Topics The "Regular Meeting with the French Association of the Pharmaceutical Industry (LEEM)
The JPMA International Affairs Committee's Europe & America Subcommittee holds annual 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) as part of its 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, JPMA International Affairs Committee Chairperson Tatsuya Ito noted 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's reputation has been enhanced by the 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.
JPMA introduced the "JPMA Policy Proposal 2021," a summary of the "Pharmaceutical Industry Vision 2021" recently released by the Ministry of Health, Labour and Welfare (MHLW), a statement from JPMA, 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 Chairperson, International Affairs Committee, JPMA
In this session, the current status of COVID-19 in Japan was first introduced. Then, the background and summary of the "JPMA 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 JPMA's statement were presented. The session focused on the French pharmaceutical industry and its role in the pharmaceutical industry.
Interest or Questions of JPMA -Yuji Yahiro, JPMA
Leader, JPMA International Affairs Committee, Europe and America Subcommittee, Europe Group
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
JPMA discussed the difference between early access, compassionate access, and the past nominative ATUs and cohorts, how the transition period is handled, how it will affect products that will be applied in the future, and how innovation is 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), which will take place 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 envisaged agenda, has already increased 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
JPMA asked questions about the CSIS Commitment to growth, the status of health insurance spending targets in 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. healthcare professionals and digital companies beyond healthcare companies.
Current Status of Japanese Government
Masako Okamoto, Leader, Digital Health Group, Europe and America Subcommittee, International Affairs Committee, JPMA
In this session, Ms. Okamoto introduced 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 were shared.
Discussion
The JPMA asked questions regarding the status of virtual clinical trial implementation using the telemedicine functionality 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. The LEEM provided detailed answers to these questions.
LEEM asked about the protection of personal data in the handling of health data.
Concluding Remarks
In closing, JPMA Executive Director Sachiko Nakagawa noted that this is the 27th time that the JPMA and LEEM have met regularly, and that she hopes that the two organizations will continue to strengthen their ties through this historic bilateral meeting, and that since 2024, when the Olympic and Paralympic Games will be held in Paris, France, will mark the 30th anniversary of this meeting, the two organizations would like to further strengthen their ties from several perspectives over the next three years. 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 meaningful, with active exchanges of views and opinions at each session, which helped to deepen mutual understanding.
The next meeting is scheduled to be held in FY2022.
(International Affairs Committee, Europe and America Subcommittee, Europe Group)