Sweden’s national life sciences strategy Prodution: Ministry of Enterprise and Innovation Cover photo: Ole Berg-Rusten NTB Scanpix/TT Nyhetsbyrå Inside cover: AstraZeneca Article no: N2020.03 2Print: Sweden’s Elanders national life sciences strategy Foreword
Sweden is a knowledge nation that has long invested in equitable health care, research and innovation. This has benefited our economic prosperity, advanced our health care system and improved the health of our population.
Sweden aims to be a leading life sciences nation. To tackle the challenges facing Sweden’s welfare, there must be greater focus on preventing ill health and disease. We need to rapidly introduce new working practices, technologies and treatments to improve the effectiveness and quality of health and social care. We can achieve this through world-leading research and innovation, favourable conditions for industry and an ecosystem of collaboration that attracts investment.
Sweden has the necessary prerequisites: world-class research and research infrastructure, a health care system of high international standard, competitive industry and world-leading innovation. The Government is firmly committed to continuing to develop these areas of strength. We want Sweden to lead the international transition to precision medicine; it is under way and the life sciences sector plays a major role in it. Ultimately, it is a matter of improving health for women and men, girls and boys, improving patient empowerment and self-management of care and treatment, and empowering care recipients and increasing their confidence.
Today’s health care is yesterday’s research, and today’s research is tomorrow’s standard health care treatments. The pace of change is accelerating; major medical breakthroughs have taken place in recent years. Several types of cancer that we were previously powerless in the face of can now be cured or treated. Advances in assistive technologies offer completely new opportunities to improve the quality and effectiveness of care services. This can make daily life easier for both care recipients and staff. Similarly, the application of
Sweden’s national life sciences strategy 3 artificial intelligence creates new opportunities for using data and digital solutions in intelligent decision support systems and diagnostics. The changes taking place also call for skills development and create the need for new health professions, such as those that combine technological and medical expertise. Attracting top talent will be vital to ensure success.
Sweden’s strength is collaboration between industry, academia and the public sector; through collaboration we can build a stronger society. Together with the entire life sciences sector, we will lay the foundation for continued progress – to improve the health of the population, develop our health care system and strengthen Sweden’s economic prosperity.
Ibrahim Baylan Minister for Enterprise and Innovation
Matilda Ernkrans Minister for Higher Education and Research
Lena Hallengren Minister for Health and Social Affairs
4 Sweden’s national life sciences strategy Contents
Sweden’s national life sciences strategy 6 The role of life sciences in addressing health challenges and strengthening competitiveness 6 Priority areas 11 1. Structures for collaboration 12 1.1 Strengthened national coordination in life sciences 13 1.2 Partnerships for regional and national mobilisation 13 1.3 Nordic region – a world-leading life sciences hub 13 2. Unlocking the potential of health data for use in research and innovation 14 2.1 Effective and secure sharing of patient data 17 2.2 Increased use of health data in research and innovation 17 2.3 Effective, secure and ethical use of register data 17 2.4 Better use of biobanks 17 2.5 Follow-up using real-world data 17 3. Responsible, secure and ethical policy development 18 3.1 Efficient process for implementing new therapies 21 3.2 Accelerated, secure and ethical policy development 21 3.3 Implementing new medical device regulations 21 3.4 Greater focus on preventive interventions and self-management 21 4. Integration of research and innovation into care delivery 22 4.1 Incentives and good opportunities to combine clinical practice and research 25 4.2 More industry-initiated clinical studies in Swedish health care 25 4.3 High-quality clinical studies 25 4.4 Pioneering the introduction of precision medicine in care services 25 5. Assistive technologies for increased independence, participation and health 26 5.1 Harnessing the potential of assistive technologies 29 5.2 Development and collaboration for implementation 29 6. Research and infrastructure 30 6.1 Strengthened cross-sectoral life sciences research 33 6.2 Excellent life sciences research infrastructure 33 6.3 Increased and broader use of research infrastructure 33 6.4 Strengthened infrastructures for data-driven research and innovation 33 6.5 Increased Swedish participation in EU programmes 33 7. Skills supply, talent attraction and lifelong learning 34 7.1 Good opportunities for lifelong learning 35 7.2 Effective collaboration to ensure skills supply 35 7.3 Offering competitive conditions to recruit internationally 35 8. International attractiveness and competitiveness 36 8.1 Better business environment for research and development 37 8.2 Increased export and investment promotion 37 8.3 World-class business incubators 37 8.4 Continuous monitoring, analysis and follow-up 37
Sweden’s national life sciences strategy 5 Sweden’s national life sciences strategy
Sweden aims to be a must be harnessed in the change engagement to strengthen life leading life sciences process – but without burdening sciences already present in society. them or similar groups with The strategy builds on the policy nation. Life sciences responsibility for development at direction previously adopted by contribute to improving national level. the Government. In the strategy, health and quality of life of the Government outlines objec- To strengthen the life sciences tives in priority areas in which the population, ensuring sector in Sweden, the Govern- change is considered particu- economic prosperity, ment has established a life sci- larly important. The strategy and advancing the country ences coordination function1 – its objectives are based on the as a leading knowledge the Life Sciences Office – to serve current financial framework. as a link between life sciences sector nation and achieving the stakeholders and the Government’s The role of life sciences in 2030 Agenda for Sustain- work. The Office aims to promote addressing health challenges able Development. knowledge development, inno- and strengthening competi- vation and quality – in health tiveness This national strategy aims to and social care and at universi- The pace of innovation is high in strengthen the long-term com- ties and higher education institu- the life sciences sector. Data-driven petitiveness of Sweden as a life tions – and improve conditions innovative solutions and scientific sciences nation. The Govern- for the establishment and opera- advances will have a fundamental ment’s life sciences strategy is tion of life sciences companies in impact on developments in pre- intended for stakeholders with Sweden. The aim of the strategy is vention, diagnostics, treatment, a mandate and ability to change to support the initiatives and monitoring, habilitation and conditions for life sciences in Sweden. Sector stakeholders pri- marily include universities and higher education institutions, What is the life sciences sector? government agencies, authorities responsible for health and social The life sciences sector includes companies, higher education care services, companies operat- institutions, and public stakeholders at municipal, regional and state level whose activities contribute to promoting human ing in the life sciences area and health. The sector comprises research, higher education public and private financiers of and innovation, the development of pharmaceuticals, medical research and innovation. Patients, devices and treatments, as well as prevention, implementation care recipients, and health and soc- and monitoring. ial care staff are key in this context, and their experience and expertise
1 N2018/00814/IFK Establishing a life sciences coordination function at the Government Offices (in Swedish).
6 Sweden’s national life sciences strategy Strong life sciences clusters in Sweden More than 42 000 employees in almost 3 000 companies
Sweden’s life sciences industry Umeå Net exports
45 45
40 40
35 35
30 30
25 25
20 20
15 15
10 10
5 5
0 0
-5 -5
-10 -10 20102010 20112011 20122012 20132013 20142014 20152015 20162016 20172017 20182018 Stockholm Nettoexport,Net export,Nettoexport, LifeLife sciences ScienceLife Science PharmaceuticalsLäkemedelLäkemedel MedicinteknikMedicinteknikMedical technology Uppsala Sweden’s trade in pharmaceuticals and medicalSverigesSveriges handeltechnology handelmed läkemed med läkemed och och Gothenburg Linköping medicinteknikmedicinteknik 90 90 80 80 70 70 60 60 50 50 40 40 30 30 20 20 10 10 0 0 2010 20112010 20122011 20132012 20142013 20152014 20162015 20172016 20182017 2018
Pharmaceuticals,Läkemedel,Läkemedel, import imports import Medicinteknik,Medicinteknik,Medical Import technology, Import imports Malmö-Lund Pharmaceuticals,Läkemedel,Läkemedel, Export exports ExportMedicinteknik,Medicinteknik,Medical Export technology, Export exports
Region Skåne, which includes Malmö-Lund, is part Sweden’s foreign trade in pharmaceuticals of Medicon Valley, the bi-national cluster of the and medical technology in SEK billions. In Öresund region of Skåne-Copenhagen. 2018, exports of pharmaceuticals accounted for 5.7 per cent, and medical technology 1 per cent, of Sweden’s total exports.
