SPC manufacturing waivers: A blow to innovation?

The European Federation of Pharmaceutical Industries and Associations (EFPIA) criticised the manufacturing for export exemption for EU Regulation 469/2009 initially proposed by the EC and amended by the Committee of the Permanent Representatives of the Governments of the Member States to the European Union (COREPER) in mid-January. It’s critical to note that implementation of the regulation will be at the cost of high-value research and development jobs in Europe, stated the EFPIA.
Under the current EU right, European biosimilar and generics makers are barred from producing their products within the SPC period that was introduced to offset the…