2020/0322(COD) Serious cross-border threats to health
Next event: Approval in committee of the text agreed at 1st reading interinstitutional negotiations 2022/07/11 more...
Lead committee dossier:
Next event: Approval in committee of the text agreed at 1st reading interinstitutional negotiations 2022/07/11 more...
- Coreper letter confirming interinstitutional agreement 2022/06/29
- Decision by Parliament, 1st reading 2021/11/11
- Matter referred back to the committee responsible 2021/11/11
- Decision by Parliament, 1st reading 2021/09/14
- Debate in Parliament 2021/09/13
- Committee report tabled for plenary, 1st reading/single reading 2021/07/22
- Committee report tabled for plenary, 1st reading 2021/07/22
- Vote in committee, 1st reading 2021/07/13
- Committee opinion 2021/05/31
- Contribution 2021/05/18
Progress: Awaiting Parliament's position in 1st reading
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | ENVI |
TRILLET-LENOIR Véronique ( Renew)
|
DE LANGE Esther ( EPP),
CERDAS Sara ( S&D),
AUKEN Margrete ( Verts/ALE),
MÉLIN Joëlle ( ID),
KOPCIŃSKA Joanna ( ECR),
KONEČNÁ Kateřina ( GUE/NGL)
|
| Committee Opinion | IMCO |
ANDRESEN Rasmus ( Verts/ALE)
|
Adam BIELAN ( ECR),
Kateřina KONEČNÁ ( GUE/NGL),
Jordi CAÑAS ( RE),
Adriana MALDONADO LÓPEZ ( S&D),
Tomislav SOKOL ( PPE),
Jean-Lin LACAPELLE ( ID)
|
| Committee Opinion | BUDG |
Lead committee dossier:
Legal Basis:
TFEU 168-p5
Legal Basis:
TFEU 168-p5Events
2022/07/11
EP - Approval in committee of the text agreed at 1st reading interinstitutional negotiations
Documents
2022/06/29
CSL - Coreper letter confirming interinstitutional agreement
Documents
2021/11/11
EP - Decision by Parliament, 1st reading
Details
The European Parliament adopted amendments by the European Parliament to the proposal for a regulation of the European Parliament and of the Council on serious cross-border health threats and repealing Decision No 1082/2013/EU.
The matter was referred back to the committee responsible for inter-institutional negotiations. The main amendments adopted in plenary are the following:
Subject matter and scope
The proposal provides for a stronger and more comprehensive legal framework enabling the Union to react rapidly and to trigger preparedness and response measures to cross-border health threats throughout the EU.
As the health provisions of the Treaties remain largely underused, Members believe that the regulation should aim to make the best use of these provisions to demonstrate the strength of the EU's health policy.
Members proposed that the regulation should also establish rules on emergency research and innovation plans , including clinical trial networks and innovation platforms as well as a network of national strategic stockpiles and available medical countermeasures.
The Regulation should respect the 'One Health ' and 'Health in All Policies' approaches and ensure that in future health emergencies, the detection of, health interventions concerning and treatment of other serious diseases are not halted.
The strengthened EU health framework should work in synergy with other EU policies and funds. It should be implemented with full respect for the dignity and fundamental rights and freedoms of persons.
The Regulation should apply to the epidemiological surveillance of communicable diseases as well as to the surveillance of the impact of communicable diseases on major non-communicable diseases and on specific related health issues, such as mental health.
Members proposed that the EU call for the development of a WHO Framework Convention on Pandemic Preparedness and Response . This convention should facilitate the implementation of the International Health Regulations (2005) and address the shortcomings of these regulations identified during the COVID-19 crisis.
Coordination of preparedness and response planning in the Health Security Committee (HSC)
In liaison with the Commission and the relevant EU agencies , including the European Health Emergency Preparedness and Response Authority (HERA), the HSC should coordinate Member States' prevention, preparedness and response planning. It should adopt an annual action programme with clear priorities and objectives. Representatives of the relevant EU agencies, as well as a representative appointed by the European Parliament, should be able to participate in the HSC as observers.
Members of the Committee should have no financial or other interests that could affect their impartiality. The list of members of the HSC should be made public.
EU prevention, preparedness and response plan
This plan should be drawn up by the Commission, in cooperation with the Member States and the relevant EU agencies and taking into account the WHO framework. It should include:
- the risk and crisis communication, aimed at health professionals and at citizens;
- the mapping of the production capacities of medical products in the Union as a whole;
- the establishment of a Union stock of critical medicinal products , medical countermeasures and personal protective equipment as part of the rescEU emergency reserve;
- ensuring that healthcare services without disruption during health emergencies;
- the implementation of the provisions of the plan relating to emergency research and innovation aspects and ensuring that national health systems are inclusive and provide equal access to health and related services, and that quality treatments are available without delays;
- an adequate and needs-oriented staffing level;
- monitoring whether adequate risk assessments, preparedness plans and training courses are foreseen for health and social care professionals.
The EU plan should also include measures to ensure that the single market functions normally in the event serious cross-border threats to health arise.
National prevention, preparedness and response plans
Patients’ organisations, health professionals’ organisations, industry and supply chain stakeholders and national social partners should be consulted when drawing up national plans.
Member States should provide the Commission with an updated report on their national and, where appropriate, regional and cross-border prevention, preparedness and response planning and implementation within 6 months of the entry into force of the Regulation and every two years thereafter. The plan should include information on the ‘ strategic reserve ’, i.e. the number and availability of medical countermeasures and other essential medicinal products and critical medical devices for the control of the threats as well as the capacity for their safekeeping and storage.
Every two years, the ECDC should conduct audits in Member States to verify the state of implementation of national plans and their consistency with the EU plan. These audits would be based on a set of indicators and would be carried out in cooperation with the relevant EU agencies.
Joint procurement
Members also want the EU to be more transparent when awarding public contracts or concluding procurement contracts. The procurement process should require all parties to deliver and respect clear commitments, including that manufacturers deliver the agreed production quantities and that authorities buy the agreed set-aside volumes.
The precise quantities ordered by and provided to each participating country and the details of their liabilities should be made public. In the case of joint procurement, the award criteria should also take into account, for example, the manufacturer's ability to ensure security of supply during a health crisis.
The European Parliament should be informed of the negotiations and should reserve the right, at all times, to scrutinize, under existing confidentiality rules, the uncensored content of all contracts concluded in proceedings.
Early warning and response system
The ECDC should broaden its communication activities to European citizens by setting up a portal for sharing verified information. In addition, Members proposed to update the Early Warning and Response System (EWRS), an instrument managed by the ECDC, with modern technology to ensure its interoperability with international, European, national and regional alert systems.
Documents
2021/11/11
EP - Matter referred back to the committee responsible
2021/09/14
EP - Decision by Parliament, 1st reading
Details
The European Parliament adopted by 594 votes to 85, with 16 abstentions, amendments to the proposal for a regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU.
The matter was referred back to the committee responsible for interinstitutional negotiations.
The main amendments adopted in plenary concern the following points:
Purpose and scope
The proposal provides for a stronger and more comprehensive legal framework enabling the EU to react rapidly and to trigger preparedness and response measures to cross-border health threats throughout the EU.
According to Members, the COVID-19 crisis has shown that more action is needed at EU level to support cooperation between Member States, in particular between border regions. The regulation should respect the 'One Health' and 'Health in All Policies' approaches and ensure that in future health emergencies, the detection of, health interventions and treatment of other serious diseases, are not halted.
The regulation should apply to threats of biological origin including communicable diseases, including those of zoonotic origin, and to epidemiological surveillance of communicable diseases and monitoring of the impact of these diseases on major non-communicable diseases and health problems such as mental health.
Members proposed that the EU call for the development of a WHO Framework Convention on Pandemic Preparedness and Response . This convention should facilitate the implementation of the International Health Regulations (2005) and address the shortcomings of these regulations identified during the COVID-19 crisis.
Coordination of preparedness and response planning in the Health Security Committee (HSC)
Representatives of relevant EU agencies, including the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA), should participate in HSC meetings as observers. The European Parliament should nominate representatives to participate in the HSC as observers. In liaison with the Commission and the relevant EU agencies, the HSC should coordinate Member States' prevention, preparedness and response planning.
EU prevention, preparedness and response plan
This plan should be drawn up by the Commission, in cooperation with the Member States and the relevant EU agencies and taking into account the WHO framework. It should include:
- the mapping of the production capacities of medical products in the Union as a whole;
- the establishment of a Union stock of critical medicinal products, medical countermeasures and personal protective equipment as part of the rescEU emergency reserve;
- ensuring that healthcare services, including the screening, diagnosis, monitoring, treatment and care for other diseases and conditions, are provided without disruption during health emergencies;
- ensuring that national health systems are inclusive and provide equal access to health and related services, and that quality treatments are available without delays;
- monitoring whether adequate risk assessments, preparedness plans and training courses are foreseen for health and social care professionals.
The EU plan should also include measures to ensure that the EU preparedness and response plan should also provide for measures to ensure that the single market functions normally in the event serious cross-border threats to health arise.
National prevention, preparedness and response plans
Members proposed that each Member State should consult patients’ organisations, health professionals’ organisations, industry and supply chain stakeholders and national social partners when drawing up national plans.
Member States should provide the Commission with an updated report on their national and, where appropriate, regional and cross-border prevention, preparedness and response planning and implementation within 6 months of the entry into force of the Regulation and every two years thereafter. Every two years, the ECDC should carry out audits in Member States to verify the state of implementation of national plans and their consistency with the EU plan. These audits would be based on a set of indicators and would be carried out in cooperation with the relevant EU agencies.
Joint procurement
Members also want the EU to be more transparent when awarding contracts or making purchases. The precise quantities ordered by and supplied to each participating country and the details of their commitments should be made public.
The joint procurement process should be conducted in such a way as to strengthen the purchasing power of participating countries, improve security of supply and ensure equitable access to medical countermeasures in the event of serious cross-border health threats. If joint procurement is deployed, qualitative criteria should be considered in the award process, in addition to cost. Such criteria should also take into consideration, for example, the ability of the manufacturer to ensure security of supply during a health crisis.
The European Parliament reserves at all times the right to scrutinize, under existing confidentiality rules, the uncensored content of all contracts concluded in proceedings referred to in this Regulation.
Early warning and response system
The ECDC should broaden its communication activities to European citizens by setting up a portal for sharing verified information. In addition, Members proposed to update the Early Warning and Response System (EWRS), an instrument managed by the ECDC, with modern technology to ensure its interoperability with international, European, national and regional alert systems.
Documents
2021/09/13
EP - Debate in Parliament
Documents
2021/07/22
EP - Committee report tabled for plenary, 1st reading/single reading
Documents
2021/07/22
EP - Committee report tabled for plenary, 1st reading
Documents
2021/07/13
EP - Vote in committee, 1st reading
2021/05/31
EP - Committee opinion
Documents
2021/05/18
IT_SENATE - Contribution
Documents
2021/05/07
CofR - Committee of the Regions: opinion
Documents
2021/04/29
EP - Amendments tabled in committee
Documents
2021/04/29
EP - Amendments tabled in committee
Documents
2021/03/23
EP - Committee draft report
Documents
2021/03/23
CZ_SENATE - Contribution
Documents
2021/02/24
PT_PARLIAMENT - Contribution
Documents
2021/02/21
ES_PARLIAMENT - Contribution
Documents
2021/01/26
EP - ANDRESEN Rasmus (Verts/ALE) appointed as rapporteur in IMCO
2020/12/14
EP - Committee referral announced in Parliament, 1st reading
2020/11/26
EP - TRILLET-LENOIR Véronique (Renew) appointed as rapporteur in ENVI
2020/11/11
EC - Legislative proposal published
Details
PURPOSE: to strengthen the EU health security framework addressing cross-border health threats.
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: the current health security framework, established by Decision 1082/2013/EU on serious cross-border threats to health, provides a limited legal framework for EU level coordination, based essentially on a) an early warning system (EWRS) and the exchange of information and cooperation within the HSC. Early lessons learnt have shown that the current system has not allowed an optimal response at EU level to the COVID-19 pandemic.
Structures and mechanisms under the Decision, while key in facilitating the exchange of information on the evolution of the pandemic and in supporting the adoption of national measures, could do little to trigger a timely common EU level response, co-ordinate the crucial aspects of risk communication, or ensure solidarity among Member States.
The revision of the health security framework proposes a stronger and more comprehensive legal basis for the EU to prepare and respond to health crises. In addition, the proposal is part of a package of closely associated measures that aim to enhance the roles of the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA).
CONTENT: the overarching aim of the proposed regulation is to provide a strengthened framework for health crisis preparedness and response at EU level by addressing the weaknesses exposed by the COVID-19
pandemic. In particular, it would:
set out a comprehensive legislative framework to govern action at EU level on preparedness, surveillance, risk assessment, and early warning and responses; and enhance the EU’s guidance in the adoption of common measures at EU level to face a future cross-border health threat.
The proposal aims to provide EU added value through the development of an EU health crisis and pandemic preparedness plan, complemented by:
national plans and transparent reporting of capacities; strengthened, integrated surveillance systems at EU level supported by improved data collection tools and artificial intelligence, environmental surveillance, to detect early signals of a possible threat; enhanced risk assessment for health threats; increased power to enforce a coordinated response at EU level through the Health Security Committee; and an improved mechanism for recognition of and response to public health emergencies.
Budgetary implications
The financial impact of this proposal on the EU budget should be part of the next Multiannual Financial Framework 2021-2027. The budgetary implications are related mainly to the following objectives:
preparedness plans established at EU and national level accompanied by reporting and auditing; training programmes for specialists; digitalised, integrated surveillance system at EU level, better detection of early signals for accurate risk assessment and response; establishment of new EU networks of laboratories; reinforcement of risk assessments for chemical, environmental and climate threats; and established structure and processes for the recognition of emergency at EU level.
Documents
Documents
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: GEDA/A/(2022)004942
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2022)004942
- Decision by Parliament, 1st reading: T9-0449/2021
- Decision by Parliament, 1st reading: T9-0377/2021
- Debate in Parliament: Debate in Parliament
- Committee report tabled for plenary, 1st reading/single reading: A9-0247/2021
- Committee report tabled for plenary, 1st reading: A9-0247/2021
- Committee opinion: PE689.513
- Contribution: COM(2020)0727
- Committee of the Regions: opinion: CDR5624/2020
- Amendments tabled in committee: PE692.634
- Amendments tabled in committee: PE692.635
- Committee draft report: PE689.812
- Contribution: COM(2020)0727
- Contribution: COM(2020)0727
- Contribution: COM(2020)0727
- Legislative proposal published: COM(2020)0727
- Legislative proposal published: EUR-Lex
- Committee draft report: PE689.812
- Amendments tabled in committee: PE692.634
- Amendments tabled in committee: PE692.635
- Committee of the Regions: opinion: CDR5624/2020
- Committee opinion: PE689.513
- Committee report tabled for plenary, 1st reading/single reading: A9-0247/2021
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2022)004942
- Contribution: COM(2020)0727
- Contribution: COM(2020)0727
- Contribution: COM(2020)0727
- Contribution: COM(2020)0727
Activities
- Margrete AUKEN
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- Adam BIELAN
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- Lefteris CHRISTOFOROU
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- Angel DZHAMBAZKI
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- Laura FERRARA
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- José Manuel FERNANDES
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- Jytte GUTELAND
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- Othmar KARAS
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- Seán KELLY
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- Kateřina KONEČNÁ
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- Esther DE LANGE
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- Peter LIESE
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- Tilly METZ
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- Joëlle MÉLIN
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- Alessandra MORETTI
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| Amendments | Dossier |
| 706 |
2020/0322(COD)
2021/04/21
IMCO
165 amendments...
Amendment 10 #
Proposal for a regulation Recital 2 (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 health and zoonotic 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 or animal origin. The capacity for contact tracing should be strengthened via the creation of an automated system, using modern technologies.
Amendment 100 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point ii (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information
Amendment 101 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point iii (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and adequate needs-oriented number of dedicated, trained and equipped human resources for emergencies in the health and social services; and
Amendment 102 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point iii (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms, means of national production and essential supplies for health; and dedicated, trained and equipped human resources for emergencies; and
Amendment 103 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point c a (new) (ca) the consultation with social partners that has taken place to ensure risk assessments, preparedness plans and implementation are broadly shared and supported and in line with prevailing labour legislation and collective agreements;
Amendment 104 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 2 Based on the report, the Commission shall, in a timely manner, initiate discussion in the HSC to discuss progress and gaps in preparedness and propose specific measures and actions to close existing gaps and prepare more effectively for future developments.
Amendment 105 #
Proposal for a regulation Article 8 – paragraph 2 Amendment 106 #
Proposal for a regulation Article 8 – paragraph 2 – subparagraph 1 – point b (b) initiatives in relation to recruitment and retention of healthcare personnel and training initiatives;
Amendment 107 #
Proposal for a regulation Article 10 – paragraph 1 – introductory part 1. The Commission and the Member States
Amendment 108 #
Proposal for a regulation Article 11 – paragraph 1 – introductory part 1. The Commission may organise training activities for healthcare and social service staff and public health staff in the Member States, including preparedness capacities under the International Health Regulations.
Amendment 109 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 The Commission shall organise those activities in cooperation with the Member States concerned. The Commission will consult the relevant European social partners for the health and social care sector on the training activities.
Amendment 11 #
Proposal for a regulation Recital 2 (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 a promptly coordinated and 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.
Amendment 110 #
Proposal for a regulation Article 12 – paragraph 1 1. The Commission and any Member States which so desire may engage in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council29 with a view to the advance purchase of medical countermeasures for the purpose of preparedness and response to serious cross-border threats to health only. __________________ 29Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
Amendment 111 #
Proposal for a regulation Article 12 – paragraph 1 1.
Amendment 112 #
Proposal for a regulation Article 12 – paragraph 1 1. The Commission and any Member States which so desire may engage in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health. In this context, the Commission shall make use of the services of negotiators who can demonstrate practical expertise in contract logistics and public procurement, both public and private, in similar volumes and conditions. These negotiators shall be approved by the representatives of the participating Member States. __________________ 29Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
Amendment 113 #
Proposal for a regulation Article 12 – paragraph 2 – point -a (new) (-a) the joint procurement shall be time-limited to the existence of a serious cross-border threat to health and be used for the purchase and supply of each medical countermeasure to the most recommendable needs, as long as it cannot be ensured as efficiently by other means;
Amendment 114 #
Proposal for a regulation Article 12 – paragraph 2 – point -a a (new) (-aa) the commitments and contractual obligations defined by the corresponding purchase agreement shall be respected by all parties involved;
Amendment 115 #
Proposal for a regulation Article 12 – paragraph 2 – point -a b (new) (-ab) a priority conditionality binding the undertaking of the joint procurement procedures should be provided for, in order to ensure that the delivery and scheduled commitments to the participating countries are respected;
Amendment 116 #
Proposal for a regulation Article 12 – paragraph 2 – point a (a) participation in the joint procurement procedure is
Amendment 117 #
Proposal for a regulation Article 12 – paragraph 2 – point a a (new) (aa) the purpose of joint procurement should be to guarantee stability in an unpredictable environment during a serious cross-border threat to health only. In other circumstances, other measures shall be privileged, such as procurement at national level;
Amendment 118 #
Proposal for a regulation Article 12 – paragraph 2 – point b (b) the rights and obligations of Member
Amendment 119 #
Proposal for a regulation Article 12 – paragraph 2 – point b a (new) (ba) the joint procurement shall be carried in a transparent, timely and effective way defining clear steps since the beginning of the procedure in terms of process, scope, tender specifications, timeline sand formalities. A preliminary consultation phase involving participating actors shall be guaranteed, as well as a two-way communication throughout the whole procedure;
Amendment 12 #
Proposal for a regulation Recital 2 (2) In light of the lessons learnt during the ongoing COVID-19 pandemic and in order to facilitate adequate Union-wide
Amendment 120 #
Proposal for a regulation Article 12 – paragraph 2 – point c (c) Member States, EFTA States and Union candidate countries participating in a joint procurement shall procure the medical countermeasure in question only through that procedure and not through other channels, and shall not run parallel negotiation processes for that product; running parallel negotiation processes shall lead to an exclusion from the group of participating countries.
