Law on donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers

Pursuant to the 1992 Constitution of the Socialist Republic of Vietnam, which was amended and supplemented under Resolution No. 51/2001/QH10 of December 25, 2001, of the Xth National Assembly, the 10th session;

This Law provides for the donation, removal and transplantation of human tissues and organs and the donation and recovery of cadavers.

Chapter I

GENERAL PROVISIONS

Article 1.-

 

Scope of regulation

1. This Law provides for the donation, removal and transplantation of human tissues and organs and the donation and recovery of cadavers; the organization and operation of tissue banks and the National Coordination Center for Organ Transplantation.

2. Blood transfusion and bone marrow transplantation are not governed by this Law.

Article 2.-

 

Subjects of application

This Law applies to Vietnamese organizations and individuals, overseas Vietnamese, and foreign organizations and individuals related to the donation, removal and transplantation of human tissues and organs and the donation and recovery of cadavers in Vietnam.

Article 3.-

 

Interpretation of terms

In this Law, the terms below are construed as follows:

1. Tissue is a combination of cells of the same type or different types to perform certain functions of human body.

2. Human organ is a part of human body formed from tissues of different types to perform certain physiological functions.

3. Ovum is a reproductive cell.

4. Embryo is a product of the process of development as a result of combination between an egg and a sperm.

5. Non-regenerable organ is an organ that the body cannot produce or develop another one to replace it after that organ is removed from the body.

6. Donation of human tissues or organs is an act whereby individuals voluntarily donate their tissues or organs when they are living or after their death.

7. Removal of human tissues or organs is the separation of tissues or organs from living or deceased donors.

8. Transplantation of human tissues or organs is the transplantation of corresponding tissues or organs of a donor's body into the transplant recipient's body.

9. Brain death is the state when the whole brain is severely damaged, the brain stops functioning and the brain-dead person cannot be revived.

10. Tissue bank is an establishment that receives, preserves, stores, transports and supplies tissues.

Article 4.-

 

Principles in the donation, removal and transplantation of human tissues and organs and the donation and recovery of cadavers

1. Voluntariness of donors and transplant recipients.

2. For humanitarian purposes, medical treatment, lecturing or scientific research.

3. For non-commercial purposes.

4. Confidentiality of information relating to donors and transplant recipients, unless otherwise agreed upon by the involved parties or provided for by law.

Article 5.-

 

The right to donate human tissues and organs and cadavers

Those who are full eighteen years or older and have full civil act capacity are entitled to donate human tissues and organs when they are living or after their death and to donate their cadavers.

Article 6.-

 

The right to donate and receive sperm, ova and embryos in artificial fertilization

1. Men aged full twenty years or older and women aged full eighteen years or older and having full civil act capacity are entitled to donate and receive sperm, ova or embryos in artificial fertilization in accordance with law.

2. Donation and receipt of sperm, ova and embryos in artificial fertilization shall be carried out according to the Government's regulations.

Article 7.-

 

Responsibilities for state management of donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers

1. The Government performs uniform state management of donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

2. The Ministry of Health is responsible to the Government for performing the state management of donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers nationwide.

3. Ministries and ministerial-level agencies shall, within the scope of their respective tasks and powers, coordinate with the Ministry of Health in performing the state management of donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

4. People's Committees at all levels shall, within the scope of their tasks and powers, perform the state management of donation, removal and transplantation of human tissues and organs and donation and receipt of cadavers.

