The Union Parliament had enacted the Transplantation of Human Organs Act (THOA) in 1994 and the Act came into force in February, 1995. The main purpose of the Act is to regulate the removal, storage and transplantation of human organs for therapeutic purposes and to prevent commercial dealings in human organs. Despite having put into place a regulatory mechanism for transplantation of human organs, there is a wide disparity between demand and supply of organs in India. There has, therefore, been an increasing perception in civil society that while the Act has not been effective in curbing commercial transactions in organ transplant, it has thwarted genuine cases due to the complicated and long drawn process involving organ donation.

The Hon’ble High Court of Delhi had in September, 2004 constituted a Review Committee to examine various provisions of the Act and the Rules made there under. Based on the feedback received, this Ministry has drafted the Transplantation of Human Organs and Tissues (Amendment) Bill, 2008. Given below are excerpts from the amendments proposed in the Bill:

THE ACT TO COVER BOTH ORGANS & TISSUES

Currently, the Act deals only with human organs. During the national consultation, a view had emerged that with advancement in medical technology, apart from human organs, even tissues and cells were being transplanted. Accordingly, it is proposed to amend the THO Act by changing its name from ‘Transplantation of Human Organs Act’ to ‘Transplantation of Human Organs & Tissues Act.’

EXPANSION OF THE TERM “NEAR RELATIVES”

The Act currently defines the term “near relative” to mean spouse, son, daughter, father, mother, brother or sister. It is proposed to modify the definition of ‘near relative’ in Section 2, only to the extent of including grandparents and grandchildren. All other cases of donation even from donors related by blood to the recipient would necessarily be routed through the Authorization Committee.

REQUIRED REQUEST

It is recommended that every hospital should make it mandatory for the ICU/ Treating Medical Staff to request relatives of brain dead patients for organ donation. A record of all brain dead patients and that of the next of kin who are approached should be kept. It is proposed in the fi rst instance to introduce this requirement of required request in the case of corneas.

SPECIAL PROVISION FOR REMOVAL OF CORNEAS

The THO Act in section 3, currently provides that organs shall be removed by a registered medical practitioner only. This stipulation was actually hampering the eye donation programme as it is generally difficult to keep an eye surgeon available for the removal of corneas. It was, therefore, suggested that for the removal of corneas, a trained eye technician could easily do the job. This suggestion has been accepted and it is proposed that in Section 3, after sub section (4), a new sub section 4-A shall be inserted to provide that a technician possessing such qualifications and experience as may be prescribed, may enucleate a cornea.

CERTIFICATION OF BRAIN DEATH

In the case of removal of organs from a person who has been declared as brain dead, subsection 6 provides for a medical board to certify such death. This board is to comprise among others a neurosurgeon and a neurologist. The Review Committee had suggested that due to the shortage of neurosurgeons and neurologists brain death certification had not taken off in the country. It has, therefore, been recommended that in the event of the non availability of a neurosurgeon/ neurologist, a surgeon/ physician and an anesthetist/ intensivist could be nominated from a panel already approved by the Appropriate Authority. Such surgeons/physicians, anaesthetist / intensivist shall, however, not associate with the removal of the organs from the donors or its transplantation into the recipients in any time before the members of the transplant team arrive. The recommendation is proposed to be given effect to by introducing a new sub  clause (a) after sub-section (6)(iii) of Section 3.

FOREIGN NATIONALS

There have been reports often carried by the media that India is heading towards becoming the hub of transplant tourism.  To protect our vulnerable sections of society from exploitation through organ trade it is proposed  to introduce two new provisions in the Act.

i) Inserting in Section 9 a new sub section 3-A to prohibit grant of permission by the authorization committee for organ transplantation where the recipient is a foreign national and the donor is an Indian national.

ii) Inserting in Section 9 a new subsection 1-A to provide that where the donor and/ or the recipient being near relatives are foreign nationals prior approval of the authorization committee would be required before removing and/ or transplanting organs in all such cases. As the law stands today, cases of near relatives are not required to be processed through the Authorisation Committees.

MINORS

Guiding Principle of the WHO, on Transplantation of Human Organs inter-alia provides, “No cells, tissues or organs should be removed from the body of a living minor for the purpose of 9transplantation other than narrow exceptions allowed under national law. Specific measures should be in place to protect the minor and, wherever possible the minor’s assent should be obtained before donation. What is applicable to minors also applies to any legally incompetent person.” It is proposed to give effect to this guiding principle by inserting a new section 17 C in the Act to provide that no human organs or tissues should be removed from the body of a living minor for the purpose of transplantation other than narrow exceptions as may be prescribed. The major exceptions that may be authorized are familial donation of regenerative cells (when a therapeutically comparable adult donor is not available) and kidney transplants between identical twins (where avoiding immunosuppression represents a benefit to the recipient adequate to justify the exception, in the absence of a genetic disorder that could adversely affect the donor in the future).

