Topics Held "Regular Meeting with the French Association of the Pharmaceutical Industry (LEEM)
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 activities to resolve international issues in cooperation with governments and pharmaceutical organizations in Europe and North America. The meeting with the LEEM was recently held. The most recent regular meeting with LEEM was held on October 14, 2021 in an online format. Nearly 40 people from both sides participated in the meeting, and a lively exchange of ideas took place. A summary of the meeting is reported below.
Scene of the online meeting
In his opening remarks, Mr. Tatsuya Ito, Chairman of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), stated that the world has entered a new phase due to the COVID-19 pandemic, that the way we work and live has changed dramatically, that the pharmaceutical industry has gained recognition due to rapid clinical trials and approval of vaccines, and that in such a major environment He discussed the importance of learning from each other the best practices of the pharmaceutical industry or individual companies that are helping to solve new healthcare problems post-COVID-19 in the midst of these changes, and of understanding how the digitalization of healthcare, accelerated by COVID-19, will evolve in the future.
In the session that followed, the French Association of the Pharmaceutical Industry (LEEM) spoke about Early access & Compassionate access, which became operational in July 2021, as well as recent topics: the French public-private dialogue, the presidency of the Council of the European Union starting in January 2022, The Digital Health Academy by LEEM was explained as a topic of digital health.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) introduced the "PMAJ Policy Proposal 2021," a summary of the "Pharmaceutical Industry Vision 2021" recently released by the Ministry of Health, Labor and Welfare (MHLW), a statement from the PMAJ, and trends in Digital Health in Japan. The session also included an exchange of views on the French NHI drug price and reimbursement system.
Topics
Assessment Revison and Early Access Reform in France
Director of Economic, Access and Export, LEEM Eric Baseilhac
In this session, the previously complex ATU (Approval for Tentative Use) system was reformed into two simplified schemes: early access (for drugs that pharmaceutical companies intend to commercialize) and compassionate access (for drugs that pharmaceutical companies do not intend to commercialize in the future). The two simplified schemes, early access (for drugs that pharmaceutical companies will commercialize) and compassionate access (for drugs that pharmaceutical companies do not intend to commercialize in the future) were explained in detail. The three goals of the reform in negotiations with the government (simplification of the process, ways to attract more pharmaceutical companies, and sustainability for the authorities), the five criteria in the early access procedure (serious, rare, or disabling diseases, treatments that cannot be postponed, lack of appropriate treatments, high presumption of efficacy and safety, and a high The conditions for pharmaceutical companies to apply, the procedure for early access after marketing authorization, the economic regulation of the process (rebate system), and the conditions and economic regulation for companies applying for compassionate access for drugs for rare diseases were also explained. The session began with a presentation on the COVID-RECOMMENDATIONS.
JPMA Policy Recommendations 2021
Nobuo Murakami, Vice-Chairman, International Committee, Japan Pharmaceutical Manufacturers Association, Inc.
In this session, the current status of COVID-19 in Japan was first introduced. Then, the background and summary of the "Pharmaceutical Manufacturers Association of Japan Policy Proposal 2021," the joint press conference with PhRMA Japan and EFPIA Japan on May 17, 2021, the summary of the "Pharmaceutical Industry Vision 2021" by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical Manufacturers Association of Japan (PSMAJ) statement were presented. The session focused on the French pharmaceutical market and the pharmaceutical industry in Japan.
Interest or Questions of JPMA -Yuji Yahiro, JPMA
Leader, European Group, Europe and America Subcommittee, International Committee of the Pharmaceutical Association of Japan (PAK)
In this session, a total of 11 questions were raised from Japan, mainly about the French drug pricing and reimbursement system, etc. Since early access and compassionate access were already explained in the previous session, the other questions were answered separately, and additional videoconferences were held as necessary. Additional videoconference sessions will be held as needed.
Discussion
The Pharmaceutical Manufacturers Association of Japan (PMAJ) discussed the difference between early access, compassionate access, and nominative ATU and cohort in the past, how the transitional period will be handled, how it will affect products to be applied in the future, and how innovation will be defined in the five criteria for early access. LEEM provided detailed answers to these questions.
