Business Policy and Plan for FY2025

Japan Pharmaceutical Manufacturers Association, Inc.

Introduction

Government policy of "land of drug discovery" and "growth industry and key industry" and the objectives and business of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

At the Drug Discovery Ecosystem Summit held in July last year, the government stated that the most important measure is to improve Japan's drug discovery capabilities and promptly deliver the latest pharmaceutical products to the people of Japan, and that Japan is a "land of drug discovery" that can contribute to people around the world, and that the pharmaceutical industry is an important "growth industry" that can take advantage of Japan's scientific and technological capabilities, The pharmaceutical industry is an important "growth industry" that can take advantage of Japan's scientific and technological capabilities, and is positioned as an industry that should become a "core industry" responsible for Japan's future growth.

The Japan Pharmaceutical Manufacturers Association (JPMA) is an organization whose purpose is to improve the health and welfare of the people of Japan and the world through the sound development of drug discovery and the pharmaceutical industry, and whose members are Japanese pharmaceutical companies oriented toward research and development. In order to realize the future of Japan together with the government as indicated at the Drug Discovery Ecosystem Summit, our mission has become more and more important together with our member companies.
On the other hand, the road to making the pharmaceutical industry an industry that can further contribute to the people of Japan and the world and that can play a role in Japan's future growth is not a smooth one, as the government has decided to implement a mid-year revision of drug prices in FY2025.

Industry Vision, Policy Recommendations, and Business Policy and Business Plan

In light of the major changes in the environment both domestically and internationally, the Pharmaceutical Manufacturers Association of Japan (PMAJ) has revised the PMAJ Industrial Vision 2025 and announced the PMAJ Industrial Vision 2035.
In addition, the Japan Pharmaceutical Manufacturers Association (JPMA) Constitution (hereinafter referred to as the "Constitution") stipulates that the Association's business shall include: 1. recommendations for the development of infrastructure necessary for the promotion of pharmaceutical R&D; 2. recommendations regarding social security systems, including medical insurance systems; and 3. recommendations necessary for the R&D-oriented pharmaceutical industry, and based on these recommendations, the Association has published Policy Proposal The Association has published "2025.
Therefore, the business policy and business plan for FY2025 will be formulated based on the objectives and projects stipulated in the Constitution of the Association, as well as based on the policy for initiatives indicated in Policy Proposal 2025 as a means of realizing the Pharmaceutical Manufacturers Association of Japan Industry Vision 2035.

1. business policy

The business policy for FY2025 shall be established in accordance with the pillar construction of the Pharmaceutical Manufacturers Association of Japan Industry Vision 2035, and in addition to the above-mentioned constitution, the following projects stipulated in the constitution shall be actively addressed as an integral part of the plan.

  • Ensure free and fair corporate activities and uplift corporate ethics
  • Ensure the quality, efficacy, and safety of pharmaceuticals and promote their proper use
  • Cooperation with relevant international organizations and groups, and planning and promotion of international cooperation and support activities
  • Promoting dialogue with medical consumers and consumers, and raising awareness and stimulating fair public opinion about the pharmaceutical industry
  • Appropriate response to environmental issues, etc.

FY2025 is the first year of the Pharmaceutical Manufacturers Association of Japan (PMAJ) Industry Vision 2035, etc., as well as the year of revision of medical service fees and research and development taxation, and it is necessary to take necessary actions including the revision of the Pharmaceuticals and Medical Devices Law and other systems in the ordinary Diet session, and the AMED, which will start a new medium- to long-term planning period based on the Third Health and Medical Strategy, etc. The "Japan for the World" initiative will also be a key element of the "Japan for the World" initiative.
In addition, the government's policy of making Japan a "land of drug discovery" that can contribute to the people of the world and the current environment, such as the drug price system that lacks predictability and the social security system that relies on drug price reductions, will be taken into account to deepen discussion on the state of innovation and the industry.

