1. As the issues raised in the writ petition relates to the working of Transplantation of Human Organs Act, 1994 ( hereinafter referred to as " TOHO Act, 1994"), keeping the urgency and the need of the petitioner to obtain transplantation of his kidney, the operative part of the judgment was passed on 20.8.2010 which reads as follows: "The report sent by the Professor and Head, Department of Nephrology, AIIMS New Delhi in sealed cover is opened and brought to the notice of the learned counsel for the parties. We have perused the report. We allow the writ petition and approve the application of the petitioners for donation of kidney by petitioner no.2 Nilakantha Muduli to be transplanted to petitioner no.1 Arup Kumar Das. Detailed order to follow."Hence, this judgment.
2. Petitioner No.1, namely, Arup Kumar Das, aged about 28 years, who is an advocate by profession, is suffering from kidney failure and is surviving by undergoing regular dialysis from time to time. On the advice of the medical specialist attached to the Kalinga Hospital, Bhubaneswar, the petitioner has been advised to undergo kidney transplant. Petitioner No.1 could not obtain a donor from within his family, since the brother who had agreed to be a donor was a diabetic, for which reason he was medically unfit to be a donor. Petitioner No.2, namely, Nilakantha Muduli, aged about 35 years (a non-family member) came forward to donate a kidney in favour of the petitioner.
3. From the records of the proceeding, it appears that the application of the petitioner Nos.1 and 2 was forwarded to the "Authorisation Committee", set up by the State Government under Section 9(4)(b) of the TOHO Act, 1994, which rejected the said application. The petitioners preferred an appeal before the appellate authority under Section 17 of the TOHO Act, 1994 and the said appellate authority affirmed the order of the Authorisation Committee and rejected the prayer of the petitioners on the following grounds: "(I) In the deposition given by Sri Muduli (donor) during the enquiry by Nizarat Officer in the office of Sub- Collector, Ganjam (copy enclosed by Collector, Ganjam in his letter No.150/RC dtd. O2.04.2009) it appears that he came to know about kidney requirement of Sri Arum Kumar Das from the advertisement published in the Oriya daily, 'The Samaj' dtd. 25.10.2008. He also mentions that he knows donee for last 2 years only. (II) The donee, Sri Arum Kumar Das, also in his deposition mentions he knows donor for last 2 years & that he bought cashew from him on his visits to Chatrapur from Koraput.
(III) The donor is from Koraput & used to vist Chatrapur occasionally for purchasing cashew nuts.
Further, the Authorization Committee while rejecting the application have also mentioned that HLA matching is poor.
(IV) No other documents (photographs etc.) were shown by the donee/donor showing their emotional attachment."
4. The petitioners approached this Court in WPC No.18307 of 2009 seeking to challenge the appellate order and the same came to be disposed of by this Court by its order dated 11.05.2010 with the following findings:
"On perusal of the grounds on which the appeal has been dismissed, we found that the only tenable ground may be that HLA matching is poor, as has been observed by the Authorization Committee. So far as relationship between both the petitioners and the willingness of the donor to donate one of his kidneys are concerned, the grounds taken for rejection of the appeal do not appear to be reasonable. For example, in ground no.4 it is stated that no documents/photographs were shown by the donor/donee showing their emotional attachment. There cannot be any document to prove any kind of emotional attachment, and therefore, such a ground could not have been taken by the appellate authority for rejecting the appeal.
We, therefore, set aside the order Annexure-2 and remand back the mater to the Commissioner-cum-Secretary to Government to reconsider the appeal and dispose of the same within fifteen days from the date of communication of this order. We fix a time frame considering the urgency of the case."
5. On remand of the matter to the appellate authority, it appears that the appellate authority while took note of the fact that the High Court had observed that, "the only tenable ground is the poor HLA matching" yet the Authorization Committee rejected the petitioners' appeal once again reiterating the same very grounds on which the petitioners' application had earlier been rejected. It appears from impugned order (under Annexure-3) dated 16.6.2010 passed by the Commissioner-cum-Secretary to Government, in the capacity of the appellate authority under the TOHO Act, 1994, that it sought for the views of the DMET on the alleged poor HLA matching and its implication on donor and donee. The DMET furnished its opinion vide its letter No.8782 dated 8.6.2010 to the following effect:
i) HLA matching determines the graft survival in the donee in Kidney transplantation. If there is poor HLA matching then, the transplanted Kidney in the donee suffers from chronic rejection. The process of rejection starts after two years and progresses further, so that, the patient goes back to chronic renal failure again requiring homodialysis.
