MECHANISMS TO



                                                                            07
                          ...
Spanish Biotechnology:

Economic Impact,
Trend and Perspectives
The main aims of this document are: firstly, to disseminate
the important role to be played by biotechnology in the improv...
SPANISH BIOTECHNOLOGY:
ECONOMIC IMPACT,
TREND AND PERSPECTIVES


Coordination and Writing:


Fernando Garcés Toledano, Jav...
© Fundación Española para el Desarrollo
de la Investigación en Genómica
y Proteómica (Spanish Foundation
for the Developme...
KEY POINTS
                    SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES




             Key Issues ...
P R E FA C E
               The European Union has recently relaunched its commitment to innovation through
              ...
CONTENTS
                SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES




           1. THE CONTEXT AND ...
CONTEXT   1. The Context and Global
             Impact of Biotechnology
          Throughout the history of mankind, soci...
SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES



It’s not just the genetic contents of crops and animals ...
CONTEXT



Recombinant human insulin was the first product obtained
with modern biotechnology. It has a market value of 3,...
SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES



O Custom-made Medicine: studying and exploiting the gene...
CONTEXT



O New Drugs and Vaccines: biotechnology enables us to advance in the knowledge of molecular and
  genetic proce...
SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES



                      THE BUSINESS RELEVANCE OF BIOTECHN...
SITUATION   2. The Situation of Biotechnology
               in Spain

            The current situation and trend of biot...
SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES


                                                         ...
SITUATION



                         BIOTECHNOLOGY IN SPAIN: TECHNOLOGY INDICATORS

                                     ...
SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES



Although royalties and other payments for               ...
SITUATION



    Public subsidies for biotechnology, whether from the Ministry of Education and Science, the Ministry of
 ...
SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES



        Distribution of Public Biotechnology            ...
SITUATION



  With respect to venture capital, the huge gap between biotechnology venture capital in Europe and in the
  ...
SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES



Biotechnology in Spain: Business Indicators

In order to...
SITUATION



Thanks to this classification, we know in which                    Distribution by Autonomous Community
conte...
SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES



                           R&D Investment in Fully      ...
SITUATION



It is very difficult to tell what percentage of the turnover and investment of partly devoted companies
corre...
SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES



Biotechnology in Spain: Perception Indicators



Spanish...
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
Spanish Biotechnology: Economic Impact, Trend and Perspectives
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Spanish Biotechnology: Economic Impact, Trend and Perspectives

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Spanish Biotechnology: Economic Impact, Trend and Perspectives

