life sciences road map – pathway to a national strategy · 2018-10-23 · life science road map...

Life sciences road map – pathway to a national strategy

Illustrations: Itziar Castany RamirezProduction: Ministry of Enterprise and Innovation Article no: N2018.34

Contents

Introduction 4

Pathway to a national strategy 6

Priority: Utilisation of digital health and health care data 8

Developing the use of data is a key issue for future health 8

National structure and initiatives 8

Focus areas 8

1. Legal basis

2. National coordination to ensure interoperability

3. Increased use of registries and biobanks

Priority: Precision medicine – tomorrow’s diagnostics,

treatment and cure 10

A new approach 10

Sweden can be a pioneer nation 10

Focus areas 11

1. Policy development

2. Investments and broadened utilisation of national infrastructure

3. Artificial intelligence

Priority: Tomorrow’s health and social care

– integrating research and innovation 12

Research, development and innovation as a natural part of everyday health and social care 12

Ongoing structural reviews and initiatives 12

Focus areas 13

1. Structures

2. Clinical treatment studies as an investment

3. Introduction and dissemination of new, effective treatment methods

4 Life science road map – pathway to a national strategy

Introduction

Sweden aims to be a leading life sciences nation. Tackling tomor-row’s societal challenges and main-taining a competitive life sciences sector requires a common goal – a strategy – and consensus on the in-itiatives needed to move forward. Like many other countries, Sweden has an ageing population and an increase in chronic illnesses. The number of people over the age of 80 is expected to double within 23 years.1 Approximately 50 per cent of Sweden’s population has one or more chronic diseases, estimated to represent 80–85 per cent of health care costs.2 Global health threats, such as pandemics and antibio-tic resistance, further burden the health care system.

Sweden has the necessary prere-quisites to pioneer life sciences – excellence in research, one of the world’s best health care systems and a well-educated population that is quick to adopt new technologies. Innovation and cost-effective solu-tions will create better opportuni-ties for high-quality, equitable, gen-der-equal and accessible health care and social services.

Sweden has major economic in-terests in the life sciences sector. Each year, life sciences companies export products valued at SEK 95 billion3 (approximately 7 per cent of total exports) and the sector employs around 42 000 people.4 Sweden aims to be an attractive in-ternational test market for the glo-bal industry to attract new invest-ments. International competition is tough, and conditions for operating in Sweden must be improved. In its bill ‘Knowledge in collaboration’ (2016/17:50), the Swedish Govern-ment stated that Sweden needs to strengthen its position to become a world leader in life sciences, which can result in increased investments, more exports and more highly skil-led employment opportunities. Issues such as skills supply, research and innovation need to be addres-sed to pave the way for Sweden’s next generation of ‘strengths’ and future export areas. This requires collaboration and common prio-rities. Similarly, constant dialogue with higher education institutions is essential to ensure that future skills needs are met.

Sweden must safeguard and constantly develop the conditions necessary to ensure that new know-ledge is quickly and effectively transformed into innovative diagnostic methods and treat-ments, thus advancing health care. This requires an open culture that encourages innovation at both in-dividual and organisational level, where all actors contribute to the process of change within the framework of their specific roles.

The Government’s goal for research policy is for Sweden to be a world leader in research and innovation, and a leading knowledge nation, where excellence in research, higher education and inno-vation lead to societal development, prosperity and business competiti-veness, and respond to the societal challenges we face, both in Sweden and globally. Life sciences is one of three areas – alongside digital trans-formation, and environment and climate – that the National Innova-tion Council has identified as a par-ticular priority in its work. An inn-ovation partnership programme and a national coordinator have contri-buted to the Government’s efforts and to most of the initiatives that have been carried out in the area. The Government Offices has had a life sciences coordination function – an office for life sciences– since February 2018. The office has been

1 Lägesrapport 2018 (Status report 2018), Research!Sweden.

2 VIP i vården? (VIPs in health care?) 2014:2, Swedish Agency for Health and Care Services Analysis.

3 Handlingsplan för life science för ett konkurrenskraftigare Sverige (Life sciences action plan for a more competitive Sweden), Swedish Association of the Pharmaceutical Industry (LIF), SwedenBIO and Swedish Medtech, 2017 statistics.

