Complete organ transplant process in 6-8 weeks, says Delhi HC. What was the case?

What does the 1994 Act say?

The law governs the transplantation of human organs and tissues in India, including the donation of organs after death. It lays down regulations governing healthcare providers and hospitals, and stipulates penalties for violations.

A transplant can be either from a pool of organs of deceased persons donated by their relatives or from a living person who is known to the recipient.

In most cases, the Act allows living donations from close relatives such as parents, siblings, children, spouses, grandparents, and grandchildren. Altruistic donations from distant relatives, in-laws, or long-time friends are allowed after additional scrutiny to ensure there is no financial exchange.

Living donations from close relatives involving Indians or foreigners must be accompanied by documents establishing their identities, family trees, and pictures that prove the donor-recipient relationship. Donors and recipients are also interviewed.

Donations from unrelated persons require documents and photographic evidence to prove their long-term association or friendship with the recipient. These are examined by an external committee to prevent illegal dealings.

Offering to pay for organs or supplying them for payment; initiating, negotiating, or advertising such arrangements; looking for persons to supply organs; and abetting in preparing false documents can attract a jail term up to 10 years and a fine up to Rs 1 crore.

The Authorisation Committee plays a critical role in the transplantation process.

What is the Authorisation Committee?

The Authorisation Committee oversees and approves organ transplant procedures involving donors and recipients who are not near relatives. This approval is crucial, especially in cases where organs are donated for reasons of affection, attachment, or other special circumstances, to ensure ethical compliance and prevent illegal practices.

Section 9(4) says the “composition of the Authorisation Committee shall be such as may be prescribed by the Central Government from time to time”, and that state government and Union Territories “shall constitute…one or more Authorisation Committee consisting of such members as may be nominated by the State Government and the Union Territories…”

Under Section 9(5), the Committee is expected to conduct a thorough inquiry while reviewing applications for transplant approval. A crucial aspect of the inquiry is to verify the authenticity of the donor and recipient, and ensure that the donation is not driven by commercial motives.

Section 24 of the Act allows the Centre to make rules, subject to parliamentary approval, for carrying out the various purposes of the Act. These can relate to the manner and conditions under which a donor may authorise the removal of their organs before death, how a brain-stem death is to be certified, or the steps to be taken to preserve human organs removed from anyone, etc.

What do the 2014 Rules say?

Rule 7 of the 2014 Rules provides for the constitution of the Authorisation Committee and the nature of enquiry and evaluation conducted by it. Rule 7(3) says the Committee must ensure there is no commercial transaction involved in cases where the donor and recipient are not near relatives. But Rule 7(5) says that if a recipient is in a critical condition and needs transplantation within a week, the hospital can be approached for an expedited evaluation.

For living donor transplantations, Rule 10 describes the application process, which requires joint applications by the donor and recipient. Rule 21 requires the Committee to personally interview applicants and determine their eligibility to donate.

What was the case before the Delhi High Court?

The court ruled on a plea filed by a retired Indian Air Force officer diagnosed with kidney failure in 2017. By 2019, two hospitals had advised him to get a renal (kidney) transplant.

However, his application seeking approval for transplantation was rejected by the Army Hospital in New Delhi due to the non-availability of a “near relative” donor in terms of Section 2(i) and Section 9(1) of the 1994 Act.

Section 2(i) of the Act defines a “near relative” as a “spouse, son, daughter, father, mother, brother, sister, grandfather, grandmother, grandson or granddaughter”. Section 9(1) says that without the Committee’s prior approval, no human organ or tissue can be removed from a donor’s body before death and transplanted into a recipient unless the donor is a “near relative”.

After the petitioner was diagnosed with hypertension and chronic kidney failure at Sir Ganga Ram Hospital, the transplant was planned again. But no decision was taken — and in 2020, the petitioner approached the HC seeking the transplant and/ or a direction to the Committee to grant approval.

In February 2021, the HC directed the Authorisation Committee to decide the petitioner’s application within two weeks. But when the matter was heard again in October 2021, the court was informed that the petitioner had passed away.

What did the court decide, and why?

Despite the petitioner’s passing, the court proceeded with the case.

The Centre argued that the Committee took its decision within a week of receiving all documents, as prescribed by the 2014 Rules.

But counsel for petitioner contended there is no timeline for the Committee to conduct interviews, which leads to a delay in deciding cases. If the Committee indefinitely adjourns hearings without meeting donors, recipients, and their families, the applications remain undecided, causing prolonged suffering to the patients, the counsel submitted.

The court agreed, and ruled that everything from conducting interviews to processing forms and decision-making is to be done within fixed timelines, and not in an “expanded or elastic” manner. Such urgency is in fact, reflected in provisions like Rule 23(3), which requires a final decision to be taken within 24 hours of the meeting, the court said.

Despite this, the court found an absence of timelines under Rules 21 and 23 in holding pre-transplantation interviews by the Authorisation Committee, leading to delays. “In some cases, as in the present case, the recipient has in fact passed away awaiting the decision of the Authorisation Committee,” the court said in its order.

“The non-adherence to timelines has resulted in extended waiting periods of 2 to 3 years in some cases before a decision is made, which contradicts the intent as also the letter and spirit of the 1994 Act and the 2014 Rules,” the court said.

It suggested that after 4-6 weeks of receiving the application, the Committee can schedule interviews within 2 weeks, during which it will facilitate meetings of family members of the donors and recipients and conduct more than one interview.

However, the “entire process, from submission to decision, ought not to ideally exceed 6 to 8 weeks,” the court said.