  1. 1. MECHANISMS TO 07 BENCHMARKING ENCOURAGE PRIVATE PARTICIPATION IN BIOTECHNOLOGY RDI: INTERNATIONAL ANALYSES AND COMPARISONS 09 OF INNOVATION AND BIOTECHNOLOGY SUPPORT POLICIES VENTURE CAPITAL 04 PROGRAMMES 06 POLICIES AND BIOTECHNOLOGY AND ORGANISATIONS IN CHARGE OF TECHNOLOGICAL TRANSFER AND BIOTECHNOLOGY KNOWLEDGE: 08 TO ENCOURAGE THE CREATION AND CONSOLIDATION OF BIOTECHNOLOGY COMPANIES: INTERNATIONAL INTERNATIONAL ANALYSES ANALYSES AND COMPARISONS AND COMPARISONS BIOTECHNOLOGY 03 SCIENCE PARK CULTURE IN SPAIN 05 BENCHMARKING STUDY ON 01 ECONOMIC BIOTECHNOLOGY IN THE SPANISH PUBLIC R&D SYSTEM. TECHNOLOGY TRANSFER AND BASIC ACTIVITY 02 PERSPECTIVES IN SPAIN INDICATORS SPANISH BIOTECHNOLOGY: TREND AND PERSPECTIVES ECONOMIC IMPACT,
  2. 2. Spanish Biotechnology: Economic Impact, Trend and Perspectives
  3. 3. The main aims of this document are: firstly, to disseminate the important role to be played by biotechnology in the improvement of both the competitiveness of Spanish economy and healthcare in our society and, secondly, to strategically contribute to the establishment of a future public initiative, which will make an appropriate development of this new technology in Spain possible.
  4. 4. SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES Coordination and Writing: Fernando Garcés Toledano, Javier Montero Plata and Miguel Vega García (GENOMA ESPAÑA) Collaborators: Armando Albert and Luis Plaza (Centre for Scientific Information and Documentation, CINDOC) - Higher Council of Scientific Research, CSIC) • STUDY ON BIOTECHNOLOGY IN THE SPANISH PUBLIC R&D SYSTEM TECHNOLOGY TRANSFER AND BASIC ACTIVITY INDICATORS Antonio Pulido, Julián Pérez, Milagros Dones, Juan José Méndez (Economic Forecasting Centre, CEPREDE) and Javier Montero (GENOMA ESPAÑA) • ECONOMIC PERSPECTIVES IN SPAIN Miguel Ángel Quintanilla, Modesto Escobar and Marcelo Sabbatini (SALAMANCA UNIVERSITY) and Mercedes Escribano (GENOMA ESPAÑA) • BIOTECHNOLOGY CULTURE IN SPAIN Nieves Sala and Lucía Reinoso (GENOMA ESPAÑA) • VENTURE CAPITAL AND BIOTECHNOLOGY Background Documents: In addition to all the literature reviewed, the following people were asked to make contributions to other important issues: (Navarra University Business School, IESE) Joan Roure and Pere Condom (BARCELONA SCIENCE PARK) Màrius Rubiralta and Montserrat Vendrell • SCIENCE PARK BENCHMARKING (INNOVATEC) Erika Sela and Joaquín Guinea • PROGRAMMES AND ORGANISATIONS IN CHARGE OF TECHNOLOGICAL TRANSFER AND BIOTECHNOLOGY KNOWLEDGE: INTERNATIONAL ANALYSES AND COMPARISONS (CONSULTRANS) José Ignacio Cases, Carlos Contreras, Jorge Ramos, María Izaguirre, Begoña Blanco and Virginia Hernando • MECHANISMS TO ENCOURAGE PRIVATE PARTICIPATION IN BIOTECHNOLOGY RDI: INTERNATIONAL ANALYSES AND COMPARISONS (EUROPAINNOVA) Rosa Mª Druguet, Teresa Puerta and Sergi Aulinas • POLICIES TO ENCOURAGE THE CREATION AND CONSOLIDATION OF BIOTECHNOLOGY COMPANIES: INTERNATIONAL ANALYSES AND COMPARISONS (IESE) Joan Roure and Pere Condom • BENCHMARKING OF INNOVATION AND BIOTECHNOLOGY SUPPORT POLICIES
  5. 5. © Fundación Española para el Desarrollo de la Investigación en Genómica y Proteómica (Spanish Foundation for the Development of Genomic and Proteomic Research, Genoma España) Editing: Silvia Enríquez Encinas (Genoma España) Referencia: GEN-ES05005 Fecha: June 2005 Legal Depository: M-43419-2005 ISBN: 84-609-6395-0 Design and Production: Spainfo, S.A.
  6. 6. KEY POINTS SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES Key Issues within the Document • The major assets of Spanish biotechnology are highly qualified scientists and a growing amount of public and private R&D investments. These two resources constitute a solid pillar to develop a productive biotechnology sector in Spain. In addition, it is worth noting that Spanish public investment in Biotechnology is reaching the levels of other European countries’ public investment in relation to population and GDP. • As far as biotechnology knowledge production is concerned, Spain is internationally competitive (4% of the world’s publications). The production of applications and technologies, however, is clearly unsatisfactory (0.16% of European patents granted). • Public subsidies to Spanish biotechnology for R&D projects and infrastructure grew significantly (22.6%) during 2000-2004. Business investment in biotechnology R&D for the same period increased at an average rate of 32.3%. • Spanish biotechnology is growing four times faster than the EU-15 average. However, its current relative size is half that of the EU-15 average, and around a quarter of the United States’. • Capital venture investment in Spanish productive biotechnology is almost non-existent. Investors argue that there are no mature projects for them to support. • At the current growth rates, Spanish biotechnology will reach European levels in 20 years’ time, and will need over 30 years to catch up with the that of the US. In reality, this is unlikely to happen. • From the economic point of view, Spanish biotechnology represents 0.4% of Spain’s GDP. Its effects, however, spread to other sectors representing over 20% of the country’s GDP. • The direct and indirect turnover and employment induced by Spanish biotechnology in 2004 are estimated at around 4,000 million euros and 36,000 people, respectively. • Assuming current annual growth rates, around 25% for R&D investments and 20% for direct employment, are maintained, economic forecasts suggest that in 2010 Spanish biotechnology could have a direct, indirect and induced economic relevance of 1.6% of GDP, affecting 100,000 employees. However, attaining these goals will require an adequate private and public investment policy and strategy. 7
  7. 7. P R E FA C E The European Union has recently relaunched its commitment to innovation through the Lisbon Strategy, whose goals are the allocation of 3% of GDP to R&D investment and a business funding figure of 66%. Spain is still considerably behind in this matter, with only 1.05% of GDP being invested in R&D (approximately half the EU-15 average) and business funding at just over 48% of total R&D investment. This makes it necessary to give a definite response to close the technology gap between Spain and Europe. On 23rd June 2005, the President of the Spanish Government presented the INGENIO 2010 initiative in line with the Lisbon Declaration and its reformist aims. This has become an international point of reference of RDI policy support. The new initiative is an opportunity to reinforce the growth of emerging technology sectors such as biotechnology, which, together with communication and information technologies, represents one of the most important commitments to technology made by the most advanced economies around us. Knowledge relating to biology and technologies developed in support of it, in particular biotechnology, is enabling us to achieve new levels of social well-being and economic competitiveness. The discoveries in this field are undoubtedly responsible for the current