The Tamil Nadu government's order issuing guidelines to check the rampant kidney trade in the State is seen as adding to the existing problem instead of offering an effective solution.
in ChennaiTHE Tamil Nadu government has come out with "new guidelines" to deal with the "problem" of a thriving kidney trade in the State. But the guidelines appear to deal with symptoms rather than the disease.
The October 29, 2003 Government Order - (MS) No. 341 of the Health Department - seeks to streamline the implementation of the Transplantation of Human Organs Act (THOA) 1994, which intended "to provide for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs". The THOA establishes an institutional structure to authorise and regulate human organ transplants and to register hospitals that can perform the surgery. It recognises, for the first time in Indian law, the concept of brain-stem death, thus paving the way for a programme of organ harvesting from cadavers. It makes kidney-for-cash transactions a criminal offence and vests the monitoring mechanism with two institutions - the Appropriate Authority to regulate hospitals involved in kidney transplantation and the Authorisation Committee to prevent commercialisation of human organs.
The G.O. and the ensuing guidelines may not live up to the aims of the THOA because the proposals seem not only to burden hospitals unfairly but also to punish them severely - by revoking their licence - for non-compliance by the donors and recipients of kidneys. For example, the private hospitals authorised to perform kidney transplantations are required to produce the donors before the Authorisation Committee one to three months after the surgery for assessment of their well-being. According to a senior Chennai-based nephrologist, many recipients and donors come from as far away as Bihar, Uttar Pradesh and the northeastern States and go back to their hometowns after the surgery. "In such a case, how can a hospital in Chennai which performed the surgery be responsible for bringing the donor to the Authorisation Committee one to three months after the surgery?" he asks.
Another proposal is that the donors from outside Tamil Nadu must get a letter of approval from the Authorisation Committee in their States. But 14 State governments have not set up any such committees. Asks Dr. Chakko K. Jacob, Professor and Head of the Department of Nephrology at Christian Medical College and Hospitals (CMCH), Vellore: "If there is an Authorisation Committee in their own State, why would they want to come to Tamil Nadu for approval?" Two of the unrelated cases (the donor-recipient pair were related but not by blood), hailing from Chittoor in Andhra Pradesh and Uganda, and sent by the CMCH for approval to the Committee at Chennai, were not approved on these grounds.
The most retrograde guideline is the one that requires Human Leukocyte Antigens (HLA) matching (done to establish tissue compatibility) to be conducted "in laboratories not attached to the hospital." This is grossly unfair to hospitals such as the CMCH, which has one of the best HLA matching laboratories in the country. Asks a senior nephrologist: "Is it not possible for patients to influence laboratories outside the hospital?" According to Dr. Chakko Jacob, the CMCH's HLA laboratory was set up by Dr. Paul Terakasi, a world leader in the area who is consulted on almost every test done in the laboratory. Then why should the CMCH conduct its HLA test outside and not in its own laboratory that is one of the best in the country?" he asks.
The main problem with the new guidelines, according to a senior nephrologist, is that it "paints all doctors and hospitals with the same brush," assuming that "everyone is out to dupe the Authorisation Committee", and has not looked at kidney commerce in its entirety. For example, it is silent on the failure of the Appropriate Authority to monitor effectively the approved hospitals, in some of which "bought kidneys" are routinely being transplanted into patients with the Authorisation Committee's approval. Instead, the onus will now be on the donors - or the poor "sellers" as in most cases - and the hospitals to streamline the implementation of the THOA.
Among the other streamlining measures are the verification of the identity and nativity of the donors and recipients given by the approved hospitals with the help of "approved photo identity document" and third party verification. The government also plans to conduct surprise checks on approved hospitals and enforce measures to see that the hospitals send to the Authorisation Committee monthly reports on the number of transplants done by them as mandated by law.
According to Tamil Nadu Health Secretary Sheela Rani Chunkath, the new guidelines are part of the measures being taken to end the kidney trade. She warns that stringent action will be taken against anyone violating the law. The Health Department is also planning a multi-media awareness campaign on the medical, legal and social aspects of kidney transplantation.
Yet, nothing seems to have been done about the police cases (relating to middlemen allegedly cheating donors of the promised price for their kidneys) that reveal a nexus among donors, agents, hospitals and recipients. Not one hospital's licence has been cancelled, though media investigations have revealed monetary consideration to be involved in several unrelated transplantation cases that have gone through the Authorisation Committee.
For example, though media investigations have pointed to the involvement of monetary transaction between some donors and recipients through middlemen in the Chennai-based Devaki Hospital, neither the Appropriate Authority nor the Authorisation Committee did anything about it. But now, following a complaint (allegedly to settle personal scores) by a Devaki Hospital managing committee member, Chitra Chokalingam, regarding irregularities in the hospital's unrelated human organ transplant programme, the licence of the hospital has not been renewed ( it has to be renewed every five years) and an inquiry is being ordered.
