Sonia Allan - Consultant

1. Report on the review of the
Assisted Reproductive
Treatment Act 1988 (SA)
(The review was conducted from Dec 2015 to Jan 2017)
Sonia Allan
BA(Psych)(Hons) LLB(Hons)
LLM (Global Health)(Dist) MPH(Merit) PhD
Associate Professor (Health Law), Deakin University
Consultant www.sallanconsulting.com

2. Introduction to the Review
2009: South Australian Government introduced significant changes to the Assisted
Reproductive Treatment Act 1988 (SA).
2010: The changes came into effect on 1 September 2010. They included a
requirement that the operation and effectiveness of the Act be reviewed after the
fifth anniversary of the changes to the Act.
2015: The Minister appointed me to lead the review, which was conducted between
December 2015 and January 2017.
2016: Public consultation via fact sheets, web based consultation space (YourSAy),
social media, written submissions, face-to-face meetings), research, analysis,
report writing
2017: The report on the review was tabled in Parliament by the Minister for Health in
April 2017. The government response is expected in August/September 2017.
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3. Introduction to the Review
Terms of Reference
The review evaluated the operation and effectiveness of the changes made to the Act
including:
1. matters pertaining to the regulation and oversight of ART
a. the replacement of the previous licensing scheme with a registration scheme for clinics providing assisted
reproductive treatment (A.R.T.);
b. the dissolution of the SA Council on Reproductive Technology and its Code of Ethical Conduct;
2. 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.;
3. allowing for the establishment of a donor conception register;
4. 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
5. provisions regarding record keeping and confidentiality.
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4. REGULATION AND OVERSIGHT
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5. Regulation and Oversight
Pre-2010 Post- 2010
Relevant South
Australian Law
 The Reproductive Technology (Clinical Practices) Act 1988
 The Reproductive Technology (Code of Ethical Clinical Practice)
Regulations 1995.
 The Act was renamed The Assisted Reproductive Treatment Act
1988 (SA)
 The Code was repealed, and replaced with The Reproductive
Treatment Regulations 1995
Licensing/
Registration
 Licensing system (served to limit new providers in the area. New
licenses only granted if unmet social need not met by existing
licensees – seen as anti-competitive).
 Registration Scheme – Clinics register with Minister pursuant to
meeting RTAC accreditation, and conditions stipulated in Act and
regulations.
Oversight
 Reproductive Technology Accreditation Committee (RTAC) (via self-
regulatory accreditation scheme)
 South Australian Reproductive Technology Council (SACRT)
 Minister
 RTAC (via self-regulatory accreditation scheme)
 SACRT dissolved
 Minister
Ethical Guidance
 The Reproductive Technology (Code of Ethical Clinical Practice)
Regulations 1995
 NHMRC Ethical Guidelines on the Use of Assisted Reproductive
Technology in Clinical Practice and Research 2004 (revised 2007)
 South Australian Reproductive Technology Council (SACRT)
 SACRT dissolved
 SA Code of Ethical Clinical Practice Repealed
 NHMRC Ethical Guidelines
 Ethics Health Advisory Council (mentioned by Parliament, but not in
legislation/regulations)
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6. Regulation and Oversight
• The changes introduced in 2010 saw South
Australia move to a ‘co-regulatory’ system
implementing framework legislation and
requirements to adhere to self-regulatory
accreditation and ethical guidelines.
• Changes were intended to
• reduce duplication in terms of regulatory
oversight and ethical guidance,
• reduce regulatory costs and burden,
and
• improve the regulation of A.R.T.
practices in South Australia.
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7. Regulation and Oversight
In evaluating the system that had been implemented it was found that
 The co-regulatory system adopted in 2010 to govern A.R.T. in South Australia complements other
laws that aim to ensure best practice and standards are met not only in the practice of A.R.T., but in
all areas of medicine.
 It removed anti-competitive provisions, and the system of registration was working effectively.
