The H uman B ody O rgan Transpl antation (Regulation and Prohibition) Act, 2055 (1998)
Date of Authentication 2055.10.21 (Fe b. 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 e xpedie nt to make provisions regula ting the activities perta inin g to the extraction of an organ from the huma n body for the purpose of trea ting a disease in a systematic manner in accorda nce w ith the modern me dica l trea tment and extrac tion of an organ from the body of a hum an be ing and tra nsplantation of tha t orga n into the body of another hum an be ing and pre venting activitie s re lating to the purchase and sa le of hum an body organ and use of the same in other purposes; Be it enacte d by Parliament in the twenty se venth re ign of H is Ma jesty K ing Bire ndra Bir Bikram Shah De v.

Chapter-1
Sh ort title an d c ommencement

1. Short title and c ommencement:

(1) This Act m ay be ca lle d a s the â€œHuman Body Organ Tra nsplanta tion (Re gula tion and Prohibition)
Act, 2055 (1998).”
(2) This Act sha ll c ome into force on such da te a s the Governme nt of Nepa l may appoint, by a notification in the Nepal Gazette.

2. Definitions:

Unle ss the subject or the context otherwise require s, in this Ac t:
(a) “human body” mea ns the body of alive or dead human be ing.
(b) “organ” means any orga n of the huma n body and this term a lso inc lude s a tissue of the human body.
(c) “organ transplanta tion” means the tra nsplanta tion of a n organ of one huma n body into another human body for the purpose of trea ting a disea se in a ma naged ma nner in accordance with the
modern medica l system.
(d) “activity rela ting to organ transpla ntation” mea ns an activity to extract a n organ from the huma n body for the purpose of trea ting a disea se in a ma naged ma nner in accordance with the modern medica l system, to sa fe ly store the organ so e xtrac ted or tra nsplant it into a nother human body by follow ing the scie ntific technology and me thod.
(e) “hea lth institution” mea ns a hea lth institution ha ving obtained the permit to operate the ac tivity relating to organ transplantation pursuant to this Act.
(f) “permit” means the permit to be issued pursua nt to Section 5 to operate the activity re la ting to orga n transpla ntation.
(g) “priva te lice nse” means the lic ense to be issue d pursua nt to Sub-section (1) of Section 8 to operate the ac tivity re lating to orga n transplantation.
(h) “doc tor” means a doctor in posse ssion of the qualific ation as refe rred to in Sub-section (2) of Section 8.
(i) “comm ittee” means a n organ transplantation c oordination committee c onstitute d pursua nt to Sec tion 12.
(j) “donor” means a person who gives conse nt in writing to dona te an orga n pursua nt to Section 15 for purpose s of Section 14.
(k) “organ rece iving person” means a person who rece ive s the orga n donated by a donor pursua nt to this Act.
(l) “close re lative”, in respec t of a ny pe rson, means that person’s son, daughter, mother, father, brothe r, sister, unc le, ne phew, niec e, gra nd-father, grand-mother from the father’s side, gra nd- 3 son, gra nd-daughter from the son’s side, grand-son, gra ddaughter from the daughter’s side, and include s husba nd, wife, adopted son, a dopted da ughter, ste p mother, ste p father, fa therin-law, m other-in-law, which whom re lationship has constantly existed since two years a go.
(m) “ As prescribed” mea ns prescribed in the Rules fra med under this Ac t.

Chapter-2
Pe rmit rel ating to organ transplantati on and private license

3. Prohibition on ope ration of activity relating to organ tran splantation without obtaining pe rmit:

No person shall opera te or cause to be opera ted the activity re lating to orga n transplantation
without obta ining the perm it pursua nt to this Ac t.

4. Application for pe rmit:

Any person, other than a go vernmental hospita l pre scribe d by the Go vernme nt of Nepal upon a notification published in the Nepal Gazette, has to make an applic ation, accompanie d by the fe es as prescribed, to the c ommittee, in the forma t as pre scribe d, to operate the activity re la ting to organ
transplantation.

5. Issu ance of pe rmit:

(1) Where a n a pplica tion is made pursua nt to Sec tion 4, the comm ittee sha ll complete the pre scribe d procedures and issue the perm it to the applicant in the pre scribed format.
(2) Such physical means, huma n re sourc e a nd othe r necessary service s as required to be arra nged by the c oncerned a pplicant in orde r to obtain the permit pursua nt to Sub-section (1) sha ll be as prescribe d.

