Establishment of the Innovative Medicines Initiative Joint Undertaking

2007/0089(CNS)

The Commission presents its second interim evaluation of the Clean Sky; Fuel Cells and Hydrogen and Innovative Medicines Initiative Joint Technology Initiatives Joint Undertakings.

This report summarises the findings and main recommendations provided by the panels of independent experts (IEGs) who conducted the evaluations.

The overall conclusion is that the Joint Undertakings have been successful in achieving their objectives, that they are relevant to the challenges of Horizon 2020 and they should be continued. The second interim assessments show that the existing Joint Undertakings have successfully demonstrated the viability of the Public Private Partnership (PPP) concept for research in strategic technological areas. They have been effective in delivering on the main objectives and have been able to reinforce Europe’s role in aeronautics, pharmaceutics and fuel cell and hydrogen R&D.

More specifically, the report presents the Commission’s observations and recommendations and highlights the areas in which follow-up actions should be planned.

Implementation of the IMI initiative: according to the IEG, the Innovative Medicines Initiative8 has successfully demonstrated its effectiveness in reinforcing Europe’s attractiveness for pharmaceutical R&D, in pooling resources and stimulating stronger engagement and involvement from various stakeholders, and stimulating new technologies and methodologies to accelerate medicines development. In

particular, the evaluation reports on the high quality and scientific excellence of the projects.

As regards financing, a maximum EUR 1 billion contribution was allocated from the FP7 budget. There have been 10 calls for proposals so far for an overall project portfolio of approximately 40 running projects. The 11th and final call was launched on 11 December 2013.

Commission’s observations: the Commission acknowledges the IEG recommendations for further improvements in the organisational structure of the IMI Executive Office to ensure a suitable balance between administrative and scientific staff. Moreover, IMI should identify possible skills or competency gaps in the office with a view to improvements. The Commission supports the recommendation to continue planning and designing new funding mechanisms to ensure the sustainability of current and future projects, whenever appropriate and aligned with Horizon 2020 rules.

As regards governance and participation, the Commission welcomes the recommendation of encouraging the sharing of good practices. It also Commission has addressed this in its proposal for Innovative Medicines Initiative 2 under Horizon 2020.  The IEG also observed that IMI projects could benefit from the participation of medium-sized pharmaceutical companies that are too big to be SMEs but are not EFPIA members.

The Commission takes note that the IEG suggested to use the possibility to include non-EU in-kind contributions as part of the total in-kind contribution. The Governing Board has already taken action by requesting that IMI ‘scientific ambassadors’ be identified and appointed in each country. The Commission agrees that the Key Performance Indicators (KPIs) need further sharpening.

Perspectives: the Commission acknowledges the thorough and in-depth work carried out by the IEGs in undertaking the second interim evaluation of the three Joint Undertakings. It also notes that the IEGs recognised the validity of the PPP approach and expressed positive views about the future prospects for Joint Undertakings under Horizon 2020.

The IEG recommendations are considered valuable for removing or at least reducing the weaknesses identified in the current Joint Undertaking operations. The Commission undertakes to implement corrective measures when appropriate and within its powers of intervention whilst recalling that implementing the recommendations addressed to the next generation of joint undertakings requires the adoption of new Council Regulations.

Since 10 July 2013, when the Commission presented its proposed Regulations, the processes for continuing the JUs are fully underway.