Amendments adopted by the European Parliament on 14 September 2021 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 (COM(2020)0726 — C9-0366/2020 — 2020/0320(COD))
Date: 2021-09-14
Institutions: Committee on Budgets, Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: European Centre for Disease Prevention and Control, coronavirus disease, cross-border cooperation, disease prevention, epidemic, epidemiology, health control, health risk




C_2022117EN.01019201.xml










11.3.2022   


EN


Official Journal of the European Union


C 117/192






P9_TA(2021)0376
European Centre for Disease Prevention and Control ***I
Amendments adopted by the European Parliament on 14 September 2021 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 (COM(2020)0726 — C9-0366/2020 — 2020/0320(COD)) (1)

(Ordinary legislative procedure: first reading)
(2022/C 117/22)

Amendment 1


Proposal for a regulation


Recital 1








Text proposed by the Commission




Amendment











(1)


The Union is committed to protect and improve human health
, in particular to combat the
 major 
cross-border
 health scourges
, measures concerning
 monitoring, early warning of and combating serious cross-border threats to health.












(1)


The Union is committed 
as a priority
 to protect and improve human health 
through the prevention of disease and by tackling
 major health scourges 
by means of
 monitoring, 
assessing, communicating on, improving preparedness for, providing
 early warning of, and combating serious cross-border threats to health.









Amendment 2


Proposal for a regulation


Recital 2 a (new)








Text proposed by the Commission




Amendment





 










(2a)






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 identification and monitoring of the relationship between major non-communicable diseases, with a view to assessing the impact that infectious diseases have on health systems at large and the effect of comorbidities on health outcomes as observed during the COVID-19 pandemic. 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 comprehensive information on public health that can be used for policy decision-making.











Amendment 3


Proposal for a regulation


Recital 3








Text proposed by the Commission




Amendment











(3)


On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus COVID-19 outbreak a global pandemic. 
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.












(3)


On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus COVID-19 outbreak a global pandemic. 
Given
 the challenges experienced in responding to the pandemic
, in particular for people suffering from non-communicable diseases, and in view of the effectiveness gaps which have been identified in the Union’s reaction in that regard,
 it became clear that the Union’s framework for health crisis preparedness and response should be strengthened 
and extended to better use the potential of the Union's and Member States' capacities to respond to future pandemics
.









Amendment 4


Proposal for a regulation


Recital 3 a (new)








Text proposed by the Commission




Amendment





 










(3a)






The European Ombudsman's decision of 5 February 2021 in strategic inquiry OI/3/2020/TE identified some important effectiveness gaps in the Centre's response to the COVID-19 pandemic. The Centre’s information gathering system is such that it results in a lack of timely, complete and comparable data and thus affects the modelling and forecasting potential of the Centre, the level of transparency of that information and how it is communicated to the public. Those shortcomings should be addressed in this Regulation to ensure that, inter alia, there is improved coordination and epidemiological surveillance, and timely communication of the Centre’s actions and that those actions are more transparent.











Amendment 5


Proposal for a regulation


Recital 3 b (new)








Text proposed by the Commission




Amendment





 










(3b)






The capacity of the Centre to implement new tasks will depend on the level of financial assistance available from the Union, as well as on the internal and external human resources available. In order to be able to fulfil the new tasks entrusted to it as a result of the COVID-19 pandemic, the Centre will need increased funding and more employees. Such new resources cannot come to the Centre only from ad hoc project-oriented funds, such as those allocated in accordance with Regulation (EU) 2021/522 of the European Parliament and of the Council

 (1a)

(the ‘EU4Health Programme’), and the resources already allocated to the Centre in the 2021-2027 multiannual financial framework period are not sufficient. It is therefore important that the Centre’s funding and staffing be increased at the earliest opportunity.











Amendment 6


Proposal for a regulation


Recital 3 c (new)








Text proposed by the Commission




Amendment





 










(3c)






Improving overall population health through disease prevention will help to reduce susceptibility to future infectious outbreaks. Synergies should be fostered with other Union health initiatives, for instance Europe’s Beating Cancer Plan, or Union instruments, such as the EU4Health Programme.











Amendment 7


Proposal for a regulation


Recital 3 d (new)








Text proposed by the Commission




Amendment





 










(3d)






The over-exploitation of wildlife and other natural resources and the accelerated loss of biodiversity pose a risk to human health. As the health of humans, animals and the environment are inextricably linked, it is crucial to take the ‘One Health’ approach to addressing current and emerging crises.











Amendment 8


Proposal for a regulation


Recital 5








Text proposed by the Commission




Amendment











(5)


This Regulation accordingly expands the mission and tasks of the Centre to enhance the Centre’s capacity to provide the required 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 Council (10) [ISC/2020/12524].












(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
, including in relation to the impact of communicable diseases on major non-communicable diseases and especially the interconnections between them,
 in accordance with Regulation EU …/… of the European Parliament and of the Council (10) [ISC/2020/12524].









Amendment 9


Proposal for a regulation


Recital 6








Text proposed by the Commission




Amendment











(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 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.












(6)


In this respect, the Centre should be tasked with providing 
timely
 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
, as many outbreaks are of zoonotic origin
. It should monitor
, assess 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
, with a view to enabling Member States to improve their health systems' capacities. Such plans should include recommendations for policy interventions related to mitigation of the impact of communicable diseases on health services and care, in particular with regard to the situation of patients suffering from major non-communicable diseases. The monitoring of Member State health systems’ capacity should be based on common indicators and definitions in order to ensure comparability. The Centre should have a right to organise regular visits to the Member States to assess health systems' capacity to manage health crises and ad hoc inspections to the Member States to verify 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 personnel training
, 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 10


Proposal for a regulation


Recital 7








Text proposed by the Commission




Amendment











(7)


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, available scientific and technical data and information relevant to the Centre’s mission, 
to
 notify the Centre of any serious cross-border threats to health, information on preparedness and response planning and health system capacity
, and provide relevant
 information 
that may be useful for coordinating the response, as well as identify recognised competent bodies and public health experts available to assist in Union responses to health threats
.












(7)




Having access to timely and complete data is a precondition for the Centre to be able 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 communicate
, in a timely manner,
 to the Centre 
comparable and high quality
 data on the surveillance of communicable diseases
, such as HIV, viral hepatitis B and C and Tuberculosis,
 and other special health issues such as antimicrobial resistance and healthcare-associated infections 
and their impact on major non-communicable
 diseases
, including those relating to mental health. Member States should provide
 available scientific and technical data and information relevant to the Centre’s mission, notify the Centre of any serious cross-border threats to health 
and provide
 information on preparedness and response planning and health system capacity
. To avoid duplication of efforts and diverging recommendations, timelines, case definitions, indicators, standards, protocols and procedures for communications should be agreed between the Centre and the Member States and a fluid
 information 
exchange should take place between the Centre, the WHO and national agencies
.









Amendment 11


Proposal for a regulation


Recital 7 a (new)








Text proposed by the Commission




Amendment





 










(7a)






Systematic integration of the analysis and assessment of risks associated with environmental, climate and food factors with epidemiological surveillance, taking into consideration the weaknesses of national health systems and the concentration of vulnerable groups in the population, should be fostered by the Commission in collaboration with the Centre, the European Environment Agency, the European Chemicals Agency and the European Food Safety Authority, to work towards a holistic approach to the prevention and early detection of communicable diseases. Existing instruments, such as the European Climate and Health Observatory, and instruments under development, such as the European Health Emergency Preparedness and Response Authority (HERA), should be used for this purpose.











Amendment 12


Proposal for a regulation


Recital 8








Text proposed by the Commission




Amendment











(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, transplantation and medically assisted reproduction,












(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, Member States 
and the Health Security Committee (‘HSC’)
 through dedicated networks with competent coordinating bodies, including 
by encouraging cooperation within the Union's
 newly established networks for laboratories and for supporting transfusion, transplantation and medically assisted reproduction.









Amendment 13


Proposal for a regulation


Recital 9








Text proposed by the Commission




Amendment











(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.












(9)


With a view to enhance the effectiveness of epidemiological surveillance 
and monitoring of testing for and treatment
 of communicable 
diseases, their interconnection with major non-communicable
 diseases and of the related special health issues in the Union, the Centre should be tasked with the further development of 
secure and interoperable
 digital platforms and applications, supporting epidemiological surveillance at Union level, enabling the use of digital technologies, such as artificial intelligence 
and computer modelling and simulation
, 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.









Amendment 14


Proposal for a regulation


Recital 10








Text proposed by the Commission




Amendment











(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 the capacity of national health systems for diagnosis, prevention 
and
 treatment of communicable diseases, including in a gender-sensitive way, identify population groups at risk requiring specific measures, analyse the correlation of disease incidence with societal 
and
 environmental factors, and identify risk factors for transmission and disease severity of communicable diseases, and identify research needs and priorities. The Centre should work with nominated national focal points for surveillance, forming a network that strategically advises the Centre on such matters and would promote the use of enabling sectors, such as EU space data and services.












