Public Private PartnershiPs - Strenghtening innovation and reSearch in europe - December 2017 - n 49 - ecsel ju
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CARRYING THE TORCH FOR MEDICAL INNOVATION Find out more about IMI Visit our website: www.imi.europa.eu Follow us on Twitter: @IMI_JU #carrythetorch
J T I s S e c t o r s : N e w A m b iti o n s – N e w S c a l e | The European Files | 3 E D I T O R I A L PUBLIC PRIVATE PARTNERSHIPS STRENGHTENING INNOVATION AND RESEARCH IN EUROPE T T he European Union is halfway through the Horizon 2020 (H2020) framework for innovation and the journey so far is ripe for evaluation. H2020 is unique as a Framework Program for research and devel- at a continental scale. This is because the subjects of these ETPs and their objectives are both too large in impact and necessarily unachievable through national initiatives. Having identified key research themes such as and Transport, Clean Energy and--perhaps a testament to its importance in European society-- the two separate initiatives on Infor- mation and Communications Technologies lend themselves well to the management of opment due to its sheer scale in budget and Health or Transport research, the JTIs enable research programs in an “integrated manner”. duration. With lifespan of 7 years and an initial large-scale programs to extend the reach of As the evaluation of H2020 thus far reveals total budget of EUR 77 billion, it encourages H2020’s impact potential. For example, the certain gaps in its implementation, it is members of public research institutions, Innovative Medicines Initiative was created possible the European Union already pos- private organizations, and interested parties to tackle “bottlenecks currently limiting sesses working solutions within the breadth of at large to come together over strategic tech- the efficiency, effectiveness and quality of financing or organizing programs such as JTIs nological sectors. It does this by boasting one the drug development activities needed to and the accompanying Joint Undertakings. of the most sophisticated and comprehensive bring innovative medicines to the market”. This issue of the European Files… funding portfolio enabling a variety of actors Europe’s ability to unite all stakeholders to find funding for their projects, big or small. involved in the financing, development, LAURENT ULMANN With the noble ambition of organizing research approval, and marketing of new medicines that will contribute to “building a society and is crucial to maintaining a competitive phar- economy based on knowledge and innovation maceutical industry to properly address across the Union”, H2020 stands out as itself a the Union and its citizens’ needs. Programs pioneering program for innovation. funded under JTIs each benefit from unique approaches to research and development, It is clear that part of its strength as an including measures of “open innovation” institutional tool for innovation stems from enabling cross-company collaboration and its versatile financing packages to projects asset sharing. of all sizes. H2020 includes a set of strategic research sectors and promises to review each In fact, H2020 wholly deserves the attention bid based on potential impact. Although the of the interim evaluation to review and revise effectiveness of this approach cannot be fully its capacity to maintain a high level of efficacy evaluated at this time, several ambitious ini- in delivering innovation to Europe’s citizens. tiatives have been launched, refinanced, and Doubly important is the public’s awareness improved to meet a standard of excellence. and perception of these innovation initiatives. One of the most exciting approaches to Whereas some projects may be so focused research that has experienced new life under as to invite very specialized interest groups, H2020 is the Joint Technology Initiative (JTIs). the JTIs offer an innovation scope relevant to Although some research sectors may benefit several Member States and its citizens. Key from a highly focused scope, several Strategic technological advances must have the capacity Research Agendas require coordination and to open and drive new markets. The break- leadership in European Technology Platforms throughs required in sectors as large as Health Management: The European Files / Les Dossiers Européens - 19 rue Lincoln, 1180 Brussels www.europeanfiles.eu - ISSN 1636-6085 - email: ulmann@europeanfiles.eu - Publication Director and Editor-in-Chief: Laurent ULMANN - Intern: Raphaël Benros Layout & printing: VAN RUYS PRINTING Copyright: Shutterstock
4 | T h e E u r o p e a n F i l e s | J T I s S e c t o r s : N e w A m b iti o n s – N e w S c a l e TABLE OF CONTENTS PPP’s for a long-term vision for The Innovative Medicines Initiative: taking open competitiveness in Europe 6 innovation to the next level 14 Jyrki Katainen, Vice-President and Commissioner Jobs, Pierre Meulien, Executive Director, Growth, Investment and Competitiveness, European Innovative Medicines Initiative Commission The Innovative Medicines Initiative: Horizon 2020 Review: Towards a more coherent Carrying the torch of medical innovation 16 R&I funding landscape 7 Magda Chlebus, Executive Director, Science Policy & Mailis Reps, Estonian Minister of Education and Research Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations (EFPIA) Streamlining European Research Initiatives 8 Frédérique Vidal, French Minister of Higher Education, Value of Private Public Partnerships to Research, and Innovation address Infectious Disease Risks and needs for epidemic prevention 18 Pushing a long-term vision for PPPs 9 Jean Lang, MD, PhD, Associate Vice President R&D, Global Health, Partnerships & Funding, Sanofi Pasteur Jarosław Gowin, Polish Minister of Science and Higher Education Corinne Bardone, Pharm D, Head of Global Vaccines Public Affairs for Polio, Pertussis and Hib Vaccines, Sanofi Pasteur Preparing for FP9: Reinforcing JTIs and their potential 10 Jörg Leichtfried, Federal Minister for Transport, Innovation and Technology of the Republic of Austria Energy sector PPP initiatives in the context of the European Energy Regional Impact of Joint Technology Initiates and Union - A powerful element for a sustainable energy Public-Private Partnerships for European system 20 Competitiveness and Innovation 11 Paul Rübig, MEP (EPP Group), Member of the ITRE Markku Markkula, The First Vice-President of the European Committee Committee of the Regions (CoR) and City councillor of Espoo Joint Undertakings: an efficient tool toward the energy transition 21 JTIs Sectors: New Ambitions – New Scale Dominique Ristori, Director-General, DG Energy, European Commission Health sector Advantages of a JU for a Clean Energy future 22 IMI contributes to efforts to accelerate access to Bart Biebuyck, Executive Director of FCH2 affordable, innovative medicine 12 Miroslav Poche, Miroslav Poche, MEP (S&D Group), Bio-Economy sector Member of the ITRE Committee To boost and facilitate the process of dispersion of PPPs: The Patients’ View 13 new technologies the role of SME’s is crucial through Nicola Bedlington, EPF Secretary General the PPP 24 Andor DELI, MEP (EPP Group), Member of the TRAN Committee
