P9_TA(2021)0376

European Centre for Disease Prevention and Control ***I

Amendments adopted by the European Parliament on 14 September 2021 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 851/2004 establishing a European Centre for disease prevention and control (COM(2020)0726 — C9-0366/2020 — 2020/0320(COD)) (1)

(Ordinary legislative procedure: first reading)

(2022/C 117/22)

Amendment 1

Proposal for a regulation

Recital 1

Text proposed by the Commission Amendment (1) The Union is committed to protect and improve human health , in particular to combat the major cross-border health scourges , measures concerning monitoring, early warning of and combating serious cross-border threats to health. (1) The Union is committed as a priority to protect and improve human health through the prevention of disease and by tackling major health scourges by means of monitoring, assessing, communicating on, improving preparedness for, providing early warning of, and combating serious cross-border threats to health.

Amendment 2

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission Amendment (2a) In order to have high-performing health systems accessible for all, there is a need for a holistic approach to public health. The Centre should be tasked with the identification and monitoring of the relationship between major non-communicable diseases, with a view to assessing the impact that infectious diseases have on health systems at large and the effect of comorbidities on health outcomes as observed during the COVID-19 pandemic. Based on the Centre's vast experience with Union-level surveillance and monitoring of communicable diseases, its existing tool for data collection (TESSy) and its links to national public health bodies responsible for both communicable and non-communicable diseases, the Centre is in a unique position to deliver comprehensive information on public health that can be used for policy decision-making.

Amendment 3

Proposal for a regulation

Recital 3

Text proposed by the Commission Amendment (3) On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus COVID-19 outbreak a global pandemic. From the challenges experienced in responding to the pandemic it became clear that the Centre’s role in the Union’s framework for health crisis preparedness and response should be strengthened. (3) On 11 March 2020, the World Health Organization (WHO) declared the novel coronavirus COVID-19 outbreak a global pandemic. Given the challenges experienced in responding to the pandemic , in particular for people suffering from non-communicable diseases, and in view of the effectiveness gaps which have been identified in the Union’s reaction in that regard, it became clear that the Union’s framework for health crisis preparedness and response should be strengthened and extended to better use the potential of the Union's and Member States' capacities to respond to future pandemics .

Amendment 4

Proposal for a regulation

Recital 3 a (new)

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

Amendment 5

Proposal for a regulation

Recital 3 b (new)

Text proposed by the Commission Amendment (3b) The capacity of the Centre to implement new tasks will depend on the level of financial assistance available from the Union, as well as on the internal and external human resources available. In order to be able to fulfil the new tasks entrusted to it as a result of the COVID-19 pandemic, the Centre will need increased funding and more employees. Such new resources cannot come to the Centre only from ad hoc project-oriented funds, such as those allocated in accordance with Regulation (EU) 2021/522 of the European Parliament and of the Council (1a) (the ‘EU4Health Programme’), and the resources already allocated to the Centre in the 2021-2027 multiannual financial framework period are not sufficient. It is therefore important that the Centre’s funding and staffing be increased at the earliest opportunity.

Amendment 6

Proposal for a regulation

Recital 3 c (new)

Text proposed by the Commission Amendment (3c) Improving overall population health through disease prevention will help to reduce susceptibility to future infectious outbreaks. Synergies should be fostered with other Union health initiatives, for instance Europe’s Beating Cancer Plan, or Union instruments, such as the EU4Health Programme.

Amendment 7

Proposal for a regulation

Recital 3 d (new)

Text proposed by the Commission Amendment (3d) The over-exploitation of wildlife and other natural resources and the accelerated loss of biodiversity pose a risk to human health. As the health of humans, animals and the environment are inextricably linked, it is crucial to take the ‘One Health’ approach to addressing current and emerging crises.

Amendment 8

Proposal for a regulation

Recital 5

Text proposed by the Commission Amendment (5) This Regulation accordingly expands the mission and tasks of the Centre to enhance the Centre’s capacity to provide the required scientific expertise and to support actions which are relevant to the prevention, preparedness, response planning and combating serious cross-border threats to health in the Union in accordance with Regulation EU …/… of the European Parliament and of the Council (10) [ISC/2020/12524]. (5) This Regulation accordingly expands the mission and tasks of the Centre to enhance the Centre’s capacity to provide the required robust and independent scientific expertise and to support actions which are relevant to the prevention, preparedness, response planning and combating serious cross-border threats to health in the Union , including in relation to the impact of communicable diseases on major non-communicable diseases and especially the interconnections between them, in accordance with Regulation EU …/… of the European Parliament and of the Council (10) [ISC/2020/12524].

Amendment 9

Proposal for a regulation

Recital 6

Text proposed by the Commission Amendment (6) In this respect, the Centre should be tasked with providing epidemiological information and its analysis, epidemiological modelling, anticipation and forecasting, relevant risk assessments and recommendations, which set out options for prevention and control of communicable diseases. Its actions should be consistent with a One-Health approach, recognising the interconnections between human and animal health and the environment. It should monitor the capacity of the national health systems to respond to communicable disease threats, in particular given the importance of this information in the preparation of the national preparedness and response plans. The Centre should support the implementation of actions funded by the relevant Union funding programmes and instruments and related to communicable diseases, provide guidelines for treatment and case management based on a thorough assessment of the latest evidence, support epidemic and outbreak responses in Member States and third countries, including field response, and provide timely objective, reliable and easily accessible information on communicable diseases to the public. The Centre should also establish clear procedures for cooperation with the public health actors in third countries, as well as international organisations competent in the field of public health hence contributing to EU’s commitment to reinforcing partners’ preparedness and response capacity. (6) In this respect, the Centre should be tasked with providing timely epidemiological information and its analysis, epidemiological modelling, anticipation and forecasting, relevant risk assessments and recommendations, which set out options for prevention and control of communicable diseases. Its actions should be consistent with a One-Health approach, recognising the interconnections between human and animal health and the environment , as many outbreaks are of zoonotic origin . It should monitor , assess and support the capacity of the national health systems to respond to communicable disease threats, in particular given the importance of this information in the preparation of the national preparedness and response plans , with a view to enabling Member States to improve their health systems' capacities. Such plans should include recommendations for policy interventions related to mitigation of the impact of communicable diseases on health services and care, in particular with regard to the situation of patients suffering from major non-communicable diseases. The monitoring of Member State health systems’ capacity should be based on common indicators and definitions in order to ensure comparability. The Centre should have a right to organise regular visits to the Member States to assess health systems' capacity to manage health crises and ad hoc inspections to the Member States to verify preparedness and response plans . The Centre should support the implementation of actions funded by the relevant Union funding programmes and instruments and related to communicable diseases, provide guidelines for treatment and case management based on a thorough assessment of the latest evidence, support epidemic and outbreak responses in Member States and third countries, including field response and personnel training , and provide timely objective, reliable and easily accessible information on communicable diseases to the public. The Centre should also establish clear procedures for cooperation with the public health actors in third countries, as well as international organisations competent in the field of public health hence contributing to EU’s commitment to reinforcing partners’ preparedness and response capacity.

