Global medicines spending is expected to shift toward generic drugs, with an expected rise from 27% in 2012 to 36% of total sales by 2017, according to a Commission staff working document that accompanied the EU executive’s 2015 Single Market Strategy Communication,.
“Generics and biosimilars could represent 80% of the volume of medicines by 2020,” the document reads.
The Commission announced its intention to add a manufacturing waiver to supplementary protection certificates (SPC) as part of its upgraded Single Market Strategy in 2015.
An SPC is an intellectual property right that serves as an extension of a patent right in the EU. With a manufacturing waiver, generic drugs makers can manufacture SPC-protected drugs in the EU to sell in other markets, and to prepare stocks for when the SPC expires.