Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020

03 February 2021

 It is a great pleasure to follow the member for Higgins, although, like her government, she is perhaps a little loose with the truth regarding some aspects of this legislation. Whilst this legislation has been seen to be just routine and not of huge consequence, I believe that it is and that this government has once again been a little loose with the truth. I want to speak on the Therapeutic Goods Amendment (2020 Measures No. 2) Bill and on the amendments put forward by my colleague the member for Hindmarsh. Firstly, I would like to congratulate the member for Hindmarsh on his new appointment. I look forward to working closely with him over the coming months. It is great to have his very analytical and scientific approach to the Health portfolio.

I couldn't pass up the opportunity to speak on this legislation, because I do think it is very important in many respects. As a doctor, I believe in science. I wholeheartedly support the independent experts at the Therapeutic Goods Administration, which is a body that has a critical role in making evidence based decisions as well as keeping Australians safe when it comes to consuming pharmaceuticals, using devices, compliance and a whole number of therapeutic modalities. We are in the middle of a global pandemic, and the role of the TGA is of critical importance in our nation's ability to respond to this very challenging health crisis.

However, the greatest threat comes from the government benches, with some very unscientific, very polarising and very nasty information coming from some members opposite, whose names I won't mention. I would say that freedom of speech does not mean freedom of responsibility. I'd like those opposite to reflect on that. Disgracefully, members of the Liberal-National government continue to pedal misinformation and mistruths and to spread division and conspiracy theories without thinking about the consequences. I don't want to lay wanton blame where it is not due, because I do think much of our response to the pandemic has been good, but we need to face reality about some of the measures talked about in this bill. I know that many issues are being brought in under the cover of darkness, if you like. The issues regarding drug shortages, for example, have been many years in the making, and this government has failed to respond in any reasonable way to the supply chain difficulties, to the manufacturing difficulties and to the lack of local ability to respond when shortages occur.

The TGA is a very important organisation. It was formed in 1989. As I have mentioned, it regulates the quality, supply and advertising of a whole range of things, including medicines, pathology devices, medical devices, blood products, many other therapeutics and also some devices that enable therapeutic treatments. Anything that has a therapeutic effect or is used to administer a therapeutic effect must be approved by the TGA. For some years, the TGA has been led with great distinction by Professor John Skerritt, and it continues to do a wonderful job. On 25 January, the TGA provisionally approved the Pfizer-BioNTech COVID-19 vaccine, the first one approved in Australia, and I personally can't wait for the rollout of the vaccine. There's much we don't know about the future of COVID-19, but these new vaccines are very safe, and they will cover many of the mutations that are already appearing.

I cannot emphasise enough how important the TGA is in keeping Australians safe using their scientific ability to examine all the things that are used for medical treatments in Australia. I cannot emphasise enough their expertise, their approach to the science and their ability to make sure that vaccines, in particular, are very safe. Some of the information that's coming from the government benches is very, very bad in terms of public health and public confidence. I want to assure everyone that our TGA is the best medicine and device approval organisation in the world. Other countries envy it. We should be very glad that this is the organisation that is assessing and approving our new vaccines for COVID-19. It is keeping all Australians safe and is allowing us to access the novel treatments, the new treatments, that are now becoming available for a whole variety of diseases and illnesses, thanks to science, around the world. In particular, you may have read a recent Department of Health survey that demonstrated that, in the last 10 years, deaths from cancer have dropped pretty dramatically around Australia because of the new treatments that we have access to due to TGA assessment and approval.

This therapeutic goods amendment bill is described as non-controversial, but I do have significant concerns across a whole range of areas. This bill amends the Therapeutic Goods Act. Its main provisions are to facilitate the importation of COVID-19 vaccines to Australia. The member for Higgins and others have mentioned the difficulty with labelling, particularly labelling vials that have to be kept at minus 70 degrees Celsius. The bill also allows importation of the new vaccines, if they're approved to be used on Australians, without the TGA product number on them. As you can imagine, we need to be very nimble and very flexible in getting these safe vaccines into the country and distributed to all Australians. There are many vaccines in the development stage that will be becoming available. It's said now that the vaccines that we're getting will not be the best vaccines for COVID-19 in the future—and there are over 200 different vaccines still being examined and assessed around the world. This bill will allow us to get the vaccines to the Australian population as quickly and as nimbly as possible.

