To Standing Committee of Rajya Sabha

The Govt. of India has asked for suggestions for amendment of Transplantation of Human Organs (THO) Act. The altered bill is waiting to be cleared by the Rajya Sabha and it is hoped that the new bill should be applicable in the next 6 months. The current altered THO act plugs many gaps in the living donation programme but does little for the deceased donation and transplantation programme. There are only three recommendations that have been included to promote the programme-

1. Compulsory appointment of Transplant coordinators to get hospital registration

2. In event of brain death in a hospital – it is mandatory to ask for organs

3. Enlarging the pool of doctors to certify brain death

Please refer to link for the amended THO document –

http//164.100.47.5/newcommittee/ press_release/bill/Committee%20on %20Health%20and%20Family%20W elfare/Transplantation_of_Human_Or gans.pdf

The current cadaver organ donation rate in India is 0.14 per million population ( i.e 140 cadaver donation a year – due to high donation rate from Tamil Nadu, Andhra Pradesh and Gujarat ).

Countries such as Spain have a donation rate of 34 per million population. We in India may not reach this figure but have the potential to touch a donation rate of 2 to 3 per million population (2000 to 3000 donation per year) with just a little effort and not too great an expenditure to the exchequer. Even relatively conservative countries with similar GDP as ours (e.g. Turkey and Greece) have been able to achieve a donation rate of 4 to 10 per million population. A donation rate of 2 to 3 per million can take care of the current need for organs in India and would go a long way in overcoming the organ shortage and commerce in organs. The country currently has fatal road traffic accidents of 1,40,000 of whom 70% die due to head injury and most of them succumb to brain death. The pool of potential organ donors in our country exceeds 100,000. A simple 2 to 3% conversion is all that is required to help this programme take off. Following are the suggestions that we have sent to the standing committee, if you wish you could also write to them at the following address –

Ms. Aparna Mendiratta,Jt.Director,

Room No.222, Rajya Sabha

Secretariat,Parliament House Annexe,

New Delhi 110011

Or

Shri Amar Singh

(SP)Chairman- Standing Committee

for Health & Family Welfare

27, Lodhi Estate,

New Delhi.

Email: [email protected]

1. De-linking authorized Transplant Hospitals and Organ Retrieving Hospitals for organ retrieval Reason for recommendation – Brain death can happen in any hospital in the country authorized by Appropriate authority or non-authorized hospital. Restricting organ donation to only registered hospitals restricts the scope of the donation process. This delinking of hospitals would help with the following –

a). Stop moving bodies from unregistered hospitals to registered hospitals – this is very traumatic to relatives and they often withdraw consent when they are told of this requirement.

b). Moving body from smaller towns to a bigger town with authorized centres This has often happened in Tamil Nadu and Gujarat where bodies have been moved from Surat to Ahemdabad and from Salem and Erode to Chennai – almost a distance of 300 kms. After donation the body is again taken back for cremation to the home town. At present, the Tamil Nadu government has made such a provision vide G.O.(Ms.) No. 289 Dated: 5.9.2008 (Heal th and Fami l y Wel fare Department - Non-Transplant centers - Criteria for non-transplant centers to retrieve organs from brain dead persons).

The current amendments includes a Mandatory clause - where in the event of brain death in the ICU, it is mandatory for doctors to ask for organs – in such an event in a nonlicensed centre when doctors makes such request, it is important that in such a hospital surgery for retrieval of organs should be possible.

1. Defining further the term ‘Lawful possession of Body’- The THO Act recognizes a person in ‘lawful possession of the body’ as the authority to give consent for organ donation of the deceased. The term ‘lawful possession’ is ambiguous as the Act fails to explain the term and also the people who can be considered as the ones who are in lawful possession of the body. Therefore it becomes important to incorporate a list of qualified relatives as mentioned in the transplant act from USA & UK (UAGA and HT Act), regarding the persons who have the authority to give the consent. This list should be in the prioritizing order of family members, where, if the member who is on the top of the list is not present, the decision can be taken by the member next to him in the list. This will save time when dealing with the unstable deceased donor. At the time when consent is requested, it would also give legal authority to a relative who may not be-

1. Father or mother.

2. Spouse or partner, including civilpartner

3. Parent or child

4. Brother or sister

5. Grandparent or grandchild

6. Niece or nephew

7. Step-father or step-mother

Definition of next of kin is also

ambiguous in certain situations and

can be similarly defined.

