High Level Pharmaceutical Forum е ещ еєе еэ е есеёеъе еэ ехеыеєея е еёеяеї. е ещ ешеєехещ ес еуещес еєея еўея еєе еэ еёесеёесетеые еэ

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1 High Level Pharmaceutical Forum е ещ еєе еэ е есеёеъе еэ ехеыеєея е еёеяеї е ещ ешеєехещ ес еуещес еєея еўея еєе еэ еёесеёесетеые еэ е ея еёесес еєеяеї е е е е еуещес еєея еёесеёеэ еъесещ еєея еыеыеяеэ The Vision of SFEE Ensuring a Bright Future for Patient Healthcare p.22

2 2 в fiбд 3 втвивп appleви бд б виappleбдвк ил бд appleбдбд ви High Level Pharmaceutical Forum - appleбдв бд ви виappleвив бд. б. бєбдfiappleвиви 5 High Level Pharmaceutical Forum б fi бд 6 в бд б appleбдfiбд 6 в appleви бд в имбдвп 8 бю йев бд бд в appleбдбдfi appleви бдбдйебд б бюим 10 бдбд ви втимб б бд appleбдfi бд в 14 в бдбд б бюим б бдвпйе вийев ви б бюим 15 б виappleбдвквп йев бдбд 15 вов бєбдfi бд бд в бдв бдвп имвпбдбд 16 в EFPIA бдвл в бєбдfi бд бд в бдв бдвп имвпбдбд 17 Innovate Medicines Initiative в бдвиappleбдвк в вибд fiви-еёв в в бд 18 бю в appleбдfi EFPIA бд в 20 в apple ви бдйе бд fi вп бд вибдбдв бд впбдбд - б в бд бєбдвийеви б бдв EFPIA 22 The Vision of SFEE Ensuring a right Future for Patient Healthcare 26 Greece cuts off-patent medicine prices by 20% 27 Increased Seizures of Counterfeit Medicines in Europe Highlight the Need for Patients to Purchase their Medicines through Certified Distribution Channels 28 The Innovative Medicines Initiative Launches New Website 30 Paediatric medicines 31 The Board of SFEE newsletter в 61 б бєб игеёбювт 2006 fi втвив ви втимб б в fiв в втapple. им имб игб втб б еёб б б б б б applefiв в бдвп б appleв ABBOTT Laboratories б вп б б б игвп б бдfiappleви SANOFI-AVENTIS б.б. Tвп Zбдвп WYETH Hellas б.б. б Kбдвлвивп GLAXOSMITHKLINE б.б. бєбд игappleбдвл UCB Pharma б.б. бд вовпв бд CANA имбдбдвивп б бдбд б.б. б fi б бдбдв бд бєбдбд бєбдв бд PFIZER Hellas б.б. бдбд бєбд б виappleв GENESIS Pharma A.E. игв втappleв Bбдйевп NOVARTIS Hellas б.б. в бдбд б вивп в. во. б б бюб игб бювт б.б. игвп бєвпбд имб б во б б б втвп Kfiбд ASTRAZENECA б.б. б бєбдв BRISTOL MYERS SQUIBB б в б б игвивив CHIESI Hellas б.б.

3 High Level Pharmaceutical Forum втвивп appleви бд б.б. бд appleбдбд ви Pharmaceutical Forum вив, в бдбдви 29 втappleви 2006 в бдв бд ви виappleвив бд. б. бєбдfiappleвиви бд йебд бдбд бд бд appleappleвпйебд ви Pharmacceutical Forum, бд вп бдapple б впв бд бд в бд appleбд бд бд бд вибд б appleapple applefiapple бєви имfi бд бєвиappleбдв бд бдви appleвибд бдйе бд в в бд ви втвививи бд виapple. бєви бд бєв втвивпв, в виappleбдвк apple в бд ви бдвпви бд fi вибд бд бдбд бдвп бд в бд fi вив appleappleв в ви appleбдбд в fiбд вибд. в бдбд бдбдви бдвп йебд ви бдйе в fi йебд в ви бдв applefiбд fiбд бд бдбдвивп appleвкfiбд appleви в ви бдвп, бдappleбдвпбд бдвиfiбд в бд виfi appleappleв бдвпбд. в бд, fi виappleвп в appleбдfi бд в бд бд бдвибдfi fi appleбд бдбдви appleйебд. б applefi бд appleвивп, applefiв бдбдви в вибд в бдбдбд appleappleв вл бдв бд бдви бдвив ви appleбд бдapplefi вп, fi в вибд бд бдвпappleви в бдвп ви бдвивп бдappleв бд вив в в appleвкfi бд appleбдв ви ви appleвмappleв вибд бд бд' appleв бд бдбдви в бдappleвп. б appleappleв, apple appleйевив бдapplefi бдбдви appleвкfi бдfi в вибдв в бдйе бд applefi applefi вп бдбдви йебдappleбд appleви йебд впви. в в вийе бдви бд ви имбдбдвив имfiви бд в бдбд бд fiви. вт бдвиfi впв applefi, вийев бд виappleвпбдбд впв бдбд бд йебд appleйевив бд вибдбд бд бдбдйев в appleбдбд вп бд йев бдбд appleви бдбд имfiви. в бд б appleвл имбдвп ил в бдappleйе fi appleappleвпйе вивп ви fiви бдвп appleв apple бд вив в бд бдapplefi бдв бдappleв fiбд в бдйев applefi. бдв, бд впви appleйевиfi fi бдfi в вибдfi fi. б apple, бд бдвпбд виapplefi в fiви-бдappleбдfiбд appleбд вив в бд впбд виapple вибд, впв ви appleappleв в ви вибд бд бдв applefiбд вл, appleбдвп apple appleв в бдбдвив в бдappleвп бдвп бд вибд apple. 3

4 High Level Pharmaceutical Forum в в ви бдвпв бдбд fi бдбд б виapple appleв apple бд appleвпбд бд бд бдбдбд в бд бдapplefi в бдбд вибдбд бдйев бд бдappleвл бдвп. бдвиfiбд, вийеfi appleбд бдбдви apple йебд appleв apple бд в бдбдfiбд бдбдви бдбд в вив бд бд appleв бд в вп fiapple apple.. appleбдбд бдвп. бд в бдв бдappleв apple бд бдapple бдбд бд-, fiappleви бдвиfi бд fi. б apple, appleв apple бд йебдв ви бдбдбд бдбдвп appleв бд вивп бдйев бд бдappleвл бдвп в вп. втвиapple, appleви в бдfi бд йев бд в бдви appleв бд бд бдappleв бдбд бд бд вибд. б appleappleв, в бд бд fi applefiбд бдйе вп apple бдбдви appleйебд бд в ви. впвлбд apple в fi бдви applefiбд в appleв apple бд бд вп applefiбд бд бдвпбд бдбдви appleвкfi. в в ви applefi fi йебд appleв apple бд в йе в бд appleбдбдв йе бдвпбд бд бдappleбдfiбд appleвкfi вп вибд ви бдвп бдйе apple бд в appleapple бдбдви в бдappleвп ви appleвмappleв вибд бд бд бд бдбд ви бдвпви вийе бдйе бд appleбд. вт б appleбдfiбд имбдвп б бдapple втвивпв, fi fi бдвпви йебд appleв apple бд бдбдбдвп бдбд ви. б appleв, бдfi бд в бд бдбдви бд бд бдapplefiв в fiви- бдappleбдfiбд йебд appleв apple бд влбд бд йев бд, вп бдfiapple в в в, бд бдappleв бдбд бд бд вибд. в в ви fi впв бд бдбд вт б appleбдfiбд йебд бд fiapple бд вп в вибдfiбд бд fi бдв appleбд applefi appleappleв бдfi бд вибд fi в бдвп appleбд бд fi appleбд виapple вибд бдapplefi бд бд. в fi б йе иг бдйеfi fi appleбдбд ви бдйе, бд в в в бдвп бд йе applefi ви. вт впйе appleapple fi, йебд appleв apple бд виappleвп бд в бдfi бдв applefi бдйе бд appleйе бдвп. б apple, бдвп в appleбд вп в в в виappleбдвкfi appleappleв, appleвп fiви бд appleв. вт бдвив вп, впйе apple applefi, бдapplefi fiappleви бд бд appleв бд, йебд appleв apple бд в бд вп, fiapple бд виfi в бдвпбд applefiбд в (apple.. впв бдйе бд бдбд). бюбд бєв втвивпв, appleйеви бд вп йе бд виapple бд вив бд ви имfiви. Eвибд 4

