On July 14, an alleged kidney racket was busted in Mumbai's LH Hiranandani Hospital as the police arrested four people, including touts and one transplant recipient. The modus operandi of the Mumbai operation seems similar to a kidney racket unearthed in June at Delhi's Indraprastha Apollo Hospital in which 10 people were arrested. Dr Amar Jesani, editor of the Indian Journal of Medical Ethics, poses questions about investigations into such cases and the responsibility of all institutions that are supposed to regulate transplantation in country as under the Transplantation of Human Organs and Tissues Act, 2011 and Rules 2014.
The recent reports of violations of law related to organ donation are from two large private hospitals. As per the law, in hospitals conducting more than 25 transplants in a year, the hospitals’ authorisation committees should regulate all transplants involving unrelated individuals and donations from foreigners. When the donors are Indian blood relatives of the patient, authorisation should be given by the hospital. In large hospitals transplant co-coordinators may also be appointed.
The hospital requires registration with a nodal agency established for the purpose for organ retrieval as well as transplantation. A cursory reading of the law and rules would show that the hospital has a critical responsibility to ensure that authorisation provided in case of related donors is above board and the authorisation committees function efficiently and independently.
It seems that law enforcement authorities, which found out about the illegality independent of the hospital and concerned authorisation committee, are treating these institutions with kid gloves. Surprisingly, the records of such reported transplants in the hospital and with the authorisation committee are not sealed, and no attempt is made to investigate whether the cases discovered are only a tip of the iceberg.
In order to investigate whether more such cases have happened in the hospital, the police and/or nodal agencies need to review all transplant cases for at least the last one year. The police should also seek medical audits of transplant units and the regulatory audit of the authorisation committees.
Conflict of interest
Commercial hospitals have interest in expanding their business and profits, and so there is always a possibility that many have allowed illegal transplantation for a long time. There indeed is deep-seated conflict of interest between business and their regulation of the law and adhering to ethical practices.
The hospital authorisation committee is chaired by the hospital’s administrator or a doctor appointed by the hospital. Its members include a government representative, two senior doctors of the hospital and two outsiders (non-medical professional, civil society person or others). They are supposed to work independent of the hospital’s business interests and for implementation of law and prevention of exploitation of donors.
So why are only doctors performing organ retrieval and transplantation being questioned, and that also also reluctantly, while hospital administrations and committees not being held accountable? With the hospital nominee as the chair of the committee, there is severe conflict of interest as chair often influences the decision making. Besides, the committee functions in the hospital and is financed by it. Such composition of the committee is a lacuna in the law and is ethically flawed.
Is the functioning of an authorisation committee transparent? Not at all. I have been unable to find, on the website of those hospitals, the names of members of their committees, their background, how many meetings they attended, what kind of decisions they took. There is no information available on the Standard Operating Procedure used by the committees.
In the recent cases in Delhi and Mumbai, neither the hospital that authorised transplantation between living relatives nor the authorisation committee discovered the racket. The crime was brought to light by an informant tipping the police off. This is not new. In case of unethical and illegal clinical trials by the pharma companies in hospitals too, neither hospitals not their ethics committees blew the whistle. Instead, the illegalities were discovered by civil society organisations and the media.
Nodal authority acting like a post office
As per the Transplantation of Human Organs and Tissues Act, there are district, state and national committees that also act as regulatory agencies in addition to hospital administrations and their authorisation committees. Hospitals performing transplantation procedures must be registered with the National Organ Tissue Transplant Organisation.
It is questionable whether this national organisation is ensuring that people appointed to authorisation committees function independently and carry out their responsibilities competently. Is NOTTO checking whether committee members are trained for the tasks they are entrusted to do?
These regulators cannot act just like a post office. Instead they must undertake systematic medical and regulatory audits of institutions registered with them.
If hospitals and committees authorising organ transplantations are not brought into the ambit of investigation, then there seems to be little use of passing a law for regulation of organ transplantation. Unless this changes, there is nothing to prevent such crimes from happening again. Unfortunately, we are looking at the criminals rather than the crime itself, having knee-jerk reaction instead of setting up efficient and competent system for the implementation of law.