Les intérêts du Professeur Lechat avec Merck…….

Dés demain le document authentique sera sur le site

PUBLIC DECLARATION OF INTERESTS AND CONFIDENTIALITY UNDERTAKING OF EMEA
SCIENTIFIC COMMITTEES MEMBERS AND EXPERTS
This document consists of two parts, the Public Declaration of Interests and the Confidentiality Undertaking. Both parts
should be duly completed. All pages have to be signed and dated. If the document is completed by hand, please
ensure that the information required is presented clearly.
PUBLIC DECLARATION OF INTERESTS
I, Prof. Philippe Lechat
Nationality France
Organisation/Company AFSSAPS
Professional address 143,147 Boulevard Anatole France 93285 SAINT DENIS
Email address philippe.lechat@afssaps.sante.fr
do hereby declare on my honour that, to the best of my knowledge, the only direct or indirect interests I have
in the pharmaceutical industry are those listed below:
(Please tick all boxes, and specify company and product name in case of a declared interest1
. If necessary, use
additional dated and signed sheets).
Table 1
Activity for a company in relation to a particular product /
group of products No
Currently or
in the
previous
year
More than 1
year but
less than 5
years ago
More than 5
years ago 2
Employee
Consultant3
Principal investigator4
Member of a steering committee, member of an
advisory board, or equivalent body
Investigator (not principal) for the development of a
product5
SIGNATURE: (on file)
DATE: 08/10/2008

1
If you tick any of the shaded boxes (declared interest), you must provide additional information regarding company and products
involved on Page 2. If you declare an interest in Table 1 but do not provide the relevant information on Page 2, your form will be
returned to you for completion. 2 You are invited to provide information on interests over 5 years ago. This information will not be used in the evaluation of declared interests
but will be useful in the context of an increased transparency as regards previous interests. 3 A consultant is defined as an expert who charges a fee (personal, institutional or both) for providing advice or services in a particular field 4 A Principal Investigator, for the purposes of this document, is considered to be the (co-ordinating) investigator responsible for the coordination
of investigators at different sites participating in a multicentre trial. 5
An Investigator, for the purposes of this document, is considered to be an investigator involved in a clinical trial at a specific trial site. An
investigator may be either the responsible leader of the clinical trial team (responsible for the conduct of the clinical trial at that site, including
designation and supervision of the team) or a member of the team, who performs critical trial related procedures and makes important trial
related decision

Period of activity Company Products
Please list any
products for which
you had primary
responsibility
Therapeutic
indication
Employee
Period of activity Company Products
Please list any
products for which
you acted as a
consultant with
respect to their
development.
Therapeutic
indication
Consultant
Period of activity Company Area of activity /
product
Therapeutic
indication
Member of
a steering
committee,
member of
an
advisory
board, or
equivalent
body
2000-2004 MERCK KGa Bisoprolol
CIBIS III trial
heart failure
Period of activity Company Products Therapeutic
indication
Principal
investigator
2000-2004 MERCK KGa Bisoprolol
CIBIS III trial
heart failure
Period of activity Company Products Therapeutic
indication
Invest

I have a financial interest in a pharmaceutical
company of: NO YES Company
• more than 50,000 Euro or equivalent
(Investment funds excluded)

• less than 50,000 Euro or equivalent
(Investment funds excluded)

NO YES Company and Product
Name
I own a patent on a product
The organisation I am employed by receives a grant
or other funding from a pharmaceutical company (I
receive no personal gain)1

Further to the interests declared above, I do hereby declare on my honour that I do not have any other
interests or facts that should be made known to the Agency and the public. In case of any other interests or
facts, please specify:

Should there be any change to the above due to the fact that I acquire additional interests, I shall promptly
notify the EMEA and complete a new Declaration of Interests detailing the changes. This declaration does not
discharge me from my obligation to declare any potential conflicting interest(s) at the start of any EMEA
Activity2
in which I participate.
CONFIDENTIALITY UNDERTAKING
In view of the following definitions:
“EMEA Activities” encompass any meeting (including meeting preparation and follow-up, associated discussion or
any other related activity) of the EMEA’s Committees, its Working Parties, Expert Groups, or any other such meeting,
work as an expert on assessments, and work as an expert on guidance development.
“Confidential Information” means all information, facts, data and any other matters of which I acquire knowledge,
either directly or indirectly, as a result of my EMEA Activities.
“Confidential Documents” mean all drafts, preparatory information, documents and any other material, together with
any information contained therein, to which I have access, either directly or indirectly, as a result of my participation in
EMEA Activities. Furthermore, any records or notes made by me relating to Confidential Information or Confidential
Documents shall be treated as Confidential Documents.
I understand that I may be invited to participate either directly or indirectly in certain EMEA activities and
hereby undertake:
– to treat all Confidential Information and Confidential Documents under conditions of strict
confidentiality.
– not to disclose (or authorise any other person to disclose) in any way to any third party3
any
Confidential Information or Confidential Document.
– not to use (or authorise any other person to use) any Confidential Information or Confidential
Document other than for the purposes of my work in connection with EMEA activities.
– to dispose of Confidential Documents as confidential material as soon as I have no further use for
them.
This undertaking shall not be limited in time, but shall not apply to any document or information that I can
reasonably prove was known to me before the date of this undertaking or which becomes public knowledge
otherwise than as a result of a breach of any of the above undertakings.
SIGNATURE: (on file)

DATE: 08/10/2008

1
Excluding any fees paid by pharmaceutical industry for assessment work undertaken by National Competent Authorities.
2
EMEA Activity encompasses any meeting (including meeting preparation and follow-up, associated discussion or any other related
activity) of the EMEA Committees, its Working Parties, Expert Groups, or any other such meeting, work as an expert on
assessments, and work as an expert on guidance development. Following the assessment of the declared interests, the EMEA may
limit the input to EMEA activities. 3
Third party does not include employees of the National Competent Authorities who either have employment contracts that provide
confidentiality obligations or are e