Joint press Release on Chhattisgarh Sterilizations and related issues

Health Activists held a Press Conference on 19th November to draw attention to the range of issues raised by the recent tragic and completely avoidable deaths of more than a dozen women and the critical condition of many more following their laparoscopic sterilis​ation in Bilaspur, Chhattisgarh.The manner in which the surgeries were performed, in complete violation of all standard operating procedures,and subsequent events amount to grave violation of some very basic health rights of the affected women.  In addition, they point to the callous and biased attitudes towards poor women that persist among health functionaries and policy makers, and the tenacious hold of the “targets” approach in the family planning programme despite statements to the contrary.

83 women -predominantly Dalit, tribal, and OBCs- were subject to sterilization within a short span of 5 hours. It needs to be pointed out that the sterilization procedures flouted two sets of Supreme Court Orders (Ramakant Rai Vs Govt. of India, 2005 and Devika Biswas Vs Govt. of India, 2012). These orders instruct that a maximum of 30 operations only can be conducted in a day,and only in government facilities with 2 separate laparoscopes; one doctor cannot perform more than 10 sterilizations in a day.  Notwithstanding such orders, we see that in Bilaspur a single surgeon performed about three times the permissible number of surgeries (83) in less than 5 hours in a private hospital which has reportedly remained closed for 15 years.

The state government has announced several measures – monetary compensation and support to the affected families for care of the children of the dead women; suspension of several officials, and appointment of an enquiry commission.  The High Court has also taken suo moto cognizance of the tragedy.  There are also statements that the doctor is not to be blamed and that the problem lay with contaminated medicines that were given to the women.  As health activists who have been repeatedly calling attention to the deep-rooted problems afflicting the health system in the country and advocating several remedial steps, we believe that these measures are not adequate and do not touch the systemic and policy factors that lead to such incidents.  We feel that these are attempts to obfuscate the actual causes of death and the reasons leading to the incident.   A series of issues need to be addressed in the immediate to medium to long term.

In the short term, a thorough, impartial and unimpeded investigation and medical audit must be done immediately, by a competent team of medical and public health professionals, into the causes of the deaths and the illness of the women who underwent the sterilization.  Accountability and culpability need to be clearly fixed for the deaths of otherwise healthy women following a medical procedure.  That would be one of the first steps towards ensuring that mistakes and lapses are not repeated and such tragedies do not recur.Even 10 days later, such an investigation has not been announced by the state.

It is pertinent to remember that the failures in implementing guidelines and standards, and other kinds of violations in the sterilization component of the family planning programme have been repeatedly raised by civil society groups over the last decade or so, and are the subject matter of several petitions in the Supreme Court, such as the two referred to above.  Given that a lot of documentation already exists from several parts of the country, it is the need of the hour to compile all these evidences to learn the lessons and also ascertain why its implementation is so shoddy and poor.

In the medium to long term, several policy matters and systemic issues need to be addressed; among these are: (i) to do away with the continued emphasis of the Family Welfare Programmes on female sterilization in the name of reproductive rights and reproductive health.  It is seen that despite all the talk and concerns expressed by the state and international agencies for women’s health and maternal health,at the ground level the action is centred on such sterilizations and institutional deliveries only for reducing maternal mortality. The state still focuses on such permanent methods of contraception  rather than provide safe temporary methods for spacing and increasing access to safe contraceptives. In addition to this,​the two-child norm significantly contributes to the pressures for sterilisation.  Such ‘Camps’ (euphemistically called ‘fixed day static’ camps) are routinely organised in many States in the country in an irresponsible manner. Health providers in many parts of India confess that they are under pressure to fulfil unwritten targets coming from the top.

(ii) to improve the dismal condition of the government health institutions, make them functional by improving availability of  doctors and other health personnel and medicines.  Why is it that despite years of planning and allocating money for health system improvements, under reproductive and child health, under the NRHM, and despite years of so-called technical assistance for improving health system management, there are no improvements at the ground level?    There is no substitute for increasing material, human and financial resources to strengthen the primary health institutions across the country.

This terrible incident should be taken as a wake-up call.This incident must be declared an emergency, and we demand that:

  1. An independent and comprehensive epidemiologically-sound investigation into this incident should be carried out. On the basis of the findings, responsibility must be fixed in terms of criminal negligence not only on the medical team which performed the operations, but also in identifying other officials who sanctioned and were involved in managing this particular camp.
  2. Negligence and contributory negligence may be fixed on all parties involved, including those providing contaminated surgical equipment, medicines, etc. State is vicariously liable and ought to pay higher compensations for the lives lost and also to those who are sick.
  3. Further deaths and damage arising of poor quality of health care system, lack of compliance with SOPs, inefficient oversight system for quality control of health care delivery at the grassroots, and medical negligence should be entirely eliminated.The govt should must be held Sterilization operations only in well fully equipped  government hospitals and sterilized places, not abandoned hospitals that are shut, or in make shift places, where sanitization and cleanliness is compromised and there is a high likely hood of women undergoing a procedure in acquiring infections.
  1. ​The ‘camp method’ with incentives and targets of sterilization should be stopped with immediate effect. Instead, sterilization should be offered as one of the options among other safe, non hazardous, non invasive, long acting methods of contraception. It should be provided as one of the services through an improved basic primary health care system.
  2. ​The family planning programme needs a thorough re-analysis and over-hauling, that centre-stages the reproductive and health rights of women. Emphasis should be placed on male sterilization such as vasectomy, and other forms of family planning methods including use of condoms which involves far lesser health risks.

