A short presentation of Human Organ Transplantation. Focusing majorly on Medicolegal aspects.

1. Presented by: Guided by:
Dr. Santo M.S. Dr. S.M. Jawale
Resident Doctor Associate Professor
Department of Forensic Medicine Department of Forensic Medicine
and Toxicology and Toxicology
Grant Government Medical College Grant Government Medical College
Mumbai. Mumbai
HUMAN ORGAN
TRANSPLANTATION

2. Contents
1. INTRODUCTION
2. HISTORY OF TRANSPLANTATION
3. TRANSPLANTATION OF HUMAN ORGAN ACT, 1994
4. RECENT ADVANCES
5. REFERENCES

3. Introduction
● Organ transplantation is one of the major medical achievements of the 20th
century.
● Nowadays, many diseased organs are being replaced by healthy organs from
living donors, cadavers, and from animal source.
● Successful bone marrow, kidney, liver, cornea, pancreas, heart, nerve cell and
other transplantations have taken place.
● The incidence is limited only by cost and availability of the organs.
● The discovery of effective immunosuppressive drugs in the late 1970s was an
important step toward increasing the success rate of organ transplants and
thus paved the way for organ transplantation to become a medical routine
affair in the twenty-first century.

4. History of Organ Transplantation

5. Lore
First written mention of transplant is
seen in- Ebers Papyrus, written circa
1550 BC, which mentioned skin grafting
for the treatment of burns.
Around 600 BC, the Indian surgeon
Sushruta, known as the father of
surgery, is credited with performing the
first plastic surgery operations, including
full-thickness skin grafts.

6. In “The Miracle of the Black Leg,” from Jacobus De
Voragine’s 348 AD Legenda Aurea,
limb transplantation was first mentioned in written
literature.
In this story, the Christian patron saints of medicine,
pharmacy, and surgery, Cosmas and Damian, replace
the cancerous leg of a Roman deacon with that of a
recently deceased Ethiopian man.

7. In 1817, French physician Henri Dutrochet
wrote a letter to the editor of Gazette de
Santé on skin transplant, based on a story
from his brother-in-law, an army officer
stationed in India.
According to the letter, an army subordinate
had been punished by having his nose cut off.
The man sought out locals well versed in skin
grafting and known for their ability to
surgically reconstruct a nose, and he asked
them to operate on him.

8. Modern Medicine
First verifiably documented skin
transplant - 1869.
Swiss surgeon Jacques-Louis Reverdin
demonstrated success with epidermic
grafting.

9. ● First-ever successful kidney transplant
● Dr Thomas Murray
● honoured with a Nobel Prize in Medicine
● 1954.
● India's first kidney transplant
● Dr. P.K. Sen and his team at King Edward Memorial Hospital,
Mumbai
● May 1965.

10. ● First human lung transplantation
● Dr. James Hardy’s team
● University of Mississippi
● 1963.
● First Lung Transplant in India.
● Dr. Jnanesh Thacker, Program & Surgical
Director - Heart, Lung, Heart & Lung
Transplantation & Assist Devices, Yashoda
Hospitals, Hyderabad.
● 11th July 2012.

11. ● The first liver transplant in the world.
● Dr. Thomas Starzl.
● University of Colorado.
● 1967.
● First Liver transplant in India.
● Dr. R.P. Shanmugam.
● Department of Surgical Gastroenterology at
Stanley Medical Hospital.
● 1996.

12. ● World's first human-to-human heart transplant
operation
● Christiaan Neethling Barnard was a South African
cardiac surgeon.
● On 3 December 1967.
● Human heart transplant in India.
● Panangipalli Venugopal.
● All India Institute of Medical Sciences (AIIMS), New
Delhi.
● August 3, 1994.

13. Transplantation of Human Organs and Tissues Rules, 2014
TRANSPLANTATION OF HUMAN ORGANS
ACT, 1994 &

14. 1. The primary legislation related to organ donation and
transplantation in India, Transplantation of Human
Organs Act, was passed in 1994.
2. The Act was initiated at the request of Maharashtra,
Himachal Pradesh and Goa.
3. Subsequently adopted by all states except Andra
Pradesh and Jammu &Kashmir.
4. The Act was amended in 2011.

