2011/0421(COD)

Serious cross-border threats to health

Awaiting Parliament 1st reading / single reading / budget 1st stage

General
Activities
Documents
Amendments (90)
History

2011/0421(COD) Serious cross-border threats to health
Next event: Indicative plenary sitting date, 1st reading/single reading 2013/09/10

Role	Committee	Rapporteur	Shadows
Lead	ENVI	PARGNEAUX Gilles (S&D)	FJELLNER Christofer (EPP), BREPOELS Frieda (Verts/ALE), CABRNOCH Milan (ECR), MAŠTÁLKA Jiří (GUE/NGL), CYMAŃSKI Tadeusz (EFD)
Opinion	IMCO

Lead committee dossier: ENVI/7/08163
Legal Basis TFEU TFEU 168-p4, TFEU TFEU 168-p5

Subjects

Links

Activites

2013/09/10 Indicative plenary sitting date, 1st reading/single reading
#3206
2012/12/06 Council Meeting
2012/10/17 Committee report tabled for plenary, 1st reading/single reading
- A7-0337/2012 summary
  
  The Committee on the Environment, Public Health and Food Safety adopted the report by Gilles PARGNEAUX (S&D, FR) on the proposal for a decision of the European Parliament and of the Council on serious cross-border threats to health. The committee recommends that the European Parliaments position adopted at first reading, under the ordinary legislative procedure, should amend the Commission proposal as follows: Subject matter: Members consider that this Decision should define the roles, duties and responsibilities of the key actors and structures at Union level, as well as the methods of cooperation and coordination envisaged between the various institutions. This Decision shall apply in case of threats of biological origin, consisting of communicable diseases, including human zoonotic infections. Preparedness and response planning: Member States shall, in liaison with the Commission and on the basis of its recommendations, within the Health Security Committee, address the following issues: (i) the adoption of guidance and other awareness materials on the health and hygiene measures that the public must follow in the event of serious cross-border threats to health; (ii) the communication of best practices. Members also stress that information on communicable disease monitoring and vaccination coverage as set out in Decision 2119/98/EC on epidemiological surveillance will be essential to Commission led preparedness and response planning. Recalling that according to the World Health Organisation, more than 60% of human infections are zoonoses originating in animals or animal products, the report highlights that an holistic approach needs to be taken, with coordination and close cooperation between the human health and veterinary sectors being a crucial component of this. The Health Security Committee shall advise the health ministers of the Member States and the Commission on the preparation and coordination of contingency plans. Communication strategy: Members consider that this decision should further stress the importance of implementing a consistent and coordinated communication strategy should a crisis arise. They propose introducing a specific article stipulating that the actors in the Early Warning and Response System shall develop their communication strategy in line with the case in hand in order to keep citizens informed of the risk and the measures taken. That communication strategy shall stipulate the content of the message and the time of communication about the problem in question, including the most suitable arrangements for distribution. Risk assessment and common public health measures: public health risk assessment should also be based on the opinion of the WHO in the case of an international public health emergency. The common temporary measures adopted should be consistent with the recommendations established by the World Health Organisation in the case of an international public health emergency. When adopting common temporary public health measures, the Commission must specify the reasons for adopting these measures. Recognition of emergency situations: Members state that the term emergency situations should cover everything. There is no need to specify pandemic influenza situations separately. National authorities and representatives: as there are various Member States where responsibility for public health is not an exclusively national matter, but is substantially decentralised, Members consider it crucial to guarantee that national authorities involve the relevant decision-making authorities in the implementation of this decision in the Member States. They stress that the public nature of the appointment of structures or authorities which are part of the Community network should be emphasised. Measures as regards the confidentiality of personal data should be strengthened. Political dialogue: Members state that regular dialogue should be established between the Commission and the European Parliament so that the latter may be informed of the activities and the proper functioning of the Early Warning and Response System. In the case of a health warning, the Commission must, within the two months following the adoption of measures, submit a detailed report to the European Parliament and the Council on the content of these measures and their contribution to reducing the serious cross-border threat to health.
- ENVI ENVI/7/08163 PARGNEAUX Gilles S&D
- IMCO
2012/10/10 Vote in committee, 1st reading/single reading
- ENVI ENVI/7/08163 PARGNEAUX Gilles S&D
- IMCO
2012/10/09 Amendments tabled in committee
- PE496.640
2012/09/18 Amendments tabled in committee
- PE496.383
#3177
2012/06/21 Council Meeting
2012/06/20 Committee draft report
- PE491.305
2012/03/28 Economic and Social Committee: opinion, report
- CES0827/2012
2012/03/28 Document attached to the procedure
- N7-0082/2012 summary
  
  Opinion of the European Data Protection Supervisor on the proposal for a decision of the European Parliament and of the Council on serious cross-border threats to health The Proposal aims at replacing Decision 2119/98/EC setting up a network for the epidemiological surveillance and control of communicable diseases in the Community, which is the current legal basis for the Early Warning and Response System (EWRS). The latter has been the subject of a prior check Opinion of the EDPS. The EDPS welcomes the references to Regulation (EC) No 45/2001 and Directive 95/46/EC in Article 18 of the proposal and the fact that the reference to the applicable data protection legislation inArticle 18 now encompasses all personal data processing under the scope of the proposal. He also welcomes the specific data protection safeguards for contact tracing set forth, or required to be adopted by the Commission, under Article 18. However, the following elements of the Proposal still require, or would benefit from, clarification, further detail or other improvements from the point of view of data protection: · contact tracing, · ad hoc surveillance, · controller-processor relationship, · retention period, and · security measures. The EDPS notes that several aspects of the proposal are not elaborated in the text itself, but will be the subject of delegated and implementing acts, such as the list of communicable diseases to which the proposal shall apply and the procedures for the information exchange in the EWRS. Other aspects will be clarified in guidelines and recommendations to be adopted by the Commission, such as the data protection guidelines for the EWRS. Whilst details can of course be regulated in delegated and implementing acts, and such additional provisions are certainly of great benefit, the EDPS recommends that the proposal itself also provide more guidance on some of the points mentioned above. Recommendations: in general, the EDPS recommends that some essential elements, including certain essential data protection safeguards, should be also included in the text of the proposal itself. In addition, some clarifications are also necessary due to the expansion of the scope of the proposal to additional health threats beyond communicable diseases, which have not been subject to the prior checking procedure and also not discussed in the guidelines. More particularly, the EDPS recommends that the Proposal should: provide a clearer definition for contact tracing, including also its purposes and scope, which might be different for communicable diseases and other heath threats; define more clearly how the individuals used for contact tracing will be determined, which sources might be used to obtain contact details and how these individuals will be informed of the processing of their personal data; include criteria to be used when assessing whether contact tracing measures are necessary and proportionate; specify at least the main categories of data to be processed for contact tracing; for the system of ad hoc surveillance, specify the kinds of data to be processed and take measures to minimise the processing of personal data, for example by using appropriate anonymisation techniques and restricting the processing to aggregate data as far as possible; clarify the relationship between ad hoc surveillance networks and the EWRS; clarify the role of the ECDC in ad hoc surveillance networks; clarify the tasks and responsibilities of all actors involved from the data protection point of view in order to obtain legal certainty on the issue of controllership; establish legally binding retention periods at least for contact tracing; include in Article 18 a more specific reference to the requirements on data security and confidentiality.
- OJ C 197 05.07.2012, p. 0021
- DG {u'url': u'http://ec.europa.eu/dgs/health_consumer/index_en.htm', u'title': u'Health and Consumers'}, BORG Tonio
2012/01/17 Committee referral announced in Parliament, 1st reading/single reading
- ENVI ENVI/7/08163 PARGNEAUX Gilles S&D
- IMCO
2011/12/08 Legislative proposal
- COM(2011)0866 summary
  
