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The  Future  of  Transparency:  
5  Pillars  for  Global  Success
October  15,  2015
Pete  Sandford
Executive  Vice  
President  and  
Co-­founder
NXLevel  Solutions
Welcome
Through  its  PharmaCertify™ division,  NXLevel  
Solutions  delivers   innovative  and  practical  
learning  and  information  solutions  to  
compliance   organizations  in  the  
pharmaceutical   and  medical  device  industries.
Berkeley   Research  Group,  LLC  is  a  leading  global  
strategic  advisory  and  expert  consulting  firm  that  
provides  strategic  advice,   independent  expert  testimony,  
litigation  and  regulatory  consulting,  authoritative  studies,  
and  document  and  data  analytics   to  major  law  firms,  
Fortune  500  corporations,  government  agencies,   and  
regulatory  bodies  around  the  world.  
Katherine  Norris
Director,  Corporate  
Compliance  and  Risk  
Management
Berkeley  Research  Group
• A  Brief  History  of  Transparency  
Reporting
• Transparency  Reporting  today
• Five  Pillars  to  Steer  You  Into  the  
Future
• Q  &  A
Our  Agenda:
The  Future  of  Transparency:  Five  Pillars  for  Global  Success
Major  Milestones  in  Transparency  Reporting
2016	
  &	
  
Beyond20152014201320122011
2010	
  &	
  
Earlier
EFPIA	
  Disclosures	
  
Published	
  (2016)
EFPIA	
  Data	
  Collection	
  
Begins	
  (Jan.	
  2015)
Australia	
  Medicines	
  
Code	
  Revised	
  for	
  
Enhanced	
  Disclosures	
  
June	
  2015)
EFPIA	
  Code	
  
Implemented	
  (6/13)
Loi	
  Bertrand	
  First	
  
Disclosures	
  Due	
  
(Aug.	
  2013)
Loi	
  Bertrand	
  
amended	
  to	
  
require	
  assigned	
  
value	
  to	
  HCP	
  
contracts	
  
(Feb.	
  2015)
Loi	
  Bertrand	
  
Reporting	
  Begins	
  and	
  
is	
  Retroactive	
  to	
  
2012	
  (May	
  2013)	
  
US	
  OIG	
  Compliance	
  Guidance	
  Released	
  
(5/03)	
  
JPMA	
  Code	
  (4/08)	
  
US	
  Open	
  Payments	
  adopted	
  as	
  part	
  of	
  the	
  
PPACA	
  (2010)	
  
US	
  companies	
  with	
  CIAs	
  are	
  required	
  to	
  
disclose	
  certain	
  transparency	
  information	
  
related	
  to	
  grants	
  and	
  charitable	
  
contributions
Open	
  Payments	
  
Reporting	
  Begins	
  
In	
  2	
  Phases	
  
(Feb.-­‐June	
  2014) Australia	
  
Medicines	
  Code	
  
Adopted	
  
(June	
  2014)
Australia	
  Medicines	
  
Code	
  Revised	
  to	
  
Include	
  
Transparency	
  
Reporting	
  
Requirements	
  
(June	
  2012)
State	
  Reporting	
  Requirements	
  
(CA	
  – 1995,	
  MA	
  – 2009,	
  MN	
  – 1993)	
  
PhRMA Code	
  Implemented	
  (2002)
Preliminary	
  drafts	
  of	
  Physician	
  Payments	
  
Sunshine	
  Act	
  
(2007,	
  2008,	
  2009)	
  
Open	
  Payments	
  
Disclosures	
  
Published	
  
(Sep.	
  2014)
Number  of  
countries  
currently  
publishing  
data
4
Where  are  we  now?
Number  of  
countries  
publishing  
data  
in  2016
36
Where  are  we  now?
Number  of  
countries  with  
statutory  
transparency  
codes
6
Where  are  we  now?
Number  of  
countries  with  
voluntary    
transparency  
codes
37
Where  are  we  now?
The  numbers  
are  huge
HCP  &  HCO
Concerns
• Negative	
  impact	
  on	
  ability	
  to	
  attain	
  or	
  keep	
  
research	
  grants	
  
• Reduced	
  opportunities	
  for	
  research	
  and	
  
consulting
• Worry	
  about	
  adhering	
  to	
  conflict	
  of	
  interest	
  
policies
• Changing	
  COI	
  policies	
  
• Misinformation
• Education	
  and	
  Awareness
• Time	
  consuming	
  registration,	
  review	
  and	
  
