Compliance%20Training%20Strategies%20in%20a%20Global%20Setting

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• Compliance Training Strategies in a Global
  Setting
• The International Medical Device
• Compliance Congress Best Practices Forum
• May 26 - 27, 2008 Paris
• Tamara Tubin
• Compliance Manager EMEA
• ZIMMER GmbH, Switzerland

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About Zimmer

• Founded in 1927 and headquartered in Warsaw,
  Indiana, Zimmer is a worldwide leader in
  designing, developing, manufacturing and
  marketing orthopaedic reconstructive, spinal and
  trauma devices, dental implants, and related
  orthopaedic surgical products.
• Zimmer has operations in more than 25 countries
  around the world and sells products in more than
  100 countries.
• Zimmer's 2007 sales were approximately 3.9
  billion. The Company is supported by the efforts
  of more than 7,500 employees worldwide.

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What is Compliance? General Definition

The state of being in accordance (to comply)
with the relevant laws, regulations, industry
codes, policies. Compliance is also about
ethics, values and integrity!
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Why the Focus on Compliance? Change

• Change of environment
• Increase of regulations
• Increase of healthcare costs
• Ethics is getting important
• It is a response to bribery and other unethical
  conduct in corporations. Prominent case ENRON.

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Changing of Medical Device environment

• Finance industry ? Pharmaceutical ? Medical
  Device Industry
• More restrictive legislation and prosecution
• Increased responsibility of Board of Directors
  and Top Management
• Increasing Healthcare costs ? pressure on the
  cost (tax payers money)
• ?Request of more transparency on the buying
  decision process (conflict of interest of the
  HCP)

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General OverviewExpensive health

2,7 2,9 1,0 1,1 0,6 0,8 1,3 1,1 0,3 0,5 1,9 1,7
Great Britain Japan Italy Denmark Holland Australi
a Sweden Canada France Germany Switzerland USA
Healthiness cost 2002 gross domestic product
Growth 1990-2002 percentage
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Medical Device specifics that complianceis
dealing with
Various conflict of interest issues What are
the potential conflicts in the medical device
industry? Role of the decision-maker Objective
science vs. financial gain Well being of the
patient vs. financial incentives The specific
product has to be chosen according to the
patients indication and the trust in the quality
of the product!
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Compliance is also dealing with

• Anti Bribery laws incl. FCPA
• Key Elements of Zimmers Corporate Compliance
  Program
• Laws / Regulations
• Zimmer Values
• Zimmer Policies (ZP) Procedures (SOP)
• CCP Corporate Compliance Program
• Other guidelines like PhRMA Code, AdvaMed Code,
  Eucomed, Business Ethics
• The Compliance Program is values driven and has a
  legalistic approach
• Additional guidance Always apply the strictest
  law!

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Why Compliance, Ethics and Best Practices?

• Because it is the right thing to do!
• Integrity and values are key drivers of business
  success!
• We want to build confidence and trust for
  Patients, Customers and Stakeholders!
• What is the risk of Non-Compliance?
• Corporate risk reputation, fine, exclusion from
  the Medicare Program in the U.S.
• Personal risk fine, imprisonment

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What is the Corporate Compliance Officers
reporting relationship and role?

• The Compliance Office at Zimmer is independent
• The Chief Compliance Officer is a member of the
  Operating Committee and reports directly to the
  CEO and the Board of Directors.

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Challenges of a global Compliance Program

• Cultural and regional barriers/differencies
• Different mind-sets
• Language issue
• Global Compliance Policies vs. Local laws /
  regulations and industry codes
• The implementation might vary from country to
  country depending on the local law restrictions
  (i.e. use of Hotlines are restricted in Germany
  and France compared to the U.S.)

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Key elements of a global Compliance Program

• Written Policies and Procedures incl. translation
  into the relevant languages! Effective
  implementation
• Continuous training and education
• Effective lines of reporting and communication
• Monitoring and Auditing
• Prompt response to violations incl. corrective
  actions
• Compliance Officer and Compliance Committee
• Disciplinary HR guidelines (i.e. Code of Conduct)
  for non- compliant behaviour

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Content of the Compliance Training

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General Enforcement tools
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Compliance Training is only a part of the whole
global process
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What are the benefits of Training?

• It gives the trained person confidence in
  decision-making and confidence in the general
  conduct of business.
• It gives the possibility to ask questions on
  site.
• It supports long-standing company values and
  achievements.
• It promotes a companys brand to be reliable and
  trustworthy by having employees that know what is
  the right thing to do!
• It significantly reduces the risk of
  Non-Compliance.

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Crucial factors of a Global Compliance Program

• Measure the training through tests (evaluation
  certification)
• Feedback from the employees
• Measurement and reporting through audits
• Adaptation of the existing Compliance Program due
  to new laws / regulations / policies
• Keep the trainee interested also through
  newsletters and other tools
• Run refresher trainings / workshops
• Open communication while conducting trainings and
  workshops
• Customization of the compliance training to the
  according business unit (research, brand etc.)

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Conclusions

• Training is a part of a whole process
• Training should be done with passion, enthusiasm
  and commitment so that at the end of the day the
  participants are motivated and inspired
• Compliance Training is not staticgt It undergoes
  regular changes and improvements
• Training should also have interactive components
  for the better assimilation

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• Thank you for your attention!