in vrsac, serbia russian pharmaceutical market. prospects ... · kagocel clexan copaxone teva...
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10th traditional Symposium in Vrsac, Serbia
Russian Pharmaceutical Market.
Prospects for the Development of Cooperation Between Russian and Serbia Between Russian and Serbia
Victoria V. PresnyakovaAssociation of the Russian
Pharmaceutical Manufacturers
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Russian Pharmaceutical Market
• Population –
142,9 mln142,9 mln
• Territory –
17 098 246 km²
• Volume – 20,7 bln $ (2013, trd price ,drugs)
– 7.6 bln $ (1 H 2014,trd price)
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Russian Pharmaceutical Market
Local manufacturers
more than 480
Local manufacturers
more than 480
20,7 20,7
Foreign manufacturersmore than 1000
3
Pharmacy Pharmacy Pharmacy Pharmacy more than 62 000
20,7 20,7 BlnBln. $. $
Distributors2 618
Hospitalsmore than 49 000
Hospitalsmore than 49 000
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Pharma market growth in 2013
654
441
608
400
5,0
4,2
5,2
4,4
Hospital
Retail
Value Volume
+7,5%
10%
-4%
-4%
SALES BY VALUE, RUB BLN
SALES BY VOLUME, BLN PACKS
Growth rate fell out of double digit in 2013 with hospital sector stagnation
Indicator RUB $ EURO Packs
Value 2013, Bln. 654 20.6 15.5 5.0
Growth 2013 7% 5% 2% -4%
2013
86
127
2012
80
128
2013
0,10,6
2012
0,10,7
Reimbursement
Hospital
8%
-1%
-2%
-4%
SALES BY VALUE, RUB BLN
SALES BY VOLUME, BLN PACKS
Source: IMS Health. TRD prices
4
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TOP 10 COMPANIESH1 2014 (total)
Rating Company
1 SANOFI-AVENTIS
2 NOVARTIS (inc. SANDOZ)
3 ROCHE
4
Source: IMS Health
4 PHARMSTANDART
5 JOHNSON & JOHNSON
6 TEVA
7 BAYER HEALTHCARE
8 NYCOMED/TAKEDA
9 SERVIER
10 MERCK SHARP DOHME
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TOP 10 COMPANIESH1 2014
Commercial Hospital reimbursement
NOVARTIS (inc. SANDOZ) SANOFI-AVENTIS ROCHE
SANOFI-AVENTIS GLAXOSMITHKLINE JOHNSON & JOHNSON
PHARMSTANDART ROCHE TEVA
BAYER HEALTHCARE MERCK SHARP DOHME SANOFI-AVENTIS
Source: IMS Health
BAYER HEALTHCARE MERCK SHARP DOHME SANOFI-AVENTIS
SERVIER NOVARTIS (inc. SANDOZ) BAXTER INT
NYCOMED/TAKEDA NYCOMED/TAKEDA PHARMSTANDART
TEVA ABBVIE LABORATORIO TUTEUR
MENARINI JOHNSON & JOHNSON NOVO NORDISK
GEDEON RICHTER ASTRAZENECA ASTRAZENECA
ABBOTT BAYER HEALTHCARE OCTAPHARMA
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TOP 10 top of 10 trademarksH1 2014
Commercial Hospital Reimbursement
ESSENTIALE N NATRIUM CHLORIDUM MABTHERA
ACTOVEGIN KALETRA VELCADE
KAGOCEL CLEXAN COPAXONE TEVA
ALFLUTOP HERCEPTIN COAGIL-VIIALFLUTOP HERCEPTIN COAGIL-VII
LINEX CUROSURF GENFAXON
EXODERIL ULTRAVIST LANTUS SOLOSTAR
CONCOR GLUCOSE RECOMBINATE
ARBIDOL FRAXIPARINE REMICADE
MEXIDOL PREZISTA HERCEPTIN
CARDIOMAGNYL MEROPENEM REBIF 44
Source: IMS Health
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Custom Union
BELARUSSIA
Population – 9,4 mln
Territory– 207,6 thsd m²
Commercial Pharmmarket (value) -701 mln $
KAZAKHSTAN
Population – 17 mln
Territory–2,724 mln. km²
Commercial Pharmmarket(value) -953 mln $
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Legislation
• Federal Drug Law 2010(on circulation of medicines)
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Regulatory questions
I R&D (GLP)
II MANUFACTURING (GMP)
III CLINICAL TRIALS (GLP)
IV DISTRIBUTION (GDP)IV DISTRIBUTION (GDP)
V PHARMACY (GPP)
VI PHARMACOVIGELANCE
(GVP)
VII INFORMATION (GIP)
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GXPG
L
PG
C
P
C
G
M
P
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PHARMACOVIGILANCE
• FEDERAL PHARMACOVIGILANCEPHARMACOVIGILANCECENTRE
• REGIONAL MONITORING CENTRES
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PHARMA-2020 STRATEGY
