EN

Brussels, 10.4.2007

SEC(2007) 441

COMMISSION STAFF WORKING DOCUMENT

Document accompanying the

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

on the mid term review of the Strategy on Life Sciences and Biotechnology

{COM(2007) 175 final}

This Working Paper has been prepared as support for the European Commission’s Communication on the mid term review of the Strategy on Life Sciences and Biotechnology (hereinafter "the Communication").

1. Background

In January 2002, the Commission adopted a Strategy for Europe on Life Sciences and Biotechnology [1]. This was in response to the importance attached to life sciences and biotechnology by the European Council. It proposes a comprehensive roadmap up to 2010 and puts the sector at the forefront of those leading technologies which are helping to take the European Union towards its long-term strategic goal established by the Lisbon European Council in March 2000.

The strategy set out by the Commission consists of two parts: policy orientations and a 30 point plan to transform policy into action. It sets out what was is needed from the Commission and the other European Institutions, but also recommends actions for other public and private stakeholders. The strategy therefore provides a framework and a reference point both for action undertaken by the many stakeholders concerned within their own responsibilities and for co-operation between these stakeholders.

The Commission has reported regularly on the progress made and adopted progress reports, supported by Staff Working papers in 2003, 2004 and 2005. The 2005 progress report [2] foresees that the Commission will:

– Carry out an independent study aimed at providing a comprehensive assessment and cost-benefit analysis of the consequences, opportunities and challenges that applications of modern biotechnology present for Europe in terms of economic, social and environmental aspects,

– Draw on both the study and an in-depth assessment of the progress achieved since 2002 to update the Community Strategy on Life Sciences and Biotechnology in good time for the 2007 Spring European Council.

The study referred to in the first bullet point has been finalised by the European Commission in April 2007. It is available online [3]. In order to take full account of this study, it was decided to slightly postpone the mid term review after the original deadline of the 2007 Spring Council.

2. Objectives

The main objective of the mid term review, as mentioned in the 2005 progress report, is to reflect on the role of Life Sciences and Biotechnology in relation to the main European policy goals. This implies in particular an understanding of how the adoption of modern biotechnology in the various production sectors can contribute to the objectives of the European policy strategies on economic growth, sustainable development and environmental preservation.

It may already be understood that biotechnology goes far beyond the sole example of genetically modified organisms to be used in agro food, which actually represent only a tiny part of biotechnology. Modern biotechnology [4] plays an increasing role in the development of new treatments and preventions of diseases and the industrial landscape in Europe and elsewhere is steadily being transformed by the penetration of biotechnology into a large number of industries including food and feed, chemical, paper and pulp, textiles, and energy. New, eco-efficient and innovative industrial sectors (the "bio-economy") are emerging as biotechnology has introduced a new dimension to innovation in agriculture and other sectors, offering eco-efficient and cost effective means to produce a diverse array of novel value added products and tools. It has the potential to improve qualitative and quantitative aspects of food, feed, fibre and fuel production, reduce the dependency on chemicals and fossil fuels, diminish over-cultivation and erosion, and lower the cost of raw materials, all in an environmentally sustainable manner.

To reach the present objective, and following the request of the European Parliament, the Commission has undertaken the “BIO4EU” study to make an assessment of the economic, social and environmental impact of biotechnology and genetic engineering, including genetically modified organisms, in the light of major European policy goals formulated in the Lisbon strategy, Agenda 21, and sustainable development. Furthermore, the Commission has prepared a report [5] on the competitiveness of the European biotechnology industry and its possible contribution to growth and employment.

It appears from the analysis of the action plan that the Commission plays a major role in the development of biotechnology in Europe, in the field of research, education, regulation, finances, enforcement and international cooperation, this list being non-exhaustive. It is evident that, if all actions certainly have an interest, they do not all have the same priority in the current context, nor have they reached the same level of achievement (see Annex I for the refocused priorities).

In addition to this, the present Staff Working Paper presents a detailed overview of the progress made in implementing the action plan set out in the Strategy, the main achievements being highlighted in a chart annexed to this document (Annex II).

The present document, as well as the Communication describes how the Commission intends to pursue its involvement in the field of biotechnology, and the means it envisages to use. Nonetheless, the Commission is only one of the actors in the development of biotechnology in Europe, aside Member States and stakeholder who should also continue to implement the Strategy. The Commission intends to present the mid term review to other institutions and stakeholders, to explore how to maximise synergies and improve the implementation of the Strategy.

3. Procedural issues and consultation of interested parties

3.1. Procedure

The aim of the present Staff Working Paper is first to take stock of progress made on the actions contained in the original strategy from 2002, both from the legal/political perspective and on the basis of concrete facts, and assess what can be developed, improved, continued or simplified.

This report is based on contributions made by Commission services, as well as stakeholders and national authorities which were consulted in July-September 2006. It also builds on other Commission reports, on the implementation of specific sectoral legislation, such as for example Regulation 1829/2003 [6], and on horizontal issues (such as horizontal policies in the field of innovation).

On the basis of those elements, the Staff Working Paper presents an exhaustive review of all actions for the 2002-2006 period and makes suggestions for a simplified and refocused Life Sciences and Biotechnology Strategy for the 2007-2010 period, which are further elaborated in the Communication. To this extent, the current exercise goes beyond a mere reporting exercise and defines clear and concrete political objectives, with deliverables, for the 2010 perspective.

The Strategy was purposely large in content and actions, aiming at an initial mapping of the situation which would allow for identification of relevant policy areas. The Strategy has been successful in achieving this and most of the actions contained in the Strategy have been or are currently being implemented.

The preliminary conclusion is that the achievements are consequential and call for a continuation of the Strategy, which nonetheless needs to be partially refocused in view of the changes undergone since it was designed.

The second conclusion is that most of the actions appear to be still pertinent. This is somehow not a surprise given the very broad scope and long term perspective of the Life Sciences and Biotechnology Strategy.

Nonetheless, the corollary of this is that some of the foreseen actions, such as in the field of education or regional policy, are actually so broad that they are difficult to evaluate, since the relevant corresponding EC policies are not life sciences and biotechnology-specific.

The analysis of the implementation of the action plan relies on a list of priorities, which envisage three categories of action, those needing to be reinforced, those which should be continued and finally those which have been achieved. This constitutes the backbone of the political orientations contained in the Communication

Concrete deliverables have also been assigned for priority actions, which will permit a more thorough monitoring and evaluation of the current Strategy for the years to come, and help with reflection upon possible post 2010 initiatives.

3.2. Consultation of interested parties

A public consultation was launched on 5 July 2006 and was open for comments until 30 September 2006. It was addressed to a very broad range of "institutional" stakeholders [7], identified on the basis of contact lists proposed by all Commission services, and put online on the Europa webpage for contribution by all citizens [8]. The consultation was based on the 2002 Life Sciences and Biotechnology Action plan, complemented by emerging issues identified in the 2004 and 2005 Progress Reports.

This consultation allows drawing upon a wide range of views with respect to both the positive potential and short-comings of the actions.

The Commission received over 30 responses from individuals and organisations in 16 countries representing a wide range of stakeholders (consumer and patient organisations, farmers, NGOs and other interest groups, research organisations, private companies and individual citizens). The overall number of responses may appear very limited, but some of the answers received originated from very large organisations, both from the industry and NGO side, representing a very substantial number of companies or associations established at international level. While some stakeholders chose to provide only general comments assessing the Strategy, others chose to also submit detailed suggestions for refining specific actions. In general, the responses provide a positive assessment of the Strategy.

Aside from this consultation on the Action Plan, discussions on the mid term review have also taken place with the contact network with Member States ministries with responsibility for competitiveness in biotechnology [9], the industry and NGOs within the framework of the "Bio4EU" study [10], the Commission's Competitiveness in Biotechnology Advisory Group and the newly established network of high level officials on the Knowledge-Based Bio-Economy (KBBE-NET). Both industry and NGOs were satisfied to be consulted.

The conclusions from these different consultations are that the contributions are largely in agreement with the preliminary assessment done by the Commission and they match the suggested way forward described in the current Staff Working Paper.

4. Analysis of the implementation of the Life Sciences and Biotechnology Action Plan

Action 1 – Education and training

Reference to ongoing EU education programs will need to be updated to reflect the evolution of education programs "The Commission will, together with competent authorities in Member States, identify the education needs in life sciences within the ‘Ten-year objectives for learning in the knowledge society’ the education and training contribution to the Lisbon strategy and the 10-year work programme on Education and Training 2010 – and from 2007 on under the integrated Lifelong Learning Programme". After carrying out thorough research in the Compendia of Centralised Comenius Actions (Comenius 2.1 projects and Comenius 3 Networks) for the whole period of Socrates II programme (2000 to 2006 included), it appears that there is no project or network in the area of Biosciences and Biotechnology. There are many projects concerning sciences in general but none on biosciences. Despite the high importance of education it may prove difficult to go beyond what is already contained in the Action Plan and a general political recommendation to develop and strengthen education in the field of life sciences, given the absence of more specific sectoral information.

Action successfully implemented and will be further pursued

Action 2a - Match a skilled workforce with job opportunities

This action aiming at matching a skilled workforce with job opportunities is particularly important in the context of the Lisbon strategy.

