Today, the European Commission published its proposal to amend Regulation (EC) No 469/2009 on SPCs to introduce a manufacturing waiver, i.e. an exception to allow manufacturers of generics and biosimilars to manufacture certain pharmaceuticals for export outside the EU during the SPC term. A copy of the proposal is available here.
The results of the studies on the legal aspect of SPCs by the Max Planck Institute (here) and on the economic impact of SPCs, pharmaceutical incentives and rewards in Europe by Copenhagen Economics (here) were also published on the Commission website today.
The results of the studies on the legal aspect of SPCs by the Max Planck Institute (here) and on the economic impact of SPCs, pharmaceutical incentives and rewards in Europe by Copenhagen Economics (here) were also published on the Commission website today.
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