# C_2022117EN.01019201.xml

| 11.3.2022 | EN | Official Journal of the European Union | C 117/192 |
| --- | --- | --- | --- |

11.3.2022

EN

Official Journal of the European Union

C 117/192

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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. |

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. |
| --- | --- |

(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. |

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. |

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
  . |
| --- | --- |

(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. |

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. |

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. |

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. |

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]. |

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]. |
| --- | --- |

(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. |

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. |
| --- | --- |

(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
  . |

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
  . |
| --- | --- |

(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. |

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, |

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. |
| --- | --- |

(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. |

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. |
| --- | --- |

(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. |

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. |
| --- | --- |

(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. |

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. |
| --- | --- |

(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
  . |

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
  . |
| --- | --- |

(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. |

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. |
| --- | --- |

(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. |

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. |
| --- | --- |

(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. |

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. |
| --- | --- |

(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. |

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. |
| --- | --- |

(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. |

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. |
| --- | --- |

(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. |

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. |

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. |

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. |

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. |

Text proposed by the Commission

Amendment

(17e)

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. |

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. |
| --- | --- |

(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. |

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. |
| --- | --- |

(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. |

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. |

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. |

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. |

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. |
| --- | --- |

(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; |

Text proposed by the Commission

Amendment

(1a)

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; |

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; |
| --- | --- |

(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; |

Text proposed by the Commission

Amendment

(4a)

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. |

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
  . |

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. |

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: |

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

Amendment 40

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point a

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(a)

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

considering

| (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
  ; |
| --- | --- |

(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
  ;

taking into account

available

, including artificial intelligence

Amendment 41

Amendment 41

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point a 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(aa)

(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;

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

Amendment 42

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point a 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ab)

(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;

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

Amendment 43

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point b

| 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
  ; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ;

contribution

, 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; |
| --- | --- |

(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;

, guidelines

including possible severe impacts on patients suffering from major non-communicable diseases, and contributions with regard

Amendment 44

Amendment 44

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point b a (new)

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ba)

(ba)

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

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

Amendment 45

Amendment 45

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point c

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ; |
| --- | --- |

(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
  ;

, organisations and experts

, while ensuring full compliance with the rules on transparency and conflicts of interest

Amendment 46

Amendment 46

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point d

| Text proposed by the Commission | Amendment |
| --- | --- |
| (d) | exchange information, expertise and best practice; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ; |
| --- | --- |

(d)

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

, as well as provide scientific and technical assistance, including training

Amendment 47

Amendment 47

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point e

| Text proposed by the Commission | Amendment |
| --- | --- |
| (e) | monitor health systems’ capacity relevant to the management of communicable disease threats and other special health issues; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ; |
| --- | --- |

(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
  ;

, 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

Amendment 48

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point e 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ea)

(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;

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

Amendment 49

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point e 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(eb)

(eb)

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

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

Amendment 50

Amendment 50

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ; |
| --- | --- |

(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
  ;

in the area of health

Amendment 51

Amendment 51

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point 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
  ; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ;

HSC,

for

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
  ; |
| --- | --- |

(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
  ;

Health Security Committee (‘HSC’) established under Article 4 of Regulation (EU) .../... [the SCBTH Regulation],

on

, recommendations and proposals for coordinated action for surveillance, monitoring, diagnosis,

such as major non-communicable diseases, including

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

Amendment 52

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point h

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ; |
| --- | --- |

(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
  ;

and close coordination

, 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

Amendment 53

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point h a (new)

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ha)

(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;

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

Amendment 54

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point j

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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.

or the Health Security Committee (‘HSC’)

| (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; |
| --- | --- |

(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;

, the HSC

or on its own initiative, timely, easily accessible and

in all official languages of the Union

, on their possible impact on patients suffering from major non-communicable diseases,

Amendment 55

Amendment 55

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point j 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ja)

(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.

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

Amendment 56

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 3

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 57

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — 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
  : |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  :

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

Amendment 58

Amendment 58

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — point a

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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;

in a timely manner and

| (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; |
| --- | --- |

(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;

regularly

timelines,

Amendment 59

Amendment 59

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — point a 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(aa)

(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;

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

Amendment 60

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — point 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 |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

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]]; |
| --- | --- |

(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

Amendment 61

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — point c

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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.

and

| (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. |
| --- | --- |

(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.

and organisations

, to cross-border regions or to third countries

Amendment 62

Amendment 62

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — point c a (new)

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ca)

(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;

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

Amendment 63

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — point c b (new)

| 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 |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(cb)

(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

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

Amendment 64

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — point c c (new)

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(cc)

(cc)

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

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

Amendment 65

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 1

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 66

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 1

| 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]]. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

the related

points (i) and

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]].

