In the name of fertility

On June 2, 2022, a 16-year-old girl walked into the Erode South police station to file a complaint. Her narration of the ordeal she was put through since 2017 went on to kick up a storm in the infertility treatment sector in Tamil Nadu. In four years, she was forced to sell her oocytes eight times to various Assisted Reproductive Technology (ART) clinics in Erode, Perundurai, Salem and Hosur with a forged Aadhaar card. She had also been raped multiple times, she said.

The girl’s complaint led investigators to an illegal sale of oocytes for fertility treatments involving hospitals not just in the western belt but as far as Tirupati and Thiruvananthapuram. Four persons, including her mother, are behind bars now. In her complaint, the girl, a Class VIII dropout, said her mother separated from her father when she was three years old and had since been living with A. Syed Ali, 40. She said that after she attained puberty at 12, she was sexually assaulted by Syed Ali in the presence of her mother.

The ordeal did not stop there. The minor girl was taken to hospitals in Erode, Perundurai, Salem and Hosur, where her oocytes were sold eight times since 2017. Her mother and Syed Ali received ₹20,000 for each visit to hospital, while intermediary K. Malathi, 36, received ₹5,000 in commission. Since she was a minor, an Aadhaar card with a different name and address and her date of birth as 1995 was forged for the purpose. A. John, 25, a van driver, prepared the fake Aadhaar card, which was used to commit the offence in hospitals.

The girl said her mother and Syed Ali threatened her not to disclose it to anyone, and she was subjected to frequent sexual assault. In an attempt to escape, the girl left for her friend’s house in Salem on April 25 and lived there for three days. But her mother and Syed Ali came there and forced her to go with them to a hospital. She refused and alerted her relatives, who took her from her friend’s house and approached the police. A case was registered under Sections 5(l), (m), (n) r/w 6, 16 r/w 17 of the Protection of Children from Sexual Offences (POCSO) Act, 2012, Sections 420, 464, 41, 506 (ii) of the Indian Penal Code and Sections 34 and 35 of The Aadhaar (Targeted Delivery of Financial and Other Subsidies, Benefits and Services) Act, 2016, and all the four were arrested and lodged in prisons.

A team, led by Additional Superintendent of Police (ADSP) Kanageswari, began inquiries with doctors and staff of two hospitals in the district. Also, documents related to the girl’s admission and discharge, proof of identity submitted by the girl’s mother and medical records related to oocyte donations in the past years were verified. The police are now probing whether Malathi had acted as an intermediary for any women in selling oocytes illegally. The city houses over 10 in-vitro fertilisation (IVF) centres and based on investigations, the role of intermediaries and of hospital staff would be examined, sources said.

Likewise, a six-member team, led by A. Viswanathan, Joint Director of Medical and Rural Health Services, Directorate of Medical and Rural Health Services (DMS), held an inquiry with the victim at the government home in Erode for three hours and recorded her statement. The team visited four hospitals, verified records and held inquiries with the staff.

Dr. Viswanathan told media persons that the girl was also taken to hospitals at Tirupati and Thiruvananthapuram for selling her oocytes and added that they would soon visit these hospitals too.

While a detailed probe is under way, the case has re-ignited debates on the need for regulations and stricter monitoring of fertility services and its various processes in the State. This is where two new Acts — The Assisted Reproductive Technologies (Regulation) Act and the Surrogacy (Regulation) Act — passed in December 2021, have become relevant.

For a State like Tamil Nadu that continues to see routine violations under the Pre-Conception and Pre-Natal Diagnostic Techniques Act, 1994, implementation of the two laws to regulate a booming fertility sector could be no less than a challenge. Officials noted that every year, at least 10 to 15 cases of illegal sex determination are registered in the State as they keenly watch the districts with a low sex ratio.

The State has nearly 200 registered ART clinics. Though the new laws have sparked debates, a cross-section of specialists is of the view that it would certainly address the need for a regulatory mechanism for fertility services, while raising crucial areas of concerns. The laws have done away with commercial surrogacy, mandate insurance coverage for surrogate mothers and oocyte donors instead of remuneration, allow women to donate oocytes only once in their lifetime and have laid down clear definitions for intending couples/single woman, donors and surrogates.

