The Foreign Trade (Development and Regulation) Amendment Bill, 2009March 31, 2010
In India, the availability of medical transplants is lower than the requirement. For example, an estimated 1.5 lakh people are diagnosed with kidney failure every year while about 2,000 to 4,000 transplants are carried out every year.2 Also, most donations occur in a few states such as Tamil Nadu, Andhra Pradesh, Gujarat, Maharashtra and Delhi.3
The Transplantation of Human Organs Act, 1994 regulates the removal, storage and transplantation of human organs for therapeutic purposes and prohibits commercial trade in human organs. The Act was initiated at the request of Maharashtra, Himachal Pradesh and Goa and was subsequently adopted by all states except Andhra Pradesh and Jammu and Kashmir, which enacted their own laws.4
Despite a regulatory framework, cases of commercial dealings in human organs were reported in the media.5 In 2004, the Delhi High Court issued orders to constitute a committee to review the efficacy, relevance and impact of the legal provisions contained in the 1994 Act.6 The committee submitted its report on May 25, 2005.7
Taking into consideration this report and the Draft Guiding Principles of Organ Transplantation of the World Health Organisation, the Transplantation of Human Organs (Amendment) Bill, 2009 was introduced.
The Bill shall be applicable to Goa, Himachal Pradesh and West Bengal and all the Union Territories. Other states may adopt the amendment by passing a resolution in the state legislatures.
|Transplantation of Human Organs Act, 1994||Transplantation of Human Organs (Amendment) Bill, 2009|
|Scope||Regulates removal, storage and transplantation of human organs.||Regulates removal, storage and transplantation of human organs and tissues.|
|Definition||“Near relative” means spouse, son, daughter, father, mother, brother, sister.||Adds grandparents and grandchildren.|
|“Tissue” and “Transplant Coordinator” not defined.||
“Tissue” means a group of cells except blood performing a particular function in the human body.
“Transplant coordinator” means a person of the hospital appointed for coordinating matters related to transplantation.
|Removal of organs from deceased person||A donor may authorise removal of organs before his death for therapeutic purposes. If no such authorisation was given but no objection was expressed, the person who has legal possession of the body may authorise such removal unless he believes the near relatives of the deceased may object.||Adds the provision that a doctor shall ask the patient or relative of every person admitted to the ICU whether any prior authorisation had been made. If not, the patient or his near relative should be made aware of the option to authorise such donation.|
|Brain stem death has to be certified by a board of medical experts consisting of various medical experts.||Adds that if a neurologist or neurosurgeon is not available to be on the board, the doctor in-charge of the hospital may nominate an independent doctor who is a surgeon or a physician and an anaesthetist or intensivist not on the transplant team.|
|Live donation||The central government has the power to constitute Authorisation Committees for Union Territories.||Authorisation Committees shall be constituted by the state governments and Union Territories. Their composition shall be prescribed by the central government.|
|A near relative is permitted to donate his organ without approval of the Authorisation Committee. Any live donation to a non near-relative for reason of affection needs the approval of the Authorisation Committee.||
Adds that if the donor or recipient is a foreign national, prior approval of the Authorisation Committee is required.
Prohibits removal of organs or tissues from a minor before his death except in a manner to be prescribed.
|Organ swapping||No provision||A pair of donor and recipient who are near relatives but whose organs do not medically match for transplantation are permitted to swap with another pair of such persons. The agreement between the two sets has to be approved by the Authorisation Committee.|
|Powers of Appropriate Authority||The central and state governments shall appoint appropriate authorities in the Union Territories and states to grant or cancel registration of hospitals, enforce standards for these hospitals, investigate complaints of violations and inspect hospitals.||Adds the provision that appropriate authorities shall have the powers of the civil court for summoning any person, producing documents and issuing search warrants.|
|Advisory Committee||No provision||The central and state governments shall provide for constitution of Advisory Committee for a period of two years to aid and advise the appropriate authority.|
|Other provisions||No provision||
The central govt may establish a National Human Organs and Tissues Removal and Storage Network at any place. Rs 5 crore has been allocated in the Financial Memorandum.
The central government shall maintain a registry of the donors and recipients of human organs and tissues.
|No provision||Non-governmental organisations, registered societies and trusts working in the field of organ or tissue removal, storage or transplantation shall apply for registration in the prescribed manner.|
Penalty for removal of organ without authority is imprisonment for a maximum of five years and a fine of upto Rs 10,000. Penalty for making or receiving payment for supplying human organs is imprisonment for 2-7 years and a fine between Rs 10,000 and 20,000.