The Commission established in 1993 the EURES portal in order to facilitate the geographic mobility of workers as a means to match job opportunities with appropriate and well-skilled candidates, and to contribute thereby to the development of a genuine labour market at the European level. The occasion of the 2006 European Year of Workers' mobility has provided considerable impetus to the portal, by enabling all EU citizens to access directly, in their own language, all job opportunities published by the Public Employment Services, i.e. around 1 million jobs at any given time. In addition to the access to job vacancies, the EURES platform offers the possibility for jobseekers in all activity areas to post their CV and access comprehensive and up to date information on living and working conditions in 30 countries. Beyond information provision, the EURES portal is supported by a network of 750 advisors, located in all EU regions, with the aim of providing customised assistance to workers and their families in all matters relating to their mobility experience.

The EURES Job Mobility Portal [11] is a key Commission initiative in this respect.

Action successfully implemented and will be further pursued

Action 2b – Fight brain drain

The Commission foresees a new "skill and mobility action plan", which will contribute to fulfilling the objectives of this action aimed at attracting and retaining scientists. The European Charter for Researchers and a Code of Conduct for the recruitment of researchers are now being implemented and a number of specific actions have been supported under the 6th Framework Programme for Research 2002 – 2006 (hereinafter "FP6"). The implementation of Action 2b will need to be updated in light of FP7.

In the frame of the integrated strategy the Commission has set out to enhance the quality and quantity of researchers in Europe. In March 2005 the Commission adopted a Recommendation to Member States on the European Charter for Researchers and a Code of Conduct for the recruitment of researchers. Together with the formal launch and unfolding across Europe of the ERA-MORE network [12] of proximity assistance to mobile researchers in 2004, as well as the Directive on the entry and stay in the EU of third country researchers [13], these are highlights of key steps towards the creation of a real European researchers’ labour market.

The European Charter for Researchers addresses the roles, responsibilities and entitlements of researchers as professionals and those of their employers or the funding organisations. It aims at ensuring that the relationship between these parties contributes to successful performance in the generation, transfer and sharing of knowledge, and to the career development of researchers. The Code of Conduct for the Recruitment of Researchers aims to improve recruitment, to make selection procedures fairer and more transparent and proposes appropriate means of judging merit, which should not be based just on traditional academic criteria, e.g. the number of publications, but on a wider range of evaluation criteria, including teaching, supervision, patents, spin-offs, other teamwork, knowledge transfer, research management and public awareness activities.

One year after its adoption various initiatives to raise awareness and support the implementation of the Recommendation have been undertaken at European as well as at national level. More than one hundred organisations all over Europe have already signed the Charter.

The Marie Curie actions in FP6 were conceived to give broad support for the development of abundant, dynamic and world class human resources in European Research systems. The actions comprise support for researchers at all stages of their careers from postgraduate researchers to senior professors with a number of aims: to facilitate movement between countries in Europe; to develop their careers outside Europe; and to attract the best researchers from around the world to come to Europe and undertake research. Support is on a bottom-up basis, across the entire range of scientific disciplines, with selection based on excellence. In all Marie Curie actions the life sciences are heavily represented and account for between a quarter and a third of the total budget.

To date in FP6, just over €500 million has been committed in the Marie Curie actions across the broad spectrum of life sciences and biotechnology in FP6. This support has taken various forms. It has enabled approximately 1000 experienced researchers to apply for individual postdoctoral support at the research institution of their choice in the public or private sector in Europe or in third countries. It has funded institutions to hire postdoctoral researchers to work on collaborative research projects. About 1000 full-time, three year PhD positions have been funded, allowing researchers at the beginning of their careers to access excellent foreign doctoral research programmes. Nearly €10 million has been used to fund conferences and dissemination activities. Funding for 45 teams has been provided (€70 million) to allow experienced researchers to set up their own research groups for the first time in industry or academia. Furthermore, 11 top-level “Chair” appointments have been made, attracting world-class researchers and encouraging them to resume their careers in Europe (€6.5 million).

The trans-national access activity of the Research Infrastructures programme has also provided opportunities for several thousand researchers to enjoy hands-on access to 35 life sciences research infrastructures, with tens of thousands also able to access some of these resources remotely.

Finally, a large number of the Network of Excellence implemented under FP6 include the programme “Integration and Strengthening of ERA”, which incorporates training and mobility activities.

The following provide a comprehensive overview of the different actions implemented in FP6 contributing to training and mobility of researchers in the area of Life Sciences and Biotechnology.

– 47 Research Training networks (€130 million) funding 400 full-time, 3 year PhD positions alongside more than 500 years of postdoctoral support;

– 61 Early Stage Training contracts (€90 million) funding 600 full-time, 3 year PhD positions;

– 50 Transfer of Knowledge “Development” contracts (€26 million) aimed at skills transfer mainly to Convergence Regions;

– 17 contracts (€7 million) to stimulate exchange and partnership between industry and academia in all areas of life sciences with a heavy emphasis on biotechnology, supporting 60 years of experienced researchers to move sectors temporarily;

– Approximately 500 individual, postdoctoral fellowships of up to 2 years duration for mobility within Europe (€100 million);

– Approximately 100 individual, postdoctoral fellowships for excellent European researchers to carry out research in a third country for up to 2 years and subsequently return to Europe (€25 million);

– Approximately 160 individual, postdoctoral fellowships to bring in excellent third country researchers to carry out research in Europe (€25 million);

– Approximately 200 experienced European researchers have been given grants (€16 million in total) to enable them to reintegrate in Europe following a longer stay in a third country;

– In terms of dissemination and exploitation activities, Marie Curie actions have supported 4 large conferences (€ 400,000) and 18 linked conferences/workshops/ summer schools (€8 million);

– Trans-national access of researchers is supported under FP6 to 35 life sciences research infrastructures, such as animal repositories, synchrotron beam-lines for structural biology, NMR (Nuclear Magnetic Resonance) installations, sequence databases or natural history sample collections. A total of 3500 researchers will have “hands on” access and tens of thousands of researchers will use the infrastructures remotely. These trans-national access activities have a budget of €22 million devoted to the life sciences, plus some smaller scale funding for training the infrastructure users;

– Projects exploring the use of e-learning on sustainable development and land use.

The investment in human resources activities in People and Capacities programmes has maintained the same approximate percentage of total FP funding (10% for People) as in FP6, which reflects the continued importance of investing in human resource following the Lisbon Agenda. No major changes are needed, the main thrusts of the People programme show clear continuation from FP6.

The strategies developed in previous Framework Programmes to attract and retain scientists and avoid brain drain will be built upon and continued. The Seventh Framework Programme (2006-2013) has an entire programme “People” dedicated to attracting and retaining researchers in Europe, and ensuring life-long career development opportunities. Continued efforts will be undertaken to attract the best foreign researchers and support the return of EU researchers established in other parts of the world.

In synergy with the activities proposed under the Communication "A Mobility Strategy for the European Research Area", the Commission launched in 2002 the "Skills and Mobility Action Plan", as a contribution to achieving the Lisbon objectives of more and better jobs, greater social cohesion and a dynamic knowledge-based society. The Action Plan, which was adopted by the Commission in February 2002 and endorsed by the Barcelona European Council in March 2002, aims at expanding occupational mobility and skills development, by ensuring that education and training systems become more responsive to the labour market, that administrative and legal barriers to mobility are duly removed, and that information about existing opportunities for mobility and related support mechanisms are set up, covering all sectors of activity in the EU. The final report for the Action Plan will be presented by the Commission. A new Action Plan, involving all operational Commission services dealing with mobility, is foreseen as a follow up to the European Year of Workers' Mobility of 2006.

On a very practical level the Commission is working on better co-ordination of the social security schemes of EU Member States and with third countries [14]. This is a key issue for persons exercising their fundamental right to free movement. This concerns e.g. the portability of pension rights but also the right to free movement with third countries (e.g. agreement on free movement of persons with Switzerland which entered into force in 2002).

Action successfully implemented and will be further pursued under FP7

Action 3 - Research

Under FP6

FP6 has brought a strong impetus to Life Sciences and Biotechnology research in Europe, in particular in terms of critical mass of human and financial resources, sharing of knowledge and facilities, strengthening of scientific excellence, coordination of national activities and support to EU policies.

The activities undertaken in the context of FP6 illustrate the broad application of Life Sciences and Biotechnology research to a large number of industrial sectors (e.g. health, food, agriculture, chemical, energy) and its continuing evolution integrating new and emerging disciplines such as the “omics” technologies (genomics, proteomics, metabolomics, glycomics…) as well as its convergence with other technologies (nano, info, cognitive and social sciences). The importance of Nanosciences and nanotechnology for underpinning the advances in life sciences and biotechnology was stressed in the Commission’s Communication “Towards a European Strategy for Nanotechnology” [15] adopted on 12 May 2004. The disciplines of synthetic and systems biology are gaining prominence at the embodiment of the future of biological sciences. [16].

Around €2512 million have been awarded for "Life sciences, genomics and biotechnology for health" research. These funds went to around 613 projects, involving more than 7600 participants. These projects ranged from fundamental genomics to applied genomics, poverty related diseases cancer, cardio-vascular diseases, diabetes, age and brain related diseases as well as rare diseases.