4 Den svenska life science-industrins utveckling – statistik och analys (Growth in Sweden’s life science industry 2014–16), PM 2018:06, 6 April 2018, Swedish Agency for Growth Policy Analysis (Growth Analysis).

Life science road map – pathway to a national strategy 5

tasked with promoting knowledge development, innovation and excel-lence in health and social care, and at higher education institutions. It has also been tasked with impro-ving conditions for establishing and operating life sciences compa-nies in Sweden.


Pathway to a national strategy

A long-term, holistic approach is necessary to move the life sciences sector forward. The Government has decided that the life sciences office will produce a national stra-tegy to guide the work of creating a functional ecosystem and thus the best possible conditions for life sciences. The overall results achieved by the innovation part-nership programme for life scien-ces and the national coordinator’s work and recommendations5 are the starting point for the work on

the strategy. This national stra-tegy must be based on contribu-tions from all actors in the field. A dialogue is therefore under way, which will continue in the latter half of 2018. Collaboration and broad engagement will enable the development of a strategy that has broad support and points the way forward towards common goals. Based on the life sciences sector’s needs and the Government’s priorities, the strategy will identify both areas of strength and propo-

sals for the future direction of the work. Common and monitorable objectives – both short- and long-term – will be set.

The strategy will provide the con-ditions for improved health by increasing innovation and advan-cing health and social care, giving global visibility to Swedish strengths and pointing the way to future export revenues. This road-map has been produced as a basis for discussion and support in the

5 En nationell samordnare för området livsvetenskap (A national coordinator in the field of life sciences), U 2015:08.


work going forward. It highlights three priorities of particular im-portance for advancing Sweden’s life sciences sector and high-quali-ty, equitable, gender-equal and ef-ficient health care.

Utilisation of digital health care dataLarge volumes of data are gene-rated in an individual’s contacts with health care and social servi-ces. Used correctly, this informa-tion can play a crucial role in the development of tomorrow’s disease prevention, treatment and cure. The challenge is to develop systems and processes to better leverage the data collected and use it in development, prevention and research.

Precision medicine – tomorrow’s diagnostics, treatment and cureIndividualised health care that of-fers tailored forms of treatment is developing rapidly. Precision med-icine, involving advanced diagnos-tic methods such as genetic analysis and high-resolution ima-ging technologies, is contributing to this development. Advances in the field have made it possible today to analyse an individual’s genetic makeup within 24 hours. The early detection of genetic mu-tations in newborn babies, for ex-ample, makes treatment possible that may prevent severe disabilities. Developments are taking place around the world, but Sweden is well ahead and able to position itself as an international test mar-ket with cutting-edge expertise to attract new investments in patient-focused research and development.

Tomorrow’s health and social care – integrating research and innovationAll new knowledge in the form of health-promotion methods,

products and treatments must be developed and evaluated where patients and users are found, uti-lising their expertise and coope-ration in the development pro-cess. Integrating and prioritising research and development in health care, at both regional and local level, and in social services, can ensure that new knowledge is put to good use. Culture and leadership are important in the change process, although support and joint initiatives at several levels may also be necessary.


Priority: Utilisation of digital health and health care data

Developing the use of data is a key issue for future healthEach day, health care services pro-duce huge volumes of data that are stored in medical records systems and registries at national, regio-nal and local level, including the national health data registries and the national quality registries. So-cial services are increasingly using digital health devices and assisted living technologies, providing the opportunity to collect and leverage information that may be of great importance in developing new digital support systems. In addition to this, individuals are in-creasingly able to collect and save different types of data. The chal-lenge is how to leverage this infor-mation and use it in health-pro-motion, research and innovation. Efforts must take place in colla-boration with the various profes-sions, and with patients and users, to benefit from expertise and ex-perience from different perspecti-ves. Partnering with several indu-stry sectors will be important to identify needs, develop solutions and harness the great internatio-nal potential that access to data offers. The long-term goal is im-proved interoperability, i.e. promo-ting compatibility of different data management systems by using well-defined national and interna-tional standards. This will facili-tate sharing and reusing data in

line with the FAIR data manage-ment principles (findable, acces-sible, interoperable, reusable). To ensure patient security and perso-nal privacy, clear rules in the form of appropriate legislation are re-quired. Transparency is needed to ensure continued high levels of legitimacy and confidence among those who share their health data. This applies to all forms of indivi-dual data processed in public sector eServices, which is why work on privacy and legislation must be coordinated.