dispute	
  processes
• Dissention	
  with	
  hospitals
The  Current  Environment
Manufacturer  
Challenges
• Time	
  and	
  effort	
  to	
  resolve	
  disputes
• Communication	
  and	
  training	
  not	
  “sticking”
• Managing	
  recording	
  and	
  reporting	
  from	
  
various	
  business	
  units
• Collection	
  from	
  third	
  parties	
  can	
  be	
  
unreliable,	
  resulting	
  in	
  data	
  inconsistencies
• Poor	
  understanding	
  of	
  actual	
  requirements	
  
of	
  law;	
  incorrect	
  assumptions	
  =	
  bad	
  data
• Perception	
  that	
  transparency	
  requirements	
  
are	
  bureaucratic	
  and	
  not	
  beneficial
The  Current  Environment
The  Future  of  Transparency
Polling  Question:  
What  is  your  company’s  biggest  
concern  about  global  
transparency  reporting?
Five  Pillars  for  Global  Success
Best  Practices  for  
Global  Awareness
Getting  to  Know  Your  Global  Business  
Think  globally,  
act  locally...
• Where	
  do	
  you	
  operate?
• What	
  are	
  the	
  corporate	
  structures	
  
in	
  those	
  countries?
• What	
  legal	
  and	
  voluntary	
  code	
  
disclosure	
  requirements	
  exist?
• Are	
  your	
  current	
  businesses:	
  
• Subject	
  to	
  applicable	
  requirements?
• Aware	
  of	
  requirements?
• Resourced?
• Operating	
  independently?	
  
• Using	
  corporate-­‐wide	
  infrastructure?
• Who	
  are	
  your	
  points	
  of	
  contact?
Getting  to  Know  Your  Global  Business  
Putting  Pen  to  Paper:  
What  Do  You  
Need  to  Know?
Best  Practices  for  Global  Awareness
Form  a  global  
transparency  
steering  
committee
Best  Practices  for  Global  Awareness
Establish  and  
maintain  a
process  &  cadence  
for  global  
environment  
scans
Country
Law	
  or	
  
Industry	
  
Code
Individual	
  or	
  
Aggregate	
  
Reporting
Applicability	
  –HCPs,	
  HCOs Reported	
  Items TOV	
  Thresholds Notes
United	
  
Kingdom
Industry	
  
Code
Individual	
  -­‐
encourages	
  
contractual	
  
agreement	
  for	
  
individual	
  disclosure
HCPs	
  -­‐ physician,	
  nurses,	
  dentist,	
  
pharmacist
HCO	
  -­‐medical	
  societies	
  
Travel,	
  Education,	
  
R&D,	
  Meals,	
  Gifts,	
  
Hospitality
None	
  at	
  this	
  time NHS Contemplating	
  
HCP	
  driven	
  disclosures	
  
France
Law Individual HCP	
  -­‐ physician,	
  nurse,	
  
pharmacist,	
  medical	
  students,	
  
software	
  developers	
  and	
  more
Benefits	
  (meals,	
  gifts,	
  
travel,	
  etc.)	
  and	
  
Contracts	
  with	
  HCPs
Benefits	
  -­‐ equal	
  to	
  or	
  
greater	
  than	
  €10
Contracts-­‐Notification	
  
of	
  contract	
  and	
  its	
  
value
Portugal
Law Individual HCPs,	
  HCO,	
  Patient	
  Organisations Sponsorship,	
  funding €65
Netherlands
Industry	
  
Code
Aggregate HCPs,	
  institutions,	
  partnerships Meals,	
  contracts,	
  
travel	
  etc.	
  R&D	
  
excluded
TOVs	
  over	
  €500/	
  year TOV	
  data	
  published	
  in	
  
a	
  central	
  database.
Data	
  must	
  be	
  
submitted	
  in	
  first	
  3	
  
months	
  of	
  the	
  year
Estonia
Law Individual HCPs All	
  non-­‐clinical	
  HCP	
  
engagements
In	
  excess	
  of	
  €6.48
Denmark	
  
Law Individual HCPs Name,	
  address,	
  and	
  
civil	
  registration	
  
number	
  of	
  any	
  
physician	
  or	
  dentist	
  
associated	
  with	
  the	
  
company.	
  