Source: Growth in Sweden’s life science industry 2014–16, Swedish Agency for Growth Policy Analysis, 2018
Sweden’s national life sciences strategy 7 rehabilitation. Sweden’s capacity to continue to invest in research and must take place in close harness these new opportunities innovation, based in part on the collaboration with industry, rele- will have consequences for costs to principle of universal design. Tech- vant government agencies, society, health outcomes and com- nological and scientific advances universities and higher educa- petitiveness. Making such advances must be promoted and applied. tion institutions. It is vital for the available should be facilitated. At OECD data2 shows that relevant health and quality of life of the the same time, all measures countries in 2017 invested on aver- population that conditions are in the area must be implemented age only 2.8 per cent of their total favourable for implementing new ethically, ensuring information health care expenditure in prevent- technologies in the health care security and privacy protection, as ing illness and disease (3.3 per cent system. Whole-genome sequenc- well as data protection and secrecy. in Sweden). Sweden – and the ing diagnostics is already being rest of the world – must change used today to identify the optimal Sweden is facing major health chal- approach and invest more in health treatment of certain cancers, lenges at regional, national and promotion and prevention of both reducing the significance of the global level. Health inequalities lifestyle and other diseases. location of the tumour in the across socio-economic groups are Greater knowledge is needed about body. Instead, the focus is on the increasing, the incidence of over- how ill health can be prevented, at type of cancer cells causing the weight, obesity and high blood both individual and system level, disease. Other patient groups that pressure is rising and conditions to identify the most effective particularly benefit from genetic indicative of mental ill health are measures. Shifting to early diag- diagnostics include those with becoming increasingly common. nostics for children and adults also rare hereditary diseases. The cause Disability and gender also have a increases the chances of preventing of around 250 such diseases are bearing on health. The effects of or mitigating disease. identified every year, and each socio-economic factors, disability new diagnosis may represent the and gender are also mutually Health care is currently being launch point for developing targeted, reinforcing. Demographics are transformed through increased potentially curing, therapies. changing and the proportion of opportunities for personalised older people is increasing. This re- care – or ‘precision medicine’. Parallel with developments sults in a greater need for health This transformation is challeng- towards precision medicine, a and social care interventions. ing existing working practices, structural change is under way in Modern health care is further chal- priorities and structures, and the Swedish health care system. It lenged by growing antimicrobial creating new needs. Sweden must is aimed at developing a modern, resistance and global pandemics. now ensure that all parts of the equitable, accessible and effective health care system have the health care service focusing on To address these health challenges prerequisites to enable this system primary care, and ensuring that in the long term, Sweden needs to transformation to continue. This care interventions in highly spe- cialised care are allocated at the optimal level (‘level structuring’), both regionally and nationally.3,4 What is precision medicine? With the support of the Swedish Precision medicine refers to diagnostic methods and therapies Association of Local Authorities for personalised screening, prevention and treatment of and Regions, the regions are also disease, applied at individual level or to specific segments of the establishing a common health care population. The new opportunities offered by precision medicine knowledge management system. are based on recent advances in e.g. molecular biosciences (the ‘omic’ technologies) and bioinformatics, and the emergence Long-term development efforts to of new high-resolution imaging technologies. improve health include social, eco- nomic and ecological sustainability. The incentive for a rapid climate- smart transition is strong, because 2OECD Health Statistics 2019 and own calculations. this transition is a prerequisite for 3ToR 2017:24 Coordinated development of a modern, equitable, accessible and effective health care service, our health and wellbeing in the long focusing on primary care (in Swedish). term. The 2030 Agenda must 4S2017/00506/FS Assignment to develop a procedure for level structuring of highly specialised care (in Swedish). therefore serve as a guide.
8 Sweden’s national life sciences strategy Illustration: AstraZeneca
Sweden is a successful research concrete initiatives will be regu- 4. Integration of research and and innovation nation. The life larly linked to this strategy. The innovation into care delivery sciences industry is one of our strategy is based on input from 5. Assistive technologies for basic industries, but international sector stakeholders, such as higher increased independence, competition is intensifying. education institutions, participation and health Several comparable countries have government agencies, interest 6. Research and infrastructure made substantial investments in organisations and companies, 7. Skills supply, talent attraction, life sciences. including the life sciences partner- and lifelong learning ship group. The Government has 8. International attractiveness To harness the potential in the identified eight priority areas in and competitiveness sector, a strategic and integrated which change is considered approach, with clear objectives, particularly important: is required. Broad collaboration, with clarity regarding responsibili- 1. Structures for collaboration ties, is needed to reach consensus 2. Unlocking the potential of on which measures will be health data for use in research necessary from each stakeholder. and innovation 3. Responsible, secure and As a long-term framework, ethical policy development
Sweden’s national life sciences strategy 9 Photo: Johan Strindberg Bildhuset/TT Nyhetsbyrå
10 Sweden’s national life sciences strategy Eight priority areas and 30 objectives
1. Structures for collaboration
2. Unlocking the potential of health data for use in research and innovation
3. Responsible, secure and ethical policy development
4. Integration of research and innovation into care delivery
5. Assistive technologies for increased independence, participation and health
6. Research and infrastructure
7. Skills supply, talent attraction and lifelong learning
8. International attractiveness and competitiveness
Sweden’s national life sciences strategy 11 1. Structures for collaboration
Broad collaboration is essential regional areas of strength and Council of areas in which the to enable Sweden to be a globally specialisation need to be encour- responsible authorities need competitive life sciences nation. aged to act as engines to boost knowledge. The transition to precision Sweden’s life sciences internation- medicine in health and social care ally. Regional life sciences strate- The Government has launched will require engagement from all gies, produced by the regions four innovation partnership stakeholders in the sector. System themselves, are important for programmes for the electoral innovation is key to harnessing developing Sweden’s strengths, period 2019–2022, one of which new digital opportunities and while also needing to be synchro- is in health and life sciences. data use that will enable the nised with initiatives conducted A partnership group, including delivery of effective, accessible, under the national strategy. representatives from health care, personalised and preventive universities and higher education health and social care services. Several government agencies have institutions, industry, patients and Stakeholders in the life sciences assignments and responsibilities professions, advises the life sci- sector have different assignments, in the life sciences area, such ences innovation partnership clients and priorities, and work as regulation, supervision and programme and the Life Sciences towards similar but somewhat issuing permits. Their areas of Office. Through cross-sectoral different goals. This gives the responsibility are related from mobilisation, this innovation sector an inherent complexity, various perspectives, which is why partnership programme aims to making collaboration and coor- collaboration between them is tackle major health challenges dination more difficult. Stake- vital. They are key actors in and strengthen Sweden’s global holders in the sector demonstrate developing the sector and innovation capacity and competi- strong engagement and a clear Sweden’s attractiveness as an tiveness. The National Innovation understanding that collaboration international partner. A number Council, led by Sweden’s Prime is key to achieving improve- of government agencies come Minister, works closely with ments. Collaboration is also together in the Council for these innovation partnership important for achieving greater Knowledge Management.5 The programmes. staff mobility and skills develop- Council’s work helps ensure that ment throughout the sector. the right knowledge reaches In addition to the innovation the responsible authorities and partnership programmes, the Collaboration is particularly professions in health care and Government has undertaken a important in relation to the social services. Linked to the range of other initiatives to regional responsibility for planning Council is an inter-agency group, strengthen national collaboration. and delivering health care, and comprising representatives from The Swedish Governmental Agency coordinating and facilitating regions and municipalities, which for Innovation Systems (Vinnova) regional development. The is tasked with informing the funds strategic innovation pro- grammes that facilitate national 5Ordinance on central government knowledge management in health care and social services mobilisation and make common (2015:155, in Swedish). priorities and initiatives between
