CONTENTS
2. ECDC: an agency growing in health and strength
3. Szuzanna Jakab does not see a huge expansion in the ECDC's mandate before 2014 - Meanwhile, the centre could have a role to play in the field of rare diseases
6. A crisis operations room for monitoring and controlling health risks
7. Reducing resistance to antibiotics
Improving the fight against vector-borne diseases
8 Improving surveillance of food and water-borne diseases
Agenda
ECDC: an agency growing in health and strength
Installed in a former school for the blind built in 1890, whose architecture has gradually become a logo identifying the agency's documents, the European Centre for Disease Prevention and Control is already beginning to burst its seams, despite only being set up in Stockholm as recently as May 2005. In just over three years, the agency has already recruited a large scientific and technical staff, developed several areas of work, set up a crisis management room and health monitoring and reaction procedures, and published its first epidemiological report. An external assessment to be published on 23 September 2008 welcomes these positive outcomes (see Szuzanna Jakab's comments below).
With a 2008 budget of €41 million, the centre works on infectious diseases and epidemic outbreaks of unknown origin. Its mandate covers communicable diseases and the threat of bioterrorism. Member States have pledged to supply the centre with information about infectious diseases of the respiratory tract (flu, tuberculosis and legionella), sexually transmitted diseases (chlamydia, gonococcal infection, hepatitis B and C, HIV and syphilis), food and waterborne diseases and zoonoses (campylobacteriosis, cryptosporidiosis, infection with enterohaemorrhagic E. coli, norovirus infection, salmonella, hepatitis A and E, listeria, botulism, brucellosis, Creutzfeldt-Jakob Disease and other transmissible spongiform encephalopathies (TSE), shigellosis, toxoplasmosis, trichinellosis, yersiniosis, anthrax, cholera, tularaemia, echinococcosis, giardiasis, leptospirosis), emerging diseases and vector-borne diseases (malaria, Q Fever, chikungunya, Hantaan virus, Dengue fever, yellow fever, West Nile Fever, Lyme disease, tick-borne encephalitis, the plague, severe acute respiratory syndrome (SARS), smallpox, haemorrhagic fever and other emerging diseases), diseases which can be prevented by vaccines (haemophilus influenza B, measles, meningitis, mumps, whooping cough, rubella, pneumococcus, diphtheria, tetanus, poliomyelitis, rotavirus rabies, chicken pox, human papilloma virus) and antibiotic-resistant nosocomial infections.
With a current staff of around 230 (122 of whom are statutory civil servants; the remainder are national experts on secondment, consultants and temporary staff), the centre is expected to employ around 280 by the end of this year. After starting off in 2005 with a budget of just €5 million, the centre reached two-thirds of its full size this year. The Financial Perspectives (the EU's multi-annual budget) foresees a budget of €50 million in 2009 for the centre, rising to €60 million in 2010. Some €18 million of the centre's 2008 budget is earmarked for staff costs, €5 million for buildings and associated costs, €17 million for operational expenditure - network coordination, scientific studies, surveillance, experts and IT - €4 million for training epidemiologists in the field and €2.5 million for communications.
Bang in the heart of the campus of Karolinska University in Solna, just north of the Swedish capital, the ECDC juxtaposes the cream of Swedish medical research. The old 5000 m² building rented from the Swedish state for €1 million a year and renovate at the cost of European taxpayers, can only really house around 180 people but the ECDC workforce is due to rise to around 400 in 2010. To cater for the new requirements, a real estate project will be submitted to the budgetary authority in November 2008. If the European Parliament and the Council of Ministers agree, the centre may be provided in time with a canteen, a conference centre, a 500 m² operations centre with a crisis operations room with some 30 workstations (double the current crisis room) and a press centre for around forty reporters (during the biggest health alert experienced by the centre, reporters had to work in corridors). The finishing touches are being placed on the plans for this 5000 m² extension, which would cost around €20 million or between €1.5 million and €2 million a year under a hire-purchase agreement.
Szuzanna Jakab does not see a huge expansion in the ECDC's mandate before 2014 - Meanwhile, the centre could have a role to play in the field of rare diseases
Szuzanna Jakab is pleased with the work carried out since the European Centre for Disease Prevention and Control was set up. The ECDC Director does not want to abandon her 'baby' but rather to help it grow and gain in strength before considering any change of position. In an interview with EUROPE, she pointed out that an extension to the ECDC's mandate is not possible under the current Financial Perspectives, but with additional budget resources, the ECDC could have a role to play in the field of rare diseases.
Agence Europe: You have been managing the ECDC for three years now. Can you give us your assessment of the work done so far?
