Table of Contents

1. INTRODUCTION.. 3

2. BACKGROUND.. 3

3. THE EVALUATION PROCESS. 5

4. SUMMARY OF THE EVALUATION RESULTS AND RECOMMENDATIONS. 5

4.1. Clean Sky. 6

4.1.1. Organisation of the Joint Undertaking and relations with stakeholders. 6

4.1.2. Research Agenda implementation. 6

4.2. Fuel Cells and Hydrogen. 7

4.2.1. Organisation of the Joint Undertaking and relations with stakeholders. 7

4.2.2. Research Agenda implementation. 7

4.3. Innovative Medicines Initiative. 7

4.3.1. Organisation of the Joint Undertaking and relations with stakeholders. 8

4.3.2. Research Agenda implementation. 8

4.4. SWOT ANALYSIS. 8

5. COMMISSION RESPONSE TO THE IEG REPORTS. 10

5.1. Clean Sky. 10

5.1.1. Recommendations on organisation and efficiency. 10

5.1.2. Recommendations on progress and effectiveness. 11

5.2. Fuel Cells and Hydrogen. 12

5.2.1. Recommendations on organisation and efficiency. 12

5.2.2. Recommendations on progress and effectiveness. 12

5.3. Innovative Medicines Initiative. 13

5.3.1. Recommendations on organisation and efficiency. 13

5.3.2. Recommendations on progress and effectiveness. 14

6. CONCLUSIONS. 16

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS

Second Interim Evaluation of the CLEAN SKY, FUEL CELLS AND HYDROGEN and INNOVATIVE MEDICINE INITIATIVE Joint Technology Initiatives Joint Undertakings

1. INTRODUCTION

This report summarises the findings and main recommendations provided by the panels of independent experts who conducted the second interim evaluations of the following Joint Technology Initiatives (JTIs): Clean Sky; Fuel Cells and Hydrogen; and Innovative Medicines Initiative. It also presents the Commission’s observations and highlights the areas in which follow-up actions should be planned. With this report, the Commission complies with the requirements under Article 11 of each Council Regulation establishing the above-mentioned Joint Technology Initiatives.[1]

Information on the three Independent Expert Groups (IEGs) that performed the evaluations and on the SWOT analysis (strengths, weaknesses, opportunities, and threats) run for each JTI is provided in the annexes. The annex also includes a full list of recommendations delivered by the IEGs. The full individual reports are published in the corresponding Joint Undertaking website.

2. BACKGROUND

The Seventh Framework Programme for Research and Technological Development (FP7) proposed the establishment of long-term public-private partnerships — as JTIs — to be implemented through Joint Undertakings (JUs) within the scope of Article 171 of the Treaty establishing the European Community (now Article 187 of the Treaty on the Functioning of the European Union) and defined specific criteria to identify them. A number of strategic technological areas were identified and Public Private Partnership (PPPs) between the European Commission and industry were set up. This Report focuses on the following PPPs:

The Clean Sky Joint Undertaking (CS JU) is the PPP between the European Union (represented by the Commission) and the aeronautics industry. Its main objective is to develop environmentally friendly technologies — thereby contributing to the ACARE 2020 targets[2] to reduce emissions and noise in air transport in Europe — for all flying segments of commercial aviation.

In Clean Sky, the industry is represented by 12 industry leaders and currently 66 associated members. Alongside the members, there are more than 400 partners selected through open calls for proposals and working on specific tasks. All members and partners work together in a number of technology domains that have been integrated into six Integrated Technology Demonstrators (ITD) and a Technology Evaluator programme with the aim of assessing the performance of the technologies developed under Clean Sky.

The Fuel Cells and Hydrogen Joint Undertaking (FCH JU) is the PPP between the European Union (represented by the Commission), the fuel cell and hydrogen industries (represented by the NEW-IG Industry Grouping), and the research community (represented by the N.ERGHY Research Grouping). Its main goal is to accelerate the introduction of fuel cells and hydrogen technologies into the market to fulfil their potential as an instrument in achieving a carbon-lean energy system. The Innovative Medicines Initiative Joint Undertaking (IMI JU) is the PPP between the European Union (represented by the Commission) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Its objectives are to build a more collaborative environment for pharmaceutical research and technological development (R&D) in Europe, and to develop more effective and safer medicines while increasing the competitiveness of the EU pharmaceutical sector.

Clean Sky has a budget of € 1.6bn with a maximum EU contribution of € 800m of which at least € 200m is allocated to calls for proposals. By September 2013, 14 calls for proposals had been evaluated and a portfolio of projects was subsequently selected. At the time of the assessment, the project portfolio counts 349 projects for which grant agreements had been signed. The evaluation of the 15th call for proposals was ongoing and the 16th and final call was planned to be launched before the end of 2014.

Fuel Cells and Hydrogen has a maximum EU contribution for research activities of € 470m. So far, six annual calls for proposals have been launched and a portfolio of projects was subsequently selected. Under the first five calls, approximately € 380m was committed across 131 projects. Negotiations for the 71 projects submitted under the 2013 call for proposals, with a total indicative funding of about € 68m, were still ongoing as this second interim evaluation was being carried out.

With regard to Innovative Medicines Initiative, a maximum € 1bn 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.

In accordance with the requirements of the Council Regulations establishing the JTI JUs, a first set of interim evaluations was carried out in 2010 and 2011. A second set, which is the subject of this report, was completed before the end of 2013. The Commission response to the first interim evaluation reports was included in its Partnering Communication.[3]

3. THE EVALUATION PROCESS

The second interim evaluations of the three Joint Undertakings were performed in parallel. Coordination of the evaluations was particularly important in view of the transition from FP7 to Horizon 2020 along with the ongoing process for the continuation of these initiatives.

The objective of this evaluation was to assess the effectiveness, efficiency and quality of the operations, both with regard to their operating bodies and their activities.

To this end, the Commission invited a number of independent experts to produce a report based on a review of evidence and interviews of selected stakeholders in each technological area. To ease the assessment of horizontal and common issues, one expert was common to the three Independent Expert Groups (IEGs).

After kick-off meetings in Brussels in March 2013, the evaluations ran for an average of five months. They were performed with a combination of work done remotely, conference calls, a number of meetings, and interviews with a wide range of stakeholders. In the case of Fuel Cells and Hydrogen, a web-based survey of project coordinators was also undertaken. For Clean Sky, there were several site visits to the companies and facilities within a selection of ITDs to assess the strategy and the work done in preparation of the demonstrators.

In addition, internal documents and information available online, including a set of EU policy documents, were analysed.

The reports from the IEGs were issued in July 2013 (Fuel Cells and Hydrogen), August 2013 (Innovative Medicines Initiative) and October 2013 (Clean Sky). This second round of interim evaluations supported, when relevant, the legislative process on the setting up the next generation of JTI JUs.

4. SUMMARY OF THE EVALUATION RESULTS AND RECOMMENDATIONS

The overall conclusion of the IEG reports 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 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.

Looking ahead, the experts consider that some issues can be improved and have therefore made a series of recommendations to remove or reduce weaknesses identified in the current operations of each Joint Undertaking and to improve their effectiveness, efficiency and quality.

4.1. Clean Sky

The IEG concluded that the research undertaken in Clean Sky[4] is of high quality. Already, a number of demonstrators are running or have been tested. In many cases, the preliminary assessments of the environmental benefits confirm the capability of achieving the targets by the end of the programme.

