Conflict 6 IMI Rules Come With Hitches

IMI is hoping to bring together representatives of industry, small- and medium-sized businesses and academics -- but in doing so, it is alienating many universities in Europe. Mid-sized research institutes are also having a tough time.

DPA

Many scientists were initially pleased with the idea of the research initiative, especially about the possibility of working with pharmaceutical-industry colleagues on exciting and important projects. But it didn't take long for academics' disappointment to set in. Once the project started, many workers at the 155 initially participating universities had to learn the hard way that different rules applied to the Innovative Medicines Initiative (IMI).


IMI's Scientific Research Partners

The graphic shows where the close to 560 IMI partners at universities and research institutions are located. There are also an additional 19 partners participating in IMI projects that cannot be ascribed to a single country. Some partners are involved in multiple IMI projects.

In October 2010, two major European university associations pulled the emergency brake. Both the League of European Research Universities (LERU) and the European University Association (EUABE) -- who represent the interests of many of the European universities participating in the project -- have expressed harsh criticism of the EU research project. Many universities left during their initial IMI projects or said they would not consider participating in another.

"Progress can only be made when both partners can conduct research on equal footing and when they are contributing at the same level," says Angela Noble, a researcher at the University of Edinburgh and spokesperson for LERU.

The Criticism of Universities and Smaller Research Partners:

Money Is Calculated Too Tightly for Universities

The first obstacle for many scientists was the fact that the amount of subsidies initially made available for IMI projects were far too low. In all other EU research programs in which university professors work on joint projects with partners in industry, the subsidies are sufficient to cover the money required for their teaching activities as well as pay for their employees, says Angela Noble, a researcher at the University of Edinburgh and spokeswoman for the League of European Research Universities (LERU).

Universities often had to supplement the IMI subsidies with their own funding, something many of the institutions could afford at best one time.

Researchers complain that they are still forced to resort to tricks in order to get the funding they need. In some cases, professors include their own salaries despite the fact that they are already paid by their universities. The additional funds from the EU are then used to pay workers, explained one researcher who asked that his name not be published.

During the second phase of IMI, funding was adjusted slightly.

Few Rules Pertaining to Intellectual Property

Researchers at the University of Freiburg in Germany are also familiar with the problems with IMI. Researchers at the college are participating in the MIP-DILI project, which is developing tests that can be used in an early stage of pharmaceuticals research to determine if a medication is harmful to the liver or not.

Even today, the issue of how the findings of an IMI project will be handled has been insufficiently addressed, says Christian Jäger of the university's office for EU relations. In other research projects, he says, there are clear rules regarding the use of "intellectual property" -- what an institution discovers in the course of a joint research project has always then become its own intellectual property.

"If someone wants to use what the other partner has discovered, they have to request permission from the project partner," he says. That's not the case at IMI though. New rules were created for the research program, and nobody knows why. Initially, the findings from IMI projects were almost automatically made available to the participating pharmaceutical companies. Further use of the results was also largely unrestricted for the companies, who were more or less free to pass the findings of other project partners on to third parties.

Following criticism from universities, IMI participants improved the rules, but there is still considerable room for improvement. Jäger says there is now an embargo that pharmaceutical companies must honor before they can share research findings with third parties. But under current provisions, the specifics of those rules must be determined between the partners. And given how large the legal departments are at many pharmaceuticals firms, it is clear how these negotiations are likely to end. The knowledge of that alone is enough to scare many university researchers. "IMI is set up in a way that a public-private partnership should not be," says Jäger.

Pharmaceutical Companies Rewrite Proposals

Another problem is the fact that the pharmaceutical industry is overly powerful within IMI in terms of pushing through its own research agenda. In the creation of programs, the pharmaceuticals industry "has a very dominant position," says a researcher with a small research institute that has been working with IMI from the beginning. Like many of her colleagues, she says she doesn't want to go on the record with her name in order to prevent jeopardizing on-going project work. She says that many of the proposals made by small- to medium-sized businesses and universities are rewritten to an extreme degree. She says firms that are part of the European Federation of Pharmaceutical Industries and Associations often use their veto power within IMI if they are currently researching an interesting disease pattern on their own. This often means that smaller organizations are relegated to conducting research on lesser issues. "That inhibits creating more dynamic projects," the researcher says.

During the course of their reporting, the journalists working on this series viewed internal papers on the progression of several IMI research projects. They found it is true that the academic partners often propose a completely different list of indicators to be researched than those that are ultimately reviewed. Industry often votes against them -- presumably because they are already conducting their own research in those areas.

The European League of Research Universities (LERU) has also criticized the fact that IMI rules are biased towards pharmaceutical companies. "Academic partners, still aren't treated as equal partners within IMI," says Kurt Deketelaere, a law professor at the University of Leuven in Belgium and general secretary of LERU.

IP Rules Are Driving Universities and Small Organizations out of IMI

Small- and medium-sized companies also felt they didn't get much out of the first phase of IMI. For many, the complicated application process alone was more than they could handle. The German biotechnology industry association BIO Gemany, for example, said small- and medium-sized businesses didn't have the time to review the complex IMI contracts. Viola Bronsema of BIO Germany also says that IMI's intellectual property rules are biased towards the large pharmaceutical companies. BIO Germany aired its complaints in a letter to Elmar Nimmesgern, a colleague of IMI chief Irene Norstedt, sent in 2012. The letter sharply criticized the intellectual property rules. "We still haven't been given a convincing explanation for the deviation," it stated.

It is difficult for project partners at the universities to express their criticism. They fear that airing their opinions might threaten on-going projects in which their universities have already invested a lot of money.

From the very beginning, the European Parliament has sought again and again to improve IMI conditions to make them better for universities. But it is difficult, says Iris Matschilles, a policy advisor on energy, research and industry in the EU Parliament. She said members of the European Commission were simply happy that IMI is responsible for coordination and that they don't have to micromanage the program.

  • especially at the beginning, the funds provided to participating universities were too small. Many universities were forced to provide additional financing.

  • during the second phase of IMI, slight adjustments were made to the distribution of funds. But researchers still have to resort to tricks in order to obtain sufficient funding.
  • the question of how the results of an IMI project will be dealt with has yet to be truly resolved.
  • the pharmaceutical industry still has an overly dominant position in setting the research agenda.

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