Article 8.-

 

Contents of state management of donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

1. Promulgating, and organizing the implementation of, legal documents on donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

2. Making, and directing the implementation of, plans on donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

3. Propagating and disseminating the law on donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

4. Organizing and directing the training and retraining of managerial and professional personnel in donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

5. Mobilizing, managing and utilizing resources for donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

6. Organizing and managing scientific and technological research and application related to donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

7. Inspecting and supervising the observance of the law on donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

8. Settling complaints and denunciations about and handling violations of the law on donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

9. Undertaking international cooperation on donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

Article 9.-

 

Information and communication about donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

1. State agencies, the Vietnam Fatherland Front and its member organizations, social organizations, economic organizations and people's armed force units shall, within the scope of their respective tasks and powers, provide information on the humanitarian, medical treatment, lecturing and scientific research purposes and the significance of donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

2. The Ministry of Health shall assume the prime responsibility for, and coordinate with the Ministry of Culture and Information in, providing the mass media information on the humanitarian, medical treatment, lecturing and scientific research purposes and the significance of donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

3. The Ministry of Culture and Information shall direct the mass media to regularly disseminate information on humanitarian, medical treatment, teaching and scientific research purposes and the significance of donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

4. People's Committees at all levels shall conduct information and communication work on humanitarian, medical treatment, teaching and scientific research purposes and the significance of donation, removal and transplantation of human tissues and organs and donation and receipt of cadavers in localities.

Article 10.-

 

State policies on donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers

1. To invest in or support investment in medical establishments to research, remove, transplant, preserve and store human tissues and organs;

2. To support research and application of advanced scientific and technological achievements, training, exchange of specialists, technology transfer in the removal, transplantation, preservation and storage of human tissues and organs.

3. To encourage domestic and foreign organizations and individuals to invest in and cooperate on the research, removal, transplantation, preservation and storage of human tissues and organs.

4. To support the work of information and communication on the donation, removal, transplantation, preservation and storage of human tissues and organs.

5. To support resources for tissue and organ research, culture and transplantation.

6. To take care of the health of voluntary donors from whom tissues and organs have been removed in accordance with law.

7. To honor donors who have voluntarily donated their organs or their cadavers.

Article 11.-

 

Prohibited acts

1. To steal human tissues and organs; to steal cadavers.

2. To force other persons to give away their tissues and organs or remove tissues and organs from persons who refuse to donate their tissues and organs.

3. To buy or sell human tissues and organs; to buy or sell cadavers.

4. To remove, transplant, use or store human tissues and organs for commercial purposes.

5. To remove tissues and organs from living persons aged under 18 years.

6. To transplant tissues or organs of persons infected with diseases on the list prescribed by the Minister of Health.

7. To implant sperm, ova and embryos between persons of the direct bloodline and between persons of different sexes who are next of kin within three generations.

8. To advertise and act as intermediaries in the donation and removal of human organs for commercial purposes.

9. To disclose information and secrets about donors and transplant recipients in violation of law.

10. To abuse one's position and powers to distort the results of brain death determination.

Chapter II

DONATION AND REMOVAL OF LIVING DONOR TISSUES AND ORGANS

Section 1. Registration of donation of living donor tissues and organs

Article 12.-

 

Procedures for registration of donation of living donor tissues and organs

1. Those who are eligible under Article 5 of this Law are entitled to express their wish to donate their tissues and organs to a medical establishment.

2. The medical establishment shall report information on a person who wishes to donate his/her tissues or organs to the National Coordination Center for Human Organ Transplantation.

3. Upon receiving the notice on a person who wishes to donate his/her tissues or organs, the National Coordination Center for Human Organ Transplantation shall notify a medical establishment defined in Article 16 of this Law to carry out donation registration procedures for that person.

4. Upon receiving the notice of the National Coordination Center for Human Organ Transplantation, a medical establishment defined in Article 16 of this Law shall:

a/ Directly meet with the donor and provide him/her with information about human tissue and organ donation and removal;

b/ Give guidance on the donation registration according to a set form; to conduct health checks of the donor;

c/ Report the list of registered living donors of tissues or organs to the National Coordination Center for Organ Transplantation.

5. Registration of donation of living donor tissues or organs becomes effective at the time the medical establishment receives the written registration of donation of tissues or organs by a living donor.

6. The Minister of Health shall prescribe the form of registration of donation of living donor tissues or organs; and the counseling and health check of living donors.

