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TRANSPLANTATION OF HUMAN TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) BILL 2009ORGANS (AMENDMENT) BILL 2009

Parliamentary Parliamentary

Committee’s ReportCommittee’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 Transplantation of Human Organs and

Tissues (Amendment) Bill, 2008Tissues (Amendment) Bill, 2008 – –

Drafted by Ministry of Health.

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THO Act to cover both organs & tissuesTHO 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”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 TissueDefinition 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 BankDefinition 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 CoordinatorDefinition 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 CoordinatorDefinition 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 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 RequestRequired 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 Special Provision for Removal of CorneasCorneas

• 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 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.

• PC: In agreement.

To keep a larger pool of such experts.

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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.

• 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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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).

• PC: Protection to be extended to mentally challenged people also.

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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.

• Authorization committee will evaluate on a case-

to-case basis.

• PC: Explore viability of expanding two-donor

recipient pairs.

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Authorisation CommitteesAuthorisation 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 CommitteeAdvisory 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 AuthorityAppropriate 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 National Human Organs and Tissues Removal and Storage NetworkRemoval 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 National Human Organs and Tissues Removal and Storage NetworkRemoval 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 National Organ Retrieval, Banking and NetworkNetwork

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 National Organ Retrieval, Banking and Storage NetworkStorage 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 HospitalsRegistration 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 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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Review of Penal ProvisionsReview 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 SUGGESTIONS ON SECTIONS NOT COVERED IN THE AMENDMENT BILLCOVERED IN THE AMENDMENT BILL

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Amendment in Section 2: Definitions 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 Amendment in Section 3: Authority for removal of human organsremoval 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 Amendment in Section 5: Authority for removal of human organ in case of removal of human organ in case of

unclaimed bodies in hospital or prisonunclaimed 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 Amendment in Section 6: Organ removal in case of post-mortem requirementin 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 Amendment in Section 10: Regulation of Hospitals conducting removal, storage and Hospitals conducting removal, storage and

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

and transplantation of human organsand 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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MiscellaneousMiscellaneous

• 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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MiscellaneousMiscellaneous

• 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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MiscellaneousMiscellaneous

• 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.