Activities of Joëlle MÉLIN related to 2020/0320(COD)
Shadow 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 (55)
Amendment 65 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) The WHO alerted all the Member States on 31 December 2019, but the ECDC did not publicly relay the information until 22 January 2020.
Amendment 85 #
Proposal for a regulation
Recital 6
Recital 6
(6) In this respect, the Centre should be tasked with providing as quickly as possible 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, particularly in view of the most recent human or animal epidemics. 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 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 104 #
Proposal for a regulation
Recital 8
Recital 8
(8) To enhance preparedness and response planning and forecasting 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 newly established networks for laboratories and for supporting transfusion, transplantation and medically assisted reproduction,
Amendment 123 #
Proposal for a regulation
Recital 11
Recital 11
(11) The Centre should help strengthen the capacity within the Union to anticipate, diagnose, detect, identify and characterise infectious agents which may threaten public health by ensuring the operation of the network of Union reference laboratories in accordance with Regulation (EU) …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. This network is responsible for the promotion of good practice and alignment on diagnostics, testing methods, and use of tests, in order to ensure uniform surveillance, notification and reporting of diseases, as well as strengthened quality of testing and surveillance.
Amendment 126 #
Proposal for a regulation
Recital 12
Recital 12
(12) Where in case of cross-border health threats posed by communicable diseases, the blood and transplant services in the Member States can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. These services are dependent on rapid risk assessments by the Centre to safeguard patients in need of a therapy from a substance of human origin from the transmission of such a communicable disease. Such risk assessments serve as the basis for appropriate adaptation of measures setting standards for quality and safety of the substances of human origin. The Centre should therefore establish and operate a network ofadvise the national blood and transplant services and their authorities to serve this purposethis end.
Amendment 131 #
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 frameworkcooperate with the Member States for the prevention of communicable diseases, which addresses such issues as vaccine preventable diseases, antimicrobial resistance, health education, health literacy and behaviour change.
Amendment 140 #
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 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, molecular pathogen data and health systems data. To this end, the Centre should ensure appropriate datasets, complying with the rules laid down by the General Data Protection Regulation and the national rules in force, 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 151 #
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, complying with the rules laid down by the GDPR and the national rules in force.
Amendment 156 #
Proposal for a regulation
Recital 16
Recital 16
(16) The Centre should establish appropriate capacities to support international 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 capacity to carry out missions to Member States, at their request, 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 192 #
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 and animal 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 provide recommendations for response at Union and national levels, as well as at regional level, if necessary.
Amendment 197 #
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 caused by a communicable disease, the Centre shall act only in cooperation with the competent national body upon request from that body.
Amendment 200 #
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 3
Article 3 – paragraph 1 – subparagraph 3
In pursuing its mission, the Centre shall take full account of the requests and responsibilities of the Member States, the Commission and other Union bodies or agencies, and of the requests and responsibilities of international organisations active within the field of public health, in order to ensure comprehensiveness, coherence and complementarity of action.
Amendment 202 #
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 a
Article 3 – paragraph 2 – point a
(a) search for, collect, collate, evaluate and disseminate relevant scientific and technical data and information, considering the latest technologies, and if necessary in anticipation of the spread of an epidemic;
Amendment 213 #
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 c
Article 3 – paragraph 2 – point c
(c) coordinate thefacilitate cooperation between the national European networking of bodies operating in the fields within the Centre’s mission, including networks arising from public health activities supported by the Commission and operating the dedicated networks;
Amendment 216 #
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
Article 3 – paragraph 2 – point e
(e) monitorfacilitate the monitoring of national health systems’ capacity relevant to the management of communicable disease threats and other special health issues;
Amendment 227 #
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
Amendment 245 #
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 a
Article 4 – paragraph 1 – point a
(a) communicate to the Centre in a timely manner and according to agreed case definitions, indicators, standards, protocols and procedures data on the surveillance of communicable diseases and other special health issues undertaken in accordance with Article 13 of Regulation (EU) …/… [OJ: please insert the number of Regulation SCBTH [ISC/2020/12524]], and available scientific and technical data and information relevant to the Centre’s mission, including on preparedness, and health systems capacities to detect, prevent, respond to and recover from outbreaks of communicable diseases, complying with the rules laid down by the GDPR and the national rules in force; ;
Amendment 261 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 1
Article 5 – paragraph 1
1. The Centre shall support the networking activities of the competent bodies recognised by the Member States through the provision of coordination and technical and scientific expertise to the Commission and Member States and through the operation of the dedicated networks.