Amendment 121 #
Proposal for a regulation Article 12 – paragraph 2 – point c (c) Member States
Amendment 122 #
Proposal for a regulation Article 12 – paragraph 2 – point c (c) Member States, EFTA States and Union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels, and shall not run parallel negotiation processes for that product; running parallel negotiation processes shall lead to being excluded from the group of participating countries, without prejudice to participating countries from honouring existing contractual agreements, nor existing procurement procedures implemented by participating countries;
Amendment 123 #
Proposal for a regulation Article 12 – paragraph 2 – point c (c) Member States, EFTA States and Union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels, and shall not run parallel negotiation processes for that product. In addition, joint procurement shall not exempt participating countries from honouring existing contractual agreements nor shall replace countries regular procurement processes;
Amendment 124 #
Proposal for a regulation Article 12 – paragraph 2 – point c a (new) (ca) the joint procurement shall be conducted in such a way so as to improve the security and capacity of supply of medical countermeasures against serious cross-border threats to health in the participating countries, ensure equitable access to the largest extent possible, and strengthen the purchasing power of participating countries;
Amendment 125 #
Proposal for a regulation Article 12 – paragraph 2 – point c a (new) (ca) the joint procurement shall be conducted in such a way so as to strengthen the purchasing power of participating countries, improve the security of supply and ensure fair, equitable and affordable, access to medical countermeasures against serious cross-border threats to health;
Amendment 126 #
Proposal for a regulation Article 12 – paragraph 2 – point c a (new) (ca) the joint procurement lead times shall be aligned with manufacturers lead times;
Amendment 127 #
Proposal for a regulation Article 12 – paragraph 2 – point c b (new) (cb) commitments should be defined and respected by all parties involved from manufacturers, supply chain stakeholders and authorities;
Amendment 128 #
Proposal for a regulation Article 12 – paragraph 2 – point d (d) the joint procurement shall not affect the internal market, shall not constitute discrimination or a restriction of trade and shall not cause distortion of competition. It shall enable, among other things, the negotiation and procurement by Member States of medical countermeasures from suppliers other than the specific supplier chosen for the joint procedure in which they are participants;
Amendment 129 #
Proposal for a regulation Article 12 – paragraph 2 – point d (d) the joint procurement shall not affect the internal market, shall not constitute discrimination or a restriction of trade and shall not cause distortion of competition or concentration of demand; the joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU;
Amendment 13 #
Proposal for a regulation Recital 2 (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
Amendment 130 #
Proposal for a regulation Article 12 – paragraph 2 – point d (d) the joint procurement shall not affect the internal market, shall not constitute discrimination or a restriction of trade and shall not cause distortion of competition, nor replace existing procurement procedures implemented by participating countries;
Amendment 131 #
Proposal for a regulation Article 12 – paragraph 2 – point d a (new) (da) the joint procurement shall be carried in a transparent, timely and effective way defining clear steps since the start of the procedure in terms of process, scope, tender specifications, timelines and formalities;
Amendment 132 #
Proposal for a regulation Article 12 – paragraph 2 – point d a (new) (da) qualitative criteria beyond the lowest price shall be defined and be considered in the awarding process of the joint procurement bids;
Amendment 133 #
Proposal for a regulation Article 12 – paragraph 2 – point d b (new) (db) the joint procurement lead times shall be aligned with manufacturers lead times;
Amendment 134 #
Proposal for a regulation Article 12 – paragraph 2 – point d c (new) (dc) a preliminary consultation phase involving participating actors shall be guaranteed, as well as a clear mutual communication throughout the whole procedure;
Amendment 135 #
Proposal for a regulation Article 12 – paragraph 2 – point d d (new) (dd) Member States’ authorities shall apply regulatory flexibilities, where relevant and with due regard to EMA’s guidance, to ensure the timely supply of medical countermeasures through joint procurement procedures during the existence of a cross-border health threat;
Amendment 136 #
Proposal for a regulation Article 12 – paragraph 2 – point e (e) the joint procurement shall not have any direct financial impact on the budget of Member States
Amendment 137 #
Proposal for a regulation Article 12 – paragraph 2 – point e a (new) (ea) the joint procurement shall be subject to high transparency standards, provided it does not jeopardize the negotiation and compliance of purchase agreements, including in relation to the disclosure of the exact amount provided to each participating country, details regarding supply chains, production and delivery of procured medical countermeasures, and details of the liability of participating countries, as well as information on the existence of no- fault compensation systems in those participating countries.
Amendment 138 #
Proposal for a regulation Article 12 – paragraph 2 – point e a (new) (ea) a Member State engaging in a joint procurement may make a change to the request set out earlier, including resignation from participation in the procurement, if there has been a significant change in the circumstances arising from a well-founded public interest.
Amendment 139 #
Proposal for a regulation Article 12 – paragraph 2 a (new) 2a. Joint public procurement procedures shall include accessible, transparent, qualitative and non- discriminatory technical specifications and selection criteria, which shall be considered in the awarding process of the joint procurement bids and comply with the following conditions and order of priority: 1. They shall rely on the verification and compliance of the medical countermeasure forming the subject of the joint procurement procedure in question, with the highest safety and quality standards, as required by the relevant legislation; 2. They shall evaluate the ability of the bidder to ensure the security and capacity of supply of the medical countermeasure in question in a cross- border health threat situation; 3. They shall provide for sufficient and adequate flexibility of technical and economic solvency requirements, and lots shall accordingly be adjusted to those in the corresponding tender documents, thereby allowing the involvement and participation of small and medium-sized enterprises in joint procurement procedures and a wider selection of successful suppliers in the awarding process. 4. They shall evaluate lastly the price and costs of the medical countermeasure in question.
Amendment 14 #
Proposal for a regulation Recital 5 (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
Amendment 140 #
Proposal for a regulation Article 12 – paragraph 3 – introductory part Amendment 141 #
Proposal for a regulation Article 12 – paragraph 3 – introductory part 3. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the entities organizing and participating in any action, including, but not limited to joint procurement procedures, stockpiling and donation of medical countermeasures under different mechanisms established at Union level, in particular under:
Amendment 142 #
Proposal for a regulation Article 12 – paragraph 3 a (new) 3a. Participating Member states shall ensure an adequate stockpiling and distribution of procured medical countermeasures, whose main details and characteristics shall be set out in national plans. In addition, national plans shall address potential bottlenecks and capacity obstacles that may jeopardise the delivery of medical countermeasures acquired through joint procurement mechanisms to their final destination.
Amendment 143 #
Proposal for a regulation Article 12 – paragraph 3 a (new) 3a. Member States’ ability to hold strategic reserves shall be guaranteed, as well as their capacity to direct the use of these reserves solely for the benefit of their nationals and nationals of other Member States residing on their territory. Member States shall remain free to decide whether or not to share the use of these reserves.
Amendment 144 #
Proposal for a regulation Article 12 – paragraph 3 a (new) 3a. In case the joint procurement procedure for medical countermeasures is not applied, the European Commission as well as the Member States shall guarantee transparency of net pricing, delivery dates and reimbursement, to allow Member States equal conditions when negotiating with pharmaceutical companies.
Amendment 145 #
Proposal for a regulation Article 12 – paragraph 3 a (new) 3a. In accordance with the principle of transparency, the Commission shall regularly inform the European Parliament on the negotiations and other details of the joint procurement of medical countermeasures.
Amendment 146 #
Proposal for a regulation Article 12 – paragraph 3 b (new) 3b. Member States shall establish no- fault compensation systems which shall be used in the event of a cross-border health threat declared by the EU, allowing citizens who may suffer an adverse reaction to a particular medical countermeasure subject to a joint procurement procedure, to receive fair compensation by proving solely the causal link between the medical countermeasure in question and the damages caused.
Amendment 147 #
Proposal for a regulation Article 12 – paragraph 3 b (new) 3b. The European Parliament reserves at all times the right to inspect the uncensored content of all contracts concluded in proceedings under this Article.
Amendment 148 #
Proposal for a regulation Article 12 – paragraph 3 c (new) 3c. The Commission and Member states shall provide up-to-date, accessible and clear information to consumers on their rights and duties regarding jointly procured medical countermeasures, including details on liability for damages, access to legal protection and access to consumer representation.
Amendment 149 #
Proposal for a regulation Article 13 – paragraph 1 1. The network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1) shall ensure a permanent communication between the Commission, the ECDC, and the competent authorities responsible at national, and where applicable regional, level for epidemiological surveillance.
Amendment 15 #
Proposal for a regulation Recital 5 (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 or animal origin (blood, tissues and cells, organs), and exposure to ionising radiation.
Amendment 150 #
Proposal for a regulation Article 13 – paragraph 2 – point c (c) contribute to the evaluation and monitoring of communicable disease prevention and control programmes in order to provide the evidence for recommendations to strengthen and improve those programmes at the regional, national and Union level;
Amendment 151 #
Proposal for a regulation Article 13 – paragraph 2 – point i a (new) (ia) make mitigation plans containing preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains, as well as including production and supply capacity;
Amendment 152 #
Proposal for a regulation Article 13 – paragraph 3 – introductory part 3. The national and regional competent authorities referred to in paragraph 1 shall communicate the following information to the participating authorities of the epidemiological surveillance network:
Amendment 153 #
Proposal for a regulation Article 13 – paragraph 3 – point f (f) information about contract tracing monitoring systems developed at national and regional level.
Amendment 154 #
Proposal for a regulation Article 13 – paragraph 4 4. When reporting information on epidemiological surveillance, the national and regional competent authorities shall, where available, use the case definitions adopted in accordance with paragraph 9 for each communicable disease and related special health issue referred to in paragraph 1.
Amendment 155 #
Proposal for a regulation Article 13 – paragraph 10 10. On 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 among the Member States, the Commission may
Amendment 156 #
Proposal for a regulation Article 14 – paragraph 1 1. The ECDC shall ensure the further development of the digital platform through which data are managed and automatically exchanged, to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, for the purpose of supporting communicable disease prevention and control. The platform should be used with the human in control principle on the artificial intelligence.
Amendment 157 #
Proposal for a regulation Article 14 – paragraph 2 – point a (a) enable the automated collection of surveillance and laboratory data, make use of information from electronic health records, with the consent of the patients concerned and in strict compliance with personal data protection rules, as well as media monitoring, media monitoring, and apply artificial intelligence for data validation, analysis and automated reporting;
Amendment 158 #
Proposal for a regulation Article 14 – paragraph 2 – point b (b) allow for the computerised
Amendment 159 #
Proposal for a regulation Article 14 – paragraph 3 3. Member States are responsible for ensuring that the integrated surveillance system is fed on a regular basis with timely
Amendment 16 #
Proposal for a regulation Recital 6 (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,, as well as in close dialogue with 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. 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 160 #
Proposal for a regulation Article 14 – paragraph 6 – point d Amendment 161 #
Proposal for a regulation Article 16 – paragraph 1 1. A network of Member States’ services
Amendment 162 #
Proposal for a regulation Article 18 – paragraph 1 1. The EWRS shall enable the Commission and the competent authorities responsible at national level to be in permanent communication for the purposes of preparedness, early warning and response, alerting, assessing public health risks and
Amendment 163 #
Proposal for a regulation Article 21 – paragraph 1 – introductory part 1. Following an alert notification pursuant to Article 19, on a request from
Amendment 164 #
Proposal for a regulation Article 21 – paragraph 1 – point b (b) risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing
Amendment 165 #
Proposal for a regulation Article 22 – paragraph 2 – point c a (new) (ca) take into account the need for the normal functioning of the single market, in particular the existence of green lines for free circulation of food and other medical countermeasures.
Amendment 166 #
Proposal for a regulation Article 25 – paragraph 1 – point c (c) activation of support from the ECDC as referred to in Regulation (EU) …/… [OJ: Please insert the number of Regulation ECDC [ISC/2020/12527]] to mobilise and deploy the EU Health Task Force
Amendment 167 #
Proposal for a regulation Article 25 – paragraph 1 – point c a (new) (ca) green lines under Article 25a of this Regulation.
Amendment 168 #
Proposal for a regulation Article 25 – paragraph 1 a (new) 1a. It shall have no effect on the activation and functioning of health emergency arrangements under Member States’ legislation, where they exist.
Amendment 169 #
Proposal for a regulation Article 25 a (new) Article 25a Free movement of goods and services 1. After recognising a public health emergency under Article 23 of this Regulation, green lines shall be set up to allow the free movement of food and medical countermeasures within the internal market. The Commission is empowered to adopt delegated acts to supplement this Regulation with provisions on the establishment of the green lines referred to in the first subparagraph of paragraph 1. 2. Only on condition that the Commission grants prior authorisation Member States may, in accordance with Article 36 of TFEU, impose export restrictions on medical countermeasures concerning another Member State or Member States during a public health emergency at Union level. Upon receiving a request for prior authorisation referred to in the first subparagraph of paragraph 2 from a Member State, the Commission shall decide whether to grant it without delay. If within five days the Commission has not granted the prior authorisation in question, it shall be deemed granted.
Amendment 17 #
Proposal for a regulation Recital 6 (6) The protection of human health is a matter which has a cross-cutting dimension
Amendment 170 #
Proposal for a regulation Article 29 – paragraph 1 By 2025 and every 5 years thereafter the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council. The evaluation shall be conducted in accordance with the Commission’s better regulation guidelines. The evaluation shall include, in particular,
Amendment 171 #
Proposal for a regulation Article 29 – paragraph 1 By 2025 and every 5 years thereafter the Commission shall carry out an evaluation of this Regulation and present a report on the main findings to the European Parliament and the Council. The evaluation shall be conducted in accordance with the Commission’s better regulation guidelines. The evaluation shall include, in particular, an assessment of the operation of the EWRS and the epidemiological surveillance network, as well as the coordination of the response with the HSC and the impact of the Regulation on the proper functioning of the single market during serious cross-border threats to health.
Amendment 18 #
Proposal for a regulation Recital 7 (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
Amendment 19 #
Proposal for a regulation Recital 7 (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 interdisciplinary 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.
Amendment 20 #
Proposal for a regulation Recital 8 (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
Amendment 21 #
Proposal for a regulation Recital 8 (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
Amendment 22 #
Proposal for a regulation Recital 8 (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
Amendment 23 #
Proposal for a regulation Recital 8 a (new) (8a) In light of the lessons learnt during the ongoing COVID-19 pandemic, this Regulation should create a more robust framework for coordination at Union level. The shift for procurement of PPE, medical equipment and vaccines (under rescEU, the Joint Procurement Agreement (JPA) and the EU Emergency Support Initiative (ESI)) from national to European level has been effective and beneficial to citizens. It avoids competition between Member States and guarantees a secure, fair, equitable and affordable access to medical countermeasures. Therefore, joint procurement procedures should be applied by default for medical countermeasures to cross border threats to health.
Amendment 24 #
Proposal for a regulation Recital 8 a (new) (8a) This regulation should draw on lessons learned from the COVID-19 pandemic to assess whether an EU coordination mandate is needed, particularly in view of the difficulties encountered in the European Commission’s negotiation of contracts for centralised procurement of vaccines as when as during their delivery. Such lessons should lead to the incorporation into negotiating mandates of provisions on negotiators’ qualifications, terms and conditions and deadlines for delivery, as well as the benefits or sanctions applicable in the event of diligence or default.
Amendment 25 #
Proposal for a regulation Recital 8 a (new) (8a) Building on lessons learnt from the COVID-19 pandemic, this Regulation should create a more robust mandate for coordination at Union level. The declaration by the WHO of a public health emergency, formally recognised at Union level, would bring about increased coordination and exceptionally allow for joint procurement procedures for the development, stockpiling, distribution and donation of medical countermeasures, to the most recommendable needs and where their purchase and supply cannot be ensured as efficiently by other means.
Amendment 26 #
Proposal for a regulation Recital 8 b (new) (8b) The primary purpose of joint procurement should be to improve the preparedness and response to serious cross-border threats to health, and particularly to improve the security and capacity of supply of medical countermeasures in the participating countries throughout their existence, ensure equitable access to patients and provide increased visibility and predictability for actors involved.
Amendment 27 #
Proposal for a regulation Recital 8 b (new) (8b) To ensure resilience of the single market during future health emergency situations and in order to reduce the dependence on third countries, this Regulation should foster the creation of minimum European stocks of medical countermeasures as strategic products.
Amendment 28 #
Proposal for a regulation Recital 9 (9) As serious cross-border threats to health are not limited to Union borders, joint procurement of medical
Amendment 29 #
Proposal for a regulation Recital 9 (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
Amendment 30 #
Proposal for a regulation Recital 9 (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 and for security and capacity of supply of the medical countermeasure in question. 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
Amendment 31 #
Proposal for a regulation Recital 9 (9)
Amendment 32 #
Proposal for a regulation Recital 9 (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 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
Amendment 33 #
Proposal for a regulation Recital 9 (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
Amendment 34 #
Proposal for a regulation Recital 9 a (new) (9a) The Joint procurement should be carried in a transparent, timely and effective way to prevent market disruption and to ensure actors involved fulfil their contractual responsibilities. In this respect, it is crucial to define clear and transparent steps since the beginning of the procedure in terms of process, scope, tender specifications, timelines and formalities. A preliminary consultation phase involving participating actors should be guaranteed, as well as a clear and mutual communication throughout the whole procedure.
Amendment 35 #
Proposal for a regulation Recital 9 a (new) (9a) As the purpose of joint procurement was to ensure the swift provision of medical countermeasures to EU Member States in a highly competitive market, participation in this mechanism should be restricted to EU Member States only, as otherwise demand would outstrip supply and place too great a strain on suppliers’ capacity to cover orders.
Amendment 36 #
Proposal for a regulation Recital 9 a (new) (9a) The joint procurement procedure should first and foremost foster cooperation and solidarity between the Member States during a serious health crisis, strengthen their negotiating position and allow for a preferable purchasing conditions, concerning the quantity, price or availability of a procured medical countermeasure.
Amendment 37 #
Proposal for a regulation Recital 9 a (new) (9a) In order to achieve transparency, the Commission shall provide to the European Parliament complete, timely and accurate information on the ongoing negotiations and give an access to the tender documents for the purposes of carrying out the procedure referred to in Article 12 of this Regulation.
Amendment 38 #
Proposal for a regulation Recital 9 a (new) (9a) The primary purpose of joint procurement should be to guarantee stability in an unpredictable environment in the context of a cross-border health crisis only, ensuring equitable access for patients and increased visibility and predictability for actors involved.
Amendment 39 #
Proposal for a regulation Recital 9 a (new) (9a) In order to ensure a fair and equal procedure and access for all European citizens, the European Parliament shall scrutinize contracts concluded under the Joint Procurement Procedure.
Amendment 40 #
Proposal for a regulation Recital 9 b (new) (9b) Since one of the primary responsibility of the Member States is to ensure the protection of their citizens, additional flexibility is needed when it comes to being able to adjust contractual provisions after the initial contract has been established, in order to increase, decrease or cancel the order for the medical countermeasures. In order to protect the contractors, directly engaged in activities that serve Union policies, such contractual adjustments should be duly justified by the national authorities participating in the joint procurement procedure, by explaining the seriousness or urgency of the circumstances in question and such adjustments should be enforced in close cooperation with contracted partners and taking due account of the commitments made up to date of contractual adjustment.
Amendment 41 #
Proposal for a regulation Recital 9 b (new) (9b) The functioning of the Joint Procurement Agreement and rescEU should abide by high standards of transparency, provided it does not jeopardize the negotiation and compliance of purchase agreements, including in relation to the disclosure of the exact amount provided to each participating country, details regarding supply chains, production and delivery of procured products, and details of the liability of participating countries, as well as information on the existence of no-fault compensation systems in those participating countries.
Amendment 42 #
Proposal for a regulation Recital 9 b (new) (9b) The Joint procurement shall be carried in a transparent, timely and effective way to prevent market disruption and to ensure actors involved can fulfil their contractual responsibilities. In this respect, it is crucial to define clear and transparent steps since the beginning of the procedure in terms of process, scope, tender specifications, timelines and formalities. A preliminary consultation phase involving participating actors shall be guaranteed, as well as a two-way communication throughout the whole procedure.
Amendment 43 #
Proposal for a regulation Recital 9 b (new) (9b) For the same reason, the joint ordering of medical countermeasures by the European Union should be reserved for the priority use of the Member States participating in this mechanism, in preference over those not taking part, and should rule out any redistribution outside the European Union.
