“JPMA Chairman’s Press Conference” Held Publication of JPMA’s Vision for 2035 and JPMA’s Policy Proposals for 2025
On February 26, 2025, the “JPMA Chairman’s Press Conference” was held at Muromachi Mitsui Hall & Conference (Chuo Ward, Tokyo).
At the press conference, Hiroaki Ueno, Chairman of the JPMA, gave a presentation on the pharmaceutical industry’s vision, focusing on the “JPMA’s Vision for 2035” (hereinafter “Vision for 2035”) and the “JPMA's Policy Proposals for 2025” (hereinafter “Policy Proposals for 2025”), both of which were released on the same day.While reflecting on events and initiatives since assuming the chairmanship, he introduced the industry’s vision for the next 10 years, taking into account changes in the environment surrounding the pharmaceutical industry(Industry Vision 2035), as well as the industry’s initiatives and requests to the government over the next two years to achieve this vision (Policy Proposals 2025). In conclusion, I presented a vision for the future of the pharmaceutical industry as a key sector of the economy.
On the day of the event, a lively question-and-answer session took place with 36 representatives from 21 media outlets. Below is a summary of Chairman Ueno’s presentation and the Q&A session with the JPMA’s executive officers, including the Chairman.
Scene from the Chairman’s press conference
1. A Look Back Since Taking Office as Chairman
Despite shifts in government policy, the situation remains severe
I would like to outline the challenges facing the Japanese pharmaceutical industry as I perceived them at the time of my appointment as Chairman of the JPMA (May 2023). In Japan, the industry had been slow to adapt to the diversification of drug modalities, and the development of new drugs had slowed.Furthermore, policies that placed excessive emphasis on curbing drug costs had exhausted pharmaceutical companies, leading to widening “drug lag” and “drug loss,” as well as instability in the supply of pharmaceuticals. To address these challenges, the JPMA has been working under the banner of “strengthening Japan’s drug discovery capabilities and fostering a virtuous cycle of appropriate evaluation of innovation.”
As a result of these efforts, in fiscal year 2024, the drug pricing system was revised to better recognize innovation.Furthermore, the government has positioned the pharmaceutical industry as a growth sector and a pillar of Japan’s economy, clearly demonstrating its commitment to strengthening drug discovery capabilities. However, it has been decided that an interim drug price revision will be implemented in fiscal year 2025 amid soaring prices and wages.Furthermore, fiscal year 2025 marks the first year of the Third Health and Medical Strategy, which was recently approved by the Cabinet. While measures to strengthen drug discovery capabilities—including organizational reforms at the Japan Agency for Medical Research and Development (AMED)—are under consideration, it is essential that these measures be planned and implemented with consistency and continuity.Looking back over the past two years, the government’s shift in fiscal year 2024 toward policies aimed at strengthening drug discovery capabilities and evaluating innovation was a positive development; however, the pharmaceutical industry continues to face a challenging situation, and many issues remain unresolved. ( Figure 1 )
Figure 1. Recognition of Challenges at the Chairman’s Press Conference
2. The Pharmaceutical Industry’s Vision—JPMA’s Vision for 2035—
Under the banner of “Drug Discovery Innovation for Japan and the World,” the vision is structured around three pillars
We have formulated the JPMA’s Industry Vision for the first time in 10 years. This vision outlines the pharmaceutical industry’s goals over a 10-year period, while anticipating the environment surrounding the industry 10 years from now.
The new “Industrial Vision 2035” essentially builds upon the current “Industrial Vision 2025,” while also taking into account the changes in the global and domestic situations, the healthcare environment, and the evolving role of the pharmaceutical industry over the past decade.As the JPMA is an organization of pharmaceutical companies based in Japan, we have adopted the slogan “Drug Discovery Innovation for Japan and the World,” adding the phrase “our country.” We have established three pillars: “Continuously generating innovation to contribute to Japan’s economic growth while extending healthy life expectancy,” “Rapidly delivering innovative new drugs to the public to contribute to health security,” “Ensure ethical standards and transparency to become an industry trusted by society.” (Figure 2 )
Figure 2. Industry Vision 2035 – Overview –
3. Toward Realizing Our Vision – JPMA's Policy Proposals for 2025 –
The Three Pillars of Policy Proposals
The JPMA has been issuing policy proposals every two years since 2019—in 2021 and 2023—but this time, in conjunction with “JPMA’s Vision for 2035,” it has formulated “JPMA's Policy Proposals for 2025” as “proposals for concrete actions over the next two years to realize the vision.”
