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Parliamentary questions
16 March 2018
E-000157/2018
Answer given by Ms Bieńkowska on behalf of the Commission

The Single Market Strategy announced a targeted revision of the EU Supplementary Protection Certificates (SPC) framework, an update of the ‘Bolar exemption’ and a possible unitary SPC title. Further to the publication of an Inception Impact Assessment in February 2017, a broad public consultation took place between 12 October 2017 and 4 January 2018 covering Supplementary Protection Certificates (SPCs) and patent research exemptions for sectors whose products are subject to regulated market authorisations. A total of 231 contributions were submitted by a very diverse range of public and private stakeholders. The Commission is currently analysing these responses.

In parallel, the Commission has contracted several studies on these SPC related matters, with the final results of the remaining studies expected shortly.

Regarding an eventual legislative initiative for an SPC manufacturing waiver, the Commission will carefully consider all options and their impacts on stakeholders, before taking any decision about a possible proposal.

Last updated: 16 March 2018Legal notice