Topics The "Regular Meeting with the German Association of the Research-based Pharmaceutical Industry (vfa)
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 European and American governments and pharmaceutical organizations. The meeting with the vfa has been held annually. We recently held our regular meeting with vfa on January 31, 2022, in an online format. Approximately 25 people from both sides participated in the meeting and actively exchanged opinions. A summary of the meeting is provided below.
Scene of the online meeting
Introduction
The meeting started with opening remarks by Mr. Tatsuya Ito, Chairman of the International Committee of the Pharmaceutical Manufacturers Association of Japan, and Mr. Harald Zimmer, Senior Manager of International Affairs at vfa. Chair Ito noted that the world has entered a new phase due to the novel coronavirus infection (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 the midst of such a major environmental change the importance of learning from each other about best practices in the pharmaceutical industry that will help solve new healthcare problems post-COVID-19, and understanding how the digitization of healthcare accelerated by COVID-19 will evolve in the future.
In subsequent sessions, vfa gave presentations on Price & Reimbursement/Market Access, Patient Engagement, EU Pharmaceutical Strategy, Digital Health, and Germany's new government.
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, Labour and Welfare (MHLW) and a statement from the PMAJ, the new Japanese government, topics on NHI price reform in FY2022, and digital health.
In each session, a Q&A session was held with both vfa and the Pharmaceutical Manufacturers Association of Japan (PMAJ), and opinions were exchanged on each topic.
Social landscape of Japan
Nobuo Murakami, Vice-Chairman, International Committee, Pharmaceutical Manufacturers Association of Japan
In this session, the vfa introduced the background and summary of the "Pharmaceutical Manufacturers Association of Japan Policy Proposal 2021," the MHLW's "Pharmaceutical Industry Vision 2021," the Statement, the new Japanese administration, and the topic of NHI drug price reform in FY2022.
During the discussion, the vfa asked questions about the status of vaccination and corona vaccination in Japan to date, the command post function of infectious disease control, and the status of generic drugs in Japan, which were answered by the Pharmaceutical Manufacturers Association of Japan (PMAJ).
Social landscape of Germany
Mr. Sebastian Werner and Mr. Eike Melchior
In this session, vfa talked about the recent topics of the price and reimbursement system in Germany, including Reserve Antibiotics as a new market access incentive, the use of Real World Evidence, the EU HTA process and methods, and the new government's The discussion on drug pricing and reimbursement in the new administration and its impact on the market was also explained.
During the discussion, the Pharmaceutical Manufacturers Association of Japan (PMAJ) asked about the points to be discussed with the German government regarding the Joint Clinical Assessment in the EU, mandatory rebates, and support from the government for disease registries in utilizing Real World Evidence, and vfa vfa responded to these questions and provided answers on the current status.
Patient Engagement
vfa Ms. Bettina Benz
The session included an explanation of vfa's patient engagement efforts, the UK Food Standards Agency (FSA) and its Code of Conduct, and the challenges of patient engagement in German healthcare. vfa is actively working with national and international patient groups based on the FSA Code of Conduct. The vfa has a new Patient Collaboration Manager, who is responsible for coordinating corporate involvement in patient think tanks and EUPATI projects, overseeing the Patient Collaboration subcommittee, and managing the vfa's patient portal content. patient portal content operations, etc. On the other hand, he commented that the influence of patient participation in healthcare policy is weak in Germany, and although it is being strengthened, such as the increasing involvement of patient organizations in the G-BA, the highest decision-making body of the German healthcare system, it does not have voting rights, among other issues.
EU Pharmaceutical Strategy
vfa Katja Standke
During this session, the vfa's commitment to the EU Pharmaceutical Strategy was explained, as the most important issue for the vfa is access to medicines, and Germany is the country where access is achieved most quickly after approval by the European Medicines Agency (EMA), He explained that the EU Pharmaceutical Strategy is also working with EFPIA to provide input at the European and national levels to ensure that the Strategy is not negatively impacted. In response to other questions from the Pharmaceutical Manufacturers' Association, the participants answered about the status of the study on the stable supply of medicines at the European level, including Germany's role as the EU Presidency, as well as the current status of the response in Germany.
Digital Health
Masako Okamoto, Leader, Digital Health Group, International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), US/Europe Subcommittee
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.
During the discussion, the Pharmaceutical Association asked about the status of virtual clinical trials in Germany. vfa commented that although the German authorities are not moving quickly, they are starting to make progress, albeit gradually, due to the COVID-19 disaster.
Digital Health
Mr. Tobias Manner-Romberg
This session included an introduction to the status of digital health initiatives in Germany. Digitalization is a top priority for the new German coalition government and is being actively discussed, and that Germany is a pioneer in digital health applications and the European market is trying to follow suit. In addition, the status of discussions on the establishment of a European Health Data Space was shared.
During the discussion, the Pharmaceutical Association asked about the types of data that would be included in the European Health Data Space. vfa commented that it is currently being considered and that it appears that a variety of health-related data will be included, for example, based on data anonymization. The vfa commented that this is currently under consideration and will include various health-related data, for example, based on data anonymization.
Germany's new government
Mr. Ulf Birke
This session included a description of the new government in Germany and its impact on the pharmaceutical industry. The Social Democrats, together with the Greens and the Free Democrats, have formed a three-party coalition government, and the focus on innovation and the health economy, especially the promotion of advanced medicine, is a major challenge as the country faces the fight against pandemics, restoring economic strength, further digitalization, and dealing with demographic and social changes, among others. The Social Democrats and the Greens are the two main parties in the party. The Social Democrats and the Greens have yet to take a clear position on additional indications, drug pricing, and patent protection, and the environment surrounding the pharmaceutical industry is expected to become more difficult in the future. The vfa will continue to work for further improvement of the AMNOG.
Concluding Remarks
Ms. Sachiko Nakagawa, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), spoke about the significance of close cooperation between the PMAJ and the vfa as the new German government takes office, as well as cooperation in preparation for the G7 meetings to be held in Germany and Japan, and the need for more global knowledge exchange to address future medical and welfare issues as digital health and medical and social systems become increasingly important. He concluded by expressing his hope that the Pharmaceutical Manufacturers Association of Japan (PMAJ) and vfa will continue to work together to solve the problems facing patients around the world.
Although the meeting was again held online, there was a lively exchange of ideas and opinions during each session, and the meeting proved to be very meaningful in deepening mutual understanding.
The next meeting is scheduled to be held in 2022.
(International Committee, Europe and America Subcommittee, Europe Group)