When we talk about implications of Assisted Reproductive Technology (ART) in India, it becomes essential to take a look at ART available in other countries. This paper focuses on ART in two commonwealth countries namely United Kingdom as well as Australia. Also while understanding laws relating to ART in these two countries we need to keep in mind whether any ART provisions in these countries can be incorporated in Indian law.
I. UNITED KINGDOM:
In U.K, Human Fertilization and Embryology Act 1990 was the first ever act which reflected public and professional interest in the potential future of human embryo research and assisted reproduction treatment. The Human Fertilisation and Embryology Authority (HFEA) a statutory body, was created in 1991 under the Human Fertilization and Embryology Act 1990.
Human Fertilisation and Embryology Authority (HFEA):
Role of HFEA:
- To license and monitor fertility clinics that carry out in vitro fertilisation (IVF) and donor insemination
- To license and monitor centres undertaking human embryo research
- To license and monitor the storage of gametes and embryos
- To produce a Code of Practice which gives guidelines to clinics about the proper conduct of HFEA licensed activities
- To maintain a formal register of information about donors, fertility treatments and children born as a result of those treatments
- To provide relevant advice and information to patients, donors and clinics
- To monitor any subsequent developments in this area and where appropriate, advise the Secretary of State for Health on developments in these fields
- In U.K many treatments are licensed. E.g.: Donor Insemination (DI) ,In Vitro Fertilisation (IVF) , Gamete Intra-Fallopian Transfer (GIFT) (with donor and partner sperm and eggs) ,Intra Cytoplasmic Sperm Injection (ICSI) , Assisted Hatching (chemical), Assisted Hatching (mechanical) ,Assisted Hatching (laser).
Donor Conceived People:
It is interesting to note that a person born through ART has the right to know at the time of marriage if he is genetically related to his partner. Also after such a person has attained the age of 18 he can ask for identifying information about his donor. E.g. donor’s full name, date of birth, last address where donor lived etc.What are the chances of an ART conceived child getting married to his own brother or sister? In India since this technology is in its infancy such problem would be rare, but in UK ART conceived people are large in number and hence they must have felt the need of including such information. We can amend our marriage laws of India and including as one more requisite of valid marriage, that ‘ marriage between two persons shall be solemnised provided they are not genetically related through ART’.
I know it is kind of far fetched as of now but we might have to think on those lines sometime later.
Responsibility on Clinics:
Under the 1990 Human Fertilisation and Embryology Act, clinics have a responsibility to make an assessment of the welfare of any child or existing children before they can provide treatment to a woman. The HFEA provides guidance to clinics on how this assessment should be carried out.
According to Section 13 (5):
A woman shall not be provided with treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for a father) and of any other child who may be affected by the birth.
Relevant risk factors
In order to take into account the welfare of the child, treatment centres are expected to consider factors which are likely to cause serious physical, psychological or medical harm, either to the child to be born or to any existing child of the family. These factors should include:
(I) Any aspect of the patient’s past or current circumstances, which means that either the child to be born or any existing child of the family is likely to experience serious physical or psychological harm or neglect. Such aspects might include:
(a) Previous convictions relating to harming children;
(b) Child protection measures taken regarding existing children; or
(c) Serious violence or discord within the family environment.
(ii) Any aspect of the patient’s past or current circumstances which is likely to lead to an inability to care for the child to be born throughout its childhood or which are already seriously impairing the care of any existing child of the family. Such aspects might include:
(a) Mental or physical conditions; or
(b) Drug or alcohol abuse.
(iii) Any aspect of the patient’s medical history which means that the child to be born is likely to suffer from a serious medical condition.
(iv) any other aspects of the patient’s circumstances which treatment centres consider to be likely to cause serious harm to the child to be born or any existing child of the family.
Where the child will have no legal father, the treatment centre is expected to assess the prospective mother’s ability to meet the child’s/children’s needs and the ability of other persons within the family or social circle willing to share responsibility for those needs.
SURROGACY ARRANGEMENT ACT 1985:
This act bans commercial surrogacy in United Kingdom. It prohibits taking part in negotiations with a view to make surrogacy arrangement, advertisement which contain indication that a person is or may be willing to enter into a surrogacy arrangement or that any person is looking for a woman willing to become a surrogate mother. Where a newspaper or periodical containing such advertisement is published in the United Kingdom, any proprietor, editor or publisher of the newspaper or periodical is guilty of an offence.
