Topics Held "Regular Meeting with the Association of the British Pharmaceutical Industry (ABPI)
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 is held every year. We recently held our regular meeting with the ABPI on December 9, 2021 in an online format. A total of nearly 35 participants from both sides joined the meeting and had a lively exchange of ideas. 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. Richard Torbett, Chief Executive of ABPI. Mr. Ito explained that the world has entered a new phase due to the new coronavirus pandemic (COVID-19), 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 drastic change in the environment, the pharmaceutical industry is now in a new phase of development after COVID-19. 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 of understanding how the digitalization of healthcare, accelerated by COVID-19, will evolve in the future.
In the session that followed, ABPI presented on UK Market Overview, Patient Engagement, Digital Health, and UK pricing and market access Q&A.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) presented 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 statements from the PMAJ on Patient Engagement and Digital Health.
Each session was followed by a Q&A session with both the ABPI and the Pharmaceutical Manufacturers Association of Japan (PMAJ) to exchange views on the respective topics.
UK Market Overview
Government Life Science Vision/Brexit/COVID
Chief Executive, ABPI Richard Torbett
Three important topics in the UK market were introduced during this session
1) Life Science Vision
The UK government has announced a new vision for the life science sector, based in part on lessons learned from COVID-19. One very important element compared to the previous vision is the positioning of the UK's National Health Service (NHS) as an industry partner.
2) Remaining issues regarding BREXIT
The conclusion of a UK-EU Mutual Recognition Agreement (MRA) for batch testing and the resolution of complex regulatory issues in Northern Ireland remain top priorities for the industry.
3) Global issues related to COVID-19 and UK position
The UK has maintained its position against the TRIPS Waiver proposal (waiver of COVID-19 related intellectual property) at the World Trade Organization (WTO). In addition, the G7, which held the 2021 Presidency, launched a 100 Days Mission for the rapid development and supply of vaccines and therapeutics to prepare for future pandemics.
During the discussion, the Pharmaceutical Manufacturers' Association asked about the impact of the promotion of genome data utilization, which is included in the Life Science Vision and has been actively promoted in the U.K., on genomic medicine in the U.K. It was shared that while R&D investment has been enhanced, diagnostic utilization has not progressed. The question was raised about the impact of the promotion of the use of genome data, which has been actively promoted in the UK, on genome medicine in the UK.
Japanese Government Pharma Industry Vision
International Committee of the Pharmaceutical Consortium of Japan (PPCJ), Europe/US Subcommittee Chairman: Shinichi Miura
In this session, the background and summary of the "Pharmaceutical Manufacturers Association of Japan (PMAJ) Policy Recommendation 2021," the "Pharmaceutical Industry Vision 2021" of the Ministry of Health, Labour and Welfare (MHLW), and the Statement were introduced.
During the discussion, the ABPI asked how much the government is willing to cooperate with the pharmaceutical industry, and the Pharmaceutical Manufacturers Association of Japan (PMAJ) responded that Key Performance Indicators (KPIs) are set in the "Pharmaceutical Industry Vision 2021," and that they are to be monitored at the practitioner level. The Pharmaceutical Manufacturers Association of Japan (PMAJ) responded that Key Performance Indicators (KPIs) have been set in the "Pharmaceutical Industry Vision 2021" and that they will monitor them at the working level while promoting public-private dialogue.
Patient Engagement
Executive Director Strategy, Research and Partnerships, ABPI Colette Goldrick
In this session, the ABPI's Patient Engagement initiative was explained, and the strategy, which was reviewed in the first quarter of 2021, includes four elements: incorporating patient input into leadership decision-making, placing patient engagement at the center of the agenda, and collaboration. The strategy also included the establishment of a Patient Advisory Committee, patient involvement in the association's campaigns, updated collaborative guidance, and the initiation of programs to embed patient engagement in all aspects of the association's work. The Pharmaceutical Manufacturers Association of Japan (PMAJ) was introduced to these efforts.
During the discussion, the Pharmaceutical Manufacturers' Association asked about guidelines developed in cooperation with patient groups and transparency guidelines between companies and patient groups, and the ABPI introduced these guidelines and the links to them. The ABPI responded that they are currently concentrating on the UK, but will work with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and others on a global level.
Patient Engagement
Ms. Asako Morimoto, Member, Europe Group, Europe and America Subcommittee, International Committee, Pharmaceutical Manufacturers Association of Japan (PMAJ)
In this session, the speaker explained trends in Japan regarding Patient Engagement, focusing on the efforts of the Pharmaceuticals and Medical Devices Agency (PMDA) and the Pharmaceutical Manufacturers Association of Japan (PMAJ). Although the U.S. and Europe are far ahead of Japan, the PMDA has been accelerating its efforts in recent years. The PMDA has established a Patient Centricity Working Group and gave a detailed introduction of the Patient Engagement Guidance it issued in 2021. The ABPI commented that similar efforts are underway in the U.K. and that the presentation was very encouraging.
Digital Health
Ms. Colette Goldrick, Executive Director Strategy, Research and Partnerships, ABPI
Masako Okamoto, Leader, Digital Health Group, European and American Subcommittees, International Committee, Japan Pharmaceutical Manufacturers Association (JPMA)
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.
In the discussion, the Pharmaceutical Manufacturers Association of Japan (PMAJ) introduced the status of the introduction of virtual clinical trials by using the telemedicine function of COVID-19 compared to the pre-pandemic period, and ABPI introduced its efforts to build a medical data infrastructure through public-private partnerships and its roadmap for building social trust regarding the use of medical data. The Pharmaceutical Manufacturers Association of Japan (PMAJ) presented a roadmap for building social trust in the use of medical data.
The Pharmaceutical Manufacturers Association of Japan (PMAJ) asked whether public awareness of the importance of building social trust has changed as a result of the activities, to which the PMAJ responded that it is just at the beginning of the process and would like to confirm this over time, He commented that it is important to provide support for patients with digital literacy issues, such as the elderly.
UK pricing and market access Q&A
Executive Director, Patient Access, ABPI Mr. David Watson
During this session, additional questions and answers were provided by the Pharmaceutical Manufacturers Association to the ABPI regarding the answers to the questions they had posed to the ABPI in advance of the session. The Pharmaceutical Manufacturers' Association asked about new issues regarding pricing and reimbursement for high-cost treatments and the introduction of a new system for rapid and fair access to medicines and medical devices, as advocated by the National Institute for Health and Care Excellence (NICE) in the United Kingdom. The ABPI provided detailed explanations.
Concluding Remarks
Other discussions also took up the ABPI's work on climate change, a hot topic. Both sides confirmed that information sharing will be a priority in the future. In closing, Ms. Sachiko Nakagawa, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), stated that in the post-Corona era, with the increasing importance of digital health and the review of medical and social systems, it is necessary to discuss and exchange knowledge and experiences on a global scale, and that PMAJ would like to work together with the ABPI to resolve issues surrounding patients worldwide. The Pharmaceutical Manufacturers Association of Japan (PMAJ) is committed to working together with the ABPI to resolve the challenges facing patients around the world.
Although the meeting was again held online, there was a lively exchange of views and opinions at each session, which was very useful in deepening mutual understanding.
The next meeting is scheduled to be held in 2022.
(International Committee, Europe and America Subcommittee, Europe Group)