Szuzanna Jakab: Quite a lot have been done so far. We have now an agency that is operational. This was not the case three years ago, because we started absolutely from scratch. Now the infrastructures, the tools, the procedures, the strategies are in place and we know what we are expected to do. We have now a long term strategic work plan up to 2013 that is agreed by all the stakeholders - Parliament, Commission, Member States - and the budget which was negotiated with the Commission, the Parliament and the Council. In an institution like ours, the most important asset is of course the technical and scientific staff. We have been recruiting since the beginning and we have been quite successful. We have now excellent scientific and technical staff in place. And finally let me say that we have just finished the first external evaluation of ECDC and it is very positive. It gives me a very good feeling as the director of this Agency that all the expectations of the stakeholders basically are met. What is the feedback of this external evaluation? It says that ECDC brings added value to Europe. It says that in three years we have managed to build scientific credibility and (…) scientific independence and we fill the gap basically in Europe between various institutions. And this is the feedback from all the stakeholders, including Parliament, including Member States and the Commission.
A.E.: What kind of difficulties have you met during these three years and have you overcome them all?
S.J.: We had a lot of difficulties because we had to start from zero. And we didn't have the luxury to start within the Commission where you have everything in place. When you start in a Member State, a host country, where you don't get any support from any side and you have to put in place start the recruitment process, which is not very easy because on the one hand you have to put in place the Staff Regulation, and on the other hand, you have nobody around you. So that was a challenge and I must say that I got a lot of help from the Commission to start. Then you have to find premises for yourself, because you don't have anything when you come here. You just have the thick regulations under your arm, with all the expectations. And here in Stockholm we were fortunate because we found a Mayor, in Solna, which is a small city within the Stockholm municipality, who invited us free of charge to sit in the city hall for six months until we managed to find the building. That helped us with the initial steps. Then in the meantime you have to call for tenders and start renovations and you cannot get subsidies from your own budget unless you have an accountant in place, but you do not have an accountant in place when you start. So this is a vicious circle, you know. They are a lot of these logistical difficulties to solve. The other part of the difficulties was that there are many other public health actors already in Europe, like the Commission with a strong public health programme, the Council taking decisions, the WHO, and you have to build up the programme of your organisation in such a way that it is useful for Europe, that it is useful for your stakeholders, but that there is no overlapping. That's why, when I started, my first priority was to build up partnerships and I'm very happy to say that now the partnerships are OK. We have a really excellent working relationship with the Commission and with the European Parliament. And also, I think that by now I can say that our relations with WHO are also working.
A.E: And with the Member States?
S.J.: And with the Member States, we have three dimensions of collaboration. One is with the Management Board, where you have representatives of the ministries, then my advisory forum where we have representatives of the public health institutions, and then we have the competent bodies in place. We have now 85 competent bodies across the EU and all the Member States. This list was drawn up by the Member States last year, so that started very quickly. By early 2009, all the relationships with all the competent bodies will be in place. We have regular meetings with them. We consult them on our priorities. We find ways for consultations on how to avoid overlapping with what Member States are doing. I think it's working very well.
A.E.: And you don't see some Member States which are more enthusiastic and others more reluctant to cooperate?
S.J.: Yes. The smaller countries which have less capacity, like Cyprus, Slovenia or Estonia, they are ready to take all the advice from ECDC because they don't have to develop their own. And this comes out very clearly from our external evaluation report that 75% of the Member States - which fall into the smaller countries category - are extremely pleased with all the support and all the advice they get. There are one or two bigger Member States with very big public health capacities which need less input from an EU Agency like ECDC. And yet they say that several aspects of our work are useful for them.
A.E.: What are the most important priorities now?
S.J.: During the last three years we gradually started to build up the disease-specific work of ECDC.
And this is what we need now to complete in 2009 and 2010. So I will put the emphasis on specific diseases and in particular prevention. These are those diseases that came out from our first epidemiological report, that create the biggest burden for the European citizens and that have the highest prevalence in the European Union, the first category being the hospital infections and healthcare-associated infections and the antibiotic resistance. That must be an overriding priority for us in the year to come together with the Member States. The second in my list would be the HIV/Aids activities where we haven't managed yet to turn around the trend. Then influenza continues to be a priority, probably less on the pandemic preparedness, although even there we need to finish our work. We still have four or five areas where there is a gap. Our priority would be mainly on the seasonal influenza, where we lose a lot of premature lives. We have really to boost the vaccination rate and we are working closely with the Commission now. We put tuberculosis in the last place in spite of the fact that many people in the EU think that TB is no longer a problem. And it is true that if you look at the trends, TB incidence is slightly decreasing in most of the Member States. But other hand, you have new problems like MDR/XDR TB which have now reached all EU countries. So these are the four main priorities for us. And there are emerging threats, related to climate change for example. We have to pay more attention to it and to put more resources on it and to work with the Member States.
