95 Amendments of Monika BEŇOVÁ related to 2020/0322(COD)
Amendment 109 #
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 prevention, 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.
Amendment 113 #
Proposal for a regulation
Recital 3
Recital 3
(3) An important role in the coordination of prevention, preparedness and response planning for serious cross- border threats to health is being played by the Health Security Committee (HSC), as formally established by Decision No 1082/2013/EU. This Committee should be given additional responsibilities with regard to the adoption of guidance and opinions to better support Member States in the prevention and control of serious cross-border threats to health and support better coordination between Member States to address these threats.
Amendment 117 #
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, such as the International Health Regulations (IHR) of the World Health Organization (WHO) amongst others. 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 origin (blood, tissues and cells, organs), and exposure to ionising radiation.
Amendment 124 #
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 and should ensure a “One Health” and “Health in all policies” approach. 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. 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 130 #
Proposal for a regulation
Recital 7
Recital 7
(7) Preventing, 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. This exercise should be consistent with the One-Health approach in recognition of the interlinks between human health, animal health and the environment. 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. 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 143 #
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 prevention, 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 prevention, 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, 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 147 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8 a) Health literacy plays a fundamental role in preventing and mitigating the impact of cross-borders threats and contributing to a better understanding by the population of the countermeasures and risk assessment of different threats. Respiratory etiquette, correct hand washing, avoiding unnecessary close contact with anyone with flu-like symptoms, and avoiding unprotected contact with wild animals should be part of health education campaigns to improve the population's behaviour, based on the latest available evidence.
Amendment 182 #
Proposal for a regulation
Recital 12
Recital 12
(12) In case of cross-border health threats due to a communicable disease, the blood and transplant services in the Member States can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. These services in return are dependent on rapid risk assessments by the ECDC to safeguard patients, in need of a therapy from a substance of human origin or under a process of medically assisted reproduction, from a transmission of such communicable disease. Such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. The ECDC should therefore set up and operate a network of national blood and transplant services and their authorities to serve this dual purpose.
Amendment 186 #
Proposal for a regulation
Recital 13
Recital 13
(13) A system enabling the notification at Union level of alerts related to serious cross-border threats to health has been put in place by Decision No 2119/98/EC in order to ensure that competent public health authorities in Member States and the Commission are duly informed in a timely manner. All serious cross-border threats to health covered by this Regulation are covered by the EWRS. The operation of the EWRS should remain within the remit of the ECDC. The notification of an alert should be required only where the scale and severity of the threat concerned are or could become so significant that they affect or could affect more than one Member State and require or could require a coordinated response at the Union level. To avoid duplication and ensure coordination across Union alert systems, the Commission and ECDC should ensure that alert notifications under the EWRS and other rapid alert systems at Union level are automatically linked to each other to the extent possible so that the competent authorities of the Member States can avoid as much as possible notifying the same alert through different systems at Union level and can benefit from receiving all- hazard alerts from a single coordinated source.
Amendment 203 #
Proposal for a regulation
Recital 18
Recital 18
(18) The recognition of public health emergency situations and the legal effects of this recognition provided by Decision No 1082/2013/EU should be broadened. To this end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level. In order to recognise such an emergency situation, the Commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of this emergency recognition. The advisory committee should consist of independent experts, selected by the Commission, after consulting the Health Security Committee, from the fields of expertise and experience most relevant to the specific threat that is occurring, representatives of the ECDC, of the EMA, and of other Union bodies or agencies as observers. Recognition of a public health emergency at Union level will provide the basis for introducing operational public health measures for medicinal products and medical devices, flexible mechanisms to develop, procure, manage and deploy medical countermeasures as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’.
