Conference Vetting System

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Conference Vetting System Budapest, 15 May 2012 Bernard Maillet Eucomed Compliance Panel

Disclosure Former Secretary-General UEMS Pathologist in a Private Laboratory, by Brussels Member of Eucomed Compliance Panel Board Member of Mdeon Member of the Rome Group Supported by an unrestricted grant by Serono Symposia International Foundation 2

Medical Device Industry Global Context Collaboration and partnerships between hospitals, clinicians, nurses and other HCPs: driver of innovation Education and training: key to ensure safe delivery of services to patients The importance of commercial support to HCPs National and International regulatory frameworks Need for the Industry to adhere to high ethical standards and to comply with all applicable rules, laws and regulations. Medical device sector seeks to support HCPs in a manner which does not jeopardize its own reputation or that of HCPs 3

Eucomed Code of Ethical Business Practice Regulates interactions between Eucomed members and healthcare professionals Support industry self-regulation on interactions with HCP September 2008: Eucomed revised its code of ethics now called the Eucomed Code of Ethical Business Practice (the Eucomed Code ) October 2011: Eucomed produced a Guidance Document (Q&A) which explains the Code in more detail through a series of Questions and Answers Purpose of the Code: Cover all types of interactions, 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 4

The Compliance Panel Independent body created by Eucomed to ensure consistent interpretation of the Eucomed Code of Ethical Business Practices Its role in the Conference Vetting System: Supervise the Compliance Officer Ensure treatment of requests in full compliance with competition policy rules Hear appeals of decisions (procedure to be defined at the end of the pilot phase) 5

The Conference Vetting System (CVS) The Conference Vetting System (CVS) will review compliance of third-party educational conferences with the ethical rules established by the Eucomed Code of Ethical Business Practice. Who can submit : Eucomed Corporate Members, members of National Industry Associations and conference organisers may submit for review conferences taking place in the European Union, Iceland, Liechtenstein, Norway, Switzerland, Russia, Turkey and the Middle East. The assessment criteria: include geographic location, conference venue, accommodation, hospitality, entertainment, the marketing support and invitees. Online submission at least 90 days prior to the event Assessed within 30 days of submission Notification 10 days prior to publication of negative assessment Published in conference database Recommendations only during pilot phase 6

Further details Communication outreach to different stakeholders National Associations: key role as ambassadors for the system Professional conference organisers Information kit (under preparation) Evaluation of the Pilot Phase by the Eucomed Board expected in June Board to decide at the end of the Pilot Phase on the scope of the system Only direct sponsorship of HCPs or any type of sponsorship (e.g., booths, grants, advertising) We invite comments and questions during the pilot phase 7

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