ORGAN TRANSPLANTATION IN INDIA & GLOBALLY By- Reethu Rajam
ORGAN TRANSPLANTATION IN INDIA & GLOBALLY
Authored By- Reethu Rajam
M.S. (IVth year B.Com LL.B(Hons.)
SASTRA University)
BACKGROUND
An organ transplant is said to be
a medical procedure attributed to transplantation of organ from a person who gives the organ
(also known as the donor) to a person who’s damaged organ needs to
be replaced (also known as the recipient). The globe has been evolving with
respect to the sphere pertaining to organ donation. The first transplant that
was successfully transplanted was the kidney in the 1954. Later, similar
procedures were practiced on liver, heart & pancreas by late 1960s,
followed by lung & intestinal organs in the 1980s. Fortunately, all these
procedures were a success. As these medical practices witnessed tremendous
success, the demand for organs shot up high. Organ Transplantation was a huge
asset to the medical industry but the core
ethics, moral practice & credo of the medical profession was said to
tested as commercial dealings began to rise exponentially. As a result,
regulations were formed to regulate the practices of organ transplantation
& organ donation to eradicate unfair practices.
LEGAL
FRAMEWORK IN INDIA
Transplantation
of Human Organs Act (THOA) was enacted in the year 1994 to provide with an
appropriate system that deals with organ transplantation & donation for
therapeutic purposes. Later, in 1995, the Transplantation of Human Organs Rules
were followed which was amended in 2014. The main aim of this act is to deal
with certain stages of the transplantation such as removal, storage,
transplantation & prevention of
commercial dealings with respect to human organs. One of the important
trait of this act was legalization of donation of organs by a brain dead
person. Some important provisions are said to be discussed below:
1. One of the
most important concept that was said to be introduced is ‘living donors’. A living donor can donate one kidney,
a portion of their liver or a portion of their pancreas. The
THO Act dictates who are eligible to donate organs without any legal
formalities and they are mother, father, brothers, sisters, grandmother,
grandfather, son, daughter and spouse.In an episode of transplantation, people
in this list, do not need any special permission or authorization from the
government. They are also called ‘first relatives’. Foreign
citizens, who are ‘near related’ to the recipient, are said to be permitted for
organ donation.
2. Secondly,
formulation of proper authorities in each state or Union Territory to oversee
and regulate transplant activities. They were done by the formulation of
Authorization Committee (AC), Appropriate Authority (AA) & Advisory
Committee.
(A) Authorization
Committee (AC) - The cardinal principle of this committee is that
the donor must not consider donation for consideration. If the total number of
transplants performed at the designated transplantation surpasses 25 in a year,
an authorization committee with a hospital in a metro area or major city shall
be formed. If there are less than 25 transplants in a district in a year, there
are State or District level Committees for small communities. The donor and the
recipient is said to fill an application. The application is said to be studied
& investigated which is followed by a personal interview. The motive of
this investigation is to understand if the donor recipient understands the
potential risks involved in the surgery & to ensure that there is no
plausible commercial transaction. The decision is made by following Sub Clause
(3), Clause 9 of Chapter II of THO Act and the approval or rejection is sent to
the respective hospitals.
(B) Approrprate
Authority (AA) - The
cardinal principle of this authority is regulation of removal, storage &
transplantation of human organs and make sure that these acts are performed
only after the approval. They are also entitled to check the standards of the
hospitals, examine if the hospital has a proper procedure for the
transplantation and if the hospital is making sure that the donors & the
recipients get proper follow up medical care.
(C) Advisory
Committee - The cardinal principle of this committee is to
advise the committees. They are constituted with a Chairman and 2 other medical
experts who possess a postgraduate degree, with not less than 5 years of work
experience in the sector of organ transplantation.
3. Thirdly,
Declaration of Brain Death. If a person is said to declared brain - dead when:
(a) His/Her
brain- stem functions have stopped working
(b) His/Her heart
maybe working due to external measures, like a ventilator.
