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