P9_TA(2021)0377

Serious cross-border threats to health ***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 on serious cross-border threats to health repealing Decision No 1082/2013/EU (COM(2020)0727 — C9-0367/2020 — 2020/0322(COD)) (1)

(Ordinary legislative procedure: first reading)

(2022/C 117/23)

Amendment 1

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission Amendment (1a) The health provisions of the Treaties are still largely under-used in terms of the purposes they were designed to achieve. This Regulation should therefore be aimed at making the best possible use of such health provisions, in order to demonstrate the strength of the Union’s health policy, while preserving the normal functioning of the single market in the event serious cross-border threats to health arise.

Amendment 2

Proposal for a regulation

Recital 2

Text proposed by the Commission Amendment (2) In light of the lessons learnt during the ongoing COVID-19 pandemic and in order to facilitate adequate Union-wide preparedness and response to all cross-border threats to health, the legal framework for epidemiological surveillance, monitoring, early warning of, and combating serious cross-border threats to health, as set out in Decision No 1082/2013/EU, needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators, and cooperation by Member States with the European Centre for Disease Prevention and Control (ECDC). Moreover, in order to ensure effective Union response to novel cross- border threats to health, the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of EU reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. The capacity for contact tracing should be strengthened via the creation of an automated system, using modern technologies. (2) In light of the lessons learnt during the ongoing COVID-19 pandemic and in order to facilitate adequate Union-wide prevention of, preparedness and response to all cross-border threats to health , including zoonotic-related threats , the legal framework for epidemiological surveillance, monitoring, early warning of, and combating serious cross-border threats to health, as set out in Decision No 1082/2013/EU, needs to be broadened with regard to additional reporting requirements and analysis on health systems indicators, and cooperation between Member States , and Union agencies, particularly the European Centre for Disease Prevention and Control (ECDC ) and the European Medicines Agency (EMA), and international organisations, in particular the World Health Organization (WHO ). Moreover, in order to ensure effective Union response to novel cross- border threats to health, the legal framework to combat serious cross-border threats to health should enable to immediately adopt case definitions for the surveillance of novel threats and should provide for the establishment of a network of EU reference laboratories and a network to support monitoring of disease outbreaks that are relevant to substances of human origin. The capacity for contact tracing should be strengthened via the creation of an automated system that uses modern technologies, while respecting Regulation (EU) 2016/679 of the European Parliament and of the Council (‘GDPR’) (1a).

Amendment 3

Proposal for a regulation

Recital 3

Text proposed by the Commission Amendment (3) An important role in the coordination of preparedness and response planning for serious cross-border threats to health is being played by the Health Security Committee (HSC), as formally established by Decision No 1082/2013/EU. This Committee should be given additional responsibilities with regard to the adoption of guidance and opinions to better support Member States in the prevention and control of serious cross-border threats to health. (3) An important role in the coordination of prevention, preparedness and response planning for serious cross-border threats to health is being played by the Health Security Committee (HSC), as formally established by Decision No 1082/2013/EU. This Committee should be given additional responsibilities with regard to the adoption of guidance and opinions to better support Member States in the prevention and control of serious cross-border threats to health, and support better coordination between Member States to address those threats . Representatives designated by the European Parliament should be able to participate in the HSC as observers.

Amendment 4

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission Amendment (4a) Prevention and promotion strategies concern all sectoral policies including fiscal, commercial, economic, agro-environmental, educational, housing, cultural and relating to social assistance. ‘Health in all Policies’ should be a principle of all public policies. An instrument already used at the national level to assess the health impact of the different sectoral policies is the so-called Health Test. A Health impact assessment should be undertaken for all programmes managed by the Union.

Amendment 5

Proposal for a regulation

Recital 5

Text proposed by the Commission Amendment (5) This Regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods, which provide for special obligations and tools for monitoring, early warning and combatting specific threats of a cross-border nature. Those measures include, in particular, relevant Union legislation in the area of common safety concerns in public health matters, covering goods such as pharmaceutical products, medical devices and foodstuffs, substances of human origin (blood, tissues and cells, organs), and exposure to ionising radiation. (5) This Regulation should apply without prejudice to other binding measures concerning specific activities or quality and safety standards for certain goods, which provide for special obligations and tools for monitoring, early warning and combatting specific threats of a cross-border nature , such as the International Health Regulations (IHR) of the World Health Organization (WHO) . Those measures include, in particular, relevant Union legislation in the area of common safety concerns in public health and environmental matters, covering goods such as pharmaceutical products, medical devices , in vitro diagnostic medical devices, and foodstuffs, substances of human origin (blood , plasma , tissues and cells, organs), and exposure to ionising radiation.

Amendment 242

Proposal for a regulation

Recital 5 a (new)

Text proposed by the Commission Amendment (5a) 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 respect the principles of the ‘One Health’ approach to address current and emerging crises.

Amendment 6

Proposal for a regulation

Recital 6

Text proposed by the Commission Amendment (6) The protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States, should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the activities of which are relevant to the preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (‘EWRS’) set up by Decision No 2119/98/EC. (6) In line with the ‘One Health’ and ‘Health in all policies’ approaches, the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities . The Union should support Member States in reducing health inequalities, within and between Member States, in achieving universal health coverage and in addressing the challenges of vulnerable groups. The Union should also urge Member States to implement the health-specific country-specific recommendations and support Member States in strengthening the resilience, responsiveness and readiness of healthcare systems to address future challenges, including pandemics . In order to achieve a high level of human health protection, and to avoid any overlap of activities, duplication or conflicting actions, the Commission, in liaison with the Member States , and all relevant stakeholders, such as health professionals, patient associations, industry and supply chain actors , should ensure coordination and exchange of information between the mechanisms and structures established under this Regulation, and other mechanisms and structures established at Union level and under the Treaty establishing the European Atomic Energy Community (the Euratom Treaty), the activities of which are relevant to the preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. Those mechanisms should look for synergies between Union and national measures, while seeking to avoid duplicating measures undertaken in the context of the WHO framework. In particular, the Commission should ensure that relevant information from the various rapid alert and information systems at Union level and under the Euratom Treaty is gathered and communicated to the Member States through the Early Warning and Response System (‘EWRS’) set up by Decision No 2119/98/EC.

Amendment 7

Proposal for a regulation

Recital 7

Text proposed by the Commission Amendment (7) Preparedness and response planning are essential elements for effective monitoring, early warning of and combatting serious cross-border threats to health. As such, a Union health crisis and pandemic preparedness plan needs to be established by the Commission and approved by the HSC. This should be coupled with updates to Member States’ preparedness and response plans so as to ensure they are compatible within the regional level structures. To support Member States in this endeavour, targeted training and knowledge exchange activities for healthcare staff and public health staff should be provided knowledge and necessary skills should be provided by the Commission and Union Agencies . To ensure the putting into operation and the running of these plans, the Commission should conduct stress tests, exercises and in-action and after-action reviews with Member States. These plans should be coordinated, be functional and updated, and have sufficient resources for their operationalisation. Following stress tests and reviews of the plans, corrective actions should be implemented and the Commission should be kept informed of all updates. (7) Prevention, preparedness and response planning are essential elements for effective monitoring, early warning of and combatting serious cross-border threats to health. As such, a Union health crisis and pandemic preparedness plan needs to be established by the Commission and approved by the HSC. This should be coupled with updates to Member States’ prevention, preparedness and response plans so as to ensure they are compatible within the regional level structures. The plans should be implemented through interregional crisis anticipation planning with particular attention paid to cross-border regions to enhance their health cooperation. Where appropriate, regional authorities should participate in the drawing up of these plans. To support Member States in this endeavour, the Commission and Union agencies should provide targeted training and facilitate the sharing of best practices for healthcare staff and public health staff to improve their knowledge and ensure necessary skills. To ensure the putting into operation and the running of these plans, the Commission should conduct stress tests, exercises and in-action and after-action reviews with Member States. These plans should include recommendations for policy interventions related to mitigating the impact of communicable diseases on health services and care, including on major non-communicable diseases (NCDs). The plans should be coordinated, be functional and updated, and have sufficient resources for their operationalisation . Specific considerations should be given to border regions, where joint cross-border exercises should be promoted and health practitioners encouraged to gain familiarity with the public health systems in neighbouring countries . Following stress tests and reviews of the plans, corrective actions should be implemented and the Commission should be kept informed of all updates.

