Activities of Kateřina KONEČNÁ related to 2020/0322(COD)
Plenary speeches (1)
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
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on Regulation on serious cross-border threats to health repealing Decision No 1082/2013/EU
Amendments (62)
Amendment 10 #
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 health and zoonotic 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 or animal origin. The capacity for contact tracing should be strengthened via the creation of an automated system, using modern technologies.
Amendment 15 #
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods, which provide for special obligations and tools for monitoring, early warning and combatting specific threats of a cross-border nature. Those measures include, in particular, relevant Union legislation in the area of common safety concerns in public health matters, covering goods such as pharmaceutical products, medical devices and foodstuffs, substances of human or animal origin (blood, tissues and cells, organs), and exposure to ionising radiation.
Amendment 19 #
Proposal for a regulation
Recital 7
Recital 7
(7) Preparedness and response planning are essential elements for effective monitoring, early warning of and combatting serious cross-border threats to health. As such, a Union health crisis and pandemic preparedness plan needs to be established by the Commission and approved by the HSC. This should be coupled with updates to Member States’ preparedness and response plans so as to ensure they are compatible within the regional level structures. To support Member States in this endeavour, targeted interdisciplinary training and knowledge exchange activities for healthcare staff and public health staff should be provided knowledge and necessary skills should be provided by the Commission and Union Agencies. To ensure the putting into operation and the running of these plans, the Commission should conduct stress tests, exercises and in-action and after- action reviews with Member States. These plans should be coordinated, be functional and updated, and have sufficient resources for their operationalisation. Following stress tests and reviews of the plans, corrective actions should be implemented and the Commission should be kept informed of all updates.
Amendment 20 #
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 in 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, agriculture, food-chain, natural resources, 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 55 #
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 WHOTripartite (WHO, OIE, FAO) to improve the prevention of communicable diseases, such as vaccine preventable diseases, as well as other health issues, such as antimicrobial resistance.
Amendment 60 #
Proposal for a regulation
Recital 17
Recital 17
(17) Inconsistent communication with the public and stakeholders such as healthcare professional, public health professionals, e.g., veterinarians can have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators. The coordination of the response within the HSC, assisted by relevant subgroups, should, therefore, encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication, based on holistic, robust and independent evaluation of public health risks, to be adapted to national needs and circumstances. Such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals. Given the cross- sectoral nature of this type of crises, coordination should also be ensured with other relevant constituencies, such as the Veterinary services and the Union Civil Protection Mechanism established by Decision (EU) 2019/420 of the European Parliament and of the Council17 . __________________ 17Decision (EU) 2019/420 of the European Parliament and of the Council of 13 March 2019 amending Decision No 1313/2013/EU on a Union Civil Protection Mechanism (OJ L 77I , 20.3.2019, p. 1).
Amendment 69 #
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24a) National authorities should where appropriate consult and involve in the implementation of this regulation representative national social partners in the healthcare and social services sector.
Amendment 72 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) The recommendations of the World Health Organisation’s High Level Expert Group on Health Employment and Economic Growth (2016)1a to address workforce shortages shall be integrated in the preparedness plans to ensure adequate and needs- oriented staffing level. __________________ 1ahttps://www.who.int/hrh/com- heeg/reports/report-expert-group/en/
Amendment 73 #
Proposal for a regulation
Recital 26 b (new)
Recital 26 b (new)
(26b) The COVID 19 health crisis has shown that neither the joint procurement of medical countermeasures or Union’s funding for research of them have proved to be a sufficient solution to tackle the public health emergency. In the event that a public health emergency is declared at Union level and instruments under this regulation, such as joint procurement of medical countermeasures, will prove that are not sufficient to address the health crisis, the Commission should in the future have the power to grant so-called compulsory licenses on patents on these medicines, vaccines and medical devices to European manufactures to enhance Union production capacity. The Commission and the Member States should consider possible delegation of power to grant compulsory licenses to Commission in the next revision of this Regulation.
Amendment 87 #
Proposal for a regulation
Article 4 – paragraph 7 – subparagraph 1 a (new)
Article 4 – paragraph 7 – subparagraph 1 a (new)
Recognised European social partners in the relevant EU sectoral social dialogue committees in the health and social services shall have an observer status in the HCS.