Additional	
  detail	
  about	
  
financial	
  relationships	
  
may	
  be	
  requested	
  by	
  
the	
  Danish	
  Medicines	
  
Authority.
Law Individual HCPs TOVs	
  for	
  marketing	
  
and	
  non-­‐monetary	
  
Best  Practices  for  Global  Awareness
Proactively  
adapt  
to  global  
developments
Managing  Global  Transparency:  A  Continuum
GlobalRegionalLocal
Variables
People Processes Policies Controls
Tracking	
  &	
  
Reporting
Systems	
  
&Tools
Five  Pillars  for  Global  Success
Why  manage
Pre-­disclosure?
51	
  percent	
  
of	
  surveyed	
  physicians	
  who	
  visited	
  the	
  
CMS	
  Open	
  Payments	
  site	
  
found inaccuracies	
  in	
  
the	
  data
Why  Manage  Pre-­disclosure?
Data
Accuracy
-­‐ 2014	
  MedPanel Survey	
  of	
  461	
  Physicians
Dispute  
Channel
85	
  percent	
  
of	
  physicians	
  would	
  like	
  a	
  
channel	
  to	
  dispute	
  
payments	
  prior	
  to	
  
reporting	
  and	
  public	
  disclosure.
Why  Manage  Pre-­disclosure?
-­‐ 2012	
  Regulatory	
  Law	
  Group	
  Survey	
  of	
  50,000	
  Physicians
Online
Portal  
Access
61	
  percent	
  
of	
  physicians	
  would	
  access	
  
an	
  online	
  portal	
  to	
  
proactively	
  review	
  and	
  manage	
  
financial	
  data	
  to	
  be	
  reported.
Why  Manage  Pre-­disclosure?
-­‐ 2012	
  Regulatory	
  Law	
  Group	
  Survey	
  of	
  50,000	
  Physicians
Does  your  
company  have  a  
formal  TOV  
pre-­disclosure  
process  in  place?
Your  Perspective…
Polling  
Question
Why  Manage  Pre-­disclosure?
•To	
  ensure	
  data	
  accuracy	
  
•To	
  resolve	
  disputes	
  before	
  
data	
  goes	
  public
•To	
  build	
  partnership
•To	
  increase	
  consent	
  of	
  HCP’s	
  
where	
  required
Best  Practices  for  
Managing  
Pre-­disclosure
Best  Practices  for  Managing  Pre-­Disclosure
Develop  and  
implement  
SOP’s  in  
partnership  with  
business  
stakeholders
Best  Practices  for  Managing  Pre-­Disclosure
Establish  a  
communication  
“triangle” with  key  
customers
Best  Practices  for  Managing  Pre-­Disclosure
Provide  a  
streamlined  
platform  
for  HCP’s  
and  HCO’s  
to  view  and  
inquire  
Click	
  on	
  a	
  payment	
  below	
  to	
  view	
  details	
  and	
  inquire.
HCP	
  Statement
Five  Pillars  for  Global  Success
Best  Practices  for  
scaling  and  aligning  
business  processes
Build  and  
follow  a  
roadmap
Scaling  and  Aligning  Business  Practices  
Great Falls	
  Pharma	
  – Global	
  Transparency	
  Assessment	
  
Country Voluntary Code  
Statutory  
Requirement  
Prior  Consent
Individual
Reporting  
Company	
  
Website	
  
Central	
  
Repository
Company
Division
U.S. Y N N Y Depends  on  CIA Y North	
  America
U.K.
Y N Y Y Y N
Vaccines Division,	
  
Main	
  Pharma,	
  
Specialty	
  Subsidiary
France N Y Y Y N Y Distributor
Romania Y N Y Y Y Y Distributor
Japan   Y N N Y Y N
Direct	
  Sales	
  – World
Wide	
  
Portugal Y Y Y Y N Y Distributor	
  
Australia Y N Y Y Y Y Australia	
  Subsidiary
Canada N N N N N N
Main	
  Pharma –
Canada
CURRENT
PROCESS
SFA,	
  iPAD,ERP
Legal,	
  Compliance	
  
Tracking
N/A Ag	
  Spend	
  System N Ag Spend	
  System
US,
Vaccines	
  Division
COMPANY	
  