Amendment 8

Proposal for a regulation

Recital 8

Text proposed by the Commission Amendment (8) To this end, Member States should provide the Commission with an update on the latest situation with regard to their preparedness and response planning and implementation at national level. Information provided by the Member States should include the elements that Member States are obliged to report to the World Health Organization (WHO) in the context of the International Health Regulations (IHR) (15). In turn, the Commission should report to the European Parliament and to the Council on the state of play and progress with preparedness, response planning and implementation at Union level, including on corrective actions, every 2 years to ensure that national preparedness and response plans are adequate. In order to support the assessment of these plans, EU audits in Member States should be conducted, in coordination with the ECDC and Union agencies. Such planning should include in particular adequate preparedness of critical sectors of society, such as energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning. (8) To this end, Member States should provide the Commission with an update on the latest situation with regard to their prevention, preparedness and response planning and implementation at national level , and regional level where applicable . Information provided by the Member States should include the elements that Member States are obliged to report to the World Health Organization (WHO) in the context of the International Health Regulations (IHR) (15) . Access to timely and complete data is a precondition for rapid risk assessments and crisis mitigation. To avoid duplication of efforts and diverging recommendations, standardised definitions, where possible, and fluid information exchanges should take place between Union agencies, the WHO and national agencies . In turn, the Commission should report to the European Parliament and to the Council on the state of play and progress with prevention, preparedness, response planning and implementation at Union level, including on corrective actions, every year to ensure that national preparedness and response plans are adequate. In order to support the assessment of these plans, EU audits in Member States should be conducted, in coordination with the ECDC and Union agencies. Such planning should include in particular adequate preparedness of critical long-term healthcare and critical sectors of society, such as agriculture, energy, transport, communication or civil protection, which rely, in a crisis situation, on well-prepared gender-sensitive public health systems that are also in turn dependent on the functioning of those sectors and on maintenance of essential services at an adequate level. In the event of a serious cross-border threat to health originating from a zoonotic infection, it is important to ensure the interoperability between health and veterinary sectors for preparedness and response planning.

Amendment 9

Proposal for a regulation

Recital 8 a (new)

Text proposed by the Commission Amendment (8a) Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for further firmer action at Union level to support cooperation and coordination among the Member States, in particular between neighbouring border regions. The national plans of Member States sharing a border with at least one other Member State should therefore include plans to improve the preparedness for, prevention of and response to health crises in border areas in neighbouring regions, including through mandatory cross-border training for healthcare staff and coordination exercises for the medical transfer of patients. The Commission should regularly report on the state of play of cross-border crisis preparation in neighbouring regions.

Amendment 10

Proposal for a regulation

Recital 8 b (new)

Text proposed by the Commission Amendment (8b) The role of frontline health professionals has also become apparent during the pandemic as they have been key to ensuring access to medicine and continuity of care, providing moral support and being a source of trusted information against false information. For future emergencies, it is necessary to strengthen the knowledge of health professionals by laying down rules to provide training for workers in the fields of health care and public health. It is also necessary to integrate them through their professional organisations in the definition of public health policies as well as in the digital transformation in order to improve the quality and efficiency of health systems and ensure their sustainability for the health, social and territorial cohesion work they carry out.

Amendment 11

Proposal for a regulation

Recital 8 c (new)

Text proposed by the Commission Amendment (8c) Health literacy plays a fundamental role in preventing and mitigating the impact of cross-border threats and contributing to a better understanding on the part of the population of the countermeasures and risk assessment of different threats. Respiratory etiquette, correct hand washing, avoiding unnecessary close contact with anyone with flu-like symptoms, and avoiding unprotected contact with wild animals should be part of health education campaigns to improve the population's behaviour, based on the latest available evidence.

Amendment 12

Proposal for a regulation

Recital 8 d (new)

Text proposed by the Commission Amendment (8d) Building on lessons learnt from the COVID-19 pandemic, this Regulation should create a more robust mandate for coordination at Union level. The declaration of a Union emergency situation would trigger increased coordination and allow for timely development, stockpiling and joint procurement of medical countermeasures.

Amendment 13

Proposal for a regulation

Recital 8 e (new)

Text proposed by the Commission Amendment (8e) This Regulation also ensures coordinated action at Union level, in order to ensure that the internal market functions properly, and to ensure that basic supplies, including medicines, medical products and personal protective equipment (PPE) circulate freely.

Amendment 14

Proposal for a regulation

Recital 8 f (new)

Text proposed by the Commission Amendment (8f) Health logistics mechanisms should meet the specific legal requirements of Directive 2001/83/EC of the European Parliament and of the Council (1a) and Regulation (EU) 2017/745 of the European Parliament and of the Council (1b) .

Amendment 15

Proposal for a regulation

Recital 9

Text proposed by the Commission Amendment (9) As serious cross-border threats to health are not limited to Union borders, joint procurement of medical countermeasures should be extended to include European Free Trade Association States and Union candidate countries, in accordance with the applicable Union legislation. The Joint Procurement Agreement, determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU, should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the EU. The Commission should ensure coordination and information exchange between the entities organizing any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council (16). (9) As serious cross-border threats to health are not limited to Union borders, the Union should adopt a coordinated approach, characterised by solidarity and responsibility, in combatting such threats. The joint procurement of medical countermeasures should , therefore, be extended to include European Free Trade Association States, Union candidate countries , the Principality of Andorra, the Principality of Monaco, the Republic of San Marino and the Vatican City State , in accordance with the applicable Union legislation. Joint procurement of medical countermeasures would strengthen the negotiating position of participating countries, improve the security of supply and ensure equitable access to medical countermeasures. The functioning of the Joint Procurement Agreement and rescEU should abide by high standards of transparency, including in relation to the disclosure of the amounts ordered by and delivered to each participating country and details of their liabilities. The Joint Procurement Agreement, determining the practical arrangements governing the joint procurement procedure established under Article 5 of Decision No 1082/2013/EU, should also be adapted to include an exclusivity clause regarding negotiation and procurement for participating countries in a joint procurement procedure, to allow for better coordination within the EU. The exclusivity clause should entail that countries participating in the joint procurement procedure do not negotiate and sign parallel contracts with producers, and define clear consequences for those that do. The Commission should ensure coordination and information exchange between the entities organizing and participating in any action under different mechanisms established under this Regulation and other relevant Union structures related to procurement and stockpiling of medical countermeasures, such as the strategic rescEU reserve under Decision No 1313/2013/EU of the European Parliament and of the Council (16). The Member States should ensure a sufficient reserve of critical medical products to counter the risk of shortages of critical products.

Amendment 16

Proposal for a regulation

Recital 9 a (new)

Text proposed by the Commission Amendment (9a) Joint procurement should be based on shared responsibilities and a fair approach with rights and obligations for all parties involved. Clear commitments should be provided and respected, with manufacturers delivering the agreed production levels and the authorities purchasing their agreed reserved volumes.

Amendment 17

Proposal for a regulation

Recital 9 b (new)

Text proposed by the Commission Amendment (9b) In times of crisis, temporary measures should be introduced by the Commission to mitigate shortages and facilitate the circulation of medicines between Member States, including the acceptance of different packaging formats, a reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, extending the validity of good manufacturing practices certificates, longer expiry periods, and the use of veterinary medicinal products. The Commission should strictly monitor the use of such measures, to ensure that patient safety is not compromised and to keep medicines available in the event of difficulties or shortages.

Amendment 18

Proposal for a regulation

Recital 9 c (new)

Text proposed by the Commission Amendment (9c) Joint procurement should be carried out in a transparent, timely and effective way. In this respect, clear and transparent stages for the process, scope, tender, specifications, timelines and formalities should be defined. A preliminary consultation phase, subject to adequate safeguards against conflict of interest and asymmetry of information, involving relevant actors should be guaranteed, as well as two-way communication throughout the procedure.

Amendment 19

Proposal for a regulation

Recital 9 d (new)

Text proposed by the Commission Amendment (9d) The Commission should pay special attention to ensuring that joint procurement of medical countermeasures within the meaning of Article 12 also includes procurement of orphan drugs.

Amendment 20

Proposal for a regulation

Recital 9 e (new)

Text proposed by the Commission Amendment (9e) If joint procurement is deployed, the awarding process should take into account qualitative criteria, such as the ability of the manufacturer to ensure security of supply during a health crisis, as well as price.

