Monique Ryan (Kooyong, Independent) Share this | Link to this | Hansard source

I move:

That item 12 of the Financial Framework (Supplementary Powers) Amendment (Health and Aged Care Measures No. 4) Regulations 2024 made under the Financial Framework (Supplementary Powers) Act 1997 on 24 October 2024 and presented to the House on 4 November 2024, be disallowed.

I move this motion to disallow the instrument amending the Financial Framework (Supplementary Powers) Act 1997, referred to as the Moderna partnership, tabled by the Minister for Finance in the Senate and then this House on 28 October 2024. The Morrison government struck a deal with Moderna in May 2021 to build a facility in Australia for the domestic production of new vaccines. The Morrison government had failed to procure COVID-19 vaccines in a timely manner. It had lost the vaccine race. It struck a hasty deal without the usual competitive tender so it would be able to announce that it was doing something, knowing full well that that facility would almost certainly be built too late to contribute significantly to the COVID-19 pandemic response. The terms of the deal were kept secret at the time.

We now know that it is a multibillion dollar deal in which taxpayers paid for a facility which is fully owned by Moderna—a facility that has, as yet in 2025, failed to produce a single dose of vaccine for our domestic use. We now know—but only because of the tabling of this disallowable instrument by Senator Gallagher last October—that, as part of the Morrison-Hunt agreement, the government has created a streamlined vaccine procurement process exclusively for Moderna's pandemic and non-pandemic vaccines outside the National Immunisation Program.

The need for pandemic preparedness is still front of mind for all Australians, but this financial arrangement is about more than just preparing ourselves for the next pandemic. It is a commercial leg-up for one company in what is a very competitive non-pandemic vaccine market. This arrangement should be revised to ensure a level playing field for the best Australian and global companies to research, develop and manufacture the best medicines for Australians in Australia. It should be disallowed because it circumvents the standards and safeguards of Commonwealth procurement processes on the grounds of protecting human health when in fact it is to be applied to non-emergency medicines. There is a defined and accepted process for the procurement of medicines and medical treatments in this country. There is no possible justification for non-emergency vaccines sidestepping this process.

The COVID-19 pandemic was the greatest trauma experienced by this country in this century. Thousands of Australians died. Our social and economic life was damaged. Tens of billions of dollars were wasted by the Morrison government on a poorly directed economic stimulus package and on wasteful and opaque spending on diagnostics, PPE and vaccines. We will never know the full extent of that waste, because the Morrison and Albanese governments have refused a royal commission into the management of the COVID-19 pandemic. Without those lessons, we will inevitably be less well prepared for the next pandemic. And so I'm moving this disallowance motion today in the national interest and in the interest of the health of Australians, the health of our economy and the health of the democratic institutions that safeguard the national public interest. I'm moving this motion in the interests of transparency so that a major decision of our government during the pandemic doesn't just slide through this place unnoticed and unquestioned.

Do we welcome the Moderna facility in Australia—Moderna in Australia? Yes, we do. Australia's world-class health and medical research capacity, with which I am personally and particularly familiar, makes us an obvious location for world-class pharmaceutical manufacturing. During the pandemic, Moderna's vaccine development was the fastest ever seen globally. Moderna's mRNA vaccine for COVID saved millions of lives. Do we need to expand our vaccine manufacturing domestically? We clearly do. Right now, only one COVID-19 vaccine is available in Australia. That's Pfizer (COMIRNATY) JN.1. The Albanese government actually decided not to replenish supplies of Moderna mRNA vaccine in late 2024. Those unable to receive mRNA vaccines have been unable to access any form of COVID vaccine in Australia since July 2024, and this has caused a lot of distress to those people who are keen to access the Novavax vaccine. We know that two COVID-19 variants are currently active in Australia. A recent COVID wave affected more than 200 aged-care facilities. Most older Australians have not been immunised for six months or more.

