EU

EDPB opinion on GDPR and Clinical Trials Regulation clarifies the basis for processing personal data in a clinical trial context

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

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

Belgian consumer association announces potential complaint for abuse of dominance based on excessive pricing allegations

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

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

New formulations of existing active substances are not entitled to an SPC according to Advocate-General

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