The Indian Parliament’s lower house, Lok Sabha, has recently approved the Assisted Reproductive Technology (Regulation) Bill, 2021. This piece of legislation, which doesn’t apply to live-in couples, single men, and the members of LGBTQ+ community, was passed with the intention of supervising the Assisted Reproductive Technology (ART) industry.
The Bill’s Evolution
The Indian Council of Medical Research (ICMR) first drafted this legislation back in 2008. The bill was consequently introduced in Lok Sabha in 2020, but it was recommended for further review by a standing committee.
National Registry and Registration Authority
The new regulation proposes the establishment of a national registry and registration authority. This body is expected to maintain a database of all clinics and medical professionals who work in the ART domain. Under the proposed framework, state governments will be responsible for appointing registration authorities to facilitate the registration process. Every registration will remain valid for five years, with the possibility of renewal for an additional five-year term.
Rigorous Supervision of ART Services
An essential aspect of the bill is its determination to regulate ART clinics and banks meticulously. The goal is to prevent misuse and encourage the adoption of safe and ethical practices. As part of these efforts, a national board will be established. This board will develop minimum standards for physical infrastructure, laboratory equipment, diagnostic tools, and the expertise required by clinics and banks.
Stringent Penalties for Violations
The bill has provisions for strict punishment for anyone engaged in sex selection, human embryo or gamete sale, or the operation of agencies and organisations conducting such illegal activities. First-time offenders may face penalties ranging from Rs. 5 lakhs to Rs. 10 lakhs. Contrastingly, subsequent offences could result in imprisonment between eight and twelve years, in addition to fines between Rs. 10 lakhs and Rs. 20 lakhs.
Need for Regulation
The need for regulation arises due to the existence of numerous ART clinics operating without any supervision, which pose significant health risks to those who avail their services. Moreover, appropriate regulation would protect women and children involved in ART processes by providing insurance cover for oocyte donors and implementing strict rules for multiple embryo implantation.
Concerns Raised by the Bill
Despite its promising aspects, the bill has raised certain concerns. Firstly, it permits only married heterosexual couples and women over the age of marriage to use ART services, while excluding single men, live-in heterosexual couples, and LGBTQ+ individuals and couples from availing these services. Secondly, the bill overlaps with the Surrogacy Bill, as both aim to establish multiple regulatory bodies resulting in potential duplications or regulation inadequacies. Moreover, the bill’s silence on children’s rights and potential violation of Article 14 that ensures equality before law raises serious questions.
About Assisted Reproductive Technology (ART)
ART is a suite of fertility treatments that involve handling both a woman’s egg and a man’s sperm. Typically, it includes extracting eggs from a woman’s body, combining them with sperm to create embryos, and implanting the embryos back into the woman’s body. In Vitro Fertilization (IVF) is one of the most common and effective forms of ART. ART procedures can also sometimes comprise donor eggs, donor sperm, or previously frozen embryos, and may involve a surrogate carrier.
The Way Forward
For a more holistic implementation, it is crucial that ART clinics should have independent ethics committees and mandated counseling services. Prior versions of the legislation regulated research using embryos—a measure that this version should incorporate. Furthermore, the definitions of terms like “couple”, “infertility”, “ART clinics” and “banks” need to be harmonised with the Surrogacy (Regulation) Bill. Ultimately, a thorough review addressing all constitutional, medico-legal, ethical, and regulatory concerns raised by the bill is necessary before it affects millions in the country.