Introduction of an export exception (waiver) within the existing Supplementary Protection Certificate Regulation

19.10.2015

Question for written answer P-013919-15
to the Commission
Rule 130
Antonio López-Istúriz White (PPE) , Antonio Tajani (PPE) , Alessia Maria Mosca (S&D) , Jerzy Buzek (PPE) , Philippe De Backer (ALDE) , Antanas Guoga (ALDE)

At a time when the EU is seeking further economic growth and job creation, it is crucial to stimulate the competitiveness of EU industry and to strengthen its leadership globally, creating new market opportunities.

A specific action in the generic and biosimilar medicines field could achieve this purpose, further stimulating production for export to third countries: the introduction of an export exception within the existing Supplementary Protection Certificate (SPC) Regulation.

This would help to eliminate barriers to the competitiveness of the EU industry by allowing it to manufacture for export both generics and biosimilars which are still protected by an SPC in the EU but not in the country of destination.

In addition, this would be in line with the Commission’s approach to better regulation and would not change the EU’s internal protection equilibrium between originator products and generic or biosimilar medicines.

Parliament has already supported this concept in its resolution of 9 June 2015 on the enforcement of intellectual property rights in third countries, calling on the Commission to stimulate early export of these products.

In light of the above, is the Commission considering such targeted action in the context of the upcoming internal market strategy?