Originals

Asian Pacific Journal of Disease Management 2020; 9(1·2), 00-00
Copyright© 2013 JSHSS. All rights reserved.

Recent court case recalls the potentiality of internet tools
for e-healthHaruhisa Inaba
Department of Community Preventive Medicine, Graduate School of Medical and Dental Sciences, Niigata
University

OpinionsIntroduction
Case Report
Implications

court found that to compare the risk of pharmaceuticalitems immediately after their classification has beenswitched, a pharmacist must provide required information or guidance to purchasers at the pharmacy; therefore, FOTC regulation was reasonable3).

Introduction

Implications

The Ministry of Health, Labour and Welfare(MHLW), under the amended Pharmaceutical Affairs
Act and Pharmacists Act (currently called “The Law on
Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices”; hereinafter called “the Law”) of 2014, categorized new
items immediately after their switch to OTC pharmaceuticals as face-to-face sold OTC (FOTC) pharmaceuticals1). Consequently, the internet sales of FOTC pharmaceuticals have been forbidden for a defined period2).
X, an online shopping company, filed a lawsuit against
the MHLW stating that the ban on freedom of occupation by the Law is unconstitutional3).

Technological innovation in information and communications has changed distribution methods of
non-prescription drugs4). Amid the continuous rise of
medical cost for the public, the trend of self-medication
using non-prescription drug may further expand in thefuture. On the other hand, it is required to pay sufficientattention to adverse effects. Problems are not solved byregulating face-to-face or internet sale alone. In consideration of advantages in each selling method, it shouldbe prioritized to establish a trusty relationship between
various methods by admitting advantages each otherand to improve hospitality. First, we believe that it isimportant to safely and easily distribute pharmaceuticals to individuals who really need them. Second, pharmacy education should introduce a curriculum on thesafe online pharmaceutical sale-related issues, expanding the range of activities for pharmacists. Lastly, it isnecessary to establish methods to track the adverse effects in patients who purchased pharmaceuticals online
without adding restrictive measures. To promote
self-medication5), it is important to share necessary information with the parties involved.

Case Report
On July 18, 2017, the Tokyo District Court dismissed X’s assertion3). The case became the first judicial decision against the FOTC regulation. Plaintiff X
alleged that the risk cannot be prevented by providing
information, regardless of the sales method used3). The
defendants claimed that face-to-face sales were moresuitable than internet sales for pharmacists providing
information and guidance, the object and period to beregulated as FOTC pharmaceuticals were limited. The
Received: July 3, 2018
Accepted: July 17, 2018757 Ichibancho, Asahimachi-dori, Chuo Ward, Niigata City,Niigata 951-8510, Japan
Tel: +81-25-227-2146; Fax: +81-25-229-5184;
e-mail: hinaba-nii@umin.ac.jp

CW6_A3238D02.indd

1References
1) The Law on Securing Quality, Efficacy and Safetyof Products Including Pharmaceuticals and Medical devices; Article4(5)(ⅲ). http://www.japanese​
lawtranslation.go.jp/law/detail/?id=3213&vm=04&re=01&new=1, (Accessed March 1, 2018)
2) The Ministry of Health, Labour and Welfare: Annual Health, Labour and Welfare Report 2013-2020/04/21

16:51:13

2

Asian Pacific Journal of Disease Management 2020; 9(1·2), 00-00

2014: 275. http://www.mhlw.go.jp/english/wp/wphw8/dl/appendix.pdf, (Accessed March 1, 2018)3) Westlaw Japan 2017WLJPCA07186001. (In Japanese) (Accessed March 1, 2018)4) Cicero, Theodore J: Health outcomes in patientsusing no-prescription online pharmacies to pur-chase prescription drugs. J Med Internet Res 14(6),e174 (2012). doi: 10.2196/jmir.2236.
5) WHO: The Role of the Pharmacist in Self-Care andSelf-Medication. https://apps.who.int/iris/bitstream/
handle/10665/65860/WHO_DAP_98.13.pdf?se​quence=1&isAllowed=y, (Accessed March 1, 2018)

Copyright© 2013 JSHSS. All rights reserved.

CW6_A3238D02.indd2

2020/04/21

16:51:13