ii) Regarding un-related Kidney transplantation with poor HLA matching, the Donee is to be put on High dose Immune-Suppressive-Therapy which may have deleterious effect on the donee by increasing the incidence of infection.
iii) Kidney transplantation between two un-related Donor and Donee having poor HLA matching may prove to be futile exercise throwing both the Donor and donee with the risk of major surgical procedure.
iv) Studies have consistently shown a step wise increase in early rejection and decrease in long term graft survival with increasing in nos. of HLA antigen mismatch. In cadaveric renal transplantation, it is shown that HLA matched Kidneys. In the interest of the common people cadaveric transplantation should be initiated to avoid live unrelated transplantation. Relying heavily upon the opinion of the DMET, once again the appellate authority rejected the application of the petitioners.
6. In the circumstances as noted herein above, the writ petitioners had to once again approach this Court in the present writ application seeking to challenge the order in Annexure-3 passed by the Appellate Authority, with a prayer seeking for a direction to the Opp. Parties to approve the application of the petitioners for donation of kidney by petitioner No.2 to be transplanted with petitioner No.1. When the writ application came for admission before this Court, on 5.8.2010, learned counsel for the petitioners placed reliance on a certificate granted by Dr.Nisith Kumar Mohanty, consultant Nephrology of Kalinga Hospital in which he expressed his view that, since Arup Kumar Das (Petitioner No.1), the recipient and Nilakantha Muduli (petitioner No.2), the donor, are "unrelated", HLA matching is not applicable, since they were selected for surgery on the basis of "cross match test".
7. Apart from the above, the petitioners have also filed various documents including the articles down-loaded from the internet in order to support the views expressed by Dr.N.K.Mohanty of Kalinga Hospital. These articles state that, "the significance of HLA matching decreased while the results improved with the new immunosuppressant drugs" and those observations support the hypothesis that the weakened importance of HLA matching may be a consequence of the increasing efficacy of the immunosuppressant drugs. Apart from the above, it appears from copies of various American Medical Journals filed by the petitioners that, the Members of the American Society of Transplant Surgeons, were of the view that, the degree of HLA mismatch no longer matters and while it was still widely accepted that HLA matching is highly relevant. Dr. Jayme Locke, M.D. and her colleagues who made the presentation before the American Society of Transplant Surgeons, analyzed the data from 76,346 adult primary live renal donor transplant recipients between 1990-2007 and after analysis, they were of the view that, the "degree of HLA mismatch", donor and recipient relationship (live related renal donor 'LRRD' vs. live unrelated renal donor 'LURD', and by transplant era (1990-1999 v. 2000-2007, they were of the view that, "the increasing degrees of HLA mismatch did not co-relate with a stepwise reduction in graft survival after LURD transplant. In addition, HLA mismatches did not confer a reduction in graft loss risk. Accordingly, the investigators concluded that HLA matching should be considered only when choosing among 'related' live donors and that HLA should not be used to match the right donor to the right recipient in an incompatible KPD pool.
Considering the view expressed by the Dr. N.K. Mohanty of Kalinga Hospital and various medical articles brought to our notice, the documents produced by the learned counsel for the petitioners were directed to be submitted before the Authorisation Committee with a request to submit its views on the same.
8. On 11.8.2010 the report of the Authorisation Committee pursuant to our earlier direction dated 5.8.2010 was produced before us and on going through the said report dated 9.8.2010, we were of the considered view that the Committee had not complied with our directions, since in its report, except quoting one stray sentence from one of the medical articles submitted for their consideration, they reiterated their earlier view and that too, without even referring to the "conclusion" reached in the very article from which a stray observation was quoted. Further, in order to try to strengthen their view, they sought to once again refer to various other aspects regarding the authenticity of the link between the donor and the recipient as well as the failure on the part of the petitioners to produce any old photographs to establish that they (i.e. doner and donee) were known to each other for a long period of time. Further, they expressed doubts over the relationship of the donor with the donee. Since the donor had stated that he used to purchase cashew nuts from the donee's cashew plantation and sought to infer the existence of an objectionable "commercial relationship".
