Balbir Singh vs The Authorisation Committee And ...
2004 Latest Caselaw 851 Del

ORDER

Manmohan Sarin, J.

1. Petitioner, Balbir Singh, 57 years old, suffering from Hepatitis-C related Cirrhosis of liver end stage disease with portal hypertension, filed this writ petition. He assailed the rejection of request for donation of liver by his brother Baljit Singh for transplantation. Petitioner required transplantation of liver. His brother Baljit Singh offered to donate part of his liver for transplantation. The Authorization Committee-respondent No. 1 of the Indraprastha Apollo Hospital-respondent No. 2 declined to permit transplantation. It did so since HLA Typing Test conducted on the donee Baljit Singh failed to establish his near relationship with the petitioner. The Authorization Committee intimated the petitioner that if he still wanted to proceed with the transplantation, a detailed study of other family members' HLA typing was required.

2. The petition came up before this Court on 21st January, 2004 when notice was issued to the respondents to show cause as to why rule nisi be not issued, returnable on 23rd January, 2004, with direction to the respondents to produce the record of the case through an expert Doctor to assist the Court. On 23rd January, 2004, respondents 1 & 2 represented by Mr. A.S. Chandhiok, Sr. Advocate with Ms. Nina Gupta and Dr. Raja Shekhar, Senior Consultant in Transplant Surgery presented the record. Mr. Chandhiok submitted on behalf of respondents 1 and 2 that objections as to the maintainability of the writ petition were not being raised as this was not an adversarial litigation. He submitted that the Hospital was only complying with the duty cast upon the medical practitioners under Rule 4(c) of the Transplantation of Human Organs Rules, 1995 (hereinafter referred to as the 'Rules'). The Hospital had carried out HLA-A, HLA-B and HLA-DR tests to establish that the donee was a "near relative" of the petitioner. As these tests did not match, they asked the petitioner to get the other tests done as specified in Sub-Clauses (ii) to (iv) of Clause (c) of Rule 4 of the Rules, from other family members, who may be available as donors.

3. On the factual matrix, petitioner was admitted in the Hospital on 22-11-2003. Tests were carried out on 11-12-2003 and the report became available on 13-12-2003. Thereafter, the petitioner was discharged. The Hospital had advised liver transplant on an urgent basis. Petitioner got readmitted on 8-1-2004. On 14-14-2004, the Hospital requested All India Institute of Medical Sciences to have Molecular Typing (RELP/ DNA Polymorphisms) tests to be carried out to establish genetic relationship between the donor and the recipient. Petitioner's parents were also dead.

4. It is common ground between the parties that petitioner's condition required liver transplantation urgently as his health was deteriorating. On 23-1-2004, Dr. Rajashekhar, Consultant in Transplant Surgery, Appollo Hospital gave his assessment on need and feasibility of Liver transplantation in the petitioner's case. Dr. Raja Shekhar candidly submitted that Surgery should ideally be done within a week and that AIIMS had been requested to carry out further tests as noted earlier, which were not available at the Apollo Hospital.

5. The Bench on hearing Dr. Raja Shekhar as well as perusing the available medical literature, found prima facie that in case of liver transplantation, unlike kidney transplantation, tissue matching was not of much consequence. The relevant factors in liver transplantation were the matching of the size and condition of part of organ being removed and the matching of the blood group. In other words, the size and healthy state of organ were required to be considered. These were critical and determinative factors and the requirement to ensure the donor being the "near relative" was not required from medical or scientific point of view for acceptability of the organ in transplantation. Besides, petitioner had produced credible evidence to establish that donee was brother of petitioner. Copy of School Leaving Certificate and passport of petitioner and donee, showing the name of father, certificate from a Member of Parliament knowing the family as well as a certificate from District Magistrate certifying the two were brothers. This evidence was found adequate by me to establish relationship. It was, therefore, directed that the Hospital could carry out operation forthwith without complying with the requirement of Rule 4(c) of the Rules to carry out further tests.

