(2023.08.22-ны өдрийн орчуулга)                                                    Unofficial translation

LAW OF MONGOLIA

January 19, 2018              Ulaanbaatar city

ON THE DONORS

/Revised edition/

CHAPTER ONE

GENERAL PROVISIONS

Article 1.Purpose of the Law

1.1.The purpose of this Law is to regulate relations in connection with the comprehensive activities on voluntarily donating blood, cells, tissues, and organs for free, transplanting, and ensuring blood safety with the purpose of protecting human health and saving their lives, as well as the rights and duties of state bodies, non-governmental organizations, business entities, officials, and citizens in regards with these activities.

Article 2.Legislation of the donor

2.1.The legislation on the Donor shall consist of the Constitution of Mongolia, the Law on the Legal Status of the Mongolian Red Cross Society, the Law on Health, the Law on Health Insurance, this Law, and other legislative acts enacted in conformity with them.

2.2.If an international treaty, to which Mongolia is a party, stipulates otherwise than this Law, the provisions of the international treaty shall prevail.

Article 3.Terms of the Law

3.1.The following terms used in this Law shall be understood in the following meanings:

3.1.1."human cells, tissues, and organs" means human organs, parts of organs, and composites of cells and tissues;

3.1.2."living donor" means a person who voluntarily donates his/her cells, tissues, organs, and parts of organs for the purpose of protecting his/her or human health and saving lives;

3.1.3."non-living donor" means a dead body, whose some cells, tissues, and organs that are functioning normally can be taken for transplantation after he/she was determined the brain has completely died, the function has been irreversibly lost, or dead;

3.1.4."brain death" means irreversible loss of all functions of the brain and spinal column;

3.1.5."blood donor" means a person who voluntarily donates blood to protect human health and save life;

3.1.6."regular blood donor" means a person who donates blood two or more times a year;

3.1.7."blood and blood products" means products prepared industrially from donor blood for therapeutic purposes;

3.1.8."blood and blood components" means whole blood, blood cells and plasma with therapeutic importance;

3.1.9."comprehensive activities to ensure blood safety" means activities on promoting, popularizing and encouraging the act of donors, recruiting blood donors, collecting, analyzing, processing, storing, transporting, using, exporting and importing blood and blood components;

3.1.10."recipient" means a person who is in need of a donor cell, tissue, or organ transplant, blood or blood product transfusion in order to protect his/her life and health;

3.1.11."match of cells and tissues" means matching of cells and tissues of the donor and the recipient in terms of genetic characteristics;

3.1.12."umbilical cord blood" means the blood in the umbilical vein of the placenta after cutting the umbilical cord of the newborn;

3.1.13."stem cells" means cells derived from umbilical cord blood, peripheral blood, and bone marrow;

3.1.14."gametes" means male and female gametes;

3.1.15."donor gametes" means male or female gametes of another person;

3.1.16."surrogate mother" means a woman who carries another's embryo and gives birth to a child;

3.1.17."removal of human cells, tissues and organs" means removal of cells, tissues, organs, and parts of organs from living or non-living donors in medical conditions;

3.1.18."transplantation" means the operation of transplanting donor cells, tissues, and organs into the recipient in a medical setting;

3.1.19."cell, tissue, and organ transplantation regulatory office" /hereinafter referred to as "regulatory office"/ means the office with functions to register, supply, transport, store, and control the cells, tissues, and organs;

3.1.20."specimen" means a part of blood, cells, tissues, or organs taken from a person for the purpose of conducting diagnosis, treatment, research, prevention, and control.

Article 4.Principles to be adhered to in donor's activity

4.1.The following principles shall be adhered to in the donor's activities:

4.1.1.to respect the law and human rights;

4.1.2.to be humane and compassionate;

4.1.3.not to discriminate;

4.1.4.to ensure safety;

4.1.5.to protect sensitive personal information;

/This sub-paragraph was amended by the law of December 17, 2021/

4.1.6.to be free from receivables, and to be voluntary.

