【日薬連/EFPIA/PhRMA:共同発表】2021年度(令和3年度)薬価改定に関する共同声明/Joint Statement on FY 2021 Drug Price Revision

【日薬連/EFPIA/PhRMA:共同発表】2021年度(令和3年度)薬価改定に関する共同声明/Joint Statement on FY 2021 Drug Price Revision


会長  手代木 功
会長  ハイケ・プリンツ
委員長 クリストファー・フウリガン




Joint Statement on FY 2021 Drug Price Revision

December 18, 2020
Isao Teshirogi
President, The Federation of Pharmaceutical
Manufacturers’ Associations of Japan

Heike Prinz
Chair, European Federation of Pharmaceutical
Industries and Associations of Japan
(EFPIA Japan)

Christopher Hourigan
Chair, Japan-based Executive Committee
Pharmaceutical Research and Manufacturers of America

 The Central Social Insurance Medical Council has recently compiled the Outline of the FY 2021 Drug Price Revision.
 On behalf of the pharmaceutical industry, which aims to realize a society of healthy longevity through the development and stable supply of innovative drugs, we express our views as follows.

 The Basic Policy for Fundamental Reform of the Drug Pricing System (agreed by the four Ministers on December 20, 2016; hereinafter the ‘Basic Policy’) referred to the off-cycle drug price revision in terms of ‘conducting a drug price revision on products with a large price discrepancy’. Subsequently the Basic Policy on Economic and Fiscal Management and Reform 2020 (given Cabinet approval on July 17, 2020; hereinafter ‘2020 Honebuto Policy’) stated that the ‘FY 2021 drug price revision shall be fully reviewed and decided on taking into consideration the impact of the new coronavirus infection (COVID-19) and the content of the 2018 and other Honebuto Policies’.
 With reference to the above background the pharmaceutical industry has held that the scope of the drug price revision should be limited to products of which the discrepancy rate between the NHI price and the market price is significantly greater than the average discrepancy rate of all listed products. However, it has been decided that the FY 2021 drug price revision shall be applied to products with a discrepancy rate of more than 5.0%, which is 0.625 times the average discrepancy rate of 8.0%, and the revision rate shall be relaxed by 0.8% as a “COVID-19 special exception”. This decision deviates significantly from the background to the discussions following the Basic Policy and the intent of the 2020 Honebuto Policy. At the same time it undermines the predictability of Japan’s drug pricing system and is completely unacceptable. In addition, the market pricing status, the management status of medical institutions, pharmacies and drug wholesalers, drug development and stable supply and above all the impact of COVID-19 cannot be described as having been fully taken into consideration. We can only perceive the decision as a significantly unbalanced one in terms of achieving a balance between the ‘reduction of the public burden’ and ‘improving the quality of healthcare’.
 With a view to securing access to innovation in Japan and establishing a drug pricing system that is highly transparent and acceptable to the public and all stakeholders, we, the representatives of the pharmaceutical industry, will continue to participate in drug pricing reform discussions including the modality of the drug price revision.