4.1.1. Organisation of the Joint Undertaking and relations with stakeholders

Concerning organisation and efficiency in the use of resources, the report states that overall governance is efficient in programme management and in delivery of calls and projects. The IEG is convinced that Clean Sky has created an effective dialogue between industry, including SMEs, and the research and academic communities around a common strategic programme, and has successfully implemented it. However, the IEG considers that existing links with both SESAR[5] and ACARE[6] should be enhanced and that Clean Sky should have a better view about airlines, Air Navigation Services Providers (ANSPs) and other stakeholders.

In terms of running the Executive Office, the IEG found that there is still room for improvement in reducing administrative work, increasing organisational efficiency and enhancing internal and external communication. There has been, nonetheless, significant progress in speeding up processes and reaching higher operational efficiency. The report gives a recommendation for additional adjustments to further improve the efficiency of the Executive Office. Moreover, now that Clean Sky is well established, the balance of skills in project management needs to be improved.

4.1.2. Research Agenda implementation

Regarding technical progress, the report states that despite initial delays due to its slow start, Clean Sky shows satisfactory progress in meeting its set objectives and has a clear, open and non-discriminatory attitude towards a wide community of stakeholders. In particular, the strategy (i.e. methods, processes and tools) used — to launch and manage the calls for proposals, select the best proposals, promote participation of SMEs and increase the rate of new entries in the Joint Undertaking and calls for proposal — has proved to be effective.

The technical development of the demonstrators is also progressing satisfactorily. It is noted that by the end of Clean Sky, the demonstration programmes will provide evidence of the integration in practice of several technologies and indicate the potential benefits in a relevant operational environment.

4.2. Fuel Cells and Hydrogen

On Fuel Cells and Hydrogen,[7] the coupling of the long-term commitment by the EU and the stable funding provided through the instrument have allowed the Joint Undertaking to give confidence to the industry and support the sector in bridging the gap between research and deployment.

4.2.1. Organisation of the Joint Undertaking and relations with stakeholders

The IEG recognises that project management is efficient and appreciated by participants; nevertheless, it was recommended to reduce overheads. The FCH governance structure is seen as adequate, but with room for improvement, notably at the level of decision-making and cooperation with Member States. Lastly, the IEG also recommended that the Joint Undertaking improves in the area of communication.

4.2.2. Research Agenda implementation

Regarding technological progress, the evaluation found that developments resulting from the research conducted in Fuel Cells and Hydrogen have ensured market improvement (e.g. by reducing costs and improving performance and life span of components). The report highlights that demonstration projects, particularly in the transport sector, have strengthened knowledge and confidence. While the quality of the work performed is perceived as comparable to that performed under the rest of FP7, the impact on policy (a key to the success of fuel cells and hydrogen technologies) is perceived as limited, most probably because of the early stage of research activities (only a few projects have been finalised). Nonetheless, the experts recommend that the mechanisms and links between research and policy be revised and that communication with the Commission services in charge of policy development be improved. They also recommend that access to financing resources be facilitated to enable the necessary large-scale demonstrations required for market take-up of these technologies. At the same time, there should still be room for breakthrough research activities.

4.3. Innovative Medicines Initiative

According to the IEG, the Innovative Medicines Initiative[8] 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.

4.3.1. Organisation of the Joint Undertaking and relations with stakeholders

In the process of assessing Innovative Medicines Initiative’s efficiency, the IEG analysed the Key Performance Indicators (KPIs), the governance structure and processes, the communication strategies and the use of funding. One of the main conclusions is that the KPIs should be further developed to better measure and reflect Innovative Medicines Initiative’s overall objectives. There is also a need for the long-term strategy to better evaluate the general impact of IMI on the biopharma industry, the healthcare system and the European economy.

Furthermore, the report points out that the communication strategy needs further development to reach different groups with a targeted message. This would address the lack of visibility of IMI among specific groups within the scientific community.

Although the IEG considered significant progress had been made to improve the functioning of the Executive Office, there are still a number of organisational and human resources issues that can be improved.

4.3.2. Research Agenda implementation

Regarding the implementation of research and development activities, the IEG noted that there are still misconceptions on intellectual property matters, although the perception of the problem varies significantly among stakeholders. The IEG appreciated the efforts made to explore a new funding mechanism, e.g. through the calls for proposals for exploitation of new scientific opportunities (ENSO), which have delivered beyond expectations.

4.4. SWOT ANALYSIS

To place the evaluation in a broader context and to help draw conclusions, the IEG experts performed SWOT analyses of the JTI Joint Undertakings. From the individual strengths, weaknesses, opportunities and threats, a number of common features, in particular regarding strengths and weaknesses, have been detected. This analysis is robust, since it explicitly covers three of the five JTI joint undertakings set up under FP7. The report from the Commission on the second round of interim evaluations for the other two JTI joint undertakings under the responsibility of DG Communications Networks, Content and Technology has already been published[9] and the conclusions are in line with those presented here.

In general, the strengths in current JTI JUs confirm that PPPs are a successful cooperation model to address non-competitive challenges in specific technologies. JTIs are a valid instrument to achieve agreement on strategic research agendas and potentially more efficient use of research budgets. Another strength is the capability to create and maintain strong communities across industry, research organisations and academia by widening the network of stakeholders involved, creating a critical mass of expertise to address the most complex problems and delivering high-quality scientific output. The mobilisation of resources and the growth of synergies have also proven to be an asset.

Clean Sky has put in place an effective governance structure and proactive participation of advisory bodies; Fuel Cells and Hydrogen and Innovative Medicines Initiative should reinforce these aspects.

As to the weaknesses, the analysis highlights that the balance between scientific and administrative staff in the Executive Offices of the Joint Undertakings can still be improved. However, this has to be considered in the broader context of the concept of the JTI joint undertakings: these are, by design, small bodies that have to provide a full range of services in support of research and demonstration activities. This has an impact on the possibility to improve the balance between administrative and scientific tasks and to rebalance staff skills internally.

In this respect, the Commission’s proposed Council Regulations[10] include measures to help the Joint Undertakings to rationalise some administrative tasks and to benefit further from the common services offered to the whole family of bodies implementing Horizon 2020.

Moreover, the IEGs commented on the lower participation of certain categories of stakeholders (i.e. SMEs, EFPIA companies) and the measures to be taken to broaden the scope of the initiatives. The current level of coordination with regional, national and international initiatives and policies is seen as limited and should be improved. These observations on participation and coordination on different levels of intervention and policies are quite specific to JTIs; the monitoring of improvements, however, is in the remit of the Commission.

Where relevant, the set of KPIs established in each JTI JU has been considered insufficiently mature, limiting the possibility of demonstrating both the broader socio-economic and environmental impact and the achievements towards objectives at programme level. This latter factor may in particular threaten the political support for the, JTI Joint Undertakings.

Finally, the common threat identified is the potential rising of a negative perception on JTI Joint Undertakings among major stakeholders.

5. COMMISSION RESPONSE TO THE IEG REPORTS

The Commission welcomes the IEGs conclusions that the Joint Undertaking is an appropriate setting to implement research and demonstration in specific important sectors and that it should be continued. The Commission is committed follow up on the recommendations addressed to it and to work together with other stakeholders and bodies on the recommendations addressed to them. Generally, the Commission agrees with the IEG assessments and conclusions and with most of the specific recommendations. Many of the recommendations have already been addressed in the Commission’s proposals for JTI Joint Undertakings under Horizon 2020.

5.1. Clean Sky

The Commission notes the IEG conclusion that, despite the slow start, Clean Sky has accelerated its activities and is now running at full speed. Even though not all delays have been fully recovered, all planned implementation will be achieved. The Commission acknowledges the IEG position and is reassured that Clean Sky is in line with the achievement of its objectives.

