Jordon Steele-John (WA, Australian Greens) Share this | Link to this | Hansard source

In continuing my remarks, I acknowledge the origin of this bill, that being the Senate Community Affairs References Committee's inquiry into the impact of transvaginal mesh on women in Australia. I offer once again my heartfelt acknowledgement and commitment to the community that gave evidence before that inquiry. It takes an incredible amount of strength and emotional energy to come before a Senate committee and share your experiences of such horrific medical harm from these devices. Yet people did that, families did that, mothers did that in the hope that it would result in legislative change that would ensure that no such travesty was ever again inflicted upon members of the Australian community, that nobody ever again went in for a medical device to deal with something as simple as incontinence and came out with something inside them that caused them a lifetime of pain. I want to thank all those who gave evidence to that inquiry and commit myself and the Greens movement to working with you until every single one of those recommendations is fully implemented.

In contributing to this legislation, I also want to foreshadow that there will be a couple of other second reading amendments that we will be moving. One will be moved by my colleague and dear friend Janet Rice, and that amendment will be in relation to blood donation. This motion will be moved by Janet on behalf of the Australian Greens as a second reading amendment to this TGA legislation. If it's successful, our amendment will see the TGA bring equality to blood donation laws. It will remove barriers to gay and bisexual men, transwomen and some non-binary people who have sex with men from donating blood. Specifically, the Greens are calling on the TGA to replace the current approach of population-based risk assessment and the three-month deferral period with an approach that is based on an individualised risk assessment. This is not a radical idea. This is something that has been done in the UK, and the evidence fully supports it.

This amendment is in solidarity with the Let Us Give campaign. It responds to the need for more plasma and more whole-of-blood across the entire country. I want to acknowledge, and I want to thank, the campaigners who are part of that campaign who are doing incredible work in this space to make sure that we get rid of the discriminatory practices that currently exist in this space and replace them with an individualised system based on equality.

We must stop discriminating against those who give blood. We must look at the evidence and go with the science. The reality is that there is no increased risk to allowing this group to donate blood following an individual risk assessment. It is time to ensure that all Australians are able to donate equally. It is also time to recognise the decades we have taken to make this change. The barriers, ultimately, weren't the science. The science was the excuse for the discrimination. This is something the community has always known. They've always known the reality of this. But we come to this space in 2023 with a government still dragging its heel, and that is proof positive that this is the case. We've got to end that discrimination and allow people to donate equally.

The second amendment, which will be moved by myself on behalf of the Australian Greens, relates to medicinal cannabis. We will be seeking to move the second reading amendment in recognition that, while medicinal cannabis is legal in this country, too many people cannot afford to access it. Particularly, this amendment relates to the TGA's role in ensuring that patients who require medicinal cannabis for therapeutic use are able to access it.

This amendment asks the Senate to recognise the findings of the Community Affairs Committee inquiry into the barriers to patient access for medicinal cannabis in Australia. This report was released in 2020, with many recommendations yet to be implemented. I'll quote directly from the report from former Greens leader Senator Richard Di Natale, who worked on the inquiry:

During that inquiry the parliament heard from patients across the country who are unable to access the medicinal cannabis treatments they need due to regulatory barriers and enormous cost. Cost is a hugely prohibitive factor for patients needing access to medicinal cannabis; they just can't afford it. Although the government has said, 'Look, we accept that it has therapeutic benefits and we will allow it to be placed on the register,' the cost is still so high that the people who need it just can't get it. It is completely unacceptable that people can be out of pocket thousands of dollars when trying to access legal medicinal cannabis products through a regulated system when the black market is far cheaper.

Three years on from this report, nothing has changed. People still cannot access medicinal cannabis and they are still unfairly punished when they try to do so.