5 High Level Pharmaceutical Forum/б fi втбд вт 29 втappleви в apple вивп ви High Level Pharmaceutical Forum. бю 25 appleви бд бєбд-иг б виappleбдвк ил вивлбд appleвп впв бдбд бд вибд бд appleбдfi бд applefiбдбд бдбд бд б applefiв в ви: иг. игбдвп (Roche) Public б ffairs Officer бю впв бдбд бд: Working group on information to patients Working group on pricing Working group on relative effectiveness Forum вийев бдбдвп applefiв ви бд впйе впв бд бдбд бд бд виappleвпбдвп. Information patients в впв бд бдбд в applefi бд вивив Commission applefi fiapple йебд йе applefiбд apple appleви бд в бдйев ви б виappleбдви бдйе бд в бд впбдбд. иг appleвибд бдви виappleбд бдйеfi fi appleви в ви appleбдбд вибд appleбд apple ви бдйе бд впбдбд бд йев бдбд вибд fiбд. втвив бд йебд бдбдappleвийе в бд в втвибдбд fiви - еёв в в бд бд бд appleв ви вивп бд бдйев в бд бдappleбдfi бд бдйеfi fiapple. бд в вийе apple в вибдfiбд в ви бд впappleвлбд в в в бдбдв бд в бд appleвп apple. в впв бд бдбд бд appleбд apple ви бдйе в в йе еёбдвивп 2006 бд бдбд : бд) в бдfi fi в ви appleбд apple бд бдйев appleбд в бд apple appleбдвпв бд. ) бдбдвл appleв ви (areas) бд applefi бдв в б виappleбдвкfi appleappleв fi бдвп appleбд apple бд впбдбд. ) applefiбд бдйе бд applefiбд apple бд вибд appleйебд, бд бдбдбд бд бд бд бд fiapple бд appleйе fiбд applefiбд applefi. втвиappleвпбдбд Pharmaceutical Forum бдвл applefiбд бд бдвп в б виapple бд appleбдбд ви applefi бд в бд бдбд бд appleвп applefi бд бдйев бд впбдбд бд ви б виappleбдви apple. 5

6 бд в бдбд б appleбдfiбд б б еёбю в бю бд в 2/ /11/06 6 в втapple. им имбдбдapplefi в fiв & вийев втв ви имб игб втб - б еёб б б б б в fiв втимб б бю имбдбдвив б бд в йе бд appleйевибд вп ви бдйеappleви бдappleв бд бдйев бд бд йевп. бю впв ви бдвпви appleвп впйе вп впв appleбдfiбд бд appleв в в вибд бд бдвпappleви. бд в бд впбдбд бд в йебдapple бд вибдбд appleвп appleв бдбд, appleви вивпви бдйевп applefiбд вл бд бдв вив бд appleбдбд вл бдйеapple. йкfi, ви бдapple бдбдви бд в в вив бд бд в в бд бдapplefi бдappleвп ви впви. бю втв в имбдбдви б apple б впв вп fi appleви б впappleви в вп бд бдв вп бд бд в бдв бдбд бд appleappleвпйе бд appleв fiбд appleбдбд fi бд вибд бдвп бдвпви. йкfi, appleбдвп вп appleappleвпйебд бд ви appleвиви б впappleви бд fi бдfiв appleбд в бдбдfi бд бд войебд вп fi бдвп бд бдapple бдвп, бд appleбдбд ви appleбдйеfi вивлви бд вибдбд. в apple бд appleв apple бд appleйе бд влбдбд: 1б йе бд йебд вл fi бд бд имбдвп appleв apple бд в в бд бдfi впйе 90 в, в в fiйе бдйевив 4. вт в впбд бдвиfi в бдйе в бд applefiбд в бдбдвив йебдapple appleви впвлбд - бд apple вп apple б виappleбдвк ил бд бд в ви вп applefiбд. 2 б appleбдви fi fi appleв впви бдйев appleбдбд, бд бдбдв бдвп в бдвийе, бдвиfi йебд в appleapple бд вп в бд бдбд в впбд. вт fi, бдвп бдви appleви в fiйебд в бд fi бдapplefi бд appleбдбдвп, вп бд бдбдв бд впбдбд, йев ви бд ви в бд fi в йе бд в бд бдбд в впбд, appleбд appleвп бдвп бд appleв apple бдapplefi в fi б виappleбдвк ил бдfi в. втвив бд, впйе бдвпви бд apple йе бдв бдвийе бдfiбд бд бд бд бд бдfi бдapple' бдви appleви йебд в appleapple бд в вп в бд бдбд в впбд. бдв, впйе бдвпви бд apple йе бдв appleбдбдв бдfi бдapplefi в fi ви вив ви бдвпви fi б б, в бдв fiappleви впбд бдвиfi appleбд бдfi вивп виapplefiapple ил. в бдвпбд, fi, в бд бд apple ви 4% бд бдбдвп бдбд, appleбд бд в бд бдбд в впбд. б бд бдfi fi apple в бд бдбд в впбд apple бд вив бд бдбдви бд.

7 3 appleви б впappleви бдйе вп в вибд appleви в в бд бдви впбдбд appleви в бдв бд, вп вибд appleв appleв apple бд виappleв. бю виappleв бдвив в в бд бд бдбдв ви бд бд в ви бдвп. в ви бд бдбдви бдв fi appleбдв в бдвп бдapplefi 1997 в ви в имбдбдви б вп бд вп appleвп бд виfiбд apple бд бд : б applefiви бдapplefi бдвп appleбдбд, бд бдбдв бдвп бд вибдбдбд в бд бд бдfiбд впбдбд, вив appleбд в fi в бдappleбд бд. бєв ви бдвп бдapplefi бдвп fi appleбдбд бдв, fiappleви ви бд бдвп appleв виfi. б бд имбдвп appleви appleви бдapplefi бдвп в ви бдв еёимб appleв виfi в бдapplefi влв бдви бдappleв бд applefiйе appleвпви бд бдбдвп бдбд. appleви б впappleви вибдбд бд appleв бд appleбдбдappleвп appleбдбд бдappleбд бд бдбдбд бд в бдви впбдбд appleви в бдв бд в бд йебд, в вп appleв appleв бдви apple вибд в бдвлви бд бдв appleбдбд бд в бд бдйе fi йе fi бд йебд. бю втв в имбдбдви б apple б впв (втимб б ) appleв fi fi ви appleappleвпйебд fi applefi в йебд бдappleйе бдвп бдвп, йебд в вивийе вп applefiбд бдйе fi в бдйев бдбдвив йебдapple бд виfi йебд йев в бдappleвп бдбд бд. в, втв в имбдбдви б apple б впв appleбд бд бдfi бд вп в бдбд бд appleбдбд бдвп бд бдбдбдfiбд в вп бд бд appleви appleв apple бд йейейев appleв ви бд бдбдвп appleбдбд бдвп бд бд. 7

8 бд в бдбд б appleбдfiбд бю йев бд бд в appleбдбдfi в бдвп вп бдв appleбдбдfi appleви бдбдйебд б бюим appleбд appleв appleбд бдapplefi applefiбд appleви б applefiбд 10/8/06* бд бдбд бд в в бдбд- вив apple бд бдйевп бдв в бд впйе в бд appleбд appleвибд ви бдвпви. вт 6 еёвиви 2006 б бюим apple ви втвив в ви имбдбдви б apple в в appleви б applefiбд бд бдв appleбдбдfi apple appleв apple бдви бдapplefi 150% в 2.233%. вт 14 еёвиви 2006 вийе бдapplefi б бюим бд втимб б, appleapple applefi appleбд бдв в бд виapple' fi в appleбдбдfi вп б. ил бд fi fi вибдбд бдв appleбдбдfi в 1998 ви бдв appleбдбдfi бдapplefi 67% в 1.233% бдвпбд appleapple. в бдбдв бд вп бд в fi бдвпви в appleбдвп бд 6.000l в в apple. б applefiбд appleв apple бдв l (бдappleбдбдfi) бд appleapple ви бдв l в бдв 150%. в -еёв в бдвп в бдвп в бд appleви б applefiбд б в в fi бдapplefi б appleapple б applefi appleбдвп б в 6.000l l 317% l 150% вт 26 еёвиви 2006 втимб б в бдfi ви в fiв ви б бюим.. бдвп ви вл бд йе appleви бд в в appleви б applefiбд в бд бд applefiбд бдapplefi б appleapple б applefi в appleбдбдfi. иг вп бд в apple в бдappleбд fi 10 б вив ви в в йе appleви б applefiбд бд йев бдйеfiви виapple' fi appleвп appleapple. еёв бдбд в ви бд бдв ви appleбдбдfiви бд в бд бдapplefi 1.500l appleви бд l (бдв 1.233%) applefi бдв бд l (700%). вт вив бд втв в имбдбдви б apple втимб б бд в б им бдв йебд appleв apple виappleвиfi бд. б йе. б бдfiappleви, бдбдв бд fi б бд в бд appleбдвпбд бд виappleвп вивп бдappleв бд бд appleбд бдвп fi apple ви впв ви бд бд в бдбд в в appleб. б apple, бдбдв бд fi б виappleв бдви впapple appleapple appleв 1.300% appleви бдв бд вп appleбдвп-в fi в в в бдвийе fi appleв б б в йе бдfiв бд виappleбд ви apple. бд вл fi в бдfi бдapplefi б бюим бд бдappleбд apple. бд fi, fi виappleвп бд appleв fi ви в ви appleбдбдfi, бдйе apple бдapplefi ви бд виfi applefiбд appleapple fi apple. б applefiбд. 8 * Yapple. б applefiбд б 3бд/б.в /05/имб бє 1098бп/

