What is Assisted Reproductive Technology? What are the provisions of the ART Act, 2021? How is it different from the surrogacy act? Know more here.
The Lok Sabha and Rajya Sabha passed The Assisted Reproductive Technology (Regulation) Bill, 2020 December 2021.
ART Act proposes the establishment of a national registry and registration authority for all clinics and medical professionals serving in the field.
Assisted reproductive technology (ART) is used to treat infertility.
What is Assisted Reproductive Technology?
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.
Assisted Reproductive Technology fertility treatments handle both a woman’s egg and a man’s sperm.
By definition, ART does not include treatments in which only sperm are handled or procedures in which a woman takes medicine only to stimulate egg production without the intention of having eggs retrieved.
It works by removing eggs from a woman’s body which are then mixed with sperm to make embryos. The embryos are then put back in the woman’s body.
Also read: Mitochondrial Donation Treatment
The Assisted Reproductive Technology (Regulation) [ART] Act, 2021
The act 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-fertilization (fertilizing an egg in the lab), and gestational surrogacy (the child is not biologically related to the surrogate mother).
ART services will be provided through:
- ART clinics, which offer ART related treatments and procedures, and
- ART banks, which store and supply gametes.
Regulation of ART clinics and banks:
The act provides that every ART clinic and the bank must be registered under ICMR’s National Registry of Banks and Clinics of India
The National Registry will be established under the act and will act as a central database with details of all ART clinics and banks in the country.
The State governments will appoint registration authorities for facilitating the registration process. The Clinics and banks will be registered only if they adhere to certain standards (specialized 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 canceled or suspended if the entity contravenes the provisions of the act.
Also read: Gene Editing – What is CRISPR-Cas9?
Conditions for gamete donation and supply:
- Screening of gamete donors, collection and storage of semen, and provision of oocyte donors 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 a married woman having at least one alive child of her own(minimum three years of age).
- The woman can donate oocytes only once in her life and not more than seven oocytes can be retrieved from her.
- A bank cannot supply the gamete of a single donor to more than one 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 act also requires checking for genetic diseases before embryo implantation.
Rights of a child born through ART:
- A child born through ART will be deemed to be a biological child of the couple (commission 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 act provides that the National and State Boards for Surrogacy constituted under the Surrogacy (Regulation) Act, 2021 will act as the National and State Board respectively for the regulation of ART services.
Key powers and functions of the National Board include:
- advising the central government on ART related policy matters
- reviewing and monitoring the implementation of the act
- formulating code of conduct and standards for ART clinics and banks,
- overseeing various bodies to be constituted under the act.
The State Boards will coordinate enforcement of the policies and guidelines for ART as per the recommendations, policies, and regulations of the National Board.
Also read: Genome India Project (GIP)
Offences and penalties:
- abandoning, or exploiting children born through ART
- selling, purchasing, trading, or importing human embryos or gametes,
- using intermediates to obtain donors
- exploiting commissioning couple, woman, or the gamete donor in any form
- 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 a fine between Rs 10 lakh and Rs 25 lakh, or both.
No court will take cognizance of offences under the act, except on a complaint made by the National or State Board or any officer authorized by the Boards.
Difference between Surrogacy Act and ART act
Relates to surrogacy, an infertility treatment, where a third person, a woman, is the surrogate mother.
Treatments can be availed by the commissioning couple themselves and it is not always necessary that a third person is involved
Surrogacy is allowed for only Indian married couples
ART procedures are open to married couples, live-in partners, single women, and also foreigners.
It prohibits the commissioning of surrogacy in India by foreigners or OCI or PIO cardholders, but NRIs holding Indian citizenship can avail of surrogacy.
Foreigners can visit India under medical tourism to avail ART services.
There will be a National Surrogacy Board that will be involved in policymaking, and act as a supervisory body, and State Boards that will act as executive bodies.
The ART act provides for a National Board, with the powers vested in a civil court under the Code of Civil Procedure.
About 1000 clinics are practicing surrogacy in India according to the health ministry.
ART practicing clinics are likely more than 40,000.
The need for ART act:
India is becoming a major center of the global fertility industry, with reproductive medical tourism increasing significantly.
Standardized Protocols: Many ART clinics have been running without regulation and it may affect the health of those who undertake the procedure. If there is no regulation, unethical practices will increase.
Protection of Women and Children: The oocyte (a cell in an ovary) donor needs to be supported by an insurance cover. Multiple embryo implantations need to be regulated and children born through ART need to be protected.
Concerns and criticisms:
The act allows for married heterosexual couples and a woman above the age of marriage to use ARTsand excludes single men, cohabiting heterosexual couples, and LGBTQ+ individuals and couples from accessing ARTs.
Both surrogacy and ART act will set up multiple bodies for registration which will result in duplication or worse, lack of regulation.
For example, a surrogacy clinic is not required to report surrogacy to the National Registry.
The act violates article 14 of India’s constitution and is also silent on the rights of children. (Article 14 states that equality before the law and equal protection of law to any person within India cannot be denied.)
The cost of the procedure should be monitored so that even the poor can avail the services.