Does government investment in sovereign capability for medicine production domestically make sense? Yes, it does. Our pandemic experience has shown us the risks of global supply chain interruptions, and they've shown us the importance of building expertise and capacity for research and manufacturing onshore and for safeguarding our resources. Australia imports 90 per cent of its medicines. We have ongoing shortages of medicines for ADHD, for diabetes, for palliative care, for HRT, for antibiotics and more. For years, I have been pushing for more support for local medicines production, which we could facilitate through schemes like A Future Made in Australia. But we have no certainty that putting this very large egg in this single basket is going to help our pharmaceutical industry, our vaccines industry, even just our mRNA industry to strengthen and diversify, or that it will provide continuity of local vaccine production before and after this contract expires in 2032. We don't know if the government has looked at other options open to it under the existing facility establishment agreement, such as expanding expenditure for research and development or for manufacturing for research rather than vaccines. These are options which could have significant spillover benefits for Australian medical research capability and for our commercialisation skills.

Do we need to support medical research in Australia? We certainly do, which is why I've been asking the minister to immediately release funds from the Medical Research Future Fund to universities and medical research institutes, which are struggling in a time of decreased local funding for research and development, and at a time when support of Australian medical research by the NIH and other US sources has decreased by $368 million in this year alone.

Why is this deal so concerning? Australia's decades-old system of vaccine procurement ensures that safe, effective and cost-effective vaccines are purchased and provided to the Australian people. The government's arrangement with Moderna is the biggest change to vaccine procurement in Australian history. It gives a massive commercial advantage to one company by making a multibillion contribution to the construction of a new, single facility and to the servicing of its operations, with no transparency as to what, if any, ownership we have of that infrastructure and the ongoing operations of the facility. It gives one single company access to expedited procurement processes, remembering that it takes on average 3.8 years for the PBAC to approve new vaccines in this country. In doing so, this agreement disadvantages other vaccine manufacturers. It creates a disincentive for other companies to invest or expand here. In seeking to build capacity, we are potentially stifling it.

It's wholly appropriate that governments invoke human health considerations during a pandemic. During the COVID-19 pandemic acute phases, both Pfizer and Moderna benefited from alternative health technology assessment processes. We needed those expedited pathways because of the longstanding issues with medical regulatory pathways in this country. Those issues persist. To its credit this government commissioned the health technology assessment review in 2022, but it reported in May 2024, and it's still not scheduling implementation of its recommendations until 2026. That is too slow. We need faster medication approvals. We need to ensure that we are better prepared for the next pandemic. Now is the time to improve the TGA, the PBAC and MSAC, not to build cut-outs for our favoured partners.

We don't know what HDA criteria and assessments will apply to the vaccines produced by this facility. We don't know how they're going to vary from the standard processes. But we do know that the government has actively disapplied the usual rules around competition, value for money, merits review and regulatory impact assessments. And remember that this special treatment is not just for pandemic vaccines. It specifically includes non-pandemic vaccines. There is no possible justification for this carve-out. The usual safeguards for procurement should apply. The usual standards of best product at best value should apply to non-pandemic vaccines produced by the Moderna facility.

Giving a single commercial entity a sweetheart deal undermines competition. Companies which didn't receive taxpayer gifts upfront do not have the same capacity to invest. A business environment characterised by uncompetitive deals is an active deterrent to other companies which might be considering capitalising on Australia's medical research expertise, companies which are considering investing locally in the research and development required to bring new and improved products to our market. A guarantee to a single company to fast-track approvals for their product while their competitors wait three years or more for the same approvals is anticompetitive. It's a deterrent to new research and development, for which we will all be the poorer.

We need our government to always act in the public's best interest, with honesty and transparency. That is more important than ever when it comes to health care. The people in this place should be asking: What is in the best interests of the people of Australia? With this deal from 2021, what is being promised to the Australian taxpayer in 2025 and beyond? How can we guarantee a fair and equal playing field for business investments in this country? How can we encourage research and development and build sovereign capacity for medicine production when we are committing to these sorts of deals? How do we best protect and preserve the health of all Australians?

To that end, I move that this instrument be disallowed, to give the parliament of Australia an opportunity to investigate these really important questions and to act transparently and in the best interests of the health and wellbeing of our constituents.

Sharon Claydon (Newcastle, Australian Labor Party) Share this | Link to this | Hansard source

Is the motion seconded?

