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

February 13, 2025
Japan Association of New Economy (JANE)
Representative Director
Mickey Mikitani

The Japan Association of New Economy (JANE. Location: Minato-ku, Tokyo; Representative Director: Mickey Mikitani) issues the statements from its representative director regarding the “Cabinet Decision (February 12, 2025) and submission to the Diet 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 for the withdrawal of the Ministry of Health, Labour and Welfare’s proposal to mandate video calls for online sales of over-the-counter (OTC) medicines with potential abuse risk, instead urging the continuation of existing online sales with proper record management. While ensuring proper use of medicines and smooth consumer access, we will continue to strongly urge that these proposals be reflected in the upcoming law amendments, their subordinate legislations, and related rules under the new framework, thereby achieving the objectives of preventing abuse.

2. Regulations should not be formally identical for physical and online environments. Rather, frameworks should be tailored to each’s unique characteristics, maximizing their respective strengths while ensuring effective measures against abuse. Ensuring the implementation and operation of such measures in both settings is crucial. This approach is essential for users and to secure appropriate access to medicines.

3. The abuse of OTC medicines is a serious social issue. As a business association, we have already proposed countermeasures to prevent abuse in online sales, and we will continue to deepen discussions on these measures while actively promoting awareness-raising initiatives.

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