Human Body Organ Transplantation (Regulation and Prohibition) Act, 2055 (1998)


Published: 1998

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Human body organ transplantation act
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The H uman B ody O rgan Transpl antation (Regulation and Prohibition)
Act, 2055 (1998)
Date of Authentication 2055.10.21 (Feb. 3, 2002)
Act num be r 20 of the year 2055(1998)
An Ac t made to provi de for the Transpl antation of Human Body O rgan
Pream ble: Whereas, it is expedient to make provis ions regulat ing the
act ivit ies perta inin g to the extraction of an organ from the human body for
the purpose of trea ting a d isease in a systemat ic manner in accordance w ith
the modern medica l trea tment and extrac t ion of an organ from the body of a
human be ing and transplantat ion of tha t organ into the body of another
human be ing and pre venting act ivit ies re lat ing to the purchase and sa le of
human body organ and use of the same in other purposes;
Be it enacted by Par liament in the twenty se venth re ign of H is
Ma jesty K ing Birendra Bir Bikram Shah Dev.
Chapter-1
Sh ort ti tle an d c ommencement
1. Short ti tle and c ommencement: (1) This Act may be ca lled as the
“Human Body Organ Transplanta t ion (Regula tion and Prohib it ion)
Act, 2055 (1998).”
(2) This Act sha ll come into force on such da te as the
Government of Nepa l may appoint, by a not ificat ion in the Nepal
Gazette.
2. Definitions: Unless the subject or the context otherwise requires, in
this Ac t:
(a) "human body" means the body of al ive or dead human be ing.
(b) "organ" means any organ of the human body and th is erm a lso
inc ludes a t issue of the human body.

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(c) “organ transplanta tion” means the transplanta t ion of an organ
of one human body into another human body for the purpose of
trea t ing a d isease in a managed manner in accordance with the
modern medica l system.
(d) “act ivity rela ting to organ t ransplantat ion” means an act ivity to
extract an organ from the human body for the purpose of
trea t ing a d isease in a managed manner in accordance with the
modern medica l system, to sa fe ly store the organ so extrac ted
or transplant it into another human body by fol low ing the
scient if ic technology and method.
(e) “hea lth inst itut ion” means a hea lth inst itut ion having obtained
the permit to operate the ac tivity relating to organ
transplantat ion pursuant to th is Act.
(f) “permit” means the permit to be issued pursuant to Sect ion 5 to
operate the act ivity re la t ing to organ transplantation.
(g) “pr iva te license” means the license to be issued pursuant to
Sub-sect ion (1) o f Sect ion 8 to operate the ac t ivity re lat ing to
organ transplantat ion.
(h) “doc tor” means a doctor in possession of the qualificat ion as
refe rred to in Sub-section (2) of Section 8.
( i) "commit tee" means an organ transplantat ion coordinat ion
commit tee constitu ted pursuant to Sec t ion 12.
( j) “donor” means a person who gives consent in wr it ing to dona te
an organ pursuant to Section 15 for purposes of Sect ion 14.
(k) “organ rece iving person” means a person who rece ives the
organ donated by a donor pursuant to this Act.
( l) “close re lat ive”, in respec t o f any person, means that person’s
son, daughter, mother, father, brothe r, sis ter, uncle, nephew,
n iece, grand- father, grand-mother from the father’ s s ide, grand-

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son, grand-daughter from the son’s s ide, grand-son, grad-
daughter from the daughter’s side, and includes husband, w ife,
adopted son, adopted daughter, step mother, step father, fa ther-
in- law, mother- in- law, which whom re lat ionship has constant ly
exis ted s ince two years ago.
(m) “As prescribed" means prescribed in the Rules framed under
this Ac t.
Chapter-2
Pe rmit rel ating to organ t ransplantati on and private license
3. Prohibition on ope ration of activi ty relating to organ
tran splantation without obtaining pe rmit: No person shall opera te
or cause to be opera ted the act ivity re lat ing to organ transplantat ion
without obta ining the perm it pursuant to this Ac t.
4. Application for pe rmit: Any person, other than a go vernmental
hospita l prescr ibed by the Go vernment of Nepal upon a ot ificat ion
published in the Nepal Gazette, has to make an application,
accompanied by the fees as prescribed, to the commit tee, in the
format as prescr ibed, to operate the act ivity re la ting to organ
transplantat ion.
5. Issu ance of pe rmit: (1) Where an applica t ion is made pursuant to
Sec t ion 4, the commit tee sha ll complete the prescr ibed procedures
and issue the perm it to the applicant in the prescribed format.
(2) Such physical means, human resource and othe r necessary
services as required to be arranged by the concerned applicant in
order to obtain the permit pursuant to Sub-sect ion (1) sha ll be as
prescr ibed.

