1The heart of life sciencesfor research and business
2Table of contentsExecutive Summary..........................................................................................
35.1.5: Aalborg University (AAU) – Faculty of Medicine ................................................................. 3...
4Executive SummaryStart with Denmark, the heart of life sciences for research and businessFor a great many years Denmark h...
5The chapters provide information on the following areas:- A world-leading healthcare industry; facts and figures on the p...
6Chapter 1: 10 Good Reasons for Choosing Denmark for R&D and business activitiesThis chapter presents the ‘Top 10 Reasons’...
77. World-class patient registries, civil registries and biobanksIn Denmark, all citizens are identifiable by a unique per...
81.2: 10 good reasons for choosing Denmark for your medical devices business1. Strong, large and well-established medical ...
98. Cooperative and modern health serviceThe Danish public health service gives high priority to partnerships with busines...
101.3: 10 good reasons for investing in Denmark and the Danish eHealth industryInvest in Danish E-health; the settings are...
118. Companies willing to partner upGiven the relatively small size of the majority of the Danish E-health companies, inte...
12Chapter 2: A world-leading healthcare industryIn this chapter, you can read more the healthcare industry in Denmark. The...
13The quality of Danish pharmaceutical research is alsoat the top internationally. The number of scientificarticles per 1,...
14Measured per capita, Denmark is the country in the world that conducts the most clinical trials.Source: Measured by www....
152.2: The biotech industryAs stated in the previous section, the long-standing tradition and solid foundation for pharmac...
16More than 40,000 people are employed in the life sciences sector in Medicon Valley and there is a strongtradition and cu...
17The medical devices industry is characterised by a high concentration of small and medium-sized enterprises,and two-thir...
18Chapter 3: A strong healthcare systemIn this chapter you can read about the framework conditions of the Danish healthcar...
19The new hospitals will be established in such a way that they are flexible, meet future demand for treatment,innovation ...
20 Prevalence of the so-called Medcom standards that have digitised much of the communicationwithin the health service. P...
21compliance monitoring. By linking the different registers, unique knowledge may be acquired on delivery ofmedical care a...
223.3.6: BiobanksDenmark has been a pioneer in establishing population-based biobanks. Several large biobank cohortsprovid...
23Collaboration examples from the regionsThere is close collaboration between hospitals and universities on research, trai...
24Chapter 4: A strong tradition and sound framework conditions for clinical trialsIn this chapter you can read about the s...
25performance of complex studies requiring extensive coordination and access to high-technology equipmentsuch as scanners....
26clinical phase III trials6. The Danes are generally satisfied with the outcome of their participation in clinicaltrials ...
27What is single-point-of-entry for clinical trials?Single-point-of-entry (SPOE) is a joint procedure for Danish health re...
28Applications to the Danish Health and Medicines Authority may be submitted electronically. The trials areregistered in E...
29Chapter 5: World-class researchIn the healthcare area there is access to a strong research environment in Denmark. E.g. ...
305.1.4: Aarhus University (AU) - Faculty of Health SciencesThe Faculty of Health Sciences (Health) at AU consists of five...
31collaborate closely with Danish pharmaceutical companies such as Lundbeck A/S and Neurosearch on basicpreclinical resear...
325.3.2: The Danish National BiobankDenmark is at the very frontier of epidemiological research. This is to a large extent...
33Chapter 6: Denmark a great place to do businessIn this chapter, you can read more about doing business in Denmark. With ...
34thereby guaranteed a high level of social security, which results in a relatively high degree of labour marketflexibilit...
356.1.6: Denmark is a safe place to liveA characteristic feature of the Danish working and family life is quality – Denmar...
366.2: Human resources within the pharmaceutical industryDenmark has a large pool of human resources with high-level exper...
37Chapter 7: Financing sourcesDenmark has a range of financing sources, ranging from state incentive programmes and privat...
38The DanishCouncil forIndependentResearch:NaturalSciencesFunding for projects geared towards basicscientific issues withi...
The heart of life sciences full report
The heart of life sciences full report
The heart of life sciences full report
The heart of life sciences full report
The heart of life sciences full report
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The heart of life sciences full report

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This report invites you to read more about why Denmark is a unique laboratory for healthcare and welfare
technology, and why Denmark is an excellent place to do business.

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The heart of life sciences full report

  1. 1. 1The heart of life sciencesfor research and business
  2. 2. 2Table of contentsExecutive Summary............................................................................................................... 4Chapter 1: 10 Good Reasons for Choosing Denmark for R&D and business activities........................................ 61.1: 10 good reasons for choosing Denmark as the location for pharmaceutical research activities ..................... 61.2: 10 good reasons for choosing Denmark for your medical devices business........................................... 81.3: 10 good reasons for investing in Denmark and the Danish eHealth industry ....................................... 10Chapter 2: A world-leading healthcare industry .............................................................................. 122.1: The pharmaceutical industry ........................................................................................... 122.2: The biotech industry .................................................................................................... 152.3: The medical devices industry........................................................................................... 162.4: The eHealth industry.................................................................................................... 17Chapter 3: A strong healthcare system........................................................................................ 183.1: New hospitals and robust hospital services structure ................................................................ 183.2: Extensive digitisation – electronic communication between health service partners .............................. 193.2.1: Electronic health records at Danish hospitals .................................................................... 203.2.2: Telehealth .......................................................................................................... 203.3.3: Easy to trace patients .............................................................................................. 203.3.4: National registries.................................................................................................. 213.3.5: The Danish clinical quality databases ............................................................................. 213.3.6: Biobanks ............................................................................................................ 223.3.7: Culture of openness and collaboration between universities, healthcare professionals and industry ....... 22Chapter 4: A strong tradition and sound framework conditions for clinical trials .......................................... 244.1: Clinical trials ............................................................................................................. 244.1.1: Danish patients are keen to participate in clinical research ..................................................... 254.1.2. Single-point-of-entry for clinical trials in Denmark............................................................... 264.1.3. Quick processing of drug trial applications ....................................................................... 274.1.4: Committees on health research ethics ........................................................................... 28Chapter 5: World-class research............................................................................................... 295.1: Health research at the Danish Universities............................................................................ 295.1.1: University of Copenhagen (KU) – Faculty of Health and Medical Sciences ..................................... 295.1.2: Technical University of Denmark (DTU)........................................................................... 295.1.3: University of Southern Denmark (SDU) - Faculty of Health Sciences ........................................... 295.1.4: Aarhus University (AU) - Faculty of Health Sciences ............................................................. 30
  3. 3. 35.1.5: Aalborg University (AAU) – Faculty of Medicine ................................................................. 305.2: Positions of strength in Danish research .............................................................................. 305.2.1: Lifestyle............................................................................................................. 305.2.2: Diabetes mellitus................................................................................................... 305.2.3: Neuropsychiatry.................................................................................................... 305.2.4: Cancer research .................................................................................................... 315.3: Recent major investments in the research infrastructure............................................................ 315.3.1: DanStem ............................................................................................................ 315.3.2: The Danish National Biobank...................................................................................... 325.3.3: Other investments in research infrastructure.................................................................... 32Chapter 6: Denmark a great place to do business ............................................................................ 336.1.1: Europe’s most flexible labour market............................................................................. 336.1.2: Highly skilled, well-educated population ......................................................................... 346.1.3: Business culture & work habits ................................................................................... 346.1.4: Easy to establish a business ....................................................................................... 346.1.5: Effective infrastructure ............................................................................................ 346.1.6: Denmark is a safe place to live .................................................................................... 356.1.7: Low level of corruption ............................................................................................ 356.1.8: Easy access to researchers ........................................................................................ 356.2: Human resources within the pharmaceutical industry ............................................................... 36Chapter 7: Financing sources .................................................................................................. 377.1: Denmark and free trade ................................................................................................ 377.2: Funding opportunities in Denmark within the healthcare sector .................................................... 377.3: Aid schemes for seed capital and research financing................................................................. 41The Authors ..................................................................................................................... 42
  4. 4. 4Executive SummaryStart with Denmark, the heart of life sciences for research and businessFor a great many years Denmark has constituted an international health laboratory, attracting internationalbusinesses and researchers. Some of the main reasons are stated below: The presence of several different types of healthcare industries makes Denmark a promising locationfor investing in healthcare research The Danish healthcare industry is strongly placed: its pharmaceutical industry has the third-largestpipeline in Europe, and the Danish healthcare industry as a whole is booming Danish clinical research is a world leader: according to currently available ratings, Danish publicationsand citations rank in the top-three in the most commonly used listings The Danish population is homogeneous and clinical courses are well described. Owing to the Danishpersonal identity number system and the comprehensive national health registries and qualitydatabases, it is possible to monitor patient disease history over time. This offers unique conditionsfor clinical research Denmark is poised for a comprehensive modernisation of its national health service which willinvolve the renewal of just under one third of the existing hospital square meterage The Danish population is well educated and proficient in other languages Danish society is well-ordered: there is low corruption and the public sector is highly effective With a corporate tax rate of 25 per cent, competitive business costs and some of the world’s mostflexible labour market conditions, Denmark is an attractive choice for foreign investors. Add to this avery simple procedure for establishing a business and the presence of a highly skilled and motivatedworkforce. The result: some of the best possible conditions for doing businessFurthermore, in Denmark there is a long-standing tradition for efficient public-private partnerships in areassuch as development and testing of healthcare and welfare solutions. This applies both to thepharmaceutical industry and in medical technology, where the hearing aid segment may be held up as ashining example that has resulted in some 40 per cent of the world’s hearing aids being developed andmanufactured in Denmark.There is keen political focus on creating framework conditions conducive to research and businessdevelopment in healthcare and welfare. Investment in research and innovation is a key criterion for securingnational revenue in the future. The Danish Government will be increasing public-sector investment inresearch on an ongoing basis to ensure that at least 1 per cent of GDP is spent on state-funded research.Combined with private research investments, which account for just over 2 per cent of GDP, Denmark fullyachieved the Barcelona objective of investing 3 per cent of GDP in R&D by 2010. This is a growth driver.This report invites you to read more about why Denmark is a unique laboratory for healthcare and welfaretechnology, and why Denmark is an excellent place to do business.The report presents the reader with an introduction to the Danish healthcare industry, covering thepharmaceutical industry, the biotechnological industry, the medical technology industry and the eHealthindustry. Starting with a presentation of ‘Top 10 Reasons’ for choosing Denmark for research and businessactivities, the report is then divided into chapters focusing on the different aspects of the healthcareindustry.
