sou · GXB355 · 2009-06-10 00:00:00 — A clearly-stated body of regulations that demar- cates the interface between national responsibility and care- provider responsibility must be developed. The state must shoulder its responsibility and economic incentives must be provided to support efficient and effective communicable disease control activities. Equality of importance must be strengthened, consequently supervision and normative activities are essential. Other stated include that the government agency provides advice and support as well as high quality routines in order to demon- best practice. A central government agency is also necessary to advance issues within competence development and competence management in the sector. In addition to these requirements, strong broadly-based competence is essential for cooperation within EU and other international contexts. Vulnerability is currently at a high level in this area as only a few individuals are involved here. Research that is currently underway at should be changed as concerns both scoope and content as well as the forms under which it is imple- mented. Its long term organisational collaboration with has been extremely successful and has well fulfilled the goals established when was first formed. This success should provide a basis for continued development. Consequently, I regard it as an urgent matter that the research that is normally undertaken within a university be transferred to this university in order to maintain its good standing. The strong research profile achieved by may have led to its other government authority tasks taking a back seat. Given the fact that the develop- ment of communicable disease control issues has become increase- ingly internationalised and given the strong role of epidemiology, new priorities are needed in which these issues come to the fore. Research is necessary and essential but its aim must be to support SMIs primary tasks and the forms in which this is to be done must be carefully considered in collaboration with everyone involved. The level of ambition and design of the countrys immunological monitoring must be discussed using a collaborative approach. Ambi- guity concerning responsibility for vaccines at national government agency level must be removed. The Commissions terms of reference pay special attention to information issues. In my opinion there are both implemented in a relatively ambitious by both government agencies. Which level ambition is the correct one to adopt in relationship to county councils and government agencies working with societal protection and emergency preparedness must be established. Here there are opportunities for streamlining operations. Emergency preparedness issues have become a central element of communicable disease control and, consequently, I consider that this must be a primary task for government agency level. currently possesses a high level of capacity as concerns secure laboratories and these must continue to be a central part of the government agency. The question is whether the emergency preparedness demands for labora- tory capacity allow collaboration opportunities with other sectors within the country and within EU. All together, the problem analysis leads to the necessity for clarifying the division of responsibility between three government agencies. These agencies are , and . I would like to make this change by refining their roles and generally on the strengths each of them possesses. Consequently, research that is sufficiently qualified to belong in a university should be transferred there. This is no unconditional principle, but a primary course in accordance with the applicable guidelines. Exceptions must be motivated specially. I can see that there may be reasons for running communicable disease control research at government agency level, however in other forms than are used today. Government agencies should be clearly tasked with assignments that do not mean they have to assume incompatible roles. Conse- quently the combination of operations under the auspices of is not suitable. The decentra- lised model currently prevailing for communicable disease control must mean institutionalised collaboration between regional communi- cable disease control and national government agency level. A new communicable disease control government agency that is assigned the overall responsibility for communicable disease control with the exception of supervision and normative activities would fulfil these needs. Such a government agency must be assigned a clearly- stated collaborative profile and act in a supportive in its contacts with the professional level in the county councils and muni- cipalities who need advice and assistance in their everyday operations and in times of crisis. The government agency must possess com- petence of sufficient breadth and depth that is required now and in the future in order to be able to manage communicable disease control issues nationally and internationally. This should be an administrative government agency possessing the requisite compe- tence to be able to provide the Government Offices and others involved with the information they need within their specific fields. Research issues should be assigned a clearly-defined role in such a new government agency. They must continue to be regarded as an essential part of communicable disease control, but should support the primary tasks of the government agency. A proposal concerning a new government agency – the Guiding my proposals concerning changes to allocation of respon- sibilities has been the need to create good preconditions for this government agency to be able to deal with the challenges that are inherent in communicable disease control activities today and in the future. In consideration of this, the government agency respon- sible needs a broad, clearly-defined and cohesive terms of reference that are easy to understand by everyone working within