15. Till 1994 there was no comprehensive nationwide legislation to regulate the removal of
organs from deceased or living persons.
There were only some state level legislation and that pertaining only to specific organ
In Delhi
● The eye act 1982
● The eardrum and ear bone act 1982
In Maharashtra
● The Bombay corneal grafting act 1957
● The Maharashtra kidney transplantation act 1982

16. FEATURES OF THE ACT
● Regulation of removal, storage, and transplantation of human organs for
therapeutic purposes and for the prevention of commercial dealings in human
organs.
● Illegalizes the buying and selling of human organs.
● Establishes an institutional structure.
● Recognizes the concept of brain-stem death.

17. Some important definition under act
1.Brain stem death- Stage at which all the functions of
brain stem have permanently and irreversibly ceased.
2.Human organ - Under this Act 'human organ' means
any part of a human body consisting of a structured
arrangement of tissues which, if wholly removed,
cannot be replicated by the body.

18. Human Organ retrieval centre
Means a hospital
● Which has adequate facilities for treating seriously ill patients who can be
potential donors of organs in the events of death
● Which is registered U/s 141 for retrieval of human organs
Near relatives
In the original act there were following seven relations
1. Father 2. Mother 3. Spouse 4. Brother 5. Sister 6.Son 7. Daughter

19. By the 2011 amendment following four relations were added
1. Grand father 2. Grand mother 3. Grand sons 4. Grand daughter
Tissue- means of a group of cells except blood performing a particular functions in
human body. This subsection has been added by 2011 amendment and brings bone
marrow within the purview of the act.
Tissue bank- means a facility registered us 14A for carrying out any activity relating
to the recovery, screening, testing processing, storage and distribution of tissues,
but does not include blood bank (added by 2011 amendment)

20. Transplant coordinator-
means a person appointed by the hospital for coordinating all matters relating to
removal or transplantation of human organs or tissues or both and for assisting the
authorities for removal of human organs in accordance with the provisions of Act.

21. Appropriate authority(AA)
Central government and state governments should appoint AA comprising of one
or more persons.
functions of AA are:
● To grant registration and renew registration to hospital.
● To suspend and cancel registration.
● Enforce high standard for hospital and tissue bank.
● To investigate complaints into irregularities take action.
● To periodically inspect hospitals and tissue bank.

22. Authority for removal of human organs
● Any donor (> 18 years of age) may authorize the
removal before his death of any organ of his body
for therapeutic purposes.
● If any donor had in writing (in presence of 2 or
more witnesses): authorized the removal of any
organ after his death for therapeutic purposes,
the person lawfully in possession of dead body
should allow the doctor all reasonable facilities for
removal.

23. ● When no such authority is there, person lawfully in possession of dead body
can authorize the removal of any organ of the deceased person.
● When human organ is to be removed, the medical practitioner should satisfy
himself, that life is extinct in such body or where it is a case of brainstem death.

24. "Authorisation Committee'
"Composition of Authorisation Committees"-
(1) There shall be one State level Authorisation Committee.
(2) Additional Authorisation Committees in the districts or Institutions or hospitals
may be set up as per norms given below, which may be revised from time to time
by the concerned State Government or Union territory Administration by
notification.
(3) No member from transplant team of the institution should be a member of the
respective Authorisation Committee.

25. (4) Authorisation Committee should be hospital based if the number of transplants
is twenty five or more in a year at the respective transplantation centres, and if the
number of organ transplants in an institution or hospital are less than twenty-five in
a year, then the State or District level Authorisation Committee would grant
approvals).

26. "Composition of hospital based Authorisation
Committees":-
The hospital based Authorisation Committee shall, as notified by the State
Government in case of State and by the Union territory Administration in case of
Union territory, consist of,-
(a) The Medical Director or Medical Superintendent or Head of the institution or
hospital or a senior medical person officiating as Head - Chairperson;
(b) Two senior medical practitioners from the same hospital who are not part of the
transplant team - Member;

27. C) Two persons (preferably one woman ) of high integrity, social standing and
credibility, who have served in high ranking Government positions, such as in
higher judiciary, senior cadre of police service or who have served as a reader or
professor in University Grants Commission approved University or are
self-employed professionals of repute such as lawyers, chartered accountants,
doctors of Indian Medical Association, reputed non-Government organisation or
renowned social worker - Member;
(d) Secretary (Health) or nominee and Director Health Services or nominee from
State Government or Union territory Administration - Member.

