Letter to Hon’ble Minister of Health and Family Welfare, raising issues and concerns related to assisted reproductive technologies (ARTs) and surrogacy
Shri Ghulam Nabi Azad,
Hon’ble Minister of Health and Family Welfare,
Government of India,
Dear Shri Ghulam Nabi Azad,
Sama-Resource Group for Women and Health and Jan Swasthya Abhiyan has been raising issues and concerns related to assisted reproductive technologies (ARTs) and surrogacy for the past many years. This is to bring to your notice a case of medical negligence resulting in the death of a 26 years old Yuma Sherpa, following an egg donation procedure at New India Clinic, Lajpat Nagar, New Delhi. The woman belongs to Darjeeling and was working in Delhi as a shop assistant in Lodhi Colony.
As per the newspaper reports in The Hindu and The Indian Express dated 1 February 2014 and the statement issued by the All India Democratic Women’s Association (AIDWA) who visited the family of the victim as well as, after the procedure of donation of the eggs on January 29th, the woman spoke to her husband on the phone from the recovery room of the clinic. When her husband reached the clinic, he found out that she was not responding. Even after he told this to the staff, he was told that it was because of the medications given to her. Later she was shifted in a critical condition to another hospital at a distance rather than other hospitals like AIIMS on the way. Her death in these circumstances raises many questions which need serious investigation.
We request you to take up this matter urgently and expedite an investigation into the case. Strict action should be taken against those who are found guilty and compensation should be paid to the family of the woman. We demand an immediate investigation into the case and punishment to the guilty and justice to the family.
We have seen in the last few years, that ethical practices almost cease to exist and worrying stories of unscrupulous means to maximize profit by cashing in on egg donors’ or surrogates’ vulnerability abound.
This incidence once again underscores the long overdue need to set up regulatory framework for the Assisted Reproductive Technologies (ARTs) for dealing with such cases. We have repeatedly submitted our concerns on the ART Draft Bill in order to ensure protection of rights of the surrogates and egg donors. The present ART Draft Bill (2013) needs to reviewed; we have sent our comments and recommendations on the 2010 Draft Bill and also on the ART Draft Bill (2013) [copied below]. We are attaching again the concerns of Sama on the Draft Bill and the proposed Act, and urge you to consider our concerns and recommendations.
As we have repeatedly argued for years, protections offered to egg donors and surrogates are completely inadequate, including in the current Draft ART Bill 2013, especially in terms of the medical risks they undertake. There is no mention of “death” in the entire Draft Bill.
The medical regimen, its implications and the experiences of egg donors or surrogates pose questions that are deeply political and have significant connotations at the policy level, which need to be addressed for protecting the rights of the egg donors and surrogates. It is therefore imperative that the number of oocytes ‘retrieved’ and embryos to be ‘harvested’ and “transferred” need to be restricted and strictly regulated taking cognizance of health implications and safety, age and other health conditions, etc., of women undergoing these procedures/arrangements. The focus should be on ensuring the protection of donors from any injury or death. Privileging the financial interests over considerations of egg donors and surrogates’ health, while evading any scrutiny by grounding all decisions in being “medically indicated”, poses a great challenge to the ethics of medical practice.
We hope that urgent attention will be paid to the Draft legislation (2013) and processes for review and incorporation of concerns will be initiated. We also hope that immediate action is taken against those involved in the death of Yuma Sherpa and justice is rendered to her family.
(Sama Resource Group for Women and Health )
(Jan Swasthya Abhiyan)
Greetings from the Medico Friend Circle (MFC)!
We cordially invite you to join us on the evening of 13th February 2014, 40 Years and Onwards! The Journey that is Medico Friend Circle (MFC), at the India Islamic Cultural Centre, Lodhi Road, Delhi on the occasion of 40 years of the Medico Friend Circle. It would be wonderful to have you with us while we celebrate, reminisce about our history and imagine the years ahead.
40 Years and Onwards! The Journey that is MFC
Venue: India Islamic Cultural Centre, Lodhi Road
Date/Time: 13th February 2014 / 5.00 pm – 8.30 pm
5.00 pm – 5.30 pm: The Journey that is MFC!
