The passing of the Assisted Reproductive Technology (Regulation) Act, 2021, by an act of

Parliament on December 20, 2021 was a timely step in the right direction.

Durga was the first IVF baby born due to successful efforts of Dr. Subhash Mukhopadhyay in
Kolkata in 1981, but this claim was not recognized by the government due to moral and ethical
reasons. In 1986, Dr. T. C. Anand Kumar and Dr. Indira Hinduja claimed India’s first IVF baby
named Harsha and was accepted by the Indian Council of Medical Research (ICMR).

As defined by WHO, infertility is a complex pathology that requires appropriate investigation and
treatment. One of the most effective treatments is IVF and its related technologies; other
procedures cannot replace these techniques and have resulted in the birth of more than 6
million babies throughout the world. Denying the efficacy and accessibility of these treatments to
infertile couples is not only unethical but is also contrary to the principles of evidence-based
medicine and good medical practice. All treatments known to be safe and effective should be
available to all infertile patients, who should be allowed to make informed reproductive choices
based on sound scientific evidence.

Infertility is a disease of the reproductive system that impairs one of the body's most basic
functions: the conception of children. 8-10 percent affect

Since infertility, subfertility or recurrent spontaneous miscarriage is associated with

chromosomal or genetic anomalies, the confluence of reproductive biology and genetics opened
up the possibility of screening for chromosome and gene defects in the embryo prior to
implantation, leading to the evolution of techniques like preimplantation genetic diagnosis (PGD)
and prenatal testing (PNT). Thus, ART not only serves as a substitute for natural conception in
infertile couples, but can also preempt the birth of a child with inherited genetic disease in
normally fertile ones. In addition, ART also has the potential to help single women and
homosexual couples to have children.2

CHANGES TO CONSIDER

INSURANCE COVER

Section 22. Written informed consent recommends insurance stating “ an insurance coverage of
such amount as may be prescribed for a period of twelve months in favour of the oocyte donor
by the commissioning couple or woman”

insurance coverage for ART treatments remains rare; In a study published in the New England
Journal of Medicine, researchers reviewed national data to examine how a requirement that
insurers provide coverage for IVF affected the outcome of IVF treatments. The underlying
assumption is that the patient's financial burden may lead to a transfer of more embryos to
increase the chances of success in just one cycle.
If patients have no insurance coverage to help with the costs, they may be able to afford only
one or two treatment cycles. If, on the other hand, IVF is covered by an insurance mandate like
those existing in a handful of states, physicians and patients can make decisions that are most
medically appropriate. They can follow, without emotional or financial pressure, the growing
evidence that the transfer of a single embryo, in the right circumstances, results in the birth of a
single, healthy child. (Jain T, Harlow BL, Hornstein MD. Uniform Insurance Coverage and
Outcomes of In Vitro Fertilization. NEJM 2002;347-661-6.)

Important ethical questions also attend many of the social aspects of reproductive health, such
as the issues of hospitals turning away women in labor because they do not have insurance or
of routine four-week waits before women can begin prenatal care.

GUIDELINES SET AS REGULATION TO THIS ACT

COVERING ISSUES IN THE ACT

ANTENATAL AND NEONATAL COMPLICATIONS

The most common complication of ART is the risk of multifetal pregnancies. In 2009, 41.1% of
infants conceived via ART were of multifetal pregnancies (compared to 3.5% of infants in the
general population). [Jain M, Singh M. Assisted Reproductive Technology (ART) Techniques.
[Updated 2023 Jun 7]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing;
2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK576409/ ]
The effort to reduce multifetal gestation via reducing the number of embryos transferred at once
has resulted in a significant reduction—by 2017, 73.6% of ARTconceived infants were from
singleton pregnancies.

Multifetal gestation pregnancies have both maternal and fetal consequences. Pregnancies have
a higher likelihood of being complicated by various antenatal conditions, including hyperemesis
gravidarum, gestational diabetes, and hypertensive diseases of pregnancy. Multifetal gestation
pregnancies also have worse fetal and neonatal outcomes than singleton pregnancies, with a
significant increase in preterm birth and the associated increase in the risk of stillbirth (fivefold)
and neonatal death (sevenfold).