Jan Swasthya Abhiyan

Sama Resource Group for Women and Health

All India Democratic Women’s Association (AIDWA)

National Alliance for Maternal Health and Human Rights (NAMHHR)

Medico Friend Circle (MFC)

Muslim Women’s Forum

National Federation of Indian Women (NFIW)

Nirantar

Coalition against 2 Child Norm

Healthwatch Forum UP

Initiative for Health & Equity in Society

Diverse Women for Diversity

Human Rights Law Network

Joint Memorandum on Deaths and serious health consequences for women following sterilisation procedures in Chhattisgarh

To
Shri Dr Raman Singh,
Chief Minister,
Chhattisgarh
Chief Minister’s Office
Civil Line, Raipur
Chhattisgarh – 492 001

17 November 2014

Subject: Deaths and serious health consequences for women following sterilisation procedures in Chhattisgarh

Shri Dr Raman Singh,

We, Health networks, Coalitions, Women’s Groups and concerned citizens, are deeply shocked at the negligence of the Health Department, Government of Chhattisgarh that has led to the deaths of 16 women and the critical condition of 47 other women following procedures of laparoscopic sterilisation in Bilaspur, Chhattisgarh.

As you are aware that these deaths and morbidities are evidently a result of a botched-up sterilization operation camp organized by the Department of Health and conducted in the premises of a non functioning and abandoned private hospital under the National Family Planning Programme in Takhatpur Block of Bilaspur District on 8 November 2014. Horrifically, during this camp, 83 women were subject to surgeries in a short span of 5 hours. Those who have died—predominantly Dalit, tribal, and OBC women—are victims of the worst violation of their reproductive and health rights, and have left behind shattered families and young children.

This tragedy raises grave questions about the unsafe, unhygienic conditions and the slipshod attitude with which these operations were conducted. Moreover, the women who are presently critical continue to get treatment in inadequate conditions, exposing them to further risks and danger.

The surgeries were conducted in complete violation of the Supreme Court Orders (Ramakant Rai Vs Govt. of India, 2005 and Devika Biswas Vs Govt. of India, 2012). These orders instruct that a maximum of 30 operations can be conducted in a day with 2 separate laparoscopes only in government facilities. Also, one doctor cannot do more than 10 sterilizations in one day. Despite this, a single surgeon in Chhattisgarh performed about three times the permissible number of surgeries (83) in less than 5 hours in a private hospital which has reportedly remained closed for 15 years. a blatant and complete violation of standard protocols.

The announcement of Rs 4 lakh compensation and suspension of officials (Director–Health Services; State Family Planning Nodal Officer; BMO,Takhatpur; the operating Surgeon; and Bilaspur CMHO) are not adequate to ensure that such incidents will not happen again. The systemic failures which led to this incident need to be addressed.

While understanding the specific lapses in the way the sterilisation camp in Chhattisgarh was organised, one should not forget the role played by the misguided and dangerous policies and practices of the governments in the area of family planning services. Such ‘Camps’ (euphemistically called ‘fixed day static’ camps) are routinely organised in many States in the country in an irresponsible manner. Health providers in many parts of India, confess that they are under pressure to fulfil unwritten targets coming from the top.

The state still focuses on permanent methods of family planning rather than temporary methods. In addition to this, the two-child norm significantly contributes to the pressures for sterilisation. All this despite the Government of India’s promises of ‘Repositioning Family Planning’ – to move away from permanent methods to spacing methods, and to increasing access to safe and effective contraceptives.

This incident must be declared an emergency, and we demand that:

- Immediate responsibility must be fixed in terms of criminal negligence not only on the medical team which performed the operations, but also in identifying higher officials of the state who sanctioned this particular camp.
– A proper epidemiologically-sound investigation into this incident should be carried out. A three-member probe team has been constituted but these members are a part of the state, which signals a serious conflict of interest and thus, there should be an independent inquiry committee.
– Further deaths and damage should be minimized. It must be ensured that the technically most competent medical care is provided to the women to avoid further deaths.
– The ‘camp method’ of sterilization needs to be stopped with immediate effect as quality of care is seriously compromised in mass sterilization programme to meet earmarked targets. Instead, sterilization should be provided as a service through strengthened basic primary health care services.
– Women, adolescents and men need to be provided with safe choices for contraception. Emphasis should also be placed on male sterilization such as vasectomy, which involves comparatively lesser health risks.
– Quality of contraceptive services, including counseling, has to be monitored both from within the system and from outside through community monitoring.
– The family planning programme needs upheaval and a re-analysis, that centre-stages the reproductive and health rights of women.

