By Prachi Singal
Published On : August 18, 2021 16:55 IST
Introduction
Regulation of Assisted Reproductive Technologies (hereinafter referred as ‘ART’) has been in discussion for over fifteen years considering the significant growth and misuse of these services in India.
The Assisted Reproductive Technology (Regulation) Bill, 2020 (hereinafter referred as ‘the Bill’) was introduced in the Lok Sabha on September 14, 2021 with the aim to regulate and supervise ART banks and clinics, allow safe and ethical practice of ARTs and protect women and children from exploitation of these services.
This Bill was introduced to precede the Surrogacy (Regulation) Bill, 2019, which awaits consideration by the Rajya Sabha after review by two parliamentary committees.
What is Assisted Reproductive Technology?
Assisted Reproductive Technologies are used to treat infertility. It covers fertility treatments that handle both a woman’s egg and a man’s sperm. Generally, ART procedures involve surgically removing eggs from a woman’s ovaries, combining them with sperm in the laboratory, and returning them to the woman’s body or donating them to another woman.[i]
As per the definition provided in the Bill, assisted reproductive technology means “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.[ii]”
What is the need for the Bill?
As per the Statement of Objects and Reasons of the Bill, the ART has grown rapidly in the last few years and India has registered the highest growth in the ART centres and the number of ART cycles performed every year. ART including In Vitro Fertilization (IVF), has given a hope to many people suffering from infertility but introduced a plethora of legal, ethical and social issues.
Reproductive medical tourism has become a significant activity in India, as India emerges as one of the major centres of global fertility industry over the years. Clinics in India offer nearly all the ART services :
- Gamete donation,
- Intrauterine insemination (IUI),
- In-vitro fertilization (IVF),
- Intra cytoplasmic sperm injection (ICSI),
- Pre-implantation genetic testing (PGT) and
- Gestational surrogacy.
The reproductive segment of the Indian medical tourism market is valued at more than $450 million a year and was forecast by the ICMR to be a six billion dollar a year market in 2008. India’s fertility industry in is an integral part of the country’s growing medical tourism industry, which experienced 30% growth in 2000 and 15% growth between 2005 and 2010.[iii]No standardized protocols and lack of reporting is a huge cause of concern. Furthermore, there are only guidelines of ART, and no law still exist which makes exploitation of these technologies much easier.
What is the background of the Bill?
Time and again attempts have been made to regulate the field of ART including one of its most controversial products, surrogacy. In pursuance of the same, Indian Council of Medical Research drafted the National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India in 2005 as the first ever national guidelines for laying down standards of conduct for ART and surrogacy in India.
Subsequent Bills on ART i.e., the bills of 2008, 2010, 2014; all covered ARTs as well as surrogacy.However, in the light of the PILof Jayashree Wad Vs Union of India[iv], in 2016 the government banned foreign commissioning parents from accessing surrogacy and announced a separate Bill for surrogacy.
While examining the Surrogacy (Regulation) Bill, 2019, the Select Committee on the Surrogacy (Regulation) Bill, 2019 has recommended that it would be prudent to bring ART Bill before surrogacy Bill to establish a regulatory mechanism for ART clinics and address all the highly technical and medical aspects of ARTs without which surrogacy procedures cannot be conducted.
Consequently, the ART (Regulation) Bill, 2020 was introduced on September 14, 2020 in Lok Sabha by Union Health Minister Harsh Vardhan. It was referred to the Department-related Parliamentary Standing Committee on Health and Family Welfare, Rajya Sabha on October 3rd, 2020 by Chairman, Rajya Sabha in consultation with the Speaker, Lok Sabha for examination and Report, which submitted its 129th report on the ART Bill, 2020 on 19 March 2021.
What are the objectives of the Bill?
The Bill aims to provide the following:
- To regulate the ART services and protect the affected women and children from exploitation.
- To support the oocyte donor by an insurance cover and protection from multiple embryo implantation.
- To provide rights to children born through assisted reproductive technology equivalent to rights provided to biological children.
- To provide regulation for cryopreservation of sperms, oocytes and embryos by the ART banks.
- To make Pre-Implantation Genetic Testing mandatory for the benefit of the child born through assisted reproductive technology.
- To ensure proper registration of ART clinics and banks by establishing the National Board, the State Boards, the National Registry and the State Registration Authorities
- To regulate and supervise of ART clinics and banks, for prevention of misuse and for safe and ethical practice of ART services.[v]
What are the salient features of the Bill?
The salient features of the Bill are:
- The ART services shall be available to a woman above the legal age of marriage and below the age of 50 years and a man above the legal age of marriage and below the age of 55 years
- An oocyte donor shall be an ever-married woman having at least 1 live child of her own with a minimum age of 3 years and to donate oocytes only once in her life and not more than 7 oocyte shall be retrieved from the oocyte donor
- Defines important terms like “assisted reproductive technology”, “assisted reproductive technology clinic”, “commissioning couple”, “Woman”, etc.
