On November 1, 2025, the Japan Association of New Economy (JANE. Location: Minato-ku, Tokyo; Representative Director: Mickey Mikitani) submitted its comments regarding the Ministry of Health, Labour and Welfare’s “Draft Ministerial Ordinance for the Development of Related Ministerial Ordinances, etc., in conjunction with the enforcement of part of the Act for Partial Revision of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, etc.”

【Summary of Submitted Comments】

1. Overall Comment
   • While measures to prevent the overuse of over-the-counter (OTC) medicines should be advanced as a comprehensive government initiative, not limited to point-of-sale interventions but also including efforts to address loneliness and social isolation and to promote awareness, it is imperative to conduct an objective and scientific review to ascertain the efficacy of the newly proposed regulations governing OTC medicine sales in preventing abuse. Furthermore, if the regulations cannot be confirmed as rational and effective, considering trends in medicine pricing and access for appropriate users, a review of the system should be undertaken.

2. Comments on Each Item
   • Regarding the sales method of “guidance-required pharmaceuticals” through online medication guidance, it is stipulated that such guidance can be provided “when a responsible judgment can be made on each occasion.” However, it should be clarified how responsibility is specifically ensured in both in-person and online medication guidance. Caution should be exercised to avoid imposing disproportionate responsibility solely on qualified professionals in online settings, particularly when the scope of responsibility in in-person settings remains unclear.
   • Regarding the sales methods for Designated Abuse-Prevention Pharmaceuticals, the supplementary resolution to the amended Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, etc. stipulates that regulations should consider diverse sales formats and ensure a balanced approach between preventing abuse and maintaining user convenience, so as not to unduly restrict access to medicines.” However, a survey conducted by an e-commerce platform regarding changes in sales methods for pharmaceuticals with abuse potential revealed that only a very small number of businesses planned to sell designated abuse-prevention pharmaceuticals via video call. The primary reasons cited by businesses not planning to do so were “difficulty in implementing systems” and “sales processes becoming too complex.” A situation where many online pharmaceutical retailers cease sales would impede access for appropriate users. Furthermore, given the lack of rational evidence demonstrating the effectiveness of video calls in preventing abuse, and the absence of facts indicating that text-based online sales promote abuse, sales methods that leverage the characteristics of the internet and do not rely on in-person or video call interactions should be added to the ministerial ordinance as “other” methods.
   • Regarding the regulations concerning the provision of information for designated abuse-prevention pharmaceuticals, the stipulations requiring individual information provision to purchasers are identical to those for Class 1 pharmaceuticals. However, given that Class 1 pharmaceuticals and designated abuse-prevention pharmaceuticals differ in the potential severity of health damage that could impair daily life due to side effects, it is imperative to respect the information provision methods established for each pharmaceutical classification under existing regulations. Furthermore, consideration should be given to convenience, such as access to pharmaceuticals, to ensure that the system does not impede purchases by appropriate users.
   • The confirmation items stipulated in this ordinance for the sale or provision of designated abuse-prevention pharmaceuticals can also be verified through online sales without video calls. Therefore, to enable online sales, sales methods that do not involve in-person or video call interactions should be added to the ministerial ordinance as “other” methods.
   • Regarding the display fixtures for designated abuse-prevention pharmaceuticals and the continuous presence of qualified professionals during in-person sales, it should be verified, using objective data such as the actual channels through which drug abusers obtain these pharmaceuticals, whether the newly introduced measures are effective in preventing abuse. If their effectiveness in preventing abuse is found to be insufficient, these measures should be subject to review and reconsideration.

Please click here for the full text of the submitted comments. (Japanese only)
Please click here for details on this public consultation. (Japanese only)