sou · GXB343 · 2009-05-05 00:00:00 — Ett sådant huvudmannaskap skulle medföra att svensk hälso- och sjukvård skulle ställas under tre huvudmän. Detta kan medföra svårhanterliga gränsdragningsproblem. Även stiftelseformen har övervägts. Dess främsta nackdel består i att den utgör en icke- flexibel och oföränderlig organisation. Ett landstingsägt UMC i bolagsform skiljer sig ur forskningssynpunkt inte märkbart från nuvarande verksamhetsform och är inte särskilt ägnad att tillför- säkra forskningen dess ställning. Ansvaret för UMC blir med bolagsmodellen automatiskt samlat till dess styrelse och ledning. Fördelen är att man får ett väl utveck- lat organisationsmönster med klara roller för ägare, styrelse och verkställande direktör vilket underlättar ett partnerskap. Genom dess styrelse och verkställande ledning ges bolaget hela ansvaret för planering, styrning och drift av UMC. Med en samlad organisation för alla delar av verksamheten skapas även tydlighet gentemot det omgivande samhället inklusive industri och forskningsfinansiärer. Detta möjliggör samverkan i skilda former. och sta- tens inbördes förhållande och inflytande garanteras genom ägar- avtal, bolagsordning och ägardirektiv. I de landsting där bolagsmodellen inte bedöms möjlig att genomföra måste ändå en förändring komma till stånd för att åstadkomma UMC. Utifrån analys av alternativen anser utred- ningen att förvaltningsmodellen med landstingen som ägare men med nytt ledarskap och ökat forskningsfokus är den form som har näst bäst förutsättningar att skapa UMC. För att forskningsresultaten ska få en chans att göra nytta krävs ett ansvar och finansiering av forskningens hela utvecklingskedja, från explorativ forskarinitierad verksamhet till implementering i vården. är själva implementeringen av forskningsresultaten en flask- hals och ett förbisett område då ingen av de berörda forsknings- finansiärerna känner ansvar. Därför görs ingen stor och tydlig satsning på detta område. Även kliniska studier av olika slag och vetenskapliga utvärderingar av nya metoder saknar finansiellt stöd liksom epidemiologiskt uppföljningsarbete. Följden blir att nya läkemedel, behandlingar och diagnostiska metoder inte kommer patienten till del och vården får ingen kvalitetshöjning. Möjlig- heterna att pröva nya metoder och fasa ut gamla blir begränsade. statistik visar att antalet icke-industrisponsrade, forskarinitierade kliniska läkemedelsprövningar successivt har minskat , vilket i första hand hänger samman med att dessa är kostsamma och att det saknas tydliga finansiärer. Även industrin har med sitt innovationsarbete en viktig roll i implementeringsarbetet. Industrin efterlyser förbättrade möjlig- heter till samverkan med universiteten och sjukvården för att kunna utveckla nya innovationer. Samverkan mellan olika forskningsfinansiärer kan ge gynn- samma effekter när det gäller att förstärka den kliniska forsk- ningens avtryck i vården. Ett gemensamt nationellt resurstillskott för implementering och innovation bör därför skapas där olika stat- liga myndigheter som och samverkar med sjukvårdshuvudmännen, akademi, stiftelser och industri. Fond för klinisk behandlingsforskning Utredningen föreslår att en fond för klinisk behandlingsforskning byggs upp med en årlig finansiering omfattande . Fonden ska vara samfinansierad. Staten bör bidra med och övriga finansiärer, framför allt , landstingen, stiftelser och fonder, bör tillföra lika mycket. En fondkommitté utses av finansiärerna med ansvar för planering, fördelning, beredning och uppföljning. Administrativt bör kommittén placeras vid ämnesråd för medicin och hälsa. För att underlätta samarbete och genomförande av kliniska behandlingsstudier krävs en för uppdragsgivare och utförare gemensam kontaktyta. Utredningen föreslår därför att en nationell samarbetsorganisation bildas för Akademisk medicinsk behand- lingsforskning i (SAMS). SAMS ska utgöra ett centrum för nätverk av sjukvårdskliniker, kliniska forsknings- och prövnings- centra, och universitet. Organisationen ska ledas av en styrelse bestående av forskare från samtliga universitetssjukhus. Klinisk forskning förutsätter tillgång till bl.a. högteknologisk utrustning, IT-stöd, biobanker och olika kvalitets- och hälsodata- register. Detta är kostnadskrävande infrastrukturer med ett natio- nellt och ofta även internationellt intresse som kan utnyttjas av olika forskargrupper. Det är därför angeläget att organisera och optimera de svenska resurserna så att dessa kan få full verknings- grad tillsammans med europeiska och andra internationella infra- Utredningen pekade i sitt delbetänkande på att nya resurser och bättre nationell samordning krävs. Nuvarande satsningar på biobanker, kvalitets- och patientdataregi- ster samt IT-stöd är otillräckliga, trots att erhållit ett visst ökat stöd för infrastruktur. Det ankommer på ansvariga myndigheter att samordna dessa resurser och göra dem tillgängliga för större nationella forskningssatsningar. Inom EU görs omfattande och samordnade satsningar på infra- struktur inom ramen för Infrastructure in Medicine (ESFRI). För att ska kunna med- verka och kunna utnyttja dessa resurser krävs också en fortsatt nationell investering i våra unika infrastrukturresurser. Ny inriktning på forskningens miljö Translationell forskning handlar om att skapa ett kunskapsflöde mellan grundforskning, klinisk forskning och hälso- och sjukvår- den samt att ta tillvara och utveckla ny kunskap och nya frågeställ- ningar som sjukvården genererar. Allt i syfte att uppnå bästa möj- liga patientnytta. En utveckling där man skapar translationella forskningsmiljöer där forskare med olika grundutbildning och kompetens samverkar är därför nödvändig. Detta kan lättare ske inom ramen för ett gemensamt universitetsmedicinskt centrum där utbildning, forskning och vård är integrerat inom olika ämnes- områden och specialiteter. För att förverkliga åtgärdsförslagen krävs ett årligt resurstillskott från staten med . Utredningen bedömer