Gap Between Black-Letter Law and Subordinate Realities:The Implementation Deficit of the ART (Regulation) Act, 2021
Keywords:
ART Act 2021, implementation deficit, reproductive rights, black-letter law, IVF regulation, India, surrogacy, judicial review, health lawAbstract
The Assisted Reproductive Technology (Regulation) Act, 2021 (ART Act) is the first attempt by the Indian government to create a comprehensive law to regulate a fertility industry that has long existed outside any regulatory framework, valued at USD 5–6 billion. The Act establishes a complex structure of both national and state boards, a National Registry, a requirement for clinics and banks to register with the National Registry, restrictions on gamete donors, and penalties. However, the differences between this statutory language and what actually happens in practice shows the implementation gap is massive. Only 219 of the 4,446 applicants for ART clinics are registered as of May 2023, marking a 4.9 per cent completion rate; and litigation taken up at the Supreme Court of India and various High Courts has highlighted the problems and internal inconsistencies in the subordinate rules and delegated legislation. The structure of the implementation gap as well as structural and institutional obstacles to its implementation are critically discussed in this paper. Based on existing cases, academic commentary, and policy review, it presents a case for the legislative over-ambition of the ART Act without capacity to back it up, leading to an over-restrictive eligibility criteria yet an inadequate scope of enforcement. The paper ends with ideas of reform which aim at filling the gap between theory and practice with respect to reproductive medicine in India.
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