PURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\n\nOpinion of the European Data Protection\nSupervisor on the proposal for a decision of the European\nParliament and of the Council on serious cross-border threats to\nhealth
\nThe Proposal aims at replacing Decision 2119/98/EC\nsetting up a network for the epidemiological surveillance and\ncontrol of communicable diseases in the Community, which is the\ncurrent legal basis for the Early Warning and Response System\n(‘EWRS’). The latter has been the subject of a prior\ncheck Opinion of the EDPS.
\nThe EDPS welcomes the references to Regulation (EC) No\n45/2001 and Directive 95/46/EC in Article 18 of the proposal and\nthe fact that the reference to the applicable data protection\nlegislation inArticle 18 now encompasses all personal data\nprocessing under the scope of the proposal. He also welcomes the\nspecific data protection safeguards for contact tracing set forth,\nor required to be adopted by the Commission, under Article\n18.
\nHowever, the following elements of the Proposal still\nrequire, or would benefit from, clarification, further detail or\nother improvements from the point of view of data\nprotection:
\n\n· \ncontact tracing,
\n\n· \nad hoc surveillance,
\n\n· \ncontroller-processor relationship,
\n\n· \nretention period, and
\n\n· \nsecurity measures.
\nThe EDPS notes that several aspects of the proposal\nare not elaborated in the text itself, but will be the subject of\ndelegated and implementing acts, such as the list of communicable\ndiseases to which the proposal shall apply and the procedures for\nthe information exchange in the EWRS. Other aspects will be\nclarified in guidelines and recommendations to be adopted by the\nCommission, such as the data protection guidelines for the\nEWRS.
\nWhilst details can of course be regulated in delegated\nand implementing acts, and such additional provisions are certainly\nof great benefit, the EDPS recommends that the proposal itself also\nprovide more guidance on some of the points mentioned\nabove.
\nRecommendations: in\ngeneral, the EDPS recommends that some essential elements,\nincluding certain essential data protection safeguards, should be\nalso included in the text of the proposal itself. In addition, some\nclarifications are also necessary due to the expansion of the scope\nof the proposal to additional health threats beyond communicable\ndiseases, which have not been subject to the prior checking\nprocedure and also not discussed in the guidelines.
\nMore particularly, the EDPS recommends that the\nProposal should:
\nMinisters held an orientation debate on\na draft decision aimed at strengthening EU capacities and\nstructures for effectively responding to serious cross-border\nhealth threats.
\nState of play: Member states stressed the importance of\npreparedness against serious cross-border threats to health, and\nconsidered that it could be achieved through coordination and\nthe exchange of information between member states within the health\nsecurity committee (HSC), rather than an obligation for prior\nconsultations or recommendations by the Commission. This was\nregarded important in order to respect national competencies in the\nfield of health and to be in line with article 168 of the Treaty on\nthe Functioning of the EU.
\nMinisters supported the Commission proposal to\nprovide a legal mandate to the health security committee. As\nregards the composition of this committee, most ministers argued\nfor a standing committee of high representatives nominated\nby public health authorities with the possibility of inviting\nexperts on a case-by-case basis.
\nMember states confirmed their wish to delete\narticle 12 of the Commission proposal which envisages the\npossibility of binding common temporary public health measures at\nEU level. Instead they shared the view that member states\nshould deal with urgent cases of cross-border health threats\nthrough the HSC.
\nThe discussion gave guidance for future work on\nthis file that will continue during the incoming Cyprus\npresidency.
\nThe\nCommission’s point of view on the Council’s compromise\ntext: the Commission considers that:
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the report by Gilles PARGNEAUX (S&D, FR) on\nthe proposal for a decision of the European Parliament and of the\nCouncil on serious cross-border threats to health.
\nThe committee recommends that the European\nParliament’s position adopted at first reading, under the\nordinary legislative procedure, should amend the Commission\nproposal as follows:
\nSubject matter: Members\nconsider that this Decision should define the roles, duties and\nresponsibilities of the key actors and structures at Union\nlevel, as well as the methods of cooperation and coordination\nenvisaged between the various institutions.
\nThis Decision shall apply in case of threats of\nbiological origin, consisting of communicable diseases,\nincluding human zoonotic infections.
\nPreparedness and response planning: Member States shall, in liaison with the Commission\nand on the basis of its recommendations, within the Health Security\nCommittee, address the following issues: (i) the adoption of\nguidance and other awareness materials on the health and\nhygiene measures that the public must follow in the event of\nserious cross-border threats to health; (ii) the communication of\nbest practices.
\nMembers also stress that information on\ncommunicable disease monitoring and vaccination coverage as set\nout in Decision 2119/98/EC on epidemiological surveillance will be\nessential to Commission led preparedness and response\nplanning.
\nRecalling that according to the World Health\nOrganisation, more than 60% of human infections are zoonoses\noriginating in animals or animal products, the report highlights\nthat an holistic approach needs to be taken, with coordination and\nclose cooperation between the human health and veterinary\nsectors being a crucial component of this.
\nThe Health Security Committee shall advise the health ministers of the Member States\nand the Commission on the preparation and coordination of\ncontingency plans.
\nCommunication strategy:\nMembers consider that this decision should further stress the\nimportance of implementing a consistent and coordinated\ncommunication strategy should a crisis arise. They propose\nintroducing a specific article stipulating that the actors in the\nEarly Warning and Response System shall develop their communication\nstrategy in line with the case in hand in order to keep citizens\ninformed of the risk and the measures taken. That communication\nstrategy shall stipulate the content of the message and the time of\ncommunication about the problem in question, including the most\nsuitable arrangements for distribution.
\nRisk assessment and common public health\nmeasures: public health risk\nassessment should also be based on the opinion of the WHO in\nthe case of an international public health emergency. The common\ntemporary measures adopted should be consistent with the\nrecommendations established by the World Health Organisation in the\ncase of an international public health emergency. When adopting\ncommon temporary public health measures, the Commission must\nspecify the reasons for adopting these measures.
\nRecognition of emergency situations: Members state that the term ‘emergency\nsituations’ should cover everything. There is no need\nto specify pandemic influenza situations separately.
\nNational authorities and\nrepresentatives: as there are various\nMember States where responsibility for public health is not an\nexclusively national matter, but is substantially decentralised,\nMembers consider it crucial to guarantee that national\nauthorities involve the relevant decision-making authorities in\nthe implementation of this decision in the Member States. They\nstress that the public nature of the appointment of structures or\nauthorities which are part of the Community network should be\nemphasised. Measures as regards the confidentiality of\npersonal data should be strengthened.
\nPolitical dialogue:\nMembers state that regular dialogue should be established between\nthe Commission and the European Parliament so that the\nlatter may be informed of the activities and the proper functioning\nof the Early Warning and Response System.
\nIn the case of a health warning, the Commission must,\nwithin the two months following the adoption of measures, submit a\ndetailed report to the European Parliament and the Council on the\ncontent of these measures and their contribution to reducing the\nserious cross-border threat to health.
\nThe Council took stock of progress made on a\ndraft decision aimed at strengthening EU capacities and structures\nfor effectively responding to serious cross-border health threats,\nand gave the Irish Presidency a basis on which to start\nnegotiations.
\nUnder the Cypriot Presidency, good progress has been\nachieved and the draft decision has been amended in line with\nMember States' comments. The changes proposed by the Cypriot\nPresidency:
\nHowever, the Commission considers that its proposal\nhas been weakened in several\nrespects, which makes it difficult for the Commission to accept the\ndirection in which the consensus among the Member States is\nmoving.
\nThis is in particular the case as regards preparedness\nplanning and the possibility to provide a \"safety net\" via\n\"temporary public health measures\". The Commission has therefore\nreserved its position on related articles.
\nA few issues still remain open and further discussions are needed in order to reach\nagreement in the Council ahead of possible negotiations with the\nEuropean Parliament with a view to a first reading agreement.\nThe main changes introduced during the Cypriot Presidency,\nalso focusing on the open questions, are described\nbelow:
\nScope: it has been\nclarified that it does not include threats from ionizing radiation\nas these are sufficiently covered by the Treaty establishing the\nEuropean Atomic Energy Community. In the event of exceptional\nemergencies, the structures to be established by the draft Decision\nshould also be available to the Member States and the Commission\nfor threats that are not covered by the scope of this draft\nDecision.
\nPreparedness and response planning: the question of empowering the Commission to adopt\nimplementing acts to determine the procedures necessary for the\nexchange of information and mutual consultation among Member States\nin accordance with Article 4 has been extensively debated. The\nPresidency is now proposing to delete Article 4(5) and to instruct\nthe HSC in Article 17(5) (e) to adopt those procedures. This is\nsupported by a majority of the Member States, while some Member\nStates are opposed to this proposal.
\nJoint procurement of medical\ncountermeasures: the introduction of\na voluntary system for joint procurement of medical\ncountermeasures, especially pandemic vaccines, should contribute to\nfairer access to them for the Member States participating.\nNevertheless, a few Member States cannot agree to this article and\nare calling for the Commission to propose a separate\ndecision.
\nEpidemiological surveillance: in line with the judgment of the Court of Justice of\nthe EU, the criteria for the selection of communicable diseases and\nspecial health issues to be covered by the Community Network as\ncurrently set out in Annex II to Commission Decision 2000/96/EC\nhave been stipulated in the Annex to the draft decision.
\nAd hocmonitoring: the\nCommission's proposal to set up an ad hoc monitoring network\nby means of implementing acts for health threats other than\ncommunicable diseases and special health issues permanently\nmonitored by the Union's Early Warning and Response System (e.g.\nthreats of chemical, environmental or unknown origin), has not\nreceived support.
\nPublic health risk assessment: according to the current version of the article, the\nCommission shall, upon request of the Health Security Committee, or\non its own initiative, ask the Member States to propose through\nsingle contact points independent experts for an ad hoc\nnomination by the Commission to establish risk assessment where\nexpertise beyond the mandate of the EU agencies is\nneeded.
\nCoordination of response: this article, which was largely agreed on during the\nDanish Presidency, was subject to an addition stipulating that\nMember States shall not be obliged to submit information the\ndisclosure of which they consider contrary to essential interests\nof their security.
\nRecognition of emergency situations: the text now states that a recognition of emergency,\napplicable only to the EU, can be made by the Commission if the WHO\nhas not yet reacted, the cross-border health threat is rapidly\nspreading across the Union and can be prevented by medicinal\nproducts.
\nConclusion of international agreements: a recital has been added to clarify that conclusion\nof international cooperation agreements may be in the interest of\nthe Union in order to foster the exchange of relevant information\nfrom monitoring and alerting systems on serious cross-border\nthreats to health.
\nEstablishment of the Health Security Committee\n(HSC): the composition of the HSC has\nbeen the subject of repeated discussions. It has finally been\nagreed that the HSC should be composed of one designated\nrepresentative of each Member State and one alternate, who should\nmeet in plenary meetings. Membership of the HSC will therefore be\nnominative and will not generally be ensured by authorities of\nMember States.
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the report by Gilles PARGNEAUX (S&D, FR) on\nthe proposal for a decision of the European Parliament and of the\nCouncil on serious cross-border threats to health.
\nThe committee recommends that the European\nParliament’s position adopted at first reading, under the\nordinary legislative procedure, should amend the Commission\nproposal as follows:
\nSubject matter: Members\nconsider that this Decision should define the roles, duties and\nresponsibilities of the key actors and structures at Union\nlevel, as well as the methods of cooperation and coordination\nenvisaged between the various institutions.
\nThis Decision shall apply in case of threats of\nbiological origin, consisting of communicable diseases,\nincluding human zoonotic infections.
\nPreparedness and response planning: Member States shall, in liaison with the Commission\nand on the basis of its recommendations, within the Health Security\nCommittee, address the following issues: (i) the adoption of\nguidance and other awareness materials on the health and\nhygiene measures that the public must follow in the event of\nserious cross-border threats to health; (ii) the communication of\nbest practices.
\nMembers also stress that information on\ncommunicable disease monitoring and vaccination coverage as set\nout in Decision 2119/98/EC on epidemiological surveillance will be\nessential to Commission led preparedness and response\nplanning.
\nRecalling that according to the World Health\nOrganisation, more than 60% of human infections are zoonoses\noriginating in animals or animal products, the report highlights\nthat an holistic approach needs to be taken, with coordination and\nclose cooperation between the human health and veterinary\nsectors being a crucial component of this.
\nThe Health Security Committee shall advise the health ministers of the Member States\nand the Commission on the preparation and coordination of\ncontingency plans.
\nCommunication strategy:\nMembers consider that this decision should further stress the\nimportance of implementing a consistent and coordinated\ncommunication strategy should a crisis arise. They propose\nintroducing a specific article stipulating that the actors in the\nEarly Warning and Response System shall develop their communication\nstrategy in line with the case in hand in order to keep citizens\ninformed of the risk and the measures taken. That communication\nstrategy shall stipulate the content of the message and the time of\ncommunication about the problem in question, including the most\nsuitable arrangements for distribution.
\nRisk assessment and common public health\nmeasures: public health risk\nassessment should also be based on the opinion of the WHO in\nthe case of an international public health emergency. The common\ntemporary measures adopted should be consistent with the\nrecommendations established by the World Health Organisation in the\ncase of an international public health emergency. When adopting\ncommon temporary public health measures, the Commission must\nspecify the reasons for adopting these measures.
\nRecognition of emergency situations: Members state that the term ‘emergency\nsituations’ should cover everything. There is no need\nto specify pandemic influenza situations separately.
\nNational authorities and\nrepresentatives: as there are various\nMember States where responsibility for public health is not an\nexclusively national matter, but is substantially decentralised,\nMembers consider it crucial to guarantee that national\nauthorities involve the relevant decision-making authorities in\nthe implementation of this decision in the Member States. They\nstress that the public nature of the appointment of structures or\nauthorities which are part of the Community network should be\nemphasised. Measures as regards the confidentiality of\npersonal data should be strengthened.
\nPolitical dialogue:\nMembers state that regular dialogue should be established between\nthe Commission and the European Parliament so that the\nlatter may be informed of the activities and the proper functioning\nof the Early Warning and Response System.
\nIn the case of a health warning, the Commission must,\nwithin the two months following the adoption of measures, submit a\ndetailed report to the European Parliament and the Council on the\ncontent of these measures and their contribution to reducing the\nserious cross-border threat to health.
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nLes ministres ont\ntenu un débat d'orientation sur le projet de\ndécision visant à renforcer les capacités et\nles structures de l'UE pour réagir efficacement aux menaces\ntransfrontières graves pour la santé. La\nPrésidence a notamment axé sa réflexion sur un\ndocument\nd’ensemble qui devait être débattu lors du\nConseil du 21 juin 2012.