5.30 pm – 7.30 pm: Presentations and Discussion on key MFC Themes and Issues (Primary Health Care, Universal Health Care, Medicines, Communalism, Social Determinants of Health)
7.30 pm – 8.30 pm: Music by Vidya Shah
Do also join us for the day long programme on the 13th February and the Annual Meet on Discrimination and Health on the 14th-15th at the Indian Social Institute, Lodhi Road (Details given below).
Looking Back Looking Ahead! Through 40 years
We also invite you to be part of the 40 MFC years through the day long programme on the 13th February (11 am – 4 pm) at the Indian Social Institute (ISI), as we journey through history – pausing at each decade with friends who founded and joined the Circle, specific themes, debates, songs.
Venue: Indian Social Institute (ISI), 10 Institutional Area, Lodhi Road, New Delhi
Date / Time: 13th February (11 am – 4 pm)
Annual Meet: Social Discrimination and Health
You are also welcome to join the Annual Meet on 14th and 15th February at the Indian Social Institute (ISI), Lodhi Road, to be part of discussions and debates on the Annual Meet Theme: Discrimination and Health. (A detailed programme schedule is attached).
Venue: Indian Social Institute (ISI), 10 Institutional Area, Lodhi Road, New Delhi
Date / Time: 14th – 15th February / 9.30 am – 6.00 pm
You may be already familiar with MFC, a nation-wide platform of secular, pluralist, and pro–people, pro-poor health practitioners, scientists and social activists interested in the health problems of the people of India. Since its inception in 1974, MFC has critically analyzed the existing health care system and has tried to evolve an appropriate approach towards health care which is humane and which can meet the needs of the vast majority of the people in our country. Its only commitment has been to intervene in and understand the debates, policies and practices of health in Independent India. Such an organization would doubtless have as many different narratives of history as it has perspectives through its life.
MFC is a non funded group of members from various backgrounds from across the country – public health professionals, medical doctors, nurses, health activists, researchers, students and professors at medical colleges and others. The MFC bulletin (first published in 1975) and the MFC Annual Meets have contributed to many debates and discussions on a range of health related issues, for example, primary health care, universal health care, nutrition, occupational health, communicable and non communicable diseases, women’s health, medical education, etc.
We look forward to seeing you there for the event,
Dr. Sunil Kaul (Convener), Ms. Sarojini N. (EC Member) and
Ms. Manisha Gupte (Managing Trustee) on behalf of MFC
Capacity Building Workshop on Ethics and Regulation of Clinical Trials in India,organized by Sama–Resource Group for Women and Health, to be held at Bhopal on December 18-19th, 2013
A similar workshop was conducted at Delhi in February, 2013. Sama has been consistently working on the issues of rights violations and ethical misconduct in clinical trials in India over the last 4 years. In recent past there have been many examples of clinical trials that have taken place that disregarded ethical aspects and participant rights. At the levels of planning, design and implementation, there exists a striking lack of transparency thus jeopardizing the reliability and validity of drug research in the absence of adequate regulatory jurisdiction and systematic review of the industry. Recent parliamentary a standing committee reports on the functioning of the CDSCO office and on the clinical trials conducted by PATH validate the concerns raised by civil society groups. Subsequent developments in the regulatory framework for the clinical trials make it even more appropriate to discuss the issues regarding clinical trials. In this context, we are organizing this capacity building workshop to inform and initiate dialogue with regard to existing regulatory and provisions regarding clinical trials.
SATHI (Pune) in collaboration with Sama (Delhi) is organizing a workshop, on ‘Promoting patients’ rights and ensuring social accountability and rationalization of care in the private medical sector’ on 25-26 October 2013 at ISI, New Delhi
As we are aware, today denial of Patients’ rights, gross overcharging, irrational, unnecessary investigations and procedures by private hospitals are on the rise. Significant social unrest is emerging due to these practices of the private medical sector, which is today largely unregulated. Besides social and health activists, there is a small section of rational practising doctors who are also quite dissatisfied due to gross commercialization of the profession, as well as the inroads being made by a growing corporate healthcare sector. In this context, we need to document various cases of denial of patients’ rights, along with recording some testimonies of rational doctors who are in favour of social regulation, and we should use such evidence towards strongly demanding social regulation and accountability of the private medical sector.
