Law > Medical Jurisprudence > The Transplantation of Human Organs and Tissues Act
In India there are many health legislations e.g., Drugs and Cosmetics Act,1940, The Prevention of Food Adulteration Act, 1954, The Medical Termination of Pregnancy Act, 1971, Maternity Benefit Act,1961, Insecticides Act 1968, Narcotic Drugs and Psychotropic Substances Act and Rules 1985, The Pre-Natal Diagnostics Techniques Act, 1994, Food Safety and Standards (Contaminants, Toxins and Residues) Regulations, 2011, Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011, amongst others. In this article we shall discuss one such Act called the Transplantation of Human Organs and Tissues Act, 1994.
With the advent of advanced medical technology in transplant procedures an end stage organ failure patients got a ray of hope to lead a healthy and prolonged life by undergoing organ transplant. Human body has certain essential organs like kidneys, lungs, cornea that are in pairs, making it possible to part away with one of the two during the lifetime and still be able to lead a healthy life. Whereas other significant organs like heart, pancreas etc. can be used only after the death of a human being but before the organs become obsolete on account of discontinuation of blood supply. There are regenerative and non-regenerative transplantable tissues/organs like liver, blood, bone marrow, stem cells etc. To facilitate transplants for saving the lives of organ failure patients and to safeguard the interests of the organ donors, the Transplantation of Human Organs and Tissues Act was passed in India in 1994. Various organs can be legally transplanted by virtue of the Transplantation of Human Organs and Tissues Act, 1994 giving gift of life to people otherwise doomed to die on account of failure of vital organs.
The Act relates to the regulation, storage, and transplantation of human organs for therapeutic purposes and prevention of commercial dealings of human organs. This Act provide guidelines and rules regarding who can give or donate the organs as well as who can receive the organ and how should the organ donation should take place. This Act for the first time in India recognized the brain stem death under some guidelines.
Historical Background of the Act:
Transplantation of Human Organs Bill, 1992 was introduced in Lok Sabha on 20 August 1992. This Bill was assented by the President on 08 July 1994. It became ‘The Transplantation of Human Organs Act’, 1994 (42 of 1994). The Act was enacted on February 4, 1995, in the states of Goa, Himachal Pradesh, and Maharashtra and all the union territories. Thereafter, all states adopted these regulations, with the exception of the states of Jammu and Kashmir and Andhra Pradesh, which they had enacted their own legislation. Presently The Transplantation of Human Organs Act, 1994, is applicable to all over India
Objects of the Transplantation of Human Organs and Tissues Act, 1994:
The objects of the Transplantation of Human Organs and Tissues (TOHO) Act, 1994 are as follows:
- 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.
- To illegalize the buying and selling of human organs and makes cash-for-kidney transactions a criminal offence.
- To establish an institutional structure to authorize and regulate human organ transplants and to register and regulate, through regular checks, hospitals that are permitted to perform transplants.
Salient Features of the Transplantation of Human Organs and Tissues Act, 1994?
- There are 7 Chapters and 25 Sections in the Act.
- The Transplantation of Human Organs and Tissues Act, 1994 is meant 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. The Central Act illegalizes the buying and selling of human organs and makes cash-for-kidney transactions a criminal offence.
- The law establishes an institutional structure to authorize and regulate human organ transplants and to register and regulate, through regular checks, hospitals that are permitted to perform transplants.
- It recognizes, for the first time in India, the concept of brain-stem death, paving the way for a cadaver-based kidney transplant programme.
- The Act details actions that amount to direct participation in or abetment of the organ trade; these offences are punishable under Section 19 of the Act.
- The Act defines two categories of donors:-
- First, it permits a near relative, defined as a patient’s spouse, parents, siblings, and children, to donate a kidney to the patient.
- Secondly, in Section 9(3) of the Act, live donors who are not near relatives but are willing to donate kidneys to the recipients by reason of affection or attachment towards the recipient or for any other special reasons, are permitted to do so, provided that the transplantations have the approval of the Authorization Committee, established under the Act.
- The Act makes the offence of kidney trading non-cognizable. In other words, the police cannot look into complaints of kidney trading independently but must wait for a complaint to be made by the Appropriate Authority set up under the Act or by an officer authorized by it or by an individual who has given prior notice of not less than 60 days to the Appropriate Authority.