\nÉtat des\nlieux des travaux : les États membres ont\nsouligné l'importance que revêt la préparation\nà l'égard des menaces transfrontières graves\npour la santé et estiment que cette préparation\npourrait être assurée par la coordination et\nl'échange d'informations entre États membres dans le\ncadre du Comité de sécurité sanitaire\n(CSS), plutôt que par une obligation de consultations\npréalables ou des recommandations de la Commission. Cela a\nété jugé important pour assurer le respect des\ncompétences nationales dans le domaine de la santé\nainsi que la conformité à l'article 168 du\ntraité sur le fonctionnement de l'UE.
\nLes ministres ont\nsoutenu la proposition de la Commission visant à\nconférer au Comité de sécurité\nsanitaire (CSS) un mandat juridique. S'agissant de la\ncomposition de ce premier comité, la plupart des ministres\nont plaidé en faveur d'un comité permanent de\nhauts représentants nommés par les\nautorités sanitaires publiques avec la possibilité\nd'inviter des experts au cas par cas.
\nLes États\nmembres ont confirmé leur souhait de supprimer l'article\n12 de la proposition de la Commission, qui prévoit la\npossibilité d'adopter au niveau de l'UE des mesures communes\net temporaires de santé publique qui soient\ncontraignantes. Ils ont été d'accord pour\nestimer, au contraire, que les États membres devraient\nréagir aux cas urgents de menaces transfrontières\ngraves via le CSS.
\nLes discussions ont\npermis de dégager des orientations pour les travaux futurs\nsur ce dossier, qui se poursuivront sous la présidence\nchypriote.
\nPoint de vue de\nla Commission sur le compromis du Conseil : pour sa part,\nla Commission s’est exprimée sur l’état de\nce dossier au Conseil et a mis en lumière sont point de\nvue:
\nOBJECTIF :\nétablir une initiative européenne destinée\nà lutter contre les menaces transfrontières graves\npour la santé.
\nACTE PROPOSÉ\n: Décision du Parlement européen et du Conseil.
\nCONTEXTE : de\nnombreuses activités liées à la planification\nde la préparation et de l’intervention et à\nl’évaluation des risques relative aux maladies\ntransmissibles, mais aussi aux menaces pour la santé\nd’origine chimique et aux événements\ncausés par le changement climatique, ont été\nsoutenues au plan européen, notamment via l’actuel\nréseau de surveillance épidémiologique et de\ncontrôle des maladies transmissibles (voir Décision\n2119/98/CE du Parlement et du Conseil instaurant un\nréseau de surveillance épidémiologique et de\ncontrôle des maladies transmissibles dans la\nCommunauté). L’UE dispose notamment de politiques, de\nmécanismes et d’instruments permettant la\nprévention et le contrôle des menaces\ntransfrontières graves et le développement de\ncapacités de gestion des crises (mécanisme de\nprotection civile de l’UE, Fonds de cohésion et de\nsolidarité, plan d’action de l’UE en\nmatière de sécurité chimique, biologique,\nradiologique et nucléaire et réseaux d’alerte\neuropéens comme Ecurie).
\nAfin\nd’éviter les chevauchements avec ces domaines et la\nduplication des structures actuelles de prévention et de\ncontrôle des catastrophes, il a été\nprocédé à une analyse des écarts afin\nde déterminer dans quelle mesure les systèmes\nexistants assuraient la surveillance et la notification des menaces\npour la santé et l’évaluation des risques y\nafférents, et pour vérifier leurs capacités et\nstructures de gestion des crises touchant à la santé\npublique. Cette analyse a révélé que les\nstructures et mécanismes actuels au niveau de l’UE ne\ntraitent pas ces menaces assez efficacement sur le plan de la\nsanté publique.
\nCette lacune est\nsource de disparités dans la manière\nd’apprécier le danger que représente une menace\ndonnée, débouche sur la redondance des\névaluations menées dans les différents\nÉtats membres et conduit à l’adoption de mesures\nincohérentes à l’échelle de l’Union.\nCette situation peut aussi entraîner l’utilisation\ninefficace des ressources limitées actuellement\ndisponibles.
\nBien\nqu’il incombe aux États membres de gérer les\ncrises de santé publique à l’échelon\nnational, aucun pays ne peut à lui seul combattre une crise\ninternationale en matière de santé publique. Au\nniveau de l’UE, les dispositions juridiques régissant\nla lutte contre les menaces transfrontières graves pour la\nsanté ont été renforcées par le\ntraité de Lisbonne. L’UE peut désormais adopter\ndes mesures dans ce domaine, pour compléter et appuyer les\npolitiques nationales et encourager la coopération entre les\nÉtats membres.
\nC’est la\nraison pour laquelle, il est proposé de créer un\nnouvel instrument destiné à intensifier la\ncoopération et à renforcer la coordination dans le\ndomaine de la notification et de l’évaluation des\nrisques. L’objectif est de rationaliser et renforcer les\ncapacités et les structures de l’Union\neuropéenne afin de répondre efficacement aux\nmenaces transfrontières graves pour la santé, quelle\nqu’en soit la nature : menaces liées à des\névénements causés par des maladies\ntransmissibles ou des agents biologiques, menaces d’origine\nchimique ou environnementale ou encore menaces dues aux effets du\nchangement climatique.
\nANALYSE\nD’IMPACT : la Commission a procédé à\nl’analyse détaillée de 3 options:
\nLes\nrésultats de l’analyse ont abouti à la\nconclusion que l’option 3 avait les effets les plus\npositifs en matière de santé, car elle\ncontribuait à améliorer la protection des citoyens\ncontre les menaces transfrontières graves pour la\nsanté.
\nBASE JURIDIQUE :\narticle 168, par. 4, point c), et par. 5 du traité sur le\nfonctionnement de l’Union européenne (TFUE).
\nCONTENU : la\nprésente proposition établit les règles\nrelatives à la surveillance des menaces\ntransfrontières graves pour la santé, à\nl’alerte en cas de telles menaces et à la lutte contre\ncelles-ci, ainsi que celles relatives à la planification de\nla préparation et de l’intervention liées\nà ces activités. Elle vise à favoriser la\nprévention de maladies humaines graves et la lutte contre\nleur propagation transfrontière dans les États\nmembres, et à prévenir d’autres sources majeures\nde menace transfrontière grave pour la santé afin de\ncontribuer à un niveau élevé de protection de\nla santé publique dans l’Union.
\nChamp\nd’application : la proposition s’applique dans\nles cas de menaces transfrontières graves pour la\nsanté relevant des catégories suivantes:
\nStructure\ngénérale : le système de surveillance\ns’articule autour des 4 grands domaines suivants :
\n\n1) dans\nle domaine de la planification de la préparation, la\nproposition prévoit la coordination des efforts des\nÉtats membres en ce qui concerne l’amélioration\nde la préparation et le renforcement des capacités.\nÀ cette fin, la Commission assurera la coordination entre\nles systèmes de planification nationaux et entre les\nsecteurs clés, tels que le transport, l’énergie\net la protection civile. Dans le cadre de cette planification, il\nest prévu d’instituer une procédure conjointe\nde passation de marché relative à des\ncontre-mesures médicales au niveau de l’UE, auquel les\nparties contractantes pourraient participer à titre\nvolontaire pour acheter des contre-mesures médicales, par\nexemple des vaccins contre la grippe pandémique, ce qui\npermettrait à l’UE d’être mieux\npréparée aux futures pandémies ;
\n\n2) la\nmise en place d’un réseau de surveillance\népidémiologique afin de fournir les informations et\ndonnées nécessaires à l’évaluation\ndes risques : ce réseau ad hoc serait mis en\nplace lorsqu’un État membre signalera une menace grave\nautre qu’une maladie transmissible. Les maladies\ntransmissibles continueront à être surveillées\ncomme actuellement ;
\n\n3) \nl’utilisation du système actuel d’alerte\nprécoce et de réaction pour qu’il couvre\ntoutes les menaces graves pour la santé, et pas uniquement\nles maladies transmissibles comme c’est le cas\naujourd’hui ;
\n\n4) la\nréalisation coordonnée d’évaluations\nnationales ou européennes des risques que\nprésentent pour la santé les menaces d’origine\nbiologique, chimique, environnementale ou inconnue en situation de\ncrise.
\nRéaction\nsanitaire européenne : la proposition\nétablit en outre un cadre cohérent régissant\nla réaction de l’UE en cas de crise de santé\npublique. Concrètement, en officialisant le\ncomité de sécurité sanitaire existant,\nl’UE sera mieux à même de coordonner les\nréactions nationales en cas d’urgence de santé\npublique. Une procédure de mobilisation et de coordination\nde la réaction européenne face à une menace\nsanitaire grave est ainsi proposée. Ainsi, si un État\nmembre a l’intention d’adopter des mesures de\nsanté publique pour lutter contre une menace\ntransfrontière grave pour la santé, il doit, avant\nd’adopter ces mesures, consulter les autres États\nmembres et la Commission au sujet de la nature, de l’objet et\ndu champ d’application des mesures. Les mesures prises sont\nalors décidées, par voie d’actes\nd’exécution.
\nSont\négalement prévues les mesures spécifiques\nsuivantes :
\nINCIDENCE\nBUDGÉTAIRE : la proposition n’a pas d’incidence\nsur les agences décentralisées. Le programme actuel\nde l’UE en matière de santé comprend\ndéjà des activités liées à la\nsurveillance, à l’alerte et à\nl’évaluation des risques en ce qui concerne certaines\nmenaces pour la santé. Après 2013, la Commission a\nl’intention d’inclure ces activités dans le\nprogramme «Santé en faveur de la croissance»\nproposé pour la période 2014-2020. Les coûts\ncorrespondants seront compris dans l’enveloppe proposée\npour le nouveau programme.
\nACTES\nDÉLÉGUÉS : le pouvoir d’adopter des\nactes délégués conformément à\nl’article 290 du TFUE devrait être conféré\nà la Commission en ce qui concerne les mesures\nnécessaires pour compléter l’action des\nÉtats membres, dans des situations d’urgence\ntrès spécifiques, à l’égard\ndes aspects transnationaux de la lutte contre les menaces\ntransfrontières graves pour la santé. Afin de\ngarantir des conditions uniformes d’exécution de la\nprésente proposition, les compétences\nd’exécution seraient conférées à\nla Commission en vue de l’adoption d’actes\nd’exécution en ce qui concerne:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\n\nOpinion of the European Data Protection\nSupervisor on the proposal for a decision of the European\nParliament and of the Council on serious cross-border threats to\nhealth
\nThe Proposal aims at replacing Decision 2119/98/EC\nsetting up a network for the epidemiological surveillance and\ncontrol of communicable diseases in the Community, which is the\ncurrent legal basis for the Early Warning and Response System\n(‘EWRS’). The latter has been the subject of a prior\ncheck Opinion of the EDPS.
\nThe EDPS welcomes the references to Regulation (EC) No\n45/2001 and Directive 95/46/EC in Article 18 of the proposal and\nthe fact that the reference to the applicable data protection\nlegislation inArticle 18 now encompasses all personal data\nprocessing under the scope of the proposal. He also welcomes the\nspecific data protection safeguards for contact tracing set forth,\nor required to be adopted by the Commission, under Article\n18.
\nHowever, the following elements of the Proposal still\nrequire, or would benefit from, clarification, further detail or\nother improvements from the point of view of data\nprotection:
\n\n· \ncontact tracing,
\n\n· \nad hoc surveillance,
\n\n· \ncontroller-processor relationship,
\n\n· \nretention period, and
\n\n· \nsecurity measures.
\nThe EDPS notes that several aspects of the proposal\nare not elaborated in the text itself, but will be the subject of\ndelegated and implementing acts, such as the list of communicable\ndiseases to which the proposal shall apply and the procedures for\nthe information exchange in the EWRS. Other aspects will be\nclarified in guidelines and recommendations to be adopted by the\nCommission, such as the data protection guidelines for the\nEWRS.
\nWhilst details can of course be regulated in delegated\nand implementing acts, and such additional provisions are certainly\nof great benefit, the EDPS recommends that the proposal itself also\nprovide more guidance on some of the points mentioned\nabove.
\nRecommendations: in\ngeneral, the EDPS recommends that some essential elements,\nincluding certain essential data protection safeguards, should be\nalso included in the text of the proposal itself. In addition, some\nclarifications are also necessary due to the expansion of the scope\nof the proposal to additional health threats beyond communicable\ndiseases, which have not been subject to the prior checking\nprocedure and also not discussed in the guidelines.
\nMore particularly, the EDPS recommends that the\nProposal should:
\nMinisters held an orientation debate on\na draft decision aimed at strengthening EU capacities and\nstructures for effectively responding to serious cross-border\nhealth threats.
\nState of play: Member states stressed the importance of\npreparedness against serious cross-border threats to health, and\nconsidered that it could be achieved through coordination and\nthe exchange of information between member states within the health\nsecurity committee (HSC), rather than an obligation for prior\nconsultations or recommendations by the Commission. This was\nregarded important in order to respect national competencies in the\nfield of health and to be in line with article 168 of the Treaty on\nthe Functioning of the EU.
\nMinisters supported the Commission proposal to\nprovide a legal mandate to the health security committee. As\nregards the composition of this committee, most ministers argued\nfor a standing committee of high representatives nominated\nby public health authorities with the possibility of inviting\nexperts on a case-by-case basis.
\nMember states confirmed their wish to delete\narticle 12 of the Commission proposal which envisages the\npossibility of binding common temporary public health measures at\nEU level. Instead they shared the view that member states\nshould deal with urgent cases of cross-border health threats\nthrough the HSC.
\nThe discussion gave guidance for future work on\nthis file that will continue during the incoming Cyprus\npresidency.
\nThe\nCommission’s point of view on the Council’s compromise\ntext: the Commission considers that:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nMinisters held an orientation debate on\na draft decision aimed at strengthening EU capacities and\nstructures for effectively responding to serious cross-border\nhealth threats.
\nState of play: Member states stressed the importance of\npreparedness against serious cross-border threats to health, and\nconsidered that it could be achieved through coordination and\nthe exchange of information between member states within the health\nsecurity committee (HSC), rather than an obligation for prior\nconsultations or recommendations by the Commission. This was\nregarded important in order to respect national competencies in the\nfield of health and to be in line with article 168 of the Treaty on\nthe Functioning of the EU.
\nMinisters supported the Commission proposal to\nprovide a legal mandate to the health security committee. As\nregards the composition of this committee, most ministers argued\nfor a standing committee of high representatives nominated\nby public health authorities with the possibility of inviting\nexperts on a case-by-case basis.
\nMember states confirmed their wish to delete\narticle 12 of the Commission proposal which envisages the\npossibility of binding common temporary public health measures at\nEU level. Instead they shared the view that member states\nshould deal with urgent cases of cross-border health threats\nthrough the HSC.
