India’s new laws take a toll on Fertility Inc.

But within a few hours Sherpa’s condition deteriorated. She stopped responding to verbal commands, although ultrasound sonography did not detect external or internal bleeding. He was shifted to another private hospital with ICU facility. The hospital kept on record that the patient was already in a critical condition when he was taken at 11 pm. Yuma Sherpa was pronounced dead in less than an hour.

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

But for India’s fertility industry which is a potentially $12 billion market, the law may well be a case for throwing the proverbial baby out with the bathwater. While many welcome this as a step in the right direction, they fear the new laws leave no incentive for surrogates and donors thus opening up scope for black marketing. Furthermore, stricter regulations may well propel the thriving ART industry under the table.

Experts pointed out that Sherpa’s death, widely regarded as a clear example of the dangers posed by an unregulated industry, cannot be held at the doorstep of the medical fraternity—the Delhi Medical Council’s inquiry ultimately led to the doctors’ Any medical negligence on the part rejected. , The matter was brought to the council by Sarojini N of Sama Resource Group for Women and Health, who alleged that the IVF clinic did not provide adequate care despite Sherpa’s complaints that the medicine “did not suit her”.

The council found that Sherpa was a rare complication of ovarian hyperstimulation syndrome during the IVF procedure, which can be fatal in one in 4-5 lakh cases. The only punishment that got in the way of the IVF clinic was the warnings issued for indulging the agents into patients.

laws for reproduction

According to a study by Ernst & Young, around 10-15% of all Indian couples are unable to conceive by natural means, which is estimated that only 1% of them seek infertility evaluation. High cost appears to be a factor – an IVF cycle costs approx. 1.5-2 lakhs. Also, IVF cycle has only 50-60% chance of conceiving.

ART, a broad category to which IVF falls, represents all techniques for achieving pregnancy by handling reproductive cells outside the body and transferring them or embryos into a woman’s reproductive system. Surrogacy is an arrangement where a woman gives birth to a child for another couple or individual with the intention of handing over the child to them after birth.

As of December 2021, there was no statutory law in India regulating ART and surrogacy, a laxity that gave rise to a kind of industry closely associated with medical tourism. The only guidelines to follow were issued by the Indian Council of Medical Research (ICMR) in 2005.

But in 2008, the Supreme Court took some important decisions in Baby Manji Yamada v Union of India, forcing the government to draft a bill to regulate surrogacy and ART. The court recognized the legal status of “commercial” surrogacy, and ruled that the intended parents may also be single males or homosexual couples. A woman who wishes to become a parent may be healthy and fertile but is not willing to undergo pregnancy, the court said. “If you read the judgment, it is quite open and progressive,” said Radhika Thapar Behl, founder of Fertility Law Care (FLC).

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

A year later, the Surrogacy (Regulation) Bill (SRB) 2016 was introduced in the Lok Sabha to ban commercial surrogacy. From now on only altruistic surrogacy will be allowed and only medical expenses or other fixed expenses can be paid to surrogate mothers. The updated version, SRB 2019 – was passed by the Lok Sabha in August 2019, referred to a selection committee, which recommended that an ART Bill be brought in first so that all technical aspects are comprehensively addressed by SRB 2019 Can go Light was seen in that ART bill. of the day in December 2019.

Behl of the FLC agreed that commercial surrogacy is degraded around the world. “But there are provisions for fair compensation for the surrogate,” she said. Countries such as the UK, South Africa, Greece and the Netherlands also allow only altruistic surrogacy, but in these countries the eligibility to be a surrogate mother is very low, regardless of whether she has been married and how many times she can be a surrogate. There is no restriction on this.

money vs morality

The tone and tone of the debate that preceded the two bills in the Lok Sabha last December echoed counterarguments for those in favor of a more liberal ART/surrogacy policy. MP and Trinamool Congress women’s wing chief Kakoli Ghosh Dastidar sheds light on the case of a doctor from Gujarat who took eggs from poor women across villages or used them as surrogates in exchange for food. Lawmakers from all parties unanimously supported the ban on commercial surrogacy.

