chhatramani/nepal_legal_acts_corpus_english huggingface dataset:
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

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

Great Seal and Date of Publication
2055.1.21

Amending Acts

1. Republic Strengthening and Some Nepal Laws Amendment Act, 2066 2066.1.7
2. Human Body Organ Transplantation (Regulation and Prohibition) (First Amendment) Act, 2072 2072.11.13
3. Some Nepal Laws Amendment, Consolidation, Adjustment and Repeal Act, 2074 2074.6.30

Act No. 20 of the year 2055



An Act Made to Provide for Matters Relating to the Transplantation of Human Body Organs

Preamble: Whereas, it is desirable to regulate the activities relating to removing organs from the human body and transplanting an organ removed from one human body into another human body for the purpose of systematic treatment of diseases according to the modern medical system, and to make provision prohibiting activities relating to the purchase, sale or use of human body organs for other purposes;

Therefore, this Act is enacted by Parliament in the twenty-eighth year of the reign of His Majesty King Birendra Bir Bikram Shah Dev. Chapter-1

Short Title and Commencement

1. Short Title and Commencement: (1) This Act may be called the "Human Body Organ Transplantation (Regulation and Prohibition) Act, 2055".

(2) This Act shall come into force on such date as the Government of Nepal may, by notification in the Nepal Gazette, appoint. 2. Definitions: Unless the subject or context otherwise requires, in this Act,-

(a) "Human body" means the body of a living or deceased human being. Added by the First Amendment.(a1) "Brain death" means the death of the brain stem, and the said term also denotes a condition where there is irreversible damage to the receptive and responsive activity of the brain. Explanation: "Brain stem" means the midbrain, pons, and medulla oblongata connecting the cerebrum and the spinal cord. Added by the First Amendment.(a2) "Irreversible damage" means a condition where the activity of the brain is completely damaged such that it cannot function again.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

Explanation: "Brain stem" means the midbrain, pons, and medulla oblongata connecting the cerebrum and the spinal cord. Added by the First Amendment.(a2) "Irreversible damage" means a condition where the activity of the brain is completely damaged such that it cannot function again. Added by the First Amendment.(a3) "Ministry" means the Ministry of Health.

(b) "Organ" means any organ of the human body, and the said term also denotes the tissues of the human body.

(c) "Organ transplantation" means the act of transplanting an organ of one human body into another human body for the purpose of systematic treatment of diseases according to the modern medical system.

(d) "Activity relating to organ transplantation" means the activities of removing an organ from a human body, storing the organ so removed in a safe manner adopting scientific techniques and methods, or transplanting it into another human body, for the purpose of systematic treatment of diseases according to the modern medical system.

(e) "Health institution" means a health institution which has obtained a license to conduct activities relating to organ transplantation pursuant to this Act.

(f) "License" means the license granted pursuant to Section 5 to conduct activities relating to organ transplantation.

(g) "Personal permit" means the personal permit granted pursuant to Sub-section (1) of Section 8 to conduct activities relating to organ transplantation.

(h) "Medical practitioner" means a medical practitioner qualified pursuant to Sub-section (2) of Section 8, and the said term also denotes the team of medical practitioners pursuant to Section 12ch.

(i) "Committee" means the Organ Transplantation Coordination Committee constituted pursuant to Section 12. Amended by the First Amendment.(j) "Donor" means a person who donates an organ, and the said term also denotes, in the case of a deceased person, a member of the family of such deceased person who donates the organ of the deceased. Explanation: "Member of the family" means, in order of priority, husband, wife, son, daughter, father, mother, adopted son, adopted daughter, elder brother, younger brother, elder sister, younger sister, grandfather, grandmother, grandson, granddaughter, mother-in-law, father-in-law.

(k) "Recipient" means a person who receives an organ donated by a donor pursuant to this Act.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

Added by the First Amendment.(l) "Near relative" means the husband, wife, son, daughter, adopted son, adopted daughter, father, mother, parents adopting an adopted son or adopted daughter, step-father, step-mother, grandfather, grandmother, grandson, granddaughter, elder brother, younger brother, elder sister, younger sister, uncle (elder brother of father), aunt (elder brother's wife), uncle (father's younger brother), aunt (father's younger brother's wife), nephew (brother's son), niece (brother's daughter), mother-in-law, father-in-law, elder brother-in-law (husband's elder brother), wife of elder brother-in-law, younger brother's wife (husband's younger brother's wife), husband's younger sister, husband's younger brother, elder brother's wife (wife of elder brother), daughter-in-law, maternal uncle, maternal uncle's wife, nephew (sister's son), niece (sister's daughter), wife's brother, wife's sister, aunt (father's sister), uncle (father's sister's husband), elder sister, elder sister's husband, husband's elder sister, husband of husband's elder sister, younger sister's husband, son-in-law, husband of wife's elder sister. Provided that, in the case of an adopted son, adopted daughter, parents adopting an adopted son or adopted daughter, and a relationship established through marital relations, the relationship must have existed continuously for at least two years.

