Transplantation of Human Organs and Tissue Act, 2010

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THE TRANSPLANTATION OF HUMAN ORGANS AND TISSUES  
ACT, 2010 
 
 
 
  
 
CONTENTS 
 
1. Short title, extent and commencement. 
 
2. Definitions. 
 
3. Donation of organ or tissue by a living person. 
 
4. Donation of human organs or tissues after death. 
 
5. Evaluation Committee. 
 
6. Transplantation to be carried out by the team of transplant surgeons and physicians, 
etc. 
 
7. Effects etc., to the donor and the recipient. 
 
8. Monitoring Authority. 
 
9. Prohibition of removal or transplantation of human organs for any pur pose other than    
therapeutic purpose. 
 
10. Punishment for removal of human organ without authority. 
 
11. Punishment for commercial dealings in human organ.  
 
12. Punishment for contravention of any other provision of this Act. 
 
13. Offences by companies. 
 
14. Cognizance of offences. 
 
15. Savings. 
 
16. Protection of actions taken in good faith. 
 
17. Power to make rules. 
 
18. Removal of difficulties. 

 
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THE TRANSPLANTATION OF HUMAN ORGANS AND TISSUES ACT, 
2010 
ACT No. VI OF 2010 
[17th March, 2010] 
An Act to provide for removal, storage and transplantation of human organs and tissues for 
therapeutic purposes 
 Whereas it is expedient to provide for the regulation, removal, storage and transplantation of 
human organs and tissues for therapeutic purposes and for m atters connected therewith or ancillary 
thereto; 
 It is hereby enacted as follows:___ 
 1. Short title, extent and commencement. ___ (1) This Act may be called the Transplantation 
of Human Organs and Tissues Act, 2010. 
 (2)  It extends to the whole of Pakistan. 
 (3)  It shall come into force at once. 
 2. Definitions. In this Act, unless there is anything repugnant in the subject or context,— 
 
(a) “brain dead” means irreversible loss of brain and brain stem functions  
  simultaneously; 
 
(b) “death” means an irreversible cessation of the entire function of brainstem; 
 
(c) “donor” means a person who donates any part of his body, organ, tissue  or 
  cell; 
 
(d) “Evaluation Committee” means a committee appointed under section 5; 
 
(e) “human organ” means any part of a human body, organ or tissue; 
 
(f) “Monitoring Authority ” means an authority constituted  under section 8 to 
monitor the process of transplantation of human organs or tissues and matters 
relating thereto; 
 
(g) “payment” means payment in money or money's wo rth but do es not include 
any payment for defraying or reimbursing,___ 
(i) the cost of removing, transporting or preserving the human organ to be 
supplied; or 
(ii) any expenses or loss of earnings incurred by a person so far as 
reasonably and directly attributable to his supplying any organ from his 
body. 
 
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(h) “prescribed” means prescribed by rules made under this Act; 
(i) “recognized institution” means a medical institution or hospital for practice of 
operative surgery in transplantation of human organs or tissues to be 
recognized by the Monitoring Authority; 
 
(j) “recognized transplant surgeon or physician ” means Surgeons or Physicians 
possessing appropriate qualifications, experience, and trained in the relevant 
field, to investigate, examine and carry out transplantation surgery of human 
organs or tissues; and 
 
(k) “transplantation” means the grafting of any human organ or tissue of any 
living or deceased person to some other living person for therapeutic purposes. 
3. Donation of organ or tissue by a living  person.___ (1) Notwithstanding anything 
contained in any other law for the time being in force, a living donor who is not less than eighteen 
years of age, may during his lifetime voluntarily donate any organ or tissue of his body to any other 
living person genetically and legally related, who is a close blood relative and the donation of organ 
or part or tissue by such person for therapeutic purpose shall be regulated in the manner as may be 
prescribed. In the case of regenerative tissue, i.e. stem cells, there is no restriction of age between 
siblings. 
 Explanation. ___For the purpose of this section, the expression “close blood relative ” means 
parent, son, daughter, sister, brother and includes spouse: 
 Provided that transplantation shall be voluntary, ge nuinely motivated and without any duress 
or coercion. 
 (2) In case of non -availability of a donor as explained under sub -section (1), the Evaluation 
Committee may allow donation by a non -close blood relative, after satisfying itself that such 
donation is voluntary. 
 4. Donation of human organs or tissues after death. ___ (1) Any person who is not less than 
eighteen years of age may before his death, in writing duly signed and verified by the respective 
Evaluation Committee, donate any of his organ or tissue for transplantation and for this purpose may 
authorize any medical institution or hospital duly recognized by the Monitoring Authority. The cases 
of unclaimed brain dead hospitalized patients shall be presented to an Evaluation Committee for 
transplantation after an intense search for their relatives within twenty-four hours. 
 
