Address https://gelex.eu/eli/EU/doc/http://publications.europa.eu/resource/cellar/a1eb5f7a-738a-44fc-8cd2-aa28b2aa34d0.0006.01@2016-12-05/en

Contents

1. Preamble
2. ANNEX
3. ANNEX I PREPAREDNESS AND RESPONSE PLANNING IN THE INTERNATIONAL CONTEXT
4. PUBLIC HEALTH EMERGENCIES OF INTERNATIONAL CONCERN (PHEIC) 3.
5. THE IHR AND THE EU 4.
6. BOX A PUBLIC HEALTH EMERGENCY DECLARATION IN THE EU
7. ANNEX II DESCRIPTION OF MAIN ROLES AND RESPONSIBILITIES IN THE EU FRAMEWORK FOR PROTECTING CITIZENS AGAINST SERIOUS CROSS-BORDER THREATS TO HEALTH
8. Member State public health authorities 1.2.
9. EUROPEAN COMMISSION — DG HEALTH AND FOOD SAFETY 3.
10. EUROPEAN CENTRE FOR DISEASE CONTROL AND PREVENTION (ECDC) 4.5.
11. ANNEX III OVERVIEW OF AUDITED CO-FUNDED ACTIONS

The ECA’s special reports set out the results of its performance and compliance audits of specific budgetary areas or management topics. The ECA selects and designs these audit tasks to be of maximum impact by considering the risks to performance or compliance, the level of income or spending involved, forthcoming developments and political and public interest. This performance audit was produced by Audit Chamber I — headed by ECA Member Phil Wynn Owen — which specialises in sustainable use of natural resources. The audit was led by ECA Member Janusz Wojciechowski, supported by Kinga Wiśniewska-Danek, head of private office; Katarzyna Radecka-Moroz, private office attaché; Colm Friel, principal manager; Stefan den Engelsen, head of task, and Joanna Kokot, deputy head of task. The audit team consisted of Aris Konstantinidis, Jurgen Manjé, Roberto Resegotti and Frédéric Soblet. Language support was provided by Madis Rausi. From left to right: C. Friel, A. Konstantinidis, K. Radecka-Moroz, S. den Engelsen, J. Wojciechowski, J. Manjé, J. Kokot, R. Resegotti, F. Soblet. AMR antimicrobial resistance Chafea Consumer, Health, Agriculture and Food Executive Agency DG ECHO Directorate-General for European Civil Protection and Humanitarian Aid Operations DG HOME Directorate-General for Migration and Home Affairs DG RTD Directorate-General for Research and Innovation EEA European Economic Area ECDC European Centre for Disease Prevention and Control ERCC Emergency Response Coordination Centre ERCEA European Research Council Executive Agency EWRS early warning and response system FP7 seventh framework programme for research HEOF Health Emergency Operations Facility HSC Health Security Committee IHR International Health Regulations (see Annex I) MERS Middle East respiratory syndrome PHEIC Public Health Emergency of International Concern REA Research Executive Agency SARS severe acute respiratory syndrome SCHEER Scientific Committee on Health, Environmental and Emerging Risks SOP standard operating procedure STAR strategic assessment and response TESSy The European Surveillance System TFEU Treaty on the Functioning of the European Union WHO World Health Organisation In the previous decades, various events posing serious threats to health and life have led to increased attention for health security at the international and EU levels. Threats to public health can emerge from a range of different origins. In addition to their health impact, they can cause very significant economic costs, in particular when an emergency lasts for a long time and disrupts travel and trade, and public life in general. Past events have also showed that serious health threats are often cross-border problems, and may require a multi-sectoral and multilateral response. The Treaty on the Functioning of the European Union (TFEU) states that a high level of human health protection shall be ensured and that Union action shall cover the monitoring, early warning of and combating of serious cross-border threats to health. It specifies that EU action in the area of health is designed to support and complement actions of the Member States, which have the main responsibility for health policy. The Commission’s role in health policy therefore consists mainly of providing support and taking complementary action. The European Union identified serious cross-border threats to health as an area where Member States can act more effectively together. It therefore developed coordination mechanisms to enable the Union to deal with such threats. A key milestone in building a stronger EU health security framework was the adoption in 2013 of a decision on serious cross-border threats to health, introducing important innovations as regards, for example, the coordination of preparedness planning and the strengthening of the role of the Health Security Committee (HSC). The EU health and research framework programmes also support activities in the field of health security. Implementing the decision on serious cross-border threats to health and the related framework is complex in view of the competences of the EU and the Member States, and the fact that serious threats keep emerging. We therefore assessed whether the EU framework for protecting citizens from serious-cross-border threats to health was adequately implemented. Under this main question we examined: (1) whether the innovations introduced by the decision are effectively implemented; (2) whether the existing systems for early warning and response and epidemiological surveillance are adequately managed and implemented; (3) whether the EU health programmes are making effective contributions to protecting citizens from threats to health; (4) whether the Commission’s internal coordination in terms of health security funding and public health crisis management is adequate. We concluded that Decision No 1082/2013/EU on serious cross-border threats to health represents an important step for dealing better with such threats in the EU. However, significant weaknesses at Member State and Commission level affect the implementation of the decision and the related EU framework. While the nature and scale of future threats is unknown and may evolve, more needs to be done to address these weaknesses for the Union to take full benefit from the established mechanisms. As regards the innovations introduced by the decision on serious cross-border threats to health, we found that their implementation and development were hampered by delays, potentially reducing their effective functioning. The coordination of preparedness planning was initiated but the relevant procedures need to be more robust and better defined to deliver clear-cut results. The Member States have shown insufficient responsiveness to speed up the joint procurement of pandemic influenza vaccine, and there is not yet an EU mechanism to address urgent needs for medical countermeasures within the framework of the decision. The work and role of the HSC have proven to be very important, but it is facing strategic and operational challenges which need to be tackled, including in relation to the coordination of response rules. As regards the effective implementation of the existing systems for early warning and response and epidemiological surveillance, we found overall that these systems have been operational for years and that their important role at EU level is widely recognised by stakeholders. However, there is scope for making certain upgrades to the Early Warning Response System (EWRS) and related procedures. We concluded that the performance of the health programme as regards protecting citizens from health threats showed weaknesses. Most of the audited health threat actions from the second health programme (2008-2013), despite performing well in terms of producing the agreed deliverables, showed a lack of sustainable results, limiting their contribution towards achieving the objective of protecting citizens from threats to health. We also found weaknesses in measuring the indicator for the health threats objective under the third health programme (2014-2020) and a relatively low level of spending in 2014-2016. Finally, the audit revealed that a number of gaps existed in relation to the Commission’s internal coordination of health security activities across different services and programmes. We also found that more work needs to be done to make agreements for cooperation between Commission crisis management structures fully operational, and that DG Health and Food Safety’s management of its Health Emergencies Operations Facility showed weaknesses that might hamper its performance. The Court makes a number of recommendations to address these observations: (i) In order to speed up the development and implementation of the innovations introduced by the decision on serious cross-border threats to health, the Court makes recommendations covering a strategic HSC roadmap for the implementation of Decision No 1082/2013/EU; the performance monitoring of this policy area by the Commission; the working methods of the HSC; and the joint procurement of medical countermeasures (see detailed Recommendation 1 (a) to (d), following paragraph 118). (ii) In order to further upgrade the EWRS and develop more integrated solutions for related risk management procedures, the Court makes recommendations on the development of the EWRS (see detailed Recommendation 2 (a) and (b), following paragraph 119). (iii) In order to address the main weaknesses identified in the performance of the health programme for actions addressing health threats, the Court makes recommendations on improving the sustainability of results from co-funded actions and the relevant performance measurement methodology (see detailed Recommendation 3 (a) to (c), following paragraph 120). (iv) In order to bridge the gaps in the Commission’s internal coordination of activities relevant to health security and public health crisis management, and to improve the design of its Health Emergencies Operations Facility, the Court makes specific recommendations on a more structured coordination approach between services for health security activities, operationalising existing crisis management agreements and specific improvements for the Health Emergencies Operations Facility (see detailed Recommendation 4 (a) to (c), following paragraph 121). In the previous decades, deadly events such as the 2003 severe acute respiratory syndrome (SARS) epidemic, the worldwide H1N1 pandemic of 2009 and the 2011 E. coli outbreak in Germany have led to increased attention being given at international and EU levels to health security. More recently, the worst Ebola outbreak ever in west Africa showed the serious implications for health and other sectors, not only in the affected regions, but also in countries across the world receiving travellers and patients from those regions. The outbreak clearly demonstrated the challenges which arise when a public health emergency is of a serious and cross-border nature (see Box 1). In March 2014 Guinea notified to WHO an outbreak of Ebola virus disease. On 8 August 2014, the Director- General of WHO declared the Ebola outbreak in west Africa a public health emergency of international concern (PHEIC — see Annex I for a description). This outbreak hit three countries directly (i.e. Guinea, Sierra Leone and Liberia) and was the worst ever epidemic of the disease with potentially more than 28000 cases and 11000 deaths, including hundreds of healthcare workers. The epidemic evolved into a public health, humanitarian and socioeconomic crisis with an unprecedented impact in affected countries. It posed multi-sectoral challenges for the response action stretching far beyond the public health and healthcare sectors, involving a multitude of actors. Seven other countries (i.e. including Italy, Spain and the United Kingdom) later reported imported cases of Ebola. This mainly concerned healthcare or aid workers returning or evacuated to their home country after having contracted the disease. The presence of many such foreign workers on the ground, including from Europe, posed additional challenges, in particular for organising medical evacuation and ensuring preparedness of healthcare facilities for treating cases of Ebola in European countries. The PHEIC for Ebola was terminated by the WHO Director-General on 29 March 2016. Serious cross-border threats to health are life-threatening or otherwise serious hazards to health of biological, chemical, environmental or unknown origin which may spread across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection (see Box 2 for examples of such threats). In addition to the human and health-related costs, serious threats to public health have the potential to cause very significant economic costs, in particular when the outbreak lasts for a longer period of time and disrupts travel and trade, and potentially public life in general. These types of threats usually strike unexpectedly and might evolve rapidly into complex, large-scale emergencies. Health security policy and actions are therefore designed to protect citizens from such threats and avoid or mitigate severe impacts on society and the economy. In October 2010, a major chemical incident occurred when liquid waste spilled from a caustic water reservoir of an alumina plant in Hungary. A wave of the sludge hit nearby localities causing deaths and injuries, with many people being treated for chemical burns. The toxic sludge eventually reached the Danube River prompting downstream countries to develop emergency response plans. Hungary also called upon the EU Civil Protection Mechanism for urgent international assistance. The 2011 E.coli outbreak made 3910 people ill and caused 46 deaths within 2 months. It led to overflowing intensive care units in Germany, shortages of medical equipment, extreme pressure on laboratory capacity and a lack of public confidence in health measures. This epidemic had a major impact on the agriculture sector in the EU. Losses for economic operators were estimated at hundreds of millions of euros, and compensation and aid schemes were put in place by the EU. Surveillance data show that antimicrobial resistance (AMR) is a growing public health problem in European hospitals and communities, mainly linked to the inappropriate use of antibiotics. AMR threatens the effective prevention and treatment of an ever-increasing range of infections caused by bacteria, parasites, viruses and fungi. According to WHO, AMR is an increasingly serious threat to global public health that requires action across all government sectors and society as new resistance mechanisms emerge and spread globally. The Treaty on the Functioning of the European Union (TFEU) includes provisions on health and provides, among other things, that a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities and that Union action shall cover the monitoring, early warning of and combating serious cross-border threats to health. It also specifies that EU action in the area of public health is designed to support and complement actions of the Member States, which hold the main responsibility for health policy. The Commission’s role in health policy therefore mainly consists of providing support and taking complementary action where needed. One of the three objectives of the EU health strategy for 2008-2013 was to protect people from health threats. According to the Commission’s 2011 mid-term evaluation of the health strategy, the objectives and principles of the health strategy were consistent with Europe 2020, by promoting health as an integral part of the smart and inclusive growth objectives. It therefore remained valid towards 2020. Other relevant Commission publications on EU health security and the wider area of internal security referred to the fact that these health threats are often cross-border problems with an international impact. According to these strategies, Member States cannot effectively respond to such threats alone, providing a basis for Union action in this field. The Council of Health Ministers had already established in 2001 an informal Health Security Committee (HSC), as one of the mechanisms to coordinate Member State actions in response to health security issues. At that time, the main EU legislation to protect citizens from health threats concerned communicable diseases. Decision No 2119/98/EC set up a network for the epidemiological surveillance and control of communicable diseases in the Community, including an early warning and response system (EWRS). In 2004, the European Centre for Disease Prevention and Control (ECDC), an independent European agency, was founded. It started working in 2005 and took on the hosting and coordination of the epidemiological surveillance network and the EWRS. At international level, the Commission collaborates with the Global Health Security Initiative and WHO. WHO coordinates the implementation of the International Health Regulations 2005 (see Annex I for more detailed information on the International Health Regulations (IHR)), a legally binding treaty in force since 2007, adopted in the context of the growth in international travel and trade, and the emergence and re-emergence of international disease threats and other public health risks (see Table 1 for an overview of major threats since the adoption of the IHR). All EU Member States are State Parties to the IHR and need to develop, strengthen and maintain core public health capacities for surveillance and response. They also report to WHO on IHR implementation. Source: WHO Fact Sheets and thematic websites on the relevant diseases as per July 2016. Year Major disease outbreaks Health impact PHEIC declaration by WHO 2009 H1N1 influenza pandemic (or 'swine flu') 18449 deaths in more than 214 countries and territories or communities (as per 1 August 2010). April 2009 2012 Middle East respiratory syndrome coronavirus (MERS-CoV) 1769 confirmed cases in 27 different countries and 630 deaths reported since September 2012. N.A. 2013 Avian influenza H7N9 in human beings Case fatality rate approximately 25 %. Previous cases of other subgroups of H7 avian influenza reported in multiple countries in earlier years. N.A. 2014 Resurgence of polio after it had nearly been eradicated In 1988 there were 350000 cases in 125 countries; in 2015 74 cases in 2 countries. May 2014 2014 Ebola outbreak in west Africa More than 28000 cases confirmed in Guinea, Liberia and Sierra Leone and more than 11000 deaths. August 2014 2016 Zika virus outbreak As of June 2016: 61 countries reporting ongoing mosquito-borne transmission. February 2016 In an effort to coordinate Member State actions relevant to health security in the Union, Decision No 1082/2013/EU on serious cross-border threats to health was adopted. It introduces the concept of an ‘all hazards approach’ (i.e. similar to the IHR) in the European legislation and puts certain obligations on the Member States and the Commission for cooperation and coordination in specific areas (see Figure 1). Source: European Court of Auditors. The decision should enable the EU to better address risks related to serious cross-border threats to health. Its innovations in EU legislation include the formalisation and strengthening of the role of the HSC and rules on response coordination; extension of the EU legal framework to also cover threats other than communicable diseases (notably chemical and environmental threats and threats from unknown origin, but also antimicrobial resistance and bio-toxins); consultation on and coordination of preparedness planning; and a new legal basis for the already existing Early Warning and Response System and epidemiological surveillance network. Another innovation of the decision is the joint procurement of medical countermeasures (e.g. vaccinations), which provides that if a Joint Procurement Agreement (JPA) is signed, specific joint procurements of medical countermeasures can be organised. The decision also provides that the Commission may declare an EU emergency situation (see Annex I). As stated in paragraph 3, the main responsibility for health policy lies with the Member States. Additionally, the decision on serious cross-border threats to health puts a number of specific obligations on Member States for the areas described in paragraphs 7 to 9, including to nominate certain bodies and representatives for EU-level coordination structures. The Commission (i.e. in particular DG Health and Food Safety) is responsible for the implementation and development of the relevant parts of the EU health strategy and policy. It also has specific responsibilities under the decision, including providing the secretariat and presidency of the HSC, and operates its Health Emergency Operations Facility. The European Centre for Disease Control and Prevention operates the network for epidemiological surveillance of communicable diseases and the Early Warning and Response System (for a more detailed description of these responsibilities, see Annex II). The EU’s health strategy is supported by multiannual health programmes. The second programme ran from 2008 to 2013. The third programme is being implemented in the period 2014 to 2020. The Consumer, Health, Agriculture and Food Executive Agency (Chafea) is largely responsible for the management of the health programme. Objective 2 of the 2014-2020 health programme, which is relevant to our audit, is aligned with the activities and definitions of the decision on serious cross-border threats to health. Table 2 provides an overview of the relevant objectives and spending or budget. Source: ECA, based on information provided by the Commission. Second health programme 2008-2013 Third health programme 2014-2020 Total operational budget for the period 247 million euro 405 million euro Number of main objectives 3 4 Sub-actions/priorities 19 23 Relevant strand for this audit 1: Improve citizens’ health security 1.1: Protect citizens against health threats 2: In order to protect Union citizens from serious cross-border health threats: identify and develop coherent approaches and promote their implementation for better preparedness and coordination in health emergencies. Spending/budget for this strand 32 million euro for Action 1.1 (approximately 13 %) Estimated 12 million euro based on the 2013 multi-annual planning for 2014-2016 (approximately 3 %). Other EU funds, in particular the research framework programmes (FP7 in 2007-2013 and Horizon 2020 for 2014-2020), also provide funding for actions related to health security. The thematic areas ‘Health’ and ‘Security’ under the FP7 cooperation programme invested more than 7 billion euro. DG Research and Innovation and DG Migration and Home Affairs are the directorates-general in charge of this thematic areas. The new Horizon 2020 programme also addresses health and security research. It is estimated that during 2014-2020 the EU will invest some 9.1 billion euro in these areas. For health this includes the objective of enhancing the ability to monitor health and to prevent, detect, treat and manage disease. Grants awarded under these programmes might therefore be directly relevant to health security policy and dealing with serious cross-border threats to health. In defining the audit scope and objectives, we considered the EU framework for protecting citizens from serious cross-border threats to health to consist mainly of Decision No 1082/2013/EU on serious cross-border threats to health and the EU resources made available to support its implementation. Overall, this framework fits into the wider context of the EU health strategy. The audit work addressed the following main audit question: Is the EU framework for protecting citizens from serious cross-border threats to health adequately implemented? Under this main question we examined:

(i) whether the innovations introduced by the decision are effectively implemented;

(ii) whether the existing systems for early warning and response and epidemiological surveillance are adequately managed and implemented;

(iii) whether the EU health programmes are making effective contributions to protecting citizens from threats to health; and

(iv) whether the Commission’s internal coordination in terms of health security funding and public health crisis management is adequate.

The scope of the audit is closely aligned with the various areas of the decision on serious cross-border threats to health (also see Figure 1 above). Sub-question 1 covered the innovations introduced in EU legislation by the decision (e.g. coordination of preparedness planning, joint procurement and the strengthened role of the HSC, see paragraphs 7 to 9), and sub-question 2 covered the systems that already existed previously (i.e. for epidemiological surveillance and early warning and response). The audit scope also included an assessment of the management of EU resources made available to contribute to protecting citizens from health threats. Under sub-question 3 we assessed relevant actions and projects by DG Health and Food Safety and Chafea for the 2008-2013 and, to a certain extent, 2014-2020 programming periods. Under sub-question 4 we assessed general performance and coordination activities, notably at the level of DG Health and Food Safety’s Crisis Management and Preparedness in Health Unit and ECDC’s relevant operational units. We also looked into DG Health and Food Safety’s coordination with other Commission services, especially in relation to research programmes with health security objectives, as well as to crisis management structures. The Court does not have the mandate to examine the implementation of the WHO IHR by the Member States or the general implementation of preparedness plans at national level. This was therefore not part of the audit scope. However, certain IHR concepts were considered during the audit. As regards our audit work on the coordination of crisis management structures the audit scope did not include a full assessment of their functioning across multiple directorates-general or as part of the EU response to the Ebola outbreak. Questions 1 to 4 were addressed at the level of the Commission (i.e. DG Health and Food Safety, and for questions 3 and 4 information visits were also made to DG Migration and Home Affairs, DG Research and Innovation, the Research Executive Agency (REA) and the European Research Council Executive Agency (ERCEA)) and ECDC, and discussed during information visits to four Member States. In addition to interviews during the site visits, we conducted an information visit to WHO Europe, performed a desk review of 20 health programme actions (see Annex III for an overview of these) and the objectives of ten FP7 projects (see Annex III) and consulted Commission progress and implementation reports, as well as documents relating to the work of the HSC. The materiality and potential impact relevant to the implementation and management of the areas included in the audit scope should mainly be judged by the potential costs and consequences of not dealing with cross-border public health threats in the most effective way. Emergency situations typically require the immediate availability of significant (financial) resources for response actions, and all the more so if the early response is slower or less effective than required. In addition, damaging impacts are not restricted to human health, but also potentially extend to many sectors of the wider economy, as described in paragraphs 1 and 2. Given the unpredictable nature and scale of future public health emergencies it is not possible to quantify such damages and impacts up front. We examined whether the innovations introduced by the decision on serious cross-border threats to health, as described in paragraphs 7 to 9 and Figure 1, were effectively implemented. Overall we found that the implementation and development of these innovations were hampered by delays, and that strategic and operational challenges remain. In the following paragraphs we report on insufficiently clear-cut results from the preparedness planning consultation and coordination and the weak measurement of performance for these activities. We also report on ECDC’s role in generic preparedness, which is not sufficiently formalised, the slow progress in joint procurement of medical countermeasures and the absence of an EU mechanism to address urgent needs for medical countermeasures within the framework of the decision on serious cross-border threats to health. Finally, we report on operational and strategic challenges for the Health Security Committee and difficulties in applying the coordination of response rules. Member States and the Commission should consult each other within the HSC with a view to coordinating their efforts to develop, strengthen and maintain their capacities for the monitoring, early warning and assessment of, and response to, serious cross-border threats to health. That consultation should be aimed at sharing best practices and experience in preparedness and response planning, promoting the interoperability of national preparedness planning and addressing the need for different sectors (e.g. health, civil protection, transport, border control) to work together in preparedness and response planning at Union level. It should also support the implementation of core capacity requirements for surveillance and response as referred to in the IHR (see Annex I). Member States should submit to the Commission by 7 November 2014, and every 3 years thereafter, an update on the latest situation with regard to their national preparedness and response planning for the main areas described above. To ensure compatibility and relevance of the information to the objectives, the submission of this information is based on a template adopted by the Commission. The Commission, in consultation with the Member States, adopted the template for providing the preparedness information in July 2014, only 4 months before the deadline for completion of the questionnaire by the Member States, during the Ebola crisis. Nine Member States submitted their replies on time through an electronic survey. A further 17 Member States submitted their replies late, mostly in 2015, after the Commission had reminded them several times. The Commission worked with ECDC and WHO Europe to compile a progress report on preparedness and response planning based on the Member State replies, which was put to the HSC in June and November 2015. Despite the delays in submitting the replies, this initiated the required exchange of information on preparedness and response planning. However, most of the information included in this report, apart from some geographical maps sourced from WHO reports, is anonymised and aggregated. It therefore does not show members of the HSC which country provided which information, suggestions for improvements or best practices, or examples, to allow for efficient and transparent exchanges of views, despite the confidential character of the HSC and the report itself. Neither the decision on serious cross-border threats to health nor the template for the questionnaire require Member States to provide supporting evidence such as implementation or action plans, national manuals or actual preparedness plans. The legislation does not provide the Commission with the mandate to collect or verify such information, for example during country visits. The information included in the progress report on relevant aspects of preparedness is solely based on self-assessments by the Member States and does not contain supporting evidence. Although this does not mean that the reported information is inaccurate, the consequence is that strengths and weaknesses identified in the report and presented to the HSC are not based on data that was externally verified or reviewed. Such reviewing and increased transparency, while not foreseen by the legislation, are likely to contribute to a higher level of confidence in relation to preparedness for serious cross-border health threats (see Box 3 on weaknesses in self-assessment in relation to IHR implementation), and would allow for better targeting of actions needed to address weaknesses. Weaknesses inherent in self-assessments on IHR core capacity implementation have been signalled by WHO and its expert panels. The Ebola Interim Assessment Panel wrote in July 2015 that it considered it to be unacceptable that only voluntary self-assessment is required for the measurement of IHR core capacities. It referred to encouraging efforts, both within WHO and through initiatives such as the Global Health Security Agenda (see Annex I describing other initiatives addressing the need to enhance preparedness planning and increase transparency), to promote evaluation frameworks, external monitoring and transparency about core capacities and underlined that regional political agencies, such as the European Union can support this work. The 69th World Health Assembly (23 to 28 May 2016) considered the report of the Review Committee on the role of the IHR in the Ebola outbreak and response and arrived at a similar conclusion. The Review Committee identified a lack of implementation of the IHR as contributing to the escalation of the Ebola outbreak. The approaches proposed by the Review Committee to strengthen implementation of the IHR include recognition of external assessment of country core capacities as a best practice. Some Member States, despite their involvement in developing the template, found it difficult in practice to reply to the preparedness questionnaire and therefore had some reservations about findings in the progress report. In addition, the technical implementation of the questionnaire through the online survey showed weaknesses limiting the data quality for certain questions. This was in part due to the fact that ECDC was not involved sufficiently early by DG Health and Food Safety in the IT preparations for using the online survey tool. As regards any potential EU criteria for preparedness and response planning, on top of the basic criteria in the decision, the Commission, in its 2011 Impact Assessment referred to the availability of extensive guidance on generic preparedness planning for all types of health threats, and the fact that there was no mechanism in place to ensure its implementation in all Member States. We found that this guidance was not given any status under the framework of the decision on serious cross-border threats to health and that awareness about its content is generally low, despite significant efforts made by the Commission and several Member States to produce the comprehensive, updated version of 2011 and the translations available on the Commission’s website. If the guide is not used by the Member States, or kept up to date, this significant investment of resources is potentially lost. Overall we found that the consultation between Member States and the Commission on preparedness and response planning has been initiated as required. However, the procedures for obtaining and exchanging relevant information with a view to better coordinating efforts in relation to preparedness are not yet sufficiently robust and have not yet delivered clear-cut results. The Commission should measure the effectiveness of Union policies and programmes. This also applies to the EU policy objectives of the decision on serious cross-border threats to health, and in particular the efforts made under Article 4 on preparedness and response planning referred to above. SMART objectives and indicators therefore need to be defined, in close contact with the Member States, and a methodology to enable a clear progress measurement and evaluation. Member States in turn then need to demonstrate their progress. DG Health and Food Safety’s objectives for health in the current programming period (2014-2020) include a specific objective related to the protection of citizens from serious cross-border health threats: to identify and develop coherent approaches and promote their implementation for better preparedness and coordination in health emergencies. The related specific result indicator is: ‘Number of Member States integrating the developed common approaches in the design of their preparedness plans […]’. For this specific objective and indicator, the Commission, in its management plans for 2014 and 2015, set the targets at four Member States integrating the developed common approaches in the design of their preparedness plans by 2015, 14 by 2017 and all Member States by 2020. However, the objective and indicator are not included as such in the decision, meaning that Member States are not bound by them. It also does not provide criteria on what constitute integrated common approaches in the design of preparedness plans, which, according to the objective would still have to be identified and developed. We found that when the Commission set the indicator targets, neither was this concept of common approaches further developed by the Commission in agreement with the Member States, nor was there a clear and agreed approach to measuring progress. Early in 2016, the Commission refined its methodology to measure the progress under the specific indicator and requested ECDC to perform further analysis on the data received from Member States. ECDC was asked to measure the number of Member States that had in place the elements of IHR core capacity implementation, interoperability arrangements between sectors and business continuity plans. ECDC concluded that 16 Member States declared that they had these elements in place and that the indicator for 2015 was therefore ahead of target (i.e. 14 by 2017). However, as illustrated in paragraph 32, we could not confirm that this methodology was discussed with and endorsed by the HSC. We were therefore unable to conclude what the reported progress means in terms of performance and whether all definitions and concepts of the objectives, indicators and targets are supported by the Member States. This is especially important as the effective coordination of preparedness and response planning for serious cross-border threats largely depends on them, and requires stakeholders to work towards the same objectives. ECDC has a mandate to support Member States and the Commission in preparedness activities. ECDC’s mandate was traditionally for disease prevention and control and has not been formally updated since its establishment, despite important health security developments, in particular the entry into force of the IHR and the adoption of the decision on serious cross-border threats to health. We therefore examined whether it