Master Siddhant Vikram Pal v. Authorization Committee
2013-06-21
A.R.JOSHI, A.S.OKA
body2013
DigiLaw.ai
Judgment :- A.S. Oka, J. 1. The Transplantation of Human Organs Act 1994 (hereinafter referred to as “the said Act”) was enacted with the specific object of providing for the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs. In view of resolution passed by the legislature of the State of Maharashtra, in pursuance of Clause (1) of Article 252 of the Constitution of India, the said Act came into force in the State of Maharashtra with effect from 4th February 1995. In exercise of powers conferred by Sub-section (1) of Section 24 of the said Act, the Central Government has framed the Transplantation of Human Organs Rules, 1995 (hereinafter referred to as “the said Rules”). The Rules underwent extensive amendment with effect from 4th August 2008. 2. The present Petitions have been filed essentially in view of the delay in disposal of the applications made before the Authorization Committee for grant of approval to the proposal of a donor for removal of kidney before his death for transplantation into the body of a 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. These are the cases of the persons who are suffering from renal failure and who are in need to undergo kidney transplantation. Considering many such Petitions filed in this Court, we requested the learned counsel appearing for some Petitioners Shri U.P. Warunjikar, the learned counsel Shri Nargolkar appearing for the Ruby Hall Clinic as well as the learned Government Pleader to address the Court on the aspects of delay in disposal of the Applications by the Authorization Committee, the procedure to be followed by the Authorization Committee and infrastructure to be made available to the Authorization Committees. All of them have ably assisted the Court. The learned Government Pleader has also made suggestions as regards the basic infrastructure which is required to be made available to the Authorization Committees. 3. We have given careful consideration to the submissions made across the bar. It will be necessary to make a reference to Section 9 of the said Act which reads thus:- “9. Restrictions on removal and transplantation of human organs.
3. We have given careful consideration to the submissions made across the bar. It will be necessary to make a reference to Section 9 of the said Act which reads thus:- “9. 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 of any person competent or empowered to give authority for the removal of any human organ from the body of any deceased person authorises 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 Page 6 of 13 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 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. (5) 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 organs.
(6) 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”. 4. The Sub-section (1) of Section 9 of the said Act provides that 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. In Clause (i) of Section 2 of the said Act, the “near relative” is defined to mean spouse, son, daughter, father, mother, brother or sister. We are not concerned with Sub-section (2) of Section 9 of the said Act which applies where the donor authorizes removal of his human organ after his death. The normal rule provided in Sub-section (1) thereof is that no human organ removed from the body of a donor before his death can be transplanted into a recipient unless the donor is a near relative of a recipient. Sub-section (3) of Section 9 of the said Act carves out an exception to the general rule. Sub-section (3) provides that if a donor authorizes the removal of his human organ before his death for transplantation into the body of a recipient, not being a 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 for transplantation without prior approval of the Authorization Committee. Thus, for the cases covered by Sub-section (3) of Section 9 of the said Act, the removal of human organs for transplantation requires prior approval of the Authorization Committee. The present cases are covered by Sub-section (3) of Section 9 of the said Act and, therefore, we are dealing with only such category of cases. As per Sub-section (4)(a) of Section 9 of the said Act, the State of Maharashtra has exercised the powers and has constituted 67 hospitals based the Authorization Committees at various places in the State. Thus, the Authorization Committees play an important role. 5. Paragraph No.12 of the decision of the Apex Court in the case of Kuldeep Singh and Another v. State of Tamil Nadu and Others [ (2005)11 SCC 122 ] reads thus:- “12.
Thus, the Authorization Committees play an important role. 5. Paragraph No.12 of the decision of the Apex Court in the case of Kuldeep Singh and Another v. State of Tamil Nadu and Others [ (2005)11 SCC 122 ] reads thus:- “12. 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 Authorisation 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 Authorisation 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 authorisation 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 Authorisation 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.
