60 Amendments of Stanislav POLČÁK related to 2020/0322(COD)
Amendment 134 #
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 HSCealth Security Committee (HSC). The abbreviation is used for the first reference and is not clear. 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 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 144 #
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, 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/Does not affect the English version.)
Amendment 195 #
Proposal for a regulation
Recital 16
Recital 16
(16) To this effect, the HSC responsible for the coordination of response at Union level, should assume additional responsibility for the adoption of opinions and guidancerecommendations for Member States related to the prevention and control of a serious cross border threats to health. Furthermore, should the coordination of national public health measures prove insufficient to ensure an adequate Union response, the Commission should further support Member States via the adoption of recommendations on temporary public health measures.
Amendment 200 #
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 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. Member States, through their representatives, should also be able to participate in the Committee's meetings as observers. Recognition of a public health emergency at Union level will provide the basis for introducing operational public health measures for medical 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 208 #
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 iInternational cooperation agreements should be concluded 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. WSuch agreements would benefit the Union and third countries, and 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 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 233 #
Proposal for a regulation
Article 2 – paragraph 1 – point e
Article 2 – paragraph 1 – point e
(e) events which may constitute public health emergencies of international concern under the International Health Regulations (IHR), provided that they fall under one of the categories of threats set out in points (a) to (d).
Amendment 242 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
Amendment 248 #
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 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;Does not affect the English version.)
Amendment 251 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
Amendment 261 #
Proposal for a regulation
Article 4 – paragraph 2 – point d
Article 4 – paragraph 2 – point d
(d) adoption of opinions and guidance, including on specific response measures for the Member States for the prevention and control of serious cross-border threats to health.Does not affect the English version.)
Amendment 267 #
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. The HSC shall be chaired by a representative of the Commission. The HSC shall meet at regular intervals and who shall have no voting rights. The Health Security Committee shall meet whenever the situation requires, on a request from the Commission or a Member State, as well as outside those intervals.
Amendment 272 #
Proposal for a regulation
Article 4 – paragraph 6 – point b
Article 4 – paragraph 6 – point b
(b) the participation of experts in plenary meetings at high level, the status of possible observers, including from third countries;
Amendment 289 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
2. The Union preparedness and response plan shall complement the national preparedness and response plans established in accordance with Article 6.
Amendment 297 #
Proposal for a regulation
Article 5 – paragraph 3 – point f
Article 5 – paragraph 3 – point f
(f) the health preparedness and response and intersectoral collaboration, including between the health and veterinary sectors in cases of cross-border zoonotic health threats;
Amendment 311 #
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. The Union 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 323 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. WhenMember States shall preparinge national preparedness and response plans for cross-border health threats. When preparing them, each Member State shall 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 331 #
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, within 6 months of the entry into force of this regulation and every 2 years thereafter, provide the Commission with a report on their preparedness and response planning and implementation at national level.
Amendment 339 #
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 on the status of the implementation of the capacity standards for preparedness and response planning as determined at national level for the health sector, as provided to the WHO in accordance with the IHR;Does not affect the English version.)
Amendment 346 #
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 preparedness; plans for emergency preparedness, response and recovery; coordination mechanisms of the competent authorities;
Amendment 353 #
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 that take account of the needs of populations with higher risks; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 362 #
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; logisticsal mechanisms and essential health supplies for health; and dedicated, trained and equipped human resources for emergencies; and
Amendment 383 #
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 in cooperation 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 386 #
Proposal for a regulation
Article 8 – paragraph 2 – introductory part
Article 8 – paragraph 2 – introductory part
2. Should the audit identifies deficiencies, the Member States shall, within six months of receipt of its conclusions, present an action plan addressing the proposed recommendations of the audit and setting out the corresponding corrective actions and milestones.
Amendment 388 #
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 ofcarried out which contain good practices.
Amendment 392 #
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, within 2 years of the entry into force of this regulation 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.
Amendment 408 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point c
Article 10 – paragraph 1 – subparagraph 1 – point c
(c) supporting the implementation of capacity requirements for surveillance and response as referred to in the IHR;Does not affect the English version.)
Amendment 409 #
Proposal for a regulation
Article 10 – paragraph 1 – subparagraph 1 – point d
Article 10 – paragraph 1 – subparagraph 1 – point d
(d) developingsupporting the development of the preparedness plans referred to in Articles 5 and 6;
Amendment 418 #
Proposal for a regulation
Article 11 – paragraph 1 – introductory part
Article 11 – paragraph 1 – introductory part
Amendment 429 #
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, in justified cases, be organised outside the Union.
Amendment 435 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Commission and any Member States which so desire may engage in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council29 with a view to the advance purchase of medicalhealth countermeasures for serious cross-border threats to health. _________________ 29Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
Amendment 484 #
Proposal for a regulation
Article 13 – paragraph 2 – point e
Article 13 – paragraph 2 – point e
(e) contribute to the assessment of the burden of communicable diseases on the population using such data as disease prevalence, complications, the need for hospitalisation and mortality;
Amendment 491 #
Proposal for a regulation
Article 13 – paragraph 3 – introductory part
Article 13 – paragraph 3 – introductory part
3. The national competent authorities referred to in paragraph 1 shall communicatenotify the following information to the participating authorities of the epidemiological surveillance network:
Amendment 492 #
Proposal for a regulation
Article 13 – paragraph 3 – point b
Article 13 – paragraph 3 – point b
(b) relevant information concerning the progression of epidemic situations, including for modelling and scenario development, for response;
Amendment 497 #
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. When reportnotifying information on epidemiological surveillance, the national competent authorities shall, where available, use the case definitions adopted in accordance with paragraph 9 for each communicable disease and related special health issue referred to in paragraph 1.
