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1 13ｦﾐ ﾌ08 ｦﾐ ﾌ6ｾ ﾒ26ﾑ80801O6ｾ4 47

2 13EFPIA ANNUAL MEETINGS ATHENS ﾑ806ｦﾐ6ﾑ801O096ﾑ803 ﾞ 096ﾑ806ｦﾐ6ﾑ801O096ﾑ803 ﾞ O06 罍ﾞ03036ﾒ2ｦﾐ ﾒ ﾇ 6ﾑ809ｦﾐ6ﾒ206O09 ﾇ EFPIA ANNUAL MEETINGS ﾑ806ｦﾐ ﾇ096ﾒ2ｦﾐ ﾒ70 ﾞ03 ﾞ02O0609 6ﾒ ｾ40803 ﾞ036ﾒ2706ｾ46ﾑ O08 03 罔ﾐ03 ﾞ03 6ｾ46ﾒ2 ﾞ 09 ﾞ076ｾ4ｦﾐ ﾞ 6ﾒ ﾑ86ﾒ2 ﾇ6ｾ ｾ40803 ﾞ036ﾒ2706ｾ46ﾑ ﾒ2 ﾇ0ｹ0 EFPIA 6ｾ46ﾒ2 ﾇ03 ﾞ ﾞ (EFPIA ANNUAL MEETINGS) ﾞ036ﾒ2 ﾞ 縺0303ｦﾐ6ｾ46ﾒ2ｦﾐ ﾒO6ﾒ2 ﾇ6ﾒ2 ﾞ: ﾇ 6ﾑ ﾞ07 ﾒ ﾇ 02 ﾞ0609 ﾞ ﾒO08ｦﾐO09 ﾇ01 ﾞ03ｦﾐ ﾞ ﾒｦﾐ ﾑ8086ﾑ8ｦﾐ ﾞ03 ﾞ056ﾑ80306 ﾇ6ｾ4 ﾇ 6ﾒ2 ﾇ6ｾ4 02 ﾞ0609 ﾞ ﾒ6ﾑ8086ﾒ2ｦﾐ ﾒ ﾇ6ｾ4 03O09O056ﾑ86ｾ4ｦﾐ ﾞ6ｾ ｾ O08 ｦﾐO 0809O0806 縺 縺6ﾑ8ｦﾐ ﾞ6ｾ4 2 ｦﾐO0803ｦﾐO O0907 ｦﾐ6ﾑ80ｹ0 09O08 03 罔ﾐ03 ﾞ03 6ｾ46ﾒ2 ﾞ 09 ﾞ076ｾ4ｦﾐ ﾞ 6ﾒ2O08 6ｾ408036ﾑ O08 ｱ ﾇ 6ﾑ ﾇ 6ﾒ2 ﾇ6ｾ4 08 縺6ﾑ8ｦﾐ ﾞ6ｾ4: 036ﾑ86ﾑ86ｾ4 6ﾑ8 6ﾑ808056ﾑ806ｦﾐ6ﾑ86ｾ4 罔ﾐ ﾞ 6ﾒ2O086ｾ4 ﾞ6ｾ4056ﾑ8036ﾑ8ｦﾐ6ｾ4 ｱ 01 ﾞｦﾐ066ﾑ86ﾒ2ｦﾐ6ｾ409O0ｹ0 6ﾒ2O08 6ﾑ809ｦﾐ6ﾒ20709O O030406O08 6ﾒ2O08 6ｾ4026ﾑ86ﾑ8. ﾒ06 ﾞ6ｾ40906 ﾇ ｦﾐ6ﾑ ｾ4 ﾇ 6ﾒ2 ﾇ6ｾ4 6ﾑ ﾞ07 ﾒ ﾇ6ｾ4 6ﾑ803036ｾ4 ﾇ6ｾ4 ﾒ ﾞｦﾐ 08 縺6ﾑ8ｦﾐ ﾞ O09ｦﾐ 07 ﾞ 6ﾒ2O O0806 絨6ｨ8 08 縺6ﾑ807 ﾞ0ｹ0 ﾒ ﾞ05 ﾇ 罍ﾇ6ﾒ2O6ｨ8 ﾒ. 6ｾ46ﾒ26ﾑ802 ﾞ ﾇ 6ﾑ803ｦﾐ ﾞｦﾐ ﾞ 6ﾑ ﾞ07 ﾒ ﾇ ﾞ 絨06 ﾞ 6ｾ46ﾑ8 6ｾ4016ﾑ86ｾ4 ﾇ 096ﾑ8 6ﾒ2ｦﾐ6ｾ4 09 ﾞ06O016ﾑ86ｾ4 08 縺6ﾑ8ｦﾐ ﾞ6ｾ4 ﾒ ﾞｦﾐ 6ﾒ2 ﾇ03 ﾒOｦﾐ030303ｦﾐ ﾒ ﾇ ﾞ6ｾ402 ﾞ ｦﾐ6ｾ4 ﾇ O09ｦﾐ 07 ﾞ 6ﾒ2 ﾇ0ｹ0 6ﾑ809ｦﾐ6ﾒ206O09O08 ﾞ. 04ｦﾐ ﾞ09 ﾞ036ﾒ2O09O6ｨ8 O ｾ ﾞ ﾆO036ﾒ2 ﾞ6ｾ ﾑ8 6ﾑ8ｦﾐ ﾞ 罔ﾐ ﾞ 6ﾒ2O086ｾ4 ﾞ6ｾ4056ﾑ8036ﾑ8ｦﾐ6ｾ4 ﾒ ﾞｦﾐ Oｦﾐ ﾒO03O09ｦﾐ ﾒ ﾇ 6ﾑ ｾ46ﾒ2ｦﾐ ﾞ 罔ﾐ ﾞ 6ﾒ2 ﾇ03 6ﾑ ﾇ O09ｦﾐ 07 ﾞ 6ﾒ2O O030406O08 6ﾒ2 ﾇ0ｹ0 EFPIA SIR TOM MCKILLOP G-10 O09 ﾞ04 ﾞ 0803 ﾇ O08 6ﾑ809ｦﾐ096ﾑ804O08 罔ﾐ ﾞ 6ﾒ2 ﾇ03 ﾒ ﾞｦﾐ03O6ﾒ2O09ｦﾐ ﾞ ﾒ ﾞｦﾐ 6ﾒ2 ﾞ 02 ﾞ0609 ﾞ ﾒ ﾞ O09ｦﾐ 07 ﾞ 6ﾒ2O08 6ﾑ809ｦﾐ6ﾒ206O09O08 E. LIIKANEN ﾞ03ｦﾐ6ｾ4O6ﾒ2 ﾇ6ﾒ26ﾑ86ｾ4 6ｾ46ﾒ2 ﾇ O6ｾ408 ﾞ6ｾ4 ﾇ 6ﾒ ﾑ ﾞｦﾐ0303 ﾞ6ｾ4056ﾑ ｾ46ﾒ2 ﾞ 036ﾑ8 ﾞ 02 ﾞ0609 ﾞ ﾒ ﾞ O09ｦﾐ 07 ﾞ 6ﾒ2O08 ﾞ036ﾒ2ｦﾐ0906O030406O08 6ﾒ2 ﾇ0ｹ0 EFPIA J. FRANCOIS DEHECQ ﾞ0609 ﾞ ﾒ ﾞ 罔ﾐ ﾞ 6ﾒ2 ﾇ03 ﾞ O6ﾒ2 ﾇ6ﾒ2 ﾞ ｰMEDICINES FOR MANKIND ｱ ﾒ ﾞ 086ﾒ26ﾑ806 ﾞ 02 ﾞ0609 ﾞ ﾒ ﾞ 罔ﾐ ﾞ 6ﾒ2 ﾞ 09 ﾞｦﾐ04ｦﾐ ﾞ ﾒ2 ﾞ ﾒ ﾞｦﾐ03O6ﾒ2O09 ﾞ 02 ﾞ0609 ﾞ ﾒ ﾞ 0909O06O ﾞ 086ﾑ8 6ﾒ2ｦﾐ036ｾ4O0803 6ｾ4 ﾇ09 ﾞ036ﾒ2ｦﾐ ﾒ ﾞ 6ﾒ2 ﾇ03 ｦﾐ ﾞ6ﾒ206O02 ﾞ0609 ﾞ ﾒ6ﾑ8086ﾒ2ｦﾐ ﾒ ﾇ 096ﾑ806ｦﾐ05 ﾞ 03 ﾇ 6ｾ46ﾒ2ｦﾐ6ｾ4 0809O 6ﾑ8036ﾒ2 ﾞ6ｦ1 ﾇ ﾑ86ｾ ﾇ ﾞ ﾞ09O 6ﾒ2O 縺6ﾑ803ｦﾐ ﾒO 04/036ﾒ2 ﾇ 6ﾒ2 ﾇ6ｾ4 EFPIA BRIAN AGER ﾞ04ｦﾐ ﾞ 6ｾ4026ﾑ86ﾑ8 ｰNYXTE6ｾ4 ﾞｦﾐ 罍ﾞｦﾐO08 096ﾑ8 ﾞ 絨086ｾ4 ｱ ORGANIZING COMMITTEE p.3 ENGLISH ADDENDUM EFPIA ANNUAL MEETINGS ATHENS PRESS RELEASES p.37 6ｾ400 0ｸ702fi ｦ004080ｹ0 040ｸ : 6ｾ ｸ7036ｦ ｾ46ｦ ｹ (ROCHE) 08apple006ｦ0030ｸ ｨ803090ｹ0 & 0903o o6ｦ0. 08o ｨB6ｧ80ｹ0 (GlaxoSmithKline) 09 閨03080ｹ o (Pfizer) 09 閨03080ｹ0 ﾒ. 09 apple 030ｷ30007 (Janssen- Cilag) 09 閨03080ｹ0 ﾆ0ｷ36ｧ ｾ ｧ9 2 6ｾ4f6ﾑ86ﾑ ｦ004o0ｹ 閨02o0ｸ o ｷ ｷ307 0ｸ7apple o0ｸ7 6ｾ4026ﾑ86ﾑ ｸ702fi030ｸ apple0602o06070ｷ3076ｧ9 0ｹ0 020ｷ ｹ o6ｦ004090ｹ0 縺 fi0ｹ ｸ7030ｸ707026ｧ80ｹ0 6ｾ ｸ7036ｦ ﾑ8apple o ｷ ｸ704o04apple ｹ0 03o000602fi0ｹ0 6ｾ46ｦ0006 5o0ｸ703o0ｹ0 ﾆ ﾑ8apple0602o06070ｷ3076ｧ9 & fi ｹ0 6ｾ404 閨 ｹ0 6ﾑ8. 6ｾ4apple 閨0902 6ﾑ ｧ8 縺 ｧ9 ﾞ. 09o036ｧ90209 縺 ｧ9 縺 ﾒ fi07020ｷ307 6ﾑ8. 縺 O0602o07o 閨 o ｧ80306o 04. ﾞ030001fi0903o0ｸ7 6ﾒ ｧ8 08appleo04026ｧ

3 13EFPIA Annual Meetings ﾌ ｷ ｧ8 6ﾑ8apple apple6ｧ8/Organizing committee ﾌ ｷ ｧ8 6ﾑ8apple apple6ｧ8/Organizing Committee co-chair 09 M. C. Pickaert ﾞ07 apple 縺 ｧ8 04/ EFPIA (6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ8 O00o04appleo07 6ｧ ｸ ﾑ8apple ｧ804000ｷ ｾ40ｸ707 閨04000ｷ307) 09. ﾒ ｹ0 6ﾑ8apple6ｧ o0ｹ0 0903fi00 03o0ｹ0 6ｾ4026ﾑ86ﾑ8 (6ｾ46ｦ o0ｹ ｸ ﾑ8apple ｧ804000ｷ307 6ﾑ o0ｹ0) Members Members: 09 B. Kressmann LEEM 09 A. Moroni FARMINDUSTRIA 09 J- M Muschart AGIM 09 M. Mees ASTRAZENECA 09 A. Nolan IPHA 09 I. Sanz De Madrid FARMAINDUSTRIA o6ｦ004090ｹ0 6ｾ402EE 09 6ｾ ｾ402EE 09 A. Walter EFPIA 09 ﾆ ｾ402EE ( 罍 fi0ｹ0 6ｾ46ｦ o0ｹ0) (ｦﾐ fi0ｹ0 6ｾ46ｦ o0ｹ0) ( fi0ｹ0 6ｾ46ｦ o0ｹ0) (ｦﾐ fi0ｹ0 6ｾ46ｦ o0ｹ0) (ｦﾐ04apple fi0ｹ0 6ｾ46ｦ o0ｹ0) 02006ｦ004o0ｹ0 47 6ｾ4f6ﾑ86ﾑ8 3

4 13EFPIA ANNUAL MEETINGS ATHENS 2003 EFPIA ANNUAL MEETINGS ATHENS 2003 ﾌ0903fi ｹ ｹ0 EFRIA Sir Tom McKilloop ﾇ ｹ0 000ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｸ ｧ80ｹ o ｧ9 0ｹ ｸ7appleo6ｦ ｹ0 00 閨03000ｹ ﾑ , ｹ0 applefi 26 閨0ｷ30ｹ ｹ1o0ｸ ｸ ｧ ｹ0 6ﾑ ｧ80ｹ0 0903o00 036ｧ9 0ｹ ｹ0 6ﾑ ｷ304090ｹ0 apple oappleo066ｧ apple o ｹ0 09 apple06o ｧ ｧ8030ｷ o0ｸ7 000ｸ7030ｷ3apple 0ｸ802o6ｦ ｸ o6ｦ o0ｸ7: ｧ80406 縺 ｧ8 6ｾ40ｸ707 閨03000ｸ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ0 O00o04appleo07 6ｧ9 0ｹ0 6ｾ40ｸ707 閨04000ｷ ｸ ﾑ8apple ｧ804000ｷ307 (EFPIA), 09 oappleo6ｧ o fi020003o apple03fi ｷ ｷ307 00EFPIA Annual Meetings appleo0ｸ7 06o ｸ ｧ o07 6ｾ46ｦ o ｸ ﾑ8apple ｧ804000ｷ307 6ﾑ o0ｹ0 (6ｾ4.02.6ﾑ8.6ﾑ8.). 6ｾ40ｸ ｧ ｸ7036ｧ90ｷ30ｹ0 0903fi00 03o06, 縺 o6ｧ ｸ7030ｸ70702 閨0ｹ 閨 ｷ ｦ ｷ ｸ apple ｧ804000ｷ ｸ707 閨04000ｷ ｹ0 6ﾑ80ｸ70306apple090ｹ0. 6ﾑ8apple06apple03 鑰07 apple 閨 o o0ｸ70309o6ｧ9 02o0ｸ7 0900o046ｧ9o0ｸ7 02o00 陦, (02fi04o fi fi04o apple6ｧ9apple00 o 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｷ304090ｹ0) ｸ802o6ｧ9, 0002apple03fi040ｷ3appleo06 040ｸ70303fi- 090ｷ ｹ ｸ ｹ0 02o0ｸ o6ｦ00ｹ0 026ｦ0appleo0ｸ applefi 02060ｹ fi ｹ ｹ0 6ｧ o 6ｾ40ｸ o 閨00 00 ﾇ 6ﾑ80ｸ70306apple ｹ ｧ9 0ｹ0: 03 閨000ｹ0 6ﾑ803000ｸ ｧ9000ｹ o0ｸ70ｹ0 ﾞ ｧ90ｹ0 02o0ｸ7 6ｾ46ｧ (The Europe of Health ｨC New Freedoms for Today ｯs Patients). ﾇ 閨 ｹ ｧ8030ｷ304090ｹ0 閨 applefi 02o07 08appleo0ｸ70309fi ｧ9 0ｹ0 K ｧ8 ﾒ. 6ｾ ｧ8. 6ｾ402oapplefi0ｹ0 02o0ｸ7 6ｾ40ｸ ｧ9o0ｸ7 6ｧ ｸ ｷ ｸ appleo0ｸ7 0000appleo 6ｧ9ｨBo0ｸ apple03fi ｷ 閨000ｹ apple006ｧ9000ｹ0. 6ｾ40ｸ ｧ ｦ ｷ307 o 0903fi00 03o0ｹ0 02o0ｸ7 6ｾ4026ﾑ86ﾑ8 02. 縺 o0ｹ0 6ｾ40ｸ ｹ o 00apple6ｧ o0ｹ0 0903fi00 03o0ｹ ｷ3076ｧ9 0ｹ0 ﾒ ｹ0. ﾌ0903fi ｹ ｸ7 6ｾ4026ﾑ86ﾑ ｾ40ｸ ｹ oappleo066ｧ ｸ ｷ307 Heads of Regulatory Agencies, ｧ8 020ｷ307 00apple ｧ80ｹ0 020ｷ fi 060ｷ ｷ307 ﾒ ｹ0 6ﾑ ｷ304090ｹ 閨 ｷ EFPIA. 6ﾒ2090ｹ0 040ｸ ｧ804000ｷ30ｹ0 apple03o 陦03000ｸ70400 o 0903fi00 03o0ｹ0 02o0ｸ7 6ﾑ8O02 ﾒ ｧ80ｹ appleo0ｹ0 6ｾ ｹ0. 4 6ｾ4f6ﾑ86ﾑ ｦ004o0ｹ0 47