  PURPOSE: establish a European initiative to combat serious cross-border threats to health. PROPOSED ACT: Decision of the European Parliament and of the Council. BACKGROUND: many activities related to preparedness and response planning and risk assessment for communicable diseases but also for chemical threats to health and events caused by climate change have been supported at European level, in particular the current Community network for the epidemiological surveillance and control of communicable diseases (see Decision No 2119/98/EC of the European Parliament and the Council establishing a network for the epidemiological surveillance and control of communicable diseases in the Community). The EU already has policies, mechanisms and instruments in place for the prevention and control of serious cross-border threats and for the development of capacities to manage crises. A non-exhaustive list includes the EU Civil Protection Mechanism, the Cohesion and Solidarity Funds, the EU action plan on chemical, biological, radiological and nuclear security, and European alert networks, such as ECURIE. In order to avoid overlaps with these areas and duplicating existing disaster prevention and control structures, a gap analysis has been carried out to assess how far these existing systems cover the monitoring of threats to health, their notification, risk assessment and crisis management capacities and structures from the public health perspective. This gap analysis revealed that the existing structures and mechanisms at EU level do not address these threats sufficiently as far as public health is concerned. The lack of public health risk assessment at EU level leads to discrepancies in evaluating the danger of a given threat, duplication of assessments between Member States and inconsistent measures at EU level. Such a situation can also lead to inefficient use of the limited resources currently available. Although the Member States have the responsibility to manage public health crises at national level, no country can tackle a cross border public health crisis on its own. At EU level, the legal basis for addressing serious cross-border health threats has been reinforced with the Lisbon Treaty. The EU can now take action in this field that complement and support national policies and encourage cooperation between Member States. This is the reason why it is proposed to create a new instrument to step up cooperation and strengthen coordination in the area of the notification and risk assessment. The aim is to streamline and strengthen European Union capacities and structures for effectively responding to serious cross-border health threats. These threats can be events caused by communicable diseases, biological agents responsible for non-communicable diseases, and threats of chemical, environmental, or unknown origin, as well as threats deriving from the effects of climate change. IMPACT ASSESSMENT: The Commission has carried out detailed analysis of three options: Option 1: status quo: maintaining the current level of activities; Option 2: separate and different handling of serious cross-border threats to health - enhanced EU cooperation through the use of soft instruments based on a voluntary approach; Option 3: establishing a common EU legal framework covering all serious cross-border threats to health through improved cooperation and legally binding measures. The results of the analysis led to the conclusion that option 3 has the strongest positive health impacts as it improves the protection of citizens against serious cross-border threats to health. LEGAL BASIS: Article 168, paragraphs (4)(c) and (5) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: this proposal lays down the rules on monitoring, early warning of and combating serious cross-border threats to health, as well as on preparedness and response planning related to those activities. It aims to support the prevention and control of the spread of severe human diseases across the borders of the Member States, and to obviate other major sources of serious cross-border threat to health in order to contribute to a high level of public health protection in the Union. Scope: the proposal applies in case of serious cross-border threats to health falling within the following categories: threats of biological origin, consisting of: (i) communicable diseases; (ii) antimicrobial resistance and healthcare-associated infections related to communicable diseases; (iii) biotoxins or other toxic biological agents not related to communicable diseases; threats of chemical origin with the exception of threats arising from ionizing radiation; threats of environmental origin, including threats deriving from the effects of climate change; threats of unknown origin; events which may constitute public health emergencies of international concern determined pursuant to the International Health Regulations (2005). General structure: the monitoring system revolves around the following four fields: 1) preparedness and response planning: the proposal provides for the coordination of the efforts of the Member States in terms of improved preparedness and capacity building. To this end, the Commission will ensure coordination between national planning and between key sectors such as transport, energy and civil protection, and will support Member States in setting up a joint procurement mechanism for medical countermeasures, e.g. vaccines against influenza, which would enable the EU to be better prepared for future pandemics; 2) establishment of an epidemiological monitoring network: to provide the relevant information and data for risk assessment and monitoring of emerging threats, an ad hoc network will be set up in situations where a Member State has raised an alert on a serious threat other than a communicable disease. Communicable diseases will continue to be monitored as they are today; 3) the use of the existing Early Warning and Response System to cover all serious threats to health, and not only communicable diseases as is the case today; 4) coordinated development of national or European public health risk assessments for threats of biological, chemical, environmental or unknown origin in a crisis situation. EU response to a public health crisis: the proposal sets up a coherent framework for the EU response to a public health crisis. In concrete terms, by formalising the existing Health Security Committee, the EU will be in a better position to coordinate national crisis responses in a public health emergency. A procedure for the mobilisation and coordination of the European response to a serious cross-border risk is proposed. Thus, if a Member State intends to adopt public health measures to combat a serious cross-border health risk, it shall, before adopting any measures consult the other Member States and the Commission on the nature, purpose and scope of the measures. The measures taken shall be decided by means of implementing acts. Provision is also made for the following specific measures: Common temporary public health measures to control the spread of a serious cross-border threat to health between the Member States or to the Union as a whole; Emergency and pandemic influenza situations at the Union level; International agreements with third countries or international organisations. BUDGETARY IMPACT: this legal proposal does not impact on decentralised agencies. In addition, the current EU health programme already covers some activities in relation to monitoring, alerting and risk assessment of some health threats. After 2013, the Commission intends to cover these activities under the proposed Health for growth programme 2014-2020. The cost is included in the proposed envelope of the new programme. DELEGATED ACTS: in accordance with Article 290 of the TFEU, the Commission should be empowered to adopt delegated acts in respect of measures needed to complement the action of the Member States, in very specific and urgent situations, for the transnational aspects of the control of serious cross-border threats to health. In order to ensure uniform conditions for the implementation of this Decision, implementing powers should be conferred on the Commission to adopt implementing acts in relation to: the procedures for the coordination, the exchange of information and the mutual consultation on preparedness and response planning; the adoption of a list of communicable diseases subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the setting up and termination of ad hoc monitoring networks and the procedures for the operation of such networks; the adoption of case definitions for serious cross-border threats to health; the procedures for the operation of the Early Warning and Response System; the procedures for the coordination of the responses of the Member States; the recognition of situations of emergency at Union level or of pre-pandemic situations with respect to human influenza at Union level.
- SEC(2011)1519
- SEC(2011)1520
- DG {u'url': u'http://ec.europa.eu/dgs/health_consumer/index_en.htm', u'title': u'Health and Consumers'}, BORG Tonio

Documents

Legislative proposal published: COM(2011)0866
Document attached to the procedure: SEC(2011)1519
Document attached to the procedure: SEC(2011)1520
Economic and Social Committee: opinion, report: CES0827/2012
Document attached to the procedure: N7-0082/2012
Document attached to the procedure: OJ C 197 05.07.2012, p. 0021
Committee draft report: PE491.305
Amendments tabled in committee: PE496.383
Amendments tabled in committee: PE496.640
Committee report tabled for plenary, 1st reading/single reading: A7-0337/2012

