sou · GXB355 · 2009-06-10 00:00:00 — skall som expertmyndighet följa och analysera det epidemiologiska läget nationellt och internationellt och föreslå åtgärder för att landets smittskydd skall fungera effektivt. 8 § Varje landsting ansvarar för att behövliga smittskyddsåtgärder vid- tas inom landstingsområdet, i den mån annat inte följer av denna lag. Vad som sägs i denna lag om landsting gäller också en kommun som inte ingår i ett landsting. 9 § I varje landsting skall det finnas en smittskyddsläkare. En smittskyddsläkare utses av en sådan nämnd som avses i 10 § hälso- och sjukvårdslagen (1982:763). I frågor som inte gäller smitt- skyddsläkarens myndighetsutövning skall denne verka under nämn- den. Smittskyddsläkaren får uppdra åt en erfaren läkare vid en smitt- skyddsenhet eller vid en infektionsklinik inom att fullgöra uppgifter som smittskyddsläkaren har enligt denna lag. detailed description of the tasks is given in the document Förordning (2007:1215) med instruktion för . It states that SMI must follow the epidemiological situation of communicable diseases among people and promote protection against such diseases. In particular, it must follow and analyse the epidemiological situation and protection against comminicable diseases, nationally and internationally, provide information about this to () and other relevant bodies and propose necessary measures, follow and analyse immunity in selected population groups following vaccinations and make proposals concerning vaccina- tion interventions, make initiatives that promote protection against communicable diseases also during crisis and war conditions, maintain competence to make diagnostic investigations of rare diseases contributing to the national protection against commu- nicable diseases, maintain relevant sample depository of bacteria, viruses and other similar agents take responsibility of supporting the quality of labora- tories working in the field of diagnostics of communicable diseases conduct research, development of methodology and training within the field, participate in the international collaboration within the field follow and analyse the development concerning hospital infec- tions and antimicrobial resistance and make proposals for inter- ventions for . Even if detailed, the list does not indicate to what extent research should be implemented in fulfilling the above mentioned tasks. In general, it may be stated that in order to accomplish any of the tasks, high quality research is an essential prerequisite. The extent to which the research is relevant for this varies by time and situation. In general, a broad basis with strong input from basic biological research is the prerequisite for the best possible response in emerging situations. SMI has a central role in the surveillance of communicable diseases both nationally and internationally as an expert authority. SMI is the only governmental institute or body in the field that is tasked with scientific research relevant to infection control. It is the institute to give scientific support to other authorities in their actions against the threat due to communicable diseases. However, in the report Rapportering av regeringsuppdraget Strategiskt viktiga frågor inom det nationella smittskyddet by does not seem to have any special role that would reflect its national status: it is stated to run the data collec- tion by maintaining the national SmiNet surveillance system, but in the infection control work, the main responsibility seems to be on the regional authorities (, infectious disease doctors). In the legislation concerning response to IHR (Inter- national Health Regulations, WHO 2005), most of the responsibi- lities are allocated elsewhere. However, SMI is in a key position as a national and international expert having special facilities to iden- tify and analyse agents that may pose emerging threats relevant to IHR. In a critical situation international contacts directly between experts and expert laboratories are often of great importance, emphasizing further the role of SMI. When compared to similar institutes in other European coun- tries, the tasks mostly allotted to such organisations include: Surveillance and national data collection. This may include deve- lopment of case definitions, maintenance and support of natio- nal reference laboratories, analysis and information. Case and outbreak detection (sometimes called epidemic intelli- gence). Through surveillance, a central institute is often the first to receive information on suspected cases of emerging infec- tious diseases. It can promote case and outbreak finding by in- forming and training of people responsible for primary dia- gnostics of communicable diseases and provide special techno- logies and resources for rare, difficult to diagnose, diseases. It can support outbreak findings through outbreak investigations and data collection and analysis. Support to microbiological laboratories. A central research institute is in a key position to provide information and even technical support such as special diagnostic tools to routine microbiological laboratories. It can also have a role in coordina- ting a necessary surge capacity in case of large outbreaks. It has an important role in identifying trends and observations that may be relevant for nationwide response. Public health interventions. A central national institute has a key role in planning and analysing the impact of nationwide interventions such as vaccinations and vaccine policies. A national institute has an important role in suppor- ting and executing research in relevant fields to support its other functions in infectious disease prevention and control. Academic institutions often have other interests than public health leaving important sectors into a shadow. High level research also contributes to the of competent specia- lists into the field of public health. 