  5. 5. 5The chapters provide information on the following areas:- A world-leading healthcare industry; facts and figures on the pharmaceutical industry, thebiotechnological industry, the medical technology industry and the eHealth industry in Denmark- A strong healthcare system; information on the framework conditions of the Danish healthcaresystem- A strong tradition and good framework conditions for research; information on conducting clinicaltrials in Denmark- World class research; information on Danish research areas and strongholds in the field of healthcare- Denmark as a great place to do business; information on the framework conditions for doingbusiness in DenmarkTo learn more about investing in Denmark, please contact the Life Sciences team at Invest in Denmark:http://www.investindk.com/
  6. 6. 6Chapter 1: 10 Good Reasons for Choosing Denmark for R&D and business activitiesThis chapter presents the ‘Top 10 Reasons’ for choosing Denmark for research and business activities. Thechapter presents the pharmaceutical industry, the medical technology industry and the eHealth industry.1.1: 10 good reasons for choosing Denmark as the location for pharmaceutical research activities1. Unique framework conditions for the pharmaceutical industryDenmark is a modern knowledge-based society with excellent framework conditions for theresearch-based pharmaceutical industry – including a flexible labour market, favourable taxationrules for research-based businesses, a well-educated population, a low level of corruption, a highlevel of security and stable macroeconomic conditions. Pharmaceutical products constituteDenmark’s largest export commodity. Denmark has excellent framework conditions in the shape oflow corporate tax (25%), tax breaks on research partnership expenses, and international researchersbenefit from a special low tax rate (26%). Since 2009, Denmark has fulfilled the Barcelona objectiveof investing at least 3 per cent of GDP in R&D. Private investment currently accounts for just under 2per cent, and public-sector investment approx. 1 per cent. The Danish Government’s goal is for atleast 1 per cent of GDP to be spent on public-sector research investment.2. Denmark ranks 2ndinternationally by the number of publications based on clinical trials andpharmaceutical researchDenmark offers access to high-capability research centres devoted to the field of pharmaceuticals.The medical foundation at both universities and hospitals is very solid, as demonstrated by the highoutput of frequently cited scientific articles in leading international journals.3. Tradition for close public-private partnershipsDanish universities and hospitals are open and accustomed to collaborating with private-sectorbusinesses.4. State investments in public-private research partnershipsDenmark offers excellent opportunities for public-sector funding for establishing public-privateresearch partnerships such as via the The Danish National Advanced Technology Foundation, theDanish Council for Strategic Research and the Industrial PhD Programme.5. Highly qualified labourIn Denmark it is easy to recruit staff with the right medical expertise at the highest internationallevel. Denmark has a large and rising number of masters’-equivalent and PhD degree holders fromthe universities. In addition, Danish pharmaceutical and biotech companies constitute aninternational powerhouse conducive to recruitment of international employees.6. Heavy investment in new research infrastructure creates unique frameworks for pharmaceuticalresearch in DenmarkDenmark is currently making a large number of research infrastructure investments. Examplesinclude: 1) European Spallation Source, 2) a proposed National Centre for Particle Therapy, 3)International Science City at North Campus, 4) Center for Protein Research, The Danish Stem CellCenter and The Novo Nordisk Foundation Center for Basic Metabolic Research, all at the Universityof Copenhagen; 4) New hospital buildings worth more than DKK 40bn which will renew just under athird of the Danish hospital square meterage by 2020: 5) the establishment of the multidisciplinaryDanish Platform for Large-scale Sequencing and Bioinformatics.
  7. 7. 77. World-class patient registries, civil registries and biobanksIn Denmark, all citizens are identifiable by a unique personal ID number system. In addition, there isaccess to comprehensive biobanks and to large registries containing detailed patient data, whichoffer unique opportunities for epidemiological research and support for both basic scientific researchin pharmaceuticals and clinical pharmaceutical research.8. The best clinical trial subjectsDanish patients (and healthy clinical trial subjects) are compliant, readily identified and monitored,have a high level of educational attainment and are positive about participating in clinical research.9. Health service of high international standardIn Denmark there is access to a well-organised, public-sector financed health service of a high clinicalstandard, with qualified, reliable and experienced doctors and nurses in clinical researchenvironments of a high international standard.10. Efficient public authoritiesEfficient administrative procedures performed by competent public-sector authorities ensure rapidapproval of clinical pharmaceutical trials by the Danish Health and Medicines Authority and thenational and regional system of committees on health research ethics.GlaxoSmithKlineOn Invest in Denmark’s homepage Mike Connell, former V.P. and General Manager of GlaxoSmithKlineDenmark, explains why one of the worlds leading research-based pharmaceutical companies has chosento invest in Denmark: http://www.investindk.com/News-and-events/News/2012/Watch-GSK-explain-why-they-have-invested-in-DenmarkMSD Denmark“In Denmark, we have great success in recruiting participants for megatrials in cardiology, osteoporosisand vaccines. We have positive examples of over-recruitment, and compared with other countries we havethe most impressive retention rate in clinical trials. In Denmark, no patient is ever lost to follow-up – whichis a major problem in many other countries. All of this means measurable results, and is the reason why wehave succeeded in attracting so many studies in the MSD pipeline. This is why, for a good many years now,we have been investing hundreds of millions of kroner in research and development in Denmark. But in ahighly competitive market one of the preconditions for retaining investment in clinical research is awillingness to adopt new, innovative therapies when they come out on the market, otherwise there is noinvestment incentive.” (Iben Ordrup Christensen, Clinical Research Director, MSD Denmark & Iceland)SANOFI Denmark“At SANOFI Denmark we are often the first country in Europe to include a patient. Our agile response is dueto our investigators who are swift to make a decision on trial viability and because we have the DanishHealth and Medicines Authority and a system of committees on health research ethics that make rapid andprofessional trial assessments. In recent years, we have also managed to include more patients thanoriginally planned. When our headquarters select countries for conducting trials in, predictability is a keyfactor. Based on the above, we know that this is where Denmark holds its own.” (Malene Kelstrup, MedicalDirector, Sanofi-Aventis Denmark)
  8. 8. 81.2: 10 good reasons for choosing Denmark for your medical devices business1. Strong, large and well-established medical devices industryThe Danish medical devices industry is well-reputed abroad for a number of leading global companies inconsumables, hearing aids, diabetes devices and diagnostic devices. These companies are prominent inDanish business and industry and spearhead a strongly positioned Danish medical devices industry,which measured in exports per capita is one of the largest in the world.2. Boom in medical devices SMEsThe core of the Danish medical devices industry is made up of a large number of small and medium-sizedenterprises comprising innovative manufacturers, distributors and international sales companies,subsidiaries and consultancies. The many players in the industry make for a dynamic environment ofclusters and networking opportunities.3. Well-developed innovation environmentThe medical devices industry is sustained by innovation and product R&D, and Danish enterprises benefitfrom an array of well-established innovation centres distributed throughout Denmark.4. Strong medical devices industry clusters with research centres and well-qualified staffAcross Denmark, regional authorities, universities and science parks are investing heavily in thedevelopment of medical devices industry clusters and innovative research environments in an interactionbetween businesses, universities and hospitals – these clusters foster the development of newtechnologies and the emergence of new businesses.5. Productive tradition and culture for collaboration between industry, healthcare personnel andresearchersDenmark has a wholly unique tradition and culture for collaboration, open-door policy and a spirit ofinquiry in fostering new partnerships between industry, healthcare personnel and researchers.6. Unique capability in developing and incorporating design in product developmentThe strong Danish design tradition extends to R&D in medical devices and is a unique competitiveparameter in this sector. User-friendly and intuitive design is an increasingly crucial element in medicaldevices R&D, and in this field Denmark has a unique position of strength.7. Large-scale redevelopment of Danish hospitals up to 2020The Danish hospital sector is poised for a comprehensive programme of newbuilds and extensions to thenation’s hospitals, with just under 30 per cent of the total hospital square meterage due for renewal by2020. Substantial funds have been earmarked for new technologies, equipment and infrastructure inextension of the building works.
