International Affairs Committee

Priority Issues

  1. International Expansion: Improvement of the environment in Asian, European, and U.S. markets through public-private collaboration and support for member companies' activities
  2. International Collaboration: Activities to solve bilateral/multilateral issues in collaboration with various stakeholders such as governments and pharmaceutical organizations around the world
  3. International Contribution: Contributing to global healthcare by delivering innovative medicines developed in Japan and aiming to improve access to healthcare.

The main tasks of each subcommittee based on the above basic policy are as follows

[A] Asia Subcommittee

  1. Promotion of Universal Health Coverage (UHC)
  2. Promoting international harmonization of pharmaceutical regulations and improving the efficiency, transparency, and predictability of regulatory review, and improving the clinical trial environment in Asia
  3. Ensuring rapid and sustainable access to innovative medicines
  4. Identify and share policy and regulatory trends related to pharmaceutical affairs, reimbursement, intellectual property, etc. with members
  5. Strengthen collaboration with the Japanese government, diplomatic missions abroad, international organizations, research institutions, and local Japanese and R&D-based pharmaceutical organizations

[B] Europe and North America Subcommittee

  1. Identification of issues to improve the business environment in the US and European markets, and lobbying of relevant ministries, agencies, and diplomatic missions overseas to resolve these issues, as well as collaboration with key industry associations in the US and Europe
  2. Contribute to the promotion of activities within JPMA through a hub role, including strengthening cooperation with other committees and subcommittees that are relevant stakeholders in major countries in Europe and the U.S.

[C] Global Health Subcommittee

  1. Strengthening collaboration within the JPMA in addressing multilateral issues, enhancing the ability to communicate to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and multilateral advocacy to multi-stakeholders
  2. Contribution to improving access to medicines in low- and middle-income countries
  3. Strengthening efforts to combat infectious diseases

Priority Tasks to be addressed

[A] Asia Subcommittee

The following priority countries and regions will be targeted for issue resolution.

  • China, Korea, Taiwan, ASEAN (Thailand, Indonesia, Malaysia, Vietnam, Singapore, Philippines), India

1) Promotion of Universal Health Coverage (UHC)

  1. Activation of aUHC (Asia UHC) Group: Through the aUHC Group, discuss cross-Asian access issues and contribute to the realization of UHC in each country/region by promoting measures including the utilization of the channels of the JPMA APAC Project.

2) Promote international harmonization of pharmaceutical regulations, improve efficiency, transparency, and predictability of regulatory review, and improve the clinical trial environment in Asia.

  1. Shift to industry-led symposia: Promote industry-led activities (e.g., in collaboration with local JPMAs) and invite experts from the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (NIH), etc., as appropriate to the topic, in order to promote more practical and strategic regulatory harmonization. In addition, the PMDA will strengthen its advocacy by providing support to the Asian Training Center (ATC), PMDA Asia Office, and others.
  2. Promote awareness and utilization of basic information on the bilateral regulatory framework (Reliance), including reference country systems, and the latest information collected through continuous updates to member companies.
  3. Identify issues that hinder smooth implementation of clinical trials and regulatory harmonization in Asia, and seek solutions through collaboration with the MHLW, PMDA, and research institutions.

(3) Ensuring prompt and sustainable access to innovative drugs

  1. Identify trends in related systems such as insurance, drug pricing, and medical technology assessment through collaboration with regional pharmaceutical organizations in each country.
  2. Develop advocacy plans for innovative drugs to improve their proper evaluation, timeliness, transparency, and predictability.
  3. Study and promote issues and solutions in each country/region through bilateral meetings (symposiums) led by industry associations, etc.

4) Identify and share policy and regulatory trends related to pharmaceutical affairs, reimbursement, intellectual property, etc. with members

  1. Share policy and regulatory trends and best practices in key countries/regions with stakeholders inside and outside the committee.
  2. To gain a comprehensive understanding of information related to regulatory affairs, insurance, drug pricing, intellectual property, etc. in each country/region through participation in the JPMA's APAC Project and PMRE Task Force.

5) Strengthen collaboration with the Japanese government, diplomatic missions abroad, international organizations, research institutions, and local Japanese and R&D-based pharmaceutical organizations

  1. Strengthen collaboration with the Japanese government, including diplomatic missions abroad, the Japan External Trade Organization Act (JETRO), international organizations such as the World Health Organization (WHO), and domestic and foreign research institutions, including ATLAS and other projects to establish an Asian international joint clinical trials network.
  2. Strengthen collaboration with Japanese and R&D-based pharmaceutical organizations in Asian countries and regions, as well as global pharmaceutical organizations such as the Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), IFPMA, etc., depending on the policy theme.

[B] Europe and North America Subcommittee

(1) Work to improve the business environment in the US and European markets, promote the maintenance and strengthening of partnerships with pharmaceutical associations and governments in the US, Europe, and other countries, and accumulate intelligence on the latest information from the US and Europe, etc.