3Comparison of SMI to corresponding institutes in the neighbouring countries SMI has a long tradition of sound scientific research work with high impact. It has undoubtedly helped in the recruitment of skillful scientists and, through them, opened a productive access to external funding. The link with academic world and KI in particular has been instrumental in providing wide basis for practical and intellectual resources. Planned collaboration between the Centrum for Folkhälsa (CFF) in province and KIs KFA (health of KI) may further strengthen the research basis available for SMI. As a result, SMI has a high quality and wide scientific portfolio reflecting to some degree academic freedom in priorities and work contents. At the same time, some of the research very nicely supports the everyday tasks that SMI has to its stakeholders, the board and the local infection control departments. Compared to its neighbouring countries, , and , the closest resemblance is with SSI in where also an accredited institute is responsible for infection control with only a few other duties in the field of Public Health. In and , the institutes that correspond to SMI are part of pub- lic health institutes with wider range of duties from environmental monitoring, surveillance of non-communicable diseases, health promotion, epidemiological research to surveillance and control of communicable diseases. Concerning the Danish institute loca- ted in it is a larger institute with 1 198 employes (2007) and with a turnover of 1,128 mio. DKr (150 mio. ), but its tasks also include prevention of congenital diseases in addition to communicable diseases like SMI, and, SSI has still a large commer- cial production of vaccines and substrates for microbiology and serology (culture substrates, diagnostic kits etc.) which is also ex- ported to other countries (). The commercial part of SSIs turnover is as follows: Diagnostics on samples submitted from pa- tients: , vaccines: , diagnostica: . SSIs total revenue was in 2007. The purpose of SSI is to prevent and combat communicable diseases, congenital diseases and biological threats. SSI is a state institute belonging to the (Ministeriet for Sundhed og Forebyggelse) which is also respon- sible for the and a few other institutions. SSI gets money from the state and from selling its diagnostics (88.4 mio DKr), vaccines (573.1 mio DKr) and diagnostic services (278.7 mio DKr), the number of diagnostic tests (627,000) is manyfold compared to SMI. SSI is chaired by a Director (a doctor, ) and is divided in 3 sections each headed by a sector director: 1. Epidemiology section (5 departments: Epidemiology, Biosafety and biological preparedness, Epidemiological research, in , Bio- and databank); 2. Microbiology and Diagnostics section (6 departments: Diagnostic service, Antibiotic resistance and hospital hygiene, Bacteriology-mycology and parasitology, Diagnostica, Clinical biochemistry and immunology, Virology); 3. Vaccine section (9 departments: and Business developement, Analyse and control, Infection-immunology, Vaccine development, Registration of drugs/vaccines and information, Produc- tion divided into dpts. of Bacterial vaccines, Konfectioning (konfektionering – making ready), Virusvaccines . The major research area of SSI is Epidemiology, Vaccines, Resistance to antibiotics and consumption of antibiotics, Bio- chemical and genetic markers. SSI has made a self-evaluation of their research (impact factors and citations and comparison with other institutions was done by the Danish Technical Knowledge- Center at ) which shows an impact factor of 6.6 (1116 articles) during a 5-year period (2003–07), which is lower than the comparable institutes in (SMI: 7.7– 687 articles) and (KTL: 7.4–2989 articles) but above (FHI: 5.5–956 articles). Measured in that way their research on vaccine and epidemiology are the most prominent areas and the 2 scientists with highest H-factor are epidemiologist and TB-vaccine scientist . (The high level of epidemiology research in SSI could be noted, perhaps future deeper cooperation between SSI and the other epidemiological research institutions in the Nordic countries including SMI is warranted.) The total number of published articles in 2007 was 359 and 323 were in peer-reviewed journals. The mean number of published ar- ticles per scientist was 2.1. SSI produced 1 Dr.Med. Scient, 14 PhDs and 23 degrees in 2007. In 2007 SSI attracted external funds for research: 86.1 mio. DKr (11.5 mio. SSI houses 15 na- tional and international centers and is a part of 50 centers and or- ganisations. In 2007 SSI introduced 28 new or modified diagnostic methods and submitted 4 patents. The whole rapport in Danish can be found on . SMI compares very well with its sister-institution in , the (). Overall, the research of SSI covers the same areas as SMIs research with a few SSI areas being stronger and more maybe weaker – depending on the qualifications of the individual leading scientists. SSI does not have the same joint professorships with the universities in (because the uni- versities are not interested), but they have a few adjunct professors – without salary or any obligations from the universities, and they have much external scientific cooperation with universities as is the case with SMI and KI. However, SSI has a much better involve- ment with the clinical microbiology laboratories in , since 1) SSI has until now its own diagnostic laboratories for all the ma- jor areas of microbiology, 2) is referal laboratory for concerning special pathogens like M. tuberculosis, Salmonella, S. aureus, etc. 3) all Danish specialists in clinical microbiology shall until now spend 2 and now reduced to 1 year at SSI as a part of their training for specialist competence in clinical microbiology. That means that there is a mutual personal knowledge of the colleagues at SSI and of the peripheral clinical microbiology de- partments and of their individual competence. Therefore, the co- operation continues without any major problems. , KTL (Since 1.1 2009 THL): In the infection control is part of the activities of (former KTL, since 1.1. 