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 communication to 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 symposiums: Promote industry-led activities (e.g., in collaboration with local JPMA organizations) and invite experts from MHLW, PMDA, etc., depending on the topic, to promote more practical and strategic regulatory harmonization. In addition, strengthen advocacy through the Asian Training Center (ATC), PMDA Asia Office, etc.
  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. To identify issues that may be obstacles to smooth implementation of clinical trials and regulatory harmonization in Asia, and to seek solutions through collaboration with the MHLW, PMDA, and research institutes, etc.

(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, international organizations such as JETRO, WHO, etc., and domestic and foreign research institutions including ATLAS and other projects to establish an Asian international joint clinical trial 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 PhRMA, 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: Regular meetings with PhRMA, EFPIA, ABPI, vfa, leem, etc., as well as with the Japanese Pharmaceutical Group in the U.K. and the Japanese Business Council in Europe (JBCE). Pharmaceutical Group (UK), Japanese Business Council in Europe (JBCE) and other local Japanese organizations, exchanges with JETRO New York secondees, and information exchange with the Japanese government, embassies in Japan, and diplomatic missions abroad. Identify and work toward resolution of policy, trade, tariff, drug pricing, and reimbursement issues in major Western countries.
  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. Grasp 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 lecturers 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 the relevant committees of IFPMA to strengthen the JPMA's ability to disseminate information. (Collaboration with the Pharmaceutical Industrial Policy Committee, Intellectual Property Committee, Vaccine Practitioners Committee, etc.)
    Clarify activity policies on multilateral issues through collaboration with JPMA related committees and strengthen the IFPMA's ability to disseminate information.
  2. Aiming to maintain the business model of the pharmaceutical industry based on IP 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 TRIPS Waiver, utilize opportunities at international conferences (WHA, G7/20, UNGA, etc.). 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 Abroad, IFPMA, and other stakeholders to reflect the JPMA's views in the process of negotiating international treaties such as the Convention on Pandemics, Convention on Biological Diversity, and the TRIPS Agreement. (including provision of knowledge)
  3. Lobby (make policy recommendations) to the Government of Japan, the Permanent Missions of Japan to other countries, Keidanren, OECD, and other stakeholders by utilizing policy forums (G7/20, B7/20, UNGA, etc.) on multilateral issues to ensure and improve a sustainable business environment, reduce future business risks, and increase industrial value. 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 contributions of Japan's R&D-based pharmaceutical industry based on evidence.
    To gain understanding and trust of the industry by communicating the global contribution of Japan's R&D-based pharmaceutical industry based on evidence through side events at international conferences (WHA, UNGA, etc.) where many policy makers involved in international health gather.

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, strengthen advocacy both in Japan and Vietnam, and support the development of an independent management system for anticancer drug preparation and anticancer drug administration guidance by the Bac Mai Hospital. In collaboration with the Japanese and Vietnamese governments, a system to utilize the results of this project through public mechanisms, etc., will be considered.

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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