The European Parliament legal affairs committee votes in favor of a comprehensive SPC manufacturing waiver
In May 2016, the European Parliament, in its Resolution on the Single Market Strategy, endorsed the need for changes to the EU supplementary protection certificate (“SPC”) and urged the Commission to introduce and implement an SPC manufacturing waiver before 2019, without undermining the market exclusivity granted under the SPC in the protected markets.
CJEU and SPCs: a never-ending story
The work of the Court of Justice of the European Union (CJEU) on Regulation (EC) No. 469/2009 (Regulation), on supplementary protection certificates for medicinal products (SPCs), has been quite intense in the last few years, and it still is, given that in the pharmaceutical sector even one more day of exclusivity can be worth millions of euros, so fighting for it is certainly worth the investment of time and money.
Product information: EMA starts digitization
The European Medicines Agency (EMA) gives the go-ahead for digitization in terms of product information.
EUCJ’s ruling on the classification of software as medical devices
According to a very recent ruling of the European Court of Justice (EUCJ), (C-329/16, Snitem v. Syndicat national de l’industrie des technologies médicales, published on 7 December 2017), software with at least one function that makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device, even if that software does not act directly in or on the human body.