49 Amendments of Lídia PEREIRA related to 2020/0320(COD)
Amendment 64 #
Proposal for a regulation
Recital 1
Recital 1
(1) The Union is committed to protect and improve human health, in particular to combat the major cross-border health scourges, measures concerning monitoring, early warning of and combating serious cross-border threats to health with significant social impact throughout the Union.
Amendment 66 #
Proposal for a regulation
Recital 3
Recital 3
(3) On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus COVID-19 outbreak a global pandemic. From the challenges experienced in responding to the pandemic it became clear that the Centre’, which has particularly affected people with chronic non- communicable diseases being more vulnerable to COVID-19 infection. Given the unprecedented challenges experienced in responding to the pandemic and in view of the effectiveness gaps which have been identified in the Centre's performance in that regard, it became clear that its role in the Union’s framework for health crisis preparedness and response should be strengthened to better use the potential of the Union's and Member States' capacities to respond to future pandemics.
Amendment 74 #
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation accordingly expands the mission and tasks of the Centre to enhance the Centre’s capacity to provide the required scientific expertise and to support actions which are relevant to the prevention, preparedness, response planning and combating serious cross- border threats to health in the Union, including cross-border threats, communicable diseases and major chronic diseases and especially the interconnections between them, in accordance with Regulation EU …/… of the European Parliament and of the Council10 [ISC/2020/12524]. __________________ 10Regulation (EU) XXXX/XXXX of the European Parliament and of the Council of DATE on serious cross-border threats to health and repealing Decision No 1082/2013/EU [OJ: please, insert full title and publication reference to Regulation on serious cross border threats to health (SCBTH).]
Amendment 76 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) The European Ombudsman's decision of 5 February2021 in strategic inquiry OI/3/2020/TE identified some important effectiveness gaps in the Centre's response to the COVID-19 pandemic, as regards how the Centre gathers information, the transparency of that information and how it communicates with the public, as well as a power asymmetry between the Centre and the Member States, resulting in lack of timely, complete and comparable data and thus affecting the modelling and forecasting potential of the Centre, which should be addressed in this Regulation.
Amendment 80 #
Proposal for a regulation
Recital 6
Recital 6
(6) In this respect, the Centre should be tasked with providing epidemiological information and its analysis, epidemiological modelling, anticipation and forecasting, relevant risk assessments and recommendations, which set out options for prevention and control of communicable diseases, prevention of excess mortality among patients, notably those suffering from chronic diseases and the increase of infection-caused chronic diseases and other pathogens associated with chronic diseases. This should also contribute to efficiently responding to current and emerging threats to human health posed by non-communicable diseases, either directly or indirectly, due to increasing risks associated with communicable diseases. Its actions should be consistent with a One-Health approach, recognising the interconnections between communicable and chronic diseases, as well as between human and animal health and the environment. It should monitor the capacity of the national health systems to respond to communicable disease threats, in particular given the importance of this information in the preparation of the national preparedness and response plans, with a view to enabling Member States to better assess their health systems' capacities. The Centre should support the implementation of actions funded by the relevant Union funding programmes and instruments and related to communicable diseases, including their interconnection with chronic diseases, provide guidelines for treatment and case management based on a thorough assessment of the latest evidence, support epidemic and outbreak responses in Member States and third countries, including field response, and provide timely objective, reliable and easily accessible information on communicable diseases and their effect on the health-related quality of life of patients with chronic diseases to the public. The Centre should also establish clear procedures for cooperation with the public health actors in third countries, as well as international organisations competent in the field of public health hence contributing to EU’s commitment to reinforcing partners’ preparedness and response capacity. It should also work to ensure that there is sufficient, comparable and high quality data for the Union-wide surveillance and monitoring of major communicable diseases such as HIV, viral hepatitis B and C and Tuberculosis.
