Thursday , December 13 2018
Home / HEALTHCARE MANAGEMET / Legal / Human Organ Transplantation Act-1994
Organ Transplantation Organ Donation

Human Organ Transplantation Act-1994

An organ transplantation is the transplantation of a whole or partial organ from one body to another, for the purpose of replacing the recipient’s damaged or failing organ with a working one from the donor. Organ donors can be living, or cadaveric (dead).

History of Organ and Tissue Transplantation

The replacement of a worn-out organ by a new one is not a recent concept. There have been „reports‟ of organ transplantation in the Roman Empire and other ancient civilisations. Reports on tissue transplantation dating from the European Renaissance are more scientific. These concern tissue auto grafts which carry no risk of tissue rejection. It was not until a couple of centuries later that successful allograft was carried out. In the modern era organ transplantation sets off at the turn of the 20th century, with Alexis Carrel pioneering a method of joining blood vessels by replacing the artery with a segment of a vein. After this incident, organ transplantation had more scientific basis for its performance. Kidney was the first vital organs to be transplanted successfully in the year 1954.

The Transplantation of Human Organs Act, 1994

An Act to provide for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs and for matters connected therewith or incidental thereto.

Definitions-Organ Transplantation

  • “brain-stem death” means the stage at which all functions of the brain-stem have permanently and irreversibly ceased.
  • “deceased person” means a person in whom permanent disappearance of all evidence of life occurs, by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has taken place;
  • “donor” means any person, not less than eighteen years of age, who voluntarily authorizes the removal of any of his human organs for therapeutic purposes.
  • “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;
  • “near relative” means spouse, son, daughter, father, mother, brother or sister;
  • “recipient” means a person into whom any human organ is, or is proposed to be, transplanted;
  • “therapeutic purposes” means systematic treatment of any disease or the measures to improve health according to any particular method or modality;

Authority for the Removal of Human Organs

  • Any donor may, in such manner and subject to such conditions as may be prescribed, authorise the removal, before his death, of any human organ of his body for therapeutic purposes.
  • If any donor had, in writing and in the presence of two or more witnesses (at least one of whom is a near relative of such person), unequivocally authorized at any time before his death, the removal of any human organ of his body, after his death, for therapeutic purposes, the person lawfully in possession of the dead body of the donor shall, unless he has any reason to believe that the donor had subsequently revoked the authority aforesaid, grant to a registered medical practitioner all reasonable facilities for the removal, for therapeutic purposes, of that human organ from the dead body of the donor.
  • Where no such authority was made by any person before his death but no objection was also expressed by such person to any of his human organs being used after his death for therapeutic purposes, the person lawfully in possession of the dead body of such person may, unless he has reason to believe that any near relative of the deceased person has objection to any of the deceased person’s human organs being used for therapeutic purposes, authorise the removal of any human organ of the deceased person for its use for therapeutic purposes.
  • The authority given shall be sufficient warrant for the removal, for therapeutic purposes, of the human organ; but no such removal shall be made by any person other than the registered medical practitioner.
  • Where any human organ is to be removed from the body of a deceased person, the registered medical practitioner shall satisfy himself, before such removal, by a personal examination of the body from which any human organ is to be removed, that life is extinct in such body or, where it appears to be a case of brain-stem death.
  • Where any human organ is to be removed from the body of a person in the event of his brain-stem death, no such removal shall be undertaken unless such death; is certified, in such form and in such manner and on satisfaction of such conditions and requirements as may be prescribed, by a Board of medical experts consisting of the following, namely:
    • Registered medical practitioner, in charge of the hospital in which brain-stem death has occurred.
    • An independent registered medical practitioner, being a specialist, to be nominated by the registered medical practitioner
    • Neurologist or Neurosurgeon to be nominated by the registered medical practitioner
    • Registered medical practitioner treating the person whose brain-stem death has occurred.
  • Notwithstanding anything where brain-stem death of any person, less than eighteen years of age any of the parents of the deceased person may give authority, in such form and in such manner as may be prescribed, for the removal of any human organ from the body of the deceased person.

Authority for Removal of Human Organs

In the case of unclaimed bodies in hospital or prison

  • In the case of a dead body lying in a hospital or prison and not claimed by any of the near relatives of the deceased person within forty-eight hours from the time of the death of the concerned person, the authority for the removal of any human organ from the dead body which so remains unclaimed may be given, in the prescribed form, by the person in-charge, for the time being, of the management or control of the hospital or prison, or by an employee of such hospital or prison authorized in this behalf by the person in-charge of the management or control thereof.
  • No authority shall be given if the person empowered to give such authority has reason to believe that any near relative of the deceased person is likely to claim the dead body even though such near relative has not come forward to claim the body of the deceased person within the time.

For bodies sent for post-mortem examination

Where the body of a person has been sent for post-mortem examination –For medico-legal purposes by reason of the death of such person having been caused by accident or any other unnatural cause; or (b) For pathological purposes, the person competent under this Act to give authority for the removal of any human organ from such dead body may, if he has reason to believe that such human organ will not be required for the purpose for which such body has been sent for post-mortem examination, authorise the removal, for therapeutic purposes, of that human organ of the deceased person provided that he is satisfied that the deceased person had not expressed, before his death, any objection to any of his human organs being used, for therapeutic purposes after his death or, where he had granted an authority for the use of any of his human organs for therapeutic purposes after his death, such authority had not been revoked by him before his death.

Preservation of human organs

After the removal of any human organ from the body of any person, the registered medical practitioner shall take such steps for the preservation of the human organ so removed as may be prescribed.
Restrictions on removal and transplantation of human organs.