With the advent of the Clinical Establishments Act (CEA) enacted by the central government in 2010, regulation of the private medical sector is now coming onto the agenda. Some states like Himachal Pradesh, Arunachal Pradesh, Mizoram, Sikkim, Rajasthan, Jharkhand, and Uttar Pradesh have adopted the central act in its existing form, while states like Chhattisgarh and Odisha have their own existing state acts, and states like Kerala and Tamil Nadu are in the process of coming out with their own separate acts. Delhi has its own redundant ‘Delhi Nursing Home Registration Act’.
Given the major gaps in various existing regulatory frameworks, it is important that further steps be taken urgently for effective regulation, which would address the rights and needs of ordinary patients, as well as concerns of rational doctors. Otherwise the regulatory process would be completely dominated by bureaucrats and corporate hospitals, leading to continued irrationality and exploitation, compounded by corruption by officials.
Given this background, for health activists/ civil society organisations working in health and interested activists from all over India it has become an urgent need to engage with the issues related to patients’ rights and regulation of private medical sector in their respective areas and states.
Sama is organizing a two and half day workshop, The Way Ahead: Strengthening the Response of the Health Care System to Gender Based Violence, New Delhi, 27-30 November 2013
Over the past two years Sama has been involved in initiatives for developing collective, strengthened understanding / perspectives of gender based violence as a health issue and strengthening health sector response to survivors of violence, through workshops with community based organisations, networks, health workers in the states of Bihar, Uttar Pradesh, Jharkhand, Orissa, Chhattisgarh, Rajasthan, Madhya Pradesh, Delhi, Assam and others.
Towards taking forward the discussions and outcomes of these workshops, and consolidating understanding and capacities of organizations from the different states Sama is organizing this two and half day workshop. Specifically this workshop will seek to:
- Enable an understanding and analysis of the health system in which response to gender based violence (sexual violence as well as ‘domestic’ violence) is located
- Build capacities in engaging with the health system to initiate / or strengthen response.
- Strengthen understanding and analysis of the law, policy, recent amendments, standard protocols and proformas.
- Learn from existing strategies amongst participants to initiate responses at different levels of the health system.
September 3, 2013
Report points to a serious dereliction of duty by many of the institutions involved
Health activists have appreciated the Parliamentary Standing Committee’s report on the “Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine by PATH in India.” They commended “its candid, transparent contents, which reflect the committee’s acknowledgement of the unethical nature of the HPV trials’’ conducted in the country.
In the trials, Program for Appropriate Technology in Health (PATH), with the support of Bill and Melinda Gates Foundation (BMGF), approval from the Western Institutional Review Board (WIRB) [all three private international parties], donations from Merck Sharp and Dohme (MSD) and Glaxo SmithKline (GSK), in partnership with Indian Council of Medical Research (ICMR) and along with the governments of Andhra Pradesh and Gujarat, through the national vaccination programme, delivered and administered HPV vaccines to 10-14-year-old girls in Khammam (A.P.) and Vadodara (Gujarat) districts.
The committee’s findings are wide-ranging: the nature of the project, the role of ICMR, the role of the Drugs Controller General of India (DCGI), the Informed Consent Process, the role of Ethics Committees (EC), the process of inquiry committee formation and function and the role of PATH.
The report points to a serious dereliction of duty by many of the institutions involved. In particular, it questions the role of the ICMR, DCGI, EC members and PATH.
The committee clearly stated that the demonstration project was a clinical trial, no matter what PATH called it.
The report said, “The demonstration project is a study of a pharmaceutical product carried out on humans and since the primary objective includes the study of serious adverse events, it is clear that clinical trial rule should apply.”
A statement issued jointly by Jan Swasthya Abhiyan, Sama – Resource Group for Women and Health, and LOCOST / All India Drug Action Network said PATH, by carrying out clinical trials on the pretext of observation/demonstration project, has violated all laws and regulations laid down for clinical trials by the government.