6. Prohibition on ope ration of activity relating to organ tran splantation with out obtaining private license:

No person shall  operate the activity relating to orga n transpla nta tion without obta ining the priva te license pursua nt to this Ac t.

7. Application for private license:

A doctor who intends to opera te the activity re la ting to organ transplantation ha s to make an applic ation, accompanie d by the fe es as prescribed, to the c ommittee, in the forma t as pre scribe d, for the private lic ense.

8. Issu ance of private license:

(1) Where an applica tion is ma de pursuant to Section 7, the c ommittee shall c omple te the prescribed
proc edure s and issue the priva te license to the applicant in the prescribe d format.
(2) Such qua lification a s re quire d to be possessed by the doc tor in order to obta in the priva te lic ense pursua nt to Sub-section (1) shall be as pre scribe d.

9. Period and rene wal of pe rmit:

(1) Except w here the perm it is revoke d earlier pursuant to Section 10, the period of the permit shall
remain va lid for a pe riod of tw o yea rs.
(2) Prior to the expiration of the period of permit, an application, ac com pa nie d by the fee s as prescribed, has to be made by the concerne d hea lth institution to the c ommittee, in the prescribed
forma t, for the renewal of the permit.
(3) Where a n applica tion is made pursuant to Sub-sec tion (2), the comm ittee sha ll c om ple te the prescribed proce dures and re new the period of permit for up to two years each time.
(4) The perm it which is not renewe d pursuant to Sub-sec tion (3) sha ll i pso facto be re voked.

10. Revoc ation an d suspension of pe rmit and private license:

(1) If a hea lth institution a nd private license holder doctor acts in contra vention of this Ac t or the rules frame d under this Ac t or fail to  carry out the order a nd direc tive issue d by the comm ittee pursua nt to Sec tion 29, the comm ittee may revoke or suspe nd the permit of such hea lth institution and the private lice nse of such doctor for a period not exceeding six months.
(2) Prior to the re vocation or suspension of the perm it or private license pursua nt to Sub-sec tion (1), the comm ittee sha ll give a reasona ble opportunity to the concerned health institution or doctor
to furnish expla na tion.

11. Appeal:

(1) The hea lth institution or doctor who is not sa tisfied w ith the order issue d by the com mitte e pursuant to Sub-sec tion (1) of Sec tion 10 may ma ke an appea l to the M inistry of Hea lth of the
Governme nt of Nepa l w ithin thirty five days a fter the issue of such orde r.
(2) A dec ision ma de by the Ministry of Hea lth of the Governme nt of Ne pa l on the appea l made pursuant to Sub-sec tion (1) sha ll be fina l.

Chapter-3
Organ transplantation c oordination c ommittee

12. Organ transpl antation coordin ation committee:

(1) There sha ll be forme d an orga n transplantation coordination c ommittee c onsisting of the cha irperson and member as follows in order to form ulate policie s, pla ns and programs on organ transpla ntation a nd subm it the same to the Go ve rnment of Nepa l, in a ddition to the pe rformanc e a nd exerc ise of the other functions, duties a nd powers conta ine d in this Ac t:
(a) Se nior doctor nom ina te d by the Governme nt of Nepal Cha irperson
(b) Thre e doc tors nom ina te d by the Governme nt of Nepal Member
(c) Re pre senta tive ( Gazette d First Class), Ministry of Health Member
(d) Re pre senta tive, Ministry of Law and Justice Member
(e) Re pre senta tive, Nepal Medica l Council Member
(f) Re pre senta tive, Nepal Medica l Association Member
(g) Dire ctor Genera l, Departme nt of Health Service s Member secre tary
(2) The term of office of the c hairperson and members nom inate d pursua nt to Clause s (a) a nd (b) of Sub-section (1) sha ll be two years; and, after expira tion of their term, the y may be renom inate d.
(3) The Go vernme nt of Nepa l may, if it considers nece ssary, make necessary a ltera tion or change in respect of the mem bers of the committee a s re ferre d to in Sub-sec tion (1).
(4) The c ommittee may, if it c onsiders nece ssary, in vite any expe rt or ad visor to a tte nd its me eting, as an obser ver.
(5) The proc edure s on the meeting of the committee sha ll be as dete rm ine d by the comm ittee on its ow n.
(6) The Government of Ne pa l shall provide such budge t a s may be require d for the c ommittee.
(7) The mee ting allowa nce and other fa cilit ies of the cha irperson a nd members of the c ommittee sha ll be a s prescribed.
(8) The secretaria t of the c ommittee shall be located at the Departme nt of Hea lth Services, the Go vernment of Nepa l.

