Senior professional support lawyer Paul England and Matthew Royle, partner in the life sciences team at international law firm Taylor Wessing discuss what the introduction of a manufacturing waiver to the supplementary protection certificate legislation means for manufacturers.
Medicines
Back in May 2018, the European Commission published its proposal to introduce a manufacturing waiver to the supplementary protection certificate (SPC) legislation. The purpose of the waiver at that time was to allow EU-based manufacturers of generics and biosimilars to manufacture a product, protected by an SPC, in the territory of a Member State for the purpose of exporting to non-EU markets where patent or SPC protection has expired or never existed. The Commission had calculated that the non-EU market access created by the waiver would attract investment and job opportunities in the manufacturing of generics and biosimilars in the EU.