THE TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) ACT, 2011 AMENDMENTS

September, 2004 - Review Committee set up to examine provisions of THO Act and the Rules. The Transplantation of Human Organs (Amendment) Bill, 2011 – Drafted by Ministry of Health.

THO Act to cover both organs & tissues Regulation of removal, storage and transplantation of human organs and tissues for therapeutic purposes Prevention of commercial dealings of human organs and tissues

Definitions Expansion of the term Near Relative ‘Near Relative’ - To include grandparents and grandchildren, in addition to spouse, son, daughter, father, mother, brother or sister (Section 2)

Definitions Human Organ Retrieval Centre Hospital with adequate ICU facilities, but not registered under the THO Act Hospital registered under the THO Act

Definitions Tissue A group of cells, except blood, performing a particular function in the human body

Definitions Transplant Coordinator A person appointed by a hospital to coordinate all matters relating to removal or transplantation of human organs/tissues

Required Request Mandatory for ICU doctor, in consultation with transplant coordinator to request relatives of brain dead patients for organ donation. Record of all brain dead patients and that of the next of kin who are approached to be kept.

Special Provision for Removal of Corneas Technician possessing such qualifications and experience, as may be prescribed, may enucleate an eye.

Certification of Brain Death Expansion of certifying panel of experts. In addition to neurosurgeon / neurologist, surgeon / physician and an anesthetist/ intensivist nominated from a panel already approved by the Appropriate Authority.

Foreign Nationals Authorisation Committee to prohibit organ transplantation where recipient is a foreign national and donor is an Indian national. Approval of Authorisation Committee required - Donor and / or recipient being near relatives are foreign nationals.

Minors No human organs or tissues to be removed from living minor for transplantation. Exceptions Familial donation of regenerative cells (when a therapeutically comparable adult donor is not available) Kidney transplants between identical twins (Ensure no genetic disorder present. No immunosuppression required for recipient twin).

Mentally challenged No human organ or tissue to be removed from the body of a mentally challenged person before his death for the purpose of transplantation. Mental illness like dementia, schizophrenia Mental retardation

Swap Donations Two different willing but incompatible ‘near relative’ donors (vis-à-vis their intended related recipient) permitted to donate their organs. Authorisation committee will evaluate on a case-to-case basis.

Transplant Coordinators Mandatory for hospitals, prior to registration as a transplant centre, to appoint a Transplant Coordinator.

Appropriate Authority Single member body Central Government for Union Territories - Director General of Health Services, Government of India State Government for States - Secretary (Health) or the Director of Health Services of the State Government concerned.

Powers of the Appropriate Authority To grant registration to a hospital for the removal, storage and transplantation of any human organ. To suspend or cancel such registration. To enforce standards for hospitals engaged in the removal/ storage or transplantation of human organs.

Powers of the Appropriate Authority To investigate any complaint or breach of any provision of the Act or the Rules. To inspect hospitals periodically for examination of the quality of transplantation and follow-up medical care to the recipients as well as donors. Power to summon persons, seek production of documents, issue search warrants.

Advisory Committee To assist Appropriate Authority in the discharge of its functions Constituted for a period of two years Representation from an NGO working in the field of organ or tissue donation

Authorisation Committees Hospital level Authorisation Committees State or District level Authorisation Committees Central Government to prescribe composition of Authorisation Committees to ensure uniformity Actual appointments made by respective State Governments / Union Territories.

Hospital Authorisation Committee Hospital does more than 25 transplants annually Medical director/superintendent Two doctors not part of transplant team Two members from society Director/secretary of health services

National Registry Central Govt. to development and maintain national registry of recipients. Evaluation of scientific and clinical status of organ transplantation.

National Organ Retrieval, Banking and Transplantation Network Organ Retrieval & Banking Organisation (ORBO) set up at AIIMS in New Delhi. Establishment of a nation-wide network, to include: All transplant centres All retrieval organisations All certified HLA testing labs In future – all trauma centres, all dialysis centres, all hospitals with ICUs

National Organ Retrieval, Banking and Transplantation Network Maintain waiting list of patients awaiting transplantation. Different lists for different organs. Facilitate matching of organs through a computerized database.

Review of Penal Provisions Difficulty in proving that payments have been made for procuring organs Whoever prepares or abets in the preparation and or submission or whoever, submits false documents including wrong affidavits to establish that the donor is making the donation of an organ as a near relative or out of love and affection for the recipient would also be punishable as a person who has offered or received payment for the organs.

Offences & Penalties Enhancement of Penalties Removal of human organ without authority Imprisonment - Up to 10 years Fine - Up to Rs.20 lakh Removal of human tissue without authority Imprisonment - Up to 3 years Fine - Up to Rs.5 lakh

Offences & Penalties Live unrelated organ donation – false documents Imprisonment – 5 to 10 years Fine – Rs.20 lakh to Rs.1 crore

Offences & Penalties Supplying tissues for payment Imprisonment 1-2 years Fine: Rs. 5-20 lakh

Offences & Penalties Penalties for doctors First offence – name struck off from State Medical Council for three years Second offence – name struck off permanently

Registration of NGOs Registration of Non-Government Organisations with Appropriate Authority New section 17-D to be introduced.

Power to Make Rules Expand rule-making powers of Central Government to provide for: Qualification and experience to be possessed by a technician to be eligible for enucleating a cornea. Conditions for an anesthetist/ intensivist and surgeon/ physician for being included on the medical board for certification of brain death.

Power to Make Rules Expand rule-making powers of Central Government to provide for: Qualifications and experience required for the position of transplant coordinator. The composition of Authorisation Committees.

Power to Make Rules Expand rule-making powers of Central Government to provide for: Conduct of business by Authorisation Committees. Narrow exceptions in which transplants from a living minor are to be allowed.

Power to Make Rules Expand rule-making powers of Central Government to provide for: Form and manner for maintaining National Registry Functions to be performed by the National Organs Retrieval Banking and Transplantation Network. Registration of NGOs.