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The heart of life sciences

for research and business

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Table of contents

Executive Summary ............................................................................................................... 4

Chapter 1: 10 Good Reasons for Choosing Denmark for R&D and business activities........................................ 6

1.1: 10 good reasons for choosing Denmark as the location for pharmaceutical research activities ..................... 6

1.2: 10 good reasons for choosing Denmark for your medical devices business ........................................... 8

1.3: 10 good reasons for investing in Denmark and the Danish eHealth industry ....................................... 10

Chapter 2: A world-leading healthcare industry .............................................................................. 12

2.1: The pharmaceutical industry ........................................................................................... 12

2.2: The biotech industry .................................................................................................... 15

2.3: The medical devices industry ........................................................................................... 16

2.4: The eHealth industry .................................................................................................... 17

Chapter 3: A strong healthcare system ........................................................................................ 18

3.1: New hospitals and robust hospital services structure ................................................................ 18

3.2: Extensive digitisation – electronic communication between health service partners .............................. 19

3.2.1: Electronic health records at Danish hospitals .................................................................... 20

3.2.2: Telehealth .......................................................................................................... 20

3.3.3: Easy to trace patients .............................................................................................. 20

3.3.4: National registries .................................................................................................. 21

3.3.5: The Danish clinical quality databases ............................................................................. 21

3.3.6: Biobanks ............................................................................................................ 22

3.3.7: Culture of openness and collaboration between universities, healthcare professionals and industry ....... 22

Chapter 4: A strong tradition and sound framework conditions for clinical trials .......................................... 24

4.1: Clinical trials ............................................................................................................. 24

4.1.1: Danish patients are keen to participate in clinical research ..................................................... 25

4.1.2. Single-point-of-entry for clinical trials in Denmark ............................................................... 26

4.1.3. Quick processing of drug trial applications ....................................................................... 27

4.1.4: Committees on health research ethics ........................................................................... 28

Chapter 5: World-class research ............................................................................................... 29

5.1: Health research at the Danish Universities ............................................................................ 29

5.1.1: University of Copenhagen (KU) – Faculty of Health and Medical Sciences ..................................... 29

5.1.2: Technical University of Denmark (DTU)........................................................................... 29

5.1.3: University of Southern Denmark (SDU) - Faculty of Health Sciences ........................................... 29

5.1.4: Aarhus University (AU) - Faculty of Health Sciences ............................................................. 30

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5.1.5: Aalborg University (AAU) – Faculty of Medicine ................................................................. 30

5.2: Positions of strength in Danish research .............................................................................. 30

5.2.1: Lifestyle ............................................................................................................. 30

5.2.2: Diabetes mellitus ................................................................................................... 30

5.2.3: Neuropsychiatry .................................................................................................... 30

5.2.4: Cancer research .................................................................................................... 31

5.3: Recent major investments in the research infrastructure ............................................................ 31

5.3.1: DanStem ............................................................................................................ 31

5.3.2: The Danish National Biobank ...................................................................................... 32

5.3.3: Other investments in research infrastructure .................................................................... 32

Chapter 6: Denmark a great place to do business ............................................................................ 33

6.1.1: Europe’s most flexible labour market ............................................................................. 33

6.1.2: Highly skilled, well-educated population ......................................................................... 34

6.1.3: Business culture & work habits ................................................................................... 34

6.1.4: Easy to establish a business ....................................................................................... 34

6.1.5: Effective infrastructure ............................................................................................ 34

6.1.6: Denmark is a safe place to live .................................................................................... 35

6.1.7: Low level of corruption ............................................................................................ 35

6.1.8: Easy access to researchers ........................................................................................ 35

6.2: Human resources within the pharmaceutical industry ............................................................... 36

Chapter 7: Financing sources .................................................................................................. 37

7.1: Denmark and free trade ................................................................................................ 37

7.2: Funding opportunities in Denmark within the healthcare sector .................................................... 37

7.3: Aid schemes for seed capital and research financing ................................................................. 41

The Authors ..................................................................................................................... 42

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Executive Summary

Start with Denmark, the heart of life sciences for research and business

For a great many years Denmark has constituted an international health laboratory, attracting international businesses and researchers. Some of the main reasons are stated below:

The presence of several different types of healthcare industries makes Denmark a promising location for investing in healthcare research

The Danish healthcare industry is strongly placed: its pharmaceutical industry has the third-largest pipeline 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 publications and 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 Danish personal identity number system and the comprehensive national health registries and quality databases, it is possible to monitor patient disease history over time. This offers unique conditions for clinical research

Denmark is poised for a comprehensive modernisation of its national health service which will involve 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 most flexible labour market conditions, Denmark is an attractive choice for foreign investors. Add to this a very simple procedure for establishing a business and the presence of a highly skilled and motivated workforce. The result: some of the best possible conditions for doing business

Furthermore, in Denmark there is a long-standing tradition for efficient public-private partnerships in areas such as development and testing of healthcare and welfare solutions. This applies both to the pharmaceutical industry and in medical technology, where the hearing aid segment may be held up as a shining example that has resulted in some 40 per cent of the world’s hearing aids being developed and manufactured in Denmark.

There is keen political focus on creating framework conditions conducive to research and business development in healthcare and welfare. Investment in research and innovation is a key criterion for securing national revenue in the future. The Danish Government will be increasing public-sector investment in research 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 fully achieved 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 welfare technology, and why Denmark is an excellent place to do business.

The report presents the reader with an introduction to the Danish healthcare industry, covering the pharmaceutical industry, the biotechnological industry, the medical technology industry and the eHealth industry. Starting with a presentation of ‘Top 10 Reasons’ for choosing Denmark for research and business activities, the report is then divided into chapters focusing on the different aspects of the healthcare industry.

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The chapters provide information on the following areas:

- A world-leading healthcare industry; facts and figures on the pharmaceutical industry, the biotechnological industry, the medical technology industry and the eHealth industry in Denmark

- A strong healthcare system; information on the framework conditions of the Danish healthcare system

- A strong tradition and good framework conditions for research; information on conducting clinical trials 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 doing

business in Denmark

To learn more about investing in Denmark, please contact the Life Sciences team at Invest in Denmark: http://www.investindk.com/

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Chapter 1: 10 Good Reasons for Choosing Denmark for R&D and business activities This chapter presents the ‘Top 10 Reasons’ for choosing Denmark for research and business activities. The chapter 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 activities

1. Unique framework conditions for the pharmaceutical industry Denmark is a modern knowledge-based society with excellent framework conditions for the research-based pharmaceutical industry – including a flexible labour market, favourable taxation rules for research-based businesses, a well-educated population, a low level of corruption, a high level of security and stable macroeconomic conditions. Pharmaceutical products constitute Denmark’s largest export commodity. Denmark has excellent framework conditions in the shape of low corporate tax (25%), tax breaks on research partnership expenses, and international researchers benefit from a special low tax rate (26%). Since 2009, Denmark has fulfilled the Barcelona objective of investing at least 3 per cent of GDP in R&D. Private investment currently accounts for just under 2 per cent, and public-sector investment approx. 1 per cent. The Danish Government’s goal is for at least 1 per cent of GDP to be spent on public-sector research investment.

2. Denmark ranks 2nd internationally by the number of publications based on clinical trials and pharmaceutical research Denmark 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 high output of frequently cited scientific articles in leading international journals.

3. Tradition for close public-private partnerships Danish universities and hospitals are open and accustomed to collaborating with private-sector businesses.

4. State investments in public-private research partnerships Denmark offers excellent opportunities for public-sector funding for establishing public-private research partnerships such as via the The Danish National Advanced Technology Foundation, the Danish Council for Strategic Research and the Industrial PhD Programme.

5. Highly qualified labour In Denmark it is easy to recruit staff with the right medical expertise at the highest international level. Denmark has a large and rising number of masters’-equivalent and PhD degree holders from the universities. In addition, Danish pharmaceutical and biotech companies constitute an international powerhouse conducive to recruitment of international employees.