6. Prohibition on ope ration of activi ty relating to organ
tran splantation with out obtaining private license: No person shall

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operate the act ivity relat ing to organ transplanta tion without
obta in ing the pr iva te license pursuant to this Ac t.
7. Application for private l icense: A doctor who in tends to opera te the
act ivity re la t ing to organ transplantat ion has to make an application,
accompanied by the fees as prescribed, to the commit tee, in the
format as prescr ibed, for the private license.
8. Issu ance of private l icense: (1) Where an applica tion is made
pursuant to Section 7, the commit tee shall comple te th prescribed
procedures and issue the pr iva te l icense to the applicant in the
prescr ibed format.
(2) Such qua lif icat ion as required to be possessed by the doc tor
in order to obta in the pr iva te license pursuant to Sub-sect ion (1) shall
be as prescr ibed.
9. Period and rene wal of pe rmit: (1) Except w here the perm it is
revoked ear lier pursuant to Sect ion 10, the per iod of the permit shall
remain va lid for a pe r iod of tw o years.
(2) Pr ior to the expirat ion of the per iod of permit, an
appl ication, accompanied by the fees as prescr ibed, has to be made by
the concerned hea lth inst itut ion to the commit tee, in the prescribed
format, for the renewal of the permit.
(3) Where an applica tion is made pursuant to Sub-sec t ion (2),
the committee sha ll comple te the prescribed procedur s and renew the
per iod of permit for up to two years each time.
(4) The perm it which is not renewed pursuant to Sub-sec tion (3)
sha l l i pso facto be re voked.

10. Revoc ation an d suspension of pe rmit and private license: (1) If a
hea lth inst itut ion and private license holder doctor acts in
contra vention of this Ac t or the rules framed under this Ac t or fai l to

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carry out the order and direc t ive issued by the commit tee pursuant to
Sec t ion 29, the commit tee may revoke or suspend the permit of such
hea lth institution and the private license of such doctor for a per iod
not exceeding s ix months.
(2) Prior to the re vocat ion or suspension of the prm it or
private license pursuant to Sub-sec t ion (1), the commit tee sha ll give a
reasonable oppor tunity to the concerned health institut ion or doctor
to furn ish explana t ion.
11. Appeal: (1) The hea lth institu tion or doctor who is not sa ti f ied w ith
the order issued by the committee pursuant to Sub-sec t ion (1) of
Sec t ion 10 may make an appea l to the M in istry of Hea lth of the
Government of Nepa l w ith in th irty f ive days a fter the issue of such
order.
(2) A dec ision made by the Min istry of Hea lth of the
Government of Nepa l on the appea l made pursuant to Sub-sec tion (1)
sha l l be f ina l.
Chapter-3
Organ t ransplantation c oordination c ommittee
12. Organ transpl antation coordin ation committee: (1) There sha ll be
formed an organ transplantat ion coord inat ion committee consist ing of
the cha irperson and member as fol lows in order to formulate pol icies,
p lans and programs on organ transplantat ion and submit the same to
the Go vernment of Nepa l, in addition to the per formance and exerc ise
of the other funct ions, dut ies and powers conta ined in th is Ac t :

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(a) Senior doctor nom ina ted by
the Government of Nepal Cha irperson
(b) Three doc tors nom ina ted by
the Government of Nepal

Member
(c) Representa t ive ( Gazetted
First Class), Minis try of
Health

Member
(d) Representa t ive, Minis try of
Law and Just ice

Member
(e) Representa t ive, Nepal
Medica l Counci l Member
(f) Representa t ive, Nepal
Medica l Associat ion Member
(g) Director Genera l, Depar tment
of Health Services Member secre tary
(2) The term of o ff ice of the chairperson and members
nom inated pursuant to Clauses (a) and (b) o f Sub-section (1) sha ll be
two years; and, after expira tion of their term, they may be re-
nom inated.
(3) The Go vernment of Nepa l may, if it considers necessary,
make necessary a ltera tion or change in respect of the members of the
commit tee as re ferred to in Sub-sec t ion (1).
(4) The committee may, if it considers necessary, in vite any
expert or ad visor to a ttend its meet ing, as an obser ver.
(5) The procedures on the meet ing of the committee sha ll be as
dete rm ined by the commit tee on its ow n.
(6) The Government of Nepa l shall provide such budge t as may
be required for the commit tee.