To realize the three pillars of “Industrial Vision 2035,” our policy proposals are also structured around three pillars.The first pillar, “Innovation,” corresponds to “the importance of strengthening Japan’s drug discovery capabilities”; the second pillar, “Access,” corresponds to “the creation of an attractive Japanese market through the appropriate evaluation of innovation”; and the third pillar, “Trust,” corresponds to “necessary initiatives to address social challenges.” (Figure 3 )
Figure 3. From Industry Vision 2035 to Policy Proposals 2025
Strengthening Drug Discovery Capabilities
The JPMA has long emphasized the importance of collaboration among all players in the “drug discovery ecosystem.” For example, in industry-academia collaboration, the key lies in how to integrate academic discoveries and inventions into the drug discovery research of pharmaceutical companies. ( Figure 4 )
Figure 4. Overview of Measures to Strengthen Drug Discovery Capabilities
How to Cross the “River of Demons”
Currently, collaboration between industry and academia has become extremely difficult.The root cause lies in the “River of Demons”—a significant gap between basic research in academia and drug discovery research in the private sector. With the diversification of pharmaceutical modalities and industry players today, the “River of Demons” now precedes the “Valley of Death” between basic research and the clinical phase; overcoming this requires both academia and pharmaceutical companies to meet each other halfway.Furthermore, to strengthen drug discovery capabilities, it is necessary for the government to take the lead in developing the infrastructure and systems for drug discovery. ( Figure 5 )
Figure 5. Toward the Practical Application of Basic Research in Academia
“Co-creation” with Patients and Citizens
Furthermore, this vision and policy proposal highlight “co-creation” with patients and citizens as a key concept.There are numerous opportunities for pharmaceutical companies to engage in “co-creation” with patients and citizens, such as through the provision of biological samples and data during the research phase, incorporating feedback into clinical trials, cooperating to improve convenience, and providing post-marketing safety information.The JPMA will continue to advance initiatives such as improving patient access to clinical trial information, engaging in dialogue with patients and the public, and conducting public relations activities. ( Figure 6 )
Figure 6. The Importance of Patient and Citizen Participation in Drug Discovery
Appropriate Evaluation of Innovation
The second pillar of the Policy Proposals 2025 is “Appropriate Evaluation of Innovation.”In order to deliver innovative new drugs to the Japanese public as quickly as possible, the Japanese market must be attractive enough to support the rapid launch of new drugs. There are three conditions for this: the market as a whole must be a growing market; the drug pricing system must be structured to promote innovation; and the system must provide a high degree of predictability for business decisions. ( Figure 7 )
Figure 7. Enhancing the Attractiveness of the Japanese Market
Reviewing Price Caps
Regarding the first point—that it is a “growing market”—while the global pharmaceutical market is on an upward trajectory, the Japanese market has plateaued.This is because, under the current system, there is a “ceiling” that allows for growth in social security expenditures only to the extent attributable to the aging population—growth resulting from rising prices or advances in medical technology is not permitted—and much of the increase beyond that attributable to the aging population is curbed through drug price revisions (reductions).However, the recently formulated “Third Health and Medical Strategy” explicitly states, “We will put the Japanese pharmaceutical market on a growth trajectory.”Going forward, the system should be designed to reflect not only an aging population but also “advances in medical technology” and “price trends and wage increases.” Regarding the efficiency of medical expenses, we should take a holistic approach across the entire healthcare sector, including the promotion of digital transformation (DX) and a review of benefits and cost-sharing. ( Figure 8 )
Figure 8. The Need to Revise the Ceiling on Social Security Expenditures
A System Capable of Evaluating the Value of Innovative New Drugs and Providing High Predictability
Regarding the second pillar, “Appropriate Evaluation of the Value of Innovation,” the current drug pricing calculation methods include the “comparison with similar drugs” method, which references the prices of existing similar drugs, and the “cost-based calculation” method, which uses a cost-plus approach. Due to the diversification of modalities, many recent innovative new drugs lack comparable existing drugs, and as a result, most are priced using the cost-based calculation method.However, the cost-based approach does not fully evaluate the value of the drug in question. Therefore, as a new evaluation method, we are considering flexibly assessing the similarity of drugs based on disease characteristics and formulation characteristics, thereby expanding the scope of application for the comparative efficacy method.Furthermore, in the future, we will explore an approach in which companies themselves present the value of their pharmaceuticals, and discussions proceed based on those presentations.
