This blog is authored by Aiswariya Pratap Jena a fourth year student at School of Law, K.I.I.T. University
Every human being has the right to the enjoyment of the highest attainable standards of physical and mental health. The visibly rising issue of infertility can impede the enjoyment of such rights. According to the United Nations, infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse.
At present, India is the most populous country in the world, second only to its neighboring country, China and soon expected to surpass the latter in the coming years. However, the issue of infertility has been seen to be prominently increasing in India, which hinders such predictions and also disappoints young couples. According to the World Population Prospects Revision Report, 2017 of the United Nations, the fertility rate of Indians has come down by more than 50% from 4.97 to 2.3. Further it will be reduced to 2.1 during 2025 to 30 and 1.86 from 2045 to 50 and 1.78 from 2095 to 100.
The Assisted Reproductive Technology (Regulation) Bill (ART Bill), introduced in the Lok Sabha on 14th September, 2020 allows married infertile couples and women unto a certain age to commission ART procedures and a possible solution to the issue of infertility at large. As a consequence, infertile couples might be more ensured/confident of the ethical practices in ARTs and resort to such procedures as a solution.
Key features of the bill
In the beginning, the ART Bill seeks to define Artificial Reproductive Technologies as all techniques that seek to obtain a pregnancy by handling the sperm or the oocyte (immature egg cell) outside the human body and transferring the gamete or the embryo into the reproductive system of a woman, under Section 2(c). These include gamete donation (of sperm or egg), in vitro fertilization, and gestational surrogacy. However, such procedures can only be undertaken at the authorised ART clinics that have been registered under the National Registry of Banks and Clinics of India. The National Registry is to be established by the Central Government, effectively working from the date mentioned in a notification released, as per Section 9 of the Bill. Similarly, ART banks have to gain an authorisation from Clinics of India in order to store and supply gametes to such clinics, as posited under Section 13. Further, such clinics and banks will be registered only if they adhere to certain standards (specialised manpower, physical infrastructure, and diagnostic facilities).
The registration will be valid for five years(Section 16(6)) and can be renewed for a further five years(Section 17) , subject to cancellation and suspension upon non contravention to the provisions of the Bill. As per Section 16 of the Bill , the Registration Authority will grant registration within a period of 30 days, if all the compliances are met with. Amongst it, such clinic is prohibited from offering to provide a child of a pre-determined sex.
The National Registry would be established under the Bill and will act as a central database with details of all ART clinics and banks in the country. To facilitate the registration process, registration authorities would be appointed by the state government. In order to get registered and procure the services given by the clinics, a written informed consent of both the parties (the couple and the donor) has to be obtained as mentioned in Section 22 of the Bill. Such party will also be required to provide insurance coverage in the favour of the oocyte donor (for any loss, damage, or death of the donor).
As for the procedure, a male donor must be aged between 21 and 55 years of age, and the female donor between 23 and 35 years of age. It also places a pre requisite on the female donor to be a married woman having at least one alive child of her own (minimum three years of age). The woman can donate oocyte only once in her life and not more than seven oocytes can be retrieved from her. These compliances have been elaborated under Section 27 of the Bill.
Perhaps the most important element of the Bill is the part which asserts the rights of a child born through ART procedure. As per Section 31 of the Bill, such a child will be deemed to be the biological child of the commissioning couple and will be entitled to the rights and privileges that would be the prerogative of a biological child in usual circumstances. A donor will not have any parental rights over the child.
National and State boards constituted under the Surrogacy (Regulation) Bill, 2019 would also serve as the board for regulation of ART services. Key powers and functions, as elaborated in Section 5, of the National Board include:
(i) advising the central government on ART related policy matters,
(ii) reviewing and monitoring the implementation of the Bill,
(iii) formulating code of conduct and standards for ART clinics and banks, and
(iv) overseeing various bodies to be constituted under the Bill.
Penalties and Offences under the Bill
The Bill also sets a deterrent through penalties for offences, under Sections 33 and 34, such as (i) abandoning, or exploiting children born through ART, (ii) selling, purchasing, trading, or importing human embryos or gametes, (iii) using intermediates to obtain donors, (iv) exploiting commissioning couple, woman, or the gamete donor in any form, and (v) transferring the human embryo into a male or an animal. These offences will be punishable with a fine between five and ten lakh rupees for the first contravention. For subsequent contraventions, these offences will be punishable with imprisonment for a term between eight and 12 years, and a fine between 10 and 20 lakh rupees.
Standing committee report on the ART Bill
Ever since its introduction, the Bill was criticised and appreciated amongst the people due to its take on ART procedures, coupled with the implications of it. After much debate and discussion in the Houses of the Parliament and the public in general, the Standing committee on Health and Family Welfare, chaired by Prof. Ram Gopal Yadav submitted its report on March 19, 2021.
The committee observed that the role of the ART banks is not clear in the definition, and need for their roles to be clearly defined and the role of specialists appointed for that purpose needs to be mentioned. As per the Bill, every ART clinic and bank will have a grievance redressal cell. The Committee recommended that a 30-day timeframe should be provided for addressing the concerns of patients. In addition, an individual may approach Courts with complaints regarding ART services.
The Bill specifies that the data collected by ART clinics and banks must be transferred to the National Registry within a month of receiving the data. Such clinics and banks are also required to store the data for a 10-year period. The Committee noted that these are personal data which may lead to the identification of the commissioning couples, women, or donors. The Committee recommended that the personal data of patients and commissioning couples should be converted to a form in which a data principal (individual to whom the data belongs) cannot be identified. It was recognised that the Bill must introduce the provision for animosity of the data.
Drawbacks and loopholes in the Bill
There are a lot of observable drawbacks in the Bill, that is not only opposed to the current developments in the legal system but also opposed to the ever-evolving principles of constitutional morality.
The Bill allows for a married heterosexual couple and a woman above the age of marriage to avail the ART services and manifestly excludes single men, cohabiting heterosexual couples and LGBTQ+ individuals and couples from the ambit of the Bill. This is in direct contravention to the 2018 judgement of Navtej Singh Johar v. Union of India which advised the States to take positive steps for equal protection for same sex couples and decriminalised homosexuality.
It also seems to violate Article 14 of the Constitution and the right to privacy that has been opined to be an essential subset of right to life and personal liberty in the 2017 judgement of K.S. Puttaswamy v. Union of India, where the Supreme Court held that “the sanctity of marriage, the liberty of procreation, the choice of a family life and the dignity of being” concerned all individuals irrespective of their social status and were aspects of privacy.
The Bill restricts egg donation to a married woman with a child (at least three years old). Even here, egg donation as an altruistic act is possible only once a woman has fulfilled her duties to the patriarchal institution of marriage. Further, the egg donor is given little to no protection under the Bill. The Bill requires an egg donor’s written consent but does not provide for her counselling or the ability to withdraw her consent before or during the procedure.
Added to the drawbacks, there are a lot of careless overlaps between the ART bill and the Surrogacy (Regulation) Bill, 2019, which implies that either there needs to be complete revision of the Bills or need for getting rid of the overlaps in the ART bill and the Surrogacy bill. From the recommendations of the committee and the general loopholes observed, it can be seen that the Bill is poorly drafted. The terms such as “couple”, “infertility”, “ART clinics” should be better defined in order to leave no place for anomalous interpretation. In conclusion, there needs to be an all-inclusive review of the Bill so that the constitutional, ethical and regulatory concerns are not overlooked.