Life sciences road map pathway to a national strategy

Transcription

1 Life sciences road map pathway to a national strategy

2 Illustrations: Itziar Castany Ramirez Production: Ministry of Enterprise and Innovation Article no: N

3 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 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 Structures 2. Clinical treatment studies as an investment 3. Introduction and dissemination of new, effective treatment methods

4 Introduction Sweden aims to be a leading life sciences nation. Tackling tomorrow s societal challenges and maintaining a competitive life sciences sector requires a common goal a strategy and consensus on the initiatives 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 per cent of health care costs. 2 Global health threats, such as pandemics and antibiotic resistance, further burden the health care system. Sweden has the necessary prerequisites 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 solutions will create better opportunities for high-quality, equitable, gender-equal and accessible health care and social services. 1 Lägesrapport 2018 (Status report 2018), Research!Sweden. Sweden has major economic interests in the life sciences sector. Each year, life sciences companies export products valued at SEK 95 billion 3 (approximately 7 per cent of total exports) and the sector employs around people. 4 Sweden aims to be an attractive international test market for the global industry to attract new investments. International competition is tough, and conditions for operating in Sweden must be improved. In its bill Knowledge in collaboration (2016/17:50), the Swedish Government 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 skilled employment opportunities. Issues such as skills supply, research and innovation need to be addressed to pave the way for Sweden s next generation of strengths and future export areas. This requires collaboration and common priorities. Similarly, constant dialogue with higher education institutions is essential to ensure that future skills needs are met. 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 ), PM 2018:06, 6 April 2018, Swedish Agency for Growth Policy Analysis (Growth Analysis). Sweden must safeguard and constantly develop the conditions necessary to ensure that new knowledge is quickly and effectively transformed into innovative diagnostic methods and treatments, thus advancing health care. This requires an open culture that encourages innovation at both individual 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 innovation lead to societal development, prosperity and business competitiveness, and respond to the societal challenges we face, both in Sweden and globally. Life sciences is one of three areas alongside digital transformation, and environment and climate that the National Innovation Council has identified as a particular priority in its work. An innovation partnership programme and a national coordinator have contributed 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 The office has been 4 Life science road map pathway to a national strategy

5 tasked with promoting knowledge development, innovation and excellence in health and social care, and at higher education institutions. It has also been tasked with improving conditions for establishing and operating life sciences companies in Sweden. Life science road map pathway to a national strategy 5

6 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 strategy 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 partnership programme for life sciences and the national coordinator s work and recommendations 5 are the starting point for the work on the strategy. This national strategy must be based on contributions from all actors in the field. A dialogue is therefore under way, which will continue in the latter half of 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 proposals for the future direction of the work. Common and monitorable objectives both short- and longterm will be set. The strategy will provide the conditions for improved health by increasing innovation and advancing health and social care, giving global visibility to Swedish strengths and pointing the way to future export revenues. This roadmap 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. 6 Life science road map pathway to a national strategy

7 work going forward. It highlights three priorities of particular importance for advancing Sweden s life sciences sector and high-quality, equitable, gender-equal and efficient health care. Utilisation of digital health care data Large volumes of data are generated in an individual s contacts with health care and social services. Used correctly, this information 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. products and treatments must be developed and evaluated where patients and users are found, utilising their expertise and cooperation in the development process. 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. Precision medicine tomorrow s diagnostics, treatment and cure Individualised health care that offers tailored forms of treatment is developing rapidly. Precision medicine, involving advanced diagnostic methods such as genetic analysis and high-resolution imaging 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 mutations in newborn babies, for example, 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 market with cutting-edge expertise to attract new investments in patient-focused research and development. Tomorrow s health and social care integrating research and innovation All new knowledge in the form of health-promotion methods, Life science road map pathway to a national strategy 7

