Kidney Transplantation (Regulation and Prohibition) Rules, 2058 (2002)

Kidney Transplantation (Regulation and Prohibition) Rules, 2058 (2002)

Kidney Transplantation (Regulation and Prohibition)
Rules, 2058 (2002)
Date of publication in Nepal Gazette
2058.10.22 (4 Feb. 2002)
In exercise of the powers conferred by Section 34 of the Human Body Organ Transpla nta tion (Re gulation and Prohibition) Ac t, 2055(1998), the Government of Nepal has framed the following Rules.

1. Short title and commencement:

(1) These Rules may be called as  the “Kidney Transplantation (Regulation and Prohibition) Rules, 2058
(2002).”
(2) These Rules shall come into force on the date on which the Human Body Organ Transplantation (Re gulation and
Prohibition) Act, 2055 (1998) comes into force. 1

2. Definitions: Unless the subject or the context otherwise requires, in these Rules:
(a) “Act” means the H uman Body Orga n Transpla ntation (Re gulation and Prohibit ion) Ac t, 2055(1998).
(b) “Kidney” means the kidney of a human body.

3. Permit:

(1) A health institution which intends to provide the kidney transplantation service pursuant to Section 4 of the Act shall submit  an application, accompanied by the fees as referred to in Schedule-1, to the committee in a format as referred to in Schedule-2, for the permit to carry out activities pertaining thereto.  These Rules commence from 2058.10.22 (4 Feb. 2002) as per the Notification of Nepal Gazette of same date.
(2) Upon receiving an application pursuant to Sub-rule (1), the committee shall make necessary inquiry as to whether there is arrangement of physical means (facilities), human resources and other necessary facilities as referred to in Schedule-3 in the applicant health institution and whether such human resource has obtained the
qualification as referred to in Schedules 4 and 5 or not; and where such arrangement is found on such inquiry, the committee shall issue a permit to operate the kidney transplantation service to such health institution in a format as referred to in Schedule-6.

4. Application for private license:

(1) A doctor (medical practitioner) who intends to provide the kidney transplantation service, for purposes of Section 7 of the Act, shall submit an application, accompanied by the fees as referred to in Schedule-1 and a certified
copy of the certificate of qualification as referred to in Schedule – 4, to the committee in a format as referred to in Schedule-7, for the private license.
(2) Upon receiving an application pursuant to Sub-rule (1), the committee shall, if such doctor appears to have obtained the qualification as referred to in Schedule-4 upon holding necessary inquiry, issue the private license to provide the kidney transplantation service to such doctor in the format as referred to in Schedule-8, for
purposes of Section 8 of the Act.

5. Renewal of permit and fees: (1) Prior to at least Thirty Five days of the expiration of the period of the permit prescribed pursuant to Sub-section (1) of Section 9 of the Act, the institution ha ving obtained permit shall submit an application, accompanied by Fifty percent amount of the fees prescribed pursuant to Sub-rule (1) of Rule 3 for
the renewal of permit, to the committee in a format as referred to in Schedule-9, for the renewal of permit.
(2) Upon receiving an application pursuant to Sub-rule (1), if the concerned health institution is found to ha ve regularly arranged the physical means, human resources and other necessary services and facilities and have observed the orders and directives given from time to time pursuant to Section 29 of the Act, the committee shall renew the permit received by such health institution to operate the kidney transplantation service and give the certificate in a format as referred to in Schedule-10.

6. Brain death: For purposes of Clause (a) of Sub-section (1) of Section 16 of the Act, brain death means the state where the receptive and responsive activity of the brain (including brain stem) of any person has so stopped that it cannot be restored and, as well as, where the eye movement, corneal reflection, swallowing and motor activity
have also stopped.
7. Format of document to be certified by concerned doctor: The format of document to be certified by the concerned doctor for purposes of the following Sections of the Act shall be as follows:
(a) As referred to in Schedule-11 for purposes of Clause (a) of Subsection (1) of Section 15,
(b) As referred to in Schedule-12 for purposes of Clause (d) of Subsection(1) of Section 15.
8. Format of deed of consent: The format of the following deed of consent shall be as follows:
(a) As referred to in Schedule-13 for purposes of Clause (b) of Subsection (1) of Section 15,
(b) As referred to in Schedule-14 for purposes of Clause (b) of Subsection (1) of Section 16,
(c) As referred to in Schedule-15, in the case of a deed of consent to be given by the close relative of a donor giving deed of consent pursuant to Clause (b) after his/her death to extract the kidney from his/her body,
(d) As referred to in Schedule-16 for purposes of Sub-section (1) of  Section 19,

9. Document to be provided: The health institution having obtained permit shall submit a copy of the documents received by it pursuant to Rules 7 and 8 in the course of operation of the kidney transplantation service to the committee each time within Seven days within the date of completion of such service.

10. Prescription of authority: The committee has been prescribed as the authority for purposes of Sub-section (2) of Section 27 of the Act. 11. Meeting allowance: The chairperson, member of the committee and  observer shall get the meeting allowance as mentioned in Schedule-17 for taking part in the meeting of the committee.

12. Powers to frame Manual: The committee may frame necessary Manuals for purpose of Section 29 of the Act.
13. Power to alter schedule: The Government of Nepal may, by a notification published in the Nepal Gazette, make necessary alteration on the Schedule of this Rules.