SPC manufacturing waiver moves closer

18 September 2018

A proposal to fix a side effect of Europe’s Supplementary Protection Certificate (SPC) has taken a step closer to introduction.

The SPC is an incentive that extends the protection of patented medicines by up to five years to compensate for the time lost in obtaining regulatory approval of the drug. During this period, European manufacturers of generics and biosimilars cannot produce their medicines in the European Union.

To address this issue, the proposed SPC Manufacturing Waiver allows developers of generic and biosimilar medicines to produce during the SPC period in order to supply unprotected markets as soon as possible after protections expire.

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