REPORT on the proposal for a decision of the European Parliament and of the Council on serious cross-border threats to health

17.10.2012 - (COM(2011)0866 – C7‑0488/2011 – 2011/0421(COD)) - ***I

Committee on the Environment, Public Health and Food Safety
Rapporteur: Gilles Pargneaux

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

on the proposal for a decision of the European Parliament and of the Council on serious cross-border threats to health

(COM(2011)0866 – C7-0488/2011 – 2011/0421(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

–   having regard to the Commission proposal to Parliament and the Council (COM(2011)0866),

–   having regard to Article 294(2) and Article 168(4)(c) and Article 168(5) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C7‑0488/2011),

–   having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–   having regard to the opinion of the European Economic and Social Committee of 28 March 2012[1],

–   after consulting the Committee of the Regions,

–   having regard to Rule 55 of its Rules of Procedure,

–   having regard to the report of the Committee on the Environment, Public Health and Food Safety (A7-0337/2012),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it intends to amend its proposal substantially or replace it with another text;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Amendment   1 Proposal for a decision Recital 5
Text proposed by the Commission	Amendment
(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. 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.	(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. In the event of a threat that did not arise from a transmissible disease, the ECDC should respond only in cooperation with the competent authority, at the request of that authority. 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.
Justification
The ECDC’s mandate, apart from transmissible diseases, should also be defined by this Decision.
Amendment  2 Proposal for a decision Recital 8 a (new)
Text proposed by the Commission	Amendment
	(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  3 Proposal for a decision Recital 10
Text proposed by the Commission	Amendment
(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 availability of those products and ensure fairer access to them among Member States participating in the joint procurement.	(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 is undertaken with the aim of enabling more equitable access to vaccines for the Member States involved, to help them better meet the vaccination needs of their citizens, in line with vaccination policies in the Member States.
Amendment   4 Proposal for a decision Recital 10 a (new)
Text proposed by the Commission	Amendment
	(10a) Cooperation with the competent international organisations, in particular the World Health Organisation, especially with regard to the classification of threats, should be strengthened.
Justification
Cooperation with the competent international organisations, in particular the World Health Organisation (WHO), should be emphasised more within this Decision.
Amendment   5 Proposal for a decision Recital 11 a (new)
Text proposed by the Commission	Amendment
	(11a) Cooperation with third countries, particularly regarding the emergence or re-emergence of transmissible diseases, should be strengthened.
Justification
Cooperation with third countries should be emphasised more within this Decision.
Amendment  6 Proposal for a decision Recital 13
Text proposed by the Commission	Amendment
(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.	(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, or the relevant decision-making authorities in the Member States, should verify those declarations.
Justification
To ensure independence and transparency, conflicts of interest must be prevented by means of declarations of commitments and interests. It is crucial that these declarations should also be checked.
Amendment   7 Proposal for a decision Recital 16
Text proposed by the Commission	Amendment
(16) Inconsistent or confusing communication with the public and stakeholders such as health professionals may have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators. Therefore, the coordination of the response at the Union level should encompass shared information campaigns and consistent communication messages to citizens based on robust and independent evaluation of public health risks.	(16) Inconsistent or confusing communication with the public and stakeholders such as health professionals may have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators. Therefore, the coordination of the response at Union level should encompass shared information campaigns and consistent communication messages to citizens based on robust and independent evaluation of public health risks. Proper communication strategies would allow the Member States and the Commission to monitor the clarity and coherence of the information content of the message to the public, particularly concerning the nature and characteristics of the threat, the best way of preventing it and the risks and benefits of protection and/or treatment.
Justification
The E. coli/STEC O104 crisis was a clear example of how a poor communication strategy could hinder the proper management of a crisis and lead to serious economic consequences. This Decision should further stress the importance of implementing a consistent and coordinated communication strategy should a crisis arise.
Amendment  8 Proposal for a decision Recital 17
Text proposed by the Commission	Amendment
(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.	(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.
Justification
The identification of the seed virus necessary for the production of vaccines is a role performed by the WHO. Vaccine manufacturers are dependent on the WHO's undertaking of this task in order to produce influenza (seasonal or pandemic) vaccines. While the EU can unilaterally alter the marketing authorisation of vaccines, the actual production patterns will still depend on the WHO's declaration and identification of the seed virus.
Amendment   9 Proposal for a decision Recital 17 a (new)
Text proposed by the Commission	Amendment
	(17a) The occurrence of an event that is linked with serious cross-border threats to health and is likely to have Europe-wide consequences may compel the Member States concerned to take particular control or contact tracing measures in a concerted manner to identify those persons already contaminated and those persons exposed to risk. Such cooperation may require the exchange of personal data through the system, including sensitive information related to health, confirmed or suspected human cases, amongst those Member States directly affected by the contact tracing measures.
Justification
This Recital refers explicitly to contact tracing.
Amendment   10 Proposal for a decision Recital 20
