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THE TRANSPLANATION OF HUMAN ORGAN ACT,1994

Organ Transplantation is a boon to medical industry as it has helped in saving the lives of those who would have died otherwise.

In a country like India, there is a great need for human organs for transplantation.

Unofficial statistics from

India indicate that there are nearly 300 deaths every day due to failure of organ. That is more than one lac deaths per year.

INTRODUCTION

In fact, the need far exceeds the supply of transplantable organs.

This disparity has led to the formulation of various legislations, attempting to regulate the scare resources (transplantable human organs) and to help establish an equitable system to allocate the organs where they can do the most good.

INTRODUCTION CONT….

Organ transplantation is the moving of an organ from one body to another or from a donor site on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ.

The person who is donating the organ ( i.e. donor) could either be a living or a deceased or a cadaver.

The human organs that can be transplanted are:Heart , Kidney, Eyes, Liver, Lungs,  

Pancreas,  Intestine, Thymus. Tissues include bones, tendons, cornea,

skin, heart valves, and veins.

WHAT IS ORGAN TRANSPLANATION?

“An Act to provide for the regulation of removal, storage and transplantation of

human organs for therapeutic purposes and for the prevention of commercial dealings in

human organs and for matters connected therewith or incidental thereto.”

-CENTRAL ACT NO 42 , 1994

THE TRANSPLANTATION OF HUMAN ORGAN ACT (TH0A) ‘1994

Need for the act

Gross imbalance

between the new patients being added

for transplant and available

donors.

Around 3,000 patients die every year

due to lack of timely organ transplant surgeries.

95% kidney and liver

transplants are from

living donors

95% kidney

and liver transplan

ts are from living

donors

At present ONLY 1% of

all donations are cadaver.

Organ donation

from dead bodies is a

miniscule 0.5 per one lakh

5,500 kidney transplants in

180 centres, 400 livers in 25

centres and 10-15 hearts in very few centres are done annually.

The list of potential

recipients is mounting day by day and year

Need for the Act

A vast impoverished population.

Lack of appropriate

laws regulating

organ donation.

Readily available trained doctors

willing to do the needful

for a consideration.

Good infrastructure

.

Enterprising middlemen who could

arrange for any and everything.

The THOA was Passed by The Houses of Parliament

Rajya Sabha on 5th May, 1993Lok Sabha on 14th June 1994 Amendments made by the Lok

Sabha agreed to by the Rajya Sabha on 15th June 1994

Assented to on 8th July 19941995- Transplantation of

Human Organ Rules2009-Transplantation of

Human Organs (Amendment) Bill

CHRONOLOGICAL EVENTS

Chapter I – PreliminaryChapter II- Authority for Removal of

Human OrganChapter III- Regulation of HospitalsChapter IV- Appropriate AuthorityChapter V- Registration of HospitalsChapter VI- Offences and PenaltiesChapter VII- Miscellaneous

CONTENTS OF THE ACT

To regulate hospitals involved in the transplantation of human organs and to prevent commercialization, two authorities were formed under the Act,

1. Authorization Committee (AC)2. Appropriate Authority (AA)

Salient Features

Approves the transplants between unrelated donors and

recipients

Establishes that the unrelated donors are not under any

coercion or unduly influenced by monetary considerations to

donate theirorgans.

Seeks NOC from respective domicile states, if donor,

recipientand place of transplantation are in

differentstates.

In case of a Foreign National, approval from the AC is required

over the NOC from their respective country

Functions of AC

The Central Government shall appoint, by notification, one or more officers as Appropriate Authorities for each of the Union territories for the purposes of this Act.

The State Government shall appoint, by notification, one or more officers as Appropriate Authorities for the purposes of this Act.

APPROPRIATE AUTHORITY

to grant registration or renew registrationto suspend or cancel registration to enforce standards for hospitalsto investigate any complaint of breach to inspect hospitals periodically for

examination of the quality of transplantation and the follow-up medical care to persons

FUNCTIONS OF APRPOPRIATE AUTHORITY

Any donor may, in such manner and subject to such condition as may be prescribed, authorize the removal before his death of any human organ of his body for therapeutic purposes.