The burden is on the applicants to establish the real intent by placing relevant materials for consideration of the Authorisation 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 Authorisation Committee considering the application to seek information/materials from Authorisation 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 Authorisation 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 Authorisation Committee. In the instant case, therefore, it was the Authorisation Committee of the State of Punjab which is required to examine the claim of the petitioners”. (Underlines added) 6. It will be also necessary to make a reference to the said Rules. The matters on which the Authorization Committee shall focus have been enumerated in Rule 6F of the said Rules. Clause (d) of the Rule 6F of the said Rules reads thus:- “6F. The Authorisation Committee shall focus its attention on the following, namely:- (a) ….......................... (b) ….......................... (c ) …......................... (d) Where the proposed transplant is between individuals who are not “near relatives”, The authorization committee shall evaluate:— (i) that there is no commercial transaction between the recipient and the donor. That no payment of money or moneys worth as referred to in the sections of the Act, has been made to the donor or promised to be made to the donor or any other person.
That no payment of money or moneys worth as referred to in the sections of the Act, has been made to the donor or promised to be made to the donor or any other person. In this connection the Authorisation Committee shall take into consideration:— (a) an explanation of the link between them and the circumstances which led to the offer being made; (b) documentary evidence of the link e.g. proof that they have lived together etc.; (c) reasons why the donor wishes to donate; and (d) old photographs showing the donor and the recipient together. (ii) that there is no middleman/tout involved; (iii) that financial status of the donor and the recipient is probed by asking them to give appropriate evidence of their vocation and income for the previous three financial years. Any gross disparity between the status of the two, must be evaluated in the backdrop of the objective of preventing commercial dealing; (iv) that the donor is not a drug addict or a known person with criminal record; (v) that the next of kin of the proposed unrelated donor is interviewed regarding awareness about his/her intention to donate an organ, the authenticity of the link between the donor and the recipient and the reasons for donation. Any strong views or disagreement or objection of such kin may also be recorded and taken note of”, 7. At this stage, it will be also necessary to make a reference to the Form No.10 which is the prescribed form for application for approval for transplantation (Live Donor) under the said Rules. The said prescribed form incorporates instructions to the Applicant/s to submit documents as under: “1. Form 10 must be submitted along with the completed Form 1 (A), or Form 1 (B) or Form 1 (C) as may be applicable. 2. The applicable Form i.e., Form 1 (A) or Form 1 (B) or Form 1 (C) as the case may be, should be accompanied with all documents mentioned in the applicable form and all relevant queries set out in the applicable form must be adequately answered. 3. Completed Form 3 to be submitted along with the laboratory report. 4. The doctor’s advice recommending transplantation must be enclosed with the application. 5.
3. Completed Form 3 to be submitted along with the laboratory report. 4. The doctor’s advice recommending transplantation must be enclosed with the application. 5. In addition to above, in case the proposed transplant is between unrelated persons, appropriate evidence of vocation and income of the donor as well as the recipient for the last three years must be enclosed with this application. It is clarified that the evidence of income does not necessarily mean the proof of income tax returns, keeping in view that the applicant(s) in a given case may not be filing income tax returns. 6. The application shall be accepted for consideration by the Authorisation Committee only if it is complete in all respects and any omission of the documents or the information required in the forms mentioned above, shall render the application incomplete.” 8. The analysis of the aforesaid provisions shows that before the Authorization Committee grants approval in terms of Sub-section (5) of Section 9 of the said Act, apart from what is laid down by the Apex Court in the case of Kuldeep Singh (supra), the Authorization Committee is required to satisfy itself on the following aspects after holding an inquiry as provided in Sub-section (5) of Section 9 of the said Act. (i) The Authorization Committee must be satisfied about the necessity of a recipient undergoing transplantation. Therefore, there is a provision in Form No.10 which is a part of the said Rules that the doctors' advice recommending transplantation must be enclosed with the Application; (ii) The donor has affection or attachment towards a recipient; (iii) If the case of affection or attachment towards a recipient is not pleaded, whether any other special reasons as contemplated under Sub-section (3) of Section 9 of the said Act exist; Whether the special reasons exist or not will naturally depend upon the facts and circumstances of each case and no hard and fast rule can be laid down in that behalf. In addition, before granting approval, the Authorization Committee must be satisfied on the aspects set out in Sub-clauses (i), (ii) and (iv) of Clause (b) of Rule 6F of the said Rules. 9. The Form No.10 also requires production of appropriate evidence of vocation and income of the donor as well as the recipient for the last three years.
