Assisted Reproductive Technology and the Law: A Study with Special Reference to Legal Regulation of Surrogacy

Assisted Reproductive Technology and the Law

Written by Neetu Lather

Introduction

Commonly, ART treatment includes combining in the laboratory, the eggs removed by surgery from a woman’s ovaries and sperm, and returning the combination to the woman’s body, or donating them to another woman (a surrogate or gestational carrier). A surrogate is a woman who with the male partner’s sperm of the couple becomes pregnant. A gestational carrier is a woman with the female partner’s egg and the male partner’s sperm becomes pregnant[1].

Sometimes donor sperm, donor eggs, or previously frozen embryos are also used in ART treatment. Procedure in which a woman is on medication only for stimulating egg production without the intention of having eggs retrieved or only sperm handling procedure (i.e., intrauterine or artificial insemination) is not included in ATR. Multiple pregnancies is the most common complication of ART, for its prevention, the number of embryos that are put into the woman’s body can be limited.

The Assisted Reproductive Technology (Regulation) Bill, 2020, is the latest legislation, which was introduced in the Lok Sabha following the advice of a Rajya Sabha Select Committee on the Surrogacy (Regulation) Bill, 2019, which recommended that an ART law precede the Surrogacy Bill[2].

The Assisted Reproductive Technology (ART) Regulation Bill 2020 has been brought up to the standing committee on health and family welfare for examination. Laid on the Table of Lok Sabha and Presented to the Rajya Sabha on 19th March 2021.

Assisted Reproductive Technology (ART)

According to Fertility Clinic Success Rate and Certification Act, 1992 ART is all fertility treatments in which either eggs or embryos are handled.

According to The ART (Regulation) Bill, 2020 ART include all techniques that seek to obtain a pregnancy by handling the sperm or the oocyte (immature egg cell) outside the human body and placing the embryo into the woman’s body.  Gamete donation, in-vitro-fertilisation, zygote intrafallopian transfer, and gestational surrogacy are some examples of ART services which is provided through ART clinics and ART banks.

Negative effects of ART

ART procedures are invasive to women’s bodies, can be medically risky for both the woman and the child born as are not backed by robust evidence of effectiveness and safety. These risks and harms, particularly to women, are worse in an environment where unfettered profit motives drive fertility services.

Clinics many times overstate the success rates of treatments, do not provide adequate information on the risks, costs, side effects, alternatives to procedures, and encourage overtreatment.  This negligence has resulted in the deaths of oocyte donors in some cases.

A timely step addressing these concerns is required, which can be The ART Bill, promote reproductive autonomy and protect the rights of service users through clear standards and protocols for treatment and care.

The ART (Regulation) Bill, 2020

This Bill is the most recent in a series of similar proposed legislation proposed in the last 12 years. The objective behind the bill is to regulate and supervise ART clinics and banks, prevent exploitation of affected women and children, and prevent misuse and promote safe and ethical use of such services.

  • Registration of ART clinics and banks: According to the Bill registration of every ART clinic and the bank is a must under the National Registry of Banks and Clinics of India.  The National Registry will be established under the Bill and will act as a central database with details of all ART clinics and banks in the country.  Registration authorities will be appointed by the state government for facilitating the registration process.  Clinics and banks will be registered only if they adhere to certain standards (specialised manpower, physical infrastructure, and diagnostic facilities) are mandatory to be adhered to by clinics and banks for registration.  The registration validity is for 5 years and can be renewed for a further five years. In case the entity contravenes the provisions of the Bill, the Registration may be cancelled or suspended[3].
  • Conditions for gamete donation and supply: Screening of gamete donors, collection and storage of semen, and provision of oocyte donors can only be done by a registered ART bank.  In bank, male between 21 and 55 years of age can give semen, and female between 23 and 35 years of age can give oocytes.  An oocyte donor should be an ever-married woman having at least one alive child of her own(minimum three years of age). Oocyte can be donated by the woman only once in her life and not more than seven oocytes can be retrieved from her. Gamete of a single donor can’t be supplied by the bank to more than one commissioning couple (couple seeking services).
  • Conditions for offering ART services: ART procedures can only be carried out with the written informed consent of both the party seeking ART services as well as the donor.  The party seeking ART services will be required to provide insurance coverage in the favour of the oocyte donor (for any loss, damage, or death of the donor).  A clinic is prohibited from offering to provide a child of pre-determined sex.  The Bill also requires checking for genetic diseases before embryo implantation.
  • Rights of a child born through ART:  A child will be deemed to be a biological child of the commissioning couple and will have the same rights and privileges, which are available to a natural child of the commissioning couple. A donor can’t claim any parental rights over the child.
  • National and State Boards: The Bill provides that the National and State Boards for Surrogacy constituted under the Surrogacy (Regulation) Bill, 2019 will act as the National and State Board respectively for the regulation of ART services.  Key powers and functions of the National Board include: advising the central government on ART-related policy matters; reviewing and monitoring the implementation of the Bill; formulating code of conduct and standards for ART clinics and banks, and overseeing various bodies to be constituted under the Bill.  The State Boards will coordinate enforcement of the policies and guidelines for ART as per the recommendations, policies, and regulations of the National Board.
  • Offences and penalties: Offences according to the Bill include abandoning, or exploiting children born through ART; selling, purchasing, trading, or importing human embryos or gametes; using intermediates to obtain donors; transferring the human embryo into a male or an animal; and exploiting commissioning couple, woman, or the gamete donor in any form.  Punishment for these offences will be fine between 5 and 10 lakh rupees for the first contravention; and imprisonment for a term between 8 and 12 years, and a fine between 10 and 20 lakh rupees for subsequent contraventions.
  • Punishment for any clinic or bank advertising or offering sex-selective ART will be imprisonment between 5 and 10 years, or fine between Rs 10 lakh and Rs 25 lakh, or both. 
  • No cognisance of offences will under the Bill be taken by the court, except on a complaint made by the National or State Board or any officer authorised by the Boards. [4]

