EFPIA Member Association SFEE (The Hellenic Association of Pharmaceutical Companies) last week introduced a new code of industry self-regulation, in line with the EFPIA Disclosure Code

1. PRESS
RELEASE
“Transparency
in
Pharmaceuticals”
–
SFEE
Disclosure
Code
•
A
new
initiative
for
greater
transparency
•
Pharmaceutical
companies
will
disclose
all
types
of
their
interactions
with
Health
Care
Professionals
and
Health
Care
Organizations
Λ. Κηφισίας 280 & Αγρινίου 3, 152 32 ΧΑΛΑΝΔΡΙ, ΑΘΗΝΑ
ΤΗΛ. 210 6891101 – FAX 210 6891060
www.sfee.gr
Athens,
9
October
2014
-­‐
The
Hellenic
Association
of
Pharmaceutical
Companies
(SFEE)
introduced
today
a
new
code
of
industry
self-­‐regulation,
in
an
event
held
in
the
Auditorium
of
the
National
Health
Operations
Centre
(EKEPY).
Through
the
new
Disclosure
Code,
which
was
formally
adopted
by
the
General
Assembly
of
SFEE,
member
pharmaceutical
companies,
based
in
Greece
or
abroad,
commit
themselves
to
disclose
all
the
details
of
their
interactions
with
Healthcare
Professionals
(CRPs)
and
the
Healthcare
Organisations
(HCOs).
Disclosure
will
be
made
through
a
dedicated
electronic
platform,
to
be
provided
soon
by
SFEE,
which
will
be
freely
accessible
by
the
public.
The
measure
will
become
effective
from
1
January
2016
and
will
apply
to
transfers
of
value
made
in
2015.
The
transfers
of
value
to
be
disclosed
may
indicatively
refer
to
grants,
consultancy
fees,
costs
of
participation
in
events,
etc.
The
adoption
of
the
Code
was
a
unanimous
decision
of
the
members
of
the
Association
and
followed
a
number
of
initiatives
at
a
European
level.
In
particular,
the
European
Commission
issued
the
List
of
Guiding
Principles
Promoting
Good
Governance
in
the
Pharmaceutical
Sector
(an
initiative
of
former
Commission
Member
A.
Tajani).
In
line
with
these
principles
and
in
response
to
the
growing
need
for
maximum
transparency,
greater
self-­‐regulation
and
integrity,
EFPIA
(the
European
Federation
of
Pharmaceutical
Industries
and
Associations),
of
which
SFEE
is
a
member
since
1983,
after
a
consultation
with
the
relevant
European
Associations
of
Health
Care
Professionals,
adopted
the
“EFPIA
Disclosure
Code”,
which
all
Member
States,
including
Greece,
are
required
to
transposed
into
their
national
codes.
Beyond
Europe,
a
similar
framework
has
been
introduced
in
the
United
States
with
the
Sunshine
Act.
During
the
Press
Conference
held
by
SFEE
to
introduce
its
Disclosure
Code,
the
Minister
of
Health,
Mr.
Makis
Voridis,
stated:
“The
relations
between
pharmaceutical
companies
and
physicians
have
not
been
transparent
for
a
long
time;
this
left
room
for
criticism
that
cannot
be
evaluated
in
an
organized
manner.
Against
this
background,
I
welcome
SFEE's
initiative.
Indeed,
the
Disclosure
Code
announced
today
ensures
transparency
in
the
interactions
between
health
professionals
and
pharma
companies.
Our
role
as
Government
is
to
legislate
the
mandatory
disclosure
of
information
concerning
the
relations
between
health
professionals
and
the
pharma
industry.
In
this
context,
we
are
promoting
legislative
action
that
will
impose
on
both
parties
the
requirement
to
disclose
such
information.
We
are
giving
it
a
lot
of
thought.
We
understand
individual
interests,
but
the
public
interest
requires
that
patients
have
access
to
this
information
so
they
can
assess
the
objectivity
of
the
medical
advice
they
receive.
With
greater
transparency
in
the
relations
of
physicians
and
companies,
the
credibility
of
both
sides
will
increasingly
be
restored”.

2. Λ. Κηφισίας 280 & Αγρινίου 3, 152 32 ΧΑΛΑΝΔΡΙ, ΑΘΗΝΑ
ΤΗΛ. 210 6891101 – FAX 210 6891060
www.sfee.gr
According
to
SFEE’s
President,
Mr.
Konstantinos
Frouzis:
“Our
country
is
still
in
crisis.
It
is
our
duty
to
help
it
out,
by
continuous
initiatives
for
reform
and
modernisation.
It
is
in
this
context
that
we
have
taken
this
initiative.
