October 2015
EFPIA-Japan
Corporate Ethics Committee
The positioning and activity principles of MSL（Revised by CEC, October 29, 2015）－Introduction－
More and more pharmaceutical companies in Japan are now starting to have MedicalAffairs (hereinafter referred to as MA) or Medical Science Liaison (hereinafter referredto as MSL) teams in place. Multinational pharmaceutical companies are growing theMSL function to enhance information provision for Healthcare Professionals (HCPs)
while domestic ones are following similar trends. In reality, however, the requirements
for MSL are not necessarily the same for all the companies. Given this background, theCorporate Ethics Committee has decided to establish the positioning and the activity
principles to share the basic stance on how MSLs should be.
1．The background and history of MA and MSL
Pharmaceutical products demonstrate their value only when they are properly used
for patients in need of treatment. There is therefore a need to provide efficacy and safety
information in a balanced manner; communicating this information appropriately withHCPs will be of benefit to patients.
Information on pharmaceutical products can come from information gained during
investigational clinical trials, and also come from medical needs analyses based on ahuge amount of prescribing information obtained from post-launch clinical studies andclinical practice. It is becoming increasingly important to provide this latest information
to HCPs when they judge the benefits and risks of pharmaceutical products for theirpatients.
Given this background, pharmaceutical companies have created Medical Affairs (MA)functions and the Medical Science Liaison (MSL) role, consisting of employees who havea high level medical and scientific expertise. MA and MSLs help advance healthcare bycompiling higher quality drug information and delivering it to HCPs in a timelymanner.
2．The positioning and role of MA and MSL
The role of MA is to generate evidence based on medical needs, communicate
information with internal stakeholders, and provide scientific support for thepreparation of materials used for information provision while MSLs actually interact
with HCPs for such activities.
■About MA
The MA function is independent of Commercial activities (Sales, Marketing), andengages in non-promotional scientific activities. Staff members who belong to MA havemedical and scientific expertise, and provide medical and scientific support for disease
prevention, treatment and diagnosis etc. through Medical activity plan development,
product data and evidence accumulation, and scientific exchange with HCPs. Theseactivities are not influenced by Commercial functions.
■About MSL
The MA function often has MSL roles, who generate information described above andinteract with HCPs. MSLs are appointed from those who have taken training based on acurriculum to acquire advanced scientific knowledge and skills appropriate for scientificexchange with HCPs. They are required to attend continuous training to acquire
further expertise after their appointment. MSLs are not evaluated with commercial
factors including sales and market share etc.
As described above, MA and MSL activities will be closely associated with the lifecycleof pharmaceutical products and greatly help maximize their medical and scientificvalue.
3．MSL activity principles
CEC has developed the following “MSL activity principles” based on the positioning androle described in 2:（1）MSLs visit specialists in each disease area, build/ maintain sound and good
relations of trust while respecting the independence of HCPs, and havesubstantial discussion.
（2）MSLs provide accurate, objective, and scientific data based information in a
non-biased manner.
（3）Information on off-label use or unapproved drugs should only be given reactively inresponse to a question or request from an HCP.
（4）MSL activities are not for sales promotion, and information to be provided does notcontain sales messages.

（5）MSLs engage in activities in accordance with Medical plans that are notassociated with sales or market share etc.

（6）In principle, when MSLs provide information with HCPs from a medical/
scientific perspective or exchange information with HCPs, they should not sit
with MRs.
（ 7 ） MSLs do not share the details of providing information with MRs from acommercial perspective.
END