(m) "As prescribed" means as prescribed in the rules framed under this Act. Chapter-2

License and Personal Permit Relating to Organ Transplantation

3. Not to conduct activities relating to organ transplantation without obtaining a License: No person shall conduct or cause to be conducted any activity relating to organ transplantation without obtaining a license pursuant to this Act. 4. To submit application for License: Except for a government hospital designated by the Government of Nepal by notification in the Nepal Gazette, any other person desiring to conduct activities relating to organ transplantation shall submit an application to the Committee in the form as prescribed, together with the prescribed fee. 5. To grant License: (1) Upon receipt of an application pursuant to Section 4, the Committee shall, after completing the prescribed procedure, grant a license to the applicant in the form as prescribed.

(2) The physical facilities, manpower, and other necessary amenities to be arranged by the concerned applicant in order to obtain a license pursuant to Sub-section (1) shall be as prescribed. 6. Not to conduct activities relating to organ transplantation without obtaining a Personal Permit: No person shall conduct any activity relating to organ transplantation without obtaining a personal permit pursuant to this Act. 7. To submit application for Personal Permit: A medical practitioner desiring to conduct activities relating to organ transplantation shall submit an application to the Committee in the form as prescribed, together with the prescribed fee, for a personal permit. 8.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

7. To submit application for Personal Permit: A medical practitioner desiring to conduct activities relating to organ transplantation shall submit an application to the Committee in the form as prescribed, together with the prescribed fee, for a personal permit. 8. To grant Personal Permit: (1) Upon receipt of an application pursuant to Section 7, the Committee shall, after completing the prescribed procedure, grant a personal permit to the applicant in the form as prescribed.

(2) The qualifications to be acquired by a medical practitioner to obtain a personal permit pursuant to Sub-section (1) shall be as prescribed. 9. Term and Renewal of License: (1) The term of a license shall remain valid for two years from the date of granting the license, unless it is cancelled earlier pursuant to Section 10.

(2) Before the expiry of the term of the license, the concerned health institution shall submit an application to the Committee for renewal of the license in the form as prescribed, together with the prescribed fee.

(3) Upon receipt of an application pursuant to Sub-section (2), the Committee shall, after completing the prescribed procedure, renew the term of the license for a period of two years each time.

(4) A license not renewed pursuant to Sub-section (3) shall be automatically cancelled. 10. Cancellation and Suspension of License and Personal Permit: (1) If a health institution or a medical practitioner holding a personal permit acts contrary to this Act or the rules framed under this Act, or fails to comply with the orders and directions given by the Committee pursuant to Section 29, the Committee may suspend (for a period of up to six months) or cancel the license of such health institution or the personal permit of such medical practitioner.

(2) Before suspending or canceling a license or personal permit pursuant to Sub-section (1), the Committee shall give the concerned health institution or medical practitioner a reasonable opportunity to present their defense. 11. Appeal: (1) A health institution or medical practitioner aggrieved by an order given by the Committee pursuant to Sub-section (1) of Section 10 may, within thirty-five days from the date of such order, appeal to the Government of Nepal, Ministry of Health.

(2) The decision of the Government of Nepal, Ministry of Health, regarding an appeal filed pursuant to Sub-section (1) shall be final. Chapter-3

Organ Transplantation Coordination Committee

12.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

Chapter-3

Organ Transplantation Coordination Committee

12. Organ Transplantation Coordination Committee: (1) In addition to the other functions, duties, and powers written in this Act, an Organ Transplantation Coordination Committee consisting of the following Chairperson and Members shall be constituted for preparing policies, plans, and programs relating to organ transplantation and submitting them to the Government of Nepal:-

(a) Senior medical practitioner nominated by the Government of Nepal — Chairperson
(b) Three medical practitioners nominated by the Government of Nepal — Member
Amended by the First Amendment.(c) Representative, Ministry, of the rank of Gazetted First Class or equivalent — Member
Amended by the First Amendment.(d) Representative, Ministry of Law, Justice and Parliamentary Affairs — Member
(e) Representative, Nepal Medical Council — Member
(f) Representative, Nepal Medical Association — Member
(g) Director General, Department of Health Services — Member-Secretary

(2) The term of office of the Chairperson and Members nominated pursuant to clauses (a) and (b) of Sub-section (1) shall be two years, and they may be re-nominated after the expiry of their term.

(3) Omitted by the First Amendment

(4) The Committee may, if it deems necessary, invite any expert or advisor to participate in the meetings of the Committee as an observer.

(5) The procedure of the meetings of the Committee shall be as determined by the Committee itself.

