Topics Held regular meeting with the European Federation of Pharmaceutical Industries and Associations (EFPIA).
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 resolve international issues in cooperation with governments and pharmaceutical organizations in Europe and North America. The company has been holding regular meetings with EFPIA every year. The regular meeting with EFPIA was held on May 31, 2022 in online format. The meeting was attended by nearly 30 participants from both sides, and a lively exchange of opinions took place. A summary of the meeting is provided below.
The venue
Opening Remarks
Chairman, International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Mr. Koen Berden, Executive Director, International Affairs, EFPIA
Opening remarks were made by Mr. Tatsuya Ito, Chairperson of the International Committee of the Pharmaceutical Association of Japan (PAK), and Mr. Koen Berden, Executive Director, International Affairs, EFPIA. While expressing concern over Russia's invasion of Ukraine, Mr. Ito mentioned that life in many countries is returning to normal after the "war against the new coronavirus," and quoted John Adams, the second president of the United States, who said, "The crisis is actually an opportunity. He also called for further cooperation between EFPIA and the Pharmaceutical Manufacturers Association of Japan (PMAJ), saying that the challenges facing the pharmaceutical industry can be turned into opportunities.
Mr. Berden then touched on the impact of the invasion of Ukraine, and expressed his appreciation for the ongoing dialogue and cooperation between EFPIA and the Pharmaceutical Cooperative Association (PPCA) amidst the many other challenges facing the industry. He also noted that the discussion was very timely as the EU Pharmaceutical Strategy is being revised, and expressed his hope to hold the next meeting face-to-face.
EU Pharmaceutical Strategy
Ms. Alexandra Tamas, EFPIA
The session focused on two initiatives that are expected to have a significant impact on the pharmaceutical industry with regard to the EU Pharmaceutical Strategy: the revision of the General Pharmaceutical Law and the revision of the orphan and pediatric drug regulations, and explained their main contents. Both of these are scheduled for adoption by the end of 2022.
EFPIA also shared its proposals on these legislative amendments and on improving access to medicines in the EU, which is one of the objectives of the Pharmaceutical Strategy as a whole.
WTO TRIPS waiver
Mr. Mitsuo Fujii, Director of Intellectual Property, Pharmaceutical Association of Japan
Mr. Koen Berden, EFPIA
This regular meeting was held just before the 12th Ministerial Conference of the World Trade Organization (WTO). In this session, we shared how the Pharmaceutical Association and EFPIA have been interacting with stakeholders on the WTO TRIPS Waiver as a key issue for both parties, and recognized the importance of focusing on the truly critical issues for equitable access to vaccines and therapeutics. We shared our recognition of the importance of focusing on the truly critical issues for equitable access to vaccines and therapeutics.
Subsequently, at the WTO Ministerial Meeting, a TRIPS Waiver was agreed upon regarding vaccines for novel coronavirus infection (COVID-19), and both the Pharmaceutical Manufacturers Association of Japan and EFPIA issued a statement*1.
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1Pharmaceutical Association Statement on the TRIPS Weber Agreement at the 12th WTO Ministerial
https://www.jpma.or.jp/news_room/release/news2022/220620.html
EFPIA Statement on the TRIPS Weber Agreement: EFPIA and Vaccines Europe are deeply disappointed about the decision taken by the World Trade Organization (WTO) at the Ministerial Conference (MC12) to endorse a TRIPS waiver for COVID-19 vaccines
https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/efpia-is-deeply- disappointed-about-the-decision-taken-by-world-trade-organization-wto-at-the-ministerial-conference-mc12-to-endorse-a-trips-waiver -for-covid-19-vaccines/
Activities for Honebuto and Pricing Issues in the Japanese Market
Kuniaki Takatsuki, Leader, Advocacy Group, Industry Policy Committee, Pharmaceutical Manufacturers Association of Japan (PAPJ)
Yoshitaka Kusakai, Chairman, Industry Promotion Subcommittee, Industrial Policy Committee, Pharmaceutical Manufacturers Association of Japan (PAL)
Mr. Leon Ochiai, EFPIA Japan
In this session, the Pharmaceutical Manufacturers Association of Japan (PMAJ) introduced the activities and roles of the Advocacy Group, the activities related to the "Kottai-no-Soshi" policy, and an overview of the NHI price reform in FY2022. EFPIA Japan introduced the areas of activities of EFPIA Japan and the joint proposal of the three pharmaceutical organizations (EFPIA Japan, the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Pharmaceutical Manufacturers Association of Japan (PMAJ)) to the "Framework Policy" and Growth Strategy.
During the discussion, participants exchanged opinions on the Japanese government's approach to drug discovery innovation, elements necessary to realize innovation, handling of medical data, creation of a drug discovery ecosystem and fostering bio-ventures, and confirmed the sharing of issues and future collaboration within the pharmaceutical industry.
Discussion
Yuji Yahiro, Leader, Europe Group, Europe and America Subcommittee, International Committee, Pharmaceutical Manufacturers Association of Japan
Fumiko Kiyonaga, Leader
In this session, EFPIA and the Pharmaceutical Association of Japan (PAK) exchanged views on cooperation in advocacy activities based on the discussions at the 2021 meeting.
EFPIA shared ideas to start discussions on the possible contribution of the pharmaceutical industry in relation to the "EU-Japan Digital Partnership" announced at the Japan-EU Summit in May 2022, as well as on strengthening the supply chain in light of COVID-19 and the situation in Ukraine. Ideas to initiate discussions, etc. were shared.。 The Pharmaceutical Association of Japan (PTAJ) and EFPIA agreed to discuss priorities and concrete steps to be taken in response to EFPIA's proposals in preparation for the next meeting in the fall, and both parties agreed to continue their efforts in this regard.
Concluding Remarks
Mr. Nobuo Murakami, Vice-Chairman of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), spoke about the EU Pharmaceutical Strategy, the TRIPS Waiver, and Japan's Framework Policy, all of which were the topics of the day's discussion, and stressed that they are all important issues that we must address in order to build a better world and continue to provide innovation to patients. He stressed that we need to cooperate with each other more in order to build a better world and to continue to provide innovation to patients. He also stated that he believes that the collaboration between the Pharmaceutical Consortium and EFPIA will become more important, more constructive, and more fruitful in the future, and that he is looking forward to the opportunity to discuss this face-to-face in Brussels this fall.
EFPIA's Koen Berden added that we are living in difficult times, and that never before have the issues been so large or so numerous at the same time. He concluded by saying that he was very grateful for the timely discussion of these issues and hoped that the excellent collaboration between EFPIA and the Pharmaceutical Cooperative Association would continue in the future.
Scene of the online meeting
( Yuji Yahiro and Fumiko Kiyonaga are leaders of the Europe Group of the Europe and America Subcommittee of the International Committee)