Pharmaceutical Industrial Policy Committee

Priority Issues

  1. Comprehensive study of measures from the perspective of innovative new drugs and innovation creation
  2. Realization of a drug price system that appropriately evaluates innovation and contributes to the growth of the R&D-based pharmaceutical industry
  3. Promotion of efforts to eliminate drug lag and loss
  4. Further enhancement and utilization of the tax system to promote the creation of innovative new drugs and strengthen international competitiveness
  5. Establish an environment for the creation of innovative new drugs in cooperation with relevant ministries and the Japan Agency for Medical Research and Development (AMED), etc.
  6. Strengthen efforts to promote the proper use of pharmaceuticals
  7. Promote initiatives related to infectious diseases
  8. Promote initiatives related to economic security
  9. Promote initiatives related to intractable and rare diseases
  10. Promote strategic advocacy activities based on industrial policy and security perspectives
  11. Responding to import/export, customs, and other trade-related issues related to the pharmaceutical industry (International Trade Committee (ITC))
  12. Responding to international discussions on access to digital sequence information (DSI) and other information and benefit sharing (ABS) under the Convention on Biological Diversity (CBD-ABS TF)

Priority Tasks to be addressed

1. study comprehensive measures from the viewpoint of innovative new drugs and innovation creation

  • Understand and analyze the scientific and technological changes surrounding the R&D-based pharmaceutical industry, changes in the social environment, and policy trends, and conduct a comprehensive review from the perspective of responding to public needs and social issues through the creation of innovative new drugs and innovations, focusing on innovation promotion measures, the drug pricing system, and the tax system, which are the cornerstones of industrial policy, and make recommendations and The committee will make recommendations and responses. In addition, the committee will respond to the various councils established under the health and medical care strategy, public-private dialogue and public-private councils, and the Japan Growth Strategy Council, as well as to issues and urgent matters that cannot be addressed by the standing committees, and organize the content, direction, etc., that should be advocated.
  • In considering and responding to these issues, the committee will collaborate with related organizations and utilize the research and survey functions of The Office of Pharmaceutical Industry Research.

2. realization of a drug pricing system that appropriately evaluates innovation and contributes to the growth of the R&D-oriented pharmaceutical industry

  • The Office of Pharmaceutical Industry ResearchThe basic policy is to achieve predictable compatibility between "an attractive Japanese market that enables cyclical recovery of R&D investment and where the various values of new drugs are transparently and appropriately evaluated" and "sustainability of universal health coverage" and to improve patients' access to innovative new drugs. With this in mind, we will continue to focus on the establishment and realization of a system to more appropriately evaluate innovations in new drugs, including responses to the 2027 NHI price revision and verification of the cost-effectiveness evaluation system, in cooperation with and related committees as well as related organizations.
  • JPMA's Policy Proposals for 2025, the discussions at the Public-Private Consultative Working Group for Enhancing Drug Discovery Capability, and the framework for reform of the NHI drug price system in FY2026, we will actively participate in discussions in the public and private sectors and make timely and appropriate proposals, etc. We will also work to abolish the application of the expanded re-calculation (including special exceptions) of the market to similar drugs (so-called co-matching), which was realized under the reform of the system in FY2026. We will continue to analyze and evaluate the impact on drug development, including the elimination of drug-lag and loss, etc., while keeping abreast of domestic and international trends, such as the revision of the pharmaceutical affairs system and the MFN (Most Favored Nation) system in the U.S., with a focus on measures to evaluate innovative new drugs and maintain prices, including the abolition of the so-called "co-promotion" system, which was achieved under the FY2026 reforms. In addition, the review will be promoted from the perspectives of reflecting economic and price trends, addressing social issues such as strengthening Japan's drug discovery capabilities, strengthening the global environment and international competitiveness of the pharmaceutical industry, and increasing the transparency and acceptability of NHI drug price calculation. In particular, the JPMA has proposed at the Chuikyo and other meetings that the NHI should adopt a "NHI price calculation method for innovative new drugs," "innovative new drug price maintenance system," and "special re-calculation for market expansion (special price adjustment for sustainability)," which were postponed in the FY2026 reform. We will continue to study specific proposals and make recommendations in preparation for the FY2028 reform.
  • With regard to cost-effectiveness evaluation, we will closely examine the framework of the FY2026 institutional reform and the contents of related notifications and analytical guidelines, and further strengthen cooperation with government, academia, and other relevant parties in order to resolve issues. Regarding the "verification" of the system that is scheduled to be implemented, we will cooperate to improve the system and issue accurate opinions. At the same time, we will organize issues for the next reform of the system and issue proposals as appropriate. In particular, since the current system is focused on reducing the price of innovative new drugs, we will organize our views on the positioning and use of cost-effectiveness evaluation in the NHI drug price system, including preventing the expansion of the scope of coverage and price adjustment, and actively promote activities to ensure that the system is appropriate and does not inhibit innovation.
  • In order to enhance the presence of the pharmaceutical industry, to stimulate discussion and promote understanding of the various values of pharmaceuticals and their evaluation, and to contribute to social implementation, we will continue to visualize the value of pharmaceuticals and the contribution of the pharmaceutical industry to society, and develop activities in cooperation with related committees and subcommittees.
  • Continuously research and analyze the latest trends in various systems related to medical care and pharmaceuticals, including the reform of the medical insurance system decided in the FY2026 budgeting process, and from the perspective of ensuring patients' access to medicines and the sustainability of the universal health insurance system, organize the industry's basic thinking on benefits and burdens, as well as the necessary Examine the measures to be taken, and promote discussions and proposals with related parties.

