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Dhanwantari narrates: “During the great war of the gods, Rudra severed the head of Yadnya. The gods then approached the famous celestial twin surgeons, Aswinikumaras. They successfully united Yadnya’s head to his trunk restoring him to life” This is how it started.
What is organ transplantation?An organ transplant is a surgical operation where a failing or damaged organ in the human body is removed and replaced with a new one. An organ is a mass of specialized cells and tissues that work together to perform a function in the body. The heart is an example of an organ. It is made up of tissues and cells that all work together to perform the function of pumping blood through the human body. Any part of the body that performs a specialized function is an organ. Therefore eyes are organs because their specialized function is to see, skin is an organ because its function is to protect and regulate the body, and the liver is an organ that functions to remove waste from the blood.
Organ transplantation has been part of medical technology for over forty years, beginning in the 1950s with the first consistent successes in kidney transplantation. Recent advances in technology which are advancing the frontiers of transplantation dramatically, however, are now poised to combine with another powerful force–that of free markets–to impel society to confront the mechanism by which providers and users of human organs are brought together. Inside the human body, there are twenty-five different organs and tissues that can be transplanted under current technology, including bone, bone cartilage, bone marrow, corneas, heart, kidneys, intestines, lungs, and livers. Organ transplantation is not some sort of experimental new science. Success rates for such surgeries are as high as 95+%; and for many diseases, a transplant is the standard method of treatment.
Theme of the projectImagine that a member of your family faced sure death unless a body part could be found and quickly transplanted. Your doctor and the hospital have the know-how to perform the procedure but lack the human raw materials with which to do the job. To what lengths sure you be able to go to obtain the body part? And, since the supply is usually smaller than the demand, who should decide who gets the human organ and on what basis? Should a free market be allowed? Whether this matter requires a national standard that reconcile between centre and state government regulations? What about “equity” and ability to pay? Should body parts be provided regardless of wealth? What is the effectiveness of the regulatory legislations for Human Organ Transplantation? This article examines those questions in relation to public interest and critically analyses the regulations in relation to Human Organs Transplantation in India.
Human Organs Transplantation: Indian PositionEthical Issues
The ethics of transplantation can be expressed in three requirements:
1. Medical integrity: Patients and the public must be able to trust their doctors not to sacrifice the interest of one to that of another. Individual may make that sacrifice, but not their doctors.
2. Scientific validity: the basic biology and technology must be sufficiently assured to offer a probability of beneficial outcome, case by case.
3. Consent: Consent based upon information adequately presented, weighted and understood, and unforced.
There are certain ethical principles evolved to suggest that transplantation would be within the bounds of ethics if certain criteria are fulfilled, in instances of living donor transplantation. These are :
1. The removal of the tissue or organ does not impair the health or functional integrity of the donor.
2. The benefits expected to be given to the recipient bear an acceptable proportion to the harm likely to the donor.
3. The donation should be altruistic and is given without any coercion or any other form of external pressure.
4. The donor must be fully informed of the nature of the procedure and the possible — even if rare — complications. This entails the need for follow-up of the donor’s health in the future.
5. The views of close relatives such as the spouse or adult children are taken into account.
6. There must be no element of commercialisation or exploitation in the donation.
The practice of medicine is largely unregulated in India. Medical councils and organisations have played a passive role on ethical issues. They have failed to make their stand public or take action even in obvious malpractice. Although the press has been publishing explicit details on rackets in kidney transplantation in various cities no medical body has thought it fit to even conduct an investigation into them.
State medical councils have suo moto powers of investigation. These have never been invoked. The councils have also turned a blind eye to complaints lodged with them. Dr. C.Nanjappa, president of the Karnataka Medical Council, admitted that complaints against the accused in the Bangalore scam had been received in 1993 . All that the council had done was to ‘note’ that the behaviour of the doctors who appeared before them was ‘suspicious’. With a population that is largely illiterate and gullible, such attitudes by disciplinary agencies have nurtured a fertile ground for racketeering.