5 ﾞ ｷ3applefi ﾇ 閨03000ｸ ｧ , apple006ｧ9 6ｦ00306o03 6ｧ o 03 閨 ｹ0 閨 ｹ0 appleo0ｸ7 06o o03006ｧ apple 閨020006o applefi ｧ9 030ｸ ｹ0 EFPIA, oappleo6ｧ9 apple03o6 5036ｧ apple ｦ ｹ ｸ ｧ80ｹ0 閨03000ｸ707 0ｹ apple006ｧ o06 000ｸ ｧ9000ｹ apple ｷ3 0707apple020ｸ ｹ0 閨03000ｸ707 0ｹ0. 6ﾑ8apple6ｧ904090ｹ0 06o ｦ0o workshops 閨00 : apple ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ ｷ apple oapplefi o03o096ｧ o 07o00o fi appleo0ｸ ｦ o 00 閨0303o ｹ ｧ ｹ0 apple ｷ appleo02036ｧ907o ｹ ｹ fi04o 02o 0ｸ707 02fi ｦ apple ﾑ 閨03o0ｸ70ｹ ｹ o6 506o ｧ9 0ｹ ｦ007090ｹ0, o Dr Daniel Vasmant, 0903fi00 03o0ｹ ｹ ｧ80ｹ0 o0007 0ｹ ｧ9 0ｹ ｹ0 EFPIA apple , 02fi fi ｧ apple ｧ ﾒo0607fi 閨0203 apple03o 閨07o0ｸ7: ｦ 閨03000ｸ apple020ｸ apple ｷ apple006ｧ9 apple fi040ｷ ｧ ｧ ｸ 閨 ｸ7006 5o036ｧ ｹ0 6ﾑ80ｸ70306apple090ｹ0 0402o apple 0902fi040006o 096ｧ apple020ｸ ｦ ｷ307 apple ｷ ﾇ apple 03o046ｧ8 0ｸ709006ｧ9 0ｹ ﾑ80ｸ70306apple09 02o 閨 ｦ0030ｸ ｹ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｷ304090ｹ0. 6ﾒ2 閨03o0ｹ0 閨 ｸ ｧ ｹ0 6ｦ0o ｸ700 閨070ｷ307 o0007 0ｷ ｹ0 EFPIA o06 oappleo6ｧ9000ｹ0 0404o03o6ｦ ｧ90306 ｨB09026ｧ appleo0ｸ7 08o03o6ｦ fi0306 (EVM European Vaccine Manufacturers) 閨 o o03o096ｧ9 0ｹ0 (EBE Emerging Biopharmaceutical Enterprises). 6ｾ402 apple03 6ｧ o0ｸ7 6ｾ40ｸ ｧ9o0ｸ7 06o ｸ707 閨 ｸ7016ｧ8 026ｦ0appleo0ｸ oappleo6ｧ9 040ｸ ｧ o Sir Tom McKillop, 0903fi00 03o0ｹ ｹ0 EFPIA, o ﾞ070206apple03fi00 03o0ｹ ｹ0 EFPIA 02. Jean-Francois Dehecq, o 02. 縺 o0ｹ0 6ｾ40ｸ ｹ0, 0903fi00 03o0ｹ0 02o0ｸ7 6ｾ4026ﾑ86ﾑ o 02. Brian Ager, 縺 fi0ｹ ｸ7030ｸ707026ｧ80ｹ ｹ0 EFPIA. 00 ﾇ 6ﾑ80ｸ70306apple09 apple03 鐶pple ｦ apple fi020003o o02o006ｧ9, apple03o0ｹ0 fi080003o0ｹ0 020ｷ ｧ8030ｷ30400 o sir Tom McKillop. O 0903fi00 03o0ｹ ｹ0 EFPIA 閨 fiapple ｷ ｷ307 appleo0ｸ7 appleo020003o6ｦ007 apple03o fi ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ ｸ ｧ8 0806o ｧ9. 6ﾒ2fi apple ｸ ｧ ｷ304026ｧ8 0604o0303oapple6ｧ ｦ0 appleo ｧ80ｹ0 0ｸ709006ｧ9 0ｹ0, 02o06070ｷ ｧ80ｹ0 appleo ｧ80ｹ ｸ ｧ80ｹ0 appleo ｧ80ｹ0: 00O ｧ90ｹ ﾑ80ｸ70306apple09 046ｧ apple03o04 o02o6ｦ ｸ ｹ0 0700fi ｦ , appleo0ｸ o0ｸ70ｹ0 6 5o09036ｧ804o0ｸ ｨB6ｧ804o0ｸ707 apple fi o, 07 appleo02026ｧ804o0ｸ ｦ apple ｷ fi 閨04o0ｸ ｦ appleo06fi ｨB0ｷ36ｧ80ｹ 閨040ｷ ｹ ｧ80ｹ0 閨03000ｸ707 0ｹ0, appleo0ｸ ｸ ｧ8 0806o ｧ9 apple03o0408 閨03o ｹ0 000ｸ ｧ9000ｹ apple0603o09 閨0ｹ0 0402o0ｸ70ｹ ｧ90ｹ apple00036ｧ ｸ ｧ80ｹ0 appleo06fi ｹ ｧ8 0ｸ709006ｧ9. 00apple0ｷ30ｹ ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ8 6ﾑ8apple060203oapple6ｧ8 02o 1994, 02o 00 閨0303o ｹ ｸ ｧ80ｹ0 閨03000ｸ707 0ｹ ﾑ80ｸ70306apple apple03 鐶pple ｧ ｧ907 0ｸ707o applefi 02o fi000007o 閨03o07 020ｷ o 6ｧ90ｷ apple000306o fi 020ｷ307 apple ｸ709006ｧ9 0ｹ ｷ307 oappleo6ｧ90ｷ307 0ｷ30ｹ ｷ30402fi appleo020003o6ｦ fi 00fi07o appleo04o0402fi. 6ﾒ2 040ｸ704026ｧ ｸ o07o ｧ80ｹ0 apple00036ｧ ｹ 閨04o0ｸ ｧ9appleo ｧ904o0ｸ707 applefi 閨 ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｸ ｧ80ｹ0 0806o ｧ9 0ｹ ｸ707090ｹ0. ﾇ ｸ ｧ8 0806o ｧ9 appleo ｧ9 閨07 07 applefi 02o0ｸ70ｹ o6ｦ00ｹ0 040ｸ 閨0ｹ ｹ0 o0602o07o006ｧ9 0ｹ ｹ0 6ﾑ80ｸ70306apple090ｹ0, 02090ｹ0 00apple o ｧ80ｹ ｧ80ｹ0 apple03ofi o0ｸ7, apple06020ｸ7046ｧ ｹ0 006ｧ o ｧ80ｹ ｧ9 0ｹ ｸ ｸ709006ｧ9 020ｷ307 appleo ｹ0 6ﾑ80ｸ70306apple090ｹ ｦ004o0ｹ0 47 6ｾ4f6ﾑ86ﾑ8 5

6 13EFPIA ANNUAL MEETINGS ATHENS 2003 ﾞ ｷ fi : ﾞ ｷ fi : ﾇ 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ o6 506o ｧ ｸ707006ｦ00006 ﾇ 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ o6 506o ｧ ｸ707006ｦ ﾒ2 0402o ｧ9 02o0ｸ7 2002, 00apple o0ｸ707 fi ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ ｸ ｧ8 0806o ｧ9 006ｧ 閨07 0ｹ0 applefi 02o0ｸ70ｹ o6ｦ00ｹ0 02o00006ｧ90ｹ0 0ｸ ｧ80ｹ o03o096ｧ9 0ｹ ｹ0 6ﾑ80ｸ70306apple090ｹ ｸ 閨0ｹ0 00apple06 fi ｹ0 fi04o07 08o apple 0404fi ( ｸ700 閨07o0ｸ70ｹ0 0ｸ7apple 03036ｧ803o0ｸ70ｹ0), apple ｷ fi ( 016ｧ9 0ｹ o00000ｸ7036ｧ90ｷ307 6ﾑ80ｸ70306, o 閨0ｹ 閨0ｹ0), ｸ707 & ﾞ0707apple020ｸ70109 (00apple0007 6ｦ , o00006ｦ ﾑ80ｸ70306) o apple0300fi o0ｸ7 0000appleo030602o6ｦ0 0604oｨB0ｸ7096ｧ9o0ｸ7 ( fi 0604oｨB6ｦ0-0906o o00000ｸ7036ｧ90ｷ307 6ﾑ80ｸ70306) fi04o, applefi o ｧ9 apple03o026ｦ0apple fi ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ ｸ ｧ8 0806o ｧ9 006ｧ ｸ707030ｷ ｷ fi ｹ ｧ ｸ ｹ 閨 ﾞ ｧ ｸ ｧ8 0806o ｧ9, 09 oappleo6ｧ9 閨 ｸ7016ｧ ｸ ｧ ｹ0 appleo ｹ0 applefi03o 閨 ｹ ｸ707 & ﾞ0707apple020ｸ o02fi000ｷ ｷ307. ﾇ 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ ｸ ｧ8 0806o ｧ9, appleo0ｸ7 00apple6ｧ ｧ apple030ｷ302oapplefi03o0ｹ apple 0902fi040006o 00apple6ｧ9apple00 o 閨03000ｸ o02fi000ｷ ｷ307, 03fi090ｷ3 o0602o07o apple06 閨04000ｷ307 閨 ｧ ｹ0 00apple0007 6ｦ ｹ ｸ707 & ﾞ0707apple020ｸ 閨0ｷ ｷ307. O06 020ｸ70306fi o06 03fi09o ｸ ｧ8 6ｦ o0ｸ7 02fi0402o0ｸ70ｹ ｸ707 0ｹ0 & ﾞ0707apple020ｸ701090ｹ0 閨07o0ｹ0 07 鑰0ｸ o0ｸ7 o08006ｧ903o o o07fi0ｹ0 fi fi07o 閨07 07 鑰 o apple03o026ｦ0apple applefi ｸ o0ｸ , 0402o 0ｸ fi 02fi0402o0ｹ ｷ3096ｧ o o 0403o070602fi appleo0ｸ7 apple ｧ 閨 ｷ ｷ307 applefi 02060ｹ0 0300fi 06000ｹ 閨0ｹ0. 05 appleo020003o6ｦ ｸ7apple0003 apple03o6ｦ ｸ appleo 0604o0ｸ ｧ90ｷ ｹ ｷ fi ｹ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｸ ｧ80ｹ0 0806o ｧ9 0ｹ 閨 fi07o apple o0702. ﾇ 6ﾑ80ｸ70306apple09 apple03o ｦ ｸ707o fi ｹ0 00apple0007 6ｦ ｹ ｸ707 & ﾞ0707apple020ｸ 閨 ｹ0 ﾇ09 ﾞ. 6ｾ4 ｯ 0ｸ702fi 040ｸ o0ｸ707 o06 o0602o07o 閨0ｹ0 040ｸ707036ｧ802000ｹ o06 040ｸ707036ｧ802000ｹ apple0007 6ｦ ｹ0, 02o apple o07 apple 03o046ｧ80ｹ0 0ｸ7apple ｸ709006ｧ9 0ｹ0, o ｧ9000ｹ0 閨 ｹ fi o06 02o06070ｷ 閨0ｹ ｧ ｹ ｹ0 07 閨000ｹ o03o096ｧ9000ｹ0. 00O ｧ90ｹ ｹ0 ﾇ09 ﾞ 006ｧ apple03fi030ｸ700o ｧ901o0ｸ o02o006ｧ9 ｨC03 閨03o0ｸ o appleo o0ｸ apple0300o ｧ ｷ 閨0ｷ apple o076ｧ9ｨB0006 o Sir Tom McKillop. 00O ｧ90ｹ ﾑ80ｸ70306apple09 03 閨03o0ｸ 閨04o0ｸ ｧ8 02o0ｸ70ｹ0 apple fi ｹ0 apple030903o08o036ｧ9000ｹ ｹ apple000ｸ 閨0ｹ0 090ｷ309 閨0ｹ0. 05 閨03o0ｸ707 00apple6ｧ904090ｹ0 07 閨04o0ｸ ｦ ｸ o046ｧ8 0402o fi 02090ｹ0 appleo ｧ80ｹ0 0ｸ709006ｧ9 0ｹ fi03 0ｸ ﾑ80ｸ70306apple ｨB ｸ706o ｧ 閨000ｹ o03o096ｧ9000ｹ ｧ fi0009 閨02o ｷ3apple6ｧ ｹ 閨04o0ｸ704000ｹ o 閨0ｹ ｹ0 apple00036ｧ ｹ0 02o0ｸ o0702o0ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ802o6ｦ0 apple ｸ70400o6ｦ ｾ4f6ﾑ86ﾑ ｦ004o0ｹ0 47

7 13 ﾞ ｹ ｸ ｧ80ｹ0 03o00o ｧ9 0ｹ0: 09 EFPIA ｧ9 02 ﾒ 閨 o ｧ804o0ｸ707 閨 o fiapple03 6ｧ90406o apple 0902fi040006o0ｸ7 00apple06apple 陦o0ｸ o02fi applefi 02o 6ｾ40ｸ7006 5o6ｦ00306o 08appleo0ｸ ｧ9 0ｹ ｹ0 6ﾑ8.6ﾑ8. 09 EFPIA, 0402 apple03 6ｧ ｹ0 縺 ｧ80ｹ ｹ0 6ｾ40ｸ707 閨03000ｸ704090ｹ0, o ｷ30400 workshop 閨 ﾞ ｹ ｸ ｧ80ｹ0 03o00o ｧ9 0ｹ0. 00apple0ｷ30ｹ0 02o076ｧ , o06 026ｦ ｹ0 apple03o fi ｹ EFPIA 006ｧ907 06: 09 ﾇ apple03o ｧ9 020ｷ o00 閨070ｷ307: 09 O ｧ9000ｹ0 閨 ｹ0: 09 ﾇ 000ｸ ｧ9 020ｷ307 00apple ｧ804000ｷ307: 09 ﾇ o00apple 09036ｦ0apple : 09 EFPIA 0ｸ7appleo ｧ9ｨB fi0706 apple03o ｧ9 0ｹ0 020ｷ o00 閨070ｷ307. ﾞ0ｸ702fi 03 appleo 閨 ｧ9 o0ｸ ｧ8 6ｦ appleo0ｸ7 03 o 09096ｧ 閨03000ｸ ﾑ80ｸ70306apple EFPIA 0ｸ7appleo ｧ9ｨB ｹ0 appleo0ｸ ｧ904o0ｸ707 閨07 0ｸ707 02fi appleo fi 6ﾑ8096ﾑ8 ﾞ/ ﾒ ｧ ｧ9, ｸ707 0ｸ7 0400fi ｹ0 appleo0ｸ ｸ702o036ｦ007o0ｸ ｹ0 00apple 閨0ｹ fi ｹ0. 09 EFPIA 0ｸ7appleo ｧ9ｨB o00o ｧ9 appleo0ｸ ｸ702o036ｦ ｹ0 00apple 閨0ｹ fi ｹ0. 09 EFPIA 0ｸ7appleo ｧ9ｨB0006 閨0702o ｸ ｷ ｹ0 02o0ｸ7 040ｸ704026ｧ800 02o0ｹ o00apple 09036ｦ0apple ｹ0. 09 ﾇ apple03o 閨 apple000ｸ ｧ8 016ｧ9 : 09 EFPIA apple ｦ00006 fi ｷ3096ｧ8 02o0ｸ7 fi03o0ｸ7 0ｷ30ｹ ｧ9o0ｸ 閨 fi0ｹ0 apple03o0ｸ8fi0702o0ｹ ｧ 閨0ｹ0 040ｸ707 鐶pple ｹ fi0406 0ｸ709006ｧ9. 09 O06 apple030903o08o036ｧ9000ｹ0 apple03o0ｹ0 02o ｧ8: 09 EFPIA ｷ304o036ｧ9ｨB ｧ appleo0ｸ apple 閨6 7o0ｸ o0ｸ70ｹ ｧ90ｹ o0ｸ70ｹ ｷ302 閨0ｹ apple03fi apple030903o08o036ｧ9000ｹ ｾ40ｸ7006 5o6ｦ00306o 08appleo0ｸ ｧ9 0ｹ0 2 ｦﾐo0ｸ7076ｧ9o0ｸ ﾒ ｦ ｷ307 08appleo0ｸ ｧ9 0ｹ ｹ0 6ﾑ8.6ﾑ oappleo6ｧ9 040ｸ ｧ o06 08appleo0ｸ70309o6ｧ9 020ｷ307 0ｸ7applefi 閨 ｷ , ｹ0 2 ｦﾐo0ｸ7076ｧ9o0ｸ o o0ｸ o6ｦ00309o 00apple ｦ appleo ｧ8 040ｸ700080ｷ3076ｧ apple6ｧ9 020ｷ307 07o00o 閨070ｷ307 02o0ｸ7 00 ﾒ 07o o6ｦ ｹ0 00O 09096ｧ9 0ｹ apple ｧ ｾ402060ｹ0 25 ｦﾐ080ｸ7076ｧ9080ｸ7 09 6ﾑ ｧ ｧ ｧ8030ｷ ｰapple ｧ8 040ｸ700080ｷ3076ｧ9 ｱ ｧ ﾒ O 00apple6ｧ90203oappleo0ｹ0 02. Erkii Liikanen o06 08appleo0ｸ70309o6ｧ ｧ9 0ｹ0 fi030ｷ ｷ ｷ ｸ ﾑ ｧ8 0903o00 036ｧ o07 apple03o ｦ0o appleo0ｸ70309fi 02. ﾒ ｾ ｧ apple03o04apple appleo0ｸ ｧ fi apple6ｧ9apple00 020ｷ oapplefi o0ｸ703096ｧ ｹ0 o03o ｷ300 閨07090ｹ0 apple03fi ｹ0 appleo0ｸ 閨 appleo ｧ8 040ｸ700080ｷ3076ｧ9. ﾇ apple03o00 036ｧ ｹ0 o0007 0ｹ ｧ9 0ｹ0 02o0ｸ7 6ｾ40ｸ7006 5o0ｸ7036ｧ9o0ｸ7 閨 applefi ｸ7036ｦ o046ｧ90ｷ307 6ｾ404 閨04000ｷ307 02o0ｸ7 6ﾑ8O ﾒ ｧ ｷ303 0ｹ ｦ004o0ｹ0 47 6ｾ4f6ﾑ86ﾑ8 7

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9 136ｾ40ｸ707 陦 ｰ ﾇ 6ﾑ80ｸ70306apple ｹ ｾ40ｸ707 陦 ｰ ﾇ 6ﾑ80ｸ70306apple ｹ ｧ9 0ｹ0: 03 閨000ｹ0 6ﾑ803000ｸ ｧ9000ｹ ｸ70ｹ ｧ90ｹ ｸ7 046ｧ ｱ 03 閨000ｹ0 6ﾑ803000ｸ ｧ9000ｹ ｸ70ｹ ｧ90ｹ ｸ7 046ｧ ｱ fi0ｹ ｸ7 6ﾑ8apple06026ｧ900080ｸ 陦03080ｸ ｸ7 6ｾ4026ﾑ86ﾑ ﾒ ﾑ86ｧ apple ｧ8 07 apple000ｸ7036ｦ007o o0ｸ70ｹ0 02o030ｸ708 6ｧ9o0ｸ70ｹ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ o6 506o ｧ9 0ｹ0. 6ﾑ 閨03o0ｸ70ｹ0 02o0ｸ7 04.6ｾ ｷ o0ｸ7 6ｾ4026ﾑ86ﾑ8 04 0ｹ ｷ304o036ｧ9ｨB0ｷ ｹ ｹ0 006ｦ004o ｧ o076ｧ8. 6ﾑ86ｧ ｸ7020ｸ704006ｧ90ｹ ｸ7apple00036ｧ808 07o06 appleo0ｸ o010007o6ｦ ｹ ｧ80406 縺 ｧ8 6ｾ40ｸ707 閨03000ｸ ｸ ｧ ｹ0 EFPIA, 02090ｹ0 040ｸ707o00o04appleo07 6ｧ9 0ｹ0 00 0ｹ0 appleo0ｸ7 040ｸ700apple 閨02o0ｹ fi0706 applefi 02090ｹ o0ｸ703096ｧ ｹ ｧ 閨6 5 06o06 fi0206 o06 040ｸ7ｨB09026ｧ ｹ ｧ8 applefi6 7000ｷ ｷ ｸ ｷ o 09096ｧ804o0ｸ 閨0ｹ ｧ ｹ0 appleo0ｸ ｸ o0ｸ ｧ9 030ｸ ｹ0 006ﾑ80ｸ70306apple090ｹ ｹ ｧ9 0ｹ003 appleo0ｸ7 apple ｨBfi O 6ｾ4026ﾑ86ﾑ8 040ｸ700apple apple6ｧ904090ｹ fi 閨03o0ｹ ｹ0 EFPIA. 6ﾒ2o ｸ7apple6ｧ ﾑ 閨 ｹ0 046ｦ o06 appleo0ｸ7 0002apple03o040ｷ3appleo6ｦ o0ｸ70ｹ o6 506o006ｧ804 07o0ｸ70ｹ0, 02o0ｸ70ｹ o6ｦ00ｹ o6 506o006ｧ804 07o0ｸ70ｹ0, 02o0ｸ70ｹ apple03o0406appleo0ｸ70ｹ0, 02o0ｸ70ｹ ｷ309006ｧ90ｹ o00006ｧ90ｹ0. ﾒ 07006ｧ90ｹ0 applefi 0ｸ702o6ｦ00ｹ0 02o0ｸ7 040ｸ707 閨0400o0ｸ70ｹ appleo03o6ｦ ｧ 閨03o0ｹ ｹ0 EFPIA ｧ apple03o040ｷ3appleo6ｦ apple030006o ｧ ｹ0 09o03070ｹ0 appleo0ｸ7 6ｧ apple 03 6ｧ apple03o00applefi fi ｧ applefi ｹ ｸ ｸ704090ｹ ｷ ｦ ｷ307 02fi ｸ707 閨04000ｷ o0ｸ703096ｧ9 02o0ｸ7 6ｾ4026ﾑ86ﾑ8 appleo0ｸ7 02o 1983 閨 fi0ｹ 閨03o0ｹ ｹ0 EFPIA. ﾞ0ｸ7026ｧ ｧ ｸ7apple6ｧ o appleo fi ｷ ｸ ﾑ8apple ｧ804000ｷ ﾑ ﾒ2 00 閨 o0ｸ7 6ｾ4026ﾑ86ﾑ ｦ0apple02o0ｸ ｧ o 90% 02090ｹ ｸ ｧ80ｹ0 09o03070ｹ o 6ｾ4026ﾑ86ﾑ8 閨 ｷ303006ｧ ｸ707o ｧ80ｹ ﾒ0ｸ76 5 閨 ｾ fi fi ｹ0 02o0ｸ ｸ7036ｧ90ｷ30ｹ0 02 apple 閨 ｸ702 6ｧ9, o 6ｾ4026ﾑ86ﾑ ｧ appleo0303 閨0ｹ ｧ9ｨBo07000ｹ ｧ ｹ ﾑ fi03030ｷ appleo036ｦ ｸ7006 5o036ｧ ｸ7appleo04026ｧ ｹ0 EFPIA ｹ 閨0ｹ0 00apple06020ｸ7046ｧ9000ｹ ｸ ｧ ｹ0 apple 03o0ｸ7046ｧ9 0ｹ0 04 0ｹ ﾑ , 00apple 閨 o0ｸ ｹ ｷ3 046ｦ00702o ﾑ ｧ ｸ ｧ8 ﾞ09o ｾ o ｧ 閨03o0ｸ ｧ ｷ o00000ｸ7036ｧ90ｷ o6ｧ9020ｷ307. ﾇ 040ｸ707o ｧ8 09o 閨0ｹ o ｧ9o0ｸ7 076ｧ o ,6 060ｹ0 6ﾑ80ｸ70306 apple 03o0ｸ ｨBo0702 0ｹ0 6ｦ ｸ702 6ｧ9 apple 閨 fi0706, 6ｧ apple00036ｧ9appleo0ｸ7 20% ｷ30ｹ fi ｸ ｹ0 00apple03o 閨00 02 appleo0ｸ7 apple03o04apple 03o6ｦ ｦ004o0ｸ ｾ4 ｯ 0ｸ702fi 02o ｧ9o 03 閨030ｷ o076ｧ9040ｷ fi o6ｧ appleo0ｸ7 00 0ｹ0 apple 03 閨 o ｧ9o 02090ｹ0 EFPIA ｹ ｸ701 閨 ｹ ｸ ｧ8040ｷ o o0ｸ7 Brian Ager ｧ ｹ0 Marie-Claire Pickaert, 02o 07o000602fi 02006ｧ800 appleo0ｸ ｸ7036ｦ Ann Robins fi03o 02o apple03o040ｷ3apple0602fi ｧ8 040ｸ ｧ ｸ7appleo04026ｧ ｦ004o0ｹ0 47 6ｾ4f6ﾑ86ﾑ8 9