SWAP DONATIONS

Currently, the law permits donation of an organ by an individual, who falls in the category of near relative of the recipient without going through the Authorization Committee as indicated above. All other cases have to be routed through the Authorization Committee. It is now recommended that swap donations be allowed. The Committee has recommended that two diff erent willing but incompatible ‘near relative’ donors (vis-à-vis their intended related recipient) should be permitted to donate their organs in exchange without any commercial interest and only due to the reason that despite willingness, their organ was not found medically compatible for their intended recipients. This would greatly help patients who have ‘near relatives’ willing to donate but incompatible for their recipient. Swap operations may be considered by authorization committee on case-to-case basis and as per the existing THO Act and Rules. This recommendation has been accepted by the Ministry and an amendment is proposed to be made in section 9 by inserting a new subsection 3(a) to allow a swap donation.

TRANSPLANT COORDINATORS

 The Review Committee has recommended that hospitals/ centres in transplantation activity be advised to have a post of a coordinator in the ICU (who may be a doctor or a senior nursing staff member) independent of the Transplant team, who is trained in the communications skills and who can liaison between the treating physician and the potential brain-death donor and ORBO. Such coordinators should possess skills to communicate with the relatives and friends of the patient with a view to explain to them the merits of cadaver donation and who possesses adequate knowledge to remove their doubts and answer their queries with regard to the procedures involved in transplantation activities. Donor transplant coordinators are generally responsible for the care of the person who has died, speaking to their family and organising the organ donation procedure. They support families before, during and after donation and are there to answer any questions they might have. Part of their role is to ensure that the donor’s family is told in general terms about the eventual use of the donated organs. Recipient transplant coordinators help to assess patients’ suitability to go on the transplant waiting list and organise the transplant operation as well as follow-up consultations for those patients who have been lucky enough to receive a donated organ. Some coordinators work with both recipients and donor families. It is, therefore, proposed to define the term ‘transplant coordinator’ by inserting a new clause (s) in Section 2. Further, to provide that no hospital shall be registered under this Act, unless the appropriate authority is satisfied that such hospital has created the position of a Transplant Coordinator with such qualifications and experience as may be prescribed in the Rules and has also appointed the Transplant Coordinator accordingly, a new sub-section (4) shall be inserted after sub-section 3 in Section.

POWERS OF THE APPROPRIATE AUTHORITY

The Act provides for an ‘Appropriate Authority’ to be set up in each State/ Union Territory to perform the following functions:-

(i) To grant registration to a hospital for the removal, storage and transplantation of any human organ.

(ii) To suspend or cancel such registration.

(iii) To enforce standards for hospitals engaged in the removal/ storage or transplantation of human organs.

(iv)To investigate any complaint or breach of any provision of the Act or the rules made thereunder.

(v) To inspect hospitals periodically for examination of the quality of transplantation and follow up medical care to the recipients as well as donors. Such appropriate authorities are constituted by the Central Government in the case of Union Territories and by the State Government in the case of States. These are generally single member bodies comprising of Secretary (Health) or the Director of Health Services of the State Government concerned. In the case of Union Territories, Director General of Health Services, Government of India has been notified as the ‘appropriate authority’.

To improve the effectiveness of Appropriate Authorities, it is proposed to vest in them the powers to summon any person, seek production of a document and issue a warrant for the search of any place suspected to be indulging in unauthorized transactions in human organs. A new section 16 A is proposed to be introduced accordingly.

Setting up of an Advisory Committee for aiding and assisting Appropriate Authority in the discharge of its functions

It has often been said that the poor conviction rate under the Act is mainly due to the fact that the officer of the Department of Health, who is designated as the appropriate authority in most States takes on this responsibility in addition to other administrative functions. He/ she is unable to find time for a methodical and systematic discharge of the duties assigned to the Appropriate Authority under the Act. In view of the above, it is proposed to provide for the setting up of an Advisory Committee for the Appropriate Authority by inserting a new section 16 B. 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.

Authorisation Committees

The Review Committee has observed that in metropolitan cities, for diff erent hospitals providing facilities of transplantation surgery, there are distinct and independent Authorisation Committees. This practice of hospital-based Authorisation Committees is workable and practical in metropolitan cities and the state capitals where large distances need to be travelled and it may not be possible for the medical practitioners and other members of the committee to leave hospital and go to another place for attending the meeting. The increasing vehicular traffi c in such cities restricts mobility. But, in non-metropolitan cities and smaller capital cities of states, a single Authorisation Committee for the entire district or a Division comprising several Districts, depending upon the factors like size of population; number of transplantation centers available within the territory and other administrative exigencies, would serve the purpose.

Suitable modifi cations have been proposed in the rules in sub section 4 of Section 9:

(a) Vesting in the Central Government the power to prescribe the composition of the Authorisation Committees though the actual appointments would be made by the concerned State Governments. Presently, this power is vested in the Central Government only in respect of Union Territories. It is considered desirable to have uniformity in the composition of the Authorisation Committees. There would, therefore, be consequential changes in Section 9 of the Act.

(b) Currently, the Central Government appoints the Authorisation Committees for Union Territories. It is proposed that this power be delegated to the respective Union Territories.

National Registry

The Central Government shall provide for the development and maintenance of a scientifi c registry of the recipients of organ transplants. The registry shall include such information in respect of patients and transplant procedures as the Central Government may prescribe as necessary to an ongoing evaluation of the scientifi c and clinical status of organ transplantation. A new section 17-A shall be inserted.

