Gordon Reid (Robertson, Australian Labor Party) Share 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.

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