Activities of Joanna KOPCIŃSKA related to 2020/0320(COD)
Reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control
Amendments (19)
Amendment 88 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) In order to have high-performing health systems accessible for all, there is a need for a holistic approach to public health. The Centre should be tasked with the monitoring of non-communicable diseases and of the impact that infectious diseases have on health systems at large. Based on the Centre's vast experience with Union-level surveillance and monitoring of communicable diseases, its existing tool for data collection (TESSy) and its links to national public health bodies responsible for both communicable and non-communicable diseases, the Centre is in a unique position to deliver effectively a one-stop-shop for health information that can be used for policy decision-making.
Amendment 149 #
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, noting in particular references to the risks posed by Artificial Intelligence (AI), for example biased datasets, flawed system design, lack of quality data, overdependence on automated decision-making etc., and the importance of establishing safeguards to mitigate these risks during the design and implementation phases of AI technologies.
Amendment 169 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
Amendment 173 #
Proposal for a regulation
Recital 20 b (new)
Recital 20 b (new)
Amendment 178 #
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 4 a (new)
Article 2 – paragraph 1 – point 4 a (new)
(4a) ‘major non-communicable disease’ means a chronic disease which tends to be of long duration and is the result of a combination of genetic, physiological, environmental and behavioural factors, such as a cardiovascular disease, cancer, respiratory disease, diabetes or mental illness, and which affects a significant number of people in the Union;
Amendment 187 #
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 related diseases and health issues, including 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 related diseases and health issues, and provide recommendations for response at Union and national levels, as well as at regional level, if necessary.
Amendment 228 #
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 a (new)
Article 3 – paragraph 2 – point h a (new)
(ha) collect information, within its existing infrastructure, on major non- communicable diseases, in particular those whose developments and treatments are impacted significantly by pandemics, such as cancer, diabetes or mental illness;
Amendment 260 #
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 – subparagraph 1 a (new)
Article 4 – paragraph 1 – subparagraph 1 a (new)
Member States shall also, together with the Centre, establish timelines, case definitions, indicators, standards, protocols and procedures for exchange of the information on major non- communicable diseases referred to in point (ha) of Article 3(2).
Amendment 267 #
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 ofrelated diseases and health issues, including those 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 274 #
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, based on a data protection impact assessment (DPIA) to be conducted prior to their deployment, which shall be used to 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 280 #
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 fulfilling this role, the Centre shall minimise the risks that may emerge from the transfer of inaccurate, incomplete or ambiguous data from one database to another, as well as establish robust procedures for data quality review.
Amendment 284 #
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 a (new)
Article 5 – paragraph 2 – subparagraph 2 – point c a (new)
(ca) collect and analyse information provided by Member States on the impact of pandemics on the causes and treatment of relevant major non-communicable diseases;
Amendment 299 #
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 c
Article 5 – paragraph 4 – point c
(c) contribute to the evaluation and monitoring of communicable disease prevention and control programmes, as well as prevention and control programmes in relation to major non- communicable diseases, in order to provide the evidence for recommendations to strengthen and improve these programmes at the national and Union levels;
Amendment 308 #
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 and mortality, and ensure that this data is disaggregated on age, gender and disability, as well as contribute to the assessment of the causes and treatment of major non-communicable diseases;
Amendment 366 #
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) develop targeted activities addressing at-risk groups and community preparedness, in particular taking into account the risks associated with the causes and treatment of major non- communicable diseases;
Amendment 412 #
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 433 #
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
Article 11 – paragraph 1a
1a. TUnder the supervision of the Commission, the Centre shall collect data and information, and will ensure links to relevant research data and outputs on:
Amendment 444 #
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, including anonymous data and pseudonymous data, in line with the principle of data minimisation as defined in point (c) of Article 5(1) of Regulation (EU) 2016/679, where such data are 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 487 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Regulation (EC) No 851/2004
Article 21 – paragraph 6
Article 21 – paragraph 6
6. The Centre shall develop, deploy and operate an information system capable of exchanging classified and sensitive non- classified information as specified in this Article, in accordance with Articles 27 and 33 of Regulation (EU) 2018/1725.