THE ORGAN TRANSPLANTATION LAW IN INDIA

THE ORGAN TRANSPLANTATION LAW IN INDIA

The transplantation of an organ from one body to another is known as the organ transplant. The person who gives the organ is called the donor while the one who receives is called the recipient. Organ transplant is done to replace the recipient’s damaged organ with the working organ of the donor so that the recipient could function normally.

Organ Transplantation is a boon to medical industry as it has helped in saving the lives of those who would have died otherwise. There is a great need for human organs for transplantation. In fact, the need far exceeds the supply of transplantable organs. This disparity has led to the formulation of various legislations, attempting to regulate the scare resources (transplantable human organs) and to help establish an equitable system to allocate the organs where they can do the most good.

Legally, organ donation can take place from living, genetically-related individuals; from living, unrelated individuals in special circumstances where no unauthorized payment is made to the donor; or from cadavers. Live donation of a single kidney was the first done in 1954, but live donation of parts of other organs is a relatively recent innovation in the 1990s.

To date the major source of organs and tissues in the West has been from cadaveric donors. Living tissue deteriorates rapidly when it loses its blood supply, and organs need to be cooled and transported for implantation into the recipient within a limited number of hours. Short transfer time, entailing removal of organs from ‘beating heart’ donors, was made possible by the acceptance of ‘brain stem death’ as death.

Worldwide, the demand for organs is growing, as the supply of organs and tissues for transplantation has not kept pace with demand. In the UK only approximately 900 individuals become organ donors each year, while over 6000 people are waiting for suitable organs. In the US much the same situation exists, with 70 000 presently on the waiting list and only approximately 5500 cadaveric donors per year.

There are several reasons for the shortage of organs. Perhaps the most common reason is that people are hesitant to donate organs. There are other reasons as well: for example, physicians may neglect to inquire of family members whether they would consent to donating organs when their loved one dies. In other cases, the deceased's wishes to donate his or her organs may not be known by those in the position to act on those wishes.

Presently three major legal frameworks govern the donation of organs worldwide. The UK, along with a number of European countries, e.g. Germany and Italy, and Canada, Australia, and New Zealand have ‘opting-in’ systems. This means that the person in lawful possession of the body may authorize the removal of organs and tissues. In practice donation is usually requested from the next-of-kin of the deceased. Many other countries, including e.g. Austria, Belgium, and Singapore, have introduced ‘opt-out’ or ‘presumed consent’ systems that assume individuals have granted permission for their organs to be donated, unless they specify otherwise, in advance of their death. ‘Required request’ or routine enquiry of the next-of-kin of a potential donor, forms part of state law in the US. It provides for hospitals that fail to adopt ‘required request’ polices to be denied support from healthcare funding agencies.

WHO has now approved organ transplantation as a well established therapy.
A Harvard Medical School committee made a historic proposal in 1968, recommending the criteria of death based on brain activity. In 1976 the Royal College of the UK published a comprehensive code for determination of 'Brain Death'. Now most countries, including India in 1994, redefine death as cessation of brain stem activity and organs can legally be removed after brain death.
In a bid to understand various organ donation policies prevailing in other countries of the world a team of experts headed by R.K.Srivastava, the Director General of Health Services made a visit to all the major countries and noted that most of the countries have adopted the presumed consent method, where the person who is brain dead is considered to have agreed to donate the organs. In other cases, family of the donor holds the right to give the consent.

To attempt to overcome the uncontrollable trade in organs the Indian parliament passed a bill in 1994, in keeping with the WHO guiding principles, prohibiting commercial dealings. There are restrictions for removal and retrieval of human organs and also regulations of hospitals involved to ensure transparency by all concerned. The aim of the Transplantation of Human Organs Act is “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 passing of Transplantation of Human Organ Act heralded a new era in Indian medicine. This legislation was written on similar likes as the UK Transplant Act. The essence of this legislation was threefold:
1. To accept brain death as also a definition of death.
2. To stop commercial dealing in organs
3. To define the first relative (father, mother, brother, sister, son, daughter and wife) who could donate organs without permission from the government.