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(7) The meet ing allowance and other facilit ies of the
cha irperson and members of the committee sha ll be as prescribed.
(8) The secretaria t of the commit tee shall be located at the
Department of Hea lth Services, the Go vernment of Nepa l.
Chapter-4
Activity relating to organ t ranspl antation
13. Prohibition on operating acti vi ty rel ating to organ
tran splantation : No person sha ll operate an ac t ivity re lat ing to organ
transplantat ion for the purpose of the sa le and purchase of an organ
or s imilar other ac ts.
14. Extraction of organ and tran splantation of organ c an be done:
Subjec t to the other pro vis ions contained in th is Act, an organ can be
extracted from the human body and an organ can be extracted from
the body of a human be ing and transplanted in to the body of another
human be ing only for the purpose of trea ting a d isease in a managed
manner in accordance w ith the modern medical treatment system.
15. Organ can be extracte d f rom body of alive pe rson: (1) Subject to
the other condit ions mentioned in th is Ac t, an organ may be extracted
from the body of an a live person (donor) and such organ may be
transplanted into the body of a c lose re la t ive of that donor only in the
follow ing circumstances:
(a) Where it is cert ified by a t least two concerned
doc tors tha t a bodily organ of any patient is
deformed to be unworkable and it is necessary to
transplant another organ in lieu of his /her deformed
bodily organ in order to save the life of such
pat ient,
(b) Where a close re la t ive (donor ) o f the patient as
refe rred to in Clause (a) has voluntarily given

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consent in writ ing to dona te the organ, along w ith
the concur rence of at least two of h is/her re lat ives,
Pro vided tha t, if any donor has not two close
rela t ives, consent in writ ing may be given
vo luntarily to dona te the organ, along with the
concurrence of even one close re lat ive.
(c) Where the donor giving consent vo luntar ily to
donate the organ pursuant to Clause (b) has
comple ted the age of eighteen years,
(d) Where it is cert ified by a t least two concerned
doc tors that the donor giving consent to dona te an
organ pursuant to Clause (b) w ill neither d ie
immediate ly and nor become disabled or
incapac itated in a permanent manner as a result of
extract ion of any organ out o f the tw in organs of the
body of that donor,
(e) Where it is cert ified by a t least two concerned
doc tors that the t issue intended to be extracted from
the body of the donor can re-grow.
(2) Subject to the other condit ions mentioned in this Ac t, where
it is cert if ied by at least two concerned doctors that any tissue can re-
grow in the body of a person who has not completed he age of
e ighteen years, th is Sect ion shall not be deemed to bar the extract ing
of tha t tissue from the body of such person.
(3) This Section sha l l not be deemed to bar the extract ing of
any unworkable organ from the body of any person and throwing
away of such organ, in the course of treatment.
(4) The procedures on giving consent and concur rence pursuant
to Clause (b) or Sub-sect ion (1) sha ll be as prescribed.

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(5) If the donor so wishes, he/she may withdraw the consent
given pursuant to Clause (b) or Sub-sec tion (1).
(6) If the donor w ithdraws the consent pursuant to Sub-sect ion
(5), the person receiving the organ shall not be ent it led to c laim any
k ind of compensa t ion against the donor.
16. Organ can be extracte d f rom body of deceased: (1) Subjec t to the
other condit ions mentioned in this Act, an organ may be extracted
from the body of a deceased or the organ so extracted may be
transplanted in to the body of another person only in the fo llowing
c ircumstances:
(a) Where it is cert ified by a t least two concerned
doc tors that the person from whose body the organ
is to be extracted has already died a brain death,
(b) Where the person who w ishes to donate h is/her
organ after death for purposes of Sect ion 14 has
vo luntarily given an informed consent in wr iting.
(2) The other procedures on giving consent and concurrence
pursuant to Clause (b) or Sub-section (1) sha ll be as prescr ibed.
17. Prohibition on t ransplantation of bodi ly organ of dece ase d:
Notwithstanding anything conta ined in Sec t ion 16, no organ sha ll be
extracted from the body of any deceased and transplanted in to
another human body in such a manner as to affec t the post mortem of
tha t person who d ied as a result of murder or suic ide or in a doubtful
c ircumstance.
Pro vided that, th is Sec tion sha ll not be deemed to ba r the
extract ing of an organ for the post mor tem of such deceased or for
any other research purpose.
18. To make aware about possible ri sk: While extract ing and
transplant ing an organ pursuant to this Act, the doctor sha ll examine

