The controversy on HPV vaccination in Japan: Criticism of the ethical validity of the arguments for the suspension of the proactive recommendation
Section snippets
The HPV vaccination controversy in Japan
The controversy over the Human Papillomavirus (HPV) vaccine in Japan is well-known both domestically and abroad. The HPV vaccination was integrated into the national immunization program (NIP) in April 2013, but numerous and widespread reports of serious adverse events started to circulate in the media, prompting the suspension of “the proactive recommendation” only two months later. The suspension of the proactive recommendation was still in effect at the time of writing in November 2019, with
The vaccine system in Japan
It is worth exploring the NIP system in Japan to understand what the suspension of a proactive recommendation actually means. Following the revision of the immunization law in April 2013, the NIP was categorized into Routine A and Routine B (Table 1) [10]. Routine A includes vaccines for the collective prevention of both serious communicable diseases and those with a high possibility of outbreak. Whereas these vaccines are not mandatory, citizens are strongly encouraged to try to receive them,
The ethical validity of the VARRC’s deliberation. Ethical considerations required for the vaccine policy
Providing the framework of ethical discussions on public health measures—including the NIP—the “five justificatory conditions” developed by Childress et al. are well-known [31], as are the seven principles developed by Verweij and Dawson in regard to the ethical frameworks governing vaccine policy [32]. Broadly speaking, both frameworks emphasize that decision-making should be based on sufficient evidence of effectiveness and safety, the optimal balance of benefits and risks in public health
Conclusions
This article showed that the ethical problems of the VARRC’s deliberation are largely due to the MHLW/VARRC having renounced its responsibility to determine the policy in its capacity as a public health authority. Indeed, a history of legal battles has contributed to a “reduction of public responsibility” in Japan. The government lost several important litigation cases related to the damaging consequences of the side effects of immunization in the 1990s, making it extremely sensitive to the
Declaration of Competing Interest
None.
Acknowledgements
We gratefully acknowledge Prof. Yasuharu Hidaka (Takarazuka University) for his advice and Editage (www.editage.jp ) for English language editing.
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