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Ζητήματα εταιρικής συμμόρφωσης, νέα και ισχύουσα νομοθεσία κατά της διαφθοράς, δικαιώματα ασθενή, ασφάλεια και προστασία προσωπικών δεδομένων - σημαντικά ζητήματα που απασχολούν τις εταιρείες που δρουν στον χώρο της υγείας στην Ελλάδα και αλλού.

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  • 1. Pharma Compliance The way forward Michalopoulou & Associates | 40 Ag. Konstantinou st. | Aithrio Business Center ( 16-18) | 15 124 Marousi Athens Greece T : +30 210 330 52 30 | F : +30 210 330 52 32 | info@lawgroup.gr | www.lawgroup.gr
  • 2. Why Transparency? R&D gives room to Creativity. Transparency is Cheaper! Richard Bergstrom, EFPIA General Director Pharma Law Convention Bucharest 2014 Pharma Compliance: The ONLY Way Forward
  • 3. Pharma Compliance: The ONLY Way Forward Confidential Information & Intellectual Property Rights DATA PROTECTION ANTI-CORRUPTION Patient Safety Competition & Antitrust SALES & MARKETING ETHICS
  • 4. Compliance Jargon ...
  • 5. Anti-Bribery Laws Globally B : FCPA ( ) /OECD ( )
  • 6. FCPA
  • 7. FCPA ( 1977 2002) (Foreign Corrupt Practices Act) / , , . , , .
  • 8. FCPA : SEC , (Securities Exchange Act) 1934 FCPA , , , . : FCPA - FCPA; , , , ! : , FCPA , , , .
  • 9. : FCPA
  • 10.
  • 11. 17 1997. 35 FCPA. . 15 , 1999. . OECD
  • 12. . .
  • 13. 2656/98 (. 3090/2002) 2 , , , , , , , 1 , , , 1 . 3 : . . , , 3 ,
  • 14. 4 (....). 5 , , , , ....: ) 3 ) ) SOS
  • 15. 3691/2008 ( 2005/60/ & ) , 7: 3: ) ( 235) 1 , 50 150.000 . , 10.000 150.000 . ) ( 236) , , , , , , 50 150.000 . , 10.000 150.000 .
  • 16. (. 2005) 6 . 4 , . . 36 . 6 . 4 . ) ) 2 ) 50.000 200.000 .
  • 17. Protection of Personal Data
  • 18. Protection of Personal Data U DATA PROTECTION REFORM Data Protection is made in Europe. Strong Data Protection rules must be Europes Trademark. Viviane Redding, Vice-President & Justice EU Commissioner EU Parliament Strasbourg, March 2014
  • 19. Why Reform? A (easier access to your own data, putting you in control, data protection first not an afterthought) (one continent-one law, one- stop- shop) Protection of Personal Data
  • 20. Current EU & GR Legal Framework: Impossible to contract out . 2472/1997 (EU 95/46/C Data Protection Directive & U e-Privacy Directive 2002/58/EC ) 2 ) : (, , , , , , , , ) . , . ) : , , , , , , , . ) : (, , , , ).
  • 21. Current EU & GR Legal Framework: Impossible to contract out 3 , . 2 ) : , , , , , , , , , , , , (), , .
  • 22. Current EU & GR Legal Framework: Impossible to contract out 4 SOS 3. , : ) ) - , , , , . U Directive 95/46: 19: ) , ) -, .
  • 23. Current EU & GR Legal Framework: Impossible to contract out 2 ) : , , . 7 & 7 SOS 1. . 2. , : ) (, ).
  • 24. Current EU & GR Legal Framework: Impossible to contract out ) ( ) , , & . , , , . ) o . 3. .
  • 25. Current EU & GR Legal Framework: Impossible to contract out 9 1. : ) ) . 10 1. . .
  • 26. Current EU & GR Legal Framework: Impossible to contract out 11 SOS : ) ) ) ) 12 . 13 . (, , ) 15 .
  • 27. European Federation of Pharmaceutical Industries & Associations
  • 28. EFPIA -List of Guiding Principles Promoting Good Governance in the Pharma sector Code on the Promotion of Prescription-only Medicines to & Interactions with Healthcare Professionals (HCP Code) Code of Practice on Relationships between the Pharma Industry & Patient Organizations (PO Code) EFPIA 24/6/2016 - 2015! EFPIA
  • 29. -Compliance A-Z
  • 30. ( 4/4/2014 14/4/2014) () (): No (, TV, , internet)! = . . NEW / , / . Dos & Donts
  • 31. : , e-mails . SOS / . (data on file) . .. , . : . , . ff-label . Dos & Donts
  • 32. : W W : 2 max I : . Dos & Donts
  • 33.