Amendment 206 #
(20) The occurrence of an event that corresponds to serious cross-border threats to health and is likely to have Union-wide consequences should require the Member States concerned to take particular control or contact-tracing measures in a coordinated manner in order to identify people already contaminated and those persons exposed to risk. Such cooperation could require the exchange of personal data through the system, including sensitive information related to health and information about confirmed or suspected human cases of the disease or infection, between those Member States directly involved in the contact-tracing measures. The exchange of personal data concerning health by the Member States has to comply with Article 9(2)(i) of Regulation (EU) 2016/679 of the European Parliament and of the Council18 . _________________ 18Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
Amendment 207 #
Proposal for a regulation
Recital 21
Recital 21
(21) Cooperation with third countries and international organisations in the field of public health should be fostered. It is particularly important to ensure the exchange of information with the WHO on the measures taken pursuant to this Regulation. This reinforced cooperation is also required to contribute to EU’s commitment to strengthening support to health systems and reinforcing partners’ preparedness and response capacity. The Union could benefit from concluding international cooperation agreements with third countries or international organisations, including the WHO, to foster the exchange of relevant information from monitoring and alerting systems on serious cross-border threats to health. Within the limits of the Union’s competences, such agreements could include, where appropriate, the participation of such third countries or international organisations in the relevant epidemiological surveillance monitoring network, such as the European Surveillance System (TESSy), and the EWRS, exchange of good practice in the areas of preparedness and response capacity and planning, public health risk- assessment and collaboration on response coordination, including the research response.
Amendment 212 #
Proposal for a regulation
Recital 22
Recital 22
(22) The processing of personal data for the purpose of implementing this Regulation should comply with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of the European Parliament and of the Council19 . In particular, the operation of the EWRS should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by Member States at national level. In this regard, the EWRS includes a messaging function in which personal data, including contact and health data, can be communicated to relevant authorities involved in contact tracing measures. _________________ 19Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
Amendment 215 #
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 update of a list of relevant health data to be automatically collected by digital platform; 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 226 #
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 carried out in full respect for the dignity and fundamental rights and freedoms of persons and shall ensure the “One health” and “Health in all Policies” approaches.
Amendment 229 #
Proposal for a regulation
Article 2 – paragraph 1 – point a – point i
Article 2 – paragraph 1 – point a – point i
(i) communicable diseases, including communicable diseases of zoonotic origin;
Amendment 237 #
Proposal for a regulation
Article 2 – paragraph 3 a (new)
Article 2 – paragraph 3 a (new)
3 a. This Regulation shall promote the implementation of the International Health Regulation, reduce administrative burden and duplication of resources, and strengthen the gaps unveiled from the COVID-19 pandemic in prevention, preparedness and response to public health threats.
Amendment 244 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) ‘contact tracing’ means measures implemented in order to trace persons who have been exposed to a source of a serious cross-border threat to health, and who are in danger of developingbeing infected, being infectious or have developed a disease, through manual or other technological means;
Amendment 258 #
Proposal for a regulation
Article 4 – paragraph 2 – point b
Article 4 – paragraph 2 – point b
(b) coordination in liaison with the Commission of the prevention, preparedness and response planning of the Member States in accordance with Article 10;
Amendment 278 #
Proposal for a regulation
Article 4 – paragraph 7 a (new)
Article 4 – paragraph 7 a (new)
7 a. The European Parliament shall designate representatives to participate in the Health Security Committee (HSC) as observers.
Amendment 282 #
Proposal for a regulation
Chapter II – title
Chapter II – title
II PREVENTION, PREPAREDNESS AND RESPONSE PLANNING
Amendment 283 #
Proposal for a regulation
Article 5 – title
Article 5 – title
Union prevention, preparedness and response plan
Amendment 286 #
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, shall establish a Union health crisis and pandemic plan (‘the Union prevention, preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at Union level.
Amendment 296 #
Proposal for a regulation
Article 5 – paragraph 3 – point e
Article 5 – paragraph 3 – point e
(e) the risk and crisis communication, for health professionals and for citizens;
Amendment 299 #
Proposal for a regulation
Article 5 – paragraph 3 – point g a (new)
Article 5 – paragraph 3 – point g a (new)
(g a) the continuity of healthcare services, particularly for chronic conditions;
Amendment 302 #
Proposal for a regulation
Article 5 – paragraph 3 – point g b (new)
Article 5 – paragraph 3 – point g b (new)
(g b) the criteria to activate and deactivate the plan.
