Activities of Joanna KOPCIŃSKA related to 2020/0322(COD)
Plenary speeches (2)
European Centre for Disease Prevention and Control - Serious cross-border threats to health (debate)
European Centre for Disease Prevention and Control - Serious cross-border threats to health (debate)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on serious cross-border threats to health repealing Decision No 1082/2013/EU
Amendments (36)
Amendment 108 #
Proposal for a regulation
Recital 2
Recital 2
(2) In light of the lessons learnt during the ongoing COVID-19 pandemic and in order to facilitate adequate Union-wide preparedness and response to all cross- border threats to health, the legal framework for epidemiological surveillance, monitoring, early warning of, and combating serious cross-border threats to health, as set out in Decision No 1082/2013/EU, needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators, and cooperation by Member States with the European Centre for Disease Prevention and Control (ECDC). Moreover, in order to ensure effective Union response to novel cross- border threats to health, the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of EU reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. The capacity for contact tracing should be strengthened via the creation of an automated system, using modern technologies while respecting the data protection rules.
Amendment 122 #
Proposal for a regulation
Recital 6
Recital 6
(6) The protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States, should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the activities of which are relevant to the preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. These mechanisms should look for synergies between measures taken at the EU and national levels, as well as try to avoid duplications with measures undertaken in the context with the WHO framework. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (‘EWRS’) set up by Decision No 2119/98/EC.
Amendment 145 #
Proposal for a regulation
Recital 8
Recital 8
(8) To this end, Member States should provide the Commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. Information provided by the Member States should include the elements that Member States are obliged to report to the World Health Organization (WHO) in the context of the International Health Regulations (IHR)15 . In turn, the Commission should report to the European Parliament and to the Council on the state of play and progress with preparedness, response planning and implementation at Union level, including on corrective actions, every 2 years to ensure that national preparedness and response plans are adequate. In order to support the assessment of these plans, EU audits inevaluations of Member States should be conducted, in coordination with the ECDC and Union agencies. Such planning should include in particular adequate preparedness of critical sectors of society, such as energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. _________________ 15World Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/
Amendment 156 #
Proposal for a regulation
Recital 9
Recital 9
(9) As serious cross-border threats to health are not limited to Union borders, joint procurement of medical countermeasures should be extended to include European Free Trade Association States and Union candidate countries, in accordance with the applicable Union legislation. The Joint Procurement Agreement, determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU, should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the EU to strengthen the negotiating position of the Member States and allow for preferable purchasing conditions concerning the quantity, availability or price of a procured medical countermeasure. The Commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council16 . _________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
Amendment 161 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9 a) Since one of the primary responsibility of the Member States is to ensure the protection of their citizens, additional flexibility is needed when it comes to being able to adjust contractual provisions after the initial contract has been established, in order to increase, decrease or cancel the order for the medical counter measures, taking into account significant changes in circumstances which may occur. In order to protect the contractors directly engaged in activities that serve Union policies, such contractual adjustments should be duly justified by the national authorities participating in the joint procurement procedure, by explaining the seriousness or urgency of the circumstances in question and such adjustments should be enforced in close cooperation with contracted partners and taking due account of the commitments made up to date of contractual adjustment.
Amendment 177 #
Proposal for a regulation
Recital 11
Recital 11
(11) The Commission should strengthen cooperation and activities with the Member States, the ECDC, the European Medicines Agency (‘EMA’), other Union Agencies, research infrastructures and the WHO to improve the prevention of communicable diseases, such as vaccine preventable diseases, as well as other health issues, such as antimicrobial resistance or major non-communicable diseases.
Amendment 222 #
Proposal for a regulation
Article 1 – paragraph 1 – point b – point ii
Article 1 – paragraph 1 – point b – point ii
(ii) reporting and auditingevaluation on preparedness;
Amendment 238 #
Proposal for a regulation
Article 2 – paragraph 4
Article 2 – paragraph 4
4. In exceptional emergency situations, a Member State or the Commission may request the coordination of response within the HSC as referred to in Article 21, for serious cross-border threats to health other than those referred to in Article 2(1), especially in relation to major non-communicable diseases, if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health.
Amendment 239 #
Proposal for a regulation
Article 2 – paragraph 5
Article 2 – paragraph 5
5. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the mechanisms and structures established under this Regulation and similar mechanisms and structures established at international level, Union level or under the Euratom Treaty whose activities are relevant for preparedness and response planning, monitoring, early warning of, and combating serious cross- border threats to health.
Amendment 247 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
(7) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental, climate or unknown origin which spreads or entails a significant risk of coming from third countries to the territories of Member States and/or spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection;
Amendment 250 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7 a (new)
Article 3 – paragraph 1 – point 7 a (new)
(7 a) ‘major non-communicable disease’ means a disease as defined in point (4a) of Article 2 of Regulation (EU) [ECDC regulation, correct reference to be inserted];
Amendment 264 #
Proposal for a regulation
Article 4 – paragraph 2 – subparagraph 1 (new)
Article 4 – paragraph 2 – subparagraph 1 (new)
The relevant Union agencies shall be involved in fulfilling the tasks of the HSC.
Amendment 268 #
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. The HSC shall be chaired by a representative of the Commission without the right to vote. The HSC shall meet at regular intervals and whenever the situation requires, on a request from the Commission or a Member State.
Amendment 284 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The Commission, in cooperation with Member States and the relevant Union agencies and taking into account the WHO framework, shall establish a Union health crisis and pandemic plan (‘the Union preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at Union level.
