FP7, Seventh Framework Programme for Research and Technological Development; IMI, Innovative Medicines Initiative; SICA, specific international co-operation actions; SME, small and medium-sized enterprises.
With a budget of €6.1 billion for the period 2007–2013, the Health theme of the Seventh Framework Programme for Research and Technological Development (FP7) 1, 2 represents almost 19% of the EU FP7 budget for collaborative research. This provides a significant drive for the improvement of the health of both European citizens and global health and also for the competitiveness of European health related industries and businesses.
By funding transnational collaborative research projects, FP7 Health brings together excellent teams of innovative researchers from different European and associated countries as well as other international partners, working in universities, research centres, hospitals, small and medium enterprises and large industries and associations, all cooperating on ambitious objectives that would be impossible to achieve alone or in a single country.
The participants in these projects enjoy the benefits of working co-operatively in a consortium composed of partners with a complementary range of skill sets and areas of expertise. This means that they are able to tackle significantly larger objectives than would be possible if working alone, by virtue of increased financial or human resources, access to samples or infrastructures and so on. Furthermore, projects can feature partners with expertise not only in knowledge creation and research but also in knowledge exploitation and innovation. Thus, there is the opportunity for teams to develop and diversify their science and technology-based knowledge in various domains as well as the ability to undertake staff exchange and training.
The Seventh Framework Programme for Research and Technological Development Health also provides greater flexibility than one might think or recall from past programmes. Apart from the minimum criteria for eligibility to receive funds from FP7 Health (that a project proposal should include a minimum of three partners from three different European countries and should respect the upper limits for the EU contribution per project set for each topic), the size and composition of the consortium, as well as the duration of the project is left entirely up to the applicants. Similarly, though the basic rules stipulate that all participants must be legal entities, there are no special conditions regarding the types of organisations or their geographical locations, except when this is expressly stated in the topic description (e.g. for small and medium sized enterprise (SME), topics or specific international co-operation actions (SICA) topics).
These opportunities and flexibilities are clearly reflected in the recently published FP7 Health 2011 work programme 3 and corresponding calls for proposals (with closing dates of 13th October and 10th November 2010, dependent on application type). The main feature of these calls is their support for innovation, in line with the Europe 2020 strategy 4.
Ten (of a total number of 51) topics encourage the strong involvement of SMEs and stipulate that a minimum percentage (15 or 30%) of the EU grant must go to the SMEs involved in each project. Consequently, SMEs will have a central role in these projects.
Included among these are two ‘high impact’ research initiatives which will support ambitious research projects in immunisation and in epigenomics. These projects will take a programmatic approach, typically comprising several interrelated research components. They are driven by the need to produce high impact outcomes; either direct results that can be implemented in pre-existing products or technologies (for instance, rational vaccination schedules for existing or new vaccines), innovations relevant to industry, products addressing societal needs and methods or European contributions to global cooperative efforts.
Ultimately, these high impact initiatives will aim to implement coherent and ambitious research strategies addressing the whole spectrum of research from basic (knowledge generation) to translational research and products, as well as education and training and involving experienced professionals who will jointly manage the planning and implementation of a common research programme.
The work programme also focuses on clinical trials with eight broad topics predominantly supporting investigator-driven clinical trials, aiming to provide opportunities to validate the safety and efficacy of various treatments and promote the translation of research into clinical practice.
There is also special emphasis on research to address lifestyle-related health issues, including diabetes/obesity, cardiovascular disease, brain related diseases and social determinants of health, as well as on global health issues, particularly anti-microbial resistance and emerging epidemics.
Successful proposals submitted in response to the 2011 work programme will be added to the 534 research projects which have thus far been selected for funding under the health theme, with an EU contribution of around €2.4 billion. Their selection is based on a system of peer review that is described by independent observers 5 as an example of best practice and could also act as a model for many national research funding organisations.
The projects are assessed by high level, international independent experts on their scientific and technological excellence, the quality and efficiency of the planned implementation and management and on their potential impact as a consequence of the development, dissemination and use of the results obtained. The work programmes are prepared with input from an international advisory group, composed of senior independent experts, under the guidance of Member State representatives as part of a ‘Programme Committee’ who gather opinions and recommendations from researchers in EU and associated countries, as well as from learned societies and from conclusions of international or European Commission-organised workshops.
In addition to these projects, FP7 has also seen the establishment of the Innovative Medicines Initiative (IMI) 6 joint undertaking, which will receive over its lifetime €1 billion in cash contribution from FP7 Health and €1 billion in kind from the European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies. IMI represents an innovative attempt to solve complex problems associated with the need to modernise and improve the drug development process. It is well known that European pharmaceutical R&D has not increased as fast as in other regions of the world in the last decade, while the total costs from research to market for a single drug are increasing. By bringing together industry and academic communities to develop pre-competitive tools aiding drug development, IMI provides a large pool of expertise to industry and early stage validation of work to academia, with the aim that Europeans should benefit from improved pharmaceuticals and a flourishing industry.
The impact of projects is not solely defined by the size of their budgets, however. By contributing to the organisation of the Member State-driven joint initiative aiming to tackle neurodegenerative diseases 7, the health theme provides leverage for the coordination of Member States' research programmes which taken together represent a significant effort. This so called ‘joint programming’ initiative recognises the impact that neurodegenerative diseases, in particular Alzheimer's disease, have and will have on an ageing European society. As the baby-boom generation retires, the number of people over 50 is rising by 35%; the population of over 60's is increasing twice as fast as prior to 2007 (two million a year), and those over 85 will triple by 2050. The joint programming initiative aims to facilitate Member States joining forces to establish a strategic research agenda to tackle the scientific, clinical and increasing societal challenges of these diseases which dramatically increase in prevalence with ageing.
Similarly, the theme promotes cooperation with international partners with the possibility of involving partners from any part of the world, in most cases with EU funding. For example, the recent coordinated FP7-Africa-2010 call for proposals addresses research aspects of the Africa-EU strategic partnership. A number of health research projects will be funded, each featuring a minimum of two partners from African countries.
Though the theme is open to cooperation with partners from very many non-European countries, specifically targeted cooperation with other regions of the world has included the Mediterranean, Russia and India and in future may include Brazil, China, Latin America and elsewhere with clear European and global added value. In these targeted cases, FP7 funds are not necessarily set aside to fund partners from these countries directly (though this is sometimes the case), but funding of European partners is conditional on their cooperation with non-European researchers, following agreement between the relevant funding agencies from the target country to publish similar calls for proposals in what is known as ‘programme-level’ cooperation.
At the mid-point of FP7, the arrival of the new Commissioner for Research, Innovation and Science, Máire Geoghegan-Quinn, represents an ideal moment to reflect on future priorities for the health theme of FP7 and beyond. Commissioner Geoghegan-Quinn has repeatedly emphasised how research will contribute to the delivery of objectives of the Europe 2020 strategy, expressing her intention to publish an Innovation Union Plan in the autumn of 2010. That plan will refocus research and innovation policies on the so-called grand challenges facing our society, such as climate change, energy and food security, health and an ageing population. It will also maintain the commitment to the development of the European Research Area.
Working towards these goals will contribute to the critical assessment of the current portfolio, with the development of existing health research policy in the next Framework Programme, ensuring continuity for the successful parts of the programme and providing impetus to build on those parts which have shown positive results. The importance of the health theme in Europe 2020 has been emphasised by both President Barroso and Commissioner Geoghegan-Quinn. Investments in research and innovation are clearly vital if Europe is to maintain its position as a provider of excellent healthcare and a global leader in medical research.