AUTHORITY FOR REMOVAL OF HUMAN ORGANS

•If any donor had in writing and in the presence of two or more witnesses unequivocally authorized at any time before his death, the removal of any human organ of his body after his death for therapeutic purposes

- The authority given shall be sufficient warrant for the removal for therapeutic purposes of the human organ but no such removal shall be made by any person other than the registered medical practitioner.

AUTHORITY FOR REMOVAL OF HUMAN ORGANS

- Where any human organ is to be removed from the body of a deceased person, the registered medical practitioner shall satisfy himself before such removal by a personal examination of the body where it appears to be a case of brain-stem death, that such death has been certified .

Where any human organ is to be removed from the body of a person in the event of his brain stem death no such removal shall be undertaken unless such death is certified, in such form and in such manner and on satisfaction of such conditions and requirements as maybe prescribed by a Board of medical experts

Where brainstem death of any person less than eighteen years of age occurs and is certified any of the parents of the deceased person may give authority, in such form and in such manner as may be prescribed, for the removal of any human organ from the body of the deceased person.

CONTD

No authority for the removal of any human organ from the body of a deceased person shall be given by a person to whom such body has been entrusted solely for the purpose of interment, cremation or other disposal

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 forty eight hours from the time of the death of the concerned person  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 authorised in this behalf by the person in charge of the management or control thereof.

CONTD.

No medical practitioner or any other person shall conduct or cause to be conducted or aid in conducting by himself or through any other person, any activity relating to the removal storage or transplantation of any human organ at a place other than a place registered under this Act

REGULATION OF HOSPITALS

• No hospital, unless registered under this act, shall conduct or associate with, or help in the removal, storage or transplantation of any human organ.

No donor and no person empowered to give authority for the removal of any human organs shall authorise the removal of any human organ for any purpose other than therapeutic purposes.

REGULATION OF HOSPITALS

•No registered medical practitioner shall undertake the removal or transplantation of any human organ unless he has explained in such manner as may be prescribed all possible effects, complications and hazards connected with the removal and transplantation to the donor and the recipient respectively.

Every application for registration shall be made to the Appropriate Authority

No hospital shall be registered under this Act unless the Appropriate authority is satisfied that the applicant has complied with all the requirements of this Act

The AA issues a license to a hospital for a period of 5 years at a time and can renew the license after that period. Each organ requires a separate license.

Any hospital aggrieved by an order of the Appropriate Authority rejecting/cancelling/suspending an application for registration may, within thirty days from the date of the receipt of the order, prefer an appeal to Central/State Government.

Registration of hospitals

Punishment for violation

Whosoever Carriesout removal ortransplantationswithout authority ispunishable for upto five years and afine of up to Rs10,000.

Now enhanced to10 years and 5lacs inTransplantation ofHuman Organs Bill2011.

Punishment for violation

Offending registered medical practitioner is liable to beremoved from the state medical council roll for two yearsfor the first offence and permanently for any subsequentoffence.

Punishment for violation

Commercial dealings, likeindulging in monetarytransaction for trading inhuman organs, brokeringhuman organ trade deals, andadvertising to solicit clients,are punishable withimprisonment ranging fromtwo to seven years, and afine of Rs 10,000 to Rs20,000

Enhanced to 5-10years and a finebetween 20 lakhto 1 crore inTransplantation ofHuman Organs Bill2011.

Punishment for violation

Punishment For Contravention Of Other ProvisionFor provisions where no punishment has been prescribedImprisonment of up to 3 yearsFine up to Five Thousand Rupees.

No court has shall take cognizance unless complaint has been made by

a) Appropriate authority or on behalf of central / state government

b) Notice of not less than 60 days to Appropriate authority

Metropolitan Magistrate or a Judicial Magistrate of the first class .

COGNIZANCE OF OFFENCE

FOR RELATED DONARS: The relatives who are allowed to donate

include mother, father, brothers, sisters, son, daughter, grandparents and spouse. These first relatives are required to provide proof of their relationship by genetic testing and/or by legal documents.

In the event of there being no first relatives, the recipient and donor are required to seek special permission from the government appointed authorization committee.

THE PROCEDURE AS PER LAW

File an affidavit in the court of a magistrate stating that the organ is being donated out of affection.