Amendment 10

Proposal for a regulation

Recital 7

Text proposed by the Commission Amendment (7) To effectively support the work of the Centre and ensure the fulfilment of its mission, Member States should be tasked to communicate to the Centre data on the surveillance of communicable diseases and other special health issues such as antimicrobial resistance and healthcare-associated infections related to communicable diseases, available scientific and technical data and information relevant to the Centre’s mission, to notify the Centre of any serious cross-border threats to health, information on preparedness and response planning and health system capacity , and provide relevant information that may be useful for coordinating the response, as well as identify recognised competent bodies and public health experts available to assist in Union responses to health threats . (7) Having access to timely and complete data is a precondition for the Centre to be able to conduct rapid risk assessments, including epidemiological modelling and forecasting. To effectively support the work of the Centre and ensure the fulfilment of its mission, Member States should communicate , in a timely manner, to the Centre comparable and high quality data on the surveillance of communicable diseases , such as HIV, viral hepatitis B and C and Tuberculosis, and other special health issues such as antimicrobial resistance and healthcare-associated infections and their impact on major non-communicable diseases , including those relating to mental health. Member States should provide available scientific and technical data and information relevant to the Centre’s mission, notify the Centre of any serious cross-border threats to health and provide information on preparedness and response planning and health system capacity . To avoid duplication of efforts and diverging recommendations, timelines, case definitions, indicators, standards, protocols and procedures for communications should be agreed between the Centre and the Member States and a fluid information exchange should take place between the Centre, the WHO and national agencies .

Amendment 11

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission Amendment (7a) Systematic integration of the analysis and assessment of risks associated with environmental, climate and food factors with epidemiological surveillance, taking into consideration the weaknesses of national health systems and the concentration of vulnerable groups in the population, should be fostered by the Commission in collaboration with the Centre, the European Environment Agency, the European Chemicals Agency and the European Food Safety Authority, to work towards a holistic approach to the prevention and early detection of communicable diseases. Existing instruments, such as the European Climate and Health Observatory, and instruments under development, such as the European Health Emergency Preparedness and Response Authority (HERA), should be used for this purpose.

Amendment 12

Proposal for a regulation

Recital 8

Text proposed by the Commission Amendment (8) To enhance preparedness and response planning activities in the Union, the Centre’s operation of dedicated networks and networking activities should be broadened to reflect the scope of Regulation (EU) …/…. [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. To this end, the Centre should coordinate and provide technical and scientific expertise to the Commission and Member States through dedicated networks with competent coordinating bodies, including newly established networks for laboratories and for supporting transfusion, transplantation and medically assisted reproduction, (8) To enhance preparedness and response planning activities in the Union, the Centre’s operation of dedicated networks and networking activities should be broadened to reflect the scope of Regulation (EU) …/…. [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. To this end, the Centre should coordinate and provide technical and scientific expertise to the Commission, Member States and the Health Security Committee (‘HSC’) through dedicated networks with competent coordinating bodies, including by encouraging cooperation within the Union's newly established networks for laboratories and for supporting transfusion, transplantation and medically assisted reproduction.

Amendment 13

Proposal for a regulation

Recital 9

Text proposed by the Commission Amendment (9) With a view to enhance the effectiveness of epidemiological surveillance of communicable diseases and of the related special health issues in the Union, the Centre should be tasked with the further development of digital platforms and applications, supporting epidemiological surveillance at Union level, enabling the use of digital technologies, such as artificial intelligence, in the compilation and analysis of data, and providing Member States with technical and scientific advice to establish integrated epidemiological surveillance systems. Such digital platforms and applications should be developed with integrated EU space generated data with the intention to be integrate them in the future European Health Data Space as governed by the Union legislation. (9) With a view to enhance the effectiveness of epidemiological surveillance and monitoring of testing for and treatment of communicable diseases, their interconnection with major non-communicable diseases and of the related special health issues in the Union, the Centre should be tasked with the further development of secure and interoperable digital platforms and applications, supporting epidemiological surveillance at Union level, enabling the use of digital technologies, such as artificial intelligence and computer modelling and simulation , in the compilation and analysis of data, and providing Member States with technical and scientific advice to establish integrated epidemiological surveillance systems. Such digital platforms and applications should be developed with integrated EU space generated data with the intention to be integrate them in the future European Health Data Space as governed by the Union legislation.

Amendment 14

Proposal for a regulation

Recital 10

Text proposed by the Commission Amendment (10) To strengthen the capacity of the Union and Member States to assess the epidemiological situation and perform accurate risk assessment and response, the Centre should in particular monitor and report on trends in communicable diseases, support and facilitate evidence-based response action, provide recommendations for improvement of communicable disease prevention and control programmes established at the national and Union level, monitor and assess the capacity of national health systems for diagnosis, prevention and treatment of communicable diseases, including in a gender-sensitive way, identify population groups at risk requiring specific measures, analyse the correlation of disease incidence with societal and environmental factors, and identify risk factors for transmission and disease severity of communicable diseases, and identify research needs and priorities. The Centre should work with nominated national focal points for surveillance, forming a network that strategically advises the Centre on such matters and would promote the use of enabling sectors, such as EU space data and services. (10) To strengthen the capacity of the Union and Member States to assess the epidemiological situation and perform accurate risk assessment and response, the Centre should in particular , based on a set of common indicators proposed by the Centre and developed in close collaboration and consultation with Member States, identify emerging health threats, monitor and report on trends in communicable diseases, support , coordinate and facilitate evidence-based response action, provide recommendations for improvement of communicable disease prevention and control programmes established at the national and Union level, monitor, assess and support Member States with the aim of achieving upward convergence of the capacity of national health systems for diagnosis, prevention, treatment and containment of the spread of communicable diseases, including in a gender-sensitive way, identify population groups at risk requiring specific measures, analyse the correlation of disease incidence with societal, environmental and climate factors, consider the impact of comorbidities on patients with communicable diseases and on their treatment and identify risk factors for transmission and disease severity of communicable diseases, and identify research needs and priorities. The Centre should work with nominated national focal points for surveillance, forming a network that strategically advises the Centre on such matters and would promote the use of enabling sectors, such as EU space data and services.

