34 Amendments of Michèle RIVASI related to 2020/0320(COD)
Amendment 75 #
Proposal for a regulation
Recital 5
Recital 5
(5) This Regulation accordingly expands the mission and tasks of the Centre to enhance the Centre’s capacity to provide the required robust and independent scientific expertise and to support actions which are relevant to the prevention, preparedness, response planning and combating serious cross- border threats to health in the Union in accordance with Regulation EU …/… of the European Parliament and of the Council10 [ISC/2020/12524]. __________________ 10Regulation (EU) XXXX/XXXX of the European Parliament and of the Council of DATE on serious cross-border threats to health and repealing Decision No 1082/2013/EU [OJ: please, insert full title and publication reference to Regulation on serious cross border threats to health (SCBTH).]
Amendment 83 #
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, evaluate and support 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. Such plans should include recommendations for policy interventions related to mitigation of the impact of communicable diseases on health services and care, including for non-communicable diseases. 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 91 #
Proposal for a regulation
Recital 7
Recital 7
(7) Access to timely and complete data is a precondition for the Centre to conduct rapid risk assessments, including epidemiological modelling and forecasting. To effectively support the work of the Centre and ensure the fulfilment of its mission, Member States should be tasked to communicate to the Centre data on the surveillance of communicable diseases and other special health issues such as antimicrobial resistance and healthcare- associated infections related to communicable diseases,. Member States should provide available scientific and technical data and information relevant to the Centre’s mission, to within agreed timeframes, notify the Centre of any serious cross-border threats to health, and provide information on preparedness and response planning and health system capacity, and provide relevant information that may be useful for coordinating the resp. To avoid duplication of efforts and diverging recommendationse, as well as identify recognised competent bodies and public health experts available to assist in Union responses to health threatstandardised definitions and fluid information exchange should take place between the Centre, the WHO and national agencies.
Amendment 96 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) Member States, the Commission and the Centre shall identify recognised competent bodies and public health experts, both in the areas of communicable and of non-communicable diseases, available to assist in Union responses to health threats. Such experts and stakeholders, including civil society organisations, should be structurally engaged throughout all activities of the Centre and contribute to its advice and decision-making processes. Full compliance with transparency and conflict of interest rules for stakeholder engagement should be ensured.
Amendment 100 #
Proposal for a regulation
Recital 8
Recital 8
(8) To enhance preparedness and response planning activities in the Union, the Centre’s operation of dedicated networks and networking activities should be broadened to reflect the scope of Regulation (EU) …/…. [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. To this end, the Centre should coordinate and provide technical and scientific expertise to the Commission and Member States through dedicated networks with competent coordinating bodies, including newly established networks for laboratories and for supporting transfusion, and transplantation and medically assisted reproduction,
Amendment 112 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) Due to the sensitive nature of the health data, the Centre should safeguard and guarantee its processing operations respect the data protection principles of lawfulness, fairness, transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality. With respect to the new tasks conferred to the Centre by this Regulation, the Centre should adopt specific measures for minimising risks that can emerge from the transfer of bias or incomplete data from multiple sources, as well as establish procedures for data quality review. The Centre should strictly respect the principles of data protection as set out in Article 27 of Regulation (EU) 2018/17251a, while also determining appropriate technical and organisational security measures in accordance with Article 33 thereof. __________________ 1aRegulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
Amendment 117 #
Proposal for a regulation
Recital 10
Recital 10
(10) To strengthen the capacity of the Union and Member States to assess the epidemiological situation and perform accurate risk assessment and response, the Centre should in particular monitor and report on trends in communicable diseases, support and 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, based on set indicators, 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, the WHO and public health experts, 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 142 #
Proposal for a regulation
Recital 14
Recital 14
(14) The Centre should enhance preparedness and response capabilities at national and Union level by providing independent 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 ensure the One Health approach and broaden its collection and analysis of data in terms of epidemiological surveillance and related special health and environment 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 the WHO, Union and national agencies, competent bodies and other organisations operating in the field of data collection.
