Joint Statement on the Innovative Medicines Initiative (IMI)

The Innovative Medicines Joint Technology Initiative (IMI) was launched in May 2007. From the beginning, significant stakeholder groups have expressed concerns about IMI’s intellectual property rights policy and its funding model. These concerns have been repeated on several occasions and have been transmitted to the IMI Member States Group, the IMI Joint Undertaking (JU) Governing Board and the European Commission.

The IMI JU is currently reviewing its intellectual property policy and the funding rules for reimbursement of indirect costs. A group of IMI stakeholders has decided to publish this joint statement to provide useful input in this review process and ensure that long-standing concerns from all key stakeholders are addressed.

The IMI JU has already launched two calls for proposals and is preparing a third call. Participation in the first two calls has been well below potential, because many organisations – SMEs, research organisations and universities – have not participated fully as a result of concerns regarding the complex and potentially un-balanced IMI IP policy and unattractive funding model. The programme is unlikely to achieve its objectives if participation remains sub-optimal.

Stakeholders wish to see IMI’s IP policy revised in order to provide for:

• reasonable definition of research use and of access rights for third parties;
• less extensive access rights for participants and affiliated entities worldwide, or at least better control of access rights by the owner;
• fair conditions for access (time limit, request in writing, fair and reasonable terms rather than royalty free);
• and more balanced and reasonable conditions  for licensing, assignment and other disposal of own assets, following the FP7 model (II.26.3 IMI GA).

These central issues have also been identified by the IMI IP Working Group but a resolution is still pending.

With the deadline for the third call rapidly approaching, it is crucial that real improvements are introduced as a matter of urgency.

The IMI funding model needs to be sufficiently competitive to attract the best players and to allow SMEs to engage effectively in large numbers. The recent report by the JTIs’ Sherpa Group [1] recognises stakeholder concerns and points the way forward. It recommends that “funding rates [...] should be set at levels comparable to those of the Framework Programme”[2]. The Sherpa Group has also recommended that “JTIs should implement measures to more effectively engage the SME community”[3].

IMI funding rules should be modelled on FP7 funding rules and the starting point for calculating funding rates should be coverage of the full costs of research. The current 20% cap on the reimbursement of indirect research costs ignores economic reality and must be lifted as a matter of urgency.

The undersigned stakeholder organisations believe that the necessary reforms must be implemented in time for the third IMI call for proposals. This is essential if IMI is to achieve its objectives of fostering long-lasting and fruitful collaborations between research organisations, SMEs, universities and pharmaceutical companies[4] and if we are serious about creating biomedical R&D leadership in Europe to benefit patients and society[5].   

[1] Designing together the ideal house for “public-private” partnerships in European research, JTI’s Sherpa Group, January 2010 - ftp://ftp.cordis.europa.eu/pub/fp7/docs/jti/jti-sherpas-report-2010_en.pdf

[2] Cf. Recommendation 3.2

[3] Recommendation 2.6

[4] SEC(2007)568 - “Companies small and large, regulators, governmental institutions, academics and patients need to come together to share resources and expertise to address the challenges of drug discovery and development.” - http://imi.europa.eu/docs/comm_pdf_sec_2007_0568_1_en_documentdetravail_en.pdf

[5] IMI vision: “Creating Biomedical Research & Development leadership for Europe to benefit patients and society” - http://www.imi-europe.org/Pages/topic.aspx?Item=9&ListId=DA41E506-DF1A-46A3-A541-548CE8F0D9B5