Topics Held "Regular Meeting with the European Federation of Pharmaceutical Industries and Associations (EFPIA)
The JPMA International Affairs Committee's European & American Subcommittee holds regular 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) every year as part of its activities to resolve international issues in cooperation with governments and pharmaceutical organizations in Europe and the United States. 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.
The venue
Opening Remarks
Director General, EFPIA Ms. Nathalie Moll
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.
EU Legislation and Policies
General Pharmaceutical Legislation
Director, Market Access & Orphan Drug Policy Lead, EFPIA Ms. Tina Taube
Explanation of the proposed amendments to the General Medicines Act published by the European Commission in April 2023 was given, including the purpose of the amendments, incentives to promote innovation, and an overview of the proposed amendments regarding improved access to and stable supply of medicines. He also explained EFPIA's views on these contents and its efforts to date.
Compulsory Licensing
Director, Intellectual Property Policy, Mr. Michael Swita, EFPIA
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.
Supply chain and open strategic autonomy
Executive Director, Economic and Social Affairs, Mr. Francois Bouvy, EFPIA
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.
Japan Legislation and Policies
Basic Policy on Economic and Fiscal Management and Reform (phonebuto) in 2023 and
Pricing reform debate
Mr. Hiroki Iida, Member, JPMA Industrial Policy Committee, Industrial Promotion Subcommittee
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, the JPMA responded to questions regarding the prospects for discussions on cost-effectiveness evaluation and cooperation among industry associations for the reform of the NHI drug price system in FY2024.
Drug shortages in Japan
Mr. Kenichi Kajiyama, Chairperson, Stability Assurance Committee, Japan Federation of Pharmaceutical Manufacturers' Associations
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.
Digitization in Health
Shohei Shirakami, Vice Chairperson, Innovation Promotion Subcommittee, JPMA Industrial Policy Committee
Ms. Aneta Tyszkiewicz, Senior Manager Digital and Data, EFPIA
The JPMA 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 regarding the issue of the lack of progress in the secondary use of health data in Japan, and requested the establishment of a national data infrastructure and the establishment of a legal system to improve the efficiency of pharmaceutical R&D. The JPMA will continue to advocate for the establishment of a national data infrastructure and the establishment of a legal system. 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.
During the discussion, JPMA 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 holders have no right to refuse access to their data.
Concluding Remarks
Finally, Mr. Nobuo Murakami, Chairperson of the JPMA International Affairs Committee, expressed his gratitude, noting that this was the first face-to-face meeting with EFPIA in four years (since the face-to-face meeting in 2022 was not possible 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.
Group photo
( Yuka Hayashizaki, EU Team Leader, Europe Group, Europe and America Subcommittee, International Affairs Committee)