EU

New German Appointment Service and Supply Act: Implications for investors in the dental industry

Eda Zhuleku

On 14 March 2019, the German Parliament (Bundestag) adopted the German Appointment Service and Supply Act (Terminservice- und Versorgungsgesetz; TSVG), which will come into force in May 2019, as the German Federal Council (Bundesrat) did not veto the law. During the legislative process, it was feared that the Act would have significant impact on the Read More

More’s the Pity – Rules on Distinctiveness

David Stone

A recent General Court decision emphasises the difficulty of registering slogans as trade marks, including for specialised medical devices. Medrobotics Corp had applied for registration of SEE MORE. REACH MORE. TREAT MORE. as an EU trade mark (Medrobotics v EUIPO T-555/18) in relation to articulated arms and probes for medical diagnostic and surgical use. Medrobotics’ Read More

ECJ: notification of carve-out for the patented indications in SmPC and PIL by a generic producer limits the scope of the MA

Anna-Maria Withagen

On 14 February 2019, the European Court of Justice (ECJ) published its preliminary ruling related to the policy of the Dutch Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen – CBG) concerning the limitation of a market authorisation (MA) upon a request of a generic producer for a carve-out of the patented indications in the Read More

Coordination amongst member states on medicines’ prices supported by the European Commission

Nele De Backer

European Commissioner for Health and Food Safety, Vytenis Andriukaitis, said that the European Commission will support national competition authorities in their probes against excessive pricing practices in pharmaceutical markets. In addition, the European Commission will continue to monitor pharmaceutical markets itself, as part of its competition policy, and is ready to act against infringements of Read More

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