A Guide into the Assisted Reproductive Technology (Regulation) Act, 2021

16 years, 8 drafts and 3 parliamentary committees later, the Legislature finally passed the Assisted Reproductive Technology (Regulation) Bill in December 2021. There was a paramount need for the legislation, especially considering the absence of regulatory protocols or statutory enforcement in the field of reproductive technology.

The Act, spread over six chapters, deals with the different matters concerning assisted reproductive technology including the setup of a national ART and Surrogacy Board and the registration and duties of ART banks and clinics. The Act aims to foster an ethical environment for the functioning of ART procedures through the clinics and banks, all while protecting women and children from exploitation. A brief explanation of certain important provisions is given below:

What is Assisted Reproductive Technology?

  • According to the Act, techniques that attempt to obtain a pregnancy by handling the gametes outside the body and transferring the gamete or the embryo into the reproductive system of the woman are called ART.

What are the ART Banks and Clinics as proposed under the Act?

  • Banks are organizations that are responsible for the collection, storage and supply of gametes to the ART Clinics or their patients. They are also responsible for the screening of the gamete donors and commissioning couples and conduct testing for any diseases.
    Clinics are premises equipped with requisite facilities and medical practitioners that carry out the procedures related to ART. They also advise and counsel the couples/woman to arrive at a well-informed decision with regards to the procedure, cost, side effects etc. The Government has also notified the Assisted Reproductive Technology (Regulation) Rules that further regulate the functioning of ART Banks and Clinics.

Who can avail ART services and procedures?

  • Any infertile married couple that is unable to conceive after 1 year of unprotected coitus or any other proven medical condition that prevents the couple from conception may utilize ART services. Additionally, a woman above the age of 21 years may also undergo such procedures.

Is there any age limit for procuring ART services?

  • Yes. Only females above the age of 21 and below the age of 50 years and males above the age of 21 and below the age of 55 years can obtain ART services from clinics.

Is there any age limit for engaging as a gamete donor?

  • Yes. ART Banks shall obtain semen from males between the age of 21 and 55, both inclusive and obtain oocytes from females aged 23 to 35. An oocyte donor can only donated oocytes once in her lifetime.

What are the rights of a child born through ART?

  • Any child born through ART shall be deemed to be the biological child of the couple and will be entitled to all rights and privileges akin to that of a natural child. The donor will also have to relinquish all parental rights over the child.

Is privacy maintained in such procedures?

  • All Banks and Clinics are required to maintain confidentiality surrounding the procedure/treatment. Disclosures can only be made to the Registry, the commissioning couple in case of emergencies or on receipt of a court order requiring the same.

What are the restrictions with respect to sex-determination and pre-implantation genetic testing?

  • Clinics cannot provide any party with a child of pre-determined sex. Sex determination at any stage is prohibited along with prescribing or administering anything that can increase the probability of a particular sex or determine it except to prevent or treat a sex-linked disorder/disease. Similarly, Pre-Implantation Genetic Testing can only be used to screen for pre-existing, heritable or genetic diseases.

What are the penalties for contravening the provisions of the Act?

  • Any party contravening any provision of the Act that has no specified penalty shall be punished with term that’s not less than 5 years but may extend to 10 years or a fine that may be not less than 10 lakhs but extend to 25 lakhs or both. Specific penalties are provided for advertisement of sex-selective ART procedures, sale or transfer or gametes, exploitation of the parties involved, running a racket and other such nefarious activities.