Topics Held a regular meeting with the French Association of the Pharmaceutical Industry (Leem).

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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. On November 9, 2023, the regular meeting with Leem was held in a hybrid face-to-face and online format, and a lively exchange of views took place.

At the beginning of the meeting, Mr. Philippe Lamoureux, Chairman of Leem, expressed his gratitude for the past activities with the Japan Pharmaceutical Manufacturers Association (JPMA) and the importance of maintaining and expanding exchanges between Japan and France, as he will retire as Chairman of Leem at the end of 2023. Ms. Sachiko Nakagawa, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), expressed her gratitude to Mr. Lamoureux for strengthening the ties between Leem and the PMAJ, looking back on her memories of him.

He reviewed the current situation caused by the long-standing policy of drug price suppression in France, and introduced the social security financing bill for 2024. As a result of the negotiations, both price reductions and reimbursements were spared in 2024, but only one-third of the drugs approved in the EU are reimbursed in France within three years, a situation similar to Japan in that the drug lag/loss is becoming more serious. Leem is proposing a system to optimize the excessive prescribing of pharmaceuticals as part of measures to curb medical costs.

The main focus was on the Early Access system introduced in France in FY2021, with an explanation of the details of the system, its operational status, and issues. In the discussion, opinions were exchanged on the overall access to medicines in Japan and France, and Mr. Leem responded to the operation status of the system and issues for venture companies in France.

The current situation and recognition of issues surrounding the pharmaceutical industry in Japan, the "Kotta Policy 2023" and its impact on the pharmaceutical industry, and discussions at the Central Social Insurance Medical Council (Chuikyo) regarding reform of the NHI drug price system in FY2024 were introduced. During the discussion, a lively Q&A session focused on topics common to both countries, such as the aging of the population and social security costs, and challenges in procuring APIs.

The current situation and background of the drug supply shortage in France and the outline of the roadmap for stable supply from 2023 to 2025 were introduced. The main points of the roadmap were the establishment of a list of critical medicines, support for domestic production of some critical medicines, and the importance of EU-wide efforts rather than on a country-by-country basis.

He explained the environment surrounding the pharmaceutical industry in Japan and the causes of supply shortages in Japan, including increased demand for pharmaceuticals, product quality issues, API supply issues, and structural problems in the generic drug industry. During the Q&A session, it became clear that some products in France had had their drug prices raised.

For the first time, a discussion was held with Leem on the topic of Patient Engagement. In this session, both Leem and the Pharmaceutical Manufacturers Association of Japan (PMAJ) presented the position and objectives of the committee in relation to this topic, especially how to promote patient engagement in the healthcare system and drug development, along with specific initiatives. Both sides expressed their sympathy for the importance of dialogue between pharmaceutical companies and patient groups, as well as other stakeholders, to deepen mutual understanding and work together to resolve common issues.

Mr. Shinichi Miura, Chairman of the European and American Subcommittee of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), commented, "We were able to exchange useful information on issues of common interest between Japan and France, including the latest information from both countries. In particular, the reduction of drug costs is not only an issue for each country, but also a common issue that we should consider together in order to promote sustainable innovation in drug discovery for the benefit of patients, which is our goal. Laurence Peyraut of Leem said, "Like my predecessor Mr. Lamoureux, I would like to continue to promote exchanges between France and Japan. I would like to invite you all to Paris in 2024, the year of the Paris Olympics.

This bilateral meeting was also a very fruitful one, as both sides were able to deepen their mutual understanding, and there was a lively exchange of opinions during each session.

( Masahiro Mizobuchi, Team Leader, France Team, Europe Group, Europe and America Subcommittee, International Committee)

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