Confidence in your hands Compliance Training Strategies in

Confidence in your hands ™ 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 Gmb. H, Switzerland 1 Protect our employees, our partners, our company

Confidence in your hands ™ 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. 2 Protect our employees, our partners, our company

Confidence in your hands ™ 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! 3 Protect our employees, our partners, our company

Confidence in your hands ™ 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. 4 Protect our employees, our partners, our company

Confidence in your hands ™ 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 payer’s money) Request of more transparency on the buying decision process (conflict of interest of the HCP) 5 Protect our employees, our partners, our company

Confidence in your hands ™ General Overview Expensive health Great Britain 2, 7 Japan 2, 9 Italy 1, 0 Denmark 1, 1 Holland 0, 6 Australia 0, 8 Sweden 1, 3 Canada 1, 1 France 0, 3 Germany 0, 5 Switzerland 1, 9 USA 1, 7 Growth 1990 -2002 percentage 6 % Healthiness cost 2002 % gross domestic product Protect our employees, our partners, our company

Confidence in your hands ™ Medical Device specifics that compliance is 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 patient’s indication and the trust in the quality of the product! 7 Protect our employees, our partners, our company

Confidence in your hands ™ Compliance is also dealing with: • Anti Bribery laws incl. FCPA • • • Key Elements of Zimmer’s Corporate Compliance Program: Laws / Regulations Zimmer Values Zimmer Policies (ZP) & Procedures (SOP); CCP Corporate Compliance Program Other guidelines like Ph. RMA Code, Adva. Med Code, Eucomed, Business Ethics The Compliance Program is values driven and has a legalistic approach Additional guidance: Always apply the strictest law! 8 Protect our employees, our partners, our company

Confidence in your hands ™ 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 • 9 Medicare Program in the U. S. Personal risk: fine, imprisonment Protect our employees, our partners, our company

Confidence in your hands ™ What is the Corporate Compliance Officer’s 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. 10 Protect our employees, our partners, our company

Confidence in your hands ™ 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. ) 11 Protect our employees, our partners, our company

Confidence in your hands ™ 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 12 Protect our employees, our partners, our company

Confidence in your hands ™ Content of the Compliance Training Workshop • Cases with practical examples • Q&A Corporate Compliance Program & General overview Basic Compliance Training • History of Compliance • Definition 13 Protect our employees, our partners, our company

Confidence in your hands ™ General Enforcement tools Individual one-to-one training Group training and workshops E-learning tools for interactive intranet based training programs Compliance Office Webcasts interactive presentation format that is delivered via intranet 14 E-mail and Compliance website as a communication tool Protect our employees, our partners, our company

Confidence in your hands ™ Compliance Training is only a part of the whole global process Risk Assessment Controls & Mitigation Compliance Audits & Monitoring Program incl. Training 15 Protect our employees, our partners, our company

Confidence in your hands ™ What are the benefits of Training? • It gives the trained person confidence in decisionmaking 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 company‘s 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. 16 Protect our employees, our partners, our company

Confidence in your hands ™ Crucial factors of a Global Compliance Program • Measure the training through tests (evaluation & • • 17 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. ) Protect our employees, our partners, our company

Confidence in your hands ™ 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 static> It undergoes regular changes and improvements • Training should also have interactive components for the better assimilation 18 Protect our employees, our partners, our company

Confidence in your hands ™ Thank you for your attention! 19 Protect our employees, our partners, our company