 (2) On the death of a d onor referred to in sub -section (1), any close relative of the deceased 
shall inform the Evaluation Committee about the deceased and cause the removal of the h uman 
organ or tissue in accordance with the authorization. 
 
 (3) A donation under this section may be executed in such form and manner as may be 
prescribed and may be revoked at any time during the lifetime of the donor in the presence of two 
witnesses. 
  
 1[4A Provision for donation of human o rgans or tissues after accidental death—(1) The 
authority issuing a driving licence shall make a provision at the first page of a driving licence in the 
form of an undertaking for obtaining consent of applicant of such driving licence regarding donation 
of human organs or tissues in case of accidental death of the holder of such driving licence. 
 
 1 Ins. by the Transplantation of Human Organs and Tissues (Amendment) Act, 2023 (XXIX of 2023), s.2. 
 
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 (2) Whoever apply for  a driving licence may opt for sig ning the unde rtaking as provided in 
sub-section (1) consenting that his organs or t issues may be transplanted to any person in need of 
such human organs or tissues in case of accidental death of the signatory to b e r emoved by the 
nearest authorized medical institution or hospital duly recognized by the Monitoring Authority.  
 (3) The Monitoring Authority, driving licence issuing authority or such other authorities in 
the field of public health shall publ icize the importance to be a deceased donor f or the welfare of 
humanity from different scientific and religious aspects so that people may contribute through their 
voluntary donations of organs and tissues in case of accidental death.] 
 5. Evaluation Committee. ___ (1) As soon as may be after the commencement of this Act the 
Federal Government may, by notification in the official Gazette, appoint as many Evaluation 
Committees as may be necessary which shall consist of a surgical specialist, a medical specialist, a 
transplant specialist, a nephrologist, and a neurophysician and an intensivist where available and two 
local notables having a good record of social service. The Evaluation Committee shall be established 
for every medical institution and hospital where at least twenty -five transplants are being carried out 
annually. 
 (2) The Evaluation Committee shall___ 
(a) ensure that no organ or tissue is retrieved from non -related living donors 
without the prior approval of the Evaluation Committee; 
(b) determine brain death of a person; 
(c) determine propriety of removal of a human organ from any living person using 
brain death protocol to be formulated; and 
(d) determine fitness or otherwise for transplantation of a human organ into any 
other body. 
 6. Transplantation to be carried out by the team of transplant surgeons and physicians, 
etc. ___ (1) The transplantation of human organ or tissue or removal of any part of human organ for 
the purpose of transplantation shall only be carried out by the recognized professionals who shall,  
before the removal of any human organ from the body of the deceased, ensure that written 
certification has been obtained from the Evaluation Committee that death has occurred. 
 (2) For the purpose of sub -section (1) a person shall be deemed to be medicall y and legally 
dead at the time when in the opinion of the Evaluation Committee, based upon acceptable standard 
of medical practice, there is___ 
 
(a) an absence of natural respiratory and cardiac functions and attempt at 
resuscitation are not successful in restoring those functions; or 
 
(b) an irreversible and p ermanent cessation of all brain stem functions and future 
attempt of resuscitation or continued supportive maintenance would not be 
successful in restoring such natural functions. 
 (3) On the commencement of this Act the Federal Government shall on the recommendation 
of the Monitoring Authority, by notification in the official Gazette, publish the list of medical 
institutions and hospitals as recognized medical institutions and hospitals for practice of  operative 
 
