Brain death and organ donation in India

Abstract

The concept and understanding of brain death was first accepted after the Sydney Declaration in 1968[1] and many countries started their programme from the early seventies by setting the legal framework necessary to establish brain death, followed by organ donation. In India, the Transplantation of Human Organs Act (THOA) 1994 and the subsequent amendments in 2011 and rules in 2014 form the legislative foundation for brain death and organ donation.[2] This act established a transparent and robust system to support the much-needed cause of organ transplantation in India. Despite this, the desired response to the THOA was not noticed until the mid-2000s when organ transplantation extended from being limited to kidneys, to other organs such as liver and later the heart. The main quest was to bridge the gap between the organs available and organs needed. A country with a population of over a billion was obviously grappling as there was an increased need for organ transplantation but the donors were not available. Expertise and technology had matured, both in the public and the private healthcare sectors, to facilitate organ transplantation but was not able to function fully due to lack of brainstem death donors. While a lot of effort was put into raising awareness by a number of non-governmental organisations, like MOHAN foundation, and advocacy of several individuals, the much-needed boost came in the form of concrete steps taken by state governments such as Tamil Nadu[3 4] and later emulated by Maharashtra, Karnataka, Kerala and others. The states adopted the programme as a mission and made several provisions for its smooth implementation. The media contributed by widely reporting on populist topics such as heart transplant, green corridor formations, transplant success stories and by lauding the donor and their families for their contribution in grief. The National Organ and Tissue Transplant Organisation was established with an aim to oversee the entire programme under the leadership of the Ministry of Health, government of India. The much-needed impetus for the success of any programme only comes when the apex management pushes for it. India suddenly saw a rapid growth in the organ donation rates going from a dismal 0.05 per million populations to 0.8 per million populations in a span of few years. Though the donation rates seem minuscule compared to some of the countries in the world like Spain, where the donation rate is 35 per million population, the trend is encouraging. After more than two decades, the long process finally seems to be bearing its results. However, it has brought its own set of unique problems. The most important being acceptance of brain death by the nation's own medical fraternity, due to the often construed perceptions of law and ethics.[5] Conflicts of interest seem to be one of the most difficult barriers to cross and have only begun to be resolved when doctors from intensive care, anaesthesia and other neutral specialities started contributing towards the programme.[6] The inclusion of these neutral stakeholders has helped to address these ethical dilemmas. The parallel introduction of trained transplant coordinators in transplant centres across the country also provided a major push in improving the consent for donation. The donor families accepted transplant coordinators perhaps finding it easier to discuss and express their thoughts compared to doctors. Countries such as Spain, Australia and the United Kingdom are a step ahead and have introduced ‘Donation Physicians’ along with the transplant coordinators.[7] Perhaps, this would be one of the many reforms India may have to take if the cadaver donation rates are to be improved to levels matching some of the better performing countries in world. India has an Opt-in system (consent for donation is required) as opposed to Opt-out system (implied consent),[8] and the question of refusal of donation by the next of kin after brain death diagnosis is often the biggest hindrance in pushing this programme further. With the legal framework of brain death being accepted only in the context of organ donation, there is an apprehension to proceed with the declaration, though states have made declaration mandatory. This has led to doctors sometimes shying away from declaring brain death if they perceive that consent for donation would not be there. This can best be addressed by bringing in Uniform Declaration of Death, where brain death is included in the Registration of Birth and Death 1969 Act of the Government of India.[9] The simple inclusion in this Act will support doctors to declare brain death and be legally empowered to withdraw supports if there is no consent for organ donation following brain death. Many have argued this to be another misconceived interpretation of law by doctors, but the fact remains that even the legal community have identified this to be a lacuna which needs to be clearly defined. Numerous efforts have been made to improve the awareness of this programme to the general population, with an aim to achieve increased donation rates. However, the sacrosanct ethical and legal principle of segregating the donor and recipient information is often breached unintentionally due to the hype and associated publicity surrounding each donation. Many trust this to be a part of developing phase of Brain Death Organ Donation programme, anticipating that the kind of publicity that impairs confidentiality will dissipate as the programme matures and transplantation becomes more common. Its effects can be long lasting and may pose ethical and legal challenges if not controlled early.[10] Transplantation has often been considered to be the epitome of clinical excellence and maturity of a healthcare delivery system. While this is largely true in state-driven healthcare system such as Australia and Canada, the same cannot be enunciated for Indian healthcare system, which is predominantly privately dominated and has a large disparity in delivery of care. While the country is certainly progressing in brain death declarations, organ donation and transplantation, it is important to remember that organ donation is a by-product of good trauma care and good intensive care. If we continue to push the boundaries for trauma and intensive care improvement and standardisation across the country, we will indirectly be creating a bigger pool of potential donors in our hospitals. Currently, India has around 140,000 road fatalities.[11] It would be reasonable to assume that if trauma services and intensive care services are improved across the nation, then many of these patients would make it to the hospital, of which some may progress to become brain dead despite maximal efforts. Investment in trauma and intensive care services would also lead to better donor and recipient management. The perception towards the whole programme will likely improve because families who feel more satisfied and appreciative of the level of care received by their loved ones may be more forthcoming in consenting for organ donation where the outcome is ultimately brain death despite the best efforts of medical staff. Regardless of the problems, the programme has definitely prompted the medical, legal and political establishment to think of improvement. In days to come, all of these objectives will be addressed in some forum or other and fortunately the only way is forward. New legislation may be implemented, and processes may be established–it is important to be aware that India is poised towards a huge medical revolution. Prudent policy and management going forward may see us complementing other more mature healthcare systems.