Recently, the Lok Sabha has passed the Assisted Reproductive Technology (Regulation) Bill, 2021. The Bill seeks to regulate and supervise assisted reproductive technology clinics and banks, prevent misuse of the technology, and promote the ethical practice of the services. The bill has excluded live-in couples, single men, and the LGBTQ community.
What is Assisted Reproductive Technology (ART)?
- Assisted reproductive technology (ART) refers to fertility treatments and procedures that can help with difficulties or an inability to conceive children.
- ART techniques involve the manipulation of eggs, sperm, or embryos to increase the likelihood of a successful pregnancy.
- It works by removing eggs from a woman’s body. The eggs are then mixed with sperm to make embryos. The embryos are then put back in the woman’s body.
- In vitro fertilization (IVF) is the most common and effective type of ART.
Surrogate vs. gestational carrier
- ART procedures sometimes use donor eggs, donor sperm, or previously frozen embryos. It may also involve a surrogate or gestational carrier.
- A surrogate is a woman who becomes pregnant with sperm from the male partner of the couple.
- A gestational carrier becomes pregnant with an egg from the female partner and the sperm from the male partner.
- The most common complication of ART is a multiple pregnancy. It can be prevented or minimized by limiting the number of embryos that are put into the woman’s body.
What is Infertility?
- Infertility is when people cannot conceive after a period of regular sexual intercourse without the use of birth control.
- Primary infertility: Women who are currently married for more than 5 years, currently not pregnant, having no terminated pregnancy, never used contraceptives and have zero total children ever born.
- Childlessness: Women who are currently married for more than 5 years, currently not pregnant, having no terminated pregnancy, never used contraceptives and have no living children.
- Census of 1981 estimates infertility in India around 4-6 percent and according to NFHS-1 childlessness is around 2.4 percent of currently married women over 40 years in India.
- Childlessness in India is around 5.5 percent for 30-49 age group and 5.2 percent for 45-49 age group.
- According to World Health Organization estimate the overall prevalence of primary infertility in India is between 3.9 to 16.8%.
- In Indian states prevalence of infertility varies from state to state such as 3.7 percent in Uttar Pradesh, Himachal Pradesh and Maharashtra, to 5 percent in Andhra Pradesh, and 15 percent in Kashmir and prevalence varies in same region across tribes and caste.
Childlessness: A cause of emotional and psychological distress
- The inability to have children affects couples and causes emotional and psychological distress in both men and women.
- Despite the various social, psychological, economic and physical implications, infertility prevention and care often remain neglected public health issues especially for low-income countries that are already under population pressure.
- But in recent years there is increased awareness to integrate infertility prevention, care and treatment into the basic health care services.
- IVF involves a doctor extracting eggs and fertilizing them in a special lab. Specialists can combine this with an embryo transfer (IVF-ET) and transfer the resulting embryos into a person’s uterus.
- The Society for Assisted Reproductive Technology states that IVF-ET accounts for 99% of ART procedures.
- The Centers for Disease Control and Prevention (CDC) lists the 2018 success rates of IVF treatments for one oocyte retrieval from people using their own eggs as:
- 52% for people aged 35 or younger
- 38.1% for people aged 35–37
- 23.5% for people aged 38–40
- 7.6% for those over the age of 40
Features of the ART Regulation Bill, 2020
(1) Defining ART
- The Bill defines ART to include all techniques that seek to obtain a pregnancy by handling the sperm or the oocytes (immature egg cell) outside the human body and transferring the gamete or the embryo into the reproductive system of a woman.
- Examples of ART services include –
- gamete (sperm or oocyte) donation,
- in-vitro-fertilization (fertilizing an egg in the lab), and
- gestational surrogacy (the child is not biologically related to surrogate mother)
- ART services will be provided through:
- ART clinics, which offer ART related treatments and procedures, and
- ART banks, which store and supply gametes.
(2) Regulation of ART clinics and banks
- The Bill provides that every ART clinic and the bank must be registered under the National Registry of Banks and Clinics of India.
- The National Registry will be established under the Bill and will act as a central database with details of all ART clinics and banks in the country.
- State governments will appoint registration authorities for facilitating the registration process.
- Clinics and banks will be registered only if they adhere to certain standards (specialized manpower, physical infrastructure, and diagnostic facilities).
- The registration will be valid for five years and can be renewed for a further five years. Registration may be cancelled or suspended if the entity contravenes the provisions of the Bill.
(3) Conditions for gamete donation and supply
- Screening of gamete donors, collection and storage of semen, and provision of oocyte donor can only be done by a registered ART bank.
- 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 (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.
- A bank cannot supply gamete of a single donor to more than one commissioning couple (couple seeking services).
(4) Conditions for offering ART services
- ART procedures can only be carried out with the written informed consent of both the party seeking ART services as well as the donor.
- The party seeking ART services will be required to provide insurance coverage in the favor of the oocytes 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.
(5) Rights of a child born through ART
- A child born through ART will be deemed to be a biological child of the commissioning couple and will be entitled to the rights and privileges available to a natural child of the commissioning couple.
- A donor will not have any parental rights over the child.
(6) National and State Boards
- The Bill provides that the National and State Boards for Surrogacy constituted under the Surrogacy (Regulation) Bill, 2019 will act as the National and State Board respectively for the regulation of ART services.
- Key powers and functions of the National Board include:
- advising the central government on ART related policy matters,
- reviewing and monitoring the implementation of the Bill,
- formulating code of conduct and standards for ART clinics and banks, and
- overseeing various bodies to be constituted under the Bill
- The State Boards will coordinate enforcement of the policies and guidelines for ART as per the recommendations, policies, and regulations of the National Board.
