Cadaveric transplant programme

For a cadaveric transplant programme

http://www.hinduonnet.com/fline/fl1425/14250700.htm

ONE of the objectives of the Transplantation of Human Organs Act, 1994 was to clear the decks legally for the development of a cadaver-based organ transplantation programme. Towards this end, the Act recognised and defined, for the first time in India, the concept of "brain-stem death".

Since the Act came into force, however, only about 110 kidney transplants from cadavers have been performed in the country, according to Dr. J.V. Thachil, Chief Urologist at the Apollo Hospitals, Chennai, and Dr. J. Amalorpavanathan, Transplant Coordinator at the Government General Hospital, Chennai. Tamil Nadu is the clear leader in the field, with three leading medical institutions in the State accounting for 79 of these. Apollo Hospitals, Chennai, has done 53 cadaveric renal transplants; the Sri Ramachandra Medical College and Research Institute, Chennai, 14; and the Christian Medical College and Hospital, Vellore, 12. In addition, the Government General Hospital, Chennai, has done 8 cadaveric kidney transplants, and K.G. Hospital, Coimbatore, 2.

Leading nephrologists and urologists argue that the continuing commerce in kidneys acts as a disincentive to investments in cadaver-based programmes by capable medical institutions. There are, however, a few hospitals and organisations that are working with the objective of putting in place an effective cadaveric transplant programme and changing social attitudes towards organ donation.

Apollo Hospitals, Chennai, is way ahead of the rest. It performed the country's first renal transplant from a brain-dead person in October 1995. Since then the hospital has performed 52 more, making its programme the best cadaveric transplant programme in the country.

One lesson to be learnt from the Apollo experience is that a cadaveric transplant programme cannot take off unless the paid-donor programme is stopped and independent investments are made in setting up the infrastructure for a cadaveric programme. "What a hospital needs for a cadaveric transplant is a 24-hour laboratory that can do cross-matching as soon as we harvest a kidney from a cadaver," notes Dr. Thachil. "It must have a physical plan and an infrastructure for transplants; not just doctors, but theatres and nurses in a constant state of preparedness. We have done up to five transplants in a day."

A kidney can be harvested from brain-dead accident victims and also from victims of brain haemorrhage and cardiac arrest. Apollo has up to 35 persons on a waiting list for cadaver-based kidney transplants. Many of these patients, who are on dialysis, return to their cities and workplaces, and come when the hospital finds a kidney to match their specific needs. Apollo has given six kidneys that it harvested from brain-dead persons to other hospitals for transplantation as it could not find a match for persons on its waiting list.

On November 21, Dr. Thachil performed a renal transplant surgery on a 75-year-old patient from South Africa. Two kidneys harvested from a cadaver were transplanted into the recipient using what is called a "piggy-back technique". The patient had been on the waiting list for almost four months. Dr. Thachil says: "This man could easily have bought a kidney, but he chose to wait."

Once a brain-dead person's relatives have agreed to his or her organs being harvested, the transplant team has to move fast as delays affect the success rate; the best results are obtained when the kidney is harvested while the heart is still beating. The hospital bears the expenses of keeping the person on a life-support system; the organ retrieval costs are passed on to the recipient.

Asking for permission to harvest a brain-dead person's organs requires sensitivity to the family's grief. Dr. Thachil says that in 90 per cent of such cases, the relatives have given permission. "We brief the family fully and we tell them that the organ can be taken without any physical disfigurement of the body. Whenever I give a lecture, I tell people: when you die let you soul go to heaven, but leave your organs behind."

A donor card programme, under which a person may give consent for doctors to harvest his or her organs in the event of death, is at work in its initial stages in Chennai, Bangalore and some other cities. Such programmes are popular in other countries. Moreover, in several countries, the Law of Assumed Consent prevails: the state assumes that it has an accident victim's consent to harvest his or her organs in the event of death, unless he or she has left a statement expressly forbidding this (see interview with Dr. Christiaan Barnard, Frontline, November 14).

Dr. Thachil, however, believes that such a law may "backfire" in India. "In India you cannot overlook the family's wishes after a death has occurred. Apollo's experience has shown that you can have a cadaveric programme and can convince persons on a case-by-case basis."

AN organisation whose objective is to change social attitudes to organ donation is the Chennai-based Multiple Organ Harvesting Aid Network (MOHAN). MOHAN was launched in January 1997 by Dr. Sunil Shroff, a transplant surgeon who heads the Department of Urology and Renal Transplantation at the Sri Ramachandra Medical College and Research Institute, Chennai. It has begun a donor card scheme to raise awareness about the need to donate 'solid' organs (kidney, heart, liver, lungs and pancreas). A person who enrols in the scheme signs a card and thus consents to his organs being harvested after his death. MOHAN has distributed 17,000 donor cards so far.

The SRMC&RI has performed 57 kidney transplants (including 14 cadaveric kidney transplants) since 1995. A team of doctors from the Department of Urology and Renal Transplantation at SRMC&RI conducted a sample survey in Chennai to test social attitudes towards organ donation. The sample was stratified to capture different socio-economic classes and religious groups in Chennai's population. Individual questionnaires were given to 8,000 persons, of whom 5,008 responded. Their responses indicated that awareness about organ transplants was high; more than half the people who responded expressed "some degree of familiarity" with the concept of brain-death. More than 70 per cent were willing to carry a donor card. The most significant finding was that the proportion of people who were willing to donate their eyes was substantially higher than the proportion of people who were willing to donate solid organs after death.

The survey's results point to the significant success of the campaign for eye donations. Such a campaign could serve as an example for a similar effort to raise awareness about the need for donating other organs.

NO cadaveric renal transplant has yet been performed in Karnataka. However, the Foundation for Organ Retrieval and Transplant Education, a non-profit trust founded in September 1996, is helping put in place a programme under which people can signify their willingness to allow doctors to harvest their kidneys, liver, pancreas, heart, heart valves and eyes after their death. The programme was begun by Dr. Philip G. Thomas, a transplant surgeon at St. John's Hospital, Bangalore, and his wife Rebecca Thomas, a trained transplant coordinator who worked at the Centre for Organ Recovery and Education (CORE), Pittsburgh.

FORTE works with the 10 Bangalore hospitals that are authorised by the Karnataka Government to perform cadaveric transplants, and coordinates the donation and transplantation of organs. It has distributed 1,000 donor cards and received consent from 200 persons for the harvest of their organs after death. Nine patients with End-Stage Renal Disease and one heart patient are currently registered with FORTE seeking organ donors.

Multi Organ Transplant

Multi Organ Transplant

Overview

The Multi Organ Transplant is becoming famous day by day. The donation of the organs has made the procedure easier. The common problem of the organ transplantation is rare availability of the donators. The most important part is to make people more aware of the fact that it is like giving a person a new life.