Amendment 15

Proposal for a regulation

Recital 11

Text proposed by the Commission Amendment (11) The Centre should help strengthen the capacity within the Union to diagnose, detect, identify and characterise infectious agents which may threaten public health by ensuring the operation of the network of Union reference laboratories in accordance with Regulation (EU) …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. This network is responsible for the promotion of good practice and alignment on diagnostics, testing methods, and use of tests, in order to ensure uniform surveillance, notification and reporting of diseases, as well as strengthened quality of testing and surveillance. (11) The Centre should help strengthen the capacity within the Union to diagnose, detect, identify and characterise infectious agents which may threaten public health by ensuring the operation in an integrated manner of a dedicated network of Union reference laboratories in accordance with Regulation (EU) …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. This network is responsible for the promotion of good practice and alignment on diagnostics, testing methods, training in current and innovative procedures and use of tests, in order to ensure uniform surveillance, notification and standardised reporting of diseases, as well as strengthened quality of testing and surveillance.

Amendment 16

Proposal for a regulation

Recital 12

Text proposed by the Commission Amendment (12) Where in case of cross-border health threats posed by communicable diseases, the blood and transplant services in the Member States can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. These services are dependent on rapid risk assessments by the Centre to safeguard patients in need of a therapy from a substance of human origin from the transmission of such a communicable disease. Such risk assessments serve as the basis for appropriate adaptation of measures setting standards for quality and safety of the substances of human origin. The Centre should therefore establish and operate a network of national blood and transplant services and their authorities to serve this purpose . (12) Where in case of cross-border health threats posed by communicable diseases, the blood and transplant services in the Member States can provide a means for rapid testing of the donor population and assessing exposure to and immunity from the disease in the general population. These services are dependent on rapid , comprehensive and accurate risk assessment by the Centre to safeguard patients in need of a therapy from a substance of human origin from the transmission of such a communicable disease. Such risk assessments serve as the basis for appropriate adaptation of measures setting standards for quality and safety of the substances of human origin. The Centre should therefore establish and operate a network of national services and their authorities for the microbiological safety of substances of human origin (SoHO) encompassing transfusion, transplantation and assisted reproduction .

Amendment 17

Proposal for a regulation

Recital 13

Text proposed by the Commission Amendment (13) With the aim of reducing the occurrence of epidemics and strengthening capacities to prevent communicable diseases in the Union, the Centre should develop a framework for the prevention of communicable diseases, which addresses such issues as vaccine preventable diseases, antimicrobial resistance, health education, health literacy and behaviour change. (13) With the aim of reducing the occurrence of epidemics and strengthening capacities to prevent communicable diseases in the Union, the Centre should , working in conjunction with Member States so as to take account of their experiences and respective situations, develop a framework for the prevention of communicable diseases, which addresses such issues as vaccine preventable diseases, vaccine hesitancy, awareness of transmission routes, antimicrobial resistance, health education, health literacy , health inequalities and disease prevention, behaviour change and links with major non-communicable diseases . The Centre should provide guidelines for Member States and monitor the implementation of that framework by Member States.

Amendment 18

Proposal for a regulation

Recital 14

Text proposed by the Commission Amendment (14) The Centre should enhance preparedness and response capabilities at national and Union level by providing scientific and technical expertise to the Member States and the Commission. In this context the Centre, in close collaboration with the Member States and the Commission, should carry out various actions, including the development of Union and national preparedness and response plans and preparedness monitoring and evaluation frameworks, provide recommendations on capacities to prevent, prepare and respond to disease outbreaks and on the strengthening of national health systems. The Centre should broaden its collection and analysis of data in terms of epidemiological surveillance and related special health issues, progression of epidemic situations, unusual epidemic phenomena or new diseases of unknown origin, including in third countries, molecular pathogen data and health systems data. To this end, the Centre should ensure appropriate datasets as well as the procedures to facilitate consultation and data transmission and access, carry out scientific and technical evaluation of prevention and control measures at Union level and work with agencies, competent bodies and organisations operating in the field of data collection. (14) The Centre should enhance preparedness and response capabilities at national and Union level by providing scientific and technical expertise to the Member States and the Commission. In this context the Centre, in close collaboration with the Member States and the Commission, should carry out various actions, including the development of Union preparedness and response plans and contributing to the development of the national preparedness and response plans and preparedness monitoring and evaluation frameworks, provide recommendations on capacities to prevent, prepare and respond to disease outbreaks and on the strengthening of national health systems , including by providing training and by sharing best practices . The Centre should broaden its collection and analysis of data in terms of epidemiological surveillance and related special health issues, progression of epidemic situations, unusual epidemic phenomena or new diseases of unknown origin, including in third countries, molecular pathogen data, health systems data , and data on interconnections between communicable diseases and major non-communicable diseases . To this end, the Centre should ensure appropriate datasets as well as the procedures to facilitate consultation and secure data transmission and access, carry out scientific and technical evaluation of prevention and control measures at Union level and work with the WHO, relevant Union agencies, competent bodies and organisations operating in the field of data collection.

Amendment 19

Proposal for a regulation

Recital 15

Text proposed by the Commission Amendment (15) Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]] provides for the early warning and response system enabling the notification at Union level of alerts related to serious cross-border threats to health which continues to be operated by the ECDC. Given that modern technologies can be of substantial support to combat health threats and to contain and reverse epidemics, the ECDC should work on updating this system to enable the use of artificial intelligence technologies and interoperable and privacy-preserving digital tools, such as mobile applications, with tracing functionalities identifying at-risk individuals. (15) Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]] provides for the early warning and response system enabling the notification at Union level of alerts related to serious cross-border threats to health which continues to be operated by the ECDC. Given that modern technologies can be of substantial support to combat health threats and to contain and reverse epidemics, the ECDC should work on updating this system to enable the use of artificial intelligence , high performance computing, in silico clinical trials and digital twin technologies and interoperable and privacy-preserving digital tools, such as mobile applications, with tracing functionalities identifying at-risk individuals , while mitigating the risks, such as those related to biased datasets, flawed system design, lack of quality data, and overdependence on automated decision-making, and taking into account the importance of establishing safeguards to mitigate those risks during the design and implementation phases of artificial intelligence technologies.