Article 13.-

 

Procedures for modification or cancellation of written registrations of donation of living donor tissues or organs

1. When wishing to modify or cancel his/her written registration of donation of tissues or organs, a registered donor shall send a written request for modification or cancellation to the medical establishment that has received his/her donation registration.

2. The medical establishment mentioned in Clause 1 of this Article shall:

a/ Receive the written request for modification or cancellation of the donation registration;

b/ Within two working days after receiving the written request, notify the National Coordination Center for Human Organ Transplantation of the modification or cancellation of the donation registration.

3. Modification or cancellation of a written registration of donation of living donor tissues or organs becomes effective at the time the medical establishment receives the written request for modification or cancellation of the donation registration.

4. The Minister of Health shall prescribe the form of request for modification or cancellation of a written registration of donation of living donor tissues or organs.

Section 2. Removal of living donor tissues or organs

Article 14.-

 

Conditions and procedures for removal of living donor tissues or organs

1. Only medical establishments specified in Article 16 of this Law may remove tissues or organs from living donors.

2. Tissues and organs may be removed only from living donors who have made donation registration. In emergency cases where it is necessary to transplant tissues or transplant tissues for a parent or sibling, it is permitted to remove tissues from a person who has not yet made donation registration when so consented by this person.

3. Before removing tissues or organs from a living donor, a medical establishment shall:

a/ Give counseling on health and social psychology to the donor;

b/ Examine biological parameters of the donor.

4. The Minister of Health shall make specific regulations on the counseling and examination of biological parameters of living donors.

Article 15.-

 

Conditions and procedures for removal of non-regenerable organs from living donors

1. Removal of non-regenerable organs from living donors must comply with the provisions of Article 14 of this Law and may be carried out only after obtaining the written approval of a Counseling Council on Human Organ Removal and Transplantation.

2. A Counseling Council on Human Organ Removal and Transplantation shall be established by a medical establishment specified in Article 16 of this Law. It must be composed of at least five members who are medical, legal and psychological professionals.

3. The Minister of Health shall make specific regulations on the organization and operation of a Counseling Council on Human Organ Removal and Transplantation.

Article 16.-

 

Conditions on medical establishments engaged in human organ removal and transplantation

1. A medical establishment engaged in human organ removal and transplantation must fully meet the following conditions:

a/ Having sufficient medical personnel who are professionally capable and qualified in human organ removal and transplantation, anesthesia and post-transplantation recovery as evidenced in specialty certificates or diplomas granted by medical establishments or training institutions.

b/ Having the chief of the human organ transplantation team who has personally engaged in transplant operations on humans;

c/ Having at least three sterilized closed inter-related rooms arranged in a one-way direction, including a room for human organ removal, treatment and preservation, a room for transplantation, and a room for post-transplantation recovery;

d/ Having a technical room exclusively used for the constant supervision of and care for donors or transplant recipients;

e/ Having an experimental transplantation unit;

f/ Having a testing room;

g/ Having a blood ventilation and dialysis unit for kidney transplantation;

h/ Having adequate medical equipment and instruments of functional exploration, hematology, biochemistry, microbiology, immunology, pathological surgery, diagnostic radiography, and quantification of anti-rejection drugs to ensure the diagnosis and supervision of donors and recipients before, during and after transplantation;

i/ Having sufficient medicines and drugs to meet the requirements of the process of removal, transplantation and post-transplantation recovery.

2. The Minister of Health shall make specific regulations on the conditions specified in Clause 1 of this Article; conditions of medical establishments engaged in tissue removal and transplantation; order and procedures for licensing the operation of medical establishments engaged in human organ removal and transplantation and medical establishments engaged in tissue removal and transplantation.