  • No human organ removed from the body of a donor before his death shall be transplanted into a recipient unless the donor is a near relative of the recipient.
  • Where any donor authorities the removal of any of his human organs after his death or any person competent or empowered to give authority for the removal of any human organ from the body of any deceased person authorizes such removal, the human organ may be removed and transplanted into the body of any recipient who may be in need of such human organ.
  • If any donor authorizes the removal of any of his human organs before his death into the body of such recipient, not being a near relative, as is specified by the donor by reason of affection or attachment towards the recipient or for any other special reasons, such human organ shall not be removed and transplanted without the prior approval of the Authorization Committee.
  • The Central Government shall constitute, by notification, one or more Authorization Committee consisting of such members as may be nominated by the Central Government on such terms and conditions as may be specified in the notification for each of the Union territories for the purposes.
  • The State Government shall constitute, by notification, one or more Authorization Committees consisting of such members as may be nominated by the State Government.
  • On an application jointly made, in such form and in such manner as may be prescribed, by the donor and the recipient, the Authorisation Committee shall, after holding an inquiry and after satisfying itself that the applicants have complied with all the requirements of this Act and the rules made there under, grant to the applicants approval for the removal and transplantation of the human organ.
  • If, after the inquiry and after giving an opportunity to the applicants of being heard, the Authorisation Committee is satisfied that the applicants have not complied with the requirements of this Act and the rules made there under, it shall, for reasons to be recorded in writing, reject the application for approval.

Regulation of Hospitals

Regulation of hospitals conducting the removal, storage or transplantation of human organs.

  • No hospital, unless registered under this Act, shall conduct, or associate with, or help in, the removal, storage or transplantation of any human organ;
  • No medical practitioner or any other person shall conduct, or cause to be conducted, or aid in conducting by himself or through any other person, an activity relating to the removal, storage or transplantation of any human organ at a place other than a place registered under this Act;
  • No place including a hospital registered shall be used or cause to be used by any person for the removal, storage or transplantation of any human organ except for therapeutic purposes.
  • The eyes or the ears may be removed at any place from the dead body of any donor, for therapeutic purpose, by a registered medical practitioner.

Prohibition of removal or transplantation of human organs for any purpose other than therapeutic purposes

No donor and no person empowered to give authority for the removal of any human organ shall authorize the removal of any human organ for any purpose other than therapeutic purposes.

Explaining effects, etc., to donor and recipient

No registered medical practitioner shall undertake the removal or transplantation of any human organ unless he has explained, in such manner as may be prescribed, all possible effects, complications and hazards connected with the removal and transplantation to the donor and the recipient respectively.

Appropriate Authority

  • The Central Government shall appoint, by notification, one or more officers as Appropriate Authorities for each of the Union territories for the purposes of this Act.
  • The State Government shall appoint, by notification, one or more officers as Appropriate Authorities for the purposes of this Act.
  • The Appropriate Authority shall perform the following functions, namely:
    • To grant registration or renew registration
    • To suspend or cancel registration
    • To enforce such standards, as may be prescribed, for hospitals engaged in the removal, storage or transplantation of any human organ
    • To investigate any complaint of breach of any of the provision of this Act or any of the rules made there under and take appropriate action;
    • To inspect hospitals periodically for examination of the quality of transplantation and the follow-up medical care to persons who have undergone transplantation and persons from whom organs are removed; and

Registration of Hospitals

Registration of hospitals engaged in removal, storage or transportation of human organs

No hospital shall commence any activity relating to the removal, storage or transplantation of any human organs for therapeutic after the commencement of this Act unless such hospital is duly registered under this Act,

  • Provided that every hospital engaged, either partly or exclusively, in any activity relating to the removal, storage or transplantation of any human organ for therapeutic purposes immediately before the commencement of this Act, shall apply for registration within sixty days from the date of such commencement
  • Provided further that every hospital engaged in any activity relating to the removal, storage or transplantation of any human organ shall cease to engage in any such activity on the expiry of three months from the date of commencement of this Act unless such hospital has applied for registration and is so registered or till such application is disposed of, whichever is earlier.

Suspension or cancellation of registration

The Appropriate Authority may, suo moto or on complaint, issue a notice to any hospital to show cause why its registration under this Act should not be suspended or cancelled for the reasons mentioned in the notice.

Offences and Penalties

Punishment for removal of human organ without authority

  • Any person who renders his services to or any hospital and who, for purposes of transplantation, conducts, associates with, or help in any manner in, the removal of any human organ without authority, shall be punishable with imprisonment for a term which may extend to five years and with fine which may extend to ten thousand rupees.
  • Where any person convicted is a registered medical practitioner, his name shall be reported by the Appropriate Authority to the respective State Medical Council for taking necessary action including the removal of his name from the register of the Council for a period of two years for the first offence and permanently for the subsequent offence.

Punishment for commercial dealings in human organs

  • Whoever
    Makes or receives any payment for the supply of, or for an offer to supply, any human organ
  • Seeks to find a person willing to supply for payment any human organ
  • Offers to supply any human organ for payment
  • Initiates or negotiates any arrangement involving the making of any payment for the supply of, or for an offer to supply, any human organ
  • Takes part in the management or control of a body of persons, whether a society, firm or company, whose activities consist of or include the initiation or negotiation of any arrangement
  • Publishes or distributes or causes to be published or distributed any advertisement,
    • Inviting persons to supply for payment of any human organ;
    • Offering to supply any human organ for payment; or
    • Indicating that the advertiser is willing to initiate or negotiate any arrangement

Shall be punishable with imprisonment for a term which shall not be less than two years but which may extend to seven years and shall be liable to fine which shall not be less than ten thousand rupees but may extend to twenty thousand rupees;