Launched on 28 October 2015 , the European Commission’s new strategy ‘A Single Market Strategy for Europe – Analysis and Evidence’ proposes a manufacturing waiver during the SPC period to allow the EU generic and biosimilar medicines industries to create up to 64.000 high-tech jobs in the EU and dozens of new companies, with a €3.3 billion business value.
The measure would also bring pharmaceutical R&D back to Europe as R&D and manufacturing are often conducted on the same sites for pharmaceuticals. The export of generic and biosimilar medicines to non-EU countries during the SPC period will increase access to high quality medicines in third countries without changing the equilibrium between the originator and the generic & biosimilar medicines industries in the EU.Today the Committee on Internal Market and Consumer Protection (IMCO) of the European Parliament adopted its report on the “Single Market Strategy” calling on the Commission to stimulate manufacturing and early export of generic and biosimilar medicines to countries where no patent or supplementary protection certificates (SPC) exist.
Adrian van den Hoven, Medicines for Europe Director General commented: “The Parliament has once again voted for more manufacturing jobs for Europe by calling for an SPC manufacturing waiver. The Commission should now move forward without delay to make a formal legal proposal to deliver on this tremendous development opportunity for the European pharmaceutical manufacturing industry”.