Article 17.-

 

Benefits of donors from whom tissues or organs have been removed

1. Donors are entitled to free health care and rehabilitation right after their tissues are removed at medical establishments;

2. Donors from whom organs have been removed are entitled to the following benefits:

a/ Free health care and rehabilitation right after their tissues are removed at medical establishments and free regular health checks;

b/ Free health insurance cards;

c/ Prioritized transplantation of human tissues or organs at the prescription of a medical establishment;

d/ Receipt of a For the People's Health medal according to regulations of the Minister of Health.

3. The Minister of Finance shall make specific regulations on the financial regime applicable to regular health checks and the issuance of health insurance cards to donors who have donated their organs.

Chapter III

DONATION, REMOVAL OF DECEASED DONOR TISSUES AND ORGANS, AND DONATION AND RECOVERY OF CADAVERS

Section 1. Registration of donation of deceased donor tissues and organs and donation of cadavers

Article 18.-

 

Procedures for registration of donation of deceased donor tissues and organs

1. Persons who meet all conditions specified in Article 5 of this Law are entitled to express their wish to donate their tissues or organs after their death to a medical establishment.

2. When receiving information from a person who wishes to donate his/her tissues or organs after his/her death, a medical establishment shall notify the National Coordination Center for Human Organ Transplantation.

3. When receiving a notice on a case of human tissue or organ donation, the National Coordination Center for Human Organ Transplantation shall notify a medical establishment defined in Article 16 of this Law for carrying out donation registration procedures for the donor.

4. When receiving the notice of the National Coordination Center for Human Organ Transplantation, a medical establishment defined in Article 16 of this Law shall:

a/ Directly meet the donor to give counseling on human tissue and organ transplantation and removal;

b/ Instruct the donation registration according to a set form; conduct a health check of the donor;

c/ Issue a card of registration of donation of deceased donor tissues and organs to the donor;

d/ Report the list of registered donors who have been granted a card of donation of deceased donor tissues and organs to the National Coordination Center for Human Organ Transplantation.

5. Registration of donation of deceased donor tissues or organs becomes effective on the date the registrant is issued a donation registration card.

6. The Minister of Health shall prescribe the form of registration of donation of deceased donor tissues and organs; counseling for and health checks of persons who will donor their tissues or organs after death.

Article 19.-

 

Procedures for registration of cadaver donation

1. Persons who meet all conditions specified in Article 5 of this Law are entitled to express their wish to donate their cadavers to a medical establishment.

2. When receiving information from a person who wishes to donate his/her cadaver, a medical establishment shall notify an establishment engaged in cadaver recovery and preservation defined in Article 23 of this Law.

3. When receiving a notice on a case of cadaver donation, an establishment engaged in cadaver recovery and preservation shall:

a/ Directly meet the donor to give counseling on cadaver donation;

b/ Instruct the donation registration according to a set form;

c/ Issue a card of registration of cadaver donation to the donor;

4. Registration of cadaver donation becomes effective on the date the registrant is issued a cadaver donation registration certificate.

5. The Minister of Health shall prescribe the form of registration of cadaver donation and the counseling on cadaver donation.

Article 20.-

 

Procedures for modification or cancellation of applications for registration of donation of deceased donor tissues and organs or donation of cadavers

1. When wishing to modify or cancel his/her application for registration of donation of deceased donor tissues or organs or cadaver donation, the registered person shall send a written request for modification or cancellation to a medical establishment or an establishment engaged in cadaver recovery and preservation that has received his/her application.

2. The medical establishment or establishment engaged in cadaver recovery and preservation mentioned in Clause 1 of this Article shall:

a/ Receive the written request for modification or cancellation of registration of donation of deceased donor tissues or organs or cadaver donation from the registered donor.

b/ Re-issue a card of registration of donation of deceased donor tissues or organs or cadaver donation to the registered donor or withdraw the card from the registered donor who has been issued such card;

c/ Within two working days after receiving the written request, notify the National Coordination Center for Organ Transplantation of the modification or cancellation of the applications for registration of donation of deceased donor tissues or organs.