DONOR CONCEPTION NETWORK:
DC NETWORK is a group started in 1993 by parents who had decided to tell their children about their origins. In our discussions we also dealt with this issue at length that should parents tell their children about how they were conceived or should it be upto their own discretion?
The interests of offspring in knowing their genetic and gestational roots conflict with the desire of donors, surrogates and recipients for privacy. In India, disclosure of confidential medical information may be justified in some circumstances. Where life, safety, well-being or other important interests are in jeopardy, it will be justified to disclose the information.
HUMAN FERTILSATION AND EMBRYOLOGY ACT 2008:
This act is yet to come into force. Section 4A of this act talks about:
Prohibitions in connection with genetic material not of human origin
(1) No person shall place in a woman—
(b) any other embryo that is not a human embryo, or
(c) any gametes other than human gametes.
(2) No person shall—
(a) mix human gametes with animal gametes,
(b) bring about the creation of a human admixed embryo, or
(c) keep or use a human admixed embryo, except in pursuance of a licence…
Embryo Testing:
Section 3 (1ZA) gives list of situations where embryo testing is allowed.
(a) Establishing whether the embryo has a gene, chromosome or mitochondrion abnormality that may affect its capacity to result in a live birth,
(b) in a case where there is a particular risk that the embryo may have any gene, chromosome or mitochondrion abnormality, establishing whether it has that abnormality or any other gene, chromosome or mitochondrion abnormality,
(c) in a case where there is a particular risk that any resulting child will have or develop—
(i) a gender-related serious physical or mental disability,
(ii) a gender-related serious illness, or
(iii) any other gender-related serious medical condition, establishing the sex of the embryo,
(d) in a case where a person (“the sibling”) who is the child of the persons whose gametes are used to bring about the creation of the embryo (or of either of those persons) suffers from a serious medical condition which could be treated by umbilical cord blood stem cells, bone marrow or other tissue of any resulting child, establishing whether the tissue of any resulting child would be compatible with that of the sibling, and
(e) in a case where uncertainty has arisen as to whether the embryo is one of those whose creation was brought about by using the gametes of particular persons, establishing whether it is.
Sex Selection
Section 3 (1ZB) prohibits use of ART for sex selection.
(1) A licence under paragraph 1 cannot authorise any practice designed to secure that any resulting child will be of one sex rather than the other.
(2) Sub-paragraph (1) does not prevent the authorisation of any testing of embryos that is capable of being authorised under paragraph 1ZA.
(3) Sub-paragraph (1) does not prevent the authorisation of any other practices designed to secure that any resulting child will be of one sex rather than the other in a case where there is a particular risk that a woman will give birth to a child who will have or develop—
(a) a gender-related serious physical or mental disability,
(b) a gender-related serious illness, or
(c) any other gender-related serious medical condition.
II. AUSTRALIA
Australia has a federal system of governance. As a result power is distributed between the centre and states. Policies addressing human genetic and reproductive technology are made at both federal and state levels. Different states in Australia have different laws regulating ART. The National Health and Medical Research Council (NHMRC) is the national body responsible for advising the Australian community and Commonwealth and State governments on standards of individual and public health and supports research to improve those standards. In September 2004 the revised NHMRC Ethical guidelines on the use of Assisted Reproductive Technology in Clinical Practice and Research were released. States must comply with the NHMRC Guidelines unless specific legislation regulating reproductive technology overrides. This paper tries to compare laws on ART in different states with respect to few common points.
NEW SOUTH WALES (NSW):
As far as NSW is concerned, there are few clauses in Human Tissues Act 1983 which incorporate some aspects of ART. The NSW government has released a discussion paper that canvases the need for legislation to govern reproductive technology practice and research.
NSW Law Reform Commission Report 1988(LRC) talks about different aspects of ART
Code of Practise:
In NSW, there are no requirements for a registered medical practitioner or a clinic to hold a licence to perform any ART. Medical practitioners who do practice ART have certain guidelines which they should follow, although there is no legal sanction involved in the event of a breach of these Guidelines.
2. Counselling to patients:
The LRC recommended that counselling should not be made compulsory for every IVF patient. However, it should be a compulsory condition of practice licences that adequate counselling facilities be available and be formally offered to all IVF clients.
