairing congenital heart defects, holes in the heart and other conditions. It will enable very quick reporting of complications to the TGA and notification of those complications to physicians and also to the general public.

Currently, the sponsors of medical devices and device manufacturers are required to report adverse events relating to medical devices to the TGA as part of an incident reporting and investigation scheme. This tightens up the regulations and allows more people to be able to report those complications. I know from my experience working in the public hospital system that previously the reporting of these adverse events was often delayed because of, perhaps, investigations by the local hospital or the lack of one person designated to report adverse events or the lack of a systemic collection of data. This legislation will enable that data collection to be improved. It is, I might say, a really long-overdue improvement in those reporting conditions and in the ability to report to a central body, the TGA. We've seen many, many problems in the past because there has been either no reporting of adverse events or a delay in reporting adverse events in a systematic and systemic way. So this is really long-overdue legislation.

It attempts to reduce the regulatory burden for people who manufacture in Australia, particularly things like biological medications and devices. It makes it easier by having a streamlined marketing approval pathway for treatments, particularly biologicals that are used for export, and it supports innovation and investment in biologicals and also manufacturing in Australia.

There have, of course, been several devices that in latter years have been found to cause severe complications and adverse events in many, many patients. This includes a particular hip replacement, which was a metal-on-metal hip replacement for the ball-and-socket joint at the top of the femur. There were adverse events but, because of delays in reporting, it was not realised that there were such large numbers involved until, unfortunately, it eventually came to legal action. That's when it became apparent that there were actually large numbers of the complications involved. Many of those complications had not been reported to the central body, the TGA. So this is an attempt to avoid problems like this. Also, people may remember the surgical mesh that was used as part of many operations to improve continence in people who had what's called uterine prolapse. The vaginal mesh was used for this surgery as well as other types of gynaecological surgery to try and prevent prolapse of the uterus, but it caused severe surgical complications in a number of women and, unfortunately, again, did not come to general notice until legal action was proposed. This is a failure of regulation in the health system which this legislation will attempt to address.

If we can work together with industry to mitigate the risk of these occurrences, it will guarantee that people receive treatment which is of the best quality, and people who are administering these treatments can feel confident once the device is approved by the TGA that ongoing monitoring of side effects and complications will occur in a timely manner, which will help improve our health system overall. It will also improve our public and private hospital systems, and it will make patients more confident in the treatment they are receiving to know that any complications will be reported in a timely and appropriate manner.

During a recent visit to PNG as part of a parliamentary group looking at healthcare in that country, it was easy for me to see there how unregulated health systems for things like medications and devices can lead to major problems. We are lucky in Australia to have a system like the TGA, but this is, again, an improvement on that system.

In my electorate of Macarthur, I've also heard countless stories from constituents who've expressed their concerns about being able to access critical medications which they require urgently. Recently I was contacted by a patient of mine who has a rare neurological condition called myasthenia gravis and was very concerned about the lack of availability of a particular medication that is used and can be life-saving for people with myasthenia gravis. With the help of the minister's office, I was able to finally work out what alternatives were available. This legislation will help make it much, much easier for physicians and the general public to access that information and for the alternative medications to be made available to patients. It is very important, particularly for people who are facing shortages of either devices or treatments, that they can use an alternative for their current therapy when supply-chain difficulties mean the primary medication or treatment that they're on becomes unavailable.

Another patient contacted me about the lack of availability of a certain flanged enteral feeding tube, which is a tube that goes from the abdomen into the stomach, to provide food for their child. Unfortunately, because of supply-chain difficulties, they'd run out, and it took us a long time to find out what alternatives were available. This legislation will help in that kind of situation.

A pivotal aspect of this bill is to provide an expansion of the secretary's information-gathering powers to guarantee efficient and timely responses if there are side effects or complications. The expansion of this power of gathering data is very, very important and is very relevant. For issues where there may be concerns expressed in one place, the information gathering can now look Australia-wide. It makes third parties who want to notify the TGA of complications more confident that their information will be taken on board and used seriously. This bill will also remove merits review rights for decisions by the secretary to require the provision of information or documents, to prevent those pathways being used to delay provision of information about complications. That is also very important.

