2025.12.16

【Public Consultation】Submission of Comments on the “Draft Pharmaceuticals designated by the Minister of MHLW based pursuant to Article 36-11, Paragraph 1 of the PMD Act and the “Draft Quantities determined by Minister of MHLW pursuant to Article 159-18-6, Paragraph 1 of the Ordinance for Enforcement of the PMD Act by the MHLW

Policy Advocacy Advocacy
 
On December 12, 2025, the Japan Association of New Economy (JANE. Location: Minato-ku, Tokyo; Representative Director: Mickey Mikitani) submitted its comments regarding the “Draft Pharmaceuticals designated by the Minister of Health, Labour and Welfare pursuant to Article 36-11, Paragraph 1 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (hereinafter referred to as the “PMD Act”) (the Draft is hereinafter referred to as the “Designation Notice for Designated Abuse-Prevention Pharmaceuticals”) and the “Draft Quantities determined by the Minister of Health, Labour and Welfare pursuant to Article 159-18-6, Paragraph 1 of the Ordinance for Enforcement of the PMD Act” (the Draft is hereinafter referred to as the “Quantity Notice for Designated Abuse-Prevention Pharmaceuticals “), for which the Ministry of Health, Labour and Welfare (MHLW) invited public consultation.
 
【Summary of Comments】
1. General Comments
 
· While measures to prevent the overdose of over-the-counter (OTC) drugs are intended to be pursued as a government-wide initiative—including measures against loneliness and isolation, as well as public awareness, rather than just point-of-sale responses—the effectiveness of the current regulation, which limits purchasing methods to face-to-face interactions, should be examined based on objective and scientific evidence.
 
· Furthermore, taking into account the trends in pharmaceutical prices and the perspective of access to medicines for appropriate users, the system should be reviewed if the regulations cannot be confirmed as rational and effective.
 
2. Comments on Each Notice

1) Designation Notice for Designated Abuse-Prevention Pharmaceuticals
· Since this system revision significantly hinders access to medicines for appropriate users, the existing online sales should be continued, taking into account the balance between abuse prevention and convenience.
 
· Furthermore, as the pharmaceuticals subject to the revision include many products used in daily life—such as cold medicines and anti-allergy drugs—as well as items like medicated drops (candy) that are practically difficult to consume in excessive quantities, the system should not be uniformly regulated based solely on ingredients. Instead, it should be designed with consideration for the balance between abuse prevention and convenience, while also taking into account the actual status of abuse.
 
· This system revision will increase the number of pharmaceuticals subject to regulation compared to the existing system. However, the newly targeted pharmaceuticals include items such as “Medicon,” which have been used as OTC substitutes due to supply shortages of prescription-only medicines. While the abuse of OTC drugs itself is a significant social issue, the system should be designed to balance between abuse prevention and convenience, ensuring that appropriate users can continue to obtain the necessary amount of medicines as they have done until now, even as countermeasures are implemented.
 
2) Quantity Notice for Designated Abuse-Prevention Pharmaceuticals
· OTC drugs function as “household medicines,” purchased in advance of symptoms or to prepare for when symptoms arise for oneself and one’s family. However, the method of uniformly regulating the quantity per purchase and prohibiting online sales when that quantity is exceeded lacks the perspectives of both promoting self-medication and ensuring access to medicines. Furthermore, the current regulation focuses solely on the quantity per purchase. It does not establish criteria for judgment from the perspective of abuse prevention—such as identifying what quantity purchased over what period should warrant caution through the management of medication history—nor does it develop the environment to enable such judgment. Consequently, it may fail to function as an effective abuse prevention measure and could simply raise the purchase hurdle for all users, regardless of whether they are appropriate or inappropriate users.
 
· If even those aged 18 and older are restricted from purchasing OTC drugs online as they currently do—limited to a maximum of 5 days’ supply per transaction (or 7 days for cold medicines, rhinitis medications, or antipyretics)—it will significantly hinder access for appropriate users, such as by making it impossible to purchase medications for family members. Therefore, at the very least, the standard should be uniformly set to 7 days.
 
· Since the dosage per day for some pharmaceuticals varies depending on the user’s age and other factors, the definition of a “one-day quantity” should be clarified. Based on this clarification, the system should be designed to avoid excessive regulation and ensure that it is easily understandable for the public.
 
Please click here for the full text of the submitted comments. (Japanese only)
Please click the following links on the public consultation documents.
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