(Report) “UK Workshop on Health and Medical Innovation, Regulatory Science”
date : 5/22/2014
On April 1st, 2014 (Tuesday), Health and Global Policy Institute (HGPI) held the “UK Workshop on Health and Medical Innovation, Regulatory Science” at the Embassy of Japan in the United Kingdom.
In Japan, the financial burden on citizens has increased due to an aging population and a declining birthrate. Authorities must rethink the domestic welfare and healthcare system to ensure its sustainability in the long run.The Abe administration has been aiming to develop regenerative medicine and medical IT. There are many commonalities between Japan and the Untied Kingdom. This workshop was co-organized by HGPI and the embassy of the United Kingdom to focus on medical innovation between Japan and the United Kingdom and discussed policies needed to promote such innovations.
■Schedule of the day：
14:00-14:05 Opening Remarks: The Embassy of Japan
14:05-14:15 Introduction: Japanese Healthcare Innovation Strategy
-Dr. Toshio Miyata Executive Director, HGPI
Special Advisor to the Cabinet, Japan Government
Session 1: Health and Medical Innovation and Drug Access
-Dr. Masuhiro Kato (Professor, the University of Tokyo)
Open-Innovation in Pharmaceutical R&D
-Mr. Takashi Takenoshita (CEO, Shionogi Limited)
The Challenges of the Pharmaceutical Industry
-Dr. Yasuhiro Fujiwara (Director-General, Strategic Planning Bureau, National Cancer Center in Japan)
The Challenge of Access of Anti-Cancer Agents
-Dr. Francesco Pignatti (Head of Oncology, Hematology and Diagnostics, EMA)
Recent Review and Future Perspective of Anti-Cancer Agents
Session 2: Regulatory Science and R&D Ecosystem
-Dr. Junko Sato (MHLW/PMDA liaison official, EMA)
Regulatory Science Initiative and the Partnership between EMA and PMDA
-Dr. Nadeem Sarwar (VP and Head, Genetics & Human Biology, Eisai Inc.)
Genome and Clinical IT Big Data
-Dr. Yo Nakajima (Chief Technology Officer for Information Business Sector, Hitachi Europe Ltd.)
New Health Care IT Project with UK NHS and Hitachi
-Dr. Shin-ichi Ohnuma (Chair in Experimental Ophthalmology, University College London)
The Future of Collaboration between Japan and UK in Translational Research
-Dr. Bob Clay (VP global regulatory affairs, AstraZeneca)
The Regulatory Science of Anti-Cancer Agents
Session 3: Summary Discussion
Facilitator: The Embassy of Japan
■Discussion of the day：
The embassy of Japan in United Kingdom made the opening remarks followed by Dr. Toshio Miyata’s (Executive director/ Health policy unit leader, HGPI) comment on Japanese healthcare innovation strategies and modern regulatory reforms. Dr. Miyata also mentioned the lack of industry collaboration within both Japan and the United Kingdom in comparison to that of the United States..
Session one was conducted under the theme of health and medical innovation and drug access. In this session, Dr. Masahiro Kato (Professor, University of Tokyo), Mr. Takashi Tekenoshita (CEO, Shionogi Limited), Dr. Tasuhiro Fujiwara (Director-general, Strategic Planning Bureau), and Dr. Francesco Pignatti (Head of Oncology, Hematology and Diagnostics, EMA) participated to review medically related policies and to discuss future prospects of related fields.
Dr. Kato talked about how research and development had stagnated over 60 years. He also explained the importance of open innovation in medical research and development. Dr. Kato introduced examples of open innovation utilizing external groups’ ability for development and evolutionary growth through a series of patents. He also talked about pharmaceutical companies that work with Universities and bio-ventures, another example of open innovation. It created a great opportunity to consider future prospects of research and development for both Japan and the United Kingdom.
Mr. Takenoshita presented about the Japanese tax system and introduced health technology assessment as an incentive to attract pharmaceutical Industries. Mr. Takenoshita pointed out that there are few benefits in keeping industries in Japan since tax for research and development became more strict for Japanese pharmaceutical industries and the gap between International Financial Reporting Standards (IFRS) and Japanese Generally Accepted Accounting Principles (J-GAAP) has widened. He also introduced the patent box tax system and discussed the challenges within the Japanese tax system. Then, he explained the challenges and possible strategies in introducing health technology assessment and any future possibilities for Japan to take leadership in introducing such a system.
Dr. Fujiwara talked about access to anticancer drugs. He introduced how to facilitate access to advanced medicine and medical devices,and then continued to explain the relationship between pharmaceutical approval and insurance coverage. Dr. Fujiwara mentioned that the process of improving access to medical goods should be based on more discussions which include all stakeholders, such as patients, insured persons, medical practitioners, and regulatory agencies, since this issue is highly relevant to them.
Dr. Pignatti presented trends of anticancer drugs and held a discussion about the progression free survival period and clinical endpoint (occurrence of a disease, symptom, sign or laboratory abnormality that constitutes one of the target outcomes of the trial) as applications for approval. He also addressed several issues about licensing and anti-cancer drugs by presenting current examples. Then Dr. Pignatti talked about future prospects for acquiring anti-cancer drugs in the early stages of disease progression.
Session two was held under the theme of regulatory science R&D ecosystem; Dr. Junko Sato (Ministry of Health, Labour and welfare/PMDS liaison official, EMA), Dr. Nadeem Sarwar (VP and Head, Genetics & Human Biology, Eisai Inc.), Dr. Nakajima Yo (Chief Technology officer for Information Business Sector Hitachi Europe Ltd.), Dr. Shin-ichi Ohnuma (Chair in Experimental Ophthalmology, University College London) Dr. Bob Clay (VP global regulatory affairs, AstraZeneka) participated and deepened the understanding of regulatory science, research and development (R&D), and the ecosystem of the pharmaceutical industries.
Dr. Sato introduced the leadership of regulatory science by EMA and PMDA and its partnership. She emphasized the importance of progressing a prompt service system to provide medical devices and other goods, through collaboration with other countries, by utilizing the information from the assessment report, website, and information about Japanese pharmacopoeia accessible in English.
Dr. Sarwar introduced the human genome and discussed the importance of utilizing clinical big data. He explained current advancement in this field, including the discovery of new molecular target drugs and personalized medicine, a result of the use of big data about genotype and phenotype collected from all over the world and the development of gene expression analysis.
Dr. Nakajima presented a health care project that integrated the United Kingdom’s NHS (National Health Service) and Hitachi’s IT technology. After Mr. Nakajima briefly explained about the main projects of Hitachi’s Europe branch office, he presented a diabetes project, notable for its high cost performance, taken place in Manchester and other such projects in collaboration with the NHS.
Dr. Ohnuma talked about future prospects of the United Kingdom and Japan’s collaboration in transnational research. Dr. Ohnuma explained the importance of knowhow transfer, cost/time reduction, and of collaboration while pointing out the lack of joint investment in financial resource allocation for translational research and the decreasing number of Japanese students and researchers studying and learning abroad. Finally,, Dr. Ohnuma promulgated an idealistic model for future collaboration.
Dr. Bob Clay introduced several examples of licensing, the expectation from cancer medication authorization, and the EMA Pilot project.
A Panel discussion was held based on the discussion in the first session and the second session, facilitated by the embassy of Japan in the United Kingdom. The active discussion involved how to utilize the know-how of both the United Kingdom and Japan. After the panel discussion, a networking opportunity was held to accelerate further medical innovation between the United Kingdom and Japan.
* European Medical Agency (EMA) refers to the European Union regulatory agency for medical goods