A.E.: A review of the mandate of the ECDC is before us. What changes are you awaiting?
S.J.: For the time being, we only have a mandate for the infectious diseases and for the possible bioterrorism threats, but nothing else. The external evaluation was expected to look into this and they have already come up with some scenarios which need to be further developed. In my view, what has to be done is to review the EU public health programme and to see in which areas ECDC could play an important role to support the EU institutions and the Member States. The initiative and the coordinating role have to be with the European Commission. The Commission knows what they can deliver with the staff they have on board, with DG SANCO, and they have to clarify in which area they would need more capacities. I can only foresee a few areas like monitoring…
But this is just an example, because in my view we need a very serious analysis and to sit down with units of the European Commission and discuss one by one in which areas we could play a role.
And then this exercise has to fit with the new Financial Perspectives of the EU. If additional areas are coming here, then we will also need additional resources. And in my view, this will only be possible with the new Financial Perspectives (in 2014, Ed.). Of course that does not mean that in limited areas where ECDC can play a useful role and if some additional budget can already be assigned to it, we wouldn't take it on board, but I think that a major expansion can only be expected with the new Financial Perspectives.
Then you have also to see if there are any areas in the non-communicable diseases or in the rare diseases, for example, where ECDC could play a leading role and I could easily foresee some areas, but I don't want to speculate on this without a real analytical view and discussion with the European Commission, Member States and the European Parliament.
A.E.: There is, I think, a draft communication on rare diseases, to be adopted by the end of the year, which mentions the possibility of giving a role to ECDC for rare diseases.
S.J.: If the Commission so decides, I would be delighted because I think this a domain in which ECDC could fill a gap in Europe. And it also comes up in the Parliament all the time that there are rare diseases that are not really coordinated. So we will be delighted to do so it if the Commission decides it and gives us some additional resources for it. Of course, there are 3000 rare diseases and we cannot expect to have all this expertise here. But what we can do is to create a database of what are the best institutions, what are the best places in Europe and where the best expertise is available. And this is also closely linked to the directive on cross-border healthcare and the implementing rules because with the implementation of the directive it will be possible for the patient to move from one country to another, which is not the case so far unless your national system decides to send you to another country. This could be a logical next step for ECDC.
A.E.: Do you want to continue your job here or have you other plans?
S.J.: My plan is to stay here. Because if you start to build up an agency like this in an exciting area and with the potential to further develop the mandate into other areas, then of course, you want to see that work finished and finalised. You don't want to leave you baby alone half-way through. I think ECDC is not yet ready. We need three more years to consolidate our current mandate and to deepen the work, and by 2010 we should be ready on every aspect of the communicable diseases, and then be able to take up any new role and task. And I hope, if I have the pleasure to serve here for another mandate, then by the time I leave, ECDC will really be a strong institution. As recently our management board was working on the report on the external evaluation, the Chairman of the Board said his dream is that in twenty years time, ECDC will be as strong an institution as CDC Atlanta is today. ECDC should not only cover communicable diseases but also core public health. And he was very positive, he said: 'If you get all the infrastructure and all the support, this will happen if you maintain the same speed.' So, that is what I want. I want to leave an institution that is really useful for Europe, and this is not the case yet.
A crisis operations room for monitoring and controlling health risks
Set up against the backdrop of globalisation, which has increased the speed at which human beings travel around the world, along with the speed at which products and pathogens circulate, the European Centre for Disease Prevention and Control (ECDC) needed a permanent health monitoring and reaction mechanism in case of a crisis of European dimensions, namely its permanently manned crisis operations room.