communi- cable disease control in the country and that fulfils their need for government agency support. Against this background I propose that a new government agency be established – the . Its primary task is epidemiological moni- toring and analysis within the communicable disease control area. This requires high levels of competence in the field and especially within infection epidemiology. I also see the necessity of moving laboratory operations closer to the epidemiological task in order to achieve improved collaboration between these organisational ele- ments. In my assessment this task also requires the contributions of competences such as statisticians, behavioural scientists, legal advisers and vets etc. In addition to its epidemiological analysis task, this government agency will also prioritise register analysis and register quality within communicable disease control applying the wider content concept that has been adopted during the last few years. The new government agency must be assigned a clearly-defined task as concerns national responsibility for laboratory issues in the communicable disease control area for human communicable disease control. This responsibility includes designing a system of national reference laboratories for certain diagnoses. I propose that this government agency should establish an . This will facilitate collaboration concerning labora- tory issues with those responsible within communicable disease control at county council level and within other important sectors such as animal communicable disease control or responsibility for emergency preparedness matters. In addition the agency will bear a clearly-defined responsibility for vaccine issues and be responsible for monitoring the immunity situation. must be regarded as the government agency that possesses the overall competence within the communicable disease control area. Consequently I would also place responsibility for collaboration within EU and for international collaboration at government agency level here too. From this follows the responsibility for acting as a contact point for IHR at government agency level. In addition, I propose that responsibility for the central be placed at this government agency. I feel that this will streamline operations and simplify contacts within communicable disease control nationally and internationally. I also consider that the increased demands imposed by these tasks now and in the future will receive a better response if all tasks are located in a cohesive government agency for communicable disease control issues, as compared to the current situation where responsibility is shared. The new government agency will be called the in order to emphasise that it is an admini- strative government agency that is to possess administrative and management competence whose stated task is to provide the government, and other government agencies concerned with good quality knowledge and underlying information for decision making that responds to their needs. will carry out its own research and development activities as support for its central tasks. It will also cooperate with universities in the country and outside within the communicable disease control field. I also pro- pose that an advisory council be established to participate in the preparation of a multi-year strategy for research within this field. This council will contribute increased legitimacy and relevance to operative level research needs. This strategy will also stipulate regulations for external financing. I also propose that the close, organisational cooperation currently underway between and should cease in its present form. Consequently, the Donation Professorships will transferred to . I also propose that the research projects whose character is such that they fit better within the framework of a university such as are also transferred there. It is important that research within communicable disease control continues to be provided with good preconditions for success; however this should be done within the framework of university research in order to move more into line with the regulations applying to what is termed sector research. will also continue to collaborate with universities as concerns research and development. Here I also see opportunities for broader collaboration with more universities both inside and outside . However, I am anxious that my pro- posals in this field are not to be interpreted as some negative evaluation of current research as such – quite the opposite, success- ful communicable disease control activities need access to good research results and this new government agency will also carry out research as this competence is essential and valuable. However, given the new terms of reference of , all the research currently underway at cannot be justified. Responsibilities of for communicable disease control issues refined. I propose that role is to be refined into them retaining all responsibility for supervision and normative activities within the area of the Communicable It is proposed that the tasks currently carried out by this government agency that are of a promotional character as exemplified by development issues and the difficult-to-define coordination responsibility should be moved to the new Communi- cable . will consequently be allocated a more clearly-defined role based on its national responsibility for health care and services connected to the area. plays a clear, national role as a supervision and normative government agency within health care and services and there are advantages in placing supervision and normative activities for communicable disease control within the same organisation as activities are aimed at county council health care and services officials and communicable disease control doctors. Responsibility for patient security is not affected by my proposals but remain with this government agency, consequently issues concerning care