Amendment 20

Proposal for a regulation

Recital 16

Text proposed by the Commission Amendment (16) The Centre should establish appropriate capacities to support international and field response, in accordance with Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. These capacities should enable the Centre to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’, to assist local responses to outbreaks of diseases. The Centre should therefore ensure capacity to carry out missions to Member States as well as in third countries and to provide recommendations on response to health threats. These teams will also be able to be deployed under the Union Civil Protection Mechanism with the support of the Emergency Response Coordination Centre. The Centre should also support the strengthening of preparedness capacities under the International Health Regulations (IHR) in third countries, in order to address serious cross border threats to health and the consequences thereof. (16) The Centre should establish appropriate capacities to support international , interregional and field response, in accordance with Regulation …/… [OJ: please, insert reference to Regulation SCBTH [ISC/2020/12524]]. These capacities should enable the Centre to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’, to assist local responses to outbreaks of diseases and collect field data . The Centre should therefore ensure permanent capacity to carry out missions to Member States as well as in third countries and to provide recommendations on response to health threats. These teams will also be able to be deployed under the Union Civil Protection Mechanism with the support of the Emergency Response Coordination Centre. The Centre should also support the strengthening of preparedness capacities under the International Health Regulations (IHR) in third countries, in order to address serious cross border threats to health and the consequences thereof.

Amendment 21

Proposal for a regulation

Recital 17

Text proposed by the Commission Amendment (17) To assist responses to outbreaks, which may spread within or to the Union, the Centre is to develop a framework for the mobilisation the EU Health Task Force in accordance with Decision No 1313/2013/EU of the European Parliament and of the Council (11) and facilitate the participation of Union field response experts in international response teams in support of the Union Civil Protection Mechanism. The Centre should enhance the capability of its staff as well as experts from Union and EEA countries, candidate countries and potential candidates, as well as European Neighbourhood Policy countries and EU partner countries as referred to in Regulation (EU) No 233/2014 of the European Parliament and of the Council (12), to effectively participate in field missions and crisis management. (17) To assist responses to outbreaks, which may spread within or to the Union, the Centre is to develop a permanent EU Health Task Force and a framework for its mobilisation in accordance with Decision No 1313/2013/EU of the European Parliament and of the Council (11) and facilitate the participation of Union field response experts in international response teams in support of and in close coordination with the Union Civil Protection Mechanism. The Centre should enhance the capability of its staff as well as experts from Union and EEA countries, candidate countries and potential candidates, as well as European Neighbourhood Policy countries and EU partner countries as referred to in Regulation (EU) No 233/2014 of the European Parliament and of the Council (12), to effectively participate in field missions and crisis management. Therefore, the Centre should develop a framework of recognisable expertise levels.

Amendment 22

Proposal for a regulation

Recital 17 a (new)

Text proposed by the Commission Amendment (17a) Member States, the Commission and the Centre should identify recognised competent bodies and public health experts, both in the areas of communicable and non-communicable diseases, available to assist in Union responses to health threats. Such experts and stakeholders, including civil society organisations, should be structurally engaged throughout all activities of the Centre and contribute to its advisory and decision-making processes. Full compliance with transparency and conflict of interest rules for stakeholder engagement should be ensured.

Amendment 23

Proposal for a regulation

Recital 17 b (new)

Text proposed by the Commission Amendment (17b) In order to build a strong European Health Union, the Centre should facilitate the increased cooperation and the exchange of best practices with other Union institutions and agencies, including the future HERA, and ensure coordination of approaches as well as minimise duplication of efforts.

Amendment 24

Proposal for a regulation

Recital 17 c (new)

Text proposed by the Commission Amendment (17c) The Centre should work in close cooperation with the competent bodies and the international organisations in the field of public health in particular the WHO.

Amendment 25

Proposal for a regulation

Recital 17 d (new)

Text proposed by the Commission Amendment (17d) The Centre should communicate in an effective and transparent manner about current and emerging health risks to the general public. The Centre should publish in a timely manner the scientific studies, overviews, surveys, reports, rapid risk assessments and the assessments of the health systems’ capacities in order to increase transparency. The Centre should in this regard address issues regarding transparency as stated in the European Ombudsman’s decision of 5 February 2021 in strategic inquiry OI/3/2020/TE.

Amendment 26

Proposal for a regulation

Recital 17 e (new)

Text proposed by the Commission Amendment (17e) The Centre should ensure gender and geographical balance at staff and management levels as well as ensure a gender sensitive approach in all its operations.

Amendment 27

Proposal for a regulation

Recital 18

Text proposed by the Commission Amendment (18) In order to assess the effectiveness and efficiency of the legal provisions applicable to the Centre, it is appropriate to provide for a regular Commission evaluation of the performance of the Centre. (18) In order to assess the effectiveness and efficiency of the legal provisions applicable to the Centre, it is appropriate to provide for an annual Commission evaluation of the performance of the Centre.

Amendment 28

Proposal for a regulation

Recital 19

Text proposed by the Commission Amendment (19) This Regulation should not confer any regulatory powers on the Centre. (19) This Regulation should not confer any regulatory powers on the Centre. However, the Centre should exercise broad coordination competences and the power to provide recommendations at Union, national and interregional level in the form of clear and uniform science-based proposals.

Amendment 29

Proposal for a regulation

Recital 20 a (new)

Text proposed by the Commission Amendment (20a) Due to the sensitive nature of health data, the Centre should safeguard and guarantee that its processing operations respect the data protection principles of lawfulness, fairness, transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality. With respect to the new tasks conferred on the Centre by this Regulation, the Centre should adopt specific measures for minimising risks that can emerge from the transfer of bias or incomplete data from multiple sources, as well as establish procedures for data quality review. The Centre should strictly respect the principles of data protection as set out in Article 27 of Regulation (EU) 2018/1725 of the European Parliament and of the Council (1a) , while also determining appropriate technical and organisational security measures in accordance with Article 33 of that Regulation.

Amendment 30

Proposal for a regulation

Recital 20 b (new)

Text proposed by the Commission Amendment (20b) The European Data Protection Supervisor should be responsible for monitoring and ensuring the application of the provisions of this Regulation relating to the protection of fundamental rights and freedoms of natural persons with regard to the processing of personal data by the Centre, and for advising the Centre and data subjects on all matters concerning the processing of personal data. Where processing of personal data is not necessary to perform the activities of the Centre, measures should be put in place to ensure use of anonymous data in line with the principle of data minimisation. Where anonymisation would not allow the specific purpose of the processing to be achieved, the data should be pseudonymised. Where it is necessary for the purposes of this Regulation to process personal data, such processing should be done in accordance with Union law on the protection of personal data. Any processing of personal data based on this Regulation should take place in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council (1a) , Regulation (EU) 2018/1725 and Directive 2002/58/EC of the European Parliament and of the Council (1b) . This Regulation should be without prejudice to the obligations of Member States under Regulation (EU) 2016/679 and Directive 2002/58/EC.