\nThe discussion gave guidance for future work on\nthis file that will continue during the incoming Cyprus\npresidency.
\nThe\nCommission’s point of view on the Council’s compromise\ntext: the Commission considers that:
\n\nOpinion of the European Data Protection\nSupervisor on the proposal for a decision of the European\nParliament and of the Council on serious cross-border threats to\nhealth
\nThe Proposal aims at replacing Decision 2119/98/EC\nsetting up a network for the epidemiological surveillance and\ncontrol of communicable diseases in the Community, which is the\ncurrent legal basis for the Early Warning and Response System\n(‘EWRS’). The latter has been the subject of a prior\ncheck Opinion of the EDPS.
\nThe EDPS welcomes the references to Regulation (EC) No\n45/2001 and Directive 95/46/EC in Article 18 of the proposal and\nthe fact that the reference to the applicable data protection\nlegislation inArticle 18 now encompasses all personal data\nprocessing under the scope of the proposal. He also welcomes the\nspecific data protection safeguards for contact tracing set forth,\nor required to be adopted by the Commission, under Article\n18.
\nHowever, the following elements of the Proposal still\nrequire, or would benefit from, clarification, further detail or\nother improvements from the point of view of data\nprotection:
\n\n· \ncontact tracing,
\n\n· \nad hoc surveillance,
\n\n· \ncontroller-processor relationship,
\n\n· \nretention period, and
\n\n· \nsecurity measures.
\nThe EDPS notes that several aspects of the proposal\nare not elaborated in the text itself, but will be the subject of\ndelegated and implementing acts, such as the list of communicable\ndiseases to which the proposal shall apply and the procedures for\nthe information exchange in the EWRS. Other aspects will be\nclarified in guidelines and recommendations to be adopted by the\nCommission, such as the data protection guidelines for the\nEWRS.
\nWhilst details can of course be regulated in delegated\nand implementing acts, and such additional provisions are certainly\nof great benefit, the EDPS recommends that the proposal itself also\nprovide more guidance on some of the points mentioned\nabove.
\nRecommendations: in\ngeneral, the EDPS recommends that some essential elements,\nincluding certain essential data protection safeguards, should be\nalso included in the text of the proposal itself. In addition, some\nclarifications are also necessary due to the expansion of the scope\nof the proposal to additional health threats beyond communicable\ndiseases, which have not been subject to the prior checking\nprocedure and also not discussed in the guidelines.
\nMore particularly, the EDPS recommends that the\nProposal should:
\nThe Council took stock of progress made on a\ndraft decision aimed at strengthening EU capacities and structures\nfor effectively responding to serious cross-border health threats,\nand gave the Irish Presidency a basis on which to start\nnegotiations.
\nUnder the Cypriot Presidency, good progress has been\nachieved and the draft decision has been amended in line with\nMember States' comments. The changes proposed by the Cypriot\nPresidency:
\nHowever, the Commission considers that its proposal\nhas been weakened in several\nrespects, which makes it difficult for the Commission to accept the\ndirection in which the consensus among the Member States is\nmoving.
\nThis is in particular the case as regards preparedness\nplanning and the possibility to provide a \"safety net\" via\n\"temporary public health measures\". The Commission has therefore\nreserved its position on related articles.
\nA few issues still remain open and further discussions are needed in order to reach\nagreement in the Council ahead of possible negotiations with the\nEuropean Parliament with a view to a first reading agreement.\nThe main changes introduced during the Cypriot Presidency,\nalso focusing on the open questions, are described\nbelow:
\nScope: it has been\nclarified that it does not include threats from ionizing radiation\nas these are sufficiently covered by the Treaty establishing the\nEuropean Atomic Energy Community. In the event of exceptional\nemergencies, the structures to be established by the draft Decision\nshould also be available to the Member States and the Commission\nfor threats that are not covered by the scope of this draft\nDecision.
\nPreparedness and response planning: the question of empowering the Commission to adopt\nimplementing acts to determine the procedures necessary for the\nexchange of information and mutual consultation among Member States\nin accordance with Article 4 has been extensively debated. The\nPresidency is now proposing to delete Article 4(5) and to instruct\nthe HSC in Article 17(5) (e) to adopt those procedures. This is\nsupported by a majority of the Member States, while some Member\nStates are opposed to this proposal.
\nJoint procurement of medical\ncountermeasures: the introduction of\na voluntary system for joint procurement of medical\ncountermeasures, especially pandemic vaccines, should contribute to\nfairer access to them for the Member States participating.\nNevertheless, a few Member States cannot agree to this article and\nare calling for the Commission to propose a separate\ndecision.
\nEpidemiological surveillance: in line with the judgment of the Court of Justice of\nthe EU, the criteria for the selection of communicable diseases and\nspecial health issues to be covered by the Community Network as\ncurrently set out in Annex II to Commission Decision 2000/96/EC\nhave been stipulated in the Annex to the draft decision.
\nAd hocmonitoring: the\nCommission's proposal to set up an ad hoc monitoring network\nby means of implementing acts for health threats other than\ncommunicable diseases and special health issues permanently\nmonitored by the Union's Early Warning and Response System (e.g.\nthreats of chemical, environmental or unknown origin), has not\nreceived support.
\nPublic health risk assessment: according to the current version of the article, the\nCommission shall, upon request of the Health Security Committee, or\non its own initiative, ask the Member States to propose through\nsingle contact points independent experts for an ad hoc\nnomination by the Commission to establish risk assessment where\nexpertise beyond the mandate of the EU agencies is\nneeded.
\nCoordination of response: this article, which was largely agreed on during the\nDanish Presidency, was subject to an addition stipulating that\nMember States shall not be obliged to submit information the\ndisclosure of which they consider contrary to essential interests\nof their security.
\nRecognition of emergency situations: the text now states that a recognition of emergency,\napplicable only to the EU, can be made by the Commission if the WHO\nhas not yet reacted, the cross-border health threat is rapidly\nspreading across the Union and can be prevented by medicinal\nproducts.
\nConclusion of international agreements: a recital has been added to clarify that conclusion\nof international cooperation agreements may be in the interest of\nthe Union in order to foster the exchange of relevant information\nfrom monitoring and alerting systems on serious cross-border\nthreats to health.
\nEstablishment of the Health Security Committee\n(HSC): the composition of the HSC has\nbeen the subject of repeated discussions. It has finally been\nagreed that the HSC should be composed of one designated\nrepresentative of each Member State and one alternate, who should\nmeet in plenary meetings. Membership of the HSC will therefore be\nnominative and will not generally be ensured by authorities of\nMember States.
\n\nOpinion of the European Data Protection\nSupervisor on the proposal for a decision of the European\nParliament and of the Council on serious cross-border threats to\nhealth
\nThe Proposal aims at replacing Decision 2119/98/EC\nsetting up a network for the epidemiological surveillance and\ncontrol of communicable diseases in the Community, which is the\ncurrent legal basis for the Early Warning and Response System\n(‘EWRS’). The latter has been the subject of a prior\ncheck Opinion of the EDPS.
\nThe EDPS welcomes the references to Regulation (EC) No\n45/2001 and Directive 95/46/EC in Article 18 of the proposal and\nthe fact that the reference to the applicable data protection\nlegislation inArticle 18 now encompasses all personal data\nprocessing under the scope of the proposal. He also welcomes the\nspecific data protection safeguards for contact tracing set forth,\nor required to be adopted by the Commission, under Article\n18.
\nHowever, the following elements of the Proposal still\nrequire, or would benefit from, clarification, further detail or\nother improvements from the point of view of data\nprotection:
\n\n· \ncontact tracing,
\n\n· \nad hoc surveillance,
\n\n· \ncontroller-processor relationship,
\n\n· \nretention period, and
\n\n· \nsecurity measures.
\nThe EDPS notes that several aspects of the proposal\nare not elaborated in the text itself, but will be the subject of\ndelegated and implementing acts, such as the list of communicable\ndiseases to which the proposal shall apply and the procedures for\nthe information exchange in the EWRS. Other aspects will be\nclarified in guidelines and recommendations to be adopted by the\nCommission, such as the data protection guidelines for the\nEWRS.
\nWhilst details can of course be regulated in delegated\nand implementing acts, and such additional provisions are certainly\nof great benefit, the EDPS recommends that the proposal itself also\nprovide more guidance on some of the points mentioned\nabove.
\nRecommendations: in\ngeneral, the EDPS recommends that some essential elements,\nincluding certain essential data protection safeguards, should be\nalso included in the text of the proposal itself. In addition, some\nclarifications are also necessary due to the expansion of the scope\nof the proposal to additional health threats beyond communicable\ndiseases, which have not been subject to the prior checking\nprocedure and also not discussed in the guidelines.
\nMore particularly, the EDPS recommends that the\nProposal should:
\n\nOpinion of the European Data Protection\nSupervisor on the proposal for a decision of the European\nParliament and of the Council on serious cross-border threats to\nhealth
\nThe Proposal aims at replacing Decision 2119/98/EC\nsetting up a network for the epidemiological surveillance and\ncontrol of communicable diseases in the Community, which is the\ncurrent legal basis for the Early Warning and Response System\n(‘EWRS’). The latter has been the subject of a prior\ncheck Opinion of the EDPS.
\nThe EDPS welcomes the references to Regulation (EC) No\n45/2001 and Directive 95/46/EC in Article 18 of the proposal and\nthe fact that the reference to the applicable data protection\nlegislation inArticle 18 now encompasses all personal data\nprocessing under the scope of the proposal. He also welcomes the\nspecific data protection safeguards for contact tracing set forth,\nor required to be adopted by the Commission, under Article\n18.
\nHowever, the following elements of the Proposal still\nrequire, or would benefit from, clarification, further detail or\nother improvements from the point of view of data\nprotection:
\n\n· \ncontact tracing,
\n\n· \nad hoc surveillance,
\n\n· \ncontroller-processor relationship,
\n\n· \nretention period, and
\n\n· \nsecurity measures.
\nThe EDPS notes that several aspects of the proposal\nare not elaborated in the text itself, but will be the subject of\ndelegated and implementing acts, such as the list of communicable\ndiseases to which the proposal shall apply and the procedures for\nthe information exchange in the EWRS. Other aspects will be\nclarified in guidelines and recommendations to be adopted by the\nCommission, such as the data protection guidelines for the\nEWRS.
\nWhilst details can of course be regulated in delegated\nand implementing acts, and such additional provisions are certainly\nof great benefit, the EDPS recommends that the proposal itself also\nprovide more guidance on some of the points mentioned\nabove.
\nRecommendations: in\ngeneral, the EDPS recommends that some essential elements,\nincluding certain essential data protection safeguards, should be\nalso included in the text of the proposal itself. In addition, some\nclarifications are also necessary due to the expansion of the scope\nof the proposal to additional health threats beyond communicable\ndiseases, which have not been subject to the prior checking\nprocedure and also not discussed in the guidelines.
\nMore particularly, the EDPS recommends that the\nProposal should:
\nMinisters held an orientation debate on\na draft decision aimed at strengthening EU capacities and\nstructures for effectively responding to serious cross-border\nhealth threats.
\nState of play: Member states stressed the importance of\npreparedness against serious cross-border threats to health, and\nconsidered that it could be achieved through coordination and\nthe exchange of information between member states within the health\nsecurity committee (HSC), rather than an obligation for prior\nconsultations or recommendations by the Commission. This was\nregarded important in order to respect national competencies in the\nfield of health and to be in line with article 168 of the Treaty on\nthe Functioning of the EU.
\nMinisters supported the Commission proposal to\nprovide a legal mandate to the health security committee. As\nregards the composition of this committee, most ministers argued\nfor a standing committee of high representatives nominated\nby public health authorities with the possibility of inviting\nexperts on a case-by-case basis.
\nMember states confirmed their wish to delete\narticle 12 of the Commission proposal which envisages the\npossibility of binding common temporary public health measures at\nEU level. Instead they shared the view that member states\nshould deal with urgent cases of cross-border health threats\nthrough the HSC.
\nThe discussion gave guidance for future work on\nthis file that will continue during the incoming Cyprus\npresidency.
\nThe\nCommission’s point of view on the Council’s compromise\ntext: the Commission considers that:
\nMinisters held an orientation debate on\na draft decision aimed at strengthening EU capacities and\nstructures for effectively responding to serious cross-border\nhealth threats.
\nState of play: Member states stressed the importance of\npreparedness against serious cross-border threats to health, and\nconsidered that it could be achieved through coordination and\nthe exchange of information between member states within the health\nsecurity committee (HSC), rather than an obligation for prior\nconsultations or recommendations by the Commission. This was\nregarded important in order to respect national competencies in the\nfield of health and to be in line with article 168 of the Treaty on\nthe Functioning of the EU.
\nMinisters supported the Commission proposal to\nprovide a legal mandate to the health security committee. As\nregards the composition of this committee, most ministers argued\nfor a standing committee of high representatives nominated\nby public health authorities with the possibility of inviting\nexperts on a case-by-case basis.
\nMember states confirmed their wish to delete\narticle 12 of the Commission proposal which envisages the\npossibility of binding common temporary public health measures at\nEU level. Instead they shared the view that member states\nshould deal with urgent cases of cross-border health threats\nthrough the HSC.
\nThe discussion gave guidance for future work on\nthis file that will continue during the incoming Cyprus\npresidency.
\nThe\nCommission’s point of view on the Council’s compromise\ntext: the Commission considers that:
\nThe Council took stock of progress made on a\ndraft decision aimed at strengthening EU capacities and structures\nfor effectively responding to serious cross-border health threats,\nand gave the Irish Presidency a basis on which to start\nnegotiations.
\nUnder the Cypriot Presidency, good progress has been\nachieved and the draft decision has been amended in line with\nMember States' comments. The changes proposed by the Cypriot\nPresidency:
\nHowever, the Commission considers that its proposal\nhas been weakened in several\nrespects, which makes it difficult for the Commission to accept the\ndirection in which the consensus among the Member States is\nmoving.
\nThis is in particular the case as regards preparedness\nplanning and the possibility to provide a \"safety net\" via\n\"temporary public health measures\". The Commission has therefore\nreserved its position on related articles.
\nA few issues still remain open and further discussions are needed in order to reach\nagreement in the Council ahead of possible negotiations with the\nEuropean Parliament with a view to a first reading agreement.\nThe main changes introduced during the Cypriot Presidency,\nalso focusing on the open questions, are described\nbelow:
\nScope: it has been\nclarified that it does not include threats from ionizing radiation\nas these are sufficiently covered by the Treaty establishing the\nEuropean Atomic Energy Community. In the event of exceptional\nemergencies, the structures to be established by the draft Decision\nshould also be available to the Member States and the Commission\nfor threats that are not covered by the scope of this draft\nDecision.