6. Respondents, thereafter, moved CM 1311/2004, wherein certain corrections and clarifications were sought to be incorporated in the order passed on 23rd January, 2004. The Court was informed that the petitioner had developed fever and there was also alteration in neurological status warranting a detailed evaluation by the Neurologist and imminent surgery was therefore not being undertaken. The Court noted that the directions to carry out transplant surgery without going through further tests as required under Sub-rule (c) of Rule 4 of the Rules was based on the report of the hospital itself that surgery was urgently required. It goes without saying that in case, either due to change in the condition of the patient or further investigation being required, the question of when surgery is to be undertaken, is best left to the discretion of the treating Doctors. Unfortunately, in this case, Court is informed that petitioner has since expired. Mr. R.K. Saini submitted that petitioner had incurred huge expenses to the tune of Rs. 4 lacs or so without receiving the ultimate treatment, which may have saved his life. Valuable time appears to have been lost in carrying out the HLA Typing test to establish the relationship, as required under Rule 4(c) for Liver Transplant.

7. The above case has brought to fore the need to re-examine and review the statutory provisions and rules, in the backdrop of difficulties which have surfaced from time to time, resulting in paradoxical situations. Stringent requirements and conditions were prescribed under the Rules to prevent unscrupulous and commercial practices. These have to be harmonized with the emergent needs of as critical patient requiring transplantation which necessitates a quick and responsive mechanism. Equally relevant is to consider the functioning of the Authorization Committee constituted under Section 3 of the Transplantation of Human Organs Act, 1994 (hereinafter referred as 'the Act'). Towards this end, respondents 1 and 2 were directed to file an affidavit giving the status with regard to the cases decided by the Authorization Committee in the last six months. Information on number of permission granted, where the donor and the donee were not related, the factors taking into consideration while granting such permission. Union of India was also directed to file an affidavit giving the composition of the Authorization Committee as approved. The directions have been complied with and affidavits filed.

8. Let me at this stage notice the provisions relevant for the present exercise.

3. Authority for removal of human organs :--

(1) Any donor may, in such manner and subject to such conditions as may be prescribed, authorise the removal, before his death, of any human organ of his body for therapeutic purposes.

(2) to (3)  xx       xx       xx       xx
 

(4) The authority given under Sub-Section (1) or Sub-Section (2), as the case may be, Sub-Section (3) shall be sufficient warrant for the removal, for therapeutic purposes, of the human organ; but no such removal shall be made by any person other than the registered medical practitioner
 

(5) to (7) xx xx xx xx
 

Sub-Sections (2) and (3) deal with the cases of removal of organs upon the death of the persons. Sub-Sections (5), (6) and (7) deal with the removal of organs from the body of a deceased person or brain-stem death cases.
 

Section 9 of the Act reads as follows :--
 

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 authorises 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 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 authorises 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 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 there under, grant to the applicants approval for the removal and transplantation of the human organ.

(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 there under, it shall, for reasons to be recorded in writing reject the application for approval.

Some of the definitions as given in Section 2 of the Act may be noticed :--

2(f) "donar" means any person, not less than eighteen years of age, who voluntarily authorises the removal of any of his human organs for therapeutic purposes under Sub-Section (1) or Sub-Section (2) of Section 3;

2(h) "human organ" means any part of a human body consisting of a structured arrangement of tissues which if wholly removed, cannot be replicated by the body;

2(1) "near relative" means spouse, son, daughter, father, mother, brother or sister;

2(m) "recipient" means a person into whom any human organ is, or is proposed to be, transplanted.

2(o) "therapeutic purposes" means systematic treatment of any disease or the measures to improve health according to any particular method or modality; and

2(p) "transplantation" means the grafting of any human organ from any living person or deceased person to some other living person for therapeutic purposes.

Section 24 of the Act has enabled the Central Government, by notification, to make rules for carrying out the purposes of the Act. Sub-Section (2)(a) of Section 24 reads as follows :--

24. Power to make Rules :-- (1) The Central Government may, by notification, make rules for carrying out the purposes of this Act.

(2) In particular and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely :--

(a) the manner in which and the conditions subject to which any donor may authorise removal before his death, of any human organ of his body under Sub-Section (1) of Section 3;

9. Pursuant to the powers under Section 24 of the Act, the Central Government framed the Transplantation of Human Organs Rules, 1995 (hereinafter referred to as the Rules). Rule 4 of the Rules reads as under :--

4. Duties of the Medical Practitioner.--(1) A registered medical practitioner shall, before removing a human organ from the body of a donor before his death, satisfy himself--

(a) that the donor has given his authorisation in Form 1;

(b) that the donor is in proper state of health and is fit to donate the organ, and shall sign a certificate as specified in Form 2.