(6) The necessary budget for the Committee shall be provided by the Government of Nepal.

(7) The meeting allowance and other facilities of the Chairperson and Members of the Committee shall be as prescribed.

(8) The Secretariat of the Committee shall be located at the Department of Health Services of the Government of Nepal. Chapter-3A

Relating to Brain Death

12A. Health examination to be conducted: Before a medical practitioner examines any patient for the purpose of Section 12B, he/she shall conduct a preliminary health examination of such patient as prescribed. 12B.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

Chapter-3A

Relating to Brain Death

12A. Health examination to be conducted: Before a medical practitioner examines any patient for the purpose of Section 12B, he/she shall conduct a preliminary health examination of such patient as prescribed. 12B. May examine to ascertain whether there is complete brain damage: (1) A medical practitioner may conduct a health examination to ascertain whether there is complete brain damage in a patient only if the following conditions exist in such patient:-

(a) There is irreversible damage,
(b) There is no response in the brain stem,
(c) There is no natural respiration in the patient's body.

(2) To conduct a health examination pursuant to Sub-section (1), the medical practitioner shall obtain written consent from any member of the patient's family.

(3) Notwithstanding anything contained in Sub-section (2), if no member of the family of a patient who needs to be examined pursuant to Sub-section (1) is available, or in the case of an Added by the First Amendment.unclaimed patient, the medical practitioner shall conduct the health examination of the patient in the presence of the head of the concerned health institution and an officer-level representative of the District Administration Office.

(4) If the health examination pursuant to Sub-section (1) is to be conducted by the head of the concerned health institution, the other senior medical practitioner of that health institution shall be present during the examination as per Sub-section (3).

(5) If the health examination conducted by the medical practitioner pursuant to Sub-section (1) reveals that there is irreversible damage to the patient's brain, no response in the brain stem, and no natural respiration in the patient's body, the patient shall be re-examined six hours after such health examination to confirm brain death. 12C. Health examination not to be conducted: Notwithstanding anything contained in Section 12B, a medical practitioner shall not conduct a health examination of a patient to ascertain whether there is complete brain damage in any of the following conditions:-

(a) The disease is undiagnosed,
(b) The patient's body temperature is below a minimum of thirty-five degrees Celsius,
(c) The patient's minimum blood pressure (systolic less than ninety millimeters of mercury) is present,
(d) There is an imbalance in the patient's internal glands,
(e) The patient is unconscious due to the use of intoxicating drugs. Explanation: For the purpose of this clause, "intoxicating drugs" means narcotic drugs, sleeping pills, anesthetic drugs, or muscle relaxant drugs. 12D.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

Explanation: For the purpose of this clause, "intoxicating drugs" means narcotic drugs, sleeping pills, anesthetic drugs, or muscle relaxant drugs. 12D. To declare brain death: (1) If the health examination conducted pursuant to Sub-section (5) of Section 12B also shows that the patient's brain is dead, the medical practitioner shall declare that the patient is brain dead.

(2) After a declaration of brain death is made pursuant to Sub-section (1), such patient shall be deemed to have died.

(3) Other provisions relating to the declaration of brain death shall be as prescribed. 12E. To inform about brain death: (1) Before declaring brain death pursuant to Section 12D, the medical practitioner shall inform the members of the patient's family that the patient is brain dead, along with the factual details of the patient's health examination.

(2) Notwithstanding anything contained in Sub-section (1), in the case of a patient whose family member is not available, or an unclaimed patient, the medical practitioner shall declare the patient's brain death pursuant to Section 12D and inform the concerned District Administration Office and the Ministry thereof. 12F. Qualification of medical practitioner: Only a medical practitioner possessing the following qualifications may be involved in declaring brain death:-

(a) Has obtained at least a post-graduate degree in medical science and has worked in a field related to that subject for at least five years,
(b) Is permanently registered with the Nepal Medical Council as a specialist medical practitioner,
(c) Is a Nepali citizen. 12G. Health examination to be conducted by a team of medical practitioners: When conducting a health examination of a patient and declaring the brain death of the patient pursuant to this Chapter, it shall be done by a team of medical practitioners consisting of at least one anesthesiologist or intensivist including a specialist medical practitioner related to the patient's disease who is involved in the treatment of the patient, among the medical practitioners qualified pursuant to Section 12F. 12H. Infrastructure required in a health institution: A health examination of a patient pursuant to Sections 12A and 12B may only be conducted at a health institution that has infrastructure as prescribed. 12I. Not to be involved in declaring brain death or in the act of organ transplantation: A surgeon who performs organ transplantation pursuant to this Act shall not be involved in declaring brain death, and a medical practitioner who declares brain death shall not be involved in the act of organ transplantation. Chapter-4