28. "Composition of State or District Level Authorisation
Committees"-
(a) A Medical Practitioner officiating as Chief Medical Officer or any other equivalent
post in the main or major Government hospital of the District -Chairperson;
(b) Two senior registered medical practitioners to be chosen from the pool of such
medical practitioners who are residing in the concerned District and who are not
part of any transplant team- Member;

29. (c) Two persons (preferably one woman) of high integrity, social standing and
credibility, who have served in high ranking Government positions, such as in
higher judiciary, senior cadre of police service or who have served as a reader or
professor in University Grants Commission approved University or are
self-employed professionals of repute such as lawyers, chartered accountants,
doctors of Indian Medical Association, reputed non-Government organisation or
renowned social worker - Member;
(d) Secretary (Health) or nominee and Director Health Services or nominee from
State Government or Union territory Administration-Member:

30. Procedure for donation of organ or tissue in medicolegal
cases
As per Transplantation of Human Organs and Tissues Rules, 2014
(1) After the authority for removal of organs or tissues, as also the consent to donate
organs from a brain-stem dead donor are obtained, the registered medical
practitioner of the hospital shall make a request to the Station House Officer or
Superintendent of Police or Deputy Inspector General of the area either directly or
through the police post located in the hospital to facilitate timely retrieval of organs
or tissue from the donor and a copy of such a request should also be sent to the
designated post mortem doctor of area simultaneously.

31. 2) It shall be ensured that, by retrieving organs, the determination of the cause
of death is not jeopardised.
(3) The medical report in respect of the organs or tissues being retrieved shall
be prepared at the time of retrieval by retrieving doctor (s) and shall be taken
on record in postmortem notes by the registered medical practitioner doing
postmortem.

32. (4) Wherever it is possible, attempt should be made to request the designated
postmortem registered medical practitioner, even beyond office timing, to be
present at the time of organ or tissue retrieval.
(5) In case a private retrieval hospital is not doing post mortem, they shall
arrange transportation of body along with medical records, after organ or
tissue retrieval, to the designated postmortem centre and the post mortem
centre shall undertake the postmortem of such cases on priority, even beyond
office timing, so that the body is handed over to the relatives with least
inconvenience.

33. The death has to be certified by:
1. The doctor in-charge of hospital in which the brainstem death has occurred.
2. An independent doctor, being a specialist nominated by the above in-charge
from the panel of names approved by Appropriate Authority.
3. A neurologist or a neurosurgeon, nominated by the in-charge from the panel.
4. The doctor treating the person whose brainstem death has occurred.
Under any circumstances, brainstem death tests should not be performed by
transplant surgeons or any doctor in the transplant team or a member of the
Authorization Committee.

34. Removal of human organs cannot be authorized wherein
An inquest may be required to be held in relation to such body.
A person who has been entrusted the body solely for the purpose of cremation.

35. Authority for removal of human organs in case of unclaimed
bodies in hospital or prison
● If not claimed by any near-relatives within 48 h from time of death, the
authority lies with the management of hospital or prison or by employee of the
hospital or prison authorized by management
● If there is reason to believe that any near-relative of the deceased person is
likely to claim the body even beyond 48 h, no authority should be given.

36. Restriction on removal and transplantation of human organs
● Human organ should not be removed from the body of donor before his death
and transplanted into recipient, unless the donor is a near-relative.
● When donor authorizes the removal of his organs after his death, these organs
may be transplanted into the body of any recipient.
● If any donor authorizes the removal of his organs before his death to such
recipient not being near relative by reason of affection or attachment towards
the recipient, the organs should not be removed and transplanted without prior
approval of Authorization Committee.

37. Regulation of hospitals conducting the removal, storage or
transplantation of human organs
● Hospital not registered under this Act should not be engaged in
transplantation activities.
● Medical practitioner should not conduct transplantation at any unregistered
place under this Act.
● The eyes and the ears may be removed at any place from dead body of any
donor for therapeutic purposes by a doctor.
● The doctor is also prohibited from removal or transplantation of human organs
for any purpose other than therapeutic purposes.

