Govt needs to make ART Act more inclusive

To regulate and supervise Assisted Reproductive Technology (ART) clinics and banks and to protect donors and women undergoing ART from the health consequences related to risky and illegal treatments, the Union Health Ministry had come out with the Assisted Reproductive Technology (Regulation) Act, 2021.

The Act is also intended for prevention of misuse, safe and ethical practice of ART services for addressing the issues of reproductive health where ART is required for becoming a parent or for freezing gametes, embryos, embryonic tissues for further use due to infertility, disease or social or medical concerns. Even though the ART (Regulation) Act was notified by the Health Ministry on December 2021, the ministry notified the Rules only recently including the registration process, staff requirement, minimum equipment required and the license granting format for ART in the country.

Under the new law, all infertility clinics, ART banks and research organizations using human embryos are required to register themselves with the registration authority. Till then, anyone could open infertility or ART clinics in any part of the country as no permission was required for it. It is a fact that in the recent times, India has become one of the major centres of fertility treatment industry, with reproductive medical tourism becoming a significant activity, mainly because of higher success rates and affordable cost.

Besides regulating ART clinics and banks, the objectives of the Act include prevention of abuse, and the safe and moral provision of ART services. The Act also intends to protect the affected women and children from exploitation, support the oocyte donor with an insurance cover, regulate multiple embryo implantation and protect the children born through ART. The Act, further, aims to regulate cryopreservation of sperm, oocytes and embryos by the ART Banks and intends to make Pre-Genetic Implantation Testing mandatory for pre-existing, heritable or genetic diseases only for the benefit of the child born through ART. Undoubtedly, the Act is a significant and decisive step towards reducing the threat of unlicensed and illegal ART facilities in the country.

According to a conservative estimate, there are more than 40,000 ART clinics spread across the country. This resulted in a variety of legal, moral, and social problems that called for standardized protocol. Regulation of infertility clinics has been a major issue in the country for a long time now. It is clear from the past experiences that the advent of any new technology that affects mankind raises several technical and moral dilemmas and poses many ethical and technical challenges. And ART cannot be an exception.

For the last more than three decades, the country witnessed the establishment of thousands of infertility clinics. In the Indian context where barrenness is looked down upon, infertile patients looked up to these infertility clinics as the last resort to parenthood. Many of these technologies require enormous technical expertise and infrastructure. But, in the absence of a regulation, many of these clinics did not have the adequate trained manpower and infrastructure facilities to deliver these highly sophisticated technologies and even services provided by some of these clinics were highly questionable.

In several cases, the infertile couples were cheated by providing relatively simple procedure and charged for complicated and expensive procedures. It was under this background, the government, at last, came out with the ART Act. The Surrogacy (Regulation) Act, 2021, which only recognises altruistic surrogacy as legal, was also introduced concurrently with this ART Act. Although these Acts eventually regulate the industry, they also raise a variety of legal issues, including rights, scientific advancements, international surrogacy, obligations, and moral conundrums.

Obviously, the Act is a step in the right direction. But, the Act has fallen short of addressing several serious issues including costs of the services and prohibiting single men, transgenders and homosexual couple from availing ART services. The Act prohibits unmarried men, divorced men, widower men, heterosexual couples who are not married but are cohabiting, transgender people, and homosexual couples (whether married or cohabiting) from receiving ART services. This exclusion of these sections of people is significant since the Surrogacy Act also prohibits the aforementioned individuals from using surrogacy as a method of reproduction. Additionally, the Act is only applicable to commissioning couples who have been unable to conceive after one year of unprotected coitus. Its application is therefore constrained, and individuals who are disqualified have fewer options when it comes to getting pregnant. Another issue is that the costs of the services are not regulated. Now, the government should address these issues raised by the experts, including the gynaecologists and IVF specialists.

(The author is freelance journalist with varied experience in different fields)