Amendment 499 #
Proposal for a regulation
Article 13 – paragraph 5
Article 13 – paragraph 5
5. The Commission and the Member States shall work together to define disease-specific European surveillance standards based on the proposal of the ECDC, in consultation with othe relevantr bodies connected to the epidemiological surveillance networks.
Amendment 507 #
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 an integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, for the purpose of supporting communicable disease prevention and control.
Amendment 520 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. In the area of public health or for specific areas of public health relevant for the implementation of this Regulation or of the national plans referred to in Article 6, the Commission may, by means of implementing acts, designate EU reference laboratories to provide support to national reference laboratories to promote good practice and alignment by Member States on a voluntary basis on diagnostics, testing methods, use of certain tests for the uniform surveillance, notification and reporting of diseases by Member States.
Amendment 522 #
Proposal for a regulation
Article 15 – paragraph 2 – introductory part
Article 15 – paragraph 2 – introductory part
2. The EU reference laboratories shall be responsiblefulfil in particular for the following tasks to coordinate the network of national reference laboratories, in particular, in the following areas:
Amendment 527 #
Proposal for a regulation
Article 15 – paragraph 3
Article 15 – paragraph 3
Amendment 530 #
Proposal for a regulation
Article 15 – paragraph 4 – introductory part
Article 15 – paragraph 4 – introductory part
Amendment 531 #
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
Amendment 534 #
Proposal for a regulation
Article 16 – paragraph 2
Article 16 – paragraph 2
2. The network shall be operated and coordinated by the ECDCECDC shall assure and coordinate the operations of the network.
Amendment 547 #
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 applicapplications using satellite navigations, or other technologies for automated contact tracing, building upon the contact tracing technologies developed by the Member States.
Amendment 560 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
Amendment 570 #
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. That risk assessment shall be carried out on their own initiative or at the request of the Commission by:
Amendment 572 #
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:, such as blood, organs, tissues and cells potentially impacted by communicable diseases; or point (d) of Article 2(1); and/or
Amendment 580 #
Proposal for a regulation
Article 21 – paragraph 1 – point a
Article 21 – paragraph 1 – point a
(a) national responses, including research needs, to the serious cross-border threat to health, including where a public health emergency of international concern is declared in accordance with the IHR and falls within Article 2 of this RegulatDoes not affect the English version;.)
Amendment 583 #
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 easy-to- understand, consistent and coordinated information in the Union to the public and to healthcare professionals;
Amendment 585 #
Proposal for a regulation
Article 21 – paragraph 1 – point c
Article 21 – paragraph 1 – point c
(c) adoption of opinions and guidancerecommendations, including on specific response measures for the Member States for the prevention and control of a serious cross-border threat to health.
Amendment 594 #
Proposal for a regulation
Article 21 – paragraph 3
Article 21 – paragraph 3
3. Where a Member State has to immediately 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, immediatedirectly upon adoption, inform the other Member States and the Commission on the nature, purpose and scope of those measures.
Amendment 597 #
Proposal for a regulation
Article 22 – paragraph 2 – point a
Article 22 – paragraph 2 – point a
(a) be based on in particular recommendations of the ECDC in particular, other relevant agencies or bodies, or the Advisory Committee referred to in Article 24;
Amendment 601 #
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 particularmust not create any unnecessary restriction to the free movement of persons, of goods and of services.
Amendment 604 #
Proposal for a regulation
Article 23 – paragraph 2
Article 23 – paragraph 2
2. The Commission shall terminate the recognition referred to in paragraph 1 as soon as one of the applicable conditions laid down therein is no longer metfulfilled.
Amendment 606 #
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 610 #
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 shall establish an, in response to a specific arising threat, an ad hoc Advisory Committee on public health emergencies (‘Advisory Committee’) which, at the request of the Commission, shall advise the Commission by providing its views on:
Amendment 612 #
Proposal for a regulation
Article 24 – paragraph 1 – point b
Article 24 – paragraph 1 – point b
(b) the termination of a public health emergency at Union level; andDoes not affect the English version.)
Amendment 615 #
Proposal for a regulation
Article 24 – paragraph 1 – point c – point iii
Article 24 – paragraph 1 – point c – point iii
(iii) prioritisation of health care, civil protection and other resources as well as support measures to be organised or coordinated at Union level;Does not affect the English version.)
Amendment 622 #
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. The Committee should have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, cultural and international aspects. The representatives of the ECDC, the EMA and of the EMAMember States 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 627 #
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 or a Member State, as well as outside those intervals.
Amendment 628 #
Proposal for a regulation
Article 24 – paragraph 4
Article 24 – paragraph 4
4. The Advisory Committee shall be chaired by a representative of the Commission. The chair shall have no voting rights.