Amendment 31

Proposal for a regulation

Recital 20 c (new)

Text proposed by the Commission Amendment (20c) In order to comply with relevant data protection legislation, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of setting out the categories of data subjects within the scope of the processing and the categories of the personal data processed, together with a description of the specific measures to safeguard the rights and freedoms of the data subjects involved. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (1a) . In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

Amendment 32

Proposal for a regulation

Recital 22

Text proposed by the Commission Amendment (22) Since the objectives of this Regulation to expand the mission and tasks of the Centre in order to enhance the Centre’s capacity to provide the required scientific expertise and to support actions which combat serious cross-border threats to health in the Union cannot be sufficiently achieved by the Member States but can rather, by reason of the cross-border nature of the health threats and the need for rapid, coordinated and coherent response, be achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. (22) Since the objectives of this Regulation to expand the mission and tasks of the Centre in order to enhance the Centre’s capacity to provide the required scientific expertise and to support actions which combat serious cross-border threats to health in the Union cannot be sufficiently achieved by the Member States but can rather, by reason of the cross-border nature of the health threats and the need for rapid, better coordinated and coherent response to new emerging health threats , be achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

Amendment 33

Proposal for a regulation

Article 1 — paragraph 1 — point 1

Regulation (EC) No 851/2004

Article 2 — paragraph 1 — point 1 a (new)

Text proposed by the Commission Amendment (1a) ‘prevention and control of human disease’ means the range of recommendations issued by and measures taken by the competent public health authorities in the Member States and the Union, such as the Centre, to prevent and stop the spread of disease;

Amendment 34

Proposal for a regulation

Article 1 — paragraph 1 — point 1

Regulation (EC) No 851/2004

Article 2 — paragraph 1 — point 3

Text proposed by the Commission Amendment (3) ‘dedicated network’ means any specific network on diseases, special health issues or public health functions to ensure collaboration between the coordinating competent bodies of the Member States; (3) ‘dedicated network’ means any specific network on diseases, special health issues or public health functions that is supported and coordinated by the Centre and is intended to ensure collaboration between the coordinating competent bodies of the Member States;

Amendment 35

Proposal for a regulation

Article 1 — paragraph 1 — point 1

Regulation (EC) No 851/2004

Article 2 — paragraph 1 — point 4 a (new)

Text proposed by the Commission Amendment (4a) ‘major non-communicable disease’ means a life-threatening or chronic disease which tends to be of long duration and is the result of a combination of genetic, physiological, environmental and behavioural factors, such as a cardiovascular disease, cancer, respiratory disease, diabetes or mental illness, and which affects a significant number of people in the Union;

Amendment 36

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 1 — subparagraph 1

Text proposed by the Commission Amendment In order to enhance the capacity of the Union and the Member States to protect human health through the prevention and control of communicable diseases in humans and those related special health issues set out in Article 2 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], the mission of the Centre shall be to identify, assess and report on current and emerging threats to human health from communicable diseases, and provide recommendations for response at Union and national levels, as well as at regional level, if necessary . In order to enhance the capacity of the Union and the Member States to protect human health through the prevention and control of communicable diseases in humans and relevant major non-communicable diseases and health issues, including the related special health issues set out in Article 2 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], the mission of the Centre shall be to identify, assess, report and, where appropriate, ensure that information is presented in an easily accessible way on current and emerging threats to human health from communicable diseases and relevant major non-communicable diseases and health issues in collaboration with competent bodies of the Member States or on its own initiative , through the dedicated network, and provide recommendations and support in coordinating the response at Union and national levels, as well as at interregional and regional level, where appropriate . In providing such recommendations, the Centre shall take into account existing national crisis management plans and the respective circumstances of each Member State.

Amendment 37

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 1 — subparagraph 2

Text proposed by the Commission Amendment In the case of other outbreaks of illnesses of unknown origin that may spread within or to the Union, the Centre shall act on its own initiative until the source of the outbreak is known. In the case of an outbreak that clearly is not caused by a communicable disease, the Centre shall act only in cooperation with the competent body upon request from that body . In the case of other outbreaks of illnesses of unknown origin that may spread within or to the Union, the Centre shall act on its own initiative until the source of the outbreak is known. In the case of an outbreak that clearly is not caused by a communicable disease, the Centre shall act in cooperation with the competent bodies upon their request and provide a risk assessment .

Amendment 38

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 1 — subparagraph 3

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

Amendment 39

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — introductory part

Text proposed by the Commission Amendment 2. The Centre shall, within its financial capacity and mandate, perform the following tasks: 2. The Centre shall, within its mandate, perform the following tasks:

Amendment 40

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point a

Text proposed by the Commission Amendment (a) search for, collect, collate, evaluate and disseminate relevant scientific and technical data and information, considering the latest technologies; (a) search for, collect, collate, evaluate and disseminate relevant scientific and technical data and information, taking into account the latest available technologies , including artificial intelligence ;

Amendment 41

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

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

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

Amendment 42

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

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

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

Amendment 43

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point b

Text proposed by the Commission Amendment (b) provide analyses, scientific advice, opinions and support for actions by the Union and Member States on cross-border health threats, including risk assessments, analysis of epidemiological information, epidemiological modelling, anticipation and forecast, recommendations for actions to prevent and control communicable disease threats and other special health issues, contribution to defining research priorities , and scientific and technical assistance including training and other activities within its mandate ; (b) provide analyses, scientific advice, opinions , guidelines and support for actions by the Union and Member States on cross-border health threats, including risk assessments, analysis of epidemiological information, epidemiological modelling, anticipation and forecast, recommendations for actions to prevent and control communicable disease threats and other special health issues, including possible severe impacts on patients suffering from major non-communicable diseases, and contributions with regard to defining research priorities;

Amendment 44

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

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

Text proposed by the Commission Amendment (ba) identify and monitor the impact of major non-communicable diseases on the incidence, severity and mortality rates of communicable diseases;

Amendment 45

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point c

Text proposed by the Commission Amendment (c) coordinate the European networking of bodies operating in the fields within the Centre’s mission, including networks arising from public health activities supported by the Commission and operating the dedicated networks; (c) coordinate the European networking of bodies , organisations and experts operating in the fields within the Centre’s mission, including networks arising from public health activities supported by the Commission and operating the dedicated networks , while ensuring full compliance with the rules on transparency and conflicts of interest ;