Though, the committee brought up insurance to the girls, it has not mentioned the compensation in its report from the sponsor or an ex-gratia to the parents of the girls who died after the administration of the trial, the statement said, while demanding that the parents and children be compensated for the grave violations of their rights, as clearly informed consent was not taken from a large number of parents and no assent was taken from the girls who were given the HPV vaccine, and no follow-up or proper management of adverse events and serious adverse events during the trial was done.
“We welcome the recommendations and sincerely hope the contents and recommendations of the 72nd report by the Parliamentary Standing Committee will be acted upon, that there will be concrete early follow-up and outcomes of the committee’s observations and recommendations,” the statement said.
Reacting to the report, PATH said it was troubled by the report’s “inaccurate characterisation of this important work.”
“PATH, a non-profit organisation, is committed to meeting the highest scientific, ethical, and legal standards in our work and to contributing our experience and expertise to address the burden of cervical cancer through transformative innovations such as vaccines, a statement issued by it said.
“The demonstration project in India was part of a four-country project to explore suitable vaccine delivery strategies and help provide evidence for national health authorities to make informed decisions about the potential benefits and challenges of introducing vaccines against HPV, the primary cause of cervical cancer,’’ the statement said.
PATH said ICMR reviewed and approved the protocol for this project, including its design and methodology. At the time of its review, the ICMR determined the project was a post-licensure observational study and not a clinical trial.
“The project did not seek to evaluate the efficacy or long-term safety of the vaccines, which had undergone clinical evaluation in India and had been licensed and approved by the Drugs Controller General of India.’’
ICMR’s view was crucial, as it established the approval processes and protocols for the work that followed. PATH designed the project protocols in compliance with ICMR’s instructions and fully complied with ICMR’s requirements regarding the necessary approval processes and the requirements of the State governments regarding consent processes, according to the statement.
“We believe that by following the guidance provided by ICMR, as well as the two State governments and three ethical review committees, we designed a project that met or exceeded the country’s existing regulatory standards for demonstration projects while providing the greatest health benefit to Indian women,’’ PATH said.
Tuesday, 13 August, 2013, 10:37am
Western celebrities such as Elton John and Nicole Kidman have used surrogates to fulfil their desire for parenthood. Now with two of Bollywood’s biggest stars, Shah Rukh Khan and Aamir Khan, and their wives having taken the same route, surrogacy has gained some respectability, if not a hint of trendiness, in India.
While it still carries considerable stigma in the country, the celebrities’ choice has eased the way for other couples to do the same.
Even so, critics say the practice is prone to abuse because of the lack of regulation and the severe wealth gap there.
Aamir Khan surprised India when he and his wife, film director Kiran Rao, announced in 2011 that their baby son, Azad, was born to a surrogate. The actor already had children from his first marriage, but Rao opted for surrogacy as a “last resort” after suffering a miscarriage.
“The publicity around their case helped to clear up a lot of misconceptions. They made it seem like a perfectly acceptable way of bringing a baby home. That’s the power of celebrity,” says Dr Kaberi Banerjee, a fertility specialist in New Delhi.
Then, in May this year, Shah Rukh Khan and his wife, Gauri, announced that after trying to have a child for two years, their baby son, AbRam, had been born in Mumbai to a surrogate. The couple have two other children.
Surrogacy is a US$2.3 billion business in India. Its established medical infrastructure, coupled with a surfeit of poor women desperate to earn some money by renting their wombs, have turned the country into a preferred destination for childless couples from around the world looking for a low-cost, straightforward way of becoming parents.
But because the procedure is unregulated, it’s open to malpractice. A study by the Centre for Social Research in New Delhi last year found that most of the 100 surrogate mothers interviewed did not understand the procedure or the contract they signed with commissioning parents and fertility doctors.
While awaiting the births, they are often forced to live in guarded homes and given only limited access to their families.
“We found that 60 per cent were illiterate. That means they are easy to exploit because they won’t understand the possible medical complications,” says the centre’s director, Dr Ranjana Kumari.
Other controversies surround the process, including issues of gender selection and caste.
