EBP Committee General Members Meeting Date : 20 th (Wed.) Oct., 2010 EBP Chair: Jannie Oosthuizen (Lilly)

Agenda I.Monthly Update of Committee Activity - Code Revision - Dual punishment system (Enforcement Regulation Revision) II. EBP Committee Award III.2011 EBP Committee Strategy IV.2011 EBP Committee Plan & Budget

I. Updates - Code Revision  Current Status - KRPIA and KPMA submitted revised Code to KFTC on 14 th Oct.  Next - KFTC will endorse it by Mid. November after confirming revision of Enforcement regulation of PAA, MSA, MDA. - New Code will be effective as of 28 th Nov., KRPIA will have Code explanation workshop inviting KFTC officials late November.  Workshop Discussion: Co-host with KPMA? - Working Guideline revision will be submitted to new CDC for approval in Dec

I. Updates - Code Revision  Online Reporting System - According to Code revision, online reporting system will be upgraded. - Timeline 1) System development by 10 th Nov. and open ß version to compliance managers for test 2) Comments collection by 19 th Nov. 3) Official launching on 25~26 th Nov.  Discussion - Is training needed? If needed, when?

I. Update – Enforcement regulation revision  Current Status - KRPIA submitted comments to MOHW on 8 th Nov. 1) Clarification required for observational study in clinic which does not have its own IRB. 2) Definition of consultation needs to be specified 3) PPM for nurses should be allowed. 4) Market research needs to be included as an exempted activity.  Next - MOHW will finalize revision of enforcement regulation before end of Oct. - The revised enforcement regulation will be effective as of 28 th Nov.

II. EBP Committee Award  KRPIA members’ night on 2 nd Dec.  Committee award for outstanding committee member - One person from each committee  Please recommend!

III EBP Strategy EBP Environment in 2011  Unified EBP code will be the industry standard in alignment with Execution Regulation of Medical Service Act. –Improve transparency and the decrease of illegal rebates. –However, the other part of the industry will develop covert ways of rebate provision Potential prevalence of back door kickback due to M-ATP Less concern of industry on EBP code by medium to small sized local companies  Dual punishment system for rebates effective on November 28, 2010  Government takes joint actions against illegal rebates –MOHW, Ministry of Justice, KFTC, National Tax Service, Prosecutor’s Office, National Police Agency and KFDA  KFTC 3 rd investigation report will be released in 2011

III EBP Strategy EBP Strategic Direction in 2011  Enforcement of new EBP code – Educate related personnel – Suggest the way of improvement of the code  Digitalize documents and training materials for broader access with protecting confidentiality – Any time, anywhere, and anybody – Not only member companies, but medical doctors and others  Develop environment for next generation EBP code – Consistent with global excellence – Improve transparency and objectivity in the market