Europe: Countdown Time for the Innovative Medicines Initiative?

Momentum is gathering in Brussels for real battles over carving up the 1 trillion dollars that the European Union has now agreed to spend between the end of this year and the end of the decade. The constituencies jostling for funding include farmers and foreign aid workers, teachers and train operators, and legislators and local authorities. Among some of the most vociferous candidates for funding, unsurprisingly, is the scientific community - with good prospects, since research is very much flavor of the moment as the EU struggles to inject new vigour into its sluggish economy.

Against that background, one of the leading pharmaceutical projects that benefits from EU funding under the current arrangements is putting everything it can into proving its worth, with a view to getting a slice of the money that will be around in the next funding period too. The Innovative Medicines Initiative is already receiving more than 1 billion dollars from the EU - with a matching 1 billion dollars in kind from drug firms in Europe. The focus of this public-private partnership is support for more efficient drug discovery and development, through collaborative research and new networks of industrial and academic experts.

IMI’s 40 projects now underway range widely across safety and efficacy, knowledge management and education and training. Just a week ago, its most recent announcement related to revitalizing antibiotic development. Its “New Drugs 4 Bad Bugs” program to combat antibiotic resistance in Europe is investing 200 million dollars in a new clinical research agenda, alongside more than 30 million dollars in studying new pathways for getting antibiotics into bacteria. A key outcome will be a pan-European clinical trial network capable of recruiting patients and of conducting efficiently high quality multinational trials at all stages of development. Alongside this, the project will also establish a pan-European laboratory network to deliver epidemiological information and data from microbial surveillance work to guide the selection of clinical trial sites.

The choice is smart, in that antimicrobial resistance is a growing problem worldwide, and with few new drugs making it to the market, there is an urgent need for new medicines to treat resistant infections. It is even smarter, given that the EU has adopted a strategy on combating antimicrobial resistance into which the IMI projects neatly fit.

But IMI’s vision is now nearly ten years old, and its leaders are conscious of the need to demonstrate its relevance for a changing future, too. This is doubtless one of the reasons IMI has thrown its weight behind current initiatives in the EU to explore the potential of personalized medicine. This is another area that the EU has identified as important – but has yet to get to grips with in any effective manner. A policy paper promised for last year on the implications of new science for personalized medicine has yet to appear, and a wide range of organizations are vying to take a lead in EU debates on the subject. Given the need for a multidisciplinary approach to developing personalized medicine, IMI is being smart here, too, because it is one of the few games in town that has so far demonstrated success in bringing together a broad coalition of industry, academia, hospitals, patients and regulators.  Now, as the real fighting gets underway over who gets what out of the EU’s budget over the next seven years, IMI is going to have to do some even more powerful demonstration of its merits if it is to come out a winner.