10 13EFPIA ANNUAL MEETINGS ATHENS ｹ0 040ｸ70702o 閨07000ｹ 閨 ｹ0 02o0ｸ7 6ｾ4026ﾑ86ﾑ ｹ0 EFPIA 02 02o apple006ｧ904o0ｸ oapple06026ｧ8 06o6ｧ fi ﾑ apple03006ｧ ｹ0 o 09096ｧ9000ｹ ｹ0 6ﾑ8.6ﾑ8, appleo0ｸ7 o036ｧ9ｨbo0ｸ ｹ0 apple03o ｧ9000ｹ 閨 ｷ ｧ ｸ707 陦 ｧ9 000ｹ0 appleo0ｸ7 o ﾑ oappleo6ｧ9 09 Marie Claire Pickaert & o Phillip Elsworth 6ｧ ｦ00306o06 o 閨0ｹ0, 000ｸ oappleo066ｧ o0ｸ70ｹ0 appleo o6ｦ00ｹ0 00 0ｹ 閨 ｹ0 apple03fi ｹ0 020ｷ ｹ0 07 閨000ｹ apple006ｧ9000ｹ ｸ702fi 02o fiappleo fi fi o09036ｧ ｷ ｹ0 07 apple03o040ｷ3036ｧ 閨 ｧ800 apple06o 02o ｹ0 apple03o02036ｧ ｹ0 02o0ｸ7 07 鑰0ｸ7 apple o0702o0ｹ0 appleo0ｸ o0ｸ ｧ ﾑ80ｸ70306apple09, ﾑ80ｸ70306apple ｹ ｧ9 0ｹ ｯ fi03 0ｸ70207, fi0206 閨 ｧ fi. ﾇ o6 506o ｧ9 0ｸ7appleo040300o6ｦ fi ｧ ｧ8 04o030909fi0ｹ ｹ0 6ﾑ ｧ80ｹ0 O0602o07o006ｧ9 0ｹ oapple03fi ｦ06 7o0ｸ70ｹ ﾑ80ｸ70306, appleo04fi appleo0ｸ apple03o040ｷ3apple006ｦ 閨09 020ｷ o04o02o00006ｧ90ｷ307 apple03o0ｹ o ｧ9, o 閨03000ｹ0 apple6ｧ904020ｷ304090ｹ0 0100apple000307o6ｦ ｹ apple0ｷ30ｹ ｷ3036ｧ9ｨB fi03o06 o06 046ｦ o06, 09 6ﾑ ｧ ｦ00306 apple09096ｧ8 apple ｧ8030ｷ ｷ ｹ ｹ0 04 0ｹ0 03fi090ｷ ｹ ｧ80ｹ ｧ80ｹ ｷ ﾑ appleo0ｸ7 00apple ｧ o appleo0ｸ ｧ8 ﾞapplefi appleo0ｸ7 apple03fi apple09 applefi 02o 6ｾ40ｸ7006 5o6ｦ00306o 02090ｹ0 6ﾑ8apple ｧ9 0ｹ applefi apple03o04080ｸ7096ｧ8 02o0ｸ7 6ｾ4026ﾑ86ﾑ8. 6ﾒ2o o 046ｦ007o03o 020ｷ307 apple ｷ ｷ applefi ﾑ ｸ7appleo03o096ｧ9ｨB ﾑ80ｸ ﾒ2 0402o ｧ o 閨04o0ｸ707 o oappleo ｧ9 02fi ｸ7apple070304o0ｸ ｧ ｹ0 fi0206 o06 apple03o o09 閨0ｹ0 020ｷ ｷ307 appleo0ｸ7 00apple 閨020ｸ70400 o 6ｾ4026ﾑ86ﾑ8 02o07 apple 閨07o 0403fi07o applefi apple 閨0ｹ0 apple07090ｷ300, 00apple0903 陦 apple0ｷ30ｹ ｹ0 apple ｹ ｷ309 閨0ｹ0. 6ﾑ803apple6ｧ9ｨBo0ｸ70000 apple0ｷ30ｹ ｸ707 閨 ｷ307 apple03o o ｷ ｸ7026ｧ fi appleo0ｸ7 006ｧ ｹ o0ｹ0 020ｷ ｧ8070ｷ fi0206: ) o ｧ90ｹ o6ｦ o0ｸ70ｹ0 appleo0ｸ7 00apple o ) 陦 o6ｦ007 appleo ﾑ ｧ8 09o0307, ｹ 閨0ｹ 閨0ｹ0 appleo0ｸ7 apple 0602o6ｦ apple o6ｦ ｧ90402, appleo0ｸ7 03 apple03o02 03 閨 o fi o 02o0ｸ7 0702fi000607o (domino effect) ｹ ｹ0 09o03 閨0ｹ0 06 6ｧ90ｷ30ｹ0 020ｷ307 0ｸ7applefi 閨 ｷ , ｸ7030ｸ700 閨0709 6ﾑ80ｸ70306apple09. 6ﾑ86ｧ fi o01o06 fi0206 o06 apple03o ｹ ｹ0 o0007 o0ｹ0 G o0ｸ ｧ ｧ809o fi ｹ0 09o03070ｹ ﾑ ﾑ8apple06 6ｧ90ｷ o0ｸ7 6ｾ4026ﾑ86ﾑ8 006ｧ ｸ702fi ｧ ｧ809o fi ﾒ6ｦ appleo0ｸ70309, 09 6ﾑ80ｸ70306apple ｹ ｧ9 0ｹ0 o0602o o00006ｧ ﾑ ｸ7appleo040300o6ｦ appleo ｧ ｹ0 apple03o04 o026ｧ9000ｹ0 020ｷ307 02o0607o ｹ ｧ9030ｷ307. ﾞ ｹ0 fi03o06 o ｹ fi03o06 o06 6ﾑ80ｸ7030ｷ3apple 6ｧ9o06 appleo0ｸ apple0603 閨01o0ｸ apple o0ｸ ｹ oapple 閨0ｹ0 02o0ｸ ﾑ o0ｸ707 02o fi000007o 00apple6ｧ9apple00 o apple006ｧ9 0ｹ ｸ702fi ｧ apple o. 縺070ｷ3036ｧ9ｨBo0ｸ70000 fi ｧ90ｹ o06 040ｸ ｹ0 04 0ｹ0 apple 03 02o03o0ｸ703006ｧ90200 applefi 02o ｹ0 040ｸ7ｨB09026ｧ ｹ ｹ0 o0007 o0ｹ0 G ｧ 閨6 5 06o06 apple0ｷ30ｹ ｹ0 apple03o ｹ0 appleo0ｸ7 03 apple03o026ｦ06 7o0ｸ ｹ ｧ , ｹ0 0ｸ706o ｧ ｸ70003apple060402o6ｦ00000 fi ｹ fi ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

11 ｦ0030ｸ ｦ0030ｸ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｷ304090ｹ ｧ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｷ304090ｹ ｧ9 O ｧ9 02o0ｸ7 ﾒ 03. ﾒ. 6ｾ ｧ8 08appleo0ｸ ｦ ｧ9 0ｹ fi07o06 0ｹ ｹ 閨0ｹ ｷ3appleo 閨0ｹ 閨0ｹ ｹ ｧ9 0ｹ0 02o0ｸ7 ｯ ｹ ｹ ｹ0 ﾒ ｧ80ｹ ﾞ07 02o ｧ80ｹ0 6ﾑ80ｸ70306apple090ｹ ｸ703006ｧ9 0ｹ ｧ ｹ o6ｧ o06070ｷ ｧ o0602o07o ｧ8 ｨB0ｷ36ｧ8. ﾇ applefi 02060ｹ0 o0602o07o006ｧ9000ｹ o6ｦ o6ｦ ｹ0 o0602o07o006ｧ9000ｹ ｹ0 09o03070ｹ0 apple03o apple fi ｨC 閨0ｹ ｹ0 ｨC ｸ707 閨 apple036ｧ o ｷ o0ｸ7 02o06070ｷ o6ｦ o0602o07o000602o6ｦ0 040ｸ ｧ800 02o0ｹ0. ﾇ ｸ7026ｧ8 00apple 陦 ｸ709006ｧ9, 02o 0ｸ o07o000602fi 046ｦ appleo ｧ8 0ｸ709006ｧ9 0ｹ0. 6ｾ402060ｹ ｹ0 CEE apple ｧ 閨07 0ｹ fi0ｹ fi0ｹ0 apple03o ｷ ｦ ｹ ｹ ｹ0 6ﾑ8.6ﾑ fi : ｹ o 閨0ｹ 閨 o0ｸ7 0ｸ o07o000602o6ｦ0 02o00 陦, 020ｸ7036ｧ90ｷ30ｹ o04o02o 閨0ｹ ｧ907000ｹ ｸ ｸ7fi07020ｷ30ｹ0 0402o fi 020ｷ ｸ7apple ｸ70902 閨 ｷ o6ｧ o0ｸ7 040ｸ704026ｧ800 02o0ｹ0 0ｸ709006ｧ9 0ｹ0 09 0ｸ7appleoapple03o0408o o006ｧ8 0ｸ ｧ80ｹ o03o096ｧ9 0ｹ ｷ ｧ appleo fi ｹ0 apple03o04 o026ｧ9000ｹ0 020ｷ ｧ8 appleo fi ｷ307 0ｸ7apple ｸ709006ｧ9 0ｹ0 縺 apple ｦ ｷ307 apple03o ｷ 陦 ｧ ｸ fi ｹ0 02o0ｸ7 0ｸ o07o000602o6ｦ0 02o00 陦 閨 apple020ｸ ｧ9 applefi 02060ｹ 閨0ｹ ｹ ｧ9 0ｹ0 02o0ｸ7 ｯ90, 09 oappleo6ｧ9 apple ｸ7036ｧ90ｷ30ｹ0: applefi 02o fi 046ｦ ｦ0appleo0ｸ7 Semasko ｷ3096ｧ ｹ0 02o06070ｷ ｧ80ｹ ｹ0 026ｦ0appleo0ｸ7 Bismark, o03o0ｸ70ｹ0 o ｷ o6ｦ00ｹ0 026ｦ0appleo0ｸ70ｹ appleo02 閨 ｷ ｧ appleo ｷ apple 閨0ｹ oapple0602 閨0ｹ 閨0ｹ ｧ ｷ oappleo6ｧ ｸ7apple , 020ｸ7036ｧ90ｷ30ｹ apple030ｷ302o apple00036ｧ ( ｧ9 ) ｧ fi 00 閨03o0ｹ0 020ｷ307 07o04o02o00006ｧ90ｷ ｧ90ｷ ｸ7appleo o fiapple0ｷ30ｹ0 020ｷ307 07o04o02o00006ｧ90ｷ ｷ ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 11

12 13EFPIA ANNUAL MEETINGS ATHENS 2003 ﾇ 閨 ﾑ8.6ﾑ ｧ ｧ8 appleo o046ｧ ｷ ｸ : ｦ ｧ ｷ307 00apple ｸ709006ｧ9 0ｹ ｦ ｧ ｦ ｧ , 0ｸ7apple ｧ90ｷ307, ｧ ｷ307, o03o096ｧ9 0ｹ0, 00apple0007 6ｦ004000ｷ307 ﾇ 06006ｦ0030ｸ ｹ0 6ﾑ8.6ﾑ8. 03 閨 o ｨB09026ｧ oappleo6ｧ9 apple03 鐶pple ｷ3apple060403o6ｦ o0607 閨0ｹ0 appleo 閨0ｹ0 fiapple0ｷ30ｹ0 o 閨 o0ｹ0 020ｷ307 03o06000ｷ fi ｷ307 07o ｷ307, 09 apple03fi ｷ ｸ ｷ307, ｸ o046ｧ800 02, ｷ , o 閨 o0ｹ0 020ｷ o086ｧ9000ｷ307, 02o apple o fi ｧ90ｷ ｹ0 apple03fi ｹ ｹ0 appleo06fi ｹ0 020ｷ307 0ｸ7apple ｸ709006ｧ9 0ｹ0. O06 02o0607 閨0ｹ0 apple03o02036ｧ ｹ0 appleo0ｸ ｷ3apple6ｧ9ｨBo0ｸ707 o ｹ ｹ ｦ0030ｸ ｹ0 006ｧ appleo0303 閨0ｹ o06 020ｸ70306fi ｹ0 040ｸ707o6 76ｧ9ｨBo : o6ｦ00ｹ0, ｧ80ｹ ｸ707o ｧ80ｹ0 040ｸ ｧ9 0ｹ ｹ0 0604fi ｹ0, 02090ｹ0 apple03fi ｹ ｹ0 appleo06fi ｹ ｹ0 0ｸ709006ｧ9 0ｹ fi ｹ0 07o00o ｧ9 0ｹ apple020ｸ ｷ ｷ ｷ ｷ307 appleo o096ｧ8 030ｸ703006ｧ904000ｷ apple03o o096ｧ ｹ0 07 閨000ｹ o03o096ｧ9000ｹ ｦ ｷ307 applefi030ｷ ｸ709006ｧ apple020ｸ ｹ0 appleo ｧ80ｹ0 6ﾒ2 02o o08 閨 oappleo6ｧ9 00appleo03006ｧ9 07 apple03o026ｦ06 7o0ｸ707 applefi 閨 ｸ7036ｧ90ｷ30ｹ0 applefi apple03o04apple ｸ ｷ ｷ fi ｦ ｧ907 06: ｦ ｧ apple ｸ709006ｧ9 0ｹ ｧ90ｷ ｹ0 appleo06fi ｹ0 0ｸ7apple ｸ7appleo o ｧ90ｷ o0ｸ7 00apple06apple 陦o0ｸ7 0ｸ709006ｧ9 0ｹ ｹ0 apple03fi ｹ ｧ90ｷ ｷ307 applefi030ｷ307 0ｸ709006ｧ9 0ｹ ｸ ｷ ｹ0 0900fi0406 0ｹ0 0ｸ709006ｧ9 0ｹ ｧ80ｹ0 040ｸ ｧ9 O06 apple03o02036ｧ ｹ apple03o04 o o08 閨 appleo03006ｧ9 07 apple03o026ｦ06 7o0ｸ707 applefi ｧ8 040ｸ ｧ apple6ｧ ｧ o fiappleo 036ｧ ｹ0 appleo ｷ ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

13 13H ｧ9 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ8 ﾞ H ｧ9 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ8 ﾞ 閨 ｹ ｹ0 apple 閨0ｹ0 0ｸ709006ｧ9 0ｹ00ｸ709006ｧ ｷ ｧ ｷ ｧ ﾞapplefi04apple 0400 applefi ｧ ｹ0 02 0ｹ ｹ apple086ｦ003080ｸ7* 6ﾑ8apple060203fiapple080ｸ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ0 6ﾑ8apple apple6ｧ80ｹ ﾞapple 0404fi ｹ ｷ 閨0ｹ0 0ｸ7apple0803 閨 ｹ0 6ﾑ86ｧ o0ｸ ｦ0010ｷ3 046ｧ ｨB6ｧ9 04 0ｹ 閨 ｷ ｸ702o6ｦ0 02o0ｸ7 040ｸ700appleo046ｧ9o0ｸ 閨 ﾑ80ｸ70306apple ｹ0 0ｸ709006ｧ9 0ｹ ｹ0 07 閨000ｹ ｸ ｧ9000ｹ0 appleo0ｸ7 apple03o0408 閨 o0ｸ70ｹ ｧ90ｹ0.6ｾ46ｧ ｧ ｧ ｸ7026ｧ ｸ7ｨB6ｧ 縺06 026ｧ ｷ300 閨0709 6ﾑ80ｸ70306apple09, ｸ704026ｧ ｸ709006ｧ9 0ｹ appleo020003o6ｦ007 appleo00o070ｷ300 閨07000ｹ ｧ9 000ｹ0, apple03 鐶pple ｸ ｧ9ｨBo0ｸ707. ﾇ 000ｸ7030ｷ3apple 0ｸ8026ｧ8 o03o02036ｧ8030ｷ o036ｧ9ｨB 閨 閨 ｧ8 02o0ｸ70ｹ0, 02fi ｸ702fi 00appleo03006ｧ apple036ｧ ｧ ｸ ｧ9 fi04o0ｸ70ｹ0 apple ｦ0o0ｸ707 fi ｸ704026ｧ o06070ｷ ｧ80ｹ0 apple03o ｧ9 0ｹ0 00appleo03o6ｦ007 02fi ｨBo0ｸ apple000306o036ｧ9ｨbo o0ｸ70ｹ0 046ｦ007o03. ﾇ 06006ｦ0030ｸ 鐶pple ｧ ｸ7026ｧ ｸ7ｨB6ｧ ｧ ｦ0030ｸ ｧ , appleo o00o03086ｧ ｷ ｧ fi ｦ 閨 ｷ ｹ0 oappleo6ｧ9000ｹ0 o06 00apple06 fi ｹ0, o appleo04o0402fi 02o0ｸ7 ﾞ6ﾑ809 appleo0ｸ ｧ ｸ709006ｧ9, apple 閨07o0ｸ 閨0ｹ 閨0ｹ fi ｹ0 applefi ｧ907000ｹ0 appleo0ｸ ｷ3036ｧ9ｨBo0ｸ ｷ ｷ apple 閨 閨07 apple03o04 fi020600o ｨB0ｷ36ｧ80ｹ fi020003o fi0706 applefi 02o 00 閨04o fi03o 02090ｹ ｷ304090ｹ o0ｸ70ｹ ｹ0, fi0706 apple00036ｧ9appleo0ｸ ｹ0 090ｸ7-07 6ｧ902000ｹ0, ｧ907o0ｸ70000 apple06o 006ｧ o 00 閨090003o0ｹ ｹ0 apple03ofi o0ｸ7 appleo0ｸ7 apple03 鐶pple ｷ303006ｧ9, oappleo6ｧ o fi07o 02o 046ｦ ｸ709006ｧ9 0ｹ0, o06070ｷ3076ｧ ﾇ 0ｸ709006ｧ9, 0ｷ30402fi04o, appleo ｧ9 02o apple030602o 040ｸ fi 0402o ｧ9o 02o0ｸ apple0607o0ｸ ｧ9o0ｸ703, ｸ702fi o0ｸ7 02o07 apple030ｷ fi apple o ｹ ｷ fi ｹ ｹ0 o0602o07o ｧ80ｹ0 0707apple020ｸ701090ｹ ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 13