According to a recent study, "Implementation of THOA", by Dr. V.R. Muraleedharan and S. Ram Prasad of the Centre for Sustainable Development, Indian Institute of Technology, Chennai, "the commercialisation of kidneys is as common now as it was before the implementation of the Act and the present regulatory system is incapable of preventing it". The study says the loophole in the Act is Section 9(3), which allows kidney donation on grounds of "affection and attachment", and is therefore much exploited for the trade in kidneys. For instance, the study notes that it is not uncommon to find end-stage renal disease (ESRD) patients marrying women for their kidney and then divorcing them; getting the approval of the Authorisation Committee using a proxy donor; doing unrelated transplants without the approval of the Authorisation Committee; and providing false addresses for the donors. The major problem, notes the study, is that the Authorisation Committee is required to give reasons for rejecting an unrelated donation but not for approving it.
The IIT study also takes note of the strong hospital-middleman nexus. "Several medical professionals and hospitals have unabashedly allowed middlemen to operate in their own premises and thus have allowed commercialisation of kidneys to boom," it says. "Such unhealthy practices motivated by financial considerations have also led to the dilution of medical norms for matching compatibility of donors and recipients," the report notes, and adds that "many of the donors, in fact, are of poor health and should never have been allowed to donate a kidney."
According to another study (Economic and Health Consequences of Selling a Kidney in India by Goyal M. et al) published in the Journal of American Medical Association in October 2002, as many as 305 people from Villivakkam in suburban Chennai, have sold their kidneys. Thereafter, their income has declined by 67 per cent; 75 per cent of them are still in debt; and the health of 83 per cent of them has deteriorated.
Yet, the Authorisation Committee is "unable to find proof" of any "kidney sale" in Chennai. A former Chairman of the Authorisation Committee, Dr. C. Ravindranath, admits that the Committee is aware of the kidney racket in the State but does not know how to get proof. This plea of helplessness is hardly convincing considering that a host of foreign television channels (such as Ekoch FilmProduktion from Germany and Kurtis Film from the United States) have extensive footage of, and interviews with, donors, brokers, recipients and even doctors relating to the thriving kidney trade in Chennai.
In the "absence of proof of kidney commerce in the State", the Tamil Nadu G.O. aims to streamline the Authorisation Committee's working and make the procedures easier for potential recipients and unrelated donors in remote areas of Tamil Nadu by setting up two Authorisation Committee centres in Madurai and Coimbatore. Also, as 15-20 cases come before the committee for approval every week (it meets once a week at the Government General Hospital, Chennai) and "it is very difficult to verify the authenticity of each case", the G.O. seeks the help of third party non-governmental organisations (NGOs) to verify the information given by each set of recipient-donor.
However, on account of the alleged fall in the number of cases coming up before the Authorisation Committee after the G.O. was passed, the government has decided to put on hold its proposal for setting up committees in Coimbatore and Madurai.
According to Dr. Ravindranath, there are 45 approved transplant centres in the State, of which 28 are in Chennai. The committee meets once a week and considers some 30 applications (allegedly come down by half since January 2004). "It is impossible to verify the claims in each case and it is difficult to establish if money is involved in every donation," he says.
Dr. M.K. Mani of Apollo Hospitals, Chennai, a strident voice against live unrelated donations, says that the job of the Authorisation Committee is to prevent commercial deals in organs, as mandated by law. If it is unable to do so, then there is every reason to scrap Section 9(3), which allows for live unrelated donations on emotional grounds. According to him, every live unrelated kidney donation is bound to be commercial in nature and exploitative of the poor. The recent government measures will hardly solve the problem of kidney commerce in the State, he says.
"An example of an Act not intended to be implemented is the Transplantation of Human Organs Act, 1994," says Keshava Rao, Professor, National Law School of India University, Bangalore. He says three petitions that seek to scrap Section 9(3) are pending before the Supreme Court.
According to Dr. Sunil Shroff of the Sri Ramachandra Medical College and Hospitals, Chennai, the kidney trade not only exploits the poor, but also effectively suppresses a cadaver programme. Ironically, it is to cater to fewer than 3 per cent of the patients who need kidneys (while 97 per cent of ESRD patients die unable to afford dialysis or a transplant) that such an exploitative system is being sustained.
The IIT report also notes that the government has done little to promote a cadaver programme. There is no functional organ registry; several cadaver organs go waste; and there are not enough doctors approved to certify brain death.
According to Dr. Shroff, organ donation takes place in hardly 19 per cent of brain-stem death cases. This is because of many problems, including a shortage of approved specialists to certify brain-stem death and lack of facilities to reach trauma patients to hospitals in time to harvest organs. "If the government really wants to help ESRD patients, it should take measures to address these problems and put a cadaver programme in place," he says. But according to Dr. Mani, a preventive care programme focussing on diabetes and blood pressure, the main causes of ESRD, is the best long-term solution.
A senior nephrologist, talking on condition of anonymity, said that if the government was serious about cleaning up the system and ending kidney commerce, it must first bring transparency to the functioning of the Appropriate Authority and the Authorisation Committee, and make them accountable and responsible for every decision taken. Secondly, it must break the donor-broker-doctor-hospital nexus. "It can," he says, "begin by asking why less than 5 per cent of the cases that come before the Authorisation Committee are rejected when monetary consideration seems to be involved in most of the cases, and why, while over 11,000 live kidney transplants have been done in the country since the enforcement of THOA, only 500 are from cadavers."
COMMents
SHARE