- It is not clear whether Section 9(3) was deliberately meant – under pressure from special interests – to provide a loophole that could be exploited in practice, or whether the law-makers thought they were sympathetically making provision for donations from second-degree relatives and others who might act out of genuine love and affection or altruism. But whatever be the reasoning and motivation behind the provision of a loophole, the practical operation of Section 9(3), combining with the non-cognizability of the offences to be prosecuted, has rendered the 1994 Act virtually unenforceable.
- The Act very sensibly provides for registration of hospitals claiming to have the necessary competence and facilities to perform particular organ transplantation. This is a regulatory measure intended to protect the interests of patients. It is with the Appropriate Authority, set up by the State government under the Act, which hospitals intending to do transplants must register. Approvals are granted only after the institutions fulfill certain technical, infrastructural and medical requirements.
Important Definitions in the Transplantation of Human Organs and Tissues Act, 1994:
- Brain-Stem Death: According to Section 2(d), “brain-stem death” means the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under sub-section (6) of section 3 of the Act.”
- Deceased Person: According to Section 2(e), “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: According to Section 2(f), “donor” means any person, not less than eighteen years of age, who voluntarily authorises the removal of any of his human organs for therapeutic purposes under sub-section (1) or sub-section (2) of section 3 of the Act”
- Hospital: According to Section 2(g), “hospital” includes a nursing home, clinic, medical centre, medical or teaching institution for therapeutic purposes and other like institution.
- Human Organ: According to Section 2(h), “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: According to Section 2(i), 1994, defines near relatives as ““near relative” means spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter”
- Recipient: According to Section 2(m), “recipient” means a person into whom any human organ or tissue or both is, or is proposed to be, transplanted;
- Registered Medical Practitioner: According to Section 2(n), “registered medical practitioner” means a medical practitioner who possesses any recognized medical qualification as defined in clause (h) of section 2 of the Indian Medical Council Act, 1956 (102 of 1956), and who is enrolled on a State Medical Register as defined in clause (k) of that section;
- Therapeutic Purposes: According to Section 2(o), “therapeutic purposes” means systematic treatment of any disease or the measures to improve health according to any particular method or modality;
- Transplantation: According to Section 2(p), “transplantation” means the grafting of any human organ from any living person or deceased person to some other living person for therapeutic purposes;
Brain-Stem Death:
Brain stem is the “stalk of the brain” which connects the spinal cord to various parts of the brain. It sends messages to the rest of your body to regulate balance, breathing, heart rate and more. It is very vital part of the body. Section 2(d) of the Transplantation of Human Organs and Tissues Act, 1994, defines brainstem death as ““brain-stem death” means the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified under sub-section (6) of section 3 of the Act.”
Identification of brain stem death carries important prognosis for the survival of the patient, because the heart may keep on beating for few days after brain stem death, or even for weeks if the patient is in the Intensive Care Unit of hospital with all forms of medical and cardiac support. The person cannot perform fundamental work of an organism. The person is practically dead but may have heart beat and such person may still able to breathe. Such brain stem death must be certified by a Board of Medical Expert referred to in Section 3(6) of the Act. The Board should contain
- the 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 specified in clause (i), from the panel of names approved by the Appropriate Authority;
- a neurologist or a neurosurgeon to be nominated by the registered medical practitioner specified in clause (i), from the panel of names approved by the Appropriate Authority: Provided that where a neurologist or a neurosurgeon is not available, the registered medical practitioner may nominate an independent registered medical practitioner, being a surgeon or a physician and an anaesthetist or intensivist subject to the condition that they are not members of the transplantation team for the concerned recipient and to such conditions as may be prescribed;
- the registered medical practitioner treating the person whose brain-stem death has occurred
Organ Donor:
Organ donation is basically giving or gifting organ in order to help someone who needs organ transplant to be operated, it could be near relative or any other person. the Transplantation of Human Organs and Tissues Act strictly prohibits commercial dealing in organs of any sort. Generally, in case of organs: heart, kidneys, liver, lungs, intestine, pancreas and tissues being, skin, bones, blood vessels, heart valves, corona, ear drums can be donated for the therapeutic purpose.
According to Section 2(f), “donor” means any person, not less than eighteen years of age, who voluntarily authorises the removal of any of his human organs for therapeutic purposes under sub-section (1) or sub-section (2) of section 3 of the Act”. Under the virtue of Section 3 of the Act, Donor would fall under the following two categories;
- Living Donor: any person not less than 18 years of age, who voluntarily authorizes the removal of any of his organ and/or tissue, during his or her lifetime solely for therapeutic purposes.