5.1.1. Recommendations on organisation and efficiency 5.1.1.1. Appropriateness of the Joint Undertaking internal rules and funding

In general, the Commission acknowledges the IEG opinion that the decision-making process should be accelerated, but at the same time underlines that the streamlining process should be undertaken within the bounds of Rules for Participation and the Financial Regulation, thus maintaining control and allowing total transparency on the use of public funds.

5.1.1.2. Efficiency of the Executive Office organisation and procedures, including monitoring

The Commission agrees that extending the Joint Undertakings is an opportunity to streamline their use of administrative and technical resources. It is however important to note that this rationalisation process is to be seen and carried out in the wider context of the implementation of Horizon 2020 under which the JUs are means to achieve the objectives set by the legislator.

5.1.1.3. Efficiency of communication

The Commission agrees that communication should become a central channel of the Joint Undertaking internal and external synergies. It is determined to provide its support in the achievement of that goal. It is important to step up effective communication activities and target the general public, sectoral representatives, decision-makers and international communities. The Commission agrees with the IEG that very good results have been achieved so far and that the current status is an important starting point for further improvements in communication. Besides, the Commission agrees that links between SESAR JU and Clean Sky should be strengthened and it is ready to work with both Joint Undertakings to improve the communication and reinforce synergies and complementarities.

The Commission is also committed to work closely with Clean Sky and all stakeholders including Member of the National State Representative Group in order to raise global awareness and visibility of Clean Sky 2.

5.1.1.4. Quality of calls for proposals

The IEG recognises that the call for proposals procedure and implementation have been effective and commensurate to the role of partners in the Clean Sky technical programme. The Commission agrees that this approach should continue and the calls process should remain an important contributor to reaching the specific objectives in the even more ambitious Clean Sky 2. The IEG considers that further work should be done in systematically reviewing the technical content of calls and the Commission is prepared to contribute to achieving this goal.

5.1.2. Recommendations on progress and effectiveness 5.1.2.1. Overall progress and effectiveness

The Commission agrees with the IEG conclusion that Clean Sky 2 should become the focal point of a pan-European demonstrator-based innovation programme in aeronautics. Capitalising on the successful implementation of Clean Sky in FP7 is necessary when striving to meet environmental and competitiveness targets. The Commission highlights that such environmental targets and progress in meeting them have to be aligned to other initiatives that support its environmental policy.

The Commission notes that the IEG reported that the strategy and preparation of the final demonstrator phase, including flight tests, has been exemplary. At the same time, the IEG pointed to the need for a more intensive correlation between Clean Sky objectives and the overall objectives of the aeronautics sector as set out in the European Technology Platform ACARE. The Commission shares the IEG position and will explore the possibility to develop further a methodology to assess the progress towards ACARE goals.

5.1.2.2. Site visits

The IEG acknowledges that site visits have provided first-hand experience of the progress made by Clean Sky and of how the results obtained have met the specific objectives. The Commission accepts the IEG position and recommendation to ensure that site visits are contemplated in future assessments.

5.1.2.3. Technology Evaluator and policy needs

The Commission notes the current horizon of the Technology Evaluator, which is geared to technological assessments. The Commission would welcome widening the scope of the Technology Evaluator tools development.

5.2. Fuel Cells and Hydrogen 5.2.1. Recommendations on organisation and efficiency 5.2.1.1. Governance and stakeholder engagement

The Commission agrees that decision-making procedures should be as swift as possible, but underlines that proper deadlines should be ensured in the organisation and preparation of Governing Board (GB) meetings. It should be noted that the Commission vote in the GB is indivisible, and that sufficient time should be allowed for it to run its inter-service consultation process to reach an agreement across all services involved. The current deadlines for provision of documents for Governing Board meetings and responding to written procedures respect this need.

The EU will, as a member of the Governing Board, monitor the proper allocation of resources, the continuous commitment from members and the efficient application of procedures. The authority of the Executive Director is limited in matters where the Commission has a veto right (generally matters of public spending) and which should therefore remain for the GB to decide. The Commission supports the proposal to reinforce the role of and to improve the flow of information with the States Representatives Group.

5.2.1.2. Administrative design and management

The Commission’s proposed Regulation for Fuel Cells and Hydrogen 2 includes the possibility of sharing a set of administrative functions. Given the autonomous nature of the Joint Undertakings, however, it would not be possible for the Commission to re-claim the functions as proposed by the IEG. The Commission is willing to explore options on how industry expenditure can be monitored, where this is compatible with the overall simplification approach enshrined in Horizon 2020.

5.2.2. Recommendations on progress and effectiveness

On the subject of funding, the Commission agrees with the proposed measures. The new proposed Regulation for Fuel Cells and Hydrogen 2 provides that the JU will indeed have access to the guarantee fund, which implies that the participation of SMEs will be facilitated.

As regards work programmes, a new effort to improve synergies and interactions with other relevant areas will be undertaken. Actions have already been taken to maximise alignment between work programmes, both concerning the first calls under Horizon 2020 and the activities of the European Green Vehicles Initiative.

The Commission is willing to explore how to streamline interactions between its services in charge of policy definition and the JU in order to guarantee that the activities of the JU are more relevant to the policy areas. It will also ensure that scientific evidence is consistently incorporated in transport and energy policy areas.

The ERA-NET scheme[11] and the European Energy Research Alliance (EERA) Joint Programme on Fuel Cells and Hydrogen may be considered as appropriate instruments to coordinate and integrate national and regional activities in this field, and might be effective partners for the Fuel Cells and Hydrogen joint undertaking.

The Commission will investigate the possibility to include hydrogen infrastructures in the new National Strategic Reference Framework (NSRF) for Structural Funds.

5.3. Innovative Medicines Initiative 5.3.1. Recommendations on organisation and efficiency 5.3.1.1. Organisational structure and funding mechanisms The Commission acknowledges the IEG recommendations for further improvements in the organisational structure of the Innovative Medicines Initiative 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 IEG recommends that Innovative Medicines Initiative should examine whether some administrative and horizontal functions can be shared with other Joint Undertakings, knowing that such an approach has already been taken up in the Commission proposal for Innovative Medicines Initiative 2. 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. 5.3.1.2. Governance and engagement of industrial stakeholders

The IEG encouraged the Commission to avail itself of the opportunity to use a cross-comparison to identify areas of best practice for the operational functions of the State Representatives Group and the scientific committee in the Joint Undertakings. The Commission welcomes this recommendation and encourages the sharing of good practices, in particular on matters related to governance and the role of the advisory bodies.

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. It was suggested that the JU should find the way to engage such companies in future projects. The Commission supports this observation, and has addressed this in its proposal for Innovative Medicines Initiative 2 under Horizon 2020. This includes the opening up of the partnership to companies beyond EFPIA associates and SMEs, explicitly including medium-sized companies.

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. It also notes that — to stimulate broader engagement of industry in Innovative Medicines Initiative — EFPIA has been recommended to follow up the suggestion.

5.3.1.3. Communication strategy and awareness raising

The Commission agrees that the Innovative Medicines Initiative Governing Board should make all possible efforts to finalise and implement the newly developed communication strategy, which would be linked to the IMI vision and its long-term policy framework. It will help to demonstrate the value of Innovative Medicines Initiative to stakeholders and beyond and subsequently attract both more involvement and more investment.

The Commission acknowledges EFPIA’s agreement to further develop targeted communication to a wide range of stakeholders, including the general public, patient organisations, and regulators. Shifting the focus from inputs and processes to outputs and impacts — to demonstrate the importance of Innovative Medicines Initiative’s work — is essential. This will also further increase IMI’s visibility, positively boost the Joint Undertaking’s image and generate public support.

