12 April 2017

SA Assisted Reproductive Treatment regime report

The 325 page Report on the Review of the Assisted Reproductive Treatment Act 1988 (SA) [PDF] responds to terms of reference that require the reviewer to
evaluate the operation and effectiveness of significant changes made to the Act in 2010, which had a legislative requirement for review after five years. The changes included:
1. the replacement of the previous licensing scheme with a registration scheme for clinics providing assisted reproductive treatment (A.R.T.);
2. the dissolution of the SA Council on Reproductive Technology and its Code of Ethical Conduct;
3. the requirement that the welfare of any child born as a consequence of A.R.T. is to be treated as being of paramount importance, and accepted as a fundamental principle, in respect of the operation of the Act, as well as in the provision of A.R.T.;
4. allowing for the establishment of a donor conception register;
5. amending eligibility for access to A.R.T. services—noting that such conditions relate to the circumstances in which, and to whom, A.R.T. may be provided; and
6. provisions regarding record keeping and confidentiality.
The report features the following summary
Chapter One: Introduction
The review of the Assisted Reproductive Treatment Act 1988 (SA) was concerned with the operation and effectiveness of the Act following significant changes to it in 2010. Chapter One outlines what those changes were and the reasons and intentions of Parliament for making them. It details the scope of the review, the qualifications and experience I brought with me, and the approach I took to conducting the review. It notes the principles upon which the review was predicated, including independence, objectivity, an inclusive and rigorous methodology, and openness and transparency. Details are also given regarding the process of consultation, which included
  • preparation and distribution of seven Fact Sheets and a poster that provided information about the review and called for contributions; 
  • the establishment of a consultation space on the YourSAy website where people could gain information, comment and lodge submissions to the review; 
  • the use of social media to engage with the community and draw attention to the review; 
  • letters of invitation sent to invite people to participate in the review; 
  • the collection of written submissions, and the conduct of numerous meetings in South Australia, and beyond, in which I heard the views of people who had accessed assisted reproductive treatment (A.R.T.) and donor conception, donors, donor-conceived people, academics, representatives from government agencies, fertility clinics, medical associations, law associations, consumer organisations, and support groups. The views of the contributors to the review informed this final report and the recommendations I make to the Minister for Health.
Chapter Two: Oversight
The discussion in Chapter Two considers the operation and effectiveness of the Act focusing upon the changes made to the South Australian regulatory approach. It details how the  current Act and regulations changed prior regulatory oversight and advice mechanisms that existed via the South Australian Council on Reproductive Technology (SACRT), and repealed the Code of Ethical Clinical Practice that contained detailed provisions governing A.R.T. The changes introduced in 2010 saw South Australia move to a ‘co-regulatory’ system implementing framework legislation, which stipulates registration conditions for A.R.T. providers, and requires adherence to National Health and Medical Research Council Guidelines (NHMRC Ethical Guidelines) combined with the self-regulatory Reproductive Technology Accreditation Committee (RTAC) accreditation process. Examination of the intentions of Parliament reveal that the changes were intended to reduce what was seen as duplication in terms of regulatory oversight and ethical guidance, regulatory costs and burden, and to improve the regulation of A.R.T. practices in South Australia. Further discussion ensues in Chapter Two regarding how the co-regulatory system could be improved to give effect to the intentions of Parliament and to ensure effective oversight of, and compliance with, the Act.
Chapter Three: Welfare of the Child
Chapter Three focuses upon section 4A of the Act which provides the welfare of any child to be born as a consequence of the provision of A.R.T. must be treated as being of paramount importance, and accepted as a fundamental principle, in respect of the operation of the Act. It was the intention of parliament to maintain and strengthen the provision under the changes made to the Act in 2010, parliament stating that the interests of children born as a result of A.R.T. must be placed above all other parties. In considering the welfare of the child provision in the context of the operation and effectiveness of the Act, the review was particularly concerned with
  • whether there was support for the paramountcy of the child provision, and its being strengthened as part of the 2010 changes; 
  • how the provision was being used, and to what effect; 
  • what sorts of considerations were being made and/or systems put in place to uphold the provision; what guidance was needed, if any, as to the sorts of considerations that should or should not be made; 
  • whether the paramountcy of the welfare of the child principle was being upheld in practice; 
  • whether more needs to be done to ensure the paramountcy of the welfare of the child principle is met, and if so, what.
Recommendations are made that will support the better operationalisation of the paramountcy of the welfare of the child principle, and consistency of practice across clinics in upholding the principle.