\nPreparedness and response planning: the question of empowering the Commission to adopt\nimplementing acts to determine the procedures necessary for the\nexchange of information and mutual consultation among Member States\nin accordance with Article 4 has been extensively debated. The\nPresidency is now proposing to delete Article 4(5) and to instruct\nthe HSC in Article 17(5) (e) to adopt those procedures. This is\nsupported by a majority of the Member States, while some Member\nStates are opposed to this proposal.
\nJoint procurement of medical\ncountermeasures: the introduction of\na voluntary system for joint procurement of medical\ncountermeasures, especially pandemic vaccines, should contribute to\nfairer access to them for the Member States participating.\nNevertheless, a few Member States cannot agree to this article and\nare calling for the Commission to propose a separate\ndecision.
\nEpidemiological surveillance: in line with the judgment of the Court of Justice of\nthe EU, the criteria for the selection of communicable diseases and\nspecial health issues to be covered by the Community Network as\ncurrently set out in Annex II to Commission Decision 2000/96/EC\nhave been stipulated in the Annex to the draft decision.
\nAd hocmonitoring: the\nCommission's proposal to set up an ad hoc monitoring network\nby means of implementing acts for health threats other than\ncommunicable diseases and special health issues permanently\nmonitored by the Union's Early Warning and Response System (e.g.\nthreats of chemical, environmental or unknown origin), has not\nreceived support.
\nPublic health risk assessment: according to the current version of the article, the\nCommission shall, upon request of the Health Security Committee, or\non its own initiative, ask the Member States to propose through\nsingle contact points independent experts for an ad hoc\nnomination by the Commission to establish risk assessment where\nexpertise beyond the mandate of the EU agencies is\nneeded.
\nCoordination of response: this article, which was largely agreed on during the\nDanish Presidency, was subject to an addition stipulating that\nMember States shall not be obliged to submit information the\ndisclosure of which they consider contrary to essential interests\nof their security.
\nRecognition of emergency situations: the text now states that a recognition of emergency,\napplicable only to the EU, can be made by the Commission if the WHO\nhas not yet reacted, the cross-border health threat is rapidly\nspreading across the Union and can be prevented by medicinal\nproducts.
\nConclusion of international agreements: a recital has been added to clarify that conclusion\nof international cooperation agreements may be in the interest of\nthe Union in order to foster the exchange of relevant information\nfrom monitoring and alerting systems on serious cross-border\nthreats to health.
\nEstablishment of the Health Security Committee\n(HSC): the composition of the HSC has\nbeen the subject of repeated discussions. It has finally been\nagreed that the HSC should be composed of one designated\nrepresentative of each Member State and one alternate, who should\nmeet in plenary meetings. Membership of the HSC will therefore be\nnominative and will not generally be ensured by authorities of\nMember States.
\nThe Council took stock of progress made on a\ndraft decision aimed at strengthening EU capacities and structures\nfor effectively responding to serious cross-border health threats,\nand gave the Irish Presidency a basis on which to start\nnegotiations.
\nUnder the Cypriot Presidency, good progress has been\nachieved and the draft decision has been amended in line with\nMember States' comments. The changes proposed by the Cypriot\nPresidency:
\nHowever, the Commission considers that its proposal\nhas been weakened in several\nrespects, which makes it difficult for the Commission to accept the\ndirection in which the consensus among the Member States is\nmoving.
\nThis is in particular the case as regards preparedness\nplanning and the possibility to provide a \"safety net\" via\n\"temporary public health measures\". The Commission has therefore\nreserved its position on related articles.
\nA few issues still remain open and further discussions are needed in order to reach\nagreement in the Council ahead of possible negotiations with the\nEuropean Parliament with a view to a first reading agreement.\nThe main changes introduced during the Cypriot Presidency,\nalso focusing on the open questions, are described\nbelow:
\nScope: it has been\nclarified that it does not include threats from ionizing radiation\nas these are sufficiently covered by the Treaty establishing the\nEuropean Atomic Energy Community. In the event of exceptional\nemergencies, the structures to be established by the draft Decision\nshould also be available to the Member States and the Commission\nfor threats that are not covered by the scope of this draft\nDecision.
\nPreparedness and response planning: the question of empowering the Commission to adopt\nimplementing acts to determine the procedures necessary for the\nexchange of information and mutual consultation among Member States\nin accordance with Article 4 has been extensively debated. The\nPresidency is now proposing to delete Article 4(5) and to instruct\nthe HSC in Article 17(5) (e) to adopt those procedures. This is\nsupported by a majority of the Member States, while some Member\nStates are opposed to this proposal.
\nJoint procurement of medical\ncountermeasures: the introduction of\na voluntary system for joint procurement of medical\ncountermeasures, especially pandemic vaccines, should contribute to\nfairer access to them for the Member States participating.\nNevertheless, a few Member States cannot agree to this article and\nare calling for the Commission to propose a separate\ndecision.
\nEpidemiological surveillance: in line with the judgment of the Court of Justice of\nthe EU, the criteria for the selection of communicable diseases and\nspecial health issues to be covered by the Community Network as\ncurrently set out in Annex II to Commission Decision 2000/96/EC\nhave been stipulated in the Annex to the draft decision.
\nAd hocmonitoring: the\nCommission's proposal to set up an ad hoc monitoring network\nby means of implementing acts for health threats other than\ncommunicable diseases and special health issues permanently\nmonitored by the Union's Early Warning and Response System (e.g.\nthreats of chemical, environmental or unknown origin), has not\nreceived support.
\nPublic health risk assessment: according to the current version of the article, the\nCommission shall, upon request of the Health Security Committee, or\non its own initiative, ask the Member States to propose through\nsingle contact points independent experts for an ad hoc\nnomination by the Commission to establish risk assessment where\nexpertise beyond the mandate of the EU agencies is\nneeded.
\nCoordination of response: this article, which was largely agreed on during the\nDanish Presidency, was subject to an addition stipulating that\nMember States shall not be obliged to submit information the\ndisclosure of which they consider contrary to essential interests\nof their security.
\nRecognition of emergency situations: the text now states that a recognition of emergency,\napplicable only to the EU, can be made by the Commission if the WHO\nhas not yet reacted, the cross-border health threat is rapidly\nspreading across the Union and can be prevented by medicinal\nproducts.
\nConclusion of international agreements: a recital has been added to clarify that conclusion\nof international cooperation agreements may be in the interest of\nthe Union in order to foster the exchange of relevant information\nfrom monitoring and alerting systems on serious cross-border\nthreats to health.
\nEstablishment of the Health Security Committee\n(HSC): the composition of the HSC has\nbeen the subject of repeated discussions. It has finally been\nagreed that the HSC should be composed of one designated\nrepresentative of each Member State and one alternate, who should\nmeet in plenary meetings. Membership of the HSC will therefore be\nnominative and will not generally be ensured by authorities of\nMember States.
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\n\nOpinion of the European Data Protection\nSupervisor on the proposal for a decision of the European\nParliament and of the Council on serious cross-border threats to\nhealth
\nThe Proposal aims at replacing Decision 2119/98/EC\nsetting up a network for the epidemiological surveillance and\ncontrol of communicable diseases in the Community, which is the\ncurrent legal basis for the Early Warning and Response System\n(‘EWRS’). The latter has been the subject of a prior\ncheck Opinion of the EDPS.
\nThe EDPS welcomes the references to Regulation (EC) No\n45/2001 and Directive 95/46/EC in Article 18 of the proposal and\nthe fact that the reference to the applicable data protection\nlegislation inArticle 18 now encompasses all personal data\nprocessing under the scope of the proposal. He also welcomes the\nspecific data protection safeguards for contact tracing set forth,\nor required to be adopted by the Commission, under Article\n18.
\nHowever, the following elements of the Proposal still\nrequire, or would benefit from, clarification, further detail or\nother improvements from the point of view of data\nprotection:
\n\n· \ncontact tracing,
\n\n· \nad hoc surveillance,
\n\n· \ncontroller-processor relationship,
\n\n· \nretention period, and
\n\n· \nsecurity measures.
\nThe EDPS notes that several aspects of the proposal\nare not elaborated in the text itself, but will be the subject of\ndelegated and implementing acts, such as the list of communicable\ndiseases to which the proposal shall apply and the procedures for\nthe information exchange in the EWRS. Other aspects will be\nclarified in guidelines and recommendations to be adopted by the\nCommission, such as the data protection guidelines for the\nEWRS.
\nWhilst details can of course be regulated in delegated\nand implementing acts, and such additional provisions are certainly\nof great benefit, the EDPS recommends that the proposal itself also\nprovide more guidance on some of the points mentioned\nabove.
\nRecommendations: in\ngeneral, the EDPS recommends that some essential elements,\nincluding certain essential data protection safeguards, should be\nalso included in the text of the proposal itself. In addition, some\nclarifications are also necessary due to the expansion of the scope\nof the proposal to additional health threats beyond communicable\ndiseases, which have not been subject to the prior checking\nprocedure and also not discussed in the guidelines.
\nMore particularly, the EDPS recommends that the\nProposal should:
\nLes ministres ont\ntenu un débat d'orientation sur le projet de\ndécision visant à renforcer les capacités et\nles structures de l'UE pour réagir efficacement aux menaces\ntransfrontières graves pour la santé. La\nPrésidence a notamment axé sa réflexion sur un\ndocument\nd’ensemble qui devait être débattu lors du\nConseil du 21 juin 2012.
\nÉtat des\nlieux des travaux : les États membres ont\nsouligné l'importance que revêt la préparation\nà l'égard des menaces transfrontières graves\npour la santé et estiment que cette préparation\npourrait être assurée par la coordination et\nl'échange d'informations entre États membres dans le\ncadre du Comité de sécurité sanitaire\n(CSS), plutôt que par une obligation de consultations\npréalables ou des recommandations de la Commission. Cela a\nété jugé important pour assurer le respect des\ncompétences nationales dans le domaine de la santé\nainsi que la conformité à l'article 168 du\ntraité sur le fonctionnement de l'UE.
\nLes ministres ont\nsoutenu la proposition de la Commission visant à\nconférer au Comité de sécurité\nsanitaire (CSS) un mandat juridique. S'agissant de la\ncomposition de ce premier comité, la plupart des ministres\nont plaidé en faveur d'un comité permanent de\nhauts représentants nommés par les\nautorités sanitaires publiques avec la possibilité\nd'inviter des experts au cas par cas.
\nLes États\nmembres ont confirmé leur souhait de supprimer l'article\n12 de la proposition de la Commission, qui prévoit la\npossibilité d'adopter au niveau de l'UE des mesures communes\net temporaires de santé publique qui soient\ncontraignantes. Ils ont été d'accord pour\nestimer, au contraire, que les États membres devraient\nréagir aux cas urgents de menaces transfrontières\ngraves via le CSS.
\nLes discussions ont\npermis de dégager des orientations pour les travaux futurs\nsur ce dossier, qui se poursuivront sous la présidence\nchypriote.
\nPoint de vue de\nla Commission sur le compromis du Conseil : pour sa part,\nla Commission s’est exprimée sur l’état de\nce dossier au Conseil et a mis en lumière sont point de\nvue:
\nMinisters held an orientation debate on\na draft decision aimed at strengthening EU capacities and\nstructures for effectively responding to serious cross-border\nhealth threats.
\nState of play: Member states stressed the importance of\npreparedness against serious cross-border threats to health, and\nconsidered that it could be achieved through coordination and\nthe exchange of information between member states within the health\nsecurity committee (HSC), rather than an obligation for prior\nconsultations or recommendations by the Commission. This was\nregarded important in order to respect national competencies in the\nfield of health and to be in line with article 168 of the Treaty on\nthe Functioning of the EU.
\nMinisters supported the Commission proposal to\nprovide a legal mandate to the health security committee. As\nregards the composition of this committee, most ministers argued\nfor a standing committee of high representatives nominated\nby public health authorities with the possibility of inviting\nexperts on a case-by-case basis.
\nMember states confirmed their wish to delete\narticle 12 of the Commission proposal which envisages the\npossibility of binding common temporary public health measures at\nEU level. Instead they shared the view that member states\nshould deal with urgent cases of cross-border health threats\nthrough the HSC.
\nThe discussion gave guidance for future work on\nthis file that will continue during the incoming Cyprus\npresidency.
\nThe\nCommission’s point of view on the Council’s compromise\ntext: the Commission considers that:
\nOBJECTIF :\nétablir une initiative européenne destinée\nà lutter contre les menaces transfrontières graves\npour la santé.
\nACTE PROPOSÉ\n: Décision du Parlement européen et du Conseil.
\nCONTEXTE : de\nnombreuses activités liées à la planification\nde la préparation et de l’intervention et à\nl’évaluation des risques relative aux maladies\ntransmissibles, mais aussi aux menaces pour la santé\nd’origine chimique et aux événements\ncausés par le changement climatique, ont été\nsoutenues au plan européen, notamment via l’actuel\nréseau de surveillance épidémiologique et de\ncontrôle des maladies transmissibles (voir Décision\n2119/98/CE du Parlement et du Conseil instaurant un\nréseau de surveillance épidémiologique et de\ncontrôle des maladies transmissibles dans la\nCommunauté). L’UE dispose notamment de politiques, de\nmécanismes et d’instruments permettant la\nprévention et le contrôle des menaces\ntransfrontières graves et le développement de\ncapacités de gestion des crises (mécanisme de\nprotection civile de l’UE, Fonds de cohésion et de\nsolidarité, plan d’action de l’UE en\nmatière de sécurité chimique, biologique,\nradiologique et nucléaire et réseaux d’alerte\neuropéens comme Ecurie).
\nAfin\nd’éviter les chevauchements avec ces domaines et la\nduplication des structures actuelles de prévention et de\ncontrôle des catastrophes, il a été\nprocédé à une analyse des écarts afin\nde déterminer dans quelle mesure les systèmes\nexistants assuraient la surveillance et la notification des menaces\npour la santé et l’évaluation des risques y\nafférents, et pour vérifier leurs capacités et\nstructures de gestion des crises touchant à la santé\npublique. Cette analyse a révélé que les\nstructures et mécanismes actuels au niveau de l’UE ne\ntraitent pas ces menaces assez efficacement sur le plan de la\nsanté publique.
\nCette lacune est\nsource de disparités dans la manière\nd’apprécier le danger que représente une menace\ndonnée, débouche sur la redondance des\névaluations menées dans les différents\nÉtats membres et conduit à l’adoption de mesures\nincohérentes à l’échelle de l’Union.\nCette situation peut aussi entraîner l’utilisation\ninefficace des ressources limitées actuellement\ndisponibles.
