In an open letter the League of European Research Universities (LERU) has criticised plans for the second stage of the Innovative Medicines Initiative - IMI 2 - as the public-private partnership gears up to move forward under the Horizon 2020 programme. According to LERU the rules on funding and intellectual property rights will discourage academics from taking part in the project, which aims to speed up drug discovery and development in Europe.
Harmonising IMI 2 Financial Rules with Horizon 2020
While LERU welcomes steps taken by the European Federation of Pharmaceutical Industries and Associations (EFPIA), which leads IMI on the industry side, to eliminate differences between financial rules in IMI and the Framework Programme 7 (FP7), it claims the majority of IMI’s academic partners operate at a financial loss, receiving 75 per cent of direct costs for research and 20 per cent of indirect costs. “Academic partners are thus making a substantial financial contribution towards each IMI project, a point which is rarely acknowledged (if even realised) by industry partners.” the letter says. LERU wants to see IMI brought into line with FP7 and with the proposed rules for Horizon 2020, “in order to ensure the feasibility of future university participation in IMI”.
Section 4 of the current IMI Financial Guidelines states that “EFPIA companies are allowed to make financial contributions to beneficiaries (academic partners, SMEs) in the same project to reimburse part of the beneficiaries’ eligible costs. This financial contribution will be considered as part of EFPIA’s in-kind contribution and be recorded as such. Most likely, this financial contribution will be subject to a bilateral agreement between EFPIA and the beneficiary.” LERU sees this additional agreement as another layer of complexity and would prefer to see consistent reimbursement rates and rules for all Private Public Partnerships under Horizon 2020.
Balance in Intellectual Property
LERU also complains that the IP terms of the IMI Grant Agreement and its model Project Agreement favour the interests of the pharmaceutical community “over and above” those of academic partners, with a pre-agreed stance on IP putting universities in a difficult position.
“The IP terms seem to concentrate on the marketing of pharmaceutical and diagnostic developments by EFPIA partners, rather than giving equal weight to the interests of academic or SME partners, which might be to undertake further research or to put the results in the public domain,” the letter says. “The Commission funds universities in IMI to carry out research on priority areas identified by the pharmaceutical industry which in turn can take those results anywhere, including outside the EU – and all on IP terms which are extremely favourable to industry. That is not a reasonable ‘balance’.”
LERU says the loss of control of IP is a significant concern, with access rights being granted to IMI project companies and to any of their affiliates, which may not have been involved in the project. These affiliates do not have to specifically request the rights from an IP owner, meaning that academic institutions may lose the ability to control and track the whereabouts and use of potentially extremely valuable IP, says the letter.
Meanwhile, the IMI Grant Agreement does not allow for the restriction of access by third parties to background or foreground for research use. “The effect is that the IMI Grant Agreement encroaches on a Party’s ability to deal with its own Background, that is anything that was created before entering into a project, and this encroachment and encumbrance on pre-existing knowledge is significantly at odds with the FP7 rules and the rules of other public funding bodies,” says LERU’s letter.
LERU concludes that “IMI should not put academic institutions in a position where their concerns about the risks will encourage non participation.” Further consideration should be given to the unfavourable reimbursement rates and IP provisions to provide a clear balance of rights and obligations amongst all participants.