Section: E

Category: Legislative Analysis

Paper Code: LA-MB-04

Page Number: 481 - 485

Date of Publication: February 10, 2021

Citation: Masia Baruah, Analysis of the Assisted Reproductive Technology (Regulation) Bill, 2020, 1, AIJACLA, 481, 481-485, (2021).

Details Of Author(s):

Masia Baruah, Student BALLB 6th Semester, NERIM Law College

INTRODUCTION In the last few decades, there has been a spurt in the fertility industry in India with the development of advanced devices and procedures in the medical field. Assisted Reproductive Technology (ART hereinafter) is one such advancement.[1] In common parlance, ART is a procedure that provides infertile couples the opportunity of becoming parents of their children. WHO has defined it as “All procedures including in vitro handling of both human oocytes and sperm or embryo for purpose of establishing a pregnancy”.[2] The rising rates of infertility in couples, lengthy and difficult adoption procedures, and the urge for having one’s biological child have led to the growth of ART clinics and allied services in India outstripping western countries to become one of the major hubs of reproductive tourism attracting customers from around the globe.[3] With innumerable ART centers booming in every nook and corner providing a variety of services such as gamete donation, in-vitro fertilization, intra-cytoplasmic sperm injection, gestational surrogacy, etc., there has also arisen various ethical and legal issues connected with such services. Notably, there was neither any organization nor any regulatory framework to monitor these technologies, leading to the commercialization and codification of women’s body parts. In 2005, the National Guidelines for Accreditation, Supervision, and Regulation of ART Clinics in India was issued by the Indian Council of Medical Research laying down certain conditions to be followed by every ART clinic operating in India. However, these guidelines lacked legislative backing.[4] Thereafter in 2008 the Assisted Reproductive Technology Bill was proposed and was amended multiple times. Fortunately, its final version was approved by the Union Cabinet and was introduced in the Lok Sabha on September 14, 2020.[5] The Bill to be known as the Assisted Reproductive Technology (Regulation) Bill shall regulate and supervise the ART clinics and ART banks, prevent any misuse, and provide for the safe and ethical practice of ART services.[6]

PROVISIONS OF THE BILL Chapter I (Sections 1-2): This is the preliminary chapter which lays down several definitions of the various expressions used in the bill. Assisted Reproductive Technology has been defined as encompassing all techniques that attempt to obtain a pregnancy by handling the sperm or the oocyte outside the human body and transferring the gamete or the embryo into the reproductive system of a woman. ART Banks, ART Clinics, Commissioning couple have also been defined.

Chapter II (Sections 3-14): This chapter mentions the authorities to regulate ART and has been divided into 3 parts. Part A deals with the National Board set up under the Surrogacy (Regulation) Act 2020 which is empowered to lay down a code of conduct for ART Clinics along with the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by clinics and banks. Part B provides for the State Board set up under the Surrogacy Act having the responsibility to co-ordinate the enforcement and implementation of ART policies. Part C deals with the National Registry and State Registration Authorities. The former will act as a central database with the details of all ART clinics and banks to be obtained regularly and the latter is entrusted with the responsibility to grant, suspend or cancel the registration of a clinic or bank and is also empowered to investigate and take legal action against any misuse of ART.

Chapter III (Sections 15-20): It prescribes the procedures for the registration of ART clinics and banks. The Bill requires all existing ART Clinics and Banks operating in the country to be registered by making an application to the Registration Authority.

Chapter IV (Sections 21-31): This chapter enumerates several duties of ART Clinics and ART Banks such as providing professional counseling to commissioning couples. The Bill mandates the clinics to apply ART services only to a woman and a man above the legal age of marriage and below the age of 50 years and 55 years respectively. The ART procedures can be carried out only with the written consent of the parties seeking the services as well as the donor. Insurance is also required to be made in favor of the oocyte donor by the commissioning couple or woman (in case of any injury or death of the donor). The bill provides for Pre-implantation Genetic testing of the embryo before implantation to detect if any, pre-existing, heritable, or genetic disease. The bill allows the donation of gametes or embryos for research purposes in India only after the consent of the commissioning couple or woman or donor.