3. promotion of initiatives to eliminate drug lag and loss

  • In order to prevent a vicious cycle that leads to further drug lag/loss through the decline in the international attractiveness of the Japanese market, we will continue to raise issues and make policy proposals to the government to improve the drug discovery environment in Japan and to establish a system in which innovation is appropriately evaluated. In addition, we will promote understanding of the Japanese market among overseas start-ups and global companies, and create an environment that encourages them to choose Japan as a development and launch destination. Furthermore, the committee will continue to identify and analyze the actual conditions and factors of drug losses that have already emerged, with the aim of making effective improvements in systems and operations. JPMA will promote the sharing of information on the content and progress of efforts to eliminate drug loss in related committees and policy institutes, and work with the government to address various issues.
  • The MFN pricing policy in the U.S. may have a negative impact on the development and launch of new drugs in Japan, and from the perspective of further enhancing the evaluation of innovative drugs and the maintenance of drug prices during the patent period, we will propose a specific proposal as a flexible response during the term, without waiting for NHI price reform, and hold discussions in cooperation with the public and private sectors. Discussions will be held.
  • Strengthen dissemination of information on the Japanese market and NHI regulations to overseas start-ups and global companies; provide accurate and easy-to-understand information on the Japanese NHI system and market environment in cooperation with the PMDA U.S. office and JETRO New York office, and support overseas companies entering the Japanese market. Cooperate with matching measures, etc., to support foreign companies entering the Japanese market. This will lower the psychological and practical hurdles to the development and launch of drugs in Japan and promote their early introduction.
  • Conduct ongoing information updates and surveys on drug-loss items that have emerged, and follow up on the status of development requests, etc., through the "Review Committee on Unapproved and Off-label Drugs of High Medical Need. The committee will conduct in-depth analysis of drug-loss bottlenecks and categorize issues regarding factors preventing progress in domestic development, structurally analyze from the perspective of business feasibility, systems, clinical trial environment, etc., and organize and propose necessary system improvements and support measures based on the results of this analysis.

