Organ Donation Guidelines

Context: In a first, the Union Ministry of Health & Family Welfare has issued a set of guidelines for the transportation of live human organs. The transport protocols aim to ensure the expeditious movement of life-saving organs from the point of harvest to their destination through effective use of available infrastructure.

UPSC Relevance:

Prelims, UPSC has been asking questions on treatment therapies and regulations.

Prelims 2021

In the context of hereditary diseases, consider the following statements:

1. Passing on mitochondrial diseases from parent to child can be prevented by mitochondrial

replacement therapy either before or after in vitro fertilization of the egg.

2. A child inherits mitochondrial diseases entirely from mother and not from father.

Which of the statements given above is/are correct?

a) 1 only

b) 2 only

c) Both 1 and 2

d) Neither 1 nor 2

Prelims 2022

In the context of vaccines manufactured to prevent COVID-19 pandemic, consider the following statements:

1. The Serum Institute of India produced COVID-19 vaccine named Covishield using mRNA platform.

2. Sputnik V vaccine is manufactured using a vector based platform.

3. COVAXIN is an inactivated pathogen based vaccine.

Which of the statements given above are correct? 

 (a) 1 and 2 only

 (b) 2 and 3 only

 (c) 1 and 3 only

 (d) 1, 2 and 3

NOTTO’s Advisory on Organ Transplants

The Advisory and its Purpose

• The National Organ and Tissue Transplant Organization (NOTTO) has issued an advisory to address a significant gender imbalance in organ transplantation.
• The advisory prioritizes women patients and relatives of deceased donors who are awaiting transplants.
• This is intended to correct a gender skew where women are more often donors than recipients.

Governing Law : The Transplantation of Human Organs and Tissues Act, 1994, allows harvesting of organs from living donors or brain-dead patients with the consent of family members. 

Evidence of Gender Disparity

• NOTTO’s Decadal Data (2013-2023):
  • In 2023, women constituted 63% of all living organ donors.
  • Despite this, women were a minority among transplant recipients:
    • Heart: 24%
    • Kidney: 37%
    • Liver: 30%
    • Pancreas: 26%
    • Lung: 47%
• British Medical Journal Analysis:
  • Over the past five years, women accounted for 36,038 of 56,509 living organ donations in India.
  • They only received transplants in 17,041 cases, highlighting a significant imbalance.

The latest guidelines

• The SOP (Standard Operating Procedure) will serve as a definitive guide for hospitals and states, covering various modes of transport, including road, air, metro, and water.
• A unique NOTTO-ID will be assigned to all organ transplant cases to enhance tracking and curb illegal trade.
• To prevent illicit organ trade, the guidelines strictly prohibit the transport of organs into or out of India.

Air Transport Guidelines

• The box containing the organ should be screened without opening it, but the accompanying staff must undergo standard security checks.
• Airport officials will create a “green path” from the ambulance to the aircraft, and from the aircraft to the destination ambulance, to ensure a clear and quick passage.
• The flight captain may request priority take-off and landing from Air Traffic Control and make an announcement about the organ on board.

Ground and Water Transport Guidelines

• A “green corridor” for road transport may be requested by the concerned authorities to ensure an uninterrupted journey.
• A “One Trigger System” will be used, where a request from an organ allocation authority (NOTTO/ROTTO/SOTTO) initiates the green corridor process, ensuring credibility and minimizing security concerns.
• Each state or city will appoint a police nodal officer to handle green corridor-related issues, such as jurisdiction and security approvals.
• Separate SOPs have been issued for the transfer of organs via railways and metro, as well as for transport by the Ministry of Defence personnel, detailing provisions for priority transit, accommodation, and security.

Potential Challenges and Concerns – highlighted in editorial

• Procedural problems : The current organ allocation protocols do not prioritize recipients based on anything other than health-related criteria. The new advisory would require a change to these established rules.
• Definition of “Near Relatives”: There is a lack of clarity on who qualifies as a “near relative” of a deceased donor and if the new rule would apply retroactively to all families who have donated organs since 1995.
• Fear of Misuse: There are concerns that this new system could be exploited as a “backdoor way” to facilitate out-of-turn allotments for non deserving patients by paying more money, especially given the ongoing issues with organ harvesting rackets.
• Balancing Principles: The primary concern for implementers is how to prioritize women without compromising the fundamental principle that the person with the greatest medical need should receive the organ.

The Way Forward 

• The advisory’s intent to address patriarchal norms and promote inclusivity is appreciable.
• NOTTO must ensure this is a “participative process” that involves all relevant agencies to address implementation concerns.
• It is crucial to adhere to the Transplantation of Human Organs Act while also working to widen access to the limited pool of organs.
• The paramount principle of not denying an organ to the person with the greatest medical need must always be maintained.

National Organ and Tissue Transplant Organization (NOTTO)

• It is a national-level organization under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. 
• It is the apex body for all activities related to organ and tissue donation and transplantation in the country.
• It was established as a result of the Transplantation of Human Organs (Amendment) Act, 2011.

Functions

• It also implements the National Organ Transplant Program (NOTP).
• Maintaining a National  Registry of data of organ donors and recipients across the country to ensure fair and equitable allocation.
• Acting as the central hub for all-India activities, connecting regional and state-level organizations (ROTTOs and SOTTOs) to facilitate the efficient procurement and distribution of organs and tissues.
• Developing and implementing policy guidelines and protocols for various aspects of organ and tissue donation and transplantation, including recent advisories to address gender disparity.
• Conducting campaigns and initiatives to create public awareness about organ donation and encourage people to pledge their organs after death.

Two of the Divisions

1. National Human Organ and Tissue Removal and Storage Network – It is the central networking agency responsible for coordinating the procurement, allocation, and distribution of organs and tissues at a national level. It also serves as the nodal agency for the Delhi and National Capital Region.
2. National Biomaterial Centre (National Tissue Bank) – It specifically focuses on the donation and banking of human tissues. Its main objective is to bridge the gap between the demand and supply of tissues like bone, skin, corneas, and heart valves, while also ensuring their quality and safety.