As a part of a research study on "Healthcare Regulations in Tamil Nadu", the Foundation for Sustainable Development at IIT (M) conducted a workshop on "Implementation of the Transplantation of Human Organs Act 1994: Challenges and Policy Options" at IIT (M) campus on 8 March 2003. Dr V R Muraleedharan, Professor of Economics at IIT (M) in collaboration with Dr Stephen Jan, Health Policy, unit of the London School of Hygiene and Tropical Medicine, UK. Conducted the workshop

The workshop was organized primarily to deliberate on the various challenges in the implementation of THOA and to explore policy options in regulating organ transplants in Tamil Nadu.

The workshop had a wide section of participants from the government, medical professionals from private health sector, social scientists, NGOs and media.

The workshop was broadly divided into two sessions. Session I was aimed at providing an overview of THOA and scenario of the organ transplants in India. This session was chaired by Dr Arjun Rajagopalan, Sundaram Medical Foundation, Chennai. The second session was a round table, chaired by Dr George Kurian, Christian Medical College, Vellore, to discuss the following questions:

(i) What are the immediate strategies that can be adopted to make the present legislation more effective?

(ii) What are the alternative policy options for regulating the organ transplants in India?

Session I commenced with an introduction by Prof. Muraleedharan. He elaborated the context of the study and why it was undertaken. He emphasized the various ways in which health sector regulations could affect the performance of the healthcare system.

He then presented the basic features of the THOA and pointed out several systemic weaknesses in the implementation of the Act. Some of the most widely accepted weaknesses with regard to Live-related donation are:

(i) Lack of provisions for counselling of the donors,

(ii) Lack of verification of addresses of donors and recipients,

(iii) Role of middlemen in coercing the poor to donate kidneys for payment,

(iv) Lack of protection of donors' health from pre- to-post –operation and

(v) Weak enforcing body in place to regulate organ market in India.

Dr Sumana Sundaram of MOHAN Foundation made a presentation on the basic concepts of transplantation and organ donation such as eyes, kidneys, lungs, etc. She emphasized the need to view "organ donation" as "gifting" and as a gracious act. She underlined the fact of under use of potential resources of organs (like from those who die from road accidents) and how it could be improved by making the different parts of the system work together through both organ-retrieval and organ-sharing mechanisms. She also highlighted the role of civil societies and independent bodies such as Multi Organ Harvesting Aid Network (MOHAN) Foundation, to harness the resources available for organ transplantation, outreach and education programmes.

Dr Sunil Shroff, urologist and founder of MOHAN foundation at Chennai made a presentation on the Indian and international experience in organ transplantation. He reiterated the aims of THOA and presented statistics on the distribution and the number of transplants conducted in India. He emphasized the relatively less number of cadaver transplants performed in India. It is an irony, he observed, that in countries like India where all major religions accept organ donation after death, the cadaver programme has not yet attracted the attention of policy makers. He also highlighted that even though the concept of brain death has been recognized under THOA, only a very small number of donations come from brain-dead persons. This is partly due to logistic issues and shortage of trained transplant coordinators, he explained. He emphasized a collaborative approach among private hospitals and between government hospitals in organ sharing, and dwelt on the possible role organizations such as MOHAN Foundation and FORTE (in Karnataka) could play to bring about desirable cooperation or collaboration among various hospitals.

Dr M K Mani, senior nephrologist, Apollo Hospitals, Chennai, spoke on the ethical issues in compensating organ donors. He emphatically stressed that payment for donors would (i)Tend to decrease the quality of organs retrieved for transplants (ii)Make the p00' sell their organs for a lower price and make them further economically weaker and (iii)Lead to exploitation of the poor and weaker section of the society by third parties having a vested interest.

 Dr Viroj Tangchoensathien and Rachata Tungsiripat of the International Health Policy Program, Thailand, made a presentation on their experience in Thailand on organ transplantation. They gave a comparative status between India and Thailand. The main difference was the provision of transplants from live unrelated donors in India, which is totally banned in Thailand. They pointed out that the major area of concern in India is the role of Authorization Committee, which approves unrelated donors, whereas in Thailand, the matter for concern was in defining the role of the coordinators in promoting the availability of organs from cadavers.

Dr Arjun Rajagopalan, Vascular Surgeon, Sundaram Medical Foundation, Chennai, who chaired the first session, concluded that Indian cultural beliefs are a barrier for improving cadaver donation and the mindset of the public has to change.

In Session II, participants deliberated on immediate strategies to make THOA more effective and policy options for regulating the organ transplants.

The Health Secretary and the Director of Medical Education, representing the Authorization committee, suggested few changes that could be brought about to make the present legislation more effective. These included decentralization of Authorization committee, making hospitals take some of the responsibility for ensuring proper enforcement of law and involving NGOs to verify donor-recipient relationships, addresses and counseling.

Dr Mani argued that the Act is unworkable because it cannot be policed. It is also bound to fail because it tries to balance the interest of different stakeholders. He suggested that the law should ban unrelated donors and encourage cadaver programmes. He emphasized that the government should allocate more funds to programmes that would help reduce diabetes, which is the major cause for kidney disease.

Prof. Keshav Rao, National Law School, Bangalore, brought to the notice of the audience that a petition is pending before the Supreme Court of India for quashing Section 9(3), which allows unrelated persons to donate their kidneys.

The other option suggested was the role of Appropriate Authority to keep hospitals performing transplants in check. This could mean restricting the number of transplants per hospital per month, which many argued as being unrealistic and arbitrary.

On the role of hospitals and doctors, many participants agreed that there was a need for greater use of ethics committees within hospitals, better information to be given relating to costs of post-operative care to the recipients, and greater compliance with the provisions of the Act by hospitals.

The last moot point was on improving cadaver donation in Tamil Nadu. A few participants were of the view that cadaver donation would not work due to: (i) lack of resources to enable pick up of road traffic accident victims who can be potential donors; and (ii) lack of critical care units in hospitals where deaths occur. The counterpoint put forward was that there are many brain-dead persons whose organs could be retrieved. Several participants explained their concern over the difficulties in getting certification of brain-dead persons. The reason for this lies in the current government policy which has empanelled only a few neurosurgeons or neuro-physicians working in government hospitals to authorize and give brain-dead certification. The p9.rticipants urged the government to authorize a wider pool of doctors including those in private sector to help increase the pool of organs from brain-dead persons and thus contribute to launching of a successful cadaver transplant programme in Tamil Nadu. A good cadaver transplant programme also has a number of prerequisites, one of which is the availability of a larger number of transplant coordinators. At present, the state of Tamil Nadu is woefully inadequate in the supply of transplant coordinators. Participants of the workshop urged the government to train more transplant coordinators and have a pro-active policy in developing cadaver transplant programme in the State. The workshop was concluded with a summary of the proceedings, presented by Dr Stephen Jan.

Acknowledgements:  We extend our special appreciation to Dr Suresh of Sundaram Medical Foundation and Dr Sunil Shroff of MOHAN Foundation for their inputs in organizing the workshop. We are also indebted to all participants for their valuable insights and suggestions.