Another €756 million have been awarded under the thematic priority "Food quality and safety research". These funds went to 186 projects, involving more than 3032 participants. These projects ranged from food processing and safety to nutrition and food related diseases as well as agriculture-related research topics including animal and plant production systems, forestry, plant and animal biotechnology.

A number of projects dedicated to renewable energy based on biomass e.g. energy crops and agrowastes, were funded (approx. €20 million awarded) under the thematic priority "Sustainable development" in the specific programme "Sustainable Energy Systems".

A number of projects on innovative bioprocesses for water, water-waste, sludge, sediments and soil treatment/remediation have been funded under the priority "Global changes and ecosystems".

Socio-economic research was among others funded under the priority "Citizen and governance" addressing issues such as the dynamics of institutions and markets in Europe, indicators for emerging technology sectors and regional models.

Industrial biotechnology was a research area which during the implementation of FP6 emerged as an important eco-efficient innovative industrial sector. Industrial biotechnology refers to its use in manufacturing (chemicals, pharmaceutical, food and drinks, pulp and paper, textile, energy) at every stage in the process, from supply of raw materials to end-of-pipe and clean-up. It is seen as a key technology for the sustainable development of societies worldwide. Biological processes offer the prospect of cheap and renewable resources, lower energy and less waste consumption, reduction of greenhouse gas emissions, reduced dependence on (imported) petroleum and new markets for European agriculture. Examples of products already on the market include one of the most widely used fibrous polymers for household applications such as carpeting, a biodegradable plastic or use of enzymes in the manufacture of chemicals. This is a field in which European companies take a world lead. Industrial biotechnology is expected to contribute to a smooth transition from a fossil-fuel-based economy to a bio-based economy. Recent reports predict annual growth rates of 5% for fermentation products and a 10% market share of bio-based products within the chemical industry (around €100 billion value) [17]. Although numbers may differ, all reports agree that industrial biotech will play a significant role the future.

Several Member States (e.g. UK, Belgium, Germany, The Netherlands, Sweden, France…) have launched their own initiatives and additional public–private partnerships on Industrial Biotechnology have been set up recently in the Netherlands and Belgium. Australia, USA, Canada, and Japan and many emerging countries such as China, India, Brazil, and South Africa are stepping up their financial and strategic efforts to remain in the scene. An international dialogue is also taking place at the level of the OECD [18].

The Commission, recognising Industrial Biotechnology as a key industrial technology with great potential for sustainability (in line with the Environmental Technology Action Plan [19]) and cost efficiency, integrating different fields of research from nano-scale to engineering and production and with many sectoral applications, has for its part:

– Supported research in the area of industrial biotechnology for a total of €61 million (under the thematic priority "Nanotechnologies and Materials";

– Supported the launch of the “Industrial Biotechnology Platform” as part of the wider Sustainable Chemistry Technology Platform in order to boost this area in Europe;

– Ensured that Industrial Biotechnology becomes one of the priorities in FP7 under the theme “Food, Agriculture, Fisheries, and Biotechnology” as well as under the themes "Nanosciences, nanotechnologies, materials and new production technologies and "Energy". It will form an important pillar of the “Knowledge Based Bioeconomy”.

Industry, and in particular Small & Medium Enterprises (SME) have benefited from the FP6 .In the Health Research Priority 17% of all participating partners in projects funded are SMEs (representing around 14 % of the budget). As expected, the area “Application of knowledge and technologies in the field of genomics and biotechnology for health" attracted the highest number of industrial partners within Health Research Priority. The participation of SME's was in particular high in the diagnostic sector (42% of the proposals received in the specific SME call). Indeed the diagnostic sector is closer, its products are faster to the market and the risk is lower both financially and scientifically, compared to the drug and therapies sector. This situation is shared by investors and active owners of SMEs, such as venture capitalists.

Under the thematic priority “Food Quality and Safety" 19% of all participating partners in projects funded are SMEs (representing around 12 % of the budget).

In addition to the participation in the activities implemented under the priority thematic areas, two specific schemes for SMEs having a potential to innovate but with limited research capacity have been implemented. Within these schemes, SMEs or groupings dominated by SMEs may entrust research work to solve their particular problems to research performers (research institutes, universities etc.) About 23% of the budget allocated to these specific activities for SME’s has been attributed to research in the field of Life Sciences and Biotechnology.

Three main actions supporting Research Infrastructures in Europe were taken under FP6, with some focus on the Life Sciences and Biotechnologies:

– 20 projects dedicated to Life Sciences have been awarded an EU contribution of €66 million. Life Sciences will also benefit indirectly from a number of large multidisciplinary infrastructure projects such as access to synchrotrons, to neutron sources or to natural history museum collections, as well as use of the GEANT high capacity academic network, of the DEISA distributed infrastructure for supercomputing applications, and of the network enabling grids for e-science in Europe;

– The European Commission services initiated an exercise for mapping existing Research Infrastructures in Europe, in collaboration with the European Science Foundation and the EUROHORCs. This will assist in the gaining of an up-to-date picture about the current pattern, and will go towards understanding the needs for future Research Infrastructures;

– The Council of Ministers in its meetings of 1-3 July and 25-26 November 2004 also proposed to develop a strategic roadmap for new Research Infrastructures in Europe over the next 10 to 20 years. The European Strategy Forum for Research Infrastructures (ESFRI) endorsed this work and is now preparing a roadmap that will in particular cover several major projects for the "Biological and Medical Sciences".

In addition to this, the Commission is in the process of developing core competences in bioinformatics (including bioinformatics infrastructure). It has been accepted as a member of the European Molecular Biology Network (EMBnet) [20] which is the only organisation world-wide bringing bioinformatics professionals to work together. The combined expertise of the nodes allows EMBnet to provide services to the European molecular biology community which encompasses more than can be provided by a single node.

Concrete progress has been made in structuring the European Research Area and the active participation of all Member States has been achieved. The coordination of national policies has been initiated in the context of the Standing Committee on Agriculture Research (SCAR) and of the Member States Network on the Knowledge Based Bio-Economy (KBBE-NET). As announced in the 3rd progress report on the implementation of the strategy on Life Sciences and Biotechnology [21], the KBBE-NET has been established, bringing together high level officials from Member States, acceding and candidate countries to support the European Commission and the Member States to achieve a coordinated effort in the development and implementation of a European research policy for a knowledge-based bio-economy. This involves:

– Strategic discussion and recommendations for establishing a European Research Agenda in the long term (FP7, and beyond) which should allow the building of a European Knowledge Based Bio-Economy. The work should also contribute to the midterm review of the EU Life Sciences and Biotechnology Strategy in 2006-2007;

– Enhancing exchange of information between Member States regarding national research policies and mapping of activities including international cooperation;

– Enhancing cooperation between Member States (joint research programmes, common infrastructures, training programmes, etc).

A number of projects have been funded through the Specific measures in support of international co-operation - Developing countries on "Bio-diverse, bio-safe and value added crops" and on “Health of livestock populations” largely focused on the livestock health protection through the development and use of diagnostic tools and vaccines. This research area of the 'food security' priority makes use of advanced biotechnological techniques.

Coordination of national and regional research programmes has been achieved through the ERA-NET scheme [22] in which programme owners and programme managers identify national and regional programmes they subsequently coordinate or open up mutually. 15 ERA-NET actions relating to Life Sciences biotechnology are now implemented:

– Four ERA- NETS on Plant genomics, Biotech for SMEs, Pathogenomics and Systems Biology, have already launched joint calls for trans-national research projects using national funding. Together these projects have already committed some €80 million to these calls for 2007 and at least €50 million more for 2008.

– In the medical sector Era-Nets in the area of Organ transplantation, Health emergencies, and Health technology assessment have been implemented.

The establishment of technology platforms [23], an innovation in EU research policy, have continued to develop and foster public-private partnerships at European level. They represent a mobilising force by bringing together all relevant stakeholders in a given sector to develop a strategic, long-term research agenda and to implement the research agenda through public and private investments at European, national and regional level. They are expected to contribute to the effort to boost research and technological development in Europe and to leverage knowledge for economic growth and competitiveness. Industry’s lead role in the platforms is crucial in this regard. The industrial leadership of platforms ensures that they are focussed on potential future markets for key technologies. This leadership can provide the necessary impulse to realise Europe’s potential in leading-edge technologies and help to build the capacity to transform scientific excellence into commercial success and economic growth. It can also stimulate the emergence of first-mover markets in Europe. They provide a framework for industrial, scientific and financial worlds to come together and make viable projects that can only be conceived at European level. This in turn will boost research performance and investment.

So far 8 technology platforms in life sciences and biotechnology have now been launched: Innovative Medicines Initiatives, Nanomedicine - Nanotechnologies for Medical Applications, Plant genomics and Biotechnology, Industrial biotechnology under the sustainable Chemistry technology platform, Food for Life, Sustainable animal breading and reproduction, global Animal Health, Forestry and Biofuels. The last 6 technology platforms have established a virtual KBBE- Net in order to ensure a coherent and coordinated approach to the implementation of a Knowledge-Based Bio-Economy. Close collaboration between technology platforms and the KBBE related ERA Nets has been initiated.

Under FP7

The Seventh Framework Programme (2007-2013) will continue to provide a strong impetus to Life Sciences and Biotechnology research in Europe.

