Legal and ethical aspects of organ donation and transplantation Dr.Nafeeya Department of Forensic Medicine &Toxicology
Indian Journal Of Urology SUNIL SHROFF DEPARTMENT OF UROLOGY AND RENAL TRANSPLANT ,SRI RAMACHANDRA MEDICAL COLLEGE & RESEARCH INSTITUTE ,PORUR,CHENNAI,INDIA
Overview Introduction Aim of the study In detail about the study Ethics of organ sale Limitation of the journal Discussion Conclusion
Scientific achievements of medical science. Organ transplantation is a gift of second life for thousand peoples of the world. It is possible to save many other lives Government make rules and act Lawful donation Brain-dead patients can be potential source for this purpose.
AIM OF THE STUDY By This article -try to awake awareness in general population. This article reviews the rules and Act related to organ donation program in India. Promoting the deceased donation program
The laws and rules governing organ donation and transplantation For living donation Mother, father, spouse, brother, sister ,son ,daughter Recently – grandparents Proof of their relationship –genetic testing /legal No need of Interview in front of committee
Brain death & its declaration Criteria -2 certificates required 6 hours apart from doctors 2 doctors Appropriate authority One of them being –neurologist
Role of Authorization Committee To regulate the process of authorization to approve or reject transplant To ensure that the donor is not being exploited for monetary consideration to donate their organ. To ensure that the donor understands the potential risks of the surgery Information about approval or rejection is sent by mail to the concerned hospitals
Role of Appropriate Authority To regulate the removal, storage, and transplantation of human organs. Licensed by the authority But eye donation - does not require any licensing procedure Inspecting and granting registration to the hospitals for transplant surgery 5yrs- renew after that Rights to cancel
Authority for removal of human organ Any donor may authorize the removal, before his death, of any human organ of his body for therapeutic purposes as specified in Forms 1(A), 1(B), and 1(C). The new forms- proof of identity, address, marriage registration certificate, family photographs, etc. with attestation by a Notary Public.
The donor is in a proper state of health and is fit to donate the organ. The registered medical practitioner should then sign a certificate as specified in Form 2. The donor is a close relative of the recipient as certified in Form 3 and has signed Form 1(A). The donor has submitted an application in Form 10 jointly with the recipient and the proposed donation has been approved by the concerned authority.
RMP –Before removing organ from deceased The donor had, in the presence of two or more witnesses authorized as specified in Form 5. The person lawfully in possession of the dead body has signed a certificate as specified in Form 6.
Brainstem death -RMP A certificate as specified in Form8-Board of Medical Experts. In the case of brain-stem death of a person of less than 18 years of age, a certificate specified in Form 8 has been signed by all the members of the Board of Medical Experts Form 9 has been signed by either of the parents .
Working guidelines for the Authorization Committee To check result of tissue typing & other tests NABL-National Accreditation Board for Laboratories Documentary evidence of relationship Married Non Indians –Senior embassy official should certify Check about commercial transaction –donor & recipient
Hospital based AC Medical Director or Medical Superintendent of the Hospital Two senior medical practitioners from the same hospital who are not part of the transplant team Two members of high integrity, social standing, and credibility Secretary (Health) or nominee and Director Health Services or nominee
State or district level AC Medical Practitioner officiating as Chief Medical Officer Two senior medical practitioners who are residing in the concerned district and who are not part of any transplant team Two senior citizens of high reputation and integrity residing in the same district Secretary (Health) or nominee and Director of Health Services or nominee
Ethics of organ sale Like child labour & prostitution Ethical and legal framework is mandatory Kidney donation –safe It affects the younger's donors health Potentially risk for long term ill health Sale is contrary to human dignity, and Sale violates equity.
Lawrence cohen Anthropologist from Berkeley Most of the donors were womens kidney belt region –southern India Poor rural womens To get money – support families No follow up care to prevent infection One way trade
Nancy scheper hughes Anthropologist from Berkeley THE END OF THE BODY :THE GLOBAL TRAFFIC IN ORGAN S FOR TRANSPLANT SURGERY Social suffering, violence,Motherhood ‘kidney sellers’ from impoverished communities in Recife. In her early investigations of an international ring of brokers and their living organ sellers based in New York, New Jersey and Israel led to a number of arrests by the FBI Bought sold Trade Stolen
Limitation of the study Does not mention the age limit Blood bank donation & tissue Transplant co-ordinator
NOTTO-NATIONAL ORGAN & TISSUE TRANSPLANT ORGANISATION
Harvard criteria of brain death Whole brain death Unreceptivity & unresponsivity No movements or breathing( apnoea for 3mins) Fixed dilated pupils No reflexes Flat EEG Repetition of test
Philadelphia protocol Lack of responsiveness Absence of spontaneous breathing movements No muscular movements No Reflexes & responses Falling arterial pressure Flat EEG Repetition of test Respirator must be put off
Minnesota criteria of brain stem death No spontaneous movement No spontaneous respiration Absence of 5 major brainstem reflex EEG NOT MANDATORY
APNOEA TEST FOR BRAIN STEM DEATH Mandatory test for brainstem death Definite loss of brain stem function If respiratory movements are absent and PaCO2 is ≥ 60 mm Hg Disconnection of Ventilators Raise PCO2 TO 60 mmHg 3-4 mm Hg under normal physiological Terminal illness
Scope of deceased donation program There are currently over 120 transplant centers in India Approximately 3,500 to 4,000 kidney transplants annually. 150 to 200 liver transplants annually Occasional heart transplant. Approximately 50 liver transplants are done from deceased donors and the rest are from living donors.
RTA- approximately 90,000 – 2005 Tamil Nadu 40-50% -the cause of death is head injury 5% to 10% of all these deceased patients became organ donors. No requirement for a living person to donate an organ. Promoting the deceased donation program Alternative to living organ transplant
Conclusion The transplantation act has evolved over last few decades. The latest rules are available on the website of Indian Society of Organ Transplantation as well. As transplant physicians and surgeons, students in the transplant program we should make ourselves aware of the existent rules. This will go a long way in avoiding legal issues in day‑to‑day transplant practice.
References Government of India. Transplantation of Human Organs Act, 1994. Central Act 42 of 1994. [cited 2007 Mar 9]. Cohen L.R. Where It Hurts: Indian Material for an Ethics of Organ Transplantation. Daedalus 1999;128:135-65. Shroff S, Navin S, Abraham G, Rajan PS, Suresh S, Rao S, et al. Cadaver organ donation and transplantation-an Indian perspective.Transplant Proc 2003;35:15-7. Shroff S. Working towards ethical organ transplants. Indian J Med Ethics 2007;4:68-9. Available from: http://www.easydriveforum.com/about_easydriveforum.