The European Commission proposes export manufacturing waiver
On 28 May 2018, the European Commission published a proposal to amend Regulation (EC) No 469/2009 on Supplementary Protection Certificates (‘SPC’) for medicinal products to introduce a manufacturing waiver which, if implemented, will allow manufacturers of generics and biosimilars to manufacture certain pharmaceuticals for export outside the EU during the SPC term. See link to the proposal here. An SPC is an intellectual property right, available in EU Member States, that extends the protection of a patented medicine by up to five years. SPCs effectively compensate patent holders for time lost in undergoing lengthy testing and clinical trials prior to obtaining regulatory approval.
The proposal states the following:
“If the current legal barrier in Europe is maintained, companies wanting to produce generics or biosimilars might start to manufacture outside the Union. The EU’s ‘pioneering’ competitive advantage in the biosimilar sector might thus be lost and huge business opportunities foregone, in particular as international trading partners are quickly catching up.”
The proposal will need to be approved by the European Parliament and the Council of before it becomes law. Once adopted, the Regulation will be directly applicable in all EU Member States.