The need for Separating Corneas from Other Organs in THOTA (Transplantation of Human Organs and Tissues Act)
Author: Jaswant Mehta, Founder Member &Ex President, Eye Bank Association of India (EBAI) & Chairman (Board of Advisor) & Managing Trustee, EBCRC
When we talk about eye donation it is mainly about the retrieval of corneas from the human body after death. The cornea is a transparent outermost layer of the eye and can be compared to the camera's lens. Light goes into the eyes through cornea-like lenses in the camera. In case of any injury to the eye due to any accident or any infection to the eye, the cornea gets damaged and the light cannot enter the eye. This condition is called corneal opacity. Thus even if the other organs of the eye like the retina etc. are intact, there will be no vision. Unlike other organs such as kidney, liver, heart etc. which have to be retrieved before the actual death takes place; the endothelium cells in the cornea remain alive up to 6 hrs after death and if retrieved within this period it is viable for transplantation.
Present status of corneal opacity & eye donation:
While there are several causes of blindness such as Cataract, Glaucoma or Retina detachment, the no. of people who suffer from corneal opacity are estimated to be about 8 to 10% of the total blind which works to about the 3/4 (three quarter) of the million people who can be benefited from the corneal transplant
Before the pandemic which has badly affected eye donation activity, we had around 25000 corneal transplants per annum taking place in our country. To eradicate corneal blindness in a reasonable time frame of say 10 years, we need to perform at least 100000 transplants per year. To give some idea about the USA which is having 30% of our population, on average they perform 50000 transplants every year.
Why separate Acts necessary for Eye donation & Corneal transplant vis-à-vis Lever, Kidney & Heart:
The parameters of corneal transplant & transplant of other organs are vastly different.
We need to separate the cornea from the other organs and have favourable legislation. When HOTA was being enacted in 1994, we had prepared a model corneal Grafting Act & submitted it to the parliament. Unfortunately, our lawmakers have never taken note of this & this has seriously retarded our progress.
We started eye donation activity way back in the mid-fifties. But in 65 years our progress is very slow. Several countries including the USA have separated cornea from other organs & have proactive legislation & their progress has been much better than ours. To give you some idea during the 10 years between 1961 & 1971 they had a total of 20000 transplants performed. After proactive & favourable legislation was enacted in various states in the mid-70s and 80s, the number of eye donations which was a mere 6000 in 1967, touched a huge figure of 36000 in 1988. Presently in the USA, apart from performing 50000 transplants, they have surplus corneas which are sent to other countries where there is an acute need, the number being 20000 to 25000 per annum.
Having cornea clubbed with other organs, has hampered eye donation activities. Till 2012 it was mandatory to have a registered medical practitioner enucleate the eyes. There were several obstacles created in HOTA including the requirement of a registered medical practitioner for retrieval of the cornea. In large numbers of eye donations, the retrieval of eyes has to be done at the home of the deceased and it was difficult to have registered medical practitioners who could spare the time of at least 2 hrs required for this process. It was only in 2012 when HOTA was replaced with THOTA, that we could manage to set this amendment.
However, except for this cornea is still clubbed with other organs & we have no provision for Required Request & Presumed Consentwhich has helped the other countries to achieve much faster progress in eye donation & corneal transplant. In the Required Request provision, the request for consent for eye donation is mandatory to be made to the next of kin when the death takes place & it has been found that if the request is made even with little motivation so least 10% of families are agreeable for consent for eye donation. In Mumbai alone, nearly 80000 to 90000 deaths take place every year & we can retrieve 10% cornea, the number would be 8000 to 9000 eye donations.
This is much larger than the present 1500 to 2000 eye donations received every year. In Presume Consent, unless there is a pre-recorded refusal, the cornea is allowed to be retrieved in all medico-legal cases where a post-mortem has to be performed. In Mumbai alone we have 7000 medico-legal cases where a post-mortem is required to be performed & even if we can retrieve 30 to 40% of cases, this also would go a long way & Bombay itself can become the hub for corneal transplant in Maharashtra.
In the USA, the Required Request Law is strictly enforced in every case of death and hospital authorities have to request and if the request is not made, there is a punitive punishment. Similarly, under Presumed Consent, the eyes are allowed to be retrieved in all post-mortem cases. It must be mentioned that the removal of eyes doesn’t affect post-mortem findings & also doesn’t disfigure the face. Both these are not possible for obvious reasons in other organs.
After our continuous representation & follow-up with good offices of Mr Desiraju who was the then Health Secretary, we could manage to overcome this hurdle & have trained technicians permitted to enucleate the eyes and from 2013 till now HOTA has amended and now it is THOTA. However, except for this amendment cornea is not clubbed with other organs & there is no provision of Required Request & Presumed Consent for eye donation.
Having proactive & favourable legislation would not only eradicate corneal blindness in our country but will also enable us to send corneas to several countries such as our neighbouring countries Bangladesh, Malaysia & several countries in Africa etc. where there is an acute shortage and will make India a leader in eye donation & corneal transplant in the world.