Amendment 21

Proposal for a regulation

Recital 9 f (new)

Text proposed by the Commission Amendment (9f) In order to achieve transparency, the European Parliament should scrutinise contracts concluded under the Joint Procurement Procedure. The Commission should provide to the Parliament complete, timely and accurate information on the ongoing negotiations and give access to the tender documents as well as to the contracts concluded.

Amendment 22

Proposal for a regulation

Recital 9 g (new)

Text proposed by the Commission Amendment (9g) Where a joint procurement procedure has not been used to purchase medical countermeasures, the Commission should encourage Member States to exchange information on pricing and delivery dates of medical countermeasures, to provide an increased level of transparency and thus allow Member States to access and negotiate medical countermeasures in more equitable conditions.

Amendment 23

Proposal for a regulation

Recital 9 h (new)

Text proposed by the Commission Amendment (9h) In times of crisis, other mechanisms should be used to enable global response and crises mitigation. Such mechanisms could, for example, include a Union export control mechanism, enhanced cooperation agreements on the production of medical countermeasures, pre-allocating part of the Union joint procurement, and both voluntary and compulsory technology know-how pools and licensing agreements between companies, which should facilitate access to counter-measures for people, including those in Eastern Partnership and low- and middle-income countries.

Amendment 24

Proposal for a regulation

Recital 10

Text proposed by the Commission Amendment (10) Unlike for communicable diseases, the surveillance of which at Union level is carried out on a permanent basis by the ECDC, other potentially serious cross-border threats to health do not currently necessitate monitoring by EU Agencies. A risk-based approach, whereby monitoring is carried out by Member States and available information is exchanged through EWRS, is therefore more appropriate for such threats. (10) Unlike for communicable diseases, the surveillance of which at Union level is carried out on a permanent basis by the ECDC, other potentially serious cross-border threats to health do not currently necessitate monitoring by EU Agencies. A risk-based approach, whereby monitoring is carried out by Member States and available information is exchanged through EWRS, is therefore more appropriate for such threats. Nevertheless, the ECDC should have the ability to monitor the impact of communicable diseases on major non-communicable diseases, including mental diseases, assessing the continuity of screening, diagnosis, monitoring, treatment and care in the healthcare system, in coordination with existing data sets, tools and registers.

Amendment 25

Proposal for a regulation

Recital 11

Text proposed by the Commission Amendment (11) The Commission should strengthen cooperation and activities with the Member States, the ECDC, the European Medicines Agency (‘EMA’), other Union Agencies, research infrastructures and the WHO to improve the prevention of communicable diseases, such as vaccine preventable diseases, as well as other health issues, such as antimicrobial resistance. (11) The Commission should strengthen cooperation and activities with the Member States, the ECDC, the European Medicines Agency (‘EMA’), other Union Agencies, research infrastructures and the WHO to improve , through the One Health approach, the prevention of communicable diseases, such as vaccine preventable diseases, as well as other health issues, such as antimicrobial resistance , and other major non-communicable diseases . During health crises, particular attention should be paid to the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions, and to the mental health implications of the crisis and psychosocial needs of the population.

Amendment 26

Proposal for a regulation

Recital 12

Text proposed by the Commission Amendment (12) In case of cross-border health threats due to a communicable disease, 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 in return are dependent on rapid risk assessments by the ECDC to safeguard patients, in need of a therapy from a substance of human origin, from a transmission of such communicable disease. Such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. The ECDC should therefore set up and operate a network of national blood and transplant services and their authorities to serve this dual purpose. (12) In case of cross-border health threats due to a communicable disease, the blood and transplant services , pharmacies and other licensed health care establishments 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 in return are dependent on rapid risk assessments by the ECDC to safeguard patients, in need of a therapy from a substance of human origin or undergoing a process of medically assisted reproduction from a transmission of such communicable disease. Such risk assessment serves then as basis to allow for the appropriate adaptation of measures setting standards for quality and safety of such substances of human origin. The ECDC should therefore set up and operate a network of national blood and transplant services and their authorities , as well as pharmacy services and other licensed health services and establishments, to serve this dual purpose.

Amendment 27

Proposal for a regulation

Recital 12 a (new)

Text proposed by the Commission Amendment (12a) In order to improve early preparedness for, and response to, the emergence of cross-border health threats, it is crucial to enable continuous and rapid access to data on the availability of the necessary medical countermeasures. Therefore, a network of Member States' services providing up-to-date information on national strategic stockpiles and the availability of medical countermeasures, stockpiles of medical products, essential health products and diagnostic tests should be established, operated and coordinated at Union level. Strengthening coordination and exchange of information with Member States on strategic stockpiles and medical countermeasures available is necessary to enhance the collection, modelling and use of prospective data that allow early alert notifications in the Union.

Amendment 28

Proposal for a regulation

Recital 13

Text proposed by the Commission Amendment (13) A system enabling the notification at Union level of alerts related to serious cross-border threats to health has been put in place by Decision No 2119/98/EC in order to ensure that competent public health authorities in Member States and the Commission are duly informed in a timely manner. All serious cross-border threats to health covered by this Regulation are covered by the EWRS. The operation of the EWRS should remain within the remit of the ECDC. The notification of an alert should be required only where the scale and severity of the threat concerned are or could become so significant that they affect or could affect more than one Member State and require or could require a coordinated response at the Union level. To avoid duplication and ensure coordination across Union alert systems, the Commission and ECDC should ensure that alert notifications under the EWRS and other rapid alert systems at Union level are linked to each other to the extent possible so that the competent authorities of the Member States can avoid as much as possible notifying the same alert through different systems at Union level and can benefit from receiving all-hazard alerts from a single coordinated source. (13) A system enabling the notification at Union level of alerts related to serious cross-border threats to health has been put in place by Decision No 2119/98/EC in order to ensure that competent public health authorities in Member States and the Commission are duly informed in a timely manner. All serious cross-border threats to health covered by this Regulation are covered by the EWRS. The operation of the EWRS should remain within the remit of the ECDC. The notification of an alert should be required only where the scale and severity of the threat concerned are or could become so significant that they affect or could affect more than one Member State and require or could require a coordinated response at the Union level. To avoid duplication and ensure coordination across Union alert systems, the Commission and ECDC should ensure that alert notifications under the EWRS and other rapid alert systems at Union level are fully interoperable and, subject to human oversight, automatically linked to each other to the extent possible so that the competent authorities of the Member States can avoid as much as possible notifying the same alert through different systems at Union level and can benefit from receiving all-hazard alerts from a single coordinated source.

Amendment 29

Proposal for a regulation

Recital 14

Text proposed by the Commission Amendment (14) In order to ensure that the assessment of risks to public health at the Union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective, the available scientific expertise should be mobilised in a coordinated manner, through appropriate channels or structures depending on the type of threat concerned. That assessment of risks to public health should be developed by means of a fully transparent process and should be based on principles of excellence, independence, impartiality and transparency. The involvement of Union agencies in these risk assessments needs to be broadened according to their speciality in order to ensure an all hazard approach, via a permanent network of agencies and relevant Commission services to support the preparation of risk assessments. (14) In order to ensure that the assessment of risks to public health at the Union level from serious cross-border threats to health is consistent as well as comprehensive from a public health perspective, the available scientific expertise should be mobilised in a coordinated and multidisciplinary manner, through appropriate channels or structures depending on the type of threat concerned. That assessment of risks to public health should be developed by means of a fully transparent process and should be based on principles of excellence, independence, impartiality and transparency. The involvement of Union agencies and bodies in these risk assessments needs to be broadened according to their speciality in order to ensure an all hazard approach, via a permanent network of agencies and relevant Commission services to support the preparation of risk assessments. In order to achieve a sufficient degree of expertise and effectiveness, the financial and human resources of Union agencies and bodies should be increased.

Amendment 30

Proposal for a regulation

Recital 14 a (new)

Text proposed by the Commission Amendment (14a) Member States, the Commission and Union agencies, while applying the One Health approach, should identify recognised public health organisations and experts, both in the area of communicable and major non-communicable diseases, and other relevant stakeholders across sectors, available to assist in Union responses to health threats. Such experts and stakeholders, including civil society organisations, should be structurally engaged throughout all crisis response activities and contribute to the decision-making processes. National authorities should also consult and involve representatives of patient organisations and national social partners in the healthcare and social services sector in the implementation of this regulation where appropriate. It is essential that there be full compliance with transparency and conflict of interest rules for stakeholder engagement.