(1) Contribute to the economic growth of Japan as well as to the extension of healthy life expectancy by continuously creating innovations

Continuously create innovative new drugs through rapid introduction and application of cutting-edge science and technology

  • Continue to introduce cutting-edge science and technology, including bioengineering, AI (Artificial Intelligence), DX (Digital Transformation), and new modalities (including Digital Therapeutics), in all aspects of development, manufacturing, post-marketing measures, etc. We will work on the introduction of cutting-edge science and technology.

Establish an environmental infrastructure for drug discovery

  • In addition to conventional technologies useful for pharmaceutical research, we will broaden our scope to include next-generation synchrotron radiation, high-performance computer systems, and other technologies that could become Japan's strengths, as well as budding technologies such as nanotechnology and quantum computers, and promote their utilization in industry and academia.
  • In the Whole Genome Analysis Project, which will be launched this fiscal year, we will make efforts to build a highly convenient and fulfilling utilization system by participating in the Project Implementation Organization Preparation Office and consortiums, and accelerate and promote the project, including making proposals for necessary environmental improvements.
  • In light of the legal revision to promote the utilization of public DB by 2025, work toward further establishment of health and medical data infrastructure, development of legal systems, and standardization of data in order to further promote efficient and effective drug discovery.

Contribute to the development of highly skilled human resources in Japan toward Japan as a science and technology-driven nation

  • Continue to lead open innovation and strive for advancement of knowledge including industry and academia.
  • Actively commit to the development of new drug discovery science education programs that transcend the boundaries of conventional pharmaceutical knowledge.
  • We will propose "support for the development of human resources for biomanufacturing," "support for biomanufacturing education for students," and "support for the activities of the Biologics Research and Training Center (BCRET)," and promote the formulation of a human resource development plan.

Promote co-creation involving patients and citizens to realize patient/citizen-participatory drug discovery

  • Based on the Joint Declaration of the Pharmaceutical Visionary Conference 2024, we will accelerate our commitment to "Co-Creation" to promote the participation of patients and citizens at all stages, from non-clinical to post-marketing, as well as clinical trials.
  • Based on the "Consensus Framework for Ethical Collaboration in Japan," we will promote the creation of opportunities for collaboration between industry, academia, and government through the secretariat operation of the "Society for the Creation of an Accessible Society in Clinical Trials" (commonly known as the "Creation Society") and the "Pharmaceutical Visionary Council" and other activities.
  • In clinical trials, efforts will be made to realize decentralized clinical trials (DCT), improve the efficiency of information disclosure, and ensure that clinical trial information disclosed by pharmaceutical companies is written in a manner that is easy for patients and the public to understand.
  • With regard to intractable and rare diseases, we have held symposiums on Rare Disease Day and conducted a "Survey on Problems of Medical Professionals in Rare Diseases," and we will continue our efforts in collaboration with related organizations.

Expand the scope of life science-related industries as a whole by building and developing a drug discovery ecosystem

  • We will make every effort to ensure that the opinions of the industry, which is rich in knowledge of drug discovery and practical application, are reflected in the public-private sector conferences scheduled for this year, and that an ecosystem befitting the "Land of Drug Discovery" takes root.
  • In order for the Japan Agency for Medical Research and Development (AMED), which begins its third mid- to long-term plan period this fiscal year, to fulfill its expected role as the center of R&D support, we will seek and cooperate with the AMED to steadily implement reforms, such as eliminating vertical division of projects, flexibly promoting basic research projects, and integrating projects that promote practical application, based on the issues identified before the plan was formulated and the direction of solutions. In this way, we will seek and cooperate with the implementation of reforms to ensure that stove-piping of projects is eliminated, basic research projects are promoted in a flexible manner, and projects that promote practical application are promoted in an integrated manner.
  • The many drug discovery and biotechnology clusters that exist in Japan should be strengthened, and the "people, goods, and money" that are dispersed throughout the country should be connected.

