Operational Impacts of Transparency Initiatives on Life ...of spend data. EFPIA . disclosure Code of...
13
Operational Impacts of Transparency Initiatives on Life Sciences companies based in APAC François Benelli, Cegedim Diva Duong, Cegedim Kuala Lumpur, 11 th of Sept, 2013
Transcript of Operational Impacts of Transparency Initiatives on Life ...of spend data. EFPIA . disclosure Code of...
Operational Impacts of Transparency Initiatives on Life Sciences companies based in APAC
François Benelli, CegedimDiva Duong, Cegedim
Kuala Lumpur, 11th of Sept, 2013
2|
Agenda
This document should not be distributed without Cegedim authorization – Copyright 2013
Transparency Landscape2012 APAC Compliance surveyAggregate Spend SystemCustomer Master DataSpend Data AggregationOperational Cycle of TransparencyRecommended System Functionalities
3|This document should not be distributed without Cegedim authorization – Copyright 2013
U.S. Sunshine Act Final Rule
Transparency in APAC is at the forefront Following U.S. and Europe standards
Jan. 2012Jan. 2011 Jan. 2013
Update on Chinese RDPAC Code of Practice
Medicines Australia New Transparency Guidelines
Launch of JPMA Transparency Guidelines
Enforcement of UK Bribery Act
Japan FTC Guidelines on Hospitality and Gifts
Enforcement of revised IFPMA Code of Practice
Aug. 2013
French Sunshine Act
Japan first disclosure of spend data
EFPIA disclosure Code of transfers of value
4|This document should not be distributed without Cegedim authorization – Copyright 2013
2012 Cegedim APAC Compliance survey Key takeaways
In 2012, pharma companies address spend data transparency challenges locally (independently from HQ)Spend data reporting:
Manual spreadsheets was cited by 49% of respondentsERP and accounting systems were cited by 61% of respondents
Increased demand from the authorities leads companies to evaluate global aggregate spend systems to monitor HCP interactions more efficiently and respond timely to growing disclosure requirements The U.S. & European Transparency and Aggregate Spend model is likely to spread across APAC region87% of respondents believe Transparency represent a major operational and organizational challenging during 2013-2014.The U.S. experience:
A lack of anticipation and management of Transparency can lead to system/process shortcomings that have long lasting effects
A lack of anticipation and management of Transparency can lead to system/process shortcomings that have long lasting effects
5|This document should not be distributed without Cegedim authorization – Copyright 2013
Aggregate Spend System Why is it worth the investment?
Having a Compliance program is not enough. MR may not follow the rules.
Administrative fines can be imposed and Company reputation may be affected.
Aggregate Spend reporting solution can provide :the necessary alerts on suspicious payments the reports to detect risks before they become a problemthe spend data monitoring at HCP, HCO, employee, meeting, drug or country level, through an easy-to-use interface
6|This document should not be distributed without Cegedim authorization – Copyright 2013
Alerts
Predefined reporting
Customized reporting
Data analysis
Business Decisions
Disclosure
Alerts
Predefined reporting
Customized reporting
Data analysis
Business Decisions
Disclosure
Output info.Import Data
Spend Data Extraction and
Formatting
Spend Data systems
ERP, Travel and Expenses, etc.
Spend Data systems
ERP, Travel and Expenses, etc.
