TRANSPLANTATION OF HUMAN ORGANS ACT by gjjur4356

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									 TRANSPLANTATION OF HUMAN
ORGANS (AMENDMENT) BILL 2009


    Parliamentary
  Committee’s Report
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• September, 2004 - Review Committee set
  up to examine provisions of THO Act and
  the Rules.
• Transplantation of Human Organs and
  Tissues (Amendment) Bill, 2008 –
  Drafted by Ministry of Health.

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   THO Act to cover both organs & tissues


• THO Act to be now called „Transplantation
  of Human Organs & Tissues Act.‟


• PC - Specific provisions relating to tissues,
  keeping in view the characteristics of
  tissues as distinct from human organs,
  may be incorporated in the Act.
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   Expansion of the term “Near Relatives”


• „Near Relative‟ - To include grandparents
  and grandchildren, in addition to spouse,
  son, daughter, father, mother, brother or
  sister (Section 2)
• PC - No further expansion is required in
  the definition of “near relative.”

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          Definition of Tissue

• Group of cells except blood performing a
  particular function in the human body.
• Specify types of tissues (like corneas,
  bone, cartilage, tendon, heart valves,
  blood vessels, skin etc.)
• Include in Rules.
• PC: In agreement
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       Definition of Tissue Bank

• Facility that is registered and regulated
  under law to engage in the recovery,
  screening, testing, processing, storage or
  distribution of tissue or cells. It does not
  include blood banks.
• PC : In agreement – Include in Act

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Definition of Transplant Coordinator

• “Transplant coordinator means a person of
  the hospital appointed for coordinating all
  matters     relating  to    removal     or
  transplantation of human organs or tissues
  or both.”



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Definition of Transplant Coordinator

• PC     –    Appointment    of     transplant
  coordinator beneficial for the organ
  donation and transplantation programme.
  Specific rules regarding qualifications of a
  transplant coordinator to be formulated
  under the Act.


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              Required Request

• Mandatory for ICU/ Treating Medical Staff 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.
• Start with required request in case of corneas.



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          Required Request

• PC: Request to be made by Transplant
  Coordinator
• Hospitals with ICU unregistered under
  THO Act– To be registered under Clinical
  Establishments Act first



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     Special Provision for Removal of
                 Corneas
• Currently organs allowed to be removed by an
  RMP only.
  – Hampering eye donation programme.
• Technician possessing such qualifications and
  experience    as    may     be   prescribed,         may
  enucleate an eye.
  – PC: Technicians can remove other tissues also.


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       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.
• PC: In agreement.
To keep a larger pool of such experts.

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               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.
• PC: All cases involving a foreign national as a donor or
  recipient to be routed through the Authorization
  Committee even if the donor and recipient are near
  relatives.
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                       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).
• PC: Protection to be extended to mentally challenged
  people also.

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               Swap Donations

• Two different willing but incompatible „near
  relative‟ donors (vis-à-vis their intended related
  recipient) permitted to donate their organs.
• Authorization committee will evaluate on a case-
  to-case basis.
• PC: Explore viability of expanding two-donor
  recipient pairs.

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       Authorisation Committees
• Hospital/District/State level Authorisation
  Committees
• Central Government to prescribe composition of
  Authorisation Committees to ensure uniformity
• Actual appointments made by respective State
  Governments / Union Territories.
• PC: Give all jurisdictional powers (Powers of
  Civil Courts) to the Authorisation Committee.
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            Advisory Committee

• To assist Appropriate Authority in the discharge
  of its functions.
• PC: Include representatives of reputed NGOs in
  the field of Organ Donation and Human Rights
  Groups. Also        include experts from more
  specialities   (should   not   be   members      of
  transplant team)


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         Appropriate Authority

• PC: A fully empowered Appropriate
  Authority would go a long way in curbing
  commercial dealing in organs and also
  enabling the reach of much-needed
  organs to the rightful recipients.



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National Human Organs and Tissues
   Removal and Storage Network

• PC:
  – The Committee recommends the establishment of a network on
    the lines of “National Register of Clinical Establishments”
    proposed under the Clinical Establishments Act (Registration &
    Regulation) along with a replica of the same at the State level to
    be termed as State Human Organs and Tissues Removal and
    Storage Network. This would facilitate in gathering and
    dissemination of information from the hospital and state level.