Amendment 44 #
Proposal for a regulation Recital 9 c (new) (9c) The COVID-19 pandemic has exposed the limited diversity of suppliers and an over-reliance on particular supply chains. Such vulnerabilities need to be addressed by encouraging broader participation of small and medium-sized enterprises (SMEs) in joint procurement procedures. Particular emphasis should be placed on providing technical assistance and reducing the administrative burdens in order to boost the involvement of SMEs in the process.
Amendment 45 #
Proposal for a regulation Recital 9 c (new) (9c) During the existence of a cross- border health threat situation, manufacturing is often needed rapidly and with short notice. It is therefore crucial that the joint procurement lead times are aligned and coherent with manufacturers’ lead times to ensure clarity and expectations from both organizing and participating entities.
Amendment 46 #
Proposal for a regulation Recital 9 c (new) (9c) During a health crisis situation, manufacturing is often needed rapidly and with short notice. It is therefore crucial that the joint procurement lead times are aligned and coherent with manufacturers’ lead times to ensure clarity and expectations from both organizing and participating entities.
Amendment 47 #
Proposal for a regulation Recital 9 d (new) (9d) In order for this regulation to fulfil its main objectives, mainly to ensure a rapid response in the case of serious cross-border health threats, a priority conditionality binding the undertaking of the joint procurement procedures should be provided for, in order to ensure that the delivery and scheduled commitments to the participating countries are respected under all circumstances.
Amendment 48 #
Proposal for a regulation Recital 9 d (new) (9d) Regulatory flexibility should be considered and allowed to ensure faster supply to the markets, for example by accepting each other Marketing Authorizations in case of emergencies.
Amendment 49 #
Proposal for a regulation Recital 9 e (new) (9e) Joint procurement implies shared responsibilities and a fair approach with rights and obligations for all parties involved, relevant authorities and manufacturers. In this respect, commitments should be defined since the beginning and respected, from the manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes. This is also important to avoid waste of medicinal products.
Amendment 50 #
Proposal for a regulation Recital 9 e (new) (9e) In addition, suitable regulatory flexibilities should be considered and allowed by Member States’ authorities in the framework of joint procurement procedures and including, where relevant, for marketing authorisations, to ensure faster and timely supply in the European Single Market.
Amendment 51 #
Proposal for a regulation Recital 9 f (new) (9f) Joint procurement implies shared responsibilities and a fair approach with rights and obligations for all parties involved, relevant authorities and manufacturers. In this respect, commitments should be defined since the beginning and respected, from the manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes.
Amendment 52 #
Proposal for a regulation Recital 9 f (new) (9f) If used, in order for joint procurement to be sustainable, it is crucial to define criteria beyond the price/cost only to be considered in the awarding process. Such criteria should take into consideration for instance the ability of the bidder to ensure security of supply in a health crisis situation.
Amendment 53 #
Proposal for a regulation Recital 9 g (new) (9g) If used, in order for joint procurement to be sustainable, the Commission should ensure accessible, transparent, proportionate and non- discriminatory technical specifications, selection and award criteria by placing a significant and priority value and consideration on the highest safety and quality standards of the medical countermeasures, in accordance with the applicable legislation, and beyond the price and costs of those. Such criteria should also include the ability of the bidder to ensure security and capacity of supply in a cross-border health threat situation, as well as provide for adequate flexibility to allow for a wider selection of successful suppliers and the effective participation of small and medium-sized enterprises in the awarding process.
Amendment 54 #
Proposal for a regulation Recital 9 h (new) (9h) To facilitate the negotiation of joint procurement procedures, Member States should establish no-fault compensation systems which should be used in the event of a cross-border health threat declared by the EU, allowing citizens who may suffer an adverse reaction to a particular medical countermeasure, subject to a joint procurement procedure, to receive fair compensation by proving solely the causal link between the medical countermeasure in question and the damages caused. These possible damages should not be borne individually by each injured person, but should be considered as a social burden shared by society as a whole. Therefore, equal access to fair compensation through no-fault compensation schemes should be provided.
Amendment 55 #
Proposal for a regulation Recital 11 (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
Amendment 56 #
Proposal for a regulation Recital 13 a (new) (13a) Regular two-way communication and exchange of information between authorities, industry and relevant entities of the pharmaceutical supply chain should be encouraged to facilitate preliminary dialogue concerning foreseeable serious cross-border threats to health in the market by way of sharing information on the expected supply constraints, allowing better coordination, synergies and robust reaction if needed.
Amendment 57 #
Proposal for a regulation Recital 14 a (new) (14a) This Regulation ensures coordinated action at European Union’s level, in order to avoid the closure of internal borders and the paralysis of the internal market, which could threaten the circulation of basic supplies, including medicines, medical products and personal protective equipment (PPE). It is therefore necessary to ensure the correct implementation of European law in the field of export restrictions through a permanent notification mechanism.
Amendment 58 #
Proposal for a regulation Recital 15 (15) The Member States have a responsibility to manage public health crises at national level. However, measures taken by individual Member States could affect the interests of other Member States if they are inconsistent with one another or based on diverging risk assessments. The aim to coordinate the response at Union level should, therefore,
Amendment 59 #
Proposal for a regulation Recital 15 a (new) (15a) The European Commission shall 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 60 #
Proposal for a regulation Recital 17 (17) Inconsistent communication with the public and stakeholders such as healthcare
Amendment 61 #
Proposal for a regulation Recital 17 (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
Amendment 62 #
Proposal for a regulation Recital 17 (17) Inconsistent communication with the public and stakeholders such as healthcare professionals and failure to keep citizens informed 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
Amendment 63 #
Proposal for a regulation Recital 18 (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 through the creation of a new mechanism that increases the coordination and facilitates joint procurement procedures for the development, stockpiling and donation of medical countermeasures. In order to recognise such an emergency situation, the Commission should establish
Amendment 64 #
Proposal for a regulation Recital 18 (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
Amendment 65 #
Proposal for a regulation Recital 18 (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
Amendment 66 #
Proposal for a regulation Recital 20 (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
Amendment 67 #
Proposal for a regulation Recital 20 (20) The occurrence of an event that corresponds to serious cross-border threats to health and is likely to have Union-wide consequences should
Amendment 68 #
Proposal for a regulation Recital 23 (23) Since the objectives of this
Amendment 69 #
Proposal for a regulation Recital 24 a (new) (24a) National authorities should where appropriate consult and involve in the implementation of this regulation representative national social partners in the healthcare and social services sector.
Amendment 7 #
Proposal for a regulation Recital 1 a (new) (1a) Health provisions of the Treaties are still largely under-used in terms of the purposes they could be used to achieve. The aim is therefore to ensure that this Regulation makes the best possible use of the legal bases on health set out in the Treaty, in order to manifest the European Union’s strong health policy while preserving the normal functioning of the single market during serious cross-border threats to health.
Amendment 70 #
Proposal for a regulation Recital 25 (25) In order to ensure uniform conditions for the implementation of this
Amendment 71 #
Proposal for a regulation Recital 26 Amendment 72 #
Proposal for a regulation Recital 26 a (new) (26a) The recommendations of the World Health Organisation’s High Level Expert Group on Health Employment and Economic Growth (2016)1a to address workforce shortages shall be integrated in the preparedness plans to ensure adequate and needs- oriented staffing level. __________________ 1ahttps://www.who.int/hrh/com- heeg/reports/report-expert-group/en/
Amendment 73 #
Proposal for a regulation Recital 26 b (new) (26b) The COVID 19 health crisis has shown that neither the joint procurement of medical countermeasures or Union’s funding for research of them have proved to be a sufficient solution to tackle the public health emergency. In the event that a public health emergency is declared at Union level and instruments under this regulation, such as joint procurement of medical countermeasures, will prove that are not sufficient to address the health crisis, the Commission should in the future have the power to grant so-called compulsory licenses on patents on these medicines, vaccines and medical devices to European manufactures to enhance Union production capacity. The Commission and the Member States should consider possible delegation of power to grant compulsory licenses to Commission in the next revision of this Regulation.
Amendment 74 #
Proposal for a regulation Recital 27 Amendment 75 #
Proposal for a regulation Recital 28 (28) In order to ascertain the state of implementation of the national preparedness plans and their coherence with the Union plan, the
Amendment 76 #
Proposal for a regulation Article 1 – paragraph 1 – point c (c) joint procurement, management and deployment of medical countermeasures;
Amendment 77 #
Proposal for a regulation Article 2 – paragraph 1 – point c Amendment 78 #
Proposal for a regulation Article 2 – paragraph 1 – point d Amendment 79 #
Proposal for a regulation Article 2 – paragraph 6 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
Amendment 8 #
Proposal for a regulation Recital 1 a (new) (1a) Public health falls, as a matter of principle under the responsibility of the Member States, which are free to organise and deliver their health-care services in whatever manner they wish, as well as to procure medical devices, medicines, vaccines and health products, and to devise policies for cooperation and sharing of best practice, information and medical equipment, however they see fit.
Amendment 80 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 (7) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental, climate or unknown origin
Amendment 81 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 (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 Council23 and in Regulation (EU) 2017/745 of the European Parliament and of the Council24 or other goods or services for the
Amendment 82 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 a (new) (8a) ‘green lines’ means passable and safe passage transit corridors that in case of declared public health emergency at Union level allows Member States to preserve the free circulation of essential goods and medical countermeasures.
Amendment 83 #
Proposal for a regulation Article 4 – paragraph 1 – introductory part 1. The Health Security Committee (‘HSC’) is hereby established. It shall be composed of representatives of all the Member States, in two working formations:
Amendment 84 #
Proposal for a regulation Article 4 – paragraph 2 – point d (d) adoption of opinions and guidance, including on specific response measures for the Member States for the prevention and control of serious cross-border threats to health while taking into account the proper functioning of the single market.
Amendment 85 #
Proposal for a regulation Article 4 – paragraph 3 – introductory part 3. As far as possible, the group shall adopt its guidance or opinions by consensus. These decisions shall not be binding.
Amendment 86 #
Proposal for a regulation Article 4 – paragraph 6 – point c a (new) (ca) remote digital working in situations when the HSC cannot physically meet for justified reasons.
Amendment 87 #
Proposal for a regulation Article 4 – paragraph 7 – subparagraph 1 a (new) Recognised European social partners in the relevant EU sectoral social dialogue committees in the health and social services shall have an observer status in the HCS.
Amendment 88 #
Proposal for a regulation Article 5 – paragraph 3 – point e Amendment 89 #
Proposal for a regulation Article 5 – paragraph 3 – point f Amendment 9 #
Proposal for a regulation Recital 2 (2) In light of the lessons learnt during the ongoing COVID-19 pandemic, such as systemic weaknesses in the supply chain of certain medical devices and medicines in Europe, in particular dependence on China and India, and in order to facilitate adequate Union-wide preparedness and response to all cross-
Amendment 90 #
Proposal for a regulation Article 5 – paragraph 3 – point g Amendment 91 #
Proposal for a regulation Article 5 – paragraph 3 – point g a (new) (ga) adequate and needs- oriented staffing level;
Amendment 92 #
Proposal for a regulation Article 5 – paragraph 3 – point g b (new) (gb) adequate stock of personal protective equipment of the highest quality;
Amendment 93 #
Proposal for a regulation Article 5 – paragraph 3 – point g c (new) (gc) monitoring if adequate risk assessments, preparedness plans and trainings are foreseen for the health and social care at the work place level;
Amendment 94 #
Proposal for a regulation Article 5 – paragraph 3 – point g d (new) (gd) inclusiveness of the national health systems to ensure equal access to health and social services and to allow for quality treatments without a delay
Amendment 95 #
Proposal for a regulation Article 5 – paragraph 4 a (new) 4a. The Union preparedness and response plan also provides for measures to ensure the normal functioning of the single market during serious cross-border threat to health.
Amendment 96 #
Proposal for a regulation Article 6 – paragraph 1 1. When preparing national preparedness and response plans each Member State shall
Amendment 97 #
Proposal for a regulation Article 6 – paragraph 1 1. When preparing national preparedness and response plans each Member State shall consult national social partners and 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.
Amendment 99 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point ii (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, adequate stock of personal protective equipment of the highest quality;
source: 691.332
2021/04/30
ENVI
541 amendments...
Amendment 103 #
Proposal for a regulation Recital -1 (new) (-1) The COVID-19 pandemic has highlighted the risks to human health posed by the over-exploitation of wildlife and other natural resources and the accelerated loss of biodiversity. As the health of humans, animals and the environment are inextricably linked, it is crucial to take the ‘One Health’ approach to address current and emerging crises. This is paramount as the majority (72%) of emerging diseases of humans, including COVID-19, influenza and HIV/AIDS, are caused by zoonotic pathogens.
Amendment 104 #
Proposal for a regulation Recital -1 a (new) (-1 a) The Union’s ability to adequately respond to COVID-19 has been severely impeded by the absence of a clearly defined legal framework for managing its response to the pandemic, insufficient mandates of its health agencies and also by the limited degree of Union and Member State preparedness in case of a public health emergency impacting a majority of Member States.
Amendment 105 #
Proposal for a regulation Recital 1 (1) A network for the epidemiological surveillance and control of communicable diseases was set up by Decision No 2119/98/EC of the European Parliament and of the Council.13 Its scope was extended by Decision No 1082/2013/EU of the European Parliament and of the Council14 to strengthen and provide for a further coordinated and wider approach to health security at Union level. The implementation of that legislation confirmed that coordinated Union action on monitoring, early warning of and combating those threats adds value to the protection and improvement of human health. The implementation of this legislation is another sign with which the Union is committed to the conclusions of the Global Conference on Primary Health Care of Astana of 25 and 26 October 2018. _________________ 13Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Community (OJ L 268, 3.10.1998, p.1). 14Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 106 #
Proposal for a regulation Recital 1 a (new) (1 a) Among the most dangerous pathogens are the respiratory viruses, including orthopoxviruses such as smallpox, or novel influenzas, and coronaviruses. The Union, through its capabilities and know-how, should counter all these potential threats.
Amendment 107 #
Proposal for a regulation Recital 2 (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 b
Amendment 108 #
Proposal for a regulation Recital 2 (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 while respecting the data protection rules.
Amendment 109 #
Proposal for a regulation Recital 2 (2) In light of the lessons learnt during the ongoing COVID-19 pandemic and in order to facilitate adequate Union-wide prevention, preparedness and response to all cross-
Amendment 110 #
Proposal for a regulation Recital 2 a (new) (2 a) It is therefore necessary that the Union be a full-fledged complementary component of European health systems, providing a guarantee or a last-resource stakeholder in case of serious cross- border health threats. For this reason, the know-how, expertise and capabilities of Union agencies should be strengthened accordingly.
Amendment 111 #
Proposal for a regulation Recital 2 b (new) (2 b) Knowing that the SARS-CoV-2 virus has been uncannily good at disrupting cellular programming, the Union should prepare itself for all those serious cross-border threats that could have the same levels of cellular disruption, for which the sufficient and most reliable research and capabilities should be deployed.
Amendment 112 #
Proposal for a regulation Recital 2 c (new) (2 c) In October, 2019, the first Global Health Security Index reported of a world largely unprepared to deal with a pandemic. Inter alia, it stated that there was a lack of political will for accelerating health security in a perpetual cycle of panic and neglect, and that no country was fully prepared. With the current legislation, which builds upon the lessons- learned during the management of the COVID–19 pandemic, the Union wishes to amend this situation and prepare itself for future serious cross-border threats that may originate in epidemics or pandemics.
Amendment 113 #
Proposal for a regulation Recital 3 (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 these threats.
Amendment 114 #
Proposal for a regulation Recital 3 (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. The European Parliament should nominate observers for the HSC.
Amendment 115 #
Proposal for a regulation Recital 4 a (new) (4 a) There is plenty of scientific evidence that shows that health prevention and promotion policies (public health policies) are central to guaranteeing the right to health of citizens, and those are also the most efficient in terms of cost effectiveness. However, even today most of the budgets of the health systems of the majority of Member States are given very little space to policies for disease prevention and health promotion. The COVID-19 pandemic has firmly confirmed the importance of public health policies for our societies.
Amendment 116 #
Proposal for a regulation Recital 4 b (new) (4 b) It is necessary to remember that these prevention and promotion strategies concern all sectoral policies: fiscal, commercial, economic, agro- environmental, educational, housing, cultural, social assistance, etc. Health in all policies (HiAP) should be a non- negotiable principle of all public policies. An instrument already used at the national level is the so-called Health Test to assess the health impact of the different sectoral policies. It is necessary to deploy a Health Test methodology in all the programmes managed by the Union.
Amendment 117 #
Proposal for a regulation Recital 5 (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) amongst others. 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.
Amendment 118 #
Proposal for a regulation Recital 5 (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 and environmental matters, covering goods such as pharmaceutical products, medical devices
Amendment 119 #
Proposal for a regulation Recital 5 (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
Amendment 120 #
Proposal for a regulation Recital 6 (6)
Amendment 121 #
Proposal for a regulation Recital 6 (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
Amendment 122 #
Proposal for a regulation Recital 6 (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. These mechanisms should look for synergies between measures taken at the EU and national levels, as well as try to avoid duplications with measures undertaken in the context with 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
Amendment 123 #
Proposal for a regulation Recital 6 (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 and all relevant stakeholders, such as industry, supply chain actors, health professionals and patients associations, 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.
Amendment 124 #
Proposal for a regulation Recital 6 (6) The protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities and should ensure a “One Health” and “Health in all policies” approach. 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.
Amendment 125 #
Proposal for a regulation Recital 6 (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, as well as in close dialogue with 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. 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 126 #
Proposal for a regulation Recital 6 (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, as well as in close dialogue with 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. 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 127 #
Proposal for a regulation Recital 6 (6)
Amendment 128 #
Proposal for a regulation Recital 6 a (new) (6 a) Demographic change and technological innovation are some of the most important challenges facing our health systems. The aging of the population is largely due to the success of our healthcare systems and forces them, at the same time, to a structural transformation: from a healthcare model focused mainly on acute diseases, a shift is needed towards a healthcare model in which chronic diseases gain more weight and pandemics’ risk is significantly reduced. It is important that the Member States accompany each other in this process of transformation of the healthcare model, and for this reason it is necessary to strengthen good practices exchanging mechanisms.
Amendment 129 #
Proposal for a regulation Recital 7 (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. 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. This training should be consistent with the One-Health approach in recognition of the interlinks between human health, animal health and the environment. 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. Specific considerations should be given to border regions, where joint cross-border exercises should be promoted and familiarity with the public health system structures encouraged. Following stress tests and reviews of the plans, corrective actions should be implemented and the Commission should be kept informed of all updates.
Amendment 130 #
Proposal for a regulation Recital 7 (7) Preventing, 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. This exercise should be consistent with the One-Health approach in recognition of the interlinks between human health, animal health and the environment. 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. Specific considerations should be given to border regions, where joint cross-border exercises should be promoted and familiarity with the public health system structures encouraged. Following stress tests and reviews of the plans, corrective actions should be implemented and the Commission should be kept informed of all updates.
Amendment 131 #
Proposal for a regulation Recital 7 (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 include recommendations for policy interventions related to mitigation of the impact of communicable diseases on health services and care, including for non-communicable diseases (NCDs). The 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.
Amendment 132 #
Proposal for a regulation Recital 7 (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. Where appropriate, regional authorities should participate in the drawing of these plans. 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, facilitating the sharing of best practices. 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.
Amendment 133 #
Proposal for a regulation Recital 7 (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.
Amendment 134 #
Proposal for a regulation Recital 7 (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 H
Amendment 135 #
Proposal for a regulation Recital 7 a (new) (7 a) Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a 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 must therefore include plans to improve the preparedness, prevention 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 136 #
Proposal for a regulation Recital 7 a (new) (7 a) Preparedness and response planning are also essential elements in order to prevent a “doom loop” situation, namely a cycle of negative economic feedback. When the COVID–19 pandemic hit, the world suffered a supply shock, where trade was disrupted,factories and stores closed, then salaries where in danger, the supply shock could turn into a demand shock, and that would further weaken supply, which would increase unemployment and further diminish demand. In order to prevent a subsequent doom loop, the Union should make high- quality preparedness and response planning.
