EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY. Flash report from the Plenary Meeting of the Health Security Committee

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1 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Public health, country knowledge, crisis management Crisis management and preparedness in health Luxembourg, 9 th of June 2016 Flash report from the Plenary Meeting of the Health Security Committee on the 7 th and 8 th of June 2016 On the 7 th and 8 th of June, the plenary meeting of the Health Security Committee (HSC) took place at Château de Senningen in Luxembourg. The agenda included topics on current health threats, including Zika and yellow fever outbreak, preparedness and IHR implementation, vaccine shortages, joint procurement of medical countermeasures, antimicrobial resistance, EU action on hybrid threats and lessons learnt from the Paris terrorist attacks. Twenty-five EU Member States and Norway attended the meeting as well as colleagues from the European Commission Directorate-General Informatics (DG DIGIT) and Humanitarian Aid and Civil Protection (DG ECHO), the European Centre for Disease Prevention and Control (ECDC), and the Regional Office for Europe of the World Health Organisation (WHO-EURO). In the evening of 7 June a working visit to Belval took place, including a reception at the University opened by the Luxembourgish Minister of Health, Mrs Mutch and the Vice- President for Academic Affairs of the University, Prof. Tschirhart. 1. WELCOME AND ADOPTION OF AGENDA The Chair, John F. Ryan, Acting Director for Directorate C Public health, country knowledge, crisis management, in Directorate-General Health and Food Safety of the European Commission, welcomed the HSC members and outlined the agenda. The agenda was adopted with one point suggested on migrant health under AOB. The minutes of the previous meeting were adopted without modification. 2. CURRENT HEALTH THREATS ZIKA VIRUS EPIDEMIC ECDC gave a presentation on current health threats, including the state of the Zika virus epidemic. The number of cases is increasing; more than cases were reported in EU EU s Outermost Regions and Territories. With the upcoming Olympic Games in Brazil and the start of the mosquito season in Europe, there is a general concern that the virus would spread in Europe. So far, 728 imported cases have been reported in 19 EU/EEA countries, 41 of these are pregnant women, no autochthonous transmission has yet recorded. The occurrence of sporadic local cases is possible in the EU, with significant risk of transmission in Madeira. 1

2 A yellow fever outbreak is taking place in Africa, with cases of yellow fever reported in Angola in the past 6 months. The risk for it to be spread to the EU is limited, except for Madeira because of the presence of the Aedes aegypti mosquitoes. The first EMC team was deployed in Angola under the leadership of ECDC. ECDC further informed about the plasmid mediated colistin-resistance mechanism MCR-1 in gram-negative bacteria, found in a patient in the US. This mechanism of resistance can be horizontally transmitted allowing interspecies/ interstrain transfer. Importantly, colistin is a last-resort antibiotic used to treat multidrug-resistant infections. The development of colistin resistance will further severely limit treatment options, and even potentially result in untreatable infections. ECDC will finalise the rapid risk assessment on this subject that will be released next week. The Chair provided an update on the activities of the HSC to review the situation and discuss options for mitigating actions with regards to the Zika virus outbreak. The HSC has agreed on the Protocol for surveillance and on the draft case definition. Furthermore, the HSC has reviewed updated risk assessments, information to travellers, guidance for healthcare providers and other technical documents. An ad-hoc working group on the Zika virus outbreak was set up and met on 22 April to review and discuss the information to travellers and disinsectation of aircrafts. Follow up DG SANTE will organize three meetings on June in Luxembourg with health professionals, the transport sector and representatives from the tourism sector to discuss possible measures to prevent the introduction of Zika virus infected mosquitos to Europe. The outcome of these meetings will feed into a meeting on vector control on the 8th of July in Luxembourg. HSC members are invited to participate in the meetings. A WHO regional technical consultation on Zika virus will be held in Lisbon, Portugal, on June 2016, bringing together countries of the WHO European Region in which the likelihood of Zika virus spread is high or moderate. 3. PREPAREDNESS AND IHR IMPLEMENTATION Follow up from the High Level Conference on Global Health Security The Chair provided a summary on the High Level Conference on Global Health Security in March organised jointly by the French Ministry of Health and the Commission, with patronage of the Netherlands Presidency of the Council and WHO. The conference examined how the global health security framework can be strengthened in the context of the review of the IHR. The draft recommendations of the IHR Review Committee were presented by the Chair of the Committee, Prof Didier Houssin. The Chair summary reflected the conclusions drawn by Commissioner Andriukaitis and Ms Touraine, the French Minister for Social Affairs and Health, and was discussed with the Health Security Committee. The Recommendations of the Review Committee on the role of the IHR in the Ebola outbreak and response were the subject of a discussion at the 2016 World Health Assembly in May,

