AASASS

1. THE TRANSPLANTATION OF HUMAN ORGANS ACT (1994) Issues, Challenges and Possible Solutions Dr. VIPIN KOUSHAL ASSISTANT PROFESSOR PGIMER Chandigarh AASASS Assisted by Dr. Navin Pandey

2. Transplantation is the future of medicine THOA Prosecution • Improved technology • Better medicines Legal & Ethical issues • Increased awareness • Increasing waiting list Illegal trade Exploitation

3. Need for the Act • Patients requiring transplantation increasing. • No corresponding increase in organ donation • Lead to black marketing & organ trading • Huge susceptible population that can be exploited Contd....

4. THOA • Provides for the regulation of : • Removal • Storage • Transplantation • Of human organs & tissues for therapeutic purposes, and • For the prevention of commercial dealings in human organs

5. THOA (Amendment) Act 2011 • Includes donation of tissues. • Organ swapping legalised. • Penalties enhanced. • Grandparents and Grandchildren included in the list of near relatives.

6. THOA (Amendment) Act 2011 • In the absence of a neurologist or neurosurgeon : • An independent surgeon or physician • An anesthetist or intensivist • Maybe nominated for brain death declaration • Makes it mandatory for a doctor in an ICU to ascertain if a family wants to donate organs • No organs or tissues shall be removed from a mentally challenged person before his death.

7. THOA (Amendment) Act 2011 • Transplantation involving a foreign national, even if near relatives requires approval by AC. • National registry of donors and recipients. • Cornea, can be retrieved by a certified eye technician

8. THOA (Amendment) Act 2011 • NGOs registered specially to work on human organ transplantation would be allowed. • Mandatory to appoint a transplant coordinator in registered hospitals

9. The Authorities Two authorities have been formed under the Act: • Appropriate Authority (AA) and • Authorization Committee (AC)

10. Constitution of AA The Central and State Governments shall appoint, by notification, one or more officers as Appropriate Authorities for purposes of this Act.

11. Role of AA • To grant registration to a hospital • To suspend or cancel such registration. • To enforce standards of registered hospitals • To investigate any complaint or breach of any provision of the Act (Contd....)

12. Role of AA • AA has the power to: • Summon any person • Seek production of a document • Issue a warrant for the search of any place • Suspected to be indulging in unauthorized transactions in human organs.

13. Constitution of AC • The composition of the AC is such as may be prescribed by the Central Government. • The State Government and the Union territories shall constitute, • One or more ACs • Consisting of members nominated by the State Governments and the UTs.

14. A senior person officiating as a Director or MS or CMO • 2 senior medical practitioners from same hospital who are not part of the team. • 2 members being persons of high integrity, social standing & credibility • Secretary health or nominee& DGHS or nominee • 2 senior medical practitioners who are residing in the state but not part of transplant team. • 2 senior citizens of nonmedical background.

15. Role of AC • Approve transplants between unrelated donors and recipients • NOC from their respective country’s embassy if the donor or recipient is a foreign national • NOC from respective domicile states, if donor or recipient are from different states.

16. Punishment For violation of act by medical professionals • Imprisonment of 10 years • Fine of Rs. 5 lacs • Removal from the medical council roll for two years for the first offence and permanently for any subsequent offence. Commercial dealings will invite an • Imprisonment ranging from 5-10 years • Fine between 20 lakh to 1 crore

17. Types of donor as per THOA DONOR Deceased donor Live donor Live related Live unrelated ‘near relative’ means ‘spouse, son, daughter, father, mother, brother or sister, grandparents & grandchildren Swapping

18. Live related donor • Medical practitioner certifies that the donor is in a proper state of health and is fit to donate • Donor has to give his authorization in appropriate Form 1(A) or 1(B) • Donor has to submit an application in (Form 10) jointly with the recipient. • Necessary medical tests to determine the factum of near relationship.

19. Spousal donorRule 4-A(2) • Joint application by donor & recipient with certificate of proof. • Approval by the authorization committee.

20. Live unrelated donor (Contd....) • The AC ensures that there is no commercial transaction or middle man / tout involved • Financial status of the donor and the recipient • Next of the kin of the proposed unrelated donor is interviewed • Seeks an explanation of : • link between the donor and recipient. • Documentary evidence of the link

21. Deceased donation • Authorised medical board has to certify that patient is brain dead. • A medical board comprises of: • Hospital Administrator, • A neurologist or neurosurgeon (an independent surgeon or physician, and an anesthetist or intensivist.) • And the patient’s treating doctor.