Amendments	Dossier
90	2011/0421(COD) Serious cross-border threats to health 2012/09/10 ENVI 3 amendments... Amendment 1 # Proposal for a decision recital 10 (10) The European Parliament in its resolution of 8 March 2011 and the Council in its Conclusions of 13 September 2010 stressed the need to introduce a common procedure for the joint procurement of medical countermeasures, and in particular of pandemic vaccines, to allow Member States, on a voluntary basis, to benefit from such group purchases and to obtain advantageous prices and order flexibility with regard to a given product. With regard to pandemic vaccines, in the context of limited production capacities at global level, such a procedure ~~would increase the avail~~is undertaken with the aim of enabili~~ty of those products and ensure fairer access to them among M~~ng more equitable access to vaccines for the Member States involved, to help them be~~r States participating in the joint procurement~~tter meet the vaccination needs of their citizens, in line with vaccination policies in the Member States. Amendment 2 # Proposal for a decision Article 2 – paragraph 2 a (new) 2a. in exceptional emergency situations where an EU mechanism for the coordination of public health measures in case of serious cross-border threats to health other than those covered in Article 2(1) (ie threats of biological, chemical and environmental origin) proves insufficient to ensure a high level of human health protection, Member States may refer such threats for a coordinated response to the Health Security Committee in accordance with Article 11, in close coordination with other Union areas, as appropriate. Amendment 3 # Proposal for a decision Article 8-paragraph 1 bis (new) The actors in the Early Warning and Response System shall undertake to act independently in the public interest. Prior to taking up their duties, they shall make available a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be prejudicial to their independence. Those declarations shall be updated when significant changes occur, and at least once a year. The declarations shall be verified by the Commission for actors at Union level, and by the relevant competent authority for actors at Member State level. source: PE-496.640 2012/09/17 ENVI 87 amendments... Amendment 33 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Recital 1 (1) Article 168 of the Treaty on the Functioning of the European Union states, inter alia, that the Union's action in the field of public health should co~~ver~~mplement the work of the Member States with regard to monitoring, early warning of and combating serious cross-border threats to health, and that a high level of human health protection is to be ensured, inter alia, in the definition and implementation of all Union policies and activities. According to the same provision, Member States must, in liaison with the Commission, coordinate among themselves their policies and programmes in the areas covered by the Union action in the field of public health. Amendment 34 # Anna ROSBACH Proposal for a decision Recital 3 (3) Apart from communicable diseases, a number of other ~~sources of danger to health, notably related to other~~threats, of biological ~~agents~~, chemical ~~agents~~ or environmental ~~events, which include hazards related to climate change~~origin or arising from an increased prevalence of antimicrobial resistance or defective implantable medical devices, may, by reason of their scale or severity, endanger the health of citizens in the entire Union, lead to the malfunctioning of critical sectors of society and economy and jeopardise individual Member State's capacity to react. Therefore, the legal framework set up under Decision No 2119/98/EC should be extended to cover these other threats and provide for a coordinated wider approach to health security at Union level. Amendment 35 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Recital 3 (3) Apart from communicable diseases, a number of other sources of danger to health, notably related to other biological agents, chemical agents or environmental events, which include hazards related to climate change, may, by reason of their scale or severity, endanger the health of citizens in the entire Union, lead to the malfunctioning of critical sectors of society and economy and jeopardise individual Member State's capacity to react. Therefore, the legal framework set up under Decision No 2119/98/EC should be extended to cover these other threats and provide for a coordinated wider approach to health security at Union level. However, existing Union instruments concerned with early warning, monitoring and coordination must continue to be assigned priority where serious cross-border threats to health arise. Amendment 36 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Recital 5 (5) Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for Disease Prevention and Control (ECDC) provides the ECDC with a mandate covering surveillance, detection and risk assessment of threats to human health from communicable diseases and outbreaks of unknown origin, until their origin is known. The ECDC has progressively taken over the epidemiological surveillance of communicable diseases and the operation of the Early Warning and Response System from the Community network set up under Decision No 2119/98/EC. This development is not reflected in Decision No 2119/98/EC, which was adopted before the creation of the ECDC. Amendment 37 # Peter LIESE Proposal for a decision Recital 8 a (new) (8a) Cross-border threats to health are also often related to pathogenic agents that can be transmitted between individuals. While such transmission cannot be completely prevented, general hygiene measures can make an important contribution by reducing the speed and extent of spreading of the agent and thus reduce the general risk. Such good hygiene practices should be promoted, especially in sensitive environments and at the work place. Amendment 38 # Rebecca TAYLOR, Frédérique RIES Proposal for a decision Recital 10 (10) The European Parliament in its resolution of 8 March 2011 and the Council in its Conclusions of 13 September 2010 stressed the need to introduce a common procedure for the joint procurement of medical countermeasures, and in particular of pandemic vaccines, to allow Member States, on a voluntary basis, to benefit from such group purchases. With regard to pandemic vaccines, in the context of limited production capacities at global level, such a procedure ~~would increase the avail~~is undertaken with the aim of enabili~~ty of those products and ensure fairer access to them among Member States participating in the joint procurement~~ng more equitable access to vaccines for the Member States involved, to help them better meet the vaccination needs of their citizens, in line with national vaccination policies. Amendment 39 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Recital 11 (11) Contrary to communicable diseases, whose surveillance at the Union level is carried out on a permanent basis by the ECDC, other serious cross-border threats to health do not currently necessitate a systematic monitoring. A risk-based approach, whereby monitoring networks are set up ad hoc and on a temporary basis, is therefore more appropriate to those other threats.deleted Amendment 40 # Anna ROSBACH Proposal for a decision Recital 11 (11) Contrary to communicable diseases, whose surveillance at the Union level is carried out on a permanent basis by the ECDC, other serious cross-border threats to health, with perhaps the exception of antimicrobial resistance, do not currently necessitate a systematic monitoring. A risk-based approach, whereby monitoring networks are set up ad hoc and on a temporary basis, is therefore more appropriate to those other threats. Amendment 41 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Recital 12 (12) A system enabling the notification at the Union level of alerts related to serious cross-border threats to health should be put in place in order to ensure that competent public health authorities in Member States and the Commission are duly and timely informed. Therefore, an Early Warning and Information System should be established, bringing together the various information about serious cross-border health threats of a biological, chemical or environmental nature. This Early Warning and Information System should be integrated into the Early Warning and Response System (EWRS), established under Decision No 2119/98/EC for communicable diseases~~, should be extended~~ relating to all the serious cross-border threats to health covered by the present Decision. The notification of an alert should be required only where the scale and severity of the threat concerned are or may become so significant that the coordination of the response at the Union level is necessary. The responsibility and scope of the existing instruments should be preserved. Amendment 42 # Frieda BREPOELS Proposal for a decision Recital 13 (13) In order to ensure that the assessment of risks to public health at the Union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective, the available scientific expertise should be mobilised in a coordinated manner, through appropriate channels or structures depending on the type of threat concerned. This risk assessment should be based on robust scientific evidence and independent expertise and provided by the Agencies of the Union in accordance with their missions, or otherwise by expert groups set up by the Commission. When experts are consulted, they should make a declaration of commitment and a declaration of their interests. The Commission should verify these declarations. Amendment 43 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Recital 13 (13) In order to ensure that the assessment of risks to public health at the Union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective, the available scientific expertise should be mobilised in a coordinated manner, through appropriate channels or structures depending on the type of threat concerned. This risk assessment should be based on robust scientific evidence and independent expertise and provided by the Agencies of the Union in accordance with their missions, or otherwise by expert groups set up by the Commission and the Member States. Amendment 44 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Recital 14 (14) Effectively responding to serious cross-border threats to health at national level requires a consistent approach among Member States, in conjunction with the Commission, necessitating exchange of information, consultation and coordination of actions. Under Decision No 2119/98/EC, the Member States, in cooperation with the Commission, already coordinate the response at the Union level in collaboration with Member States with regard to communicable diseases. A similar mechanism should apply to all serious cross-border threats to health ~~independently of their origin~~. It should also be recalled that, independently from this Decision, a Member State may, in case of a major emergency, request assistance under Council Decision of 8 November 2007 establishing a Community Civil Protection Mechanism (2007/779/EC, Euratom). Amendment 45 # Rebecca TAYLOR, Frédérique RIES Proposal for a decision Recital 17 (17) The applicability of some specific provisions of Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council and Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products, depends on the recognition at Union level in the framework of Decision 2119/98/EC, of an emergency situation or of a pandemic situation with respect to human influenza. Those provisions allow for the accelerated marketing of certain medicinal products in case of urgent needs, by means, respectively, of a conditional marketing authorisation and of the temporary possibility to grant a variation to the terms of a marketing authorisation for a human influenza vaccine even where certain non- clinical or clinical data are missing. However, in spite of the utility of such provisions in the event of a crisis, there is to date no specific procedure for issuing such recognitions at Union level. It is therefore appropriate to provide for such a procedure as part of the standards of quality and safety for medicinal products. The declaration of an emergency situation at Union level should be without prejudice to the effects of a decision taken by the World Health Organisation to trigger the production of vaccines from seasonal to pandemic Amendment 46 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Recital 19 (19) Since the objectives of this Decision cannot be sufficiently achieved by the Member States alone due to the cross- border dimension of those threats and can, therefore, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union, to support the Member States. In accordance with the principle of proportionality, as set out in that Article, this Decision does not go beyond what is necessary in order to achieve those objectives. Amendment 47 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Recital 20 (20) The power to adopt delegated acts in accordance with the Article 290 of the Treaty on the functioning of the European Union should be conferred to the Commission in respect of measures needed to complement the action of the Member States, in very specific and urgent situations, for the transnational aspects of the control of serious cross- border threats to health. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, as far as the urgency of the situation allows it. The Commission, when preparing and drawing up delegated acts, should ensure simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.deleted Amendment 48 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Recital 21 (21) In order to ensure uniform conditions for the implementation of this Decision, implementing powers should be conferred on the Commission to adopt implementing acts in relation to: the procedures for the coordination, the exchange of information and the mutual consultation on preparedness and response planning; the adoption of a list of communicable diseases subject to the network of epidemiological surveillance and the procedures for the operation of such a network; ~~the setting up and termination of ad hoc monitoring networks and the procedures for the operation of such networks;~~ the adoption of case definitions for serious cross-border threats to health; the procedures for the operation of the Early Warning and ~~Response System; the procedures for the coordination of the responses of the Member Stat~~Information System; risk assessment procedures; the recognition of situations of emergency at Union level or of pre-pandemic situations with respect to human influenza at Union level. Those implementing powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers. Amendment 49 # Frieda BREPOELS Proposal for a decision Recital 22 a (new) (22a) As there are various Member States where responsibility for public health is not an exclusively national matter, but is substantially decentralised, it is crucial to guarantee that national authorities involve the relevant decision-making authorities in the implementation of this decision in the Member States. Amendment 50 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 2 – paragraph 1 – introductory part 1. This Decision shall apply in case of serious cross-border threats to public health falling within the following categories: Amendment 51 # Christel SCHALDEMOSE Proposal for a decision Article 2 – paragraph 1 – point a – point i (i) communicable diseases, including human zoonotic infections; Amendment 52 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 2 – paragraph 1 – point a – point ii (ii) antimicrobial resistance and healthcare- associated infections related to communicable diseases affecting human beings (hereinafter referred to as " the related special health issues") ; Amendment 53 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 2 – paragraph 1 – point b (b) acute threats of chemical origin with the exception of threats arising from ionizing radiation; Amendment 54 # Sari ESSAYAH Proposal for a decision Article 2 – paragraph 1 – point c (c) threats of environmental origin~~, including threats deriving from the effects of climate change~~; Amendment 55 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 2 – paragraph 1 – point c (c) acute threats of environmental origin, including threats deriving from the effects of climate change; Amendment 56 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 2 – paragraph 1 – point d (d) acute threats of unknown origin, until their origin is known and they fall into one of the categories described in points (a) to (c); Amendment 57 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 2 – paragraph 2 2. This Decision shall apply without prejudice to measures on monitoring, early warning of and combating serious cross-border threats to health as well as the requirements concerning preparedness and response planning provided for in other binding Union provisions, including measures setting standards of quality and safety for specific goods and measures concerning specific economic activities.deleted Amendment 58 # Christofer FJELLNER Proposal for a decision Article 2 – paragraph 2 a (new) 2a. In exceptional emergency situations where public health measures in case of serious cross-border threats to health other than those covered in Article 2(1) prove insufficient to ensure a high level of human health protection, Member States may refer such threats for coordination of response within the Health Security Committee in accordance with Article 11, in close coordination with other Union areas, as appropriate. Amendment 59 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 2 – paragraph 3 3. The Commission shall, where appropriate and in liaison with the Member States, ensure coordination and mutual information between the mechanisms and structures established under this Decision and similar mechanisms and structures established at Union level whose activities may be relevant for the monitoring, early warning and combating serious cross-border threats to health.deleted Amendment 60 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 2 a (new) Article 2a It is essential that the scope of the decision should be clearly limited in order to avoid duplication of effort with other Union instruments. Amendment 61 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 3 – paragraph 1 – point a (a) ‘case definition’ means a set of commonly agreed diagnostic criteria that must be fulfilled in order to accurately detect cases of a ~~target~~n identified serious cross- border threat to health in a given population, while excluding the detection of other similar threats; Amendment 62 # Christofer FJELLNER Proposal for a decision Article 3 – paragraph 1 – point b (b) ‘'communicable disease’' means an infectious disease caused by a contagious agent which may be transmitted from person to person by direct contact with an affected individual or by an indirect means such as exposure to a vector, fomite, animal, product or environment, or exchange of fluid, contaminated with the contagious agent; Amendment 63 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 3 – paragraph 1 a (new) The Commission, in cooperation with the Member States, should arrange for the coordination and exchange of information and the instruments created by this decision. It is the Commission’s task to prevent duplication of effort in the system: existing and new instruments should complement one another. Amendment 64 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 3 a (new) Article 3a Relationship with existing provisions of EU law 1. The provisions of this decision should not come into conflict with other existing EU instruments in the field of monitoring, early warning, coordination of preparations and contingency planning for serious cross-border threats to health. In this connection, existing instruments establishing standards and indicators for the quality and security of specific goods and indicators should be taken into account. Existing EU laws should therefore remain in force: a. Directive 2001/83/EC, b. Directive 2001/20/EC, c. Directive 2003/94/EC, d. Directive 2004/23/EC, e. Regulation 726/2004/EC, f. Regulation 1394/2007/EC, g. Regulation 540/95/EC, h. Regulation 178/2002/EC, i. Regulation 882/2004/EC j. Council Directive 96/82/EC. Amendment 65 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 4 – paragraph 1 – point b (b) the co~~nsistent implement~~ordination of core capacity requirements for surveillance and response as referred to in Articles 5 and 13 of the International Health Regulations (2005). Amendment 66 # Peter LIESE Proposal for a decision Article 4 – paragraph 1 – point b a (new) (ba) the adoption of guidance and other awareness materials on the health and hygiene measures that the public must follow in case of serious cross-border threats to health. These shall include information of good hygiene measures, such as effective hand washing and drying, in health care environments, food establishments, schools and nurseries, entertainment facilities, and also in the working environment, and shall take into account existing recommendations of the World Health Organization. Amendment 67 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 4 – paragraph 1 – point b a (new) (ba) the communication of ‘best practice’ plans. Amendment 68 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 4 – paragraph 2 – point i (i) minimum core capacity standards determined at national level for the health sector; these shall also relate to preparations in the field of psychosocial emergency care; Amendment 69 # Christel SCHALDEMOSE Proposal for a decision Article 4 – paragraph 2 – point ii (ii) specific mechanisms established at national level for the interoperability between the health sector, veterinary sector and other critical sectors of society; Amendment 70 # Rebecca TAYLOR, Frédérique RIES Proposal for a decision Article 4 – paragraph 2 – point iii a (new) (iiia) specific mechanisms to monitor and report on vaccines coverage in respect of those listed in the Annex to Decision 2119/98/EC. Amendment 71 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 4 – paragraph 4 ~~4. Before adopting or reviewing their national preparedness plan, Member States shall consult each other and the Commission in relation to the issues referred to in points (a) and (b) of paragraph 1.~~deleted Amendment 72 # Jiří MAŠTÁLKA Proposal for a decision Article 4 – paragraph 4 4. Before adopting or reviewing their national preparedness plan, Member States shall ~~consult~~inform each other and the Commission in relation to the issues referred to in points (a) and (b) of paragraph 1. Amendment 73 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 4 – paragraph 5 – subparagraph 1 ~~The Commission shall, by means of implementing acts, determine the procedures necessary for the coordination, the exchange of information and the mutual consultation referred to in paragraphs 1 to 4.~~deleted Amendment 74 # Christel SCHALDEMOSE Proposal for a decision Article 6 – paragraph 2 2. The epidemiological surveillance network shall bring into permanent communication the Commission, the European Centre for Disease Prevention and Control, the European Food Safety Authority and the competent authorities responsible at national level for collecting information relating to epidemiological surveillance. Amendment 75 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 7 – paragraph 1 1. Following an alert pursuant to Article 9 concerning a threat to health referred to in points (a)(iii), (b), (c) or (d) of Article 2(1), the Member States shall, on the basis of the available information from their monitoring systems, inform each other, in liaison with the Commission, through an ad hoc monitoring network set up pursuant to paragraph 3 as regards the developments of the situation related to the threat concerned at national level.deleted Amendment 76 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 7 – paragraph 2 2. The information transmitted pursuant to paragraph 1, shall include in particular any change in geographic distribution, spread and severity of the health threat concerned and of the means of detection. It shall be transmitted to the monitoring network by using, where applicable, the case definitions established in accordance with point (d) of paragraph 3.deleted Amendment 77 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 7 – paragraph 3 3. The Commission shall, by means of implementing acts: (a) set up, for the purposes of the cooperation referred to in paragraph 1, an ad hoc monitoring network which shall bring into communication the Commission and the national contact points designated by the Member States in accordance with point (b) of Article 17(1) for the threat concerned; (b) terminate the operation of an ad hoc monitoring network when the conditions for notifying an alert in relation to the threat concerned, as laid down in Article 9(1) are no longer met; (c) adopt generic procedures for the operation of ad hoc monitoring networks; (d) adopt, where necessary, the case definitions to be used for the ad hoc monitoring, in order to ensure at the Union level the comparability and compatibility of the collected data. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2). On duly justified imperative grounds of urgency related to the severity of a serious cross-border threat to health or to the rapidity of its spread between the Member States, the Commission may set up an ad hoc monitoring network or adopt or update the case definitions referred to in point (d) through immediately applicable implementing acts in accordance with the urgency procedure referred to in Article 20(3).deleted Amendment 78 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 8 – title Establishment of an early warning and ~~response~~information system Amendment 79 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 8 – paragraph 1 1. A rapid alert system for notifying at the Union level alerts in relation to serious cross-border threats to health, ‘Early Warning and ~~Response~~Information System’, is hereby established. This system shall bring into permanent communication the Commission and the competent authorities responsible at national level for alerting, assessing public health risks and determining the measures that may be required to protect public health. Amendment 80 # Rebecca TAYLOR, Frédérique RIES, Antonyia PARVANOVA Proposal for a decision Article 8 – paragraph 1 a (new) 1a. The actors in the Early Warning and Response System shall perform their duties independently and in the public interest. Prior to taking up their duties, they shall make available a declaration of interests, setting out any activities or roles which may compromise their integrity. Those declarations should be updated when significant changes occur, or at least once a year Amendment 81 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 8 – paragraph 2 The Commission shall, by means of implementing acts, adopt procedures concerning the information exchange in order to ensure the proper functioning of the Early Warning and ~~Response~~Information System and the uniform implementation of Articles 8 and 9. In order to be able to cover all kinds of serious cross-border threats to health, the information referred to in Article 3 must also be supplied. Amendment 82 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 8 a (new) Article 8a The Early Warning and Information System should be placed under the authority of the European Centre for Disease Prevention and Control. Amendment 83 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 9 – paragraph 1 – introductory part 1. National competent authorities or the Commission shall notify an alert in the Early Warning and ~~Response~~Information System where the emergence or development of a serious cross-border threat to health fulfils the following conditions: Amendment 84 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 9 – paragraph 3 – point h ~~(h) measures other than public health measures,~~deleted Amendment 85 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 9 – paragraph 4 4. The Commission shall make available to the national competent authorities through the Early Warning and ~~Response~~Information System any information that may be useful for coordinating the response at the Union level, including information on hazards and public health measures related to serious cross-border threats to health transmitted through other Union alert systems. Amendment 86 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 10 – paragraph 2 – point c ~~(c) where the assessment needed is totally or partially outside the mandates of the above-mentioned Agencies, on an ad hoc independent opinion.