51st ICCA Congress
International Congress and Convention Association.
Twitter: #ICCA12
Session sponsored by:
International Healthcare Congresses (WE103)
51st ICCA CONGRESS - San Juan, Puerto RicoWednesday October 24, 2012
John McLoughlinChairman – Eucomed Compliance Panel
Healthcare Conferences
Ethics and Compliance
What is Eucomed?
European Medical Technology Industry Association
(EUCOMED) is composed of:
62 Direct Corporate Members
26 National Associations
5 Associated National Associations
22,500 businesses which are “indirect” members
via their national associations
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EUCOMED’S GOALS
Primary goals:
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Engage with European regulators, politicians and other policy makers to develop and propose patient-centered policies that enable people to live healthy and productive lives and provide solutions that significantly drive the productivity and efficiency of healthcare systems.
Demonstrate the value of medical technology
Provide membership services
Promote Ethical Business Practices
Eucomed Code of Ethical Business Practice
In September 2008 Eucomed revised its code of ethics which is now called
the Eucomed Code of Ethical Business Practice (the “Eucomed Code”)
As part of the Eucomed Code, a Guidance Document (Q&A) has been
issued which is updated periodically and which explains the Eucomed Code
in more detail through a series of Questions and Answers
Ethics & Compliance Resources: http://www.eucomed.org/key-themes/ethics
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Scope of the Eucomed Code
The Eucomed Code covers all types of interactions with
healthcare professionals (HCPs), including research and
consulting agreements, gifts as well as the sponsorship
of healthcare professionals to attend company events
and third party professional and educational conferences.
It applies to direct and indirect Eucomed members.
National Associations must incorporate the provisions of
the Eucomed Code into their own codes.
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The Eucomed Compliance Panel
Independent body created by Eucomed to ensure
consistent interpretation of the Eucomed Code of Ethical
Business Practices
Complaint resolution and enforcement function
Supervises the EthicalMedtech Conference Vetting
System created by Eucomed and managed by a
Compliance Officer
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Need for a single conference vetting system
The problem was that every Eucomed member company had
to make its own decision as to whether or not a conference
was compliant with the Eucomed Code
To solve this problem, the Eucomed Board created a
centralised decision-making system under the supervision of
the Compliance Panel to assess third party educational
conferences
The Board also decided not to follow the EFPIA route - The
Eucomed EthicalMedtech Conference Vetting decisions are
binding on Eucomed members
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The Conference Vetting System (CVS)
The system operates independently of Eucomed to ensure objectivity
in conference assessments
Separate website & visual identity: www.ethicalmedtech.eu
Pilot phase began on March 21, 2012
The full operational phase started on October 1, 2012
Assessment decisions are made by the EthicalMedTech Compliance
Officer
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Who can submit conferences for assessment?
Eucomed members:
Direct corporate members
National associations
Associated national associations
Conference organizers
Including medical and scientific societies
Members of the national associations (indirect members)
Have to file a submission through their national association
Extension of the CVS will take place over time
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What conferences are subject to assessment?
Currently only European conferences
Participants from more than one European country
Europe:
EEA countries
Switzerland
Associate members’ countries
N.B: The Compliance Panel may, exceptionally and at its discretion, extend the scope
to national and/or international conferences.
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EU 27 + Iceland, Liechtenstein & Norway
Russia, Turkey and the Middle East
The Assessment Criteria
Geographic Location & Conference
venues
Scientific Program
Hospitality, Social Events and
Entertainment
Accommodations
Spouses, partners, family and guests
Brochures and Communications
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PRE-CLEARANCE OF LOCATION & VENUE
The Eucomed EthicalMedTech Conference Vetting System will be
extended shortly to allow conference organizers to obtain “pre-
clearance” of conference geographic locations and facility venues.
The Pre-Clearance submission may be made years in advance of a
conference in order for conference organizers to make sure that
before contractually committing themselves (and the organizations
that they represent), the geographic location and facility venues are
compliant with the Eucomed Code.
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What Companies Must Do
Inform the superiors or organizations who employ the sponsored
healthcare professionals about the financial support provided to
attend a conference
Comply with other provisions of the Eucomed Code not covered by
the Conference Vetting System
Avoid any conduct which gives the appearance of being
inappropriate
Comply with local laws, regulations and codes of conduct
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COMPLAINTS AND SANCTIONS
Complaints regarding alleged violations of the Eucomed Code are handled in
the first instance by National Association Compliance Panels.
National Association Compliance Panels and parties to a complaint procedure
may refer questions of interpretation of the Eucomed Code to the Eucomed
Compliance Panel during the complaint procedure or after the National Panel
has issued a ruling.
Sanctions may include: inspection and audit of the offending company, the
recovery of items given in connection with the promotion of products,
publication of corrective information, withdrawal of accreditation by the
National Association or Eucomed.
Publication of Panel decisions.
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