Organ transplant law does not allow exchange of money between the donor and the recipient. According to the Act, the unrelated donor has to file an affidavit in the court of a magistrate stating that the organ is being donated out of affection. After which the donor has to undergo number of tests before the actual transplant takes place. The Authorization Committee set up for the purpose ensures that all the documents required under the act have been supplied. If it is found that the money has been exchanged in the process then both the recipient as well as the donor are considered as prime offenders under the law.

According to the Indian law, organ sales are banned and therefore no foreigner can get a local donor. Human organ transplant laws are very strict in India and the penalty incurred for organ trade is also very high.

THOA limits live transplants to three categories: relatives by blood, spouses, and those who donated “out of affection”. State authorisation committees are meant to scrutinize all applications for unrelated transplants. Hospitals conducting transplants are supposed to be registered with committees which are also supposed to monitor their functioning.

However, the practice of medicine is largely unregulated here and there are numerous problems regarding proper implementation of the program. Medical councils and organizations 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.

For instance, the Karnataka Medical Council, admitted that complaints against the accused in the Bangalore scam 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.

Also, the diagnosis of brain death is made in ICUs where facilities exist for sustaining the other organ systems of a brain dead patient. Such ICUs are few and are commonly located in big metropolitan hospitals. They are overburdened, understaffed and lack a central command structure. Brain dead patients have traditionally been given low priority in ICUs and treated with benign neglect.

When such patients become donors, they require the same attention as that given to any critically ill patient. This demands a major attitudinal change and could be resented by an already overburdened staff.

The act of obtaining consent is also a hindrance towards successful running of the program. The relatives of the patient are not very forthcoming, and the doctors not motivated enough. Patients may lack relatives or may not have them in attendance when the diagnosis of brain death is made.

In a country where monetary and political considerations are acquiring an ominous hold on the behaviour of the medical profession, the scope for unethical acts in the transplant process is fearsome. In a private sector, where market values and profit making have reached grotesque levels, there could be havoc in a field where cash benefits can be astronomical.

The overall health allocation in our budget is one of the lowest in developing countries. There is scope for an increase in health funding. Resources for advanced medicine need not be provided at the cost of primary care if the state ensures a proper balance. Thousands with endstage disease can be provided a new lease of life through cadaveric transplant programs. Hitherto, only the very rich benefited from transplantation- of organs by travelling abroad and spending large sums. We should make organ transplants affordable by the average citizen in our public institutions.

In various surveys conducted, it has been seen that 72% of the population were willing to donate eyes, but less than 50% were willing to consider solid organ donation. 74% of Hindus, 72% Christians, 58% Muslims were willing to consider organ donation; however the concept of brain death was new to most of the people surveyed. An audit of 159 brain death patients showed that 30 or 19% of the relatives donated of the organs of their loved ones.

In the last 6 years 35 hospitals in the country from various regions have undertaken cadaver transplants. Chennai has done the maximum number of cadaver transplants in the country. However most of them lacked motivated medical or social workers who could be trained to speak to the relatives in brain death situations. In event of the donor not being a first relative an approval had to be obtained by a government appointed authorization committee in each state of the country.

The public attitude survey indicated a positive attitude of the people towards eye donation. After this survey a simple protocol was devised It was suggested that 'Eyes' should be requested for first and only if the relatives were willing other organs requested. The Eye donation activists of the country are already lobbying for a "required request law" in event of a death in a hospital. This is likely to be soon passed by the parliament and be enacted as a law. This same law can be extended for solid organs in a brain death situation. If this is done it can give the required boost to the program and make it obligatory for the hospitals staff to ask for organs.

A major center Sri Ramachandra Research Medical College And Research Center, undertaking cadaver transplants in the last 6 years has had a brain death conversion rate of 19% (30/159). In this institution the ICU staff have been sensitized to the issue of brain death and organ donation.

The number of fatal road traffic accidents every year in India is constantly rising and averages at about 8,500 per year. At any given time there are 8 to 10 brain dead patients in different ICU's in any major city of the country. There is hence potentially a huge pool of brain death donors available in India.