(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
, based on a set of common indicators proposed by the Centre and developed in close collaboration and consultation with Member States, identify emerging health threats,
 monitor and report on trends in communicable diseases, support
, coordinate
 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, assess 
and support Member States with the aim of achieving upward convergence of
 the capacity of national health systems for diagnosis, prevention, treatment 
and containment of the spread
 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, environmental 
and climate
 factors, 
consider the impact of comorbidities on patients with communicable diseases and on their treatment
 and identify risk factors for transmission and disease severity of communicable diseases, and identify research needs and priorities. The Centre should work with nominated national focal points for surveillance, forming a network that strategically advises the Centre on such matters and would promote the use of enabling sectors, such as EU space data and services.









Amendment 15


Proposal for a regulation


Recital 11








Text proposed by the Commission




Amendment











(11)


The Centre should help strengthen the capacity within the Union to 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.












(11)


The Centre should help strengthen the capacity within the Union to diagnose, detect, identify and characterise infectious agents which may threaten public health by ensuring the operation 
in an integrated manner of a dedicated
 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, 
training in current and innovative procedures
 and use of tests, in order to ensure uniform surveillance, notification and 
standardised
 reporting of diseases, as well as strengthened quality of testing and surveillance.









Amendment 16


Proposal for a regulation


Recital 12








Text proposed by the Commission




Amendment











(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 of national 
blood and transplant
 services and their authorities 
to serve this purpose
.












(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
, comprehensive and accurate
 risk 
assessment
 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 of national services and their authorities 
for the microbiological safety of substances of human origin (SoHO) encompassing transfusion, transplantation and assisted reproduction
.









Amendment 17


Proposal for a regulation


Recital 13








Text proposed by the Commission




Amendment











(13)


With the aim of reducing the occurrence of epidemics and strengthening capacities to prevent communicable diseases in the Union, the Centre should develop a framework for the prevention of communicable diseases, which addresses such issues as vaccine preventable diseases, antimicrobial resistance, health education, health literacy 
and
 behaviour change.












(13)


With the aim of reducing the occurrence of epidemics and strengthening capacities to prevent communicable diseases in the Union, the Centre should
, working in conjunction with Member States so as to take account of their experiences and respective situations,
 develop a framework for the prevention of communicable diseases, which addresses such issues as vaccine preventable diseases, 
vaccine hesitancy, awareness of transmission routes,
 antimicrobial resistance, health education, health literacy
, health inequalities and disease prevention,
 behaviour change 
and links with major non-communicable diseases
. 
The Centre should provide guidelines for Member States and monitor the implementation of that framework by Member States.











Amendment 18


Proposal for a regulation


Recital 14








Text proposed by the Commission




Amendment











(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 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.












(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 
preparedness and response plans
 and 
contributing 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
, including by providing training and by sharing best practices
. 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, health systems data
, and data on interconnections between communicable diseases and major non-communicable diseases
. To this end, the Centre should ensure appropriate datasets as well as the procedures to facilitate consultation and 
secure
 data transmission and access, carry out scientific and technical evaluation of prevention and control measures at Union level and work with 
the WHO, relevant Union
 agencies, competent bodies and organisations operating in the field of data collection.









Amendment 19


Proposal for a regulation


Recital 15








Text proposed by the Commission




Amendment











(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.












(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
, high performance computing, in silico clinical trials and digital twin
 technologies and interoperable and privacy-preserving digital tools, such as mobile applications, with tracing functionalities identifying at-risk individuals
, while mitigating the risks, such as those related to biased datasets, flawed system design, lack of quality data, and overdependence on automated decision-making, and taking into account the importance of establishing safeguards to mitigate those risks during the design and implementation phases of artificial intelligence technologies.











Amendment 20


Proposal for a regulation


Recital 16








Text proposed by the Commission




Amendment











(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 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.












(16)


The Centre should establish appropriate capacities to support international
, interregional
 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 
and collect field data
. The Centre should therefore ensure 
permanent
 capacity to carry out missions to Member States 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 21


Proposal for a regulation


Recital 17








Text proposed by the Commission




Amendment











(17)


To assist responses to outbreaks, which may spread within or to the Union, the Centre is to develop a 
framework for the mobilisation the
 EU Health Task Force in accordance with Decision No 1313/2013/EU of the European Parliament and of the Council (11) and facilitate the participation of Union field response experts in international response teams in support of the Union Civil Protection Mechanism. The Centre should enhance the capability of its staff as well as experts from Union and EEA countries, candidate countries and potential candidates, as well as European Neighbourhood Policy countries and EU partner countries as referred to in Regulation (EU) No 233/2014 of the European Parliament and of the Council (12), to effectively participate in field missions and crisis management.












(17)


To assist responses to outbreaks, which may spread within or to the Union, the Centre is to develop a 
permanent
 EU Health Task Force 
and a framework for its mobilisation
 in accordance with Decision No 1313/2013/EU of the European Parliament and of the Council (11) and facilitate the participation of Union field response experts in international response teams in support of 
and in close coordination with
 the Union Civil Protection Mechanism. The Centre should enhance the capability of its staff as well as experts from Union and EEA countries, candidate countries and potential candidates, as well as European Neighbourhood Policy countries and EU partner countries as referred to in Regulation (EU) No 233/2014 of the European Parliament and of the Council (12), to effectively participate in field missions and crisis management. 
Therefore, the Centre should develop a framework of recognisable expertise levels.











Amendment 22


Proposal for a regulation


Recital 17 a (new)








Text proposed by the Commission




Amendment





 










(17a)






Member States, the Commission and the Centre should identify recognised competent bodies and public health experts, both in the areas of communicable and 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 advisory and decision-making processes. Full compliance with transparency and conflict of interest rules for stakeholder engagement should be ensured.











Amendment 23


Proposal for a regulation


Recital 17 b (new)








Text proposed by the Commission




Amendment





 










(17b)






In order to build a strong European Health Union, the Centre should facilitate the increased cooperation and the exchange of best practices with other Union institutions and agencies, including the future HERA, and ensure coordination of approaches as well as minimise duplication of efforts.











Amendment 24


Proposal for a regulation


Recital 17 c (new)








Text proposed by the Commission




Amendment





 










(17c)






The Centre should work in close cooperation with the competent bodies and the international organisations in the field of public health in particular the WHO.











Amendment 25


Proposal for a regulation


Recital 17 d (new)








Text proposed by the Commission




Amendment





 










(17d)






The Centre should communicate in an effective and transparent manner about current and emerging health risks to the general public. The Centre should publish in a timely manner 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 of 5 February 2021 in strategic inquiry OI/3/2020/TE.











Amendment 26


Proposal for a regulation


Recital 17 e (new)








Text proposed by the Commission




Amendment





 










(17e)





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 27


Proposal for a regulation


Recital 18








Text proposed by the Commission




Amendment











(18)


In order to assess the effectiveness and efficiency of the legal provisions applicable to the Centre, it is appropriate to provide for 
a regular
 Commission evaluation of the performance of the Centre.












(18)


In order to assess the effectiveness and efficiency of the legal provisions applicable to the Centre, it is appropriate to provide for 
an annual
 Commission evaluation of the performance of the Centre.









Amendment 28


Proposal for a regulation


Recital 19








Text proposed by the Commission




Amendment











(19)


This Regulation should not confer any regulatory powers on the Centre.












(19)


This Regulation should not confer any regulatory powers on the Centre. 
However, the Centre should exercise broad coordination competences and the power to provide recommendations at Union, national and interregional level in the form of clear and uniform science-based proposals.











Amendment 29


Proposal for a regulation


Recital 20 a (new)








Text proposed by the Commission




Amendment





 










(20a)






Due to the sensitive nature of health data, the Centre should safeguard and guarantee that 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 on 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) 2018/1725 of the European Parliament and of the Council

 (1a)

, while also determining appropriate technical and organisational security measures in accordance with Article 33 of that Regulation.











Amendment 30


Proposal for a regulation


Recital 20 b (new)








Text proposed by the Commission




Amendment





 










(20b)






The European Data Protection Supervisor should be responsible for monitoring and ensuring the application of the provisions of this Regulation relating to the protection of fundamental rights and freedoms of natural persons with regard to the processing of personal data by the Centre, and for advising the Centre and data subjects on all matters concerning the processing of personal data. 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 the specific purpose of the processing to be achieved, the data should be pseudonymised. Where it is necessary for the purposes of this Regulation to process personal data, such processing 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 Regulation (EU) 2016/679 of the European Parliament and of the Council

 (1a)

, Regulation (EU) 2018/1725 and Directive 2002/58/EC of the European Parliament and of the Council

 (1b)

. This Regulation should be without prejudice to the obligations of Member States under Regulation (EU) 2016/679 and Directive 2002/58/EC.











Amendment 31


Proposal for a regulation


Recital 20 c (new)








Text proposed by the Commission




Amendment





 










(20c)






In order to comply with relevant data protection legislation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of setting out the categories of data subjects within the scope of the processing and the categories of the personal data processed, together with a description of the specific measures to safeguard the rights and freedoms of the data subjects involved. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making

 (1a)

. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.