Chapter-4
Activity relating to organ transpl antation

13. Prohibition on operating acti vity rel ating to organ tran splantation:

No person sha ll operate an ac tivity re lating to organ transplantation for the purpose of the sa le a nd purc hase of a n organ or similar other ac ts.

14. Extraction of organ and tran splantation of organ c an be done:

Subjec t to the other pro visions contained in this Act, a n orga n can be extracted from the human body and a n organ ca n be e xtracted from the body of a human be ing a nd tra nsplanted into the body of another hum an be ing only for the purpose of trea ting a dise ase in a managed manner in accorda nce w ith the m odern me dic al treatment system.

15. Organ can be extracte d from body of alive pe rson:

(1) Subject to the other conditions mentioned in this Ac t, a n organ may be e xtracted from the body of a n a live person (donor) and such organ ma y be transplanted into the body of a c lose re la tive of that donor only in the follow ing circumstance s:
(a) Where it is certifie d by a t least two concerned doc tors tha t a bodily organ of any patie nt is
deformed to be unworkable and it is necessary to transplant another orga n in lieu of his/her deformed
bodily organ in order to sa ve the life of such patient,
(b) Where a close re la tive (donor) of the patie nt as refe rred to in Clause (a) has voluntarily given
consent in writing to dona te the orga n, along w ith the concurrence of at lea st two of his/her re latives,
Pro vided tha t, if a ny donor has not two close rela tives, consent in writing ma y be given voluntarily to dona te the orga n, along with the conc urrence of eve n one close re lative.
(c) Where the donor giving c onsent voluntarily to donate the organ pursua nt to Cla use (b) has com ple te d the a ge of eighteen years,
(d) Where it is certifie d by a t least two concerned doc tors that the donor giving consent to dona te an
orga n pursuant to Clause (b) will neither die immediate ly and nor become disabled or inca pac itate d in a permane nt ma nner as a result of extraction of a ny organ out of the twin orga ns of the body of that donor,
(e) Where it is certifie d by a t least two concerned doc tors that the tissue inte nded to be e xtracted from
the body of the donor ca n re-grow.

(2) Subje ct to the other conditions mentioned in this Ac t, where it is certifie d by at least two concerne d doctors that any tissue can regrow in the body of a person who ha s not completed the a ge of e ighteen years, this Section shall not be deemed to bar the extracting of tha t tissue from the body of such person.
(3) This Section sha ll not be deemed to bar the extracting of any unworkable orga n from the body of a ny person and throwing away of suc h orga n, in the course of treatme nt.
(4) The proc edure s on giving consent and c oncurrence pursuant to Cla use (b) or Sub-section (1) sha ll be a s pre scribed.
(5) If the donor so wishe s, he/she m ay withdraw the consent give n pursua nt to Cla use (b) or Sub-sec tion (1).
(6) If the donor w ithdraws the c onsent pursuant to Sub-section (5), the person receiving the organ shall not be e ntitle d to c laim any kind of c ompensa tion against the donor.

16. Organ can be extracte d from body of deceased:

(1) Subjec t to the other c onditions mentioned in this Act, an organ ma y be e xtracted from the body of a decease d or the organ so extracte d ma y be transplanted into the body of a nother person only in the following c irc umsta nce s:
(a) Where it is certifie d by a t least two concerned doc tors that the person from whose body the organ
is to be e xtracte d has alrea dy die d a brain death,

(b) Where the pe rson who w ishes to donate his/her orga n after death for purposes of Section 14 has voluntarily give n a n informed consent in writing.
(2) The other proce dures on giving conse nt and conc urrence pursuant to Clause (b) or Sub-section (1) sha ll be as pre scribe d.

