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Reportlinker Adds Pharmaceutical Key Trends 2011 - Healthcare System and Drug Regulatory Overview: Cost-containment and regulatory pressures intensify
Date:4/28/2011

p>Regulatory changes have a largely negative impact on pharma

Heightened safety concerns continue to impact pharma

Collaboration between the FDA and EMA is intensifying

EU ban on direct-to-patient communication guidelines partially relaxed

Developed markets exhibit a stable intellectual property environment

It is generally easier to secure patent protection in the US than in the EU

The EU follows the 8+2+1 rule

Japan gives branded pharma companies 8 years of data exclusivity through re-evaluation requirement

Springboarding allows generics manufacturers to access branded drug data in Australia

Loss of Plavix exclusivity in Germany is thought to be an exception

The EU's move to a single patent has been held up

The intellectual property environments in the emerging markets are seen as inadequate

Russia's intellectual properly environment is characterized by corruption

Patent reviews are slow in Brazil

Indian law does not contain statutory data protection

China is not yet affording adequate data protection for new chemical entities

PRICING AND REIMBURSEMENT

Key global pricing and reimbursement controls

Pricing controls

Reimbursement controls

Pricing and reimbursement cuts were key elements included in austerity measures in many developed markets

Patent-protected drugs are spared by Italian price cuts but off-patent and generic drugs suffer

Austerity measures in France impact both prices and reimbursement rates

Spain's price cuts impact both branded and generic medicines

Germany's new law focuses on containing the growth of spending on patent-protected drugs

Australia's changing reimbursement landscape puts pressure on local generics sector

Japan continues to focus on drug price cutting as its main cost-containment measure

US pharma companies are impacted by higher rebates and discount
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