Amendment 32


Proposal for a regulation


Recital 22








Text proposed by the Commission




Amendment











(22)


Since the objectives of this Regulation to expand the mission and tasks of the Centre in order to enhance the Centre’s capacity to provide the required scientific expertise and to support actions which combat serious cross-border threats to health in the Union cannot be sufficiently achieved by the Member States but can rather, by reason of the cross-border nature of the health threats and the need for rapid, coordinated and coherent response, be achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.












(22)


Since the objectives of this Regulation to expand the mission and tasks of the Centre in order to enhance the Centre’s capacity to provide the required scientific expertise and to support actions which combat serious cross-border threats to health in the Union cannot be sufficiently achieved by the Member States but can rather, by reason of the cross-border nature of the health threats and the need for rapid, 
better
 coordinated and coherent response 
to new emerging health threats
, be achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.









Amendment 33


Proposal for a regulation


Article 1 — paragraph 1 — point 1

Regulation (EC) No 851/2004
Article 2 — paragraph 1 — point 1 a (new)







Text proposed by the Commission




Amendment





 










(1a)





‘prevention and control of human disease’ means the range of recommendations issued by and measures taken by the competent public health authorities in the Member States and the Union, such as the Centre, to prevent and stop the spread of disease;










Amendment 34


Proposal for a regulation


Article 1 — paragraph 1 — point 1

Regulation (EC) No 851/2004
Article 2 — paragraph 1 — point 3







Text proposed by the Commission




Amendment











(3)


‘dedicated network’ means any specific network on diseases, special health issues or public health functions to ensure collaboration between the coordinating competent bodies of the Member States;












(3)


‘dedicated network’ means any specific network on diseases, special health issues or public health functions 
that is supported and coordinated by the Centre and is intended
 to ensure collaboration between the coordinating competent bodies of the Member States;









Amendment 35


Proposal for a regulation


Article 1 — paragraph 1 — point 1

Regulation (EC) No 851/2004
Article 2 — paragraph 1 — point 4 a (new)







Text proposed by the Commission




Amendment





 










(4a)





‘major non-communicable disease’ means a life-threatening or 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 36


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 1 — subparagraph 1







Text proposed by the Commission




Amendment





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 provide recommendations 
for
 response at Union and national levels, as well as at regional level, 
if necessary
.


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 
relevant major non-communicable diseases and health issues, including the
 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, report 
and, where appropriate, ensure that information is presented in an easily accessible way
 on current and emerging threats to human health from communicable diseases 
and relevant major non-communicable diseases and health issues in collaboration with competent bodies of the Member States or on its own initiative
, 
through the dedicated network,
 and provide recommendations 
and support in coordinating the
 response at Union and national levels, as well as at 
interregional and
 regional level, 
where appropriate
. 
In providing such recommendations, the Centre shall take into account existing national crisis management plans and the respective circumstances of each Member State.







Amendment 37


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 1 — subparagraph 2







Text proposed by the Commission




Amendment





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 
body
 upon request 
from that body
.


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 in cooperation with the competent 
bodies
 upon 
their
 request 
and provide a risk assessment
.





Amendment 38


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 1 — subparagraph 3







Text proposed by the Commission




Amendment





In pursuing its mission, the Centre shall take full account of the responsibilities of the Member States, the Commission and other Union bodies or agencies, and of the responsibilities of international organisations active within the field of public health, in order to ensure comprehensiveness, coherence and complementarity of action.


In pursuing its mission, the Centre shall take full account of the responsibilities 
and competences
 of the Member States, the Commission and other Union bodies or agencies, and of the responsibilities of international organisations active within the field of public health, in order to ensure 
coordination,
 comprehensiveness, coherence
, consistency
 and complementarity of action.





Amendment 39


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — introductory part







Text proposed by the Commission




Amendment






2.   The Centre shall, within its 
financial capacity and
 mandate, perform the following tasks:




2.   The Centre shall, within its mandate, perform the following tasks:






Amendment 40


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point a







Text proposed by the Commission




Amendment











(a)


search for, collect, collate, evaluate and disseminate relevant scientific and technical data and information, 
considering
 the latest technologies;












(a)


search for, collect, collate, evaluate and disseminate relevant scientific and technical data and information, 
taking into account
 the latest 
available
 technologies
, including artificial intelligence
;









Amendment 41


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point a a (new)







Text proposed by the Commission




Amendment





 










(aa)






develop in close collaboration and consultation with Member States relevant common indicators for standardised data collection procedures, risk assessments and supporting upwards convergence of the management of communicable diseases by Member States;











Amendment 42


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point a b (new)







Text proposed by the Commission




Amendment





 










(ab)






in close collaboration and consultation with Member States, establish timelines and procedures for exchange of the information on major non-communicable diseases referred to in point (ha) and necessary indicators to assess the impacts referred to in that point;











Amendment 43


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point b







Text proposed by the Commission




Amendment











(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, 
contribution
 to defining research priorities
, and scientific and technical assistance including training and other activities within its mandate
;












(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, 
including possible severe impacts on patients suffering from major non-communicable diseases, and contributions with regard
 to defining research priorities;









Amendment 44


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point b a (new)







Text proposed by the Commission




Amendment





 










(ba)






identify and monitor the impact of major non-communicable diseases on the incidence, severity and mortality rates of communicable diseases;











Amendment 45


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point c







Text proposed by the Commission




Amendment











(c)


coordinate the 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;












(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 46


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point d







Text proposed by the Commission




Amendment











(d)


exchange information, expertise and best practice;












(d)


exchange information, expertise and best practice
, as well as provide scientific and technical assistance, including training
;









Amendment 47


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point e







Text proposed by the Commission




Amendment











(e)


monitor health systems’ capacity relevant to the management of communicable disease threats and other special health issues;












(e)


monitor health systems’ capacity relevant to the management of communicable disease threats and other special health issues
, based on the common indicators referred to in point (aa) of this paragraph and the elements set out in Article 7(1) of Regulation (EU) …/… [the SCBTH Regulation]; the Centre shall organise regular visits to Member States to assess on the spot their health systems’ capacity referred to in the first part of this point and exchange information with the competent authorities to manage health crises
;









Amendment 48


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point e a (new)







Text proposed by the Commission




Amendment





 










(ea)






organise inspections at source in the Member States, on a case-by-case basis, to provide additional support and monitor progress in implementation of and compliance with the obligations set out in Article 5b of this Regulation, if necessary in light of the results of stress tests referred to in Article 5(5) of Regulation (EU) …/… [the SCBTH Regulation]; the results of the inspection in a Member State shall be submitted in a report to the Commission, the European Parliament, the Council and relevant Union agencies;











Amendment 49


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point e b (new)







Text proposed by the Commission




Amendment





 










(eb)






support national monitoring of the response to major communicable diseases in order to measure progress in tackling them across the Union;











Amendment 50


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point f







Text proposed by the Commission




Amendment











(f)


facilitate the development and implementation of actions, funded by relevant Union funding programmes and instruments, including the implementation of joint actions;












(f)


facilitate the development and implementation of actions, funded by relevant Union funding programmes and instruments, including the implementation of joint actions 
in the area of health
;









Amendment 51


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point g







Text proposed by the Commission




Amendment











(g)


provide, upon request of the Commission or the 
HSC,
 or its own initiative, guidelines 
for
 treatment and case management of communicable diseases and other special health issues relevant for public health, in cooperation with relevant 
societies
;












(g)


provide, upon request of the Commission or the 
Health Security Committee (‘HSC’) established under Article 4 of Regulation (EU) …/… [the SCBTH Regulation],
 or 
on
 its own initiative, guidelines
, recommendations and proposals for coordinated action for surveillance, monitoring, diagnosis,
 treatment and case management of communicable diseases and other special health issues relevant for public health, 
such as major non-communicable diseases, including
 in cooperation with relevant 
organisations with experience and expertise in treatment and case management of those diseases and health issues, while avoiding any duplication of existing guidelines, except in cases where it is necessary to update such guidelines if new scientific data become available
;









Amendment 52


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point h







Text proposed by the Commission




Amendment











(h)


support epidemic and outbreak response in Member States, and in third countries, in complementarity with other Union emergency response instruments, in particular the Union Civil protection mechanism;












(h)


support epidemic and outbreak response in Member States, and in third countries, in complementarity 
and close coordination
 with other Union emergency response instruments, in particular the Union Civil protection mechanism
, by providing recommendations on the stockpiling of medical countermeasures in cooperation with the European Medicines Agency (EMA) and other relevant Union agencies and bodies
;









Amendment 53


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point h a (new)







Text proposed by the Commission




Amendment





 










(ha)






collect information, within its existing infrastructure, on major non-communicable diseases, in particular those whose development and treatment are impacted significantly by pandemics, such as cancer, diabetes or mental illness;











Amendment 54


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point j







Text proposed by the Commission




Amendment











(j)


provide, upon request of the Commission 
or the Health Security Committee (‘HSC’)
, evidence-based communication messages to the public on communicable diseases, on the threats to health posed by them and on the relevant prevention and control measures.












