The "Regular Meeting with the German Association of the Research-based Pharmaceutical Industry (vfa)
The International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), Europe-U.S. Subcommittee holds regular meetings with European pharmaceutical associations every year as part of its activities to cooperate with European and U.S. governments and pharmaceutical associations to resolve international issues. 2025 regular meeting with the German vfa was held on November 7 in a hybrid face-to-face and online format. After the meeting, the participants visited the Embassy of Japan in Germany and met with the secretary of the Embassy. A total of 15 participants from both sides participated in the meeting, including many online participants from the Japan Federation of Pharmaceutical Manufacturers' Associations (JFPMA), and a lively exchange of opinions took place. A summary of the meeting is provided below.
Local venue
Opening Remarks
The meeting started with opening remarks by Mr. Harald Zimmer, Senior Manager of International Affairs at vfa. He commented that this meeting was a testament to the close cooperation and friendship between Germany and Japan, and he looked forward to a fruitful discussion.
Nobuo Murakami, Chairman of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), then expressed his appreciation for the meeting being held in Berlin and emphasized the significance of regular bilateral dialogues. Touching on changes in the environment surrounding the pharmaceutical industry, he shared the sense of crisis regarding the U.S. MFN (Most Favored Nation) policy, geopolitical risks related to trade negotiations, and declining competitiveness, and called for the strengthening of educational activities to emphasize the importance of the pharmaceutical industry to society.
Digital Health
Mr. Dennis Geisthardt
Digitalization in the Health Sector (including AI Applications)
Legislative Discussions for Aligning with the European Health Data Space (EHDS) Regulation
vfa gave an overview of the current status of electronic health records (ePA), which will be mandatory in Germany from October 2025, and the European Health Database (EHDS), which was published in March of this year. During the discussion, a question was asked about the educational activities conducted by the government and pharmaceutical companies to promote the use of ePAs, and whether there were any points that could be used as a reference for the promotion of the Japanese version of EHR. He shared that in Germany, when ePA was first introduced, the participation rate was only about 1% even though they conducted campaigns to communicate the benefits of ePA, but by changing to an opt-out system, the participation rate increased to about 97%.
Miho Funaki, Member, Innovation Promotion Subcommittee, Industrial Policy Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
Promoting the use of medical information databases
Mr. Funaki explained about the revision of laws to promote the use of public databases (DBs), and shared that a bill to allow pseudonymization linkage between the National Database (NDB) and other public DBs will be debated in the Diet in 2025, with the aim of enactment in 2028. He also explained about the enactment of a special law in the medical field under the Personal Information Protection Law, and introduced that the government's study group on the promotion of secondary use of the Japanese version of EHDS will meet from September 2025 to summer 2026, aiming to submit the bill to the ordinary Diet session in 2027. During the discussion, opinions were exchanged on the status of medical data infrastructure development in Japan compared to other Asian countries.
Dr. Nobuhisa Kawahata, Member, Clinical Evaluation Subcommittee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association of Japan (JPMA)
SaMD in Japan
Dr. Kawabata explained the comparison of the approval status and reimbursement system for digital therapy (DTx) between Japan and Germany. During the discussion, the Japanese side asked the German side about the status of DTx diffusion, segmentation with pharmaceutical products, examples of pharmaceutical companies entering the DTx market, and future tightening of the approval system. Two pharmaceutical companies have entered the DTx market, and the fast-track process is working well, although the approval system has become slightly stricter in the past few years.
Drug Pricing & reimbursement Policies
Yoshitaka Kusakai, Chairperson, Industry Promotion Subcommittee, Industrial Policy Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
Pricing System reform
Mr. Kusakai, Chairperson of the Subcommittee, explained the challenges surrounding the Japanese pharmaceutical industry, including the declining predictability of the NHI drug price system, which has reduced the attractiveness of investment. He also stated that although incentives for innovative new drugs and pediatric drugs were introduced in the FY2024 reform of the NHI drug price system, further improvements are needed. He explained that in the discussions for the FY2026 reform, he requested the evaluation of innovation, maintenance of NHI prices for innovative new drugs during the patent term, abolition of market expansion re-calculation, and revision of cost-effectiveness He explained that he has requested a review of the evaluation of innovation, maintenance of drug prices during the patent period of innovative new drugs, abolition of market expansion re-pricing, and cost-effectiveness evaluation. He also mentioned the concern that the U.S. MFN policy exacerbates drug lag and drug loss, and emphasized the importance of institutional reform and market environment improvement to increase the attractiveness of the Japanese market and to attract investment.
Manager Reimbursement Policy, vfa Eike Melchior
Trends Related to Drug Pricing Policies under the New German Government
Current Status and Challenges in Access to Innovative Medicines in Germany
Mr. Eike Melchior shared the German Pharmaceutical Market Restructuring Act (AMNOG), which allows new drugs to enter the market immediately after approval in Europe and insurance coverage. He also mentioned recent developments such as the temporary increase of the manufacturer's discount rate, the introduction of a 20% discount for combination therapies, and the fact that the Health Care Advisory Board (SVR) report has no direct impact on the legislative process. In the questions that followed, vfa responded to mutual interest in the German and Japanese drug pricing systems and the fact that the confidential pricing system is complex and offers little economic benefit, so the impact of the MFN policy will not increase the use of this system.
Discussion
International Policy, vfa Ms. Tanya Herfurth / Ms. Keiko Sato, Director, International Division, Pharmaceutical Association of Japan
Impact of MFN, Trade Policy and Responses
Future Collaboration
Tanya Herfurth shared the impact of the US trade policy and the Presidential Decree on MFN policy on the European pharmaceutical industry. She emphasized the importance of continuous and proactive measures in Germany, which also faces many challenges such as tight insurance finances, aging population, and geopolitical tensions.
General Manager Sato explained the potential impact of the MFN policy on the Japanese market and the response of pharmaceutical associations. It was confirmed that there are common issues and concerns that both Japan and Germany are facing, and it was agreed that both industry associations will continue to work closely together to strengthen their efforts to reach out to stakeholders in each country.
Concluding Remarks
Harald Zimmer of vfa thanked the participants for their active discussions and expressed his hope for further collaboration in the future.
Pharmaceutical Association of Japan Executive Director Sachiko Nakagawa expressed her gratitude for the meaningful exchange of views and opportunities for collaboration, and confirmed the commitment to continued dialogue and joint advocacy in the future, bringing the meeting to a close.
Group photo
(Naoko Iizuka, Team Leader, Germany and France, Europe Group, Europe and North America Subcommittee, International Committee)