J T I s S e c t o r s : N e w A m b iti o n s – N e w S c a l e | The European Files | 5 The necessity to sustainable bio-based economy Transport in the EU 25 Franc Bogovič, MEP (EPP Group), Member of the REGI The future of Joint Technology Initiatives in Committee the field of digital transport 36 Henrik Hololei, Director-General for Mobility and Transport, Strengthening European bio-based industries in a European Commission. competitive global market 26 Philippe Mengal, Executive Director of Bio-based Industries Aviation Strategy for Europe, the importance of JTIs 37 Joint Undertaking (BBI JU) Pavel Telička, MEP, Vice-President of the European Parliament Committee for Transport and Tourism Group of Taking stock of Europe’s bio-based industries: the Alliance of Liberals and Democrats for Europe new sectors, new value chains, new investments 28 Dirk Carrez, Executive Director, Bio-based Industries Upgrading Europe’s skies, digitally 38 Consortium Florian Guillermet, Executive Director, SESAR Joint Undertaking Investment framework to build a competitive, dynamic and sustainable bioeconomy in Europe 30 Clean Sky: Innovative results for a more Miapetra Kumpula-Natri, MEP (S&D Group), Chair of the competitive Europe 40 Bioeconomy Working Group, EP Intergroup “Climate Change, Tiit Jürimäe, Interim Executive Director, Clean Sky 2 Joint Biodiversity, and Sustainable Development”, Member of the Undertaking ITRE Committee Shift2Rail: no train, no gain 42 Dominique Riquet, MEP (ALDE Group), Vice-Chair of the Digital sector TRAN Committee Public-Private-Partnerships in Horizon 2020 and beyond 31 JTIs in Rail: Tackling a European transport Roberto Viola, Director General DG CNECT, challenge with a new comprehensive approach 44 European Commission Carlo Borghini, Executive Director of Shift2Rail ECSEL Joint Undertaking: shaping digital innovation 32 Energy efficiency in the field of transport, Bert de Colvenaer, Executive Director of the ECSEL JU a societal requirement 46 Gesine Meissner, MEP (ALDE Group), Member of the TRAN Committee Joint Technology Initiatives and Joint Undertakings: speeding up Europe 34 Lambert van Nistelrooij, MEP (EPP Group), Member of REGI Committee Stimulating the innovation through of the PPP’s 35 Marian-Jean Marinescu, MEP (EPP Group), Member of the TRAN Committee
6 | T h e E u r o p e a n F i l e s | S t r e n g h t e nin g I nn o v ati o n an d Research in e u r o p e PPP’s for a long-term vision for competitiveness in Europe One of the most useful instruments to research to the marketplace. For Europe this overcome market failures is organised part- means a stronger bio-based industrial sector, nerships between the public and the private which can make it possible to reduce our sector. It can encourage more breakthroughs dependency on fossil based products, fight and ensure that great ideas are carried from climate change and lead to greener and more the lab to the industry. We must make environmentally friendly growth. Overall, PPPs the most of the knowledge and science we can also boost sustainable development in produce to enhance growth, productivity and Europe. competitiveness in the long- run. The world is changing faster than ever. New EU relies on Public-Private Partnerships technologies are introduced all the time and (PPPs) when operating under the Horizon Europe must be ready – not just to respond 2020. This is so far the biggest EU Research and adjust – but also to invent and lead in the Jyrki KATAINEN and Innovation programme, with nearly adoption of new technologies. Vice-President and Commissioner Jobs, EUR 80 billion of funding made available over Growth, Investment and Competitiveness, 7 years (2014 to 2020) - and in addition to this Our digital economy must have trustworthy European Commission comes the private investment that this money ICT products, services and software in order attracts. to develop. It is vital to secure Europe from cyber-threats and make us more resilient to When teaming up with the industrial cyber-attacks. That is why EU is engaged in Q uality research and innovation is very sector, the implementation of research and another important PPP to support innova- important for advanced economies innovation activities further improves. Mobi- tive solutions in the field of cyber- security, like Europe’s. The value of Europe’s lising joint investments supports the competi- which is expected to trig- ger €1.8 billion of future relies upon our ability to produce tiveness of sectors that can develop closer syn- investment by 2020. knowledge and how well we succeed in trans- ergies with national and regional programmes, forming this knowledge into innovation and and encourage greater private investment. Looking at the future, we now need to growth. strengthen further the results achieved under A concrete example of an EU PPP is the the current research programme. The evalua- Research and innovation are also crucial, Horizon 2020 Bio-Based Industries Joint Under- tion we carried out highlighted its strengths if we want to create a sustainable economy, taking (BBI JU). A EUR 3.7 billion investment in as well as the areas for development. Horizon high quality jobs and strengthen the competi- bio-based innovation - with EUR 975 million 2020 has proven to be a successful pro- tiveness of European industry. of EU funds and EUR 2.7 billion of private gramme to stimulate research and innovation investments. benefitting Europe’s competitiveness. The next Research and innovation are often high risk programme will learn from the experience and activities without guarantee for success or Here the partnerships ensure industrial will aim to deliver even greater benefits for the profits. Many private investors are therefore research and help narrowing the gap from competitiveness and growth of Europe. reluctant to invest even though the economic or social return could potentially be large. This unwillingness to invest dampens Europe’s innovation potential. Moreover, while on fundamental research Europe enjoys a leadership position in the world, on market-creating innovation the challenge is still ahead of us. The European Commission is committed to take a leading role to support research and innovation. Because of the nature of research, the significant economies of scale and the importance of cross-border cooperation, this is one of those areas in which the European Union can have a real added value.
