Held regular meeting with the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Mar 07, 2025
The European and American Subcommittees of the International Committee of the Pharmaceutical Association of Japan (IPAJ) hold regular meetings with European pharmaceutical organizations every year as part of their activities to cooperate with European and American governments and pharmaceutical organizations and to resolve international issues. The meeting was attended by about 30 participants from both sides, and a lively exchange of views took place. The following is a summary of the meeting.
Scene of the online meeting
Introduction
The meeting started with opening remarks by Mr. Thomas Gelin, Executive Director of EFPIA. He commented that this meeting was an indication of the importance of cooperation between Europe and Japan, and that he hoped to explore ways to strengthen collaboration toward 2025 through information exchange. Ms. Sachiko Nakagawa, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), also commented that EFPIA and PMAJ have been cooperating with each other for many years and that she looked forward to a frank exchange of views at this meeting.
Policy landscape after EU election - impact on the healthcare industry and EFPIA's advocacy strategy & Update on the revision of the EU pharmaceutical legislation (RDP and access) and EFPIA 2025 advocacy strategy
Ms. Martina D'Amore, Public Affairs, EFPIA
Ms. Martina D'Amore introduced the current political situation in the EU in 2024 and the current status of the revision of the European OTC drug regulation.
During the Q&A session, the participants discussed EFPIA's advocacy activities, including its collaboration with EU member states and non-EU countries such as the UK and the US, and its activities based on data collection and analysis in order to understand the disparities in access to healthcare between Western and Eastern Europe.
Urban Wastewater Treatment Directive (UWWTD)
Ms. Athina Giannoutsou, Public Affairs, EFPIA
Athina Giannoutsou gave a presentation on the EU's Urban Wastewater Treatment Directive. The Directive aims to protect the environment and improve the health of citizens, and mandates higher levels of wastewater treatment throughout the EU.
During the question-and-answer session, there were questions about how the law will be reflected in the national laws of each EU member state and the financial burden to be borne only by the pharmaceutical and cosmetics industries, etc. Although there is some flexibility among EU member states, the basic content is expected to be unified. The concerns about the impact on the pharmaceutical industry, such as the loss of competitiveness of companies, etc., were also mentioned.
Update on Japan pricing and reimbursement environment
Mr. Yoshitaka Kusakai, Chairman, Industry Promotion Subcommittee, Industrial Policy Committee, JPMA
Mr. Yoshitaka Kusakai, Chairperson of the Sub-Committee, gave an overview of the reform of the NHI drug price system in FY2024, and explained that the policy has shifted in the direction of evaluating innovative drugs and promoting innovation. He also shared that these reforms are the result of industry activities achieved through active lobbying in cooperation with EFPIA and PhRMA (U.S. Research Pharmaceutical Manufacturers Association).
Industry proposals for the 2025 mid-year revision and the government's revision policy were also outlined. During the discussion, the participants exchanged views on advocacy and other issues related to future NHI reform.
Safety of supply: Progress of Critical Medicine Alliance/Act
Mr. Pablo Tovar, Economic and Social Affairs, EFPIA
Pablo Tover introduced EFPIA's activities through the European Critical Medicines Act and the Critical Medicines Alliance (the "Alliance") on the topic of stable supply.
In Europe, following the pandemic, the insecurity of pharmaceutical supply has become an important health policy issue at the EU and national level, and a Critical Medicines Act is expected to be enacted to ensure the stable supply of critical medicines and to address supply chain vulnerabilities. The Alliance has been established as a forum for comprehensive discussion of the legislation, and discussions are underway, including with EFPIA. During the Q&A session, questions and opinions were exchanged on the impact on Europe in light of the political developments in the U.S. and the future prospects.
European Collaboration on Health Technology Assessment
Mr. Mihai Rotaru, Market Access, EFPIA
Dr. Mihai Rotaru gave an overview of the EU Joint Health Technology Assessment (HTA), which will be operational from 2025. He explained that there has been no common framework for HTA in Europe, but with the introduction of the EU Joint HTA, a Joint Clinical Assessment (JCA) will be implemented, which will streamline the clinical assessment of HTA in EU countries. He also mentioned that, since HTAs will be given the opportunity to seek scientific advice from not only the European Medicines Agency (EMA) but also from HTA organizations at the planning stage of clinical trials, it is expected that clinical development plans will be designed more appropriately, while it has not yet been decided how to utilize the Joint Clinical Assessment reports in each country. On the other hand, he mentioned that each country has not yet decided how to utilize the Joint Clinical Assessment Report.
Discussions on the collaboration between EFPIA and JPMA
The results of past activities in both Japan and Europe were shared, and there was a discussion on how the two organizations can work together in the future. As an example of collaboration, the possibility of submitting a statement or letter to the European government jointly by the three organizations was mentioned, in response to the joint statement issued by EFPIA, PhRMA, and the Pharmaceutical Manufacturers Association in Japan.
Concluding Remarks
Mr. Thomas Gelin, Executive Director of EFPIA, expressed his gratitude for the fruitful exchange of views and his hope that the two organizations will continue to strengthen their collaboration and actually work together.
Mr. Nobuo Murakami, Chairman of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), commented that he would like to strengthen cooperation between EFPIA and PMAJ for the future development of the industry as a whole and to build a better future.
(Mr. Shun Inoue, EU Team Leader, Europe Group, Europe and America Division, International Committee of the Pharmaceutical Association of Japan)