3. Modification or cancellation of an application for registration of donation of deceased donor tissues or organs or cadaver donation becomes effective from the time the medical establishment or the establishment engaged in cadaver recovery and preservation receives the written request for modification or cancellation of the registration application.

4. The Minister of Health shall prescribe the form of request for modification or cancellation of the application for registration of donation of deceased donor tissues or organs or cadaver donation.

Section 2. REMOVAL OF DECEASED DONOR TISSUES OR ORGANS, RECOVERY OF CADAVERS

Article 21.-

 

Removal of deceased donor tissues or organs

1. Only medical establishments defined in Article 16 of this Law may remove tissues and organs from deceased donors.

2. Removal of tissues and organs from deceased donors may be carried out in the following cases:

a/ The deceased donor has a card of registration of donation of deceased donor tissues or organs;

b/ The deceased donor has a card of registration of donation of deceased donor tissues or organs and has been declared brain-dead under the provisions of Clause 5, Article 27 of this Law;

c/ In case of having no card of registration of donation of deceased donor tissues or organs, written consent of the father, mother, guardian, spouse or adult child of the deceased donor is required.

Article 22.-

 

Conditions for cadaver recovery

1. Only medical establishments engaged in recovery and preservation of donor cadaver defined in Article 23 of this Law may recover cadavers.

2. The recovery of cadavers may be conducted in the following cases:

a/ The deceased has a card of registration of donation of his/her cadaver;

b/ In case the deceased has no card of registration of donation of his/her cadaver, written consent of the father, mother, guardian, spouse or adult child of the deceased donor is required;

c/ The deceased's last residence is unknown but there is a death certificate issued by the People's Committee of the commune, ward or township where the person dies.

Article 23.-

 

Conditions for establishments engaged in recovery and preservation of donor cadavers

Establishments engaged in recovery and preservation of donor cadavers are medical research and training institutions that have adequate conditions on material foundations for cadaver preservation, equipment, facilities, personnel and a memorial room according to the Health Minister's regulations.

Article 24.-

 

Responsibilities of medical establishments and establishments engaged in recovery and preservation of donor cadavers in removing deceased donor tissues and organs or recovering cadavers.

1. Medical establishments and establishments engaged in recovery and preservation of donor cadavers have the following responsibilities:

a/ To visit the places where cadavers exist to remove organs from or recover cadavers;

b/ To collaborate with deceased donors' families in holding memorial services for the deceased;

c/ Restoring the appearance of cadavers after removing organs therefrom or no longer needing to use cadavers;

d/ Organizing burial services for cadavers which are no longer needed for use.

2. Expenses for organizing memorial and burial services for donor cadavers shall be borne by the state budget according to the Health Minister's regulations.

Article 25.-

 

Honoring of deceased donors for donation of their organs or cadavers

Deceased donors of organs or cadavers shall be posthumously awarded a For the People's Health medal according to the Health Minister's regulations.

Section 3. Death brain

Article 26.-

 

Purposes of and conditions for determining brain death

1. Brain death determination is a legal ground for removing tissues or organs from persons with cards of registration of donation of deceased donor tissues or organs.

2. Conditions for brain death determination include:

a/ Satisfying all indicators of brain death according to Articles 28 and 29 of this Law;

b/ Three professionals defined in Clause 3, Article 27 of this Law have personally conducted examination and conclusion on brain death;

c/ Brain death diagnosis may be conducted only at a medical establishment with an intensive care unit, ventilators, breath and blood analyzers and other conditions as specified in Article 16 of this Law.

Article 27.-

 

Procedures and competence to determine brain death

1. Heads of medical establishments defined at Point c, Clause 2, Article 26 of this Law shall issue decisions approving lists of professionals to participate in brain death determination.

2. Professionals in brain death determination are those in the following fields:

a/ Intensive care;

b/ Neurology or neurosurgery;

c/ Forensic examination.