Amendment 325 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. When preparing national preparedness and response plans each Member State shall coordinate with the Commission in order to reach synergies and consistency withof the Union preparedness and response plan, and national plans and shall also inform without delay the Commission and the HSC of any substantial revision of the national plan.
Amendment 344 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point i
Article 7 – paragraph 1 – subparagraph 1 – point b – point i
(i) governance: including national and, if appropriate, regional policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery; coordination mechanisms;
Amendment 356 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
Article 7 – paragraph 1 – subparagraph 1 – point b – point ii
(ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; access to diagnostic services during emergencies; basic and safe gender- sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 373 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2 a (new)
Article 7 – paragraph 1 – subparagraph 2 a (new)
The report shall also include, as far as feasible, information on major non- communicable diseases as referred to in Article 2 - paragraph 1 - point 4a (new) [ECDC regulation, correct reference to be inserted], in particular those whose developments and treatments are impacted significantly by pandemics, such as cancer, diabetes or mental illness
Amendment 380 #
Proposal for a regulation
Article 8 – title
Article 8 – title
Amendment 382 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Every 3 years, the ECDC shall conduct auditevaluations in the Member States aimed at ascertaining the state of implementation of the national plans and their coherence withsynergies and consistency between them and the Union plan. Such auditevaluations shall be implemenconducted with the relevant Union agencies, aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in Article 7(1).
Amendment 389 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point c
Article 8 – paragraph 2 – subparagraph 1 – point c
(c) overview reports of audits series, which present cases of good practice.
Amendment 390 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 a (new)
Article 8 – paragraph 2 – subparagraph 1 a (new)
If a Member States decides not to follow the recommendation, it shall state reasons for doing so.
Amendment 393 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. On the basis of the information provided by the Member States in accordance with Article 7, and of the results of the auditevaluations referred to in Article 8, the Commission shall by July 2022 and every 2 years afterwards, transmit to the European Parliament and to the Council a report on the state of play and progress on preparedness and response planning at Union level and national levels.
Amendment 404 #
Proposal for a regulation
Article 10 – paragraph 1 – introductory part
Article 10 – paragraph 1 – introductory part
1. The Commission and the Member States shall work together within the HSC to coordinate their efforts to develop, strengthen andor at least maintain their capacities for the monitoring, early warning and assessment of, and response to serious cross-border threats to health.
Amendment 461 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 (new)
Article 12 – paragraph 2 – subparagraph 1 (new)
Member States joining a joint procurement may change the demand expressed earlier, including resignation from participation in the procurement, if there has been a significant change in circumstances resulting from a legitimate public interest.
Amendment 503 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The ECDC shall ensure the furthercontinuous development of the digital platform through which data are managed and automatically exchanged, to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, based on a data protection impact assessment (DPIA) to be conducted prior to their deployment, for the purpose of supporting communicable disease prevention and control.
Amendment 535 #
Proposal for a regulation
Article 16 – paragraph 3
Article 16 – paragraph 3
3. Each Member States willing to participate shall designate the competent authorities responsible within their territory for the services supporting transfusion, transplantation and medically assisted reproduction as referred to in paragraph 1. If the participation in the network is made mandatory in accordance with Articles 5(8) and 31 of the [ECDC Regulation], this obligation shall be extended to each Member State.
Amendment 563 #
Proposal for a regulation
Article 19 – paragraph 3 – point f
Article 19 – paragraph 3 – point f
(f) public health risks, to the extent feasible including impacts on the major con-communicable diseases;
Amendment 573 #
Proposal for a regulation
Article 20 – paragraph 1 – point a
Article 20 – paragraph 1 – point a
(a) the ECDC in accordance with Article 8a of Regulation (EU) …/… [OJ: Please insert the number of Regulation ECDC [ISC/2020/ 12527]] in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1) including substances of human origin: blood, organs, tissues and cells potentially impacted by communicable diseases; or point (d) of Article 2(1); and/or
Amendment 590 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – 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, inform and consult the other Member States, in particular neighbouring Member States, and the Commission on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary.
Amendment 605 #
Proposal for a regulation
Article 23 – paragraph 3
Article 23 – paragraph 3
3. Before recognising a situation of public health emergency at Union level, the Commission shouldall liaise with the WHO in order to share the Commission’s analysis of the situation of the outbreak and to inform the WHO of its intention to adopt such a decision.
Amendment 607 #
Proposal for a regulation
Article 23 – paragraph 4 – subparagraph 1
Article 23 – paragraph 4 – subparagraph 1
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(23).
Amendment 608 #
Proposal for a regulation
Article 23 – paragraph 4 – subparagraph 2
Article 23 – paragraph 4 – subparagraph 2
Amendment 617 #
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The Advisory Committee shall be composed of independent experts, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. Member States may propose experts to the Commission. The Committee shouldall have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, cultural and international aspects and shall, as far as possible, respect the geographical balance of the Union. The representatives of the ECDC and of the EMA shall participate as observers in the Advisory Committee. The representatives of other Union bodies or agencies relevant to the specific threat shall participate as observers in this Committee as necessary. The Commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the Advisory Committee on an ad- hoc basis.
Amendment 642 #
Proposal for a regulation
Article 29 – paragraph 1
Article 29 – paragraph 1
By 2025… [please insert date five years after the date of entry into force of this Regulation], and every 5 years thereafter the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council. The evaluation shall be conducted in accordance with the Commission’s better regulation guidelines. The evaluation shall include, in particular, an assessment of the operation of the EWRS and the epidemiological surveillance network, as well as the coordination of the response with the HSC.
Amendment 643 #
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
Based on the evaluation referred to in the previous subparagraph, the Commission shall, where appropriate, submit a legislative proposal to amend this Regulation.