\nBien\nqu’il incombe aux États membres de gérer les\ncrises de santé publique à l’échelon\nnational, aucun pays ne peut à lui seul combattre une crise\ninternationale en matière de santé publique. Au\nniveau de l’UE, les dispositions juridiques régissant\nla lutte contre les menaces transfrontières graves pour la\nsanté ont été renforcées par le\ntraité de Lisbonne. L’UE peut désormais adopter\ndes mesures dans ce domaine, pour compléter et appuyer les\npolitiques nationales et encourager la coopération entre les\nÉtats membres.
\nC’est la\nraison pour laquelle, il est proposé de créer un\nnouvel instrument destiné à intensifier la\ncoopération et à renforcer la coordination dans le\ndomaine de la notification et de l’évaluation des\nrisques. L’objectif est de rationaliser et renforcer les\ncapacités et les structures de l’Union\neuropéenne afin de répondre efficacement aux\nmenaces transfrontières graves pour la santé, quelle\nqu’en soit la nature : menaces liées à des\névénements causés par des maladies\ntransmissibles ou des agents biologiques, menaces d’origine\nchimique ou environnementale ou encore menaces dues aux effets du\nchangement climatique.
\nANALYSE\nD’IMPACT : la Commission a procédé à\nl’analyse détaillée de 3 options:
\nLes\nrésultats de l’analyse ont abouti à la\nconclusion que l’option 3 avait les effets les plus\npositifs en matière de santé, car elle\ncontribuait à améliorer la protection des citoyens\ncontre les menaces transfrontières graves pour la\nsanté.
\nBASE JURIDIQUE :\narticle 168, par. 4, point c), et par. 5 du traité sur le\nfonctionnement de l’Union européenne (TFUE).
\nCONTENU : la\nprésente proposition établit les règles\nrelatives à la surveillance des menaces\ntransfrontières graves pour la santé, à\nl’alerte en cas de telles menaces et à la lutte contre\ncelles-ci, ainsi que celles relatives à la planification de\nla préparation et de l’intervention liées\nà ces activités. Elle vise à favoriser la\nprévention de maladies humaines graves et la lutte contre\nleur propagation transfrontière dans les États\nmembres, et à prévenir d’autres sources majeures\nde menace transfrontière grave pour la santé afin de\ncontribuer à un niveau élevé de protection de\nla santé publique dans l’Union.
\nChamp\nd’application : la proposition s’applique dans\nles cas de menaces transfrontières graves pour la\nsanté relevant des catégories suivantes:
\nStructure\ngénérale : le système de surveillance\ns’articule autour des 4 grands domaines suivants :
\n\n1) dans\nle domaine de la planification de la préparation, la\nproposition prévoit la coordination des efforts des\nÉtats membres en ce qui concerne l’amélioration\nde la préparation et le renforcement des capacités.\nÀ cette fin, la Commission assurera la coordination entre\nles systèmes de planification nationaux et entre les\nsecteurs clés, tels que le transport, l’énergie\net la protection civile. Dans le cadre de cette planification, il\nest prévu d’instituer une procédure conjointe\nde passation de marché relative à des\ncontre-mesures médicales au niveau de l’UE, auquel les\nparties contractantes pourraient participer à titre\nvolontaire pour acheter des contre-mesures médicales, par\nexemple des vaccins contre la grippe pandémique, ce qui\npermettrait à l’UE d’être mieux\npréparée aux futures pandémies ;
\n\n2) la\nmise en place d’un réseau de surveillance\népidémiologique afin de fournir les informations et\ndonnées nécessaires à l’évaluation\ndes risques : ce réseau ad hoc serait mis en\nplace lorsqu’un État membre signalera une menace grave\nautre qu’une maladie transmissible. Les maladies\ntransmissibles continueront à être surveillées\ncomme actuellement ;
\n\n3) \nl’utilisation du système actuel d’alerte\nprécoce et de réaction pour qu’il couvre\ntoutes les menaces graves pour la santé, et pas uniquement\nles maladies transmissibles comme c’est le cas\naujourd’hui ;
\n\n4) la\nréalisation coordonnée d’évaluations\nnationales ou européennes des risques que\nprésentent pour la santé les menaces d’origine\nbiologique, chimique, environnementale ou inconnue en situation de\ncrise.
\nRéaction\nsanitaire européenne : la proposition\nétablit en outre un cadre cohérent régissant\nla réaction de l’UE en cas de crise de santé\npublique. Concrètement, en officialisant le\ncomité de sécurité sanitaire existant,\nl’UE sera mieux à même de coordonner les\nréactions nationales en cas d’urgence de santé\npublique. Une procédure de mobilisation et de coordination\nde la réaction européenne face à une menace\nsanitaire grave est ainsi proposée. Ainsi, si un État\nmembre a l’intention d’adopter des mesures de\nsanté publique pour lutter contre une menace\ntransfrontière grave pour la santé, il doit, avant\nd’adopter ces mesures, consulter les autres États\nmembres et la Commission au sujet de la nature, de l’objet et\ndu champ d’application des mesures. Les mesures prises sont\nalors décidées, par voie d’actes\nd’exécution.
\nSont\négalement prévues les mesures spécifiques\nsuivantes :
\nINCIDENCE\nBUDGÉTAIRE : la proposition n’a pas d’incidence\nsur les agences décentralisées. Le programme actuel\nde l’UE en matière de santé comprend\ndéjà des activités liées à la\nsurveillance, à l’alerte et à\nl’évaluation des risques en ce qui concerne certaines\nmenaces pour la santé. Après 2013, la Commission a\nl’intention d’inclure ces activités dans le\nprogramme «Santé en faveur de la croissance»\nproposé pour la période 2014-2020. Les coûts\ncorrespondants seront compris dans l’enveloppe proposée\npour le nouveau programme.
\nACTES\nDÉLÉGUÉS : le pouvoir d’adopter des\nactes délégués conformément à\nl’article 290 du TFUE devrait être conféré\nà la Commission en ce qui concerne les mesures\nnécessaires pour compléter l’action des\nÉtats membres, dans des situations d’urgence\ntrès spécifiques, à l’égard\ndes aspects transnationaux de la lutte contre les menaces\ntransfrontières graves pour la santé. Afin de\ngarantir des conditions uniformes d’exécution de la\nprésente proposition, les compétences\nd’exécution seraient conférées à\nla Commission en vue de l’adoption d’actes\nd’exécution en ce qui concerne:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nThe Council took stock of progress made on a\ndraft decision aimed at strengthening EU capacities and structures\nfor effectively responding to serious cross-border health threats,\nand gave the Irish Presidency a basis on which to start\nnegotiations.
\nUnder the Cypriot Presidency, good progress has been\nachieved and the draft decision has been amended in line with\nMember States' comments. The changes proposed by the Cypriot\nPresidency:
\nHowever, the Commission considers that its proposal\nhas been weakened in several\nrespects, which makes it difficult for the Commission to accept the\ndirection in which the consensus among the Member States is\nmoving.
\nThis is in particular the case as regards preparedness\nplanning and the possibility to provide a \"safety net\" via\n\"temporary public health measures\". The Commission has therefore\nreserved its position on related articles.
\nA few issues still remain open and further discussions are needed in order to reach\nagreement in the Council ahead of possible negotiations with the\nEuropean Parliament with a view to a first reading agreement.\nThe main changes introduced during the Cypriot Presidency,\nalso focusing on the open questions, are described\nbelow:
\nScope: it has been\nclarified that it does not include threats from ionizing radiation\nas these are sufficiently covered by the Treaty establishing the\nEuropean Atomic Energy Community. In the event of exceptional\nemergencies, the structures to be established by the draft Decision\nshould also be available to the Member States and the Commission\nfor threats that are not covered by the scope of this draft\nDecision.
\nPreparedness and response planning: the question of empowering the Commission to adopt\nimplementing acts to determine the procedures necessary for the\nexchange of information and mutual consultation among Member States\nin accordance with Article 4 has been extensively debated. The\nPresidency is now proposing to delete Article 4(5) and to instruct\nthe HSC in Article 17(5) (e) to adopt those procedures. This is\nsupported by a majority of the Member States, while some Member\nStates are opposed to this proposal.
\nJoint procurement of medical\ncountermeasures: the introduction of\na voluntary system for joint procurement of medical\ncountermeasures, especially pandemic vaccines, should contribute to\nfairer access to them for the Member States participating.\nNevertheless, a few Member States cannot agree to this article and\nare calling for the Commission to propose a separate\ndecision.
\nEpidemiological surveillance: in line with the judgment of the Court of Justice of\nthe EU, the criteria for the selection of communicable diseases and\nspecial health issues to be covered by the Community Network as\ncurrently set out in Annex II to Commission Decision 2000/96/EC\nhave been stipulated in the Annex to the draft decision.
\nAd hocmonitoring: the\nCommission's proposal to set up an ad hoc monitoring network\nby means of implementing acts for health threats other than\ncommunicable diseases and special health issues permanently\nmonitored by the Union's Early Warning and Response System (e.g.\nthreats of chemical, environmental or unknown origin), has not\nreceived support.
\nPublic health risk assessment: according to the current version of the article, the\nCommission shall, upon request of the Health Security Committee, or\non its own initiative, ask the Member States to propose through\nsingle contact points independent experts for an ad hoc\nnomination by the Commission to establish risk assessment where\nexpertise beyond the mandate of the EU agencies is\nneeded.
\nCoordination of response: this article, which was largely agreed on during the\nDanish Presidency, was subject to an addition stipulating that\nMember States shall not be obliged to submit information the\ndisclosure of which they consider contrary to essential interests\nof their security.
\nRecognition of emergency situations: the text now states that a recognition of emergency,\napplicable only to the EU, can be made by the Commission if the WHO\nhas not yet reacted, the cross-border health threat is rapidly\nspreading across the Union and can be prevented by medicinal\nproducts.
\nConclusion of international agreements: a recital has been added to clarify that conclusion\nof international cooperation agreements may be in the interest of\nthe Union in order to foster the exchange of relevant information\nfrom monitoring and alerting systems on serious cross-border\nthreats to health.
\nEstablishment of the Health Security Committee\n(HSC): the composition of the HSC has\nbeen the subject of repeated discussions. It has finally been\nagreed that the HSC should be composed of one designated\nrepresentative of each Member State and one alternate, who should\nmeet in plenary meetings. Membership of the HSC will therefore be\nnominative and will not generally be ensured by authorities of\nMember States.
\nThe Council took stock of progress made on a\ndraft decision aimed at strengthening EU capacities and structures\nfor effectively responding to serious cross-border health threats,\nand gave the Irish Presidency a basis on which to start\nnegotiations.
\nUnder the Cypriot Presidency, good progress has been\nachieved and the draft decision has been amended in line with\nMember States' comments. The changes proposed by the Cypriot\nPresidency:
\nHowever, the Commission considers that its proposal\nhas been weakened in several\nrespects, which makes it difficult for the Commission to accept the\ndirection in which the consensus among the Member States is\nmoving.
\nThis is in particular the case as regards preparedness\nplanning and the possibility to provide a \"safety net\" via\n\"temporary public health measures\". The Commission has therefore\nreserved its position on related articles.
\nA few issues still remain open and further discussions are needed in order to reach\nagreement in the Council ahead of possible negotiations with the\nEuropean Parliament with a view to a first reading agreement.\nThe main changes introduced during the Cypriot Presidency,\nalso focusing on the open questions, are described\nbelow:
\nScope: it has been\nclarified that it does not include threats from ionizing radiation\nas these are sufficiently covered by the Treaty establishing the\nEuropean Atomic Energy Community. In the event of exceptional\nemergencies, the structures to be established by the draft Decision\nshould also be available to the Member States and the Commission\nfor threats that are not covered by the scope of this draft\nDecision.
\nPreparedness and response planning: the question of empowering the Commission to adopt\nimplementing acts to determine the procedures necessary for the\nexchange of information and mutual consultation among Member States\nin accordance with Article 4 has been extensively debated. The\nPresidency is now proposing to delete Article 4(5) and to instruct\nthe HSC in Article 17(5) (e) to adopt those procedures. This is\nsupported by a majority of the Member States, while some Member\nStates are opposed to this proposal.
\nJoint procurement of medical\ncountermeasures: the introduction of\na voluntary system for joint procurement of medical\ncountermeasures, especially pandemic vaccines, should contribute to\nfairer access to them for the Member States participating.\nNevertheless, a few Member States cannot agree to this article and\nare calling for the Commission to propose a separate\ndecision.
\nEpidemiological surveillance: in line with the judgment of the Court of Justice of\nthe EU, the criteria for the selection of communicable diseases and\nspecial health issues to be covered by the Community Network as\ncurrently set out in Annex II to Commission Decision 2000/96/EC\nhave been stipulated in the Annex to the draft decision.
\nAd hocmonitoring: the\nCommission's proposal to set up an ad hoc monitoring network\nby means of implementing acts for health threats other than\ncommunicable diseases and special health issues permanently\nmonitored by the Union's Early Warning and Response System (e.g.\nthreats of chemical, environmental or unknown origin), has not\nreceived support.
\nPublic health risk assessment: according to the current version of the article, the\nCommission shall, upon request of the Health Security Committee, or\non its own initiative, ask the Member States to propose through\nsingle contact points independent experts for an ad hoc\nnomination by the Commission to establish risk assessment where\nexpertise beyond the mandate of the EU agencies is\nneeded.
\nCoordination of response: this article, which was largely agreed on during the\nDanish Presidency, was subject to an addition stipulating that\nMember States shall not be obliged to submit information the\ndisclosure of which they consider contrary to essential interests\nof their security.
\nRecognition of emergency situations: the text now states that a recognition of emergency,\napplicable only to the EU, can be made by the Commission if the WHO\nhas not yet reacted, the cross-border health threat is rapidly\nspreading across the Union and can be prevented by medicinal\nproducts.
\nConclusion of international agreements: a recital has been added to clarify that conclusion\nof international cooperation agreements may be in the interest of\nthe Union in order to foster the exchange of relevant information\nfrom monitoring and alerting systems on serious cross-border\nthreats to health.
\nEstablishment of the Health Security Committee\n(HSC): the composition of the HSC has\nbeen the subject of repeated discussions. It has finally been\nagreed that the HSC should be composed of one designated\nrepresentative of each Member State and one alternate, who should\nmeet in plenary meetings. Membership of the HSC will therefore be\nnominative and will not generally be ensured by authorities of\nMember States.
\nMinisters held an orientation debate on\na draft decision aimed at strengthening EU capacities and\nstructures for effectively responding to serious cross-border\nhealth threats.
\nState of play: Member states stressed the importance of\npreparedness against serious cross-border threats to health, and\nconsidered that it could be achieved through coordination and\nthe exchange of information between member states within the health\nsecurity committee (HSC), rather than an obligation for prior\nconsultations or recommendations by the Commission. This was\nregarded important in order to respect national competencies in the\nfield of health and to be in line with article 168 of the Treaty on\nthe Functioning of the EU.