The Development Strategy for PharmaceuticalIndustry of the Russian Federation for the perioduntil 2020 adopted in 2009
• I step:2009-2012 IMPORT • I step:2009-2012 IMPORT SUBSTITUTION
• II step:2013-2017 LOCALIZATION
• III step:2018-2020 innovation
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Association of the Russian pharmaceutical manufactures
ARPM unites about 20
pharmaceutical plants ARPM
GMP
14
All Russian regions: Moscow, St.
Petersburg, Nizhniy Novgorod, the Urals, Siberia and the Far
East
Market share in Russia makes more than 50%
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HARMONIZATION
• Registration
• Clinical trials• Clinical trials
• Standardization
• Pharmacovigilance
• OTC
• Counterfeit medicine
ICH
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Promotion and Advertising
ОТС
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Государственный надзор в сфере обращения ЛС
Регулирование информации и рекламы ЛС
Complex regulation
of advertising of medicines
надзора в области соблюдения норм честной конкуренции
защиты прав потребителей
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Ethics of public advertising in Pharmacy
Do No Harm =Not deceive =Do not enter into temptation !!!
Federal Law "On Protection of Consumer Rights" from 17.12.1999
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Legislation
• Federal Law on advertising 2006
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Дополнительные запреты
• наркотические средства, психотропные вещества и их прекурсоры отнесены к товарам, реклама которых запрещена (п.2 ст.7) (это не относится, естественно, к лекарственным средствам, содержащим эти вещества: они могут содержащим эти вещества: они могут рекламироваться для специалистов здравоохранения – ч.9 ст. 24).
• запрет в рекламе на указание на использование эмбриональных тканей при производстве рекламируемого продукта (п. 5 ч.5 ст.5).
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Обязательные требования (Часть 7 статьи 24)
!!!
Предписано в рекламе предупреждать о необходимости ознакомления с инструкцией по применению или получения консультации специалистов, о наличии противопоказаний к применению и использованию лекарств.
Установлено время, которое должно быть уделено такому предупреждению, и площадь рекламного пространства для разных рекламораспространителей. Предусмотрено, что в телепрограммах предупреждение должно быть не только визуальным, но и озвученным.
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Main idea
Продукты питания
БАД
Лекарственные
средства
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Продвижение на специалистов
�Прямая реклама
�Медицинские представители
�Информационные мероприятия для
продвижения препаратовпродвижения препаратов
�Бесплатные образцы – в РФ с 2013 г.
�Спонсирование, бонусы и поощрения
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Legislation
• On Advertising"
• "On the basis of health protection in the
Russian Federation" Russian Federation"
• "Federal Drug Law 2010
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Кодекс AIPM - нормы взаимодействия с
юридическими лицами либеральнее, чем с
физическими персонами
Кодекс разрешает:
• неимущественные пожертвования и пожертвования лекарственных препаратов некоммерческим организациям (по запросу организации и по безналичному расчету), организации и по безналичному расчету),
• гранты для поддержки медицинского образования,
• в виде подарков врачам –- изделия, полезные в медицинской практике (Items of MedicalUtility).
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Partnerships
• EMA
• FDA• FDA
• FDA (China)
• FDA (India)
• PIC/S
• Associations and unions
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Partnerships in Region
• Population
• History
• Culture• Culture
• Traditions
• Experience
• Wishes
• Gold Brains and Hands