6. Heavy investment in new research infrastructure creates unique frameworks for pharmaceutical research in Denmark Denmark is currently making a large number of research infrastructure investments. Examples include: 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 Cell Center and The Novo Nordisk Foundation Center for Basic Metabolic Research, all at the University of Copenhagen; 4) New hospital buildings worth more than DKK 40bn which will renew just under a third of the Danish hospital square meterage by 2020: 5) the establishment of the multidisciplinary Danish Platform for Large-scale Sequencing and Bioinformatics.

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7. World-class patient registries, civil registries and biobanks In Denmark, all citizens are identifiable by a unique personal ID number system. In addition, there is access to comprehensive biobanks and to large registries containing detailed patient data, which offer unique opportunities for epidemiological research and support for both basic scientific research in pharmaceuticals and clinical pharmaceutical research.

8. The best clinical trial subjects Danish 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 standard In Denmark there is access to a well-organised, public-sector financed health service of a high clinical standard, with qualified, reliable and experienced doctors and nurses in clinical research environments of a high international standard.

10. Efficient public authorities Efficient administrative procedures performed by competent public-sector authorities ensure rapid approval of clinical pharmaceutical trials by the Danish Health and Medicines Authority and the national and regional system of committees on health research ethics.

GlaxoSmithKline On Invest in Denmark’s homepage Mike Connell, former V.P. and General Manager of GlaxoSmithKline Denmark, explains why one of the world's leading research-based pharmaceutical companies has chosen to invest in Denmark: http://www.investindk.com/News-and-events/News/2012/Watch-GSK-explain-why-they-have-invested-in-Denmark MSD Denmark “In Denmark, we have great success in recruiting participants for megatrials in cardiology, osteoporosis and vaccines. We have positive examples of over-recruitment, and compared with other countries we have the most impressive retention rate in clinical trials. In Denmark, no patient is ever lost to follow-up – which is a major problem in many other countries. All of this means measurable results, and is the reason why we have 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 a highly competitive market one of the preconditions for retaining investment in clinical research is a willingness to adopt new, innovative therapies when they come out on the market, otherwise there is no investment 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 due to our investigators who are swift to make a decision on trial viability and because we have the Danish Health and Medicines Authority and a system of committees on health research ethics that make rapid and professional trial assessments. In recent years, we have also managed to include more patients than originally planned. When our headquarters select countries for conducting trials in, predictability is a key factor. Based on the above, we know that this is where Denmark holds its own.” (Malene Kelstrup, Medical Director, Sanofi-Aventis Denmark)

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1.2: 10 good reasons for choosing Denmark for your medical devices business

1. Strong, large and well-established medical devices industry

The Danish medical devices industry is well-reputed abroad for a number of leading global companies in consumables, hearing aids, diabetes devices and diagnostic devices. These companies are prominent in Danish 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 SMEs

The core of the Danish medical devices industry is made up of a large number of small and medium-sized enterprises comprising innovative manufacturers, distributors and international sales companies, subsidiaries and consultancies. The many players in the industry make for a dynamic environment of clusters and networking opportunities.

3. Well-developed innovation environment

The medical devices industry is sustained by innovation and product R&D, and Danish enterprises benefit from an array of well-established innovation centres distributed throughout Denmark.

4. Strong medical devices industry clusters with research centres and well-qualified staff

Across Denmark, regional authorities, universities and science parks are investing heavily in the development of medical devices industry clusters and innovative research environments in an interaction between businesses, universities and hospitals – these clusters foster the development of new technologies and the emergence of new businesses.

5. Productive tradition and culture for collaboration between industry, healthcare personnel and researchers

Denmark has a wholly unique tradition and culture for collaboration, open-door policy and a spirit of inquiry in fostering new partnerships between industry, healthcare personnel and researchers.

6. Unique capability in developing and incorporating design in product development

The strong Danish design tradition extends to R&D in medical devices and is a unique competitive parameter in this sector. User-friendly and intuitive design is an increasingly crucial element in medical devices R&D, and in this field Denmark has a unique position of strength.

7. Large-scale redevelopment of Danish hospitals up to 2020

The Danish hospital sector is poised for a comprehensive programme of newbuilds and extensions to the nation’s hospitals, with just under 30 per cent of the total hospital square meterage due for renewal by 2020. Substantial funds have been earmarked for new technologies, equipment and infrastructure in extension of the building works.

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8. Cooperative and modern health service

The Danish public health service gives high priority to partnerships with business and industry. In the light of the hospital construction works, immediate opportunities exist for increased cooperation on developing 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 workforce

Denmark has a very well-qualified workforce within the life sciences area as a whole, with recruitment opportunities from the universities as well as specialists and experts from the nation’s large life sciences sector.

10. Efficient and service-oriented authorities

The Danish authorities, among which the Danish Health and Medicines Authority is a key partner for new medical devices businesses, are known for their rapid, efficient and service-oriented administrative procedures, extensive digitisation and self-service, which help to ensure the best possible framework for establishing and running a business in the country.

Attention

“One significant area is our ability in productive innovation environments to jointly come up with highly patentable 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 to match.” (Jens Peter Andersen, Quality Manager and Project Manager, Pallas Informatik)

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1.3: 10 good reasons for investing in Denmark and the Danish eHealth industry

Invest in Danish E-health; the settings are second to none

1. Test on a small scale among the best

Use Denmark as a testing ground; the business risks are manageable in a country with only 5.5 million citizens. Denmark is representative of the leading markets in the world, with fierce competition between the best E-Health companies. Solutions selling well in Denmark can be expected to do well everywhere.

2. Public-sector funding

Public-sector funding is available for E-health solutions that test new grounds for delivering health services faster and cheaper. The Danish Government is investing EUR 5.6bn (EUR 1,000 per capita) in an ambitious plan to establish new, digitised hospitals. The funding is earmarked for public-private partnerships.

3. The infrastructure of tomorrow

With almost universal penetration of broadband, the Danish digital infrastructure is among the best in the world. Denmark offers a unique opportunity for testing demanding solutions in a national setting with the infrastructure of tomorrow.

4. Empowered patients and e-ready staff

Danish citizens are among the most e-ready in the world. In all public- and private-sector domains digitisation has been widely adopted, including within E-health-services at hospitals, at GP surgeries, in municipalities and in people’s own homes. Highly skilled staff across the health sector make testing of innovative solutions possible.

5. Patients first

Danish solutions are tested for their ability to put the patient first. Denmark has a long-standing tradition for designing solutions that span sectoral barriers, creating coherence in the treatments and putting the patient first.

6. Standards-driven integration means ready for export

Denmark is committed to adhering to international standards for data-processing and sharing. This makes it easier to both import and export solutions worldwide. In Denmark we test and deploy in settings with challenging demands for integration. Solutions capable of delivering results in Denmark are known worldwide for their ability to integrate with solutions in use abroad.

7. National references readily attainable

Regarding eHealth solutions, the public sector is aware of the value of strong national reference cases. In combination with a coordinated public effort for nationwide usage of solutions demonstrating positive outcomes, national references are readily attainable for companies.

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8. Companies willing to partner up

Given the relatively small size of the majority of the Danish E-health companies, international partners ready to invest in partnerships stand to benefit from shortcuts to Danish solutions and markets.

9. “Danish inside” means assured data protection

Denmark has a long tradition for secure handling of large data volumes. Companies can use the Danish skilled developers as a springboard for readying their solutions to meet the stringent international requirements for personal data protection. If it’s secured in Denmark, it’s done right.

10) Safe haven for investments

Place your investments in Denmark; it is a safe haven in a time of international financial crisis.

Strategic Intelligence Monitor on Personal Health Systems

SIMPHS research has identified Denmark, together with England and Scotland, as “leaders in terms of mainstream telehealth in Europe in a combination of demand-side factors, high eHealth deployment, good governance models and in terms of the commitment of key stakeholders in the different tiers of the care and value chain.”