was sufficiently clear between the Commission and ECDC, as well as vis-à-vis ECDC’s stakeholders, to what extent ECDC can provide expertise in the area of generic preparedness and how it should plan its activities and resources for this purpose. ECDC’s founding regulation states that it can provide scientific and technical expertise to the Member States, the Commission and other Community agencies in the development, regular review and updating of preparedness plans, and also in the development of intervention strategies in the fields within its mission (i.e. protection from infectious diseases and threats of unknown origin). The decision on serious cross-border threats to health specifically attributes tasks to ECDC for epidemiological surveillance and early warning and response, but not for support on preparedness planning. Following the adoption of the decision on serious cross-border threats to health, ECDC has been working on new tasks, especially in the area of generic preparedness, addressing the need for the EU to have an all-hazards approach. However, we found that ECDC’s role and responsibilities in relation to generic preparedness were not formally defined and agreed, either through updates of the relevant legislation or, for example, in a written agreement between the Commission and ECDC, endorsed by ECDC’s stakeholders. If there is insufficient formal clarity on ECDC’s role in these activities and how they fit its mission, the organisation may not be able to properly prepare itself for such tasks in the long term, nor to respond effectively to requests for assistance. The risk stemming from this situation has already materialised in relation to joint work done by ECDC and WHO on a guide for influenza pandemic plan revision, as illustrated below. After the pandemic influenza of 2009 one of the Council’s main recommendations was the adoption of guidance on preparedness plans. Countries across Europe started revising their pandemic plans based on the lessons learned. ECDC and WHO Europe made a substantial effort in organising workshops and review work. They published a joint document in 2012 listing the outcomes of this exercise. Subsequently, they worked on a ‘Guide for influenza pandemic plan revision’. The drafted guide was addressed to all 53 countries in the WHO European region and was developed by experts in pandemic preparedness planning from various countries and organisations. However, the Commission put on hold the publication of the guide by ECDC in March 2014, invoking doubts as regards ECDC’s mandate to issue this type of guidance directly to the Member States and concluding that the HSC is the appropriate and mandated body to discuss matters of preparedness. At the time of the audit (2 years later) the timelines for discussion of the guide by the HSC (or its preparedness working group) and its publication were not known. Not publishing and promoting this guide would constitute a lost investment in terms of the resources and efforts engaged for its production and means that EU Member States and WHO Europe countries had no access to it even when efforts were made at national level to update pandemic preparedness plans. Following the H1N1 influenza pandemic crisis in 2009, the Council invited the Commission to report on and develop, as soon as possible and no later than December 2010, a mechanism for joint procurement of vaccines and antiviral medication. Already in 2011, the Commission had invited Member States to provide needs analyses in relation to such a joint procurement procedure. However, it was not until 2013, through the adoption of the decision on serious cross-border threats to health, that there was an EU legal basis for the joint procurement of medical countermeasures. The Commission adopted the Joint Procurement Agreement on 10 April 2014. Countries which have signed the Joint Procurement Agreement can participate in specific joint procurement procedures for medical countermeasures, which require a minimum of four Member States. In February 2016, the Commission successfully finalised and published the specifications for the joint procurement of personal protective equipment, initiated in the wake of the Ebola crisis. In addition, several other specific joint procurement procedures have been started. However, preparation of the specific joint procurement procedure for pandemic influenza vaccine, initially requested by the Council in 2010, was still ongoing. Despite various requests sent by the Commission only five Member State needs assessments had been received by April 2016. Future progress depends on the Member States’ commitment to these procedures. The Commission reported in its Annual Activity Reports for 2014 and 2015 that the targets for joint procurement of pandemic influenza vaccine had not been met. An emergency instrument to address urgent needs of medical countermeasures would require less complexity and provide higher speed and greater flexibility than the joint procurement agreement provides. Following a case of diphtheria in Spain in 2015, when the treating hospital struggled to get antitoxin in Europe, the HSC and the Commission decided to look into potential solutions to address such cases in the future. The HSC agreed to task its preparedness working group with the development of standard operating procedures for a rapid and consistent Union response in such emergencies. In January 2016, the Commission requested Member States to nominate participants in the HSC preparedness group on a standard operating procedure for exchanging medical countermeasures. However, during the audit we could not obtain evidence that the relevant procedure had been agreed or that specific work had been initiated (also see paragraphs 46 and 47). Overall, as regards the implementation of the joint procurement provisions, we found that progress in organising the joint procurement of pandemic influenza vaccine, initiated after the 2009 H1N1 pandemic, had been slow by the time of our audit due to low Member State responsiveness and that there is no mechanism at EU level to address urgent needs for medical countermeasures, potentially reducing the EU’s preparedness for pandemic influenza. The decision on serious cross-border threats to health establishes the HSC, composed of representatives from the Member States, and chaired by the Commission (see Annex II for a more detailed description of its role and responsibilities). All Member States have nominated their members of the HSC. Plenary meetings took place once in 2014 and three times in 2015, as well as a large number of audioconferences, in particular in relation to the evolving Ebola crisis (see Box 4). Discussions about Ebola started in the HSC in March 2014, after the initial notification of the outbreak by Guinea to WHO and the issuance of a rapid risk assessment by ECDC. According to this rapid risk assessment, the risk of transmission to the EU was low, although certain situations could justify measures in the EU, such as tourists returning from Guinea visiting family and friends or exposed persons seeking medical attention in the EU. The Ebola outbreak was declared a PHEIC by WHO on 8 August 2014. A week earlier, the Commission had called an HSC audioconference meeting in view of the quickly deteriorating circumstances in the affected countries. Many different Commission services, ECDC, WHO and the Member States attended. The objective was to exchange information and coordinate actions on measures being taken and planned, to identify additional actions to strengthen preparedness and to consider assistance to affected countries. Options for the medical evacuation of EU/EEA citizens working in them were also discussed. DG Health and Food Safety, with assistance from ECDC, had drafted a questionnaire on Ebola preparedness (i.e. to obtain an overview of laboratories capacities, hospital facilities for Ebola, suitable transport), which was sent out to the Member States and answered by most of them. After the declaration of the PHEIC by WHO, the frequency of HSC meetings dedicated to Ebola increased significantly (almost weekly until January 2015). Only from February 2015, did operational topics return to the HSC agenda, such as joint procurement and the working groups. At the time of our audit, the terms of reference had been drafted for four working groups under the HSC: a permanent working group on preparedness, a permanent communicators’ network, an ad hoc working group on newly arrived migrants and communicable diseases, and an ad hoc working group on combating antimicrobial resistance (AMR) (see Box 2). However, the HSC only formally established the communicators’ network and preparedness working group. Based on their terms of reference, these working groups were to prepare an annual work plan, including performance indicators for evaluation, to be submitted and approved by the HSC, to ensure a structured way of working on these topics. We found that at the end of the audit (March 2016) no annual work plans with the indicators required under the working groups’ terms or reference had been submitted for approval to the HSC. This means that the work done by these working groups is not implemented in accordance with the terms of reference and that their performance is not measured appropriately. Participation in the HSC working groups is voluntary. At the end of our audit, all Member States had nominated their participants in the communicators’ network. The Commission had also sent the request to nominate participants to the preparedness working group (also see paragraph 42 above), but by March 2016 only nine EU Member States had done so. The participation of a large number of Member States is important to ensure that outputs of the working groups are later supported and taken forward by the HSC. We found that when the HSC was still informal and mandated by the terms of reference issued by the Council (i.e. until 2013), it had work programmes with annual objectives and reporting, as well as documented action plans with progress reporting. The status and mandate of the current HSC are different under the decision on serious cross-border threats to health. However, we did not find evidence in the HSC documents or at the Commission that the HSC currently executes its tasks on the basis of an agreed strategic planning or up-to-date roadmap identifying relevant longer-term strategic topics. During the course of the audit, Member State representatives also expressed some concern over the nature of the HSC audioconferences, perceived by some to be too focused on technical rather than strategic discussions. Overall, the work of the HSC, in particular in response to the Ebola crisis, has been very important and has initiated the development of collaborative mechanisms, such as for the use of laboratories and for medical evacuation that could be sustained or reactivated for future crises. The HSC became a main platform where representatives from relevant Commission services and Member States joined forces and started exchanging information, including with WHO. This further demonstrates the great relevance and importance of the HSC, which was also acknowledged by the Council in its conclusions on the lessons learned for public health from the Ebola outbreak in west Africa. However, our evidence also shows that from the moment when Ebola was declared a public health emergency of international concern by WHO, for approximately 6 months, most HSC work and its audioconferences focused on the response to the Ebola crisis — which was a low-risk health threat for the EU. As a result, other HSC activities in relation to the strategic development and implementation of the framework of the decision on serious cross-border threats to health were not at the top of the agenda during this period. The high incidence of major health events in recent years, such as Middle East respiratory syndrome (MERS) Corona virus, Ebola and Zika and the absence of strategic planning for the HSC, explain to a certain extent why HSC meetings have often been of a technical, response-oriented nature, rather than strategic. In addition, we identified slow progress on the working groups which should perform or support the HSC’s technical work. The Commission itself can also still improve how it produces relevant mappings or reports on activities that take place in other Commission services, agencies and programmes in this context (also see paragraphs 96 to 102). These factors combined indicate that there is still scope for enhancing the HSC’s strategic work. This is important as the HSC now has a strong mandate, in particular in terms of coordinating, in liaison with the Commission, the preparedness and response planning of the Member States (see paragraph 44) and thereby ensuring the highest possible level of protection against health threats in the EU. The introduction of the decision on serious cross-border threats to health states that although the Member States have a responsibility to manage public health crises at national level, measures taken by individual Member States could damage the interests of other Member States if they are inconsistent with one another or based on diverging risk assessments. Therefore, Member States, when intending to adopt public health measures to combat a serious cross-border threat to health, should first inform and consult the other Member States and the Commission on those measures. If the need to protect public health is so urgent that the immediate adoption of the measures is necessary they may inform the other Member States and the Commission after the adoption. Experience during the Ebola crisis showed that this requirement to inform other Member States (i.e. through the HSC) before taking measures at national level is challenging. Some Member States decided to diverge from ECDC and WHO risk assessments and implemented entry screening of travellers at airports receiving flights from west Africa. In their subsequent risk assessments, ECDC and WHO continuously did not recommend entry screening measures, pointing at the cost implications, poor results and existence of effective exit screening in the affected countries. The Commission invited EU health ministers to a high-level Ebola coordination meeting on 16 October 2014 where possible entry measures at EU borders were also discussed. One of the outcomes was for the Commission and WHO to organise an audit on exit screening for Ebola in the affected countries in west Africa. The audit concluded that the exit screening processes were well implemented and that the procedures were very likely to catch persons with signs and symptoms of Ebola. In its 2015 implementation report the Commission therefore stated that a major conclusion from the Ebola outbreak was that there was scope