I should also mention in finishing that I have the utmost confidence in the TGA, having worked closely, in my role in the chair of the Standing Committee on Health, Aged Care and Sport, with them and with the professionals involved. I was very saddened to hear of the proposed retirement of Professor John Skerritt, the head of the TGA, to take place in April this year. He is one of the very best public servants I have ever met. Australia should be incredibly grateful for the systems that he has introduced over the 11 years he's been in charge and for the way he has helped modernise the TGA to deal with the expanding range of new treatments, medications and devices that are becoming available in the 21st century. This is expanding in an exponential way, and we have done very well, particularly during the pandemic, because of the work of Professor John Skerritt. I am very grateful for his service to this country. He is a great Australian, and I will certainly miss him.

I commend this bill to the House. It's another way that the Albanese Labor government—in particular, the Minister for Health and Aged Care—is helping to modernise our health system.

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

Gordon Reid (Robertson, Australian Labor Party) Share this | Link to this | Hansard source

First of all, I want to thank members who have spoken on this piece of legislation today and commend the work of the assistant minister and minister on the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022. This bill, this legislation, is going to amend the Therapeutic Goods Act 1989 in a number of key areas that I believe to be quite important. The purpose of these amendments are to principally to improve the post-market monitoring of adverse events related to medical devices. This is a key aspect of this legislation that I am going to touch on quite significantly here today. It will: reduce the regulatory burden for sponsors of export-only biologicals—biologicals, as we know, are an extremely important form of medication in treating, in particular, immune and autoimmune diseases; strengthen compliance and enforcement activities; update the regulation of advertising on therapeutic goods; and, finally, strengthen options for dealing with medication shortages, which is an issue, not only in my home electorate but right across the country. All of these key changes are vital in supporting improvements to the safety of the patient, reduce ongoing regulatory burdens, support timely access to therapeutic goods, and enhance compliance and enforcement activities.

Let's get down to the nitty-gritty of what we're here to do today—talk about this bill. As a parliamentarian and as a doctor who continues to practise in the emergency department, I am all about what the specifics of this legislation are trying to achieve, especially when patient safety has the chance to be improved. As a practising clinician in our emergency departments in our hospitals, I know that patient safety is paramount, so any opportunity to analyse and improve on this area is absolutely welcome.

This bill will introduce requirements for mandatory reporting by hospitals of adverse events involving medical devices and for improving the monitoring of the safe use of medical devices in Australia. This focus on adverse event monitoring is absolutely crucial, absolutely vital. Adverse event monitoring is not only essential for patient safety but it's really important for strengthening that therapeutic alliance between clinician and patient, and also between government, the health bureaucracy and the patient as well. These changes will likely help mitigate device related risks and allow for safety and ongoing use, because, at the end of the day, what we're trying to achieve through this legislation and many others is preventing serious injury. We're trying to prevent serious harm or deterioration of the patient in our health service, including death. An important focus of adverse event monitoring is information and data collection, as this will allow for and help ensure that clinicians and relevant staff have access to the most up-to-date and clinically relevant information when assessing, diagnosing and, more importantly, treating patients in our health service, whether that be in our emergency departments or in our intensive care units, on the ward or in the community.

To move further, this bill also looks to introduce a streamlined marketing approval pathway for biologicals that are for export only, to support innovation investment in biologicals in Australia and to reduce the regulatory burden for such products. As we know—for the benefit of the chamber and those listening on at home—biologics are a substance produced by a living organism that is generally used in the prevention or treatment of disease, especially in malignancy and also in immune-mediated diseases. Some of those that come to mind are rheumatoid arthritis, which I've personally seen quite severely debilitate patients. Patients have quite a severe physical deficit from that disease. It also causes quite systemic problems with the patient such as Crohn's disease, a form of inflammatory bowel disease which can lead to an ulceration and a degrading of the bowel, with multiple surgeries required. I can't understate the importance of biologics in the therapeutic setting and in the clinical setting.