Multi organ transplant involves bone marrow, heart, kidney, kidney-pancreas, liver, and multi-visceral transplantation. All the surgeries are regarded as the complicated surgeries and Apollo plays role of an efficient in performing these vital operations. All the surgeries are done by our experienced expert surgeon who not only help you with the procedure but will take a special care.

Apollo facilities

Apollo has a well-equipped Multi Organ Transplant department. Various surgeries have their respective requirements and characteristics; most importantly each human problem differs from the other so you should consult your surgeon before entering your respective procedure of surgery.


Apollo offers the excellent centre for the surgery and provides its best service, hospitality and expert doctors for the Multi Organ Transplant, creating a pleasing appearance for the person.
Procedures and Prices

Specialities/ Procedures
Price
Duration of Stay

(US $)
(UK £)

Transplant

Kidney Transplant

a) Open (Recipient & Donor)
14500
8400
10 Days

b) Laproscopic (Recipient & Donor)
14500
8400
10 Days


Liver Transplant
To be quoted on case basis



Medical India tourism offers online bookings .To book your medical packages and for more information present your queries in the form below.

Cadaver Organ Donation and Transplantation in India

Dr.Sunil Shroff, Dr.Sumana Sundaram, Dr.Georgi Abraham, Dr.Sounddarajan, Dr.Suresh, Dr.Subba Rao, Dr.Paulose Thomas


Introduction

Patients& Method

Results

Discussion

References

Introduction

Since the passing of the legislation in India, entitled, 'Transplantation of Human Organ (THO) Act' in 1994, it has been possible to undertake multi-organ transplant activity from brain dead donors. The required pre-requisite for success of the cadaver program depend on various factors1-3 and these include:

1. Positive attitude of public towards organ donation
2. Consent by relatives for organ donation in event of brain
death.
3. Successful brain Death identification and certification.
4. Adequate hospital infra-structural and support logistics
5. Successful retrieval and transplantation of organs and
auditing long term graft outcomes.

This review looks at these aspects in the Indian context and discusses the difficulties encountered in implementing this program over the last 6 years.


Patients & Method

1. After passing of the THO legislation a major survey of the 5008 members of Indian public's attitude towards organ donation was conducted in 1995-96 by the principal author and a brief analysis of this survey's result are presented 4.

2. In one major hospital in Chennai, undertaking cadaver transplants regularly; an audit of 159 'Brain death' patients over the last 5 years was undertaken. This was to look at the number of these patients who actually became organ donors.

3. Data of all the transplants centers in India undertaking cadaver transplants since the passing of the legislation was collated for this study.

4. Infra-structural Support services available at the hospitals undertaking the cadaver program was looked at and a critical analysis was made of the deficiencies.

5. The results of first 100-kidney cadaver transplant from 4 major hospitals in the country were analyzed to look at 1 and 2 year kidney allograft and patient survival.


Results

1. "Public attitude Survey to organ donation": This survey showed 72% of the population were willing to donate eyes and carry a 'Donor Card', however 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 4.

2. Organ donation in Brain death situation: An audit of 159 brain death patients showed that 30 or 19% of the relatives donated of the organs of their loved ones.

3. The Total Cadaver Transplants activities: For various solid organs5 are as follows from Jan 1995 to Jun 2001:

Kidney 379
Heart 34
Liver 12
Pancreas 02
Lungs 01
TOTAL 428

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 (189). Besides Chennai the other cites where the cadaver organ transplantation is taking place include New Delhi (68), Ahmedabad (46), Pune(32), Bangalore (32), Vellore (22), Mumbai (20) and Coimbatore (12).

4. Hospital Infra-structural and Support Logistics: All 35 hospitals were supported by intensivists and adequate Intensive care facilities and fully qualified and trained

medical and para-medical staff to undertake the cadaver transplant program.

However most of them lacked motivated medical or social workers who could be trained to speak to the relatives in brain death situations. There were only 15 transplant co-coordinators of whom very few had any proper or formal training in the field. There were about 12 organizations in the country working to promote and help out with the cause of organ donation however only 3 were actively involved and worked as a central co-coordinating agency for allocation and distribution of organs.

5. Results of the first 100 transplants from 4 major centers: The mean age of the patients was 45 years with a range from 3 years to 72 years. There were 62 males and 38 females transplanted. The one-year allograft and patient survival was 82% and 86% respectively and the 2-year allograft and patient survival was 74% and 80%.


Discussion:

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. 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.

When the THO act was passed there were very few evangelist and many more detractors of this legislation. The evangelist in the country felt it would stop commercial dealing in organs, open up multi-organ transplant activity and increase the number of transplants in India. The detractors felt that this legislation was unlikely to succeed in the Indian context in view of the religious and cultural diversity, poor socio-economic background and lack of infra structural support available for implementing the cadaver transplant program.

The public attitude survey indicated a positive attitude of the people towards eye donation. After this survey a simple protocol was devised (Ramachandra required request protocol when asking for organ from relatives). It was suggested that' Eyes' should be requested for first and only if the relatives were willing other organs requested. This it was felt was less likely to upset the relatives in a brain death situation, and would also give the hospital staff asking for organs an idea about the family's attitude towards the sensitive issue like organ donation in the difficult brain death situation4. 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 India6.

Most of the hospitals undertaking cadaver transplants are either private or trust

hospitals and there are very few government hospitals undertaking this program.
Out
of 27 states in India four states are still to enact the 'Transplant legislation' and accept brain death concepts. Hence to make the cadaver program a success a re-think of how to implement this program is necessary. One of the major hurdles seems to be the unrelated transplant activity that continues unabated. Kidney scandals still continue to haunt the country every so often. 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.

Up to 1997 only four hospitals in the country were undertaking cadaver transplants. However, now more and more hospitals encouraged by the success of others are now indulging themselves in this program. On an average over 55 cadaver transplants are being undertaken in India every year. This is unlikely to meet the present demand for organs. It is estimated that every year there are 3500 kidney transplants are being undertaken.

As the cadaver program is still in infancy stage the early results of kidney cadaver transplants are acceptable. Two hospitals (All India Me Institutes of Medical Science, Delhi and Madras Medical Mission, Chennai) are undertaking heart transplants. Only one hospital, Indraprastha Apollo Hospital Delhi is undertaking liver transplants regularly.Over the last 2 years local state based networks are being established by a few non- governmental and non-profit motivated organizations in the country. Among these the Initiative for Organ sharing group started by MOHAN (Multi Organ Harvesting Aid Network) 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.


There is potentially a huge pool of brain-death patients in the country who could not only meet the local demands of organs but may be able to meet the needs of some of the neighboring countries which sometimes looks towards India for their healthcare needs. Despite the many problem in implementation of this program in India a start has been made and the first hurdle has been crossed. Education of public on concepts of brain death and having more trained transplant coordinators, allocation of resources from government and private agencies for the program and having a state based network with a central network office would help to give this program the required boost in the country.


