Joint Statement by Three Pharmaceutical Associations from Japan, the U.S., and Europe:
Joint Statement on the FY2024 (Reiwa 6) Drug Pricing System Reform and Cost-Effectiveness Evaluation System Reform

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December 20, 2023
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 (CSIMC) has recently finalized the “Outline of the Reiwa 6 Drug Price System Reform” (hereinafter referred to as the “Drug Price System Reform Outline”) and the “Outline of the Reiwa 6 Cost-Effectiveness Evaluation System Reform” (hereinafter referred to as the “Cost-Effectiveness Evaluation System Reform 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 new drugs, we hereby express our views as follows.

Details

: To date, the three pharmaceutical associations from Japan, the U.S., and Europe have adhered to the basic policy of “balancing the promotion of innovation with the sustainability of universal health insurance, while improving patients’ access to innovative new drugs.”To that end, at this fiscal year’s Central Social Insurance Medical Council (CSIMC) meetings, we have advocated for the implementation of “a mechanism ensuring that the value of innovative new drugs is appropriately reflected in drug prices upon initial listing” and “a mechanism ensuring that drug prices for new drugs during their patent term are maintained at levels comparable to those in other advanced nations.”

The recent outline of the drug pricing system reform includes the establishment of a new surcharge to recognize early introduction to Japan, a review of the evaluation criteria for pediatric medications, and the addition of new product requirements for the “New Drug Creation, etc. Surcharge.”Furthermore, measures have been taken to promote the appropriate evaluation of innovative new drugs, such as the abolition of “corporate indicators” under the New Drug Creation, etc., Surcharge and a review of how similar products are treated in market expansion reassessments.We recognize that these measures reflect the pharmaceutical industry’s long-standing advocacy for the evaluation and promotion of innovation, and we believe they represent an important step toward eliminating drug lag and drug loss. Furthermore, we view this as the beginning of Japan’s transformation into a nation that prioritizes innovation, thereby enabling improved patient access to new drugs.We express our respect to all those who contributed their efforts from various perspectives.
　
On the other hand, the outline of the cost-effectiveness evaluation system reform indicates that discussions will continue regarding the use of cost-effectiveness evaluations—beyond the scope of current price adjustments—for new drugs whose market size is expected to grow precisely because they are groundbreaking.As it is necessary to consider an appropriate system that does not hinder innovation,

we

intend to advocate for this during the ongoing discussions

. We hope to establish a system that ensures the early and reliable introduction of innovative new drugs to Japan, along with mechanisms for the appropriate evaluation of innovation and the maintenance of drug prices during the patent term, while also building a system that offers high transparency and is widely accepted by the public and all stakeholders.Furthermore, as there are issues identified by the “Expert Panel on Comprehensive Measures for the Rapid and Stable Supply of Pharmaceuticals” that require ongoing attention, we intend to actively participate in future discussions regarding reforms to the drug pricing system and the cost-effectiveness evaluation system, and we are committed to cooperating in the evaluation of this system review.

　

Organization Overview

Japan Pharmaceutical Manufacturers Association (JPMA)
The JPMA is a voluntary association comprising 71 research-and-development-oriented pharmaceutical companies (as of October 1, 2023).Established in 1968, the JPMA has contributed to global healthcare under the motto “Realizing Patient-Centered Healthcare” through the development of groundbreaking new prescription drugs.
JPMA carries out multifaceted initiatives, including addressing common issues facing the pharmaceutical industry, promoting a deeper understanding of pharmaceuticals, and fostering international collaboration. Furthermore, JPMA is committed to the sound development of the pharmaceutical industry, particularly through strengthening policy formulation and advocacy, responding to globalization, and enhancing public relations efforts.
Pharmaceutical Research and Manufacturers of America (PhRMA)
PhRMA is an organization representing the world’s leading research-based, innovative pharmaceutical companies. Its member companies discover and develop new medicines and strive to help patients live longer, healthier, and more active lives.Over the past decade, PhRMA member companies’ annual investment in the research and development of new treatments has more than doubled, reaching an estimated $101 billion in 2022 alone.

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