Endorsed By
1. Jan Swasthya Abhiyan
2. Sama Resource Group for Women and Health
3. CommonHealth
4. National Alliance for Maternal Health and Human Rights
5. Medico Friend Circle
6. Centre for Enquiry into Health and Allied Themes (CEHAT)
7. Saheli
8. North East Network
9. Manasi Swasthya Sansthan
10. Muslim Womens Forum
11. Nirantar
12. Sadhbhavana Trust
13. Vanangana
14. Sahiyar Stree Sanghtan
15. National Alliance for Peoples Movements (NAPM)
16. SOPPECOM
17. Olakh
18. SANGRAM
19. Queer Feminist India Reclaim the Night
20. Jagori
21. LABIA
22. Forum Against Oppression of Women
23. Prayas
24. AIDWA
25. Oxfam India
26. Centre for Health and Social Justice
27. Partners Law In Development
28. AIPWA
29. AKL KA DHABA Collective
30 . National Federation of Indian Women
31. PWESCR
32. Bhopal Gas Peedit Mahila Stationery Karmchari Sangh
33. Bhopal Group for Information and Action
34. Dr Kavita Panjabi
35. Prof Gita Sen
36. Prof Uma Chakravarthy
37. Admiral L Ramdas
38. Lalita Ramdas
39. Prof Ilina Sen
40. Rajashri Das Gupta
41. Dr Veena R Poonacha, SNDT Women’s University
42. Shahida Murtaza
43. Rachana Johri , AUD
44. Neeraja Ved Malik
45. Nandini Rao
46. Anuradha
47. Farah Naqvi, Journalist
48. Sadhana Arya
49. Kalyani Menon Sen
50. Surabhi Sharma
51. Juhi Jain
52. Ayesha Kidwai
53. Radhika Desai
54. Poulomi Pal
55. Ramlath Kavil
Supriya Madangarli
57. Amrita Shodhan
58. Geetanjali Gangoli
59. Shreya Ila Anasuya
60. Lata PM
61. Vasudha Mohanka
62. Prof Vibhuti Patel
63. Runu Chakraborty
64. Swati Sheshadri
65. Sumi Krishna
66. Prof Mohan Rao
67. Dr Amar Jesani
68. Dr Dhruv Mankad
69. Dr Veena Shatrugna
70. Paromita Vohra
71. Dr Joe Varghese
72. Dr Bijoya Roy
73. Sulakshana Nandi
74. Indira Chakravarthi
75. Ravi Duggal
76. R. Srivatsan
77. Kiran Shaheen
78. Lata Singh
79. Dr Sunil Kaul
80. Sandhya Srinivasan
81. Bindhulakshmi TISS
82. Dr Mira Shiva
83. Nandita Gandhi
84. Roshmi Goswami
85. Janaki Abraham
86. Amrita Nundy
87. Dr Hazel D’Lima, Retired Prinicipal, Nirmala Niketan College of Social Work
88. Astrid Lobo
89. Dr Kaveri RI, WSS
90. Dr Padmini Swaminathan
91. S. Srinivasan LOCOST
92. Kamla Bhasin
93. Soma KP
94 Jarjum Ete, APWWS
95. Dr Anita Ghai
96. Rohini Hensman

HT

Sterilisation deaths: Rusty, infected tools killed women in Chhattisgarh?

 Ejaz Kaiser, Hindustan Times  Bilaspur, Chhattisgarh, November 12, 2014                                                

First Published: 20:41 IST(12/11/2014) | Last Updated: 09:47 IST(13/11/2014)


Furious protesters took to the streets in Chhattisgarh on Wednesday as activists complained standard procedures and guidelines were not followed in the state’s mass government-run sterilisation programme that left 13 women dead.

A team of doctors rushed to Bilaspur to investigate the deaths following the operations performed by a doctor accused of using rusty equipment in an operation theatre that had not been used for four months.

The cause of the deaths was not immediately clear, but officials said the victims showed signs of toxic shock, possibly because of dirty surgical equipment or contaminated medicines. The victims had suffered vomiting and a dramatic fall in blood pressure after undergoing laparoscopic sterilisation, a simple process in which the fallopian tubes are blocked.

“Preliminary examinations suggest septic shock may have caused the deaths,” said local government official Amar Thakur. “It looks like the equipment that was used was probably infected. We are waiting for the report.”

A total of 83 women, all villagers under the age of 32, had the operations on Saturday and were sent home that evening, but more than 50 became seriously ill later and had to be hospitalised.

The expert team from Delhi’s All India Institute of Medical Sciences (AIIMS) reviewed the clinical details of the women who fell ill, but did not say what led to the deaths.

“All of us unanimously think that the cause of the illness can only be ascertained after all laboratory results and post-mortem findings are available,” said Dr Anjan Tirkha, who headed the seven-member team.

Sources said the death may have been caused by drugs prescribed to the patients or internal malfunctioning resulting in renal failure, respiratory failure and liver infections.

The doctor has been accused of operating on more than 80 women in just a few hours with the help of two assistants in an abandoned private hospital, officials said.