Amendment 310 #
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 313 #
Proposal for a regulation
Article 5 – paragraph 5
Article 5 – paragraph 5
5. In order to ensure the operation of the Union prevention, 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 or regional level.
Amendment 314 #
Proposal for a regulation
Article 5 – paragraph 5 a (new)
Article 5 – paragraph 5 a (new)
Amendment 315 #
Proposal for a regulation
Article 5 – paragraph 5 b (new)
Article 5 – paragraph 5 b (new)
5 b. The reviews and the following corrective actions shall be published to increase the transparency of the process of prevention, preparedness and response plans.
Amendment 317 #
Proposal for a regulation
Article 6 – title
Article 6 – title
National prevention, preparedness and response plans
Amendment 326 #
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 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 327 #
Proposal for a regulation
Article 6 – paragraph 1 a (new)
Article 6 – paragraph 1 a (new)
1 a. National prevention, preparedness and response plans shall include arrangements for governance, capacities and resources referred to in Article 5(3).
Amendment 329 #
Proposal for a regulation
Article 7 – title
Article 7 – title
Reporting on prevention, preparedness and response planning
Amendment 332 #
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 an updated report on their prevention, preparedness and response planning and implementation at national and regional levels.
Amendment 335 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – introductory part
Article 7 – paragraph 1 – subparagraph 1 – introductory part
That report shall be succinct and give an overview of the actions implemented in the Member States, and shall cover the following:
Amendment 337 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point a
Article 7 – paragraph 1 – subparagraph 1 – point a
(a) identification of, and update, where necessary, on the status of the implementation of the capacity standards for prevent, preparedness and response planning as determined at national level for the health sector, as provided to the WHO in accordance with the IHR;
Amendment 340 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 1 – point b – introductory part
Article 7 – paragraph 1 – subparagraph 1 – point b – introductory part
(b) an update, if needed, on the elements of emergency prevention, preparedness and response, in particular:
Amendment 345 #
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 policies and legislation that integrate emergency prevention and preparedness; plans for emergency prevention, preparedness, response and recovery; coordination mechanisms;
Amendment 355 #
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; equitable access to diagnostic services during emergencies; equitable, quality, basic and safe gender- sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness and response;
Amendment 367 #
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) update, if needed, on the gaps found in the implementation and the corrective actions that will be taken by the Member States to improve their preparedness and response capacity.
Amendment 370 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2
Article 7 – paragraph 1 – subparagraph 2
The report shall include, whenever relevant, interregional and intersectorial 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 374 #
Proposal for a regulation
Article 7 – paragraph 1 – subparagraph 2 a (new)
Article 7 – paragraph 1 – subparagraph 2 a (new)
The latest available version of the prevention, preparedness and response plan shall be attached to the report.
Amendment 378 #
Proposal for a regulation
Article 8 – title
Article 8 – title
Auditing on prevention, preparedness and response planning
Amendment 395 #
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 397 #
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 recommendations on the minimum resources needed in relation to population size, developed on the basis of good practice and policy assessments.
Amendment 401 #
Proposal for a regulation
Article 10 – title
Article 10 – title
Coordination of prevention, preparedness and response planning in the HSC
Amendment 403 #
1. The Commission and the Member States shall work together within the HSC to coordinate their efforts to develop, strengthen and maintain their capacities for the monitoring, prevention, early warning, and assessment of, and response to serious cross-border threats to health.
Amendment 405 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point a
Article 10 – paragraph 1 – subparagraph 1 – point a
(a) sharing best practice and experience in prevention, preparedness and response planning;
Amendment 406 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point b
Article 10 – paragraph 1 – subparagraph 1 – point b
(b) promoting the interoperability of national prevention, preparedness planning and the intersectoral dimension of prevention, preparedness and response planning at Union level;
Amendment 410 #
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 regional, national and at Union levels.