Activities Relating to Organ Transplantation

13. Not to conduct activities relating to organ transplantation: Activities relating to organ transplantation shall not be conducted for the purpose of buying or selling organs or for other similar purposes. 14.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

Chapter-4

Activities Relating to Organ Transplantation

13. Not to conduct activities relating to organ transplantation: Activities relating to organ transplantation shall not be conducted for the purpose of buying or selling organs or for other similar purposes. 14. May remove organ and transplant organ: Subject to the other provisions contained in this Act, an organ may be removed from a human body, and an organ may be removed from one human body and transplanted into another human body, only for the purpose of systematic treatment of diseases according to the modern medical system. Added by the First Amendment.14A. May donate an organ: (1) The following persons may donate their organ to a patient:-

(a) A near relative of the patient,
(b) In a situation where an organ needs to be transplanted to any member of two or more families, if the organ of a near relative of such families does not match and transplantation cannot be performed, and if the organ sought to be transplanted matches with a member of another family, a member of each other's family on the basis of mutual consent in writing.

(2) In the case under clause (b) of Sub-section (1), a person desiring to donate an organ or receive an organ shall submit an application to the Committee as prescribed, in the form as prescribed, stating the details thereof, for approval.

(3) If, upon inquiry into the details of the application received pursuant to Sub-section (2), it appears reasonable, the Committee may grant approval to the concerned persons to donate or receive the organ.

(4) The act of organ transplantation pursuant to clause (b) of Sub-section (1) shall be performed simultaneously by conducting parallel surgery at the same time. 15.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

15. May remove an organ from the body of a living person: (1) Subject to the other provisions contained in this Act, an organ may be removed from the body of a living person (donor) and transplanted into the body of the Amended by the First Amendment.concerned patient only in the following circumstances:-

(a) At least two concerned medical practitioners have certified that an organ in the body of a patient has been destroyed so as to be non-functional, and it is necessary to transplant another organ in place of the destroyed organ in the patient's body to save the patient's life,
Amended by the First Amendment.(b) The donor has given written consent to voluntarily donate an organ to the patient as per clause (a), with the consent of his/her near relative,
(c) The donor consenting to voluntarily donate an organ pursuant to clause (b) has completed eighteen years of age,
(d) At least two concerned medical practitioners have certified that if any one of the paired organs of the body of the donor consenting pursuant to clause (b) is removed, the donor will not immediately die due to that cause and will not become permanently disabled or handicapped,
(e) At least two concerned medical practitioners have certified that the tissue sought to be removed from the donor's body can regenerate.

(2) Subject to the other provisions contained in this Act, if at least two concerned medical practitioners certify that a tissue can regenerate in the body of a person who has not completed eighteen years of age, this Section shall not be deemed to prevent the removal of such tissue from the body of such person.

(3) This Section shall not be deemed to prevent the removal and disposal of a non-functional organ from a person's body during the course of his/her treatment.

(4) The procedure relating to giving consent and approval pursuant to clause (b) of Sub-section (1) shall be as prescribed.

(5) A donor may, if he/she so desires, withdraw the consent given pursuant to clause (b) of Sub-section (1).

(6) If the donor withdraws the consent pursuant to Sub-section (5), the recipient shall not be entitled to claim any kind of compensation from the donor. 16.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

16. May remove an organ from the body of a deceased person: (1) Subject to the other provisions contained in this Act, an organ may be removed from the body of a deceased person, or an organ so removed may be transplanted into the body of any other person, only in the following circumstances:-

Amended by the First Amendment.(a) The concerned medical practitioner has declared that the person from whose body the organ is to be removed is brain dead,
(b) The person desiring to donate his/her organ for the purpose of Section 14 after death has given knowing and voluntary written consent,
Added by the First Amendment.(c) In the absence of consent as per clause (b), any member of the family of the deceased has given written consent to donate the organ of the deceased's body. Provided that, if the deceased, while alive, has expressed in writing his/her wish not to donate his/her body organs, a family member shall not be able to donate the organ of such deceased person's body.

(2) Other procedures relating to giving consent pursuant to clause Amended by the First Amendment.(b) and (c) of Sub-section (1) shall be as prescribed. Added by the First Amendment.16A. May remove organ before post-mortem examination: Notwithstanding anything contained in any prevailing law, if the Committee as prescribed is satisfied that the death of the deceased occurred due to an accident, an organ may be removed from the body of the deceased before conducting a post-mortem examination of the deceased with the approval of that Committee. 17. Not to transplant an organ from the body of a deceased person: Amended by the First Amendment.Notwithstanding anything contained in Section 16 or 16A, an organ shall not be removed from the body of any deceased person and transplanted into another human body in a manner that may affect the post-mortem examination of a person who died as a result of homicide, suicide, or under suspicious circumstances. Provided that, this Section shall not be deemed to prevent the removal of an organ from such deceased person for the purpose of post-mortem examination or any other investigation. Added by the First Amendment.17A. To prepare a priority list: A health institution shall, for the purpose of transplanting an organ removed from the body of a deceased person, prepare and update a list of recipients in the order of priority as prescribed. Added by the First Amendment.17B.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

