PREAMBLE:    Need for suitable legislation to augument supply of corneas: By Jashwant B. Mehta

The problem of blindness on account of corneal opacity in our country has remained almost as acute today as it was nearly thirty-five years ago when the first corneal transplant was performed. We have in India about ten million blind  people out of which about 10% to 15% are estimated to have lost vision due to corneal opacity. This figure further swells by the addition of about 25,000 to 30,000  new patients every year. A majority of  these blind patients are unfortunately young persons unlike the  cataract patients, who are usually in a higher age group. Research and advanced techniques of modern   surgery have made it possible to remove the opaque and defective cornea and replace it with a transparent healthy cornea. However, the new cornea to be transplanted cannot be artificially produced and has to be from a human body. As it is possible to use a cornea removed from a dead body, the necessity of removal of donor cornea from a living person does not arise.

It is estimated that in order to provide vision to over a million corneally blind people and to prevent further addition to this huge backlog, we need at least 40,000 to 50,000 pairs  of corneas every year for transplant.  As against this,  the current annual procurement is a mere 6,000 to 7,5000 pairs of corneas. Though the eye donation movement has been in existence in our country for the last twenty-five to thirty years, the statistics reveal that apart from mobilisation aspect, there is a strong need to support this activity by a suitable legislative measure.

The legislation has helped a great deal in several countries for overcoming the problem of the huge yawning gap between the demand and the actual procurement of corneas. Thus, in the US.A.  where the first eye bank was opened as far back as in 1945, the real momentum for the growth of eye banking and Keratoplasty has taken place after the suitable legislative measures were introduced in the mid-seventies. For example,  as against the total of 20,000 corneal transplants performed in  the U.S. between 1961 and 1971, the number of transplants touched a figure of 36,900 in 1988 alone. As against the 6000 eye donations received in 1967, the figure jumped to 83,758 in 1987.  There is practically no patient wait-list as of today. The provisions relating to the “Presumed  Consent” and ”Required Request”  incorporated in the U.S. legislation have played a great role in this regard, the details of which are given below.

Provision of Presumed Consent:

Marryland State was the first to enact a legislation in regard to “Presumed Consent” in 1975 and many other States have followed suit in enacting similar legislation. The beneficial impact of the passing of this Act in the Marryland was that the State of  Marryland became the largest supplier of corneas in the United States.

The Act enables the Chief Medical Examiner, the  Dy. Chief or an Asst. Medical Examiner, as the case may be, in any case where a patient is in need of corneal tissue for a transplant, to remove corneas from a dead body where the autopsy is required in accordance with the law (unless there is a pre-recorded objection of an intimation of objection from the next of kin of the deceased). It may be also mentioned that the corneas received from these medical / legal cases constitute the most concentrated source of  excellent quality tissue from relatively young donors predominantly deceased                                                                                                                             from trauma and it makes the Chief Pathologist  the pivotal figure in determining whether the eye collection will succeed or not. (As  compared to this, the quality of corneas procured from the dead body of a persons dying due to  old  age is a generally poor as the endothelium cell    count, which is vital for a successful transplant especially in the  case of a penetrating graft, deteriorates   as the  age advances. This is more so in a  developing  country like ours because of the generally poor standard of health of the average citizen.

In States where  the presumed consent laws have not been yet enacted and where the permission to remove tissue must be obtained from the family of the deceased, new acquisition techniques have been developed. Hospital or organ procurement agency  personnel  specifically trained in the appropriate technique are the most successful in approaching a bereaved family.

Provision of Required Request

Besides the inclusion of Presumed Consent, the Required Request provisions of the law enacted in many States in the USA, have also contributed to the increase in the volume of donor material. Under these provisions, it is mandatory for the individual hospital authorities to solicit eye donation from the next-of-kin in all cases of death. The effectiveness of this legislation has been varied depending on the specific terms of the law from State to State. Overall, however, this approach has had positive results.

