61 Danks St West
Port Melbourne
VIC 3207
Phone: 03 9645 6359
Facsimile: 03 9645 6322
Email: kimo@wsm.com.au
The Director General of Health
NSW Health
Dear Sir,
I write to make a submission on behalf of the Fertility Society of Australia regarding the Assisted
Technology Regulation 2008 under the Assisted Reproductive Technology Act 2007.
We are strongly supportive of this Act and it’s aims, to prevent the commercialisation of human
reproduction and to protect the interests of persons involved in providing gametes, undergoing
treatment and particularly those being born as a result of ART.
However, we are very concerned that we have still not been informed about arrangements for
implementation of the Act. We are, in particular, deeply concerned at suggestions that mere
approval of these regulations will be sufficient to trigger enactment. On the contrary, there is
still much work to be done to allow smooth implementation of the legislation. We would like to
work with the Department, as suggested below to achieve this.
We have four principal concerns about the content of the regulations as well as a number of
points to make about specific points in the regulations.
1.
Privacy .
We remain deeply concerned about the arrangements for protection of the privacy of this critical
information about the donors. There is nothing in the regulations to specify how this system is
to work. We were very disappointed by this.
2.
Who is making the decisions?
This legislation will lead to many individual issues arising that will be of critical importance to the
people concerned. Many detailed decisions will require to be made about interpretation and,
particularly, implementation of the Act in relation to individual cases and persons. We cannot
see who will be making these decisions.
NSW is the only state legislature to have introduced legislation of this sort regulating ART
without also establishing a regulatory body with expert advice to administer the Act. Under the
NSW legislation, many decisions are delegated to the Director General of Health. Clearly
he/she will not be in a position to actually make these decisions and they will be delegated
further. We are very concerned about the possibility of an inexpert person making bad
decisions that will cause distress and/or harm to the individuals affected.
We therefore strongly urge the Director General to rapidly establish an expert advisory group,
consisting of consumers, ART providers and others with equivalent expertise to advise the
Director General on the implementation and operation of this Act.
3.
Inspectors and enforcement
The regulations contain no information about how the inspectors are to operate and who will be
advising the Director General on the implementation of this part of the Act.
4.
Women with existing children and/or embryos conceived using donated gametes.
There is a serious difficulty in the specific circumstances of women who have existing children
from donated gametes who were conceived before the Act came into effect and women who
have cryopreserved embryos (resulting from donated gametes) that were already in storage at
the time the Act took effect.
We expressed concern about this in 2007 and the then Minister, Ms Reba Meagher, wrote to
me on 7th December 2007 assuring me that the these women would be allowed to complete
their families through a transitional regulation.
The transitional regulations, as they are drafted in this document, do not, however, allow women
to complete their families in this way.. We would be very grateful if they could be revised to
achieve the aim, as we were promised in 2007.
It is also now clear to us that two years is too short a time for the transitional regulation to
operate. We would urge the Minister to consider a transitional regulation to operate for five
years. The transitional arrangement, would, as above, only apply to families where children had
been conceived before the Act was enacted or to embryos created before the Act is enacted.
We therefore do not believe that prolonging the transitional period for this very small number of
families with a specific circumstance would have a significant effect on the objective of the ART
Act.
Specific issues (referenced to the Act)
Section 12 Counselling to be available
The qualifications for counsellors, prescribed in the regulations are, on the whole, reasonable.
However, we would draw the attention of the Minister to the circumstance at one Sydney clinic
where a GP with many years experience in infertility counselling has long provided high quality
counselling to men and women. Under the proposed regulations, this counsellor would be
unable to provide counselling. We would urge the Minister to consider this specific example in
considering the wording of these regulations.
Section 24 (3) states that we are required to
(3) For the purpose of subsection (1), reasonable steps include:
(a) obtaining from the Registrar of Births, Deaths and Marriages a certificate under
section 49 of the Births, Deaths and Marriages Registration Act 1995 as to whether
the death of the gamete provider has been recorded in the Register kept under that
Act, and
(b) completing such other inquiries as may be prescribed by the regulations for the
purpose of establishing whether the gamete provider is alive.
It is not clear to us, how often we are required to do this in the circumstance where the gametes
were obtained more than 5 years prior to the provision of treatment. We would suggest every
12 months as being a reasonable interval and would be grateful if this could be specified in the
regulations.
Section 27.