The unrelated activity is due to loop holes in the present THO Act as under the Sub Clause (3), Clause 9 of Chapter II it states: "If any donor authorizes the removal of any of his human organs before his death under sub-section (1) of section 3 for transplantation into the body of such recipient, not being a near relative as is specified by the donor, by reason of affection or attachment towards the recipient or for any other special reasons, such human organ shall not be removed and transplanted without the prior approval of the Authorization Committee"

 It is not necessarily difficult to find an unrelated donor who suddenly develops an "affection or attachment" for the recipient provided he or she is properly rewarded. Most of the unrelated transplants are a result of the patients and clinicians using this section of the law to obtain permission from the Government to do live unrelated transplants. This aspect of the law has either to be scrapped or tightened so that only genuine cases are helped, otherwise unrelated activity will continue with the permission of government's authorization committee.

Mostly, private or non-governmental organizations have been working towards the success of the transplantation program. Among these the Initiative for Organ sharing group started by MOHAN Foundation in Tamil Nadu has shared 68 organs in the last 2 years between five hospitals. This is a encouraging start to the program. The foundation is also hoping to affiliate with other similar organization in other regions such as FORTE (Foundation for Organ Transplantation and Education) at Bangalore & ZTCC (Zonal Transplant Co-coordinating Committee) at Mumbai that have also similarly shared organs between different hospitals.

While this is true, we should be concerned that, in the 13 years since the law was passed, the Indian law has been observed more in the breach. As well documented by a series of investigations in Frontline magazine, the “affection” clause is the loophole that actually drives the entire transplant programme in the country. In state after state, authorisation committees have rejected a microscopic percentage of applications under this clause, turning a blind eye to what are obviously financial transactions. For example, the Karnataka authorisation committee approved 1,012 of the 1,017 applications it received from January 1996 to February 2002.

The industry has always had the support of those in power, and those in power have ways to get their dirty work done, as illustrated by the story of Kumar’s career. Senior Delhi police officials have confessed to picking up one of Kumar’s associates in January, but letting him free in exchange for Rs 20 lakh – handed over by Kumar himself. Further, Kumar has been running this business since 1994 at least. He was first arrested (as Santosh Raut) in 1994 along with a group of surgeons and anaesthetists for conducting kidney transplants at a nursing home in Mumbai. A government-appointed committee concluded that as many as 450 kidney transplants on foreign patients had been done in the nursing home from 1991 to 1994 though it had no license for conducting surgery. The committee noted that there were no medical records, evidence of consent or even evidence of basic medical infrastructure.

Kumar was arrested at least four times between 1994 and 2008 -- and obtained bail each time, following which he would disappear and resurface, running the same business in another part of the country.

Not one person is reported to have been prosecuted for violating THOA.

INDIA has a flourishing, and illegal, trade in human organs. And the legislation designed to prevent it is failing.

On Jan 24, police unearthed an illegal kidney transplant racket being operated from Haryana’s Gurgaon town, on the outskirts of the national capital. The people running the racket served clients from India and abroad after obtaining kidneys illegally, often under force, from poor people.

Every year, almost two lakh people in India need kidney transplants and there are only 4,000 people donating them, reveals Narendra Saini, media co-ordinator of the Indian Medical Association in Delhi. And this discrepancy in demand and supply leads to cases like the deeds of “Dr Horror” Amit Kumar, accused of running an illegal kidney racket out of Gurgaon. The incident has raised many questions, including the efficacy of the Transplantation of Human Organs Act, 1994.

Recently, a public interest litigation (PIL) was filed in the Delhi High Court, asking for exemption of dialysis kits from customs duty and making the process of kidney transplants easier and prevent illegal kidney transplants. He also demanded that the government initiate a programme for donation of organs on the lines of eye donation camps and review the 1994 Human Organ Transplantation Act. But he was asked to file a fresh petition due to some reasons.

On the eve of the World Kidney Day, the recommendations of the high court-appointed Transplant of Human Organs Act Review Committee that is awaiting implementation by the Health Ministry since three years became the topic of discussion in the Delhi High Court

Says Sanjay Ghosh, a Supreme Court lawyer, “Obtaining an organ illegally could be done in a life and death situation since ensuring that the patient lives is more important than abiding by the law.”

R.K. Sharma, secretary of the Indian Society of Nephrology in Lucknow, observes that “the government is considering second degree relatives for the donation of organs. While the current law is good, if it is made easy for people to donate organs there could be unrelated and professional donors creeping in and thus the new law would become a double-edged sword”.

“The object of the Act to prevent commercial dealing in kidneys has failed,” asserts Sardar Amjad Ali, a high court advocate in Calcutta. Ali mentions that for a non relative to donate a kidney, an authorisation committee has to approve the transplant but the supervision has been dismal, leading to a thriving kidney racket in the country.