4. further enhancement and utilization of taxation system to promote the creation of innovative new drugs and strengthen international competitiveness

  • With regard to the tax breaks for strategic technology areas and capital investment that will be newly established in the FY2026 tax reform, we will discuss the details of the provisions with METI and others in preparation for the revision of the Industrial Competitiveness Enhancement Law and the establishment of guidelines, to ensure that the agreed items are reflected, to establish clear application criteria and a simple operation method, and to improve the results of utilization after the system comes into effect. We will also establish clear application standards and a simplified method of operation, and improve the results of utilization of the system after it comes into effect. With regard to overseas contract research expenses, in order to demonstrate the importance of overseas contract research expenses other than clinical trials, for which the percentage of tax deductible expenses will be phased out from FY2026, and to dispel the misconception that the JPMA industry with a high ratio of overseas sales contributes little to Japan's tax revenue, we will work with the relevant committees and subcommittees to generate evidence to disprove this misconception and raise awareness among policymakers. In addition, we will work with related committees and subcommittees to create evidence to disprove the misconception that the pharmaceutical industry with a high ratio of overseas sales contributes little to Japan's tax revenue.
  • The Ministry of Economy, Trade and Industry (METI) and others should be encouraged to revise the taxation system for innovation hubs to make it easier to apply in practice, and to examine the scope of eligible patents, the level of income tax deductibility, and other systemic issues.

5. improve the environment for the creation of innovative new drugs in cooperation with relevant ministries and AMED, etc. 6.

  • With regard to the measures to support the creation of innovative new drugs, etc., as outlined in the Drug Discovery Initiative Council, the Third Health and Medical Care Strategy, and the Plan for the Promotion of R&D in Medical Fields, etc., we will make timely and appropriate proposals to the relevant ministries, agencies, and other bodies to ensure their effectiveness and to make them truly beneficial to the pharmaceutical industry. In addition, the committee will collaborate with related ministries, agencies, AMED, etc., on the following issues proposed in Policy Proposal 2025: "Measures to create innovative new drugs from Japan," "Development of R&D infrastructure," "Establishment of medical data infrastructure and legal system to realize efficient, citizen- and patient-centered healthcare," "Acceleration of efforts to realize genomic medicine," and "Human resource development in drug discovery science, Promote "establishment of medical data infrastructure and development of legal system to realize efficient patient-centered medicine," "acceleration of efforts to realize genomic medicine," and "fostering human resources for drug discovery science" through collaboration with related committees, as well as by lobbying related ministries and agencies and AMED. Promote AND-E, the collaboration agreement with AMED concluded in October 2025 based on policy recommendations, in collaboration with both parties.

6. strengthen efforts to promote the proper use of pharmaceuticals

  • Based on the policy recommendations, promote the study and development of specific measures to promote the appropriate use of pharmaceuticals, including the appropriate provision of information, measures to deal with polypharmacy and drug residues, AMR, and the optimal use of expensive drugs, in collaboration with related committees and in cooperation with healthcare-related organizations, insurer organizations, academia, and other organizations. Promote the development and implementation of specific measures in cooperation with healthcare-related organizations, insurers' groups, academia, etc.

(7) Promote initiatives related to infectious diseases (8) Promote initiatives related to economic security

  • With respect to efforts to deal with infectious diseases and issues to be addressed in normal times and in the event of an outbreak of infectious diseases, the committee will promote the study of measures necessary to secure and stably supply medical countermeasures for infectious diseases, including therapeutic drugs and vaccines, in cooperation with the relevant committees, including information sharing.

8. promotion of initiatives related to economic security

  • In the U.S., under the second Trump administration's "America First" policy, the U.S. government has made the return of manufacturing to the domestic market a pillar of its policy and has been promoting tariffs and introducing MFN drug pricing policies in the area of new drugs. The outlook of the international situation surrounding the industry is becoming increasingly uncertain in areas such as security and supply chains. The outlook for the international situation surrounding the industry is becoming increasingly uncertain in areas such as security and supply chains, The pharmaceutical industry also needs to watch domestic and global trends from the perspective of economic security and take necessary actions to strengthen supply chains, competition in advanced technologies, cyber-security measures, and data security. The Economic Security Task Force will endeavor to collect and analyze relevant information, as well as consider, adjust, and respond to policies as appropriate on matters that require industry policy formulation, and conduct educational activities for member companies.

