The industry dared to be optimistic, but was disappointed. Drug chiefs were hoping for more opportunities to communicate directly with patients in Europe, as part of much-needed change to marketing and selling models. (Read more on that in the forthcoming issue of IN VIVO).
The proposals allow information which "does not go beyond the elements of the summary of product characteristics," plus "related information about non-interventional scientific studies," according to EC documents published today. And this information can be disseminated only via specialist publications and websites--no active distribution allowed. "It's a pull-model," summarized Barker--in other words, just about as far from DTC as it could possibly be.
Not that DTC was what the industry was after; it knows that doesn't work particularly well anyway (and some CEOs apparently hate it with a vengeance). But a little more freedom to communicate might have been nice. So would more clarity on whether information must be vetted pre- or post-dissemination: a summary memo released prior to the full documents states that "in general information will be subject to monitoring after it has been disseminated."
The full text, though--and what was picked up in this Reuters piece--says that "monitoring should be based on the control of information prior to its dissemination, unless the substance of the information has already been agreed by the competent authorities or if there is a different mechanism in place to ensure an equivalent level of adequate and effective monitoring." [our ital.]
Hmm. Assuming that last bit means that pre-vetting can be avoided (communication may prove highly burdensome if not) the proposals at least "don't take us backwards," adds Barker. In the UK, limited information is already available to patients via sites like medicines.org.uk. Like anything coming out of the EC, the package is a compromise between opposing positions. UK and Scandinavian attitudes to patient information contrast with that of France, for example, which remains highly sensitive to any sort of direct channel between manufacturer and patient.
Patient information is just one part of this story. Pharmacovigilance and counterfeit drugs feature too--though the branded sector missed out on a complete ban on the re-packaging of pharmaceuticals, which would have crippled parallel traders. (They rely on this to re-sell drugs bought in low-priced country A to higher-priced country B.) The finalized plan, unlike earlier drafts, states explicitly that "re-packaging remains possible"--a big nod in the direction of the parallel traders' lobby.
This set of legislation is tabled as a "renewed vision" for the European drug sector. But for Barker, it represents only a very small step, albeit in the right direction. "We need to go well beyond these measures to give a real boost to an industry's that's packing up and leaving Europe," he warns.
It's not enough to "launch reflections," as the EC is doing, on ways to improve market access and boost R&D. Aggressive action is needed if Europe isn't going to slide further behind, in particular given the rise of investment in developing markets. But aggressive action isn't what the EC does--or can--provide.