For most people, the decision to have children is highly personal—one that's governed by the individuals involved. But couples or women who turn to fertility treatment often find themselves enveloped in a complex and inconsistent web of rules and regulations. It's a web that UTS Law researchers, professors Jenni Millbank, Isabel Karpin and Anita Stuhmcke, are determined to untangle.
However, some states have their own more stringent legislation that limits families to storage periods as short as five years; limits on the number of women who can access donor gametes or embryos, therefore creating a regulatory environment that unfairly discriminates against women in same-sex couples; and destruction protocols that give people little to no control over embryo disposal once patients have completed their families.
"There's a profound disrespect, I think, in law, for how intimate a process fertility treatment is," says Professor Millbank.
"It's a health treatment but it's a very particular type of health treatment, because it's about family building."
Millbank, Karpin and Stuhmcke have long advocated for an approach to legislation and regulation that is informed by end user needs and experiences. Their work spans the breadth of assisted reproduction, from IVF and surrogacy to the complexities surrounding gamete donation, the rights of children born from donated gametes and privacy issues as they relate to donors.
The overarching approach that guides the team's research is a focus on responsive regulation. In a health care context, that means setting rules and guidelines to make health care safer for, and more responsive to, patients—in this case, people undergoing fertility treatment. The researchers also advocate for regulation that recognises the subjective patient experience: that what embryos mean to the users themselves should hold more weight than arbitrary rules and limits.
"Historically, legal regulation was quite paternalistic and imposed very much from above. It's only really been through this century that people have said, gosh, this is actually a technology that's used by a huge number of Australian families who need to have some say over how it operates and how it's regulated," Millbank says.
Millbank, Karpin and Stuhmcke have produced a body of work that has driven substantial changes in the current NHMRC Ethical Guidelines on Assisted Reproduction and influenced every major national and state law reform inquiry on assisted reproduction, surrogacy, genetics, and fertility in the period 2011-2016. In delivering a more adaptable and equitable approach to legislation and regulation, the research has had a profound impact on industry regulators, fertility clinics, lawmakers and—most importantly—families themselves.
Changes to NHMRC guidelines include removing the maximum gamete/embryo storage donation and permitting patient involvement in the embryo disposal process. The guidelines now also contain broader considerations of the impact of disability in existing criteria for pre-implantation genetic testing, a newly-introduced staged approach for patient consent and information-giving in IVF, and advice about overseas treatment, among other substantial revisions.
Reforms to state legislation include the implementation of open-ended gamete and embryo storage limits in NSW, as well as a five-year extension storage extension option in Victoria and a more flexible approach to storage extension requests in WA. Same-sex female couples in NSW can now use the same donor for their children without being counted twice; a review of family limits is currently underway in Victoria.
The research has also contributed to a raft of other regulatory and legislative changes, including providing donor-conceived people with access to a broader range of non-identifying information about their donor, expanded access and eligibility rules for surrogacy in South Australia and Tasmania, and the introduction of transitional arrangements for overseas commercial surrogacy arrangements in NSW.
"Often, we think about the law as an abstract concept, rather than a series of ideas that have a direct and meaningful impact on our lives," says Associate Professor Mike Ford, Assistant Deputy Vice-Chancellor (Research) and the Strategic Initiative Coordinator for the strategic initiative Transforming society through connected research.
"At its core, research impact is about making a positive contribution to the way we live, and this work is a stellar example of how the law can—and should—be used to better respond to the needs of our community."