~~deleted Amendment 87 # Frieda BREPOELS Proposal for a decision Article 10 – paragraph 2 – point c (c) where the assessment needed is totally or partially outside the mandates of the above-mentioned Agencies, on an ad hoc independent opinion. The experts concerned shall undertake to act in the public interest and in a spirit of independence. For this purpose, they shall make a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be prejudicial to their independence. These declarations shall be made annually in writing and shall be verified by the European Commission. Amendment 88 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 10 – paragraph 2 – point c a (new) (ca) where an alert is notified pursuant to Article 9, the Commission shall, if it is necessary for the coordination of the response at Union level, make promptly available to the national competent authorities through the Early Warning and Information System and to the Health Security Committee referred to respectively in Articles 8 and 19 an assessment of the risks to public health; Amendment 89 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 10 – paragraph 2 – point c b (new) (cb) where a sudden man-made disaster occurs, on the opinion of the Monitoring and Information Centre, and/or Amendment 90 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 10 – paragraph 2 – point c c (new) (cc) information supplied by the Scientific Committee on Consumer Products, the Scientific Committee on Health and Environmental Risk or the Scientific Committee on Emerging and Newly Identified Health Risks. Amendment 91 # Rebecca TAYLOR, Frédérique RIES, Antonyia PARVANOVA Proposal for a decision Article 10 – paragraph 2 – point c a (new) (ca) on the assessment of the World Health Organisation, when provided, in the case of an international public health emergency. Amendment 92 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 11 – paragraph 2 2. Where a Member State intends to adopt public health measures to combat a serious cross-border threat to health, it shall, before adopting those measures, ~~consult~~inform the other Member States and the Commission, via the Early Warning and Information System, on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary, or this is required on grounds of national security. Amendment 93 # Sari ESSAYAH, Riikka PAKARINEN Proposal for a decision Article 11 – paragraph 2 2. Where a Member State intends to adopt public health measures to combat a serious cross-border threat to health, it shall~~, before adopting those measures, consult~~ inform the other Member States and the Commission on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary. Amendment 94 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 11 – paragraph 3 3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and the Commission, via the Early Warning and Information System, on the nature, purpose and scope of those measures. Amendment 95 # Sari ESSAYAH Proposal for a decision Article 11 – paragraph 4 4. ~~In the event of a serious cross-border health threat overwhelm~~Following an alert pursuant to Article 9, Member States shall inform and consult each other withing the ~~national response capacities, an affected Member State may also request assistance from other Member St~~Health Security Committee referred to in Article 17 and in liaison with the Commission with a view to coordinates, t~~hrough the EU Civil Protection Mechanism established by Council Decision 2007/779/EC, Euratom.~~o the extent possible, basic messages to be adapted to national needs and the actual situation in each Member State Amendment 96 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 11 – paragraph 5 5. The Commission shall, by means of implementing acts, adopt the procedures necessary for the uniform implementation of the mutual information, consultation and coordination provided for in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).deleted Amendment 97 # Sari ESSAYAH Proposal for a decision Article 12 Common temporary public health 1. Where the coordination of national responses provided for in Article 11 proves insufficient to control the spread of a serious cross-border threat to health between the Member States or to the Union, and, as a consequence, the protection of the health of the population of the Union as a whole is jeopardised, the Commission may complement the action of the Member States through the adoption, by means of delegated acts in accordance with the procedure provided for in Article 22, of common temporary public health measures to be implemented by the Member States. These measures may not concern the control of the threat concerned within each Member State. 2. Paragraph 1 shall apply only to serious cross-border health threats which may result in deaths or hospitalisations on a large scale across the Member States. 3. The measures adopted under paragraph 1 shall: (a) respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care; (b) be proportionate to the public health risks related to that threat, avoiding in particular any unnecessary restriction to the free movement of persons, of goods and of services; (c) be compatible with any applicable international obligation of the Union or of the Member States.Article 12 deleted measures Amendment 98 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 12 Common temporary public health 1. Where the coordination of national responses provided for in Article 11 proves insufficient to control the spread of a serious cross-border threat to health between the Member States or to the Union, and, as a consequence, the protection of the health of the population of the Union as a whole is jeopardised, the Commission may complement the action of the Member States through the adoption, by means of delegated acts in accordance with the procedure provided for in Article 22, of common temporary public health measures to be implemented by the Member States. These measures may not concern the control of the threat concerned within each Member State. 2. Paragraph 1 shall apply only to serious cross-border health threats which may result in deaths or hospitalisations on a large scale across the Member States. 3. The measures adopted under paragraph 1 shall: (a) respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care; (b) be proportionate to the public health risks related to that threat, avoiding in particular any unnecessary restriction to the free movement of persons, of goods and of services; (c) be compatible with any applicable international obligation of the Union or of the Member States.Article 12 deleted measures Amendment 99 # Frieda BREPOELS Proposal for a decision Article 13 – title Recognition of emergency situations ~~or of pandemic influenza situations~~ Amendment 100 # Frieda BREPOELS Proposal for a decision Article 13 – paragraph 1 – subparagraph 1 – point a (a) situations of emergency at Union level; or Amendment 101 # Frieda BREPOELS Proposal for a decision Article 13 – paragraph 1 – subparagraph 1 – point b ~~(b) pre-pandemic situations with respect to human influenza at Union level.~~deleted Amendment 102 # Frieda BREPOELS Proposal for a decision Article 13 – paragraph 1 – subparagraph 3 On duly justified imperative grounds of urgency related to the severity of a serious cross-border threat to health or to the rapidity of its spread among Member States, the Commission may formally recognise situations of emergency at Union level ~~or pre-pandemic situations with respect to human influenza at Union level~~ through immediately applicable implementing acts in accordance with the urgency procedure referred to in Article 20(3). Amendment 103 # Frieda BREPOELS Proposal for a decision Article 13 – paragraph 2 – point d ~~(d) with a view to the formal recognition of a pre-pandemic situation with respect to human influenza at the Union level, the threat concerned is human influenza.~~deleted Amendment 104 # Frieda BREPOELS Proposal for a decision Article 14 – paragraph 2 2. The recognition of a pre-pandemic situation with respect to human influenza at the Union level pursuant to point (b) of Article 13(1) shall have the sole legal effect of triggering the applicability of Article 2(2) of Regulation (EC) No 507/2006 and of Article 21 of Regulation (EC) No 1234/2008.deleted Amendment 105 # Sari ESSAYAH Proposal for a decision Article 16 The Union may conclude international agreements with third countries or international organisations allowing and organizing its cooperation with those third countries or international organisations on serious cross-border threats to health that pose particular risks of transmission to the population of the Union, in order to cover the following aspects: (a) exchange of good practice in the areas of preparedness and response planning, (b) exchange of relevant information from monitoring and alerting systems, including the participation of the countries or organisations concerned in the relevant epidemiological surveillance or ad hoc monitoring networks and the Early Warning and Response System, (c) collaboration on the public health risk assessment of serious cross-border threats to health, with special reference to public health emergencies of international concern declared in accordance with the International Health Regulations (2005), (d) collaboration on response coordination, including the occasional participation of the countries or organisations concerned in the Health Security Committee as observers, with special reference to public health emergencies of international concern declared in accordance with the International Health Regulations (2005).Article 16 deleted International agreements Amendment 106 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 16 The Union may conclude international agreements with third countries or international organisations allowing and organizing its cooperation with those third countries or international organisations on serious cross-border threats to health that pose particular risks of transmission to the population of the Union, in order to cover the following aspects: (a) exchange of good practice in the areas of preparedness and response planning, (b) exchange of relevant information from monitoring and alerting systems, including the participation of the countries or organisations concerned in the relevant epidemiological surveillance or ad hoc monitoring networks and the Early Warning and Response System, (c) collaboration on the public health risk assessment of serious cross-border threats to health, with special reference to public health emergencies of international concern declared in accordance with the International Health Regulations (2005), (d) collaboration on response coordination, including the occasional participation of the countries or organisations concerned in the Health Security Committee as observers, with special reference to public health emergencies of international concern declared in accordance with the International Health Regulations (2005).Article 16 deleted International agreements Amendment 107 # Frieda BREPOELS Proposal for a decision Article 17 – paragraph 1 – point a (a) the ~~competent~~relevant decision-making authorities responsible ~~at national level~~within the Member State for collecting information relating to epidemiological surveillance as referred to in Article 6; Amendment 108 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 17 – paragraph 1 – point b ~~(b) single contact points for the purpose of the coordination of the ad hoc monitoring, as referred to in Article 7;~~deleted Amendment 109 # Frieda BREPOELS Proposal for a decision Article 17 – paragraph 1 – point c (c) the ~~competent~~relevant decision-making authority or authorities responsible ~~at national level~~within the Member State for notifying alerts and determining the measures required to protect public health, for the purposes of Articles 8, 9, and 10; Amendment 110 # Frieda BREPOELS Proposal for a decision Article 19 – paragraph 1 1. A ‘Health Security Committee’, composed of representatives of the relevant decision-making authorities in the Member States at a high level, is hereby established. Amendment 111 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 19 – paragraph 2 – point a (a) ~~support the~~ exchange of information between the Member States and the Commission on the experience acquired with regard to the implementation of this Decision; Amendment 112 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 19 – paragraph 2 – point b (b) ~~assist the Commission in providing for the~~ coordinat~~ion of~~e the preparedness and response planning efforts of the Member States in accordance with Article 4; Amendment 113 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 19 – paragraph 2 – point c (c) ~~assist the Commission in providing for the~~ coordinat~~ion of~~e the responses of the Member States to serious cross-border threats to health, in accordance with Article 11. Amendment 114 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 19 – paragraph 2 – point c a (new) (ca) advise the Health Ministers and the Commission on the preparation and coordination of contingency plans. Amendment 115 # Frieda BREPOELS Proposal for a decision Article 19 – paragraph 4 a (new) 4a. The representatives concerned shall undertake to act in the public interest and in a spirit of independence. For this purpose, they shall make a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be prejudicial to their independence. These declarations shall be made annually in writing and shall be verified by the Commission. Amendment 116 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 21 ~~1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this~~ Article. 2. The power to adopt delegated acts referred to in Article 12 shall be conferred on the Commission for a period of five years after [...]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of powers referred to in Article 12 may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the powers specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated act already in force. 4. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 5. A delegated act adopted pursuant to Article 12 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or the Council. ____________________ EU Publications Office: Please insert the date: date of entry into force of this Decis1 deleted Exercise of the delegation Amendment 117 # Sari ESSAYAH Proposal for a decision Article 21 – paragraph 2 ~~2. The power to adopt~~ delegated acts referred to in Article 12 shall be conferred on the Commission for a period of five years after [...]1.The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. ________________ 1 . OJ: please insert the date: date of entry into force of this Decision. Amendment 118 # Sari ESSAYAH Proposal for a decision Article 22 ~~1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a~~Article 22 delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 21(5). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or by the Council.Urgency procedure Amendment 119 # Thomas ULMER, Anja WEISGERBER Proposal for a decision Article 22 ~~1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a~~Article 22 delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 21(5). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or by the Council.Urgency procedure source: PE-496.383

