Pharmacovigilance at heart of EC patient information proposals

pharmafile | October 12, 2011 | News story | Medical Communications, Sales and Marketing patient information 

Pharmacovigilance is at the centre of revised proposals announced this week setting out what information pharma firms can put on prescription-only medicines.

The European Commission has amended Directive 2001/83/EC, which deals with the information patients should receive about medicinal products.

The current advertising ban – including in the general print media – will remain in place. But along with information on the label or leaflet, companies will be able to use officially registered websites or printed material that is specifically requested by members of the public.

The revisions say all information must be unbiased, evidence-based, factually correct, not misleading and understandable.

Pharma industry group EFPIA has welcomed the amendments, urging all member states to adopt a “pragmatic approach” to address what it calls “the existing inequality” of access to quality data.

“Modern society already has access to a great deal of information via the internet,” EFPIA said in a statement. “Future discussions should examine ways to ensure that high-quality information is accessible to all in their own language, to benefit Europe’s patients and public health.”

“The revised proposals put rights, interests and safety of patients first,” insisted John Dalli, European Commissioner for health and consumer policy.

“They oblige industry to provide certain key information to patients and set clear rules for additional, voluntary information on prescription medicines. In addition, they further strengthen the control of authorised medicines,” Dalli added.

The changes to the EU pharmacovigilance system to which Dalli alludes are, specifically, the creation of an automatic procedure at European level where there are serious safety issues.

This would be with a view to ensuring that safety problems are assessed and addressed in all member states where a drug is authorised.

Another revision seeks to clarify the information that marketing authorisation holders are obliged to impart: the idea here is to avoid the possibility of safety issues not being addressed in the EU following the voluntary withdrawal of a marketing authorisation or product by the holder.

The revisions amend the original Commission proposals of 2008 and will now be debated by both the European Parliament and the Council of Ministers.

Adam Hill

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