63 Amendments of Sara CERDAS related to 2020/0320(COD)
Amendment 69 #
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 which has particularly affected people with chronic non- communicable diseases. From the challenges experienced in responding to the pandemic it became clear that the Centre’s role in the Union’s framework for health crisis preparedness and response should be strengthened.
Amendment 72 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) Improving overall population health through disease prevention will help to reduce susceptibility to future infectious outbreaks. Given the links between non-communicable and communicable diseases, an important part of communicable disease control requires consideration of non-communicable diseases. Furthermore, as many outbreaks are of zoonotic origin, a One Health approach is needed considering the interactions between humans, animals and the environment in order to face the emerging threats of zoonotic diseases.
Amendment 77 #
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 highlighted shortcomings in how the data is communicated and gathered by the Centre during the COVID-19 crisis. Notably, there were discrepancies in the reporting of reliable data and the lack of such data directly affected the Centre’s modelling and forecasting capacity. These issues and others have impeded the important work by the Centre and this Regulation should strengthen the mandate further to ensure inter alia improved coordination, epidemiological surveillance and communication.
Amendment 82 #
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. Its actions should be consistent with a One-Health approach, recognising the interconnections 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. The monitoring of the health systems’ capacity should be based on standardised indicators and definitions in order to ensure comparability. When assessing Member States’ health systems capacity, the Centre should inter alia take into account reported health indicators by Eurostat. To the greatest extent possible, the Centre should further explore possible synergies with the work on health systems performance assessment, in particular by the Commission, the OECD and the WHO. The Centre should support the implementation of actions funded by the relevant Union funding programmes and instruments and related to communicable 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 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.
Amendment 87 #
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. Its actions should be consistent with a One-Health approach, recognising the interconnections between human and animal health and the environment. It should monitor the capacity of the national health systems to respond to communicable disease threats and other cross-border threats to health, in particular given the importance of this information in the preparation of the national preparedness and response plans. The Centre should support the implementation of actions funded by the relevant Union funding programmes and instruments and related to communicable diseases, provide guidelines for surveillance, monitoring, screening, diagnosis, 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 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.
Amendment 90 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) Taking into account the clear links between communicable and non- communicable diseases and a need for a truly integrated approach to health, the Centre should be tasked with the identification and monitoring of the relationship between non-communicable and communicable diseases considering the substantial effect of comorbidities on health outcomes as observed during the COVID-19 pandemic.
Amendment 102 #
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 and the Health Security Committee through dedicated networks with competent coordinating bodies, including newly established networks for laboratories and for supporting transfusion, transplantation and medically assisted reproduction,.
Amendment 120 #
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 timely and accurate risk assessment and response, the Centre should in particular monitor and report on trends in communicable diseases, support and facilitate evidence-based response action, 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, including in a gender-sensitive way, identify population groups at risk requiring specific measures, analyse the correlation of disease incidence with societal and environmental factors, 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 134 #
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 develop a framework for the prevention of communicable diseases, which addresses such issues as vaccine preventable diseases, vaccine hesitancy, antimicrobial resistance, healthcare-associated infections related to communicable diseases, health education, health literacy, health inequalities and behaviour change.
Amendment 136 #
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 develop a framework for the prevention of communicable diseases, which addresses such issues as vaccine preventable diseases, antimicrobial resistance, health education, health literacy and behaviour change. This framework should be aligned with the best evidence available and WHO guidelines, when available.
Amendment 138 #
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 of Union andpreparedness and response plans and the contribution to the development of the 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, 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 144 #
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 of Union andpreparedness and response plans and support the development of 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, 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 147 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) The Centre should broaden its collection and analysis of data in terms of epidemiological surveillance and related special health issues, non-communicable diseases, vaccine effectiveness and long- term immunity, progression of epidemic situations, unusual epidemic phenomena or new diseases of unknown origin, including in third countries, 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 161 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
Amendment 162 #
Proposal for a regulation
Recital 17 b (new)
Recital 17 b (new)
(17b) The Centre should work in close cooperation with the competent bodies and the international organisations in the field of public health in particular the World Health Organization (WHO).