REFERENCES
1. Evans RW, Manninen DL: Transplant Proc 20: 781, 1988
2. Feest TG, Reid HN, Collins CH, et al: Lancet, 335:1133, 1990
3. Wakeford RE, Stepney R: British Journal of Surgery,
76:435, 1989
4. Shroff S, The Antiseptic, 94:73-74, 1997
5. Cadaver Transplant Activity - All India Figures - 1999 to
June 2001 Indian Transplant Newsletter 3:9, 4,2001
6. INOS and the essence of organ sharing- Editorial, Indian
Transplant Newsletter, 3-10, 2001

Institutions:

Sri Ramachandra Medical College & Research Institute, Chennai
Apollo Hospital, Chennai,
Christian Medical College, Vellore,
Sundaram Medical Foundation, Chennai
MOHAN (Multi Organ Harvesting Aid Network) Foundation, Chennai




http://www.medindia.net/articles/article5.asp

Donating lives with Heart transplantation

http://www.hinduonnet.com/fline/fl1522/15220920.htm

Donating lives

Heart transplantation can hold out hope for a large number of patients in India but a smooth donor mechanism will need to be put in place and the costs involved will have to become affordable to more people before the numbers of such procedures can reach levels comparable to developed countries.

RASHEEDA BHAGAT

IN a special room in Apollo Hospitals in Chennai, 36-year-old A.S. Subramaniam, who received the gift of a 'new' heart a couple of weeks earlier, spoke about the operation that gave him a new lease of life. According to him, the operation went through like a dream, the bill amounting to around Rs. 3 lakhs has been taken care of, and he is accorded "royal" treatment.

Yet, even as he speaks about his good fortune, a dark shadow clouds his face. While on the one hand he is happy that his four-year-old heart problem has been solved, Subramaniam, an executive engineer with Neyveli Lignite Corporation (NLC), is worried as to how he will raise the enormous amount of money required to maintain the foreign organ in his body.

After he suffered a heart attack in June 1994, Subramaniam required regular medical help. He told Frontline: "I was told by my cardiologist that the only remedy for my terminal heart problem was a transplant." With a take-home salary of barely Rs. 7,000, Subramaniam, who has a wife and two children aged 11 and six years to support, had no hope of raising the Rs. 3 lakhs required for a transplant. However, when a donor organ became available and the Apollo Hospitals' cardiac surgery team volunteered to perform the surgical procedure free of cost and take care of the material as well as hospitalisation costs, it was like a dream come true.

However, Subramaniam now has to raise Rs. 2 lakhs, which is required over the next 12 months for various medical tests and for immuno suppressants required to prevent rejection of the organ. The monthly expenses on immuno suppressants, such as cyclosporin, range between Rs. 4,000 and Rs. 10,000. (The dosage will come down progressively.) Subramaniam has no assets other than is ancestral house in a small town in Tamil Nadu. "Even if this house is sold," he said, "my sister has to be given her share." He has no idea about how much NLC will contribute towards his medical treatment.


BY SPECIAL ARRANGEMENT
A heart transplant procedure in progress at Apollo Hospitals in Chennai.

GAJANAND GUPTA, 39, was the first patient on whom a heart transplant procedure was performed at Apollo Hospitals in Chennai. After living with a diseased heart for 10 years, during which period he had to close down his business, he received a 'new' heart on December 24, 1995. "When I was in the hospital, I was told that my lifespan could be as short as four days or as long as 40 days. So, when the heart of a 28-year-old accident victim became available, I told myself: 'I may die after four days. If the operation is not successful, I will die today. What difference will these four days make to my life?' So I agreed to the surgery."

Three years later, Gupta, who works as a ticketing agent for a domestic airline, is fit enough to meet the rigours of his job which requires him to do a lot of running around. "This is the best treatment in the world for myocardial patients," he said, "provided you can afford it."


BIJOY GHOSH
A.S. Subramaniam, who recently underwent a heart transplant surgery at Apollo Hospitals.

Although the Apollo Hospitals' cardiac surgery team has been very supportive and he is certain that the doctors themselves pay for the investigations, Gupta still needs to raise the money for cyclosporin month after month. "Until now I have managed to get by on help from the doctors, my friends and relatives. But frankly, if I had known that it was going to require so much of money to keep breathing, I wouldn't have gone in for the surgery. Unless you have the money, you end up being a beggar," he said ruefully.

In a developing country such as India, the operative words are "afford it". Although the most positive aspect of a heart transplant procedure is that it bestows a new lease of life on its beneficiaries, the prohibitive costs involved may prove to be a deterrent to many. Ironically though, most of the patients who have undergone a heart transplant are those who could not afford it and have had to depend on charity to pay for their immuno suppressants.

There are also people such as R.S. Sudarshan, a businessman who underwent a heart transplant at the Madras Medical Mission, who are able to bear the entire cost of the treatment. But people like him are few and far between.

THE high cost of surgery, medical investigations and the prolonged post-surgical medication is not the only factor that has kept the number of heart transplant procedures in India at an abysmal low. Donor hearts are also hard to come by.

Dr. M.R. Girinath, chief of the cardio vascular department at Apollo Hospitals, pointed out that even though the surgical aspect of a heart transplant is simple, the lack of awareness and the dearth of organ donors have led to a situation where the number of heart transplants performed in India is very low. Over the past four years only 25 heart transplants have been performed in the country. Dr. Girinath said: "The few attempts that have been made to increase public awareness about organ donation have not really paid dividends. Only when a family that is about to lose its loved one is approached by doctors to donate his or her organs does the message of organ donation crystallise. Until then it is only an empty thought." He said that the most distressing aspect of waiting for donor organs is that a number of patients die before donors can be found.


T.A. HAFEEZ
Dr. K.M. Cherian of the Madras Medical Mission in Chennai.

Dr. K.M. Cherian, director of the Institute of Cardio Vascular Diseases run by the Madras Medical Mission in Chennai, where six heart transplants were performed over the last four years, is unhappy that even among the medical community, there is a near-total lack of commitment to the cause of transplant surgery. He said: "It seems that 40 cadaveric kidney procedures were done last year. Surely all those 20 people had hearts. I would like to know what happened to those 20 hearts? The MGR Medical University in Chennai established a Central Organs Registry last year. How many institutions that had cadaver kidneys contact this Central Registry to say 'We have a donor with such a such blood group?' If they didn't contact the Registry, we should ask why."

According to Dr. Cherian, the reason for this apathy is "jealousy and counter-productive competition" in the medical fraternity. He said that the All India Institute of Medical Sciences (AIIMS) had stopped performing heart transplants, and added that it was probably because of lack of coordination among the neurology, accident and cardiac departments. "We are not a centre where accident or neuro cases come," he said. "We have to depend on other hospitals to get donors. We have been certified by the Tamil Nadu Government for performing heart, lung and kidney transplants and when we get a donor we are willing to extend our facilities to anybody who wants to perform a kidney transplant." (A kidney transplant procedure was performed at his institute by a team from the Sri Ramachandra Medical College Hospital in Chennai.)