National structure and initiativesConsiderable efforts are already under way in the field, and this work must continue. The Govern-ment and the Swedish Association of Local Authorities and Regions (SALAR) have adopted a ‘Vision for eHealth 2025’, which descri-bes joint commitments to impro-ve interoperability. It highlights initiatives focusing on technical standards, more consistent use of terms, and appropriate laws and regulatory frameworks. The Government has also produced a digital strategy, with the aim of Sweden being a world leader in harnessing the potential of the digital transformation. At the same time, the Government’s new strategy, ‘National approach for artificial intelligence’, will provi-

de clearer focus for efforts in the field of artificial intelligence (AI).

In addition to this, the Govern-ment is supporting the develop-ment of the national quality re-gistries through an agreement with SALAR. Several investments have been made to improve the process of building up biobanks. Within the framework of Biobank Sweden, county councils and hig-her education institutions are coo-perating to build up an integrated health care infrastructure for bio-banks. A metadata Register Utili-ser Tool (RUT) has been developed by the Swedish Re-search Council for its website registerforskning.se in order to facilitate access to registry data.

Focus areas1. Legal basisThere is a need to clarify the legal basis for processing patient and user data linked to research and development work. Efficient ac-cess to information is essential, while it is also important to gua-rantee personal privacy. The legal basis must be reviewed systemati-cally to create the conditions for using data to improve and develop health and social care. To leverage the potential of individual- based data, forms of broad consent need to be developed where this is relevant.


2. National coordination to ensure interoperabilityInteroperability and common standards for appropriate infor-mation management in public sector activities are a fundamen-tal part of the Vision for eHealth 2025 and the action plan linked to it. The Vision highlights issues concerning sharing responsibility for eHealth initiatives, and these efforts must be developed further to support vital life sciences initia-tives as well. This sector is infor-mation-intensive, and many of the methods and solutions being de-veloped are dependent on access to health care data. Achieving more appropriate data manage-ment requires both better collabo-ration and clearer national coor-dination with respect to digital health care data for research and innovation. The FAIR principles must serve as a guide.

3. Increased use of registries and biobanksThere are currently around 450 biobanks in Sweden that are supp-lied with approximately 3–4 mil-lion samples each year. Biobank samples are a valuable resource for medical research and clini-cal trials. The procedure for the

structured collection of samp-les has been developed in recent years, but other aspects of bio-bank management can still be developed further. The final report of the Inquiry ‘Biobanks of the future’ (Framtidens bio-banker, SOU 2018:4), which the Government has not yet taken a position on, points to the need of a national registry of existing bio-banks to ensure national access and traceability of biobank samp-les, including a fit-for-purpose IT infrastructure. The utilisation of the quality registries and other health data for research and de-velopment should be developed. Systems for releasing information must be coordinated so that re-searchers and the business sector have appropriate access to data. Several registries have already been connected to the Register Utiliser Tool (see above), but all registries should be connected to optimise the use of data in research.


Priority: Precision medicine – tomorrow’s diagnostics, treatment and cure

A new approachPrecision medicine refers to diagnostic methods and thera-pies for individualised screen-ing, prevention and treatment of disease, applied at individual level or to specific sections of the population. The new opportuni-ties offered by precision medicine are based on recent advances in e.g. molecular biosciences (the ‘omic’ technologies) and bioin-

formatics, and the emergence of new high-resolution imaging technologies. Together, advances in these areas allow diagnosis at cell and molecular level of both disease-related risk factors and fully developed disease states, and the possibility of completely new, individually tailored treatments.

