30 October 2017
EFPIA Japan

EFPIA Japan institutes MSL guideline for the purpose of sharing
the common understanding among HCP and other stakeholders
as to MSLs’ role and activities
TOKYO—30 October 2017— EFPIA Japan announced today that MSL guideline has
been instituted for members of EFPIA Japan.
(http://www.efpia.jp/link/Final_EFPIA_MSL_Guideline_201710_E.pdf)
Recently, many pharmaceutical companies started to employ individuals who primarily
undertake information exchange with healthcare professionals from the medical,
pharmaceutical and other scientific perspectives in a department independent from thedepartments conducting the sales activities of drugs. These individuals are called as“Medical Science Liaisons (MSL)”.
In the Japanese pharmaceutical industry, a system has been established for assigningpersonnel called “Medical Representative (MR)”, who have been undertaking the sales
activities of his/her company’s own drugs, post-marketing safety control, post-marketingsurveillance, etc. With a focus on these activities, the self-regulations have been
implemented on pharmaceutical companies’ promotion activities targeting healthcare
professionals, medical institutions, etc.
On the other hand, except regulations pertaining to clinical trials and studies, no public orself-regulations have been established concerning information exchange aimed at theresearch and development of drugs with healthcare professionals, etc., or concerning thecollection, provision and exchange of information aimed at the accumulation of advanced
medical and pharmaceutical knowledge concerning existing drugs.
Therefore, in the actual medical/clinical practice, there were some cases where thefairness and transparency could be hardly secured, because all activities wereassessed/judged in the framework of the codes and regulations governing promotion
activities, or, for the activities never fitting into such framework, they wereassessed/judged simply by each person involved on case-by-case basis.
Given this situation, EFPIA-J published the “Principal regarding MSL’s Roles andActivities” (“Principal”) in October of 2015 for the purpose of sharing the common
understanding among HCP and other stakeholders. In order to advance the Principal,
hereby establishes an MSL Guideline as a reference for each pharmaceutical company toinstitute their own guideline.
__________________________________________________________________EFPIA Japan Office
Marunouchi Kitaguchi Bldg., 6-5, Marunouchi 1-chome, Chiyoda-ku, Tokyo 100-8265
Tel: +81-3-6301-3066 Fax: +81-3-6301-3060

Ole Mølskov Bech, Chairman of EFPIA Japan said: “It is crucial that the pharmaceuticalindustry is able to engage healthcare professionals in discussion about the research anddevelopment of new drugs and about post-marketing safety controls – but society musthave confidence that these discussions are appropriate. The EFPIA MSL Guideline will
help create that confidence. In doing so, it will contribute to advances in treatments, andwill ultimately benefit patients who suffer from disease. By providing a practical guidelinethat defines the role of MSLs, EFPIA Japan will contribute to patients and to scientificdevelopment in Japan”###About EFPIA Japan:
Established in April 2002, EFPIA Japan represents 24 R&D-based European
pharmaceutical companies operating in Japan. In 2016, combined sales from the member
companies accounted for roughly 22% of the pharmaceutical market in Japan.
Mission of EFPIA Japan is to “Contribute to healthcare and patients in Japan by early
introduction of innovative medicines and vaccines”. EFPIA Japan aims to strengthen
dialogue with decision-makers in order to improve Japanese healthcare for all.
Inquiries to:
Noriko Okazaki, Committee Chair, Public Relations Committee, EFPIA Japan
Novo Nordisk Pharma Ltd.
2-1-1 Marunouchi, Chiyoda-ku, Tokyo 100-0005
TEL: 080-3508-3251
Mail: no@novonordisk.com
Tetsu Owari, Committee Vice Chair, Public Relations Committee, EFPIA Japan
Boehringer Ingelheim Japan, Inc.
ThinkPark Tower 2-1-1 Osaki, Shinagawa-ku, Tokyo 141-6017
TEL: 03-6417-2223
Mail : tetsuya.owari@boehringer-ingelheim.com

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