Life Science in Iceland Life science in Iceland – Summary
A population with all three sets of data: genetic, medical and genealogical
70-90% volunteer participation in research projects
Unique research databases and bio-banks containing medical and pathological records
Leading companies in the field of generic drug production and medical technology such as diagnostics and prosthetics
Advanced research infrastructure and a relatively large number of highly qualified specialists
Excellent access to high-throughput laboratories
Environment and climate enable pesticide-free agriculture and horticulture with ideal, automatic in-field containment of many transgenic plants
Geothermal areas which foster an amazing biodiversity, including unique thermophile bacteria
Europeʼs most competitive economy and #4 globally according to the IMD World Competitiveness Yearbook 2005
Positive business environment with minimum red tape, only 18% corporate income tax and a simple and efficient tax system
Ideal location between North America and Europe, linking two of the worldʼs strongest markets and research communities
As a founding member of European Economic Area, Iceland is part of the single European market ensuring tariff-free access for most products
Companies, research institutions and universities have access to European Union R&D research programmes and are eligible for EU funding
Invest in Iceland Agency
Invest in Iceland Agency is an independent agency While every effort has been made to ensure that of the Ministry of Industry and Commerce. The the information in this publication is correct, the Agency’s advisors provide information free of publishers cannot accept liability for any errors or charge and expert confidential service on all omissions. aspects of investments in Iceland. The Agency assists in finding suitable research or business For further information on Iceland please partners in Iceland, provides contact information contact the Invest in Iceland Agency. The entire or establishes direct contact to relevant entities. text of this publication is available on the Invest This report is compiled and written by the Invest in Iceland Agency websites: www.invest.is in Iceland Agency. The sources are official data and www.icelandbio.com and there are also and reports, information supplied by individual references to further sources of information on companies and corporate websites. Some of the the internet. Reproduction for non-commercial text is published by courtesy of Reykjavik Resources, distribution is allowed provided that the source is the City of Reykjavik investment agency. acknowledged.
www.icelandbio.com
4 Index
LIFE SCIENCE IN ICELAND – SUMMARY ...... 4
INTRODUCTION TO ICELAND’S UNIQUE RESOURCES ...... 6 A SOURCE OF ENERGY AND INSPIRATION ...... 6 NATURAL AND HUMAN RESOURCES ...... 6
THE GENEALOGICAL GOLD MINE AS A RESOURCE ...... 7 GENOMICS ...... 7 POPULATION BASED RESEARCH ...... 7 BIOBANKS AND REGISTRIES ...... 8 Access to biobanks in Iceland ...... 8 Overview over licensed biobanks in Iceland ...... 9
THE EXTREME NATURE AS A RESOURCE ...... 10 THERMOPHILE BACTERIA ...... 10 MARINE PRODUCTS ...... 10 SELECTIVE BREEDING OF FISH ...... 11
THE CLIMATE AND ENVIRONMENT AS A RESOURCE ...... 12 MOLECULAR PHARMING – CONTAINING TRANSGENIC PLANTS ...... 12 GROWTH CHAMBERS – CONTROLLED ENVIRONMENT ...... 12
THE ADVANCED HEALTH INDUSTRY AS A RESOURCE ...... 13 HIGH-TECHNOLOGY RESEARCH HOSPITAL ...... 13 BIOMEDICINE ...... 14 STEM CELL RESEARCH ...... 14 MEDICAL DEVICES ...... 15
INFRASTRUCTURE AS A RESOURCE ...... 16 THE GROWTH OF LIFE SCIENCES IN ICELAND ...... 16 EDUCATION AND RESEARCH INSTITUTIONS ...... 16 INVESTMENT IN RESEARCH ...... 17 LEGAL FRAMEWORK AND PATENTS ...... 18 Science laws ...... 18 Data protection and privacy ...... 18 Biobanks and the Icelandic Health Sector Database ...... 18 Biotechnology ...... 19 Genetically modified organisms ...... 19 Embryonic stem cell research ...... 19 Patenting ...... 19 INTERNATIONAL COOPERATION AND FUNDING ...... 20 ICT AND LOGISTICS ...... 20
THE POSITIVE BUSINESS ENVIRONMENT AS A RESOURCE ...... 21 ICELAND’S COMPETITIVENESS ...... 21 DOING BUSINESS IN ICELAND ...... 21
FURTHER INFORMATION ...... 23 CORPORATE WEBSITES ...... 23 OTHER SOURCES OF INFORMATION ...... 27
5 Introduction to Iceland’s unique resources
Genealogical gold mine Iceland’s resource in human genetics – a population with all three sets of data: genetic, medical and genealogical – is created by the Icelandic Sagas, old church records, general interest in genealogy, widespread voluntary participation in research programs and extensive biobanks. The entire present-day population is covered by a genealogy database, stretching back to the settle- ment of the country more than 1000 years ago
Iceland is Europe’s most competitive economy and ranks #4 overall, following the US, Hong Kong and Singapore, according to The IMD World Competitiveness Yearbook 2005. This positive business environment is just one of Iceland’s resources for Life Science, biotechnology and the medical industry. With total R&D expenditure of over 3% of GDP, an advanced health care system, expertise in harvesting from the riches of unique natural resources, technical sophistication, comprehensive biobanks and data registries, an ideal location between two of the world’s strongest markets and a population both positive towards research programs and willing to volunteer, it is no wonder that Iceland has experienced a rapid expansion in life science. Today Iceland is home to world-leading companies in population-based genomics, ecological genomics involving thermophilic bacteria from geothermal areas, molecular pharming of transgenic plants, prosthetics and medical diagnostic devices.
A source of energy and inspiration
Iceland lies on top of the Mid-Atlantic Ridge, where the tectonic plates of Europe and North America meet. The constant movement of these plates explains the volcanic and geothermal activity in Iceland’s nature which is a massive source of energy. Some have pointed out that Iceland lies midway between Europe and America not only geologically but also culturally, enjoying both the comprehensive Scandinavian health care and educational system and the North American belief in entrepreneurship and individual freedom. Living on an island, it has always been a necessary and natural part of the lives of Icelanders to go abroad to seek knowledge and new influences and then adapt these to their own special circumstances. Good communications and transport have always been vital and Icelandic scientists have graduated from universities all over the world. International cooperation is an important part of Icelandic research and development. It is easier to understand what makes Iceland so inspiring for the life science sector, bearing its situation midway between the old and the new world, in the vortex of international trends in culture, education and science, where science and culture meet the forces of nature.
Natural and human resources
Apart from being well educated, open-minded and willing to embrace new technologies, the population of Iceland offers a rare resource for population-based genomics: A population with all three sets of data – genetic, medical and genealogical. This “genealogical gold mine” is created by the Icelandic Sagas, old church records, general interest in genealogy, widespread voluntary participation in research programs and extensive biobanks. The entire present day population is covered by a genealogy database, stretching back to the settlement of the country more than 1100 years ago. The identification of genes underlying various common diseases, from heart attack to cancer, has already led to the first clinical trials of preventive target drugs in Iceland. Rich natural resources – an abundance of inexpensive renewable energy from geothermal and hydroelectric power plants, geothermal areas with amazing biodiversity, including thermophilic bacteria, and one of the world’s richest fishing grounds surrounding the country – all these factors open new possibilities. Novel thermophilic enzymes with highly unusual characteristics and marine products such as chitin derivatives are being developed. Iceland’s mild climate and environment enable pesticide-free agriculture and horticulture and offer automatic containment of many transgenic plants. Valuable proteins are being produced from transgenic barley, and inexpensive geothermal water and electricity make Icelandic greenhouses ideal growth chambers with a controlled and pure environment. 6 The genealogical gold mine as a resource
Positive attitude – General participation Over half the adult population of Iceland has volunteered to give samples for gene research. Since 1955 the Icelandic Cancer Society has gathered information on over 30,000 cases of cancer in the unique Cancer Registry. The Icelandic Heart Associa- tion is carrying out one of the most extensive phenotyping ever carried out in an epidemiology study, the Age, Gene/Envi- ronment Suceptibility (AGES) Reykjavik study comprising the approximately 8000 remaining men and women from the 38 year long prospective Reykjavik study of around 20.000 people
Virtually all of today’s 293,000 Icelanders are descended from Norwegians and Celts who settled in Iceland in the 9th and 10th centuries. While the original settlers displayed ample genetic diversity, the population has remained in relative genetic isolation, which limits the number of individual mutations, greatly simplifying the process of screening for them. It also increases the extent of linkage disequilibrium, allowing association studies to identify common polymorphisms of minor effect that would require ten times as many subjects in typical western populations. Screening is also facilitated by the Icelanders’ fascination with genealogy. Details of births, marriages and deaths have been kept in church records since the 17th century, and even earlier information is available Iceland Genomics Corporation and in the sagas and other medieval manuscripts housed in the University of Iceland. These records have the Icelandic Cancer Project recently been collected in computerized databases – probably the most comprehensive genealogical www.icelandgenomics.com database of any population in the world. Iceland Genomics Corporation (IGC) is a privately A population with all three sets of data – genetic, disease and genealogical – is a scarce resource in held cancer biology company using an innovative “clinical genomics” approach to understand human genetics. In Iceland, companies have brought this information together, enabling them to conduct the underlying mechanisms of cancer, isolate genome- and population-wide linkage scans for disease-linked genes. This exceptional combination and characterize new therapeutic targets for cancer, assess outcomes of specific therapies of resources allows companies to conduct large population genomic studies of human diseases. The in genetically defined subcategories of cancer magazine BioTech Scandinavia called this “Iceland’s genealogical gold mine” in a recent front page patients and optimize clinical trials for success. article (1/2005, www.biotechsweden.se). Why Iceland? Iceland's founder population provides advantages for research to study complex disorders such as cancer. This has been repeatedly demonstrated Genomics in recent years with the discovery of genes and biomarkers associated with central nervous “Despite a population of only 290,000 Iceland has become globally known for its biomedical sector” system disorders, cardiovascular disease, obesity and cancer, to name only a few. Data from the reports BioTech Scandinavia. This can be traced to an enormous growth which took place within the Icelandic population were also important in genomics industry in the last decade of the 20th century. In a report to the OECD, the Icelandic Center identifying both the BRCA1 and BRCA2 genes, for Research (Rannis) notes that the “real breakthrough came with the founding of the two genome and a founder mutation in each gene is present in the Icelandic population (Thorlacius et al. (1996) companies, deCODE Genetics (Íslensk erfðagreining) in 1996 and The Iceland Genomics Corporation (IGC Nature Genet 13, 117; Bergthorsson (1998) Hum or Urður, Verðandi, Skuld) in 1998, both basing their business ideas on the genealogical transparency Mutat 1, S195). of Icelanders. The pioneers of both companies were Icelandic professors working in the USA.” (DSTI/ Services and Collaboration EAS/STP/NESTI(2004)16). The companies created a need for well educated staff and Icelanders working Opportunities Drug discovery and development is time- abroad were given a chance to come back to participate in research projects. This development has consuming and expensive. This is even more created a cluster of companies involved in life science and a growing science