This article has been written by Oishika Banerji of Amity Law School, Kolkata. This article provides a detailed analysis of the Assisted Reproductive Technology (Regulation) Bill, 2020.

This article has been published by Rachit Garg.

Introduction 

When medical procedures are used in order to address infertility by remedying it with the help of Intracytoplasmic Sperm injection (ICSI), cryopreservation of gametes or embryos, In Vitro Fertilization (IVF), etc, the same is known as assisted reproductive technology. The Assisted Reproductive Technology (Regulation) Bill, 2020 was passed with amendments by the Lok Sabha on December 1, 2021, to prevent misuse and to ensure the safe and ethical practices of assisted reproductive technology services. The Bill, which was first introduced in the Lok Sabha on September 14, 2020, defines “assisted reproductive technology” as any technique that attempts to obtain a pregnancy by manipulating sperm or oocytes outside the human body and transferring the gamete or embryo into a woman’s reproductive system. The reason behind introducing such a Bill has been the absence of a set of standardized protocols or statutory enforcement in the field of reproductive medical tourism inspite of India’s significant contribution over the years to the global fertility industry. 

The Assisted Reproductive Technology (Regulation) Bill, 2020

The Assisted Reproductive Technology (Regulation) Bill, 2020 is spread over six chapters dealing with specific subject matters under the umbrella of ‘assisted reproductive technology’.  The Statement of Purpose of the Bill has been provided as, ‘for the regulation and supervision of the assisted reproductive technology clinics and the assisted reproductive technology banks, prevention of misuse, safe and ethical practice of assisted reproductive technology services and for matters connected therewith or incidental thereto’. Thus the objective of the Bill can be classified into the following heads: 

1. Regulating and supervising assisted reproductive technology,
2. Preventing misuse of the above-mentioned technology can be ensured by maintaining a safe and ethical practice with related to the same,
3. Regulate any matter that is connected or any way related to the aforementioned points.

The authorities which have been formed under this legislation draw their roots from the Surrogacy (Regulation) Act, 2020. Under this head, with reference to the Bill, an explanation has been provided with regards to the Bill, placing it under three different heads. 

Features of Assisted Reproductive Technology (Regulation) Bill, 2020

Some of the notable features of the Assisted Reproductive Technology (Regulation) Bill, 2020 have been provided hereunder.

1. Exhaustive definition of the term ‘assisted reproductive technology’: Section 2(b) to (e) provides a detailed list of inter-connected definitions namely, artificial insemination, assisted reproductive technology, assisted reproductive technology bank, and assisted reproductive technology clinic which signifies the objective and purpose of the Regulation Bill, 2020. The bill defines ‘assisted reproductive technology’ as any approach for obtaining a pregnancy by handling sperm or an oocyte (immature egg cell) outside the human body and transferring the gamete or embryo into a woman’s reproductive system. Gamete (sperm or oocyte) donation, in-vitro fertilization (fertilizing an egg in a lab), and gestational surrogacy are examples of ‘assisted reproductive technology’ services (the child is not biologically related to surrogate mother). ART services will be supplied by;

• ART clinics that conduct ART-related treatments and procedures, and
• ART banks that store and distribute gametes.

2. Formation of National and State Surrogacy Boards: The Surrogacy (Regulation) Bill, 2019, establishes the National and State Boards for Surrogacy, which will operate as the National and State Boards for the regulation of ART services, respectively. The National Board’s key powers and functions include:

• Advising the Central Government on ART-related policy matters,
• Reviewing and monitoring Bill’s implementation,
• Developing a code of conduct and standards for ART clinics and banks, and
• Supervising various bodies to be established under the Bill. 

The State Boards will coordinate the execution of ART rules and guidelines in accordance with the National Board’s recommendations, policies, and regulations.

3. Mandatory registration of clinics and banks: Chapter III of the Assisted Reproductive Technology (Regulation) Bill, 2020 lays down procedures for registration. Section 15(1) of the aforementioned Chapter mandates registration of clinics or banks for undertaking assisted reproductive technology or to render assisted reproductive technology procedures in any form. Further Section 15(2) provides that an application for registration under sub-section (1) shall be made to the National Registry through the State Board. This mandate acts as a check for any kind of improper or fraudulent use of the concerned technology which can harm the lives of people. 
4. The condition specified for donation and supply of gametes: Only a recognized ART bank is allowed to screen gamete donors, collect and store semen, and provide oocyte donors. Males between the ages of 21 and 55 can donate semen, while females between the ages of 23 and 35 can donate oocytes. An oocyte donor should be a happily married lady with at least one living child (minimum three years of age). A woman can only contribute one oocyte once throughout her life, and she can only have seven oocytes extracted from her. A single donor’s gamete cannot be sent to more than one commissioning couple by a bank (couple seeking services).

Rights and liabilities vested by Assisted Reproductive Technology (Regulation) Bill, 2020

Chapter IV of the Assisted Reproductive Technology (Regulation) Bill, 2020 lays down the duties vested on the assisted reproductive technology clinic and assisted reproductive technology bank along with the rights of a child born by means of this technology. 

Rights of a child born by means of the assisted reproductive technology

1. The child born through assisted reproductive technology is presumed to be the commissioning couple’s biological child, and the said child is entitled to all of the rights and privileges afforded to a natural child only from the commissioning couple under any legislation in effect at the time.
2. A donor relinquishes all parental rights over the child or children resulting from his or her gamete.

