This article has been written by Hemant Bohra of Lovely Professional University, Punjab. This article discusses in detail the legality of kidney sales in India. It mentions the provisions of authority governing organ transplantation and kidney sales in the international market and provides a conclusive analysis of the cause and solution behind organ shortages with cases of organ trafficking in India.

It has been published by Rachit Garg.

Introduction

Do you know what the global prevalence of chronic kidney disease is? According to NCBI data, chronic kidney disease is estimated to cause approximately 735,000 deaths worldwide every year. Approximately 151 to 232 people in India are estimated to have an end-stage renal disease that requires transplantation.

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During the COVID-19 pandemic, there were several instances of illegal kidney transplantation and migration where people had lost their trust and faith in medical institutions, however, the Indian Government and recent amendments to its legislation have allowed intensive care doctors to make a “required request” for organ donation in the event of brain death and taken various measures to curb this illegal trafficking of organs.

Kidney sale and transplantation

Food, clothing, a virtual world tour, a blockchain, and even organs may all be purchased for a very high price in today’s society. A kidney costs roughly Rs. 5 to 6 lakhs in India, depending on how urgently it is needed. Even though the sale of human organs is prohibited in the nation, the demand for kidneys is so high that open internet forums thrive despite efforts to stop it. And, because people giving their kidneys are frequently in dire need of cash, they are more than prepared to sell immediately if the price is right.

Over long-term dialysis, kidney transplants are the medically preferred therapy for kidney failure. Kidney transplants were done for the first time in 1936 and are now the most prevalent type of organ transplant. Studies have shown kidney transplantation to extend life well beyond what is expected with dialysis. The average patient should expect to live ten to fifteen years longer after a kidney transplant than she would if she continued on dialysis. Patients in their twenties who receive a kidney transplant should expect to live thirty years longer than dialysis patients.

Demand and supply of organs in India

According to recent data from the  Health Resources and Services Administration (HRSA), 17 people die every day while waiting for an organ transplant and there are currently between 1 lakh and 6 thousand people on the national transplant waiting list, which makes India the country with the lowest rate of organ donations in the world. Even though public health institutions handle more accident trauma patients than private institutions, big, multi-center private hospitals are driving the increase in donations and transplants, while numbers at government hospitals remain low. According to experts, public hospital facilities must be vastly upgraded before contributions and transplant operations can expand.

The lack of awareness is one of the most significant barriers to organ transplantation and donation. Ignorance, superstition, and sorrow are all significant barriers that prevent families from allowing post-mortem organ donation. State government awareness efforts are still in their infancy. A single gift from a deceased donor whose brain died before their heart might save the lives of up to eight patients with end-stage organ failure. 

If India’s donation rates were increased to one donation per million deaths, the country’s organ demand would be fully met, and for that, individuals need to be aware of the importance of such a delicate issue. However, while governmental and private organisations are striving to bridge the gap between donors and recipients through programs like Jeevandaan, there is still a great need for individuals to be encouraged to come forward and donate to save someone’s life.

new legal draft

Authority monitoring removal of organs

The Transplantation of Human Organs Act (THOA), 1994

In 1994, India established the Transplantation of Human Organs and Tissues Act, which aimed to make organ donation and transplantation more efficient. In general, the Act recognised brain death as a kind of death and made the selling of organs illegal. With the admission of brain death, it became possible to begin solid organ transplants such as the liver, heart, lungs, and pancreas, in addition to kidney transplants. The Act’s primary objective is to prohibit commercial deals in human organs by regulating the removal, storage, and transplantation of human organs for medicinal purposes. Under the Act, certain people can donate their organs, which include:

  • A donor who is a close relative (mother, father, son, daughter, brother, sister, spouse).
  • Other than a close familial donor such as relatives, who can only donate out of love and attachment or for any other particular cause with the agreement of the authorisation committee.
  • Deceased donor, especially after the death of the brain stem, such as a victim of an unpredictable incident.

The Act contains detailed provisions relating to the authority for the removal of human organs, the protection of human organs, the regulation of hospitals conducting the removal, storage, or transplantation of human organs, the functions of the appropriate authority, and the prosecution for offenses relating to the aforementioned matters. However, due to challenges faced in regulating the Act, it was needed to make it stricter, so the government amended the provisions in 2011.

