THE TRANSPLANTATION OF HUMAN ORGANS ACT, 1994 (1).pptx

transplantation

1. THE TRANSPLANTATION OF HUMAN ORGANS ACT, 1994

2. This Act was enacted in 1994 (amended in 2011 and 2014) for the removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs. 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.

3. Authority for removal of human organs 1. Any donor (≥18 years of age) may authorize the removal before his death of any organ of his body for therapeutic purposes. 2-. If any donor had in writing (in presence of 2 or more witnesses) or in documents like driving license 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. 3. When no such authority is there, person lawfully in possession of dead body can authorize the removal of any organ including eye/cornea of the deceased person.

4. 4. When human organ is to be removed, the medical practitioner should satisfy himself that life is extinct in such body or in case of brainstem death, it has been certified by: i. The doctor in-charge of hospital in which the brainstem death has occurred. ii. An independent doctor, being a specialist nominated by the above in-charge from the panel of names approved by Appropriate Authority. iii. A neurologist or a neurosurgeon, nominated by the in-charge from the panel. iv. 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.

5. Removal of human organs cannot be authorized wherein: i. An inquest may be required to be held in relation to such body. ii. A person who has been entrusted the body solely for the purpose of cremation. Authority for removal of human organs in case of unclaimed bodies in hospital or prison: ❖ If not claimed by any near-relatives within 48 hours (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.

6. Authority for removal of organs from bodies sent for postmortem or pathological examination: Person competent under this Act can give authorization, if such organ is not required for the purpose for which the body has been sent. Donation in Medico-legal Cases: After the authority for removal of organs and/or tissues, and consent to donate from a brainstem dead are obtained, the RMP should make a request to the SHO of the area, either directly or through the police post located in the hospital to agree for retrieval of organs from the donor. It has to be ensured that, by retrieving organs, the determination of the cause of death is no jeopardized. In cases where the definite cause of death is established clinically by the RMP, the postmortem may be waivec off by the competent officer on the request of the RMI and Investigating Officer (IO) of the case.

7. The RMP who is designated to do the postmortem can do the organ retrieval also. Otherwise, he should be present at the time of retrieval of organs/tissues by the retrieval team. The postmortem report in respect of the organs/tissues being retrieved should be prepared at the time of retrieval. Rest of the postmortem procedure should take place at the autopsy room. For the purpose of organ(s)/tissue(s) retrieval, request for postmortem beyond specified timings, can be made by the RMP and IO of the case.

8. Restriction on Removal and Transplantation of Human Organs i. 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*. ii. When donor authorizes the removal of his organs after his death, the organs may be transplanted into the body of any recipient. iii. 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.

9. Regulation of hospitals conducting the removal, storage or transplantation of human organs i. Hospital not registered under this Act should not be engaged in transplantation activities. ii. Medical practitioner should not conduct transplanta- tion at any unregistered place under this Act. iii. The eyes and the ears may be removed at any place from dead body of any donor for therapeutic purposes by a doctor. Removal of eye can be done by a trained technician to facilitate eye donation. The doctor is also prohibited from removal of transplantation of human organs for any purpose other than therapeutic purposes. Offences and Penalties a.Punishment for doctor on removal of human organs without authority i. Punishable with imprisonment for 10 years and fine up to 25 lakh. ii. Removal of his name from the register of State Medical Council for a period of 3 years for the 1st offence and permanently for the subsequent offence. b.Punishment for commercial dealings in human organs ent, Punishable with imprisonment for a term from 5 to 10 years and fine of 20 lakh to 1 crore.

10. Duties of the Medical Practitioner Regarding Organ Transplantation: 1. 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 BC is in proper state of health and fit to donate the organ. c. Donor is a near-relative of the recipient and sign a certificate after carrying out following tests on donor and recipient: 1. Tests for the antigenic products of HLA-A, HLA-B and HLA-DR using conventional serological techniques. ii. Tests to establish HLA-DR Band HLA-DQ ẞ gene restriction fragment length polymorphisms.

11. iii.When the above tests do not establish genetic relationship, tests to establish DNA polymor- phisms 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. d. In case recipient is a spouse of donor, record the statements of both and sign a certificate. e. In case of a donor not being a near-relative, the permission from the Authorization Committee has been obtained. f. If a donor and/or recipient is/are foreign nationals, the approval of the Authorization Committee has been obtained

12. I I. In case of cadaveric donation, the doctor should satisfy himself that: i. Donor has authorized before his death, the removal of his organ for therapeutic purpose, in presence of two or more witnesses, at least one of whom is a near-relative. ii. Person lawfully in possession of dead body has signed a certificate as III. A doctor, before removing organ from a brainstem dead person, should satisfy that: i. Certificate regarding the brainstem dead from the board of medical experts is present. In case of non- availability of a neurosurgeon or a neurologist to certify brain death, an intensivist or anesthetist can be included on the medical board. It is mandatory for the ICU/treating medical staff to request rela- tives of a brain dead patient for organ donation. ii. In case of a person <18 years, a certificate has been signed by either of the parents of such person. Living organ/tissue donation by minors is not permitted, except on exceptional medical grounds and with prior approval of the Appropriate Authority and the Government

13. AUTHORIZATION COMMITTEE: i The medical practitioner involved in organ transplantation team should not be a member of the Authorization Committee ii. In case of foreigners, where the transplant is between a married couple, the Committee must evaluate the factum and duration of marriage and verify documents such as marriage certificate iii. Transplantation is not permitted if the recipient is a foreign national and donor is an Indian national, unless they are near-relatives. iv. When the proposed donor and the recipient are not 'near-relatives, the Committee should evaluate that: a. there is no commercial transaction between the recipient and the donor; the following is specifically assessed:

14. link between them and the circumstances which led to the offer being made. reasons why the donor wishes to donate. documentary evidence of the link, e.g., proof that they have lived together. old photographs showing the donor and the recipient together. b. there is no middleman or tout involved. c. financial status of the donor and the recipient, evidence of their vocation and income for the previous three financial years. d. donor is not a drug addict.e. next of the kin of unrelated donor is interviewed regarding awareness about his/her intention to donate an organ and/or tissue, the authenticity of the link between the donor and the recipient and the reasons for donation.

15. ETHICAL ISSUES IN ORGAN DONATION: Setting Safety Standards Faith & Personal values Transparency of rules for allocation of organs Equality of access in transplant services Checking commercialization