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Euro'vision blog

A look at the key issues for pharma across Europe

Following Yonder Star…

The legends tell us that this is the time of year when Wise Men look for meanings in the heavens, and long foretold prophesies come to life. So it’s a fitting season to once again look at the long foretold but so far elusive 'Information for Patients' legislation at the European Commission and Parliament…

What? I hear you ask…. Surely that is dead and buried – lost in the red tape and endless rounds of bureaucracy that make up our European legislation. Actually no; like Oscar Wilde's famous note: “News of its death are sorely exaggerated'. So exactly what has happened?

First it's important to understand why this legislation is important. Under current EU law, it is illegal to communicate any information at all to the general public about prescription medicines. The only communication must come via a medical practitioner or in the Product Information Leaflet (PIL) that the patient who has actually been prescribed the medicine receives. 

Obviously with the internet age, and the freely available information available on prescription medicines from America, not to mention the widely available misinformation, the public is going to be able to find out things about medicines whether the legislators like it or not. The lack of quality and the un-verified nature of this information is what keeps the Commission awake at night.

The European Commission's aim is to improve the quality of information available to patients on prescription products in order to have well-informed patients, who are better able to access effective medication. Which is a very worthy objective. And that is why the Commission has re-worded the Information to Patients' legislation and why there is a pretty good chance that sometime not too far away, it might actually get to the EU Parliament for a vote.

And what is actually being proposed? In a nutshell, the Commission proposes that the public should have access to the information and facts that are contained in the PIL but also to the studies and results that were used to register the product. Roughly translated this is probably the information already published on the EMEA website in the product's EPAR. 

Fairly straightforward you might think, but one less clear aspect is how the public will be able to access this information. The Commission's recommendation is that the information is distributed by 'approved' websites, but quite what 'approved' means remains unclear. A likely scenario is that the Commission will follow the Swedish model, where each Member State will have a centralised portal for all information, controlled by that State. A more unlikely scenario is that the Commission will approve a number of sites that meet a set of criteria. 

And what is crystal clear is that there will be no softening of the Commission's attitude toward promotion of prescription medicines directly to the public.

So perhaps a bit of Festive cheer, blended as always, in matters pertaining to the European Parliament, with equal measures of opacity. And on second thoughts, perhaps using the 'Three Wise Men' analogy to introduce matters of EU Legislation wasn't the wisest of choices!! Merry Christmas!!

Article by
Max Jackson

Max Jackson is CEO, EMEA & APAC, Sudler & Hennessey and former chair EACA Healthcare Communications Council

14th December 2011

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