Introduction
The Assisted Reproductive Technology (Regulation) Act 2021 was enacted to bring order to an industry that had operated in a regulatory vacuum for over two decades. India’s fertility industry had grown to be among the largest in the world, serving both domestic patients and a substantial proportion of medical tourists seeking infertility treatment. The absence of binding regulatory standards had produced significant inconsistency in clinical practice, inadequate protection for donors and patients, and unresolved legal questions about the parentage and inheritance rights of children born through donated gametes.
The Act, read together with the Surrogacy (Regulation) Act 2021 as companion legislation, attempts to establish a comprehensive framework. But the ART Act’s provisions on the most legally contested questions, including the parental rights of gamete donors, the legal status of cryopreserved embryos, the child’s right to know their genetic origins, and the consent framework governing embryo disposition in the event of the donor’s death or the breakdown of the commissioning relationship, contain significant gaps that will generate litigation as the Act’s provisions are applied to real circumstances. This article examines those gaps, situates them in the broader context of comparative ART law, and suggests a framework for addressing them.
Legal Framework
The ART Act 2021 establishes a tiered regulatory structure. At the national level, the National Board for Assisted Reproductive Technology and Surrogacy, established under both the ART and Surrogacy Acts, sets standards, policies, and codes of conduct. At the state level, State Boards perform implementation functions, and ART clinics are registered with and supervised by the relevant State ART Authority. ART banks, which are regulated institutions holding gamete (sperm and egg) donations, are established under the Act and must maintain the National ART Registry.
Gamete donation under the Act is anonymous: donors do not know the identity of the recipients and recipients do not know the identity of the donors. The Act requires that each donor may donate gametes to no more than one ART bank, and that an ART bank may supply gametes of one donor to no more than one commissioning couple. These provisions were designed to prevent the multiplication of half-siblings and to reduce the genetic impact of a single donor on the population.
The Act addresses parental status in Section 29, which provides that the child born through ART is deemed to be the legitimate child of the commissioning couple for all purposes, including inheritance, and that the donor of gametes has no parental rights or obligations in respect of such a child. This provision is legally clear in the straightforward case of an ART-conceived child born to the commissioning couple. It becomes considerably less clear in cases involving divorce, death, or gamete donor identity disputes.
The consent provisions for embryo disposition are addressed in Section 21, which provides for the written consent of both gamete providers before any use of embryos created from their gametes. The Act does not, however, provide a detailed framework for what happens when consent is withdrawn, when the relationship between the gamete providers breaks down before embryo use, or when one gamete provider dies.
Judicial Developments
The ART Act 2021, having come into force recently, has not yet generated an extensive body of decided case law in Indian courts. However, several constitutional challenges and interpretive questions have already emerged. In 2023, a petition was filed before the Delhi High Court challenging the age restrictions on gamete donors imposed by the ART Act (which restricts egg donation to women between 23 and 35 and sperm donation to men between 21 and 55), arguing that these restrictions arbitrarily prevent qualified donors from contributing and impose undue burdens on commissioning parties seeking genetically compatible donors. The petition remained pending for decision as of 2024.
Questions about the ART Act’s interaction with personal law inheritance frameworks have been raised in practitioners’ submissions before Family Courts, though no reported judgment has yet directly resolved the question of whether a donor-conceived child can inherit from a gamete donor who is later identified (or self-identifies) in contexts where the anonymity provisions break down. The concern is real: if the anonymity of ART donation is not maintained throughout the child’s life and the child’s genetic parentage becomes known, the personal law inheritance framework may treat the donor as a biological parent with corresponding inheritance implications that the Act’s Section 29 deeming provision was designed to prevent.
The question of posthumous use of gametes has not yet been judicially addressed in India. Section 21’s consent requirements, read carefully, appear to require fresh consent before each use of cryopreserved gametes or embryos, which would normally prevent posthumous use in the absence of advance written consent. But the practical reality of fertility treatment is that couples routinely cryopreserve embryos with the intention of using them for future pregnancies, without necessarily executing advance directives specifying the fate of those embryos in the event of the other partner’s death. Whether a surviving partner can use cryopreserved embryos after the death of their partner, and what the legal status of a child born from such use would be for inheritance and intestacy purposes, are questions that will require judicial resolution.
Contemporary Issues and Analysis
The most philosophically contested issue in ART law, both in India and internationally, is the tension between donor anonymity and the donor-conceived child’s right to know their genetic origins. The ART Act’s anonymous donation model was chosen partly to encourage donation (donors are more willing to contribute if their identity will not be disclosed) and partly to protect the commissioning family from unwanted claims by the donor or unwanted intrusions into the parent-child relationship. These are legitimate considerations. But they are in direct tension with the growing recognition, drawn from clinical psychology and from comparative legal experience, that donor-conceived individuals have a significant interest in knowing their genetic origins for both psychological and medical reasons.
The conflict between the anonymous donation model and the child’s right to know is especially stark when viewed against European human rights jurisprudence. The European Court of Human Rights has held in a series of cases, beginning with Gaskin v. United Kingdom (1989) and developed in Odievre v. France (2003), that the right to obtain information about one’s origins is protected by Article 8 of the European Convention on Human Rights (right to respect for private and family life), though this right may be balanced against the competing rights and interests of donors and the commissioning family. Several Council of Europe states have accordingly moved toward non-anonymous donation or toward donor-conceived individuals having access to identifying information when they reach adulthood.
