Operational Considerations for Transparency. September 2011

Transcription

1 Operational Considerations for Transparency September 2011

2 Current Global Regulatory Trends Type of Regulations/ Guidance Company s obligations Scope Sanctions/ Penalties State Laws Promotional spend reporting and public disclosure U.S. Financial penalties Federal Law (PPACA 6002) Promotional spend reporting and public disclosure U.S. Financial penalties ABPI (UK Pharma Assoc.) Speaker, consultant, ad board fees reporting UK Self regulation France Law Fall 2011 Spend data reporting and public disclosure France TBD CGR/Netfarma (Dutch Pharma. Association) Spend data reporting and public disclosure Netherlands Self regulation JPMA (Japan Pharma Assoc.) Spend data reporting and public disclosure Japan Self regulation Australia (Medicines Australia Assoc.) Spend data reporting and public disclosure Australia Self regulation UK Bribery Act Adequate anti-bribery preventive measures UK / Global? Financial penalties / civil and criminal prosecution Foreign Corrupt Practices Act (FCPA) Clean Books of records Anti-bribery measures Global Financial penalties / civil and criminal prosecution 2 This document should not be distributed without Cegedim authorization Copyright 2011

3 Japan vs. US Transparency & Disclosure Comparison JPMA Spend Data Yearly Tracking Total Aggregated Payments for R&D Total Aggregated Payments for providing information to Congress / Meetings Total Aggregated Payments for Entertainment Research Funding & Grants, by Organization Manuscript writing fees & Consulting fees, By Individuals Data Reported in 2013 Review by Doctors Disclose on pharmaceutical companies web site after the financial year closing (no obligation to report to JPMA) US Reporting to Federal Government Individual Payments to Physicians and Teaching Institutions (Hospitals) Consulting fees, honoraria Gift, entertainment, food Travel (including the specified destinations) Education, research Charitable contribution, grant Royalty or license; Current or prospective ownership or investment interest; Direct compensation for serving as faculty or as a speaker for a medical education program $10 & Greater or >$100 in Total 2012 Data Reported in 2013 Review by Doctors Final Report Template Not Provided Yet by Federal Government Drug Samples Also Required to be Reported to Federal Government Starting in 2012 This document should not be distributed without Cegedim authorization Copyright

4 FCPA General Overview Elements of a FCPA Violation A covered person / entity Registered securities in US ADRs on US Stock Exchange Must offer or give something of value Includes offer or promise To a foreign official Health care providers and other employees of government owned health care institutions are routinely considered to be foreign officials Payment To obtain or retain business With corrupt intent To induce foreign official to abuse or misuse his/her position or authority through action or inaction Affirmative Defenses Payments authorized by written foreign law Informal Business Customs Bona fide business expenditures Reasonable and made in good faith Accounting Provisions Books and Records Internal Controls This document should not be distributed without Cegedim authorization Copyright

5 FCPA Compliance Practices to Help Prevent Corruption Implementing written policies and procedures Designating a compliance officer and compliance committee Conducting effective training and education Developing effective lines of communication Conducting internal monitoring and auditing Including Transparency - Internal / External Enforcing standards through well publicized disciplinary guidelines Responding promptly to detect problems and undertake corrective This document should not be distributed without Cegedim authorization Copyright

6 What Life Sciences companies are looking for Develop an end to end Commercial Compliance solution that will meet regulatory requirements and support compliance and business internal needs Promote self regulation and establish compliance processes to the highest standards Proactive monitoring, Preventive measures, information tracking and centralization Achieve internal transparency before regulation grow more stringent How, and how much companies are spending on HCPs, HCOs, and other related entities From spend data reporting to the Authorities to Public disclosure Provide a new data insight to the organization to refine business strategies and tactics Unified view of spend data at individual level This document should not be distributed without Cegedim authorization Copyright

7 What are the operational processes to acheive internal transparency and data disclosure? AN OPERATIONAL CHALLENGE This document should not be distributed without Cegedim authorization Copyright

8 The Transparency Drivers Knowledge on local and global regulations Systems and data solutions Accurate and available information Risk- focused business eco system Entreprise wide management Effective Transparency program enables companies to uncover emerging compliance issues before they become a problem This document should not be distributed without Cegedim authorization Copyright

9 On-going Operational Cycle of Transparency Data Posting Spend Data Positing on the Internet based on regulatory requirements Spend Reporting Spend Data Reporting based on local or global regulatory requirements Spend recipients acknowledgment Spend data send to covered recipients for acknowledgement Comply with regulations Align your Processes Align Transparency Know your Customers Evaluation Internal Spend Data sources External Spend Data sources Type of Data to capture Alignment File management (data alignment, de-duplication, standardization) Data management ongoing processing and validation governance Compliance data Master Local and international data file matching process Customer data validation and verification Development of a unique and global data master Aggregation Aggregation to a uniquely identified Customer Internal Data presentation and review Risk Assessment Evaluate Compliance risk at individual level This document should not be distributed without Cegedim authorization Copyright

