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TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) BILL 2009

TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) BILL 2009. Parliamentary Committee’s Report. 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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TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) BILL 2009

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  1. TRANSPLANTATION OF HUMAN ORGANS (AMENDMENT) BILL 2009 Parliamentary Committee’s Report

  2. 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.

  3. 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.

  4. 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.”

  5. 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

  6. 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

  7. 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.”

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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)

  18. 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.

  19. 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.

  20. 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

  21. 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

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. SUGGESTIONS ON SECTIONS NOT COVERED IN THE AMENDMENT BILL

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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)

  32. 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.

  33. 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).

  34. 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)

  35. 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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