Added by the First Amendment.17A. To prepare a priority list: A health institution shall, for the purpose of transplanting an organ removed from the body of a deceased person, prepare and update a list of recipients in the order of priority as prescribed. Added by the First Amendment.17B. To designate a Coordination Unit: (1) For the purpose of making arrangements to remove organs from a person declared brain dead pursuant to Section 12D, safely store the removed organs, maintain accurate records of persons who need organ transplantation, and distribute the obtained organs according to the order of priority as prescribed, the Government of Nepal shall, by notification in the Nepal Gazette, designate a Coordination Unit.

(2) Until a Coordination Unit is designated pursuant to Sub-section (1), the Human Organ Transplantation Centre, Bhaktapur, shall perform the functions of the Coordination Unit.

(3) If any hospital or health centre declares a person brain dead pursuant to Section 12D, it shall immediately inform the Coordination Unit.

(4) Upon receiving information pursuant to Sub-section (3), the Coordination Unit shall coordinate with the concerned health institution for organ transplantation.

(5) The concerned hospital or health centre declaring brain death shall provide the necessary physical facilities and manpower required for the arrangement of organ removal to the Coordination Unit.

(6) Other functions of the Coordination Unit shall be as prescribed. Added by the First Amendment.17C. May provide amount: After activities relating to organ transplantation of a person declared brain dead pursuant to Section 12D are conducted, the Government of Nepal may provide an amount as prescribed to the hospital or health centre declaring brain death, the health institution performing the organ transplantation, and the family member of the person declared brain dead. 18. To warn of possible risks: While removing an organ or transplanting an organ pursuant to this Act, the medical practitioner shall examine the health of the donor and the recipient and inform both parties of the possible effects and risks to their health arising therefrom. 19. Consent of the recipient required: (1) When transplanting an organ pursuant to this Act, the consent of the recipient shall also be required.

(2) If the recipient is a minor or in a condition unable to make a decision, a near relative of such person on his/her behalf may give such consent. 20.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

20. Organ transplantation may be conducted without consent: Notwithstanding anything contained in Section 19, an organ transplantation may be conducted even without the consent of a family member of the Amended by the First Amendment.recipient in the following circumstances:-

(a) If the recipient is unclaimed,
(b) If it is not possible to obtain consent from a near relative of the recipient after giving notice within a reasonable time,
(c) If, in the circumstances mentioned in clauses (a) and (b), there is a possibility that such person may die if organ transplantation is not performed immediately. 21. Cost and Service Fee: A health institution may, while performing organ transplantation pursuant to this Act, charge a cost and service fee from the recipient. Provided that,

(a) The rate of such service fee must be approved by the Committee.
(b) The rate of such service fee must be published as directed by the Committee.
(c) The rate of such service fee must be reasonable and fair. 22. Technical matters to be adopted while removing or transplanting an organ: The technical matters relating to modern medical science to be adopted while removing an organ, or while safely storing the removed organ, or while transplanting an organ pursuant to this Act, shall be as prescribed. Chapter-5

Offences and Penalties

23. Offence relating to organ transplantation: Amended by the First Amendment.If any person removes an organ from another person, or transplants an organ so removed into another person, or uses it for any other purpose, or is directly involved in such an act, in contravention of the provisions mentioned in Sections 12A, 12B, 12C, 12D, 12E, 12F, 12G, 12H, 12I, 13, 14, 15, 16 and 17, he/she shall be deemed to have committed an offence under this Act. 24.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

24. Penalty: (1) A person committing an offence pursuant to Section 23 shall be liable to imprisonment for up to five years and a fine of up to five hundred thousand rupees.

(2) If a person commits an offence pursuant to Section 23 in a place other than a health institution, he/she shall be liable to an additional imprisonment of up to one year and a fine of up to one hundred thousand rupees in addition to the penalty under Sub-section (1).

(3) If a person who has not obtained a personal permit commits an offence pursuant to Section 23 in a place other than a health institution, such person shall be liable to an additional imprisonment of up to two years and a fine of up to two hundred thousand rupees in addition to the penalty under Sub-section (1).

(4) In the case of an offence under Section 23, if Amended by the First Amendment.the living person from whom the organ is removed dies within three months due to that same injury, the person committing such offence shall be liable to Omitted by the First Amendment. life imprisonment.