Text proposed by the Commission	Amendment
(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.	(20) The power to adopt acts in accordance with Article 290 of the Treaty on the functioning of the European Union should be delegated to the Commission in respect of the adoption of the procedures for the coordination, the exchange of information and the mutual consultation on preparedness and response planning, the adoption of case definitions for serious cross-border threats to health, the adoption of procedures for the operation of the Early Warning and Response System, the adoption of procedures for the coordination of responses of Member States following an alert notification and the adoption 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 a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
Justification
This Decision should offer additional clarification on the procedures for coordination, the exchange of information and mutual consultation on preparedness and response planning as well as the procedures for the operation of the Early Warning and Response System.
Amendment   11 Proposal for a decision Recital 21
Text proposed by the Commission	Amendment
(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 States; the recognition of situations of emergency at Union level or of pre-pandemic situations with respect to human influenza at Union level. Those 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.	(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 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 recognition of situations of emergency at Union level. Those 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.
Justification
This Decision should offer additional clarification on the procedures for coordination, the exchange of information and mutual consultation on preparedness and response planning as well as the procedures for the operation of the Early Warning and Response System.
Amendment  12 Proposal for a decision Recital 22 a (new)
Text proposed by the Commission	Amendment
	(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.
Justification
This is intended as a horizontal amendment applicable to the whole text. In view of its importance, this point is also explicitly inserted in the amendments to Articles 17 (designation of national authorities and representatives) and 19 (Health Security Committee).
Amendment   13 Proposal for a decision Article 1 – paragraph 2 a (new)
Text proposed by the Commission	Amendment
	2a. This Decision defines 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.
Justification
This introductory chapter should also address the question of the roles, duties and responsibilities of the key actors as well as the necessary coordination between them. These references are lacking in Article 1.
Amendment  14 Proposal for a decision Article 2 – paragraph 1 – point a – point i
Text proposed by the Commission	Amendment
(i) communicable diseases;	(i) communicable diseases, including human zoonotic infections;
Amendment  15 Proposal for a decision Article 2 – paragraph 2 a (new)
Text proposed by the Commission	Amendment
	2a. In exceptional emergency situations where a Union 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) (i.e. 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  16 Proposal for a decision Article 3 – paragraph 1 – point a
Text proposed by the Commission	Amendment
(a) ‘case definition’ means a set of commonly agreed diagnostic criteria that must be fulfilled in order to accurately detect cases of a targeted serious cross-border threat to health in a given population, while excluding the detection of other similar threats;	(a) ‘case definition’ means a set of commonly agreed diagnostic criteria that must be fulfilled in order to accurately detect cases of an identified serious cross-border threat to health in a given population, while excluding the detection of other similar threats;
Amendment  17 Proposal for a decision Article 3 – paragraph 1 – point b
Text proposed by the Commission	Amendment
(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, product or environment, or exchange of fluid, contaminated with the contagious agent;	(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;
Justification
The addition of "animal" makes sure that the proposal also covers zoonoses (infectious diseases that can be transmitted from animal to human).
Amendment  18 Proposal for a decision Article 4 – paragraph 1 – point b a (new)
Text proposed by the Commission	Amendment
	(ba) 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. Those measures shall include information on good hygiene measures, such as effective hand washing and drying, in healthcare environments, food establishments, schools and nurseries, entertainment facilities, and also in the working environment, and shall take into account the existing recommendations of the World Health Organisation.
Amendment  19 Proposal for a decision Article 4 – paragraph 1 – point b b (new)
Text proposed by the Commission	Amendment
	(bb) the communication of ‘best practices’.
Amendment  20 Proposal for a decision Article 4 – paragraph 2 – point i
Text proposed by the Commission	Amendment
(i) minimum core capacity standards determined at national level for the health sector;	(i) minimum core capacity standards determined at national level for the health sector; those standards shall also relate to preparations in the field of psychosocial emergency care;
Amendment  21 Proposal for a decision Article 4 – paragraph 2 – point ii
Text proposed by the Commission	Amendment
(ii) specific mechanisms established at national level for the interoperability between the health sector and other critical sectors of society;	(ii) specific mechanisms established at national level for the interoperability between the health sector, the veterinary sector and other critical sectors of society;
Justification
According to the World Health Organisation, more than 60% of human infections are zoonoses originating in animals or animal products. To combat cross-border threats to health as effectively as possible, an holistic ‘One Health’ approach needs to be taken, with coordination and close cooperation between the human health and veterinary sectors being a crucial component of this.
Amendment  22 Proposal for a decision Article 4 – paragraph 2 – point iii a (new)
Text proposed by the Commission	Amendment
	(iiia) specific mechanisms to monitor and report on vaccines coverage in respect of the diseases listed in the Annex to Decision 2119/98/EC.
Justification
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.
Amendment   23 Proposal for a decision Article 4 – paragraph 5 – subparagraph 1
Text proposed by the Commission	Amendment
5. 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. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).	5. The Commission shall be empowered to adopt delegated acts in accordance with Article 21 concerning the division of roles and responsibilities among the key actors in preparedness and response planning as well as the procedures for the coordination, the exchange of information and the mutual consultation referred to in this Article.