S t r e n g h t e nin g I nn o v ati o n an d Research in e u r o p e | The European Files | 7 Horizon 2020 Review: Towards a more coherent R&I funding landscape of PPPs1 in Europe – under each one there are do not know what new partnerships are in the in turn a large number thematic initiatives. pipeline. This is a problem for many Member From the Horizon 2020 we co-fund altogether States, but especially for EU-13 countries. Early ten contractual Public-Private Partnerships access to the discussions on the identification (cPPP), seven Joint Technology Initiatives of topics and activities to implement these is a (JTIs) and six EIT Knowledge and Innovation starting point for creating more equal partici- Communities. Whilst there is no doubt that pation conditions. the individual partnership initiatives are doing a good job, the overall R&I funding landscape Vision in moving forward has become too complex, and therefore needs To realize the full potential of partnerships a more thorough discussion at the political for EU R&I policy, we need to have a clear level before moving into FP9. This is why we agenda at the EU level for defining, what topics decided to address this as one of our priorities we are going to push forward, and a common Mailis REPS during the Presidency of the EU Council. framework for all partnerships. In practice Estonian Minister of Education and Research this means having clear conditions when we When we first introduced this topic during implement certain topics via R&I partnerships, the informal meeting of research ministers in coupled with a strategic process for iden- Tallinn in July, I was positively surprised by tifying, implementing and phasing out all EU the support for this topic expressed by other R&I partnerships. countries and there was a general agreement S that we need to rationalize the current Coming back to the 3% R&I investments ince the launch of European Research complex landscape to ensure its coherence target and the current low share of private Area at the turn of the century, and accessibility to all parties involved. These investments in the Union, we also need to Framework Programmes (FP) have observations have also been confirmed by look at whether the current PPP implemen- developed instruments to incentivize the findings of the Horizon 2020 Interim Eval- tation modes deliver the expected leverage. European research and innovation (R&I) uation, as well as echoed in the Lamy Report First, there is the question of whether we partnerships to address the fragmentation of and the European Parliament report on the need so many different layers of PPPs and R&I efforts, better coordinate investments, assessment of Horizon 2020. whether they truly complement each other. priorities and programmes, and increase Secondly, we need to reflect on whether the investments in research. current PPPs in Europe have the means and Current challenges The development of different types of PPPs tools to be dynamic and bring about a truly In March 2002, the European Council transformative change in addressing particular is very important in the context of economy adopted the Barcelona objective to increase societal and economic challenges. and development of R&I policies. However, the the overall spending on research, development multiplication of instruments has led to a new and innovation in the Union with the aim of The preparation phase of FP9 is clearly type of fragmentation and a lack of overall approaching 3% of GDP by 2010, of which the time to address the complexity of EU coherence between the different instruments two-thirds should come from the private R&I partnership landscape. This is a time to and initiatives. sector. Although this goal was renewed in the rethink the EU approach to partnerships, and Europe 2020 strategy, the EU investments in not just make marginal changes. I invite all Although there have been efforts to clarify R&I have stayed at 2.03%. So let me start by stakeholders to actively contribute to the dis- criteria for selecting and implementing PPPs saying that reaching this target should be the cussions on how we can ensure alignment of in the Horizon 2020, these have not managed guide in everything we do. resources and activities in the EU, with the aim to reduce new partnership proposals or to jointly address common challenges, and expectations on what happens to the existing In this context, the EU public-private part- reduce the fragmentation of R&I efforts. Also, ones after FP co-funding ends. I think we have nerships (PPPs) form a very important part of I urge strong existing consortia to look outside reached a point where we have to reflect the EU policy, especially for mobilising private of their traditional partners and activities and critically on the share of funding we should sector investments and developing a long- keep their minds open to new and exciting allocate to partnerships as they already take term vision in addressing socio-economic R&I players. I know that Estonia has a lot to up 25% of the Horizon 2020 budget. If we do challenges. offer in research and innovation, and hopefully not deprioritize, there will be no room for we have given you a good ‘sneak peek’ during the emergence of new topics or networks. New types of public-private partnerships our Presidency. But more importantly, I am Moreover, it makes our national selection have been launched with each Framework happy about the warm response that we have processes extremely difficult because we often Programme that either benefit directly received from partners across all Europe to from the FP or at least exert influence on its this topic and I hope we have contributed to content. Currently we have six different forms 1 cPPPs, JTIs, EIT-KICs, ETIPs, ETPs, EIPs. creating a simpler and more open FP9.