Helen Haines (Indi, Independent) Share this | Link to this | Hansard source

I'm pleased today to rise to support and second this very important motion from the member for Kooyong because it goes to the very heart of accountability, transparency and trust that decisions made by government are in the public interest. We should all be very grateful to the member for Kooyong for bringing this issue to the attention of the House. Decisions that were made back in COVID times were decisions that were made under the spotlight, pressure and uncertainty of a global pandemic. We are no longer in that situation. We know that Australians value transparency and fairness in government. This includes procurement and, most especially, spending on health. These values were not swept aside during the pandemic. In fact, they were more important than ever.

During the COVID-19 pandemic, governments across the world made huge asks of their people, and we were no different here in Australia. When governments ask such big sacrifices of their people, governments must also uphold the faith. That means acting with integrity and being open to scrutiny. In this case, we're talking about the deal between the former Morrison government and international company Moderna in May 2021 to build an mRNA manufacturing facility at Monash University in Melbourne under pressure over vaccine supply. I was here in the parliament at that time and there was enormous pressure. The then health minister, Greg Hunt, announced the government would test the market for domestic manufacturing. Only two credible bids emerged: Australia's CSL and the internationally owned Moderna.

By December 2021, the Morrison government had entered into a confidential agreement with Moderna to build the facility. Now, we know very little about this deal. How much are we as taxpayers spending? What are we getting for our money? What guarantees do we have? We were told this plant would be operational by the end of 2024, producing up to 100 million doses of vaccines for COVID, influenza, RSV and more. This was a significant national investment during an unprecedented crisis, but the details were and, alarmingly, continue to be hidden from the Australian public, and the question is: why?

The parliament and the public do not know what Australia is paying, how much vaccine we are guaranteed or on what terms, and that's simply not good enough. This was a decision made by the Morrison government, but, critically, this secrecy continues, now, into this Labor government. In October 2024, the government tabled a legislative instrument creating what it calls the Moderna Partnership. These regulations grant Moderna exemptions from the usual Commonwealth procurement and assessment processes. What we're debating today is whether the parliament should draw back the curtain on the Moderna partnership between Moderna and the Australian government.

It is our role as parliamentarians to ensure scrutiny of governments and the decisions of ministers, and, thanks to the member for Kooyong, that's exactly what we're doing today. It is exactly what this motion is all about. The government has committed to annual minimum purchases of Moderna's vaccines; however, remarkably, those vaccines will not undergo assessment by the Pharmaceutical Benefits Advisory Committee, which, for decades, has ensured Australians receive the safest and best medicines at a fair price. Instead, the government has proposed an independent health technology assessment pathway, but this pathway has not yet been established. So one multinational pharmaceutical company has been granted a regulatory light touch, but this light touch won't be available to Australian firms or, indeed, to other vaccine producers. Why?

Australia's vaccine procurement system is one of the most robust in the world. It ensures vaccines are safe. It ensures they are cost effective, and it ensures Australians can have confidence that their government is acting in the public interest. By exempting Moderna from these longstanding processes, the government risks undermining that very confidence. During the height of the pandemic, extraordinary measures were justified. We needed vaccines fast, and the government rightly used its discretionary powers. But we are no longer in this emergency phase.

The member for Kooyong has pointed out so clearly why we need to be now putting great scrutiny on this very decision. Australians deserve transparency at the very least. At the very least they deserve transparency. They deserve confidence that their government is buying vaccines fairly, openly and, ultimately, in their interests. The government must release the details of this multibillion-dollar deal. It must ensure that all vaccines, regardless of the manufacturer, are subject to rigorous, transparent assessment, and this government must reaffirm its commitment to public money always delivering public health for Australians and not to the financial interests of international big pharmaceutical corporations.

So I am very pleased to second this motion. I support it and I'm very grateful to the member for Kooyong, and every member of this House should be grateful to her, too, for bringing this issue to our attention and demanding of us that we do our jobs and scrutinise this.