, such as an unpredicted rise in major non-communicable diseases or chronic conditions and in health-related environmental hazards, including those

point

Amendment 67

Amendment 67

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 2 — point a

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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;

further

| (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; |
| --- | --- |

(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;

continuous

, including the platform for surveillance established under Article 14 of Regulation (EU) .../... [the SCBTH Regulation],

and proving the necessity and proportionality of data collection and use following a data protection impact assessment (‘DPIA’),

digital

, 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

Amendment 68

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 2 — point b

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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; |
| --- | --- |

(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;

and assessment indicators

Amendment 69

Amendment 69

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 2 — point c

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ; |
| --- | --- |

(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
  ;

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

Amendment 70

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 2 — point c a (new)

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ca)

(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;

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

Amendment 71

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 2 — point d

| Text proposed by the Commission | Amendment |
| --- | --- |
| (d) | communicate the results of the analysis of data to the Commission and Member States; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ; |
| --- | --- |

(d)

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

and propose communications to inform the public

Amendment 72

Amendment 72

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 2 — point g

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  . |
| --- | --- |

(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
  .

, 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,

or phenomena with a potential severe health impact at Union or interregional level

Amendment 73

Amendment 73

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 74

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 4 — point a

| 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 |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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; |
| --- | --- |

(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;

and their interconnection with major non-communicable diseases and chronic conditions and implications for patients with such diseases and conditions

Amendment 75

Amendment 75

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 4 — point d

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ; |
| --- | --- |

(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
  ;

and the resilience of the national health systems in the event of major disease outbreaks, based on common indicators and definitions

Amendment 76

Amendment 76

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 4 — point f

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ; |
| --- | --- |

(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
  ;

, and patients’ comorbidities

Amendment 77

Amendment 77

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 4 — point h

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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.

and

| (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. |
| --- | --- |

(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.

and climatic

Amendment 78

Amendment 78

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 5 — subparagraph 1

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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.

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

Amendment 79

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 5 — subparagraph 3

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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.

as well as proposals for the prevention and control of communicable diseases

Amendment 80

Amendment 80

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 6

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 81

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 6 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 82

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 8 — subparagraph 1

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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.

and coordination

the microbiological safety of substances of human origin encompassing

established under Article 16 of Regulation (EU) .../... [the SCBTH Regulation]

Amendment 83

Amendment 83

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 8 — subparagraph 2

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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.

disease

and their supply

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.

of communicable diseases

the safety and sufficiency of the supply of

Amendment 84

Amendment 84

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 5

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
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 85

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 5

Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004

Article 5a — paragraph 2

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 86

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 5

Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004

Article 5a — paragraph 2 — 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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.

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

Amendment 87

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 5

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 88

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 5

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 89

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

Article 5b — paragraph 1 — subparagraph 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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.

and

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.

recommendations and

and representatives of civil society

Amendment 90

Amendment 90

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

Article 5b — paragraph 1 — subparagraph 2 — point c

| 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]]; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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]];

facilitate self-assessments and external evaluation of

| (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; |
| --- | --- |

(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;

assess

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

Amendment 91

Amendment 91

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

Article 5b — paragraph 1 — subparagraph 2 — point 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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; |
| --- | --- |

(e)

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

, stress tests

Amendment 92

Amendment 92

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

Article 5b — paragraph 1 — subparagraph 2 — point 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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; |
| --- | --- |

(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;

, amongst other things,

Amendment 93

Amendment 93

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

Article 5b — paragraph 1 — subparagraph 2 — point h

| Text proposed by the Commission | Amendment |
| --- | --- |
| (h) | develop targeted activities addressing at-risk groups and community preparedness; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ; |
| --- | --- |

(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
  ;

, in particular taking into account the risks associated with the causes and treatment of major non-communicable diseases

Amendment 94

Amendment 94

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

Article 5b — paragraph 1 — subparagraph 2 — point i

| 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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; |
| --- | --- |

(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;

based on common indicators

and related health risks

in particular as regards minimum testing capacities,

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

Amendment 95

Amendment 95

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 7 — point a

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 96

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 7 — point b

Article 1 — paragraph 1 — point 7 — point b

Regulation (EC) No 851/2004

Article 6 — paragraph 3 — subparagraph 1

| 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
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  .

and

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
  .