POLICY	
  
Interactions	
  with	
  
HealthCare	
  
Professionals	
  – US	
  
Transparency
Reporting	
  -­‐ US
N/A N
Transparency
Reporting	
  – US
Data Privacy	
  and	
  
Information	
  
Governance	
  – US/EU	
  
Safe	
  Harbor	
  
Data Privacy	
  and	
  
Information	
  
Governance	
  – US/EU	
  
Safe	
  Harbor	
  
ALL	
  
Bridge  the  
gaps
Scaling  and  Aligning  Business  Practices
Pending	
  image	
  
from	
  KCN
Invest  in
the  right  
human  
capital
Scaling  and  Aligning  Business  Practices
Driving  alignment  across  the  Global  Organization
Do	
  we	
  all	
  
understand	
  the	
  
objectives?
Do	
  we	
  have	
  the	
  
right	
  tools?
Does	
  anything	
  
need	
  to	
  change?
How	
  do	
  you	
  
account	
  for	
  
them?
What	
  are	
  the	
  
unique	
  business	
  
practices	
  from	
  
country	
  to	
  
country?
Five  Pillars  for  Global  Success
Best  Practices  for  
Auditing  and  Monitoring
Develop  an  annual
Audit  +  
Monitoring  
Plan…
…and  stick  to  it.
Best  Practices  for  Auditing  and  Monitoring
What  do  your  
efforts
reveal?
Examining  Your  Reportable  Data
The  Power  of  Analytics
Where  does  your  
FMV  stack  up?
Where  do  we  spend?
Have  we  
identified  any  
concerns?
Five  Pillars  for  Global  Success
Why  communicate  and  educate?
Understanding  of  the  U.S.  Sunshine  Act
37%
47%
16%
Question:  Please  rate  your  familiarity  with  the  Physician  Payment  Sunshine  Act.  
Only  37%  of  
physicians  were  
“very  familiar.”
Source:  2014  MedPanel Survey  of  456  physicians
Why  communicate  and  educate?
• Reinforce  transparency  as  a  positive  
development  for  manufacturers,  
healthcare  providers,  and  patients
• Increase  understanding  of  transparency  
requirements  and  scope  by  HCP’s  and  
HCO’s
• Proactively  share  changes  in  healthcare  
regulations  and  company  policies
• Educate  internal  and  external  
stakeholders  on  their  roles  and  
responsibilities
• Increase  willingness  of  physicians  to  
consent  to  sharing  their  TOV  information
Why  communicate  and  educate?
Drive  home  the  
concept  that  
transparency  is  
good  for  all
Best  Practices  for  
Communication  
and Education
image
Develop	
  and	
  implement	
  a	
  comprehensive	
  plan	
  
in collaboration	
  with	
  stakeholders	
  
Address  both  
internal
and
external
constituents
Best  Practices  for  Communication  &  Education
Develop  and  deliver  
targeted training  
that  includes
foundational  
information
and  “how-­to’s”
Best  Practices  for  Communication  &  Education
Integrate
existing
educational  
materials
Best  Practices  for  Communication  &  Education
Embrace  a  
“touchpoint”  
approach
Best  Practices  for  Communication  &  Education
Track  
uptake  
and  adjust  
your  approach
Best  Practices  for  Communication  &  Education
The  Future  of  Transparency
Pete  Sandford
Executive  Vice  President  and  
Co-­founder
NXLevel  Solutions
psandford@nxlevelsolutions.com
Thank  you!
Katherine  Norris
Director,  Corporate  Compliance  and  
Risk  Management
Berkeley  Research  Group
knorris@thinkbrg.com
Visit  NXLevel  Solutions  in  Booth  204  
at  the  Sixteenth  Annual  
Pharmaceutical  Regulatory  and  
Compliance  Congress,  October  21-­23
Visit  Berkeley  Research  Group  in  
Booth  6  at  the  Sixteenth  Annual  
Pharmaceutical  Regulatory  and  
Compliance  Congress,  October  21-­23

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The Future of Transparency: Five Pillars for Global Success