The IEG recommended engaging members of the States Representatives Group to act as IMI ambassadors in their respective countries to enhance support and participation in future calls.

The Governing Board has already taken action by requesting that IMI ‘scientific ambassadors’ be identified and appointed in each country. They should be found among high-level key researchers who participate in IMI projects or who have a deep knowledge of its scientific activities. Their role would be to enhance awareness and achievements at national and regional level. A draft list of potential candidates selected from Innovative Medicines Initiative projects and former members of the Scientific Committee has been drafted.

The Commission appreciates the efforts made so far in involving SMEs and these should be continued. The Commission supports the IEG suggestions on targeted communication and messages concerning Intellectual Property policy issues and examples of SMEs that have benefited from participating in IMI projects.

5.3.2. Recommendations on progress and effectiveness 5.3.2.1. Key Performance Indicators (KPIs)

The Commission agrees that the KPIs need further sharpening, in line with the general approach that is set by the legislator for Horizon 2020. It is clear that the long-term strategy and the KPIs are needed to quantify the return on investment and to assess the value for money and opportunity cost of IMI. The Commission advocates that the aggregated KPIs should be monitored regularly and communicated broadly beyond the usual scientific and research communities.

5.3.2.2. Data and information availability

The IEG recommended that the Commission, together with EFPIA, should help to provide the information and baseline figures needed to develop aggregated KPIs. Overall, the Commission agrees with the IEG, but it also advocates a better mutual exchange of data for the benefit of policymaking within the Commission services.

6. CONCLUSIONS

The Commission acknowledges the thorough and in-depth work carried out by the IEGs in undertaking the second interim evaluation of the Clean Sky, Fuel Cells and Hydrogen and Innovative Medicines Initiative Joint Undertakings. In particular, it acknowledges the effort made by the IEGs to provide a cross-comparison of procedures in the three Joint Undertakings and — in the case of Clean Sky — to endure a heavy schedule of site visits to assess achievements at demonstrators’ level. It also notes that the IEGs recognised the validity of the PPP approach implemented through Article 187 initiatives and expressed positive views about the future prospects for Joint Undertakings under Horizon 2020. The Commission notes the satisfactory and effective consistency of views in the two interim assessments to date and acknowledges the IEGs’ recognition that most recommendations from the first interim evaluations in 2010 and 2011 have been implemented successfully.

The IEG recommendations are considered valuable for removing or at least reducing the weaknesses identified in the current Joint Undertaking operations. They are being taken into account, insofar as the legislative process allows, in establishing JTI joint undertakings under Horizon 2020 (i.e. Clean Sky 2, Fuel Cells and Hydrogen 2 and Innovative Medicines Initiative 2).

The Commission undertakes to implement corrective measures when appropriate and within its powers of intervention. It also commits to continue working together with other joint undertaking stakeholders and bodies to address the recommendations appropriately.

Finally, the Commission recalls 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 Clean Sky, Fuel Cells and Hydrogen and Innovative Medicines Initiative under Horizon 2020 are fully underway.

[1] Clean Sky: Council Regulation (EC) No 71/2008; Fuel Cells and Hydrogen: Council Regulation (EC) No 521/2008; Innovative Medicines Initiative: Council Regulation (EC) No 73/2008.

[2] ACARE targets (baseline 2000): (i) reduce fuel consumption and CO2 emissions by 50% per passenger kilometer; (ii) reduce NOx emissions by 80%; (iii) reduce perceived noise by 50% ; (iv) make substantial progress in reducing the environmental impact of the manufacture, maintenance and disposal of aircraft and related products

[3] See Commission Staff Working Paper SEC(2011) 1072 final and the Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Partnering in Research and Innovation (SEC(2011) 1072).

[4] http://www.cleansky.eu/sites/default/files/news/clean_sky_-_2nd_interim_assessment.pdf.

[5] http://www.sesarju.eu/.

[6] http://www.acare4europe.org/.

[7] http://www.fch-ju.eu/sites/default/files/2nd%20interim%20evaluation.pdf.

[8] http://www.imi.europa.eu/sites/default/files/uploads/documents/Governance/2ndInterimEvaluationIMI.pdf.

[9] COM(2013) 830.

[10]COM/2013/0496 Bio-Based Industries; COM/2013/0505 Clean Sky 2; COM/2013/0506 Fuel Cells and Hydrogen (FCH) 2; COM/2013/0501 Electronic Components and Systems for European Leadership (ECSEL) COM/2013/0495 Innovative Medicines Initiative (IMI) 2.

[11] The ERA-NET scheme is intended to step up the cooperation and coordination of research activities carried out at national or regional level in the Member States and Associated States.

http://ec.europa.eu/research/era/era-net-in-horizon-2020_en.html

Table of Contents

ANNEX I: IEGs RECCOMENDATIONS. 2

ANNEX II: SWOT Analyses. 11

ANNEX III: Composition of the Expert Evaluation Panels. 15

ANNEX I: IEGs RECCOMENDATIONS

Clean Sky

Recommendation || Responsibility

Progress towards environmental targets ||

CS1 and CS2 related: The current progress is reported in relation to CS objectives. The Panel recommends a more transparent traceability between the ACARE goals and the specific contributions from Clean Sky. || GB, JU

The Panel encourages the Partners and Project Managers to provide more clarity and consistency in the figures presented as well as on the assumptions taken for the evaluation of the environmental targets in relation to the ACARE goals. || GB, JU, Future PPPs

Coordination with FP7, SESAR and National Programmes ||

It is recommended to deepen the existing relationship with both SESAR and ACARE - at working group level –with the aim to reach a better understanding within the JU on airlines, ANSPs and other stakeholder communities. ||

The Panel believes that information exchange between the JU and NSRG is very important and recommends that the NSRG continues to play a crucial role in ensuring the coherence of national programmes with Clean Sky. || GB, JU, Future PPPs

Effectiveness in promoting participation ||

The Panel appreciates that Clean Sky does not require a consortium as a condition for participation to calls for proposals, single entities can apply, and that there are a number of mono-beneficiaries also amongst SMEs. The Panel however recommends making the high participation of SMEs and new players more visible (see also 3.5 Efficiency in Communication). || JU

Effectiveness of ITD and TE strategies ||

The Panel recognises that the TRL concept has been refined and recommends that CS JU disseminates the results across the R&D community. || JU

CS1 and CS2 related: The visits provided evidence on a very good cooperation between research development activities and flight test preparations. Detailed reviews have been conducted including multidisciplinary teams with experienced personnel in flight test. Moving from the example of the good GRA flight test preparation, the Panel recommends that the ITDs make greater efforts in communicating and disseminating best practices and encourages them to extract from successful cases of other ITDs useful lessons for own future activities. || JU, Future PPPs

Complementarity with other activities in Horizon 2020 ||

CS2 is an appropriate framework to implement and manage industry-led projects. It is important to devote a significant share of the budget to such projects, to bring technologies from TRL 3 to TRL 4 or at best 5, without the a-priori objective of contributing to a flying full scale platform demonstrator. || GB, JU, EC, Future PPPs

It is important that this type of industry-led project is run directly by the JU without interference from the big projects of higher TRL. || GB, JU, EC, Future PPPs

These projects should use the Technology Evaluator to provide inputs during the evaluation phase and to assess environmental impact and efficiency at the end of the projects. || GB, JU, EC, Future PPPs

Suitability of the CS legal framework and governance ||

The Panel recommends that the STAB role is preserved and enhanced for example in drafting future updates of the SRIA. Their contribution – also for a CS2 – is considered significant and it is recommended to ensure that high quality individuals are involved as it is the case in Clean Sky. || GB, JU, Future PPPs