Amendment 31

Proposal for a regulation

Recital 14 b (new)

Text proposed by the Commission Amendment (14b) Green lanes should only be considered as an appropriate tool for pandemic situations of a declared public health emergency where they are aimed at ensuring that essential goods, medical countermeasures and cross border workers circulate freely and safely within the internal market. The creation of green lanes in such situations should not affect the relevant treaty provisions or legislation regulating border controls.

Amendment 32

Proposal for a regulation

Recital 15 a (new)

Text proposed by the Commission Amendment (15a) The Commission should ensure that, at the time of the declaration of a state of emergency, the number of accommodation facilities in hospitals in the Member States, as well as the number of available accommodation units in intensive care units in the Member States, are known, for the purpose of cross-border movement of patients.

Amendment 33

Proposal for a regulation

Recital 16 a (new)

Text proposed by the Commission Amendment (16a) Regular dialogue and exchange of information between authorities, industry, relevant entities of the pharmaceutical supply chain, healthcare professionals' and patients' organisations should also be ensured, in order to start early discussions about expected potential serious cross-border threats to health in the market, by way of sharing information about expected supply constraints or raising specific clinical needs, thereby allowing better coordination, synergies and appropriate reaction when needed.

Amendment 34

Proposal for a regulation

Recital 17

Text proposed by the Commission Amendment (17) Inconsistent communication with the public and stakeholders such as healthcare professionals can have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators. The coordination of the response within the HSC, assisted by relevant subgroups, should, therefore, encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication, based on robust and independent evaluation of public health risks, to be adapted to national needs and circumstances. Such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals. Given the cross-sectoral nature of this type of crises, coordination should also be ensured with other relevant constituencies, such as the Union Civil Protection Mechanism established by Decision (EU) 2019/420 of the European Parliament and of the Council (17). (17) Inconsistent communication with the public and stakeholders such as healthcare and public health professionals can have a negative impact on the effectiveness of the response from a public health perspective as well as on economic operators. The coordination of the response within the HSC, assisted by relevant subgroups, should, therefore, encompass rapid information exchange concerning communication messages and strategies and addressing communication challenges with a view to coordinating risk and crisis communication, based on holistic, robust and independent evaluation of public health risks, to be adapted to national and regional needs and circumstances . In those Member States with regions having health competences, those regions should provide this information . Such exchanges of information are intended to facilitate the monitoring of the clarity and coherence of messages to the public and to healthcare professionals . Following its recommendations to Member States and healthcare professionals, the ECDC should broaden its communication activity to include the general public by establishing and managing an online portal to share verified information and fight against disinformation . Given the cross-sectoral nature of this type of crises, coordination should also be ensured with other relevant constituencies, such as the Union Civil Protection Mechanism established by Decision (EU) 2019/420 of the European Parliament and of the Council (17).

Amendment 35

Proposal for a regulation

Recital 18

Text proposed by the Commission Amendment (18) The recognition of public health emergency situations and the legal effects of this recognition provided by Decision No 1082/2013/EU should be broadened. To this end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level. In order to recognise such an emergency situation, the Commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of this emergency recognition. The advisory committee should consist of independent experts, selected by the Commission from the fields of expertise and experience most relevant to the specific threat that is occurring, representatives of the ECDC, of the EMA, and of other Union bodies or agencies as observers. Recognition of a public health emergency at Union level will provide the basis for introducing operational public health measures for medical products and medical devices, flexible mechanisms to develop, procure, manage and deploy medical countermeasures as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’. (18) The recognition of public health emergency situations and the legal effects of this recognition provided by Decision No 1082/2013/EU should be broadened. To this end, this Regulation should allow for the Commission to formally recognise a public health emergency at Union level. In order to recognise such an emergency situation, the Commission should establish an independent advisory committee that will provide expertise on whether a threat constitutes a public health emergency at Union level, and advise on public health response measures and on the termination of this emergency recognition. The advisory committee should consist of independent experts, representatives of health and care workers, including nurses and medical doctors, and representatives of civil society, selected by the Commission from the fields of expertise and experience most relevant to the specific threat that is occurring, representatives of the ECDC, of the EMA, and of other Union bodies or agencies as observers. All members of the Advisory Committee should provide declarations of interest. The advisory committee should work in close cooperation with national advisory bodies. Recognition of a public health emergency at Union level will provide the basis for introducing operational public health measures for medical products and medical devices , Union export control mechanisms , flexible mechanisms to develop, procure, manage and deploy medical countermeasures as well as the activation of support from the ECDC to mobilise and deploy outbreak assistance teams, known as ‘EU Health Task Force’.

Amendment 36

Proposal for a regulation

Recital 20

Text proposed by the Commission Amendment (20) The occurrence of an event that corresponds to serious cross-border threats to health and is likely to have Union-wide consequences should require the Member States concerned to take particular control or contact-tracing measures in a coordinated manner in order to identify people already contaminated and those persons exposed to risk. Such cooperation could require the exchange of personal data through the system, including sensitive information related to health and information about confirmed or suspected human cases of the disease, between those Member States directly involved in the contact-tracing measures. The exchange of personal data concerning health by the Member States has to comply with Article 9(2)(i) of Regulation (EU) 2016/679 of the European Parliament and of the Council (18). (20) The occurrence of an event that corresponds to serious cross-border threats to health and is likely to have Union-wide consequences should require the Member States concerned or potentially concerned to take particular control or contact-tracing measures in a coordinated manner in order to identify people already contaminated and those persons exposed to risk. Such cooperation could require the exchange of personal data through the system, including sensitive information related to health and information about confirmed or suspected human cases of the disease or infection , between those Member States directly involved in the contact-tracing measures. The exchange of personal data concerning health by the Member States has to comply with Article 9(2)(i) of Regulation (EU) 2016/679 of the European Parliament and of the Council (18).

Amendment 37

Proposal for a regulation

Recital 21

Text proposed by the Commission Amendment (21) Cooperation with third countries and international organisations in the field of public health should be fostered. It is particularly important to ensure the exchange of information with the WHO on the measures taken pursuant to this Regulation. This reinforced cooperation is also required to contribute to EU’s commitment to strengthening support to health systems and reinforcing partners’ preparedness and response capacity. The Union could benefit from concluding international cooperation agreements with third countries or international organisations, including the WHO, to foster the exchange of relevant information from monitoring and alerting systems on serious cross-border threats to health. Within the limits of the Union’s competences, such agreements could include, where appropriate, the participation of such third countries or international organisations in the relevant epidemiological surveillance monitoring network and the EWRS, exchange of good practice in the areas of preparedness and response capacity and planning, public health risk-assessment and collaboration on response coordination, including the research response. (21) Cooperation with third countries and international organisations in the field of public health should be fostered. It is particularly important to ensure the exchange of information with the WHO on the measures taken pursuant to this Regulation. This reinforced cooperation is also required to contribute to EU’s commitment to strengthening support to health systems and reinforcing partners’ preparedness and response capacity. The Union could benefit from concluding international cooperation agreements with third countries or international organisations, including the WHO, to foster the exchange of relevant information from monitoring and alerting systems on serious cross-border threats to health. Within the limits of the Union’s competences, such agreements could include, where appropriate, the participation of such third countries or international organisations in the relevant epidemiological surveillance monitoring network , such as the European Surveillance System (TESSy), and the EWRS, exchange of good practice in the areas of preparedness and response capacity and planning, public health risk-assessment and collaboration on response coordination, including the research response. The Commission and the Member States should actively work towards the establishment of a WHO framework convention on pandemic preparedness and response, which should lay down principles and priorities for pandemic preparedness and response. Such a framework convention should facilitate the implementation of the International Health Regulations (2005) (1a) and should support the strengthening of the international health framework and the improvement of cooperation with regard to early detection, prevention, response and resilience in respect of future pandemics.

Amendment 38

Proposal for a regulation

Recital 22

Text proposed by the Commission Amendment (22) The processing of personal data for the purpose of implementing this Regulation should comply with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of the European Parliament and of the Council (19). In particular, the operation of the EWRS should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by Member States at national level. In this regard, the EWRS includes a messaging function in which personal data, including contact and health data, can be communicated to relevant authorities involved in contact tracing measures. (22) Due to the sensitive nature of health data, Member States, the Commission and Union agencies should safeguard and guarantee that their processing operations respect the data protection principles in accordance with Article 5 of the GDPR. The processing of personal data for the purpose of implementing this Regulation should comply with the GDPR and Regulation (EU) 2018/1725 of the European Parliament and of the Council (19). In particular, the operation of the EWRS should provide for specific safeguards for the safe and lawful exchange of personal data for the purpose of contact tracing measures implemented by Member States at national level. In this regard, the EWRS includes a messaging function in which personal data, including contact and health data, can be communicated to relevant authorities involved in contact tracing . Regulation (EU) 2018/1725 of the European Parliament and of the Council should be strictly respected and appropriate technical and organisational security measures , in accordance with that Regulation, should be put in place .