(5) In addition to the matters written in Sub-sections (1), (2), (3) and (4), a person conducting activities relating to organ transplantation in contravention of the provisions contained in this Act or the rules framed under this Act shall be liable to imprisonment for up to one year and a fine of up to one hundred thousand rupees. 25. Penalty for attempt: If all preparations for committing an offence under Section 23 are completed but the offence is not actually committed, it shall be deemed an attempt to commit such offence, and a person attempting such offence shall be liable to half the penalty provided under Section 24. 26. Penalty for abetment: A person who, except for a person directly involved in causing an offence under Section 23, provides assistance in committing such offence shall be deemed an abettor, and the abettor shall be liable to half the penalty imposed on the accused. 27. Not to advertise or publicize: (1) No person shall, directly or indirectly, advertise or publicize through communication means regarding the availability of an organ or the need for an organ.
Human Body Organ Transplantation (Regulation and Prohibition) Act, 1998

27. Not to advertise or publicize: (1) No person shall, directly or indirectly, advertise or publicize through communication means regarding the availability of an organ or the need for an organ. Provided that, this Section shall not be deemed to prevent the dissemination of information relating to organ transplantation for the purpose of imparting technical knowledge about organ transplantation.

(2) A communication institution, publisher, and editor, as well as a broadcasting institution and broadcaster, that publishes an advertisement contrary to Sub-section (1) may be fined up to twenty-five thousand rupees by the prescribed authority.

(3) A person aggrieved by a fine imposed by the prescribed authority pursuant to Sub-section (2) may, within 35 days from the date of knowing about such fine, appeal to the Appellate Court. Chapter-6

Miscellaneous

28. Inspection: (1) An officer authorized by the Committee may inspect whether a health institution or a medical practitioner holding a personal permit is complying with this Act or the rules framed under this Act and the orders and directions given pursuant to Section 29 while conducting activities relating to organ transplantation.

(2) An officer inspecting pursuant to Sub-section (1) shall submit a report of the inspection conducted by him/her to the Committee. 29. May give orders and directions: (1) The Committee may, in the case of an inspection conducted by an authorized officer pursuant to Section 28 or in any other case, give necessary orders and directions to a health institution or a medical practitioner holding a personal permit regarding the conduct of activities relating to organ transplantation.

(2) While giving orders and directions pursuant to Sub-section (1), the Committee shall give them specifically on the following matters:-

(a) Regarding the technical aspects to be adopted during organ transplantation in accordance with the principles of medical science,
(b) Regarding the physical resources and manpower required for organ transplantation,
(c) Regarding the safe storage of organs removed from the human body for transplantation by adopting scientific techniques and methods,
(d) Regarding the minimum safety measures to be adopted during organ transplantation,
(e) Regarding the dissemination of information on technical matters relating to organ transplantation.

(3) It shall be the duty and responsibility of the concerned health institution and medical practitioner holding a personal permit to comply with or cause to comply with the orders and directions given by the Committee pursuant to Sub-section (2). 30. Not compelled to give statement: A health institution or a medical practitioner holding a personal permit, and persons related to such institution or medical practitioner, shall not be compelled to give a statement to anyone other than the officer authorized pursuant to prevailing law regarding the activities relating to organ transplantation conducted pursuant to this Act.
Special Economic Zone Act, 2016

Special Economic Zone Act, 2073

Certification and Publication Date
2073.06.18

Amending Acts

1. Special Economic Zone (First Amendment) Act, 2075 2075.12.13
2. Act to Amend Certain Nepal Acts Relating to Investment Facilitation, 2081 2081.03.24
3. Act to Amend Certain Nepal Acts Relating to Improvement of Economic and Business Environment and Enhancement of Investment, 2081 2081.12.18

Act No. 9 of the Year 2073

An Act Made to Provide for the Establishment, Operation and Management of Special Economic Zones

Preamble: Whereas, it is expedient to make legal provisions for the establishment, operation and management of Special Economic Zones to accelerate the pace of economic development by advancing the process of industrialization in the country through the promotion of exports,

The Legislature-Parliament has enacted this Act pursuant to Sub-Article (1) of Article 296 of the Constitution of Nepal. Chapter-1
Preliminary

1. Short Title and Commencement: (1) This Act may be called the "Special Economic Zone Act, 2073".

(2) It shall come into force immediately. 2. Definitions: Unless the subject or context otherwise requires, in this Act,-

(a) "Chairperson" means the Chairperson of the Committee.

(b) "License" means the license obtained pursuant to Section 8.

(c) "Licensee" means an investor who has obtained a license pursuant to Section 8. Amended by the Act to Amend Certain Nepal Acts Relating to Improvement of Economic and Business Environment and Enhancement of Investment, 2081.(d) "Industry" means an industry other than an industry included in the list of industries that cannot be established in a Special Economic Zone pursuant to Section 5.

(e) "Prescribed" or "as prescribed" means prescribed or as prescribed in the Rules framed under this Act.

