EFPIA Japan MSL Guideline Ver.01 (Translation)

EFPIA Japan MSL Guideline (Translation)
Table of Contents
Preamble
1. General Provisions
2. Definitions
3. Purposes and Responsibilities of MSLs
4. Responsibilities of Pharmaceutical Companies Employing MSLs
5. Enhancement of Awareness, Information Collection and Opinion Exchange
regarding diseases
6. Provision of Information and Exchange of Opinions concerning his/herCompany’s Own Drugs
7. Advisory Board
8. Seminars and Other Events
9. Studies concerning Drugs
Preamble
In consideration of the nature of pharmaceutical companies conducting their business activities
under the public medical insurance system as a part of human life-related industry, pharmaceuticalcompanies (i), by being well-aware of sublime ethic, have to comply with the Law concerning
Securement, Etc. of Quality, Efficacy and Safety of Pharmaceutical Drugs and Medical Devices, Etc.
(“PAL”), the Act on Prohibition of Private Monopolization and Maintenance of Fair Trade , otherapplicable laws and regulations, and the Fair Competition Code inEthical Pharmaceutical Drugs

Marketing Industry , the JPMA Code of Practice, and other self-regulations established by otherpharmaceutical industrial associations, (ii) contribute to the improvement of people’s health andwelfare in Japan and other parts of the world through the development of innovative, highly usefuland safer drugs, and the dissemination activities and, for this purpose, pharmaceutical companies have
responsibilities (a) to appropriately exchange information with healthcare professionals (“HCP” asdefined in the paragraph 2 “Definition” below), medical institutions, patient groups and otherstakeholders, (b) to work for researches and developments to satisfy unmet medical needs, and (c) tocollect and provide information concerning the proper use and dissemination of drugs.
In the Japanese pharmaceutical industry, a system has been established for assigning personnel
called “Medical Representative” (“MR”), who have been undertaking the sales activities of his/hercompany’s own drugs, post-marketing safety control, post-marketing surveillance, etc.

With a focus

on these activities, the self-regulations have been implemented on pharmaceutical companies’

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promotion activities targeting healthcare professionals, medical institutions, etc. On the other hand,
except regulations pertaining to clinical trials and studies, no public or self-regulations have been
established concerning information exchange aimed at the research and development of drugs withhealthcare professionals, etc., or concerning the collection, 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 the fairness andtransparency could be hardly secured, because all activities were assessed/judged in the framework of
the codes and regulations governing promotion activities, or, for the activities never fitting into suchframework, they were assessed/judged simply by each person involved on case-by-case basis.
Recently, many pharmaceutical companies started to employ individuals who primarily undertake
information exchange with HCP, etc. from the medical, pharmaceutical and other scientificperspectives in a department independent from the departments conducting the sales activities of drugs.
These individuals are called as “Medical Science Liaisons” (“MSL”).

Given this situation, EFPIA-J published the “Principal regarding MSL’s Roles and Activities” (“Principal”) in October of 2015 forthe purpose of sharing the common understanding among HCP and other stakeholders.

In order toadvance the Principal, hereby establishes an MSL Guideline (“Guideline”) as follows.

1.

General Provisions
The Guideline summarizes the items which each pharmaceutical company should take into

consideration when MSL, who belongs to a department independent from the departments conducting
the sales activities of drugs, appropriately exchange information with HCP, medical institutions,patient groups and other stakeholders, respond to unmet medical needs, facilitate the proper use ofdrugs, and collect and provide information for facilitating the optimization of product value.
Therefore, this Guideline does not intend to refer to any activities of pharmaceutical company’s
employees other than MSL.

2.

Definitions
Pharmaceutical companies“Pharmaceutical Companies” refers to companies that hold drug marketing authorization underArticle 12 of the PAL, and that currently engage in manufacturing/marketing orimporting/marketing ethical drugs.
HCP (Healthcare Professionals)“HCP” refers to medical doctors, dentists, pharmacists, nurses, etc., who engage in a
medical/pharmaceutical research and/or medical services.