Dastidar did not name the doctor concerned, but the city in Gujarat she was referring to was Anand, where commercial surrogacy had become an almost acceptable means of livelihood. Hansa Ben will attest to this. Already a surrogate mother twice, the 52-year-old said she delivered via an operation (C-section) but without any complications. “For the first time, it was in 2007 for an African (Afro-American) couple from the United States, and then it was for a Japanese couple,” she said. Ben has received 5 lakh every time and get compensation of approx. 10,000 every year on the birthdays of the children born to him. With that money, Ben built a house and paid for his son’s school fees.

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

Dr Niket Patel, Medical Director of Akanksha Hospital, agreed that most women who visit her hospital for surrogacy do so for reasons of money. “Many women in the past have done well for themselves,” he said. With the new law, such hospitals and potential surrogates will have to look for new means of livelihood.

“These two laws are a welcome move overall, but effectively banning commercial surrogacy would be a better option,” Patel said.

While the new surrogacy law outright bans commercial surrogacy, its ART allows the sale of twin gametes (unfertilized eggs and sperm), zygotes (a single-celled organism produced from a fertilized egg) and embryos (early developmental stages of a human). make illegal. It is difficult for egg donors to get compensation through legal means.

out of the total cost of 80,000 spent 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 are in exchange for money. The new law allows insurance coverage for donors only. Who will donate in such a situation?” Kumar asked.

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 can still enter into illegal transactions, but in case of any medical or other complications. They will have no legal recourse.

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

A helping hand or a heavy hand?

The new ART law does not allow the retrieval of more than seven oocytes from a single donor. A female usually produces several oocytes in one reproductive cycle, but only one oocyte matures to form an ovum.

“It is medically impossible to know for sure how many eggs a woman can lay. Furthermore, the eggs produced cannot be left behind in the body as it is risky,” said Dr. Himanshu Bavishi, founding director of the Bavishi Fertility Institute. This clause has persisted since the earlier draft, perhaps because of the statement that women are being made to be more aroused and that gametes are being shared by multiple recipients. This could have been managed by setting an upper limit on the dose of injection and the number of recipients.

“A good donor is one who lays 10-18 eggs. At 18 eggs, your chances of conceiving during the same IVF cycle are very high. If you limit the number of eggs that can be obtained, you will have to undergo multiple cycles or donor stimulation, which will increase the cost for interested couples,” Dr Niket Patel said.

Current law restricts a donor’s gametes to be used only by a commissioning couple or female. Two pairs sometimes share gametes from the same donor to reduce costs.

The main argument against allowing multiple couples to share gametes: such children—theoretically—might end up as partners in the future. “But if only oocytes are shared, not the whole embryo, it is not such a big issue as it is just half the DNA content,” said Dr Gayatri Kar Soni, infertility specialist at Batra Hospital in Delhi.

As per the new laws, a woman can donate her eggs only once in her life or can opt for surrogacy. “The current ICMR guidelines, prepared after much research, allow donations up to six times. It is followed internationally as well,” said Dr Shivani Sachdev Gaur, Director, SCI IVF Center in Delhi.

Difference

According to the Ministry of Health and Family Welfare, the number of ART clinics in the country is likely to exceed 40,000. But around 1,850 clinics and banks are either enrolled or identified with ICMR. New laws mandate both clinics and banks to ensure the eligibility of willing couples and donors. Only banks are allowed to screen donors and receive eggs.

Dr Bavishi said that this is another hurdle. “There are ART clinics in small towns where it is not possible to maintain banks due to economies of scale. Clinics should be allowed to test donors or receive eggs—frozen eggs have to be transported to remote areas and are not as effective as fresh eggs,” he said.

Current laws also impose fines 5-10 lakhs and 5-10 years imprisonment in case the doctors and clinics are found to be involved in commercial surrogacy and abandon the child born through ART or surrogacy procedures, among others. These offenses have been made bailable and cognizable, which means that no warrant is required to initiate an investigation or arrest the person.

“You take proper consent, advise the couple, but tomorrow if the child is abandoned due to discord between the parents, how can the doctor be held responsible?” Dr Bavishi wondered. Only gender-selection and practice with blatant negligence should be kept cognizant, he said.