It's also going to remove the merits review rights for decisions by the secretary to require the provision of information or documents to prevent merits review pathways from being used to delay the provision of information or documents and compromise efforts to assess the safety of therapeutic goods and possible contraventions of the act. Again, to focus on ultimately patient information-gathering power for the safety, it will introduce a general information-gathering power for the secretary to require the provision of informational documents relevant to a contravention or possible contravention of the act from any person, including third parties, to support monitoring and compliance activities and product safety.

Moreover, it also allows seized goods to be retained for the 120-day period instead of the current 90-day time frame. This is going to allow sufficient time for seized goods to be assessed by the TGA and, potentially, form evidence supporting enforcement action.

Furthermore, the bill will reduce the regulatory burden for therapeutic goods' advertisers by providing that the enforcement provisions relating to advertising do not apply to advertisements directed exclusively to people purchasing therapeutic goods on behalf of governments or registered charities, or to purchasing officers or practice managers in a healthcare practice within that setting. To continue along the same vein, with advertising, the bill contains measures to allow the secretary of the Department of Health and Aged Care to withdraw approval of a restricted representation in therapeutic goods advertising if new information about the efficacy of those goods or that drug becomes available, to reflect that it may no longer be appropriate for the restricted representation to be used in such advertising.

I should also just mention that this bill will also contain measures to clarify that the natural justice hearing rule is not required to be observed in relation to the release of the therapeutic goods information, to ensure that critical information about the safety of goods is able to be released without any delay or obstruction. Also of note is that it will seek to clarify that sponsors of reportable medicines—principally, prescription medications—that are in short supply must provide updated information about the shortage and its resolution to the secretary.

I'll just go over the key elements of this bill once again, and I'm going to go through them again because they are vital to what we're talking about today. One element is to improve the post-market monitoring of adverse events relating to medical devices. I've gone through why it's so important to collect that data and information on adverse events. Not only does that therapeutic alliance strengthen patient safety, but it also provides clinicians—whether they be in the emergency department, on the ward or in a clinical setting within a hospital—with the most up-to-date information regarding those medical devices.

There's also reducing the regulatory burden for sponsors of export-only biologicals. We've gone through why biologicals are such an important pharmaceutical medication in our health service. Examples are of patients suffering from diseases like rheumatoid arthritis and those seronegative spondyloarthropathies, and also from diseases like Crohn's that significantly affect the bowel and can lead to long-term morbidity and, ultimately, mortality in some patients. That's where biologicals really come in handy and provide a good therapeutic benefit.

It'll also strengthen compliance and enforcement activities, which we've gone through, and update the regulation of advertising of therapeutic goods. It will also strengthen options for dealing with medication shortages, which is absolutely vital in our health system. It's a problem, not just in my electorate but right across the country. The assistant minister, who is here today, and the Minister for Health and many in our caucus recognise that that is an issue, and that's what this bill goes to. This is one of the ways that the Albanese government is making sure that medications are more accessible to the general public—in particular, in that clinical environment.

I make reference to the recent legislative changes that we made, with regard to PBS prescription medications—lowering the price from $42.50 down to $30 per script, which is quite a significant saving and not just a cost-of-living measure, might I add. Just to comment on what the member was previously discussing: it's not just a cost-of-living measure that we're providing the community; it's also a life-saving measure, as people won't have to ration their medications by taking them every second, third or fourth day.

Take a disease like atrial fibrillation, where the heart doesn't beat correctly and a clot forms and that clot then shoots up to the brain. We treat that with an anticoagulant. I think of an example like Eliquis, or apixaban, that thins the blood. That's critical in preventing stroke from that heart condition. That's one of the drugs that will be impacted by our changes to the Pharmaceutical Benefits Scheme.

There are also changes to asthma medications, which are vital. We want to make sure that we're preventing exacerbation or worsening of asthma. That's preventing ED admissions; that's preventing admissions to the intensive care unit of people requiring significant respiratory support.