The 2011 Amendment

The 2011 Amendment Act allows for organ swapping and expands the list of potential donors by adding grandparents and grandchildren. This legislation had a few significant revisions, which are listed below:

  • Under the modified Act, ‘Recovery Centres’ would be established for the retrieval of organs from dead donors and their registration.
  • The brain death certification board has been streamlined, and more specialists are now allowed to participate in the process.
  • The term “close relative” has been broadened to encompass grandparents and grandchildren.
  • A mandatory ‘Transplant Coordinator’ is responsible for organising all aspects of human organ removal and transplantation.
  • In the tragic event of the brain stem death of an ICU patient for the purpose of organ donation, a ‘mandatory’ inquiry and informative choice to donate is required.

Organ donation, on the other hand, bears major moral and ethical requirements in India, which is not the case in other industrialised nations. Organ trafficking and migration are two illicit acts that have grown globally under the guise of organ donation.

Application Form 1

An identified living near related can fill the below mentioned Application Form 1 to apply for Organ Donation:

Application Form 3

A person other than a near relative living donor can apply for organ or tissue donation through Form 3 which is mentioned below:

According to National Organ & Tissue Transplant Organisation, there are several other application forms that are required for different subject matter such as Form 2 is for organ or tissue donation by a living spouse, Form 14 is for registration of tissue banks other than eye and Form 11 is for approval of transplantation from living donor.

National Organ and Tissue Transplant Organisation (NOTTO)

With the introduction of the NOTTO in 2015, the 2011 Amendment to the THOA 1994 laid the groundwork for the development of the NOTTO, which has been critical in regulating organ donation and transplantation in India.

The major goal of this organisation’s formation is to promote deceased’s  organ/tissue donation in order to supply tissues and organs for transplantation to people in need. It also intends to set up an effective system for procuring organs and tissues from dead donors and distributing them for transplantation.

The organisation establishes policy guidelines and practices for a variety of services, including data administration, organ transplant surveillance, and organ donor registry.

It collaborates with ROTTO (Regional Organ and Tissue Transplant Organisation) and SOTTO (State Organ and Tissue Transplant Organisation), as well as other organisations that regulate organ and tissue transplantation.

A successful case of kidney transplantation

During the pandemic, NOTTO with the support of its subsidiary organisations provided help to various citizens who were in need, one such example is a 35-year-old woman in Kauvery Hospital, in this case, the patient was diagnosed with IgA Nephropathy, which meant that his kidney function was declining and that he needed a transplant right away. The donor was identified as the patient’s mother. All transplant-related studies were completed, and both the recipient and the donor were deemed to be appropriate. In the meanwhile, the mother and daughter had COVID-19 symptoms such as a minor cold, fever, and cough. Their CT scans were normal, therefore they were placed under home quarantine.

They tested negative after recovery, and testing on their antibody levels revealed a strong response to Covid infection, indicating they were effectively protected from subsequent COVID-19 infection. After kidney transplantation, the donor (mother) and patient were discharged.

Organ Procurement Organisations (OPOs)

Organ procurement organisations (OPOs) are non-profit organisations dedicated to the acquiring of organs for transplantation. They are the organisations having the legal ability to recover organs from deceased donors, as well as provide support to donor families, clinical care for organ donors, and professional and public education on organ donation. 

Other specific responsibilities include identifying potential organ donors, receiving consent from donors’ families, acquiring organs, partnering with other organisations to discover potential transplant recipients, and ensuring that organs are delivered to transplant institutions. Organ India and MOHAN Foundation are examples of OPOs.

Authority setup for regular inspection of organ transplantation

According to  Section 13 of Chapter IV of Human Organ Transplantation Acts, it is the duty of the Central Government to appoint one or more officials as Appropriate Authorities (AA) for each of the Union Territories for the registration and regulation of human organ and tissue transplantation.

Authority for removal of human organs

Any donor may authorise the removal of any human organ from his body for medical reasons before his death, according to Chapter II, Section 3 of the Transplantation of Human Organs Act of 1994. The donor must attest to his mental and physical fitness and sign the relevant certificate form. In order to get approval from the Authorisation Committee, the donor must also define the relationship with the recipient by signing Form 1(B) (for the donor’s spouse) and Form 1(C) (for anybody other than a close relative) (AC) in the presence of two witnesses. 

Before removing a human organ from a person’s body in the event of brain-stem death, a registered medical practitioner must confirm that the certificate outlined in Form 8 has been signed by all members of the Board of Medical Experts, as well as the person’s parents if the person is under the age of 18.