8 | T h e E u r o p e a n F i l e s | S t r e n g h t e nin g I nn o v ati o n an d Research in e u r o p e Streamlining European Research Initiatives State of play and ideas for the time-consuming without real added- value for them nor for the industrial future sector as such. There is undoubtedly room European R&I partnerships are essential for simplification. I therefore suggest that tools for experimentation and structuration. a common reflection should be initiated In the last decade, a lot has been done to between the Commission, Member States stimulate the co-design and co-investment and industry in order to take into account of a wide range of European R&I, with the this diversity and differentiate mature Member States and the private sector. For and integrated European value-chains instance, on the co-designing side, since 2008, from more recent and unstructured ones 10 joint programming initiatives have enabled and define PPP key performing indicators the adoption of common agendas among the accordingly. member States. Similarly, the European Com- › › PPP interactions with the Member States mission has favored the involvement of the Frédérique VIDAL should be reinforced, as the latter rep- private sector in the design as well as in the resent more than 90% of the total R&I French Minister of Higher Education, project implementation of the private sector. public investment in Europe. This dialogue Research, and Innovation The principle of cPPP, for instance, has is of utmost importance to help Member brought a clearer, institutionalized and more States take the best advantage of the very transparent dialogue between the European high quality of the SRAs while helping the Commission and the stakeholders, in particular PPP stakeholders to propose a more lim- with specific industrial sectors. Moreover, ited number of focused EU-level relevant when properly managed, cPPPs have a great Why streamlining matters? EU added-value by pulling together Europe R&I priorities. In this respect, Member We live today in an exciting and unprec- States have to be closely involved in the academics and industries and encouraging governance of these partnerships. edented time: knowledge creation has never them to structure themselves, share their ›› A right balance has to be kept between been so strong, turning this new knowledge visions and cooperate on mid to long term the need to provide visibility to the in- into innovation has never been done so research and technology challenges. As an dustry and the capacity to adapt to new quickly, and the international competition has illustration, the reports (Strategic research and emerging areas or new industrial trends. never been so intense. As public policy makers, innovation agenda, (SRA)) produced by cPPP In other terms the budgetary commit- we have to make our Research & innovation associations are often of great quality and (R&I) policies as lean as possible. This is even ments in PPPs need to be used as flex- contribute to the efficiency of the European ible frameworks for the programming of truer for Europe. Commission programming. Indeed, R&I is key to the future of Europe. actions. With a view towards the FP9, these part- ›› Finally, finding the right balance between Investment in this sector relies on a wide nerships instruments must be further used representativeness and openness requires range of actors: Member States, European to serve strategic objectives codesigned by fine tuning. PPPs must not turn into close Commission, local governments, private Member States, the Commission and the clubs and be open to novel ideas and new sector. Yet, in spite of this undisputed political industry, such as technological autonomy. actors especially SME and start-ups. Yet, importance and of this significant number of Their input should go beyond mere calls for they must remain attractive to partici- funders the investments at EU level in R&I still projects. France deems necessary to strengthen pants. As such, PPPs may not be adapted lag well behind the political target coined as the support to public-private partnerships, to sector characterized by a high level part of the so called Lisbon strategy almost 20 namely JTIs, for industry sectors matching the integration and concentration, where the years ago and reaffirmed in the Europe 2020 maturity and excellence criterias. level of commitment by public authori- strategy: indeed, in 2015, the level of research A few tweaks are therefore necessary to ties must be enduring, and where a very and development in the EU28 lies at 2.03% of further improve PPPs impact: strong coordination between R&I activi- the GDP, a far cry from the 3%. ›› The wide range of maturity degrees across ties is required. For this latter initiatives, In this context, streamlining the landscape different industrial sectors has insuffi- very limited in number (such as European of the European research initiatives is needed, ciently been taken into consideration. As low-power processor for example), other not only to progress toward the achievement an example, one cannot ask the same level tools are required while keeping the nec- of the European Research Area, but also to of common commitment and assign sim- essary relationships with the parent PPPs. simplify the whole framework and make it ilar objectives to 5G and Big-Data indus- Based on three keywords (focus, simpli- more efficient. This is a key issue to facilitate a tries! Yet, too often, extremely challenging fication and inclusion), the incoming nego- major investment of the private sector in R&I. objectives have been set uniformly across tiation on the next EU FP (FP9) is a clear Attracting the private sector is indeed crucial each PPP, generating a huge complexity opportunity to correct and adjust the PPPs for achieving the 3% goal and finding solutions within the governance of each initiative. to enable their full impact and France will to the many societal challenges our societies In many PPPs, stakeholders complain support this approach in its position papers. are facing! that the processes are burdensome and
S t r e n g h t e nin g I nn o v ati o n an d Research in e u r o p e | The European Files | 9 Pushing a long-term vision for PPPs focusing on overlapping thematic areas, is Simplifying the partnership landscape and too complex and to be efficient, needs to be reinforcing effectiveness of the partnering reviewed. Taking into consideration the fact instruments should begin with a horizontal that a need for simplification and stream- and comparative analysis of all existing PPPs lining of the partnership environment was in research and innovation. Taking into con- indicated unanimously by Member States and sideration the importance of reducing the stakeholders during the interim evaluation of number of undertakings by, among others, Horizon 2020 and the fact that the High-Level combining the initiatives with similar inter- Group on maximizing impact of the European vention logic and overlapping areas of activity, Union’s Research and Innovation Programmes modifications in the current partnerships chaired by Pascal Lamy recommended to might become indispensable. Additionally, it cut the number of R&I funding schemes and is necessary to be aware of the fact that the instruments, there is no doubt that now – European innovation system is consistently Jarosław GOWIN during the preparation of the next Framework undergoing changes and, as a consequence, Programme – is the time to take appropriate requires creation and implementation of Polish Minister of Science and Higher actions in this regard. adjusted policy instruments. In this regard Education To fully seize the opportunities resulting the comparative analysis of existing PPPs from public private partnerships it is essential would be helpful to submit recommendations to adopt a strategic and holistic