Alongside this transition to more individualised care, focus is also

needed on prevention within health care. Major gains for individuals and society can be achieved through more effective prevention of disease and curative treatment.

The investments that have been made in supporting national in-frastructure (see below) – in com-bination with a comprehensive approach to policy development and an openness to effectively im-plementing innovations such as AI and precision medicine – can help set Sweden apart in the in-ternational market as a leader in research, innovation and invest-ments in the field.

Sweden can be a pioneer nationThe transition to more individualised health care is already under way. The Science for Life Laboratory (SciLifeLab) for large-scale molecular bioscience research has gradually been built up through central government and private investments and cur-rently offers world-class research infrastructure. This has laid the foundation for Genomic Medicine Sweden, an initiative that aims to create a national infrastructure for molecular diagnostics and intro-duce precision medicine to health care. Genomic Medicine Sweden uses powerful sequencing techno-


logy to provide medical diagnoses by analysing patients’ genetic material.

Advanced therapy medicinal products (ATMPs) – medicinal products based on cells, tissues or genes – are predicted to become important cornerstones in tomor-row’s individualised care. In re-cent years, the Government has made major investments to pro-mote development and produc-tion of biological medicinal pro-ducts throughout the value chain. Establishing the Centre for Ad-vanced Medical Products has been part of this. The Centre aims to accelerate development and im-plementation of new ATMPs in health care. Major investments are also being made in MAX IV and the European Spallation Source (ESS), two complementa-ry, world-leading research infra-structure facilities of great impor-tance to the entire life sciences sector.

Focus areas1. Policy developmentWith regard to cutting-edge tech-nologies and expertise in both basic and translational research, and treatment research, Sweden is well prepared to introduce pre-cision medicine to health care. However, to fully harness the most recent advances, a new fra-mework in which to operate is required. Policy development in privacy, ethics, and compensation and business models is needed. The approval time for new types of treatments, and the process for setting prices and subsidies, must be as short as possible without compromising security or quali-ty. The Swedish Medical Products Agency is at the forefront of con-ducting regulatory reviews at

European level. Relevant govern-ment agencies must also continue to be able to participate in the development process internatio-nally to steer efforts in the right direction and give international visibility to Sweden’s work.

2. Investments and broadened utilisation of national infrastructureDuring the transition to more individualised care, initiati-ves such as Genomic Medicine Sweden (see above) are needed to support health care and accelerate the shift. It is important that such infrastructure is broadly acces-sible to both private and public actors to ensure the Government receives the best return on its in-vestment. Joint use of the facili-ties would also encourage collabo-ration by increasing the points of contact between higher education institutions and companies. Increasing the infrastructure’s openness to companies would also make investing in Sweden more attractive for global companies.

3. Artificial intelligence Sweden has significant value- creation potential in the use of AI in industry and the public sector.6 Potential benefits in health care lie in the possibility of using AI to work preven- tively via early detection of health problems. AI can improve the quality of life for people needing care. For example, assisted living technologies and digital support may enable older people to live at home longer. Applying AI to diagnostic methods that use image processing software may improve diagnostic quality and efficiency and the choice of opti-mal treatment for individual patients. At the same time,

collaboration and change manage-ment are required to enable secure and qualitative needs-based imple-mentation in health care and social services.

There is uncertainty concerning how the EU General Data Pro-tection Regulation will be applied in Sweden. The need for privacy protection, ethical frameworks, trust and social protection must be balanced against the access to data required to advance AI app-lications. One important factor in striking this balance is the colla-boration of regulatory authorities and experts with other actors in research and innovation processes where new AI applications are developed.

6 Artificiell intelligens i svenskt näringsliv och samhälle (Artificial intelligence in Swedish business and society), Ref. no 2017-05616, Vinnova (Sweden’s innovation agency).


