Legislation and Government Policy

The Dynamics of Organ Transplantation: Why IMA must Step-Up

Dr. Sadhana Kala

Major problems in organ transplantation are not legal. Nevertheless, laws are needed to regulate the transplantation practice and to ensure that these follow the precepts morally, ethically and culturally acceptable to the society.

To the multitude facing death through organ failure, the organ substitution technology has come as a true gift of life. But the new technology has raised a number of questions to which there are no easy answers. Moreover, these questions relate more to ethics, morality and social norms rather than to the medical aspects of the new technology. As Ogburn (1922) has pointed out, new inventions and discoveries give rise to social and moral problems because social organisations and public norms and attitudes change at a pace much slower than that required by the new technology. And this gives rise to social and cultural maladjustments. As a major technology, organ transplantation may solve important health problems. But it has created unanticipated adjustment problems for the government, the general public, medical organisation and the patient and his family. New situations have arisen, both within the medical world and in the larger society, for which no clear norms or rules exist.

New medical technologies and therapies have become extremely expensive interventions which few individuals can afford and few hospitals can offer. Question has therefore arisen whether the society can afford to continue to develop such costly therapies. Cost has therefore become a very important factor in the decisions about the development and diffusion of new technologies like the organ transplantation. This article presents an overview of the medical aspects of organ transplantation; ethical and moral issues in the selection of organ recipients; the cost of the new technology to the individual and to the society; and the laws regulating the transplantation practices.

Medical Implication

Continuous improvements in medical technology — Surgical techniques, histocompatibility testing, typing reagents, crosshatching techniques, immunological conditioning with blood products, and most importantly, the development of immunosuppressive regimes – have revolutionized organ transplantations and have made it a worldwide practice. Kidney heart, liver, lung and pancreas transplantations are already being done, and transplantation of big intestine is foreseen in the near future. Moreover, the survival rate of transplant patients has increased dramatically: one-year patient survival rate for kidney transplant is 92-95%; for heart 75-85%; for liver, 65-70%; and for heart-lung : 50%.

Notwithstanding these successes, organ transplant is not a panacea. Besides the risk of organ rejection or failure, the patient is faced with recurrent infections and a lifetime compliance with treatment regimes. Immunosuppressive drugs have several side effects and global immunosuppression renders the patient vulnerable to infections. Several new drugs are now entering clinical trials and with these it will be possible to develop protocols tailored to individual patients and to specific situations. But problem of global immunosuppression and side effects remains. And although the dose of the drug may be tapered with time, withdrawal is not possible because it almost inevitably leads to graft rejection. The area where considerable research is needed is that of organ preservation. At present kidneys can be preserved for upto 48 hours, and even longer using a pulsatile perfusion apparatus. Liver and heart can only be stored in the cold. Liver preservation is limited to 8-10 hours and heart preservation is limited to 3-4 hours. There is a pressing need to extend the time of preservation so that the organs can be effectively distributed. India at present has a deceased donation rate of 0.05 to 0.08 per million population. We have still to find a solution to utilize the potentially large pool of trauma-related brain deaths for organ donation. Success of the therapy has brought forth problems and issues which were dormant when the technology was in the experimental stage. For example, patients who were earlier considered unsuitable for transplant, are now being included, and the number of patients awaiting organ transplant has been growing. The supply of organs has not increased at the same rate and thus the gap between demand and supply has steadily widened. Consequently, there has been considerable increase in the waiting period for the organs resulting in slow deterioration in the patient and thereby reduced chances of success of transplantation. In the US, for example, nearly 10% of the patients on the waiting list die for lack of organ supply, and only 60-70% of the waiting patients can be transplanted every year. Selection of recipients is therefore a major issue.

The Question of Recipients

It is not easy to decide who should get transplantation and who should not. The selection criteria have to meet the demands of medical suitability, ethical and moral acceptability, equity, fairness and justice, and cost effectiveness. In addition, to be credible, these criteria have to be open, and available for public scrutiny and debate. Several approaches have been suggested to resolve the ethical problems in organ allocation. Basically these approaches attempt to construct an ethical structure based on concepts such as rationing, distributive justice and value based system, and derive from these the distributive principles and finally the set of principles that will maximise the outcome. These concepts are then applied to the basic medical consideration to decide upon organ allocation.