approach concerning replacing or adapting the current involving a broad spectrum of aspects that partnering instruments by the new, enhanced G should be taken into account in the future ones, that would be better aligned with lobalized and competitive economy the purposes jointly set by Member States and and society require new approaches to definition and operation of partnerships. the European Commission. solving crucial challenges we face. Well The above refers not only to an open and Redefining the role of partnerships in the designed, structured partnerships between the transparent process of topics selection – future European R&D&I framework is of public and private sectors could gain a more representing the interests of all Member crucial importance as it connects with the prominent role in the European research and States and being coherent with priorities recently proposed mission-oriented approach, innovation support portfolio. set out at European, national and regional that should be a major new element for In order to provide sustainable economic level in particular with Smart Specialization future Framework Programme. The concept growth and strengthen competitiveness at priorities – but also to the monitoring of of developing a coordinated mission-oriented both European and national level as well as established initiatives based on a set of duly approach for tackling jointly agreed challenges to adequately address societal challenges elaborated Key Performance Indicators. implemented by, among others, PPPs is an idea the European Union is facing nowadays we Among criteria measuring progress towards worth considering and needs to be further need well-structured partnerships between pursued objectives the following should discussed. the public and private sectors jointly framing be included: economic and societal impact A well thought-out design of public private and implementing research and innovation demonstrated as European Added Value of partnerships system can contribute to agendas. Properly functioning, long-term undertaken activities, as well as openness to achieving the core European policy objectives. public private partnerships in the area of sci- newcomers, including smaller R&I entities and By clearly defining the role of Member States entific research are necessary to achieve the SME’s, throughout their duration. As far as and industry in setting priorities and steering objectives of Horizon 2020 and the Europe the latter is concerned, it is worth underlining the process, optimizing the contribution 2020 strategy by, among others, enhancing that partnerships should be open not only at of public and private entities as well as by interdisciplinary approach in tackling the moment of their creation but throughout properly balancing top-down with bottom- emerging socio-economic issues, facilitating all their duration. Moreover, the abovemen- up approach, the instrument could provide introduction of innovative technologies on tioned approach towards PPPs should involve solutions to current and upcoming societal the European market, attracting interna- their mid-term evaluation and higher degree and economic challenges. Nevertheless, while tional research and development investments of flexibility, which would allow to implement reforming the partnership landscape it is nec- and decreasing fragmentation of sectors by necessary changes in justified cases including essary to bear in mind that any modifications building collaborative networks. assessment of a partnership relevance in should bring more simplification and trans- Given the considerable advantages of the contributing directly to competiveness and parency to the process with the aim of creating partnership instrument, it is crucial to make EU policy goals. Apart from the need for a a more efficient, accessible and open next full use of its potential. However, it seems strategic process of selecting and monitoring European Union’s Framework Programme for that the current landscape of public private of PPPs, it is essential as well to define from Research and Innovation. partnerships, which consists of multiple ini- the outset a phasing out strategy from the EU tiatives operating under different rules, with funding and a leverage effect for each newly different funding mechanisms and sometimes established partnership.
10 | T h e E u r o p e a n F i l e s | S t r e n g h t e nin g I nn o v ati o n an d Research in e u r o p e Preparing for FP9: Reinforcing JTIs and their potential research and industry that would otherwise top-level RTI and are the basis for competitive not be possible, the recent founding of the products and services in return. The par- initiative “Silicon Austria” as an investment ticipation in PPPs has thus become an integral programme to establish Austria as a prime part of the Austrian RTI-ecosystem. location for electronic based systems being closely related. In January 2017 the Austrian Ministry for Transport, Innovation and Technology has We welcomed the founding of the PPP published its position on FP9, following an “Shift2Rail” in 2014 and supported the joining intense discussion with the major repre- of the “Virtual Vehicle Austria Consortium+” sentatives of Austrian industry and applied and the company Kapsch CarrierCom AG as research. Based on the experience in FP7 and associate members. With its ambitious targets in Horizon 2020 this Position confirms the Shift2Rail helps to meet technology oriented high relevance and value of PPPs, however a Jörg LEICHTFRIED as well as societal needs, much in line with more transparent process when setting up the goals of Austria’s as well as of Europe’s new initiatives and more openness towards Federal Minister for Transport, Innovation policy to develop competitive and sustainable new partners have been asked for by some. and Technology of the Republic of Austria Noticeably the European Commission’s gen- transport solutions and boost the compe- erally very positive Mid-Term Evaluation of tiveness of industry at the same time. Again the PPPs confirms this analysis. RTI of this scale and scope requires long-term collaboration of the best in Europe and their T To conclude, we believe that JTIs will have to he Austrian Ministry for Transport, sustained commitment, supported by the be of continued relevance in FP9 and will have Innovation and Technology supports European Framework Program. to be reinforced, closely linked to enhanced since many years targeted research, national support of RTI and more ambitious technology and innovation (RTI)-programs in Alongside these two examples we are efforts in aligning national with European applied and industrial areas in domains such as interested and active in particular also in the priorities by European Member States. The transport, energy, ICT, industrial technologies, PPPs FCH2 (Hydrogen and Fuel Cells), CS2 support for PPPs within the Framework nanotechnologies, aeronautics, security and (Clean Sky 2), BBI (Biobased Industries) and Program for RTI will continue to be of space as a building block of its RTI-policies. The SESAR (Single European Sky Air Traffic Man- undisputed European added value, helping procedures followed are similar to the ones in agement Research), all of them corresponding at the same time to meet societal challenges, Horizon 2020. The programs have proven to be both to RTI and policy goals of the Ministry. pursue European policy goals and boost the money spent well, being crucial to enhancing Compared to the support of individual col- competiveness of Europe’s industry.” Austria’s competitiveness, both of research laborative projects these large European and of industry. initiatives require long-term commitment and investment by the actors involved but We are also active in supporting Austria’s they offer a great range of opportunities for participation in the industry-driven European Public Private Partnerships corresponding to the above-mentioned RTI-domains since their beginnings. This international collabo- ration in large-scale consortia with the best industrial and research actors across Europe is of high relevance both for achieving European goals and for increasing the quality of our national programs. This collaboration allows us - as a comparably small RTI-actor - to play prominent roles in large consortia – this would otherwise not be possible. One example is the JTI ECSEL (Electronic Components and Systems for European Leadership). The Austrian participation is linked to our national programs in ICT as well as in nanotechnologies and the Austrian contribution is financed by these programs. The collaboration within ECSEL offers immeasurable opportunities to