In
such circumstances, there are 2 certifications that are required from 2 doctors
, one being a neurologist, who are nominated by the appropriate authority, 6
hours apart.
4. The fourth ingredient dealing with
organ donation is deceased or cadaver donors. When a person gives his or her
consent during their lifetime and if they are more they have attained majority,
then the organs of that person can be donated. With respect to the cost of
maintaining the body and other changes, for instance, retrieval of organs or
tissue, transportation of the organs & preservation of the organs shall be
borne will the recipient or the institution, as declared by the respective
state government.
5. Lastly, the act also includes certain
punishments. The following sections are:
(a) Section 18 states that a person who
is guilty of removal of a human organ or a tissue without the permission of the
prescribed authority can be slapped with a fine of Rs. 20,00,000/- and an
imprisonment upto 10 years. If the person found guilty is a medical
professional, they shall be reported to the State Medical Council and his or
her name shall be removed from the register for 3 years if it is a first
offense and if it is a repeated offense, then the name shall be removed
permanently.
(b) Any person dealing organs for a
consideration or commercial purposes shall be held guilty under Section 19 of
the the THO Act, for a period of 5 - 10 years and they shall be liable for a
fine of 20,00,000 - 1,00,00,000.
(c) If any other provision of the act is
said to be violated then they shall be punished under Section 20 with an
imprisonment that can extend upto 5 years or with a fine which can be extended
upto 20,00,000.
ISSUES
& CHALLENGES
There
has fashion with respect to organ transplantation has evolved tremendously.
There are a lot augmentation in surgical methodology, organ preservation, and
pharmaco-immunological therapies. In spite of such upgrades this sphere has
some critical issues that are not easy to get a handle on. There are a lot of
ethical, legal, cultural issues regarding organ transplantation.
Regarding
issues & challenges, there are 3 limbs to it:
(a) Ethical
Issues Regarding the Recipient: This issue
deals with the lifestyle of the candidate for transplantation. The question here is ‘Should people who have
refrained to maintain a healthy lifestyle by smoking, drinking, or diet receive
new organs? Should organs be given to people whose organs were damaged by
illness?’
(b) Ethical
Issues Regarding Allocation of Limited Resources: Since
there are a shortage of resources factors such as criteria for selection, usage
of animal organs (Xenotransplantation such as bovine heart transplant), usage
of artificial substitutes for tissues & organs, high costs,etc.
(c) Ethical
Issues Regarding Procurement of Organs & Tissues - Malpractices
are said to be momentous factor as far as ethical issues in organ donation are
concerned. In order to procure organs the concept of buying and selling organs
for consideration was a huge problem.
(d) Cultural
Barriers - Every culture has its own
myths, cultural misunderstandings, social values, death taboo etc.&
therefore it has also influenced organ donation.
DEMAND
& SUPPLY FOR ORGAN DONATION IN INDIA
Across
the world there is said to be a disequilibrium in the demand and supply
regarding organs. In India, there are a lot of factors that determine a
successful outcome in an organ transplant, such as, the consent of the family, the
decision making process, and psychological factors. There are about 4,00,000
people who die every year in India while waiting for an organ transplant.
Considering India’s population being 140.76 crores (as of 2021) there is an
enormous gap between the demand & supply. 185,000 kidneys, 33,000 livers,
and 50,000 hearts are required in India every year, yet only 6,000 kidneys,
1200 livers, and 15 hearts are transplanted there each year. According to the
Organ procurement of Transplant Network, one organ donor can save the lives of
almost eight other individuals.Unfortunately, when compared to a nation like
Spain, which has a donation rate of 36 PMP, India's rate of dead organ donation
is appallingly low at 0.34 per million people (PMP). This led to an organ
donation shortage in India, which can be solved even if only 5–10% of those
responsible for tragic accidents choose to donate their organs.
There
are some big challenges that India faces with reference to organ donation.
Firstly, Acceptance of Brain Death As Death. Families often find it hard to
believe that the patient is no more and they often tend to confuse with the
state of coma, which gives them hope. According to families, they are still
under the impression that the patient is still alive since the organs and
vitals are stable. This makes the family antipathetic to provide consent for
donation.