  9. 9. 98. Cooperative and modern health serviceThe Danish public health service gives high priority to partnerships with business and industry. In thelight of the hospital construction works, immediate opportunities exist for increased cooperation ondeveloping new technologies and solutions for future efficiency-improvements in the hospitals sector.This applies both to core functions and non-patient-centric functions.9. A well-qualified workforceDenmark has a very well-qualified workforce within the life sciences area as a whole, with recruitmentopportunities from the universities as well as specialists and experts from the nation’s large life sciencessector.10. Efficient and service-oriented authoritiesThe Danish authorities, among which the Danish Health and Medicines Authority is a key partner for newmedical devices businesses, are known for their rapid, efficient and service-oriented administrativeprocedures, extensive digitisation and self-service, which help to ensure the best possible framework forestablishing and running a business in the country.Attention“One significant area is our ability in productive innovation environments to jointly come up with highlypatentable solutions that give the companies value for money in the long term.” (Henrik Jeppesen,Managing Director, Attention)Pallas Informatik“The most unique skills are often embedded in the culture and also the most difficult for other countries tomatch.” (Jens Peter Andersen, Quality Manager and Project Manager, Pallas Informatik)
  10. 10. 101.3: 10 good reasons for investing in Denmark and the Danish eHealth industryInvest in Danish E-health; the settings are second to none1. Test on a small scale among the bestUse Denmark as a testing ground; the business risks are manageable in a country with only 5.5 millioncitizens. Denmark is representative of the leading markets in the world, with fierce competition between thebest E-Health companies. Solutions selling well in Denmark can be expected to do well everywhere.2. Public-sector fundingPublic-sector funding is available for E-health solutions that test new grounds for delivering health servicesfaster and cheaper. The Danish Government is investing EUR 5.6bn (EUR 1,000 per capita) in an ambitiousplan to establish new, digitised hospitals. The funding is earmarked for public-private partnerships.3. The infrastructure of tomorrowWith almost universal penetration of broadband, the Danish digital infrastructure is among the best in theworld. Denmark offers a unique opportunity for testing demanding solutions in a national setting with theinfrastructure of tomorrow.4. Empowered patients and e-ready staffDanish citizens are among the most e-ready in the world. In all public- and private-sector domains digitisationhas been widely adopted, including within E-health-services at hospitals, at GP surgeries, in municipalitiesand in people’s own homes. Highly skilled staff across the health sector make testing of innovative solutionspossible.5. Patients firstDanish solutions are tested for their ability to put the patient first. Denmark has a long-standing tradition fordesigning solutions that span sectoral barriers, creating coherence in the treatments and putting the patientfirst.6. Standards-driven integration means ready for exportDenmark is committed to adhering to international standards for data-processing and sharing. This makes iteasier to both import and export solutions worldwide. In Denmark we test and deploy in settings withchallenging demands for integration. Solutions capable of delivering results in Denmark are knownworldwide for their ability to integrate with solutions in use abroad.7. National references readily attainableRegarding eHealth solutions, the public sector is aware of the value of strong national reference cases. Incombination with a coordinated public effort for nationwide usage of solutions demonstrating positiveoutcomes, national references are readily attainable for companies.
  11. 11. 118. Companies willing to partner upGiven the relatively small size of the majority of the Danish E-health companies, international partners readyto invest in partnerships stand to benefit from shortcuts to Danish solutions and markets.9. “Danish inside” means assured data protectionDenmark has a long tradition for secure handling of large data volumes. Companies can use the Danishskilled developers as a springboard for readying their solutions to meet the stringent internationalrequirements for personal data protection. If it’s secured in Denmark, it’s done right.10) Safe haven for investmentsPlace your investments in Denmark; it is a safe haven in a time of international financial crisis.Strategic Intelligence Monitor on Personal Health SystemsSIMPHS research has identified Denmark, together with England and Scotland, as “leaders in terms ofmainstream telehealth in Europe in a combination of demand-side factors, high eHealth deployment, goodgovernance models and in terms of the commitment of key stakeholders in the different tiers of the careand value chain.”Source: Strategic Intelligence Monitor on Personal Health Systems (SIMPHS). European Commission, JointResearch Centre, Institute for Prospective Technological Studies, March 2012
  12. 12. 12Chapter 2: A world-leading healthcare industryIn this chapter, you can read more the healthcare industry in Denmark. The chapter covers thepharmaceutical industry, the biotechnological industry, the medical technology industry and the eHealthindustry.2.1: The pharmaceutical industryResearch, development and manufacture of pharmaceutical products represent one of Denmark’scommercial strengths. Danish pharmaceutical companies rank among the absolute world elite in therapeuticareas, such as diabetes, depression, skin disorders and allergies, while subsidiaries of all the majorinternational pharmaceutical firms are also present in Denmark where many of them have substantial clinicalresearch activities.This means that from a global perspective, Denmark is at the very forefront in pharmaceuticals R&D andpharmaceutical exports. In 2010, Danish firms had more than 120 pharmaceutical candidates in the clinicalpipeline (in either phase I, II or III), which in absolute figures and in a European context is surpassed only bythe UK and Germany (source: Ernst & Young, German Biotechnology Report 2011, April 2011). Measured percapita, Denmark has, without a doubt, the biggest pipeline in Europe.Danish pharmaceutical exports have been increasingly sharply over many years. In 2010, exports topped theDKK 50bn mark. In 2011 the increase continued, with exports currently at just over DKK 57bn.The sharp growth in pharmaceutical exports means that pharmaceuticals are currently the commodities thataccount for the lion’s share of Danish exports.Pharmaceuticals represent Denmark’s largest export area – approx. 10 per cent of total Danish exports(source: Statistics Denmark, 2010).
  13. 13. 13The quality of Danish pharmaceutical research is alsoat the top internationally. The number of scientificarticles per 1,000 capita is the second-highest in theworld, and the impact of those publications issurpassed only by Switzerland (see figures below).Measured per capita, Denmark can lay claim to beingthe country in the world with the second-largestvolume of publications based on pharmaceuticalresearch. Citation analyses reveal that the impact ofDanish publications based on pharmaceuticalresearch is significantly above the OECD average,surpassed only by Switzerland. Danish publicationsare among the most frequently cited in the world.Source: Report on bibliometric mapping of Danish pharmaceutical research 2003-2008
  14. 14. 14Measured per capita, Denmark is the country in the world that conducts the most clinical trials.Source: Measured by www.clinicaltrials.gov, 20 May 2010. In Kortlægning af dansk lægemiddelforskning -Delnotat III kliniske forsøg (Mapping of Danish pharmaceutical research, sub-report III, clinical trials), DanishAgency for Science, Technology and Innovation, October 2010.The Danish pharmaceutical companies are involved in a range of research activities in close collaborationwith Danish universities and the public health service. Private-sector pharmaceutical research as a wholeaccounts for 23 per cent of all private-sector research in Denmark – in absolute figures; the pharmaceuticalindustry in Denmark invests more than DKK 8bn per annum in research.This means that within the international context, private-sector pharmaceutical research in Denmark isdistinctive in that it accounts for a very large share of total business and industry R&D investments. Lookingat clinical research in isolation, pharmaceutical companies in Denmark with research activities invest approx.DKK 1.5bn per annum. Of this, a large share – estimated at just under DKK 300m – covers external clinicalresearch activities at Danish hospitals.The long-standing tradition and solid foundation for pharmaceutical research in Denmark have alsofacilitated the establishment of a number of biotech companies, for example, in the Danish-Swedish MediconValley cross-border cluster, which in turn has helped to place Denmark firmly on the world map.
  15. 15. 152.2: The biotech industryAs stated in the previous section, the long-standing tradition and solid foundation for pharmaceuticalresearch in Denmark have facilitated the establishment of a number of biotech companies. More than 150years ago, Danish agriculture sowed the seeds for a national research industry and since then, researchmethods have been evolving continually in Denmark.Medicon Valley, one of Europe’s top three sites for biotech innovation alongside Cambridge in the UnitedKingdom and Basel in Switzerland, spearheads the Danish biotech cluster with a strong presence and closecollaboration between universities, hospitals and companies. The Medicon Valley hub is the area spanningEastern Denmark and South-Western Sweden and is connected via the Øresund bridge. As one ofEuropes strongest life science clusters, Medicon Valley is home to a large number of life sciencecompanies and research institutions located within a very small geographical area.Medicon Valley represents the entire (bio) pharmaceutical value chain from target identification throughpreclinical and clinical development to manufacturing. The presence of large pharmaceutical companies inthe cluster has a positive effect on SMEs when it comes to research initiatives and research talents. The mainfocus areas of Medicon Valley include therapeutic areas such as diabetes/metabolism, neuroscience, cancer,inflammation and allergy. Furthermore, Medicon Valley is at the forefront of personalised medicinedevelopment.Including the Southern part of Sweden, Medicon Valley is a hub for: More than 100 biotech companies with R&D and/or production 25 pharma companies (7 major) 100 medtech companies Approx. 80 Contract Research Organisations and Contract Manufacturing Organisations 32 hospitals, 11 of which are university hospitals 12 universities, 5 of which offer life science related degree programmes 7 science parks with a significant focus on life science 6 incubators of which 3 focus exclusively on life scienceFacts about the Danish pharmaceutical industry: Number of companies: 170 marketing authorisation holders. The 20 largest accountsfor two-thirds of the market. Number of employees: Approx. 20,000 employees (creates a total of approx. 70,000jobs, including employees in sub-industries). In the period 1999-2008, the number ofemployees increased by more than 30%. Measured by the number of employeesrelative to the size of the Danish population, Denmark has the second-largestpharmaceutical industry in the world. Exports: Worth just over DKK 57bn in 2011. Pharmaceutical exports currentlyrepresent Denmark’s largest export sector, approx. 10% of total Danish exports. Since1997, pharmaceutical exports have more than tripled. Approx. 90% of Danishpharmaceutical production is exported. Sales 2010: DKK 100bn in Denmark. [Based on the Danish flagship companies’ totalsales + subsidiary-based companies’ sales in Denmark.]
