Thursday, December 6, 2018

Victorian ART review interim report


The interim report on the Victorian Assisted Reproductive Treatment Review undertaken by Michael Gortonam and his team has released a 146 page interim report.  In its executive summary, the report says:
            “In some cases, it has been possible to make clear recommendations at this early stage, in others the Report presents issues that require further explanation before a recommended response can be proposed.  Where possible, the Interim Report flags likely directions and/or areas where further targeted consultation will be undertaken over coming months to test ideas with the community or gather further intelligence in order to identify a way forward...Many stakeholders spoke positively about their experience of assisted reproductive treatment (ART) in Victoria.  Recipients of ART express their gratitude for the availability of services and the opportunity to pursue treatment in order to try to expand their families.  Victoria compared favourably with the rest of Australia and other parts of the world on a number of key safety indicators.
Nonetheless, the Review has already identified a number of areas where improvements can be made.
Although Victoria has greater regulation of ART than most other Australian jurisdictions, there remain ongoing concerns about the adequacy of oversight of quality and safety, and the impact of increased corporatisation and expansion of the sector.  While the Review notes that corporate provision of healthcare is not unique to this setting and does not equate to an unmanageable conflict of interest, the weight of opinion that patient experiences being adversely affected by some business and clinical practices warrants further consideration.
Furthermore, the Review has heard credible and significant evidence that breaches of the [Assisted Reproductive Treatment] Act and risks to patients’ safety are not always identified and/or appropriately acted upon.  The public consultation has raised concerns about patient experience, and that these concerns are not always being adequately attended to by the industry.  There is strong support from many stakeholders for a stronger role for a regulator to provide independent oversight of the co-regulatory arrangements in this industry…Various provisions within the ART Act are discriminatory against particular groups in the community.  Furthermore, the Review has heard some evidence of a range of social, cultural and practice barriers to treatment, and a lack of inclusive service provision for particular groups in the community.  The experience of LGBTIQ+ (lesbian, gay, bisexual, trans and gender diverse, intersex, queer etc) people accessing ART services has been a particular focus on the consultation and findings of the Review.
A further barrier to treatment is access to donors and surrogates for those who require them…A range of approaches to increasing access to donors and surrogates has been considered, with particular reference to the concerns raised by donor-conceived people.”

The initial recommendation dealt with the attempt to remove unnecessary discriminatory barriers to access, especially for the LGBTIQ+ community, the adequacy of safeguards and improving access and affordability more generally.
The recommendations of the review are:

Recommendation 1

It is recommended that the Assisted Reproductive Treatment Act be amended to include protections for individuals who report, or intend to report, breaches, or possible breaches, of the Act, or non-compliance with the conditions of registration of a provider, to the relevant regulator.  It should be an offence for any person to refuse to employ, or dismiss another person, to refuse to treat another person or to subject another person to any detriment because the other person makes such a report to the relevant regulator.
Comment
This is clearly designed as a whistleblower provision.

Recommendation 2

It is recommended that legislation be amended to facilitate the sharing of information between relevant regulators and other bodies for the purpose of identifying and responding to concerns about safety and quality and assisted reproductive treatment.  This will include sharing of quality and safety information between Victorian Assisted Reproductive Treatment Authority, the Patient Review Panel, the Australian Health Practitioners Registration Authority, the Health Complaints Commissioner, Safer Care Victoria, the Department of Health and Human Services and the Minister for Health.
In particular, the Patient Review Panel should be empowered to report incidences of potential breaches of the Act to relevant regulators for investigation. 

Recommendation 3

It is recommended that section 8 of the Assisted Reproductive Treatment Act [by which only doctors can provide artificial insemination except in a home situation] such that artificial insemination may be carried out by:
(i)                 A doctor; or
(ii)              By a person acting under the direct or indirect supervision and direction of a doctor who is carrying out artificial insemination on behalf of a registered provider.

Recommendation 4

It is recommended the Act be amended to remove any discrimination against married women who wish to access assisted reproductive treatment following separation.  The Act should ensure that where a married couple have separated, the consent of a person who would otherwise meet the definition of a partner is not required to undertake treatment, provided that their gametes are not used without specific consent.
The government should undertake further consultation in the most appropriate way to implement this objective, and any implications for related legislation. 