Source: Strategic Intelligence Monitor on Personal Health Systems (SIMPHS). European Commission, Joint Research Centre, Institute for Prospective Technological Studies, March 2012

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Chapter 2: A world-leading healthcare industry In this chapter, you can read more the healthcare industry in Denmark. The chapter covers the pharmaceutical industry, the biotechnological industry, the medical technology industry and the eHealth industry.

2.1: The pharmaceutical industry

Research, development and manufacture of pharmaceutical products represent one of Denmark’s commercial strengths. Danish pharmaceutical companies rank among the absolute world elite in therapeutic areas, such as diabetes, depression, skin disorders and allergies, while subsidiaries of all the major international pharmaceutical firms are also present in Denmark where many of them have substantial clinical research activities.

This means that from a global perspective, Denmark is at the very forefront in pharmaceuticals R&D and pharmaceutical exports. In 2010, Danish firms had more than 120 pharmaceutical candidates in the clinical pipeline (in either phase I, II or III), which in absolute figures and in a European context is surpassed only by the UK and Germany (source: Ernst & Young, German Biotechnology Report 2011, April 2011). Measured per capita, Denmark has, without a doubt, the biggest pipeline in Europe.

Danish pharmaceutical exports have been increasingly sharply over many years. In 2010, exports topped the DKK 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 that

account 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).

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The quality of Danish pharmaceutical research is also at the top internationally. The number of scientific articles per 1,000 capita is the second-highest in the world, and the impact of those publications is surpassed only by Switzerland (see figures below). Measured per capita, Denmark can lay claim to being the country in the world with the second-largest volume of publications based on pharmaceutical research. Citation analyses reveal that the impact of Danish publications based on pharmaceutical research is significantly above the OECD average, surpassed only by Switzerland. Danish publications are among the most frequently cited in the world.

Source: Report on bibliometric mapping of Danish pharmaceutical research 2003-2008

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Measured 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), Danish Agency for Science, Technology and Innovation, October 2010.

The Danish pharmaceutical companies are involved in a range of research activities in close collaboration with Danish universities and the public health service. Private-sector pharmaceutical research as a whole accounts for 23 per cent of all private-sector research in Denmark – in absolute figures; the pharmaceutical industry in Denmark invests more than DKK 8bn per annum in research.

This means that within the international context, private-sector pharmaceutical research in Denmark is distinctive in that it accounts for a very large share of total business and industry R&D investments. Looking at 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 clinical research activities at Danish hospitals.

The long-standing tradition and solid foundation for pharmaceutical research in Denmark have also facilitated the establishment of a number of biotech companies, for example, in the Danish-Swedish Medicon Valley cross-border cluster, which in turn has helped to place Denmark firmly on the world map.

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2.2: The biotech industry

As stated in the previous section, the long-standing tradition and solid foundation for pharmaceutical research in Denmark have facilitated the establishment of a number of biotech companies. More than 150 years ago, Danish agriculture sowed the seeds for a national research industry and since then, research methods have been evolving continually in Denmark.

Medicon Valley, one of Europe’s top three sites for biotech innovation alongside Cambridge in the United Kingdom and Basel in Switzerland, spearheads the Danish biotech cluster with a strong presence and close collaboration between universities, hospitals and companies. The Medicon Valley hub is the area spanning Eastern Denmark and South-Western Sweden and is connected via the Øresund bridge. As one of Europe's strongest life science clusters, Medicon Valley is home to a large number of life science companies and research institutions located within a very small geographical area.

Medicon Valley represents the entire (bio) pharmaceutical value chain from target identification through preclinical and clinical development to manufacturing. The presence of large pharmaceutical companies in the cluster has a positive effect on SMEs when it comes to research initiatives and research talents. The main focus 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 medicine development.

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 science

Facts about the Danish pharmaceutical industry:

Number of companies: 170 marketing authorisation holders. The 20 largest accounts for two-thirds of the market.

Number of employees: Approx. 20,000 employees (creates a total of approx. 70,000 jobs, including employees in sub-industries). In the period 1999-2008, the number of employees increased by more than 30%. Measured by the number of employees relative to the size of the Danish population, Denmark has the second-largest pharmaceutical industry in the world.

Exports: Worth just over DKK 57bn in 2011. Pharmaceutical exports currently represent Denmark’s largest export sector, approx. 10% of total Danish exports. Since 1997, pharmaceutical exports have more than tripled. Approx. 90% of Danish pharmaceutical production is exported.

Sales 2010: DKK 100bn in Denmark. [Based on the Danish flagship companies’ total sales + subsidiary-based companies’ sales in Denmark.]

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More than 40,000 people are employed in the life sciences sector in Medicon Valley and there is a strong tradition and culture for networking and collaborating in the region. This also facilitates informal networking and meetings between the cluster’s stakeholders.

2.3: The medical devices industry

The 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 is innovation-led and characterised by a short route from concept to finished product and a rapid product lifecycle. Measured per capita, Denmark has one of the largest medical devices industries in Europe in terms of 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, and apparatus and hearing aid manufacturers. In addition, the industry consists of a large number of small and medium-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 in Denmark via sales companies and subsidiaries.

The Danish medical devices industry upholds a long-standing tradition for close and systematic collaboration with health professional environments at hospitals and with university research environments, and is at the leading 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, rehab and assistive devices industries, and there is widespread overlap between multiple companies and collaboration across the different industries.

Source: Medicoindustrien

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The 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 Danish medical devices are exported, and there is a substantial export surplus. A large share of Danish medical devices imports are incorporated into domestic production and subsequently re-exported as finished products.

The Danish Health and Medicines Authority under the Danish Ministry of Health is the national regulatory body for medical devices. The Authority’s principal function in this domain is to implement regulatory systems for the safety and performance of medical devices on the market. Information about rules and guidances on medical devices is available at http://medicaldevices.dk/

2.4: The eHealth industry

The Danish eHealth companies are growing, showing profits and are regarded internationally as holding huge potential for both further national growth and international exports. Out of the 92,000 employed in Danish private-sector ICT-companies, approximately 2,000 work for companies devoted mainly to eHealth, with annual turnover of an estimated EUR 0.5bn. A majority of these companies are organised under the Danish IT-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 Danish

companies abroad) Number of companies: 250 dedicated medical devices companies (total of 1,000 companies

in the industry) Number of employees: 20,000+ in Denmark (measured per capita, this gives Denmark one

of the largest medical devices industries in the world)

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Chapter 3: A strong healthcare system

In this chapter you can read about the framework conditions of the Danish healthcare system. The healthcare industry in Denmark is supported effectively by:

Five regions with responsibility for the public health service

New hospitals within a robust hospitals structure

Extensive digitisation

The health service in Denmark is operated largely by the country’s five regions, which have primary responsibility for the healthcare sector, including clinical psychiatry, doctors in private practice and specialists etc. In addition, the regions, jointly with the four faculties of health sciences, have executive responsibility 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-patient rehabilitation and preventive and health-promoting initiatives.

3.1: New hospitals and robust hospital services structure

Over the next decade, the five regions of Denmark will be implementing significant changes to the Danish hospital service. More than DKK 40bn is being invested in new hospitals and extensions to existing hospitals over the period 2010-2020. This corresponds to the renewal of just under one third of hospital square meterage in Denmark.

The hospital investments will modernise and future-proof the hospital service not least by consolidating emergency and specialised medical care within a smaller number of entities. To ensure the availability of modern healthcare nationwide and the ensuing quality boost as soon as possible, construction of the new buildings and extensions will commence over a period of a few years. A total of 16 hospital projects are planned. Investment in the new buildings is based on the requirement for flexibility regarding the financing of IT, devices and apparatus etc. This means that a billion-figure amount has been earmarked for the procurement and development of new devices and new technologies, which will be allocated on an ongoing basis over the next 10 years.

Concentrating specialist medical care and enhanced research facilities at the new hospitals will hold obvious opportunities for more wide-ranging collaboration with business and industry, including in research. The 2010-2020 hospital plan is illustrated in the figure.

Red circles = newbuilds on greenfield Blue circles = modernisation projects/extensions/expansions

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The 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. This will mean high patient volume per unit, consolidation of expertise and improved capacity for the continuity of medical care.