We have the experts, the majority of the public and the clear findings of the Senate committee itself saying, 'We need to take action.' The system at the moment is broken, and it is the patients who are paying the price. This is what this amendment seeks to address. The Greens encourage the Senate to work in line with the community need, the clear evidence provided to this place, and to support this amendment. In relation to the medicinal cannabis amendment, I move:

At the end of the motion, add ", but the Senate:

(a) notes that:

(i) in 2020 the Community Affairs References Committee, as part of its inquiry into current barriers to patient access to medicinal cannabis in Australia, examined the difficulties for patients in accessing medicinal cannabis through current pathways and regulatory schemes, as well as the substantial barrier of cost to patients; and

(ii) the committee made various recommendations to the Government aimed at improving access to medicinal cannabis, but not all of these recommendations have been accepted or implemented; and

(b) calls on the Government to:

(i) ensure that affordable medicinal cannabis products are available to all patients who require them for therapeutic use; and

(ii) consider and implement the outstanding recommendations from the Community Affairs References Committee inquiry".

Janet Rice (Victoria, Australian Greens) Share this | Link to this | Hansard source

It's terrific to be able to speak to this bill today. I want to start by saying that I support the comments made by my colleague and dear friend Senator Jordon Steele-John in relation to the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 overall. I thank him for his important advocacy in the health portfolio and the work that has been done on the issues in this bill.

I want to particularly speak to the issue raised in my second reading amendment, an issue I have worked on in this place for a long time. This is about the restrictions on gay and bisexual men, trans women and some non-binary people who have sex with men being able to give blood.

My amendment says the Senate calls on the government and the Therapeutic Goods Administration to urgently remove barriers to gay and bisexual men, trans women and some non-binary people who have sex with men from giving blood, including by replacing the current approach of a population based risk assessment and a three-month deferral period with an approach based on individual risk assessment.

This is an issue that I have been advocating for many years. I have raised this issue repeatedly in Senate estimates and I have had discussions about it with the Department of Health, the Therapeutic Goods Administration and Lifeblood. It's an issue that doesn't seem to have made any progress in the time that I've been advocating on it as a senator. It seems that there's this merry-go-round. The health department is saying it's the responsibility of the TGA, the TGA is saying it's the responsibility of Lifeblood and Lifeblood is saying it's the responsibility of the TGA. When I asked questions at last estimates, there was another agency, blood—I can't even remember its name, 'Blood Donations Australia' or something. The TGA said, 'I think you need to talk to them about this.' We need to stop this merry-go-round because what's going on is discrimination against men who have sex with men.

It's an issue the LGBTIQA+ advocacy community have been concerned about for a very long time. It's an issue that's been addressed in other jurisdictions that have shifted from having that population based risk approach to an individual risk assessment. For the life of me, I do not know why it has taken so long for Australia to also be making this change. Other than that, you have to cynically and sadly feel that there is just an ongoing level of discrimination against same-sex attracted people that exists in some of the bureaucracy here within the Australian government. I'm no longer the Greens spokesperson for LGBTIQA+ advocacy. My colleague Mr Stephen Bates, in the other place, is continuing that excellent work but I'm very pleased to be here in the Senate raising this issue.

I want to let you know of some of the campaigning that's been going on in the community on this issue. Just.Equal have coordinated a campaign from doctors, nurses and other medical professionals, calling for an approach that isn't discriminatory. As an open letter by medical professionals says:

We are Australian health professionals who want the blood supply to be safe, more abundant and less discriminatory.

We support a policy that screens potential blood donors for their individual risk, not the gender of their sexual partner.

We believe the current ban on blood donation by sexually-active gay and bisexual men, and transgender people, reduces the amount of blood available without making the blood supply safer.

A better policy would be to focus on activity that actually creates risk and to screen potential donors for that risk, regardless of sexuality or gender identity.

I could not agree more. This is the approach that we really need to see being taken, and that change must happen urgently.

Since we foreshadowed this second reading amendment, we have had some feedback from the health department and some fairly good news. We are now being told that Lifeblood has announced that they will undertake research to decide whether to replace the current population based risk model with an individual risk assessment approach for blood donation and that the TGA is working closely with Lifeblood to facilitate this research and review over the coming months, subject to review by independent advisory committees.

Just from putting this second reading amendment on the notice paper, it seems that we are finally seeing some action. I urge that that research happens very urgently, that we draw upon the extensive research of other jurisdictions around the world and that we stop the discriminatory processes that are currently being undertaken.