Recommendation 5

It is recommended that the definition of “donor” in the Assisted Reproductive Treatment Act be amended, as well as other defined terms which include the word “donor”, to make it clear that, regardless of gender, sexuality, gender identity or marital or relationship status, where a person provides gametes for use by their partner in a treatment process, that person is not considered a donor for the purposes of the Act.
Comment
This would be quite helpful.  There was a Court case in Western Australia about this very point earlier this year when a woman tried to use her late husband’s sperm.  Both the IVF clinic and the Western Australian regulator opposed the use of the sperm because they deemed the dead man to be a donor.  The Supreme Court of Western Australia found otherwise.
The view has also been expressed that surrogacy involves donation – even when the party are using their own eggs and sperm (which clearly it is not). 

Recommendation 6

It is recommended that a new provision be included in the Assisted Reproductive Treatment Act to create a presumption that where a person has provided gametes for use by their partner in a treatment procedure, consent is withdrawn in respect to the use of those gametes or any embryos formed from such gametes, following the separation of the couple.
Comment
The report comments:
            “This provision is intended to provide clarity for the clinics regarding the status of gametes and embryos and storage once they are made aware of the separation of a couple.  It is not intended that the clinic will need to make enquiries as to the ongoing relationship status of people receiving treatment.  The provision will address a gap, where currently the law is silent.”

Recommendation 7

It is recommended that section 46 of the Assisted Reproductive Treatment Act, which relates to posthumous use of gametes and embryos, be amended to provide that where written consent was provided by the deceased person, and appropriate counselling has been undertaken, the Patient Review Panel may approve the use of the deceased person’s gametes, or embryos created from a deceased person’s gametes:
·         in a treatment procedure carried out on the deceased person’s partner, or

·         by the deceased person’s partner in commissioning a surrogacy arrangement regardless of the gender of the person or their partner).
Additionally, the requirement for written consent might be reconsidered, and the Patient Review Panel may be permitted to approve posthumous use where it is satisfied that the use is not inconsistent with the deceased person’s express wishes.
Comment
The Review noted that the section of the Act which allows for the posthumous use of gametes or embryos in specific circumstances has been identified as potentially discriminatory.  Stakeholders have indicated in particular the current drafting unreasonably restricts the posthumous use of gametes, in accordance with the deceased partner’s wishes, by women or by people who had been in same-sex relationships.
The Review heard no rationale for the limitation imposed by the section that restricts posthumous use of gametes and surrogacy arrangements to a woman’s male partner. Accordingly it was proposed that the provision be amended and simplified to remove these discriminatory elements.
Further, it would be appropriate to reconsider the need for written consent in cases involving the posthumous use of gametes.  The Patient Review Panel should be authorised to approve posthumous use of a deceased’s person’s gametes, or embryos created from such gametes, where it is satisfied that the use is not inconsistent with the deceased person’s express wishes.

Recommendation 8

Consistent with the objectives of the Victorian Equal Opportunity Act 2010 and similar Commonwealth legislation, and recognising the diversity of our people in relationships, it is recommended that the guiding principles of the Assisted Reproductive Treatment Act be amended to use non-discriminatory language, including in relation to gender, where appropriate and that the anti-discrimination principle be expanded to recognise people who are currently excluded. 

Recommendation 9

It is recommended that the Act be admitted to remove any language that is potentially discriminatory against, or not inclusive of, particular individuals or groups on the basis of their sexual orientation, marital or relationship status, gender identity or sex characteristics.  This would include:
·         Replacing discriminatory terms and using more inclusive language;

·         Amending the Act so that the Patient Review Panel may approve a surrogacy arrangement is satisfied that there is a medical or social need for the surrogacy arrangement [consistent with approaches interstate] to remove the requirement for same-sex couples to demonstrate that they are unlikely to become pregnant.

Recommendation 10

It is recommended that section 29 of the Act be amended to ensure that the limit on the use of donated gametes applies to families rather than women.
Comment
The current restriction on donating gametes to more than ten women discriminates against women in same-sex relationships.  The discrimination can have the effect of preventing women in same-sex relationships having biologically related children by accessing the same donors’ gametes.  By amending the provision to replace the word woman with families, the Assisted Reproductive Treatment Act will remove this barrier and recognise women in same-sex relationships as a family.
Further consideration will be given to the appropriate limit on the number of families able to use gametes from the same donor. 

Recommendation 11

The Victorian Assisted Reproductive Treatment Authority and the Patient Review Panel should work together with the LGBTIQ+ community to develop embedded, regular inclusive practice and cultural competency training for ART industry members and staff.
VARTA should amend the conditions of registration to require clinics to ensure that all staff involved in patient contact be required to undertake training in LGBTIQ+ inclusive practice.
Comment
HOORAY! 