Justification
The decision should be more precise with regard to the division of roles and responsibilities among the key actors in preparedness and response planning.
Amendment   24 Proposal for a decision Article 7 – paragraph 3 – subparagraph 1 – point d
Text proposed by the Commission	Amendment
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;	deleted
Justification
This decision must provide more details on the case definitions to be used for ad hoc monitoring.
Amendment   25 Proposal for a decision Article 7 – paragraph 3 a (new)
Text proposed by the Commission	Amendment
	3a. The Commission shall be empowered to adopt delegated acts in accordance with Article 21 concerning the adoption of 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;
Justification
This decision must provide more details on the case definitions to be used for ad hoc monitoring.
Amendment   26 Proposal for a decision Article 8 – paragraph 1
Text proposed by the Commission	Amendment
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 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.	1. A rapid alert system for notifying at Union level alerts in relation to serious cross-border threats to health, ‘Early Warning and Response System’, is hereby established. This system shall bring into permanent communication the Commission, the ECDC 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.
Justification
As a key actor in the Early Warning Response System, the ECDC should be in constant contact with the Commission and the Member States.
Amendment  27 Proposal for a decision Article 8 – paragraph 1 a (new)
Text proposed by the Commission	Amendment
	1a. 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.
Amendment   28 Proposal for a decision Article 8 - paragraph 1 b (new)
Text proposed by the Commission	Amendment
	1b. 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.
	The strategy shall take into account the specific capacity and responsibilities of each member of the system, that is the person responsible for communication in the field of public health risk assessment within the Commission and the person responsible for communication within the Health Security Committee, in order to organise coordinated, consistent and transparent communication for citizens.
	Member States directly affected by the crisis shall implement all provisions to ensure that their communication is consistent with the communication strategy coordinated by the Health Security Committee.
	The strategy shall propose in particular the channels of communication that should be used in line with the case in hand, together with the European Parliament, the parties concerned and third countries.
Justification
The E. coli/STEC O104 crisis was a clear example of how a poor communication strategy can hinder the proper management of a crisis and lead to serious economic consequences. This decision should further stress the importance of implementing a consistent and coordinated communication strategy should a crisis arise. A specific article relating to this issue should be included in this decision.
Amendment   29 Proposal for a decision Article 8 – paragraph 2
Text proposed by the Commission	Amendment
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 System and the uniform implementation of Articles 8 and 9. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).	2. The Commission shall be empowered to adopt delegated acts in accordance with Article 21 concerning the adoption of procedures concerning the information exchange in order to ensure the proper functioning of the Early Warning and Response System.
Justification
This decision should be more precise with regard to how the information exchange needed for the proper functioning of the Early Warning and Response System will take place.
Amendment   30 Proposal for a decision Article 10 - point d (new)
Text proposed by the Commission	Amendment
	(d) on the assessment provided by the World Health Organisation in the event of an international public health emergency.
Justification
Public health risk assessment should also be based on the opinion of the WHO in the case of an international public health emergency.
Amendment   31 Proposal for a decision Article 11 - paragraph 4 a (new)
Text proposed by the Commission	Amendment
	4a. In the event of a serious cross-border threat to health, Member States shall coordinate their messages and communication campaigns in order to deliver consistent, harmonised information.
Justification
The E. coli/STEC O104 crisis was a clear example of how a poor communication strategy can hinder the proper management of a crisis and lead to serious economic consequences. This decision should further stress the importance of implementing a consistent and coordinated communication strategy should a crisis arise.
Amendment   32 Proposal for a decision Article 11 – paragraph 5
Text proposed by the Commission	Amendment
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.	5. The Commission shall be empowered to adopt delegated acts in accordance with Article 21 concerning the division of roles and responsibilities among the key actors in the coordination and the procedures for mutual information, consultation and coordination referred to in this Article.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 20(2).
Justification
This decision should be more precise with regard to how roles and responsibilities will be divided among the key actors in the Early Warning and Response System.
Amendment   33 Proposal for a decision Article 12 – paragraph 3 - point c a (new)
Text proposed by the Commission	Amendment
	(ca) be consistent with the recommendations established by the World Health Organisation in the event of an international public health emergency.
Justification
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.
Amendment   34 Proposal for a decision Article 12 – paragraph 3 – subparagraph 1 a (new)
Text proposed by the Commission	Amendment
	The Commission shall specify the reasons for adopting those measures.
Justification
When adopting common temporary public health measures, the Commission must specify the reasons for adopting these measures.
Amendment  35 Proposal for a decision Article 13 – title
Text proposed by the Commission	Amendment
Recognition of emergency situations or of pandemic influenza situations	Recognition of emergency situations
Justification
‘Emergency situations’ covers everything. There is no need to specify pandemic influenza situations separately.
Amendment  36 Proposal for a decision Article 13 – paragraph 1 – subparagraph 1 – point a
Text proposed by the Commission	Amendment
(a) situations of emergency at Union level; or	situations of emergency at Union level.
Justification
