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日米欧製薬3団体共同声明 2025年度(令和7年度)薬価中間年改定及び国家戦略に関する意見 (3 ページ)

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出典情報 日米欧製薬3団体共同声明 2025年度(令和7年度)薬価中間年改定及び国家戦略に関する意見(11/15)《日本製薬工業協会、米国研究製薬工業協会、欧州製薬団体連合会》
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Joint Statement on Proposals for the FY2025 Off-year Drug Price Revision
and National Biopharmaceutical Strategy
The Japan Pharmaceutical Manufacturers Association (JPMA), Pharmaceutical Research and
Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and
Associations (EFPIA) collectively represent the world’s leading biopharmaceutical research
companies operating in Japan. We congratulate Prime Minister Shigeru Ishiba on his new
administration and offer the following statement with the aim of realizing a society of health and
longevity through the research, development and stable supply of innovative medicines.
We have previously raised concerns about the state of Japan’s biopharmaceutical innovation
ecosystem, which is at a competitive disadvantage following nearly a decade of changes to drug
pricing rules and annual price cuts to patented medicines. Japan now faces a resurgence of
drug loss as life sciences investment continues to decline. We welcomed the FY2024 National
Health Insurance (NHI) drug pricing reform in December 2023 as an important first step to
reverse these negative trends.
However, to restore a globally competitive biopharmaceutical innovation ecosystem, Japan
must stay the course and not backslide on policy reforms. With this goal in mind, we propose
that the following policies should be prioritized in government decisions later this year.
Proposal 1: Abolish the FY2025 Off-year Drug Price Revision and Oppose Backsliding Policies
The FY2024 drug pricing reform improved the eligibility criteria for the Price Maintenance
Premium (PMP), increasing the likelihood that medicines launched in the future can maintain
their prices during the patent period. However, approximately half of innovative medicines still
receive annual price cuts.
Despite this, government discussions are underway to expand the rules applied in off-year drug
price revisions (e.g., early return of the PMP and market expansion repricing) and to expand the
role of cost-effectiveness analysis. These anti-innovation policies would reverse the positive
momentum of the FY2024 drug pricing reform and must be abandoned. Instead, Japan should
reaffirm the need for an NHI drug pricing system that incentivizes innovation and patient access.
Proposal 2: Create a New National Biopharmaceutical Strategy Under Cross-ministerial Body
With the right policies and plans, Japan can prevent drug loss, restore its global leadership in
drug discovery and attract global biopharmaceutical industry investment that drives economic
growth. A bold new national biopharmaceutical strategy and pro-innovation reforms are required
so that all parts of the biopharmaceutical innovation ecosystem function fully.
To realize this, Japan needs strong government leadership and collaboration with the private
sector. Next year’s Public-Private Council should develop a new national biopharmaceutical
strategy and KPIs under a permanent cross-ministerial body and include a platform for regular
dialogue with the global biopharmaceutical industry. We look forward to working with Japan as
partners to achieve these shared goals.