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Indian Regulators Have Cleared the Way for Uterus Transplants Without Sufficient Research

Concerned authorities have been lackadaisical about drafting regulatory guidelines for this new and controversial transplant procedure.

Uterus transplants have not been easy across the world. Credit: Reuters

Uterus transplants have not been easy across the world. Credit: Reuters

In July 2017, Rajya Sabha MP K.V.P. Ramachandra Rao asked the health ministry if the government is aware of the “success” of the first two uterine transplants and what their opinion on it is, which is, whether uterine transplants “deserve a fair chance” akin to in vitro fertilisation and surrogacy. The response to the question merely stated that health is the duty of the state and it is up to the state authorities to oversee such matters according to the provisions of the Transplantation of Human Organs and Tissues Act, 1994 (THOTA).

Uterine transplantation technologies seek to confer fertility on women who are unable to conceive biologically due to the absence of or specific malfunctions in the uterus. There have been quite a few media reports on uterine transplants following the first two that were conducted in the Galaxy Care Hospital, Pune on May 18. The Milan Fertility Centre in Bangalore is also planning to conduct two operations, for which they have sought approvals from the Karnataka State Transplant Appropriate Authority and the Indian Council of Medical Research (ICMR).

While the operations conducted at Pune were carried out as routine therapeutic transplantations, the one to be conducted in Bangalore is being called a research experiment. There has been much excitement around this new technology. However, the technology also raises several ethical concerns, including reinforcing patriarchal notions of biological parenthood, as we have argued in a previous article published in The Wire. In this article, we closely examine the nature of approvals that were granted to these operations in India and assess whether sufficient regulatory mechanisms are in place to ensure safe implementation of this experimental procedure which has been deemed as risky.

Uterus transplants have not been easy across the world. It was after many failed attempts in other countries that a team of Swedish doctors headed by Mats Brännström successfully carried out the first uterine transplantation procedure from living donors in 2013. He referred to uterine transplantation operations as being a “dangerous escapade of surgical cowboys”. A recent article in the Indian Journal of Medical Ethics (IJME) on uterine transplants points out that among all the 25 surgeries conducted worldwide, only nine have been successful and a total of six children have been born through the procedure. For this reason, and for the fact that the biomedical industry in India is notorious for its lack of regulation, it is necessary to discuss these issues.

Human organ transplants are meant for therapy

So how did the Pune hospital go ahead with the operations? According to the THOTA, only therapeutic transplants are permissible and granting approvals for the transplantation of heart, kidney and liver is the responsibility of the state authorities, except for a few states where the Centre legislates on such matters. On the issue of uterus transplants raised in the parliament, the government replied that it is the responsibility of state appropriate authorities, appointed by the state government, to register institutions for transplants including for uterus. This should be done after following the procedures laid down in the THOTA. The authorities are also expected to monitor activities and protocols and maintain data.

The state of Maharashtra follows the guidelines around the THOTA. The uterine transplants carried out in the Pune hospital received clearances from the department of health services, Maharashtra. However, given that uterine transplantation procedures are still experimental in nature and trials are still underway in most parts of the world, it is striking that the Pune-based hospital team went ahead and carried out the procedure as a “therapy”.

There appears to be no rule in the THOTA that clearly says that a therapeutic transplant operation cannot be carried out unless and until clinical trials for it are conducted. Of course, one may ask whether such a rule has to be laid down in the first place when it seems to be a matter of common sense. Nevertheless, it does seem like this would be needed in India given that something strikingly similar happened with stem cell therapy back in the mid-2000s: Clinics were offering stem cell therapy even while there was insufficient research indicating its efficacy.

In reply to our RTI queries, Maharashtra’s department of health services released an inspection report that was prepared by a committee of medical doctors who conducted an inspection of the clinic to ensure that necessary medical, legal and surgical infrastructure is in place to carry out the uterine transplantation procedure. As per the report, the committee appeared satisfied with the facilities extant in the hospital. However, the report mentions a team of experts from Sweden as being responsible for conducting the operation, and not the Indian team of doctors. Media reports following the conduct of the transplants appear to suggest otherwise, crediting Shailesh Puntambekar and his team for the operations.

The inspection committee report also carries lose, unsubstantiated statements such as “the team in Galaxy hospital has three months training in the procedure” and that “effects of immunosuppression on the fetus was studied and was not found to be significant”. Furthermore, it is not clear what kind of informed consent was taken from the stakeholders and if there was any deliberation on what should constitute informed consent for a new procedure such as this – all that is mentioned being that “informed consent from the donor and recipient were available”.

Biomedical research is meant for when there’s no alternative procedure

As for the so called “clinical trials” to be conducted in the Milan Fertility Clinic in Bangalore, another recent RTI query filed to the ICMR reveals lacunae in the approval granted for the trial operations to be conducted here.

The ICMR’s own guidelines on biomedical research on human participants (2006) state that such experiments should be carried out only if they benefit the transplant recipient, without causing risks to the donor and further, that they should be carried out only if alternative procedures are not available to address the problem. The guidelines also state that only renewable tissues should be transplanted, which do not greatly alter physiological functions. Uterine transplants would not fall within these categories – alternative procedures are available to address the problem and the operation is known to pose severe risks to the donor. The trials of uterus transplant are not covered in schedule Y, so it is quite a different issue here from how trials for other molecules or devices are carried out.

As per the replies from the RTI, the ICMR relied on the institutional ethics committee set up by the fertility clinic to review the protocols. Further, the RTI sought information on how informed consent was obtained and what directions the ICMR had provided to the investigators in this regard. The answer simply stated that it is the responsibility of the ethics committee and should be subject to the guidelines of the Drug Controller General of India (DCGI) raising the question of how DCGI guidelines would be applicable to a transplant procedure.

Why has the ICMR refrained from laying down specific guidelines to regulate uterine transplantation? In fact, Banerjee also asked the parliament in August if “hospitals or research centres need permission from the ICMR” with regards to uterus and heart transplants. The health ministry replied, “Permission for organ transplant is not required from Indian Council of Medical Research.”

Thus, from the discussion of both the cases above, it is clear that the concerned authorities have been lackadaisical about drafting regulatory guidelines for this new and controversial transplant procedure. Uterine transplants would need to be evaluated both as an Assisted Reproductive Technology as well as an organ transplant procedure. As of now, it is slipping through the regulatory framework on both counts.

As many commentators have pointed out, the regulatory frameworks that govern biomedical technologies in India mostly consist of guidelines and lack statutory power. For these reasons, it becomes easy for practitioners to bend the rules. Uterus transplants are contentious procedures fraught with ethical dilemmas and many countries after extensive debate have curbed the performance of this procedure.

Sarojini Nadimpally and Aswathi Raveendran are public health researchers working on biotechnologies, drug research and ethics and are associated with Sama Resource Group for Women and Health.