3. For brain death determination, the head of a medical establishment defined in Clause 1 of this Article shall appoint a group of three professionals on the list of professionals participating in brain death determination in the three fields specified in Clause 2 of this Article. The physician who will personally participate in tissue or organ transplantation and the physician who is personally attending to the brain-dead person may not participate in the group of professionals for brain death determination.

4. Brain death conclusions by the group of brain death determination professionals may be publicized only after there are written brain death conclusions of all three members.

Members of the group of brain death determination professionals shall take responsibility before law for the scientificity and accuracy of their brain death conclusions.

5. The head of the medical establishment defined in Clause 1 of this Article shall publicize in writing brain death conclusions.

Article 28.-

 

Clinical criteria and time criteria for brain death determination

1. Clinical criteria for brain death determination include:

a/ Coma (the score of 3 on the Glasgow coma scale);

b/ Fixed pupil (the pupil's diameter dilated to both sides over 4 mm);

c/ No pupillary reflex to light;

d/ No corneal reflex;

e/ No cough response to stimulation of bronchi;

f/ No deviation of the eyes to irrigation of each ear with 50 ml of cold water;

g/ Loss of the breathing ability when the ventilator is disconnected.

2. The time criterion for brain death determination is that conclusion on brain death can be made only at least 12 hours after the moment all clinical criteria specified in Clause 1 of this Article are satisfied and no recovery is observed.

3. The Ministry of Health shall specify cases where the clinical criteria specified in Clause 1 of this Article are not applicable to death brain determination.

Article 29.-

 

Subclinical criteria for determining brain death

1. In order to identify subclinical criteria for determining brain death, one of the following professional techniques shall be used:

a/ Electroencephalogram (EEG);

b/ Computed tomography scanning;

c/ Transcranial Doppler ultrasonography;

d/ X-ray of brain arteries;

e/ Nuclear brain scanning.

2. The Minister of Health shall specify subclinical criteria for determining brain death and the application of professional techniques mentioned in Clause 1 of this Article.

Chapter IV

TRANSPLANTATION OF HUMAN TISSUES AND ORGANS

Article 30.-

 

Conditions on potential transplant recipients

1. Having a medical establishment's prescription for human tissue or organ transplantation.

2. Filing a voluntary application for transplantation. Written consent of the father, mother or guardian is required for recipients aged under 18 years.

3. For the transplantation of a non-regenerable organ from a living donor, written approval of a counseling council on removal and transplantation of organs defined in Article 15 of this Law is required.

Article 31.-

 

Conditions on medical establishments allowed to carry out human tissue and organ transplantations

Only medical establishments defined in Article 16 of this Law may carry out human tissue and organ transplantations.

Article 32.-

 

Post-transplantation medical care

1. Transplant recipients are entitled to post-transplantation medical care; regular health monitoring and examinations at the medical establishment that has conducted the transplantations or a medical establishment allowed to carry out human tissue and organ transplantations.

3. Medical establishments allowed to carry out human tissue and organ transplantations shall provide medical care for persons defined in Clauses 1 and 2 of this Article.

4. The Minister of Health shall specify the professional process of providing medical care for transplant recipients.

Article 33.-

 

Health insurance regime and hospital charges for transplant recipients

1. Transplant recipients who have health insurance cards shall have hospital charges for their transplantation paid by the health insurance agency according to the law on health insurance.

2. Transplant recipients who have no health insurance cards shall pay hospital charges.

Article 34.-

 

Organ transplantation related to foreigners

1. Foreigners and overseas Vietnamese may be transplanted with organs of Vietnamese in Vietnam if they have the same bloodline with or are next of kin within three generations of donors or when donors have filed voluntary donation applications without identifying recipients' names.

2. Vietnamese may go abroad for donating their organs if they have the same bloodline with or are next of kin within three generations of transplant recipients.

Chapter V

TISSUE BANKS AND NATIONAL COORDINATION CENTER FOR ORGAN TRANSPLANTATION

Article 35.-

 

Tissue bank

1. Tissue bank is a medical establishment set up by an agency, an organization or an individual.

2. A tissue bank may receive, preserve, store and transport tissues; supply tissues for medical establishments or medical research and training institutions; and undertake international cooperation in the exchange of tissues.