Appropriate Authority (AA)

This body’s job is to oversee the removal, storage, and transplantation of human organs. Only after receiving a licence from the authorities a hospital can be allowed to engage in such operations. The AA’s powers under Chapter IV, Section 13 B, include inspecting and registering hospitals for organ transplants, conducting regular checks of hospitals to focus on the quality of transplantation, carrying out medical care for donors and recipients, dismissing or cancelling the registrations of defaulting hospitals, and investigating complaints about violations of the Act’s provisions.

Authorisation Committee (AC)

The goal of this group is to control the permission procedure for approving or rejecting transplants between the recipient and non-first-degree relatives. The committee’s major responsibility is to guarantee that the donor is not exploited for monetary gain by donating their organ. The recipient and donor’s combined application is investigated, and a personal interview is required to convince the AC of the donor’s real motivation for donation and to verify that the donor is aware of the surgery’s possible dangers. The affected hospitals get notification of approval or rejection by mail.

Guidelines for the composition of AC

The Central Government is required by the Transplantation of Human Organs Act (THOA) to form a State Level Authorisation Committee. The donor and beneficiary will get permission or a no objection certificate from AC in order to establish legal and residential status in a certain state. Furthermore, if the number of transplants at the individual transplantation facilities surpasses 25 per year, an AC should be hospital-based in metros and major cities. If the number of transplants in a given district is less than 25, state or district-level committees will be formed.

Working guidelines for the Authorisation Committee

Guidelines are provided by the  National Organ & Tissue Transplantation (NOTTO) Act for the working of the Authorisation Committee (AC) that are mentioned below:

When a planned transplant is between genetically related people (mother, father, brother, sister, son, or daughter over the age of 18), the following criteria must be considered:

  1. Any member involved in an organ transplantation operation is not allowed to be a part of the Authorisation Committee.
  2. If the donor and recipient are not Indian citizens, the link between the donor and the receiver must be certified by a senior embassy official from the donor’s home country. 
  3. The Authorisation Committee must review the findings of tissue type and other basic procedures, such as blood testing, if the donor and beneficiary are family members. The AC will also look for identifying documents such as a PAN card, a bank account, a driver’s licence, and so on. If the identity documents are insufficient, AC has the option of undergoing further medical exams that have been approved by the National Accreditation Board for Laboratories (NABL).
  4. If the intended donor and the receiver are not close relatives, the Authorisation Committee must determine that the beneficiary and the donor are not involved in a business transaction. With the use of identification documents, AC must examine any relationship between the parties and analyse the grounds for the donor’s desire to contribute.
  5. The AC shall declare in writing why it is rejecting or granting the intended donor’s application by evaluating all medical tests of the donor to establish his biological capacity and compatibility to donate the organ. Before reaching a final decision on whether to give authorisation or refuse a transplant, the AC must check for the fulfilment of all needed forms.

Composition of hospital-based AC

The hospital-based Authorisation Committee includes:

  1. Chairperson – Medical Director or Medical Superintendent or Head of the Hospital.
  2. Members – Two senior medical practitioners who aren’t part of the transplant team from the same hospital.
  3. Member – Two people of high integrity, social standing, and credibility who have served in high-ranking government positions, such as the higher judiciary, senior police cadre, or as a reader or professor in a UGC-approved university. 
  4. Member – Secretary of Health or a nominee, and Director of Health Services or a nominee from the state government or the administration of a union territory.

Composition of state or district level ACs

The members of a state or district level ACs are no different, subject to a few positions that include:

  1. Chairperson – A medical practitioner serving as Chief Medical Officer or any other comparable position in the district’s primary government hospital.
  2. Members – Two senior registered medical practitioners chosen from a pool of such practitioners who live in the affected district and are not members of any transplant team.
  3. Members – Two people of high integrity, social standing, and credibility who have served in high-ranking government positions, such as the higher judiciary, senior police cadre, or as a reader or professor in a UGC-approved university.
  4. Member – Secretary of Health or a nominee, and Director of Health Services or a nominee from the state government or the administration of a union territory.

Kidney sale outside India

Transplant tourism is becoming more popular as the demand for transplantable kidneys grows and wait periods get longer. Only a few nations have legalised organ sales. Patients who are in urgent need or are unable to wait for organ donation in their native countries but have the financial means to search for organs overseas commonly receive cadaveric or living donor transplant surgery in underdeveloped nations.

Patients who buy kidneys on the foreign market usually get them from live donors, so their kidneys last longer than those who wait for a legitimate cadaveric kidney transplant through an organisation that procures and distributes organs from the deceased. 

