Thursday, 17 October 2024
Bills
Health Legislation Amendment (Regulatory Reform) Bill 2024
Bills
Health Legislation Amendment (Regulatory Reform) Bill 2024
Second reading
Debate resumed.
Ingrid STITT (Western Metropolitan – Minister for Mental Health, Minister for Ageing, Minister for Multicultural Affairs) (14:02): I would like to thank all members for their contributions on this bill today, including those with lived and living experience and those who have shared their insights and their own personal stories. The Allan Labor government is strengthening health regulation to better protect Victorians, including those who are accessing or were born through assisted reproductive treatment. This bill gives effect to reforms that were announced last December to strengthen and reform health regulation in Victoria, providing greater consistency to regulation across the health system through the newly established health regulator.
I would like to acknowledge the amendment put forward by Ms Crozier and thank her for her engagement with the Minister for Health’s office. The amendment is to include a three-year legislative review, and the amendment will be supported by the government as it aligns with the purposes and aims of this reform work. We know that the health and assisted reproductive treatment sector is complex and continues to rapidly evolve with developments in science and technology as well as social attitudes and community expectations. Review of the implementation and operation of these legislative reforms will be ongoing and iterative to ensure the best outcomes for Victorians. Certainly a formal, three-year legislative review will support this work.
With respect to the amendment that was foreshadowed by Dr Mansfield, the government will not be supporting this.
The bill was developed followed public consultation earlier this year, and we are very grateful to have received input from many stakeholders, including people with lived experience. It also draws on previous consultation work and work undertaken, including the Gorton review recommendations. We will also continue to engage closely with stakeholders and lived experience advocates throughout implementation, and this includes through the establishment of a donor conception advisory body made up of experts and people with lived experience.
I also want to acknowledge the concerns raised by Mr Bourman, who wants to ensure that children are protected from serious sex offenders who may seek to game the system to get access to children. Of course nobody wants this to happen, and the government undertakes to explore how this could be best addressed.
In summary, the reforms in the bill are necessary to ensure that health regulation in Victoria is modern and evolves in line with contemporary best practice regulation and with changes in risks, technology, knowledge and practice and community expectations. This means a safer, stronger health system for all Victorians. I commend the bill to the house.
Council divided on amendment:
Ayes (7): Katherine Copsey, David Ettershank, Sarah Mansfield, Rachel Payne, Aiv Puglielli, Georgie Purcell, Samantha Ratnam
Noes (30): Ryan Batchelor, Melina Bath, John Berger, Lizzie Blandthorn, Jeff Bourman, Gaelle Broad, Georgie Crozier, David Davis, Moira Deeming, Enver Erdogan, Jacinta Ermacora, Michael Galea, Renee Heath, Ann-Marie Hermans, Shaun Leane, David Limbrick, Wendy Lovell, Bev McArthur, Joe McCracken, Nick McGowan, Tom McIntosh, Evan Mulholland, Harriet Shing, Ingrid Stitt, Jaclyn Symes, Lee Tarlamis, Gayle Tierney, Rikkie-Lee Tyrrell, Sheena Watt, Richard Welch
Amendment negatived.
Motion agreed to.
Read second time.
Committed.
Committee
Clause 1 (14:12)
Georgie CROZIER: Minister, in my contribution earlier I referred to the Fertility Society of Australia and New Zealand’s interim draft report and recommendations. I know I have had some discussions, as I indicated, and I do not see why the government cannot be working on some of those recommendations. The one I am particularly interested in, apart from anything which could be undertaken now, is recommendation 2, which is:
The development process be facilitated through the Council of Australian Health Ministers supported by a Steering Committee composed of representatives from patients, donor conceived individuals, fertility specialists, industry experts, FSANZ professional groups (nursing, psycho-social, scientific and clinical) and legal practitioners with fertility expertise.
I am just wondering if there have been any moves towards working towards that aim?
Ingrid STITT: The national review of governance and standards conducted by the Fertility Society of Australia and New Zealand is, as you have referred to, an important piece of work, and assisted reproductive treatment (ART) in Victoria is regulated under the Assisted Reproductive Treatment Act 2008 and associated regulations. At present the changes proposed in the Health Legislation Amendment (Regulatory Reform) Bill 2024 are the key focus of our reforms, and of course the Gorton review recommendations also form part of the Victorian context for potential future reform of regulation. But we are aware of the FSANZ – so many acronyms in this policy area – proposals for a national legislative framework and national register.
