Circular No. 24/2018/TT-BYT stipulates the establishment, organization, and operation of the Expert Advisory Board for evaluating the causes of severe adverse events during vaccine use.

CIRCULAR

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

PURSUANTWHEREAS, Law on PreventionAND CONTROL OF INFECTIOUS DISEASES No.7/QH12 dated November 21 03/200, 2007;WHEREAS, Decree No. 75/2017/NĐ-CP dated June 20, 2017 of the Government stipulating functions; WHEREAS, Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government stipulating immunization activities;

AT THE REQUEST OF THE DIRECTOR OF THE PREVENTIVE MEDICINE DEPARTMENT;Article 1. Amending and supplementing some articles of Circular No. 56/2017/TT-BYT dated December 29, 2017 of the Minister of Health detailing the implementation of the Social Insurance Law and the Labor Safety and Health Law in the field of health (hereinafter referred to as Circular No. 56/2017/TT-BYT);

Based on Decree No. 1ISSUES THIS CIRCULAR TO REGULATE THE ESTABLISHMENT, ORGANIZATION AND OPERATIONS OF THE SPECIALIZED ADVISORY BOARD FOR ASSESSING CAUSES OF SEVERE ADVERSE EVENTS FOLLOWING IMMUNIZATION.

Article 1. Establishment of the Specialized Advisory Board for Assessing Causes of Severe Adverse Events Following Immunization 1. The Minister of Health shall establish the Specialized Advisory Board for Assessing Causes of Severe Adverse Events Following Immunization under the Ministry of Health (hereinafter referred to as the Central Board).

THE MINISTER OF HEALTH 2. The Director of the Department of Health of each province or centrally governed city shall establish the Specialized Advisory Board for Assessing Causes of Severe Adverse Events Following Immunization at provincial level (hereinafter referred to as the Provincial Board).Article 2. Functions, Tasks, Authorities and Composition of Members of the Central Board1. Functions of the Central BoardTo provide specialized advice to the Minister of Health in handling cases of severe adverse events following immunization as prescribed in Article 6 of Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government stipulating immunization activities.

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;

b) To re-evaluate the conclusions of the Provincial Board in cases where organizations or individuals have complaints about the conclusions of the Provincial Board or upon request from competent state authorities.

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;

b) To be guaranteed conditions necessary to perform its tasks.

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;

d) In cases deemed necessary and depending on specific circumstances, the Ministerial-level Council Chairman may invite additional experts in finance, forensic pathology, emergency resuscitation, law, and other relevant fields related to severe adverse events following immunization to join the Council.

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:

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

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

2. Methods of Council operation

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

b) All discussion contents, including opinions not consistent with the Council's conclusion and proposals, must be fully recorded in the Council meeting minutes. The Council meeting minutes of the Central Council must be prepared in two copies, one retained by the Council's permanent unit and one reported to the Ministry's leadership. The Council meeting minutes of the Provincial Council must be prepared in two copies, one retained by the Council's provincial permanent unit and one reported to the Director of the Department of Health.

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).

1. The Standing Committee of the Council at the Ministry level assists the Council at the Ministry level and is located at the Preventive Health Department.

2. The Standing Committee of the Council at the provincial level assists the Council at the provincial level and is located at the Provincial Center for Disease Control.

3. Tasks of the Standing Offices at all levels:

a) Collecting and compiling materials related to severe adverse events following immunization;

b) Preparing the agenda for Council meetings and finalizing the minutes of each meeting;

c) After finalizing the Council meeting minutes, the Standing Committee of the Council at the Ministry level reports to the Minister of Health, and the Standing Committee of the Council at the provincial level reports to the Director of the Provincial Health Service on the results of the meeting;

d) Storing records in accordance with regulations.

Article 6. Effectiveness

1. This Circular takes effect from November 15, 2018.

2. Circular No. 21/2011/TT-BYT dated June 7, 2011, issued by the Minister of Health, regarding the establishment, organization, and operation of the Expert Advisory Council for evaluating adverse events during the use of vaccines and medical products, shall be repealed upon the effective date of this Circular.

Article 7. Responsibility for Implementation

The Head of the Ministry's Office, the Director of the Preventive Health Department, the Heads of Departments, Directors of Bureaus, General Directors under the Ministry of Health, Heads of agencies and units directly under the Ministry, Directors of Provincial Health Services, and Heads of health units under various Ministries, sectors, and relevant units are responsible for implementing this Circular.

In the course of implementation, if there are difficulties or obstacles, they are requested to report to the Ministry of Health for consideration and resolution./.