Amendment 163 #
Proposal for a regulation
Recital 17 c (new)
Recital 17 c (new)
(17c) The Centre should communicate in an effective and transparent manner about current and emerging health risks to the general public. The Centre should timely publish the scientific studies, overviews, surveys, reports, rapid risk assessments and the assessments of the health systems’ capacities in order to increase transparency. The Centre should in this regard address issues regarding transparency as stated in the European Ombudsman’s decision in strategic inquiry OI/3/2020/TE.
Amendment 164 #
Proposal for a regulation
Recital 17 d (new)
Recital 17 d (new)
(17d) The Centre should ensure gender and geographical balance at staff and management levels as well as ensure a gender sensitive approach in all its operations.
Amendment 172 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
Amendment 180 #
Proposal for a regulation
Article 1 – paragraph 1 – point 1
Article 1 – paragraph 1 – point 1
Regulation (EC) No 851/2004
Article 2 – paragraph 1 – point 6 a (new)
Article 2 – paragraph 1 – point 6 a (new)
(6a) ‘non-communicable disease’ means a non-communicable disease as defined by the World Health Organisation;
Amendment 189 #
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 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 other cross- border threats to health, and provide recommendations for response at Union and national levels, as well as at regional level, if necessary.
Amendment 190 #
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 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 non- communicable diseases, and provide recommendations for response at Union and national levels, as well as at regional level, if necessary.
Amendment 208 #
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, guidelines 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 mandate;
Amendment 209 #
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 a (new)
Article 3 – paragraph 2 – point b a (new)
(ba) identify, monitor and collect data on non-communicable diseases which can cause an increase in the incidence, severity and mortality of communicable diseases;
Amendment 224 #
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 HSC, or its own initiative, guidelines for surveillance, monitoring, screening, diagnosis, treatment and case management of communicable diseases and other special health issues relevant for public health, in cooperation with relevant societies;
Amendment 232 #
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’), or on its own initiative, evidence-based communication messages to the public on communicable diseases, on the threats to health posed by them and on the relevant prevention and control measures.
Amendment 242 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 3 a (new)
Article 3 – paragraph 3 a (new)
3a. This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Regulation (EU) 2016/679 and Directive 2002/58/EC, or the obligations of the Centre and the Commission relating to their processing of personal data under Regulation (EU) 2018/1725, when fulfilling their responsibilities.
Amendment 255 #
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 a (new)
Article 4 – paragraph 1 – point c a (new)
(ca) develop national preparedness and response plans in accordance with Article 6 of Regulation (EU) .../... [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], update them in a timely manner taking into account the Centre’s recommendations, and report on their preparedness and response planning and implementation at national level in accordance with Article 7 of Regulation (EU) .../... [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]];
Amendment 257 #
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 a (new)
Article 4 – paragraph 1 – point c a (new)
(ca) promote the automatisation of the data communication process between the national and the Union surveillance systems;
Amendment 258 #
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 b (new)
Article 4 – paragraph 1 – point c b (new)
(cb) facilitate the digitalisation and the automation of data collection and the data communication process between the national and the Union surveillance systems;
Amendment 259 #
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 c (new)
Article 4 – paragraph 1 – point c c (new)
(cc) immediately notify any delay in the reporting of the data to the Centre with an explanation and plan as to when the data will be submitted;
Amendment 265 #
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 non- communicable diseases in accordance with Article 3(2) of this Regulation, and of the 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 273 #
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 further development of the digital platforms and applications supporting epidemiological 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, with the aim to simplify the data exchange process and reduce the administrative burden at Union and Member State levels;
Amendment 304 #
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’ capacity, based on standardised indicators and definitions, for diagnosis, prevention and treatment of specific communicable diseases as well as patients’ safety;
Amendment 312 #
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, hospitalisation, morbidity and mortality, and ensure that this data is disaggregated on age, gender and disability;
Amendment 317 #
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 h a (new)
Article 5 – paragraph 4 – point h a (new)
(ha) identify, monitor and collect data on non-communicable diseases which can cause increase in the incidence, severity and mortality of communicable diseases;
Amendment 322 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 5 –- subparagraph 3 a (new)
Article 5 – paragraph 5 –- subparagraph 3 a (new)
National focal points shall, to the greatest extent possible, be the same as the National IHR Focal Points, to minimise the duplication of resources and efforts.
Amendment 334 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 1
Article 5a – paragraph 1
1. The Centre shall support Member States to strengthen their communicable disease prevention and control systems, improving and facilitating the data collection process with real-time and interoperability sharing of data, as well as capacitating TESSy and other platforms to better address the monitoring and surveillance needs.