(j)


provide, upon request of the Commission
, the HSC
, 
or on its own initiative, timely, easily accessible and
 evidence-based communication messages to the public 
in all official languages of the Union
 on communicable diseases, on the threats to health posed by them
, on their possible impact on patients suffering from major non-communicable diseases,
 and on the relevant prevention and control measures;









Amendment 55


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 2 — point j a (new)







Text proposed by the Commission




Amendment





 










(ja)






establish and continually update a publicly available database with recognised national competent bodies and their public health experts that act within the scope of the mission of the Centre, with relevant data provided by Member States.











Amendment 56


Proposal for a regulation


Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004
Article 3 — paragraph 3







Text proposed by the Commission




Amendment






3.   The Centre, the Commission, the relevant Union bodies or EU agencies and the Member States shall cooperate to promote effective coherence between their respective activities.




3.   The Centre, the Commission, the relevant Union bodies or EU agencies and the Member States shall cooperate 
in full transparency
 to promote effective coherence between their respective activities.






Amendment 57


Proposal for a regulation


Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004
Article 4 — paragraph 1 — introductory part







Text proposed by the Commission




Amendment





Member States shall:


Member States shall 
ensure the coordination and collaboration with the Centre in relation to all the missions and tasks set out in Article 3, by
:





Amendment 58


Proposal for a regulation


Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004
Article 4 — paragraph 1 — point a







Text proposed by the Commission




Amendment











(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;












(a)


communicate 
regularly
 to the Centre according to agreed 
timelines,
 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 59


Proposal for a regulation


Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004
Article 4 — paragraph 1 — point a a (new)







Text proposed by the Commission




Amendment





 










(aa)






use the indicators referred to in Article 3(2) to assess their domestic health situation and communicate them to the Centre to allow data to be compared;











Amendment 60


Proposal for a regulation


Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004
Article 4 — paragraph 1 — point b







Text proposed by the Commission




Amendment











(b)


notify the Centre of any serious cross-border threats to health, as soon as detected, through the Early Warning and Response System (EWRS), and promptly communicate response measures taken, as well as any relevant information that may be useful for coordinating the response as referred to in Article 21 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]]; 
and














(b)


notify the Centre of any serious cross-border threats to health, as soon as detected, through the Early Warning and Response System (EWRS), and promptly communicate response measures taken, as well as any relevant information that may be useful for coordinating the response as referred to in Article 21 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]];









Amendment 61


Proposal for a regulation


Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004
Article 4 — paragraph 1 — point c







Text proposed by the Commission




Amendment











(c)


identify, within the scope of the mission of the Centre, recognised competent bodies 
and
 public health experts 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.












(c)


identify, within the scope of the mission of the Centre, recognised competent bodies, 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 cross-border regions or to third countries
 to provide expert advice and field investigations in the event of disease clusters or outbreaks.









Amendment 62


Proposal for a regulation


Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004
Article 4 — paragraph 1 — point c a (new)







Text proposed by the Commission




Amendment





 










(ca)






develop national preparedness and response plans in accordance with Article 6 of Regulation (EU) …/… [the SCBTH Regulation], 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 that Regulation;











Amendment 63


Proposal for a regulation


Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004
Article 4 — paragraph 1 — point c b (new)







Text proposed by the Commission




Amendment





 










(cb)






facilitate the digitalisation of data collection and the data communication process between the national and the Union surveillance systems while ensuring the financial means to provide timely delivery of the necessary information; and











Amendment 64


Proposal for a regulation


Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004
Article 4 — paragraph 1 — point c c (new)







Text proposed by the Commission




Amendment





 










(cc)






immediately notify any delay in the reporting of the data to the Centre with an explanation therefore and a planned date of submission.











Amendment 65


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 1







Text proposed by the Commission




Amendment






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.




1.   The Centre shall support 
and continuously develop
 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 66


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 2 — subparagraph 1







Text proposed by the Commission




Amendment





The Centre shall ensure the integrated operation of the network for 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]].


The Centre shall ensure the integrated operation of the network for the epidemiological surveillance of communicable diseases and of special health issues
, such as an unpredicted rise in major non-communicable diseases or chronic conditions and in health-related environmental hazards, including those
 referred to in 
point
 (ii) of point (a) of Article 2(1) of Regulation (EU)…/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]].





Amendment 67


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 2 — subparagraph 2 — point a







Text proposed by the Commission




Amendment











(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;












(a)


ensure the 
continuous
 development of the digital platforms and applications
, including the platform for surveillance established under Article 14 of Regulation (EU) …/… [the SCBTH Regulation],
 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, 
and proving the necessity and proportionality of data collection and use following a data protection impact assessment (‘DPIA’),
 benefiting from existing EU 
digital
 space infrastructures and services
, with the aim of simplifying the data exchange process and reducing the administrative burden at Union and Member State levels
; 
those digital platforms and applications shall be implemented with data protection by design and by default pursuant to Article 27 of Regulation (EU) 2018/1725 of the European Parliament and of the Council

 (*1)

, taking into account current state-of-the-art technologies;











Amendment 68


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 2 — subparagraph 2 — point b







Text proposed by the Commission




Amendment











(b)


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;












(b)


provide quality assurance by monitoring and evaluating epidemiological surveillance activities (including setting surveillance standards and monitoring data completeness 
and assessment indicators
) of the dedicated surveillance networks to ensure optimal operation;









Amendment 69


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 2 — subparagraph 2 — point c







Text proposed by the Commission




Amendment











(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;












(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 order to produce comparable Union-wide data as a basis for decision-making
; 
in carrying out that 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 70


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 2 — subparagraph 2 — point c a (new)







Text proposed by the Commission




Amendment





 










(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 71


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 2 — subparagraph 2 — point d







Text proposed by the Commission




Amendment











(d)


communicate the results of the analysis of data to the Commission and Member States;












(d)


communicate the results of the analysis of data to the Commission and Member States 
and propose communications to inform the public
;









Amendment 72


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 2 — subparagraph 2 — point g







Text proposed by the Commission




Amendment











(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, and make use of other relevant data, for example environmental factors.












(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
, in compliance with points (h) and (i) of Article 9(2) of Regulation (EU) 2016/679 of the European Parliament and of the Council

 (*2)

, after having conducted a DPIA and having mitigated any risks to the rights and freedoms of the data subjects,
 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 
or phenomena with a potential severe health impact at Union or interregional level
.









Amendment 73


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 3







Text proposed by the Commission




Amendment






3.   The Centre shall support the work of the HSC, the Council and other Union structures for coordinating responses to serious cross-border threats to health within its mandate.




3.   The Centre shall support the work of the HSC, the Council and
, where relevant,
 other Union structures for coordinating responses to serious cross-border threats to health within its mandate.






Amendment 74


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 4 — point a







Text proposed by the Commission




Amendment











(a)


monitor 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 identification of specifications for harmonised data collection from member states












(a)


monitor and report on trends in communicable diseases 
and their interconnection with major non-communicable diseases and chronic conditions and implications for patients with such diseases and conditions
 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 identification of specifications for harmonised data collection from member states;









Amendment 75


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 4 — point d







Text proposed by the Commission




Amendment











(d)


monitor and assess health systems’ capacity for diagnosis, prevention and treatment of specific communicable diseases as well as patients’ safety;












(d)


monitor and assess health systems’ capacity for diagnosis, prevention and treatment of specific communicable diseases as well as patients’ safety 
and the resilience of the national health systems in the event of major disease outbreaks, based on common indicators and definitions
;









Amendment 76


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 4 — point f







Text proposed by the Commission




Amendment











(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;












(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
, and patients’ comorbidities
;









Amendment 77


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 4 — point h







Text proposed by the Commission




Amendment











(h)


identify 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.












(h)


identify risk factors for disease transmission, groups most at risk, including the correlation of disease incidence and severity with societal, environmental 
and climatic
 factors, and research priorities and needs.









Amendment 78


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 5 — subparagraph 1







Text proposed by the Commission




Amendment





Each Member State shall 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.


Each Member State shall 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. 
National focal points shall, to the greatest extent possible, be the same as the National IHR Focal Points, in order to minimise the duplication of resources and efforts.







Amendment 79


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 5 — subparagraph 3







Text proposed by the Commission




Amendment





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.


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 
as well as proposals for the prevention and control of communicable diseases
 to the Centre.





Amendment 80


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 6







Text proposed by the Commission




Amendment






6.   The Centre shall ensure 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.




6.   The Centre shall ensure 
and coordinate
 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
, genetic sequencing
 and characterisation of infectious agents that may present a threat to public health.






Amendment 81


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 6 a (new)







Text proposed by the Commission




Amendment





 





6a.
   
The Centre shall provide technical and scientific assistance to Member States to develop their detection and sequencing capacities, especially assisting those Member States that do not have sufficient capacities.








Amendment 82


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 8 — subparagraph 1







Text proposed by the Commission




Amendment





The Centre shall ensure 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.


The Centre shall ensure the operation 
and coordination
 of the network of Member State services supporting 
the microbiological safety of substances of human origin encompassing
 transfusion, transplantation and medically assisted reproduction 
established under Article 16 of Regulation (EU) …/… [the SCBTH Regulation]
 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 83


Proposal for a regulation


Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004
Article 5 — paragraph 8 — subparagraph 2







Text proposed by the Commission




Amendment





The network referred to in the first subparagraph shall support the Centre by monitoring 
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.


