India has become the hub of the global fertility industry and medical tourism. In order to regulate India's fertility treatment industry, the Assisted Reproductive Technology (Regulation) Bill, 2020, will be considered for passing in the Lok Sabha this winter session.
The bill comes over a decade after the Indian Council of Medical Research drew the bill's first draft in 2008. 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 in the country.
The ART Bill provides for the "safe and ethical practice of assisted reproductive technology services", which includes: 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).
ART Bill 2020 outlines the need to formulate standard operating procedures to ensure "uniform costs" and "global quality standards" across India and a monitoring body to prevent the "commercialisation" of ART services.
In 2008 the reproductive segment of the Indian medical tourism market was valued at more than $450 million by the ICMR and was predicted to rise to $6 billion a year within a decade.
"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 the 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 bill further mandates ART clinics and banks to be registered under the National Registry of Banks and Clinics of India and will act as a central database.
State governments will appoint registration authorities for facilitating the registration process. The registration will be valid for five years and can be renewed for a further five years.
The bill further stipulates conditions for gamete donation such as a bank can obtain semen from males between 21 and 55 years of age, and oocytes from females between 23 and 35 years of age. An oocyte donor should be an ever-married woman having at least one alive child of her own.
In addition, the woman can donate oocyte only once in her life, and not more than seven oocytes can be retrieved from her. A bank cannot supply gamete of a single donor to more than one commissioning couple.
The party seeking ART services will be required to provide insurance coverage for the oocyte donor (for any loss, damage, or death of the donor). A clinic is prohibited from offering to provide a child of pre-determined sex. The Bill also requires checking for genetic diseases before the embryo implantation.
The bill's origins 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.
Last year, the ART bill was introduced in the monsoon session of Parliament, but the proceedings were curtailed due to Covid.
The bill provides for the registration of every ART clinic and egg/sperm bank in the country. The bill also specifies the eligibility criteria of gamete donors, how many times they can donate, and under what conditions.
The current bill was first tabled in the Lok Sabha on September 14 2020. On October 3, 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.
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