  16. 16. 16More than 40,000 people are employed in the life sciences sector in Medicon Valley and there is a strongtradition and culture for networking and collaborating in the region. This also facilitates informal networkingand meetings between the cluster’s stakeholders.2.3: The medical devices industryThe medical devices industry is made up of companies that develop, manufacture and sell instruments,apparatuses, implants, and reagents for the diagnosis, treatment and prevention of disease. The industry isinnovation-led and characterised by a short route from concept to finished product and a rapid productlifecycle. Measured per capita, Denmark has one of the largest medical devices industries in Europe in termsof exports and number of employees and as an industry has a long and proud Danish industrial heritage.The Danish medical devices industry is known for its large global manufacturers of disposable devices, andapparatus and hearing aid manufacturers. In addition, the industry consists of a large number of small andmedium-sized manufacturers, including several innovation companies as well as distributors and sub-distributors. At the same time, all the major international medical devices companies maintain a presence inDenmark via sales companies and subsidiaries.The Danish medical devices industry upholds a long-standing tradition for close and systematic collaborationwith health professional environments at hospitals and with university research environments, and is at theleading edge of the latest developments in medical technologies, including telehealth, robot technology,point-of-care and sensor technologies. The medical devices industry also links in with the diagnostics, rehaband assistive devices industries, and there is widespread overlap between multiple companies andcollaboration across the different industries.Source: Medicoindustrien
  17. 17. 17The medical devices industry is characterised by a high concentration of small and medium-sized enterprises,and two-thirds of companies in the industry have fewer than 50 employees. More than 95 per cent of Danishmedical devices are exported, and there is a substantial export surplus. A large share of Danish medicaldevices imports are incorporated into domestic production and subsequently re-exported as finishedproducts.The Danish Health and Medicines Authority under the Danish Ministry of Health is the national regulatorybody for medical devices. The Authority’s principal function in this domain is to implement regulatorysystems for the safety and performance of medical devices on the market. Information about rules andguidances on medical devices is available at http://medicaldevices.dk/2.4: The eHealth industryThe Danish eHealth companies are growing, showing profits and are regarded internationally as holding hugepotential for both further national growth and international exports. Out of the 92,000 employed in Danishprivate-sector ICT-companies, approximately 2,000 work for companies devoted mainly to eHealth, withannual turnover of an estimated EUR 0.5bn. A majority of these companies are organised under the DanishIT-Industry Association (www.itb.dk).Facts about the Danish medical devices industry: Market growth: Stable growth of around 5-6 per cent p.a. Growth in exports: Doubled in the period 1999-2009 Growth in imports: Almost tripled in the period 1999-2009 Sales: Approx. DKK 50bn in 2010 (medical devices companies in Denmark and Danishcompanies abroad) Number of companies: 250 dedicated medical devices companies (total of 1,000 companiesin the industry) Number of employees: 20,000+ in Denmark (measured per capita, this gives Denmark oneof the largest medical devices industries in the world)
  18. 18. 18Chapter 3: A strong healthcare systemIn this chapter you can read about the framework conditions of the Danish healthcare system. Thehealthcare industry in Denmark is supported effectively by: Five regions with responsibility for the public health service New hospitals within a robust hospitals structure Extensive digitisationThe health service in Denmark is operated largely by the country’s five regions, which have primaryresponsibility for the healthcare sector, including clinical psychiatry, doctors in private practice andspecialists etc. In addition, the regions, jointly with the four faculties of health sciences, have executiveresponsibility for optimising the frameworks and conditions that govern national healthcare research.The 98 municipalities under the five regions provide a number of health services, such as out-patientrehabilitation and preventive and health-promoting initiatives.3.1: New hospitals and robust hospital services structureOver the next decade, the five regions of Denmark will be implementing significant changes to the Danishhospital service. More than DKK 40bn is being invested in new hospitals and extensions to existing hospitalsover the period 2010-2020. This corresponds to the renewal of just under one third of hospital squaremeterage in Denmark.The hospital investments will modernise and future-proof the hospital service not least by consolidatingemergency and specialised medical care within a smaller number of entities. To ensure the availability ofmodern healthcare nationwide and the ensuing quality boost as soon as possible, construction of the newbuildings and extensions will commence over a period of a few years. A total of 16 hospital projects areplanned. Investment in the new buildings is based on the requirement for flexibility regarding the financingof IT, devices and apparatus etc. This means that a billion-figure amount has been earmarked for theprocurement and development of new devices and new technologies, which will be allocated on an ongoingbasis over the next 10 years.Concentrating specialist medical care and enhanced research facilities at the new hospitals will hold obviousopportunities for more wide-ranging collaboration with business and industry, including in research. The2010-2020 hospital plan is illustrated inthe figure.Red circles = newbuilds on greenfieldBlue circles = modernisationprojects/extensions/expansions
  19. 19. 19The new hospitals will be established in such a way that they are flexible, meet future demand for treatment,innovation and continuous operational efficiency improvements.Once the hospital investments have been made, Denmark will have a modern and flexible hospital system,which compared with systems abroad will consist of a relatively small number of high-capability units. Thiswill mean high patient volume per unit, consolidation of expertise and improved capacity for the continuityof medical care.3.2: Extensive digitisation – electronic communication between health service partnersThe practice sector in Denmark consists of doctors in clinical practice, specialist doctors in clinical practice,physiotherapists, chiropractors, psychologists, dentists and dental assistants and chiropodists. Generalpractice provides primary care to citizens and serves as the gateway to the rest of the health service as aresource for ensuring rational utilisation of the totality of public health service resources.General practice and the hospital sector in Denmark are characterised by extensive digitisation. Theprevalence of common IT standards means that much of the communication between health servicepartners – hospitals, GPs, specialists, laboratories, local authority domiciliary care services etc. – is electronic: More than 90 per cent of GPs keep electronic health records (EHRs). The practice sector receives 96 per cent of all hospital discharge summaries electronically The practice sector receives 96 per cent of all laboratory test results from the hospitals electronically 85 per cent of all prescriptions are sent to the pharmacies electronically 81 per cent of all referrals are made electronicallyDenmark has a tradition for thorough monitoring and registration of patients who are in contact with thehealth service. Extensive digitisation means that there are excellent opportunities for monitoring patientswithin the practice sector as well as the history of their disease over time. Within the next two years, alldoctors will be required to gather and submit data on their patients regarding diabetes, COLD, cardiacinsufficiency, ischaemic heart disease, stress, anxiety and depression in order that patients with theseconditions may be monitored over time and across the country.A number of international surveys also rank Denmark among the world leaders in healthcare IT. Amongothers, the Information Technology and Innovation Foundation, an independent IT think tank, ratedDenmark, in 2009, as a global leader in the application of healthcare IT along with Sweden and Finland.According to the report Explaining International IT Application Leadership: ”Our analysis of availableliterature and data indicate that three countries—Denmark, Finland, and Sweden—are definitively ahead ofthe United States and most other countries in moving forward with their health IT systems. These threeNordic countries have nearly universal usage of electronic health records (EHRs) among primary careproviders, high rates of adoption of EHRs in hospitals, widespread use of health IT applications, including theability to order tests and prescribe medicine electronically, advanced telehealth programs, and portals thatprovide online access to health information. All three countries have embraced IT as the foundation forreforming their health care systems and have successfully implemented changes that reach every patient.These nations show the transformations possible in health care today through the greater use of IT. ”Across the different sectors in the Danish health service, work is currently in progress to link the various ITsolutions even more seamlessly so that existing patient data can be accessed by different healthcareprofessionals and care staff, irrespective of where in the health service the data were originally entered. Thevision is to achieve a single, cohesive health service in which IT and digital processes support continuity ofcare across hospitals, GPs, local authority domiciliary care services and so forth.Denmark has notably won international acclaim for:
  20. 20. 20 Prevalence of the so-called Medcom standards that have digitised much of the communicationwithin the health service. Prescriptions, referrals and discharge summaries are now on the wholetransmitted electronically Establishment of the health data network for secure electronic communication between all healthservice partners The sundhed.dk web portal, where citizens have access to their own medical data from nationalhealth registers, hospital EHR systems, medication data and so forth. These data can also beaccessed by the patient’s GP Introducing the Shared Medical Card, which gives citizens and healthcare professionals access to acomplete electronic record of each citizen’s current prescription medications. The Shared MedicalCard system simplifies communication concerning medication between health service partners andhelps to reduce the risk of mismedication. The Shared Medical Card system is expected to be rolledout in full at all hospitals and GP surgeries by the end of 20123.2.1: Electronic health records at Danish hospitalsEfforts have been in progress over the last few years to unify and consolidate a large number of hospital ITsystems. The goal of achieving a single EHR system for each region is to be achieved by year-end 2013.3.2.2: TelehealthIn recent years, the use of telehealth within the Danish health service has been stepped up as regards theuse of telehealth in the diagnosis, treatment and monitoring of patients. Telehealth is typically organised as across-sectoral joint programme between the hospital, local authority and GP. Similarly, there has been wideuptake of interpreting services via videoconferencing to hospitals nationwide, and the aim is for remoteinterpreting services to be in use at 90 per cent of all relevant hospital departments by year-end 2012.Measures in the years ahead will be focused on wide-scale dissemination of tried-and-tested technologies sothat the full benefits of telehealth, especially in relation to chronic patients, may be realised. 2011 saw thelaunch of two large-scale telehealth projects devoted to the treatment of patients with chronic conditions(TelecareNord in North Denmark Region and Klinisk Integreret Hjemmemonitorering – Clinically IntegratedHome Monitoring – in Capital Region of Denmark and Central Denmark Region).3.3.3: Unique registers, patient traceability and a culture of collaborationDenmark has a number of unique framework conditions tailored to facilitating high-quality research. Thecountry maintains a number of unique registers and facilities for linking data across registers and databases.In addition, Denmark has a tradition for openness and collaboration.3.3.3: Easy to trace patientsIn Denmark, every single citizen is identifiable by a unique national identity number; effectively a socialsecurity number. The personal number serves as a unique identifier for comparing and updating personaldata across a large number of both public-sector and private-sector IT systems and registers. This facilitatesresearch in, for example, making it possible to perform analyses across the different healthcare registers anddatabases.Public hospitals and general practitioners collect systematic data and contact with the patient is preserved,which permits follow-up to an extent that is scarcely equalled anywhere else in the world, while records inthe national patient register and medication databases permit an outstanding degree of, e.g., patient-