Amendment 137 #
Proposal for a regulation Recital 7 b (new) (7 b) Ensuring supply chain resilience across the Union is not a primordial mission of the Centre, yet the ECDC can provide data, knowledge, and skills, to the Commission and the EMA in order to ensure supply chain resilience in Europe. Supply chain resilience is part of the four working groups of the COVID– 19 taskforce of the EMA, alongside the therapeutic response, business continuity and impact, and human resources.
Amendment 138 #
Proposal for a regulation Recital 7 c (new) (7 c) It is therefore necessary that the European Medicines Agency (EMA) assist the Commission in assessing the supply chain resilience of these products and devices in order to achieve a sufficient strategic autonomy of the Union in health products and devices. Ensuring supply chain resilience across the Union is not a primordial mission of this authority, yet the EMA should provide data, knowledge, and skills, to the Commission and the ECDC in order to ensure supply chain resilience in Europe. Supply chain resilience is part of the four working groups of the COVID–19 taskforce of the EMA, alongside the therapeutic response, business continuity and impact, and human resources.
Amendment 139 #
Proposal for a regulation Recital 8 (8) Access to timely and complete data is a precondition for a rapid risk assessments and crisis mitigation. 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 . To avoid duplication of efforts and diverging recommendations, standardised definitions and fluid information exchange 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 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 agriculture, energy,
Amendment 140 #
Proposal for a regulation Recital 8 (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, including information on their strategic stockpiles and medical countermeasures available. 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
Amendment 141 #
Proposal for a regulation Recital 8 (8) To this end, Member States should provide the Commission with an update on
Amendment 142 #
Proposal for a regulation Recital 8 (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 long-term healthcare and 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. _________________ 15World Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/
Amendment 143 #
Proposal for a regulation Recital 8 (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. 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
Amendment 144 #
Proposal for a regulation Recital 8 (
Amendment 145 #
Proposal for a regulation Recital 8 (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,
Amendment 146 #
Proposal for a regulation Recital 8 a (new) (8 a) 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 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 health, social and territorial cohesion work they carry out.
Amendment 147 #
Proposal for a regulation Recital 8 a (new) (8 a) Health literacy plays a fundamental role in preventing and mitigating the impact of cross-borders threats and contributing to a better understanding by 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 148 #
Proposal for a regulation Recital 8 a (new) (8 a) Building on lessons learnt from the COVID-19 pandemic, this Regulation should create a more robust mandate for coordination at EU-level. The declaration of an EU emergency situation would trigger increased coordination and allow for timely development, stockpiling and joint procurement of medical countermeasures.
Amendment 149 #
Proposal for a regulation Recital 9 (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 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 Council16
Amendment 150 #
Proposal for a regulation Recital 9 (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,
Amendment 151 #
(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. Countries participating in the joint procurement procedure shall not negotiate and sign parallel contracts with producers. 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 Council16 . National stockpiles should be coordinated in view of the creation of a common EU strategic reserve of medical countermeasure and to prevent imbalances in the internal market. The functioning of the Joint Procurement Agreement and rescEU should abide by high standards of transparency, including in relation to the disclosure of the exact amount ordered and provided to each participating country, and delivery of procured products, and details of the liability of participating countries. _________________
Amendment 152 #
Proposal for a regulation Recital 9 (9) As serious cross-border threats to health are not limited to Union borders, the Union should adopt a coordinated approach in fighting against such threats. The joint procurement of medical countermeasures should, therefore, 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. In times of crisis, the Union should also aim to support access to medical countermeasures for Eastern Partnership and low- and middle-income countries. 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 Council16 . The Member States should ensure a sufficient reserve of critical medical products at Member State level to counter the risk of shortages of critical products. _________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
Amendment 153 #
Proposal for a regulation Recital 9 (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. Joint procurement of medical countermeasures will strengthen the purchasing power of participating countries, improve the security of supply and ensure equitable access to medical countermeasures against serious cross- border threats to health. 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. All Joint Procurement Agreements should adhere to the highest level of transparency to allow public scrutiny of the contracts. 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
Amendment 154 #
Proposal for a regulation Recital 9 (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,
Amendment 155 #
Proposal for a regulation Recital 9 (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
Amendment 156 #
Proposal for a regulation Recital 9 (9) As serious cross-border threats to health are not limited to Union borders,
Amendment 157 #
Proposal for a regulation Recital 9 (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 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 Council16 . _________________ 16Decision No 1313/2013/EU of the European Parliament and of the Council of 17 December 2013 on a Union Civil Protection Mechanism (OJ L 347, 20.12.2013, p. 924).
Amendment 158 #
Proposal for a regulation Recital 9 (9) As serious cross-border threats to health are not limited to Union borders,
Amendment 159 #
Proposal for a regulation Recital 9 a (new) (9 a) Joint procurement should be limited to serious cross-border treats to health and should not impact pre-existing contractual agreements with suppliers of medical countermeasures and should be carried in accordance with the Directive 2014/24/EU in a transparent manner, while respecting the following conditions: the procurement process, criteria, timelines, specifications, and formalities must be transparent and workable; a preliminary consultation phase involving potential participating manufacturers must take place; clear volume commitments irrespective of the selected supply modality must be ensured; participating countries need to commit not to procure the same medicines via other means; joint procurement lead times must be aligned with manufacturing processes lead times; national authorities should apply certain regulatory flexibilities; award criteria beyond price should be defined. Any joint procurement endeavour shall prevent market disruptions both in participating countries and other Member States not participating.
Amendment 160 #
Proposal for a regulation Recital 9 a (new) (9a) In order to counteract not only the Union’s dependence on third countries but also the vicissitudes of manufacturing and disruptions in the supply chain, recalls the importance of diversified supplies and procurement practices for pharmaceuticals and the need to swiftly propose guidelines for the Member States, notably on how to best implement the most economically advantageous tender criteria, looking beyond the lowest price criterion only; investments in the manufacture of active ingredients and medicinal end products in the EU should also be retained as a criterion, as well as the number and location of production sites, the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards;
Amendment 161 #
Proposal for a regulation Recital 9 a (new) (9 a) Since one of the primary responsibility of the Member States is to ensure the protection of their citizens, additional flexibility is needed when it comes to being able to adjust contractual provisions after the initial contract has been established, in order to increase, decrease or cancel the order for the medical counter measures, taking into account significant changes in circumstances which may occur. In order to protect the contractors directly engaged in activities that serve Union policies, such contractual adjustments should be duly justified by the national authorities participating in the joint procurement procedure, by explaining the seriousness or urgency of the circumstances in question and such adjustments should be enforced in close cooperation with contracted partners and taking due account of the commitments made up to date of contractual adjustment.
Amendment 162 #
Proposal for a regulation Recital 9 a (new) (9 a) Other mechanisms should be used to enable global response and crises mitigation. These include enhanced cooperation agreements on production of medical countermeasures, both voluntary and compulsory technology know-how pools and licensing agreements between companies. Triggering such mechanisms should guarantee equitable access to necessary counter-measures to global populations, including those in low-and middle-income countries.
Amendment 163 #
Proposal for a regulation Recital 9 a (new) (9 a) Joint procurement should be based on shared responsibilities and a fair approach for all parties involved, both relevant authorities and manufacturers. Clear commitments should be ensured and respected for all parties involved, from the manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes;
Amendment 164 #
Proposal for a regulation Recital 9 a (new) (9 a) The primary purpose of joint procurement should be to guarantee stability in an unpredictable environment in the context of a cross-border health crisis only, ensuring equitable access for patients and increased visibility and predictability for actors involved;
Amendment 165 #
Proposal for a regulation Recital 9 a (new) (9 a) Regulatory flexibility should be considered and allowed to ensure faster supply to the markets of the different Member States, for example by accepting each other Marketing Authorizations in case of emergencies;
Amendment 166 #
Proposal for a regulation Recital 9 b (new) Amendment 167 #
Proposal for a regulation Recital 9 b (new) (9 b) The joint procurement shall be carried in a transparent, timely and effective way to prevent market disruption and to ensure all actors involved shall fulfil their contractual responsibilities. Clear and transparent stages should be defined for the process, scope, specifications, timelines and formalities;
Amendment 168 #
Proposal for a regulation Recital 9 b (new) (9 b) If joint deployment is deployed, qualitative criteria should also be considered in the awarding process in addition to cost. Such criteria should also take into consideration, for example, the ability of the manufacturer to ensure security of supply during a health crisis;
Amendment 169 #
Proposal for a regulation Recital 9 c (new) (9 c) During a health crisis situation, manufacturing is often needed rapidly and at short notice. It is therefore crucial that the joint procurement lead times are aligned and coherent with manufacturers’ lead times to ensure clarity and expectations from both organizing and participating entities;
Amendment 170 #
Proposal for a regulation Recital 9 d (new) (9 d) Regulatory flexibility should be considered and allowed to ensure faster supply to the markets, for example by accepting each other Marketing Authorizations in case of emergencies;
Amendment 171 #
Proposal for a regulation Recital 9 e (new) (9 e) Joint procurement implies shared responsibilities and a fair approach with rights and obligations for all parties involved, relevant authorities and manufacturers. In this respect, commitments should be defined from the beginning and respected, by the manufacturers to deliver on the production, and by the authorities to purchase their agreed reserved volumes. This is also important to avoid waste of medicinal products;
Amendment 172 #
Proposal for a regulation Recital 9 f (new) (9 f) If used, in order for joint procurement to be sustainable, it is crucial to define criteria beyond the price/cost only to be considering in the awarding process. Such criteria should take into consideration for instance the ability of the bidder to ensure security of supply in a health crisis situation;
Amendment 173 #
Proposal for a regulation Recital 10 (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 non- communicable diseases, including the continuity of screening, diagnosis, monitoring, treatment and care in the healthcare system;
Amendment 174 #
Proposal for a regulation Recital 10 (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. The ECDC should also monitor the impact of communicable diseases on diseases that are not communicable(such as mental diseases), taking into account existing datasets, tools and registers.
Amendment 175 #
Proposal for a regulation Recital 10 a (new) (10 a) An increasing number of Member States are seeking to establish national stockpiles of medical countermeasures, that generates a stark increase in demand as a result that far exceeds patient demand forecasts based on epidemiological need and create sudden large spikes in demand that can place considerable strain on suppliers and, as a result, lead to challenges in meeting demand in other countries and create imbalances in the internal market particularly affecting the smaller countries;
Amendment 176 #
Proposal for a regulation Recital 11 (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. In times of crisis, particular attention should also 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 177 #
Proposal for a regulation Recital 11 (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 or major non-communicable diseases.
Amendment 178 #
Proposal for a regulation Recital 11 (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.
Amendment 179 #
Proposal for a regulation Recital 11 (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, cancer, and mental health.
Amendment 180 #
Proposal for a regulation Recital 12 (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, together with pharmacies and other licensed health care establishments, also testing for 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
Amendment 181 #
Proposal for a regulation Recital 12 (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, 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 182 #
Proposal for a regulation Recital 12 (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 or under 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 to serve this dual purpose.
Amendment 183 #
Proposal for a regulation Recital 12 (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
Amendment 184 #
Proposal for a regulation Recital 12 a (new) (12 a) In order to improve early preparedness 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 by the ECDC. Strengthening coordination and information with Member States on strategic stockpiles and medical countermeasures available is necessary to enhance the collection, modelling and use of prospective data that allows early alert notifications in the EU.
Amendment 185 #
Proposal for a regulation Recital 13 (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. The notification system of the EWRS should be an electronic, digital, interoperable platform which may also be built upon distributed ledger technology (DLT) and include data from national and regional competent authorities. Finally, this platform should also be linked to the Health dataspace.
Amendment 186 #
Proposal for a regulation Recital 13 (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 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 187 #
Proposal for a regulation Recital 13 a (new) (13a) In order to enable medicinal products to be made available during the COVID19 pandemic, marketing authorisation holders were allowed regulatory flexibilities, by for example covering procedures for changes in the suppliers of active pharmaceutical ingredients, the designation of new manufacturing sites and faster import authorisations, in order to better mitigate the shortage of medicines. These solutions should be made permanent in order to be able to respond to future situations and these flexibilities should be applied by Member States in a consistent manner to avoid fragmentation of the internal market and ineffective outcomes.
Amendment 188 #
Proposal for a regulation Recital 13 a (new) (13 a) Regular dialogue and exchange of information between authorities, industry, relevant entities of the pharmaceutical supply chain, healthcare professionals' and patients' organizations should also be ensured to start early discussions about expected potential serious cross-border threats to health in the market by way of sharing expected supply constraints or raising of specific clinical needs, allowing better coordination, synergies and appropriate reaction when needed.
Amendment 189 #
Proposal for a regulation Recital 13 a (new) (13 a) Regular two-way communication and exchange of information between authorities, industry and relevant entities of the pharmaceutical supply chain should also be ensured to start early discussions about expected potential serious cross-border threats to health in the market by way of sharing expected supply constraints, allowing better coordination, synergies and appropriate reaction when needed.
Amendment 190 #
Proposal for a regulation Recital 14 (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
Amendment 191 #
Proposal for a regulation Recital 14 (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 science, 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.
Amendment 192 #
Proposal for a regulation Recital 14 a (new) (14 a) Member States, the Commission and Union agencies should identify recognised public health organisations and experts, both in the area of communicable and non-communicable diseases, and other relevant stakeholders across sectors, applying the One Health approach, 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. Full compliance with transparency and conflict of interest rules for stakeholder engagement should be ensured.
Amendment 193 #
Proposal for a regulation Recital 15 (15) The Member States have a responsibility to manage public health crises at national and regional level. However, measures taken by individual Member States could affect the interests of other Member States if they are inconsistent with one another or based on diverging risk assessments. The aim to coordinate the response at Union level should, therefore, seek to ensure, inter alia, that measures taken at national and regional level
Amendment 194 #
Proposal for a regulation Recital 16 (16) To this effect, the HSC responsible for the coordination of response at Union level, should assume additional responsibility for the adoption of opinions and guidance for Member States related to the prevention and control of a serious cross border threats to health. Furthermore, should the coordination of national and regional public health measures prove insufficient to ensure an adequate Union response, the Commission should further support Member States via the adoption of recommendations on temporary public health measures.
Amendment 195 #
Proposal for a regulation Recital 16 (16) To this effect, the HSC responsible
Amendment 196 #
Proposal for a regulation Recital 17 (17) Inconsistent communication with the public and stakeholders such as healthcare professionals as well as those dedicated to research, development and innovation, 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 and regional needs and circumstances. In those Member States with regions having health competences, the information should also come from these regions towards their Member State and the Commission. 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
Amendment 197 #
Proposal for a regulation Recital 17 (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. In addition to the recommendations targeted at Member States and healthcare professionals, the ECDC should broaden its communication activities to provide key information available in all EU languages to the general public and serve as a point of reference and reliable source of information. 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
Amendment 198 #
Proposal for a regulation Recital 18 (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, taking into account the urgency of the situation where the Commission may have to recognise the public health emergency 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
Amendment 199 #
Proposal for a regulation Recital 18 (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
Amendment 200 #
Proposal for a regulation Recital 18 (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
Amendment 201 #
Proposal for a regulation Recital 18 (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
Amendment 202 #
Proposal for a regulation Recital 18 (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
Amendment 203 #
Proposal for a regulation Recital 18 (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
Amendment 204 #
Proposal for a regulation Recital 18 (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, and representatives of civil society, selected by the Commission from the fields of expertise
Amendment 205 #
Proposal for a regulation Recital 19 (19) Before recognising a situation of public health emergency at Union level, the Commission should liaise with the WHO in order to share the Commission’s analysis of the situation of the outbreak and to inform the WHO of its intention to adopt such a decision. Where such a recognition is adopted, the Commission should also inform the WHO thereof. The liaison with the WHO should not question the Union’s strategic autonomy in countering the serious cross-border threats or outbreaks within its borders.
Amendment 206 #
(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 or infection, between those Member States directly involved in the contact-tracing
Amendment 207 #
Proposal for a regulation Recital 21 (21) Cooperation with third countries and international organisations in the field
Amendment 208 #
Proposal for a regulation Recital 21 (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
Amendment 209 #
Proposal for a regulation Recital 21 a (new) (21 a) The Commission and the Member States should actively work towards a new global treaty for pandemic preparedness and response under the framework of the World Health Organization and with close involvement of other relevant organizations, building on and improving the existing global health instruments, especially the International Health Regulations (2005)1a to ensure a firm and tested foundation. Such a Treaty should support and focus on strengthening the international health framework and improving cooperation with regard to early detection, prevention, response and resilience to future pandemics. _________________ 1aWorld Health Organization. International Health Regulation (IHR, 2005) https://www.who.int/ihr/publications/9789 241596664/en/
Amendment 210 #
Proposal for a regulation Recital 22 (22) Due to the sensitive nature of the health data, Member States, the Commission and Union agencies should safeguard and guarantee that their processing operations respect the data protection principles of lawfulness, fairness, transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity and confidentiality. 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 Council19 . 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. Article 27 of Regulation (EU) 2018/1725 EUDPR should be strictly respected and appropriate technical and organisational security measures in accordance with Article 33 EUDPR should be put in place. _________________ 19Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
Amendment 211 #
Proposal for a regulation Recital 22 (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 Council19 . 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 and regional 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. _________________ 19Regulation (EU) 2018/1725 of the European Parliament and of the Council of
Amendment 212 #
Proposal for a regulation Recital 22 (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 Council19 . 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
Amendment 213 #
Proposal for a regulation Recital 24 (24) As responsibility for public health is not an exclusively national matter in certain Member States, but is substantially decentralised, national and regional authorities should, where appropriate, involve the relevant competent authorities in the implementation of this Regulation.
Amendment 214 #
Proposal for a regulation Recital 25 (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,
Amendment 215 #
Proposal for a regulation Recital 25 (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;
Amendment 216 #
Proposal for a regulation Recital 25 (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
Amendment 217 #
Proposal for a regulation Recital 25 a (new) (25 a) National authorities should where appropriate consult and involve in the implementation of this regulation representatives of patients organisations and national social partners in the healthcare and social services sector.
Amendment 218 #
Proposal for a regulation Recital 25 b (new) (25 b) The recommendations of the World Health Organization’s High Level Expert Group on Health Employment and Economic Growth1a to address workforce shortages shall be integrated in the prevention, preparedness and respons plans to ensure adequate and needs- oriented staffing level. _________________ 1ahttps://www.who.int/hrh/com- heeg/reports/report-expert-group/en/
Amendment 219 #
Proposal for a regulation Recital 28 (28) In order 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 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
Amendment 220 #
Proposal for a regulation Recital 28 a (new) (28 a) The COVID 19 health crisis has shown that neither the joint procurement of medical countermeasures nor Union funding for research into them have proved to be a sufficient solution to tackle the public health emergency. In the event that a public health emergency is declared at Union level and instruments under this regulation, such as joint procurement of medical countermeasures, will prove that are not sufficient to address the health crisis, the Commission should in the future have the power in line with the WTO rules to grant so-called compulsory licenses on patents on these medicines, vaccines and medical devices to Union manufacturers to enhance Union production capacity. Asks the Commission and the Member States to consider the possible delegation of power to grant compulsory licenses to the Commission in the next revision of this Regulation.
Amendment 221 #
Proposal for a regulation Article 1 – paragraph 1 – point b – point i (i) preparedness plans at Union and national and regional levels;
Amendment 222 #
Proposal for a regulation Article 1 – paragraph 1 – point b – point ii (ii) reporting and
Amendment 223 #
Proposal for a regulation Article 1 – paragraph 2 – point b a (new) (b a) a network of national strategic stockpiles and medical countermeasures available;
Amendment 224 #
Proposal for a regulation Article 1 – paragraph 3 3.
Amendment 225 #
Proposal for a regulation Article 1 – paragraph 3 3.
Amendment 226 #
Proposal for a regulation Article 1 – paragraph 3 a (new) 3 a. The implementation of this Regulation shall be carried out in full respect for the dignity and fundamental rights and freedoms of persons and shall ensure the “One health” and “Health in all Policies” approaches.
Amendment 227 #
Proposal for a regulation Article 1 – paragraph 3 a (new) 3a. This Regulation shall ensure that in future health emergencies, the detection, health interventions and treatment of other serious diseases are not halted.
