52 Amendments of Thomas ULMER related to 2011/0421(COD)
Amendment 33 #
Proposal for a decision
Recital 1
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.
Amendment 35 #
Proposal for a decision
Recital 3
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 #
Proposal for a decision
Recital 5
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 39 #
Proposal for a decision
Recital 11
Recital 11
Amendment 41 #
Proposal for a decision
Recital 12
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 43 #
Proposal for a decision
Recital 13
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 #
Proposal for a decision
Recital 14
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 46 #
Proposal for a decision
Recital 19
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 #
Proposal for a decision
Recital 20
Recital 20
Amendment 48 #
Proposal for a decision
Recital 21
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.
Amendment 50 #
Proposal for a decision
Article 2 – paragraph 1 – introductory part
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 52 #
Proposal for a decision
Article 2 – paragraph 1 – point a – point ii
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 #
Proposal for a decision
Article 2 – paragraph 1 – point b
Article 2 – paragraph 1 – point b
(b) acute threats of chemical origin with the exception of threats arising from ionizing radiation;
Amendment 55 #
Proposal for a decision
Article 2 – paragraph 1 – point c
Article 2 – paragraph 1 – point c
(c) acute threats of environmental origin, including threats deriving from the effects of climate change;
Amendment 56 #
Proposal for a decision
Article 2 – paragraph 1 – point d
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 #
Proposal for a decision
Article 2 – paragraph 2
Article 2 – paragraph 2
Amendment 59 #
Proposal for a decision
Article 2 – paragraph 3
Article 2 – paragraph 3
Amendment 60 #
Proposal for a decision
Article 2 a (new)
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 #
Proposal for a decision
Article 3 – paragraph 1 – point a
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;
Amendment 63 #
Proposal for a decision
Article 3 – paragraph 1 a (new)
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 #
Proposal for a decision
Article 3 a (new)
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 #
Proposal for a decision
Article 4 – paragraph 1 – point b
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).
Amendment 67 #
Proposal for a decision
Article 4 – paragraph 1 – point b a (new)
Article 4 – paragraph 1 – point b a (new)
(ba) the communication of ‘best practice’ plans.
Amendment 68 #
Proposal for a decision
Article 4 – paragraph 2 – point i
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 71 #
Proposal for a decision
Article 4 – paragraph 4
Article 4 – paragraph 4
Amendment 73 #
Proposal for a decision
Article 4 – paragraph 5 – subparagraph 1
Article 4 – paragraph 5 – subparagraph 1
Amendment 75 #
Proposal for a decision
Article 7 – paragraph 1
Article 7 – paragraph 1
Amendment 76 #
Proposal for a decision
Article 7 – paragraph 2
Article 7 – paragraph 2
Amendment 77 #
Proposal for a decision
Article 7 – paragraph 3
Article 7 – paragraph 3
Amendment 78 #
Proposal for a decision
Article 8 – title
Article 8 – title
Establishment of an early warning and responseinformation system
Amendment 79 #
Proposal for a decision
Article 8 – paragraph 1
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.
Amendment 81 #
Proposal for a decision
Article 8 – paragraph 2
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.
Amendment 82 #
Proposal for a decision
Article 8 a (new)
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 #
Proposal for a decision
Article 9 – paragraph 1 – introductory part
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:
Amendment 84 #
Proposal for a decision
Article 9 – paragraph 3 – point h
Article 9 – paragraph 3 – point h
Amendment 85 #
Proposal for a decision
Article 9 – paragraph 4
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.
Amendment 86 #
Proposal for a decision
Article 10 – paragraph 2 – point c
Article 10 – paragraph 2 – point c
Amendment 88 #
Proposal for a decision
Article 10 – paragraph 2 – point c a (new)
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 #
Proposal for a decision
Article 10 – paragraph 2 – point c b (new)
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 #
Proposal for a decision
Article 10 – paragraph 2 – point c c (new)
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 92 #
Proposal for a decision
Article 11 – paragraph 2
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.
Amendment 94 #
Proposal for a decision
Article 11 – paragraph 3
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 96 #
Proposal for a decision
Article 11 – paragraph 5
Article 11 – paragraph 5
Amendment 98 #
Proposal for a decision
Article 12
Article 12
Amendment 106 #
Proposal for a decision
Article 16
Article 16
Amendment 108 #
Proposal for a decision
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
Amendment 111 #
Proposal for a decision
Article 19 – paragraph 2 – point a
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 #
Proposal for a decision
Article 19 – paragraph 2 – point b
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;
Amendment 113 #
Proposal for a decision
Article 19 – paragraph 2 – point c
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.
Amendment 114 #
Proposal for a decision
Article 19 – paragraph 2 – point c a (new)
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 116 #
Proposal for a decision
Article 21
Article 21
Amendment 119 #
Proposal for a decision
Article 22
Article 22