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
- Amendments tabled in committee 2021/04/29
- Amendments tabled in committee 2021/04/29
- Committee draft report 2021/03/23
- Contribution 2021/03/23
- Contribution 2021/02/24
- Contribution 2021/02/21
- ANDRESEN Rasmus (Verts/ALE) appointed as rapporteur in IMCO 2021/01/26
- Committee referral announced in Parliament, 1st reading 2020/12/14
- TRILLET-LENOIR Véronique (Renew) appointed as rapporteur in ENVI 2020/11/26
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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- David Maria SASSOLI
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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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