for improving the implementation of the provisions which require Member States to coordinate national responses. If information on national public health measures which Member States are considering taking or have taken is not adequately shared with other Member States at an early stage, this could impact other Member States. Examples include duplications of checks and tracing of people that have already been checked on their first entry to the EU, requiring additional efforts and resources from other Member States or increased media pressure on public health authorities to explain why certain Member States follow WHO or ECDC scientific advice and others do not. We examined whether the existing systems for early warning and response and epidemiological surveillance, for which the decision on serious cross-border health threats provides the legal basis (also see Figure 1), are adequately managed and implemented. Overall, we found that these existing systems have been operational for years and that their important role at EU level is widely recognised by stakeholders, but that certain upgrades were needed to procedures and systems. In the following paragraphs we report on the need for further enhancements of the EWRS and interfacing with other alert systems and the fact that the updated EU-level approach to early warning and response for serious chemical and environmental threats is not yet tested. Finally, further work is required on the EU system for epidemiological surveillance for optimising data comparability and quality. The decision on serious cross-border threats to health provides the legal basis for the EWRS for notifying at Union level alerts in relation to serious cross-border threats to health. The EWRS should enable the Commission and the competent authorities responsible at national level to be in permanent communication for the purposes of issuing alerts, assessing public health risks and determining the measures that may be required to protect public health. ECDC should support and assist the Commission by operating the EWRS and by ensuring with the Member States the capacity to respond in a coordinated manner. ECDC should analyse the content of messages received by it via the EWRS and should provide information, expertise, advice and risk assessment. The Commission and ECDC should also take action to ensure that the EWRS is efficiently linked with other Community alert systems (e.g. animal health, food and feed and civil protection). Based on these standards, we have made a general assessment of the EWRS’s adequate functioning and management. Following the adoption of the decision, the EWRS has been modified to include changes, such as the addition of new data fields for threats other than communicable diseases and the integration of the definitions on alert notification. We found that the EWRS is widely used by the relevant Member State authorities and the Commission. Since 2004, 1493 messages have been initiated in the EWRS by the Member States and the Commission (see Figure 2). However, despite updates and upgrades over time, we found that it has inherent system limitations due to the outdated system design, which does not allow for the integration of the latest IT tools, social media connections or full mobile device compatibility. 1EC is European Commission Source: ECA, based on EWRS data provided by ECDC in October 2015. The latest ECDC external evaluation report, referring to the 2008-2012 timeframe, identified a broadly positive rating of the EWRS technical design and user-friendliness, but also noted that the performance of the EWRS during crises had been poor, stating that the system had easily overloaded in the past and that there appeared to be room to review the EWRS to enable it to better support health emergency situations. There is currently no dedicated situational awareness platform or tool at EU level for maintaining a real-time overview of national public health measures taken for dealing with a serious cross-border health threat. Either the EWRS is used for such purposes or emails are exchanged, for example between HSC members and the Commission. There is scope to develop such functionality, for example in a dedicated tool or an integrated function in an enhanced version of the EWRS. An EWRS Committee existed until 2012. This Committee dealt with technical aspects of health crises while the informal Health Security Committee was more strategically oriented at that time. Our findings suggest that there is still a need to perform such technical preparatory work in the current framework (also see paragraph 51 on the HSC above). Options for organising a group to review public health risk assessments and to explore policy options had also been discussed between the Commission and ECDC at the time of our audit (March 2016). Setting up such a group was deemed necessary to avoid overwhelming the HSC, but no practical arrangements had been proposed or agreed. An EWRS user group or similar body to support and facilitate the work of the EWRS user community for functional and procedural aspects of the system’s daily use and potential requests for changes and upgrades, as well as training, did not exist at the time of the audit. However, similar activities took place in the EWRS Committee until 2012 and Member State representatives for the EWRS identified a continuing need to regularly discuss these issues. In its 2015 implementation report, the Commission stated that it was considering a further upgrade of the EWRS that would in the medium term allow more user-friendly functions to be developed as soon as the proposal for a full reshape (i.e. modernisation) of the EWRS IT tool had been agreed with the stakeholders and ECDC. However, we could not obtain any specific Commission evidence of progress in this context at the time of the audit. Already in 2011, the Commission identified agencies and rapid alert systems at EU level that should be linked to the EWRS. The list included comments on each alert system justifying the need to ensure that alert notifications under the EWRS are linked with them. It identified objectives and gaps to be closed in relation to this interfacing. We examined progress made on this interfacing since 2011 and found that at the time of our audit (March 2016) there was still a list of alert and information systems to be progressively linked with the EWRS. The issue of linking alert systems is important, as different EU alert systems (e.g. Europhyt for plant health or RAPEX for dangerous non-food products) managed by different Commission services may also have different contact points in Member States, making appropriate channelling of communication at national and EU levels essential. According to the Commission, full completion of the (procedural and technical) interfacing activities might not be achieved until there is more clarity on the scope and impact of the ‘full reshape’ of the EWRS IT tool as described in the previous paragraphs. In the meantime, effective procedures still need to be in place to avoid any overlap or duplication of activities and to ensure effective early response to alerts for different threats. Overall, we found that the EWRS has been operational for many years and that its important role at EU level is widely recognised by stakeholders, including EWRS users consulted during our audit. However, the Commission and ECDC had not yet taken substantial action to further enhance the EWRS and develop integrated solutions for situational awareness and incident management for serious cross-border threats to health. In addition, the procedural or technical interfacing with other rapid alert systems at Union level was not yet completed. If a threat is raised in accordance with the alert notification rules of the decision on serious cross-border threats to health, the Commission should make available to the national competent authorities and to the Health Security Committee, through the EWRS, a risk assessment of the potential severity of the threat to public health, including possible public health measures. ECDC should prepare such a risk assessment if the threat concerns a communicable disease, AMR or related special health issues, or is of unknown origin. The European Food Safety Authority and other Union agencies can also be requested by the Commission to provide the risk assessment if appropriate. Where the risk assessment needed is totally or partially outside the mandates of the Union agencies, and it is considered necessary for the coordination of the response at Union level, the Commission should provide an ad hoc risk assessment. We examined how this would work in practice. For chemical and environmental threats, the decision gives full discretion to the Commission to source a rapid risk assessment from any appropriate source. At the time of the audit, rapid risk assessments for chemical threats were sourced from an EU co-funded project. The project developed a comprehensive toolkit to deal with such threats, but came to an end in March 2016. In order to fulfil its legal obligation to provide rapid risk assessments for these threats after that date, the Commission developed a standard operating procedure with its Scientific Committee, which took over some, but not all, of the project’s outputs to provide the required capacity. The frequency of serious cross-border chemical incidents is generally low, but their nature entails that there may be a requirement to deliver rapid risk assessments in timeframes as short as 12-36 hours, and out of office hours. The Scientific Committee did not provide its scientific advice on such a basis before. An exercise held by the same project in 2016 further illustrated the added value of the components of its toolkit for dealing with chemical threats. It showed that once all experts in the Scientific Committee’s Working Group on rapid risk assessment for chemical threats was recruited (the call for experts closed on 9 May 2016), a significant training and exercise effort would most likely be required until this mechanism reached optimal effectiveness to deliver rapid risk assessments of the required quality and within the required timeframes. In addition we found that the hosting of the IT tool developed by the project, for monitoring potential serious chemical incidents before alerting them to the EWRS, had indeed been taken over from the project by the Commission. However, only 14 Member States had registered users at the time of our audit, meaning that there is no full and consistent EU coverage for this type of threat reporting. The Commission did not provide clear evidence of how the platform would be moderated and maintained, or how training and promotion of its use would be organised. The standard operating procedure for rapid risk assessments to be performed by the Scientific Committee only referred to chemical incidents and did not mention environmental threats. We did not identify any other standard operating procedure at the level of the Commission for obtaining rapid risk assessments for serious cross-border environmental threats. Overall there was little EU-level experience in responding to serious cross-border chemical or environmental threats, and the relevant updated monitoring and early response arrangements for such threats were yet to be tested. The Commission should establish and update procedures for the operation of the epidemiological surveillance network as developed in application of specific provisions in the ECDC founding regulation. In addition, when reporting information on epidemiological surveillance, the national competent authorities should, where available, use the case definitions adopted in accordance with the decision for each communicable disease and related special health issue included in an EU list of diseases. The Commission adopts case definitions to ensure data comparability and compatibility at Union level. ECDC hosts and operates the epidemiological surveillance platform TESSy to which Member States upload their surveillance data. Improving the quality of surveillance data collected at a European level constitutes one of ECDC’s objectives in its long-term surveillance strategy for 2014-2020. ECDC’s strategic multiannual programme also states that data quality and comparability across Member States can be increased. ECDC and surveillance experts in the Member States have collaborated to develop surveillance standards in order to streamline EU surveillance and to improve data quality. ECDC considers Member States’ compliance with reporting requirements to be overall satisfactory. However, data quality (completeness and representativeness) is often problematic. ECDC has conducted specific data quality assessments on three diseases to assess quality indicators such as completeness, precision and validity. These assessments have identified multiple shortcomings for these criteria. A project run by ECDC since 2009 devoted to improving the quality of data collected by the national surveillance systems was planned to finish in 2011, but was still ongoing at the end of 2015. Finally, according to ECDC, one of the factors contributing to the data quality issues is the fact that Member States often choose to use other case definitions than the EU case definitions established by a 2012 Commission implementing decision. Overall, we therefore found that ECDC’s efforts to address issues in epidemiological surveillance data reporting have not yet been fully effective to ensure optimal data comparability and quality. Member States could also still improve in this area by consistently using EU-level case definitions and optimising their data delivery to ECDC. We examined whether the EU health programmes are making effective contributions to protecting citizens from threats to health. This included a detailed examination of the management by the Consumer, Health, Agriculture and Food Executive Agency (Chafea) and performance of 20 actions (see Annex III for an overview) funded under the health threats objective of the second health programme (see paragraph 11), including visits to coordinating beneficiaries of seven projects. We also audited the progress of the health threats objective under the current third health programme in terms of relevant actions formulated in the annual work plans and the related performance measuring by the Commission. Overall, we found that the performance of the health programmes, as regards protecting citizens from (serious cross-border) health threats, showed weaknesses. In the following paragraphs we report on the lack of sustainable results for health threat actions under the second health programme (2008-2013) and weaknesses in measuring the indicator for the health threat objective under the third health programme. For the 2014-2016 