3. Embryos for research and other purposes:
The LRC was of the view that there should be no legislative prohibition upon the creation of embryos solely for the purpose of research. In NSW there is a State wide Health Confidentiality and Ethics Committee which is organised and chaired by the Department of Health. It is constituted as an ethics committee under NHMRC Guidelines. The LRC considered the practices of cloning and trans-species fertilisation as abhorrent and was of the view that they should be strictly prohibited by legislation.
4. Disposal of gametes:
The power to deal with and dispose of sperm and ova produced for IVF should vest in the respective gamete providers. In the case of an unconditional donation of gametes, the power to determine the use, storage and disposal of gametes should vest in the clinic.
5. Storage period:
The LRC recommended that, within the proposed storage limit of ten years, the stored embryo should not be used, dealt with or disposed of unless the couple for whom the ovum was fertilised agree.
6. Gametes of deceased person:
There is no prohibition to use IVF procedures to achieve pregnancy with the stored gametes of deceased person.
7. Access to information:
As far as access to non-identifying information is concerned, there is no need of consent. However access to identifying information should only be possible with the consent of the person whose identity was to be revealed
8. Surrogacy:
There is no legislation in NSW which regulates surrogacy. Surrogacy is not specifically prohibited in NSW. The LRC was of the view that the practice of surrogacy was undesirable because:
• It involves the deliberate creation of new life for the purpose of alleviating infertility;
• The body of a woman is put to the service of the commissioning parties;
• The practice entails the planned separation of child and birth mother, at a very early age and permanently;
• Both the woman who is to act as the surrogate and the woman who commissions the child are placed at significant risk by the process because of the possibility of moral pressure being exerted on them to comply.
• The legal recognition and enforcement of a surrogacy agreement is inconsistent with the philosophy that in all cases concerning guardianship or custody, the welfare of the child should be the paramount consideration.
The LRC recommended that all forms of commercial surrogacy should be prohibited. It should be an offence to pay, receive, offer or solicit any reward for participation in, or facilitation of, a surrogacy arrangement or any part of a surrogacy arrangement.
The LRC recommended that anyone who publishes or causes to be published a statement or advertisement offering or soliciting participation in a surrogacy arrangement should be guilty of a criminal offence. The LRC also recommended that surrogacy agreements should be void and unenforceable at law.
VICTORIA
The Victorian Government introduced their Infertility Treatment Act 1995 (Vic) in 1995. The Infertility Treatment Authority licenses places where treatment is provided and approves doctors, embryologists, research scientists and counsellors.
Victorian Law Reform Commission
The Victorian Law Reform Commission (VLRC) has made recommendations to expand eligibility criteria to include social infertility and also allow same sex couples to adopt.
Infertility Treatment Act 1995:
Eligibility Criteria:
This act requires that to access treatment, a couple must be in a heterosexual de facto relationship, and considered by their doctor to be infertile, or wishing to prevent the transfer of a genetic abnormality or disease. Informed consent must be given to the treatment proposed, by the woman and her spouse.
Until recently, the Victorian Act required that a woman who undergoes a treatment procedure must be married. Marriage was not defined to include a de facto relationship, and therefore only legally married couples could have access to ART. Subsequent to the decision of
MW v Royal Women’s Hospital <!–[if !supportFootnotes]–>[1]<!–[endif]–> the Act was amended to extend access to de facto couples.
Counselling to patients:
In Victoria, a woman and her husband or de facto partner must have received counselling from an approved counsellor prior to undergoing a treatment procedure, as must donors of gametes and embryos.
3. Embryo for research purposes:
The Victorian legislation prohibits research, outside the body of a woman, involving the use of an embryo if the embryo is unfit for transfer to a woman, or in the case of an embryo which is fit for transfer to a woman, if the research would harm the embryo, or make the embryo unfit for transfer to a woman, or reduce the likelihood of pregnancy resulting from the transfer of the embryo. These prohibitions do not apply to zygotes, although approval for research on zygotes is required under the Act. Victoria has banned cloning and Trans species fertilisation.
4. Storage of Gametes:
The Victorian Act provides that gametes must not remain in storage for more than 10 years or such longer period approved by the Infertility Treatment Authority.