and WHO

by encouraging consultation of, and cooperation with, public health experts

Amendment 97

Amendment 97

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 7 — point b

Article 1 — paragraph 1 — point 7 — point b

Regulation (EC) No 851/2004

Article 6 — paragraph 3 — subparagraph 2

| 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
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  .

solely

health

in the domain of health

, after it has proven the necessity and proportionality of using those data

Amendment 98

Amendment 98

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 7 — point b

Article 1 — paragraph 1 — point 7 — point b

Regulation (EC) No 851/2004

Article 6 — paragraph 3 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 99

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 7 — point c

Article 1 — paragraph 1 — point 7 — point c

Regulation (EC) No 851/2004

Article 6 — paragraph 4

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 100

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 8

Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004

Article 7 — paragraph 1 — point c

| Text proposed by the Commission | Amendment |
| --- | --- |
| (c) | at the request of the Commission;
  and |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(c)

at the request of the Commission;
  and

and

| (c) | at the request of the Commission
  or EMA
  ; |
| --- | --- |

(c)

at the request of the Commission
  or EMA
  ;

or EMA

Amendment 101

Amendment 101

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 8

Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004

Article 7 — paragraph 1 — point c a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ca) | at the request of the HSC; and |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ca)

(ca)

at the request of the HSC; and

at the request of the HSC; and

Amendment 102

Amendment 102

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 8

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 103

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 8

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 104

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 8

Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004

Article 7 — paragraph 5

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 105

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 9

Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004

Article 8 — paragraph 1

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 106

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 9

Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004

Article 8 — paragraph 2 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | provide information, expertise, advice and risk assessment to Member States and the Commission; and |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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 |
| --- | --- |

(b)

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

, training

Amendment 107

Amendment 107

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 9

Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004

Article 8 — paragraph 2 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 108

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 9

Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004

Article 8 — paragraph 3

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 109

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 9

Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004

Article 8 — paragraph 5

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 110

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 10

Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004

Article 8a — paragraph 1

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 111

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 10

Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004

Article 8a — paragraph 1 a (new)

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 112

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 10

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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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)

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

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; |
| --- | --- |

(b)

(b)

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

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; |
| --- | --- |

(c)

(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;

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; |
| --- | --- |

(d)

(d)

identification of possible protective measures and assessment of their efficacy;

identification of possible protective measures and assessment of their efficacy;

| (e) | assessment of the possible need for activation of the EU Health Task Force
  . |
| --- | --- |

(e)

(e)

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

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

Amendment 113

Amendment 113

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 10

Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004

Article 8a — paragraph 3

| 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
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 114

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 10

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

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

Amendment 115

Amendment 115

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 11

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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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; |
| --- | --- |

(a)

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

or interregional

Amendment 116

Amendment 116

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 11

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

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

guidance

| (b) | adoption of
  common guidelines
  for the Member States for the prevention
  , treatment
  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;

common guidelines

, treatment

Amendment 117

Amendment 117

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 11

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ba)

(ba)

the deployment of the EU Health Task Force.

the deployment of the EU Health Task Force.

Amendment 118

Amendment 118

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 11

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]
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 119

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 12 — point a

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 120

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 12 — point c

Article 1 — paragraph 1 — point 12 — point c

Regulation (EC) No 851/2004

Article 9 — paragraph 6

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 121

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 13 — point a

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 122

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 13 — point b

Article 1 — paragraph 1 — point 13 — point b

Regulation (EC) No 851/2004

Article 11 — paragraph 1a — 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]]; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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]];

points (i) and

| (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]]; |
| --- | --- |

(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]];

, other health threats, such as major non-communicable diseases,

point

Amendment 123

Amendment 123

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 13 — point b

Article 1 — paragraph 1 — point 13 — point b

Regulation (EC) No 851/2004

Article 11 — paragraph 1a — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | the progression of epidemic situations, including for modelling, anticipation and scenario development; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  ; |
| --- | --- |

(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
  ;

, the assessment of vulnerable groups and the forecast of specific demand for medicines, equipment and hospital capacity

Amendment 124

Amendment 124

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 13 — point b

Article 1 — paragraph 1 — point 13 — point b

Regulation (EC) No 851/2004

Article 11 — paragraph 1a — 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ea)

(ea)

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

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

Amendment 125

Amendment 125

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 13 — point c

Article 1 — paragraph 1 — point 13 — point c

Regulation (EC) No 851/2004

Article 11 — paragraph 2 — point c

| 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 |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

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 |
| --- | --- |

(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

and relevant counterparts

and the scientific community, while ensuring that robust safeguards are in place concerning transparency and accountability

Amendment 126

Amendment 126

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 13 — point c

Article 1 — paragraph 1 — point 13 — point c

Regulation (EC) No 851/2004

Article 11 — paragraph 2 — point d

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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. |
| --- | --- |

(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.