The network referred to in the first subparagraph shall support the Centre by monitoring outbreaks 
of communicable diseases
 that are relevant to 
the safety and sufficiency of the supply of
 substances of human origin to patients, and with the development of guidelines for blood, tissues and cells safety and quality.





Amendment 84


Proposal for a regulation


Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004
Article 5a — paragraph 1







Text proposed by the Commission




Amendment






1.   The Centre shall support Member States to strengthen their communicable disease prevention and control 
systems
.




1.   The Centre shall support Member States to strengthen their communicable disease prevention and control 
capacities, and to improve and facilitate the data collection process with real-time and interoperable sharing of data
.






Amendment 85


Proposal for a regulation


Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004
Article 5a — paragraph 2







Text proposed by the Commission




Amendment






2.   The Centre shall develop a framework for the prevention of communicable diseases and special issues, including vaccine preventable diseases, antimicrobial resistance, health education, health literacy and behaviour change.




2.   
In close collaboration with Member States, EMA and other relevant Union bodies and agencies, as well as with international organisations,
 the Centre shall develop a framework for the prevention of communicable diseases and special issues, including 
socio-economic risk factors,
 vaccine preventable diseases, antimicrobial resistance, health 
promotion, health
 education, health literacy and behaviour change.






Amendment 86


Proposal for a regulation


Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004
Article 5a — paragraph 2 — subparagraph 1 a (new)







Text proposed by the Commission




Amendment





 




That framework shall facilitate permanent consultation of representatives of civil society and industry, in particular scientific bodies, in relation to the activities of the Centre aimed at the prevention of communicable diseases, fighting against misinformation regarding vaccination and which causes vaccine hesitancy, preventive measures and medical treatment, as well as information campaigns regarding the links between disease areas and regarding the risks for patients with major non-communicable diseases.







Amendment 87


Proposal for a regulation


Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004
Article 5a — paragraph 3







Text proposed by the Commission




Amendment






3.   The Centre shall evaluate and monitor communicable disease prevention and control programmes in order to provide the evidence for recommendations to strengthen and improve these programmes at the national and Union level, and where appropriate at the international levels.




3.   The Centre 
may, upon request, provide guidelines for the creation of communicable disease prevention and control programmes, and
 shall evaluate and monitor communicable disease prevention and control programmes in order to provide the evidence for recommendations to 
coordinate,
 strengthen and improve these programmes at the national
, interregional
 and Union level, and where appropriate at the international levels.






Amendment 88


Proposal for a regulation


Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004
Article 5a — paragraph 3 a (new)







Text proposed by the Commission




Amendment





 





3a.
   
The Centre shall develop a platform to monitor the level of vaccination coverage by Member States, taking into account the specificities of the vaccination schemes at national and regional levels.








Amendment 89


Proposal for a regulation


Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004
Article 5b — paragraph 1 — subparagraph 1







Text proposed by the Commission




Amendment





The Centre shall provide scientific and technical expertise to the Member States and the Commission in collaboration with relevant Union bodies and agencies 
and
 international organisations in accordance with appropriate working arrangements established with the Commission in the field of preparedness and response planning.


The Centre shall provide 
recommendations and
 scientific and technical expertise to the Member States and the Commission in collaboration with relevant Union bodies and agencies, international organisations 
and representatives of civil society
 in accordance with appropriate working arrangements established with the Commission in the field of preparedness and response planning.





Amendment 90


Proposal for a regulation


Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004
Article 5b — paragraph 1 — subparagraph 2 — point c







Text proposed by the Commission




Amendment











(c)




facilitate self-assessments and 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]];












(c)




assess
 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]]; 
the Centre shall send its assessment with recommendations to the Member State and shall make it public;











Amendment 91


Proposal for a regulation


Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004
Article 5b — paragraph 1 — subparagraph 2 — point e







Text proposed by the Commission




Amendment











(e)


develop exercises, in-action and after-action reviews and organise capacity building actions to address identified preparedness capacity and capability gaps;












(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 92


Proposal for a regulation


Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004
Article 5b — paragraph 1 — subparagraph 2 — point f







Text proposed by the Commission




Amendment











(f)


develop specific preparedness activities addressing vaccine preventable diseases, antimicrobial resistance, laboratory capacity and biosecurity in accordance with Commission priorities and based upon gaps identified;












(f)


develop specific preparedness activities addressing
, amongst other things,
 vaccine preventable diseases, antimicrobial resistance, laboratory capacity and biosecurity in accordance with Commission priorities and based upon gaps identified;









Amendment 93


Proposal for a regulation


Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004
Article 5b — paragraph 1 — subparagraph 2 — point h







Text proposed by the Commission




Amendment











(h)


develop targeted activities addressing at-risk groups and community preparedness;












(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 94


Proposal for a regulation


Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004
Article 5b — paragraph 1 — subparagraph 2 — point i







Text proposed by the Commission




Amendment











(i)


assess 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;












(i)


assess health systems’ capacity 
based on common indicators
 to detect, prevent, respond to and recover from outbreaks of communicable diseases 
and related health risks
, identify gaps and provide recommendations for the strengthening of health systems, 
in particular as regards minimum testing capacities,
 to be implemented with Union support as appropriate; 
the Centre shall send its assessment with recommendations to the Member State and shall make it public;











Amendment 95


Proposal for a regulation


Article 1 — paragraph 1 — point 7 — point a

Regulation (EC) No 851/2004
Article 6 — paragraph 1a







Text proposed by the Commission




Amendment






1a.   The Centre shall provide concrete analyses and recommendations for actions to prevent and control communicable 
disease
 threats upon request of the Commission.




1a.   The Centre shall provide concrete analyses and recommendations for actions to prevent and control communicable 
diseases and other cross-border
 threats 
to health
 upon request of the Commission.






Amendment 96


Proposal for a regulation


Article 1 — paragraph 1 — point 7 — point b

Regulation (EC) No 851/2004
Article 6 — paragraph 3 — subparagraph 1







Text proposed by the Commission




Amendment





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 research and health programmes, and will liaise between the public health and the research sector 
as needed
.


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’, Union 
and WHO
 research and health programmes, and will liaise between the public health and the research sector 
by encouraging consultation of, and cooperation with, public health experts
.





Amendment 97


Proposal for a regulation


Article 1 — paragraph 1 — point 7 — point b

Regulation (EC) No 851/2004
Article 6 — paragraph 3 — subparagraph 2







Text proposed by the Commission




Amendment





To carry out the studies referred to in the first paragraph, the Centre shall have access to health data made available or exchanged through digital infrastructures and applications, in accordance with data protection rules, 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.


To carry out the studies referred to in the first paragraph, the Centre shall have access to health data made available or exchanged through digital infrastructures and applications, in accordance with data protection rules, allowing for the health data to be 
solely
 used for healthcare, 
health
 research, policy making and regulatory purposes 
in the domain of health
. 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
, after it has proven the necessity and proportionality of using those data
.





Amendment 98


Proposal for a regulation


Article 1 — paragraph 1 — point 7 — point b

Regulation (EC) No 851/2004
Article 6 — paragraph 3 a (new)







Text proposed by the Commission




Amendment





 





3a.
   
The Centre may use its resources and make use of reference laboratories, in order to perform field research, data gathering and data analysis, to help relevant national bodies gather reliable data.








Amendment 99


Proposal for a regulation


Article 1 — paragraph 1 — point 7 — point c

Regulation (EC) No 851/2004
Article 6 — paragraph 4







Text proposed by the Commission




Amendment






4.   The Centre shall consult with the Commission and other Union bodies or agencies with regard to the planning and priority setting of research and public health studies.




4.   The Centre shall consult with the Commission
, the HSC
 and other 
relevant
 Union bodies or agencies with regard to the planning and priority setting of research and public health studies.






Amendment 100


Proposal for a regulation


Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004
Article 7 — paragraph 1 — point c







Text proposed by the Commission




Amendment











(c)


at the request of the Commission; 
and














(c)


at the request of the Commission 
or EMA
;









Amendment 101


Proposal for a regulation


Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004
Article 7 — paragraph 1 — point c a (new)







Text proposed by the Commission




Amendment





 










(ca)






at the request of the HSC; and











Amendment 102


Proposal for a regulation


Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004
Article 7 — paragraph 2







Text proposed by the Commission




Amendment






2.   Requests for a scientific opinion referred to in paragraph 1 shall clearly explain the scientific issue to be addressed and the Union interest and be accompanied by sufficient background information regarding that issue.




2.   Requests for a scientific opinion referred to in paragraph 1 shall clearly explain the scientific issue to be addressed and the Union interest and 
necessity to act, and shall
 be accompanied by sufficient background information regarding that issue.






Amendment 103


Proposal for a regulation


Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004
Article 7 — paragraph 4







Text proposed by the Commission




Amendment






4.   Where different requests are made on the same issue or where the request does not comply with paragraph 2, the Centre may decline to issue a scientific opinion or propose amendments to that request in consultation with the institution or Member State that made the request. In case the request is declined, a justification shall be given to the institution or Member States that made the request.




