Reforming Organ Transplantation

• 15 Jan 2024

For Prelims: Transplantation of Human Organs Act, 1994, National Organ Transplantation Guidelines, National Organ and Tissue Transplant Organisation (NOTTO)

For Mains: Organ Donation and Transplantation – related ethical concerns, Emerging Issues in Organ Transplantation.

Source: IE

Why in News?

Recently, the Delhi High Court has recommended an optimal timeframe of 6-8 weeks for completing organ transplant processes involving living donors.

• High Court directed the government to establish specific timelines for all stages of organ donation applications in accordance with The Transplantation of Human Organs and Tissues (THOT ) Act, 1994, and Transplantation of Human Organs and Tissues Rules, 2014 (THOT Rules).

What Does the THOT Act, 1994 Say?

• About:
  • 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.
• Organ Donors and Recipients:
  • 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.
• Donations From Distant Relatives and Foreigners:
  • 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:
  • 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.
• Fines and Punishments:
  • 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.
• Formation of NOTTO:
  • National Organ and Tissue Transplant Organization (NOTTO) is a National level organization set up under Directorate General of Health Services, Ministry of Health and Family.
    • This has been mandated as per the Transplantation of Human Organs (Amendment) Act 2011.
    • National Network division of NOTTO would function as apex centre for All India activities of coordination and networking for procurement and distribution of Organs and Tissues and registry of Organs and Tissues Donation and Transplantation in the country.

What Do the THOT Rules, 2014 Say?

• Authorisation Committee:
  • 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.
    • 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.
• Living Donor Transplantations:
  • 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 is the Authorisation Committee?

• About:
  • 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.
• Composition:
  • Section 9(4) of the Act,1994 says the “composition of the Authorisation Committee shall be such as may be prescribed by the Central Government from time to time”.
  • 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.”
• Powers:
  • 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.
• Role of Parliament:
  • 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.
    • Also how a brain-stem death is to be certified, or the steps to be taken to preserve human organs removed from anyone, etc.

What did the High Court Decide?

• Constitution of Authorisation Committees
  • The Act mandates state governments/Union Territories to form one or more authorisation committees, consisting of nominated members.
  • High Court underscores the necessity of it to maintain the integrity and effectiveness of organ transplantation protocols.
• Timelines for Living Donor Transplantation Application:
  • The high court stipulates that the timeline for processing living donor transplantation applications should not exceed a maximum of 10 days from the date of application.
  • Within a maximum of 14 days, the court mandates the verification of documents concerning the domicile status of the recipient and donor.
  • Any opportunity given to the donor or recipient to complete required documentation must be communicated within the prescribed timeline under the Rules.
• Scheduled Interviews and Family Meetings
  • After four to six weeks of receiving the application, interviews should be scheduled within two weeks.
  • The committee should conduct the interview, facilitate a family meeting, and convey the decision within this timeframe.
    • The court emphasizes that the entire process, from submission to decision, should ideally not exceed six to eight weeks.
• Recommendations to Government:
  • The high court calls for the judgment to be presented to the Secretary, Ministry of Health and Family Welfare, ensuring the prescription of timelines for all steps in the consideration of organ donation applications, after consulting relevant stakeholders.