Amendment 46

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point d

Text proposed by the Commission Amendment (d) exchange information, expertise and best practice; (d) exchange information, expertise and best practice , as well as provide scientific and technical assistance, including training ;

Amendment 47

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point e

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

Amendment 48

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

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

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

Amendment 49

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

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

Text proposed by the Commission Amendment (eb) support national monitoring of the response to major communicable diseases in order to measure progress in tackling them across the Union;

Amendment 50

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point f

Text proposed by the Commission Amendment (f) facilitate the development and implementation of actions, funded by relevant Union funding programmes and instruments, including the implementation of joint actions; (f) facilitate the development and implementation of actions, funded by relevant Union funding programmes and instruments, including the implementation of joint actions in the area of health ;

Amendment 51

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point g

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

Amendment 52

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point h

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

Amendment 53

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

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

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

Amendment 54

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 2 — point j

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

Amendment 55

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

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

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

Amendment 56

Proposal for a regulation

Article 1 — paragraph 1 — point 2

Regulation (EC) No 851/2004

Article 3 — paragraph 3

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

Amendment 57

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — introductory part

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

Amendment 58

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — point a

Text proposed by the Commission Amendment (a) communicate to the Centre in a timely manner and according to agreed case definitions, indicators, standards, protocols and procedures data on the surveillance of communicable diseases and other special health issues undertaken in accordance with Article 13 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], and available scientific and technical data and information relevant to the Centre’s mission, including on preparedness, and health systems capacities to detect, prevent, respond to and recover from outbreaks of communicable diseases; (a) communicate regularly to the Centre according to agreed timelines, case definitions, indicators, standards, protocols and procedures data on the surveillance of communicable diseases and other special health issues undertaken in accordance with Article 13 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], and available scientific and technical data and information relevant to the Centre’s mission, including on preparedness, and health systems capacities to detect, prevent, respond to and recover from outbreaks of communicable diseases;

Amendment 59

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

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

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

Amendment 60

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — point b

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

Amendment 61

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

Article 4 — paragraph 1 — point c

Text proposed by the Commission Amendment (c) identify, within the scope of the mission of the Centre, recognised competent bodies and public health experts who could be made available to assist in Union responses to health threats, such as by undertaking missions to Member States to provide expert advice and field investigations in the event of disease clusters or outbreaks. (c) identify, within the scope of the mission of the Centre, recognised competent bodies, public health experts and organisations who could be made available to assist in Union responses to health threats, such as by undertaking missions to Member States , to cross-border regions or to third countries to provide expert advice and field investigations in the event of disease clusters or outbreaks.

Amendment 62

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

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

Text proposed by the Commission Amendment (ca) develop national preparedness and response plans in accordance with Article 6 of Regulation (EU) …/… [the SCBTH Regulation], update them in a timely manner taking into account the Centre’s recommendations, and report on their preparedness and response planning and implementation at national level in accordance with Article 7 of that Regulation;

Amendment 63

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

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

Text proposed by the Commission Amendment (cb) facilitate the digitalisation of data collection and the data communication process between the national and the Union surveillance systems while ensuring the financial means to provide timely delivery of the necessary information; and

Amendment 64

Proposal for a regulation

Article 1 — paragraph 1 — point 3

Regulation (EC) No 851/2004

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

Text proposed by the Commission Amendment (cc) immediately notify any delay in the reporting of the data to the Centre with an explanation therefore and a planned date of submission.

Amendment 65

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 1

Text proposed by the Commission Amendment 1. The Centre shall support the networking activities of the competent bodies recognised by the Member States through the provision of coordination and technical and scientific expertise to the Commission and Member States and through the operation of the dedicated networks. 1. The Centre shall support and continuously develop the networking activities of the competent bodies recognised by the Member States through the provision of coordination and technical and scientific expertise to the Commission and Member States and through the operation of the dedicated networks.

Amendment 66

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 1

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

Amendment 67

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 2 — point a

Text proposed by the Commission Amendment (a) ensure the further development of the digital platforms and applications supporting epidemiological surveillance at Union level, supporting Member States with technical and scientific advice to establish integrated surveillance systems enabling real-time surveillance where appropriate, benefiting from existing EU space infrastructures and services; (a) ensure the continuous development of the digital platforms and applications , including the platform for surveillance established under Article 14 of Regulation (EU) …/… [the SCBTH Regulation], supporting epidemiological surveillance at Union level, supporting Member States with technical and scientific advice to establish integrated surveillance systems enabling real-time surveillance where appropriate, and proving the necessity and proportionality of data collection and use following a data protection impact assessment (‘DPIA’), benefiting from existing EU digital space infrastructures and services , with the aim of simplifying the data exchange process and reducing the administrative burden at Union and Member State levels ; those digital platforms and applications shall be implemented with data protection by design and by default pursuant to Article 27 of Regulation (EU) 2018/1725 of the European Parliament and of the Council (*1) , taking into account current state-of-the-art technologies;

Amendment 68

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 2 — point b

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

Amendment 69

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 2 — point c

Text proposed by the Commission Amendment (c) maintain database(s) for such epidemiological surveillance, coordinate with the hosts of other relevant databases, and work towards harmonised approaches to data collection and modelling; (c) maintain database(s) for such epidemiological surveillance, coordinate with the hosts of other relevant databases, and work towards harmonised approaches to data collection and modelling in order to produce comparable Union-wide data as a basis for decision-making ; in carrying out that role, the Centre shall minimise the risks that may emerge from the transfer of inaccurate, incomplete or ambiguous data from one database to another, as well as establish robust procedures for data quality review ;

Amendment 70

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

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

Text proposed by the Commission Amendment (ca) collect and analyse information provided by Member States on the impact of pandemics on the causes and treatment of relevant major non-communicable diseases;

Amendment 71

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 2 — point d

Text proposed by the Commission Amendment (d) communicate the results of the analysis of data to the Commission and Member States; (d) communicate the results of the analysis of data to the Commission and Member States and propose communications to inform the public ;

Amendment 72

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 2 — subparagraph 2 — point g

Text proposed by the Commission Amendment (g) ensure the interoperability of the digital platforms for surveillance with digital infrastructures allowing for the health data to be used for healthcare, research, policy making and regulatory purposes and with a view to integrate those platforms and infrastructures in the European Health Data Space, as regulated by Union legislation, and make use of other relevant data, for example environmental factors. (g) ensure the interoperability of the digital platforms for surveillance with digital infrastructures allowing for the health data to be used for healthcare, research, policy making and regulatory purposes , in compliance with points (h) and (i) of Article 9(2) of Regulation (EU) 2016/679 of the European Parliament and of the Council (*2) , after having conducted a DPIA and having mitigated any risks to the rights and freedoms of the data subjects, and with a view to integrate those platforms and infrastructures in the European Health Data Space, as regulated by Union legislation, and make use of other relevant data, for example environmental factors or phenomena with a potential severe health impact at Union or interregional level .

