Should Australian laws regulating embryo research be reformed? A call for commonwealth review

Legal framework

In 2001, a parliamentary report recommended implementing a regulatory regime to allow some activities involving human embryos and to prohibit others.¹ Subsequent parliamentary debate unanimously supported prohibiting human cloning but was less united on the use of embryos for research. Ultimately, legislation was passed in 2002 which allowed certain uses of embryos for research under licence from the National Health and Medical Research Council (NHMRC) Embryo Research Licensing Committee (ERLC).² Major amendments in 2006 extended the range of permissible research activities.³

The current regime recognises two classes of embryos: (1) those arising from fertilisation of an oocyte by a sperm and (2) those created by other means (Box 1). The creation of the first type is prohibited outside of IVF, although surplus embryos may be used for research with consent and under licence. The second type of embryos may be created and used for research under licence. A licence does not permit either embryo to develop beyond 14 days, which is the time when the primitive streak usually appears. The primitive streak is a structure that emerges early in an embryo’s development and establishes bilateral symmetry.

The ERLC is responsible for interpreting the statutory definition of embryo. It has had two opportunities to consider whether SCEMs satisfy the legal definition (Box 2).⁴ In one case, it decided a 3D blastoid was a human embryo because it exhibited the morphological features of an intact conceptus, with the capacity to develop the entire suite of embryonic and extraembryonic tissues. In the second case, it decided a 3D gastruloid model did not meet the definition because it lacked the capacity to develop extra-embryonic tissues and was, therefore, not an intact conceptus. Consequently, research involving the 3D blastoid model required a licence, whereas research involving the 3D gastruloid model did not.

Philosophical challenges

Although the ERLC is lawfully empowered and required to interpret the legal definition of a human embryo, the legislation was drafted long before lawmakers could imagine the possibility of SCEMs. This has introduced new definitional dilemmas.

Internationally, concerns have been raised about insufficient regulation of SCEMs in jurisdictions where they are treated the same as any other human tissue.⁵ There is no consensus about how to categorise different types of SCEMs and what makes a SCEM equivalent to, or ‘close enough’ to, an embryo to trigger stricter regulation and oversight. Even if SCEMs are deemed close enough to human embryos to warrant special concern, there is no consensus that the 14-day rule has any moral significance in this context.⁶ Although sometimes framed as a precautionary response to potential sentience, the 14-day rule was adopted internationally (and in Australia) as a pragmatic limit reflecting international standards and was aimed at allaying public anxiety.^7,8 Due to the lack of functional neuronal connections or sensory systems, it is impossible for embryos to experience sentience, pain, or suffering at 14 days.^6,9 Thus, it has been argued that the original sentience-based rationale for this limit does not withstand empirical scrutiny.⁶ Furthermore, both embryos and SCEMs could be genetically altered to avoid pain and awareness.⁵ However, there remains some support for this limit, as the rationale for removing it could justify more problematic research and potentially undermine public trust.¹⁰

To reform or not

Supporters of the current regime argue that it has successfully preserved public trust and allowed ethical research to proceed for over 20 years. The laws were a product of wide community consultation and reflect a balance between innovation and precaution. Opponents, however, suggest that technological advancements have outpaced the current legal framework. The last comprehensive review was undertaken in 2005, followed by another in 2011.^2,11 The 2005 review resulted in amendments to the legislation commencing in 2006. The 2011 review attracted far fewer public submissions, and its recommendations were not implemented by government.

Reformists propose the legislation should be amended to account for the existence of SCEMs, to clarify definitions, and to avoid any interpretive confusion on the part of the ERLC. A review would also enable an assessment of changing public views and values about embryo research in this evolving scientific field.

Public attitudes

The last surveys directly measuring Australian attitudes to human embryo research were published over 10 years ago.^12–15 A survey published in 2019 focusing on genome editing of human embryos found Australians were comfortable with it if conducted for research only (i.e. not for reproductive use).¹⁶ Another 2018 study involving a panel found that most people were very supportive of research on human embryos.¹⁷

An Australian citizens’ jury in 2021 revealed some unease about creating human embryos for research, although SCEMs were not discussed. While recognising the potential for good, some participants were concerned about misuse and commodification of embryos. The majority concluded embryo research should continue under strict regulatory oversight and the 14-day limit.¹⁸

Two recent international studies surveyed attitudes to extending the 14-day rule. A Japanese survey of 2023 found that 46.2% of researchers and 37.9% of the public agreed the limit should be extended.¹⁹ A 2023 survey of the UK public found that over 40% of the public supported the use of human embryos for research, and over 50% felt the 14-day rule was appropriate.²⁰ Recent UK-based public dialogues indicate that some oversight of SCEM research is needed.^21,22 However, there were divergent views about extending the 14-day rule. Participants felt strongly that any potential changes should be made in consultation with the public.