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the hea lth of the donor and the recip ient o f organ and inform both
part ies about the possible e ffects and r isks tha t cn be caused
therefrom on or to the ir hea lth.
19. Requi rement of c onsent of reci pient of organ: (1) In transplant ing
an organ pursuant to th is Ac t, the consent of the recip ient of organ
sha l l a lso be required.
(2) Where the rec ipient of organ is a m inor and incapac itated to
make dec ision, the c lose re lat ive may give such consent on beha lf of
such recip ient.
20. Transplantation organ with out consent : Notwithstanding anything
contained in Sec t ion, an organ may be t ransplanted even without
consent of the rec ipient of organ in the fo llowing c ircumstances:
(a) Where the recip ient o f organ is in unc laimed situation,
(b) Where it is not possib le to in form the close rela tive of the
rec ipient of organ obtain consent in due t ime,
(c) Where it is possib le that such person can d ie if the organ
is not transplanted immediately in the c ircumstances as
refe rred to in Clauses (a) and (b).

21. Cost expen diture and se rvice c harge: In transplant ing an organ
pursuant to th is Act, a health inst itution may collect the cost
expenditure and service charge from the rec ipient of organ.
Pro vided that :
(a) The ra te of such ser vice charge has to be approved
by the commit tee.
(b) The rate of such ser vice charge has to be published
as d irected by the committee.
(c) The ra te of such service charge has to be proper and
reasonable.

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22. Tec hnical matters to be fol lo we d in extractin g or t ransplanting
organ: The technica l matters rela ting to modern medical scien es
required to be fo llowed in extract ing an organ or safe ly storing an
extracted organ or transplant ing an organ pursuant to th is Act sha ll be
as prescr ibed.
Chapter-5
Offense an d Punishment
23. Offense relatin g to organ tran splantation : I f a person extrac ts any
organ of another person or transplant the organ so extracted in to
another person or uses it in another work or is d irect ly involved in
such act does any other act in contravent ion of the circumstances
mentioned in Sect ions 13, 14, 15, 16 and 17, such person sha ll be
deemed to ha ve commit ted the offense as re ferred to in this Act.
24. Punishment: (1) A person who commits an offense as re ferred to in
Sec t ion 23 sha ll be punished with impr isonment for a term not
exceeding f ive years and a f ine not exceeding five hundred thousand
rupees.
(2) A person w ho commits an offense as re fer red to in Sect ion
23 in any place other than a hea lth institut ion shall be punished w ith
imprisonment for a term not exceeding one year and a f ine of one
hundred thousand rupees, in addition to the punishment to be imposed
pursuant to Sub-sect ion (1).
(3) Where a person who has not got the private license commits
an offense as referred to in Sect ion 23 in any place other than a
hea lth institut ion, such person sha l l be punished with impr isonment
for a term not exceeding two years and a fine of two hundred
thousand rupees, in addition to the punishment to be imposed
pursuant to Sub-sect ion (1).

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(4) Where an offense as re ferred to in Sec tion 23 and the person
from w hom an organ is extracted dies as a result o f that wound or
pain w ith in three months, the person who commits such offense shall
be punished w ith life impr isonment, w ith confisca t ion of ent ire
proper ty.
(5) A person who does an act ivity re lat ing to organ
transplantat ion in contravent ion of the provis ions contained in th is
Act other than Sub-sec t ions (1), (2), (3) and (4) or the ru les framed
under this Act shall be punished with impr isonment for a term not
exceeding One year and a f ine not exceeding O ne Hundred Thousand
Rupees.
25. Punishment for attempt: In cases where all prepara t ion has been
made to commit an offense as re ferred to in Sec tion 23 but the
offense has not yet been committed, it sha ll be deem d at tempt to
commit such offense, and such person sha ll be punished w ith ha lf the
punishment as referred to in Sect ion 24.