Police have filed a case of causing death by negligence against the doctor, RK Gupta, Bilaspur IGP Pawan Dev told HT.  The state government rewarded Gupta on January 26 for accomplishing his target of laproscopic tubectomies.

N Sarojini, founder and director, Sama Resource Group for Women and Health, said the Bilaspur surgeries violated Supreme Court orders saying that a medical team can conduct a maximum of 30 operations in a day with two separate laparoscopes.

“One doctor cannot do more than 10 sterilisations in one day, yet the surgeon in Chattisgarh did an astounding 83 surgeries in a short span of five to six hours… The scale of these deaths and critical morbidity clearly show that these operations were not done under standard protocols,” she said.

“The only step that has been taken by the government till now is to announce Rs. 4 lakh compensation for the families of the dead and suspension of some doctors. These steps are not adequate to ensure that such incidents do not happen again. The systemic failures that led to this incident need to be addressed.”

Although the surgery is voluntary, rights groups say the target-driven nature of the programme has led to women being coerced into being sterilised. Women are given Rs. 1,000 rupees and men Rs. 2,000 as incentive to undergo the procedure.

Shiv Kumari Yadav, 26, and Parvati Bai, 25, said they would not have opted for the procedure had they known about the surgeries were carried out in an unhygienic operation theatre. “Two women were simultaneously handled on the two parallel beds by the doctors,” said one of the patients.

The Chhattisgarh high court has issued notices to the union and state governments as well as the Medical Council of India seeking a detailed report within 10 days.

mint

Surrogacy industry thrives in India amid regulatory gaps

Surrogacy industry thrives in India amid regulatory gaps

http://www.livemint.com/Politics/1tiGqG9X9ChMt9Tb1pmNpM/Surrogacy-industry-thrives-in-India-amid-regulatory-gaps.html (First Published on THU, OCT 30 2014. 01 13 AM IST)

New Delhi: When Prime Minister Narendra Modi launched the “Make in India” campaign on 25 September, surrogacy would have been last thing on his mind. Now a leading fertility expert in the capital says she has been inviting couples—many of them foreigners—to “make in India” for years. “Our Prime Minister is knocking doors and inviting the world to come ‘Make in India.’ We are giving people a ‘make in India’ family,” said Rita Bakshi, an IVF (in vitro, or artificial, fertilization) expert. A register marked “surrogacy” lies on her desk in her well-appointed South Delhi office. Next to it is an Excel sheet tracking the health parameters of surrogates with Bakshi’s International Fertility Centre in Delhi. At any given time, she says, her clinic handles 100 to 150 surrogacy cases. She spoke as lawmakers prepare to debate a Bill aimed at regulating the commercial surrogacy sector, in the upcoming winter session of Parliament. India has an estimated 20-25 million infertile couples, for many of whom assisted reproductive technology (ART) represents a solution to their problem. For infertile foreigners and non-resident Indians (NRIs), ART in India is a relatively inexpensive proposition. For medical practitioners, it is a market opportunity with the number of IVF cycles creeping up from an estimated 7,000 cycles in 2001 to 85,000 in 2011. The number of clinics offering these services has shot up from 59 in 2001 to close to 600 by 2011. According to Bakshi, nearly 30-40% of couples who come to her are foreigners, 30% foreigners of Indian origin, and the rest Indians. According to Mumbai-based ART consultant Parikshit Tank, “the vast majority of surrogacy cycles are conducted for standard, well-established indications for Indian nationals”. Surrogacy is only one aspect of ART, yet it is the one that seems to get the most publicity—often for the wrong reasons. The shortcomings in India’s legal, yet unaccredited, unsupervised and unregulated commercial surrogacy sector came to light recently when an Australian couple was found to have abandoned one of their twin babies born to an Indian surrogate—apparently because they already had a child of the same sex. The incident came to light in an interview given by the Australian family court chief justice Diana Bryant, who had been informed of it by the Australian high commission in New Delhi. There is no information available about what happened to the child. This has added to an already heated debate about the rights of the child, the role of IVF clinics and the responsibilities of commissioning couples in India’s unregulated landscape of commercial surrogacy. Some rules are hard to fathom. For instance, guidelines allow single Indian parents to commission a surrogate. But single foreigners are excluded for some reason. “This inconsistency leads to a lot of confusion. We should allow couples who are legally allowed to adopt in their home country to commission surrogates here. While the administration is offering lifelong visas for PIOs (persons of Indian origin), we are in the process of shutting doors which were previously wide open,” said Bakshi, referring to surrogacy and the changing guidelines on who is eligible to be a parent and who is not. The government’s July 2012 guidelines say commissioning foreigners are required to have been married for at least two years before seeking a surrogate baby in India, thus shutting out foreign single parents and homosexual couples. In addition, commissioning foreign parents need a letter from their embassy in India or their foreign ministry stating that the country recognizes surrogacy and the baby will be allowed entry in the parents’ country as their biological child.