Contribute to the health of people around the world by promoting the global development of innovative new drugs

  • We will support the activities of member companies in cooperation with governments, industry associations, and diplomatic missions abroad.
  • The Council will collect information from various countries, promote overseas penetration and harmonization of Japanese pharmaceutical regulations, promote international cooperation among regulatory authorities such as the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperative Scheme (PIC/S), promote international collaboration to achieve mutual recognition of GCP, and strengthen cooperation in the simplified review system based on Japanese pharmaceutical approvals.
  • Promote solutions to regulatory issues in each country and strengthen advocacy by strengthening public-private partnerships through the Asia Partnership Conference of Pharmaceutical Associations (APAC), bilateral meetings and symposiums.
  • Share important issues surrounding the pharmaceutical business through IFPMA, Biopharmaceutical CEO Roundtable (BCR), etc., and strengthen multilateral advocacy activities including the unique activities of the Pharmaceutical Association of Japan (PAPJ) in cooperation with IFPMA, etc. Strengthen multilateral advocacy activities, including the activities of the Pharmaceutical Manufacturers Association of Japan (PMAJ), in cooperation with IFPMA and other organizations.
  • We will take appropriate measures to ensure that international discussions at the Convention on Biological Diversity (CBD) and the World Health Organization (WHO) on access to genetic resources and their information and benefit sharing do not impede research and development activities that contribute to patients and medical care through the utilization of genetic resources.
  • In the ICH, we will continue activities appropriate to our role as one of the founding industry organizations, including the development and strengthening of a system for examining new topics, etc.

Respond appropriately to domestic pharmaceutical affairs-related policies

  • Based on the agreement reached at the "Study Group on the Drug Regulation System to Enhance Drug Discovery Capability and Ensure Stable Supply" and the system review in the revision of the Pharmaceuticals and Medical Devices Law submitted to the ordinary Diet session, make recommendations for further streamlining the review and investigation process, re-evaluation of existing drug regulations, and so on.
  • Promote GCP renovation based on ICH E6 (R3), including the use of Real World Data (RWD), etc., for domestic implementation in clinical trials and clinical research.
  • Conduct research and make recommendations on the pharmaceutical regulatory environment that responds to technological advances, such as software that supports new modalities and health and medical data.

Respond to the taxation system, intellectual property system, etc.

  • Address the FY2026 tax reform request to review the R&D taxation system so that innovation creation is promoted.
  • We will continue to examine the data protection system and other systems for the pharmaceutical industry, which requires long-term R&D and large R&D investments, and promote understanding of international protection of intellectual property rights, which improves the investment environment and supports continued innovation creation in international public opinion, where restrictions on intellectual property rights are sometimes discussed. We will continue to promote understanding of international protection of intellectual property rights to improve the investment environment and to support continued innovation creation.

Contribute to Japan's economic growth as a key industry by expanding exports and strengthening tax-bearing capacity

  • In addition to playing a role in the pharmaceutical industry, which is positioned as a growth and key industry, we will promote and disseminate research and studies on the contribution of the pharmaceutical industry to economic growth, etc.

(2) Contribute to health security by promptly delivering innovative new drugs to the public

Pursue the value of innovation and build an attractive Japanese market in order to continuously produce and deliver innovative new drugs.

  • Toward the reform of the NHI drug price system in FY2026, we will work to establish and realize an appropriate evaluation mechanism for innovation (e.g., improving the process of evaluating the value of new drugs, evaluating the various values of pharmaceutical products, etc.).
  • Examine operations and issues based on the FY2024 NHI drug price system reform, etc., and promote studies and efforts for improvement toward the next system reform, such as cost-effectiveness evaluation.
  • Continue to actively express opinions and requests for improvement as a pharmaceutical association in cooperation with the Japan Federation of Pharmaceutical Manufacturers & Associations (JFPMA), the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and other organizations.

Propose a social security system that allows for early and stable access to the "latest" and "global standard" treatments in the future.