This
is
the
only
way
if
we
want
to
contribute
to
the
credibility
and
transparency
that
our
country
badly
needs.
By
this
new
initiative,
we
aim
to
bring
to
the
surface
the
healthy
relationships
between
pharmaceutical
companies
and
healthcare
professionals,
making
them
more
transparent
and
therefore
more
easily
understood
by
patients,
healthcare
stakeholders
and
of
course
the
public
at
large.
As
SFEE’s
President
noted,
“This
new
code
will
make
a
positive
contribution
to
the
overall
effort
that
our
country
is
making
to
get
back
on
a
path
of
growth.
We
pledge
to
step
up
our
efforts
to
support
the
ongoing
education
and
training
of
the
scientific
community
with
a
view
to
improving
the
quality
of
treatment,
research
and
care
in
general.
Today,
the
SFEE
Disclosure
Code
is
ushering
in
a
new
era”.
The
Chairman
of
SFEE’s
Ethics
and
Transparency
Committee,
Mr.
Markos
Gerasopoulos,
said:
“The
success
of
this
initiative
that
is
aimed
at
maximum
transparency
will
crucially
hinge
upon
the
partnership
and
close
collaboration
between
pharmaceutical
companies
and
healthcare
professionals
in
order
to
enhance
transparency
and
public
confidence
of
opinion
in
this
partnership”.
The
Deputy
Director
General
of
EFPIA,
Ms.
Marie-­‐Claire
Pickaert,
stressed
that: “The
pharmaceutical
industry
is
a
valuable
asset
to
Europe
in
many
ways:
but
mistrust
in
the
industry
still
remains
a
hurdle
to
its
realising
its
full
potential
to
drive
health
and
growth
for
Europe.
The
EFPIA
Disclosure
Code
is
one
of
many
initiatives
to
address
this.
EFPIA
believes
that
interactions
between
the
pharmaceutical
industry
and
healthcare
professionals
have
a
profound
and
positive
influence
on
the
quality
of
patient
treatment
and
the
value
of
future
research.
At
the
same
time,
EFPIA
recognises
that
such
interactions
can
create
the
potential
for
conflicts
of
interest.
EFPIA
and
its
member
associations
and
companies
have
adopted
codes
to
ensure
that
these
interactions
meet
the
high
standards
of
integrity
that
patients,
governments
and
other
stakeholders
expect”.
***
For
further
information
you
can
visit
the
relevant
section
on
SFEE’s
website:
http://www.sfee.gr/kodikas-­‐dimosiopiisis-­‐sfee/
and/or
contact
Ms.
Natalia
Toubanaki,
SFEE’s
Communications
Director.
e-­‐mail:
natalia.toubanaki@sfee.gr,
tel.
6947936708,
210
6891101.

3. CODE
AWARENESS
AND
ASSISTANCE
CAMPAIGN
-­‐
DISCLOSURE
CODE
MONTH
SFEE
has
designed
a
series
of
activities
to
raise
awareness
of
the
Code
among
all
stakeholders
and
engage
them
through
their
respective
institutional
roles
to
assist
in
ensuring
compliance
with
the
Disclosure
Code
and
achievement
of
goals.
Today's
event
introducing
the
Disclosure
Code
to
government
officials
and
institutional
representatives,
who
welcomed
and
supported
SFEE’s
initiative,
forms
part
of
these
activities.
The
event
was
attended
by:
Mr.
D.
Lintzeris,
President
of
the
National
Organisation
of
Medicines
(EOF),
Mr.
S.
Evangelatos,
Inspector
General
of
Health,
Mr.
P.
Efstathiou,
Head
of
EKEPY;
Ms.
K.
Angelopoulou,
Head
of
Special
Account
for
R&D
Funds
of
the
1st
Healthcare
Region
of
Attica;
Ms.
A.
Katsifi,
Head
of
the
Information
and
Public
Relations
Directorate,
EOF;
Mr.
M.
Vlastarakos,
President
of
the
Panhellenic
Medical
Association;
Mr.
K.
Lourantos,
President
of
the
Panhellenic
Pharmaceutical
Association;
Mr
G.
Patoulis,
President
of
the
Athens
Medical
Association
and
Mayor
of
Maroussi;
A.
Exadaktylos,
President
of
the
Medical
Association
of
Thessaloniki;
Prof.
Dr
M.-­‐A.
Dimopoulos,
President
of
the
Medical
School
of
the
National
and
Kapodistrian
University
of
Athens;
Mr.
K.
Bakouros,
President
of
Transparency
International
Greece;
Prof.
Dr
N.
Choulis,
Chairman
of
the
Committee
for
the
Reimbursement
List;
Mr.
I.