Amendment 92 #
Proposal for a regulation
Recital 7
Recital 7
(7) To effectively support the work of the Centre and ensure the fulfilment of its mission, Member States should be tasked to communicate to the Centre data on the surveillance and monitoring of communicable diseases, the interconnection with chronic conditions and other special health issues such as antimicrobial resistance and health care- associated infections related to communicable diseases, as well as broader health determinants including social determinants, available scientific and technical data and information relevant to the Centre’s mission, to notify the Centre of any serious cross-border threats to health, information on preparedness and response planning and health system capacity, and provide relevant information that may be useful for coordinating the response, as well as identify recognised competent bodies and public health experts available to assist in Union responses to health threats. All timelines, case definitions, indicators, standards, protocols and procedures for communication adopted by the Centre should be agreed with Member States and be mandatory for the Member States thereafter.
Amendment 101 #
Proposal for a regulation
Recital 8
Recital 8
(8) To enhance preparedness and response planning activities in the Union, the Centre’s operation of dedicated networks and networking activities should be broadened to reflect the scope of Regulation (EU) …/…. [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. To this end, the Centre should coordinate and provide technical and scientific expertise to the Commission and Member States through dedicated networks with competent coordinating bodies, including by encouraging cooperation within newly established networks for laboratories and for supporting transfusion, transplantation and medically assisted reproduction,.
Amendment 107 #
Proposal for a regulation
Recital 9
Recital 9
(9) With a view to enhance the effectiveness of epidemiological surveillance of communicable diseases and ofand monitoring of testing and treatment of communicable diseases, their interconnection to non-communicable diseases and the related special health issues in the Union, the Centre should be tasked with the further development of digital platforms and applications, supporting epidemiological surveillance at Union level, enabling the use of digital technologies, such as artificial intelligence and computer modelling and simulation, in the compilation and analysis of data, and providing Member States with technical and scientific advice to establish integrated epidemiologicalhealth surveillance systems. Such digital platforms and applications should be developed with integrated EU space generated data with the intention to be integrate them in the future European Health Data Space as governed by the Union legislation.
Amendment 114 #
Proposal for a regulation
Recital 10
Recital 10
(10) To strengthen the capacity of the Union and Member States to assess the epidemiological situation and perform accurate risk assessment and response, the Centre should in particular monitor, and report on trends in communicable diseases, support and their interconnections with chronic conditions, support, coordinate and facilitate evidence-based approach and response action of the Member States, provide recommendations for improvement of communicable disease prevention and control programmes established at the national and Union level, monitor and assess the capacity of national health systems for diagnosis, prevention and treatment of communicable diseases and their interconnection with and impact on chronic conditions, including in a gender- sensitive way, identify population groups at risk, including vulnerable populations, requiring specific measures, analyse the correlation of disease incidence with societal and environmental factors, consider the impact of co-morbidities on patients with communicable diseases and their treatment and identify risk factors for transmission and disease severity of communicable diseases, and identify research needs and priorities. The Centre should work with nominated national focal points for surveillance, forming a network that strategically advises the Centre on such matters and would promote the use of enabling sectors, such as EU space data and services.
Amendment 132 #
Proposal for a regulation
Recital 13
Recital 13
(13) With the aim of reducing the occurrence of epidemics and strengthening capacities to prevent communicable diseases in the Union, the Centre should, working in conjunction with Member States so as to take account of their experiences and respective situations, develop a framework for the prevention of communicable diseases, which addresses such issues as vaccine preventable diseases, awareness of transmission routes, antimicrobial resistance, health education, health literacy and behaviour change. and links with non- communicable diseases including vulnerable groups, health literacy, health promotion and disease prevention and behaviour change. Improving overall population health through disease prevention will help to reduce susceptibility to future infectious outbreaks.
Amendment 139 #
Proposal for a regulation
Recital 14
Recital 14
(14) The Centre should enhance preparedness and response capabilities at national and Union level by providing scientific and technical expertise to the Member States and the Commission. In this context the Centre, in close collaboration with the Member States and the Commission, should carry out various actions, including the development and coordination of Union and national preparedness and response plans and preparedness monitoring and evaluation frameworks, provide recommendations on capacities to prevent, prepare and respond to disease outbreaks and on the strengthening of national health systems. The Centre should broaden its collection and analysis of data in terms of epidemiological surveillance and related special health issues, progression of epidemic situations, unusual epidemic phenomena or new diseases of unknown origin, including in third countries, data on interconnections between communicable diseases and chronic conditions and especially on major as well as infection- based chronic diseases, molecular pathogen data and health systems data. To this end, the Centre should ensure appropriate datasets as well as the procedures to facilitate consultation and data transmission and access, carry out scientific and technical evaluation of prevention and control measures at Union level and work with agencies, competent bodies and organisations operating in the field of data collection.