period we also found a relatively low level of spending on health threat actions, considering the importance and ambition of the relevant objective and available resources. The second health programme should complement, support and add value to the policies of the Member States by protecting and promoting human health and safety and improving public health. The programme has three objectives, one of which is to improve citizens’ health security. Under this objective, the action covered in the scope of this audit is Action 1.1: Protect citizens against health threats. The EU financial regulation requires the budget to be implemented in compliance with the principles of sound financial management (i.e. economy, efficiency and effectiveness). The principle of effectiveness requires attaining the specific objectives set and achieving the intended results. The Commission and Chafea need to ensure that the co-funded actions contribute to achieving the objectives of the health programme. We also consider that results delivered by the funded actions, provided that they are of sufficient quality, should be sustained and promoted after the actions finish, in order to ensure that there is an impact and added value from them. Most of the 14 projects in our sample of 20 actions performed well in terms of producing the agreed deliverables (except for two, which were rated by Chafea as ‘fair’ and failed to produce some of the required deliverables, or to the required quality). However, we found that many deliverables, even if very practical or ready for use (e.g. toolkits, protocols, guides) were not being used after the projects had finished, or no clear demonstration could be provided of how the deliverables influenced policymaking at national or EU levels. For nine out of the 12 completed actions audited we identified significant issues concerning the lack of sustainability of results, which in many cases were also identified in Chafea’s own internal assessment notes prepared at the end of these projects (see Box 5 for examples). In addition, we found that Chafea and/or the Commission give very limited technical feedback on the content of project deliverables and policy relevance when the projects finish. This was also confirmed by the beneficiaries that we visited on the spot. When they finish, Chafea assesses projects’ potential for the broader policy context and the relevance of the action for DG Health and Food Safety’s policy. However, we found that DG Health and Food Safety, despite having access to these Chafea files, does not systematically review the information included in them to assess which role it can play in taking results marked as relevant for its policies further at EU level or enabling a stronger or wider EU impact. During our visits to project coordinators we discussed their concerns that despite significant dissemination activities required under the grant agreement, they find it challenging to reach specific target audiences, in particular EU-level and national level policymakers. Our audit work for one project in the sample showed that part of the project results could not be sustained because the network of specialists using the developed IT platform largely ceased to function after the project ended. We also audited a project with extensive research components, which proved to be overly complex and costly. The main objective of this project was not achieved. This was in part due to the fact that lessons from the project’s predecessor were not duly taken into account and ambitions were therefore set too high. In a third project for screening of a specific disease in certain populations we found that the project was very successful at delivering the required high-quality outputs, but its outputs were not updated further after the project finished, nor widely used. The contributions of these projects to the health programme’s health threats objective would therefore rapidly decrease with time. The ex post evaluation of the health programme listed similar issues saying that even though a considerable effort was made during the second half of the programme to enhance dissemination, there remained room for improvement in terms of raising awareness among relevant stakeholders of the results of co-funded actions, in order to maximise their uptake and impact. In addition, the evaluation report identified that if policy links are absent, it is difficult to overcome barriers for EU-wide implementation of results. According to the same report, not all co-funded actions were particularly effective when it came to achieving tangible and useful results and impacts. While joint actions (see Box 6) typically achieve a tangible impact, the report said, projects relatively often fail to see their results taken forward and put into practice. Among other reasons this was due to insufficient attention being paid to key barriers to implementation and engagement of relevant enablers. As regards the five procurement items (see Annex III) that we audited at DG Health and Food Safety and Chafea, we also identified a limited uptake of outputs and evaluation of results. Recommendations from final activity and evaluation reports for exercises and workshops/trainings were generally not integrated in action plans whose implementation could be monitored. Two exercises (held in 2011 and 2014) included in our sample of five procurement items covered chemical threats and identified many similar and also some identical issues and recommendations. The EU health programme includes an innovative, promising funding instrument called ‘Joint Actions’. These are generally co-financed by competent authorities responsible for health in the Member States. Joint actions’ proposals should provide a genuine European dimension. On average, joint actions have included 25 partners. The fact that joint actions involve or get support from national competent authorities for public health should allow for a better uptake of results and policy impact. However, given their significant size, they take more time to prepare and also require political backing and national co-funding. This means that, despite their potential for increasing the EU-wide take up of outputs produced with health programme funding, there cannot be too many subsequent joint actions in one policy area. Two actions implemented under administrative arrangements with the Joint Research Centre were discontinued after 1 year and 6 years respectively. When the first action for an epidemiological modelling network was discontinued, the Commission did not make an assessment of the action results and did not document its considerations to close the action. The second action continued for 6 years, from 2005 until 2011. It concerned an information exchange platform for public health situations. It was developed at the request of Member States based on discussions within the HSC, but was discontinued in 2012, when the Commission decided to close all existing IT systems that were not integrated in any legal base. Notwithstanding the issues presented above, there is evidently high added value in the audited projects in terms of EU-wide networking and capacity building. All project grants are implemented by consortia of partners, and although the geographical spread in this part of the health programme is not yet optimal and there is a certain concentration of activities with a limited number of national agencies, much experience has been gained. However, the Commission does not take sufficient structured action, in collaboration with its partners, agencies and committees, to optimise the policy feedback loop. This is an issue, in particular because the health programme is a policy driven programme. We found that in the third health programme (2014-2020) (also see paragraphs 89 to 94 below), there was a shift from projects to procurement. This is a different funding mechanism putting the ownership of the outputs with the Commission. However, as already mentioned in the Ex-post evaluation of the second health programme, there is a risk that excessive reliance on service contracts would be detrimental to health programme inclusiveness (in terms of types and geographic spread of beneficiaries). Our audit work for the second health programme showed (see paragraph 84) that also in the area of procurement, Chafea and the Commission could have performed better in ensuring sustainable results. Overall, the sustainability of results is not ensured for most of the audited actions under the health threats action of the second health programme, limiting their contribution towards achieving the objective of protecting citizens from threats to health. The Commission could take more effective action to help beneficiaries in overcoming barriers for targeted dissemination and assessing and promoting the policy relevance of completed actions. The third health programme for Union action in the field of health (2014-2020) covers four specific objectives and indicators, one of which (i.e. Objective 2) addresses serious cross-border threats to health: ‘In order to protect Union citizens from serious cross-border health threats: identify and develop coherent approaches and promote their implementation for better preparedness and coordination in health emergencies’. The objective should be measured through the increase in the number of Member States integrating coherent approaches in the design of their preparedness plans (also see paragraphs 30 to 34). Thus the funded actions should contribute to achieving this specific objective, and methodologies should be in place to effectively measure the progress through the specific indicator. The financial envelope for the implementation of the 2014-2020 programme is 449 million euro. The criteria for establishing annual work programmes say that there should be a balanced distribution of budgetary resources between the different objectives of the programme. We analysed the Commission’s internal multiannual planning established in 2013, and a draft 2016 update which we received during the audit. For Objective 2 activities were initially planned for three out of the four underlying thematic priorities. The budget overview showed that the expected overall amount for the period 2014-2020 for Objective 2, covering all different funding mechanisms, would be 12069000 euro, or 3 % of the total programme amount across all four objectives. Even if the details and potential adjustments of the 2016 review of the indicative multiannual planning and the potential changes for Objective 2 were not yet available at the time of our audit, the evidence showed that fewer actions had been included in the annual work programmes for 2014 and 2015 than were initially planned. Consequently, the programme was not on track to spend the forecast 3 % of the total available resources on Objective 2 by 2020. This casts doubt over whether the relatively low level of spending for this objective is sufficient to achieve this important and ambitious objective, and does not achieve a balanced distribution of budgetary resources between the objectives. We also examined whether there was a clear methodology for measuring the specific indicator associated with Objective 2 (see paragraph 89). Similar to our observation in paragraphs 30 to 34, we could not identify such a methodology. Chafea collects certain information on the implementation of the health programme, in collaboration with the national focal points of the health programme in the Member States, but not with the specific aim of quantifying the progress under this indicator on the basis of projects’ results and outcomes. Although the results of the few actions funded until now under Objective 2 of the third health programme were not assessed in this audit, we find that there is no clear methodology to measure the progress under the relevant specific indicator from the funded actions. Overall, the measuring of the indicator for the third health programme’s objective to protect citizens from serious cross-border threats to health showed weaknesses and there was a relatively low level of spending for this objective in 2014-2016, in any case much lower than for the other main objectives of the programme. This raises concerns over whether a sufficient number of policy-relevant actions to achieve some balance between the objectives, and make a real impact for serious cross-border threats to health, can be funded by 2020. We examined whether the Commission’s internal coordination in terms of health security funding and public health crisis management is adequate. Overall the audit revealed that a number of gaps exist in this internal coordination. The coordination between Commission services for health security funding from different EU programmes does not fully ensure the achievement of synergies. More progress is needed in operationalising the cooperation between Commission crisis management structures and we found weaknesses in the Commission’s management of its Health Emergencies Operations Facility. In order to ensure that health security objectives of the health programmes are achieved in the most efficient way, the work of relevant services at the Commission and its agencies should be effectively coordinated. In implementing the EU budget, the European Commission needs to ensure sound financial management and that the use of EU resources achieves EU added value. The Commission should also, in cooperation with the Member States, ensure overall consistency and complementarity between the programme and other policies, instruments and actions of the Union, including those of the agencies. We analysed a sample of 10 projects funded under the seventh research framework programme (FP7), representing a total level of EU co-funding of approximately 50.8 million euro. We selected projects with a potential relevance to DG Health and Food Safety’s policy area of health security based on an analysis of their objectives, originating from different strands of the FP7 programme (see paragraph 12) and managed by different Commission services or agencies. We reviewed the objectives and scope of the projects, and their complementarity to the relevant health threats objectives of the health programme. DG Health and Food Safety is generally involved in all formal coordination structures and procedures for FP7 and for Horizon 2020, including inter-service consultations for the work plans of Horizon 2020 and for relevant grant award decisions. DG Research and Innovation participates in DG Health and Food Safety consultation procedures for the health programme and the wider policy area and is involved in the evaluation of proposals submitted under the health programme. DG Research and Innovation is also on the ECDC management board. We found that despite the scientific