9 б впв бд в бдбд имбдв бд вобд б вибд еёбдв бд еёappleбдбд бдapplefi 6.000l l 2.850l 9.500l l l l l бєбд fiapple бд бдбдйев в appleв, fi бд в бд бд вп бд в бд вп б виappleбдвк ил. вп в appleбдбдfi вп б. ил бдвп appleapple appleви бдвив бдбдбдвпви виapple- в бд йев бд в fi бдвпви бп fi- бд fi б. ил бд-бд бд appleбдбд б бдбд б бд- бдв вибд. в б впв бд в в в бд бдбдвп fi бд-бд бд в бд в бд appleви б applefiбд appleapple бдви appleбдвп appleви бдappleбд б бюим бд l. б в вп бдбдв бд fi apple виfiви 954 бд бд в бдвп appleви вп- йебд в бдв бдбд бд- бдбд бдбд 2005 б - впв бд в бдв бд fi - бд бд. б appleбдбд fi в appleбдбд- fi б. ил apple apple бд вийе б впв бд, (в бдв apple бд бдвп вп в йе вибд- бд appleappleв бд бдвпбд бдвивп б впв ) fiapple в бдбд, еёбдв бд, б вибд, вобд, имбдв бд, еёappleбдбд в бдбд appleв бдfiбд appleappleв бд fiapple бдбд бдapplefi appleбдбд appleви бдвийе. б бд бдйеfi ви в ви appleбдбдfi йебд appleв apple apple бд йев виapple' fi бд вп в йе appleви бдйевлви бдвп бдвп. бдfi - fi в йе бд fiapple бдйев бдвп. бю бюбдfi имбдвп еёбдв бд (Irish Medicines Board) бдfiвл бд бдбдйе ви в ви appleбдбдfi вп бдapplefi apple в бдв ви бдбд. вт appleвив в apple- в виapple ви бд бдв appleбдбдfi бд в 2007 бдбдв бд fi бдв йебд бд 3% в бд appleйев 4% бдapplefi l l. б вл бд appleбдйе fi бд бдбд бдвп бд appleбд в бдвийе бд appleбдвп бдapplefi 1982 бдв ви appleбдбдfiви бдapplefi 1/1/2007 йебд бд 100%, appleйеfi бдйевп бдapplefi 1982 в бд бд 177%. вт в в виapple бдбдв бд fi бд appleв в ви - бд бд appleбд- бдбд ви бюбдв йебд в ви бдappleв бд - втвиappleбдбдвп, бд бдapplefi fi в appleбдбдfi, fiapple бдйе бдapplefi 10/08/2006 бд виapplefi бд appleбдбдfi бд в йе бд бд в бдбд бдбдвп бдвп бд бдapple бдfiбд бдapple, в бдбд бд в в бдбдви- в apple. в в бд в бдйе в бд appleв бдfi в бд бд- йев бдвлfi в fi бдfi впйе бдвпви б виappleбдвк ил. б виfi бд в бд в fi бд бд- fi бдfiбд apple apple бд бдйе бд' бдбдбд бд бдйеfi ви в ви appleбдбдfi бд fiбд йе йе бд впбд бд вибд. бд applefi вп бд appleв в appleбд йебд бдвийе бдбд бдвп applefi бдбдйе ви в ви appleбдбдfi. в бдвпбд appleбдбд fi вибд ви бюбдв бдйе- влбд бдapplefi appleappleвпйе бд appleбдв бдбд виapple. бдвп бдбдвп бдвп бд вибдбд appleбд бд ви бюбдв - втвибдбд бд б бд- appleв (бюбювтб ), бдбдв ви fi бдбдви в бдappleвп б - впв бд бдйе 2004 бд 2,9 в б ви. втв бд appleбд - бд ви бюбювтб appleвп б впв бд бдвийе бд в бд- fi бдвп бд бдбдви- в бдappleвп бдв б вивл (264l). бю втимб б йебд бд впйе fi в бд йеfi ви в ви appleбдбдfi ви б бюим. втбд apple в бд appleв бд бдapplefiбд втвив б appleбдбд. в в ви fi йебд ви в йев в бд виfi в вибдfi. 9

10 fiбдбд бд бд в 10 в втapple. им имбдбдapplefi в fiв & вийев втв ви имб игб втб - б еёб б б б б в fiв втимб б fiбдбд ви в втвививи ви втимб б бд бд вивпви apple ви в ви бд илбд apple бдapplefi appleбдбдбд applefiв в вибд бд бдвпappleви в бдвп. в ви бд бд в бд виfi appleбдвпбд appleви appleвп в fiбд вибд в бд бдapplefi fi ви бдбд бдвп бдйев бд appleви вп бдapplefi бдбдвпви fi в ви бдвпви впapple бдfi в ви fiви бд бд вп вп бдapplefi appleвп fiбд ви бд бдвпappleви бд в бд ви бдйев. в apple ви в ви бд бдйе бд бд бдappleбд бдбд в вибд бд в бд бд в бдбдви бдвп. б бд fi fi впв ви бдвпви бд в бдбдви бдвп б впв бд бд бдвп бдв. йкfi, бдвп вив ви в в ви бдвив бд виappleбд. иг бдfiбд бд йеfi appleв бд бдбдбдйеви в виfi fi в бд в бд applefiвиapple виappleбдвкfi в бд apple fi fi бд ви apple fi ви appleйебд. бєбдвп вив appleбд, fiбдбд ви в втвививи бд apple ви в ви бд бдapplefi appleбдбдбд applefiв бдбдви apple вивлбд appleв appleв вив appleбдfi, appleви бдбдв бд appleв в fi бд в бдбдви бдвп: в fiбд бдйе fiбд бд впбдбд бд в бдбд бд в бд. в бдйевив applefiбд бдйе бд в бд впбдбд в бдв appleapple бд fi applefiбд вл бд appleв вивп apple бдйе. бдвп бдappleв ви в fiбд fi вив бдвп, вибд appleв appleв apple бдвп бд appleв вив бдвп. бд бю бд fiбд бд appleappleв бд в бд appleви бдвп бд виfi. бдappleбдв бдfi бд fi вп в бд бд appleйе бдвп. б ви бд виapple ви в ви бд бд б бдбдв в бд ви в ви бд бдappleбд ви втимб б fiви вив в бд.

11 ви втимб б appleбдfi 1 applefiбд бд впбдбд, applefiбд йебдappleбд в applefiбд бдйе бд впбдбд appleвпвлбд бдappleбдfi бдйеfi бдapplefi apple бд впбд appleви бдвийе бд бдfiвл в бд. б appleвпвлбд apple бдapplefi в бд ви вибд бд бдapplefi appleappleв ви в в ви в бд. игвп в ви ви воfiви бд игбдв йе ви втвибд имбдбдви в йебд бд бдвп бд, fiбд бд вибдбдв бд впбдбд бдв appleбд бдapplefi бдвп. йкfi, бдвп бд в бдбдвл вп applefiбд бдйе fiбд бд впбдбд. в вп applefiбд бд в бд впбдбд бдвпбд appleappleв бдapplefi вив appleбд в бд бд в в бд бд appleбдйев бдapplefi fi appleйе. в бд йе йебд влви fi в бдв бд бдйев appleв apple бд бд 90 в. вт б впв бд виappleбд в applefiбдбд вп бдйеви, appleви в бдбд в бд ви 19. втбд, fi, вивлв - бд apple вп - бд в бд виfi fi бдйеви в 90 в бд бдйеfi бд бдв бдapplefi бд бдбд. в fiбд бд бд йе в. fi в йе, fi бд appleбд в в fi ви fiви бд бдйеfi вив вибдfi в бдви бд впбдбд в бдбдвл вп бдйеfi: в : вп applefiбд бдйе fiбд бд впбдбд бдйе в бдви в applefi appleбдбд бдfi бдвп бд бд' appleв бд applefi бдвп. в : в бд бдвп appleбдбд бд бд йе бдвп. бд бдвп бд йевп впбдбд, fi бдбдappleбдfiвлбд ви, в бдappleв бд бд в бдбдйебдбд бдapplefi впбд appleбдappleвпбд, в ви бд вийе бдбдви в бдappleвп. в вп applefiбд бд впбдбд appleвмappleйев виappleв йеви вп в бд fi в в бд в в в, fi бд в fi. 11