Regulatory issues

Commercial surrogacy has been allowed in India since 2002 but remains an unregulated grey area. In 2008 the Supreme Court said in a judgment that surrogacy as a medical procedure “is legal in several countries including in India”, without elaborating on what makes surrogacy legal. This was in the “Baby Manji Yamada” case in which the commissioning parents divorced during the pregnancy and the commissioning mother refused to accept the baby. The court finally granted custody to the baby’s grandmother. In 2008, another case, on the citizenship of surrogate babies led the Gujarat high court to state that there is “extreme urgency to push through legislation”, which addresses issues that arise out of surrogacy. A United Nations-backed study conducted two years ago estimates the surrogacy business in India to be worth more than $400 million a year, but civil society activists say the size of the market could well be more than twice that amount. A draft ART Bill has been pending in Parliament since 2010 and is now expected to be taken up in the upcoming winter session beginning 24 November. This too has become a subject of controversy, with civil groups saying they have not been consulted over its drafting. “There are so many people who have done tremendous amount of research who can contribute to the regulation and drafting of a comprehensive Bill but the ICMR (Indian Council of Medical Research) has been very non-transparent. It is difficult to get information about the Bill,” said Deepa Venkatachalam of Sama, a New Delhi-based resource group that works with issues of women and health. The proposed Bill is India’s first attempt at regulating the sector although The National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India have been around since in 2005 and subsequently amended in 2008, 2010 and 2013. In its current form, the Bill is an impressive document. ART banks, under the Bill, will now be registered and commissioning parents will have to go to these registered banks to identify surrogates, said R.S. Sharma, deputy director general of ICMR and a member of the drafting committee for the Bill. The Bill also seeks to streamline the process of recruiting surrogates, who currently earn anywhere between Rs.1.5 lakh to Rs.4 lakh for their services—with a 25% “bonus” for delivering twins. The Bill will require the commissioning couples to approach registered ART banks and not private IVF clinics, as is currently the case. “This will address a lot of malpractices by private banks. Since a government-approved bank will be involved from the very beginning, the margin of errors is reduced when it comes to the chances of babies being abandoned or the surrogate being treated unfairly,” added Sharma. More importantly, professional surrogates will be registered with these banks and will need an Aadhar card to be eligible. “This will iron out issues about the exploitation of commercial surrogates. Currently, there are so many malpractices when private clinics advertise for surrogates and the money paid is arbitrary. They charge too much from commissioning couples and pay too little (to surrogates). We are hoping the Bill will end these issues,” said V.M. Katoch, director general of ICMR. Moreover, the Bill will continue with home ministry guidelines that stipulate that surrogacy services will be offered only to those foreign nationals who come from countries that legally recognize surrogacy.

Disturbing practices

One problem, however, is the lack of hard data about the sector. As things stand, there is no reliable data even about the number of ART clinics. There is a National ART Registry of India (NARI) but disclosures there by medical practitioners on pregnancy rates, live birth rates, the number of cycles and so on are purely voluntary and do not tell the whole story, said Manish Banker, executive director, Nova IVI Fertility, Ahmedabad and a member of the government board on the Bill. The problems with commercial surrogacy in India are both ethical and legal in nature. The absence of regulation raises the spectre of a surrogacy black market, baby-selling and even questions of legal rights of a surrogate and the baby. For instance, before a pregnancy is commissioned a contract is signed between the parties involved. However, according to a recently published study by the Centre for Social Research (CSR), an NGO dealing with women’s issues, 88% of surrogate mothers in Delhi and 76% in Mumbai who were interviewed for the survey did not know the terms of their contract. In fact, 92% of the surrogates in Delhi did not even have a copy of the contract and only 27% of the clinics in Delhi and 11.4% in Mumbai were party to the contract. The contract is usually signed between the surrogate mother, her husband and the commissioning parents. “What is the legality of these contracts? The few that I have seen consist of a four-line paragraph on a Rs.100 stamp paper simply stating that the woman is entitled to a certain amount of money for being a surrogate and she has no claim on the baby. It’s a mockery of the term (contract),” said Manasi Mishra, who heads the research division of CSR. Clinics refute this claim. According to Inderbir Singh, a Delhi-based lawyer who has drafted several surrogacy contracts, the agreements are comprehensive and address all difficulties that could arise from the business. “An important clause in the contracts is that either party, be it the surrogate mother or the commissioning parents, is free to approach the civil court for enforcement of the contract,” he said. Mishra’s study also threw up some disturbing practices. In some clinics, she claims, up to three embryos are transferred in the womb of the surrogate. “Normally, two mature. There are times when all three mature. Depending on the sex and the gender preference of the commissioning parents, the third embryo is removed,” said Mishra. This process is known as foetal reduction. The study reveals poverty and education of children as the motivating factor for women to become surrogates. Himanshu Bavishi, president of the Indian Society for Third Party Assisted Reproduction (INSTAR), private association of IVF clinics, said most professional surrogates were women with high aspirations and little money. “There is no question of compromising the rights of commercial surrogates. They are not beggars, but women who have aspirations and their usual jobs as domestic helps would not let them meet these aspirations. Being a surrogate gets them the money their regular jobs would not,” added Bavishi. Another issue of concern is the medicalization of the surrogate mother’s bodies. From lack of awareness about the number of cycles they might have to undergo to the side effects of gestational surrogacy—the only kind allowed by India—surrogates, activists say, always end up disadvantaged. Unlike traditional surrogacy which uses the surrogate’s own egg, gestational surrogacy involves suppressing the surrogate’s ovulation cycle and injecting hormones to prepare her uterine lining for the embryos which are made either by the commissioning mother’s own eggs or a third party donor’s eggs. This procedure can later lead to side-effects like mood swings, irritability and depression, facts which activists say are not always shared with the surrogates.