IVF providers limit multifetal gestation pregnancies through several avenues, including lowdose
stimulation regimens, close hormone and follicle monitoring during stimulated cycles, and
limiting the number of embryos transferred per cycle. Once a multifetal gestation is diagnosed,
appropriate counseling regarding the increased risks in pregnancy should be discussed with the
patient, and the option of multifetal reduction, when appropriate, should be offered. Beyond
multifetal gestation, singleton IVF pregnancies are also possibly associated with various
increased risks compared to naturally conceived pregnancies.

Moreover, due to financial constraints, the woman might be able to afford only one more cycle of
treatment, and may hence ask for implantation of all her preserved embryos in order to
maximize her last chance of pregnancy. The resulting multiple pregnancy may culminate in the
birth of extremely premature babies with their own set of problems,11 including the additional
costs of caring for several low birth weight newborns on a long-term basis. But if, to address
this, providers limit the number of embryos that may be implanted at one time, they risk a
surplus that must be disposed of, and reduce the prospects of achieving pregnancies

These risks include perinatal mortality, preterm delivery, low birth weight, cesarean section,
placenta previa, placental abruption, and preeclampsia. These possible risks should also be
discussed when counseling patients, but with caution, as the existing study designs limit the
quality of data. Standardized tracking of outcomes of ART pregnancies to include these
outcomes would improve the quality of evidence for or against these potential risks of
IVF-conceived pregnancies. There is also limited evidence of a low-level increased risk of birth
defects in patients undergoing IVF, particularly with ICSI, though again the quality of evidence is
low. It is reasonable to offer ultrasonographic surveillance during IVF-conceived pregnancies,
such as with fetal echocardiography.

ETHICAL IMPLICATIONS

Research relating to new technologies in the field of reproductive health is important for many
reasons, particularly because such research concerns the creation of the next generation and
because the methods being applied represent a marked break with tradition. Artificial
insemination, in vitro fertilization, and the manipulation of embryos have greatly changed what
was once the private province of two people joined in a socially approved union. Professor
Patricia A. King, of Georgetown University Law Center, has said that the new reproductive
technologies are controversial: because they challenge deeply held moral, ethical, and religious
values, particularly those values that concern the family and relationships among its members.
They involve the deliberate separation of reproduction from the act of human sexuality and from
the human body.

Although very sophisticated techniques are in use at IVF clinics, the success rates for IVF
remain low. Because reproductive research is funded chiefly by major IVF centers,
pharmaceutical companies, and universities, it has been sparse, uneven, and without
established priorities. As a result, there are considerable gaps in our knowledge of the
reproductive process and embryo development.
A better understanding of the basics of reproduction and embryo development not only has the
potential for improving infertility treatments but it also is expected to contribute to many aspects
of reproductive health.

Some of the research questions that remain unanswered are:

How does cryopreservation affect sperm, eggs, and embryos?
What is the optimum number of embryos to transfer during IVF?
Why does development stop in some embryos after a normal beginning? What are the
physiological effects of hormone treatments?
What factors control egg maturation and what factors control implantation?
What are the elements that lead to the natural wastage of eggs and embryos and how do they
operate
Wymelenberg S; Institute of Medicine (US). Science and Babies: Private Decisions, Public
Dilemmas. Washington (DC): National Academies Press (US); 1990. 7, New Technologies: The
Ethical and Social Issues. Available from: https://www.ncbi.nlm.nih.gov/books/NBK235272/