In addition, before granting approval, the Authorization Committee must be satisfied on the aspects set out in Sub-clauses (i), (ii) and (iv) of Clause (b) of Rule 6F of the said Rules. 9. The Form No.10 also requires production of appropriate evidence of vocation and income of the donor as well as the recipient for the last three years. It is clarified that the evidence of income does not necessarily mean the proof of income tax returns as in a given case, a person may not have filed income tax returns. The examination of vocation and income of the donor as well as the recipient is absolutely mandatory. When it is noticed that the financial condition of the donor is not sound as compared to that of recipient, the Authorization Committee must carefully probe into the case with a view to ensure that there is no commercial dealing. 10. The approval as contemplated by Sub-section (5) of Section 9 of the said Act can be granted by the Authorization Committee only after holding an inquiry and after satisfying itself that the Applicants have complied with all requirements of the Act and the Rules thereunder in the light of what we have discussed above. 11. If the approval is granted without proper verification and consideration of relevant factors, the very object of the said Act of preventing the commercial trafficking in human organs may fail. At the same time, the Authorization Committee must bear in mind the need of recipient. 12. Sub-section (5) of Section 9 of the said Act requires the Authorization Committee to record satisfaction that the Applicants have complied with the requirements of the Act and the Rules. For recording satisfaction, the Authorization Committee must be satisfied that the donor has affection or attachment towards the recipient or there exist other special reasons for the donor to agree for donating the human organs to the recipient. For recording the said satisfaction, veracity of the claim made by the donor and the recipient has to be tested. That is one reason why it is necessary to have a separate establishment for each Authorization Committee. The Authorization Committee will have to be provided with the adequate staff. Moreover, it is necessary to make available service of the police machinery to the Authorization Committee to make necessary verification of the documents produced by the donor and the recipient.
That is one reason why it is necessary to have a separate establishment for each Authorization Committee. The Authorization Committee will have to be provided with the adequate staff. Moreover, it is necessary to make available service of the police machinery to the Authorization Committee to make necessary verification of the documents produced by the donor and the recipient. The availability of the services of the police officials to the Authorization Committee is necessary as the inquiry before the Committee will involve making of a field inquiry by visiting the places all over the country. We may state here that for verification of the caste claims by the Caste Scrutiny Committees constituted under the provisions of the Maharashtra Scheduled Castes, Scheduled Tribes, De-notified Tribes (Vimukta Jatis) Nomadic Tribes, Other Backward Classes and Special Backward Category (Regulation of Issuance and Verification of) Caste Certificate Act, 2000, a vigilance cell is available which consists officers of the police. Similarly, the vigilance machinery will have to be made available to the Authorization Committees. The Government Notifications appointing Authorization Committees have been placed on record. We find that in many cases, the Chairpersons of the Authorization Committees are the Deans of the concerned Medical Colleges/hospitals. Thus, an important duty is required to be performed by the Deans in addition to their other responsibilities as the heads of the Government hospitals and Medical Colleges. Therefore, as suggested by the learned Government Pleader, the State Government must provide separate establishments to the Authorization Committees for its efficient and proper working. It is necessary to create the following posts for each working committee. (i) Full Time Secretary; (ii) Full Time Clerks (at least two); (iii) Social Service Superintendent ( Medical) possessing qualification of Master of Social Work. 13. Apart from the staff, the entire infrastructure such as adequate number of computers, printers, internet connections and photocopying machines, shall be made available to the Authorization Committees. The every Authorization Committees shall be provided the assistance of the police machinery for verification of the documents submitted by the Applicants and also for holding the field inquiry, if necessary. The State Government shall make available assistance of designated police personnel attached to the local police station to each Authorization Committee. The Committees have to be made fully functional by filling up all the vacancies and by making appropriate provision for payment of appropriate remuneration/allowances to the member. 14.
