JPMA President's Press Conference JPMA's Vision for 2035 and JPMA's Policy Proposals for 2025 were released.

On February 26, 2025, the "JPMA President's Press Conference" was held at Muromachi Mitsui Hall & Conference (Chuo-ku, Tokyo).

At the same press conference, JPMA Chairman Hiroaki Ueno gave a presentation on his vision for the pharmaceutical industry, focusing on the "JPMA's Vision for 2035" and "JPMA's Policy Proposals for 2025," both of which were released on the same day. Looking back on the events and initiatives that have taken place since he became chairman, he introduced the vision of the pharmaceutical industry 10 years from now (Industry Vision 2035) based on the changes in the environment surrounding the industry, as well as his requests to the government and the efforts of the pharmaceutical industry over the next two years (Policy Proposal 2025) to realize the vision. Figure 3: Future vision of the pharmaceutical industry as a key industry

A lively Q&A session was held with 36 members of the press from 21 companies on the day of the event. The following is a summary of Chairman Ueno's presentation and the Q&A session with JPMA executives, including the Chairman.

Chairman's press conference

As a result of those activities, in FY2024, the NHI drug price reform system was revised in the direction that innovation is evaluated. In addition, the government positioned the pharmaceutical industry as a growth and key industry in Japan and clearly stated its commitment to strengthening drug discovery capabilities. However, it has been decided that a mid-year NHI price revision will be implemented in FY2025, amid soaring prices and wages. The same fiscal year is also the first year of the third phase of the Health and Medical Care Strategy, which was recently approved by the Cabinet, and while organizational reform of the Japan Agency for Medical Research and Development (AMED) and other related measures to strengthen drug discovery capabilities are under consideration, these measures must be formulated and implemented in a consistent and continuous manner. Looking back over the past two years, the shift in government policy toward strengthening drug discovery capabilities and evaluating innovation in FY2024 has been a positive trend, but the situation facing the pharmaceutical industry remains challenging, and many issues remain. ( Figure 1)

Figure 1: Recognition of issues at the Chairman's press conference

2. Vision of the JPMA's Vision for 2035

Comprised of three pillars under the banner of "Drug Discovery Innovation for Japan and the World

This is the first time in 10 years that the JPMA has formulated an industry vision. This vision outlines the vision of the pharmaceutical industry over a long-term span of 10 years, while looking ahead to the environment surrounding the industry 10 years from now.

The new "Industrial Vision 2035" basically follows the current "Industrial Vision 2025," but also takes into account changes in the global, domestic, and medical environments that have occurred over the past decade, as well as the changing role of the pharmaceutical industry. The JPMA is an association of pharmaceutical companies located in Japan, so we have added the word "Japan" to our mission statement, which is "Drug Discovery Innovation for Japan and the World," and have adopted the slogan "Contribute to Japan's economic growth by continuously creating innovation and extending healthy life expectancy," "Contribute to health security by rapidly delivering innovative new medicines to the public," "Ensure ethical and socially responsible business practices," and "Contribute to the development of a sustainable society. We have established the three pillars of "Innovation in Drug Discovery to Deliver to Japan and the World," "Contribute to Japan's economic growth by continuously creating innovation and extending healthy life expectancy," "Contribute to health security by rapidly delivering innovative new drugs to the public," and "Be an industry trusted by society by ensuring ethical standards and transparency. (2) The three pillars of the industry areFigure 2 )

Figure 2: Industrial Vision 2035 - Overall picture

JPMA's Policy Proposals for 2025

Three Pillars of Policy Recommendations

JPMA's Policy Proposals for 2025 have been prepared every two years from 2019 to 2021 and 2023, and now, in conjunction with the "JPMA's Vision for 2035," JPMA's Policy Proposals for 2025 have been formulated as "concrete action proposals for the next two years to realize the vision.

In order to realize the three pillars of the Industrial Vision 2035, the policy recommendations also consist of three pillars: the first, Innovation, addresses "the importance of strengthening Japan's drug discovery capabilities," the second, Access, addresses "the creation of an attractive Japanese market through appropriate evaluation of innovation," and the third, Trust, addresses "necessary initiatives to solve social issues. Access" and "Trust" corresponds to "necessary efforts to solve social issues" respectively. (See the table below.)Figure 3 )

Figure 3: From Industrial Vision 2035 to Policy Proposal 2025

Strengthening Drug Discovery Capability

JPMA has been stressing the importance of collaboration among the various players in the "drug discovery ecosystem. For example, in industry-academia collaboration, the key is how to combine discoveries and inventions from academia and link them to drug discovery research by pharmaceutical companies. ( Figure 4 )

