When Innovation Stops Short
The European Union had all the right goals in mind when they launched the Innovative Medicines Initiative* (IMI) in 2007. In an effort to boost the floundering pharmaceutical sector, leaders decided to bring together public and private scientists across Europe to research and develop new drugs.
According to an analysis of the program in the July 13 issue of Nature, IMI received 138 “expressions of interest” from universities and research institutes when it first called for research-project proposals. The second call turned out 124 proposals. IMI’s executive office in Brussels believes these numbers are a “resounding success,” says the Nature report. But a joint letter from a group of 11 university and research organizations, including EARTO —which is the European trade association for more than 350 research and technology organizations—states otherwise, calling the first two call responses “well below potential.”
Potential participants in the program are, in fact, quite disgruntled by IMI’s funding and intellectual property (IP) policies, says Nature. For example, some participants say they’ve had to give up certain IP rights to participate (e.g., a percentage of royalties resulting from any successful projects) and are unable to recover indirect costs of their projects (e.g., infrastructure), according to the article.
The IMI’s Joint Undertaking Governing Board is now reviewing the program’s IP policy and funding rules, and is also close to issuing its third call for project proposals. The purpose of the joint letter from the academic and research community was to provide input into that review process and ideally, affect change before that third call is issued.
Specifically, the group asks for IMI to overhaul its IP policy to provide: a “reasonable definition” of research use and access rights for third parties; less extensive access rights for participants and affiliated entities; fair conditions for access; and more balanced conditions for licensing, assignment, and other disposal of assets. With regard to funding, the group asks IMI to establish rates set at levels comparable to those of the Seventh Framework Program (FP7, part of the EU’s Joint Technology Initiatives which runs until 2013) to better engage the competitive community. They argue that the starting point for determining fees should include coverage of the full costs of the participating company’s research. Currently, there is a 20% cap on reimbursement for indirect research costs. Other FP7 programs , according to the Nature report, often offer at least 60% reimbursement.
If these changes are made, it’s likely that more organizations and universities will participate in IMI. The initiative does have quite a few interesting projects in the pipeline, including work in novel methods for developing mental-disorder medications and biomarker qualification. And we all know that when it comes to progress, the more minds, the more success.
One interesting part of this story is that research organizations say they have been complaining about IMI’s policies since the program’s inception. Now that more attention is being drawn to the issue, perhaps IMI will more seriously revisit its policies. After all, there’s no point in trying to be innovative and exclusionary at the same time.
*Note: IMI is a public-private partnership between the pharmaceutical industry represented by the European Federation of Pharmaceutical Industries and Associations and the European Union (EFPIA), aimed at supporting more efficient discovery and development of better medicines for patients by removing research bottlenecks in the current drug-development process. The initiative has a budget of 2 billion Euros and is to run between 2008 and 2017.
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