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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