9. All these issues referred to by the Committee had been categorically rejected by this Court in the earlier writ petition i.e. WPC No.18307 of 2009 by its order dated 11.5.2010. Therefore, this court was left with no other alternative other than to direct vide order dated 11.8.2010, the Director of All India Institute of Medical Science (AIIMS), New Delhi to refer the matter to the Super Specialist of Nephrology and to re-examine and consider the report submitted by the Authorised Committee, as well as the materials submitted by the petitioners' to substantiate their plea that "HLA matching should only
be considered when choosing among related live donors and has no bearing in the present case, since the proposed donor is not a relative of the donee. Pursuant to this direction, the Medical Superintendent of AIIMS under the cover of his letter dated 14.8.2010 forwarded the report of Dr. Sanjay Kumar Agarwal, Professor and Head of the Department of Nephrology dated 13.8.2010. We can do no better than quoting the said report in its entirety.
In living renal transplantation, there is no doubt that HLA matching does effect long-term graft survival, though the impact of HLA matching on long-term graft survival is decreasing with the availability of newer and stronger immunosuppressive medicines.
Further, in a related donor and recipient combination, use of HLA is much more for deciding relationship. If we have more than one living related donor possible, that too if they are siblings, then one xcan depend upon degree of matching for choosing out of many living siblings donors.
In an unrelated donor and recipient combination, unless the donor pool of such unrelated donors is very large, it is unlikely that unrelated donor with match for HLA with the unrelated recipient. Further, if one has single unrelated donor being evaluated for a said recipient, then role of HLA matching is of not much importance as we are unlikely to get some reasonable degree of matching. If other tests of matching like cross matching are negative, one should go for transplant even if there is no HLA match out of 6 HLA usually done. In single unrelated donor and recipient combination, it may be possible that many treating team may be doing only cross-match and even do not do HLA matching. Thus, in a single unrelated donor and recipient combination, absence of HLA matching should not be a reason for denying renal transplantation."
In view of report of Dr. Sanjay K. Agarwal, Professor and Head of the Department of Nephrology, AIIMS, New Delhi, permission was accorded to the petitioners vide order dated 20.08.2010.
10. In the light of the circumstances narrated herein above and since the issues raised has wide implications for the donor and donee of organs covered under the TOHO Act, 1994, the present case has brought to our notice numerous bottlenecks and difficulties faced in cases where permission is sought, as also with cases where medical tests are required to be carried out for the purpose of consideration by the Authorisation Committee.
11. It is by now well settled in law that TOHO Act, 1994 was enacted as a comprehensive legislation for regulating the removal of organs from cadavers and living persons and prohibiting commercial dealings in human organs. It is a well accepted principle incorporated in the said Act which recognizes the technology by which it is possible to remove organs from living and deceased person and transplant such organs to save life of suffering human beings. This advancement of science, medicine and technology has also brought with it the evil of mal-practices and commercial dealings in human organs keeping in view the economic reality of huge part of our population living below poverty line and the danger of exploitation by sale of organs due to compelling economic necessity in our country. It is in this background that TOHO Act, 1994 was enacted. Various procedural requirements/safeguards have been created both in Act and Rules for ensuring that there is no exploitation and no commercial dealing in human organs. Even then, under the enactment of TOHO Act, a donor may be a relative or a non-relative and may even be an outsider for which approval of transplantation is required to be given by the Authorisation Committee under Section 9 for the reason of affection and attachment with the recipient.
12. At this juncture, it becomes necessary to refer to a judgment of the Delhi High Court in the case of Balbir Singh v. The Authorisation Committee and Others, AIR 2004 Delhi 413 wherein Justice Manmohan Sarin while dealing with a case of "Liver transplantation" discussed the relevance of "HLA type matching" in paragraph-16 of the said judgment which reads as follows : "Be that as it may, opinion of the Doctor as recorded before the Court and based on the medical literature as produced, the Tissue Matching and/or HLA type matching is not even essential in the case of liver transplant. Besides, Dr.Raja Shekhar, Dr. Aggarwal of AIIMS submitted that HLA typing and HLA matching were essentially for kidney transplant. In siblings, HLA typing does not necessarily match. It is not necessary that HLA typing should be identical even if there is any HLA typing antigens up to 30 40%, it could be taken as a case of HLA typing being satisfactory. HLA typing in kidney transplant is insisted upon for longevity of the graft. The tests for transplant of other organs such as carnial grafts, heart transplant, position is similar to that of liver. In case of liver transplant, prominent and determinative factors are the body weight, liver mass and blood groups. Although, there is some debate that HLA typing and matching can be desirable even in case of liver transplant, there is no conclusive scientific evidence to so establish. As a matter of fact, the recommendations made by the US Department of Health and Human Services Advisory Committee on Organ transplant in recommendation No.6 stated as under :
"Recommendation No.6.