Legislation in India  -  The Transplantation of Human Organs Act, 1994

Permitting Trained Technicians to Enucleate Corneas

Under Sec.3 (4) of the Act, only the Registered Medical Practitioner is authorised to remove a human organ including eyes, for therapeutic purposes.  This provision has the effect of  restricting the supply of eye donations by not allowing a technician duly trained in enucleation  procedure to remove eyes from the dead body for therapeutic purposes. It is, therefore, necessary to amend  the Act so as to extend the authority to remove the  eyes, to the duly trained technicians also in order to accelerate the supply of corneas . This is  the practice  in several  countries  including the USA, according to which the technicians  are certified  by the  Eye Banks. In India this can be  done  by Eye Bank Association  of India  which  body is now formally recognized  by the Director of  Ophthalmology ,Govt. of India. With formal  training of 3-6 months in eye banking  it is possible for any  person  with science educational background to perform  enucleation (Corneas are always removed  from dead bodies).  It may not  be  possible for a Medical Practitioner  to attend  enucleation calls  received  when deaths take place.

1.      Removal of Corneas from bodies sent for post-mortem  examination for Medico-Legal or Pathological  purposes

Section 6 of the Act provides that the person competent under the Act to give authority for the removal of any human organ from a dead body sent for post-mortem examination for Medico-legal or pathological purposes, has to satisfy that the deceased person has not expressed, before his death, any objection to any of his organs including eyes being used for therapeutic purposes after his death, or where he head granted an authority for the use of any  of his organs  including  eyes  for therapeutic  purposes  after his death,  he had  not revoked such authority before his death. In practice, it is very difficult for any Doctor performing the postmortem examination to                                                                                                                                         take upon himself the onus of giving the required certificate of his personal satisfaction in this regard as required by the Act. This provision therefore, needs to be suitably modified since cornea removal does not generally affect post-mortem findings like other organs viz. Kidney liver etc.

In this connection, we reproduce below Section 6 of the Act for ready reference.

Authority for removal of human organs from bodies sent for post-mortem examination for medico-legal or pathological purposes

6.      Where the body of a person has been sent for post-mortem examination __

(a)     for medico-legal  purposes by  reason of the death of such person having been caused by

accident  or any other unnatural cause, or

(b)    for pathological purposes,:

the person  competent  under  this  Act  to  give  authority  for  the removal  of any human 

organ  from  such  dead  body  may;  if  he  has reason  to  believe  that  such human organ 

will  not   be required  for   the purpose for which such body has been sent  for postmortem 

examination, authorise the removal, for therapeutic purposes,  of  that  human  organ  of the 

deceased person  provided that he is  satisfied that the deceased person  had  not  expressed, 

before  his death,  any  objection  to  any  of  his  human organs being used , for therapeutic 

purposes,  after  his  death  or,  where  he had granted an  authority for the use of any of his

human organs for therapeutic  purposes after his death, such authority had not been revoked

      by him  before his death.

The Section 6 (b) therefore,4 needs to be modified as follows:

“ the person competent  under  this Act to give authority for the removal  of any human organ  from such dead body may; if he has reason to believe that such human organ will not be required for the purpose  for which such body has been sent for postmortem examination, authorise the  removal, for therapeutic purposes, of that human organ of the deceased person provided that he is satisfied that the deceased person had not expressed, before his death, any objection to any of his human organs being used, for therapeutic purposes, after his death or, where he had  granted an authority for the use of any of his human organs for therapeutic purposes after his death, such authority had not been revoked by him before his death”.

                      3.      Inclusion of “Required Request” Provision.

The Act does not include  the provisions of “Required  Request” under which it is mandatory for the individual hospital authorities to solicit eye donations from the next  of kin of patients in all cases of death.  The inclusion of the provisions of “Required Request” in the Act, is necessary for increasing the supply  of donor eyes in the light of the experience of the U.S.A. where the enactment of suitable legislation incorporating the provisions of “Required Request” has played a pivotal role in increasing the supply of eyes substantially as indicated above.

                    4 .      Definition of the term “Unclaimed Body:

The  term  “Unclaimed  Body”  occurring in Sec. 5  of  the  Act has not been defined in  the Act, and therefore, needs to be defined as follows for facility of the  proper   implementation of the Act.

“Unclaimed Body” means (a) the  body of deceased person who was admitted in the

hospital without any address or who has not been visited in the hospital by any attendants from the time of his admission and remains unattended till death and has no relatives to claim his body within such time as may be prescribed; (b)  Dead body of a person or child recovered by the police as unclaimed; (c) A prisoner who does not get any letters or has not been visited by any relation in the jail  and dies or is hanged  and his body is not claimed by any relation”.

Contributed by Felix  : felix@theemerald.com