The reforms in the bill certainly do not preclude any agreement to a national plan or related reforms to establish national legislation and/or a national register. That would obviously be something that would have to be agreed to by all jurisdictions, and at this time there is no proposed agreement between the Australian government in relation to national plans for ART regulation and related functions. Certainly we would participate in good faith if there were to be any discussions at that level, and I think we would add that having the relevant Victorian functions located within the Department of Health as proposed by these reforms before the house today would make any future move to a national system a little simpler.
Rachel PAYNE: Minister, this bill proposes dissolving the Victorian Assisted Reproductive Treatment Authority and in doing so will transfer all existing staff to the Department of Health. VARTA’s counselling staff are in employment limbo, given the commitment to offer counselling services through a yet-to-be-established, private provider, so I ask: what measures will be in place to ensure continuity of care for those accessing VARTA counselling services under those changes, and can you confirm all existing counselling staff will be employed by the new, private provider?
Ingrid STITT: I can confirm that the bill does provide that VARTA staff employed immediately before the commencement would be employed by the Secretary of the Department of Health; that would obviously be on no less favourable terms and conditions of employment. VARTA and the Department of Health will continue to support staff in navigating that employment transition, and the regulatory and registry functions will remain appropriately resourced throughout the transition period, including the issues that you raised in relation to access to counselling. Obviously there are some changes in the bill before the house in relation to changing the mandatory nature of some counselling, but I am happy if you want to take me there in your line of questioning.
Sarah MANSFIELD: Just further to the questions on counselling, the department advised that the counselling function will be outsourced. Currently VARTA provides a highly specialised counselling service that is independent from ART providers and has counsellors with a very high level of qualification given the specific and complex nature of the counselling that is often accessed by people coming to VARTA. Who will this be outsourced to, and what assurances can you provide about the qualifications and expertise of the counsellors that will be providing that service?
Ingrid STITT: The government has committed to delivering funding for an appropriate organisation, and of course it is incredibly important that that organisation can provide suitably qualified and experienced counsellors to deliver both quality counselling and culturally safe counselling for those involved in accessing the registers and those who may wish to access counselling. At this point in time there is not an appointed organisation, but we are very mindful of the need to make sure that there is that expertise available, and that would be the way in which the Department of Health would commission that service.
Sarah MANSFIELD: What assurances can you provide that that external counselling service will be independent of ART providers?
Ingrid STITT: That is obviously an important principle, and it would be no different to the way in which counselling is delivered now, but obviously not through the same entity structure. It would be through an arrangement with an appropriate third party. We would expect the Secretary of the Department of Health would ensure that the arrangements were such that there was no conflict of interest.
Georgie CROZIER: Can I just follow on in relation to some questions that I received from a constituent around some of these issues. I was going to go to them later on, but I might as well bring them up now. One of the questions was: how will the health department protect minors seeking to find out about their donors when counselling services are being abolished? Can you respond to that?
Ingrid STITT: The advice that I have got is that a minor seeking to access information from the registers will be required to undergo counselling to determine the maturity of that child, and this requirement is being retained because the counselling is related to ensuring the maturity of the child to make an application or to understand the consequences of a disclosure of information from the registers.
Georgie CROZIER: This is still on the counselling question, but it relates to clause 45, if I can jump to that. I do not want to go back and forth for you, but it is still around the counselling question. It is my understanding that that is in regard to the removal of mandatory counselling for accessing the register and explanatory material. Could you explain what that explanatory material consists of? Is that both verbal and written advice? What does that consist of?
Ingrid STITT: The donor conception registrar will be required to provide explanatory material to anyone who applies for information from the registers or who can lodge a contact preference under the act, and this material will be developed with specialist input from experts and that will deal with matters currently covered during mandatory counselling, such as the rights and duties of the parties, the potential implications of disclosure and where to access support.
Georgie CROZIER: I am jumping around slightly, but it goes on to what you have just said in terms of the explanatory material. A new subsection under clause 34, in my understanding, says the donor conception registrar must also make ‘all reasonable efforts’ to provide any prescribed explanatory material to the person. What are ‘all reasonable efforts’? What does that consist of? Does that mean that that material will be provided by the department, or is that outsourced? What does that actually mean, ‘all reasonable efforts’?
