The European Commission has amended its 2001/83/EC Directive regarding
information to the general public on prescription medicines, and looks to
tighten up proposed relations between patients and the industry.
The three main 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 amendment 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 amendments come after changes were made to the Directive last October. These latest proposals will now be discussed by the European Parliament.