Need for regulation

Priya Kannan, embryologist, Garbba Rakshambigai Fertility Centre, pointed out that before the two new laws, ART clinics were following guidelines laid down by the Indian Council of Medical Research.

“The ART Act is quite a strict law. It has outlined regulations on who can start IVF centres, personnel, qualification and experience, basic regulations and mandatory facilities required. Some aspects were impractical. So, we, through the association, held dialogues with the government to bring in changes in the interest of patients. They have not budged on certain things, such as single-time donors, the number of eggs to be retrieved and altruistic surrogacy,” she said.

The law states that an oocyte donor can donate only once in her lifetime, and the age has been raised from 21 to 23, she noted.

“In the Erode incident, there is no way a hospital can find out if the Aadhaar card was forged and how many times a donor has donated oocytes when the law mandates that the donor should be married, aged above 23 years, can donate only once in a lifetime with the mandatory consent from the partner,” Dr. Kannan said.

Priya Selvaraj, fertility expert and associate director of GG Hospital, pointed out that this incident not only highlighted the fact that crucial government documents for identity proof can be tampered with in order to enable a minor to be violated, but also lapses in smelling a scam if the same girl is brought for egg donation repeatedly, without supporting documentation of being married/single/divorced or mother of at least one child.

“If so, what is the proof of it? Yes, maybe a family can fool hospitals or organisations once or twice, but if repeated and with no documentation, then it amounts to negligence. How sure can we be when couples show up looking much older than their documented age but providing Aadhaar card as proof? So here the hospital, doctors and the patients all become victims of a collective fraud. All the more why regulations are strongly enforced,” she said.

K.S. Jeyarani Kamaraj, director and senior consultant, Aakash Fertility Centre and Hospital, said ART definitely needed a law. “Being in the field of ART for the past 30 years, we were in need of legislation that could streamline the processes. The new laws have clear-cut norms in terms of egg donations and surrogacy, and could prevent exploitation of women. Yet, there may be practical difficulties when it comes to implementation,” she said.

Challenges and concerns

So, here are the key concerns. As Dr. Selvaraj stated: “The laws are very welcome and a huge necessity to curb unethical practices and prevent violation of both intending parents and third party reproduction. Alongside, the law enforcement authorities must also understand why women in our country would come forward as egg donors or surrogates. One can expect altruism from blood relatives or close friends, but not from unrelated sources. The idea of giving insurance coverage, and not an actual monetary compensation, may in the future open up other avenues of donor compensation unknown to law. Even though we give a coverage amounting to a year to three years, how many of them will actually need it is unpredictable.”

How altruism will work in surrogacy is something that doctors are concerned about. “We do not know how the actual flow of events will be. Some of the ART clinics stopped the surrogacy programme in January after they were through with the existing patients. They have stopped recruiting surrogates. How a surrogate mother will benefit from an insurance product is not clear,” Dr. Kannan said.

Dr. Jeyarani wondered that while remuneration for oocyte donors and surrogate mothers should be through insurance coverage, the amount and its execution were not specified. “This could lead to a hike in the cost of the donor programme.”

A specialist said it was usually women from the poor economic strata who donate eggs or volunteer to be a surrogate. “By donating eggs, she might get ₹30,000 to ₹40,000 and ₹4 lakh to ₹4.5 lakh if she is a surrogate mother. So far, we are providing honorarium for the services rendered by her. It will be unfair if she does not get the promised money and undergoes pregnancy.”

The matter, Dr. Selvaraj said, would be greatly settled if the government set a uniform compensation rate for both egg donors and surrogates so that more women would be encouraged to come forward, and would also be benefited.

That clinics had to stop recruiting surrogates has had its own impact. “Well, when we need to bring laws, one has to stop surrogacy. We were given a time period to complete deliveries. Time may be lost as the couples and recruited surrogates will have to wait and go through the formalities under the guidelines established. However, that is inevitable for any regulations. Each State is forming its committees at different paces and so there is delay in treatment for the couples who genuinely require them,” she added.