(c) that the donor is a near relative of the recipient, and shall sign a certificate as specified in Form 3 after carrying out the following tests on the donor and the recipient, namely :--

(i) tests for the antigenic products of the Human Major Histocompatibility system HLA-A, HLA-B and HLA-DR using conventional serological techniques;

(ii) tests to establish HLA-DR beta and HALDQ beta gene restriction fragment length polymorphisms;

(iii) where the tests referred to in Sub-Clause (i) and Sub-Clause (ii) do not establish a genetic relationship between the donor and the recipient, tests to establish DNA polymorphisms using at least two multi-locus gene probe;

(iv) where the tests referred to in Sub-Clause (iii) do not establish a genetic relationship between the donor and the recipient further tests to establish DNA polymorphisms using at least five single locus polymorphic probes.

(d) in case recipient is a spouse of the donor, record the statements of the recipient and the donor to the effect that they are so related and shall sign a certificate in Form 4.

10. The Transplantation of Human Organs Act, 1994 was enacted to meet the need of a comprehensive legislation for regulating the removal of organs from cadavers and living persons and prohibiting commercial dealings in human organs. The advances in the field medicine, science and technology has made it possible to remove organs from living as well as deceased persons and to transplant such organs to save lives of suffering human beings. This also brought with it the evil of mal-practices and commercial dealings in human organs. With a sizable population living below poverty line, the danger of exploitation by sale of organs due to compelling economic necessity is real in India. It was in this background that a comprehensive law for regulating the removal and transplant of human organs i.e. the Transplantation of Human Organs Act, 1994 (hereinafter referred to as the Act) was enacted. It came into force on 4-2-1995. The Act became applicable to the States of Goa, Himachal Pradesh, Maharashtra and to all Union Territories.

11. Notwithstanding the safeguards provided under the Act there have been cases, particularly in kidney transplant, of exploitation of poor persons where either in garb of donations, affection or special circumstances, with involvement or connivance of medical practitioners, transplantation of organs is done for consideration. The donors receive a pittance, while the middlemen and others retain the cream. There are also cases of deception or clandestine removal of organs from unaware and unsuspecting persons.

In the present case, we are primarily concerned with the bottlenecks and difficulties in cases where permission is sought as also with cases where medical tests are required to be carried out to establish relationship. It was to curb commercial dealings in the transplantation of organs that safeguards in the Act and stringent provisions in the Rules, providing for scientific tests to establish the factum of relationship between the donor and donee were prescribed.

12. A conjoint reading of the above provisions shows that Section 3 of the Act provides for authorization by a person, before his death for removal of any human organ of his body for therapeutic purposes, subject to such conditions as may be prescribed. Sub-Section (4) of Section 3 of the Act provides for removal of organ only by Registered Medical Practitioner upon such authorization. Sub-Section (1) of Section 9 of the 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. "Near relative" as noticed earlier has been defined as spouse, son, daughter, father, mother, brother or sister. Sub-Section (3) of Section 9 of the Act provides for permitting transplantation in cases where the recipient is not a near relative, but the donor by reason by affection or attachment or other special reasons is donating the organ for transplantation. Such transplantations cannot be done without approval of the Authorization Committee constituted under Sub-Section (4) of Section 9 of the Act. Section 24 of the Act empowered the Central Government to make Rules for carrying out the purposes of the Act. Clause (a) of Sub-Section (2) of Section 24 of the Act prescribes the manner in which and the conditions subject to which any donor may authorise removal, before his death, of any human organ of his body under Sub-Section (1) of Section 3. This Section further prescribes the form and the manner in which a brain-stem death is to be certified etc. and the manner of removal of organ from unclaimed dead body etc. Section 4 of the Act prohibits authorization for removal, of organs, being given from the body of deceased persons, where there are reasons to believe that an inquest may be required. Section 5 of the Act provides for authorization for removal of organs in case of unclaimed bodies in hospitals etc. Section 6 deals with the removal of organs from bodies sent for postmortem where organs are not required for purpose for which the body has been sent for post-mortem etc.

