LAW OF THE REPUBLIC OF MOLDOVA

of March 6, 2008 No. 42-XVI

About organ transplantation, fabrics and cells of the person

For the purpose of ensuring protection of the rights of donors and receivers of bodies, fabrics and cells of the person, simplification of process of transplantation, assistance to rescuing of human life or to considerable improvement of its quality, and also for the purpose of suppression of trade in parts of human body, according to provisions of the Directive of the European Parliament and Council No. 2004/23/EU of March 31, 2004 about establishment of the quality standards and safety for donorship, obtaining, control, processing, preservation, storage and distribution of human fabrics and cages, the Directive of the European Parliament and Council No. 2010/53/EU of July 7, 2010 about the quality standards and safety of the human bodies intended for transplantation and based on article 36 of the Constitution of the Republic of Moldova

The parliament adopts this organic law.

Chapter I. General provisions

Article 1. Regulation subject

This law establishes the legal base of regulation of transplantation of all bodies, fabrics and cells of the person, including the gematopoetichesky cages withdrawn from umbilical cord, marrow and peripheral blood, reproductive fabrics and cages, embryonic and fetalny fabrics and cages (including embryonic gematopoetichesky cages), except the bodies, fabrics and cages withdrawn from animals from blood and its components.

Article 2. Basic concepts

For the purpose of this law the following concepts are determined:

body - the vital separate part of human body created from various fabrics which support its structure vaskulyarization and perform physiological functions with considerable degree of autonomy. In the specified value also its part if it has the same appointment in body of the person, as the whole body is body, and corresponds to it on structure and vaskulyarization;

fabrics - all parts (anatomic educations) of human body created from cages;

cages - the separate cages or conglomerate of cages which are not connected by any type of fabric;

withdrawal - the procedure by means of which donor organs, fabrics or cages become suitable for transplantation;

transplantation - medical activities for the purpose of recovery of function of human body by organ transplantation, fabrics and cages from the donor to the receiver. Transplantation can be made from one person to another (allogenny) or own cages, fabrics and bodies (autogenic);

the donor – person who gives one or several bodies, fabrics and/or cages for therapeutic use irrespective of, donorship during lifetime of this person or after his death is performed;

the receiver – person to whom organ transplantation, and/or fabrics, and/or cells of the person is made;

bank of fabrics and/or cages - the specialized division of hospital or organization performing activities for processing, preservation, storage and distribution of fabrics and cells of the person.

Article 3. The basic principles in the field of transplantation

The basic principles in the field of transplantation are:

a) protection of advantage and identity of the person and guarantee to everyone without exception of respect for integrity and the other rights and fundamental freedoms in connection with organ transplantation, fabrics and cages;

b) medical advantage for the receiver in case of feasibility of organ transplantation, fabrics and cages from the living donor or corpse only if there are no alternative medical methods with comparable efficiency;

c) quality assurance by observance of professional standards and obligations in case of any intervention in areas of organ transplantation, fabrics and cages;

d) traceability by means of ensuring identification subject to organ transplantation, fabrics and cages - in the course of their withdrawal, storage and distribution - from the donor to the receiver and vice versa;

e) protection of the rights and personal freedoms and prevention of trade in parts of human body;

f) fair access for patients to transplant services.

Chapter II. The organization of activities in the field of transplantation

Article 4. Transplantation agency

(1) the transplantation Agency (further - the Agency) is public organization with the status of the legal entity subordinated to the Ministry of Health realizing national policy and programs of organ transplantation, fabrics and cells of the person, providing to patients equal access to transplant services. The agency is responsible for the organization of all activities in the field of transplantation at the national level and supervision of it, including:

a) donorship, withdrawal and organ transplantation, fabrics and cages;

b) creation and maintaining waiting lists of receivers;

c) creation and maintaining Register of donors of bodies;

d) distribution of bodies, fabrics or cages;

e) exchange and transportation of bodies, fabrics and cages at the national and international levels;

f) selection of organizations and crews of transplantation;

g) ensuring implementation of the quality standards and safety of bodies, fabrics and cages;

h) ensuring traceability of all bodies, fabrics and cages;

i) transplantation monitoring;

j) training of medical personnel and informing public on transplantation problems.

(2) Regulations on the organization and functioning of the Agency, its structure and extreme number affirm the Government.

Article 5. Procedure for distribution of bodies, fabrics and cages

(1) Organa, fabrics and cages are distributed to patients according to the waiting list according to the rules for apportionment approved by the order of the Minister of Health.

(2) in case of absence in lists of the compatible receiver the Agency resolves transfer of body, fabrics, cages to other organization of transplantation recognized at national or international level with which it signed bilateral agreements.

(3) the Agency has exclusive right to resolve on the basis of bilateral international agreements exchange of bodies, fabrics and cages for transplantation and takes all feasible measures that they conformed to the quality standards and safety.

Article 6. Quality control

(1) Control of activities in the field of transplantation is established by the Agency and is supported with use of quality control system and testing of all types of donorship, withdrawal, conservation, testing, storage and distribution for the purpose of quality assurance and safety of the bodies, fabrics and cages used for transplantation. Control measures and procedure for inspection affirm the Agency.

(2) For the purpose of quality assurance and safety of the bodies, fabrics and cages which are subject to withdrawal and transplantation, the Agency has the right to organize inspection and to apply adequate control measures for:

a) activities of banks of fabrics, including the procedures and actions performed by them according to this law;

b) the documents or other records made according to this law;

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