  1. Identify key issues and consider solutions: hold regular meetings with PhRMA, EFPIA, the Association of the British Pharmaceutical Industry (ABPI), the German Association of the Research-based Pharmaceutical Industry (vfa), the French Association of the Pharmaceutical Industry (leem), etc., as well as with local Japanese associations such as the Japanese Pharmaceutical Group in the UK and the Japanese Business Council in Europe (JBCE). Identify and resolve policy, trade, tariff, regulatory, pricing, and reimbursement issues in major Western countries through collaboration with local Japanese organizations such as the Japanese Pharmaceutical Group in the UK and the Japanese Business Council in Europe (JBCE), interaction with JETRO New York secondees, and information exchange with the Japanese government, embassies in Japan, and diplomatic missions abroad.
  2. Collaboration with domestic and foreign stakeholders for advocacy activities: With the aim of contributing to the health of people around the world, promote advocacy activities to European and US governments, the Japanese government and relevant ministries and agencies, etc., in collaboration with European and US organizations, etc., to resolve issues for the promotion of innovative new drugs in the US and Europe.
  3. Keep abreast of the latest information from Europe and the U.S.: Collect and analyze the latest information from Europe and the U.S. (government policies and major medical policies on healthcare, pharmaceutical regulations, drug pricing and reimbursement systems, systems for cooperation with patient groups, etc.) through planning and implementation of regular and active information exchange meetings with external speakers and related organizations, and share this information with member companies.
  4. To share the intelligence obtained through the above activities from the US and European subcommittees with relevant committees within the JPMA, such as the Pharmaceutical Industrial Policy Committee, and contribute to the JPMA's formulation of policy recommendations to the Japanese government.

2) Collaboration within JPMA (in a hub role)

  1. To contribute to the development of the JPMA's policy recommendations to the Japanese government by utilizing its hub role between industry associations, embassies, JETRO, PMDA Washington D.C. office, and other committees of the JPMA and by providing the intelligence of the US/Europe subcommittee to the above stakeholders. Contribute to strengthening the Japanese government's capacity to formulate industrial policies by providing intelligence from the European and US subcommittees to the above stakeholders.

[C] Global Health Subcommittee

1) Strengthen collaboration within the JPMA in addressing multilateral issues, enhance ability to communicate to IFPMA, and multilateral advocacy to multi-stakeholders

  1. Participate in the activities and discussions of IFPMA's relevant committees to strengthen JPMA's ability to disseminate information. (Collaborate with the Pharmaceutical Industrial Policy Committee, Intellectual Property Committee, Vaccine Practitioners Committee, etc.).
    Clarify the JPMA's activity policy on multilateral issues through collaboration with related JPMA committees, and strengthen the IFPMA's ability to disseminate information.
  2. Aiming to maintain the pharmaceutical industry's business model based on intellectual property and to promote innovation and improve access to medicines and vaccines in response to global issues such as the Convention on Pandemics, Convention on Biological Diversity, and the TRIPS Waiver, we will utilize opportunities at various international conferences (WHA, G7/20, UNGA, etc.) to discuss the following issues. Lobby the Japanese government, the Permanent Missions of Japan to other stakeholders, including the Government of Japan, the Permanent Missions of Japan Abroad, and others.
    Lobby the Japanese government, the Permanent Mission of Japan to other countries, IFPMA, and other stakeholders to reflect JPMA's views in the negotiation process of international treaties such as the Convention on Pandemics, Convention on Biological Diversity, and the TRIPS Agreement (including providing knowledge).
  3. Lobby (make policy recommendations) to the Government of Japan, the Permanent Missions of Japan to other countries, the Keidanren (Japan Business Federation), the OECD, and other stakeholders, utilizing policy discussion forums (G7/20, B7/20, UNGA, etc.) on multilateral issues, Contribute to the continuous creation of innovation and improved access by ensuring and improving a sustainable business environment, reducing future business risks, and increasing industry value.
  4. To gain understanding and trust in the industry by communicating the global contribution of Japan's R&D-based pharmaceutical industry based on evidence.
    To gain the understanding and trust of the industry by communicating the global contributions of Japan's R&D-based pharmaceutical industry based on evidence through side events at international conferences where many policy makers in international health gather (World Health Assembly (WHA), United Nations Assembly (UNGA), etc.).

2) Contribution to improving access to medicines in low- and middle-income countries

  1. Positioning this as the final year of the second phase of the training program, the project will strengthen advocacy both in Japan and Vietnam, and support Bac Mai Hospital (Vietnam) to establish an independent management system for the preparation of anticancer drugs and guidance on anticancer drug administration. In collaboration with the Japanese and Vietnamese governments, we will consider a system in which the results of this project can be utilized through public mechanisms, etc.

3) Strengthening efforts to combat infectious diseases

  1. Collaborate with international organizations and associations to build an ecosystem from drug discovery promotion to access to infectious diseases, which is an important issue for global health, and contribute to the solution of the issue.
  2. Raise awareness of the threat of infectious diseases including drug-resistant (AMR) and the need for countermeasures, and contribute to appropriate pandemic preparedness and response by understanding the status of domestic and international efforts to ensure Medical Countermeasures (MCM) and participating in discussions.
    Promote industry-academia-government collaboration to realize ideal domestic push and pull type incentive systems that contribute to the promotion of research and development of AMR drugs.
  3. Promote collaboration with the Japan Agency for Medical Research and Development (AMED) to build a community to promote efforts in drug discovery for infectious diseases, including AMR, in industry, academia, and government, as well as to conduct activities that will contribute to the development of young researchers.
  4. Continue public awareness activities on the proper use of antimicrobial agents, and disseminate these activities through the JPMA website and other means.
  5. To look at the three major infectious diseases and NTDs from a bird's eye view up to drug development and delivery, and work together with domestic and international stakeholders to make contributions, while aiming to build a highly sustainable access system for the pharmaceutical sector and promote disease awareness and understanding in the long run.

[D] Cross-committee and cross-subcommittee initiatives

The committee will strengthen cooperation with other committees in all of the above areas, as well as undertake cross-subcommittee initiatives as appropriate.

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