2020/0102(COD) Programme for the Union's action in the field of health for the period 2021-2027 (“EU4Health Programme”)
Next event: Commission response to text adopted in plenary 2021/05/03 more...
Lead committee dossier:
Next event: Commission response to text adopted in plenary 2021/05/03 more...
- Final act published in Official Journal 2021/03/26
- End of procedure in Parliament 2021/03/25
- Draft final act 2021/03/24
- Final act signed 2021/03/24
- Act adopted by Council after Parliament's 1st reading 2021/03/18
- Results of vote in Parliament 2021/03/09
- Debate in Parliament 2021/03/09
- Decision by Parliament, 1st reading 2021/03/09
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations 2021/01/13
- Coreper letter confirming interinstitutional agreement 2020/12/18
- Text agreed during interinstitutional negotiations 2020/12/18
- Decision by Parliament, 1st reading 2020/11/13
- Matter referred back to the committee responsible 2020/11/13
- Debate in Parliament 2020/11/12
- Committee report tabled for plenary, 1st reading 2020/10/20
- Vote in committee, 1st reading 2020/10/14
- Committee opinion 2020/09/14
- Committee opinion 2020/09/01
- ZACHAROPOULOU Chrysoula (Renew) appointed as rapporteur in FEMM 2020/08/25
- Contribution 2020/07/28
Progress: Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | ENVI |
BUŞOI Cristian-Silviu ( EPP)
|
CERDAS Sara ( S&D),
TRILLET-LENOIR Véronique ( Renew),
RIVASI Michèle ( Verts/ALE),
REGIMENTI Luisa ( ID),
KOPCIŃSKA Joanna ( ECR),
KONEČNÁ Kateřina ( GUE/NGL)
|
| Committee Opinion | FEMM |
ZACHAROPOULOU Chrysoula ( Renew)
|
Maria NOICHL ( S&D),
Alice KUHNKE ( Verts/ALE),
Frances FITZGERALD ( PPE),
Margarita DE LA PISA CARRIÓN ( ECR)
|
| Committee Opinion | IMCO | ||
| Committee Opinion | BUDG |
ŞTEFĂNUȚĂ Nicolae ( Renew)
|
Lefteris CHRISTOFOROU ( PPE),
Victor NEGRESCU ( S&D),
Johan VAN OVERTVELDT ( ECR),
Rasmus ANDRESEN ( Verts/ALE),
Hélène LAPORTE ( ID)
|
| Committee Opinion | ITRE | ||
| Committee Opinion | EMPL |
Lead committee dossier:
Legal Basis:
TFEU 168-p5
Legal Basis:
TFEU 168-p5Subjects
Events
2021/05/03
EC - Commission response to text adopted in plenary
Documents
2021/03/26
Final act published in Official Journal
2021/03/25
EP - End of procedure in Parliament
2021/03/24
CSL - Draft final act
Documents
2021/03/24
CSL - Final act signed
2021/03/18
EP/CSL - Act adopted by Council after Parliament's 1st reading
2021/03/09
EP - Results of vote in Parliament
Documents
2021/03/09
EP - Debate in Parliament
Documents
2021/03/09
EP - Decision by Parliament, 1st reading
Details
The European Parliament adopted by 631 votes to 32, with 34 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on the establishment of a Programme for the Union's action in the field of health – for the period 2021-2027 and repealing Regulation (EU) No 282/2014 (EU4Health Programme).
The European Parliament's position adopted at first reading under the ordinary legislative procedure amends the Commission's proposal as follows:
Programme’s objectives
The programme would be established for the period of the multiannual financial framework 2021-2027 and would complement Member States' policies, with a view to improving human health throughout the Union and ensuring a high level of human health protection in all EU policies and activities. It should promote actions in areas where there is EU added value.
In line with the ‘One Health’ approach, the programme should:
- improve and foster health in the Union to reduce the burden of communicable and non-communicable diseases, by supporting health promotion and disease prevention, by reducing health inequalities, by fostering healthy lifestyles and by promoting access to healthcare;
- protect people in the Union from serious cross-border threats to health and strengthening the responsiveness of health systems and coordination among the Member States in order to cope with serious cross-border threats to health;
- improve the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and support innovation regarding such products;
- strengthen health systems by improving their resilience and resource efficiency, in particular through: (i) supporting integrated and coordinated work between Member States; (ii) promoting the implementation of best practices and promoting data sharing; (iii) reinforcing the healthcare workforce; (iv) tackling the implications of demographic challenges; and (v) advancing digital transformation.
Supporting actions
In order to achieve these objectives, Parliament insisted, inter alia , on:
- supporting actions to: (i) prevent disease, including reducing health damage from illicit drug use and addiction, (ii) end health inequalities, (iii) improve surveillance, diagnosis and treatment of communicable and non-communicable diseases, in particular cancer and paediatric cancer, and (v) improve mental health;
- improving health crisis management, in particular through the coordination, provision and deployment of emergency health resources, information exchange, surveillance and coordination of voluntary testing of national health care systems
- encouraging sustainable production and supply chains and innovation in the EU;
- promoting the safe use of medicines, in particular antimicrobials, and actions to support the development of environmentally friendly medicines;
- the establishment, in synergy with other EU instruments, of a structure and training resources for a reserve of medical, nursing and support staff assigned voluntarily by Member States and ready to be mobilised in the event of a health crisis;
- support for the creation of a European Health Data Space;
- support for global commitments and health initiatives.
Budget
It is proposed that the financial envelope for the implementation of the programme for the period 2021-2027 be set at EUR 2 446 000 000 in current prices. This amount would be increased by an additional allocation of EUR 2 900 000 000 in 2018 prices.