12 в бд б appleбдfiбд 2 3 в fiбд имбдвп fiбдбд ви втимб б виappleбд appleappleвпйебд бд: б бдвп бдappleв ви applefi fi вив бдвп, в бдбдвлбд бдбдfiбд applefi, вибд б впв бд, appleв бдвп, appleв apple бд бдвп бд вибдвп бдвп бдapplefi бдfi бдappleвп apple ви бдбд в бд бд вп бдfi впбд applefiбд, йебд appleв apple бд йе fi впбд appleв apple бд бдбдappleбд appleв бдвив ви applefiбд. игfi appleви впбд - б в йквоигбю в йкбюв бю б в йквоигбю бювтеёйкйквт бюигбюеёбю (б бд) - apple бд appleв бдвив ви. бю йевпapple бдfi apple в бд вийев йебдappleбд appleв apple бд бдappleбдвл в бд впбд appleви йебд. бєбдв бд бдfi в йебд вибдбд бдбд в бд вибд appleбдвп fi apple бдбд. б бд в йев бд йев бдйе ви в ви бд apple бдбдвп впбд, бд applefiбд бд бд бдappleбдfiбд. б вп бдfi виappleйе бд вибдбд appleбд fi бдбд в бд вибд бд виapple влбд apple бд appleвкfi йебд йе бдйе ви, fi йебд apple бд вибдбд в бд fi applefiвиapple впбд, apple в йебд в бдбд бд йебд бд бдвп бдfiбд бдfi. виappleв бдбд бд fi apple вибдвп бдбд в бд вибд apple бд в бдбдви в бдappleвп бд бдвиfiбд бд в виappleвпйе ви appleappleв в ви ви appleйебд. бєбд бю бд бд бд во бю fi вп applefiбд fiбд бд впбдбд бдвпбд бдappleбдfi бдйеfi бд бдapplefi в бд бд бд во. бєвп в apple fi бд appleвийе в бд ви appleви в вив бд бдвп. илви вп вийе бд бд бдapple бд б впв бд в бд вп appleв в бд в бд вп бд бд во apple, fi бдapplefi вп applefiбд бдйе бд впбдбд, йебд вивп бдбдвивп ви fiви в бд ви вибд бдйе бд applefi fi бдв в бдйевп, fi бд appleбдвп appleбд бдвл в fi 20% ви бдбдви в бдappleвп. 12 fiбдбд ви втимб б бд: в втвибдбд в бд бд в в бд бд в бд б бд бд бд во бд appleвп бд бд бдвпйе appleвп applefi бдappleви appleбдвп applefi вив бд appleappleвпйебд appleви игбдвп ви вибд.

13 иг в ви fiбд, втимб б бдбдappleв бд в бд бд бд бд в бд бд бд apple вив вибдfi fi виfi ви вибд, в в appleви appleви appleв fi fi бд вибдви, бдвп бдfiбд бд бд ви бдбдви в бдappleвп applefi ви б.б.в., appleвивпбд бдвиfiбд бд впйе applefiбд ви appleйебд. ви бєв бд бд вт бд apple в, appleбдв ви applefi вибд в бд бд appleбдбд бд ви бєв бд бд ви втимб б бю втимб б appleйе в бд appleбдв ви applefi вибд в бдapplefi apple applefiв, appleви бдappleappleв впйе в впбд. илбд в впбд бд бдappleв бд appleвив в. ил в вибдfiбд бд вл бд applefiбд вл apple. впбд бдapple fi бдбдйеfi. б ' бдвиfi в бдвпвл впбд fi в бд, бдвп fi apple в. б виfi бдвийев appleвп в бд бд appleбдбд бд ви бєв бд бд ви втимб б. б applefiapple вибд ви в ви бд в вп applefiбд бдйе fiбд бд впбдбд appleвпвлбд бдбд бд бдapplefi ви бд. fiбдбд ви втимб б бд: в б ви fi appleappleвпйебд бд бдapplefiapple вибд бдвив бд в бдв fi appleвпбд, в appleбдбд бдвп бд бдвпappleви бд appleбдбд. в бдfiбд ви втимб б бдapple в бдвп appleвпбд бдвп бдвп. в бдв бд appleбдбд йебд вивп йевп fi бдв бдappleбдfi в вибд йев бдбд fi бд бдвпappleви йе бд в. бд впбдбд бдappleв appleв в ви йеapple бд бєбд в в бдappleвп бд впбдбд бд appleв в ви впйеapple бд бд. игбд в бд appleв йебдappleбд apple бд бд бдfi, бдвп бдвиfiбд apple бдйе бд бдappleв бд бд бд бдappleбд бд в влбд fi бд appleйебд. ил, виfi fi бд в бд бдfi бдбдви йебдappleбд виappleбдбдйевлбд бдapplefi бд в appleви appleв fi applefiбд вл ви бдйев fi бд fi applefi бдapplefi вп в appleйебд (apple.. бд appleйебд). бю в йебдapple appleв ви ви, appleбдбд, вл apple. игбд ви вл вп бд бд бдв fi fiapple бд бд бдappleви бд вибдбд вибд, в бд, бдвп бд бдвп. бєбдвп вив appleбд fi бд впйеapple бд бд бдapplefi applefiв бдбдви apple бд appleбдappleвп бдapplefi fi в йебдapple. втбд appleбдбд бдвивп, бд бдв, бдappleбдfiбд, вив в вп бд appleви втимб б apple вивп бдйевп apple ви в ви бд илбд apple бд бд бдapplefi appleбдбдбд applefiв бдбдви apple. иг fiбдбд, бдfiбд, вибд бдбд бд в бд appleвп бдв вл fi втвив ви втимб б йебд вибдйе в бд бд appleви appleвп вивпбд вп бдвиfi appleв fi бд впйеapple в бд в бд впйе в бд fi бд apple вп. 13

14 в бдбд б бюим б бдвпйе вийев ви б бюим бю б бюим бдбдбдйевлбд ви fi ви appleбдв виapple. втбд appleбдбд бдвивп 2006 в бдappleв бд вийев ви б бюим: в / б бд appleбд в вйбдбд. б. бєбдбдвп в бдappleв 8 игбдви 2006 бдapplefi б йеfi втв бд бдappleви б.б. (б.вт..) - бдfiв бд йе бд бдapplefi во. 3066/2002- в бд бдappleбд ви appleв appleви б б бю б во ISO/IEC в applefi бдappleви бд. 244 бд бд в в. в applefi в в 7 игбдви в / Eв ви в бдбд бд бєвибд в вкfi appleбд в вйбдбд бд. в бдбдвп, в бдappleв бдapplefi б йеfi втв бд бдappleви 30 игбдвкви 2006, в бд бдappleбд ви в в appleви б б бю, б во ISO.IEC в applefi бдappleви бд. 277 бд бд в, имв бд б в ви, в apple б, в ви в вкfi. в / apple бд б в ви в вкfi appleбд в вйбдбд бд б. бєвив, appleappleйе 21 еёвиви 2006 в бд бдappleбд ви appleв appleви б б бю, б во ISO 9001/2000 в applefi втвиfi втвибд в fiбд бд. 0213/1039 в бд б fi бєбдfi б fi бд в apple втвивп бд ви б б бю бд в applefi бдapplefi IQ Net (йев ви в apple) бдбдвп в бдfi: илв бдappleвп бдв вибд ( в appleвп) appleвкfi бдв fiбд б бюим, в в бд apple ви бд appleapple бд в / бд в бдви в бд виapple в виapple apple в / имбдбдви иг бд илвибд, б fi appleвкfi, б бд, б в ви в бдбд бд бєвибд в вкfi appleapplefi в в 20 еёвиви б applefiв в ви: втfi игвп (втимб б ) /бд б apple вп вов в вквп б бюим иг бдapplefiбд ви в в в ви ви б бюим.. бдвп в appleйев в вкбдв : 1.вт бд бд йе втв в йеви в fi бд втв бд её. б йебдбдви. 2.вт бд игбдбд б в в йеви apple бд б в ви в вкfi бд б. бєбд. 3.вт бд б в ви бєвибд в йеви б в ви в бдбд бд бєвибд. в. вобд. 4.вт бд б в в йеви б fi.. игбдвиfiappleви. 5.вт бд б apple в вкfi б в fi EOим в йеви б fi бд б. игappleв ви. 6.вт бд еёбд в вкfi в йеви б fi бд. йе. 7.вт бд б в ви б appleвпбд в йеви б в ви в бдбд бд бєвибд бд им..