Notwithstanding the valuable involvement of the advisory bodies, there is still room for a greater and more pro-active involvement of the STAB and the NSRG. The CS JU should seek to maximise the potential of its advisory bodies to gain support for the remaining calls and other activities at all levels. || GB, JU

Appropriateness of the JU internal rules and funding ||

The Panel emphasises that the Clean Sky JU also contributes to achieving the roadmaps that have been jointly agreed between all stakeholders and considers the multi-annual approach advantageous and recommends this is continued in the future. || GB, JU, Future PPPs

The Panel regrets that concerning the negotiation of a multi-annual GAM, there continues to be a need for more flexibility in the management of GAMs. In general, the Panel recommends more discretionary power to the Executive Director in management matters and believes that GAM budget transfers should be initiated, negotiated and implemented by the Executive Director. This step would help speeding up the implementation of necessary decisions since it would no longer be necessary to involve the Governing Board. || GB, JU, EC, Future PPPs

The Panel is aware that recommendations have been issued about the completeness and timing of the strategic planning (CSDP) and alignment with annual planning (AIP) and annual amendments of the GAMs. In this context, a specific finding has been raised by the Internal Audit Service (IAS) on the subsequent changes of topics compared to the approved AIP. The Panel endorses plans to delegate a number of decisions and functions from the GB to the ED for the approval of such changes in order to ensure the necessary flexibility for the JU to adapt the lists of topics to the actual needs during the year. || GB, JU, EC, Future PPPs

CS1 and CS2 related: The Panel considers that the existing possibilities to redistribute the budget amongst ITDs (as the transfer occurred in 2012 between ITDs) are an initial useful step towards providing some budget flexibility. The Panel regrets that there is still no contingency budget since this would enable transversal flexibility. Therefore the Panel recommends that the Governing Board considers introducing a 5-10% contingency budget. || GB, JU, EC, Future PPPs

The Panel is of the opinion that the verification of in-kind contribution is still a laborious and time-consuming issue to manage and negotiate and that the current procedure is not efficient. Therefore it recommends steps to simplify the procedure. || GB, JU, EC

Efficiency of the JU Executive Team organisation and procedures incl. monitoring ||

Although the Executive Office has made significant progress in speeding up processes and reaching operational efficiency, the Panel recommends that some further adjustments are be carried out to improve efficiency. Now that the Clean Sky JU is well established, the balance of skills between general administration and project management in the Executive Office need some readjustment. || GB, JU, EC

The Panel considers the number of the JU technical staff as being insufficient and recommends a review by the Governing Board of staff requirements to ensure that the Executive Team can exercise in full its coordinating and monitoring functions. At the same time the Panel recommends a review of potential services to be shared with other JUs and of administrative services that could be outsourced. || GB, JU, EC

The Clean Sky Executive Office should seek further ways of reducing bureaucracy and ensure that it has the optimal organisational structure for the tasks ahead. || JU

Although participation and success rate of the applications indicate that the performance of the JU in the administration of the programme, project management and programme design and implementation is adequate and capable, the Panel notes that the “Time to grant” is still rather high (240 days from call publication to GAP; 360 days on average for grants signed in 2012) and recommends this timeframe is shortened. || JU

The Panel acknowledges the value of the adopted system of 16 internal control standards and considers this a robust system for an efficient and effective management. The Panel appreciates that there is a satisfactory alignment of strategic and annual planning and recommends its systematic implementation. || JU

The Panel welcomes the intention of the JU (as in the GB meeting of 22.3.2013) to launch trainings for Topic Managers and endorses endeavours to increase the monitoring of the Project Officers and the administration team, to make sure delays and projects execution problems are tackled as soon as possible. These are important steps to address holdups currently limiting the overall efficiency. || JU

The Panel appreciates that in the evaluation period ex-post audits of financial statements of CS JU beneficiaries have been implemented and recommends that the efforts undertaken to reduce the error rates are continued. The Panel appreciates that the JU has put efforts into improving its ex-ante validation process and has provided guidance to its beneficiaries concerning the eligibility of costs for the Clean Sky projects. || JU

Efficiency of ITD organisations and procedures ||

The Panel appreciates that monitoring and control tools are mature and implemented and recommends harmonized progress activity reports and technical evaluation reports across the ITDs. In particular progress reports should contain progress achieved against progress planned and achieved deliverables against planned deliverables. The Panel recommends technical evaluation reports to follow the EC standard. This standard is useful in terms of evaluating in a systematic manner technical and management aspects. || JU

Efficiency of communication ||

Cooperation and exchange between ITDs appears to be limited still and should be enhanced. Models and tools produced across ITDs should be analysed in view of potential complementarities. The TE interface with other ITDs deserves careful consideration to ensure timely results. || GB, JU

CS1 and CS2 related: The Panel believes that communication between ITDs can be improved by using to a larger extent the TE as a tool to feed back information and to discuss efficiency in technical matters. A closer relationship with the working groups of ACARE and SESAR could also improve this communication process. The JU team should be more involved in this process and additional resources need to be allocated to this task. || GB, JU, EC, Future PPPs

The Panel believes that raising the profile of Clean Sky should be a key aspect of the CS Communication objectives. The Panel endorses the recommendations of the previous interim evaluation and reiterates that CS should improve its visibility amongst the interested public. || JU

The Panel appreciates the effort on the part of the Executive Office to communicate call topics and disseminate the Clean Sky initiatives via publications. However the Panel felt that, as there have been more success stories coming out of the projects, these could form the basis for intensified dissemination targeted to a broader range of stakeholders, including policymakers within the Member States. || JU

The technical information on the website should be improved with a more active involvement and input from the ITDs. Moreover it is deemed necessary to find appropriate forms to communicate the activities and assessment of the TE. || JU

The Panel recommends that the CS communication strategy puts more dedicated efforts for communicating the broader socio-economic and environmental impacts not only to the aeronautical stakeholders, but also to the policy and decision makers at the European and national levels. The NSRG and STAB should be involved in these initiatives. || GB, JU

The Panel commends that Clean Sky has been successful in attracting a high level of interest from companies, well above the average participation of industrial entities in collaborative projects in FP7. However the Panel notes that although there is a remarkably high participation of SMEs, Clean Sky is still perceived as “big industry and big technology” and therefore recommends that success stories involving SMEs are communicated on the website and in dedicated publications. || JU

Quality of Activities ||

The Panel recognises the added value of technical visits and technical presentation meetings which provide more insight and permit a deeper analysis in favour of an objective assessment. The Panel considers this a key instrument to assess the quality of the technical developments and recommends to make site visits an integral part of the review process || JU

Quality of Calls for Proposals ||

In case of a large number of proposals for a specific ITD, the Panel recommends a flexible distribution of responsibilities in order to optimise the associated workload within the JU. || GB, JU, Future PPPs

It is proposed that the topics include the possibility to present a more innovative approach leading to the same results than the one described in the topic. || JU, Future PPPs

It is recommended that the technical ITDs reviews include a systematic CfP review to monitor and contribute to the high quality of the CfPs. This would establish a clear connection between CfP topic and ITD objectives, thus improving the focusing of the technical activities. || JU, EC, Future PPPs

The Panel notes that, in some cases, the inappropriate choice of subcontractors has led to poor results relative to the project they are related to. The Panel therefore recommends the JU to investigate possible ways of improving the selection process of subcontractors. || JU, Future PPPs

Smart Fixed Wing Aircraft (SFWA) ||

The Panel recommends that flight tests should be taken into account at the very beginning of the ITD. It is to be recognised as a necessary step, overlooked at the project launch but very much needed to ensure project success. || JU