Given the enormous number of lives at risk, many patients, physicians, and organ brokers are unconcerned about the high level of illegality of the exchange of cash for kidneys, which is very high. However, cutting out the intermediary, the Internet, and certain hospitals that buy organs directly from donors are helping recipients save money in these international transactions.

Many nations, including Israel, South Africa, China, Russia, and Brazil, do not strictly enforce their anti-organ-sale legislation. For example, Japanese people buy organs in the Philippines, Israelis from Turkey, or former Soviet Union states. Despite the fact that India has prohibited kidney sales since 1994 with the institutionalisation of the Transplantation of Human Organs Act, patients continue to find donors prepared to accept deals in return for donating a kidney. Donors can escape legal repercussions by submitting an affidavit claiming they have not been paid.

Say of religious practices in kidney sale

Organ donation is a personal decision that is not outlawed under Hindu law in India, just as it is not prohibited under Islamic law, which places a major emphasis on preserving human lives. Despite occasionally imposing a few requirements, most major global faiths take a neutral stance concerning an individual’s decision to donate. However, when it comes to allowing people to sell their organs, religious officials’ viewpoints are more aligned. Even people who do not oppose organ donation are generally opposed to the selling of organs.

In 1996, a group of academics from all of Britain’s main Muslim law schools determined that “Organs should be given rather than sold. Receiving payment for an organ is illegal.” Indeed, eminent Muslim professor Muhammad Al-Munajjid declared at the time that the Islamic Fiqh Council had issued a fatwa (religious judgment) declaring that trading in human organs is prohibited under any circumstances. However, whether a recipient may spend money to receive an organ he requires or to express gratitude is still a point of contention among academics.

Reasons for supporting prohibition of kidney sale

Decrease in altruistic donation

If kidney sale is authorised, altruistic donation would undoubtedly decline since individuals would want to earn money in return for their organs. Giving individuals financial incentives to accomplish something, for example, weakens or reduces the level to which they feel ethically obligated to perform that thing  and just like that money  reduces the possibility of generosity in this way.

Domination of rich over poor

Legitimising the sale of organs would certainly result in a society where only the wealthy could benefit from life-saving organ transplants, while the impoverished would be the primary donors of those organs. It means that rich individuals will have a better chance of receiving a kidney than poor people, causing an inequity issue. Furthermore, “brokers” would contact the people, facilitating arrangements between the possible donor and beneficiary in exchange for a large commission.

Exploitation of life

A person’s life might be put in jeopardy for monetary gain as selling kidneys would not only take advantage of individuals in financial need, but it would also set them up for future, potentially life-threatening complications. Any time a person undergoes surgery, there is a risk of death since there is no guarantee that the remaining kidney will not cause difficulties later in life. 

Increase in crime rate

The fear is that legalising the kidney will lead to a rise in criminal activity throughout the world, as individuals would want to kill others in order to sell their organs for a large sum of money. Furthermore, allowing the sale of kidneys would lead to the formation of new fraudulent businesses that would remove people’s organs but not pay them the fee.

Legalising kidney sale

The entire case for legalising organ trafficking appears to be intrinsically unethical: profiting off your own body parts, which are a part of your identity. However, allowing a legal kidney market to operate offers its own set of advantages. Some of them are as follows:

Increase in supply of kidneys

Because people are more likely to sell a kidney rather than give one, a licensed market will boost the supply of living kidneys. Iran has authorised the selling of kidneys, making it the only country in the world where any patient, regardless of their economic condition or educational background, can undergo a kidney transplant. Once the long waiting list for organ transplants is reduced, India will get back on track.

Good quality kidneys will be available

Patients will obtain healthier kidneys and live longer as a result of this, since recipients of living kidneys live an average of 12 to 20 years longer than recipients of deceased donor kidneys. Because a big supply means the ability to pick among the best kidneys available, an increasing supply will also mean an improvement in kidney quality.

Reduction in cost

Before obtaining a kidney, most patients are on dialysis for around 5 years. If organ trade were allowed, patients would pay a lower price for a kidney and its transplantation, and they would not have to pay the additional expense of dialysis because the kidney would be delivered on time. Further, due to the availability of organs in the market, customers can bargain the price for the kidney.

Reduction in illegal organ trafficking

Foreign illegal markets will be dissolved if organ trade markets become legal in other countries, and many individuals of impoverished nations, in particular, will no longer be subject to the control of organ trade crime rackets.