13. Rule 4 of the Rules requires the medical practitioner to comply with the requirements specified therein before removing a human organ from the body of a donor. Form 1 is a declaration by the donor authorizing removal of the organ for donation to the donee who is to be his "near relative". The medical practitioner is also required to satisfy himself regarding proper state of health for donation of the organ. Matter do not end here. The medical practitioner is further required as per Form 3 to certify that the donor and the donee are related to each other and the fact of this relationship is established by the results of the tests for the antigenic products of the Human Major Histocompatibility system. The tests required to be carried out are prescribed under Clause (c) of Rule 4 of the Rules.

14. Under the scheme of the Act, the cases which are required to be referred to the Authorization Committee for approval are those which are not cases of donation from a "near relative". The Authorization Committee is to approve such cases only if it is satisfied as to the existence of affection or attachment between the donor or recipient or any other special reasons. In such cases, the question of tissue matching and of the acceptability of the organ being transplanted is left to be determined by scientific and medical tests to be carried out. In other words, once the Authorization Committee is satisfied as to the reasons for donation, falling within Sub-Section (3) of Section 9, the other aspect of tissue matching for acceptability of the organ are left to Medical Practitioners. However, in the case of a "near relative", unlike that of a non "near relative", the very factum of relationship is sought to be established by the various tests prescribed under Sub-Clause (c) of Rule 4 of the Rules.

15. In the light of the foregoing statutory provisions, let us examine the present case. The petitioner was in emergent need of a liver transplant. His younger real brother was willing to donate part of his liver. Unimpeachable documentary evidence in the form of school leaving certificate showing common parents, passports, certificate by a Member of Parliament, who knew the family and the parents of two brothers, certifying and attesting their photographs as brothers had been produced. Additionally, a certificate from the SDM and the District Magistrate as to the factum of relationship has been produced. In the instant case, Authorization Committee declined the request and required further testing in terms of Sub-Clauses (ii) and (iii) of Sub-rule (c) of Rule 4 of the Rules. These tests were not available even in a well, equipped state of art hospital such as Indraprastha Apollo Hospital. The petitioner appears to be correct in his submission that the petitioner's case being that of "near relative" was not required to be sent to Authorization Committee.

16. 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 transplant and/or living liver donations should be deleted."

17. 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.

18. The working of the provisions of the Act and the Rules have brought to fore, need for a re-look at the working and practical problems faced in its implementation. As discussed above "near relative" in Section 2(i) of the Act has been sought to be equated with medically confirmed "near relative" under Rule 4 of the Rules. Once it is shown that for medical and scientific reasons, medical tests are not required to be carried out for determining the tissue and organ acceptability then the factum of "near relative" need not be established by medical evidence and the same can be established from other credible evidence, requiring no tests and certificates from Doctors subjecting the patient and the donee to avoidable delay, expense and agony.

19. The authorities would be well advised to bring about a segregation in the roles of the Designated authority and medical practitioners as far as the question of determination of donor and donee being the "near relative" is concerned. Essentially the role of the medical practitioners should be confined to assessing by scientific and medical tests to determine whether the donated organ would match and be acceptable for transplantation by the donee by carrying out requisite tests. In the event, the factum of the donor and donee being the "near relative" is in doubt, the determination thereof cannot be left to the Medical Practitioner and the same ought to be established on the basis of other credible evidence only by the Designated authority or Authorization Committee, for which purpose its consideration zone would need to be enlarged. Perhaps in cases where other evidence is not credible or leaves a doubt then resort to medical tests can be had for conclusively determining the relationship.

Thus the primary responsibility for determination of "near relative" being left to the Designated authority and not by carrying out the prescribed medical tests, which may be resorted to in case of doubt. This is an aspect which needs to be considered by the respondents.

20. In USA and other western countries transplantation of human organs is done at a larger scale. There are association's, institutes and data banks which help in organ procurement. United States has also developed a system where the donee of an organ receives recognition and honour by the community. Certain benefits are given. These benefits include priority allotment in case the donee or any immediate member of his family requires an organ for transplantation. A plaque or wreath on passing away of donor are placed to honour him/her in community. The US Department of Health and Human Services Advisory Committee on Organ Transplantation has made 31 recommendations, which cover the ethical principles to be followed to ensure that there is informed consent for organ donation. The recommendations cover the entire conspectus of organ donation, from setting up of procurement centres, resource centre for living donors etc. Presidential assent was given to the Organ Donation and Recovery Improvement Act by the President of United States of America. The law provided $ 25 millions in terms of resources for efforts to increase donation. The law provides for grants for reimbursement of travel and subsistence expenses and incidental non-medical expenses incurred by the donors. Allocations have been made for demonstration projects to increase organ donation and awareness of the same. It provides for grants to qualify Organ Procurement Organizations and hospitals to establish programmes coordinating organ donation.