Amendment 39

Proposal for a regulation

Recital 25

Text proposed by the Commission Amendment (25) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt implementing acts in relation to: templates to be used when providing the information on preparedness and response planning; organisation of the training activities for health care and public health staff; the establishment and update of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance and the procedures for the operation of such a network; the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and, where necessary, for other serious cross-border threats to health subject to ad hoc monitoring; the procedures for the operation of the EWRS; the functioning of the surveillance platform ; the designation of EU reference laboratories to provide support to national reference laboratories; the procedures for the information exchange on and the coordination of the responses of the Member States; the recognition of situations of public health emergency at Union level and the termination of such a recognition and procedures necessary to ensure that the operation of the EWRS and the processing of data are in accordance with the data protection legislation. (25) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to adopt implementing acts in relation to: templates to be used when providing the information on preparedness and response planning; organisation of the training activities for health care and public health staff; the establishment and update of a list of communicable diseases and related special health issues subject to the procedures for the operation of the network of epidemiological surveillance; the designation of EU reference laboratories to provide support to national and regional reference laboratories; the procedures for the information exchange on and the coordination of the responses of the Member States; the recognition of situations of public health emergency at Union level and the termination of such a recognition and procedures necessary to ensure that the operation of the EWRS and the processing of data are in accordance with the data protection legislation.

Amendment 40

Proposal for a regulation

Recital 28

Text proposed by the Commission Amendment (28) In order to ascertain the state of implementation of the national preparedness plans and their coherence with the Union plan, 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 procedures, standards and criteria for the audits aimed at the assessment of preparedness and response planning at national level. 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 on Better Law-Making of 13 April 2016 (21). 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. (28) In order to supplement certain aspects of this Regulation and to ascertain the state of implementation of the national and regional preparedness plans and their coherence with the Union plan, 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: the establishment and updating of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance; the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and, where necessary, for other serious cross-border threats to health that are the subject of ad hoc monitoring; the requirements necessary to ensure the compliance of the operation of the EWRS and the processing of data with the relevant Regulations; the establishment and updating of a list of relevant health data to be automatically collected by a digital platform, subject to human oversight; the functioning of the surveillance platform; and the procedures, standards and criteria for the audits aimed at the assessment of preparedness and response planning at national and regional level. 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 on Better Law-Making of 13 April 2016 (21). 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 41

Proposal for a regulation

Recital 28 a (new)

Text proposed by the Commission Amendment (28a) In respect of the establishment and updating of a list of communicable diseases and related special health issues subject to the network of epidemiological surveillance and the procedures for the operation of such a network, the adoption of case definitions for those communicable diseases and special health issues covered by the epidemiological surveillance network and the case definitions to be used for ad hoc monitoring, the Commission should adopt delegated acts under the urgency procedure where duly justified imperative grounds of urgency related to the severity or novelty of a serious cross-border threat to health or to the rapidity of its spread between the Member States so require.

Amendment 42

Proposal for a regulation

Article 1 — paragraph 1 — point c

Text proposed by the Commission Amendment (c) joint procurement of medical countermeasures; (c) joint procurement , management and deployment of medical countermeasures;

Amendment 43

Proposal for a regulation

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

Text proposed by the Commission Amendment (ba) a network of national strategic stockpiles and available medical countermeasures;

Amendment 44

Proposal for a regulation

Article 1 — paragraph 3

Text proposed by the Commission Amendment 3. The implementation of this Regulation shall be supported by funding from relevant Union programmes and instruments. 3. In keeping with the ‘One Health’ and ‘Health in all policies’ approaches, the implementation of this Regulation shall be supported by funding from relevant Union programmes and instruments. The strengthened Union health framework addressing serious cross-border health threats shall work in synergy with and in a manner that is complementary to other Union policies and funds, such as actions implemented under the EU4Health programme, the European Structural and Investment Funds (ESIF), Horizon Europe, the Digital Europe Programme, rescEU reserve, the European Social Fund Plus (ESF+), the Emergency Support Instrument (ESI) and the Single Market Programme (SMP).

Amendment 45

Proposal for a regulation

Article 1 — paragraph 3 a (new)

Text proposed by the Commission Amendment 3a. This Regulation shall ensure that in future health emergencies, the detection of, health interventions concerning and treatment of other serious diseases are not halted.

Amendment 46

Proposal for a regulation

Article 1 — paragraph 3 b (new)

Text proposed by the Commission Amendment 3b. This Regulation shall be implemented with full respect for the dignity and fundamental rights and freedoms of persons.

Amendment 243

Proposal for a regulation

Article 2 — paragraph 1 — point a — point i

Text proposed by the Commission Amendment (i) communicable diseases; (i) communicable diseases , including those of zoonotic origin ;

Amendment 47

Proposal for a regulation

Article 2 — paragraph 2

Text proposed by the Commission Amendment 2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues. 2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases , the monitoring of the impact of such diseases on major non-communicable diseases and on related special health issues , such as mental health, and the impact on deferred screening, diagnosis, monitoring, treatment and care for other diseases and conditions .

Amendment 48

Proposal for a regulation

Article 2 — paragraph 3 a (new)

Text proposed by the Commission Amendment 3a. This Regulation shall promote the implementation of the International Health Regulations, reduce administrative burden and duplication of resources, and strengthen the gaps exposed during the COVID-19 pandemic in the prevention of, preparedness for and response to public health threats.

Amendment 49

Proposal for a regulation

Article 2 — paragraph 4

Text proposed by the Commission Amendment 4. In exceptional emergency situations, a Member State or the Commission may request the coordination of response within the HSC as referred to in Article 21, for serious cross-border threats to health other than those referred to in Article 2(1), if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health. 4. In exceptional emergency situations, a Member State or the Commission may request the coordination of response within the HSC as referred to in Article 21, for serious cross-border threats to health other than those referred to in Article 2(1), especially in relation to major non-communicable diseases, if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health.

Amendment 50

Proposal for a regulation

Article 2 — paragraph 5

Text proposed by the Commission Amendment 5. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the mechanisms and structures established under this Regulation and similar mechanisms and structures established at Union level or under the Euratom Treaty whose activities are relevant for preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health. 5. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the mechanisms and structures established under this Regulation and similar mechanisms and structures established at international level, Union level or under the Euratom Treaty whose activities are relevant for preparedness and response planning, monitoring, early warning of, and combating serious cross-border threats to health.

Amendment 51

Proposal for a regulation

Article 2 — paragraph 6

Text proposed by the Commission Amendment 6. Member States shall retain the right to maintain or introduce additional arrangements, procedures and measures for their national systems in the fields covered by this Regulation, including arrangements provided for in existing or future bilateral or multilateral agreements or conventions, on condition that such additional arrangements, procedures and measures do not impair the application of this Regulation. 6. Member States shall retain the right to maintain or introduce additional arrangements, procedures and measures for their national systems in the fields covered by this Regulation, including arrangements provided for in existing or future bilateral or multilateral agreements or conventions, on condition that such additional arrangements, procedures and measures do not impair the application of this Regulation. The Union shall call for the establishment of a WHO framework convention on pandemic preparedness and response. That convention shall be such as to facilitate the implementation of the International Health Regulation (2005) (1a) and resolve the weaknesses of that Regulation, identified during the COVID-19 crisis.

Amendment 52

Proposal for a regulation

Article 2 — paragraph 6 a (new)

Text proposed by the Commission Amendment 6a. This Regulation shall also apply, where appropriate, to regional competent authorities, systems and programmes in the fields covered by this Regulation.