Sophie Scamps (Mackellar, Independent) Share this | Link to this | Hansard source

I, too, rise in support of this disallowance motion brought by the member for Kooyong, and I thank her for bringing it to the House. It's not a race—we all remember those four words from the former prime minister Scott Morrison during the COVID-19 pandemic. They symbolised a government that was unprepared and slow to act. So, after failing to promptly secure COVID-19 vaccines for Australians, the Morrison government, under pressure, struck a rushed deal in May 2021 with the US pharmaceutical company Moderna to build a domestic mRNA vaccine manufacturing facility. This was a $2 billion deal done behind closed doors, with no transparency, no scrutiny and no accountability. Not one detail was made public at that time. Even now we don't fully know what taxpayers got for that money. What we do know is this: to date, Moderna has not produced a single dose for the Australian market from its new facility.

The deal bypassed our proven robust systems for ensuring quality, safety and value. Moderna's vaccines were exempted from assessment by the Pharmaceutical Benefits Advisory Committee, or PBAC, the very committee responsible for determining whether medicines are safe, effective and worth funding through the National Immunisation Program. This decision has created a parallel procurement process, exclusively for Moderna: fast-tracked, exempt and unexplained. Yet the Albanese government has forged ahead with it. It's a decision that has drawn serious concern from leading public health experts and regulatory bodies. Professor Peter Collignon of the ANU has said the PBAC process is critical, not just for safety but also to ensure value for money and informed comparison between vaccine options. PBAC chair Robyn Ward warned speeding up distribution must not come at the cost of fairness, access or safety. Australian manufacturer CSL offered to produce vaccines at a lower cost. They recently invested over $1 billion in a Melbourne facility, but they haven't been offered the same fast-tracked regulatory path. This deal puts CSL and other local innovators at a distinct disadvantage.

So we are now at risk of creating two systems for vaccine approval in this country—one for a single foreign multinational and another for everyone else. This is anticompetitive, and it undermines the integrity of Australia's medical procurement processes. Whilst sovereign manufacturing is vitally important for our country, existing safeguards and regulatory checks must not be disregarded. Let me remind the House that this 10-year agreement commits successive governments and taxpayers to purchase Moderna's vaccines for years to come, regardless of evolving science, emerging options or changing needs. The fact that the Australian National Audit Office has launched a formal inquiry into this deal speaks volumes. We are not just talking about vaccines here. This is about how government procurement power should be used to create a healthier population and a stronger economy.

Just last week the government hosted the economic reform roundtable to discuss productivity and innovation, and yet we still have this deal. Our Future Made in Australia has overlooked the health and medical innovation sector, one of our greatest economic opportunities. We have examples of world-leading Australian innovation—Cochlear, ResMed and others—who succeeded because they had access to research support, regulatory integrity and, importantly, fair competition. We must not create a system where one multinational receives preferential treatment while local companies are left to wait three years or more for approval. That is not smart investment; that is a barrier to innovation. The Australian public agrees. Nine in 10 Australians support investment in local companies producing medical products. They want transparency, fairness and sovereign capability, not secret deals. This comes at a time when the government is currently undertaking a strategic examination of research and development to grow our core science and innovation capability. If we are serious about building long-term prosperity and sovereign capability, we must disallow backroom deals that go against these very principles.

This is not about opposing mRNA technology. It has been transformative. But innovation must be supported by a fair, transparent and accountable process—one that ensures competition, builds local capacity and safeguards public trust. We need smarter investment, not secret deals. We need robust systems, not parallel ones. We need to support Australian innovation, not undermine it. For these reasons, I strongly support the member for Kooyong's disallowance motion and thank her for moving it in the national interest.

Scott Buchholz (Wright, Liberal Party, Shadow Minister for Skills and Training) Share this | Link to this | Hansard source

The opposition won't be supporting the disallowance motion, for the reasons that I'll outline. The Moderna 10-year strategy partnership is about sovereign health security, future pandemic preparedness and growing Australia's world-leading medical research sector. It was commenced by the former coalition government, with the support of the Victorian Labor government, and finalised under the Albanese Labor government in August 2022. The agreement will result in Australia being able to make up to 100 million world-leading mRNA vaccine doses per year in the event of another pandemic or health emergency. This provides the capacity and capability to protect against evolving strains of COVID-19 or new respiratory diseases that emerge in the future.