The legal status of cryopreserved embryos is a separate and equally contested issue. Embryos occupy an uncertain position in the law’s taxonomy: they are not persons (and cannot be, under any secular legal framework that permits their creation, use, and disposal), but they are not simple property either, because of the intense personal significance they carry for the individuals whose gametes created them and because of their potential to become persons. Some legal systems treat embryos as a sui generis category, subject to specific rules that do not assimilate them to ordinary property. The ART Act does not expressly address the legal status of embryos, creating a vacuum that courts will eventually have to fill.
When a commissioning couple divorces before cryopreserved embryos are used, the question of what happens to those embryos is one of the most difficult in family law. One partner may wish to use the embryos to have a child; the other may object to being a genetic parent of a child born to their former spouse. The embryo disposition question in divorce has generated extensive litigation in the United States and United Kingdom, with most courts resolving it against compelled parenthood: the partner who does not wish to use the embryos typically prevails, on the ground that no person can be compelled to become a genetic parent against their will. Indian Family Courts will face this question, and the ART Act’s silence on the divorce-embryo disposition scenario means they will have to reach a result through general principles without specific statutory guidance.
Comparative and International Perspective
The United Kingdom’s Human Fertilisation and Embryology Act 1990 (substantially amended by the HFE Act 2008) provides the most comprehensive model in common law jurisdictions for the regulation of ART and embryo use. The UK system operates through the Human Fertilisation and Embryology Authority (HFEA), an independent regulatory body with extensive powers over licensed clinics and ART banks. The HFE Act provides detailed consent provisions under Schedule 3: gamete donors can consent to the storage and use of their gametes in ART treatment, can specify the purposes for which their gametes may be used, and can withdraw or vary their consent at any time before fertilisation (in the case of egg or sperm) or before implantation (in the case of an embryo). The case of Evans v. United Kingdom (2007), decided by the Grand Chamber of the European Court of Human Rights, confirmed that a gamete donor could withdraw consent to the use of embryos created from their gametes even after the commissioning relationship had broken down, and that this withdrawal right was consistent with Article 8 ECHR.
The UK moved to a non-anonymous donation model in 2005, when regulations came into force allowing donor-conceived individuals to obtain identifying information about their donor upon reaching age 18. This change was prospective only: donations made before 1 April 2005 remain anonymous. The move to non-anonymity was accompanied by donor recruitment campaigns and has been broadly accepted by the fertility treatment community, though it initially caused some decline in donor availability.
Australia’s approach to donor-conceived persons’ access to information is among the most progressive globally. Victoria, New South Wales, and Western Australia have enacted legislation creating registers of donor information and giving donor-conceived individuals access to identifying information without age restriction (in some states) and providing a mechanism for voluntary contact between donor and donor-conceived child if both register a willingness to be contacted.
Practical and Policy Implications
The ART Act’s gaps on embryo disposition in the context of divorce and death, and its silence on the child’s right to know genetic origins, create significant practical problems for commissioning couples, gamete donors, ART clinics, and children born through ART. Clinics operating under the Act are left without clear guidance on what to do when a commissioning couple separates before embryo use, when one partner withdraws consent, or when one partner dies. The absence of advance directive requirements means that many of these situations will arise without any documented intention from the parties about how they wished the situation to be resolved.
For the inheritance framework, the ART Act’s Section 29 deeming provision that treats the donor-conceived child as the legitimate child of the commissioning couple creates clarity in the normal case but does not address the situation where the commissioning couple divorces, where the donor’s identity is discovered through commercial DNA testing (now widely available), or where the donor later claims a parental relationship. The interaction between the Section 29 deeming provision and personal law inheritance rules needs to be worked through in cases involving Hindu Succession Act, Muslim personal law, and Indian Succession Act frameworks.
Suggestions and Reforms
The ART Act should be amended to include a comprehensive Schedule governing embryo consent, modelled on Schedule 3 of the UK’s HFE Act, specifying the form of consent required for embryo creation, storage, and use, the procedure for varying or withdrawing consent, the consequences of withdrawal, and the disposition of embryos in the event of the death of one or both gamete providers or the breakdown of the commissioning relationship.
The Act’s anonymous donation model should be reconsidered in favour of a non-anonymous framework that permits donor-conceived individuals to access identifying information about their genetic parents on reaching the age of majority. This transition, as the UK experience demonstrates, can be managed without destroying the donation system if it is accompanied by appropriate support and communication campaigns.
The National ART Registry should be required to maintain a donor identity database that is kept separate from the registry records accessible to commissioning families but is preserved for potential access by donor-conceived individuals, enabling the transition to non-anonymity to be implemented practically when the policy decision is made.
The Law Commission of India should examine the legal status of cryopreserved embryos and produce a report addressing the question within the framework of Indian constitutional law and personal law inheritance, providing a basis for specific legislative provision.
Conclusion
The ART Act 2021 represents a significant legislative achievement in bringing India’s fertility industry into a regulatory framework. But the Act’s provisions on the most difficult legal questions, including the status of embryos, the rights of donors, the child’s right to know their genetic origins, and the consent framework for disputed embryo use, are underdeveloped relative to the complexity of the problems they are intended to address. These gaps will generate litigation, impose costs on families navigating an already emotionally demanding process, and leave Indian courts without adequate legislative guidance on questions of genuine philosophical and legal difficulty.
The comparative experience of the United Kingdom, Australia, and other jurisdictions that have been grappling with ART regulation for longer than India offers a rich source of legislative models and judicial approaches. India’s lawmakers and courts would do well to engage carefully with that experience as the ART Act’s provisions are tested in practice over the coming years.
