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Parliamentary questions
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28 June 2018
Answer given by Ms Bieńkowska on behalf of the Commission
Question reference: E-000512/2018

Further to the announcement in the 2015 Single Market Strategy, a legislative proposal to fine-tune the EU supplementary protection certificates (SPC) system was adopted by the Commission on 28 May 2018(1). This initiative, called for by European Parliament in its Resolution on the Single Market Strategy in May 2016, proposes a targeted adjustment to the existing SPC Regulation, through the introduction of a manufacturing waiver for export purposes. This proposal follows an inception impact assessment in February 2017, a public consultation in autumn 2017(2), and a series of independent studies related to SPCs(3).

A wider review is underway in the context of the analysis of pharmaceutical incentives called for by the Council in 2016, which the Commission is currently undertaking. This is based on various sources of evidence, including a recent study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe, conducted by Copenhagen Economics, published on 28 May 2018(4), and the ongoing evaluation of the EU paediatric and orphan legislations. The Commission will engage in further discussions with all stakeholders about the outcome of this analysis.

(1)COM(2018) 317.

Last updated: 28 June 2018Legal notice