12 Sweden’s national life sciences strategy sector stakeholders possible. Objectives In life sciences, the strategic inno- vation programmes Swelife and 1.1 Strengthened national coordination in life sciences Medtech4Health play an impor- The Government wants to strengthen the Swedish life sciences sector tant role. Moreover, the Swedish through clear national leadership. The Life Sciences Office contributes Research Council funds Clinical to more effective collaboration, cooperation and coordination. Studies Sweden, a network of Collaboration between government agencies is key to ensuring that regional nodes aimed at strengthen- a uniform national approach is achieved for the development of life ing the conditions for conducting sciences in Sweden. clinical studies in Sweden. Nordic cooperation on policy 1.2 Partnerships for regional and national mobilisation issues would improve the possibility The Government considers it essential that developments in life sciences of using combined population and are conducted jointly and in a coordinated manner – at national, patient bases. Continued develop- regional and local level – in close collaboration with industry, universities ment of Nordic cooperation – and higher education institutions. Partnership with the regions can including on clinical research and demonstrate a shared ambition for life sciences and create conditions clinical studies, the use of bio- for realising it. banks and health data, patient mobility and the application of 1.3 Nordic region – a world-leading life sciences hub artificial intelligence – would In the Government’s assessment, broader Nordic cooperation can improve the entire region’s contribute to increased competitiveness. Joint policy development competitiveness in relation to the efforts can contribute to harmonised implementation of new digital global life sciences sector. solutions and precision medicine.
Sweden’s national life sciences strategy 13 2. Unlocking the potential of health data for use in research and innovation
System solutions to unlock the more accessible than previously. the technology to share data potential of health data are The transition to mainly digital (technical interoperability), the use essential to enable Sweden to management of personal data in of the same terms/context spearhead developments in life both social services and health care references by those who input sciences. Huge volumes of data – has taken place at the same time data to the system (semantic ‘real-world data’ – are generated as these areas have undergone interoperability) and a legal basis daily in self-management, health changes in their organisation and for processing data generated in and social care. A prerequisite for responsibilities. Consequently, another activity (legal interoper- using this data to develop future the need for information sharing ability). Secure identification and care and preventive interventions between care providers or practi- authorisation solutions are other is compliance with legislative tioners to provide good and safe requirements. There are a number requirements for protection of health and social care, while of areas in which existing legisla- privacy, such as protection of maintaining privacy and security, tion – regulating how data may be natural persons with respect to has increased in recent years. In used for research and innovation processing personal data, public light of this, the Government – is interpreted differently by dif- access to information and secrecy, considers that a review of certain ferent stakeholders. This includes information security and security issues in the area is required and personal data processing carried protection.6 has therefore appointed an out in health care for sample size inquiry.7 Enabling data to be used calculation (pre-screening of po- Technological developments mean in research, innovation and tential patients ahead of clinical that the volume of health data is development requires interoper- trials) and the regulation of more extensive and potentially ability. This includes, for example, research that includes acutely unconscious patients. The fact that legislation is interpreted What is Real-World Data? differently may be due to varying There is no single, generally accepted definition of ‘real-world levels of knowledge among data’. In this context, it refers to information on the treatment stakeholders, but it is also due to and health of individuals, found in registers and medical records, actual ambiguities and obstacles and lifestyle information collected through mobile applications that may need to be addressed or and wearable technology. Such data is not collected primarily clarified. for scientific use, but it can be used for research in accordance with existing regulatory frameworks. Findings from observational At the same time, the changing use studies based on data from everyday clinical practice are called of new technology and new inno- ‘real-world evidence’. vations based on data sharing and interconnected information systems makes threats more difficult to 6National strategy for society’s information and cyber security (Govt Communication 2016/17:213). detect, risks more difficult to assess 7ToR 2019:37 Review of certain issues relating to personal data processing in social services and health care services and dependencies more difficult (in Swedish). to examine. This poses particular
14 Sweden’s national life sciences strategy Ilustration: Science Photo Library/TT Nyhetsbyrå
Sweden’s national life sciences strategy 15 challenges for information involves, for example, clarifying parties11 states that the registers management in vital public ser- and, when necessary, changing should be used as a source of vices such as health and social regulatory frameworks, devel- knowledge for clinical research, care. Medical records and registers oping a more consistent use of including cooperation with the contain particularly sensitive per- terms, and standardisation. The life sciences sector. Other regis- sonal data, which raises questions Swedish eHealth Agency has been ters include the national health about public access to information tasked with coordinating this data registers. These are individual- and secrecy, data protection and work.9 based registers, provided by the privacy protection. The sharing of National Board of Health and patient data and access to various Proper access to current data is Welfare, and cover inpatient and types of registers bring many of needed to monitor and improve some outpatient care interven- these issues into the limelight. the quality of health and social tions, dental care, causes of death The same applies to assistive tech- care services. It is also an impor- and prescribed drugs. There are nologies in health and social care, tant tool in making health and also biobanks, which are collec- and research and infrastructure. social care services more effective, tions of samples prepared from gender-equal and equitable across human biological material such as Data generated in health and social the country. Certain government blood samples. Within the care is stored in a variety of sys- agencies, such as the Dental framework of Biobank Sweden, tems, such as medication modules, and Pharmaceutical Benefits regions and higher education imaging diagnostic systems, labo- Agency, rely on data to carry out institutions are cooperating to ratory reports and medical records their tasks. This requires access to build an integrated health care systems. An essential prerequisite quality-assured data on care infrastructure for biobanks. The for making data accessible is that interventions and outcomes at dif- Biobank Inquiry12 has submitted the regions ensure that their ferent levels and for different proposals to adapt this legislation investments in future medical stakeholders. To broaden data to facilitate developments and information systems take interna- accessibility, especially in relation improve conditions for using tional standards and open plat- to the shift to delivering more samples and information in forms into account, and that these quality and local health care, the Swedish biobanks to meet the systems are developed to conform National Board of Health and needs of patients, health care and with strict standards of informa- Welfare has been tasked with de- research. The Inquiry has also tion security. Making data veloping the national follow-up proposed establishing a national accessible also involves enabling plan for primary care.10 sample register (the national data analysis and eliminating the biobank register).13 need to transfer data from various Certain health data is transferred sources for use in research and to different types of national or The Swedish Research Council innovation (e.g. federating data). regional registers. The diagnosis- maintains the Register Utiliser The Vision for eHealth,8 adopted by specific ‘quality registers’ have Tool (RUT), a metadata tool that the Government and the Swedish developed over a long period of can be used to quickly gain a Association of Local Authorities time with the aim of improving quality-assured overview of the and Regions, states that, by 2025, and ensuring health care quality. information that is available and Sweden will be the best in the In recent years, central government can be linked from different regis- world at using the opportunities and the regions have made joint ters. RUT includes national public offered by digital transformation investments in these registers. An authority registers, national qual- and eHealth. This joint commitment agreement between the ity registers, research-generated data and biobanks. New registers are being added to optimise the 8https://ehalsa2025.se/in-english/. use of data in research, enabling 9S2019/01521/FS Assignment to make available and manage common national specifications (in Swedish). RUT to function as a national 10S2019/03056/FS Assignment to develop the national follow-up plan for primary care (in Swedish). portal for sources of register 11S2019/02385/FS Authorisation to sign an agreement on support to national quality registers in 2019 (in Swedish). data. Health data is also stored 12The Biobank Inquiry was tasked with reviewing legislation regulating the management of human biological material privately by individuals – in health in biobanks. apps to monitor personal progress 13SOU 2018:4 Biobanks of the future, the Inquiry’s final report (in Swedish). and in medical device apps that