Amendment 168 #
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, measures should be put in place to ensure use of anonymous data in line with the principle of data minimisation. Where anonymisation would not allow to achieve the specific purpose of the processing, the data should be pseudonymised. Where it is necessary for the purposes of this Regulation to process personal data, this should be done in accordance with Union law on the protection of personal data. Any processing of personal data based on this Regulation should take place in accordance with Regulations (EU) 2016/679 and Regulation (EU) 2018/1725.
Amendment 207 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2
Article 1 – paragraph 1 – point 2
Regulation (EC) No 851/2004
Article 3 – paragraph 2 – point b
Article 3 – paragraph 2 – point b
(b) provide analyses, scientific advice, opinions and support for actions by the Union and Member States on cross-border health threats, including risk assessments, analysis of epidemiological information, epidemiological modelling, anticipation and forecast, recommendations for actions to prevent and control communicable disease threats and other special health issues, assessment of the impact of communicable diseases on healthcare systems and care delivery, contribution to defining research priorities, and scientific and technical assistance including training and other activities within its mandate;
Amendment 212 #
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 the European networking of bodies, organisations and experts 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, while ensuring full compliance with the rules on transparency and conflicts of interest;
Amendment 230 #
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 in all languages of the Union on communicable diseases, on the threats to health posed by them and on the relevant prevention and control measures.
Amendment 248 #
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 mannerwithin agreed timeframes 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;
Amendment 254 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3
Article 1 – paragraph 1 – point 3
Regulation (EC) No 851/2004
Article 4 – paragraph 1 – point c
Article 4 – paragraph 1 – point c
(c) identify, within the scope of the mission of the Centre, recognised competent bodies and public health experts and organisations who could be made available to assist in Union responses to health threats, such as by undertaking missions to Member States to provide expert advice and field investigations in the event of disease clusters or outbreaks.;
Amendment 271 #
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; the digital platforms and applications shall be implemented with privacy-enhancing technologies taking into account the state of the art;
Amendment 277 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point b
Article 5 – paragraph 2 – subparagraph 2 – point b
(b) adopt specific measures for minimising risks that may emerge from the transfer of bias or incomplete data from multiple sources, as well as establish procedures for data quality review to provide quality assurance by monitoring and evaluating epidemiological surveillance activities (including setting surveillance standards and monitoring data completeness) of the dedicated surveillance networks to ensure optimal operation;
Amendment 286 #
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 d
Article 5 – paragraph 2 – subparagraph 2 – point d
(d) communicate the results of the analysis of data to the Commission and Member States, as well as to the public, where appropriate;
Amendment 293 #
Proposal for a regulation
Article 1 – paragraph 1 – point 4
Article 1 – paragraph 1 – point 4
Regulation (EC) No 851/2004
Article 5 – paragraph 2 – subparagraph 2 – point g
Article 5 – paragraph 2 – subparagraph 2 – point g
(g) ensure the interoperability of the digital platforms for surveillance with digital infrastructures allowing for the health data to be used for healthcare, research, policy making and regulatory purposes and with a view to integrate those platforms and infrastructures in the European Health Data Space, as regulated by Union legislation, in compliance with points (h) and (i) of Article 9(2) of Regulation (EU) 2016/679, and make use of other relevant data, for example environmental factors.
Amendment 311 #
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 ofassess the burden of communicable diseases on national health services, care delivery and the population using data, such as disease prevalence, complications, hospitalisation and mortality, and ensure that this data is disaggregated on age, gender and disability;
Amendment 328 #
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 ensure the operation of the network of Member State services supporting transfusion, and 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 364 #
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 c
Article 5b – paragraph 1 – subparagraph 2 – point c
(c) facilitate self-assessments and independent external evaluation of Member States’ preparedness and response planning, and contribute to reporting and auditing on preparedness and response planning under Articles 7 and 8 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]];
Amendment 365 #
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 c
Article 5b – paragraph 1 – subparagraph 2 – point c
(e) develop exercises, stress tests, in- action and after-action reviews and organise capacity building actions to address identified preparedness capacity and capability gaps;
Amendment 374 #
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 set indicators, 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 383 #
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 1
Article 6 – paragraph 3 – subparagraph 1
The Centre may promote and initiate scientific studies necessary for the performance of its mission and applied scientific studies and projects on the feasibility, development and preparation of its activities. The Centre shall avoid duplication with Commission’s, Member States’ and, Union and WHO research and health programmes, and will liaise between the public health and the research sector as needed.