8 Priority: Utilisation of digital health and health care data Developing the use of data is a key issue for future health Each day, health care services produce huge volumes of data that are stored in medical records systems and registries at national, regional and local level, including the national health data registries and the national quality registries. Social 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 increasingly able to collect and save different types of data. The challenge is how to leverage this information and use it in health-promotion, research and innovation. Efforts must take place in collaboration with the various professions, and with patients and users, to benefit from expertise and experience from different perspectives. Partnering with several industry sectors will be important to identify needs, develop solutions and harness the great international potential that access to data offers. The long-term goal is improved interoperability, i.e. promoting compatibility of different data management systems by using well-defined national and international standards. This will facilitate sharing and reusing data in line with the FAIR data management principles (findable, accessible, interoperable, reusable). To ensure patient security and personal privacy, clear rules in the form of appropriate legislation are required. 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 individual data processed in public sector eservices, which is why work on privacy and legislation must be coordinated. National structure and initiatives Considerable efforts are already under way in the field, and this work must continue. The Government and the Swedish Association of Local Authorities and Regions (SALAR) have adopted a Vision for ehealth 2025, which describes joint commitments to improve 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 provide clearer focus for efforts in the field of artificial intelligence (AI). In addition to this, the Government is supporting the development of the national quality registries 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 higher education institutions are cooperating to build up an integrated health care infrastructure for biobanks. A metadata Register Utiliser Tool (RUT) has been developed by the Swedish Research Council for its website registerforskning.se in order to facilitate access to registry data. Focus areas 1. Legal basis There is a need to clarify the legal basis for processing patient and user data linked to research and development work. Efficient access to information is essential, while it is also important to guarantee personal privacy. The legal basis must be reviewed systematically to create the conditions for using data to improve and develop health and social care. To leverage the potential of individualbased data, forms of broad consent need to be developed where this is relevant. 8 Life science road map pathway to a national strategy

9 2. National coordination to ensure interoperability Interoperability and common standards for appropriate information management in public sector activities are a fundamental 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 initiatives as well. This sector is information-intensive, and many of the methods and solutions being developed are dependent on access to health care data. Achieving more appropriate data management requires both better collaboration and clearer national coordination 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 biobanks There are currently around 450 biobanks in Sweden that are supplied with approximately 3 4 million samples each year. Biobank samples are a valuable resource for medical research and clinical trials. The procedure for the structured collection of samples has been developed in recent years, but other aspects of biobank management can still be developed further. The final report of the Inquiry Biobanks of the future (Framtidens biobanker, SOU 2018:4), which the Government has not yet taken a position on, points to the need of a national registry of existing biobanks to ensure national access and traceability of biobank samples, including a fit-for-purpose IT infrastructure. The utilisation of the quality registries and other health data for research and development should be developed. Systems for releasing information must be coordinated so that researchers 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. Life science road map pathway to a national strategy 9

10 Priority: Precision medicine tomorrow s diagnostics, treatment and cure A new approach Precision medicine refers to diagnostic methods and therapies for individualised screening, prevention and treatment of disease, applied at individual level or to specific sections of the population. The new opportunities offered by precision medicine are based on recent advances in e.g. molecular biosciences (the omic technologies) and bioinformatics, 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 infrastructure (see below) in combination with a comprehensive approach to policy development and an openness to effectively implementing innovations such as AI and precision medicine can help set Sweden apart in the international market as a leader in research, innovation and investments in the field. Sweden can be a pioneer nation The 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 currently 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 introduce precision medicine to health care. Genomic Medicine Sweden uses powerful sequencing techno- 10 Life science road map pathway to a national strategy

