TRANSPLANTATION OF
HUMAN ORGANS AND TISSUES ACT,2010
( VI OF 2010)
[18th
March, 2010]
Part I
Acts, Ordinances, President’s Orders and
Regulations SENATE SECRETARIAT
No. F. 9(1)/2009- Legis.–– The following
Act of Majlis-e-Shoora (Parliament) received the assent of the President on
17th March, 2010, is hereby published for general information:––
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.
(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 brain stem;
(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 ;
2[( dd)
“Government” means Government of the Punjab];
(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
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.–– (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 recognised 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.–– (1) As soon as may be after the commencement of this Act the 3[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 leaving a good record of
social service. The Evaluation Committee shall be established for every
recognized 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;
3
(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 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
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[2]
[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 5[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.–– 6[(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 Chairperson
Minister;
(ii)
Secretary to the Government, Member/Secretary
Health Department;
(iii)
Secretary to the Government, Member
Home Department or his representative
not below the rank of Additional Secretary;
(iv)
President, Transplantation Society of Pakistan
or his Member
6
nominee;
(v)
Executive Director, Pakistan Medical Research Member Council or his nominee;
(vi)
President, Ophthalmologic Society of Pakistan or
his Member nominee;
(vii)
President Pakistan Medical Association of
Pakistan Member or his nominee
(viii)
President, Pakistan Society of Gastroenterology
or Member his nominee;
(ix)
Surgical Transplant Specialist nominated by the Member Government; and
(x)
Chairperson of the Punjab Health Care Commission
Member or a nominee of the Health
Care Commission;
(xi)
any other outstanding Medical Specialist
nominated Member] by the
Government.
(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 xenotransplantation 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
[3][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 8[Government]
shall provide if reasonable annual grant.
(4)
The 9[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
9
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 he reported to the 10[the Punjab] Medical
and Dental Council for appropriate action including removal of' his name from
the register of 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; 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
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,–
10
(a)
"company" means any body corporate and
includes a firm or other
association of individuals; and
(b)
"director", in relation to a firm, means it
partner in the firm.
14.
Cognizance
of' offences.–– (1) 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 32of the Code of
Criminal
Procedure, 1898 (Act V of 1898) it shall be lawful for a
Magistrate referred to in subsection(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 or 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 297of the Pakistan Penal Code (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 there under.
(2)
No suit or other legal proceedings shall lie against
the [4][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 [5][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 [6][Government]
may make such order as [7][it]
considers necessary or expedient for the purpose of removing the difficulty.
[1] Substituted by the Punjab
Transplantation of Human Organs and Tissues (Amendment) Act 2012 ( LVII of
2012) 2 Inserted by the Punjab Transplantation of Human Organs and
Tissues (Amendment) Act 2012 ( LVII of 2012)
[2] Substituted by the Punjab
Transplantation of Human Organs and Tissues (Amendment) Act 2012 ( LVII of
2012) 5 Substituted by the Punjab Transplantation of Human Organs
and Tissues (Amendment) Act 2012 ( LVII of 2012)
[3] Substituted by the Punjab
Transplantation of Human Organs and Tissues (Amendment) Act 2012 ( LVII of
2012) 8 Substituted by the Punjab Transplantation of Human Organs
and Tissues (Amendment) Act 2012 ( LVII of 2012)
[4] Substituted by the Punjab
Transplantation of Human Organs and Tissues
(Amendment) Act 2012 ( LVII of 2012)
[5] Substituted by the Punjab
Transplantation of Human Organs and Tissues
(Amendment) Act 2012 ( LVII of 2012)
[6] Substituted by the Punjab
Transplantation of Human Organs and Tissues
(Amendment) Act 2012 ( LVII of 2012)
[7]
Substituted by the Punjab Transplantation of Human Organs and Tissues (Amendment) Act 2012 ( LVII of 2012)
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