Amendment 391 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 – point c
Article 1 – paragraph 1 – point 7 – point c
Regulation (EC) No 851/2004
Article 6 – paragraph 4
Article 6 – paragraph 4
4. The Centre shall consult with the Commission and other, relevant Union bodies or agencies, and public health experts with regard to the planning and priority setting of research and public health studies.;
Amendment 392 #
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 – introductory part
Article 7 – paragraph 1 – introductory part
The Centre shall issue an independent scientific opinion on matters falling within its mission:
Amendment 400 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EC) No 851/2004
Article 7 – paragraph 5 a (new)
Article 7 – paragraph 5 a (new)
5a. The Centre shall consult public health experts and relevant organisations, including the Advisory Forum and the WHO, before issuing a scientific opinion.
Amendment 420 #
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 involving Member States, public health experts and relevant agencies, if necessary and organisations.
Amendment 451 #
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 5 a (new)
Article 11 – paragraph 5 a (new)
5a. 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 on privacy and electronic communications, 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 455 #
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 establish capacity to mobilise and deploy the EU Health Task Force including the Centre’s staff and, experts from Member States and, fellowship programmes and international and non- profit organisations, to assist local response to outbreaks of communicable diseases in Member States and in third countries.
Amendment 467 #
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
Transparency of the Centre’s work enables the public and experts to understand the Centre’s responsibilities and to scrutinise its scientific assessment work and outputs. The Centre shall ensure that the public, healthcare professionals 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 with essential information available in all languages of the Union. It shall also publish its opinions produced in accordance with Article 6.;
Amendment 473 #
Proposal for a regulation
Article 1 – paragraph 1 – point 15 – point c
Article 1 – paragraph 1 – point 15 – point c
Regulation (EC) No 851/2004
Article 12 – paragraph 3
Article 12 – paragraph 3
3. The Centre shall cooperate as appropriate with the competent bodies in the Member States, the WHO and other interested parties with regard to public information campaigns.;
Amendment 475 #
Proposal for a regulation
Article 1 – paragraph 1 – point 16 – point b
Article 1 – paragraph 1 – point 16 – point b
Regulation (EC) No 851/2004
Article 14 – paragraph 5 – point i – subparagraph 1
Article 14 – paragraph 5 – point i – subparagraph 1
determine the rules governing the languages of the Centre, including the possibility of a distinction between the internal workings of the Centre and the external communication, taking into account the need to ensure access to, and participation in, the work of the Centre by all interested parties in both cases, as well as expert scrutiny of scientific findings and public understanding of the Centre's work and recommendations.
Amendment 480 #
Proposal for a regulation
Article 1 – paragraph 1 – point 19 – point c
Article 1 – paragraph 1 – point 19 – point c
Regulation (EC) No 851/2004
Article 18 – paragraph 8
Article 18 – paragraph 8
8. The director may inviteCentre shall structurally engage public health experts or, representatives of professional orand scientific bodies, or and non-governmental organisations, in particular with recognised experience in disciplines related to the work of the Centre to cooperate in specific t, as well as in other areas, including non- communicable diseaskes and environmental protection, to take part in the relevantall key activities of the Advisory ForumCentre, dedicated networks and the Advisory Forum and to cooperate on specific tasks. In addition, the Commission and Member States may suggest to the directorCentre experts or representatives of professional or scientific bodies, or non-governmental organizsations to be inviconsulted on an ad-hoc basis.;