THE PROCEDURE AS PER LAW

FOR UNRELATED DONARS:

Undergo number of tests before the actual transplant takes place.

The Authorization Committee set up for the purpose ensures that all the documents

required under the act have been supplied.

If it is found that the money has been exchanged in the process then both the recipient as well as

the donor are considered as prime offenders under the law.

1. To rename the Act as the “Transplantation of Human Organs and Tissues Act”

2. To expand the definition of the term ‘near relatives’ to include grandparents and grandchildren

3. To provide for the enucleation of corneas by a trained technician

4. To enable a surgeon/physician and an anaesthetist/ intensivist to be included in the medical board in the event of non availability of a neurosurgeon/neurologist for certification of brain death

5. To make it mandatory for the ICU/Treating Medical Staff to request relatives of brain dead patients for organ donation 

AMENDMENTS

6. To provide for Swap Donations of organs

7. To empower the Central Government to prescribe the composition of Authorisation Committees and to empower Union Territories to set up their own authorization committees

8. To regulate the transplantation of organs for foreign nationals

9. To prevent the exploitation of minors

 10. To provide for the establishment of Advisory Committees for Appropriate Authorities

11. To vest in Appropriate Authorities, the power to summon persons, seek production of documents, issue search warrants etc

12. To establish a National Organ Retrieval, Banking & Transplantation Network

13. To provide for the development and maintenance of a national registry of the recipients of organ transplants

14. To create the position of a ‘Transplant Coordinator’ in all hospitals registered for organ retrieval and or transplantation

15. To provide for the registration of Non Government Organizations working in the field of organ retrieval and or transplantation in any manner whatsoever

16. To enhance the penalties under the act

17. To expand the rule making powers of the Central Government. 

18. The current age limit of 60-years should be removed for cadaver donors. Improved health and longer life expectancy means some older people could be suitable donors, upping the organ donor count to an extra 10 or 12 a year.

19. It has also been proposed that paired matching should be permitted i. e. if patient A's donor does not match A and likewise for patient B, then donor switch should be allowed, if it results in a match. Swaps or exchanges between families unable to fulfil the need of their family member in need of a transplant due to incompatibility, are known to take place. However, this is not legal and is mostly done under cover. The proposed amendment seeks to convert the de facto into de jure, encouraging more families to swap organs amongst themselves, to be vetted by an authorisation committee.

CONTD…..

20. The law will also make it easier for a spouse to donate an organ. Although the 1994 Act included spouse in the definition of ‘near relative’, a spousal donation was next to impossible because of strictures. But the fact and duration of marriage will still be needed to be established in the new law to protect women from being exploited.

CONTD

No suit, prosecution or other legal proceeding shall lie against any person for anything which is in good faith done or intended to be done in pursuance of the provisions of this Act.

No suit or other legal proceeding shall lie against the Central Government or the State Government for any damage caused or likely to be caused for anything which is in good faith done or intended to be done in pursuance of the provisions of this Act.

MISCELLANEOUS

Case: Unrelated donor..Vs Authorization Committee

IssueAC had rejected the application for organdonation by the sister-in-law. petitionThe prospective recipient filed a writbefore the High Court of Karnataka against theorder of the AC.Petitioners seek direction to the respondents(AC) "to give clearance for the transplantoperation .“

Case study

Reasons Recorded by AC for refusal Donor being sister-in-law was not genetically

related to the recipient.Other near relatives were not being considered as

donors by the family

Final Court Direction Direction was issued to the first respondent to

consider the applications of the petitioners afresh.The Committee had to ascertain from the 2nd

petitioner whether she would be donating the kidney out of "affection and attachment

Continued

Outcome When presented with the provisions of the law,the

AC concludes that if the recipient and donorpledge affection in front of them, they should not object unless there is a complaint or some gross oversight.Finally permission was granted by the AC for the

transplant.

Continued

Control illegal organ transplant & trafficking

To stop commercial dealing in organs especially kidneys.

Accept Brain death as a definition of death.

Define donor eligibility.Prevent manipulation of lower

socio-economic class.Regulate and respect self willing

donors wishes.

IMPORTANCE OF THE ACT

LIVE LIFE THEN

GIVE LIFE……..

DONATE ORGAN

THE LEGAL WAY

Thank

You