Amendment 73

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 3

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

Amendment 74

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 4 — point a

Text proposed by the Commission Amendment (a) monitor and report on trends in communicable diseases over time and across Member States and in third countries, based on agreed indicators, to assess the present situation and facilitate appropriate evidence-based action, including through the identification of specifications for harmonised data collection from member states (a) monitor and report on trends in communicable diseases and their interconnection with major non-communicable diseases and chronic conditions and implications for patients with such diseases and conditions over time and across Member States and in third countries, based on agreed indicators, to assess the present situation and facilitate appropriate evidence-based action, including through the identification of specifications for harmonised data collection from member states;

Amendment 75

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 4 — point d

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

Amendment 76

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 4 — point f

Text proposed by the Commission Amendment (f) contribute to the assessment of the burden of communicable diseases on the population using data, such as disease prevalence, complications, hospitalisation and mortality, and ensure that this data is disaggregated on age, gender and disability; (f) contribute to the assessment of the burden of communicable diseases on the population using data, such as disease prevalence, complications, hospitalisation and mortality, and ensure that this data is disaggregated on age, gender and disability , and patients’ comorbidities ;

Amendment 77

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 4 — point h

Text proposed by the Commission Amendment (h) identify risk factors for disease transmission, groups most at risk, including the correlation of disease incidence and severity with societal and environmental factors, and research priorities and needs. (h) identify risk factors for disease transmission, groups most at risk, including the correlation of disease incidence and severity with societal, environmental and climatic factors, and research priorities and needs.

Amendment 78

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 5 — subparagraph 1

Text proposed by the Commission Amendment Each Member State shall designate a coordinating competent body and nominate a national focal point and operational contact points as relevant for public health functions, including epidemiological surveillance, and for various disease groups and individual diseases. Each Member State shall designate a coordinating competent body and nominate a national focal point and operational contact points as relevant for public health functions, including epidemiological surveillance, and for various disease groups and individual diseases. National focal points shall, to the greatest extent possible, be the same as the National IHR Focal Points, in order to minimise the duplication of resources and efforts.

Amendment 79

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 5 — subparagraph 3

Text proposed by the Commission Amendment National focal points and operational contact points nominated for disease-specific interactions with the Centre shall form disease-specific or disease-group-specific networks whose tasks shall include the transmission of national surveillance data to the Centre. National focal points and operational contact points nominated for disease-specific interactions with the Centre shall form disease-specific or disease-group-specific networks whose tasks shall include the transmission of national surveillance data as well as proposals for the prevention and control of communicable diseases to the Centre.

Amendment 80

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 6

Text proposed by the Commission Amendment 6. The Centre shall ensure the operation of the network of EU reference laboratories referred to in Article 15 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], for the diagnosis, detection, identification and characterisation of infectious agents that may present a threat to public health. 6. The Centre shall ensure and coordinate the operation of the network of EU reference laboratories referred to in Article 15 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], for the diagnosis, detection, identification , genetic sequencing and characterisation of infectious agents that may present a threat to public health.

Amendment 81

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 6 a (new)

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

Amendment 82

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 8 — subparagraph 1

Text proposed by the Commission Amendment The Centre shall ensure the operation of the network of Member State services supporting transfusion, transplantation and medically assisted reproduction to allow for continuous and rapid access to sero-epidemiological data via sero-epidemiological surveys within the population, including assessment of donor population exposure and immunity. The Centre shall ensure the operation and coordination of the network of Member State services supporting the microbiological safety of substances of human origin encompassing transfusion, transplantation and medically assisted reproduction established under Article 16 of Regulation (EU) …/… [the SCBTH Regulation] to allow for continuous and rapid access to sero-epidemiological data via sero-epidemiological surveys within the population, including assessment of donor population exposure and immunity.

Amendment 83

Proposal for a regulation

Article 1 — paragraph 1 — point 4

Regulation (EC) No 851/2004

Article 5 — paragraph 8 — subparagraph 2

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

Amendment 84

Proposal for a regulation

Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004

Article 5a — paragraph 1

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

Amendment 85

Proposal for a regulation

Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004

Article 5a — paragraph 2

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

Amendment 86

Proposal for a regulation

Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004

Article 5a — paragraph 2 — subparagraph 1 a (new)

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

Amendment 87

Proposal for a regulation

Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004

Article 5a — paragraph 3

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

Amendment 88

Proposal for a regulation

Article 1 — paragraph 1 — point 5

Regulation (EC) No 851/2004

Article 5a — paragraph 3 a (new)

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

Amendment 89

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

Article 5b — paragraph 1 — subparagraph 1

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

Amendment 90

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

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

Text proposed by the Commission Amendment (c) facilitate self-assessments and external evaluation of Member States’ preparedness and response planning, and contribute to reporting and auditing on preparedness and response planning under Articles 7 and 8 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]]; (c) assess Member States’ preparedness and response planning, and contribute to reporting and auditing on preparedness and response planning under Articles 7 and 8 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]]; the Centre shall send its assessment with recommendations to the Member State and shall make it public;

Amendment 91

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

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

Text proposed by the Commission Amendment (e) develop exercises, in-action and after-action reviews and organise capacity building actions to address identified preparedness capacity and capability gaps; (e) develop exercises , stress tests , in-action and after-action reviews and organise capacity building actions to address identified preparedness capacity and capability gaps;

Amendment 92

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

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

Text proposed by the Commission Amendment (f) develop specific preparedness activities addressing vaccine preventable diseases, antimicrobial resistance, laboratory capacity and biosecurity in accordance with Commission priorities and based upon gaps identified; (f) develop specific preparedness activities addressing , amongst other things, vaccine preventable diseases, antimicrobial resistance, laboratory capacity and biosecurity in accordance with Commission priorities and based upon gaps identified;

Amendment 93

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

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

Text proposed by the Commission Amendment (h) develop targeted activities addressing at-risk groups and community preparedness; (h) develop targeted activities addressing at-risk groups and community preparedness , in particular taking into account the risks associated with the causes and treatment of major non-communicable diseases ;