There are many who believe that transplantation represents one of the most spectacular achievements of modern medical science. Advances from many fields of medicine have contributed to a tremendous improvement in results over the decades. This has lead to a steep rise in the numbers of transplants being performed. Transplantation has also raised some of the fiercest ethical controversies in modern medicine. In a way it is not surprising that a field which involves the removal of human organs from a living or dead individual to save the life of another individual should throw up strange ethical dilemmas. Perhaps no other field of medicine has raised so many complexes and intertwined ethical, moral, legal and social issues. Even from the Indian perspective the 'kidney bazaar' as it was rather crudely but aptly termed remains one of the biggest ethical controversies to hit the public domain in the last decade.
With the increased inflow of personnel and knowledge from the developed world transplantation of organs is being attempted in increasing numbers in India. Simultaneously with the introduction of a specific act called the Transplantation of Human Organs Act (HOTA) in 1994, the way has also been paved for performing 'cadaver' transplants from 'brain dead' patients. The Act, which was partially a response to the public outcry about the 'organ trade' in the early 90's, is also meant to monitor organ trading. Reports from the field indicate that the act has not really succeeded in achieving its main objectives, namely, to promote cadaver transplantation and to curb trading in organs.
Our country has an enormous and ever increasing pool of patients with end stage liver disease for whom the only therapy available is liver transplantation. In the absence of any other therapy, an overwhelming majority of them die and only a handful manages to get timely transplants. Though liver transplantation is technically very demanding, there are a large number of surgeons and other health care professionals trained in liver transplantation in India. However, this procedure is performed in only about 10 centres in India with their total experience amounting to about 250 liver transplants. Heart and lung transplantations, either individually or in combination, are being performed in India since the first successful heart transplant done in 1994, but their cumulative numbers can be counted on finger tips. The basic reason for these organ transplant procedures not taking off on a large scale is the absence of a viable cadaver donor programme. Evidence for this stems from the knowledge that a lion’s share of liver grafts in Indian centres come from live relatives and such live donation is not possible for heart and lung transplants, and hence their small numbers. The first successful combined renal and pancreatic transplantation has recently been performed in India, though more than 800 such transplants are performed yearly in the USA alone. The obvious conclusion is that unless we have a viable cadaver transplant programme, we will stay routed to where we are now. When the world is rejoicing over the success of the first facial transplantation, Indians can only dream of it.
Before looking at the Indian Regulatory framework, it is considerable to have the global scene. Table 1 shows the major Legislation, practice and donor rates with regard to human organ transplantation, around the world.
|Country - Legislation||Actual practice||Donors (pmp) annual rate 2003|
|Spain - Presumed consent||Informed consent||33.8|
|Belgium - Presumed consent||Presumed consent & family informed||24.4|
|Austria - Presumed consent||Presumed consent||23.3|
|US - Informed consent with required request||Informed consent with required request||22.1|
|Ireland - Informed consent||Informed consent||21.1|
|Norway - Presumed consent||Presumed consent||19.2|
|France - Presumed consent||Presumed consent||18.3|
|Netherlands - Informed consent||Informed consent||14.9|
|Germany - Informed consent||Informed consent||13.8|
|Sweden - Presumed consent||Varies, recent changes||12.8|
|UK - Informed consent||Informed consent||12.0|
|Greece - Presumed consent||Informed consent||6.4|
Source: Council of Europe; National Transplant Organisation (ONT)
Salient Features of HOTA, 19941. The Transplantation of Human Organs Act, 1994 is meant 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 Central Act illegalises the buying and selling of human organs and makes cash-for-kidney transactions a criminal offence.
2. The law establishes an institutional structure to authorise and regulate human organ transplants and to register and regulate, through regular checks, hospitals that are permitted to perform transplants.
3. It recognises, for the first time in India, the concept of brain-stem death, paving the way for a cadaver-based kidney transplant programme.
4. The Act details actions that amount to direct participation in or abetment of the organ trade; these offences are punishable under Section 19 of the Act.
5. The Act defines two categories of donors:-
• First, it permits a near relative, defined as a patient's spouse, parents, siblings, and children, to donate a kidney to the patient.