Amendment 415 #
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
1. The Commission may organise training activities, supported by the Union agencies including ECDC, EMA among others, in close cooperation with medical societies and patient organisations, for healthcare staff and public health staff in the Member States in particular interdisciplinary One Health training, including preparedness capacities under the International Health Regulations.
Amendment 419 #
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 and in articulation with WHO to avoid duplication of activities, including preparedness capacities under the International Health Regulations. At border regions, joint cross-border exercises should be promoted and familiarity with public health systems encouraged.
Amendment 422 #
Proposal for a regulation
Article 11 – paragraph 1 – subparagraph 1 a (new)
Article 11 – paragraph 1 – subparagraph 1 a (new)
The Commission shall use the fullest potential of distance learning to broaden the number of trainees.
Amendment 425 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. The training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national preparedness plans referred to in Article 6, implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools and consistent with the One- Health approach.
Amendment 427 #
Proposal for a regulation
Article 11 – paragraph 2 a (new)
Article 11 – paragraph 2 a (new)
2 a. The knowledge and skills referred to in paragraph 2 should be updated every 3 years at the latest, with activities, including laboratory staff training, that fit the needs of healthcare staff and public health staff.
Amendment 475 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. The network for the epidemiological surveillance of the communicable diseases, including communicable diseases of zoonotic origin, and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1) shall ensure a permanent communication between the Commission, the ECDC, and the competent authorities responsible at national level for epidemiological surveillance.
Amendment 481 #
Proposal for a regulation
Article 13 – paragraph 2 – point d
Article 13 – paragraph 2 – point d
(d) identify and monitor risk factors for disease transmission, population groups at risk and in need of targeted prevention measures;
Amendment 488 #
Proposal for a regulation
Article 13 – paragraph 2 – point i a (new)
Article 13 – paragraph 2 – point i a (new)
Amendment 495 #
Proposal for a regulation
Article 13 – paragraph 3 a (new)
Article 13 – paragraph 3 a (new)
3 a. The information communicated by Member States referred to in point (a) shall be reported at least at NUTS II level to the European Surveillance System (TESSy) or another platform, on a timely basis defined by the article 9.
Amendment 500 #
Proposal for a regulation
Article 13 – paragraph 6 – subparagraph 1 a (new)
Article 13 – paragraph 6 – subparagraph 1 a (new)
The ECDC shall support the Member States to ensure the integrated operation of the network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1).
Amendment 501 #
Proposal for a regulation
Article 13 – paragraph 9 – introductory part
Article 13 – paragraph 9 – introductory part
9. The Commission shall, after consulting with the ECDC, by means of implementing acts, establish and update:
Amendment 505 #
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 508 #
Proposal for a regulation
Article 14 – paragraph 2 – point a
Article 14 – paragraph 2 – point a
(a) enable the automated collection of surveillance and laboratory data, make use of informationrelevant health data from a previously defined and authorized list from the electronic health records and health databases, media monitoring, and apply artificial intelligence for data validation, analysis and automated reporting;
Amendment 512 #
Proposal for a regulation
Article 14 – paragraph 2 – point b a (new)
Article 14 – paragraph 2 – point b a (new)
(b a) allow for automated notification on EWRS when communicable diseases rise above warning thresholds, as referred to in point (a) of article 13(2). The notification shall be validated by the competent health authority.
Amendment 513 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Member States are responsible for ensuring that the integrated surveillance system is fed on a regular basis with timely and complete information, data and documents transmitted and exchanged through the digital platform. The Member States shall promote the automation of this process between the national and the Union surveillance system.
Amendment 514 #
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
5. For epidemiological surveillance purposes, ECDC shall also have access to relevant health data accessed or made available through digital infrastructures enabling the use of health data for research, policy making and regulatory purposes. The access to the health data should be proportionate to specific and concrete purposes that shall be defined previously by ECDC.
