The Legal Framework

ORGAN DONATION: THE LEGAL FRAMEWORK

Bridging the Demand and Supply Gap

Swapna Jha*

The significant demand-supply gap in organ donation in India presents a critical healthcare challenge, as over 200,000 individuals require transplants annually, yet only a fraction receive the organs they need. The disparity is particularly glaring for kidney transplants, where about 180,000 patients are on waiting lists, but only 17,000-18,000 surgeries take place each year. Similar shortages exist for other organs, such as the liver, heart and cornea.

This imbalance is exacerbated by several barriers. Low awareness about organ donation, pervasive misconceptions and cultural or religious hesitations contribute to a limited donor pool. Many lack information about the process and impact of organ donation. Fears or myths also often discourage potential donors and their families. Additionally, societal norms and superstitions can impede acceptance of the idea.

Addressing these issues requires sustained efforts to educate the public, dispel myths and encourage organ donation. Public awareness campaigns, educational initiatives in schools and communities and collaborations with religious and community leaders can help foster a supportive environment.

Moreover, streamlining processes for donor registration and enhancing medical infrastructure for transplants are crucial to bridging the demand-supply gap and saving more lives. This article discusses the legislation, loopholes therein and suggestions for battling low supply in India.

The Relevant Laws

The law on organ donation in India is primarily governed by the Transplantation of Human Organs and Tissues Act, 1994, as amended in 2014 (THOA), read with the Transplantation of Human Organs and Tissues Rules, 2014 (Rules).

THOA came into force in 1995, after a major racket in illegal kidney trade was uncovered in Bangalore. The law was intended “to provide for the regulation of removal, storage and

Since BSD is only recognized for organ donations, doctors cannot legally remove life support of a BSD patient unless the patient’s organs can be removed for transplantation under the Act

transplantation of human organs for therapeutic purposes and for the prevention of commercial dealings in human organs.” It legally recognised the concept of brain-stem death (BSD), thus opening the way for a program of organ transplants from cadavers. It explicitly illegalised commerce in human organs, thus making kidney-for-cash transactions a criminal offence.

Under THOA, the source of the organ may be:

  • Near relative donor (mother, father, son, daughter, brother, sister, spouse);
  • A donor who can donate out of affection and attachment or for any other special reason and that too with the approval of the authorisation committee.
  • Deceased donor, especially after BSD—for example, a victim of road traffic accident- -where the brain stem is dead and person cannot breathe on his own but can be maintained through ventilator, oxygen, fluids, etc. to keep the heart and other organs working and functional.
  • Other type of deceased donor could be a one after cardiac death.

Despite a facilitatory law, organ donation from deceased persons continues to be very poor. In India there is a need to promote deceased organ donation as donation from living persons alone cannot take care of the organ requirement of the country.

Recognition of BSD as death is recognised as a legal in India only under THOA.If implemented properly, it has the potential to revolutionise the concept of organ donation as after BSD almost 37 different organs and tissues can be donated, including vital organs such as kidneys, heart, liver and lungs.

The BSD Conundrum

While THOA recognises BSD as actual death for the purpose of organ donation, legislations like the Registration of Births and Deaths Act, 1969 (RBD Act) and Indian Penal Code, 1860 (IPC)/ Bhartiya Nyay Samhita (BNS) do not recognise BSD. The RBD Act defines ‘death’ as “permanent disappearance of all evidence of life”, while the IPC/BNS defines it as “death of a human being, unless the contrary appears from the context”. Both being negative definitions, exclude BSD, where despite the fact that the patient will never regain consciousness, the body and heart can be artificially oxygenated with a ventilator

This legislative vacuum causes significant problems for doctors. Since BSD is only recognised for organ donations, doctors cannot legally remove life support of a

The current stress on donation after circulatory death to increase the organ pool requires that we define how long doctors should wait before they can safely proceed to organ donation.

BSD patient unless the patient’s organs can be removed for transplantation under the Act. This results in a contentious situation where if a family is informed that the patient is “dead”, but they refuse consent for organ donation and want the body be handed over, their request to remove life support must be refused.

On the one hand, removing life support could result in legal consequences for the doctor (including charges of criminal negligence/ murder) since there is no legal sanction under the RBD Act to withdraw life support for a BSD patient, on the other hand, there is an ethical obligation to contribute scarce medical resources (like ventilators and intensive care unit wards) towards patients who have a chance to recover.

To address this issue, it would help to adopt a uniform definition of ‘death’ across legislations, which includes both the circulatory and neurological criteria. This would involve the inclusion of BSD in the RBD Act, IPC/BNS and other relevant legislations. Uniform legislation on death will require mentioning brain death as a form of death in the Registration of Births and Deaths Act and this will need to be included in the certificate too.

The current stress on donation after circulatory death to increase the organ pool also requires that we in India define how long doctors should wait after asystole has occurred--before they can safely proceed to organ donation. In the UK this ‘no touch time’ is defined as 5 minutes while in some other countries it is 10 and even 20 minutes in the case of Italy. When legislating the definition of death, a consensus is required from medical professionals about the ‘no touch time’ for organ donation and it needs to be included in the law too for safely proceeding to organ donation.

To summarise, while the framework for organ transplantation in India addresses BSD and prohibits the commercialisation of organs, it faces challenges in implementation and public awareness. Strengthening these areas could enhance the effectiveness of the existing legal framework.

Several key factors contribute to the crisis concerning organ donation in India:

Social Stigma: Many potential donors and their families are unaware of organ donation processes, or are deterred by cultural and religious beliefs. Myths and misconceptions further reduce the willingness to donate.

