Each year a number of babies are born in NSW as a result of ART treatment using donated gametes (sperm and ova). Prior to the commencement of the ART Act on 1 January 2010, many gametes were donated anonymously. This practice created the situation where individuals born as a result of ART treatment using donated gametes are unable to identify a biological parent. These individuals lack information about their genetic heritage and background which can create medical and social dilemmas for both individuals and their parents and can be distressing.
The ART Act and Regulation were developed to address this situation and a range of other matters relating to ART.
What are the main features of the ART Act and Regulation?
The ART Act requires ART providers to be registered in order to carry out ART treatment in NSW. It also establishes a central donor register (Central Register) that holds information relating to all children born as a result of ART treatment using donated gametes, and each donor. The Central Register is maintained by the NSW Ministry of Health.
Information held on the Central Register can be accessed by people conceived using donated gametes once they turn 18 years of age. The ART Act allows parents to access certain non-identifying information about the donor of their child, and donors to access non-identifying information about their offspring.
In order to ensure that the Central Register holds information about donors and donor conceived individuals, the ART Act and Regulation require ART providers to collect and store information about donors and women undergoing ART treatment and provide this information to the NSW Ministry of Health for inclusion on the Central Register following the birth of every donor conceived child.
In addition, the ART Act and ART Regulation:
- set infection control standards that are to be observed by ART providers,
- require ART providers to ensure that counselling services are available at the place where the ART treatment is carried out,
- place certain restrictions on the use of gametes (such as only using gametes in a manner consistent with the gamete provider’s consent),
- place time limits on the use of donated gametes (no more than 15 years after the gamete was obtained or the embryo was created unless the Secretary's written approval is obtained),
- prevent ART providers from providing ART treatment using a gamete obtained more than five years before the ART treatment unless the ART providers take reasonable steps to determine whether the gamete provider is alive
- prohibit commercial surrogacy,
- prohibit the use of ART treatment using donated gametes if the treatment is likely to result in offspring of the donor being born, whether or not as a result of ART treatment, to more than five women (whether in NSW or elsewhere),
- strengthen record keeping by making the destruction of falsification of ART records an offence
- require that ART providers must retain records for 50 years and pre 2010 records for 75 years.
- provide for the appointment of inspectors who can enter and inspect premises where ART treatment is being carried out.
Registration as an ART provider in NSW
Under the ART Act providers must be registered in order to provide ART services in NSW. Applications for registration must be made on the approved form and accompanied by the fee which is set by the ART Regulation. The current fee for registration is $2,666.00 and the annual renewal fee is $1,888.00.
Applications for registration must be on the approved form and include the name of the applicant, the address of each premises at which the ART services are provided, the name of each of the medical practitioners who provide the ART services, and the name of the counsellor who provides counselling in relation to the ART services provided.
Applications must also include a statement as to whether the applicant has been convicted of contravening any ART legislation, a statement as to whether or not the applicant has been refused federal accreditation or has had federal accreditation suspended, cancelled or revoked, and, where the applicant is a corporation, the registered number and the address of the registered office of the corporation and the principal place of business.
Registration as an ART provider takes effect on the date the Secretary gives the applicant notice of the decision to grant registration.
Once registered ART providers must give notice if they cease to provide ART services, if there is a change in premises at which the ART services are provided or the business address, if there is a change in the medical practitioners who undertake or supervise the ART services provided, or if there is a change in the person providing counselling services. In addition ART providers must give notice of any conviction of the ART provider for contravening any ART legislation; a refusal to grant federal accreditation to the ART provider; suspension, cancellation or revocation of the federal accreditation of the ART provider; and, where the ART provider is a corporation, any change of address of the registered office and principal place of business of the corporation.
Registered ART providers must pay the annual registration fee (currently $1,888.00) before the anniversary of the registered ART provider's registration. The Secretary can cancel an ART provider's registration for failure to pay any fee required by the ART Act and Regulation.
Failure to comply with the requirements of the ART Act and Regulation will result in prosecution and financial penalties for the ART provider.
Central Register, NSW Ministry of Health
The NSW Health Central Register was established to support information for individuals conceived as a result of ART treatment by registered ART providers using donated gametes, donors of sperm, eggs and embryos, parents and siblings of children who are donor conceived, and those born through surrogacy arrangements.
Information on the Central Register can be accessed by people conceived using donated gametes once they turn 18 years of age. The ART Act also allows parents to access certain non-identifying information about their child's donor and donors to access non-identifying information about their offspring.
