1. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL "International congresses, including booth materials and panels, controls related to non-CME medical presentations, and interactions between commercial associates and health care professionals before/after CME events: Which guidelines apply?" Dr. José F. Zamarriego Izquierdo Paris, May 29th 2008

2. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL 1991: Adoption of the Spanish Code on the basis of EFPIA Code (adapted in 1992). 2002: Approved a much more stringent and precise new version of the Code. 2004: New version with additional measures to reinforce this self-regulation system. 2005: New adaptation, incorporating elements from EFPIA Code new version (Nov 04). 2008: Code New Version & New Code: Interaction with Patient Organizations (July 08).  INTRODUCTION  DOCUMENTS (www.farmaindustria.es)  Spanish Code Of Practice  Rules of Procedure for the Control Bodies  Implementation Guide  Queries (Questions And Answers) on the Interpretation of the Code  The Code covers all promotional actions addressed at Spanish healthcare professionals wherever they may take place (i.e. Spain, USA, South Africa, China....). THE SPANISH CODE OF PRACTICE  Applicable to members of Farmaindustria and to the pharmaceutical companies adhered to the Code.

3. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL GUARANTEE  Information available and distributed to healthcare professional able to prescribe and dispense medicines, being accurate, balanced, fair, objective and complete.  That such promotion is done respecting the most stringent ethical principles of professionalism and responsibility. ESTABLISH  Establish a framework for the conduct of promotional activities by the industry, offering guidance and facilitating compliance by pharmaceutical companies of applicable rules. THE SPANISH CODE OF PRACTICE  GOALS

4. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL CODE COVERAGE THE SPANISH CODE OF PRACTICE  FARMAINDUSTRIA MEMBERS (ASSOCIATES) - NATIONAL COMPANIES: 98 (Large 10, Medium 6, Small 82) - INTERNATIONAL COMPANIES: 118 (Large 27, Medium 27, Small 64) Approximately 250 Pharmaceutical Companies representing the 98% total sales of prescription medicines in Spain  ADHERE COMPANIES (National & International) - Companies that voluntarily submit their promotion activities to the Code - Companies that are EFPIA members

5. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL ACTIVE MONITORING RESOLVES AND PUBLISHES SEEKS FOR CONCILIATION  THE CONTROL BODIES Code of Practice Surveillance Unit Code of Practice Committee Self-Regulation Jury THE SPANISH CODE OF PRACTICE

6. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL Prepares answers Control actions  THE CONTROL BODIES FARMAINDUSTRIA Board of Governors Pharmaceutical Companies Code of Pr. Surveillance Unit Code of Practice Committee Self-regulation Jury Appointment and reporting Surveillance Complaints Biding Querires Appoints the Director Other Stakeholders Inititate procedures Ask for clarification (queries) Resolves queires Seeks conciliation…if no agreement... Submits complaints (as party) Communicate possible infringements Communicate Events Info Supervises Communicate possible infringements Prepares Surveillance Plans and Reports every 3 months Annual Report Appoints Sets ruling, sanctions (if applicable) and publishes rulings Electronic Inf. 3rd parties events Submits complaints (as party) Control Bodies THE SPANISH CODE OF PRACTICE

7. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL 1MARKETING AUTHORIZATION 2INFORMATION TO BE MADE AVAILABLE 3INFORMATION AND ITS SUBSTANTIATION 4ACCEPTABILITY OF PROMOTION 5TRANSPARENCY OF PROMOTION 6USE OF REFERENCE QUOTATIONS 7DISTRIBUTION OF PROMOTIONAL MATERIAL 8PROMOTION VIA INTERNET 9SCIENTIFC SERVICE AND REVIEW OF PROMOTIONAL MATERIAL 10GIFTS AND INDUCEMENTS 11HOSPITALITY AND MEETINGS  ARTICLES  INTRODUCTION, PURPOSE AND SCOPE OF THE CODE THE SPANISH CODE OF PRACTICE

8. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL 12PHARMACEUTICAL COMPANY STAFF 13SAMPLES 14STUDIES 15RULES OF APPLICATION OF THE CODE 16REQUEST FOR QUERIES 17CONTROL OF THE BODIE COMPLIANCE 18INFRINGEMENTS AND SANCTIONS 19IMPLEMENTATION GUIDES AND COLLABORATION AGREEMENTS 20DISCLOSURE AND COMPLILATION OF DECISIONS 21DATE OF ENTRY INTO FORCE OF THE CODE THE SPANISH CODE OF PRACTICE  ARTICLES

9. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL HOSPITALITY AND MEETINGS CONGRESSES AND SCIENTIFIC EVENTS FUNDED BY THE INDUSTRY 88. 11.  The behaviour of the pharmaceutical companies must be guided by this principles:  Scientific goals must represent the main focus in the organization of such meetings  Hospitality should be reasonable at all times, and must always be secondary to the main purpose of the meeting A useful criterion Would the company like that all details of the organization of the event to be widely disseminated? THE SPANISH CODE OF PRACTICE

10. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL National and International Events THE SPANISH CODE OF PRACTICE  HOSPITALITY AND MEETINGS: HOTELS CRITERIA

11. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL THE SPANISH CODE OF PRACTICE GENERAL STANDARDS APPLICABLE IN SPAIN: EVENTS & HOSPITALITY

12. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL Located on Farmaindustria intranet there is a useful tool, available to all its members, through which the national and international events organized by third parties that have been reviewed by the Unit can be consulted.  EVENTS ORGANIZED BY THIRD PARTIES  System available to companies Compliance Officers only. THE SPANISH CODE OF PRACTICE

13. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL  EVENTS ORGANIZED BY THIRD PARTIES THE SPANISH CODE OF PRACTICE

14. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL  NON PERMITTED PARTICIPATION THE SPANISH CODE OF PRACTICE

15. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL  POSSIBLE PARTICIPATION WITH COMMENTS THE SPANISH CODE OF PRACTICE

16. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL  POSSIBLE PARTICIPATION THE SPANISH CODE OF PRACTICE

17. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL  ON STUDY BY THE SURVEILLANCE UNIT THE SPANISH CODE OF PRACTICE

18. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL Positive effects: When a national event is marked as non permitted: - Laboratories contact the organisers to let them know that there are some items that do not comply with the Code. - Organisers contact the Surveillance Unit for advise, make the correct changes for an approval qualification and send a signed letter certifying it. - Surveillance Unit changes the non permitted mark for the possible participation with comments marked and send an email to the laboratories to let them know the new conditions.  EVENTS ORGANIZED BY THIRD PARTIES THE SPANISH CODE OF PRACTICE

19. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL Procedure followed once an event which might; (i) cause an infringement of the Code of Practice or (ii) represents a material risk for pharmaceutical industry image; is identified:  Contact with the organizers (Scientific Society or Technical Secretary),  If necessary give a brief explanation of our self-regulation system (Article 11) and the role of the Surveillance Unit,  Indicate aspects related with the meeting that do not allow pharmaceutical industry collaboration. Explain why,  Propose solutions, alternatives, recommendations, modifications,  Inform companies about the result of this process and qualify the event.  CASE STUDY THE SPANISH CODE OF PRACTICE

20. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL GOLF TOURNAMENT DURING THE MEETING  CASE STUDY THE SPANISH CODE OF PRACTICE

21. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL  CASE STUDY Hereby confirm that the golf tournament has been cancelled and that no golf tournament will take place. The President of the Organization Committee. THE SPANISH CODE OF PRACTICE

22. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL  CASE STUDY THE SPANISH CODE OF PRACTICE

23. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL  CODE COMPLIANCE NETWORK (CCN) THE SPANISH CODE OF PRACTICE

24. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL  CODE COMPLIANCE NETWORK (CCN) THE SPANISH CODE OF PRACTICE

25. Spanish Code of Practice for the Promotion of Medicines CONFIDENTIAL CONCLUSIONS KEEPING AND REINFORCING THE CRITICAL ASPECTS, THE SELF-REGULATION SYSTEM IS A STRENGTH OF THE PHARMACEUTICAL INDUSTRY TO POSITIVELY IMPROVE ITS IMAGE BEFORE THE WHOLE SOCIETY (PUBLIC ADMINISTRATION, HEALTHCARE PROFESSIONALS AND PATIENTS)

26. THE SPANISH CODE SURVILLANCE UNIT Velázquez 109 E - 28006 Madrid - Spain Tel. +34 91 7452050 Fax +34 91 7450408 usd@codigo.farmaindustria.es www.farmaindustria.es