community. The creation evident in oncology where compounds tend to fail later in development. Iceland Genomics and continued success of companies such as Prokaria and NimbleGen Systems are an inspiration to a has developed the resources and tools with its growing number of seed companies involved in life science. established clinician network, access to cancer patients, samples and data to help pharmaceutical and biotechnology companies meet their discovery and development goals. By utilizing Population based research the inherent genetic and geographic advantages of performing R&D in Iceland, companies can expect to improve their decision-making and Biomedical researchers in Iceland agree that widespread public participation is one of the distinct accelerate the drug development process. advantages of locating such research in Iceland. Public trust in scientific research is high, perhaps due to The Icelandic Cancer Project the fact that no serious incidents involving scientific research have ever been reported in Iceland. The ICP is being carried out by Iceland Genomics The close-knit character of the Icelandic society is undoubtedly one of the factors that contribute to high Corporation in collaboration with the Icelandic rates of participation in particular research projects launched by various institutions and companies. Cancer Clinicians' Group and other participating physicians, together with the two principal People asked to take part in research projects generally respond positively. In its annual report for Icelandic hospitals and the Icelandic Cancer 2004, filed to the United States Securities and Exchange Commission, one large biopharmaceutical Registry. It aims to increase the value of the data obtained from our collection of biological firm headquartered in Iceland reports that it has gathered genotypic and medical data from more than samples, including patient DNA and tumor 110,000 volunteer participants in Iceland – over half the adult population (source: www.sec.gov). biopsies by using family information supplied 7 Although general trust towards scientific research is unusually high in Iceland, the question of centralized databanks has been widely discussed. In 1998 the law on the Icelandic Health Sector Database and a 12-year exclusive operating license sparked a lively debate and raised several issues, many of which have since been addressed by legislation and regulation concerning biobanks, data protection, scientific research, etc. (For further information see chapter on Infrastructure). Regardless of this debate, several other data registries exist in Iceland, which prides itself on its record-keeping dating back to medieval times. All Icelanders have access to a genealogical database that traces together most Icelanders 6-7 generations back. In fact, genealogy is exempt from the privacy protection law. Biobanks and registries A national healthcare system has provided universal healthcare in Iceland since shortly after World War I, giving Icelanders one of the highest life expectancies in the world. Icelandic men can now expect to live longer than men in any other country in the world. There are two major hospitals (one in Reykjavik and one in Akureyri), and there is an increasing trend towards centralization of specialist services, with a single team caring for all patients suffering from a given type of disease. This makes it easier to reach all patients in the country rapidly. Similarly, all pathology specimens have been stored in the Biobank of the National University Hospital since 1934 (which by now contains over 500,000 samples), improving the consistency of tumor reporting and classification. The Icelandic Cancer Registry dates back to 1955 and contains medical and pathological records for all patients diagnosed as by the Genetical Committee of the University having cancer since then. The Registry contains information about the site of the tumor, morphology, year of diagnosis and of Iceland and clinical information supplied age of the patient, and information on the cause of death – mostly from the pathology report. The Icelandic Cancer Society’s by the National Cancer Registry and our collaborating clinicians, so as to obtain the Molecular and Cell Biology Laboratory runs the Society’s tissue repository. world's first comprehensive survey of cancer The Icelandic Cancer Project is being carried out by privately held biopharmaceutical company Iceland Genomics Corporation across an entire nation. in collaboration with the Icelandic Cancer Clinicians’ Group and other participating physicians, together with the two principal The ICP provides patient details and clinical data which are being stored together with Icelandic hospitals and the Icelandic Cancer Registry. The ICP provides patient details and clinical data which are being stored genealogy information, genetic mapping and together with genealogy information, genetic mapping and molecular data in the IGC database. molecular data in the IGC database. The ICP also The data registry of the Icelandic Heart Association has been important in prospective heart disease studies since 1967. IHA is provides biological specimens (DNA, plasma, tumor tissue and cells from participants) now collaborating with the National Institute of Health in the USA, involving complex studies on ageing. which are stored in the IGC BioBank. Personal The data registry of the Icelandic Heart Association has been important in prospective heart disease studies since 1967. IHA is identifiers are encrypted in order to preserve now carrying out one of the most extensive phenotyping ever carried out in an epidemiology study, the Age, Gene/Environment patient confidentiality. In addition, rigorous quality control measures have been installed. Suceptibility (AGES) Reykjavik study comprising the approximately 8000 remaining men and women (now between 70 and 95 The Company is unaware of a similar resource years of age) from the 38 year long prospective Reykjavik study of around 20.000 people. The AGES Reykjavik study is largely anywhere else and maintains that the IGC funded by NIH in the US with a massive shared cost contract. database and BioBank are the world's most comprehensive clinical genomic database for cancer. Access to biobanks in Iceland The IGC database allows cross-referencing of various clinical data with lifestyle information Act on biobanks no. 110/2000 – From Section III, Art. 9: from participants, with genealogy information and with genomic information generated in the Company's own research program. This “The answerable party for the biobank grants access to biological samples for further diagnosis of diseases. He/ allows an unprecedented depth of analysis she may also grant access to biological samples for purposes of quality control, development of methods and where IGC can probe the relationship between tuition, provided that they are not personally identified. genotype, disease and clinical outcome. The The board of the biobank shall negotiate with scientists on access to biological samples. Access to biological sam- company is currently taking advantage of ples for scientific studies may not, however, be granted until the permission of the Data Protection Authority has this unique resource by searching for novel been granted on the basis of the Act on personal privacy and handling of personal data, and a research protocol cancer genes using both association studies has been approved by the National Bioethics Committee or the ethics committee of the relevant health institution, and linkage analysis. In addition, the resources as provided in the Act on the Rights of Patients and of regulations issued on the basis of the Act. built by IGC are ideal for pharmacogenomic The board of the biobank may, if approved by the Data Protection Authority and the National Bioethics Commit- studies and clinical trials. tee, authorise the use of biological samples for other purposes than those for which the samples were originally collected , provided that important interests are at stake, and that the potential benefit outweighs any potential
Growth of the Health sector within total R&D inconvenience to the donor of a biological sample or other parties.”
��
�� From Section III, Art. 10:
��
�� “The licensee shall not be counted as the owner of the biological samples, but has rights over them, with the limi-
�� tations laid down by law, and is responsible for their handling being consistent with the provisions of this Act, and % of R%D of government directives based on it. The licensee may thus not pass the biological samples on to another party, �� nor use them as collateral for financial liabilities, and they are not subject to attachment for debt. �� The licensee may take a fee for a biological sample, or access to a biological sample, equivalent to the cost of � gathering, storage and access to the sample. Any further fee is prohibited. � ���� ���� ���� ���� A biological sample may be sent out of the country in the interests of the donor of a biological sample, for diagno- Source: Icelandic Centre for Research sis or quality control. Other transportation out of the country of biological samples is subject to the approval of the National Bioethics Committee and the Data Protection Authority and on the conditions they lay down.” 8 Overview over licensed biobanks in Iceland*
Licensee Biosamples Collection of samples Registered answerable party
Tissue Archives – Department Tissue samples, including All specimens in the biobank were Vigdís Pétursdóttir, M.D. Ph.D., of Pathology, University associated clinical information, removed for diagnostic or therapeutic director of the Tissue Archives. Hospital beginning in 1935. Over 500,000 reasons. Access to tissue specimens is Landspítali – University Hospital, www.lsh.is tissue specimens from over subject to law no. 110/2000. Hringbraut • IS 101 Reykjavík • Iceland 200,000 persons. The archives Tel +354 543 8066 • Fax +354 5438349 include at least 95% of all cancer [email protected] cases diagnosed since 1955. For applications and further information please contact Jóhannes Björnsson, Professor and Chairman, Department of Pathology, tel. +354 543 8351, [email protected].
Iceland Genomics Corporation DNA, plasma, tissue and cells Samples are collected with informed Dr. Med. Þorvaldur Jónsson www.icelandgenomics.com from cancer patients, relatives consent from volunteers for genetic Iceland Genomics Corporation and controls. These specimens are research and personal identifiers are Urður Verðandi Skuld associated with medical history, encrypted in order to preserve patient Snorrabraut 60 • 105 Reykjavík epidemiology and pedigree confidentiality. Iceland information. Tel +354 525 3600 Fax +354 525 3608 [email protected]
Icelandic Cancer Society The Icelandic Cancer Society’s Samples are collected from individuals Helga M. Ögmundsdóttir, M.D., www.cancer.is Molecular and Cell Biology receiving diagnoses of cancer Head of the Molecular Biology Division, Laboratory runs the Society’s or suffering from cancer-related Icelandic Cancer Society biobank. It contains blood samples, diseases. P.0. BOX 5420 serum, red blood cells and live IS 125 Reykjavík • Iceland white cells, DNA and tissues. Tel +354 540 1900 Fax +354 540 1910 [email protected]
Icelandic Heart Association Biosamples from IHA research Samples are taken from participants Vilmundur Guðnason, M.D., Ph.D., Director Research Institute programs. The biobank is based on in IHA research projects, based on Icelandic Heart Association www.hjarta.is IHA prospective studies dating back informed consent. Holtasmára 1 to 1967. IS 201 Kópavogur • Iceland Tel +354 535 1800 • Fax +354 535 1801 [email protected]
deCODE Genetics Inc. Blood-derived products (such as Samples collected with consent from Kári Stefánsson, M.D., Dr. Med., President, DNA and serum) from over 110,000 volunteers, for use in the company’s CEO and Director individuals. genetic studies. deCODE genetics Sturlugata 8 • IS-101 Reykjavik • Iceland Tel +354 570 1900 Fax +354 570 1903 [email protected]
Tissue Diagnostics Laboratory Over 100,000 tissue samples Pathology specimens are sent to Kristrún R. Benediktsdóttir, M.D. (Vefjarannsóknarstofan) this independent service clinic for Vefjarannsóknastofan diagnostic purposes and stored Álfheimum 74 for possible further research in the IS 104 Reykjavik interest of the patient. Iceland Tel +354 588 7711
*Licensed by the Icelandic Ministry of Health and Social Security under Act no. 110/2000 on Biobanks and listed by the Icelandic Directorate of Health in June 2005 (Source: www.landlaeknir.is). Number of licenses is expected to increase.
9 The extreme nature as a resource
Gene-mining at new frontiers Iceland’s geothermal areas foster amazing microbial biodiversity, including submarine thermophile bacteria yielding unique enzymes which open new possibilities for research, industry and medicine.
