India: Legal Aspects Of Organ Transplants

Rapid advances in the field of organ transplantation technology have resulted in widening the existing gap between supply and demand of organs, raising numerous moral and policy questions. Within 30 years, renal transplantation has progressed from an unsuccessful experimental procedure to a widespread and routine procedure, covering an estimated 35,000 patients each year. In fact, thanks to the success of organ transplantation technology, we are now faced with the challenge of donor shortage and possible commercialisation of supply, which is generally viewed as inconsistent with accepted norms of public policy. Therefore, on July 8, 1994, the President of India assented to the Transplantation of Human Organs Act (Act No.42, 1994) providing for "the regulation of removal, storage and transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs and for matters connected therewith or incidental thereto". As a result, various state legislatures prohibited all organ sales.

However, this may have been a hasty and inappropriate measure and the Act's provisions may suffer for want of a well-founded jurisprudential base. It is likely that it represents a knee-jerk reaction, and which may have adverse effects on society as a whole. While it cannot be denied that certain provisions of the Act stand on sound reasoning and principles of law, medicine and ethics, to lose sight of the reality while enacting such a law is indefensible.

The principal objection pertains to the imposition of a complete prohibition on the sale of organs. The Act's preamble envisages the object of the legislation in a two-fold manner:

• (1) Providing for regulation of removal, storage and transplantation of human organs for therapeutic purposes; and
• (2) prevention of commercial dealings in human organs.

The Act necessitates that the donor must not be below 18 years of age, must agree voluntarily to his organ removal, and that his consent is informed. It further prohibits removal of organs by anyone other than a registered medical practitioner, and the transplantation must take place in a registered hospital.

Further, to prevent commercialisation of sales of human organs, Sections 18 & 19 criminalises such transactions, including supply of organs for payment, and making/receiving any such payment. Payment, however, does not include reimbursement for the cost of removing, transporting or preserving the organ to be supplied or any expenses/loss of earnings incurred by the donor which can be attributed to his supplying any organ from his body.

Section 9(1) provides that no human organ shall be removed and transplanted unless the donor is a close relative as defined in section 2(i) of the Act. And though an altruistic donor is permitted to donate organs, it is only with prior authorisation of the committee constituted under the Act. Section 9(5) & (6) lay down the procedure to be followed while obtaining the committee's approval.

However, though the Act contains elaborate provisions regulating organ transplantation, realistically speaking, there are a number of incentives that work against the efficacy of a voluntary policy in obtaining cadaver organs. The highly emotional circumstances under which such requests are made make it uncomfortable for both families and medical personnel to communicate on the subject.

Critiquing The Act

I. While altruistic transfers are allowed, the sale of organs is criminal. Such a distinction is devoid of any logic. Firstly, where the risk factor is concerned, as per medical literature, there is no great disability in losing one kidney, the total risk to the donor being 0.12%. Hence, if the risk from kidney donation is minimal, risk, as a reason for prohibiting donation for money, cannot be logically pleaded. Even if a risk does exist, what is the moral difference between that risk and accepting high wages for a risky job.

II. The distinction (between sale and donation) is sought to be justified on grounds of free will. Consent cannot be voluntary and unfettered against a background of poverty and potential reward. But it is arguable that the moral persuasion innate in a donation within the family is possibly greater than any financial coercion exerted by market forces in a commercial set-up.

III. The Act disallows a minor from being a donor. The principle that a minor is incapable of being subject to a procedure not to his advantage is not absolute . Therefore, it is always possible that a court might consider that an organ donation is also in the interest of the minor donor, who is usually a sibling of the recipient.

IV. Under section 9(6), the Act fails to prescribe any time limit within which the authorisation committee must communicate its decision on the application for transplantation. In Paramanand Katara v. Union of India case, it was observed that no law can intervene to avoid/delay the discharge of the obligation of the medical practitioner. Therefore, laws of procedure, whether in statutes or otherwise, which would interfere with the discharge of this obligation, cannot be sustained and must give way. Thus the mechanism provided under Section 9 in the form of restrictions on removal/transplantation of organs, where the donor is not a near relative of the recipient, is likely to fail the Katara test in cases of emergency where the recipient's status is critical. The definition of near relative is also susceptible to criticism as it is narrow when compared to counterparts in other countries.

One cannot but help notice that Section 2(i) read with section 9 is unreasonable as it applies unequally to patients who need a transplant. Thus a potential recipient without any near relatives is at the mercy of an altruistic donor and the approval of the authorisation committee. Also, it is possible that none of his/her relatives are fit in the medical sense to be donors.

In Search Of A Viable Alternative

Under the present circumstances, it is felt that it would be wiser if there is an option for a regulated commercial market for organs, rather than complete prohibition. A commercial market could be regulated by forbidding organ-brokering by third parties and allowing direct sale between the donor and recipient, allowing sale of cadaveric organs providing cash incentives for the donor like free life insurance, and allowing purchase of organs from a family member. The government could also take steps to develop an altruistic donor network.

The question we are faced with today is whether more efficient organ procurement is the long-term solution. The answer is sadly no until and unless India follows a cadaver donation programme, which is missing thanks to the lack of facilities for the resuscitation of the victim at the accident spot, ill-equipped hospitals, shortage of trained personnel, lack of proper transport facilities, etc.

Thus it is essential that scientific and technical aspects of cadaveric transplantation are developed to fill the current void, coupled with the widely accepted method of Presumed Consent, which is a frequently employed method of procurement in some countries. Under this system, the state presumes that the donor wishes to donate organs, unless indicated otherwise during life. When strictly followed, it has proven to be the best method of maximising organ procurement.

The writers are students at ILS Law College, Pune.

Copyright © 2002 Indian Express Newspapers (Bombay) Ltd.

This article posted March 12, 2003.