4.   Where different requests are made on the same issue or where the request does not comply with paragraph 2, the Centre may decline to issue a scientific opinion or propose amendments to that request in consultation with the institution
, agency
 or Member State that made the request. In case the request is declined, a justification shall be given to the institution
, agency
 or Member States that made the request.






Amendment 104


Proposal for a regulation


Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004
Article 7 — paragraph 5







Text proposed by the Commission




Amendment






5.   Where the Centre has already delivered a scientific opinion on the specific issue covered by a request and it concludes that no scientific elements justify the re-examination of the issue, information supporting that conclusion shall be given to the institution or Member State that made the request.




5.   Where the Centre has already delivered a scientific opinion on the specific issue covered by a request and it concludes that no scientific elements justify the re-examination of the issue, information supporting that conclusion shall be given to the institution
, agency
 or Member State that made the request.






Amendment 105


Proposal for a regulation


Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004
Article 8 — paragraph 1







Text proposed by the Commission




Amendment






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.




1.   The Centre shall support and assist the Commission by operating the EWRS 
provided for in Article 18 of Regulation (EU) …/… [the SCBTH Regulation]
 and by ensuring with the Member States the capacity to respond in a coordinated 
and timely
 manner.






Amendment 106


Proposal for a regulation


Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004
Article 8 — paragraph 2 — point b







Text proposed by the Commission




Amendment











(b)


provide information, expertise, advice and risk assessment to Member States and the Commission; and












(b)


provide information, expertise, advice
, training
 and risk assessment to Member States and the Commission; and









Amendment 107


Proposal for a regulation


Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004
Article 8 — paragraph 2 a (new)







Text proposed by the Commission




Amendment





 





2a.
   
The Centre shall work with the Commission, the HSC and Member States to improve the reporting of relevant data through the EWRS, aiming to digitalise that process and integrate it into national surveillance systems.








Amendment 108


Proposal for a regulation


Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004
Article 8 — paragraph 3







Text proposed by the Commission




Amendment






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.




3.   The Centre shall work with the Commission and the HSC on the EWRS 
continuous
 updates, including for the use of modern technologies, such as digital mobile applications, artificial intelligence 
and computer modelling and simulation
 models, or other technologies for automated contact tracing, building upon the contact tracing technologies developed by the Member States. 
Those technologies shall be used for the sole purpose of fighting pandemics, where proven to be adequate, necessary and proportionate, and in full compliance with Regulation (EU) 2016/679 and Directive 2002/58/EC of the European Parliament and of the Council

 (*3)

,
 and on defining the functional requirements of the EWRS.






Amendment 109


Proposal for a regulation


Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004
Article 8 — paragraph 5







Text proposed by the Commission




Amendment






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

 (*4)





5.   The Centre 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 and 36 of Regulation (EU) 2018/1725.






Amendment 110


Proposal for a regulation


Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004
Article 8a — paragraph 1







Text proposed by the Commission




Amendment






1.   The Centre shall provide timely 
rapid
 risk assessments, 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




1.   The Centre shall provide timely risk assessments, 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 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 111


Proposal for a regulation


Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004
Article 8a — paragraph 1 a (new)







Text proposed by the Commission




Amendment





 





1a.
   
The risk assessments referred to in paragraph 1 shall be carried out in a timely manner and in as short a period of time as possible in order to gather the necessary information.








Amendment 112


Proposal for a regulation


Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004
Article 8a — paragraph 2







Text proposed by the Commission




Amendment






2.   The risk 
assessment
 shall include general and targeted recommendations for response as a basis for coordination in the HSC.




2.   The risk 
assessments referred to in paragraph 1
 shall include
, where possible,
 general and targeted recommendations for response as a basis for coordination in the HSC
, including, but not limited to:







 










(a)






a forecast of the evolution of a health crisis and the risk of a health emergency;










 










(b)






a forecast of the demand for medicines, vaccines, medical equipment, protective equipment and hospital capacity, including within the Union Civil Protection Mechanism;










 










(c)






identification of vulnerable groups in society, such as patients suffering from chronic conditions, patients with major non-communicable diseases, the elderly, children, pregnant women and professions with a high risk of infection or transmission, including specific needs for medicines and hospital capacity for those vulnerable groups;










 










(d)






identification of possible protective measures and assessment of their efficacy;










 










(e)






assessment of the possible need for activation of the EU Health Task Force
.









Amendment 113


Proposal for a regulation


Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004
Article 8a — paragraph 3







Text proposed by the Commission




Amendment






3.   For the purposes of paragraph 1, the Centre shall coordinate the preparation of rapid risk assessments by involving Member States experts and relevant agencies
, if necessary
.




3.   For the purposes of paragraph 1, the Centre shall coordinate the preparation of rapid risk assessments by involving Member States experts and relevant agencies 
and organisations
.






Amendment 114


Proposal for a regulation


Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004
Article 8a — paragraph 4 a (new)







Text proposed by the Commission




Amendment





 





4a.
   
The Centre shall work together with the Member States to improve their risk assessment capacity.








Amendment 115


Proposal for a regulation


Article 1 — paragraph 1 — point 11

Regulation (EC) No 851/2004
Article 8b — paragraph 1 — point a







Text proposed by the Commission




Amendment











(a)


national responses to the serious cross-border threat to health;












(a)


national 
or interregional
 responses to the serious cross-border threat to health;









Amendment 116


Proposal for a regulation


Article 1 — paragraph 1 — point 11

Regulation (EC) No 851/2004
Article 8b — paragraph 1 — point b







Text proposed by the Commission




Amendment











(b)


adoption of 
guidance
 for the Member States for the prevention and control of a serious cross-border threat to health.












(b)


adoption of 
common guidelines
 for the Member States for the prevention
, treatment
 and control of a serious cross-border threat to health;









Amendment 117


Proposal for a regulation


Article 1 — paragraph 1 — point 11

Regulation (EC) No 851/2004
Article 8b — paragraph 1 — point b a (new)







Text proposed by the Commission




Amendment





 










(ba)






the deployment of the EU Health Task Force.











Amendment 118


Proposal for a regulation


Article 1 — paragraph 1 — point 11

Regulation (EC) No 851/2004
Article 8b — paragraph 2







Text proposed by the Commission




Amendment






2.   The Centre shall support a Union coordinated response 
at the request of a Member State, Council, Commission, Union bodies or agencies
.




2.   The Centre shall support a Union coordinated response 
in accordance with Article 21 of Regulation (EU) …/… [the SCBTH Regulation]
.






Amendment 119


Proposal for a regulation


Article 1 — paragraph 1 — point 12 — point a

Regulation (EC) No 851/2004
Article 9 — paragraph 2







Text proposed by the Commission




Amendment






2.   The Centre may be requested by the Commission, the Member States, third countries, in particular EU partner countries, and international organisations (in particular the WHO) to provide scientific or technical assistance in any field within the scope of its mission. The assistance may include aiding the Commission and Member States to develop technical guidelines on good practice and on protective measures to be taken in response to human health threats, providing expert assistance, mobilising and coordinating investigation teams. The Centre shall provide scientific and technical expertise and assistance within its financial capacity and mandate, and in accordance with the appropriate working arrangements established with the Commission.




2.   The Centre may be requested by the Commission, the Member States, third countries, in particular EU partner countries, and international organisations (in particular the WHO) to provide scientific or technical assistance in any field within the scope of its mission. The assistance may include aiding the Commission and Member States to develop technical guidelines on good practice and on protective measures to be taken in response to human health threats, providing expert assistance, mobilising and coordinating investigation teams 
and assessing the efficiency of response measures
. The Centre shall provide scientific and technical expertise and assistance within its financial capacity and mandate, and in accordance with the appropriate working arrangements established with the Commission.






Amendment 120


Proposal for a regulation


Article 1 — paragraph 1 — point 12 — point c

Regulation (EC) No 851/2004
Article 9 — paragraph 6







Text proposed by the Commission




Amendment






6.   The Centre shall, as appropriate, support and coordinate training programmes, in particular in epidemiological surveillance, field investigations, preparedness and prevention, 
and
 public health research.




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,
 public health research 
and risk communication
. 
Those programmes shall take into consideration the need for training to be kept up-to-date and shall respect the principle of proportionality and the training needs of Member States.








Amendment 121


Proposal for a regulation


Article 1 — paragraph 1 — point 13 — point a

Regulation (EC) No 851/2004
Article 11 — paragraph 1







Text proposed by the Commission




Amendment






1.   The Centre shall coordinate data collection, validation, analysis and dissemination of data at Union level.




1.   The Centre shall coordinate data
, standardisation,
 collection, validation, analysis and dissemination of data at Union level.






