Union Health Minister Harsh Vardhan introduced the Assisted Reproductive Technology (Regulation) Bill, 2020 (Bill) in the Lok Sabha on September 14. Its aim is to regulate ART banks and clinics, allow safe and ethical practice of ARTs and protect women and children from exploitation. The Bill was introduced to supplement the Surrogacy (Regulation) Bill, 2019 (SRB), which awaits consideration by the Rajya Sabha after review by two parliamentary committees. Fifteen years in the making, the ART Bill is unsatisfactory and fails to respond to the needs of the 27 million infertile Indian couples.
What is ART Bill?
ART is used to treat infertility. It includes fertility treatments that handle both a woman’s egg and a man’s sperm. It works by removing eggs from a woman’s body. The eggs are then mixed with sperm to make embryos. The embryos are then put back in the woman’s body. In Vitro fertilization (IVF) is the most common and effective type of ART. ART procedures sometimes use donor eggs, donor sperm, or previously frozen embryos. It may also involve a surrogate carrier.
The bill makes provisions for safe and ethical practice of assisted reproductive technology services in the country. The Bill will ensure confidentiality of intending couples and protect the rights of the child born through ART.
Pre-Genetic Implantation Testing Mandatory, The test allows doctors to test embryos for any possible abnormal chromosomes before they are transferred to the uterus. This is to avoid any genetic diseases in the population born through these technologies.
A National Board which will lay down a code of conduct to be observed by those operating ART clinics. The Board will also formulate minimum standards for laboratory and diagnostic equipment and practices to be followed by human resources employed by clinics and banks. ART Bank means an organization that is set up to supply sperm/semen, oocytes/oocyte donor and surrogate mothers to Assisted Reproductive Technology clinics or the patients.
A national registry and registration authority, which will maintain a database to assist the national Board to perform its functions
what are the Concerns regarding the Bill?
The first concern is who can access ART. The Bill allows for a married heterosexual couple and a woman above the age of marriage to use ARTs. It excludes single men, cohabiting heterosexual couples and LGBTQI individuals and couples from accessing ARTs. This violates Article 14 of the Constitution and the right to privacy jurisprudence of Puttaswamy, where the Supreme Court held that “the sanctity of marriage, the liberty of procreation, the choice of a family life and the dignity of being” concerned all individuals irrespective of their social status and were aspects of privacy. In Navtej Johar, Justice Chandrachud exhorted the state to take positive steps for equal protection for same-sex couples. Unlike the SRB, there is no prohibition on foreign citizens accessing ARTs. Foreigners can access ART but not Indian citizens in loving relationships. This is an illogical result which fails to reflect the true spirit of the Constitution.
The ART Bill does not do what it says on the label. It does little to protect the egg donor. Harvesting of eggs is an invasive process which, if performed incorrectly, can result in death. The Bill requires an egg donor’s written consent but does not provide for her counselling or the ability to withdraw her consent before or during the procedure (unlike for commissioning parties). She receives no compensation or reimbursement of expenses for loss of salary, time and effort. Failing to pay for bodily services constitutes unfree labour, which is prohibited by Article 23 of the Constitution. The commissioning parties only need to obtain an insurance policy in her name for medical complications or death; no amount or duration is specified. The egg donor’s interests are subordinated in a Bill proposed in her name. The Bill restricts egg donation to a married woman with a child (at least three years old). Even here, egg donation as an altruistic act is possible only once a woman has fulfilled her duties to the patriarchal institution of marriage.
Children born from ART do not have the right to know their parentage, which is crucial to their best interests and protected under previous drafts.
Although the Bill and the SRB regulate ARTs and surrogacy, respectively, there is considerable overlap between both sectors. Yet the Bills do not work in tandem. Core ART processes are left undefined; several of these are defined in the SRB but not the Bill. Definitions of commissioning “couple”, “infertility”, “ART clinics” and “banks” need to be synchronised between the Bills. A single woman cannot commission surrogacy but can access ART. The Bill designates surrogacy boards under the SRB to function as advisory bodies for ART, which is desirable. However, both Bills set up multiple bodies for registration which will result in duplication or worse, lack of regulation (e.g. surrogacy clinic is not required to report surrogacy to National Registry). Also, the same offending behaviours under both Bills are punished differently + punishments under the SRB are greater. Offences under the Bill are bailable but not under the SRB. Finally, records have to be maintained for 10 years under the Bill but for 25 years under the SRB. The same actions taken by a surrogacy clinic and ART clinic (likely to be the same entity) attract varied regulation.
Previous versions of the Bill required independence between ART banks and ART clinics. There is no such distinction now. Where gamete donation is not compensated, how will ART Banks be economically viable? Perhaps clinics are allowed to operate banks and subsidise them through ART services? In previous drafts, gametes could not be gifted between known friends and relatives. Has this changed since the Bill has shifted to an altruistic model of gamete donation? Either way, gamete shortage is likely. Further, the Bill’s prohibition on the sale, transfer, or use of gametes and embryos is poorly worded and will confuse foreign and domestic parents relying on donated gametes.
The Bill requires clinics and banks to maintain a grievance cell but these will be one-sided. Clinics must instead have ethics committees. Mandated counselling services should also be independent of the clinic. The SRB and the Bill impose high sentences (8-12 years) and hefty fines. The poor enforcement of the PCPNDT Act, 1994, demonstrates that enhanced punishments do not secure compliance — lawyers and judges also lack medical expertise. Patients already sue fertility clinics in consumer redressal fora, which is preferable to criminal courts. Unusually, the Bill requires all bodies to be bound by the directions of central and state governments in the national interest, friendly relations with foreign states, public order, decency or morality — being broadly phrased, it undermines their independence.
The Bill raises several constitutional, medico-legal, ethical and regulatory concerns, affecting millions and must be thoroughly reviewed before passage.