Retrieval of a specified number of oocytes is another issue. With the law stipulating that only seven oocytes be retrieved, Dr. Kannan said, “Once stimulation is done, the number of eggs retrieved is not entirely under our control. When this was raised, we were told that the unused eggs should be frozen for the use of the same patient.” Dr. Selvaraj is of the view that it is medically impossible to control the number of eggs retrieved even with a minimal stimulation, and sometimes the required number may not be met. “The magic number for achieving one pregnancy from eggs is projected as 10-15, then how can one restrict? However, one can allow embryos to be frozen for the same couple. The ART centres should have the required facilities to manage cases of hyperstimulation syndrome or at least refer in time to another tertiary care centre. It is manageable when treatment protocols are in place. If minor changes in the laws governing third-party reproduction are made, we will be set to treat many helpless couples,” she added.

“Once ART banks are in place, perhaps with the new registration system, a donor can be tracked if they venture to donate more than once. Ideally, allowing them two times would be beneficial,” she observed.

Dr. Kannan hoped that certain aspects would change. “We have to source all egg donors through the ART bank. So, the onus is on the bank to screen donors. We are hoping that an integrated system is put in place. The proposed ART bank will help in better compliance with the laws. Once such a supply is established, it is safe for clinics as well,” she noted. The creation of a database of donors at the banks would benefit in more than one way. “Being the end-users, we also have the responsibility of verifying the details of donors. So, a two-step scrutiny will come into place. This, in turn, will be more protective for doctors,” she said. “Nobody wants to be on the wrong side of the law,” she added.

There has been a lot of debate on the registration fees for induction of new clinics/hospitals but then the government did reduce the amount, Dr. Selvaraj said, adding: “Apart from that, the fact that we will need separate ART clinics/banks and surrogacy clinics registration — under different consultants — is making it a bit complicated. Instead, perhaps allowing well-established fertility centres/hospitals to function as all three, post-inspection, will be ideal. Licence can be issued after inspection. It is mandatory that we bring in regulations. Collectively, we have all sent in our requests for subtle changes that were directed towards certain medical processes, qualifications and as well as third-party reproduction becoming altruistic.”

With the law mandating one donor-one recipient and prohibiting sharing of donated oocytes, another question raised by Dr. Jeyarani is how the embryos should be disposed of. “It can be used only for research purposes. This will raise the burden on us.”

There are certain needs as well. “Infertility is at the rate of 15% in the Indian population. ART procedures are not indicated for all the affected couples. Take a number, for instance. Of 100 couples, only 27% to 28% need ART procedures. Other causes can be treated with medications and simple surgical procedures. We need to identify those who are in real need of ART. There is a lack of advanced training courses and expertise. So, recognised advanced courses should be brought to improve the skills of young upcoming specialists in fertility medicine,” she said.

Lack of insurance coverage for ART treatment is another issue. “We want fertility procedures to be covered under insurance schemes. This should be treated as a disease but insurance companies do not consider infertility for coverage as they feel it is not a life-saving procedure. But for a couple with infertility, this is more than a disease that affects their mental, physical and social well-being and even disrupts their marital life. So, the government should take measures to bring fertility treatment under insurance coverage,” she suggested.

Realising the need to cater to the growing demand for fertility treatments, the Health Department announced setting up of ART centres at the Institute of Obstetrics and Gynaecology (IOG) and Government Hospital for Women and Children, Egmore, and Government Rajaji Hospital, Madurai. S. Vijaya, director of IOG, where evaluation of couples with infertility and intrauterine insemination are being done, said the demand for IVF was increasing and many were turning to the government sector as treatment was expensive in the private sector.

Road ahead

On June 8, the State government notified the two new Acts. “The Acts will ensure proper implementation of norms. There will be an element of fear to contravene the rules if there are rigorous punishment and fines,” Dr. Viswanathan said.

The State-level Appropriate Authority has multiple members drawn from the Departments of Family Welfare and Law, as well as obstetrician-gynaecologist and social activist. Powers will be delegated to district authorities, and joint directors will undergo training. “There will be close monitoring of all ART clinics. Couples are eligible only on medical grounds, and so, this is one of the criteria that will be closely monitored,” an officer said.