1. First International Medical Device Compliance Congress
Industry Codes of Ethics: Analysis of Enforcement Mechanisms – taking Self Policing to a Whole New level
First International Medical Device Compliance Congress
Paris, May 27, 2008
Session 2.01
(12:45 – 13:45)
Dirk Brinckman
Senior Counsel Europe
Johnson & Johnson

2. Complaint Handling Mechanism
DISPUTE RESOLUTION
Complaint Handling Mechanism
Eucomed
National Associations

3. EUCOMED – Dispute Resolution
BASIC PRINCIPLES
Complaints re Eucomed Code
Realistic timelines
Fair procedure / independence
Cost-effective

4. EUCOMED – Dispute Resolution
Decision tree
Review by independent panel
Predictable sanctions
Publicity

5. National Dispute Resolution

6. Enforcement of the Code of Business Practice
Country
1a) When?
1b)
Pre-existing
code?
1c) Changes to EU?
2) Legal hurdles?
3+4) Lobby?
5) Enforcement?
8) Experiences
9) New costs?
Austria
Planned
introduction:
Spring 2007 No
Yes
N/A
Costs of
arbitration
are to be
paid by
defeated
party;
findings
have
decide
about
bearing
costs.
Appealing
party
has
advance €
2.000 (á conto).
Belgium
Eucomed Code
Law 2004
Czech Republic
June 2005
The
estimate
enforcement costs
would in
range
CZK
100,000,-
(EURO 3,500,-)
Denmark
Turn
the
year 2003/2004
Finland
9/21/2005
but
only
professional
societies
France
June 2003
Different
from
Eucomed code
National
and
european
laws
trading
practice
French
Public
Health Code.
Only industry
Any
legal
expenses
payable
reprimanded.
Germany
1996
Greece
6/15/2006
The code includes
the main topics of
Eucomed code, plus
the national legal
requirements
Hungary
Ireland
Italy
2005
Yes, from 1993
Netherlands
covered by guilty
Norway
2001,
updated
in 2006
Mainly
based on
Yes,
primarily
hearing
aids
colostomy
companies
allocated
general budget
Poland
Translation
Limited
Not yet
Not decided yet
Portugal
Slovakia
October 6,
2006.
Few
Still limited
Compulsory bond
deposit of SKK
10,000 (ten
thousand Slovak
Spain
Jan.2005
Covered by fines
Sweden
July 2006
Yes (time) no fee
Switzerland
2003
Covered by M-fee
Romania
Oct. 2004
Yes, complaints UK
Some
Estimation
Enforcement of the Code of Business Practice

7. Questions on procedure rules
Investigation
body
Composition of
the body
Findings
Due timing
Confidentiality
Sanctions
Q.10
Participation in
your
complaint process
Austria
Arbitration panel 3
arbitrators: 1
nomitated by
AUSTROMED`s
Board,
General
Assembly,
chaired a
lawyer
(not
member/
independant),
nominated
Board
( 3 years term).
are
delivered
formally
and
reported to
all
ass. members.
Arbitrators
shall
convene
within 16
days
after
first
complaint
about
alleged
infringement.
Yes
Admonition,
expulsion,
publication
findings
AUTROMED´s
media
for
members
compulsory.
Belgium No
Unamec secretary in collaboration with company representatives not linked with the dossier.
Reported
only
internally
with
the
parties concerned
N/A
Code, art. 11 article.
Czech Republic
Ethical
Committee
CzechMed
Association
6 members
four
weeks
from
delivery
financial
penalty
exclusion
Voluntary
Denmark
Not relevant
Finland
France
Professional Code
Ethics
&
Good
Practices
Commission
3 board members
and a former board
member or key
figure who has
had important
functions within our
Industry.
Annual report
A warning,
Publication of
information in
SNITEM’s internal
communication
media, the content
of which is decided
on by the Ethics
Commission or
Expulsion from the
Association.
Germany
Greece
The Executive
Committee of
Hellasmes is
responsible to
investigate every
complaint.
Appeal: General
Assembly of the
Various
ethical
penalties, up
exclude
member
Hungary
Ireland
Italy
Comitato di
Controllo + Giurì
Member and lawyers
Compulsory
Netherlands
Supervisory
committee +
monitoring group
independent
persons
outside
Nefemed.
The
chairman is
lawyer.
Complaints
must be
substantiated
can
dealt
orally
writing. In
case
oral
procedure
hearing
public
unless
confidentiality
is involved.
Yes,
articles
13-14
Yes, article 27
decision
committee takes the
form an
advise
Nefemed
board.
sanction
varies
reprimand
membership.
fee
starting
legal
entities
1.000
euro’s
individuals 50 euro’s.
Questions on procedure rules