Assisted Reproductive Technology(ART) Regulation Bill, 2020

Context : Union Health Minister introduced the Assisted Reproductive Technology (Regulation) Bill, 2020 (Bill) in the Lok Sabha.

What is ART?

  • Assisted reproductive technology (ART) is used to treat infertility. It includes fertility treatments that handle both a woman’s egg and a man’s sperm. 
  • It works by removing eggs from a woman’s body. The eggs are then mixed with sperm to make embryos.
  • In Vitro fertilization (IVF) is the most common and effective type of ART.

Aim of the Bill :

  • Its aim is to regulate ART banks and clinics, allow safe and ethical practice of ARTs and protect women and children from exploitation.
  • The Bill was introduced to supplement the Surrogacy (Regulation) Bill, 2019 (SRB), which awaits consideration by the Rajya Sabha after review by two parliamentary committees.

Features of the bill :

  • The Assisted Reproductive Technology (Regulation) Bill, 2020 was introduced in Lok Sabha on September 14, 2020.  The Bill seeks to provide for the regulation of Assisted Reproductive Technology services in the country. 
  • Assisted Reproductive Technology (ART): The Bill defines ART to include all techniques that seek to obtain a pregnancy by handling the sperm or the oocyte (immature egg cell) outside the human body and transferring the gamete or the embryo into the reproductive system of a woman.  Examples of ART services include gamete (sperm or oocyte) donation, in-vitro-fertilisation (fertilising an egg in the lab), and gestational surrogacy (the child is not biologically related to surrogate mother).  ART services will be provided through: (i) ART clinics, which offer ART related treatments and procedures, and (ii) ART banks, which store and supply gametes.
  •  Regulation of ART clinics and banks: The Bill provides that every ART clinic and bank must be registered under the National Registry of Banks and Clinics of India.  The National Registry will be established under the Bill and will act as a central database with details of all ART clinics and banks in the country.  State governments will appoint registration authorities for facilitating the registration process.  Clinics and banks will be registered only if they adhere to certain standards (specialised manpower, physical infrastructure, and diagnostic facilities).  The registration will be valid for five years and can be renewed for a further five years.  Registration may be cancelled or suspended if the entity contravenes the provisions of the Bill. 
  •  Conditions for gamete donation and supply: Screening of gamete donors, collection and storage of semen, and provision of oocyte donor can only be done by a registered ART bank.  A bank can obtain semen from males between 21 and 55 years of age, and oocytes from females between 23 and 35 years of age.  An oocyte donor should be an ever-married woman having at least one alive child of her own (minimum three years of age).  The woman can donate oocyte only once in her life and not more than seven oocytes can be retrieved from her.  A bank cannot supply gamete of a single donor to more than one commissioning couple (couple seeking services).
  •  Conditions for offering ART services: ART procedures can only be carried out with the written informed consent of both the party seeking ART services as well as the donor.  The party seeking ART services will be required to provide insurance coverage in the favour of the oocyte donor (for any loss, damage, or death of the donor).  A clinic is prohibited from offering to provide a child of pre-determined sex.  The Bill also requires checking for genetic diseases before the embryo implantation.
  •  Rights of a child born through ART:  A child born through ART will be deemed to be a biological child of the commissioning couple and will be entitled to the rights and privileges available to a natural child of the commissioning couple.  A donor will not have any parental rights over the child.
  •  National and State Boards: The Bill provides that the National and State Boards for Surrogacy constituted under the Surrogacy (Regulation) Bill, 2019 will act as the National and State Board respectively for the regulation of ART services.  Key powers and functions of the National Board include: (i) advising the central government on ART related policy matters, (ii) reviewing and monitoring the implementation of the Bill, (iii) formulating code of conduct and standards for ART clinics and banks, and (iv) overseeing various bodies to be constituted under the Bill.  The State Boards will coordinate enforcement of the policies and guidelines for ART as per the recommendations, policies, and regulations of the National Board.
  • Offences and 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 five and ten lakh rupees for the first contravention.  For subsequent contraventions, these offences will be punishable with imprisonment for a term between eight and 12 years, and a fine between 10 and 20 lakh rupees. 
  •  Any clinic or bank advertising or offering sex-selective ART will be punishable with imprisonment between five and ten years, or fine between Rs 10 lakh and Rs 25 lakh, or both. 
  •  No court will take cognisance of offences under the Bill, except on a complaint made by the National or State Board or any officer authorised by the Boards. 

