Industry Policy Committee

Priority Issues

  1. Comprehensive Policy Review 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/loss
  4. Further enhancement and utilization of taxation system that promotes the creation of innovative new drugs and strengthens 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)

Initiatives

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

  • The committee will identify and analyze changes in the social environment and policy trends surrounding the R&D-based pharmaceutical industry, and conduct a comprehensive review, make recommendations and responses 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 taxation system, which are the cornerstones of industrial policy. In addition, the committee will also accurately respond to issues and urgent matters that cannot be addressed by the public-private dialogue and the Standing Committee, and organize the content and direction of advocacy.
  • In its deliberations and responses, the committee will collaborate with related organizations and utilize the research and survey functions of the Pharmaceutical and Industrial Policy Research Institute (PIPRI).

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

  • The basic policy is to achieve predictable compatibility between "an attractive Japanese market that enables a cyclical return on R&D investment and where the diverse value of new drugs is transparently and appropriately evaluated" and "the sustainability of universal health coverage" and to improve patient access to innovative new drugs, with the cooperation of the Policy Research Institute and related committees, and in collaboration with related organizations. We will continue to focus on the establishment and realization of an appropriate evaluation system for innovation in the NHI drug price reform and cost-effectiveness evaluation reform in FY2026, in cooperation with the Policy Research Institute, related committees, and related organizations.
  • From the standpoint of the R&D-oriented pharmaceutical industry, we will promote analysis and verification of the FY2024 system reform and the FY2025 NHI price revision, and will actively engage in public-private discussions based on the Pharmaceutical Manufacturers Association Policy Recommendations 2025, the Framework Policy 2024, and the Conceptual Meeting on Prompt Delivery of the Latest Pharmaceuticals to the Public by Enhancing Drug Discovery Capability, Interim Summary, Policy Targets and Timetable, etc. The measures realized by the reform in FY2024, such as the establishment of an additional fee for rapid introduction, review of the evaluation of pediatric drugs, addition of an item requirement for the additional fee for new drug creation, elimination of the "company index", and review of the treatment of similar products in the re-calculation of market expansion, are focused on the appropriate evaluation of innovative new drugs. The Government of Japan will continue to analyze and evaluate the impact on drug development, including the elimination of drug lag/loss, etc., focusing on measures related to the appropriate evaluation of innovative new drugs, while also keeping abreast of trends in the review of the pharmaceutical affairs system, etc. In addition, the committee will promote the review from the perspective of addressing social issues such as strengthening Japan's drug discovery capabilities, changing environment surrounding the pharmaceutical industry, strengthening international competitiveness, and increasing the transparency and reasonableness of drug price calculations. In particular, the committee will study specific proposals and develop recommendations for a new system that will enable appropriate evaluation of new drugs with high novelty and innovation potential.
  • With regard to cost-effectiveness evaluation, based on the verification of the operation and issues based on the FY2024 reform and the items related to cost-effectiveness evaluation in the "Kotta Policy 2024," we will further strengthen cooperation with the government, academia, and other related parties, and study the industry's approach and improvements for the FY2026 reform, We will issue timely and appropriate recommendations. In particular, the current system is biased toward reducing the prices of innovative new drugs, and we will work actively to make this an appropriate system that does not inhibit innovation by organizing our thinking, including the positioning and use of cost-effectiveness evaluation in the NHI drug pricing system, including the scope of the target and price adjustment.
  • 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, the committee will work on visualization of the value of pharmaceuticals and the contribution of the pharmaceutical industry, and will develop activities in cooperation with related committees and subcommittees.
  • To investigate and analyze trends in various systems related to medical care and pharmaceuticals, including the medical insurance system, and to study the industry's approach and necessary measures from the perspective of ensuring patients' access to medicines and the sustainability of the universal health insurance system, and to promote discussions and proposals with related parties.

3. promotion of efforts to eliminate drug lag/loss

  • Promote information sharing on the content and progress of efforts to eliminate drug lag/loss in related committees of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and the Policy Research Institute, and address various issues in cooperation with the government and other parties.

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

  • Examine the impact of the establishment of the Innovation Center Tax Credit and the revision of the R&D taxation system in the FY2024 tax reform, and prepare for the next revision request so that both taxation systems will function effectively as incentives for R&D investment and promote innovation.
  • Verify the use of the special R&D tax credit system by member companies and promote its active use.
  • Examine the impact of the R&D tax credit and the tax credit for innovation centers on the R&D investment decisions of member firms, and consider new taxation systems that will contribute to further promoting innovation and improving and strengthening domestic production and manufacturing systems.

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

  • As it is the starting year of the third phase of the Health and Medical Care Strategy (2025-2029), we will make a concerted effort to ensure the effectiveness of measures to support the creation of innovative new drugs, as outlined in the Drug Discovery Initiative Council, the third phase of the Health and Medical Care Strategy, and the Plan to Promote R&D in the Medical Field, etc., and to make them truly beneficial for the pharmaceutical industry. The Pharmaceutical Manufacturers Association of Japan (PMAJ) will make timely and accurate proposals to the relevant ministries and various committees, etc. In addition, the committee will also promote the "initiatives aimed at the creation of innovative new drugs from Japan," "development of R&D infrastructure," and "establishment of a medical data infrastructure and legal system to realize efficient, citizen- and patient-centered healthcare," as proposed in the Pharmaceutical Manufacturers Association of Japan Policy Proposal 2025, in cooperation with related committees and by lobbying related ministries, AMED and other relevant bodies. (3) Provide information based on policy recommendations.