Priority: Tomorrow’s health and social care – integrating research and innovation

Research, development and innovation as a natural part of everyday health and social careKnowledge is advancing rapidly today, and new technologies are helping to increase our understan-ding of how and why diseases develop. This new knowledge needs to be translated into diag-nostic methods, medical techno-logy, medicinal products or other treatments to benefit patients. Health care services have a criti-cal role to play in this, not just as users of new innovations, but also as producers of them. New pro-ducts and treatments must be tested and evaluated where pa-tients are, often through an iterati-ve process, which is why research and development must be an in-tegral part of health care services.

This also applies to the develop-ment of assisted living technology solutions and other forms of digi-tal support, where both social ser-vices and potential users of these innovations should be involved at the development stage to ensu-re maximum usability. For this to work, health and social care ser-vices must collaborate with both higher education institutions and the business sector. A fundamen-tal prerequisite to ensure that any advances in knowledge benefit health care services is ensuring that employees in this sector have relevant and up-to-date knowled-ge. The knowledge and perspecti-ves of patients and users must also be leveraged in a new way with re-gard to both their own treatment and systems development.

Creating clear incentives for research and innovation in health care is essential to harnessing the benefits of rapid advances in tech-nology and securing Sweden’s competitiveness in the life sciences sector. Health care is a complex activity, making it difficult to de-termine which factors impact the research environment. Cost- effectiveness is required under the Health and Medical Services Act, but it can be difficult to estima-te the profits derived from inno-vation, as they sometimes arise in another part of the organisation.

This is why it is important to con-tinue knowledge-building and de-velopment of economic models, for example. Challenges facing the social services sector may also make it difficult for social services providers to make room for innovations and trial activities in the services they provide.

Ongoing structural reviews and initiativesThe Government is making major investments in health care to address demographic challenges while maintaining quality and cost efficiency. A comprehensive reor-ganisation has been initiated that will reinforce local health care and make primary care the clear foun-dation. Efforts have also begun to concentrate the most highly speci-alised care at national level. An in-quiry has also been appointed to review compensation models and management systems in health care. In addition, the Govern- ment recently made changes con-cerning the management of Clinical Studies Sweden at the Swedish Research Council, with the aim of creating better condi-tions for collaboration and sup-port. County councils and regions, in turn, have decided to joint-ly support and finance a coherent knowledge management system to provide more knowledge-based, equitable and resource-efficient


care of high quality. All actors must keep pace with developments to create the best possible condi-tions for research and innovation in health and social care.

Focus areas1. StructuresSwedish health and social care services should carry out research and innovation as an integral part of their activities and in collabora-tion with higher education insti-tutions and the business sector. A first step in these strategic efforts is to begin surveying structures for knowledge management and innovation related to roles and interfaces. The aim is to identi-fy elements that overlap or are missing and, in cooperation with other actors, discuss what such a system should look like. A discus-sion of this nature is essential, not least considering the process of change currently taking place in the health care sector.

2. Clinical treatment studies as an investmentAlthough the number of inco-ming clinical trials of medicinal products taking place in Sweden increased somewhat between 2014 and 2016, viewed over a long-er period of time the number has declined, remaining relatively sta-ble at just over 300 trials per year.7 Sweden can do more; this trend must be reversed and more com-panies attracted to Sweden to con-duct their clinical studies here. To succeed in this, Sweden must cre-dibly market itself as a testbed for innovative clinical trials of new medicinal products and effective evaluations of treatment outco-mes in real time using health care registries. This will help achieve significantly shorter development times at lower costs for new gene-

rations of medicinal products and more rapid access to new and improved patient therapies.

3. Introduction and dissemination of new, effective treatment methodsGood conditions are essential to promote collaboration between the public and business sectors. Only then can we develop ways to introduce, disseminate and evaluate new treatments in health care, at regional and local level. Efforts must be informed by change-oriented leadership that views implementing innovations as an investment. Follow-up and comparisons of innovation efforts and more rapid implementation need to take place at several levels.

7 ‘Growth in Sweden’s life science industry 2014–16’, Growth Analysis.

Government Offices, SwedenSwitchboard: +46 8-405 10 00Street address: Ministry of Enterprise and Innovation, Mäster Samuelsgatan 70, Stockholmwww.government.se

life sciences road map – pathway to a national strategy · 2018-10-23 · life science road map...

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