EU
15 February 2019 - Posted by: Emma Keeling
On 23 January 2019, the European Data Protection Board (the EDPB) adopted an opinion on the interplay between the EU Clinical Trials Regulation (536/2014) (the CTR) and the General Data Protection Regulation (2016/679) (the GDPR) (the Opinion). The Opinion aims to provide greater certainty for those conducting clinical trials, clarifying: the distinction between consent requirements › Read More
European Commission issues report on antitrust enforcement in the pharmaceutical sector
30 January 2019 - Posted by: Dominc Long
A decade on from its inquiry into the pharmaceutical sector in 2009, on 28 January 2019 the European Commission (EC) issued a report providing an overview of antitrust law enforcement (antitrust and mergers) in the EU from 2009-2017 in the pharmaceutical sector. The report confirms that effective enforcement of EU antitrust rules in the sector › Read More
29 January 2019 - Posted by: Francesca Miotto
Last week, a spokesperson for the Belgian consumer association Test Aankoop/Test Achats announced that the association is likely to lodge a complaint with the Belgian Competition Authority against the Italian pharmaceutical company Leadiant. Allegedly, Leadiant abused its dominant position in the market for chenodeoxycholic acid (CDCA), the active substance in the treatment of the rare › Read More
MHRA provides further guidance on no-deal Brexit plans
14 January 2019 - Posted by: Jacqueline Bore
The MHRA has issued updated guidance on its plans for the regulation of medicines, medical devices and clinical trials in the event that the United Kingdom leaves the European Union on 29 March 2019 without any agreement on its future relationship with the EU and, therefore, without any transitional period. The guidance reflects responses to › Read More
09 January 2019 - Posted by: Toby Sears
The Opinion of Advocate General Saugmandsgaard Øe in Abraxis Bioscience (Case C-443/17) was delivered on 13 December 2018. The Advocate General concluded that the UK Intellectual Property Office had been correct in declining to grant a Supplementary Protection Certificate (SPC) to Abraxis for a novel formulation of an active substance which had already been the › Read More