  • In order to build a sustainable social security system, we will appeal to the government for benefits, burdens, and financial management that does not rely on drug price reductions.
  • We will address the revision of the NHI drug price system in FY2026, taking into account its verification, so that the direction of the FY2024 NHI drug price system reform, which aims to appropriately evaluate innovations of innovative new drugs to strengthen Japan's drug discovery capability and eliminate drug lag/drug loss, will be inherited.
  • In order to eliminate drug lag/loss, it is important to improve the drug discovery environment in Japan and to evaluate innovations appropriately, and we will continue to appeal to the government.
  • We will provide information on the Japanese market and pharmaceutical regulations to overseas start-up companies through the PMDA U.S. office, which was established last year, in order to promote the launch of new products in Japan.
  • As for drug losses that are emerging, we will update information and conduct ongoing surveys, and respond appropriately to requests for development through the "Review Committee on Unapproved and Off-label Drugs of High Medical Need" and other means.

Participate in discussions with the national government, insurers, and medical professionals, and play a role in ensuring the health security of Japan and its people.

  • Actively participate in government councils, etc.
  • In order to ensure the supply chain and stable supply of pharmaceuticals, we will promote initiatives and information sharing with our members, including from the perspective of economic security in response to heightened geopolitical risks.

(3) Ensure ethics and transparency, and become an industry trusted by society

Participate in overcoming social problems, including the achievement of SDG Goal 3 "Health and Welfare for All," and in addressing environmental issues such as climate change.

  • Continue to promote universal health coverage and promote activities to solve global health issues in collaboration with various stakeholders.
  • Promote research and development on drug-resistant (AMR) infections, which are causing an increasing number of deaths worldwide, and make recommendations to governments on pull-type incentives, etc.
  • In order to prepare for the next pandemic of infectious diseases, we will strengthen the foundation of the vaccine industry and actively make proposals for the revision of the "Basic Plan on Immunization" that is currently under discussion, with a view to its renewal.
  • We will continue to take appropriate measures to address environmental issues, such as a carbon neutral plan to prevent global warming and a commitment to the formation of a recycling-oriented society.

Conducting activities with high ethical standards, behavioral standards, and transparency in order to earn the trust of society.

  • Promote the execution of corporate activities with high ethics and transparency in accordance with the spirit of the Pharmaceutical Manufacturers Association Code of Practice, including inspections during the "Code Understanding Promotion Month.
  • Continue to implement initiatives for proper drug transactions in cooperation with related parties based on the "Guidelines to be Followed by Distribution Personnel to Improve Distribution of Ethical Drugs".

Contribute to improving public literacy in health, medicine, and science, in cooperation with related parties, to ensure the proper use of pharmaceuticals by the public

  • In addition to making use of the introductory materials on the drug development process prepared for patients and the public, we will furthermore carefully disseminate to patients and the public information on post-marketing corporate efforts and the safety and usefulness of drugs obtained through such efforts.
  • In cooperation with related organizations, contribute to the improvement of public literacy by utilizing events such as "Drug and Health Week" and pamphlets such as "Knowledge of Drugs You Need to Know", while also taking feedback into consideration.
  • Examine how drug information should be provided to the public, etc., and study and make recommendations on rules to realize information provision activities that meet patient needs.
  • Continue to implement activities such as dissemination and awareness-raising activities for the proper use of antimicrobial agents and the optimal use of high-cost drugs.
  • Continue to conduct educational activities for a wide range of stakeholders as a measure against polypharmacy.

Establishment of a system to continue to provide high quality and stable supply of pharmaceuticals

  • Improve quality in quality control by utilizing digital technology, etc.
  • Continue to conduct surveys and studies for stable supply, including securing the supply chain.
  • Continue to address the "2024 problem" related to logistics and ensure a stable supply of pharmaceuticals.

Continuously communicate the social significance of pharmaceuticals and the pharmaceutical industry to the public and encourage the next generation of children and young people to be active in the pharmaceutical industry, academia, and the medical field.