But,
 monitoring of compliance, and enforcement of the Act is not being adequately operationalised by the
Minister;
 lack of reporting to, and auditing by the Minister regarding the self-regulatory aspects of the regime
also compromises the accountability and openness required for an effective co-regulatory regime;
 Sole reliance upon the NHMRC Ethical Guidelines raised concern it being seen to be problematic to
rely on a set of ethical guidelines to regulate A.R.T. in a state that has a legislative framework without
having a uniform point of reference for guidance and interpretation of such guidelines.
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8. Regulation and Oversight
Creating a system for effective
co-regulation
…It is important to ensure that
the Act is effectively
operationalised while not creating
unnecessary regulatory burden
or functions.
…too much top down
governance should be avoided.
….On the other hand, it is not
acceptable to do nothing, as a
co-regulatory system requires
active participation in the
regulatory system by both
government and clinics.
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9. Regulation and Oversight
Other recommendations:
 Health practitioners providing A.R.T. outside of clinics should be subject to same
requirements as those working in clinics.
 The Minister should ensure provision in the Act for review of its operation and
effectiveness five years after the date of the report from the last review being tabled in
Parliament.
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10. WELFARE OF THE CHILD
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11. Welfare of the Child
Pre-2010 Post- 2010
Welfare of the
Child
 Welfare of the child prescribed as a guiding
principle
 Welfare of the child provision retained and
strengthened: Requiring that the welfare of the
child born as a result of the use of ART be
considered as paramount and of fundamental
importance in the application of the Act and in the
provision of assisted reproductive treatment.
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12. Welfare of the Child
Focus of the review:
 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 (including asking 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/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.
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13. Welfare of the Child
Particular issues raised included:
 Screening for heritable diseases
 Sex selection for social purposes
 Screening of donors for heritable conditions, updating health
information, disclosure
 Screening applicants for risk of harm
 Screening donors for prior criminal history
 Research – promotion, regulatory responsiveness, support
 Establishment of a donor conception register (considered in
chapters 4 & 5 of the report)
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Recommendations
and findings were
made, including how
the recommended
co-regulatory system
would benefit
ongoing review and
responsiveness to
these and future
issues

14. Welfare of the Child
 Screening for heritable diseases, serious illness
 Consistent with paramountcy of welfare of the child principle subject to limitations on the
severity of disease/illness being screened
 Sex selection for social purposes
 Not consistent with paramountcy welfare of the child principle (reflects parental preference,
raises issues concerning gender identity, social issues raised, not supported by majority of
public)
 Screening of donors for heritable conditions, updating health information,
disclosure
 Screening for heritable conditions consistent with paramountcy of welfare of the child principle
 Updating health information and disclosure linked to record keeping and registers – Minister
must establish avenues for this to occur to uphold paramountcy of the welfare of the child
principle.
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15. Welfare of the Child
 Screening applicants for risk of harm
 Inconsistent practices found across clinics - Uniform approach needed
 Submissions call for screening in relation to risk of harm to children
 Victorian system of criminal record checks and ‘patient review panel’ found to be unsatisfactory (bureaucratic, burdensome, costly,
not necessarily protective of children)
` Recommendation
 uniform system of assessment (including criteria to be discussed, process and record keeping requirements),
 Ability to work with external agencies when there is concern (eg. ability to check an individual’s criminal record/child
protection records/sex offenders register), and
 linking applicants in with necessary services (eg. family violence, drug and alcohol, counselling, treatment, etc.) if
treatment is refused.
 Screening donors for prior criminal history
 Recommended further consideration by A.R.T. Advisory Council and Minister
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16. Welfare of the Child
Research – promotion, regulatory responsiveness, support
 The Minister should re-establish the promotion of research, and reporting on research
and the outcomes of A.R.T. practices, as a required function of the recommended A.R.T.
Advisory Council under the Assisted Reproductive Treatment Act 1988 (SA) (1988).
 The Minister should issue regulations, conditions of registration, or directives from time-
to-time, informed by research on the short and long term outcomes for people born as a
result of A.R.T., that may set the bounds of A.R.T. practice necessary to uphold the
principle of the paramountcy of the welfare of the child.
 The Minister should consider and act upon the government’s ability (if any) to fund
and/or support independent research that may contribute to ensuring the health, welfare
and safety of children who are born as a result of A.R.T. and donor conception.