14 13EFPIA ANNUAL MEETINGS ATHENS 2003 O06 02o0607 閨0ｹ0 apple03o02036ｧ ｹ0 O fi0ｹ0 03fi09o0ｹ0 fi000ｷ30ｹ o07 oappleo6ｧ9o apple03 鐶pple ｧ ｸ7ｨB6ｧ ｸ7026ｧ8 006ｧ o06 02o0607 閨0ｹ0 apple03o02036ｧ ｹ o ｷ3036ｧ9ｨBo0ｸ70000 fi0206 o06 apple03o02036ｧ ｹ0 0ｸ702 閨0ｹ0 006ｧ ｹ0 0ｸ709006ｧ9 0ｹ0, ｦ 閨030ｷ ｷ , o 閨0ｹ ｹ0 02o06070ｷ3076ｧ9 0ｹ0, o03o ｧ8 apple03fio o0ｹ0. ﾇ fi apple ｯ fi03000ｹ0 006ｧ ｧ96 5o o ｧ8 096ｧ , appleo02 閨 ｹ0 oappleo6ｧ9 0ｹ ｧ ｦ o0ｸ7 appleo04o0402o6ｦ0 020ｷ307 02fi000ｷ ｷ3 020ｷ , applefi ｧ9, applefi 16% % 02o0ｸ7 040ｸ707o030602o6ｦ0 apple ｸ70400o6ｦ ｧ8 040ｸ707 鐶pple ｹ ｦ ｹ0 0ｸ709006ｧ9 0ｹ ｹ0 appleo fi ｹ0 020ｷ ｸ ｷ307 apple00036ｧ ｹ fi04o, o06 apple ｹ ｸ709006ｧ9 0ｸ o appleo036ｦ ｧ9 020ｷ fi0009 apple fi020003o ｧ9 020ｷ O o6ｧ9, ｷ307 oappleo6ｧ90ｷ307 ｨB6ｧ ﾑ8apple060203oapple6ｧ8, o6ｦ007 fi0206 o fi ｹ0 apple ｹ ｸ709006ｧ9 03 0ｸ o6ｦ 閨0ｷ30ｹ0 1,5 appleo04o ｧ9000ｹ0 00o ｹ0 02o0ｸ7 ﾞ6ﾑ809 閨0ｷ30ｹ0 02o fi090ｷ ｹ0 096ｧ ｹ0. 6ﾑ80202fi0ｹ0 applefi ｦ ｸ7026ｧ8 apple03 鐶pple ｸ o6ｦ o ｹ0 040ｸ707 鐶pple ｹ ｹ0 096ｧ ｹ0, ｹ0 040ｸ ｹ0, 0906 apple ﾇ 6ﾑ80ｸ70306apple09 00appleo00 閨070ｷ30ｹ0 apple03 鐶pple ｸ ｧ ｹ0 apple03o04apple 閨0ｹ ｹ o o 閨0ｹ 閨0ｹ0 020ｷ ｷ300 閨070ｷ appleo03 閨04o0ｸ ｨB6ｧ804o0ｸ707 apple fi020003o, ｦ ｸ709006ｧ9. ﾞ0ｸ702fi ｧ ｯ ｹ0 02o appleo02 閨 ｷ307 appleo apple03fi ｹ ｷ3096ｧ80ｹ0 0ｸ709006ｧ9 0ｹ0, appleo0ｸ ｧ90402o o 00apple6ｧ o 02090ｹ0 02o0607o ｧ80ｹ ｧ80ｹ0 0ｸ709006ｧ9 0ｹ o ﾞ0ｸ702fi ｧ apple6ｧ904090ｹ o appleo02 閨 ｹ0 閨03000ｸ707 0ｹ ｹ o02o006ｧ9 0ｹ ｹ o ｧ9 0ｹ0 04 0ｹ0, 06 6ｧ90ｷ30ｹ0 0402o07 appleo ｸ7appleo0404fi o 02o00 陦 020ｷ appleo0ｸ7 040ｸ707 鑰 ｧ9. O03o02036ｧ8030ｷ30409, 06006ｦ0030ｸ , 02o0607 閨0ｹ0 apple03o02036ｧ ｹ0, ｹ0 applefi 0ｸ7026ｧ ｹ0 096ｧ ｹ0: 6ｧ o0ｸ fi ｸ7030ｷ3apple 0ｸ8026ｧ8 040ｸ ｧ9 apple06o ｧ ｸ7apple ｧ9 02o0ｸ7 02o0607o6ｦ0 o o0ｹ ｸ709006ｧ ｸ ｧ9 appleo0ｸ7 apple03 鐶pple ｷ3036ｧ o ｧ o ｧ803 02o0ｸ o6ｦ0 020ｷ ｸ700appleo ｹ o 046ｦ ｸ709006ｧ9 0ｹ0 02o0ｸ70ｹ0. O fi0ｹ0 0ｸ702fi0ｹ0 006ｧ ｧ o0ｹ ｧ9 o06 040ｸ700appleo036ｧ902000ｹ0 00 0ｹ ｷ3036ｧ9ｨBo0ｸ707 fi ﾑ80ｸ70306apple09 006ｧ apple000306o046ｧ8 02o0ｸ7 02fi0400o0ｸ7 appleo0ｸ7 apple 03 閨 ｦ apple00036ｧ ﾑ86ｧ ｧ o ｦ o apple03o04 fi020600o ｨB0ｷ36ｧ80ｹ0, 02o oappleo6ｧ9o 0ｸ7016ｧ 閨 ｹ ｸ702 6ｧ9 0ｹ o ｧ9 0ｹ0. ﾒ ｧ o ｧ8 apple00036ｧ9o o 09 apple ｧ fi , apple ｹ appleo04o0402fi fi020003o 02o0ｸ7 5 ｨｰ apple000307o6ｦ o 23 ｨｰ o 00 閨03o0ｹ0 020ｷ307 00apple06020ｸ ｸ appleo03006ｧ9 07 appleo o03006ｧ ｸ704026ｧ ｸ709006ｧ9 0ｹ0, ｧ9 o08006ｧ apple03fi , ｷ307o04o02o ｧ o04o02o ｧ8 apple00036ｧ , ｹ o fi ｧ8 02o0ｸ70ｹ0 appleo0ｸ ｧ9ｨB ｸ703006ｧ ｸ o0ｸ7 apple ｸ70400o6ｦ0. ﾞappleo020003o6ｦ007 00appleo00 閨070ｷ30ｹ0 040ｸ fi 0402o ｧ9o 020ｷ ｸ o0ｸ7 02o06070ｷ o6ｦ0 00 0ｹ0 00o0702 閨03o0ｸ7. 6ｾ402o ｧ9o 02o oappleo6ｧ9o 閨 ｷ ｧ9 applefi 02o ｷ ｷ ｷ ｷ307 appleo0ｸ ｧ o 閨 o 02o0ｸ7 2000, fiappleo0ｸ ｦ fi0206 fi03o06, applefi 02o 00apple6ｧ9apple00 o o 6ｧ o0ｹ0, 閨04o0ｸ ｧ90ｷ300 apple03fi ｹ appleo06o 閨0ｹ0 0ｸ7apple ｧ9000ｹ0 apple03fi ｹ apple00036ｧ ｹ ｷ ｧ9 00apple6ｧ904090ｹ0 applefi ｾ40ｸ707036ｧ80209, 09 oappleo6ｧ ｷ3036ｧ9ｨB apple030ｷ ｧ8 0300o 06fi ｷ fi04o07 08o o ｷ o fi ｷ ｸ ｷ307 0ｸ709006ｧ9 0ｹ ｹ0 02o06070ｷ ｧ80ｹ0 apple03o ｧ9 0ｹ0. O06 040ｸ700appleo036ｧ902000ｹ0 00 0ｹ0, 00 閨040ｷ3 020ｷ apple03o0406apple0ｷ307 02o0ｸ70ｹ ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ8 6ｾ40ｸ707 閨03000ｸ70409, ｨBo0ｸ ｧ8 00apple06030ｸ7006ｧ9 02o0ｸ70ｹ ｧ9 0ｸ7026ｧ8 09 0ｸ7apple0003o046ｧ ｹ ｧ80ｹ ｹ0 00apple0602o0ｸ fi ｹ0 0402o o fi 046ｦ apple0ｷ30ｹ0 fi000ｷ30ｹ0 00apple06030ｸ700o6ｦ apple020ｸ apple ｧ80ｹ0 6ﾑ80ｸ70306apple090ｹ ｹ0 0ｸ709006ｧ9 0ｹ0. ﾞ 閨020ｷ3apple ｹ0 apple03o02036ｧ ｹ0 0ｸ702 閨0ｹ0, ｧ ｸ70207, appleo0ｸ7 appleo0303 閨0ｹ0 08o03 閨0ｹ0 006ｧ , ｷ30409 apple03o040ｷ303006ｧ ｦ o o016ｧ9. 09o03006ｦ ｦ0o 0701o07000ｹ0: 02o ｸ o fi 02o0ｸ ｧ9o0ｸ7, oapplefi apple 閨030ｷ3 apple03o ｹ ｦ ｹ0 020ｸ70203o08o036ｧ9 0ｹ0 020ｷ307 02fi000ｷ307, apple020ｸ fi0ｹ0 000ｸ7030ｷ3apple 0ｸ802o6ｦ0 040ｸ70702o o6ｦ0 020ｷ307 appleo o06070ｷ ｧ8 apple03o ｧ9, o06 apple03o02036ｧ ｹ ｷ3apple060402o6ｦ007 applefi 02o0607o6ｦ0 閨04o0702 0ｹ0 0ｷ30ｹ apple ｧ ｹ0 6 5 閨 ｹ0 apple 閨0ｹ0 02o0ｸ fi0ｹ ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

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18 13EFPIA ANNUAL MEETINGS ATHENS ｾ40ｸ707 0ｸ707ｨB ｹ0 0ｷ308 閨 ｸ70ｹ ｧ90ｹ ｧ8 000ｸ7030ｷ304026ｧ ﾑ80ｸ70306apple09 O 0903fi00 03o0ｹ ｹ0 EFPIA, Sir Tom McKillop, 00apple ｧ ｨB0ｷ ｧ ｧ809o o ｧ8 apple03fi o ｷ apple ｹ ｸ ｧ80ｹ ｸ707 0ｹ ﾞ0707apple020ｸ701090ｹ0 apple03o0ｹ0 fi080003o0ｹ ｹ ｷ fi ｹ ｹ0 000ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ o6 506o ｧ9 0ｹ ｷ ｷ307 6ﾑ80ｸ7030ｷ3apple 6ｧ90ｷ ANNUAL MEETINGS 2003 ﾇ 0900fi0406 0ｸ709006ｧ ｧ o030ｸ7086ｧ ｹ0 036ｧ ｹ0 apple03o o026ｧ8020ｷ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ0 02ｨB 閨0702 0ｹ0, apple 閨07o0ｸ fi0ｹ0 apple o0702 0ｹ ｧ90ｷ ｷ307 apple03o fi ｷ307 0ｸ7apple ｧ9 0ｹ0 0402o0ｸ70ｹ0 appleo036ｧ902000ｹ0. 6ﾑ86ｧ o07fi0ｹ0 fi ﾑ80ｸ70306apple ｧ9ｨB o6 506o ｧ apple0007 6ｦ ｹ ｸ ﾞ0707apple020ｸ ｧ o6ｧ8 apple ｷ3096ｧ80ｹ0 07 閨0ｷ 閨070ｷ ｸ apple03o0ｸ8fi07020ｷ o 00 閨0303o07. 6ﾑ8 06, ﾞ036ｧ807, ｸ fi ｹ0 EFPIA, 0906o030207ｨBo0ｸ 閨0ｹ0 applefi 02060ｹ ｦ ｹ0 040ｸ o03 閨0ｹ0 appleo0ｸ7 閨 o apple fi ｸ ｧ8 閨03000ｸ o0ｸ ｹ0 apple06o 閨03o0ｸ704000ｹ ｧ ｹ0 02o0ｸ7 00 閨0303o0702o0ｹ0. 00 ﾞ0ｸ7026ｧ8 09 apple00036ｧ9o o0ｹ0 006ｧ appleo036ｦ 閨03o0ｸ fi04o0ｸ70ｹ0 0404o03o6ｦ ｸ ｧ8 閨03000ｸ apple ｧ o Sir Tom McKillop, apple03fi00 03o0ｹ ｹ0 EFPIA. 006ﾒ2 00apple o o03o apple ｦ ｧ907o0ｸ ｸ707 02fi o0ｸ70ｹ ｸ 閨0ｹ o04006ｦ0o0ｸ fi03o apple06o appleo036ｦ0apple03o02000ｹ ｹ0. ﾇ apple ｧ8, fi000ｷ30ｹ0, 040ｸ o ｷ ｸ ｧ8 apple03fio o, ｧ 閨6 7o0ｸ ｹ ｦ ｹ0 020ｷ ｸ apple030ｷ302oappleo 閨0ｹ apple006ｧ9000ｹ0 appleo0ｸ ｧ ｸ703 閨0ｷ30ｹ 閨 ｹ0 0402o 02o0607fi apple030ｷ302oappleo ｧ ｸ ｧ o ｧ apple 6ｧ9ｨB0006, apple0307, fi 03fi03o ｧ90ｷ ｷ ｸ7030ｷ3apple 0ｸ apple03o ｸ709006ｧ9 0ｹ0, ｸ 閨 閨 ｸ7030ｷ3apple 0ｸ8026ｧ8 o0602o07o006ｧ9, 000ｸ ｧ fi ｷ ｸ ｧ804000ｷ ｷ307 appleo fi04o, 03 apple03 鐶pple o6ｦ appleo06o06 apple03o o6ｧ o 閨04o0ｸ ｧ9 o06 040ｷ30402 閨0ｹ0 appleo ｹ o 閨0ｹ0 00apple0007 6ｦ ｹ0 0402o07 02o00 陦 apple 03o046ｧ80ｹ0 0ｸ7apple ｸ709006ｧ9 0ｹ ｹ o6 506o ｧ9 0ｹ ﾑ80ｸ70306apple09. ﾇ ｸ ｧ ｸ ﾞ0707apple020ｸ ｧ fi o 02fi0402o0ｹ ｧ90402o. 6ﾑ80706 o 00 閨04o0ｹ0 fi03o0ｹ0 0707apple020ｸ701090ｹ ｷ ｧ fi fi0402o0ｹ ﾑ80ｸ70306, ｸ7apple apple ｧ ｦ apple06020ｸ7046ｧ9. 006ﾒ2 閨02o06 02fi appleo03o6ｦ o6ｦ00703, 03 閨0006 o Sir Tom, 0000fi07o 0400 閨 ｧ900 appleo0ｸ ｸ707o006ｧ o02o006ｧ9, apple 03 閨04o0702 0ｹ0 026ｧ ｸ7appleo04026ｧ ｸ ﾞ0707apple020ｸ70109, ｸ702fi0403o o0ｸ ｧ o0307 閨07 apple o07 appleo0ｸ apple 鐶pple ｧ809o o ｧ8 apple03fi apple03o0ｸ8fi0702 0ｸ7026ｧ80ｹ ｹ0 閨03000ｸ707 0ｹ0. 6ﾑ86ｧ ｸ7apple0903fi 02o o07fi0ｹ0 fi ﾑ80ｸ70306apple09 006ｧ ｸ702 6ｧ fi020003o ｸ ｧ8 09o apple0007 6ｦ ｹ ｸ ﾞ0707apple020ｸ70109, 閨 ｹ0 ﾇ09 ﾞ, ｦ ｹ0 000ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｹ ｸ707 0ｹ ﾞ0707apple020ｸ701090ｹ ﾇ o6 506o ｧ ｷ304o036ｧ9ｨB ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

19 ｸ ｧ appleo0602o o fi o09o appleo0ｸ o0ｸ703096ｧ applefi 02o G10, 0ｷ30ｹ0 apple ｧ ｸ7046ｧ9 appleo0ｸ7 apple03o02036ｧ applefi ｹ ｷ fi ｹ ｹ0. 6ﾒ ｧ ｧ fi03o0ｸ70ｹ0 02o0ｸ70ｹ0 0000apple030002fi000007o0ｸ70ｹ ｸ ｧ904o0ｸ707 02o o09o o06 040ｸ ｹ0 02o0ｸ7 G appleo6ｦ apple , 03 閨0006 o Sir Tom. ﾇ 07 02o6ｧ9070ｷ ｹ0 ﾒo fi07, appleo0ｸ 閨 fi04o 閨03o07, ｧ applefi04o apple03o0002o 閨 ｧ ﾑ80ｸ70306apple applefi ｦ ｸ 閨 ｧ 閨02o ｷ3apple6ｧ ｹ ofi ｹ ｹ0 09o03070ｹ o ｧ8 apple03fi 陦 appleo0ｸ7 apple03o ｧ applefi 閨 ｹ ｧ9 0ｹ0 09o03070ｹ ﾇ o6 506o ｧ ｨB 閨 fi apple03 6ｧ90406o apple 0902fi040006o0ｸ o6ｦ00ｹ0 apple03o 閨07o0ｸ7 07 apple 03 閨 ｹ0 00apple ｧ ｹ0 02o0ｸ o0ｸ fi ｧ809o0309 apple03fi o0307. ﾞ o 6ｧ9 06o ｦ o ｧ8, ｹ0, fi04o apple06o appleo o6ｧ9 006ｧ o fi07000ｹ0, 02fi04o ｦ ｸ707 02fi 閨 o ｧ80ｹ apple06o 09036ｧ809o 閨0709 apple03fi o08 閨 閨0ｷ apple ﾞapplefi ｹ1o0ｸ ｧ apple fi020003o fi applefi appleo ｧ904o0ｸ70000 fi0206 o appleo6ｧ9 020ｷ307 00apple0007 6ｦ004000ｷ ｹ o6 506o ｧ9 0ｹ o060307ｨBo ｧ ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ8 ﾒo0607fi , 0000 appleo036ｦ 閨0ｹ o03 閨0ｹ0 0ｷ30ｹ0 apple03o0ｹ o0602o07o ｧ8 02o0ｸ70ｹ ﾒ2 閨03o0ｹ0, o Sir Tom McKillop ｧ : ｸ7036ｧ o6 506o ｧ ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ ｷ30409 appleo ｧ ｧ o0602o07o ｧ8 00apple06020ｸ7046ｧ ｹ0 6ﾑ80ｸ70306apple090ｹ0 046ｧ 閨0306o ｦ ｸ709006ｧ fi03o0ｸ70ｹ0 02o0ｸ70ｹ0 6ﾑ80ｸ7030ｷ3apple 6ｧ9o0ｸ70ｹ0 6ｦ00306o. 6ﾑ86ｧ o 04 閨0306 fi030ｷ ｹ0-020ｸ ｧ804000ｷ307, 07o00o , 6 506o ｧ9 0ｹ0, 0ｸ7apple ｸ709006ｧ9 0ｹ , apple07070ｷ3 applefi fi03, o0ｸ703 閨6 7o0ｸ ｨB6ｧ apple o0ｸ ｸ709066ｧ o6 506o ｧ9 apple03o0ｹ0 fi080003o0ｹ0 020ｷ o00000ｸ7036ｧ90ｷ307 appleo ｹ ｸ7030ｸ700 閨07090ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｷ304090ｹ ﾒ2o ｧ ｹ0 040ｸ o03070ｹ ｹ ｸ ｧ80ｹ o ｧ9 0ｹ0 006ｧ o0ｸ ｸ7036ｧ ｹ0 閨03000ｸ707 0ｹ apple030ｷ302oappleo 閨0ｹ apple006ｧ9000ｹ0 appleo0ｸ appleo03o6ｦ ｧ ｸ703 閨0ｷ30ｹ o00 閨07000ｹ003 ﾞapplefi 閨07080ｸ Public Relations Officer (Roche) 02006ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 19

