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/
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
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