Lok Sabha passes bill to regulate and supervise Assisted Reproductive Technology services

The Lok Sabha on Wednesday, December 1, passed a bill to regulate and supervise assisted reproductive technology procedures in clinics. The Assisted Reproductive Technology (Regulation) Bill, 2020 bill that sought to establish a national board and state boards for the regulation and supervision of ART clinics and ART banks for the safe and ethical practice of Assisted Reproductive Technology (ART) services, was passed with a voice vote after a reply to the debate by Union Health Minister Mansukh Mandaviya.

The minister said that the bill has been introduced mainly to protect affected women and children from exploitation. Informing that the bill has been proposed after due consultations and with the need to regulate the assisted reproductive technology services, he said, "If there is no regulation, the unethical practices will increase."

He further said that the national board and the state board shall be the same as proposed in the Surrogacy Bill, which is pending in the Rajya Sabha, as various party members participated in the debate and raised questions, and provided suggestions for the same. 

Assisted Reproductive Technology (Regulation) Bill, 2020

The Bill's statement of objectives and reasons states that in the past few years, Assisted Reproductive Technology has grown by leaps and bounds. Every year, India has the highest growth in the ART Centres and the number of ART cycles performed. 

Assisted Reproductive Technology that emerged as a solution and hopes to many individuals suffering infertility, also brought with it a plethora of legal, ethical, and social issues.

In terms of the global fertility industry, India has become one of the major Centres with reproductive medical tourism becoming a significant activity over the years. Nearly all ART services are offered at the Clinics in India including gamete donation, intrauterine insemination, in-vitro fertilisation, intracytoplasmic sperm injection, pre-implantation genetic diagnostics, and gestational surrogacy.

But there was no standardisation of protocols and it is regulated through guidelines as there is no law to regulate ART. 

Statement of objectives of the Bill

The statement of objectives states that the oocyte donor must have an insurance cover and multiple embryo implantation needs should be regulated while protection of children born through ART is a must. 

The statement of objectives stated, "The cryopreservation of sperm, oocytes, and embryo by the ART Banks need to be regulated and the proposed legislation intends to make Pre-Genetic Implantation Testing mandatory for the benefit of the child born through assisted reproductive technology."

It added, "There is a need to regulate ART clinics and banks by establishing the National Board, the State Boards, the National Registry and the State Registration Authorities for the regulation and supervision of assisted reproductive technology clinics and the assisted reproductive technology banks, for prevention of misuse and for the safe and ethical practice of assisted reproductive technology services."

What does the Bill define?

The bill that defines terms such as "assisted reproductive technology", "assisted reproductive technology clinic" and "commissioning couple" provides that the clinics shall make an application to the Registration Authority within a period of 60 days from the date of establishment of the National Registry. The clinics that come under the pursuit of the bill include the existing assisted reproductive technology clinics and the assisted reproductive technology banks, as on the date of the enactment of the proposed legislation, conducting assisted reproductive technology procedures partly or exclusively. 

According to the bill, a woman above the legal age of marriage and below the age of 50 and a man above the legal age of marriage and below the age of 55 can avail the assisted reproductive technology services. 

It provides that an oocyte donor as an ever-married woman must have at least one live child of her own with a minimum age of three years. It further states that not more than seven oocytes can be retrieved from the donor and she can donate oocytes only once in her life. 

The bill states that professional counselling on the implications and chances of success of assisted reproductive technology procedures in the clinic shall be provided to the commissioning couple and the woman. 

(With ANI inputs)

Image: PTI