Iceland has been called the land of contrasts – the island of ice and fire. Iceland sits astride the middle of the Mid-Atlantic Ridge – a 10,000-mile crack in the ocean floor caused by the separation of the North American and Eurasian tectonic plates. On average, Iceland experiences a major volcanic event once every 5 years. A third of all the lava that has covered the earth’s surface on dry land since the Middle Ages has erupted in Iceland and the country is richer in hot springs and high-temperature activity than any other in the world. Prokaria The same geological activity that creates the volcanoes provides an endless supply of geothermal energy. www.prokaria.com Prokaria is a biotechnology company that uses Over 90% of housing in Iceland is heated by natural geothermal heat – one of the cheapest and cleanest proprietary ecological genomics methods and forms of energy in existence. Hot springs can be found almost everywhere, and the melt water created bioinformatics to directly discover novel genes by sub-glacial volcanoes provides the country with a huge potential source of sustainable hydroelectric in nature. We provide access to the Icelandic bio- sphere in terms of geothermal biodiversity. In or- power. This energy contributes to keeping pollution at a minimum. More recently the geothermal areas, der to develop new catalysts and small bioactive including submarine ones, have been researched for their amazing biodiversity which is a source of molecules we combine in silico and in situ screen- valuable enzymes. Iceland is now home to a world-leading company in the development of thermophilic ing to discover and develop new applications for enzymes. research, industry and medicine. In addition to developing our own products for research and The North Atlantic ocean surrounding Iceland is another valuable natural resource, being on of the diagnostic products we offer services in environ- world’s richest and least polluted fishing grounds and the traditional mainstay of the Icelandic economy. mental genomics and genotyping of fish. The cleanliness and wholesomeness of Icelandic seafood products are all-important. Another key factor
Thermophilic enzymes in maintaining a sustainable fisheries industry, an important part of Icelandic policy, is the development In commercial applications enzymes will play a of processes and products that increase the value and utilisation of marine harvests. Icelandic companies major role in the economic growth of the en- are now using biotechnology to develop new valuable products from this resource. vironmental cleanup that will take place in the 21st century by replacing many of the synthetic catalysts currently used. Thermostable enzymes have an application range unparalleled by other Thermophile bacteria biocatalysts and are therefore opening up new applications. As a result of natural evolution Thermophile bacteria, i.e. bacteria living in and around geothermal vents in marine or aquatic they are more robust and active under extreme environments, provide novel genes and/or enzymes which may be utilized for various purposes. Iceland conditions. The demand for new enzymes, drugs and other provides a unique opportunity for research and development within this field. products from biotechnology is rapidly increas- Prokaria is an Icelandic company which has already discovered and developed novel thermophilic enzymes ing and enzymes will play a major role in genetic with highly unusual characteristics. The company provides access to the world’s most diverse and active disease diagnostics, in synthesis of new pharma- ceuticals and in new drug applications. geothermal area. Prokaria's customers operate within the fields of fine chemicals, food & feed, R&D and In order to best cover the demands and chal- diagnostics, cosmetics, petro-oil and fish breeding. Prokaria’s partners include Nestlé, Novartis Animal lenges of the future, Prokaria is organized and Health, Wacker Chemistry, Roquette and Novozymes. equipped to offer a fully integrated set of serv- ices from tissues to protein productions.
Marine products
A report compiled for the Ministry of Industry in February 2002 discusses the possibilities of using biotechnological innovation for creating more value within the fisheries industry. In 2002 the Ministry of Fisheries established a fund to promote projects that increase the value of catches from the marine environment. A part of the fund is dedicated to biotechnology. This interest in increasing catch value, the importance of the marine industry in Iceland and the wealth of useable material available make Iceland an attractive option for companies specializing in this promising field. Most of the companies operating within this field are engaged in active international collaboration. Their projects include the development of various products based on, for example, lipids, minerals, chitin and various proteins and enzymes originating from marine organisms. Two companies have been founded based on research into cold-active (psychrophilic) enzymes and their industrial applications in pharmaceuticals, cosmetics and the food industry. Primex Ltd. is a marine biotechnology company which is now among the largest suppliers of chitin- derived biopolymers in the western hemisphere, and actively involved in development projects focusing 10 on advancing chitin-based technologies into various fields of applications, such as materials, cosmetics and biomedicine. Concentration of people Lysi Ltd., established in 1938 to satisfy the demand for vitamins A and D by developing and marketing cod-liver oil, has been building on more than 40 years of research to become one of with high level know-how the foremost companies in research and product development involving marine oils and their utilization. The main focus has been on studying Omega-3 polyunsaturated fatty acids (PUFAs) “For us it was natural to locate in that could help prevent and treat a wide range of diseases. This work has been carried out in Iceland due to the natural geothermal resources and the human talents that close cooperation with leading international pharmaceutical firms and research organizations. we built the company on. Further, our relationship with deCODE genetics was vital for us in the start-up phase Selective breeding of fish and we have benefited greatly from their help by having access to the best Abundance of clean spring water, geothermal water for heating, and unpolluted ocean makes facilities and equipment in this field in the world as well as their experience Iceland attractive for fish breeding. Aquaculture is a growing industry which demands increasingly and knowhow. Also, the high educa- advanced technology. Genetic research is now being used in selective breeding of fish. tional level, the strong economy, the Prokaria Ltd. has extended its service to include molecular services in environmental genomics proven build-up of many high-tech companies in different sectors and the and in applied genetics and breeding of fish. Genotyping, the analysis of DNA for specific entrepreneurial spirit here are defi- gene markers, has extensive uses in parental analysis for breeding of animals and fish as well nitely positive elements, as is the con- as for tracing the origin of foodstuffs, detecting GMO in food and feed and monitoring and siderable concentration of people with high-level knowhow in IT, biomedical management of wild stocks. Using its high-throughput robotics laboratory. Prokaria genotyped and biotechnology-related areas.” 10,000 individuals of salmon for the world-leading fish breeding company Stofnfiskur hf. in just two months. Prokaria has recently started genotyping other species of fish including cod and Jakob K. Kristjánsson, halibut, as well as domestic animals. President and CEO of Prokaria
11 The climate and environment as a resource
Molecular Pharming in a safe environment Iceland’s environment and climate enables pesticide-free agriculture and horticulture with ideal, automatic in-field con- tainment of many transgenic plants. Renewable geothermal and hydroelectric energy makes Icelandic greenhouses ideal growth chambers.
Iceland’s climate is temperate and oceanic, influenced by the country’s location where the polar front separates air currents of polar and tropical origin. The weather is affected also by the confluence of two ocean currents: the Gulf Stream flowing clockwise around the south and west coasts, and the East Greenland polar current curving southeastwards round the north and east coasts, which meet off southeast Iceland. The average summer temperature in Reykjavik, the capital, is 10.6°C/51°F in July, with average highs of 24.3°C/76°F. In environmental terms, Iceland is unique. Iceland is a large country (103,000 km², about the same surface area as Ireland or the State of Virginia), but sparsely populated, with only 3 persons per km², living mostly along the coast. The interior is largely an arctic desert, punctuated with mountains, ORF Genetics glaciers, volcanoes and waterfalls. Most of the vegetation and agricultural areas are in the lowlands www.orfgenetics.com close to the coastline. ORF Genetics generates solutions for bioproduc- These conditions enable Icelandic agriculture to market unpolluted products and open new possibilities tion in higher plants. The company’s customer services range from provision of rare research in biotechnology where purity is all-important. proteins to production projects of recombinant proteins, in-field or in green houses, utilizing barley as production host. A combination of economic, biological and ag- Molecular Pharming – containing transgenic plants ricultural features in Iceland supports a unique The production of recombinant proteins in transgenic plants for the pharmaceutical industry is often cost-effective and long-term reliable bioproduc- tion: referred to as molecular “pharming”. ORF Genetics uses its proprietary technology to harvest from • Automatic containment of transgenic barley the unique features found in Iceland such as the exceptional purity left by the negligible application of in an in-field cultivation due to its self-pollina- agrochemicals. Pesticides and herbicides have never been used for outdoor agriculture and fungicides tion and absence of endemic wild-type relatives • Abundance of immediately available farm- only rarely. This situation, unique on a global scale, is important for guaranteeing the purity of the land for barley, embedded in a fully developed pharmaceutical proteins produced. infrastructure ORF Genetics has focused on barley as a production system since barley provides built-in biological • Abundance of inexpensive energy to heat and illuminate greenhouses around the year containment and in Iceland it could not survive outside cultivated fields or cross-pollinate, since there • State-of-the-art production and develop- are no plants related enough in the Icelandic flora. This provides an ideal automatic containment which ment facilities for plant biotechnology provided is of vital importance for any plans to produce recombinant proteins on a large scale. by ORF and associated R&D organization In addition, Iceland has extensive, remote tracts of unused, arable land where barley could be cultivated, • ORF is supported by society and government We understand that our customers in the phar- with the potential of a massive production capacity for recombinant proteins. The country’s surface area maceutical industry or in the fine chemicals mar- is 103,000 square kilometers (40,000 square miles), of which arable land constitutes 15% or 1.5 million ket strive for their proteins to be manufactured hectares (ha.), including 750 thousand ha. suitable for raising barley. ORF projections call for growing in an efficient system that is devoid of inherent limitations, not only during development (the transgenic barley on six thousand ha. within 10-15 years, which is only about 1% of the presently short term) but also during full-scale production available land (www.orfgenetics.com). after entering the market (the long term). In ad- dition, we have designed our system to be cost- competitive for our clients, even after patents expire and generics join the market. Growth chambers – controlled environment The pharmaceutical business is the primary tar- get, although other industry, agriculture, the Production in greenhouses is a special characteristic of Icelandic agriculture and there are almost 200,000 R&D sector and further markets will be served square meters of cultivation under glass. Greenhouse culture is based on abundant and inexpensive as well. geothermal water and steam, used both for heating and illumination by electric lights. Greenhouses are ideal growth chambers where the whole environment can be controlled. ORF has announced that it intends to take advantage of these facilities for a rapid scaling-up of its production of each barley cultivar, i.e. production of seed stock for outdoor cultivation. Some of ORF’s proteins will be produced entirely in greenhouses.
12 The advanced health industry as a resource
Life Science in Iceland
With R&D expenditure of over 3% of GDP, an advanced healthcare system, expertise in harvesting from the riches of natural resources, technical sophistication and a positive business environment, Iceland has experi- enced rapid growth in the life science and medical technology sector.