20 13EFPIA ANNUAL MEETINGS ATHENS 2003 G-10 ﾌ ｦ0 6ﾑ8apple06apple 陦080ｸ7 G-10 ﾌ ｦ0 6ﾑ8apple06apple 陦080ｸ ｧ ｧ ﾇ O o6ｦ0 6ﾑ8apple06apple 陦o0ｸ o02o006ｧ appleo07o00 ｨBfi G-10 appleo ｧ apple ｧ ｸ7046ｧ appleo 0ｸ ｷ ｹ ｷ fi ｹ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ o6 506o ｧ9 0ｹ0. ﾇ o0007 G-10 appleo ｧ applefi 02o0ｸ70ｹ0 00apple6ｧ90203oappleo0ｸ70ｹ0 Erkii Liikanen 縺 /07046ｧ8 6ﾑ8apple ｧ804000ｷ o08fi ｹ David Byrne 縺 / ｧ9 0ｹ o ｧ9 0ｹ0 ﾒ ｷ , 02o0ｸ70ｹ0 08appleo0ｸ70309o6ｦ00ｹ0 apple 閨 ﾒ ( 罍 03036ｧ9, 縺 ｧ9, 09o0302o09 036ｧ9, 6ｾ4o0ｸ709 6ｧ9, ﾇ ｧ o) 0002apple03o0406appleo0ｸ70ｹ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ0 0806o ｧ9 0ｹ ｷ fi ｷ ﾇ o0007 apple 03o0ｸ7046ｧ 閨 ｹ0 0402o fi00 03o 02090ｹ0 Commission Romano Prodi (090706o0ｹ0 2002) o 6ｾ40ｸ7006 5o6ｦ00306o 08appleo0ｸ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｷ304090ｹ0 (ｦﾐo6ｦ00706o0ｹ0 2002). ﾇ 閨0209 appleo ｧ applefi ｸ ｹ0 (recommendations) 閨0ｹ0 applefi 02060ｹ0 oappleo6ｧ9000ｹ0 apple 03o0ｸ ｨBo0ｸ o 閨03o o ｧ9. O ｸ ｹ0 006ｧ907 06: 09 H 6ｾ46ｦ I ｨB ｧ ｧ8 apple 03 02o03o6ｦ ｷ ｾ40ｸ ｧ80ｹ0 ﾞ0106o03fi ｹ0 (benchmarking and performance indicators) 02090ｹ0 applefi o04090ｹ ｹ ｸ ｧ80ｹ o ｧ9 0ｹ 閨 o0ｸ70ｹ0 006ｧ ｹ o ｧ80ｹ ｷ fi ｹ apple03fi apple006ｧ9 07fi040ｷ ｦ0070ｷ307 appleo0ｸ7 apple000603o6ｦ ｸ709006ｧ o o00 閨07 07o040903fi ｹ0, 040ｸ700apple o0702 0ｹ appleo fi ｷ ｸ apple03o0ｸ8fi07020ｷ 閨 ｦ ｹ0 o006ｧ80ｹ0 020ｷ307 O ﾑ ｧ904000ｷ ｹ0 6ﾑ ｷ304090ｹ ｷ307 ﾒ ( o036ｧ ｹ0 020ｸ70203o08o036ｧ9 0ｹ0, 02o o fi ｧ80ｹ ｸ applefi o06070ｷ ｧ ) ｹ0 apple03fi ｹ0 020ｷ 陦 (0403fi07o0ｹ0 appleo0ｸ7 apple ｧ 閨 , 0403fi07o0ｹ0 appleo0ｸ7 apple ｧ ｸ70203o08o036ｧ o0307). 09 ﾇ 6ｾ46ｦ ｦﾐｦﾐ ｨB ｧ ｦ ｹ ｧ9000ｹ0 閨 ｹ ｷ303006ｧ ｧ904o o0ｹ0 020ｷ 閨0ｷ ｷ o o0ｸ703096ｧ ｧ9 0ｹ ｧ9 0ｹ0 閨 ｹ appleo0ｸ7 006ｧ applefi 07appleo fi0406 0ｹ ｧ9 0ｹ0. 6ｾ40ｸ70702fi00000ｸ ｹ ｧ9 0ｹ0 036ｧ ｹ0 appleo ｷ307 (decision making process) ｧ8 02o0ｸ7 0403fi07o0ｸ7 appleo0ｸ7 apple ｧ ( 閨 ｷ ｷ ｧ ｧ9 ) applefi ｷ300o fi ｹ0 CPMP (02o0607o ｧ8 00apple060203oapple6ｧ8 閨 ｹ ｷ307) 00 閨 閨02 o ｹ ｹ0 020ｸ70203o08o036ｧ9 0ｹ0 applefi Commission. 09 ﾇ 6ｾ46ｦ ｦﾐｦﾐｦﾐ ｨB ｧ9 applefi 02 ﾒ 閨 ｸ70702o00006ｦ004o0ｸ707 02o 0403fi07o appleo0ｸ o ｧ9 applefi o036ｧ ｹ ｹ0 020ｸ70203o08o036ｧ9 0ｹ0 0007fi0ｹ o0ｸ7 00 閨 o ｧ ｧ8 02o0ｸ ｧ ｧ ｷ ｷ307 appleo0ｸ ｦ0apple02o applefi o06070ｷ ｧ ﾇ O 09096ｧ9 89/ ｹ0 6ﾑ ｷ304090ｹ0 apple03o6 503 鐶pple0006 fi0206 o ｧ9000ｹ o o6ｦ ｧ80ｹ 閨 ｹ0 020ｷ ｷ ｧ90402 apple03 鐶pple o03o o fi0ｹ H 6ｾ46ｦ ｦﾐV apple , ｸ ｸ o generics ｸ ｧ ｧ904 0ｸ70409 generics o0307. ﾌ6ﾑ8apple6ｧ apple080ｹ0 Erkii Liikanen 20 6ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

21 13 ﾌ6ﾑ8apple6ｧ apple080ｹ0 David Byrne 09 ﾇ 6ｾ46ｦ VI appleo ｧ9 02o apple030602o 6 56ｧ ｧ9 09o ｷ o ｷ fi (competition based). To apple020602fi 02090ｹ0 046ｦ ｹ0 006ｧ fi o 06fi fi0ｹ0 ﾒ030702o0ｸ70ｹ0/09 閨03o0ｸ70ｹ o o fi 02090ｹ ｧ80ｹ0 020ｷ ｷ307 apple03 鐶pple o fi07o appleo0ｸ ｦ0apple02o applefi 02o06070ｷ ｧ ｧ8 appleoｨb o applefi 02o ﾒ030702o0ｹ0. ﾞ0ｸ702fi ｧ o0ｸ 閨0904o0ｸ : 09 6ﾒ2 OTC 09 6ﾒ appleo0ｸ ｦ0apple02o applefi o06070ｷ ｧ ﾒ2060ｹ0 apple0ｷ3036ｧ ｹ ｷ o ｷ fi 02o00 陦 09 ﾇ 6ｾ46ｦ VII 閨 閨 fi0402o0ｸ70ｹ0- appleo fi ｹ apple03o6 503 鐶pple apple020ｸ ｹ0 0106o03fi ｹ ｹ o03o096ｧ9 0ｹ0 0ｸ709006ｧ9 0ｹ0 (health technology assessment). 09 O06 6ｾ40ｸ ｹ0 VIII IX 閨03o apple020ｸ ｹ0 閨03000ｸ707 0ｹ ｸ ｧ9 6ﾑ80ｸ7030ｷ3apple 0ｸ802fi0ｹ0 O fi0ｹ o09o0ｹ0 02o0ｸ7 National Institute of Health 020ｷ307 ﾇ09 ﾞ, ｸ7appleo04026ｧ ｹ0 0707apple020ｸ701090ｹ0 o ｷ307, ｷ apple ｧ ｧ apple020ｸ ﾑ80ｸ70306apple09 6ｾ ｧ80ｹ o o03o096ｧ9. 09 ﾇ 6ｾ46ｦ X 閨 apple 03o046ｧ8 apple030903o08o o0ｸ70ｹ ｧ90ｹ0. ﾆ ｧ ｸ ｧ9 09 apple 09fi03000ｸ ｹ ｧ ｹ0 020ｷ ｷ307 appleo0ｸ7 04o030909o6ｦ ｧ8 040ｸ ｧ ｸ700080ｷ ｧ9 apple ｧ ｦ ｧ ｹ apple030903o08fi ｹ0. 09 ﾇ 6ｾ46ｦ XIV 閨 ｦ0030ｸ ｹ0 6ﾑ ｷ304090ｹ ｨB ｧ9 07 apple ｧ ｹ0 6ｾ40ｸ707036ｧ802000ｹ0 閨 ｹ0 020ｷ 閨0ｷ307 ﾒ ｧ ｧ apple 03 閨 ｷ ｷ ｧ907o apple ｹ ｷ309 閨0ｹ0 applefi 02 ﾒ ｸ O06 06 apple ｦ ｹ0 appleo0ｸ7 閨04o0ｸ ｧ 閨 ｧ ｦ0apple02o0ｸ707 00fi07o oappleo6ｧ9 09 apple00036ｧ9o o0ｹ0 apple03o ｧ9 0ｹ ｹ0 apple07000ｸ ｧ80ｹ o ｧ9 0ｹ0 (apple 02 閨0702 ) ｹ0 0ｸ7applefi 閨 ｹ0 006ｧ o ｧ8 applefi 0ｸ7026ｧ8 appleo0ｸ ｦ ﾒ 閨 ｹ0 6ﾑ ｷ304090ｹ0. O06 0ｸ7applefi03o06apple000ｹ0 040ｸ ｹ0 08o03o6ｦ ｸ702o apple006ｧ9 (OTC) 6ｾ46ｦ V, ｦ00303 o ｧ804000ｷ30ｹ o0ｸ ｧ90ｹ0 6ｾ46ｦ I, apple 03 02o03o6ｦ ｷ ｷ ｸ70203o08o036ｧ9 02o0ｸ70ｹ0 (post marketing surveillance), 6ｾ46ｦ II apple 03o046ｧ ｧ80ｹ0 00apple0604o036ｧ ｹ0 (core- funding) 0400 o ｹ ｾ46ｦ III ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 21

22 13EFPIA ANNUAL MEETINGS ATHENS ｾ404 陦06o ｹ0 Commission 02090ｹ0 Commission H 閨 ｹ0 O0007 0ｹ o6ｦ0 6ﾑ8apple06apple 陦o0ｸ o02o006ｧ (G10) appleo ｧ9 00 閨03o0ｹ0 0007fi0ｹ0 000ｸ7036ｦ o0ｸ ｧ9o0ｸ ｹ0 Commission ｧ90ｷ ｹ ｷ fi ｹ ｹ ｸ ｧ80ｹ o ｧ9 0ｹ ﾑ80ｸ70306apple09. O06 08appleo0ｸ70309o6ｧ9 0806o ｧ9 0ｹ0 ｨB6ｧ applefi Commission 07 apple03o040ｷ3036ｧ 閨 ｷ ﾞ0106o03fi ｹ0 (Benchmarking indicators) 0304o0ｸ707 6ｧ o00o03o ｧ9 applefi Commission o ｧ80ｹ0 apple030ｷ302o6 5o0ｸ7036ｧ9000ｹ0: 09 6ｾ402060ｹ o ｧ9o0ｸ o 6ｾ40ｸ7006 5o6ｦ00306o 020ｷ307 08appleo0ｸ ｹ0 6ﾑ ｷ304090ｹ ﾞ ｷ fi ｸ706o03 閨 o 0404 陦06o ｹ0 appleo0ｸ7 0002applefi Commission ｸ7appleo04026ｧ ｹ0 0707apple020ｸ701090ｹ ｹ o o03o096ｧ9 0ｹ ﾑ80ｸ70306apple09 (Commission Communication on Life Sciences and Biotechnology in Europe). 09 ﾇ ｹ ｸ ｧ80ｹ0 07o00o ｧ9 0ｹ0-O06 apple03o ｹ ｹ0 Commission 040ｸ7ｨB0902o6ｦ o 6ﾑ80ｸ7030ｷ3apple 0ｸ802fi ﾒo0607o6 5o6ｦ00306o o 6ｾ40ｸ7006 5o6ｦ00306o 08appleo0ｸ ﾇ Commission 鐶pple 閨0209 G10 fi o070ｷ300 閨0709 apple030ｷ302o6 5o0ｸ7036ｧ 閨07 appleo fi forum ｦ ｷ 閨04000ｷ ｷ o00 閨070ｷ ｦ000080ｷ ｧ ｹ0 6ﾑ ｷ304090ｹ0 (Lisbon strategy). ﾞ0106o03fi ｹ0 EFPIA ﾞ0106o03fi ｹ0 EFPIA ﾇ EFPIA apple ｦ00006 fi o G10 appleo ｧ9 閨07 forum 040ｸ7ｨB09026ｧ804000ｷ o oappleo6ｧ9o o06 040ｸ 閨04o ｹ ｦ0o o 046ｦ007o03o 020ｷ ｸ ｷ307. O06 040ｸ ｹ0 0ｸ702 閨0ｹ appleo03o6ｦ o0403o6ｦ007 appleo04apple O06 040ｸ ｹ0 6ｧ9 o0ｸ707 閨 ｧ904040ｸ ｹ ｷ fi ｹ appleo03006ｧ o0ｸ707 02o apple o07 00 閨 o oappleo6ｧ9o o0ｸ ｧ o ｧ9. 縺 ｸ ｧ9 09 閨03000ｸ apple020ｸ 閨0ｷ ｷ307 apple ｧ apple03o ｧ ｹ0 apple07000ｸ ｧ80ｹ o ｧ9 0ｹ ｸ70203o08o036ｧ9 020ｷ 閨0ｷ ｷ fi ﾑ80ｸ7-0306apple apple03 鐶ppleo0ｸ ｧ8 (equitable price) 閨 fi000ｷ30ｹ0 02o 026ｦ00306o apple03fi , o fi0ｹ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ0 09o03070ｹ0 appleo0ｸ7 o ｧ9 0402o apple o 0000applefi0306o. ﾇ apple ｹ ｹ appleo0ｸ7 00o07o ｹ0 00apple o0ｸ707 ﾒ 閨 apple ｧ ｦ0030ｸ ｹ0 6ﾑ ｷ304090ｹ0. ﾇ ｷ fi ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｸ ｧ80ｹ0 0806o ｧ9 0ｹ ｸ703006ｧ9 00fi07o ｸ703o6ｦ apple03o6 5036ｧ appleo0ｸ o0ｸ ｧ ｧ8 appleo ｧ8 appleo0ｸ7 02o03o0ｸ703o6ｦ ﾑ ｷ ﾒ 閨 fi 00apple6ｧ9apple00 o. ﾇ 閨0209 G10 appleo ｧ9 閨 ｧ 閨030ｷ o ｧ80ｹ0 appleo ｧ80ｹ ﾑ80ｸ70306apple fi G10 G10 6ﾒ2o07 ｦﾐo6ｦ00706o o03006ｧ9 00 ﾞ07 02o6ｧ9070ｷ ｹ0 Commission03 (Communication) 09 oappleo6ｧ9 03 appleo ｧ apple6ｧ apple ｧ ｹ ｹ0 040ｸ ｹ0 G10. ﾇ EFPIA o6ｧ9070ｷ ｹ0 Commission o ｸ ｹ apple0703o0ｸ o03086ｧ8 apple 閨02030ｷ307 appleo0ｸ ｸ o0ｸ o0ｸ703096ｧ9 apple o0702o0ｹ0 appleo0ｸ ｸ707o006ｧ 閨03000ｸ ﾑ80ｸ70306apple09. 6ﾒ2o07 ｦﾐo6ｦ00306o Commission 03 o ｾ40ｸ707 陦0306o ｸ ｧ ｦﾐ ｧ8 0903o00 036ｧ ｷ300 閨07o 0402o G-10. ﾞapplefi o ｹ0 apple 03o0ｸ7046ｧ ｹ0 02o0ｸ7 6ﾑ8apple060203fiappleo0ｸ7 Liikanen, 6ｾ / ﾑ8apple ｷ ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

23 13 ﾞ070604fi ｹ fi ｷ307 6ﾑ80ｸ7030ｷ3 ﾞ070604fi ｹ fi ｷ307 6ﾑ80ｸ7030ｷ3apple 6ｧ90ｷ307 ﾞ 陦 陦 ﾞapplefi04apple 0400 applefi apple 03o0ｸ7046ｧ o0ｸ7 ﾞ070206apple03o 陦03o0ｸ ｹ0 EFPIA Jean-Fran04ois Dehecq Belgium Greece Portugal France Austria Finland Italy Norway Spain Netherlands Switzerland Sweden Denmark Ireland UK ﾒ ﾞ05086ｾ46ﾒ26ﾑ806 ﾇ6ｾ4 ﾇ ﾞ09O 6ﾒ2 ﾇ03 ﾇ096ﾑ806O09 ﾇ03ｦﾐ ﾞ ﾞｦﾐ6ﾒ2 ﾇ6ｾ4 ﾇ6ｾ4 罔ﾐ ﾞ ﾒ ﾞ05O06ｦﾐ6ｾ409O 6ﾒ2ｦﾐ09 ﾇ6ｾ4 096ﾑ80106ｦﾐ 6ﾒ2 ﾇ03 6ﾑ8036ﾒ2 ﾞ6ｦ1 ﾇ 6ｾ46ﾒ2 ﾇ ｦﾐ6ｾ46ﾒ2 ﾞ 90 days 180 days 100 Prising P&R Reimbursement Publication ﾇ 0ｸ709006ｧ 閨 ｧ 閨 fi0402o0ｹ003, o ﾞ070206apple03fi00 03o0ｹ ｹ0 EFPIA Jean- Francois Dehecq. ﾇ 016ｧ ｹ apple006ｧ9 0ｹ o0602o07o 閨 applefi 02o appleo02 閨 ﾇ 016ｧ9 03o06applefi07 apple03o o o ｸ70008 閨03o ｷ o00 閨070ｷ O ｧ90ｹ0 03 閨03o0ｸ 閨04o0ｸ ｧ8 02o0ｸ70ｹ ｦ ｹ apple006ｧ9000ｹ0, o06 oappleo6ｧ9000ｹ0 03 apple ｧ907o0ｸ ｨB0ｷ36ｧ8 02o0ｸ70ｹ o0ｸ70ｹ ｧ9ｨBo0ｸ ｦ appleo06fi ｨB0ｷ36ｧ80ｹ0. 縺06 02o 03fi09o 0ｸ702fi 閨03o fi03o apple fi020003o ｸ 閨04o0ｸ ｧ appleo ｷ ｸ o07o ｧ8 apple00036ｧ appleo 閨04o apple o036ｧ8 apple appleo0ｸ7 0ｸ706o030002o6ｦ007 o06 020ｸ ｧ ｹ0. ﾇ 閨03000ｸ ｧ fi apple03fi ｷ 陦 apple appleo 6ｧ9ｨB applefi 02060ｹ ｸ ｧ ｹ 閨 , 0402o o fi ｧ80ｹ ｸ applefi o06070ｷ ｧ O ｧ90ｹ0 03 閨03o0ｸ ｸ704026ｧ o06070ｷ ｧ80ｹ ｹ appleo02036ｧ907o ｹ ｹ0 02o0ｸ70ｹ0. ﾇ ｧ9 09o ｷ 閨 apple ｸ ｧ ｸ7apple0ｷ ｧ8 0707apple020ｸ o0ｸ7 apple ｧ803o0ｸ7 0000appleo036ｧ9o0ｸ7 appleo 0ｸ ｷ ｷ fi ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｸ ｧ80ｹ0 0806o ｧ9 0ｹ0 040ｷ3036ｧ90ｹ0 07 apple 03 閨 apple0300o ｧ o0ｸ70ｹ ｧ90ｹ ｷ o ｧ90ｹ ﾑ apple0ｷ o6ｦ fi 閨04o0ｸ fi ｧ ﾑ80ｸ70306apple09. 6ｾ apple fi000ｷ30ｹ0 o06 07 閨000ｹ apple006ｧ9000ｹ o0ｸ ﾑ ｧ807000ｹ0 0309fi 閨 ﾞ ｧ9 6ｧ 縺 ｧ9. 6ﾑ8apple6ｧ9 apple03 鑰07 03fi090ｷ3 020ｷ307 apple ｧ8030ｷ ｷ o ｹ ｧ90ｹ o6ｦ 陦 apple0006 6ｧ o 閨07 applefi 0ｸ 閨 o 90% 00apple applefi ｨBo ｹ ﾒ 閨0309 appleo0ｸ7 閨04o0ｸ707 0ｸ fi ｧ8. 6ｾ402o apple o07 0ｸ702fi ｸ ｧ o ｧ ｦ007090ｹ0 apple 03006ｦ appleo ｧ ｷ fi ｹ0. O 閨0ｹ0 020ｷ ｷ o036ｧ9ｨBo fi ｧ ｹ0 6ﾑ80ｸ70306apple090ｹ0, appleo0ｸ7 006ｧ ｧ8 046ｧ , o0ｸ ｧ o0ｸ ｧ8 6ｦ00306o. ﾇ ｸ7026ｧ8 006ｧ appleo0ｸ7046ｧ oapple03fi o0ｸ7 o o0ｹ ｸ ｧ o ｧ ﾑ80ｸ70306apple09. O06 040ｸ ｹ0 02o0ｸ7 G-10* ｧ ｦ VI 6ｧ907o0ｸ appleo apple6ｧ appleo03006ｧ ｸ o0ｸ o0ｸ ｧ ｦ o0ｸ7 apple o0702o0ｹ0 appleo0ｸ apple 閨 o0ｸ70ｹ ｧ90ｹ 閨6 7o0ｸ ｧ809o03 02o0ｸ70ｹ appleo6ｦ00ｹ ｹ ｸ ｧ80ｹ0 閨03000ｸ707 0ｹ0. ﾇ 6ｾ46ｦ VI 02o0ｸ7 G 閨 ﾇ 6ｾ46ｦ VI 02o0ｸ7 G 閨 ｧ80ｹ0: 00 ﾇ 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ8 6ﾑ8apple060203oapple6ｧ8 (Commission) ﾒ 閨0309 apple03 鐶pple ｧ904o0ｸ ｧ8 fi o 06fi ｷ307 ﾒ ｸ703006ｧ9ｨBo0ｸ ｹ 閨0ｹ0, 08o fi07o appleo0ｸ ｦ0apple02o applefi o06070ｷ ｧ 縺 appleo0ｸ ｦ0apple02o applefi o06070ｷ ｧ ｧ ｧ applefi ｷ 閨0ｹ0 09o03 閨0ｹ0 apple03 鐶pple apple 鐶pple o ｦ o0ｹ ｷ fi0ｹ003. ﾇ 6ﾑ80ｸ70306apple ｹ ｧ9 0ｹ 閨 ｧ ｧ9appleo0200 appleo 0ｸ o0702 0ｹ ｸ ｧ o ｧ9. 6ﾑ 閨03000ｸ 陦 appleo0ｸ7 096ｧ ﾑ80ｸ70306apple09 appleo 0ｸ ｷ303006ｧ9 02fi0009 apple fi020003o 09 6ﾑ80ｸ70306apple fi apple6ｧ9apple00 : 05 appleo 0ｸ ｷ303006ｧ9 09 apple 0404fi , o06 o0602o07o 閨0ｹ fi ｹ 閨03o0ｹ ｧ8 o0602o07o006ｧ9. ﾞapplefi o0409 6ｾ / ﾑ8apple ｷ ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 23