det inte som möjligt att finansiera insatserna genom befintliga medel inom statsbudgeten eller genom omprioriteringar av dessa. För att förverkliga förslagen om att ombilda universitetssjukhusen samt att skapa en fond för behandlingsforskning krävs därför nya medel. Utredningen har valt att föra fram och prioritera ett begränsat antal förslag av avgörande betydelse för den kliniska forskningen. Det är angeläget att utredningens förslag kan förverkligas . Om inte rekryteringen av unga forskare intensifieras, behandlingsforskningen får stöd och UMC med gemensamt ansvar för utbildning, forskning och sjukvård bildas, hotas kvalitén i hälso- och sjukvården. Eftersom bildandet av UMC med en gemensam ledning är över- ordnad frågan om ägarskap och verksamhetsform, ska förslaget om bolagisering inte ses som en absolut förutsättning för ombildning av universitetssjukhusen till UMC. The Inquiry on began its work in spring . In February 2008 it submitted an interim report entitled Världsklass! Åtgärdsplan för den kliniska forskningen [World class! An action plan for clinical research] (SOU 2008:7). In the interim report, the Inquiry outlined the conditions for clinical research and presented proposals for an action plan. The action plan covers the following areas: quality control and priority setting, recruitment and careers, infrastructure and the health perspective and implementation of research. to Research and Innovation (Government 2008/09:50) utilized several of the Inquirys proposed measures and it is now possible that these will be implemented under the increased funding frameworks allocated to universities and research councils. Several challenges remain if Swedish clinical research, and thus also health and care, is to regain the prominent position we have previously enjoyed. This is especially evident in the inter- national evaluation that the Inquiry conducted jointly with the and the . On the basis of this evaluation, the Inquiry now presents additional propo- sals, which along with the previous action plan, should be viewed as the Inquirys total of measures to strengthen clinical research. The proposals in brief Strengthen the link between education and research and create more positions that combine research and clinical work. () integrating educa- tion, research and health care, under the joint management of local and central government. It is proposed that UMCs pre- ferably operate as limited companies. To close the gap between new research findings in health care and facilitate implementation, a fund for applied clinical research and clinical trials will be established, and a national cooperative group will be formed. Provide increased infrastructure support to facilitate the use of biobanks and health care quality and patient data registers. Tar- get new investments in translational research environments for rapid knowledge transfer. Clinical research is a prerequisite for high-quality health and medi- cal care. It is the link between the laboratory and the patient. The Inquirys definition of the concept of clinical research is based on research that presupposes health care structures and resources and that aims to solve a health problem or identify factors leading to better health. This broad definition includes rather than excludes different types of research activities and reflects a more integrated view of research. Compared with other countries, the quality of Swedish clinical research over the past 10–15 years has declined. Various explana- tions are offered. Research-trained health care professionals point to a lack of time for research, credit and recognition for research and a lack of positions that combine research and care. The business sector points to a shortage of clinical investiga- tors and a declining interest in clinical trials collaborations. The health care authorities highlight the difficulties in providing scope for and implementing research findings in a shrinking economy. The universities call for leadership at the university hospitals/local government that will emphasise and promote research. The challenges facing Swedish clinical research range from the local to the global and can be summarised in the following five points. A new public health perspective is placing new demands on research. is becoming more intense. Demands on health services are marginalising research. High retirement rates are expected among health professionals conducting research. Coopera- tion between health services, academia and industry needs to be improved. research is long-term and thus its success and setbacks do not have an immediate impact on health services or the rest of society. The declining quality of clinical research that we are expe- riencing at present stems from developments over a number of years. is losing a body of knowledge and development potential as a result of retirements and the lack of time for research among younger clinical researchers. To date, these difficulties have been overcome by the commitment and initiatives of individuals. This is untenable in the long run; must use its research and health service facilities to drive development forward and create structural solutions that will provide hope for the future. the years, various measures have been taken to improve conditions for clinical research. However, the most important pro- blems have not been resolved and a sense of resignation is therefore widespread among the country's clinical investigators. It is impor- tant to point out that the situation does not stem from disinterest or ignorance on the part of those in positions of responsibility in the health services and at universities. It is more a matter of the issue being complicated by the involvement of multiple parties having setting different priorities. Current forms of responsibility and funding, and current atti- tudes, no longer work. These need to change if we want clinical research to be characterised by high quality