Amendments

Dossier

2011/0421(COD) Serious cross-border threats to health

2012/09/10 ENVI 3 amendments...

Amendment 1 #

Proposal for a decision
recital 10

(10) The European Parliament in its resolution of 8 March 2011 and the Council in its Conclusions of 13 September 2010 stressed the need to introduce a common procedure for the joint procurement of medical countermeasures, and in particular of pandemic vaccines, to allow Member States, on a voluntary basis, to benefit from such group purchases and to obtain advantageous prices and order flexibility with regard to a given product. With regard to pandemic vaccines, in the context of limited production capacities at global level, such a procedure ~~would increase the avail~~is undertaken with the aim of enabili~~ty of those products and ensure fairer access to them among M~~ng more equitable access to vaccines for the Member States involved, to help them be~~r States participating in the joint procurement~~tter meet the vaccination needs of their citizens, in line with vaccination policies in the Member States.

Amendment 2 #

Proposal for a decision
Article 2 – paragraph 2 a (new)

2a. in exceptional emergency situations where an EU mechanism for the coordination of public health measures in case of serious cross-border threats to health other than those covered in Article 2(1) (ie threats of biological, chemical and environmental origin) proves insufficient to ensure a high level of human health protection, Member States may refer such threats for a coordinated response to the Health Security Committee in accordance with Article 11, in close coordination with other Union areas, as appropriate.

Amendment 3 #

Proposal for a decision
Article 8-paragraph 1 bis (new)

The actors in the Early Warning and Response System shall undertake to act independently in the public interest. Prior to taking up their duties, they shall make available a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be prejudicial to their independence. Those declarations shall be updated when significant changes occur, and at least once a year. The declarations shall be verified by the Commission for actors at Union level, and by the relevant competent authority for actors at Member State level.

source: PE-496.640

2012/09/17 ENVI 87 amendments...

Amendment 33 #

	ENVI	IMCO
Lead Rapporteur	PARGNEAUX Gilles (S&D)
Opinion Rapporteur(s)

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activities/4/committees	deleted	body EP shadows group ALDE name TAYLOR Rebecca group GUE/NGL name MAŠTÁLKA Jiří group EFD name CYMAŃSKI Tadeusz responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO
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activities/5	deleted	date 2012-06-20 docs url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE491.305 type Committee draft report title PE491.305 body EP type Committee draft report
activities/10/date	changed	Old 2011-12-08 New 2013-05-20
activities/10/type	changed	Old EP officialisation New Indicative plenary sitting date, 1st reading/single reading

activities/1/commission/0/Commissioner	changed	Old DALLI John New BORG Tonio
activities/4/commission/0/Commissioner	changed	Old DALLI John New BORG Tonio
other/0/commissioner	changed	Old DALLI John New BORG Tonio

activities/9/committees	added	body EP shadows group ALDE name TAYLOR Rebecca group GUE/NGL name MAŠTÁLKA Jiří group EFD name CYMAŃSKI Tadeusz responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO
activities/9/type	changed	Old EP 1R Committee New Vote in committee, 1st reading/single reading

activities/2/committees	added	body EP shadows group ALDE name TAYLOR Rebecca group GUE/NGL name MAŠTÁLKA Jiří group EFD name CYMAŃSKI Tadeusz responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO
activities/2/date	changed	Old 2012-06-20 New 2012-01-17
activities/2/docs	deleted	url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE491.305 type Committee draft report title PE491.305
activities/2/type	changed	Old Committee draft report New Committee referral announced in Parliament, 1st reading/single reading
activities/4/committees	deleted	body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan group GUE/NGL name MAŠTÁLKA Jiří group EFD name CYMAŃSKI Tadeusz responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO
activities/4/date	changed	Old 2012-01-17 New 2012-06-20
activities/4/docs	added	url http://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE491.305 type Committee draft report title PE491.305
activities/4/type	changed	Old Committee referral announced in Parliament, 1st reading/single reading New Committee draft report
activities/7	added	date 2012-09-18 docs type Amendments tabled in committee title PE496.383 body EP type Amendments tabled in committee
committees/0/shadows/0/group	changed	Old EPP New ALDE
committees/0/shadows/0/mepref	changed	Old 4de184b90fb8127435bdbdf5 New 4f608c6cb819f2787f000001
committees/0/shadows/0/name	changed	Old FJELLNER Christofer New TAYLOR Rebecca
committees/0/shadows/1	deleted	group Verts/ALE name BREPOELS Frieda
committees/0/shadows/2	deleted	group ECR name CABRNOCH Milan

activities/3	added	date 2012-03-28 docs type Document attached to the procedure title N7-0082/2012 url http://eur-lex.europa.eu/JOHtml.do?uri=OJ:C:2012:197:SOM:EN:HTML type Document attached to the procedure title OJ C 197 05.07.2012, p. 0021 type Document attached to the procedure body EC commission DG url http://ec.europa.eu/dgs/health_consumer/index_en.htm title Health and Consumers Commissioner DALLI John
activities/8	added	body EP date 2012-11-07 type EP 1R Plenary
activities/9	added	body EC date 2012-11-07 type Prev DG PRES commission DG url http://ec.europa.eu/dgs/health_consumer/index_en.htm title Health and Consumers Commissioner DALLI John
activities/10/date	changed	Old 2012-11-07 New 2012-11-20
procedure/legal_basis	added	Treaty on the Functioning of the EU TFEU 168-p4 Treaty on the Functioning of the EU TFEU 168-p5

activities/4	deleted	date 2012-06-22 body unknown type Debate/examination by Council scheduled
activities/4/body	changed	Old EP New unknown
activities/4/date	changed	Old 2012-07-18 New 2012-06-22
activities/4/type	changed	Old Deadline Amendments New Debate/examination by Council scheduled
activities/5/date	changed	Old 2012-09-19 New 2012-09-17
activities/5/type	changed	Old EP 1R Committee New Deadline Amendments

activities/2/committees/0/shadows/3	added	group GUE/NGL name MAŠTÁLKA Jiří
activities/2/committees/0/shadows/4	added	group EFD name CYMAŃSKI Tadeusz
activities/3/body	changed	Old EP New unknown
activities/3/date	changed	Old 2012-06-07 New 2012-06-22
activities/3/type	changed	Old Deadline Amendments New Debate/examination by Council scheduled
activities/4	deleted	date 2012-06-22 body unknown type Debate/examination by Council scheduled
activities/4/date	changed	Old 2012-07-11 New 2012-07-18
activities/4/type	changed	Old EP 1R Committee New Deadline Amendments
committees/0/shadows/3	added	group GUE/NGL name MAŠTÁLKA Jiří
committees/0/shadows/4	added	group EFD name CYMAŃSKI Tadeusz
procedure/legal_basis	deleted	Treaty on the Functioning of the EU TFEU 168-p4 Treaty on the Functioning of the EU TFEU 168-p5

