46 Amendments of Petar VITANOV 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 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 108 #
Proposal for a regulation
Recital 9
Recital 9
(9) With a view to enhance the effectiveness of epidemiological surveillance of communicable diseases and of 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, in the compilation and analysis of data, and providing Member States with technical and scientific advice to establish integrated epidemiological 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 and in full respect of Articles 7 and 8 of the Charter of Fundamental Rights of the European Union.
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 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 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 148 #
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 technologies and interoperable and privacy-preserving digital tools, such as mobile applications, with tracing functionalities identifying at- risk individuals.
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 170 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) Where processing of personal data is not necessary to perform the activities of the Centre, use of anonymous data and otherwise pseudonymous data should be ensured, in line with the principle of data minimisation. The anonymisation should consist of rendering personal data anonymous in such a manner that the data subject is not or no longer identifiable, through techniques such as the randomisation (altering the veracity of the data in order to remove the strong link between the data and the individual) or generalisation (consisting of generalising or diluting, the attributes of data subjects by modifying the respective scale or order of magnitude).
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 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 239 #
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 a (new)
Article 3 – paragraph 2 a (new)
2a. In performing its tasks under Article 3(2) of this Regulation, the Centre shall guarantee that its processing operations rigorously respect the data protection principles of lawfulness, fairness and transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality, as well as the principles of data protection by design and by default as defined in Article 27 of Regulation (EU) 2018/1725, while also determining appropriate technical and organisational security measures in accordance with Article 33 of that Regulation. A Code of Conduct for processing of personal data in accordance with Article 40 of Regulation (EU) 2016/679 shall also be developed.
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 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 268 #
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) ensurfacilitate 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 integrate, while benefiting from existing EU space infrastructures and suerveillance systems enabling real-time surveillance where appropriate, benefiting from existing EU space infrastructures and servicesices; these digital platforms and applications shall be implemented with privacy-enhancing technologies taking into account the state of the art;
Amendment 281 #
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 surveillance, coordinate with the hosts of other relevant databases, and work towards harmonised approaches to data collection and modelling; in this regard, the Centre shall adopt procedures for data quality review, as well as specific measures for minimising risks that may emerge from the transfer of inaccurate or incomplete data from one database to another;
Amendment 292 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
(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, in particular by Article 6(1) of Regulation (EU) 2016/679, and make use of other relevant data, for example environmental factors.
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 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 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 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 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 384 #
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
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 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 407 #
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 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. All contact tracing applications shall use privacy-enhancing technologies and be designed in line with the principles of data minimisation, purpose limitation and storage limitation. Any deployment of technological or organisational solutions that involve novel forms of data collection and usage shall be carried out only after a data protection impact assessment (DPIA).
Amendment 411 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 851/2004
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Centre as processor shall have the responsibility to ensure the security and confidentiality of the processing operations of personal data carried out within the EWRS and in the context of interoperability of contact tracing applications, in accordance with the obligations laid down in Articles 33, 34(2) and 36 of Regulation (EU) 2018/1725 of the European Parliament and of the Council*
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 443 #
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 operating in the field of data collection from the Union, third countries, the WHO, and other international organisations, in full compliance with Regulation (EU) 2018/1725, including Chapter V thereof; and
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 446 #
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 rules, 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 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