9. promotion of initiatives on intractable and rare diseases

  • Based on the recommendations (released in January 2025) prepared based on the results of the "Survey on Problems of Healthcare Professionals" released in November 2024, promote activities in cooperation with various stakeholders related to intractable and rare diseases, including patient groups, healthcare professionals, government, and academia.

10. promotion of strategic advocacy activities based on industrial policy and security perspectives

  • Based on the JPMA's Policy Proposals for 2025, the JPMA's Policy Proposals for 2025, etc., the JPMA's Policy Proposals for 2025 and other short-term issues, as well as medium- and long-term issues such as promoting understanding of the JPMA's Policy Proposals for 2025 to the public, will be formulated and strategic advocacy activities will be promoted in cooperation with related committees and subcommittees.
  • Continue and promote systematic visitation activities to stakeholders who influence national policy making in the medical and pharmaceutical fields, in order to deepen stakeholders' understanding of pharmaceutical industry policies, by expanding the multilayered visitation system consisting of top executives of each company, executive-level officials, and working-level officials.
  • With regard to the research public solicitation project launched in FY2023, follow up on the themes adopted in the first through third rounds of solicitation, and develop activities for the fourth round of solicitation while formulating the next three-year plan. Through these and other activities, promote academia research that contributes to the promotion of industry understanding.
  • As part of public awareness activities, promote activities to help pharmacists and academia understand the environment surrounding the pharmaceutical industry and drug discovery through strengthening relationships with people in the pharmaceutical industry and academia.
  • To deepen the public and patients' understanding of the pharmaceutical industry, the committee will formulate target-specific strategies for promoting understanding by strengthening ties with the Public Affairs Committee and related Patient Cooperation Committees, and promote activities aimed at shaping public opinion through the use of a wide range of media.
  • Drug Discovery ・Disseminate the attractiveness and importance of life sciences and the pharmaceutical and pharmaceutical industry, especially to children and students, and work to expand the base of human resources who will lead the future of the pharmaceutical and life science fields. Practice science communication through broad collaboration with science museums, academic societies, schools, etc.

11. addressing import/export, tariffs, and other trade-related issues related to the pharmaceutical industry

(1) Basic Policy

  • The International Trade Committee (ITC) will focus on the smooth implementation in Japan of the elimination of tariffs on pharmaceuticals and pharmaceutical intermediates based on international treaties (revision of the WTO concession list), and will appropriately address other issues related to trade, such as imports and exports, tariffs, etc., in the pharmaceutical industry by collecting domestic and international information and collaborating with related organizations. We will appropriately deal with other issues related to trade, including imports and exports, tariffs, etc., pertaining to the pharmaceutical industry, by gathering information both domestically and internationally and cooperating with related organizations.

(2) Priority issues

  1. Appropriate response to U.S. tariff measures
  2. Early realization of the elimination of the fifth round of pharmaceutical tariffs
  3. Address various issues related to the Pharmaceutical Affairs Law and trade

3）Details of efforts to address priority issues

1) Appropriate response to U.S. tariff measures: Coordination and cooperation with related organizations and exchange of views with the Japanese government

  • We will monitor developments in U.S. tariff policy on pharmaceuticals and respond to them in close cooperation and collaboration with related JPMA committees and related industries and organizations.

2) Early realization of the elimination of the fifth round of pharmaceutical tariffs

  • Although the fifth round of tariff elimination work is still stalled, we will cooperate with relevant ministries and INTERCEPT, etc. and prepare a tariff elimination list for submission to the Diet so that when the work is resumed, it can be resumed smoothly.

(iii) Response to the Pharmaceutical Affairs Agency Law and related laws and regulations, and various trade issues: Continuation of research, information gathering activities, and educational activities; coordination and cooperation with other organizations; implementation of workshops, lectures, etc.; and exchange of information among committee members.