III. Rules related to Post- mortem and organ donation- require procedural simplification.

Reason for recommendation –

1. Solid organ for transplants cannot be removed in the mortuary, whereas post-mortem should be possible in operation room.

2. A retrieval and post-mortem means cutting the body up twice and stitching it back twice, sometimes in the same hospital premises. This is totally meaningless and causes undue delay in handing back the body to the relatives

3. In road traffic accidents the cause of death is well known from the investigations done, moreover many are explored for brain hemorrhage, hence cause of death is well established, so requirement for further post-mortem questionable.

MOHAN Foundation has experience with over 400 donations over the last 10 years and they have frequently noted that the current provision makes organ retrieval surgery on the discretion of the police officials and forensic doctors. In most situations they do not understand the complexity of the situation and organ preservation. Moreover the major cause of brain death in India is from fatal road traffic accidents.

De-linking Brain death from Organ Donation – At present brain death declaration is being only made for organ donation purposes. In many instances when a request for organ donation is refused, the relatives usually do not want the ventilator to be switched off and wish the continuation of the vegetative state.

Reason for recommendation –This puts strain on ICU resources especially in Govt. Hospitals as other needy patients are refused life-saving treatment. The doctors also are on the defensive once they ask for organ donation, as the relatives feel that it is because the doctors have a vested interest they have kept the ventilators going but because they have refused the request they want to get rid of the body by switching off the ventilators. It is recommended that brain death and organ donation should be delinked and death should be separately defined in the constitution.

V. Clarification of Clause for unclaimed body reads as follows- Current Status – “CHAPTER II AUTHORITY FOR THE REMOVAL OF HUMAN ORGANS -Authority for removal of human organs in case of unclaimed bodies in hospital or prison

1. In the case of a dead body lying in a hospital or prison and not claimed by any of the near relatives of the deceased person within 48 hours from the time of the death of the concerned person, the authority for the removal of any human organ from the dead body which so remains unclaimed may be given in the prescribed form by the person in charge for the time being, of the management or control of the hospital or prison or by an employee, of such hospital or prison authorized in his behalf by the person in charge of the management or control thereof.

(2) No authority shall be given under sub-section (1) if the person empowered to give such authority has reason to believe that any near relative of the deceased person is likely toclaim the dead body even though such near relative has not come forward toclaim the body of the deceased person within the time specified in subsection( 1)

Reason for recommendation –

1. This whole clause has no meaning for organ donation unless such body that is left unclaimed in a hospital or a body from the prison is on a ventilator. In ordinary circumstances in 48 hrs the body would be decomposed and no organs can be utilized. In such situations presumed consent for eyes, heart valves, bones and cartilage should be passed.

VII. Sharing of organs and costs: Not much is mentioned on this in THO act Reason for recommendation – sharing between public and private hospitals. Most donations take place at present in Private hospitals. Sharing of organs can take place only if hospitals are allowed to share costs of maintaining brain death, costs of Intensive care and cost of operative procedures. This should be clearly spelled out in the procedures without any ambiguity.

VIII. Current Advisory Committee in draf t recommendat ion – not representative of stakeholders in the deceased donation programme- Should be enlarged –

Objectives of Advisory committee- Should be able to assist the Appropriate authority and include –

(i) Establishing formats and procedures for recipient listing, organ allocation and transfer

(ii) Coordination between hospitals where donor / recipient are located

(iii) Proposing policy initiatives from time to time.

(iv) Need for watching the working of the cadaver organ transplantation program, This Advisory committee should be headed by Chairman and meeting should be convened by Convener who should be nominated -

(i) Chief Secretary, Health or nominee - Chairman

( i i ) DGHS or representative

(iii) Transplant team member x 5 - representing each organ with experience in deceased donation programme

(iv) One member from Transplant Coordinators front

(v) One senior police officer of DIG rank from Police welfare dept / Home Ministry

(vi) Member representative from NGO x 2 that has experience and track record in the field

(vii) One transplant team member from four different hospitals in the country that has maximum experience in deceased donation programme or two from deceased and two from living donation programme.

