Human Organ Transplantation: Legal and Ethical Aspects Chapter Notes | Forensic Medicine and Toxicology (FMT) - NEET PG PDF Download

Introduction

The Transplantation of Human Organs Bill, 1994, governs the removal, storage, and transplantation of human organs for therapeutic purposes while aiming to prevent commercial dealings in human organs and related issues. This legislation, known as the Transplantation of Human Organs Act, 1994, came into effect on February 4, 1995, following a notification in the Government of India Gazette. With the enforcement of this Act, brain death received legal recognition in India. Additionally, the Act led to the repeal of the Eardrums and Ear Bones Act, 1982, and the Eyes Act, 1982.

• Human tissues and organs can be categorized in various ways, but legally, they are classified into two categories:
  • Regenerative. These are tissues or organs that have the ability to regenerate or reproduce themselves.
  • Non-generative. These are tissues or organs that do not have the capacity to regenerate or reproduce themselves.

Regenerative Tissues or Organs

Regenerative tissues or organs refer to parts of the human body that have the ability to grow back, even when they are removed from their usual location within the body.

Examples of Regenerative Tissues

• Blood: Blood is a vital fluid in the body that can be donated, and the body has the capacity to regenerate the donated blood over time.
• Semen: Similar to blood, semen can be donated, and the body can produce more semen after donation.
• Bone Marrow: Bone marrow is a crucial part of the body that can be donated, and the body can replenish its bone marrow after donation.
• Skin: Skin is an organ that can regenerate itself, and when a portion of skin is donated, the body can grow back the lost skin over time.

For example, when a person donates blood or semen, these types of tissues can often grow back. However, some donations of organs may lead to a permanent loss.

Nongenerative Tissues or Organs

• Nongenerative tissues or organs such as the kidney, heart, lung, and liver do not have the ability to regenerate if they are removed from the body.
• Donating these organs means that the donor is losing a vital part of their own body.
• While there are risks involved in such donations, thorough evaluations are conducted to ensure the safety of living donors.
• In some cases, this could result in permanent partial disablement for the donor or even lead to the donor's death.

Concept of Living and Cadaver Donors

• Cadaver donations are becoming increasingly common as medical professionals now focus on donors who are brain dead.
• Advances in medicine allow patients to be placed on an artificial respiratory system or ventilator, which keeps the heart and lungs functioning even when the brain is irreversibly damaged.
• These types of donors are known as “beating heart donors” because their organs can be harvested while they are maintained on a ventilator.

The Transplantation of Human Organs Act, 1994

The increase in the trade of human organs for transplantation during the 1970s and 1980s prompted the World Health Organization (WHO) to establish guiding principles for organ transplantation. It was determined that organs and tissues could be harvested from both deceased and living individuals for transplantation purposes only under specific guiding principles:

Removal of Organs from Deceased Persons

• Organs may be retrieved from deceased individuals for transplantation if:
  • Legal consent is obtained, and
  • There is no evidence indicating that the deceased had objected to such action without formal consent during their lifetime.
• Doctors responsible for confirming the death of a potential donor must not be involved in the organ removal or subsequent transplantation processes, nor should they be involved in the care of potential recipients of those organs.

Donation from Living Donors

• Ideally, organs should be sourced from deceased individuals. However, adult living individuals can donate organs, preferably if they are genetically related to the recipient, with exceptions for regenerative tissues.
• An organ may be harvested from an adult living donor if:
  • The donor provides free consent,
  • The donor is not under any undue influence or pressure, and
  • The donor is fully informed about the risks, benefits, and consequences of their consent.
• Organs should not be harvested from living minors for transplantation, although exceptions may exist under national law for regenerative tissues.

Commercial Transactions and Ethical Practices

• The human body and its parts cannot be bought or sold, making any payment or compensation for organs illegal.
• Advertising the need for or availability of organs for payment should be prohibited.
• Healthcare professionals must refrain from participating in organ transplantation if they suspect the organs were involved in commercial transactions.
• No individual or facility involved in organ transplantation may receive payment exceeding a reasonable fee for the services rendered.
• In accordance with principles of fairness and justice, donated organs should be allocated based on medical need rather than financial capability.

To align with international standards, the Indian Parliament enacted The Transplantation of Human Organs Act, 1994, to govern the removal, storage, and transplantation of human organs for therapeutic purposes, ensuring ethical practices in organ donation and transplantation.