3.2: Extensive digitisation – electronic communication between health service partners The practice sector in Denmark consists of doctors in clinical practice, specialist doctors in clinical practice, physiotherapists, chiropractors, psychologists, dentists and dental assistants and chiropodists. General practice provides primary care to citizens and serves as the gateway to the rest of the health service as a resource 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. The prevalence of common IT standards means that much of the communication between health service partners – 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 electronically

Denmark has a tradition for thorough monitoring and registration of patients who are in contact with the health service. Extensive digitisation means that there are excellent opportunities for monitoring patients within the practice sector as well as the history of their disease over time. Within the next two years, all doctors will be required to gather and submit data on their patients regarding diabetes, COLD, cardiac insufficiency, ischaemic heart disease, stress, anxiety and depression in order that patients with these conditions may be monitored over time and across the country.

A number of international surveys also rank Denmark among the world leaders in healthcare IT. Among others, the Information Technology and Innovation Foundation, an independent IT think tank, rated Denmark, 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 available literature and data indicate that three countries—Denmark, Finland, and Sweden—are definitively ahead of the United States and most other countries in moving forward with their health IT systems. These three Nordic countries have nearly universal usage of electronic health records (EHRs) among primary care providers, high rates of adoption of EHRs in hospitals, widespread use of health IT applications, including the ability to order tests and prescribe medicine electronically, advanced telehealth programs, and portals that provide online access to health information. All three countries have embraced IT as the foundation for reforming 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 IT solutions even more seamlessly so that existing patient data can be accessed by different healthcare professionals and care staff, irrespective of where in the health service the data were originally entered. The vision is to achieve a single, cohesive health service in which IT and digital processes support continuity of care across hospitals, GPs, local authority domiciliary care services and so forth.

Denmark has notably won international acclaim for:

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Prevalence of the so-called Medcom standards that have digitised much of the communication within the health service. Prescriptions, referrals and discharge summaries are now on the whole transmitted electronically

Establishment of the health data network for secure electronic communication between all health service partners

The sundhed.dk web portal, where citizens have access to their own medical data from national health registers, hospital EHR systems, medication data and so forth. These data can also be accessed by the patient’s GP

Introducing the Shared Medical Card, which gives citizens and healthcare professionals access to a complete electronic record of each citizen’s current prescription medications. The Shared Medical Card system simplifies communication concerning medication between health service partners and helps to reduce the risk of mismedication. The Shared Medical Card system is expected to be rolled out in full at all hospitals and GP surgeries by the end of 2012

3.2.1: Electronic health records at Danish hospitals

Efforts have been in progress over the last few years to unify and consolidate a large number of hospital IT systems. The goal of achieving a single EHR system for each region is to be achieved by year-end 2013.

3.2.2: Telehealth

In recent years, the use of telehealth within the Danish health service has been stepped up as regards the use of telehealth in the diagnosis, treatment and monitoring of patients. Telehealth is typically organised as a cross-sectoral joint programme between the hospital, local authority and GP. Similarly, there has been wide uptake of interpreting services via videoconferencing to hospitals nationwide, and the aim is for remote interpreting 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 so that the full benefits of telehealth, especially in relation to chronic patients, may be realised. 2011 saw the launch 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 Integrated Home Monitoring – in Capital Region of Denmark and Central Denmark Region).

3.3.3: Unique registers, patient traceability and a culture of collaboration Denmark has a number of unique framework conditions tailored to facilitating high-quality research. The country 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 patients

In Denmark, every single citizen is identifiable by a unique national identity number; effectively a social security number. The personal number serves as a unique identifier for comparing and updating personal data across a large number of both public-sector and private-sector IT systems and registers. This facilitates research in, for example, making it possible to perform analyses across the different healthcare registers and databases.

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 in the national patient register and medication databases permit an outstanding degree of, e.g., patient-

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compliance monitoring. By linking the different registers, unique knowledge may be acquired on delivery of medical care across health service sectors. In addition, Danish research is strongly placed in bioinformatics and basic pathobiology

3.3.4: National registries

As of 1 March 2012, all data on the state of public health and data concerning health service activity, economics and quality will be consolidated at and analysed by Statens Serum Institut (SSI).

The registries will be utilised for national and local authority tasks and for research and analysis purposes in the field of health.

The registries comprise data on the nation’s health, morbidity and mortality, together with data on healthcare sector organisation and economics.

The national registries publish statistics on a regular basis, and offer access to data extraction. In addition, extracts from the registries are provided for activities such as analysis, research and planning.

3.3.5: The Danish clinical quality databases

The clinical quality databases contain crucial information on the national standards of healthcare in the public health service.

A clinical quality database is a registry containing selected measurable indicators which, based on individual disease courses, serve to shed light on either parts of or the overall performance standards within the health service and outcomes for a delimited category of patients. These databases are all restricted to a diagnostic group, a medical speciality or procedure. This means that separate databases 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 and potentials for improving quality of care.

There are currently 50 national clinical quality databases, which in combination cover approx. 60 categories of medical conditions.

The data completeness in the clinical quality databases is very high. With a requirement for completeness of at least 90 per cent, the databases are attractive both nationally and internationally. In addition, the databases 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 foreign hospitals 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 undergoing rehabilitation

National health insurance registry

Compulsory psychiatric admission

Human tissue utilisation registry

Registry of healthcare providers

Pharmaceutical statistics registry

Source: Statens Serum Institut (www.ssi.dk)

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3.3.6: Biobanks

Denmark has been a pioneer in establishing population-based biobanks. Several large biobank cohorts provide standardised information at enrolment and repeated follow-up of morbidity and mortality through linkage to the population-based health data registry systems.

Specific Danish resources such as our personal identification number, national healthcare system, registries defining 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 Denmark uniquely suited to a successful biobanking infrastructure. Several Danish biobanking initiatives have achieved international 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 information for research and healthcare. Comparison of genetic factors with lifestyle information and environmental impacts 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 access to various registries containing detailed patient data provide unique opportunities for epidemiological research and for advancing both basic health science research and clinical drug research. The fact that Denmark is a world leader in epidemiological research is to a great extent attributable to the nation’s many biobanks 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 industry

Ideas for new therapies and new products often come from doctors, nurses and other users of medical devices and technologies. Close, productive collaboration between healthcare professionals and the companies 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 a culture 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 makes for 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 and industry, which forms the basis for an effective healthcare industry. The research institutions develop collaborative projects and research platforms, while industry contributes market expertise and actual participation in development programmes. This collaborative culture co-exists in Denmark alongside the more formal frameworks for strategic partnerships between researchers and industry.

Denmark also distinguishes itself in offering a range of university degree programmes combining medicine with engineering studies in close partnership with industry. These programmes are offered at the University of Copenhagen/Technical University of Denmark, Aarhus University and Aalborg University. Another good example is the unique Danish Industrial PhD Programme run by the Danish Agency for Science, Technology and Information, and a sound formal system for research-industry collaboration contracts within the National Network for Technology Transfer – techtrans.dk.

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Collaboration examples from the regions

There is close collaboration between hospitals and universities on research, training and research appointments. This collaboration largely concerns combination appointments, research infrastructure and translational research. If a company contacts a clinical researcher with a view to conducting a trial at a hospital, 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, industry gains access to a network within the university setting. The regional structure of the Danish hospital sector ensures that, on making contact with the regions, industry not only has access to a hospital, but, in principle, 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 Southern Denmark has taken a firm stance on its mission to improve its capacity to form research partnerships with industry. The latest initiative is called “Southern Danish Health Innovation” (Syddansk Sundhedsinnovation). By concentrating regional initiatives within healthcare innovation, the Region is committed to achieving the best possible coherence and synergy between research, training, innovation and 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 strengthen clinical research in the healthcare sector. In December 2010, Capital Region of Denmark launched a new initiative, a ‘single-point-of-entry’ system (SPOE) for clinical trials, with the goal of further facilitating collaboration between hospitals and industry based on easier and more direct mutual access for industry and researchers.