- The Bill ensures that ART clinics shall provide professional counselling to commissioning couple and woman about all the implications and chances of success of assisted reproductive technology procedures in the clinic.
They shall also inform the advantages, disadvantages and cost of the procedures, their medical side effects, risks including the risk of multiple pregnancy and any such other matter as may help the commissioning couple to arrive at an informed decision that would most likely be the best for the commissioning couple and woman
- Establishing National and State Board
The Bill provides for setting up of the National Board and the State Board which shall be the same Board as proposed in the Surrogacy Bill.
The National Board is to lay down code of conduct to be followed by those working at clinics, and set the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert human resources to be employed by these clinics and banks. It also oversees the performance of various bodies constituted under this Bill and take appropriate steps to ensure their effective performance[vi].
TheState Boards have the duty to co-ordinate the enforcement and implementation of the policies and guidelines and follow the policies and plans laid by the National Board for clinics and banks in the State.[vii]
- National registry and registration authority
The Bill provides for setting up of the national registry that would be the central database in the country through which the details of all the clinics and banks of the country including nature and types of services provided by them, outcome of the services and other relevant information shall be obtained on regular basis.
- Penalties and punishments
The Bill lays down various offences which includepracticing sex selection, sale of human embryos or gametes, running agencies/rackets/organizations for such unlawful practices and abandoning, disowning or exploitation of children born through ART.
The Bill provides that those involved in trafficking and sale of embryos will be fined not less than 5 lakh rupees but may extend to Rs 10 lakh at first instance and in second instance the person could be imprisoned for not less than 8 years but may extend to 12 years with a fine not less than 10 lakh rupees but may extend to 20 lakhs.
It also provides that those involved in sex selective assisted reproductive technology shall be punishable with imprisonment for a term which shall not be less than 5 years but may extend to 10 years or with fine which shall not be less than 10 lakh rupees but may extend to 25 lakh rupees or with both
What are some of the setbacks with the Bill?
This Bill faces various gaps and omissions which need to be addressed in order for it achieve what it aims to. Some these concerns have been discussed here:
- Equal Accessibility
This Bill denies equal access. It allows access of ART services only to a married heterosexual couple and a woman above the legal age of marriage. It excludes from its ambit single men, cohabiting heterosexual couples and LGBTQI individuals and couples.
The rationale behind the provision is that even though the Supreme Court has decriminalized same sex relationship, it did not introduce any special provisions or grant any additional rights to same sex couples. The same applies for people who are in live in relationships. The committee in its 129th Report also supports this view and states:
“Given Indian family structure and social milieu and norms, it will not be very easy to accept a child whose parents are together but not legally married. The Committee feels that keeping the best interest of that child born through ART services and other parentage issues in case of their separation, it would not be appropriate to allow live-in couples and same sex couples to avail the facility of ART”.
As per this view if marriage is of the essence, then why same sex married couples are denied ART services? Such a provision is huge setback from the jurisprudence laid down in Justice K.S. Puttaswamy Vs Union of India[viii].
- Lack of proper counselling provisions
The Bill does not provide for counselling of oocyte donors unlike commissioning couple. Oocyte retrieval is potentially harmful to the woman’s health, a fact that the Bill itself recognises. Inspite of that the Bill only talks about written informed consent of the donor and fails to provide any counselling about the risks, harms and consequences of oocyte donation to donors.
- Poor Drafting
Bill prohibits the sale, transfer, or use of gametes and embryos and same is poorly worded. It is a source of confusion for foreign and domestic parents relying on donated gametes.
- Multiplicity of Bodies
Both Bills set up multiple bodies for registration which will result in duplication or worse, lack of regulation.
Conclusion
These were some of the problems that the Bill face. There are many concerns that Bill bears and require thorough reviewal. This Bill has been long awaited and currently fails to properly address many legal, ethical, medical and social issues related the use of ARTs. Regulation of ART is need of the hour and to ensure so an opportunity for meaningful and widespread public consultation on the Bill must be provided before it affects millions.
References
[i] “Assisted Reproductive Technology (ART)”, Centers for Disease Control and Prevention, (last visited on Aug 14, 2021)
[ii] Assisted Reproductive Technology (Regulation) Act, 2020 (Bill No. 97 of 2020), cl. 2(1)(c)
[iii] Department-Related Parliamentary Standing Committee On Health and Family Welfare, “129th on The Assisted Reproductive Technology (Regulation) Bill, 2020” (March,2021)
[iv]Jayashree Wad Vs Union of India (WP [C] No 95/2015)
[v]Supra note ii, Statement of Objects and Reasons
[vi]Supra note ii, cl.5
[vii]Supra note ii, cl.8
[viii]Justice K.S. Puttaswamy Vs Union of India, (2017) 10 SCC 1