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EFPIA Japan MSL Guideline Ver.01 (Translation)

KOL (Key Opinion Leader)“KOL” refers to HCP, who have plenty of clinical experience and advanced academic knowledge
in the respective specialized areas.
Unmet Medical Needs“Unmet Medical Needs” refers to medical needs which have yet to be satisfied.
Sales Activities“Sales Activities” refers to activities of inducing HCP’s proper prescription of company’s own
products (defined below) and drive the sales of such drug in order to make available such drug topatients.
Proactive Information Provision“Proactive Information Provision” refers to proactively providing information without any requestfrom HCP.
Reactive Information Provision“Reactive Information Provision” refers to providing information in response to a voluntary requestfrom HCP.
Advisory Board“Advisory Board” refers to a meeting held for the purpose of receiving specialized information andprofessional advice from an appropriate number (one or more) of KOL or other stakeholder(s)engaging in each specialized area.
Medical Plan

“Medical Plan” refers to a plan necessary for maximizing the contribution of drugs’ value to
medical treatment and each specific activity to realize such plan.

Such plan and conducting suchactivity shall not be affected by Commercial departments.
Medical Seminar“Medical Seminar” refers to a seminar or an event planned and held by a company from a medical,
pharmaceutical, or other scientific perspective and “not for the purpose of sales”, and is not affectedby departments engaging in Sales Activities.
Regarding the Company’s Own Products“Regarding the company’s own products” refers to matters concerning the efficacy, safety andquality of the company’s own products, as well as matters concerning medical treatment for therelevant disease by said products.

3.

Purposes and Responsibilities of MSL
1)

MSL identifies and verifies potential unmet medical needs for drugs and appropriate standard
treatments from the medial, pharmaceutical and scientific perspectives and conducts activities
for the purpose to maximally contribute to the medical treatment with the value of drug.

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EFPIA Japan MSL Guideline Ver.01 (Translation)

2)

MSL must satisfy the qualifications specified by his/her company.

3)

MSL must belong to a department independent from the departments engaging in the Sales
Activities of his/her company’s own products.

4)

MSL must not be reviewed/evaluated based on the sales revenue of his/her company’s ownproducts.

5)

MSL must take continuous education by taking the educational opportunities provided by
his/her company and/or by external organizations in accordance with his/her company’s rule.

4.

Responsibilities of Pharmaceutical Companies Employing MSL
1)

A pharmaceutical company must specify the responsibilities of its MSL.

2)

Since MSL is required to provide and exchange opinions to or with KOL and otherstakeholders from medical, pharmaceutical and other scientific perspectives, thequalifications of MSL has to be so specified as to enable each pharmaceutical company toselect individuals who have a sufficient sense of ethics required to play a part of healthcare aswell as adequate knowledge and capability.

3)

A pharmaceutical company must not review/evaluate MSL based on the sales revenue of
his/her company’s own products.

4)

5.

A pharmaceutical company must provide the opportunity of continuous education to MSL.

Enhancement of Awareness, Information Collection and Opinion Exchange regarding
DiseaseWith relation to the disease areas of his/her company’s own products and drugs that his/her company
plans to market in the future, MSL may enhance disease awareness collect and provide information,and exchange opinions from, to and with HCP, patients and other stakeholders from the medical,
pharmaceutical and other scientific perspectives.

6.

Provision of Information and Exchange of Opinions concerning Drugs
1)

MSL must not engage in any Sales Activities of his/her company’s own products.

2)

MSL act to perform the responsibilities which are different from the ones to be taken by thedepartments engaging in Sales Activities. In order to avoid any misunderstanding that MSL
engages in the Sales Activities, in principal, MR shall not be present when MSL provides
information to, or exchanges information with, HCP.

3)

MSL may occasionally exchange information with MR regarding the collection and provisionof safety information or the treatment measures of the relevant HCP, however, any details of
information provided by MSL shall not be shared with MR for a sales purpose.

4)

MSL may provide information to and exchange opinions with HCP concerning his/herp. 4

EFPIA Japan MSL Guideline Ver.01 (Translation)company’s own products from the medical, pharmaceutical and other scientific perspectives.
5)

MSL must comply with JPMA’s Code of Practice and other laws and self-regulations
regarding the pharmaceutical companies’ promotion matters even in the cases of Proactive
Information Provision concerning his/her company’s approved products.

