University researchers have criticised the €2 billion public-private Innovative Medicines Initiative (IMI), claiming their participation is at risk unless major changes are made to financial and intellectual property arrangements.
The League of European Research Universities (LERU) – a group representing some of the biggest names in academia – has written a stinging letter to the board of the IMI highlighting "deficiencies" in the programme, which academics claim have hurt the international credibility of the initiative.
The researchers say the academic community has not participated fully because universities risk making a loss by signing up to the venture, and the group paints a picture of chaos and distrust over intellectual property as well as how projects are managed.
But the IMI has hit back, saying academics and SMEs have been lining up to take part in the initiative, adding that its structures are designed to ensure research is commercialised as efficiently as possible.
Researchers critical of IMI structures
LERU stressed that it backs the spirit of the initiative and academic scientists are keen to collaborate with industry to boost the pharmaceutical sector. However, it says this can only be achieved if scientists are treated as equal partners "with clear benefits for both sides".
"IMI shows how a public-private partnership should not be set up. The combination of disadvantageous financial and intellectual property rules represent a double negative when it comes to academic or SME participation," says the letter.
The absence of mutual benefits has led to "marked disinterest" from academics in the first two calls for proposals launched by the IMI. Researchers say "muted participation" from academia will affect the standard of medicine research projects funded under the initiative.
The university group claims that the European Commission, industry and the IMI have done little to address these concerns over the past two years, despite repeated complaints from academic institutions.
However, the IMI told EURACTIV that 155 universities and 24 SMEs are taking part in projects as part of the first call for proposals. There is "clearly no lack of participation," according to the Initiative, which adds that the response rate to the second call was even better.
Researchers want reimbursement for all costs
The IMI, which is jointly funded by the European Commission and the European Federation of Pharmaceutical Industry Associations (EFPIA), offers less attractive terms to researchers than other EU projects, the academics said.
Universities involved in the IMI are paid out of Brussels' framework programme (FP7) budget but the funding rules deviate from typical European research funds, according to LERU.
In its letter, academics say top scientists will shy away from the initiative unless the full cost of projects are reimbursed in the same way as other FP7 grants. Leading research institutions have professionalised their accounting structures in recent years but are now being penalised by the funding mechanism that underpins the IMI, according to LERU.
In response, the IMI said its priority is boosting innovation in the medicines sector, but said funding arrangements are a matter for the EU executive.
Intellectual property regime 'favours industry'
Universities also complain that the IMI's intellectual property policy is vague and skewed in favour of industry. This is a major stumbling block in all IMI project agreements, according to the academic group, which says a third call for proposals should be put on ice until the dispute can be resolved.
"The European Commission and EFPIA [European Federation of Pharmaceutical Industries and Associations] should not expect their 'partners' to accept rules, by which they basically give away all their IP [intellectual property] for free and do not even receive full funding for their research activities," the academics argue.
"As a consequence, several LERU members and other research institutions have implemented stringent procedures for scientists who wish to participate in an IMI proposal, with the effect that most of them withdraw before submission because academic participation is just not feasible."
Researchers also hit out at the bureaucracy and "opaque management layers" at participating pharmaceutical companies, claiming high staff turnover and inexperience has led to "general confusion as to who is responsible for what".
IMI dismisses criticism
Michel Goldman, executive director of the IMI, said the intellectual property regime developed for the initiative was drawn up to accelerate discovery and development in the pharmaceutical sector.
"A specific IP policy was designed to promote swift disclosure and exploitation of new knowledge by foreseeing access rights to third parties, as some third parties may be in a better position to ensure swift and appropriate dissemination and exploitation," he said, adding that the exact conditions are agreed on a project-by-project basis.
"Applicants who favour exclusive licences may disagree with this policy but it is a basic principle in IMI," said Goldman.
He said he is aware that some organisations have concerns and the IMI is currently finalising a guidance note to help applicants negotiate on intellectual property.
The IMI has had a letter published in the journal Nature, defending its policy on intellectual property after scientists had criticised the regime.
Goldman argued that the problems stem in part from misunderstandings about how knowledge sharing is handled in collaborations between academia and industry.
Launched in 2007, the Innovative Medicines Initiative (IMI) is a public-private partnership aimed at supporting more efficient discovery and development of better medicines for patients by removing research bottlenecks in the current drug development process.
The total IMI budget for the period 2008-2017 is €2 billion (€1 billion from the European Community and €1 billion from industry).
The first call for proposals under the IMI was launched in April 2008. 134 proposals were submitted, of which 15 have been selected to receive a total of €246 million (EURACTIV 19/05/09).
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- Nature:Clarifying knowledge ownership in Europe's medicines initiative (subscription)(26 Aug. 2010)