16 Sweden’s national life sciences strategy assist patients with self-manage- Objectives ment of chronic diseases. Surveys show that the Swedish 2.1 Effective and secure sharing of patient data population is generally positive The Government considers that regions and municipalities need better about the use of their anonymised conditions for sharing patient data between different care providers. data in health care research and 14 The basic premise is to strengthen these developments in data sharing development, but people want to while continuing to deliver safe and quality health care, and while be informed if they are added to a also respecting privacy and ensuring information security requirements register and want to be able to opt are met. out.15 A group of chronic disease patients, known as ‘lead 2.2 Increased use of health data in research and innovation user patients’ (spetspatienter), are The Government would like the use of health data in research and already contributing knowledge innovation to increase, while maintaining privacy protection, and data generated as they partici- to contribute to improved patient care and industry development. pate in self-management. Self- Ambiguities and obstacles to processing health data, and associated reported data has great potential ethical considerations, need to be addressed. This is essential to for use in care, and in research and strengthen Sweden’s prominent position in digital transformation and innovation. However, to enable data use. At the same time, sectoral knowledge of applicable legislation such data to be shared, solutions needs to be improved. must be developed so sharing can take place while ensuring infor- 2.3 Effective, secure and ethical use of register data mation security and privacy The Government considers that the life sciences sector’s use of register protection. data for research and innovation should increase. It is essential that infrastructure, legislation, guidelines and other forms of support Efforts around the globe to contribute to the effective, secure and ethical use of quality registers promote access to and unlock the and health data registers, for example, and that a review is conducted of potential of health data for use in patient opportunities to self-report their data. research and innovation are currently attracting global tech 2.4 Better use of biobanks companies. The driving force is The Inquiry on the regulation of biobanks has submitted a proposal for potential synergies gained by a new biobank act. The Government intends to consider the proposal partnering with life sciences during this electoral period. Developing the use of biobank samples stakeholders on the use of health should be made possible, provided that sample donor privacy is data. However, the interest of respected. Secure and stable structures are also needed for storing, searching and retrieving information and samples from biobanks. companies in accessing and using public data generated in Sweden 2.5 Follow-up using real-world data must be balanced against the In the Government’s assessment, the possibility to follow up and use protection of the individual’s basic real-world data needs to improve. This involves good conditions for rights and freedoms, such as collecting and analysing such data, including self-reported data. protection of privacy, including protection of natural persons with respect to processing personal data, and must observe the impor- tance of maintaining a high level of public trust in the open society.
14Research!Sweden’s 2019 opinion poll.
15For safety’s sake, Swedish Agency for Health and Care Services Analysis, report 2017:10 (in Swedish).
Sweden’s national life sciences strategy 17 3. Responsible, secure and ethical policy development
As artificial intelligence (AI) and welfare and competitiveness.17 This (ATMPs), offer potential cures precision medicine are introduced requires long-term measures for and may be used for patient in health care, the need for knowledge-building, skills sup- groups currently on lifelong policy development increases. ply, access to large volumes of treatment or without treatment This includes adapting regulatory high-quality data and computa- options. These new medicinal frameworks, approaches and tional capabilities, along with products pose major challenges working practices to be able to be- effective national and interna- for financing and pricing systems, nefit from technological develop- tional frameworks to guarantee as they have a high treatment cost ments and new innovations. transparency, trust, security, per patient and treatment. For Implementation must also take privacy protection and an ethical traditional medicinal products, into account continued rapid tech- approach. This ambition is well this cost may be spread over a nological developments, including in line with the Government’s long treatment period and, if the the constant need for updating, Digital Strategy, with the objec- treatment is ineffective, it can be and robustness and redundancy re- tive that Sweden will be the world discontinued. Regarding ATMPs, quirements. The Government has leader in harnessing the opportu- there is considerable uncertainty appointed the Committee for nities offered by digital transfor- at present about the long-term Technological Innovation and mation.18 However, the use of AI effects. Because such treatments Ethics (KOMET)16 for coordi- in health care in Sweden is still are given on one occasion, this nated and accelerated policy devel- limited.19 National investments uncertainty needs to be con- opment. KOMET will continuously in cross-sectoral cooperation are sidered in connection with pricing deliver input on precision medicine being made by AI Innovation of and decisions concerning their and other areas. Policy develop- Sweden.20 Alongside this, private use. However, these new therapies ment to enable increased focus on financiers have made major could result in a lower overall cost both prevention and implementa- investments in AI research, includ- to society, but new working prac- tion requires active collaboration ing a billion-kronor investment tices would be required. ATMPs between government agencies. by the Knut and Alice Wallenberg also challenge current working Foundation. practices in terms of evaluation, Sweden’s ambition is to be a regulatory approval and intro- leader in harnessing the opportu- Certain new gene and cell duction. The clinical studies on nities that AI can offer, with the therapies, known as advanced which regulatory approval is often aim of strengthening Sweden’s therapy medicinal products based include only a small num- ber of patients, which is why in- troduction into health care delivery is 16 ToR 2018:85 Coordinated and accelerated policy development linked to fourth industrial revolution technologies. based on limited data volumes. 17N2018.14 National approach to artificial intelligence. This places greater demands on 18N2017/03643/D For sustainable digital transformation in Sweden – a Digital Strategy. follow-up, i.e. constant access to 19Digital care services and artificial intelligence in health care, National Board of Health relevant data (see also priority and Welfare report, 2019 (in Swedish). area 2), and regulatory framework 20https://www.ai.se/en. development based on
18 Sweden’s national life sciences strategy Illustration: AstraZeneca
Sweden’s national life sciences strategy 19 knowledge-building through treatment of patients who consent care could improve the prospects international collaboration in to give their time and data to for early diagnosis and preventive regulatory sciences, as conducted these studies (see also priority interventions in primary care, for by the Swedish Medical Products area 4). In addition, equal opportu- instance. Agency. nities should also exist to enable patients to take part in clinical New regulatory frameworks for Research and development that is studies, regardless of where they medical devices21 and in vitro increasingly data-driven and largely live in Sweden. diagnostic medical devices22 will based on sensitive personal data apply from May 2021 and May requires high security standards, To better harness patients’ 2022, respectively. Sweeping both in terms of technology and potential and expertise, flexibility changes in these new regulations privacy. The General Data is needed with respect to where clarify the importance of new Protection Regulation regulates and when health care interven- working practices and policy the processing of personal data on tions are conducted. In the future, development. In several cases, a general level. Processing per- it should be possible for some of the regulations require further sonal data in this area encompasses the interventions currently con- evaluations of existing products as both general and sector-specific ducted in hospitals and health a result of stricter requirements. data protection regulations. centres to take place to a greater The adaptations required for this extent at home. Perhaps this ap- are expected to represent a major Using sensitive personal data plies primarily, but not exclusively, challenge for medical technology for research purposes requires to patients with chronic diseases companies, particularly in view an ethical review. The organisa- who are well informed about their of the considerable shortage of tion for ethical reviews in Sweden health condition. Enabling patients notified bodies23 at present. If was recently changed through to take certain tests on their own evaluation and certification of the establishment of the Swedish at home, for example, can save new medical devices take a long Ethical Review Authority. More- resources while patients save time time because of the shortage of over, from 2020 an independent spent on travel. Providing more notified bodies, there is a risk that board will be responsible opportunities for patients to Swedish companies and researchers for investigations and decisions manage their own care can thus will choose to look abroad to related to research misconduct in benefit both the health care develop medical device innovations. the form of fabrication, falsifica- system and the individual. This tion or plagiarism of data. means that user needs must be Access to information from public considered in the development of registers for research purposes services and products. Increased is regulated in the Public Access patient and user influence is there- to Information and Secrecy Act fore a key policy issue in the area (2009:400). of life sciences.