Ingrid STITT: Just one moment. Sorry, Ms Crozier. Thank you for being patient with that, Ms Crozier. ‘All reasonable efforts’ is in relation to proactive requests, but if I could just point out to you that in clause 62, ‘Disclosure of information’, the requirement is that all information must be provided. If I can take you to clause 62(2), new subsection 72(2) states:
Before disclosing information about a person under subsection (1), the Donor Conception Registrar must …
Therefore it is a requirement, whereas if it is a proactive situation, then all reasonable efforts must be made. I hope that clarifies that question for you.
Georgie CROZIER: I think it does, and it goes to I think also one of the questions I had from my constituent, which was: what suitable crisis and support services will be provided to donor-conceived people who are now finding out as adults that they were donor conceived? They are finding that it can be incredibly traumatic, as my constituent writes. Therefore, that disclosure of information would pertain to that question also. Am I correct in assuming that?
Ingrid STITT: The donor conception registrar will be required to provide explanatory material to anyone who applies for information from the registers or who can lodge a contact preference under the act, and this material will be developed with specialist input from experts and deal with matters currently covered during mandatory counselling, such as the rights and duties of the parties, the potential implications of disclosure and where to access support, noting, as you have said, that it can often be very traumatic to find out this kind of information.
Georgie CROZIER: Thanks for that response, Minister. I have just got one more before I move on to specific clauses. I do not have many questions, but if I could ask: how will the government continue to fund research and education into donor conception to make sure that children know about their origins and that crucial longitudinal studies around IVF-conceived children are continued?
Ingrid STITT: Ms Crozier, the government acknowledges and understands that the public education resources that have been developed by VARTA are very highly valued by the community. The department is committed to ensuring continued access for the public to VARTA’s existing suite of resources, including information on prevention of infertility, navigating fertility treatment and donor conception and of course research, and these will be published on the department’s website and maintained as appropriate.
Georgie CROZIER: Could I just ask, on that issue around the publication of annual reports: is that on the website? How will that be done? How will that be managed, that information? Is it an annual report? Will that information be published, including what you have just said?
Ingrid STITT: Sorry, Ms Crozier, just bear with me. Right, so the advice that I have got, Ms Crozier, is that stakeholders, as part of the engagement around these reforms, have provided feedback to the department about the value of data about assisted reproductive treatment in Victoria that is currently collected by VARTA. Of course there is also regular reporting that occurs under the current entity.
Georgie CROZIER: They have an annual report, I understand.
Ingrid STITT: Yes, and the department intends to continue to report annually on the performance of the regulatory and registry functions, including reported adverse events. Appropriate arrangements for other data currently in VARTA’s annual report, such as data about success rates and other data about instances of IVF treatments, are under further consideration, but there is certainly an intention and a commitment to report annually.
Rachel PAYNE: Minister, why was the decision made to dissolve VARTA rather than to just shift the regulatory role to the Department of Health?
Ingrid STITT: Perhaps I can answer it by giving a bit of information about the reason why the government has pursued the reforms and why we believe that they are necessary. There is obviously a lot in this bill about streamlining regulation, including that of assisted reproductive treatment providers and other matters that the bill deals with. I guess the government is mindful that reforms are also intended to reflect changes since VARTA was established. I am certainly no expert – there are people in this room that are more knowledgeable about these matters than I – but I understand from our department officials that there is significant change that has occurred since the inception of VARTA. There have been a lot of clinical and social advances in relation to fertility treatment, and assisted reproductive treatment is an increasingly common means of family formation. The government obviously does acknowledge the specialised aspects of assisted reproductive treatment as a health service requiring specific legal protections as well as the unique challenges for those with lived experience. We think that the changes are really about improving compliance and enforcement as well as of course streamlining all of our health regulation through the Department of Health. Having all of those regulatory functions sit with the health regulator and also having a separate division within the department, which is the registrar, we think is an efficient and modern and appropriate way to deal with an area of health that is as important as all the other areas of health that the health regulator is responsible for.
Rachel PAYNE: Why are the functions relating to education, community consultation and research proposals not being legislated? Will these services cease to be offered?