\nMinisters supported the Commission proposal to\nprovide a legal mandate to the health security committee. As\nregards the composition of this committee, most ministers argued\nfor a standing committee of high representatives nominated\nby public health authorities with the possibility of inviting\nexperts on a case-by-case basis.
\nMember states confirmed their wish to delete\narticle 12 of the Commission proposal which envisages the\npossibility of binding common temporary public health measures at\nEU level. Instead they shared the view that member states\nshould deal with urgent cases of cross-border health threats\nthrough the HSC.
\nThe discussion gave guidance for future work on\nthis file that will continue during the incoming Cyprus\npresidency.
\nThe\nCommission’s point of view on the Council’s compromise\ntext: the Commission considers that:
\nMinisters held an orientation debate on\na draft decision aimed at strengthening EU capacities and\nstructures for effectively responding to serious cross-border\nhealth threats.
\nState of play: Member states stressed the importance of\npreparedness against serious cross-border threats to health, and\nconsidered that it could be achieved through coordination and\nthe exchange of information between member states within the health\nsecurity committee (HSC), rather than an obligation for prior\nconsultations or recommendations by the Commission. This was\nregarded important in order to respect national competencies in the\nfield of health and to be in line with article 168 of the Treaty on\nthe Functioning of the EU.
\nMinisters supported the Commission proposal to\nprovide a legal mandate to the health security committee. As\nregards the composition of this committee, most ministers argued\nfor a standing committee of high representatives nominated\nby public health authorities with the possibility of inviting\nexperts on a case-by-case basis.
\nMember states confirmed their wish to delete\narticle 12 of the Commission proposal which envisages the\npossibility of binding common temporary public health measures at\nEU level. Instead they shared the view that member states\nshould deal with urgent cases of cross-border health threats\nthrough the HSC.
\nThe discussion gave guidance for future work on\nthis file that will continue during the incoming Cyprus\npresidency.
\nThe\nCommission’s point of view on the Council’s compromise\ntext: the Commission considers that:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nPURPOSE: establish a\nEuropean initiative to combat serious cross-border threats to\nhealth.
\nPROPOSED ACT: Decision of\nthe European Parliament and of the Council.
\nBACKGROUND: many activities related to preparedness\nand response planning and risk assessment for communicable diseases\nbut also for chemical threats to health and events caused by\nclimate change have been supported at European level, in particular\nthe current Community network for the epidemiological surveillance\nand control of communicable diseases (see Decision No 2119/98/EC of the\nEuropean Parliament and the Council establishing a network for the epidemiological\nsurveillance and control of communicable diseases in the\nCommunity). The EU already has policies, mechanisms and instruments\nin place for the prevention and control of serious cross-border\nthreats and for the development of capacities to manage crises. A\nnon-exhaustive list includes the EU Civil Protection Mechanism, the\nCohesion and Solidarity Funds, the EU action plan on chemical,\nbiological, radiological and nuclear security, and European alert\nnetworks, such as ECURIE.
\nIn order to avoid overlaps with these areas and\nduplicating existing disaster prevention and control structures, a\ngap analysis has been carried out to assess how far these existing\nsystems cover the monitoring of threats to health, their\nnotification, risk assessment and crisis management capacities and\nstructures from the public health perspective. This gap analysis\nrevealed that the existing structures and mechanisms at EU level\ndo not address these threats sufficiently as far as public health\nis concerned.
\nThe lack of public health risk assessment at EU level\nleads to discrepancies in evaluating the danger of a given threat,\nduplication of assessments between Member States and inconsistent\nmeasures at EU level. Such a situation can also lead to inefficient\nuse of the limited resources currently available.
\nAlthough the Member States have the responsibility to\nmanage public health crises at national level, no country can\ntackle a cross border public health crisis on its own. At EU level,\nthe legal basis for addressing serious cross-border health threats\nhas been reinforced with the Lisbon Treaty. The EU can now take\naction in this field that complement and support national policies\nand encourage cooperation between Member States.
\nThis is the reason why it is proposed to create a new\ninstrument to step up cooperation and strengthen coordination in\nthe area of the notification and risk assessment.
\nThe aim is to streamline and strengthen European\nUnion capacities and structures for effectively responding to\nserious cross-border health threats. These threats can be events\ncaused by communicable diseases, biological agents responsible for\nnon-communicable diseases, and threats of chemical, environmental,\nor unknown origin, as well as threats deriving from the effects of\nclimate change.
\nIMPACT ASSESSMENT:
\nThe Commission has carried out detailed analysis of\nthree options:
\nThe results of the analysis led to the conclusion that\noption 3 has the strongest positive health impacts as it\nimproves the protection of citizens against serious cross-border\nthreats to health.
\nLEGAL BASIS: Article 168,\nparagraphs (4)(c) and (5) of the Treaty on the Functioning of the\nEuropean Union (TFEU).
\nCONTENT: this proposal lays down the rules on\nmonitoring, early warning of and combating serious cross-border\nthreats to health, as well as on preparedness and response planning\nrelated to those activities. It aims to support the prevention and\ncontrol of the spread of severe human diseases across the borders\nof the Member States, and to obviate other major sources of serious\ncross-border threat to health in order to contribute to a high\nlevel of public health protection in the Union.
\nScope: the proposal applies in case of serious cross-border\nthreats to health falling within the following\ncategories:
\nGeneral\nstructure: the monitoring system\nrevolves around the following four fields:
\n\n1) \npreparedness and response\nplanning: the proposal provides for\nthe coordination of the efforts of the Member States in terms of\nimproved preparedness and capacity building. To this end, the\nCommission will ensure coordination between national planning and\nbetween key sectors such as transport, energy and civil protection,\nand will support Member States in setting up a joint procurement\nmechanism for medical countermeasures, e.g. vaccines against\ninfluenza, which would enable the EU to be better prepared for\nfuture pandemics;
\n\n2) \nestablishment of an epidemiological\nmonitoring network: to provide the\nrelevant information and data for risk assessment and monitoring of\nemerging threats, an ad hoc network will be set up in situations\nwhere a Member State has raised an alert on a serious threat other\nthan a communicable disease. Communicable diseases will continue to\nbe monitored as they are today;
\n\n3) \nthe use of the existing Early Warning and\nResponse System to cover all serious\nthreats to health, and not only communicable diseases as is the\ncase today;
\n\n4) \ncoordinated development of national or\nEuropean public health risk assessments for threats of biological, chemical, environmental or\nunknown origin in a crisis situation.
\nEU response to a public health crisis:\nthe proposal sets up a coherent framework for\nthe EU response to a public health crisis. In concrete\nterms, by formalising the existing Health Security Committee, the\nEU will be in a better position to coordinate national crisis\nresponses in a public health emergency. A procedure for the\nmobilisation and coordination of the European response to a serious\ncross-border risk is proposed. Thus, if a Member State intends to\nadopt public health measures to combat a serious cross-border\nhealth risk, it shall, before adopting any measures consult the\nother Member States and the Commission on the nature, purpose and\nscope of the measures. The measures taken shall be decided by means\nof implementing acts.
\nProvision is also made for the following specific\nmeasures:
\nBUDGETARY IMPACT: this legal proposal does not impact\non decentralised agencies. In addition, the current EU health\nprogramme already covers some activities in relation to monitoring,\nalerting and risk assessment of some health threats. After 2013,\nthe Commission intends to cover these activities under the proposed\nHealth for growth programme 2014-2020. The cost is included in the\nproposed envelope of the new programme.
\nDELEGATED ACTS: in accordance with Article 290 of the\nTFEU, the Commission should be empowered to adopt delegated acts in\nrespect of measures needed to complement the action of the Member\nStates, in very specific and urgent situations, for the\ntransnational aspects of the control of serious cross-border\nthreats to health. In order to ensure uniform conditions for the\nimplementation of this Decision, implementing powers should be\nconferred on the Commission to adopt implementing acts in relation\nto:
\nThe Committee on Foreign Affairs adopted the\nown-initiative report drafted by Dominique BAUDIS (EPP, FR) on\nEuropean Union relations with the Gulf Cooperation Council\n(GCC).
\nFirstly, the report recalls\nthat its geopolitical environment makes the Gulf a focus of\nsecurity challenges that have global and regional implications (the\nMiddle East peace process, Iran's nuclear programme, the\nstabilisation of Iraq, Yemen and Darfur, terrorism and piracy). It\nstates that the GCC is still the only stable regional organisation\nbased on multilateralism and cooperation. In this context, Members\nemphasise that concluding the free trade agreement between the\nEU and the GCC remains a priority and that failure to conclude\nit would not be in either party's interests.
\nGiven the limited presence\nof the Union in the Gulf region, the EU needs to develop a strategy\nfor the region aimed at strengthening its ties with the GCC,\nsupporting the regional integration process, and encouraging\nbilateral relations with the GCC member states. The objective is a strategic partnership with\nthe GCC and its member states commensurate with the respective\nroles of the two entities on the international\nstage.
\nMembers call for the\nEuropean External Action Service (EEAS) to devote more human\nresources to the region and for new EU diplomatic missions to be\nopened in the GCC member states. They stress that these resources\nshould stem principally from a reallocation of staff within the\nEEAS. They also stress that tailored bilateral approaches to GCC\nmember states minded to engage in closer cooperation with the EU\ncan only complement and strengthen the multilateral\nframework.
\nMembers encourage all these\nstates to sustain their efforts and to do more to promote human\nrights, to combat discrimination of all kinds, including\ndiscrimination based on gender, sexual orientation and religion.\nThey invite the GCC member states to safeguard and promote the\nrights of minorities - including religious minorities - gender\nequality, the right to work - including for migrant workers - and\nfreedom of conscience, expression and opinion. A continuous\ndialogue on these issues is called for with the aim to:
\nIn parallel, obstacles to\nthe full and effective exercise of the fundamental right of\nreligious freedom should be removed. Members also reinstate the\nEU's opposition to the death penalty and Parliament's call\nfor a global moratorium on it.
\nJoint Action\nProgramme: Members note the\nthree-year Joint Action Programme adopted by the EU-GCC Joint\nCouncil and Ministerial Meeting on 14 June 2010 which is intended\nto strengthen cooperation in many strategic areas of mutual\ninterest. They consider that the implementation of this Joint\nAction Programme should be accompanied by a precise and detailed\nfunding scheme. They stress the importance of ensuring the\nvisibility of this programme and that an evaluation of the results\nshould be carried. Members call on the EU to focus its cooperation\nprogrammes with the GCC member states more on civil society\norganisations and to support the empowerment of women and\nyouth.
\nMiddle-East: Members\nexpress their profound concern at seeing the Gulf region caught up\nin an arms race and ask the EU to initiate a strategic dialogue\nwith the GCC member states on regional security issues of common\ninterest (the Middle East peace process, Iran's nuclear programme,\nthe stabilisation of Iraq, Yemen and Darfur, terrorism and piracy).\nThey call for a regional security structure in the Middle\nEast to be built in partnership with the Gulf states. The\nreport emphasises that it is in the common interest of the EU and\nthe GCC to promote peace and stability in the Middle East, North\nAfrica and the Horn of Africa, and globally. It urges the partners\nto strengthen cooperation on this matter of common\ninterest.
\nMembers reiterate their\nsupport for the Arab peace initiative put forward by one of the GCC\nmember states and call on the GCC member states to continue their\nmediation efforts and support for the Israeli-Palestinian peace\nprocess. They call on the EU and the GCC to step up joint efforts\nto bring about a negotiated end to the occupation of the\nPalestinian Territories, while continuing to provide full\nsupport for a two-state solution to the Israel/Palestine conflict.\nMembers call on the GCC member states to contribute more to\nstrengthening Palestinian institutions and to economic development,\nwithin the context of the Palestinian Authority's government\nprogramme, and to consider paying their financial contributions\nthrough existing international aid mechanisms, where\nappropriate.
\nTrade\nrelations: recalling its resolution\nof 24 April 2008 on the Free Trade Agreement (FTA) between the EC\nand the GCC, Members deplore the fact that negotiations between the\nEU and the GCC (EU-GCC FTA) have suffered repeated lengthy delays.\nThey also deplore the GCC's decision to suspend these negotiations\nin 2008. They believe that it is high time to unblock\nthese negotiations so that a definitive solution can be found.\nAfter 20 years of negotiations, the FTA has still to be concluded\ndespite the fact that it should be seen not only as an instrument\nto enhance welfare through trade, but also as a tool to foster\ngeopolitical stability.
\nIn particular, Members call\nfor:
\nMembers reaffirm that the EU's primary objective in its\nrelations with the GCC should be to conclude the FTA, which\nwill be a major region-to-region agreement. They encourage the High\nRepresentative/Vice-President and the Commissioner for Trade to\nassess alternative approaches to future commercial relations with\nthe GCC member states, in the form of bilateral agreements between\nthe EU and the Gulf States that already feel prepared to enter into\nfurther commitments with the EU. They also believe that an\nFTA with the EU would facilitate the further economic\nintegration of the GCC and that, following the establishment of\nthe GCC Customs Union, it may also lend greater impetus to\nimportant projects such as the GCC common market and the completion\nof a GCC monetary union with a single currency.
\nMembers states that the\nfuture FTA should also:
\nMembers propose the\nestablishment of a regular heads of state and government summit\nbetween the EU and the GCC which could enhance the political,\nfinancial, economic, commercial and cultural ties between the EU\nand GCC immensely.
\nMigrant\nworkers: the report notes that there\nare 15 million migrant workers in the six Gulf Cooperation Council\nstates and that those workers make up 40% of the total population.\nMembers recall the precarious situation of migrant workers in the\nGulf States which was highlighted by the International Labour\nOrganisation (ILO) and supports the ILO's call for a minimum wage\nin the region in order to prevent any further deterioration in the\nposition of domestic and migrant workers.
\nEnergy: Members consider that synergies must be encouraged\non the issue of renewable energy. They commend the work\ncarried out by the EU-GCC Energy Expert Group, in particular on\nnatural gas, energy efficiency and nuclear safety and call on the\nCommission, in the light of the challenge of climate change and the\ngrowing energy consumption in both regions, to address energy\nefficiency as one of the main areas of development and to enhance\ncooperation on energy efficiency issues. They\ncall for greater transparency in oil and gas data as regards\nthe future demand and supply scenario, in keeping with the shared\ninterest in predictable oil markets. They recognise that the GCC's\nefforts to increase potential natural gas and liquid natural gas\n(LNG) reserves accord with the EU's desire to diversify energy\nsources and supply routes. They encourage the GCC member states to\ncoordinate the further development of gas-to-liquid (GTL)\ntechnology with their European partners in order better to\nincorporate GTL into the European energy mix. Members also\nemphasise that the EU has opportunities to invest in GCC energy\nproduction capacity, using the latest technologies in terms of\ngeneration, transmission and interconnection.
