2025.05.15

A Statement from JANE Representative Director Mickey Mikitani on the Enactment of the Bill for Partial Amendment to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices

Japan Association of New Economy (JANE. Location: Minato-ku, Tokyo; Representative Director: Mickey Mikitani) issues the following statement regarding the enactment, on May 15, 2025, of the Bill for Partial Amendment to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
 
1. JANE has consistently advocated that regulations should balance abuse prevention with access and convenience. Specifically, we support:
· Withdrawal of the Ministry of Health, Labour and Welfare’s proposal to mandate video calls for online sales of Over the Counter (OTC) medicines.
· Continuation of existing online sales provided proper record management is maintained.
 
2. Upon passing the bill, the Committee on Health, Labour and Welfare of the House of Councillors adopted supplementary resolutions regarding the sales regulation of designated abuse-prevention pharmaceuticals, including: 
• To ensure that access to pharmaceuticals is not unduly restricted, regulations should take into account diverse sales channels and strike a balance between preventing abuse and maintaining convenience.
• In light of the fact that pharmacies and other retailers engaged in the sale of pharmaceuticals prior to this amendment have played a role in promoting citizens’ self-medication, regulatory measures should be kept to the minimum necessary and remain reasonable so as not to hinder their operations.
 
In view of these resolutions, JANE will continue to urge that subordinate legislations and related rules be established to ensure effective abuse prevention, while leveraging the characteristics of both physical and online sales.
 
3. The abuse of OTC medicines remains a serious social issue. JANE has proposed measures to prevent such abuse in online sales and will remain committed to fostering discussions on these countermeasures and actively promoting awareness-raising activities.
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