To ensure safer and more effective drug development it is vital
for the life sciences industry to be able to collect, analyse and
transfer personal data, including sensitive personal data for
clinical trials, pharmacovigilance and medical research. The EU
General Data Protection Regulation (the Regulation) was formally
issued by the European Commission in January 2012 to replace the
existing EU data protection framework (Directive 95/46/EC).
The Regulation could adversely affect the life sciences industry
and is perhaps the most important piece of proposed European
legislation in many decades for the industry. One of the key
potential advantages of the Regulation for the life sciences sector
is the promise that data protection laws may (at last) be
harmonised across all 28 Member States. The Regulation is slowly
progressing through the European legislative process and is likely
to be adopted in 2016. Once adopted it is intended to be
enforceable in all Member States