Amendment 228 #
Proposal for a regulation Article 1 – paragraph 3 a (new) 3 a. The implementation of this Regulation shall be with full respect for the dignity and fundamental rights and freedoms of persons.
Amendment 229 #
Proposal for a regulation Article 2 – paragraph 1 – point a – point i (i) communicable diseases, including communicable diseases of zoonotic origin;
Amendment 230 #
Proposal for a regulation Article 2 – paragraph 1 – point a – point i (i) communicable diseases, including of zoonotic origin;
Amendment 231 #
Proposal for a regulation Article 2 – paragraph 1 – point a – point iii a (new) (iii a) rare diseases of biological origin;
Amendment 232 #
Proposal for a regulation Article 2 – paragraph 1 – point c Amendment 233 #
Proposal for a regulation Article 2 – paragraph 1 – point e (e) events which may constitute public health emergencies of international concern under the International Health Regulations (IHR), provided that they fall under one of the categories of threats set out in points (a) to (d).
Amendment 234 #
Proposal for a regulation Article 2 – paragraph 1 – point e a (new) (ea) This Regulation shall apply where an emergency situation is recognised, as set out in Article 23 of this Regulation.
Amendment 235 #
Proposal for a regulation Article 2 – paragraph 2 2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases
Amendment 236 #
Proposal for a regulation Article 2 – paragraph 2 2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues, such as non- communicable diseases, or health consequences such as mental health conditions.
Amendment 237 #
Proposal for a regulation Article 2 – paragraph 3 a (new) 3 a. This Regulation shall promote the implementation of the International Health Regulation, reduce administrative burden and duplication of resources, and strengthen the gaps unveiled from the COVID-19 pandemic in prevention, preparedness and response to public health threats.
Amendment 238 #
Proposal for a regulation Article 2 – paragraph 4 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
Amendment 239 #
Proposal for a regulation Article 2 – paragraph 5 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 240 #
Proposal for a regulation Article 2 – paragraph 6 6. Member States shall retain the right to maintain or introduce additional arrangements, procedures and measures for their national and regional 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.
Amendment 241 #
Proposal for a regulation Article 2 – paragraph 6 a (new) 6a. The European Commission shall establish an electronic information system to ensure transparency, facilitate easy access for all EU citizens and combat disinformation.
Amendment 242 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 Amendment 243 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (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 communicable or infectious disease, through manual or other technological means;
Amendment 244 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (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
Amendment 245 #
Proposal for a regulation Article 3 – paragraph 1 – point 4 (4) ‘epidemiological surveillance’ means the systematic collection, recording, analysis, interpretation and dissemination of data and analysis on communicable diseases and related special health issues as well as their impact on non- communicable diseases or health consequences such as mental health conditions;
Amendment 246 #
Proposal for a regulation Article 3 – paragraph 1 – point 5 a (new) (5 a) ‘One Health’ is a collaborative, multi-sectoral, and transdisciplinary approach to designing and implementing programmes, policies, legislation and research in which multiple sectors communicate and work together to achieve better public health outcomes, recognising the interconnection between people, animals, plants, and their shared environment;
Amendment 247 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 (7) ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental, climate or unknown origin which spreads or entails a significant risk of coming from third countries to the territories of Member States and/or spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection;
Amendment 248 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 (
Amendment 249 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 Amendment 250 #
Proposal for a regulation Article 3 – paragraph 1 – point 7 a (new) (7 a) ‘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 251 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 a (new) Amendment 252 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 a (new) (8 a) ‘Health in all policies’ means health in all policies as defined in Regulation (EU) .../... EU 4 Health [OJ: ...]
Amendment 253 #
Proposal for a regulation Article 3 – paragraph 1 – point 8 b (new) (8 b) ‘One Health approach’ means One health approach as defined in Regulation(EU) .../... EU 4 Health [OJ: ...]
Amendment 254 #
Proposal for a regulation Article 4 – paragraph 1 a (new) Amendment 255 #
Proposal for a regulation Article 4 – paragraph 2 – point a (a) enabling of coordinated action by the Commission and the Member States, including the national health authorities, for the implementation of this Regulation;
Amendment 256 #
Proposal for a regulation Article 4 – paragraph 2 – point b (b) coordination in liaison with the Commission and relevant Union agencies of the preparedness and response planning of the Member States in accordance with Article 10;
Amendment 257 #
Proposal for a regulation Article 4 – paragraph 2 – point b (b) coordination in liaison with the Commission and the Member States of the preparedness and response planning of the Member States in accordance with Article 10;
Amendment 258 #
Proposal for a regulation Article 4 – paragraph 2 – point b (b) coordination in liaison with the Commission of the prevention, preparedness and response planning of the Member States in accordance with Article 10;
Amendment 259 #
Proposal for a regulation Article 4 – paragraph 2 – point c (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 260 #
Proposal for a regulation Article 4 – paragraph 2 – point c (c) coordination in liaison with the Commission and the Member States 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 261 #
Proposal for a regulation Article 4 – paragraph 2 – point d (
Amendment 262 #
Proposal for a regulation Article 4 – paragraph 2 – point d a (new) Amendment 263 #
Proposal for a regulation Article 4 – paragraph 2 – point d a (new) (d a) support policies that guarantee the health in all policies principle and the One Health approach;
Amendment 264 #
Proposal for a regulation Article 4 – paragraph 2 – subparagraph 1 (new) The relevant Union agencies shall be involved in fulfilling the tasks of the HSC.
Amendment 265 #
Proposal for a regulation Article 4 – paragraph 2 – point d b (new) (d b) exchange good practices in order to make it easier for Member States to make the transition towards a healthcare model where aging and chronicity have gained relevance;
Amendment 266 #
Proposal for a regulation Article 4 – paragraph 2 – point d c (new) (d c) strengthen public sector participation in health research strategies, in coherence with the Horizon Europe programme, in order to reinforce the necessary resources so that all strategic health research that cannot be done without public support may be carried out;
Amendment 267 #
Proposal for a regulation Article 4 – paragraph 4 4. The HSC shall be chaired by a representative of the Commission
Amendment 268 #
Proposal for a regulation Article 4 – paragraph 4 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 269 #
Proposal for a regulation Article 4 – paragraph 5 5. The secretariat shall be provided by the Commission and shall be instituted within the competent directorate general of the Commission.
Amendment 270 #
Proposal for a regulation Article 4 – paragraph 5 a (new) Amendment 271 #
Proposal for a regulation Article 4 – paragraph 6 – introductory part 6. The HSC shall adopt, by a majority of two thirds of its members, its rules of procedure. Those rules of procedure shall establish working arrangements and competences without prejudice to the principle of proportionality and subsidiarity, in particular with regard to:
Amendment 272 #
Proposal for a regulation Article 4 – paragraph 6 – point b (b) the participation of experts in plenary meetings
Amendment 273 #
Proposal for a regulation Article 4 – paragraph 7 – introductory part 7. Member States shall designate one representative and not more than two alternate members of the HSC in each working formation referred to in paragraph 1. Member States shall designate their representatives and alternate members within 30 days after the entry into force of this Regulation. In case a representative or an alternate representative cedes her or his responsibilities within the HSC, the Member State shall designate a substitute or substitutes within 30 days.
Amendment 274 #
Proposal for a regulation Article 4 – paragraph 7 – subparagraph 1 a (new) In case the Member State has not designated any substitute within 30 days after the termination of the previous representative or alternate member, the HSC shall nevertheless continue its undertakings after an official letter sent to the Member State by the Chair of the HSC.
Amendment 275 #
Proposal for a regulation Article 4 – paragraph 7 – subparagraph 1 a (new) Recognised European social partners in the relevant EU sectoral social dialogue committees in the health and social services and the representative of patient's organizations shall have observer status in the HSC.
Amendment 276 #
Proposal for a regulation Article 4 – paragraph 7 – subparagraph 1 b (new) The European Parliament shall nominate two observers, elected by its Committee on Environment, Public Health and Food Safety. These observers shall be elected during the European Parliament’s mandate. Each observer shall be elected for a maximum of five years.
Amendment 277 #
Proposal for a regulation Article 4 – paragraph 7 a (new) 7 a. The list of members of the Health Security Committee at both the political and technical levels shall be made public on the Commission and Council websites. Members of the Committee must 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 indirect interests which could relate to the medical or other relevant industry shall be entered in a register held by the Commission and be accessible to the public, upon request.
Amendment 278 #
Proposal for a regulation Article 4 – paragraph 7 a (new) 7 a. The European Parliament shall designate representatives to participate in the Health Security Committee (HSC) as observers.
Amendment 279 #
Proposal for a regulation Article 4 – paragraph 7 b (new) 7 b. The rules of procedure, guidance, agendas and minutes of the meetings of the HSC shall be published on the Commission’s web-portal. To allow further public scrutiny by the European Parliament, the Commission shall be invited for an annual exchange of view regarding the work of the HSC with the Committee on the Environment, Public Health and Food Safety (ENVI).
Amendment 280 #
II PREVENTION, PREPAREDNESS AND RESPONSE PLANNING
Amendment 281 #
Proposal for a regulation Chapter II – title II PREVENTION, PREPAREDNESS AND RESPONSE PLANNING
Amendment 282 #
Proposal for a regulation Chapter II – title II PREVENTION, PREPAREDNESS AND RESPONSE PLANNING
Amendment 283 #
Proposal for a regulation Article 5 – title Union prevention, preparedness and response plan
Amendment 284 #
Proposal for a regulation Article 5 – paragraph 1 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 preparedness and response plan’) to promote effective and coordinated response to cross-border health threats at Union level.
Amendment 285 #
Proposal for a regulation Article 5 – paragraph 1 Amendment 286 #
Proposal for a regulation Article 5 – paragraph 1 1. The Commission, in cooperation with Member States and the relevant Union agencies, 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 287 #
Proposal for a regulation Article 5 – paragraph 2 2. The Union preparedness and response plan shall complement the national and regional preparedness and response plans established in accordance with Article 6.
Amendment 288 #
Proposal for a regulation Article 5 – paragraph 2 2. The Union prevention, preparedness and response plan shall complement the national preparedness and response plans established in accordance with Article 6.
Amendment 289 #
Proposal for a regulation Article 5 – paragraph 2 2. The Union preparedness and response plan shall complement the national preparedness and response plans established in accordance with Article 6.
Amendment 290 #
Proposal for a regulation Article 5 – paragraph 3 – introductory part 3. The Union prevention, preparedness and response plan shall, in particular, include arrangements for governance, capacities and resources for:
Amendment 291 #
Proposal for a regulation Article 5 – paragraph 3 – point a (a) the timely cooperation between the Commission, the Member States, regions with health competences, and the Union agencies;
Amendment 292 #
Proposal for a regulation Article 5 – paragraph 3 – point b (b) the secure exchange of information between the Commission, Union agencies, regions with health competences, and the Member States;
Amendment 293 #
Proposal for a regulation Article 5 – paragraph 3 – point b a (new) (b a) the mapping of the strategic production capacities for the Union as a whole;
Amendment 294 #
Proposal for a regulation Article 5 – paragraph 3 – point c (c) the epidemiological surveillance and monitoring, as well as the impact of communicable diseases on non- communicable diseases;
Amendment 295 #
Proposal for a regulation Article 5 – paragraph 3 – point c a (new) (c a) the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions during health emergencies;
Amendment 296 #
Proposal for a regulation Article 5 – paragraph 3 – point e (e) the risk and crisis communication, for health professionals and for citizens;
Amendment 297 #
Proposal for a regulation Article 5 – paragraph 3 – point f (f) the health preparedness and response and intersectoral collaboration, including between the health and veterinary sectors in cases of cross-border zoonotic health threats;
Amendment 298 #
Proposal for a regulation Article 5 – paragraph 3 – point g a (new) (ga) the establishment of a European stock of critical medicines and medical countermeasures as part of the rescEU emergency reserve;
Amendment 299 #
Proposal for a regulation Article 5 – paragraph 3 – point g a (new) (g a) the continuity of healthcare services, particularly for chronic conditions;
Amendment 300 #
Proposal for a regulation Article 5 – paragraph 3 – point g a (new) (g a) adequate and needs-oriented staffing level;
Amendment 301 #
Proposal for a regulation Article 5 – paragraph 3 – point g b (new) (g b) adequate stock of personal protective equipment of the highest quality;
Amendment 302 #
Proposal for a regulation Article 5 – paragraph 3 – point g b (new) (g b) the criteria to activate and deactivate the plan.
Amendment 303 #
Proposal for a regulation Article 5 – paragraph 3 – point g c (new) (g c) monitoring if adequate risk assessments, preparedness plans and trainings are foreseen for the health and social care at the workplace level;
Amendment 304 #
Proposal for a regulation Article 5 – paragraph 3 – point g d (new) (g d) inclusiveness of the national health systems to ensure equal access to health and social services and to allow for quality treatments without a delay.
Amendment 305 #
Proposal for a regulation Article 5 – paragraph 4 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
Amendment 306 #
Proposal for a regulation Article 5 – paragraph 4 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 plan should include recommendations for policy interventions related to mitigation of the impact of communicable diseases on health services and care, including for non-communicable diseases (NCDs). The plans shall include preparedness and response means to address the situation of those citizens with higher risks.
Amendment 307 #
Proposal for a regulation Article 5 – paragraph 4 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, as well as to ensure the continuity of critical long-term healthcare services for time sensitive, chronic, degenerative and other life-threatening diseases.
Amendment 308 #
Proposal for a regulation Article 5 – paragraph 4 4. The Union preparedness and response plan shall include cross-border and interregional preparedness
Amendment 309 #
Proposal for a regulation Article 5 – paragraph 4 4. The Union prevention, 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.
Amendment 310 #
Proposal for a regulation Article 5 – paragraph 4 4. The Union prevention, 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.
Amendment 311 #
Proposal for a regulation Article 5 – paragraph 4 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 plan
Amendment 312 #
Proposal for a regulation Article 5 – paragraph 5 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. The prevention, preparedness and response plan will take into account health systems data and relevant data to be collected at national level. Based on EU health systems data, the European Commission should issue recommendations as to ratios of resources in relation to population unit for baseline universal health coverage and emergencies, including the option of pooling resources at Union level.
Amendment 313 #
Proposal for a regulation Article 5 – paragraph 5 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 will take into account health systems data and relevant data to be collected at national or regional level.
Amendment 314 #
Proposal for a regulation Article 5 – paragraph 5 a (new) Amendment 315 #
Proposal for a regulation Article 5 – paragraph 5 b (new) 5 b. The reviews and the following corrective actions shall be published to increase the transparency of the process of prevention, preparedness and response plans.
Amendment 316 #
Proposal for a regulation Article 6 – title National and regional preparedness and response plans
Amendment 317 #
Proposal for a regulation Article 6 – title National prevention, preparedness and response plans
Amendment 318 #
Proposal for a regulation Article 6 – title National prevention, preparedness and response plans
Amendment 319 #
Proposal for a regulation Article 6 – paragraph 1 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. Coordination, dialogue and exchange of information with industry and supply chain stakeholders should also be considered.
Amendment 320 #
Proposal for a regulation Article 6 – paragraph 1 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. Coordination, dialogue and exchange of information with industry and supply chain stakeholders shall also be ensured.
Amendment 321 #
Proposal for a regulation Article 6 – paragraph 1 1. When preparing national prevention, preparedness and response plans each Member State shall consult patient's organizations, healthcare professionals organizations and national social partners and coordinate with the Commission in order to reach consistency with the Union prevention, preparedness and response plan, also inform without delay the Commission and the HSC of any substantial revision of the national plan.
Amendment 322 #
Proposal for a regulation Article 6 – paragraph 1 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, including disclosing national stockpiling requirements and the management of EU strategic reserves, also inform without delay the Commission and the HSC of any substantial revision of the national plan.
Amendment 323 #
Proposal for a regulation Article 6 – paragraph 1 1.
Amendment 324 #
Proposal for a regulation Article 6 – paragraph 1 1. When preparing national and regional preparedness and response plans each Member State and region with health competences 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 and regional plan.
Amendment 325 #
Proposal for a regulation Article 6 – paragraph 1 1. When preparing national preparedness and response plans each Member State shall coordinate with the Commission in order to reach synergies and consistency
Amendment 326 #
Proposal for a regulation Article 6 – paragraph 1 1. When preparing national prevention, preparedness and response plans each
Amendment 327 #
Proposal for a regulation Article 6 – paragraph 1 a (new) 1 a. National prevention, preparedness and response plans shall include arrangements for governance, capacities and resources referred to in Article 5(3).
Amendment 328 #
Proposal for a regulation Article 7 – title Reporting on prevention, preparedness and response planning
Amendment 329 #
Proposal for a regulation Article 7 – title Reporting on prevention, preparedness and response planning
Amendment 330 #
Proposal for a regulation Article 7 – paragraph 1 – introductory part 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 and, where appropriate, regional and cross-border levels.
Amendment 331 #
Proposal for a regulation Article 7 – paragraph 1 – introductory part 1. Member States shall
Amendment 332 #
Proposal for a regulation Article 7 – paragraph 1 – introductory part 1. Member States shall by the end of November 2021 and every
Amendment 333 #
Proposal for a regulation Article 7 – paragraph 1 – introductory part 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 and regional level.
Amendment 334 #
Proposal for a regulation Article 7 – paragraph 1 – introductory part 1. Member States shall by the end of November 2021 and every 2 years thereafter provide the Commission with a report on their prevention, preparedness and response
Amendment 335 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – introductory part That report shall be succinct and give an overview of the actions implemented in the Member States, and shall cover the following:
Amendment 336 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – introductory part That report shall be based on set indicators and cover the following:
Amendment 337 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point a (a) identification of, and update, where necessary, on the status of the implementation of the capacity standards for prevent, preparedness and
Amendment 338 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point a (a) identification of, and update on the status of the implementation of the capacity standards for preparedness and response planning as determined at national and regional level for the health sector, as provided to the WHO in accordance with the IHR;
Amendment 339 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point a (
Amendment 340 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – introductory part (b) an update, if needed, on the elements of emergency prevention, preparedness and response, in particular:
Amendment 341 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point i (i) governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery at national and, where relevant, regional and cross-border levels; coordination mechanisms;
Amendment 342 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point i (i) governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery; continuity of critical long-term healthcare; coordination mechanisms;
Amendment 343 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point i (i) governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery; continuity of critical long-term care; coordination mechanisms;
Amendment 344 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point i (i) governance: including national and, if appropriate, regional policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery; coordination mechanisms;
Amendment 345 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point i (i) governance: including national policies and legislation that integrate emergency prevention and preparedness; plans for emergency prevention, preparedness, response and recovery; coordination mechanisms;
Amendment 346 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point i (i) governance: including national policies and legislation that integrate emergency preparedness; plans for emergency preparedness, response and recovery; coordination mechanisms of the competent authorities;
Amendment 347 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point i a (new) (i a) strategic stockpile: including information on the volumes and availability of medical countermeasures and other essential medical products and devices, which shall be limited to those provided by accredited medical suppliers included in the European register referred to in Article 14 paragraph 2, as well as on the capacity for their safekeeping and storage.
Amendment 348 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point ii (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management;
Amendment 349 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point ii (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance
Amendment 350 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point ii (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; details on the exiting national stockpile of medical countermeasures held by supply chain distributors; and access to diagnostic services during emergencies; basic and safe gender-
Amendment 351 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point ii (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, adequate stock of personal protective equipment of the highest quality;
Amendment 352 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point ii (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; existing national stockpile of medical countermeasures; access to diagnostic services during emergencies; basic and safe gender-
Amendment 353 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point ii (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 that take account of the needs of populations with higher risks; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 354 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point ii (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; continuity of critical long-term healthcare; risk communications; research development and evaluations to inform and accelerate emergency preparedness;
Amendment 355 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point ii (ii) capacities: including assessments of risks and capacities to determine priorities for emergency preparedness; surveillance and early warning, information management; equitable access to diagnostic services during emergencies; equitable, quality, basic and safe gender- sensitive health and emergency services; risk communications; research development and evaluations to inform and accelerate emergency preparedness and response;
Amendment 356 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point ii (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
Amendment 357 #
(iii) resources: including financial resources for emergency preparedness and contingency funding for response; health logistics mechanisms
Amendment 358 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point iii (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; and adequate needs-oriented number of dedicated, trained and equipped human resources for emergencies in the health and social services ; and
Amendment 359 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point iii (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistics mechanisms and essential supplies for health; a reserve of critical medical products at Member State level; and dedicated, trained and equipped human resources for emergencies; and
Amendment 360 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point iii (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; continuity of critical long-term healthcare; and
Amendment 361 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point iii (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 continuity of critical long-term care; and
Amendment 362 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point iii (iii) resources: including financial resources for emergency preparedness and contingency funding for response; logistic
Amendment 363 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point b – point iii a (new) (iii a) pandemic stockpile/strategic stockpile: each State shall provide information on the number and availability of medical countermeasures and other essential medicines and medical devices for the control of the threats set out in Article2(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 and centres closest and most accessible to the population centres, which meet the necessary requirements to provide the service in accordance with the regulations applicable to medicinal products, medical devices and other medical countermeasures.