Amendment 122


Proposal for a regulation


Article 1 — paragraph 1 — point 13 — point b

Regulation (EC) No 851/2004
Article 11 — paragraph 1a — point a







Text proposed by the Commission




Amendment











(a)


epidemiological surveillance of communicable diseases and 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]];












(a)


epidemiological surveillance of communicable diseases
, other health threats, such as major non-communicable diseases,
 and related special health issues referred to in 
point
 (ii) of point (a) of Article 2(1) of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]];









Amendment 123


Proposal for a regulation


Article 1 — paragraph 1 — point 13 — point b

Regulation (EC) No 851/2004
Article 11 — paragraph 1a — point b







Text proposed by the Commission




Amendment











(b)


the progression of epidemic situations, including for modelling, anticipation and scenario development;












(b)


the progression of epidemic situations, including for modelling, anticipation and scenario development
, the assessment of vulnerable groups and the forecast of specific demand for medicines, equipment and hospital capacity
;









Amendment 124


Proposal for a regulation


Article 1 — paragraph 1 — point 13 — point b

Regulation (EC) No 851/2004
Article 11 — paragraph 1a — point e a (new)







Text proposed by the Commission




Amendment





 










(ea)






implementation of the Centre’s recommendations on countermeasures by Member States and the outcomes thereof.











Amendment 125


Proposal for a regulation


Article 1 — paragraph 1 — point 13 — point c

Regulation (EC) No 851/2004
Article 11 — paragraph 2 — point c







Text proposed by the Commission




Amendment











(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; and












(c)


work in close cooperation with the competent bodies of the organisations 
and relevant counterparts
 operating in the field of data collection from the Union, third countries, the WHO, other international organisations 
and the scientific community, while ensuring that robust safeguards are in place concerning transparency and accountability
; and









Amendment 126


Proposal for a regulation


Article 1 — paragraph 1 — point 13 — point c

Regulation (EC) No 851/2004
Article 11 — paragraph 2 — point d







Text proposed by the Commission




Amendment











(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.












(d)


develop solutions to access relevant health data
, including anonymous data and pseudonymous data, where such data are
 made available or exchanged through digital infrastructures, in accordance with data protection rules, allowing for the health data to be 
solely
 used for healthcare, 
health
 research, policy making and regulatory purposes 
in the domain of health
; and provide and facilitate controlled access to health data to support public health research.









Amendment 127


Proposal for a regulation


Article 1 — paragraph 1 — point 13 — point d

Regulation (EC) No 851/2004
Article 11 — paragraph 4







Text proposed by the Commission




Amendment






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 
European Medicines Agency
, in an objective, reliable and easily accessible way and on the basis of the best available information.




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 
a Member State,
 the 
Commission or EMA
, in an objective, reliable and easily accessible way and on the basis of the best available information.






Amendment 128


Proposal for a regulation


Article 1 — paragraph 1 — point 14

Regulation (EC) No 851/2004
Article 11a — paragraph 1







Text proposed by the Commission




Amendment






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, to assist local response to outbreaks of communicable diseases in Member States and in third countries.




1.   The Centre shall establish 
a permanent capacity, as well as an enhanced emergency
 capacity to mobilise and deploy the EU Health Task Force including the Centre's staff, experts from Member States, 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 129


Proposal for a regulation


Article 1 — paragraph 1 — point 14

Regulation (EC) No 851/2004
Article 11a — paragraph 1 a (new)







Text proposed by the Commission




Amendment





 





1a.
   
The Centre shall develop capacities to conduct field research and gather relevant data, such as on the genetic variation of communicable diseases, using the dedicated reference laboratory network or its own resources.








Amendment 130


Proposal for a regulation


Article 1 — paragraph 1 — point 14

Regulation (EC) No 851/2004
Article 11a — paragraph 2







Text proposed by the Commission




Amendment






2.   The Centre shall develop a framework and establish procedures with the Commission to mobilise the EU Health Task Force.




2.   The Centre shall develop a framework and establish procedures with the Commission to 
deploy the permanent capacity and
 mobilise 
the emergency capacity of
 the EU Health Task Force.






Amendment 131


Proposal for a regulation


Article 1 — paragraph 1 — point 14

Regulation (EC) No 851/2004
Article 11a — paragraph 4 — subparagraph 1







Text proposed by the Commission




Amendment





The Centre shall develop with the Commission a framework for the mobilisation of the EU Health Task Force, in view of action under Decision No 1313/2013/EU (*5).


The Centre shall develop with the Commission a framework for 
the deployment of the permanent capacity and
 the mobilisation of the EU Health Task Force, in view of action under Decision No 1313/2013/EU (*6).





Amendment 132


Proposal for a regulation


Article 1 — paragraph 1 — point 14

Regulation (EC) No 851/2004
Article 11a — paragraph 6







Text proposed by the Commission




Amendment






6.   The Centre shall maintain capacity to carry out missions to Member States, upon request of the Commission and Member States, to provide recommendations on response to threats to health within its mandate.




6.   The Centre shall maintain 
a permanent
 capacity to carry out missions to Member States, upon request of the Commission and Member States, to provide recommendations on response to threats to health within its mandate.






Amendment 133


Proposal for a regulation


Article 1 — paragraph 1 — point 15 — point a

Regulation (EC) No 851/2004
Article 12 — paragraph 1 — subparagraph 2







Text proposed by the Commission




Amendment





The Centre shall ensure that the public or any interested party is rapidly given objective, reliable, evidence-based and easily accessible information with regard to the results of its work. The Centre shall make available information for the general public, including through a dedicated website It shall also publish its opinions produced in accordance with Article 6.


The Centre shall ensure that the public or any interested party is rapidly given objective, reliable, evidence-based and easily accessible information with regard to the results of its work. The Centre shall make available information for the general public, including through a dedicated website 
with essential information available in all official languages of the Union.
 It shall also publish its opinions produced in accordance with Article 6 
in a timely manner
.





Amendment 134


Proposal for a regulation


Article 1 — paragraph 1 — point 15 — point b

Regulation (EC) No 851/2004
Article 12 — paragraph 2







Text proposed by the Commission




Amendment













(b)






paragraph 2 is deleted;










deleted







Amendment 135


Proposal for a regulation


Article 1 — paragraph 1 — point 15 — point c

Regulation (EC) No 851/2004
Article 12 — paragraph 3







Text proposed by the Commission




Amendment






3.   The Centre shall cooperate as appropriate with the competent bodies in the Member States and other interested parties with regard to public information campaigns.




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 136


Proposal for a regulation


Article 1 — paragraph 1 — point 16 — point a

Regulation (EC) No 851/2004
Article 14 — paragraph 2 — subparagraph 3







Text proposed by the Commission




Amendment





Members’ term of office shall be three years and can be extended.


Members’ term of office shall be three years and can be extended
, if necessary
.





Amendment 137


Proposal for a regulation


Article 1 — paragraph 1 — point 16 — point b

Regulation (EC) No 851/2004
Article 14 — paragraph 5 — subparagraph 1 — point e







Text proposed by the Commission




Amendment











(e)


adopt a draft single programming document in line with Article 32 of the Commission Delegated Regulation (EU) 2019/715 (*) and the related Commission’s guidelines for the Single Programming Document**;












(e)




by 30 November of each year,
 adopt a draft single programming document in line with Article 32 of the Commission Delegated Regulation (EU) 2019/715 (*) and the related Commission’s guidelines for the Single Programming Document; 
the single programming document shall be adopted where a positive opinion has been given by the Commission and, as regards multiannual programming, after consulting the European Parliament and the Council;











Amendment 138


Proposal for a regulation


Article 1 — paragraph 1 — point 16 — point b

Regulation (EC) No 851/2004
Article 14 — paragraph 5 — subparagraph 1 — point i







Text proposed by the Commission




Amendment











(i)


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
.












(i)


determine 
by unanimity
 the rules governing the languages of the Centre, including the possibility of a distinction between the 
ordinary
 internal workings of the Centre and 
its
 external communication, taking into account the need to ensure access 
for all interested parties
 to the work of the Centre 
in as many official languages of the Union as possible, as well as expert scrutiny of scientific findings and public understanding of the Centre's work and recommendations; those rules may include the use of qualified interpreters (working with sign language, or via oral or tactile interpretation) if needed.











Amendment 139


Proposal for a regulation


Article 1 — paragraph 1 — point 18

Regulation (EC) No 851/2004
Article 17 — paragraph 1







Text proposed by the Commission




Amendment













(18)





Article 17 is replaced by the following:









deleted










‘1.
   
Without prejudice to Article 3(2), the director shall be appointed by the Management Board on the basis of a list of candidates proposed by the Commission after an open competition, following publication in the Official Journal of the European Union and elsewhere of a call for expressions of interest, for a period of five years, which may be extended once for a further period of up to five years.;’






 





Amendment 140


Proposal for a regulation


Article 1 — paragraph 1 — point 18

Regulation (EC) No 851/2004
Article 17 — paragraph 2







Text proposed by the Commission




Amendment





 





2.
   
Before appointment, the candidate nominated by the Management Board shall be invited without delay to make a statement before the European Parliament and to answer questions put by members of that institution.








Amendment 141


Proposal for a regulation


Article 1 — paragraph 1 — point 19 — point c

Regulation (EC) No 851/2004
Article 18 — paragraph 8







Text proposed by the Commission




Amendment






8.   The 
director may invite
 experts 
or
 representatives of professional 
or
 scientific bodies
, or
 non-governmental organisations with recognised experience in disciplines related to the work of the Centre 
to cooperate in specific tasks and
 to take part in 
the relevant
 activities of the Advisory Forum. In addition, the Commission may suggest to the 
director
 experts or representatives of professional or scientific bodies, or non-governmental 
organizations
 to be 
invited
 on an ad-hoc basis.