Penalty for contravening any other provisions is imprisonment for a maximum term of 3 years or with fine of upto Rs 5,000.
Increases penalty to imprisonment for a maximum of ten years and a fine of upto Rs 5 lakh.
Increases penalty to imprisonment for 5-10 years and a fine between Rs 5 and 20 lakh. Adds offence of abetting in submission of false documents to prove that donor is a near relative or donating for affection.
Increases penalty to imprisonment for a maximum of 5 years or with fine of upto Rs 5 lakh.
The key objectives of the 1994 Act are to facilitate organ transplantation of needy patients while preventing commercial exploitation of vulnerable people. The Statement of Objects and Reasons of the 2009 Bill states that despite the regulatory framework put in place by the 1994 Act, “there has been a spate of reports in the print and electronic media about thriving human organ trade in India and the consequential exploitation of economically weaker sections of the society.” Furthermore, the conviction rate under the Act is very poor.
Also, the World Health Organisation has expressed fears that shortage of organs may lead to commercial transactions, and has laid down some guiding principles. These include a ban on commercial transactions, and a recommendation that the donor be genetically related to the recipient (except in some cases such as bone marrow transplant).9 On the other hand, there is a school of thought that argues against banning commercial trade in face of acute shortage claiming that it only drives the trade underground. They argue in favour of regulated trade with provision for screening, counselling, reliable payment and financial advice.
Since the 1994 Act was not able to curb commercial trade, the Bill seeks to achieve this objective while facilitating genuine cases of organ donation. The amendments in the Bill include enhancing penalties for commercial trade, allowing organ swapping and making it mandatory for a doctor in the ICU to ask every patient or his near relative if he is willing to donate his body in case of death. It is not clear if these measures adequately address the factors that lead to commercialization and low levels of conviction.
The Rules under the 1994 Act state that it is the responsibility of the doctor (in-charge of transplant centre) to ascertain whether a donor is a “near relative” of the recipient. A Review Committee set up to review the Transplantation of Human Organs Act pointed out that there were several instances where the donors were projected to be “near relative” in order to avoid scrutiny. Therefore, the Review Committee recommended that instead of placing the responsibility of certifying a donor as “near relative” on a doctor, the Authorisation Committees should certify a “near relative” keeping in mind the larger objective of ruling out commercial considerations. This recommendation has not been implemented in the Bill.
Some of the other recommendations of the Review Committee to curb trade and increase donations are not included in the Bill: (a) incentives should be given to family of cadaver donor; (b) live donors should get benefits such as life long follow up care where donation took place, and customised Life Insurance Policy; and (c) constitute a fund to promote cadaver organ donation.
The Bill increases the penalty for commercial dealings in human organs. The penalty provision in the Act is applicable to both donors and recipients if they are convicted of commercial trade. It is not clear if increasing penalty provision would curb commercial dealings given the low rate of conviction. Also, having penalty for donors who may be forced to sell organs due to financial need may deter them from complaining against commercial trade.
All organ donations between non-relatives require the permission of the Authorisation Committee established by the state government. It is not clear in the Bill which State Authorisation Committee shall have jurisdiction under certain circumstances. These include (a) the donor and recipient may belong to different states; or (b) one or both of them hail from states which do not have an Authorisation Committee. It is also unclear whether the Authorisation Committee of the state where transplantation is taking place shall retain some jurisdiction (for medical evidence) in case the donor and the recipient belong to other states.
There have been disputes over the jurisdiction of Authorisation Committees. For example, in 2005, a petition was filed in the Supreme Court where both the donor and the recipient belonged to Punjab while the hospital where the transplant was to take place was located in Tamil Nadu. The Supreme Court gave a judgement directing that the Authorisation Committee of Punjab shall examine the donor and the recipient.
The Bill provides for establishment of Advisory Committees to aid and advise the Appropriate Authority. However, the Bill does not lay down the specific functions of the Advisory Committee nor does it state that the functions shall be laid down in the Rules. The Ministry of Health and Family Welfare mentions in its “Note on Amendments Proposed in the Transplantation of Human Organs Act, 1994” that the Advisory Committee shall “function on a reference to be made by the Appropriate Authority and payment of remuneration shall be on per sitting basis.”2 However, the Bill does not specify this provision.
