A group of leading European researchers has strongly criticised the European Union/European Federation of Pharmaceutical Industries and Associations (EU/EFPIA) Innovative Medicines Initiative (IMI), saying it  “shows how a private-public partnership (PPP) should not be set up.”

Launched in 2007, the IMI is the largest public-private partnership in life sciences R&D worldwide, with funding totalings 2 billion euros to 2017, contributed equally by the EU and the industry. But researchers have repeatedly criticised its intellectual property (IP) rights policy and funding model, and a letter sent to the IMI board this month by the League of European Research Universities (LERU) says the problems in these areas “represents a double negative” to participation by academia or small and medium-sized enterprises (SMEs).

LERU also criticises the European Commission, EFPIA and the IMI Joint Undertaking for having “done little” to address the concerns about these issues which have been “expressed by a multitude of academic institutions” right from the beginning.

The group tells the IMI board that its funding model is unattractive to universities and research organisations because its rules deviate from the usual EU FP7 (Seventh Framework Programme) funding mechanism, resulting in loss-making projects for them. The funding rules for academic institutions need to be adjusted “at the very least” to be in line with FP7 rules, it says, and warns that: “IMI cannot attract the most excellent scientists by underfunding their participation.”

Turning to the IP issue, LERU claims that: “under the window-dressing of IMI” as a PPP, a new IP policy was introduced, without consulting academic institutions, that saw “a clear push towards providing advantages to the EFPIA partners.”

Then followed by a Project Agreement template drafted by the EFPIA partners that followed the same IP principles “to the extent that EFPIA lawyers and contracts specialists refused to even negotiate them,” says the League.  “It is one thing for EFPIA lawyers to agree to such terms but it another thing entirely to assume academic institutions – and SMEs – would simply accept such unfavourable terms without even the pretence of negotiation,” it adds.

The way most of these negotiations were conducted showed “without doubt that IMI is not about equal partnerships,” according to LERU. It also says that researchers’ attempts to negotiate with EFPIA companies are made more difficult by “opaque management layers…. considerable staff turnover and little experience amongst EFPIA staff of dealing with IMI or similar research projects.” There is “general confusion as to who is responsible for what,” it says.

The European Commission and EFPIA should not expect their “partners” to “accept rules by which they basically give away all their IP for free and do not even receive full funding for their research activities,” LERU concludes, and states that the IMI’s planned third call for research proposals, due this autumn, should not be published until these issues have been resolved. The first call was launched in April 2008, and of the 134 proposals submitted, 15 were selected earlier this summer, receiving a total of 281 million euros. The second call has produced 124 expressions of interest.

- In July, a joint statement expressing similar concerns was issued by a group of 12 leading university and research organizations, all IMI stakeholders. Responding in a letter published in Nature on August 26, Michel Goldman, executive director of the IMI, said that criticism of the Initiative’s IP policies “partly reflects a misunderstanding about how knowledge-sharing is handled in collaborations between academia and industry.”