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surgery in transplantation of human organs and tissues. The Federal Government may revise the list 
from time to time. 
 (4) No hospital or medical institution shall carry out transplantation of human organs and 
tissues unless it is recognized as provided in sub-section (3). 
 7. Effects etc., to the donor and the recipient.  ___ (1) No transplantation of a human organ 
and tissue from a donor other than defined in sub -section (1) of section 3 shall be carried out without 
prior permission of the appro priate Evaluation Committee and only at such medical institutions and 
hospitals which have been notified under sub -section (3) of section (6) , provided that such donation 
by Pakistani citizens shall not be permissible to citizens of other countries.  
 (2) No human organ or tissue shall be removed from the body of a living person except for 
the purposes of section 3 and no transplantation team of a recognized medical institution or hospital 
shall undertake the removal or transplantation of any human organ or  tissue from a living donor 
unless they have explained the effects, complications and hazards connected with the removal of 
organ or tissue for transplantation to the donor and its outcome in the recipient respectively in such 
manner as may be prescribed. 
8. Monitoring Authority.___ (1) The Federal Government shall, by notification in the official 
Gazette, constitute a Monitoring Authority consisting of the following, namely:___ 
(i) Minister for Health      Chairman 
(ii) Secretary Ministry of Health    Member/ Secretary 
(iii) Surgeon General, Pakistan Army    Member 
(iv) President, Transplantation Society of Pakistan  Member 
(v) Executive Director, Pakistan Medical Research Council Member 
(vi)  President, Ophthalmological Society of Pakistan  Member 
(vii)  President, Pakistan Medical Association of Pakistan  Member 
(viii)  President, Pakistan Society of Gastroenterology  Member 
(ix)  Surgical Transplant Specialist     Member 
(x)  Any other outstanding Medical Specialist whom  Member 
  the Federal Government may nominate     
   
(2) The Authority so constituted shall— 
 
(a) monitor transplantation and enforce prescribed standards for recognized 
medical institutions and hospitals; 
 
(b) investigate and hold inquiry into the allegations of breach of any provision of  
  this Act; 
 
 
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(c) inspect recognized medical institutions and hospitals for examination of 
quality of transplanta tion, follow up medical care of  donor and recipient and 
any other matter ancillary thereto and also periodically inspect institutions 
wishing to be recognized; 
 
(d) cause establishment of a National Registry and national and regional networks 
for evaluating quality  and outcome of transplant centers and cause 
enhancement and promotion of transplantation; and   
 
(e) due to shortage of available hum an organs for transplantation to meet 
lifesaving patient needs; the Monitoring Authority will explore and support the 
international collaboration of xenotransplanation in future, after considering 
all ethical and safety risks and also continue to examine and collect global data 
on the practices, safety, quality, efficacy and epidemiology of stem cell as well 
as non-human organ transplantation. 
 
 (3) The Monitoring Authority shall appoint an Administrator, preferably from the medical 
profession, in consultation with the Federal Government and also appoint such other officers as may 
be required, on terms and conditions, to be determined by it, to carry out the day -to-day business of 
the Authority, for which the Federal Government shall provide a reasonable annual grant. 
 
 (4) The Federal Government in consultation with the Monitoring Authority shall establish a 
fund consisting of grants by the Federal and Provincial Governments and contributions by NGOS, 
philanthropists and other individuals for the transplanta tion or i ndigent patients including post 
transplant care and medicines. 
 
 (5) The pool of voluntary donors and registry of potential recipients shall be established and 
regulated as may be prescribed. 
 
 9. Prohibition of removal or transplantation of human  organs for any purpose other 
than therapeutic purpose.  ___ No donor and no person empowered to give authority for removal of 
any human organ shall authorize the removal of any human organ for any purpose other than the 
therapeutic purposes. 
 
10. Punishment for removal of human organ without authority. ___ (1) Whoever renders 
his services to or at any medical institution or hospital and who for the purposes of transplantation, 
conducts, associates with or helps in any manner, in the removal of any human orga n without 
authority, shall be punished with imprisonment for a term which may extend to ten years and with 
fine which may extend to one million rupees. 
 
 (2) Where any person convicted under sub -section (1) is a registered medical practitioner his 
name sha ll also be reported to the Pakistan Medical and Dental Council for appropriate action 
including removal of his name from the register of the Council for a period of three years for the first 
offence and permanently for subsequent offence. 
 
