New Delhi: The first draft of a bill to regulate the mammoth fertility treatment industry was drawn up way back in 2008 by the Indian Council of Medical Research (ICMR). After many twists and turns, its latest iteration, the Assisted Reproductive Technology (Regulation) Bill, 2020, was listed for consideration by the Lok Sabha Monday.
The House was adjourned without the ART bill being taken up but the government hopes to pass the legislation in the winter session of Parliament.
The ART bill, which was approved by the Union Cabinet last year, seeks to set minimum standards and codes of conduct for fertility clinics and egg/sperm banks.
The bill provides for the “safe and ethical practice of assisted reproductive technology services”, including egg or sperm donation, in-vitro fertilisation (IVF), intrauterine insemination (IUI), and gestational surrogacy. The bill also aims to introduce protections for egg donors, gestational surrogates, and children conceived through ART services.
The origins of the bill can be traced back to the “National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India”, drafted by the ICMR in 2005. Three years later, the ICMR came out with the draft ART (Regulation) Bill and Rules 2008.
In an August 2009 report, the Law Commission of India pointed out that the draft bill was “incomplete” but outlined the need for legislation to regulate ART clinics and safeguard the “rights and obligations” of all parties to a surrogacy.
Last year, the ART bill was introduced in the monsoon session of Parliament but the proceedings were curtailed due to Covid, leading to further delay.
The need for ART regulation in India
India today is a hub of the global fertility industry with medical tourists flocking to the country for a variety of services.
These include gamete donation (the use of donor sperm or eggs), intrauterine insemination (a procedure in which sperm is artificially inserted into the uterus), in-vitro fertilisation (the egg is fertilised by sperm outside the body and then transferred to the uterus), intra cytoplasmic sperm injection (a form of IVF in which a live sperm is injected into the centre of an egg), gestational surrogacy (in which a surrogate carries the baby in her uterus but has no genetic link to it), and preimplantation genetic diagnostics (the screening of an embryo for genetic conditions prior to implantation/pregnancy).
For these and other fertility procedures and services, a Rajya Sabha standing committee report on the ART Bill 2020 outlined the need to formulate standard operating procedures to ensure “uniform costs” and “global quality standards” across India.
The committee also noted that a monitoring body should be set up to prevent the “commercialisation” of ART services by private players. The committee report pointed out that in 2008 the reproductive segment of the Indian medical tourism market was valued at more than $450 million by the ICMR and was, back then, predicted to rise to $6 billion a year within a decade.
In the preamble of an earlier draft of the bill, the ICMR had noted that there had been an “exponential growth” in fertility clinics, and that this could lead to unethical or exploitative practices.
“As of today, anyone can open infertility or assisted reproductive technology (ART) clinic; no permission is required to do so. There has been, consequently, a mushrooming of such clinics around the country,” the draft bill said. “In view of the above, in public interest, it has become important to regulate the functioning of such clinics to ensure that the services provided are ethical and that the medical, social and legal rights of all those concerned are protected,” it added.
The 2020 bill addresses these concerns as well.
Provisions of the bill
The bill provides for the registration of every ART clinic and egg/sperm bank in the country. The registration is subject to their meeting certain laid-down standards. The bill also specifies the eligibility criteria of gamete donors, how many times they can donate, and under what conditions.
Offences under the bill include clinics offering sex selection, abandoning or exploiting children born through ART, the selling, buying, or importing of human embryos, and exploiting the couple or donors concerned in any form. Proposed jail terms for violations range from five to 12 years, and fines from Rs 5 lakh to Rs 25 lakh.
The objectives of the bill as laid down in the standing committee report are:
(i) To regulate ART services and protect the women and children involved from exploitation.
(ii) To provide insurance cover for egg donors and protection from multiple embryo implantation (due to the health risks involved for mother and child).
(iii) To provide rights to children born through ART equivalent to rights provided to biological children.
(iv) To regulate cryopreservation [cold storage] of sperm, eggs, and embryos by ART banks.
(v) To make pre-implantation genetic testing mandatory for the benefit of a child born through assisted reproductive technology.
(vi) To ensure proper registration of ART clinics and banks.
Related to the ART Bill is the Surrogacy (Regulation) Bill 2019 that seeks to regulate surrogacy. The select committee of Parliament that had examined that Bill had asked for the ART Bill to be passed first.
The journey since 2020
The present bill was first tabled in the Lok Sabha on 14 September 2020. On 3 October last year, the bill was referred — by the Rajya Sabha chairman in consultation with the Lok Sabha Speaker — for further examination to a department-related parliamentary standing committee on health and family welfare.
The standing committee tabled its report in Parliament on 19 March 2021. It raised several concerns, including the use of the word “industry” for ART clinics, the proliferation of private clinics and the paucity of government-run ART services, the differential and high pricing across clinics, and the fact that many IVF centres did not employ “trained and skilled ART experts”.
The committee spelled out that formulating SOPs, establishing uniform costs, and a global standard of services had to be ensured “at every level”.
The committee said that a monitoring mechanism under the overall guidance of a national board had to be set up to “prohibit unbridled commercialisation of the ART services”, adding that the profit motive led to some private operations conducting sex-selection and promoting “made-to-order” babies that could “adversely affect the sex ratio in the country”.
(Edited by Asavari Singh)