The Lok Sabha passing the Assisted Reproductive Technology Bill: An initiative that will help regulate IVF clinics

Considering it is one of the flourishing sectors, the Indian IVF market is now garnering attention and support from the Government as well.

By Dr. Prashant S Joshi,

The Indian fertility segment has been an ever-evolving market. It has been gradually gaining prominence and it is expected that India will soon emerge to be the leading market. Considering it is one of the flourishing sectors, the Indian IVF market is now garnering attention and support from the Government as well. The Lok Sabha passing the Assisted Reproductive Technology Bill is indeed a testimony for the same. 

The IVF segment and ART clinics receiving the government’s support

Over the last two decades, the fertility clinics have increased exponentially in India making it one of the largest IVF market at the global level. As a result, India is home to one of the major centres of the fertility industry and reproductive medical tourism is emerging to be a significant market. 

The Assisted Reproductive Technique clinics offer a plethora of services ranging from in-vitro fertilization, gamete donation, and intrauterine insemination, to intra-cytoplasmic sperm injection, pre-implantation genetic diagnostic and gestational surrogacy. However, despite being one of the proliferating markets, there is no standardization of protocols and even the reporting is inadequate. This proposed ART law will address the gaps and issues that exist in the industry and its sole aim is to protect women and children from exploitation via the use of Assisted Reproductive Technology. 

The Assisted Reproductive technology Bill: A viable step that would help regulate the IVF segment 

The Centre proposed the Assisted Reproductive Technology bill to regulate the sector that is expected to leapfrog in the times to come but requires support for now. It propagates ethical practices of Assisted Reproductive Technologies and aims at setting the protocols for conducting ART procedures and IVF techniques for IVF clinics and egg/sperm banks in the country. The bill is indeed a revolutionary step as it states that it should be mandatory for ART clinics to be registered under the National Registry of Banks and Clinics of India. 

The bill proposes that it is imperative for Assisted Reproductive Technology clinics to provide holistic counseling to a commissioning couple (an infertile married couple who approaches an ART clinic or bank for availing its services). They should inform the couple everything about the ART procedures including the details of process, the advantages, disadvantages, medical aftereffects, and the chances of success as well as the associated risks including those of multiple pregnancies. The couples are also required to go through the possibility of adoption and other such matters that would help them in making an informed and wise decision. 

The ART bill also enlists the age specifications for both the genders willing to avail ART services- for females; they should be above the legal marriageable age and below 50 years whereas for males, it is above the legal marriageable age and below 55 years. Furthermore, the bill mandates that an oocyte donor shall be an ever-married woman and it is imperative that she have at least one live child of her own who is of a minimum age of 3 years. It also states that such a woman will donate oocytes only once in her life and not more than seven oocytes shall be retrieved from her. The bill also enlists that banks can obtain semen from males between 21 to 55 years age group and oocytes from females can be between 23 and 35 years of age. Adding to it, the banks cannot supply the gamete of a single donor to more than one commissioning couple. 

This ART bill aims to ensure that children born through ART are provided all rights equivalent to that of a biological child. It focuses on the informed consent of donors and legalizes ART procedures for live-in couples and single women as well. One of the major goals of this bill is to provide insurance cover to the oocyte donor and protect her from multiple embryo implantations. The ART clinics and banks will also be responsible for conducting pre-implantation genetic testing to screen the human embryo for known, pre-existing, heritable, or genetic diseases. 

However, the bill strictly states that sex selection will be prohibited. Violations of the sex selection clause will lead to imprisonment of a minimum of 5 years and up to 10 years or a fine of not less than Rs. 10 lakh and up to Rs. 25 lakh or with both. In case of abandonment or exploitation of the child/children, selling embryos/gametes, exploitation of the commissioning woman and couple; the punishment would be prison term ranging between 8 and 12 years and fine of a minimum of Rs. 10 lakh that may go up to Rs. 20 lakh. 

The need and relevance of the ART bill

Aiming to break the taboos and the societal norms associated with IVF, it would be appropriate to say that this bill is indeed the dire need of the hour. It is a step in the right direction that will help set guidelines for Assisted Reproduction Technology clinics and banks. This bill also will help standardize the operating procedures to ensure uniform costs and global quality standards of the IVF process across the country. It will also put an end to unethical practices and will prevent the commercialisation of ART services. 

The need to regulate the functioning of ART clinics and IVF centres is essential to ensure that the services provided are ethical as well as the medical, social, and legal rights of the concerned parties, especially the donors are protected. Hence, this bill is a welcome step that will help in facilitating the same – catering to the hurdles that the segment faces as well as addressing sensitive issues such as gamete donation, IVF, etc. so that people can avail the ART services. However, the only drawback of this bill is that it excludes single men and LGBT community members and hence they cannot obtain ART services!

Summing up

The parliamentary standing committee had recommended bringing a law for the regulation of the ART clinics and banks along with the Surrogacy Regulation Bill. Hence, the operationalisation of the ART bill depends on the Surrogacy Bill. 

Until now, the majority of the clinics were unregistered and the IVF market, especially the ART segment, was not receiving the required support from the government. If this bill becomes the law, then the domain will attain the requisite assistance and power to grow. It would also be mandatory for the ART clinics to test the commissioning couples, women, and gamete donors as per the mentioned protocols. The clinics will then be able to offer global quality services to the couples and help them enjoy the joy of parenthood!

Initiatives in favor of and supporting the IVF segment such as this bill being proposed and passed from the Lok Sabha are essential because in the absence of regulation, unethical practices will increase. It is anticipated if this bill becomes the law, then, it would help drive the segment’s growth thereby upscaling the Indian IVF market at unimaginable levels!

(The author is Consultant – Reproductive Medicine & Clinical Director, Milann Fertility Centre, Indiranagar, Bangalore. Views expressed are personal and do not reflect the official position or policy of the Financial Express Online.)

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