Life Sciences and Biotechnology research for medical applications will remain an important priority in FP7 in particular under the "Health" theme in the "Cooperation Programme". This theme will promote research to improve the health of European citizens and increase the competitiveness of the European health related industries and businesses. It will support both basic and applied collaborative research. This includes discovery activities, translational research and early clinical trials (normally only phase I and II). Activities will be structured in 3 main areas:

– Biotechnology, generic tools and technologies for human health;

– Translating research for human health;

– Optimising the delivery of healthcare.

The Health Theme emphasises the importance of innovation and the integration of SMEs in health research projects in order to reach the Lisbon goal, with special attention on the inclusion of 'high-tech' SMEs in projects. To that aim, in addition to appropriate work programme formulation of topics and calls, an articulated strategy is ongoing to improve visibility and awareness among the Healthcare SMEs community, through participation in international meetings relevant to SMEs including Trade Fairs, enhancing communication, supporting information multipliers and developing additional appropriate support structures.

As in FP6, and in addition to the activities implemented under the Themes of the Cooperation programme, a specific scheme is being developed to strengthen the competitiveness of SMEs, including Life Sciences SMEs, by enhancing their investment in RTD-activities (supporting SMEs or SME associations in need of outsourcing research to research services providers such as universities, research centres or research performing SMEs) and acquisition of intellectual property rights and knowledge.

The Innovative Medicines Initiative (IMI) [24] is expected to be established as a Joint Technology Initiative under FP7, forming a public-private partnership between the European Commission and the European Federation of Pharmaceutical Industries Associations (EFPIA). IMI aims at increasing the competitiveness of the European biopharmaceutical industry and is therefore a direct answer to the objectives of the Lisbon's Strategy. Industry will invest in research by co-funding collaborative research projects taking place in Europe, together with academia, SMEs, and patients associations supported by public funds. IMI research objectives are to provide new tools for accelerating the development of safer and more effective medicines for patients, by overcoming four key pre-competitive research bottlenecks in the drug development process: prediction of safety, prediction of efficacy, knowledge management, and education & training.

"The European Technology Platform on NanoMedicine [25] aims at strengthening the competitive situation for nanomedicine at global level. Its strategic research agenda puts forward a sound basis for decision making processes for policy makers and funding agencies, providing an overview of needs and challenges, existing technologies and future opportunities in nanomedicine. It also takes into account education and training, ethical requirements, benefit/risk assessment, public acceptance, regulatory framework and intellectual property issues. The initiative concentrates on three key areas: Targeted drug delivery, nano-diagnostics and regenerative medicine. The Platform delivered a sound basis for the work programme of FP7 in this area. Industry is ready to invest considerable funds in European nanomedicine research projects together with the European Commission and other stakeholders."

FP7 is also expected to contribute to building a European Knowledge-Based Bio-Economy, by bringing together research, industry and relevant stakeholders under the theme “Food, Agriculture and Fisheries, and Biotechnology” to exploit the new opportunities that life sciences and biotechnology offer to create added value in society, to enhance sustainability through the optimal use of renewable biological resources, to mitigate the emission of greenhouse gases, to provide new eco-efficient and competitive products and to reduce the adverse impact on the environment of agriculture, industry and aquaculture.

Three main areas of research will be addressed:

– Sustainable production and management of biological resources from land, forest and aquatic environments;

– “Fork to Farm”: Food, health and well being;

– Life Sciences and biotechnology for sustainable non-food products and processes.

This progress in science and research strongly contributes to the implementation of the objectives of the revised Lisbon strategy, as outlined in the "Kok report" [26]. Life Sciences and biotechnology will help to move towards a European Knowledge-Based Bio-Economy, where not only food and feed, but also other industrial goods are produced in a more sophisticated and sustainable manner by incorporating life sciences and biotechnology innovations. As an example, the chemical industries may undergo transformation at several levels: Firstly the industry may undergo raw material conversion from fossil feedstock to biological resources. Secondly, it may undergo process conversion from using chemical processes to using bioprocess.

These knowledge-intensive and eco-efficient bio-products include among others biofuels, bioplastics, green chemicals, lubricants, biopharmaceuticals, food and feed, as well as other bio-products.

The move towards a bio-based economy is not only taking place in Europe, but is emerging globally and our main competitors are now strongly investing in these areas of research.

As stressed in the recent "Aho report" [27], research, technology and innovation can only be powerful vectors of sustainable growth, if supply-side measures (public investment in research) are rebalanced with demand-side policies (public procurement, standards, regulation, ….) in order to stimulate private investment into research and product development. As expressed in the report, "simultaneous and synchronous efforts are needed at all levels in three areas":

– Creation of a market for innovative products and services;

– Providing sufficient resources for R&D and innovation and;

– Improving the structural mobility and adaptability of Europe.

A number of supply-side policies are already in place to support the emergence of a European bio-economy, in particular R&D support through national and Community research framework programmes. The KBBE-NET network was established in 2005 to exchange information on national research policies and programmes and to enhance cooperation between Member States (joint research programmes, common infrastructures, training programmes, etc) with a view to develop and implement a European Research Agenda for the knowledge-based bio-economy.

However, if Europe wants to explore the full potential of the “Knowledge Based Bioeconomy" it needs to engage in demand side policies to create dynamic market conditions. ("lead markets"). "Bio-based products" could be a prominent example of a European lead market given that Europe has some key strategic advances:

– A strong, world-class biotechnology R&D base;

– Key-enzymes producers being located in the EU;

– A strong chemical industry, which are leaders in the development and production of bio-specialities (food ingredients, pharmaceuticals and fine chemicals);

– The availability of renewable resources, in particular agricultural biomass through the recent EU enlargements;

– Strong political support for and more advanced concepts of sustainable development

– Strong public support for industrial biotechnology (according to the 2005 Eurobarometer on public perception of Biotechnology [28] 70% of the respondents supported bioplastic and biofuels and are willing to pay more for these products).

Such a lead market initiative for eco-efficient bio-based products should stimulate private investments and lead to more demanding and novelty-seeking customers, and potential higher returns on investment will act as a strong incentive to private research and innovation.

Several actions could be considered, both from the supply and the demand sides, to provide a push for eco-efficient biobased products. The list below takes into account the discussion at the Presidencies Biotech Policy Round Table in Helsinki in June 2006 [29] and the work of the network with high level officials on the Knowledge Based bio Economy. The Commission will further reflect on these actions, in cooperation with the concerned stakeholder, bearing in mind that some proposals may need to be subject to an impact assessment, including an evaluation of possible administrative burden, and compatible with EC rules in the field of competition and internal market.

(1) Providing sufficient resources for R&D and innovation

(a) Mobilise national research funding (e.g. re-enforcement of ERA-Nets) and reinforce the coordination of national research activities amongst others through the Member State network on KBBE. Special attention should be made to:

– Launching of demonstration projects/pilot plants at European/National/regional levels e.g. integrated diversified biorefinery;

– Implementation of the strategic research agendas developed by the Technology Platforms at European, national and regional levels.

(2) Creation of a market for eco-efficient bio-based products

(a) Establishment of standards/minimum requirements to claim a bio-based product is eco-efficient (bio-products that leads to less pollution, less resource-intensive production and more effective management of biological resources);

(b) Help convert conventional industrial processes into eco-efficient bio-based products by developing faster regulatory approval system for eco-efficient bio-based products;

(c) Secure affordable supply of biomass feedstock through supportive innovation programmes, agriculture policies and price incentives;

(d) Provide market incentives to stimulate the commercialisation of bio-based products:

– Include the issue of eco-efficient bio-based products in the EU green Public Procurement Policy in order to stimulate public procurement of eco-efficient bio-based products. The French Environment Agency Bioproducts guidebook for Greener Procurements may serve as a model;

– Establish EU labelling of eco-efficient bio-based products compatible with EC rules on eco-labelling.

– Temporary pricing measures.

(3) Improving the structural mobility and adaptability of Europe

(a) Enhance coordination and coherence of the various policy initiatives at EU level e.g. biomass action plan, ETAP, sustainable development strategy, implementation of the biofuel directive [30] etc;

(b) Enhance cooperation between the Commission and Member States among others through the Member States network on Knowledge Based Bio- Economy (KBBE-NET) in cooperation with Council Presidency;

(c) Continue to elaborate the KBBE concept, assess its potential impact and make practical steps to ensure its implementation. Developments inside and outside the EU should be monitored through, amongst other methods, the Member States network on Knowledge Based Bio-Economy (KBBE-NET) and interaction with the OECD;

(d) Enhance the collaboration with industry and other stakeholders through the technology platforms amongst other mechanisms.

(4) Create awareness amongst stakeholders

(a) Launch information campaign on eco-efficient bio-based products and the potential of the “Knowledge Based Bio-Economy” including interactions with civil society, NGOs, investors, policy makers etc;

(5) Promote interdisciplinary education and training programmes.

(6) Improve investment in eco-efficient bio-based SME's

(a) Attract new public and private investors

(b) Increase availability of seed funding for Eco-efficient bio-based start-ups by reassuring investors through the involvement of public funding bodies (EIF,EIB etc);

(c) Put incentives in place to motivate private individuals and foundations to invest in "green" investment funds.

(d) Better target the available funding at new technology projects.