2009, , THL). KTL has activities such as mental health, nutrition, epidemiology, non-communicable diseases, molecular genetics, environment etc. Departments involved in infection control cover bacteriology, virology and immunology, vaccinology and infectious disease epidemiology. The total number of people working in KTL was about 1 300 of which about 350 worked for microbiology and infection control. Collaboration with universities is not as formally organised as in SMI, but recently professorships funded by external sources have been established with shared responsibilities. An example is a 5-year professorship funded mainly by projects related to HPV vaccination studies. (In some other fields the contacts are much closer, for instance the laboratory for molecular genetics is located inside the premises of the ). Microbiological laboratories in KTL are national reference centers for many infectious diseases and the institute is also the national expert authority in the process of licensing diagnostic microbiological laboratories (public and pri- vate) in the country. The department of infectious disease epidemiology maintains the national registry for communicable diseases. Information is collected online from diagnostic laboratories. It also coordinates surveillance of hospital infections through a network of voluntary participants. It supports training of professionals with particular emphasis on outbreak investigation methodology. Outbreak inves- tigations are in most cases implemented in collaboration with in- fectious disease specialists and clinical microbiology laboratories in the hospitals. The department has slots for infectious disease specialists and veterinarians, usually on a short-term (half-to one year) basis. As a result, a collaborating network of infectious disease specialists in the hospitals, local veterinarians working in public health and the department has been established. In the field of infectious diseases, the research profile in various departments has been shaped by eminent individual scientists. However, annual retreats are organised to shape common policies and strategies and to enhance collaboration between the depart- ments. A national council for communicable diseases is working under the Ministry but it rarely discusses research issues. search at KTL, both what comes to volume and quality is compa- rable to that in SMI. An evaluation of research activities in KTL was completed by an international panel recently (2007–2008). The evaluators pointed out especially the good potential that lies in research that utilizes various national registries, a source of information which is avai- lable only in few countries at the same level of details. Also basic research in particular within bacteriology was appreciated. Research related to infectious disease epidemiology such as research on hos- pital infections, food borne infections, outbreak investigations and data collection (infectious disease registry) were also praised. Financing for research is coming in part from the budget, in part from the Ministry (as short term project funding) and in part from external sources (about one third). FHI (Folkehelseinstituttet, ) The Division of Infectious Disease Control of the FHI has some 200 employees and has a clear mandate in the on Communi- cable Disease Control § 7.9, namely to conduct surveillance and research and provide advice in the area of infectious disease pre- vention and control. The division runs the national surveillance system MSIS, the national outbreak warning system Vesuv, the national surveillance system for hospital-acquired infections NOIS and most national reference laboratories, which also by law feed data into MSIS. (The division does not receive samples for primary diagnostics.) The division is competent body for ECDC in all matters, and it is the national focal point for both the EU early warning system (EWRS) and the International Health Regulations. Regulatory authority within the field of infectious disease control is at the Directorate of Health (equivalent to ) which has a unit of only 1–2 persons in the field and therefore relies heavily upon NIPH. The research in the division is much less than at SMI and there is much less links with academia, with two-three researchers hol- ding posts as professors at the , some of which are financed by the institute. The division produces some 2– 3 PhDs and 4–5 degrees per year. In the division, there is a rather strict prioritisation of research projects. Only projects that directly and in a strict sense serve the core tasks of the division, namely surveillance and advice, can be financed by the basic bud- All other kinds of research needs to be financed by external sources, but also these projects need to be within the institutes pri- oritised areas, as determined by the division director. Among the leaders and researchers in the division, there is a strong sense of difference between the research mandate of the division and that of the universities. This means that the individual researchers do not have much freedom to pursue their own research ideas. The research in the division is within applied microbio- logy, epidemiology of infectious diseases and vaccinology. In only a few areas is the research competitive internationally, particularly in meningococcal bacteriology, epidemiology, population genetics and vaccinology, in MLVA typing of enteric pathogens, and in tuberculosis epidemiology. Outbreak investigations are used as basis for epidemiological research, and a research portfolio is being developed in the area of health care associated infections. Most of the research is funded by the basic budget form the . Some projects have received national research funding, but the input of international funding, such as from the EU framework programme, is very low. 4SMI in a changing world: New challenges for infection control a.Response to emerging health threats, IHR and international pressures The new International Health Regulations (IHR) is a binding international instrument for WHOs member states, including . 