Aggregate Spend SolutionHigh-level architecture
Requests for Engagements,
Grants, Donations
Requests for Engagements,
Grants, Donations
CRM
Meetings and Congresses
CRM
Meetings and Congresses
Import D
ata
Customer Master Reference (Healthcare database)
Customer Master Reference (Healthcare database)
Aggregate Spend
Repository
Aggregate Spend
Repository
Unique Customer ID, complete and accurate
Expense with HCP ID
+
Spend data integration, validation and management
7|This document should not be distributed without Cegedim authorization – Copyright 2013
R&D Expenses• Joint research• Contract research • Clinical study • Post-marketing clinical trial• Adverse drug reaction reporting• Post-marketing surveillance
Academic research support expenses• Scholarship donations• General donations• Donations to academic societies• Co-sponsored conference hosting
Honoraria• Lecture fee• Manuscript writing / supervision fee• Consulting/commissioning fee
Information provision-related expenses • Lecture expenses• Explanatory meeting expenses• Supply of medical/pharmaceutical literature
GeographiesGeographies
ProductsProducts
Business UnitsBusiness Units
CustomersCustomers
VendorsVendors
Common problems:Not all data elements captured in the source systemsNo single HCP or HCO identifierIncomplete HCP profileDifficulties implementing business requirementsDisparate data formatsChanging business and regulatory environmentLack of visibility when HCPs are engaged by out- of-country affiliates
Spend Data Aggregation Operational Challenge
Other Expense• Hospitality• Social courtesy • Entertainment
8|This document should not be distributed without Cegedim authorization – Copyright 2013
IT Transparency initiative Driven by Global and Local requirements
Support Resources
Support Resources
Local Processes and Systems
Local Processes and Systems
Language & Cultural differences
Language & Cultural differences
Global Governance
Common Processes & Tools
Company Code of Conduct
Global Regulations
Global NeedsGlobal Needs Local NeedsLocal Needs
Local Regulation
VS
9|This document should not be distributed without Cegedim authorization – Copyright 2013
Customer Master Data Necessity to get unique ID!
Common challenges include out-of-date and incomplete data, duplicates within a country or across countries, difficulties in mapping Finance System (ERP) with other tracking systems…Solution:
Cleansing , de‐
duplication and
enrichment
Data file matching and on-going management
Unique ID assignmentCustomer Data Record enrichment
Key Data attribute validation
EXTERNAL
ID#1
INTERNAL ID#1
EXTERNAL
ID#2
Your Data
Files
Reference
Global
Database
MKG
ERP
CRM
Daily updates
by local call
center
Daily updates
by local call
center
OneGlobal ID
Individuals Affiliations Workplaces
10|This document should not be distributed without Cegedim authorization – Copyright 2013
On-going Operational Cycle of Transparency Best practice
Align Transparency
Align your Processes
Comply with requirement
Know your Customers
Reporting / Disclosure
Aggregation
Review
Determine level of disclosure / reporting required
Submit reports to your HQ in pre-defined format
Internal teams validate expenses
Arbitrage / reconciliation with actual status of on-going activities
Aggregation of spend data to a unique Customer identifierInternal Validation rules
1
Collection
Alignment
Cleansing
List of all HCP / HCO receiving payments Internal / External Spend Data sourcesType of Expenses to capture
Customer data matching processData quality check / validationDevelopment of a unique data master file
Code mapping between spend data sources
Standard format / process to capture spend data
Common definition of nature and purposes of Expenses
2
34
5
6
11|This document should not be distributed without Cegedim authorization – Copyright 2013
Aggregate Spend System Recommended Functionalities
Configurable, country-specific reporting templates
Spend alerts based on HCP-HCO affiliation relationship
Report view in different currencies and languages
Management and reporting of agreements with HCP
Solid process for data integration.
Exception management: alerts + view into error handling
Private publication to HCP and public posting
Approval Workflow for Publication
12|This document should not be distributed without Cegedim authorization – Copyright 2013
Single-Country Implementation Average Implementation Time : 4 months
Pre‐requisite 1st
Month 2nd
Month 3rd
Month 4th
Month Key Activities
Review of requirements for AGSReview of requirements for AGS
AGS Setup & ConfigurationAGS Setup & Configuration
Go Live
Project Initiation & planning
System Configuration and Data Loading
System Integration Test and QC
Transition /Deployment
UAT User training
Field user training
Project Kick-Off
Assign unique ID per each HCP & HCO
Data ConsultingData Consulting
Match & Merge + enrichmentMatch & Merge + enrichment
Spend Data Formatting / Interface developmentSpend Data Formatting / Interface development
Data Loading into AGSData Loading into AGS
Full testing #1Full testing #1
Full testing #2Full testing #2
Move-to-production
Analysis of spend data sources and data flows
Data Management
13|This document should not be distributed without Cegedim authorization – Copyright 2013
Diva DUONGVice President Compliance [email protected]
Francois BENELLIBusiness Compliance [email protected]