Recommendation 12

It is recommended that the Assisted Reproductive Treatment Act be amended to allow for gamete donors to modify or evoke consent only up until the time the gamete is used, either for insemination or to create an embryo.
Comment
The Review noted the proposal aims to bring Victoria into line with interstate practice where withdrawal of consent by a donor is only permitted until the gametes have been used to create an embryo.  The amendment will bring greater certainty for intended parents who wish to make independent decisions about the use of embryos created with donor gametes.

Recommendation 13

It is recommended that the Act be amended to remove requirements for donors to consent to the extension of storage or disposal of embryos formed from donated gametes.

Recommendation 14

It is recommended that the Assisted Reproductive Treatment Regulations be amended to allow for the payment or reimbursement of reasonable costs that are incurred by a surrogate where the cost would not have been incurred but for the surrogacy arrangement.   It is intended that this should better reflect the actual costs incurred by surrogates as a result of taking on that role.  Costs that may be covered should include, but not be limited to:
·         Medical costs for the birth mother (including costs incurred prior to the conception, during pregnancy and after delivery) or a child born as a result of a surrogacy arrangement where these are not payable by Medicare or private health insurance;

·         A premium payable for health, disability or life insurance that would not otherwise have been obtained;

·         Counselling expenses;

·         Reasonable legal costs for the birth mother and their partner (if any);

·         Lost earnings because of leave taken:

(i)                 for a period of not more than 2 months during which a birth has happened or is expected to happen;

(ii)              for any other period during which the surrogate was unable to work on medical grounds as a result of the surrogacy.

·         Other out-of-pocket expenses including travel, accommodation or childcare.
The nature of costs agreed by the parties to a surrogacy arrangement should be disclosed to the Patient Review Panel as part of the application for approval of the surrogacy arrangement.
Comment
HOORAY!  It will be a delight if Victoria falls into line with other States such as New South Wales and Queensland, so there is some consistency with interstate surrogacy arrangements, which are common.  The Review quoted submission by Karen Gough and me:
            “Many hours are spent trying to discern the meaning of ‘reasonable expenses’…It would be helpful in the Victorian legislation set out with some particularity what is reasonable and gave examples.  It would be even more helpful if the regulations set figures as to what is reasonable.  These figures should be generous to reflect reality.”
The Review noted feedback from the Victorian Assisted Reproductive Treatment Authority highlighted a specific case where intended parents had agreed to reimburse the surrogate for medical, legal and counselling costs but failed to do so following the birth of the child.  In the words of the Review:
            “This example highlights how physically, emotionally and financially vulnerable surrogate mothers may be in the context of a surrogacy arrangement.”

Recommendation 15

It is recommended that section 44 of the Assisted Reproductive Treatment Act be amended to make it an offence for all parties to enter into, or offer to enter into, a commercial surrogacy arrangement.  A surrogate must not receive any material benefit or advantage as a result of the surrogacy arrangement and the intending parents must not provide or offer to provide material benefit or advantage in exchange for the surrogacy arrangement.
Comment
The Review heard feedback that while that section prohibited a surrogate from receiving material benefit or advantage as the result of a surrogacy arrangement, there was no corresponding offence for intended parents to offer such inducements.

Recommendation 16

It is recommended that references to “commissioning parents” in the Act be replaced with the terms “intended parents”.
The Review said:
            “Feedback to the Review highlighted that the current reference to “commissioning parents” may be offensive to people who hope to become parents through surrogacy, and that the terms “intended parents” more accurately reflects these aspirations.”
The Review then quoted the submission by my associate Karen Gough and me:
            “Time and again we have heard from those who want to be parents that the reference to commissioning parents sounds as though they are buying a child, much in the same way that they might be buying a fridge, a car or a house.  Many of them find this term offensive.  We urge a legislative language change.”