According to Dr. Cherian, the majority of the 79,000-odd people who die in road accidents in India every year are potential organ donors. Apart from the reluctance of the dying person's relatives to donate the organs (organs such as kidneys, liver and heart have to be removed when the heart is still beating), another stumbling block is the requirement to constitute a panel of neurologists which has to certify that a patient is brain dead before his or her organs are removed. Dr. Cherian questions the logic behind appointing government doctors as members of these panels.

Of the six cases in which heart transplant procedures have been performed at the MMM, five patients are alive and doing well. September 23 marked the third anniversary of the first heart transplant procedure performed at the MMM. The recipient was Maimoona Beevi, a bangle seller. MMM observes this day as Organ Donation Awareness Day.



Dr. M.R. Girinath of Apollo Hospitals.

While Maimoona Beevi was the first woman on whom a heart transplant procedure was performed in India, the MMM has another first to its credit. The country's first paediatric heart transplant was performed at the MMM about 18 months ago on an 11-year-old boy who suffered from cardio myopathy. The Pallavan Transport Corporation paid a part of the costs since the boy's father was its employee. The remaining costs were borne by the MMM.

SINCE donor hearts are difficult to get, doctors have to be careful about the choice of recipients. Dr. Girinath said that he would choose patients "who have a life expectancy of less than six months without the operation." "This means that they are in an advanced stage of heart failure and there is nothing else you can do for them." In addition, the patients should not have very high pressure in the lungs and the arteries of the lungs and their other vital organs should be functioning well.

Dr. Cherian's team does not use steroids. Dr. Cherian said: "Compared to others who perform heart transplants in India, we use a smaller quantity of immuno suppressants and have stopped using steroids, which is a conventional method of treatment." According to him, non-use of steroids is the latest development in heart transplantation techniques. Dr. Cherian said that the 10-year survival rate for heart transplant patients is around 45 to 50 per cent.

Dr. P.V. Rao, a cardiac surgeon at Apollo Hospitals, who performed the transplant procedure on Subramaniam, said that despite the fact that the number of heart transplant procedures performed in India was only a fraction of those performed in the United States and Europe (each of which witnesses about 2,000 procedures a year), the future looked optimistic. "Heart surgery started in a very small way in India," he said, "but today over 50,000 open-heart operations and one lakh closed-heart operations are being done. Tomorrow, if the costs come down or some technological advance takes place, we can make rapid strides in this area."

However, until such a scenario emerges, most of the patients who need to undergo this procedure to survive will not be able to afford it. Dr. Girinath said: "We can waive the surgical and hospitalisation costs, but the biggest problem is to keep the patients going on the immuno suppressants after the surgery."

Organ Retrieval and Banking Organisation

What is organ donation? It means that a person pledges during his lifetime that after death, organs from his/her body can be used for transplantation to help terminally ill patients and giving them a new lease of life. There are two ways of Organ donation: Living related donors:- only immediate blood relations (brother, sister, parents & children) can donate as per the Transplantation of Human Organ Act 1994. Living donor can donate only few organs, one kidney (as one kidney is capable of maintaining the body functions), a portion of pancreas (as half of the pancreas is adequate for sustaining pancreatic functions) and part of the liver (as the few segments that are donated will regenerate after a period of time) can be donated. Cadaver Organ donor:- can donate all organs after brain death.

What organs and Tissues can be donated? The major donor organs and tissues are heart, lungs, liver, pancreas, kidneys, eyes, heart valves, skin, bones, bone marrow, connective tissues, middle ear, blood vessels. Therefore one donor can possibly give gift of life to many terminally ill patients who would not survive otherwise.

What is brain death? It is the irreversible and permanent cessation of all brain functions. Brain can no longer send messages to the body to perform vital functions like breathing, sensation, obeying commands etc. Such persons are kept on artificial support (ventilation) to maintain oxygenation of organs so that the organs are in healthy condition until they are removed. Most cases of brain death are the end result of head injuries, brain tumours patients from Intensive care units. Organs of such patients can be transplanted in organ failure patients to provide them a new lease of life.

How is brain death diagnosed? It is done by independent advice of a team of doctors whose qualification and experience is accepted by the hospital for such purposes. Doctors carry out a set of tests to confirm brain death. The two sets of tests are carried out at the interval of at least 6-12 hrs. Legal time of death is the time at which the second set of test is carried out. Once declared brain dead, further artificial support is futile and actually is emotional and financial trauma. At this time a decision for organ donation should be taken at the earliest.

How quickly should the organs be donated? Healthy organs should be transplanted as soon as possible after brain death from the donor to the recipient.

Who can be a Donor? Anyone, regardless of age, race or gender can become an organ and tissue donor. If he/she is under the age of 18 years, then the consent of parent or legal guardian is essential. Medical suitability for donation is determined at the time of death.

Who can give consent for organ donation after brain death? Donors who have during their lifetime consented for organ donation in writing in the presence of two witnesses (at least one of whom is a near relative,) should carry their donor cards with them and also express their wishes to their near and dear ones. In case of no such consent or donor pledge form was filled before death, then the authority to give consent for organ donation lies with the person lawfully in possession of the dead body.

Which terminal diseases can be cured by transplant? Here are some terminal diseases which can be cured by the transplantation:- Heart heart failure Lungs terminal lung illnesses Kidneys kidney failure Liver liver failure Pancreas diabetes Eyes blindness Heart valve valvular disease Skin severe burns

Who will receive your organ? Your vital organs will be transplanted into those individuals who need them most urgently. Gifts of life (Organs) are matched to recipients on the basis of medical suitability, urgency of transplant, duration on the waiting list and geographical location.

Is there any charge to my family for organ donation? No, there is no charge nor payment for organ/tissues used in transplantations. Organ donation is a true gift.

Does organ / tissue removal affect cremation / burial arrangements or disfigure the body? No. The removal or organs or tissues will not interfere with customary funeral or burial arrangements. The appearance of the body is not altered. A highly skilled surgical transplant team removes the organs and tissues which can be transplanted in other patients. Surgeons stitch up the body carefully, hence no disfigurement occurs. The body can be viewed as in any case of death and funeral arrangements need not be delayed.

Will the doctor ask permission of donation from my family, once the signed donor card is found? Yes. Doctor will always ask the permission of organ donation from the family if your signed card is sighted. Therefore, it is important that you discuss your decision with family members and loved ones so that it will be easier for them to follow through with your wishes.

What is legal position on organs donations? It is legal by law. The government of India has enacted the "transplantation of human organs act 1994" in Feb. 1995, which has allowed organ donation and legalised brain death.

Is it permissible to sell human organs? No, "The Transplantation of Human Organs Act 1994" prohibits the sale of human organs and tissues. Violators are subject to fines and imprisonment.