15 б виappleбдвквп в бдбд вов бєбдfi б виappleбдвк ил бд бд в бдв бдвп имвпбдбд Regulation on Pediatric medicines* вт 23 бюви втвив appleви б.б., вийев бєбдfi бд бд в бдв бдвп имвпбдбд. бю бєбдfi йебд йе бд 30 в вп в ви ви б apple б в бд б виappleбдвк ил. бю бдfi вийе appleви appleв appleбд бд: 6 appleбдвпбд appleбдбд ви appleбдв ви 2 fiбд appleбдвпбд бдapplefiбд вибд (market exclusivity) бд бдвп б fi 6 бдapplefi йев в ви бєбдв йебд вибдйе бєfi б appleappleв в бд б appleapple б applefi бд бд в бдв бдвп впбдбд appleбд йебд: б бдfi йебдappleвиfi appleв бд/ йебдappleви бдвп бд в ви бдвпви бд appleбдв вп бєбдбд бдвпбд (inventory) йебдappleви бдбд бд appleбдв бдвп впбдбд бєбдйе в бдfi в бд бд appleбдв бдвп впбдбд (appleбдбдвп бд в бд) бд в в в бд йебд впбд вп EudraCT. бю apple йебд в appleв бд. в appleбдбдв йе йебд бд бдвив в бд бдapplefiйе бдappleбдfiбд. в йебд в впбд в бд в fi в бдв бд илвибд (Pediatric Investigation plan) в в appleбд в бд виfi apple бдappleбд ви бєбдв бд apple ви. б applefiв в ви: втfi игвп (втимб б ) /бд б apple вп еёв бд в бдв appleбдвивпвлви вийе appleви appleв appleбд бд бд впбдбд apple в appleбдбд ви в appleбд вибд (off -patent). fiбд бдв fi (public funding) бд бдвпappleви appleбдв бд бдвп. в appleв бд виapple appleвп (call for proposals) бд бдв fi бдбдв бд бд бдбдйе бдв ви в бд в вп apple виви бдapplefi б игб б втбд appleбдбд бдвивп бдйебд в бд в в apple впв бд вибд Pediatric Use marketing Authorization (P.U.M.A) бд 10 appleбдбд appleбд в бд apple бдбд (brand recognition) appleвпбд бд в в в бд бд в generics бд бд в бд в в в бд appleвп бд applefiбд в бє бє в бдв бдбд в appleбдвп бд впбдбд бд appleбдв бд appleви бд в бдв бдбд бдви appleв apple appleв apple бд вив бдвп. вт appleapple в бдapple вибд ви впв бд вибд бдвпвлбд. 15 *.. 30

16 б виappleбдвквп в бдбд H EFPIA бдвл в бєбдfi бд бд appleбдв бдвп впбдбд в appleви б applefiв в ви: в игбдвпбд (втимб б ) H б виappleбдвк бюappleв бд имбдбдви б apple бд втвив в (EFPIA), бдвл ви в ви бєбдв бд бд в бдв бдвп имвпбдбд. втвив appleви б виappleбдвк ил вийев бєбдfi вп бд впбдбд бд appleбдв бд appleви в вибд appleбдв appleappleв б.б., в бдвп fi бд впбдбд бдвивп, appleв йев вибд, йебд в ви бдappleв бд в в вибд бд бдapple вив йебдappleви бдбд. O бєбдfi бдвиfi бд бдapplefiбд бдв в бдв ви бд в в бдfi appleapple applefi в бдapplefi fiбд бд в бдfiбд в бд в : б бд apple бд бд в appleви йебдв ви в вибд, бдвпappleви бд в бдвп appleви в ви бдйе бд appleбдв бд, в вп appleви йебд влви appleбдв бд в вибд в бд бд appleбдбдfiбд впбдбд, бд вибд виappleбдвкв в в ви appleбдв бд в вибд бд бдвпappleви. бю б fi вийеви EFPIA. Brian Ager appleбд fi бд appleбдв вп бд йебд appleв apple бд appleв бд йев бдapplefi в бд бд в бд впбдбд в вп в бдв бд бд бдapple в ви йебдappleви бдбд. б виfi йебд appleвийе ви бдбдfiбд виappleбдвк бдбдви бдбд. бю бдбдвив бд в в впви в в вибд в бд бд в бд впбдбд бд appleбдв вп, бдвп в бдfi йебд appleв б виapple бд бдбд fi fi бдвпappleви бдfi бдвп appleбд, бд бд бд вп appleв fi fiappleви бдappleбдв appleбд бд appleбдв бд в вибд в в йе в appleв ви бд бдбдappleйе бдвп бдйе, applefiйе Brian Ager. бд appleв бд бдappleв бдбд fi бдвп в fiбд вибд бд applefiбд вл бд бд appleбдв вп бд ви ви бд бдfiбд. б бд fi fi бд втвив в apple в бд йе бд бєбдfi бдйевив. 16

17 Innovative игedicines еёnitiative (IMI) в бдвиappleбдвк вибдбд в ви - в в в бд бд бдfiбд впбдбд в в вибд бєбдfi имбдвп (Innovative Medicines Initiative - IMI) бд бд бдв в бдвиappleбдвк вибдбд в ви бд в в в бд бдв вп бд бдбдви бд, бдв бд, appleбдapple бд бдйе бд бдв бдбдвпви бд бдвпappleви бдappleбдfi бдвп. в еёигеё бдбдвл appleбдвп appleвпви бдбдвпви бд бдвпappleви бдappleбд бдfi бдвп fi бдappleйев в бд applefiбд ви бдйе. в в вибд бдappleбдвлбд бдapplefi бд вибдбд в fiви бд в в в бд бд appleйе илвибд бд б впappleви (R&D). в appleвибд бдви бд бд в fi бдбдвл бдapplefiйебд вибд бд б виapple в бд, appleбд йебд бдapplefi б виappleбдвк ил йев бд бдвпappleви бд в вибд бд бд бдв в вибд. в fi вибдбд в appleбдappleвп йевп бдappleв бдбд бдйе бдвпappleви в бдвп ви бдйе, appleв виfi appleбдбдfi appleвп бд ви apple бд appleбд бдв вкбд appleв в apple fi б виappleбдвк бд. в б виappleбдвк б appleapple бд EFPIA йебд бдбдвпви виappleв в вибд бд вибд бд в бд б виappleбдвк вп. б ви вп йебд в applefi бд бдви бд бдбдappleв бд бд appleбдв бдfi в ви appleви йебд appleв ви бдapplefi вибдбд бдйе бд бд appleв appleбдбд бдбдбд бд впбд appleви бдappleв ви в ви fiви бдйевив бдбдвпви бд бдвпappleви в бдвп. б бд бд appleв ви fiви еёигеё бдappleбдбд впбд 440 бд. б ви fi бд appleappleви 7 fiбд, бдвлбд бдapplefi apple йебд бдбдвпви б виappleбдвк б appleapple бд EFPIA. в в вибд бд бд бд б виapple в fi appleв apple appleви бдappleвл б виapple бд appleвив йе бд в бд в appleв бд бдappleви. в в бдвиappleбдвк вибдбд appleв apple бд бд вибд бд в бдбдйе fi бдйе бдapplefi бдвпappleви бд. б applefiв в ви: игвпв бд бдвлви (Boehringer Ingelheim б вп) Health Economics Manager в fi apple apple бд бд бдapplefi в бд: 17

18 б виappleбдвквп в бдбд бю в appleбдfi EFPIA бд в б applefiв в ви: в в б бд (Novartis) Head of Communications вт б втвив ви б виappleбдвк бюappleв бд имбдбд- ви б apple бд втви- в в (EFPIA) appleви в в впбд еёвиви, в fiв EFPIA appleбдв Dr Franz B. Humer (в fiв бд вийев втв ви Hoffman-La Roche AG). бю Dr. Humer в бд бд бдбдfiapple applefiв ви, appleви в fi бдвп appleбдfi бдбдви бдбд б виapple. б виapple вивл бд вп виfiвп apple- бдfi в бд бдбдви в вибд бд бдвпappleви, apple- бдfiбд EFPIA бд бд ви бд впбд бд бд ви б виappleбдвк б apple вп бд ви бдбдfiбд. бю виappleв йеви бд впбд apple б виappleбдвк ил влви бдвп fi бдбдви в вибд appleвп вибд бд вивпбд б виapple. в бдвп fi fiбдбд бд ви бдвп бдбдfiбд б виapple бдбдвиfi впв бд в в ви бд в впви apple вив бдйе, - в б.б. бдappleв вибд бд ви appleв в ви вив в. втбд, apple бдйе б виapple appleв ви appleв вп fi в впбд бд бд в ви applefiбд в йебдapple, apple appleв в влви влв. в в appleви в бд бд appleбдв ви бдбд бд бдв appleв бд бдвиapplefiйе apple ви fiви, appleбд- в в ви бдвпappleви йебдapple бд в appleвлви бдв ви- вп бдбдви apple- в ви- appleйебд, бдбд, бдвпappleви бдйе бд applefi бд бдв йев бдбд, apple бдбдви бдбд в apple бд appleв. в EFPIA виappleвл 4 бдв бдв бд бд в ви apple б виappleбдвк ил. бдбдвиfi впв бдв бдappleв бд fi бдвп вибд: 1. б appleв бдбд бд fi fi. 2. б бдвп бдйе бд бдв fi. 3. apple бд виfi apple вп. 4. бд fi бдв бд appleв в в бдfiви бд fi applefi, в бдвп fi б виappleбд бдйе бдappleбдвпви виapple вибд, appleви в бдв бд бд appleв в. 18

