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Assisted Reproductive Technology (Regulation) Bill, 2021

Published: 6th Dec, 2021


Recently, Lok Sabha passed the Birth Control Bill, 2021 which aims to regulate and assist reproductive technology clinics and banks, prevent the misuse of technology and promote ethical services.


Key-Highlights of the ART (Regulation) Bill, 2021

  • Definition of ART: Under the Bill, ART will include all methods that attempt to detect pregnancy by carrying sperm or oocyte (an immature egg) outside the human body, and transmitting the gamete or embryo into the female reproductive system.
  • Establishment of ART Banks: The Bill defines an ART bank as an organization established to provide sperm or semen, oocyte, or oocyte donors to ART clinics or their patients.
  • ART Clinical Management: The Bill provides for the establishment of a National Register of Clinics and Banks, which will serve as a database of all clinics and banks in the country. The Registry will provide registration at ART clinics that will be valid for five years and renewable for another five years. Registration may be cancelled or terminated if the organization violates the provisions of the Bill.
  • National and State Boards: The Bill also provides for the establishment of National Boards and Government Marriages to regulate ART services. The National Board will advise the Central Government on policy matters relating to assisted reproductive technology.
  • ART Service Provider Rules: ART procedures can only be performed with the informed consent of both the person seeking ART services and the gamete provider.
  • Rights of the Child Born on ART: The Bill provides that a child born with the help of reproductive technology will be considered a natural child of an authorized couple and that child will be entitled to all the rights and privileges available to the natural child only from the authorized couple under any law currently in force.
  • Pre-implantation implantation: The bill stipulates that pre-implant genetic testing will be used to test an embryo for any known, pre-existing, genetic, or genetic diseases. The National Board will set pre-installation conditions.
  • Cases: Cases under this bill include clinics that provide sex selection, abandonment or exploitation of children born with ART, trafficking, buying, or importing human embryos and abusing a couple or donors involved in any way. Proposed prison sentences for offenses range from five to 12 years, with fines ranging from Rs 5 lakh to Rs 25 lakh.

What is Assisted Reproductive Technology (ART)?

  • Assisted Reproductive Technology (ART) incorporates medical procedures used primarily to address infertility.
  • It includes oral contraceptives that treat a woman's egg and a man's sperm.
  • Examples of ART services include
    • gamete donation (sperm or oocyte)
    • in-vitro-fertilization (egg fertilization)
    • pregnancy (the baby is not biologically related to the baby mother)

What are the rules regarding the use and acquisition of gametes and embryos?

  • A woman cannot be treated with gametes or embryos taken from more than one man or woman during one treatment cycle
  • The clinic cannot mix sperm in two people for these procedures
  • The foetuses should not be separated and used to combine twins to increase value
  • The donor's gamete or embryo should be stored for a period not exceeding 10 years.
  • Otherwise, there will be regulations for harvesting oocytes or embryos. For example, a person who donates an oocyte would be a woman who is always married and has at least one living child under the age of three. In addition, he can donate oocytes only once in his lifetime, and no more than seven oocytes should be collected from him.

What is the need for an ART Control Bill?

  • ART growth: ART market size is expected to reach $ 45 billion by 2026 (as per market speculation). Among Asian countries, India's ART market is ranked third. Undoubtedly, this too has led to the crisis in legal, social, and moral issues. The bill is important to protect women and children affected by abuse. In addition, about 80% of ART clinics in India are not registered. Therefore, to control unethical processes, ART control is essential.
  • Recommendations of Parliamentary Select Committee: The select committee that reviewed the Surrogacy Control Bill said it would be prudent to introduce the ART Bill before the Births Bill to establish a system for regulating ART clinics.

Note: Surrogacy is a form of infertility treatment where a third party is involved and that third person, the woman, will be the mother of the spouse. For ART, it is not always necessary for a third party to be involved.

What are the benefits of the ART Control Bill?

  • Evaluation of ART procedures: India does not currently have standard ART clinics currently available. The passage of this bill will ensure the universal implementation of ART throughout India.
  • Prevent patient abuse: The bill provides provisions to protect the rights of donors, an authorized couple and children born without ART. Therefore, it is unlikely that violators will operate within the system and exploit patients for maximum profit.
  • Protect reproductive rights: Without the registration and proper website of medical facilities and clinics that provide ART services, it is not possible to control services such as the discovery and termination of Medical Pregnancy. Therefore, the ART Regulation Bill will complement other related legislation and simplify reproductive rights.

What are the challenges associated with the ART Control Bill?

  • Excludes: The bill does not include lesbians, gays, lesbians, or transgender people (LGBTQ) or unmarried men (the Bill includes single women) in exercising the right to ART,
  • Lack of support for the poor: As ART procedures are expensive, the bill does not provide access to ART technology for the poor and disadvantaged sections. Therefore, the bill violates Article 14 (equality before the law and equal protection of the law) of the Constitution.
  • Many bodies: Both the ART Act and the Surrogacy Bill aim to establish multiple themes, which may result in duplication or lack of control.

What should the government do?

  • Make the bill inclusive: The bill should include LGBTQIA + single men in the ambit. In addition, ART service providers should establish informal ethics committees and accredited counselling services within their facilities.
  • Cost control: The cost of the process should be monitored successfully so that even the poor can benefit. In addition, the government can establish ART facilities at selected public hospitals to help the poor and marginalized.
  • Consider the Surrogacy Bill and the ART Bill together: The Acquisition Arbitration Bill and the ART Bill were pending in Rajya Sabha. It would be good if both Bills are considered together before they are passed. So the government must consider itself together.

Thus, all constitutional, ethical, medical and legal and regulatory grievances must be addressed prior to the passing of the ART Control Bill.

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