\nThe report stresses the\nimportance of a reliable partnership between the EU and the GCC in\nthe use of, and access to, raw materials. It favours open markets\nfor goods and the removal of non-tariff barriers. It calls for\njoint efforts to address the speculation and price volatility\naffecting raw materials, through greater transparency and\ncloser supervision of OTC derivatives trading.
\nMembers also make a number\nof recommendations with a view to strengthening bilateral\ncooperation in the following fields:
\nLastly, Members recommend\nthat the EU devote more resources to the GCC via the\ninstrument for cooperation with industrialised and other\nhigh-income countries, which should be made more visible and should\nfocus on suitable programmes for training local civil servants,\nincluding in trade matters.
\nThe European Parliament adopted a resolution on\nEuropean Union relations with the Gulf Cooperation Council\n(GCC).
\nParliament recalls that its geopolitical environment\nmakes the Gulf a focus of security challenges that have global and\nregional implications (the Middle East peace process, Iran's\nnuclear programme, the stabilisation of Iraq, Yemen and Darfur,\nterrorism and piracy). It states that the GCC is still the only\nstable regional organisation based on multilateralism and\ncooperation. In this context, Members emphasise that concluding\nthe free trade agreement between the EU and the GCC remains a\npriority and that failure to conclude it would not be in either\nparty's interests.
\nGiven the limited presence of the Union in the Gulf\nregion, the EU needs to develop a strategy for the region aimed at\nstrengthening its ties with the GCC, supporting the regional\nintegration process, and encouraging bilateral relations with the\nGCC member states. The objective is a\nstrategic partnership with the GCC and its member states\ncommensurate with the respective roles of the two entities on the\ninternational stage.
\nParliament calls for the European External Action\nService (EEAS) to devote more human resources to the region and for\nnew EU diplomatic missions to be opened in the GCC member states.\nIt stresses that these resources should stem principally from a\nreallocation of staff within the EEAS. It also stresses that\ntailored bilateral approaches to GCC member states minded to engage\nin closer cooperation with the EU can only complement and\nstrengthen the multilateral framework.
\nMembers encourage all these states to sustain their\nefforts and to do more to promote human rights, to combat\ndiscrimination of all kinds, including discrimination based on\ngender, sexual orientation and religion. They invite the GCC member\nstates to safeguard and promote the rights of minorities -\nincluding religious minorities - gender equality, the right to work\n- including for migrant workers - and freedom of conscience,\nexpression and opinion. A continuous dialogue on these issues is\ncalled for with the aim to:
\nIn parallel, obstacles to the full and effective\nexercise of the fundamental right of religious freedom should be\nremoved. Members also reinstate the EU's opposition to the death\npenalty and Parliament's call for a global moratorium on\nit.
\nIn a series of oral amendments proposed by the\nRapporteur and adopted in Plenary, Parliament draws attention to\nthe social and political developments that have taken place in\nrecent years in most GCC member states. They take note of the fact\nthat demonstrators have expressed legitimate democratic\naspirations in several GCC States. The resolution recalls that\nthe violent reaction by the authorities to protests in Bahrain\nresulted in deaths, injuries, and imprisonments. Saudi, UAE and\nKuwaiti troops have arrived in the country under the banner of the\nGCC to participate in the repression of demonstrators. Plenary\ncalls on all Member States in the Gulf Cooperation Council to\nrecognise a continuing popular movement for democratic\nreform within the wider region, and calls for the full\nengagement with emerging civil society groups to promote a process\nof genuine peaceful democratic transition, within their own\ncountries, with partners in the region and with the full support of\nthe European Union.
\nAs regards Bahrain, Parliament expresses its deep\nconcern at the violent response of and the use of force against\nprotesters by Bahraini authorities and at the participation of\nforeign troops under the GCC banner in the repression of\ndemonstrators. This stands in stark contrast to the GCC's support\nfor the protection of the citizens demanding freedom and democracy\nin Libya. Parliament calls for an immediate end to violence against\npeaceful protesters and for a political dialogue that can lead to\nfurther necessary political reforms in the country.
\nJoint Action Programme:\nParliament notes the three-year Joint Action Programme adopted by\nthe EU-GCC Joint Council and Ministerial Meeting on 14 June 2010\nwhich is intended to strengthen cooperation in many strategic areas\nof mutual interest. It considers that the implementation of this\nJoint Action Programme should be accompanied by a precise and\ndetailed funding scheme. It stresses the importance of ensuring the\nvisibility of this programme and that an evaluation of the results\nshould be carried. Members call on the EU to focus its cooperation\nprogrammes with the GCC member states more on civil society\norganisations and to support the empowerment of women and\nyouth.
\nMiddle-East: Parliament\nexpresses its profound concern at seeing the Gulf region caught up\nin an arms race and asks the EU to initiate a strategic dialogue\nwith the GCC member states on regional security issues of common\ninterest (the Middle East peace process, Iran's nuclear programme,\nthe stabilisation of Iraq, Yemen and Darfur, terrorism and piracy).\nParliament calls for a regional security structure in the Middle\nEast to be built in partnership with the Gulf states. The\nresolution emphasises that it is in the common interest of the EU\nand the GCC to promote peace and stability in the Middle East,\nNorth Africa and the Horn of Africa, and globally. It urges the\npartners to strengthen cooperation on this matter of common\ninterest. At the same time, Plenary adopted an oral amendment in\nwhich Parliament takes note of the declaration by the GCC of 7\nMarch 2011 in Abu Dhabi, which states that 'the Ministerial council\ndemands that the Security Council takes the steps necessary to\nprotect civilians, including a no-fly zone in Libya', which\ndeclaration has contributed to the decision of the Arab League and\nthen the United Nations Security Council to pronounce themselves in\nfavour of such a zone.
\nIn parallel, Parliament reiterates its support for the\nArab peace initiative put forward by one of the GCC member states\nand calls on the GCC member states to continue their mediation\nefforts and support for the Israeli-Palestinian peace\nprocess.
\nMembers call on the EU and the GCC to step up joint\nefforts to bring about a negotiated end to the occupation of the\nPalestinian Territories, while continuing to provide full\nsupport for a two-state solution to the Israel/Palestine conflict.\nThey call on the GCC member states to contribute more to\nstrengthening Palestinian institutions and to economic development,\nwithin the context of the Palestinian Authority's government\nprogramme, and to consider paying their financial contributions\nthrough existing international aid mechanisms, where\nappropriate.
\nTrade relations:\nrecalling its resolution of 24 April 2008\non the Free Trade Agreement (FTA) between the EC and the GCC,\nParliament deplores the fact that negotiations between the EU and\nthe GCC (EU-GCC FTA) have suffered repeated lengthy delays. It also\ndeplores the GCC's decision to suspend these negotiations in 2008.\nIt believes that it is high time to unblock these negotiations\nso that a definitive solution can be found. After 20 years of\nnegotiations, the FTA has still to be concluded despite the fact\nthat it should be seen not only as an instrument to enhance welfare\nthrough trade, but also as a tool to foster geopolitical\nstability.
\nIn particular, Parliament calls for:
\nMembers reaffirm that the EU's primary objective in\nits relations with the GCC should be to conclude the FTA, which\nwill be a major region-to-region agreement. They encourage the High\nRepresentative/Vice-President and the Commissioner for Trade to\nassess alternative approaches to future commercial relations with\nthe GCC member states, in the form of bilateral agreements between\nthe EU and the Gulf States that already feel prepared to enter into\nfurther commitments with the EU. They also believe that an\nFTA with the EU would facilitate the further economic\nintegration of the GCC and that, following the establishment of\nthe GCC Customs Union, it may also lend greater impetus to\nimportant projects such as the GCC common market and the completion\nof a GCC monetary union with a single currency.
\nParliament states that the future FTA should\nalso:
\nMembers propose the establishment of a regular\nheads of state and government summit between the EU and the GCC\nwhich could enhance the political, financial, economic, commercial\nand cultural ties between the EU and GCC immensely.
\nMigrant workers: the\nresolution notes that there are 15 million migrant workers in the\nsix Gulf Cooperation Council states and that those workers make up\n40% of the total population. Members recall the precarious\nsituation of migrant workers in the Gulf States which was\nhighlighted by the International Labour Organisation (ILO) and\nsupports the ILO's call for a minimum wage in the region in order\nto prevent any further deterioration in the position of domestic\nand migrant workers.
\nEnergy: Parliament\nconsiders that synergies must be encouraged on the issue of\nrenewable energy. It commends the work carried out by the EU-GCC\nEnergy Expert Group, in particular on natural gas, energy\nefficiency and nuclear safety and calls on the Commission, in the\nlight of the challenge of climate change and the growing energy\nconsumption in both regions, to address energy efficiency as one of\nthe main areas of development and to enhance cooperation on energy\nefficiency issues. Members call for greater transparency in oil\nand gas data as regards the future demand and supply scenario,\nin keeping with the shared interest in predictable oil markets.\nThey recognise that the GCC's efforts to increase potential natural\ngas and liquid natural gas (LNG) reserves accord with the EU's\ndesire to diversify energy sources and supply routes. They\nencourage the GCC member states to coordinate the further\ndevelopment of gas-to-liquid (GTL) technology with their European\npartners in order better to incorporate GTL into the European\nenergy mix. Members also emphasise that the EU has opportunities to\ninvest in GCC energy production capacity, using the latest\ntechnologies in terms of generation, transmission and\ninterconnection.
\nThe resolution stresses the importance of a reliable\npartnership between the EU and the GCC in the use of, and access\nto, raw materials. It favours open markets for goods and the\nremoval of non-tariff barriers. It calls for joint efforts to\naddress the speculation and price volatility affecting raw\nmaterials, through greater transparency and closer supervision\nof OTC derivatives trading.
\nMembers also make a number of recommendations with a\nview to strengthening bilateral cooperation in the following\nfields:
\nLastly, Parliament recommends that the EU devote\nmore resources to the GCC via the instrument for cooperation\nwith industrialised and other high-income countries, which should\nbe made more visible and should focus on suitable programmes for\ntraining local civil servants, including in trade\nmatters.
\nThe Committee on Foreign Affairs adopted the\nown-initiative report drafted by Dominique BAUDIS (EPP, FR) on\nEuropean Union relations with the Gulf Cooperation Council\n(GCC).
\nFirstly, the report recalls\nthat its geopolitical environment makes the Gulf a focus of\nsecurity challenges that have global and regional implications (the\nMiddle East peace process, Iran's nuclear programme, the\nstabilisation of Iraq, Yemen and Darfur, terrorism and piracy). It\nstates that the GCC is still the only stable regional organisation\nbased on multilateralism and cooperation. In this context, Members\nemphasise that concluding the free trade agreement between the\nEU and the GCC remains a priority and that failure to conclude\nit would not be in either party's interests.
\nGiven the limited presence\nof the Union in the Gulf region, the EU needs to develop a strategy\nfor the region aimed at strengthening its ties with the GCC,\nsupporting the regional integration process, and encouraging\nbilateral relations with the GCC member states. The objective is a strategic partnership with\nthe GCC and its member states commensurate with the respective\nroles of the two entities on the international\nstage.
\nMembers call for the\nEuropean External Action Service (EEAS) to devote more human\nresources to the region and for new EU diplomatic missions to be\nopened in the GCC member states. They stress that these resources\nshould stem principally from a reallocation of staff within the\nEEAS. They also stress that tailored bilateral approaches to GCC\nmember states minded to engage in closer cooperation with the EU\ncan only complement and strengthen the multilateral\nframework.
\nMembers encourage all these\nstates to sustain their efforts and to do more to promote human\nrights, to combat discrimination of all kinds, including\ndiscrimination based on gender, sexual orientation and religion.\nThey invite the GCC member states to safeguard and promote the\nrights of minorities - including religious minorities - gender\nequality, the right to work - including for migrant workers - and\nfreedom of conscience, expression and opinion. A continuous\ndialogue on these issues is called for with the aim to:
\nIn parallel, obstacles to\nthe full and effective exercise of the fundamental right of\nreligious freedom should be removed. Members also reinstate the\nEU's opposition to the death penalty and Parliament's call\nfor a global moratorium on it.
\nJoint Action\nProgramme: Members note the\nthree-year Joint Action Programme adopted by the EU-GCC Joint\nCouncil and Ministerial Meeting on 14 June 2010 which is intended\nto strengthen cooperation in many strategic areas of mutual\ninterest. They consider that the implementation of this Joint\nAction Programme should be accompanied by a precise and detailed\nfunding scheme. They stress the importance of ensuring the\nvisibility of this programme and that an evaluation of the results\nshould be carried. Members call on the EU to focus its cooperation\nprogrammes with the GCC member states more on civil society\norganisations and to support the empowerment of women and\nyouth.
\nMiddle-East: Members\nexpress their profound concern at seeing the Gulf region caught up\nin an arms race and ask the EU to initiate a strategic dialogue\nwith the GCC member states on regional security issues of common\ninterest (the Middle East peace process, Iran's nuclear programme,\nthe stabilisation of Iraq, Yemen and Darfur, terrorism and piracy).\nThey call for a regional security structure in the Middle\nEast to be built in partnership with the Gulf states. The\nreport emphasises that it is in the common interest of the EU and\nthe GCC to promote peace and stability in the Middle East, North\nAfrica and the Horn of Africa, and globally. It urges the partners\nto strengthen cooperation on this matter of common\ninterest.
\nMembers reiterate their\nsupport for the Arab peace initiative put forward by one of the GCC\nmember states and call on the GCC member states to continue their\nmediation efforts and support for the Israeli-Palestinian peace\nprocess. They call on the EU and the GCC to step up joint efforts\nto bring about a negotiated end to the occupation of the\nPalestinian Territories, while continuing to provide full\nsupport for a two-state solution to the Israel/Palestine conflict.\nMembers call on the GCC member states to contribute more to\nstrengthening Palestinian institutions and to economic development,\nwithin the context of the Palestinian Authority's government\nprogramme, and to consider paying their financial contributions\nthrough existing international aid mechanisms, where\nappropriate.
\nTrade\nrelations: recalling its resolution\nof 24 April 2008 on the Free Trade Agreement (FTA) between the EC\nand the GCC, Members deplore the fact that negotiations between the\nEU and the GCC (EU-GCC FTA) have suffered repeated lengthy delays.\nThey also deplore the GCC's decision to suspend these negotiations\nin 2008. They believe that it is high time to unblock\nthese negotiations so that a definitive solution can be found.\nAfter 20 years of negotiations, the FTA has still to be concluded\ndespite the fact that it should be seen not only as an instrument\nto enhance welfare through trade, but also as a tool to foster\ngeopolitical stability.
