The transplantation of human organs amendment act 2011
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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.

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THE TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) ACT, 2011

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The transplantation of human organs amendment act 2011

THE TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) ACT, 2011

AMENDMENTS


The transplantation of human organs amendment act 2011

  • 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

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

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)


Definitions1

Definitions

Human Organ Retrieval Centre

  • Hospital with adequate ICU facilities, but not registered under the THO Act

  • Hospital registered under the THO Act


Definitions2

Definitions

Tissue

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


Definitions3

Definitions

  • Transplant Coordinator

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


Required request

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

Special Provision for Removal of Corneas

  • Technician possessing such qualifications and experience, as may be prescribed, may enucleate an eye.


Certification of brain death

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

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

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

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

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

Transplant Coordinators

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


Appropriate authority

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

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 authority1

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

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

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 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

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

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 network1

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

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

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 penalties1

Offences & Penalties

  • Live unrelated organ donation – false documents

    • Imprisonment – 5 to 10 years

    • Fine – Rs.20 lakh to Rs.1 crore


Offences penalties2

Offences & Penalties

  • Supplying tissues for payment

    • Imprisonment 1-2 years

    • Fine: Rs. 5-20 lakh


Offences penalties3

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 NGOs

  • Registration of Non-Government Organisations with Appropriate Authority

  • New section 17-D to be introduced.


Power to make rules

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 rules1

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 rules2

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 rules3

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.


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