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17. ESTABLISHMENT OF A DONOR
REGISTER
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18. Establishment of a donor register (access to information)
Pre-2010 Post- 2010
Information
 Detailed requirement for information recording about
recipients and donors
 Provisions regarding access to non-identifying records
by recipients (identifying with consent)
 Access to non-identifying information about recipients,
and number and sex of children (if any), by donor
 Recipients required to be counselled about the
importance of disclosing to donor-conceived children
about their status, and children’s entitlement to non-
identifying information about their donors (identifying
with consent)
 Provision of information to third-parties (e.g. via a
register) impeded by confidentiality provisions.
 Disclosing identifying information dependent upon
consent
 Provision that Minister may establish a donor conception
register
 If register established provision that:
o Enables transfer of data to the register (removing
confidentiality impediment)
o Requires information to be recorded about
donors/recipients/child (without register, record
keeping requirements default to NHMRC Ethical
Guidelines)
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19. Establishment of a Donor Register –
Why the call for access to information?
 Desire to know about heritage
 Medical History
 Identify formation
 Human rights
 Equality
 Desire to know about genetic siblings
 Donors want to share information
 Parents want to be able to tell their children
 Fear risk of consanguineous relationships
 Openness, honesty
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Legal, medical,
psycho-social, and
ethical arguments
for providing access to
information

20. Sonia Allan 2017 20
Sperm
Donor
(Given
Discrete ID
1b)
Recipient 1a&b
(Egg and
Sperm)
Offspring 1ab1
Offspring 1ab2
Recipient 2
Offspring 2b1
Recipient 3 Offspring 3b1
Offspring 3b2Recipient 4
Offspring 4b1Recipient 5
Offspring 5b1
Offspring 5b2
Recipient 6
Offspring 6b1
Offspring 6b2
Offspring 6b3
Recipient 7
Offspring 7b1
Offspring 7b2
Recipient 8
Offspring 8b1
Offspring 8b2
Offspring 8b3
Recipient 9
Offspring 9b
Recipient 10
Offspring 10b1
Offspring 10b2
Half Siblings from
Donor 1c
19 Half-
Siblings from
donor 1b
Sperm
Donor 1c Donor’s
family –
4 children
Offspring
10c1
Up to eight
other
recipient
families
(Possible
8/16/24/32
children)
Offspring
10c2
Half-Siblings
(10b1, 10b2) &
(10c1 & 10c2)
Egg
Donor
1a
Donor’s
family - 2
children
Offspring 10c1 & 10c2 in the example,
have between 14-38 half-siblings
Figure 3 - Example Donor Conception
Relationships: 10 Family Limit
Donor 1a’s children and Offspring
1ab1 and 1ab2 are half-siblings

21. Establishment of a Donor Conception Register
 The review revealed the call for information by recipients, donor-conceived people,
and some donors, has existed for more than thirty years and from at least the year
2000, the government’s own representatives and advisors (including SACRT and the
Social Development Committee) have been calling for the donor conception register to
be established.
 I found the delay in establishing the register to be unacceptable given the impact
it has had, and continues to have on those born as a result of A.R.T., as well as their
families, and donors and their families. It is contrary to the paramountcy of the welfare
of the child.
 My recommendation was thus that the Minister establish the donor conception
register as a matter of priority.
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22. Establishment of a Donor Conception Register
– Past Donations
Issues were also identified surrounding past records and practices in South Australia:
 Some records are currently held in places that do not fall under the auspices of the Act,
and donor-conceived people that they relate to are not afforded the same protections as
others.
 There was a devolving of responsibility by one of the clinics who had created such records
(and the children to whom they relate) due to changes in company ownership and place of
business existed.
 The experiences of recipients and donor-conceived people in trying to access such records
had caused them, and continues to cause, great distress and angst.
 Recipients, donor-conceived people, and donors have been met by different staff who told
them different things at different times about whether records had been destroyed, and if
told they did exist, whether access to information could be had.
 There was confusion and lack of support about past records and practices, and the current
situation to be unacceptable
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23. Establishment of a donor register
PROTECTING AND PRESERVING THE RECORDS
 My recommendations were first to ensure that all past records are
transferred to the donor conception register to ensure that
remaining records are preserved.