Biological vs Genetic

“Much is made of the phrase ‘informed consent’, of the surrogate but it’s a grey area. How much does she know about the process? Emotionally, physically, it’s a very invasive. There is no cap on the number of cycles she might have to go through before the embryo is attached. Also Caesarean are conducted in order to co-ordinate the birth with the arrival of the commissioning parents,” said Sama’s Venkatachalam. Surrogate mothers are often counselled over the importance of separating themselves from any emotional bond with the foetus. They are advised that while they might be carrying the child there is no genetic link. Venkatachalam finds this argument troubling. “What is biological and what is genetic? A woman carrying a child is not seen linked to it if she has not provided her eggs. Would her link be greater if she did so?” The CSR study quotes a paper by Amrita Pande, a senior lecturer in the sociology department of the University of Cape Town as saying, “The surrogate is expected to be disciplined and a willing contract worker who will give away the baby…without creating a fuss. But, simultaneously she is expected to be a virtuous, nurturing mother attached to the baby…”. However, many doctors describe surrogacy in terms of not just empowerment but also compassion. “Yes these women are economically deprived. They are bothered about their children but somewhere their decision to be a surrogate is also motivated by philanthropy. When we counsel them, they meet the intended parents and understand their agony and pain. They understand that they are not doing it for money, it’s but a byproduct. I tell the parents she is doing upkaar (favour) for you,” said Bakshi. All parties concerned hope that the Bill will address issues concerning the health and economic rights of surrogates. Bakshi feels the government could consider introducing a cap for a minimum fee to be paid to the surrogate. Currently there is no provision for post-partum care of the surrogate. “Our research uncovered that clinics hand over a multi-vitamin pack to surrogates after birth in the name of post-partum care,” said CSR’s Mishra. Moreover, what happens if the surrogate miscarries, say, in the seventh month of her pregnancy? Does she get sent home without any pay or is she entitled to some money? In 2012, 36-year-old surrogate mother Premila Vaghela died in childbirth in the eighth month of her pregnancy in Ahmedabad. The baby, however, survived. News reports at that time suggested that thefamily was planning to refuse any compensation offered. This was different from the money promised in lieu of surrogacy. Right now surrogacy works through middlemen and word-of-mouth. According to the CSR report, 73.7% of the surrogates in Delhi were approached by agents whereas in Mumbai the figure was 73.21%. “The agents usually are men with some standing in the community who are respected and trusted. They have observed these women, their needs and recruit accordingly,” said Sama’s Venkatachalam. The recommendation of a family member also acts as a powerful initiative. Several surrogates have also been discovered to have been egg donors in the past, implying familiarity with the networks in place. As the government mulls over the Bill, the sector has lost business to the neighbouring countries where affluent couples can get affordable, hassle-free alternatives to becoming parents. “In 2012, the Indian government passed the directive that we could not cater to single parents and homosexual couples. Then they added conditions like the commissioning couple has to be married for at least two years prior to opting for surrogacy. Such lengthy and tedious government procedures have let to a lot of business moving to Nepal and Thailand,” Bavishi added. And then, there are doctors who believe that except for the rare aberration, the system is working fine with the current ICMR guidelines. “Barring a few considerations, the clinical practice of surrogacy is straight-forward,” says Tank, the Mumbai-based ART consultant. “Most of the Bill’s provisions are already being adopted in practice.”

BMJ
Taming the international commercial surrogacy industry

BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g6334 (Published 23 October 2014)
Cite this as: BMJ 2014;349:g6334

Sally Howard, freelance journalist, London, UK
admin@sallyhoward.net


The recent case of surrogate baby Gammy, left in Thailand by his commissioning parents after being born with Down’s syndrome and a congenital heart defect, provoked censorious press coverage worldwide. “Surrogate mom vows to take care of abandoned twin,” ran the typical headline when the story broke in August. Outrage grew when it emerged that the father had 22 child sex convictions.1

But behind its sensationalised aspects—taking one healthy child from twins and the questionable background of the Australian father—the case was more legally and ethically nuanced than it might have seemed.

Gammy’s gestational mother, 21 year old Thai food vendor Pattaramon Chanbua, told news agency Agence France Presse that she had found out that one of the twins had a chromosomal disorder four months into the pregnancy.1The commissioning parents, David and Wendy Farnell, told Australia’s Channel Nine television (60 Minutes, 9 August) that they had then urged Chanbua to selectively abort the abnormal fetus.

