India’s new laws land heavy on fertility Inc.

But within hours, Sherpa’s condition took a turn for the worse. She stopped responding to verbal commands although ultrasound sonography did not reveal any external or internal bleeding. She was taken to another private hospital with ICU facility. The hospital put it on record that the patient was already in a critical condition when taken in at 11 pm. In a little over an hour’s time, Yuma Sherpa was declared dead.

Eight years later, as India finally came out with a set of laws that seeks to monitor and regulate surrogacy and assisted reproductive technologies (ART), Yuma Sherpa was not forgotten. Union health minister Mansukh Mandaviya mentioned Sherpa’s case (without naming her though) during his concluding statements in Rajya Sabha as the two landmark bills were passed last December.

But for India’s fertility industry that is a potential $12 billion market, the laws might well be a case of throwing the proverbial baby out with the bath water. While many welcome it as a step in the right direction, they fear that the new laws leave no incentive for surrogates and donors thus opening the scope for black-marketeering. Besides, the harsh regulations could well push the booming ART industry under the table.

Experts pointed out that even Sherpa’s death, widely perceived as a glaring example of the dangers posed by an unregulated industry, cannot be laid at the door of the medical fraternity—a Delhi Medical Council probe eventually ruled out any medical negligence on part of the doctors. The case was brought to the council by Sarojini N. from Sama Resource Group for Women and Health who alleged that the IVF clinic did not provide adequate care for Sherpa despite her complaints that the medication was not “suiting her”.

The Council found that Sherpa’s was a rare complication of ovarian hyperstimulation syndrome during an IVF procedure, which could be fatal in one out of 4-5 lakh cases. The only punishment that came the way of the IVF clinic was a warning issued for engaging agents to rope in patients.

Laws for Reproduction

About 10-15% of all Indian couples are unable to conceive by natural means, according to an Ernst & Young study, which estimates 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%.

ART, the broad category that IVF falls under, represents all techniques to obtain pregnancy by handling reproductive cells outside the body and transferring them or the embryo into a woman’s reproductive system. 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.

Until December 2021, India did not have any statutory laws regulating ART and surrogacy, a laxity that had spawned an industry of sorts that tied along well with medical tourism. The only guidelines to go were the ones issued by the Indian Council of Medical Research (ICMR) in 2005.

But in 2008, the Supreme Court made some important decisions in the Baby Manji Yamada vs Union of India case, prompting the government to draft a bill 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. A female wanting to be a parent may be healthy and fertile but unwilling to undergo pregnancy, the court said. “If you read the judgment, it’s pretty open and progressive,” said Radhika Thapar Bahl, founder of Fertility Law Care (FLC), which acts as legal advisor to doctors, patients, ART Banks/surrogates/donors associated with fertility.

In January 2015, a lawyer, Jayashree Wad, approached the apex court seeking a ban on commercial and transnational surrogacy citing exploitation of surrogates. “This petition created an impression that a lot of foreigners come to India and take away babies,” said Bahl. Before independent stakeholders could be heard in the court, the government issued a notification ending transnational surrogacy.

A year later, the Surrogacy (Regulation) Bill (SRB) 2016 was introduced in the Lok Sabha to place a ban on commercial surrogacy. Henceforth only altruistic surrogacy would be allowed and surrogate mothers could be paid only the medical expenses or other prescribed expenses. The updated version, SRB 2019—passed by Lok Sabha in August 2019, was referred to a Select Committee, which recommended that an ART Bill be brought first so that all the technical aspects could comprehensively be addressed by SRB 2019. That ART bill saw light of the day in December 2019.

FLC’s Bahl agreed that commercial surrogacy is looked down across the world. “But there are provisions of reasonable compensation for surrogates,” she said. Countries like the UK, South Africa, Greece and Netherlands too allow only altruistic surrogacy, but the eligibility for being a surrogate mother is far relaxed in these countries, with no requirement for her being married and no restrictions on the number of times she can be a surrogate.

Money Vs Morals

The tone and tenor of the debate in Lok Sabha that preceded the two bills last December summed up the counter argument for those in favour of a more lenient ART/surrogacy policy. Kakoli Ghosh Dastidar, MP and women’s wing chief of Trinamool Congress, highlighted the case of a doctor from Gujarat who used to take ovum from poor women of an entire village or use them as surrogates in exchange for food. MPs across party lines unanimously supported the ban on commercial surrogacy.

