Thank you to Kayla Hathaway for her assistance in preparing this update.
Introduction
The Queensland Minister for Health, Mental Health and Ambulance Services and Minister for Women has publicly committed to regulating the Assisted Reproductive Technology (ART) industry and relevant ART services this year. ART helps those with fertility issues, genetic risks and who identify as LGBTIQ+ to have children.
The Queensland Department of Health sought feedback from stakeholders to help inform the regulation of ART services, including preliminary requirements an individual must meet prior to accessing ART treatment, tissue use and storage, privacy and information storage and a proposed licencing system for ART providers in Queensland. The consultation has closed and stakeholder feedback is being considered. Here we consider the proposals regarding the regulation of ART providers specifically and what a regulatory regime might mean.
Current regulatory framework
Presently, in lieu of Federal legislation regulating ART services in Australia (or State legislation in Queensland), ART services are guided by national professional accreditation frameworks and guidelines including those published by the National Health and Medical Research Council (NHMRC) Guidelines 1 and the Reproductive Technology Accreditation Committee (RTAC) of the Fertility Society of Australia Code of Practice2.
Many Queensland-based ART providers are self-regulated in accordance with the national framework. However, this approach lacks cohesion among providers and the necessary mechanisms for oversight and enforcement in cases where a provider may fail to meet the obligations prescribed in the guidelines.
Proposed approach
Currently, ART providers are required to be accredited by the RTAC and comply with its Code of Practice and NHMRC Guidelines. However, there is currently no mechanism for Queensland's Department of Health to ensure or enforce compliance with the national framework by all ART providers.
Many states and territories have enacted or are in the process of developing legislation to oversee ART services beyond the national guidelines which enforces a licensing requirement or registration scheme and significant penalties can apply for breaching this requirement including imprisonment and substantial fines.
It is expected that implementation of legislation in Queensland will allow for a state-based framework to oversee ART providers which aligns with the existing national framework but with scope to introduce additional regulations as necessary. The goal of introducing such legislation is to protect the welfare and interests of those seeking to access or receive ART services by prioritising their health and well-being, upholding the rights of donor-conceived individuals, ensuring the preservation of human rights for all parties involved in ART and prohibiting exploitation of ART services for commercial gain.
ART providers should be aware that a key proposal in Queensland, if carried into the legislation, will be a licensing scheme, requiring providers to be licensed with the Director-General of Queensland Health. Under this scheme, ART providers must be accredited with RTAC to be eligible to obtain a license. Additionally, ART providers may be subject to eligibility criteria which includes a fit and proper test by the Director-General and if there have been any prior offences under ART legislation in other jurisdictions. The associated fee in obtaining this licence can vary starting from $3,000, with an annual renewal fee of $2,270.
Where providers fail to comply with any licence conditions (including maintaining RTAC accreditation amongst others), it is proposed that the future legislation will allow for the issuing of improvement notices and/or suspension or cancellation of a licence where it is deemed appropriate.
What does this mean for ART providers in Queensland?
As the consultation period has now closed, stakeholder responses are expected to inform the development of legislation in Queensland that is aligned with the obligations of ART providers nationally. However, as with any consultation period, the proposals outlined above may be subject to change.
Should legislation be implemented in Queensland, it will be important for ART providers to be aware of the potential conditions including the eligibility criteria to obtain a licence to provide ART services, the associated costs, the potential conditions to licences, consequences of contraventions to these conditions, registration and notification requirements and inspector powers.
The regulation of ART services in Queensland has the potential to bring about significant protections for persons seeking ART services by mandating the licensing of ART providers and ensuring adherence to the obligations arising under the national framework. Most states and territories in Australia have already established, or like Queensland, are in the process of developing legislation to regulate ART services beyond the national standards. From the outside looking in, Queenslanders and ART providers alike will undoubtedly benefit from clear regulation and we look forward to providing a further update once the results of the consultation are made available.
Footnotes
1 Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research 2017
2 Code of Practice for Assisted Reproductive Technology Units 2021
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.