Guest blog by Reflector, Pharm Exec Europe’s Brussels correspondent.
American drug firms have been pushing for it for years, and so — in an entirely different direction — has the European Parliament. Patient groups are divided over whether it’s needed. The European Commission (EC) says it’s definitely time for action. But EU member states — and many European drug firms — are happy to see it crumble to dust.
“It” is draft legislation on information to the public about prescription drugs. Everyone recognizes that the internet has changed the entire drug information game — feeding the appetites of growing numbers of people who want to be more involved in their own healthcare. So, over a year ago the EC proposed to update Europe’s creaking rulebook, which currently forbids drug firms initiating any communication with the public on prescription products.
The Commission said the EU should plug the loophole that currently allows everyone — except the maker of a medicine — to say more or less what they like to whom they like about any medicine they choose to comment on. Freedom of speech considerations, and the anarchic nature of the internet, make it impossible to stop the unauthorized (and often misleading) information that litters the web. But logically it should be counterbalanced by making available some authorized information, the Commission argues — and drugmakers are one of the obvious sources of such information.
Some patient groups agree — subject to strict monitoring and control of the information that the public can have access to. But others object, fearing mission creep that will turn a trickle of objective information into a flood of promotion. Many member states take the same view, arguing that prescription medicines are not just ordinary goods, and a health professional should always be there to filter information to the public.
Medicine makers with operations in the US are used to far more ambitious direct-to-consumer advertising, and they consider Europe to be irritatingly coy with all these hesitations about something much more neutral. But firms with a more European tradition are cautious for good reason: they know that if any drug firm that is given an inch of information under a new and laxer regime takes instead a yard of advertising, the entire industry will suffer from the predictable backlash of even tighter controls.
The European Parliament is now stepping into the picture. German liberal MEP Jorgo Chatzimarkakis is first into the fray with an opinion he has drafted on the draft legislation. He strongly supports the idea of more public access to information. “It is a fundamental principle in a democratic society that citizens have a right to access information, including on prescription medicines,” he says. This is in line with the parliament’s longstanding call for greater access to drug information. But Chatzimarkakis is pragmatic rather than dogmatic.
“The information currently available in the EU about prescription-only medicines is neither adequate nor timely,” he says, because access to information depends on how proficiently the citizen can use the internet and which language he or she speaks. He explicitly recognizes that marketing authorization holders “also constitute a valuable source of non-promotional information” about medicines.
Naturally he also calls for adequate safeguards. He says high-quality information will require “coherent application of clearly defined standards across the European Union”, along with effective national control measures.
But he evinces none of the tribal prejudice against the drug industry that has often characterized the discourse of his parliamentary colleagues, and which has already led to some extravagant expressions of concern over the trustworthiness of the medicines industry.
Three parliamentary committees are to examine the issue — and they are not necessarily going to take the same balanced view as Chatzimarkakis. So there is still the risk that the legislative initiative could backfire, and result in tougher controls than apply at present. Particularly since there is little prospect of support from member states. They have refused even to discuss the proposal for over a year, and Spain, which holds the EU presidency until mid-2010, has made clear that it opposes the measure and wants no discussion of any relaxation of controls.
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