21. Each society and community has to develop and devise its principles and guidelines as per the prevalent norms of the Society for organ donation and transplantation. One norm which can be said to be all pervasive across the world is that trading and commercialization and exploitation in Organ Transplantation is discouraged and avoided. The donor can either be a relative other than a "near relative" or even an outsider, for which approval for transplantation is required to be given by the Authorization Committee under Section 9 for reason of affection, or attachment or other special reasons. The Donors falling in either class deserve protection and priority in treatment should the need arise for them. Similarly these benefits could be extended to family members of deceased who authorized donation of organs.

22. The respondents could consider creation of a fund for providing medical aid and help to donors. Part of the corpus of the fund could come from the Union of India and the balance by levying a fixed charge say 2 to 5% on the total bill of the hospital for transplantation of the organ. Public donations for this cause may also be encouraged. The fund could then be utilized to render economic aid and help to the donors who may require the same in future as per the provisions of the fund.

23. I consider it appropriate that a Committee be constituted to review the provisions of the Act and the Rules in the light of observations made in the judgment. The Committee to consider, examine and give its report to the Central Government on the following :--

1. Based on the date available on the transplantation of organs and the working of the. Authorization Committees, the Committee to examine and make its recommendations on the composition of Authorization Committees and changes, if any, required to ensure timely permissions.

2. Whether the jurisdiction of the Authorization Committees should be enlarged by bringing within its ambit the process of certifying a "near relative" or the task be assigned to another Designated authority ?

3. Review the provisions of the Act and Rules based on the experience of transplantation of organs as carried out and the difficulties arising due to the bottlenecks faced in the said process. The Committee to examine in particular provisions of Section 9 and requirement of carrying out the tests prescribed in Rule 4, certification in Form 3 to review the definition of "near relative" and make its recommendations in the light of the observations made :--

4. Examine and specify the organs for transplantation of which the tests prescribed in Rule 4(1)(c) to establish the factum of being "near relative" need not be carried out when other evidence is available.

5. Examine the feasibility of establishing and setting up Organ Procurement Organizations with data bank to facilitate the dissemination of information on availability of organs for transplantation. To encourage organ donation especially from cadavers, cases of brain-stem deaths and other deceased persons, who had authorized removal of organs upon demise.

6. Examine the feasibility of creation of a fund, the corpus to be provided partly come from the Union of India and partly by levying a fixed charge on the total bill of the hospital for transplantation and/or public donations, for providing to a donor social incentives, medical aid and facility of transplantation of organ in future, should the same be required.

7. Examine and recommend ways and means to give social incentives, including but not limited, to help and aid and preferred health care, recognition and honour to a donor in the community.

8. Examine the causes that lead to exploitation of poor and unaware persons in the process of organ donation and suggest methods to reduce, control and ultimately eradicate such mal-practices. Recommend programmes for dissemination of correct information of ethical, legal and devising procedure concerning organ donation so that a conducive atmosphere is generated and disinformation and misgivings are dispelled.

9. Any other matter relevant to the subject.

The composition of the Committee shall be the following :--

(i) Secretary, Ministry of Health or his nominee being an officer not less than the rank of Additional Secretary, Ministry of Health, as the Convenor.

(ii) Director General of Health Services or the Addl. Director General of Health Services as the Member Secretary.

(iii) The Head of Department of Surgery, AIIMS;

(iv) Dr. Harsh Johri, Renal Surgeon, Sir Ganga Ram Hospital,

(v) Secretary of the All India Medical Association; and

(vi) Mr. Sanjay Jain, Advocate, Chamber No. 488, New Chambers Block, Delhi High Court, New Delhi.

The Committee to give its report and recommendations to the Government within four months. Copy of the same be placed on record.