Impact of the draft EC data protection regulation on the life sciences sector

The draft EC data protection regulation proposes a number of changes to the EU data protection regime, which, if adopted, will have significant implications for data controllers and data processors in the life sciences sector.

Collection and analysis of personal health data is fundamental to the extensive research that takes place in the industry in order to develop and supply safe and effective medical products, which are vital to society as a whole. However, such data is often highly sensitive and the commission’s desire to increase protection for data subjects may significantly increase the compliance burden on those processing personal data in this field.

Compliance with data protection laws already represents a considerable challenge for pharmaceutical companies, clinical research organisations, laboratories, sponsors, statisticians and a host of other data controllers and processors involved in clinical trials. Since such projects commonly involve parties based all over the world, they require significant international transfers of sensitive personal data. Furthermore, it is not always clear whether such organisations will be considered controllers or processors, meaning that navigating, for example, the restrictions on cross-border transfers and implementing appropriate solutions can prove a very complex exercise…

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