Abortion is illegal in Thailand, except in cases of rape or incest or endangerment to the mother’s life or mental or physical health.2 It is unclear whether abortion for a birth defect was stipulated in the surrogacy contract between Chanbua and the Farnells. However, Chanbua claimed that she refused to abort the child because it was against her Buddhist faith. She also complained that she has been promised $9300 (£5800; €7300) to carry the children but had not been paid in full.3

Gammy remained in Thailand under the care of Chanbua who, under Thai law, was considered the child’s mother. After the case gained media attention, pressure grew to repatriate the 7 month old to Australia, where he was also offered citizenship and where he would be entitled to free healthcare for his complicated birth conditions.

“A bodge job or worse”

The family law barrister Barbara Connolly QC says that the labyrinthine tangles of family, immigration, and contract law exposed by Gammy’s case are typical of international commercial surrogacy.

“When it comes to commercial surrogacy our laws are a bodge job or worse,” she told The BMJ. “Unlike international child abduction and adoption, there are no international conventions and agreements in this area. Legal issues relating to parentage and immigration vary so widely that the process can result in dramatic outcomes, such as a child born via surrogacy who is both legally orphaned and stateless.”

The legal status of commercial surrogacy varies from country to country. In some countries, including Georgia, Ukraine, and South Africa, all surrogacy agreements are legal and enforceable. Other nations, such as the United States and Australia, regulate or criminalise commercial surrogacy with a patchwork of common law and case legislation that is enforced at state level. France, Italy, and Switzerland ban all forms of surrogacy and will not recognise children born through commercial surrogacy abroad as legal citizens. In the United Kingdom and Denmark altruistic surrogacy (when the mother can receive only reasonable expenses) is permitted but agreements are unenforceable and commercial surrogacy is banned. However, when couples have sought commercial surrogacy abroad, the courts may retrospectively sanction payments that have already been made in the interests of the child.

Asia legislates

The call for a unified legal framework around commercial surrogacy is loudest in the “fertility tourism” destinations of the global south. In Thailand, where the commercial surrogacy industry is worth $125m according to the Thai Department of Health Service Support, the military government responded trenchantly to the baby Gammy case by approving a draft law to criminalise commercial surrogacy. If the law is approved by Thailand’s National Legislative Assembly in early 2015, it will criminalise both commercial surrogacy agencies and commissioning parents, allowing only altruistic surrogacy for infertile, married Thai nationals.

Reverberations are being felt most keenly in India, the world’s largest destination for fertility tourism. (The Indian commercial industry, legalised in 2002, was valued at $449m in 2006.) Last month the Indian government introduced into parliament the 2010 Assisted Reproductive Technologies Regulation (ART) Bill, which has been grinding on to the statute book since 2008.4 The bill, in its current draft, includes a chapter that considers oocyte donors, gestational surrogates, and surrogate born children in altruistic and commercial surrogacy agreements. When the bill is enacted, surrogacy agreements will become legally enforceable, and the age and background of surrogate mothers will be restricted. All foreign surrogacy arrangements will require the appointment of a local guardian who is legally responsible for the surrogate mother throughout the pregnancy as well as the resulting child if the commissioning parents fail to claim him or her.

Indian wombs for hire

This law change comes after the Indian Ministry of Home Affairs issued new guidelines on surrogacy in January 2013. These included a visa requirement for foreign nationals commissioning surrogacy in India, with such visas being restricted to married couples from countries where surrogacy is legal.5 N B Sarojini, founder of the non-profit making Delhi based women’s health advocacy and research organisation Sama, thinks that these regulations have done little to curb what the Indian press has derisively referred to as the trade in “Indian wombs for hire.” Sarojini, who has lobbied for amendments to the ART bill, hopes that the new legislation will check the untrammelled commercialisation of India’s assisted reproduction industry but fears that the bill will be “hugely lacking” in its reach.

“The ART bill has been led by the ART industry—that is, by commercial clinics and gynaecologists, largely for the purpose of validating this lucrative business,” she says. “It fails to regulate big players in the industry, such as surrogacy agents. And it provides little support, or legal recourse, for the gestational surrogate. It seems the free trade mandate brushes aside all ethical questions.”

Sarojini argues that, although the new bill imposes restrictions on the number of embryo transfers a surrogate can accept for a commissioning couple (three) and the number of children a surrogate can bear (five, including her own children), the bill makes no provision for the health of the surrogate beyond the bounds of the nine month gestational contract. In a climate where the public healthcare sector is under-resourced, says Sarojini, such omissions are unethical.

An early draft of the bill said that the health risks to the surrogate mother were small. But Deepa Venkatachalam, who also works for Sama, says the organisation’s research shows that surrogacy “can have grave effects on women’s health. The surrogate is subjected to repeated hormonal injections in preparation for implantation, putting her at risk of ovarian hyperstimulation syndrome, and most surrogates undergo non-indicated caesarean sections to time the birth for the commissioning parents’ convenience.”

Human trafficking

Anil Malhotra, a lawyer based in the north Indian city Chandigarh, is also a critic of the upcoming legislation. At a conference on surrogacy organised by the Centre for Social Research, a New Delhi non-governmental organisation, in September he raised concerns that the bill fails to consider the background and credentials of commissioning parents, a problem that emerged in the baby Gammy case.