Amendment 91 #
Proposal for a regulation
Article 5 – paragraph 3 – point g a (new)
Article 5 – paragraph 3 – point g a (new)
(ga) adequate and needs- oriented staffing level;
Amendment 92 #
Proposal for a regulation
Article 5 – paragraph 3 – point g b (new)
Article 5 – paragraph 3 – point g b (new)
(gb) adequate stock of personal protective equipment of the highest quality;
Amendment 93 #
Proposal for a regulation
Article 5 – paragraph 3 – point g c (new)
Article 5 – paragraph 3 – point g c (new)
(gc) monitoring if adequate risk assessments, preparedness plans and trainings are foreseen for the health and social care at the work place level;
Amendment 94 #
Proposal for a regulation
Article 5 – paragraph 3 – point g d (new)
Article 5 – paragraph 3 – point g d (new)
(gd) inclusiveness of the national health systems to ensure equal access to health and social services and to allow for quality treatments without a delay
Amendment 97 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. When preparing national preparedness and response plans each Member State shall consult national social partners and coordinate with the Commission in order to reach consistency with the Union preparedness and response plan, also inform without delay the Commission and the HSC of any substantial revision of the national plan.
Amendment 99 #
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, adequate stock of personal protective equipment of the highest quality;
Amendment 101 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
(iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and adequate needs-oriented number of dedicated, trained and equipped human resources for emergencies in the health and social services; and
Amendment 103 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point c a (new)
Article 7 – paragraph 1 – subparagraph 1 – point c a (new)
(ca) the consultation with social partners that has taken place to ensure risk assessments, preparedness plans and implementation are broadly shared and supported and in line with prevailing labour legislation and collective agreements;
Amendment 106 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point b
Article 8 – paragraph 2 – subparagraph 1 – point b
(b) initiatives in relation to recruitment and retention of healthcare personnel and training initiatives;
Amendment 108 #
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
1. The Commission may organise training activities for healthcare and social service staff and public health staff in the Member States, including preparedness capacities under the International Health Regulations.
Amendment 109 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
The Commission shall organise those activities in cooperation with the Member States concerned. The Commission will consult the relevant European social partners for the health and social care sector on the training activities.
Amendment 129 #
Proposal for a regulation
Recital 7
Recital 7
(7) Prevention, preparedness and response planning are essential elements for effective monitoring, early warning of and combatting serious cross-border threats to health. As such, a Union health crisis and pandemic preparedness plan needs to be established by the Commission and approved by the HSC. This should be coupled with updates to Member States’ prevention, preparedness and response plans so as to ensure they are compatible within the regional level structures. To support Member States in this endeavour, targeted training and knowledge exchange activities for healthcare staff and public health staff should be provided knowledge and necessary skills should be provided by the Commission and Union Agencies. This training should be consistent with the One-Health approach in recognition of the interlinks between human health, animal health and the environment. To ensure the putting into operation and the running of these plans, the Commission should conduct stress tests, exercises and in-action and after-action reviews with Member States. These plans should be coordinated, be functional and updated, and have sufficient resources for their operationalisation. Specific considerations should be given to border regions, where joint cross-border exercises should be promoted and familiarity with the public health system structures encouraged. Following stress tests and reviews of the plans, corrective actions should be implemented and the Commission should be kept informed of all updates.
Amendment 156 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The ECDC shall ensure the further 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, for the purpose of supporting communicable disease prevention and control. The platform should be used with the human in control principle on the artificial intelligence.
Amendment 164 #
Proposal for a regulation
Article 21 – paragraph 1 – point b
Article 21 – paragraph 1 – point b
(b) risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing consistent and coordinated information in the Union to the public and to healthcare professionaland when appropriate to other public health professionals, e.g., veterinarians;
Amendment 214 #
Proposal for a regulation
Recital 25
Recital 25
(25) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt implementing acts in relation to: templates to be used when providing the information on preparedness and response planning; organisation of the training activities for health care and public health staff; the establishment and update of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and, where necessary, for other serious cross- border threats to health subject to ad hoc monitoring; the procedures for the operation of the EWRS; the establishment and updating of a list of relevant health data that the ECDC will have access to pursuant to Article 14(2)(a) and (5) and respective role; the functioning of the surveillance platform; the designation of EU reference laboratories to provide support to national reference laboratories; the procedures for the information exchange on and the coordination of the responses of the Member States; the recognition of situations of public health emergency at Union level and the termination of such a recognition and procedures necessary to ensure that the operation of the EWRS and the processing of data are in accordance with the data protection legislation.