We have come a long way with ending discrimination against LGBTQIA+ people. The wonderful experience of Sydney WorldPride and Mardi Gras, which I attended the weekend before last, was an extraordinary celebration of the contribution that lesbian, gay, bisexual, transgender, gender diverse, intersex and asexual people make to our community. We really need to continue taking every action we can to reduce discrimination against LGBTQIA+ people and to change how we screen blood. Going to an individual risk assessment approach is one very tangible, very important measure that we in this parliament can take to achieve equality for LGBTQIA+ people.

Pauline Hanson (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

I rise to speak on the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022. One Nation will not support this legislation. This bill is so flawed. It needs to be reviewed by a committee, but Labor, of course, is following its new procedure and ramming through legislation without giving this Senate the opportunity to review and improve it. Mark Butler should hang his head in shame.

The most concerning provisions in this legislation are a direct attack on a foundational principle of Australian law and a fundamental human right: the presumption of innocence. It's sad to have to say this, but this government needs to be reminded that in Australia it's up to the prosecution to prove guilt, not the defence to prove innocence. I also remind this government that it is simply not allowed to interfere with this human right in any way, most definitely not for the sake of Public Service bureaucrats.

I have to remind this government of this because it's not only this bill which threatens this principle but others on the Notice Paper for this week as well. Labor does not have a mandate to interfere with human rights. It does not have the permission of the Australian people. The committee report on the TGA bill makes it quite clear that the proposed section 45AC, creating an offence for failing to produce information and documents for the secretary, also creates new, strict liability offences that can attract a penalty of up to $27,000. Subsection 45AC(3) provides for a reasonable excuse, but places a burden on the defendant to prove they are innocent. This is, effectively, a presumption that the defendant is guilty of the offence.

Labor has no excuse for this. As a government elected by the people of Australia, one of the most important duties is to protect their rights, not attack them. However, the bill goes further. Proposed new subsection 61(13) explicitly states that the secretary does not need to observe procedural fairness or the natural justice hearing rule with regard to releasing information collected under the act. That's right: Labor doesn't support procedural fairness. Perhaps an even more concerning part of this bill relates to the importation of medicines. The proposed subsection 19A(2B) gives the secretary the power to grant approval to importation or supply of therapeutic goods, including mRNA vaccines, but it does not specify safety testing of these goods and doesn't provide for a sunset clause on the approval. I note there are a range of other conditions for approval, including the catch-all in the interest of public health.

As we saw to our horror during the COVID-19 pandemic, many fundamental human rights in Australia came under direct attack in the so-called interest of public health: freedom to travel, freedom of assembly, freedom of association, freedom to choose and even freedom of speech. It wasn't just Labor governments doing this; coalition governments were equally guilty of trampling all over our rights. They were in it together. Some of us might be forgiven for thinking that, with the pandemic effectively over, that might be the end of the violation of our rights in the name of public health. However, it might have only been the beginning.

In May this year a meeting of the World Health Assembly will consider proposals for a World Health Organization pandemic treaty and changing the international health regulations. These proposals threaten not only our human rights but the sovereignty of Australia. They threaten to transform the hopelessly corrupt World Health Organization from an advisory body to a governing body able to make legally binding proclamations on the world's nations. They threaten to remove the requirement that these corrupt international bodies have respect for the dignity, human rights and fundamental freedom of persons. They threaten to give the WHO control over national means of production, enabling it to force countries to manufacture medicines or vaccines. They threaten to give the WHO the power to force medical examinations and treatments on individuals and force people to carry certifications about tests and vaccinations. They threaten to give the WHO the power to disclose personal health information and to censor whatever it considers to be misinformation.

What's the bet that this Labor government will roll over and just allow this all to happen? No bet here; of course they will. They don't believe the rights of the individual take precedence over the interests of the state, but let me tell you: nothing is more dangerous to a free society. This government and every government which comes after should be required to take an oath that they will not subordinate the rights of human beings to the interests of the state, let alone unelected international bodies wanting a one-world communist government.

