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Thursday, 2 December 2021
Page: 7151

Senator CASH (Western AustraliaAttorney-General, Minister for Industrial Relations and Deputy Leader of the Government in the Senate) (17:00): I table a revised explanatory memorandum relating to the Mitochondrial Donation Law Reform (Maeve's Law) Bill 2021 and move:

That these bills be now read a second time.

I seek leave to have the second reading speeches incorporated in Hansard.

Leave granted.

The speeches read as follows—

Biosecurity Amendment (Enhanced Risk Management) Bill 2021

The COVID-19 pandemic has tested Australia's human biosecurity systems in an unprecedented way. It has highlighted the rate at which a biosecurity threat can spread between countries and around the world. The spread of exotic pests and diseases is putting unprecedented pressure on our border, and our biosecurity system must continue to evolve to keep pace with these new threats.

Through this pandemic, international maritime vessels have emerged as a significant risk pathway for biosecurity threats to enter Australia. This Bill will amend the Biosecurity Act to provide an improved framework to assess and manage incoming vessels and aircraft where infectious disease risks have been identified on board. These amendments are consistent with recommendations made by the Inspector-General of Biosecurity in his review of the Ruby Princess cruise ship incident, which I commissioned.

The Bill will expand pre-arrival reporting requirements, ensuring accurate and up-to-date information is available to assess the human health risk of arriving vessels and aircraft. It will also expand and strengthen penalties for operators and persons in charge of aircraft and vessels who do not comply with pratique requirements.

It will also provide a mechanism to manage groups of people, such as on board a cruise ship, where passengers or crew display signs or symptoms of a listed human disease, or have been exposed to such a disease. In these circumstances, human biosecurity officers will be able to effectively assess and manage the risks of that disease spreading or entering Australia.

We all look forward to the safe reopening of Australia's borders and this Bill will play an important part in supporting this by reducing the potential for the entry, emergence, establishment and spread of listed human diseases while facilitating a critical step towards a national economic recovery following the COVID-19 pandemic.

Currently, Australia is one of the few countries in the world that is free of serious pests and diseases. This means our current biosecurity system is serving our country well. It has been instrumental in successfully protecting our $51 billion agriculture export industries, our unique environment, our native flora and fauna, and our way of life.

However, Australia's biosecurity system is facing growing regional and global threats such as African Swine Fever and hitchhiker pests like khapra beetle and Brown Marmorated Stink Bug. Higher mail and cargo volumes and complex supply chains, together with the anticipated return to growing international passenger arrivals, increase the opportunities for pests and diseases to enter Australia. The constantly evolving biosecurity environment and risk profile has heightened the need for enhanced risk management to respond effectively to emerging biosecurity risks and future challenges.

This Bill will enhance the ability of the Biosecurity Act to meet these challenges. It will increase transparency and efficiency of administrative processes in the Biosecurity Act, such as those involved in conducting a risk assessment for the purposes of making certain determinations or granting an import permit. The Bill will also introduce into the Biosecurity Act a framework to provide legislative authority to the Agriculture and Health Ministers to make, vary and administer arrangements or grants for expenditure in relation to biosecurity-related programs and activities such as the National Citrus Canker Eradication Program that successfully eradicated the citrus canker outbreak in the Northern Territory and saved Australia's $800 million citrus industry.

The Bill will also amend the Biosecurity Act to increase certain key civil and criminal pecuniary penalty provisions to promote deterrence and enable a proportionate response, reflecting the seriousness of the contravention of these provisions and the consequences that may result from non-compliance. The increased civil penalties introduced by this Bill will serve as a significant deterrent to anybody considering undermining our biosecurity laws and the criminal penalties will allow a proportionate and appropriate punishment for contraventions of the Act.

This Government is committed to continuous improvement across our world leading biosecurity system. That is why this Government announced funding of over $400 million for biosecurity in the 2021/22 budget. The Biosecurity Act is the central pillar of our defence against current and emerging biosecurity threats, and this Bill will enhance our biosecurity framework by improving the efficiency and administration of the Biosecurity Act.

This Bill ensures continued protection for agriculture, tourism and other industries, plant and animal health, the environment, and our market access while providing a stronger biosecurity risk management framework and contributing to a safe reopening of Australia's international borders.



This Bill amends the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002 to make mitochondrial donation legal in Australia.

This Bill will allow women to have a biological child in a way that minimises the risk of transmission of the insidious effects of mitochondrial disease. A disease for which there is no cure - and that leaves children suffering from seizures, fatigue, multiple organ failure and heart problems. In severe cases, even premature death.

Here in Australia, each year around 56 children are born with a severe form of the disease. This equates to approximately one child per week. The tragic prognosis for these children, and their families, is that many will die within their first five years.