• Secondly, in Section 9(3) of the Act, live donors who are not near relatives but are willing to donate kidneys to the recipients “by reason of affection or attachment towards the recipient or for any other special reasons,” are permitted to do so, provided that the transplantations have the approval of the Authorisation Committee, established under the Act.
6. The Act makes the offence of kidney trading non-cognisable. In other words, the police cannot look into complaints of kidney trading independently but must wait for a complaint to be made by the Appropriate Authority set up under the Act or by an officer authorised by it or by an individual who has given prior notice of not less than 60 days to the Appropriate Authority.
7. It is not clear whether Section 9(3) was deliberately meant - under pressure from special interests - to provide a loophole that could be exploited in practice, or whether the law-makers thought they were sympathetically making provision for donations from second-degree relatives and others who might act out of genuine love and affection or altruism. But whatever be the reasoning and motivation behind the provision of a loophole, the practical operation of Section 9(3), combining with the non-cognisability of the offences to be prosecuted, has rendered the 1994 Act virtually unenforceable.
8. The Act very sensibly provides for registration of hospitals claiming to have the necessary competence and facilities to perform particular organ transplantation. This is a regulatory measure intended to protect the interests of patients. It is with the Appropriate Authority, set up by the State government under the Act, that hospitals intending to do transplants must register. Approvals are granted only after the institutions fulfill certain technical, infrastructural and medical requirements.
Critical Analysis Of HOTA, 1994Due to various scam and sting operations being reported in the news, and prosecution of medical professionals thereupon in such cases, the medical fraternity is scared of granting permission for donation of human organs on one ground or another. Those cases that are refused permission go to the courts for justice. There is a delayed procedure in the courts and many times such cases get death earlier than the verdict. All this needs a critical evaluation that whether the act is serving the purpose for which it was enacted or it is the hindrance in a noble cause of donation of human organs.
Most of the reputed institutions have made it a policy that they will operate upon on only those cases where the donor is near relative i.e. spouse, son, daughter, father, mother, brother or sister; and permission of the authorization committee to donate the organ and operation is not required.
Due to the fact that many medical professionals have been caught unaware because they did not knew the intricacies of law. They were supposed to check the affidavits whether they were genuine or not. Without any training for such purposes obviously they relied upon these documents and when these documents turned out to be fake, the axe of law fall on them. They were supposed to find the genuineness of the donor without any investigative powers with them. But keeping in mind the urgency of the situations they took decisions and made judgments which in a few cases turned out to be wrong.
After the cases were made out against medical professional the entire medical profession got scared. Then the authorization committees felt that they have to be cautious to save themselves from inadvertent passionate wrong decisions. In this process they became overcautious and in the process of verifying all the documents it started taking a long time.
Medical professionals were in a dilemma that they had taken a solemn oath they will try to save the life of the patient by all means. When they were sitting in such committees they were not trying to save the life of critically ill patients of renal failure but trying to rule out that there is no monetary involvement in these organ donations. They were at great pains, when they had to deny permission as now they were not trying to save the life of the patient but were just acting contrary to it.
To lessen this burden on the conscious of medical profession it was suggested that some senior police officer and some revenue officer should be the member of such authorization committees. Police officers will be able to establish the identity of the donor as they had investigative teams with them. They will be able to rule out the monetary transaction. Revenue authorities could verify the affidavits so they were made members.
After the introduction of these members it was thought that the process will become simpler and it will take less time. But it was a general feeling that this is a tricky situations and nobody wanted to take onus for decisions and waiting time for the renal failure patients did not decrease.
As the donors were mostly from a different state than the recipient, a question arose that which of the authorization committee will give permission for donation, whether the committee where the recipient is living, donor is living or where the patient is getting operated. Appropriate authority took the decision that authorization committee of the place, where the hospital carrying out renal transplantation is situated, will take the decision.
