Monday, September 3, 2012

Transplantation of Human Organ Rules, 2012

You might have to prove that the recipient and you have been staying together and sharing the same kitchen for 10 years or more.

You have to also produce "old photographs showing the donor and the recipient together".

Under the new draft of the Transplantation of Human Organ Rules, 2012, prepared by the Union health ministry in consultation with several experts on August 30, an unrelated donor may also be interviewed along with h/his family member "regarding awareness about his or her intention to donate an organ, the authenticity of the link between the donor and the recipient and the reasons for donation".

The draft says any "strong views or disagreement or objection of such kin shall be recorded and taken note of."

The unrelated donor and the recipient might also have to supply income statement for the previous three financial years.

"Any gross disparity between the status of the two must be evaluated in the backdrop of the objective of preventing commercial dealing," the draft exclusively available with TOI said.

It says a donor will have to undergo a psychiatric evaluation to certify that s/he is not mentally challenged.

The director general of health services Dr Jagdish Prasad chaired a meeting with experts on August 30 to finalize the new rules that gives a big push to harvest organs from brain dead patients.

Dr Prasad said, "I am not happy with the recommendation that the recipient and the donor will have to share the same kitchen for 10 years or produce photos showing them together. We will change it. These recommendations will be put up before the public. It will take around two months before it is notified."

He added, "We are trying to make it easier for unrelated donors to donate organs like Singapore has done. However, we will ensure no commercial transactions take place for such organ donations."

Dr Ravindra Nath, chairman of Global hospitals and a liver transplant surgeon, said, "sharing the same kitchen or asking them to produce photographs to establish relationship are likely to be voted out when the draft is vetted by the law ministry. It is not scientific."

The draft defines near relatives as persons related genetically "specifically grandmother, grandfather, mother, father, brother, sister, son, daughter, grandson and granddaughter above the age of 18 years".

The new draft says when the proposed donor or the recipient or both are foreigners, a senior Embassy official of the country of origin or the government of the country concerned (authenticated by the Embassy concerned in India) has to certify the relationship between the donor and the recipient.

"An authorization committee will have to examine the cases of all Indian donors consenting to donate organs to a foreign national (who is a near relative), including a foreign national of Indian origin, with greater caution. Such cases should be considered rarely on case to case basis," the draft says.

It says in cases where the donor is a woman, "greater precautions ought to be taken. Her identity and independent consent should be confirmed by a person other than the recipient. Any document with regard to the proof of residence and particulars of parentage should be relatable to the photo identity of the applicant in order to ensure that the documents pertain to the same person, who is the proposed donor." The draft has also put in place a priority list.

It says potential liver recipients in hospitals are to be listed in two categories — urgent or standard. Those on the urgent list will be patients who have "hepatic artery thrombosis following a liver transplant, primary non function of a graft or fulminant hepatic failure. Patients on the urgent list will supersede the standard list."

Similarly, potential heart recipients in hospitals will also be listed in categories like urgent or standard.

"Urgent patients will be patients with Left Ventricular Assist Device (LVAD), followed by patients with Intra-aortic Balloon Pump (IABP). For kidneys no out of turn allocation would be permitted," the draft says.

Hospitals having ICU facilities will have to maintain a record in the admission form for the person requiring admission by adding the following line "whether the person has pledged anytime to donate any of his organs/tissues/both after his death for therapeutic purpose."

The draft says, "As soon as a patient is declared dead/brain dead, the medical practitioner in consultation with the transplant coordinator shall proceed to ascertain from the near relative that if the deceased person had any time before his/her death authorized removal of his organs or tissue. If such authorization was made then the hospital would request the near relative to provide a certified copy of the document indicating such authorization."

"If no such authorization is available then the registered medical practitioner and the transplant coordinator shall counsel the near relatives for the option to donate the organs of the deceased person. When the near relative or person in lawful possession of the dead/brain dead patient is willing to donate his/her organ to benefit others, the organs will be shared first with a patient who is to be a multi organ recipient," it adds.

India recently legalized swapping of vital organs between willing but incompatible donors. Till recently, transplants could take place only between blood relatives and relatives emotionally close to the patient. Swapping will help patients who have relatives willing to donate but are medically incompatible for the recipient. Under this system, when a donor's organ isn't compatible with h/his own relative but is suitable for another, two families, unknown to each other, can exchange the organs.

The draft recommends a single state-level authorization committee along with additional authorization panels in districts or hospitals. No member from the transplant team of the hospital can be a member of the authorization committee. A hospital based authorization committee will have to be chaired by the senior most official of the hospital. Other members of the committee would include two senior doctors from the same hospital who are not part of the transplant team, two persons of high integrity, social standing, 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 and doctors (of Indian Medical Association) and secretary (health) or a nominee.

The new draft bars drug addicts from becoming donors.

Chennai-based heart transplant surgeon Dr KM Cherian agrees that donors should not have a history of drug abuse. "Using organs from drug addicts may raise risks of infection for recipients and put their lives at risk. Drug addicts, particularly those who use injectables, may be in the early stages of infections like HIV or Hepatitis. These may not even be detected in the blood test, but can infect recipients,"

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