An ethical approach in clinical Collaboration between dental care research, however, involves more and health care is important, elements than effective structures as a large proportion of the popu- and legislation. It is essential that lation regularly seeks dental care. any clinical studies conducted are Dental examinations can poten- of high quality so that findings tially be used to detect diseases can be used and implemented. that are not directly related to oral Anything else would be unethical health. Health screening in dental
21Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
22Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
23Notified bodies are independent organisations that assist and monitor manufacturers’ efforts to verify that products comply with EU regulations, https://www.swedac.se/services/notified-appointed-bodies/?lang=en.
20 Sweden’s national life sciences strategy Objectives
3.1 Efficient process for implementing new therapies The Government considers it necessary to optimise the time between the approval and implementation of new therapies. Greater knowledge is needed about how authorities responsible for health care can manage the costs and uncertainties associated with ATMPs, and what the need for new business and investment models will be. Moreover, better conditions are needed for conducting health technology assessments on medical devices in precision medicine.
3.2 Accelerated, secure and ethical policy development The Government considers that the public sector’s ability to identify and propose changes to regulatory frameworks, applications and working practices needs to be developed. The need for accelerated, secure and ethical policy development through policy labs, for example, is particularly great in terms of regulatory aspects. Sweden should be the country of choice for introducing new diagnostics and therapies, based on its excellence in regulatory issues.
3.3 Implementing new medical device regulations The Government considers that access to notified bodies in Sweden must correspond to sector needs. It is crucial to ensure that notified bodies are in place so that the new medical device regulations can be applied.
3.4 Greater focus on preventive interventions and self- management The Government considers that Sweden should increase its focus on health and prevention, including both preventive interventions to prevent the development of ill health and fully developed diseases, and initiatives to prevent recurrences (primary and secondary prevention). Improving capacity for early diagnosis will create better conditions for early treatment, prevention and self-management.
Sweden’s national life sciences strategy 21 4. Integration of research and innovation into care delivery
New knowledge – in the form of health-promotion methods, products and treatments – is best developed and evaluated where care recipients are found, using their expertise and cooperation in the development process. Research and innovation need to be core components of health care, dental care and social care services. Collaboration with industry and academia is essential. This will require practical conditions and clear incentives. It must be organi- sationally and financially Photo: Sahlgrenska Universitetssjukhuset feasible for staff to take part, while their participation also needs to create added value for the partici- pating patients, staff and services. Sweden’s national cancer strategy dental care, ensures that research The ongoing structural changes in and the structure of six collabo- and innovation are natural parts of the health care system, including rating regional cancer centres can these services’ remit and that increased focus on primary care be seen as a model for coordinated greater opportunities are provided and a greater degree of level clinical development and for relevant implementation. structuring of highly specialised implementation of new knowl- care, are changing the conditions edge. Furthermore, the regions’ Cooperation between central for research and innovation in health care knowledge manage- government and the regions care delivery. ment system, which also includes on medical training, clinical research and the development of health care is regulated by the ALF What is the ALF agreement? agreement.24 When the agreement The ALF agreement provides almost SEK 2 billion per year in was renewed in 2015, a system was remuneration from central government to the regions for clinical introduced to regularly evaluate research (SEK 1.89 billion in 2020). the quality of health care and
Source: ALF, the agreement between Sweden’s central government and seven regions on clinical research conducted at the medical training, clinical research and the development of health care university hospitals. According to the most recent ALF evaluation, 24The agreement between Sweden’s central government and seven regions on medical training, Swedish clinical research is of clinical research and the development of health care. high quality.25 Access to quality 25Evaluation of the quality of clinical research in the regions covered by the ALF agreement, registers and biobanks provides Swedish Research Council, 2018.
22 Sweden’s national life sciences strategy favourable conditions for conduct- develop conditions for clinical Major challenges – the need for ing clinical research in Sweden. studies in Sweden through regional access to digital health data, Greater coordination, based on nodes. In the 2000s, the number expertise and infrastructure – are national strategies, would further of clinical trials of medicinal expected at all levels of the health improve the quality. The evaluation products dropped in Sweden; this care system, as precision medi- also points to the need for greater has often been interpreted as a cine’s new, advanced diagnostics internationalisation of Sweden’s reduction in clinical research in and treatment are developed and health care, for example through general. But this is not the case in introduced. Neither highly spe- programmes for clinical practice terms of the funding of clinical cialised care services nor medical and scientific work abroad. research or the number of applica- device and product manufacturers tions for ethical review.26 Never- can develop and make these Cooperation with the regions also theless, sector stakeholders perceive treatments available on their own. takes place within the framework that conditions for conducting of Clinical Studies Sweden, a clinical research have deteriorated Within the framework of collaboration between Sweden’s in recent years, as time and resources Genomic Medicine Sweden, six health care regions funded and are increasingly in short supply in central government and the supported by the Swedish Research the health care system. regions are collaborating to build Council. The aim is to support and up a national infrastructure for
Health expenditure as a percentage of GDP in 2015 and projected changes for 2015–2030
25%
20%
15%
10%
5%
0% UK Italy USA Chile Israel Spain Japan Latvia Turkey France Poland Ireland Austria Mexico Iceland Greece Finland Estonia Canada Norway Czechia Sweden Slovakia Belgium Slovenia Portugal OECD36 Hungary Australia Germany Lithuania Denmark -5% Colombia Switzerland Netherlands South Korea Luxembourg 2015 Förändring 2015 - 2030New Zealand
2015 Change 2015–2030
Health expenditure as a percentage of GDP in 2015 and projected changes for 2015–2030. Source: OECD Health at a glance, 2019
26The number of applications increased from 2 077 in 2010 to 2 461 in 2018 (excluding applications to make changes), figures from the Swedish Research Council, based on annual reports of the ethical review boards.