24 13EFPIA ANNUAL MEETINGS ATHENS ｷ3applefi "MEDICINES FOR MANKIND" apple apple fi fi0706 apple030607, ｧ ｧ8 00 0ｹ ｹ ｧ9000ｹ0 020ｷ ｧ o07 apple000306o 閨0709. ﾇ applefi ｹ o6ｦ00ｹ0 00apple o ｧ80ｹ0 02o0607fi ｹ ｸ ｧ ｦ o0ｸ70ｹ o6ｦ00ｹ0 appleo0ｸ7 00apple ｨBo0ｸ o03o096ｧ9 02o0ｸ appleo0ｸ7, 020ｷ307 ｨB060ｷ ｷ oo , 閨 ｸ 閨 ｸ702 6ｧ9 0403fi0706, 00 閨040ｷ3 apple03o ｷ307 fiapple0ｷ30ｹ o o0ｸ7 09o o0ｹ0, apple 03046ｧ8 0ｸ702o6ｦ0 appleo0ｸ7 o07o0007ｨbo0ｸ o ｧ8 00apple ﾒ appleo0ｸ7 020ｸ70203o08fi ｸ702 6ｧ fi ｧ9ｨBo apple ｧ ｹ0 00o ｧ80ｹ o03o096ｧ9 0ｹ0 00 閨040ｷ ｹ0 oappleo6ｧ9 0ｹ0 o06 00apple ｧ800o07000ｹ ｧ fiappleo0ｸ70ｹ ｧ903o0ｸ707 6ｧ8 07 apple appleo 6ｧ904o0ｸ ｸ apple 03 09fi07020ｷ307 appleo0ｸ7 0000apple03 閨02o o ｹ0 07fi04o0ｸ7, fiapple0ｷ30ｹ0 o06 6ｧ9 0ｸ703o06 06fi07020ｷ307, o06 0ｸ7appleo o04006ｧ90ｹ0, 6ｧ8 02 閨07ｨB0ｸ700. ﾇ 0ｸ7096ｧ8 02o0ｸ7 21o0ｸ apple 03o0ｸ ｨB0006 閨 ｹ0 07 鑰 02oapple6ｧ9o ｹ ｧ ｹ ｹ o ｧ80ｹ0 6ｧ8 02fi fi020003, 02090ｹ0 apple030ｷ30200o ｧ80ｹ0 ( oappleo6ｧ9 apple03o04apple 03o6ｦ o6ｧ804o0ｸ ｦ ｹ o0ｸ703096ｧ9000ｹ0 020ｷ307 apple030ｷ302000ｸ ). ﾇ ｧ8 0ｸ7026ｧ8 00 0ｹ0 apple03o0408 閨 ｹ o6ｦ00306 apple03o04 閨 閨 ｹ0 02o0ｸ7 07 apple020ｸ70900 閨07o0ｸ7 6ｧ8 02o0ｸ7 0ｸ7applefi 0707apple020ｸ fi0400o0ｸ , ｧ ｹ o o03o096ｧ9 o 0909o6ｦ appleo0ｸ7 0402o04006ｦ0o0ｸ ｦ ｧ ｦ ｹ o0ｸ703096ｧ9000ｹ0 appleo0ｸ7 00apple ｨBo0ｸ 閨 ｷ307 07o ｷ307. 6ﾒ2o6ｦ002o 閨 ｷ30ｹ0 appleo02 閨 o0ｸ703096ｧ ｸ70203o08o036ｧ o036ｧ90ｷ 閨 ｹ ｷ3apple06ｨBfi ｹ0 00 閨 ｧ ﾇ 07 陦 0ｸ7026ｧ8 00apple ｧ ｷ o036ｧ90ｷ apple000ｸ ｧ ｧ ｧ ｹ o ｧ8 applefi apple 03 o ｧ8 00 閨 ｧ ｧ ｷ o036ｧ90ｷ apple03o086ｦ ﾇ ｸ apple020ｸ 閨0ｷ ｷ ｧ apple00036ｧ9apple03o ｧ9. ﾒ 07o , ｧ9 apple fi020003o applefi fi0706 applefi ｧ ｹ ｸ ｹ0 02o0ｸ7 07 鑰0ｸ7 00o036ｧ9o0ｸ7 00 閨 ｸ70203o08o036ｧ9 02o0ｸ7 07 鑰0ｸ o0ｸ7. ﾇ ｧ9 apple apple ｷ o026ｧ8020ｷ307 apple03o 閨07o0ｸ ｧ9 fi o 07 鑰 00fi0306o appleo0ｸ ｦ apple 03 閨 apple 03026ｧ appleo fi 閨 ｹ 閨 ｹ0 appleo0ｸ7 apple03oo036ｧ9ｨb apple006ｦ appleo ｧ9 apple ｸ ﾞ02fi applefi 閨 o0ｸ7 07 鑰0ｸ o0ｸ7, 09 閨03000ｸ ｸ ｧ appleo fi o0ｸ7 07 鑰0ｸ 閨07o0ｸ o0ｸ ｸ7036ｦ o0ｸ70ｹ0 apple ｸ70400o6ｦ00ｹ ﾇ fi fi 閨 ｸ fi02 02o 02fi0402o0ｹ0, apple fi020003o applefi o00006ｦ appleo0303 閨0ｹ0 08o03 閨0ｹ o o00006ｦ00306o, 00 閨 o 07 鑰 o ｧ o0ｸ o6ｦ00ｹ ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

25 136ﾒ2 00apple ｦ ｹ ｸ ｧ80ｹ0 閨03000ｸ707 0ｹ0 apple 03080ｸ ｨB ｸ7036ｦ fi ｸ ｧ ｹ ｹ0 00apple ｧ9o0ｸ7 ( ) applefi 02090ｹ ｦ004000ｷ30ｹ ｹ0 EFPIA (European Federation of Pharmaceutical Industries and Association) apple 03o0ｸ ｧ8 閨 oappleo6ｧ9 apple03fi 閨 fi ﾑ80ｸ70306apple09 apple03o 閨07o0ｸ ｧ o08 閨 ｹ0 apple03ooapple 閨0ｹ ｹ0 apple030ｷ302oappleo ｧ80ｹ ｸ ｧ80ｹ0 閨03000ｸ707 0ｹ0. ﾇ 閨 ﾞ ｷ3applefi apple03o fi ｸ o ｹ ｸ ｧ80ｹ0 閨03000ｸ707 0ｹ ｧ8 apple03fio o apple 03o0ｸ ｨBo0702 0ｹ appleo03036ｧ8 046ｦ00702o o006ｧ apple ｦ ｹ0 閨03000ｸ707 0ｹ apple00036ｧ9appleo0ｸ apple000ｸ o6ｦ00ｹ0 02o00006ｧ90ｹ0. ﾇ 閨 閨 apple ｦ o0ｸ7 apple fi0702o0ｹ , ｹ0 000ｸ ｧ9000ｹ0 02o0ｸ7 00 閨0303o0702o0ｹ 陦 appleo0ｸ ｸ 閨04o0ｸ fi ｦ ｧ90ｷ ｹ0 0ｸ709006ｧ9 0ｹ ｹ0 000ｸ ｧ9 0ｹ0 02o0ｸ appleo0ｸ , 0402 apple03 6ｧ ｹ0 EFPIA o0ｸ ｧ9 09 O ｷ ｸ7030ｸ ｸ707 0ｹ0 (Research Directors Group ｨC RDG). H RDG 006ｧ o0007 0ｸ o6ｦ0 00apple06apple 陦o0ｸ 閨00 02 閨03000ｸ707 0ｹ0, appleo0ｸ ｨBo ｹ ｧ9000ｹ0-00 閨 ｹ0 EFPIA ｧ ｧ 閨0409 appleo0ｸ7 006ｧ ｸ7apple006ｦ0030ｸ ｸ ﾞ0707apple020ｸ ｷ ｸ apple03o0ｸ8fi07020ｷ apple000306o046ｧ ｹ0 6ﾑ80ｸ70306apple090ｹ0. O 0402oapplefi0ｹ ｹ0 RDG 006ｧ ｧ appleo0ｸ7 06fi ｹ0 閨03000ｸ707 0ｹ ｸ ｧ o ｧ ｧ fi0206 o06 applefi ｹ ｹ o6 506o ｧ9 0ｹ o ｸ7applefi ｹ0 040ｸ7ｨB09026ｧ ｹ apple03o 090ｷ3096ｧ ｹ ｷ fi ｹ ｹ0 6ﾑ80ｸ70306apple090ｹ0 0402o07 02o00 陦 02090ｹ o0ｸ ｧ80ｹ0/ ｸ ｧ80ｹ ｸ707 0ｹ0. O o fi04o ｹ0 RDG 閨04o0ｸ ｧ apple ｸ ｹ0 o0007 0ｹ ｹ o0ｸ7 036ｧ9o0ｸ o0002o ｧ9 apple030903o08o o6ｦ0 0ｸ o6ｦ0/0002apple ｸ ｸ ｧ90ｷ307. 6ｾ402fi04o0ｹ0 02o0ｸ7 0ｸ o6ｦ0 0ｸ702o6ｦ0 006ｧ ｧ ｧ ｹ ｸ ｧ80ｹ0 閨03000ｸ707 0ｹ0 & apple020ｸ701090ｹ ﾑ80ｸ70306apple apple 03o0ｸ o6ｦ 陦 appleo0ｸ ｧ /020ｸ70203o08fi ﾑ80ｸ70306apple09 02o 2001/ ﾑ8apple6ｧ904090ｹ0, 03 apple ｧ apple03fi 0203fiappleo 02o 09060ｹ0 ﾞ ｦ0apple02o ﾞ07 apple026ｦ00404o o0002o ｧ9 "Position Papers" ｧ ｷ ｹ0 EFPIA/EBE/EVM ｨB09026ｧ fiapple0ｷ30ｹ0 09 閨03000ｸ apple fiｨB0ｷ3, o06 07 閨000ｹ o03o096ｧ9000ｹ0 fiapple0ｷ30ｹ0 02o010602o090007o ｧ o ｧ ｹ ｸ ｧ8 閨03000ｸ707 & 0707apple020ｸ ﾑ8apple0602o06070ｷ3076ｧ ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ8 6ﾑ8apple060203oapple6ｧ ｧ8 applefi6 7000ｷ oapplefi apple020ｸ ｦ0o0ｸ7 02 閨 ｷ307 ﾞ ｧ9 0ｹ ﾑ80ｸ70306apple09, ｹ o fi ｹ ｸ ｧ80ｹ o ｧ9 0ｹ ｨB09026ｧ ﾑ8apple ｧ9 0ｹ fi00 03o0ｹ ｹ0 RDG 006ｧ o ﾒ ｧ80ｹ0 6ﾒ2revor Jones, 縺 fi0ｹ0 04/ ｹ0 02o0ｸ o6ｦ0 6ｾ40ｸ707 閨0400o0ｸ ｸ ｧ80ｹ0 0806o ｧ9 0ｹ0 (ABPI). 6ﾒ2 00apple ｦ o0ｸ7 apple fi0702o0ｹ o ｧ ｹ ｹ0 00apple ｧ800090ｹ0 appleo0ｸ7 040ｸ o6ｦ ｸ702 6ｧ9 0403fi0706 閨04o0ｸ ｸ7036ｧ apple020ｸ o0ｸ o6ｦ0 07 閨0ｷ ｷ307, apple06o 閨070ｷ307, 02fi04o 0ｷ30ｹ0 apple03o0ｹ ｧ902000ｸ70409 fi04o ｷ30ｹ0 apple03o0ｹ appleo fi ﾇ ｸ ﾞ0707apple020ｸ ｸ ｧ904o0ｸ ｧ90404o , ｹ0 07 閨000ｹ0 apple03o02036ｧ ｹ ｧ9ｨBo , fiapple0ｷ30ｹ0 apple03fi o SARS (04o6 5 03fi o016ｦ0 07 apple07000ｸ fi 046ｦ007 03o00o). ﾇ ｸ ｧ8 閨03000ｸ apple03fi ｧ , 6ｧ8 fiapple0ｷ30ｹ0 006ｧ9apple00 o Prof. Trevor Jones "we cannot stop now". ﾇ ｸ ｧ8 0806o ｧ9 006ｧ apple03o o 閨 ｸ 閨0ｷ307 appleo fi ｷ307, 閨 ｷ fiapple ｷ ｷ ｸ7apple ｧ ｹ0 0ｸ709006ｧ9 0ｹ ｸ ｧ9 0ｹ ｹ ｷ3applefi ｹ0. ﾞapplefi : ﾞ ｧ apple 030ｷ / ｦﾐ ｦ0 6ﾒ2006ｧ ｹ0, Janssen-Cilag ｸ ｧ8 ﾞ6ﾑ8086ﾑ ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 25

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29 13006ﾒ fi apple ｦ ｸ ｸ ｧ8 apple00036ｧ ｹ0 0ｸ7applefi 閨 ｹ003, ｧ9ｨB ﾑ8FPIA ﾒ ｹ0 縺 ｧ80ｹ0 6ｾ40ｸ707 閨03000ｸ704090ｹ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8-026ｧ80ｹ0 O00o04appleo07 6ｧ9 0ｹ ｸ ﾑ8apple ｧ804000ｷ ｾ40ｸ707 閨04000ｷ307 (EFPIA) appleo0ｸ7 apple oappleo066ｧ ﾞ036ｧ ｹ ｧ9o0ｸ7 2003, 06o workshop 閨 ｦ0030ｸ ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｷ304090ｹ0: 09 03o046ｧ8 08apple ｧ9 0ｹ ﾑ80ｸ70306apple09 02o ｾ402o workshop 040ｸ ｧ apple fi020003o06 applefi ｦ o06, 0300fi 06o o fi appleo ｧ80ｹ ｹ0 0ｸ709006ｧ9 0ｹ0 020ｷ307 0ｸ7applefi 閨 ｷ ｹ o apple03fi040ｷ3appleo ｹ ｸ ｧ80ｹ o ｧ9 0ｹ o o07fi0ｹ0 fi ｦ0030ｸ ｹ0 6ﾑ8.6ﾑ 閨 apple oappleo ｧ9 046ｦ00702o00 - 閨 ｹ o6ｦ ｹ1o0ｸ ｨC o Brian Ager, 縺 fi0ｹ ｸ7030ｸ707026ｧ80ｹ ｹ0 EFPIA, 0ｸ7appleo fi0206 o06 0ｸ7applefi 閨 ｹ ｷ3apple6ｧ9ｨBo0ｸ707 02fi0009 appleo036ｦ apple03o6 5036ｧ apple 03o046ｧ o ｸ ｧ80ｹ0 apple00036ｧ ｹ fi apple 0602o6ｦ standards 閨04o0ｸ707 appleo 閨 閨03o0ｹ0 020ｷ apple ｦ004000ｷ ｹ0 閨 ｹ0, 06fi0206 o06 040ｸ7ｨB09026ｧ ｹ0 閨04o0ｸ707 00apple ｷ303006ｧ9 00fi07o fi ｷ307 0ｸ7appleo6 76ｧ ｷ ｷ fi04o0ｸ707 02o 02o0607o020602fi 閨07o. 6ｾ402o workshop ｸ7ｨB6ｧ apple ｨB09026ｧ800-02, appleo0ｸ7 閨04o0ｸ ｦ ｧ o0ｸ70ｹ0 appleo036ｧ902000ｹ0 020ｷ 閨0ｷ : ｦ ｷ o ｸ ｧ80ｹ0 apple00036ｧ ｹ0 0402o07 02o00 陦 02090ｹ0 0900fi0406 0ｹ0 0ｸ709006ｧ9 0ｹ0, ｦ ｷ ｸ ｷ307 0ｸ709006ｧ9 0ｹ0, ｸ ｷ ｹ0 040ｸ o046ｧ80ｹ0 020ｷ o0ｸ7 03fi03o0ｸ ｹ0 6ﾑ8.6ﾑ8. 6ｾ46ｦ000080ｷ apple03fi 閨 ｹ0 6ﾑ8apple060203oapple6ｧ80ｹ0 apple03o6 503 鐶pple fi 陦 00 閨0309 6ｧ9040ｷ30ｹ o6ｦ fi ｦ06 7o0ｸ o ｸ7apple070304o 閨 fi04o fi04o07 08o o ﾞ6ﾑ809 fi04o ｹ0 00apple0007 6ｦ ｹ apple 03o046ｧ o ｸ ｧ80ｹ0 apple00036ｧ ｹ0. O 02. Ager ｷ3026ｧ appleo03o6ｦ ｧ907o0ｸ707 apple fi020003, ｸ7030ｷ303006ｧ9 02o o07 02o00 陦 02090ｹ0 0ｸ709006ｧ9 0ｹ0. ﾞ fi000007o0ｹ , appleo0ｸ7 apple ｧ apple03fi o 閨07000ｹ0 0ｸ7applefi 閨 ｹ apple o036ｧ8 020ｷ307 apple ｸ709006ｧ9 0ｹ0, o Friedrich Breitenstein, 0903fi00 03o0ｹ ｹ0 O0007 0ｹ ｹ ｹ0 EFPIA ｦ0030ｸ , 02fi fi ｦ ｷ307 00apple0007 6ｦ004000ｷ o ｸ ｧ8 apple00036ｧ ｧ ｹ oapple03fi apple06020ｸ7046ｧ ｹ ｦ0030ｸ ｹ ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 29