Chapter V (Sections 31-37): The Chapter stipulates the offense and penalties for the contravention of the provisions of the Bill. It strictly prohibits the ART Clinics and Bills to offer or facilitate any form of sex-selective ART and prescribes a punishment of imprisonment between five to ten years or a fine between Rs.10 lakh to Rs.20 lakh or with both in case of contravention. The bill also penalizes a series of practices such as abandoning or exploiting a child born through ART, selling, purchasing, trading, or importing of human gametes or embryos, transferring the human embryo into a male person or an animal, exploiting of commissioning couple, woman or donor, using intermediates to obtain donors with a fine between 5 lakh to 10 lakh for the first contravention but for subsequent contraventions the penalty is enhanced to imprisonment between 8 to 12 years and a fine between 10 lakh to 20 lakh.[7] LOOPHOLES IN THE BILL Although the Bill aims to affirm effective regulation of ART services for preventing exploitation of women, it has several potential blind spots. First, some of its provisions are inconsistent with the Constitution. The Bill prohibits single males, LGBTQ persons, and homosexual couples to access ART services. It also puts an age bar (50 years for women and 55 years for men) but does not specify any restrictions to foreign citizens. This classification based on age, gender, and sexual orientation is discriminatory to single males, same-sex couples, and couples who marry late and violative of their right to equality guaranteed under Article 14.[8] The bill also infringes on their right to privacy under Article 21. In Justice K S Puttaswamy v Union of India, the Apex Court had held that an individual must have the ability to control matters of home and marriage, the sanctity of family life, sexual orientation all of which were aspects of privacy.[9] Further, disentitling homosexual couples the right to commission a child is refusing to acknowledge their legitimacy which was recognized by the top court itself by setting aside section 377 of the Indian Penal Code[10]. Second, the bill lacks proper protection for oocyte donors. There is no provision in the Bill for her counseling. Though her written consent is needed to perform the ART procedures but unlike the commissioning couples she is not allowed to withdraw her consent before or during the procedure. Further, there is no specification as to the amount and duration of the insurance policy to be obtained in the favor of the oocyte donor by the commissioning parents. [11] Third, it mandates Pre-implantation Genetic testing of the embryo before implantation for finding out if the embryo suffers from any pre-existing, heritable or genetic disease but nowhere these disorders have been specifically defined. Moreover, unlike its previous versions, this Bill contains no regulatory provisions for research on donated gametes or embryos.[12] Fourth, though the Bill defines the term ART but various technical procedures falling under it like in-vitro fertilization, intra-cytoplasmic, sperm injection, and others have not been specified.

CONCLUSION The ART Bill is a welcoming step to safeguard women and children from exploitation. The provisions of compulsory registration of ART clinics and banks and the establishment of regulatory authorities both at the national and state levels would ensure proper regulation and monitoring of ART service centers. Additionally, the strict penalties stipulated would reduce the various immoral and illegal activities practiced by some ART centers such as sex determination of fetus or selling of gametes/embryos, etc. However, the Bill raises certain constitutional and medico-legal issues that need to be tackled and revised to the possible extent. Further, there is a considerable nexus between both ART and Surrogacy Bills 2020 concerning regulatory authorities and thus requires them to be well synchronized. If all the above-mentioned drawbacks are dealt with, the Bill if enacted can surely go a long way in securing the safe and ethical practice of ART services in India.

[1] Assisted Reproductive Technology (Regulation) Bill, 2020, (No. 97, 2020 India). [2] F.Zegers-Hochshild, G.D.Adamson,, International Committee for Monitoring Assisted Reproductive Technology(ICMART) and the World Health Organization (WHO) revised glossary of ART terminology 2009, 92, FER.AND.STER.,15201521,(2009). [3] Nikita Arya, This is Why the IVF Services Market is Booming in India, FRANCHISE INDIA, (Nov.2020, 13 09:30 PM), [4] Sarojini N B, Aastha Sharma, The draft ART (Regulation) Bill : in whose interest?, 6, IND. JRNL OF MDCL EHCS, (2009), [5] Alice George, Aviral Chauhan, Surrogacy Bill and ART Bill:Boon or Bane? INDIA CORPORATE LAW, (Nov.2020, 13 09:30 PM), [6] Supra note 1. [7] Supra note 1. [8] Assisted Reproductive Technology Bill needs a thorough review, APIRANT WORLD, (Nov. 2020, 13 09:30 PM), [9] Justice K S Puttaswamy v. Union of India, (2017) 10 SCC 1. [10] Navtej Singh Johar & Ors. v. Union of India AIR 2018 SC 4321. [11] Supra note 8. [12] Supra note 8.

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