Amendment 266 #
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 ensurfacilitate the integrated operation of the network forMember States’ networks in relation to the epidemiological surveillance of the communicable diseases 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 276 #
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 integrated surveillance systems enabling real-time surveillance where appropriate, benefiting from existing EU space infrastructures and services;
Amendment 288 #
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 e
Article 5 – paragraph 2 – subparagraph 2 – point e
(e) harmonise and rationalisefacilitate the harmonisation of the operating methodologies;
Amendment 289 #
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 f
Article 5 – paragraph 2 – subparagraph 2 – point f
(f) ensurfacilitate the interoperability of automated applications, including for contact tracing, developed at national level;
Amendment 294 #
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) ensurfacilitate 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.
Amendment 295 #
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 – introductory part
Article 5 – paragraph 4 – introductory part
The Centre, through the cooperation of the networks for the epidemiological surveillance, shall:
Amendment 298 #
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) facilitate the monitoring of and report on trends in communicable diseases 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 identificationproposal of specifications for harmonised data collection from member states
Amendment 301 #
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 assessfacilitate the assessment of health systems’ capacity for diagnosis, prevention and treatment of specific communicable diseases as well as patients’ safety;
Amendment 307 #
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 e
Article 5 – paragraph 4 – point e
(e) identifyparticipate with Member States in the identification of population groups at risk and in need of targeted prevention and response measures, and ensure that those measures are accessible for persons with disabilities;
Amendment 313 #
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 g
Article 5 – paragraph 4 – point g
(g) carry out epidemiological modelling, anticipation and scenario development for response and coordinate such efforts with a view to exchange best practices and improve modelling capacity across the Union, in cooperation with the Member States; and
Amendment 315 #
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
Article 5 – paragraph 4 – point h
(h) identify, with the Member States, risk factors for disease transmission, groups most at risk, including the correlation of disease incidence and severity with societal and environmental factors, and research priorities and needs.
Amendment 318 #
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 1
Article 5 – paragraph 5 – subparagraph 1
Each Member State shall, on a voluntary basis and in compliance with subsidiarity regarding public health, designate a coordinating competent body and nominate a national focal point and operational contact points as relevant for public health functions, including epidemiological surveillance, and for various disease groups and individual diseases.
Amendment 321 #
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
Article 5 – paragraph 5 – subparagraph 3
National focal points and operational contact points nominated for disease- specific interactions with the Centre shall form disease-specific or disease-group- specific networks whose tasks shall include the transmission of national surveillance data to the Centre, in compliance with subsidiarity and the rules laid down by Regulation (EU) 2016/679 and the national rules in force.
Amendment 324 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 6
Article 5 – paragraph 6
6. The Centre shall ensurfacilitate the operation of the network of EU reference laboratories referred to in Article 15 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], for the diagnosis, detection, identification and characterisation of infectious agents that may present a threat to public health.
Amendment 327 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 8 – subparagraph 1
Article 5 – paragraph 8 – subparagraph 1
The Centre shall ensurfacilitate the operation of the network of Member State services supporting transfusion, transplantation and medically assisted reproduction to allow for continuous and rapid access to sero- epidemiological data via sero- epidemiological surveys within the population, including assessment of donor population exposure and immunity.
Amendment 330 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 8 – subparagraph 2
Article 5 – paragraph 8 – subparagraph 2
The network referred to in the first subparagraph shall support the Centre by monitoring human or animal disease outbreaks that are relevant to substances of human origin and their supply to patients, and with the development of guidelines for blood, tissues and cells safety and quality.
Amendment 333 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5 a – title
Article 5 a – title
Prevention of communicable diseases of human or animal origin
Amendment 336 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EC) No 851/2004
Article 5 a – paragraph 1
Article 5 a – paragraph 1
1. The Centre shall support Member States to strengthen their communicable disease prevention and control systems for communicable diseases of human or animal origin.
Amendment 344 #
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 developfacilitate the development of a framework for the prevention of communicable diseases and special issues, including vaccine preventable diseases, antimicrobial resistance, health education, health literacy and behaviour change.