38. Punishment for commercial dealings in human organs
Punishable with imprisonment
for a term from 2-7 years and
fine of 10,000-20,000.

39. Duties of the Medical Practitioner Regarding
Organ Transplantation
In case of live donation, the doctor should satisfy himself before removing an organ
from the donor that:
a. Donor has given his authorization.
b. Donor is in proper state of health and fit to donate the organ.

40. c. Donor is a near-relative of the recipient and sign a certificate after carrying out following tests
on donor and recipient:
i. Tests for the antigenic products of HLA-A, HLAB and HLA-DR using conventional
serological techniques.
ii. Tests to establish HLA-DR and HLA-DQ gene restriction fragment length polymorphisms.
iii. When the above tests do not establish genetic relationship, tests to establish DNA
polymorphisms using at least two multilocus genes probe.
iv. When (iii) do not establish genetic relationship, further tests to establish DNA
polymorphisms using at least five single locus polymorphism probes.
In case recipient is a spouse of donor, record the statements of both and sign a certificate.

41. In case of cadaveric donation, the doctor should satisfy himself that:
● Donor has authorized before his death, the removal of his organ for
therapeutic purpose after his death, in presence of two or more witnesses, at
least one of whom is a near-relative.
● Person lawfully in possession of dead body has signed a certificate as
specified under the Act.

42. A doctor, before removing organ from a brainstem dead person, should satisfy that:
● Certificate regarding the brainstem dead from the Board of medical experts is
present.
● In case of a person < 18 years, a certificate has been signed by either of the
parents of such

43. Recent advances

44. Availability of new-era Immunosuppressants and induction therapy
The invention of immunosuppressants therapy was a breakthrough in transplant surgery.
Azathioprine was the first drug that when given with prednisolone enabled transplantation of unrelated
donor organs successfully.
This was followed by the development of better drugs such as
● ciclosporin,
● tacrolimus,
● sirolimus,
● everolimus,
● Mycophenolic acid
which resulted in better survival outcomes in transplant patients.
Biological agents such as monoclonal or polyclonal antibodies are now used along with
immunosuppressants to enable dose reduction of immunosuppressants without the risk of organ rejection.

45. Improved organ preservation
Organ preservation <4°C and the use of the specialised preservative solution for
different organs have helped to reduced tissue damage and optimal organ
preservation in vivo until transplant.
Moreover, several advanced surgical procedures are used during organ extraction
to cause minimum damage to organs in brain dead donors.

46. Robot assisted kidney transplantation
● The traditional operation for the kidney recipient surgery is the open operation
which involves a large incision in the abdomen.
● Robot Assisted kidney transplant is a new technique which allows the recipient
surgery to be performed using the minimally invasive technique.
● This technique is associated with less post operative pain, lesser risk of
post-surgical infections, quick recovery and early discharge from the hospital.

47. Future directions
● Development of invitro organs
● Xenotransplantation
● Improved organ preservation
● Pre-transplant treatment
● Organ preconditioning
● Face, uterus, and extremity transplants
● Improved organ transportation

48. WORLD ORGAN DONATION DAY

49. References

50. 1. Schmidt VH (2003) Transplant medicine as borderline medicine. Med Health Care
Philos 6:319-321.
2. The history of organ transplantation - Kristen D. Northampton, BA and Scott
Ninokawa, BS
3. Transplantation of human organs act, 1994.
4. Transplantation of Human Organs and Tissues Rules, 2014
5. Thongprayoon C, Kaewput W, Pattharanitima P, Cheungpasitporn W. Progress and
recent advances in solid organ transplantation. J Clin Med [Internet]. 2022 [cited
2023 Feb 13];11(8):2112. Available from: http://dx.doi.org/10.3390/jcm11082112.
6. Cascalho M, Ogle BM, Platt JL. The future of organ transplantation. Ann Transplant
[Internet]. 2006 [cited 2023 Feb 13];11(2):44–7. Available from:
https://pubmed.ncbi.nlm.nih.gov/17494288/

51. THANK YOU!