5. Gametes of deceased person:
The Victorian Act prohibits the use of gametes from a dead person or the transfer of embryos formed from the gametes of a dead person. This would prevent a woman being inseminated with her dead husband/partner’s stored sperm or having an embryo formed using her dead husband/partner’s stored sperm or having a stored embryo which was formed with her husband/partner’s sperm when he was alive transferred to her body after his death.
6. Access to information:
Victorian act provides for a central register of information in relation to procedures involving donor gametes and embryos. Donors and parents of offspring born as a result of donor procedures can access non-identifying information as to recipients/donors as of right from the central register. Identifying information can be accessed with the consent of the person to whom the information relates. Children born as a result of donor procedures and their offspring can access both identifying and non identifying information as of right.
7. Surrogacy:
The Victorian Infertility Treatment Act 1995 prohibits any commercial surrogacy arrangement, making it an offence to give or receive any payment or reward under a surrogacy agreement or for arranging a surrogacy agreement or for acting as a surrogate mother. The Act also prohibits advertising surrogacy services (either to act as a surrogate, or to seek a surrogate or facilitate a surrogacy agreement). All surrogacy agreements are void.
WESTERN AUSTRALIA
The Human Reproductive Technology Act 1991(WA) and the Amendment Act 1996 allows treatment for infertile de facto and legally married couples and single women or for the prevention of the transfer of genetic diseases. WA legislation regards the child’s interests as just a factor amongst others.
1. Code of practise:
In Western Australia, a licence to carry out Artificial Insemination (AI) is not required (as it is for other kinds of ART) if the procedure is carried out by a medical practitioner who has applied for exemption from the licensing requirement. The practitioner must notify the Commissioner of Health of the procedures to be carried out and lodge an undertaking to observe and comply with the Code of Practice and any directions made under the Act. The licence is issued on the advice of a body set up under the Act called the Reproductive Technology Council.
2. Eligibility Criteria:
In Western Australia, ART is not available to a couple unless they are, or appear to be, infertile or there is a risk that a genetic defect would be transmitted to the child if conceived naturally. Directions under the Western Australian Act provide that the medical practitioner treating the patient makes the final decision as to the eligibility of any participant on both legal and medical grounds.
Counselling:
In Western Australia, each participant must be given a suitable opportunity to receive proper counselling about the implications of the proposed procedures and other relevant and suitable information as is proper or as may be specifically required by the code or directions.
4. Research on embryo:
In Western Australia, it is an offence to carry out research upon a fertilising egg, or an embryo without obtaining approval from the Council. Research which is not therapeutic to the embryo may not be approved. Similarly creation of embryos for research is prohibited. Cloning and Trans species fertilisation is prohibited in Western Australia.
5. Storage of gametes:
Consent to store gametes must be renewed every 5 years up to a maximum of 15 years, although an extension may be granted by the Council.
6. Disposal of gametes:
In Western Australia, gamete donors have rights of control over their own gametes and must consent to any storage or use of the gametes they have provided. Gametes may be donated, in which case these rights are passed on to the licensee or other recipient, who may only use those gametes as the Act allows.
7. Access to information:
No identifying information may be accessed from the registers kept under the Western Australian Act.
SOUTH AUSTRALIA
The parliament of SA has enacted the Reproductive Technology Act 1988 to regulate the use of reproductive technology and research involving experimentation with human reproductive material. This act has established the South Australian Council on Reproductive Technology. This council formulates a code of ethical practice to govern use of artificial fertilization procedures, research etc.
The objects of the Act require that “equity, welfare and general standards prevailing in the community are taken into account in the practice of reproductive technology”, and therefore a forum is provided for community debate on the issues raised by these technologies.
1. Eligibility Criteria:
Until recently, the South Australian Act provided that only married couples, defined to include two people living together as husband and wife who are not married and who have cohabited for five years (either continuously or over a six year period) can avail benefits of ART. The south Australian supreme courts decision in
Pearce v South Australian Health Commission2 dealt with a plaintiff, a woman separated from her husband, who was denied IVF treatment because she did not meet the marriage criteria described above.
The Court held that the provisions in the South Australian Act which prevented the application of procedures except for the benefit of married women were in direct conflict with the Sex Discrimination Act (Cth) 1984 which prohibits discrimination in the provision of goods and services on the grounds of marital status. Hence, the provisions of the South Australian Act were held to be invalid insofar as they conflicted with the Sex Discrimination Act, because of the operation of section 109 of the Commonwealth Constitution.
