BETA

52 Amendments of Thomas ULMER related to 2011/0421(COD)

Amendment 33 #
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 covermplement 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.
2012/09/17
Committee: ENVI
Amendment 35 #
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.
2012/09/17
Committee: ENVI
Amendment 36 #
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.
2012/09/17
Committee: ENVI
Amendment 39 #
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
2012/09/17
Committee: ENVI
Amendment 41 #
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.
2012/09/17
Committee: ENVI
Amendment 43 #
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.
2012/09/17
Committee: ENVI
Amendment 44 #
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).
2012/09/17
Committee: ENVI
Amendment 46 #
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.
2012/09/17
Committee: ENVI
Amendment 47 #
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
2012/09/17
Committee: ENVI
Amendment 48 #
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 StatInformation 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.
2012/09/17
Committee: ENVI
Amendment 50 #
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:
2012/09/17
Committee: ENVI
Amendment 52 #
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") ;
2012/09/17
Committee: ENVI
Amendment 53 #
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;
2012/09/17
Committee: ENVI
Amendment 55 #
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;
2012/09/17
Committee: ENVI
Amendment 56 #
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);
2012/09/17
Committee: ENVI
Amendment 57 #
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
2012/09/17
Committee: ENVI
Amendment 59 #
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
2012/09/17
Committee: ENVI
Amendment 60 #
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.
2012/09/17
Committee: ENVI
Amendment 61 #
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 targetn identified serious cross- border threat to health in a given population, while excluding the detection of other similar threats;
2012/09/17
Committee: ENVI
Amendment 63 #
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.
2012/09/17
Committee: ENVI
Amendment 64 #
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.
2012/09/17
Committee: ENVI
Amendment 65 #
Proposal for a decision
Article 4 – paragraph 1 – point b
(b) the consistent implementordination of core capacity requirements for surveillance and response as referred to in Articles 5 and 13 of the International Health Regulations (2005).
2012/09/17
Committee: ENVI
Amendment 67 #
Proposal for a decision
Article 4 – paragraph 1 – point b a (new)
(ba) the communication of ‘best practice’ plans.
2012/09/17
Committee: ENVI
Amendment 68 #
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;
2012/09/17
Committee: ENVI
Amendment 71 #
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
2012/09/17
Committee: ENVI
Amendment 73 #
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
2012/09/17
Committee: ENVI
Amendment 75 #
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
2012/09/17
Committee: ENVI
Amendment 76 #
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
2012/09/17
Committee: ENVI
Amendment 77 #
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
2012/09/17
Committee: ENVI
Amendment 78 #
Proposal for a decision
Article 8 – title
Establishment of an early warning and responseinformation system
2012/09/17
Committee: ENVI
Amendment 79 #
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 ResponseInformation 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.
2012/09/17
Committee: ENVI
Amendment 81 #
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 ResponseInformation 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.
2012/09/17
Committee: ENVI
Amendment 82 #
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.
2012/09/17
Committee: ENVI
Amendment 83 #
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 ResponseInformation System where the emergence or development of a serious cross-border threat to health fulfils the following conditions:
2012/09/17
Committee: ENVI
Amendment 84 #
Proposal for a decision
Article 9 – paragraph 3 – point h
(h) measures other than public health measures,deleted
2012/09/17
Committee: ENVI
Amendment 85 #
Proposal for a decision
Article 9 – paragraph 4
4. The Commission shall make available to the national competent authorities through the Early Warning and ResponseInformation 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.
2012/09/17
Committee: ENVI
Amendment 86 #
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
2012/09/17
Committee: ENVI
Amendment 88 #
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;
2012/09/17
Committee: ENVI
Amendment 89 #
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
2012/09/17
Committee: ENVI
Amendment 90 #
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.
2012/09/17
Committee: ENVI
Amendment 92 #
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, consultinform 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.
2012/09/17
Committee: ENVI
Amendment 94 #
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.
2012/09/17
Committee: ENVI
Amendment 96 #
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
2012/09/17
Committee: ENVI
Amendment 98 #
Proposal for a decision
Article 12
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 Common temporary public health measures
2012/09/17
Committee: ENVI
Amendment 106 #
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
2012/09/17
Committee: ENVI
Amendment 108 #
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
2012/09/17
Committee: ENVI
Amendment 111 #
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;
2012/09/17
Committee: ENVI
Amendment 112 #
Proposal for a decision
Article 19 – paragraph 2 – point b
(b) assist the Commission in providing for the coordination ofe the preparedness and response planning efforts of the Member States in accordance with Article 4;
2012/09/17
Committee: ENVI
Amendment 113 #
Proposal for a decision
Article 19 – paragraph 2 – point c
(c) assist the Commission in providing for the coordination ofe the responses of the Member States to serious cross-border threats to health, in accordance with Article 11.
2012/09/17
Committee: ENVI
Amendment 114 #
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.
2012/09/17
Committee: ENVI
Amendment 116 #
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:1 deleted Exercise of the delegation date of entry into force of this Decision
2012/09/17
Committee: ENVI
Amendment 119 #
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 aArticle 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
2012/09/17
Committee: ENVI