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

AMENDMENTSAMENDMENTS

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• September, 2004 - Review Committee set

up to examine provisions of THO Act and

the Rules.

• The Transplantation of Human Organs The Transplantation of Human Organs

(Amendment) Bill, 2011(Amendment) Bill, 2011 – – Drafted by

Ministry of Health.

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THO Act to cover both organs THO Act to cover both organs & tissues& tissues

• Regulation of removal, storage and

transplantation of human organs and

tissues for therapeutic purposes

• Prevention of commercial dealings of

human organs and tissues

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DefinitionsDefinitions

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)

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DefinitionsDefinitions

Human Organ Retrieval Centre

- Hospital with adequate ICU facilities, but

not registered under the THO Act

- Hospital registered under the THO Act

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DefinitionsDefinitions

Tissue

A group of cells, except blood, performing

a particular function in the human body

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DefinitionsDefinitions

• Transplant Coordinator

A person appointed by a hospital to

coordinate all matters relating to removal

or transplantation of human organs/tissues

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Required RequestRequired 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.

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Special Provision for Removal of Special Provision for Removal of CorneasCorneas

• Technician possessing such qualifications and

experience, as may be prescribed, may

enucleate an eye.

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Certification of Brain DeathCertification 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.

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Foreign NationalsForeign 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.

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MinorsMinors

• 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).

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Mentally challengedMentally 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

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Swap DonationsSwap 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.

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Transplant CoordinatorsTransplant Coordinators

• Mandatory for hospitals, prior to registration as a

transplant centre, to appoint a Transplant

Coordinator.

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Appropriate AuthorityAppropriate 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.

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Powers of the Appropriate AuthorityPowers 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.

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Powers of the Appropriate AuthorityPowers 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.

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Advisory CommitteeAdvisory 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

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Authorisation CommitteesAuthorisation 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.

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Hospital Authorisation CommitteeHospital 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

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National RegistryNational Registry

• Central Govt. to development and maintain

national registry of recipients.

• Evaluation of scientific and clinical status of

organ transplantation.

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National Organ Retrieval, Banking and National Organ Retrieval, Banking and Transplantation NetworkTransplantation 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

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National Organ Retrieval, Banking and National Organ Retrieval, Banking and Transplantation NetworkTransplantation Network

• Maintain waiting list of patients awaiting

transplantation.

• Different lists for different organs.

• Facilitate matching of organs through a

computerized database.

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Review of Penal ProvisionsReview 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.

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Offences & PenaltiesOffences & 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

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Offences & PenaltiesOffences & Penalties

• Live unrelated organ donation – false

documents

– Imprisonment – 5 to 10 years

– Fine – Rs.20 lakh to Rs.1 crore

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Offences & PenaltiesOffences & Penalties

• Supplying tissues for payment

– Imprisonment 1-2 years

– Fine: Rs. 5-20 lakh

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Offences & PenaltiesOffences & Penalties

• Penalties for doctors

– First offence – name struck off from State

Medical Council for three years

– Second offence – name struck off

permanently

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Registration of NGOsRegistration of NGOs

• Registration of Non-Government Organisations

with Appropriate Authority

• New section 17-D to be introduced.

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Power to Make RulesPower 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.

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Power to Make RulesPower 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.

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Power to Make RulesPower 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.

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Power to Make RulesPower 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.