Duties vested by the Assisted Reproductive Technology (Regulation) Bill, 2020

The duties vested on assisted reproductive technology clinics and banks have been discussed under three broad heads, namely, general duties, duties of assisted reproductive technology clinics and banks to keep accurate records, and duties of assisted reproductive technology clinics using human gametes and embryos. 

General duties

1. The clinics and banks must ensure checks on the eligibility of the commissioning couple to avail of the assisted reproductive technology procedures.
2. The clinics must ensure that the donor is medically capable and disease-free. 
3. It is the duty of the clinics to communicate every assisted reproductive technology-related information to the commissioning couple.
4. The clinics must be making the commissioning couple familiar with the rights of the child to be born out of the assisted technology. 
5. The clinics must ensure that assisted reproductive technology must be provided only to men and women who are above the legal age of marriage and below the age of fifty years.
6. Physical inspection by the National Board, National Registry and State Boards is to be mandatorily conducted in banks and clinics and the latter must cooperate in the same. 
7. Written consent of all the parties seeking assisted reproductive technology must be the prerequisite of every clinic conducting such technological reproduction. 
8. Human reproductive material, except in accordance with the provisions of this Act, must not be used by any clinics.

Duties of assisted reproductive technology clinics and banks to keep an accurate record

1. All clinics and banks must keep meticulous records of all donor oocytes, sperm, and embryos utilized or discarded, as well as the processes and techniques employed.
2. If a clinic or bank closes before the ten-year period is over, the records must be immediately transferred to the National Registry’s central database.
3. Records must be made accessible for review by the National Board, the National Registry, the State Board, or any other person authorized by the National Board to do so.

Duties of assisted reproductive technology clinics using human gametes and embryos

1. During any one treatment cycle, a woman shall not be treated with gametes or embryos derived from more than one man;
2. Clinics shall harvest oocytes in the manner specified by regulations laid down by the Act;
3. Embryos shall not be split and used for twinning to increase the number of available embryos;
4. A posthumous collection of gametes shall be done only if prior consent of the commissioning couple is available; 
5. In any method of in-vitro fertilization, the clinic should not use an ovum generated from a foetus.

Deterrence provided by Assisted Reproductive Technology (Regulation) Bill, 2020

It is to be noted that every offence committed under the Assisted Reproductive Technology (Regulation) Bill, 2020 shall be cognizable and bailable, according to Section 36 of the legislation. 

1. If sex-selective assisted reproductive technology is practiced by any means in any clinics or banks, the same shall be punished by imprisonment for a term of not less than five years but not more than ten years, or by a fine of not less than ten lakh rupees but not more than twenty-five lakh rupees, or with both.
2. Disowning of a child born through assisted reproductive technology, selling or importing of human embryo or gametes, exploiting the commissioning couple, etc, shall be punishable;

1. For the first contravention, with a fine of not less than five lakh rupees which may extend to ten lakh rupees;
2. For subsequent contraventions, imprisonment for a term of not less than eight years but may extend to twelve years and a fine of not less than ten lakh rupees which may extend to twenty lakh rupees.

Drawbacks of the Assisted Reproductive Technology (Regulation) Bill, 2020

A close study of the 2020 Bill reveals that the Bill specifically revolves around couples which consist of a man and a woman. Provisions for single men and the LGBTQ+ community stand clearly absent from the much-discussed Bill. Standing in the 21st century, the lawmakers must understand that the concept of ‘nurtures’ has expanded enough to cover not only females taking up the said role but even single men and individuals belonging from the LGBTQ+ community excelling in the role of care-givers. Unfortunately, the Bill failing to recognize the same has to carry the baggage of having a loophole. The four possible ways by which single men can have a child in India are: 

1. Hiring a surrogacy/gestational carrier;
2. By choosing a reputable egg donor agency;
3. Using embryo donation;
4. Adoption. 

But these methods are not protected by means of the Assisted Reproductive Technology (Regulation) Bill, 2020. Leave aside individuals belonging from the LGBTQ+ community who are not even perceived to be eligible for nurturing their own child by means of assisted reproductive technology. This backward mentality should be overcome as soon as possible.  

Conclusion 

The legislation would be benefiting patients, according to experts, by offering more uniform treatment methods and making vital information available to them. “ART clinics have sprung up all throughout India, many of them unregistered. Their methods and equipment are frequently dangerous. The ART law will improve the quality of service delivery and avoid malpractice in these facilities”, Dr. Souren Bhattacharya, consultant and center head at Birla Fertility & IVF, stated. Couples will be empowered by the new legislation, which would provide them with the necessary knowledge regarding treatment alternatives. In many ways, the new Bill aims to raise knowledge about IVF and reproductive treatments, allowing people to have a better understanding of their rights. Legislatures should consider amending the discussed Bill by adding provisions particularly focusing on single men and the LGBTQ+ community, taking into account their right to have a child by the use of assisted reproductive technology as well. 

References

1. https://prsindia.org/billtrack/the-assisted-reproductive-technology-regulation-bill-2020.
2. https://www.thehindu.com/news/national/lok-sabha-passes-bill-to-regulate-ivf-clinics/article37790488.ece.
3. https://www.civilsdaily.com/news/assisted-reproductive-technology-regulation-bill-2020-3/.
4. https://www.livelaw.in/news-updates/lok-sabha-passes-bill-to-regulate-assisted-reproductive-technology-186756.

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