CHAPTER TWO

MANAGEMENT, STRUCTURE AND ORGANIZATION OF DONOR ACTIVITIES

Article 5.Donor activity management system

5.1.The management system of complex operations to ensure blood safety shall consist of the state central administrative body in charge of health affairs, organizations providing health care and services, the Mongolian Red Cross Society, the management of local self-governing organizations, and the Governor.

5.2.The management system for transplanting donor cells, tissues, and organs shall consist of the management of the state central administrative body in charge of health affairs, the regulatory office, and the organization providing health care and services.

Article 6.Powers of the Government in regard with donor activities

6.1.The Government shall exercise the following powers in regard with donor activities:

6.1.1.to approve and ensure the implementation of policies on blood safety, transplantation of donor cells, tissues, and organs;

6.1.2.to conclude contracts and transactions with intergovernmental and international organizations, and implement the projects and programs;

6.1.3.to create a system for blood safety, transplantation of donor cells, tissues, and organs, and to decide on the sources of financing for related expenses;

6.1.4.to provide blood and blood products and their substitutes, accumulate the stockpiles, and conduct re-supply, and ensure readiness in times of disaster;

6.1.5.other powers provided by the legislation.

Article 7.Rights and obligations of the state central administrative body in charge of health affairs

7.1.The state central administrative body in charge of health affairs shall have the following rights and obligations in regards with donor activities:

7.1.1.to ensure the implementation of donor legislation;

7.1.2.to develop a state policy on blood safety, transplantation of donor cells, tissues, and organs;

7.1.3.to monitor the safety of blood and the transplantation of donor cells, tissues, and organs;

7.1.4.to establish a regulatory office to coordinate the operation of transplantation of cells, tissues, and organs;

7.1.5.to organize complex activities for blood safety, transplantation of the cell, tissue, and organ, develop relevant procedures, instructions, and standards, and have them approved by the competent authority;

7.1.6.to approve the model of the consent form specified in paragraph 13.2 of this Law;

7.1.7.to establish an integrated registry and information database of blood, cell, tissue, and organ donors, and approval of the working procedure of the fund by the Cabinet member in charge of health affairs;

/This sub-paragraph was added by the law as of June 17, 2022/

7.1.8.to publicize and glorify the living donor of blood, cells, tissues, and organs based on the respective owner's consent, and organize events to honor the non-living donor and his/her family based on the consent of the legal representative;

/This sub-paragraph was added by the law as of June 17, 2022/

7.1.9.other rights and obligations stipulated by law.

/The numbering of this sub-paragraph was amended by the law as of June 17, 2022/

7.2.A professional and ethical committee on the issue of transplantation of the cell, tissue, and organ shall work next to the state central administrative body in charge of health affairs. The charter and composition of the respective committee shall be approved by the Cabinet member in charge of health affairs.

/This paragraph was added by the law as of June 17, 2022/

Article 8.Rights and obligations of local self-governing bodies and Governors

8.1.Local self-governing organizations and Governors shall have the following rights and obligations in regards with donor activities:

8.1.1.to promote blood donation activities, expand the lines, and support activities to improve donor retention;

8.1.2.to decide on the additional financing required for blood and blood products stockpiling and replacement in healthcare facilities within the territory under a disaster period, and provide with management and organization.

Article 9.Rights and obligations of the regulatory office

9.1.The Regulatory Office shall have the following rights and obligations in regards with transplantation of donor cells, tissues, and organs:

9.1.1.to coordinate and regulate the activities of cell, tissue, and organ of the donors, to provide professional and methodological assistance, and to supervise;

9.1.2.to coordinate and regulate the activities on determining brain death, establishing an integrated registration and information database, and conducting surveillance;

9.1.3.to perform the activities on registering, selecting, supplying, storing, transporting, and monitoring the donor cells, tissues, and organs in accordance with the instructions and procedures approved by the state central administrative body in charge of health affairs;

9.1.4.to register the recipient on the waiting list and monitor thereto;

9.1.5.to operate an integrated information database on the operation of transplanting cells, tissues, and organs;

9.1.6.to compile information and reports on donor cell, tissue, and organ transplantation at the national level and submit them to relevant organizations;

9.1.7.to resolve petitions and complaints submitted by citizens and legal entities in regards with transplantation of donor cells, tissues, and organs, and to transfer information about violations of the law to relevant law enforcement agencies;

9.1.8.to protect sensitive information of organizations and persons related to transplantation of donor cells, tissues, and organs.