character of FP7 health and security projects, six projects we reviewed showed clear links with certain projects that we examined under the EU health programme. These often focused on preparedness and aimed to produce tangible, policy-relevant outputs. One potential reason is that two of the reviewed projects are so-called coordination and support actions (CSAs). These are actions that do not cover the research itself, but rather coordination and networking, dissemination and use of knowledge, or studies or expert groups assisting the implementation of the programme. The other Commission services interviewed indicated that upon request from policy DGs they can perform analyses of their project portfolios, but DG Health and Food Safety had not requested this for the health threats area. The Commission experience of these research programmes, in particular the security strand of FP7, shows that there is a need to better involve end-users to ensure a better take-up of results, similar to the issues we found in relation to the health programme (paragraphs 79 to 88 above). DG Migration and Home Affairs took the initiative to develop a ‘Community of Users for Disaster Risk and Crisis Management’, which provides a forum for information exchanges between users and other stakeholders. The forum should also facilitate synergies by performing regular surveys of projects from different calls, and by organising ad hoc meetings for exchanging views between policymakers and stakeholders to discuss synergies. A comprehensive mapping of EU-supported actions as part of the community of users is a promising initiative that could potentially be developed for other policy or thematic areas. Projects operating in the same thematic area might be funded from different EU programmes. High volumes of EU funding from different thematic programmes and the involvement of a range of Commission services in their management, requires complex networking between Commission services, national policy makers, end-users and other stakeholders. The risk of overlaps, though minor, persists, and opportunities for achieving more synergies remain. In this context, there is scope for better policy-oriented and structured coordination, in particular for health security policy and related actions. We found that DG Health and Food Safety could do more structured work to facilitate this type of coordination and to allow it to better steer policy feedback and dissemination of relevant results to its own stakeholder group and the HSC. A memorandum of understanding signed in May 2013 by DG Health and Food Safety, DG Migration and Home Affairs and DG European Civil Protection and Humanitarian Aid Operations covers the coordination of their respective crisis management structures. This coordination should encompass cross cutting activities on serious cross-border threats to health in all areas where joint efforts would be of mutual advantage. This includes training and exercises on preparedness, risk assessment and the provision of mutual support during the response phase and when drawing lessons learned after crises. Secured communication channels between the respective crisis centres are also foreseen. The memorandum of understanding was put in place to increase the EU’s capacity to respond to major multi-sector emergencies. However, we found that at the time of the audit, standard operating procedures to implement the agreement were still being developed. Although DG Migration and Home Affairs, DG European Civil Protection and Humanitarian Aid Operations and DG Health and Food Safety have been active in preparing, planning, conducting and utilising the outcomes of a series of joint exercises, we could not obtain evidence at DG Health and Food Safety that there had been systematic joint training sessions, workshops or regular meetings involving key crisis management staff operating the crisis management facilities of DG Health and Food Safety, DG Migration and Home Affairs and DG European Civil Protection and Humanitarian Aid Operations as planned in the agreement. The lack of progress on these issues was to a large extent due to the evolving Ebola crisis, when it was difficult to organise development work. The report on the 2015 Ebola lessons learned conference includes recommendations for actions regarding crisis management at EU level. It stated that cooperation between public health and development aid partners and other key actors at various levels should be enhanced to better coordinate and integrate public health considerations in resilience building and response to emergencies. To this end, common response plans and further joint training, exercises, exchange of best practices and cross-sectoral guidelines should be pursued. According to the report, the Commission’s Emergency Response Coordination Centre should be further developed as an information exchange and coordination platform at EU level for public health crises originating from outside the EU, in close cooperation with the Health Security Committee. Although it was mostly addressed to DG European Civil Protection and Humanitarian Aid Operations which operates the Emergency Response Coordination Centre (ERCC), we did not find, at the time of the audit, a specific action plan for DG Health and Food Safety’s involvement in the follow-up of these recommendations. The memorandum of understanding between the three DGs referred to above is an important step in increasing preparedness at EU level for serious cross-border threats to health and other major multi-sector emergencies. However, our audit work at DG Health and Food Safety showed that more progress is needed to implement this memorandum, notwithstanding the extensive cooperation between DG Health and Food Safety and DG European Civil Protection and Humanitarian Aid Operations during the Ebola outbreak. DG Health and Food Safety operates a Health Emergencies Operations Facility which can be activated at different alert levels in times of a health crisis. We considered that such a facility requires a structured approach to post-event evaluation. Emergency management plans need to be updated in accordance with the recommendations made in a post-event evaluation. Examples of such arrangements can also be found in ECDC’s public health emergency plan and its standard operating procedures. In order to effectively fulfil their role in crisis management and coordination structures, relevant staff members should keep their knowledge of their potential role and systems up to date by participating in training programmes. The relevant organisation needs to monitor its staff’s knowledge and awareness of their potential role, for example by monitoring their effective training participation. Clear and adequate arrangements need to be in place to ensure that an organisation with crisis coordination or management responsibilities can sustain its activities at a heightened state of alert for a prolonged period of time, and staff needs in this respect should be duly taken into account. The Health Emergencies Operations Facility is based on a DG Health and Food Safety manual. This manual had been updated and simplified following the lessons learned from the 2009 H1N1 crisis. Nonetheless, we found a number of significant weaknesses in the Commission’s management of the Health Emergencies Operations Facility. The content of the manual was not up to date at the time of the audit. It was insufficiently clear which parts of the specific recommendations from the major 2014 Quicksilver Exercise had been taken up to improve its design. In addition, the Commission had not performed an internal evaluation of the functioning of the Health Emergencies Operations Facility during the Ebola crisis and the guide was therefore not updated accordingly. We further found that there had not been any continuous training of relevant staff to ensure that they can take up their roles in the Health Emergencies Operations Facility at any given time, in particular when staff members are not part of the Crisis Management and Preparedness Unit but could be called for duty if the highest alert level is raised. Concerning staffing during periods of increased alert, we found that only regular compensation arrangements within the flexitime regime were in place, which are not adequate to address the challenges faced by DG Health and Food Safety in coordinating the management of public health emergencies at EU level, in particular when the emergency lasts for a long period of time and staff work in shifts without opportunities for taking compensatory leave. We also found that the Health Emergencies Operations Facility had not been ‘peer reviewed’ by any other institution or agency, and that no specific exchanges of experiences or best practices in relation to the design and operation of their respective emergency management plans had been carried out between ECDC and DG Health and Food Safety. The entry into force of Decision No 1082/2013/EU on serious cross-border threats to health contributes to building and strengthening a comprehensive EU framework for health security, and for enabling the Union to protect its citizens from such threats. Developing and implementing this decision and related EU-level health security actions, including funding programmes, is a complex matter due to the multitude of actors and complex structures in place within countries and in the international context (see Annexes I and II), as well as from a legal perspective. The Member States have the main responsibility for health policy (see paragraph 3), and EU action in this area is only designed to complement and support Member States’ activities. The Commission’s role and responsibility therefore consist mostly of providing support and taking complementary action where needed. To add to the complexity, a relatively high frequency of serious emergencies requires almost constant attention. There have been several such emergencies since the adoption of the decision and new threats could materialise quickly, including a major pandemic influenza hitting the EU. This means that there is an almost continuous need for Member States, the various relevant Commission services and international organisations to be engaged in response actions while still continuing substantial remaining work on preparedness. Against this challenging background, the existence of the decision in itself, and measures and programmes to support its implementation, is not enough to ensure optimal protection of citizens from serious cross-border threats to health in the EU. Moreover, the decision is an EU law whose rules need to be applied effectively and consistently by all involved to ensure that its objectives can be met. We therefore assessed whether the EU framework for protecting citizens from serious-cross-border threats to health was adequately implemented. In doing so, we focused on the effective implementation of the innovative and previously existing areas of the decision (paragraphs 7 to 9). We also addressed the questions whether the EU health programmes were making effective contributions to protecting citizens from threats to health and whether the Commission’s internal coordination in terms of health security funding and public health crisis management was adequate (paragraphs 15 and 17). Our overall conclusion is that Decision No 1082/2013/EU on serious cross-border threats to health represents an important step for dealing better with such threats in the EU. However, significant weaknesses at the level of the Member States and the Commission affect the implementation of the decision and the related EU framework. While the nature and scale of future threats is unknown and may evolve, more needs to be done to address these weaknesses and allow the Union to take full benefit from its established mechanisms. We found that the implementation and development of the innovations introduced by the decision on serious cross-border threats to health (paragraph 21) since its entry into force in December 2013 were hampered by delays, potentially reducing their effective functioning. The consultation between Member States and the Commission on preparedness and response planning for serious cross-border threats to health has been initiated as required. However, the procedures for obtaining and exchanging relevant information with a view to better coordinating efforts in relation to preparedness are not yet sufficiently robust and have not yet delivered clear-cut results (paragraphs 22 to 29). As regards the Commission’s measurement of performance for the implementation of the cross-border health threats policy area, we found that key elements of the Commission’s specific objective and indicator are not clearly defined and agreed with the Member States, to ensure that all stakeholders work towards the same objectives (paragraphs 30 to 34). We further found that: ECDC’s role in relation to generic preparedness is insufficiently formalised, which may limit its capacity to properly plan its related tasks in the long term or respond effectively to assistance requests (paragraphs 35 to 39); Member States have shown insufficient responsiveness to speed up the joint procurement of pandemic influenza vaccine (paragraphs 40 to 43); and the EU does not have a mechanism to address urgent needs for medical countermeasures within the framework of the decision on serious cross-border threats to health (paragraph 42). Finally, the work and role of the HSC have proven to be very important, but it is facing some strategic and operational challenges which need to be tackled to enable it to make full use of its strong mandate (paragraphs 44 to 52) and thereby ensure the highest possible level of protection against health threats in the EU; this also relates to ensuring that the decision’s coordination of response rules can be applied effectively (paragraphs 53 to 55). It is necessary to speed up the development and implementation of the innovations introduced by the decision, and tackle the remaining operational and strategic challenges for the HSC. This requires a better common understanding between Member States and the Commission of the objectives and joint priorities for the enhanced coordination and information exchange efforts under the decision, in particular in the areas of preparedness planning, joint procurement and organising the work of the HSC in the long term. For preparedness and response planning, an additional challenge is to consider the developments occurring in the wider international context as outlined in Box 3 and Annex I. In order to speed up the development and implementation of the innovations introduced by the decision on serious cross-border threats to health, and tackle the remaining operational and strategic challenges for the HSC:

(a) The Commissionshould propose to the HSC that it develop a strategic HSC roadmap for the implementation and development of the decision. While the decision does not require the setting of targets and indicators, this roadmap should reflect joint priorities, in particular on the coordination of preparedness planning, to facilitate a common understanding of how to achieve more clear-cut results towards 2020. Work in this area should take account of the international initiatives in this domain which in particular call for peer review or external assessment mechanisms to be applied. If possible, this work should also take account of preparedness guidance already developed at EU level.

(b) The Commission should ensure that lessons learned from the first reporting cycle on preparedness planning are applied for the next round of reporting in 2017 and improve its performance reporting for the implementation of the decision towards 2020. It should ensure that reported progress is accurate and based on methodologies agreed with the Member States where relevant.

(c) The Commission, in cooperation with the Member States, should identify how to best make use of the HSC working groups and ensure that their work is well structured around technical issues and serves as an input to the HSC. Working groups already established need to apply their terms of reference from 2017 and deliver results, based on annual work plans and clearly identified objectives. This also applies to the HSC preparedness working group and its work to develop an EU mechanism to address urgent needs for medical countermeasures.

(d) The Commission and the Member States need to ensure that the work on the joint procurement of pandemic influenza vaccine accelerates and delivers results as soon as possible.

As regards the effective implementation of the existing systems for early warning and response and epidemiological surveillance (paragraph 56), for which the decision on serious cross-border threats to health provides the legal basis, we found overall that these systems have been operational for years and that their important role at EU level is widely recognised by stakeholders. However, for early warning and response we found that there is scope for making upgrades to the EWRS, including to related procedures and processes for situational awareness and incident management and the organisation of the EWRS user community (paragraphs 57 to 68). In addition, the updated EU-level approach to early warning and response for serious chemical and environmental threats was not yet tested (paragraphs 69 to 73). Finally, the epidemiological surveillance system generally works well, but further work by ECDC and the Member States is required to ensure maximum comparability and quality of surveillance data (paragraphs 74 to 77). In order to further upgrade the EWRS and develop more integrated solutions for related risk management procedures, the Commission, in cooperation with the Member States and ECDC, should:

(a) examine and propose in 2017 options for modernising and enhancing the EWRS. This should include integrated or complementary options for EU-level situational awareness and incident management for serious cross-border threats to health;

(b) obtain regular feedback from users on integrated solutions for risk management and the operation and development of the EWRS.

As regards the health programme objectives to protect citizens from (serious cross-border) threats to health (paragraph 78), we found that its performance showed weaknesses. Most of the audited health threat actions from the second health programme (2008-2013), despite performing well in terms of producing the agreed deliverables, showed a lack of sustainable results (paragraphs 79 to 88), limiting their contribution towards achieving the objective of protecting citizens from threats to health. Although this is not a new observation, it underlines that the Commission needs to do more, in consultation with its stakeholders, to improve performance on this issue. In addition, we found weaknesses in measuring the indicator for the health threats objective under the third health programme as well as a relatively low level of spending for this particular objective in 2014-2016, suggesting that it is difficult to fund a sufficient number of policy relevant actions under this objective to ensure that a real impact is made towards 2020 in achieving the objective (paragraphs 89 to 94). In order to address the main weaknesses identified in the performance of the health programme for actions addressing health threats, the Commission should:

(a) examine and propose options in 2017 for ensuring a greater sustainability of results for health threat-related actions funded under the health programme towards 2020. These should include stronger needs and policy relevance identifications when programming actions, but also a more collaborative analysis between DG Health and Food Safety and Chafea of the policy relevance of ongoing and recently completed actions with a view to identifying options to promote the uptake of good-quality results (also see Recommendation 4);

(b) define and agree, in consultation with the Member States, a clear methodology for collecting performance information needed to report progress towards 2020 under the specific indicator for health threats in the third health programme (also see Recommendation 1).

(c) clearly identify in 2017, for the remaining years of the health programme until 2020, which priorities under the objective to protect citizens from serious cross-border threats to health provide opportunities for funding policy-relevant actions towards 2020 (see Recommendation 3(a).

Finally, the audit revealed that, despite a wide array of coordination mechanisms, a number of gaps exist in relation to the Commission’s internal coordination of health security activities across different services and programmes to ensure that full use is made of potential synergies. In a context of high volumes of EU funding from different thematic programmes and a range of Commission services being involved in their implementation, requiring complex networking between Commission services, national policymakers, end-users and other stakeholders, there is scope for better policy-oriented and structured coordination (paragraphs 96 to 102). We also found that more work needs to be done to make existing agreements for cooperation between Commission crisis management structures fully operational (paragraphs 103 to 106), and that DG Health and Food Safety’s management of its Health Emergencies Operations Facility showed weaknesses that might hamper its performance when dealing with future health crises in the EU (paragraphs 107 to 111). In order to bridge the gaps in the Commission’s internal coordination in terms of activities relevant to health security and public health crisis management, and to improve the design of its Health Emergencies Operations Facility:

(a)the Commission should define from 2017 a more structured, detailed approach for coordination between DG Health and Food Safety and other Commission services which perform activities relevant to health security, including a mapping of past, ongoing and planned activities. This should allow for the identification of potential synergies and enhance cooperation on common issues such as the limited uptake of outputs for EU co-funded actions and enabling stakeholders to better target policymakers;

(b) the Commission should take immediate action to operationalise the memorandum of understanding for crisis management structures between DG Health and Food Safety, DG Migration and Home Affairs and DG European Civil Protection and Humanitarian Aid Operations; this includes organising joint lessons learned activities and mutual training on policy areas and systems, as well as putting in place standard operating procedures;

(c) the Commission should without delay review its Health Emergencies Operational Facility and ensure that: it is updated in line with lessons learned from the Ebola crisis and major EU-level exercises; a continuous monitored training plan is in place for all relevant staff potentially involved in its operations; and, if possible, exchange views with ECDC and DG European Civil Protection and Humanitarian Aid Operations, in particular on the design of their respective crisis management manuals or structures.

This Report was adopted by Chamber I, headed by Mr Phil WYNN OWEN, Member of the Court of Auditors, in Luxembourg at its meeting of 5 October 2016. For the Court of Auditors Klaus-Heiner Lehne President

ANNEX

ANNEX I PREPAREDNESS AND RESPONSE PLANNING IN THE INTERNATIONAL CONTEXT

INTERNATIONAL HEALTH REGULATIONS 2005 (IHR 2005) 1.2.

The 1969 WHO International Health Regulations were fully revised and replaced by the IHR (2005), which entered into force in 2007. The IHR objective is ‘to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade’ . The IHR 2005 requires State Parties to report to WHO any event that may constitute a public health emergency of international concern, independently of its origin, and to develop, strengthen and maintain core public health capacities for surveillance and response by using existing national resources, such as the national plans for influenza pandemic preparedness. The IHR are also designed to reduce the risk of disease spread at international airports, ports and ground crossings and require the establishment of national and WHO IHR focal points for urgent communication. The IHR (2005) do not include any enforcement mechanism for States which fail to comply with its provisions. WHO monitors the implementation of the IHR, and issues and updates relevant guidelines. Its expert panels and review committees also review IHR effectiveness in emergency situations, as was done, for example, after the Ebola outbreak (see Box 3 in the report for more information on this).

PUBLIC HEALTH EMERGENCIES OF INTERNATIONAL CONCERN (PHEIC) 3.

Under the IHR, a public health emergency of international concern refers to an extraordinary public health event which constitutes a public health risk to other States through the international spread of disease and potentially requires a coordinated international response. The PHEIC is declared by the director-general of WHO based on a recommendation from the Emergency Committee. If a PHEIC is declared, WHO is required to deliver a ‘real time’ response to the emergency. The Director-General of WHO, assisted by the Emergency Committee, will develop and recommend the critical health measures for implementation by State Parties.

THE IHR AND THE EU 4.