Amendment 53

Proposal for a regulation

Article 3 — paragraph 1 — point 3

Text proposed by the Commission Amendment (3) ‘contact tracing’ means measures implemented in order to trace persons who have been exposed to a source of a serious cross-border threat to health, and who are in danger of developing or have developed a disease, through manual or other technological means; (3) ‘contact tracing’ means measures to identify, assess and manage persons who have been exposed to a source of a serious cross-border threat to health, and who are in danger of being infected or being infectious or who have developed a communicable disease, through manual or other technological means , with the sole objective of rapidly identifying potentially newly infected persons who may have come into contact with existing cases, in order to reduce further onward transmission ;

Amendment 54

Proposal for a regulation

Article 3 — paragraph 1 — point 4

Text proposed by the Commission Amendment (4) ‘epidemiological surveillance’ means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on communicable diseases and related special health issues; (4) ‘epidemiological surveillance’ means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on communicable diseases , the monitoring of the impact of such diseases on major non-communicable diseases, such as those relating to mental health, and on related special health issues;

Amendment 55

Proposal for a regulation

Article 3 — paragraph 1 — point 5 a (new)

Text proposed by the Commission Amendment (5a) ‘One Health approach’ means a multisectoral approach which recognises that human health is connected to animal health and to the environment, and that actions to tackle threats to health must take into account those three dimensions;

Amendment 56

Proposal for a regulation

Article 3 — paragraph 1 — point 5 b (new)

Text proposed by the Commission Amendment (5b) ‘Health in All Policies’ means an approach to the development, implementation and review of public policies, regardless of the sector, whereby the health implications of decisions are taken into account, and which seeks to achieve synergies and to avoid harmful health impacts being caused by such policies, in order to improve the health of the population and health equity;

Amendment 57

Proposal for a regulation

Article 3 — paragraph 1 — point 7 a (new)

Text proposed by the Commission Amendment (7a) ‘major non-communicable disease’ means a disease as defined in point (4a) of Article 2 of Regulation (EU) [ECDC regulation, correct reference to be inserted];

Amendment 58

Proposal for a regulation

Article 3 — paragraph 1 — point 8

Text proposed by the Commission Amendment (8) ‘medical countermeasure’ means medicinal products for human use and medical devices as defined in Directive 2001/83/EC of the European Parliament and of the Council (23) and in Regulation (EU) 2017/745 of the European Parliament and of the Council (24) or other goods or services for the for the purpose of preparedness and response to a serious cross-border threat to health. (8) ‘medical countermeasure’ means medicinal products for human use and medical devices as defined in Directive 2001/83/EC of the European Parliament and of the Council (23) and in Regulation (EU) 2017/745 of the European Parliament and of the Council (24) or other goods or services for the purpose of facilitating diagnosis and treatment in the framework of preparedness and response to a serious cross-border threat to health.

Amendment 59

Proposal for a regulation

Article 3 — paragraph 1 — point 8 a (new)

Text proposed by the Commission Amendment (8a ) ‘International Health Regulations’ mean the International Health Regulations adopted by the World Health Organization in 2005;

Amendment 60

Proposal for a regulation

Article 3 — paragraph 1 — point 8 b (new)

Text proposed by the Commission Amendment (8b) ‘ medical device’ means both a medical device as defined in point (1) of Article 2 of Regulation (EU) 2017/745, read in conjunction with point (2) of Article 1 and point (a) of Article 1(6) of that Regulation, and an in vitro diagnostic medical device as defined in point (2) of Article 2 of Regulation (EU) 2017/746;

Amendment 61

Proposal for a regulation

Article 3 — paragraph 1 — point 8 c (new)

Text proposed by the Commission Amendment (8c) ‘green lanes’ means passable and safe transit corridors that preserve supply chains in the event of a declared public health emergency at Union level in a pandemic situation by ensuring that essential goods, medical countermeasures and cross border workers can circulate freely and safely within the internal market, while fully respecting Article 77 (2)(e) TFEU.

Amendment 62

Proposal for a regulation

Article 4 — paragraph 1 a (new)

Text proposed by the Commission Amendment 1a. Representatives of relevant Union agencies shall participate in HSC meetings as observers.

Amendment 63

Proposal for a regulation

Article 4 — paragraph 2 — point b

Text proposed by the Commission Amendment (b) coordination in liaison with the Commission of the preparedness and response planning of the Member States in accordance with Article 10; (b) coordination in liaison with the Commission and relevant Union agencies of the prevention, preparedness and response planning of the Member States in accordance with Article 10;

Amendment 64

Proposal for a regulation

Article 4 — paragraph 2 — point c

Text proposed by the Commission Amendment (c) coordination in liaison with the Commission of the risk and crisis communication and responses of the Member States to serious cross-border threats to health, in accordance with Article 21; (c) coordination in liaison with the Commission and relevant Union agencies of the risk and crisis communication and responses of the Member States to serious cross-border threats to health, in accordance with Article 21;

Amendment 65

Proposal for a regulation

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

Text proposed by the Commission Amendment (da) adoption, on an annual basis, of an action programme to clearly set its priorities and objectives at the high level working group and the technical working group levels.

Amendment 66

Proposal for a regulation

Article 4 — paragraph 4

Text proposed by the Commission Amendment 4. The HSC shall be chaired by a representative of the Commission. The HSC shall meet at regular intervals and whenever the situation requires, on a request from the Commission or a Member State. 4. The HSC shall be chaired by a representative of the Commission without the right to vote . The HSC shall meet at regular intervals and whenever the situation requires, on a request from the Commission or a Member State.

Amendment 67

Proposal for a regulation

Article 4 — paragraph 5 a (new)

Text proposed by the Commission Amendment 5a. Members of the HSC and the Commission shall ensure thorough consultation with relevant Union agencies, public health experts, international organisations and stakeholders, including healthcare professionals.

Amendment 68

Proposal for a regulation

Article 4 — paragraph 7 a (new)

Text proposed by the Commission Amendment 7a. The European Parliament shall designate representatives to participate in the Health Security Committee (‘HSC’) as observers.

Amendment 69

Proposal for a regulation

Article 4 — paragraph 7 b (new)

Text proposed by the Commission Amendment 7b. The list of members of the HSC at both the political and technical levels shall be made public on the Commission and Council websites. Members of the Committee shall have no financial or other interests that could affect their impartiality. They shall act in the public interest and in an independent manner and make an annual declaration of their financial interests. All direct interests which could relate to the medical or another relevant sector shall be entered in a register held by the Commission and be accessible to the public, upon request.

Amendment 70

Proposal for a regulation

Article 4 — paragraph 7 c (new)

Text proposed by the Commission Amendment 7c. The rules of procedure, guidance, agendas and minutes of the meetings of the HSC shall be published on the Commission’s web-portal.

Amendment 71

Proposal for a regulation

Chapter II — title

Text proposed by the Commission Amendment

Amendment 72

Proposal for a regulation

Article 5 — title

Text proposed by the Commission Amendment Union preparedness and response plan Union prevention, preparedness and response plan

Amendment 73

Proposal for a regulation

Article 5 — paragraph 1

Text proposed by the Commission Amendment 1. The Commission, in cooperation with Member States and the relevant Union agencies, shall establish a Union health crisis and pandemic plan (‘the Union preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at Union level. 1. The Commission, in cooperation with Member States and the relevant Union agencies and taking into account the WHO framework , shall establish a Union health crisis and pandemic plan (‘the Union prevention , preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at Union level.

Amendment 74

Proposal for a regulation

Article 5 — paragraph 2

Text proposed by the Commission Amendment 2. The Union preparedness and response plan shall complement the national preparedness and response plans established in accordance with Article 6. 2. The Union prevention, preparedness and response plan shall complement the national preparedness and response plans established in accordance with Article 6.

Amendment 75

Proposal for a regulation

Article 5 — paragraph 3 — introductory part

Text proposed by the Commission Amendment 3. The Union preparedness and response plan shall, in particular, include arrangements for governance, capacities and resources for: 3. The Union prevention, preparedness and response plan shall, in particular, include arrangements for governance, capacities and resources for:

Amendment 76

Proposal for a regulation

Article 5 — paragraph 3 — point c

Text proposed by the Commission Amendment (c) the epidemiological surveillance and monitoring; (c) the epidemiological surveillance and monitoring , as well as the impact of communicable diseases on major non-communicable diseases ;

Amendment 77

Proposal for a regulation

Article 5 — paragraph 3 — point e

Text proposed by the Commission Amendment (e) the risk and crisis communication; (e) the risk and crisis communication , aimed at health professionals and at citizens ;

Amendment 78

Proposal for a regulation

Article 5 — paragraph 3 — point f a (new)

Text proposed by the Commission Amendment (fa) the mapping of the production capacities of medical products in the Union as a whole;

Amendment 79

Proposal for a regulation

Article 5 — paragraph 3 — point f b (new)

Text proposed by the Commission Amendment (fb) the establishment of a Union stock of critical medicinal products, medical countermeasures and personal protective equipment as part of the rescEU emergency reserve;

Amendment 80

Proposal for a regulation

Article 5 — paragraph 3 — point g a (new)

Text proposed by the Commission Amendment (ga) the criteria for activating and deactivating the actions;

Amendment 81

Proposal for a regulation

Article 5 — paragraph 3 — point g b (new)

Text proposed by the Commission Amendment (gb) ensuring that healthcare services, including the screening, diagnosis, monitoring, treatment and care for other diseases and conditions, are provided without disruption during health emergencies;

Amendment 82

Proposal for a regulation

Article 5 — paragraph 3 — point g c (new)

Text proposed by the Commission Amendment (gc) ensuring that national health systems are inclusive and provide equal access to health and related services, and that quality treatments are available without delays;

Amendment 83

Proposal for a regulation

Article 5 — paragraph 3 — point g d (new)

Text proposed by the Commission Amendment (gd) an adequate and needs-oriented staffing level;

Amendment 84

Proposal for a regulation

Article 5 — paragraph 3 — point g e (new)

Text proposed by the Commission Amendment (ge) monitoring whether adequate risk assessments, preparedness plans and training courses are foreseen for health and social care professionals.