- Deceased Donor: Anyone, regardless of age, race or gender can become a donor of any organ and/or tissue after his/her death (Brainstem/Cardiac). A person who is in lawful possession of the dead body or the free consent of ‘near relative is required for the said purpose. If the deceased donor is under the age of 18 years, then the consent required from one of the parents or any near relative authorized by the parents is necessary.
Under section 2(i) of the Act, ‘near-relative’ means spouse, children, grandchildren, brother-sister, parents and grandparents of the patient can donate the organ after taking prior permission from the doctor in-charge of the transplant center to donate his organ. A non-related donor needs prior permission of Authorization Committee established by the state under the Act in order to donate his organs.
In case of living person the age of donor should not be less than 18 years, and in case of tissues, age usually does not matter and generally depends upon the physical structure of the body of person. The cost of donor management, retrieval, transportation and preservation is to be borne by the recipient/ institution/ government/ NGO or society, and not by the donor’s family.
Authorization of Removal of Human Organs or Tissues:
- Under Section3(1) of the Transplantation of Human Organs and Tissues (TOHO) Act, 1994 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 or tissue or both of his body for therapeutic purposes.
- The donor may be any person defined under Section 2(f) of the Transplantation of Human Organs and Tissues (TOHO) Act, 1994 or a person who has given an unequivocal written authorization in presence of two or more witnesses, at least one of whom should be a near relative, for the removal of any human organ or tissue or both of his body after his death for therapeutic purposes.
- The use of the phrase “for therapeutic purposes” means the systematic treatment of any disease or the measures to improve health according to any particular method or modality.
Restrictions on Removal of Human Organs and Tissues:
Section 9 of the Act deals with the restrictions on removal of human organs and tissues.
- No human organ or tissue or both 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 the donor or the recipient being near relative is a foreign national, prior approval of the Authorization Committee shall be required before removing or transplanting human organ or tissue or both. Without such prior approval no human organ or tissue or both can be removed from the body of a donor.
- No human organs or tissues or both shall be removed from the body of a minor before his death for the purpose of transplantation except in the manner as may be prescribed.
- No human organs or tissues or both shall be removed from the body of a mentally challenge person before his death for the purpose of transplantation.
- Where any donor authorizes the removal of any of his human organs or tissues or both after his death under sub-section (2) of section 3 or any person competent or empowered to give authority for the removal of any human organ or tissue or both] from the body of any deceased person authorizes such removal, the 1 [human organ or tissue or both may be removed and transplanted into the body of any recipient who may be in need of such human organ or tissue or both].
- If any donor authorizes the removal of any of his human organs or tissues or both before his death under sub-section (1) of section 3 for transplantation 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 or tissue or both shall not be removed and transplanted without the prior approval of the Authorization Committee.
Appropriate Authority under the Transplantation of Human Organs and Tissues (TOHO) Act, 1994:
The Central Government is empowered by the Act to appoint, by notification one or more officers as the Appropriate Authority for the purposes of the Act, for each of Union Territories. Likewise, every State must by notification, appoint one or more persons as the Appropriate Authority of that State.
Functions of Appropriate Authority:
Section 13 of the Act gives functions of the Appropriate Authority under the TOHO Act, 1994.
- to grant registration under sub-section (1) of section 15 or renew registration under sub-section (3) of that section;
- to suspend or cancel registration under sub-section (2) of section 16;
- to enforce such standards, as may be prescribed,— (A) for hospitals engaged in the removal, storage or transplantation of any human organ: (B) for Tissue Banks engaged in recovery, screening, testing, processing, storage and distribution of tissues;
- to investigate any complaint of breach of any of the provisions of this Act or any of the rules made thereunder and take appropriate action;
- to inspect Tissue Banks periodically;
- 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
- to undertake such other measures as may be prescribed
Punishment for Commercial Dealing of Human Organs:
Commercial dealing of human organs is strictly prohibited under this Act. Any sort or any kind of commercial dealings in human organ would lead to punishment under this Act.
Under Section 19 of The Transplantation of Human Organs Act, 1994, In case of commercial dealings of any kind in human organs, the punishment has been mentioned as under:
The person found doing so shall be punishable with imprisonment for a term, which shall not be less than 2 years but which may extend to 7 years and shall be liable to fine, which shall not be less than ten thousand rupees but may extend to twenty thousand rupees.
Where any offence punishable under this Act has been committed by a company, every person who, at the time the offence was committed was in charge of, and was responsible to, the company for the conduct of the business of the company, as well as the company, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly.