European pharmacovigilance

The big news for 2012 is the forthcoming changes to the European Medicines Agency's pharmacovigilance rules, which are expected to bring about one of the biggest changes in the area's history.

They are still out for consultation and won't come into effect until July, albeit through staggered transitional arrangements. But they could have a significant impact on digital marketing projects run by European pharmaceutical firms.

Until now the rules on pharmacovigilance have been pretty clear-cut. If it is possible for the public, whether healthcare professionals or patients, to report adverse events on your digital project then companies have an obligation to monitor it actively for them.

On a practical level, that means somebody has to check the project's website, social media channels or other digital assets on a daily basis to screen for adverse events. 

But proposed changes to the rules on screening 'digital media' for potential reports of suspected adverse events could significantly increase the burden.

The EMA says digital media should include, but not be limited to, websites, web pages, blogs, vlogs (video blogs), social networks, internet forums, chat rooms and health portals.

But beyond company sponsored digital media – where it is owned, paid for or controlled by the marketing authorisation holder – as at present, the EMA wants to go further.

The February 2012 proposals also recommended that pharma companies actively monitor special internet sites or digital media such as those of patients' support or special diseases groups in order to check if they describe significant safety issues which may necessitate reporting.

The changes also include allowing any patient in any European Member States the chance to report suspected adverse drug reactions to his or her national medicines authority – a right that only currently exists in some countries.

When this is added to patients becoming increasingly aware of, and questioning about, their diseases and the greater convenience of online communication channels, particularly anonymous ones, it could increase the number of suspected adverse events that are reported.

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