Dastidar didn’t take the name of the doctor concerned, but the town in Gujarat she was referring to was Anand where commercial surrogacy had become an almost acceptable means of livelihood. Hansa Ben would certify that. Already a surrogate mother twice, the 52-year-old said she delivered through an operation (C-section) but with no complications. “First time, it was for an African (Afro-American) couple from USA in 2007, and then it was for a Japanese couple,” she said. Ben received 5 lakh each time and gets a compensation of around 10,000 every year on the birthdays of the children she bore. With that money Ben built a house and paid for her son’s school fee.

Ben recommended a dozen women to Akanksha Hospital in Anand, all of whom later became surrogate mothers. As the business of commercial surrogacy flourished at the hospital, Gujarat’s milk capital earned the additional title of being a “baby factory”.

Dr Niket Patel, medical director at Akanksha Hospital, agreed that most women who approach his hospital for surrogacy do so for monetary reasons. “A number of women who have been surrogates in the past have done well for themselves,” he said. With the new law in place, such hospitals and potential surrogates will have to look for new means of livelihood.

“These two laws overall are a welcome step, but regulating commercial surrogacy would have been a better alternative than effectively banning it,” Dr Patel said.

While the new surrogacy law bans commercial surrogacy altogether, its ART twin 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), making it difficult for egg donors to be compensated through legal means.

Out of the total cost of 80,000 incurred on egg donation, a gamete donor usually receives 40,000-50,000 as compensation, said Saurabh Kumar who runs Fertility Care India ART Services in Delhi. “All voluntary donations happen in return for money. The new law only allows insurance coverage for donors. Who will donate under such a condition?” asked Kumar.

Prabha Kotiswaran, professor of law and social justice at King’s College London, echoed Kumar’s concerns when she said that despite these laws, poor women may still enter into illegal transactions but will have no legal recourse in case of any medical or other complications.

“The effective ban is arbitrary and will only push the practice to underground and black markets,” she said.

Helping Hand or Heavy Hand?

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.

“It’s clinically impossible to ensure the number of eggs a woman can produce. Besides, eggs produced cannot be left behind in the body as it is risky,” said Dr Himanshu Bavishi, founder director of Bavishi Fertility Institute. This clause has persisted since the earlier drafts perhaps because of a deposition that women are being made to overstimulate and gametes are being shared by multiple recipients, he added. This could have been managed by setting an upper limit on the dose of injections and number of recipients.

“A good donor is someone who produces 10-18 eggs. At 18 eggs, your chances of pregnancy during the same IVF cycle are very high. If you cap the number of eggs to be retrieved, you will have to go through multiple cycles or donor stimulations, which will increase the cost for intending couples,” said Dr Niket Patel.

The current law restricts gametes of one donor to be used by only one commissioning couple or woman. Two couple sometimes share gametes from the same donor to bring down the cost.

The main argument against allowing multiple couples sharing gametes: such children could—theoretically— end up as partners in the future. “But if only oocytes are shared, not the entire embryo, it’s not that big an issue as that’s just half the DNA material,” said Dr Gayatri Kar Soni, an infertility specialist at Batra Hospital in Delhi.

A woman can donate her eggs or opt for surrogacy only once in her lifetime, as per the new laws. “The current ICMR guidelines, prepared after a lot of research, allow donation up to six times. This is followed internationally as well,” said Dr Shivani Sachdev Gour, director at SCI IVF Centre in Delhi.

The Contraindications

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. The new laws mandate both clinics and banks to ensure eligibility of intending couples and donors. Only banks are allowed to do screening of donors and retrieve eggs.

Dr Bavishi said this poses another hurdle. “There are ART clinics in small towns where maintaining banks is not feasible because of economies of scale. Clinics should be allowed to screen donors or retrieve eggs— frozen eggs would have to be transported to remote areas and are not as effective as fresh eggs,” he said.

The current laws 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.

“You take proper consent, counsel the couple, but tomorrow if the child is abandoned because of discord between the parents, how could a doctor be held responsible?” wondered Dr Bavishi. Only practices to do with sex-selection and gross negligence should be kept cognizable, he added.

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