conceptions relating to food and medicine, and warrant new applications in other branches of science in which we must be at the forefront. The present report presented by the Genoma Foundation plays an important role in summarising and giving a systematic approach to the current situation and evolution of the Spanish biotechnology sector, comprising everything from the role and contribution of researchers to that of companies, including the financial aspects. Thanks to the report, we know that Spain has an excellent starting position in research fields, which are essential for taking advantage of the opportunities made possible by biotechnology. However, only a small portion of the knowledge generated is being turned into economic wealth by the business network. Part of the problem may reside in the lack of sufficient technology transfer and public-private cooperation. This is one of the main concerns of INGENIO 2010, and specifically of its CENIT programme, which will undoubtedly lead to a better use of the knowledge generated by us and to developing the biotechnology business sector. To help us achieve our goal, we have the Genoma Foundation's valuable contribution, of which this report is only a small (yet very significant) sample. Mr. Miguel Sebastián Director of the Presidential Economic Office 8
  8. 8. CONTENTS SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES 1. THE CONTEXT AND GLOBAL IMPACT OF BIOTECHNOLOGY 10 2. THE SITUATION OF BIOTECHNOLOGY IN SPAIN 16 3. INTERNATIONAL BIOTECHNOLOGY COMPARISONS 28 4. MACROECONOMIC RELEVANCE AND FORECASTS FOR THE FUTURE OF BIOTECHNOLOGY IN SPAIN 35 5. INTERNATIONAL MEASURES TO ENCOURAGE PRODUCTIVE BIOTECHNOLOGY 39 6. THE CHALLENGES OF BIOTECHNOLOGY IN SPAIN 49 9
  9. 9. CONTEXT 1. The Context and Global Impact of Biotechnology Throughout the history of mankind, society has gradually acquired significant knowledge and has tackled amazing challenges. All this has enabled considerable improvement in the quality of life. Suffice it to say that we have doubled our life expectancy in the last 100 years. Some of the challenges overcome by civilisations, some of which were seriously traumatic experiences at the time, include, among others, poverty and epidemics, both of which still mercilessly affect what we commonly refer to as the developing world (for more information, see The State of Food Security in the World 2004-FAO1). Humans in the biological processes of animal and plant life as we know have undoubtedly helped overcome many challenges of the past. Thus, the domestication of plant and animal species (genetic level alterations) as a result of the selection process started by man thousands of years ago was fundamental to the setting up of the first societies, through the generation of a continuous supply of food, which is undoubtedly the first pillar for the establishment of any society. “Our civilisation was born almost ten thousand years ago at the foothills of the Karacadag mountains in southeast Turkey, between the Tigris and the Euphrates rivers, as a result of the guided modification of the DNA of wheat… domestication consisted of extensive DNA alterations, which pushed their information contents [genes] against nature, from wild to domestic, from toxic to harmless, from independent life to fully man-dependent life.”2 Year 10000 BC Near East: domestication of the first cultivated plants (cereals, peas, lentils) and animals (sheep, goats). 1000 BC - 1000 AD Farming of irrigated rice in the valleys and deltas of China, India and Southeast Asia. Year 1800 First creation of wheat variants, ovine cattle selection in Europe, and new fruit varieties. Year 1987 Farming of first transgenic plants: insect-resistant tomatoes in the USA. 1 http://www.fao.org/documents/show—cdr.asp?url—file=/docrep/007/y5650s/y5650s00.htm 2 Considerations regarding plant genetic engineering. Dr Pilar Carbonero Zaduegui. Conference at the Spanish Academy of Engineering (Academia de Ingeniería de España). 10
  10. 10. SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES It’s not just the genetic contents of crops and animals that we have modified for husbandry purposes throughout our history but we have also genetically manipulated other microorganisms, specifically those that pose a threat to humans. Thus, for example, the ancestral knowledge of immunisation against the terrible infectious-contagious disease Poliomyelitis in Imperial China, where they took dead blood cells and fluids from an infected person’s pustule and injected it into the person to be immunised, inspired the development of Polio vaccines for decades. In 1953, just over 50 years ago, Dr. Salk eventually developed the first antipolio vaccine having isolated the three serotypes of the virus responsible for this “old pandemic.” The poliomyelitis virus enters the organism through the respiratory track and destroys the nerve cells, rapidly reproducing itself inside. The infection can result in permanent paralysis. With their knowledge, effort and experience past generations have shown and paved the way for us to manage nature when it challenges society in general and each of us in particular. Just as intervening in the biological processes of life allowed us to successfully handle some of these challenges in the past, we will use the same tools, now and in the future, but with a much more advanced and precise knowledge. Modern societies in developed countries such as Spain are facing new very important challenges such as fighting cancer and other degenerative or autoimmune diseases, sustainable development, economic productivity, health care quality, the search for renewable energies and the protection of nature. Many of these issues can and must be fully or partly resolved, just like we solved poliomyelitis and the feeding of society (for example), i.e. by intervening in the processes of life using what is known as modern biotechnology. Some of the first and most important applications of modern biotechnology, which began in the 1950s and 1960s following the double helix structure of DNA and the links between genetic inheritance and cells functions, will be very important for the treatment of diseases. Thus, for example, human insulin was the first drug produced by genetic recombination to be approved by the FDA. It considerably increased the quality of life and life expectancy of millions of diabetics worldwide.3 3 Food and Drug Administration (FDA): the United States agency that assesses and approves food and drugs. 11