The new SPOE system for clinical trials works as a gateway for industry to make contact with the right clinical centres for the purposes of setting up and conducting clinical trials within Capital Region of Denmark. The system offers to help the industry in early-stage feasibility mapping of clinical trials in Denmark and to identify candidate investigators for specific clinical trials. In addition, the SPOE system seeks to create research networks, clinical trial units and to foster closer collaboration between relevant partners in clinical research.

The high priority given to clinical trials is emphasised in the new Capital Region of Denmark health policy 2012. The SPOE system is also crucial in strengthening collaboration with other relevant clinical trial support-units within Capital Region of Denmark and in making the support structure more effective. Based on dialogue with industry and researchers the intention is to devise and launch further initiatives supporting and strengthening clinical trial collaboration during 2012 and 2013.

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Chapter 4: A strong tradition and sound framework conditions for clinical trials In this chapter you can read about the strong tradition and good framework conditions for conducting clinical trials 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 high international standard

Interested and suitable trial subjects – combined with sound registries and representative population statistics that make it possible to identify and trace the trial subjects

A well-organised hospital sector conforming to a high clinical standard o with administrative procedures aimed at collaboration with private-sector pharmaceutical

firms – and geared to international studies o with excellent research infrastructure geared to clinical research

Effective administrative processing by competent public authorities

High-quality Danish patient data

4.1: Clinical trials

This 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 place internationally in terms of the total number of clinical studies per country. If the number of clinical studies is measured 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 repeated FDA and EMA inspections of Danish trials have revealed no problems. The standard of quality is underpinned by the fact that Denmark has been one of the pioneer countries in the introduction of the principles of Good Clinical Practice, and the fact that the country currently has an effective network of competent GCP units attached to its university hospitals. Danish investigators and other clinical research staff consequently find it a given to abide by the GCP principles.

However, the quality of clinical research in Denmark has also been documented as being of a high standard. The volume of Danish scientific publications based on clinical trials is high (measured by per million capita) – and internationally Denmark is surpassed only by Sweden on this measure2.

Throughout the 1990s, a very large number of clinical trials were conducted in Denmark in, e.g., the cardiovascular area. Denmark has also subsequently demonstrated its strengths in connection with the

1 Kortlægning 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. 2 Dansk Sundhedsforskning – status og perspektiver (Danish Healthcare Research – Status and Perspectives), a report by

the Ministry of Health and Prevention, as represented by the executive forum for medical health research and the

Danish Agency for Science, Technology and Innovation, June 2008.

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performance of complex studies requiring extensive coordination and access to high-technology equipment such 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 the 10 diagnostic groups most frequently investigated under these clinical trials3:

Condition category Number of studies in 2010

Cardiovascular diseases 66

Cancer 55

Diabetes 38

Pain 32

Gastrointestinal diseases 25

Respiratory tract (lung and bronchial) diseases 15

Skin diseases 14

Viral diseases 14

Rheumatic diseases 14

CNS diseases 13

The Danish Health and Medicines Authority has made a similar listing focussing on clinical drug trials, see Annual Report 2011, Clinical trials in humans: http://laegemiddelstyrelsen.dk/~/media/E70DFD80B8A449C2A37806305CC1C802.ashx

With the prospect of significant improvement of the physical settings for the hospital service in Denmark over the next decade, during which more than DKK 40bn will be invested in new, specialised hospitals, the settings for clinical research in Denmark will also be greatly enhanced and align the national research infrastructure to meet future demands.

A significant strength for clinical research in Denmark is that approximately one third of each year of new graduates of medicine goes on to complete a PhD degree. A large number of such doctors conduct clinical research and, in so doing, gain qualifications which in the international context are outstanding. This means that within the Danish health service there are great many professionals who are capable of organising and conducting clinical research at the highest international level. 4.1.1: Danish patients are keen to participate in clinical research More than 100,000 Danes participate annually in clinical trials and medical research. Approximately 13 per cent of the adult Danish population has at one time or another participated at least once in medical research or a clinical trial4. Looking in k in isolation at clinical drug trials sponsored by private-sector pharmaceutical firms, figures from the Danish Association of the Pharmaceutical Industry (Lif) and Dansk Biotek5 indicate that approximately 20,000 citizens of Denmark participate in such trials every year. The majority participate in

3 The listing is based on data extracted from www.clinicaltrials.gov

4 Source: http://www.si-folkesundhed.dk/upload/medicinske_forsoeg_fkj.pdf

5 Industry association of Danish companies within biotechnology applied to drug development and industrial

biotechnology.

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clinical phase III trials6. The Danes are generally satisfied with the outcome of their participation in clinical trials 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 must be high, and in Denmark this is achieved by factors such as the tradition for explicit collaboration agreements between the Danish Association of the Pharmaceutical industry and the Danish Medical Association on Clinical Drug Trials.

Moreover, Danish legislation ensures assessment of such trials by an effective and confidence-instilling system of committees on health research ethics, and readily available insurance cover. Reviews of the Danish system of committees on health research ethics have reaffirmed the principle of having a lay majority serve among the committee members, and have served to streamline the processing of applications to conduct clinical trials so that it matches the requirements currently made of multinational clinical trials. The existence of a public-sector patient insurance system covering participation in clinical trials ensures that Danish trial subjects have easy and flexible access to insurance cover, if, contrary to expectations, they come to any harm as a result of trial participation.

In addition, Danish patients exhibit a high degree of trial compliance. In international terms, Danes have a high level of educational attainment – illiteracy being rare – and there is consequently great certainty that both oral and written information about the study will be understood as intended. An effective infrastructure and readily available health service to which patients are accustomed to seek medical care without demands for 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 may otherwise hinder participation in a clinical trial. 4.1.2. Single-point-of-entry for clinical trials in Denmark Denmark is already one of the countries with the most success in recruiting subjects for clinical trials. But equally, 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 Danish industry established a joint project to create a simple and efficient portal for concluding agreements on clinical trials for the whole of Denmark. This is achieved via a “single-point-of-entry” (SPOE) system that facilitates 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 unified health service, processes and contracts are standardised and recruitment is streamlined. The model ensures joint 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 for access to clinical trials with relevant patient groups. Companies that apply via the SPOE system in one region thereby automatically gain access to legal, medical and research expertise.

Within the SPOE system, companies can obtain recommendations regarding potential investigators for clinical trials in all parts of Denmark. The five regional entities are collaborating across regional borders and are therefore in a position to provide comprehensive feedback on potential Danish centres suitable for a proposed clinical trial.

6 Results from Lif’s and Dansk Biotek’s study of clinical research activities in Denmark in 2009, Lif and Dansk Biotek.

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What is single-point-of-entry for clinical trials?

Single-point-of-entry (SPOE) is a joint procedure for Danish health regions in alliances with industry (pharmaceutical and medical devices industry) on recruitment of trial subjects and formal 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 clinical trials at Danish hospitals

offers a comprehensive and nationally standardised service in the recruitment of patients, conclusion of agreements and delineation of roles and responsibilities among the parties to the agreement

is responsible for advising and informing applicants on the fastest and best approach to preparing to conduct clinical trials in Denmark

assists in the conclusion of agreements before the joint trial can be commenced

As a part of the SPOE system, the different clinical trial agreements will in future be processed more consistently. This will be achieved both by means of standardised agreements, including non-disclosure agreements, clinical trial agreements and sub-site agreements. Consistency is also safeguarded through a formalised 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 to develop improved registries for rare diseases. In addition, the regions will be launching R&D activities focusing on barriers to recruitment of trial subjects for clinical trials.

4.1.3. Quick processing of drug trial applications The Danish authorities assigned to approve clinical trials work swiftly and efficiently. Applications for approval of new trials must be processed within 60 days, but the Danish Health and Medicines Authority is aiming for processing to be completed within a maximum of 30 working days, corresponding to 42 calendar days. From April 2012 type A clinical drug trials will be processed within 14 working days. In 2011, 97% of all applicants were replied to within 30 working days. The remaining 3% were replied to at a delay of maximum 15 days. In 2010 just less than half of the applications had their trial approved. The remaining applications were turned down with a letter of justification, whereupon the final, and in most cases positive, decision was announced within 60 days. On a yearly basis, some 2 per cent of applications are rejected by the Danish Health and Medicines Authority.

