sou · GXB355 · 2009-06-10 00:00:00 — The views and comments I have received from tious Disease Control, and have played a important part in my assessments and proposals. Division of responsibility unclear The division of responsibilities between are unclear at present. This picture, which also is stated in the Commissions terms of reference, has been confirmed during the study. This primarily as a result of the allocation of more broadly based tasks to by changes to the Communicable Diseases Act in 2004. As a result of these changes bears overall responsibility for communicable disease control issues and also the responsibility for coordination - which has not been clearly defined. Neither do the instructions issued to properly define in detail the responsibilities for communicable disease control issues carried by the Board. Neither are clear instructions given as concerns their relationship to . has later been appointed as contact point for the WHO. This task includes responsi- bility for the implementation of international measures as stated in International Health Regulations (IHR). This is an extensive task for the Board against the background of the decentralised responsibility that county councils and municipalities bear for the management of communicable disease control issues. The coordi- nation task has been interpreted as operative by in connection with these tasks and other government assignments as concerns emergency preparedness for pandemics etc. This more operative and development-oriented role risks coming into conflict with the Boards supervision and norma- tive responsibilities covering the same issues. This ambiguity has led to double reporting to just to be on the safe side. It is also worth mentioning here that, while the efforts makes, are appreciated, criticism primarily concerns the combination of incompa- tible tasks that the design of the Communicable Diseases Act has led to. Another area where the division of responsibilities between the government agencies is perceived as ambiguous, is vaccine issues. is the expert government agency but in its instructions the responsibility for vaccine issues is not clearly formulated. Its epidemiological moni- toring responsibility also includes monitoring the immunity situation of the population and proposing any necessary measures. , indisputably, also bears responsibility for vaccine issues, for example through its child vaccination programme. In the vaccine field the county councils and municipalities also need more qualified support from govern- ment agencies. How responsibility for vaccine and vaccination issues is to be distributed is another task of this Commission, the require- ments to be placed on the decision-making process as concerns these issues are currently under the microscope of the Vaccine Commission who will present their proposals in 2010.2 Epidemiological monitoring is a primary task of the Swedish Insti- tute for Infectious Disease Control and results of these activities must rapidly be fed back to the officials concerned in the county councils. Today there is no overall picture of the epidemiological situation that is action-oriented and designed as underlying material for knowledge and decision-making in possible political decisions that may be predicated on its content. Both the officials responsible at the county councils and the Government Offices state the need for strengthening of epidemio- logical monitoring. A well-functioning monitoring system at national level with well-developed international links is essential. Effective and efficient monitoring systems based on a smooth reporting system with good analysis opportunities are clear demands that the current organisational form cannot live up to. Contacts between the central, state level and county councils communicable disease control units at regional level have to be based on established contact networks and a clear division of responsibilities. 2 Vaccine Commission /Dir. research is requested, i.e. such research that is generated by the epidemiological monitoring task. Consequently research based on epidemiology needs to be strengthened. The relevant officials within the county councils are concerned by the development of the epidemiological operations within . the last few years it has lost important competence which has not been re- placed. Other operations within the Institute, which cooperate on epidemiological issues, are not able to fill these needs. New competence in the form of statisticians, behavioural scientists, IT experts etc. must be included in the work within the epide- miological field. This is also confirmed by the observations of the peer review study and by the Commissions own surveying activities. The development of communicable disease control con- cepts also from an international perspective shows that epidemio- logical issues are central. In some cases, this has also led to organi- sational solutions that bring epidemiology closer to the laboratory elements in order to provide them with greater weight. Increasing threats from zoonoses need to be focussed on. Veterinary compe- tence must be added in order to enhance monitoring and analytical capacity. cooperation between government agencies at national level and between regions is necessary in this field. Responsibility for laboratories unclear A common view of both county council representatives is that responsi- bility for national laboratory operations in the communicable disease control area need clarifying. In addition, demarcation between what is a national communicable disease control responsibility as regards care provision responsibility also needs clarifying. Cur- rently, a certain amount of laboratory tests and analyses are carried out, by the regional laboratories on demand of the government agency. Financial compensation in the form of state funding, how- ever, is not given. There is a risk that shrinking financial