Medicines for Europe calls for change to manufacturing rules in EU

30 November 2018

Medicines for Europe, a group representing the European generic and biosimilar industries, has called on regulators to “make the SPC manufacturing waiver a success for Europe.”

Supplementary Protection Certificates (SPC) in the EU extend the market exclusivity provided by patents by up to five years, and can be used to protect branded medicines from generic competitors.

Under current rules, EU-based manufacturers of generic and biosimilar medicines are not allowed to produce medicines protected by an SPC, even if they are designed for export to non-European markets where no such protection exists.

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