Important fields within the life science sector in Iceland are based on the research tradition within the Icelandic healthcare and educational system. The Icelandic healthcare system is based on the successful Scandinavian model with high-quality public hospitals. Apart from Molecular and cell biology research laboratory at the Icelandic Cancer Society general longevity, infant mortality is one indicator of how advanced the healthcare system in www.cancer.is general is, and the average for 2001-2003 reveals an infant mortality rate of only 2.4 per 1,000 The Icelandic Cancer Society is a nationwide, voluntary live births, lower than in any other country in the world (www.statice.is). organization. Research in cancer epidemiology has been one of the functions of the Icelandic Cancer Society since the Landspítali University Hospital and the FSA University Hospital in Akureyri are general emergency Cancer Registry was started in 1955. One of its main long- and specialized teaching hospitals involved in extensive research cooperation. The University term projects has been the study of families of patients with breast cancer. This study is now quite extensive and has Hospital in Reykjavik has a good reputation in many important fields such as orthopedics, been facilitated by favourable conditions in Iceland such as cardiology, bariatric surgery and thorasic surgery. Alongside the hospitals, doctors run private good public records and a general interest in genealogy. The information thus collected is extremely valuable and forms clinics or research and diagnostic companies. Some clinics have joined forces with other in many ways the foundation of the research laboratory. medical companies or SPA facilities to form medical centers offering specialized services, even The Molecular and Cell Biology Research Laboratory at the Icelandic Cancer Society was established in 1987. The abroad. Organizations such as the Icelandic Cancer Society and the Icelandic Heart Association laboratory has two main functions: 1) The collection, operate research centers and detection clinics and accumulate valuable databases. processing and keeping of a bank of biological specimens and 2) basic research on cancer. The biological specimen Taking advantage of the close-knit Icelandic society and cooperation between hospitals, bank is intended to provide material for research. research institutions, university departments and the industries, Icelandic entrepreneurs and The main focus has been on breast cancer in general and hereditary breast cancer in particular. The ICS laboratory scientists have founded important companies and research projects which have contributed to played an active part in an international effort in search of enormous growth in the life science sector, e.g. in the pharmaceutical industry. the breast cancer susceptibility genes, BRCA1 and BRCA2, and found an Icelandic founder mutation in the latter in Innovation is the driving force behind Icelandic health technology. A highly educated 1996. This has formed the basis of several large projects workforce with an international outlook, combined with an entrepreneurial environment and with Icelandic and international collaborations. Hereditary breast cancer: The major focus is on molecular a sophisticated healthcare system, make the country an ideal place for developing and testing epidemiology of breast cancer which includes population- cutting-edge health technology innovations. The rapid growth of Icelandic companies in this based studies on the effects of mutations in the BRCA1 and BRCA2 genes and environmental factors on breast cancer field bears witness to these advantages. Turnover in health and biotechnology grew by over risk. We are also doing expression profiles in breast tumors 123% between 1999 and 2001. (DNA expression arrays in collaboration with Nimblegen Systems Iceland, tissue arrays in collaboration with the Dept. of Pathology, University Hospital and proteomics in collaboration with the Icelandic Heart Association) related High technology research hospital to genetic and epigenetic changes and clinical factors. We have ongoing research projects in genomic instability and Iceland’s Landspítali -University Hospital (LUH) is a tertiary care hospital that serves the whole DNA repair, making use of advanced technology such as live cell imaging and COBRA analysis. This is highly relevant of the country but mainly the residents of the capital city, Reykjavik, and surrounding areas. as studies show potential application for BRCA-directed The population of Iceland is roughly 290,000 of which 178,000 live in Reykjavík and suburban drugs. Finally, we are doing risk assessment and prognostic significance of BRCA2 mutations in breast and prostate areas. cancer. The hospital is at the forefront for specialized and general healthcare in Iceland, and is the Screening of natural compounds for anti-cancer activity: One third of current drugs are derived from nature. The central knowledge base for service and education of healthcare professionals. It has a strong current search for new compounds focuses in particular connection with the University of Iceland, especially after a cooperation agreement in 2001. on previously unused sources such as primitive plants and marine organisms. We have identified several small Bilateral and mutual institutional goals have been set for the aims of the hospital and the molecules from lichen that have inhibitory effects on the university and use of specialized knowledge and materials. Cooperation takes place on growth of certain types of cancer cells. Some of these institutional aims, human resources, organization of academic studies in the hospital, and basic substances also inhibit the activity of lipoxygenases, known to be involved in inflammation but also important for the and developmental research and teaching programs for shared employees and the public. growth and survival of many cancer cells. Preliminary data Over 1100 students a year are trained at the hospital and almost all medical students in Iceland on screens of substances from marine organisms living in the cold sea around Iceland have identified cell growth receive their training at LUH. inhibitory activity. In 2004 there were 33 PhD studies in progress at the hospital, in different specializations. Also, Stem cell research: Stem cells are important for growth, differentiation and branching morphogenesis of the 59 individuals were studying for their MSc. human breast gland. It has become clear that in order to An increasing number of foreign students receive clinical training at the hospital – a total of understand the complex cellular and molecular interaction that occurs in vivo, it is important to study cells in three- 58 in 2004, of which 44 were medical students. Foreign students come mainly from Germany, dimensional context. By utilizing a sophisticated three- the UK and Scandinavia. dimensional (3D) cell culture assay our aim is to study the cellular and molecular pathways that can modulate breast Approximately 450 employees are doing research, full-time or part-time, from a total staff of morphogenesis. Defining molecular signaling responsible around. 5000. Researchers are working in cooperation with companies and research institutes for branching morphogenesis in the normal breast gland is a prerequisite to understanding how morphogenesis is all over the world. Funding is provided from sources including from the National Institutes of subverted when cells become cancerous. Health in the USA and Europe and the Pasteur Institute in France. 13 Landspítali – University The hospital also funds research. In 2005, $ 781,000 was allocated to the hospital’s employees Hospital for that purpose. For further information on research at the At LUH the research emphasis is both basic and clinical, in addition to developmental research. Landspítali University Hospital or contact The bulk of research is clinical. An estimated 400 scientific projects are ongoing at the hospital. information for laboratories, research Most researchers are medical doctors but other professions are increasingly doing research. projects and individual scientists please The research environment is favourable and the index rate of papers produced in Iceland in contact The Office of Education, Research scientific journals is very high. The hospital’s employees published 167 articles in scientific journals and Development, Department of Research Services, Landspítali – University Hospital, C- in 2003 and 154 in 2004. 13 Fossvogur, IS – 108 Reykjavík, Iceland. Fax At the hospital there is a medical library that serves clinical staff and researchers as well as the +354 543 2339. Oddný S. Gunnarsdóttir, head Medical and Nursing Faculties of the University of Iceland. In May 2005 the library subscribed to of department, [email protected], tel approx. 4000 electronic journals and some 90+ E-books, covering all fields of specialization at +354 5431470. Sigurlaug Sveinbjörnsdóttir, the hospital. The library uses link resolvers to link from databases to its e-journals. head of department, sigurlaugs@landspitali.
is, tel +354 5435711 Biomedicine
The Icelandic pharmaceutical industry has been gradually developing since the last century. The first patenting law, established in 1923, prohibited patenting of medicaments, but this changed Research infrastructure is with new legislation from 1992. In 1981, Delta Ltd. was founded to exploit the opening of in place generic drugs for the local market. The company expanded into the international market as did other pharmaceutical companies such as Pharmaco, which bought Balkanpharma of Bulgaria “Biomedical research has gained an ex- in 1999 and thus became a significant player in the international market for generic drugs. In ceptionally strong foothold in Iceland in July 2002, Pharmaco acquired a majority share in Delta before the two firms merged under the the past few years. Research infrastruc- ture is in place and a relatively large name Pharmaco, later Actavis Group, thus creating the single largest firm in Iceland. Actavis number of highly qualified specialists is today an international company employing highly capable professionals, with expertise and in fields relating to this area are found production capacity competitive with the world’s largest producers of generic pharmaceuticals. in Iceland, both at private and publicly Headquartered in Iceland, the group currently operates across five continents with a workforce funded institutions.” of around 7,000. One example of a successful biopharmaceutical R&D company originating from the University of Þórunn Rafnar PhD (Director of Cancer Research), Iceland Faculty of Pharmacy is Lyfjaþróun - Biopharmaceuticals. This company was established Iceland Genomics Corporation to continue pioneering work in developing vaccines and medical treatments and focused its research on utilizing the immunological side-effects observed in sequence to nasal peptide and protein delivery. The company has been granted a number of international patents and has made significant progress in advancing the technology for vaccination and drug delivery by the intranasal route. More examples of innovative companies in the field of biomedicine can be found in the list of corporate websites in this publication. Development has also taken place in drug development and clinical testing, both through Icelandic companies and international companies launching specific clinical tests in Iceland with Icelandic physicians as collaborators. There is no doubt that the high levels of participation make clinical testing in Iceland an attractive proposition.
Stem Cell Research ������������������������ ������������������� ������������ ����� ���� ����
����� Stem cell research is of growing importance in Iceland and several research institutions are ����� involved in stem cell projects. The distinguished WiCell Research Institute, directed by Dr. James Thomson, is undoubtedly the best known. Dr. Thomson directed the group that reported the ��� first isolation of embryonic stem cell lines from a non-human primate in 1995, work that led his ������� ����� ���� group to the first successful isolation of human embryonic stem cell lines in 1998. WiCell made
���� ������������� a cooperation agreement with Nimblegen Systems, Iceland, on running a laboratory for stem ���� ���� cell research in Reykjavik. Wicell chose Nimblegen for its pacesetting, advanced technology in 14 this field. Nimblegen has developed microarray technology to speed the research discovery process. The Blood Bank of the University Hospital has for years been conducting ambitious research on human umbilical cord blood stem cells and bone marrow. In cooperation with the University Hospital’s Faculty of Hematology, stem cells have been used clinically to treat malignant hematological disorders. The University of Iceland’s Department of Biochemistry and Molecular Biology has started research focusing on mouse embryonic stem cells and the regulation of their differentiation fate. The Icelandic Cancer Society’s Molecular and Cell Biology Research Laboratory has been focusing its research on stem cells because of their importance for growth, differentiation and branching morphogenesis of the human breast gland. Utilizing a sophisticated three-dimensional (3D) cell culture assay, the aim is to study the cellular and molecular pathways that can modulate breast morphogenesis. Defining molecular signaling responsible for branching morphogenesis in the normal breast gland is a prerequisite to understanding how morphogenesis is subverted when cells become cancerous. Embryonic stem cell research is not prohibited in Iceland, but therapeutic and reproductive cloning are. See the chapter on infrastructure for further information.
Lindgen – Cold Spring Harbor Medical devices Laboratory www.lindgen.is Close cooperation between research and development companies and major hospitals like the LindGen in Iceland is a genetic analysis service University Hospital in Reykjavik is important for the medical devices industry. Here, as in other provider fully owned by Cold Spring Harbor fields, this compact market and research community creates the ideal environment for product Laboratory (CSHL). CSHL is a leading institution for biological research and education in New development and testing while the location between two of the world’s largest markets and York. CSHL has research programs in cancer, fast and easy access to major cities worldwide makes Iceland an attractive site for companies neurobiology, plant genetics, genomics and with global ambitions. Iceland is ranked as the world’s second most successful economy in bioinformatics and a broad educational mission. LindGen uses Representational Oligonucleotide exploiting developments in information and communications technology according to the Microarray Analysis (ROMA), a methodology Global Information Technology Report 2005 published by the World Economic Forum. developed by Michael Wigler at CSHL to detect In the last few years increasing interest has been directed towards developing information genetic lesions in cancer patients, normal individuals and patients with inherited genetic technology for healthcare organizations in Iceland. This software development is focusing disorders. LindGen and CSHL are part of a on recoding and keeping track of complex data flow, patients and their treatment and use broader consortium of research and educational of medicament within healthcare organizations. Some Icelandic companies have more or institutions aiming to introduce genetic analysis less started as research projects using the Icelandic healthcare system as its development into routine clinical practice, thus improving therapeutic decisions and disease outcome for platform. patients with genetic diseases. Today, certain Icelandic companies are leaders in their field. Ossur Ltd. is one of the world’s Scientific director of LindGen is Professor Michael leading international companies in prosthetics and orthotics R&D and manufacturing. Oscar’s Wigler and Manager is Eirny Thorolfsdottir (MSc). Rheo Knee, an electronically controlled prosthetic knee joint featuring artificial intelligence, was
chosen one of “the world’s coolest inventions of 2004” by Time Magazine. Ossur operates in nine locations across the globe. ���������������������������������������������������� Medcare, a subsidiary of Flaga Group, Iceland, is one of the global leaders in the development, �����������������������������������
manufacture and sale of sleep diagnostic systems – and in fact the only company in the medical ���
device industry that is entirely focused on sleep diagnostics. ��� Kine was founded in 1996 by three engineers working together at the National Hospital and ��� the University of Iceland. Kine develops and markets new solutions and diagnostic equipment ��� for the analysis of movement. ��� Taugagreining, which developed a revolutionary technique for brain diagnosis, was recently acquired by VIASYS Healthcare Inc., a global market leader in healthcare technology. NicoletOne, ���
� the new modular neurodiagnostic system from VIASYS Healthcare’s Neurocare group, is based ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ����
on the pioneering work of Taugagreining. Source: Icelandic Centre for Research
15 The infrastructure as a resource
The best of both worlds Located on top of the Mid-Atlantic Ridge, Iceland spans geologically both Europe and North America – and perhaps culturally too, combining the European emphasis on the welfare system with the North American belief in entrepreneurship and individual freedom.