National Organ Retrieval, Banking and Transplantation Network

An effi cient network that links organ retrieval and transplant centres to facilitate exchange information about availability of organs and database of recipients holds the key to the success of any transplant programme. Organ Procurement & Transplant Networks have been set up in the USA, UK, Spain and in few other countries as well. While the structure of the networks may vary from country to country, their objectives are generally similar. A similar role had been expected of the Organ Retrieval & Banking Organisation (ORBO) set up at AIIMS in New Delhi. However, experience indicates that ORBO has got largely confi ned to AIIMS and Delhi. Therefore, the need has been felt for the establishment of a nation wide network on the lines of the Organ Procurement and Transplantation Network of USA or UK Transplant of UK. Such a network would include:

a. All transplant centres

b. All retrieval organizations

c. All certifi ed HLA testing labs

d. In future – all trauma centres, all dialysis centres, all hospitals with ICUs The network would maintain a waiting list of patients awaiting transplantation. Diff erentlists would be maintained for diff erent organs. The network would facilitate matching of organs through a computerized database. It would establish a national system, through the use of computers and in accordance with established medical criteria, to match organs and individuals included in the list, especially individuals whose immune system makes it diffi cult for them to receive organs. It is, therefore, proposed that the Central Government shall as soon as it may be possible, provide for the establishment and operation of an Organ Retrieval, Banking and Transplantation Network at one location or through multi-locations and/ or Regional Centres. For this purpose, a new section 17-B shall be introduced.

Review of Penal Provisions

Difficulty in proving that payments have been made for procuring organs

The Review Committee Court has observed that in most of the cases where complaints are made, alleging commercial dealing in organ donation, police investigations cannot lead to any conclusive proof of commercial transaction. At best, the police may be able to gather evidence with regard to impersonation, false documentation or wrong affi davits. But evidence of the allegation that money has exchanged hands is extremely diffi cult to be collected. The factors like impersonation, forgery or swearing false affi davits are already covered as punishable off ences under theIndian Penal Code. Section 19 of THO Act, except for defi ning the nature of activities requiring prosecution has no other substantial role to play. Accordingly, it is recommended that the Central Government may review Section 19 of THO Act. It is also suggested that the THO Act and Rules may be amended to introduce an element of presumption in cases where there has been impersonation and falsifi cation of documents to establish relationship between donor and recipient when none exists. This can at least make law justifi able (eff ective). It is, therefore, proposed to insert a new clause (g) in Section 19 to provide that whoever prepares or abets in the preparation and or submission or whoever, submits false documents including wrong affi davits to establish that the donor is making the donation of an organ as a near relative or out of love and aff ection for the recipient would also be punishable as a person who has offered or received payment for the organs. 

Enhancement of Penalties

The Review Committee has recommended signifi cant enhancements in the penalties for off ences committed under the Act to serve as effective deterrents. It is, therefore, proposed that minimum imprisonment for off ences under the Act should not be less than fi ve years and fi ne would not be less than Rs. five lakhs. The following amendments are therefore to be made:

Section 18: Punishment for removal of human organ without authority

a. In Section 18 sub-section (i), the term “five years” years shall be substituted by the term “ten years” and the term “ten thousand rupees” shall be substituted by term “five lakh rupees.”

b. In sub-section (ii), the term “two years” shall be substituted by the term “three years.”

Section 19: Punishment for commercial dealings in human organs

c. Section 19 – The term “two years” shall be substituted by the term “five years” and the term “seven years” shall be substituted by the term “ten years” and the term “ten thousand rupees” shall be substituted by “five lakh rupees” and the amount “twenty thousand rupees” shall be substituted by “twenty lakh rupees.”

d. The proviso to Section 19 shall be deleted.

Section 20: Punishment for contravention of any other provision of this Act

e. Section 20 – the term “three years” shall be substituted by the term “five years” and the amount of “five thousand rupees” shall be substituted by “five lakh rupees.”

Registration of NGOs

It is also proposed to introduce a provision for the registration of Non Government Organizations that are engaged in transplantation of organs in any manner whatsoever, with the appropriate authority. This is being suggested with a view to be able to monitor the activities of all organizations/ agencies including not for profit bodies that are engaged in or associated with the transplantation of human organs. A new section 17-D is being introduced accordingly.

Power to make rules

It is also proposed to amend Section 24 to expand the rule making power of the Central Government to provide for the following:

(i) the qualification and experience to be possessed by a technician to be eligible for enucleating a cornea.

(ii) the conditions for an anesthetist/ intensivist and surgeon/ physician for being included on the medical board for certification of brain death.

(iii) the qualifications and experience required for the position of transplant coordinator.

(iv) the composition of authorization committees.

(v) conduct of business by the authorization committees.

(vi) narrow exceptions in which transplants from a minor are to be allowed.

(vii) the form and manner in which the National Registry specifi ed is to be maintained.

(viii) the functions to be performed by the National Organs Retrieval Banking and Transplantation Network.

(ix) the registration of NGOs.