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How Broad Labels May Make Market Access In Germany More Difficult

 
• By Francesca Bruce

Companies might have to rethink their German market access strategies if new legislation is passed to informs doctors of the outcome of AMNOG benefit assessments.

Doctor consulting

Germany, Europe’s biggest market, could get tougher thanks to possible legislation changes that would inform doctors about the results of AMNOG benefit assessments. Companies will need to plan market access strategies much earlier and may have to consider whether having a broad label in Germany is a help or hindrance to market access, say experts. Companies might even eventually think about whether decentralized marketing authorizations could be a better approach to meeting the needs of different EU member states.

According to a new law likely to be passed in the next couple of months, existing information systems will inform...

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