Position Paper

EBE View on the SPC Manufacturing Waiver

02 Aug 2018

The European Biopharmaceutical Enterprises (EBE) has just released its latest position paper, raising concerns on how the SPC manufacturing waiver will affect innovative biopharmaceutical companies, particularly SMEs.

EBE believes that allowing generic and biosimilar drug makers to manufacture for export before the SPC expires would disadvantage innovative SMEs. While the waiver will only have a very limited positive impact for the biosimilar and generic industry, it will be detrimental to the biopharmaceutical innovation in the EU on the long term. EBE requests that policy makers to consider its concern and stands ready to engage in a constructive dialogue on the issue.

To see the full position, click here.

See also the EBE statement on the European Commissions proposal to introduce an SPC manufacturing waiver, which puts patient care at risk.

2018-09-12T07:53:46+00:00August 2, 2018|