For large ITDs, it is recommended to adopt systematically an industrial project management methodology from the very beginning of the project. || JU

It is recommended to secure robust commitment from the participants, to find ways to prevent a lack of interest and of focus from the participating companies and to secure adequate resource allocation by all. || JU

The Panel recommends the JU to focus on minimising the risk of insufficient commitment of resources, and to entrust the GB with the responsibility of motivating the potentially defaulting partners. || JU

Downstream research leading technologies to TRL6 maturity should achieve the following steps: performance readiness, engineering readiness, operational readiness (main tenability, stability, etc …), manufacturing readiness. The Panel believes this recommendation is applicable to all large ITDs. || JU, Future PPPs

Green Rotor-Craft (GRC) ||

The Panel encourages the Partners and Project Managers to provide more clarity and consistency in the figures presented as well as on the assumptions taken for the evaluation of the environmental targets in relation with the ACARE goals. || JU

Systems for Green Operation (SGO) ||

The Panel recommends carefully monitoring and implementing an early warning mechanism for critical activities, success factors of SGO. || JU

SGO benefits are expressed per flight phase. This makes a comparison across ITDs difficult regarding the most promising technologies. Therefore, the Panel agrees with technical reviews about alignment of SGO environmental benefits metrics to other ITDs. || JU, Future PPPs

Demonstration activities for some equipment are foreseen in a single test platform. Back-up plans in case of delays in the test platform need to be addressed. || JU, Future PPPs

Sustainable And Green Engines (SAGE) ||

It is strongly recommended to explore the possibilities of testing the gearbox (with AVIO) in order to reduce the associated risk. || JU

The conditions of access to the future Gearbox test rig by third parties needs to be clarified. || JU

The planning and technology features of the SAGE 4 demonstrator need to be clarified and confirmed. || JU

Any proposal for a lean burn flight test within Clean Sky time scale should be clarified in terms of schedule and financing. || JU

Eco-Design (ED) ||

It is recommended to check that EDA is taking into account lessons learnt by other domains, such as automotive, and by the emerging deconstruction eco-system. || JU

Taking into account the content of EDS, it is recommended to ensure consistency and check gaps or overlaps with SGO and GRA/ GRC ITDs related to electricity. There are synergies and potential cross fertilization opportunities. || JU

Technology Evaluator (TE) ||

The Panel has not identified clear quantifiable targets for Life Cycle Assessment (LCA). It is recommended that methods and metrics to assess LCA benefits are addressed by CS present and/or future research. || JU

The resolution, granularity and assumptions included in the aircraft models have a potential impact on the verification of their representativeness and accuracy. The Panel recommends that aircraft models are as transparent as possible in relation to to known standards . || JU, Future PPPs

The duration of the TE information system needs to be aligned to the duration of TE assessments. This is to record latest assessment results and their impact. || JU, Future PPPs

Low TRL technologies are included in aircraft models. However, the purpose of the TE is to assess the impact of mature and most promising technologies and a better focusing of TE goals should be established. || JU, Future PPPs

General Issues ||

Clean Sky has a lot of ground and flight demonstrations at programme end. Significant attention should be paid towards the most critical and success factors of the programme. Careful monitoring and prioritisation of available resources vs. remaining work and vs. technology environmental benefit towards demonstration is recommended. || JU, Future PPPs

The main objective of CS is to accelerate the introduction and development of environmental friendly technologies in the next generation vehicles. While it is important to review overall management documentation and progress of technical activities, it is particularly crucial to perform a verification of actual developments at Partners sites. The Panel recommends future evaluations to include technical site visits. A representative selection of technical visits provides new ways of understanding developments and to reconcile technical evidence and lessons learnt across ITDs. ||

Management 2010-2013 evolution ||

The Panel recommends the streamlined coverage of CfP towards ITDs objectives and endorses the overall regular review of the CfP programme within the CS prioritising at this stage demonstration activities. || JU, EC, Future PPPs

The Panel is concerned that many demonstration activities have been shifted towards the end of Clean Sky and recommends ensuring the adequate deployment of resources within the ITDs. || JU

Scientific and technical comparison ||

The Panel recommends to freeze the objectives and plans as soon as possible and to monitor closely the technical status of SFWA projects in order to make sure that no further delays occur. The ITD has probably overcome the most important risks, some exist still. || JU, Future PPPs

With the aim of minimising the danger of planned demonstration programmes failing to be achieved within the timeframe of Clean Sky 1, continued efforts should be made by project managers to emphasise to their higher management the - technical, commercial and political- importance of the Clean Sky Joint Undertaking, and ensure the appropriate level of resources are available and committed to the projects. || JU, Future PPPs

The Clean Sky Project Manager should keep under review the emerging results and potential application of CfP topics, with a view to identifying increased opportunities across the whole of CS. || JU

Further consideration should be given to estimating the benefits of the Clean Sky programme with regard to contributions from other relevant programmes, and to how the benefits can be shared with stakeholders outside the specialist scientific/technical community. || JU, EC, Future PPPs

The Panel is of the opinion that when the SFWA/AI go/no-go decision on a CROR demonstrator aircraft emerges it might be necessary to reconsider and clarify SAGE 1 future activities within the Clean Sky timeframe. || JU

FCH

Recommendation || Responsibility

Programme governance, design and management ||

Governance of the programme needs to ensure: that decision-making is more prompt; that more resources are assigned to programme and knowledge management and that the private sector's commitment continues to be comparable to the EU's effort. The Executive Director should have greater executive authority; administrative functions should be shared with other JUs and/or taken back into the Commission services; the Commission should agree a mechanism to demonstrate that the industry adopts “stretch” targets for its own research and early deployment expenditure. Contractual targets to steadily reduce time-to-grant should be introduced under Horizon 2020. || EC, GB

The research strategy for the continuation of the FCH JU in Horizon 2020 should focus more sharply on three main principles: alignment with EU policies; areas where Europe has or can achieve leadership; adaptation to changing needs of the sector. || GB, Advisory bodies

Storage and cost-efficient end-use of electricity together with the production of hydrogen from renewable sources should be priorities of the energy pillar; additional actors (e.g. network operators) will need to be recruited. Synergies and interaction with other programmes along the whole value chain should be maximised (e.g. “Advanced Materials” and with “Advanced Manufacturing and Processing”), Green Vehicle, SET-Plan EIIs (e.g. Smart Grids). Six to ten per cent of the FCH JU budget should be reserved for breakthrough oriented research. || GB, PO

The capacity to adapt to change should be strengthened. Programme results should be fed back more effectively into the AIP and MAIP.Whilst preserving stakeholders' confidence in the long-term vision; a closer integration of industrial interests with those of other stakeholders should be sought through joint workshops with the research community, advisory bodies and representative regional organisations. || PO, IG

Certain research areas need greater prominence: the FCH JU should develop a strategy for Regulations, Codes and Standards including international dimension across the FCH businesses that is agreed by all (IG, RG, SRG, Commission) and that draws upon the resources of the JRC. || PO, GB

SME participation should be further strengthened through a scheme of financial guarantees as in the Framework Programme and linkage between research projects and venture capital funding from the RSFF to generate new and innovative European companies and businesses. || EC

Technology Monitoring and Policy Support ||

The JU should implement a robust technology monitoring procedure adapted to project, programme and policy levels. Results should be used to adapt the research programmes and made available to the SET Plan and for policy support. || PO

Much greater disclosure and dissemination of results is essential. Future proposals should be obliged to include a list of publishable KPIs and evaluation should penalise low levels of disclosure. Existing projects should be encouraged to disclose post hoc some of their results. The FCH JU should introduce “clean rooms” for this purpose. || PO