This raised a problem of verifying the persons from very distant places. Papers were sent back to the different states for verifying the antecedents of the donors and recipients. This process took a lot of time. During this time patients, many a times became more critical. Appeal in such cases against the decision of the authorization committee, was with appropriate authority. They were also medical professionals and they had the same dilemma as members of the authorization committees. They also could not expedite the process of quick decisions. After this appeal lied with the Central Government where the appeal is against the order of the Authorisation Committee constituted under clause (a) of sub-section (4) of Section 9 or against the order of the Appropriate Authority appointed under sub-section (1) of Section 13; or the State Government, where the appeal is against the order of the Authorisation Committee constituted under clause (b) of sub-section (4) of Section 9 or against the order of the Appropriate Authority appointed under sub-section (2) of Section 13 of HOTA-94.
Many patients went to the courts for getting quicker decisions regarding permission for organ transplantation. But courts have also their own lengthy procedures and sometimes they got the death call earlier than the verdicts from the courts.
To expedite the process now Deputy Commissioners, who were earlier members of the committees had now been made the chairman of the authorization committees in Punjab and there is one medical professional as a member along with Senior superintendent of police and member of NGO.
The purpose of the Human Organ Transplantation Act was 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 and for matters connected therewith or incidental thereto. “Donor” means any person, not less than eighteen years of age, who voluntarily authorizes the removal of any of his human organs for therapeutic purposes. “Human organ” means any part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body; therapeutic purposes” means systematic treatment of any disease or the measures to improve health according to any particular method or modality; and “transplantation” means the grafting of any human organ from any living person or deceased person to some other living person for therapeutic purposes.
Where the body of a person has been sent for post-mortem examination for medico-legal purposes by reason of the death of such person having been caused by accident or any other unnatural cause; or for pathological purposes, the person competent under this Act to give authority for the removal of any human organ from such dead body may, if he has reason to believe that such human organ will not be required for the purpose for which such body has been sent for post-mortem examination, authorize the removal, for therapeutic purposes, of that human organ of the deceased person provided that he is satisfied that the deceased person had not expressed, before his death, any objection to any of his human organs being used, for therapeutic purposes after his death or, where he had granted an authority for the use of any of his human organs for therapeutic purposes after his death, such authority had not been revoked by him before his death.
No registered medical practitioner shall undertake the removal or transplantation of any human organ unless he has explained, in such manner as may be prescribed, all possible effects, complications and hazards connected with the removal and transplantation to the donor and the recipient respectively. It has been observed that most of the times surgeons involved in organ transplantation do not tell exactly what is needed to be told and just explain it is a simple operation and they need not be afraid. This is not a good practice. It is the need of the hour that donor is told clearly as per the law so that later on donor does not feel cheated. Any person who renders his services to or any hospital and who, for purposes of transplantation, conducts, associates with, or help in any manner in, the removal of any human organ without authority, shall be punishable with imprisonment for a term which may extend to five years and with fine which may extend to ten thousand rupees. Where any person convicted under sub-section (1) is a registered medical practitioner, his name shall be reported by the Appropriate Authority to the respective State Medical Council for taking necessary action including the removal of his name from the register of the Council for a period of two years for the first offence and permanently for the subsequent offence.
In western countries organ donation is mostly from the brain dead persons but in India this phenomenon has not picked up. It has been seen that poor persons posing as servants of the person and showing attachment due to love and affection to their masters, are the donors mostly. It becomes very difficult to rule out involvement of money in such cases. Many times donors give wrong affidavits that they are not accepting money when the situation points otherwise. People should be made aware that organ donation after death can save the life of many patients. Procedure for organ donation after death should be made simpler. People who want to donate organs may be issued cards like driving licenses which can be kept in their pockets. To make it more simpler consent for organ donation may be entered on the driving licenses of the donors. Organs then may be removed as early as possible from dead bodies of such persons without any further legal formalities. Organ banks may be started in good hospitals and may be given to the needy patients as per the waiting list of that state or a particular area.
The Transplantation of Human Organs (HOTA) Act, passed in 1994, was a significant step towards regulating transplantation of human organs and preventing commercial dealings in human organs.