frame- works will mean that such testing etc. will not be able to be carried out in the future by these laboratories. has described to this Commission how this is already occurring today. This may affect opportunities to operate efficient and effective communicable disease control. Regulations currently governing laboratory operations were established in another time when there were other needs. During the course of this Commission, I have concluded that it is now time to clarify the responsibilities that a national laboratory for human communicable disease control will have in the future. One deficiency in current regulations is that is not able to undertake routine dia- gnostics, not even for its own competence development. Such con- straints need removing, so that laboratory competence may be developed in line with existing needs. It is also clear that interplay can be developed both within and outside these organisations as concerns laboratory activities in the communicable disease control field. This also applies to the inter- play between different sectors such as human communicable disease control and animal communicable disease control. There is also a considerable need to institutionalise cooperation between the national government agencies and the operative com- municable disease control as concerns laboratory issues. Further- more, technical developments have progressed so much that the capacity of regional and local laboratories is well developed in the communicable disease control area. In the laboratory field there are also good opportunities to collaborate internationally which are not fully utilised. Within the framework of collaboration with communicable disease control agency, ECDC, a national communicable disease control government agency with the laboratory facilities that has at its disposal could play an increasingly role in the future.3 Methodological development is a field in which the quality of various commercially developed methods needs to be implemented by national government agencies and this is also an area for international collaboration. In order to be able to answer certain of the questions included in the Commission Directive concerning the research currently under- way at , three internationally recognised researchers were asked to examine the Institutes research.4 Their assignment was firstly to assess the relevance of the research undertaken by in relationship to the primary tasks of the Institute such as epidemiology. Secondly they were to give their views on the quality of this research and assess available laboratory capacity and its role as concerns research emphasis and results. Thirdly they were to express their opinion on whether there is urgent research that would need strengthening at the Institute. Finally these experts were to also assess research covering all these issues in relation to the equivalent government agencies in some other countries. The observations and conclusions stated in the report are these researchers own and they are unanimous. In their overall evaluation is stated, that this research maintains a high quality level throughout. Within some of the areas the research is also top class from an international perspective. This high level of research quality has been an asset as concerns oppor- tunities to be able to finance it with external funding. This is also the case as concerns recruiting top-level scientists. Within certain areas, however, there are some problems that the evaluators have been able to identify. This especially applies to research into infection epidemiology. In comparison with other Nordic communicable disease control institutes, is very successful and its research compares well with that of other countries. However the basis of the Institutes operations is narrower than, for example, or where the operations that are the equivalent of the Institutes are organisationally integrated into larger-scale government agencies whose activities cover a number of issues in a broader public health perspective. In this aspect is more similar to its Danish government agency. 4 Their entire report is included as 2. The majority of the research is highly relevant, some of it not only from a national perspective but also from an international view. Research concerning epidemiology, communicable disease con- trol and biostatistics would benefit from coordination with other fields. A closer contact with practical microbiological diagnostics is also recommended. As concerns resource issues it can be observed that SMI and form, also from an international perspective, one of the larger scale centres for communicable disease control research. Their research portfolio is extensive covering everything from molecular biological basic research to studies of interventions/ inputs at national level. Within many areas this is high quality research and within some areas SMIs research is also close to the international front line. These areas include research into HIV vaccine and concerning tuberculosis, helicobacteria and pneumo- coccus. Basic research within immunology and cell biology has decisively opened the door to new scientific discoveries that may improve opportunities to cure various infections. Research that supports both modern laboratory diagnostics and develops molecular diagnostics has been implemented as concerns whooping cough, HIV and intestinal viruses of different kinds. Researchers have access to animal testing facilities at P3 and labora- tories at P4 levels, which widen their opportunities for studies con- cerning new threats such as SARS virus infections or antibiotic-resistant . Research covers all the relevant areas as concerns bacteriology, virology, parasitology and mychology and forms a good in its role as national reference centre, able to provide support and advice to other actors in these areas. However, some research gaps do exist. Monitoring of com- municable diseases