Amendment 515 #
Proposal for a regulation
Article 14 – paragraph 6 – point c
Article 14 – paragraph 6 – point c
(c) contingency arrangements and secure data backups to be applied in the event of unavailability of any of the functionalities of the platform;
Amendment 516 #
Proposal for a regulation
Article 14 – paragraph 6 – point f a (new)
Article 14 – paragraph 6 – point f a (new)
(f a) Ensure standardization of the infrastructure on storage, processing and analysis of data.
Amendment 528 #
Proposal for a regulation
Article 15 – paragraph 3 a (new)
Article 15 – paragraph 3 a (new)
3 a. The laboratories referred to in paragraph 1 should contribute to share good practices and to improve the epidemiological surveillance referred to in article 13;
Amendment 537 #
Proposal for a regulation
Article 16 – paragraph 3 a (new)
Article 16 – paragraph 3 a (new)
3 a. The sero-epidemiological data referred to in paragraph 1 shall be reported automatically to the national surveillance platforms, contributing to robust the monitoring and epidemiological surveillance of communicable diseases and related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1);
Amendment 538 #
Proposal for a regulation
Article 16 – paragraph 3 b (new)
Article 16 – paragraph 3 b (new)
3 b. The network shall establish Union common standards for transfusion, transplantation and medically assisted reproduction services.
Amendment 541 #
Proposal for a regulation
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
1 a. The European Surveillance System (TESSy) shall be used for ad hoc monitoring of a serious cross-border threat to health referred to in point (iii) of point (a) of Article 2(1) and in points (b), (c) or (d) of Article 2(1).
Amendment 542 #
Proposal for a regulation
Article 17 – paragraph 3 – introductory part
Article 17 – paragraph 3 – introductory part
3. The Commission, after consulting the ECDC shall, by means of implementing acts, adopt, where necessary, the case definitions to be used for ad hoc monitoring, in order to ensure the comparability and compatibility at Union level of the collected data.
Amendment 544 #
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. The EWRS shall enable the Commission, the ECDC, and the competent authorities responsible at national level to be in permanent communication for the purposes of preparedness, early warning and response, alerting, assessing public health risks and determining the measures that may be required to protect public health.
Amendment 548 #
Proposal for a regulation
Article 18 – paragraph 2 – subparagraph 1
Article 18 – paragraph 2 – subparagraph 1
The ECDC shall continuously update the EWRS allowing for the use of modern technologies, such as digital mobile applications, artificial intelligence models, space enabled applications, or other technologies for automated contact tracing, building upon the contact tracing technologies developed by the Member States or by the Union.
Amendment 552 #
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Article 18 – paragraph 2 a (new)
2 a. The ECDC shall develop and improve the EWRS, to augment the automation of information collection and analyses, upgrade the categorization of notification and reduce the open text communication, reduce the administrative burden and improve the standardization of the notifications.
Amendment 553 #
Proposal for a regulation
Article 18 – paragraph 2 b (new)
Article 18 – paragraph 2 b (new)
2 b. The EWRS shall be improved to reduce the burden of bureaucracy and duplications of notification and shall allow the national competent authorities notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR and take up this information in the EWRS system, to automatically notify an alert in the EWRS.
Amendment 555 #
Proposal for a regulation
Article 18 – paragraph 4 a (new)
Article 18 – paragraph 4 a (new)
4 a. The EWRS shall be able to automatically collect information from other important databases such as environmental data, climate data, water irrigation data and other data relevant to the serious cross-border threat to health that could facilitate understanding and mitigate the risk of potential health threats.
Amendment 558 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Where the national competent authorities notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR, they shall at the latestas referred to in point 2b, Article 18, shall be simultaneously notify an alert in the EWRS, provided that the threat concerned falls within those referred to in Article 2(1) of this Regulation.