Giarmenitis,
President
of
the
Hellenic
Cosmetic,
Toiletry
and
Perfumery
Association
(PSVAK);
Mr.
A.
Galanopoulos,
President
of
the
Pharmacist
supplying
cooperative
of
Attica
(PROSYFAPE);
Mr.
P.
Arnaoutis,
President
of
the
Association
of
Health
–
Research
and
Biotechnology
Industry
(SEIB);
Mr.
V.
Seretis,
Vice
President
of
the
Greek
Association
of
the
Self-­‐Medication
Industry;
Prof.
A.
Sissouras
as
well
as
Presidents
of
medical
societies,
Presidents
of
Patient
Associations,
representatives
of
professional
conference
organisers,
etc.
Moreover,
a
Code
Awareness
Campaign
for
healthcare
professionals
nationwide
will
be
running
from
15
October
to
15
November
2014,
during
which
scientific
experts
from
SFEE
member
companies
will
be
visiting
physicians
across
the
country
to
communicate
the
principles
of
the
Disclosure
Code.
In
this
context,
SFEEs
is
also
developing
a
section
dedicated
to
the
Code
of
Disclosure
on
its
website,
where
all
relevant
information
will
be
available.
By
the
beginning
of
2016,
when
the
measure
will
come
into
effect,
SFEE
will
have
completed
the
development
of
a
special
platform
for
companies’
disclosures.
Λ. Κηφισίας 280 & Αγρινίου 3, 152 32 ΧΑΛΑΝΔΡΙ, ΑΘΗΝΑ
ΤΗΛ. 210 6891101 – FAX 210 6891060
www.sfee.gr

4. THE
PROVISIONS
OF
THE
DISCLOSURE
CODE
–
A
CLOSER
LOOK
The
main
provisions
of
the
Disclosure
Code
are
the
following:
• SFEE
member
companies
will
collect
detailed
data
on
all
transfers
of
value
to
HCPs
and
HCOs;
such
data
will
be
posted
on
SFEE’s
website,
itemised
by
recipient.
• An
essential
prerequisite
before
any
type
of
transfer
of
value
and
before
its
Λ. Κηφισίας 280 & Αγρινίου 3, 152 32 ΧΑΛΑΝΔΡΙ, ΑΘΗΝΑ
ΤΗΛ. 210 6891101 – FAX 210 6891060
www.sfee.gr
disclosure
is
the
written
consent
of
the
HCP/HCO
recipient.
• If
the
recipient
refuses
to
give
or
revokes
his/her
consent
once
granted,
the
relevant
data
will
be
published
on
an
aggregated
basis.
• Member
companies
will
also
disclose
on
an
aggregated
basis
the
amount
of
their
R&D
investment.
• Recipients
will
be
identified
by
full
name
and
tax
registration
number.
Disclosures
will
be
made
in
the
Greek
language.
The
data
to
be
disclosed
include:
For
individual
HCP
recipients:
− Registration
fees
and
travel
and
accommodation
in
relation
to
events
(e.g.
scientific
events/conferences/symposiums/boards)
− Fees
for
service
and
consultancy
(e.g.
education/training,
counseling,
speeches/lectures,
general
consultancy
services)
For
individual
HCO
recipients:
− Donations
and
grants
(cash
or
benefits
in
kind)
− Sponsorships
to
HCOs,
directly
or
through
a
PCO,
for
events/conferences/symposia/boards
(cost
of
group
registration
of
HCPs
and
cost
of
sponsorship
under
the
relevant
contract)
− Transfers
of
value
resulting
from
or
related
to
contracts
between
pharmaceutical
companies
and
HCOs
for
any
other
type
of
service
and
consultancy
Aggregated
disclosure
applies
to
transfers
of
value
related
to
the
planning
and
conduct
of:
− Non-­‐clinical
studies,
clinical
trials
(Phase
I,
II,
III,
IV),
non-­‐interventional
studies
are
prospective
in
nature
and
related
to
the
collection
of
patient
data
by
or
on
behalf
of
a
group
or
a
HCPs
specifically
for
the
study;
− Events
related
to
R&D
(e.g.
investigator
meetings,
advisory
boards
for
clinical
research,
steering
committee
meetings,
consultancy
meetings
for
clinical
research,
technical
training
for
clinical
research).
EXEMPTED
from
disclosure
are
the
following:
-­‐
Transfers
of
value
exclusive
relating
to
OTC
medicines
-­‐
Working
meals
in
the
context
of
events
or
otherwise
-­‐
Samples
of
medicinal
products
-­‐
Medical
practice
items
of
negligible
value
(<€15)
-­‐
Ordinary
business
transactions
(pharmaceutical
distribution
chain)
***