is the primary responsibility of the Institute, consequently more operations and resources should be allocated, to for example, studies in the behavioural sciences field. The highly qualified research within a broad, extensive research portfolio does however, to a certain extent, reflect what the evalu- ators termed academic freedom as concerns priorities, research content and emphases. Part of this research does function as support for the Institute in its daily activities aimed at fulfilling its tasks as a government agency which do not fall within the research field. While the Institutes research is of a good quality and eminent throughout, there are certain problems or risks associated with It is true that research and organisation are strengthened by the fact that a considerable proportion of the research is financed via external funding. The latter does, however, according to the experts, present a challenge in that it is difficult to ensure, with such a large proportion of externally financed research, that the research in question is also relevant for the other main tasks of the Institute. One problem is, however, that lacks an established, written research strategy. has to meet the same challenges as its organisations i.e. how best to match up externally financed research – many times the result of the individual interests of researchers and access to research resources – with the requirements of core operations and the priorities of the Institute. The experts indicate several important factors; clear leader- ship, an established research strategy and the commitment of diffe- rent stakeholders. In addition there is a lack of formalised proce- dures aimed at ensuring influence over research and other activities by other Swedish actors within communicable disease control, primarily the county council communicable disease control units. From the very beginning, close cooperation with has formed a vital cornerstone of . Research has also expanded drama- tically since the beginning of this century. is currently one of the diminishing numbers of Swedish government agencies that out its own research. Current collaboration between and means that the research carried out by them is closely integrated. One clear expression of this is the positions as Donation Professor and the conditions associated with these posts. People holding these positions are partially included in the line organi- sation of but are employed by . However, they work part of the time at . It has been clearly demonstrated during the mapping of operations at the responses provided by that there is close collaboration between these two organisations and that this produces good synergy effects. These professors play an important role as concerns applications for external financing for qualified research projects. My conclusion is that there are good reasons for a government agency with responsibility for epidemiological monitoring and national laboratory as its primary task also to carry out research as support for these operations. At the same time, given the current situation, there are clearly problems associated with the combi- nation of the legal authority activities of a government agency with such extensive and expansive research as is carried out at . Research that is, like research operations generally, very dependent on external finan- cing. Consequently research emphases, to a greater degree, are con- trolled by external interests. It is a major challenge with such a large amount of externally-financed research to also ensure that it is relevant to the organisations other government authority tasks. Today there is no established research policy or research strategy at SMI. Examination of research projects is carried out on a continuous basis which means that the issue of externally financed projects may lie outside the scope of traditional budget and operational planning and control if they are dealt with mid-budget year, for example. In this context, government instructions, as of the long-term goals of a government agency, have probably limited force. If accepts external financing for a research project, the Institute debits the research projects in question for overhead costs in accordance with the guidelines established by (). These costs amount to of the grant and exceed SMIs actual administrative costs. As a result, external grants bring opportunities to finance other operations. SMI has been able to utilise these financing opportunities for its expansion since 2000. Another issue concerned with external financing is that SMI has used these funds for its daily operations in spite of the fact, that they cannot be regarded as allocations in the same meaning as government appropriations. Consequently, the organisation is open to the risk of starting up operations which do not receive continued financing which results in vulnerability for strategic operations within the organisation. Internal control is primarily based on the project form as, in prin- ciple, all operations are organised into projects. The only exception is administrative operations. Such extensive and long-term project organisation leads to the fragmentation of operations. Long-term operational goals – and consequently the organisations primary tasks – experience some difficulty – in asserting themselves against these other priorities. The line organisation relationship to the strong prio- rities of research. Long term organisational collaboration between and contributes to operations becoming less transparent. The opportunities presented by external financing to receive grants that exceed actual costs means that they may be prioritised above other activities. Prestige projects, whose external financing does not cover costs means that governments appropri- ation funding, is used for them instead. The primary task – the epidemiological activities – has not been able to assert its own interests in-house. From