Policy DGs within the Commission need to provide greater clarity and visibility of public policy for FCH related activities (e.g. zero emission vehicles, energy storage). The procedures for incorporating scientific evidence into transport and energy policy should be transparent and effective and be consistent across the sectors. || EC, PO

Engagement with Member States and Regions ||

Member States involvement in the programme must be strengthened. The mandate of the SRG should be upgraded to cover strategic functions including a proactive role in the choice and design of large-scale demonstration and deployment projects and participation in technology monitoring; the flow of information between the SRG and the Programme Office needs to be improved; members should be more clearly associated with national research and/or industrial policies; innovative solutions for co-funding by Member States should be explored (e.g. ERA-NET activities or conditional co-funding within Calls). || EC, GB, SRG, PO

The relationship with regional and local authorities is critical to deployment. The relationship with organisations such as HyER is important for transport and should be better exploited. Similar relationships must be built for storage and other aspects of infrastructure. || PO

Finance of future deployment and build-up capacity projects is vital and will require new financial arrangements. The Commission should investigate whether Hydrogen infrastructure can be made eligible for funding within the new National Strategic Reference Frameworks for Structural Funds. The FCH JU should be prepared to facilitate developers by providing advice on available financial options from EU institutions, including the EIB, Structural Funds and TEN-T loans and grants; calls for preparation of fundable projects should also be considered. || EC, Member States, PO, GB

Communication and dissemination ||

The FCH JU should strive to be the most authoritative source of knowledge in Europe for FCH. The visibility of the FCH JU should be greatly improved and the website needs to evolve to reflect this ambition. The rules governing the provision of information about the programme to various stakeholders (Scientific Committee, SRG, Commission services) should be reviewed to determine whether the JU can disseminate more within a proper interpretation of those rules. If this is not possible then the rules should be modified appropriately for H2020. || PO

The FCH JU should support the engagement, education and training of stakeholders beyond the immediate FCH Community and should engage the SRG in this process. || PO, GB

IMI

Recommendation || Responsibility

Communication Strategy ||

IMI needs to finalize and implement an articulated communication strategy with clear and measurable goals and objectives, addressing both the key stakeholders and a wider audience. || GB, JU

Stakeholders relations and KPI-s ||

Alongside the existing KPIs, aggregated KPIs need to be developed and measured in order to quantitatively demonstrate the IMI impacts and socioeconomic benefits. || EO, JU

IMI should make an additional effort to increase engagement from a wider range of industry stakeholders. || EO, JU

Industrial participants from other healthcare related sectors should be involved in IMI2. || GB, SRG, JU

Organisation and efficiency ||

The IMI Executive Office should seek further ways of reducing bureaucracy and ensure that it has the optimal organizational structure for the tasks ahead. || EO, JU

IMI should seek to maximize the potential of its advisory bodies to gain support for the remaining calls and other activities at all levels. || EO, JU

IMI needs to plan for and design new and more flexible funding mechanisms to ensure the sustainability of current and future projects, where appropriate. || EO, JU

The Commission should ensure that IMI2 is transparent and has increased flexibility in terms of governance. || GB, EC, JU

Data availability ||

Baseline data should be obtained in parallel with the launch of IMI2 in order to allow for better benchmarking and assessment of IMI2 performance. || JU

ANNEX II: SWOT Analyses

CS

STRENGTHS · The basic principle of PPP in aeronautic research has been successfully demonstrated. CS JU is a central element of the European aeronautics landscape and is recognised as a world-leading PPP in aeronautics · Distinctive cooperation model to address non-competitive aeronautical challenges · Builds on FP6 and FP7 results, catalyst for private sector investment in European aeronautic R&D · Valuable contribution to ACARE objectives. The TE represents an innovative approach to evaluate environmental benefits in a systematic way. The TRL evaluation could be adopted in other areas in the H2020 programme. · CS JU as a valid instrument to achieve agreement on a strategic research agenda and (potentially) efficient use of research budget · High quality of scientific output and wide network of industry, SMEs and academia · High SMEs participation and involvement. Remarkable mobilisation and pooling of resources and expertise to tackle the most complex problems of aeronautics along the entire R&D cycle · Mobilised resources reinforced by synergies across a broad range of stakeholders · Effective governance structure and proactive participation of advisory bodies (NSRG and STAB) · High quality of processes and methodology · Gaining visibility through dissemination of results in scientific papers and conferences, air shows and exhibitions || WEAKNESSES · KPIs and Technology Evaluator not mature enough to demonstrate broader environmental and socio-economic impact · Inadequate balance between scientific and administrative tasks of the CS Executive Office: -burdensome administrative rules, regulations and controls and -insufficient technical resources (JU level) to tackle transversal issues · Low flexibility esp. by budgetary issues; lack of a contingency budget · In some ITDs unmet quality and effectiveness · No active use of TE feedback by ITDs · Insufficient resource allocation from companies in some ITDs · Lack of clear priorities in allocating resources to projects in some ITDs · Still insufficient communication between ITDs · Limited coordination with national/ international initiatives potentially leading to inefficient use of resources

OPPORTUNITIES · Potential for CS as a platform for building a common European vision for environmental focused research in Aeronautics · Developing new funding models · Communicate the broader socio-economic and environmental impact beyond the aeronautic stakeholders · Explore synergies and potential cross-fertilisation in other industry sectors · Building a favourable environment for Level 2 like projects in the Framework of next EU Research Programme || THREATS · A negative perception among key stakeholder groups · Lack of priority in allocating key resources by key players (associates) triggering endless issues: de-scoping, rescheduling... · Missing key changes in aeronautic market needs · Changes in European industry structure, i.e. new ownerships or joint ventures

FCH

STRENGTHS · The basic principle of PPP in FCH research has been successfully demonstrated · The FCH JU is established as a central element of the European FCH landscape · FCH JU has proved a valid instrument to achieve agreement on a strategic research agenda and potentially efficient use of research budget · Strong communities within the IG and RG have been created · Ensuring a steady industry-led development towards longer-term targets through varying economic cycles · Impressive mobilisation and pooling of resources and expertise · Critical mass reached for the automotive application area · Stable budget for long term development attracting private sector · Strong stakeholder participation, especially industry involvement and RG cooperation · Governance is in place and working · Project management is perceived positively by projects coordinators || WEAKNESSES · Burdensome administrative rules, regulations and controls · Sub- optimal use of resources and inappropriate balance of scientific and administrative staff · Project funding rates inferior to FP rates and unpredictable · Lack of a guarantee fund to cover for SMEs in a weak financial position · No coherent approach to stationary applications and early markets · Lack of coordination with national programmes; uneven MS involvement and commitment to the FCH JU · Insufficient adaptability to realign obsolete targets · Little exchange between the FCH JU and the FP basic research programme · Insufficient targeted communication and dissemination strategies and efforts and low visibility · Insufficient monitoring and knowledge management at project, programme and policy levels · The work on cross-cutting activities has not progressed well

OPPORTUNITIES · Contribute to EU societal challenges identified in the energy, transport and climate change policies · Create European lead in emerging field of high potential · Create real alignment between regional, national and European initiatives · Increase visibility triggering new entries and political support · Promote best practices and enhance awareness of the technology for the public and policy makers across Europe · Common vision building and communication to participants and beneficiaries · Stimulate coordinated large scale deployment and capacity building of FCH technology · Limitations of BEV might shift industry and political interest to FCEV · Integration of large amounts of renewable electricity by using hydrogen as an energy storage medium · Interaction with other industries can generate new opening for businesses incl. SMEs · Synergies and interaction with other programmes along the whole value chain || THREATS · Low energy prices and inadequate policy measures · Shifting emphasis on EU climate, energy and competitiveness policy objectives · Failure to attract necessary investments for the supplier and infrastructure industry · Unsolved technical obstacles, especially for performance and cost · Lack of EU competitiveness or lagging behind compared to Asia and North America in the near future · Lack of openness of export markets (e.g. Asia) · Failure to put in place the relevant incentives for market uptake · Lack of political/policy support for FCH · Low public acceptance by end-users due to incapability to communicate benefits to society and/or accidents · Prolonged economic/financial downturn may cause loss of interest of the public and/or private sectors · Breakthrough of competing technologies · Uncoordinated and isolated demonstrations at EU, MS and regional levels without consideration for product development, marketability and capacity build up in a commercial product.

