Assisted Reproductive Technology Regulations (ART), 2023

Disclaimer: Copyright infringement not intended.

Context

Earlier this year the Health Ministry notified the Assisted Reproductive Technology Regulations (ART), 2023, which are aimed at providing donors and patients with better medical care and security.
These Amendment Rules were notified on 24th February, 2023 and come into immediate effect.

Background

ART means all techniques that attempt to facilitate a pregnancy by handling the sperm or the oocyte outside the human body and transferring the gamete or the embryo into the reproductive tract of a woman while an ART clinic is defined as any facility carrying out the ART-related procedures.
Noting that ART clinics in India offer ART services ranging from gamete donation, intrauterine insemination, in-vitro fertilisation, intra-cytoplasmic sperm injection to pre-implantation genetic diagnostic and gestational surrogacy, etc., it adds that despite “so much activity in India, there is yet no standardisation of protocols and reporting is still very inadequate”.
The ART Act came as a ray of hope for lakhs of infertile couples, but also gave rise to legal, ethical and social tussles. Through the Act, the national board, state boards, national registry and state registration authorities will regulate and supervise such clinics and banks.

Assisted Reproductive Technology (Regulation) Bill, 2021

Background to the Bill

Assisted reproductive technologies (ART) refer to a range of fertility treatments aimed at aiding reproduction for couples suffering from infertility or to persons who may wish to have a child through artificial methods. These arrangements include in-vitro fertilisation (fertilising an egg in the lab), gamete donation (sperm or egg), and gestational surrogacy (where the child is not biologically related to the surrogate mother). As per private estimates shared with the Standing Committee on Health and Family Welfare (2017), around 2.8 crore couples in the reproductive age group in India are infertile and about 1% of these seek infertility evaluation. Of the people seeking remedy for infertility, 20-25% undergo in vitro fertilisation treatment and of that, 1% may require surrogacy.
In 2005, the Indian Council of Medical Research (ICMR) issued guidelines to regulate clinics providing ART procedures (including surrogacy procedures). The guidelines provide for registration of clinics offering ART services, permit single women and couples to access ART services, and allow ART banks to compensate donors. These guidelines also specify conditions for when surrogacy may be opted, and the compensation for surrogates.
In July 2019, the government introduced the Surrogacy (Regulation) Bill. The Bill provides for the registration of surrogacy clinics, defines the eligibility criteria of commissioning couples and surrogates, and provides for the establishment of boards to advise the government on surrogacy policies. The Bill was passed by Lok Sabha in August 2019. In Rajya Sabha, the Bill was referred to a Select Committee of the House. While examining the Bill, the Committee recommended introducing a comprehensive legislation to first regulate clinics and banks providing various fertility services, i.e., ART and surrogacy services.
The Assisted Reproductive Technology (Regulation) Bill, 2020 was introduced in Lok Sabha in September 2021 and was referred to the Standing Committee on Health and Family Welfare in October 2020. On December 1, 2021, Lok Sabha passed the ART Bill, with certain amendments. In this note, we discuss the key provisions of the ART Bill, 2021 (as passed by Lok Sabha), and the key issues which still remain to be considered.

