EU Regulatory Reforms Mean Many Orphan Drug Producers Won’t Benefit From Incentives
The EU’s regulatory reform package if unchanged could make orphan drug development less attractive, warn industry representatives.
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The European Commission’s proposals to overhaul the EU pharma legislation, which will see some orphan drug incentives cut, would cause a “significant dip in innovation,” according to number crunching from pharma industry association EFPIA.
A German civil court has ruled that pharma firms can enforce market exclusivity rights for orphan drugs by taking legal action against competitors. Lawyers say this decision, which relates to Alexion’s Soliris, is the first of its kind and will likely have a wider impact across the EU.
The European Commission will have a fight on its hands when it comes to the data protection part of its proposals for EU pharma legislative reform.