S t r e n g h t e nin g I nn o v ati o n an d Research in e u r o p e | The European Files | 11 Regional Impact of Joint Technology Initiates and Public-Private Partnerships for European Competitiveness and Innovation strategic priorities, multidisciplinary approach Innovation arises from the ground, from the and investing better in project preparation everyday needs of the everyday users. Inno- and contract management. vation is co-creation, and the Joint Technology Initiatives are an inspiring example. They rep- For bench-learning and awareness raising of resent positive change at EU level. By getting cities and regions and a step towards European people, researchers and businesses – together partnerships, joint initiative Knowledge with the public sector – to think, plan and Exchange Platform was launched two years execute is the best way forward for European ago between CoR and DG RTD. The Joint competiveness. Technology Initiatives (JTIs) are the aims to attract more consistent private investment, The European Committee of the Regions promote research and innovation along whole can make a difference. Our focus is on kick- value chains, to overcome fragmentation, to starting sustainable growth based on more Markku MARKKULA avoid duplication and to coordinate better partnerships. Local and regional authorities innovation activities. JTIs like BBI intend to have proven their worth in identifying local The First Vice-President of the European de-risk in research, demonstration and com- needs, bringing partners together and stimu- Committee of the Regions (CoR) and City mercialization of technologies and to respond lating investment in the real economy. Entre- councillor of Espoo to the challenge of creating and maintaining preneurship, capacity building, smart speciali- a competitive position of Europe. The main sation and risk-taking must be the mantra of positive effects in terms of competitiveness EU spending. Every region and city can be a E of technologies come via encouragement and pioneer in societal innovation and public- urope today is different than it used to private partnerships. be. In the face of economic and political support of value chain driven cooperation turbulences as well as global megatrends, across sectors (‘the structuring effect’) and To conclude, geography matters and pro- there an increasing will to incorporate the via innovation driven mobilization of key ductivity in regions are directly connected voices from regions and cities from the stakeholders (‘the mobilizing effect’). Flagships with aspects that have a strong impact on bottom-up into decision-making in Brussels. projects are one of the distinctive measures of people’s wellbeing: wellbeing indicators can The European Committee of the Regions CoR JTIs. Overall, JTIs have created a stimulating help rally behind strategic objectives. Regions has a crucial role to represent these opinions research and innovation environment in and cities are at the heart of European com- and concerns. Europe, which we should continue to foster petitiveness and innovation. The European for the European competiveness. Union must become a union of citizens; the Our work is guided by our political priorities, CoR reconnects Europe with its citizens by agreed in the June 2015 Plenary for the whole According to benchmark study done, one encouraging dialogue and collaboration with five-year mandate until 2020. One of the of the main challenges is the preparation; we local and regional representatives as well major CoR initiates is the Reflecting on Europe need better well-structured public-private as enforcing subsidiarity – taking decisions project. Our starting point is to show that the partnership (PPP) projects to attract emerging closest to the citizens. We need to be true European Union can and must work for our markets and private sector investments to believers of Europe and European compe- communities and citizens. However, for this to make regional impact on European com- tiveness and Innovation. happen, we need to achieve a mindset change petiveness. There is considerable scope to – a transition towards entrepreneurship and improve practices related to the disclosure of open innovation, experimentation and action information as well. In addition, we should find instead of planning, planning and planning. the right balance between strategic priorities This can be done together with closer coop- and encouraging companies to submit inno- eration between regions and cities but also vative project ideas and maintaining the trans- industries in public-private partnerships. parency and efficiency gains of a competitive tender process. We need good governance, public and private, for implementing better policies for The future is built on increasing synergic better lives and solving today’s challenges in collaboration between regions and cities different parts of Europe and its neighbours. throughout Europe. Good start has been the We need a new way of thinking. This means thematic Smart Specialisation Platforms which that we need to focus on how we do things have brought together 100 regions working in better, instead of only focusing on what we do. 20 interregional partnerships in a broad range New cross-border and cross-institutional part- of areas. nerships are needed and we must embrace a
12 | T h e E u r o p e a n F i l e s | J T I s S e c t o r s : N e w A m b iti o n s – N e w S c a l e IMI contributes to efforts to accelerate access to affordable, innovative medicine a bigger market means bigger potential. That for JTIs in the MFF for 2020+. The discussions is why the Innovative Medicines Initiative Joint have already started. For future EU financial Undertaking (IMI) was created in 2007. support, high quality outputs are essential. The key objective of IMI is to speed up devel- What are they? Around 90 projects run opment of innovative medicines and their under the IMI I and IMI II, which represents accessibility to patients. It serves as a platform hundreds of new discoveries. By end of 2016, for cooperation of dozens of participants on 33 patent applications were filled, mostly by every project such as academics, doctors, academia, research organizations or SMEs researchers or SMEs. IMI even managed to from 15 countries, some patents have already bring together big competitors from the phar- been awarded. Many projects resulted in maceutical sector, which illustrates the sig- spin-off activities. They generated new foun- nificant potential of the JU. The ever-growing dations, non-for-profit organizations, national engagement of patients is another big plus of platforms, research hubs or spin-out com- Miroslav POCHE the concept. panies. The citation of IMI projects in scientific Miroslav Poche, MEP (S&D Group), Member IMI’s project portfolio is varied. While gen- publications has been more than double of the ITRE Committee erally focused on challenging diseases (brain compared to the world average, with fields of disorders, cancer, metabolic or infectious genetics and clinical neurology topping the