Regulatory Statement of Expectations and Statement of Intent

Statement of Expectations

Professor Steve Wesselingh
Chief Executive Officer 
National Health and Medical Research Council
GPO Box 1421
CANBERRA ACT 2601

This Statement of Expectations (SOE) details my expectations of how the National Health and Medical Research Council (NHMRC) will achieve its regulatory objectives, carry out its regulatory functions, and exercise its regulatory powers.  

The Australian Government recognises and respects the statutory independence exercised by the Embryo Research Licensing Committee (ERLC) of NHMRC when administering the human embryo research regulatory framework established by the Research Involving Human Embryos Act 2002 (RIHE Act) and the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act).  

The Government also recognises and respects the independence of your role as NHMRC’s Chief Executive Officer and as the agency’s Accountable Authority with responsibility under the Public Governance, Performance and Accountability Act 2013 (PGPA Act) for ERLC’s regulatory functions.  

This SOE supports the delivery of these functions and contributes to the Australian Government's commitment to effective governance and performance of regulatory functions. It takes account of the whole-of-government objective for Commonwealth regulators to effectively balance risk mitigation with efficiency, growth and dynamism; maintaining a commitment to good corporate governance and reducing unnecessary burden on business and the community.  

Overview

The regulatory framework established by the RIHE Act and the PHCR Act, prohibits certain practices, such as human cloning, and regulates the uses of excess human embryos created using assisted reproductive technology (ART) in research. It also regulates the creation and/or uses of other human embryos created through processes other than fertilisation, and the practice of permitted mitochondrial donation techniques in ART research in Australia.

The Australian Government recognises and respects the independence of ERLC in its delivery of regulatory functions under this framework. However, the Government is of the view that all regulators should have a risk-based approach to compliance obligations, engagement and enforcement that allows for proportionate responses appropriate to the nature and seriousness of identified risks.  

This approach recognises that it is not possible to eliminate all risks, whilst enabling regulators to achieve their objectives effectively, including the prioritisation of opportunities for productivity improvements in the regulatory environment.

Regulatory reform

The regulatory reform agenda is a key component of the Government's plan to boost Australia's productivity and lower the cost of living by ensuring a fit for purpose regulatory environment. The Government is looking at ways to boost productivity through reducing unnecessary or duplicative regulatory costs. Cooperating with the states and territories and working with international partners identifies opportunities to improve the quality of regulation and lower the cost of living for Australians.

The Government is also improving regulator performance, capability and culture through regulatory stewardship. This supports the Government's commitment to Australian Public Service reform by building trust in government and its institutions and by putting the community and business at the centre of policy and services.

I expect NHMRC to contribute to the regulatory reform process by:

• embracing a proportionate risk-based approach to regulation to effectively balance risk mitigation with efficiency, growth and dynamism as a priority, and to consider the impact on productivity
• aligning regulatory activities with the 6 principles of the Regulatory Policy, Practice and Performance Framework in a way that is appropriately scaled to the role, regulatory posture, specific legislative objectives, functions, and environment that ERLC regulates
• seeking opportunities to reduce duplication and streamline processes in order to improve efficiency and lift productivity, including international harmonisation or alignment with international regulators, if appropriate
• acting in accordance with regulator best practice in its decision-making, policies, processes and communications practices, including reporting against key performance indicators and, as appropriate, service standards to maximise transparency and minimise compliance costs
• incorporating regulator performance reporting into NHMRC corporate reporting in line with the expectations of Resource Management Guide 128 (Regulator Performance) to support greater transparency and accountability to the Government for regulator performance
• giving consideration of cost recovery arrangements, if appropriate. 

Best practice principles

In exercising its regulatory functions, I expect NHMRC to integrate the principles of regulatory best practice into its functions in an appropriate and proportional way: 

1. Targeted and risk based – providing pragmatic solutions to minimise regulatory burden, while ensuring the regulatory intent is being met and essential safeguards remain in place
2. Integrated in existing systems – utilising a whole-of-system approach by integrating, leveraging, improving, and modernising existing regulatory systems, where appropriate
3. User-centred – applying good regulatory design that solves clear, well-defined problems and fosters changed behaviours, resulting in greater regulatory compliance
4. Evidence-based and data-driven – utilising evidence throughout the regulatory life cycle to predict and evaluate future need and potential challenges, and support the delivery of fit-for-purpose policy, practice, and performance outcomes
5. Reflective of the digital era – take advantage of digital and technology capabilities and practices, where appropriate, whilst ensuring equitable access to regulatory systems
6. Continuously improved and outcomes-focused – maintaining stewardship to evaluate and recommend improvement to regulation, ensuring regulatory systems are transparent and responsive to evolving regulatory environments and shifting expectations from government and community.  

To support an efficient and effective regulatory environment that enables productivity gains, I expect NHMRC to monitor the environment in which ERLC operates to ensure regulatory approaches keep pace with changes in technology, industry practices, international regulation, and community expectations. I also expect NHMRC to regularly review and, where necessary, adjust policies, protocols and operational procedures, to ensure ERLC can respond to the changing social, technological and international regulatory environment and commercial context in which it operates. 

Relationship with Minister and portfolio

As noted earlier, the Government and I appreciate and respect the independence of ERLC in its delivery of the agency’s regulatory functions. I ask that you, as the Accountable Authority, provide me with accurate and timely advice on significant issues that may be impacting on delivery of ERLC’s regulatory responsibilities.

Statement of Intent

I look forward to NHMRC’s reply to this SOE with a Statement of Intent (SOI) outlining how you will implement these expectations. I request that this SOE and corresponding SOI be made available to the Australian community through NHMRC’s website.  