  • 1. The  Future  of  Transparency:   5  Pillars  for  Global  Success October  15,  2015
  • 2. Pete  Sandford Executive  Vice   President  and   Co-­founder NXLevel  Solutions Welcome Through  its  PharmaCertify™ division,  NXLevel   Solutions  delivers   innovative  and  practical   learning  and  information  solutions  to   compliance   organizations  in  the   pharmaceutical   and  medical  device  industries. Berkeley   Research  Group,  LLC  is  a  leading  global   strategic  advisory  and  expert  consulting  firm  that   provides  strategic  advice,   independent  expert  testimony,   litigation  and  regulatory  consulting,  authoritative  studies,   and  document  and  data  analytics   to  major  law  firms,   Fortune  500  corporations,  government  agencies,   and   regulatory  bodies  around  the  world.   Katherine  Norris Director,  Corporate   Compliance  and  Risk   Management Berkeley  Research  Group
  • 3. • A  Brief  History  of  Transparency   Reporting • Transparency  Reporting  today • Five  Pillars  to  Steer  You  Into  the   Future • Q  &  A Our  Agenda: The  Future  of  Transparency:  Five  Pillars  for  Global  Success
  • 4. Major  Milestones  in  Transparency  Reporting 2016  &   Beyond20152014201320122011 2010  &   Earlier EFPIA  Disclosures   Published  (2016) EFPIA  Data  Collection   Begins  (Jan.  2015) Australia  Medicines   Code  Revised  for   Enhanced  Disclosures   June  2015) EFPIA  Code   Implemented  (6/13) Loi  Bertrand  First   Disclosures  Due   (Aug.  2013) Loi  Bertrand   amended  to   require  assigned   value  to  HCP   contracts   (Feb.  2015) Loi  Bertrand   Reporting  Begins  and   is  Retroactive  to   2012  (May  2013)   US  OIG  Compliance  Guidance  Released   (5/03)   JPMA  Code  (4/08)   US  Open  Payments  adopted  as  part  of  the   PPACA  (2010)   US  companies  with  CIAs  are  required  to   disclose  certain  transparency  information   related  to  grants  and  charitable   contributions Open  Payments   Reporting  Begins   In  2  Phases   (Feb.-­‐June  2014) Australia   Medicines  Code   Adopted   (June  2014) Australia  Medicines   Code  Revised  to   Include   Transparency   Reporting   Requirements   (June  2012) State  Reporting  Requirements   (CA  – 1995,  MA  – 2009,  MN  – 1993)   PhRMA Code  Implemented  (2002) Preliminary  drafts  of  Physician  Payments   Sunshine  Act   (2007,  2008,  2009)   Open  Payments   Disclosures   Published   (Sep.  2014)
  • 5. Number  of   countries   currently   publishing   data 4 Where  are  we  now?
  • 6. Number  of   countries   publishing   data   in  2016 36 Where  are  we  now?
  • 7. Number  of   countries  with   statutory   transparency   codes 6 Where  are  we  now?
  • 8. Number  of   countries  with   voluntary     transparency   codes 37 Where  are  we  now?
  • 10. HCP  &  HCO Concerns • Negative  impact  on  ability  to  attain  or  keep   research  grants   • Reduced  opportunities  for  research  and   consulting • Worry  about  adhering  to  conflict  of  interest   policies • Changing  COI  policies   • Misinformation • Education  and  Awareness • Time  consuming  registration,  review  and   dispute  processes • Dissention  with  hospitals The  Current  Environment
  • 11. Manufacturer   Challenges • Time  and  effort  to  resolve  disputes • Communication  and  training  not  “sticking” • Managing  recording  and  reporting  from   various  business  units • Collection  from  third  parties  can  be   unreliable,  resulting  in  data  inconsistencies • Poor  understanding  of  actual  requirements   of  law;  incorrect  assumptions  =  bad  data • Perception  that  transparency  requirements   are  bureaucratic  and  not  beneficial The  Current  Environment
  • 12. The  Future  of  Transparency
  • 13. Polling  Question:   What  is  your  company’s  biggest   concern  about  global   transparency  reporting?
  • 14. Five  Pillars  for  Global  Success
  • 15. Best  Practices  for   Global  Awareness