Amendment 568 #
Proposal for a regulation
Article 19 – paragraph 4 a (new)
Article 19 – paragraph 4 a (new)
4 a. The Member State shall update the information referred to in paragraph 3 as new data becames available.
Amendment 569 #
Proposal for a regulation
Article 20 – paragraph 1 – introductory part
Article 20 – paragraph 1 – introductory part
1. Where an alert is notified pursuant to Article 19, the Commission shall, where necessary for the coordination of the response at Union level or upon request of the HSC referred to in Article 21 or on its own initiative, make promptly available to the national competent authorities and to the HSC, through the EWRS, a risk assessment of the potential severity of the threat to public health, including possible public health measures, including a risk assessment of mental health of the affected population. That risk assessment shall be carried out by:
Amendment 574 #
Proposal for a regulation
Article 20 – paragraph 1 – point a a (new)
Article 20 – paragraph 1 – point a a (new)
(a a) the European Medicines Agency (EMA), in accordance with Article 1 of Regulation (EU) 2021/... [insert the number of revised EMA regulation 2020/0321(COD)], in the case of a shortage of medical products for human use or medical devices that potentially represents a risk to public health.
Amendment 582 #
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 professionals and public health professionals;
Amendment 584 #
Proposal for a regulation
Article 21 – paragraph 1 – point c
Article 21 – paragraph 1 – point c
(c) adoption of opinions and guidance, including on specific response measures for the Member States for the prevention and control of a serious cross-border threat to health, including coordination of response measures.
Amendment 589 #
Proposal for a regulation
Article 21 – paragraph 2
Article 21 – paragraph 2
2. Where a Member State intends to adopt or cease public health measures to combat a serious cross-border threat to health, it shall, before adopting or ceasing those measures, inform and consult, consult and coordinate with the other Member States and, the Commission and Health Security Committee 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 591 #
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and, the Commission and the Health Security Committee on the nature, purpose and scope of those measures.
Amendment 600 #
Proposal for a regulation
Article 22 – paragraph 2 – point c
Article 22 – paragraph 2 – point c
(c) be proportionate to the public health risks related to the threat in question, avoiding in particular any unnecessary restriction to the free movement of persons, of goods and of services, and promote coordination of measures between Member States.
Amendment 603 #
(c a) be time limited, and cease as soon as one of the applicable conditions of (a), (b) and (c) is no longer met.
Amendment 609 #
Proposal for a regulation
Article 24 – paragraph 1 – introductory part
Article 24 – paragraph 1 – introductory part
1. For the purpose of the formal recognition of a public health emergency at Union level, the Commission, with the consultation of the Health Security Committee shall establish an Advisory Committee on public health emergencies (‘Advisory Committee’) which, at the request of the Commission, shall advise the Commission or the Health Security Committee, shall advise the Commission and the Health Security Committee by providing its views on:
Amendment 618 #
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, after consulting the Health Security Committee, according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, cultural, transports and international aspects. The representatives of the ECDC and of the EMA 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 or the Health Security Committee 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 626 #
Proposal for a regulation
Article 24 – paragraph 3
Article 24 – paragraph 3
3. The Advisory Committee shall meet whenever the situation requires, on a request from the Commission, the Health Security Committee or a Member State.
Amendment 629 #
Proposal for a regulation
Article 24 – paragraph 6
Article 24 – paragraph 6
6. The Advisory Committee shall establish its rules of procedure including on the rules for the declaration and termination of an emergency situation, and adoption of recommendations and voting. The rules of procedures shall enter into force after receiving a favourable opinion from the Commission and the Health Security Committee.
Amendment 638 #
Proposal for a regulation
Article 26 – paragraph 6 – point b
Article 26 – paragraph 6 – point b
(b) procedures for the interlinking of the EWRS with contact tracing systems at Union level and international level;
Amendment 640 #
Proposal for a regulation
Article 26 – paragraph 6 – point c a (new)
Article 26 – paragraph 6 – point c a (new)
(c a) the establishment and update of a list of relevant health data to be automatically collected by digital platforms.