 This would serve as a significant restorative measure to address injustices caused by the
past “closed” culture that perpetuated donor anonymity, it being expressed to me that at
least then donor-conceived people could trust what they are being told.
 I also recommend as a matter of priority that the Minister make it an
offence to destroy past records relating to donor conception.
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24. Establishment of a donor conception register
ACCESS TO INFORMATION ABOUT PAST DONORS
 The inquiry also examined whether to provide access to information by all donor-
conceived people including those born under the past systems of secrecy and
anonymity, and if so, how to balance their interests with those who donated under a
previous regime who may wish to protect their privacy.
 While there was unanimous support for the register to be established by everyone that participated in
the review, there were differences in opinion about whether consent should be required prior to the
release of past records.
 However, on balance, donors, recipients and donor-conceived people supported release of records to
donor-conceived people whether or not consent had been given, subject to a contact veto system.
 Recommendation:
 the government should implement a system in which information could be accessed
by donor-conceived people subject to a contact veto being able to be lodged by past
donors.
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25. EXPERTISE
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Clinics – collect information about
clinic based recipients, donors, and
donor-conceived people, and pass it
on to BDM.
Parent(s) may access non-identifying
information about donor and siblings
when child is under 18.
Parent(s) who have used a ‘known’
donor input information on birth
registration form, and have option of
placing donor on second birth-
certificate issued by BDM for
children under 18.
Births, Deaths and Marriages
Operate donor conception register
in which data is recorded and can
be linked to respective donor,
recipient, and donor-conceived
persons’ birth records.
BDM issues second birth-certificate
with biological parentage at the
request of recipient family (when
child is under 18 and a ‘known’
donor has been used); or at the
request of donor-conceived person
over 18 or of sufficient maturity.
BDM issues addendum to birth
certificate when donor-conceived
person turns 18 and applies for
certificate notifying them of further
information held on the register.
Voluntary registration on the donor
conception register (e.g. by ‘known’
and past donors) possible, subject
to meeting BDM requirements.
Donor-conceived people, siblings,
and recipient/donors with children
under 18, may register consent to
release of identifying information to
a donor and/or sibling and/or
recipient family. (Non-identifying
information available upon request)
Intermediary and Support
Services Provider
Works as ‘trusted agency’
with BDM to provide
intermediary services related
to access to information
about past donors, family
linking and the contact
veto/preference system
(required); as well as
intermediary services for
children under 18, and
siblings (if required).
‘Support services’ (e.g.
counselling) provided when
•no information exists;
•contact veto/preference
states no contact;
•donor, recipients, or donor-
conceived person needing
support. (Optional services).
Intermediary and support
services may hold/pass on
further information (e.g.
photos, updates, or letters) to
and from the respective
parties if decided appropriate.
Donor-conceived person over 18 or of
sufficient maturity may access identifying
information about donor via BDM (subject
to intermediary services/contact veto
system for past donations). May also
access non-identifying information about
siblings (identifying subject to consent).
Donor-conceived person may request
information about biological parent(s) be
placed on second-birth certificate.
‘Known’ donors or past donors may
voluntarily register their information
on the donor conception register
subject to BDM requirements.
Donors, recipients, and donor-
conceived people may request non-
identifying information about
offspring and siblings. (Age, number,
sex, number of families).
Consent to release identifying
information may be registered by
donor-conceived people; siblings;
recipients and donors with children
under 18.
INFORMATION SUPPORT
System operational now, but also
ready for a future in which
* all donor information has been
consented to be released;
* requirement for support services
declines (donor-conception families
are accepted as “normal families” who
are curious about, and meet relatives,
like everyone else)
•System will continue to be able to
provide a place to consent to release of
information and make links between
siblings that may otherwise not be
known.
•System may also provide a way of
tracking that the ten family limit is not
exceeded by linking data about donor
to his/her birth record.
