Denise Cullen
Around one in every 20 babies in Australia are now born using some form of assisted reproductive technology (ART) which could only come about via embryo research, and that proportion seems only set to grow as people start families later in life.
The techniques used in ART involve creating multiple embryos – but when only two or, at most, three are transferred at one time, that results in a number of “spare” or “surplus” embryos which may be cryopreserved for a later “frozen” embryo transfer.
Alternatively, they may be discarded, donated, or provided for research purposes, including human embryonic stem cell research – a practice opposed by some on various religious and moral grounds.
What legislation governs the use of human embryos in research?
In December 2002, the Australian Parliament passed the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002.
This legislation prohibits certain practices, including human cloning for reproduction.
It also regulates the use of excess human embryos created through assisted reproductive technology (ART), the creation of embryos by other means and the use of such embryos in research.
The Acts demand stringent conditions before human embryo research can occur.
The use of embryos for the derivation of human embryonic stem cells – used by researchers seeking to regenerate or repair diseased tissues and organs – is similarly constrained.
Such research may only involve embryos that are “excess” ART embryos and, unless a statutory exemption applies, a licence must be obtained.
In 2022 the Research Involving Human Embryos Act 2002 was amended to facilitate the staged introduction of mitochondrial donation into Australian ART practice.
Mitochondrial donation is an assisted reproductive technology (ART) that can assist women to avoid passing mitochondrial DNA disease (which can be severe or life-threatening) onto their biological child.
Read more: Embryo research raises questions
Who grants licenses for research under this legislation?
The National Health and Medical Research Council (NHMRC), through the work of the Embryo Research Licensing Committee, is responsible for administering both Acts.
As such, it considers general and mitochondrial donation applications for licences to conduct research involving human embryos; issues licences (subject to conditions); maintains a public database; and reports to Parliament on both the legislation and the licences issued under it.
The nine-member Committee is made up of individuals with expertise in research, research ethics, assisted reproductive technology, law, consumer health issues, the regulation of assisted reproductive technology, and embryology.
“Members of the Embryo Research Licensing Committee are exceptional and recognised leaders in their research area, or in the community and consumer domain,” an NHMRC spokesperson said in a statement.
They are appointed by the federal Minister for Health and Aged Care.
“They bring a diverse range of views and expertise that ensures robust and comprehensive decision making by the Embryo Research Licensing Committee,” the spokesperson added.
The NHMRC recently sought nominations for people with appropriate expertise to join NHMRC’s Embryo Research Licensing Committee (ERLC) for the 2024–2027 triennium. It’s chaired by Professor Diane Nicol (All members are listed below from NHMRC website.)
Professor Dianne Nicol holds the title of Distinguished Professor Emerita and is a member of the Centre for Law and Genetics at the University of Tasmania. A Professor of Law with a doctorate in biology, Professor Nicol brings a multi-disciplinary approach to her research, which spans legal, research ethics and social issues associated with genomic data sharing and regulation of innovative and emerging health technologies.
From NHMRC website
Members of the Embryo Research Licensing Committee for the 2024–2027 triennium will be published on the NHMRC website after they have been appointed by the Minister.
Members meet regularly to consider licence applications and variations, to consider compliance issues and discuss issues related to its regulatory responsibilities.
However, details of their discussions remain confidential.
Professor Lynn Gillam is a Professor in Health Ethics at the University of Melbourne and the Academic Director, Children’s Bioethics Centre, Royal Children’s Hospital. A clinical ethicist trained in philosophy and bioethics Professor Gillam’s research is focused on human research ethics. She is Chair of her University’s Central Human Research Ethics Committee and a member of the Research Ethics and Integrity Standing Committee.
From NHMRC website
“It is an offence under the Research Involving Human Embryos Act 2002 to disclose certain information in relation to the licensing scheme,” the spokesperson said.
“As such, the minutes of the Embryo Research Licensing Committee’s meetings are not publicly available.”
Ms Louise Johnson spent 16 years as Chief Executive Officer of the Victorian Assisted Reproductive Treatment Authority (VARTA). She is a graduate of the Australian Institute of Company Directors, with postgraduate qualifications in management and education, Ms Johnson previously worked as a hospital microbiologist and a science teacher.
From NHMRC website
What’s happened since the legislation was enacted?
In 2004, the first five licences allowing research using excess ART embryos were issued.
Two of these licences were issued to fertility centre Sydney IVF Ltd to improve laboratory conditions for embryo culture and to analyse growth and epigenetic programming.
Another was issued to Melbourne IVF for research to develop testing procedures for unbalanced chromosome errors in human embryos and thus improve IVF success rates.