\nIn particular, Members call\nfor:
\nMembers reaffirm that the EU's primary objective in its\nrelations with the GCC should be to conclude the FTA, which\nwill be a major region-to-region agreement. They encourage the High\nRepresentative/Vice-President and the Commissioner for Trade to\nassess alternative approaches to future commercial relations with\nthe GCC member states, in the form of bilateral agreements between\nthe EU and the Gulf States that already feel prepared to enter into\nfurther commitments with the EU. They also believe that an\nFTA with the EU would facilitate the further economic\nintegration of the GCC and that, following the establishment of\nthe GCC Customs Union, it may also lend greater impetus to\nimportant projects such as the GCC common market and the completion\nof a GCC monetary union with a single currency.
\nMembers states that the\nfuture FTA should also:
\nMembers propose the\nestablishment of a regular heads of state and government summit\nbetween the EU and the GCC which could enhance the political,\nfinancial, economic, commercial and cultural ties between the EU\nand GCC immensely.
\nMigrant\nworkers: the report notes that there\nare 15 million migrant workers in the six Gulf Cooperation Council\nstates and that those workers make up 40% of the total population.\nMembers recall the precarious situation of migrant workers in the\nGulf States which was highlighted by the International Labour\nOrganisation (ILO) and supports the ILO's call for a minimum wage\nin the region in order to prevent any further deterioration in the\nposition of domestic and migrant workers.
\nEnergy: Members consider that synergies must be encouraged\non the issue of renewable energy. They commend the work\ncarried out by the EU-GCC Energy Expert Group, in particular on\nnatural gas, energy efficiency and nuclear safety and call on the\nCommission, in the light of the challenge of climate change and the\ngrowing energy consumption in both regions, to address energy\nefficiency as one of the main areas of development and to enhance\ncooperation on energy efficiency issues. They\ncall for greater transparency in oil and gas data as regards\nthe future demand and supply scenario, in keeping with the shared\ninterest in predictable oil markets. They recognise that the GCC's\nefforts to increase potential natural gas and liquid natural gas\n(LNG) reserves accord with the EU's desire to diversify energy\nsources and supply routes. They encourage the GCC member states to\ncoordinate the further development of gas-to-liquid (GTL)\ntechnology with their European partners in order better to\nincorporate GTL into the European energy mix. Members also\nemphasise that the EU has opportunities to invest in GCC energy\nproduction capacity, using the latest technologies in terms of\ngeneration, transmission and interconnection.
\nThe report stresses the\nimportance of a reliable partnership between the EU and the GCC in\nthe use of, and access to, raw materials. It favours open markets\nfor goods and the removal of non-tariff barriers. It calls for\njoint efforts to address the speculation and price volatility\naffecting raw materials, through greater transparency and\ncloser supervision of OTC derivatives trading.
\nMembers also make a number\nof recommendations with a view to strengthening bilateral\ncooperation in the following fields:
\nLastly, Members recommend\nthat the EU devote more resources to the GCC via the\ninstrument for cooperation with industrialised and other\nhigh-income countries, which should be made more visible and should\nfocus on suitable programmes for training local civil servants,\nincluding in trade matters.
\nThe European Parliament adopted a resolution on\nEuropean Union relations with the Gulf Cooperation Council\n(GCC).
\nParliament recalls that its geopolitical environment\nmakes the Gulf a focus of security challenges that have global and\nregional implications (the Middle East peace process, Iran's\nnuclear programme, the stabilisation of Iraq, Yemen and Darfur,\nterrorism and piracy). It states that the GCC is still the only\nstable regional organisation based on multilateralism and\ncooperation. In this context, Members emphasise that concluding\nthe free trade agreement between the EU and the GCC remains a\npriority and that failure to conclude it would not be in either\nparty's interests.
\nGiven the limited presence of the Union in the Gulf\nregion, the EU needs to develop a strategy for the region aimed at\nstrengthening its ties with the GCC, supporting the regional\nintegration process, and encouraging bilateral relations with the\nGCC member states. The objective is a\nstrategic partnership with the GCC and its member states\ncommensurate with the respective roles of the two entities on the\ninternational stage.
\nParliament calls for the European External Action\nService (EEAS) to devote more human resources to the region and for\nnew EU diplomatic missions to be opened in the GCC member states.\nIt stresses that these resources should stem principally from a\nreallocation of staff within the EEAS. It also stresses that\ntailored bilateral approaches to GCC member states minded to engage\nin closer cooperation with the EU can only complement and\nstrengthen the multilateral framework.
\nMembers encourage all these states to sustain their\nefforts and to do more to promote human rights, to combat\ndiscrimination of all kinds, including discrimination based on\ngender, sexual orientation and religion. They invite the GCC member\nstates to safeguard and promote the rights of minorities -\nincluding religious minorities - gender equality, the right to work\n- including for migrant workers - and freedom of conscience,\nexpression and opinion. A continuous dialogue on these issues is\ncalled for with the aim to:
\nIn parallel, obstacles to the full and effective\nexercise of the fundamental right of religious freedom should be\nremoved. Members also reinstate the EU's opposition to the death\npenalty and Parliament's call for a global moratorium on\nit.
\nIn a series of oral amendments proposed by the\nRapporteur and adopted in Plenary, Parliament draws attention to\nthe social and political developments that have taken place in\nrecent years in most GCC member states. They take note of the fact\nthat demonstrators have expressed legitimate democratic\naspirations in several GCC States. The resolution recalls that\nthe violent reaction by the authorities to protests in Bahrain\nresulted in deaths, injuries, and imprisonments. Saudi, UAE and\nKuwaiti troops have arrived in the country under the banner of the\nGCC to participate in the repression of demonstrators. Plenary\ncalls on all Member States in the Gulf Cooperation Council to\nrecognise a continuing popular movement for democratic\nreform within the wider region, and calls for the full\nengagement with emerging civil society groups to promote a process\nof genuine peaceful democratic transition, within their own\ncountries, with partners in the region and with the full support of\nthe European Union.
\nAs regards Bahrain, Parliament expresses its deep\nconcern at the violent response of and the use of force against\nprotesters by Bahraini authorities and at the participation of\nforeign troops under the GCC banner in the repression of\ndemonstrators. This stands in stark contrast to the GCC's support\nfor the protection of the citizens demanding freedom and democracy\nin Libya. Parliament calls for an immediate end to violence against\npeaceful protesters and for a political dialogue that can lead to\nfurther necessary political reforms in the country.
\nJoint Action Programme:\nParliament notes the three-year Joint Action Programme adopted by\nthe EU-GCC Joint Council and Ministerial Meeting on 14 June 2010\nwhich is intended to strengthen cooperation in many strategic areas\nof mutual interest. It considers that the implementation of this\nJoint Action Programme should be accompanied by a precise and\ndetailed funding scheme. It stresses the importance of ensuring the\nvisibility of this programme and that an evaluation of the results\nshould be carried. Members call on the EU to focus its cooperation\nprogrammes with the GCC member states more on civil society\norganisations and to support the empowerment of women and\nyouth.
\nMiddle-East: Parliament\nexpresses its profound concern at seeing the Gulf region caught up\nin an arms race and asks the EU to initiate a strategic dialogue\nwith the GCC member states on regional security issues of common\ninterest (the Middle East peace process, Iran's nuclear programme,\nthe stabilisation of Iraq, Yemen and Darfur, terrorism and piracy).\nParliament calls for a regional security structure in the Middle\nEast to be built in partnership with the Gulf states. The\nresolution emphasises that it is in the common interest of the EU\nand the GCC to promote peace and stability in the Middle East,\nNorth Africa and the Horn of Africa, and globally. It urges the\npartners to strengthen cooperation on this matter of common\ninterest. At the same time, Plenary adopted an oral amendment in\nwhich Parliament takes note of the declaration by the GCC of 7\nMarch 2011 in Abu Dhabi, which states that 'the Ministerial council\ndemands that the Security Council takes the steps necessary to\nprotect civilians, including a no-fly zone in Libya', which\ndeclaration has contributed to the decision of the Arab League and\nthen the United Nations Security Council to pronounce themselves in\nfavour of such a zone.
\nIn parallel, Parliament reiterates its support for the\nArab peace initiative put forward by one of the GCC member states\nand calls on the GCC member states to continue their mediation\nefforts and support for the Israeli-Palestinian peace\nprocess.
\nMembers call on the EU and the GCC to step up joint\nefforts to bring about a negotiated end to the occupation of the\nPalestinian Territories, while continuing to provide full\nsupport for a two-state solution to the Israel/Palestine conflict.\nThey call on the GCC member states to contribute more to\nstrengthening Palestinian institutions and to economic development,\nwithin the context of the Palestinian Authority's government\nprogramme, and to consider paying their financial contributions\nthrough existing international aid mechanisms, where\nappropriate.
\nTrade relations:\nrecalling its resolution of 24 April 2008\non the Free Trade Agreement (FTA) between the EC and the GCC,\nParliament deplores the fact that negotiations between the EU and\nthe GCC (EU-GCC FTA) have suffered repeated lengthy delays. It also\ndeplores the GCC's decision to suspend these negotiations in 2008.\nIt believes that it is high time to unblock these negotiations\nso that a definitive solution can be found. After 20 years of\nnegotiations, the FTA has still to be concluded despite the fact\nthat it should be seen not only as an instrument to enhance welfare\nthrough trade, but also as a tool to foster geopolitical\nstability.
\nIn particular, Parliament calls for:
\nMembers reaffirm that the EU's primary objective in\nits relations with the GCC should be to conclude the FTA, which\nwill be a major region-to-region agreement. They encourage the High\nRepresentative/Vice-President and the Commissioner for Trade to\nassess alternative approaches to future commercial relations with\nthe GCC member states, in the form of bilateral agreements between\nthe EU and the Gulf States that already feel prepared to enter into\nfurther commitments with the EU. They also believe that an\nFTA with the EU would facilitate the further economic\nintegration of the GCC and that, following the establishment of\nthe GCC Customs Union, it may also lend greater impetus to\nimportant projects such as the GCC common market and the completion\nof a GCC monetary union with a single currency.
\nParliament states that the future FTA should\nalso:
\nMembers propose the establishment of a regular\nheads of state and government summit between the EU and the GCC\nwhich could enhance the political, financial, economic, commercial\nand cultural ties between the EU and GCC immensely.
\nMigrant workers: the\nresolution notes that there are 15 million migrant workers in the\nsix Gulf Cooperation Council states and that those workers make up\n40% of the total population. Members recall the precarious\nsituation of migrant workers in the Gulf States which was\nhighlighted by the International Labour Organisation (ILO) and\nsupports the ILO's call for a minimum wage in the region in order\nto prevent any further deterioration in the position of domestic\nand migrant workers.
\nEnergy: Parliament\nconsiders that synergies must be encouraged on the issue of\nrenewable energy. It commends the work carried out by the EU-GCC\nEnergy Expert Group, in particular on natural gas, energy\nefficiency and nuclear safety and calls on the Commission, in the\nlight of the challenge of climate change and the growing energy\nconsumption in both regions, to address energy efficiency as one of\nthe main areas of development and to enhance cooperation on energy\nefficiency issues. Members call for greater transparency in oil\nand gas data as regards the future demand and supply scenario,\nin keeping with the shared interest in predictable oil markets.\nThey recognise that the GCC's efforts to increase potential natural\ngas and liquid natural gas (LNG) reserves accord with the EU's\ndesire to diversify energy sources and supply routes. They\nencourage the GCC member states to coordinate the further\ndevelopment of gas-to-liquid (GTL) technology with their European\npartners in order better to incorporate GTL into the European\nenergy mix. Members also emphasise that the EU has opportunities to\ninvest in GCC energy production capacity, using the latest\ntechnologies in terms of generation, transmission and\ninterconnection.
\nThe resolution stresses the importance of a reliable\npartnership between the EU and the GCC in the use of, and access\nto, raw materials. It favours open markets for goods and the\nremoval of non-tariff barriers. It calls for joint efforts to\naddress the speculation and price volatility affecting raw\nmaterials, through greater transparency and closer supervision\nof OTC derivatives trading.
\nMembers also make a number of recommendations with a\nview to strengthening bilateral cooperation in the following\nfields:
\nLastly, Parliament recommends that the EU devote\nmore resources to the GCC via the instrument for cooperation\nwith industrialised and other high-income countries, which should\nbe made more visible and should focus on suitable programmes for\ntraining local civil servants, including in trade\nmatters.
\nPURPOSE: Communication presenting a new political\nframework for tourism in Europe.
\nCONTENT: tourism is an economic activity capable of\ngenerating growth and employment in the EU. With some 1.8 million\nbusinesses, primarily SMEs, employing approximately 5.2 % of the\ntotal workforce, the European tourism industrygenerates over 5 % of EU GDP, a figure which is\nsteadily rising.Tourism therefore\nrepresents the third largest socioeconomic activity in the EU after\nthe trade and distribution and construction sectors. Taking into\naccount the sectors linked to it,tourism's contribution to GDP is even greater; it is\nestimated to generate over 10 % of the EU's GDP and provide\napproximately 12 % of all jobs. In this regard, observing the trend\nover the last ten years, growth in employment in the tourism sector\nhas almost always been more pronounced than in the rest of the\neconomy. In addition, the EU remains the world's favourite tourist\ndestination, with 370 million international tourist arrivals in\n2008, or 40 % of arrivals around the world.
\nHowever, European tourism has faced difficult times.\nFirstly, the economic and financial crisis affecting all economies\nsince 2008 has had a considerable effect on demand for tourism\nservices. Tourist activity in Europe fell by approximately 5.6 % in\n2009. The difficulties have been aggravated by the eruption of the\nEyjafjöll volcano. The interruption of air traffic during\nApril and May 2010 due to the presence of volcanic ash clouds had a\nmajor effect on travel in Europe, causing significant disruption to\nairlines, travel agencies and tour operators as well as tourists\nthemselves.
\nThis difficult background for the tourism industry has\nhighlighted a number of challenges which the European tourism\nsector must face. It is essential that all operators in the sector\ncombine their efforts and work within a consolidated political\nframework that takes account of the new EU priorities set out in\nthe 'Europe 2020' strategy: Europe must remain the world's No 1\ndestination, able to capitalise on its territorial wealth and\ndiversity.
\nWith this Communication, the Commission intends to\nencourage a coordinated approach for initiatives linked to\ntourism and define a new framework for action to increase its\ncompetitiveness and its capacity for sustainable growth. It\ntherefore proposes a number of European or multinational\ninitiatives aimed at achieving these objectives, drawing in full on\nthe Union's competence in the field of tourism as introduced by the\nLisbon Treaty.
\nThe actions planned are as follows:
\n