8.   The 
Centre shall structurally engage with public health
 experts, representatives of professional 
and
 scientific bodies 
and
 non-governmental organisations
, in particular those
 with recognised experience in disciplines related to the work of the Centre
, as well as in other areas, including non-communicable diseases and environmental protection,
 to take part in 
all key
 activities of the 
Centre, dedicated networks and the
 Advisory Forum 
and to cooperate on specific tasks
. In addition, the Commission 
and Member States
 may suggest to the 
Centre
 experts or representatives of professional or scientific bodies, or non-governmental 
organisations
 to be 
consulted
 on an ad-hoc basis.






Amendment 142


Proposal for a regulation


Article 1 — paragraph 1 — point 19 a (new)

Regulation (EC) No 851/2004
Article 19 — paragraph 2







Present text




Amendment





 










(19a)





in Article 19, paragraph 2 is replaced by the following:










2.   The members of the Management Board, the director, the members of the Advisory Forum, as well as external experts participating in scientific panels shall make a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be considered prejudicial to their independence. Those declarations shall be made annually in writing.





‘2.   The members of the Management Board, the director, the members of the Advisory Forum, as well as external experts participating in scientific panels shall make a declaration of commitment and a declaration of interests indicating either the absence of any interests which might be considered prejudicial to their independence or any direct or indirect interests which might be considered prejudicial to their independence. Those declarations shall be made annually in writing 
and be available to the public
.’







Amendment 143


Proposal for a regulation


Article 1 — paragraph 1 — point 20 a (new)

Regulation (EC) No 851/2004
Article 20 — paragraph 4







Present text




Amendment





 










(20a)





in Article 20, paragraph 4 is replaced by the following:










4.   Personal data shall not be processed or communicated except in cases where this is strictly necessary for the fulfilment of the mission of the Centre. In such cases, Regulation (
EC
) 
No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data (8)
 shall apply.





‘4.   Personal data shall not be processed or communicated except in cases where this is strictly necessary for the fulfilment of the mission of the Centre. In such cases, Regulation (
EU
) 
2018/1725
 shall apply.’;







Amendment 144


Proposal for a regulation


Article 1 — paragraph 1 — point 20 b (new)

Regulation (EC) No 851/2004
Article 20 — paragraph 4 a (new)







Text proposed by the Commission




Amendment





 










(20b)





in Article 20, the following paragraph is added:









 





‘4a.
   
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.







 




The Centre shall put in place procedures and data protection safeguards designed to guarantee that its processing operations fully respect the data protection principles of lawfulness, fairness and transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity, confidentiality, and data protection by design and by default.






 




The Centre shall only process personal data, in particular in the case of health data relating to identified or identifiable individuals, when it is proven to be necessary and proportionate to do so. Whenever possible, in line with the principle of data minimisation, the Centre shall make use of anonymised data, achieved through techniques used such as randomisation or generalisation.






 




The Commission shall adopt delegated acts in accordance with Article 20a to supplement this Regulation by setting out the categories of data subjects under the scope of the processing and the categories of the personal data processed, together with a description of the specific measures to safeguard the rights and freedoms of the data subjects involved, in line with relevant data protection legislation, in particular with regard to concrete safeguards to prevent abuse or unlawful access or transfer, and the storage periods.’;







Amendment 145


Proposal for a regulation


Article 1 — paragraph 1 — point 20 c (new)

Regulation (EC) No 851/2004
Article 20 a (new)







Text proposed by the Commission




Amendment





 










(20c)





the following Article is inserted:









 




‘Article 20a






 




Exercise of the delegation






 





1.
   
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.







 





2.
   
The power to adopt delegated acts referred to in Article 20(4a) shall be conferred on the Commission for a period of five years from … [date of entry into force of this amending Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.







 





3.
   
The delegation of power referred to in Article 20(4a) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.







 





4.
   
Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making

 (*)

.







 





5.
   
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.







 





6.
   
A delegated act adopted pursuant to Article 20(4a) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.







 






Amendment 146


Proposal for a regulation


Article 1 — paragraph 1 — point 21

Regulation (EC) No 851/2004
Article 21 — paragraph 6







Text proposed by the Commission




Amendment






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.




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
.






Amendment 147


Proposal for a regulation


Article 1 — paragraph 1 — point 23 — point c

Regulation (EC) No 851/2004
Article 23 — paragraph 8







Text proposed by the Commission




Amendment






8.   The director shall send the Court of Auditors a reply to its observations by 30 September at the latest. The director shall also send this reply to the Management Board and to the Commission.




8.   The director shall send the Court of Auditors a reply to its observations by 30 September at the latest. The director shall also send this reply to the Management Board
, the European Parliament, the Council
 and to the Commission.






Amendment 148


Proposal for a regulation


Article 1 — paragraph 1 — point 23 a (new)

Regulation (EC) No 851/2004
Article 24







Present text




Amendment





 










(23a)





Article 24 is replaced by the following:









Article 24


‘Article 24




Application of the Financial Regulation


Application of the Financial Regulation




Article 
185
 of 
the Financial
 Regulation shall apply to the discharge of the Centre’s budget, its audits and accounting rules.


Article 
70
 of Regulation 
(EU, Euratom) 2018/1046
 shall apply to the discharge of the Centre’s budget, its audits and accounting rules.’





Amendment 149


Proposal for a regulation


Article 1 — paragraph 1 — point 28

Regulation (EC) No 851/2004
Article 31 — paragraph 1 — subparagraph 1 — introductory part







Text proposed by the Commission




Amendment





By [please insert date three years after the date of entry into force] 
2023
, the Commission shall submit a report to the European Parliament, the Council and the Management Board on the Centre’s activities, including an assessment of:


By … [please insert date three years after the date of entry into force 
of this amending Regulation
], the Commission shall submit a report to the European Parliament, the Council and the Management Board on the Centre’s activities, including an assessment of:





Amendment 150


Proposal for a regulation


Article 1 — paragraph 1 — point 28

Regulation (EC) No 851/2004
Article 31 — paragraph 1 — subparagraph 1 — point a a (new)







Text proposed by the Commission




Amendment





 










(aa)






how the Centre has implemented the governance structures referred to in Articles 14, 17 and 18;











Amendment 151


Proposal for a regulation


Article 1 — paragraph 1 — point 28

Regulation (EC) No 851/2004
Article 31 — paragraph 2







Text proposed by the Commission




Amendment






2.   By [please insert date 
three
 years after the date of entry into force] 
2028
, and every 5 years thereafter, the Commission shall assess the Centre’s performance in relation to its objectives, mandate, tasks, procedure and location. The evaluation shall, in particular, address the possible need to modify the mandate of the Centre, and the financial implications of any such modification.




2.   By … [please insert date 
five
 years after the date of entry into force 
of this amending Regulation
], and every 5 years thereafter, the Commission shall assess the Centre’s performance in relation to its objectives, mandate, tasks, procedure and location. The evaluation shall, in particular, address the possible need to modify the mandate of the Centre, and the financial implications of any such modification.






Amendment 152


Proposal for a regulation


Article 1 — paragraph 1 — point 28

Regulation (EC) No 851/2004
Article 31 — paragraph 3







Text proposed by the Commission




Amendment






3.   Where the Commission considers that the continued operation of the Centre is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed.




3.   
Based on the assessment referred to in paragraph 2, the Commission shall, where appropriate, submit a legislative proposal to amend this Regulation.
 Where the Commission considers that the continued operation of the Centre is no longer justified with regard to its assigned objectives, mandate and tasks, it may propose that the relevant provisions of this Regulation be amended accordingly or repealed.







(1)  The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A9-0253/2021).

(1a)  
Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1).



(10)  Regulation (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).]

(10)  Regulation (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).]

(11)  Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).

(12)  Regulation (EU) No 233/2014 of the European Parliament and of the Council of 11 March 2014 establishing a financing instrument for development cooperation for the period 2014-2020 (OJ L 77, 15.3.2014, p. 44).

(11)  Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).

(12)  Regulation (EU) No 233/2014 of the European Parliament and of the Council of 11 March 2014 establishing a financing instrument for development cooperation for the period 2014-2020 (OJ L 77, 15.3.2014, p. 44).

(1a)  
Regulation (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).



(1a)  
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).



(1b)  
Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).



(1a)  

OJ L 123, 12.5.2016, p. 1.



(*1)  
Regulation (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).



(*2)  
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).



(*3)  
Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).



(*4)  
Regulation (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).



(*5)  Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).

(*6)  Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).

(*)  Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (OJ L 122, 10.5.2019, p. 1).

(*)  Commission Delegated Regulation (EU) 2019/715 of 18 December 2018 on the framework financial regulation for the bodies set up under the TFEU and Euratom Treaty and referred to in Article 70 of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (OJ L 122, 10.5.2019, p. 1).

(*)  

OJ L 123, 12.5.2016, p. 1.’;