Lok Sabha Passes Bill To Regulate Assisted Reproductive Technology

The Lok Sabha on Wednesday passed the Assisted Reproductive Technology (Regulation) Bill 2020 for prevention of misuse and for safe and ethical practice of assisted reproductive technology services. The bill has been passed with amendments.

The Bill, first tabled in the Lok Sabha on 14 September 2020, defines "assisted reproductive technology" to include 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.

Significantly, the proposed legislation was referred to the parliamentary standing committee in October 2020, for further examination. The standing committee tabled its report in Parliament on 19th March this year.

While tabling the Bill, Health Minister Mansukh Mandaviya said that the Centre has considered the suggestions made by the standing committee.

The need to bring the legislation was felt in face of the rising demand for ART services. "India has over the years become one of the major centres of this global fertility industry, with reproductive medical tourism becoming a significant activity...However, there is yet no standardisation of protocols and reporting is still very inadequate," the statement of objects annexed to the Bill stated.

The Bill contains provisions for the protection of rights of the donors, the commissioning couple, and the children born out of ART.

Regulation of ART clinics

The Bill provides for establishment of National Registry of Clinics and Banks, which will act as a central database for details of all the clinics and banks in the country.

The National Registry will grant registration to such clinics and banks that are in a position to provide such facilities and maintain such equipment and standards including specialized manpower, physical infrastructure and diagnostic facilities. The same will be valid for a period of five years and can be renewed for a further five years.

The registration may however be cancelled of the Registration Authority is satisfied that there has been a breach of the provisions of the Act or Rules framed thereunder.

National and State Boards

The Bill also provides for establishment of National and State Boards for Surrogacy for regulation of ART services.

The National Board shall advise the Central Government on policy matters relating to the assisted reproductive technology. It will also review and monitor the implementation of the Act, rules and regulations made thereunder and recommend to the Central Government, any suitable changes therein.

Conditions for donation of gametes

As per the Bill, the sourcing of gametes shall be done only by a registered ART bank. It may collect semen from males between 21-55 years of age (both inclusive) and oocytes from females between 23-55 years of age.

It further provides that an oocyte donor shall be an ever married woman having at least one live child of her own with a minimum age of 3 years. Further, the donation can be done only once in her life and not more than 7 oocyte shall be retrieved from the donor.

The ART services shall be applied to woman should be above the legal age of marriage (18 years) and below the age of 55 and a man should be above the legal age of marriage (21) and below the age of 55 years.

Significantly, the assisted reproductive technology services shall be available to a commissioning couple or a woman.

The Bill also provides for pre-implantation genetic testing to screen the human embryo for known, pre-existing, heritable or genetic diseases or for such other purposes as may be prescribed.

Rights of a child born through ART

Section 31 of the Bill provides that the child born through assisted reproductive technology shall be deemed to be a biological child of the commissioning couple and the said child shall be entitled to all the rights and privileges available to a natural child only from the commissioning couple under any law for the time being in force.

 A donor shall relinquish all parental rights over the child or children which may be born from his or her gamete.

Conditions for offering ART services

No ART clinic shall perform any treatment or procedure without the written consent of all parties seeking assisted reproductive technology. Further, the commissioning couple shall provide an insurance coverage in favour of the oocyte donor.

The clinics shall not offer to provide a couple or woman with a child of a pre-determined sex.

Counselling

The Bill provides that assisted reproductive technology clinics shall provide professional counselling to commissioning couple and woman about all the implications and chances of success of ART 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.

Offences & Penalties

Offences under the Bill include: (i) abandoning, or exploiting children born through ART, (ii) selling, purchasing, trading, or importing human embryos or gametes, (iii) using intermediates to obtain donors, (iv) exploiting commissioning couple, woman, or the gamete donor in any form, and (v) transferring the human embryo into a male or an animal.

These offences will be punishable with a fine between Rs. 5-10 lakh for the first contravention. For subsequent contraventions, these offences will be punishable with imprisonment for a term between 8-12 years, and a fine between Rs. 10-20 lakh.

Parliamentary Debate

"There are many people who are unable to have children and who find the benefit from ART. It is essential that this technology is available to all and is regulated and ensure that best medical practices are followed while this techno is made available," Congress MP from Tamil Nadu KP Chidambaram said.

However, he remarked that the Bill is regressive inasmuch as it excludes LGBTQ community, live-in couples and single men from access to ART. He thus said that the Bill is discriminatory, violative of Article 14 of the Constitution and in contravention of the Supreme Court's judgment in KS Puttasawamy v. Union of India.

The Government however clarified that as per Adoption Regulations 2017, single men cannot adopt a girl child. And since sex determination is not legal, it is not feasible for a single man to avail to ART. Further, it was stated that single woman can take advantage of ART to become a parent; so it extends to LGBTQ individuals.

Chidambaram further pointed out that single women are precluded from being gamete donors. "According to the Government, unless a woman fulfills the role of becoming a mother in an established union, she cannot become a donor," he said.

It was further highlighted that the instant Bill refers to the Surrogacy Bill, which is yet to become a law. "This Bill says there will be an oversight board which draws its powers from the Surrogacy Act...How are you going to establish the Board when you are drawing the power from an Act which is not there?"

The Health Minister clarified that as per recommendation of the parliamentary standing committee, both the Surrogacy Bill and ART Bill will be tabled before the Rajya Sabha together. He added that this Bill will be implemented only after the Surrogacy Bill is passed.

Chidambaram also stated that a child born through ART should be given the right to know who his father is, after he attains the age of 18 years, while balancing the identity of the donor.

The MP also stated that there should be a program for making ART available to those who do not have adequate monetary resources.

AITC MP Kakoli Ghosh pointed out that the National and State Boards proposed under the Bill shall be comprised of administrators who have no knowledge of the equipment and procedures of ART. 

Mandaviya clarified that a team of 10 medical experts will guide the Board.  

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