Regulating ART and Surrogacy: Associated Challenges – Explained, pointwise

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India’s fertility industry has a potential market of US $12 billion. In 2021, the Parliament enacted the Assisted Reproductive Technology (Regulation) Act that seeks to monitor and regulate Assisted Reproductive Technologies (ART) and surrogacy. While many welcome it as a step in the right direction, they also fear that the new laws leave no incentive for surrogates and donors, thus opening the scope for black-marketeering.

What is Assisted Reproductive Technology (ART) and Surrogacy?

The Act defines Assisted Reproductive Technology (ART) as all techniques that attempt to obtain a pregnancy by handling reproductive cells (sperm or oocyte) outside the body and transferring the gamete or the embryo into the reproductive system of a woman.

According to the Centers for Disease Control and Prevention (CDC) of the US, ART procedures involve surgically removing eggs from a woman’s ovaries, combining them with sperm in the laboratory, and returning them to the woman’s body or donating them to another woman.

Examples of ART services include gamete (sperm or oocyte) donation, in-vitro-fertilisation (fertilising an egg in the lab) and gestational surrogacy (the child is not biologically related to the surrogate mother).

Surrogacy is an arrangement where a woman bears a child for another couple or person with the intention of handing over the child to them after birth.

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What is the progress of ART and Surrogacy legislation in India?

The Surrogacy (Regulation) Bill (SRB) 2016 was introduced to place a ban on commercial surrogacy and allow only altruistic surrogacy. The updated version, SRB 2019—passed by Lok Sabha in August 2019, was referred to a Select Committee.

The Committee recommended that the ART Bill to be brought first so that all the technical aspects could comprehensively be addressed by the bill. Accordingly, the government framed the ART (Regulation) Bill, 2021.

However, before the passage of the ART (Regulation) Act and the Surrogacy (Regulation) Act, 2021; India did not have any statutory laws regulating ART and surrogacy. The only guidelines available were the ones issued by the Indian Council of Medical Research (ICMR) in 2005.

Note: According to an Ernst & Young study, about 10-15% of all Indian couples are unable to conceive by natural means. The study also estimated that only 1% of them seek infertility evaluation. High costs seem to be a factor—an IVF cycle roughly costs ₹1.5-2 lakh. Besides, the chances of an IVF cycle leading to pregnancy is only 50-60%.
What are the salient provisions of the ART Act and Surrogacy Act?

The ART Act outlaws the sale of gametes (unfertilized egg and sperm), zygotes (a single cell organism resulting from a fertilized egg) and embryos (the early development stage of a human). The Act also allows insurance coverage for donors.

The Surrogacy Act permits only altruistic surrogacy. Surrogacy is permitted only for intending couples who suffer from proven infertility or for any condition or disease specified through regulations. Surrogacy is not allowed for commercial purposes or for producing children for sale, prostitution or other forms of exploitation.

The ART Act also impose fines of ₹5-10 lakh and imprisonment of 5-10 years in case medical practitioners and clinics are caught engaging in commercial surrogacy and abandonment of the child born through ART or surrogacy procedures, among others. These offences have been made bailable and cognizable, which means a warrant is not required to start the investigation or arrest the person.

Read more: Lok Sabha passes Surrogacy (Regulation) Bill
Why is there a need to regulate surrogacy and ART?

First, Growth of ART: A market projection (by Fortune Business Insights) has noted that the size of the ART market is expected to reach US$45 billion by 2026. Among Asian countries, India’s ART market is pegged at third position.

The number of ART clinics in the country is likely more than 40,000, as per the Ministry of Health and Family Welfare. But only about 1,850 clinics and banks are either enrolled or identified with ICMR. This has led to a plethora of legal, social and ethical issues.

Second, prevent the exploitation of patients: The Acts have provisions to protect the rights of the donors, the commissioning couple and the children born out of ART and surrogacy. So, it will be impossible for outlaws to operate within the system and exploit patients to make huge profits.

Third, Creation of database: Without registration and a proper database of medical institutions and clinics providing ART services, it is impossible to regulate services like surrogacy and Medical Termination of Pregnancy. Hence, both the Acts facilitate proper registration.

Fourth, the Supreme Court in the Baby Manji Yamada vs Union of India case, 2018, prompted the Government to pass the Act to regulate surrogacy and ART. The Court recognized the legal status of “commercial” surrogacy and ruled that the intending parent may also be a single man or homosexual couple.

Read more: Lok Sabha passes Bill to regulate assisted reproductive technology
What are the challenges associated with regulating ART and surrogacy?

Challenges to perform ART:  Permitting only insurance and outlawing the sale of gametes and embryos have few challenges,

a) Out of the total cost of ₹80,000 incurred on egg donation, a gamete donor usually receives ₹40,000-50,000 as compensation. By outlawing the sale, the donors might not donate at all. b) Poor women may still enter into illegal transactions but will have no legal recourse in case of any medical or other complications and push the practice to the underground and black market.

Scientifically impossible provisions: The new ART law allows retrieval of not more than seven oocytes from a single donor. A woman typically produces several oocytes in a reproductive cycle, but only one oocyte matures to form an ovum. But, It’s clinically impossible to ensure the number of eggs a woman can produce. Further, eggs produced cannot be left behind in the body as it is risky.

A good donor produces 10-18 eggs. At 18 eggs, there are higher chances of pregnancy during the same IVF cycle. If the number of eggs to be retrieved are capped, there will be requirement of multiple cycles or donor stimulations, which will increase the cost for intending couples.

Increase the cost of ART: The current law restricts the gametes of one donor to be used by only one commissioning couple or woman. Two intending couples sometimes share donated gametes from the same donor to bring down the cost. Restricting the sharing will further increase the costs.

Limit ART’s to large cities: The new laws mandate both clinics and banks to ensure the eligibility of intending couples and donors. Only banks are allowed to do screening of donors and retrieve eggs. There are ART clinics in small towns where maintaining banks is not feasible because of economies of scale. If screening or retrieving eggs is limited only to Banks, frozen eggs will have to be transferred to clinics from banks which is not as effective as fresh eggs.

Challenges in responsibility: The law holds medical practitioners and clinics responsible for the abandonment of children born through ART or surrogacy procedure. For instance, If a child is abandoned because of discord between the parents, the medical practitioners and clinics are responsible even though the clinic take proper consent from the couples. This will act as deterrent to clinics.

Ban on commercial surrogacy and associated issues: An entire village in Gujarat’s Anand district improved its economic status using commercial surrogacy as an option. As the business of commercial surrogacy flourished, Gujarat’s milk capital earned the additional title of being a “baby factory”.

With the new law in place, similar hospitals and potential surrogates will have to look for new means of livelihood.

Read more: Significance of Assisted Reproductive Technology Regulation Bill
What should be done to improve ART and surrogacy in India?

Follow the international practices: Countries like the UK, South Africa, Greece and Netherlands allow only altruistic surrogacy, but the eligibility for being a surrogate mother is far relaxed in these countries. They have no such requirement for women being married, and no restrictions on the number of times women can be a surrogate.

The current ICMR guidelines, prepared after a lot of research, allow donations up to six times. So, India must follow similar norms.

Regulating commercial surrogacy would have been a better alternative than banning it. Rather than penalising surrogacy, the person providing a womb for surrogacy must be secured with a contract, ensuring proper, insurance and medical checks.

Make the Act inclusive: LGBTQIA+ and single men can also be included into the ambit. Further, the ART service providers have to form inbuilt ethics committees and mandated counselling services within their facility.

Source: Mint

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