Amendment 364 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point c (c) implementation of national response plans, including where relevant implementation at the regional and local levels, covering epidemic response; antimicrobial resistance, health care associated infection, mental health impacts, the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions, and other specific issues.
Amendment 365 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point c (c) implementation of national and regional response plans, including where relevant implementation at the regional and local levels, covering epidemic response; antimicrobial resistance, health care associated infection, mental health, and other specific issues.
Amendment 366 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point c a (new) (c a) the consultation with social 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 prevailing labour legislation and collective agreements;
Amendment 367 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 1 – point c a (new) (c a) update, if needed, on the gaps found in the implementation and the corrective actions that will be taken by the Member States to improve their preparedness and response capacity.
Amendment 368 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 2 The report shall include, whenever relevant, interregional preparedness and
Amendment 369 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 2 Amendment 370 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 2 The report shall include, whenever relevant, interregional and intersectorial 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.
Amendment 371 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 2 The report shall include, whenever relevant, interregional preparedness and response elements in line with the Union and national and regional plans, covering in particular the existing capacities, resources and coordination mechanisms across neighbouring regions.
Amendment 372 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 2 The report shall include, whenever relevant, interregional prevention, 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.
Amendment 373 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 2 a (new) The report shall also include, as far as feasible, information on major non- communicable diseases as referred to in Article 2 - paragraph 1 - point 4a (new) [ECDC regulation, correct reference to be inserted], in particular those whose developments and treatments are impacted significantly by pandemics, such as cancer, diabetes or mental illness
Amendment 374 #
Proposal for a regulation Article 7 – paragraph 1 – subparagraph 2 a (new) The latest available version of the prevention, preparedness and response plan shall be attached to the report.
Amendment 375 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 1 The report shall include country profiles for monitoring progress and developing action plans to address identified gaps at national and regional level.
Amendment 376 #
Proposal for a regulation Article 7 – paragraph 2 – subparagraph 3 The recommendations of the report shall be published on
Amendment 377 #
Proposal for a regulation Article 7 – paragraph 5 a (new) 5 a. The notification platform shall use the distributed ledger technology (DLT) and include data from national and regional competent authorities and shall be linked to the Health data space.
Amendment 378 #
Proposal for a regulation Article 8 – title Auditing on prevention, preparedness and response planning
Amendment 379 #
Proposal for a regulation Article 8 – title Auditing on prevention, preparedness and response planning
Amendment 380 #
Proposal for a regulation Article 8 – title Amendment 381 #
Proposal for a regulation Article 8 – paragraph 1 1. Every
Amendment 382 #
Proposal for a regulation Article 8 – paragraph 1 1. Every 3 years, the ECDC shall conduct
Amendment 383 #
Proposal for a regulation Article 8 – paragraph 1 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 in cooperation 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).
Amendment 384 #
Proposal for a regulation Article 8 – paragraph 1 1. Every 3 years, the ECDC shall conduct audits in the Member States aimed at ascertaining the state of implementation of the national and regional 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).
Amendment 385 #
Proposal for a regulation Article 8 – paragraph 1 1. Every 3 years, the ECDC shall conduct audits in the Member States aimed
Amendment 386 #
Proposal for a regulation Article 8 – paragraph 2 – introductory part 2. Should the audit identifies deficiencies, the Member State
Amendment 387 #
Proposal for a regulation Article 8 – paragraph 2 – subparagraph 1 – point b (b) initiatives in relation to recruitment and retention of healthcare personnel and training initiatives;
Amendment 388 #
Proposal for a regulation Article 8 – paragraph 2 – subparagraph 1 – point c (c) overview reports of audits
Amendment 389 #
Proposal for a regulation Article 8 – paragraph 2 – subparagraph 1 – point c (c) overview reports
Amendment 390 #
Proposal for a regulation Article 8 – paragraph 2 – subparagraph 1 a (new) If a Member States decides not to follow the recommendation, it shall state reasons for doing so.
Amendment 391 #
Proposal for a regulation Article 9 – title Commission report on prevention, preparedness planning
Amendment 392 #
Proposal for a regulation Article 9 – paragraph 1 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
Amendment 393 #
Proposal for a regulation Article 9 – paragraph 1 1. On the basis of the information provided by the Member States in
Amendment 394 #
Proposal for a regulation Article 9 – paragraph 1 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 395 #
Proposal for a regulation Article 9 – paragraph 1 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
Amendment 396 #
Proposal for a regulation Article 9 – paragraph 1 a (new) 1 a. The Commission report shall include the state of cross-border preparedness and response planning in neighbouring regions.
Amendment 397 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission may adopt recommendations on preparedness and response planning addressed to Member States based on the report referred to in paragraph 1. These recommendations shall include recommendations on the minimum resources needed in relation to population size, developed on the basis of good practice and policy assessments.
Amendment 398 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission may adopt recommendations on preparedness and response planning addressed to Member States based on the report referred to in paragraph 1.These recommendations shall include ratios for resources per population unit, developed on the basis of good practice and policy assessments.
Amendment 399 #
Proposal for a regulation Article 9 – paragraph 2 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.
Amendment 400 #
Coordination of prevention, preparedness and response planning in the HSC
Amendment 401 #
Proposal for a regulation Article 10 – title Coordination of prevention, preparedness and response planning in the HSC
Amendment 402 #
Proposal for a regulation Article 10 – paragraph 1 – introductory part 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, early warning and assessment of, and response to serious cross-border threats to health.
Amendment 403 #
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, prevention, early warning, and assessment of, and response to serious cross-border threats to health.
Amendment 404 #
Proposal for a regulation Article 10 – paragraph 1 – introductory part 1. The Commission and the Member States shall work together within the HSC to coordinate their efforts to develop, strengthen
Amendment 405 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 – point a (a) sharing best practice and experience in prevention, preparedness and response planning;
Amendment 406 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 – point b (b) promoting the interoperability of national prevention, preparedness planning and the intersectoral dimension of prevention, preparedness and response planning at Union level;
Amendment 407 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 – point b (b) promoting the interoperability of national and regional preparedness planning and the intersectoral dimension of preparedness and response planning at Union level;
Amendment 408 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 – point c (
Amendment 409 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 – point d (d)
Amendment 410 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 – point e (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 411 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 – point e (e) monitoring progress, identifying gaps and actions to strengthen prevention, preparedness and response planning, including in the field of research, at
Amendment 412 #
Proposal for a regulation Article 10 – paragraph 1 – subparagraph 1 – point e (e) monitoring progress, identifying gaps and actions to strengthen preparedness and response planning, including in the field of research, at national, regional and at Union levels.
Amendment 413 #
Proposal for a regulation Article 10 – paragraph 1 – point 1 (new) (1) Regular two-way communication and exchange of information between authorities, industry and relevant entities of the pharmaceutical supply chain shall also be ensured to start early discussions about expected potential serious cross- border threats to health in the market by way of sharing expected supply constraints, allowing better coordination, synergies and appropriate reaction when relevant;
Amendment 414 #
Proposal for a regulation Article 10 – paragraph 1 a (new) 1 a. The Commission and the Member States shall, where relevant, conduct a dialogue with relevant stakeholders, including health and care workers organizations, industry and supply chain stakeholders, and patients organizations;
Amendment 415 #
Proposal for a regulation Article 11 – paragraph 1 – introductory part 1. The Commission may organise training activities, supported by the Union agencies including ECDC, EMA among others, in close cooperation with medical societies and patient organisations, for healthcare staff and public health staff in the Member States in particular interdisciplinary One Health training, including preparedness capacities under the International Health Regulations.
Amendment 416 #
Proposal for a regulation Article 11 – paragraph 1 – introductory part 1. The Commission or relevant Union agencies may organise training activities for healthcare staff and public health staff in the Member States, including preparedness capacities under the International Health Regulations.
Amendment 417 #
Proposal for a regulation Article 11 – paragraph 1 – introductory part 1. The Commission may organise training activities for healthcare and social service staff and public health staff in the Member States, including preparedness capacities under the International Health Regulations.
Amendment 418 #
Proposal for a regulation Article 11 – paragraph 1 – introductory part Amendment 419 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 The Commission shall organise those activities in cooperation with the Member States concerned and in articulation with WHO to avoid duplication of activities, including preparedness capacities under the International Health Regulations. At border regions, joint cross-border exercises should be promoted and familiarity with public health systems encouraged.
Amendment 420 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 The Commission shall organise those activities in cooperation with the Member States concerned or potentially concerned. In cross-border regions, mandatory joint cross-border training and sharing of best practices for healthcare staff and public health staff shall be organised.
Amendment 421 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 The Commission shall organise those activities in cooperation with the Member States concerned. At border regions, joint cross-border exercises should be promoted and familiarity with public health systems encouraged.
Amendment 422 #
Proposal for a regulation Article 11 – paragraph 1 – subparagraph 1 a (new) The Commission shall use the fullest potential of distance learning to broaden the number of trainees.
Amendment 423 #
Proposal for a regulation Article 11 – paragraph 2 2. The training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national preparedness plans referred to in Article 6, implement activities to strengthen crisis preparedness and
Amendment 424 #
Proposal for a regulation Article 11 – paragraph 2 2. The training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national preparedness plans referred to in Article 6, implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools, and to ensure the continuity of critical long-term healthcare services.
Amendment 425 #
Proposal for a regulation Article 11 – paragraph 2 2. The training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national preparedness plans referred to in Article 6, implement activities to strengthen crisis preparedness and
Amendment 426 #
Proposal for a regulation Article 11 – paragraph 2 2. The training activities referred to in paragraph 1 shall aim to provide staff referred to in that paragraph with knowledge and skills necessary in particular to develop and implement the national and regional preparedness plans referred to in Article 6, implement activities to strengthen crisis preparedness and surveillance capacities including the use of digital tools.
Amendment 427 #
Proposal for a regulation Article 11 – paragraph 2 a (new) 2 a. The knowledge and skills referred to in paragraph 2 should be updated every 3 years at the latest, with activities, including laboratory staff training, that fit the needs of healthcare staff and public health staff.
Amendment 428 #
Proposal for a regulation Article 11 – paragraph 3 3. The training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may be organised outside the Union in coordination with ECDC activities in this area.
Amendment 429 #
Proposal for a regulation Article 11 – paragraph 3 3. The training activities referred to in paragraph 1 may be open to staff of the competent authorities of third countries and may, in justified cases, be organised outside the Union.
Amendment 430 #
Proposal for a regulation Article 11 – paragraph 5 5. The Commission may support organising programmes, in cooperation with the Member States, for the exchange of healthcare staff and public health staff between two or more Member States and
Amendment 431 #
Proposal for a regulation Article 12 – paragraph 1 1. The Commission and any Member States which so desire may engage in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health during extraordinary emergencies such as future pandemics, where purchase and supply of products cannot be ensured as efficiently by other means. _________________ 29Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).
Amendment 432 #
Proposal for a regulation Article 12 – paragraph 1 1.
Amendment 433 #
Proposal for a regulation Article 12 – paragraph 1 1. The Commission and any Member
Amendment 434 #
Proposal for a regulation Article 12 – paragraph 1 1. The Commission and any Member States which so desire may engage in a joint procurement procedure as contracting parties conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council29 with a view to the advance purchase of medical countermeasures for serious cross-border threats to health. _________________ 29Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the
Amendment 435 #
Proposal for a regulation Article 12 – paragraph 1 1. The Commission and any Member States which so desire may engage in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council29 with a view to the advance purchase of
Amendment 436 #
Proposal for a regulation Article 12 – paragraph 2 – point a (a) participation in the joint procurement procedure shall be open to all Members States, European Free Trade Association (EFTA) States
Amendment 437 #
Proposal for a regulation Article 12 – paragraph 2 – point a a (new) (a a) by way of derogation from Article 165(2) of Regulation (EU, Euratom) 2018/1046, the Commission shall put in place all the necessary measures to extend the participation in the joint procurement procedure to those third Countries whose territories lie entirely within a Member State.
Amendment 438 #
Proposal for a regulation Article 12 – paragraph 2 – point a a (new) (a a) The purpose of joint procurement should be to guarantee stability inan unpredictable environment during a serious cross-border threat to health only. In other circumstances, other measures shall be privileged, such as procurement at national level;
Amendment 439 #
Proposal for a regulation Article 12 – paragraph 2 – point b a (new) (b a) the joint procurement shall be carried in accordance with the Directive 2014/24/EU in a transparent manner;and should respect the following: 1.The procurement process, criteria, timelines, specifications, and formalities must be transparent and workable; 2.A preliminary consultation phase involving potential participating manufacturers must take place; 3.Ensure clear volume commitments irrespective of the selected supply modality; 4.Participating countries need to commit not to procure the same medicines via other means and must honour pre- existing supply contracts with manufacturers; 5.Joint procurement lead times must be aligned with manufacturing processes lead times; 6.National authorities should apply certain regulatory flexibilities; 7. Award criteria other than price should be defined.
Amendment 440 #
Proposal for a regulation Article 12 – paragraph 2 – point b a (new) (b a) The Joint procurement shall be carried ina transparent, timely and effective way defining clear steps since the beginning of the procedure in terms of process, scope, tender specifications, timeline sand formalities. A preliminary consultation phase involving participating actors shall be guaranteed, as well as a two-way communication throughout the whole procedure;
Amendment 441 #
Proposal for a regulation Article 12 – paragraph 2 – point c (c) Member States, EFTA States and Union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels, and shall not run parallel negotiation processes for that product. Member States that run parallel negotiation processes, having reached the signature or not of such processes, shall be excluded from the group of participating countries;
Amendment 442 #
Proposal for a regulation Article 12 – paragraph 2 – point c (c) Member States, EFTA States and Union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels, and shall not run parallel negotiation processes for that product. In addition, joint procurement shall not exempt participating countries from honouring existing contractual agreements nor shall replace countries regular procurement processes;
Amendment 443 #
Proposal for a regulation Article 12 – paragraph 2 – point c (c) Member States, EFTA States and Union candidate countries participating in a joint procurement shall procure the medical countermeasure in question through that procedure and not through other channels, and shall not run parallel negotiation processes for that product, and this shall not impact pre-existing contractual agreements with suppliers of medical countermeasures;
Amendment 444 #
Proposal for a regulation Article 12 – paragraph 2 – point c (c) Member States, EFTA States
Amendment 445 #
Proposal for a regulation Article 12 – paragraph 2 – point c (c)
Amendment 446 #
Proposal for a regulation Article 12 – paragraph 2 – point c a (new) Amendment 447 #
Proposal for a regulation Article 12 – paragraph 2 – point c a (new) (c a) The joint procurement lead times shall be aligned with manufacturers lead times;
Amendment 448 #
Proposal for a regulation Article 12 – paragraph 2 – point c b (new) (c b) the joint procurement shall be conducted in such a way so as to strengthen the purchasing power of participating countries, improve the security of supply and ensure equitable access to medical countermeasures against serious cross-border threats to health;
Amendment 449 #
Proposal for a regulation Article 12 – paragraph 2 – point c b (new) (c b) Commitments should be defined and respected by all parties involved from manufacturers, supply chain stakeholders and authorities;
Amendment 450 #
Proposal for a regulation Article 12 – paragraph 2 – point d (d) the joint procurement shall not affect the internal market, shall not constitute discrimination or a restriction of trade and shall not cause distortion of competition, nor replace exiting procurement procedures implemented by participating countries;
Amendment 451 #
Proposal for a regulation Article 12 – paragraph 2 – point d (d) the joint procurement shall not affect the internal market, shall not constitute discrimination or a restriction of trade and shall not cause distortion of competition, nor replace existing procurement procedures implemented by participating countries;
Amendment 452 #
Proposal for a regulation Article 12 – paragraph 2 – point d a (new) (d a) Joint procurement shall be based on shared responsibilities and a fair approach for all parties involved, both relevant authorities and manufacturers. Clear commitments shall be ensured and respected for all parties involved, from the manufacturers to deliver on the production, and from the authorities to purchase their agreed reserved volumes;
Amendment 453 #
Proposal for a regulation Article 12 – paragraph 2 – point d a (new) (d a) The functioning of the Joint Procurement Agreement should abide by high standards of transparency, including in relation to the disclosure of the exact amount ordered and provided to each participating country, and delivery of procured products, and details of the liability of participating countries;
Amendment 454 #
Proposal for a regulation Article 12 – paragraph 2 – point d a (new) (d a) a high degree of transparency shall be applied to all joint procurement activities and related purchase agreements; The European Court of Auditors shall have full access to all relevant documents to provide accurate annual scrutiny of signed contracts and public investment;
Amendment 455 #
Proposal for a regulation Article 12 – paragraph 2 – point d a (new) (d a) qualitative criteria shall be defined and be considered in the awarding process of the joint procurement bids, in addition to the lowest price;
Amendment 456 #
Proposal for a regulation Article 12 – paragraph 2 – point d b (new) Amendment 457 #
Proposal for a regulation Article 12 – paragraph 2 – point d b (new) (d b) regulatory flexibility should be considered and allowed to ensure faster supply to the markets of the different Member States, for example by accepting each other Marketing Authorizations in case of emergencies;
Amendment 458 #
Proposal for a regulation Article 12 – paragraph 2 – point d c (new) (d c) if joint deployment is deployed, qualitative criteria shall also be considered in the awarding process in addition to cost. Such criteria shall also take into consideration, for example, the ability of the manufacturer to ensure security of supply during a health crisis;
Amendment 459 #
Proposal for a regulation Article 12 – paragraph 2 – point e a (new) (ea) the joint procedure must guarantee the application of the most economically advantageous tender criteria, but should look beyond the lowest price criterion; investments in the manufacture of active ingredients and medicinal end products in the EU should also be retained as a criterion, as well as the number and location of production sites, the reliability of supply, the reinvestment of profits into R&D and the application of social, environmental, ethical and quality standards;
Amendment 460 #
Proposal for a regulation Article 12 – paragraph 2 – point e a (new) (e a) the joint procurement shall not risk impacting supply flows negatively by increasing the risk of shortages in the EU or third countries, jeopardise product choice, or create market distortion or any concentration of demand, and shall therefore be time-limited to the emergency situation;
Amendment 461 #
Proposal for a regulation Article 12 – paragraph 2 – subparagraph 1 (new) Member States joining a joint procurement may change the demand expressed earlier, including resignation from participation in the procurement, if there has been a significant change in circumstances resulting from a legitimate public interest.
Amendment 462 #
Proposal for a regulation Article 12 – paragraph 2 a (new) 2 a. the joint procurement shall not negatively affect supply flows, risk increasing shortages or jeopardise product choice;
Amendment 463 #
Proposal for a regulation Article 12 – paragraph 3 – introductory part 3. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the entities organizing any action, including, but not limited to joint procurement procedures, stockpiling in facilities that meet the specific legal requirements for the storage of medical countermeasures and with the greatest proximity and accessibility to the greatest number of population centres and donation of medical countermeasures under different mechanisms established at Union level, in particular under:
Amendment 464 #
Proposal for a regulation Article 12 – paragraph 3 – introductory part 3. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the entities organizing an
Amendment 465 #
Proposal for a regulation Article 12 – paragraph 3 – introductory part 3. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the entities organizing and participating in any action, including, but not limited to joint procurement procedures, stockpiling and donation of medical countermeasures under different mechanisms established at Union level, in particular under:
Amendment 466 #
Proposal for a regulation Article 12 – paragraph 3 – introductory part 3.