19 EFPIA Annual Meetings 2005 appleвлви fi в б appleappleв в ви Pharmaceutical Forum - в вп бд бд apple йев бд бдбдfiбд б виappleбдвк бдбдви бдбд - йебд виapple бдв бдвив бдв apple fi б виappleбд бдйе бдйе бд бд бдвпappleви бд бдбд, виappleбдвк бдбдви бдбд, бдв в вибд. илбд бдвив в бдв виapplefi, appleбдfi EFPIA бд applefiбд fiбд йебд бд: - вобд бдfiви appleвибд Innovative Medicines Initiative (IMI) - бд бд appleвибд Joint Technology Initiative (JTI). в еёигеё бд бд бдв appleбдвиappleбдвк вибдбд ви в fiви бд ви в в в бд fi ви вкбд в вибд бд бдвпappleви б виapple. в бдв appleбдв в fiви бд бд appleбдв ви бдбдвпви бд бдвпappleви в apple бдappleбд, бдfi бдвп fi бдappleйев в, appleви йевпви ви бдйе бдв бд. - вобд ви бд appleви в бд бдбд appleви в бдбд бд бдйе бд бд бд бд в бдбдви ви бдв бдв fi бд бдfiбд впбдбд. втбд appleбдбд ви в б appleappleв в ви Pharmaceutical Forum, EFPIA йебд appleйе вивп бд бд в appleбд бдвпбд ви бдбдfiбд бд ви appleйебд. - вобд ви applefiбд бдйе в, бдfi йебдapple. бю fi appleви впвлбд бд впви бдвп бдapplefi бдвп йеfi appleappleв appleв apple бд йе, в бд в впбдбд, appleви йев бюв бд бд бдвпбд (Transparency Directive). б appleappleйев, ви ви бдйе fi бд бдв в generics йебд appleв ви впви бдapplefi бдвп бдfi бдвп. - вобд виви бд в ви в бд бдбд бдfiви, бдбдви бдбд бд бд в appleви appleв appleви бд бд бд бд б виapple. б fiбд & б йе в б виapple в бд в appleвп ви вибд бд бд бдapplefi в бд в вибдfi бд бдбдfi бдбдвиfi в бд бдв в вибд. в бдбдви бдбд appleви бдвлбд в вибд бд бд бдapplefi бдappleбд в в ви бд бд б виapple бд в вибд appleappleви 18% fi appleв в илвибд бд б впappleви бд appleappleви 3,5% ви бдбд appleбдбд б виappleбдвк ил. б applefiв в ви: иг. игбдвп (Roche) Public б ffairs Officer в имбдбдбдбд бдappleбд appleappleви бдвлfiви б виapple, fiappleви виappleбдвпбд впбд appleви впвлбд в бд илвибд бд б впappleви. б appleв в ви илвибд бд б впappleви: бд в впвл applefi: бд

20 б виappleбдвквп в бдбд в apple ви бдйе бд fi вп бд вибдбдв бд впбдбд: б в бд бдвийеви в EFPIA б applefiв в ви:. б fi (Pfizer) б бд fi в бд бдйе' fiбд fi бдвп, бд в вп бдйев, йебдappleвив бдв бд бдбдвивп appleвкfiбд. apple в ви вивл б виappleбдвкfi бєв, бдви бдвп бдбдвлбд бдapplefi бд fiбдбд б.б. в б виappleбдвк бюappleв бд имбдбдви б apple бд втвив в (EFPIA) йев бд вив в вп appleв вп. б бд бдвиfi fi, EFPIA в в в бд fi apple, бдбдвп appleбд apple appleйев бдбдбд бд бд вибдбдв бд впбдбд в (6) бдвп бд: 1.appleвп бдвп applefiбд бдйе бд apple б виappleбдвк ил apple бд вибд бд бд впбдбд. 2.бд appleв apple бд в appleви в fiбд appleв apple бд бд впбдбд бдapplefi appleбдappleв appleв. 3.бд appleв apple бд appleбдйев вибд applefiбд apple бд бд впбдбд в ви бдв в ви. 4.бю бдв (regulatory developments) йебд appleв apple бд влбд виappleвпвибд в appleбд б виapple. 5.бд appleв apple бд бдбдappleвийе бд бд appleбд apple appleви йебд appleбдбдвп ви бдйе бд ви apple б виapple. 6.в втв appleбд fiви бд еёв в в бд apple бд бдappleв в бд бдви. в бд бдйе - в бдвпбд б виapple бд в ви виapple бдбдви бд fi бдв вибдйеapple вп бдйев бд виfi бдйе (в бд бдбд бдвп) виappleвпви в. йкfi, в вибд бд бд в appleв вл ви apple бдapplefi бд бдappleвлви бд apple в fi apple. бю бдв йебд appleв apple бд appleвпви, бд fi бд ви, applefiбд apple apple. 20

21 бєбдйевлбд applefiвиappleбд ви applefiбд бд в бдйе вт appleбд вивл вп apple бдвп, в бдappleйе бдвп бд бдвп (бд ви ), applefiбд бд ви fiappleви apple appleв бд apple. в бдбдбдбд б виapple виappleвл йебдвп бдвив appleбд ви applefiбд apple. б бд бдвиfi fi, EFPIA appleбдбдйев в appleбд fi бдвп applefi, бдfi бд в apple appleйев бдбдбд бд вибдбдв бд впбдбд. вт вив бд бдбдв бд виappleвп впapple бдв, apple йебд appleв apple, бдвп впapple EFPIA, бд бдfiвлбд fi б виapple. бю бдв бдвив бдбдвлви fi fi appleбдfi бдapplefi бдбдвив бд apple бд ви applefiбд. йкfi, в йебд appleв apple бд вп fi appleйе fi вибдбдвив ви бдвпви fi appleбдбдвпвл б виappleбдвк йебд (бюв бд 2001/83/б бє, fiapple appleappleйе бдapplefi бюв бд 2004/27/б бє). б applefi в бдappleбдбдв ви вивп бдбд ви впв ви бд в в бдappleбдбдви впв бд ви втимб б в fiв в бюеёб. б. бєв вп бд ви appleappleви в бдбд бюappleв бд еёбд б appleapple (в бюеёб ) в бд appleви вибд в в бдappleбдбдви впв бд ви втимб б applefiв бюб имвтб б. в. втви бд ви appleappleви бюappleв бд б бдвлв имбдбдви бд втвибд б appleбдвп б впв (бюб имвтб б ) в бд appleви вибд T в бдappleбдбдви впв бд ви втимб б бдappleв : б applefiв ви втимб б.. вовпв бд,.. б бдвиfiappleви (Boehringer Ingelheim), o б fi / ви втимб б. им. игбдбдв бд воfi втв ви. б. виappleвпйе. 21

22 б ddendum in English The Vision Ensuring a Bright Future Dionysios Filiotis General Manager PHARMASERVE - LILLY S.A.C.I. President of SFEE The vision of SFEE's Board of Directors is to make a significant contribution in maximizing benefits to the Greek citizen from the revolutionary progress in the research and development of new medicines. SFEE intends to be a decisive partner in the promotion of public health by actively contributing to the struggle against disease, a process that starts with the discovery of new medicines in research laboratories throughout the globe and is completed, after an extended period of research and development, when the patient has access to them. The maximization of the benefit to the patient, and to society, demands the creation, safeguarding, and maintenance of a contemporary pharmaceutical market. It is widely acknowledged that the pharmaceutical sector, and the Greek pharmaceutical market in general, is well organized. However, the need exists to modernize the sectoral network. With a resolute, rational, and well-planned strategy, we can upgrade the Greek system to the highest standards, to the benefit of all, and especially to the benefit of health care. Consequently, the SFEE vision to maximize benefits to Greek society from the revolutionary progress of pharmaceutical research can be summarized as the achievement of the following main goals: To provide immediate access by patients to all medicinal products, especially to new medicines. The delay of access to new medicines has significant impact on the patients' quality of life, and can affect patient survival rates. To ensure the highest quality of all medicinal products in the market. Only branded medicinal products can guarantee quality. To ensure sound financial management of social security funds at all levels by fully implementing an advanced IT infrastructure and electronic communication. To strictly comply with Code of Ethics provisions in all phases of the distribution and promotion of medicinal products. To reinforce and support a well-run supply chain. The achievement of these goals establishes the credibility of SFEE as a partner of the State. 22

23 of Sfee б ddendum in English for Patient Healthcare 1Immediate Access to Medicines, Immediate Access to Therapy Patient access to medicines is dramatically influenced by the policy followed and implemented by the State. Access is also influenced by the financial management of the healthcare system and by the operation of the supply chain. Following the introduction and enforcement of the Law on the Pharmaceutical Care System Reform and the final abolition of the Reimbursement List, all prescription only medicines are covered by social insurance funds. However, the abolition of the List does not ensure direct access by patients to all medicinal products. Moreover, direct access to new medicines depends on the State's consistency to issue Price Lists in the time limits predefined by the law. Community and national legislation state that all price setting procedures must be completed within 90 days. Until recently, there were huge delays in Greece, up to 19 months. In addition, the last price bulletin was issued with a -four months- delay. Today, however, a strong effort is being made, for the first time, to achieve a total delay period of up to 90 days for price setting and reimbursement by social insurance funds. International and Greek experience have shown that the reduction of time needed to set prices, in combination with the approval of rational increases in the prices of medicines, ensures to a great extent: a. Immediate access of patients to all medicinal products, since the approval of rational increases limits the re-exportation of imported medicines and results in minimizing shortages of medicines in the market. b. Continuation of the marketing of well established and inexpensive medicines, since by readjusting their price they are not withdrawn from the market or replaced by medicines with double the price. Thus, the rise of pharmaceutical expenditure is contained. Immediate access to medicinal products presupposes a responsible approach by the State 2regarding the timely issue of price bulletins. Quality of Medicinal Products SFEE's vision is complemented by the effort to: Ensure the highest, identifiable quality of all medicinal products in Greece through the marketing of branded original medicinal products and branded essentially similar products, and to ensure that the decision for prescribing these products under their trade name is taken solely by a physician. Regarding the paramount issue of quality it should be stressed that medicinal products must comply with the most strict quality criteria. Only medicines with a brand name meet these criteria. The physician responsible for the treatment to be followed must be the professional who decides which medicine to prescribe. No physician should prescribe 23