  21. 21. 21compliance monitoring. By linking the different registers, unique knowledge may be acquired on delivery ofmedical care across health service sectors. In addition, Danish research is strongly placed in bioinformaticsand basic pathobiology3.3.4: National registriesAs of 1 March 2012, all data on the state of public healthand data concerning health service activity, economicsand quality will be consolidated at and analysed byStatens Serum Institut (SSI).The registries will be utilised for national and localauthority tasks and for research and analysis purposes inthe field of health.The registries comprise data on the nation’s health,morbidity and mortality, together with data on healthcaresector organisation and economics.The national registries publish statistics on a regular basis,and offer access to data extraction. In addition, extractsfrom the registries are provided for activities such asanalysis, research and planning.3.3.5: The Danish clinical quality databasesThe clinical quality databases contain crucial informationon the national standards of healthcare in the publichealth service.A clinical quality database is a registry containing selectedmeasurable indicators which, based on individual diseasecourses, serve to shed light on either parts of or theoverall performance standards within the health serviceand outcomes for a delimited category of patients. Thesedatabases are all restricted to a diagnostic group, amedical speciality or procedure. This means that separatedatabases are maintained for patients with conditions such as COLD, breast cancer, cardiac insufficiency etc.The data are used for monitoring the quality of treatment in order to assess any underperformance andpotentials for improving quality of care.There are currently 50 national clinical quality databases, which in combination cover approx. 60 categoriesof medical conditions.The data completeness in the clinical quality databases is very high. With a requirement for completeness ofat least 90 per cent, the databases are attractive both nationally and internationally. In addition, thedatabases are closely integrated with the scientific societies and are highly reputed in expert environments.Box 1. National Patient Registry Cause of Death Registry Danish Cancer Registry Healthcare workforce mobility registry Child health database Danish National Diabetes Registry Register of Legally Induced Abortions Medical Licences Registry Central Office of Civil Registration DUSAS (Danish patients treated at foreignhospitals and activities in specialist practice) Danish Medical Birth Registry Rehabilitation IVF registry Municipal health schemes Registry of Congenital Malformations National alcoholism rehabilitation registry National pathology registry National military service registry Registry of substance abusers undergoingrehabilitation National health insurance registry Compulsory psychiatric admission Human tissue utilisation registry Registry of healthcare providers Pharmaceutical statistics registrySource: Statens Serum Institut (www.ssi.dk)
  22. 22. 223.3.6: BiobanksDenmark has been a pioneer in establishing population-based biobanks. Several large biobank cohortsprovide standardised information at enrolment and repeated follow-up of morbidity and mortality throughlinkage to the population-based health data registry systems.Specific Danish resources such as our personal identification number, national healthcare system, registriesdefining genetically informative populations (such as the Twin Registry and the Multiple Generation Registry)and health outcomes (Inpatient registry, Cancer Registry and Cause of Death registry) make Denmarkuniquely suited to a successful biobanking infrastructure. Several Danish biobanking initiatives have achievedinternational visibility and respect for their focus, vision and scientific as well as organisational quality.Biobank collections of tissue, blood and other biological samples from humans are a goldmine of informationfor research and healthcare. Comparison of genetic factors with lifestyle information and environmentalimpacts affecting a population will be instrumental in identifying the causes of some of the major diseases.This knowledge may be key to developing new therapies and tailored medication.Taken together the personal identification number, access to comprehensive biobanks together with accessto various registries containing detailed patient data provide unique opportunities for epidemiologicalresearch and for advancing both basic health science research and clinical drug research. The fact thatDenmark is a world leader in epidemiological research is to a great extent attributable to the nation’s manybiobanks and the unique Danish registries which provide detailed information on the entire population.3.3.7: Culture of openness and collaboration between universities, healthcare professionals and industryIdeas for new therapies and new products often come from doctors, nurses and other users of medicaldevices and technologies. Close, productive collaboration between healthcare professionals and thecompanies and universities that help to translate the ideas into new products is therefore crucial.Denmark has a long-standing tradition for close and fruitful collaboration between these parties based on aculture of open-door policy, a spirit of inquiry and mutual interest in turning new ideas into real products.Many characterise this as a uniquely Danish culture, founded on trust and informal relations, which makesfor flexible, dialogue-based and equitable collaboration on the development and testing of new products.This unique collaborative culture is a precondition for effective collaboration between society, research andindustry, which forms the basis for an effective healthcare industry. The research institutions developcollaborative projects and research platforms, while industry contributes market expertise and actualparticipation in development programmes. This collaborative culture co-exists in Denmark alongside themore formal frameworks for strategic partnerships between researchers and industry.Denmark also distinguishes itself in offering a range of university degree programmes combining medicinewith engineering studies in close partnership with industry. These programmes are offered at the Universityof Copenhagen/Technical University of Denmark, Aarhus University and Aalborg University. Another goodexample is the unique Danish Industrial PhD Programme run by the Danish Agency for Science, Technologyand Information, and a sound formal system for research-industry collaboration contracts within theNational Network for Technology Transfer – techtrans.dk.
  23. 23. 23Collaboration examples from the regionsThere is close collaboration between hospitals and universities on research, training and researchappointments. This collaboration largely concerns combination appointments, research infrastructure andtranslational research. If a company contacts a clinical researcher with a view to conducting a trial at ahospital, it has the certainty that the researcher is qualified, has access to state-of-the-art equipment,methodologies and expertise and has a network within the associated university. In this way, industrygains access to a network within the university setting. The regional structure of the Danish hospital sectorensures that, on making contact with the regions, industry not only has access to a hospital, but, inprinciple, access to all of the region’s hospitals, researchers and patients.Region of Southern Denmark: With its new policy on regional health research, the Region of SouthernDenmark has taken a firm stance on its mission to improve its capacity to form research partnerships withindustry. The latest initiative is called “Southern Danish Health Innovation” (SyddanskSundhedsinnovation). By concentrating regional initiatives within healthcare innovation, the Region iscommitted to achieving the best possible coherence and synergy between research, training, innovationand uptake of welfare solutions at the Region’s hospitals and institutions.Capital Region of Denmark: Capital Region of Denmark is working proactively to support and strengthenclinical research in the healthcare sector. In December 2010, Capital Region of Denmark launched a newinitiative, a ‘single-point-of-entry’ system (SPOE) for clinical trials, with the goal of further facilitatingcollaboration between hospitals and industry based on easier and more direct mutual access for industryand researchers.The new SPOE system for clinical trials works as a gateway for industry to make contact with the rightclinical centres for the purposes of setting up and conducting clinical trials within Capital Region ofDenmark. The system offers to help the industry in early-stage feasibility mapping of clinical trials inDenmark and to identify candidate investigators for specific clinical trials. In addition, the SPOE systemseeks to create research networks, clinical trial units and to foster closer collaboration between relevantpartners in clinical research.The high priority given to clinical trials is emphasised in the new Capital Region of Denmark health policy2012. The SPOE system is also crucial in strengthening collaboration with other relevant clinical trialsupport-units within Capital Region of Denmark and in making the support structure more effective. Basedon dialogue with industry and researchers the intention is to devise and launch further initiativessupporting and strengthening clinical trial collaboration during 2012 and 2013.
  24. 24. 24Chapter 4: A strong tradition and sound framework conditions for clinical trialsIn this chapter you can read about the strong tradition and good framework conditions for conducting clinicaltrials in Denmark. By siting clinical research activities in Denmark, companies gain access to: Highly qualified, reliable and experienced doctors and nurses in research environments of a highinternational standard Interested and suitable trial subjects – combined with sound registries and representative populationstatistics that make it possible to identify and trace the trial subjects A well-organised hospital sector conforming to a high clinical standardo with administrative procedures aimed at collaboration with private-sector pharmaceuticalfirms – and geared to international studieso with excellent research infrastructure geared to clinical research Effective administrative processing by competent public authorities High-quality Danish patient data4.1: Clinical trialsThis above facts has been a contributory factor to Denmark’s ability to attract a great deal of clinical research– beyond what is otherwise merited by our population size. In 2009 Denmark was in 19th placeinternationally in terms of the total number of clinical studies per country. If the number of clinical studies ismeasured in relation to population size, in that year Denmark was in first place1.The fact that the quality of Danish patient data is high is borne out, for example, by the fact that repeatedFDA and EMA inspections of Danish trials have revealed no problems. The standard of quality is underpinnedby the fact that Denmark has been one of the pioneercountries in the introduction of the principles of GoodClinical Practice, and the fact that the country currentlyhas an effective network of competent GCP unitsattached to its university hospitals. Danish investigatorsand other clinical research staff consequently find it agiven to abide by the GCP principles.However, the quality of clinical research in Denmarkhas also been documented as being of a high standard.The volume of Danish scientific publications based onclinical trials is high (measured by per million capita) –and internationally Denmark is surpassed only bySweden on this measure2.Throughout the 1990s, a very large number of clinicaltrials were conducted in Denmark in, e.g., thecardiovascular area. Denmark has also subsequentlydemonstrated its strengths in connection with the1Kortlægning af dansk lægemiddelforskning – Delnotat III Kliniske forsøg (Mapping of Danish pharmaceutical research,sup-report III, clinical trials), Danish Agency for Science, Technology and Innovation, October 2010.2Dansk Sundhedsforskning – status og perspektiver (Danish Healthcare Research – Status and Perspectives), a report bythe Ministry of Health and Prevention, as represented by the executive forum for medical health research and theDanish Agency for Science, Technology and Innovation, June 2008.