and competitiveness. The incentives for change are obvious. The link between clinical research and good health and care is strong and measures are therefore necessary to ensure that Swedish patients can be guaranteed the best possible care and treatment. Strong and com- petitive pharmaceutical and biotechnology industries are also pre- requisites for this development. In addition, health economics research has found that health-related research is economically effi- cient. A review of the literature highlighting the economic value of research in medicine and related areas shows this to be the case. Preliminary data from also point in the same direction. The problems that have been solved have mainly been solved at the local level through cooperation between county councils and universities. The results have been good and the process important but the steps have been too small. The Inquiry considers that it is now time for some major changes to the system that focus on the issue of responsibility and research funding. In an international perspective, Swedish clinical research has clear competitive advantages: a high proportion of health care professio- nals with research training, assets in the form of health data regi- sters, quality registers and biobanks, patients that are keen to take part in research projects and a stable public health care system. also has a long tradition in the area and for many years cli- nical research has contributed to the strong position that Swedish industry occupies today. All of these factors are competitive advan- tages that many other countries lack. For this reason, Swedish cli- nical research should not be satisfied with being good enough. It has the potential to be at the forefront, which is a prerequisite if we want to develop the best health and care and a strong pharmaceutical and biotech Swedish industry. To provide a broader base for proposals on how to develop clinical research, the Inquiry conducted a joint international evaluation with the and the . Inter- national expert groups has evaluated clinical research at six Swedish and five Finnish universities with faculties. The evaluation groups analysis and proposals concur fully with what the Inquiry has previously identified and focused its measures on. These can be summarised in the following points: weak recruitment and career opportunities for young resear- chers, weak cooperation between health care at university hospitals and faculties, lack of longer-term funding, and of clinical treatment research in particular, develop and exploit our unique infrastructure – biobanks, registers, etc, lack of mobility and internationalisation, and weak innovation systems and cooperation with industry. The Inquiry has chosen to focus on a limited number of proposals for measures that are deemed to be particularly important to help Swedish competitive advantages make their full impact. Central government, local government and the industry are all actors that greatly benefit from clinical research and are therefore jointly responsible for its development and quality. The proposed measures are based on all actors taking this responsibility – not only through a general consistency of views but above all through cooperation. We also consider that increased cooperation between research funding institutions is essential to the gap between research and the implementation of research findings in health care. Several parties are jointly responsible for the implementation and funding of each proposed measure. However, as research is mainly a central government responsibility, the Government has overall responsibility for driving the process. Clinical research in is on the verge of a generational shift. year for the next ten years, 250 clinical investigators will retire. The same is expected in other health professions. To main- tain high-quality health care, research and education, this loss of knowledge and experience must be replaced. The need for researchers is therefore great and rejuvenation of the countrys cli- nical researchers is also necessary. Younger people do not find a research career attractive. It is fundamental for the quality of future research that young academically talented students considering a research career can look forward to good and clear career pro- spects. Business sector representatives regard the lack of new and committed researchers in health and care as the most serious threat to the continued strong development of Swedish industry. The international evaluation points to the need for recruitment measures and several international analyses deem that recruitment and better career opportunities are the two most important measures needed to strengthen clinical research. The interim report proposed investments in research schools, inte- grated specialist and research education and recruitment services for young clinical researchers. The Inquiry now proposes: Stronger link between education and research To recruit young researchers and strengthen the research perspective and for renewal in the health service, research needs to be given a clearer role in education, both in undergraduate programmes and specialist and further training. Educational positions at university hos- pitals should be more clearly research-related than is the case today. The faculties and health care authorities must together extend their investments in positions that include both research and clinical work. It must also be possible for researchers with biomedical and other undergraduate education to obtain research positions in clinical research programmes. At university hospital with a joint responsibility for research and health care, the leadership should have experience of both research and clinical work. University hospitals – the hub for clinical research The university hospitals are responsible for providing health care and conducting research and education. than 90 per cent of all clinical