Amendment 339 #
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. The Centre shall develop a framework for the prevention of communicable diseases and special issues, including vaccine preventable diseases, vaccine hesitancy, antimicrobial resistance, healthcare-associated infections related to communicable diseases, health education, health literacy, health inequalities and behaviour change.
Amendment 352 #
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 a (new)
Article 5a – paragraph 3 a (new)
3a. The Centre shall develop a platform to monitor the vaccination coverage by Member States, taking into account Member States and regional specificities of the vaccination schemes.
Amendment 354 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5a – paragraph 4
Article 5a – paragraph 4
4. The Centre shall coordinate independent post-marketing vaccines effectiveness and safety monitoring studies collecting new information and/or using the relevant data collected by competent bodies. Besides vaccine-induced immunity, the Centre shall collect data on natural immunity and long-term immunity. That work shall be conducted jointly with the European Medicines Agency and notably though a new vaccine monitoring platform.;
Amendment 367 #
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 2 – point h
Article 5b – paragraph 1 – subparagraph 2 – point h
(h) support the Member States to develop targeted activities addressing at- risk groups and community preparedness;
Amendment 371 #
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 2 – point i
Article 5b – paragraph 1 – subparagraph 2 – point i
(i) assess health systems’ capacity based on standardised indicators and definitions to detect, prevent, respond to and recover from outbreaks of communicable diseases, identify gaps and provide recommendations for the strengthening of health systems, to be implemented with Union support as appropriate;
Amendment 377 #
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 2 – point i a (new)
Article 5b – paragraph 1 – subparagraph 2 – point i a (new)
(ia) publish the assessments of the health systems’ capacity together with the provided recommendations ensuring full transparency;
Amendment 378 #
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 2 – point j
Article 5b – paragraph 1 – subparagraph 2 – point j
(j) bolster modelling, anticipation and forecast capacity of the Centre; and of the Member States; and
Amendment 380 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 – point a
Article 1 – paragraph 1 – point 7 – point a
Regulation (EC) No 851/2004
Article 6 – paragraph 1a
Article 6 – paragraph 1a
1a. The Centre shall provide concrete analyses and recommendations for actions to prevent and control communicable disease threatss and other cross-border threats to health upon request of the Commission.;
Amendment 386 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 – point b
Article 1 – paragraph 1 – point 7 – point b
Regulation (EC) No 851/2004
Article 6 – paragraph 3 – subparagraph 2
Article 6 – paragraph 3 – subparagraph 2
To carry out the studies referred to in the first paragraph, the Centre shall have access to health data made available or exchanged through digital infrastructures and applications, in accordance with data protection ruleRegulations (EU) 2016/6794 and (EU) 2018/1725 and with Directive 2002/58/EC on privacy and electronic communications, allowing for the health data to be used for healthcare, research, policy making and regulatory purposes. For the purposes of studies under the first paragraph, the Centre shall also make use of other relevant data, for example on environmental and socio-economic factors.;
Amendment 388 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 – point b
Article 1 – paragraph 1 – point 7 – point b
Regulation (EC) No 851/2004
Article 6 – paragraph 3 – subparagraph 2
Article 6 – paragraph 3 – subparagraph 2
To carry out the studies referred to in the first paragraph, the Centre shall have access to health data made available or exchanged through digital infrastructures and applications, in accordance with data protection rules at Union and Member States level, allowing for the health data to be used for healthcare, research, policy making and regulatory purposes. For the purposes of studies under the first paragraph, the Centre shall also make use of other relevant data, for example on environmental and socio-economic factors.;
Amendment 389 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 – point b
Article 1 – paragraph 1 – point 7 – point b
Regulation (EC) No 851/2004
Article 6 – paragraph 3 – subparagraph 2 a (new)
Article 6 – paragraph 3 – subparagraph 2 a (new)
The Centre shall make available the studies referred to in the first subparagraph in a timely manner.
Amendment 394 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EC) No 851/2004
Article 7 – paragraph 1– point c a (new)
Article 7 – paragraph 1– point c a (new)
(ca) at the request of the Health Security Committee
Amendment 405 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 851/2004
Article 8 – paragraph 2 – point c
Article 8 – paragraph 2 – point c
(c) ensure that the EWRS is efficiently and effectively linked with other Union alert systemnd international alert systems and databases.