The Centre is in the process of modifying the Transplantation of Human Organs Act, 1994, to bridge the huge gap in the requirement and availability of human organs for transplantation. Maintaining the present ethical guidelines, the Act would be modified to simplify the procedures involved in transplantation, Union Health Minister Anbumani Ramadoss. said at the 54th annual conference of Tamil Nadu Ophthalmic Association at JIPMER that “The Act would be self-regulatory” and special emphasis would be given in the Act to expand the scope of eye donation, which at present was not satisfactory. The country needs around 1 lakh eyes for transplantation but every year only 25,000 eyes were available. More eye banks, including facility to store cadaver eyes, would be opened in all parts of the country. One such bank had already been opened in Delhi.
The limitations which need to be amended to serve the purpose for which the Act covers following:
• Chapter III, clause 10 section 1 (a and b) need modification. The Act mentions that no hospital, unless registered under the Act, shall conduct or associate with or help in the removal or transplantation of human organs. Similarly, the Act mentions that no medical practitioner shall conduct or aid in conducting any activity relating to removal or transplantation of human organ at a place other than a place registered under the Act. Here, there is need for an amendment.
For example, there may be a suitable cadaver donor at a medical centre not registered under this act. The family members of such a cadaver donor may wish to donate organ(s). To be able to do this, they would have to transfer the cadaver to a hospital registered under the TOHO Act. This would subject them to unnecessary inconvenience. It may be noted that removing organs does not require elaborate facilities and infrastructure.
Organ transplantation can also be encouraged by permitting medical practitioners from a hospital registered under this Act, to remove organs from a cadaver, with the consent of the family, maintained at a medical centre not registered under this Act. To curb any misuse, it may be made mandatory to obtain prior permission from the chairperson of the authorisation committee/appropriate authority.
This practice of removing organ(s) from cadaver donors at peripheral centres, not recognised for transplantation, is already prevailing in all countries following an active cadaver transplant program.
For example, a person may sustain severe head injury in a road traffic accident near Panvel. He is taken to a nearby hospital, say, Reliance Hospital where, on investigation, he is found to be brain-dead. However, if the family is educated and wants to donate the organs, they would have to transfer their loved one to a hospital registered under the Act (e.g Hinduja Hospital at Mahim). The inconvenience of transferring, the cost involved, and the possibility that instability during transfer may make the cadaver unsuitable, is sufficient to make them drop the idea of donating organs.
In such a situation, a team from Hinduja Hospital can go to Reliance Hospital and remove the organs. With the present Act, only those sustaining brain death in registered hospitals (currently there are only 13 registered hospitals in Mumbai), could be potential cadaver donors. If the Act is amended as suggested, cadavers from a number of hospitals in and around Mumbai could be donors and thousands of people with end-stage organ disease would benefit from transplantation.
• In the opinion of some doctors, brain death is death only in the context of organ transplantation. Thus, if the family of the brain-dead patient does not consent to organ donation, the doctors are unwilling to declare death and discontinue the ventilator to hand over the body to the family. This creates confusion in the mind of the family because, on one hand the doctors say that the patient is dead and on the other hand, they refuse to discontinue ventilator and hand over the body.
In my opinion, the definition of death cannot be different in different contexts. If a person is dead and his organs, including the lungs and the heart, can be removed (if the family consents to donate organs), there is no reason why he cannot be declared dead (even if the family does not consent organ donation)
It must be realised that, discontinuation of ventilator and other supportive therapy for patients who are brain-dead, is a humane and necessary act, without regard to the possibility of such a person serving as an organ donor.
In view of the confusion in the minds of some doctors, it is suggested that the Act should mention that the ventilator and supportive therapy be discontinued even if the family of brain dead patient does not consent to organ donation. Alternatively, the fact that brain death is death should be included in the general definition of death.
• The Act must make it mandatory for professionals to make a request for organs in the event of brain death. There have been instances where the family has expressed a feeling that they were unaware of organ donation and that, they would have consented had they been explained and requested.
• Since brain-dead cases are often a result of road traffic accident, they are medico-legal cases. These cases would require an autopsy to be conducted. If the death occurs in a private hospital, after removal of organs, the body has to be transferred to a public hospital for an autopsy. This results in a lot of inconvenience for the family of the deceased.