Concerns with the Bill

Issue of Exclusion :

  • .The Bill allows for a married heterosexual couple and a woman above the age of marriage to use ARTs.
  • It excludes single men, cohabiting heterosexual couples and LGBTQI individuals and couples from accessing ARTs.
  • This violates Article 14 of the Constitution and the right to privacy jurisprudence of Puttaswamy, where the Supreme Court held that “ the liberty of procreation, the choice of a family life” concerned all individuals irrespective of their social status and were aspects of privacy.
  • In Navtej Johar case, Justice Chandrachud exhorted the state to take positive steps for equal protection for same-sex couples.
  • Unlike the SRB, there is no prohibition on foreign citizens accessing ARTs.
  • Foreigners can access ART but not Indian citizens in loving relationships.
  • This fails to reflect the true spirit of the Constitution.

Consent

  • The ART Bill does little to protect the egg donor.
  • Harvesting of eggs is an invasive process which, if performed incorrectly, can result in death.
  • The Bill requires an egg donor’s written consent but does not provide for her counselling or the ability to withdraw her consent before or during the procedure.
  • She receives no compensation or reimbursement of expenses for loss of salary, time and effort.
  • Failing to pay for bodily services constitutes unfree labour, which is prohibited by Article 23 of the Constitution.
  • The commissioning parties only need to obtain an insurance policy in her name for medical complications or death; no amount or duration is specified.
  • The egg donor’s interests are subordinated in a Bill proposed in her name.
  • The Bill restricts egg donation to a married woman with a child (at least three years old).

3)Congenital Defects :

  • The Bill requires pre-implantation genetic testing.
  • If the embryo suffers from “pre-existing, heritable, life-threatening or genetic diseases”, it can be donated for research with the commissioning parties’ permission.
  • These disorders need specification or the Bill risks promoting an impermissible programme of eugenics.

4) Coordination with surrogacy bill :

  • There is considerable overlap between ART and SRB sectors. Yet the Bills do not work in tandem.
  • Core ART processes are left undefined; several of these are defined in the SRB.
  • Definitions of commissioning “couple”, “infertility”, “ART clinics” and “banks” need to be synchronised between the Bills.
  • A single woman cannot commission surrogacy but can access ART.
  • The Bill designates surrogacy boards under the SRB to function as advisory bodies for ART, which is desirable.
  • However, both Bills set up multiple bodies for registration which will result in duplication or lack of regulation (e.g. surrogacy clinic is not required to report surrogacy to National Registry).
  • Also, the same offending behaviours under both Bills are punished differently + punishments under the SRB are greater.
  • Offences under the Bill are bailable but not under the SRB.
  • Finally, records have to be maintained for 10 years under the Bill but for 25 years under the SRB.
  • The same actions taken by a surrogacy clinic and ART clinic  attract varied regulation.

Other governance related issues :

  • Children born from ART do not have the right to know their parentage, which is crucial to their best interests and protected under previous drafts.
  • There is no distinction between ART banks and ART clinics, given that gamete donation is not compensated, economically viability of ART Banks raises a question.
  • In previous drafts, gametes could not be gifted between known friends and relatives if this is not changed, gamete shortage is likely.
  •  The Bill’s prohibition on the sale, transfer, or use of gametes and embryos is poorly worded and will confuse foreign and domestic parents relying on donated gametes.
  • Unusually, the Bill requires all bodies to be bound by the directions of central and state governments in the national interest, friendly relations with foreign states, public order, decency or morality — being broadly phrased, it undermines their independence.

Way ahead :

  • The Bill to maintain a grievance cell but clinics must instead have ethics committees.
  • Mandated counselling services should also be independent of the clinic.
  • The poor enforcement of the PCPNDT Act, 1994, demonstrates that enhanced punishments do not secure compliance — lawyers and judges also lack medical expertise.
  • Patients already sue fertility clinics in consumer redressal fora, which is preferable to criminal courts.

Conclusion

The Bill raises several constitutional, medico-legal, ethical and regulatory concerns, affecting millions and must be thoroughly reviewed before passage