Joint Statement by the Pharmaceutical Manufacturers' Associations of Japan, the U.S., and Europe:
Joint Statement on Reform of the NHI Drug Price System and Cost-Effectiveness Assessment System in Fiscal 2024

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December 20, 2023
Japan Pharmaceutical Manufacturers Association (JPMA)
Pharmaceutical Research and Manufacturers of America (PhRMA)

The Central Social Insurance Medical Council (Chuikyo) has recently released the "Framework for Fiscal 2024 NHI Drug Price Reform (hereinafter referred to as the "Framework for NHI Drug Price Reform")"

and

the "Framework for Fiscal 2024

Cost-Effectiveness

Evaluation

System

Reform (hereinafter referred to

as

the "

Cost-Effectiveness Evaluation

System

Reform

"

)". The Central Social Insurance Medical Council (Chuikyo) has recently compiled the "Framework for Reform of the NHI Drug Price System in FY2024" and the "Framework for Reform of the Cost-Effectiveness Evaluation System in FY2024". The "Framework for Reform of the NHI Drug Price System" and the "Framework for Reform of the Cost-Effectiveness Evaluation System in FY2024" were compiled.
From the standpoint of the pharmaceutical industry, which aims to realize a healthy society with longevity through the research, development, and stable supply of innovative new drugs, we would like to express our opinions as follows.

The three pharmaceutical industry associations of Japan, the U.S., and Europe have made it their basic policy to "achieve both the promotion of innovation and the sustainability of universal health coverage, and to improve patients' access to innovative new medicines. To this end, we have appealed at this year's Chuikyo for the realization of "a system in which the value of innovative new drugs is appropriately reflected in NHI prices when they are newly listed on the market" and "a system in which NHI prices for new drugs during the patent period are maintained at the same level as in developed countries outside Japan.

The NHI drug price reform framework includes the establishment of a new additional drug allowance to evaluate the early introduction of new drugs into Japan, a revised evaluation of pediatric drugs, and the addition of new drug requirements to the additional drug allowance for the creation of new drugs. In addition, measures were taken to promote the appropriate evaluation of innovative new drugs, such as the elimination of the "company indicator" for the additional payment for new drug creation, etc. and a review of the treatment of similar products for the re-calculation of market expansion. We recognize that these measures are based on the pharmaceutical industry's past advocacy of evaluating and promoting innovation, and we believe that they represent an important step forward in eliminating the drug lag/loss. I also believe that this is the beginning of Japan's transformation into an innovation-oriented country that can improve patients' access to new drugs. I would like to pay tribute to all of you for your efforts in various capacities.
　
On the other hand, the framework for reform of the cost-effectiveness evaluation system indicates that discussions will continue on the use of cost-effectiveness evaluation beyond the current price adjustment range for new drugs that have a large market size because they are groundbreaking new drugs. We would like to make this appeal in the ongoing discussion because it is necessary to consider an appropriate system that does not hinder innovation.

We hope to see the establishment of a system that is transparent and convincing to all stakeholders, including the public, as well as the construction of a mechanism for the appropriate evaluation of innovation and the maintenance of drug prices during the patent period, so that innovative new drugs can be introduced into Japan as quickly and reliably as possible. We will actively participate in future discussions on reform of the NHI drug pricing system and the cost-effectiveness evaluation system, and will cooperate in the verification of this review. We will actively participate in future discussions on reform of the NHI drug pricing system and cost-effectiveness evaluation system.

Thank you for your continued

support

.

Organization Profile

Japan Pharmaceutical Manufacturers Association (JPMA)
The JPMA is a voluntary association of 71 R&D-oriented pharmaceutical companies (as of October 1, 2023). established in 1968, the JPMA has contributed to global healthcare through the development of innovative new drugs for ethical drugs under the motto "Realization of patient-participatory medicine.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) is engaged in a multifaceted program of activities to solve various problems common to the pharmaceutical industry, to deepen understanding of pharmaceuticals, and to promote international collaboration. In particular, we are working for the sound development of the pharmaceutical industry by strengthening our policy formulation and advocacy activities, addressing internationalization, and reinforcing our public relations system.
Pharmaceutical Research and Manufacturers of America (PhRMA)
PhRMA represents the world's leading research-oriented innovative pharmaceutical companies. Member companies strive to discover and develop new medicines and help patients live longer, healthier, and more active lives. Over the past decade, PhRMA member companies have more than doubled their annual investment in research and development of new therapies, reaching an estimated $101 billion in 2022 alone.

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