23. CASE STUDY 1 ORGAN TRANSPLANT IN PGIMER

24. INITIATION Future: Pancreas, Intestines

25. Authorization Committee Prof. A. K. Gupta, MS-cum-Head, Deptt of Hospital Administration, PGIMER, Chd Secretary Health U.T Admn or his nominee Director Health Services U.T Admn or his nominee Dr. (Mrs.)Saroj Sharma, Prof Medical Microbiology Prof Rajinder Singh HOD, Surgery, PGIMER. Prof. Deepak BhasinDeptt of Gastro, PGIMER Prof.(Retd) KN PathakVice Chancellor, Punjab University Mr. P. C. Dogra, DGP (Retd.)

26. ISSUE Initiating the Heart Transplant Program in PGIMER

27. CHALLENGES • INFRASTRUCTURE • TRAINED & QUALIFIED MANPOWER • REGISTRATION • ORGAN DONOR • ORGAN RECEIPIENT • CHALLENGES FOR MANAGEMENT

28. Solution • Application in Form 11 justifying the • Infrastructure • Manpower. • Inspection by team from DGHS • Registration granted .

29. Solution : Organ recipient • Waiting list prepared • 5 patients put on the waiting list

30. Solution : Donor • Road traffic accident victim in PGIMER on 30th JULY 2013 • Potential brain dead donor • Information from the treating doctor about potential brain death status of patient • Hospital SOP activated

31. Identifying potential donor Counselling & Motivation Brain death certification Consent Arrangements for organ harvesting Liasoning with the police Arranging for the postmortem, early release of the body & transport. Recipients and arrangements for transplant.

32. Solution First successful heart transplant at PGIMER on 4th august 2013

34. Case Study 2 ORGAN TRANSLANT & ALLEGATION AGAINST AN INSTITUTE

35. ISSUE • X complained to NHRC that Y who was well known to him took him to PGIMER, Chandigarh . • Y threatened X to donate his kidney for Y’s wife. • Doctors at PGIMER were also involved in this.

36. FACTS Report sent to NHRC with the following explanation: • The centre strictly performs kidney transplantation from related donors only as per the provisions of THOA. • The transplant was carried out after approval by the AC of Bihar state.

37. SOLUTION : FACTS • X voluntarily registered as the patient’s younger brother and was a willing kidney donor. • The recipient and the donor were evaluated in the Deptt. of Nephrology for medical fitness and establishment of relationship between the donor and the recipient after approval by AC.

38. SOLUTION : FACTS • The complainant had obtained a travelling concession form for Chandigarh with a fake name. • A number of doctors, nurses, technicians, paramedical staff interacted with the donor and not once did he complain.

39. Solution • NHRC dismissed the case. • Proper documentation saved the day for PGIMER.

40. CASE STUDY 3 ORGAN TRANSPLANT LIVE AND CADAVERIC

41. ISSUE • Patient with attempted suicide was admitted at a reputed Corporate Hospital (CH), in Mohali • Patient had a head injury, put on ventilator, poor prognosis explained to family • Family motivated to donate the organs of their young patient. • Transplant team of the institute informed of the family’s decision.

42. Challenge • CH was conducting only living donor transplants. • CH did not have a Brainstem Death Certification Committee approved by the AA

43. CHALLENGE • There was no forensic expert available at the Hospital. • The forensic expert had to be deputed by the AA (civil Surgeon)- this process was time consuming and involved a legal clearance from the government.

44. Solution • Patient shifted to PGIMER on request and the process for organ donation started • CH informs the institute that one kidney & liver were required for patients on their waiting list.

45. SOLUTION • PGIMER not in position to do the liver transplant as recipient not available • The patient’s family decided to donate only kidneys .

46. SOLUTION • Any hospital having live organ transplant program should be prepared for cadaver organ transplant. • Brain stem death certifying committee should be identified and approved by the AA. • Formalities for conducting autopsy should be available as most of brain dead cases are MLC cases.

47. SOLUTION • Collaboration with national level NGOs . • Transplant team has to be in a state of alert with a ready updated recipients list .

48. Case Study - 4 DolmaBhuti & another ....................Petitioners Vs PGIMER, Chandigarh &others............Respondents CASE NO : Appeal (Civil) 11977 of 2012 DATE OF JUDGMENT: March 28th , 2008 ORGAN TRANSPLANT & DOMICILE OF DONOR/RECIPIENT

49. ISSUE • Petitioner No.1 (resident of Tibet) - studying in Tibetan Children Village School at Dharamshala. • Developed CRF due to Nephrotic Syndrome • Petitioner No.2 – A Buddhist monk (resident of HP) decided to donate his one kidney out of compassion to save Petitioner 1’s life.

50. ISSUE • The patient had reached a stage where she required daily dialysis at PGIMER. • Only solution was urgent transplant surgery • PGIMER seeks clearance by AC of HP as the petitioners were residents of HP.