This document discusses global transparency requirements for medical meetings and payments to healthcare professionals. It covers details of disclosure obligations under the French Sunshine Act, which requires disclosure of hospitality costs, research contracts, consultancy agreements, and any benefits provided to covered recipients. It also briefly mentions transparency requirements and identifiers used in Australia. The remainder of the document outlines an agenda for a conference on global transparency reporting, including examining regulations, implementing global reporting systems, managing regional requirements, and working with third parties to comply with transparency initiatives.

1. Global Transparency Requirements
& Medical Meetings
Agnès Canonica, CMP, CMM

2. French Sunshine Act
Declaration Scheme Willing to Be “Broader and More Transparent" than
US Sunshine Act
• The disclosure obligation, as stated in the Law, includes any
agreements or advantages in kind or in cash, direct or
indirect. Therefore, companies would have to disclose the following:
• “Hospitality conventions”, i.e., invitations of individual HCPs to
scientific or medical events for which companies pay the related costs
(such as registration fees, travel costs, meals and accommodation
expenses)
• Agreements of any nature, including research and development
contracts (clinical trials, observational studies), other consultancy
agreements (speaker, advisory boards), and aids or grants in any form
• Any benefit in cash or in kind, including any gift offered to a covered
recipient and any lunch offered to HCPs by a medical sales
representative after a medical visit

3. French Sunshine Act
Still in process of government approval
http://www.jdsupra.com/legalnews/french-
sunshine-act-implementing-decree-39226/

4. Australia
• Equivalent of NPI # = IHI
• 16 digits
• Individual Healthcare Identifier

5. Country Approvals
• CNOM – France
• MDEON – Belgium
• Italy
• Spain
• Marketing/meeting materials

6. Discussion
• Working through CROs
• Establishing Fair Market Value – globally
• Vendors – how can they help?
• Policies / vendor training
• How are agencies managing the influx of data
management
• PM training

7. Registration
• Disclaimers
• Required fields
• Unique identifiers

8. TOV Reporting
• Domestic vs. International
• Fields
• Licensed vs. non-licensed
• Reporting deadlines
• Individual vs. aggregate/average costs
• Tracking breaks
• DDR in EU
• Pre/post expenses

10. RFID

11. Barcode Scanners

12. Sign-In Sheets

13. Global Clinical Payment Technology
ClinCard
eClinicalGPS
www.greenphire.com

14. Resource
CBI 3rd Global Transparency Reporting Congress
April 10-11, 2013 * Brussels, Belgium
Through this interactive forum, you will:
• Examine current international transparency regulations including an
update on the EFPIA code
• Learn solutions for implementing a global system
• Improve business processes through communication of value
• Hear valuable case studies on managing regional requirements
• Discuss privacy and data protection implications of reporting
• Work effectively with CROs, CSOs, meeting planning agencies and
other third parties
• Understand the impact of transparency initiatives on the relationships
between industry and HCPs

15. Guiding Principal…
“It is not the strongest of the species that
survives, nor the most intelligent that survives. It is
the one that is the most adaptable to change.”
- Charles Darwin

16. PRESENTER’S CONTACT INFO