Explained: What is the Assisted Reproductive Technology (Regulation) Bill 2021 passed by Parliament?

The Assisted Reproductive Technology (Regulation) Bill proposed to set up an ART bank to regulate/ensure the supply of sperm or semen, oocytes, or oocyte donors to ART clinics for their patients.

Union Health Minister Mansukh Mandaviya said that many Assisted Reproductive Technology clinics are running in the country without any regulation and there is a need to regulate these.

The Rajya Sabha today passed the The Assisted Reproductive Technology (Regulation) Bill, 2021. The ART bill was already passed by the Lok Sabha on the first of this month. The bill proposes to establish a registration authority and a national registry for all clinics and medical professionals working in the field. The bill also seeks to set standards and codes of conduct for fertility clinics and sperm banks in the country, prevent misuse as well as adopt safe and ethical practices.

Speaking on the Bill in Lok Sabha, Union Health Minister Mansukh Mandaviya said that many Assisted Reproductive Technology clinics are running in the country without any regulation and there is a need to regulate these as there are implications on the health of those who undergo the procedure. While there are millions of infertile couples who are today either opting or planning to opt for the technology and the sector growing by leaps and bounds in the last few years, the government felt the need to regulate these. The ART clinics are also one of the reasons behind increasing medical tourism in India. The ART clinics offer services like gamete donation, in-vitro-fertilization, intracytoplasmic sperm injection and intrauterine insemination.

What is an ART bank proposed under the law?
The Assisted Reproductive Technology (Regulation) Bill proposed to set up an ART bank to regulate/ensure the supply of sperm or semen, oocytes, or oocyte donors to ART clinics for their patients. Women above the legal age of marriage and below 50 and men above the legal age of marriage and below 55 can avail the services. To regulate the services offered by the clinics, a national board, a national registry and a registration authority.

National Board: The National Board will advise the government on policy matters besides monitoring rules and regulations. It has been also empowered to recommend any changes required in the law. The board will also set the minimum criteria like physical infrastructure, laboratory and diagnostic equipment and expert manpower for the ART clinics.

National Registry: The National Registry will maintain a central database on all such clinics and banks working in the country. The registry will provide the data to National Board for framing policies and guidelines.

Registration Authority: An officer above the rank of Joint Secretary in the Health Department will be its chairperson, the vice-chairperson will be above the rank of the Joint Director in the Health Department and other members will include eminent woman representing a women’s organization, an officer of the Law Department, and an eminent registered medical practitioner. The authority’s function will include granting, suspending, or canceling the registration of ART centres; to enforce the standards and supervise implementation of the law; to investigate complaints of any breach of provisions, to take legal action against the misuse of ART and conducting investigations. It can also recommend the required changes in regulations to the National and State Boards.

The bill has also set certain rules and guidelines for the ART clinics. These include ensuring the eligibility of the service taker, donors, providing professional counseling and informing the couples about advantages, disadvantages, costs, side effects, and risks etc. They will also have to make their client aware of the rights of a child born through ART while ensuring that data is kept confidential. The Bill also says that any treatment or procedure should not be carried out without the written consent of all the parties seeking ART. It also mandates insurance coverage in favour of the oocyte donor.

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