Amendment 217 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25 a) National authorities should where appropriate consult and involve in the implementation of this regulation representatives of patients organisations and national social partners in the healthcare and social services sector.
Amendment 218 #
Proposal for a regulation
Recital 25 b (new)
Recital 25 b (new)
(25 b) The recommendations of the World Health Organization’s High Level Expert Group on Health Employment and Economic Growth1a to address workforce shortages shall be integrated in the prevention, preparedness and respons plans to ensure adequate and needs- oriented staffing level. _________________ 1ahttps://www.who.int/hrh/com- heeg/reports/report-expert-group/en/
Amendment 220 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28 a) The COVID 19 health crisis has shown that neither the joint procurement of medical countermeasures nor Union funding for research into them have proved to be a sufficient solution to tackle the public health emergency. In the event that a public health emergency is declared at Union level and instruments under this regulation, such as joint procurement of medical countermeasures, will prove that are not sufficient to address the health crisis, the Commission should in the future have the power in line with the WTO rules to grant so-called compulsory licenses on patents on these medicines, vaccines and medical devices to Union manufacturers to enhance Union production capacity. Asks the Commission and the Member States to consider the possible delegation of power to grant compulsory licenses to the Commission in the next revision of this Regulation.
Amendment 228 #
Proposal for a regulation
Article 1 – paragraph 3 a (new)
Article 1 – paragraph 3 a (new)
3 a. The implementation of this Regulation shall be with full respect for the dignity and fundamental rights and freedoms of persons.
Amendment 275 #
Proposal for a regulation
Article 4 – paragraph 7 – subparagraph 1 a (new)
Article 4 – paragraph 7 – subparagraph 1 a (new)
Recognised European social partners in the relevant EU sectoral social dialogue committees in the health and social services and the representative of patient's organizations shall have observer status in the HSC.
Amendment 280 #
II PREVENTION, PREPAREDNESS AND RESPONSE PLANNING
Amendment 285 #
Proposal for a regulation
Article 5 – paragraph 1
Article 5 – paragraph 1
Amendment 288 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. The Union prevention, preparedness and response plan shall complement the national preparedness and response plans established in accordance with Article 6.
Amendment 290 #
Proposal for a regulation
Article 5 – paragraph 3 – introductory part
Article 5 – paragraph 3 – introductory part
3. The Union prevention, preparedness and response plan shall, in particular, include arrangements for governance, capacities and resources for:
Amendment 300 #
Proposal for a regulation
Article 5 – paragraph 3 – point g a (new)
Article 5 – paragraph 3 – point g a (new)
(g a) adequate and needs-oriented staffing level;
Amendment 301 #
Proposal for a regulation
Article 5 – paragraph 3 – point g b (new)
Article 5 – paragraph 3 – point g b (new)
(g b) adequate stock of personal protective equipment of the highest quality;
Amendment 303 #
Proposal for a regulation
Article 5 – paragraph 3 – point g c (new)
Article 5 – paragraph 3 – point g c (new)
(g c) monitoring if adequate risk assessments, preparedness plans and trainings are foreseen for the health and social care at the workplace level;
Amendment 304 #
Proposal for a regulation
Article 5 – paragraph 3 – point g d (new)
Article 5 – paragraph 3 – point g d (new)
(g d) inclusiveness of the national health systems to ensure equal access to health and social services and to allow for quality treatments without a delay.
Amendment 309 #
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The Union prevention, preparedness and response plan shall include interregional preparedness elements to establish coherent, multi-sectoral, cross-border public health measures, in particular considering capacities for testing, contact tracing, laboratories, and specialised treatment or intensive care across neighbouring regions. The plans shall include preparedness and response means to address the situation of those citizens with higher risks.
Amendment 312 #
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. In order to ensure the operation of the Union preparedness and response plan, the Commission shall conduct stress tests, exercises and in-action and after-action reviews with Member States, and update the plan as necessary. The prevention, preparedness and response plan will take into account health systems data and relevant data to be collected at national level. Based on EU health systems data, the European Commission should issue recommendations as to ratios of resources in relation to population unit for baseline universal health coverage and emergencies, including the option of pooling resources at Union level.
