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 their 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 24, 2022, in a hybrid face-to-face and online format, with approximately 30 participants from both sides engaged in a lively exchange of ideas. A summary of the meeting is provided below.

Introduction

The meeting started with opening remarks by Mr. Harald Zimmer, Senior Manager of International Affairs at vfa. He expressed his pleasure at the fact that the meeting was the first face-to-face meeting in three years, and his hope that the discussion would deepen the knowledge of the participants.

In the session that followed, vfa gave a presentation on the General situation of the Central Federation of Public Health Insurance's Financial Stability Law (GKV-FinStG) and on the Health Technology Assessment (HTA).

The Pharmaceutical Manufacturers Association of Japan (PMAJ) presented an overview of the Framework Policy announced in 2022 and its impact on the industry, as well as the PMAJ's efforts toward the G7 Hiroshima Summit 2023.

In addition to each session, a Q&A session was held under the theme of Pricing & Reimbursement, where both vfa and the Pharmaceutical Manufacturers Association of Japan (PMAJ) exchanged opinions on the respective topics.

In this session, vfa introduced the details of the GKV-FinStG, which was approved in November 2022, and expressed strong concerns about the regression of the access environment to medicines in Germany, including the shortening of the free pricing period for new drugs and the reduction of prices for drugs used in combination therapy.

During the Q&A session, he mentioned the difficulties in the future outlook for discount rates, etc. as stipulated in the GKV-FinStG, and the fact that Germany, like Japan, has an aging population, and that the growing GKV*1 deficit has affected the enactment of the GKV-FinStG. He also explained the contradictory situation in the European Union (EU), where high drug prices have become a problem from a financial point of view, in relation to regulations that conflict with the policy of improving access to rare disease medicines. He also recognized that the country is now facing a variety of challenges accumulated since the previous administration.

Pricing & Reimbursement

This session was followed by a discussion on the German drug pricing and reimbursement system. The Pharmaceutical Association of Japan asked questions about the current status of drug transactions at pharmacies and wholesalers, and the impact of global inflation and energy price hikes on the stable supply of medicines, which were answered by the vfa. The vfa also recognized the need to closely monitor how the tightening of regulations on drug prices and insurance reimbursement in Germany would affect access to medicines.

This session included an introduction to the current situation regarding the NHI drug pricing system in Japan, where NHI prices have been reduced for five consecutive years since 2018, indicating a continuing drug lag or drug loss for new drugs and a declining competitiveness of the Japanese market. Countermeasures to address these issues included a review of the NHI drug price system, drug regulations, and solutions related to the clinical research environment. He also introduced the pharmaceutical industry's expectations for the Ministry of Health, Labour and Welfare's newly established expert panel as an opportunity to discuss these issues in a comprehensive manner.

During the Q&A session, vfa asked questions about the Japanese government's support measures for pharmaceutical supply issues and where the responsibility for stable supply lies, which were answered by the Pharmaceutical Manufacturers Association of Japan (PMAJ).

During this session, the Health Agenda for the G7 Hiroshima Summit 2023, to be held in May 2023, was introduced. The proposal was prepared in the form of a joint proposal by the Pharmaceutical Manufacturers Association of Japan (PMAJ) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), and stated the need for sustainable investment in innovation to create a more equitable and sustainable health system and the infrastructure to support it in the midst of a global pandemic.

Germany was the previous host country of the G7, and the Pharmaceutical Association of Japan (PAK) expressed its deep appreciation for vfa's support to date for hosting the meeting in Japan, and reaffirmed its commitment to continue to work closely together.

In this session, the background of the legislation, basic information, and the German position on the European HTA, which will start to apply to some medicines in 2025, were explained from the perspective of a practitioner who was actually involved in the HTA at the German Institute for Quality and Efficiency in Medicine (IQWiG).

The regulation has three major goals: (1) to improve the availability of innovative medical technologies to European patients, (2) to ensure efficient use of resources and enhance the quality of HTA across Europe, and (3) to improve business predictability. However, concerns were expressed that the published guidance for the European Network for Health Technology Assessment (EUnetHTA) 21 is far from its original purpose, creating an unprecedented duplication of effort, and that the voices of industry continue to be ignored in the guidance. In particular, access to the Joint Scientific Consultations (JSC) is restricted and potentially denied, which was described as a fatal error.

Concluding Remarks

Mr. Zimmer of vfa thanked the JSC for hosting this meeting, which resulted in useful discussions, and noted that he was impressed by the JSC's efforts to address issues related to Japan's Framework Policy and the pharmaceutical market, and that intensive follow-up is needed in the future. Nobuo Murakami, Vice Chair of the Pharmaceutical Association of Japan (PAK) International Committee, stated that while Japan and Germany are facing difficult situations with each other, they would like to make a balanced proposal in order to maintain a sustainable healthcare system, industry growth, and patient access to medicines. He also mentioned the usefulness and importance of face-to-face discussions and stressed that he would like to maintain the relationship and continue discussions with both vfa and the Pharmaceutical Association.

( Takashi Hisamura, Team Leader, Germany Team, Europe Group, Europe and America Subcommittee, International Committee)

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