30 13EFPIA ANNUAL MEETINGS ATHENS ｧ ｦ0030ｸ fi03o0ｹ ｹ ｸ ｧ80ｹ o ｧ9 0ｹ0 05 apple03 鐶pple ｧ 閨0ｹ0 fi o02fi appleo03o6ｦ apple 6ｧ901o0ｸ fi 03fi03o ｧ90ｷ ｹ0 appleo06fi ｹ ｹ0 appleo fi ｹ0 020ｷ307 0ｸ7apple ｹ0 apple 03o046ｧ80ｹ0 0ｸ709006ｧ9 0ｹ ｹ ｸ707o ｧ8 02o06070ｷ ｧ8 000ｸ ｧ9. 006ｾ40ｸ70700apple060ｹ0, apple03o fi ｹ0 006ｧ ｷ ｧ ｸ ｧ o ｧ9 閨03000ｸ707 0ｹ0 0ｷ30ｹ0 040ｸ ｧ80ｹ apple 03o046ｧ8 0ｸ7apple ｸ709006ｧ9 0ｹ ｸ7030ｸ7-00 閨0709 6ﾑ80ｸ70306apple0903, 006ｧ9apple00 o 02. Breitenstein. 00 ﾇ 00apple06020ｸ7046ｧ9 02o0ｸ ｧ9o0ｸ ｦ0030ｸ ｹ ｹ0 6ﾑ80ｸ70306apple090ｹ0 0402o ｸ fi 02o00 陦 ｧ9 applefi ｹ fi ｹ0 020ｷ o02fi000ｷ ｷ ｹ0 07 閨000ｹ0 0ｸ7applefi 閨 ｹ0, 040ｷ3036ｧ90ｹ o6ｦ 閨 fi ｷ307 6ﾑ80ｸ7030ｷ3apple 0ｸ , appleo0ｸ ｧ9ｨBo 閨03000ｸ ｧ8030ｷ30400 o 02. Breitenstein 閨02o0ｸ o0ｸ70ｹ0 026ｦ00306o0ｸ70ｹ0 0701o07000ｹ0 02o0ｸ7 apple03o o6ｦ0 appleo0ｸ7 07 apple026ｦ : 09 ﾇ appleo0ｸ7046ｧ9 030ｸ703006ｧ904000ｷ ｸ709006ｧ9 0ｷ30ｹ0 閨 ｷ fi ｨB6ｧ apple03060ｹ o o07fi0ｹ0 fi ｸ709006ｧ ｷ303006ｧ apple000306o046ｧ ｧ80ｹ0 appleo ｧ80ｹ fi04o, ｧ ｸ 閨 ｦ0030ｸ ｹ0 6ﾑ8.6ﾑ8., 03 閨 ｸ707o 閨 ｸ709006ｧ9 0ｹ0 fi04o ｧ ｦ0030ｸ o apple fi ﾞ0700apple06036ｦ ｹ 閨 ｹ ｹ ｧ80ｹ0 apple000306fi o0ｸ7 04 ｯ 0ｸ702 閨0ｹ ｹ0 02o06070ｷ3076ｧ9000ｹ0 006ｧ o0602o07o ｧ ｧ90409, 02o06070ｷ 閨0ｹ fi ｹ0, 06006ｦ0030ｸ ｷ o o 6ｧ800 02o0ｹ0, fi0ｹ fi0ｹ ｧ9 0ｹ fi ﾒ2o o07fi0ｹ0 fi0206 o ｹ ｹ0 6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ ｷ304090ｹ ｧ90402o ｸ7026ｧ ｧ 閨040ｷ3 00apple fi03080ｷ ｹ0 020ｷ o0ｸ70ｹ0 040ｸ ｷ307 0ｸ709006ｧ9 0ｹ apple 鐶pple0006 apple036ｧ o fi0ｹ0 apple03o026ｦ0appleo0ｸ o0ｸ o096ｧ fi o0702 閨 ﾇ 0ｸ709006ｧ apple03o040ｷ3apple006ｦ00006 apple00036ｧ9appleo0ｸ7 02o 4,5% 02o0ｸ7 ﾞ6ﾑ ｹ0 0ｸ7applefi 閨 ｹ o 06apple o 0ｸ702o6ｦ0 02o0ｸ7 appleo04o0402o6ｦ ｹ0 apple fi ｹ ｹ0 09 閨 applefi apple03o00applefi , fi0206 o06 apple 03o04 閨0ｹ appleo03 閨04o0ｸ appleo o6ｦ ｹ0 0ｸ701 07fi ｹ0 apple 06026ｧ ｹ0, o 02o00 陦 0ｹ0 0ｸ7apple ｸ709006ｧ9 0ｹ 閨 閨 ｸ70300o6ｦ00ｹ0 0707apple020ｸ701090ｹ ｷ3 02o0ｸ7 00 閨04o0ｸ7 fi03o0ｸ fi04o 02 02o07 6ｦ00306 appleo0ｸ ｧ applefi 02o 0900fi0406o 02o00 陦 ｧ apple000306o 閨 apple ｧ applefi030ｸ ｷ307 applefi030ｷ ﾒ2o fi ｦ o o016ｧ9 0ｹ apple fi ｹ0 02fi04o 02o06070ｷ fi04o appleo ｧ fi fi04o07 08o ﾞ07 02o ｧ ｦ0030ｸ ﾒ2o 07 apple ｧ90ｹ ｧ o apple03fi ｧ fi ｦ fi04o, 00appleo03o6ｦ o o020903o6ｦ007 apple03o apple0600fi03080ｷ304090ｹ ｧ907o0ｸ707 00apple0007 6ｦ ｹ ｧ ｧ ｷ ｧ8 o006ｧ8, apple ｸ o0702 0ｹ0 02oapple0602o6ｦ00ｹ0 applefi03o0ｸ70ｹ apple ｷ3006ｧ ｷ300 閨070ｷ o ｧ90ｷ307. 6ｾ402060ｹ0 apple03o0909o6ｦ ｹ ｸ7036ｦ ｹ ｹ0 6ﾑ86ﾑ o fi ｹ0 046ｦ ｹ0 0402fi04000ｸ ｹ o03 閨0ｹ o apple o apple03 鐶pple0006 6ｧ9040ｷ30ｹ o6ｦ ｸ709006ｧ9 03 閨 ｧ8 fi apple6ｧ oappleo03 閨 apple o07 0ｸ7036ｧ90ｷ307. ﾞapplefi 閨07080ｸ Head of Regulatory Affairs Pfizer Hellas 30 6ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

31 13096ｧ8070ｸ700 applefi 0208 縺 fi 04/07026ｧ8 096ｧ8070ｸ700 applefi 0208 縺 fi 04/07026ｧ ｹ0 EFPIA 02. Brian Ager ﾞ036ｧ ｹ1080ｸ ｹ1080ｸ ｸ ｧ ｹ0 EFPIA 02. Brian Ager ﾞ036ｧ ｹ1080ｸ ｹ1080ｸ ｸ ｧ90708 ﾞapplefi ｸ 閨07080ｸ7 6ｾ / ﾑ8apple ｷ307 ﾇ 縺 ｧ8 6ｾ40ｸ707 閨03000ｸ ｹ0 EFPIA ﾞ036ｧ807 陦0ｷ ｸ ｧ ｸ7apple006ｦ0030ｸ707o0ｸ70ｹ0 036ｧ ｹ0 appleo ｷ o6ｦ00ｹ o0ｸ70309o6ｦ00ｹ0, 0002apple03o0406appleo0ｸ70ｹ0 020ｷ , ｸ802o6ｦ00ｹ0, 0900o0406o o0ｸ70ｹ 閨 ｹ ｸ ｧ80ｹ o ｧ9 0ｹ ｦ007090ｹ ｸ o6ｦ o0ｸ707 applefi ｹ apple ｷ ｸ ｧ9 02o0ｸ7 00o o6ｦ0 020ｷ fi070ｷ307 applefi ｧ9 030ｸ ｹ0 EFPIA o0ｸ7 ﾞ apple06o6ｦ0, 02090ｹ ｧ9 0ｹ o0ｸ7 ｦﾐappleappleo 閨 apple ｦ fi070ｷ307 閨03000ｸ707 0ｹ ｸ 閨0ｷ ｷ ｹ0 000ｸ ｧ9000ｹ apple 閨030ｷ3 0707apple020ｸ ｷ ｷ3applefi O06 040ｸ707036ｧ802000ｹ0 6ｧ ｹ ｨB0ｷ 閨0ｹ0 040ｸ7ｨB09026ｧ ｹ ｹ ｧ o ｧ o fi fi. 6ﾑ8apple0603 閨 ｷ30ｹ0 03 閨00 02o0ｸ7 040ｸ ｧ9o0ｸ ﾑ80ｸ70306apple ｹ ｧ9 0ｹ ｦ000080ｷ o 07026ｧ90402o0604o apple03fi ｹ0 Commission o ｾ402 workshops o 040ｸ707 陦0306o 閨 ｸ ｷ307 apple03o ｷ307 appleo0ｸ7 0ｸ7apple070304o0ｸ apple03fi ｷ 陦 fi ｹ0 02o06070ｷ3076ｧ9 0ｹ0 07 apple 03 閨 ｧ904000ｹ0 000ｸ ｧ9000ｹ0 apple03fi ｹ ｹ0 0ｸ7apple ｧ9000ｹ ｧ9 0ｹ fi03o0ｸ70ｹ0 02o0ｸ70ｹ ｧ90ｹ0. 6ﾒ2 00 閨 ｹ0 EFPIA 006ｧ ｸ ｧ ｸ o0ｸ ｹ0 040ｸ7ｨB09026ｧ ｹ0. 05 閨030ｷ ｸ ｧ8040ｷ3 02o07 6ｾ4026ﾑ86ﾑ ｧ8 0ｸ7appleo o046ｧ8 appleo0ｸ7 00 0ｹ0 00apple00086ｦ ｧ8 040ｸ7006 5o036ｧ8 02o0ｸ o ｷ ｹ ｧ8030ｷ304090ｹ ｹ0 07 閨0303o0ｸ o 036ｧ90207o 02o0ｸ7 6ﾑ80ｸ7030ｷ3apple 0ｸ802o6ｦ0 09o o6ｦ0. ﾒo ｹ0 0402o 00 閨0303o ｧ ｹ o ｷ3 fi 縺 ｧ8 6ｾ40ｸ707 閨03000ｸ ｹ0 EFPIA o ｧ ｧ9o0ｸ7 0402o 04o0ｸ ｧ907o ｸ ｧ IPHA, 02o07 ｦﾐ fi 6ｾ46ｦ o ｸ ｧ80ｹ0 0806o ｧ9 0ｹ ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 31

32 13EFPIA ANNUAL MEETINGS ATHENS ｦ ｹ0 ﾞ0609 6ｧ9080ｸ ｸ70ｹ003 ﾞ036ｧ807, ｹ1o0ｸ ｨC 00036ｦ ｹ0 02o0ｸ7 ﾞ0609 6ｧ9o0ｸ o0ｸ70ｹ003 險B apple fi020003o06 applefi 500 6ﾑ80ｸ7030ｷ3apple 6ｧ9o fi00 03o06, 縺 o6ｧ ｸ7030ｸ70702 閨0ｹ 閨 ｷ ｦ ｷ ｸ apple ｧ804000ｷ ｾ40ｸ707 閨04000ｷ ｹ0 6ﾑ80ｸ70306apple090ｹ0 appleo o0702 0ｹ 閨 appleo0ｸ7 apple03o04 閨 o 6ｾ4026ﾑ86ﾑ applefi 6ﾑ H ｧ8030ｷ30409 apple oappleo066ｧ o03006ｧ fi ｧ ｸ o0ｸ ｸ o6ｦ o0ｸ ﾑ80ｸ70306apple09, appleo0ｸ o01 閨 apple03fi apple o ｹ0: 縺 ｧ8 6ｾ40ｸ707 閨03000ｸ ｹ0 EFPIA (6ﾑ80ｸ7030ｷ3apple 0ｸ8026ｧ80ｹ0 O00o04appleo07 6ｧ9 0ｹ0 6ｾ40ｸ707 閨04000ｷ ｸ ﾑ8apple ｧ804000ｷ307) 09 oappleo6ｧ9 06o ｸ ｧ o07 6ｾ46ｦ o ｸ ﾑ8apple ｧ804000ｷ307 6ﾑ o0ｹ0 (6ｾ4.02.6ﾑ8.6ﾑ8.). O 0903fi00 03o0ｹ0 02o0ｸ7 6ｾ4026ﾑ86ﾑ8 02. 縺 o0ｹ0 6ｾ40ｸ ｹ ｷ304fi o0ｸ70ｹ0 apple 03000ｸ o00 閨07o0ｸ70ｹ ｸ ｧ ｧ o fi00 03o o 04.6ｾ ｹ0 EFPIA appleo0ｸ7 apple oappleo6ｧ ﾑ ﾑ8026ｧ80406 縺 ｧ8 6ｾ40ｸ707 閨03000ｸ7046ｧ8 02o0ｸ70ｹ0. 08apple006ｦ0030ｸ707o0ｹ fi04o 00apple06020ｸ 閨 o ｷ ｹ ｹ0 6ｧ o ﾞ070206apple03fi00 03o0ｹ0 02o0ｸ7 6ｾ4026ﾑ86ﾑ ｾ4apple6ｦ003o0ｹ ｹ0. 6ﾒ ｧ apple 03o0ｸ7046ｧ9 02o0ｸ70ｹ0 o 0903fi00 03o0ｹ ｹ0 EFPIA Sir Tom McKillop, o 縺 fi0ｹ ｸ7030ｸ707026ｧ80ｹ ｹ0 EFPIA 02. Brian Ager, ｹ Marie Claire Pickaert 07 apple 縺 ｧ ｸ7036ｦ ｹ0 EFPIA ｸ703 閨 apple6ｧ904090ｹ0 o ﾞ070206apple03fi00 03o0ｹ0 02o0ｸ7 6ﾑ8O ﾒ ｹ0, o 0903fi00 03o0ｹ0 02o0ｸ ｧ9o0ｸ ｸ o6ｦ0 6ｾ40ｸ70303fi09o0ｸ ｧ ｹ ｷ307070ｹ0, o 0903fi00 03o0ｹ0 6ｾ4 ﾞ026ﾑ86ﾑ ｦ003o0ｹ0 縺 fiappleo0ｸ703o0ｹ0, o 0903fi00 03o0ｹ ｹ ｧ ｹ ｷ304090ｹ oappleo ﾞ o0ｹ0 ﾞ0702. ﾞ0ｸ fi0ｹ0, o 0903fi00 03o0ｹ ｹ ｧ ｹ ｷ304090ｹ o6 506o ｧ9 0ｹ ﾒ2036ｦ0080ｷ307, o 00apple6ｧ o0ｹ0 0903fi00 03o0ｹ0 02o0ｸ7 6ｾ4026ﾑ86ﾑ ｷ3076ｧ9 0ｹ0 ﾒ ｹ0, ｹ 縺 o6ｧ ｸ7030ｸ70702 閨0ｹ0 020ｷ fi ｷ ｸ ﾑ O0602o 0004applefi02000ｹ0 6ｧ o 0406o fi 6ｾ40ｸ7006 5o6ｦ00306o 02o0ｸ7 6ｾ4026ﾑ86ﾑ8, o 0903fi00 03o0ｹ0 02. 縺 o0ｹ0 6ｾ40ｸ ｹ0 o ﾒ20704o0ｹ0 ﾒ0ｸ o6ｦ0, ｧ903090ｹ ｹ0, o06 ﾞ070206apple03fi00 03o ｾ4apple6ｦ003o0ｹ ｹ0, fi03 o0ｹ ｹ0, ﾒ0ｷ ｧ907o0ｹ0 09apple 0702ｨB6ｧ80ｹ0, ｹ0 6ｾ ｧ9 090ｹ0, 6ｾ402 閨08 07o0ｹ0 6ｾ ｧ9 090ｹ0, 0406o076ｦ004090ｹ ｹ0, 閨 o0ｸ7 046ｾ4 o ｹ0 ﾞappleo0402o036ｧ9 090ｹ0, ﾞ ｹ0 08o ｨB6ｧ80ｹ0, ｹ0 縺0003o030ｸ o0ｹ0, ﾒ ｹ0 6ﾑ80ｸ70306apple6ｧ9 090ｹ0, o0ｹ0 ﾒ ｹ0, o 縺 fi0ｹ ｸ7030ｸ707026ｧ80ｹ0 02o0ｸ7 6ｾ40ｸ707 閨0400o0ｸ ｹ o6ｦ004090ｹ ｾ ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

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34 13EFPIA ANNUAL MEETINGS ATHENS 2003 ﾇ ﾞ07 apple 縺 ｧ8 04/ ｹ0 EFPIA 02 Marie-Claire Pickaert ｾ4apple ｾ O ｷ307070ｹ0, 0903fi00 03o0ｹ0 02o0ｸ ｾ o06 ﾞ070206apple03fi00 03o06 02o0ｸ7 6ｾ4026ﾑ86ﾑ 縺0003o030ｸ o0ｹ0 ( 縺6ﾑ806O 0809 ﾞ6ﾒ2O6ｾ4) ｹ0 (GSK) (Aapplefi ) ｹ0 (Farmaserv Lilly), 08 ﾞ070206apple03fi ｹ ｸ7 6ｾ4026ﾑ86ﾑ8 6ﾒ2. ﾒ0ｸ o6ｦ0 (Organon) 縺 fi0ｹ0 縺 陦 0ｹ0 02o0ｸ7 6ｾ4026ﾑ86ﾑ8, o ｧ9 03 0ｹ0 (Famar) o 05. ﾞ00apple 02ｨBfi0903o0ｸ7 (09.6ｾ4.02.) O ｸ ｹ0 (Pharmanel), o 02. ﾆ ｹ0 (Wyeth) ｹ0 (GSK) O ﾞapple ｧ9 090ｹ0 (Abbott) 00 閨03080ｹ ｸ7 046ｾ ｸ7 6ｾ4026ﾑ86ﾑ ﾞapple ｧ9 09, ﾒ080ｸ fi ｸ7 096ｾ408 ﾞ ﾒ, Dirckx (Roche) ﾒ. 0302fi0302 (Roche) O 0903fi00 03o0ｹ ｹ0 096ﾑ802 ﾞ o0ｹ0 ﾞ0702. ﾞ0ｸ fi0ｹ0 34 6ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

35 13O ﾒ ｹ0, 09 閨03080ｹ ｸ7 046ｾ4 02o0ｸ7 6ﾑ8O02 ﾇ 02 6ﾑ 閨 / apple. ﾞ0707apple020ｸ701090ｹ0, 縺 fiapple080ｸ703080ｹ0 (Vianex) ｦﾐ ｨB08apple086ｦ003080ｸ7 縺 / ｸ7 08apple. ﾞ0707apple020ｸ701090ｹ0 ﾌ 02. Trevor Jones (ABPI) Roger Bolton O 02. ｦﾐ ｧ ｹ ｦ0ｨB0ｸ709fi 02080ｸ7 O ｹ ｹ0 020ｸ7036ｧ9000ｹ0 09. ﾒ (Faran), 02. 6ｾ ｧ O ｾ ｧ9 090ｹ0 A070206apple03fi ｹ0 6ｾ4026ﾑ86ﾑ8 (Janssen-Cilag), ﾒ ｹ0 00 閨03080ｹ ｸ7 046ｾ4 (FARAN), ｾ402080ｸ ｸ ﾒ2036ｦ0080ｷ307 (Elpen) 0903fi ｹ ｹ0 096ﾑ ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 35

36 13O Pluess (Novartis) ｦ0ｨB0ｸ709fi 02080ｸ7 EFPIA ANNUAL MEETINGS ATHENS 2003 ﾌ fi ｹ0 (0809S) fi ｸ7 6ｾ4026ﾑ86ﾑ ｾ40ｸ , ﾒ. 09apple 0702ｨB6ｧ8 (UCB pharma) 00 閨03080ｹ ｸ7 046ｾ ｸ7 6ｾ4026ﾑ86ﾑ ｾ fi0ｹ0 (0809S) O A070206apple03fi ｹ ｹ0 EFPIA Jean Francois Deheq ｦ0ｨB0ｸ ｸ7, 08 Michel Labie, (Sanofi-Synthelabo) A070206apple03fi ｹ0, ﾞ ｨB6ｧ80ｹ0 (Sanofi-Synthelabo) 00 閨03080ｹ ｸ7 046ｾ ｸ7 6ｾ4026ﾑ86ﾑ8 ﾇ 02 Maria Teresa Rico (shering Plough) o 046ｦ0ｨB0ｸ709fi 02090ｹ0, Aracelia Vila o 02. O ｯNeil (Wyeth) 36 6ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

37 13This SFEE Newsletter includes the main presentations covered in the four Newsletters issued by EFPIA on the occasion of the EFPIA Annual Assembly. The English addendum of this SFEE Newsletter includes the five EFPIA press releases issued during the Annual Meetings. "EUROPE MUST DO MORE TO ENCOURAGE INNOVATION FOR THE BENEFIT OF PATIENTS" SAYS SIR TOM MCKILLOP Athens (Greece), 27 May 2003 ｨC At the Annual Meetings of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Sir Tom McKillop, EFPIA President and Chief Executive of AstraZeneca, reviewed progress on priority issues for the pharmaceutical industry in Europe. Sir Tom stressed the need to strike the right balance between Health, Social and Industrial Policies: "Patients in Europe today have increasingly come to expect new and better medicines that will help them live longer, better quality and more productive lives than ever before. Through our intensive research, the pharmaceutical industry can offer them tremendous opportunities and choices in their personal healthcare and well-being. As the European Commission acknowledged in 1994, the legitimate concern to limit public expenditure and healthcare costs ｨC of which it must be remembered that medicines represent only a small fraction ｨC must not be allowed to jeopardize the future of pharmaceutical research in Europe. Public health and health care systems have nothing to gain from a weakening of Europe ｯs research-based industry. On the contrary, as one of the key contributors to scientific and medical progress, Europe ｯs economy and society, the success of the pharmaceuticals sector is crucial to the wealth and health of Europe". " ﾇ 6ﾑ80ｸ70306apple ｹ ｧ9 0ｹ0: 03 閨000ｹ0 0ｸ707 02fi ｹ o0ｸ70ｹ ｧ90ｹ0 046ｧ " 6ﾒ2o 070ｷ302 閨030ｷ3 040ｸ707 陦0306o 06o apple03 6ｧ ｹ0 縺 ｧ80ｹ0 6ｾ40ｸ707 閨03000ｸ704090ｹ ｹ0 EFPIA appleo0ｸ7 閨096ｧ ﾞ036ｧ ｹ0 26 ｨC ｸ8o0ｸ ｸ ｧ o07 6ｾ4026ﾑ86ﾑ ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 37