The LEEM asked how the image of pharmaceutical companies has changed in Japan as a result of the outbreak of the new coronavirus, and the direction of discussions between the government and the pharmaceutical industry regarding predictability and transparency.
Current Context in France
Strategic Council for Health Industries (CSIS)
General Manager, LEEM Mr. Philippe Lamoureux
During this session, the CSIS (public-private dialogue), to be held in June 2021, was described: the LEEM will work to restore growth, make France the European benchmark for access to innovation, reform the French research ecosystem, provide the resources needed to restore the industry, and forecast the demand for specific skills. President Emmanuel Macron negotiated with the government on five points: to provide and anticipate demand for specific skills; to establish a committee responsible for the development and unification of health policies across ministries under the direct supervision of the Prime Minister to coordinate the governance of a high-level permanent CSIS, He explained that he has pledged very robust measures to reform the research ecosystem, reform towards innovation in patient access, improve the attractiveness and competitiveness of the French industry, and more.
French Presidency of the European Union Q1-Q2 2022
General Manager, LEEM Mr. Philippe Lamoureux
During this session, he introduced France's presidency of the Council of the European Union from January to June 2022. Other priorities included the transition to environmental protection, defense, discussions on the future of Europe, and digital. Regarding digital, health data will be one of the priorities, as it is in France, and regarding health, health union, digital health, and cancer, rare diseases, and drug resistance (AMR) are priorities for the French government, and LEEM, based on the expected agenda, has already increased its contact with stakeholders. It was shared that LEEM is already increasing its contacts with stakeholders based on the envisaged agenda.
Presidency election in May 2022
General Manager, LEEM Mr. Philippe Lamoureux
During this session, the French presidential elections in April 2022 were explained. Trends in public opinion polls and their impact on the pharmaceutical industry were shared.
Discussion
The Pharmaceutical Association of Japan asked questions about the CSIS Commitment to growth, the status of health insurance spending targets under the Social Security Financing Act, LEEM's position and policies on climate change, the Common European Health Technology Assessment (HTA), and AMR measures, which were answered by the LEEM. The LEEM responded to the questions.
Digital Health
LEEM's Digital Health Academy
Ms. Livia Darmon, Digital Project Manager, LEEM
The session introduced the Digital Health Academy, created by the LEEM to support healthcare companies in the digital transformation, which has three pillars: continuous learning in a wide range of therapeutic areas, thematic conferences, and an innovation hub. The Digital Health Academy has three pillars: continuous learning in a wide range of therapeutic areas, thematic conferences, and an innovation hub, and is being implemented as a top priority of the LEEM Digital Commission, bringing together more than 25 pharmaceutical companies. The session was held to discuss the promotion of digitalization in Japan.
Current Status of Japanese Government
Masako Okamoto, Leader, Digital Health Group, Europe and America Subcommittee, International Committee, Pharmaceutical Manufacturers Association of Japan (PMAJ)
This session included an introduction to the government's efforts to promote digitalization in Japan: the mission, vision and four pillars of the newly established Digital Agency in September 2021; the promotion of the My Number Card; the radical reform of the screening of cutting-edge medical devices, such as the program " DASH for SaMD, the status of telemedicine in Japan, and efforts in the field of virtual clinical trials.
Discussion
The Pharmaceutical Association of Japan (PAK) asked questions on the status of the introduction of virtual clinical trials using the telemedicine function compared to pre-Pandemic COVID-19, the future direction of the Innovation Hub at the Digital Health Academy, and the status of therapeutic apps approved in France. Questions were posed and LEEM provided detailed answers.
The LEEM asked questions regarding the protection of personal information in the handling of health data.
Concluding Remarks
Finally, Ms. Sachiko Nakagawa, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), stated that this was the 27th time for the regular meeting with LEEM and that she hoped that the collaboration between the two organizations would be further strengthened in the future during this historic bilateral regular meeting. He also expressed his hope for further fruitful collaboration in several aspects over the next three years, as 2024, when the Olympic and Paralympic Games will be held in Paris, France, will mark the 30th anniversary of this meeting.
The meeting was very fruitful, with active exchanges of views and opinions in each session, and a deepening of mutual understanding among the participants.
The next meeting is scheduled to be held in 2022.
(International Committee, Europe and America Subcommittee, Europe Group)