Amendment 85

Proposal for a regulation

Article 5 — paragraph 4

Text proposed by the Commission Amendment 4. The Union preparedness and response plan shall include interregional preparedness elements to establish coherent, multi-sectoral, cross-border public health measures, in particular considering capacities for testing, contact tracing, laboratories, and specialised treatment or intensive care across neighbouring regions. The plans shall include preparedness and response means to address the situation of those citizens with higher risks. 4. The Union prevention, preparedness and response plan shall include cross-border and interregional preparedness plans to establish coherent, multi-sectoral, cross-border public health measures, in particular considering capacities for testing, contact tracing, laboratories, training of healthcare staff and specialised treatment or intensive care across neighbouring regions. The plans shall include preparedness and response means to address the situation of those citizens with higher risks.

Amendment 86

Proposal for a regulation

Article 5 — paragraph 4 a (new)

Text proposed by the Commission Amendment 4a. The Union preparedness and response plan shall also provide for measures to ensure that the single market functions normally in the event serious cross-border threats to health arise.

Amendment 87

Proposal for a regulation

Article 5 — paragraph 5

Text proposed by the Commission Amendment 5. In order to ensure the operation of the Union preparedness and response plan, the Commission shall conduct stress tests, exercises and in-action and after-action reviews with Member States, and update the plan as necessary. 5. In order to ensure the operation of the Union prevention, preparedness and response plan, the Commission shall conduct stress tests, exercises and in-action and after-action reviews with Member States, and update the plan as necessary. The prevention, preparedness and response plan shall take into account health systems data and relevant data to be collected at national or regional level.

Amendment 88

Proposal for a regulation

Article 5 — paragraph 5 a (new)

Text proposed by the Commission Amendment 5a. In order to respond to public health emergencies, the European Commission may issue recommendations, based on Union health systems data, on the minimum resources needed, in relation, among other things, to each Member State’s population, for the provision of baseline universal health coverage of adequate quality, including on the option of pooling resources at Union level.

Amendment 89

Proposal for a regulation

Article 5 — paragraph 5 b (new)

Text proposed by the Commission Amendment 5b. The reviews and any subsequent adjustments to the plan shall be published to increase the transparency of the process of prevention, preparedness and response planning.

Amendment 90

Proposal for a regulation

Article 6 — title

Text proposed by the Commission Amendment National preparedness and response plans National prevention, preparedness and response plans

Amendment 91

Proposal for a regulation

Article 6 — paragraph 1

Text proposed by the Commission Amendment 1. When preparing national preparedness and response plans each Member State shall coordinate with the Commission in order to reach consistency with the Union preparedness and response plan, also inform without delay the Commission and the HSC of any substantial revision of the national plan. 1. When preparing national prevention, preparedness and response plans each Member State shall consult patients’ organisations, healthcare professionals’ organisations, industry and supply chain stakeholders, and national social partners, coordinate with the Commission in order to reach consistency with the Union prevention, preparedness and response plan, which shall be in accordance with arrangements for governance, capacities and resources referred to in Article 5(3), including with regard to national stockpiling requirements and the management of Union strategic reserves, and inform without delay the Commission and the HSC of any substantial revision of the national plan.

Amendment 92

Proposal for a regulation

Article 6 — paragraph 1 a (new)

Text proposed by the Commission Amendment 1a. National prevention, preparedness and response plans shall include arrangements for governance and information on capacities and resources referred to in Article 5(3).

Amendment 93

Proposal for a regulation

Article 7 — title

Text proposed by the Commission Amendment Reporting on preparedness and response planning Reporting on prevention, preparedness and response planning

Amendment 94

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 1

Text proposed by the Commission Amendment 1. Member States shall by the end of November 2021 and every 2 years thereafter provide the Commission with a report on their preparedness and response planning and implementation at national level . 1. Member States shall [within 6 months of the entry into force of this regulation] and every 2 years thereafter provide the Commission with an updated report on their prevention, preparedness and response planning and implementation at national and, where appropriate, regional and cross-border levels .

Amendment 95

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 2 — introductory part

Text proposed by the Commission Amendment That report shall cover the following: That report shall be succinct, based on common indicators, give an overview of the actions implemented in the Member States, and shall cover the following:

Amendment 96

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 2 — point a

Text proposed by the Commission Amendment (a) identification of, and update on the status of the implementation of the capacity standards for preparedness and response planning as determined at national level for the health sector, as provided to the WHO in accordance with the IHR; (a) identification of, and update on the status of the implementation of the capacity standards for prevention, preparedness and response planning as determined at national and, where appropriate, regional level for the health sector, as provided to the WHO in accordance with the IHR;

Amendment 97

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 2 — point a a (new)

Text proposed by the Commission Amendment (aa) a description of the measures or arrangements aimed at ensuring interoperability between the health sector and other sectors that are critical in the case of an emergency;

Amendment 98

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 2 — point a b (new)

Text proposed by the Commission Amendment (ab) a description of the business continuity plans, measures or arrangements aimed at ensuring the continuous delivery of critical services and products;

Amendment 99

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 2 — point b

Text proposed by the Commission Amendment (b) elements of emergency preparedness, in particular: (b) an update, if needed, on the elements of emergency prevention, preparedness and response , in particular:

Amendment 100

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 2 — point b — point i

Text proposed by the Commission Amendment (i) governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery coordination mechanisms; (i) governance: including national and, if appropriate, regional policies and legislation that integrate emergency prevention and preparedness; plans for emergency prevention, preparedness, response and recovery coordination mechanisms at national and, where relevant, regional and cross-border levels ; continuity of critical long-term healthcare;

Amendment 101

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 2 — point b — point ii

Text proposed by the Commission Amendment (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; access to diagnostic services during emergencies; basic and safe gender-sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness; (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; the capacities to produce medicinal products; stocks of medical countermeasures, including personal protective equipment of the highest quality; equitable access to diagnostic services and tools, and medical products during emergencies; information relevant for the internal market and Union strategic reserves of medical products; equitable, high-quality, basic and safe gender-sensitive health and emergency services that take account of the needs of populations at higher risk; continuity of screening, diagnosis, monitoring and treatment for care in relation to other diseases and conditions, in particular critical long-term healthcare ; risk communications; research development and evaluations to inform and accelerate emergency preparedness;

Amendment 102

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 2 — point b — point iii

Text proposed by the Commission Amendment (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and dedicated, trained and equipped human resources for emergencies; and (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; measures to ensure continuity of critical long-term healthcare; and health and social services with an adequate number of dedicated, trained and equipped human resources for emergencies;

Amendment 103

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 2 — point b — point iii a (new)

Text proposed by the Commission Amendment (iiia) strategic stockpile: each Member State shall provide information on the number and availability of medical countermeasures and other essential medicinal products and critical medical devices for the control of the threats set out in Article 2(1), as well as the capacity for their safekeeping and storage. In order to have a greater response capacity, storage shall be carried out in the premises closest to and most accessible for the population centres, without compromising the accessibility of those products for people in remote, rural and outermost regions, which meet the necessary requirements to provide the service in accordance with the regulations applicable to medicinal products, medical devices (1b) and other medical countermeasures; and

Amendment 104

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 2 — point c a (new)

Text proposed by the Commission Amendment (ca) the consultation with relevant partners that has taken place to ensure risk assessments, prevention, preparedness and response plans and implementation are broadly shared and supported and in line with applicable labour legislation and collective agreements;

Amendment 105

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 2 — point c b (new)

Text proposed by the Commission Amendment (cb) gaps found in the implementation and any necessary actions that will be taken by the Member States to improve their preparedness and response capacity.