hygiene are managed within fares responsibility for supervision and health and care. Emergency preparedness issues regulated according to the new Principle of Responsibility mean that the will take over this responsibility for the issues they normally work with on a day-to-day basis. does, however, bear the overall responsibility for planning as concerns crisis preparedness issues and in my assessment this responsibility is not affected by my proposals as concerns the but remain untouched. My proposals primarily affect the Communicable Dis- ease Prevention and Control Unit at plus the National Coordination of HIV/STI Prevention Unit and the operations within their responsibility which should be transferred to the together with the staffing resources necessary for these tasks. The refining of roles I propose for these government agencies is based on the needs depiction previously given in this report. The total responsibility of the will lead to improved efficiency and create space for movement in the necessary direction given the current developments in com- municable disease control issues, nationally and globally. The operations currently implemented by STRAMA (the for Rational Use of Antibiotics and Decreased Antibiotics Resistance) will be moved into the new line organisation. One important reason for doing this is that resistance to anti- biotics is a problem that is here to stay and consequently will be an important part of communicable disease control activities for a long time into the future. In addition I consider that the Com- municable with its new terms of reference and clearly-stated supportive role, as well as close contacts with those responsible for communicable disease control within the county councils, are well qualified to deal with this area. I also assess that STRAMA operations may gain a more stable operations and improved opportunities for development. /STI Prevention will also be transferred from to the . As the decision-making government agency, the must examine issues concerning govern- ment grants aimed at the combat and prevention of HIV/Aids and certain other communicable diseases. It is important to clarify that the work of prevention of spread of STIs and blood-borne diseases is a part of communicable disease control activities and national responsibility should therefore belong to the new . Proposals concerning a new bring with them extensive change in terms of emphases, working tasks and areas of responsibility compared with current operations at SMI. New competence must be brought in, existing competence reduced and other parts should be closed down. Three government agencies are affected by my proposals: , and . Implementation will require extensive efforts as all projects within must be reviewed and compared to the tasks of the new . Several of these changes require legislative amendments and are dependent on decision by Riksdag. to the fact that implementation will require sensitive assessment of ongoing research and that my proposals will affect many employees of government agencies, I consider that implementation issues should be dealt with by an appointed for this purpose. My assessment is that the earliest possible time for the entering into force of my proposals would be 1 2010. lag om ändring i smittskyddslagen (2004:168) Härigenom föreskrivs att 1 kap. 7 §, 2 kap. 5 § och 9 kap. 1 § smittskyddslagen (2004:168) ska ha följande lydelse. ansvarar för samordning av smittskyddet på nationell nivå och skall ta de initiativ som krävs för att upp- rätthålla ett effektivt smittskydd. skall följa och vidareutveckla smittskyddet. analysera det epidemiologiska läget nationellt och internationellt och föreslå åtgärder för att landets smittskydd skall fungera effektivt. ska vaka över och analysera det epidemiologiska läget nationellt och internationellt samt följa, samordna och vidareutveckla smittskyddet i landet. Myndig- heten ska föreslå de åtgärder och ta de initiativ i övrigt som krävs för att landets smittskydd ska fungera effektivt. misstänker eller konstaterar fall misstänker eller konstaterar fall dom skall utan dröjsmål anmäla dom ska utan dröjsmål anmäla det landsting där den anmälande det landsting där den anmälande läkaren har sin yrkesverksamhet läkaren har sin yrkesverksamhet Anmälan ska göras även beträf- beträffande annan sjukdom som fande annan sjukdom som är är eller som misstänks vara eller som misstänks vara smitt- smittsam, om sjukdomen har fått sam, om sjukdomen har fått en inom ett område eller uppträder i inom ett område eller uppträder en elakartad form. i en elakartad form. Anmälningsskyldigheten enligt första stycket första meningen -läkare vid laboratorium som utför mikrobiologisk diagnostik, -den som är ansvarig för ett sådant laboratorium, och -läkare som utför obduktion. har tillsyn över smittskyddet i landet. Vid tillsynen enligt denna lag tilläm- pas bestämmelserna i 6 kap. 9– 17 §§ och 8 kap. 16 § lagen (1998:531) om yrkesverksamhet på hälso- och sjukvårdens om- råde. har tillsyn över smittskyddet. Tillsynen innebär granskning och kontroll av att smittskyddsverksamheten i landet följer riktlinjer och upp- fyller krav enligt denna lag och andra föreskrifter samt beslut som har meddelats med stöd av sådana föreskrifter. Vid tillsynen tillämpas bestämmelserna i 6 kap. 9–17 §§ och 8 kap. 16 § lagen (1998:531) om yrkesverk- samhet på hälso- och 1Senaste lydelse 2004:877. 