This week, the government of Kerala announced its intention to implement mandatory requirement for brain death reporting in intensive care units of the state, de-linking it from organ donation. This was done in response to concerns raised by civil society organisations about the perception of selective brain-death declarations in order to facilitate removal and transplantation of organ to benefit a more affluent section of society who are treated in private hospitals.
This is not a new concern. Last month, an enquiry instituted by the Tamil Nadu government found that organs from deceased donors were being allocated preferentially to foreign nationals, especially those from the Middle East, Central Asian republics and Africa.
Especially concerning is the data on lungs and hearts: 25-33% of such organs are routinely given to foreign nationals. The reasons put forward are exhaustion of Indians on the wait list, medical non-fitness of listed Indian recipients, or refusal because a certain surgeon was not available. A desktop search quickly brings to notice other such instances, in fact transplanting a foreign national was even reported as some sort of achievement.
These incidents remind me of a four-year-old email exchange with a heart transplant surgeon from Israel who wanted to find out whether hospitals in Chennai were systematically offering organs to foreign nationals. He shared with me a letter written by the international patient office of one such hospital to the Indian Embassy in Tel Aviv for the grant of a visa. Since Israeli nationals must seek approval from the Israeli Sick Fund in order to be eligible for reimbursement, the Fund wanted to know the legitimacy of this process. In my naïveté, I told him I found this possibility highly unlikely, made enquiries from the officers of the hospital, and was reassured that the hospitals were following the relevant Indian laws.
The letter, however, was real. That was a time when Tamil Nadu was receiving a lot of justifiable kudos for boosting deceased organ donation. Raising disconcerting issues was considered unjustified, attacks on an efficient system, and even anti-progress.
Since then, however, it has become clear that this system favours the well-off. Other events have boosted this perception. For example, the husband of V.K. Sasikala, considered very close to late chief minister Jayalalithaa, received a liver and kidney from a deceased donor who was mysteriously flown from Thanjavur to Chennai. It was widely reported at that time that there was no way the donor, a poor flex board printer, would have been able to afford the cost of being airlifted.
Colleagues in Tamil Nadu admit in private conversations that by no means was this an isolated instance. Even in the case of the recent Tamil Nadu enquiry, it took the Kerala chief minister to raise the issue of transplantation of organs to foreign nationals with Tamil Nadu government.
Allocating organs to foreign nationals has been justified on the grounds that since suitable Indian recipients are not available, these organs would have been ‘wasted’, and that this is in the spirit of promoting ‘medical tourism’ in India. These arguments are flawed at many levels, and indicate a fraud on the Indian deceased donation system.
Anyone who knows anything about deceased donation knows that it is impossible for the potential recipient to know when a matching organ might become available. When an organ does turn up, the suitable recipient needs to be identified, and the transplantation completed within a few hours. So how is it that foreign nationals with advanced end-stage heart and lung disease who require expensive medical care are lying around several thousand miles from home in India unless they have a reasonable expectation that they will be getting an organ? More so, that expectation would extend to there being no suitable Indian national recipients.
As to the issue of tourism, let us not kid ourselves, these recipients are not coming to India with the expectation of getting high quality medical care. Their sole purpose is to get scarce organs which they will not get in their own countries. This is predatory behaviour, and the textbook definition of ‘transplant tourism’, which has been denounced as unethical by influential voices such as the World Health Organization, the Declaration of Istanbul and the Madrid Resolution.
Deceased donation, in its current form, is exacerbating inequities in access to this precious resource. An argument is that “at least some are benefitting”. Indeed, that is true – but if we continue to ignore the issue of inequity, what happens to the ones Adam Smith called ‘invisible’ and Yuval Noah Harari considers at risk of becoming ‘irrelevant’? The cases that have come to light so far show that the poor are increasingly at risk of becoming the provider of organs to well-off Indians and foreigners.
The only solution to this is for the state to support the development of organ transplantation services in public hospitals that ordinary Indians go to. Only this will reduce the sense of public disenchantment and restore trust in the sanctity of the process of organ retrieval and allocation.
Indeed, we should ask – should organs from Indian donors should go to foreigners at all? The reason countries invest resource in developing a deceased donation program is to address the unmet need of organs to their own citizens with end-stage organ failure. Organs from altruistic deceased donors are national resource and should not be used to service foreign citizens when hundreds of thousands of Indians are dying of organ failure. It is ludicrous to claim that in a country of 1.3 billion there are no suitable Indians on a transplant wait list.