In order to ensure that the Central Register holds information about all donors and donor conceived individuals, the ART Act and Regulation require ART providers to collect and store information about donors and women undergoing ART treatment and to provide this information to the NSW Ministry of Health for inclusion on the Central Register following the birth of every donor conceived child.
Since the commencement of the ART Act on 1 January 2010 ART providers must provide the following information to the NSW Ministry of Health for the Central Register regarding any live birth resulting from ART treatment using donated sperm, eggs or embryos where conception occurred after 1 January 2010. The information must be provided within two months of the birth:
- full name, sex and date of birth
- name of the woman who gave birth to the child
- full name, date and place of birth of the donor of the gamete
ART providers must also provide the following identifying information about the donor who donated the sperm, eggs or embryo:
- full name, residential address, date and place of birth
- the ethnicity and physical characteristics
- any medical history or genetic test results of the donor or the donor’s family that are relevant to the future health of:
- a person undergoing ART treatment involving the use of the donated sperm, eggs or embryo, or
- any offspring born as result of that treatment, or
- any descendent of any such offspring
- sex and year of birth of other offspring arising from the donation
- name of each ART provider who has previously obtained donated sperm, eggs or embryo from the donor and the date on which the sperm, eggs or embryo were obtained.
People who were donor conceived after 1 January 2010 will not be able to access the Mandatory Information that has been collected by ART Providers until 2028, i.e. when they turn 18 years of age. However, parents of those who were donor conceived can apply for non-identifying information contained on the Central Register about the donor. Identifying information about a donor can only be provided to parents under special circumstances in the event of a medical emergency or life threatening situation.
In the last 30 years, attitudes to donor conception have changed. Prior to 1 January 2010, few regulations existed regarding consent of the donor or accurate record keeping. In addition, many donors provided eggs, sperm and embryos under the condition of anonymity.
The NSW Ministry of Health has developed internal procedures for the exchange of voluntary information designed to assist those donors and donor offspring seeking information about each other. However because the NSW Ministry of Health does not hold health records, ART providers are required to assist in the facilitation of the exchange of voluntary information.
People who were donor conceived before 1 January 2010 and people who fall within the transitional provisions, can register information about themselves on the Central Register. Donors who donated sperm, eggs or embryos before 1 January 2010 can also register their details on the Central Register. Where both the donor and donor conceived have given their express consent to do so, information about each other can be exchanged. ART providers are required, where possible, to assist with this exchange of information.
As a result of changes to the ART Act that commenced in May 2016 individuals conceived prior to the commencement of the ART Act as a result of ART treatment provided by an ART provider using a donated gamete are entitled to de-identified information, known as "accessible information", about their donor.
Individuals born as a result of ART treatment using donated gametes to whom the transitional provisions of the ART Act apply, that is although they were born after the commencement of the ART Act information about their birth is not on the Central Register, may also make an application for accessible information about their donor.
"Accessible information" about the donor of a gamete is non-identifying information about:
- the ethnicity and physical characteristics of the donor;
- the relevant medical history of the donor; and
- the sex and year of birth of each offspring of the donor.
Applications for this information can be made to either NSW Health or directly to the ART provider. Applications can be made by people over the age of 18 years who were conceived as a result of ART treatment using a donated gamete (ova or sperm) or embryo, or the parent where the person is a child.
When an ART provider receives an application for accessible information the ART provider must provide the information in writing to the applicant within 28 days
. If the ART provider does not have the information or has reason to believe that another ART provider has the information a statement to that effect must be provided to the applicant. The ART provider must also give a copy of the information given to the applicant to the Secretary, NSW Health along with any information the ART provider has about the identity of the donor, including the donor code. When providing this information to NSW Health the correct form
must be used.
Where an application is made directly to NSW Health the ART provider may be directed to provide the information to NSW Health. Any information about the donor that is provided to NSW Health must be entered onto the Central Register.
The Surrogacy Act and Regulations commenced in early 2011.
The Surrogacy Act provides a framework for the Supreme Court to grant orders that transfer full legal parentage of children from their birth parent/s, to the intended parent/s under a surrogacy arrangement. The legislation also provides for certain information to be reported in relation to children born as a result of a surrogacy arrangement.
Intended parents must register information about themselves, their child and the surrogate, as well as any person who donated eggs or sperm or embryos, with the Central Register before the NSW Supreme Court will make a Parentage Order.
ART providers are required to provide details in relation to children born as a result of a surrogacy arrangement using a donated gamete or gametes.
What is the process to match voluntary information on the Central Register?