Yours sincerely

Mark Butler 
Minister for Heath and Aged Care
18 December 2025

Statement of Intent 

The Hon Mark Butler MP
Minister for Health and Aged Care
Parliament House
CANBERRA ACT 2600

Dear Minister

This Statement of Intent (SOI) responds to the Statement of Expectations (SOE) dated 18 December 2025. It sets out my intentions regarding how the National Health and Medical Research Council (NHMRC) will support the Embryo Research Licensing Committee (ERLC) to carry out its regulatory functions and exercise its regulatory powers.

The Australian Government has identified better regulation as a key driver in boosting Australia’s productivity, improving economic resilience, and reducing undue burdens on businesses and consumers. This SOI outlines NHMRC’s approach to regulatory stewardship, integrating the principles of regulator best practice and stakeholder relationship management; delivering on the Government’s policy priorities as set out in the Commonwealth’s Regulatory Policy, Practice and Performance Framework (the Regulatory Framework).

Overview

NHMRC is proud to be Australia’s leading expert body in health and medical research. For nearly a century, we’ve been driving innovation, integrity and impact – funding exceptional research, setting national health standards and providing trusted, evidence-based health advice to improve the health and lives of all Australians. Through clinical, public health and environmental health guidelines, NHMRC supports the translation of research into health practice and policy. By providing guidance on responsible research practices and ethical issues, NHMRC fosters the highest standards of integrity in the conduct of research and the delivery of health care.

Our responsibilities extend to the regulation of the use of human embryos in research through administration of the Research Involving Human Embryos Act 2002 (RIHE Act) and the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act). These Acts address community concerns about scientific developments in human reproduction and the use of human embryos in research activities.

The legislation establishes a framework to prohibit certain practices, such as human cloning, and regulates the use of excess embryos created through assisted reproductive technology, along with the creation and uses of embryos created through processes other than fertilisation. Since 2022, these Acts have also regulated the use of certain mitochondrial donation techniques to create human embryos using assisted reproductive technology. The RIHE Act establishes ERLC, a principal committee of NHMRC, as the national regulator of activities defined in the Acts. 

Regulatory stewardship

The careful and responsible regulation of human embryo research in Australia by ERLC reflects community expectations of this legislation. Strong stewardship helps to ensure that the regulation of this research is efficient and effective in meeting its dual objectives of protecting the health and safety of the community, whilst enabling innovative and novel research to occur in Australia.

NHMRC will continue to support ERLC to align its regulatory activities with the 6 principles of the Regulatory Framework in a way that is appropriately scaled to the role, regulatory posture, specific legislative objectives, functions, and environment that ERLC regulates, and to implement their legislated functions in a manner that is consistent with the guidance provided in Resource Management Guide 128 (Regulator Performance) (RMG 128).

Regulatory reform and best practice

Consistent with your expectations, NHMRC recognises the importance of applying the principles of regulator best practice in our activities. Ensuring compliance with national standards and maintaining constructive stakeholder relationships in the regulatory environment. The agency continues to integrate regulatory best practice principles in activities that support delivery of ERLC’s functions.

Targeted and risk based

We embrace a proportionate, risk-based approach; actively seeking to understand, engage with, and effectively mitigate strategic risks to deliver ERLC’s regulatory functions. This includes the identification and implementation of pragmatic solutions to minimise regulatory burden on the research sector wherever possible, whilst acting within the essential community safeguards established by the RIHE and PHCR Acts.

Integrated

We ensure that the policies, protocols and procedures that support the human embryo research framework are reviewed regularly and are proactive in our approach to monitoring and evaluating the framework to ensure remains fit-for-purpose. NHMRC also continues to engage with other Commonwealth regulators, particularly within the Health Portfolio, to learn from their expertise and where appropriate, to help drive improved regulator performance at a whole-of-system level.

User-centered 

We ensure that the regulation of human embryo research in Australia reflects contemporary regulatory practice, with a focus on being open, transparent and consistent when engaging with stakeholders. We engage and consult on significant changes to the framework, are receptive to feedback, and provide clear and accessible guidance and information to assist regulated entities to meet their compliance obligations.

Reflective of the digital era

We maintain essential safeguards, using data and digital technology, wherever possible and appropriate, to manage risks and minimise regulatory burden on applicants. We support those we regulate to comply with, and enhance their understanding of, the requirements of the legislation.

Continuously improved and outcomes-focused

We use quantitative and qualitative analysis to assess regulator and license holder performance, reporting against performance measures in NHMRC corporate documents. We also regularly review and, where necessary, adjust protocols and operating procedures to ensure that ERLC remains agile and responsive to sector needs and promotes a culture that builds public confidence in NHMRC’s activities and trust in government decision-making.

Relationship with Minister and portfolio

I acknowledge your request that I provide you with advice on significant issues that may be impacting on delivery of ERLC’s regulatory responsibilities. ERLC, supported by NHMRC, will continue to monitor the regulatory environment to ensure that, in as far as the legislation will facilitate, the regulatory approach keeps pace with changes in technology, research innovation and community expectations.

In line with RIHE Act requirements, ERLC will also continue to report twice a year to the Parliament of Australia to maintain consistent, timely and transparent engagement with parliamentarians on the performance of its functions and the activities of the licence holders it regulates.

I will make the 2025 SOE and this SOI available on the NHMRC website and ensure that the associated performance measures and reporting are integrated into NHMRC’s corporate reporting processes.

Yours sincerely

Professor Steve Wesselingh 
Chief Executive Officer
19 December 2025