  11. 11. CONTEXT Recombinant human insulin was the first product obtained with modern biotechnology. It has a market value of 3,000 million euros per year, and increases the quality of life and life expectancy of 5.3 Type I Diabetes sufferers. Recombinant insulin is the most advanced example of modern biotechnology. A long list of biotech products and services have been developed and marketed in the last two decades with the aim of improving health assistance and the financial competitiveness of certain production sectors. Some of the main applications of biotechnology and, by extension its main markets, are already transforming medicine, agriculture and industrial processes, among other things. O Regenerative Therapy: stem cells—whether embryonic or from the patient—enable damaged organs and tissues to be regenerated. • Current market value: over 3,000 million dollars. • There are 180 firms working in this field of therapy in the United States alone. • In 2004, the American Food and Drug Administration (FDA) approved the first clinical test using cells taken from the patient’s bone marrow for heart regeneration. • The National Ethics Committee is key to ensuring the responsible progress of stem cell research. O Genetic Improvement of Plants and Animals: traditional programmes for genetic selection and improvement of crops and cattle species are already benefiting from all the knowledge and tools created by biotechnology. • The vast majority of new crop and cattle species varieties are developed with biotechnological techniques, specifically genetic and molecular marker-assisted selection. • In 2001,4 the use of plants and crops to produce drugs will be worth 2,200 million dollars in the United States alone. • Genetic sequencing programmes and consortiums enable the design of genetic maps, which help increase the quality and resistance of agricultural production and products. • The first transgenic plants, developed to be resistant to chemical herbicides, have in no way contributed to spread the standpoint that biotechnology makes it possible to advance the sustainability of development of society. • Genetically modified crops generate a turnover of 44,000 million dollars. 4 Frost & Sullivan. Strategic Analysis of the World Plant Molecular Farming Market. 12
  12. 12. SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES O Custom-made Medicine: studying and exploiting the genetic differences between patients makes it possible to adapt the type of therapeutic treatment to increase its effectiveness and reduce its side effects. • Pharmacogenomics makes it possible to save costs in the development of new drugs and to adapt the therapy to each patient.5 • Genetic and molecular tests generated 1,000 million dollars in sales in 2001, with an annual growth of 30% to 50%.6 • The American Food and Drug Administration (FDA) has issued recommendations for the conducting of pharmacogenomic studies by pharmaceutical companies.7 • The genetic data must be collected and used under strict confidentiality protocols. O Food, Industry and Energy Bioprocesses: molecular biotech knowledge enables us to develop tools and applications to obtain high added value food ingredients, chemical compounds, materials and fuel. • According to OECD estimates, by 2010, one fifth of chemical production could be transferred to industrial biotechnology, and 60% of its fine chemical products could be manufactured with biotechnology tools.8 • The need to diversify energy sources and the search for cleaner fuels make biofuels a clear possibility for the future. Bioethanol is already being integrated into petrol and demanded for its growth at a rate of 18% per year. • Microorganisms and their enzymes control important chemical and food transformation processes. Knowledge of these genomes will enable more efficient processes at lower costs. There are already significant public and private consortiums to exploit microbial genomes. 5 Technological Prospective Report on the Impact of Biotechnology on the Public Health System. OPTI-Genoma España 2003 (http://www.gen-es.org/02—cono/02—cono.cfm?pag=0309) 6 Jeffrey S. Ross and Geoffrey G. Ginsburg. Integrating diagnostics and therapeutics revolutionizing drug discovery and patient care. Therapeutic focus-Reviews. DDT Vol. 7, No. 16, August 2002. 7 Draft Guidance for Industry: Pharmacogenomic Data Submissions (http://www.fda.org/cder/guidance/5900dft.pdf). 8 Biotechnology for Clean Industrial Products. Towards Industrial Sustainability. OECD, 1998. 13
  13. 13. CONTEXT O New Drugs and Vaccines: biotechnology enables us to advance in the knowledge of molecular and genetic processes, which are ultimately responsible for the appearance of diseases and the proliferation of infections. • There are over 155 biotechnological drugs and vaccines that increase the expectancy and quality of life of 325 million people. In addition, 370 biotechnological drugs against diseases such as cancer, Alzheimer’s, multiple sclerosis, arthritis, AIDS and heart disease are currently being developed.9 • In 2004, the biopharmaceutical market generated profits of 45,000 million dollars, a figure which is expected to rise to 98,000 million dollars in 2011.10 • Therapeutic monoclonal antibodies are a new therapeutic road for diseases such as cancer. Around a dozen such antibodies have been approved and 100 are being developed for a current 300-million-dollar market, which is growing by 50% every year.11 It is beyond a doubt that biotechnology developments will be possible thanks to the wealth of knowledge regarding the processes of life, in particular genetic and molecular processes, which are ultimately responsible for the development of living beings. In the next few years, genomics, proteomics and metabolomics technologies, which enable the full and integrated study of genes, of their “proteins and other molecules” expression and of their roles, will be the main drivers for this development. Finally, it is worth noting that biotechnology is, by definition, global in its impact: • Due to its very nature: since it is technology it can be applied horizontally to multiple areas or sectors including medicine, pharmacy, agriculture, food, energy, industrial production and the environment. • Due to its scope: each and every one of the more than 6,000 million people comprising the world’s population do or will require high quality health assistance, healthy and harmless food and affordable consumer products at some point in his or her life. • Due to global economy: biotechnology is establishing itself as one of the main drivers for world economic growth in both emerging (Asia) and developed economies (USA). 9 http://www.bio.com/ 10 Frost & Sullivan. Strategic Analysis of the World Plant Molecular Farming Market. 11 European Therapeutic Monoclonal Antibodies Market. Frost & Sullivan Report. 14
  14. 14. SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES THE BUSINESS RELEVANCE OF BIOTECHNOLOGY IN 2003 (LISTED COMPANIES)12 Global USA Europe Canada Asia Profits (€M) 40,967 31,552 6,569 1,522 1,324 R&D Expenses (€M) 16,400 11,939 3,725 545 191 Number of Employees 195,820 146,100 32,470 7,440 9,810 R&D/Employee Expenses (€) 83,748 81,717 114,720 73,334 19,465 Companies 4,471 1,473 1,861 470 667 GROWTH OF BIOTECHNOLOGY IN 1998-2003 (%)13 USA Europe Canada Profits 115% 754% 246% R&D Expenses 101% 556% 224% Number of employees 38% 184% 176% Companies 12% 58% 190% All over the world, employment, number of companies and economic benefits from the biotech sector soars tremendously. It is not in vain that this growing sector is considered one of the new sources of wealth and employment for both developed and under developed countries. The sensible and strategic application of biotechnology both from the scientific and productive perspectives could also constitute a prosperous stance for the Spanish society. 12 Source: Resurgence. The Americas Perspective Global Biotechnology Report 2004. Ernst & Young. 13 Source: Resurgence. The Americas Perspective Global Biotechnology Report 2004. Ernst & Young. 15