Figure 4: Recommendations for Donor Conception Register and Access to Information in South Australia

26. ACCESS TO ASSISTED
REPRODUCTION
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27. ACCESS TO ASSISTED REPRODUCTION
Pre-2010 Post- 2010
Access to ART
 Marital requirement (declared void in 1996 in Pearce v South
Australian Health Commission (1996) 66 SASR 486)
 Infertility
 Risk of passing on genetic disease
 Counselling requirements in Code (focus on children, outcomes and
need for information)
 ‘Screening’ - No treatment if prior offences or removal of children;
illness that would impact ability to care for children
 Stored embryos to be destroyed if husband or wife dies, dissolve
their marriage, or revoke consent
 Welfare of the child principle
 Appeal and review process for access to treatment decisions
 Removed marital requirement
 Infertility
 Risk of passing on genetic disease
 Risk of passing on serious illness
 Risk of future infertility of recipients
 Counselling provisions removed (some covered in NHMRC Ethical
Guidelines).
 No ‘screening’ criteria included
 Donated gametes must be destroyed after 15 years
 Welfare of the child principle
 Removed appeal and review processes
 Posthumous use of sperm (if conditions are met)
 A.R.T. not to be provided to woman of greater than or equal to the
average age of menopause
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28. ACCESS TO ASSISTED REPRODUCTION
FINDINGS
 Refer to welfare of the child considerations, findings and
recommendations regarding:
 Sex selection for social purposes
 Screening for heritable disease, serious illness
 Screening for risk of harm to child(ren)
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29. ACCESS TO ASSISTED REPRODUCTION
FINDINGS
Posthumous use of gametes:
 while broadening access provisions, needed further clarification regarding when such gametes may be used, and
whether they may be transported out of the state without written consent.
Infertility
 The review received numerous submissions concerning what is perceived to be discriminatory and possibly risky exclusion
of women who do not meet the infertility requirement under the Act.
 Extensive inquiry into discrimination across all laws of South Australia has recently been conducted by the South Australian
Law Reform Institute (SALRI) on matters related to discrimination, and its recommendations included reference to the
Assisted Reproductive Treatment Act.
 The review deferred to that inquiry in relation to its findings on removing the infertility requirement to allow people who
are unable to become pregnant in their circumstances (eg. single women, same sex couples) to access A.R.T., and
recommends that the Minister act in this regard.
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30. ACCESS TO ASSISTED REPRODUCTION
Social Egg Freezing:
 Removing the infertility requirement for access to A.R.T. has the effect of allowing social egg freezing to occur in South
Australia.
FINDING:
Although social egg freezing may highlight certain social and structural issues in the society in
which they live (which ideally society should address), such issues do not indicate it is
necessary to prohibit an adult woman from deciding for herself whether she wishes to pursue
egg freezing. Consumers of such services must be fully informed of the risks involved in
engaging in such procedures. Laws exist to prohibit misleading and deceptive conduct or
advertising; require informed consent; and establish professional standards of care and
practice for all health practitioners.
NB. The report notes that there is again a role for the recommended A.R.T. Advisory Council to keep an eye on the evidence,
and to respond with advice to the Minister, if and when further required.
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31. ACCESS TO ASSISTED REPRODUCTION
FINDINGS
Other issues raised in relation to:
 body mass index and obesity,
 smoking,
 age related considerations, and
 what the first line of inquiry should be prior to IVF (i.e. non-invasive/low
cost vs invasive/higher or high cost),
as well as recognition that the technology is an area of relatively rapid
changes/advances/experimentation, highlight the need for the government to
put into place mechanisms that support, and provide for, the opportunity for
more effective regulatory oversight, consultation on ethical and policy issues,
and responsive regulatory responses.
It was recommended that such matters would benefit from further
consideration by the recommended A.R.T. Advisory Council.
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These issues
again highlight the
need for an
effective co-
regulatory system
and how it would
enable informed
and responsive
regulation of A.R.T.

32. RECORD KEEPING AND REPORTING
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33. Record keeping and reporting
Pre-2010 Post- 2010
Record
Keeping
 Requirements regarding record keeping
 Documents and records to be kept for 50 years
 Limited protections for patients’ and donors' records
when clinics were closed or a licence cancelled.
