Mike Freelander (Macarthur, Australian Labor Party) Share 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.

See this speech in context