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  National Human Organs and Tissues
     Removal and Storage Network

• PC:
  – A thorough study of existing networks in Tamil Nadu,
    Maharashtra and Karnataka to be done. Based on their
    experience, a model framework can be circulated to all the
    states.
  – All information related to the Network should be put on a
    dedicated website of all the State health departments.
  – Priority to be given to critical patients (recipients) in the
    same hospital/district


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  National Organ Retrieval, Banking and
                Network
PC - Establish 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

  The word Transplantation is missing – ? Oversight



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  National Organ Retrieval, Banking and
            Storage Network
• Maintain     waiting   list        of    patients   awaiting
  transplantation.
• Different lists for different organs.
• Facilitate   matching         of        organs   through      a
  computerized database.
• PC: National/State Registry:
   – Maintain list of living donors (to assess outcomes),
     and donors who have pledged their organs.
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        Registration of Hospitals

• Mandatory for Transplant Hospitals (prior to
  Registration) to appoint Transplant Coordinator.
• Donor Transplant Coordinator
• Recipient Transplant Coordinator
PC: In agreement. A transplant coordinator would
  be more of a counselor who is trained in dealing
  with human emotions and sentiments.

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       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.


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      Review of Penal Provisions

• Enhancement of Penalties
• Imprisonment - 5 -10 years
• Fine - Rs. 5 lakh – Rs.20 lakh.


• PC: In agreement.
  – But recommends differential penalty for violation with
    regard to tissue transplants.


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 SUGGESTIONS ON SECTIONS NOT
COVERED IN THE AMENDMENT BILL




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   Amendment in Section 2: Definitions

• Sub-section (k) – Payment
• 16.1.3 - The definition of payment to also exclude:
• Cost of maintenance of brain dead donor.
• Transportation of deceased donors between hospitals
  and for burial/cremation.
• Costs of any recognition/award/benefit given to family of
  deceased donor.



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  Amendment in Section 3: Authority for
      removal of human organs
• Consent for removal from “Person lawfully in possession
  of the dead body”
      • - To work with Ministry for Home Affairs to list priority of relatives
        who can give consent so that there is no ambiguity.
      • - National Registry - list of donors who have pledged their organs
        to be maintained after due verification process.

• Formal permission of near relative not mandatory in
  these cases.




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  Amendment in Section 5: Authority for
   removal of human organ in case of
  unclaimed bodies in hospital or prison
• 16.3.2 – Examine viability of maintaining unclaimed
  deceased donors in well-equipped hospitals for 48 hrs.
• Examine viability of tissue retrieval (presumed) in such
  cases.
• Identity of unclaimed body – Health Dept. to work with
  Home Dept.




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Amendment in Section 6: Organ removal
 in case of post-mortem requirement

• 16.4.2 – Health Dept. to work with Home Dept.
  in making legal provisions so that organ retrieval
  and post-mortem can be done simultaneously.




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    Amendment in Section 10: Regulation of
   Hospitals conducting removal, storage and
       transplantation of human organs


• 16.5.3 – Organ retrieval may be allowed in unregistered hospitals,
  but the retrieving team has to be from a registered hospital.
• Registered hospitals can be made coordinating units for a particular
  area with jurisdiction over small and unregistered hospitals
• Provision to be made in Clinical Establishments Act.
• 16.5.4 – Tissues may be exempted from the above (excluding
  tissues which require specialized procedures of retrieval)




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 Amendment in Section 14: Registration
of Hospitals conducting removal, storage
  and transplantation of human organs

• 16.6.4 – Special status for tissues as they differ
  from    organs     in   removal,    storage       and
  transplantation.
• Tissue banks need to be registered.
• Specify extent of waiver for registration of
  institutions engaged in tissue transplantation.


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                        Miscellaneous

• 17.3 (1) – Mandatory to exercise the option of organ donation in the
  Biometric National ID card.
• Re-visit mandatory 48-hour waiting period in unclaimed bodies.
• Exercise option of organ donation in driving license.
• Exercise option of organ donation while filing annual income tax
  returns/property tax.
• Initiative in CGHS.
• Data collected from above sources to be updated in National
  Registry (donors who have pledged organs).



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                  Miscellaneous

• Trauma centres to be set up for RTA victims. In case of
  brain death, organ retrieval can take place.
• IEC campaign (Information, Education, Communication)
  on organ donation by Health Dept – pamphlets, ads,
  documentaries on TV channels, radio
• Compulsory in curriculum of schools and universities
  (HRD Ministry)




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                   Miscellaneous

• State governments to felicitate families of deceased
  organ donors.
• Free medical facilities to all live unrelated donors.
• Infrastructure for at least one registered hospital (for
  transplants) within 50-75 km radius.
• National Organ Donor Day
• National toll-free helpline.



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