Joymalya Bagchi, an advocate at the Calcutta High Court, indicates that a video of the consent of an individual could be made, in addition to the written statement, during donation to avoid further legal complications. “There is a lack of transparency in the current dealings that is leading to the law being broken,” he asserts.

The medical fraternity, however, says the law is too stringent for transplantation to be carried out legally all the time.

Says Narendra Saini of IMA, “The section mentioning that only close relatives can donate kidneys is too restrictive and needs to be widened. Also the provision for non relatives to donate kidneys for attachment or emotional reasons could be misused by any individual who could sell a kidney illegally.” Speaking of doctors like Amit Kumar, he says that he is not a registered medical practitioner There are quack doctors performing organ transplants in unregistered hospitals all over the country and this is the core problem with the law being bypassed.

The government is now mooting the idea of amending the Transplantation of Human Organs Act. Among the changes being considered are mandatory declaration that patients are brain dead by all intensive care units (ICU) of hospitals to help address the shortage of organs for donation in the country.

The Hon’ble High Court of Delhi in its order dated 6.9.2004 had set up a Committee to examine the provisions of Transplantation of Human Organs Act, 1994 and the Transplantation of Human Organs Rules, 1995. The report was submitted on 25.5.2005. A National Consultation was held on 18.5.2007 and the report was submitted in the second fortnight of August, 2007. The recommended changes required amendments in the Transplantation of Human Organs Act, 1994 and the Rules framed there under. These changes are intended to facilitate genuine cases, increase transparency in transplantation procedures and to provide deterrent penalties for violation of the law.

In so far as the Act is concerned, the following amendments have been proposed:
i) To empower Union Territories, specially Government of NCT of Delhi to have their own appropriate authority instead of DGHS and /or Additional DG (Hospitals).

ii) To make the punishments under the Act harsh and cognizable for the illegal transplantation activities to deter the offenders from committing this crime.

iii) To provide for registration of the centers for removal of organs from the cadavers and brain stem dead patients for harvesting of organs instead of registration of centers for transplantations only.

However, the Chief Justice of India K.G. Balakrishnan feels that there is no need to amend the Human Organ Transplantation Act, as the present law is “sufficient” to serve the cause, and they just need to be implemented properly. The comment came at a time when the health ministry was considering to bring a change in the law to curb illegal organ transplants. Experts have said that nearly 15 percent of adults in urban India are diabetic and 40 percent of them are likely to develop kidney problems, and every year over 150,000 new patients require dialysis or kidney transplant.

Therefore, in order to promote donation of organs, the government has planned to give incentives to the donor’s family like lifelong free medical check-up and care in the hospital where the organ donation took place. Besides, a customized life insurance policy of Rs 2 lakh for three years with one-time premium to be paid by the recipient in case of mortality and preferred status in organ transplant waiting list if the next-of-kin of a brain-dead donor requires a transplant in future.
To promote more brain death cadaver donation some changes are needed in Human Organ Transplantation Act such as intimation of Brain death to relatives, procedures in law to make it compulsory for the ICU staff to suggest for organ donation and request their permission for the same. In medico-legal cases-it should be made possible to under take 'post mortem' at the same time as the ' Organ retrieval' surgery. Shifting patient from one hospital for Organ donation to another for post mortem makes relatives very emotionally traumatized and delays the process of handing over the body.

It would be extremely fruitful if Grand parents are included in the near related category and if we accept the policy of presumed consent, i.e. every person dying of brain death should be presumed to have wished for organ donation until a written refusal is made by the family.

Most importantly, there is a need to spread awareness at every level. Surprisingly, Nurses and Medical students also do not know about the Act. That means that they need to be educated more about the Act, along with the rest of the population. It has been seen that the willingness to donate organs is directly proportional to the level of education, which needs to be increased.

No other field of medicine has raised so many ethical, moral, legal and social issues as has organ transplantation. At present the very term transplant is likely to conjure up an image of shady and dangerous dealings in India. If we wish to improve upon the current situation, the first step is total transparency on the part of the medical profession and open, public, debate on this and related issues. Medical professionals must set ethical guidelines and take action against violators. Representatives of the common people must be included on the committees that will