/This sub-paragraph was amended by the law as of December 17, 2021/

Article 10.Rights and obligations of health care institutions

10.1.The health care institution shall have the following rights and obligations:

10.1.1.to conduct examinations and tests to prevent possible complications and adverse effects might be occurred on the health of donors who have donated blood, cells, tissues, and organs;

10.1.2.the organizations specified in sub-paragraphs 15.1.4, 15.1.5, 15.1.7, 15.1.11, 15.1.12, and 15.1.13 of the Law on Health to be employed a professional team to determine brain death;

10.1.3.to notify the regulatory office of the person who meets the conditions, requirements, and specifications for the recipient to be registered on the waiting list;

10.1.4.to notify the regulatory office within 6 hours after receiving the information specified in paragraph 13.2 of this Law;

10.1.5.to cooperate with the regulatory office on ensuring the readiness of the continued intensive treatment and transportation of non-living donors in the event that it is not possible to perform the procedure of collecting donor cells, tissues, and organs in the relevant health care institution;

10.1.6.after the removal of cells, tissues, and organs from a non-living donor, the health care organization that keeps the corpse to be responsible for arranging the external appearance of the body.

10.2.The health care organization for transplantation of donor cells, tissues, and organs shall have the following rights and obligations:

10.2.1.to carry out transplantation of cells, tissues and organs from living or non-living donors in accordance with standards;

10.2.2.to report the information related to the recipient and the donor to the regulatory office from time to time.

10.3.The health care institutions shall ensure readiness for cell, tissue, and organ transplantation, create conditions to prepare and train necessary medical specialists.

Article 11.Financing system

11.1.Financing for the activities on promoting, recruiting, collecting blood, analyzing, producing, storing, and transporting blood and blood products shall be constituted from the state and local budgets, donations of the business entities, organizations, communities, and citizens, and other sources not prohibited by law.

11.2.Financing for the acquisition and transplantation of donor cells, tissues, and organs for medical purposes shall be constituted from the state budget, health insurance, payments to be paid by the recipient, donations of the special government funds, business entities, organizations, communities, and citizens, and other sources not prohibited by law.

11.3.The price standards for donor blood, blood products, donor cell, tissue, and organ transplantation care and services shall be jointly approved by the Cabinet members in charge of health and financial and budgetary affairs.

CHAPTER THREE

REQUIREMENTS FOR DONORS, RECIPIENTS, HEALTH CARE INSTITUTIONS AND THEIR PERSONNEL

Article 12.Requirements on donor

12.1.When a donor donates blood, cells, tissues, and organs for the purpose of protecting human health and saving lives, it shall be voluntary, not for profit, and without receivables.

12.2.It shall be prohibited to discriminate against donors based on their origin, ethnicity, language, race, gender, social origin, status, wealth, occupation, position, religion, opinion, or education.

12.3.It shall be prohibited to use the donor's activities as a source of profit, to force them, or to sell them.

12.4.The following general requirements shall apply to blood donors:

12.4.1.the blood donor shall accurately report his/her health status;

12.4.2.to get acquainted with the donor selection criteria approved by the state central administrative body in charge of health affairs, and give consent in written form.

