Recent Study: Germany Pharmaceuticals & Healthcare Report Q4 2013

BMI View: The Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) legislation will constrict drug companies' revenue-earning opportunities in Germany. While the law has focussed on the regulation of the pricing of newly approved drugs relative to their benefit over already-existing therapies - hitting companies hard - the government is now clamping down on prices set by drug companies back in Germany's free pricing era.

Headline Expenditure Projections

* Pharmaceuticals: EUR38.89bn (US$49.39bn) in 2012 to EUR37.93bn (US$50.45bn) in 2013; -2.5% in local currency terms and 2.2% in US dollar terms.
* Healthcare: EUR291.82bn (US$3970.61bn) in 2012 to EUR297.32bn (US$395.43bn) in 2013; +1.9% in local currency terms and +6.7% in US dollar terms.

Full Report Details at
- http://www.fastmr.com/prod/670999_germany_pharmaceuticals_healthcare_report_q4_2013.aspx?afid=303

Risk/Reward Rating: In BMI's Q413 Pharmaceutical Risk/Reward Ratings, Germany has an RRR score of 71.9 out of 100, making it the second most attractive pharmaceutical market in the Western European region, which covers 13 key markets.

Key Trends And Developments

* In late June 2013, Eisai announced its decision to suspend the commercial distribution of its antiepileptic drug, Fycompa (perampanel) in Germany based on its belief that the German Federal Joint Committee (G-BA) had failed to appropriately assess the value of Fycompa as an innovative treatment in an additional benefit assessment conducted after German marketing approval was granted for the drug in July 2012. The G-BA concluded in March 2013 that the submitted assessment data comparing perampanel to lamotrigine or topiramate was insufficient and that the additional benefit of perampanel was thus unproven.
* The latest PhRMA submission to the 2013 Special 301 report by the US Trade Representative (USTR) holds mixed results for countries from Western Europe. Portugal has been placed on the Priority Watch list, while Finland, Germany, Italy and Spain have been included on the Watch List. PhRMA's submission to the USTR outlines the industry's concerns about countries' IP regime deficiencies, including adherence to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), measures in place to deal with counterfeit medicines, the speed at which IP disputes are resolved and general market access barriers.

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