The Assisted Reproductive Technology (Regulation) Bill, 2020, was introduced in the Lok Sabha during the Monsoon session following the advice of a Rajya Sabha Select Committee on the Surrogacy (Regulation) Bill, 2019, which recommended that an ART law precede the Surrogacy Bill.
The Bill aims to regulate and supervise ART clinics and ART banks, prevent misuse and promote safe and ethical use of such services, and prevent exploitation of affected women and children.
ARTs are a range of medical interventions that aid reproduction, including procedures such as in vitro fertilisation and oocyte donation. The Bill is the latest version in a series of similar proposed legislation over the last twelve years. ARTs provide the means for those who, due to various reasons, are unable to reproduce and exercise their reproductive rights.
However, many of the technologies are typically invasive to women’s bodies, often medically risky for both the woman and the child born as a result of ART, are sometimes experimental in nature and not backed by robust evidence of effectiveness and safety. These risks and harms, particularly to women, are exacerbated in an environment where unfettered profit motives drive fertility services.
ART clinics and banks in India are overwhelmingly in the private sector and contribute to a multi-million dollar industry which has proliferated without any regulation or standardised protocols for treatment and services. Clinics often make exaggerated claims of success rates of treatments, fail to provide adequate information on the risks, side-effects, costs and alternatives to procedures and encourage overtreatment. In some cases, alleged negligence has led to deaths of oocyte donors.
The ART Bill can be a timely step towards addressing these concerns, promote reproductive autonomy and protect the rights of service users through clear standards and protocols for treatment and care. For this to be the case, gaps and omissions in the Bill, some of which are discussed here, need to be addressed.
The Bill leaves it to the discretion of the Central government to establish a national registry of ART clinics and banks. This would comprise a database of all ART clinics and banks in the country and include services offered and “outcomes of their services”. Since such information is vital for persons to make informed decisions while seeking ART services, the Registry must be mandatorily established and publicly accessible.
The Bill mandates that clinics provide certain critical information to clients for informed decision-making, but additional elements must be added. Clinics should be obliged to provide information on the actual success rates of the procedure in the clinic as well as nationally and internationally.
Further, they should be required to provide reasons for recommending a particular treatment, and counsel clients on the possibility of adoption when it is in their best interests. Counselling must also be an ongoing process, not a one-time formality. Most of these elements were present in previous versions, but are absent in the present Bill.
In a sharp departure from current practice on sourcing donor oocytes and semen, the Bill bans the sale of gametes, but does not clarify how and from whom donor gametes are to be obtained. Further, it does not require the provision of counselling and accurate information about the risks, harms and consequences of oocyte donation to donors.
Oocyte retrieval is potentially harmful to the woman’s health, a fact that the Bill itself recognises. Given this, the Bill must mandate counselling and written informed consent of the donor. While the Bill provides for insurance for the oocyte donor in case of damage or death during the process of retrieval, it should but does not specifically deal with the liability of banks and clinics in cases of negligence.
Data and privacy
The Bill must also provide robust protections for client data. Clinics and banks are supposed to provide all information pertaining to client enrolment, procedures, complications and outcomes to the national registry through a system of online submission.
The registry, in turn, is to share the “data generated’” with the National Board for research and policy formulation. Instead of sharing non-identifiable anonymised data, the necessity for sharing such granular information is unclear and raises concerns around client confidentiality and privacy. Instead, information on individual clients and their treatment should remain decentralised with the respective clinics and banks, which should be mandated to safeguard it by following data security protocols and measures, with remedies provided in case of a breach.
Another issue of concern in the Bill is that it allows only married couples and (perhaps) single unmarried women to access ARTs. In doing so it discriminates against and interferes in the reproductive autonomy and privacy of single men, trans and intersex individuals, and those in live-in and queer relationships.
As such it impedes on the right to freely decide on intimate matters such as reproduction and family formation. It is untenable that while single men are allowed to adopt children, and those born from live-in relationships are considered legitimate children, such familial arrangements are denied legitimacy under the Bill. Depriving people in queer or co-habiting relationships and trans and intersex individuals from procreating through ARTs denies their full personhood, further entrenching their marginalisation and exclusion.
A Bill to regulate ARTs has been long awaited. But this iteration will do little to regulate the fertility industry and address the many legal, ethical, medical and social issues implicated in the use of ARTs. The government must provide an opportunity for meaningful and widespread public consultation on the Bill, and draft a law that is responsive to the rights and health of ART users.
Gargi Mishra is Research and Advocacy Officer at the Centre for Health Equity, Law and Policy, Indian Law Society, Pune.
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