Key Features of the Bill

Provision of ART services: 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. These include gamete donation (of sperm or egg), in vitro fertilization, and gestational surrogacy. ART services will be provided through: (i) ART clinics, which offer ART related treatments and procedures, and (ii) ART banks, which collect, screen and store gametes.
Registration of ART clinics and banks: Every ART clinic and bank must be registered under the National Assisted Reproductive Technology and Surrogacy Registry. A National Registry will be established under the Bill, which will act as a central database with details of all ART clinics and banks in the country. Clinics and banks will be registered only if they adhere to certain standards (such as specialised manpower, physical infrastructure, and diagnostic facilities). The registration will be valid for five years and may be renewed. The central and state governments will appoint appropriate authorities to support registration related services such as maintenance of details of registration of assisted reproductive technology clinics and banks, cancellation and renewal of registration.
Boards: The Bill provides that the National and State Boards constituted under the Surrogacy (Regulation) Bill, 2019 will also act as the National and State Boards for the regulation of ART services. Key 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 a code of conduct and standards for ART clinics and banks, and (iv) overseeing bodies constituted under the Bill. The State Boards will coordinate enforcement of policies and guidelines for ART as per the directions of the National Board.
Eligibility criteria for commissioning parties: ART services may be commissioned by married couples or women where: (i) the woman is between 21 and 50 years of age, and (ii) the man is between 21 and 55 years. Married couples must also be infertile, i.e. unable to conceive after one year of unprotected coitus or suffer from any other proven medical condition which prevents conception.
Eligibility criteria for donors A bank may obtain semen from males between 21 and 55 years of age, and eggs from females between 23 and 35 years of age. The woman may donate eggs only once in her life and not more than seven eggs may be retrieved from her. A bank must not supply gamete of a single donor to more than one commissioning party (i.e. couples or single women seeking services).
Conditions for offering services: ART procedures must be conducted only with the written consent of the commissioning parties and the donor. The commissioning party will be required to provide insurance coverage in favour of the egg donor (for any loss, damage, or death). Clinics are required to check for genetic diseases before implantation and are prohibited from providing any sex-selective services (e.g. sex determination).
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.
Duties of ART Clinics and Banks: ART clinics and bank must share information related to: (i) enrolment of the commissioning parties and donors, (ii) procedures being undertaken, and (iii) outcome of the procedure, with the National Registry. Further, they must maintain records of all donations for at least 10 years, after which the records must be transferred to the National Registry. While using human gametes and embryos, ART clinics and banks must: (i) harvest eggs in the manner specified by regulations, and (ii) place such number of eggs or embryos in the uterus of the woman as may be specified by regulations.
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, and (iii) exploiting the commissioning couple, woman, or the gamete donor in any form. 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 between three and eight years, and a fine between 10 and 20 lakh rupees. A court will take cognisance of an offence only on a complaint by the National or State Board.

Comparison of the key provisions of the Surrogacy Bill, 2019 and the ART Bill, 2021

	Surrogacy (Regulation) Bill, 2019 (as passed by Lok Sabha)	ART Bill, 2021 (as passed by Lok Sabha)
Infertility	Infertility is defined as inability to conceive after five years of unprotected sex. Married couples must prove infertility to access surrogacy.	Infertility is defined as the inability to conceive after one year of unprotected sex. Married couples must be infertile to access ART.
Regulation	Framework: The central and the state governments will constitute National and State Surrogacy Boards. The functions of the National Board include advising the central government on policy matters and supervising the functioning of State Boards. Registration: Appropriate Authorities at the national and state level will regulate registration of clinics. Registration must be granted within 90 days and will be valid for a period of three years.	Framework: National and State Surrogacy Boards under the 2019 Surrogacy Bill will act as the Boards under the ART Bill. These will be called National Assisted Reproductive Technology Surrogacy Board and State Assisted Reproductive Technology Surrogacy Board. Registration: The central government will appoint Appropriate Authorities (called the Appropriate Assisted Reproductive Technology and Surrogacy Authority) which will regulate the registration of clinics for both surrogacy and ART services (includes banks). The Authorities will be constituted at national and state level. The Appropriate Authority must report all registrations to the State Board. Registration will be granted only after the State Board inspects the premises. Registration must be granted within 30 days (or will be deemed granted) and will be valid for five years.
Eligibility to commission	Indian couples: (i) where the woman is 23-50 years old and the man is 26-55 years old, (ii) married for at least five years, and (iii) with no surviving biological, adopted or surrogate children.	Commissioning couples woman is between 21-50 years and the man is between 21-55 years. Single women may avail ART services. Foreigners are not prohibited from availing ART services.
Offences	Punishes acts (e.g. selling gametes) with imprisonment of up to 10 years and fine of up to Rs 10 lakh. Any other violation by a surrogacy practitioner or clinic owner attracts imprisonment of up to 5 years with fine, with higher penalties for subsequent offences. Imprisonment up to 3 years with fine, if no penalty set out. Any person may directly file a complaint (with notice of at least 15 days to the appropriate authority). Offences are non-bailable.	Prohibits similar acts with fine of Rs 5-10 lakhs. Subsequent violations attract imprisonment of 3-8 years, along with fine of Rs 10-20 lakh. Similar punishment (as above) applies to those offences where no penalty is specified. Complaint to court may only be made by the National Board, the State Board or its authorised officer. Offences are bailable.
Seizure	Only the registration authority may enter premises, search clinics and seize documents.	The National/State Board and the National Registry have the powers to search premises and seize documents.
Storage	25 years or such other prescribed period.	At least 10 years; then records transferred to the Registry.