Can organs be removed after death at home? No. It can only be removed when a person is brain dead in the hospital and is immediately put on a ventilator and other life support systems. After death at home, only eyes and tissues can be removed.

Indian Cadaveric Organ Donation Programme

http://www.indiaprwire.com/pressrelease/health-care/20060802473.htm

Indian Cadaveric Organ Donation Programme

A Distant Dream or an Achievable Goal?

Human-to-human transplantation of organs has been accepted by doctors worldwide as the best line of treatment and often the only one for a wide range of fatal diseases such as End Stage Renal Disease (kidney failure). Organ transplantation has been one of the greatest advances of modern science that has resulted in many patients getting a renewed lease of life. It would not be possible without organ donation. Organs can be donated by a living person, after natural death or after "brain death". After natural death only a few tissues can be donated (like cornea, bone, skin and blood vessels) whereas after brain death almost 37 different organs and tissues can be donated including critical organs such as kidneys, heart, liver and lungs.

In the United States, in 2004, there were over 14,000 organ donors - an increase of 695 donors (7%) over 2003. During this time the number of cadaver donors grew by 11% to 7,152, the largest annual increase in deceased donors in the last 10 years. In 2005, the number of kidneys transplanted from cadavers was 9,914, while the number of patients who received transplants from living donors was 6,563.

Dr AK Bhalla, Seceratary, Delhi Nephrology Society, & a Senior Consultant Nephrologist with Sir Ganga Ram Hospital, New Delhi, opines, "As shown by the US statistics human organ donation is fast developing into a major treatment protocol. However it is yet to make any significant dent in India. A country with a population of over 1 billion people, India lags behind in the implementation of a cadaveric donation programme". Annually, while over 100,000 Indians suffer from End Stage Renal Disease, only a mere 3,000 are recipients of a donor kidney, of which only a small percentage are cadaver organs. In fact, the total number of patients who have received cadaver kidneys in India from 1995 to 2003 is only 524 , an abysmally small figure. The major problem now facing transplant surgery is a critical shortage of available organs.

An Act was passed by the Government in 1994 to streamline various organ donations and transplant activities in the country. For years, India had the reputation of being a "warehouse for kidneys" and an "organ bazaar" as poverty forced people to sell their kidneys commercially. With a view to prohibiting the sale of organs in India, the Government introduced, in 1994, The Human Organ Transplantation Act. The Act had the following aims in mind - to curtail the kidney racket by introducing a rule that states that only a first-relative can be a living donor, to legalise the definition of "brain death", and to encourage cadaveric organ transplants.

According to Dr Vijayakumar, Chief Nephrologist at the Kaliappa Hospital, Chennai, "The Human Organ Transplantation Act has legalised the concept of 'Brain Death' for the first time in India. Since the passing of the legislation in India, it has become possible to undertake organ transplants from brain dead donors. Improved infrastructure such as ventilators and other emergency measures are necessary to improve the lives of the accident victims. Also, routine 'Brain Death' certification in neurosurgical wards could significantly increase the number of cadaver donors. Furthermore, relatives need to be educated about the futility of keeping brain dead accident victims 'alive'. A good motivator is needed to encourage people to donate organs."

Until 1997, only four hospitals in India were undertaking cadaver transplants. However, now more and more hospitals are taking up the programme. The successful implementation of this programme however hinges on the education of the masses and having more trained transplant co-ordinators. According to a "Public Attitude Survey to Organ Donation", less that 50 per cent of the population was willing to consider solid organ donation, and the concept of "brain death" was new to most people surveyed.

12 years after the Human Organ Transplantation Act has been passed, the cadaver programme in India is still in its infancy stage and there is potentially a huge pool of brain-dead patients who could meet the demands of the country for various organs.

Dr Vishwanath Billa, Hon. Nephrologist & Kidney Transplant Physician, Bombay Hospital & Medical Research Centre, Mumbai, states, "A proactive attitude towards cadaveric organ donation, counselling for relatives for organ donation in the event of brain-death, adequate hospital infrastructure, matching and distribution of the organs and co-ordination amongst hospitals will ensure that we convert the current programme to the level of Western Countries."

- End -

Human-to-human transplantation of organs has been accepted by doctors worldwide as the best line of treatment and often the only one for a wide range of fatal diseases such as End Stage Renal Disease (kidney failure). Organ transplantation has been one of the greatest advances of modern science that has resulted in many patients getting a renewed lease of life. It would not be possible without organ donation

Transplant of Human Organs - Forms

As Published In The Gazette of India Extraordinary Part-II Section 3- Sub Section (i) Published by authority Issue No. 39- New Delhi Saturday, February 4, 1995 Magha 15, 1916
THE GAZETTE OF INDIA: EXTRAORDINARY (PART II Sec. 3-Sub-sec (ii)) MINISTRY OF HEALTH AND FAMILY WELFARE NOTIFICATION Published by Authority No.71, New Delhi Saturday February 4, 1995 / Magha 15, 1916
S.O.80(E) - In exercise of the powers conferred by sub-section (3) of section 1 of the Transplantation of Human Organs Act, 1994 (42 of 1994), the Central Government hereby appoints the Fourth day of February, 1995, as the date on which the said Act shall come into force in the States of Goa, Himachal Pradesh and Maharashtra and all the Union Territories.
(No. S, 12011/2/94-MS)	O.P. NIGAM, Chief Controller of Accounts

MINISTRY OF HEALTH & FAMILY WELFARE NOTIFICATION
New Delhi, the 4^th February 1993

G.S.R. 51 (E) - In exercise of the powers conferred by sub-section (1) of Section 24 of the Transplantation of Human Organs Act. 1994(42 of 1994), the Central Government hereby makes the following rules, namely -

1. SHORT TITLE AND COMMENCEMENT

(1) These rules may be at the earliest be the transplantation of Human Organs Rules, 1995.
(2) They shall come into force on the date of their publication in the Official Gazette

2. DEFINITIONS

(a) Act” means the Transplantation of Human Organs Act, 1994 (42 of 1994);
(b) “Form” means a form annexed to these Rules;
(c) “Section” means a section of the Act;
(d) Words and expressions used and not defined in these Rules, but defined in the Act, shall have the same meanings respectively assigned to them in the Act.

3. AUTHORITY FOR REMOVAL OF HUMAN ORGAN

Any donor may authorise the removal, before the death, of any human organ of his body for therapeutic purposes in the manner and as such conditions as specified in Form 1.

4. DUTIES OF THE MEDICAL PRACTITIONER

(1) A registered medical practitioner shall, before removing a human organ, from the body of a donor before his death satisfy himself -

(a) that the donor has given his authorization in the Form 1

(b) that the donor is in proper state of health and is fit to donate the organ, and shall sign a certificate a specified in Form 2.