A survey last year by the Delhi women’s group Sama showed Indian couples were prepared to pay more for a light-skinned surrogate from the right caste.
The survey said couples often used the same adjectives to describe the kind of surrogates they wanted as those used in matrimonial ads – fair, beautiful, high caste.
“Indians are obsessed with religion, caste and fair skin. Even when they are told that the baby won’t have any of the surrogate’s characteristics, they still feel that some mingling of blood and tissue in the womb will affect the outcome,” says Deepa Venkatachalam, Sama’s programme co-ordinator.
But Dr Naina Patel, who runs a fertility clinic in Ahmedabad, says most commissioning parents simply want the surrogate to be healthy.
“They sometimes ask about the caste, but their main concern is that she be healthy and follow a healthy diet while carrying the baby,” Patel says.
But in what is manifestly an unequal relationship, it is the commissioning parents who call the shots and set the conditions. Surrogate mothers are usually too poor and powerless even to demand the right to be with their families during the pregnancy.
Women’s groups point out that this inequality extends to the spousal relationship. When the fee is paid, it is usually the husband who decides how to spend it.
“In some cases, he uses it to pay off a loan, just fritters it away or starts some ill-conceived business which fails. The woman often has no say,” says Brinda Karat, a Communist Party politician and women’s activist.
That is why many surrogates, such as Sangita Rana, offer their wombs a second or third time.
“My husband started a business selling packed meals to office workers. It failed, and he lost the money I made from having a baby. So I’m here to do it again,” Rana says while awaiting a check-up at the Delhi Research Centre.
Fearing being ostracised, they carefully hide this arrangement. “My husband tells our relatives that we are moving for a year because of his job. They would refuse to speak to us if they knew what I do,” Rana says.
So, while becoming a parent by surrogacy is losing its stigma for celebrities, earning money this way is still a disgrace.
This article appeared in the South China Morning Post print edition as Womb service
August 1, 2013 10:19 IST
Against concerns of lack of clarity and sufficient protection for surrogate mothers in the draft ART Bill, 2010, the Planning Commission is set to appoint a committee for wider consultations
The Centre will set up an expert committee for wider consultations on the draft Assisted Reproductive Technologies (ART) Bill, 2010. The committee will deliberate upon very “grave and critical” concerns raised by stakeholders and explore possible ways to address these issues.
The decision was taken after the Planning Commission recommended substantive changes in the legislation and advised the Indian Council for Medical Research (ICMR) against pushing the draft Bill till the process of consultations was satisfactorily concluded.
The Planning Commission will coordinate the process of forming and facilitating this committee towards developing an efficient regulatory framework and legislation. This comes after a meeting convened by the plan panel with stakeholders in the Capital earlier this week who made a pitched demand for setting up an expert committee to look into some of the provisions of the Bill, according to Sama, a non-governmental organisation working on women’s health.
Sama has been engaged in Assisted Reproductive Technologies and commercial surrogacy, through research, advocacy, and creation of resources (including a recent film on surrogacy) over the past eight years.
The outfit was invited by the Planning Commission as part of their Civil Society Window initiative to present its views on commercial surrogacy in India. The meet, chaired by Dr. Syeda Hameed, Member, Planning Commission, was attended by representatives from the Planning Commission, Union Ministry of Health and Family Welfare, ICMR, Union Ministry of Law and Justice, the National Commission for Protection of Child Rights (NCPCR), and Office of the Registrar General of India, amongst others.
The discussion flagged concerns with regard to the unregulated industry, unethical practices, especially lack of protection of the surrogate women’s health and rights, sex selection, lack of employment opportunities, and other health and rights issues of children born through surrogacy arrangements, and issues related to their citizenship.
Given the presence of Dr R.S. Sharma (member secretary Drafting Committee of the Draft ART Bills 2008 and 2010), the deliberations focused on the content and provisions of the Bill. The “short-sightedness” of some of the provisions, the absence of sufficient protection for surrogate women and in general the lack of transparency, consultative processes involving domain experts, including organisations in the drafting of the Bill, and lack of clarity on nodal authority, were issues raised by the members.