10 On-going Operational Cycle of Transparency Comply with Regulations Align your Processes Align Transparency Know your Customers Evaluate, Standardize, Streamline This document should not be distributed without Cegedim authorization Copyright

11 Transparency is an Operational Challenge Sales & Marketing Gifts, Meals, S&M Customer expenses, samples Fee for Service arrangements Advertising Patient education Conventions R&D and Medical Affairs Clinical trials Fee for Service arrangements Medical Liaison Customer Expenses Medical Publications Medical Information Corporate Affairs Charitable Contributions Advocacy Corporate Memberships Grants Sponsorships Fellowships Third Party Vendor/Partners Market Research Vendor-managed Programs CME Clinical trials Geographies Products Business Units Customers Employees Vendors Different ways of reporting and capturing data Different IT systems Rapid architecture change through Mergers, Acquisition or Joint Ventures Multiple external vendors and partners (sales agents, market research companies, travel agencies ) This document should not be distributed without Cegedim authorization Copyright

12 Designing Transparency Foundations Process standardization and integration Define standard policy and business rules Streamline, align and automate processes Integrate on-going monitoring and internal controls Information management Identify Data point (what data to be captured) Establish a data governance (how, when & where data is captured and integrated) Enterprise-wide master data management and integrated data validation processes Transparency rules Determine Aggregate Spend business rules Establish open and transparent communication with the HCP This document should not be distributed without Cegedim authorization Copyright

13 On-going Operational Cycle of Transparency Comply with Regulations Align your Processes Align Transparency Know your Customers Identify, Validate, Inform This document should not be distributed without Cegedim authorization Copyright

14 Customer Information Transparency projects require thorough customer information management A consistent global customer database which includes all entities to be reported (physicians, patient association, public officials) along with the related information (multi-addresses, contact information, specialties) A thorough master data governance process for covered recipient data management and unique identification across systems An fully integrated customer data validation to ensure report accuracy, risk management optimization and conflict of interest prevention Personal Data protection regulation on going management This document should not be distributed without Cegedim authorization Copyright

15 Risk Assessment through Customer Knowledge Individual risk assessment Expertise level Customer type Organization Role & responsibility Decision making power Community Local Healthcare Providers Payers/Buyers Price & reimburseme nt agencies Drug Committees Head of P&T committee Committee member Relationships and influences Under Contract Regional International Administrative Associations Government owned Hospitals / Clinics GPOs / Group practices Purchasing manager Executives Global Identification Affiliation Profiling This document should not be distributed without Cegedim authorization Copyright

16 Customer Master Data Management Why is Customer Data Management such a challenge? Organizations have different ways of reporting and capturing data Multiple representations exist for the same entity/attribute Organizations use different IT systems Organizations change rapidly(mergers/acquisition/joint Ventures) as well as, business needs Reference Data integration is complex How can it be overcome Establish a common definition of the Customer Employ Data Governance into the enterprise Who owns? Integrate Customer information across the enterprise Keep the Customer data fresh with reference sources Stress the value/use of the integrated repository and the system-ofrecord (Best Of Breed) This document should not be distributed without Cegedim authorization Copyright

17 The Aggregate Spend Context The thought of trying to unify and create a unique instance of the customer for Aggregate Spend Process is a challenge that often is underestimated or misinterpreted. This document should not be distributed without Cegedim authorization Copyright

18 On-going Operational Cycle of Transparency Comply with regulations Align your processes Align Transparency Know your Customers Alert, Report, Disclose This document should not be distributed without Cegedim authorization Copyright

19 The Right Balance as a Strategy In the long run, Authorities as well as HCPs will hold companies accountable for documenting their interactions with Healthcare professionals Industry Investments HCPs / Authorities Reasonable Understandable Acceptable Legitimate Supported Accepted Understood This document should not be distributed without Cegedim authorization Copyright

20 Transparency Q & A Fragmented Information system and redundant business processes across the enterprise? Ever changing risk environment? Confidence in internal data reporting, analysis and alerts? Internal Transparency program buy-in? Automate data integration processes to a centralized unique data repository to ensure information completeness and immediate availability Favor the implementation of a configurable (no customization) and agile risk monitoring solution allowing scalability to quickly adapt to emerging requirements Embed data verification and validation process and increase data consistency, integrity and quality as data is sourced, transformed and managed Leverage the data required for Compliance requirements to increase the effectiveness of business stakeholders by enhancing internal reporting capabilities and metrics This document should not be distributed without Cegedim authorization Copyright

21 Transparency Global Program Key Points Enterprise Level Bribery Risk Assessment that uses technology to flag / alert potential bribery risks associated with public officials, P&T committee members as well as third parties such as joint venture partners An Internal Spend Control System to ensure that all payments, such as reimbursements, expenditures, gifts, promotional materials, samples and in- kind transactions are accurately recorded in the organization s books and records. This document should not be distributed without Cegedim authorization Copyright 2010 Assessing Risk on a continuous basis - Tracking Spend Data consistently and accurately across countries 21

22 Thank You for Your Attention This document should not be distributed without Cegedim authorization Copyright