Circular 48/2024/TT-BYT providing the registration for transplantation, and principles of coordination in removal and transplantation, of tissues and organs from deceased donors

CIRCULAR

Providing the registration for transplantation, and principles of coordination in removal and transplantation, of tissues and organs from deceased donors

Pursuant to the November 29, 2006 Law on Donation, Removal and Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers;

Pursuant to the Government’s Decree No. 56/2008/ND-CP of April 29, 2008, providing the organization and operation of tissue banks and the National Coordination Center for Human Organ Transplantation;

Pursuant to the Government’s Decree No. 95/2022/ND-CP of November 15, 2022, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Department of Medical Service Administration,

The Minister of Health promulgates the Circular providing the registration for transplantation, and principles of coordination in removal and transplantation, of tissues and organs from deceased donors.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Circular provides:

a/ Registration of human tissue and organ transplantation;

b/ Principles of coordination in removal and transplantation of tissues and organs from deceased donors.

2. This Circular does not regulate the coordination in removal and transplantation of tissues and organs from living donors.

Article 2. Interpretation of terms

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

1. Hospital engaged in human tissue and organ donation means a medical establishment that accommodates brain-dead patients as donors of tissues and organs after death.

2. Hospital engaged in human tissue and organ transplantation means a medical establishment that has been licensed by a competent authority to perform human tissue and organ removal and transplantation.

Chapter II

REGISTRATION FOR TRANSPLANTATION, AND PRINCIPLES OF COORDINATION IN REMOVAL AND TRANSPLANTATION, OF TISSUES AND ORGANS FROM DECEASED DONORS

Article 3. Registration for human tissue and organ transplantation

1. In case it is determined through diagnosis that a patient receives indication and wishes for human tissue or organ transplantation, the medical examination and treatment establishment shall provide information about hospitals engaged in human tissue and organ transplantation for the patient to choose an appropriate hospital engaged in human tissue and organ transplantation.

2. The patient who receives indication and wishes for human tissue or organ transplantation shall submit a registration application for human tissue and organ transplantation, made according to the form provided in Appendix I to this Circular, to the hospital engaged in human tissue and organ transplantation.

3. If wishing to cancel his/her registration for human tissue or organ transplantation at any time, the patient shall submit a request for cancellation of the registration for human tissue or organ transplantation, made according to the form provided in Appendix I to this Circular, to the hospital engaged in human tissue and organ transplantation to which he/she has submitted the registration application.

4. After receiving the registration application for human tissue or organ transplantation, the hospital engaged in human tissue and organ transplantation has the following responsibilities:

a/ To provide medical examination and treatment for the patient and monitor the patient's condition;

b/ When the patient meets the Ministry of Health’s professional criteria for selecting human tissue or organ recipients, to include the patient's information in the hospital’s list of people awaiting tissue or organ transplantation and the national list of people awaiting tissue or organ transplantation.

5. Pending the transplantation, the hospital engaged in human tissue and organ transplantation shall remove the patient from its list of people awaiting tissue or organ transplantation, and update such information to the national list of people awaiting tissue or organ transplantation in the following cases:

a/ The patient submits a request for cancellation of the registration for human tissue or organ transplantation;

b/ The patient no longer meets the Ministry of Health’s professional criteria for selecting of human tissue and organ recipients;

c/ The patient fails to follow the instructions of the hospital engaged in human tissue and organ transplantation.

Article 4. Principles of coordination in removal and transplantation of tissues and organs from deceased donors

In addition to the principles specified in Article 37 of the Law on Donation, Removal and Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers, the coordination in human tissue and organ transplantation must adhere to the following principles:

1. Satisfying the conditions on the geographical distance and travel time from the medical establishment that accommodates potential brain-dead donors and the medical establishment expected to perform human tissue and organ transplantation.

2. Taking into account the wish of the human tissue and organ donor or the wish of his/her family, unless such wish is contrary to law.

Chapter III

IMPLEMENTATION PROVISIONS

Article 5. Effect

This Circular takes effect on March 1, 2025.

Article 6. Responsibilities of the Department of Medical Service Administration

1. To act as the focal-point agency in directing and organizing the implementation of this Circular; and provide professional instructions within the ambit of its assigned functions and tasks.

2. To urge the implementation of this Circular according to its assigned functions and tasks.

Article 7. Responsibilities of the National Coordination Center for Human Organ Transplantation

In addition to the functions and tasks specified in Article 36 of the Law on Donation, Removal and Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers, the National Coordination Center for Human Organ Transplantation has the following tasks:

1. To coordinate the removal, transplantation, preservation, storage and transportation of human tissues and organs.

2. To establish an online system for registration for human tissue and organ donation and transplantation.

3. To publicly announce the list of hospitals engaged in human tissue and organ transplantation on the online system for registration for human tissues and organ donation and transplantation.

4. To assume the prime responsibility for, and coordinate with hospitals engaged in human tissue and organ transplantation in, developing guidelines on determination of the order of priority for human tissue and organ transplantation for submission to the Ministry of Health for promulgation.

5. To inspect and supervise the registration for human tissue and organ transplantation and the coordination in removal and transplantation of human tissues and organs at medical establishments.

6. To carry out public communications about donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers, and carry out public communications for honoring donors and conferring commemorative medals for donors.

Article 8. Responsibilities of hospitals engaged in human tissue and organ transplantation

1. To form divisions, or assign units or arrange personnel for managing patients awaiting transplantation of human tissues and organs; to cooperate with the National Coordination Center for Human Organ Transplantation in coordinating the removal and transplantation of human tissues and organs.

2. To make lists of people awaiting tissue or organ transplantation and update them to the national list of people awaiting tissue or organ transplantation.

3. To report to the National Coordination Center for Human Organ Transplantation on the process of their participation in coordination activities and performance of human tissue and organ transplantation.

Article 9. Responsibilities of hospitals engaged in human tissue and organ donation

1. To form divisions or assign units or arrange personnel for providing counseling on and mobilizing donation of human tissues and organs.

2. To organize honoring of human tissue and organ donors.

3. To coordinate with hospitals engaged in human tissue and organ transplantation and the National Coordination Center for Human Organ Transplantation in providing counseling on donation, removal and transplantation of human tissues and organs and donation and recovery of cadavers.

Any problems arising in the course of implementation of this Circular should be reported to the Ministry of Health (the Department of Medical Service Administration) for guidance or consideration and settlement.-

For the Minister of Health

Deputy Minister

TRAN VAN THUAN

* The Appendices to this Circular are not translated.