Amendment 152 #
Proposal for a regulation
Recital 15
Recital 15
(15) Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]] provides for the early warning and response system enabling the notification at Union level of alerts related to serious cross-border threats to health which continues to be operated by the ECDC. Given that modern technologies can be of substantial support to combat health threats and to contain and reverse epidemics, the ECDC should work on updating this system to enable the use of artificial intelligence, High Performance Computing, in silico clinical trials and digital twin technologies and interoperable and privacy-preserving digital tools, such as mobile applications, with tracing functionalities identifying at- risk individuals.
Amendment 157 #
Proposal for a regulation
Recital 16
Recital 16
(16) The Centre should establish appropriate capacities to support international, interregional and field response, in accordance with Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. These capacities should enable the Centre to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’, to assist local responses to outbreaks of diseases. The Centre should therefore ensure permanent capacity to carry out missions to Member States as well as in third countries and to provide recommendations on response to health threats. These teams will also be able to be deployed under the Union Civil Protection Mechanism with the support of the Emergency Response Coordination Centre. The Centre should also support the strengthening of preparedness capacities under the International Health Regulations (IHR) in third countries, in order to address serious cross border threats to health and the consequences thereof.
Amendment 159 #
Proposal for a regulation
Recital 17
Recital 17
(17) To assist responses to outbreaks, which may spread within or to the Union, the Centre is to develop a permanent EU Health Task Force and a framework for theits mobilisation the EU Health Task Force in accordance with Decision No 1313/2013/EU of the European Parliament and of the Council 11 and facilitate the participation of Union field response experts in international response teams in support of and in close coordination with the Union Civil Protection Mechanism. The Centre should enhance the capability of its staff as well as experts from Union and EEA countries, candidate countries and potential candidates, as well as European Neighbourhood Policy countries and EU partner countries as referred to in Regulation (EU) No 233/2014 of the European Parliament and of the Council 12 , to effectively participate in field missions and crisis management. __________________ 11Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924). 12Regulation (EU) No 233/2014 of the European Parliament and of the Council of 11 March 2014 establishing a financing instrument for development cooperation for the period 2014-2020 (OJ L 77, 15.3.2014, p. 44).
Amendment 166 #
Proposal for a regulation
Recital 19
Recital 19
(19) This Regulation should not confer any regulatory powers on the Centre. However, the Centre should exercise broad coordination competences and the power to provide recommendations at Union, national and interregional level in the form of clear and uniform science- based proposals.
Amendment 185 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 1 – subparagraph 1
Article 3 – paragraph 1 – subparagraph 1
In order to enhance the capacity of the Union and the Member States to protect human health through the prevention and control of communicable diseases in humans, their interconnection with chronic conditions and those related special health issues set out in Article 2 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], the mission of the Centre shall be to identify, assess, and report on current and emerging threats to human health from communicable diseases, and provide recommendations for response at Union and national levels, as well as at regional level, if necessarys, and provide recommendations for response and coordinated action at Union and national levels, as well as at interregional and regional level, where appropriate. In providing such recommendations, the Centre shall take into account existing national crisis management plans and the respective circumstances of each Member State. The Centre shall also provide forecasts on the development of the identified health threats, that will help predict the demand of key medical technologies during the evolution of a possible health emergency, and specifically a forecast of Intensive Care Units usage and related device and diagnostic needs.
Amendment 196 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 1 – subparagraph 2
Article 3 – paragraph 1 – subparagraph 2
In the case of other outbreaks of illnesses of unknown origin that may spread within or to the Union, the Centre shall act on its own initiative until the source of the outbreak is known. In the case of an outbreak that clearly is not causrelated byto a communicable disease, the Centre shall act only in cooperation with the competent body upon request from that body.
