Prof. Dianne Nicol1
1University Of Tasmania, , Australia
Biography:
Dianne Nicol is a Distinguished Professor Emerita at UTAS. Dianne’s research focuses on governance of genomics and stem cells. Dianne was Australian Embryo Research Licensing Committee chair for six years. However, this presentation relates solely to her role on an MRFF Stem Cell Mission Project led by Rachel Ankeny
Abstract:
The creation of stem cell-based embryo models (SCBEM) is testing the boundaries of regulatory regimes. The complexity of these SCBEM varies making them more or less like human embryos. In this presentation, the Australian approach to SCBEMs regulation is compared and discussed against the UK’s recent Code of Practice for the Generation and Use of Human Stem Cell-Based Embryo Models (created by Cambridge Researchers).
In Australia, the Research Involving Human Embryos Act 2002 (Cth) and the Prohibition of Human Cloning Act 2002 (Cth) share a broad definition of ‘human embryo’ that extends from a human oocyte fertilised by a human sperm to cover other processes that ‘initiate organised development’. The impact of the definition is that the embryo licencing regime will apply to some SCBEM, as confirmed by recent supplementary guidance in Australia.
In contrast, the UK embryo models have fallen outside of National legislation. In this unregulated space, the new code of practice applies to SCBEMs. The code aims to provide oversight to all SCBEM on a case-by-case basis with governance oversight proportionate to the complexity of models. However, in public deliberation related to the Code, many participants suggested that guidelines were an interim step to hard law.
Australian law provides hard lines often desired by the public. Further, although Australian law may require supplement guidelines and might benefit from reflexive reform, there is little reason to develop a separate regime for SCBEMs. The Acts have broadly stood the test of time and will regulate the most controversial SCBEMs.