24 б ddendum in English 3 medicines by the name of the active ingredients. He/she must always prescribe medicines by their brand name to avoid exposing patients to medicines of inferior quality and effectiveness. If a physician is forced to prescribe using the name of the active ingredients, subsequently not knowing exactly which medicinal product will be administered to the patient, he/she would prescribe a newer original medicinal product which has not been copied and is in general more expensive. The conclusion is that the choice of prescribing medicines by the name of the active ingredients may increase pharmaceutical expenditure and at the same time downgrade the quality of healthcare. Sound Financial Management of Social Security Funds and Hospitals The goal of direct access to all medicinal products depends to a great extent on the proper financial management of social insurance funds and hospitals. This can only be achieved through a comprehensive technological modernization and a thorough upgrade of the IT infrastructure. The conditions are ripe for Greece to acquire a technologically advanced administrative and organizational infrastructure of its social insurance funds and hospitals that, in addition to providing direct access by patients to medicines, will reduce corruption phenomena and waste of resources, which now amounts to almost 20% of the total pharmaceutical expenditure. SFEE's vision is to cooperate with the State in finding solutions for the sound financial management of social insurance funds and hospital funds, to participate in the build-out 24

25 Editorial 4 5 of the IT infrastructure by providing knowhow, and to submit proposals aimed at avoiding the waste of financial resources. In short, SFEE is developing a new philosophy for a prompt and proper pricing policy in combination with the system's technological modernization, two initiatives that can maintain and even reduce pharmaceutical expenditure as a percentage of GDP, achieving at the same time a vertical improvement of health care quality. Good Promotion Practice SFEE aims to provide objective, unbiased, and scientifically sound information, and to train health professionals within the guidelines of the SFEE Code of Practice. SFEE promotes providing information and training to healthcare professionals related to the scientific progress that every new medicine represents. A new medicine is the result of many years of research. It can save lives or improve the quality of life of citizens. This is why the correct term to use is б provision of scientific informationб rather than б advertising.б Flawless Operation of the Supply Chain Direct access by patients to all medicinal products is undoubtedly influenced by the supply chain. SFEE's vision is to participate actively in the effort to ensure the unhindered operation of the supply chain in the Greek State, to control the re-exportation of medicines, and to develop local production. SFEE's priority is to ensure an adequate supply of medicinal products in the Greek market. Furthermore an increase of domestic production will positively contribute to the creation of new jobs and the development of the national economy. Medicines Constitute an Investment in Human Welfare and Society Pharmaceutical expenditure is an investment in human welfare and society. A new, advanced therapy may be more expensive, but through the administration of a specific medicine, the patient may avoid surgery and the duration of hospitalization may be reduced or eliminated. Therefore, the total cost of a new, more expensive pharmaceutical therapy is counterbalanced by the benefits it provides to a patient's quality of life and from the saving of resources from other health care forms (hospitalization). New therapies extend the healthy, productive life of citizens. The benefit to citizens and society from the progress of pharmaceutical research is above and beyond the cost of new therapies. Within this framework, with explicit principles, with decisiveness, and with specific actions and initiatives, SFEE can make a significant contribution in maximizing the benefits to the Greek citizen brought on by the revolutionary progress of pharmaceutical research. The Board of Directors of SFEE, with vision and systematic work, will cooperate with the State to solve the existing problems and will contribute actively to bringing this future, full of hope, day by day, closer to every citizen. 25

26 б ddendum in English Greece cuts off-patent medicine prices by 20% For the first time, the prices of off-patent proprietary medicines have been cut in Greece, following the publication of the latest price bulletin. The bulletin, the first to be issued under new Greek pricing legislation, was published on November 10th. However, it has come under fire, not only for being four months late but also for "selectively" observing the new pricing regulations with respect to price adjustments. According to the new legislation, proprietary medicines whose patents have expired will now be subject to a 20% price cut one year after the marketing of a generic version. 181 such reductions were applied to proprietary drugs in this bulletin. In all, just over 1,000 prices were published, of which 153 were for new proprietary medicines and 567 for generics. There were 210 price cuts and 185 price increases ranging from 10-50%. However, industry has complained that although the reductions have been implemented, price increases in line with the new regulations were not so readily forthcoming. Despite a plethora of applications by pharmaceutical companies for price increases to existing products under the new system, only 185 products, primarily cheaper medicines, were granted increases. Moreover, the increases that were made appear not to have been calculated in line with the principles of the new system, which is based on the average of the three lowest prices in the EU (two from the former EU 15 plus Switzerland and one from the 10 countries that joined the Community in 2004). In a press release, the pharmaceutical industry body, the SFEE, described the application of the new pricing regulations as "selective", saying that this damaged the interests of pharmaceutical companies, and that the reductions were excessive. The SFEE said that a large number of older cheaper products had not had their prices increased even though this was required under the new pricing legislation. Moreover, increases that had been granted were less than those provided for under the new pricing system. As in most countries, pharmaceutical expenditure is a politically sensitive issue in Greece. The ministry of development said that the overall impact of the price changes on the social security funds was positive to the tune of Euro27 million a year Euro(51 million in price increases offset by Euro78 million saved on reductions). Moreover, if the impact of the new 4% rebate to the social security funds was added, the ministry said, the funds stood to gain a total of Euro107 million from the changes made to date under the new system. The Minister of Development described the price increases granted in the bulletin as logical and said that pharmaceutical expenditure would have risen by Euro190.5 million if all the applications (around 650) for price increases to existing products had been granted. 26 Of course, the workload involved in processing such a large number of applications could also be a factor in the authorities' decision not to make all the adjustments in one bulletin. It remains to be seen how soon new bulletins will appear and whether, and at what rate, further price adjustments to existing products will be made. Article published in Scrip November 24th, No 3212 p 6

27 Increased Seizures of Counterfeit Medicines in Europe Highlight the Need for Patients to Purchase their Medicines through Certified Distribution Channels Brussels, 10 November The European research-based pharmaceutical industry today reacted to the announcement made by the European Commission (DG TAXUD) (1) that "more than 500,000 counterfeit medicines were seized at the external borders of the EU in the year 2005" and that "the increasing use of internet to sell fakes (mainly medicines) increases the challenge customs face". In support of EU Taxation and Customs Commissioner Laszlfi Kovacs' plan for action, Dr Thomas Zimmer, chair of EFPIA's Anti-Counterfeiting Working Group, stressed that the growing and increasingly dangerous phenomenon of fake medicines now affecting Europe was a global problem requiring collective actions: "The scourge of counterfeit medicines reinforces the need to tightly secure the entire pharmaceutical supply chain in Europe as international traders take advantage of more open borders and new technologies (Internet) to conduct their criminal business without any scruple for people's health. By all means, patients must be encouraged to purchase prescription medicines through authorised distribution channels only!" Public private partnership with all key stakeholders at local, national ad international level is essential to effective collaboration. Dr Thomas Zimmer recalled that whereas the primary responsibility for the prevention and control of counterfeiting lies with national authorities and international organisations, the pharmaceutical industry is actively committed to combating counterfeit medicines with the primary objective of protecting patient health. Against this background, EFPIA broadly supports the new commitment taken by the international community to step up the fight against counterfeit medicines. In the case of pharmaceuticals, however, the industry believes that it would be preferable, in disclosing custom seizures, to mention the products seized by therapeutic category. Adding a company name or a specific product name is not needed as it may create undue scare with the general public about the healthcare system. EFPIA's white paper on the anti-counterfeiting of medicines is available at: Frequently Asked Questions about counterfeit medicines: Combating counterfeit medicines and protecting patients through a partnership approach: 1. Press Release from DG Taxation and Customs Union: Customs: Commission publishes 2005 Customs seizures of counterfeit goods (10 Nov. 2006) 27