Secondly,
Need for Transplant Coordinators is censorious. A set of tests must
be performed on a brain dead person by four certified transplant coordinator in
order to determine and confirm the condition. Also, if a qualified transplant
coordinator is not present, this certification could not result in donations
because the conversion rate might be lower. The transplant coordinator must
address issues and offer advice to a possible donor family in addition to being
certified as a donor.
Thirdly,
Length between Death of the patient & Final Rites of the Patient. The
amount of time taken to harvest organs after a patient has been deemed
brain dead is one of the largest obstacles. Families of donors who have lost
their relative are frequently apprehensive when the patient's last rites
are delayed.
Fourthly,
The type of Consent, the final decision is made by the next of kin, but if the
family refuses, the organs of the deceased person cannot be donated.
Lastly,
Challenges regarding ICUs. The greater issue is the hospitals'
incapacity to recognize, certify, and keep track of a patient who has passed
away from brain death. With an estimated six out of ten patients willing to
donate, hospitals with transplant coordinators see an improvement in conversion
rates. Therefore, hospital ICUs must be set up to recognise, certify, and care
for individuals who have passed away from brain death. Only then can the
process of persuading a family be considered.
SITUATION
OF ORGAN TRANSPLANT IN OTHER COUNTRIES
Approximately
100 of the Member States of the World Health Organization (WHO) currently
report transplant services. Over 80,000 kidney transplants from both live and
deceased donors occurred in the world in 2014.
Spain
has always topped the list for highest donor rates in the world for 24 years.
As of 2015, with 39.7 donors per million, 4,769 transplants were performed and
one of the reasons why Spain has topped the list is because due to level of
organ donation in the country, the rate of refusal is very low as estimated in
2015 which is 15.3%.
In
the United States of America, with more than 42,800 organ transplants carried
out in the country in 2022, the number of transplants conducted there has been
rising steadily. Even with the rising numbers in transplant there is a serious
shortage of organs. About 121,678 people are waiting in the UNOS list for a
transplant. There were other measures taken in the US, for instance, Facebook users
were able to post their "donor status" to their accounts in 2013,
which increased registrations. In a more recent software upgrade for iOS 10,
Apple allowed American customers to register as donors directly from their
iPhones.
In
Brazil, the notion of organ donation was attempted through the presumed consent
model in 1997 but is was repealed after 8 years as there was a denunciation by
the public who had a fear that their organs will be removed before they were
clinically dead. Currently, Brazil opted
the system back and the rate of donation is 16 per one million people.
In
France, one of the main motives of the country is press upon Organ Donation. On
March 14, France launched a new €210 million strategy for organ and tissue
donation for the years 2022 to 2026. By 2026, the goal is to do 40% more
transplants, or a total of 6,760 to 8,530 transplants annually. 527 living
donors and 1,392 deceased donors combined for 5,273 organ transplants in France
in 2021. This represents a 19.3% increase over 2020, when the pandemic had a
significant negative impact on donations.
In
the Russian society places a high value on maintaining the integrity of the
deceased's body, making organ donation a particularly delicate topic. According to data
retrieved from the 2018 National Registry,
the number of organ transplants in Russia has been on a long-term upward trend,
increasing around 10-15% annually.
Iran is said to be the only country where it is legal to buy a kidney.
The government will compensate these unrelated contributors with money in the
amount of $1,200 and the recipient will
pay them an extra sum ranging from $2,300 to $4,500.
CONCLUSION
Organ
Donation is considered as ‘Life After Death’. There are a lot of factors that
causes a turbulence in this process, but beyond that there is an increase in
organ donation many countries. The law regarding organ donation is evolving
but, unexpectedly, medical students and nurses are unaware of the Act as well.
They, along with the rest of the community, must thus be better informed about
the Act. It has been shown that desire to give organs directly relates to
education level, which should be raised. Medical practitioners must establish
ethical standards and punish offenders. The committees that will monitor these
activities must include members who are representative of the general public.
References