Legislative Framework: While the Transplantation of Human Organs and Tissues Act, 1994 (amended in 2014) and the related rules provide the legal framework, ambiguities and inefficiencies persist. For example:

  • The Act mandates a stringent process for organ donation, especially in cases of brain death, but the lack of clear guidelines for enforcement creates inconsistencies.
  • The definition and certification of brain death remain contentious, and training for medical professionals in this area is limited.

Inefficient Regulation:

Regulatory agencies, both at the national and state levels, face challenges such as:

  • Limited coordination between hospitals and organ retrieval centers.
  • Delays in organ allocation due to bureaucratic procedures.
  • Inadequate monitoring of compliance with the law

Insufficient Infrastructure:

Many regions lack necessary healthcare infrastructure, such as transplant facilities and organ retrieval organisations. This results in organs being wasted due to logistical inefficiencies.

Ethical Concerns: Despite the Act’s provisions to curb organ trafficking, black market activities persist due to weak enforcement mechanisms. This undermines public trust in the system.

Role of Family Consent: Even after an individual registers as an organ donor, family’s refusal at the time of death often overrides this consent, further reducing the number of donations.

Potential Solutions

Addressing these challenges holistically requires concerted efforts from policymakers, healthcare providers and society at large. Some of the measures could be:

Awareness Campaigns: The government and nongovernmental organisations should collaborate to educate the public about the importance of organ donation, debunk myths and promote voluntary registration.

Streamlining Legal Processes: Clarifying legislative ambiguities, ensuring uniform application of the law, and simplifying procedures can encourage more donations.

Strengthening Healthcare: Investing in hospitals, organ banks and retrieval centres, particularly in rural areas, can improve access and reduce wastage.

Training and Capacity Building: Medical professionals should be trained to handle brain death certification, donor management and organ retrieval more effectively.

Digitisation and Transparency: A centralised, digital registry and allocation system can improve coordination and foster trust in the fairness of organ distribution.

Promoting Ethical Practices: Strict enforcement against trafficking and corruption is essential to protect donors and recipients and restore confidence in the system.

Need for Data Privacy

There is a need for a robust law to ensure protection of the data privacy of organ donors and recipients as medical history and records are shared. There is a need for transparency and ethical practices in the handling of personal data related to organ transplants. Deceased donor details, such as name and identifiable information, should not be published in the media1.

Government Initiatives

National network division of National Organ and Tissue Transplant Organisation2 (NOTTO) functions as the apex centre for activities of coordination and networking for procurement and distribution of organs and tissues and registry of organs and tissue donation and transplantation in the country. These activities are undertaken to facilitate organ transplantation in the safest way in the shortest possible time and to collect data and develop and publish a national registry. Similarly, Regional Organ and Tissue Transplant Organisation and State Organ and Tissue Transplant Organisation have been set up to:

  • Lay down policy guidelines and protocols for various functions.
  • Network with similar regional and state level organisations.
  • Compile and publish all registry data from states and regions.
  • Create awareness, promotion of deceased organ donation and transplantation activities.
  • Co-ordinate the process from procurement of organs and tissues to transplantation when organ is allocated outside region.
  • Disseminate information to all concerned organisations, hospitals and individuals.
  • Monitor transplantation activities in the regions and states and maintain a data bank for it.
  • Assist the states in data management, organ transplant surveillance and organ transplant and organ donor registry.
  • Provide consultancy support on the legal and non-legal aspects of donation and transplantation
  • Coordinate and organise trainings for various cadre of workers.

Present Scenario

Although critical care and number of ventilators have improved in our country postcovid, still BSD declaration is low due to lack of sensitisation among the doctors. Telangana, Tamil Nadu, Karnataka, Gujarat and Maharashtra have reported highest number of deceased organ donors.3 Delhi-NCR, Tamil Nadu, Kerala, Maharashtra, and West Bengal are prominent regions with a high number of living donors.

Tamil Nadu offers free transplants for various organs, including heart, lung, liver and kidneys, under the Chief Minister’s Comprehensive Health Insurance Scheme4 . There is a need to study the executive orders passed by these states and the same could be replicated by other states.

Suggestions

Centers of Excellence should be set up by the government to increase the involvement of public hospitals in transplantation as they are the only ray of hope for poor people. Sustained media campaigns should be undertaken to bridge the awareness gap. To increase the organ donation rate, NOTTO should come forward to involve religious gurus and leaders for awareness and sensitisation of general public and to increase the involvement of their communities.

NOTTO, ROTTO and SOTTO’s SWAP donation through information, education and communication activities is bound to reduce the demandsupply gap. One nation-one advisory is a step forward for SWAP transplantation along with state and central registry. User friendly software for digitalised application and document verification (linked with Aadhar) can be helpful in streamlining and fastening the SWAP transplant5 .

Mandatory counselling about all replacement therapies should be given to the patients so that they can take informed decision before registering in the deceased organ donors list. While many of these objectives are in the schemes of the government, timely and effective implementation is the only way forward.

References

  • NOTTO, GoI. (2024, January 19). A Report on National Symposium on Legal and Ethical Aspects of Organ Donation and Transplantation. Retrieved Nov 15, 2024, from www.notto.mohfw.gov.in
  • Update on THOTA. (2020, 07 16). Transplantation of Human Organs and Tissues Act (THOTA). www.dghs.gov.in
  • Ray, K. (2024, Aug 3). Organ transplants: 90% of deceased donors are from five states only. Deccan Herald. Retrieved Oct 12, 2024, from https://bit.ly/4fFAaey
  • Narayan, P. (2024, Sep 23). TN Retrieves 7,200 organs from nearly 2000 donors in 16 years. ToI. Retrieved Oct 25, 2024, from https://bit.ly/3DPKxiv
  • Supra note 1

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