Elsevier

Health Policy

Volume 124, Issue 2, February 2020, Pages 199-204
Health Policy

The controversy on HPV vaccination in Japan: Criticism of the ethical validity of the arguments for the suspension of the proactive recommendation

https://doi.org/10.1016/j.healthpol.2019.12.011 Get rights and content

Highlights

  • Japan suspending the official recommendation of the HPV vaccine for over 6 years.

  • The arguments for the suspension not satisfying the requirements of public health ethics.

  • The recommendation must either be reinstated or the HPV vaccine policy altered.

Abstract

The Human Papillomavirus (HPV) vaccine was integrated into Japan’s national immunization program (NIP) in April 2013. However, numerous instances of serious adverse reactions were widely reported in the media, resulting in the Ministry of Health, Labor, and Welfare (MHLW) suspending the official recommendation of the HPV vaccine on June 14, 2013. Investigating the reported incidents, the Vaccine Adverse Reactions Review Committee (VARRC)—an MHLW advisory committee—found no high-quality evidence supporting a causal relationship between the reported events and the HPV vaccination. However, rather than lifting the suspension, they have opted to maintain a “pseudo informed consent” confirming the perceptions of Japanese citizens regarding the vaccine. Accordingly, there appears to be a fundamental difference in the approach to vaccine policymaking between Japan (MHLW/VARRC) and other countries and the World Health Organization, which base policy decisions on the effectiveness and safety of the vaccine. Consequently, the arguments for the suspension of the HPV vaccine recommendation are not ethically appropriate. Relevant bodies must make a clear decision regarding the HPV vaccine and its status in the NIP: the proactive recommendation must either be reinstated or the HPV vaccine legal framework altered to rely entirely on voluntary individual decisions.

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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