Maeve Hood is one of these children. Maeve's family is one of these families. This Bill has been named in honour of Maeve Hood and the tireless work of her family to raise awareness and build support for those people in our community suffering from mitochondrial disease. It has been named the Mitochondrial Donation Law Reform (Maeve's law) Bill 2021.

Maeve has a severe type of mitochondrial disease that was diagnosed at 18 months. She's a bright and bubbly young girl ┬Čbut she suffers from serious medical issues. Maeve is thankfully still with us, but her future looks bleak.

The Australian Government is committed to helping parents, such as Sarah and Joel Hood, to avoid the heartache, pain and anguish of having a biological child with severe mitochondrial disease. Advances in reproductive technology now mean we can help, by providing those families at risk of passing on the disease with a pathway to having a healthy biological child. This Bill, Maeve's law, provides that pathway.

The science underlying this reproductive technology is complex and new, however it is not untested. Mitochondrial donation is an umbrella term for IVF-based reproductive technology which prevents mitochondrial disease being passed on from a mother to her child, with the assistance of a donor. Mitochondrial donation cannot, however, be used to cure people with existing mitochondrial disease nor can it prevent mitochondrial disease caused by an individual's nuclear DNA.

It has been legal in the United Kingdom since 2015 and so we have looked to the experiences of the UK in designing this Bill. However, we have also carefully considered how this technology can be delivered within the existing frameworks of the Australian health system. To help inform our approach, we have consulted widely in Australia over several years.

In 2018, the Senate Community Affairs References Committee undertook an inquiry into the science of mitochondrial donation. The Inquiry examined the impacts of mitochondrial disease, and the legal and ethical considerations associated with mitochondrial donation. The final report recommended further consultation with the community, relevant experts and the states and territories before the introduction of this technology into Australia. Over 2019-2020, the National Health and Medical Research Council (the NHMRC) undertook a series of consultation activities, engaging with a broad range of experts as well as the broader community.

Together with lessons learnt from the UK, the outcomes from these Inquiries have shaped this Bill. Both identified significant support for the legalisation of mitochondrial donation from clinicians, scientists and advocacy groups.

The Bill outlines a carefully staged pathway toward the legalisation of mitochondrial donation in clinical practice. This pathway balances the significant benefits of enabling impacted families access to this new technology and have healthy babies free from severe disease, with both caution and safety provided by an appropriate regulatory framework.

The first stage will initially allow for lab-based research and training. This will be followed by allowing some families to access the technique as part of a trial at one carefully selected, licenced and Commonwealth funded clinic. This trial will help determine the safety, efficacy and feasibility of the technology preventing serious mitochondrial disease being passed from mother to child.

The trial clinic will need to demonstrate significant experience and expertise in mitochondrial disease and reproductive health. It will also need to demonstrate an ability to provide an equity of access to families, have specialised research and clinical facilities and the expertise to provide appropriate support to all participants.

Should the trial find the procedure to be safe and effective, the Bill contains an option to move to Stage 2, where this new technology will be made available in a broader range of clinical settings. However, progression to Stage 2 will be subject to a separate decision by government. It will be informed by the outcomes from the trial, expert opinion and further community consultation. At this point, states and territories will also have the option of 'opting in' to a national regulatory framework governing the clinical provision of this technology.

The Bill has inbuilt safeguards and protections. It establishes a comprehensive licensing regime to ensure access to this technology is carefully controlled and that the procedure is conducted safely and ethically. Five different categories of licence are provided for in the Bill, corresponding to steps within Stage 1 and Stage 2. Through the process of applying for licences and complying with their conditions, organisations will be closely vetted and carefully overseen by the NHMRC.

The two-stage approach provided for in this Bill was outlined in a discussion paper released in February this year. Public consultations on this have just closed. Overwhelmingly, the Government heard strong support from experts and from those in the community who engaged in the process.

Some members of the community have raised concerns about issues such as privacy of parents and children, creation and destruction of embryos, ensuring informed consent, donor rights, and the newness of the science. I acknowledge that not all members of the community are comfortable with the use of this technology, and that is why a conscience vote will be called for this Bill.

This Bill has been developed in Maeve's honour. Maeve's law will ensure that other children and parents do not have to suffer the devastating consequences of mitochondrial disease - as Maeve, Sarah and Joel Hood have. It will provide parents with the option to have their own biological children free from the burden of this severe disease.

It is incumbent on this Government to give Australian parents the choice and opportunity to have children free from severe disease through the use of reproductive technology and to reduce the burden of disease for future generations. It is also essential that we remain at the forefront of advances in both medical science and reproductive technology. We cannot sit by complacently when the health and lives of Australian children are at stake.

Debate adjourned.

Ordered that the further consideration of the second reading of these bills be adjourned to the first sitting day of the next period of sittings, in accordance with standing order 111.

Ordered that the bills be listed as separate orders of the day.