  15. 15. SITUATION 2. The Situation of Biotechnology in Spain The current situation and trend of biotechnology in Spain has been classified with a series of indicators covering its full life cycle starting from market research. Otherwise, we would only have a partial picture of this “sector.” The classification is based on the OECD’s definition of biotechnology.14 BIOTECHNOLOGY IN SPAIN: SCIENTIFIC INDICATORS 2000 2001 2002 2003 2004* Scientific Production (number of biotechnology 748 845 827 959 1.029 and molecular biology articles) Contribution to the world’s scientific production (%): 1.52% 1.58% 1.67% 1.69% 1.75% molecular biology Contribution to the world’s scientific production (%): 4.04% 4.01% 4.05% 4.10% 4.12% biotechnology * Estimated. Source: CINDOC-CSIC. Spanish research in the molecular biology and biotechnology fields is hearty, as shown by the fact that there is a significant contribution to the world’s scientific production, i.e. the number of scientific articles published, and that this contribution has been increasing over the last few years. Spain is currently the fourth European country in scientific production relating to biotechnology, and the seventh in relation to molecular biology. Spanish research in these disciplines is targeted to knowledge production, i.e. basic research, although the applied component of Spanish research in these scientific disciplines is larger than the world’s average. The quality of Spanish scientific publications, as measured by the impact of the magazines in which these articles are published, places us in sixth place for biotechnology15 and seventh for molecular biology16 in the European ranking. 14 ”The application of science and technology to living organisms as well as parts, products and models thereof and to alter living or non-living materials for the production of knowledge, goods and services.” 15 Scientific biotechnology articles published in scientific magazines with an impact of more than 2.7. 16 Scientific molecular biology articles published in scientific magazines with an impact of more than 4.3. 16
  16. 16. SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES Spanish Scientific Production Relating to Biotechnology: Distribution by Sector Agroindustrial Basic vs Applied Research Animal 2% Plant Health4% Food Health Technology 5% 1% Spain 1,421 1,958 Environment 7% Food Worldwide 35,084 120,856 and Basic Agriculture 44% 10% % 0 10 20 30 40 50 60 70 80 90 100 Industrial Biotechnology Biochemistry Products and microbiology and mol biol 13% Human Source: CINDOC-CSIC. Health 14% Source: CINDOC-CSIC. According to the prestigious institution ISI THOMSON,17 quality—as measured by the relative Contribution to World Scientific impact of Spanish publications relating to Production Relating to Molecular Biology (%) microbiology, biochemistry, immunology and 2000-2003 Period molecular biology—increased significantly between Luxembourg 1993 and 2003. However, this is still a much Greece lower impact than we would hope for, which Ireland Portugal means we still need to invest in improving the Finland quality of research. Austria Denmark Belgium According to the Spanish National Statistics Spain Institute (Instituto Nacional de Estadística, INE), Sweden there are 6,800 biotechnology researchers, out of Netherlands a total of 9,000 people carrying out biotechnology Italy France R&D activities at universities, hospitals and public United Kingdom research centres. The scientific areas in which we Germany are most productive include research genetics, 0 1 2 3 4 5 6 7 8 proteins and other molecules to generate Source: CINDOC-CSIC. knowledge, as well as biotechnology of processes to generate industrial, food and chemical Contribution to World Scientific applications, among others. Production Relating to Biotechnology (%) 2000-2003 Period Luxembourg Greece Ireland Portugal Austria The scientific component of Spanish Finland molecular biology and biotechnology is Denmark internationally competitive. Spanish Belgium Sweden scientists working in these disciplines form Italy the basis for the development of Netherlands biotechnology in Spain. Spain France Germany United Kingdom 0 1 2 3 4 5 6 7 8 9 Source: CINDOC-CSIC. 17 Science in Spain. The Monthly Newsletter by Juan E. Iglesias. ISI. 17
  17. 17. SITUATION BIOTECHNOLOGY IN SPAIN: TECHNOLOGY INDICATORS 2000 2001 2002 2003 Spanish patents granted by the 1 4 6 7 European Patents Office18 Spanish patents granted by the 11 15 18 14 US Patents Office19 Income from patent exploitation €0.6 M €0.73 M €1.72 M €2.3 M* Economic volume of contracts between €21 M €26 M €42 M €53 M* universities and companies Number of contracts between universities 680 794 827 901* and companies * Estimated. Source: Prepared by Genoma España on the basis of data provided by the SPTO, EPO, USPTO and the Research Result Transfer Office’s Network. Spanish biotech researchers contribute approximately 0.47%20 to European patents applications, which is lower than their contribution to the world’s scientific production. There is therefore an important gap between the generation of knowledge and the production of patentable applications in Spanish biotechnology. Interestingly, we know from a study conducted by CINDOC-CSIC that the scientific publications of 40% of Spanish biotech research groups are a basic reference for American patents applied for by US companies and researchers, in particular for biotechnology applications in the fields of human health, industry and food and agriculture. Applications to the European Patents Granted by the European Patents Office: Biotechnology Office: Biotechnology United kingdom 5.62% United Kingdom 8.59% Germany 5.35% Germany 8.39% Various countries* 4.85% Various countries 7.04% France 2.27% France 5.34% Denmark 1.35% Denmark 2.53% Sweden 0.53% Italy 1.15% Spain 0.47% Sweden 0.99% Italy 0.38% Netherlands 0.75% Finland 0.21% Austria 0.44% Netherlands 0.17% Finland 0.24% Austria 0.15% Spain 0.16% Ireland 0.04% Belgium 0.08% Portugal 0.02% Portugal 0.04% Belgium 0.02% Ireland 0.04% Greece 0.01% Luxembourg 0.00% Luxembourg 0.00% Greece 0.00% * Patents held by more than one country. Source: Prepared by Genoma España on the basis of data provided by the EPO. 18 The absolute values are obtained according to the OECD’s definition of biotecnhnology (A01H 1/+, A01H 4/00, A61K 38/+, A61K 39/+, A61K 48/00, C02F 3/34, C07G 11/00, C07G 13/00, C07G 15/00, C07K 4/+, C07K 14/+, C07K 16/+, C07K 17/+, C07K 19/00, C12M +, C12N +, C12P +, C12Q +, C12S +, G01N 27/327, G01N 33/53+, G01N 33/54+, G01N 33/55+, G01N 33/57+, G01N 33/68, G01N 33/74, G01N 33/76, G01N 33/78, G01N 33/88 and G01N 33/92). 19 Technology Profile Report. Patent Examining Technology Centrer, groups 1630-1660, Biotechnology. USPTO. 20 According to the Spanish Patents Office, a total of 24,021 patent applications were published between 2000 and 2003. 112 of these were Spanish. This study was conducted according to the international patent classification (C12N). 18