Ralph Babet (Victoria, United Australia Party) Share this | Link to this | Hansard source

Obviously I rise here today to speak in regard to the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022. I support various aspects of this bill, including the introduction of a mandatory medical device adverse event reporting scheme for hospitals and other healthcare facilities. I acknowledge that the TGA has an important role to play in managing medicine shortages. They have an important responsibility to find suitable substitutes to ensure that Australians have access in a timely manner to the medications that we all require. The bill in part seeks to address critical shortages on life-saving medications—for example, I know that warfarin tablets are currently listed as being in critical short supply. This is, of course, a potentially life-saving drug for persons with cardiovascular conditions.

I'd also like to acknowledge Minister Butler's office for responding to several questions that I had in relation to portions of this bill. However, I must raise some concerns relating to what appear to be extraordinary powers to be granted to the secretary in this bill without, I believe, sufficient ministerial oversight.

The amendments in this schedule are intended to address the gap in the range of measures available under the act to alleviate the effects of shortages—which is fair enough—by amending section 19A of the act to introduce a mechanism to enable the secretary to approve the importation or supply of an unapproved medicine that is principally similar to a medicine that has been cancelled or suspended from the register. Let's just say, as an example—let's just throw one out there—that the secretary wants to substitute a certain medication with, I don't know, a novel technology. What would be the chances, for example, of indemnity being granted to said sponsor? Will there be any guarantees that to substitute is both safe and effective? What if there was to be a safety signal? What happens then? Would the data and rationale behind the decision be disclosed for the public to review? I think we all know where this could potentially go.

We know that there exists a presumption of commercial-in-confidence of information provided by pharmaceutical companies. We know that already. There must exist an obligation for transparency of data and agreements, because, as we all know, transparency builds trust. In our correspondence with the minister's office and the TGA around section 19A, the TGA advised that before a section 19A approval is given the secretary must be satisfied that an approval is necessary and in the interests of public health and that the registered medicines could act as a substitute if the overseas registered goods are unavailable or in short supply. Now, 'in the interests of public health'—we've all heard that before. I wonder what could happen there?

I can think of quite a few recent examples where measures were put in place in the interests of public health but arguably resulted in quite a bit of harm being done. Let's go through them: mask mandates, school closures, lockdowns, vaccine mandates, border closures, curfews and interference with the doctor-patient relationship. There are quite a few. Many failed dictates have been put in place in the interests of public health.

I know this bill is not specifically linked to pandemic measures. I know that. But the overreaches are symptomatic of absolute power leading to poor decision-making and significant unintended consequences. I aim not to stand in the way of large portions of this bill which are necessary. But section 19A is one that needs more attention. I've touched on just a small portion of this bill, and there are many reasons that we should, in the public interest, debate the bill at length. I'll be proposing amendments to this bill. One is proposing referral to the Community Affairs Legislation Committee and another is requesting ministerial responsibility for the decisions made by the secretary as a legislative instrument.

It is unacceptable that we should award great power to a bureaucrat who has no direct accountability to the Australian people. The Australian people can't vote a secretary out at a general election. What I seek is greater transparency, accountability and disclosure of information so we don't repeat the mistakes of the past. Power must be decentralised, decision-making must be transparent and, above all else, the Australian people should be well informed. That is why this bill needs proper scrutiny. For that reason I foreshadow that I'll be moving a second reading amendment at the end of this debate.

Malcolm Roberts (Queensland, Pauline Hanson's One Nation Party) Share this | Link to this | Hansard source

As a servant to the many different people who make up the amazing Queensland community, I speak to the Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022. It's significant that in my speech's opening I refer to myself as a servant of Queensland and Australian people. Whoever wrote this bill is not a servant to the people but in fact sees the people as their servants—no, slaves; serfs. The bill destroys fundamental human rights, smashes fundamental principles of law, removes the tried and true system for authorising new drugs and places the Australian public at the mercy and under the control of unelected bureaucrats. These same bureaucrats proved themselves unfit to exercise their current power during COVID.

First let me explain the provisions of the bill. The first one is 'introducing a framework for the mandatory reporting of adverse events involving medical devices, principally by hospitals'. This has its origin in the pelvic mesh scandal.

Debate interrupted.