‘Emergency situations’ covers everything. There is no need to specify pre-pandemic influenza situations separately.
Amendment  37 Proposal for a decision Article 13 – paragraph 1 – subparagraph 1 – point b
Text proposed by the Commission	Amendment
(b) pre-pandemic situations with respect to human influenza at Union level.	deleted
Justification
‘Emergency situations’ covers everything. There is no need to specify pre-pandemic influenza situations separately.
Amendment  38 Proposal for a decision Article 13 – paragraph 1 – subparagraph 3
Text proposed by the Commission	Amendment
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).	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 through immediately applicable implementing acts in accordance with the urgency procedure referred to in Article 20(3).
Justification
‘Emergency situations’ covers everything. There is no need to specify pre-pandemic influenza situations separately.
Amendment  39 Proposal for a decision Article 13 – paragraph 2 – point d
Text proposed by the Commission	Amendment
(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
Justification
‘Emergency situations’ covers everything. There is no need to specify pre-pandemic influenza situations separately.
Amendment  40 Proposal for a decision Article 14 – paragraph 2
Text proposed by the Commission	Amendment
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
Justification
‘Emergency situations’ covers everything. There is no need to specify pre-pandemic influenza situations separately.
Amendment  41 Proposal for a decision Article 17 – paragraph 1 – point a
Text proposed by the Commission	Amendment
(a) the competent authorities responsible at national level for collecting information relating to epidemiological surveillance as referred to in Article 6;	(a) the relevant decision-making authorities responsible within the Member State for collecting information relating to epidemiological surveillance as referred to in Article 6;
Justification
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   42 Proposal for a decision Article 17 – paragraph 1 – subparagraph 1 a (new)
Text proposed by the Commission	Amendment
	The appointment of relevant decision-making authorities and representatives who are part of the Union network established by this Decision shall be made public by the Member States.
Justification
This decision should emphasise the public nature of the appointment of structures or authorities which are part of the Community network.
Amendment   43 Proposal for a decision Article 18 - paragraph 5 a (new)
Text proposed by the Commission	Amendment
	5a. Those responsible for processing personal data shall take the appropriate technical and organisational measures to protect those data against accidental or illegal destruction, accidental loss, alteration, distribution or unauthorised access and against any form of illegal processing.
Justification
This decision must recall the confidentiality of personal data.
Amendment   44 Proposal for a decision Article 18 - paragraph 5 b (new)
Text proposed by the Commission	Amendment
	5b. In accordance with the provisions on data protection laid down in point (e) of Article 4(1) of Regulation (EC) No 45/2001 and in point (e) of Article 6(1) of Directive 95/46/EC, the system shall automatically delete any selective messages containing personal data 12 months after the date on which those messages were sent.
Justification
This decision should recall the time limit for retaining personal data.
Amendment  45 Proposal for a decision Article 19 – paragraph 1
Text proposed by the Commission	Amendment
1. A ‘Health Security Committee’, composed of representatives of Member States at a high level, is hereby established.	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.
Justification
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  46 Proposal for a decision Article 19 – paragraph 2 – point c a (new)
Text proposed by the Commission	Amendment
	(ca) advise the health ministers of the Member States and the Commission on the preparation and coordination of contingency plans.
Amendment   47 Proposal for a decision Article 21
Text proposed by the Commission	Amendment
1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article.	1. The power to adopt 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.	2. The power to adopt delegated acts referred to in Article 4(5), Article 7(3a), Article 8(2), Article 11(5) and Article 12 shall be conferred on the Commission for a period of five years from […]. 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 acts already in force.	3. The delegation of powers referred to in Article 4(5), Article 7(3a), Article 8(2), Article 11(5) and 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 power 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 acts 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.	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.	5. A delegated act adopted pursuant to Article 4(5), Article 7(3a), Article 8(2), Article 11(5) and 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 two 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 two months at the initiative of the European Parliament or of the Council.
	(The changes in italics in paragraphs 2, 3 and 5 of Article 21 are technical changes introduced by the services as a consequence of amendments 23, 25, 29 and 32.)
Justification
The delegation of powers to the Commission should be subject to clear conditions in the case of the delegated acts referred to in Article 12, particularly for common temporary public health measures put in place when the coordination of national responses proves insufficient. The three-year period ensures the better safeguarding of the powers of the European Parliament.
Amendment   48 Proposal for a decision Article 23
Text proposed by the Commission	Amendment
The Commission shall submit to the European Parliament and the Council every three years a technical report on the activities of the Early Warning and Response System and other activities carried out in the context of the implementation of this Decision.	The Commission shall submit a report to the European Parliament and the Council every three years containing an assessment of the functioning of the Early Warning and Response System.
	The first report, which shall be submitted within three years of the entry into force of this Decision, shall assess the activities of the Early Warning and Response System and other activities carried out in the context of the implementation of this Decision. It shall also include any proposals to amend or adapt this Decision as considered necessary by the Commission.
	Every time common temporary public health measures are adopted under Article 12, and at the latest two months after the date on which these measures are adopted, the Commission shall 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.
Justification
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.