  • 16. Getting  to  Know  Your  Global  Business   Think  globally,   act  locally... • Where  do  you  operate? • What  are  the  corporate  structures   in  those  countries? • What  legal  and  voluntary  code   disclosure  requirements  exist? • Are  your  current  businesses:   • Subject  to  applicable  requirements? • Aware  of  requirements? • Resourced? • Operating  independently?   • Using  corporate-­‐wide  infrastructure? • Who  are  your  points  of  contact?
  • 17. Getting  to  Know  Your  Global  Business   Putting  Pen  to  Paper:   What  Do  You   Need  to  Know?
  • 18. Best  Practices  for  Global  Awareness Form  a  global   transparency   steering   committee
  • 19. Best  Practices  for  Global  Awareness Establish  and   maintain  a process  &  cadence   for  global   environment   scans
  • 20. Country Law  or   Industry   Code Individual  or   Aggregate   Reporting Applicability  –HCPs,  HCOs Reported  Items TOV  Thresholds Notes United   Kingdom Industry   Code Individual  -­‐ encourages   contractual   agreement  for   individual  disclosure HCPs  -­‐ physician,  nurses,  dentist,   pharmacist HCO  -­‐medical  societies   Travel,  Education,   R&D,  Meals,  Gifts,   Hospitality None  at  this  time NHS Contemplating   HCP  driven  disclosures   France Law Individual HCP  -­‐ physician,  nurse,   pharmacist,  medical  students,   software  developers  and  more Benefits  (meals,  gifts,   travel,  etc.)  and   Contracts  with  HCPs Benefits  -­‐ equal  to  or   greater  than  €10 Contracts-­‐Notification   of  contract  and  its   value Portugal Law Individual HCPs,  HCO,  Patient  Organisations Sponsorship,  funding €65 Netherlands Industry   Code Aggregate HCPs,  institutions,  partnerships Meals,  contracts,   travel  etc.  R&D   excluded TOVs  over  €500/  year TOV  data  published  in   a  central  database. Data  must  be   submitted  in  first  3   months  of  the  year Estonia Law Individual HCPs All  non-­‐clinical  HCP   engagements In  excess  of  €6.48 Denmark   Law Individual HCPs Name,  address,  and   civil  registration   number  of  any   physician  or  dentist   associated  with  the   company.   Additional  detail  about   financial  relationships   may  be  requested  by   the  Danish  Medicines   Authority. Law Individual HCPs TOVs  for  marketing   and  non-­‐monetary  
  • 21. Best  Practices  for  Global  Awareness Proactively   adapt   to  global   developments
  • 22. Managing  Global  Transparency:  A  Continuum GlobalRegionalLocal Variables People Processes Policies Controls Tracking  &   Reporting Systems   &Tools
  • 23. Five  Pillars  for  Global  Success
  • 25. 51  percent   of  surveyed  physicians  who  visited  the   CMS  Open  Payments  site   found inaccuracies  in   the  data Why  Manage  Pre-­disclosure? Data Accuracy -­‐ 2014  MedPanel Survey  of  461  Physicians
  • 26. Dispute   Channel 85  percent   of  physicians  would  like  a   channel  to  dispute   payments  prior  to   reporting  and  public  disclosure. Why  Manage  Pre-­disclosure? -­‐ 2012  Regulatory  Law  Group  Survey  of  50,000  Physicians
  • 27. Online Portal   Access 61  percent   of  physicians  would  access   an  online  portal  to   proactively  review  and  manage   financial  data  to  be  reported. Why  Manage  Pre-­disclosure? -­‐ 2012  Regulatory  Law  Group  Survey  of  50,000  Physicians
  • 28. Does  your   company  have  a   formal  TOV   pre-­disclosure   process  in  place? Your  Perspective… Polling   Question
  • 29. Why  Manage  Pre-­disclosure? •To  ensure  data  accuracy   •To  resolve  disputes  before   data  goes  public •To  build  partnership •To  increase  consent  of  HCP’s   where  required
  • 30. Best  Practices  for   Managing   Pre-­disclosure
  • 31. Best  Practices  for  Managing  Pre-­Disclosure Develop  and   implement   SOP’s  in   partnership  with   business   stakeholders
  • 32. Best  Practices  for  Managing  Pre-­Disclosure Establish  a   communication   “triangle” with  key   customers
  • 33. Best  Practices  for  Managing  Pre-­Disclosure Provide  a   streamlined   platform   for  HCP’s   and  HCO’s   to  view  and   inquire   Click  on  a  payment  below  to  view  details  and  inquire. HCP  Statement
  • 34. Five  Pillars  for  Global  Success
  • 35. Best  Practices  for   scaling  and  aligning   business  processes
