Topics The "Regular Meeting with the Association of the British Pharmaceutical Industry (ABPI)" was held.
The JPMA International Affairs Committee's European & American Subcommittee holds annual meetings with the European Federation of Pharmaceutical Industries and Associations (EFPIA), the British Association of the 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 European and American governments and pharmaceutical organizations. 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 JPMA International Affairs Committee Chairperson Tatsuya Ito and ABPI Chief Executive Richard Torbett. Chairperson 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 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 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 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, and statements from the JPMA, Patient Engagement, and Digital Health.
Each session was followed by a Q&A session with both the ABPI and JPMA to exchange views on the respective topics.
UK Market Overview
Government Life Science Vision / Brexit / COVID
Mr. Richard Torbett, Chief Executive, ABPI
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 JPMA asked about the impact on genomic medicine in the U.K. of the promotion of the use of genomic data, which is included in the Life Science Vision and has been actively promoted in the U.K., and it was shared that while investment in R&D has been enhanced, diagnostic use 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
JPMA International Affairs Committee, US/Europe Subcommittee, Chairperson Mr. Shinichi Miura
In this session, the background and summary of the "JPMA Policy Recommendation 2021," the "Pharmaceutical Industry Vision 2021" of the Ministry of Health, Labour and Welfare, 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 JPMA responded that Key Performance Indicators (KPIs) were set in the "Pharmaceutical Industry Vision 2021," and that these KPIs should be monitored at the practitioner level. The Pharmaceutical Manufacturers Association of Japan (PMAJ) responded that Key Performance Indicators (KPIs) had been established in the "Pharmaceutical Industry Vision 2021" and that they would monitor them at the working level while promoting public-private dialogue.
Patient Engagement
Mr. Colette Goldrick, Executive Director Strategy, Research and Partnerships, ABPI
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 JPMA asked about guidelines developed in cooperation with patient groups and Transparency Guideline between companies and patient groups, and the ABPI introduced these guidelines and their links. The JPMA also asked about collaboration with patient groups outside of the UK and global patient groups and how this is done. The ABPI responded that currently they are concentrating on the UK, but will collaborate with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and others for activities at the global level.
Patient Engagement
Ms. Asako Morimoto, JPMA International Affairs Committee, Europe and America Subcommittee, Europe Group
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 JPMA. 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 also highlighted the JPMA's Guidelines on Collaboration with Patient Groups and Transparency Guideline on the Relationship between Corporate Activities and Patient Groups, and commented that it was very encouraging to see similar initiatives underway in the UK.
Digital Health
Ms. Colette Goldrick, Executive Director Strategy, Research and Partnerships, ABPI
Masako Okamoto, Leader, Digital Health Group, European and American Subcommittees, 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.
In the discussion, JPMA introduced the status of the introduction of virtual clinical trials by using the telemedicine function compared to the pre-pandemic COVID-19, and ABPI introduced the efforts to build a medical data infrastructure through public-private partnership and a roadmap to build social trust in 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 JPMA asked whether public awareness of the importance of building social trust has changed as a result of their activities, to which the JPMA responded that they are just at the beginning of the process and would like to confirm this over time, He commented that it will be 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, Mr. David Watson, ABPI
This session included additional questions and answers to questions that the JPMA had posed to the ABPI in advance of the meeting. The JPMA asked about new issues regarding pricing and reimbursement for high-cost treatments and the introduction of a new system of processes and methods for rapid and fair access to medicines and medical devices, as advocated by the National Institute for Health and Care Excellence (NICE) in the UK, and the ABPI provided detailed explanations. The ABPI provided a detailed Explanation.
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, JPMA Executive Director Sachiko Nakagawa stated that in the post-Corona era, with the increasing importance of digital health and the review of medical and social systems, there is a need to discuss and exchange knowledge and experiences on a global scale, and JPMA would like to work together with the ABPI to resolve issues surrounding patients worldwide. The Pharmaceutical Manufacturers Association of Japan (PMAJ) would like to work together with the ABPI to resolve the issues surrounding patients around the world.
Although the meeting was again held online, there was a lively exchange of opinions in each session, and the meeting was very meaningful in that we were able to deepen our mutual understanding.
The next meeting is scheduled to be held in FY2022.
(International Affairs Committee, Europe and America Subcommittee, Europe Group)