Circular No. 21/2011/TT-BYT stipulates the establishment, organization, and operation of the Expert Advisory Board for evaluating adverse events during the use of vaccines and medical products.

CIRCULAR

Regulations on the establishment, organization, and operation of the Expert Advisory Council for evaluating adverse events during vaccine and medical product use

đánh giá tai biến trong quá trình sử dụng vaccine, sinh phẩm y tế

Pursuant to the Law on Prevention and Control of Infectious Diseases No. 03/2007/QH12 dated November 21, 2007;
Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;
The Ministry of Health stipulates the establishment, organization, and operation of the Expert Advisory Council for evaluating adverse events during vaccine and medical product use (hereinafter referred to as the Council) as follows:

I. ESTABLISHMENT OF THE COUNCIL

1. The Council of the Ministry of Health (hereinafter referred to as the Council at the Ministerial level) shall be established by the Minister of Health and shall consist of the following components:

a) Chairman of the Council at the Ministerial level: Director of the Preventive Medicine Department;

b) Two Vice Chairmen of the Council at the Ministerial level include:

- Leadership of the Central Institute of Hygiene and Epidemiology;

- Deputy Director of the Preventive Medicine Department.

c) Members of the Council at the Ministerial level:

- Leadership of the Drug Administration Department;

- Leadership of the Science and Training Department;

- Leadership of the Medical Examination and Treatment Management Department;

- Leadership of the Inspectorate;

- Leadership of the Legal Affairs Department;

- Leadership of the International Cooperation Department;

- Leadership of the National Tropical Diseases Hospital;

- Leadership of the National Children's Hospital;

- Leadership of the National Obstetrics and Gynecology Hospital;

- Leadership of the Central Institute of Hygiene and Epidemiology;

- Leadership of the West Central Hygiene and Epidemiology Institute;

- Leadership of the Ho Chi Minh City Pasteur Institute;

- Leadership of the Nha Trang Pasteur Institute;

- Leadership of the National Institute for Vaccine and Biomedical Product Control;

d) The Secretariat assisting the Council at the Ministerial level shall be designated by the Chairman of the Council at the Ministerial level;

đ) The Standing Body of the Council at the Ministerial level shall be located at the Preventive Medicine Department.

e) In addition to the components specified in this clause, when necessary and depending on specific circumstances, the Chairman of the Council at the Ministerial level may invite additional experts from relevant fields related to post-vaccination adverse events.

2. The Council of provinces and centrally-administered cities (hereinafter referred to as the Council at the provincial level) shall be established by the Provincial Health Department Director and shall consist of the following components:

a) Chairman of the Council at the provincial level: Representative of the Provincial Health Department Leadership;

b) Vice Chairman of the Council at the provincial level: Director of the Provincial Preventive Medicine Center;

c) Members of the Council at the provincial level:

- Leadership of the Health Services Department, Provincial Health Department;

- Leadership of the Infectious Disease Control and Vaccination Department, Provincial Preventive Medicine Center;

- Leadership of the Provincial General Hospital;

- Leadership of the Provincial Health Department Inspectorate;

- Leadership of the Pharmaceutical Services Department, Provincial Health Department;

- Leadership of the Forensic Medical Center or forensic department within the Provincial General Hospital;

- Representative of one of the following Institutes: Central Institute of Hygiene and Epidemiology (for provinces and cities in the Northern region); Nha Trang Pasteur Institute (for provinces and cities in the Central region); West Central Hygiene and Epidemiology Institute (for provinces and cities in the Central Highlands region); Ho Chi Minh City Pasteur Institute (for provinces and cities in the Southern region);

- Representative of the unit involved in treating patients.

d) The Secretariat assisting the Council at the provincial level shall be designated by the Chairman of the Council;

đ) The Standing Body of the Council at the provincial level shall be located at the Provincial Preventive Medicine Center;

e) In addition to the components specified in this clause, when necessary and depending on specific circumstances, the Chairman of the Council at the provincial level may invite additional experts from relevant fields related to post-vaccination adverse events.

3. Individuals engaged in vaccination work shall not participate in the composition of the Council.

II. FUNCTIONS AND TASKS OF THE COUNCIL

1. Functions of the Council:

Providing expert advice to the Minister of Health or the Provincial Health Department Director regarding the resolution of post-vaccination adverse events that significantly affect the health or life of the vaccinated individual within their jurisdiction.

2. Tasks of the Council and its Standing Body:

a) Task of the Council at the Ministerial level: Re-evaluating the results of the evaluation by the Council at the provincial level concerning the causes of post-vaccination adverse events nationwide based on the proposal of the Standing Body of the Council at the Ministerial level.

b) Task of the Council at the provincial level: Organizing investigations and evaluating the causes of all post-vaccination adverse events within their jurisdiction based on the proposal of the Standing Body of the Council;

c) Task of the Standing Body of the Council at the Ministerial level:

- Receiving and compiling reports from the Chairman of the Council regarding the evaluation by the Council at the provincial level concerning the causes of post-vaccination adverse events;

- Proposing a meeting of the Council at the Ministerial level to re-examine the results of the evaluation by the Council at the provincial level if necessary;

- Reporting to the Head of the Emergency Response Steering Committee, the Minister of Health, and relevant units about measures to address post-vaccination adverse events after the conclusion of the Council at the Ministerial level.

d) Task of the Standing Body of the Council at the provincial level:

- Collecting and compiling materials related to post-vaccination adverse events within their jurisdiction;

- Proposing the organization of investigations and evaluations of the causes of all post-vaccination adverse events within 24 hours of receiving information about post-vaccination reactions;

- Reporting to the Standing Body of the Council at the Ministerial level and relevant provincial authorities about measures to address post-vaccination adverse events after the conclusion of the Council at the provincial level.

III. REGULATIONS ON THE OPERATIONS OF THE COUNCIL

1. The Council shall convene only when at least two-thirds of its members are present.

2. The Council operates under a collective system, deciding by majority vote. In case of disagreement among members, the Chairman will make the final decision.

3. All discussion contents, including dissenting opinions with the Council's conclusions and recommendations, must be fully recorded in the Council's minutes.

4. The Council at each level shall meet twice a year, mid-year and end-of-year, to review and draw lessons. The Council at each level shall convene extraordinary meetings upon request of the Standing Body of the Council when there are issues requiring resolution.

5. Announcements regarding the investigation and evaluation of vaccine and medical product use shall be made in accordance with the law on public statements and information provision to the press.

6. During the process of investigating the cause, the Council may seek opinions from relevant organizations, units, and individuals to obtain additional information and scientific basis for concluding the cause.

7. The permanent unit of the Council is responsible for establishing regulations on the working procedures of the Council to be submitted to the Chairman of the Council for approval and issuance.

8. The operating funds of the Council are allocated within the annual state budget estimate for health services and other state budgets (if any).

IV. EFFECTIVE DATE OF IMPLEMENTATION

This Circular takes effect from September 1, 2011.

Point a Clause 2 Article 19 of Decision No. 23/2008/QĐ-BYT dated July 7, 2008 of the Minister of Health on the regulations for the use of vaccines and medical products in prevention and treatment shall cease to be effective from the date this Circular takes effect.

Any difficulties or obstacles encountered during implementation should be reported to the Ministry of Health (Preventive Medicine Department) for consideration and resolution./.