Updated: Monday April 28, 2014/AlEthnien
Jamada El Thaniah 28, 1435/Somavara
Vaisakha 08, 1936, at 11:53:40 AM
[1][1]The Transplantation of Human Organs and Tissues Act,
2010
(Act
VI of 2010)
[18
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 matters 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 [2][2][the
(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;
[3][3][(dd) “Government” means Government of the
(e) “human organ” mean 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
worth but does 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;
(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, genuinely 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.– (l) 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 donor 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 human 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.
5. Evaluation Committee.– (l) As soon as may be after the
commencement of this Act the [4][4][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.– (l) 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 medically 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 permanent cessation of all
brainstem 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 [5][5][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 surgery in
transplantation of human organs and tissues. The [6][6][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 appropriate
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.– [7][7][(1)
The Government shall, by notification in the official Gazette, constitute a
Monitoring Authority consisting of the following:---
(i) |
Minister for Health or a nominee of the
Chief Minister; |
Chairperson |
(ii) |
Secretary
to the Government, Health Department; |
Member/Secretary |
(iii) |
Secretary
to the Government, Home Department or his representative not below the rank
of Additional Secretary; |
Member |
(iv) |
President,
Transplantation Society of Pakistan or his nominee; |
Member |
(v) |
Executive
Director Pakistan Medical Research Council or his nominee; |
Member |
(vi) |
President,
Ophthalmologic Society of Pakistan or his nominee; |
Member |
(vii) |
President, Pakistan Medical Association of Pakistan or
his nominee; |
Member |
(viii) |
President,
Pakistan Society of Gastroenterology or his nominee; |
Member |
(ix) |
Surgical
Transplant Specialist nominated by the Government; |
Member |
(x) |
Chairperson
of the Punjab Health Care Commission or a nominee of the Health Care
Commission; and |
Member |
(xi) |
any other outstanding Medical Specialist
nominated by the Government. |
Member] |
(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;
(c) inspect recognized medical institutions and hospitals
for examination of quality of transplantation, 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 human 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 [8][8][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 [9][9][Government] shall provide a reasonable annual grant.
(4) The
[10][10][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 transplantation or indigent
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 organ 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 shall 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;
(b) seeks to find a person willing to supply for
payment of any human organ;
(c) offers to supply any human organ for payment;
(d) initiates or negotiates any arrangement
involving the making of any payment for the supply of, or for an offer to
supp1y 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 distributed 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
registration 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 incharge of,
and was responsible to, the company for the conduct of business of the company,
as well as the Company, shall be deemed to be guilty of the 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
contained 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 any body corporate and
includes a firm or other association of individuals; and
(b) “director”, in relation to a firm, means a
partner in the firm.
14. Cognizance of offences.– (l) No Court inferior to that of
the Magistrate of First Class empowered under section 30 of the Code of
Criminal 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 any 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 which is done in
good faith or intended to be done in pursuance of the provisions of this Act or
rules made thereunder.
(2) No
suit or other legal proceedings shall lie against the [11][11][Government] for any damage caused or likely to be caused
for anything 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 [12][12][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 [13][13][Government] may make such order as [14][14][it]
considers necessary or expedient for the purpose of removing the difficulty.
[1][1]This
Act of Majlis-e-Shoora
(Parliament) received the assent of the President on the 17th March,
2010, and published in the Gazette of Pakistan (Extraordinary), dated 18th
March 2010, pp.89-96.
This
Act was originally in the Federal ambit, however, the subject on which this law
was enacted, devolved to the provinces by virtue of 18th Amendment
in the Constitution, hence it was adopted, with amendments, for the province of
the Punjab by the Punjab Transplantation of Human Organs
and Tissues (Amendment) Act 2012 (LVII of
2012) w.e.f. 1st November 2012.
[2][2]Substituted for the word “
[3][3]Inserted ibid.
[4][4]Substituted for the words “Federal Government” by the Punjab Transplantation of Human Organs and Tissues (Amendment) Act 2012 (LVII of 2012).
[5][5]Substituted for the words “Federal Government” by the Punjab Transplantation of Human Organs and Tissues (Amendment) Act 2012 (LVII of 2012).
[6][6]Ibid.
[7][7]Substituted by
the
[8][8]Substituted ibid., for the words “Federal Government”.
[9][9]Substituted for the words “Federal Government” by the Punjab Transplantation of Human Organs and Tissues (Amendment) Act 2012 (LVII of 2012).
[10][10]Ibid.
[11][11]Substituted for the words “Federal Government” by the Punjab Transplantation of Human Organs and Tissues (Amendment) Act 2012 (LVII of 2012).
[12][12]Ibid.
[13][13]Ibid for the word “President”.
[14][14]Ibid
for the word
“he”.
Go to Index
| LL. B. – I | LL. B. – II
| LL. B. – III | LL. B.
Directory | Home