April 2014
EFPIA Japan
Principle Relevant to Contract-Based Funding to Investigator Sponsored Study (ISS)1.

Objective
For the purpose of assuring that a fund supplied by a pharmaceutical company toan Investigator Sponsored Study (ISS) does not become a means to unfairly inducea deal of ethical drugs and is used appropriately for academic research and also forthe purpose of securing the transparency of such fund, this principle is prepared toapprove contract-based funding as one of cooperation forms other than donationand specify the relevant rules that have been unclear.

2.

Definition
ISS is a study sponsored by a physician instead of a pharmaceutical company.
Here, the “Investigator Sponsored Study” refers to a study, regardless of whether aclinical study or a non-clinical study, in which an investigator (including a medical
institution and an incorporated non-profit organization etc. and hereinafter referred
to as “investigator”) takes legal and ethical responsibilities for all of planning, conduct,management, safety and, as necessary, fundraising. The “Guidelines on MedicalResearch” established by Health, Labor and Welfare Ministry will be applied to ISS.
Meanwhile, investigator-sponsored clinical trials for drug application will be excluded
from ISS.

3.

Scope of application of this principle(1) Studies included in the scope of application
ISS to which a pharmaceutical company supplies a contract-based fund insteadof one-sided support by donation
Especially, the funding of an ISS in clinical disciplines conducted by a company
using the company’s own products will be contract-based and this Principle will
be applied.
(2) Studies excluded from the scope of application
Studies not applicable to the definition of ISS including examples belowA) Commissioned studies taken legal and ethical responsibilities by apharmaceutical company
B) Joint studies taken legal and ethical responsibilities jointly by an__________________________________________________________________
c/o Sanofi K.K.
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488
Tel: +81-3-6301-3066 Fax: +81-3-6301-3060

investigator and a pharmaceutical company
C) Investigator-sponsored clinical trials
Even the studies applicable to the definition of ISS will be excluded from thescope of application of this principle when conducted with a donation etc. froma pharmaceutical company.
4.

Requirements(1) On supplying a contract-based fund to ISS, the pharmaceutical company
concerned shall comply with Japanese laws/regulations, industry standards
and the following requirements.
A) The ISS to which a fund is supplied shall be specified, and a written
contract specifying the supply contents shall be concluded with theinvestigator concerned.
B) Purchase or prescription of current or future one’s own products of thepharmaceutical company concerned shall not be a condition for fundsupply.
C) The pharmaceutical company concerned shall not induce planning of ISS.
It is acceptable for the pharmaceutical company concerned to respond to
the investigator’s inquiry about whether a fund can be supplied to ISS or todisclose a study field or type to which a fund can be supplied.
D) The pharmaceutical company concerned shall not be proactively involvedin ISS protocol preparation itself. It is acceptable for the pharmaceuticalcompany concerned to review the protocol or to give a scientific comment tothe investigator concerned.
E) The pharmaceutical company concerned shall not be proactively involvedin ISS planning, conduct or management itself. It is acceptable for thepharmaceutical company concerned to provide the investigator concernedwith information on the safety of one’s own compound or product or torespond to an inquiry from the investigator concerned.
F) The pharmaceutical company concerned shall not make any scientific,
technical or administrative support which may be suspected ofinfringement of the independence of the ISS investigator.
G) The pharmaceutical company concerned shall avoid supplying a fundwhich can be used by the investigator concerned for purposes other than
the study specified by the written contract in the provision A). If the fundsupplied has not been used completely for the target ISS, the remainingfund should be returned from the investigator concerned to thepharmaceutical company concerned.
H) The pharmaceutical company concerned shall arrange the in-houseadvance review system and shall supply a fund only to ISS judged as
scientifically worth conducting.

Also, it shall be confirmed that thebudget of ISS is appropriate and reasonable, and the supply content shall
fit the budget concerned.

In addition, the pharmaceutical company

concerned shall not supply a fund which may be suspected of compensation
for the investigator concerned and expenses which may be deemed to be
private expenses such as wining and dining expenses at a meeting.
I)

In principle, a fund to ISS shall not be paid at once but shall be paid
considering the progress of the study.

J)

Before the results of ISS are published, the pharmaceutical company
concerned should be given an opportunity by the investigator concerned toreview the draft or make a comment.

K) The protocol and outcome document of ISS should appropriately describe
the fact that the ISS concerned is funded by the pharmaceutical company
concerned.

In addition, on using the outcome document of the ISS

concerned for a third party, the pharmaceutical company concerned shalldisclose the fact of fund supply.
L) The right relevant to the ISS outcome shall belong to the investigator
concerned in principle. However, it is acceptable to state in the written
contract in the provision A) that the pharmaceutical company concerned
has the right to use the outcome concerned, or that the right relevant to
the outcome concerned belongs to the pharmaceutical company concerned
when a compound or product of the pharmaceutical company concerned
has been used in the ISS.
End