That the requirement for HLA typing of liver and/or living liver donations should be deleted."
It is most important to note here that scientific development is a continuous process and new developments are taking place at all times at an extremely fast pace to meet the primary needs of human being. Considering the dev elopement of science till the stage at which the aforesaid judgment was rendered, directions issued contains in paragraph-17 of the judgment which quoted herein below: "In view of the foregoing discussion and authoritative medical opinions as noted above, it is held that requirement of test specified in Sub-clause (c) of Rule-4 need not be gone through in case of liver transplants to establish the factum of near relationship between the donor and donee. The factum of 'near relative' between the donor and the donee can be established in such cases by other acceptable evidence. It is when other evidence is not available or is doubtful that resort to the tests prescribed may be had."
13. Even though at the time when the aforesaid judgment was passed, the experts were of the view that, HLA typing in kidney transplant is insisted upon for longevity of the graft. The various articles brought to our notice by the learned counsel for the petitioners and as quoted herein above, would show that, there has been substantial growth in medical science and in particular, in development of immunosuppressive drugs, for which reason the experts in the field of transplantation of kidney have opined that HLA matching should be considered only when choosing among related live donors and that HLA should not be used to match the right donor to the right recipient in an incompatible KPD pool. At this juncture, the views of Dr.Sanjay K. Agarwal, Professor and Head of the Department of Nephrology, as referred to herein above, are of great importance since he has categorically stated:
"Thus in a single unrelated doner and recipient combination, absence of HLA matching, should not be a reason for denying renal transplantation."
14. We also feel it essential to point out herein that the various objectives of TOHO Act, 1994 and the intention of the Parliament in enacting the present legislation appears to have not been properly understood by the statutory authorities who have been vested with the responsibility of enforcing the said Act. What must not be lost sight of is that, transplantation of human organs has not been prohibited but regulated in terms of the said statute. What has been prohibited under the statute is commercial dealings in human organs and prevention and exploitation of humans for financial benefits. The Authorization Committee as well as the appellate body must endeavour to ensure that while exploitation must be prevented and commercialization dealing in human organ is prohibited, yet bona fide applicants may not be viewed in a suspicious manner since the TOHO Act, 1994 itself permits not only the doners from within the family but also permits non-relative doners.
We are of the considered view that the TOHO Act, 1994 should not be interpreted in a manner which effectively amounts to prohibiting transplantation of human organs. In conclusion, we may state that the TOHO Act, 1994 is enacted by the Parliament for regulating transplantation of human organs and only prohibits commercial dealings in human organs.
15. In course of hearing of the present writ application, this Court found that even though the TOHO Act, 1994 has come into existence for more than 16 years, yet the aims and objectives of the said statute remain largely unfulfilled. We are, therefore, of the view that the following directions are necessary in order to attain the objectives behind the legislation:-
(i) The State Government may issue necessary directives to the Authorisation Committees to the effect that, while dealing with applications for Kidney transplantation, in the case of a single unrelated doner and recipient combination, absence of HLA matching should not be a reason for denying permission for renal transplantation.
(ii) Having regard to the observations made in this order, the State Government may consider reconstitution of the Authorisation Committee with competent members who possess up to date knowledge and have kept pace with scientific developments that are taking place from time to time.
The Secretary in the Department of Health,
Union of India shall convene quarterly/half yearly meetings of all the Members of the Authorisation Committee of all the States, in order to keep them apprised of all scientific development which are likely to have a bearing in the exercise of their authority under the TOHO Act, 1994.
(iii) The State Government is directed to set up facilities for removal, storage and transplantation, at all the three Government Medical Colleges in the State and for the aforesaid purpose, necessary financial support to such Government hospitals must be provided at the earliest. Competent medical personnel may also be recruited/posted for the aforesaid purpose.
(iv) The State Government is directed to issue necessary Notifications fixing time limits within which period the applications for transplantation of human organs may be processed by the Authorisation Committee and time limit also be fixed for disposal of the statutory appeals.
(v) The State Government is directed to issue necessary direction fixing time limits for dealing with the applications under Chapters-III and IV of TOHO Act, 1994.
With the aforesaid observations and directions, the writ application is allowed.