(c) that the donor is a near relative of the recipient and shall sign a certificate as specified in Form 3 after carrying out the following tests on the donor and the recipient, namely:-

(i) tests for the antigenic products of the Human Major Histo-compatibility system HLA-A, HLA-B and HLA-DR using conventional serological techniques;
(ii) tests to establish HLA-DR beta and HLA-DQ beta gene restriction fragment length polymorphism;
(iii) Where the tests referred to in sub-clause(i) and sub-clause(ii) do not establish a genetic relationship between the donor and the recipient further tests to establish DNA polymorphism using at least two multi locus gene probe;
(iv) Where the tests referred to in sub-clause (iii) do not establish a genetic relationship between the donor and the recepient further tests do establish DNA polymorphisms using atleast 5 single locus polymorphic probes.

(d) in case recipient is a spouse of the donor, record the statements of the recipient and the donor to the effect that they are so related and shall sign a certificate in Form 4;

(2) A registration medical practitioner shall, before removing a human organ from the body of a person after his death satisfy himself -

(a) that the donor had in the presence of two or more witnesses (at last one of whom is a near relative of such person) unequivocally authorized as specified in Form 5 before his death, the removal of the human organ of his body, after his death, for therapeutic purposes and there is no reason to believe that the donor had subsequently revoked the authority aforesaid
(b) that the person lawfully in possession of the dead body has signed a certificate as specified in Form 6 or Form 7.

(3) A registered medical practitioner shall before removing human organ from the body of a person in the event of his brainstem death satisfy himself -

(a) that a certificate as specified in Form 8 has been signed by all the members of the Board of medical experts referred to in sub section (6) of section 3 of the Act
(b) that in the case of brain stem death of a person of in less than eighteen years of age, a certificate specified in Form 8 has been singed by all the members of the Board of medical experts referred to in sub-section (6) of Section 3 of the Act and an authority as specified in Form 9 has been signed by either the parent of such person.

5. PRESERVATION OF ORGANS

The organ removed shall be preserved according to current and accepted scientific methods in order to ensure viability for the purpose of transplantation.

6. The donor and the recipient shall make jointly an application to grant approval for removal and transplantation of a human organ, to the Authorization Committee as specified in Form 10

7. REGISTRATION OF HOSPITAL

(1) An application for registration shall be made to the Appropriate Authority as specified in Form 11. The application shall be accompanied by a fee of rupees one thousand payable to the Appropriate Authority by means of a bank draft or postal order.
(2) The Appropriate Authority shall after holding an inquiry and after satisfying itself that the applicant has complied with all the requirements, grant a certificate of registration as specified in Form 12 and shall be valid for period of 5 years from the date of its issue and shall be renewable.

8. RENEWAL OF REGISTRATION

(1) An application for the renewal of a certificate or registration shall be made to the Appropriate Authority within a period of three months prior to the date of expiry of the original certificate of registration and shall be accompanied by a fee of rupees five hundred payable to the Appropriate Authority by means of a bank draft or postal order.
(2) A renewal certificate of registration shall be as specified in Form 13 and shall be valid for a period of five years
(3) If, after an inquiry including inspection of the hospital and security of its past performance and after giving an opportunity to the applicant, the Appropriate Authority is satisfied that the applicant, since grant of certificate of registration the under sub-rule (2) of Rule 7 has not complied with the requirements of this Act and the rules made there under and conditions subject to which the certificate of registration has been granted, shall, for reasons to be recorded in writing, refuse to grant renewal of the certificate of registration.

(9) CONDITIONS FOR GRANT OF CERTIFICATE OF REGISTRATION

No hospital shall be granted a certificate of registration under this Act unless it fulfills the following requirement of manpower, equipment, specialised services and facilities as laid down below -

GENERAL REQUIREMENT

1. Surgical Staff
2. Cardiology Staff
3. Nursing Staff
4. Communication System
5. Intensivist
6. Medical Social Worker
7. Perfusionist

VARIOUS DEPARTMENT

1. Microbiology
2. Mycology
3. Pathology
4. Virology
5. Nephrology
6. Neurology
7. Psychology
8. G.I. Surgery
9. Anaesthesiology
10. Imaging Facilities
11. Paediatrics
12. Physiotherapy
13. Immunology
14. Haematology
15. Blood Bank
16. Clinical Chemistry
17. Cardiology

NON-TRANSPLANTATION PROGRAMME TEAM

1. Neurologist
2. Neurosurgeon
3. Medical Superintendent
4. Any other hospital Staff

BASIC EQUIPMENT

Operating Room facilities for routine open heart surgery which includes heart-lung machine and accessories.

ADDITIONAL EQUIPMENT REQUIRED FOR TRANPLANTATION PROGRAMME

1. Cell Saver
2. Assist devices like IABP, Centrifugal Pump and various assist devices, both pneumatic and electric operated.
3. Mobile C-arm image intensifier for routine biopsies in the street operating room
4. Euct /Alert system for early detection of any infection
5. Radioimmunoassay for measuring Cyclosporin levels.
6. Routine Laboratory facilities for detection of HIV, Australia antigen, CMV, Toxoplasnosis and other Mycology Tests

EXPERTS
(A) Kidney Transplantation

M.S. (Gen.) Surgery or equivalent qualification which three years post M.S. training a recognized center in India or abroad and having attended to adequate number of renal transplantation as an active member of team

(B) Transplantation of Liver & Other Abdominal Organs

M.S. (Gen.) Surgery or equivalent qualification with adequate post M.S. training in an established center with reasonable experience of performing liver transplantation as an active member of team

(a) Cardiac, Pulmonary Cardio-Pulmonary Transplantation.
M.Ch Cardio-thoracic and vascular surgery or equivalent qualification in India or abroad with at least 3 years experience as an active member of the team performing an adequate number of open heart operations per year and well-versed with coronary by-pass surgery and Heart valve Surgery.

10. APPEAL

(1) Any person aggrieved by an order of the Authorisation Committee under sub-section (6) of section 9, or by an order of the Appropriate Authority under sub-section (2) of section 15 and Section 16 of the Act, may, within thirty days from the date of receipt of the order, prefer an appeal to the Central Government

(2) Every appeal shall be in writing and shall be accompanied by a copy of the order appealed against

Amendment of the Human Organ Transplant Act

On 6 January 2004, the Human Organ Transplant Act (HOTA) was amended to allow more Singaporeans to benefit from organ donation. The main amendments to HOTA were (a) to extend HOTA beyond kidneys to include livers, hearts and corneas; (b) to extend HOTA beyond deaths due to accidents to include all causes of deaths; and (c) to extend HOTA beyond cadaveric organdonation to also regulate living donor organ transplants. In this article, we review the amendments to HOTA and the Interpretation (Determination and Certification of Death) Regulationsand examine the impact of HOTA on organ procurement and transplantation in Singapore.Ann Acad Med Singapore 2006;35:428-3



