Vaccines

1. 1. Basic Policy on the Comprehensive and Systematic Promotion of Measures Related to Immunization
   2. Matters related to the division of roles related to vaccination among the national government, local governments, and other related parties
   3. Goals related to the comprehensive and systematic promotion of vaccination measures
   4. Basic Matters for Promoting Measures for the Proper Implementation of Vaccination
   5. Basic matters for promoting measures to promote research and development of vaccination and securing the supply of vaccines
   6. Basic Matters for Promoting Measures to Improve the Effectiveness and Safety of Vaccination
   7. Matters Concerning International Cooperation on Immunization
   8. Other important matters related to the comprehensive and systematic promotion of vaccination measures

Though it states that “This plan will be reviewed at least every five years in accordance with the Immunization Act, and will be changed when deemed necessary,” it has never been revised due to the pandemic of the COVID-19 and other reasons.

The EFPIA Japan Vaccine Working Team (VWT), in collaboration with three other vaccine-related Trade Associations (Japan Association of Vaccine Industries: JAVI, Japan Pharmaceutical Manufacturers Association: JPMA and Pharmaceutical Research and Manufacturers of America : PhRMA; collectively “4 Dantai”), made “Recommendations on the development of a promotion system from vaccine research and development to practical application and routine vaccination based on the Basic Strategy for Infectious Disease Prevention (excluding those related to the Pharmaceuticals and Medical Devices Act).” In August 2022, we submitted a request to the Immunization Office, MHLW.

Taking this opportunity, discussions between the Immunization Office and 4 Dantai were started to review the basic plan, and following points: “Incentivize the vaccines with high development priority,” “Digitization of vaccination history,” “Comprehensive and systematic promotion of measures related to vaccination,” and “Review of the overall system for the purpose of life course immunization.” 4 Dantai including the EFPIA Japan VWT, made statements on these four points at the 32nd meeting of the Immunization and Vaccine Subcommittee of the Health Science Council held on May 24, 2023.

Also at the same time, to simplify the national test of vaccines, we are proceeding with discussions between 4 Dantai, including the EFPIA Japan VWT, and the Pharmaceuticals and Pharmacies Division of MHLW. One of the issues is the speeding up and simplification of national test using the Summary Lot Protocol (SLP), which is strongly promoted through industry-government collaboration, and regular discussions are being held for the revision of the law. EFPIA aims to realize this by strengthening its efforts to reach out to national stakeholders and relevant authorities in collaboration with other organizations.

Furthermore, various modalities, including monoclonal antibody, have been developed to prevent infectious diseases in addition to vaccines, and antibody drugs for the prevention of RSV infection are already being used as NIP (National Immunization Program) in developed countries around the world. In terms of Japan’s immunization policy, the EFPIA Japan VWT is advocating for those involved in policymaking while hearing to the opinions of legal experts to determine whether or not these are included in the “vaccines” under the Immunization Act.

Based on these findings, a revised draft of the “Basic Plan on Immunization” was released at the 66th meeting of the Immunization and Vaccine Subcommittee of the Health Science Council held on December 26, 2024, and many of the requests of the 4 Dantai, including the EFPIA Japan VWT, were incorporated into the changes, including the above, and will be notified by the end of this fiscal year pending final deliberations.

In the current revision of the basic plan for immunization, discussions were held while institutional studies related to NIP category A and B, which require revision of the Immunization Act, have not been started, so the EFPIA Japan VWT will play a central role in making requests, including a large-scale review of the Immunization Act, in cooperation with three other vaccine-related organizations.