(f) "Infrastructure Structure" means the structure required for the development of a Special Economic Zone, and that term also includes a pharmacy, hospital, post office, banking service, child care center, school and canteen to be established in the Special Economic Zone.

(g) "Authority" means the Special Economic Zone Authority established pursuant to Section 14.

(h) "Investor" means a person, firm, company or organized body investing in the construction of an industry or infrastructure structure, and that term also includes a foreign government, foreign person or international organization investing in the construction of an industry or infrastructure structure.

(i) "Ministry" means the Ministry of Industry.

(j) "Special Economic Zone" means a Special Economic Zone designated pursuant to Section 3.

(k) "Member" means a member of the Committee, and that term also includes the Chairperson.

(l) "Committee" means the Management Committee formed pursuant to Section 19. Chapter-2
Provisions Relating to Establishment, Operation and Management of Special Economic Zone

3.
Special Economic Zone Act, 2016

Chapter-2
Provisions Relating to Establishment, Operation and Management of Special Economic Zone

3. Power to Designate Special Economic Zone: (1) The Government of Nepal may, on the recommendation of the Authority, by publishing a notice in the Nepal Gazette, designate any place in Nepal as a Special Economic Zone.

(2) The Special Economic Zone designated pursuant to Sub-section (1) may include an Export Processing Zone, an Export Promotion House or any other zone designated by the Government of Nepal. Explanation: For the purposes of this Section,-

(a) "Export Processing Zone" means the area within a Special Economic Zone developed for establishing export-oriented industries.

(b) "Export Promotion House" means a company, firm or cooperative institution established pursuant to the prevailing law for the purpose of collecting products of industries established within the Special Economic Zone and exporting them abroad. 4. Proposal for Establishment of Special Economic Zone: (1) If the Authority finds it appropriate to designate any place as a Special Economic Zone pursuant to Section 3, it shall conduct a necessary survey thereof and submit a proposal to the Government of Nepal for designating that place as a Special Economic Zone along with a detailed report thereof. Explanation: For the purposes of this Section, "survey" means a survey conducted to ascertain a suitable place for establishing a Special Economic Zone, and that term also includes a feasibility study and engineering design of the Special Economic Zone.

(2) While conducting a survey pursuant to Sub-section (1), the Authority shall, in addition to other matters, also take into account matters such as road access, telecommunication service, electricity and water facilities, sufficiency of land, availability of workers and raw materials. Inserted by the First Amendment.(3) Based on the proposal submitted pursuant to Sub-section (1), the Government of Nepal may designate such place as a Special Economic Zone. 5. Preparation of List of Industries: (1) The Authority shall prepare and publish a list of industries as prescribed that cannot be established in a Special Economic Zone. Amended by the First Amendment.

(2)

(3) Deleted by the First Amendment

Amended by the First Amendment.6.
Special Economic Zone Act, 2016

5. Preparation of List of Industries: (1) The Authority shall prepare and publish a list of industries as prescribed that cannot be established in a Special Economic Zone. Amended by the First Amendment.

(2)

(3) Deleted by the First Amendment

Amended by the First Amendment.6. Establishment and Operation of Special Economic Zone may be Done by the Private Sector: (1) The Government of Nepal may, on the recommendation of the Authority, approve the private sector to establish a Special Economic Zone and to operate, manage and develop the infrastructure structure of such Special Economic Zone.

(2) The Government of Nepal may, with the joint participation of the Government of Nepal and the private sector, or by the private sector, operate and manage the Special Economic Zone designated pursuant to Sub-section (3) of Section 4 or develop the infrastructure structure thereof.

(3) Other provisions relating to the establishment, operation and management of a Special Economic Zone or development of infrastructure structure pursuant to Sub-section (1) or (2) shall be as prescribed. 7. Industry may be Transferred and Operated in Special Economic Zone: An investor of an industry registered or licensed under the prevailing law and operating outside a Special Economic Zone at the time of commencement of this Section may transfer the machinery, tools or equipment already put into use to the Special Economic Zone and operate the industry. Chapter-3
Provisions Relating to License

8.
Special Economic Zone Act, 2016

Chapter-3
Provisions Relating to License

8. License Required: (1) An investor desiring to establish any industry by making investment of capital as prescribed in a Special Economic Zone shall submit an application to the Authority in the prescribed format stating the prescribed particulars.

(2) Upon inquiry into the application filed pursuant to Sub-section (1), if it appears appropriate to grant the license, the Authority shall, by collecting the fee as prescribed, issue the license to the applicant in the prescribed format within thirty days from the date of receipt of the application.

(3) Deleted by the First Amendment

(4) Deleted by the First Amendment

(5) If applications are filed pursuant to Sub-section (1) to establish more than one industry of the same type in a Special Economic Zone and it is not possible to grant licenses to establish all such industries as demanded in that Zone, the Authority may, on the basis of the priority prescribed, grant a license to any investor in the prescribed format.