Amendment 318 #
Proposal for a regulation
Article 6 – title
Article 6 – title
National prevention, preparedness and response plans
Amendment 321 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. When preparing national prevention, preparedness and response plans each Member State shall consult patient's organizations, healthcare professionals organizations and national social partners and coordinate with the Commission in order to reach consistency with the Union prevention, preparedness and response plan, also inform without delay the Commission and the HSC of any substantial revision of the national plan.
Amendment 328 #
Proposal for a regulation
Article 7 – title
Article 7 – title
Reporting on prevention, preparedness and response planning
Amendment 334 #
Proposal for a regulation
Article 7 – paragraph 1 – introductory part
Article 7 – paragraph 1 – introductory part
1. Member States shall by the end of November 2021 and every 2 years thereafter provide the Commission with a report on their prevention, preparedness and response planning and implementation at national level.
Amendment 351 #
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, adequate stock of personal protective equipment of the highest quality;
Amendment 358 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
Article 7 – paragraph 1 – subparagraph 1 – point b – point iii
(iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and adequate needs-oriented number of dedicated, trained and equipped human resources for emergencies in the health and social services ; and
Amendment 366 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point c a (new)
Article 7 – paragraph 1 – subparagraph 1 – point c a (new)
(c a) the consultation with social partners that has taken place to ensure risk assessments, prevention, preparedness and response plans and implementation are broadly shared and supported and in line with prevailing labour legislation and collective agreements;
Amendment 372 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2
Article 7 – paragraph 1 – subparagraph 2
The report shall include, whenever relevant, interregional prevention, preparedness and response elements in line with the Union and national plans, covering in particular the existing capacities, resources and coordination mechanisms across neighbouring regions.
Amendment 379 #
Proposal for a regulation
Article 8 – title
Article 8 – title
Auditing on prevention, preparedness and response planning
Amendment 385 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Every 3 years, the ECDC shall conduct audits in the Member States aimed at ascertaining the state of implementation of the national plans and their coherence with the Union plan. Such audits shall be implemented with the relevant Union agencies, aiming at the assessment of prevention, preparedness and response planning at national level with regard to the information referred to in Article 7(1).
Amendment 387 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1 – point b
Article 8 – paragraph 2 – subparagraph 1 – point b
(b) initiatives in relation to recruitment and retention of healthcare personnel and training initiatives;
Amendment 391 #
Proposal for a regulation
Article 9 – title
Article 9 – title
Commission report on prevention, preparedness planning
Amendment 394 #
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 audits 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 prevention, preparedness and response planning at Union level.
Amendment 398 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission may adopt recommendations on preparedness and response planning addressed to Member States based on the report referred to in paragraph 1.These recommendations shall include ratios for resources per population unit, developed on the basis of good practice and policy assessments.
Amendment 399 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission may adopt recommendations on prevention, preparedness and response planning addressed to Member States based on the report referred to in paragraph 1.
Amendment 400 #
Coordination of prevention, preparedness and response planning in the HSC
Amendment 411 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point e
Article 10 – paragraph 1 – subparagraph 1 – point e
(e) monitoring progress, identifying gaps and actions to strengthen prevention, preparedness and response planning, including in the field of research, at national and at Union levels.
Amendment 417 #
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
1. The Commission may organise training activities for healthcare and social service staff and public health staff in the Member States, including preparedness capacities under the International Health Regulations.
Amendment 421 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1
Article 11 – paragraph 1 – subparagraph 1
The Commission shall organise those activities in cooperation with the Member States concerned. At border regions, joint cross-border exercises should be promoted and familiarity with public health systems encouraged.
Amendment 428 #
Proposal for a regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
3. The training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may be organised outside the Union in coordination with ECDC activities in this area.
Amendment 506 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. The ECDC shall ensure the further 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, for the purpose of supporting communicable disease prevention and control. Human oversight should be ensured.
Amendment 526 #
Proposal for a regulation
Article 15 – paragraph 3
Article 15 – paragraph 3
3. The network of EU reference laboratories shall be operated and coordinated by the ECDC in cooperation with WHO network laboratories to avoid duplication of activities.