  18. 18. SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES Although royalties and other payments for Contracts between Universities exploiting patents represent token amounts and Companies (Spanish public research centres and universities 60 1.000 901 receive little more than two million euros in the 827 900 794 53 M€ biotechnology field), the economic volume of 50 800 public contracts between universities and public 680 42 M€ 700 centres on the one hand and companies on the 40 Millions of € Proyectos 600 other is growing considerably. The number of joint projects and their economic volume has doubled 30 500 26 M€ since 2000, reaching over 50 million euros in 21 M€ 400 20 2003. 300 200 10 100 0 0 2000 2001 2002 2003 In the hypothetical technology transfer coin of Spanish biotechnology, contracts between public researchers and companies are “heads,” whereas patents are undoubtedly “tails.” There is more focus on the provision of services than on the development of products. BIOTECHNOLOGY IN SPAIN: ECONOMIC AND FINANCIAL INDICATORS 2000 2001 2002 2003 2004* Public subsidies for R&D: €87 M €104 M €177 M €187 M €220.3 M universities and public research centres21 Public subsidies for R&D: companies22 €4.7 M €7 M €8.8 M €12 M €14.4 M Average cost per project subsidised by the €71,387 €79,195 €86,618 €102,930 €113,444 National R&D Plan (Plan Nacional de I+D) European R&D funding €27 M €19 M €16 M €30 M €22 M RDI investment by companies23 €94 M €129 M €181 M €238 M €286 M Venture capital investment €5 M €6.2 M €6.8 M €3.6 M €3.5 M % of venture capital invested in biotechnology as compared with the total 0.381% 0.498% 0.700% 0.267% 0.18% amount * Estimated. Source: Developed by Genoma España from data sources of MEC, MSC, INE, CDTF y CC.AA. 21 Biotechnology Projects in accordance with the OECD’s definition of the National RDI Plan (Biotechnology National Plan, Biomedicine National Plan, Agricultural Technologies and Resources National Plan, National Plan for the General Promotion of Knowledge and Health Research Fund), of the Spanish Autonomous Regions’ RDI Programmes and the infrastructure co-funded by FEDER, MEC and the Autonomous Regions. 22 Biotechnology Projects from the PROFIT Programme and the Autonomous Regions. 23 Business RDI investment includes the intangible fixed assets of companies fully and partly devoted to biotechnology. Such fixed assets have been multiplied by a coefficient representing the amount of investment in biotechnology as compared with total investment by sector. These coefficients were provided by the Spanish National Statistics Institute. 19
  19. 19. SITUATION Public subsidies for biotechnology, whether from the Ministry of Education and Science, the Ministry of Health and Consumer Goods, the Autonomous Regions or the European Commission, have grown considerably in the last five years, specifically at an annual average rate of 22.6%. Furthermore, total RDI investment in biotechnology by companies increased at an even greater rate than public subsidies in the same period. This growth is an average annual rate of 32.3%. The large increase in public investment in biotechnology has been accompanied by an even larger increase in the business sector. Public R&D subsidies act as catalysts for private investment in Spanish biotechnology. Public Funds and Private Investment Estimated Distribution in Biotechnology of R&D Expenditure 350 44% 56% 2000 50% 50% 300 286 2001 257 47% 53% 2002 250 238 229 Millions of € 51% 49% 2003 202 200 53% 47% 2004 181 55% 45% 2005 150 130 129 57% 43% 2006 119 94 59% 41% 2007 100 2008 61% 39% 50 2009 63% 37% 5 6 7 4 2010 4 0 66% 34% 2000 2001 2002 2003 2004 Total public subsidies for R&D Business R&D investment % Public investment scale Venture capital investment % Private investment scale Source: Prepared by Genoma España. Source: Prepared by Genoma España. If the current growth rates for both public subsidies and private investment in biotechnology R&D are maintained, an ideal trend of R&D expenditure in Spanish biotechnology—2/3 private and 1/3 public—can be expected for the year 2010. It is worth highlighting that only two Autonomous Regions—Galicia and the Basque country—are investing more than they are receiving from the National Government. Specifically, Galicia invests over 10 times more than it receives for business R&D, and the Basque country invests almost 4.5 times more than it receives for R&D for its universities and public research centres. National subsidies for business biotechnology to carry out innovation and technological development projects represent only 6% of the total. However, we must also note that many of these projects are funded by soft and/or participating credit, of the type granted by the Ministry of Education and Science, the Spanish National Innovation Company (Empresa Nacional de Innovación, ENISA) and the Centre for Industrial Technological Development (Centro para el Desarrollo Tecnológico Industrial, CDTI), among others. Between 2000 and 2003, 75% of funds for innovation and technological development came from national funds. The remainder was provided by Autonomous Communities. Public biotechnology subsidies focus on the production of scientific knowledge; changing this focus could damage our most competitive element: basic research. On the contrary, “it would be more sensible to complement it with new programmes, funds or tools to cover the innovation and technological development aspects …”24 24 Economic Implications of Biotechnology in Spain. Miguel Vega García. http://www.madrimasd.org/informacionidi/analisis/default.asp. 20
