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Reportlinker Adds Russia Pharmaceutical Market Overview Pharma Companies Target Russia Despite the Challenges it Presents
Date:12/8/2010

New Federal Law on Circulation of Medicines attracts criticism 58

Regulation process now less costly but time taken to register a drug is increasing 58

Russia's manufacturing facilities will need to align with international GMP standards 59

Domestic clinical trials were to be required as a registration prerequisite under the new law 59

New law lacks orphan drug clause 59

Additional new provisions 60

Russia - Intellectual property environment 61

There are two ways of obtaining patent protection in Russia 61

Enforceability of patent laws is still weak and data exclusivity remains an unresolved issue 61

Drug counterfeiting is an ongoing problem but there are few recent developments 62

Drug importation - new law streamlines import procedures 63

Russia - Pricing and reimbursement 64

Russia is looking to its Essential Drug List to contain costs 64

Pricing issues - the government is increasing its controls 66

New Essential Drug List compiled in 2009 66

Mandatory state registration of maximum prices replaces voluntary system 66

Reimbursement issues - Introduction of the federal reimbursement system DLO was a major change 68

Supply and deficit problems have historically hampered the DLO's success 69

DLO was modernized again and split into two procurement branches 70

Centralized program covers seven expensive-to-treat diseases 70

ONLS program covers remaining drugs 70

Oncology drugs had the highest sales volume in the DLO 71

Ongoing issues regarding the DLO program 71

4. Russia - Pharmaceutical sales analysis 72

Russia - Key findings 72

Pharmaceutical market size 72

Leading therapy areas 72

Leading pharmaceutical brands 72

Leading pharmaceutical companies 72

Russia - Pharmaceutical market size 74

Russia - Leading therapy areas 76

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