Moderna was selected through a full and exhaustive cabinet process on the basis that it was the only bid that had an existing mRNA vaccine technology. As part of the partnership, Moderna will maintain a world-class facility ready for rapid deployment in the case of future endemic or pandemic threats. The facility will also have the capacity to support Australia with domestically manufactured mRNA vaccines against common seasonal respiratory viruses, pending TGA approval. All vaccines supplied from the facility will need to be approved by the TGA and ATAGI and undergo health technology assessments, as is the case with other vaccines supplied in Australia. It will make critical and regional hubs for mRNA technology development and production, bolstering our local biotechnological sectors.

Successive national governments, the independent Halton review and the COVID-19 response inquiry have all identified the need for sovereign manufacturing capability to respond to future health threats. Moderna, established in Melbourne, enables Australia to be one of the few countries worldwide with end-to-end mRNA based vaccine manufacturing. The final framework regulation gives legal effect to the partnership between the government and Moderna and has been in place since 2022.

I acknowledge the member for Kooyong, but given the agreement commenced under the coalition government which is being implemented by the Labor government with bipartisan major party support, we will not be supporting a disallowance to void this agreement. For companies like Moderna and the pharmaceutical industry across Australia, predictability in government policy is essential, and it provides the certainty needed to invest in Australia, create jobs and grow our medical and research capabilities. The coalition is committed to delivering that sustainability and stability.

Rebecca White (Lyons, Australian Labor Party, Assistant Minister for Women) Share this | Link to this | Hansard source

Firstly, I would like to recognise the member for Kooyong and her deep expertise and professional background that she brings to this place, and I acknowledge that this is something of deep interest to her. However, the government won't be supporting the disallowance, and I'll explain why.

The motion moved by the member for Kooyong seeks to disallow item 12 of schedule 1 to the Financial Framework (Supplementary Powers) Amendment (Health and Aged Care Measures No. 4) Regulations 2024 made under the Financial Framework (Supplementary Powers) Act 1997 on 24 October 2024. The item underpins the government's expenditure on Australia's onshore manufacturing capability and pandemic preparedness. The government supports transparency and accountability. In this instance, there are genuine reasons why the precise details of the agreement between Moderna and the Commonwealth must remain confidential. The fact is that the agreement between Moderna and the government secures more than just vaccines. In supporting the development of a domestic manufacturing capability, the arrangement promotes Australia's sovereign capability, resilience and pandemic preparedness; Australia's onshore production of vaccines using mRNA technology, a technology which was successful in responding to the COVID-19 pandemic; and the enhancement of Australia's research and manufacturing ecosystem and workforce to support our world-class capabilities to develop and produce the next generation of medical technology.

The agreement is a part of a three-way 10-year arrangement, ending in 2032, between the Australian government, the Victorian government and Moderna. It is the reason why Australia is now one of the few countries in the world with an end-to-end mRNA vaccine manufacturing capability.

Like other vaccines—and I think this point will be particularly relevant to the member for Kooyong—vaccines manufactured by Moderna and supplied under the agreement with government must be approved by the Therapeutic Goods Administration for quality, safety and efficacy. These principles will not be compromised—and I want to emphasise this point. The Moderna vaccines must also be assessed by the Australian Technical Advisory Group on Immunisation. Importantly, the vaccines are also subject to an independent health technology assessment, consistent with the Pharmaceutical Benefits Advisory Committee guidelines. These assessment arrangements for Moderna onshore vaccines are the result of significant negotiations between the department and Moderna and are commercial-in-confidence.

The agreement was established in line with the Australian government's legal obligations and policy mandate and completed in accordance with the Public Governance, Performance and Accountability Act 2013. Moderna Australia's manufacturing facility was completed in late 2024, with regulatory approvals now underway. Registration and supply in Australia will only commence following approval of the manufacturing facility and vaccines by the TGA. This is a crucial investment in our domestic manufacture of vaccines in Australia and our preparedness for future pandemics, and, for these reasons, the government will oppose the motion from the member for Kooyong.

Milton Dick (Speaker) Share this | Link to this | Hansard source

The question is that the motion be agreed to.