The State Government shall make available assistance of designated police personnel attached to the local police station to each Authorization Committee. The Committees have to be made fully functional by filling up all the vacancies and by making appropriate provision for payment of appropriate remuneration/allowances to the member. 14. In some Petitions, we noticed that the Applications under Sub-section (3) of Section 9 of the said Act are being forwarded through the concerned registered hospital where removal and transplantation is to be performed. Such practice is contrary to the said Act and the Rules. The said practice has to be forthwith discontinued and the applications will have to be directly submitted to the concerned Authorization Committees. As far as the powers of the Authorization Committees are concerned, we have already referred to the Rule 6F and in particular Clause (d) thereof. Therefore, the Authorization Committee can always call for the information from the concerned hospitals. 15. Clause (i) of Rule 6(F) of the said Rules clearly provides that the Authorization Committee is expected to take its decision expeditiously and use it discretion judiciously and pragmatically in all such cases where the patient requires immediate transplantation of the human organ. If along with the application, a certificate of a medical practitioner having super specialization in requisite branch is produced recording that the recipient requires immediate transplantation of human organ, if the Authorization Committee is satisfied about the genuineness of the certificate, an endeavour shall be made by the Authorization Committee to decide the Application as expeditiously as possible and preferably within a period of four weeks from the date of receipt of the application. In case of a kidney transplant, the certificate shall be of a qualified Nephrologist. All other applications shall be decided by the Authorization Committees in chronological order with reference to the respective dates of filing of the applications. For making departure, in exceptional cases, the Authorization Committee must record brief reasons. However, all applications shall be decided expeditiously and no one shall be made to wait for six months as done in one of the cases. 16. It is also necessary to digitalize the record of all applications filed before all the Committees so that data of all applications filed in store is available to each Committees. 17. For the time being, we issue the following directions.
16. It is also necessary to digitalize the record of all applications filed before all the Committees so that data of all applications filed in store is available to each Committees. 17. For the time being, we issue the following directions. (i) The State Government shall endeavour to provide requisite infrastructure in terms of separate establishment, separate staff and equipments etc. as set out in this order to all the Authorization Committees in the State as expeditiously as possible. An Affidavit containing the steps taken in that behalf shall be filed in this Court within a period of six weeks from today; (ii) An Authorization Committee is under an obligation to accept the Applications made in accordance with Sub-section 3 read with Sub-section (5) of Section 9 of the said Act and the Authorization Committee cannot direct the Applicants to apply through the concerned hospitals. We make it clear that only the Authorization Committee has jurisdiction to entertain the aforesaid Applications and no other Authority can entertain such applications; (iii) The State Government shall take all possible steps to fill in all the vacant posts of members of the Authorization Committees which are already established. The State Government shall constitute proper selection committees so that the vacancies can be filled in by appointing persons of repute having good integrity and character. The State Government shall endeavour to fill in all the vacancies within a period of six weeks from today. The State Government shall file an affidavit setting out steps taken in this behalf within a period of six weeks from today; (iv) If along with the Application under Sub-section (3) read with Sub-section (5) of Section 9 of the said Act, a certificate of medical practitioner having requisite super specialization in the concerned subject is submitted recording that the recipient is immediately required to undergo transplantation of human organ and if the Authorization Committee is satisfied about the genuineness of certificate, the Committees shall proceed to decide such Application by giving utmost priority and preferably within a period of four weeks from the date of submitting the Applications; (v) Such certificate of medical practitioner shall contain reasons in brief as to why urgent transplantation is necessary; (vi) All other Applications shall be chronologically decided by the Authorization Committees in accordance with their respective dates of filing.
A departure can be made by the Authorization Committees in exceptional cases by recording brief reasons in that behalf. All applications shall be decided expeditiously; (vii) We direct that sufficient funds shall be placed at the disposal of the Authorization Committees; The State shall ensure payment of reasonable remuneration/allowances to the members of the Authorization Committees; (viii) The State shall take steps to ensure that record of all applications under Section 9 (3) of the said Act is digitalized and made available to all Committees; (ix) Affidavit of compliance in that behalf shall be filed within a period of six weeks from today. The Petitions shall be listed on 6th August 2013 under the caption “Directions”; (x) The Authorization Committees shall decide the Applications in the light of this order as well as in the light of the law laid down by the Apex Court in the case of Kuldeep Singh (supra); (xi) The Writ Petition Nos.10 of 2013, 2719 of 2013 and 3220 of 2013 which have been disposed of will be listed on the next date only for the purposes of reporting compliance and for issuing necessary directions.