Life Sciences & Biotechnology for Europe

Transcription

1 Life Sciences & Biotechnology for Europe

2 Opportunities in life sciences and biotechnology Jointly edited and published by the European Commission and the European Patent Office. Editors: Michael H. Wappelhorst (EC) and Rainer Osterwalder (EPO). Photos: 3rd edition, April The European Commission, which is the executive arm of the European Union [EU], the European Patent Office [EPO] and the European Medicines Agency [EMEA] are working closely together to support the development of life sciences and biotechnology in Europe. In this role they present themselves as a one-stop shop for anybody who is interested in research and business opportunities in Europe. This includes joint presentations at international events. The European Union supports research and innovation in life sciences and biotechnology and offers opportunities for research, partnering and business in Europe. LEGAL NOTICE: Neither the European Commission nor any person acting on behalf of the Commission is responsible for the use which might be made of the following information. The views expressed in this publication are the sole responsibility of the author and do not necessarily reflect the views of the European Commission. A great deal of additional information on the European Union is available on the Internet. It can be accessed through the Europa server ( Cataloguing data can be found at the end of this publication. Luxembourg: Office for Official Publications of the European Communities, 2007 ISBN European Communities and European Patent Office, 2007 Reproduction is authorised provided the source is acknowledged. Europe and the European Union 4 8 European Patent Office 9 11 Joint Research Centre [JRC] 12 European Medicines Agency 13 European countries 15 More information 16

3 DOING BUSINESS IN EUROPE The European Union The European Union [EU] presently has 27 member states which represent close to 500 million people, making the EU the world s largest common market and leading exporter. Thirteen countries, the commonly known "Euro area" use the Euro as common currency - with a 15% share of world GDP in 2005, the euro area is the world s second largest economy after that of the United States. More info: The European Commission The European Commission is the executive arm of the European Union and largely responsible for managing the EU's common policies, such as research, agriculture, trade, development aid, etc. The Commission also manages the budget for these policies. More info: EU support for research in the life sciences Through the Seventh Research Framework Programme (FP7, ) the European Union annually provides about 1 billion in public funds for life sciences research. These funds are allocated mainly through competitive calls inviting proposals for collaborative R&D projects in a variety of areas like health research (including genomics), biotechnology, agriculture, fisheries and food. More info on thematic priorities: Health Research: Food, agriculture and fisheries, biotechnology: Facts and figures The European dedicated biotechnology industry directly employs people, mostly in SMEs. Employment in industries that use biotechnology products is many times higher. The industry is highly research intensive, with 44% of its employees involved in R&D activities. In 2004, the 2163 dedicated biotechnology companies spent 7.6 billion on R&D. The EU accounted for 34.8% of biotechnology patents filed at the European Patent Office in , compared to 41.1% for the US. According to a Eurobarometer survey in 2006, one in two Europeans believe that biotechnology will improve their quality of life. The survey "Europeans and Biotechnology" showed widespread support for medical and industrial applications of biotechnology, though there was a more negative position on GM foods (58% against, 42% in favour). The same survey showed that the EU is more trusted than national governments on issues of regulating biotechnology. Taking goods and services together, the EU and the USA account for the largest bilateral trade relationship in the world. The significant amount of bilateral trade and investment illustrates a high degree of interdependence of the two economies. Pharmaceuticals Europe produces more than 35.8% of the world s pharmaceutical output, worth some 161 billion, making it second manufacturing location after the US with 39.3%. Chemicals Europe is the world s largest producer of chemicals, with a turnover of around 580 billion accounting for more than one third of their production. Agrifood with a turnover close to 800 billion, Europe is the world s largest food producer. The US is the largest trade partner in this sector, importing 9 billion worth of food from the EU and being a large supplier of agricultural raw materials for the EU food and feed industries.