Amendment 206 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
(b) provide analyses, scientific advice, opinions and support for actions by the Union and Member States on cross-border health threats, including risk assessments, analysis of epidemiological information, epidemiological modelling, anticipation and forecast, recommendations for actions to prevent and control communicable disease threats and other special health issues, contribution to defining research priorities, and scientific and technical assistance including training and other activities within its mandateincluding possible severe impact on patients suffering from chronic conditions, and contributions with regard to defining research priorities;
Amendment 219 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point e a (new)
Article 3 – paragraph 2 – point e a (new)
(ea) support national monitoring of the response to major communicable diseases to measure progress in tackling them across the Union;
Amendment 221 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point g
Article 3 – paragraph 2 – point g
(g) provide, upon request of the Commission or the HSCealth Security Committee (‘HSC’)established under Article 4 of Regulation (EU) …/… [the SCBTH Regulation], or on its own initiative, guidelines, recommendations and proposals for coordinated action for treatment and case management of communicable diseases and other special health issues relevant for public health, in cooperation with relevant societies; as well as unpredicted trends in the development of major chronic non- communicable diseases, including in cooperation with relevant organisations with experience and expertise in treatment and case management of those diseases and health issues, while avoiding any duplication of existing guidelines, except in cases where it is necessary to update such guidelines;
Amendment 226 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point h
Article 3 – paragraph 2 – point h
(h) support epidemic and outbreak response in Member States, and in third countries, in complementarity and close coordination with other Union emergency response instruments, in particular the Union Civil protection mechanism;
Amendment 229 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point j
Article 3 – paragraph 2 – point j
(j) provide, upon request of the Commission or the Health Security Committee (‘HSC’),SC, easily accessible and evidence-based communication messages to the public on communicable diseases, on the threats to health posed by them, on their possible interconnection with non-communicable diseases and impact on patients, suffering from severe or major non-communicable diseases and chronic conditions, and on the relevant prevention and control measures.
Amendment 250 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 851/2004
Article 4 – paragraph 1 – point b
Article 4 – paragraph 1 – point b
(b) notify the Centre of any serious cross-border threats to health, including spread of communicable diseases, unpredicted rise of known or unknown severe non-communicable diseases or chronic conditions and health-related environmental hazards, as soon as detected, through the Early Warning and Response System (EWRS), and promptly communicate response measures taken, as well as any relevant information that may be useful for coordinating the response as referred to in Article 21 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]]; and
Amendment 253 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 851/2004
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) identify, within the scope of the mission of the Centre, recognised competent bodies and public health experts who could be made available to assist in Union responses to health threats, such as by undertaking missions to Member States, cross-border regions or to third countries to provide expert advice and field investigations in the event of disease clusters or outbreaks.;
Amendment 264 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 1
Article 5 – paragraph 2 – subparagraph 1
The Centre shall ensure the integrated operation of the network for the epidemiological surveillance of the communicable diseases and of the related special health issues, such as unpredicted rise of known or unknown severe major non- communicable diseases or chronic conditions and health-related environmental hazards, including those referred to in points (i) and (ii) of point (a) of Article 2(1) of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]].
Amendment 272 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point a
Article 5 – paragraph 2 – subparagraph 2 – point a
(a) ensure the furthercontinuous development of the digital platforms and applications, including the platform for surveillance established under Article 14 of Regulation (EU) .../... [the SCBTH Regulation], supporting epidemiological and health surveillance at Union level, supporting Member States with technical and scientific advice to establish integrated surveillance systems enabling real-time surveillance where appropriate, benefiting from existing EU space infrastructures and services;
Amendment 279 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point b
Article 5 – paragraph 2 – subparagraph 2 – point b
(b) provide quality assurance by monitoring and evaluating epidemiological and health surveillance activities (including setting surveillance standards and monitoring data completeness) of the dedicated surveillance networks to ensure optimal operation;
Amendment 283 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point c
Article 5 – paragraph 2 – subparagraph 2 – point c
(c) maintain database(s) for such epidemiological and health surveillance, coordinate with the hosts of other relevant databases, and work towards harmonised approaches to data collection and modelling;
Amendment 291 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point g
Article 5 – paragraph 2 – subparagraph 2 – point g
(g) ensure the interoperability of the digital platforms for surveillance with digital infrastructures allowing for the health data to be used for healthcare, research, policy making and regulatory purposes and with a view to integrate those platforms and infrastructures in the European Health Data Space, as regulated by Union legislation, and make use of other relevant data, for example environmental factors, or phenomena with potential severe health impact at Union or inter-regional level.