Article 13.Rights and obligations of the donor

13.1.The donor shall have the following rights and obligations:

13.1.1.to be provided with the right to be safe his/her health and life while donating blood, cells, tissues, and organs;

13.1.2.to receive a salary equal to the average salary specified in paragraph 117.2 of the Law on Labor while performing the duties of a donor;

/This sub-paragraph was amended by the law as of July 2, 2021/

13.1.3.if it is determined that the damage caused to the donor's health or the complications occurred due to the violation of the technological instructions of the blood transfusion, cell, or organ transfer procedure, compensation shall be paid by the guilty person or organization that transfused the donor's blood, transplanted the cells, tissue, or organ;

13.1.4.when donating blood, cells, tissues, and organs, the donor must sign a contract with the organization that performs the operation, obtain mandatory insurance and other insurance;

13.1.5.in case of incapacity for work after donating an organ by a living donor, to determine incapacity for work in accordance with paragraph 43.5 of the General Law on Social Insurance;

/In this sub-paragraph, the term "paragraph 28.2 of the Law on Social Insurance" was amended into the term "paragraph 43.5 of the General Law on Social Insurance" by the law as of July 7, 2023, and it shall enter into force on January 1, 2024/

13.1.6.to participate in promoting and expanding the number of blood donors.

13.2.Citizens of Mongolia who are 21 years of age can confirm their decision to accept an organ transplant to his/her subordinate or any health care and service provider organization by signature, and record it on the health insurance certificate and electronic card.

/This paragraph was amended by the law as of June 17, 2022/

13.3.The procedure for making notes specified in paragraph 13.2 of this Law shall be approved by the Cabinet member in charge of health affairs.

13.4.Citizens may change his/her decision on accepting his/her organ transplantation.

Article 14.Receive cells, tissues, and organs from living donors

14.1.Cells, tissues, and organs shall be taken from donors who meet the requirements specified in paragraph 12.1 of this Law, are mentally healthy, are 21 years of age, and have given written consent to donate their cells, tissues, and organs without endangering their lives.

/This paragraph was amended by the law as of June 17, 2022/

14.2.When taking bone grade, bone marrow, or umbilical cord blood from a child, if the child is under 14 years old, the prior written consent shall be obtained from the parent or guardian, if the child is above 14 years old, it shall be obtained from the parent, custodian, or guardian.

Article 15.Taking cells, tissues and organs from non-living donors

15.1.Cells, tissues and organs will be taken from donors who have been diagnosed with brain death.

15.2.When taking cells, tissues, or organs from non-living donor, except as specified in paragraph 13.2 of this Law, the written consent of the deceased's will, his or her biological parents, spouse, or an adult member of the cohabiting family shall be obtained.

15.3.When taking cells, tissues, and organs from a non-living donor, the heart activity shall be controlled artificially.

15.4.A doctor participating in the transplantation of donor cells, tissues, or organs or treating the recipient shall be prohibited from joining the team specified in sub-paragraph 10.1.2 of this Law.

Article 16.Requirements on the recipient

16.1.The transfusion of the donor blood and blood product, and transplantation of the cell, tissue, and organ can be performed for the purpose of improving health and saving lives of citizens regardless of race, ethnicity, language, race, gender, social origin, status, wealth, occupation, position, religion, opinion, or education.

16.2.Donor cell, tissue and organ transplantation, blood and blood product transfusion shall be carried out upon obtaining the written consent from the 18-year-old recipient as well as from the written consent of the parent, legal guardian, and custodian of the child and/or citizen without civil capacity.

16.3.The recipient shall strictly adhere to the rules and procedures issued by the regulatory office, and the advice of the professional team.

Article 17.Requirements on medical care institutions and their employees

17.1.Transplantation of donor cells, tissues, and organs shall be performed by a professional team with a permit to engage in the respective professional activities.

17.2.It shall be prohibited to the medical specialist involved in the transplantation of donor cells, tissues, and organs from receiving payment or incentives from the donor, the recipient, or their family members.

17.3.The doctor and health worker shall maintain the confidentiality of the donor and the recipient, and shall report pathological changes detected during the examination of the donor only to him/her.

CHAPTER FOUR

COLLECTION, ANALYSIS, PROCESSING, STORAGE, TRANSPORTATION, TRANSPLANTATION AND DISPOSAL OF BLOOD, CELLS, TISSUES AND ORGANS FROM THE DONOR

Article 18.Basic requirements for transplantation of donor cells, tissues, and organs

18.1.The compatibility of cells, tissues and organs of the donor and recipient, the analysis and transplantation of the cells, tissues and organs taken from the donor shall be performed by the professional team of the accredited health care institution, which has received a special permit from the state central administrative body in charge of health affairs.

