Topics Held regular meeting with the European Federation of Pharmaceutical Industries and Associations (EFPIA).

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The European and American Subcommittees of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) hold regular 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) every year as part of activities to cooperate with European and American governments and pharmaceutical organizations and to resolve international issues. The 2023 meeting with EFPIA was held on November 7 in a hybrid face-to-face and online format, and was a lively exchange of views on current European and Japanese policy issues and the state of industry advocacy.

Ms. Nathalie Moll, Secretary General of EFPIA, opened the meeting by stating that Japan is one of EFPIA's top priority countries and that she considers the opportunity of such an annual meeting very valuable. He expressed his desire to share the challenges that Europe faces, such as access to medicines and information technology, and to discuss best practices and opportunities with each other.

He gave an overview of the proposed amendments to the General Medicines Act published by the European Commission in April 2023 regarding the purpose of the amendments, incentives to promote innovation, improved access to medicines, and stable supply. He also explained EFPIA's views on these contents and its efforts to date.

EFPIA provided an overview of the proposed amendments to the General Medical Products Law and the mechanisms contained in the Compulsory License Bill that threaten the IP system (shortening of data protection periods, expansion of Bolar provisions, etc.), as well as EFPIA's concerns and specific proposals.

During the Q&A session, questions were raised regarding the intent of EFPIA's proposals, and the possibility of joint advocacy on the World Trade Organization (WTO) TRIPS waiver, which is also an issue affecting the IP system, was discussed.

An overview was given on the stable supply of medicines and measures to be taken in the event of shortages.

The EU General Medicines Bill strengthens regulations by requiring the pharmaceutical industry to ensure a stable supply of medicines and by setting a timeframe for advance notification in the event of shortages or stoppages in supply.

EFPIA recommends the establishment of measures to prevent and mitigate shortages, such as the development of a list of critical medicines, and the use of the European Medicines Review System (EMVS), which can predict drug shortages in real time, to ensure a stable supply of medicines and prevent supply shortages and outages. He also recommended the use of the European Medicines Review System (EMVS), which can predict drug shortages in real time.

He introduced the current situation and awareness of issues surrounding the pharmaceutical industry in Japan, the "Kotta Policy 2023" and its impact on the pharmaceutical industry, and the discussion at the Central Social Insurance Medical Council (Chuikyo) regarding the reform of the NHI drug price system in FY2024. During the discussion, questions were asked about the prospects for discussions on cost-effectiveness evaluation and cooperation among industry associations for the reform of the NHI drug price system in FY2024, to which the Pharmaceutical Manufacturers Association of Japan (PMAJ) provided answers.

The Japan Federation of Pharmaceutical Manufacturers' Associations (JFPMA) introduced the current situation and issues related to the stable supply of pharmaceuticals in Japan. He also reported on the measures being taken with each stakeholder, focusing on efforts to overcome the stable supply issue.

During the discussion, EFPIA asked about the impact of the stable supply issue in Japan on drug prices. In Japan, nearly 30% of generic drugs are in the red, and there is a situation where sufficient funds cannot be invested in capital investment to build a system to increase new supply. The Pharmaceutical Manufacturers Association of Japan (PMAJ) responded that Japan is in a situation where it is not possible to invest sufficient funds in facilities to build up the health data.

The Pharmaceutical Manufacturers Association of Japan (PMAJ) shared the background of the establishment of the Headquarters for the Promotion of Digital Transformation (DX) in Healthcare by the government and the status of discussions by the Ministry of Health, Labour and Welfare (MHLW) on the issue of the lack of progress in the secondary use of health data in Japan, and the PMAJ is committed to continue advocacy activities such as requesting the establishment of a national data infrastructure and the development of a legal system to improve efficiency in pharmaceutical research and development. EFPIA also shared the history of the establishment of the MHLW's Headquarters for the Promotion of Information Formation and shared the status of the discussions by the MHLW.

EFPIA also introduced the status of discussions on the European Health Data Space (EHDS), a mechanism for the establishment and utilization of European health data infrastructure, concerns for the pharmaceutical industry, and EFPIA's efforts to establish a better system, following the regular meeting in 2022. The discussion focused on the EHDS.

In the discussion, the Pharmaceutical Manufacturers Association of Japan (PMAJ) asked questions regarding the expectations and concerns of the pharmaceutical industry regarding the EHDS, and EFPIA responded that the biggest concern at present is that data owners do not have the right to refuse access to their data.

Concluding Remarks

Finally, Mr. Nobuo Murakami, Chairperson of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), expressed his appreciation, noting that this was the first face-to-face meeting with EFPIA in four years (since a face-to-face meeting was not possible in 2022 due to problems during transportation). He called for continued discussions on how to strike a balance between creating innovation and ensuring access to medicines, and to seek solutions in cooperation with each other.

( Yuka Hayashizaki, EU Team Leader, Europe Group, Europe and US Subcommittee, International Committee)

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