Joint Statement by Three Pharmaceutical Associations from Japan, the U.S., and Europe: Regarding the FY2023 (Reiwa 5) Drug Price Revision
December 21, 2022
Japan Pharmaceutical Manufacturers Association (JPMA)
Pharmaceutical Research and Manufacturers of America (PhRMA)
European Federation of Pharmaceutical Industries and Associations (EFPIA Japan)
The Central Social Insurance Medical Council has recently finalized the “Outline of the Reiwa 5 Drug Price Revision” (hereinafter referred to as the “Outline”).
From the perspective of the pharmaceutical industry, which aims to realize a society of healthy longevity through the research, development, and stable supply of innovative medicines, we hereby express our views as follows.
Details
To date, the three pharmaceutical associations from Japan, the U.S., and Europe have argued that conditions do not warrant implementing the FY2023 interim drug price revision, given that the effects of five consecutive years of drug price revisions since 2018 are beginning to be felt in various sectors.Furthermore, given that maintaining drug prices during the patent term is standard practice in major developed countries, and considering the current situation where the declining attractiveness of the Japanese market risks further impairing access to new drugs, we have called for new drugs under patent protection to be excluded from the mid-year price revision.
However, in the FY2023 drug price revision, following the precedent set by the previous mid-year revision, products with an average deviation rate exceeding 0.625 times the 7.0% average deviation rate (a deviation rate of 4.375%) were designated as subject to revision.It is truly regrettable that the decision was made to implement drug price revisions affecting such a broad range of products, despite the fact that various issues directly impacting the lives of the public regarding access to and the stable supply of innovative pharmaceuticals are becoming apparent right before our eyes.
Regarding the addition of a special application of the “New Drug Creation, etc. Surcharge,” which moderates price reductions for certain new drugs, we recognize that a certain degree of consideration has been given, in light of the pharmaceutical industry’s long-standing advocacy for the evaluation and promotion of innovation.
To ensure that innovative new drugs can continue to be introduced to Japan promptly and reliably, a fundamental review of the current system of price revisions based on prevailing market prices is necessary, in conjunction with mechanisms for the appropriate evaluation of innovation and the maintenance of drug prices during the patent term.As indicated in the “Outline,” and based on the discussions held by the “Expert Panel on Comprehensive Measures for the Rapid and Stable Supply of Pharmaceuticals,” we strongly hope that these issues will be actively considered during the discussions on the FY2024 drug pricing system reform.
We in the pharmaceutical industry will continue to actively participate in discussions regarding future drug pricing system reforms—including the approach to drug price revisions—with the aim of ensuring access to innovation in Japan and establishing a drug pricing system that offers high levels of transparency and is widely accepted by the public and all stakeholders.
Reference Materials
Contact Information
Public Relations Department, Japan Pharmaceutical Manufacturers Association (JPMA)
- Phone
- 03-3241-0374
- Contact Form
- www.jpma.or.jp/inquiry/
Pharmaceutical Research and Manufacturers of America (PhRMA) Public Relations Office (c/o Japan Counselors, Inc.)
- Phone
- 03-3291-0118
European Federation of Pharmaceutical Industries and Associations (EFPIA Japan) Public Affairs Committee Yuko Kidoguchi, Bayer Holding K.K.
- Phone
- 03-6266-7757