Recently, the supply and demand of essential vaccination vaccines required for national vaccination programs, such as for tuberculosis (intradermal BCG) and polio (IPV), remains unstable, causing public unrest.

There must be various causes behind this problem; first and foremost, however, it is necessary to secure enough vaccines produced from abroad, which cannot be produced directly in Korea.

Accordingly, the Amendment aims to provide a legal basis for the Nation to make a long-term contract with a vaccine manufacturer, etc., thereby providing more incentives to supply enough vaccines in Korea; and to encourage the accumulation of vaccines at an appropriate quantity, thereby addressing unstable supply and demand of vaccines.

Along with these, the relevant authority shall understand the accurate status of production, import, etc., but there is not enough information to identify them. Therefore, the amendment aims to require the Minister of Health and Welfare to timely identify the supply and demand thereof and take necessary measures, by imposing manufacturers and importers of vaccines the obligation to regularly report the information to the Minister of Health and Welfare about production and importation to make him/she understand accurately the status of domestic vaccine supply and demand.

 Details

A. To ensure that the essential vaccinations and special vaccination services are performed smoothly, the necessary vaccines shall be stockpiled in advance through deliberations by the Infectious Disease Control Committee, or contracts for long-term purchase may be made in advance; and the matters related to the distribution criteria, etc. such as the priority of the supply of stockpiled vaccines shall be determined through considerations by the Infectious Disease Control Committee (Article 33-2 newly inserted)

B. A manufacturer, a contract manufacturer, or an importer who obtained a marketing approval or filed a marketing notification pursuant to the Pharmaceutical Affairs Act shall report to the Minister of Health and Welfare the plans and results of the production and importation of vaccines necessary for essential vaccinations and special vaccination services (Article 33-3 newly inserted)

A person who obtained a marketing approval or filed marketing notification, pursuant to Article 31 and Article 42 of the Pharmaceutical Affairs Act, shall report the plans and results of the production and importation of essential vaccinations, etc., as prescribed by Ordinance of the Ministry of Health and Welfare (Article 33-3).