Support for life sciences and biotechnology research under FP 7 clearly appears as a top priority. Hence the original "Action 3", which has already been achieved, needs to be revised to take into account the objective and structure of FP7. In addition to this, new sub-actions should be envisaged in order to provide a push for eco-efficient bio-based products and the implementation of the Knowledge based bio-economy. Such actions would certainly be relevant in a perspective of sustainable development. They may nonetheless require an impact assessment (i.e. as far as they foresee for example the establishment of standards to assess the eco-efficiency of bio-based products, of incentives for the marketing of such products or of specific eco-labelling).

The Commission will enhance its support for life sciences and biotechnology research, technological development, demonstration and training activities under the next Framework Programme 2007-2013 aimed at contributing to the creation of a knowledge society and to provide a more stable foundation for the European Research Area.Life Sciences and Biotechnology research will mainly be supported under the "Health" and the "Food, agriculture and Fisheries, and biotechnology" thematic areas under the Cooperation programme. The following thematic areas under the Cooperation programme will also contribute to the implementation of the strategy:Information and Communication Technologies;Nanosciences, nanotechnologies, Materials and new Production Technologies;Energy;Environment;Socio-economic Sciences and Humanities;Security and Space, notably biosecurity.Specific measures will be provided to encourage "investigator-driven research" in relation to the establishment of the European Research Council, mobility and training of researchers, coordination of national and regional programmes, SME participation, regional research driven clusters, research infrastructures, international cooperation and science and society issues. In the course of the mid-term review of FP7 in 2009 an assessment will be carried out regarding the accomplishment of creating a "European Knowledge Based Bio-Economy". The contribution in terms of human and financial resources from, in particular theme 2 "Food, agriculture, fisheries and biotechnology", theme 4 "Nanosciences, Nanotechnologies, Materials and new Production Technologies", theme 5 "Energy" and theme 6 " Environment, as well as the need for new strategic research priorities. The contribution from Member States, industry and other stakeholders will also be assessed. |

Action 3 remains of strategic importance, in particular in view of the emerging of industrial, environmental and marine biotechnologies as important sectors not only in Europe but globally. It needs to be refocused in light of the new FP7 and of emerging issues

Action 4 - Management and legal services

The two actions aiming at creating networks of biotechnology company managers and at developing specific legal competence in this field do not have triggered interest from the concerned audience. The two actions do not have any strategic importance at European level and do not need to be pursued further to the review.

The idea to create networks of biotechnology company managers has been probed but the Commission has found that there is no interest for this action at European level. The existing biotech clusters/regional organisations seem to fill the needs.

A reinforced collaboration between law schools, law firms and companies has not raised any interest at European level.

The needs to improve biotech companies’ business models, acquire legal competence and recruit competent leaders are often cited in various reports. As the European biotech sector gradually matures, these needs will be more accentuated, and the existing clusters and networks (including the recently created CEBR; see action 9) can provide the demanded services and networking possibilities.

Action 4 does not need to be pursued as a specific action

Action 5 - Patenting of new research findings

Intellectual property rights (IPR) have a special role to play in the life sciences and biotechnology sector. Biotechnology requires huge levels of R&D investment and in many cases it takes a long time to obtain legal approval for products to enter the market. The patents registered by a biotech company constitute a large part of that company’s value, being the company’s main asset to generate future revenues. Intellectual property may even be the one and only collateral to obtain financing for the company’s research and development activities. Therefore the acquisition of patents, a legal mechanism that ensures a return on investments is crucial to life sciences. IPR instruments such as trademarks, commercial names, domain names, know-how and licensing agreements secure the commercial interest of entrepreneurs in this sector.

While the patenting of new research findings in the field of biotechnology has economical and ethical implications, this action should be considered in the global context of research in general. Given its importance, which has been clearly confirmed by stakeholders, this action should be continued and remains a political priority. In particular, the economic consequences of not having a cost effective Community Patent should be studied. Ultimately, efforts should continue to agree and introduce a Community Patent, whilst it should be clear that this is not a biotechnology–specific issue and that only limited action can be taken for this purpose in the context of the Strategy.

Action 5 (a) has been achieved and all Member States have now implemented in their national laws Directive 98/44/EC [31] on the legal protection of biotechnological inventions. The Directive aims to clarify certain principles of patent law applied to biotechnological inventions whilst ensuring that strict ethical rules are respected. Such clarifications have proved essential in order to fully exploit the medical, environmental and economic potential of biotechnology in line with high ethical standards.

For its part, the Commission has considered two questions identified in the annual report [32] of the Commission to the European Parliament and the Council on the development and implications of patent law in the field of biotechnology and genetic engineering provided for by Article 16(c) of Directive 98/44/EC. Namely the scope of patents relating to sequences or part-sequences of genes isolated from the human body, and the patentability of human stem cells and cell lines obtained from them. These two topics have been addressed in the last Commission report [33]. The Commission is financing two studies. One on the impact of human DNA patents in research and innovation [34] that is expected to provide an evidence-based analysis of the features and dynamics of patent applications. The second study, which has also been launched in the beginning of 2005, will analyse the EU patent system as applied to human embryonic stem cell related technologies [35]. Results of studies will be analysed by the Commission and discussed with Member States.

Regarding action 5(b), after receiving the opinion of the European Parliament, the Commission proposal for a Regulation on the Community Patent [36] has been discussed in the Council, where, on 3 March 2003, a common political approach was agreed on a number of issues. Following this, there was significant progress in the Council in incorporating the common political approach in the text of the Community Patent Regulation and the text was practically finalised in November 2003. However, since then the Council has repeatedly failed to reach final agreement. In the meantime, the Commission has on 23 December 2003 presented proposals for Council decisions on the setting up of the Community patent jurisdiction [37]. The Economic and Social Committee has issued its, overall, very positive opinion on 31 March 2004 [38] and the European Court of Justice has delivered its opinion on these proposals on 29 October 2004 [39].

In view of the difficulties to achieve progress in the field of patents in Europe, the Commission has in 2006 carried out a broad consultation of all interested parties on the future patent policy in Europe. The consultation focused on the structure of the patent system rather than on substantive patent law. One of the main issues in the consultation concerned the Community patent but it covered also issues such as basic principles of the patent system, the draft “European Patent Litigation Agreement” and approximation of Member States' national laws and mutual recognition of Member States' patents [40]. The consultation ended with a public hearing in July 2006. Following this consultation, the Commission is now preparing its position on the way forward.

Action 5(c) has been partially achieved from the Commission side. An expert group on technology transfer and legal specialists finalised in 2004 a report on “Management of Intellectual Property in publicly funded research organisations – towards European Guidelines” [41] .

A Commission study providing a detailed comparative analysis of the Intellectual Property Research (IPR) rules applicable to publicly-funded research, their evolution and their effects, in the "old" 15 EU Member States, in 2 "new" Member States, as well as in the US and Japan was launched in December 2005. The study focuses on legislative aspects and gives recommendations in order to improve the coherence of the IPR regimes applicable to publicly funded research in the European Union.

Regarding action 5(d), the Commission has encouraged research organisations in the life sciences and biotechnology area participating in the EU R&D Framework programmes to actively protect, disseminate and exploit their research results. It has supported the BioBIZ project, which provides entrepreneurship training, in particular in the New Member States, and has recently published a brochure with "100 Technology Offers" [42] collected from results of EU funded R&D projects.

The Commission has supported a number of support actions to raise awareness for and provide training on IPR issues, such as the "ScanBalt IP Knowledge Network" project [43], which aims to spread awareness and competence development in the field of strategic IP management in biosciences. The EPIPAGRI project, starting in September 2006, will bring together major EU research and technology transfer organisations to collectively manage public intellectual property in Agricultural Biotechnologies, both to support better access to IP for developing countries and SMEs.

Regarding action 5(e), Member States and the Commission took part actively in an OECD exercise to develop licensing guidelines for genetic inventions. On 23 February 2006, the OECD Council adopted the Recommendation [44] , which presents Guidelines for the Licensing of Genetic Inventions. These set out principles and best practices for the licensing of genetic inventions used for purposes of human healthcare.

As a conclusion, the Commission, the Council and the Member States should continue to support the objective of the action.

In the biotechnology sector, patenting of new research findings needs to be done at an early stage to secure further investments and to realise its full economic value. Economic consequences of not having a cost-effective Community Patent should be studied, in particular for the realisation of European inventions originating from academia and young innovative companies

Developments in biotechnology may raise important ethical and legal questions with respect to their protection through patents, in particular in the area of human embryonic stem cells or the newly emerging area of synthetic biotechnology. Therefore special consideration needs to be given to the development of best practices for IPR taking into account ethical and societal concerns while encouraging patenting, licensing and spin-off creation.

With the increasing number of biotech patents, held both by the public and private sector, transaction costs will likely rise. To maintain the competitiveness of the EU industry, issues such as patent pools, research exemption and new models for the use of IP in public-private research partnerships are becoming important. The Commission, in cooperation with Members States and relevant stakeholders, should take a proactive role in initiating discussions on these important issues. In a first step the Commission is preparing guidelines on knowledge transfer between the public research base and industry across Europe (with an emphasis on the trans-national dimension) The guidelines which are expected to be adopted in 2007 will be addressed to public authorities and stakeholders.