diseases or development of vaccines), the list. IMI projects delivered almost 200 new projects seek to reach specific research goals definitions and mechanisms in the sphere of of both a qualitative and a quantitative nature. drug discovery, concerning for example Alz- E very person eventually becomes a The backbone of IMI consists of the EU and a heimer and Parkinson. It speeded up devel- patient. Our health is our priority and pharmaceutical consortium called EFPIA, but opment of innovative medicines in the areas we are very sensitive to anything con- previous successes have attracted interna- of autoimmune and inflammatory diseases, nected with the well-being of ourselves and tional partners like the Bill and Melinda Gates vaccination or drug-resistance. Projects iden- our nearest and dearest. The medical devel- Foundation, the International Diabetes Fed- tified different biomarkers or new plasma opment has made fantastic progress in recent eration or Autism Speaks. proteins and contributed to the development decades, which can be illustrated, for example, With a total budget of €3.276 billion for the of new antibiotics. Thanks to IMI, unprec- by drastically decreased cancer mortality. Yet period 2014-2020, the EU should contribute edented pan-European platforms, networks many suffer because of non-existing or even 1,638 billion euro through Horizon 2020 to and databases have been set up to speed up inaccessible treatment. Widely-spread but be matched by the private sector (namely the process of clinical testing. Thousands of not fully explored illnesses exist in parallel to EFPIA and its members), financially or in-kind. people have been educated and trained for a rare illnesses for which the drug development Pharmaceutical industries are never recipients successful implementation of discoveries. process simply is too expensive. And many of any funding from the programme. On the The challenges for medical research and patients don’t have enough time. contrary, universities, researchers and patient industry are endless and the resources are The pharmaceutical industry is often crit- organizations, SMEs and mid-sized com- limited. The IMI Joint Undertaking projects icized for being too profit-led; however, the panies receive funding, often from industrial have demonstrably boosted medical research development of any new drug is an immensely members of the same project consortium. This and development and thus diminished the complex process that costs plenty of money. financial model has proven to be a success and forever-existing gap between needs and Profitability is an essential condition for the has become a model for financing other JUs. resources. Measurable results such as the sustainability of every business, including the The significant budget allows the Joint number of studies or patents are easily proven; pharmaceutical one, and whereas you cannot Undertaking to deliver remarkable results however, the unmeasurable effects - coop- buy health for any money, without money you and its financial management is under a per- eration, best practices or changing business cannot develop new treatments. Companies manent scrutiny. The European parliament thinking - are equally important. In my logically hesitate in situations of high risks plays an essential role in this respect as the opinion, IMI does exactly what should be done and uncertainties. Fast development of new final authority in the auditing process granting at a Europe-wide level and I believe that this drugs requires involvement of a large number the discharge for IMI. The European Parliament will be reflected in the EU budgeting for the of stakeholders (hospitals, research institutes, also decides about the budget, in particular 2020+ period. patients, SMEs or medical regulators together when it comes to EU money going to the with pharma-industry) because a lot of data envelope for Joint Technology Initiatives/Joint and other inputs are necessary. Undertakings and a degree of co-financing. Doing all of this at a European level is much The outcome from the mid-term review of more efficient than at a national one because Horizon 2020 will outline the future support
J T I s S e c t o r s : N e w A m b iti o n s – N e w S c a l e | The European Files | 13 PPPs: The Patients’ View partnership can only be achieved through ethical aspects of the project, including con- solid and transparent governance measures flicts of interest, including – amongst others: and a strong ethical culture between all ›› Interaction and communication within partners. The European Patients Academy on the Consortium; Therapeutic Innovation – EUPATI project, for ›› Generation and dissemination of infor- instance, offers a good example of a clear and mation to patients; genuine ethical governing structure. ›› Communication within the EUPATI Network; EUPATI ›› Communication to patients and public This patient-led academy leads an ambitious at large. programme to develop educational material, Adherence to the EUPATI Code of Conduct by all EUPATI members ensures trustful and training courses and a public Internet library successful execution and completion of the to educate patient representatives and the lay Nicola BEDLINGTON project. The EUPATI Code of Conduct was public about all processes involved in med- collated with reference to: EPF Secretary General icines development, with a current focus on ›› WMA Declaration of Helsinki, 2008 and training courses and expert meetings. Under 2011; the framework programme of EPF, EUPATI ›› CIOMS 2002 International Ethical brings more than 30 partners from academia, Guidelines for Biomedical Research civil society, patient organisations and phar- Involving Human Subjects; maceutical industry together. P ›› EMA Policy on the handling of conflicts utting patients at the centre of research The governance principle of EUPATI sees of interests of scientific committee projects is a long-standing priority for an Executive Board comprising two repre- members and experts, April 2012. the European Patients’ Forum (EPF) and sentative of each stakeholder involved in the The ‘EUPATI Code of Conduct’ outlines the its membership, and is a pillar of the vision of PPP with equal voting rights: patient organi- working culture and spirit of “assumed good the organisation. EPF has been participating in sations, NGOs & Academia, pharmaceutical intent” within the Project Consortium, while projects of various shapes and forms for more industry, and the EUPATI National Platforms the ‘Ethical Framework’ outlines the ethical than a decade now and our credo has always Network (national level PPPs replicating the ground rules of the project. been to represent patients as meaningful EUPATI model)This ensures patient organi- Members of the ethics panel and advisory partners, with co-deciding roles and strategic sations are involved in all strategic decisions network continue to offer guidance to the positions in the governing bodies. of the programme, with equal rights when it EUPATI Programme since it was established comes to steering the wheel in one direction as a permanent programme under EPF in April Governance and Ethics or another. 