India conducts the 2nd highest number of organ transplants in the world . While this is impressive, most of these transplants are living donor liver and kidney transplants and a smaller proportion are deceased donor (cadaveric) transplants. While organ donations and transplants have increased over the years, they are far behind what is needed to save thousands of patients suffering from organ failure. The organ donation rate in India is below 1 per million population. Shortage of organs for transplantation plagues not only India, but the entire globe and some successful strategies from other countries may be relevant for implementation in India too.
The Transplantation of Humans Organs & Tissues Act (THOA) enacted in 1994 and amended in 2011 has been largely very successful in curbing illegal organ trade and enabling deceased donor transplants. The Act recognized brain death as legally acceptable and outlined procedures and protocols for its declaration. This enabled organ donation after brain death (deceased or cadaveric organ donation). Illegal organ trade was curbed by regulating transplant hospitals and imposing penalties for violations. This well framed and written Act has also been effectively implemented and has largely been successful in achieving its goals, although there are rare occurrences of wrongdoings.
There are however certain areas of the law, if amended, can go a long way in increasing the rate of deceased organ donation in India.
Single Implementation and Regulatory Authority: The regulatory framework under the current Act consists of 3 enforcement agencies. The Appropriate Authority (generally the Director of Health Services of the state) grants the licence for transplant to various hospitals. Organs from deceased donors are allocated by the NOTTO / ROTTO / SOTTO network either directly or through an independent organisation. Living donations are approved by hospital or state level Authorization Committees.
Out of all these only the Appropriate Authority has powers of a civil court, whose decisions need to be ratified by formal courts in case of criminal offences. In case of any violations in living donor transplant (such as fake documents presented to the Authorization Committee) and in deceased donor registration and allocation, both the relevant agencies do not have the power to penalise patients or the hospital, making it difficult for them to implement the policies. Even the Appropriate Authority has often not exercised their powers except for suspension of a hospital’s licence in a few cases.
It may be easier to regulate transplant activity by a single regulatory authority. Effectively implementing the National Organ Transplant Program (NOTP) including registration of transplant hospitals, organ allocation, living donation approval, monitoring transplant activity and outcomes with a registry and mass awareness campaigns and budgeting may be easier with a single agency.
Uniform Definition of Death and Delinking Brain Death from Organ Donation: Almost all deceased organ donations in India take place after Brain-Death. The process for this is clearly defined in the law.
One of the main problems faced by ICU doctors is that brain death is defined in the Transplantation of Human Organs Act, 1994 (THOA) and is different from The Registration of Births and Deaths Act, 1969 (RBDA) and The Indian Penal Code, 1862 (IPC) (Section 46).
Therefore, if a brain-dead person’s family does not wish for organ donation, the following happens: ICU doctors are not able to declare the person’s death, issue a death certificate, and stop life support such as ventilators. This leads to unnecessary, futile, and expensive ICU care for the brain-dead person, blocks an ICU bed, and leads to confusion in patient’s families’ minds and conflicts between doctors/hospitals and families.
Kerala was the first State to delink brain death and organ donation, clarifying that all treatment, including cardio-respiratory support can be discontinued after brain death (GO 7/2020/H&FWD). This withdrawal of support if the family is not interested in organ donation, should be specifically mentioned in the law to avoid any delays and unpleasantness. Therefore, brain death should be delinked from organ donation and the same definition of death should be used in all 3 laws. The same was done in the USA in 1981 by passing the Uniform Declaration of Death Act (UDDA) and in other countries.
Mandatory Declaration of Brain Death and Expanding Procedures: The amended law mandates the treating medical team of the brain-dead individual to request for organ donation. This is called a Mandatory Required Request. However, it does not enforce brain death declaration, which would be a welcome addition in THOA to increase organ donations, as has been successfully done in Tamil Nadu via state government orders (GO 6, GO 75, GO 287) and in other States as well. Furthermore, the role of ancillary tests in brain death certification, especially in situations such as those paediatric donors and those where an apnea test is not possible, also needs clarification.
NTORCs: The concept of Non-Transplant Organ Retrieval Centers (NTORC), where brain death declarations and retrieval can be done, has also not been very successful, because of the requirement for these smaller centres to apply/register as NTORC and have a medical board for certification of brain death.
Most small hospitals may also not have specialists required for brain death certification and organ retrieval. While voluntary registration by the hospitals would have been ideal, an alternative could be to consider all hospitals with appropriate (defined) facilities deemed NTORCs. External medical boards and retrieval teams from established transplant centres (in place of their own) could be allowed to certify brain death and retrieve organs in NTORCs. Such centres could also be supported by grants and reimbursed costs incurred in donor maintenance/organ retrieval. This will also address the current practice of shifting donors from non-registered hospitals to transplant centres (to make them in-house) and allow a fair and equitable allocation of organs from such donors.
Provisions for Donation after Circulatory Determination of Death (DCDD): Currently, most deceased donor transplants performed in India are from brain dead donors. However, the actual number of donations are still very small, as only about 2% of deaths are due to brain death. Organ donation can also be done after circulatory death, called Donation after Circulatory Death (DCD) or donation after death by circulatory criteria (DCDD). In the past the results of transplants from DCD organs were inferior to organ donations after brain death. However, two technologies i.e. NRP (normothermic regional perfusion) and ex-vivo hypothermic and normothermic organ perfusion have improved their success rates of DCD transplants. Transplants from DCD organs have significantly increased the number of transplants in many European countries and USA in the last 10 years.
DCD donation will also substantially increase organ donation in India, as most people are more familiar with the concept of death after heart stopping. To enable this, the process for determination of futility of care should be outlined, families of persons with terminal illness wishing for Do Not Attempt Resuscitation (DNAR) should be able to consent for organ donation after death.
Unused Organs for Research: Currently THOA only allows organ retrieval for therapeutic purposes. Organs that have been found unsuitable for transplant after retrieval could be allowed for research.
Recognise & Support the Family of Organ Donors: Families of all organ donors could be honoured by state/public recognition in media. This will help increase acceptance of organ donation. If the primary earning member of the family is an organ donor, the family may be supported by National or respective State Governments by offering them education for a child in the family, a government job for the next of kin, health insurance or others.
Privacy: Privacy is a delicate issue. Current practice is to not reveal identities of the donor and the recipient to each other. However, their privacy is often violated by articles in the media in any case. While some donor families may not want to know the identity of the recipient, there are many who do. If the same is allowed after the transplant in cases where the donor and the recipient agree to it, it would help donor families recover emotionally from their loss by witnessing success of transplants in recipients. However, this is an issue that has to be thoroughly evaluated before introducing it into law.
Expedited Permission for Emergency Living Donor (liver) Transplants: The process of approval form the Authorization Committee may be time consuming, especially if there is no hospital based Local Authorization Committee. The process for such situations could be expedited with a provision to submit documents in retrospect. This situation is not rare in liver transplant and currently requires an emergency Authorization Committee meeting at odd hours.
These amendments to the existing law will help all stakeholders to work seamlessly thereby increasing the rate of organ donations in India, thus saving thousands of more lives.