This new bill will also allow pharmacists to substitute medicines where certain shortages arise. It will allow the minister to declare a serious shortage of a particular medicine, and a substitute medicine can then be dispensed by pharmacists in circumstances in which substitution is permitted. As a prescribing doctor, I do have some concerns about this. I know that for many years the government has not adequately addressed shortages of medications around Australia. The member for Higgins mentioned EpiPens. At times there are still shortages of EpiPens. There are a number of reasons for this. There's only one manufacturer producing the autoinjector of adrenaline, which is the EpiPen. There's no alternative to the EpiPen listed for use on the PBS. I know that shortages can occur, and this is incredibly distressing for patients who have anaphylaxis. I myself have bee sting anaphylaxis. My granddaughter has nut anaphylaxis—true anaphylaxis, where she collapses and loses consciousness and her blood pressure drops if she has tree nuts and has no access to an adrenalin autoinjector. This is very troubling for parents. We know that these shortages have been present for years, and the government has failed to address this issue. We know there have been shortages for a number of different medications, including the antiepileptic Epilem, sodium valproate, which is the most common antiepileptic medication used in Australia.

A number of times, there have been shortages of appropriate strengths of Epilim. As you can imagine, for someone who has epilepsy, this can be very distressing. There've been shortages of common antibiotics. We, through CSL, used to manufacture most of our penicillin-derivative antibiotics, and others, in Australia. We no longer do that. The government has failed to address supply chains for the common antibiotics. There've been shortages of desmopressin—which is used for, amongst other things, a type of illness called diabetes insipidus and also for enuresis, or bedwetting—a number of times over the last three or four years. Again, this was not addressed, because of the supply-chain difficulties. We know that there've been shortages in a number of treatments for ADHD. It can be very distressing to families who have a child with ADHD if they can't get their medication. The government is, under cover of darkness, if you like—the pandemic—introducing this legislation and pretending the supply-chain difficulties are due to the pandemic. They are not. They are due to the fact that this government has failed to address pharmaceutical supply-chain difficulties for a number of years.

This legislation will also facilitate the development of a device identification database. Labor has been calling for this for years and years and years. This means that people who have implantable devices—for example, those used in orthopaedic surgery, for hip replacements and knee replacements et cetera—can be identified and they can be recalled if required. You may remember there was a problem with some hip-joint replacements some years ago. The metal was leaching from these devices, causing a number of medical problems. It was very difficult to follow up these patients and recall them, as they couldn't be adequately identified because of the lack of a national database. Labor called for the introduction of a database some years ago. The government has been so slow to respond to this. It's been years since this has been called for. It's only now coming into effect. It also means that patients who have things like pacemakers, some cardiac valves or a number of different implantable devices for neurological surgery can be easily tracked and easily followed.We've been calling for this for years. It's so late in the day that the government is introducing this, but at least it's happening at last.

I have a number of concerns about the database. The government are very prone—and the future in health is in the data—to selling off our health data to private organisations. I would mention that, when I came into parliament in 2016, the government very surreptitiously sold off, without any appropriate public discussion, our breast cancer registry to Telstra Health, putting that data all in the hands of a private organisation. We have a Medicare platform that could be easily used to access and collect this data. The government sold off that very important health information, that health data, to a private company and is doing it even as we speak. Can you believe this—they announced on the evening of Christmas Eve that Accenture, a huge data company, was the data partner for the COVID-19 vaccine rollout. There's only one reason why you would introduce that announcement on Christmas Eve: you want to keep it secret, because you're again selling off our health data to a private organisation. Under cover of darkness, that's what the government are doing. Will they be doing that with our device register? They won't tell us, but I think they will. That's what they'll want to do—sell it off to private enterprise, removing it from public access and removing it from our research organisations et cetera, probably unless they pay a fee. So that's one aspect of this legislation that I think is a major concern.

Even though we agree with the spirit of this legislation, I have major concerns about some aspects of it. There are no details about how pharmacists are going to be able to change medications, and unless this government does something about the supply chains there will be shortages in the future; that's for sure. Yes, we agree with this legislation and the amendment moved by the member for Hindmarsh, but I do have major concerns about this government's response to health care in general and about its ability to maintain good health care for all Australians.