All EU Member States are State Parties to WHO and report to WHO, for example through questionnaires and self-assessments, on their IHR implementation. The EU itself is not a WHO member, and therefore is not a party to the IHR. However, the IHR recognises the potential role of the EU as a ‘regional economic integration organization’ and states that, ‘without prejudice to their obligations under these Regulations, States Parties that are members of a regional economic integration organization shall apply in their mutual relations the common rules in force in that regional economic integration organization’. The Commission and ECDC coordinate their activities with WHO at policy and technical level, including information sharing for risk communication and read access to certain alert systems (such as the WHO Event Information System and the EU’s EWRS). Decision No 1082/2013/EU also introduced the innovation of a public health emergency declaration by the Commission, but it is significantly different from a PHEIC declaration by the Director-General of WHO (see Box A).

BOX A PUBLIC HEALTH EMERGENCY DECLARATION IN THE EU

As explained above, the term Public Health Emergency of International Concern is defined in the International Health Regulations as ‘an extraordinary event which is determined, as provided in these Regulations: to constitute a public health risk to other States through the international spread of disease; and to potentially require a coordinated international response’. The responsibility of determining whether an event is within this category lies with the WHO Director-General and requires the convening of a committee of experts — the IHR Emergency Committee. One of the innovations of Decision No 1082/2013/EU is that the Commission can now also declare a situation of public health emergency for the EU. In accordance with Article 12, the Commission may recognise a situation of public health emergency in relation to: (a) epidemics of human influenza considered to have pandemic potential, where the Director-General of WHO has been informed and has not yet adopted a decision declaring a situation of pandemic influenza in accordance with the applicable rules of WHO; or (b) cases other than that referred to in point (a) where the Director-General of WHO has been informed and has not yet adopted a decision declaring a public health emergency of international concern in accordance with the IHR, and where: Article 13 then adds that this recognition of an emergency situation pursuant to Article 12 shall have the sole legal effect of enabling point 2 of Article 2 of Regulation (EC) No 507/2006 to apply or, where the recognition specifically concerns epidemics of human influenza considered as having a pandemic potential, of enabling Article 21 of Regulation (EC) No 1234/2008 to apply. This means that the purpose of emergency declaration under Article 12 of Decision No 1082/2013/EU is restricted only to a fast track authorisation for pandemic medical countermeasures and operationalising pharmaceutical legislation. Its application is much more limited compared to a declaration of a Public Health Emergency of International Concern by WHO, even though situations could occur where a serious cross-border threat to health, from any potential origin, specifically affects the EU and not necessarily the wider global community for which WHO is responsible. It also means that there is no EU scale of alert levels (e.g. linked to the rules of procedure of the Health Security Committee) triggering response activities and capacities within the remit of the decision or to ensure the triggering of a mechanism for surge capacity or funding.

(i) the serious cross-border threat to health in question endangers public health at the Union level;

(ii) medical needs are unmet in relation to that threat, which means that no satisfactory method of diagnosis, prevention or treatment is authorised in the Union or, despite the existence of such a method, the authorisation of a medicinal product would nonetheless be of major therapeutic advantage to those affected’.

INTERNATIONAL INITIATIVES ON PREPAREDNESS PLANNING AND TRANSPARENCY 5.

There are also several other international initiatives addressing the need to enhance preparedness planning and increase transparency. These initiatives mainly include the Global Health Security Agenda initiative to perform ‘peer reviews’ and the G7 and Global Health Security Initiative support to these activities, as well as ECDC country visits that occur on a voluntary basis and where preparedness is also addressed . The report on the conference ‘Lessons learned for public health from the Ebola outbreak in west Africa — how to improve preparedness and response in the EU for future outbreaks’, which fed into the Council conclusions of December 2015, included the following recommendation: ‘A peer-review mechanism could help Member States to improve their national preparedness plans taking into account past and current initiatives on independent country evaluations on global and regional level.’

ANNEX II DESCRIPTION OF MAIN ROLES AND RESPONSIBILITIES IN THE EU FRAMEWORK FOR PROTECTING CITIZENS AGAINST SERIOUS CROSS-BORDER THREATS TO HEALTH

Member State public health authorities 1.2.

Member State public health authorities are responsible for public health policy at national level, and for dealing with public health threats. Differences in responsibilities for certain aspects of preparedness and response planning and early warning and response might exist between Member States, involving different public authorities, depending on their government organisation, national risks or specific situations. Some Member States may have decentralised parts or most of the public health responsibilities, including those for preparedness and response planning. EU Member States are also members of the WHO Europe Region and have an obligation to implement the International Health Regulations as explained in Annex I. Since the adoption of Decision No 1082/2013/EU,Member States also have an obligation to provide certain information on their preparedness and response planning to the Commission. Decision No 1082/2013/EU requires Member States and the Commission to consult each other in the Health Security Committee to develop, strengthen and maintain their capacities for the monitoring, early warning and assessment of, and response to, serious cross-border threats to health. That consultation is aimed at sharing best practice and experience in preparedness and response planning; promoting the interoperability of national preparedness planning; addressing the intersectoral dimension of preparedness and response planning at Union level; and supporting the implementation of core capacity requirements for surveillance and response as referred to in the IHR. Member States also appoint national competent authorities for epidemiological surveillance that are responsible for delivering data to the European surveillance system in accordance with EU rules and guidance, and nominate national EWRS contacts to monitor EWRS and notify alerts, under the rules set out in the decision.

EUROPEAN COMMISSION — DG HEALTH AND FOOD SAFETY 3.

The Commission ensures the secretariat and presidency of the Health Security Committee and coordinates and operates its Health Emergency Operations Facility (HEOF). It also manages relevant IT systems and coordinates with other Commission services and agencies for cross-cutting issues in this policy area, as well as with relevant international organisations, such as WHO. Decision No 1082/2013/EU on serious cross-border threats to health specifically provides that the Commission (i.e. DG Health and Food Safety), in liaison with the Member States, ensures coordination and exchange of information between the mechanisms, structures and activities which are relevant to preparedness and response planning, monitoring, early warning of and combating serious cross-border threats to health. The Commission is also responsible for ensuring that any duplication of activities or conflicting actions is avoided, and that adequate resources are made available for all its required and critical tasks and functions.

EUROPEAN CENTRE FOR DISEASE CONTROL AND PREVENTION (ECDC) 4.5.

ECDC operates and coordinates the network for epidemiological surveillance of communicable diseases and of antimicrobial resistance and healthcare-associated infections related to communicable diseases. It is an EU agency with the mission to identify, assess and communicate current and emerging threats to human health posed by infectious diseases. ECDC also hosts the operation of the Early Warning and Response System (EWRS). EWRS is a web-based system linking the Commission, public health authorities in Member States responsible for measures to control communicable diseases and ECDC. EEA countries (Iceland, Liechtenstein and Norway) are also linked to the system and WHO has read access. Under the decision on serious cross-border threats to health, ECDC is required to provide scientific advice and risk assessments concerning threats that are alerted through the EWRS, in particular for threats of biological or unknown origin. Other EU agencies or bodies (e.g. scientific committees) might be requested by the Commission to provide rapid risk assessments when their expertise is closer linked to the type of threat at hand. When requested, ECDC further assists the Commission and the Member States in implementing Decision No 1082/2013/EU requirements for preparedness planning. The annual budget of ECDC also covers disease programmes; these are vertical programmes for specific diseases, which also have components such as capacity building and risk communication. ECDC can provide outbreak response support to countries or international organisations like WHO, as it did during the Ebola outbreak. It operates an emergency operations centre, based on a public health emergency manual. The current ECDC approach is to target all hazards (i.e. not just threats to health from communicable diseases, but also from other origins), aligned with the objectives of the IHR and Decision No 1082/2013/EU. This is beyond ECDC’s previous, traditional mandate that focused on communicable diseases and pandemic preparedness.

ANNEX III OVERVIEW OF AUDITED CO-FUNDED ACTIONS

The following table provides a list with key features of the audited actions, co-funded under the health threats objective of the second EU health programme 2008-2013, managed by Chafea or DG Health and Food Safety (for three procurement items). Ref. General description Funding instrument EU co-funding as per grant agreement (euro) 1 Developing a generic framework for the fast production and evaluation of emergency vaccines Project 2116023 2 Optimising testing and linkage to care for HIV across Europe Project 1429984 3 A network for the control of public health threats and other bio-security risks in the Mediterranean region and Balkans Project 900000 4 Screening for Hepatitis B and C among migrants in the European Union Project 800000 5 Syndromic surveillance survey, assessment towards guidelines for Europe Project 798814 6 Public health adaptation strategies to extreme weather events Project 750000 7 Empowering civil society and public health system to fight tuberculosis epidemic among vulnerable groups Project 750000 8 Cost-effectiveness assessment of European human influenza pandemic alert and response strategies Project 700000 9 A European network on cervical cancer surveillance and control in the new Member States Project 615023 10 Promotion of Immunisation for health professionals in Europe Project 604000 11 Coordinated action in the aviation sector to control public health threats Project 598566 12 Promote vaccinations among migrant populations in Europe Project 548680 13 Alerting, Surveillance and Reporting System for Chemical Health Threats, Phase III Project 497760 14 European Chemical Emergency Network Project 447600 15 Quality assurance exercises and networking on the detection of highly infectious pathogens Joint action 3316326 16 Command post exercise on serious cross-border threats to health falling under the chemical and environmental categories Procurement/service contract 458989 17 Organisation of two regional training seminars with Member State public health authorities relating to the implementation of the new decision on serious cross-border threats to health. Procurement/service contract 249599 18 Early alerting and reporting system, Hedis, Nemo (monitoring information exchange mechanisms for crisis management) Procurement/service contract 1588500 19 The European reference laboratory system for human pathogens Procurement/service contract 500000 20 Organisation of training of staff and conducting exercises at European level as a fundamental element of preparedness Procurement/service contract 333646 Total : 18003510 The following table provides a list with key features of the reviewed actions, co-funded under the seventh framework programme for research (FP7) 2008-2013. Ref. General objective of the selected action Funded under FP7 programme Responsible Commission service EU co-funding (euro) 1 Forecasting epidemic evolution and pandemic simulations ERC ERCEA 684000 2 Platform for emerging and re-emerging infectious disease entities HEALTH RTD 11909560 3 Infection control in aviation, ranging from effective quarantine to protocols for sanitizing/decontaminating the airliner cabin PEOPLE REA 100000 4 To develop an evidence-based behavioural and communication package for health professionals and agencies throughout Europe in case of major outbreaks HEALTH RTD 1999607 5 The role of pharmaceutical companies in the formulation and implementation of health security policy ERC ERCEA 1197694 6 Transform Europe’s response to future severe epidemics or pandemics by providing infrastructure, coordination and integration of existing clinical research networks HEALTH RTD 23992375 7 Create an integrated toolbox to aid transport operators and relevant actors in major transport hubs in the development of their current pandemic and dangerous pathogen preparedness and response plans SEC HOME 3142004 8 Interoperability and preparedness of European health services in relation to deadly threats such as pandemic disease and major terrorism attack SEC REA 2789940 9 To increase preparedness to large-scale and cross-border disasters amongst communities and societies in Europe. SEC REA 999084 10 To address effectively scientific and societal challenges raised by pandemics and associated crisis management. To develop an integrated, transdisciplinary, strategy. SiS RTD 3939880 Total : 50754144

Versions

1. 2016-12-05