Action 5 remains of strategic importance and needs to be continued in the appropriate fora. Biotech-specific aspects of this action also need to be refocused

Action 6 – Capital base

Regarding action 6a, the EIB's Innovation 2010 Initiative (i2i) aims to help increasing the spending on research, development & innovation in Europe by providing €10 billion in loans until 2010. More than €750 million in loans has been granted to the biotech & pharmaceutical sector.

The EIB loan facility has been strengthened by the introduction under FP7 of a new financing instrument, the “risk-sharing finance facility”, which will provide loans for larger research and infrastructure projects. It also aims to fund projects with higher risks. This facility, a joint loan instrument between the European Commission and the EIB, is managed by the EIB, and can provide finance for research in high technology areas by private companies and institutions, for which the risk cannot properly be assessed by classical banks and are therefore considered too risky.

FP7 funds will be used in addition to EIB and as a reserve to cover the risk associated with the EIB lending operation, thereby providing a leverage effect (factor of 3-4). This instrument can in particular be useful for financing high-risk biotech R&D drug development projects, large scale collaborative research projects (technology initiatives, Eureka projects) or new research infrastructures.

The Commission also supports the AFIBIO project ("Access to FInance in the BIOtech sector), a network of financing experts, including the EIF, to develop novel and innovate ideas related to innovation financing and providing policy recommendations.

Regarding Action 6b, the venture capital (VC) instruments of the European Investment Fund (EIF) consist of equity investments in venture capital funds that support SMEs, particularly those that are in their early stages of development and those that are technology-oriented. The EIF's venture capital activity is backed by two sources of funding: (a) capital from the EIB Group (EIB and EIF) that forms the bulk of the EIF's investments, and (b) capital from the European Commission that is allocated under three different programmes:

– The ETF Start-up Facility is intended to adopt a higher risk profile than the EIB Group operations. It aims to invest in venture capital funds such as seed capital funds, business incubators, smaller or newly established funds, funds focused on specific industries or technologies and funds financing the exploitation of R&D results (i.e. funds linked to research centres and science parks);

– The EIF-ERP "Dachfonds" was started jointly by Germany and the EIF to encourage venture capital providers to invest in German high-technology firms, but also elsewhere in the EU. The €500 million fund is expected to raise an additional €1,7 billion through commercial VC investments;

– A new Commission framework programme called the Competitiveness and Innovation Programme (CIP) will operate from 2007. It brings together several separate programmes and aims to strengthen the funding available to stimulate investments in research and technological innovation, especially in SMEs. An increase of €1 billion of the EIB reserves from CIP has been decided;

– Fully achieved. A “Technology Transfer Accelerator” (TTA) was launched in 2006 after the Commission and the European Investment Fund (EIF) had carried out a feasibility study on a new type of risk capital and technology transfer investment vehicle. It aims to link different centres of excellence and universities in European countries. The TTA should bridge the finance gap between university/spin-off research and early stage investment, a sector currently not favoured by VC investors. The Commission is also financing entrepreneurship training courses with particular focus on scientists in the New Member States.

Regarding action 6d, the EIB commissioned an external study in 2005 to find out how many European biotechnology companies are creditworthy, i.e. actually able to take debt for their product development. The study estimates that only very few European biotech companies qualify for debt financing (according to the strictest criteria). The main factors for debt financing are the maturity of the company and a steady flow of revenues.

In September 2005, the Commission produced a report on “Best practices of public support for early-stage equity finance” [45]. This document analyses the demand and supply-side of early-stage finance, gives examples of funds operating in Member States, and provides recommendations for improvement of early-stage finance.

An analysis of the European biotechnology industry’s competitiveness stance [46] was performed by the Commission early 2007. Europe's biotech companies are mostly SMEs with limited resources and they often depend on external investment capital to be able to follow through with their research and development projects. It is evident that in terms of research expenditure and number of employees European companies grow at a slower rate than their American counterparts. This can be attributed to three main constraints: Europe's fragmented patent system, the insufficient supply of risk capital and the not yet fully developed scientific and business cooperation. To remedy the under-funding problem a combination of demand and supply side measures are recommended.

Action 6 needs to be continued and highlighted as a political priority

Action 7: Biotechnology and Finance Forum

The Biotech and Finance Forum Advisory Board has been renewed and strengthened in 2002 to include all relevant stakeholders in Europe in the field of biotechnology and finance (EuropaBio, EFB, EVCA, EIB, EIF, etc.), as well as representatives of major bio-clusters, venture capital firms, consultants, etc. in the biotech sector. It has made important recommendations and initiated activities to improve access to finance, in particular for later stage companies and for the emerging sector of industrial biotechnology. Roundtable and investment conferences are organised twice a year (in December and May), bringing together industry, small companies, investors and policy makers. Recommendations of the Biotech and Finance Forum working group delivered in 2002 on "Financing of biotech companies" have led the EIB to provide an additional €500 million to the EIF to provide further venture capital to innovative SMEs, including for later stage biotech investments.

The European biotechnology industry has seen considerable growth during the late 1990s, in part due to strong policy initiatives to support university spin-offs, bio-cluster development, etc. While Europe has many biotech start-ups, there are still problems with getting adequate funding and making the European companies grow (US companies are on average better staffed and funded). Further growth seems to be hampered; possible reasons being the lack of access to early- and late-stage finance, and/or the small size of national markets and actual access to markets. An in-depth study of the factors hampering the growth of EU biotech companies is necessary in order to develop appropriate policy measures that could counteract a possible "value drain", i.e. an increased relocation of mid-stage EU companies to the US.

The biotechnology and finance forum to be established under this action is now established and operational, action 7 is thus achieved

Action 8a - Creation of a commercial biotechnology web portal

The creation of a commercial biotechnology web portal for Europe is near completion. An evaluation of the setup and the long term sustainability of the web portal should be made and the potential stakeholders should be mapped.

Action is near completion. An assessment of sustainability is required

Action 8b - Commission's central biotech web site

The Commission's central biotech web site is operational [47]. It will be regularly updated and provide necessary links to the Commission's different Directorate Generals' specific biotechnology related web pages.

The website is now established and operational, action 8b is thus achieved

Action 9a - Networking activities between biotechnology regions

The funding of a number of networking activities between biotechnology regions has facilitated the liaison between scientists and business, improving competitiveness.

The Commission has offered funding for a number of networking activities, either through the R&D Framework Programme (specific support actions through the Specific Programmes, and the Regions of Knowledge and INNOVA schemes) or through EU cohesion policy's INTERREG programmes. The Commission has recently launched a project, aimed at establishing a Council of European Bio Regions (CEBR). The aim of CEBR is to establish a long lasting network of bio-clusters and regional associations at the European level, thus facilitating better networking between scientists and business in the biotechnology area and improving competitiveness of the EU biotech industry. The inaugural meeting took place in June 2006

The INTERREG III cooperation programmes which are part of EU cohesion policy have supported projects to network biotechnology/life science regions in the framework of cross-border and trans-national co-operation programmes (INTERREG III A and B). Examples are set out below.

– Scanbalt Campus: This project, developed in the framework of IIIB Baltic Sea Region programme and in cooperation with the ScanBalt Bioregion umbrella initiative of the Nordic Innovation Centre, was founded with the aim of creating a model for trans-national and trans-sectoral institution-building in education, research and development. It includes 31 partners, most of them universities from the countries surrounding the Baltic Sea. The scope of this pilot project includes formulating the concept and structure of a virtual academy, establishing knowledge networks, identifying examples of shared curricula and creation of media services and visibility. The lead partner is the Chalmers/Göteborgs universitet, Centre for environment and sustainability (SE). The contribution of the European Regional Development Fund (ERDF) amounted to €462 405;

– Reducing the environmental impact of aquaculture: This cross-border co-operation project developed in the FYN-K.E.R.N programme between Denmark and Germany aims at supporting the sustainable development of maricultures and to increase the market share of edible fish in refined fish production. The project combines German expertise in land-based fish breeding with Danish knowledge of the management of algae growth to reduce the harmful effects of nitrogen in fish production. The lead partnersare Leibniz-Institut für Meereskunde an der Christian-Albrechts-Universität, Kiel (DE) and the Institute for biochemistry and molecular biology at the University of Southern Denmark, Odense (DK). The contribution of the ERDF is €298,561;

– Creation of a university cross-border study course on biological oceanography: Bio-Ocean is a joint study programme in the FYN-K.E.R.N programme between Denmark and Germany in the sector of Biological Oceanography offering an interdisciplinary combination of lectures, seminars, practices. The programme covers Physical Oceanography, Chemical Oceanography, Biological Oceanography, Marine Geology, Experimental Design and Data Reporting and Cost-Benefit Analysis. During the first term students follow courses covering the basics of physical, chemical, biological and geological oceanography. In addition students follow elective courses relevant to biological oceanography. During the second term, at the University of Southern Denmark, the focus is on advanced biological oceanography and the management of natural resources and environmental economics. In the third and fourth terms students carry out independent project work in biological oceanography under the supervision of an academic advisor from Kiel and/or Odense. At the University of Southern Denmark in Odense, the students will attain a M.Sc. degree in Biology, specialized in Biological Oceanography. At the University of Kiel, this programme will lead to a Diploma degree. The lead partners are the Christian-Albrechts-Universität, Kiel (DE) and the Institute for biology at the University of Southern Denmark, Odense (DK). The contribution of the ERDF is €728,760.