(7) Offences and penalties
- Offences under the Bill include:
- abandoning, or exploiting children born through ART,
- selling, purchasing, trading, or importing human embryos or gametes,
- using intermediates to obtain donors,
- exploiting commissioning couple, woman, or the gamete donor in any form, and
- 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.
- Any clinic or bank advertising or offering sex-selective ART will be punishable with imprisonment between five and ten years, or fine between Rs 10 lakh and Rs 25 lakh, or both.
- No court will take cognizance of offences under the Bill, except on a complaint made by the National or State Board or any officer authorized by the Boards.
Need for the ART Regulation Bill
- To regulate and standardize protocols
- There are so many such ART clinics that have been running without regulation and there are implications on the health of those who undertake the procedure.
- Without proper regulation, the unethical practices will increase.
- To Protect Women and Children
- The need to regulate the Assisted Reproductive Technology Services is mainly to protect the affected Women and the Children from exploitation
- The oocyte (a cell in an ovary) donor needs to be supported by an insurance cover. Multiple embryo implantations needs to be regulated and children born through ART need to be protected.
- Overcoming social stigmas: The ART Bill can overcome the social stigma of being childless and respecting the reproductive rights of a woman.
- Increasing popularity of ART technique in India
- India is among countries that have seen the highest growth in the number of ART centers and ART cycles performed every year.
- India has become one of the major centers of the global fertility industry (ART), with reproductive medical tourism becoming a significant activity the need to regulate it is a much needed step.
(1) Excludes single men, cohabiting heterosexual couples, and LGBTQ+ individuals
- The Bill shows progressive attitude by allowing a married heterosexual couples and a woman above the age of marriage to use ARTs however, it excludes single men, cohabiting heterosexual couples and LGBTQ+ individuals and couples from accessing ARTs.
- LGBTQ+ stands for lesbian, gay, bisexual, transgender, queer (or sometimes questioning), and others. The “plus” represents other sexual identities including pansexual, intersex, and asexual.
- The Bill seems to violate:
- Article 14 of the Constitution
- Right to Privacy (In the Puttaswamy case, 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.)
- Court’s direction to the States to take positive steps for equal protection for same-sex couples (Navtej Singh Johar vs Union of India, 2018).
(2) No prohibition on foreign citizens accessing the ARTs: Foreigners can access ART but not Indian citizens in loving relationships. This is an illogical result that fails to reflect the true spirit of the Constitution.
(3) 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.
(4) Little protection for donors
- The Bill does little to protect the egg donor. Harvesting of eggs is an invasive process which, if performed incorrectly, can result in death.
- Need for counseling: The Bill requires an egg donor’s written consent but does not provide for her counseling or the ability to withdraw her consent before or during the procedure.
- Exploitation of women: A woman receives no compensation or reimbursement of expenses for loss of salary, time and effort. Failing to pay for bodily services constitutes unfree labor, which is prohibited by Article 23 of the Constitution.
- Only an insurance policy is not enough: The commissioning parties only need to obtain an insurance policy in her name for medical complications or death with no amount or duration specified.
(5) Ambiguity in disorders
- The Bill requires pre-implantation genetic testing and where the embryo suffers from “pre-existing, heritable, life-threatening or genetic diseases”, it can be donated for research with the commissioning parties’ permission.
- These disorders are not specified and the Bill risks promoting an impermissible programme of eugenics.
- Eugenics is the practice or advocacy of improving the human species by selectively mating people with specific desirable hereditary traits.
(6) Hides information
- Children born from ART do not have the right to know their parentage, which is crucial to their best interests and was protected under previous drafts.
(7) Possible Gamete Shortage
- Gamete shortage is likely to happen as there is no clarity on if gametes could be gifted between known friends and relatives now, which was not allowed earlier.
- Gametes are an organism’s reproductive cells. They are also referred to as sex cells. Female gametes are called ova or egg cells, and male gametes are called sperm.
(8) Poorly Drafted
- Further, Bill’s prohibition on the sale, transfer, or use of gametes and embryos is poorly worded and will confuse foreign and domestic parents relying on donated gametes.
(9) Enhanced Punishments
- The SRB and the Bill impose high sentences (8-12 years) and hefty fines.
- The poor enforcement of the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act, 1994 demonstrates that enhanced punishments do not secure compliance.
ART Bill vs. Surrogacy Bill
- Although the Bill and the SRB regulate ARTs and surrogacy, respectively, there is considerable overlap between both sectors. Yet the Bills do not work in tandem.
- Core ART processes are left undefined; several of these are defined in the SRB but not the Bill. Definitions of commissioning “couple”, “infertility”, “ART clinics” and “banks” need to be synchronized between the Bills.
- A single woman cannot commission surrogacy but can access ART. The Bill designates surrogacy boards under the SRB to function as advisory bodies for ART, which is desirable.
- However, both Bills set up multiple bodies for registration which will result in duplication or worse, lack of regulation, e.g. surrogacy clinic is not required to report surrogacy to National Registry.
- Also, the same offending behaviors under both Bills are punished differently; punishments under the SRB are greater. Offences under the Bill are bailable but not under the SRB.
- ART Regulation Bill 2020 follows the introduction in Parliament of the Surrogacy Regulation Bill 2020, and the approval of the Medical Termination of Pregnancy Amendment Bill 2020. These legislative measures are path breaking steps to protect women’s reproductive rights.
- However, the above mentioned concerns have to be addressed in order to make India an egalitarian society.
- Heterosexual couples and LGBTQI community have fought a long way for recognition of their rights, to give them their equal share of rights is the duty of the law makers in the country.
Try this question for mains:
Q. What is Assisted Reproductive Technology? Discuss the salient features of ART Regulation Bill, 2020?