2Senaste lydelse 2004:877. Denna lag träder i kraft den lag om ändring i lagen (2006:1570) om skydd mot internationella hot mot människors hälsa Härigenom föreskrivs att 5, 10–13 och 16 §§ lagen (2006:1570) om skydd mot internationella hot mot människors hälsa ska ha följande lydelse. för de uppgifter den är skyldig ansvara för de uppgifter den är att fullgöra enligt denna lag eller skyldig att fullgöra enligt denna lag eller enligt föreskrifter som meddelats med stöd av lagen. har meddelats med stöd av Myndigheter, kommuner och och landsting som inom sina internationellt hot mot männi- internationellt hot mot männi- heten om det misstänkta hotet. sen skall innehålla de uppgifter att kunna bedöma om det före- digheten behöver för att kunna bedöma om det föreligger ett mot människors hälsa. internationellt hot mot männi- På begäran skall myndigheter, behöver för att kunna fullgöra sin kunna fullgöra sin informations- åtgärder som har vidtagits och heten om vilka åtgärder som har som kommer att vidtas med stöd vidtagits och som kommer att av denna lag. vidtas med stöd av denna lag. lämna information om åtgärderna till berörda myndigheter, kom- lämna information om åtgärderna muner och landsting. till berörda myndigheter, kom- muner och landsting. skall, om den får information om ett miss- om den får information om ett mot människors hälsa, skynd- tionen om det misstänkta hotet. tionen om det misstänkta hotet. nen har fått information om ett nen har fått information om ett mot människors hälsa i landet mot människors hälsa i landet skall , på begäran skyndsamt och senast inom 24 sationen, skyndsamt och senast lämna information till Världs- läget i landet. muner och landsting. Om det bedöms nödvändigt Om det bedöms nödvändigt för att skydda mot ett interna- för att skydda mot ett interna- ten och andra berörda myndig- kommuner och landsting lämna heter, kommuner och landsting lämna uppgifter till Världs- utländska myndigheter även om även om de är sekretessbelagda sekretesslagen (1980:100). (1980:100). Bestämmelser om skydd mot Bestämmelser om skydd mot kränkning av enskilds personliga kränkning av enskilds personliga integritet genom behandling av personuppgifter finns i person- personuppgifter finns i person- uppgiftslagen (1998:204). (1998:204). landsting får oavsett bestäm- och tredje land för att fullgöra sin för att fullgöra sin uppgifts- Uppgifter som rör någons hälsa får behandlas helt eller Uppgifter som rör någons hälsa delvis automatiserat, om det är får behandlas helt eller delvis nödvändigt för att en myndig- automatiserat, om det är nöd- het, en kommun eller ett lands- vändigt för att en myndighet, en ting skall kunna fullgöra sin kommun eller ett landsting ska kunna fullgöra sin uppgifts- skyldighet enligt denna lag. Om ett område inom eller Om ett område inom eller utom landet har drabbats av ett utom landet har drabbats av ett internationellt hot mot männi- människors hälsa ska Smitt- förklara området vara drabbat av ett sådant hot. Området skall anses vara drabbat till dess förklarar området fritt från hotet. området vara drabbat av ett sådant hot. Området ska anses vara drabbat till dess Smitt- skyddsmyndigheten förklarar om- rådet fritt från hotet. Innan ett fartyg anlöper första svenska hamn eller senast vid ankomsten till hamnen skall befälhavaren på fartyget lämna information om hälsotillståndet ombord till eller om Innan ett fartyg anlöper första svenska hamn eller senast vid ankomsten till hamnen ska befälhavaren på fartyget lämna information om hälsotillståndet ombord till eller om 1.befälhavaren har anledning att anta att smittämnen eller andra ämnen som kan utgöra ett internationellt hot mot människors hälsa finns ombord, 2.fartyget kommer från en hamn i ett område som har förklarats drabbat av ett internationellt hot mot människors hälsa och ankomsten sker inom inkubationstiden för en smittsam sjuk- dom, eller 3.det ombord på fartyget finns en person som har vistats inom ett område som har förklarats drabbat av ett internationellt hot mot människors hälsa att inkubationstiden för en smittsam sjukdom inte har gått ut vid fartygets ankomst till hamnen. information som avses i första information som avses i första sen om innehållet i informatio- fartyg som tillhör och bemannas och bemannas av Försvars- makten ska även generalläkaren Vad som sägs i första och Vad som sägs i första och andra stycket om fartyg och andra stycket om fartyg och Den skyldig- het som befälhavare på luftfartyg har att lämna information enligt första stycket gäller dock endast i förhållande till . Den skyldig- het som befälhavare på luftfartyg har att lämna information enligt första stycket gäller dock endast i förhållande till . Denna lag träder i kraft den förordning om ändring i smittskyddsförordningen (2004:255) Regeringen föreskriver att 6 § smittskyddsförordningen (2004:255) ska ha följande lydelse. fortlöpande sammanställa och ut- fortlöpande sammanställa och ut- värdera anmälningar till institutet värdera anmälningar till myndig- enligt 2 kap. 5 § smittskyddslagen 2 kap. 5 § (2004:168) och på begäran från (2004:168) och på andra myndigheter inom smitt- Institutet skall också med lämpliga mellanrum sända ut information heten ska också med lämpliga mellanrum sända ut information Denna förordning träder i kraft den förordning om ändring i förordningen (2007:156) om skydd mot internationella hot mot människors hälsa Regeringen föreskriver att 5 § förordningen (2007:156) om skydd mot internationella hot mot människors hälsa ska ha följande lydelse. får meddela närmare föreskrifter om -vilka misstänkta eller konstaterade fall av sjukdomar som skall rapporteras till Social- styrelsen enligt 10 § första stycket lagen (2006:1570) om inter- nationella hot mot människors hälsa, och -vilka uppgifter en under- rättelse som avses i 10 § första stycket lagen om skydd mot internationella hot mot männi- skors hälsa skall innehålla. får meddela närmare föreskrifter om -vilka misstänkta eller konstaterade fall av sjukdomar som ska rapporteras till Smitt- skyddsmyndigheten enligt 10 § första stycket lagen (2006:1570) om internationella hot mot människors hälsa, och -vilka uppgifter en under- rättelse som avses i 10 § första stycket lagen om skydd mot internationella hot mot männi- skors hälsa ska innehålla. Denna förordning träder i kraft den förordning om ändring i förordningen (2006:942) om krisberedskap och höjd beredskap Regeringen föreskriver att i bilagan1 till förordningen (2006:942) om krisberedskap och höjd beredskap ordet ska bytas ut mot .