Study in Support of Impact Assessment Work on Blue Biotechnology
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Study in support of Impact Assessment work on Blue Biotechnology Final Report FWC MARE/2012/06 – SC C1/2013/03 Client: DG Maritime Affairs and Fisheries London/Berlin/Brussels/Rotterdam, 8 April 2014 Client: DG Maritime Affairs and Fisheries London/Berlin/Brussels/Rotterdam, 8 April 2014 Study in support of Impact Assessment work on Blue Biotechnology About Ecorys and Consortium Partners Consortium Lead Partner ECORYS Nederland BV P.O. Box 4175 3006 AD Rotterdam The Netherlands T +31 (0)10 453 88 00 F +31 (0)10 453 07 68 E [email protected] Registration no. 24316726 www.ecorys.com Study in support of Impact Assessment work on Blue Biotechnology Table of Content Executive Summary i 1 Introduction and policy context 1 1.1 Background and Objectives 1 1.2 Definition of Blue Biotechnology sector 1 1.2.1 Definition of marine biotechnology 1 1.2.2 Defining the Blue Biotechnology sector 2 1.3 Policy context 3 2 State of play: Importance of Blue Biotechnology 5 2.1 Value chain of Blue Biotechnology 5 2.1.1 Discovery, bioprospecting and R&D- the blue components of the value chain 6 2.1.2 Closing the marine biotechnology loop: the ‘blue’ application of marine biotechnology' 7 2.2 Overall size and structure of the Blue Biotechnology sector 7 2.2.1 Size 7 2.2.2 Structure 8 2.3 Global settings of Blue Biotechnology 9 2.4 Blue Biotechnology within the wider biotechnology landscape 10 2.5 Conclusions 10 3 EU-level problem analysis 13 3.1 Sector review 13 3.1.1 Overview of sub-sectors 13 3.1.2 Potential product areas in research and development 14 3.1.3 Landscape of Blue Biotechnology infrastructures 17 3.1.4 Socio-economic performance 19 3.1.5 The role of SMEs 27 3.1.6 Products and services already in use 29 3.1.7 Drivers and barriers in the Blue Biotechnology sector 33 3.1.8 Stakeholder Workshop 40 3.2 Network, cluster and policy analysis 43 3.2.1 FP6, FP7 and Horizon 2020 43 3.2.2 National, regional and European clusters, initiatives and networks 46 3.2.3 National policies in Europe 48 3.3 Review of patent profiling 50 3.3.1 Positioning of Blue Biotechnology sector vis-à-vis other sectors 50 3.3.2 Global perspectives 52 3.4 Regulatory Review 53 3.5 Conclusions 55 4 Objectives and policy options 59 4.1 Revisiting the barriers and problems 59 4.2 Overview of objectives 62 4.3 Specific objective 1: Enhance cooperation between research, SMEs and upscale businesses at an EU level 65 Study in support of Impact Assessment work on Blue Biotechnology 4.3.1 Preliminary analysis of objective 1 65 4.3.2 Overview of possible policy actions 65 4.4 Objective 2: Promote integration of knowledge and exploratory infrastructure 66 4.4.1 Preliminary analysis of objective 2 66 4.4.2 Overview of possible policy actions 66 4.5 Specific objective 3: Facilitate access to finance for second and third rounds of product development 66 4.5.1 Preliminary analysis of objective 3 66 4.5.2 Overview of possible policy actions 67 4.6 Specific objective 4: Improve clarity and completeness of legal framework 67 4.6.1 Preliminary analysis of objective 4 67 4.6.2 Overview of possible policy actions 68 4.7 Development of policy options 68 4.7.1 Policy option 1: No additional action 70 4.7.2 Policy option 2: Facilitating and promoting (soft policy measure) 70 4.7.3 Policy option 3: Mainstreaming Blue Biotechnology 71 4.7.4 Policy option 4: Formal policy measures 72 5 Impact Assessment 73 5.1 Inventory of relevant economic, social and environmental impacts 73 5.2 Assessment of impacts by measure 74 5.3 Substantiation of impacts by policy option 77 5.3.1 Impacts of policy option 2 77 5.3.2 Impacts of policy option 3 79 5.3.3 Impacts of policy option 4 79 5.4 Comparison of options 81 6 Conclusions 85 6.1 Conclusions 85 6.2 Monitoring and evaluation 86 Annexes: Supporting Information 89 Annex 1: Events and policy documents 89 Annex 2: Towards a value of the Blue Biotechnology sector 91 Annex 3: Stakeholder Database Analysis 94 Annex 4: U.S. National Algal Biofuels Technology Roadmap 99 Annex 5: Patent Profiling – Methodology and detailed results 102 Annex 6: Sub-sector reviews 120 Annex 7: Inventory of Marine Research Infrastructures 164 Annex 8: Sub-sector specific barriers 171 Annex 9: Analysis of the EU’s public consultation on Blue Biotechnology 174 Study in support of Impact Assessment work on Blue Biotechnology Annex 10: EU Framework Programmes for Research 181 Annex 11: National initiatives and clusters 183 Annex 12: EU and regional initiatives and networks 184 Annex 13: Stakeholder Workshop 193 Annex 14: Regulatory Review 195 Study in support of Impact Assessment work on Blue Biotechnology Executive Summary Policy Context There is currently no overarching Blue