Headliner cases on organ trafficking

Doctors charged in kidney trafficking racket

In a recent case at a Mumbai-based hospital, following the discovery of a kidney trafficking ring, the chief executive, medical director, and three other physicians at a famous Indian hospital were charged with illicit organ transplant offences. During their employment tenure, complaints of negligence under the 1994 Transplantation of Human Organs Act were filed against these doctors, according to a report by a Mumbai director of health services.

After a colleague reported odd documents for a planned procedure in which a lady was giving a kidney to her husband, police discovered the racket. During the procedure, they stormed the hospital and discovered that the couple was not married and that the donor was a destitute rural lady from a neighbouring state. However, the doctors were released by the court and imposed stipulations.

Kidney racket busted in a Delhi-based hospital

In another case, five people were arrested on charges of running a kidney scam transporting donors from all across the country to the national capital, including two staff of a famous multispecialty hospital in south-east Delhi and three others. The racket was caught in June when police discovered a couple fighting outside the hospital and arrested them. The lady had unlawfully donated a kidney, and the case eventually led to the discovery of a wider organ scam. Police had detained 13 persons before the end of July.

The police have identified the secretarial staff of certain doctors who are not hospital workers as being involved in the suspected scam as part of their investigation. Despite taking all reasonable steps, fraudulent and counterfeit papers were employed in this scam with criminal intent.

Gurgaon kidney trafficking scam

Hundreds of impoverished labourers have been deceived into giving their organs in the Gurgaon Kidney Scam, which is one of the largest illicit kidney transplant rackets in Indian history. People from all across northern India were transported to Gurgaon and had their kidneys removed in a private property with a state-of-the-art operating theatre hidden inside. The doctors were said to have conducted around 400 or 500 kidney transplants in the preceding years and were arrested.

A total of 50 medical personnel, excluding five foreigners, may have been implicated in the scam, with the majority of them fleeing the country. Many victims said they were lured to the residence with the promise of a job, only to be misled or forced to sell their kidneys under duress.

Assam organ trafficking racket

In the recent case, the Assam police uncovered an illegal human organ sale network in Morigaon district, arresting three people, including a mother and her son. At Dakshin Dharamtul town in Central Assam’s district, the arrested woman and her associates were running an illicit kidney trade. They enticed about 20 poor villagers by promising to pay them Rs 4-5 lakh if they donated a kidney to some sick persons or organisations.

The racket was discovered after some village residents captured the mother and her son as they were searching for potential kidney dealers in the area on Saturday. They were eventually given up to the police by the townspeople.

Conclusion

Organ sales, often known as organ trading, is a sad reality in most parts of the country. While there are a few stories of real charity, poverty and debt are almost always the driving forces for unrelated live donors. In India, the body enforcing the laws is lagging behind in enforcing stringent rules and regulations addressing the illegal selling of organs. The Transplantation of Human Organs and Tissues Act, 1994 itself has some flaws. If the law itself is enacted to help people who are in need of organs, why are there so many conditions/limitations applied to donating organs between a recipient and a donor?  

There is a significant gap between the demand for and supply of human organs and tissues for transplantation in the country. One of the most severe effects of kidney selling is that kidneys are sold for a handsome amount in India, and as a result, altruistic donors are falling out of the market and becoming organ dealers. Either the Indian Government legalise the selling of kidneys or it must take immediate action to address this crucial issue.

Frequently Asked Questions (FAQs)

What is the “No Objection Certificate” under organ donation?

When a donor donates out of love, compassion, or devotion to the recipient, there is no financial transaction between the donor and the receiver, and there is no influence or compulsion on the donor, a no objection certificate is issued.

What is a living donation?

When a living individual gives an organ (or part of an organ) for transplantation to another person, it is known as a living donation. When compared to people who get a deceased donor kidney, recipients of a living donor kidney tend to live longer and better lives.

Is a minor who is below 18 years of age allowed to donate organs?

A child under the age of 18 years needs parental consent for organ donation. Further, in the case of Anshita Bansal v. Secretary, Ministry of Wealth of Health and Family Welfare, 2020, the Delhi High Court ruled that a juvenile giving an organ or tissue before reaching majority with parental authorization is not a “complete prohibition.”

How long does it take for a person to have a kidney transplant?

The average waiting period for a first kidney transplant is 3.6 years, however, this might vary based on the patient’s health, compatibility, and organ availability.

References


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