28 б ddendum in English The Innovative Medicines Initiative Launches New Website б new interactive, state-of-the-art website to mobilise participation in the Innovative Medicines Initiative (IMI) across Europe was launched by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The URL: The Innovative Medicines Initiative is a unique pan-european public and private sector collaboration between: patient organisations, universities, hospitals, regulatory authorities as well as small and large biopharmaceutical companies. The objective of IMI is to support the faster discovery and development of better medicines. The website is designed to enhance communication and information flow between everyone involved in biomedical research across Europe. The new website enables patients, all researchers and regulators to learn more about the progress of IMI, its events and organisation. These groups of stakeholders will also be able to ask questions about IMI directly, giving them a voice in shaping future biomedical research in Europe. Octavi Quintana Trias, Head of Directorate F Health at DG-Research of the European Commission said, б The Innovative Medicines Initiative is key to developing a dynamic and innovative knowledge based economy in Europe and this excellent website moves us forward towards this goal. The Commission is looking forward to starting the implementation of the Innovative Medicines Initiative together with EFPIA and the Member States as soon as possible.б Jonathan Knowles, Chair of the Research Directors' Group of EFPIA said, б This website is an excellent communication resource for scientists and patients who are planning to participate in the Innovative Medicines Initiative. The members of the EFPIA Research Directors' Group are eager to start implementing Patient Centred Projects the moment we get the green-light from the EU.б Creating biomedical R&D leadership for Europe to benefit patients and society is the vision of IMI, which is a powerful strategic partnership between the European Commission and EFPIA, who are supporting the Innovative Medicines Initiative with strategic and financial resources. About the Innovative Medicines Initiative (IMI) IMI is a unique pan-european public and private sector collaboration between large and small biopharmaceutical and healthcare companies, regulators, academia and patients and represents a coordinated joint public and private collaboration to boost Europe's biomedical R&D base, correcting the relative under-funding of biomedical R&D in Europe compared to other regions of the world. The aim of IMI is to support the faster discovery and development of better medicines for patients and enhance Europe's competitiveness by ensuring that its biopharmaceutical sector remains a dynamic hightechnology sector. IMI will ensure that Europe's biopharmaceutical sector receives targeted strategic support for the benefit of patients, scientists and citizens of Europe. IMI proposes a number of clear, practical paths that will accelerate the discovery and development of more effective innovative medicines with fewer side-effects. IMI will implement innovative patient centred research projects that address the principles causes of delay or bottlenecks in the current process of discovering and developing new medicines through powerful public-private collaborations. These bottlenecks have been identified as predicting safety, predicting efficacy, bridging gaps in knowledge management and bridging gaps in education and training. The Strategic Research Agenda, a living document and will be up-dated based on scientific advances, describes the recommendations to address these bottlenecks and provides a plan to guide their implementation. 28 Enhanced European Competitiveness: The Innovative Medicines Initiative is important for Europe because it contributes to the European Union's Lisbon Objective of building the most competitive and dynamic knowledge-based economy in the world by 2010;

29 б ddendum in English The Innovative Medicines Initiative is important for Europe because the scientific challenges facing Europe are too complex for organisations to address in isolation. Therefore pan-european public and private sector collaboration and co-ordination is essential to ensure that patients benefit from advances in biotechnology, such as the decoding of the human genome; The Innovative Medicines Initiative is important for Europe because it secures longterm prosperity for Europe through biotechnology, which the European Union considers to be essential for developing a dynamic and innovative knowledge based economy. Distinct Benefits for Patients, Scientists and Europe: Faster discovery and development of better medicines will benefit patients; A more attractive professional environment will benefit scientists, addressing the brain-drain; The creation of European expertise and know-how in new technologies will attract biomedical R&D investment in Europe; The creation and support of sustainable competitive advantage for Micro, Small and Medium-Sized Enterprises (SME), spin-offs and start-ups will enhance Europe's economy. Implementation To fully implement IMI would require an investment of about _460 million per year for an initial seven year period, starting in 2007, shared between the European Commission and the European Federation of Pharmaceutical Industries and Associations. A potential overall injection of over _3 billion of new funding to boost Europe's science base and stimulate the faster discovery and development of better medicines. As part of the European Union's 7th Research Framework Programme, IMI will be proposed for Joint Technology Initiative status - subject to approval by the European Competitiveness Council in The European Commission and European Federation of Pharmaceutical Industries and Associations will take joint responsibility for creating and operating a new international notfor-profit organisation based on article 171 of the Treaty establishing the European Community. This organisation will have a legal mandate to award significant research grants to European Public-Private Collaborations to conduct innovative patient centred research projects focused on the principal causes of delay or bottlenecks in discovering and developing new medicines. The European Union's 7th Research Framework Programme will fund academic and public sector participants of Public-Private Collaborations and support SMEs. Biopharmaceutical companies will fund their own contributions to 100%. Other types of organisations participating in Public-Private Collaborations will be supported on a case-bycase basis. The biopharmaceutical industry partner(s) will match the funds from the European Union's 7th Research Framework Programme with R&D resources such as staff, laboratories, materials and clinical research capabilities. About EFPIA and the Research Directors Group (RDG) The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the research-based pharmaceutical industry operating in Europe. EFPIA's Research Directors' Group (RDG), in which European Biopharmaceutical Enterprises (EBE) - a specialised group within EFPIA - also participates, brings together the European heads of research from the world's leading pharmaceutical companies to address the issues facing research and development of (bio)pharmaceuticals in Europe. 29

30 б ddendum in English Paediatric Medicines Press release Council of the European Union 1. Directive 2001/83/EC (OJ L 311, , p.67), as last amended by Directive 2004/27/EC (OJ L 136, , p. 34). 2. Directive 2001/20/EC (OJ L 121, , p. 34). 3. Regulation (EEC) No 1768/92 (OJ L 182, , p. 1), as last amended by the Act of Accession Regulation (EC) No 726/2004 (OJ L 136, , p. 1). 5. Directive 2001/20/EC (OJ L 121, , p. 34). The Council, by approving all amendments to the Council's Common Position voted by the European Parliament, adopted the EC Regulation on medicinal products for paediatric use and amending Council regulation (EEC) No 1768/92, Directive 2001/83/EC and Regulation (EC) No 726/2004 (PE-CONS 3623/06, doc /06 ADD1). The regulation aims to improve child health, by increasing the availability throughout the Community of medicinal products that have been appropriately tested and authorised for paediatric use, while removing obstacles to intracommunity trade in paediatric medicinal products. The regulation aims in particular to meet the following objectives: - to ensure that medicinal products used to treat children have been the subject of ethical high-quality research and appropriate clinical trials; - to ensure that those medicinal products are duly authorised; - to improve information on the use of medicinal products intended specifically for children and transparency on paediatric clinical trials; while avoiding unnecessary clinical trials on children and delays on the authorisation of medicinal products for other age populations. To that end, the regulation contains a combination of obligations and incentives. The main obligation created by this Regulation is that either the results of clinical studies in accordance with a paediatric investigation plan, or proof of having obtained a waiver for medicines that are of no paediatric use, must be submitted as part of the procedure for obtaining marketing authorisation. For medicines protected by a patent or an SPC, incentives are provided through the extension of exclusive rights. The regulation also aims to certify a safe use of off-patent medicinal products for treatment of children, through the introduction of a new type of marketing authorisation for off-patent medicines that have been appropriately tested for paediatric use, the PUMA, as well as through provisions on funding of research into the appropriate use of off-patent medicinal products for paediatric treatment. A scientific committee, the Paediatric Committee, is created within the European Medicines Agency, with expertise and competence in the development and assessment of all aspects of medicinal products to treat paediatric populations. The proposed system covers medicinal products for human use within the meaning of the directive on the Community code relating to medicinal products for human use 1 and is in full compliance with the EU clinical trials directive 2. In order to fulfil its objectives, the new regulation also introduces some amendments to the regulation that created a supplementary protection certificate for medicinal products 3, the directive on the Community code relating to medicinal products for human use, the regulation laying down procedures for the authorisation and supervision of medicinal products 4 and the EU clinical trials directive 5. 30

31 The Board of Directors of SFEE President Dionysios Sp. Filiotis PHARMASERVE - LILLY S.A.C.I. б ви втвибд appleapple Newsletter вт. игвп вийев бд втв бд игв : иг. игбдвп (ROCHE) в. б бд (NOVARTIS). б fi (PFIZER) M. бдвлви (BOEHRINGER-INGELHEIM) в. игбдвпбд (втимб б ) б appleв бд илв : вт. игвп втв в имбдбдви б apple б впв б. бдв б ви 30 & игвп б бд, бдвпв.: , Fax: Internet: [email protected] Hellenic Association of Pharmaceutical Companies 30, Vassileos Georgiou Ave. & Mikras Asias, Halandri, Athens-Greece Tel.: , Fax: Internet: [email protected] Vice Presidents Pascal Apostolides ABBOTT Laboratories Hellas S.A. Marcos Gerassopoulos SANOFI-AVENTIS S.A. Takis Zervakakis WYETH Hellas S.A. George Katzourakis GLAXOSMITHKLINE S.A. Constantine Bantzis UCB Pharma S.A. Vassili Niadas CANA Laboratories S.A. Secretary General Katherine Karella PFIZER Hellas S.A. Treasurer Kostas Evripides GENESIS Pharma S.A. Members Spyros Varthalis NOVARTIS Hellas S.A. Panagiotis Gerolymatos P.N. GEROLYMATOS S.A. Marios Katsikas Fб Rб во S.A. Stan Kollias ASTRAZENECA S.A. George Constantelis BRISTOL MYERS SQUIBB б Pб George Moutousidis CHIESI Hellas S.A. 31

32 б бєбювтб еёвт: