TITLE:

EGA: Commission sponsored study shows Supplementary Protection Certificate (SPC) Manufacturing Waiver will create Jobs, strengthen the pharmaceutical sector and reduce medicine

BRIEF:

Medicines for Europe (former EGA) informs that the Directorate-general for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) launched a public consultation on the Supplementary Protection Certificate (SPC) Manufacturing Waiver and the Bolar exemption. The application of the SPC forces generic and biosimilar manufacturers to manufacture outside of Europe for export to countries without SPCs or whose SPC expires earlier than in Europe. With the SPC manufacturing waiver European medicine manufacturers will be able to re-invest in high skill jobs in Europe. To improve access to life saving medicines for patients, the SPC manufacturing waiver complements the Bolar provision and enable European manufacturers to bring competition at the date of SPC expiry and without unnecessary delays.