Sweden’s national life sciences strategy 23 Photo: Sahlgrenska University Hospital
24 Sweden’s national life sciences strategy implementing precision medicine in Objectives Swedish health care services. The initiative originated in 4.1 Incentives and good opportunities to combine clinical practice the Swedish Science for Life and research Laboratory (SciLifeLab) and is The Government considers that good conditions for combining clinical largely based on the infra- practice and research throughout the health care system are essential. structure offered there. The goal is The combination of both clinical and research expertise is important to make new whole-genome for the continued development of Sweden’s health care system. It is sequencing technologies available, also important to create equivalent conditions in social care services. cost-effectively and equitably, throughout the country and 4.2 More industry-initiated clinical studies in Swedish health care establish regional genomic The Government wants more clinical studies, conducted in medicine centres at the university collaboration with industry, to be located in Sweden. For Sweden to hospitals. be able to compete for future studies, infrastructure is needed that permits rapid application in clinical use and effective evaluation of diagnostics and treatment outcomes. Ensuring that the health care system has the resources and expertise needed to take part in industry collaboration is also important.
4.3 High-quality clinical studies The Government considers it important that clinical studies conducted in Sweden’s health care system are of high quality. High quality is imperative to ensure that research findings can contribute to innovation, and be implemented and of benefit to patients and in health care.
4.4 Pioneering the introduction of precision medicine in care services The Government wants Sweden to pioneer the implementation of precision medicine in health care services. This will require sustainable, supportive structures for diagnostics, bioinformatics and intelligent digital decision-support systems for prevention and treatment, and remuneration systems that encourage innovation and implementation of new technologies.
Sweden’s national life sciences strategy 25 5. Assistive technologies for increased independence, participation and health
New digital services and health and municipalities are currently with built-in sensors and assistive technology solutions have engaged in implementing assistive connectivity to be controlled and major potential to improve health technology solutions in their share data via the internet. This and develop health care and social activities, but progress is slow.27 increasing number of IoT-based care services through prevention, For example, there is a lack of solutions further reinforces the habilitation and rehabilitation. knowledge about how assistive need for information security. The use of wearable technology technologies can best be inte- and remote monitoring, for ex- grated into care services. This Technological solutions are ex- ample, creates new opportunities includes both how these products pected to create new working to support individuals and should be designed to ensure practices that may increase the provide system-level monitoring. quality standards and usability, attractiveness of working in the At the same time, perspectives and new working practices. To welfare sector. This will also such as privacy protection, infor- increase this knowledge, public result in a broader labour market mation security, robustness and sector employees need to be in- for technology and data profes- redundancy must inform imple- volved in research work. Vinnova sionals. But it will require ethical mentation. This will create has co-financed several program- considerations and further exami- conditions for more equitable mes aimed at more effectively nation of the legal framework for health and increased quality and identifying and harnessing existing the use of digital technologies, and effectiveness in activities, while knowledge and ideas within the skills development initiatives for creating new business opportu- public sector. staff, especially in ethics. An nities. To achieve this at system important issue will be the extent level, more effective public-private Digital health care services can, to which assistive technologies partnerships are required that for example, improve access to can be used in health and social include clear user involvement. initial care contacts and the ability to care for people with impaired provide continuous monitor- decsion-making capacity. Digital technologies can increase ing. Sweden’s launch of the 5G security, confidence, participation network is planned in 2020. By Municipal health care services and independence for everyone. offering higher speeds and mini- comprise a large part of the total They can help improve quality of mal latency, while guaranteeing a health care system. In 2016, life, particularly for older people stable connection, 5G will municipal expenditure was and people with disabilities, and enable the introduction of new around SEK 127 billion, equiva- include wearable technology or and more advanced monitoring and lent to 26 per cent of total health mobile applications that provide remote care services. The internet care expenditure.28 As many reminders or support. Most of things (IoT) enables equipment municipalities are small and have limited resources, there is a call for collaboration between 27Advances in eHealth and assistive technologies in the municipalities in 2019, National Board of Health and Welfare municipalities, clearer national follow-up survey (in Swedish). coordination and governance, 28The state of play and advances in health, medical and dental care, National Board of Health and Welfare status report (in Swedish). and national support.
26 Sweden’s national life sciences strategy Age distribution of Sweden’s population
Population disaggregated by gender and age in 2018 and 2070 (projection)
100+ yrsår
90-94 åryrs
80-84 åryrs
70-74 åryrs mänMen 20182018 60-64 åryrs män,Men 2070 prognos (projection) 2070
50-54 åryrs kvinnorWomen 2018
Women 2070 (projection) 40-44 åryrs kvinnor, prognos 2070
30-34 åryrs
20-24 åryrs
10-14 åryrs
0-4 yrsår 450450000 000 350350000 000 250250000 000 150000150 000 5000050 000 5000050 000 150000150 000 250000250 000 350000350 000 450000450 000 Men Women
The Government has therefore will be almost 90 years for women they have different expectations tasked the National Board and almost 87 years for men. This of health and social care com- of Health and Welfare with means that the proportion of pared with previous generations. strengthening support to munici- older people in the population is An increasing proportion of older pally financed health care ser- increasing. In 2017, almost every people with extensive and com- vices. The assignment is based fifth person was over the age of plex health and social care needs on the action plan presented in 65. As the population ages, the currently receive this care at the National Board of Health and risk of disease and multimorbidity home. The digital transformation Welfare’s report, Municipally increases. At present, people aged in social care must be supported financed health care services – pilot 80 and older account for around by technological solutions com- study (in Swedish). Support in- 5 per cent of the population, but mon to all public administration cludes both knowledge necessary by 2050 they are expected to to provide the best conditions for for developing care services at account for around 9 per cent. good operational support for both system level and for ensuring high To address the growing need for professionals and care recipients. quality staff-patient interaction. health and social care services, both systems need to be developed. There are considerable knowledge In the future, life expectancy gaps in the scientific evidence for is expected to increase in most Older people in Sweden today are many areas within the mandate countries around the world. active well into their older years of social services. The Swedish Statistics Sweden’s 2016 popula- and, by international compar- Research Council for Health, tion projection estimates that life isons, have a high level of tech- Working Life and Welfare (Forte) expectancy in Sweden in 2060 nology uptake.29 This means that is responsible for the national programme on applied welfare research, which works to improve 29 Swedes and the Internet 2019, Swedish Internet Foundation survey. knowledge in social services.
Sweden’s national life sciences strategy 27 Photo: Viktor Bjurlid /Totalskidskolan
The programme includes the PhD most important for increased re- and the working practices of studies initiative, which aims search include how social services social services to contribute to long-term can work on implementing, disin- knowledge-building in social vesting and introducing evidence- services. In partnership with the based knowledge, what methods Swedish Agency for Health Tech- can be used to follow up on nology Assessment and Assess- interventions, and how the parti- ment of Social Services (SBU), cipation of service users and their Forte has also conducted a sur- relatives can be developed within vey of the research needs in social social services to improve the services.30 The areas assessed as situation for care recipients/clients
30Priorities for research on social services – perspectives from users, policy-makers and practitioners, SBU and Forte, 2019.