"During the day, there are at least two people in the room; someone responsible for logistics and an epidemiologist," explained Dr Denis Coulombier, manager of the rapid reaction unit. The day usually starts with the collection of information. Alongside information from Member States' health authorities (Member States are obliged to give notice of European level alerts using the EWRS system), the WHO and various epidemiological monitoring surveillance networks, ECDC has a computer system for searching for information on the Internet about global health risks. At 11.30 hrs, a conference is held to sift through the mass of data. The information is analysed using a well-oiled model. If there is a sufficiently important European dimension, an alert will be launched, meaning that the case will be continually monitored in detail until the risk dies out or is found to be non-existent. During our visit, Dr Coulombier's team was monitoring on screen the progress of a merchant navy ship sailing from Romania under the Maltese flag. The cargo had been followed for several days through the Bosphorus to its destination, a French port in the Mediterranean. One of the sailors was displaying symptoms of acute tuberculosis, which could have spread to some or all of the remaining crew members from Russia and Central Asia. The Stockholm centre was in contact with the Turkish health authorities who had sent the ill sailor to hospital while awaiting the outcome of tests carried out on him. The centre was also in contact with the French shipping authorities to identify measures that could be taken to test the remaining crew members. Other items on the agenda that day included yellow fever in Brazil; a doubling of the number of cases of malaria (plasmodium vivax) in the Moscow region since 2005 (although the overall numbers remained low); - and a snowballing of cases of Q fever in the Netherlands in 2008 (600 human cases of this sheep zoonose which has the potential risk of various symptoms including neurological problems and miscarriage in pregnant women).
In addition to this minimum daily work, a watch is kept 24/7 and there is a search for incidents three times a day at the weekend. In the case of crisis, there are two levels of crisis alert, "which do not always correlate with the scientific and technical seriousness of the situation; it can simply be media interest or the European dimension". These levels can reinforce the permanent team by calling other people from their offices or outside. Level 2 is the higher level for a crisis, requiring continuous team work 24/7. The room itself contains a dozen workstations but the rest of the centre can be linked up to help manage a large-scale crisis. In fact, some 60% to 70% of the centre's staff could be assigned to such the crisis. Some 20% to 25% of the centre's staff carry out core functions that cannot be interrupted (crisis management must not prevent the normal monitoring work that would enable further crises to be detected). These core functions are being set out in a new "business continuity plan" that will strengthen the existing emergency response plan, explained Denis Coulombier.
When an alert is notified by a Member State, it is assessed within 24 hours and an action plan is established during a teleconference with the European Commission and the Member States. A coordinator of the alert is appointed, who is permanently allocated to the crisis in question and sets up a crisis committee comprising three working groups (administrative support - scientific and technical evaluation - communications), the size and composition of which vary in line with requirements.
To date, the crisis operations room has experienced three major emergencies, two of which were exercises. The real alert took place the week of opening and before the validation exercise had even been carried out. It was a highly hypothetical risk of the spread of tuberculosis on several transatlantic and European flights. The alert was raised by the Center for Disease Control in Atlanta in the United States and had generated massive media interest, but the American passenger in question did not display any symptoms and was unlikely to spread the disease (he was not coughing). As a precautionary measure, it was decided to test all passengers sitting up to two rows behind and in front of the passenger on all aircraft he had boarded.
"With the exception of the United Kingdom, which has a highly developed crisis centre," there are no comparable mechanisms in the Member States, explained Denis Coulombier. Although "in the United States, there are giant screens, as in Houston and NASA," that is also because the CDC there has a more developed management role and can deploy up to 200 five-man teams on the ground, he added. "We will never have 200 teams on the ground. Our role is different: we do not duplicate what the Member States do (…) We have more of a coordination, management and exchange of information role, ensuring coherent intervention." This does not stop ECDC sending people into the field. Some 26 teams of epidemiologists have travelled to various parts of the world, many via the WHO: Turkey for bird flu; Iraq in 2006; Russia during an outbreak of hospital infections; Cyprus; Romania; Georgia; Vietnam; Azerbaijan; Bolivia and Italy during the outbreak of chikungunya on 2007. These missions also serve to train epidemiologists in the field (the EPIET programme).
It took eighteen months and €1.5 million to set up the crisis management room and the annual operating costs are in the order of €150,000. Before leaving the room, we asked Dr Coulombier what was lacking today. "Nothing fundamental," he replied, adding: "We have structures and a budget. We moved very quickly, going from nought to 250 in three years. I am very surprised at how easy it has been to recruit motivated staff. (…) We are building on ten years of working in networks. It was tough to start with but people have got to know one another and a common culture has developed in the public health programme. (…) We have everything we need today."
During our visit, the centre was preparing to closely monitor health risks with the Chinese authorities (the start of the new influenza season, pollution, haemorrhagic fevers, enterovirus 71, etc.) to prepare for the Olympic Games in Beijing, attended by sportsmen and women of course, but also tourists and 15,000 journalists.
Reducing resistance to antibiotics
One of the priorities of the European Centre for Disease Prevention and Control is tackling hospital infections and resistance to antibiotics. As Dr Dominique Monnet explained, resistance to antibiotics is not automatic. Many studies show that sensible use of medicines can reduce resistance.