(6) If, Amended by the Act to Amend Certain Nepal Acts Relating to Investment Facilitation, 2081.upon inquiry into the application pursuant to Sub-section (2) , it is not possible to grant the license, the Authority shall give information thereof along with the reason to the applicant within seven days from the date of such decision.

(7) A person or body aggrieved by the decision made by the Authority pursuant to Sub-section (6) may appeal to the Ministry within thirty-five days from the date of receipt of the information of the decision.

(8) If an appeal is filed pursuant to Sub-section (7), the Ministry shall decide within thirty days from the date of filing of such appeal.

(9) The decision made by the Ministry pursuant to Sub-section (8) shall be final. 9.
Special Economic Zone Act, 2016

10. Power to Cancel License: (1) If the Licensee fails to get the license renewed within the period pursuant to Sub-sections (2) and (3) of Section 9, such license shall stand cancelled.

(2) If the Licensee commits or causes to be committed any of the following acts, the Authority may cancel the license obtained by him/her/it:-

(a) Amended by the Act to Amend Certain Nepal Acts Relating to Improvement of Economic and Business Environment and Enhancement of Investment, 2081.Failure to enter into an agreement within the period referred to in Section 11, or failure to establish and operate the industry within the period stipulated in the agreement,

(b) Failure to fulfill the obligation pursuant to Section 12,

Deleted by the Act to Amend Certain Nepal Acts Relating to Improvement of Economic and Business Environment and Enhancement of Investment, 2081.(c) ,

(d) Misuse of the concessions obtained by the industry,

(e) If it is proved that the concessions were obtained by providing false details.

(3) Before canceling the license pursuant to Sub-section (2), the Authority shall give the concerned Licensee a reasonable opportunity to submit his/her/its defense.

(4) If the license is canceled pursuant to Sub-section (1) or (2), the agreement entered into with the Licensee shall be deemed to have been automatically terminated.

(5) If the license is canceled pursuant to Sub-section (1) or (2), the Licensee shall not be entitled to claim any kind of compensation in lieu of the investment made in the industry, and shall not be entitled to obtain any concession and facility under this Act from the date of cancellation of the license.

(6) If the license is canceled pursuant to Sub-section (1) or (2), the Licensee shall dispose of his/her/its immovable property situated in the Special Economic Zone within one year from the date of such cancellation of the license.

(7) If the Licensee is unable to dispose of his/her/its immovable property within the period pursuant to Sub-section (6), such property shall vest in the Government of Nepal.

(8) Before canceling the license pursuant to Sub-section (2), the Authority may itself or through any authorized officer under it understand necessary matters or cause an inquiry to be made.

(9) A Licensee aggrieved by the cancellation of license pursuant to Sub-section (2) may appeal to the concerned High Court within thirty-five days. Amended by the Act to Amend Certain Nepal Acts Relating to Improvement of Economic and Business Environment and Enhancement of Investment, 2081.11.
Special Economic Zone Act, 2016

Amended by the Act to Amend Certain Nepal Acts Relating to Improvement of Economic and Business Environment and Enhancement of Investment, 2081.11. Agreement Required: (1) The Licensee shall, within one hundred twenty days from the date of obtaining the license, enter into an agreement with the Authority on the following matters relating to the establishment and operation of the industry:-

(a) The lease or rental amount or fee to be paid by the Licensee for the use of buildings, land or services (electricity, water, drainage, waste management, etc.) required for the industry,

(b) The date for establishing and operating the industry,

(c) The quantity of production to be exported by the industry,

(d) In case of a foreign investor, the matter of technology transfer,

(e) Other matters as prescribed.

(2) If the Licensee files an application to extend the period stating a reasonable cause for being unable to enter into the agreement within the period pursuant to Sub-section (1), the Authority may extend the period for up to thirty days once. Chapter-4
Duties and Obligations of Licensee

12. Obligation of Licensee: It shall be the obligation of the Licensee to comply with the agreement made with the Authority pursuant to Section 11 and this Act or the Rules framed under this Act. Amended by the First Amendment.13. Export Required: Amended by the Act to Amend Certain Nepal Acts Relating to Investment Facilitation, 2081.(1) The Licensee shall export at least fifteen percent of the production within four years from the date of commencement of production by the industry established in the Special Economic Zone, and at least thirty percent of the production in subsequent years of goods or services. Inserted by the Act to Amend Certain Nepal Acts Relating to Improvement of Economic and Business Environment and Enhancement of Investment, 2081.Provided that, if unable to export due to circumstances beyond control, the industry may, with prior approval of the Authority, sell the quantity so permitted within the domestic market of Nepal for the duration of such circumstances.