  25. 25. 25performance of complex studies requiring extensive coordination and access to high-technology equipmentsuch as scanners. This is one of the reasons why clinical cancer research has risen to prominence in Denmark.In 2010, doctors and companies commenced a total of 452 clinical trials in Denmark. The following lists the10 diagnostic groups most frequently investigated under these clinical trials3:Condition category Number of studies in 2010Cardiovascular diseases 66Cancer 55Diabetes 38Pain 32Gastrointestinal diseases 25Respiratory tract (lung and bronchial) diseases 15Skin diseases 14Viral diseases 14Rheumatic diseases 14CNS diseases 13The Danish Health and Medicines Authority has made a similar listing focussing on clinical drug trials, seeAnnual Report 2011, Clinical trials in humans:http://laegemiddelstyrelsen.dk/~/media/E70DFD80B8A449C2A37806305CC1C802.ashxWith the prospect of significant improvement of the physical settings for the hospital service in Denmarkover the next decade, during which more than DKK 40bn will be invested in new, specialised hospitals, thesettings for clinical research in Denmark will also be greatly enhanced and align the national researchinfrastructure to meet future demands.A significant strength for clinical research in Denmark is that approximately one third of each year of newgraduates of medicine goes on to complete a PhD degree. A large number of such doctors conduct clinicalresearch and, in so doing, gain qualifications which in the international context are outstanding. This meansthat within the Danish health service there are great many professionals who are capable of organising andconducting clinical research at the highest international level.4.1.1: Danish patients are keen to participate in clinical researchMore than 100,000 Danes participate annually in clinical trials and medical research. Approximately 13 percent of the adult Danish population has at one time or another participated at least once in medical researchor a clinical trial4. Looking in k in isolation at clinical drug trials sponsored by private-sector pharmaceuticalfirms, figures from the Danish Association of the Pharmaceutical Industry (Lif) and Dansk Biotek5indicate thatapproximately 20,000 citizens of Denmark participate in such trials every year. The majority participate in3The listing is based on data extracted from www.clinicaltrials.gov4Source: http://www.si-folkesundhed.dk/upload/medicinske_forsoeg_fkj.pdf5Industry association of Danish companies within biotechnology applied to drug development and industrialbiotechnology.
  26. 26. 26clinical phase III trials6. The Danes are generally satisfied with the outcome of their participation in clinicaltrials and the majority would like to participate in trials/research if they were invited to do so again.One significant determinant of positive perceptions of trial participation among subjects is a confidence-inspiring setting for participation. The standard of ethics of the researchers and the companies involved mustbe high, and in Denmark this is achieved by factors such as the tradition for explicit collaboration agreementsbetween the Danish Association of the Pharmaceutical industry and the Danish Medical Association onClinical Drug Trials.Moreover, Danish legislation ensures assessment of such trials by an effective and confidence-instillingsystem of committees on health research ethics, and readily available insurance cover. Reviews of the Danishsystem of committees on health research ethics have reaffirmed the principle of having a lay majority serveamong the committee members, and have served to streamline the processing of applications to conductclinical trials so that it matches the requirements currently made of multinational clinical trials. The existenceof a public-sector patient insurance system covering participation in clinical trials ensures that Danish trialsubjects have easy and flexible access to insurance cover, if, contrary to expectations, they come to any harmas a result of trial participation.In addition, Danish patients exhibit a high degree of trial compliance. In international terms, Danes have ahigh level of educational attainment – illiteracy being rare – and there is consequently great certainty thatboth oral and written information about the study will be understood as intended. An effective infrastructureand readily available health service to which patients are accustomed to seek medical care without demandsfor direct payments is also conducive to good dialogue between the trial subject and doctor/investigator.Finally, flexible arrangements in the labour market appear to reduce the practical barriers that mayotherwise hinder participation in a clinical trial.4.1.2. Single-point-of-entry for clinical trials in DenmarkDenmark is already one of the countries with the most success in recruiting subjects for clinical trials. Butequally, Denmark is among the countries with the highest number – measured per capita – of clinical trials.Denmark wants to retain and develop that position. To that end, in 2011, the Danish regions and Danishindustry established a joint project to create a simple and efficient portal for concluding agreements onclinical trials for the whole of Denmark. This is achieved via a “single-point-of-entry” (SPOE) system thatfacilitates corporate access to preparing and planning clinical trials in Denmark and recruiting trial subjects.The principles of the SPOE system are intended to ensure that industry can make contact with a unifiedhealth service, processes and contracts are standardised and recruitment is streamlined. The model ensuresjoint allocation of roles and responsibilities between regions and industry and consistent information.Via the SPOE system, the five regions are collaborating closely on concluding agreements with industry foraccess to clinical trials with relevant patient groups. Companies that apply via the SPOE system in one regionthereby automatically gain access to legal, medical and research expertise.Within the SPOE system, companies can obtain recommendations regarding potential investigators forclinical trials in all parts of Denmark. The five regional entities are collaborating across regional borders andare therefore in a position to provide comprehensive feedback on potential Danish centres suitable for aproposed clinical trial.6Results from Lif’s and Dansk Biotek’s study of clinical research activities in Denmark in 2009, Lif and Dansk Biotek.
  27. 27. 27What is single-point-of-entry for clinical trials?Single-point-of-entry (SPOE) is a joint procedure for Danish health regions in alliances withindustry (pharmaceutical and medical devices industry) on recruitment of trial subjects andformal agreements to that end. But SPOE is also a service/support function in each region that: acts as the initial and single point of contact for companies seeking to conduct clinicaltrials at Danish hospitals offers a comprehensive and nationally standardised service in the recruitment ofpatients, conclusion of agreements and delineation of roles and responsibilities amongthe parties to the agreement is responsible for advising and informing applicants on the fastest and best approachto preparing to conduct clinical trials in Denmark assists in the conclusion of agreements before the joint trial can be commencedAs a part of the SPOE system, the different clinical trial agreements will in future be processed moreconsistently. This will be achieved both by means of standardised agreements, including non-disclosureagreements, clinical trial agreements and sub-site agreements. Consistency is also safeguarded through aformalised alliance of legal staff, who in each region deal with contracts for clinical trials.Via incentive schemes, the SPOE system will create a number of disease-specific networks and seek todevelop improved registries for rare diseases. In addition, the regions will be launching R&D activitiesfocusing on barriers to recruitment of trial subjects for clinical trials.4.1.3. Quick processing of drug trial applicationsThe Danish authorities assigned to approve clinicaltrials work swiftly and efficiently. Applications forapproval of new trials must be processed within 60days, but the Danish Health and MedicinesAuthority is aiming for processing to be completedwithin a maximum of 30 working days,corresponding to 42 calendar days. From April2012 type A clinical drug trials will be processedwithin 14 working days. In 2011, 97% of allapplicants were replied to within 30 working days.The remaining 3% were replied to at a delay ofmaximum 15 days. In 2010 just less than half of theapplications had their trial approved. Theremaining applications were turned down with aletter of justification, whereupon the final, and inmost cases positive, decision was announcedwithin 60 days. On a yearly basis, some 2 per centof applications are rejected by the Danish Healthand Medicines Authority.
  28. 28. 28Applications to the Danish Health and Medicines Authority may be submitted electronically. The trials areregistered in EudraCT, the European Community database of all clinical trials commencing in Europe from2004 onwards, trial approval status vis-à-vis the national medicine regulatory authorities and healthtechnology assessment bodies together with information on which countries and hospitals are participating.EudraCT is used for information exchange between the European medicine regulatory authorities. Inaddition, much of the content is publicly available via www.clinicaltrialsregister.eu.At the national level, the Danish Health and Medicines Authority liaises with the national and regional systemof committees on health research ethics, regional GCP bodies, the Danish Association of the PharmaceuticalIndustry, the Danish Medical Association and the Organization of Danish Medical Societies (representing 117societies) on clinical trials. The Danish Health and Medicines Authority holds regular briefings and dialoguesessions for companies and researchers, and its staff teach courses and hold seminars etc. in this area.In the case of multi-center trials, the application shall only be submitted to one regional committee, i.e. theregional committee in the area where the principle investigator carries out the research project. Theapproval then covers all Danish sites.4.1.4: Committees on health research ethicsIn order to safeguard the currency and efficiency of the Danish health research ethics committee system, thesystem was restructured as of 1 January 2012.Under the new system, the decision-making process within the regional committees on health researchethics was simplified, and a new national committee was appointed with a number of special powers toensure greater consistency within the committee system. The Act on Research Ethics Review of HealthResearch Projects entails electronic reporting and the possibility of ultimately coordinating the committeesystem’s reporting procedures with the Danish Health and Medicines Authority. In addition, English-languagetrial protocols no longer need to be translated into Danish. The Act allows for fast-track processing of projectsubmissions against payment of a higher fee.The new Act also allows for improved opportunities for conducting research in new situations – but naturallytaking into account the subjects’ safety, rights and well-being. Research solely involving anonymous humanbiological material no longer requires the approval of the system of research ethics committees providedthat the material has been collected in accordance with applicable rules.