The suggested ethical models are:

  • The medical model aims to maximizes life years.
  • The economic model aims to minimize cost per life year saved.
  • The economic and social model seeks the maximum rehabilitation potential.

Some of the basic medical considerations to which the above mentioned ethical concepts have to be applied are: Age, Potentially Recurrent Diseases, Re-transplantation, Noncompliant Behaviour Pattern, and Waiting Time. On a practical plane we are still left with the problem of how the scarce organs are to be allotted. Halasz has suggested that some proportion (50% or more) should be given to low risk individuals with long life expectancies, in whom minimum of complicating factors exist, and who therefore can be expected to have the greatest long-term benefit from transplantation; another proportion (perhaps 25%) could go to high risk recipients; including those with an urgent need; the remainder could be allocated to those not covered by these categories. The US formula for organ allocation assigns sixty-six percent weightage to medical benefits. Starze formula gives eighty percent weightage to equity. Veatch has proposed fifty-fifty compromise between efficiency and equity. It can be seen that despite a well-argued ethical structure, the practical formula for allocation of organs is difficult to work out.

Cost Conundrum

Even on purely medico-ethical considerations it is a difficult to determine who should have access to life prolonging procedure like transplantation. Once the cost factors are built-in, the task becomes even more difficult and complex. Costs are, nevertheless, too important a factor to be left out. A society has finite resources and therefore cannot do all that is possible. The scarce resources have to be carefully used to produce the maximum benefit for the society. Health care is not the only good in life, and resources have to be used to get other goods. Even within the health care sector, resources have to be distributed among various therapeutic procedure so as to produce maximum benefit for the society. Transplantation is a costly technology benefiting a relatively small number of people, at a very high cost to the society. How much the society should invest in such technologies, will therefore always generate a lively debate.

Legal and Regulatory Ramifications

Major problems in organ transplantation are not legal and thus neither are their solutions. Nevertheless, laws are needed to regulate the transplantation practice and to ensure that these follow the precepts morally, ethically and culturally acceptable to the society. In other words, these practices must be in consonance with the societal norms, although as brought out earlier, these norms themselves have to change to ensure optimal exploitation of the advanced technologies likes organ transplantation. As is to be expected definitive laws have been formulated in countries where organ transplantation has been an established practice for the past few decades: US, UK and many European countries.

In addition, WHO has proposed nine Guiding Principles for international use. In India, Transplantation of Human Organ Act (THO) was passed in 1994; and Transplantation of Human Organs and Tissues Rules in 2014. These are based on the concepts of the WHO’s nine guiding principles as well as a few concepts from the US and UK legislation. The nine guiding principles proposed by WHO are in some way or the other reflected in the laws of 41 countries around the world. Organ commerce is illegal and ethically abhorrent. Despite the THO legislation, the law-implementation is flawed and THO provisions are abused. Organ commerce and kidney scandals are often reported in the Indian media.

It is impossible for public policy, or law, to keep pace with the rapid advances in the medical technology. It is therefore incumbent upon the professional bodies like the Indian Medical Association and the Medical Council of India to come forward with codes and protocols to meet the challenges of new technologies. We can take the lead from the American Medical Association (AMA) of the US and the General Medical Council (GMC) of UK. Both of these bodies have been at the centre of all debates about new developments and have greatly contributed to, and influenced, the formulation of public policy. In our country, where the public’s and politician’s knowledge of medical matters is scanty at best, it is all the more necessary for the professional bodies to deeply involve themselves in public awareness and educational programmes, and in the public policy formulation debates. It is to be seen whether our doctors and professionals bodies will participate in the ensuing debates, or whether they will leave decisions in this important medical field entirely in the hands of ethicist, lawyers and politicians.

Dr. Sadhana Kala is the chief emeritus and senior surgical consultant at Moolchand Medcity, Delhi. She has formerly served as honorary consultant with Army, Navy and Airforce.

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