4 DOING BUSINESS WITH EUROPE DOING RESEARCH WITH EUROPE EU strategy on life sciences and biotechnology In a mid-term review of the EU Strategy on Life Sciences and Biotechnology for , the European Commission in 2007 proposed a refocus of actions to promote a competitive and sustainable European knowledge based bio-economy. Specific emphasis is put on five biotech-specific priority actions: promote research and market development for bio-based products, facilitate knowledge transfer and innovation from the science base to industry, encourage informed societal debates on the benefits and risk of life sciences and biotechnology, ensure a sustainable contribution of modern biotechnology to agriculture, improve the implementation of legislation. More info: and European Research Area - towards a European knowledge market The European Research Area [ERA] is the vision to make the most of Europe's knowledge potential. The EU's vision is to tap this potential by providing freedom for people, infrastructures, organisations, funding, knowledge circulation and global co-operation to operate effectively, securing knowledge firmly at the heart of society. Challenges are posed by underinvestment in and fragmentation of research and the growing globalisation of science & technology. To reach the ERA objectives significant resources are mobilised through multiannual research framework programmes. Although these R&D funds provided by the EU account for only around 5% of the overall public research funds in Europe, they are a major instrument to encourage R&D collaborations in Europe and beyond. European bio-economy Services 34% Agbio and Environmental 11% Biodiagnostics 18% More info: International R&D cooperation Organisations [companies, research institutions and researchers] from all over the world are welcome to participate in EU-funded research consortia with Europebased partners. Participation from industry [small and large companies] is highly encouraged. Human Healthcare 37% The EU member states link up their research activities with associated countries like Switzerland, Iceland, Norway, Turkey and Israel, as well as countries with science and technology [S&T] cooperation agreements with the EU, such as the US and Canada. Essentially, cooperation with European research teams is possibly for researchers from more than 100 countries in the world. Distribution of biotech companies by sector in Europe (Source: EuropaBio, 2006) More info: ERA-Link a network for EU researchers in the US ERA-Link is a networking tool for European researchers in the US. It provides information about research in Europe, European research policy, opportunities for research funding, for international collaboration and for trans-national mobility. The multidisciplinary network involves researchers at all stages of their careers and allows them to become well connected amongst themselves and in Europe, ensuring that they are recognized as an important resource for the European Research Area, whether they remain in the US or choose to return. More info:

5 DOING RESEARCH IN EUROPE The European Research Council The European Research Council (ERC) is the first pan-european funding body set up to support investigator-driven frontier research. The ERC, officially launched in 2007, complements other funding activities in Europe, such as those of the national research funding agencies, and is a flagship component of the 'Ideas' programme of the EU's Seventh Research Framework Programme (FP7). Being 'investigator-driven' in nature, the ERC approach allows researchers to identify new opportunities and directions for research. ERC grants, totalling an annual average of 1 billion until 2013, will be awarded through open competition to projects headed by young and established researchers, who are working in Europe irrespective of their country of origin. The sole criterion for selection is excellence. The aim is to recognise the best ideas, and retain and confer status and visibility to the brightest minds in Europe, while also attracting talent from abroad. More info: Want a scientific career in Europe? The 'People' programme, the 4.7 billion portion of the EU's Seventh Research Framework Programme (FP7) offers individuals the opportunity to continue to pursue a career in research. European researchers are encouraged to stay in Europe whilst at the same time the best researchers in the world are attracted by research excellence and infrastructures in the European Research Area (ERA). The 'People' programme builds on the positive experiences of the well-established 'Marie Curie' actions. The mobility of researchers is not only key to the career development of the researcher but also vital to the sharing and transfer of knowledge between countries and sectors. Many of the fellowships are open to researchers from anywhere in the world - wishing to continue their research career in Europe. More info: THE EUROPEAN PATENT OFFICE The task of the EPO is to grant European patents for inventions in all fields of technology. The EPO has its headquarters in Munich and offices in Berlin, the Netherlands, Austria and Belgium. With its workforce of nearly 6 500, the EPO is also one of the largest international organisations. Reaching a market of 540 million people The EPO is the executive body of the European Patent Organisation. It operates on the basis of the European Patent Convention [EPC] which has been ratified by the 32 member states of the Organisation. The Convention provides the legal basis for all activities of the Office and establishes standards and rules governing the treatment of patents granted by the EPO. It makes it possible to obtain patent protection in several or all member states depending on the choice made by the applicant by filing a single patent application with the EPO in English, French or German. As the European Union and European Patent Organisation are largely identical in terms of member states, it is possible to obtain EU-wide patent protection with the help of a European patent, although EU patents as such do not yet exist and the EPO is not an EU authority. A number of other European countries also recognise European patents for their territory. As a result, the European patent now covers a market of more than 540 million inhabitants. JP 16,4% *Others 9,4% DE 18,4% FR 5,9% NL 5,4% CH 4,0% Europe 48,5% US 25,7% JP 16,4% Others 9,4% US 25,7% IT 3,1% GB 3,5% 8,2% AT, BE, BG, C, CZ, DK, EE, ES, FI, GR, HU, IE, IS, LI, LT, LU, LV, MC, PL, PT, RO, SE, SI, SK, TR Patent applications submitted to the EPO by region in 2006 (total number: )

