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Parliamentary questions
5 July 2017
Answer given by Ms Bieńkowska on behalf of the Commission

The Commission Communication of October 2015 on the Single Market Strategy(1) announced a package of possible measures in relation to Supplementary Protection Certificates (SPCs), including a possible initiative on an SPC manufacturing waiver. The Commission believes that this package of measures would result in an important modernisation of SPC rules and facilitate further investment in research and innovation in the fields concerned.

In line with the Commission's better regulation rules, the preparatory work regarding the evaluation and the optimisation of SPC legislation has started. An inception impact assessment was published on 16 February 2017(2). A number of studies are now under development and an online public consultation will soon be launched.

The Commission is very conscious of the position of the European Parliament regarding the SPC manufacturing waiver, which is referenced in the abovementioned inception impact assessment. It has analysed several studies related to the SPC waiver and commissioned an economic study on the potential impact of a SPC manufacturing waiver in the EU, which has now been concluded.

The Commission intends to publish this study together with the launch of the online public consultation.

Against this background, the Commission is still analysing the functioning of the SPC system, and it is thus too early at this stage to prejudge whether EU legislation will be revised.


Last updated: 6 July 2017Legal notice