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 cooperate with European and American governments and pharmaceutical organizations and to resolve international issues. The company has been holding regular meetings with EFPIA every year. The regular meeting with EFPIA was recently held on December 2, 2021, in an online format; we hold regular meetings with EFPIA twice a year, and this was the second meeting in FY2021. Approximately 25 people from both sides participated in the meeting, and a lively exchange of opinions took place. The following is a summary of the meeting.
Scene of the online meeting
Introduction
At the beginning of the meeting, Mr. Koen Berden, EFPIA Executive Director, gave an opening address, followed by a report on the current status of novel coronavirus infection (COVID-19) from both EFPIA and the Pharmaceutical Association of Japan (PSA).
In the session that followed, EFPIA reported on the status of its response to the TRIPS Waiver (waiver of intellectual property related to COVID-19), an overview of the EU HTA Regulation and EFPIA's engagement strategy in response to it, the current status of the EU Pharmaceutical Strategy and EFPIA's strategy for the EU Pharmaceutical Strategy, and the current status of the EU Pharmaceutical Strategy and EFPIA's strategy for the EU Pharmaceutical Strategy were explained, and a discussion was held.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) introduced the "PMAJ Policy Proposal 2021," a summary of the "Pharmaceutical Industry Vision 2021" recently released by the Ministry of Health, Labour and Welfare (MHLW), and a statement from the PMAJ, followed by an exchange of opinions in response to questions from EFPIA.
COVID-19 TRIPS Waiver
Shinichi Miura, Chairman, International Affairs Committee, EFPIA
Mr. Koen Berden, Executive Director, International Affairs, EFPIA
The session began with a sharing of information on the status of novel coronavirus infection in both countries. The Pharmaceutical Manufacturers Association of Japan (PMAJ) reported on the number of patients and vaccination coverage in Japan, as well as Japan's waterfront measures against the Omicron mutant strain, which has recently become a problem in Japan. EFPIA similarly shared information on the rapid spread of the Omicron mutant strain and the different national responses in EU member countries.
Next, the TRIPS Waiver, which has been under discussion at the World Trade Organization (WTO) since October 2020, was discussed, with the current positions of both the Japanese and EU governments, as well as those of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and EFPIA shared.
Environment Changes in Japan: New government, Recognition of the innovative pharmaceutical industry as contributor to growth and innovation
International Committee of the Pharmaceutical Consortium of Japan (PPCJ), Europe/US Subcommittee Chairman: Shinichi Miura
The session began with an introduction of the background of the "Pharmaceutical Manufacturers Association of Japan (PMAJ) Policy Proposal 2021" and the "Pharmaceutical Industry Vision 2021" of the Ministry of Health, Labour and Welfare (MHLW). Then, a summary of the "Pharmaceutical Manufacturers Association of Japan Policy Proposal 2021" and the joint press conference with PhRMA Japan and EFPIA Japan on May 17, 2021 were mentioned, followed by a summary of the "Pharmaceutical Industry Vision 2021" and the Pharmaceutical Manufacturers Association of Japan's statement on it. Finally, the newly formed Fumio Kishida Cabinet and its policies were introduced.
During the discussion, EFPIA asked about the Japanese government's approach to economic security, the approach of Japanese domestic companies, and the Key Performance Indicators (KPI) in the public-private dialogue working group for the "Pharmaceutical Industry Vision 2021. Questions were asked, and opinions were exchanged on the ideas of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and other issues.
EU HTA Regulation: EFPIA Engagement Strategy 1.
Senior Manager, Market Access, EFPIA Mr. Mihai Rotaru
In this session, an overview of the forthcoming EU HTA Regulation and EFPIA's engagement strategy for the Regulation were presented. The EU HTA Regulation consists of four areas: Joint Clinical Assessment, Joint Scientific Consultation, Horizon Scanning, and Voluntary Cooperation in other areas, and is expected to be phased in from January 2025 after the details are finalized over the next three years. In preparation for this, EFPIA's engagement and advocacy at both EU and Member State levels, including the HTA Working Group workstreams, were introduced to ensure that the EU HTA Regulation provides timely and high quality assessments and is a driving force for improving patient access. An introduction was given.
EU Pharmaceutical Strategy
Revision Orphan and Pediatric Medicines Regulation
Director, Market Access & OMP Policy Lead, EFPIA Ms. Tina Taube
The session covered the current status of the Pharmaceutical strategy proposed by the European Commission (a review of over 50 different regulations) and EFPIA's strategy to address it, The key points are to form a regulatory framework that drives global innovation, to ensure IP incentives including orphan drugs and children, to shape the debate on requirements for access and R&D cost transparency, and to avoid falling prey to strict supply obligations and withdrawal rules. and the risks faced in achieving these goals. He also introduced EFPIA's strategy, which is divided into three categories: regulatory, incentive, and access, and further organized into offensive (topics that can be proactively proposed and realized) and defensive (topics that cannot be proactively addressed).
During the discussion, the Pharmaceutical Manufacturers Association of Japan (PMAJ) asked questions regarding EFPIA's definition of unmet medical needs and the impact of European regulatory reform on foreign companies, including Japanese companies (matters that are difficult to deal with or may become barriers to entry), which were answered in detail by EFPIA.
Structured Dialogue, Supply Chain Security
Director, International Affairs, EFPIA Ms. Jana Nackberg
In this session, the Structured Dialogue was introduced, and EFPIA explained that while there are some positive aspects to this strategy, there are also items of concern to European pharmaceutical companies, such as mandatory supply and transparency of supply prices, which will need to be closely monitored. The discussion was led by the Pharmaceutical Manufacturers' Association of Japan (PMAJ).
During the discussion, the Pharmaceutical Association asked about the relationship with HERA (European Health Emergency Preparedness and Response Agency), which was established in September 2021, and EFPIA provided a detailed response.
Concluding Remarks
In other discussions, the participants followed up on lobbying activities to the relevant authorities related to Brexit, which were handled by EFPIA and the Pharmaceutical Cooperative International Committee in cooperation in FY2021, and also confirmed future collaboration.
The three-hour meeting was concluded by Mr. Tatsuya Ito, Chairperson of the International Committee of the Pharmaceutical Manufacturers' Association of Japan (PMAJ), who thanked EFPIA for the interesting presentation and expressed his desire to continue cooperation toward achieving the common goal of fair and appropriate evaluation of innovation.
Although the meeting was again held online, the active exchange of ideas and opinions during each session was very fruitful in deepening mutual understanding. The next meeting will be held in the spring of 2022.
(International Committee, Europe and America Subcommittee, Europe Group)