Finally, as to some of the diabetic medications, we're also making sure patients can access them faster. When we look at a patient with type 2 diabetes, if that patient is not taking that medication regularly and they have sustained, unregulated high glucose levels or high blood sugar levels, then we see those micro- and macro-vascular complications of diabetes. What I mean by that is the retina being damaged and causing blindness. I mean that the kidneys become degraded. The functional unit of the kidney becomes degraded so much that patients are going to require dialysis long term, whether that's peritoneal, through the tummy, or haemodialysis, through the arm and through the veins in order to clean the blood—do the job that the kidneys would normally do. I think of nerve damage in the extremities, in the arms and the legs, and also damage to the blood vessels in those extremities. And what does that do? It means that, if someone were to suffer a burn or an abrasion on the foot, and they don't realise and they haven't felt it and it doesn't heal, that can become an infected wound that will ultimately go to gangrene and then probably require amputation of the limb. So access to medications is vital. They're a vital part of the therapeutic and clinical context.

In this bill, the Pharmaceutical Benefits Scheme changes are part of the Albanese Labor government's commitment to not only strengthen Medicare but strengthen patient safety, strengthen the therapeutic alliance, and make sure that government and health bureaucracy have options to make the changes that we need to undertake to benefit the patient, because they need to be at the centre of this. The patient needs to be at the centre of everything that we do in this place, in the House of Representatives and in the Senate. They need to be at the centre.

In closing, I'll say that all the changes in this bill are vital in supporting improvements to the safety of the patient; reduce ongoing regulatory burdens; support timely access to therapeutic goods; and enhance compliance and enforcement activities. It's good for patient safety, and it's good for the therapeutic alliance.

Ged Kearney (Cooper, Australian Labor Party, Assistant Minister for Health and Aged Care) Share this | Link to this | Hansard source

I thank the member for Robertson and the member for Macarthur for their contributions to this debate. It's really wonderful to have such knowledgeable, hands-on doctors in this government who understand—along with you, Madam Deputy Speaker Ananda-Rajah—the arguments as to why this bill is very important. There were real, firsthand examples of how it's going to make a difference to people's lives. Of course, I'd like to acknowledge the member for Lindsay as well, who is clearly across the subject and also knew just how this measure is going to improve health care in Australia for Australians. I'd also like to acknowledge the member for Monash, who, when I introduced this bill, made a very passionate plea for its support with respect to members of his constituents who had been impacted by the vaginal mesh disaster. So thank you to all of those members for their support.

The Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 amends the Therapeutic Goods Act 1989 to implement a number of measures which support the delivery of the highest quality health care for the Australian public by ensuring continued access to critical prescription medicines and supporting the safe use of therapeutic goods by strengthening therapeutic goods post-market monitoring and compliance. In particular, the bill supports the implementation of a scheme for the mandatory reporting by hospitals of adverse events associated with medical devices. This measure would support the improved monitoring of safety concerns associated with medical devices through access to information held by hospitals that identifies serious adverse events, and earlier detection of safety signals that may raise concerns about particular devices.

The bill encourages innovation and investment in biologicals in Australia by introducing a new, dedicated pathway for marketing approvals of biologicals that are for export only. The bill addresses and alleviates the effects of medicine shortages by amending the act to allow the Secretary of the Department of Health and Aged Care to approve the importation or supply of an unapproved medicine that could act as a substitute for medicine that was previously approved in Australia. This measure is designed to ensure the continued supply of critical prescription medicines in Australia.

The bill supports the safe use of therapeutic goods by strengthening monitoring and compliance activities through a number of measures, including stronger information-gathering powers, extending the time frame for retaining seized goods and allowing the due date for an infringement notice to be extended once the due date has passed. The bill expands the persons to whom therapeutic goods advertising may be directed to include certain health professionals, persons purchasing therapeutic goods on behalf of registered charities or governments, and purchasing officers or practice managers of a healthcare practice. The bill also provides a mechanism for the approval of a restricted representation to be withdrawn where additional information about the efficacy of therapeutic goods becomes available, ensuring that advertising only contains correct and accurate information and reducing the risk of unsafe use by consumers. I thank everyone for their contributions to the debate on this bill.

Question agreed to.

Bill read a second time.

Message from the Governor-General recommending appropriation announced.

Ordered that this bill be reported to the House without amendment.