1a stipulates several capacities that member states need to have in place before 15, 2012. among these are the capacities to detect, notify and respond to events that may be a public health emergency of international concern. , with the strong scientific basis that SMI provides, will have it easier than most other countries to meet with these expectations. The broad spectrum of research activities help to face challenges that are due to microbes with new pathogenic or epidemiological properties for which no ready-made tools are available. hosts (). Actually, ECDC is located only 300 m from . ECDC runs epidemic intelli- gence functions for outbreak detection, it coordinates European networks, including laboratory networks, and it brings together European experts for synthetising evidence for infectious disease control. Through its coordinating functions, ECDC puts more pressure on national institutes. However, it also creates opportuni- ties for the national institutes. When ECDC builds its networks, stimulates research and coordinates international outbreak investi- gations, SMI would seem to be in a favourable position to benefit and to contribute, for instance with its advanced laboratory facili- ties, strong research base and field epidemiology resources. Modern IT technology has greatly facilitated the development of reliable data collection and transfer making it possible to create databanks and registries from various sources without delay. Tech- nical improvements have also had a profound effect on the working methods of microbiological laboratories. Primary diagnostics for case finding is more and more depen- dent on commercially available test kits. This has caused pressure for merging some microbiological diagnostic services to chemistry or biochemistry laboratories to be run in parallel and with the same apparatus as other diagnostic tests. Near-patient testing is beco- ming applicable to several infectious diseases moving the inter- pretation of the test result away from specially trained microbiolo- gists. At the same time, the focus of interest in the microbiological laboratories of big hospitals or university departments is moving out from fields traditionally associated with public health making them less able to perform testing that would for instance be necessary for detecting and analysing linked cases and outbreaks. Also, economic pressures are affecting the situation in an unwanted way for public health: while reimbursement mechanisms are in place to finance studies that are necessary for the microbiological diagnosis of the individual patient, extra money that would be nee- ded for closer characterization of a microbe strain or linking of ca- ses may not be available. Such a development poses challenges to the organisation of public health institutes working in the surveillance and control of infectious diseases. International collaboration, most notably within the framework of EU has facilitated the use and develop- ment of central reference laboratories with recommendations for uniform technology and diagnostic criteria. On the other hand, the national central institutes have been forced to balance between the demands of performing laboratory tests that serve the interest of public health instead of diseased individual and the need for high quality research work in order to meet the requirements for best possible evidence based advice and initiatives. In some countries (i.e. the ) the diagnostic tasks have been outsourced to private laboratories, in some other countries (i.e. ) a net- work of assigned reference laboratories is coordinated nationally to ensure proper collaboration and methodology. At the same time technical development has also given new opportunities for successful public health actions. methods using gene sequencing and other similar techniques have made possible to identify and link clusters of cases with a very short delay facilitating the identification of public health threats in an efficient way. Research has introduced new vaccines for com- mon diseases and are giving hope for developing new successful interventions against such world wide threats as HIV, tuberculosis and malaria. Finally, the increased use of computers have made epidemiological analysis easier and more widely applied helping to identify health risks in a swift way. c.New diseases, climate changes, , immigration, antimicrobial resistance etc. Increased , especially to exotic places, combined with ecolo- gical changes has increased a risk for emerging zoonotic infections that have a potential for world wide spread. At the same time the global seems to affect the biotopes of several zoonotic infections. As a result, disease may spread to new locations. Im- migration changes the disease pattern and risk factors in the society, as do increased imports of food. Antimicrobial resistance is spreading easily not only within a society but also from one coun- try to another. New developments in the EU will facilitate cross border hospital treatment, which may possibly lead to wider spread of resistant microbes to . All these threats pose challenges for public health that cannot be addressed sufficiently without high level scientific research and expertise. SMI has long traditions in contributing to the scientific and practical basis for public health work in the context of communi- cable diseases. It has several internationally highly esteemed scien- tists whose research has received world wide acknowledgement. Good examples from recent achievements should include the development of HIV vaccines, work on tuberculosis, S. pneumonia and H. pylori just to mention a few.