28 Sweden’s national life sciences strategy Objectives
5.1 Harnessing the potential of assistive technologies To improve quality and provide more effective working practices, the Government sees the need to accelerate digital transformation through better use of assistive technologies in care services and to promote preventive interventions, while also ensuring that privacy protection, information security, robustness and redundancy inform implementation. Assistive technology solutions need to be integrated into activities and, in some cases, linked to existing operational systems in care services to achieve the greatest possible benefit.
5.2 Development and collaboration for implementation The Government sees the need for increased collaboration between regulatory authorities and industry. This collaboration aims to support the rapidly growing sector for health and assistive technology companies in Sweden by providing knowledge about regulatory frameworks that enable these companies to develop products and services in accordance with applicable legislation in the area. This will improve the opportunities for these companies to grow on a global market, with local ties in Sweden.
Photo: Justem Johnsson, Scandinav/ TT Nyhetsbyrån
Sweden’s national life sciences strategy 29 6. Research and infrastructure
Research of the highest inter- research and innovation. For life In recent years and in collabo- national standards is important sciences, the partnerships in the ration with industry and other for Sweden’s development and mission area ‘Cancer’ and part- stakeholders, the Government prosperity in a globalised world. nership programmes will be key. has invested in ‘innovation hubs’. In contrast to those of central The proposed Digital Europe Two examples are BioVentureHub, government, industry investments programme for 2021–2027, which co-located at AstraZeneca in in research in Sweden have fallen includes investments in AI and Mölndal, and Testa Center in for a number of years, particularly health data processing, is relevant Uppsala. The AstraZeneca as a result of major global in this context. BioVentureHub offers access to corporations choosing to locate a larger share of their research to international research Sweden as a research and innovation nation environments outside of Sweden. This underscores the need for Sweden is one of the countries that invests the most in research, excellent and world-class research measured as a percentage of GDP. In 2018, the total expenditure at Swedish universities and higher for research and development conducted in Sweden amounted education institutions, and strong to approximately SEK 157 billion, corresponding to 3.3 per cent incentives for collaborating with of GDP. Of this amount, public funding corresponded to the surrounding community. 0.9 per cent of GDP.
International partnerships and Sweden was named the EU innovative leader in 2019. contexts are needed to enable Sweden was the country that had the highest number of Swedish research to advance and researchers per capita in 2015, and demonstrates a high level for research quality to improve. of scientific productivity, as measured by the number of They are also needed to tackle publications per 1 000 inhabitants. transnational social challenges and address the 2030 Agenda. Among Swedish research is of high scientific standard. Sweden’s share of international financiers, the EU is highly cited publications is just over 11 per cent, placing Sweden the most significant for Swedish 13th among the countries of the world. researchers. Up to March 2019, Sweden had been granted EUR The Times Higher Education World University Rankings 2020, 1.4 billion in funding from the which includes almost 1 400 universities across 92 countries, research and innovation frame- ranked five Swedish universities among the top 200: Karolinska work programme Horizon 2020 Institutet (41), Lund University (96), Uppsala University (102), in eighth place after countries that Stockholm University (175) and the University of Gothenburg (186). all have larger populations than Sweden. The next framework pro- Sources: Budget Bill for 2020 (Govt Bill 2019/20:1); European innovation scoreboard; Swedish Research Council, Swedish Research Barometer 2019; Times Higher Education World University Rankings 2020 gramme, Horizon Europe, will be the world’s largest investment in
30 Sweden’s national life sciences strategy Photo: Johan Persson, MAX IV, Lund university
Sweden’s national life sciences strategy 31 the company’s expertise and Protein Research, funded mainly sciences research. In proximity infrastructure for research groups by the Knut and Alice Wallenberg to MAX IV, the European from universities and higher Foundation. Spallation Source (ESS) is under education institutions and small construction. It is currently one of enterprises in pharmaceuticals Research and innovation in life the largest, highest priority and medical technology. It has sciences are completely dependent research infrastructure projects also initiated a mentoring scheme on access to advanced research in Europe, hosted by Sweden and targeting university incubators infrastructure. Important Swedish Denmark. The ESS will be fully and science parks. Testa Center facilities in this area include operational in 2025 and will be offers environments and infra- SciLifeLab, MAX IV and the the world’s most powerful neut- structure for research, development Swedish National Infrastructure ron source, with applications in and production of biopharmaceuti- for Computing (SNIC). drug development, for instance. cal products, targeting companies SciLifeLab is a national resource All these infrastructures generate and research groups at universities centre offering infrastructure of enormous volumes of data, which and higher education institutions. the highest international standard must be managed effectively and Testa Center is part of a larger for molecular biosciences focus- efficiently. Life sciences research billion-kronor investment in ing on health and environmental is becoming increasingly data- biopharmaceuticals that the research. The centre has facilities driven, requiring advanced infra- Government has made in collabo- in Stockholm and Uppsala, but structures for data processing. ration with private stakeholders. involves collaborative projects The initiative includes a national with a number of universities Higher education institutions that programme for protein research, around the country. MAX IV host research infrastructures method development and bio- Laboratory, outside Lund, has generally offer access not only pharmaceuticals production, the world’s strongest synchrotron to equipment, but also to the and the Wallenberg Center for X-rays for materials and life staff, expertise and the
Photo: AstraZeneca
32 Sweden’s national life sciences strategy materials necessary to use the Objectives equipment. Advanced infra- structure is an important platform 6.1 Strengthened cross-sectoral life sciences research for cross-sectoral collaboration. In the Government’s view, cross-sectoral research and innovation that The business model for using contribute to the sustainable development of health and wellbeing in research infrastructure therefore line with the 2030 Agenda are a top priority. Free basic research is the needs to be reviewed to enable foundation for being able to address health challenges in the long term. these costs to be shared by users. State funding for the construction 6.2 Excellent life sciences research infrastructure and operation of national and The Government wants Swedish life sciences researchers to have international research infra- access to high-quality research infrastructure and to strengthen structures also needs to be re- Sweden’s position as a Big Science nation. viewed to ensure the effective use of available funds to pay for both 6.3 Increased and broader use of research infrastructure current and new investments. The Government wants the use of Swedish research infrastructure to increase and wants users to represent a broad range of stakeholders to stimulate cross-sectoral collaboration.
6.4 Strengthened infrastructures for data-driven research and innovation The Government considers that there is a need to strengthen digital infrastructure – such as computational resources for calculations and analyses, cost-effective data storage, advanced user support and increased network capacity for digital communication – to enable the processing of greater volumes of increasingly complex data.
6.5 Increased Swedish participation in EU programmes The Government wants stakeholders in Sweden to work actively to influence the implementation of the next research and innovation framework programme, Horizon Europe, so that it addresses Swedish needs, priorities and strengths.
