Brief of Assisted Reproductive Technology (Regulation) Act, 2020

for SANSAD Panel Discussion

 On an estimate, 10-14% of the population of India is affected due to

infertility and the failure to conceive naturally leads to the resort
of Assistive Reproductive Technology (ART) for giving birth.

 Fundamentally, motherhood and childhood have been

contemplated as matters of substantial public interest and have
been emphasized in the “Directive Principle of State Policy” (DPSP)
and “International Covenant on Economic, Social and Cultural Rights”

 The Indian Parliament recently passed two landmark acts – the Assisted
Reproductive Technology (Regulation) Bill and the Surrogacy
(Regulation) Bill – both of which will have a strong impact on Indian
women’s reproductive rights and health.

Assisted Reproductive Technology (ART)

 It is used to treat infertility.

 It includes fertility treatments that handle both a woman's egg and a
man's sperm.
 In vitro fertilization (IVF) is the most common and effective type of ART.
 ART procedures sometimes use donor eggs, donor sperm, or previously
frozen embryos.
Aims & Objectives of Act:

 Seeks to set minimum standards and codes of conduct for fertility clinics
and egg or sperm banks
 Formulates standard operating procedures to ensure “uniform costs”
and “global quality standards” across India
 Provisions for safe and ethical practice of assisted reproductive
technology services in the country
 Ensures confidentiality of intending couples and protect the rights of
the child born through ART
 Endeavors to put an end to unethical or exploitative ART practices

Key Provisions of the Act:

 Eligible Parties for availing ART services

 Infertile married couple;
 Any woman above 21 years (unmarried, divorced, widow)
 Silent on single men, same sex couples, live-in couples, LGBTQIA

 Creation of the National Assisted Reproductive Technology and

Surrogacy Board

National Assisted Reproductive Technology and Surrogacy Board under

Section 15 of the Surrogacy Act. The Board will advise the Central
Government, review and monitor the implementation of the Act,
lay down the code of conduct for employees of clinics and banks,
set minimum standards for infrastructure and other aspects of
 equipment and manpower and clinics and banks, oversee the
performance of bodies created under the Act, and supervise the
functioning of the National Registry.

 National ART and Surrogacy Registry

The Registry is meant to act as a central database for all facilities

providing ART services in India, with state governments appointing
relevant authorities there to facilitate the registration process.
Registrations must be renewed every five years and may be cancelled or
suspended if an entity contravenes the provisions of the Bill.

 Setting up of Appropriate Authorities

Central and State governments will set up Appropriate Authorities

that will comprise of:

 Chairperson, who will be an officer above the rank of joint

secretary in the Health Department;
 Vice-chairperson, who will be above the rank of joint director;
 An eminent woman representing a women’s rganization;
 An officer of the Law Department; and
 An eminent registered medical practitioner

The authority will grant, suspend, or cancel the registration of ART

centres; enforce standards and supervise the implementation of the law;
investigate complaints regarding the breach of provisions, take legal
 action against the misuse of ART, initiate independent investigations;
and recommend to the National and State Boards modifications to the
regulation with the evolution of technology and social conditions.

 Mandatory Registration of ART Clinics :

Every ART clinic and bank must be registered under the National
Registry of Banks and Clinics of India. The Registry is meant to act as a
central database for all facilities providing ART services in India, with
state governments appointing relevant authorities in their respective
states to facilitate the registration process. This will ensure the ART
Clinics are brought under review and no malpractices are used by
them.