17. Prohibition on transplantation of bodily organ of dece ase d:

Notwithstanding a nything conta ine d in Sec tion 16, no organ sha ll be extracted from the body of a ny deceased and transplanted into another human body in such a m anner as to affec t the post mortem of
tha t person who died as a result of murder or suic ide or in a doubtful c irc umsta nce. Pro vided that, this Sec tion sha ll not be de emed to ba r the extracting of a n orga n for the post mortem of such decea sed or for any other re search purpose.

18. To make aware about possible ri sk:

While extracting and transplanting an orga n pursuant to this Act, the doctor sha ll exa mine  the hea lth of the donor a nd the recipient of organ and inform both parties a bout the possible e ffects a nd risks tha t ca n be ca used therefrom on or to the ir hea lth.

19. Requi rement of c onsent of reci pient of organ:

(1) In tra nsplanting an organ pursuant to this Ac t, the conse nt of the recipient of organ sha ll a lso be re quired.
(2) Where the rec ipie nt of organ is a m inor a nd inca pac itated to make dec ision, the c lose re lative may give suc h consent on beha lf of suc h recipie nt.

20. Transplantation organ with out consent:

Notwithstanding a nything contained in Sec tion, an organ may be transpla nted e ven without consent of the rec ipie nt of organ in the following c irc um sta nces:
(a) Where the recipie nt of orga n is in unc laimed situation,
(b) Where it is not possible to inform the close rela tive of the rec ipie nt of organ obtain c onsent in due time,
(c) Where it is possible that such person can die if the organ is not transpla nted immediately in the c ircum stanc es as refe rred to in Clauses (a) a nd (b).

21. Cost expen diture and se rvice c harge:

In transplanting an organ pursuant to this Act, a he alth institution may collect the c ost expe nditure and service charge from the rec ipie nt of organ. Pro vided that:
(a) The ra te of suc h ser vice charge ha s to be a pproved by the comm ittee.
(b) The rate of such ser vice c harge has to be published as directe d by the comm ittee.
(c) The ra te of suc h service charge has to be proper and reasona ble.

22. Tec hnical matters to be follo we d in extractin g or transplanting organ:

The technica l matters rela ting to modern medical sc iences require d to be followe d in extracting a n orga n or safe ly storing an extracted organ or tra nspla nting an organ pursuant to this Act sha ll be
as pre scribed.

Chapter-5
Offense an d Punishment

23. Offense relatin g to organ tran splantation:

If a person e xtrac ts any orga n of another person or tra nspla nt the organ so e xtracted into another person or uses it in another work or is directly involved in suc h a ct doe s any other act in c ontra ve ntion of the circumstances mentione d in Sections 13, 14, 15, 16 a nd 17, such person sha ll be deeme d to ha ve comm itted the offense as re ferred to in this Act.

24. Punishment:

(1) A person who comm its an offense as re ferred to in Sec tion 23 sha ll be punishe d with imprisonme nt for a term not exceeding five years and a fine not e xcee ding five hundred thousand rupe es.
(2) A person w ho comm its a n offe nse as re ferred to in Section 23 in any place other than a hea lth institution sha ll be punished w ith imprisonme nt for a term not excee ding one year a nd a fine of one
hundred thousand rupees, in addition to the punishme nt to be imposed pursuant to Sub-section (1).
(3) Where a person who ha s not got the private license comm its an offe nse a s referred to in Section 23 in a ny place other than a hea lth institution, such person sha ll be punished with im prisonment for a term not exce eding two years and a fine of two hundred thousa nd rupees, in addition to the punishme nt to be imposed pursuant to Sub-section (1).
(4) Where an offe nse as re ferred to in Sec tion 23 a nd the person from w hom an orga n is e xtra cte d dies as a re sult of that wound or pain w ithin three months, the person who c ommits such offense shall
be punished w ith life im prisonment, with confisca tion of entire property.
(5) A person who does an activity re lating to organ transplantation in contra ve ntion of the provisions contained in this Act other than Sub-sec tions (1), (2), (3) and (4) or the rule s framed under this Act shall be punishe d with imprisonment for a term not exceeding One year a nd a fine not excee ding O ne Hundre d Thousand Rupees.

25. Punishment for attempt:

In case s where all prepara tion has been made to comm it an offe nse as re ferre d to in Sec tion 23 but the offe nse has not yet been comm itted, it sha ll be deemed attem pt to commit such offe nse, a nd such person sha ll be punishe d w ith ha lf the punishme nt a s referre d to in Section 24.