  29. 29. 29Chapter 5: World-class researchIn the healthcare area there is access to a strong research environment in Denmark. E.g. withinpharmaceuticals, the medical foundation at both universities and hospitals is very solid. In this chapter youcan read about the healthcare research at the Danish universities. This is followed by a description of anumber of Danish research strengths and finally some of the new research initiatives in Denmark.5.1: Health research at the Danish Universities5.1.1: University of Copenhagen (KU) – Faculty of Health and Medical SciencesAt KU health research is undertaken across the biomedical, natural and social sciences. Human andveterinary health and disease are addressed as one, from a ‘single-health’ perspective. Key areas includemetabolic, neurological and mental health, healthy ageing, lifestyle diseases, cancer and communicablediseases including zoonoses. Basic and clinical disciplines within human and veterinary medicine arecombined in translational and innovative research approaches, supported by a strong Danish platform basedon stringent legal requirements and ethical standards in databases, biobanks and animal models combinedwith world-class laboratories and human test facilities. The close relationship with public-sector and private-sector stakeholders completes the innovation cycle towards the implementation of early diagnostics,prevention and treatment of human and veterinary diseases including personalised treatment and drugdevelopment. For more information about the research and facilities at KU see: http://healthsciences.ku.dk/5.1.2: Technical University of Denmark (DTU)DTU has a wide range of research activities within life sciences, covering medical devices and services as wellas biotechnology, food and veterinary related research. The research has a strong focus on technicaldisciplines and technological development and spans disciplines such as electromechanics, imaging, robotics,nanotechnology and informatics through drug delivery, bioinformatics, nutrition and health to organisationalplanning of healthcare services, construction and facility management and ambient assistive livingtechnologies. DTU has a strong tradition for industry collaboration and access to state-of-the-art labs andfacilities, e.g. a centre for micro- and nanofabrication with clean room facilities and a centre for electronmicroscopy. For more information about research and facilities at DTU, see: www.dtu.dk5.1.3: University of Southern Denmark (SDU) - Faculty of Health SciencesThe strength of SDU lies in research in public health and diseases that adversely affect the population,individual citizens, and society, in order to advance understanding of: the biomedical basis, the incidence and trends within the population, the influence on quality of life and functioning, diagnostics and treatment.This is done by combining advanced biomedical and epidemiological research with research in healthpromotion, prevention, rehabilitation, and methods of examination and treatment. The Faculty of HealthSciences offers a wide range of health-oriented and research-based study programmes at Bachelor, Master,postgraduate, and PhD levels respectively. For more information about research and facilities at SDU, see:http://www.sdu.dk/en/Om_SDU/Fakulteterne/Sundhedsvidenskab.aspx
  30. 30. 305.1.4: Aarhus University (AU) - Faculty of Health SciencesThe Faculty of Health Sciences (Health) at AU consists of five strong departments and houses researchactivities from basic science to applied clinical research and even epidemiological research within a widerange of areas. A hallmark of Health is its close cooperation with Aarhus University Hospital where medicalresearch on a large scale is taking place literally among the patients for the benefit of both patients and theacademic disciplines. Knowledge exchange is a core activity at Health and comprises knowledge sharing andcooperation with private companies, within areas such as: Registry-based Research; Cancer Research;Cardiovascular Research; Translational Research (from molecule to patient); Neurodegenerative Research;and Clinical Trials. For more information about research and facilities at AU, see: http://health.au.dk/5.1.5: Aalborg University (AAU) – Faculty of MedicineThe Faculty of Medicine at AAU is working to create better health, welfare, and growth in close cooperationwith society at large. The Faculty combines basic research and innovation in the fields of health science andtechnology. The research areas range from cell to system, e.g. biomedical technology, medicine, sensorysystems, pain, translational research, drug testing (clinical trials), neural prostheses, rehabilitation,telehomecare, sports science, biomedicine, and medical informatics. In 2013, the Faculty will be establishinga department of clinical science, which will be a part of Aalborg University Hospital. The Faculty houses anumber of highly advanced laboratories and research facilities fulfilling international standards andspecifications. AAU has a long and strong tradition for collaborating with industry partners. For moreinformation, see: http://www.hst.aau.dk/ and http://www.medicine.aau.dk/5.2: Positions of strength in Danish research5.2.1: LifestyleDanish registries are well suited to investigating epidemiological correlations in obesity research and toformulating hypotheses on the development and treatment of obesity. Several European alliances have beenestablished within this field, and several groups hold strong positions within metabolic integrative research,while other groups are engaged in the interaction between food and drugs. The UNIK consortium at theUniversity of Copenhagen within Food, Fitness and Pharma is an example of a multidisciplinary approachinvolving more than 200 researchers. Denmark has some of the best-characterised population studiesinternationally with biological material and genetic research focusing on disease etiology and biologicalmarkers.5.2.2: Diabetes mellitusDiabetes is a chronic disease that presents a major and growing health problem globally. Denmark has astrong tradition in both type 1 and type 2 diabetes research, from epidemiology, pathogenesis and geneticsto treatment of diabetes and its complications. Danish registries and data from the Scandinavianhomogeneous populations have been important tools in translating diabetes research into treatment optionscovering all phases of diabetes. Also, Denmark has a tradition for public-private partnerships and via NovoNordisk has contributed considerably to diabetes research and advances in diabetes therapy worldwide.5.2.3: NeuropsychiatryNeuropsychiatric disorders constitute a major disease and financial burden worldwide and improvedtreatments based on the latest insights into disease mechanisms will be of pivotal importance. Theuniversities and university hospitals in Aarhus and Copenhagen have strong research environments withinpsychiatric genetics and preclinical as well as clinical neuropsychiatry. Furthermore, these centres
  31. 31. 31collaborate closely with Danish pharmaceutical companies such as Lundbeck A/S and Neurosearch on basicpreclinical research as well as drug development targeting the neuropsychiatric area.The outcome of translational research in neuropsychiatry in Denmark is promising; some examples are givenhere. Danish research in psychiatric genetics has identified early chromosomal changes in schizophrenia,which may provide the basis for development of new medical treatment. Brain imaging studies andpsychopathological measurements have provided new insight into and identified biomarkers of diseases suchas depression, obsessive-compulsive disorders and schizophrenia, while preclinical studies have elucidatedsome of the brain mechanisms involved in drug addiction.5.2.4: Cancer researchCancer is the fastest growing major disease in Europe due to the increasing age of the European population.Denmark has strong expertise as well as clinical infrastructures in this important area. As far as prevention isconcerned, Denmark has a very strong cancer registry (actually the oldest in the world) existing for morethan 50 years. With cancer treatment taking place almost exclusively within the public hospital system it ispossible to track both the general population and individual patients to study their exposure toenvironmental factors, and most importantly the relationship between genotype and environment – termedmolecular epidemiology. Denmark also has several strong groups in biomarker discovery together withcomprehensive biobanks (from 2008 a national cancer biobank programme for all branches of oncology) thatare essential for biomarker validation. Denmark has a solid tradition for clinical cancer research withestablished research units at all university hospital oncology departments. The research is conducted acrossmedical specialties and has strong international impact.5.3: Recent major investments in the research infrastructureDenmark is currently investing heavily in a new research infrastructure that will provide unique settings forconducting research at the highest international level.5.3.1: DanStemThe Danish Stem Cell Center (DanStem), opened in the summer of 2011, is currently establishing itself as ahub for international basic, translational and early clinical stem cell research. The aim of DanStem is todevelop novel therapeutic approaches within diabetes and cancer care.DanStem comprises two separate sections: The Novo Nordisk Foundation Section for Basic Stem Cell Biology(BasicStem) and The Section for Strategic Translational Stem Cell Research and Therapy (TransStem).BasicStem will focus on basic experimental research into the biology of pluripotent stem cells, the formationof beta cells and the special properties of cancer stem cells. This section is funded by The Novo NordiskFoundation. TransStem will translate promising basic research results into new strategies and targets for thedevelopment of new therapies for cancer and diabetes and move these fields towards early clinicalapplication. This section is funded by a grant from the Danish Council for Strategic Research. Together, thesections will give researchers at DanStem the opportunity to perform cutting-edge basic stem cell researchand translate this into novel therapies for two very major global diseases – diabetes and cancer. For moreinformation, see: http://danstem.ku.dk/
  32. 32. 325.3.2: The Danish National BiobankDenmark is at the very frontier of epidemiological research. This is to a large extent due to the unique Danishregistries which provide detailed information on the entire population. With the establishment of a majornational biobank and the possibility of linkage between biological specimens and information contained inthe Danish registries, Danish research has been given new and competitively unique possibilities.Statens Serum Institut (SSI) has received a large research grant from The Novo Nordisk Foundation and theMinistry of Science, Technology and Higher Education to establish a national biobank. The goal is tostrengthen the Danish research infrastructure and thereby the conditions for Danish public health researchand international research collaborations. The Danish National Biobank opened in March 2012 and is one ofthe worlds largest biobanks and internationally an absolutely unique resource for the benefit of research inthe etiology, prevention and treatment of diseases.The Danish National Biobank consists of the following three entities: The Danish Biobank Register: a Danish biobank register with detailed information on the specimensmade available by the Danish health services and the largest research biobanks, including specimensat SSI. A large biobank at SSI: a large national biobank based on the specimens submitted to Statens SerumInstitut (SSI), the national institute for prevention and control of infectious diseases and congenitaldisorders. The material currently includes more than 6 million specimens. In addition to specimenreception, storage and dispensing, the biobank will undertake developmental projects to enhancethe capability for extracting valuable information from biological material. A coordinating centre: to coordinate compilation of the biobank register and the new nationalbiobank with subsequent responsibility for the daily management of the activities. The centre willalso advise and assist researchers on use of the biobank register and the national biobank.Establishment of the Danish National Biobank will facilitate effective use of the many biological specimenscollected by the public health sector. Researchers will benefit from a unique overview of and access to morethan 15 million biological specimens in existing as well as future collections. Projects approved by thenational system of committees on health research ethics and the Danish Data Protection Agency will obtainpermission to link biological material from one individual with the vast amount of further informationavailable in the national registers within public health for example. The Danish National Biobank is a jointinitiative between Statens Serum Institut, hospitals, universities and other public research institutionscollecting or using biological material. For more information, see: http://www.ssi.dk5.3.3: Other investments in research infrastructureIn addition, Denmark is making a large number of other research infrastructure investments. Examplesinclude: 1) European Spallation Source, 2) a proposed National Centre for Particle Therapy, 3) InternationalScience City at North Campus, 4) Center for Protein Research, The Danish Stem Cell Center and The NovoNordisk Foundation Center for Basic Metabolic Research, all at the University of Copenhagen; 4) Newhospital buildings worth more than DKK 40bn which will renew just under a third of the Danish hospitalsquare meterage by 2020. The establishment of the multidisciplinary Danish Platform for Large-scaleSequencing and Bioinformatics coordinated from COBIS in Copenhagen is another example of a uniqueresearch initiative that is currently attracting international research investments.