6. strengthen efforts to promote the proper use of pharmaceuticals

  • Based on the policy recommendations, the committee will 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 and insurers' associations. The committee will promote the development and implementation of specific measures in cooperation with healthcare-related organizations, insurers' organizations, and others.

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

  • The committee will work closely with related committees to share information on efforts to combat infectious diseases and issues that need to be addressed in normal times and in the event of an outbreak of infectious diseases, and to examine measures necessary for the creation and stable supply of therapeutic drugs and vaccines.

8. promotion of initiatives related to economic security

  • The second Trump administration has come to power in the U.S., and the future of the international situation in terms of security and trade is becoming increasingly uncertain, as the U.S. government, under its "America First" policy, has made the return of manufacturing to the domestic market a pillar of its policy. In Germany, France, and Japan, coalition governments are being asked to manage difficult administrations, and each country is shifting to inward-looking commercial policies. In addition, geopolitical risks in East Asia are increasing, and for the pharmaceutical industry, it is necessary to watch global trends from an economic and security perspective, including supply chain resilience, advanced technology competition, and cybersecurity measures. The pharmaceutical industry needs to monitor global trends from an economic security perspective and take necessary actions, such as supply chain resilience, advanced technology competition, and cyber security measures. The Economic Security Task Force will collect and analyze relevant information, and if necessary, consider, coordinate, and respond to policies that need to be formulated by the industry, as well as conduct educational activities for member companies.

9. promotion of initiatives on intractable and rare diseases

  • Last fiscal year, in collaboration with the Undiagnosed Diseases Initiative (IRUD) and the Rare Diseases Consortium of Japan (RDCJ), we prepared a "Survey on the problems of healthcare professionals" (November 2024), which covers five areas (1. basic and applied research, 2. development and clinical trials, 3. diagnosis, 4. treatment and prognosis) of rare disease treatment and research from the healthcare professionals' perspective. Treatment and Prognosis Management, and Disease Awareness), and organized solutions and actions to be taken. In the future, we will consider making recommendations based on the results of the survey of healthcare professionals and promote activities in collaboration with various stakeholders involved in intractable and rare diseases, including patient groups, healthcare professionals, government, and academia, in order to resolve the issues identified in the survey so far.

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

  • Based on the policy recommendations of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and other relevant committees and subcommittees, the committee will formulate content that addresses short-term issues such as the response to the Framework Policy 2025 and medium- and long-term issues such as promoting understanding of the pharmaceutical industry among the public, and promote strategic advocacy activities in collaboration with the relevant 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.
  • Regarding the research public solicitation project launched in FY2023, follow up on the themes adopted in the first and second rounds of solicitation, and develop activities for the third round of solicitation. 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 by strengthening relationships with people in the pharmaceutical industry and academia.
  • To deepen the understanding of the pharmaceutical industry among the public and patients, the committee will formulate target-specific strategies for promoting understanding in cooperation with the Public Relations Committee, etc., and promote activities to shape public opinion through the use of a wide range of media.

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

(1) Early realization of the elimination of the fifth tariff on pharmaceuticals

Although the fifth round of tariff elimination work remains stalled, we will cooperate with relevant ministries and INTERCEPT, etc., and prepare a tariff elimination list for submission to the Diet to ensure a smooth resumption of the work when it is resumed.

2) Compliance with the Pharmaceutical Affairs Act and related laws and regulations: Continuation of surveys, information gathering activities, and educational activities, as well as coordination and cooperation with other organizations

We will continue to work in close cooperation and collaboration with related committees within the Pharmaceutical Manufacturers Association of Japan (PMAJ) and related industries and organizations to ensure compliance with and appropriate application of the Pharmaceutical Affairs Law and related laws and regulations.

(3) Responding to various trade issues: holding workshops, lectures, etc., and exchanging information among committee members

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. addressing access to digital sequence information (DSI) and benefit sharing under the Convention on Biological Diversity (ABS)

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.
  • To this end, we will collaborate with IFPMA, overseas pharmaceutical organizations (such as the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA)), the International Chamber of Commerce (ICC), other industry organizations (such as the Japan Bioindustry Association (JBA)), and relevant ministries and agencies in Japan to collect information on domestic and international trends Identify issues, consider solutions, and take action to resolve them.
  • Work with IFPMA and overseas pharmaceutical organizations to address the issue of ABS in DSI as a particularly important issue.
  • Major specific activities are as follows
    　- Responding to international discussions on the Convention on Biological Diversity and the Nagoya Protocol, especially on ABS of DSI (e.g., the multilateral benefit-sharing mechanism broadly agreed to at COP16)
    　- Participation in IFPMA and the International Chamber of Commerce (ICC)
    　- Collaboration with overseas pharmaceutical associations (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

(2) Promote response to World Health Organization (WHO) discussions on pathogen sharing mechanisms.

  • Promote the promotion of the resolution of international issues related to the WHO Pandemic Convention and other pathogen sharing mechanisms to international organizations, overseas government agencies, and society.
  • To this end, the IFPMA will work with IFPMA, overseas pharmaceutical organizations (PhRMA, EFPIA, etc.), and relevant domestic ministries and agencies to collect information on domestic and international trends, identify issues, study measures to resolve them, and take action toward their resolution.
  • The main specific activities are as follows
    　- Responding to international discussions on pathogen sharing mechanisms such as the WHO Pandemic Convention
    　- Participation in IFPMA
    　- Collaboration with overseas pharmaceutical organizations (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

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