Topics Held "Regular Meeting with the Association of the British Pharmaceutical Industry (ABPI)

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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 2022 regular meeting with the ABPI was the first face-to-face (plus online) meeting in three years and was held on November 22, 2022. The meeting with The Japanese Pharmaceutical Group (JPG), an association of Japanese pharmaceutical companies operating in the U.K., was held on the previous day, November 21, and a dinner party was held after the meeting to which Japanese Embassy officials in the U.K. and British government officials were also invited. A total of 47 people from both sides participated in the meeting, and a lively exchange of opinions took place. Here is a summary of the meeting.

Introduction

At the beginning of the meeting, Mr. Richard Torbett, ABPI Chief Executive, welcomed the participants and expressed his pleasure at the opportunity to hold a face-to-face meeting after a long absence. The ABPI will be relocating its offices and the 2023 bilateral meeting will be held at a different location.

The ABPI gave a presentation on market overview and key issue update, genomics, and health data utilization.

The Pharmaceutical Manufacturers Association of Japan (PMAJ) introduced pandemic preparedness, the NHI price revision system, PMAJ activities related to the G7, the action plan for whole genome analysis, and trends toward the utilization of healthcare information.

Richard Torbett talked about the latest trends and challenges in the UK market: since July 2022, UK politics have undergone dizzying changes, but the importance of the life science industry has remained consistent, and there is ongoing collaboration with government officials. All countries are currently facing economic difficulties, and the UK is no different, with increasing pressure on the National Health Service (NHS) to become more efficient, and the biggest challenge is the soaring VPAS1 reimbursement rate. The situation should be corrected by international standards. The company will continue to lobby government officials from several quarters as the burden on companies is too heavy. Other issues introduced in the presentation included the decline in the number of clinical trials in the UK and the maintenance and development of the functions of the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The UK is taking a stronger position on IP protection than ever before in the wake of Brexit, and the country clearly opposed the TRIPS waiver for the new coronavirus vaccine. The ABPI will continue to work with the government in the future. Finally, the various government activities related to pandemic preparedness were shared.

During the Q&A session, the positioning of Life Science Vision as part of future pandemic preparedness was shared. The content of the vision is a long-term strategy agreed upon with the industry to provide various government support measures to help the life science industry achieve results in a wide range of areas, from drug discovery to manufacturing.

First, Dr. Awamura introduced the strategy for strengthening the vaccine development and production system and the emergency approval system as examples of pandemic preparedness in Japan. Subcommittee Chair Kusakai then explained the Ministry of Health, Labour and Welfare's Expert Committee for Fundamental Reform of the NHI Drug Price System and other measures to strengthen drug discovery and eliminate drug lag, and finally, Committee Chair Ito introduced the framework of recommendations for the G7 Hiroshima Summit 2023 Health Agenda.

During the Q&A session, in addition to questions about the incentive system for vaccines and therapeutics for infectious diseases and the Strategic Center for Advanced Research and Development (SCARDA), a comparison of the functions of SCARDA and the Health Security Agency in the UK was suggested as it would be interesting to see how different countries approach public health. Since public health efforts vary from country to country, it would be interesting to compare the functions of SCARDA and the Health Security Agency in the UK. In addition, the participants confirmed and exchanged opinions on the impact of drug price trends in the U.S. and the U.K. on Japan, challenges in eliminating the drug lag, and the Japanese government's stance on intellectual property.

The future prospects for genome infrastructure in the U.K. and Japan were introduced. The UK government has announced a new strategy called "Genome UK" for 2020, clearly stating that it will work on three areas: "diagnosis and personalized medicine," "prevention," and "research. Three well-known genomics programs in the UK are UK Biobank, Genomics England, and Our Future Health. Researchers in more than 100 countries use data from UK Biobank, and the UK's Welcome Sanger While we are excited about the growing role of the UK in the field of genomics, including the fact that researchers in more than 100 countries use UK Biobank data, and that the UK's Welcome Sanger Institute made a significant contribution during the pandemic by providing 20% of the SARS-CoV-2 genome sequence to the world, we are also concerned about the need to improve genomic medical services and ensure that patients have equal access to genomic information. On the other hand, he also introduced the issue of the need for education and training for medical professionals in order to promote the improvement of genomic medical services and to ensure that patients have equal access to genomic information.

In Japan, the Ministry of Health, Labour and Welfare (MHLW) is taking the initiative in the "Whole Genome Analysis and Other Action Plan," and the "Action Plan 2022" was formulated in September 2022.

He introduced the establishment of an organization responsible for the operation of the project and the construction of a system that enables industry to take advantage of the project, referring to Genomics England, and that approximately 15,700 cancer cases and 8,000 cases of intractable diseases have been analyzed in the past, with the plan to proceed with the analysis of 100,000 genomes in the future.

The Pharmaceutical Manufacturers Association of Japan (PMAJ) has been requesting the government to provide an environment for the collection of rich clinical information, the storage of omics information, and a highly convenient analysis environment so that the genome infrastructure can be used for drug discovery.

The ABPI introduced a report on health data in the U.K. available to researchers in the pharmaceutical industry, which will be released in May 2022, and the five basic principles for using health data in research. As for government initiatives, there was an introduction to the latest topics, including the Health Data Strategy announced by the NHS in the UK in June 2022.

The Pharmaceutical Manufacturers Association explained the current status of Japan's health and medical data infrastructure and its utilization, as well as the government's policy on medical DX, which is included in the "Kotto Policy 2022. He also introduced the "Pharmaceutical Association of Japan Policy Proposal 2023," which is scheduled to be released in 2023, and will include a request for the formulation of a comprehensive policy that will focus on both the establishment of a health and medical data infrastructure and legislation for the protection of personal information.

Concluding Remarks

Sachiko Nakagawa, Executive Director of the Pharmaceutical Manufacturers Association of Japan (PMAJ), thanked the participants for exchanging information on a wide range of topics, including data strategy and genomics England, and expressed her hope for continued cooperation to resolve common issues related to the pharmaceutical industry.

The active exchange of views and opinions during each session deepened mutual understanding and made the meeting extremely meaningful. The next meeting is scheduled to be held in 2023.

(Ms. Kyoko Nakano, Leader, Europe Group UK Team, Europe and North America Subcommittee, International Committee)

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