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
- Committee of the Regions: opinion 2021/05/07
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
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.
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.
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
- 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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- Roberta METSOLA
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- Alessandra MORETTI
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- Sirpa PIETIKÄINEN
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- João PIMENTA LOPES
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- Christel SCHALDEMOSE
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- Maria SPYRAKI
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- Johan VAN OVERTVELDT
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- Clare DALY
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- Nicolae ŞTEFĂNUȚĂ
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- Robert HAJŠEL
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- Rasmus ANDRESEN
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- Nicolás GONZÁLEZ CASARES
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- Irena JOVEVA
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- Mislav KOLAKUŠIĆ
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- Joachim KUHS
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- Stelios KYMPOUROPOULOS
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- Mick WALLACE
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- Bartosz ARŁUKOWICZ
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- Nathalie COLIN-OESTERLÉ
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- Loucas FOURLAS
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- Radan KANEV
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- Joanna KOPCIŃSKA
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- Domènec RUIZ DEVESA
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- Edina TÓTH
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- Eugen JURZYCA
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- Sara CERDAS
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- Heléne FRITZON
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- Adriana MALDONADO LÓPEZ
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- Ivo HRISTOV
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- Beata MAZUREK
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- Kim VAN SPARRENTAK
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- Liudas MAŽYLIS
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- Tomislav SOKOL
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- Gianantonio DA RE
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- Véronique TRILLET-LENOIR
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- Cindy FRANSSEN
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- Günther SIDL
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- Mathilde ANDROUËT
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- Pernille WEISS
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- Antoni COMÍN I OLIVERES
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- Margarita DE LA PISA CARRIÓN
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- Alin MITUȚA
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Amendments | Dossier |
165 |
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
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History
(these mark the time of scraping, not the official date of the change)
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https://www.europarl.europa.eu/doceo/document/ENVI-AM-692634_EN.html
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https://www.europarl.europa.eu/doceo/document/ENVI-AM-692635_EN.html
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European Economic and Social Committee European Committee of the Regions
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