What is a competent authority?
It means the Head of the institution or hospital carrying out transplantation or committee constituted by the head of the institution or hospital for the purpose.
What is its role?
To give clearance to all near relative based transplants. The competent authority may seek the assistance of the Authorisation Committee in its decision making, if required.
What is authorisation committee?
For giving clearances in case of transplant is between other than near relatives and all cases where the donor or recipient is foreign national (irrespective of them being near relative or otherwise), the approval will be granted by the Authorisation Committee of the hospital or if hospital based Authorisation Committee is not constituted, then by the District or State level Authorisation Committee.
What is the composition of Authorisation Committees?
1. There shall be one State level Authorisation Committee.
2. Additional Authorisation Committees in the districts or Institutions or hospitals may be set up as per norms given which may be revised from time to time by the concerned State Government or Union territory Administration by notification.
3. No member from transplant team of the institution should be a member of the respective Authorisation Committee.
4. Authorisation Committee should be hospital based if the number of transplants is twenty five or more in a year at the respective transplantation centres, and if the number of organ transplants in an institution or hospital are less than twenty-five in a year, then the State or District level Authorisation Committee would grant approval(s).
What constitutes hospital based Authorisation Committee?
The hospital based Authorisation Committee shall, as notified by the State Government in case of State and by the Union territory Administration in case of Union territory, consist of
(a) The Medical Director or Medical Superintendent or Head of the institution or hospital or a senior medical person officiating as Head - Chairperson;
(b) Two senior medical practitioners from the same hospital who are not part of the transplant team – Member;
(c) two persons (preferably one woman) of high integrity, social standing and credibility, who have served in high ranking Government positions, such as in higher judiciary, senior cadre of police service or who have served as a reader or professor in University Grants Commission approved University or are self-employed professionals of repute such as lawyers, chartered accountants, doctors of Indian Medical Association, reputed non-Government organisation or renowned social worker - Member;
(d) Secretary (Health) or nominee and Director Health Services or nominee from State Government or Union territory Administration - Member.
What constitutes State or District Level Authorisation Committees?
The State or District Level Authorisation Committee shall, as notified by the State Government in case of State and by the Union territory Administration in case of Union territory, consist of,—
(a) A Medical Practitioner officiating as Chief Medical Officer or any other equivalent post in the main or major Government hospital of the District – Chairperson;
(b) Two senior registered medical practitioners to be chosen from the pool of such medical practitioners who are residing in the concerned District and who are not part of any transplant team– Member;
(c) Two persons (preferably one woman) of high integrity, social standing and credibility, who have served in high ranking Government positions, such as in higher judiciary, senior cadre of police service or who have served as a reader or professor in University Grants Commission approved University or are self-employed professionals of repute such as lawyers, chartered accountants, doctors of Indian Medical Association, reputed non-Government organisation or renowned social worker - Member;
(d) Secretary (Health) or nominee and Director Health Services or nominee from State Government or Union territory Administration–Member: Provided that effort shall be made by the State Government concerned to have most of the members’ ex-officio so that the need to change the composition of Committee is less frequent.
What is the Quorum of Authorisation Committee?
The quorum of the Authorisation Committee should be minimum four and the quorum shall not be complete without the participation of the Chairman, the presence of Secretary (Health) or nominee and Director of Health Services or nominee.
Can the committee be manipulated?
It’s unlikely. The quorum makes its mandatory to have minimum two government representatives.
Can the medical officer of case incharge be a member of any committee?
The medical practitioner who will be part of the organ transplantation team for carrying out transplantation operation shall not be a member of the Authorisation Committee constituted under the provisions of clauses (a) and (b) of sub-section(4) of section 9 of the Act or of the competent authority.
What about if the donor and recipients are both foreign nationals?
When the proposed donor or recipient or both are not Indian nationals or citizens whether near relatives or otherwise, the Authorisation Committee shall consider all such requests and the transplantation shall not be permitted if the recipient is a foreign national and donor is an Indian national unless they are near relatives.
What is to be seen by the authorisation committee if the donors and recipients are not related?
The Authorisation Committee shall evaluate nine points-
· Evaluate that there is no commercial transaction between the recipient and the donor and that no payment has been made to the donor or promised to be made to the donor or any other person
· Prepare an explanation of the link between them and the circumstances which led to the offer being made
· Examine the reasons why the donor wishes to donate
· Examine the documentary evidence of the link, e.g. proof that they have lived together, etc.
· Examine old photographs showing the donor and the recipient together
· Evaluate that there is no middleman or tout involved
· Evaluate that financial status of the donor and the recipient by asking them to give appropriate evidence of their vocation and income for the previous three financial years and any gross disparity between the status of the two must be evaluated in the backdrop of the objective of preventing commercial dealing
· Ensure that the donor is not a drug addict
· Ensure that the near relative or if near relative is not available, any adult person related to donor by blood or marriage of the proposed unrelated donor is interviewed regarding awareness about his or her intention to donate an organ or tissue, the authenticity of the link between the donor and the recipient, and the reasons for donation, and any strong views or disagreement or objection of such kin shall also be recorded and taken note of.
Who will approve the SWAP cases?
Cases of swap donation shall be approved by Authorisation Committee of hospital or district or State in which transplantation is proposed to be done and the donation of organs shall be permissible only from near relatives of the swap recipients.
Can the process be expedited?
When the recipient is in a critical condition in need of life saving organ transplantation within a week, the donor or recipient may approach hospital in-charge to expedite evaluation by the Authorisation Committee.
Who is a near relative?
A: Grandmother, grandfather, mother, father, brother, sister, son, daughter, grandson and granddaughter, above the age of eighteen years. They have to be related genetically.
Who gives clearance in cases of near relatives?
Where the proposed transplant of organs is between near relatives related genetically the competent authority or the Authorisation Committee (in case donor or recipient is a foreigner)
What is their role?
The committee shall evaluate;
(i) Documentary evidence of relationship
Relevant birth certificates
Other relationship certificate from Tehsildar or Sub-divisional magistrate or Metropolitan Magistrate or Sarpanch of the Panchayat
Similar other identity certificates like Electors Photo Identity Card or AADHAAR card
(ii) Documentary evidence of identity and residence of the proposed donor
Voter identity card
Family photograph depicting the proposed donor and the proposed recipient along with another near relative
Similar other identity certificates like AADHAAR Card (issued by Unique Identification Authority of India).
If in the opinion of the competent authority, the relationship is not conclusively established after evaluating the above evidence, it may in its discretion direct DNA Profiling from NABL certified lab.
Can the competent authority be misled?
Only if the above documents are forged. It may be difficult for the competent authority to scrutinise forged documents.
What is the procedure when the donor is a spouse?
Where the proposed transplant is between a married couple the competent authority or Authorisation Committee (in case donor or recipient is a foreigner) must evaluate the factum and duration of marriage and ensure that documents such as marriage certificate, marriage photograph etc. are kept for records along with the information on the number and age of children and a family photograph depicting the entire family, birth certificate of children containing the particulars of parents.
Dr K K Aggarwal