research originates from university hospitals. They offer a hospital environment with access to research-trained staff, proxi- mity to academia, patients, patient data and advanced equipment. This research includes research activities at other institu- tions with links to universities and university hospitals. The university hospitals provide health care at all levels and account for more than 30 per cent of health and care. This means that university hospitals are very large and hard- to-manage health care organisations. to their extensive remit to provide health and care, university hospitals today are perceived and run more like regional hospitals with responsibility for advanced and highly specialised care. Health and care, and research and education at university hospitals must be managed in an integrated way. Todays university hospitals have no clear research mandate that is integrated into their operations, and research has to take a back seat to short-term health care demands for efficiency. The problems stem from dual ownership for university hospital operations. This gap must be closed. The Inquiry identifies several threats to the research that is intended to be conducted at university hospitals. Lack of time for research is the main problem. This means that research clinics will not be allowed time to do research and health and care will not be prepared to conduct clinical studies. The lack of research staff means that the major research investments now allocated to universities and strategic research areas cannot be used, and will not have a full impact on health care. The starting point for our proposals is improving the for university hospitals to carry out their research and health care tasks in an integrated way. The proposals aim to sharpen the research focus and thereby raise the quality of both research and health and care. To integrate health care, research and education operations, the Inquiry proposes that university hospitals in county councils and regions with faculties reorganise into six (UMCs). Taking into account the conditions of each region, a UMC should have a more limited health care remit than existing university hospitals. This will enable cooperation between health care, research and education to be more effective. At the same time, UMCs must undertake regional cooperation in education and research and serve as regional knowledge centres and nodes for knowledge transfer and cooperation. Unlike the present organisation, a UMC is a coherent organisa- tion under one management with joint responsibility for the three tasks. The university hospitals today are run by two parallel organi- sations, the county council and faculty, with different stra- tegies and planning horizons. A UMC under one common management assigns research a clear place in the organisation and health care and its needs will serve as the driving force for research. A common organisation will not dissociate clinical research from health care. It will create opportunities to develop transla- tional research environments that enhance cooperation and make recruiting young clinical researchers easier. With more efficient knowledge flows, research findings can be implemented more quickly in health and care. In addition, a coherent UMC will be an attractive cooperation partner for external and industry. This will strengthen the innovation process and enable effective use of research results in health care. Research activities at UMCs will be expected to increase, and follo- wing the monitoring and evaluation of their tasks and objecttives this will warrant the allocation of research resources by central govern- ment. At present central government allocates funds amounting to billion to county councils and their university hospitals. To enhance the quality of research at UMC research funding must increase. The Inquiry considers that an increase of million is realistic when all the UMCs have been established. The Inquiry has considered various models of how a UMC should be governed and organised. Regardless of the choice of operational structure or who is the owner, the overall objective must be that county councils and central government together create UMCs that function as a hub not only for clinical research but above all for know- ledge-driven health care. The legal form of Effective cooperation in research and education already exists between the partners but there is to indicate that, within the framework of the current activities, efforts are being made to expand cooperation to cover the entire remit. The Inquiry there- fore considers that the very extensive cooperation required to create and run a UMC demands a more robust structure than todays management as government authorities. The Inquiry proposes that county councils and central government preferably together, in each county council/region, esta- blish as limited companies. The proposal means that what is today referred to as a university hospital will go from being an entity under administrative law to being a limited com- pany with the central government and county councils as part owners. The Inquiry has also examined other models for governance and found that research would not be guaranteed by central govern- ment ownership either, since the primary activity is still health care. It has also considered whether UMCs could operate as foundations. The main disadvantage is that a foundation is an inflexible and rigid organisation. From the research point of view, a county council-owned UMC run as a limited company does not differ significantly from the current organisation and is not parti- cularly likely to guarantee the role of research. The responsibility for UMCs – if run as limited companies – and their entire remit would automatically be that of its board and management. Through the board and executive management, the company would be given full responsibility for planning, gover- nance and operation of UMCs.