26. Punishment to Acc omplice: Except to be in vo lved d irect ly in the
act ivity to be offence pursuant to Sec t ion 23, any person assist ing to
commit such offence shall be deemed as accomplice and the
accomplice sha ll be punished w ith ha lf punishment to tha t of
o ffender.
27. Prohibition on adve rtisement an d publici ty: (1) No one sha ll do
and publ icize, or cause to be done or publ ic ized, direct ly or indirec t ly
through communicat ion media as to that an organ can be provided or
is necessary.
Pro vided that, th is Sec tion sha ll not be deemed to ba r the
d issem ina ting of re lated in format ion with a view to provid ing
technical knowledge about organ transplanta t ion.

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(2) The communicat ion agency, publisher and editor publ ish ing
an ad vert isement and broadcasting inst itu tion and transm it ter in
contra vention of Sub-sect ion (1) may be punished by the prescribed
author ity w ith a f ine not exceeding Twenty Five Thousand Rupees.
(3) One who is not satis fies w ith the f ine imposed by the
prescr ibed author ity pursuant to Sub-sec tion (2) may f ile an appeal
before the Cour t o f Appea l w ith in th irty f ive days after the date of
knowledge of such f ine.
Chapter-6
Miscel laneou s
28. Inspection: (1) The author ity authorized by the commit tee may
inspect as to whe ther the health inst itut ion and doctor holding the
private license ha ve observed pursuant to th is Act or he ru les framed
hereunder and the orders and direc t ives given pursuant to Sect ion 29
in operat ing the ac tivity re lat ing to organ transplanta t ion.
(2) The author ity who carr ies out inspection pursuant to Sub-
sect ion (1) sha ll have to subm it a report on inspect ion carr ied out by
h im /her to the committee.
29. Powers to give orde r an d di rective: (1) In cases where the
competent author ity has ca rried out inspect ion pursuant to Sect ion 28
or in any other s itua t ion whatsoever, the commit tee may give
necessary order and direct ion to the hea lth inst itution and the doctor
having obta ined the pr iva te license in respect o f the operat ion of
act ivity re lat ing to organ transplanta tion.
(2) In givin g necessary d irection and order pursuant to Sub-
sect ion (1), the commit tee shal l do so part icu lar ly on the fo llowing
matters:

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(a) Technica l matter required to be fo llowed in
transplant ing organ in accordance w ith the
princip les of medica l sc iences.
(b) Such physica l means, resources and human
resources as required in transplanting organ.
(c) Safe ly stor ing an organ extracted from a human
body for organ t ransplantation in accordance with
scient if ic technique and method.
(d) Min imum sa fety pro vis ions required to be followed
in transplant ing organ.
(e) D issem ina tion of in format ion on technical matters
rela t ing to organ transplantat ion.
(3) It sha ll be the duty of the concerned health inst tu t ion and
doc tor ha vin g obta ined the pr iva te license to carry out, or cause to be
carr ied out, the order and direc t ive given by the commit tee pursuant
to Sub-sec tion (2).

30. No compul sion to make de position: The health inst itu t ion or the
doc tor ha vin g obta ined the pr iva te license or any person rela ted w ith
such inst itu t ion or doctor sha ll not be compelled to make deposit ion
before any one other than the author ity author ized by the preva il ing
law in respec t o f the ac t ivity rela ting to organ transplantat ion opera te
by such inst itu t ion or doctor or person pursuant to th is Ac t.
31. Annual report: (1) Each health inst itu tion sha ll have to prepare
desc ription of the ac ts done pursuant to th is Act in respec t o f the
act ivity re lat ing to organ transplantat ion in the prescribed format and
submit the same to the committee each year.
(2) The committee shall submit a report, a long with its
eva lua t ion as to the repor t submitted by the hea lth inst itut ion

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pursuant to Sub-sect ion (1) and the polic ies and programs to be
adopted by the Go vernment of Nepal in respect thereof, to the
Government of Nepa l each year.
32. Government to be the Plainti ff: The cases under this Act sha ll be
f iled as Go vernment cases; and these cases sha ll be deemed to be
inc luded in Schedule-1 of the Go vernment Cases Act, 2049 (1992).
33. Liai son Ministry: The Commit tee sha ll make contact w ith
Government of Nepa l through the Min is try of Health.
34. Powers to frame Rules: The Government of Nepa l may frame
necessary Rules in order to implement the objec tives of th is Act.