  20. 20. SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES Distribution of Public Biotechnology Distribution of Business Investment Subsidies by Autonomous Community in Biotechnology R&D Cantabria Murcia Aragon Asturias Basque Castile-La Mancha 1% 1.00% 0.09% 0.01% Country Canary I. 2% Balearic I. Galicia 2.45% Extremadura 0.02% 1% 0.87% Asturias 1% Castile- 2% La Rioja Castile Leon La Mancha Navarre Canary I. 0% 0.84% 0.17% 2% 2% Valencia La Rioja 5.62% 0.03% Murcia Aragon Madrid 3% 2% 24% Andalusia 5.98% Basque Country 6% Galicia Catalonia 7% 6.04% Madrid Catalonia 76.88% Castile Leon 19% 7% Valencia 9% Andalusia 14% The distribution of public subsidies25 and private investments26 in biotechnology R&D per autonomous region shows that the vast majority of funds and investments go to Madrid, Andalusia and Catalonia. Over 75% of private investment is in Madrid, specifically in the company PharmaMar, which in turn represents 75% of total business investment in biotechnology R&D. Distribution of Public R&D Distribution of Business R&D Investment Subsidies by Sector by Autonomous Community Animal Environment Industrial Technological Technological Health 0.73% Bioprocesses Developments Developments 1.04% and Biochemistry and Services 2.33% Bioprocesses Diagnosis 3.55% 1.40% Other 0.6% and Vaccines Sales and 4.75% 5.43% Distribution 0.45% Food Food and food 5.24% Bioprocesses 6.06% Agriculture, Cattle raising Human Agrobiotechnology and Fishing Health and Biofactories 16.28% 69.03% 10.67% Bio-pharma 72.44% There are parallelisms in the distribution of public subsidies and private investments in biotechnology R&D by economic or industrial sector. The leading sector is Human Health-BioPharma. Some sector-specific applications such as agriculture and cattle raising receive more support from the Government; whereas others such as bioprocesses receive more support from private business investments. If we remove the company Pharmamar from the business investment in order to study its effect on distribution by sector and by region, the similarity in the distribution of business investment and public distribution by autonomous community becomes obvious. However, there is a clear difference in per sector distribution: the biopharmaceutical sector is no longer the largest in terms of investments and that position is instead taken over by food and industrial bioprocesses and molecular diagnostics and vaccines. 25 Public subsidies include subsidies for national, regional and European R&D projects and for biotechnology infrastructure, both for universities and research centres and for companies, for the period between 2000 and 2003. 26 Private biotechnology R&D investment is calculated as the intangible fixed assets of companies fully and partly devoted to biotechnology in the period between 2001 and 2002. 21
  21. 21. SITUATION With respect to venture capital, the huge gap between biotechnology venture capital in Europe and in the United States becomes evident. In the year 2000, venture capital investments in biotechnology as a percentage of the total were about the same on both sides of the Atlantic. Five years on, they are an order of magnitude apart. American biotechnology companies have been able to attract the available venture capital funds including European ones. The significant public effort made in Europe in 2000 and 2001 to encourage venture capital investment in biotechnology has not yielded the expected results. In Spain, the figures are under €4 million in 2004. We lack a financial sector with an interest in Spanish biotechnology, or not enough reputation to attract international finance. In spite of this, there are several initiatives from universities or autonomous communities to build up the capital of small spin-off companies, which are emerging from the academic environment. Companies such as ENISA, CDTI and Genoma España are also working in that direction. It is also worth mentioning that two important extensions of privately subscribed capital in biotechnology companies—specifically €16 million for Neuropharma and €6 million for Genetrix were made during 2004. Venture capital investment in Spanish productive biotechnology is almost non-existent. Investors argue that there are no solid projects for them to put their money in. Venture Capital Biotechnology Investment Venture Capital Investments in Biotechnology (Millions of €) as Percentage of the Total 10,000 25% 3,551 M€ 3,099 M€ 2,838 M€ 3,186 M€ 2,600 M€ 20.4% 1,132 M€ 1,318 M€ 20% 980 M€ 828 M€ 1,000 736 M€ 16.1% 15% 12.6% 100 10% 7.3% 10 6 M€ 7 M€ 5.4% 5 M€ 5% 3.2% 3.5% 4 M€ 4 M€ 2.5% 2.2% 3.3% 0.4% 0.5% 0.7% 0.3% 0.2% 1 0% 2000 2001 2002 2003 2004 2000 2001 2002 2003 2004 Spain Europe USA Spain Europe USA Source: Prepared by Genoma España from data provided by Biocentury, Capital & Corporate, Ernst & Young and Ascri. 22
  22. 22. SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES Biotechnology in Spain: Business Indicators In order to describe the sector we classify the companies, which operate in this environment, as follows: Classification of Biotechnology Companies: 2004 Companies fully devoted to biotechnology (CFDB) Number – Biotechnology accounts for over 80% of their activities – Biotechnology accounts for over 50% of their turnover – Investment: a clear commitment to conducting biotechnology RDI in Spain 102 (research facilities) – They submit calls for public biotechnology research proposals in Spain Companies partly devoted to biotechnology (CPDB) Number – Although some of their main business lines are biotechnology-related, biotechnology accounts for less than 80% of these companies’ activities – Biotechnology accounts for part of their turnover 114 – Investment: a clear commitment to conducting biotechnology RDI in Spain (research facilities) – They apply to take part in biotechnology research projects in Spain Companies that use biotechnology (CUB) Number – Some of their main business lines are biotechnology-based 100 – Part of their turnover is biotechnology-related Biotechnology industry service companies (BISC) Number – Consultancies, advisers, etc – Bioinformatics 51 – Companies that market biotechnology products (and do not conduct RDI in Spain) – Other auxiliary services 23
  23. 23. SITUATION Thanks to this classification, we know in which Distribution by Autonomous Community context we can implement policies to promote and stimulate biotechnology growth. In total, there are MADRID 118 367 companies with an interest in biotechnology. CATALONIA 96 102 of these are fully devoted to this new technology sector; 114 are partly devoted to ANDALUSIA 31 it—i.e. some of their business lines include biotechnology—and the remainder are services BASQUE COUNTRY 25 and/or marketing companies. VALENCIA 23 As far as regional distribution is concerned, there CASTILE LEON 20 are 3 large groups. The first one includes almost 60% of the country’s biotechnology activities, which MURCIA 17 is made up of technology-based companies in the case of Madrid and pharmaceutical companies in GALICIA 12 Catalonia. The second group represents 27% of the industry with a homogeneous distribution of ARAGON 8 companies by sub-sector. The third group, ASTURIAS 5 comprising Galicia and Murcia, represents 8%. CANARY ISLANDS 3 NAVARRE 3 EXTREMADURA 2 LA RIOJA 2 CANTABRIA 1 CASTILE LA MANCHA 1 BALEARIC ISLANDS 0 TOTAL 367 Comparing regional distribution figures for public R&D and existing companies show a direct relationship, which confirms the stimulating effect of R&D investment on the development of the sector. A huge significant fact is the interest that the use of biotechnology applications is arousing in the business world: the number of fully devoted companies doubled between 2000 and 2004. 2000 2001 2002 2003 2004 Number of companies fully devoted to 55 66 80 90 102 biotechnology (CFDB) Number of employees in CFDB 905 1,205 1,654 1,571 1,793 CFDB turnover €151.3 M €173.5 M €200.4 M €296 M €391 M Source: Prepared by Genoma España from data provided by the Commercial Register, the National Statistics Institute and own databases. 24
