Assisted Reproductive Technology (Regulation) Act, 2021: A timely legislation for a timeless problem

India’s convoluted and long tryst with assisted reproductive technology (ART) began in 1978 with the birth of India’s first test-tube baby, Kanupriya alias Durga in Kolkata. With this, began the growth of a multi-million dollar reproductive tourism industry. The industry grew exponentially, albeit without any congruent regulatory or legal framework to govern it.

There are over 40,000 ART clinics in the country as a conservative estimate. This led to myriad legal, ethical and social issues necessitating standardised protocol. The legislative vacuum was attempted to be filled by the Indian Council of Medical research (ICMR) in 2005 with the issuance of the National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India - the first ever national guidelines for laying down standards of conduct for surrogacy in India. The Ministry of Home Affairs has also periodically issued guidelines for regulating surrogacy. In 2009, the Law Commission in its 228th report recommended the enactment of legislation to facilitate the correct use of ART and legalization of surrogacy.

It is in this backdrop that Parliament on December 8, 2021 passed the Assisted Reproductive Technology (Regulation) Act, 2021, which received the assent of the President on December 18, 2021. The Act aims at the regulation and supervision of ART clinics and assisted reproductive technology banks, prevention of misuse, and safe and ethical practice of ART services.

Right alongside this Act comes the Surrogacy (Regulation) Act, 2021, which only recognises altruistic surrogacy as legal. While the Acts finally regulate the industry, they also bring in a number of concerns to the legal domain-including rights, scientific advances, cross-border surrogacies, obligations as well as ethical dilemmas.

Important highlights of the ART Act

Under the Act, every ART clinic and bank must be registered under the National Registry of Banks and Clinics of India. This Registry, comprising scientific and technical staff, will be a central database for all facilities providing ART services in India. State governments are required to appoint authorities to facilitate the registration process. No person/clinic/bank shall render ART procedures unless they are registered with the Registry.

The Act also provides for setting up of a National Reproductive Technology and Surrogacy Board, which shall lay down a Code of Conduct to be observed by persons working at ART clinics and banks and also set minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by clinics and banks. The Board shall also supervise the functioning of the Registry.

Additionally, the Act also lays down the duties to be performed by ART banks and clinics, which include ensuring that the commissioning couple, woman and donor are eligible to avail ART services; requiring clinics to obtain donors' gametes from banks which shall ensure that the donor has been tested for diseases; providing counselling services to commissioning couples and woman about the implications of ART; and rights of the child. A duty is imposed on the clinics and banks to keep the information of commissioning couples and women confidential and to maintain a grievance redressal cell. The Act also empowers the Central government to make rules to carry out the provisions of the Act as and when the need may arise.

Further, the Act provides for stringent punishment in the event of contravention of its provisions. First-time offenders may be liable to pay a fine between ₹5 lakh and ₹10 lakh, and for subsequent contraventions, the offender may be sentenced to imprisonment of 8 to 12 years and may also be liable to pay a fine of ₹10 to 12 lakh. Operators of clinics or banks offering or advertising sex selective ART may face imprisonment of 5 to 10 years or would also be liable to pay a fine of ₹10 to 25 lakh, or both.

Shortcomings of the ART Act

While the Act is a decisive and considerable step towards curbing the menace of illegal and unregulated ART clinics and towards safeguarding donors and women undergoing ART from the health implications faced due to unsafe and illegal procedures, it falls short of addressing some serious concerns.

First and foremost, the Act excludes unmarried men, divorced men, widowed men, unmarried yet cohabiting heterosexual couples, trans persons and homosexual couples (whether married or cohabiting) from availing ART services. This exclusion is relevant as the Surrogacy Act also excludes above said persons from taking recourse to surrogacy as a method of reproduction.

The Act is also limited to those commissioning couples who are infertile - those who have been unable to conceive after one year of unprotected coitus. Thus, it is limited in its application and significantly reduces the reproductive choices of those excluded. Third, the prices of the services are not regulated; this can certainly be remedied with simple directives.

Conclusion

As India is one of the major hubs of these practices, the Act is certainly a step in the right direction. There, however, needs to be a dynamic oversight to ensure that the law keeps up with rapidly evolving technology, demands of morality and societal changes. This piece of legislation will certainly have to be closely monitored over a course of time to assess its impact, strengths and shortcomings. It is certainly a landmark legislation that will pave way for moulding as well as reflecting the future course in this field.

Mehaak Jaggi is a Delhi-based independent legal practitioner.

Vishavjeet Chaudhary is an advocate, qualified Barrister-at-Law (The Hon’ble Society of the Inner Temple) and Door Tenant (Lamb Building, Temple, London).