38 13EFPIA ANNUAL MEETINGS ATHENS 2003 Competitiveness: European Competitiveness: European pharmaceutical industry at risk pharmaceutical industry at risk Data for 2002 confirm that the European pharmaceutical industry remains one of Europe ｯs best high-technology sectors. It performs well on most standard measures such as employment (with qualified people), production (worth 160bn at exfactory prices), R&D (19.8bn invested) and trade surplus (with a positive balance of 40bn). However, key benchmarking indicators also highlight the vulnerability of the pharmaceutical industry in Europe and its steady decline in competitiveness compared to the US, which has increased its dominance as an attractive site for R&D and a ｮlocus of innovation ｯ. The European pharmaceutical industry, which has for many years been the world ｯs leading inventor of new medicines, seems to be marking time as its share of R&D investment declines under economic and regulatory pressure. High failure rates, the significant cost of clinical trials and the amount of time needed to get approval by the regulatory authorities are the primary reasons for the exponential increase in pharmaceutical R&D costs. G10 and Review of the EU pharmaceutical Legislation: the way forward As a response to the general concern caused by the deterioration of the industry ｯs competitiveness, the G10 process marks an important first step by establishing a discussion platform that involves and commits the various interested parties (Commission, Member States, Industry, Patients, Mutualities) to a set of 14 recommendations. EFPIA now expects the upcoming Communication from the European Commission to convert these recommendations into practical steps that will positively contribute to a pro-research environment in Europe. "G10 gives us a foundation for the way forward to improve the European market environment and address issues raised by the enlargement of the European Union. The review of medicines legislation offers the chance to consolidate progress towards a world class European regulatory framework", declared Sir Tom. It would be too simplistic to attribute the deterioration of the European pharmaceutical environment to a single factor. As a whole, Europe remains less attractive for R&D investments than other regions, the US in particular. The economic and healthcare environments, the science base, the investment conditions, the regulatory framework, and societal attitudes towards new technologies all contribute. "US patients are willing to embrace innovation ｨC they want to be informed and to have the benefits of new approaches to healthcare", said Sir Tom. "In Europe, research shows that patients seek increased access to healthcare information - people also want greater participation in health care policies. But Europe ｯs healthcare systems are reluctant to adopt new technologies - they do not seem prepared for the current and future healthcare needs of a European ageing population". G10 and Review of the EU pharmaceutical Legislation: the way forward For any further information, please visit the EFPIA website "For the first time in many years, there is a glimmer of hope that the issues really affecting the pharmaceutical industry are being discussed openly and constructively". "We need to maintain a high level of intellectual property protection, as well as an efficient and worldclass regulatory system in Europe allowing patients to reap the benefits of therapeutic progress more quickly. We need less bureaucratic government intervention which stifles competition, discourages innovation and creates significant inequity among European patients' access to new therapies. All of us - governments, regulators, industry, healthcare providers, and above all patients - have an opportunity to work together to deliver a vibrant pharmaceutical industry for the benefit of the 450 million citizens in an enlarged Europe", concluded Sir Tom. 38 6ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

39 13REVIEW OF EU PHARMACEUTICAL LEGISLATION: EFPIA CALLS ON MEMBER STATES TO ADOPT WORLD CLASS REGULATORY FRAMEWORK FOR INNOVATIVE MEDICINES Ahead of the EU Health Council (2-3 June), the European Federation of Pharmaceutical Industries and Associations (EFPIA) reminds EU Member States that a key objective for the review is to help the pharmaceutical industry find new and better treatments for the benefit of patients. "EU Member States have an opportunity to set a more favourable legal framework for research and patients for the next years", said Brian Ager, EFPIA Director General. "The Commission ｯs initial proposal presented a balanced package. There is growing evidence of the relative decline of European industry ｯs competitiveness in the pharmaceutical sector. This review is an opportunity to contribute to improving the situation". Key priorities for EFPIA are: 09 Regulatory Data Protection ｨC Industry supports 10+1 years data protection as endorsed by G10 ｨC This will be an essential driving force for research in Europe. 09 Regulatory Procedures - Industry supports improvements to ensure a strong and effective EMEA/Centralised Procedure, together with improvements to facilitate business operations. 09 Business Flexibility - Industry supports legislation to facilitate business operations. Commission Commission welcomes agreement by Member States on Pharmaceuticals Reform welcomes agreement by Member States on Pharmaceuticals 09 Pharmacovigilance ｨC Industry strongly supports the strengthening of the EU market surveillance and pharmacovigilance system. 09 Added Therapeutic Value ｨC Industry believes that introduction of the concept of "added therapeutic value" as a criterion for product registration would have a negative impact on public health. 09 Information to Patients - EFPIA welcomes steps that allow patients and consumers better access to medicines information. "If these points are not addressed, Europe will take a serious step backwards. We support the Commission ｯs initial proposal on regulatory data protection (10+1 years), a strong and effective EMEA, and improvements in the Centralised Procedure to allow business flexibility", declared Sir Tom McKillop, EFPIA President and CEO of AstraZeneca. "We call on EU Member States to encourage pharmaceutical innovation. In the light of current and future disease threats (e.g. SARS), it is clear that patients and Europe in general can only benefit from industry ｯs capacity to innovate to defeat disease. In any event, the future of Europe will not be secured by its ability to copy". Brussels, 2 June 2003: Today, the EU Health Ministers reached an agreement with qualified majority on the proposals by the European Commission to modernise the current pharmaceutical legislation in Europe. These proposals consist of a package of proposals for three legislative acts: a Regulation on the European Medicines Evaluation Agency and its marketing authorization procedure and two Directives on human medicines and on veterinary medicines respectively. Erkki Liikanen, European Commissioner for Enterprise said: "with today's agreement, we have taken an important step towards ensuring that Europe gets a more robust, modern, effective and competitive regulatory framework for pharmaceuticals. Despite the fact that Reform For any further information, please visit the EFPIA website ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 39

40 13EFPIA ANNUAL MEETINGS ATHENS 2003 the Member States on some issues did not follow our proposal, this is a well balanced compromise. We are now looking forward to discussing these issues with the European Parliament with a view to hopefully formally adopt this regulatory package by the end of the year." At today's meeting of the Health Council, the Member States focused their discussions on two points of particular importance, namely the scope of the mandatory centralised marketing authorization procedure and the so-called data protection scheme. These two issues have been, from the very beginning of the Council discussions, the more sensitive ones. Regarding the scope of the mandatory centralised marketing authorisation scheme, the Member States agreed that this should cover medicines for the treatment of cancer, aids, neuro-degenerative diseases and diabetes. In addition, the Member States agreed that the industry would have the choice between the centralised procedure and a de-centralised marketing authorisation procedure (at Member State level coupled with a scheme of mutual recognition) for medicines for other types of diseases. The Commission had initially proposed that all medicines containing new substances would be covered by the centralised procedure. Erkki Liikanen said: "the reinforcement of the centralised procedure will help speed up the marketing authorisations in Europe. This will mean faster access to market for the pharmaceutical industry and quicker access to newer and better medicines for patients for these types of illnesses. This is a genuine win-win situation." Regarding the period of data protection for medicines, authorisied under the mandatory centralised procedure, the Member States agreed that this should be ten years with the possibility to extend this by one year if the producer can demonstrate that the medicine in question can be used for a new treatment. For medicines authorised under the de-centralised procedure or under the optional centralised procedure, the period would also be ten years with the possibility of generic medicines to launch their application for marketing authorisation two years before the expiry of this ten years period. Erkki Liikanen said: "this agreement represents a good balance between keeping the necessary incentives for innovation in Europe whilst ensuring a better access for Europe's patients to generic medicines". EU Council Gives Mixed Signal on Innovation and Research in Political Agreement on EU Pharmaceutical Legislation Brussels, 3 June - The Employment, Social Policy, Health and Consumer Affairs EU Council yesterday reached a 'political agreement' on proposals designed by the Commission to improve the regulatory framework for human medicines in Europe1. 09 While EFPIA welcomes some aspects of these wide-ranging proposals, it regrets that the Council has missed an important opportunity by not fully supporting the Commission's proposal to provide 10 years of regulatory data protection for all new products, across the board. Agreement on full 10 years data protection in mandatory Centralised Procedure is positive for innovation. However, the agreement to provide a weaker level of protection for all products registered through the Decentralised Procedure2, and optional Centralised, misses the opportunity to boost For any further information, please visit the EFPIA website ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

41 13the competitiveness and innovative capacity of the European pharmaceutical industry, and the research that patients need and expect. 09 The agreement on one additional year of data protection for significant new indications for mandatory products in the Centralised Procedure is welcomed. However, the Council's decision not to provide similar data protection for significant new indications in other disease areas is illogical, provides no support for research and innovation, and is ultimately detrimental to the interests of patients with these diseases. 09 EFPIA welcomes the agreement to build the EMEA 3/Centralised Procedure into a truly world class regulatory system for the registration of all new pharmaceutical products in Europe. 09 Finally, in view of the lack of agreement on the draft Veterinary Directive (also part of the legislative package), EFPIA remains concerned over the extremely tight timetable for completion of this crucial legislation prior to Enlargement in Unless a 'Common Position' is reached in Council on the whole package by October 2003, the Commission's legislative objectives - to guarantee a high level of health protection for EU citizens, to boost the competitiveness of the EU pharmaceutical industry and to simplify/rationalise the European regulatory system in order to prepare for enlargement - may not be achieved. 1. Amended Proposal for a Directive of the European Parliament and of the EU Council amending Directive 2001/83/EC on the Community Code relating to medicinal products for human use 2. For certain products (biotech products and medicines to treat AIDS, cancer, neurodegenerative diseases and diabetes) authorisation would be mandatory through the Centralised Procedure 3. European Agency for the Evaluation of Medicinal Products THE ROLE OF 6ﾒ2HE ROLE OF REGULATORY DATA PROTECTION FOR PATIENTS AND INNOVATION REGULATORY DATA PROTECTION FOR PATIENTS AND INNOVATION 09 Regulatory data protection encourages the development of new medicines for patients. Regulatory Data Protection plays a vital role when patent protection is weak or does not exist. This is the case for about 5 to 10% of medicinal products. The role of Data Protection is crucial in these cases as it gives the necessary incentive to develop important and life-saving treatments for patients. 09 Regulatory data protection refers to the protection of the clinical and pre-clinical data aimed at proving that a new compound is safe and effective and which pharmaceutical companies submit to regulatory authorities when they seek marketing authorisation for a new medicine. This is a massive undertaking involving patients, doctors and scientists in collecting and analysing huge amounts of information. These tests generally take between years to conduct and represent a considerable investment (up to 500 million euros) for innovative pharmaceutical companies that complete them. 09 The purpose of data protection is to protect this investment against unfair commercial use. During the data protection period, a generic manufacturer cannot refer to the data collected by a research-based company to register and launch a generic version of the same product. For any further information, please visit the EFPIA website ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 41

42 13EFPIA ANNUAL MEETINGS ATHENS 2003 EFPIA COMMEMORATES 25 YEARS OF MEDICINE RESEARCH "WE CAN ｯT STOP NOW", DECLARES PROF. TREVOR JONES Athens (Greece), 26 May 2003 ｨC To mark its 25th anniversary ( ), the European Federation of Pharmaceutical Industries and Associations (EFPIA) today inaugurated a special exhibition that will travel around Europe to illustrate the benefits and prospects of pharmaceutical innovation for patients. "Medicines for Mankind" celebrates the key contribution of pharmaceutical research to medical progress by presenting a snapshot overview of what research is happening in some 25 therapeutic areas ｨC It looks back on achievements and forward to opportunities for future medicines that are expected to further improve human health and well-being. The supporting booklet and accompanying documentation complement the exhibit by providing factual information accessible to anyone with an interest in a particular disease area. The aim is to provide a source of general information which is by no means comprehensive, but which should help European publics better understand a range of conditions, the nature of treatments available, as well as current and future research prospects. Prof. Trevor Jones, Director General of the Association of the British Pharmaceutical Industry (ABPI) and Chairman of EFPIA ｯs Group of Research Directors, declared: "Medical care has undergone a total transformation over the past decades. Indeed, 25 years ago, our understanding of the cause of illness was very limited. Through our intensive, lengthy, highly complex and dedicated research effort, new generations of therapies have been introduced that have revolutionised medicine, making once life-threatening diseases uncommon, and allowing millions of people to be treated and lead better or more normal lives. Major achievements have been made in the treatment of infectious diseases (like diphtheria, tuberculosis) and childhood illnesses, some forms of cancer, nervous disorders, stomach ulcers, asthma, hypertension and diabetes, to name but a few. Today, over 90,000 pharmaceutical industry scientists in Europe are researching new cures and innovative therapies for cancer, heart disease, HIV/AIDS, Alzheimer ｯs, Parkinson ｯs, arthritis, osteoporosis, cystic fibrosis and many other diseases. Researching the medicines of the future holds an alluring promise of answers to many of the universal problems of disease and old age. There may not be miracle cures yet, but ｮMedicines for Mankind ｯ points the way towards a brighter future for patients in Europe and all over the world. We cannot stop now!" 42 6ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

43 13EFPIA CALLS FOR EU ACTION TO ENCOURAGE THE DEVELOPMENT OF BETTER MEDICINES FOR CHILDREN Athens (Greece), 26 May 2003 ｨC In the context of its Annual Meetings, the European Federation of Pharmaceutical Industries and Associations (EFPIA) today organised a workshop on "Medicines for Children in the European Union" with the aim to assess and discuss the current and future scientific, regulatory, and legal frameworks, to respond to the needs for optimal medications for children. Keynote speakers included representatives from public authorities, regulators, paediatricians, patients organisations, and executives of the pharmaceutical industry: Mrs Frｨｦdｨｦrique Ries, Member of European Parliament, Dr Philippe Brunet, European Commission, Enterprise Directorate-General (Pharmaceuticals Unit: Legislative Framework and Market Authorisations), Dr Daniel Brasseur, Committee for Proprietary Medicinal Products (CPMP) and Paediatrics Expert Group at EMEA, Mr Ijsbrand Poortman, European Alliance of Neuromuscular Disease Associations and European Platform for Patients' Organisations, Science and Industry (EPPOSI), Dr Josｨｦ Ramet, Confederation of European Specialists in Paediatrics, and Dr Roger Bickerstaffe, European Forum for Good Clinical Practice. On behalf of the research-based pharmaceutical industry, Dr Daniel Vasmant, Chairman of EFPIA ｯs specialised working group on paediatrics, underlined the urgent need for Community measures to: 09 Encourage paediatric research and the development of specific medicines to treat diseases in children 09 Ensure a substantial and increased European contribution to the worldwide process of providing better medicines for children. Dr Vasmant called on all interested parties to make this their priority goal, and to foster open dialogue and exchanges in its achievement. In this line of thought, EFPIA released a new position paper, which provides detailed considerations in support of an effective proposal for medicinal products for paediatric use. MEDICINES FOR CHILDREN FOR CHILDREN The issue: Meeting the specific health needs of a fifth of the EU population In the European Union, 75 million individuals are younger than 16 years of age, a number that will reach almost 100 million in a Community enlarged to 25 Member States. The research-based pharmaceutical industry is actively contributing to improving their health and welfare. Thanks to new medicines and treatments, medical progress has been achieved in numerous paediatric therapeutic fields, including haematology, oncology, cardiac or renal transplantation, vaccination. Major improvements are also reported in the treatment of asthma, infectious diseases, neonatal respiratory distress, HIV, diabetes, neuropsychological dysfunctions, cystic fibrosis, or in the relief from pain. However, there is a lot to be done still to ensure that European children benefit from adapted medicines. As children are not "small adults", specific studies must be conducted to ensure that medicines prescribed in paediatric populations are suitable to their characteristics and needs. For example, a medicinal product intended for children requires appropriate dosage and presentation to ensure that it can be administered safely and easily. However, such pharmaceutical research involve specific considerations among which, timing of paediatric development, identification of appropriate paediatric formulations, difficulty in conducting pharmacokinetic studies, For any further information, please visit the EFPIA website ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 43

44 13EFPIA ANNUAL MEETINGS ATHENS 2003 conduct of tailored efficacy studies, and need to minimise risk and distress for children. This is made more complex by the specificity of various paediatric age groups (ranging from neonates to adolescents), as well as stringent ethical requirements surrounding clinical studies. The development of medicines in paediatric populations involves greater risk-taking by the originator. These R&D activities are nevertheless paramount as there is concern over the use of medicines in children outside the conditions under which the products have been approved (or "off-label use"). Government officials, the scientific community, health professionals, patients and their parents, and the research-based pharmaceutical sector are all in agreement that measures are urgently needed to ensure optimal treatments for children. Crucial need: Support and stimulus for the development of medicines for children ｯs use The need to encourage paediatric research was already highlighted in December 2000 in a Resolution of the European Health Council. It was reiterated in May 2002 in the framework of the G-10 High Level Group on Innovation and Provision of Medicines, which highlighted the need for Commission and Member States to "put in place an effective policy in terms of incentives to research and support the development and marketing of orphan and paediatric medicines". The announcement of a European Commission ｯs initiative in February 2002, with the release of a consultation paper outlining some suggested approaches, raised hopes among relevant interested parties. However, the research-based pharmaceutical industry in Europe is still expecting specific, concrete measures to provide the necessary support and stimulus to R&D activities for paediatrics in the Community. It is time to ensure a substantial and increased European contribution to the worldwide process of providing better medicines for children. 44 6ｾ4f6ﾑ86ﾑ ｦ004080ｹ0 47

45 13INNOVATIVE MEDICINES CAN SIGNIFICANT INNOVATIVE MEDICINES CAN SIGNIFICANTLY IMPROVE PUBLIC HEALTH IN ACCESSION COUNTRIES, STRESSES EFPIA IMPROVE PUBLIC HEALTH IN ACCESSION COUNTRIES, STRESSES EFP Health and Enlargement Role of the pharmaceutical industry Athens (Greece), 28 May 2003 ｨC On the occasion of its Annual Meetings, the European Federation of Pharmaceutical Industries and Associations (EFPIA) organised a workshop on EU enlargement entitled "European Healthcare in 2010", bringing together over 180 EU and accession countries ｯ policy-makers as well as senior pharmaceutical industry delegates. Although EU Enlargement is just around the corner ｨC with ten countries set to join the EU on 1 May 2004 ｨC EFPIA Director-General Brian Ager pointed out that accession countries still face enormous public health and health care challenges and that the standard of healthcare provision in accession countries have actually not been part of the accession negotiations, which concentrated on candidate countries capability to implement the acquis communautaire. The Workshop had instead focused on the issues that would matter most for the citizens of the new members ｨC the evolution of healthcare needs, the reform of healthcare systems, the empowerment of patients and the role of the EU. Recent Commission analysis had suggested that it might take the new members 40 years to "catch up" with the existing members, both in GDP and in healthcare investment. Mr Ager questioned whether more could be done to bridge the "health gap". Referring to a recently observed trend of some accession countries to respond to external financial disciplines by reducing the share of their budget dedicated to healthcare, Friedrich Breitenstein, chair of EFPIA ｯs Enlargement Action Team, challenged the assumption that this was cost-free, arguing that increased investment in healthcare is absolutely critical to the longer-term success of enlargement. It must be clear that innovative medicines can play a significant role in improving the quality and efficiency of healthcare delivery as well as improving overall socio-economic welfare. "Our priority therefore is to ensure that our research-based industry is rightly seen and valued in the Enlarged Europe as an important and positive contributor to public health", said Mr Breitenstein. "The success of the EU enlargement project in the pharmaceutical area will depend on guaranteeing the flow and availability of innovative medicines in newly acceding EU states, without jeopardising the foundations and legitimate interests of European research-based companies", stated Mr Breitenstein ｦ004080ｹ0 47 6ｾ4f6ﾑ86ﾑ8 45

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