It has been drawn to our attention that this definition of family will have serious consequences
for lesbian couples who may wish both female partners to have children within the context of
one family. We would be grateful if a regulation could be worded to avoid causing this degree of
disadvantage to same-sex female couples.
Part 3, Central Donor Register (Sections 33-41)
Our interpretation of this section is as shown in APPENDIX 1. We would be grateful if you could
confirm that our interpretation is correct.
We are very concerned about the processes whereby an adult offspring contacts a donor. This
is a deeply sensitive process and should be managed accordingly. While clearly, the whole
basis of the register is that it will allow donor offspring to obtain information about their genetic
parents, this very sensitive process needs professional support. We would therefore urge the
Department to establish a process where by all applicants for information could be advised to go
through a supportive process to allow applicants access that, while speedy, is also delivered in
an environment that is supportive to both children and donors. Meantime, we would strongly
oppose the inclusion of donor phone numbers in the register. We would be pleased to work
with the Department to help develop a suitable process.
In closing, the Fertility Society would like to urge the Minister to give us the opportunity to work
together with the Department to allow smooth implementation of this Act without patients,
donors and their children being disadvantaged by the new legislation.
Yours faithfully,
A/Prof Peter Illingworth
President
Sydney address:
Medical Director,
IVFAustralia
176 Pacific Highway,
Greenwich
NSW 2065
APPENDIX 1
30. Collection of information
The clinics are required to collect about the donor:
(a) the full name of the donor,
(b) the residential address and telephone number of the donor,
(c) the date and place of birth of the donor,
(d) the ethnicity and physical characteristics of the donor,
(e) any medical history or genetic test results of the donor or the
donor's family that are relevant to the future health of:
(i) a person undergoing ART treatment involving the use of
the donated gamete, or
(ii) any offspring born as a result of that treatment, or
(iii) any descendent of any such offspring,
(f the name of each ART provider who has previously obtained a
donated gamete from the donor and the date on which the gamete
was obtained,
(g) the sex and year of birth of each offspring of the donor.
We also need to record (for sperm donors) the number of women who have given birth to
offspring of the donor.
31
Records to be kept by ART provider
The clinics are required to keep all of the above as well as the following record about the
offspring
(a) the full name, sex and date of birth of each offspring born as a
result of ART treatment, provided by the ART provider
33 Director-General to establish central ART donor register
The clinics will be required to send in to the D-G the following…
About the donor…
(a) the full name of the donor,
(b) the residential address and telephone number of the donor,
(c) the date and place of birth of the donor,
(d) the ethnicity and physical characteristics of the donor,
(e) any medical history or genetic test results of the donor or the
donor's family that are relevant to the future health of:
(i) a person undergoing ART treatment involving the use of
the donated gamete, or
(ii) any offspring born as a result of that treatment, or
(iii) any descendent of any such offspring,
(f the name of each ART provider who has previously obtained a
donated gamete from the donor and the date on which the gamete
was obtained,
(g) the sex and year of birth of each offspring of the donor.
The consent form of the donor
About the birth
(a) the full name, sex and date of birth of each offspring born as a
result of ART treatment, provided by the ART provider, and
(b) the name of the woman who gave birth to the offspring, and
(c) if the offspring was born as a result of ART treatment using a
donated gamete, the full name and date and place of birth of the
donor of the gamete.
The DG will then enter this into the register.
Access to information
Adult offspring as a result of donation will have access to:
(a) the full name of the donor,
(b) the residential address and telephone number of the donor,
(c) the date and place of birth of the donor,
(d) the ethnicity and physical characteristics of the donor,
(e) any medical history or genetic test results of the donor or the
donor's family that are relevant to the future health of:
(i) a person undergoing ART treatment involving the use of
the donated gamete, or
(ii) any offspring born as a result of that treatment, or
(iii) any descendent of any such offspring,
Other adult offspring of the donor (not through donation) will have access to:
Sex and year of birth of each other offspring
Parent of a child born through donation will have access to:
d) the ethnicity and physical characteristics of the donor,
(e) any medical history or genetic test results of the donor or the
donor's family that are relevant to the future health of:
(i) a person undergoing ART treatment involving the use of
the donated gamete, or
(ii) any offspring born as a result of that treatment, or
(iii) any descendent of any such offspring,
Sex and year of birth of each other offspring
The Donor will have access to:
Sex and year of birth of each offspring