, including anonymous data and pseudonymous data, where such data are

solely

health

in the domain of health

Amendment 127

Amendment 127

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 13 — point d

Article 1 — paragraph 1 — point 13 — point d

Regulation (EC) No 851/2004

Article 11 — paragraph 4

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 128

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 14

Article 1 — paragraph 1 — point 14

Regulation (EC) No 851/2004

Article 11a — paragraph 1

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 129

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 14

Article 1 — paragraph 1 — point 14

Regulation (EC) No 851/2004

Article 11a — paragraph 1 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 130

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 14

Article 1 — paragraph 1 — point 14

Regulation (EC) No 851/2004

Article 11a — paragraph 2

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 131

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 14

Article 1 — paragraph 1 — point 14

Regulation (EC) No 851/2004

Article 11a — paragraph 4 — subparagraph 1

| 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). |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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).

*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).

the deployment of the permanent capacity and

*6

Amendment 132

Amendment 132

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 14

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 133

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 15 — point a

Article 1 — paragraph 1 — point 15 — point a

Regulation (EC) No 851/2004

Article 12 — paragraph 1 — subparagraph 2

| 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
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  .

with essential information available in all official languages of the Union.

in a timely manner

Amendment 134

Amendment 134

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 15 — point b

Article 1 — paragraph 1 — point 15 — point b

Regulation (EC) No 851/2004

Article 12 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | paragraph 2 is deleted; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

(b)

paragraph 2 is deleted;

paragraph 2 is deleted;

deleted

deleted

Amendment 135

Amendment 135

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 15 — point c

Article 1 — paragraph 1 — point 15 — point c

Regulation (EC) No 851/2004

Article 12 — paragraph 3

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 136

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 16 — point a

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
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  .

, if necessary

Amendment 137

Amendment 137

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 16 — point b

Article 1 — paragraph 1 — point 16 — point b

Regulation (EC) No 851/2004

Article 14 — paragraph 5 — 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**; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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; |
| --- | --- |

(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;

by 30 November of each year,

*

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

Amendment 138

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 16 — point b

Article 1 — paragraph 1 — point 16 — point b

Regulation (EC) No 851/2004

Article 14 — paragraph 5 — 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
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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
  .

the

, and participation in,

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. |
| --- | --- |

(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.

by unanimity

ordinary

its

for all interested parties

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

Amendment 139

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 18

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: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(18)

(18)

Article 17 is replaced by the following:

deleted

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

Amendment 140

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 18

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 141

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 19 — point c

Article 1 — paragraph 1 — point 19 — point c

Regulation (EC) No 851/2004

Article 18 — paragraph 8

| 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 142

Proposal for a regulation

Proposal for a regulation

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

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: |

Present text

Present text

Amendment

Amendment

(19a)

(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

Amendment 143

Proposal for a regulation

Proposal for a regulation

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

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: |

Present text

Present text

Amendment

Amendment

(20a)

(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

Amendment 144

Proposal for a regulation

Proposal for a regulation

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

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: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(20b)

(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 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 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.’;

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

Amendment 145

Proposal for a regulation

Proposal for a regulation

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

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: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(20c)

(20c)

the following Article is inserted:

‘Article 20a

‘Article 20a

Exercise of the delegation

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

Amendment 146

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 21

Article 1 — paragraph 1 — point 21

Regulation (EC) No 851/2004

Article 21 — paragraph 6

| 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
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 147

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 23 — point c

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 148

Proposal for a regulation

Proposal for a regulation

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

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: |

Present text

Present text

Amendment

Amendment

(23a)

(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.

185

the Financial

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

70

(EU, Euratom) 2018/1046

Amendment 149

Amendment 149

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 28

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: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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:

2023

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:

of this amending Regulation

Amendment 150

Amendment 150

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 28

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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(aa)

(aa)

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

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

Amendment 151

Amendment 151

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 28

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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

Amendment 152

Proposal for a regulation

Proposal for a regulation

Article 1 — paragraph 1 — point 28

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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

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).

1

(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).

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

(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

(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).

11

(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).

12

(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).

11

(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).

12

(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) 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).

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).

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.

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).

*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).

*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).

*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).

*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).

*5

(*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).

*6

(*)  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.’;

*

OJ L 123, 12.5.2016, p. 1.’;

---