Even for living donor transplants, the Indian Human Transplant Act Rules have set the bar much lower for foreign nationals. The law permits only altruistic donation, which in an overwhelming majority is from a family member. Indian citizens have to (quite appropriately) go through a rigorous process of establishing the relationship, which involves genetic testing not only of donor and recipient, but often of other family members. All this is scrutinised by the authorisation committees.
In the case of donor-recipient pair of foreign nationality, all that is needed is a letter from an embassy official certifying the relationship. Since this is all that the rules require, the authorisation committees are happy to let the transplant proceed. It is common knowledge in the transplant community that these letters are a joke, and indeed most such transplants are from unrelated donors and involve commercial transactions. I should point out that not all private hospitals bypass their protocols for establishing genetic relationships – and as a result do not transplant foreign nationals in any meaningful numbers.
Any organised system of organ distribution and allocation needs a supervisory mechanism. The National Organ and Tissue Transplant Organization (NOTTO) was set up to develop, implement and monitor a framework for country-wide organ sharing through development of a common waitlist and regional co-operation. Many states have developed their own organ sharing networks and the degree of their integration with the National networks is unclear to say the least. It is expected that these organisations will talk to each other, act as gatekeepers of the system and as advocates for equitable organ distribution to Indian citizens.
According to reports, the head of NOTTO expressed reservations about the organ allocation policies in Tamil Nadu that discriminated in favour of the foreign recipients. The current Member-Secretary of the Transplant Authority of Tamil Nadu says the Authority has no say in the selection of recipient, and it is the hospital that identifies the recipient. This is in violation of the principle of transparency and organ allocation. Organs should go the persons on top of the wait-list identified on the basis of objective criteria, irrespective of which hospitals they are registered at!
Coming back to the current notification of the Government of Kerala, the requirement to identify brain deaths is already part of the 2014 Transplant Rules. Organ Retrieval Hospitals must have qualified transplant coordinators AND count and report all brain deaths in ICUs. However, this rule is almost never followed.
The World Health Organization has been long concerned with ensuring the ethical use of organs and tissues around the world. The objectives set in the 2010 Resolution of the 63rd World Health Assembly (WHA), of which India is a signatory state, included the following –
- to promote a system of transparent and equitable allocation of organs, guided by clinical criteria and ethical norms, as well as equitable access to transplantation services in accordance with national capacities, which provides the foundation for public support of voluntary donation;
- to strengthen national and multinational authorities to provide oversight, organisation and coordination of donation and transplantation activities, with special attention to maximising donation from deceased donors and to protecting the health and welfare of living donors with appropriate health-care services and long-term follow up;
- to collaborate in collecting data including adverse events and reactions on the practices, safety, quality, efficacy, epidemiology and ethics of donation and transplantation.
In the same year, a joint meeting between the WHO and the European Union that was attended by 140 representatives of international scientific and medical bodies, government officials (including India) and ethicists adopted the principle of National Self-sufficiency in transplantation. According to this resolution, nations have a responsibility to address the organ transplantation needs of its citizens. Organ sharing between countries is acceptable only in the context of regional cooperation, in which citizens of participating countries have equal rights on shared resources, not where one country is a unilateral supplier of organs.
At the 70th World Health Assembly of 2017, the WHO established an Organ Donation and Transplantation Task Force to implement the WHO Guiding Principles in member states with organ transplantation services. A major goal of the task force is to improve access to national transplant programs in an ethical and regulated manner and to establish a global governance for efficient coordination of global efforts in combatting organ trafficking.
The task for NOTTO is cut out. Its primary responsibility, in collaboration with the state organ procurement organisations, should be putting in place a robust mechanism for collecting data from procurement hospitals on the number of those declared brain-dead, number of families approached to discuss donation opportunities, number and type of deceased donor organ transplants, relationship of each living donor to the transplant recipient – including the country of residence of the donor – record outcomes following transplantation for each recipient, and a follow up of the living donor.
Remarkably, all these are already part of the Indian Human Organ Transplant Act, have already been notified by several states but have completely been ignored by the organ procurement organisations.
It is time our professional community, and the central and state governments recognise their moral, ethical and statutory responsibilities and make sure that the organ procurement and distribution system fulfils its responsibilities towards Indian citizens, with special attention to the hitherto disenfranchised.
Vivekanand Jha is the Executive Director of George Institute for Global Health India, Professor of Nephrology at the University of Oxford; President-Elect, International Society of Nephrology and Member of the WHO Task Force on Donation and Transplantation of Human Organs and Tissues