activities/1/body	changed	Old unknown New EC
activities/1/commission	added	DG url http://ec.europa.eu/dgs/health_consumer/index_en.htm title Health and Consumers Commissioner DALLI John
activities/1/date	changed	Old 2012-06-22 New 2011-12-08
activities/1/docs	added	text PURPOSE: establish a European initiative to combat serious cross-border threats to health. PROPOSED ACT: Decision of the European Parliament and of the Council. BACKGROUND: many activities related to preparedness and response planning and risk assessment for communicable diseases but also for chemical threats to health and events caused by climate change have been supported at European level, in particular the current Community network for the epidemiological surveillance and control of communicable diseases (see Decision No 2119/98/EC of the European Parliament and the Council establishing a network for the epidemiological surveillance and control of communicable diseases in the Community). The EU already has policies, mechanisms and instruments in place for the prevention and control of serious cross-border threats and for the development of capacities to manage crises. A non-exhaustive list includes the EU Civil Protection Mechanism, the Cohesion and Solidarity Funds, the EU action plan on chemical, biological, radiological and nuclear security, and European alert networks, such as ECURIE. In order to avoid overlaps with these areas and duplicating existing disaster prevention and control structures, a gap analysis has been carried out to assess how far these existing systems cover the monitoring of threats to health, their notification, risk assessment and crisis management capacities and structures from the public health perspective. This gap analysis revealed that the existing structures and mechanisms at EU level do not address these threats sufficiently as far as public health is concerned. The lack of public health risk assessment at EU level leads to discrepancies in evaluating the danger of a given threat, duplication of assessments between Member States and inconsistent measures at EU level. Such a situation can also lead to inefficient use of the limited resources currently available. Although the Member States have the responsibility to manage public health crises at national level, no country can tackle a cross border public health crisis on its own. At EU level, the legal basis for addressing serious cross-border health threats has been reinforced with the Lisbon Treaty. The EU can now take action in this field that complement and support national policies and encourage cooperation between Member States. This is the reason why it is proposed to create a new instrument to step up cooperation and strengthen coordination in the area of the notification and risk assessment. The aim is to streamline and strengthen European Union capacities and structures for effectively responding to serious cross-border health threats. These threats can be events caused by communicable diseases, biological agents responsible for non-communicable diseases, and threats of chemical, environmental, or unknown origin, as well as threats deriving from the effects of climate change. IMPACT ASSESSMENT: The Commission has carried out detailed analysis of three options: *Option 1: status quo: maintaining the current level of activities; Option 2:* separate and different handling of serious cross-border threats to health - enhanced EU cooperation through the use of soft instruments based on a voluntary approach; *Option 3: establishing a common EU legal framework covering all serious cross-border threats to health through improved cooperation and legally binding measures. The results of the analysis led to the conclusion that option 3 has the strongest positive health impacts* as it improves the protection of citizens against serious cross-border threats to health. LEGAL BASIS: Article 168, paragraphs (4)(c) and (5) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: this proposal lays down the rules on monitoring, early warning of and combating serious cross-border threats to health, as well as on preparedness and response planning related to those activities. It aims to support the prevention and control of the spread of severe human diseases across the borders of the Member States, and to obviate other major sources of serious cross-border threat to health in order to contribute to a high level of public health protection in the Union. Scope: the proposal applies in case of serious cross-border threats to health falling within the following categories: threats of biological origin, consisting of: (i) communicable diseases; (ii) antimicrobial resistance and healthcare-associated infections related to communicable diseases; (iii) biotoxins or other toxic biological agents not related to communicable diseases; threats of chemical origin with the exception of threats arising from ionizing radiation; threats of environmental origin, including threats deriving from the effects of climate change; threats of unknown origin; events which may constitute public health emergencies of international concern determined pursuant to the International Health Regulations (2005). General structure: the monitoring system revolves around the following four fields: 1) preparedness and response planning: the proposal provides for the coordination of the efforts of the Member States in terms of improved preparedness and capacity building. To this end, the Commission will ensure coordination between national planning and between key sectors such as transport, energy and civil protection, and will support Member States in setting up a joint procurement mechanism for medical countermeasures, e.g. vaccines against influenza, which would enable the EU to be better prepared for future pandemics; 2) establishment of an epidemiological monitoring network: to provide the relevant information and data for risk assessment and monitoring of emerging threats, an ad hoc network will be set up in situations where a Member State has raised an alert on a serious threat other than a communicable disease. Communicable diseases will continue to be monitored as they are today; 3) the use of the existing Early Warning and Response System to cover all serious threats to health, and not only communicable diseases as is the case today; 4) coordinated development of national or European public health risk assessments for threats of biological, chemical, environmental or unknown origin in a crisis situation. EU response to a public health crisis: the proposal sets up a coherent framework for the EU response to a public health crisis. In concrete terms, by formalising the existing Health Security Committee, the EU will be in a better position to coordinate national crisis responses in a public health emergency. A procedure for the mobilisation and coordination of the European response to a serious cross-border risk is proposed. Thus, if a Member State intends to adopt public health measures to combat a serious cross-border health risk, it shall, before adopting any measures consult the other Member States and the Commission on the nature, purpose and scope of the measures. The measures taken shall be decided by means of implementing acts. Provision is also made for the following specific measures: Common temporary public health measures to control the spread of a serious cross-border threat to health between the Member States or to the Union as a whole; Emergency and pandemic influenza situations at the Union level; International agreements with third countries or international organisations. BUDGETARY IMPACT: this legal proposal does not impact on decentralised agencies. In addition, the current EU health programme already covers some activities in relation to monitoring, alerting and risk assessment of some health threats. After 2013, the Commission intends to cover these activities under the proposed Health for growth programme 2014-2020. The cost is included in the proposed envelope of the new programme. DELEGATED ACTS: in accordance with Article 290 of the TFEU, the Commission should be empowered to adopt delegated acts in respect of measures needed to complement the action of the Member States, in very specific and urgent situations, for the transnational aspects of the control of serious cross-border threats to health. In order to ensure uniform conditions for the implementation of this Decision, implementing powers should be conferred on the Commission to adopt implementing acts in relation to: the procedures for the coordination, the exchange of information and the mutual consultation on preparedness and response planning; the adoption of a list of communicable diseases subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the setting up and termination of ad hoc monitoring networks and the procedures for the operation of such networks; the adoption of case definitions for serious cross-border threats to health; the procedures for the operation of the Early Warning and Response System; the procedures for the coordination of the responses of the Member States; the recognition of situations of emergency at Union level or of pre-pandemic situations with respect to human influenza at Union level. title COM(2011)0866 type Legislative proposal published celexid CELEX:52011PC0866:EN
activities/1/type	changed	Old Debate/examination by Council scheduled New Legislative proposal
activities/4/body	changed	Old EC New unknown
activities/4/commission	deleted	DG url http://ec.europa.eu/dgs/health_consumer/index_en.htm title Health and Consumers Commissioner DALLI John
activities/4/date	changed	Old 2011-12-08 New 2012-06-22
activities/4/docs	deleted	url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2011&nu_doc=866 text PURPOSE: establish a European initiative to combat serious cross-border threats to health. PROPOSED ACT: Decision of the European Parliament and of the Council. BACKGROUND: many activities related to preparedness and response planning and risk assessment for communicable diseases but also for chemical threats to health and events caused by climate change have been supported at European level, in particular the current Community network for the epidemiological surveillance and control of communicable diseases (see Decision No 2119/98/EC of the European Parliament and the Council establishing a network for the epidemiological surveillance and control of communicable diseases in the Community). The EU already has policies, mechanisms and instruments in place for the prevention and control of serious cross-border threats and for the development of capacities to manage crises. A non-exhaustive list includes the EU Civil Protection Mechanism, the Cohesion and Solidarity Funds, the EU action plan on chemical, biological, radiological and nuclear security, and European alert networks, such as ECURIE. In order to avoid overlaps with these areas and duplicating existing disaster prevention and control structures, a gap analysis has been carried out to assess how far these existing systems cover the monitoring of threats to health, their notification, risk assessment and crisis management capacities and structures from the public health perspective. This gap analysis revealed that the existing structures and mechanisms at EU level do not address these threats sufficiently as far as public health is concerned. The lack of public health risk assessment at EU level leads to discrepancies in evaluating the danger of a given threat, duplication of assessments between Member States and inconsistent measures at EU level. Such a situation can also lead to inefficient use of the limited resources currently available. Although the Member States have the responsibility to manage public health crises at national level, no country can tackle a cross border public health crisis on its own. At EU level, the legal basis for addressing serious cross-border health threats has been reinforced with the Lisbon Treaty. The EU can now take action in this field that complement and support national policies and encourage cooperation between Member States. This is the reason why it is proposed to create a new instrument to step up cooperation and strengthen coordination in the area of the notification and risk assessment. The aim is to streamline and strengthen European Union capacities and structures for effectively responding to serious cross-border health threats. These threats can be events caused by communicable diseases, biological agents responsible for non-communicable diseases, and threats of chemical, environmental, or unknown origin, as well as threats deriving from the effects of climate change. IMPACT ASSESSMENT: The Commission has carried out detailed analysis of three options: *Option 1: status quo: maintaining the current level of activities; Option 2:* separate and different handling of serious cross-border threats to health - enhanced EU cooperation through the use of soft instruments based on a voluntary approach; *Option 3: establishing a common EU legal framework covering all serious cross-border threats to health through improved cooperation and legally binding measures. The results of the analysis led to the conclusion that option 3 has the strongest positive health impacts* as it improves the protection of citizens against serious cross-border threats to health. LEGAL BASIS: Article 168, paragraphs (4)(c) and (5) of the Treaty on the Functioning of the European Union (TFEU). CONTENT: this proposal lays down the rules on monitoring, early warning of and combating serious cross-border threats to health, as well as on preparedness and response planning related to those activities. It aims to support the prevention and control of the spread of severe human diseases across the borders of the Member States, and to obviate other major sources of serious cross-border threat to health in order to contribute to a high level of public health protection in the Union. Scope: the proposal applies in case of serious cross-border threats to health falling within the following categories: threats of biological origin, consisting of: (i) communicable diseases; (ii) antimicrobial resistance and healthcare-associated infections related to communicable diseases; (iii) biotoxins or other toxic biological agents not related to communicable diseases; threats of chemical origin with the exception of threats arising from ionizing radiation; threats of environmental origin, including threats deriving from the effects of climate change; threats of unknown origin; events which may constitute public health emergencies of international concern determined pursuant to the International Health Regulations (2005). General structure: the monitoring system revolves around the following four fields: 1) preparedness and response planning: the proposal provides for the coordination of the efforts of the Member States in terms of improved preparedness and capacity building. To this end, the Commission will ensure coordination between national planning and between key sectors such as transport, energy and civil protection, and will support Member States in setting up a joint procurement mechanism for medical countermeasures, e.g. vaccines against influenza, which would enable the EU to be better prepared for future pandemics; 2) establishment of an epidemiological monitoring network: to provide the relevant information and data for risk assessment and monitoring of emerging threats, an ad hoc network will be set up in situations where a Member State has raised an alert on a serious threat other than a communicable disease. Communicable diseases will continue to be monitored as they are today; 3) the use of the existing Early Warning and Response System to cover all serious threats to health, and not only communicable diseases as is the case today; 4) coordinated development of national or European public health risk assessments for threats of biological, chemical, environmental or unknown origin in a crisis situation. EU response to a public health crisis: the proposal sets up a coherent framework for the EU response to a public health crisis. In concrete terms, by formalising the existing Health Security Committee, the EU will be in a better position to coordinate national crisis responses in a public health emergency. A procedure for the mobilisation and coordination of the European response to a serious cross-border risk is proposed. Thus, if a Member State intends to adopt public health measures to combat a serious cross-border health risk, it shall, before adopting any measures consult the other Member States and the Commission on the nature, purpose and scope of the measures. The measures taken shall be decided by means of implementing acts. Provision is also made for the following specific measures: Common temporary public health measures to control the spread of a serious cross-border threat to health between the Member States or to the Union as a whole; Emergency and pandemic influenza situations at the Union level; International agreements with third countries or international organisations. BUDGETARY IMPACT: this legal proposal does not impact on decentralised agencies. In addition, the current EU health programme already covers some activities in relation to monitoring, alerting and risk assessment of some health threats. After 2013, the Commission intends to cover these activities under the proposed Health for growth programme 2014-2020. The cost is included in the proposed envelope of the new programme. DELEGATED ACTS: in accordance with Article 290 of the TFEU, the Commission should be empowered to adopt delegated acts in respect of measures needed to complement the action of the Member States, in very specific and urgent situations, for the transnational aspects of the control of serious cross-border threats to health. In order to ensure uniform conditions for the implementation of this Decision, implementing powers should be conferred on the Commission to adopt implementing acts in relation to: the procedures for the coordination, the exchange of information and the mutual consultation on preparedness and response planning; the adoption of a list of communicable diseases subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the setting up and termination of ad hoc monitoring networks and the procedures for the operation of such networks; the adoption of case definitions for serious cross-border threats to health; the procedures for the operation of the Early Warning and Response System; the procedures for the coordination of the responses of the Member States; the recognition of situations of emergency at Union level or of pre-pandemic situations with respect to human influenza at Union level. celexid CELEX:52011PC0866:EN type Legislative proposal published title COM(2011)0866 type Document attached to the procedure title SEC(2011)1520
activities/4/type	changed	Old Legislative proposal New Debate/examination by Council scheduled

