Getting Efficacy into European Trials - Applied Clinical Trials

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Getting Efficacy into European Trials
Expect a raft of new or revised EU guidelines for efficacy testing of pharmaceuticals in '08.


Applied Clinical Trials


Cynics might also interpret the delays in another EU policy as evidence that it is going adrift. The Innovative Medicines Initiative (IMI) is taking on the appearance of a mythical beast—frequently referred to, but never seen. This is the partnership-in-the-making between industry and the public sector to boost pharmaceutical research and speed valuable medicines through to market. It is invoked at every pharmaceutical-related meeting in Europe as a panacea for all ills—but it still hasn't happened.

The IMI is one of six so called "Joint Technology Initiatives" introduced in the EU's new research support program, aimed at bringing together universities, hospitals, public authorities, patient organizations, clinical centers, and pharmaceutical companies to boost biomedical research and the development of new therapies. The idea is that it will create partnerships through open calls for tender, with the main focus on precompetitive pharmaceutical research—tools to make early and reliable predictions on safety and efficacy of candidate products. Priorities will be treatments for diseases like cancer or Alzheimer's, and the total budget will be o2 billion ($2.8 billion) for 2007 to 2013—half from the EU budget and half from research-based pharmaceutical companies, in the form of staff, laboratory equipment, and clinical research. The EU funding will go exclusively to smaller firms, nonprofit organizations, academia, authorities, clinical centers or patient organizations, but not to big companies.

Blessings and bottlenecks

Recently, EU ministers gave another blessing to the concept. But the European Parliament, which has to give its opinion on the exercise, is taking an uncommonly long time to get around to even a preliminary discussion of the proposal. The French MEP appointed by the Parliament to prepare its opinion, Françoise Grossetête, has still not managed to produce an initial working paper—and requests to her office for information about the drafting are stonewalled.

Things are moving faster (though no less bizarrely) in another Parliament committee that is merely offering a secondary view. Dagmar Roth-Behrendt's draft welcomes the concept of support to the development of high tech medicines, but it also insists that research into herbal and nonprescription medicines should be included too.

Meanwhile, so nervous are some pharma industry organizations becoming about the entire project that they too are clamming up, refusing to divulge not only how far they have gone toward joining the project, but also ducking questions about where they find difficulties with the proposal. "We don't like to say anything about it to outsiders," darkly muttered the spokesperson for one high tech research organization, "because every time we raise any criticism we get into trouble with the EU authorities."

Now, about that constitution...

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.


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