Consolidated Document number 5/VBHN-BYT on the organization and operation of stem cell banks and the National Center for Human Organ Transplantation Coordination.

CIRCULAR

REGULATIONS ON THE ESTABLISHMENT, ORGANIZATION AND OPERATIONS OF THE SPECIALIZED ADVISORY BOARD FOR ASSESSING CAUSES OF SEVERE ADVERSE EVENTS FOLLOWING IMMUNIZATION

Circular No. 24/2018/TT-BYT dated September 18, 2018, issued by the Minister of Health, stipulating the establishment, organization, and operation of the Expert Advisory Board for evaluating the causes of severe adverse events following immunization, effective from November 15, 2018, has been amended and supplemented by:

Circular No. 05/2020/TT-BYT dated April 3, 2020, issued by the Minister of Health, amending and supplementing certain provisions of Circular No. 24/2018/TT-BYT dated September 18, 2018, issued by the Minister of Health, stipulating the establishment, organization, and operation of the Expert Advisory Board for evaluating the causes of severe adverse events following immunization, effective from June 1, 2020.

Pursuant to the Law on Prevention and Control of Infectious Diseases 2007;

Pursuant to the Government's Decree No. 75/2017/NĐ-CP dated June 20, 2017 stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government on immunization activities;

At the proposal of the Director of the Preventive Medicine Department, Ministry of Health;

The Minister of Health promulgates this Circular stipulating the establishment, organization, and operation of the Expert Advisory Board for evaluating the causes of severe adverse events following immunization.[1]

2. Tasks of the Central Board

a) To assess the situation of severe adverse events following immunization nationwide, monitor post-immunization reactions, and make recommendations to the Provincial Boards;

2. The Director of the Department of Health shall establish the Expert Advisory Board for evaluating the causes of severe adverse events following immunization at the provincial level (hereinafter referred to as the Provincial Advisory Board).

3. Authorities of the Central Board

a) To request the Provincial Board, relevant organizations, individuals, and units to provide information related to severe adverse events following immunization;

Provide expert advice to the Minister of Health in handling cases of severe adverse events following immunization according to Article 6 of Decree No. 104/2016/NĐ-CP dated July 1, 2016, issued by the Government, stipulating immunization activities.

4. Composition of Members of the Central Board

The Central Board shall have at least 17 members meeting the criteria specified in Clause 5 of this Article, ensuring the following composition:

a) Chairman: Director of the Preventive Medicine Department;

b) Deputy Chairmen: Leaders of the Preventive Medicine Department; Leaders of the Department of Medical Examination and Treatment; and Leaders of the National Institute of Hygiene and Epidemiology;

c) Members of the Board: Representatives of the Department of Medicines Management; the Department of Science, Technology and Training; the Department of Medical Examination and Treatment; the Legal Affairs Department; Bach Mai Hospital; Vietnam National Children's Hospital; Vietnam National Obstetrics and Gynecology Hospital; National Institute of Hygiene and Epidemiology; National Institute of Hygiene and Epidemiology West Region; Ho Chi Minh City Pasteur Institute; Nha Trang Pasteur Institute; National Institute for Vaccine and Biomedical Research; Medical Forensic Institute;

d) In case of necessity and depending on specific circumstances, the Chairman of the Central Board may invite additional experts in finance, forensic pathology, emergency care, law, and other fields related to severe adverse events following immunization to join the Board.

5. Criteria for Members of the Central Board

a) Having necessary experience, knowledge, and skills related to assessing causes of severe adverse events following immunization;

a)[2] Chairman of the Board: An independent expert with credibility in the field of immunization and not belonging to the National Regulatory Authority (NRA) of Vietnam;

b)[3] Vice-Chairman of the Board: A leader from a central hospital specializing in pediatrics or infectious diseases;

c)[4] Members of the Board:

- Representatives from the Department of Medical Examination and Treatment, the Legal Affairs Department, and the Planning and Finance Department.

- Experts from the Institute of Hygiene and Epidemiology, Pasteur Institutes, representatives from medical universities, experts in pharmaceuticals, vaccines, and epidemiology.

- Clinical experts in obstetrics, immunology, pediatrics, and emergency care from hospitals, one to two persons per unit.

The Chairman of the Board establishes a Secretariat including representatives from the Preventive Medicine Department, the Central Institute of Hygiene and Epidemiology. The Secretariat's duties include collecting and compiling relevant materials related to severe adverse events following immunization, preparing meeting agendas, and finalizing meeting minutes after each session.

d) In necessary cases and depending on specific circumstances, the Chairman of the Ministry-level Board may invite additional experts in finance, forensic medicine, emergency care, law, and other relevant fields concerning severe adverse events following immunization to join the Board.

5. Criteria for members of the Ministerial-level Council

a) Possessing necessary experience, knowledge, and skills related to evaluating causes of severe adverse events following immunization;

b) Individuals involved in vaccination activities shall not participate in the Council membership.

Article 3. Functions, tasks, powers, and membership structure of the Provincial Council

1. Functions of the Provincial Council

Providing specialized advice to the Director of the Department of Health in handling severe adverse events following immunization within the managed area.