  24. 24. SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES R&D Investment in Fully Turnover of Fully Devoted Companies: Devoted Companies: Distribution by Sector Distribution by Sector Diagnosis Technological Agrobiotechnology Industrial Food and vaccines developments and factories bioprocesses and food 4.99% and services 0.88% and biochemistry bioprocesses 1.51% 5.53% 2.53% Sales and distribution Agrobiotechnology Industrial Technological and biofactories bioprocesses 0.17% developments 1.14% and biochemistry and services 5.16% 9.98% Sales and Food and distribution food 14.36% bioprocesses 7.8% Diagnosis and vaccines Biopharmaceutics Biopharmaceutics 14.89% 51.58% 79.42% A small analysis of the companies fully devoted to biotechnology shows that the main R&D27 investment area encompasses the development of pharmaceutical products. Where as far as turnover28 is concerned, the health sectors are also the most significant. In addition, it is worth noting that, although R&D investment in technological services and developments accounts for only 1.51%, these services and developments account for almost 10% of this emerging business sector’s turnover. Another factor pointing to the boom of biotechnology companies is the high number of employees. Expenditure doubled during the cited period. The decrease in the number of employees in the last year was due to a single company: PharmaMar. This company, which alone represents over half the sector, had to deal with a restructuring process when the regulating agency (EMEA) delayed the marketing of its first drug. Personnel Expenditure vs Number of Employees Millions 100 2,000 1,571 1,654 Spanish Biotech firms (fully devoted) 80 1,500 450 2000 60 1654 1571 391 M€ 1800 1,205 400 1793 350 1600 905 300 1205 296 M€ 1400 40 1200 250 905 1,000 200 M€ 1000 200 173 M€ 151 M€ 800 150 600 20 44 M€ 52 M€ 64 M€ 89 M€ 100 90 102 55 66 80 400 50 200 0 0 0 500 2000 2001 2002 2003 2004* 2000 2001 2002 2003 Turn over Firms Employees Personnel expenditure Number of employees 27 Private biotechnology R&D investment is calculated as the intangible fixed assets of companies fully devoted to biotechnology in the period between 2001 and 2002. 28 Business turnover in biotechnology is calculated as the net sales of companies fully devoted to biotechnology in the period between 2001 and 2002. 25
  25. 25. SITUATION It is very difficult to tell what percentage of the turnover and investment of partly devoted companies corresponds to biotechnology activities. We have therefore decided to reflect this business group’s net figures in this section, although we have used estimated correction factors for the economic impact of biotechnology (see the next section). Turnover of Partly Devoted R&D Investment in Partly Devoted Companies: Distribution by Sector Companies: Distribution by Sector Agrobiotechnology Food Technological Industrial and biofactories and food services and bioprocesses 4.03% bioprocesses developments and biochemistry 1.43% 4.23% 1.45% Food Technological and food services Industrial Sales and bioprocesses and developments bioprocesses distribution 0.86% 4.40% and biochemistry 8.23% 0.05% Sales and distribution 8.01% Agrobiotechnology and biofactories 15.05% Diagnosis and vaccines 19.15% Diagnosis and vaccines Biopharmaceutics Biopharmaceutics 25.63% 62.93% 44.55% The distribution by sector charts show a direct relationship between investment percentage and turnover. The pharmaceutical sector has the best results, followed by companies that focus on diagnosis and the development of vaccines. It is worth noting that the turnover of agricultural companies is over three times as high as the amount invested in research by them. Similarly as in the case of fully devoted companies, Personnel Expenditure vs Number personnel expenditure has doubled. The total of Employees in CPDB number of employees rose to 19,000 in 2003 with Millions an average growth of around 4.5% during the 1,400 19,056 19,500 cited period. 1,200 19,000 18,099 18,500 1,000 18,000 17,330 800 17,500 16,627 600 17,000 16,500 400 691 M€ 775 M€ 923 M€ 1.189 M€ 16,000 200 15,500 0 15,000 2000 2001 2002 2003 Personnel expenditure Number of employees 26
  26. 26. SPANISH BIOTECHNOLOGY: ECONOMIC IMPACT, TREND AND PERSPECTIVES Biotechnology in Spain: Perception Indicators Spanish society’s attitude towards biotechnology is Evolution of the Optimism Index more optimistic and favourable than the European in Spain and Europe average. Spaniards’ degree of knowledge and 0.9 involvement in science and technology debates has 0.8 SPAIN 0.7 traditionally been low. However, there was an 0.6 inflection point in 1999 with increased interest in Index 0.5 biotechnology issues and their consequences. EUROPE 0.4 0.3 0.2 0.1 0.0 1991 1993 1996 1999 2002 Source: Prepared by Genoma España from Eurobarometer 58.0. The number of news items has multiplied by five in Presence and Trend of Biotechnology in the Media the last 10 years showing that many of the most 1,600 relevant biotechnology applications have not gone EFE 1,400 unnoticed by the mass media. The biotechnology No. of Biotech Texts 1,200 culture is undergoing a deep maturing process, 1,000 NEWSPAPERS which will lead to a greater polarisation of opinions and more positive attitudes towards biotech issues. 800 600 400 200 0 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 Source: Prepared by Genoma España from data provided by the newspapers El País and El Mundo and EFE News Agency. The applications with the greatest social impact Trend of Current Biotechnology Relevance relate to cloning, transgenic food, the medical Genoma ántrax 7 implications of biotechnology, the discovery of new Andalucía. Ley Clonación mulo 4 40 investigación genes and genome sequencing. con embriones 4 36 35 Células Clonan ratas 3 Number of Articles embrionarias Clonación Ley Reproducción Protocolo 30 Bioseguridad Moratoria embriones Asistida 5 alimentos Genoma 20 27 Dolly 14 Humano 25 Bernat 25 25 P.E.12 transgénicos 24 15 Soria Ley Células 4 12 21 madre 4 20 21 19 20 Preñez 17 18 18 Dolly 5 17 14 15 15 13 11 10 10 5 Borrador genoma Directiva humano 5 OMG 4 0 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 Source: Prepared by Genoma España from data provided by the newspapers El País and El Mundo. Public opinion can shape the future development of biotechnology. This has already happened elsewhere, for example, in the energy sector. Biotechnology has ethical, moral, political and social implications. The main sources of information have fortunately been universities and research centres, which ultimately means the researchers. However, the Government started to appreciate its significant importance in 1994. 27

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