Furthermore, regarding the third point—“Establishing a Highly Predictable Drug Pricing System”—in addition to annual drug price revisions for eight consecutive years, expanded rules for market expansion reassessment have been introduced and immediately applied with every reform of the drug pricing system, making it increasingly difficult to evaluate the business viability of drugs after market launch.Furthermore, there are moves to expand the cost-effectiveness evaluation system introduced in fiscal year 2019. JPMA believes the government should abandon its piecemeal approach and proceed with a fundamental overhaul of the system. (Figure 9 )
Figure 9. Expansion of the Comparative Efficacy Assessment Method for Generic Drugs Through Flexible Selection of Comparator Drugs
4. The Future of the Pharmaceutical Industry
As a Core Industry of Japan
To continue generating innovation rapidly, it is essential to have a cyclical industrial policy in which the mechanisms for creating innovative new drugs and the mechanisms for evaluating innovation in drug pricing work in tandem.We will continue to strive to ensure that the pharmaceutical industry, as a high-value-added sector, serves as a pillar of Japan’s economy by underpinning the nation amid accelerating demographic challenges such as a declining birthrate, an aging population, and population decline. ( Figure 10 )
Figure 10. As a Core Industry of Japan
5. Key Q&A
Strengthening Drug Discovery Capabilities
Q1: You mentioned AMED’s organizational reform earlier, but separately from that, a framework and fund centered on the National Institute of Biomedical Innovation, Health and Nutrition (NIBIOHN) are currently being established. I would like to ask how you view this.
A1: I would like the government to be aware that if it intends to create multiple support frameworks—or if the frameworks are similar yet distinct—it must clearly define the division of roles among them. Furthermore, I want the government to recognize that these frameworks will only be effective if they are interconnected, rather than merely having their roles divided.Furthermore, should the National Institute of Biomedical Innovation, Health and Nutrition’s framework encounter difficulties, I would like to propose a forum to discuss these challenges, as this is an issue affecting the nation as a whole.
Q2: Could you please explain the definition of a “key industry”?
A2：基幹産業とは何かと端的に表現するなら、世の中で必要とされる産業というのが前提。また3つの要素として「国民の健康寿命の延伸」、健康の観点から国や国民を守る治療薬やワクチンなどの「健康安全保障」、また、産業の観点から日本発のイノベーションや知的財産を基に世界に出て「日本の成長や発展に貢献」することをもって、基幹産業になりうると考える。製薬産業は資源の乏しい日本にマッチしていると考えている。
Q3: Isn’t it possible for individual companies to take steps to strengthen their drug discovery capabilities on their own? What will the industry association do?
A3：大学や地域のエコシステムには個社単位でも参画していると思うが、業界団体としては、国や団体等を相手にした広範囲な観点での支援を考えている。たとえば、AMEDに製薬産業から人が加わることで、どのような成果が出るのか、といった横断的な課題や解決策を考えるのは、業界団体でないとなかなかできないと考えている。
On the Future of Social Security
Q4: Regarding the review of the ceiling on social security-related expenditures (the upper limit designed to curb spending growth), could you tell us when and how you plan to pursue this?
A4：近年、国庫歳入は増加しているにも関わらず、社会保障費は従来通りの方法で圧縮されている。財政当局は物価上昇や賃上げ等に配慮しているというが、配慮の度合いが見えない。まずは次の2026年度の本格改定に向けて、ステークホルダーと議論をし、具体的に訴えていきたい。
Q5: You mentioned benefits and financial burdens, but public sentiment toward medical expenses is strongly critical, and I believe a review would be extremely difficult.
A5：国民皆保険の堅持を前提とすると、一定の財源の中で何を保険で賄うかということになる。一般的な考えでは高額医療は公助を維持し、軽医療は個人負担でとなるだろう。この問題を解決せねば、日本の医療環境が崩れるであろうことも事実である。より一層、国民的な議論をし、解決していく必要がある。
Review of the Drug Pricing System
Q6: Regarding drug price calculations, you state that a review is needed to establish a system that better evaluates value. However, even under the current cost-based pricing method—which is considered problematic—add-ons such as the “breakthrough innovation surcharge” are already possible. What is the rationale for proposing the expansion of the “comparison of similar therapeutic effects” method? Also, are drugs the only items used for comparison?
A6：類似薬効比較方式は原価算定方式よりも予見性が高まる１つの方法として考えている。類似する既存薬がなくとも、医療技術等を含めて比較できる事例が増えてくれば、類似薬効比較方式のレベルも上がり、医薬品の効果をより広く示すことができるのではと考えている。
Impact of the Trump Administration in the United States
Q7: U.S. President Donald Trump has declared that pharmaceuticals will be subject to new tariffs. What impact will this have?
A7：医薬品関税として25％賦課が表明されている。医薬品関税は1994年のウルグアイ・ラウンド*で撤廃され、その後は開発や製造コストが低減したことを踏まえると、関税賦課となれば医薬品、特に難病や希少疾患の薬剤の開発が停滞し、全人類に薬が届かない恐れがある。現時点では具体的な政策は出されていないので、状況を注視しているところである。
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*Multilateral trade negotiations under the GATT (General Agreement on Tariffs and Trade, established in 1948), which have been held in Uruguay, South America, since 1986.
Q&A Session
(Pharmaceutical Industrial Policy Committee: Nobunori Kobayashi, Shoko Fujiwara)