Oh, baby: The future of Artificial Reproductive Technology

Innovations in assisted reproductive technology (ART) are helping more people realise their hopes of becoming parents. As the technology advances, demand continues to grow, which underscores the need for treatments that are accessible, safe, and reliable.

But ART doesn’t operate in a purely medical space. Instead, it exists at the intersection of science, emotional vulnerability, and a highly commercialised industry. This complexity demands clear rules and strong safeguards. Recent incidents, including two embryo mix-ups at Monash IVF, highlight the serious consequences of failure and reinforce the need for nationally harmonised, government-led regulation to protect patient safety and public confidence as the industry evolves.

ART has become a core component of Australia’s health infrastructure. For many individuals and couples, in-vitro fertilisation (IVF) or other forms of ART represent the only pathway to parenthood, offering a chance to realise deeply held hopes of starting a family. Its personal impact is profound, touching thousands of lives each year and reshaping what’s possible for people facing fertility challenges. Today, one in every 18 babies born in Australia is conceived through IVF, which is an extraordinary testament to the scale and significance of ART.

As fertility rates continue to decline and more Australians delay parenthood, ART is also playing a growing role in demographic planning, supporting population sustainability, workforce participation, and long-term economic resilience. Recognising this dual impact – deeply personal and systemic – there is a clear imperative for health departments to position ART as a strategic priority, with regulatory and funding settings that reflect its expanding role in the future of care.

As the sector expands, so too does the responsibility to ensure that it is underpinned by strong, consistent regulation. Patients undergoing ART place immense trust in their providers, entrusting them with their genetic material, their reproductive hopes, and often significant financial investment. That trust must be safeguarded by systems that are transparent, accountable, and designed with safety at their core.

Recent incidents, like those mentioned above, underscore the profound personal impact when systems fail. While most providers are committed to high standards of care, the current patchwork of oversight, split across federal, state, and territory lines, can lead to variability in standards, reporting, and accountability. Strengthening regulatory safeguards and promoting a nationally consistent approach is a critical step in reinforcing public confidence and ensuring that all Australians can access ART services with trust and assurance.

Australia’s ART sector is subject to a mix of federal and state-based regulation. All states, with the exception of the Australian Capital Territory and the Northern Territory, have specific legislation in place to regulate ARTs. These frameworks share several common features: they require ART providers to be accredited, set eligibility criteria for patients, regulate the use of donor gametes, mandate clinical standards, impose storage limits for embryos, and require the maintenance of detailed records.

However, despite these shared elements, the system lacks national consistency and the obligations and opportunities to access ART differ across jurisdictions. This creates equity challenges for patients and operational complexity for providers who must navigate varying requirements across state borders.

Beyond establishing a common ‘floor’ to ART provision, the lack of national reporting arrangements such as a national donor register means it is difficult to track genetic siblings across jurisdictions, complicating efforts for individuals seeking to connect with biological relatives. There are also challenges coordinating regulatory responses to issues such as so-called super donors, who donate to multiple families, often beyond limits set at a jurisdictional level. 

There is also a need to calibrate regulatory frameworks to better balance safety and access. Currently, the thresholds for market entry as an ART provider, such as licensing requirements and clinical governance expectations, vary significantly between jurisdictions. In some states, such as Victoria and New South Wales, providers must meet detailed legislative standards. In others, such as the Northern Territory and Tasmania, and in Queensland prior to 2024, entry was governed more loosely through voluntary codes or professional guidelines. These inconsistencies can allow gaps in safety protocols or accountability.

Similarly, criteria for patients to access ART services, including age limits, medical eligibility, and counselling requirements, are not uniform across the country. This means that a patient eligible in one state may face barriers in another, raising equity concerns and complicating continuity of care.

Finally, there is evidence that even where regulation exists, implementation can fall short. Recent embryo mix-ups have raised concerns about how frameworks are applied in practice. In Queensland, a patient was mistakenly implanted with another woman’s embryo, a mistake discovered only months later. In Victoria, a separate incident involved the wrong embryo being transferred to a patient. These cases underscore that even in jurisdictions with strong legislative frameworks, legislation alone is not enough - Effective regulation requires consistent implementation, strong clinical governance, and mechanisms for system-wide learning. Without these, even well-designed frameworks may fall short in preventing errors or ensuring accountability.

Strengthening regulation means understanding the health system as it operates in practice, redesigning outdated legislative frameworks, and ensuring regulators are equipped to act strategically and transparently. Three areas of focus are essential:

1. Commit to be part of a solution. Access to high quality ART is important and any government intervention needs to be borne from a want to minimise harm – but it must not create unnecessary barriers to service delivery. Governments must work with service providers and consumers to understand what is working, what is not, where there are risks and how they can be best managed – whether through a regulatory response or otherwise.
2. Get the legislative foundations right. Many of the laws governing ART are outdated and not well suited to today’s risks, such as complex donor arrangements, evolving technologies, and cross-jurisdictional service delivery. First-principles reviews can help clarify the purpose of regulation, identify where national consistency is essential (e.g. donor tracking, clinical standards, patient eligibility), and determine where local flexibility adds value. This is also an opportunity to ensure that legislative frameworks are proportionate, inclusive, and capable of supporting safe, high-quality care across diverse settings.
3. Respond decisively to risk and build public trust. In a sector as sensitive as ART, public trust is critical. Regulators must be able to act quickly and credibly in response to high-profile incidents, using their powers strategically and focusing effort where it matters most. This includes better use of data to detect emerging risks, more targeted compliance strategies, and exploring the responsible use of AI to support smarter monitoring and enforcement. These tools can help regulators work more effectively in resource-constrained environments while maintaining transparency and accountability.

Regulation in the health sector demands a careful balance between patient care and human rights, clinical scope and commercial realities. Reviews grounded in first principles can help reshape regulatory frameworks to address contemporary risks, as seen in recent work across IVF and maternity care at both national and jurisdictional levels.

There are moments when national harmonisation adds value, and others when local flexibility proves more effective. For regulators facing resource constraints, refining the regulatory approach is essential: clarifying where to focus effort, how to use powers strategically, and how to responsibly harness AI to identify emerging risks and support compliance.

The recent announcement by health ministers of a nationwide review into IVF regulation signals a shared commitment to modernising oversight in this space. Ultimately, the goal is to create a system that works for the people at its heart: patients, providers, and communities.

Get in touch to discuss Artificial Reproductive Technology and the future of women’s health.

Connect with Lauren Ware, Charlotte Caro, and Emily Ryan on LinkedIn.

This is the third article in our series on the future of women’s health. Read the first parts here and here.