Adjunct Associate Professor Bernadette Richards is a bioethics and health law expert at the Australian Centre for Health Law Research, Queensland University of Technology and the Adelaide Law School, Adelaide University. She is also a Senior Research Scientist at Singapore-ETH Centre, a joint initiative of the Swiss Federal Institute of Technology and Singaporean National Research Foundation.
From NHMRC website
Very few licences have been granted since the legislation was introduced. The public database (at 12 February 2024) records four current licences and 20 expired licences.
How is compliance enforced?
The Committee also monitors licensed activities and ensures legislative compliance.
Professor Sarah Robertson is a NHMRC Investigator Grant Leadership Fellow with the University of Adelaide. Prior to assuming this role in April 2021, she spent eight years as Director of the university’s Robinson Research Institute, which specialises in research into the reproductive and early life origins of health and disease.
Professor Steve Robson is a specialist obstetrician and gynaecologist with a special interest in reproductive medicine and surgery. He is a Visiting Medical Officer for ACT Health and a Professor of Obstetrics and Gynaecology at the ANU Medical School and a past-President of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
From NHMRC website
“(This) involves the appointment of inspectors and the conduct of a range of monitoring and compliance activities,” the spokesperson said.
Inspectors are appointed by the chair of the Committee; appointees are Commonwealth or state government employees with relevant qualifications.
“The Embryo Research Licensing Committee oversees an annual licence monitoring and compliance plan, comprising onsite inspections, videoconference monitoring meetings and review of licence holder input to the six-monthly reporting process,” the spokesperson said.
Professor Patrick Tam is Deputy Director and Head of Embryology Research Unit at the Children’s Medical Research Institute, and Professor in the School of Medical Sciences, Sydney Medical School of the University of Sydney.
Ms Cal Volks is a PhD candidate at La Trobe University Law School and a previous Director of the University of Cape Town HIV/AIDS, Inclusivity and Change Unit, in Cape Town, South Africa.
A social science researcher and counsellor, Ms Volks works with the Victorian Assisted Reproductive Treatment Authority.
NHMRC website
“The plan is developed and executed on a risk management basis.”
Licence holders are required to report to the Committee every six months on their use of excess ART embryos or human eggs or the creation and/or use of other embryos under licence.
Reports are due within 30 days of the end of the reporting period and extensions are not provided.
Licence holders are advised of the content and timing of reporting obligations prior to the commencement of a licence and reminded at regular intervals during the period a licence is in force.
“(The Committee) takes a contravention of licence conditions seriously and considers them as they arise,” the spokesperson said.
For example, on 18 December 2019, Licence 309723 held by Melbourne IVF was suspended due to an administrative breach (late notification of change to principal supervisor status).
It remained suspended, with no activity permitted, until the licence expired on 19 December 2020.
“NHMRC is not able to comment on the internal business decisions of licence holders,” the spokesperson said.
Dr Carol Wicking is a Director at Rare Voices Australia (RVA), the peak advocacy body representing those living with a rare disease in Australia. She is also a member of RVA’s Scientific and Medical Advisory Committee, and was chair of this committee from 2017-2021. Dr Wicking is an Honorary Associate Professor at the Institute for Molecular Bioscience at the University of Queensland.
Members of the public may also submit “allegations of non-compliance forms”.
However, the Committee declined to report upon the number received each year, or the proportions that were substantiated.
“Any information concerning alleged non-compliant conduct with the Research Involving Human Embryos Act 2002 or the Prohibition of Human Cloning for Reproduction Act 2002 is treated in the strictest confidence,” the spokesperson said.
Will the creation of synthetic human embryos using stem cells change anything?
In June last year Professor Magdalena Żernicka-Goetz of the University of Cambridge and the California Institute of Technology revealed at a meeting of the International Society for Stem Cell Research that she and her team had created “synthetic” human embryos.
Created from embryonic stem cells, meaning they do not require eggs and sperm, the finding was hailed as paving the way towards a better understanding of the impact of genetic disorders and the biological causes of recurrent miscarriage, without using early embryos for research.
However, the Research Involving Human Embryos Act 2002 and Prohibition of Human Cloning for Reproduction Act 2002 define a human embryo as “a discrete entity that has arisen from… (b) any other process that initiates organised development of a biological entity with a human nuclear genome or altered human nuclear genome that has the potential to develop up to, or beyond, the stage at which the primitive streak appears, and has not yet reached 8 weeks of development since the first mitotic division”.
“Any entity, (such as) an embryo model created using stem cells, that meets the definition of a human embryo is regulated by the legislation,” the spokesperson said.
“Researchers may apply to the Embryo Research Licensing Committee for a licence to undertake activity involving the use or creation of human embryos,” the spokesperson said.