Recommendation 17

It is recommended that the Status of Children Act be amended to remove the now redundant reference in section 23(3).  A new provision should allow for parties to a surrogacy arrangement to receive counselling from a counsellor providing services on behalf of a registered ART provider or an independent counsellor who meets specified qualification criteria and has relevant experiences and skills. 
Comment by the Review
Section 23(3) of the Status of Children Act provides that relevant parties to a surrogacy arrangement must receive counselling from a counsellor within the meaning of section 61(3) of the Assisted Reproductive Treatment Act 2008.  This is an incorrect cross-reference of section 61(3) has been repealed.
The Review was persuaded that consistent the approach in Queensland and New South Wales and the NHMRC Ethical Guidelines, more counselling support should be provided for intended parents and surrogates during the pregnancy and following the birth of a child.  It is envisaged that further consultations in the coming months will explore ways to achieve better outcomes for all participants to a surrogacy arrangement.  In addition to offering counselling during the pregnancy on an optional basis, the Review will consider the need for counselling to be undertaken prior to the finalisation of parentage orders in Victoria in a surrogacy context.
The Review quoted the submission by Karen Gough and me:
            “Surprisingly, there is no requirement in Victoria for there to be a post birth assessment that the proposed arrangement is in the best interests of the child.  The assumption is made that because approval has been obtained from the Patient Review Panel, the surrogacy arrangement must be an appropriate one.  In our view this is misguided.  Having an independent assessment as seen in New South Wales and Queensland is a vital tool in informing the judge that the proposed arrangement is in the best interests of the child.”
The Review heard that stakeholders with expertise in surrogacy matters considered Queensland and New South Wales to offer the best models for surrogacy counselling.  The Review then referenced the approaches in New South Wales and Queensland as to the requirements for counselling.
The Review said:
            “The Review finds the arguments for clarifying the qualifications of those offering surrogacy counselling compelling, and will consult on the most appropriate set of qualifications and skills to incorporate into the Act in the coming months.  The Review will also consider whether there is a need to make independent counselling available to individuals going through a surrogacy process.  Further consideration will be given as to whether independent counselling should be optional mandatory.  The Review will also reflect on whether different counselling requirements might be appropriate for different stages of counselling in the surrogacy process.”

TRADITIONAL SURROGACY

Traditional surrogacy, while it can occur at home, cannot occur currently in Victoria through an IVF clinic.  Rainbow Families Victoria said:
            “We are very concerned by the low take-up of altruistic surrogacy since 2010 and understand that there are some rainbow families engaging in ‘traditional surrogacy’ to circumvent the Act.  Given that Rainbow Families Victoria places children’s rights and best interests at the centre of their advocacy, we recommend that the altruistic surrogacy provisions in the Act to be amended to ensure that the practice of traditional surrogacy does not flourish ‘under the radar’ in any way that continues to negatively impact upon women’s health nor the legal certainty for the child about the identity of their parents.”
The Review considered:
            “That it would be appropriate to bring traditional surrogacy within a clear and supportive regulatory framework which would allow individuals to access clinic services, and will give consideration to the appropriate way forward on this issue.”
Comment
HOORAY!
PARENTING ORDERS IN RESPECT OF OVERSEAS SURROGACY ARRANGEMENTS
As the Review said:
“While there is nothing in Victorian legislation to prevent individuals or couples from entering into surrogacy arrangements overseas, the effect of the Status of Children Act is that only commissioning parents who have engaged in domestic surrogacy may apply for a substitute parentage order in Victoria.  The Full Court of the Family Court confirmed in the case of Bernieres & Another and Dhopal & Another [2017] FamCA 769 that there was no legal basis for making parentage orders in respect of a child born to a Victorian couple through a surrogacy arrangement in India.  This was because the Victorian legislation does not provide for the circumstances of birth in this case.  While the case considered the situation of a couple from Victoria, the problem is not unique to Victoria and raises similar problems in other jurisdictions.”

The Review then cited a submission by Karen Gough and me that:

            “Family law experts indicate that the current state of the law in this area represents a fundamental failure to protect children born as a result of overseas surrogacy arrangements, and argued that Victoria should legislate to enable the making of parentage orders under the Status of Children Act when parents have undertaken surrogacy overseas.”

These concerns were echoed by Surrogacy Australia and Rainbow Families Victoria.

The Review said it:
            “…will consider how the current gap in the law with respect to available parenting orders in overseas surrogacy arrangements can best be resolved.  The Review anticipates an appropriate solution will need to be pursued at the national level, in consultation with other Australian jurisdictions.”

The Review questioned whether there should be further requirements of the Act to deal with elective egg freezing, fertility preservation treatments.

The Review thought that there should be more information provided to patients and counselling.

NEXT STAGE OF THE REVIEW

The Review will be:
·         working towards more transparent oversight of quality and safety in assisted reproductive treatment;

·         considering the need for more effective co-regulatory arrangements;

·         exploring opportunities for the public provision of assisted reproductive treatment;

·         considering what might be needed to establish a Victorian sperm and egg bank;

·         providing better support services to connect patients, donors and surrogates;

·         improving information available to people seeking treatments;

·         enhancing patients’ care and counselling.

1 comment:

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