2. Tasks of the Provincial Council

a) Implementing the tasks specified in points a, b, and c, Clause 1, Article 6 of Decree No. 104/2016/NĐ-CP dated July 1, 2016, of the Government on immunization activities;

b) Regularly assessing the situation of severe adverse events following immunization within the managed area.

3. Powers of the Provincial Council

a) Requesting organizations, individuals, and relevant units to provide information related to severe adverse events following immunization;

b) Ensuring conditions for performing tasks;

c) Proposing the Central Council to re-evaluate the conclusions of the Provincial Council when necessary.

4. Membership structure of the Provincial Council

The Provincial Council shall have at least ten members meeting the criteria stipulated in Clause 5 of this Article, ensuring the following composition:

a)[5] Chairman of the Board: A leader from the Department of Health;

b)[6] Vice-Chairman of the Board: A leader from a provincial general hospital or regional general hospital;

c)[7] Members of the Board:

- Leaders of the Medical Services Department - Provincial Health Department, Pharmaceutical Services Department - Provincial Health Department;

- Clinical experts in obstetrics, pediatrics, and emergency care at provincial general hospitals, provincial maternity and children's hospitals, or pediatric hospitals, or obstetrics and pediatrics departments within provincial general hospitals, or provincial reproductive health centers, Institute of Hygiene and Epidemiology, Pasteur Institutes, based on management regions;

The Chairman of the Board establishes a Secretariat including representatives from the Department of Health, the Provincial Center for Disease Control/Preventive Medicine, and the provincial general hospital. The Secretariat's duties include collecting and compiling relevant materials related to severe adverse events following immunization, preparing meeting agendas, and finalizing meeting minutes after each session.

d) In necessary cases and depending on specific circumstances, the Chairman of the Provincial-level Board may invite additional experts in finance, forensic medicine, emergency care, law, and other relevant fields concerning severe adverse events following immunization to join the Board.

5. Criteria for members of the Provincial Council

a) Having necessary experience, knowledge, skills, and capability related to evaluating the causes of severe adverse events following immunization;

b) Individuals who carry out immunization activities in the province shall not participate in the Council's membership.

Article 4. Provisions on the operation of the Council

1. Principles of Council operation

a) The Council operates under a collective system, objectively and independently;

b) The conclusion of the Board is based on the majority opinion of the Board members (two-thirds of the voting opinions of the Board members at the meeting). In case there is no agreement among two-thirds of the voting members, the Chairman will make the decision.

2. Methods of Council operation

a) The Board operates through meetings. The Board only convenes when at least two-thirds of the official members are present. In case a member is absent, they must provide a reason and authorize another person to attend in writing, with the consent of the Chairman. The authorized person must meet the standards of Board members as stipulated in Clause 5 of Article 2 and Clause 5 of Article 3 of this Circular and participate in voting as an official member;

b) All discussion contents, including dissenting opinions with the Board's conclusions and recommendations, must be fully recorded in the meeting minutes. The meeting minutes of the Ministry-level Board must be established in two copies, one retained by the Board's permanent office and the other reported to the Ministry leadership. The meeting minutes of the Provincial-level Board must be established in two copies, one retained by the Provincial-level Board's permanent office and the other reported to the Provincial Health Department Director.

3. Councils at all levels convene regularly once every six months, mid-year and end-of-year; convene urgently upon the proposal of the Council's permanent body when there are issues to resolve.

4. The Council's operating budget is allocated from the annual health service budget and other sources (if any).

Article 5. Standing Committees at all levels

1. The permanent office assisting the Ministry-level Board is located at the Preventive Medicine Department and uses the Preventive Medicine Department's seal.

2. The permanent office assisting the Provincial-level Board is located at the Provincial Center for Disease Control and uses the Provincial Center for Disease Control's seal.

3. Tasks of the Standing Offices at all levels:

a) Directing and guiding units and individuals to provide relevant files as requested by the Councils at all levels;

b) Allocating legitimate financial resources for the operation of the Councils at all levels;

c) Preparing logistical and administrative activities for the Councils at all levels;

d) The Standing Office at the Ministry level reports to the Minister of Health, the Standing Office at the provincial level reports to the Director of the Provincial Health Department on the results of the meetings;

d) Archive records according to regulations

Article 6. Effectiveness

1. This Circular takes effect from November 15, 2020.

2. Circular No. 24/2018/TT-BYT dated September 18, 2018, issued by the Minister of Health, stipulating the establishment, organization, and operation of the Expert Advisory Board for evaluating adverse events following immunization, becomes ineffective from the date this Circular takes effect.

Article 7. Responsibility for Implementation

The Head of the Ministry's Office, the Director of the Preventive Medicine Department, the Heads of Departments, Bureaus, and General Administrations under the Ministry of Health, the Heads of subordinate agencies and units under the Ministry, the Directors of Health Departments of provinces and centrally-administered cities, and the Heads of healthcare units under various Ministries, sectors, and related units are responsible for implementing this Circular.

In the course of implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to report to the Ministry of Health for consideration and resolution./.