• [1]  OJ C 181, 21.6.2012, p. 160.

EXPLANATORY STATEMENT

Context

Having learned from recent crises such as the H1N1 ‘pandemic’ in 2009, the volcanic ash cloud in 2010 and the E. coli bacteria in 2011, on 8 December 2011 the Commission submitted a proposal for a decision establishing measures and structures for the effective protection of citizens throughout Europe from a wide range of cross-border threats to health.

Subject of the proposal for a decision

Based on the Early Warning and Response System set up in 1988 for communicable diseases, the Commission’s proposal presents measures aimed at reinforcing the European Union’s response capacity to prevent serious cross-border threats to health by providing it with resources, networks and structures to complement those already in place in order to combat these threats.

The proposal for a decision is based on the existing structures, reinforcing them using the measures listed below:

- extending the scope of the risk assessment and coordination measures which are currently applied to communicable diseases to all threats to health of biological, chemical or environmental origin.

- strengthening the role of the Health Security Committee with a view to better coordination of measures to combat crises.

- greater preparation in the fight against crises, requiring each Member State to draw up, consolidate and update its national preparation and response plans for dealing with health crises in a coordinated manner, in liaison with the other Member States and the Commission.

- the possibility of recognising a European ‘health emergency’ with the aim of speeding up the provision of the medication needed to combat the crisis.

- the adoption of emergency cross-border measures by the European Commission at European level in exceptional circumstances arising from large-scale deaths or hospitalisations when the Member States’ measures prove insufficient to manage the spread from one country to another.

In the interests of clarity and legal certainty, this decision repeals Decision No 2119/98/EC setting up a network for the epidemiological surveillance and control of communicable diseases in the Community.

Rapporteur’s position

Your rapporteur welcomes this proposal for a decision on cross-border threats, particularly in terms of the coordination and efficiency of responses in the event of serious health threats.

In order to improve upon this sound legislative basis, your rapporteur proposes to amend the draft decision in the following areas:

Scope of the decision

Through this decision, the Commission hopes to ‘extend the Early Warning and Response System to cover all serious cross-border threats to health’. In this way, the Commission intends to fill the gaps that have been identified in recent years in the health sector regarding notification, monitoring, risk assessment and risk management.

