15 August 2011
ByAppeared in BioNews 620
The new Victorian legislation has moved from a licensing system for ARTs to a system of registration. This enables individual medical practitioners and fertility clinics to apply to the Victorian Assisted Reproductive Treatment Authority (VARTA) for registration as an ART provider. It also works alongside national accreditation requirements set out by the Fertility Society of Australia (FSA). To some extent this alleviates the burden of complying with a multi-layered regulatory approach due to the range of regulatory requirements at the State and national level. Although the legislation has been in force for some time, there has been a significant shift in policy more recently concerning the regulation of PGD (preimplantation genetic diagnosis) which is worthy of note.
Under the previous statutory scheme in Victoria, ART providers were required to adhere to policies concerning PGD which had been issued by the former State regulator, the Infertility Treatment Authority (ITA). Victoria's approach to PGD regulation was one of the most prescriptive of all the Australian states and territories. In the three tier system of regulation, a condition of the clinic's licence was that they were required to gain prior permission for PGD for novel purposes (for instance the detection and selection of embryos on the basis of tissue-type. Cases falling within this 'novel' category are similar to those outlined under the Human Fertilisation and Embryology Authority (HFEA)'s Code of Practice in the UK for case-by-case approval. Thus, PGD in such cases must be approved in advance by the regulator.
However, as Victoria's new statutory regulatory body, VARTA has confirmed it will no longer play a role in regulating PGD techniques. Therefore the decision to undertake PGD will be left to individual clinics. There are some exceptions to this approach, such as cases where PGD is intended for sex-selection, or where PGD is being carried out for a reason other than a potential risk of transmitting a genetic condition if the participants were to conceive naturally. In these instances, an application must to be made to the State's Patient Review Panel for approval, which must consider and prioritise the welfare of any child who may be born following the process.
The implication of this change in policy is that the regulation of PGD will no longer be determined by the Victorian regulatory body, but will instead be subject to national regulatory provisions impacting on ART providers in Australia (including national guidelines issued by the FSA and the National Health and Medical Research Council). The national guidelines in place concerning ARTs are effectively minimal standards of ethical practice and do not impose any requirement to obtain approval prior to utilising PGD techniques (with the exception of tissue-typing techniques, which must be considered by an ethics committee). This means that, for the most part, case-by-case approval for PGD is no longer the position in Victoria.
This change in PGD policy seems to accord with the general spirit of the new statutory framework, which seeks to adopt a 'light touch' in terms of the regulatory approach. This also leaves the regulatory position in Victoria concerning PGD similar to the position in most other Australian jurisdictions, such as New South Wales.