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Applications to the Danish Health and Medicines Authority may be submitted electronically. The trials are registered in EudraCT, the European Community database of all clinical trials commencing in Europe from 2004 onwards, trial approval status vis-à-vis the national medicine regulatory authorities and health technology assessment bodies together with information on which countries and hospitals are participating. EudraCT is used for information exchange between the European medicine regulatory authorities. In addition, 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 system of committees on health research ethics, regional GCP bodies, the Danish Association of the Pharmaceutical Industry, the Danish Medical Association and the Organization of Danish Medical Societies (representing 117 societies) on clinical trials. The Danish Health and Medicines Authority holds regular briefings and dialogue sessions 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. the regional committee in the area where the principle investigator carries out the research project. The approval then covers all Danish sites. 4.1.4: Committees on health research ethics In order to safeguard the currency and efficiency of the Danish health research ethics committee system, the system was restructured as of 1 January 2012.

Under the new system, the decision-making process within the regional committees on health research ethics was simplified, and a new national committee was appointed with a number of special powers to ensure greater consistency within the committee system. The Act on Research Ethics Review of Health Research Projects entails electronic reporting and the possibility of ultimately coordinating the committee system’s reporting procedures with the Danish Health and Medicines Authority. In addition, English-language trial protocols no longer need to be translated into Danish. The Act allows for fast-track processing of project submissions against payment of a higher fee.

The new Act also allows for improved opportunities for conducting research in new situations – but naturally taking into account the subjects’' safety, rights and well-being. Research solely involving anonymous human biological material no longer requires the approval of the system of research ethics committees provided that the material has been collected in accordance with applicable rules.

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Chapter 5: World-class research In the healthcare area there is access to a strong research environment in Denmark. E.g. within pharmaceuticals, the medical foundation at both universities and hospitals is very solid. In this chapter you can read about the healthcare research at the Danish universities. This is followed by a description of a number of Danish research strengths and finally some of the new research initiatives in Denmark.

5.1: Health research at the Danish Universities 5.1.1: University of Copenhagen (KU) – Faculty of Health and Medical Sciences At KU health research is undertaken across the biomedical, natural and social sciences. Human and veterinary health and disease are addressed as one, from a ‘single-health’ perspective. Key areas include metabolic, neurological and mental health, healthy ageing, lifestyle diseases, cancer and communicable diseases including zoonoses. Basic and clinical disciplines within human and veterinary medicine are combined in translational and innovative research approaches, supported by a strong Danish platform based on stringent legal requirements and ethical standards in databases, biobanks and animal models combined with 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 drug development. 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 well as biotechnology, food and veterinary related research. The research has a strong focus on technical disciplines and technological development and spans disciplines such as electromechanics, imaging, robotics, nanotechnology and informatics through drug delivery, bioinformatics, nutrition and health to organisational planning of healthcare services, construction and facility management and ambient assistive living technologies. DTU has a strong tradition for industry collaboration and access to state-of-the-art labs and facilities, e.g. a centre for micro- and nanofabrication with clean room facilities and a centre for electron microscopy. For more information about research and facilities at DTU, see: www.dtu.dk 5.1.3: University of Southern Denmark (SDU) - Faculty of Health Sciences The 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 health promotion, prevention, rehabilitation, and methods of examination and treatment. The Faculty of Health Sciences 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

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5.1.4: Aarhus University (AU) - Faculty of Health Sciences The Faculty of Health Sciences (Health) at AU consists of five strong departments and houses research activities from basic science to applied clinical research and even epidemiological research within a wide range of areas. A hallmark of Health is its close cooperation with Aarhus University Hospital where medical research on a large scale is taking place literally among the patients for the benefit of both patients and the academic disciplines. Knowledge exchange is a core activity at Health and comprises knowledge sharing and cooperation 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 Medicine The Faculty of Medicine at AAU is working to create better health, welfare, and growth in close cooperation with society at large. The Faculty combines basic research and innovation in the fields of health science and technology. The research areas range from cell to system, e.g. biomedical technology, medicine, sensory systems, pain, translational research, drug testing (clinical trials), neural prostheses, rehabilitation, telehomecare, sports science, biomedicine, and medical informatics. In 2013, the Faculty will be establishing a department of clinical science, which will be a part of Aalborg University Hospital. The Faculty houses a number of highly advanced laboratories and research facilities fulfilling international standards and specifications. AAU has a long and strong tradition for collaborating with industry partners. For more information, see: http://www.hst.aau.dk/ and http://www.medicine.aau.dk/

5.2: Positions of strength in Danish research 5.2.1: Lifestyle Danish registries are well suited to investigating epidemiological correlations in obesity research and to formulating hypotheses on the development and treatment of obesity. Several European alliances have been established 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 the University of Copenhagen within Food, Fitness and Pharma is an example of a multidisciplinary approach involving more than 200 researchers. Denmark has some of the best-characterised population studies internationally with biological material and genetic research focusing on disease etiology and biological markers. 5.2.2: Diabetes mellitus Diabetes is a chronic disease that presents a major and growing health problem globally. Denmark has a strong tradition in both type 1 and type 2 diabetes research, from epidemiology, pathogenesis and genetics to treatment of diabetes and its complications. Danish registries and data from the Scandinavian homogeneous populations have been important tools in translating diabetes research into treatment options covering all phases of diabetes. Also, Denmark has a tradition for public-private partnerships and via Novo Nordisk has contributed considerably to diabetes research and advances in diabetes therapy worldwide. 5.2.3: Neuropsychiatry Neuropsychiatric disorders constitute a major disease and financial burden worldwide and improved treatments based on the latest insights into disease mechanisms will be of pivotal importance. The universities and university hospitals in Aarhus and Copenhagen have strong research environments within psychiatric genetics and preclinical as well as clinical neuropsychiatry. Furthermore, these centres

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collaborate closely with Danish pharmaceutical companies such as Lundbeck A/S and Neurosearch on basic preclinical research as well as drug development targeting the neuropsychiatric area. The outcome of translational research in neuropsychiatry in Denmark is promising; some examples are given here. 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 and psychopathological measurements have provided new insight into and identified biomarkers of diseases such as depression, obsessive-compulsive disorders and schizophrenia, while preclinical studies have elucidated some of the brain mechanisms involved in drug addiction. 5.2.4: Cancer research Cancer 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 is concerned, Denmark has a very strong cancer registry (actually the oldest in the world) existing for more than 50 years. With cancer treatment taking place almost exclusively within the public hospital system it is possible to track both the general population and individual patients to study their exposure to environmental factors, and most importantly the relationship between genotype and environment – termed molecular epidemiology. Denmark also has several strong groups in biomarker discovery together with comprehensive biobanks (from 2008 a national cancer biobank programme for all branches of oncology) that are essential for biomarker validation. Denmark has a solid tradition for clinical cancer research with established research units at all university hospital oncology departments. The research is conducted across medical specialties and has strong international impact.

5.3: Recent major investments in the research infrastructure Denmark is currently investing heavily in a new research infrastructure that will provide unique settings for conducting research at the highest international level. 5.3.1: DanStem The Danish Stem Cell Center (DanStem), opened in the summer of 2011, is currently establishing itself as a hub for international basic, translational and early clinical stem cell research. The aim of DanStem is to develop 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 formation of beta cells and the special properties of cancer stem cells. This section is funded by The Novo Nordisk Foundation. TransStem will translate promising basic research results into new strategies and targets for the development of new therapies for cancer and diabetes and move these fields towards early clinical application. This section is funded by a grant from the Danish Council for Strategic Research. Together, the sections will give researchers at DanStem the opportunity to perform cutting-edge basic stem cell research and translate this into novel therapies for two very major global diseases – diabetes and cancer. For more information, see: http://danstem.ku.dk/

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5.3.2: The Danish National Biobank Denmark is at the very frontier of epidemiological research. This is to a large extent due to the unique Danish registries which provide detailed information on the entire population. With the establishment of a major national biobank and the possibility of linkage between biological specimens and information contained in the 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 the Ministry of Science, Technology and Higher Education to establish a national biobank. The goal is to strengthen the Danish research infrastructure and thereby the conditions for Danish public health research and international research collaborations. The Danish National Biobank opened in March 2012 and is one of the world's largest biobanks and internationally an absolutely unique resource for the benefit of research in the 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 specimens made available by the Danish health services and the largest research biobanks, including specimens at SSI.

