79. Transplantation of human organs

Transplantation of human organs is governed by Transplantation of Human Organs Act, 1994 (herein after referred as 'Act') read with Transplantation of Human Organs Rules, 1995 (herein after referred as 'Rules').The Act was promulgated 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.

The Act has came into force w.e.f. 4-2-1995 in certain States and in all Union Territories. It is provided in Section 1 of the Act that it shall apply to such other States which adopt the Act by resolution passed in that behalf under clause (1) of Article 252 of the Constitution.

Section 9 deals with "Restriction on removal and transplantation of human organs". The same reads as follows :

"Restrictions on removal and transplantation of human organs-

(1) Save as otherwise provided in sub-section (3), 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.

(2) Where any donor authorizes the removal of any of his human organs 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 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.

(3) If any donor authorizes the removal of any of his human organs 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 shall not be removed and transplanted without the prior approval of the Authorisation Committee.

(4) (a) The central Government shall constitute, by notification, one or more Authorisation Committees consisting of such members as may by 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 of this section.

(b) The State Government shall constitute, by notification, one or more Authorisation Committees consisting of such members as may be nominated by the State Government on such terms and conditions as may be specified in the notification for the purposes of this section.

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 thereunder, 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 thereunder, it shall, for reasons to be recorded in writing, reject the application for approval."

The provision refers to donors who are not "near relatives" of the recipient. The expression 'near relatives' is defined in Section 2(i) to mean 'spouse, son, daughter, father, mother, brother or sister'. Chapter II deals with "Authority for the removal of human organs". Sub-section (2) of Section 3 deals with removal of the organs after death for thereapeutic purposes. Sub-section (1), however, deals with authorization by any donor for removal of any human organ before his death for therapeutic purposes. Sub-section (4) of Section 9 deals with constitution of Authorisation Committee consisting of such members as may be notified by the Central Government or the State Government, as the case may be. Under sub-section (5) of Section 9 application is required to be jointly made by the donor and the recipient in the prescribed manner. The Authorisation Committee is required to hold an enquiry and if after such an enquiry it is certified that the applicants have complied with the requirements of the Act and the Rules, it can grant the applicant's approval for the removal and transplantation of the concerned human organs. If on the contrary, after enquiry and after giving an opportunity to the applicants of being heard, the Authorisation Committee is of the view that the applicants have not complied with the rquirements of the Act and the Rules, the application for approval may be rejected for reasons to be recorded in writing. Section 11 prohibits removal or transplantation of human organs for any purpose other than therapeutic purposes. Chapter VI deals with "Offences and Penalties". Section 18 provides for removal of human organ without authority. Section 19 provides for punishment for commercial dealings in human organs. The shocking exploitation of abject poverty of many donors for even small sums of money, appears to have provided the foundation for enacting the Act. The Authorisation Committee has to be satisfied that the authorization for removal is not for commercial consideration. Since some amount of urgency has to be exhibited because of the need for transplantation, expeditious disposal of the application would be appropriate. But the matter should not be dealt with in a casual manner as otherwise the intent and purpose of the Act shall be frustrated.

Rule 3 deals with "Authority for Removal of Human Organ". The conditions for removal before death are incorporated in the Form I. The same reads as follows :

"Authority for Removal of Human Organ-

Any donor may authorize the removal, before his death, of any human organ of his body for therapeutic purposes in the manner and on such conditions as specified in Form I."

Form I reads as follows :

"I, --- aged -----s/o, d/o, w/o, Mr. ---------- resident of ------- hereby authorize to remove for therapeutic purposes/ consent to donate my organ, namely, ----------- to:

(i) Mr./Mrs. --------- s/o, d/o, w/o Mr.---------- aged ---- resident of ----- who happens to be my near relative as defined in clause (i) of Section 2 of the Act.

(ii) Mr. /Mrs. --------s/o, d/o, w/o Mr.------------- aged ---- resident of -------- towards whom I possess special affection or attachment, or for any special reason (to be specified)

I certify that the above authority/consent has been given by me out of my own free will without any undue pressure, inducement, influence or allurement and that the purposes of the above authority/donation and of all possible complications, side-effects, consequences and options have been explained to me before giving this authority or consent or both.

Signature of the Donor"

Where the donor is not "near relative" as defined under the Act, the situation is covered by sub-section (3) of Section 9. As the Form I in terms of Rule 3 itself shows the same has to be filed in both the cases where the donor is a near relative and where he is not, so far as the recipient is concerned. In case the donor is not a near relative the requirement is that he must establish that removal of the organ was being authorized for transplantation into the body of the recipient because of affection or attachment or for any special reasons to make donation of his organ. As the purpose of enactment of the Statute itself shows, there cannot be any commercial element involved in the donation. The object of the Statute is crystal clear that it intends to prevent commercial dealings in human organs. The Authorization Committee is, therefore, required to satisfy that the real purpose of the donor authorizing removal of the organ is by reason of affection or attachment towards the recipient or for any other special reason. Such special reasons can by no stretch of imagination encompass commercial elements. Above being the intent, the inevitable conclusion is that the Authorization Committees of the State to which the donor and the donee belong have to take the exercise to find out whether approval is to be accorded. Such Committee shall be in a better position to ascertain the true intent and the purpose for the authorization to remove the organ and whether any commercial element is involved or not. They would be in a better position to lift the veil of projected affection or attachment and the so-called special reasons and focus on the true intent. The burden is on the applicants to establish the real intent by placing relevant materials for consideration of the Authorization Committee. Whether there exists any affection or attachment or special reason is within the special knowledge of the applicants, and a heavy burden lies on them to establish it. Several relevant factors like relationship if any (need not be near relationship for which different considerations have been provided for), period of acquaintance, degree of association, reciprocity of feelings, gratitude and similar human factors and bonds can throw light on the issue. It is always open to the Authorization Committee considering the application to seek information/materials from Authorization Committees of other States/State Governments, as the case may be, for effective decision in the matter. In case any State is not covered by the operation of the Act or the Rules, the operative executive instructions/Government orders will hold the field. As the object is to find out the true intent behind the donor's willingness to donate the organ, it would not be in line with the legislative intent to require the Authorization Committee of the State where the recipient is undergoing medical treatment to decide the issue whether approval is to be accorded. Form I in terms requires the applicants to indicate the residential details. This indication is required to prima facie determine as to which is the appropriate Authorization Committee. In the instant case, therefore, it was the Authorization Committee of the State of Punjab which is required to examine the claim of the petitioners.

It is notable here that there is a provision for appeal in terms of Section 17 of the Act in case of refusal by the Authorization Committee. But taking into account the urgency involved and the grey area projected by the two States regarding the proper Authorization Committee, we have entertained the Writ Petition and decided the issues involved. In the normal course, it would be for the Appellate Authority constituted in terms of Section 17 who has to consider the appeal to be preferred by the aggrieved party.

With aforesaid discussions the supreme court in Kuldeep singh v. State of T.N., AIR 2005 SC 2106 directed for certain amendments in following terms:

“Since the object of the Statute is to rule out commercial dealings, it would be desirable to require the donor and recipient to give details of their financial positions and vocations. It would be appropriate for the Legislature to accordingly amend the Rules and the Form I, so that requirement for disclosing incomes and vocations for some previous financial years (say 3 years) gets statutorily incorporated. This would help the Authorization Committees to assess whether any commercial dealing is involved or not. Until legislative steps are taken, all Authorization Committees shall, in terms of this judgment require the applicants to furnish their income particulars for the previous three financial years and the vocations.”