Bill to regulate assisted reproductive technology services passed in Lok Sabha

The Lower House of the Parliament on Wednesday passed a bill that seeks 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.

The Assisted Reproductive Technology (Regulation) Bill, 2020 was passed with a voice vote after a reply to the debate by Health Minister Mansukh Mandaviya.

The minister said that bill has been brought after due consultations and the need to regulate the assisted reproductive technology services is mainly to protect the affected women and children from exploitation.

"If there is no regulation, the unethical practices will increase," he said.

He said the national board and the state board shall be the same as proposed in the Surrogacy Bill, which is pending in the Rajya Sabha.

Members of various parties participated in the debate and gave their suggestions. The minister said that the government is open to more suggestions and these can also be considered when the rules are framed for the legislation.

The statement of objects and reasons of the bill states that Assisted Reproductive Technology has grown by leaps and bounds in the last few years. India has the highest growth in the ART centres and the number of ART cycles performed every year.

It states that assisted reproductive technology including in-vitro-fertilisation, has given hope to a multitude of persons suffering from infertility, but it has also introduced a plethora of legal, ethical and social issues.

India has over the years become one of the major centres of this global fertility industry, with reproductive medical tourism becoming a significant activity. Clinics in India offer nearly all the ART services--gamete donation, intrauterine insemination, in-vitro fertilization, intracytoplasmic sperm injection, pre-implantation genetic diagnostics and gestational surrogacy.

However, in spite of so much activity in India, there is yet no standardisation of protocols and reporting is still very inadequate and there is no law to regulate ART and it is regulated through guidelines.

The statement of objectives states that the oocyte donor needs to be supported by an insurance cover. Multiple embryo implantation needs to be regulated and children born through ART need to be protected.

"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 states.

"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 safe and ethical practice of assisted reproductive technology services," it adds.

The bill defines terms such as "assisted reproductive technology", "assisted reproductive technology clinic" and "commissioning couple".

It provides that 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 shall make an application to the Registration Authority within a period of sixty days from the date of establishment of the National Registry.

The bill provides that the assisted reproductive technology services shall be available to 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.

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

The bill states that the assisted reproductive technology clinics shall provide professional counselling to the commissioning couple and the woman about all the implications and chances of success of assisted reproductive technology procedures in the clinic.

They shall also inform the advantages, disadvantages and cost of the procedures, their medical side effects, risks including the risk of multiple pregnancies and any such other matter as may help the commissioning couple to arrive at an informed decision.

The bill provides for offences and penalties for the contravention of provisions.