18.2.Cells, tissues, and organs to be transplanted shall be taken from a non-living donor, and if taken from a living donor, they shall be taken from a family member who is compatible with cells and tissues and has no pathological changes.

18.3.It shall be prohibited to take cells, tissues, and organs from children for transplantation, except for bone grade, stem cells, bone marrow, and umbilical cord blood.

18.4.It shall be permitted to use gametes of one donor only for one live birth.

18.5.It shall be permitted to the woman who is determined by a medical opinion to be unable to conceive, carry a fetus or give birth on her own due to health reasons to have a child through a surrogate mother.

18.6.It shall be prohibited use embryos for people other than their parents.

18.7.Procedures for the use of donor gametes, embryo transplantation, care and services for the surrogate mother, and the model of the contract to be concluded between the parties shall be approved by the Cabinet member in charge of health affairs.

Article 19.Taking, analyzing, processing, storing, transporting, transplanting, and disposing the donor blood, cells, tissues, and organs for medical purposes

19.1.Procedures on obtaining, analyzing, processing, storing, transporting, transfusing, transplanting, and disposing blood, cells, tissues, and organs from donors shall be approved by the Cabinet member in charge of health affairs.

19.2.Accredited health care organizations with the special permit shall collect, analyze, store, and transport blood, blood products, donor cells, tissues, and organs in accordance with appropriate procedures.

Article 20.Passage of donor blood, blood products, cells, tissues, and organs across the state border

20.1.It shall be prohibited to export or import blood, blood products, cells, tissues and organs for profit.

20.2.It may be imported the certified tissues and organs, and be exported and imported blood and blood products only for medical purposes according to international treaties and transactions of Mongolia.

20.3.The procedures on the passage of donor blood, blood products, specimens, tissues, and organs across the state border shall be approved by the Government.

CHAPTER FIVE

EXPANDING THE LINE OF BLOOD DONORS

Article 21.Promotion and recruitment of blood donation

21.1.In order to expand the line of blood donors, promotion and recruitment of donors shall be organized in cooperation with the Mongolian Red Cross Society, state bodies,  non-governmental organizations, and business entities.

21.2.State bodies, non-governmental organizations, business entities, officials, and citizens shall support the organization in charge of blood issues in promoting activities and actions to expand the lines of donors and conducting training for them.

Article 22.Glorifying and rewarding citizens and organizations that have actively participated in blood donation

22.1.The procedure for providing discounted medical care and services to permanent and living blood donors, and free medical check-ups once a year shall be approved by the Cabinet member in charge of health affairs, and the procedure on free nursing care once a year for living donors and donors who have donated blood more than 35 times at an accredited domestic spa and sanatorium shall be approved by the Cabinet in charge of labor and social security affairs.

/This paragraph was amended by the law as of June 17, 2022/

22.2.Material, financial and psychological assistance may be provided for the purpose of glorifying and encouraging permanent and living blood donors, and may be rewarded by state bodies, non-governmental organizations, business entities, and organizations.

/This paragraph was amended by the law as of June 17, 2022/

22.3.The health care organization in charge of blood transfusion affairs shall operate a blood donor registration and information database, and shall constantly submit the information to the relevant organization.

CHAPTER SIX

MISCELLANEOUS

Article 23.Monitoring the implementation of the law

23.1.The state central administrative body in charge of health affairs and other relevant organizations shall monitor the implementation of the legislation on donor.

/This paragraph was amended by the law as of November 11, 2022/

Article 24.Lialities to be imposed on the violators of the Law

24.1.If the actions of officials who violate this Law shall not constitute criminal nature, they shall be held liable as provided in the Law on Civil Service.

24.2.Any person or legal entity who violates this Law shall be held liable as provided for in the Criminal Code or the Law on Violations.

THE CHAIRMAN OF THE STATE GREAT KHURAL OF MONGOLIA ENHBOLD.M