Biotechnology policy or strategy in Europe as a whole although Ireland, Denmark and Norway already have national policies in place. A number of strategic documents have been published as an outcome of science policy and research initiatives which have been implemented over the last decade or so. These have laid the foundations for a future vision and strategy for Blue Biotechnology across Europe. This activity has provided Europe with a future direction for Blue Biotechnology which addresses coordination and collaboration within Europe, identified research priorities, defined common interests within Europe, and highlighted the opportunities and potential for marine biotechnology as well as identifying some challenges to the growth of a Blue Biotechnology sector. The European Commission has acknowledged the potential of Blue Biotechnology in Europe through its Communication on Blue Growth1 and European Bioeconomy Strategy2, both of which identify Blue Biotechnology as a sector which has the potential to contribute to the bioeconomy and economic growth in general. Furthermore, EU research policy has been responsive to the growing awareness of the importance of Blue Biotechnology: the EU has funded, and will continue to fund, key research into marine biotechnology through its Framework Programmes for Research: FP6, FP7 and Horizon 2020. The EU’s new Horizon 2020 strategy and support programme3 specifically mentions Blue Biotech and marine biomass as contributors to the economy of the future. There have been major projects under FP6 and FP7 that have been focused on science policy, coordination, infrastructures and support of marine biotechnology, the outcomes of which provide key contributions to developing a European strategy. This study was conducted in support of the development of potential policy options for the EU and a possible impact assessment for marine or Blue Biotechnology as it can be termed in the context of furthering the aims of Blue Growth. To this end, a review of the status of Blue Biotechnology within the EU has been conducted along with the construction of a database of stakeholders in Blue Biotechnology and a patent profiling across the field. Furthermore, a stakeholder workshop has been held in order to obtain direct inputs from participants regarding opportunities and challenges of the sector. Additional views have been obtained from of the EU public consultation on the initiative. State of Play: Importance of Blue Biotechnology The Blue Biotechnology sector is diverse and encompasses a number of sub-sectors in which marine biotechnology applications are used. There are overlaps between the Blue Biotechnology and other biotechnology sectors and industries. However, there is a defining and unique characteristic of the Blue Biotechnology sector and that is its use of resources of marine origin. Processes and actions specific to this help define it and allow it to be distinguished from other biotechnology sectors. 1 European Commission, 2012, Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Blue Growth: Opportunities for marine and maritime sustainable growth, COM (2012) 494 final 2 European Commission, 2012, Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Innovating for Sustainable Growth: A Bioeconomy for Europe, COM (2012) 60 final 3 European Commission, Horizon 2020 Work Programme 2014-2015 in the area of Food security, sustainable agriculture and forestry, marine and maritime and inland water research and the bioeconomy, Important notice, http://ec.europa.eu/programmes/horizon2020/h2020-sections Study in support of Impact Assessment work on Blue Biotechnology i Due to the lack of a clear definition and statistical delineation of the Blue Biotechnology sector, it is difficult to determine the economic value and the employment it creates. However, an extrapolation from the whole EU bio-economic sector, based on a conservative estimate that marine biotechnology accounts for 2-5% of the sector as a whole, leads to an annual turnover in the range of € 302 – 754 million. The annual growth rate of the EU Blue Biotechnology sector revolves around 4-5%, somewhat below that of biotechnology as a whole (6-8%). Based on the stakeholder database developed in the context of this project, overall employment is currently expected to be in the range of 11,500-40,000 people employed – with productivity ratio’s leaning towards the lower end of the boundary. The importance of these employment data is above all derived from the fact that these tend to be high-end jobs which are the product of considerable public investment in education and training. Blue Biotechnology products pass along a value chain with the value and potential return from the product increasing as it becomes transformed by biotechnological techniques (Figure 1).