Education, technological infrastructure, social framework and positive attitudes and values have been among the factors ensuring Iceland continually higher rankings among the world’s most competitive nations according to recent IMD World Competitiveness Yearbooks. Qualified employees are important for technology companies operating in Iceland. The educational system and institutions have opened up new fields offering more diverse and extensive educational possibilities in IT, engineering, biotechnology, business, etc. Major investments have been made in telecommunications networks and services in Iceland in recent years. The system ranks with the most sophisticated anywhere. The infrastructure has undoubtedly supported the fast adoption of technological solutions throughout society.
The growth of Life Science in Iceland
Rapid expansion has taken place within the health industry and biotechnological Gross domestic expenditure on R&D sectors in Iceland in the past decade, in line with the trend within other science
3,50 and technology sectors.
3,00 In a recent report, the Icelandic Center for Research (RANNIS, April 2003) estimates that 2700 man-years were spent on research and development. 2,50 Papers by Icelandic scientists have increased steadily (figure 1), and according 2,00 Iceland United States to the same report by RANNÍS, the largest field by far in this respect comprises OECD 1,50 EU the health sciences.
1,00 Filing of patents is regarded as an important estimate of general innovation in
0,50 developed countries. Applications to the Icelandic Patent Office have increased significantly during the past decade. From 1994-1997 Icelandic entities applied 0,00 ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� for 20 patents, whereas in 2004 applications were 65. Patent applications to the US and European Patent offices have also proliferated. The strongest technological fields of Icelandic activity in Europe are pharmaceuticals, medical Midway between North technology, machines and apparatus for agriculture and technology for measurement and analysis. Some America and Europe and a 45% of all Icelandic applications in Europe are in these four fields. closely knit society Looking specifically at the health industry and biotechnology sectors, turnover in the health industry sector increased year-on-year by 36% in 2000. The number of personnel employed within the sector was approx. 500 in 1997 but had tripled in 2000, rising to around 1500 employees. “Iceland is a very good location for the research and manufacturing facil- ity of NimbleGen Systems, because it is midway between North America and Education and research institutions Europe and our partners and customers are on both sides of the Atlantic. The Three educational facilities offer courses at graduate levels applicable to the biomedicinal and biotechnological closely knit Icelandic society provides sectors. Two universities offer graduate programs, but because these are relatively recent, most Icelandic us with easy access to other scientists scientists today have gained their graduate qualifications abroad. It is recognized that one of the main and technicians and we can often solve problems in an easier and simpler way strengths of the Icelandic scientific community is the extensive net of international connections arising from and than in larger societies.” maintained by researchers who have completed advanced research degrees in other countries. Their variegated background benefits the scientific community: the different emphases of different graduate programs serves Sigridur Valgeirsdottir, to diversify scientific discourse in Iceland and also opens unique opportunities for cooperation. Ph.D., NimbleGen Systems Iceland At the University of Iceland, Reykjavík, four departments offer degrees applicable to research careers within the biomedicinal and biotechnological sectors. All four offer graduate programs at the Masters level and three offer Doctoral programs. At the University of Akureyri, two faculties offer programs aimed at research: the Faculty of Health Sciences and the Faculty of Natural Resource Sciences, which includes Aquaculture, Biotechnology, Fisheries, and Environmental Studies. 16 At the Technical University of Iceland, the Faculty of Health Sciences offers programs relevant to biomedicine and biotechnology, including programs in Biomedical Science and Diagnostic Radiography which focus on practical vocational training for future employees of research institutions and companies. Several research institutions operate in Iceland, many affiliated to the University of Iceland and/or Landspítali University Hospital. A few large independent research institutions also conduct research within extensive international frameworks. The website of the Icelandic Center for Research, www. rannis.is, publishes an updated list of research institutions in Iceland. Some of the most important ones in Life Science are listed in this publication, along with the corporate websites.
The Icelandic Heart Association and the Investment in Research AGES study www.hjarta.is According to the OECD, Iceland increased its allocation of funds to scientific research and development from just over 1% of GDP in 1991 to more than 3% in 2003. By reaching the 3% The Icelandic Heart Association is a non profit, charitable organization running its own Research mark, Iceland met the target that the EU has set for attainment by 2010. Growth is mainly due to Institute for nearly 40 years. It conducts studies input from the private sector, rising from 25% in 1991 to 46.2% of total input in 2003 with the in genetic and conventional epidemiology, family establishment of a number of research-based companies in the past decade. Public funding of based genetic studies, clinical trials, as well as run- R&D in Iceland is proportionally among the highest in the world. ning cardiovascular risk factor clinic in collaboration with a number of cardiologist and endocrinologists. According to Eurostat’s latest R&D statistics – covering the EU-25 countries, the candidate Currently the IHA is establishing an outpatient clinic countries, China, Japan and the US – Iceland ranks number 3 along with Japan in total R&D in hyperlipidaemia, diabetes and hypertension. intensity. R&D expenditure in the business enterprise sector in 2002 was 1.8%, ranking Iceland At present the IHA is carrying out one of the most extensive phenotyping ever carried out in an epi- with the European top 5. demiology study, the Age, Gene/Environment Su- The division of research effort between the public and private sector has been changing. Of the ceptibility (AGES) Reykjavik study comprising the 2700 man-years spent on research and development in 2001, two-thirds of this investment was approximately 8000 remaining men and women accounted for by the private sector and one-third by public funding. (now between 70 and 95 years of age) from the 38 year long prospective Reykjavik study of around In the past decades the share of research and development conducted by official research institutions 20.000 people. The hallmark of the current study is has fallen from around 70% to 20% of total research undertaken in Iceland. Interestingly, the the use of extensive imaging, such as CT, MRI and research effort within the University sector has increased. This change in the background of ultrasound in conjunction with extensive cogni- tive, cardiovascular, bone and body composition funding is reflected in changes of emphasis within the research sector. Less emphasis has been examination. The AGES Reykjavik study is largely given to research within the basic industrial sectors – fisheries, agriculture and energy – while funded by NIH in the US with a massive shared cost research within the fields of technology, health and medicine has grown substantially. Today, contract. The current number of employees is about companies in human genetics, biotechnology and pharmacological research account for by far the 85 people. The IHA is seeking further collaborative projects largest share of R&D in Iceland, according to the Research Council. with both non-profit and with commercial entities Support may extend beyond direct funding. Cooperation between institutions and companies to take forth findings as well as making use of its provides an incentive for research, as does the growing emphasis on graduate training within the vast resource for phase II studies in various areas. university sector.
Iceland´s most cited research papers by field (1993-2003)
Clinical medicine
Geosciences
Molecular biology & genetics
Plant & Animal science
Pharmacology & Toxicology
Biology & Biochemistry
Physics
Immunology
Microbiology
Agricultural Science
0 2000 4000 6000 8000 10000 12000 14000 16000
Source: ISI Essential Science Indicators
17 The Legal framework and patents
Several separate laws provide a formal framework for science- and technology-based activities in Iceland. The most recent legislation addresses funding and support for scientific research and innovation, and reflects the growing understanding among policymakers of the underlying need to create a modern, diverse economic base for society.
NimbleGen Systems of Iceland, LLC The science laws www.nimblegen.com In 2003 three acts were established, collectively termed the “Science Laws”: Act no. 2/2003 on NimbleGen Systems, Inc. develops DNA the Science and Technology Council; Act no. 3/2003 concerning Official Support of Scientific microarray and chemistry technologies, providing Research; and Act no. 4/2003 concerning Official Support of Technological Development and the highest density arrays available in the Innovation in the Interest of Industry. The main purpose is to establish a formal framework and industry in a fraction of the time of conventional microarrays. The company’s patented Maskless support environment for scientific and technological research and development. Array Synthesizer (MAS) technology provides The explosion in genomic and familial research in Iceland prompted a radical update of Icelandic highly customized oligonucleotide array design, legislation, culminating in a legislative framework that in some ways is internationally paceset- manufacture, hybridization and analysis services to researchers in biotechnology, pharmaceuticals, ting, although in other ways it has been controversial. government and universities. NimbleGen’s The June 2004 report “Iceland’s Research Resources: The Health Sector Database, Genealogy products and services aid researchers in high- Databases, and Biobanks”, prepared by the Office of Science Policy, National Institutes of Health, throughput, low-cost screening for genotyping, USA, outlines the laws and regulations most relevant for foreign scientists wishing to cooperate gene express analysis and toxicity screenings. NimbleGen is a spin-off of the University of with Icelandic researchers or use Iceland’s resources in their own work. Wisconsin – Madison and retains several patents on its unique technology. The company draws Data protection and privacy on technical expertise from molecular biology, The Data Protection and Privacy Act no. 77/2000 aims at the protection of personal informa- genetics, organic chemistry, clinical pathology, engineering, physics and bioinformatics services tion in accordance with basic principles and rules of personal privacy, as well as guaranteeing gained through experience with industry the reliability and quality of such information and its free passage in the inner market of the leaders. EEA. In accordance with this act, the Data Protection and Privacy Agency (www.personuvernd. NimbleGen Systems of Iceland, LLC, is located is) was established in 2000, replacing the previous Data Protection Committee. All research utiliz- in Reykjavik. The laboratory is designed and built to perform custom array manufacturing ing sensitive personal information such as health statistics, hospital records, genetic or familial services for academic and corporate customers information, etc. must be designed in accordance with the rules of the DPPA. who prefer to outsource either all or a portion of The current Act on Patient’s Rights, no. 74/1997, established the jurisdiction of the National their DNA microarray needs. The Iceland service Bioethics Committee. It was later elaborated on with Regulation no. 552/1999. Three institutional laboratory, in coordination with NimbleGen’s custom DNA array design service, utilizes the ethics committees are defined in the regulation, within the University Hospital, the (regional) inherent characteristics of the NimbleGen MAS FSA University Hospital and the healthcare service. No scientific research is permitted within the platform to provide high-density, high-quality health sector without the approval of one of these ethics committees, which each has its own DNA arrays and related services faster and more economically than competitors. To date jurisdiction. Evaluation of the research proposal must have revealed that there are no scientific the services facility has successfully executed and/or ethical grounds to oppose its implementation. DNA array synthesis, sample hybridization, slide Regulation no. 284/1986 on Pharmacological Clinical Trials is concerned with the rights of scanning and data transfer to biopharmaceutical participants in such trials and correct experimental design. and academic customers in North America, Europe and Asia. NimbleGen Systems has signed cooperation Biobanks and the Icelandic Health Sector Database agreements with research groups in USA, Act no. 110/2000 on Biobanks sets the framework for the operation of biobanks with regard to where the research group can work directly both research and clinical samples. By law, all samples stored for more than 5 years must be stored with experienced scientists at the Nimblegen facility in Iceland. This program, Nimblegen in a biobank that has been licensed by the Ministry of Health and Social Services. Research may Direct, allows efficient research service without not be conducted on samples without the approval of the National Bioethics Committee, and laboratory setup or scientist training on behalf normally all research incorporating genetically based research must be based on informed con- of the customer. sent. Samples obtained for research purposes must be obtained with informed consent, whereas clinical samples are stored under assumed consent, with the provision that the sample provider be informed of its storage and given an opportunity ������������������������������������������� to deny any use of his or her sample for research purposes. Regulation 8.000,0 no. 134/2001 further specifies the management of legally established 7.000,0 1990 biobanks. 6.000,0 1991 1992 The objective of Act no. 139/1998 on a Health Sector Database is to author- 5.000,0 1993 1994 ize the creation and operation of a centralized database of non-personally 4.000,0 1995
Millions of ISK identifiable health data with the aim of increasing knowledge in order to 1996 3.000,0 1997 improve health and health services. Since the centralized database has not 1998 2.000,0 1999 yet been launched, no experience has been acquired on the law’s applica- 2000 1.000,0 2001 bility. Other legislation on several officially maintained health databases 0,0 2002 ���������������������� ������������������������� is pending.