Amendment 296 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 4 – point a
Article 5 – paragraph 4 – point a
(a) monitor and report on trends in communicable diseases and their interconnection to chronic conditions and implications for patients with severe non- communicable diseases and chronic conditions over time and across Member States and in third countries, based on agreed indicators, to assess the present situation and facilitate appropriate evidence-based action, including through the identification of specifications for harmonised data collection from member states
Amendment 300 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 4 – point d
Article 5 – paragraph 4 – point d
(d) monitor and assess health systems’ capacityhealth systems and support Member States in their assessment of the capacity of their health systems for diagnosis, prevention and treatment of specific communicable diseases, such as HIV, viral Hepatitis and Tuberculosis, as well as patients’ safety;
Amendment 309 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 4 – point f
Article 5 – paragraph 4 – point f
(f) contribute to the assessment of the burden of communicable diseases on the population using data, such as disease prevalence, complications, clinical links with non-communicable diseases, development of chronic co-morbidities, cancers, hospitalisation and mortality, and ensure that this data is disaggregated on age, gender and disability;
Amendment 338 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 2
Article 5a – paragraph 2
2. TIn close collaboration with Member States, the European Medicines Agency and other relevant Union bodies and agencies, as well as with international organisations and civil society, the Centre shall develop a framework for the prevention of communicable diseases and special issues, including socio-economic risk factors, vaccine preventable diseases, antimicrobial resistance, health education, health literacy and behaviour change. That framework shall constantly consult with representatives of civil society and industry, in particular scientific societies, in relation to its activities aimed at the prevention of communicable diseases, fighting against misinformation, disinformation and propaganda regarding vaccination, preventive measures and medical treatment, as well as information campaigns regarding the links between disease areas and regarding the risks for patients with non-communicable diseases or suffering from chronic conditions.
Amendment 349 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 3
Article 5a – paragraph 3
3. The Centre shall evaluate and monitor communicable disease prevention and control programmes in order to provide the evidence for recommendations to coordinate, strengthen and improve these programmes at the national, inter- regional and Union level, and where appropriate at the international levels.
Amendment 358 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EC) No 851/2004
Article 5b – paragraph 1 – subparagraph 1
Article 5b – paragraph 1 – subparagraph 1
The Centre shall provide scientific and technical expertise to the Member States and the Commission in collaboration with relevant Union bodies and agencies and international organisations and civil society in accordance with appropriate working arrangements established with the Commission in the field of preparedness and response planning.
Amendment 370 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
(i) assesssupport Member States in their assessment of the capacity of their health systems’ capacity to detect, prevent, respond to and recover from outbreaks of communicable diseases and related health risks, identify gaps and provide recommendations for the strengthening of health systems, to be implemented with Union support as appropriate;
Amendment 409 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 851/2004
Article 8 – paragraph 3
Article 8 – paragraph 3
3. The Centre shall work with the Commission and the HSC on the EWRS updates, including for the use of modern technologies, such as digital mobile applications, artificial intelligence and computer modelling and simulation models, or other technologies for automated contact tracing, building upon the contact tracing technologies developed by the Member States and on defining the functional requirements of the EWRS.
Amendment 417 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 851/2004
Article 8a – paragraph 2
Article 8a – paragraph 2
2. The risk assessment shall includes referred to in paragraph 1 shall include, where possible, general and targeted recommendations for response as a basis for coordination in the HSC. , including, but not limited, to: (a) a forecast on the evolution of a health crisis and the risk of health emergency; (b) a forecast on the demand of medicines, vaccines, medical equipment, protective equipment and hospital capacity; (c) identification of vulnerable groups in the society, such as patients, suffering chronic conditions, patients with severe non-communicable diseases, elderly, children, pregnant women and professions with a high risk of infection or transmission, including specific needs for medicines and hospital capacity for those most vulnerable groups; (d) identification of possible protective measures and assessment of their efficacy; (e) assessment of the possible need for activation of the Health Task Force and the Union Civil Protection Mechanism.