IMI

STRENGTHS · Recognized as a world-leading PPP in healthcare, particularly in the US · Unique collaboration model to address non-competitive unmet medical needs (addressing market failure) · A catalyst for private sector investment in European biopharmaceutical R&D · High quality of scientific output and vibrant networks of academia, SMEs and industry · Increased the level of trust among many relevant stakeholder groups including regulators · A critical mass of expertise to tackle the most complex problems of healthcare needs along the entire R&D cycle · Mobilised resources reinforced by synergies across a broad range of stakeholders · Industry led initiative with strong support from the CEOs of EFPIA companies and a focus on tangible outcomes || WEAKNESSES · Lack of clear, targeted communication strategy; low visibility · KPIs not mature enough to demonstrate broader socio-economic impact · Insufficient incentives for SMEs and non-EFPIA members participation · Processes and regulations still too bureaucratic; · Advisory bodies not functioning to their full potential; · Lack of buy-in by MS leading to lack of alignment with MS policies and strategies; · Inadequate balance between scientific and administrative tasks in the IMI Executive Office, suggesting a need for new skills · Not all EFPIA companies involved · Lack of planning for project sustainability

OPPORTUNITIES · Increasing focus on meeting health challenges of the ageing population with high socio-economic impact · Building on, and learning from IMI as a proven model to catalyse stakeholder engagement e.g. patients, regulators · Maximising potential for IMI as a platform for building a common vision e.g. for health policy · Increasing scope and attracting non-EU investment for biomedical R&D · Leveraging other potential funding options e.g. via venture capital and/or EIB loans · Further improvement of the biopharmaceutical R&D environment via removing bottlenecks or improving processes e.g. for clinical trials · Exploring potential to involve other sectors and stakeholders e.g. payers, HTAs · Developing new funding models to explore results and increase sustainability || THREATS · Decrease of political support for IMI · Disrupted balance between pre-competitive and competitive boundaries · Lack of coordination with national initiatives leading to inefficient use of resources · Competition from other PPPs worldwide leading to decrease of interest by companies · Growing regulatory burden and tightening of pricing and reimbursement schemes · Loss of key personnel from IMI · Economic slowdown leading to lack of funding · A negative perception among key stakeholder groups (patients, payers, regulators) · Losing the competitive advantage to new emerging economies (i.e. China, Brazil) · Deteriorating reputation and diminished support in the EU as a result of non-performance · Decrease of political support for IMI

ANNEX III: Composition of the Expert Evaluation Panels

Expert Evaluation Panel Members || JTI JU

QUENTIN, Francois (Chair) (FR), Chairman of the Board of Directors of HUAWEI France and member of the HUAWEI Group Advisory Council, member of an Advisory Group to the Prime Minister Office; || CS

BROUCKAERT, Jean Francois (Rapporteur) (BE), Associate Professor in the Turbo-machinery and Propulsion Department at the von Karman Institute for Fluid Dynamics (VKI), Belgium; || CS

Ivonne HERRERA (NO), Senior Scientist at SINTEF ICT, Department of Software Engineering Safety and Security with more than 20 years of experience in the industry regarding avionics engineering, maintenance, air traffic management and safety analyses for aviation and oil and gas industries; member of the first interim assessment Panel in 2010; || CS

Enzo BERTOLINI (IT), Director of the 'Foundation Clément Fillietroz', operating the Astronomic Observatory and the Planetarium of the Aosta Valley (research in astrophysics and science communication for students and general public); member of the first interim assessment Panel in 2010; || CS

Anneli Ojapalo (Chair) (FI), CEO of Ojapalo Consulting Oy company and programme coordinator of the Finnish Fuel Cell Programme 2007-2013; || FCH

Nigel Lucas (Rapporteur) (UK), independent consultant with more than 30 years' experience in the energy sector; formerly Executive Director of Environmental Resources Management, and professor at Imperial College Centre for Environmental Technology; || FCH

Helge Holm-Larsen (DK), currently CEO of the SME TEGnology, formerly Director at Topsoe Fuel Cell A/S; || FCH

Dirk De Keukeleere (BE), independent consultant in the field of transport and energy technology, formerly researcher/manager in the Flemish Institute for Technological Research in the areas of fuel cell, automotive and energy. || FCH

Jackie Hunter (Chair) (UK) CEO of OI Pharma Partners Ltd. Her company has helped companies and organisations develop open innovation strategies and support their implementation, especially in life sciences R&D. Previously Jackie was a Senior Vice President at GlaxoSmithKline and chair of the Research Directors Group at EFPIA. At GSK her business unit delivered 17 clinical proof of concept. She has been part of international committees and policy groups on pharmaceutical R&D. As a nonexecutive director of a public company and a trustee/governor for academic and other organisations she has gained a broad perspective across many stakeholder groups. || IMI

Marcin Szumowski (Rapporteur) (PL), President & CEO, OncoArendi Therapeutics, founder, BTM Mazovia. Following a successful research career in the United States, Marcin Szumowski has been involved in technology transfer and start-up companies since 2000 and has co-founded and managed three start-ups, including now publicly traded Medicalgorithmics S.A. (), where he was President and CEO 2005-2010. Since 2001 he has been head of international relations and project management office at the Nencki Institute of Experimental Biology. He has been a member of the Independent Expert Panel assisting the European Commission with the Impact Assessment of European of the IMI2. || IMI

Tom Andersen (DK) is Head of the European Investment Bank’s Regional Office for the Near East in Cairo and independent consultant. Until a year ago, he was Deputy Economic Advisor at the European Investment Bank specialised in assessing economic viability of R&D projects and project finance operations in the pharmaceutical and chemical sectors. Previously, he worked on acquisition and divestitures within an industrial conglomerate and for Novo Nordisk, an EU-based pharmaceutical company, evaluating and reporting on developments of its drug discovery and corporate development arm. He has been a member of the First IMI JU Evaluation Independent Expert Panel. || IMI

Bart Wijnberg (NL) - before his retirement Bart Wijnberg worked for the Dutch Ministry of Health, Welfare and Sport where he held responsibilities for the commissioning of the seminal WHO Report Priority Medicines for Europe and the World in view of FP7, and for the launching of the Dutch Public Private Partnership Top Institute Pharma (TI Pharma). He was a member of the "Member States, Candidate and Associated Countries Contact Group for IMI" and of the First IMI JU Evaluation Independent Expert Group. || IMI

Maria Rosaria Di Nucci (IT) is Senior Researcher at the Environmental Policy Research Centre of the Freie Universität Berlin and independent consultant. She has been working in environmental and energy policy and policy assessment for over 25 years and participated in various EU Initiatives. A further focus of her activities is impact assessment. Dr. Di Nucci is an expert evaluator for European RTD funding organisations and the EC. She participates also in the evaluation of the Clean Sky JU and Fuel Cell and Hydrogen Joint Undertaking, acting as the common expert. || CS. FCH. IMI