“As the bill stands, there is no requirement to verify the background of commissioning parents,” Malhotra told The BMJ. “At the minimum, the home study reports mandated under CARA [India’s Central Adoption Resource Authority] guidelines on inter-country adoptions should be applied, under the bill, to cross-border surrogacy arrangements.”6

Malhotra also noted the absence of a clause pertaining to human trafficking for surrogacy. In 2009 the United Nations Development Programme warned that trafficking of women for commercial surrogacy would eventually develop.7 Just two years later, 13 Vietnamese women, seven of whom were pregnant, were rescued from a surrogate “baby breeding ring” in Bangkok.8

“You cannot just close your eyes and hope that baby breeding cartels won’t develop,” Malhotra said. “With such financial incentives involved, it’s a false hope.”

Malhotra argued that India is losing its opportunity to set a legislative standard for surrogate source nations: “To have any hope of keeping pace with socioeconomic conditions and technological advancements, we need a one-stop-shop piece of surrogacy legislation that covers both domestic and international surrogacy arrangements,” he said. “Scattered pieces of legislation won’t do.”

China’s ban

China is one of the few Asian nations to have taken a firm stance on commercial surrogacy from the outset. In 1994, as gestational surrogacy was emerging, the Chinese government banned commercial surrogacy on the grounds of its implications for defining true parenthood. However, by the early 2000s an unregulated market was flourishing. In 2009 the Chinese government strengthened the criminal enforcement of the surrogacy ban, and reports emerged of surrogates having forced abortions.

Health and human rights campaigners say there is a pressing need for an international legal framework to regulate the commercial surrogacy industry. But such agreements will be a long time coming. The Hague Conference on Private International Law convened to consider international surrogacy arrangements in March 2012 and April 2014. It will reconvene in early 2015. To Connolly, the conferences’ preliminary reports make for sober reading.9 10

“The reports highlighted the huge problems in these cross border arrangements,” she said. “But they also pointed to the real obstacles in the way of reaching any kind of international consensus, let alone a convention, on the issue. As an indication of how long these conventions can take, Japan only signed up to the Hague Convention on International Adoption, which was drafted in 1993, earlier this year.”

Meanwhile there is pressure for affluent nations to legalise the commercial surrogacy market within their own borders. Connolly agrees that the argument is attractive. “But you have to be realistic about market forces,” she said.

“If you liberalise commercial surrogacy in the UK you won’t prevent UK nationals from seeking a cheaper surrogate abroad. For example, as India and Thailand impose restrictions there are signs that an unregulated commercial surrogacy industry is emerging in Mexico.”

For baby Gammy the future is bright. He will soon live with his surrogate mother in a new three bedroom apartment paid for with funds from the reported $AU240 000 (£130 000; €165 000; $210 000) donated to a charitable endowment established for his long term care.11 For the industry that brought Gammy into being, the future is less certain.

Modern surrogacy: the birth of an industry

·         In 1980, two years after the birth of the first baby conceived in vitro, Louise Brown, the US lawyer Noel Keane wrote the first legally binding surrogacy contract through his own infertility centre, a business that sought to connect couples to willing surrogates.

·         In 1986 Keane wrote the contract pertaining to Baby M, a controversial case in which surrogate Mary Beth Whitehead refused to cede custody of the resultant child, Melissa, to the couple with whom she made the surrogacy agreement. The case led many US states to ban commercial surrogacy arrangements.

·         In traditional surrogacy the egg of the surrogate mother and the sperm of either the intended father or a sperm donor are used. From the 1990s advances in in vitro and implantation methods enabled gestational surrogacy, in which the surrogate carries a child she is not genetically related to, created from eggs and sperm of the intended parents or donors.

·         The arrival of gestational surrogacy led to a boom in commercial surrogacy worldwide. The global industry is now estimated to be worth $6bn12

References

For references, please click on the following link

http://www.bmj.com/content/349/bmj.g6334

National Seminar on Compensation in Drug Trials, 14th and 15th July 2014 Delhi, Organized by Sama, LOCOST, PHFI and TWN

Compensation is a widely debated issue globally in the context of clinical trials and the regulations concerning compensation vary across countries. In India, Compensation in the context of clinical trial related adverse events, ranging from relatively minor harm to major injuries or even disastrous injuries (leading to permanent disability or even death) are some of the issues being raised consistently. In January, 2013, Government devised a formula to determine compensation for serious adverse events of death occurring during the clinical trial and in May, 2014 a set of formulae has been devised to determine compensation for clinical trial related injury (other than death).

Sama has been engaged with issues related to clinical trials and has worked towards a constructive dialogue between various stakeholders to deliberate on various ethics and regulation issues related to clinical trials. In this context, a two day national seminar is being organised by Sama Resource Group for Women and Health along with LOCOST Therapeutics, Public Health Foundation of India (PHFI) and Third World Network (TWN). The seminar will be attended by multiple stakeholders such as Principle Investigators, Civil Society Members, Ethics Committee Members, Pharma representatives, CRO representatives, bioethics experts, and academicians. The seminar aims to discuss the mechanisms for compensation including the recent formulae.