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Universities shun Europe's drug initiative

Intellectual-property rules push researchers away.

Europe's pharmaceutical industry, struggling with huge research costs and unfriendly regulation, has been limping along for more than a decade. To help the ailing sector, the European Union (EU) in 2007 launched the multibillion-euro Innovative Medicines Initiative (IMI) to bring public and private researchers together and speed up drug development.

But the partnership is now looking less than healthy. Many universities and public research institutes are complaining that the high cost of participation, and a raw deal on intellectual property (IP) rights, is stopping them from taking part.

In its first call for proposals, the IMI received 138 'expressions of interest' from universities and research institutes across 18 research topics. In the second call, it garnered 124 expressions of interest over 9 research topics — a resounding success, says the IMI's executive office in Brussels.

One of the key objectives of IMI is to deliver innovative medicines to patients in a faster way. ,

Yet as the IMI prepares to launch its third call this autumn, a group of 11 leading university and research organizations has published a joint statement saying that the call is unlikely to succeed unless the funding and IP rules are changed. The 6 July statement says that, owing to these concerns, participation in the first two rounds has been well below potential.

The research organizations say that they have repeatedly expressed their concerns to the European Commission (EC) and to the IMI's managing bodies over the past two years, but have seen no progress. Pauline Bastidon, a policy officer at the European Association of Research and Technology Organisations, a trade association which co-signed the statement, says that some universities have been forced to give away potentially valuable IP rights in order to take part in projects.

The IMI is one of five ambitious applied-research programmes known as Joint Technology Initiatives (JTIs) — the flagships of the EU's €50-billion (US$63-billion) Seventh Framework Programme (FP7), which runs until 2013. The EC conceived the JTIs to help promote research collaborations between academia and industry and to translate basic science into potentially lucrative technologies. Each JTI draws up its own rules on funding and IP. In the case of the IMI, the research agenda is largely determined by industry.

"One of the key objectives of IMI is to deliver innovative medicines to patients in a faster way, by speeding up discovery and development in the pharmaceutical sector," says Michel Goldman, executive director of the IMI. Its IP policy "was designed to promote swift disclosure and exploitation of new knowledge", he says.

But universities say that they are loath to join an IMI project which generates IP that they cannot own. Unless the IMI revises its IP strategy, it is unlikely that new drugs will be developed from these projects, says Thierry Troosters, a researcher at the Catholic University of Leuven in Belgium. Troosters is taking part in an IMI project to gather information from patients with pulmonary disease to ascertain what physical activity aids their recovery. He says that he designed his study proposal to omit any technologies or concepts that the university itself hopes to exploit.

Universities also complain that the programme allows them to claim back only 20% of the indirect costs of a project, including infrastructure and computing support. By contrast, other FP7 projects reimburse universities with at least 60% of their indirect costs.

Linda Polik, European adviser at the research services unit of the University of Oxford, UK, says that although the university expressed interest in five projects in the first IMI funding round, it did not participate in the second call because it could not afford to cover the indirect costs. She says that the university will only participate in the third round if interested departments can make up the funding shortfall from elsewhere and state a case for doing so, given the unfavourable IP rules.

"We are aware that some organizations have concerns," says Goldman. But, he notes, "155 academic and other research organizations are already participating in ongoing IMI projects under the current IP policy, and the general feedback we get from project participants is positive".

Goldman adds that the IMI has already published guidance to help applicants in the IP negotiation process, and is due to update that information before the next funding call. And the EC, which has representatives on the IMI's governing board, is assessing the impact of the 20% costs cap.

Yet for those institutions that have participated in the IMI, it has been a bruising experience that they say is deterring others from joining. Ulf Johann, legal adviser to the Fraunhofer Society, a research organization in Munich, Germany, says that last-minute changes to a legal agreement governing the society's participation in an IMI project to develop biomarkers forced it to give up all rights to any research royalties. Johann says that the society had been threatened with exclusion from the project if it did not sign.

"People might remember [the IMI] more for the problems over IP than for providing new medicines," he says.

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Gilbert, N. Universities shun Europe's drug initiative. Nature 466, 306–307 (2010). https://doi.org/10.1038/466306b

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