Amendment 424 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 851/2004
Article 8b – paragraph 1 – point a
Article 8b – paragraph 1 – point a
(a) national or inter-regional responses to the serious cross-border threat to health;
Amendment 427 #
Proposal for a regulation
Article 1 – paragraph 1 – point 11
Article 1 – paragraph 1 – point 11
Regulation (EC) No 851/2004
Article 8b – paragraph 1 – point b a (new)
Article 8b – paragraph 1 – point b a (new)
(ba) recommendation for the deployment of the Health Task Force or activation of the Union Civil Protection Mechanism.
Amendment 434 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point b
Article 1 – paragraph 1 – point 13 – point b
Regulation (EC) No 851/2004
Article 11 – paragraph 1a – point a
Article 11 – paragraph 1a – point a
(a) epidemiological surveillance of communicable diseases, other health threats such as unpredicted rise of known or unknown severe non-communicable diseases or chronic conditions and related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1) of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]];
Amendment 435 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point b
Article 1 – paragraph 1 – point 13 – point b
Regulation (EC) No 851/2004
Article 11 – paragraph 1a – point b
Article 11 – paragraph 1a – point b
(b) the progression of epidemic situations, including for modelling, anticipation and scenario development, the assessment of vulnerable groups and the forecast on specific demand for medicines, equipment and hospital capacity;
Amendment 437 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point b
Article 1 – paragraph 1 – point 13 – point b
Regulation (EC) No 851/2004
Article 11 – paragraph 1a – point c
Article 11 – paragraph 1a – point c
(c) unusual epidemic phenomena or new communicable and non- communicable diseases of unknown origin, including those in third countries;
Amendment 441 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point c
Article 1 – paragraph 1 – point 13 – point c
Regulation (EC) No 851/2004
Article 11 – paragraph 2 – point c
Article 11 – paragraph 2 – point c
(c) work in close cooperation with the competent bodies of the organisations and relevant counterparts operating in the field of data collection from the Union, third countries, the WHO, and other international organisations; and, the scientific community and civil society, while ensuring robust safeguards concerning transparency and accountability;
Amendment 454 #
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
1. The Centre shall establish a permanent capacity, as well as an enhanced emergency capacity to mobilise and deploy the EU Health Task Force including the Centre’'s staff and experts from Member States and fellowship programmes, to assist local response to outbreaks of communicable diseases in Member States and in third countries.
Amendment 457 #
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EC) No 851/2004
Article 11a – paragraph 2
Article 11a – paragraph 2
2. The Centre shall develop a framework and establish procedures with the Commission to mobilisedeploy the permanent capacity and mobilise the emergency capacity of the EU Health Task Force.
Amendment 460 #
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EC) No 851/2004
Article 11a – paragraph 4 – subparagraph 1
Article 11a – paragraph 4 – subparagraph 1
The Centre shall develop with the Commission a framework for the deployment of the permanent capacity and the mobilisation of the EU Health Task Force, in view of action under Decision No 1313/2013/EU*.
Amendment 463 #
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EC) No 851/2004
Article 11a – paragraph 6
Article 11a – paragraph 6
6. The Centre shall maintain a permanent capacity to carry out missions to Member States, upon request of the Commission and Member States, to provide recommendations on response to threats to health within its mandate.
Amendment 481 #
Proposal for a regulation
Article 1 – paragraph 1 – point 19 – point c
Article 1 – paragraph 1 – point 19 – point c
Regulation (EC) No 851/2004
Article 18 – paragraph 8
Article 18 – paragraph 8
8. The director may invite experts or representatives of professional or scientific bodies, or non-governmental organisations, including but not limited to health care professionals, academics and manufacturers, with recognised experience in disciplines related to the work of the Centre to cooperate in specific tasks and to take part in the relevant activities of the Advisory Forum. In addition, the Commission may suggest to the director experts or representatives of professional or scientific bodies, or non- governmental organizations to be invited on an ad-hoc basis.; Those experts shall be excluded from any discussions and deliberations within the Advisory Forum and shall solely be invited to provide specific requested information on a predefined topic.