18 Biotechnology Comprehensive legislation on the biotechnology industry in Iceland has not yet been passed. A general Act on the Utilization of Terrestrial Resources was passed in 1998 (57/1998), but does not address the question of biotechnological utilisation specifically. Article 34 of the Act incorporates the utilization of thermophile micro-organisms into this legislation. Utilization of thermophile micro-organisms is regulated by the Ministry of Industry under Regulation no. 234/1999, which establishes a framework for licensing research on and utili- sation of micro-organisms found in the geothermal areas in Iceland. The Regulation is also intended to secure supervision of research and utilization, as well as ensuring conformity with the International Convention on Biological Diversity. The Regulation is aimed at controlling access to results of research and technological development and the fair division of economic profits arising from the utilization of micro-organisms. Animal rights in research are protected with Regulation no. 279/2002 on Animal Experiments, which con- forms to the EU regulatory framework.
Genetically modified organisms Act no. 18/1996 on Genetically Modified Organisms deals with the protection of Iceland’s nature, ecosystem, plants and health of humans and animals from harmful and undesirable effects of genetically modified or- ganisms. It is intended to ensure that the production and use of GM organisms adheres to ethical and socially responsible rules of practice in accordance with the basic principle of sustainable development. An advisory committee shall provide advice according to the law, counsel supervisory and executive bodies on the imple- mentation of the law and promote education about genetic modification. The Environmental Agency (www. ust.is) grants licenses for specific utilization, distribution or marketing of genetically modified organisms. Specific regulations (no. 493/1997, 68/1998, 275/2002 and 276/2002) apply to individual aspects of the utiliza- tion of genetically modified organisms. In general, EC directives form the basis for Icelandic regulation in this WiCell Iceland field of research and development. www.wicell.com The WiCell laboratory in Reykjavik, Iceland, is a Embryonic Stem Cell Research branch of The WiCell Research Institute, a non- Embryonic stem cell research is not prohibited in Iceland, but therapeutic and reproductive cloning are. profit organization established in October 1999 The only provisions relevant for embryonic stem cells research are provisions in the Act on Artificial Fertiliza- to advance stem cell research in the hope that tion no. 55/1996, where research on embryos is addressed in Articles 11 and 12. diseases such as Parkinson’s, diabetes, heart dis- Article 11: All research, experiments and operations on embryos is prohibited. Nevertheless, it is permitted to ease and Alzheimer’s may be treated by replac- carry out research on embryos: a) if it is part of an in vitro fertilization treatment, b) if the intention is to diag- ing damaged cells with healthy ones. nose hereditary diseases in the embryos themselves, c) if the purpose is to advance the treatment of infertility, The Scientific Director of the Institute is Univer- or d) if the purpose is to improve understanding of the causes of congenital diseases and miscarriages. sity of Wisconsin researcher James A. Thomson, Art. 12: It is prohibited to: a) cultivate or produce embryos solely for research purposes, b) cultivate embryos V.M.D., Ph.D. Dr. Thomson directed the group for more than 14 days outside the body or once the primitive streak has appeared, c) transplant human that reported the first isolation of embryonic embryos into animals, and d) perform cloning. stem cell lines from a non-human primate in In Regulation no. 568/1997 on Artificial Fertilization it is further stipulated in Article 22 that it is prohibited to 1995, work that led his group to the first success- carry out research on embryos based on Act no. 55/1996, Article 11, as defined in c) and d): c) if the purpose ful isolation of human embryonic stem cell lines is to advance the treatment of infertility, and d) if the purpose is to improve understanding of the causes of in 1998. congenital diseases and miscarriages, unless the research fulfills the criteria of a scientific study as defined in WiCell Iceland focuses on development of new Article 1, paragraph 8 of the regulation (A scientific study means research conducted with the aim of achiev- research technology and analysis of stem cell ing further knowledge, making it possible, among other things, to improve health and cure diseases), and has gene expression, using samples from WiCell’s stem cell lines and microarrays from NimbleGen been granted approval by the National Bioethics Committee or an institutional ethics committee, according Systems of Iceland, produced by NimbleGen’s to Act no. 74/1997 on Patients Rights. patented Maskless Array Synthesizer (MAS) technology. Patenting The European Patent Convention entered into force in Iceland on November 1, 2004. Iceland thus became the 29th member state of the European Patent organization. European patent applications filed on or after November 1, 2004 include the designation of Iceland, and any PCT Request filed on or after �������������������������������������������������������� that date automatically designates Iceland as an EPC contracting state for the purpose of 80 obtaining a European patent. It is not possible, however, to designate Iceland retroactively in applications filed to EPO 70 before November 1st 2004 as applications may only be registered in countries that are 60
members of the EPC at the international filing date, so these still have to enter Iceland 50
through the national route. No European patents for Iceland can be granted on the basis of 40 international applications with a filing date prior to 1 November 2004. However, a national 30 patent can be granted, provided that Iceland has been designated in the international 20 application. The designation of Iceland at the time that an international application with a 10 filing date prior to 1 November 2004 enters the European phase 2 is legally invalid. 0 Nationals of Iceland and persons having their principal place of business or residence in 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 Iceland are now entitled to file international applications with the European Patent Office as the receiving Office. 19 International cooperation and funding
Many Icelandic researchers in academic, non-profit and corporate organizations are interested in collaborating with international researchers. Such collaborations may include the study of Icelandic biological specimens or of Icelandic residents who volunteer for research. International research involving the participation of Icelanders requires collaboration with an Icelandic specialist in the field. In addition, such research also would undergo review by the National Bioethics Committee – and by the Data Protection Authority if the research involves personal data (www.nih.gov). Össur Icelandic researchers have been very successful in obtaining funding from international sources, reflecting www.ossur.com An international manufacturer of prosthetic perhaps the respect that Icelandic research enjoys internationally. International funding comprises over 20% and orthotic devices and a leading innovator in of the funds utilized for research in Iceland. A large proportion derives from contractual research agreements the field, Ossur employs over 600 staff in nine and venture capital and can therefore fluctuate significantly. locations around the globe. The company has extensive North American, European and Nordic Icelandic researchers have focused mainly on three forums of funding: the European Union through operations, with a wide network across other framework agreements, the United States through the NSF and NIH, and the Nordic Council. The emphasis markets. on these three forums has varied. Ossur’s aim is to create prosthetics and orthotics that enable people to live the kind of life they Icelandic researchers have excelled within the EU Framework programs and growing priority has been given want to, a life without limitations. The company to possible collaboration with US researchers through the National Science Foundation (NSF) and National has developed and invested in a number of re- nowned brands, which represent the highest Institute of Health (NIH). A delegation from the NIH has visited Iceland and explored its biomedicinal research standards of quality and functionality all over sector. Already, large science projects are being funded through these channels. According to RANNIS, 115 the world. Bringing together the expertise and research projects were run in Icelandic and US/Canadian collaboration in 2001, with 41 funded through US materials technology behind these names is securing future growth and taking product de- or Canadian funds. velopment to a new level. Ossur invests a record percentage of revenues in research and develop- ment, which is reflected in the number of new products launched each year. ICT and logistics Iceland maintains highly efficient and regular air and sea links with both Europe and North America. Flight A new era in prosthetic duration is 2.5-5 hours to Europe and 5-6 hours to the United States (East Coast) and Canada. Shipping: technology – The Rheo KneeTM Europe 3-4 days, the United States 7-8 days. Icelandair offers passenger and cargo services to and from In February 2005 Ossur announced the begin- more than twenty gateways year-round on either side of the Atlantic, and several other international carriers ning of a new era in prosthetic technology, with operate a number of services for at least part of the year. Three Icelandic shipping lines operate regular cargo the official debut of its Rheo KneeTM, under the company’s equally new Bionic brand. The device schedules serving ports in North America, Scandinavia, the UK, continental Europe and the Baltic, and have has been undergoing a limited launch since the highly developed international freight forwarding systems. Furthermore, these lines operate bulk charter summer of 2004, during which time it has cap- transportation for specific imports and exports, for example industrial raw materials and finished products. tured the imagination and admiration of the media, its initial users and the prosthetists that Iceland’s harbors are ice-free all year. have fitted it. The Rheo Knee is the first microprocessor swing and stance knee system to utilize the power of artificial intelligence. The knee has the abil- ity to learn and adapt to its user’s movements, resulting in continually improved and optimized performance. State-of-the-art bionic technol- ogy instantly adapts to real-world walking conditions. Through the use of a microprocessor, integrated sensors and an innovative magne- torheologic (MR) fluid actuator, the Rheo Knee allows the user to walk as nature intended, with a constantly monitored and improved gait. The advanced sensor technology – sensing at the rate of 1000 times per second – combined with the MR actuator, capable of acting at the same rate, reads the user’s position and activity and adjusts for the optimal degree of stability while walking, standing, traversing uneven ground, descending ramps and stairs and moving within small spaces. Time Magazine selected Ossur’s high-tech Rheo Knee as one of the world’s coolest inventions of 2004. 20 The positive business environment as a resource
Europe’s most competitive economy IMD World Competitiveness Yearbook 2005 ranks Iceland #4 globally and #1 in Europe. Iceland offers a positive business environment, a sim- ple tax system with only 18% corporate income tax, a well-educated and flexible labor force and advanced technical infrastructure.