Kidney transplants have been carried out in Singapore
for more than 35 years, with the first cadaveric kidney
transplant operation performed on 8 July 1970.
1
However,
prior to the commencement of the Human Organ Transplant
Act (HOTA) in 1988, there was only a small number of
kidney transplants; between 1970 and 1987, only 85
cadaveric kidney transplants were carried out using kidneys
procured from local donors in Singapore.
2
There are 2 laws pertaining to organ donation in Singapore
– the Medical (Therapy, Education and Research) Act
(MTERA) and HOTA. A third set of legislation, the
Interpretation Act, provides the criteria for determining
death. It allows for death to be defined in terms of cardiac
death or brain death. The Interpretation (Determination
and Certification of Death) Regulations provide further
conditions and criteria for the determination and certification
of brain death.
MTERA was passed by Parliament in 1973. It provides
for a person to pledge to donate his organs upon his death
for the purposes of therapy (including transplant), education
or research. Where a deceased person has not made any
indication of his intent to donate, MTERA also provides for
the relatives to donate the body or body parts of the
deceased person for the above purposes. Between 1973 and
1987, cadaveric kidneys for transplant were obtained either
under MTERA, or from overseas.
HOTA was introduced in 1987, as a presumed consent
law that allowed for the removal of kidneys for the purpose
of organ transplantation from those who died in a hospital
as a result of accidents, and did not object to organ donation
prior to their death. It applied to Singapore citizens and
permanent residents between the ages of 21 and 60 years.
Muslims were excluded from HOTA because of religious
reasons. Persons who were of unsound mind were also
excluded from HOTA. Persons who objected to organ
donation could opt not to donate their organs by registering
their objections with the National Organ Transplant Unit
(NOTU), a central national registry overseen by the Director
of Medical Services.
Several safeguards were provided for under HOTA.
First, the designated officer of the hospital had to ensure
that the necessary criteria required under HOTA were met
and provide his written authorisation before the organs
could be removed from a deceased person. The designated
officer had to be a senior doctor appointed by the Director
of Medical Services. Second, only medical practitioners
who had been authorised by the Director of Medical
Services could remove the organs from a deceased person
under HOTA and transplant these organs. Third, organ
trading was strictly prohibited.
Impact of HOTA
The introduction of HOTA resulted in more cadaveric
kidneys being available for transplantation.
3
Between 1970
and 1987, there was an average of 4.7 cadaveric kidney
transplants per annum. Between 1988 and 30 June 2004,
there was a total of 674 cadaveric kidney transplants or an
average of 40.8 cadaveric kidney transplants per annum
(Fig. 1). Of these, 13.5 cadaveric kidney transplants per
annum were obtained through HOTA during this period.
Necessity for Amendments to HOTA
When HOTA was first introduced, a conservative
approach was taken as Singaporeans were unfamiliar with
the concept of organ donation and there was cultural
reluctance to donate organs. HOTA was thus restricted to
only kidneys and death due to accidents. In addition, the
other types of organ transplant were not yet well developed
in Singapore.
However, with an increasing number of patients requiring
transplants, there was a need to review and revise HOTA
to alleviate the demand for more organs, including kidneys
as well as other vital organs such as the heart and liver. At
the same time, there was also a need to put in place an
effective regulatory framework for living donor organ
transplants, which till then had not been subject to any
legislative purview, even though the first living donor
kidney transplant in Singapore was carried out in 1976.
Although the Ministry of Health had established professional
guidelines stipulating that the social, psychological and
emotional profile of the donor had to be assessed, a full
medical examination carried out, and informed consent
taken, there was no legislation supporting these
requirements.
Demand for More Organs
Whilst the introduction of HOTA in 1987 had made more
cadaveric kidneys available for transplantation, this effect
was far outstripped by the growth in demand for kidneys,
as evidenced by the continued growth of the kidney
transplant waiting list. In 1988, there were 208 end-stage renal failure patients on the kidney transplant waiting list.
By end 2003, the waiting list had increased to 673 end-
stage renal failure patients (Fig. 2).
Likewise, there was also a shortage of livers and hearts
available for transplant. The first liver transplant and the
first heart transplant were only carried out in Singapore in
1990,
4,5
and hence liver and heart had not been included in
HOTA when it was first introduced in 1987. The organ
shortage resulted in a small number of liver and heart
transplants being carried out in Singapore. Between 1998
and 2003, there was only an average of 7.3 liver transplants
per annum and 1.8 heart transplants per annum. Due to the
shortage of organs, an average of 14.7 patients per
annum died while waiting for a liver transplant, and 2.7
patients per annum died while waiting for a heart transplant
(Table 1).
With regard to cornea transplants, Singapore relied heavily
on imported corneas, mainly from the United States of
America. Between 1998 and 2002, there were 861 cornea
transplants carried out in Singapore, of which 363 (42%)
transplants involved imported corneas. As imported corneas
might not be of optimal quality because of the long transit
time between the country of origin and Singapore, there
was a need to increase the local supply of corneas.
Amendments to HOTA
Following extensive public consultations spanning
January to September 2003, the HOTA Amendment Bill
was debated over 2 days in Parliament and passed
unanimously on 6 January 2004. The amendments to
HOTA were:
a. to extend HOTA beyond kidneys to include the liver,
heart and cornea;
b. to extend HOTA beyond death due to accidents to all
causes of death; and
c. to extend HOTA beyond cadaveric organ donation to
include living donor organ transplants.
The regulation of living donor organ transplants was
achieved through the addition of Sections 15A to 15D to
HOTA. These provided for the appointments and functions
of hospital Transplant Ethics Committees (TECs), and
required all living (both related and unrelated) donor organ
transplants to have prior written authorisation from the
TEC. The considerations of the TEC, in deciding whether
to approve an application of a living donor organ transplant
were to include whether there was (a) informed consent
from the donor, (b) presence of any form of organ trading,
or (c) presence of any “fraud, duress or undue influence”
when the informed consent was obtained from the donor.
In addition, the TEC was to “have regard to the
considerations of public interest and community values”,
to allow the TEC the breadth to take into account the
dynamic nature of societal expectations in a rapidly changing
medical arena.
Amendments to the Interpretation (Certification and
Determination of Death) Regulations
The Interpretation (Determination and Certification of
Death) Regulations were also amended to allow for the use
of supplementary tests in the determination of brain death.
The supplementary tests provided for were: (a) cerebral
angiography to confirm that there was no intracranial blood
flow; and (b) radionuclide scan to confirm that there was no
intracranial perfusion.
Impact of the Amended Human Organ Transplant Act
The revised HOTA came into effect on 1 July 2004.
Between 1 July 2004 and 30 June 2005, there was a total of
24 cadaveric organ donors, making available for
transplantation a total of 47 kidneys, 5 livers, 3 hearts and
33 corneas. Twenty-one donors (87.5%) came under HOTA,
while the other 3 donors came under MTERA. Among the
21 HOTA donors, 5 donors (23.8%) had deaths due to
accidents, while 16 donors (76.2%) had non-accidental
causes of death (Table 2). Supplementary tests were used
during brain death certification for 6 cadaveric organ
donors. Thus, the number of HOTA kidneys since the
amendment of HOTA has risen to 41 over the preceding
year. This compares to 13.5 cadaveric kidney transplants
per annum obtained through HOTA prior to the
amendments.
Discussion
The introduction of HOTA in 1988 led to an increase in
the number of cadaveric kidneys available for transplant.