Issues in Bill and Suggestions-According to Bill, the discretion to establish a national registry of ART clinics and banks are with the Central government. The registry will consist of a database of all ART clinics and banks, services offered by them, and outcomes of their services in the country. While seeking ART services, such information is important to clients for informed decision marking, so it’s suggested that the Registry must be mandatorily established and publicly accessible.

The Bill has mandated for clinics to provide some important information to clients to make informed decisions. It’s suggested that obligation should be there on Clinics to provide additional information such as the actual success rates of the procedure in the clinic as well as nationally and internationally etc.

It’s suggested that the reason for recommending a particular treatment should be given and should counsel clients about the possibility of adoption when it is in their best interests. Counselling should not be a one-time formality but an ongoing process. These elements were almost mentioned in previous versions, but are not mentioned in the present Bill.

The Bill bans the sale of gametes but does not shed light on how and from whom donor gametes are to be obtained. Further, the provision of counselling and accurate information about the harms, risks, and consequences of oocyte donation to donors are suggested to be mentioned.

The potential harm of Oocyte retrieval to the woman’s health is a fact which is also recognized in the bill. It’s suggested that the Bill must mandate counselling and written informed consent of the donor. While in the Bill it’s provided that insurance for the oocyte donor is there in case of damage or death during the process of retrieval, but does not specifically deal with the liability of banks and clinics in cases of negligence.

Data and privacy- It’s suggested that the Bill must provide robust protections for client data.

Equitable access- The Bill only allows married couples and (perhaps) single unmarried women to access ARTs but not to single men, transgender and intersex individuals, and those in live-in and queer relationships which is discrimination and interferes in the reproductive autonomy and privacy for them.

It’s suggested that government should allow meaningful and widespread public consultation on the Bill, and draft or change law that will be responsible for the rights and health of ART users[5].

Conclusion

The Assisted Reproductive Technology (ART) Regulation Bill 2020, which aims to regulate clinics offering IVF and other assisted reproductive services in the country, has been referred to the standing committee on health and family welfare for examination. The committee was asked to report with their suggestions within three months.

129th report on the Assisted Reproductive Technology (Regulation) Bill, 2020 has been presented to the Rajya and Laid on the Table of Lok Sabha on 19th March 2021. The Committee is of the view that clause 1 dealing with the short title as Act may be called the Assisted Reproductive Technology (Regulation) Act, 2021 and commencement is of procedural as will come in existence when the Central Government may, by notification in the Official Gazette, appoint and consequential nature shall apply to the entire territory of India.

About the Author

Assisted Reproductive Technology and the Law: A Study with Special Reference to Legal Regulation of Surrogacy

Neetu Lather

Student at Vivekananda School of Law and Legal Studies, VIPS.

She has participated in various academic events including moot court Competitions and completed the Legal Drafting and Office Management Course at Vivekananda Institute of Professional Studies. Her areas of interest and research work are Constitutional Law, Competition Law, Criminal Law, Intellectual Property Rights and International law.


[1]CDC Centers for Disease Control and Prevention, Assisted Reproductive Technology(ART)(3Oct2021), https://www.cdc.gov/art/whatis.html

[2]Eeshan Sonak, Sanvi Bhatia, India’s new Surrogacy Regulation Bill falls short of protecting bodily autonomy and guaranteeing reproductive liberty, LSE,(30Sep2021), https://blogs.lse.ac.uk/humanrights/2021/04/21/indias-new-surrogacy-regulation-bill-falls-short-of-protecting-bodily-autonomy-and-guaranteeing-reproductive-liberty/

[3] Prabha Kotiswaran, Assisted Reproductive Technology Bill needs a thorough review, The Indian EXPRESS,(30sep2021), https://indianexpress.com/article/opinion/columns/assisted-reproductive-technology-regulation-bill-surrogacy-6716444/

[4]PRS LEGISLATIVE RESEARCH, The Assisted Reproductive Technology (Regulation) Bill, 2020,(30Sep2021),https://prsindia.org/billtrack/the-assisted-reproductive-technology-regulation-bill-2020

[5] Support Scroll.in, Bill to regulate fertility treatments is much needed – but fails to address legal, ethical concerns,(30Sep2021), https://scroll.in/article/975597/bill-to-regulate-fertility-treatments-is-much-needed-but-fails-to-address-legal-ethical-concerns

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