activities/1/docs/0/url	added	http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2011&nu_doc=866
activities/1/docs/1	added	type Document attached to the procedure title SEC(2011)1520
links/European Commission	deleted	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2011&DocNum=0421 title PreLex
links/National parliaments	deleted	url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2011&number=0421&appLng=EN title IPEX

activities/1/docs/1/title	changed	Old SEC(2011)1519 New SEC(2011)1520
activities/1/docs/2	deleted	url http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/sec/2011/1520/COM_SEC(2011)1520_EN.pdf type Document attached to the procedure title SEC(2011)1520
activities/4	added	date 2012-06-22 body unknown type Debate/examination by Council scheduled
links/European Commission	deleted	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2011&DocNum=0421 title PreLex

activities/1/commission/0	added	DG url http://ec.europa.eu/dgs/health_consumer/index_en.htm title Health and Consumers Commissioner DALLI John
activities/1/commission/0	deleted	DG Health and Consumers Commissioner DALLI John
activities/4	added	date 2012-07-11 body unknown type Vote scheduled in committee, 1st reading/single reading
activities/4	deleted	date 2012-07-11 body type Vote scheduled in committee, 1st reading/single reading
links/European Commission	deleted	url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2011&DocNum=0421 title PreLex
other/0	added	body EC dg url http://ec.europa.eu/dgs/health_consumer/index_en.htm title Health and Consumers commissioner DALLI John
other/0	deleted	body EC dg Health and Consumers commissioner DALLI John

procedure/legal_basis/0	added	TFEU 168-p4
procedure/legal_basis/0	deleted	Treaty on the Functioning of the EU TFEU 168-p4
procedure/legal_basis/1	added	TFEU 168-p5
procedure/legal_basis/1	deleted	Treaty on the Functioning of the EU TFEU 168-p5

activities/2	added	date 2012-01-17 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO
activities/2	deleted	date 2012-01-17 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO
committees/0	added	body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles
committees/0	deleted	body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles

activities/1	added	date 2011-12-08 docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2011&nu_doc=0866 celexid CELEX:52011PC0866:EN type Legislative proposal published title COM(2011)0866 type Document attached to the procedure title SEC(2011)1519 url http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/sec/2011/1520/COM_SEC(2011)1520_EN.pdf type Document attached to the procedure title SEC(2011)1520 type Legislative proposal body EC commission DG Health and Consumers Commissioner DALLI John
activities/1	deleted	date 2011-12-08 docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2011&nu_doc=0866 title COM(2011)0866 type Legislative proposal published celexid CELEX:52011PC0866:EN type Document attached to the procedure title SEC(2011)1520 body EC type Legislative proposal commission DG Health and Consumers Commissioner DALLI John
activities/2	added	date 2012-01-17 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO
activities/2	deleted	date 2012-01-17 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO
committees/0	added	body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles
committees/0	deleted	body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles

activities/1/docs/0/url	changed	Old http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2011&nu_doc=0866&model=guicheti New http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2011&nu_doc=0866
activities/2	added	date 2012-01-17 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO
activities/2	deleted	date 2012-01-17 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO
committees/0	added	body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles
committees/0	deleted	body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles
committees/1/committee_full	changed	Old Internal Market and Consumer Protection New Internal Market and Consumer Protection

activities	added	body EP date 2011-12-08 type EP officialisation date 2011-12-08 docs url http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2011&nu_doc=0866&model=guicheti celexid CELEX:52011PC0866:EN type Legislative proposal published title COM(2011)0866 type Document attached to the procedure title SEC(2011)1520 body EC commission DG Health and Consumers Commissioner DALLI John type Legislative proposal date 2012-01-17 body EP type Committee referral announced in Parliament, 1st reading/single reading committees body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO body EP date 2012-06-07 type Deadline Amendments date 2012-07-11 body type Vote scheduled in committee, 1st reading/single reading body EP date 2012-07-11 type EP 1R Committee date 2012-09-10 body EP type Indicative plenary sitting date, 1st reading/single reading body EC date 2012-09-10 type Prev DG PRES commission DG Health and Consumers Commissioner DALLI John
committees	added	body EP shadows group EPP name FJELLNER Christofer group Verts/ALE name BREPOELS Frieda group ECR name CABRNOCH Milan responsible True committee ENVI date 2012-01-10 committee_full Environment, Public Health and Food Safety rapporteur group S&D name PARGNEAUX Gilles body EP responsible False committee_full Internal Market and Consumer Protection committee IMCO
links	added	National parliaments url http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2011&number=0421&appLng=EN title IPEX European Commission url http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2011&DocNum=0421 title PreLex
other	added	body EC dg Health and Consumers commissioner DALLI John
procedure	added	dossier_of_the_committee ENVI/7/08163 reference 2011/0421(COD) subtype Legislation legal_basis Treaty on the Functioning of the EU TFEU 168-p4 Treaty on the Functioning of the EU TFEU 168-p5 stage_reached Awaiting Parliament 1st reading / single reading / budget 1st stage summary Repealing Decision 2119/98/EC instrument Decision title Serious cross-border threats to health type COD - Ordinary legislative procedure (ex-codecision) subject 2.20 Free movement of persons 4.20 Public health 4.20.01 Medicine, diseases, AIDS

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