Topics The "Regular Meeting with the German Association of the Research-based Pharmaceutical Industry (vfa)

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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 meeting is held every year. The regular meeting with vfa was held on November 8, 2023, in a hybrid face-to-face and online format, with approximately 40 participants from both sides engaged in a lively exchange of views.

Introduction

The meeting started with opening remarks by Mr. Harald Zimmer, Senior Manager of International Affairs at vfa. He expressed his pleasure in hosting the meeting and the importance of exchanging views on issues facing Japan and Germany, as both countries have very similar ways of thinking and values.

In the session that followed, vfa gave an overview of the revision of the EU General Medical Products Law and a presentation on digital health. The Pharmaceutical Manufacturers Association of Japan (PMAJ) introduced their initiatives in Patient Engagement. In addition to the sessions, both vfa and the Pharmaceutical Cooperative Association held Q&A sessions on the topics of Pricing & Reimbursement, Health Technology Assessment (HTA), and Stable Supply, and exchanged opinions on each topic.

An overview was given of the proposed amendments to the EU General Medical Products Act, announced for April 2023, which will reduce bureaucracy and streamline processes, shorten data exclusivity periods, and the German government's position on unmet medical needs.

During the discussion that followed, there were questions about how vfa and EFPIA are working together and what advocacy activities vfa is conducting with German government ministries. vfa indicated that it has organized a working group with EFPIA on the proposed amendments and that they regularly exchange views. The vfa responded that a working group has been organized with EFPIA to regularly exchange views on the proposed amendments, and that close collaboration with stakeholders such as the European Council, the Ministry of the Environment, and the Ministry of the Economy on a daily basis has enabled constructive discussions.

He explained the impact analysis and evaluation of the German law enacted in November 2022, the Act on Financial Stability of the Central Union of Public Health Insurance (GKV-FinStG), the direction of the necessary future institutional review, and vfa's actions. Concerns were shared about possible negative effects, such as possible obstacles to patients' access to medicines and a decrease in Germany's attractiveness as a pharmaceutical industry center. Since the effects of this law will be felt over the medium to long term, it is necessary to continue the analysis and discussion.

He gave an overview of the Act to Prevent Shortages and Improve the Supply of Generic Medicines (ALBVVG). vfa is introducing an early warning system as part of its efforts to diversify its supply chain in order to improve the supply of medicines.

The early warning system is intended to detect shortages of medicines at an early stage and respond to them efficiently. This minimizes the impact on patients. He also mentioned the need to consider the issue of generic drugs and patented drugs from the perspective of the pharmaceutical industry as a whole, rather than in isolation.

He explained the background and overview of the enactment of Japan's Economic Security Promotion Act. He mentioned that antimicrobials were designated as Specified Critical Goods and that we must join forces with important partners such as the EU and the US in order to strengthen the supply chain.

During the discussion, he was asked about the industry's involvement in the bill and whether or not an impact assessment has been conducted. He responded that the Pharmaceutical Manufacturers Association of Japan (PMAJ) has issued public comments and is conducting an assessment of the impact of the bill on the industry.

The main focus of the presentation was on the causes and current status of the short supply of generic drugs in Japan. The scandals of generic drug companies that triggered the supply problem and the structural issues faced by the generic industry were introduced.

During the discussion, questions were asked about the causes of the concentration of production in a few companies, the degree of dependence of APIs on foreign countries, and the relationship between the promotion of generic use and supply problems, to which the Japan Federation of Pharmaceutical Manufacturers' Associations (JFPMA) provided answers.

The Pharmaceutical Manufacturers Association of Japan (PMAJ) made a presentation and held a discussion on its activities related to collaboration with patient groups. The Pharmaceutical Manufacturers Association of Japan (PMAJ) introduced the objectives and specific activities of the Committee for Promotion of Collaboration with Patient Groups, and the vfa asked questions about the relationship with patient groups and the historical background, to which the PMAJ responded.

The current status of digitization of healthcare in Germany and an overview of the Act on Acceleration of Digitization of Healthcare (DigiG) and the Act on the Utilization of Health Data (GDNG), among others, were explained.

During the discussion, the participants were asked about the reasons for the lack of digitization of healthcare in Germany and the level of acceptance of DiGA (digital health apps) by healthcare professionals, and they answered that the users of DiGA are hesitant to use it and that healthcare in general tends to be reluctant to take on new initiatives. vfa asked about the digital health-related system in Japan, to which the two-step approval system based on the German model is being considered.

Concluding Remarks

Mr. Zimmer of vfa commented that the session was as interesting and informative as the previous one, and expressed his gratitude to those involved in organizing the meeting.

Mr. Hisashi Nakagaki, Vice-Chairman of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), stated that it is important to continue cooperation and information exchange between the two organizations, as they share the common goal of improving patient access to sustainable healthcare systems.

( Masato Nagai, Team Leader, Germany Team, Europe Group, Europe and North America Subcommittee, International Committee)

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