2017. We believe governance and ethics are The economic crisis had a massive impact However, a balanced and democratic critical success factors for a PPP to achieve on budgets of EU Member States, including governance structure is only one part of the its goals, whilst maintaining the credibility, budgets for research and public health equation. Having in place a strong ethics quality and resonance of their work, will be projects. This new situation accelerated the policy is another essential component of a the strength of the collaboration between the development of public-private partnership well-organised PPP. partners and the creation of an environment (PPP) funding mechanisms in research, a coop- The EUPATI Ethical Framework establishes and working culture for each of them to con- eration arrangement between two or more the core ethical principles to which all EUPATI tribute in a constructive, productive way, and public and private actors, putting together Consortium members, as well as the members in a spirit of respect and dynamism. resources for potential projects. of sub-committees, are required to adhere to. The European Patients’ Forum (EPF) is PPPs can offer a sustainable alternative The elaboration of this EUPATI Ethical an umbrella organisation that works with to research funding. By leveraging larger Framework was provided under the IMI patients’ groups in public health and health resources, it enables more projects to be project which established the EUPATI Pro- advocacy across Europe. Our 74 members rep- funded or continued and allows initiatives to gramme by the EUPATI Ethics Panel (2 co- resent specific chronic disease groups at EU grow with stability. leaders from academia and a patient deputy level or are national coalitions of patients. EPF However, their complex and hybrid funding co-leader). reflects the voice of an estimated 150 million mechanism require a sound and serious The core remit of the EUPATI Ethics Panel patients affected by various chronic diseases budget management, with proper in-house was to provide the infrastructure and access to throughout Europe. checks and controls process while retaining the required intelligence and genuine expertise flexibility and trust for the participants of the in ethics and law as pertains to the medicines More information: www.eu-patient.eu - potential project. development processes and patient advocacy. info@eu-patient.eu This is where governance and ethics play an It advised the Project Steering Committee, important role. We believe a true and mature Executive Committee and Work Packages on
14 | T h e E u r o p e a n F i l e s | J T I s S e c t o r s : N e w A m b iti o n s – N e w S c a l e The Innovative Medicines Initiative: taking open innovation to the next level IMI projects are accelerating the patients for clinical trials. To date, there are seven clinical trials and studies involving the medicines development process COMBACTE networks, covering studies on the During the earlier stages of drug discovery incidence, treatment and outcomes of certain and development, scientists deploy a range types of infection, as well as clinical trials of of tests and tools to study diseases, identify novel anti-infectives. potential drugs, and determine whether In the field of Alzheimer’s disease, our EPAD a potential drug will actually be safe and project is establishing a group of 6 000 people effective in humans. Currently, the results of at risk of developing Alzheimer’s who could these tools are often unreliable as they do not be rapidly recruited into innovative clinical accurately replicate what is happening inside trials of drugs designed to prevent or at least the human body. To address this issue, many delay the onset of the disease. Currently 10 IMI projects are delivering improved tests and sites across Europe are recruiting volunteers, tools. Pierre MEULIEN and the project hopes to start the first trials For example, our ORBITO project designed in 2018. Executive Director, Innovative a new tool, based on an artificial membrane, Medicines Initiative for predicting how a drug will be absorbed in the body. Several companies have integrated IMI projects deliver resources ORBITO tools into their R&D processes. that are accessible to the wider Elsewhere, our PREDECT project developed research community the first animal model of a common form of Many IMI projects are delivering resources breast cancer that faithfully replicates the for drug discovery that are open for use by human disease. The model has been hailed as the wider research community. These include ‘a potential game-changer for breast cancer online platforms that allow scientists to T he Innovative Medicines Initiative research’. rapidly find the information they need in just a (IMI) has now launched close on 100 In the respiratory disease field, our PRO- few clicks, as well as physical facilities that offer projects, and these are delivering active project developed patient-reported researchers the opportunity to identify and results that are already making a dif- outcome (PRO) tools for chronic obstructive further develop potential drugs. A catalogue ference to the medical research and drug pulmonary disease (COPD) which accurately of resources developed by IMI projects can be development community. Looking to assess patients’ activity levels and the impact found in the ‘Projects and results’ section of the future, we are committed to pushing of the disease on their daily lives. The tools the new IMI website. the boundaries of open innovation, by are being used by companies, including at One important contribution of our projects expanding the involvement of other sectors least one from outside the project, and are to the wider community is knowledge, as dis- (including diagnostics, medical technology, currently under review with the European seminated through publications in scientific digital technologies, human nutrition and Medicines Agency (EMA). journals. By the end of 2016, IMI projects had animal health) in the IMI community, and Another project whose outputs have published over 2 600 papers in the scientific by strengthening our ties with similar ini- received support from both the EMA and the literature. What’s more, the citation impact tiatives elsewhere in the world, especially on US Food and Drug Administration (FDA) is (which measures how often a paper is cited in issues with a global impact like Alzheimer’s SAFE-T. The SAFE-T team developed improved subsequent papers) for all IMI papers is 2.03. disease and antimicrobial resistance. tools for the prediction, detection, and moni- This is almost twice the EU average and is com- toring of drug-induced injuries to the kidney, parable to that of other organisations with a IMI was launched in 2008 as a public-private liver, and vascular system, using markers in similar remit to IMI, namely the Wellcome partnership (PPP) between the European patients’ blood and/or urine. Application of Trust (2.05) and the US Foundation for the Union and the European Federation of these biomarkers will make drugs safer, and National Institutes of Health (1.96). Analyses Pharmaceutical Industries and Associations reduce the number of drugs that have to be also reveal that just over a quarter of papers (EFPIA). Since then, we have launched almost abandoned late in development. from IMI projects are ‘highly cited’, meaning 100 projects, all of which take a collaborative, IMI projects are also delivering new they are in the top 10 % of papers by journal open innovation approach to some of the networks for running clinical trials. In antimi- category and year of publication. biggest challenges in medical research and crobial resistance, IMI’s COMBACTE family One of IMI’s most high-profile projects drug development today. Our successes amply of projects is building self-sustaining, pan- delivering resources for the scientific com- demonstrate the value of this approach, as European antibacterial development networks munity is the European Lead Factory. Here, our projects are delivering knowledge, tools and is using them to run high-quality clinical 7 pharmaceutical companies contributed and resources that scientists are using in their studies. For example, CLIN-Net is a network of compounds from their own collections daily work to improve the drug development over 800 hospitals in 42 European countries to create an initial joint collection of over process. capable of quickly and reliably recruiting 300 000 compounds. Since the start of the
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