11 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 tomorrow s individualised care. In recent years, the Government has made major investments to promote development and production of biological medicinal products throughout the value chain. Establishing the Centre for Advanced Medical Products has been part of this. The Centre aims to accelerate development and implementation of new ATMPs in health care. Major investments are also being made in MAX IV and the European Spallation Source (ESS), two complementary, world-leading research infrastructure facilities of great importance to the entire life sciences sector. Focus areas 1. Policy development With regard to cutting-edge technologies and expertise in both basic and translational research, and treatment research, Sweden is well prepared to introduce precision medicine to health care. However, to fully harness the most recent advances, a new framework 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 quality. The Swedish Medical Products Agency is at the forefront of conducting regulatory reviews at European level. Relevant government agencies must also continue to be able to participate in the development process internationally to steer efforts in the right direction and give international visibility to Sweden s work. 2. Investments and broadened utilisation of national infrastructure During the transition to more individualised care, initiatives 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 accessible to both private and public actors to ensure the Government receives the best return on its investment. Joint use of the facilities would also encourage collaboration 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 valuecreation 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 preventively 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 optimal treatment for individual patients. At the same time, collaboration and change management are required to enable secure and qualitative needs-based implementation in health care and social services. There is uncertainty concerning how the EU General Data Protection 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 applications. One important factor in striking this balance is the collaboration 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 , Vinnova (Sweden s innovation agency). Life science road map pathway to a national strategy 11

12 Priority: Tomorrow s health and social care integrating research and innovation Research, development and innovation as a natural part of everyday health and social care Knowledge is advancing rapidly today, and new technologies are helping to increase our understanding of how and why diseases develop. This new knowledge needs to be translated into diagnostic methods, medical technology, medicinal products or other treatments to benefit patients. Health care services have a critical role to play in this, not just as users of new innovations, but also as producers of them. New products and treatments must be tested and evaluated where patients are, often through an iterative process, which is why research and development must be an integral part of health care services. This also applies to the development of assisted living technology solutions and other forms of digital support, where both social services and potential users of these innovations should be involved at the development stage to ensure maximum usability. For this to work, health and social care services must collaborate with both higher education institutions and the business sector. A fundamental 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 knowledge. The knowledge and perspectives of patients and users must also be leveraged in a new way with regard 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 technology and securing Sweden s competitiveness in the life sciences sector. Health care is a complex activity, making it difficult to determine which factors impact the research environment. Costeffectiveness is required under the Health and Medical Services Act, but it can be difficult to estimate the profits derived from innovation, as they sometimes arise in another part of the organisation. This is why it is important to continue knowledge-building and development 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 initiatives The Government is making major investments in health care to address demographic challenges while maintaining quality and cost efficiency. A comprehensive reorganisation has been initiated that will reinforce local health care and make primary care the clear foundation. Efforts have also begun to concentrate the most highly specialised care at national level. An inquiry has also been appointed to review compensation models and management systems in health care. In addition, the Government recently made changes concerning the management of Clinical Studies Sweden at the Swedish Research Council, with the aim of creating better conditions for collaboration and support. County councils and regions, in turn, have decided to jointly support and finance a coherent knowledge management system to provide more knowledge-based, equitable and resource-efficient 12 Life science road map pathway to a national strategy

13 care of high quality. All actors must keep pace with developments to create the best possible conditions for research and innovation in health and social care. Focus areas 1. Structures Swedish health and social care services should carry out research and innovation as an integral part of their activities and in collaboration with higher education institutions 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 identify elements that overlap or are missing and, in cooperation with other actors, discuss what such a system should look like. A discussion 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 investment Although the number of incoming clinical trials of medicinal products taking place in Sweden increased somewhat between 2014 and 2016, viewed over a longer period of time the number has declined, remaining relatively stable at just over 300 trials per year. 7 Sweden can do more; this trend must be reversed and more companies attracted to Sweden to conduct their clinical studies here. To succeed in this, Sweden must credibly market itself as a testbed for innovative clinical trials of new medicinal products and effective evaluations of treatment outcomes in real time using health care registries. This will help achieve significantly shorter development times at lower costs for new generations of medicinal products and more rapid access to new and improved patient therapies. 3. Introduction and dissemination of new, effective treatment methods Good 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 , Growth Analysis. Life science road map pathway to a national strategy 13

14 Government Offices, Sweden Switchboard: Street address: Ministry of Enterprise and Innovation, Mäster Samuelsgatan 70, Stockholm