Certain ethical or social issues aroused by some approaches to infertility treatment and by
embryo research focus on research in these areas; other issues are concerned with aspects of
the clinical practice. The latter include concerns about the safety of donated sperm, the
confidentiality of sperm donors, and the right of a child born as the result of donor sperm to
know his or her complete parentage or the genetic/medical aspects of that parentage.
Questions have also been raised about the moral and legal status of early embryos and the fate
of those that are not used in IVF treatment, including frozen embryos. Equally basic are
questions regarding the right of an individual to reproduce; the sale of embryos, eggs, and
sperm; and the pros and cons of defining infertility as a disease, which would affect insurance
coverage

Not surprisingly, analyses of the ethical stances taken by various segments of society reveal a
range of positions concerning embryo research. At one end of the spectrum is the Roman
Catholic Church and other religious groups that believe life begins when the two haploid cells,
the egg and the sperm, unite to form a chromosomally complete cell. The Vatican's Instruction
on Respect for Human Life in Its Origin and on the Dignity of Procreation, issued in 1987,
declares that no moral distinction can be made among any stages of the embryo. According to
this position, the absolute sanctity accorded to human life begins with the fertilized egg, making
it impossible to discard early embryos or to use them for research. At the other end of the
spectrum are those who contend that an embryo is simply a group of living cells and that any
value attached to this biological material is in the eye of the beholder. Those who hold this view
often point out that a large proportion of naturally conceived embryos do not develop after
implantation and that discarding human embryos can be viewed as a similar process.

WALTER BUSHNELL HEALTH CARE FOUNDATION BLAZE VOL 1 NO.7, 2011 - ETHICAL
AND LEGAL ISSUES IN ART

In the past several years, concerns have begun to emerge about the health outcomes of ARTs.
It has been observed that children conceived using ART may be at higher risk of birth defects
and certain genetic anomalies than those conceived naturally. These concerns are aggravated
by the fact that comprehensive safety and efficacy studies were not conducted before adopting
most reproductive technologies into clinical practice [Nelson EL. Legal and Ethical Issues in
ART “Outcomes” Research. Health Law Journal 2005;13:165-186.]

Some critics believe that PGD is 'eugenic' because of its propensity to be abused; it
may enable 'frivolous choices', that is, facilitate the selection of children with certain
desirable physical characteristics or intelligence,5 and eliminate those with a genetic
disorder. [King DS. Preimplantation genetic diagnosis and the new eugenics. J Med
Ethics 1999; 25: 176–182.]

In order to be effective and economical, ART programs often aim for fertilization of more
embryos than will be implanted in women for whose pregnancy the embryos are
created. Disposal of surplus embryos raises legal and ethical concerns.
Non-consensual donation of embryos also raises legal and ethical concerns. Disposal of
embryos is ethically disconcerting, particularly to those who believe that protected
human life commences at conception.

Moreover, due to financial constraints, the woman might be able to afford only one more
cycle of treatment, and may hence ask for implantation of all her preserved embryos in
order to maximize her last chance of pregnancy. The resulting multiple pregnancy may
culminate in the birth of extremely premature babies with their own set of problems,11
including the additional costs of caring for several low birth weight newborns on a
long-term basis. But if, to address this, providers limit the number of embryos that may
be implanted at one time, they risk a surplus that must be disposed of, and reduce the
prospects of achieving pregnancies [Goold I. Should older and postmenopausal women
have access to assisted reproductive technology? Monash Bioeth Rev . 2005
Jan;24(1):27-46.]

LEGAL ISSUES

Parental rights and unmarried women. This issue involves unmarried women who have
used the sperm of a known donor. Here, the donor initiates litigation to establish his
paternity and, thus, his right to visitation.

For instance, when people die before their frozen gametes or embryos have been used,
should a surviving spouse or partner have the right to use the frozen specimens without
the donor's explicit consent?
When a couple freezes their embryos for future use and then divorces, can one partner
use the embryos to have a child over the other partner's objection?
To avoid disputes over frozen gametes and embryos, many authorities suggest that
people should leave written instructions regarding their future disposition wishes.
However, some courts have suggested that, despite such instructions, individuals retain
the right to change their minds at a later date [Assisted Reproductive Technologies -
Legal Considerations. Available at
http://family.jrank.org/pages/114/Assisted-Reproductive-Technolog
ies-Legal-Considerations.html. Accessed on May 12, 2011.]