• At times, this deters the family from consenting to organ donation. A system should be developed whereby, the medical officer conducting autopsy at a public hospital, could be present at the time of removal of organs in the private hospital, and conduct the autopsy there itself.
Indian law permits live donation from non-relatives; this is mostly misused for commercial interests. The lacuna in the law was that the screening committee had no mechanism to find out the whereabouts of the donor and whether the donor was truly altruistic. In most cases, the donors were well coached by the middle man before the screening procedure. There is no system in place that can effectively monitor the transplantations. If the organ trade is not controlled, disappearances, especially among street children, violences and baby kidnapping rackets may flourish along with the theft of organs of executed criminals in future. The people may lose trust in the medical community and may suspect their involvement in premature declaration of death on seeing a signed donor card.
Donation of an organ is most altruistic, meaning an act in life to help another human being and reliably change the situation of the latter. Even in the UK, 70% of the people favour organ donation, but only 25% hold donor cards. Data from the Arab world shows that all the 81 renal transplantations conducted during 2001 were cadaveric donations. Selling organs demean human beings; there is always 'the rich who receive and the poor who give'. In India, it is estimated that there are 80,000 people with severe renal failure and 650 dialysis units are available. Our resources are scarce and the needs outstrip these.
A recently published World Health Organization (WHO) document made the following points: Changed economic policies leading to foreign competition in the health service market are reducing the access to care for the poor. It appears that health is a luxury in developing countries. The system of forcing individuals to make out-of-pocket payments for health care denies basic care to the poorest members of the society. The above statement is relevant in the Indian context where there is no social security system and very little public expenditure in the health sector.
Studies have shown that 85% of doctors in India have no training in medical ethics. Teaching, training, following and practising ethics among doctors in our country is the only solution for the unethical medical problems flourishing in our country amidst poverty. We have to uplift the four big values in bioethics: autonomy, beneficence, non-maleficence and distributive justice.
The Transplantation of Human Organs requires proper amendments to suit the need of the hour. The objective of the legislation needs to be expanded to cover the public interest and ethical issues of organ transplantation. It is not only the check on commercialization of organs in issue, the availability and distribution to be covered along with it.
1. Austen Garwod- Gowers, Living Donor Organ Transplantation: Key Legal and ethical issue (1999) Dart Month Publishing Company, England
2. S Mclean, Contemporary Issues in Law, Medicine and ethics (DartMouth Aldrshot, 1996)
3. Stephen Wilknson, Bodies for Sale: Ethic and exploitation in the Human Body trade (Routledge London 2003).
1. Ethics in Organ Transplantation, Center for Bioethics, February 2004.
2. Scott Russell, The Body as Property, (New York: Viking Press, 1981)
3. Dr B N Colabawalla, Issues in Organ Transplantation, IJME Jul-Sep2001-9(3).
4. Sanjay Nagral, Organ transplantation: ethical issues and the Indian scenario, IJME, Apr-Jun2001-9(2)
5. Maj Gen P Madhusoodanan, Organ Transplantation in India: Indian Scenario and Perspectives for the Armed Forces, MJAFI 2007.
6. Transplantation of Human Organs Act to be modified: Anbumani , The Hindu, Sunday, Aug 13, 2006
Journals and Reporters:
1. Journal of Medical Ethics
2. Indian Journal of Medical Ethics
3. Medical Journal of Armed Forces of India
4. American Journal of Law & Medicine
1. Human organs Transplantation Act 1994
Organ Transplantation Law In India:
organ transplantation, and the development of law on the same. It highlights the problems faced in the proper implementation of the organ transplantation program in the Indian scenario, such as poverty, lack of awareness, and loopholes in the law, like the 'affection clause'
Organ Transplantation - Legal, Social And Ethical Issues: Organ transplantation is an issue that must be dealt with sensitivity. Orienting society to accepting the ‘value of life after death' will go a long way in strengthening transplantation as medical treatment.
Organ Transplantation And Its Legal Prospects:
The development and application of technologies will arguably be the major driving force for the evolution of the world society in the first part of our new century. In medicine, agriculture, material science, communication and host of other areas, new technologies promise unimaginable changes in our lives.
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