  33. 33. 33Chapter 6: Denmark a great place to do businessIn this chapter, you can read more about doing business in Denmark. With a corporate tax rate of 25 percent, competitive business costs and some of the world’s most flexible labour market conditions, Denmark isan attractive choice for foreign investors. Add to this a very simple procedure for establishing a business andthe presence of a highly skilled and motivated workforce. The result: some of the best possible conditions fordoing business.Top 5 reasons for locating your business in Denmark:• In Denmark you benefit from Europe’s most flexible labour market• In Denmark you have access to a highly skilled an educated workforce• In Denmark it is easy to establish a business• In Denmark there is no red tape a very low level of corruption• In Denmark there is easy access to researchers6.1.1: Europe’s most flexible labour marketAccording to the IMD World Competitiveness Report 2011, Denmark offers the highest labour marketflexibility in Europe and is ranked 1stin the world. Scaling a business up or down can be implemented moresmoothly in Denmark than anywhere else in Europe.Source: IMD World Competitiveness Yearbook 2012Compared to other European countries, the Danish rules for termination of contracts are very liberal. Theemployer is entitled to dismiss skilled and unskilled workers at any time, without incurring costs, making iteasier for an individual business to adjust the size of its workforce in Denmark. The Danish “flexicurity”model offers extensive flexibility in hiring and firing practices, which is unique in Europe. Wages and workhour rules are negotiated between labour market organisations or directly in the company to best addressmarket conditions and business needs. In Denmark most people are insured against unemployment and
  34. 34. 34thereby guaranteed a high level of social security, which results in a relatively high degree of labour marketflexibility.6.1.2: Highly skilled, well-educated populationDenmark is highly aware of the importance of education and a tradition for life-long education at every levelof employment. The availability of skills is vital for a well-functioning labour market. The Danish Governmentand private-sector industry in Denmark give high priority to staff training and upgrading of qualifications,including for the unemployed. Denmark has a diverse range of educational institutions, business schools,universities etc. in which the Government has invested heavily. The public education system is free andprivate institutions offer high quality at low costs. As a result, Denmark has a well-educated population witha high proportion of university graduates. The percentage of the population that has attained at least uppersecondary education is 80 per cent, which is among the highest rates in the European Union.The Danish population has excellent foreign language capabilities, as Denmark is relatively small andinternationally oriented. There is no problem finding multilingual staff in Denmark since 80% of theworkforce speaks English. According to the IMD World Competitiveness Report 2011, Denmark is placed 2ndin the world among non-English speaking countries, on English proficiency.6.1.3: Business culture & work habitsCompanies with relatively flat organisational structures are very common in Denmark, which results in higherresponsibility for individual employees. In general, the Danish workforce is perceived as highly motivated byforeign companies operating in Denmark. Danish employees are characterised as being healthily self-critical,with a will to learn and a commitment to improvement. Also, they work with equal ease eitherindependently or in project-oriented teams. A strong sense of responsibility in turn leads to increasedproductivity and higher earnings. A high level of education combined with independence and flexibilitymakes the Danish workforce capable of taking on tasks, which in other countries would be the preserve ofuniversity-trained specialists. Such skills are of crucial importance to companies in today’s business world.6.1.4: Easy to establish a businessDenmark is among the world’s best locations for doing business. Forbes has ranked Denmark in top 5worldwide for the fourth straight year (Forbes Best Countries for Business 2011), and the World Bank’s “Easeof doing business Report” ranks Denmark 1stin Europe and 5thin the world (Economy Rankings 2012).Denmark offers foreign investors a wide range of possibilities for establishing a business, enabling them totailor their investment plans to suit their business needs. Incorporation of a company is simple and can bedone online from one day to the next.6.1.5: Effective infrastructureDenmark has an effective and well-developed infrastructure, allowing companies to operate easily by air, seaand land. From Copenhagen and the surrounding Øresund Region you are within 5-hour access of more than46 million people giving you an immediate advantage compared to e.g. the corresponding 18 million peopleaccessible from Stockholm.Denmark also has world-class IT infrastructure with some of the world’s highest ICT penetration rates formobile, broadband and PC.
  35. 35. 356.1.6: Denmark is a safe place to liveA characteristic feature of the Danish working and family life is quality – Denmark is a safe and secure societywith free public health and educational services and a clean environment. This is why Denmark is rankedsecond on quality of life in the annual Monocle quality of life survey (Monocle 2010).6.1.7: Low level of corruptionDenmark is by all accounts one of the least corrupt countries in the world. According to the annualTransparency International index of perceived national corruption Denmark does well in ratings of corruptionand anti-corruption efforts. According to the IMD World Competitiveness Report 2011, Denmark alsooccupies a first place in the list of least corrupt countries in the world.Source: IMD World Competitiveness Yearbook 20126.1.8: Easy access to researchersOne big advantage of a small country like Denmark is that networking is easier, with less separation betweenthe scientist or scientific entrepreneur and the decision makers, such as government ministers, policy-makers, and industry leaders. This is conducive to productive relations between academia and industry,which is a distinct advantage for those in translational medicine seeking to move basic research into clinicalapplications.Universities, university hospitals, research centres and private companies of various sizes, all work together.This is a productive form of interaction that is not seen in many other countries. This culture is also fosteredby the educational institutions, where the aim is to teach students to work together in an interdisciplinarycontext, resulting in efficient teamwork and innovative research and products.For more information on establishing a business in Denmark, see: http://www.investindk.com/
  36. 36. 366.2: Human resources within the pharmaceutical industryDenmark has a large pool of human resources with high-level expertise and advanced qualifications within awide range of pharma, biotech, medtech and other healthcare industries.Within the pharmaceutical industry, the employees of Danish pharmaceutical firms are characterised by theirhigh level of educational attainment. Around 25 per cent of the some 20,000 employees have a long-cycletertiary education and just under 900 hold a PhD degree. The majority are recruited from Danish universities,although there is now increasing success in positioning Medicon Valley as a research powerhouse whichfacilitates international recruitment.Looking at clinical research in isolation, in 2010, just under 1,500 individuals had jobs in clinical research atDanish pharmaceutical firms, of whom just over 200 were engaged in clinical research sited in Denmark.For Danish undergraduates, the pharmaceutical industry is a highly visible goal. 50 per cent of all pharmaceutical PhDs in the Danish labour market work in the pharmaceuticalindustry. 37 per cent of all Danish pharmacists, 32 per cent of all human biologists, 21 per cent of biochemistsand 14 per cent of chemical engineers work in the pharmaceutical industry.This favourable rate of graduate employment has evolved in conjunction with the universities, which areproactive in meeting demand for pharmaceutical experts.Within the last decade, total intake on PhD programmes doubled from 1,289 PhD enrolments in 2003 to2,480 new enrolments in 2010 – the majority of the new PhD enrolments being in the disciplines of naturalscience, technology and health science. Similarly, the number of pharmacists is expected to increase by justover 25 per cent from the year 2000, bringing the number of pharmacists up to 4,000 by the year 20207.The image of an ever-more significant pharmaceutical industry is also reflected in the fact that the Danishuniversities increasingly offer masters-equivalent programmes geared specifically to employment in thepharmaceutical industry. The latest pharma-oriented degree programmes include: Molecular Biomedicine,Nanobioscience, Biomedicine, Biotechnology, Bioinformatics, Pharmaceutical Chemistry and PharmaceuticalScience.7Kortlægning af dansk lægemiddelforskning – Delnotat IV – Rammebetingelser, i form af højtuddannede kandidater ogph.d.er inden for lægemiddelforskning (Mapping of Danish pharmaceutical research, sub-report IV, frameworkconditions; highly-qualified MSc-level graduates and PhD holders in pharmaceutical research), Danish Agency forScience, Technology and Innovation, October 2010.
  37. 37. 37Chapter 7: Financing sourcesDenmark has a range of financing sources, ranging from state incentive programmes and private investors tobanks, venture capitalists and institutional investors. In this chapter you can read about the vast funding andfinancial potentials open to your company in Denmark.7.1: Denmark and free tradeAs Denmark supports free trade and welcomes foreign investors, companies enjoy a number of advantageswhen setting up in business in Denmark. In addition, Denmark offers excellent opportunities for public-sectorfunding for establishing public-private research partnerships such as via The Danish National AdvancedTechnology Foundation, the Danish Council for Strategic Research and the Industrial PhD Programme.Denmark offers: International as well as Danish companies can apply on equal terms for the financing and incentivesavailable Denmark complies with the European Union directives on free and fair competition within the EU Comprehensive R&D fundingCompanies from all industry sectors in Denmark can apply for funding and financial incentives for R&D.Below is a list of the funding opportunities within the healthcare sector.7.2: Funding opportunities in Denmark within the healthcare sectorName of fund Focus area PartnerRequirementsFor more informationThe DanishCouncil forStrategicResearch:ProgrammeCommissionon Health,Food andWelfareFunding for projects in biologicalmanufacturing, connection betweenfood, health, lifestyle and drug resistanceas well as health initiatives to counterexternal influences. Emphasis will beplaced on high relevancy as well as oneffects and benefits. There will also beemphasis on the research beingconducted as an integrated interactionbetween public and private sectorresearch as well as on co-financing.Danish Agency forScience,Technology andInnovationhttp://en.fi.dk/fundingThe DanishCouncil forIndependentResearch:MedicalSciencesFunds specific research activities coveringall aspects of basic, clinical and socio-medical research geared towards humanhealth and disease.Danish Agency forScience,Technology andInnovationhttp://en.fi.dk/funding
  38. 38. 38The DanishCouncil forIndependentResearch:NaturalSciencesFunding for projects geared towards basicscientific issues within natural sciences,computer science and mathematics.Danish Agency forScience,Technology andInnovationhttp://en.fi.dk/fundingThe DanishCouncil forStrategicResearch:ProgrammeCommissiononIndividuals,Disease andSocietyFunding of strategic research with theobjective of finding solutions tosignificant challenges in the field of healthand thereby guaranteeing a high standardof treatment and disease prevention aswell as optimizing the organisation ofhealth service. Emphasis will be placed onhigh relevancy as well as on effects andbenefits. There will also be emphasis onthe research being conducted as anintegrated interaction between publicand private sector research as well as onco-financing.Danish Agency forScience,Technology andInnovationhttp://en.fi.dk/fundingThe DanishCouncil forStrategicResearch:ProgrammeCommissionon StrategicGrowthTechnologiesFunding for projects devoted tointerdisciplinary applications ofnanotechnology, biotechnology andinformation and communicationtechnology, including intelligent solutionsfor society.Danish Agency forScience,Technology andInnovationhttp://en.fi.dk/funding

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