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Germany clashes with other EU states on pharma regulation overhaul

Berlin warns shortening time before generic drugs are allowed to market will stifle industry investment

Germany and several smaller member states have mounted opposing last-ditch lobbying efforts over EU pharmaceutical legislation to be published next week, with Berlin warning that it would damage investment by the drug industry.   

The overhaul of pharma legislation is the most significant for 20 years, prompting an outcry from drugmakers who fear the EU will cut exclusivity protection from 10 to eight years, while allowing them to win back the two years by jumping over new hurdles.

In a position paper seen by the Financial Times, Berlin argues that the EU must be “innovation-friendly”, and that a requirement to launch medicines across all member states within two years to gain an extra year of market exclusivity, poses “considerable risks” to the industry.

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