3 IHR Review Committee recommendations and IHR implementation WHO-EURO provided an overview on the state of play of IHR review and implementation. The IHR Review Committee had stressed the importance of implementing rather than amending IHR. As an outcome of the 69th World health Assembly, a request was made to the WHO Director-General to develop a draft global implementation plan for the recommendations of the Review Committee that includes immediate planning to improve delivery of the IHR by reinforcing existing approaches, and indicates a way forward for dealing with new proposals that require further Member State technical discussions. Several lessons learnt regarding IHR implementation (collaboration, assistance, information sharing and communication were shared. The WHO's priorities and planned actions to strengthen regional preparedness were discussed based on several elements: a unified programme ( WHO reform ), all-hazard approach and intersectional engagement, epidemic intelligence through improved communication, promoting IHR tools for detection and risk assessment and mutual support. The IHR monitoring and evaluation framework was briefly introduced based on mandatory annual reporting as well as voluntary after action reviews, simulation exercises and external evaluations. The state of play with Joint External Evaluation tool was also discussed. Member States discussed the Joint External Evaluation approach and the potential role of the Lyon office and of national focal points. The Chair emphasised the importance of defining a long term approach to fully implement IHR in the EU, and to allocate the necessary resources. He also reaffirmed the EU's commitment to support IHR implementation in collaboration with other Commission services, particularly in respect of third countries. It was agreed that WHO efforts and EU action to implement Decision 1082/2013/EU on serious cross-border threats should be coordinated. Plan of Action to strengthen preparedness in the EU and support IHR implementation The Chair provided information on the state of play with regard to the action plan to strengthen preparedness in the EU and support the implementation of IHR, in light of the new developments of the WHO emergency reform and approach to IHR implementation. The Action Plan will also build upon the already identified lessons learnt from the Ebola outbreak and on the findings of the report on preparedness reporting under Article 4 of Decision 1082/2013/EU. The draft action plan will be discussed within the Working Group on Preparedness and presented to the HSC at its next plenary meeting in November. SOP on a voluntary mechanism of the exchange of medical countermeasures The Chair informed that as agreed by the Health Security Committee (HSC), the Working Group on Preparedness and Response Planning has been working on developing SOP to exchange medical countermeasures, for endorsement to the HSC. 3

4 The objective of such SOP is to ensure that Member States have an option to offer rapid mutual assistance on a voluntary basis, in case of shortages or need in case of an emergency, strengthening the implementation of Decision 1082/2013/EU on serious cross-border threats to health. The document has been discussed within the Drafting Group, and within the Working Group on Preparedness and Response Planning in recent meetings. The document will be finalized in July and discussed by the Health Security Committee. Yellow fever outbreak and the mission of the European Medical Corps in Angola DG ECHO presented the recent mission of the European Medical Corps in Angola (EMC). EMC was mobilized with the aim of better understanding the outbreak and analyzing the risk for Europeans. MS are contributing to EMC with their available means. Member States' commitment of resources to the EMC was further discussed, and a need for continued cooperation, regular update to the HSC, and alignment of activities under Decision 1082/2013/EU were acknowledged. 4. LESSONS LEARNT FROM THE PARIS TERRORIST ATTACKS A presentation on the lessons from the Paris terrorist attacks was provided by France. The importance of pre-existing emergency plans and coordination (in hospitals and emergency bodies) as well as damage control practices were emphasised for the success of the response to these massive events. Member States were overall very interested in the summary and lessons learnt from the attacks. France agreed to share expertise and training manuals on damage control techniques for emergency teams. The Chair proposed to organize targeted trainings for Member States on how to train emergency staff, and to plan actions in discussion with France. 5. VACCINE SHORTAGES SANTE provided an update on the state of play of work on vaccine shortages and the findings of an ad hoc audio expert meeting that took place on 3 June. In an open session of that meeting representatives from Vaccines Europe offered technical support (e.g. support to Official Medicines Control Laboratories) in order to shorten timelines as regards release of products. In a closed session of this expert meeting the discussion on the draft concept paper on vaccine shortages focused on possible actions regarding vaccine demand forecasting and vaccine research and development forecasting. 4