Amendment 106

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 3

Text proposed by the Commission Amendment The report shall include , whenever relevant , interregional preparedness and response elements in line with the Union and national plans, covering in particular the existing capacities, resources and coordination mechanisms across neighbouring regions . For Member States sharing a land border with at least one other Member State, the report shall include cross-border , interregional and intersectoral prevention, preparedness and response plans with neighbouring regions including coordination mechanisms for all elements listed in points (a), (b) and (c), cross-border training and sharing of best practices for healthcare staff and public health staff and coordination mechanisms for the medical transfer of patients . Union or national entities that are engaged in stockpiling of medical products shall engage with the Commission and Member States in reporting of stocks that are available and taken into account in both Union and national preparedness and response planning.

Amendment 107

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 3 a (new)

Text proposed by the Commission Amendment The report shall also include, as far as feasible, information on the impact of communicable diseases on major non-communicable diseases.

Amendment 108

Proposal for a regulation

Article 7 — paragraph 1 — subparagraph 3 b (new)

Text proposed by the Commission Amendment The latest available version of the prevention, preparedness and response plans shall be attached to the report.

Amendment 109

Proposal for a regulation

Article 7 — paragraph 2 — subparagraph 4

Text proposed by the Commission Amendment The recommendations of the report shall be published on at the website of the Commission. The recommendations of the report shall be published on the websites of the Commission and the ECDC .

Amendment 110

Proposal for a regulation

Article 8 — title

Text proposed by the Commission Amendment Auditing on preparedness and response planning Auditing on prevention, preparedness and response planning

Amendment 111

Proposal for a regulation

Article 8 — paragraph 1

Text proposed by the Commission Amendment 1. Every 3 years, the ECDC shall conduct audits in the Member States aimed at ascertaining the state of implementation of the national plans and their coherence with the Union plan. Such audits shall be implemented with the relevant Union agencies, aiming at the assessment of preparedness and response planning at national level with regard to the information referred to in Article 7(1). 1. Every 2 years, the ECDC shall conduct audits in the Member States aimed at ascertaining the state of implementation of the national plans and their coherence with the Union plan. Such audits shall be based on a set of indicators and implemented in cooperation with the relevant Union agencies, aiming at the assessment of prevention, preparedness and response planning at national level with regard to the information referred to in Article 7(1)..

Amendment 112

Proposal for a regulation

Article 8 — paragraph 2 — introductory part

Text proposed by the Commission Amendment 2. Member States shall present an action plan addressing the proposed recommendations of the audit and the corresponding corrective actions and milestones. 2. In the event the audit identifies deficiencies, the Member State shall , within six months of receipt of its conclusions, present an action plan addressing the proposed recommendations of the audit and setting out the corresponding corrective actions and milestones.

Amendment 113

Proposal for a regulation

Article 8 — paragraph 2 — subparagraph 1 a (new)

Text proposed by the Commission Amendment If a Member State decides not to follow a recommendation, it shall state its reasons for doing so.

Amendment 114

Proposal for a regulation

Article 9 — title

Text proposed by the Commission Amendment Commission report on preparedness planning Commission report on prevention, preparedness planning

Amendment 115

Proposal for a regulation

Article 9 — paragraph 1

Text proposed by the Commission Amendment 1. On the basis of the information provided by the Member States in accordance with Article 7, and of the results of the audits referred to in Article 8, the Commission shall by July 2022 and every 2 years afterwards, transmit to the European Parliament and to the Council a report on the state of play and progress on preparedness and response planning at Union level. 1. On the basis of the information provided by the Member States in accordance with Article 7, and of the results of the audits referred to in Article 8, the Commission shall by July 2022 and every 2 years afterwards, transmit to the European Parliament and to the Council a report on the state of play and progress on prevention, preparedness and response planning at Union level.

Amendment 116

Proposal for a regulation

Article 9 — paragraph 1 a (new)

Text proposed by the Commission Amendment 1a. The Commission report shall include the state of cross-border preparedness and response planning in neighbouring regions.

Amendment 117

Proposal for a regulation

Article 9 — paragraph 2

Text proposed by the Commission Amendment 2. The Commission may adopt recommendations on preparedness and response planning addressed to Member States based on the report referred to in paragraph 1. 2. The Commission may adopt recommendations on prevention, preparedness and response planning addressed to Member States based on the report referred to in paragraph 1. Those recommendations may cover, inter alia, the minimum resources needed to respond to public health emergencies in relation to, among other things, population size, and they shall be developed on the basis of good practice and policy assessments.

Amendment 118

Proposal for a regulation

Article 10 — title

Text proposed by the Commission Amendment Coordination of preparedness and response planning in the HSC Coordination of prevention, preparedness and response planning in the HSC

Amendment 119

Proposal for a regulation

Article 10 — paragraph 1 — subparagraph 1

Text proposed by the Commission Amendment 1. The Commission and the Member States shall work together within the HSC to coordinate their efforts to develop, strengthen and maintain their capacities for the monitoring, early warning and assessment of, and response to serious cross-border threats to health. 1. The Commission , relevant Union agencies and the Member States shall work together within the HSC to coordinate their efforts to develop, strengthen and maintain their capacities for the monitoring, prevention, early warning and assessment of, and response to serious cross-border threats to health.

Amendment 120

Proposal for a regulation

Article 10 — paragraph 1 — subparagraph 2 — point a

Text proposed by the Commission Amendment (a) sharing best practice and experience in preparedness and response planning; (a) sharing best practice and experience in prevention, preparedness and response planning;

Amendment 121

Proposal for a regulation

Article 10 — paragraph 1 — subparagraph 2 — point b

Text proposed by the Commission Amendment (b) promoting the interoperability of national preparedness planning and the intersectoral dimension of preparedness and response planning at Union level; (b) promoting the interoperability of national prevention, preparedness planning and the intersectoral dimension of prevention, preparedness and response planning at Union level;

Amendment 122

Proposal for a regulation

Article 10 — paragraph 1 — subparagraph 2 — point e

Text proposed by the Commission Amendment (e) monitoring progress, identifying gaps and actions to strengthen preparedness and response planning, including in the field of research, at national and at Union levels. (e) monitoring progress, identifying gaps and actions to strengthen prevention, preparedness and response planning, including in the field of research, at regional, national and at Union levels;

Amendment 123

Proposal for a regulation

Article 10 — paragraph 1 a (new)

Text proposed by the Commission Amendment 1a. The Commission and the Member States shall, where appropriate, conduct a dialogue with stakeholders, including health and care workers’ organisations, industry and supply chain stakeholders, and patient and consumer organisations. That dialogue shall include regular exchanges of information between authorities, industry and relevant actors in the pharmaceutical supply chain to identify expected supply constraints so as to allow better coordination, development of synergies and appropriate responses.

Amendment 124

Proposal for a regulation

Article 11 — paragraph 1 — subparagraph 1

Text proposed by the Commission Amendment 1. The Commission may organise training activities for healthcare staff and public health staff in the Member States, including preparedness capacities under the International Health Regulations. 1. The Commission may organise training activities , supported by the relevant Union agencies, in close cooperation with medical associations and patient organisations, for healthcare staff, social service staff and public health staff in the Member States in particular interdisciplinary One Health training , including preparedness capacities under the International Health Regulations.

Amendment 125

Proposal for a regulation

Article 11 — paragraph 1 — subparagraph 2

Text proposed by the Commission Amendment The Commission shall organise those activities in cooperation with the Member States concerned. The Commission shall organise those activities in cooperation with the Member States concerned or potentially concerned, and in coordination, where possible, with the WHO to avoid duplication of activities, including preparedness capacities under the International Health Regulations .

Amendment 126

Proposal for a regulation

Article 11 — paragraph 1 — subparagraph 2 a (new)

Text proposed by the Commission Amendment In cross-border regions, joint cross-border training and sharing of best practices for healthcare staff and public health staff shall be promoted and familiarity with public health systems shall be mandatory.

Amendment 127

Proposal for a regulation

Article 11 — paragraph 1 — subparagraph 2 b (new)

Text proposed by the Commission Amendment The Commission shall use the fullest potential of distance learning to broaden the number of trainees.

Amendment 128

Proposal for a regulation

Article 11 — paragraph