26. Punishment to Acc omplice:

Exce pt to be in vo lve d directly in the activity to be offe nce pursua nt to Sec tion 23, any person a ssisting to commit suc h offence shall be deeme d as accomplice and the accomplice sha ll be punished w ith ha lf punishment to tha t of offe nder.

27. Prohibition on adve rtisement an d publicity:

(1) No one sha ll do and publicize, or cause to be done or public ized, dire ctly or indirec tly through com munication me dia as to that an organ can be provided or is nece ssa ry. Pro vided that, this Sec tion sha ll not be de emed to ba r the dissem ina ting of re late d information with a view to providing technical knowledge about organ tra nsplanta tion.

(2) The communic ation age nc y, publisher and editor publishing an ad vertiseme nt a nd broadca sting institution and transm itter in contra vention of Sub-section (1) m ay be punished by the prescribed
authority with a fine not exceeding Twenty Five Thousa nd Rupees.

(3) One who is not satisfie s with the fine im posed by the prescribe d a uthority pursuant to Sub-sec tion (2) may file an appeal before the Court of Appea l w ithin thirty five da ys after the date of knowle dge of such fine.

Chapter-6
Miscellaneou s

28. Inspection:

(1) The a uthority authorized by the c ommittee may inspect a s to whe ther the health institution and doctor holding the private license ha ve observed pursuant to this Act or the rule s framed here under a nd the orders and direc tive s give n pursuant to Section 29 in ope rating the ac tivity re lating to organ tra nsplanta tion.
(2) The a uthority who carrie s out inspection pursua nt to Subsection (1) sha ll ha ve to subm it a report on inspection carrie d out by him /her to the c ommittee.

29. Powers to give orde r an d di rective:

(1) In cases where the com petent authority has ca rrie d out inspection pursuant to Section 28 or in any other situa tion whatsoe ver, the comm ittee may give nece ssary order and direction to the hea lth institution a nd the doctor having obta ine d the priva te lic ense in respect of the operation of activity re lating to organ transplanta tion.
(2) In givin g necessary direction and orde r pursua nt to Subsection (1), the c ommittee shall do so particularly on the following matters:
(a) Technica l matter require d to be followe d in transplanting organ in acc orda nce w ith the principle s of me dica l sc iences.
(b) Suc h physica l means, re source s a nd human resources as required in tra nsplanting organ.
(c) Safe ly storing an orga n extracted from a human body for organ transpla ntation in accorda nce with
scie ntific technique a nd me thod.
(d) Minim um sa fety pro vis ions required to be followed in transplanting orga n.
(e) Dissem ina tion of informa tion on tec hnic al matters rela ting to organ transplantation.
(3) It sha ll be the duty of the c oncerned health institution and doc tor ha vin g obta ine d the priva te lice nse to carry out, or cause to be carried out, the order and direc tive give n by the comm ittee pursuant to Sub-sec tion (2).

30. No compul sion to make de position:

The health institution or the doc tor ha vin g obta ined the priva te license or a ny person rela ted w ith
suc h institution or doctor sha ll not be compelled to make de position before any one other than the a uthority authorize d by the pre va iling law in re spec t of the ac tivity rela ting to organ transplantation opera te by suc h institution or doctor or person pursuant to this Ac t.

31. Annual report:

(1) Each health institution sha ll ha ve to prepare desc ription of the ac ts done pursuant to this Act in respec t of the activity re lating to orga n transplantation in the prescribed forma t and submit the same to the com mitte e each year.
(2) The comm ittee shall submit a re port, a long with its e va lua tion as to the report submitted by the hea lth institution  pursuant to Sub-section (1) and the polic ies and program s to be adopted by the Go vernme nt of Nepal in respect thereof, to the Governme nt of Nepa l each year.

32. Government to be the Plaintiff:

The ca se s under this Act sha ll be file d a s Go vernme nt case s; and these case s sha ll be dee med to be
inc lude d in Schedule-1 of the Go vernment Case s Act, 2049 (1992).

33. Liai son Ministry:

The Committee sha ll make contact with Governme nt of Nepa l through the Ministry of Health.

34. Powers to frame Rules: The Governme nt of Nepa l ma y frame nece ssary Rule s in orde r to im pleme nt the objec tives of this Act.

(Source: Nepal Law Commission)

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