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.
A paper by Sama, Health Insurance: Evaluating the Impact on the Right to Health (Working paper) based on a recently concluded study / review of CHI / SHI schemes in India, was disseminated. The findings of the study suggest the paucity of systematic reviews and comparative assessments undertaken to either test the assumptions underlying the expansion of health insurance across India or to examine the core contents of the right to health; they challenge claims of insurance as impacting equity, access, utilization, financial protection and quality. (Authors: Dr Anuj Kapilashrami and Deepa Venkatachalam).
Another paper, The Rashtriya Swasthya Bima Yojana (RSBY) experience in Chhattisgarh: What does it mean for Health for All? authored by Dr Madhurima Nundy (PHRN), Dr Rajib Dasgupta (JNU), Kanica Kanungo (PHRN), Sulakshana Nandi (PHRN and Chaupal) and Dr Ganapathy Murugan (PHRN) is being published by Sama.
The paper based on six studies of RSBY in Chhattisgarh questions the ‘tendency to pass off health insurance as Health for All’ and highlights the shortcomings in the design, constraints faced by public and private providers, and a range of beneficiary related issues. It discusses how the reach of RSBY is unfulfilled as a large proportion of the vulnerable population still remains out of its ambit due to low enrolment rates even as evidence of experience among those enrolled points to high out-of-pocket expenditures. Discussed in the frame the Right to Health, these issues gain further significance.
Notwithstanding the various issues that have emerged in the context of health insurance from different States of India, there are several questions to be asked What are the implications of RSBY like schemes for the health sector? Do they improve access and quality of care? What are the concerns about insurance schemes that are emerging from the country? Is health insurance, health for all?
The discussions will be in a mix of Hindi and English language. We look forward to your confirmation.