The ART (Regulation) Act of 2021 is a game-changer

When Kanupriya Agarwal, the world’s second and India’s first IVF kid, was born 43 years ago in Pune, Maharashtra, no one could have predicted that 8 million babies would be produced using various assisted reproductive technologies (ART), including in-vitro fertilization, during the next four decades (IVF). Of 60–80 million couples, suffering from infertility every year worldwide, an EY report in 2015 revealed that almost 27. Five million teams in India are impacted by it. The double-digit growth of infertility in India has made it a personal and public health issue. It is more substantiated by the fact that the total fertility rate (TFR) has declined from 2.7 children (NFHS-3, 2005-06) to 2 (NFHS-5, 2019-20) per woman in the last 15 years.

A recent study valued the Indian in-vitro fertilization (IVF) market to grow from USD 478 million in 2018 to USD 1453 million by 2026. The growth of ART clinics in India is among the highest globally. These are a vital part of medical tourism.

Since the introduction of the ART bill in 2008, 13 years ago, the passing of Assisted Reproductive Technology (Regulation) Act, 2021, by the Government of India in Parliament is a watershed moment and will bring a paradigm shift for healthcare providers and couples both. The new law aims to regulate and supervise the ART clinics and banks, prevent misuse and promote safe, ethical practices of ART procedures to address reproductive health issues.

Five significant changes will be seen in 2022, post enforcement of the ART Act, 2021. First is creating a regulatory body titled National ART Board, which will review and monitor the Act’s implementation and set the minimum standards of physical infrastructure, laboratory and diagnostic equipment, and specialized workforce employed by clinics and banks. The second is the establishment of the National Registry of ART clinics and banks. As per the Ministry of Health and Family Welfare (MOHFW), the total number of ART clinics is likely more than 40,000, but only 1657 clinics and banks are registered with ICMR. The third change will impact the way clinicians practice IVF in India. No ART clinic shall perform treatment unless an insurance cover of 12 months for the oocyte donor, by the commissioning couple or woman, is provided through an insurance company or agent for a guarantee of compensation for specified loss, damage, complication, or death of oocyte donor during the process of oocyte retrieval. All clinics shall provide professional counselling to the commissioning couple and women about the implications (advantages and disadvantages) and chances of success of ART procedures.

All clinics and banks will have to submit every month online to the National Registry detailed records of all donor’s oocytes, sperm, or embryos, used or unused, screened, maintained, and supplied. The new ART law will allow retrieving not more than seven oocytes from a single donor, and she can only donate oocytes once in her lifetime. The fourth change will impact the couple’s lives and the child born through the ART procedure. Now, the child born will be considered the couple’s biological child and shall be entitled to all rights and privileges available to a natural child.

Lastly, no ART clinic or bank shall issue, publish, distribute or communicate any physical or digital advertisement regarding facilities for sex-selective ART procedures. If any clinic or bank commits an offense under the new law, the executive head of the clinic or bank shall be deemed guilty of the crime and punishable with imprisonment between five and ten years or a fine between ten and twenty lakh rupees. These offenses have been made bailable and cognizable, which means a warrant is not required to start an investigation or arrest the professional.

The utilization of ART is linked to the financial burden on the couple. The cost of ART in India per IVF treatment cycle, excluding medicines and blood tests, ranges from ₹50,000 to 150,000. As infertility primarily affects the salaried urban middle-class population, all private and public health insurance providers will have to offer health insurance covers to comply with ART Act, 2021.

To effectively address infertility, health policies need to recognize that infertility is a disease that can often be prevented, thereby mitigating the need for costly and poorly accessible treatments. Incorporating fertility awareness in national comprehensive sexuality education programs for adolescents and adults, promoting healthy lifestyles to reduce behavioral risks, and preventing complications of unsafe abortion, are policy and programmatic interventions that the government can consider implementing.

The article is co-authored by Dr KS Uplabdh Gopal, Medical Intern.