From: Data Guidance
The EU Clinical Trials Regulation (No 536/2014) (‘the Regulation’) will enter into force – on 16 June 2014 – 20 days following its publication in the Official Journal of the European Union (on 27 May 2014). The Regulation repeals the Clinical Trials Directive (2001/20/EC) (‘the Clinical Trials Directive’) and Directive 2005/28/EC. The Regulation was adopted by the Council of the European Union (‘the Council’) on 14 April 2014.
“Unlike the previous [Clinical Trials Directive], [the Regulation] really is immersed in data protection language,” Daniel Cooper, Partner, Covington & Burling LLP and a DataGuidance Pharma Panel Expert, told DataGuidance. “There are many more points now where this Regulation will intersect expressly with data protection principles […] for instance, there is a section in the Regulation that actually calls for submission of information as part of the application relating to addressing security breaches […] [and] a specific provision dealing with data security, Article 56, it essentially contains language that mirrors the language in the current Data Protection Directive with respect to data security calling for appropriate technical and organisational measures.”
The Regulation aims to make the EU ‘more attractive for clinical research,’ as the Council stated, and also to “increase transparency in clinical trial activities,” evident in the segment of the Regulation dedicated to the EU clinical trials database.
There are many more points now where this Regulation will intersect expressly with data protection principles.
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