“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 “JPMA’s Vision for 2035” (hereinafter “Vision for 2035”) and “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) in light of the changing environment surrounding the pharmaceutical industry, as well as the industry’s initiatives and requests to the government for the next two years aimed at realizing this vision (Policy Proposals 2025). In conclusion, I presented a vision for the future of the pharmaceutical industry as a key industry.
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 will 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, leading to a slowdown in new drug development.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 key industry for Japan, 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 Industrial 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.Since 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 recommendations 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 drug modalities and industry players today, the “River of Demons” now exists before 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 Commercialization 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 citizens, 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
Revising the Ceiling
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 recognizes growth in social security expenditures only to the extent attributable to the aging population—excluding increases due to rising prices or advances in medical technology—and much of the increase beyond that caused by aging is curbed through drug price revisions (reductions).However, the recently formulated “Third Health and Medical Strategy” explicitly states, “We will put the domestic 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 view of the healthcare system as a whole, 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 calculates prices by adding up costs. 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 determining 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 proposals.
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 reassessments 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 Generic Drugs
4. The Future of the Pharmaceutical Industry
As a Key Industry in 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 through 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—including a declining birthrate, an aging population, and population decline—and thereby solidify its position as a core industry. ( Figure 10 )
Figure 10. As a Key Industry in Japan
5. Key Questions and Answers
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 separate roles.Furthermore, should the NIHS 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 define what
by “key industries”?
: To put it simply, key industries are those that are necessary to society.Furthermore, I believe an industry can qualify as a core industry if it meets three criteria: “extending the healthy life expectancy of the population”; “health security,” which involves medicines and vaccines that protect the nation and its people from a health perspective; and, from an industrial perspective, “contributing to Japan’s growth and development” by expanding globally based on Japanese innovations and intellectual property.I believe the pharmaceutical industry is well-suited to Japan, a country with limited natural resources.
: Isn’t it possible for individual companies to take steps to strengthen drug discovery capabilities on their own? What initiatives will you undertake as an industry association?
A3: While individual companies do participate in university and regional ecosystems, as an industry association, we are considering providing support from a broad perspective, engaging with the government and other organizations. For example, we believe that only an industry association can effectively address cross-cutting issues and solutions—such as what outcomes might result from having representatives from the pharmaceutical industry join AMED.
On the Future of Social Security: I would like to ask when and how you plan to call for a review of the ceiling on social security-related expenditures (the upper limit designed to curb spending increases).
: In recent years, despite an increase in national tax revenue, social security expenditures have been cut using the same methods as before. While fiscal authorities claim to be taking inflation and wage increases into account, the extent of this consideration is unclear. First, looking ahead to the full-scale revision scheduled for fiscal year 2026, we intend to engage in discussions with stakeholders and make specific appeals.
: You mentioned benefits and burdens, but there is strong public backlash against medical expenses, and I believe a revision will be extremely difficult.
A5: Assuming we maintain universal health insurance, the question becomes what should be covered by insurance within a fixed budget.The general consensus is that public assistance should be maintained for high-cost medical care, while individuals should bear the costs for minor medical care. It is also a fact that unless this issue is resolved, Japan’s healthcare system will collapse. We need to foster even broader national debate and work toward a solution.
Regarding the Review of the Drug Pricing System: Regarding drug price calculations, you have stated that a review is needed to establish a system that better evaluates value. However, even under the current cost-based calculation method—which is considered problematic—add-ons such as the “innovative contribution” can be applied. What is the rationale for proposing the expansion of the “comparison of similar therapeutic effects” method? Also, are drugs the only items subject to comparison?
A6: We view the “similar therapeutic effect comparison method” as one approach that offers greater predictability than the cost-based calculation method. Even if there are no existing drugs with similar effects, we believe that as the number of cases where comparisons can be made—including those involving medical technologies—increases, the standard of the “similar therapeutic effect comparison method” will rise, allowing us to demonstrate the efficacy of pharmaceuticals more broadly.
Impact of the Trump Administration in the U.S.: U.S. President Donald Trump has announced that pharmaceuticals will be subject to new tariffs. What impact will this have? A7 : A 25% tariff on pharmaceuticals has been announced. Tariffs on pharmaceuticals were eliminated under the 1994 Uruguay Round
- *, and given that development and manufacturing costs have decreased since then, the imposition of such tariffs could stall the development of pharmaceuticals—particularly those for intractable and rare diseases—and there is a risk that medicines will not reach people worldwide. As no specific policies have been announced at this time, we are closely monitoring the situation.
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