Amendment 355 #
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 shallmay coordinate independent post-marketing vaccines effectiveness and safety monitoring studies collecting new information and/or using the relevant data collected by competent bodies. That work shall be conducted jointly with the European Medicines Agency and notably though a new vaccine monitoring platform.;
Amendment 362 #
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 b
Article 5b – paragraph 1 – subparagraph 2 – point b
(b) developfacilitate the development of preparedness monitoring and evaluation frameworks and indicators for preparedness;
Amendment 373 #
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) assessfacilitate the assessment of national health systems’ capacity 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 379 #
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 k
Article 5b – paragraph 1 – subparagraph 2 – point k
(k) maintain a regular secondment mechanisms between the Centre, the Commission and Member States’ high- level experts.;
Amendment 387 #
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, in compliance with the rules laid down by the GDPR and the national rules in force, or exchanged through digital infrastructures and applications, in accordance with data protection rules, 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 396 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EC) No 851/2004
Article 7 – paragraph 3
Article 7 – paragraph 3
3. The Centre shall issue scientific opinions within a time frame mutually agreed time framewith the requesting party.
Amendment 401 #
Proposal for a regulation
Article 1 – paragraph 1 – point 9
Article 1 – paragraph 1 – point 9
Regulation (EC) No 851/2004
Article 8 – paragraph 1
Article 8 – paragraph 1
1. The Centre shall support and assist the Commission by operating the EWRS and by ensuring with the Member States the capacity to respond in a coordinated manner, particularly in relation to health emergencies and epidemics.
Amendment 404 #
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 systems, particularly with national alert systems.
Amendment 413 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 851/2004
Article 8a– paragraph 1
Article 8a– paragraph 1
1. The Centre shall provide timely rapid risk assessments as quickly as possible, in accordance with Article 20 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1) of that Regulation including a threat to substances of human origin, such as blood, organs, tissues and cells potentially impacted by communicable diseases, or point (d) of Article 2(1) of that Regulation
Amendment 415 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 851/2004
Article 8a – paragraph 1 a (new)
Article 8a – paragraph 1 a (new)
1a. Any delay proven through modern and science-informed data in providing the risk assessment may be considered to be wrongful and may be subject to review by the courts.
Amendment 421 #
Proposal for a regulation
Article 1 – paragraph 1 – point 10
Article 1 – paragraph 1 – point 10
Regulation (EC) No 851/2004
Article 8a – paragraph 3
Article 8a – paragraph 3
3. For the purposes of paragraph 1, the Centre shall coordinate the preparation of rapid risk assessments by systematically involving Member States experts and relevant agencies, if necessary.
Amendment 453 #
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EC) No 851/2004
Article 11a – paragraph 1
Article 11a – paragraph 1
1. The Centre shall facilitate cooperation between the Member States for the establishment of 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 458 #
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 developfacilitate the development of a framework and establish procedures with the Commission to mobilise the EU Health Task Force.
Amendment 459 #
Proposal for a regulation
Article 1 – paragraph 1 – point 14
Article 1 – paragraph 1 – point 14
Regulation (EC) No 851/2004
Article 11a – paragraph 3
Article 11a – paragraph 3
3. The Centre shall help to ensure that the EU Health Task Force are coordinated and complementary to the capacities integrating the European Medical Corps and other relevant capacities under the Union Civil Protection Mechanism.
Amendment 461 #
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 facilitate the development with the Commission and the Member States of a framework for the mobilisation of the EU Health Task Force, in view of action under Decision No 1313/2013/EU*.
Amendment 469 #
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 as quickly as possible. 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.’;
Amendment 485 #
Proposal for a regulation
Article 1 – paragraph 1 – point 21
Article 1 – paragraph 1 – point 21
Regulation (EC) No 851/2004
Article 21 – paragraph 1 – subparagraph 1
Article 21 – paragraph 1 – subparagraph 1
Without prejudice to Article 20, the Centre shall not divulge to third parties confidential information that it receives for which confidential treatment has been requested and justified, except for information which must be made public, if circumstances so require, in order to protect public health. If the confidential information has been submitted by a Member State, that information cannot be disclosed without the prior consent of that Member State, in compliance with the rules laid down by the GDPR and the national rules in force.
Amendment 489 #
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 a (new)
Article 21 – paragraph 6 a (new)
6a. All members of the Centre shall be required to demonstrate full personal transparency.