Amendment 467 #
Proposal for a regulation Article 12 – paragraph 3 – introductory part 3. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the entities organizing and participating in any action, including, but not limited to joint procurement procedures, stockpiling and donation of medical countermeasures under different mechanisms established at Union level, in particular under:
Amendment 468 #
Proposal for a regulation Article 12 – paragraph 3 – point a (a) stockpiling under the rescEU referred to in Article
Amendment 469 #
Proposal for a regulation Article 12 – paragraph 3 – point f – point i (new) i) The purpose of joint procurement should be to guarantee stability in an unpredictable environment during a serious cross-border threat to health only.In other circumstances, other measures shall be privileged, such as procurement at national level; The joint procurement shall be carried in a transparent, timely and effective way defining clear steps since the beginning of the procedure in terms of process, scope, tender specifications, timelines and formalities;
Amendment 470 #
Proposal for a regulation Article 12 – paragraph 3 a (new) 3 a. The Commission must ensure all joint procurement contracts are made available to the public and accessible on Commission’s website within 30 days after signing of the contract.Information disclosed for public scrutiny shall include: (a) the amount of public investment paid to the contractor, broke down by cost structure of the product; (b) price per unit of the product; (c) number of product units to be delivered per quarter; (d) number and locations of the product’s manufacturing sites; (e) arrangements related to product donations, intellectual property and technology transfer within the Union and with third countries; (f) product liability clauses and compensation for any damage caused by the product; (g) terms and conditions related to the breach of the contracts and their termination.
Amendment 471 #
Proposal for a regulation Article 12 – paragraph 3 a (new) 3 a. The Commission shall adopt recommendations to Member States on the joint procurement procedures and minimum quantities of medical devices, medicines, therapeutics and personal protective equipment needed and update such recommendations, where relevant. The Commission shall supervise the sufficiency of the stocks at Member State level and provide guidance to Member States thereon.
Amendment 472 #
Proposal for a regulation Article 12 – paragraph 3 a (new) 3 a. The Union shall strive to also support access to counter-measures for Eastern Partnership and low- and middle- income countries.
Amendment 473 #
Proposal for a regulation Article 12 – paragraph 3 b (new) 3 b. Joint procurement contracts for medical countermeasures essential for the mitigation of the duration of the health threat and wellbeing of populations, including vaccines and other medicinal products and medical devices. The contract shall include clauses according to which the suppliers shall make freely available the technologies, know-how and trade secrets underpinning the above- mentioned products under global non- exclusive licences on reasonable terms. Those licences shall be made available to patent pools and other multilateral technology transfers mechanisms aiming at disseminating innovations and scaling-up global production of these products.
Amendment 474 #
Proposal for a regulation Article 13 – paragraph 1 1. The network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1) shall ensure a permanent communication between the Commission, the ECDC,
Amendment 475 #
Proposal for a regulation Article 13 – paragraph 1 1. The network for the epidemiological surveillance of the communicable diseases, including communicable diseases of zoonotic origin, and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1) shall ensure a permanent communication between the Commission, the ECDC, and the competent authorities responsible at national level for epidemiological surveillance.
Amendment 476 #
Proposal for a regulation Article 13 – paragraph 1 1. The network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1) shall ensure a permanent communication between the Commission, the ECDC, the EMA and the competent authorities responsible at national, and where applicable regional, level for epidemiological surveillance.
Amendment 477 #
Proposal for a regulation Article 13 – paragraph 2 – point b (b) detect and monitor any multinational communicable disease outbreaks with respect to source, time, population and place in order to provide a rationale for public health action, as well as its impact on non-communicable diseases or health consequences like mental health conditions;
Amendment 478 #
Proposal for a regulation Article 13 – paragraph 2 – point b a (new) (b a) monitor the impact of communicable diseases on the continuity of screening, diagnosis, monitoring, treatment and care for other diseases and conditions;
Amendment 479 #
Proposal for a regulation Article 13 – paragraph 2 – point b b (new) (b b) monitor the impact of communicable diseases on mental health;
Amendment 480 #
Proposal for a regulation Article 13 – paragraph 2 – point c (c) contribute to the evaluation and monitoring of communicable disease prevention and control programmes in order to provide the evidence for recommendations to strengthen and improve those programmes at the national
Amendment 481 #
Proposal for a regulation Article 13 – paragraph 2 – point d (d) identify and monitor risk factors for disease transmission, population groups at risk and in need of targeted prevention measures;
Amendment 482 #
Proposal for a regulation Article 13 – paragraph 2 – point e (e) contribute to the assessment of the burden of communicable diseases on the population using such data as disease prevalence, complications, hospitalisation and mortality, the mental health impact and deferred screening, diagnosis, monitoring, treatment and care for other diseases and conditions;
Amendment 483 #
(e) contribute to the assessment of the burden of communicable diseases on health systems, care delivery, including for non-communicable diseases (NCDs), and the population using such data as disease prevalence, complications, hospitalisation and mortality;
Amendment 484 #
Proposal for a regulation Article 13 – paragraph 2 – point e (e) contribute to the assessment of the burden of communicable diseases on the population using such data as disease prevalence, complications, the need for hospitalisation and mortality;
Amendment 485 #
Proposal for a regulation Article 13 – paragraph 2 – point h (h) identify research priorities and needs, and implement relevant research activities with the aim of anticipating future health hazards;
Amendment 486 #
Proposal for a regulation Article 13 – paragraph 2 – point h a (new) (h a) identify any weakness in the global supply chain involved in the production and manufacturing of medical countermeasures needed for the prevention, diagnosis, treatment and follow up of communicable diseases;
Amendment 487 #
Proposal for a regulation Article 13 – paragraph 2 – point h a (new) (h a) make mitigation plans containing preventative measures that help ensure the continued supply of critical medicines, such as diversification of supply chains, as well as including production and supply capacity;
Amendment 488 #
Proposal for a regulation Article 13 – paragraph 2 – point i a (new) Amendment 489 #
Proposal for a regulation Article 13 – paragraph 2 – point i a (new) (i a) contribute to the improvement of coordinated surveillance at the different levels of care, enhancing common working models for all health professionals and enhancing their involvement, including through the collaboration of health professional organisations.
Amendment 490 #
Proposal for a regulation Article 13 – paragraph 3 – introductory part 3. The national and regional competent authorities referred to in paragraph 1 shall communicate the following information to the participating authorities of the epidemiological surveillance network:
Amendment 491 #
Proposal for a regulation Article 13 – paragraph 3 – introductory part 3. The national competent authorities referred to in paragraph 1 shall
Amendment 492 #
Proposal for a regulation Article 13 – paragraph 3 – point b (b) relevant information concerning the progression of epidemic situations, including for modelling and scenario development, for response;
Amendment 493 #
Proposal for a regulation Article 13 – paragraph 3 – point f (f) information about contract tracing monitoring systems developed at national and regional level.
Amendment 494 #
Proposal for a regulation Article 13 – paragraph 3 – point f a (new) (f a) information on the availability of medical countermeasures needed for the prevention, diagnosis, treatment and follow up of the disease.
Amendment 495 #
Proposal for a regulation Article 13 – paragraph 3 a (new) 3 a. The information communicated by Member States referred to in point (a) shall be reported at least at NUTS II level to the European Surveillance System (TESSy) or another platform, on a timely basis defined by the article 9.
Amendment 496 #
Proposal for a regulation Article 13 – paragraph 4 4. When reporting information on epidemiological surveillance, the national and regional competent authorities shall, where available, use the case definitions adopted
Amendment 497 #
Proposal for a regulation Article 13 – paragraph 4 4. When
Amendment 498 #
Proposal for a regulation Article 13 – paragraph 5 5. The Commission and the Member States shall work together to define disease-specific European surveillance standards that may serve as a guide based on the proposal of the ECDC, in consultation with the relevant surveillance networks.
Amendment 499 #
Proposal for a regulation Article 13 – paragraph 5 5. The Commission and the Member States shall work together to define disease-specific European surveillance standards based on the proposal of the ECDC, in consultation with othe
Amendment 500 #
Proposal for a regulation Article 13 – paragraph 6 – subparagraph 1 a (new) The ECDC shall support the Member States to ensure the integrated operation of the network for the epidemiological surveillance of the communicable diseases and of the related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1).
Amendment 501 #
Proposal for a regulation Article 13 – paragraph 9 – introductory part 9. The Commission shall, after consulting with the ECDC, by means of implementing acts, establish and update:
Amendment 502 #
Proposal for a regulation Article 14 – paragraph 1 1. The ECDC shall ensure the further development of the digital platform through which data are managed and automatically exchanged, to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, and to regularly monitor information on medical countermeasures available in the EU in collaboration with the Member States, for the purpose of supporting communicable disease prevention and control.
Amendment 503 #
Proposal for a regulation Article 14 – paragraph 1 1. The ECDC shall ensure the
Amendment 504 #
Proposal for a regulation Article 14 – paragraph 1 1. The ECDC shall ensure the further development of the digital platform through which data are managed and automatically exchanged, to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, for the purpose of supporting communicable disease prevention and control. Human oversight should be ensured.
Amendment 505 #
Proposal for a regulation Article 14 – paragraph 1 1. The ECDC shall ensure the further development of the digital platform through which data are managed and automatically exchanged, to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, for the purpose of supporting communicable disease prevention and control. Human oversight should be ensured.
Amendment 506 #
Proposal for a regulation Article 14 – paragraph 1 1. The ECDC shall ensure the further development of the digital platform through which data are managed and automatically exchanged, to establish integrated and interoperable surveillance systems enabling real-time surveillance where appropriate, for the purpose of supporting communicable disease prevention and control. Human oversight should be ensured.
Amendment 507 #
Proposal for a regulation Article 14 – paragraph 1 1. The ECDC shall ensure the further development of the digital platform through which data are managed and automatically exchanged, to establish an integrated and interoperable surveillance system
Amendment 508 #
Proposal for a regulation Article 14 – paragraph 2 – point a (a) enable the automated collection of surveillance and laboratory data, make use of
Amendment 509 #
Proposal for a regulation Article 14 – paragraph 2 – point a (a) enable the automated collection of surveillance and laboratory data, make use of information from electronic health records, media monitoring, and apply artificial intelligence for data validation, analysis and
Amendment 510 #
Proposal for a regulation Article 14 – paragraph 2 – point b a (new) (b a) include specific measures for minimising risks that may emerge from the transfer of bias or incomplete data from multiple sources, as well as establish procedures for data quality review to provide quality assurance of surveillance activities.
Amendment 511 #
Proposal for a regulation Article 14 – paragraph 2 – point b a (new) (b a) be used as a mechanism through which relevant third-party stakeholders, including marketing authorisation holders, are made aware, in a timely fashion, of epidemiological data, modelling and response scenarios developed by EU authorities.
Amendment 512 #
Proposal for a regulation Article 14 – paragraph 2 – point b a (new) (b a) allow for automated notification on EWRS when communicable diseases rise above warning thresholds, as referred to in point (a) of article 13(2). The notification shall be validated by the competent health authority.
Amendment 513 #
Proposal for a regulation Article 14 – paragraph 3 3. Member States are responsible for ensuring that the integrated surveillance system is fed on a regular basis with timely and complete information, data and documents transmitted and exchanged through the digital platform. The Member States shall promote the automation of this process between the national and the Union surveillance system.
Amendment 514 #
Proposal for a regulation Article 14 – paragraph 5 5. For epidemiological surveillance purposes, ECDC shall also have access to relevant health data accessed or made available through digital infrastructures enabling the use of health data for research, policy making and regulatory purposes. The access to the health data should be proportionate to specific and concrete purposes that shall be defined previously by ECDC.
Amendment 515 #
Proposal for a regulation Article 14 – paragraph 6 – point c (c) contingency arrangements and secure data backups to be applied in the event of unavailability of any of the functionalities of the platform;
Amendment 516 #
Proposal for a regulation Article 14 – paragraph 6 – point f a (new) (f a) Ensure standardization of the infrastructure on storage, processing and analysis of data.
Amendment 517 #
Proposal for a regulation Article 14 – paragraph 6 a (new) 6 a. Digital platforms and applications supporting epidemiological surveillance at Union and Member State level shall be implemented with in compliance with the principle of data protection by design pursuant to Art. 27(1) of Regulation (EU) 2018/1725.
Amendment 518 #
Proposal for a regulation Article 14 – paragraph 6 a (new) 6 a. The surveillance platform shall use the distributed ledger technology (DLT) and include data from national and regional competent authorities and shall be linked to the health data space where possible.
Amendment 519 #
Proposal for a regulation Article 15 – paragraph 1 1. In the area of public health or for specific areas of public health relevant for the implementation of this Regulation or of the national and regional plans referred to in Article 6, the Commission may, by means of implementing acts, designate EU reference laboratories to provide support to national and regional reference laboratories to promote good practice and alignment by Member States on a voluntary basis on diagnostics, testing methods, use of certain tests for the uniform surveillance, notification and reporting of diseases by Member States.
Amendment 520 #
Proposal for a regulation Article 15 – paragraph 1 1. In the area of public health or for specific areas of public health relevant for the implementation of this Regulation or of the national plans referred to in Article 6, the Commission may, by means of implementing acts, designate EU reference laboratories to provide support to national reference laboratories to promote good practice and alignment by Member States on
Amendment 521 #
Proposal for a regulation Article 15 – paragraph 2 – introductory part 2. The EU reference laboratories shall be responsible in particular for the following tasks to coordinate the network of national and regional reference laboratories, in particular, in the following areas:
Amendment 522 #
Proposal for a regulation Article 15 – paragraph 2 – introductory part 2. The EU reference laboratories shall
Amendment 523 #
Proposal for a regulation Article 15 – paragraph 2 – point g (g) training in current and innovative research procedures and skills.
Amendment 524 #
Proposal for a regulation Article 15 – paragraph 2 – point g a (new) (g a) obtaining, recording and sharing information about innovative medicinal products, devices, applications or developments that are still not harmonised throughout the Union, such as plasma- derived products;
Amendment 525 #
Proposal for a regulation Article 15 – paragraph 3 3. The network of EU reference
Amendment 526 #
Proposal for a regulation Article 15 – paragraph 3 3. The network of EU reference laboratories shall be operated and coordinated by the ECDC in cooperation with WHO network laboratories to avoid duplication of activities.
Amendment 527 #
Proposal for a regulation Article 15 – paragraph 3 Amendment 528 #
Proposal for a regulation Article 15 – paragraph 3 a (new) 3 a. The laboratories referred to in paragraph 1 should contribute to share good practices and to improve the epidemiological surveillance referred to in article 13;
Amendment 529 #
Proposal for a regulation Article 15 – paragraph 4 – introductory part 4. The designations provided for in paragraph 1 shall follow a public selection process, be limited in time, with a minimum period of 5 years, and be reviewed regularly. Designations shall establish the responsibilities and tasks of the designated laboratories. Groups or coalitions of laboratories shall also be eligible for such designation.
Amendment 530 #
Proposal for a regulation Article 15 – paragraph 4 – introductory part Amendment 531 #
Proposal for a regulation Article 15 – paragraph 6 Amendment 532 #
Proposal for a regulation Article 16 – paragraph 1 1. A network of Member States’ services supporting transfusion
Amendment 533 #
Proposal for a regulation Article 16 – paragraph 1 a (new) 1 a. The network shall share information on developments that are still not harmonised throughout the Union, such as plasma-derived products.
Amendment 534 #
Proposal for a regulation Article 16 – paragraph 2 2. The
Amendment 535 #
Proposal for a regulation Article 16 – paragraph 3 3.
Amendment 536 #
Proposal for a regulation Article 16 – paragraph 3 3. Each Member State shall designate the competent authorities responsible within their territory for the services supporting transfusion
Amendment 537 #
Proposal for a regulation Article 16 – paragraph 3 a (new) 3 a. The sero-epidemiological data referred to in paragraph 1 shall be reported automatically to the national surveillance platforms, contributing to robust the monitoring and epidemiological surveillance of communicable diseases and related special health issues referred to in points (i) and (ii) of point (a) of Article 2(1);
Amendment 538 #
Proposal for a regulation Article 16 – paragraph 3 b (new) 3 b. The network shall establish Union common standards for transfusion, transplantation and medically assisted reproduction services.
Amendment 539 #
Proposal for a regulation Article 16 a (new) Amendment 540 #
Proposal for a regulation Article 17 – paragraph 1 1. Following an alert notified pursuant to Article 19 concerning a serious cross- border threat to health referred to in point (iii) of point (a) of Article 2(1) and in points (b), (c) or (d) of Article 2(1), Member States shall, in liaison with the Commission and on the basis of the available information from their monitoring systems, inform each other through the ‘Early Warning and Response System’ (‘EWRS’) and, if the urgency of the situation so requires, through the HSC about developments with regard to the threat concerned at national and regional level.
Amendment 541 #
Proposal for a regulation Article 17 – paragraph 1 a (new) 1 a. The European Surveillance System (TESSy) shall be used for ad hoc monitoring of a serious cross-border threat to health referred to in point (iii) of point (a) of Article 2(1) and in points (b), (c) or (d) of Article 2(1).
Amendment 542 #
Proposal for a regulation Article 17 – paragraph 3 – introductory part 3. The Commission, after consulting the ECDC shall, by means of implementing acts, adopt, where necessary, the case definitions to be used for ad hoc monitoring, in order to ensure the comparability and compatibility at Union level of the collected data.
Amendment 543 #
Proposal for a regulation Article 18 – paragraph 1 1. The EWRS shall enable the Commission and the competent authorities responsible at national and regional level to be in permanent communication for the purposes of preparedness, early warning and response, alerting, assessing public health risks and determining the measures that may be required to protect public health.
Amendment 544 #
Proposal for a regulation Article 18 – paragraph 1 1. The EWRS shall enable the Commission, the ECDC, and the competent authorities responsible at national level to be in permanent communication for the purposes of preparedness, early warning and response, alerting, assessing public health risks and determining the measures that may be required to protect public health.
Amendment 545 #
Proposal for a regulation Article 18 – paragraph 2 – subparagraph 1 The ECDC shall continuously update the EWRS
Amendment 546 #
Proposal for a regulation Article 18 – paragraph 2 – subparagraph 1 The ECDC shall continuously update the EWRS allowing for the use of modern technologies, such as digital mobile applications,
Amendment 547 #
Proposal for a regulation Article 18 – paragraph 2 – subparagraph 1 The ECDC shall continuously update the EWRS allowing for the use of modern
Amendment 548 #
Proposal for a regulation Article 18 – paragraph 2 – subparagraph 1 The ECDC shall continuously update the EWRS allowing for the use of modern technologies, such as digital mobile applications, artificial intelligence models, space enabled applications, or other technologies for automated contact tracing, building upon the contact tracing technologies developed by the Member States or by the Union.
Amendment 549 #
Proposal for a regulation Article 18 – paragraph 2 – subparagraph 1 a (new) Personal data, including the contact tracing data, should not be kept longer than is necessary to fulfil the purpose for which it was collected; in this regard a maximum retention period of 12 months for contact tracing data shall be respected.
Amendment 550 #
Proposal for a regulation Article 18 – paragraph 2 – subparagraph 1 b (new) Appropriate anonymisation techniques shall be applied to all personal data and the processing shall be restricted to aggregate data that cannot be traced back to individuals as far as possible, with the exception of contact tracing data.
Amendment 551 #
Proposal for a regulation Article 18 – paragraph 2 a (new) 2 a. The EWRS shall establish interoperable databases with Member States, and regions where applicable. The ECDC shall coordinate the data exchange processes, from assessing the data requirement, transmission and collection, up to data updates and processing. The EWRS shall assess the implementation of distributed ledger technology (DLT).
Amendment 552 #
Proposal for a regulation Article 18 – paragraph 2 a (new) 2 a. The ECDC shall develop and improve the EWRS, to augment the automation of information collection and analyses, upgrade the categorization of notification and reduce the open text communication, reduce the administrative burden and improve the standardization of the notifications.
Amendment 553 #
Proposal for a regulation Article 18 – paragraph 2 b (new) 2 b. The EWRS shall be improved to reduce the burden of bureaucracy and duplications of notification and shall allow the national competent authorities notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR and take up this information in the EWRS system, to automatically notify an alert in the EWRS.