  • 36. Build  and   follow  a   roadmap Scaling  and  Aligning  Business  Practices  
  • 37. Great Falls  Pharma  – Global  Transparency  Assessment   Country Voluntary Code   Statutory   Requirement   Prior  Consent Individual Reporting   Company   Website   Central   Repository Company Division U.S. Y N N Y Depends  on  CIA Y North  America U.K. Y N Y Y Y N Vaccines Division,   Main  Pharma,   Specialty  Subsidiary France N Y Y Y N Y Distributor Romania Y N Y Y Y Y Distributor Japan   Y N N Y Y N Direct  Sales  – World Wide   Portugal Y Y Y Y N Y Distributor   Australia Y N Y Y Y Y Australia  Subsidiary Canada N N N N N N Main  Pharma – Canada CURRENT PROCESS SFA,  iPAD,ERP Legal,  Compliance   Tracking N/A Ag  Spend  System N Ag Spend  System US, Vaccines  Division COMPANY   POLICY   Interactions  with   HealthCare   Professionals  – US   Transparency Reporting  -­‐ US N/A N Transparency Reporting  – US Data Privacy  and   Information   Governance  – US/EU   Safe  Harbor   Data Privacy  and   Information   Governance  – US/EU   Safe  Harbor   ALL  
  • 38. Bridge  the   gaps Scaling  and  Aligning  Business  Practices Pending  image   from  KCN
  • 39. Invest  in the  right   human   capital Scaling  and  Aligning  Business  Practices
  • 40. Driving  alignment  across  the  Global  Organization Do  we  all   understand  the   objectives? Do  we  have  the   right  tools? Does  anything   need  to  change? How  do  you   account  for   them? What  are  the   unique  business   practices  from   country  to   country?
  • 41. Five  Pillars  for  Global  Success
  • 42. Best  Practices  for   Auditing  and  Monitoring
  • 43. Develop  an  annual Audit  +   Monitoring   Plan… …and  stick  to  it. Best  Practices  for  Auditing  and  Monitoring
  • 44. What  do  your   efforts reveal? Examining  Your  Reportable  Data
  • 45. The  Power  of  Analytics Where  does  your   FMV  stack  up?
  • 46. Where  do  we  spend? Have  we   identified  any   concerns?
  • 47. Five  Pillars  for  Global  Success
  • 49. Understanding  of  the  U.S.  Sunshine  Act 37% 47% 16% Question:  Please  rate  your  familiarity  with  the  Physician  Payment  Sunshine  Act.   Only  37%  of   physicians  were   “very  familiar.” Source:  2014  MedPanel Survey  of  456  physicians
  • 50. Why  communicate  and  educate? • Reinforce  transparency  as  a  positive   development  for  manufacturers,   healthcare  providers,  and  patients • Increase  understanding  of  transparency   requirements  and  scope  by  HCP’s  and   HCO’s • Proactively  share  changes  in  healthcare   regulations  and  company  policies • Educate  internal  and  external   stakeholders  on  their  roles  and   responsibilities • Increase  willingness  of  physicians  to   consent  to  sharing  their  TOV  information
  • 51. Why  communicate  and  educate? Drive  home  the   concept  that   transparency  is   good  for  all
  • 52. Best  Practices  for   Communication   and Education image
  • 53. Develop  and  implement  a  comprehensive  plan   in collaboration  with  stakeholders  
  • 54. Address  both   internal and external constituents Best  Practices  for  Communication  &  Education
  • 55. Develop  and  deliver   targeted training   that  includes foundational   information and  “how-­to’s” Best  Practices  for  Communication  &  Education
  • 56. Integrate existing educational   materials Best  Practices  for  Communication  &  Education
  • 57. Embrace  a   “touchpoint”   approach Best  Practices  for  Communication  &  Education
  • 58. Track   uptake   and  adjust   your  approach Best  Practices  for  Communication  &  Education
  • 59. The  Future  of  Transparency
  • 60. Pete  Sandford Executive  Vice  President  and   Co-­founder NXLevel  Solutions psandford@nxlevelsolutions.com Thank  you! Katherine  Norris Director,  Corporate  Compliance  and   Risk  Management Berkeley  Research  Group knorris@thinkbrg.com Visit  NXLevel  Solutions  in  Booth  204   at  the  Sixteenth  Annual   Pharmaceutical  Regulatory  and   Compliance  Congress,  October  21-­23 Visit  Berkeley  Research  Group  in   Booth  6  at  the  Sixteenth  Annual   Pharmaceutical  Regulatory  and   Compliance  Congress,  October  21-­23