The "Regular Meeting with the German Association of the Research-based Pharmaceutical Industry (vfa)
Jan 10, 2025
The European and American Subcommittees of the International Committee of the Pharmaceutical Association of Japan (IACJ) hold regular meetings with European pharmaceutical associations every year as part of their activities to cooperate with European and American governments and pharmaceutical associations and to resolve international issues. In the second half of the meeting, for the first time at a regular meeting, a free discussion was held with the vfa, followed by a visit to the Japanese Embassy in Germany to meet with the secretary.
Photo: Local venue
This year's meeting was attended by 17 local participants from both sides and many online participants, including the Japan Federation of Pharmaceutical Manufacturers' Associations (JFPMA), and a lively exchange of views took place.
A summary of the meeting is as follows
Introduction
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.
Pricing & Reimbursement, HTA: GKV-FinStG updates, impact on EU-HTA and Medical Research Act (MFG)
Mr. Eike Melchior, Manager Reimbursement Policy, vfa
Mr. Harald Zimmer shared the results of a vfa study on the impact of the GKV-FinStG (Central Federation of Public Health Insurance Financial Stabilization Act) enacted in November 2022 on the supply of innovative medicines and the production base, and reported that there are signs of negative impact on innovation and the German business environment. The report showed that there are signs of a negative impact on innovation and the German business environment. On the other hand, a study by the German Ministry of Health reported that it is too early to assess the impact and that ongoing assessments will be conducted. He also outlined the amendments to the Medizinforschungsgesetz, MFG (Medical Research Act), passed in July 2024, which were reportedly intended to re-enhance Germany's attractiveness as a research and production center for the pharmaceutical industry, but which have been positive for the industry. He mentioned the need for continuous discussion for concrete implementation of the amendment as it is not only a positive amendment.
Updates on expensive drugs and drug pricing system reform in Japan
Mr. Yoshitaka Kusakai, Insurance Drug Pricing Research Committee, Japan Federation of Pharmaceutical Manufacturers' Associations
Mr. Kusakai explained about the NHI reform in Japan for FY2024, the government's efforts to strengthen drug discovery capabilities, and the handling of high-cost drugs. In April 2024, the Pharmaceutical Manufacturers Association of Japan (PMAJ), together with the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), released a joint statement on drug price reform for FY2024. During the discussion, German and Japanese participants exchanged their views on cost-based and value-based drug pricing, and discussed the possibility that rules regarding the handling of high-cost drugs could lead to drug loss and drug lag problems.
Digital Health: DigiG/GDNG updates, actual usage of DiGA, industrial interest on the development of DiGA
vfa
vfa gave a brief overview of the law on the acceleration of digitization of healthcare (DigiG) and the law on the utilization of health data (GDNG), both of which were passed by the German parliament in 2023. Recent developments in the digital health apps (DiGA) market were also presented. During the discussion, a question was asked about the background of skepticism about the usefulness of DiGAs despite the increasing number of approvals. It was shared that relatively young doctors tend to prescribe DiGAs in the medical field, and that the government is concerned about short-term costs incurred by the disease safeguards and has questions from a long-term perspective.
AMR countermeasures
Mr. Yusuke Ariyoshi, Member, Global Health Subcommittee, International Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
Senior Manager International Affairs, vfaMr. Harald Zimmer
Presentations were made by Dr. Ariyoshi and Dr. Harald Zimmer on the antimicrobial incentive systems in Japan and Germany, respectively. Dr. Ariyoshi introduced the Japanese Antimicrobial Securement Support Program (Antimicrobial Securement Support Program), including how antimicrobial agents are selected, how the subsidy is calculated, and how the selected companies respond. Dr. Harald Zimmer presented hospital reimbursement for reserve antibiotics, TEEs, Advocacy, and the organizations that are active in the program. In the Q&A session, he shared information about the BEAM Alliance, DNAMR, AMR R&D Hub, and other organizations that are active in this area.
Stable Supply: ALBVVG updates
Mr. Eike Melchior, Manager Reimbursement Policy, vfa
Eike Melchior gave an overview of the Act to Prevent Shortages and Improve the Supply of Generic Products (ALBVVG). The law aims to strengthen the supply of essential medicines for pediatric use, antibiotics, and generics. He introduced, for example, the relaxed pricing for pediatric use and essential medicines, and the obligation to stock generics.
Stable Supply: Japan status updates
Mr. Naohiro Watanabe, Insurance Drug Pricing Research Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
The current situation and causes of insecurity of supply of medicines in Japan, efforts for stable supply, related NHI price rules, and market withdrawal were explained. The discussion also covered issues related to market withdrawal.
During the discussion, questions were asked about challenges in market withdrawal and measures to be taken in the case of unprofitable products. After introducing the system of re-calculation of unprofitable products, the participants responded that the industry is working to relax the withdrawal criteria and the conditions for application of re-calculation of unprofitable products.
Discussion: Future collaboration between vfa and JPMA
For the first time as a regular meeting, time was set aside for discussion, providing an opportunity for both organizations to consider how best to work together in the future. The participants agreed to continue to work closely with each other.
Concluding Remarks
Harald Zimmer of vfa commented on the interesting and informative discussion and thanked everyone involved in organizing the meeting.
Mr. Hisashi Nakagaki, Vice Chairperson of the International Committee of the Pharmaceutical Association of Japan (PAK), stated that as many countries are trying to meet healthcare costs and promote innovation with limited budgets, it is important for both organizations to have common objectives and continue to collaborate with each other while closely monitoring their development.
Group photo
(International Committee, Europe and America Section, Europe Group, Germany-France Team)