2. Counselling:
The South Australian Act does not make counselling mandatory. However, the Code of Practice requires adequate counselling to be given to the couple as to matters set out in the Code.
3. Research on embryo:
Research which is detrimental to embryo is prohibited. A person must not carry out research involving experimentation with human reproductive material except in pursuance of a licence granted by the council.
4. Storage of embryo:
The South Australian Code of Practice sets a time limit for storage of embryos of 10 years. A licensee must not keep an embryo in storage for the future use of a couple unless the couple have consented to that storage.
2 SA Supreme Court, SCGRG 1114 of 1996; S5801, 10
5. Disposal of embryos:
The South Australian Code of Practice provides that a licensee must not use reproductive material for any purposes unless the person who produced the material has consented to the use of the material for that purpose
A licensee must dispose of an embryo that is kept in storage for future use of a couple if either member of the couple dies, unless the storage consent specifies how an embryo is to be dealt with or disposed of in the event of death, in which case the licensee must deal with the embryo or dispose of it in accordance with those conditions.
6. Access to information:
Under the South Australian Act, a donor may consent to the disclosure of identifying information regarding themselves. A licensee may give non-identifying information regarding a donor to a person conceived from that donor’s genetic material over the age of 16, but must not disclose identifying information without the consent of the donor.
7. Surrogacy:
The South Australian Family Relationships Act 1975 provides that a surrogacy contract is illegal and void. However, penalties are attached only in relation to receiving commercial surrogacy contracts and advertising for surrogacy contracts.
Interpretation Act 1984
In one of our brainstorming sessions we discussed whether unmarried couples (live in couples) in India have a right to use ART. Our answer was negative since there were many issues involving child’s interest etc. moreover there was no concrete definition of live in relationships. However while writing this paper I came across Interpretation Act of 1984 which talks about de facto relationships and de facto partners.
(1) A reference in a written law to a de facto relationship shall be construed as a reference to a relationship (other than a legal marriage) between 2 persons who live together in a marriage-like relationship.
(2) The following factors are indicators of whether or not a de facto relationship exists between 2 persons, but are not essential —
(a) The length of the relationship between them;
(b) Whether the 2 persons have resided together;
(c) The nature and extent of common residence;
(d) Whether there is, or has been, a sexual relationship between them;
(e) The degree of financial dependence or interdependence, and any arrangements for financial support, between them;
(f) The ownership, use and acquisition of their property (including property they own individually);
(g) The degree of mutual commitment by them to a shared life;
(h) Whether they care for and support children;
(i) The reputation, and public aspects, of the relationship between them.
(3) It does not matter whether —
(a) The persons are different sexes or the same sex; or
(b) Either of the persons is legally married to someone else or in another de facto relationship.
CONCLUSION
Thus this paper summarises the law regulating ART in two of the major commonwealth countries. In India, as of now, there is no law governing ART and surrogacy however these facilities are used clandestinely. Absence of any concrete provisions to deal with such technologies leads to misuse and exploitation. There are chances of human trafficking of children born through ART. When such arrangements are not regularised and there are no checks and balances there is bound to be an illegal market for such facilities. It is high time we come up with laws regulating ART so that interest of children, donors, parents, surrogates are protected and preserved and those persons who are deprived of this natural gift of reproducing are able to fulfil their wishes using such technology.
References:
1. Acts-
(a) Human fertilisation and embryology authority (U.K)
(b) Human reproductive technology act 1991
(c) Human fertilization and embryology act 2008
(d) Infertility Treatment Act 1995 (Vic).
(e) Reproductive Technology Act 1988 (SA).
(f) Surrogacy arrangement act 1985 (U.K)
(g) Human fertilization and embryology act 1990
(h) Interpretation act 1984
3. publication-
(a) Discussion paper: assisted reproductive technologies (NSW health)
4. website-
(a) URL: http://www.dh.sa.gov.au/reproductive-technology/other.asp
(b) Donor conception network
<!–[if !supportFootnotes]–>[1]<!–[endif]–> Human Rights and Equal Opportunity Commission, H96/26, 96/33 and 96/48, A Kohl, Melbourne, 12 March 1997.
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