Changes to patient information in Europe
pharmafile | February 23, 2012 | News story | Medical Communications, Sales and Marketing |Â Â Commission, EC, ED, parliamentÂ
European authorities have made new proposals to allow pharma to communicate with patients and the public – but a ban on ‘direct to consumer’ advertising would remain firmly in place.
The European Commission has been seeking to update EU laws since 2008, but fears about direct-to-consumer advertising among a number of groups has held back progress on the legislation.
Three new amendments have been added the plans, and are mostly aimed at reassuring fears that pharma will have too great an influence. The amendments deal with the payment to doctors when presenting on drugs, information used on pharma websites and the industry’s involvement in printed media.
Creating this Directive has proven a difficult issue on the continent, as European authorities worry that allowing pharma to talk to patients could be a slippery slope towards direct-to-consumer advertising.
This type of direct advertising is permitted in the US, but European bodies do not want to follow suit.
Trying to create a balance between allowing pharma to give factual information on one hand, but have this not become an advertisement for a product on the other, is one of the reasons this policy has taken over a decade to form.
New amendments
The first amendment ensures that healthcare professionals, who present information about drugs on behalf of pharma companies, should declare what they have been paid and by whom.
This is a growing trend among governments and the US is leading this new transparency drive as it enshrines this obligation in next year’s Sunshine Act.
The second amendment removes the possibility of pharma making unsolicited information about prescription drugs available in printed media.
This will include health-related publications and newspapers – this will only apply to prescription drugs, and not to medical devices.
But pharma will be allowed to provide information about its medicines in print if a member of the public requests it.
The third deals with pharma websites and says firms can update information on their sites without needing to re-register it with authorities, as was previously tabled.
It also allows for the use of video content on sites, specifically relating to proper application of medical products.
The third amendment also says that pharma can link out to clinical trial databases, but would rather see this linked to the new EU medicines web portal, which is set to become accessible to the public later this year.
These latest proposals will now be discussed by the European Parliament.
Ben Adams
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