  • We will continue to work in close cooperation and collaboration with related committees within JPMA and related industries and organizations to ensure compliance with and appropriate application of the Pharmaceutical Affairs Act and related laws and regulations.
  • The number of contracts entrusted to manufacturers, including overseas manufacturers, is increasing, and in order to deal with various problems related to the Pharmaceutical Affairs Law, the Customs Law, the Chemical Substances Control Law, and other laws and regulations that arise as a result of the expansion of import and export trade, each committee member will enhance their understanding and insight through training and information exchange in order to raise the level of the industry as a whole.

12. access to and benefit sharing of digital sequence information (DSI) and other information under the Convention on Biological Diversity (in response to international discussions on ABS)

(1) Basic Policy

  • The CBD-ABS TF will work with other industry associations and the government to actively advocate, exchange information, and share information on the Nagoya Protocol to the Convention on Biological Diversity and the WHO pathogen sharing mechanism in order for the Japanese pharmaceutical industry to remain competitive in the international economic community, continue to develop, and fulfill its mission to continue to create innovation in drug discovery. To fulfill our mission to continue to create innovation, we will promote efforts to improve the environment by actively making recommendations, exchanging information, and disseminating information on the Convention on Biological Diversity, the Nagoya Protocol, and the WHO Pathogen Sharing Mechanism.

(2) Priority issues

Promote response to international discussions on Access and Benefit-Sharing (ABS) of Digital Sequence Information (DSI)
② Promote response to discussions on WHO pathogen sharing mechanism

3）Details of efforts to address priority issues

(1) Promote response to international discussions on access and benefit sharing (ABS) of digital sequence information (DSI)

  • Promote the promotion of international organizations, overseas government agencies, and society to resolve international issues related to the Convention on Biological Diversity and the Nagoya Protocol.
  • T-row will gather information on domestic and international trends, identify issues, consider solutions, and take action to resolve them, in cooperation with IFPMA, overseas pharmaceutical organizations (PhRMA, EFPIA, etc.), the International Chamber of Commerce (ICC), other industry organizations (JBA, etc.), and relevant ministries and agencies in Japan.
  • Work with IFPMA and overseas pharmaceutical organizations to address the issue of ABS in DSI as a particularly important issue.
  • Main specific activities are,
    　- Responding to international discussions on the Convention on Biological Diversity and Nagoya Protocol, especially on ABS of DSI (e.g., the multilateral benefit-sharing mechanism broadly agreed at COP16)
    　- Participation in IFPMA and the International Chamber of Commerce (ICC)
    　- Collaboration with overseas JPMA (PhRMA, EFPIA, etc.) and other industry associations (JBA, etc.)
    　- Collaboration with relevant ministries and agencies
    　- Support activities of the Japanese government, IFPMA, and the International Chamber of Commerce (ICC) in the CBD, etc.
    　- Surveys and research to resolve issues
    The following is a summary of the results.

(2) Promote response to discussions on WHO pathogen sharing mechanisms

  • Promote the promotion of the resolution of international issues related to pathogen sharing mechanisms, such as the WHO Pandemic Agreement, to international organizations, overseas government agencies, and society.
  • T-row will work with IFPMA, overseas pharmaceutical organizations (PhRMA, EFPIA, etc.), and relevant ministries and agencies in Japan to gather information on domestic and international trends, identify issues, consider solutions, and take action to resolve them.
  • Main specific activities are,
    　- Responding to international discussions on pathogen sharing mechanisms such as the WHO Pandemic Agreement
    　- Participation in IFPMA
    　- Collaboration with overseas JPMA (PhRMA, EFPIA, etc.)
    　- Collaboration with relevant ministries and agencies
    　- Support for activities of the Japanese government and IFPMA at WHO, etc.
    　- Surveys and research to resolve issues
    The following are some of the activities of IFPMA.

4) Other Issues and Initiatives

  • The CBD-ABS TF will build a system to respond promptly and appropriately to issues related to ABS and pathogen sharing in activities related to the promotion of innovation within the association and in cooperation with Europe, the U.S., and Asia, and promote the resolution of issues.
  • In addition, since there may be cases where the CBD-ABS TF alone cannot find the best solution, the TF will further strengthen cooperation with other committees within MISHOP to promote the resolution of issues.

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