Latin America. Fair Market Value Update

Transcription

1 Latin America Fair Market Value Update 1 st Latin American Pharmaceutical and Device Compliance Congress Sao Paulo, Brazil 3 October2012

2 International FMV Why create consistent payment methodology? World is focused on bribery Anti-corruption legislation FCPA UK Bribery Act Increased enforcement efforts Corporate risk Individual risk Impact on business Exclusion from public contracts Reputational damage Damage to market valuations Loss strategic business opportunities Page 3

3 Proactive anti-corruption approach to FMV Establish robust business process to minimize risks of improper influence / corruption Proactive approach is a compliance program that includes a FMV process for developing, assessing, and supporting FMV compensation of business partners Although a proactive approach cannot guarantee there will not be problems, it can greatly mitigate risk and place Company in a better position to request leniency from the government should a violation occur Key processes to developing a proactive approach: Identify third-party business partners that may be at higher risk Understand Company s interactions with third-parties Understand compensation structure Establish robust process for reviewing business need / justification Establish FMV compensation through a standardized / monitored process Page 4 4

4 FMV Challenges for Latin American markets Availability of external data FMV expertise Highly diverse healthcare / laws / cultural norms Frequency / speed of market changes Domestic company competitive advantages Industry association restrictions Industry / stakeholder involvement Page 6

5 FMV Stages of Evolution No system No particular strategy, approach or tracking mechanisms Rate card Group similar activities Payments based on historical payments for similar transactions FMV Process Global FMV framework Inventory and group transactions FMV analysis, models, tools Validate with external data, where available Payments tracked and monitored Multi-national need for governance at global, regional, country, company levels Standardized processes, methods Oversight, testing, monitoring Page 8

6 Global FMV pilot study one example Phase I Leveraging Successes Over two-month period: conducted 20 interviews / FMV tool demos for HCP commercial and R&D transactions FFS: Variety of methods/ tools, different look / feel / origin / multiple consultants SI: enabling tools, best practices & lessons learned Phase II Pilot Study External data research FFS Calculator / governance SI governance May - Aug 2011: conducted 50 interviews to understand current processes & tools June to Sept 2011: conducted 9 site visits - confirmed understanding of current state / tools, introduced standardized framework concepts, conducted workshops on FMV tools for FFS and SI framework Considered local country/market factors in FMV tool concept FFS market data research: very limited or not relevant; HCP compensation data, insurance reimbursement rates, Key external data sources: government statistics, third-party market surveys, industry association surveys, medical profession rate cards, benchmarking Impact of healthcare systems and reforms, local law, guidance from professional associations EY network: EY/RDPAC survey for China. Previous & ongoing surveys in EMEA, India Co-developed a standard, flexible tool with Pilot teams in 9 countries Beta tested tool with Pilot teams and refined based on feedback SI governance: toolkit templates for SOP s and tools for governance committee implementation Page 10

7 HCP Compensation What did we learn? Page 11

8 FMV FFS Methodology One example: How to determine FMV? Base Hourly Rate x HCP Specialty Multiplier x HCP Stature Multiplier x [ Service Time + Preparation Time + (Travel Time * Travel Time Discount %) ] = TOTAL FEE PER ACTIVITY Page 12

9 Experience with pilot study What did we learn? Developing a standard, global FMV process is complex and time-consuming Businesses are concerned about FMV complexity state of readiness and organizational preparedness varies greatly business size is a key factor Most companies have unvalidated FMV rate cards Most have informal governance process Eager to have tools / standard methods and underlying support for FMV FMV requires cross-functional resources many business functions are impacted Engage key stakeholders early and throughout the process Can not do FMV analysis without understanding details of services External data is highly variable availability, validity, relevance? Need standard, repeatable FMV process and methods Need formal governance / oversight at global, region, country levels Page 13

10 FMV governance model one example Assess Appropriateness of Compensation/Payment HCP Fee-for-service Exercise Oversight Sales Intermediaries Review and Approve Compensation/Payment Ensure appropriate FMV process is in place Applied consistently / administered per agreement terms and conditions Review findings from monitoring, testing, auditing, enforcement Vigilance for totality of relationships - multiple agreements with same parties Page 14

11 Building a FMV Process Define FMV and scope of services Identify cross-functional team Identify and analyze services Business justification for services and vendor Identify data for analysis Implement a FMV process / analysis Document FMV process / conclusion Page 15

12 Assess your approach to FMV Key considerations Determining FMV is challenging, complex, and time-consuming Focus on benefits / advantages to the business significant efficiencies Engage key stakeholders early and throughout process many business functions are impacted Can not do FMV analysis without understanding details of services Determine company involvement and consider outside consultants to assist / advise on FMV process and to help with external data Develop standard, repeatable FMV process and methods driven by data and sustainable by the business Develop governance / oversight at global, region, country levels Educate, train, and maintain internal FMV resources Periodically review / update FMV process and valuation models Page 16

13 FMV is a journey It s about process and accuracy over time Process Improves Precision Fee schedules Rate cards FMV models Governance and oversight Data Collection, Analysis, Calibration Improves Accuracy Nature of services or arrangements Market / industry data Competitive information Government studies Page 17

14 Latin America Fair Market Value Update Today s Discussion Panel Bridget Bourgeois, Partner, Valuation, FMV Leader Ernst & Young LLC bridget.bourgeois@ey.com Sergio Pinto, MBA, CCEP, Director, Health Care Compliance Brazil sepinto@its.jnj.com Page 18