Recent events have shown the lack of responsiveness of the European Union with respect to health crises arising from misuse of medication or the sale of defective medical devices. An effective warning system would certainly have prevented such dramatic events. That is why your rapporteur proposes to extend the scope of this decision to threats arising from misuse of medication or the sale of defective medical devices.

Contrary to the European Commission, your rapporteur believes that serious cross-border threats to health arising from ionising radiation should be an integral part of the global approach advocated in this decision. The nuclear disaster in Fukushima in March 2011 reminds us how crucial it is to be capable of responding rapidly to the health risks arising from such a catastrophe.

Communication strategy 

The E. coli/STEC O104 crisis was a clear example of how a poor communication strategy could hinder the proper management of a crisis and lead to serious economic consequences. Your rapporteur believes that this decision should further stress the importance of implementing a consistent and coordinated communication strategy should a crisis arise.

Independence of experts 

This decision recalls the independence of experts in a broad and general manner. Given that the Early Warning and Response System relies heavily on the work of experts, an article should be devoted to the independence and transparency that they must display.

Protection of personal data 

According to your rapporteur, the exchange of data within the framework of researching contacts should be the subject of a specific paragraph, given the importance that the European Union accords to the protection of personal data. This decision should recall the principles of confidentiality and the time limit for retaining personal data.

Mandate of the European Centre for Disease Prevention and Control‭ 

The mandate of the European Centre for Disease Prevention and Control (ECDC), beyond communicable diseases, should also be defined by this decision. The importance of its continued cooperation with the European Commission and the Member States should also be noted.

Cooperation with the WHO and third countries

Cooperation by members of the system with the competent international organisations, in particular the World Health Organisation (WHO), should be emphasised more within this decision. Cooperation with third countries should also be recalled.

Procedures for common purchases of medical countermeasures

Your rapporteur highlights that equitable access to vaccines and a certain degree of order flexibility should be guaranteed by the time of the next pandemics.

Regular dialogue with the European Parliament

Regular dialogue must 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, your rapporteur proposes that the Commission should 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 health threat within the two months following the adoption of measures. 

PROCEDURE

Title	Serious cross-border threats to health
References	COM(2011)0866 – C7-0488/2011 – 2011/0421(COD)
Date submitted to Parliament	8.12.2011
Committee responsible        Date announced in plenary	ENVI 17.1.2012
Committee(s) asked for opinion(s)        Date announced in plenary	IMCO 17.1.2012
Not delivering opinions        Date of decision	IMCO 29.2.2012
Rapporteur(s)        Date appointed	Gilles Pargneaux 10.1.2012
Discussed in committee	20.6.2012	10.7.2012
Date adopted	10.10.2012
Result of final vote	+: –: 0:	52 0 6
Members present for the final vote	Martina Anderson, Kriton Arsenis, Sophie Auconie, Pilar Ayuso, Sandrine Bélier, Sergio Berlato, Lajos Bokros, Milan Cabrnoch, Martin Callanan, Nessa Childers, Yves Cochet, Chris Davies, Bas Eickhout, Edite Estrela, Jill Evans, Karl-Heinz Florenz, Elisabetta Gardini, Gerben-Jan Gerbrandy, Matthias Groote, Françoise Grossetête, Cristina Gutiérrez-Cortines, Satu Hassi, Jolanta Emilia Hibner, Karin Kadenbach, Christa Klaß, Eija-Riitta Korhola, Holger Krahmer, Jo Leinen, Corinne Lepage, Peter Liese, Zofija Mazej Kukovič, Linda McAvan, Radvilė Morkūnaitė-Mikulėnienė, Miroslav Ouzký, Vladko Todorov Panayotov, Gilles Pargneaux, Andres Perello Rodriguez, Mario Pirillo, Pavel Poc, Anna Rosbach, Oreste Rossi, Kārlis Šadurskis, Carl Schlyter, Horst Schnellhardt, Richard Seeber, Theodoros Skylakakis, Bogusław Sonik, Salvatore Tatarella, Thomas Ulmer, Sabine Wils
Substitute(s) present for the final vote	Erik Bánki, Adam Gierek, Julie Girling, Esther Herranz García, Rebecca Taylor, Vladimir Urutchev, Anna Záborská, Andrea Zanoni
Date tabled	17.10.2012