 Section 16 of the Act allows for the regulations to set
procedures to be followed to ensure that records are
safely and appropriately stored, transferred and/or
destroyed when clinics or other providers of ART cease
to practice. (None currently set).
 Conditions of registration require provision be made for
transfer or destruction of records should registrant cease
to provide A.R.T.
Reporting
 Annual reporting to SACRT required
 Annual report by SACRT to Minister
 Parliament expressed intention to require clinics to
provide copies of their annual national data reports to
the Minister for Health and the Department, the
requirements of which were to be detailed in the
regulations. (Not currently operationalised).
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34. Record-Keeping
• The review revealed gaps in past and present record keeping practices as
highlighted throughout the report on a number of important matters related to
A.R.T. and donor conception practices in South Australia.
• There is also an absence of regulations providing guidance concerning record
keeping.
RECOMMENDATIONS
• A system of auditing and required reporting concerning data and records required
to be kept by A.R.T. clinics and health professionals should be established by the
Minister. This should include reporting of data and records supplied to ANZARD
and/or other bodies.
• The Minister and his Department should reflect upon the auditing/reporting of
records and data relevant to the safety and quality of A.R.T. treatment; clinical
practice of A.R.T.; and outcomes to inform regulatory responses and policy
development concerning the practice of A.R.T. in South Australia.
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These issues
again highlight the
need for an
effective co-
regulatory system
and how it would
enable informed
and responsive
regulation of A.R.T.

35. Record keeping and reporting
RECOMMENDATIONS
(Included with other recommendations regarding donor conception, but noted here)
 The Minister should pass regulations that require clinics to record information at the
time of
 1) donation (on the donor’s record),
 2) treatment, including whether a pregnancy has occurred and expected date of delivery (on the
donor’s and recipient’s records), and
 3) birth (on the donor’s, recipients, and donor-conceived person’s record). Such information should be
regularly reported to the Minister, as well as relevant information being entered into the donor
conception register.
 The Minister should require, and monitor, adherence to the RTAC technical bulletin 8
concerning counselling, agreement, and reporting on matters related to the use of
donor sperm, eggs, or embryos.
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36. ACKNOWLEDGEMENTS
 As the independent reviewer of the Assisted Reproductive Treatment Act 1988 (SA) (the Act), I gratefully acknowledge the
many people who shared with me their stories, wisdom, knowledge, experience, and views. Their contributions to the review
enabled me to better understand the key issues and complexities affecting people born as a result of assisted reproductive
treatment, consumers and industry in South Australia. Via submissions, meetings, and follow up discussions, they were able
to inform me of how current practices do or do not meet community expectations, and what more they felt could be done to
give effect to the provisions and intentions of the Act.
 I thank the Honourable Jack Snelling, Minister for Health for putting his faith in me to lead the review. It was an honour to
have been appointed to undertake it.
 I acknowledge the assistance and support of Ms. Zoe Gill, Senior Policy Officer, and Ms. Samantha Parker, Policy Officer, in
the Department for Health and Ageing who provided executive assistance to the review. I commend them for their attention
to detail and efforts as the review proceeded. I and am grateful for the contributions each of them made.
 I also pay thanks to people within the Department for Health and Ageing including (but not limited to) Skye Jacobi, Executive
Director Policy & Governance; Prue Reid, Director Legal Governance and Insurance Services; Rachel Newrick, Assistant
Director, Policy and Intergovernment Relations; Lee Wightman, Principal Consultant, Policy and Intergovernment Relations;
Alex Trinca, Policy Officer, Policy and Intergovernment Relations; and Simone McDonnell, Ministerial Adviser to the Minister
for Health. Thank you also to Helen Paues, Registrar, Registration Branch of Consumer Business Services, who provided
me with information regarding the register of Births, Deaths and Marriages.
 To all of the MPs and staffers who attended the Parliamentary Briefings, and/or have followed the progress of the review, I
thank you also for your interest and care in relation to the matters that were being considered, and place faith and hope in
you that you will support the recommendations in the report.
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37. SONIA ALLAN
Email:
• Sonia.Allan@sallanconsulting.com or/
• S.allan@research.deakin.edu.au
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