The Advisory committee shall in turn nominate four sub-committees to assist in its functioning for -

(I) Liver & Pancreas

(ii) Heart & Lungs

(iii) Kidneys

(iv) Eyes.

IX) Recommendations to create

vi s ibi l i t y for organ donat ion

programme -

1. Having a clause of organ donation on Indian driving license – need for dialogue with Home Ministry- a chip on the card is proposed and is in pilot study.

2. Including ‘organ donation slogans’ on the back of heavy vehicles that carry socially relevant messages, concerned ministry needs to be provided with such slogans.

3. Similarly ‘organ donation slogans’ can be displayed on Indian Highways.

4. For the last 20 years the focus of Ministry of Health has been towards eye donation and this has helped the programme to a large extent. It is now time to move forward and change this focus towards donation of all organs (which obviously includes eyes too). A simple example was the Ministry of Health’s letterheads carrying slogans related to eye donation at the bottom . This could change to organ donation slogans – e.g. ‘Ang daan mahadaan.’

5. Carrying these simple organ donation messages and slogans on Television Channels similar to other socially relevant slogans

S�tx
�8��ce:none'>(ii) Convenor, Cadaver Organ Transplant Program,Tamil Nadu (i.e Transplant Co-ordinator, Government General Hospital,Chennai.)

(iii) Director of Medical Education or representative

(iv) Director of Medical and Rural Health Services or representative

(v) Transplant team member, Government Stanley Hospital, Chennai

(vi) Transplant team member, Kilpauk Medical College Hospital,Chennai.

(vii) Transplant team member, Government General Hospital. Chennai.

(viii) One senior police officer of DIG rank or above as nominated by the Director General of Police, Chennai.

( i x ) Memb e r f r om MOHAN Foundation, Chennai.

(x) Member from National Network for Organ Sharing, (NNOS)Chennai.

(xi) One transplant team member from three different hospitals that currently have largest cadaver donation experience.

RESPONSIBILITIES OF TRANSPLANT CENTRE HOSPITALS

G.O.No.288 dated 05.09.2008

Transplant surgery records for a minimum period of ten years.

Availability of a counseling department with trained personnel. Assist in preand post-operative counseling.

Designate in-house person as Transplant coordinator. Coordinates matters relating to organ transplant on behalf of the hospital. Media publicity not to be sought earlier than the date of discharge of recipients.

Positive aspects of organ donation may be highlighted to promote the cause of organ donation. Details of the recipient and ethics of the medical profession not to be compromised. Approximate cost of a transplant surgery to be displayed on website of hospital and the website designated for thi s purpose by the Heal the Department.

NON-TRANSPLANT CENTRES - CRITERIA FOR NON-TRANSPLANT CENTRES TO RETRIEVE ORGANS FROM BRAIN DEAD PERSONS

G.O. NO.289 DATED:05.09.2008

(This G.O. is in the process of having further details added to make it more effective)

C O N V E N O R , C A D A V E R TRANSPLANT PROGRAMME, TAMIL NADU

G.O. NO.296 DATED: 16.09.2008

Convenor - Dr.J.Amalorpavanathan,

Reader in Vascular Surgery, Madras Medical College and Vascular Surgeon, Government General Hospital, Chennai

Central responsibility for coordinating all activities relating to cadaver transplant programme in the state

Design and maintain a computerized waitlist of all potential organ recipients f rom par t icipat ing hospi tal s . Responsible for organ allocation as per guidelines

Seek status reports from all the participating hospitals on brain death occurrences and on transplant activities during each month and their outcomes. Send consolidated report to Government. Report violations to Advisory Committee and forward their recommendations to the Government

Convene meeting of the Advisory Committee once in two months or as needed. Coordinate with Advisory Committee on awareness generation, knowledge development and motivation programmes