Amendment 554 #
Proposal for a regulation Article 18 – paragraph 3 3. Each Member State shall designate the competent authority or authorities responsible at national and regional level for notifying alerts and determining the measures required to protect public health, for the
Amendment 555 #
Proposal for a regulation Article 18 – paragraph 4 a (new) 4 a. The EWRS shall be able to automatically collect information from other important databases such as environmental data, climate data, water irrigation data and other data relevant to the serious cross-border threat to health that could facilitate understanding and mitigate the risk of potential health threats.
Amendment 556 #
Proposal for a regulation Article 19 – paragraph 1 – introductory part 1. National and regional competent authorities or the Commission shall notify an alert in the EWRS where the emergence or development of a serious cross-border threat to health fulfils the following criteria:
Amendment 557 #
Proposal for a regulation Article 19 – paragraph 2 2. Where the national competent authorities notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR, they shall at the latest simultaneously notify an alert in the EWRS, as well as to any directly involved third party stakeholders (such as manufacturers of relevant medical countermeasures), provided that the threat concerned falls within those referred to in Article 2(1) of this Regulation.
Amendment 558 #
Proposal for a regulation Article 19 – paragraph 2 2. Where the national competent authorities notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR,
Amendment 559 #
2. Where the national and regional competent authorities notify the WHO of events that may constitute public health emergencies of international concern in accordance with Article 6 of the IHR, they shall at the latest simultaneously notify an alert in the EWRS, provided that the threat concerned falls within those referred to in Article 2(1) of this Regulation.
Amendment 560 #
Proposal for a regulation Article 19 – paragraph 2 Amendment 561 #
Proposal for a regulation Article 19 – paragraph 3 – introductory part 3. When notifying an alert, the
Amendment 562 #
Proposal for a regulation Article 19 – paragraph 3 – introductory part 3. When notifying an alert, the national and regional competent authorities and the Commission shall promptly communicate through the EWRS any available relevant information in their possession that may be useful for coordinating the response such as:
Amendment 563 #
Proposal for a regulation Article 19 – paragraph 3 – point f (f) public health risks, to the extent feasible including impacts on the major con-communicable diseases;
Amendment 564 #
Proposal for a regulation Article 19 – paragraph 3 – point g (g) public health measures implemented or intended to be taken at national and regional level;
Amendment 565 #
Proposal for a regulation Article 19 – paragraph 3 – point i a (new) (i a) the existing and potential production sites, with the sole aim of allowing the Union to map the strategic production capacities for the Union as a whole;
Amendment 566 #
Proposal for a regulation Article 19 – paragraph 3 – point j (j) requests and offers for cross-border emergency assistance
Amendment 567 #
Proposal for a regulation Article 19 – paragraph 4 4. The Commission shall make available to the national and regional competent authorities through the EWRS any information that may be useful for coordinating the response referred to in Article 21, including information related to serious cross-border threats to health and public health measures related to serious cross-border threats to health already transmitted through rapid alert and information systems established under other provisions of Union law or the Euratom Treaty.
Amendment 568 #
Proposal for a regulation Article 19 – paragraph 4 a (new) 4 a. The Member State shall update the information referred to in paragraph 3 as new data becames available.
Amendment 569 #
Proposal for a regulation Article 20 – paragraph 1 – introductory part 1. Where an alert is notified pursuant to Article 19, the Commission shall, where necessary for the coordination of the response at Union level or upon request of the HSC referred to in Article 21 or on its own initiative, make promptly available to the national competent authorities and to the HSC, through the EWRS, a risk assessment of the potential severity of the threat to public health, including possible public health measures, including a risk assessment of mental health of the affected population. That risk assessment shall be carried out by:
Amendment 570 #
Proposal for a regulation Article 20 – paragraph 1 – introductory part 1. Where an alert is notified pursuant to Article 19, the Commission shall, where necessary for the coordination of the response at Union level or upon request of the HSC referred to in Article 21 or on its own initiative, make promptly available to the national competent authorities and to the HSC, through the EWRS, a risk assessment of the potential severity of the threat to public health, including possible public health measures. That risk assessment shall be carried out on their own initiative or at the request of the Commission by:
Amendment 571 #
Proposal for a regulation Article 20 – paragraph 1 – introductory part 1. Where an alert is notified pursuant to Article 19, the Commission shall, where necessary for the coordination of the response at Union level or upon request of the HSC referred to in Article 21 or on its own initiative, make promptly available to the national, and regional where appropriate, competent authorities and to the HSC, through the EWRS, a risk assessment of the potential severity of the threat to public health, including possible public health measures. That risk assessment shall be carried out by:
Amendment 572 #
Proposal for a regulation Article 20 – paragraph 1 – point a (a) the ECDC in accordance with Article 8a of Regulation (EU) …/… [OJ: Please insert the number of Regulation ECDC [ISC/2020/ 12527]] in the case of a threat referred to in points (i) and (ii) of point (a) of Article 2(1) including substances of human origin
Amendment 573 #
Proposal for a regulation Article 20 – paragraph 1 – point a (a) the ECDC in accordance with Article 8a of Regulation (EU) …/… [OJ: Please insert the number of Regulation ECDC [ISC/2020/ 12527]] in the case of a threat referred to in
Amendment 574 #
Proposal for a regulation Article 20 – paragraph 1 – point a a (new) (a a) the European Medicines Agency (EMA), in accordance with Article 1 of Regulation (EU) 2021/... [insert the number of revised EMA regulation 2020/0321(COD)], in the case of a shortage of medical products for human use or medical devices that potentially represents a risk to public health.
Amendment 575 #
Proposal for a regulation Article 20 – paragraph 1 – point f a (new) (f a) Union or national entities engaged in stockpiling of medical products.
Amendment 576 #
Proposal for a regulation Article 20 – paragraph 3 – subparagraph 1 The Commission shall make the risk assessment available to the national, and regional where appropriate, competent authorities promptly through the EWRS, and, if appropriate, through linked alerts systems. Where the risk assessment is to be made public, the national, and regional where appropriate, competent authorities shall receive it prior to its publication.
Amendment 577 #
Proposal for a regulation Article 20 – paragraph 3 – subparagraph 2 The risk assessment shall take into account, if available, relevant information provided by public health experts and other entities, in particular by the WHO
Amendment 578 #
Proposal for a regulation Article 20 – paragraph 4 4. The Commission shall ensure that information that may be relevant for the risk assessment is made available to the national, and regional where appropriate, competent authorities through the EWRS and to the HSC.
Amendment 579 #
Proposal for a regulation Article 21 – paragraph 1 – point a (a) national and regional responses, including research needs, to the serious cross-border threat to health, including where a public health emergency of international concern is declared in accordance with the IHR and falls within Article 2 of this Regulation;
Amendment 580 #
Proposal for a regulation Article 21 – paragraph 1 – point a (
Amendment 581 #
Proposal for a regulation Article 21 – paragraph 1 – point b (b) risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing consistent and coordinated information in the Union to the public and to healthcare professionals. In addition, the Commission shall broaden its communication activity to cover the general public by establishing and managing a portal to share verified information and fight against disinformation;
Amendment 582 #
Proposal for a regulation Article 21 – paragraph 1 – point b (b) risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing consistent and coordinated information in the Union to the public
Amendment 583 #
Proposal for a regulation Article 21 – paragraph 1 – point b (b) risk and crisis communication, to be adapted to Member State needs and circumstances, aimed at providing easy-to- understand, consistent and coordinated information in the Union to the public and to healthcare professionals;
Amendment 584 #
Proposal for a regulation Article 21 – paragraph 1 – point c (c) adoption of opinions and guidance, including on specific response measures for the Member States for the prevention and control of a serious cross-border threat to health, including coordination of response measures.
Amendment 585 #
Proposal for a regulation Article 21 – paragraph 1 – point c (c) adoption of opinions and
Amendment 586 #
Proposal for a regulation Article 21 – paragraph 1 – point c a (new) (c a) national travel restrictions and other cross-border restrictions on movement and the gathering of people, as well as quarantine requirements and supervision of quarantines following cross-border travel.
Amendment 587 #
Proposal for a regulation Article 21 – paragraph 1 – point c a (new) (c a) coordination with relevant third- party stakeholders (such as manufacturers of relevant medical countermeasures), to explore and anticipate appropriate responses in order to rapidly address the alert.
Amendment 588 #
Proposal for a regulation Article 21 – paragraph 1 a (new) 1 a. communication with relevant third-party stakeholders, including manufacturers of relevant medical countermeasures, to explore responses to a serious cross-border threat to health;
Amendment 589 #
Proposal for a regulation Article 21 – paragraph 2 2. Where a Member State intends to adopt or cease public health measures to combat a serious cross-border threat to health, it shall, before adopting or ceasing those measures, inform
Amendment 590 #
Proposal for a regulation Article 21 – paragraph 2 2. Where a Member State intends to adopt public health measures to combat a serious cross-border threat to health, it shall, before adopting those measures, inform and consult the other Member States, in particular neighbouring Member States, and the Commission on the nature, purpose and scope of the measures, unless the need to protect public health is so urgent that the immediate adoption of the measures is necessary.
Amendment 591 #
Proposal for a regulation Article 21 – paragraph 3 3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States
Amendment 592 #
3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and the Commission on the nature, purpose and scope of those measures, especially in cross-border regions, who shall also be accordingly informed.
Amendment 593 #
Proposal for a regulation Article 21 – paragraph 3 3. Where a Member State has to adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall, immediately upon adoption, inform the other Member States and relevant regional authorities and the Commission on the nature, purpose and scope of those measures, especially in cross-border regions.
Amendment 594 #
Proposal for a regulation Article 21 – paragraph 3 3. Where a Member State has to immediately adopt, as a matter of urgency, public health measures in response to the appearance or resurgence of a serious cross-border threat to health, it shall,
Amendment 595 #
Proposal for a regulation Article 21 – paragraph 3 a (new) 3 a. Where the public health measures that a Member State adopts to counter a serious cross-border threat to health lasts or is extended for more than 14 days, it shall inform the other Member States and the Commission about the scientific evidence that justify the necessity, suitability and proportionality of the continuity of such measures to attain the purpose stated in the communications referred to in paragraphs 2and 3.
Amendment 596 #
Proposal for a regulation Article 22 – paragraph 1 1. The Commission may complement the action of the Member States through
Amendment 597 #
Proposal for a regulation Article 22 – paragraph 2 – point a (a) be based on in particular recommendations of the ECDC
Amendment 598 #
Proposal for a regulation Article 22 – paragraph 2 – point b (b) respect the responsibilities of the Member States, and the regions where appropriate, for the definition of their health policy and for the organisation and delivery of health services and medical care;
Amendment 599 #
Proposal for a regulation Article 22 – paragraph 2 – point c (c) be necessary, suitable and proportionate to the public health risks related to the threat in question, avoiding in particular any unnecessary restriction to the free movement of persons, of goods and of services, and to the rights, freedoms and principles enshrined in the Charter of Fundamental Rights of the European Union.
Amendment 600 #
Proposal for a regulation Article 22 – paragraph 2 – point c (c) be proportionate to the public health risks related to the threat in question, avoiding in particular any unnecessary restriction to the free
Amendment 601 #
Proposal for a regulation Article 22 – paragraph 2 – point c (c) be proportionate to the public health risks related to the threat in question,
Amendment 602 #
Proposal for a regulation Article 22 – paragraph 2 – point c a (new) (c a) assess the overall strategic implications of the public health measures proposed in the recommendation, with special regard for their economic, political, social and psychological consequences.
Amendment 603 #
(c a) be time limited, and cease as soon as one of the applicable conditions of (a), (b) and (c) is no longer met.
Amendment 604 #
Proposal for a regulation Article 23 – paragraph 2 2. The Commission shall terminate the recognition referred to in paragraph 1 as soon as one of the applicable conditions laid down therein is no longer
Amendment 605 #
Proposal for a regulation Article 23 – paragraph 3 3. Before recognising a situation of public health emergency at Union level, the Commission sh
Amendment 606 #
Proposal for a regulation Article 23 – paragraph 3 3. Before recognising a situation of public health emergency at Union level, the Commission sh
Amendment 607 #
Proposal for a regulation Article 23 – paragraph 4 – subparagraph 1 Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 27(
Amendment 608 #
Proposal for a regulation Article 23 – paragraph 4 – subparagraph 2 Amendment 609 #
Proposal for a regulation Article 24 – paragraph 1 – introductory part 1. For the purpose of the formal recognition of a public health emergency at Union level, the Commission, with the consultation of the Health Security Committee shall establish an Advisory Committee on public health emergencies (‘Advisory Committee’) which, at the request of the Commission
Amendment 610 #
Proposal for a regulation Article 24 – paragraph 1 – introductory part 1. For the purpose of the formal
Amendment 611 #
Proposal for a regulation Article 24 – paragraph 1 – point a (a) whether a threat constitutes a public health emergency at Union level after consulting the ECDC on the matter;
Amendment 612 #
Proposal for a regulation Article 24 – paragraph 1 – point b (
Amendment 613 #
(ii) identification and mitigation of significant gaps, inconsistencies or inadequacies in measures taken or to be taken to contain and manage the specific threat and overcome its impact, including in clinical management and treatment, non- pharmaceutical countermeasures, global supply chain involved in the production and manufacturing of medical countermeasures needed for the prevention, diagnosis, treatment and follow-up of the disease concerned and public health research needs;
Amendment 614 #
Proposal for a regulation Article 24 – paragraph 1 – point c – point ii (ii) identification and mitigation of significant gaps, inconsistencies or inadequacies in measures taken or to be taken to contain and manage the specific threat and overcome its impact, including in clinical management and treatment,
Amendment 615 #
Proposal for a regulation Article 24 – paragraph 1 – point c – point iii (
Amendment 616 #
Proposal for a regulation Article 24 – paragraph 2 2. The Advisory Committee shall be composed of independent experts, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, cultural and international aspects. The Commission shall make public the selected experts and the professional and/or scientific backgrounds that support their nomination. The representatives of the ECDC and of the EMA participate as observers in the Advisory Committee. The representatives of other Union bodies or agencies relevant to the specific threat shall participate as observers in this Committee as necessary. The Commission may invite experts with specific expertise with respect to a subject matter on the agenda to take part in the work of the Advisory Committee on an ad-
Amendment 617 #
Proposal for a regulation Article 24 – paragraph 2 2. The Advisory Committee shall be composed of
Amendment 618 #
Proposal for a regulation Article 24 – paragraph 2 2. The Advisory Committee shall be composed of independent experts, selected
Amendment 619 #
Proposal for a regulation Article 24 – paragraph 2 2. The Advisory Committee shall be composed of independent experts and representatives of health and care workers, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on sanitary, biomedical, behavioural, social, economic, cultural and international aspects. The representatives of the ECDC and of the EMA participate as observers in the Advisory Committee. The representatives of other Union bodies or agencies relevant to the specific threat shall participate as observers in this Committee as necessary.
Amendment 620 #
Proposal for a regulation Article 24 – paragraph 2 2. The Advisory Committee shall be composed of independent experts, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, manufacturing, research, development, cultural and international aspects. The representatives of the ECDC and of the EMA participate as observers in the Advisory Committee. The representatives of other Union bodies or agencies relevant to the specific threat shall participate as observers in this Committee as necessary. The Commission may invite experts and stakeholders with specific expertise with respect to a subject matter on the agenda to take part in the work of the Advisory Committee on an ad-
Amendment 621 #
Proposal for a regulation Article 24 – paragraph 2 2. The Advisory Committee shall be composed of independent experts, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, manufacturing, research, development, cultural and international aspects. The representatives of the ECDC and of the EMA participate as observers in the Advisory Committee. The representatives of other Union bodies or agencies relevant to the specific threat shall participate as observers in this Committee as necessary. The Commission may invite experts and stakeholders with specific expertise with respect to a subject matter on the agenda to take part in the work of the Advisory Committee on an ad-
Amendment 622 #
Proposal for a regulation Article 24 – paragraph 2 2. The Advisory Committee shall be composed of independent experts
Amendment 623 #
Proposal for a regulation Article 24 – paragraph 2 2. The Advisory Committee shall be composed of independent experts, selected by the Commission according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on biomedical, behavioural, social, economic, cultural and international aspects. The representatives of the ECDC and of the EMA
Amendment 624 #
Proposal for a regulation Article 24 – paragraph 2 2. The Advisory Committee shall be composed of independent experts, selected by the Commission, after prior consultation of the Member States, according to the fields of expertise and experience most relevant to the specific threat that is occurring. The Committee should have multidisciplinary membership so it can advise on
Amendment 625 #
Proposal for a regulation Article 24 – paragraph 2 a (new) 2 a. All members of the Advisory Committee shall provide declarations of interest in line with the applicable rules in each case.
Amendment 626 #
Proposal for a regulation Article 24 – paragraph 3 3. The Advisory Committee shall meet whenever the situation requires, on a request from the Commission, the Health Security Committee or a Member State.
Amendment 627 #
Proposal for a regulation Article 24 – paragraph 3 3. The Advisory Committee shall meet when
Amendment 628 #
Proposal for a regulation Article 24 – paragraph 4 4. The Advisory Committee shall be chaired by a representative of the Commission. The chair shall have no voting rights.
Amendment 629 #
Proposal for a regulation Article 24 – paragraph 6 6. The Advisory Committee shall establish its rules of procedure including on the rules for the declaration and termination of an emergency situation, and adoption of recommendations and voting. The rules of procedures shall enter into force after receiving a favourable opinion from the Commission and the Health Security Committee.
Amendment 630 #
Proposal for a regulation Article 24 – paragraph 6 a (new) 6 a. The list of members of the Advisory Committee shall be made public on the Commission website. Members of the Committee must 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 indirect interests which could relate to the medical or other relevant industry shall be entered in a register held by the Commission and be accessible to the public, upon request.
Amendment 631 #
6 a. The minutes of the Advisory Committee shall be public.
Amendment 632 #
Proposal for a regulation Article 25 – paragraph 1 – point b (b) mechanisms to monitor shortages of, develop, procure, man
Amendment 633 #
Proposal for a regulation Article 25 – paragraph 1 – point b (b) mechanisms to monitor shortages of, develop, procure, ensure security of supply, manage and deploy medical countermeasures;
Amendment 634 #
Proposal for a regulation Article 25 – paragraph 1 – point c a (new) (c a) A Union export control mechanism with the aim of enabling the Union to guarantee timely and effective access to counter-measures.
Amendment 635 #
Proposal for a regulation Article 26 – paragraph 1 1. The EWRS shall include a selective messaging functionality allowing personal data, including contact and health data, to be communicated only to national and regional competent authorities involved in the contact tracing measures concerned. That selective messaging functionality shall be designed and operated so as to ensure safe and lawful processing of personal data and to link with contact tracing systems at Union level.
Amendment 636 #
Proposal for a regulation Article 26 – paragraph 5 5. Personal data may also be exchanged in the context of automated
Amendment 637 #
Proposal for a regulation Article 26 – paragraph 5 5. Personal data may also be exchanged in the context of automated contact tracing, using contact tracing applications, in full compliance with the Regulation (EU) 20176/679 ('GDPR').
Amendment 638 #
Proposal for a regulation Article 26 – paragraph 6 – point b (b) procedures for the interlinking of the EWRS with contact tracing systems at Union level and international level;
Amendment 639 #
(b) procedures for the interlinking of the EWRS with contact tracing systems at Union and international level;
Amendment 640 #
Proposal for a regulation Article 26 – paragraph 6 – point c a (new) (c a) the establishment and update of a list of relevant health data to be automatically collected by digital platforms.
Amendment 641 #
Proposal for a regulation Article 26 – paragraph 6 a (new) 6 a. This Regulation shall be without prejudice to the obligations of Member States relating to their processing of personal data under Regulation (EU) No 2016/679 and Directive 2002/58/EC on privacy and electronic communications, or the obligations of Union agencies and the Commission relating to their processing of personal data under Regulation (EU)No 2018/1725, when fulfilling their responsibilities.
Amendment 642 #
Proposal for a regulation Article 29 – paragraph 1 By
Amendment 643 #
Proposal for a regulation Article 29 – paragraph 1 a (new) Based on the evaluation referred to in the previous subparagraph, the Commission shall, where appropriate, submit a legislative proposal to amend this Regulation.
source: 692.634
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