Restrictions on the Removal and Transplantation of Human Organs

Transplantation involves transferring a human organ from either a living or deceased individual to another living person for medical purposes. A human organ is any body part composed of tissues that the body cannot replace if it is entirely removed.

The primary goal of this Act is to regulate and prevent the transplantation of human organs unless it adheres to the specified procedures outlined within the Act. According to Section 9(1), organs taken from a donor before their death can only be transplanted into another person if the donor is a near relative.

• A near relative is defined as a spouse, son, daughter, father, mother, brother, or sister.
• If a donor consents to the removal of their organs after death, those organs can be transplanted to any recipient in need.

In cases where a donor wishes to remove their organs before death and transplant them to a recipient who is not a near relative, based on personal affection or other special reasons, prior approval from the authorisation committee is necessary.

The Act mandates the establishment of one or more authorisation committees by the State Government to oversee this process. Upon receiving a joint application from the donor and recipient, the committee will conduct a thorough investigation to ensure compliance with legal and ethical standards. If satisfied, the committee may approve the removal and transplantation, providing valid justifications for their decision.

Authority for the Removal of Human Organs

Before Death:

• A donor can give permission to remove any human organ from their body for medical reasons before their death.
• If a donor has clearly stated, in writing and in front of at least two witnesses (one being a close relative), that they allow their organs to be removed for therapeutic purposes, the person who has the legal right to the deceased's body can authorise the removal unless they believe the donor changed their mind.

After Death:

• If there is no such permission, the person with legal possession of the body may authorise the removal, as long as it does not conflict with the wishes of the deceased's relatives.

Conditions for Removal
Brainstem Death Confirmation:

• Removal of human organs from individuals diagnosed with brainstem death can only occur after verification by a panel of medical experts, including:
• The registered medical practitioner overseeing the hospital where brainstem death was diagnosed.
• An independent specialist medical practitioner chosen by the first doctor from an approved panel.
• A neurologist or neurosurgeon selected by the first doctor from an approved panel.
• The treating registered medical practitioner of the individual diagnosed with brainstem death.

Minors:

• For individuals under 18 years old who experience brainstem death, parents have the authority to permit organ removal.
• However, if an inquest is planned, such authorization is not permissible.

Unclaimed Bodies:

• In cases of unclaimed bodies (those not claimed by relatives within 58 hours of death), the authority to remove organs is granted to a designated person in the relevant hospital or prison, as authorized by management.

Postmortem Examinations:

• When a body is sent for a postmortem examination, a competent individual designated by the State Government may authorize organ removal for therapeutic purposes, following necessary formalities.

Preservation of Removed Organs:

• According to Section 7, after the removal of any human organ, the registered medical practitioner is responsible for taking appropriate measures to preserve the organ.

Regulation of Hospitals

From the date of the commencement of the Act:

• No hospital, unless registered under this Act, shall conduct, or assist in, the removal, storage, or transplantation of any human organ .
• No medical practitioner or any other individual shall conduct, or cause to be conducted, or assist in conducting activities related to the removal, storage, or transplantation of any human organ at a place that is not registered under this Act.
• No place, including a registered hospital, shall be used by anyone for the removal, storage, or transplantation of any human organ, except for therapeutic purposes .

Offences and Penalties

Section 18: Punishments for Unauthorized Activities:

• Imprisonment: Up to five years
• Fine: Up to ten thousand rupees

Actions Leading to Reporting by State Medical Council:

• First Offence: Name removal from register for two years
• Subsequent Offences: Permanent removal from register

Section 19: Prohibited Actions and Penalties:

• Making or receiving payments for human organs
• Searching for organ sellers
• Offering organs for sale
• Negotiating payment arrangements for organ supply
• Managing deceased bodies for organ supply
• Publishing related advertisements

Penalties for Section 19 Violations:

• Imprisonment: Minimum of two years, up to seven years
• Fine: Ranging from ten thousand to twenty thousand rupees

Special Considerations:

• Judges may impose less than two years of imprisonment for special reasons

Court Action Requirements:

• Complaint by appropriate authority or authorised officer
• Notice to authority at least 60 days in advance

Legislative Measures:

• Thorough against exploitative trade
• Uncertainty about distribution based on medical necessity
• Expectation for all states to pass regulations
• Government to issue relevant rules as per Transplantation of Human Organs Act, 1994