6 Since its creation in 1977, the EPO has received more than 2 million patent applications and granted over European patents. Moreover, the Office has established itself as the leading authority for international procedures under the Patent Cooperation Treaty that makes it possible to file for patent protection in more than 100 countries on the basis of a single patent application. With more than 56 million documents, the EPO s patent databases are among the largest in the world. They can be accessed on the Internet using the Office s free Espacenet server: Validity of patents As in other patent systems, the grant of a European patent does not confer a positive right to use the invention without complying with all applicable rules of the legal system. The EPO has no regulatory competence, and permission to commercialise patented inventions may have to be obtained from the respective national and European authorities. Generally, the term of a European patent is limited to 20 years from the date of first filing [priority date]. More info: High quality patents The EPO examines European patent applications originating from countries all over the world in all fields of technology, including biotechnology and life sciences. Medical or veterinary science; hygiene Biochemistry; genetic engineering In carrying out its task the EPO strictly applies the European Patent Convention and other relevant European law, such as the EU s Directive on the legal protection of biotechnological inventions. European patents are granted only after a thorough examination procedure, carried out by three patent examiners specialised in the respective technology. This ensures high quality and legal certainty standards for European patents. The EPC also provides legal procedures for centrally opposing European patents within nine months from grant. Moreover, all decisions reached by the EPO and its instances can be challenged by an appeal before the EPO s independent judiciary, the Boards of Appeal. Disputes concerning the validity and infringement of a European patent are subject to national law, and the final decision rests with national courts. EU-27 Biotech and life sciences: number of European patent applications filed at the EPO in 2006 by region of origin 10 11

7 JOINT RESEARCH CENTRE The European Commission s Joint Research Centre [JRC] provides customer-driven scientific and technical support for the conception, development, implementation and monitoring of EU policies. It functions as a reference centre of sciences and technology for the European Union. Close to the policy-making process it serves the common interest of the Member States, while being independent of special interests, whether private or national. The JRC contributes to the implementation of the EU Strategy on Life Sciences and Biotechnology. A comprehensive study on the consequences, opportunities and challenges of modern biotechnology for Europe and its contributions to the achievement of major EU policy goals is available at Further activities in the field of biotechnology cover the following areas: Food, Feed and Agriculture The JRC is running the Community Reference Laboratory [CRL] for genetically modified [GM] food and feed which is involved in the authorisation of GM products and the detection of adventitious GM in non-gm material. Further, the JRC provides quality assurance tools for the detection, identification and quantification of GMOs. The JRC supports EU policies on the coexistence of GM with non-gm crops and carries out studies on emerging biotechnological applications in food production. Nanotechnology The JRC develops biological/non-biological interfaces and new sensing techniques for applications in environment and health. Supporting EU policies on nanotoxicity, the JRC develops, validates and harmonises methods for evaluating the potential toxicity of nanoparticles as well as for the characterisation and toxicity testing of nanoparticles. In addition, it develops quality control tools to increase the reliability in measurements at the nanoscale and of nanomaterials. EUROPEAN MEDICINES AGENC (EMEA) The European Medicines Agency contributes to the protection of public and animal health by assessing the quality, safety and efficacy of human and veterinary medicines in accordance with the centralised procedure a European Union procedure that allows a medicinal product to be marketed in all EU Member States with a single authorisation, granted by the European Commission on the recommendation of the EMEA. The EMEA works closely with the national regulatory authorities for human and veterinary medicines of the 30 European Economic Area countries (EU-27, Iceland, Liechtenstein and Norway), their 4,000+ experts, and with the institutions and bodies of the EU, in what is referred to as the European medicines network. The scientific opinions of the EMEA are prepared by its scientific committees: the Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP), the Committee for Orphan Medicinal Products (COMP), the Committee on Herbal Medicinal Products (HMPC) and, from 2007, the Paediatric Committee (PDCO). The Agency also cooperates closely with international partners, reinforcing the EU contribution to global harmonisation of regulatory standards for medicines. European Medicines Agency [EMEA] 7 Westferry Circus, London E14 4HB, United Kingdom Tel. (44 20) Fax (44 20) info@emea.europa.eu Health-related aspects Promoting the EU-wide coordination of efforts to ensure the highest quality possible of genome-based diagnostic technologies, the JRC gives scientific advice for policy actions in this area and delivers quality assurance tools for bioanalysis. More info:

8 European countries European Union European Patent Organisation Albania 2 Austria Belgium Bosnia-Herzegovina 2 Bulgaria Croatia 1 2 Cyprus Czech Republic Denmark Estonia Finland Former ugoslav Rep. of Macedonia 1 2 France Germany Greece Hungary Iceland Ireland Italy Latvia Liechtenstein Lithuania Luxembourg Malta Monaco Montenegro 2 Netherlands European Commission, European Patent Office 1 candidate for the European Union 2 extension state of the European Patent Organisation Poland Portugal Romania Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey United Kingdom 1 2 overview Life Sciences & Biotechnology for Europe 15 Luxembourg: Office for Official Publications of the European Communities pp x 25.0 cm ISBN

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