Iceland has systematically made its business environment increasingly attractive for investment and location, among other things with the series of tax cuts that now give Iceland one of the lowest levels of corporate income tax in Europe. Legislation is liberal, as the principles of business philosophy of the European Union have been implemented.
The competitiveness of Iceland
Education, technological infrastructure, societal framework and positive attitudes and values are among the factors which have ensured Iceland’s increasing competitiveness over the last few years according to the IMD World Competitiveness Yearbooks. WCY 2005 ranks Iceland Short distances between number 4 overall and number 1 in Europe. people Other international comparative studies, such as the Global Entrepreneurship Monitor published by the GEM consortium, have confirmed that Iceland is one of the world’s most entrepreneurial economies with activity similar to the US. “In Iceland, people have to deal with Iceland ranks among the top 10 “free” nations of the world, according to the 2005 Index of Economic various issues simultaneously, as a small Freedom, published by the Wall Street Journal and The Heritage Foundation. country has less specialization. This means people are exposed to a multi- Iceland is the world’s second most successful economy in exploiting developments in information and tude of problems which sometimes turn communications technology according to the World Economic Forum’s Global Information Technology Report into business opportunities. Distances 2004-2005. An earlier GITR report called Iceland “one of the world’s most technologically sophisticated between people are short and a fairly good internet connection and post societies”. system means supplies can be ordered The United Nations’ E-commerce and Development Report 2003, published by the Secretary of the United from wherever in a matter of days. The Nations Conference on Trade and Development, confirmed Iceland’s leading position in information and support program (Impra, Rannis, etc.) is interested in development of high communication technology. Internet access is generally most widespread in the Nordic Countries, with technology and flexibility wherever Iceland and Sweden tied for top place (www.unctad.org). possible”. Iceland ranks with the least corrupt countries in the world, according to Transparency International. In the 2004 Corruption Perceptions Index, which reflects the perceptions of businesspeople and country analysts, Baldur Thorgilsson, both resident and non-resident, Iceland scored 3rd-4th best out of 146 countries. head of Hardware Department, Kine Ltd.
Doing Business in Iceland
As a member of the 28-nation European Economic Area (including all EU states and three of the four EFTA states), Iceland basically implements the same liberal business policies as the European Union. Excepting a few limited areas, EU commercial legislation and directives have effect in Iceland. Consequently, Iceland offers an ideal springboard for tariff-free access to the overall EU market area, as well as a fully competitive location where EU companies can operate. No restrictions are imposed in Iceland on the purchase or sale of foreign currency. In principle, foreign ownership of business is also unrestricted. However, some limitations apply to specific sectors, i.e., fishing, primary fish-processing, energy production and aviation. A wide range of portfolio investment options is available through licensed securities trading companies.
The advantages Iceland offers to industrial investors include the most competitive electricity prices in Europe, with typical figures of 2-3 US cents/kWh, depending upon delivery terms, for major industrial users, and industrial steam at 6 barg or USD 3 per ton. Industrial sites with excellent natural harbors, for small as well as large ventures, are available in many parts of the country, and numerous local authorities have designed 21 development strategies and scenarios which provide for new investments. Highly skilled labor is available, Attractive tax including experts in a wide range of research fields. The Icelandic tax system is relatively simple and efficient. The emphasis has been on simplifying it further, environment reducing tax rates, broadening the tax base and concluding additional double-taxation treaties. Corporate income tax is 18%, among the lowest rates within the OECD. Furthermore, corporations registered in Iceland “The main reason for our continuing with the main part of their income from foreign sources can apply to keep their books of accounts and records operations in Iceland, although only in a foreign currency. Limited liability companies, registered on an official financial market, are also allowed less than 2% of our sales are there, is the quite attractive tax environment. to issue their share capital in a foreign currency. Other limited liability entities are allowed to issue their share Other reasons include a supportive capital in a foreign currency by meeting certain requirements. investment community and political environment. The inherent flexibility and responsiveness to changes are in our mind one of the key strengths of our economic system and business en- Some characteristics of Icelandic tax law: vironment. The most positive change • Corporate income tax of 18% levied by the state; no municipal corporate income tax in the business operating environment • No tax on dividends received by corporations was the reduction of corporate income • No requirements relating to the percentage of stock ownership for the corporate payer tax from 30% to 18%. Another positive example is that Icelandic companies are • Consolidated returns available for corporations which are under 90% common control now allowed to use their functional • No branch-profits tax levied on repatriated profits from branches currency as their reporting currency in • Double taxation treaties available their Financial Statements.” • Foreign tax credit available to avoid double taxation in the absence of tax treaties
Hjorleifur Palsson, • No legislation on controlled foreign corporations CFO Corporate Finance, Ossur Inc. • No legislation on thin capitalization • No basket system regarding foreign tax credit.
Taxes on businesses
• Companies resident in Iceland and Icelandic branches of foreign resident companies are liable to corporate income tax (national income tax) on their net earnings. • Companies in Iceland pay a net wealth tax, as do individuals. • Real-estate taxes are paid locally by businesses, along with local service charges.
Every company residing and operating in Iceland must submit annual accounts that comply with statutory accounting and disclosure rules, and reflect a true and fair view of the company’s assets, liabilities, outcome and financial position. The presentation is modeled on standard EU requirements. The requirement for adjustments to revalue assets and liabilities on the principles of inflationary accounting was abolished in 2001. Companies above a certain size that are publicly quoted and have subsidiaries are required to prepare consolidated group accounts. Tax returns are filed with local tax authorities.
� Corporate Income Taxes �������������������� � � ��������������������������������������������������� � �
� � ������ 48,579
� � ������� 39,343
� � ��� 37,483
� � ��� ������� 36,261
� � ������ 33,865
� � �� 29,989
� ������� 29,141
� ������ 27,417
�� ����� ��� ����� ������ ����� ������ ������� ������ ������ ������� ������� ������� 15000 20000 250000 30000 35000 40000 45000 50000 ������� ������� �������� ��������� ������� ����������� ����������� ���������� �����������
������������� ����������������������������������������� ������������������������������������������������
22 Further information
the development of health related tourism, both in Corporate websites the area of spa and wellness and in developing medical treatments for psoriasis. It also develops and markets a skin care line based on the geothermal seawater's Actavis Group www.actavis.com active ingredients. The Actavis Group aims to become a leading player in the development, manufacture and sale of high-quality generic Cyclops Inc. www.cyclodextrin.is pharmaceuticals. Founded in 1956, the Group now operates across five deCODE’s drug delivery technologies are based on continents and has its headquarters in Iceland. Principal cyclodextrins and various pharmaceutically-safe markets include Germany, Turkey, Bulgaria, Serbia, Russia additives (water soluble polymers, acids and salts) that and the Nordic Countries. Experienced teams of pharmacists, greatly enhance complexation efficiency and thereby chemists and other scientific professionals help to make up a will improve lipophilic drug solubility and consequently total workforce of around 7,000. its bioavailability.
ART Medica – IVF Iceland www.artmedica.is deCODE Genetics www.decode.com
In vitro fertilization clinic and research laboratory specializing in infertility treatments and reproductive medicine. Based on Encode - Pharmacogenomics the successful IVF unit at the Landspítali University Hospital, private clinic ART Medica strives to provide high-quality www.encode.is service and be at the forefront in science and technology. Encode Inc. is a pioneer in its field of operations as Doctors at the clinic are members of the Nordic Fertility the first CRO founded in Iceland. Encode is a leading Society, the European Society of Human Reproduction and company in pharmacogenomics, which combines Embryology and the American Society of Reproductive advanced genetic research with clinical trials, enabling Medicine identification of the genetic variations that cause people to respond differently to the same drugs.
BioCule www.biocule.com Iceland Genomics Corporation BioCule is an R&D company focused on genetic technology. The company's main purpose is to develop and market novel www.icelandgenomics.com methods to detect and isolate polymorphisms, mutations see page 7-8 and lesions in complex DNA samples such as human DNA. The original incentive was the need for powerful methods for genetic research on complex diseases in Iceland. These The Icelandic Heart Association methods, however, have worldwide applicability in various www.hjarta.is – see page 17 types of genetic research. They are therefore being marketed internationally. BioCule is a university start-up company founded in December 2000 by three entrepreneurs, in Institute for Experimental Pathology of collaboration with the University of Iceland and the National the University of Iceland - Keldur University Hospital www.keldur.hi.is
Bio-Gels Pharmaceuticals www.islandia.is/skulis The Institute at Keldur in Reykjavik operates under an Act of parliament from 1990. Its main fields of operation Bio-Gels Pharmaceuticals is a research-based are: basic research in biology and medicine of animals biopharmaceutical company focusing on mucosal drug and humans; applied veterinary research, health delivery systems and antimicrobial products containing control and diagnostic services for animal diseases lipids as active ingredients. The company was founded to in collaboration with the Veterinary Directorate continue and commercialize research by professors at the and development of methodology in these fields; University of Iceland on treatment of ulcers and cold sores development, production and distribution of veterinary and on mucoadhesive drug delivery systems vaccines and drugs; research and development to further biotechnical industries in Iceland. The Institute’s activities are quite diverse and include pathology, Blue Lagoon www.bluelagoon.com microbiology, immunology, parasitology, biochemistry and molecular biology. Blue Lagoon which communicates world of healing power, wellness and beauty, is founded on a unique source of geothermal seawater that originates in Iceland's extreme Landspítali – University Hospital environment. www.lsh.is The company has created a distinct concept of products At LUH the research emphasis is both basic and clinical, and services either based on BLUE LAGOON geothermal in addition to developmental research. The bulk of seawater's active ingredients - mineral salts, silica and algae the research is clinical. It is estimated that about 400 - or the close proximity to the seawater and its raw natural scientific projects are ongoing at the hospital. Most surroundings. of the researchers are medical doctors but other Constant developments and strategic growth characterize professions are increasingly engaged in research. The Blue Lagoon's history. The company is a market leader in research environment is favourable and the index rate 23 of papers, produced in Iceland, in scientific journals Navamedic www.navamedic.com is very high. The hospital’s employees published 167 articles in scientific journals in 2003 and 154 in 2004. Navamedic ASA, together with Norwegian pharmaceutical company Weifa, has developed a highly competitive generic osteoarthritis (OA) drug based Lindgen – Cold Spring Harbour on glucosamine HCl. OA is a widespread disease, and Laboratory traditional medication may have severe side-effects. Educated workforce and Glucosamine, as a naturally occurring substance in the www.lindgen.is powerful communication body, is not known to have any serious side-effects and See page 15 and data transer service substantially improves the quality of life of patients suffering from OA. Lyfjaþróun www.lyf.is NimbleGen Systems of Iceland, LLC www.nimblegen.com “The information industry in Reykjavik Lyfjaþróun is a biopharmaceutical R&D company See page 18 benefits from, amongst other things, specialising in nasal delivery of drugs. The portfolio an educated workforce and a power- of activities undertaken by the Company includes NorthIce Ltd. www.northice.com ful communication and data transfer drug screening, formulation development, service. A steady economy and low in- pharmacokinetics, pre-clinical experiments and NorthIce, the producer of NorthTaste All Natural come tax for businesses makes Iceland clinical trials. The Company has a particular focus Seafood Stock, was established by North Ltd., an a popular spot in Europe”. on rapid onset of action beneficial for the treatment enterprise owned by scientists and experts who of conditions such as migraine, pain and epileptic in recent years have worked at research on cold- Róbert Wessman seizures. Other activities include formulation research, active (psychrophilic) enzymes and their industrial CEO – Actavis pharmaceuticals quality assurance and control, small scale clinical trial applications. The methods of producing NorthTaste are manufacturing and nasal tolerability. Facilities include among the results of this research and development in-house animal facility, analytical laboratory facilities, that have taken place over the last 15 -20 years. North clinical trial area and GMP manufacturing suite. has applied for a patent for the utilization of cold- Lyfjaþróun exercises flexible business arrangements – active enzymes to produce NorthTaste. According to licensing/partnership/collaboration/contract services. an agreement between North and NorthIce, the latter has exclusive global rights to exploit the patent. Products/Services: Nasal delivery of drugs, peptides, proteins and other biomolecules. Promote rapid onset of action and Oculis Inc. – Ophthalmic Drug Design increase bioavailability. Risk management through & Delivery Company a unique nasal irritation model. Formulation related patent portfolio. www.ocul.is
Oculis Inc. is an R&D company focusing on novel Lýsi hf. – World leading experts in ophthalmic drugs and drug delivery to the eye, especially drugs for treatment of disorders affecting www.lysi.is marine lipids the posterior segment of the eye, such as degenerative Lysi Ltd. aims to be an internationally leading company diseases and vascular diseases. The company applies in the processing, development, sale and marketing both topical and systemic drug delivery. Contract of goods made from marine lipids, and to meet strict services include drug formulation and in vitro/in vivo requirements in quality and technical solutions. Lysi evaluations, as well as pre-clinical and clinical trials. Ltd. aims to be a reliable producer of products that improve health and quality of life. ORF Genetics www.orfgenetics.com Over the past 15 years Lysi Ltd. has held the leadership in research and product development in marine lipids. See page 12 The firm collaborates with the University of Iceland and the Icelandic Fisheries Laboratories on a continuous Primex – Marine Biotechnology basis. Based on this unique setup and close cooperation www.primex.is with leading international pharmaceutical firms and Employing modern biotechnology approaches, research organizations, Lysi Ltd. is widely regarded as Primex develops processes for manufacture of marine one of the world’s leading know-how centers in the derived biopolymers and proteins. Collaborating with field of marine oils and their utilization. universities, research institutions and companies world wide, Primex works to bring novel products efficiently to the market. R&D projects have emerged from the Molecular and cell biology company’s background in biotechnology. Typically, research laboratory at the Icelandic most projects comprise development and optimization of manufacturing methods, pilot-scale production CancerSociety www.cancer.is of prototypes, application and market testing and See page 13 scale-up to commercial manufacture. In each project, Primex endeavors to establish appropriate scientific and marketing collaborations in order to maximize scientific and commercial success.