– Harmonisation and upgrading of diagnostic and therapeutic strategies on osteoporosis. This project is developed in the framework of the cross-border co-operation programme between Denmark and Germany INTERREG IIIA Fyn-K.E.R.N. and comprises population-based patient studies and development and validation of a diagnosis instrument. The lead partners are Kiel Polytechnic (DE) and University Hospital of Odense (DK). The contribution of the ERDF is €267,056.

– Helsinki-Tallinn Science Twin City. Developed in the context of the cross-border co-operation programme between Finland and Estonia, the core concept of this project is to foster co-operation between players in the science park environment in the Helsinki (Uusimaa) and Tallinn (Harju) regions. Activities of the programme can be divided into three categories: 1) common curricula, graduate schools and research facilities; 2) exchange/mobility of undergraduate and graduate students and scientists; and 3) high-tech business development (e.g. networking, infrastructural development, start-up, growth and internationalisation phase programmes and other support measures, spin-off mechanisms, incubators, licensing and commercialisation of scientific research results etc.). In order to implement the 3rd item, an INTERREG IIIA Finland-Estonia project was run in 2002-2005. Three fields of science were addressed in the project. These were: biomedicine and biotechnology; ICT; and material sciences and new technologies. The scope of the programme can be expanded later as new relevant fields of science and the need to foster cooperation within these fields arise. Interest has already been shown in including areas such as environmental, ecological and social sciences and urban studies in the project. The part of the project financed by Interreg IIIA was coordinated by Culminatum Ltd Oy (FI). The contribution of the ERDF was €81,400.

– RETSA. The objective of the project developed in the context of the cross-border co-operation programme between France and Spain is the creation of a food safety network. This network will answer needs and questions at scientific, technical and industrial level in the field of food safety. It will enable the development, the testing and the evaluation of new methods, as well as the exchange and transfer of experience and know-how between participants. This will permit to maintain a level of monitoring and information on food safety which can answer the needs of interested parties, in particular public administrations and enterprises from the food sector. Another objective of this network is to create a virtual centre of competence on food safety: competences of all participants will gather in a single place, decentralised geographically but unified from the point of view of the potential user. This centre will have a sufficient critical mass to launch cooperative research programmes between the different partners within already existing European Programmes (FP6, Eureka, bilateral programmes,…) The lead partner is the Centro Tecnico de Conservas Vegetales - Laboratorio del Ebro (E). The contribution of the ERDF is €537.844,80.

– Utilisation of adult stem cells in cardiologic diseases by regenerative cell therapy. The underlying idea of this project, developed within the framework of the cross-border programme between France and Spain, is based on the following hypothesis: mother cells taken on adult tissues (muscle, marrow and fat) have the capacity to regenerate cardiac muscular tissue damaged by an Acute Myocardial Infarction and can also contribute to the heart's contractile function. Stem cells have to be differentiated in vivo or in vitro from cells having the same characteristics as cardiac tissues. The demonstration of the functional capacity of the mother cells requires the use of an adequate animal model. The lead partner is the University of Navarra (E). The contribution of the ERDF is €974.396.

– Repartir – "REseau de Prospective et d’Animation visant à Renforcer les pôles Technologiques, d’Innovation et de Recherche et organiser leur complémentarité dans le Sud-Ouest Européen". The objective of this project developed within the framework of the trans-national programme "South West Europe (SUDOE)" is to lead a future-orientated reflection enabling coherent and complementary policies in the field of research and innovation, taking into account regional specificities. As a first step, a mapping of excellence in research and technology transfer will be done for the "SUDOE" region. This will permit the partners to present perspectives for each regional scientific and technological centre as part of the European Research Area and to propose a strategy for each region, and for the "SUDOE" as a whole, on areas of emerging new competences. A pilot action will be developed in the field of biotechnology. This action will lead partners to elaborate and draft research programmes for each network and to answer European calls for tender. Partners of REPARTIR + will contribute to ensuring the follow-up of collaboration and set up a research and development observatory in the SUDOE region. The lead partner is the Réseau universitaire Toulouse Midi-Pyrénées (F).The contribution of the ERDF is €468.458,97.The network will be composed of the following participating regions:

(a) Cataluña : Biotechnology networks;

(b) País Vasco: Nano-materials networks;

(c) Midi-Pyrénées : Aeronautic network;

(d) Galicia and Aquitaine: Economical and societal working group aeronautics, nano-material and biotechnology.

– BioValley: Bio Valley is a tri-national project located between Alsace in France, South Baden in Germany and north-west Switzerland. It already received support during the INTERREG II programme (1997-1999), when support was used to identify the region's principal competences in biotechnology. The new project, supported through INTERREG III, has the objective of developing, on the basis of work undertaken during the INTERREG II period, a real profile as "biotech region" by determining areas of excellence and putting in place appropriate measures. Areas of activity include:

(a) Establishment of the BioValley profile (determination upper-Rhine areas of excellence in the field of biotechnology);

(b) Economic measures (creation of a network of biotech parks, transfer of technology between universities and enterprises);

(c) Communication activities towards scientists, business operators and the general public;

(d) Call for tenders programmes.

The aim is to reach, at the end of the INTERREG III project, self funding via a private structure. The lead partner is the Association Alsace Bio Valley (Illkirch). The contribution of the ERDF is €858.750 [48].

The European Territorial Co-operation Objective replaces the INTERREG III initiative for the period 2007-2013. It will continue to provide support for cross-border, trans-national and inter-regional co-operation, including in the area of biotechnology.

Action to be continued as such: the funding of a number of networking activities has facilitated the liaison between scientists and business, improving competitiveness

Action 9b - Biotechnology clusters

The implementation of action 9b should be refocused in order to identify and exploit the added value of specific cooperation actions between company clusters and bio-regions. Such actions could be supported through FP7 or the Competitiveness and Innovation framework Programme (CIP) [49]. While previous networks have largely focused on the exchange of best practise on regional development (i.e. of cluster management, incubator development, factors for attracting investment, etc), only a few strategic initiatives (such as the "ScanBalt Competence Region" [50], a project aimed at mapping competences within the ScanBalt region [51], identifying strengths and weaknesses, and developing a common strategy for improving overall competitiveness and attractiveness of the ScanBalt Network) exist which develop common strategies and activities within a network of bioregions/clusters with the objective of increasing overall competitiveness of the network. Another interesting initiative has been the creation by the BioValley region [52], supported by the cohesion policy's INTERREG II and III programmes (described further under action 9a above), of a One-Stop portal for the region which provides access to a large pool of Life Science-related jobs that range from research, marketing, management or communications [53]. The need for networking "people" such as young biotechnologists has also been recognised as important for ensuring the future competitiveness of Europe's biotech sector.

The role of biotechnology clusters remains important but action 9b should be re-focused to identify and exploit cooperation between bio-regions to increase competitiveness

Action 10 – Competitiveness monitoring

A contact network with Member States ministries and an Advisory Board in Competitiveness in Biotechnology Group have been created and are fully operational.

Action 10a has been fully achieved. The contact network with Member States ministries with responsibility for competitiveness in biotechnology was set up in 2003. The network has representatives from 20 Member States and meetings are organised at least twice per year. In 2006 the co-operation has intensified and four meetings have been held during the first semester. In preparation of the mid-term review of the Strategy on Life Sciences and Biotechnology and its Action Plan, the network has produced a set of concrete recommendations in four thematic fields: regulation, access to finance, plant science and the knowledge-based bio-economy, and communication with the public [54]: A summary of these recommendations is found in Annex III.

The contact network with Member States will continue to monitor the implementation of biotechnology regulation, the level of harmonisation at national level, and the effects of possible deficiencies.

Action 10b has been fully achieved. The Competitiveness in Biotechnology Advisory Group (CBAG) with industry and academia [55] was set up in 2003. It has delivered three reports in 2004, 2005 and 2006 with relevant policy advice on competitiveness issues that have served as input for the mid term review. The advisory group's reports were prepared for the use of the European Commission, but do not necessarily represent the Commission's official position. The 2006 report of the CBAG and its summary can be downloaded [56].

Action 10 has been fully achieved

Action 11 - Transparency in the administrative process for applicants

With the 2005 reform of the European Medicines Agency (EMEA), the drug development process has been simplified, facilitating the role of SMEs. Together with the recently published User Guide to European Regulation in Biotechnology, transparency in the way this area is regulated has been improved.

In the field of pharmaceuticals, action 11a has been fully achieved. The reform of EMEA (Regulation (EC) No 726/2004 and Regulation (EC) No 2049/2005) has meant a number of improvements:

– reinforced scientific advice as early as possible in the drug development process;

– an SME office to help SME applicants find their way more easily, and to provide administrative assistance such as translations;

– SMEs may also benefit from fee waivers and deferrals.

– In other fields of biotechnology, the Commission is in close contact with operators to help them with the notification procedures.

Action 11b has been fully achieved. The Commission has in collaboration with a consultant developed a User Guide to European Regulation in Biotechnology, which was finalised and published in 2006 [57]. It has been conceived to help companies identify routes to regulatory compliance for their products and processes. At the same time, it will help all EU citizens to improve their understanding of the way regulation balances the benefits, risks and ethical issues arising from biotechnology.