Sweden’s national life sciences strategy 33 7. Skills supply, talent attraction and lifelong learning
Skills supply for life sciences digital transformation, automation specialised skills. Measures are companies and the public sector and globalisation of activities needed both to effectively recruit must be ensured to enable Sweden results in rapid changes in the internationally and to improve to compete as a leading life sciences skills required. Greater need for conditions nationally to produce nation. In a globalised world, with lifelong learning – in the form of the skills in demand. increasing mobility of individuals, in-service training and further the labour market and educational education of practising professionals, Sweden’s attractiveness as a study institutions are becoming more and career change training – destination is dependent on many and more international and requires flexible solutions. factors, including high-quality competition is intensifying for education, courses offered in both students and people with Life sciences is a knowledge- English, gender-equal career cutting-edge expertise. Continuing intensive sector, often requiring paths, and conditions for a good study and social life for students. The Inquiry on increased interna- tionalisation of higher education activities31 has described factors for internationalising both educa- tion and research at universities and higher education institutions, and submitted proposals for mea- sures to increase Sweden’s attrac- tiveness as a study destination. A special visa for highly qualified people wanting to apply for jobs or start a business will be introduced on 1 January 2021. The aim is to facilitate collaboration with inter- nationally leading research and innovation environments, and attract and retain international cutting-edge expertise.
Skills supply is currently a parti- cular challenge for the segment
Photo: Department of Philosophy, Lund University of the life sciences industry with production in Sweden.32 This 31SOU 2018:3 Internationalisation of Swedish Higher Education and Research – A Strategic Agenda. segment generates a continuous 32N2015/08694/IF Assignment on a national programme for protein research, method development need for specialist expertise in and biopharmaceuticals production (in Swedish). areas such as automation, ‘lean’
34 Sweden’s national life sciences strategy methodology, analysis, process Objectives engineering, chemical engineering and good manufacturing prac- 7.1 Good opportunities for lifelong learning tices. The major pharmaceutical The Government considers that there must be good opportunities companies have traditionally func- for lifelong learning. This is important for the life sciences sector, tioned as a base for further where knowledge is advancing at a rapid pace and the skills required can training in drug development, change quickly. Cross-sectoral staff mobility is also encouraged. but as the number of these com- panies have declined, skills supply 7.2 Effective collaboration to ensure skills supply in the area has become problem- The Government considers that effective collaboration and a cross- atic. One way of managing this sectoral approach is necessary to ensure long-term skills supply in the problem is by actively making the life sciences sector. It is essential that future challenges are managed in skills in major companies avail- collaboration with the education sector and employers in life sciences. able to small enterprises. 7.3 Offering competitive conditions to recruit internationally The welfare sector is also The Government wants conditions in place to enable employers in facing major challenges in terms Sweden to recruit international expertise in the life sciences sector. of future skills supply. The National Board of Health and Welfare’s survey33 of supply and demand of licensed health care staff found that the regions consider that there is a shortage of staff in several regulated professions, despite a general increase in supply of licensed staff over time. One reason for this is considered to be the increased demand for care services. Care conducted at university hospitals plays a key role in fulfilling the health care system’s mandate to perform clinical research. This involves special needs in the form of research-trained staff.
It is also essential to better harness the knowledge and ideas available in health care and social services. Involving those working in the health and social care sector in product and service development increases the poten- tial to achieve functional out- comes. This also raises skill levels, both in the health and social care sector and in the companies developing health and assistive technologies.
33Assessment of supply and demand of licensed staff in health and dental care, National Board of Health and Welfare report, 2019 (in Swedish).
Sweden’s national life sciences strategy 35 8. International attractiveness and competitiveness
Investments and export promo- institutions or global life sciences sciences offerings. The Offices of tion are two fundamental compo- companies, higher education in- Science and Innovation at nents of the internationalisation stitutions’ innovation offices and Sweden’s embassies in Beijing, of Swedish life sciences. To ensure holding companies all play an Brasilia, New Delhi, Seoul, Tokyo that Sweden is an attractive invest- important role in the innovation and Washington DC have been ment country in a global and system supporting life sciences. tasked with analysing strategic digital knowledge-based society, A structure for long-term collabo- initiatives in their respective it is crucial to be able to offer ration between the country’s busi- countries that are relevant for all an environment that includes ness incubators, with cutting- the innovation partnership world-leading universities and edge expertise in life sciences, is programmes, including the higher education institutions, an essential to ensure high interna- programme for health and life innovative and high-quality health tional standards in the business sciences. Business Sweden and care system, and government incubator process. Swecare are also important actors in agencies with a clear mandate to investment and export promotion. contribute to policy develop- Actively monitoring international Under the name ‘Team Sweden’, ment and innovation at system developments and analysing they work in partnership with level. Close collaboration with advances in the life sciences other stakeholders in the sector to our Nordic neighbours is, in some sector in Sweden, at both national promote life sciences exports. areas, a prerequisite for achieving and regional level, is important to attractive environments. Coopera- be able to market Sweden’s life Sweden currently has a relatively tion with the United Kingdom is also vital for Swedish stakeholders. In the Horizon 2020 framework programme, ‘Societal Challenge 1 – Health, Demographic Change and Wellbeing’, the UK is Sweden’s most important partner country. With its outstanding life sciences sector, the UK will continue to be an important partner in the future too. Innovation partner- ships with France, Germany and India will also create opportuni- ties for in-depth partnership projects and policy advocacy.
Research infrastructures, test beds and incubators with links to universities and higher education Photo: Erik Flyg, Karolinska Institutet
36 Sweden’s national life sciences strategy large and growing number of life Objectives sciences companies in the start-up phase. The high number of initial 8.1 Better business environment for research and development public offerings of such compa- The Government intends to raise the ‘R&D deduction’ to facilitate nies, particularly on active small Swedish industry’s continued investment in new technology and cap equity markets, is unique in high-knowledge content. an international perspective. Yet the number of venture capitalist 8.2 Increased export and investment promotion investors has fallen from around In line with the Government’s export and investment strategy, Sweden ten at the turn of the millennium should be positioned and marketed as a country of choice for global to currently two – including stakeholders when it comes to establishment, investment, and Industrifonden – that specialise in research and innovation collaboration in the life sciences sector, life sciences. As the listing including in precision medicine. environment and stock markets can change rapidly, and the 8.3 World-class business incubators refinancing cycles for life sciences The Government considers that it is important for Sweden to be able to companies are becoming ever offer competitive business incubators. Growth companies in the life shorter, private and public venture sciences sector need access to world-class expertise, regardless of capital is a very important source where in the country the company is located. of financing. 8.4 Continuous monitoring, analysis and follow-up Early investments with high or The Government considers that continuous analysis and follow-up of difficult-to-assess risk levels and/ life sciences, both nationally and internationally, is essential. Knowledge or delayed returns (which charac- about Sweden’s performance in relation to comparable countries is terise the life sciences sector) imperative if Sweden is to market itself as a country of choice for life generally have difficulty attract- sciences investment. ing private financing. Central government investments in life sciences have also sought out companies in later development phases in recent years. Saminvest AB is a wholly state-owned venture capital company that invests indirectly through privately managed funds using a ‘fund of fund’ structure. In partnership with private stakeholders, Saminvest has established a new venture capital fund focused on Nordic life sciences companies.
Competitive framework conditions for companies investing in research are important for the localisation of global companies. The conditions and working methods of regulatory authorities are also important. Intellectual property law is also part of the framework that is the basis for innovation, company formation, product development, collaboration and trade. Photo: Erik Flyg, Karolinska Institutet
Sweden’s national life sciences strategy 37
Sweden’s national life sciences strategy 39 Government Offices of Sweden Switchboard: +46 8–405 10 00 www.government.se