Chapter Four: Establishing the Donor Conception Register
Chapter Four begins with a brief history and overview of donor conception, and the changes that have occurred across various jurisdictions that have moved to provide for access to information by donor-conceived people about their donors and siblings. Such history and changes form the backdrop to discussion of the operation and effectiveness of the current Act, which in 2010, provided that the Minister may establish a donor conception register. Chapter Four notes that to date a donor conception register has not been established. The Chapter reflects upon submissions by donors, recipients, and donor-conceived people who wish to exchange information. For more than thirty years many have called for access to identifying information in South Australia. From at least the early 2000s the former SACRT, and the South Australian Social Development Committee, also called for the establishment of the register. Current practices regarding information recording and release by clinics are examined, and their support for the donor conception register noted. The primary recommendation in this regard is that the Minister should act to establish the donor conception register as a matter of priority. Past records and practices are also discussed. The Chapter highlights the concern that some past records are currently held in places that do not fall under the auspices of the Act, and that donor-conceived people that they relate to are not afforded the same protections as others. The call to transfer all records onto the donor conception register is made. The subsequent question of whether to provide access to information by all donor-conceived people, regardless of when they were born is examined; alongside how to balance their interests with those who donated under a previous regime, who may wish to protect their privacy. The release of information to donor-conceived people is recommended, subject to a system that offers intermediary and support services to all parties, and the option for donors to lodge a contact veto/preference statement. The recommended system would achieve a balancing of the interests of donor-conceived people, who seek information, with the interests of past donors, who may wish to determine the level of contact, if any, they would be willing to have.
Chapter Five: Further Matters Regarding Donor Conception and Access to Information
Chapter Five continues examination of matters related to donor conception that were raised via submissions and meetings during the review. In particular, it focuses upon matters related to the operation of the donor conception register and access to information, including
  • where the donor conception register should be located; 
  • the provision of intermediary and support services; 
  • access to information by donor-conceived people, recipients, donors, and siblings; 
  • voluntary registration of information upon the register by known donors and past donors (when records do not exist); 
  • information to be held on the donor conception register; 
  • notification of donor-conceived status via an addendum to the birth certificate; 
  • entry of information about biological heritage on birth registration statements, and second birth certificates; and 
  • cost considerations regarding transferring records to the register, and the ongoing functions of the register and provision of intermediary and support services.
These matters go to the operation and effectiveness of the current Act as it provides for the establishment of a donor conception register, and requires that the paramountcy of the welfare of the child be upheld. They also serve to respect the interests of donors and recipients of A.R.T.
Chapter Six: Access to A.R.T.
Chapter Six focuses on access to A.R.T. in South Australia. It outlines how the current law operates via the setting of ‘conditions’ for registration for clinics providing A.R.T that determine to whom, and under what circumstances, clinics may provide such treatment. This compares to the previous regime by which an extensive Code of Ethical Practice determined access requirements. The discussion examines how the 2010 amendments maintained some of the previous requirements regarding who could access A.R.T and in what circumstances—including requirements of infertility for more invasive treatments, and risk of a child being born with a serious genetic defect. The amendments also introduced a number more instances in which A.R.T could be used, such as risk that a serious disease or serious illness would be transmitted to a child conceived naturally; illness which may in the future result in infertility; and the posthumous use of sperm when the woman’s deceased genuine domestic partner/spouse has left written instructions prior to his death that his sperm could be used by his widow to conceive a child. How the old and new requirements for access are working, and any adjustments that need to be made, are examined. Other issues raised in submissions relevant to access to A.R.T. are also considered. Recommendations in relation to such things as body mass index and obesity, smoking, age related considerations, social egg freezing, social sex selection, and process issues, are made.
Chapter Seven: Record Keeping
Chapter Seven provides information on the pre- 2010 South Australian legislative provisions regarding record keeping and the operation and effectiveness of the Act following the 2010 changes. It notes that issues relevant to record keeping are discussed throughout the report, for example regarding donor conception, and the short and long term health outcomes for children born as a result of A.R.T. and for recipients and donors. Further discussion of record keeping and measures that would improve record keeping and reporting relevant to A.R.T. to enhance the operation and effectiveness of the Act ensues.
Chapter Eight: Conclusion
Chapter Eight concludes the report. It provides brief discussion of other concerns relevant to A.R.T. in South Australia, and looks to the future. It ends by summarising the recommendations I have made to make more effective the operation of the Act, by addressing issues related to the oversight and regulation of A.R.T., the paramountcy of the welfare of the child principle, establishing the donor conception register, access to A.R.T., and record keeping.