- Once an application has been verified through the required 100 point identification check, the NSW Ministry of Health will send the applicant’s details to the named ART provider to see whether the donor (or, where requested, other offspring from the same donor) can be identified. If the applicant does not list an ART provider, the NSW Ministry of Health will send the application to all registered providers in NSW.
- If the ART provider is able to identify the applicant, the ART Provider will return the following information to the Ministry of Health:
- Donor Code
- Donor’s date of birth
- Donor’s Blood Group
- Confirmation of the ART provider
The ART Provider will also indicate if the donor provided consent to being contacted when he or she donated the sperm, egg or embryo.
The NSW Ministry of Health will attempt to match the information received with a corresponding donor or donor offspring Central Register application.
Where a corresponding application is located, the NSW Ministry of Health will return both applications to the ART Provider for authentication of both records.
When an authenticated match has been made between donor and offspring/other offspring, the NSW Ministry of Health will notify the applicants via Registered Post that a match has been made. To ensure results are received in a supported way, the NSW Ministry of Health also provides applicants with information about the relevant ART Provider and how to access counselling.
Provision of Information to the Central Register
Where the donor consents to release of information the ART provider should keep the consent on file with the donor's information. There is no requirement that the information is provided to the NSW Ministry of Health.
The exchange of Voluntary information on the Central Register can only take place when both parties apply to the Central Register. When the NSW Ministry of Health receives an application for information from the Central Register the Ministry will contact the ART provider to request information to assist in identifying the relevant donor. At that stage the ART provider will provide the NSW Ministry of Health with the corresponding Donor Code, Blood Group, Date of Birth and confirmation of the ART facility. In addition the ART provider should also indicate whether at the time of donating, the donor gave express consent for the exchange of any information.
Once an authenticated match of information has been found the Ministry of Health will inform the applicant to contact the ART provider directly.
Is there a limit to how many women can use the same egg or sperm donor?
Yes, section 27 of the ART Act states that an ART provider must not provide ART treatment using a donated gamete if the treatment is likely to result in offspring of the donor being born, whether or not as a result of ART treatment, to more than five (5) women (or such lesser number as may be specified in the donor's consent), including the donor and any current or former spouse of the donor.
However this section does not prevent the provision of ART treatment using a donated gamete to a woman if the woman, or the spouse (including same sex and defacto spouse) of the woman, is the parent of a child born as a result of ART treatment using a donated gamete from the same donor.
ART providers can be prosecuted for failure to comply with the 5 women limit. It is a defence to a prosecution if the ART provider establishes it exercised due diligence to prevent the contravention. Due diligence includes searching records held by the ART provider, making reasonable inquiries of the donor and requesting information from other ART providers where there is reason to believe that another ART provider has been supplied with gametes provided by the donor. If an ART provider receives a request for information in relation to the 5 woman rule from another ART provider, the ART provider must provide the information requested or face prosecution.
ART providers can apply to the Ministry of Health for information to assist with compliance with the 5 woman rule. Such applications must be made on the appropriate form - Application by ART Provider for Information relating to Section 27.
5 Woman Rule and the Transitional Provisions
While section 27 of the ART Act creates a five women limit, Schedule 1, clauses 4A and 4B provide transitional provisions to allow women who had already started their families prior to the commencement of the ART Act to complete their families. The result of these provisions is that the five woman limit does not apply to prevent ART treatment being given to a woman if the gamete used in the treatment is a donated gamete that was obtained before the 1 January 2010 and:
- the woman has, before 1 January 2010, already conceived an offspring as a result of ART treatment using donated eggs or sperm from the donor, or
- the woman has an embryo in storage that was created prior to 1 January 2010 using a donated gamete for the purpose of providing ART treatment to her.
Reporting requirements for embryos created prior to 1 January 2010
Where an ART provider has embryos in storage that were created using donated sperm and eggs before 1 January 2010 the transitional reporting provisions will apply if the embryo was created before 1 January 2010 for the purpose of providing ART treatment to a particular woman and the embryo is used to provide ART treatment to that woman.
In those circumstances the donor’s information will NOT be included on the Central Register. However donors may decide to include their information in the Central Register voluntarily.
Use of gametes donated prior to 1 January 2010
Transitional provisions apply to allow women who started their families prior to the commencement of the ART Act to complete their families. This means that where a woman conceived a child prior to 1 January 2010 as a result of ART treatment using donated eggs or sperm she can have ART treatment using the same donor's gamete without the reporting requirements of the ART Act applying to any offspring resulting from such treatment.
Donors may decide to include their information on the Central Register voluntarily.