Figure 4: Overall picture of measures to strengthen drug discovery capabilities

How to Cross the Devil's River

Currently, the steps of industry-academia collaboration have become very difficult. The reason lies in the "magic river," the large gap between basic research in academia and drug discovery research in industry. With the current diversification of drug modalities and players, the "magic river" lies before the "valley of death" between basic research and the clinical phase, and it is necessary for both academia and pharmaceutical companies to come together to cross this gap. Furthermore, in order to strengthen drug discovery capabilities, it is also necessary for the government to take the lead in developing drug discovery infrastructure and systems. ( Figure 5 )

Figure 5: Toward practical application of basic research in academia

Co-creation" with patients and citizens

Co-creation" with patients and the public is also a key concept in this vision and policy recommendations. There are many opportunities for pharmaceutical companies to "co-create" with patients and the public, such as providing biological samples and data at the research stage, reflecting their opinions in clinical trials, cooperating in improving convenience, and providing post-marketing safety information. JPMA will continue to improve patients' access to clinical trial information, and promote dialogue and public relations activities with patients and the public. ( Figure 6 )

Figure 6: Importance of patient and citizen participation in drug discovery

Appropriate Evaluation of Innovation

The second pillar of Policy Recommendation 2025 is "Appropriate Evaluation of Innovation. In order to bring innovative new drugs to the Japanese people as quickly as possible, the Japanese market must be attractive enough for the rapid introduction of new drugs. The three conditions for this are that the market as a whole must be a growing market, the NHI pricing system must be structured to promote innovation, and the system must be highly predictable in terms of business decisions (Figure 7). ( Figure 7 )

Figure 7: Toward a More Attractive Japanese Market

Rethinking Sealing.

Regarding the first point, "being a growing market," the global pharmaceutical market is rising steadily, but in Japan the market has reached a plateau. This is due to the current "ceiling" that allows only the growth of social security expenses equivalent to the aging of the population and does not allow growth due to high prices or the sophistication of medical care. However, the recently formulated "Third Health and Medical Care Strategy" clearly states that "the sales of pharmaceuticals in the Japanese market should be on an increasing trend. The strategy also states that "the market for pharmaceuticals in Japan should be on an upward trend. From now on, in addition to the aging of the population, the system should be able to reflect "the sophistication of medical care," "price trends and response to wage increases," and the efficiency of medical costs should be considered throughout healthcare, including the promotion of DX and the review of benefits and burdens. ( Figure 8 )

Figure 8.

A highly predictable system that enables the evaluation of the value of innovative new drugs

Regarding the second point, "appropriate evaluation of the value of innovation," the current NHI drug price calculation system includes two methods: the comparable drug price method, which refers to the prices of existing similar drugs, and the cost accounting method, which calculates costs by accumulating costs. Many of the recent innovative new drugs have been calculated using the cost-accumulation method, as there are no existing drugs to compare them with, partly due to the diversification of modalities. However, the value of such drugs cannot be adequately evaluated by accumulating costs. Therefore, as a new evaluation method, we are considering expanding the scope of application of the similar drug effect comparison method by flexibly determining the similarity of drugs according to disease and formulation characteristics. In the future, we will also consider a method in which companies themselves present the value of their pharmaceutical products and discuss them based on this value.

Regarding the third issue, "Establishment of a highly predictable NHI drug price system," in addition to annual NHI price revisions for eight consecutive years, the expanded rules for market expansion reimbursement have been introduced and immediately applied with each NHI price reform, making it difficult to evaluate the business potential of a product after its launch. Furthermore, there is a move to expand the cost-effectiveness evaluation system to be introduced in FY2019. JPMA believes that the government should change the patchwork measures it has taken so far and promote a fundamental review of the system. (SeeFigure 9 )

Figure 9: Expansion of the similar drug effect comparison method through flexible selection of similar drugs

4. Future Vision of the Pharmaceutical Industry

As a key industry in Japan

In order to continue to generate innovation at a rapid pace, it is important to have an industrial policy in which both the mechanism for the creation of innovative new drugs and the mechanism for the evaluation of innovation in terms of NHI prices are linked and circulating. As a high value-added industry, the pharmaceutical industry will continue its efforts to become a key industry in Japan by supporting the country's declining birthrate, aging society, and accelerating population decline. ( Figure 10 )

Figure 10. As a key industry in Japan  

5. Main Questions and Answers

Strengthening Drug Discovery Capability

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。
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。

The State of Social Security

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。
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。

Revision of the NHI Drug Price System

A3：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。

The Impact of the U.S. Trump Administration

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^{_{Fig. 1}}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。

Q&A session

(Nobuyuki Kobayashi and Akiko Fujiwara, Pharmaceutical Industrial Policy Committee)

TOP