The Assisted Reproductive Technology Regulation Bill, 2020 – one the Government has billed as “historic” – has won the approval of the Union Cabinet in a significant overture towards regulation of the assisted reproductive technology sector.
Prime Minister Narendra Modi chaired the Cabinet meeting where the Bill secured the approval of ministers. The legislation outlines a number of regulations for providers of assisted reproductive technology services such as in-vitro fertilisation (IVF) and surrogacy and sets out the regulatory framework concerning the same. “The major benefit of the Act would be that it will regulate the assisted reproductive technology services in the country,” the Government has said. “Consequently, infertile couples will be more ensured/confident of the ethical practices in [assisted reproductive technology services].
As explained in a Government-issued press release, a “National Board shall lay down code of conduct to be observed by persons working at clinics, to set the minimum standards of physical infrastructure, laboratory and diagnostic equipment and expert manpower to be employed by clinics and banks. The states and union territories shall constitute the State Boards and State Authorities within three months of the notification by the Central Government.
“The State Board shall have the responsibility to follow the policies and plans laid by the National Board for Clinics and Banks in the State. The Bill also provides for [a] National Registry and Registration Authority to maintain a central database and assist the National Board in its functioning.”
The Government touted the Assisted Reproductive Technology Regulation Bill, 2020 as part of a package of reforms including the Surrogacy Regulation Bill, 2020 and the Medical Termination Pregnancy Amendment Bill, 2020, described as “path-breaking measures taken to protect women’s reproductive rights…taken together, the three proposed legislations create an environment of safeguards for women’s reproductive rights, addressing changing social contexts and technological advances.”
The Act also provides for penalising those who practice sex selection or who establish organisations on the black market to facilitate the illicit sales of human embryos or gametes. Another core provision is that the rights of children conceived through assisted reproductive technology be equal to those conceived biologically. It also provides for the rights of donors, stating “the oocyte donor needs to be supported by an insurance cover, protected from multiple embryo implantation.”
The impetus behind the Assisted Reproductive Technology Regulation Bill, 2020, the Government explained, is that the sector “has grown by leaps and bounds in the last few years.” However, whilst such technology “has given hope to a multitude of persons suffering from infertility”, the Government asserts that they have “also introduced a plethora of legal, ethical and social issues…in spite of so much activity in India, there is yet no standardisation of protocols and reporting is still very inadequate. The need to regulate the assisted reproductive technology services is mainly to protect the affected women and the children from exploitation.”
Infertility is on the rise in India, with one in ten affected. This has fostered a market for assisted reproductive technology services and, in tandem, the need for regulations. While some Government reforms, such as ones pertaining to commercial surrogacy, have been controversial, the move towards regulating service providers and the market is an understandable manoeuvre. As to how the industry itself reacts remains to be seen. In the interim, the approval of the Act by the Cabinet has been welcomed by some Government officials.
Union Minister of Health and Family Welfare Dr Harsh Vardhan welcomed the news in a tweet, expressing “heartfelt thanks” to Modi for approval of the Act which he deemed “historic.” Following the Act’s passage by the Union Cabinet, it shall be introduced in the forthcoming parliamentary session according to Vardhan.