5 SANTE will further revise content and structure of the draft concept paper and circulate a revised document for comments to participants in a written procedure by end of June. It is intended to finalize the concept paper in another ad hoc expert meeting after the summer break, aiming to agree on actions to be proposed to the HSC. 6. IMPLEMENTATION OF THE JOINT PROCUREMENT OF MEDICAL COUNTERMEASURES SANTE provided with an update on the implementation of the Joint Procurement Agreement (JPA). Following the signature by Germany of the JPA, last April, the number of the MS who signed the JPA increased to 24 MS and more MS are interested to joining. The call for tenders for Personal Protective Equipment is ongoing, and discussions on new tenders for pandemic vaccines, BCG vaccine against TB & Tuberculin, Diphtheria & Botulinum anti-toxins and hepatitis C treatments are underway. Regarding the procurement of pandemic vaccines almost all participating MS have nominated their representative to the Steering Committee, Germany, Spain, the Netherlands, Hungary and Slovakia provided their needs analysis, other participating Member States not yet. The Chair reiterated that the Commission is at the disposal of the MS and stressed that MS should precisely forecast their needs and timely inform the Commission to ensure a maximum efficiency of the mechanism of JP. 7. ANTIMICROBIAL RESISTANCE (AMR) The Netherlands informed that AMR is a priority for their Presidency, the draft Council Conclusions on AMR will be submitted for adoption by Ministers at the EPSCO meeting on 17 June SANTE gave an overview of the current and new EU activities on AMR including the preparation of EU guidelines on the prudent use of antimicrobials in human medicine, the proposal for a Joint Action on AMR , and the finalisation of the 3rd report on the implementation of the Council recommendation on prudent use of antimicrobial agents in human medicine. ECDC presented a technical report on EU AMR surveillance systems in human health and options for strengthening these systems. It was concluded that HSC should continue to be very actively concerned with AMR and would need to consider further action in the light of the forthcoming Council Conclusions on AMR, preparations of the UN special session on AMR and preparations for future EU initiatives on AMR. On AMR surveillance; issues which merit further work by SANTE and ECDC in collaboration with Member States include: improving the timeliness of information on serious AMR events with cross border implications; more precision on what resistant infections or AMR events it would be useful to have 5

6 quickly reported; and in certain areas what could be done to improve coverage and quality of the AMR surveillance.as a next step discussion should take place at the ECDC Advisory Forum on the basis of a paper to be prepared by ECDC. The prepublication draft of the 3rd report on the implementation of the Council recommendation on prudent use of antimicrobial agents in human medicine will be circulated to Members for final comments AMR will be on the agenda of the next meeting of the HSC in November, to include discussion of EU guidelines on prudent use of antimicrobials in human medicine. The deadline for registering nominations for participating at the Joint Action on AMR is 16 of June. Members of the HSC were asked to liaise within their administrations in order to arrange for nominations of organisations to take part. 8. HYBRID THREATS The Chair presented briefly the objectives of the Joint Framework of the European Commission and of the High Representative, adopted on 6 April 2016, to counter hybrid threats, and foster the resilience of the EU, its MS and partner countries. Hybrid threats refer to mixture of activities often combining conventional and unconventional methods designed to cause direct damage and exploit vulnerabilities, but also to destabilise societies. He underlined that work towards implementing the operational actions of the Joint Framework is underway and an exchange of views within the HSC at this stage was considered very important. DG DIGIT gave a presentation on the current cyber threats in the health sector focusing, particularly, on recent cyber-attacks to hospitals which had a major disruptive impact on hospital services. Participants were invited to the CERT-EU Conference (Computer Emergency Response Team, DG DIGIT) on 6-7 September and the OASIS Borderless Cyber Europe 2016 on 8-9 September and members of the Preparedness Working Group are encouraged to attend. Commission will include hybrid threats in its future exercises to test preparedness and response aspects caused by hybrid threats. 9. AOB Migrant health Cyprus and Greece asked that migrant health is discussed under the agenda and Cyprus proposed the creation of a working group on migrants. However, due to time constraints and taking considering the importance of the issue, it was agreed that proper discussion in a future meeting is necessary. It was underlined that as the summer period is approaching the situation will be aggravated due to the increasing influx of migrants. ECDC, in collaboration with the Member States, the Commission and WHO, continues to closely monitor the situation to rapidly identify and assess potential communicable disease threats. Two EPIET fellows are currently deployed in Greece and are closely working with the Greek authorities. 6

7 Cyprus was asked to send its proposal for the creation of a working group in writing. Before the summer break an audio-conference will be organised to discuss the migration issue. The next plenary meeting of the HSC is scheduled for 10 November Planned dates for the meetings in 2017 are June 2017 and 24 November Item 9 of the agenda on the state of play of the implementing acts and on the exercises to support the implementation of Decision 1082/2013/EU was not discussed due to lack of time. Information will be sent to the HSC in writing as an annex to the meeting minutes. 7