what this Commission has been able to discover, this situation has not been paid any attention in the government control of the Institute. The Communicable Disease Prevention and Control Unit at appears to be the hub of the communicable disease control activities for the entire government agency and strengthens other parts of the organisation with its knowledge. For example, this unit is responsible for activities within the health care hygiene area as well as issues concerning resistance to antibiotics. According to information received, the Health Care and Department does not participate in these activi- ties. The Communicable Disease Prevention and Control Unit is also assisting with competence for supervision activities. Its coordi- nation tasks appear to include many contacts with the communi- cable disease control organisation within the county councils and information inputs have been prioritized. The broad mandate of , has, according to the Communicable Disease Control Act, and its growing response- bilities within EU as well as for the implementation of the Inter- national Health Regulations, IHR, appear to be totally carried out by this unit within the Board at the same time as it also supports other parts of the organisation with competence in the communi- cable disease control area. Consequently the Communicable Disease Prevention and Control Unit, within the framework of its organi- sation, has to manage as diverse tasks as supervision, normative and development/support inputs as well as coordination and emergency preparedness issues within communicable disease control. The tasks of within communicable disease control – as stated in its government instructions – are ambiguous. The expanded responsibility allocated to the Board by the Act is not clarified in its instructions and the Board has received no clarification of what this responsibility means in practical terms in relationship to responsibilities in this field. has, through its Communicable Disease Prevention and Control Unit, had to interpret its task itself without any more detailed guidance. Traditional administrative tasks such as supervision and norma- tive activities have been the responsibility of for a long period of time while its Communi- cable Disease Prevention and Control Unit was, up until 2003, staffed by a very few people only. Its responsibilities grew with the change in legislation concerning extraordinary events and its new responsibilities according to the protection against International Threats to Human Health Act brought additional issues. Super- vision and normative activities are carried out within the same department, which also deals with follow up and evaluation as well as with the difficult-to-define responsibility for coordination. Development activities also belong to the tasks of this unit. Doctors working within communicable disease control regard this combination of tasks and the operative content of the coordination responsibility as unclear. When this Commission held an initial hearing on the situation, this issue was taken up by some partici- pants. They maintained that , regarding these new tasks, had been assigned roles, which were incompatible with each other. The Communicable Disease Prevention and Control Unit has built up a new competence areas and has expanded rapidly. This has been perceived as both positive by the county council communicable disease control doctors but also as a top-down approach in which they are reduced to suppliers of information but do not get the results fed back into their own everyday operations. It is clear that has been assigned several, serious and time-consuming tasks by govern- ment which have required collaboration both with communicable disease control doctors and with . There are also different approaches to the actual communicable disease control work and what development is required as concerns these two government agencies, differences that are reported openly and that create insecurities among the people who work with communicable disease control issues, which also contribute to the ambiguous picture as far as division of responsibilities is concerned. According to , the current division of responsibility does not cause any duplication of work. does what needs to be undertaken, and what is not done by anyone else. Even so it can be observed that activities within the area of information are carried out by both government agencies and criticism has also been levelled at lack of collaboration as concerns the preparation of pneumococcus vaccinations. It is not easy to assess what this lack of collaboration is due to, but it is experienced as an unnecessary problem by those responsible for communicable disease control. The Communicable Disease Prevention and Control Unit also has received additional tasks connected with cooperation within EU and in other international contexts. The same applies to its increased responsibility for pandemic planning and implementation of IHR. Parts of these operations have been managed thanks to the allocation of additional funding by the government, however this additional help is for a certain period only. This creates vulner- ability and the financing should be changed to a more long-term basis on the grounds that these tasks cannot be regarded as a temporary situation. The needs expressed by county councils and municipalities can be summarised in the fact that a strong government agency is necessary in this field. epidemiological monitoring and analysis that can provide rapid, reliable decisions is their most important require- ment, an opinion echoed by the officials at the Government Offices. Clearly-defined responsibility for laboratory issues concerning human communicable disease control is also an important require- ment from the officials responsible within county councils. This responsibility means developing collaboration both inside and out- side the country.