International Comparison of ART laws

Country	India	United Kingdom	South Africa	Canada	Australia (Victoria)
Payment to the donor	.Medical expenses and insurance coverage.	.Reasonable medical expenses.	.Reasonable expenses	.Reimbursements include for travel and counselling.	.Reasonable expenses
Age of commissioning party	.Male between 21-55 .Female between 21-50	.Not specified	.At least 18 years of age	§ Not specified.	.Not specified.
Marriage needed to commission ART	.Marriage required, but single women allowed.	.No requirement.	.No requirement.	.No requirement.	.No requirement.
Medical reason to commission ART	.Couples must prove infertility.	.Not specified.	.Not specified.	.Not specified.	.If woman cannot conceive/carry child to term without treatment, or the woman/her partner risks transmitting a genetic abnormality.
Age of donor	.Male between 21-55 .Female between 23-35, with at least one child (minimum 3 years old).	.Male between 18-45 years. .Female between 18-35 years (except in certain cases)	.At least 18 years old. .Exception made in case of a medical indication.	.At least 18 years old .Exception made for preservation of own gamete.	.At least 18 years old .Exception made if there is a risk of the child becoming infertile before adulthood.
Restrictions on donors	.Only one donation for an egg donor (with up to 7 eggs retrieved).	.Not more than 10 families per donor.	.Not more than six births using donor gametes.	.Not specified.	.Donated gametes cannot be used to produce more than 10 families.

Assisted Reproductive Technology Regulations, 2023

Key Points

Section 24of Assisted Reproductive Technology (Regulation) Act, 2021 focuses on Duties of assisted reproductive technology clinics using human gametes and embryos.

1.Further, Section 24(a)of the Act says that the clinics will retrieve oocytes in such manner as may be specified by regulations. These Regulations lays down the manner of retrieving the oocytes:

- The clinics will retrieve oocytes from the donor after obtaining consent from the doctor.
- Not more than 7 oocytes should be retrieved from the donor during one cycle, provided that all formed follicles are also retrieved.
It is the duty of the clinics to ensure the controlled ovarian stimulation of woman in order to prevent ovarian hyperstimulation.

2.Section 24 (b)of the Act says that not more than three oocytes or embryos may be placed in the uterus of a woman during the treatment cycle in such manner as may be specified by regulations. This Regulation further lays down the manner of placing the embryos in the uterus of a woman:

- Gynecologists will transfer 1-2 embryos in the uterus of a woman during a treatment cycle.
- Exception where 3 embryos can be transferred:advanced maternal age, recurrent miscarriages and recurrent implantation failure

Need for ART regulation in India

Minimum standards and codes: Act seek to set minimum standards and codes of conduct for fertility clinics and egg or sperm banks
Standard operating procedures: There is a need to formulate standard operating procedures to ensure “uniform costs” and “global quality standards” across India
Monitoring body: The committee also noted that a monitoring body should be set up to prevent the “commercialisation” of ART services by private players
To stop unethical or exploitative practices: The need of the hour is to stop unethical or exploitative practices

How the ART Act will help patients

Helps infertile couple to obtain fertility treatment in ethical and regulated manner.
Helps couple to get appropriate legal action against the misuse of assisted reproductive technology.
Helps couple to get action after investigation of complaints received by appropriate authority against the ART clinic or bank.
Couples with HIV, Hepatitis B & C positive status can also avail fertility treatment as there is provision of separate storage of these positive patient’s gametes or embryos in ART clinics.
Helps couple having cancer to avail facility of cryopreservation of oocytes, sperms and embryos for future fertility.
Helps and provides facility of cryopreservation of gametes to prepubertal and unmarried males and females before undergoing cancer therapy for future fertility.

PRACTICE QUESTION

Q. Consider the following statements with respect to Assisted Reproductive Technology Regulations (ART):

1.A bank may obtain semen from males between 21 and 55 years of age, and eggs from females between 23 and 35 years of age.

2.The woman may donate eggs only once in her life and not more than ten eggs may be retrieved from her.

3.A bank must not supply gamete of a single donor to more than one commissioning party (i.e. couples or single women seeking services).

Which of the above statements is/are correct?

(a) 1 and 2 only

(b) 1and 3 only

(d) All of the above.

Correct Answer: (b) 1and 3 only

https://www.thehindu.com/news/national/brought-in-to-protect-donors-and-prospective-parents-new-art-provisions-push-up-cost-and-challenges-in-assisted-conception/article67001330.ece