Ingrid STITT: No, not at all. As I confirmed to Ms Crozier earlier, we have every intention that education, consultation and research functions, being really important, will continue, and unlike VARTA, those functions can be undertaken by the department in an ongoing way without requiring their specific inclusion as a function in the act. But we understand and we are very aware that the public education resources that have been developed by VARTA are very highly valued by the community. The department is committed to ensuring that we continue access for the public to not only that existing suite of resources, but obviously we would also continue to maintain the provision of information and education through the department’s website and other ways in which people want to access that information.
Rachel PAYNE: What is the expected cost saving from dissolving VARTA?
Ingrid STITT: I would have to seek some advice on that. This is not an exercise that has been driven by cost at all. This is about streamlining our regulatory functions within the Department of Health, and it is certainly not cost that is driving this. But I am happy to take a bit more instruction from the box.
Ms Payne, there is no cost saving associated with these reforms.
Sarah MANSFIELD: The Gorton review made a recommendation to remove mandatory counselling for all ART. The government has failed to implement that particular recommendation, including in this particular round of amendments to the Assisted Reproductive Treatment Act 2008. When is this likely to occur?
Ingrid STITT: Can I just get clarification of what you are specifically asking for a timeline around?
Sarah MANSFIELD: The removal of the requirement for mandatory counselling for anyone accessing ART of any kind. Currently it is mandatory to undergo counselling if you access any form of ART. The Gorton review recommended removing that requirement. That was the main recommendation with respect to mandatory counselling that the Gorton review made. The changes around mandatory counselling that have been made in this act were not actually recommended by Gorton. I am just wondering when those recommendations that were made by Gorton will be implemented.
Ingrid STITT: The advice I have got is that the specifics that you raise are outside the scope of this bill. We want to take a staged approach to the implementation and the consideration of the Gorton review recommendations. The question around the counselling will be something that we will consult further with stakeholders on, but it is not being implemented as part of the bill before the house today.
Sarah MANSFIELD: I thank the minister for that response. In a similar vein I have another question that is related to the ART act but perhaps will be considered once again outside the scope of this bill. I am happy for you to take the question on notice, but currently under section 41(a) of the ART act, same-sex couples have to prove that they are unlikely to become pregnant to access surrogacy. Earlier this year Australia’s peak fertility organisations all agreed to expand their definition of infertility to better represent same-sex couples, and they have come up with a new definition that acknowledges the inability to achieve a successful pregnancy based on a patient’s sexual history and the need for medical intervention to achieve a successful pregnancy. This is a much more inclusive definition, and it also means that same-sex couples do not have to prove that they are unlikely to become pregnant if they want to conceive via surrogacy. These peak fertility groups have called on governments to align legislation with this new definition, so I am just wanting to get a sense of if and when the government plans to remove that requirement that same-sex couples that are trying to access surrogacy have to prove that they are unable to become pregnant.
Ingrid STITT: It is the same answer really. It is not part of what is before us today, but I am advised that there will be further consideration and consultation around that question.
Rachel PAYNE: Minister, just to bring you back to the question of costs, you have advised that there are no cost savings associated with this bill. Are you able to advise what costs then are associated with this bill, or do you claim that there is no change in costs despite the cuts to counselling and other services, as well as the use of an external provider for counselling, as detailed in the bill?
Ingrid STITT: There are no cost savings associated with the bill; therefore I can say that that is not anything to do with the motivation for these reforms. Of course we will be setting up the functions under the health regulator and setting up the registrar and we will be bringing staff over who want to come over from the existing entity, and of course we will be providing counselling through an appropriate third-party arrangement. Given that all of that work is before us, I think it would be difficult to give you a specific answer on the costs associated with that. Those things will be reported in the normal way through the budget process, but I think we have been quite clear that the reforms do not represent a cost saving.
Rachel PAYNE: I am starting to connect the dots. The Gorton review suggested short-term modest funding of VARTA could assist them to fulfil their role. Was this ever considered or acted upon?
Ingrid STITT: I have already outlined for you the reasons why the government has gone down the path that it has. Obviously all of those matters were considered carefully, but for the reasons I have already outlined, the government is committed to having the work of VARTA sit within the department with the health regulator.
Rachel PAYNE: In relation to the Gorton review, when will the government respond to and implement the recommendations of the Gorton review, if at all?
