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Parliamentary questions
10 April 2017
E-002602-17
Question for written answer
to the Commission
Rule 130
Mairead McGuinness (PPE)

 Subject:  Supplementary Protection Certificate (SPC)
 Answer(s) 

It is argued that an SPC manufacturing waiver allowing industries to produce generic and biosimilar medicines in Europe for the purpose of exporting them to countries without SPC or where it has expired earlier, would have a huge impact in terms of new investments in R&D and manufacturing, employment and economic growth within the EU.

Is the Commission aware of studies showing that the export of generic and biosimilar medicines to unprotected markets during the SPC period would stimulate investments in Europe and help increase access to high quality medicines?

Can the Commission provide evidence that either supports or does not support the purported significant positive impact generated by the introduction of an SPC manufacturing waiver?

Parliament has pushed for such a waiver on a number of occasions. In light of the new economic and social data emerging on the issue, is the Commission reconsidering its stance on the introduction of an SPC manufacturing waiver for export and does it plan to take action on this issue?

Last updated: 3 May 2017Legal notice