Topics Held regular meeting with the European Federation of Pharmaceutical Industries and Associations (EFPIA).

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The European and American Subcommittees of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) hold annual meetings with the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Association of the British Pharmaceutical Industry (ABPI), the French Pharmaceutical Manufacturers Association (Leem), and the German Association of Research-based Pharmaceutical Industries (vfa) as part of activities to cooperate with European and American governments and pharmaceutical organizations and to resolve international issues. The meeting is held every year. Recently, the regular meeting with EFPIA was held on November 25, 2022 in a hybrid face-to-face and online format; we hold regular meetings with EFPIA twice a year, and this was the second meeting in FY2022. A total of nearly 30 people from both sides attended the meeting, and a lively exchange of ideas took place. A summary of the meeting is reported below.

Mr. Koen Berden, Executive Director of International Affairs, EFPIA, opened the meeting with a speech, in which he noted the significance of this meeting, which started several years ago, to confirm and discuss trends in each country. Mr. Tatsuya Ito, Chairperson of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), expressed his pleasure at the first face-to-face meeting in a long time, his week-long tour that reaffirmed his appreciation of the event, and his expectations for the continued discussions at this meeting.

The session focused on three themes regarding the opportunities and risks of pharmaceutical regulation in the European Union (EU): the importance of intellectual property, the regulatory framework, and enhanced access. He also introduced "the European Access Portal" and "a Shared Equity Based Tiered Pricing" as EFPIA's efforts to address the issues of access to medicines.

In this session, information was shared on "the current situation and recognition of issues surrounding the pharmaceutical industry," "Kotto Policy 2022 and its impact on the pharmaceutical industry," "discussions in the expert panel of the MHLW, the NHI price revision for FY2023, and the status of future system reform" in Japan. During the discussion, questions were asked about the industry's response to the expert panel and the Central Social Insurance Medical Council (Chuikyo), to which the Pharmaceutical Manufacturers Association responded.

During this session, EFPIA introduced EFPIA's concept and initiatives on patient engagement. The Patient Think Tank, which was established as a forum for patient groups and industry associations to exchange ideas and build trust on topics important to patients and the pharmaceutical industry, the establishment of an award system for collaborative projects between industry and patient groups, and the Through various collaborative projects, the need for patients to better understand the pharmaceutical industry and to collaborate with it in innovative ways has become apparent, and activities using simulation models are beginning to be implemented.

The Pharmaceutical Manufacturers Association of Japan (PMAJ) provided an overview of the organization of the PMAJ's Committee for Promotion of Collaboration with Patient Organizations and its recent activities, as well as two guidelines on collaboration and transparency with patient organizations, which were revised in May 2022. He shared the background of the establishment of the Advisory Board to share and resolve issues toward the realization of patient-participatory medicine, as well as examples of specific activities such as patient group seminars, implementation of patient group surveys, and collaboration with other committees. The background of the guideline formulation was also introduced, as well as the revisions made to the guideline.

In the discussion, the Pharmaceutical Manufacturers Association of Japan (PMAJ) asked questions about the purpose and expected results of the EFPIA simulation model launch and the method of exchanging opinions in EFPIA, which has members from various countries, to which EFPIA provided specific answers. The Pharmaceutical Manufacturers Association of Japan (PMAJ) responded to questions about specific practices related to participatory medicine and how to involve patients in the approach to all stakeholders.

During this session, the joint recommendations of the Pharmaceutical Manufacturers Association and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) on the Health Agenda of the G7 Hiroshima Summit 2023 were introduced. The recommendations are to achieve "more resilient, equitable, and sustainable health systems" and "sustainable investment in innovation" in order to further promote innovation and access to medicines and sustain them in contingency situations, "Achieving Sustainable Universal Health Coverage (UHC) He introduced the three main pillars of UHC, namely, "realization of UHC," "preparedness for the next pandemic," and "addressing drug resistance (AMR).

In this session, the Pharmaceutical Manufacturers Association of Japan (PMAJ) introduced the challenges in promoting the utilization of health data in Japan, as well as the efforts of the government and PMAJ. Detailed explanations were given on the status of digitization of health data in Japan, health data available to pharmaceutical companies, the government's efforts to promote digital transformation (DX) in healthcare based on the Kotta Policy 2022, and policy recommendations made by the Pharmaceutical Manufacturers Association to the government. EFPIA also introduced the European Health Data Space (EHDS), a framework for the establishment and utilization of European health data infrastructure announced in May 2022, as well as EFPIA's efforts toward the operation of the EHDS. The discussion was led by the Pharmaceutical Manufacturers Association of Japan (PMAJ). In the discussion, the Pharmaceutical Manufacturers Association of Japan (PMAJ) asked about the prospects for the use of EHDS data, and EFPIA responded that after the implementation in 2024, the first priority will be to build the infrastructure for primary use in healthcare, and that it is expected to take time to develop the environment for secondary use by pharmaceutical companies and others.

In this session, the TRIPS waiver, a multilateral treaty agreed at the "12th Ministerial Conference of the World Trade Organization (WTO)" (MC12) on intellectual property concerning the use of technologies such as drugs and vaccines for the treatment of novel coronavirus infection (COVID-19), and concerns about its expansion were discussed. He also introduced the efforts being made in cooperation with IFPMA and other organizations to address concerns about the expansion of the TRIPS waiver. He also introduced EFPIA's efforts, together with its members, to promote humanitarian response, relief measures, donations, etc. to the conflict between Ukraine and Russia, and the prioritization of the pharmaceutical industry at the EU and EU member country levels amid challenges such as supply chains, economic sanctions, and energy price hikes. The last part of the presentation was given by the Pharmaceutical Manufacturers' Association of Japan (PMAJ).

Finally, the Pharmaceutical Manufacturers Association of Japan (PMAJ) gave an overview of the Strategy for Strengthening the Vaccine Development and Production System, which was approved by the Cabinet in June 2021 as a countermeasure against future pandemics in Japan, and various efforts are currently underway.

Concluding Remarks

Mr. Berden of EFPIA expressed his appreciation for the lively and in-depth discussions and the excellent exchange. Mr. Ito, Chairperson of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), echoed Mr. Berden's comments, saying that they had a great discussion on issues shared by Japan and the EU. He also noted that these are unprecedentedly difficult times, not only for the pharmaceutical industry but also for other industries, and that we need to continue to look for solutions to these problems and challenges through collaboration between Europe and Japan.

If you want to go fast, go alone.
If you want to go far, go together.

( Yuji Yahiro, EU Team Leader, Europe Group, Europe and America Division, International Committee)

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