  • Actively engage in advocacy activities, including those in academia, to gain understanding and support for the pharmaceutical industry's efforts to appropriately respond to the medical needs of the public.
  • Conduct symposiums and seminars in collaboration with various organizations, such as the Pharmaceutical Manufacturers Association Forum and the Pharmaceutical Manufacturers Association Seminar.
  • Support the complete renovation of the "Kusurium," a pharmaceutical exhibition room at the Science Museum (in Tokyo's "Kitanomaru Park"), where the majority of visitors are young people.
  • Continue to provide opportunities to convey the overall picture and appeal of biopharmaceutical manufacturing and CMC R&D to students in school as an opportunity for them to develop an interest in the field as a career path.

2. business plan

In addition to constant implementation of measures to ensure transparency and fairness in corporate activities, etc., we will implement activities such as making proposals to the government in a timely and appropriate manner in accordance with the timing of deliberations and decisions by the government, etc. on legislation, budgets, policy on bone fides, NHI drug price standards, etc.
From the viewpoint of ensuring mobility and flexibility in light of rapidly changing domestic and international circumstances, as mentioned above, specific business plans shall be left to the implementation plans of each committee and the Pharmaceutical Industry Research Institute as in the past. When necessary, the chairperson of each committee is to report on the activities of the committee to the Executive Committee, etc., and based on the opinions of the Committee, necessary changes, etc., shall be made to the implementation plan of each committee.
In order to realize the objectives of the Association and the Pharmaceutical Manufacturers Association of Japan Industry Vision 2035, etc., all committees are expected to exercise their expertise from their respective standpoints and pursue their activities in a systematic manner.

(1) Contribute to the economic growth of Japan as well as to the extension of healthy life expectancy by continuously creating innovations

  • Rapid introduction of cutting-edge technologies, establishment of drug discovery environment infrastructure and drug discovery ecosystem

    Research and Development Committee, Drug Evaluation Committee, Quality Committee, Biopharmaceutical Committee, Industrial Policy Committee, Pharmaceutical Affairs Committee

  • Promote co-creation involving patients and citizens

    Patient Organization Collaboration Promotion Committee, Drug Evaluation Committee, Industrial Policy Committee

  • Responding to global expansion

    International Committee, APAC Project, ICH Project

  • Responding to domestic pharmaceutical affairs-related policies

    Regulatory Affairs Committee

  • Respond to the taxation system, intellectual property system, etc.

    Industrial Policy Committee, Intellectual Property Committee

(2) Contribute to health security by promptly delivering innovative new drugs to the public

  • Propose a market and social security system in Japan that will enable the continuous development and delivery of innovative new drugs, the rapid delivery of the "latest" treatments, and the stable provision of "global standard" treatments for the future.

    Industrial Policy Committee, Pharmaceutical and Industrial Policy Institute

(3) Ensure ethics and transparency, and become an industry trusted by society

  • Participation in overcoming social problems and addressing environmental issues such as climate change, including the achievement of SDG Goal 3 "Health and Welfare for All

    International Committee, Environmental Issues Study Group, Biopharmaceutical Committee

  • Conducting activities with high ethical standards, behavioral standards, and transparency

    Code Compliance Promotion Committee, Product Information Summary Review Committee, Distribution Appropriateness Committee

  • Provide and disseminate information on medicine and health, including the proper use of pharmaceuticals

    Public Relations Committee, Drug Evaluation Committee, Pharmaceutical Consultation and Response Study Group, Industrial Policy Committee

  • Establishment of a system to continue to provide high quality and stable supply of pharmaceuticals

    Quality Committee, Distribution Optimization Committee, Pharmaceutical Affairs Committee

  • Communicating the social significance of pharmaceuticals and the pharmaceutical industry to children and young people

    Public Relations Committee, Industrial Policy Committee, Biopharmaceuticals Committee

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