Ingrid STITT: I can provide you with the following information. The government will be, as I indicated earlier to Dr Mansfield, undertaking a staged response to the Gorton review. We have already implemented several key recommendations relating to public fertility care services, including the establishment of a public egg-and-sperm bank. Other reforms have been implemented to promote access and remove barriers to treatment – for example, enabling individuals such as nurses to undertake artificial insemination under the supervision and direction of a doctor within a registered ART provider. That is recommendation 3 of the Gorton review. We have amended language in the Assisted Reproductive Treatment Act 2008 guiding principles to be more inclusive. That is recommendation 8 of the Gorton review. And we have clarified the meaning of ‘donor’ in the act to make it clear that a person who provides gametes for use by their partner is a partner, not a donor, and that is recommendation 5. As part of the public consultation the department did invite feedback on potential future reforms to the ART act and many of the proposals that we received including in relation to the remaining Gorton review recommendations. The department will consider that in light of potential future legislative changes following the consultation and the implementation of the work that is the subject of the reforms that are before the house today.
The DEPUTY PRESIDENT: Just before I take the next question, I would like to acknowledge that we have a former member of the Assembly in the chamber with us, Mr Barry Stegall, the former member for Swan Hill. Welcome.
Rachel PAYNE: Will the government commit to consulting stakeholders, including the government’s LGBTIQA+ taskforce, on removing the mandatory counselling requirements for assisted reproductive treatment?
Ingrid STITT: Yes.
Sarah MANSFIELD: Has there been any work undertaken by the government to enable donor-conceived people to access information about and connect with siblings directly without going through their donor? This was something that again came through strongly in the Gorton review. Although it was not specifically looking at this issue, they got a lot of feedback about this issue in the review process. This bill does make some minor amendments around the donor register and accessing it as well as disclosure of information. Many donor-conceived people would like to be able to connect with siblings without having to first go through the donor, so I was just wondering what work the government is doing in this space.
Ingrid STITT: So you are talking about informal connections between donors – is that what you are talking about – or informal donations?
Sarah MANSFIELD: This is people who are donor conceived connecting with other people who are donor conceived from the same donor, so they are siblings.
Ingrid STITT: The advice that I have is that that can occur now via the voluntary register, and we do not intend to change that arrangement. That is open to people if they choose to do it that way.
The DEPUTY PRESIDENT: Just before we take the next question, we would like to welcome a visiting member of Parliament, Dr Byreddy Shabari, who is a member of the Indian Parliament, representing the Nandyal constituency in the state of Andhra Pradesh. Welcome.
Rachel PAYNE: This will be my last question, Minister, so I will make it a good one. The Gorton review also recommended expanding counsellors by amending section 43 of the ART act to state that counselling in respect of surrogacy arrangements must be provided by an appropriately qualified counsellor – either a counsellor providing services on behalf of an ART provider or an independent counsellor who meets the definition of ‘appropriately qualified counsellor’. Because this recommendation has not been reflected in this bill, does that mean that the government have effectively ruled out enabling people undergoing ART to access their own independent counsellors and instead retained the monopoly of counselling services provided by ART providers?
Ingrid STITT: I certainly would not want it to be characterised as a monopoly. We would hope that providing suitably qualified and experienced counsellors in this area would be something that would be accessed quite regularly, and I think in one of my earlier answers I indicated that the commissioning of that service would ensure that the counsellors were suitably qualified and had that specific expertise in this field.
Sarah MANSFIELD: This will be my last question. What assurances can you provide that any outsourced counselling services or information or education materials will be freely accessible for people – that is, that there will not be any out-of-pocket costs associated with accessing those counselling services for people once it is outsourced?
Ingrid STITT: I know this has been something that has been raised by a number of stakeholders, and the government has committed to delivering funding so that an appropriate organisation with those suitably qualified counsellors and that expertise can deliver what is going to be a very important service going forward.
Clause agreed to; clauses 2 to 4 agreed to.
Clause 5 (14:59)
Georgie CROZIER: Under clause 5, substituted section 36(3) says:
(g) the person has taken all reasonable steps to ensure that any future use of the donor gametes or embryo produced from donor gametes in Victoria will comply with section 29; and
(h) the person has satisfied any prescribed matter.