The ART Bill has been hanging fire since 2008 when the first draft was prepared. It was revised in 2010 but is yet to get a final approval from the Union Law Ministry following which it will go to the Cabinet for clearance.
Commercial surrogacy is a multi-million dollar industry in India but there is no legislation to regulate surrogacy which is resulting in exploitation of poor women who offer their wombs for a price without realising the adverse health impacts.
Health activists feel that the ART draft Bill is designed to regularise and promote the interest of the providers (mainly the private sector) of these technologies rather than regulate and monitor the current practices. The Bill is also inadequate in protecting and safeguarding the rights and health of the women who undergo these ART procedures, surrogates, egg donors and of the children born through these techniques.
In the context of surrogacy, the draft Bill at present constructs surrogacy as an isolated problem and proceeds to resolve conflicts engendered by the practice, a perspective that is in favour of the industry. The surrogacy industry, in effect, seeks to open up the market by removing any legal impediments in its smooth functioning. It is also decidedly in favour of commissioning parents, Sama points out.
“Lack of transparency from ICMR on this ART Bill is quite known to us for many years. We were appalled to learn that ICMR has again revised the draft Bill 2010 which we came to know only at the Planning Commission (the 2012 ART Bill is not on the ICMR website). The Ministry and ICMR have never made an effort to have any consultation on this Bill with women’s rights, child rights, health rights and legal rights organisations,” activists said while hoping that the Planning Commission meeting would lead to some positive outcome towards greater civil society participation.
Abantika Ghosh : New Delhi, Thu Aug 08 2013, 09:09 hrs
The directorate general of health services (DGHS) has proposed that the option of surrogacy should be available only to married, infertile couples of Indian origin.
The suggestions forwarded by DGHS Dr Jagdish Prasad to the department of health research rule out surrogacy options for foreigners, unless they are married to a person of Indian origin. The suggestions also say that a woman may become a surrogate mother only once in her lifetime.
The health ministry, which is engaged in a tussle with the Planning Commission on NGO consultations over a law to regulate the “infertility” industry, has circulated a cabinet note on the Assisted Reproductive Technologies (ART) Bill. The DGHS is an arm of the ministry.
According to a recent survey on surrogacy done by a Delhi-based NGO, foreigners made up 40 per cent of the clientele, and were inevitably those who paid the most. It is estimated that approximately 2,000 babies are born every year in India through commercial surrogacy. According to CII figures, surrogacy is a $ 2.3 billion industry in the country.
According to the NGO’s survey, surrogate women were forced to live in hostels away from their families for a few lakhs, a sum that they forfeited in case of complications or a miscarriage.
There were allegedly cases where more than one woman were made pregnant with a couple’s children to increase the chances of success. After a certain cut-off period, all but one were forced into a miscarriage without telling them.
The DGHS suggestions, coming on top of the health ministry’s disagreements with the Plan panel on whether and to what extent NGOs should be consulted, have further dimmed the chances of a Bill that has been in the works for over five years, making it to the cabinet anytime soon.
Planning Commission member Syeda Hameed said, “Organisations like SAMA have worked extensively in the field and have domain expertise.
We have decided to make a small core group of the commission to see how we can use that field knowledge to make valuable additions to the Bill.”
Sources said the ministry has been less than forthcoming in accepting the panel’s insistence on wider stakeholder consultations.
DGHS Prasad has also suggested that the potential surrogate mother would have to be aged between 25 and 35 years, and may not have more than two children of her own. The original note made surrogacy services available to individuals, which by extrapolation meant gay/lesbian couples could opt for it, but Prasad has suggested a far more narrow band of eligibility in which only married couples qualify.
ICMR deputy director general Dr R S Sharma, who is dealing with the ART Bill, said he had not received Prasad’s suggestions. “He has spoken to me on the issue but his written suggestions will come to me through the department of health research,” Sharma said.
Prasad declined to elaborate on his suggestions but said they were important to regulate the industry. “There is a lot of corruption right now, from the way women are exploited to how the babies are treated by the foreigners who take them. There is a need to make a foolproof law,” he said.