AGENDA: ETHICAL IMPLICATIONS OF IVF or ASSISTED REPRODUCTIVE

TECHNOLOGIES

Pro-IVF Argument with Case Laws and Precedents:

IVF stands as a symbol of medical progress, inclusivity, and hope. It empowers people by
providing choices and the chance to create families, regardless of the natural barriers they may
face.

1. Infertility Solutions & Right to Parenthood:

IVF provides a vital option for individuals and couples facing infertility, giving them a path to
parenthood that they would not have through natural conception. With infertility affecting millions
worldwide, IVF opens the door to creating families where biological constraints might have
previously been barriers.

In several countries, the right to procreate is considered a fundamental human right. One
prominent example is the European Court of Human Rights (ECHR) case of *Evans v. United
Kingdom (2007) , where the court recognized the right to respect for private and family life
under Article 8 of the European Convention on Human Rights. While the court ruled against the
applicant in this particular case (due to specific circumstances surrounding consent), it
reinforced the idea that reproductive rights fall under the scope of family life protections.

In the U.S. Supreme Court ruling Obergefell v. Hodges (2015), the court established that
same-sex couples have the constitutional right to marry. This ruling also paved the way for
reproductive rights, including IVF and surrogacy for same-sex couples, by legally recognizing
their family structures and giving them equal access to parenthood options. This has led to
broader acceptance of IVF and assisted reproductive technologies (ART) for LGBTQ+
individuals and families.

3. Genetic Screening and Preventing Hereditary Diseases:

4. The progress in reproductive medicine through IVF has allowed for genetic screening, which
can help prevent the transmission of hereditary diseases. This not only improves the health
of future generations but also reduces the emotional and financial burden of managing
genetic disorders.

In the UK case of Warren v. Care Fertility (2014), a couple sued after their embryos were
destroyed by mistake. This case emphasized the importance of regulations and protocols in
fertility clinics but also highlighted that pre-implantation genetic diagnosis (PGD) is an essential
part of IVF treatment to screen for genetic diseases. It reinforced the role of IVF in preventing
hereditary conditions, benefiting not just individuals but society at large by reducing the burden
of genetic disorders.

5. Control Over Timing and Right to Reproductive Autonomy:

IVF allows individuals and couples to take control over their reproductive timing. For those who
face medical issues, career choices, or other life circumstances that affect when they can start a
family, IVF provides a way to plan more precisely, increasing their chances of success when
they are ready.

In Artavia Murillo et al. v. Costa Rica (2012), the Inter-American Court of Human Rights ruled
that Costa Rica’s ban on IVF violated the right to personal autonomy and reproductive rights.
The court emphasized that individuals have the right to decide the timing and manner of
reproduction, affirming IVF as a legitimate means of exercising reproductive autonomy

Pros

Fallopian Tubes Not Necessary

A woman’s fallopian tubes may become blocked due to a previous pelvic infection such as
appendicitis or chlamydia. Once it has been determined that the fallopian tubes are blocked, IVF
is the only possible treatment when attempting to conceive. IUI is not a viable option because it
requires open and working fallopian tubes, allowing a fertilized egg to travel from the tube into
the uterus where it may implant. IVF does not require the fallopian tubes to be present as it
takes the eggs from the ovaries and implants the embryo directly into the uterus.

Low Sperm Count

If the quality of the man’s sperm or the sperm count is an issue, IUI is not a suitable option in
most cases. IVF is a good option because it injects the sperm directly into the egg by ICSI
(Intracytoplasmic Injection of the sperm into the egg), which facilitates successful fertilization of
an egg.

Lowered Chance of Abnormality

Some couples may be at high risk of conceiving a baby with an abnormality. With the use of IVF,
however, embryos can be tested before they are implanted in the uterus. This helps reduce the
risk of the baby developing with a condition that either partner, or both, carries a gene for.