 11. Punishment for commercial dealings in human organ. ___Whoever—  
 
(a) makes or receives any payment for the supply of, or for an offer to supply, any 
human organ; 
 
 
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(b) seeks to find a person willing to supply for payment of any human organ; 
 
(c) offers to supply any human organ for payment; or 
 
(d) initiates or negotiates any arrangement involving the making of any payment 
for the supply of, or for an offer to supply any human organ,— 
 
(i) takes part in the management or control of a body of persons, whether 
a society, firm, or company, whose activities consist of or include the 
initiation or negotiation of any arrangement referred to in clause (d); or 
 
(ii)  publishes or distributes or causes to be published or d istributed any 
advertisement,— 
 
(a) inviting persons to supply for payment of any human organ; 
 
(b) offering to supply any human organ for payment; or 
 
(c) indicating that the advertiser is willing to initiate or negotiate 
any arrangement referred to in clause (d), 
 
shall be punished with imprisonment for a term  which may extend to ten years and with fine which 
may extend to one million rupees. 
 
12. Punishment for contravention of any other provision of this Act. ___ Whoever 
contravenes any provision of this Act or any rule made, or any condition of the registrati on granted, 
thereunder for which no punishment is separately provided in this Act, shall be punished with 
imprisonment for a term which may extend to three years or with fine which may extend to three 
hundred thousand rupees or with both. 
 
13. Offences by companies.___Where any offence, punishable under this Act has been 
committed by a company, its Chief Executive or Director or any other person who, at the time the 
offence was committed was in charge of, and was responsible to, the company for the conduct of 
business of the company, as well as the c ompany, shall be deemed to be guilty of offence and shall 
be liable to be proceeded against and punished accordingly: 
 
 Provided that a company shall be liable to pay fine only: 
 
Provided further that nothing con tained in this section shall render any such person liable to 
any punishment, if he proves that the offence was committed without his knowledge or that he had 
exercised all due diligence to prevent the commission of such offence. 
 
 Explanation.___For the purposes of this section,___ 
 
(a) “company” means anybody corporate and includes a firm or other association 
of individuals; and 
  
(b) “director”, in relation to a firm, means a partner in the firm. 
 
 
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 14. Cognizance of offences. ___ (1) No Court inferior to that of the Magistrate of First Class 
empowered under section 30 of the Code of Cri minal Procedure, 1898 (Act  V of 1898) shall try an 
offence punishable under this Act. 
 
 (2) No Court shall take cognizance of an offence under this Act except on a complaint  in 
writing made by,___ 
 
(a) the Monitoring Authority or its Secretary; or 
 
(b) an aggrieved person who has given notice of not less than fifteen days, in such 
manner as may be prescribed, to the Monitoring Authority, of the alleged  
offence and of his intention to lodge a complaint. 
  
 (3) Notwithstanding anything in section 32 of the Code of Criminal Procedure, 1898 (Act V 
of 1898) it shall be lawful for a Magistrate referred to in sub -section (1) to pass any sentence 
authorized by this Act even if such sentence exceeds his powers under the said section. 
 
 (4) Notwithstanding anything in the Code of Criminal Procedure, 1898 (Act V of 1898) the 
offences punishable under this Act shall be non-bailable. 
  
15. Savings.___Neither the grant of any facilities of a ny authority for removal of any human 
organ from the body of the donor deceased or alive in accordance with the provisions of this Act nor 
removal of any human organ or tissue from the body of a deceased person with due care in pursuance 
of such authority shall be deemed to be an offence punishable under section 297 of the Pakistan 
Penal Code (Act XLV of 1860). 
 
 16. Protection of actions taken in good faith. ___ (1) No suit, prosecution or other legal 
proceedings shall lie against any person for anything wh ich is done in good faith or intended to be 
done in pursuance of the provisions of this Act or rules made there under. 
 
 (2) No suit or other legal proceedings shall lie against the Federal Government for any 
damage caused or likely to be caused for anythi ng which is done with due care in good faith or 
intended to be done in pursuance of the provisions of this Act. 
 
 17. Power to make rules. ___ The Federal Government may, by notification  in the official 
Gazette, make rules for carrying out the purposes of this Act. 
 
 18. Removal of difficulties.___ If any difficulty arises in giving effect to any provision of this 
Act, the President may make such order as he considers necessary or expedient for the purpose of 
removing the difficulty. 
__________