Amendment 94

Proposal for a regulation

Article 1 — paragraph 1 — point 6

Regulation (EC) No 851/2004

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

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

Amendment 95

Proposal for a regulation

Article 1 — paragraph 1 — point 7 — point a

Regulation (EC) No 851/2004

Article 6 — paragraph 1a

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

Amendment 96

Proposal for a regulation

Article 1 — paragraph 1 — point 7 — point b

Regulation (EC) No 851/2004

Article 6 — paragraph 3 — subparagraph 1

Text proposed by the Commission Amendment The Centre may promote and initiate scientific studies necessary for the performance of its mission and applied scientific studies and projects on the feasibility, development and preparation of its activities. The Centre shall avoid duplication with Commission’s, Member States’ and Union research and health programmes, and will liaise between the public health and the research sector as needed . The Centre may promote and initiate scientific studies necessary for the performance of its mission and applied scientific studies and projects on the feasibility, development and preparation of its activities. The Centre shall avoid duplication with Commission’s, Member States’, Union and WHO research and health programmes, and will liaise between the public health and the research sector by encouraging consultation of, and cooperation with, public health experts .

Amendment 97

Proposal for a regulation

Article 1 — paragraph 1 — point 7 — point b

Regulation (EC) No 851/2004

Article 6 — paragraph 3 — subparagraph 2

Text proposed by the Commission Amendment To carry out the studies referred to in the first paragraph, the Centre shall have access to health data made available or exchanged through digital infrastructures and applications, in accordance with data protection rules, allowing for the health data to be used for healthcare, research, policy making and regulatory purposes. For the purposes of studies under the first paragraph, the Centre shall also make use of other relevant data, for example on environmental and socio-economic factors. To carry out the studies referred to in the first paragraph, the Centre shall have access to health data made available or exchanged through digital infrastructures and applications, in accordance with data protection rules, allowing for the health data to be solely used for healthcare, health research, policy making and regulatory purposes in the domain of health . For the purposes of studies under the first paragraph, the Centre shall also make use of other relevant data, for example on environmental and socio-economic factors , after it has proven the necessity and proportionality of using those data .

Amendment 98

Proposal for a regulation

Article 1 — paragraph 1 — point 7 — point b

Regulation (EC) No 851/2004

Article 6 — paragraph 3 a (new)

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

Amendment 99

Proposal for a regulation

Article 1 — paragraph 1 — point 7 — point c

Regulation (EC) No 851/2004

Article 6 — paragraph 4

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

Amendment 100

Proposal for a regulation

Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004

Article 7 — paragraph 1 — point c

Text proposed by the Commission Amendment (c) at the request of the Commission; and (c) at the request of the Commission or EMA ;

Amendment 101

Proposal for a regulation

Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004

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

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

Amendment 102

Proposal for a regulation

Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004

Article 7 — paragraph 2

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

Amendment 103

Proposal for a regulation

Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004

Article 7 — paragraph 4

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

Amendment 104

Proposal for a regulation

Article 1 — paragraph 1 — point 8

Regulation (EC) No 851/2004

Article 7 — paragraph 5

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

Amendment 105

Proposal for a regulation

Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004

Article 8 — paragraph 1

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

Amendment 106

Proposal for a regulation

Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004

Article 8 — paragraph 2 — point b

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

Amendment 107

Proposal for a regulation

Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004

Article 8 — paragraph 2 a (new)

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

Amendment 108

Proposal for a regulation

Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004

Article 8 — paragraph 3

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

Amendment 109

Proposal for a regulation

Article 1 — paragraph 1 — point 9

Regulation (EC) No 851/2004

Article 8 — paragraph 5

Text proposed by the Commission Amendment 5. The Centre as processor shall have the responsibility to ensure the security and confidentiality of the processing operations of personal data carried out within the EWRS and in the context of interoperability of contact tracing applications, in accordance with the obligations laid down in Articles 33 , 34(2) and 36 of Regulation (EU) 2018/1725 of the European Parliament and of the Council (*4) 5. The Centre shall have the responsibility to ensure the security and confidentiality of the processing operations of personal data carried out within the EWRS and in the context of interoperability of contact tracing applications, in accordance with the obligations laid down in Articles 33 and 36 of Regulation (EU) 2018/1725.

Amendment 110

Proposal for a regulation

Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004

Article 8a — paragraph 1

Text proposed by the Commission Amendment 1. The Centre shall provide timely rapid risk assessments, in accordance with Article 20 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1) of that Regulation including a threat to substances of human origin, such as blood, organs, tissues and cells potentially impacted by communicable diseases, or point (d) of Article 2(1) of that Regulation 1. The Centre shall provide timely risk assessments, in accordance with Article 20 of Regulation (EU) …/… [OJ: Please insert the number of Regulation SCBTH [ISC/2020/12524]], in the case of a threat referred to in point (a) of Article 2(1) of that Regulation including a threat to substances of human origin, such as blood, organs, tissues and cells potentially impacted by communicable diseases, or point (d) of Article 2(1) of that Regulation.

Amendment 111

Proposal for a regulation

Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004

Article 8a — paragraph 1 a (new)

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

Amendment 112

Proposal for a regulation

Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004

Article 8a — paragraph 2

Text proposed by the Commission Amendment 2. The risk assessment shall include general and targeted recommendations for response as a basis for coordination in the HSC. 2. The risk assessments referred to in paragraph 1 shall include , where possible, general and targeted recommendations for response as a basis for coordination in the HSC , including, but not limited to: (a) a forecast of the evolution of a health crisis and the risk of a health emergency; (b) a forecast of the demand for medicines, vaccines, medical equipment, protective equipment and hospital capacity, including within the Union Civil Protection Mechanism; (c) identification of vulnerable groups in society, such as patients suffering from chronic conditions, patients with major non-communicable diseases, the elderly, children, pregnant women and professions with a high risk of infection or transmission, including specific needs for medicines and hospital capacity for those vulnerable groups; (d) identification of possible protective measures and assessment of their efficacy; (e) assessment of the possible need for activation of the EU Health Task Force .

Amendment 113

Proposal for a regulation

Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004

Article 8a — paragraph 3

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

Amendment 114

Proposal for a regulation

Article 1 — paragraph 1 — point 10

Regulation (EC) No 851/2004

Article 8a — paragraph 4 a (new)

Text proposed by the Commission Amendment 4a. The Centre shall work together with the Member States to improve their risk assessment capacity.

Amendment 115

Proposal for a regulation

Article 1 — paragraph 1 — point 11

Regulation (EC) No 851/2004

Article 8b — paragraph 1 — point a

Text proposed by the Commission Amendment (a) national responses to the serious cross-border threat to health; (a) national or interregional responses to the serious