Topics Regular meeting with the German Association of the Research-based Pharmaceutical Industry (vfa)" was held

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The JPMA International Affairs Committee's European & American Subcommittee holds annual meetings with the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Association of the British Pharmaceutical Industry (ABPI), the French Association of the Pharmaceutical Industry (Leem), and the German R&D-based Pharmaceutical Industry Association (vfa) as part of its activities to resolve international issues in cooperation with European and American governments and pharmaceutical organizations. 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, since the two 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. JPMA introduced its initiatives in Patient Engagement. In addition to the sessions, both vfa and JPMA 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.

In 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 talked about the need to consider the issue of generic 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 JPMA has issued public comments and is conducting an assessment of the impact 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 JPMA made a presentation and held a discussion on its activities related to collaboration with patient groups. JPMA introduced the objectives and specific activities of the Patient Cooperation Committee, and vfa asked questions regarding the nature of the relationship with patient groups and historical background, to which JPMA 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 Chairperson of the JPMA International Affairs Committee, stated that it is important to continue to work together and exchange information, as both organizations have the common goal of improving patient access to sustainable healthcare systems.

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

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