A large biobank at SSI: a large national biobank based on the specimens submitted to Statens Serum Institut (SSI), the national institute for prevention and control of infectious diseases and congenital disorders. The material currently includes more than 6 million specimens. In addition to specimen reception, storage and dispensing, the biobank will undertake developmental projects to enhance the capability for extracting valuable information from biological material.

A coordinating centre: to coordinate compilation of the biobank register and the new national biobank with subsequent responsibility for the daily management of the activities. The centre will also 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 specimens collected by the public health sector. Researchers will benefit from a unique overview of and access to more than 15 million biological specimens in existing as well as future collections. Projects approved by the national system of committees on health research ethics and the Danish Data Protection Agency will obtain permission to link biological material from one individual with the vast amount of further information available in the national registers within public health for example. The Danish National Biobank is a joint initiative between Statens Serum Institut, hospitals, universities and other public research institutions collecting or using biological material. For more information, see: http://www.ssi.dk 5.3.3: Other investments in research infrastructure In addition, Denmark is making a large number of other research infrastructure investments. Examples include: 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 Cell Center and The Novo Nordisk Foundation Center for Basic Metabolic Research, all at the University of Copenhagen; 4) New hospital buildings worth more than DKK 40bn which will renew just under a third of the Danish hospital square meterage by 2020. The establishment of the multidisciplinary Danish Platform for Large-scale Sequencing and Bioinformatics coordinated from COBIS in Copenhagen is another example of a unique research initiative that is currently attracting international research investments.

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Chapter 6: Denmark a great place to do business

In this chapter, you can read more about doing business in Denmark. With a corporate tax rate of 25 per cent, competitive business costs and some of the world’s most flexible labour market conditions, Denmark is an attractive choice for foreign investors. Add to this a very simple procedure for establishing a business and the presence of a highly skilled and motivated workforce. The result: some of the best possible conditions for doing 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 researchers

6.1.1: Europe’s most flexible labour market According to the IMD World Competitiveness Report 2011, Denmark offers the highest labour market flexibility in Europe and is ranked 1st in the world. Scaling a business up or down can be implemented more smoothly in Denmark than anywhere else in Europe.

Source: IMD World Competitiveness Yearbook 2012

Compared to other European countries, the Danish rules for termination of contracts are very liberal. The employer is entitled to dismiss skilled and unskilled workers at any time, without incurring costs, making it easier 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 work hour rules are negotiated between labour market organisations or directly in the company to best address market conditions and business needs. In Denmark most people are insured against unemployment and

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thereby guaranteed a high level of social security, which results in a relatively high degree of labour market flexibility. 6.1.2: Highly skilled, well-educated population

Denmark is highly aware of the importance of education and a tradition for life-long education at every level of employment. The availability of skills is vital for a well-functioning labour market. The Danish Government and 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 and private institutions offer high quality at low costs. As a result, Denmark has a well-educated population with a high proportion of university graduates. The percentage of the population that has attained at least upper secondary 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 and internationally oriented. There is no problem finding multilingual staff in Denmark since 80% of the workforce speaks English. According to the IMD World Competitiveness Report 2011, Denmark is placed 2nd in the world among non-English speaking countries, on English proficiency. 6.1.3: Business culture & work habits Companies with relatively flat organisational structures are very common in Denmark, which results in higher responsibility for individual employees. In general, the Danish workforce is perceived as highly motivated by foreign 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 either independently or in project-oriented teams. A strong sense of responsibility in turn leads to increased productivity and higher earnings. A high level of education combined with independence and flexibility makes the Danish workforce capable of taking on tasks, which in other countries would be the preserve of university-trained specialists. Such skills are of crucial importance to companies in today’s business world. 6.1.4: Easy to establish a business Denmark is among the world’s best locations for doing business. Forbes has ranked Denmark in top 5 worldwide for the fourth straight year (Forbes Best Countries for Business 2011), and the World Bank’s “Ease of doing business Report” ranks Denmark 1st in Europe and 5th in the world (Economy Rankings 2012). Denmark offers foreign investors a wide range of possibilities for establishing a business, enabling them to tailor their investment plans to suit their business needs. Incorporation of a company is simple and can be done online from one day to the next. 6.1.5: Effective infrastructure Denmark has an effective and well-developed infrastructure, allowing companies to operate easily by air, sea and land. From Copenhagen and the surrounding Øresund Region you are within 5-hour access of more than 46 million people giving you an immediate advantage compared to e.g. the corresponding 18 million people accessible from Stockholm. Denmark also has world-class IT infrastructure with some of the world’s highest ICT penetration rates for mobile, broadband and PC.

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6.1.6: Denmark is a safe place to live A characteristic feature of the Danish working and family life is quality – Denmark is a safe and secure society with free public health and educational services and a clean environment. This is why Denmark is ranked second on quality of life in the annual Monocle quality of life survey (Monocle 2010). 6.1.7: Low level of corruption Denmark is by all accounts one of the least corrupt countries in the world. According to the annual Transparency International index of perceived national corruption Denmark does well in ratings of corruption and anti-corruption efforts. According to the IMD World Competitiveness Report 2011, Denmark also occupies a first place in the list of least corrupt countries in the world.

Source: IMD World Competitiveness Yearbook 2012

6.1.8: Easy access to researchers One big advantage of a small country like Denmark is that networking is easier, with less separation between the 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 clinical applications. 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 fostered by the educational institutions, where the aim is to teach students to work together in an interdisciplinary context, resulting in efficient teamwork and innovative research and products. For more information on establishing a business in Denmark, see: http://www.investindk.com/

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6.2: Human resources within the pharmaceutical industry Denmark has a large pool of human resources with high-level expertise and advanced qualifications within a wide range of pharma, biotech, medtech and other healthcare industries. Within the pharmaceutical industry, the employees of Danish pharmaceutical firms are characterised by their high level of educational attainment. Around 25 per cent of the some 20,000 employees have a long-cycle tertiary 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 which facilitates international recruitment. Looking at clinical research in isolation, in 2010, just under 1,500 individuals had jobs in clinical research at Danish 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 pharmaceutical industry.

37 per cent of all Danish pharmacists, 32 per cent of all human biologists, 21 per cent of biochemists and 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 are proactive in meeting demand for pharmaceutical experts. Within the last decade, total intake on PhD programmes doubled from 1,289 PhD enrolments in 2003 to 2,480 new enrolments in 2010 – the majority of the new PhD enrolments being in the disciplines of natural science, technology and health science. Similarly, the number of pharmacists is expected to increase by just over 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 Danish universities increasingly offer masters-equivalent programmes geared specifically to employment in the pharmaceutical industry. The latest pharma-oriented degree programmes include: Molecular Biomedicine, Nanobioscience, Biomedicine, Biotechnology, Bioinformatics, Pharmaceutical Chemistry and Pharmaceutical Science.

7 Kortlægning af dansk lægemiddelforskning – Delnotat IV – Rammebetingelser, i form af højtuddannede kandidater og

ph.d.er inden for lægemiddelforskning (Mapping of Danish pharmaceutical research, sub-report IV, framework

conditions; highly-qualified MSc-level graduates and PhD holders in pharmaceutical research), Danish Agency for

Science, Technology and Innovation, October 2010.

