EU generics industry welcomes vote on SPC manufacturing waiver

23 January 2019

Medicines for Europe, a trade group representing the generic and biosimilar industries across Europe, has welcomed a vote in the European Parliament supporting a comprehensive SPC manufacturing waiver.

The European generics industry has long campaigned for a change to the SPC, a certificate that allows drugmakers to extend the 20-year patent protection on their medicines by an additional five years.

EU-based firms currently cannot produce generic or biosimilar versions of these medicines for sale in the EU during that time, neither can they export them outside the EU, or produce and stockpile them in advance of SPC expiry.

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