Japan’s modern government vaccination programme started after World War II. The programme was initially compulsory, and avoiding vaccinations without justifiable reason was subject to penalties. However, as infectious diseases decreased over time, vaccinations came to be viewed as less important, while their side effects were increasingly considered as social problems. As a result, in 1994, the legal obligation to have any vaccination was abandoned, and the Immunisation Act now only requires individuals to make efforts to have vaccinations that are designated by the Immunisation Act and relevant rules and orders.
The Japanese vaccination system is administrated by the MHLW. (However, the register of vaccinations administered is maintained by local governments, which are generally required to keep such records for five years.) In 2013, the Immunisation Act was reviewed and amended (the 2013 Amendment) in response to the swine flu pandemic in 2011. Two of the main purposes of the 2013 Amendment are to give flexibility to the government vaccination programme by allowing the Minister of the MHLW to formulate a Preventative Vaccination Basic Plan and to review it every five years; and to resolve the ‘vaccination gap’ problem, where the number of vaccines supported by the Japanese government is lower than in other developed countries by adding haemophilus influenza type b, pneumococcal and HPV to the government vaccination programme.
The government vaccination programmes
The diseases targeted by the government vaccination programmes are classified into two groups: Category A and Category B.
Category A diseases are defined as ‘diseases which should be included in the vaccination programme in order to prevent their occurrence and transmission, taking into consideration (i) their capability of being transmitted from one person to another; and (ii) their severity or potential severity’, and include the following diseases: diphtheria, pertussis, polio, tetanus, measles, rubella, Japanese encephalitis, BCG, haemophilus influenza type b, pneumococcal, HPV and smallpox.
Category B diseases are defined as ‘diseases which should be included in the vaccination programme in order to prevent individual pathogenesis or severe symptoms, as this will prevent the transmission of such diseases’, and include influenza.
The government vaccination programme involves two types of vaccinations: routine vaccination and temporary vaccination. In addition, there is also voluntary vaccination, which exists outside of the government vaccination programmes in terms of funding.
Routine vaccination is carried out on a routine basis against predetermined individuals who may be affected by the relevant Category A or Category B disease (excluding smallpox). The individuals that are subject to routine vaccination and the date or period for being vaccinated are preliminary determined by the governors of the local government. If such governors recommend individuals to receive a routine vaccination, such individuals or their guardians should make reasonable efforts to have the vaccination administered. However, it is not mandatory to receive a routine vaccination.
If the governors of the local governments find that there is an urgent necessity for vaccinations to prevent the transmission of a Category A or Category B disease, they may recommend designated individuals to receive temporary vaccinations at a designated time or period. If such a recommendation is made, the designated individuals or their guardians should make reasonable efforts to have the vaccination administered. However, it is not mandatory to receive a temporary vaccination.
Individuals can voluntarily receive vaccinations for diseases that are not listed as Category A and Category B diseases, provided they must bear all expenses. Further, vaccinations for Category A and Category B diseases that are received outside the designated date or period are considered to be voluntary vaccinations and the recipients of such vaccinations must bear all expenses.
Costs for vaccinations
Most of the costs for routine and temporary vaccinations are covered by public financial support, and some local governments even provide them for free. However, the costs for voluntary vaccinations must be fully borne by recipients.
Under the Act, it is provided that if any damage to health is caused by routine or temporary vaccinations, the governors of local governments shall provide relief measures. With respect to voluntary vaccinations, individuals may receive relief through the relief system provided by the PMDA for injuries to health caused by pharmaceutical products with adverse effects.
All medical agencies that provide routine and temporary vaccinations, individuals that receive vaccinations and their guardians shall report any damage to health caused by routine or temporary vaccinations (or both) to the MHLW.
If the MHLW receives such a report, it may ask the PMDA to investigate the case. Based on the investigation results of the PMDA, the MHLW, in close cooperation with the National Institute of Infectious Diseases, will organise all information concerning the adverse effects of the vaccination, report such information to each local government and recommend necessary measures to be taken to prevent the adverse effects.
WHO targets for vaccination
As of 1 August 2013, the WHO recommends routine vaccinations against the following diseases: BCG, hepatitis B, polio, DTP, haemophilus influenza type b, pneumococcal, rotavirus, measles, rubella and HPV.
The 2013 Amendment to the Act added haemophilus influenza type b, pneumococcal and HPV to the list of Category A diseases as of April 2013, and, as a result, the government vaccination programmes now cover all the routine vaccinations recommended by the WHO, except for hepatitis B and rotavirus vaccinations.
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