Three Pharmaceutical Organizations of Japan, the U.S., and Europe: Joint Statement on the Fiscal 2023 NHI Drug Price Revision

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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 compiled the "Framework for the Fiscal 2023 NHI Drug Price Revision" (hereinafter referred to as the "Framework").

The following is a summary of our

comments

.

　The three pharmaceutical organizations of Japan, the U.S., and Europe have argued that the 2023 midyear NHI price revision is not in a position to be implemented, given the fact that the effects of the five consecutive years of NHI price revisions since 2018 have begun to appear in various parts of the country. In addition, the organizations have also requested that new drugs that are still under patent protection be excluded from the mid-year revision, given that maintaining drug prices during the patent period is the standard in major developed countries and that access to new drugs may be further impaired due to the declining attractiveness of the Japanese market.

　However, in the recent NHI price revision for FY2023, following the previous mid-year revision, items exceeding 0.625 times the average deviation rate of 7.0% (deviation rate of 4.375%) are now subject to revision. It is truly regrettable that the decision to implement NHI drug price revisions for such a wide range of items was made despite the fact that various problems directly affecting the lives of the Japanese people have become apparent underfoot in terms of access to and stable supply of innovative drugs.

　We recognize that a certain degree of consideration has been given to the addition of a special exception to the additional payment for new drug creation, which eases the reduction of NHI drug prices for certain new drugs, in light of the pharmaceutical industry's past advocacy of the evaluation and promotion of innovation.

　In order to ensure the early and reliable introduction of innovative new drugs into Japan, the current revisions based on prevailing market prices need to be fundamentally revised, along with appropriate evaluation of innovation and a mechanism to maintain drug prices during the patent period. As indicated in the "Framework," we strongly hope that the NHI will actively consider this issue in the discussions on the reform of the NHI drug pricing system in 2024, based on the discussions at the "Expert Panel on Comprehensive Measures to Achieve a Prompt and Stable Supply of Pharmaceuticals".

　We, the pharmaceutical industry, will continue to actively participate in the discussions on the future reform of the NHI drug price system, including the NHI price revision, in order to establish a drug price system that ensures access to innovation in Japan and is transparent and convincing to all stakeholders, including the public.

Thank you for your continued

support

.

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