 Prescribes the conditions of donation, supply, and services

ART banks are the only bodies authorized to screen gamete donors,
collect and store semen, and provide oocyte donors. Semen can only be
obtained from males between the ages of 21 and 55, and oocytes may
only be obtained from females between the ages of 23 and 35. A woman
can only donate oocytes once in her life, and not more than seven
oocytes can be retrieved from her. Furthermore, a bank cannot supply
the gamete of a single donor to more than one commissioning couple. A
gamete may not be stored for a period longer than ten years, after which
time it may be destroyed or donated for research with the permission of
the commissioning couple or individual.
 Written Informed Consent of Parties and Donor (Section-22)

ART services can only be provided after obtaining the written informed
consent of the parties seeking the ART services, as well as the donor.
The commissioning couple will be required to provide insurance
coverage from an insurance company to the oocyte donor, to cover
specified losses, damage, complications, or the death of the donor
during the process. 

Any of the commissioning couple may withdraw his or her consent,

any time before the human embryos or the gametes are transferred
to the concerned woman's uterus.

 12 months of Insurance Coverage for Donor (Section-22)

Insurance coverage of such amount as may be prescribed for a period of

twelve months in favor of the oocyte donor by the commissioning
couple or woman from an insurance company or an agent recognized by
the IRDA

 Pre-Genetic Implantation Testing Mandatory

The test allows doctors to test embryos for any possible abnormal
chromosomes before they are transferred to the uterus. This is to avoid
 any genetic diseases in the population born through these technologies.
This ensures Safety and Health of Child

Contravention is punishable under Section- 33(2): Upto 3 years

imprisonment and penalty 5-10 lakh

 Rights of the child are protected

A child born using ART is deemed the biological child of the

commissioning couple or individual and is entitled to the same rights
and privileges as a natural child. The donor must relinquish all parental
rights over children born from his or her gamete.

 Act resolves the following legal issues:

 Adultery as a ground of Dissolution of marriage- In English

cases, artificial insemination without the prior consent of the husband
amounted to adultery and has held as a reasonable ground for divorce

 Issues of Legitimacy and Inheritance of property- A child born

using ART is deemed the biological child of the commissioning couple
or individual and is entitled to the same rights and privileges as a
natural child. The donor must relinquish all parental rights over
children born from his or her gamete. Legitimacy embodied under
Section- 112, Evidence Act will be attracted for the child born out of
ART. This will ensure that the Child’s Right to dignity and life is
 ensured and all personal rights of succession, maintenance are
provided to the child from the father.

 Issues as to Privacy of the Donor which is now recognized as a

Constitutional Right after J. Puttaswamy Judgment

 Penal provisions:
 Sex selection
It also proposes stringent punishment for those practicing sex
selection and sale of human embryos or gametes.
Enhanced punishments for repeated offenders

 Advertising or offering sex-selective ART

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.

 Trafficking and sale of embryos:

The bill also has a provision that those involved in trafficking and
sale of embryos will be fined Rs 10 lakh in the first instance and in
the second instance, the person can be imprisoned for up to 12
years.
  Data and privacy of client data

Provides robust protections for client data. Clinics and banks are
supposed to provide all information pertaining to client enrolment,
procedures, complications and outcomes to the national registry
through a system of online submission.

Contravention is punishable under Section- 33(2): Upto 3 years

imprisonment and penalty 5-10 lakh

Loopholes:

 Doesn’t cover Single men, cohabiting heterosexual couples, same sex

couples and LGBTQIA persons

(Parliamentary Select Committee’s Comment: Keeping the best

interest of that child born through ART services and parentage
issues involved in case of separation, these parties have been
kept out of purview of the Act)

 Inconsistent with Transgender Persons (Protection of Rights) Act, 2019

and Juvenile Justice Act, 2015 (under which single and divorced people
can adopt) 
Conclusion:

While assisted reproductive technology (ART), including in vitro fertilization

has given hope to millions of couples suffering from infertility, it has also
introduced countless ethical, legal, and social challenges. Furthermore, India
today is a hub of the global fertility industry with medical tourists flocking to
the country for a variety of services, hence, the present act is perfectly timed.
State has a responsibility to ensure that the advances achieved through
ART are implemented in a socially responsible manner. It promotes
reproductive autonomy and protects the rights of service users through clear
standards and protocols for treatment and care.