The Ministry of Health after almost two and half years has finally got round to notifying the new rules on how to implement the Transplantation of Human Organ Act. The new act after doing the rounds of the Rajya Sabha and Lok Sabha was signed and passed by the President of India in Sept 2011. However the act and rules still need to be passed by the state health assemblies before they can become universally applicable in the country.
There are two aspects that the rules have looked at – one is to ensure that the commercial angle to organ donation is curtailed in India and second is to promote after brain death. On briefly looking though the 35 odd page document Medindia editors made the following conclusion-
a. A few sections of the rules are confusing and the clauses are too wordy and unnecessarily lengthy. Some people will need a lawyer to get the right interpretation.
b. However a few sections were a bit of surprise and have gone further than expected to help the organ donation programme move forward
The progressive sections of the Rules include- -
a. Deceased Donor maintenance costs have been clearly defined.
b. While organ retrieval requires registration of a hospital but ‘Tissue Retrieval’ requires no registration. This should help Eyes and skin donations.
c. During organ retrieval in brain death situation, post-mortem doctor to be present in operation theatre. This should help hasten the process of donation and avoid delays in handing over the bodies to the relatives
d. Requirement of Transplant coordinator to give hospital a license for undertaking transplantation – this aspect will help in counselling of families for taking consent for organ donation where there is a brain death donor.
e. More authorisation committees to be formed and its format has been laid down – this will avoid delays in getting approval in case of living donations.
f. Certification of brain death possible by Intensive care doctors and anaesthetists – this will ease the pressure from Neurologists and improve certification rates and hence improve donor pool.
g. Required request for donation a must in case brain death declared – this will ensure that the relatives are empowered with the knowledge that organ donation donation is possible if brain death occurs in their loved ones.
i. Tissue donation will not need a doctor –a trained technician should be able to undertake the procedure – this rule will ease improve donation rate and will, the pressure from doctors. However the hospitals will need to ensure that the technicians are well trained before they are made to do such retrieval of tissues.
Some sections of the rules are ambiguous and leave much to be desired and have not been fully discussed to look at the pros and cons in implementing these rules. Example are -
a. Value of Donor Registry – even if we have such registry permission of relatives will still be required to proceed for donation. If a donor signs Form 7 and gives consent to donate after death and the relatives say no, there is no provision to donate.
b. The rules have stated that the organ recipient registry where organs originate from deceased donors, priority should be given to recipients where a living donor refuses to donate. This is absurd and will discourage living donations including swap donations.
There are also too many form governing in the new rules, twenty one to be precise. It will be interesting to see how many states take up the new law and rules and the time scale in which the states adopt the new law in the field of organ donation and transplantation.