The ECDC uses a dedicated network to monitor resistance to antibiotics. The centre's surveillance covers the spread of the hospital 'superbugs' clostridium difficile and staphylococcus aureus. There are some 4 million hospital-related infections a year across all the places where healthcare is provided, including old people's homes and long-stay units, causing approximately 37,000 deaths every year, half of which are caused by one of the seven most widespread superbugs. Hospital infections are therefore one of the ECDC's priorities for 2009, with preparation of a European prevalence study to bring together comparable data using a harmonised protocol. Initially, in 2010-2011, the research will cover university hospitals and other hospitals with intensive care units.
Meanwhile, the ECDC is actively preparing for the first EU antibiotics resistance awareness day on 18 November 2008. A website and a graphics kit have been made provided for healthcare services to encourage the sensible use of antibiotics. Many campaigns have shown, in fact, that a change in behaviour is as contingent on the patient as on the doctor prescribing the antibiotics. There is no justification for the differences in prescribing whereby people in France and Italy take twice as many antibiotics as people in the Netherlands or Switzerland. The campaign could also lead to considerable cost savings for national healthcare systems. It is estimated that one euro invested in a health awareness campaign leads to 14 euros in savings, explains Dr Monnet.
Improving the fight against vector-borne diseases
Many exotic vector-borne diseases are still carried by travellers without any danger of their spreading locally in Europe but climate change is likely to lead to the spread of new endemic diseases and it is in this context that the ECDC has set up a group of twenty or so experts to assess the situation and identify likely medium-term developments. Using a range of criteria like morbidity, the experts have come up with several priority diseases depending on transmission vectors: (1) chikungunya (spread by the aedes albopictus mosquito), (2) leishmaniasis (sandfly), (3) Congo-Crimean haemorrhagic fever, tick-borne encephalitis, Lyme disease (deer tick), tularaemia (hare ticks), (4) leptospirosis, Hantavirus (rats).
Chikungunya is top of the list for a relatively simple reason. The mosquito that spreads it is extremely widespread and there is no treatment for the disease. Forecasts on the basis of various climate scenarios all suggest the disease will spread widely across the continent of Europe. Epidemiologists currently predict, however, that European anopheles mosquitoes will be unable to spread the plasmodium falciparum parasite that causes the most severe forms of malaria in tropical regions.
At a meeting in June 2008, experts identified several priorities like mapping vectors, monitoring vectors and control and protection measures. A call for tender for work in this connection will be published in September 2008.
Improving surveillance of food and water-borne diseases
The salmonella epidemic in the United Kingdom and Ireland in August 2008 illustrates the scale and frequency of food and water-borne diseases. Ahead of drawing up priorities (the classification of illnesses is scheduled for 2009), the European Centre for Disease Prevention and Control has been working with the European Food Safety Authority to monitor all food and water-borne diseases. This currently involves the following: campylobacteriosis, cryptosporidiosis, infection with enterohaemorrhagic E. coli, norovirus infection, salmonella, hepatitis A and E, listeria, botulism, brucellosis, Creutzfeldt-Jakob Disease and other transmissible spongiform encephalopathies (TSE), shigellosis, toxoplasmosis, trichinellosis, yersiniosis, anthrax, cholera, tularaemia, echinococcosis, giardiasis, leptospirosis.
Much of the annual epidemiological report covers joint work to combat the above diseases by the ECDC, EFSA and European Commission, which has an early warning system for food and feed (RASFF). The second epidemiological report is scheduled for publication in September 2008.
To start with, cooperation had to be developed with the various epidemiological surveillance networks concerned to improve the exchange of information on epidemics likely to affect more than one European Union Member State. For the moment, exchange of information and epidemiological surveillance is limited to disease databases. A meeting is scheduled with the Member States in October 2008 to look at other information which could be collected in the same way in the EU.
An EU-wide study of the risk of listeria is planned for 2009.
Agenda
8 and 9 September: Informal meeting of health ministers in Angers (France)
10 and 11 September: Meeting of competent authorities in Stockholm (Sweden)
13 September: ECDC-WHO meeting on H1N1 human flu virus resistance to oseltamivir (Portugal)
23 September: Special meeting of ECDC board in Stockholm to discuss outcome of external evaluation of ECDC
8 and 9 October: Eurosurveillance meeting in Stockholm
9 and 10 October: Meeting of advisory forum in Stockholm
8 au 11 November: Intergovernmental WHO meeting on viruses, in Geneva (Switzerland)
13 and 14 November: Meeting of ECDC board in Paris (France)
18 November: First European antibiotics resistance awareness day
19 to 21 November: European Scientific Conference on Applied Infectious Disease Epidemiology in Berlin (Germany)
9 and 10 December: Meeting of advisory forum in Stockholm