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Japan: Three Vaccinations Added to Routine Vaccination Schedules

(Apr. 9, 2013) The recent amendment to <?Japan's Vaccination Law added haemophilus influenzae type B (Hib), human papilloma virus (HPV), and pediatric streptococcus pneumoniae to the routine vaccination schedule. (Act No. 8 of 2013 (Mar. 30, 2013), amending the Vaccination Law, Act No. 69 of 1976.) The Law obligates municipalities to provide specified age groups of residents with vaccines listed on the routine schedule. These qualified residents do not have to pay anyfees. (Vaccination Law, art. 3.) Residents can take other vaccines on a voluntary basis, paying the fees themselves.

The amendment also added a provision concerning a reporting system for incidents of side effects of vaccines. (Id. art. 12.) Before the amendment, side effects of vaccines were reported by medical doctors to local health centers based on the provisions of a Ministry of Health, Labor and Welfare (MHLW) circular. (Yobo_ sesshu jisshi yoryo_ [Vaccination Manual], MHLW Circular, Health No. 0127005 (Jan. 27, 2005), ยง 20.) In addition, the incidents of vaccine side effects were reported by medical doctors, hospitals, and pharmacies to the MHLW under the Pharmaceutical Affairs Law (Act No. 145 of 1960, last amended by Act No. 105 of 2011, art. 77-4-2).

The new reporting system under the Vaccination Law is integrated with a similar system under the Pharmaceutical Affairs Law; therefore, one report, as provided for under the Vaccination Law, satisfies the original dual reporting obligations, under each of the two laws. (Yobo_ sesshu go fuku hann_ ho_koku no seido ga kawari masu [Reporting System of Cases of Vaccine Side Effects Changes], Akita Prefecture (Apr. 1, 2013) .) The report under the Pharmaceutical Affairs Law is no longer required anymore, but the relevant provision has not been changed.