24 Prokaria www.prokaria.com Production and development See page 10 of medical devices and Software SagaMedica www.sagamedica.com
Research, development, production and marketing of high-quality health-products from Icelandic medical Bonus Ortho System herbs. www.bonusortho.com Customized, precision orthopedic shoes – in a fraction Sýni laboratory service www.syni.is of the time. Bonus Ortho System has developed an Syni Laboratory Service is a privately owned company innovative custom fitting and manufacturing system offering consulting work and the service of a testing that offers the orthopedic industry new opportunities laboratory for food and feed producers, e.g. microbial for boosting productivity and increasing customer The Euketides project and chemical analyses. comfort and satisfaction. www.euketides.org With the patent-pending Bonus Ortho System, the This project is a shared-cost Research and Tech- orthopedic shoemaker or technician uses a plastic nology Development project funded by the WiCell Iceland www.wicell.com fitting form to determine the specifications for each European Commission under the Framework 5 See page 19 customer, eliminating the costly process of making program. The project is under the supervision of casts and bespoke lasts. Dr. Olafur S. Andresson, professor of genetics at the University of Iceland. The project group con- Zymetech – Marine enzyme sists of 8 partners from 6 countries. The project eMR Software www.emr.is products www.zymetech.com is focusing on the utilization of nature’s genetic Specializes in software for the healthcare services. resources, especially those of lichen, fungi and Zymetech is an Icelandic company that concentrates Main products are the Saga health care record system, algae, in producing biomolecules for the phar- on research in the field of enzymes and their use in Lega specialized in-patient system, Dax (Drug advice maceutical and chemical industries. More infor- the development and production of pharmaceuticals expert) and Baktus for dental offices. mation on the EUKETIDES project can be found and cosmetics. The company produces PENZIM, a at the Euketides website. product containing purified enzymes that have a deep-healing effect when applied to the body. The Globodent Iceland active ingredient in PENZIM is Penzyme, meaning www.seedforumnorway.com* penetrating enzyme, which is a super-active trypsin Globodent is developing new working processes proteinase from North Atlantic cod. in the area of dentistry and plans to sell tools and materials to support the processes to dentists. Test marketing of the first product, an innovative use of the composite filling materials in caries repair, will start in 2005. The next product is a cutting device that will allow dentists to cut cavities to a predefined shape and use matching prefabricated porcelain inlays. Globodent has three patents pending, and the possibility of a fourth is being explored. *Information under participants in Seed Forum Norway
Focal Software www.focal.is
FOCAL SOFTWARE has for over a decade worked with companies and organizations in healthcare, biotechnology andLife Science to design and implement quality management systems. FOCAL simplifies writing, approving and publishing of documents, while automatically keeping track of approvals, status and version control. FOCAL Quality Manual module fulfills ISO standards and FDA’s 21 CFR Part 11 regarding electronic records and signatures. The FOCAL suite of applications is integrated into Lotus Notes and includes modules for Quality Manuals, Nonconformities, Customer complaints, Audits, Human Resources, Process management, R&D, Equipment inventory and more.
Isgel Ltd. www.isgel.is
Production of various flexible cooling devices for use in the food industry and in healthcare. 25 ISO Tech www.isotech.is Stod www.stod.is Develops, manufactures and installs Quiet Linear Actuators in hospital beds. The Company is well equipped Stod serves orthopedic patients and offers prosthetic with state-of-the-art CNC design and manufacturing equipment service. Manufactures orthopedic shoes equipment, which ensures top quality in all phases of and specially designed shoes, and offers services and production. training.
Stodtaekni www.stodtaekni.is Kine – Biomedical engineering www.kine.is Manufactures orthopedic shoes and specially designed Positive environment for shoes and supplies different types of prosthetics such as Kine's mission is to provide effective solutions for wheelchairs and walking sticks. high-tech companies objective Motion Analysis in clinical settings and in research. Kline develops easy-to-use solutions based on cutting-edge concepts and technology. Its objective is Theriak - Digital healthcare www. theriak.is to support improvement of diagnostic and therapeutic “Icelandic businesses and the TM Software, Inc. is a software company with assessments for better analysis of movement in a general public are open to technical headquarters in Iceland. TM Software currently employs very broad range of applications/specializations. The innovations and ready to tackle close to 400 people in 11 countries and supports close company aims to provide innovative products enhancing demanding projects. This creates a to 1000 clients in 20 countries. Healthcare solutions from the facility and performance of objective measurements positive environment for high-tech TM Software are sold and marketed under the name in diagnostics and assessment of therapeutic progress. companies. Icelanders are accustomed Theriak. Theriak provides a solution for every point of Kine's guiding principle has consistently been to create to doing their jobs directly and the medication process to enhance safety and efficiency intelligent solutions that are both simple and intuitive. very swiftly. Lines of command are in all aspects of medication management within KineView for 2D Gait Analysis and KinePRO wireless EMG generally very short so much can be hospitals. The physician can now enter medication orders convert complex diagnostic methods into quick, easy and accomplished in a short time”. electronically while at the same time accessing relevant effective procedures. patient information online. Egill Masson, Medcare Managing Director, Taugagreining hf., www.medcare.com VIASYS Healthcare Iceland now part of Viasys Healthcare Inc. Medcare is a global leader in the development, manufacture and sale of sleep diagnostic systems. www.viasyshealthcare.com Doctors, research facilities and hospitals use these VIASYS Healthcare Inc. is a global market leader in health- systems to diagnose sleep disorders. Medcare is the only care technology – a distinction that is built on a solid company in the medical device industry that is entirely history of innovation, superior product performance, and focused on sleep diagnostics. No other company invests a commitment to customer service. VIASYS Healthcare as much of its resources in research and development and comprises many well-established companies that are building strong relationships with the top clinicians and each recognized for market leadership. These companies researchers pioneering sleep knowledge. Over 30 highly specialize in developing, manufacturing, marketing and skilled employees work in research and development servicing high-technology medical devices that are used groups in Reykjavik and Amsterdam using leading- in respiratory care, neurology, vascular medicine, critical edge development tools to create total solutions for care, and the medical and surgical product markets. the sleep diagnostic market. This dynamic group brings VIASYS Healthcare Iceland is result of Viasys Healthcare’s technological innovations to the market and the results acquisition of substantially all the assets of Taugagreining can be seen in easy-to-use, reliable and accurate system hf., an Icelandic neurodiagnostic company. Taugagreining solutions that save time and money for users. specializes in electroencephalography (EEG) technology for the diagnosis and monitoring of neurological function. Lori Cross, Group President of VIASYS Össur NeuroCare, commented: “Taugagreining brings VIASYS several technologies and applications that expand our www.ossur.com portfolio in neurodiagnostics as well as a new product See page 20 entrant in the growing market for neuromonitoring. Key competencies of Taugagreining include robust and ReMo www.remo.is innovative software development with an emphasis on simple user interfaces and multilingual capabilities.” Development and production of a respiratory movement measuring instrument. ReMo is a start-up company originating in the academic environment of the University of Iceland and Landspítali – University Hospital. The core idea is a method for measuring respiratory movements which is comfortable and painless for the patient. ReMo already has a fully functional Respiratory Movement Measuring Instrument backed with clinical research and the software to go with it. For the next phase ReMo will be looking for investors and companies for cooperation on design and marketing of the instrument.
26 Other sources of information
Life Science in Iceland www.icelandbio.com
Icelandic Center for Research www.rannis.is
Technological Institute of Iceland www.icetec.is
Invest in Iceland Agency www.invest.is
Trade Council of Iceland www.icetrade.is
National Bioethics Committee www.visindasidanefnd.is
Ministry of Health and Social Security www.ministryofhealth.is
Other Government Offices in Iceland www.government.is
Icelandic Directorate of Health www.landlaeknir.is
Icelandic Patent Office www.els.is
Data Protection Agency www.personuvernd.is
Health Technology Forum www.htv.is
University of Iceland www.hi.is
Reykjavik University www.ru.is
Federation of Icelandic Industries www.si.is
Statistics Iceland www.statice.is
Central Bank of Iceland www.sedlabanki.is
Official Gateway to Iceland – A website of the Ministry of Foreign Affairs www.iceland.is
National Institutes of Health, USA www.nih.gov
Eurostat epp.eurostat.cec.eu.int/
Organization for Economic Cooperation and Development www.oecd.org