This is really going to setting out the requirements that are around that transfer of gametes or moving gametes and embryos in and out of Victoria. My question is: how does the secretary determine if all reasonable steps as outlined in the legislation have taken place, and what types of inquiries and actions will that entail?
Ingrid STITT: There are record-keeping requirements on the clinic, and the regulator would have powers and oversight to make sure that the clinic has taken all reasonable steps. Clause 29 ensures that the clinic would be held accountable for that.
Clause agreed to; clauses 6 to 63 agreed to.
Clause 64 (15:02)
Georgie CROZIER: Minister, clause 64 relates to donor-linking services that will no longer be provided according to the legislation. I am just wondering: what kinds of donor-linking services will continue to be provided given that they are going to no longer provided or they will not happen? It is somewhat vague, and I suppose the question is: how will the department provide appropriate support for people navigating the complex path of making connections with donors if they do not have that provision?
Ingrid STITT: Donor linking, as you know, refers to a process currently undertaken by VARTA of facilitating the exchange of information or correspondence between people affected by donor conception or assisting them to arrange contact – so different from matching genetically connected individuals, which is a process whereby identifying information on the registers can be disclosed. The donor-linking provisions, as you say, Ms Crozier, are proposed to be removed from the act, recognising that individuals may wish to manage these matters in a range of different ways where they feel comfortable to do so. The donor conception registrar and skilled staff will continue to be able to support the voluntary exchange of information where appropriate, and the requirements for matching individuals and disclosing information on the registers are not changing under the bill.
Georgie CROZIER: If I may, you are really just saying that if the support is required or asked for, then there will be services there to provide that ability to link up, as has previously been done through VARTA. Is that correct?
Ingrid STITT: Correct.
Clause agreed to; clauses 65 to 78 agreed to.
New clause (15:05)
Georgie CROZIER: I move:
1. Insert the following New Clause to follow clause 78 –
‘78A New section 123A inserted
After section 123 of the Assisted Reproductive Treatment Act 2008 insert –
“123A Review of operation of this Act as amended by the Health Legislation Amendment (Regulatory Reform) Act 2024
(1) The Minister must cause a review of the operation of this Act, as amended by Part 2 of the Health Legislation Amendment (Regulatory Reform) Act 2024, to be commenced after the third anniversary of the day on which Part 2 of the Health Legislation Amendment (Regulatory Reform) Act 2024 comes into operation.
(2) The Minister must cause a copy of a report of the review to be laid before each House of the Parliament no later than the fourth anniversary of the day on which Part 2 of the Health Legislation Amendment (Regulatory Reform) Act 2024 comes into operation.”.’.
As I outlined in my second-reading speech and through the debate, the Liberals and Nationals will be moving this amendment so that we do have a review or the government undertakes a review in three years time, and I am pleased that the government has indicated that they are supporting that move, so I therefore move my amendment to that effect.
Ingrid STITT: Further to the comments that I made in the second-reading debate, the government will be supporting Ms Crozier’s amendment. We know that this is a very complex area of health policy, and we support the three-year legislative review. It aligns very much with the purposes and aims of this reform work and is something that the government is happy to support.
New clause agreed to; clauses 79 to 120 agreed to.
Reported to house with amendment.
That the report be now adopted.
Motion agreed to.
Report adopted.
Third reading
That the bill be now read a third time and do pass.
Council divided on motion:
Ayes (30): Ryan Batchelor, Melina Bath, John Berger, Lizzie Blandthorn, Gaelle Broad, Georgie Crozier, David Davis, Moira Deeming, Enver Erdogan, Jacinta Ermacora, Michael Galea, Renee Heath, Ann-Marie Hermans, Shaun Leane, David Limbrick, Wendy Lovell, Bev McArthur, Joe McCracken, Nick McGowan, Tom McIntosh, Evan Mulholland, Harriet Shing, Adem Somyurek, Ingrid Stitt, Jaclyn Symes, Lee Tarlamis, Gayle Tierney, Rikkie-Lee Tyrrell, Sheena Watt, Richard Welch
Noes (7): Katherine Copsey, David Ettershank, Sarah Mansfield, Rachel Payne, Aiv Puglielli, Georgie Purcell, Samantha Ratnam
Motion agreed to.
Read third time.
The PRESIDENT: Pursuant to standing order 14.28, the bill will be returned to the Assembly with a message informing them that the Council have agreed to the bill with amendment.