The Advisory Committee will be appointed for a period of two years. It is not clear who would perform this role after this period.
Hospitals may register under the Act to remove, store and transplant organs. The Bill makes it mandatory for medical practitioners in all hospitals (regardless of whether they have this registration) to ask all patients in an ICU or their relative whether the patient wants to donate organs.
If a patient in the ICU or his relative agrees to donate his organs or tissues on his death, the Bill requires the medical practitioner to inform the hospital which in turn has to inform the “Human Organ Removal Centre” for removal, storage and transplantation of human organs or tissues. However, the Bill does not define or specify the composition or functions of the “Human Organ Removal Centre”. Also, the Bill states that Rules shall specify only the manner of informing the “Human Organ Removal Centre”.
The laws in different countries differ in three broad ways: (a) type of consent necessary to transplant organs if a person is dead; (b) type of donors; and (c) whether commercial sale is permitted. Table 2 describes the system and the law in some countries.
|Law||Regulatory Framework||Deceased donors|
|Transplantation of Human Organs Act, 1994||
Type of consent: Opting in/family consent*
Type of donor: Live donation from “near relatives” and un-related donors; Cadaver donor (brain stem death and cardiac death or non heart beating donor); Prohibits sale of human organs.
|National Organ Transplantation Act, 1984||
Uniform Anatomical Gift Act, 1967
Type of Consent: Opting in/ family consent
Type of donor: Live donation through organ swapping; Cadaver donor: (brain death and cardiac death); Prohibits sale of human organs
|26.2 (per million of population or pmp)|
|The Human Tissues Act, 2004 (repeals Human Organ Transplantation Act, 1989 and Anatomy Act, 1984)||
Type of Consent: Opting in/ family consent or nominated representative
Type of donor: Live donation from genetically or emotionally related donors. Also from paired and altruistic donations. Cadaver donation from brain stem death and non heart beating donors.
Prohibits sale of human organs.
|Transplantation Law 1979 and Royal Decree updating law 1999||
Type of Consent: Opting out/ Presumed consent†
Type of donor: Live donation with voluntary consent from relatives or emotionally related donors. Allows organ swapping. Cadaver donation
Prohibits sale of human organs.
|Austrian Hospitals Law 1982||
Type of Consent: Opting out/ Presumed consent
Type of donor: Allows donation from brain dead cadaver donors, non-heart beating cadaver donors and living donors.
Prohibits sale of human organs.
|The Transplantation of Human Organs and Tissues Act, 2009||
Type of Consent: Opting in/consent of family Type of donor: Live donations from close blood relative and non-close blood relative. Cadaver donations of brain dead patients.
Prohibits sale of human organs.
|Human Organ Transplant Act, 2009 (HOTA) and Medical (Therapy, Education and Research) Act||
Type of Consent: Opt out for 4 organs (kidney, liver, heart and cornea); Opt in for any organ or tissue not covered by HOTA. Both donor and his next of kin can pledge organ.
Type of donor: Live donations (related and non-related). Cadaver donation (brain death and cardiac death). Prohibits sale of human organs.
|Organ Transplantation and Brain Death Act, 2000||
Type of Consent: Opting in/consent from family
Type of donor: Cadaver donation (brain death and cardiac death)
Live donation (regulated paid donor system or a monetary gift as a “token of appreciation” by central govt )
Sources: The National Organ Transplantation Act, 2008 and The Revised Uniform Anatomical Gift Act, 2006 (USA); Human Tissues Act, 2004 (U.K.); European Transplant Coordinators Organisation (See pdf) (Spain); “Consent System for Post Mortem Organ Donation in Europe,” Sjef Gevers, Anke Janssen & Roland Friele, European Journal of Health Law, 2004, vol 11, pp 175-186 (Austria); The Transplantation of Human Organs and Tissues Act, 2009 (Pakistan); Human Organ Transplant Act, 2009 and Medical (therapy, Education and Research) Act (see http://www.moh.gov.sg/content/moh_web/home.html ) (Singapore); “Living unrelated kidney donor transplantation in Iran,” Ali Nobakht Haghighi and Nasrollah Ghahramani, Nature Clinical Practice Nephrology, 2006, vol 2, no. 12 (Iran), International Registry of Organ Donation and Transplantation (IRODaT), 2008.
Consent of patient or family is necessary to remove organs once the patient is dead.
Consent of patient to donate organs on his death is presumed unless he has specifically opted out.