This was similar to the experience in other countries with
presumed consent legislation.
6,7
However, despite the
increase in availability of organs, demand continued to
outstrip supply, with the waiting list for cadaveric kidneys
more than tripling between 1998 and 2003.
In the first year that it was implemented, the revised
HOTA resulted in an increase in the number of cadaveric
organs for transplant. Of the 21 cadaveric organ donors
who came under HOTA, 16 donors died from non-accidental
causes of death. Prior to the extension of HOTA beyond
deaths due to accidents to include all causes of death, those
who died from non-accidental causes of death would not
have been included under HOTA. Instead, organ donation
would have come under MTERA and would have required
consent from the donor’s family. Based on Sheehy et al’s
estimation of a consent rate of 54% for organ donation
8
and
NOTU’s estimate of a consent rate of 30% to 35% in
Singapore (personal communication with Ms Sally Kong,
Senior Manager, NOTU), it can be estimated that the
amended HOTA resulted in an additional 8 to 11 cadaveric
donors in its first year of operation.
The provision for supplementary tests under the
Interpretation (Determination and Certification of Death)
Regulations is likely to have also contributed to the increased
number of organ donors. If supplementary tests were not
available, the 6 donors where supplementary tests were
used might not have actualised as it might not have been
possible to perform some of the tests for brain death
certification, or the potential donor’s condition might have
deteriorated while waiting for the drug titres of depressant
drugs to go down.
Various factors have been suggested as possible
determinants of the organ donation rate in a country.
9,10
In
carrying out our policy review, we considered the possible
impact of these factors on the yield of organs. As HOTA
was originally limited to deaths due to accidents, we
examined the relationship between the number of deaths
due to accidents among Singaporeans and permanent
residents between the ages of 21 years and 60 years, and the
number of cadaveric kidneys obtained through HOTA. We
found no correlation between the number of accidents and
the number of cadaveric kidney transplants (Fig. 3).
Nonetheless, the lower yield of actualised donors over the
years could have been due to more accident victims either
dying at the site of the accident, or surviving due to better
management in the intensive care units at the hospitals.
With regard to the low organ donor rate in 2002, of the 8
potential HOTA donors identified, 5 potential donors
could not be actualised because they were found to be
medically unsuitable. The absence of any HOTA donors in
2003 is likely to be due to the impact of SARS and the
related policies implemented for infection control purposes.
200
180
160
140
120
No. of cadaveric kidney transplants
No. of deaths due to accidents
0
5
10
15
20
25
2002
2003
2000
1998
1993
1995
1996
1997
1991
1989
1994
2004
2001
1999
1992
1990
Fig. 3. Scatterplot of number of deaths due to accidents among Singaporeans
and permanent residents aged 21 to 60 years, and the number of cadaveric
kidney transplants obtained through HOTA, 1988-2004.
Source: Ministry of Health, Registry of Birth & Death and NOTU
There was extensive public consultation before we
proceeded with the amendments to HOTA. There are many
ethical and societal concerns with regard to presumed
consent legislation for organ donation
11-14
and it was
extremely important to take into consideration societal
views on organ donation and presumed consent legislation.
The public consultation on the proposed amendments to
HOTA spanned 9 months and the views of all major
religious groups, as well as various community and
professional groups were sought before the HOTA
amendment bill was presented and debated in Parliament.
There were also extensive public education campaigns
before and after the passage of the HOTA amendment bill
to inform the public of the amendments to HOTA as well
as organ donation.
In conclusion, based on the first-year experience, the
amended HOTA has helped to increase the yield of cadaveric
organs for transplantation. The kidney transplant waiting
list has also begun to shorten. Nonetheless, the organ
donation rates in Singapore still lag behind those in many
countries such as Spain, the United States and the United
Kingdom. The transplant community in Singapore will
need to identify further avenues to enhance the organ
transplant programme. In particular, we will need to explore
how the number of living donor organ transplants can be
enhanced to increase the supply of organs. The
implementation of a robust regulatory framework for living
donor organ transplants will thus allow us to move forward
with greater confidence in promoting living organ
transplants, thereby saving the lives of more patients.
Acknowledgement
We are indebted to Ms Sally Kong and Ms Ang Siang Eng, National Organ
Transplant Unit, for their assistance with the transplant data

REFERENCES
1. Rauff A. Renal transplantation in Singapore – a brief historical perspective.
Ann Acad Med Singapore 1991;20:556-8.
2. Soh P, Lim SM, Tan EC. Organ procurement in Singapore. Ann Acad
Med Singapore 1991;20:439-42.
3. Lim SM, Soh P, Woo KT, Rauff A. Organ donation in Singapore.
Transplant Proc 1990;22:2179-80.
4. Wai CT, Lo SK, Lee KH, Tan CK, Aw MM, Quak SH, et al. Ten years
of experience of liver transplantation in Singapore. Transplant Proc
2000;32:2139.
5. Sivathasan C. Experience with cyclosporine in heart transplantation.
Transplant Proc 2004;36:346S-348S.
6. Roels L, Coosemans W, Christiaens MR, Waer M, Vanrenterghem Y.
The relative impact of legislative incentives on multi-organ donation
rates in Europe. Transplant Proc 1995;27:795-6.
7. Michielsen P. Presumed consent to organ donation: 10 years’ experience
in Belgium. J R Soc Med 1996;89:663-6.
8. Sheehy E, Conrad SL, Brigham LE, Luskin R, Weber R, Eakin M, et al.
Estimating the number of potential organ donors in the United States. N
Engl J Med 2003;349:667-74.
9. Gridelli B, Remuzzi G. Strategies for making more organs available for
transplantation. N Engl J Med 2000;343:404-10.
10. Matesanz R. Factors that influence the development of an organ donation
program. Transplant Proc 2004;36:739-41.
11. Kennedy I, Sells RA, Daar AS, Guttmann RD, Hoffenberg R, Lock M,
et al. The case for “presumed consent” in organ donation. International
Forum for Transplant Ethics. Lancet 1998;351:1650-2.
12. Kluge EH. Improving organ retrieval rates: various proposals and their
ethical validity. Health Care Anal 2000;8:279-95.
13. Loewy EH. Presuming consent, presuming refusal: organ donation and
communal structure. Health Care Anal 2000;8:297-308.
14. Siminoff LA, Mercer MB. Public policy, public opinion, and consent for
organ donation. Camb Q Healthc Ethics 2001;10:377-