Amendment 410 #
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 continuous updates, including for the use of modern technologies, such as digital mobile applications, artificial intelligence 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 422 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 851/2004
Article 8a – paragraph 4 a (new)
Article 8a – paragraph 4 a (new)
4a. The Centre shall work together with the Member States to improve the risk assessment capacity of the Member States and shall provide training in this area if necessary.
Amendment 425 #
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 a (new)
Article 8b – paragraph 1 – point a a (new)
(aa) Union responses to the serious cross-border threat to health
Amendment 429 #
Proposal for a regulation
Article 1 – paragraph 1 – point 12 – point c
Article 1 – paragraph 1 – point 12 – point c
Regulation (EC) No 851/2004
Article 9 – paragraph 6
Article 9 – paragraph 6
6. The Centre shall, as appropriate, support and coordinate training programmes, in particular in epidemiological surveillance, field investigations, preparedness and prevention, and public health research. and risk communication. Those programmes shall take into consideration the need for updating training and shall respect the principle of proportionality and the training needs of Member States;
Amendment 430 #
Proposal for a regulation
Article 1 – paragraph 1 – point 12 – point c
Article 1 – paragraph 1 – point 12 – point c
Regulation (EC) No 851/2004
Article 9 – paragraph 6
Article 9 – paragraph 6
6. The Centre shall, as appropriate, support and coordinate training programmes, in particular in epidemiological surveillance, field investigations, preparedness and prevention, response to public health emergencies, and public health research.;
Amendment 439 #
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 e a (new)
Article 11 – paragraph 1a – point e a (new)
(ea) implementation of the Centre’s recommendations on countermeasures by Member States and the outcomes thereof.
Amendment 445 #
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 d
Article 11 – paragraph 2 – point d
(d) develop solutions to access relevant health data made available or exchanged through digital infrastructures, in accordance with data protection ruleRegulations (EU) 2016/679 and (EU) 2018/1725 and with Directive 2002/58/EC on privacy and electronic communications, allowing for the health data to be used for healthcare, research, policy making and regulatory purposes; and provide and facilitate controlled access to health data to support public health research.;
Amendment 449 #
Proposal for a regulation
Article 1 – paragraph 1 – point 13 – point d
Article 1 – paragraph 1 – point 13 – point d
Regulation (EC) No 851/2004
Article 11 – paragraph 4
Article 11 – paragraph 4
4. In the situations of urgency related to severity or novelty of a serious cross- border threat to health or to the rapidity of its spread among the Member States, the Centre shall make available epidemiological forecasts as referred to in point (g) of Article 5(4), upon request of the Commission, Member States or the European Medicines Agency, in an objective, reliable and easily accessible way and on the basis of the best available information.
Amendment 465 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15 – point a
Article 1 – paragraph 1 – point 15 – point a
Regulation (EC) No 851/2004
Article 12 – paragraph 1 – subparagraph 1
Article 12 – paragraph 1 – subparagraph 1
The Centre shall communicate on its own initiative within the scope of its mission, after having given prior information to the Member States and, to the Commission and to the Health Security Committee.
Amendment 468 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15 – point a
Article 1 – paragraph 1 – point 15 – point a
Regulation (EC) No 851/2004
Article 12 – paragraph 1 – subparagraph 2
Article 12 – paragraph 1 – subparagraph 2
The Centre shall ensure that the public or any interested party is rapidly given objective, reliable, evidence-based and easily accessible information with regard to the results of its work. The Centre shall make available information for the general public, including through a dedicated website It shall also publish its opinions produced in accordance with Article 6.; the information communications shall be aligned with the HSC communications.
Amendment 470 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15 – point b
Article 1 – paragraph 1 – point 15 – point b
Regulation (EC) No 851/2004
Article 12 – paragraph 2
Article 12 – paragraph 2
Amendment 472 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15 – point b
Article 1 – paragraph 1 – point 15 – point b
Regulation (EC) No 851/2004
Article 12 – paragraph 2
Article 12 – paragraph 2
Amendment 486 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Regulation (EC) No 851/2004
Article 21 – paragraph 5 a (new)
Article 21 – paragraph 5 a (new)
5a. The Centre shall ensure the confidentiality of health data under the data protection legislation of Member States and the Union.