In addition, in thecases of the Proactive Information Provision, MSL must use the materials consisting with thepurpose of MSL activities in order to avoid any misunderstanding that MSL engages in any
Sales Activities.

MSL is allowed to use only the materials which have passed his/hercompany’s internal material review process.
6)

MSL may reactively provide the published articles and other scientific literature upon arequest from HCP concerning unapproved drugs and then, based on such articles and literature,
may exchange opinions from the medical, pharmaceutical and other scientific perspectives.
Provided, however, MSJ must comply with the following:A)

In the cases of any information provision or opinion exchange concerning off-label
use, even if it is reactive one, it is advisable that MSL uses the generic name in order
to avoid any misunderstanding that MSL engages in any Sales Activities.

B)

In the cases that MSL engages in any drug development activities, MSL must comply
with GCP and other applicable laws and regulations.

C)

Prior to the approval of drugs, from the medical, pharmaceutical and other scientificperspectives, MSL may exchange opinions with appropriate number of HCP including
the clinical trial investigators, KOLs and other individuals who have knowledge
concerning the proper use of drugs. In this case, the purpose of information collection
must be clearly explained and the details of opinion exchange should be recorded.
Even in this case, in order to avoid any misunderstanding that MSL engages in any
Sales Activities for unapproved drugs, MSL may not conduct any Proactive
Information Provision to HCP.

Especially, during the period from NDA to theapproval when the information and the opportunities of communication with HCP tend
to increase, further careful attention is required.

7.

Advisory Board1)

MSL may plan and operate an Advisory Board from the medical, pharmaceutical and otherscientific perspectives, regardless of whether it is before or after the approval and whether it
relates on-label information or off-label information of his/her company’s own drugs or otherdrugs.

2)

When MSL convenes an Advisory Board, he or she has to clarify its purpose and prepare its
minutes.

3)

Professional advice given by KOL or other stakeholders shall be reflected in the medical plans.

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EFPIA Japan MSL Guideline Ver.01 (Translation)

4)

The MSL activities set forth in this paragraph shall be conducted in a manner to satisfy therequirements set forth in the item 1 through item 5 of the paragraph “6. Provision ofInformation and Exchange of Opinions concerning drugs”.

8.

Seminars and Other Events1)

MSL may at a Medical Seminar held by the Company, plan and operate said seminar on theprevention, diagnosis and treatment of diseases from a medical, pharmaceutical, or otherscientific perspective. In such case, MSL may refer to the drugs for said disease areas,
however, shall give due consideration not to make any explanation solely towards thecompany’s own products.

The same shall apply with regard to seminars co-held withscientific congresses. (This is a rule on planning of events held by Medical.)2)

MSL may make a presentation from the medical, pharmaceutical and other scientificperspectives in the seminars held by the department conducting any Sales Activities of his/hercompany’s own products (including the seminars jointly held with other pharmaceuticalcompany).

Provided, however, he or she must not make any presentation containing any

Sales Activities of his/her company’s products but may provide only the medical,
pharmaceutical or scientific knowledge. The same rule applies to the seminars co-held withscientific congresses. (This is the rules for making a presentation at the seminars held by themarketing/sales departments)
3)

MSL may, at an exhibition booth at a scientific congress, plan and operate said exhibitionbooth on prevention, diagnosis and treatment of diseases from a medical, pharmaceutical, orother scientific perspective.

In such case, MSL may comment on pharmaceuticals for saiddisease areas, but shall give due consideration not to make any biased explanation solely
towards the company’s own products. (This is a rule on planning of events held by Medical.)
4)

The MSL activities set forth in this paragraph shall be conducted in a manner to satisfy therequirements set forth in the paragraph “6. Provision of Information and Exchange ofOpinions concerning his/her Company’s Own Drugs”.

9.

Research concerning Drugs

MSL may support clinical trials, clinical studies and other research activities in compliance with theapplicable laws and regulations, and self-regulation.
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