3. Conditions for establishing a tissue bank:

a/ Having all conditions of material foundation, equipment, facilities and personnel under the provisions of Clause 6 of this Article;

b/ Professional managers of a tissue bank must satisfy all criteria specified in Clause 4 of this Article.

4. Criteria for a professional manager of a tissue bank:

a/ Having a bachelor degree in medicine, pharmacy, biology or chemistry;

b/ Having worked for three or more years in a medical, biological or chemical establishment;

c/ Observing professional ethics;

d/ Being physically fit for the profession;

e/ Facing no ban on practicing his/her profession or doing a job related to his/her profession under a court judgment or ruling; not being subjected to penal liability examination; not currently serving a criminal sentence or a decision on the administrative sanction of confinement to an educational or medical treatment institution; not being subjected to a discipline of caution or severer form related to professional activities; not having lost civil act capacity or a restricted civil act capacity.

5. A tissue bank has the legal person status and may operate only after obtaining a license from the Ministry of Health.

6. The Minister of Health shall provide for material foundations, equipment, facilities, personnel of tissue banks, and dossiers and procedures for licensing tissue banks.

7. A tissue bank operates for non-commercial purposes. The Government shall specify forms of organization and operation of tissue banks in accordance with the situation of socio-economic development.

Article 36.-

 

The National Coordination Center for Human Organ Transplantation

1. The National Coordination Center for Human Organ Transplantation is a non-business organization that has the legal capacity and is attached to the Ministry of Health.

2. The National Coordination Center for Human Organ Transplantation has the following functions and tasks:

a/ Receiving and processing information on donation, modification or cancellation of donation of human tissues and organs;

b/ Managing the national list of people waiting for tissue or organ transplantation;

c/ Managing the grant of cards of donation of deceased donor tissues or organs and cadaver donation;

d/ Managing information on tissue and organ donors and transplant recipients;

e/ Coordinating the removal, transplantation, preservation, storage and transport of human tissues and organs;

f/ Undertaking international cooperation on coordination of human tissue and organ removal and transplantation.

3. The Government shall decide on the establishment of the National Coordination Center for Human Organ Transplantation and specify the organization and operation of the Center.

Article 37.-

 

Principles of coordination of human tissue and organ removal and transplantation

1. Coordination of human tissue and organ removal and transplantation must ensure compatibility between donors and potential transplant recipients and equality between transplant recipients.

2. The priority order of human tissue and organs transplantation is provided as follows:

a/ Children;

b/ Emergency cases;

c/ Persons who have donated their organs upon transplantation prescription or persons topping the list of persons waiting for transplantation compiled by the National Coordination Center for Human Organ Transplantation or at medical establishments engaged in human tissue and organ removal and transplantation.

d/ If there are many persons having the same biological parameters with a donor, priority shall be given to the person on the waiting list of the medical establishment that has removed an organ of this donor.

Article 38.-

 

Encryption

1. All information on organ donors and recipients shall be encrypted and kept confidential.

2. In case of disclosure of information mentioned in Clause 1 of this Article, anonymity must be ensured to keep donors and recipients unidentifiable, unless donors and recipients have the same bloodline or are next of kin within three generations.

3. Only in special cases, for medical treatment purposes and at the request of the head of the medical establishment or the legal procedure-conducting body, can the information-keeping establishment supply information.

4. Files of donors and recipients shall be stored and preserved for thirty years.

Chapter VI

IMPLEMENTATION PROVISIONS

Article 39.-

 

Implementation effect

This Law takes effect on July 1, 2007.

Article 40.-

 

Implementation guidance

The Government shall detail and guide the implementation of this Law.

This Law was passed on November 29, 2006, by the XIth National Assembly of the Socialist Republic of Vietnam at its 10th session.