Action 11 has been fully achieved

Action 12 - Benchmarking of clusters and business incubators

Benchmarking clusters and business incubators have not met the interest that would make it worthwhile to go further with this action.

By contrast, a programme for benchmarking biotechnology policies has been started by the Commission. A first round of benchmarking of national policies took place in 2004 in close collaboration between the Commission and MS governments and was published in 2005. A second round is planned at a later stage to evaluate how far policies have evolved and what impact it has had on the biotech community.

Since 2002, new studies on the role and development of clusters have been made and improved our understanding of their importance. The action does not need to be pursued at the current time.

The benchmarking of clusters and business incubators in view of the current understanding and available studies does not seem necessary. Action 12 does not need to be pursued further

Action 13 - Societal scrutiny and dialogue

In the 2005 Eurobarometer survey on biotechnology [58], 52% of those polled indicated a belief that biotechnology will improve their quality of life. The Eurobarometer “Europeans and biotechnology in 2005” shows that most Europeans are in favour of medical applications of biotechnology when there are clear benefits for human health. They are also in favour of industrial applications, but they are still generally sceptical about agricultural biotech, and will continue to be so unless new crops and products are seen to have societal benefits. Confidence has increased in the European Union's regulation of biotechnology but there is no evidence that this has influenced the public's reported purchasing intentions, especially for GM foods. Overall, optimism about biotechnology's contribution to improving society has grown significantly since 1999. There is also support for research using stem cells, provided this is tightly regulated.

A structured framework for the dialogue with stakeholders to make the regulatory oversight of biotechnology more open and transparent is still only partially achieved. Ongoing efforts to reassure rigour of the scientific risk assessment in the protection of human health and the environment should continue as a high priority. More efforts are also needed to assess and demonstrate how biotechnology can contribute to addressing global challenges. Nonetheless, a substantial number of actions have been implemented by Commission services to achieve the objectives of action 13. There exists a recognised need for the establishment of international quantitative impact indicators for all aspects of life sciences and biotechnology and to conduct a systematic impact analysis on the benefits and risks of biotechnology in order to support a structured and evidence based societal dialogue and policy making process. A close collaboration between the Commission, Eurostat, Industry, Member States and the OECD is needed.

The Commission has set up the Pharmaceutical Forum, a senior platform which is designed to provide a broad political mandate to discuss and agree ways forward on key non-legislative issues that have an impact on European competitiveness and related health policies. Working groups set up under the Forum will treat three major, controversial and long-standing issues, namely pricing and reimbursement, relative effectiveness assessments and information to patients. The Pharmaceutical Forum is of strategic importance and the activity will continue. Depending on the outcome it may become possible to achieve common understanding at European level on several of the topics discussed.

The Commission has organised various scientific meetings and workshops [59] to raise awareness for the state of the art and existing challenges regarding measurements in life sciences and biotechnology. Particular topics such as reliability and comparability of bioanalytical measurement data, the evaluation of measurement uncertainties and their consideration for decision making processes as well as the full range of standardization and metrology for bioanalysis have been addressed. Measurements of biological molecules and other entities can still impose considerable challenges and international harmonisation is ongoing. The activities have to be continued at the various levels of the international technical measurement infrastructure and between scientists, industry and regulators.

In December 2003 the Commission organised the first stakeholder conference with the objective of exploring the effect of human perception on risk assessment and its significance and implications in promoting key scientific paradigms underlying regulatory oversight and governance. In particular, the conference addressed the issue of risk assessment and risk analysis, and how these processed could be improved.

Ever since, the European Commission has continued to take action to reassure the general public, stakeholders and Member States that Community decisions on GMOs are based on rigorous scientific assessments which deliver a high level of protection of both human health and the environment. To this end, the Commission has adopted a series of actions in its orientation debate of 12 April 2006. The Commission presented these actions to the Environment Council in June 2006 and Member States welcomed the Commission's proposal. The Commission will continue to work together with Member States EFSA, and stakeholders in the coming months with the objective of building greater consensus and transparency in this area of Community policy. Some steps have already been taken to ensure greater transparency in the risk assessment procedures, such as the recent public consultation organised by EFSA on GMO feeding trials [60]. However, more actions probably need to be undertaken to assess the current as well as the potential future benefits of agriculture biotechnology and therefore enhance society acceptance and confidence.

By Commission Decision 2004/613/EC of 6 August 2004, the Commission has created an advisory group on the food chain and animal and plant health. The advisory group comprises 36 members representing different economic sectors, consumers and animal welfare organisations. These stakeholder representatives are consulted on health and consumer protection work programmes and measures in the areas of food safety, labelling, human nutrition, animal health and welfare and plants and pesticides. If there was need, a focus group on biotechnology could be set up within this advisory group

In the field of Community research and development policies, the Commission has developed a number of activities in the field of governance, notably regarding the participation of civil society in decision making processes, the collection and use of expertise and scientific advice.

At programme level, Civil Society Organizations and NGOs are increasingly becoming members of the advisory groups for the implementation of the various thematic priorities under Research Framework Programmes. Actions have been taken to launch public consultations in relation to the preparation of the research priorities including under the thematic priority on Sustainable development [61].

At project level, initiatives have been taken to involve for example consumer and patient organisations in research projects from the very beginning of a new project, rather than at the final stage, for instance, in relation to the acceptance of new food products. Behavioural studies and food choice aspects have been incorporated particularly in Integrated Projects. Examples of this approach are those projects aimed at developing new food products for reducing the prevalence of chronic diseases or networks that started under the initiative of patient associations [62]. Furthermore, in drawing up the work programme for the final Food Quality and Safety Programme Call for Proposals, specific efforts have been made to include consumer interests in research projects by making consumer aspects a requirement in specified programme areas.

Specific projects regarding the process of governance were supported, addressing issues of scientific advice, risk governance and the participation of civil society, notably in the field of GMOs, stem cells and so forth [63].

As a conclusion, a continuation of the effort made by the European Union – and its Member States – in recent years to draw together the "innovation triangle" (science, society and the economy) remains a priority.

One of the main conclusions which can be drawn from current experience is the need to involve Civil Society Organisations early in the research process and on a permanent basis and not only launching individual actions in relation to the implementation of programmes or projects. The experience gained may also contribute to the development of a framework for dialogue as proposed under action 13a.

This could imply a more systematic involvement of Civil Society Organizations, NGO's and other interest groups, such as networks of young biotechnologists, in the implementation of the strategy and should be encouraged. This could include:

– The establishment of a Civil Society Organization forum to assist the Commission in the implementation of the strategy. Initial steps have already been taken through announcement of the creation of this new forum on the revised Biosociety and KBBE Website and the invitation to Civil Society Organization and others, including individuals, to register for further information and to become involved in the broad based debate on the future of life sciences (particularly in food, agriculture and biotechnology);

– A more systematic involvement of Civil Society Organization and NGOs in, for example, technology platforms, research projects or conferences at community as well as at national level to discuss amongst other things research agendas, to assess research findings and to make the regulatory oversights of biotechnology more open and transparent. For example Civil Society Organizations were co-organising a EC conference on Stem Cells and their Therapeutic Applications in 2005 and CSOs will be invited to take part in the forthcoming foresight conference to be held early 2007 to consider the future of food and the food industry in 2030;

– Promote initiatives lead by Civil Society Organisations e.g. organisation of conferences or support the outsourcing of research in relation to the activities of this typt of organisations, including the dissemination of results to the public. FP7 will support such activities along with other mechanisms;

– Encourage research institutions to support innovative governance experiences.

The need to undertake impact assessment studies as one of the tools to inform the public and structure the debate should be highlighted. The inclusion of sustainable consumption and production among the priorities of the Sustainable Development Strategy will require enhancing the consideration of impact assessment in relation to policy dialogue. There is a need to develop new and better assessment tools regarding the economic, social and environmental impact of biotechnology. These aspects will be addressed in FP7.

The Commission as well as many Member States have called for an engagement of scientists with the public, at different levels. However scientists and in particular young scientists are faced with a paradigm, since going out of the laboratory and the need to communicate more actively with society in the early stage of a scientific career is not being emphasised. If we do not target directly early stage researchers, it will be impossible to develop a future scientific community integrating public engagement and interaction within its structural values and public duties. There is a need to take into account non-scientific experiences, in particular communication and engagement with public.

Action 13 should continue to encourage societal debates on the benefits and risk of life sciences and biotechnology

Action 14 - Better integration of socio-economic and ethical issues

This action aiming at better integration of socio-economic and ethical issues has been successfully implemented in FP6 and it is the Commission intention to continue to apply these tools for governance of research under FP7 (2007-2013). This action should be refocused to better reflect the intention of the Commission to define and apply ethical framework and standards for FP7, so as to reinforce the ethical review as well as encourage the participation of ethicists, lawyers, patient organisations, farmers, animal welfare organizations, and other stakeholders in research projects thereby active engagement in public dialogue could be envisaged.

In order to ensure that fundamental ethical principles are respected and the ethical, legal, social and wider cultural aspects are taken into account at the earliest possible stage of Community–funded research in Life Sciences and Biotechnology, involving the general public to the greatest extent possible, the Commission has taken a number of actions, under FP6 including:

– Defining an ethical framework and ethical standards for FP6 [64];

– Reinforcement of the ethical review of project proposals that raise sensitive ethical issues or where ethical issues have not been proper