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Chapter 7: Financing sources

Denmark has a range of financing sources, ranging from state incentive programmes and private investors to banks, venture capitalists and institutional investors. In this chapter you can read about the vast funding and financial potentials open to your company in Denmark.

7.1: Denmark and free trade As Denmark supports free trade and welcomes foreign investors, companies enjoy a number of advantages when setting up in business in Denmark. In addition, Denmark offers excellent opportunities for public-sector funding for establishing public-private research partnerships such as via The Danish National Advanced Technology 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 incentives available

Denmark complies with the European Union directives on free and fair competition within the EU

Comprehensive R&D funding Companies 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 sector

Name of fund Focus area Partner Requirements

For more information

The Danish Council for Strategic Research: Programme Commission on Health, Food and Welfare

Funding for projects in biological manufacturing, connection between food, health, lifestyle and drug resistance as well as health initiatives to counter external influences. Emphasis will be placed on high relevancy as well as on effects and benefits. There will also be emphasis on the research being conducted as an integrated interaction between public and private sector research as well as on co-financing.

Danish Agency for Science, Technology and Innovation

http://en.fi.dk/funding

The Danish Council for Independent Research: Medical Sciences

Funds specific research activities covering all aspects of basic, clinical and socio-medical research geared towards human health and disease.

Danish Agency for Science, Technology and Innovation

http://en.fi.dk/funding

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The Danish

Council for

Independent

Research:

Natural

Sciences

Funding for projects geared towards basic

scientific issues within natural sciences,

computer science and mathematics.

Danish Agency for

Science,

Technology and

Innovation

http://en.fi.dk/fu

nding

The Danish

Council for

Strategic

Research:

Programme

Commission

on

Individuals,

Disease and

Society

Funding of strategic research with the

objective of finding solutions to

significant challenges in the field of health

and thereby guaranteeing a high standard

of treatment and disease prevention as

well as optimizing the organisation of

health service. Emphasis will be placed on

high relevancy as well as on effects and

benefits. There will also be emphasis on

the research being conducted as an

integrated interaction between public

and private sector research as well as on

co-financing.

Danish Agency for

Science,

Technology and

Innovation

http://en.fi.dk/fu

nding

The Danish

Council for

Strategic

Research:

Programme

Commission

on Strategic

Growth

Technologies

Funding for projects devoted to interdisciplinary applications of nanotechnology, biotechnology and information and communication technology, including intelligent solutions for society.

Danish Agency for

Science,

Technology and

Innovation

http://en.fi.dk/fu

nding

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Innovation

Consortia

Innovation consortia are collaboration projects between companies, research institutions and advisory/knowledge dissemination parties. The purpose of the consortia is for the parties to jointly tdevelop knowledge or technologies that benefit not only individual companies but entire industries within the Danish business community.

An innovation

consortium

should consist

of at least two

companies, a

research

institution and

advisory/know

ledge

dissemination

party.

Collaboration

should be

agreed for a

duration of

between two

and four

years.

Danish Agency for

Science,

Technology and

Innovation

http://en.fi.dk/fu

nding

Industrial PhD

Programme

An Industrial PhD project is a three-year project where the student is hired by a company and enrolled at a university at the same time.

The company

receives a

monthly wage

subsidy of DKK

14,500 while

the university

has its

expenses for

supervising

etc. covered.

Danish Agency for

Science,

Technology and

Innovation

http://en.fi.dk/fu

nding

The Danish

National

Advanced

Technology

Foundation

The Danish National Advanced

Technology Foundation offers private

companies and universities the funds and

the framework for developing new and

important technologies.

The Danish

National

Advanced

Technology

Foundation

http://hoejteknol

ogifonden.dk/en/

Industrial

postdoctoral

programme

under The

The aim of the Industrial postdoctoral

programme is to strengthen cooperation

and exchange of technology between

companies and public-sector research

Co-funding -

1-2-3 model

The Danish

National

Advanced

Technology

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Danish

National

Advanced

Technology

Foundation

institutions and to strengthen

researchers’ ability to work in different

environments across different cultures.

The researcher’s time is split between the

company and the research institution.

The programme is aimed at small and

medium-sized enterprises (SMEs) as well

as large companies seeking to collaborate

with public-sector research institutions.

The scheme covers all areas of advanced

technology. The basic set-up is that one

individual can apply for an industrial

postdoctoral project of 1-3 years’

duration. The financing of the project is

arranged by the parties through the

Foundation’s 1-2-3 model, based on the

principle that all parties contribute with

their own share of co-funding. In addition

to this, the company and the research

institution each provide a mentor, who

acts as a sparring-partner for the

industrial postdoctoral researcher.

Foundation

http://hoejteknol

ogifonden.dk/en/

The Public

Welfare

Technology

Fund

The Public Welfare Technology Fund is a government initiative, administered by the Danish Agency for Digitisation – an agency under the Danish Ministry of Finance. The purpose of the fund is to invest in projects that utilise new and innovative technological solutions to increase productivity and efficiency in the public sector.

The Danish

Agency for

Digitisation

http://www.abt

fonden.dk

26% gross

income tax

scheme

26% gross income tax scheme for certain

researchers and other key employees for

up to 5 years.

The Danish Tax

Agency

www.skat.dk

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7.3: Aid schemes for seed capital and research financing Denmark offers various financing opportunities for pharmaceutical, biotechnological, medical technology and

eHealth companies. Some of the biggest players on the Danish venture capital market are Sunstone Capital,

SEED Capital, and the state-owned Vækstfonden.

Denmark also has a number of incubators who administer pre-seed capital through a programme initiated by

the Ministry of Science and Higher Education. The incubators have difference focus areas and are placed in

innovative environments close to the universities. The incubators also offer housing for high-tech companies,

with access to superior research capabilities and facilities, strategic networking and reductions in time-

consuming administrative costs. The incubators are fundamental in the Danish innovation system as an

infrastructural framework for high-tech and knowledge-based entrepreneurship- and growth-companies.

Denmark offers a wide range of locations for life science companies, all of which can be custom-designed to

suit the needs of the companies. Below the various incubators are presented on the Danish map.

Scion DTU

Scion DTU

Symbion Science ParkCOBIS

CAT Sciences Park

Science Park of Southern Denmark

Science Park of Southern Denmark

Novi Science Park NanoLab Nord

Incuba Science ParkIncuba Sciences Park Skejby

Sciences Center Skejby iNANO House

Life Sciences

Locations

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The Authors This report is based on input and data from the below partners:

Ministry of Health

The Ministry of Health is in charge of the administrative functions in relation to the organisation and financing of the healthcare system, psychiatry and health insurance as well as the approval of pharmaceuticals, and the pharmacy sector.

Ministry of Foreign Affairs of Denmark - Invest in Denmark

As part of the Ministry of Foreign Affairs of Denmark, Invest in Denmark is a tailored one-stop service for foreign companies looking to set up business or research activities in Denmark.

Ministry of Business and Growth

The Ministry of Business and Growth seeks to improve the conditions for growth in Denmark. The Ministry conducts thorough economic analyses and suggests policy initiatives in areas imperative to economic growth.

Danish Regions

Danish Regions is the interest organisation for the five regions in Denmark. Their overall mission is to safeguard the interests of the regions nationally as well as internationally.

Danish Association of the Pharmaceutical Industry (Lif)

Lif's mission is to work to ensure that the pharmaceutical industry has the best possible conditions to research, develop, market, distribute and provide information on medicinal products so as to ensure that patients have extensive, fast access and rapid access to the best medical treatment.

Medicoindustrien

Medicoindustrien is the industry association for companies in Denmark which develop, manufacture, sell or otherwise take an interest in medical devices.

Medicon Valley Alliance

Medicon Valley Alliance is a network organisation working for the life science organisations in Medicon Valley. As a non-profit member organisation the Alliance implements initiatives on behalf of the life science community with the goal of creating new research and business opportunities within the region.

The Danish IT Industry Association (ITB)

With approximately 400 IT-member companies The Danish IT Industry Association (ITB) is the largest and leading independent representative for the IT-business community in Denmark.

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Contributing partners