The distribution of the amounts should respect the following criteria:
- a minimum of 20 % for health promotion and disease prevention actions;
- a maximum of 12.5 % for procurement complementing national stockpiling of essential crisis-relevant products at EU level;
- a maximum of 12.5 % to support global commitments and health initiatives;
- a maximum of 8 % to cover administrative expenses.
Grants
Grants paid by the Union should not exceed 60 % of eligible costs for an action relating to an objective of the Programme or for the functioning of a non-governmental body. In cases of exceptional utility, the contribution by the Union may be up to 80 % of eligible costs.
Actions with a clear EU added value should be considered to have exceptional utility, in particular, where at least 30 % of the budget of the proposed action is allocated to Member States whose GNI per inhabitant is less than 90 % of the Union average.
Governance
To achieve coherent implementation of the programme's actions, an EU Health Steering Group would be established.
The Commission should consult relevant stakeholders, including representatives of civil society and patient organisations, to seek their views on the priorities and strategic orientations of the annual work programme.
Each year, the Commission should present to the European Parliament the results of the work of the EU Health Steering Group and the stakeholder consultations.
Documents
2021/01/13
EP - Approval in committee of the text agreed at 1st reading interinstitutional negotiations
Documents
2020/12/18
CSL - Coreper letter confirming interinstitutional agreement
Documents
2020/12/18
EP - Text agreed during interinstitutional negotiations
Documents
2020/11/13
EP - Decision by Parliament, 1st reading
Details
The European Parliament adopted by 612 votes to 41, with 36 abstentions, amendments to the proposal for a Regulation of the European Parliament and of the Council on the establishment of a Programme for the Union's action in the field of health for the period 2021-2027 and repealing Regulation (EU) No 282/2014 (EU4Health Programme).
The matter was referred back to the committee responsible for inter-institutional negotiations.
The main amendments adopted in plenary concern the following points:
Programme’s objectives
In keeping with the ‘One Health’ and ‘Health in all policies’ approaches, the programme would:
- improve and foster health in the EU, by supporting health promotion and disease prevention, reducing health inequalities and ensuring equal and full access to health;
- protect people in the EU from any serious cross-border threats to health;
- support the development and implementation of better preparedness and coordination within and between Member States as regards health emergencies;
- support existing and future EU legislation and policies restore pharmaceutical independence and address shortages, improve the availability, accessibility and affordability of health care and services in the EU;
- share comparable and interoperable data, with the aim of increasing the general level of public health, health literacy and make health systems more resilient and responsive.
To achieve these objectives, Parliament insisted, inter alia , on:
- the coordination of stress testing of national healthcare systems;
- supporting actions contributing to the availability in the EU, during a crisis, of health crisis relevant products such as essential medicines, vaccines and medical devices;
- strengthening the European medicines market;
- creating and implementing a European Health Data Space;
- strengthening EU innovation to ensure the development and uptake of the next generation of medicines, vaccines and medical devices;
- EU action against cancer and support for the early diagnosis of neurodegenerative and other brain diseases;
- addressing vaccination hesitancy;
- the development of medicines that are less harmful to the environment.
Budget
Parliament proposed that the financial framework for the implementation of the programme for the period 2021-2027 be set at EUR 10 398 000 000 in current prices (i.e. EUR 9 370 000 000 in constant prices). The administrative expenditure related to indirect actions should not exceed 5% of the total amount of the programme.
Implementation and forms of EU funding
The Commission should facilitate the consistent implementation of the programme while seeking maximal administrative simplification and fostering synergies between the programme and other EU programmes and funds. A reliable and efficient mechanism would be created to avoid any duplication of funding.
The award criteria would be defined in the programmes and calls for proposals, taking into account, as far as applicable, a number of elements such as the cross-border dimension, the contribution to digital transformation, the social impact (benefits and costs), the contribution to the prevention of diseases, in particular cancer, and the contribution to access to medicines.
To achieve a coherent implementation of the Programme's actions, an EU Health Steering Group should be established.
Documents
2020/11/13
EP - Matter referred back to the committee responsible
2020/11/12
EP - Debate in Parliament
Documents
2020/10/20
EP - Committee report tabled for plenary, 1st reading
Details
The Committee on the Environment, Public Health and Food Safety adopted a report by Cristian-Silviu BUŞOI (EPP, RO) on the proposal for a regulation of the European Parliament and of the Council on the establishment of a Programme for the Union's action in the field of health for the period 2021-2027 and repealing Regulation (EU) No 282/2014 (EU4Health Programme).
The severity of the COVID-19 pandemic pushed several health systems to breaking point within and outside of the Union. While the Union´s action in the field of health is limited, a separate and robust Programme shall have the capacity to deliver on future pandemics and health threats, and very importantly, make EU health systems more resilient, able to face current weaknesses, such as medicine shortages, antimicrobial resistance, health inequalities and support health sector in the digital transition.
The committee recommended that the European Parliament’s position, adopted at first reading under the ordinary legislative procedure, should amend the Commission proposal as follows.
Budget
The proposed financial envelope for the implementation of the Programme for the period 2021-27 shall be EUR 10 398 000 000 in current prices (EUR 9 370 000 000 in constant prices). This budget shall be frontloaded, meaning that there is a need for clear and focused objectives. The administrative expenses related to indirect actions shall not exceed 5% of the total amount under the Programme.
General objectives
Members stressed that a holistic approach is needed to improve health outcomes, and EU policy-makers should ensure that the principle of 'health in all policies' is applied in all policy-making. In this regard, the proposed Programme shall pursue, inter alia , the following general objectives, in keeping with this principle:
- improve and foster health in the Union, by supporting health promotion and disease prevention, reducing health inequalities and ensuring equal and full access to health;
- protect people in the Union from any serious cross-border threats to health;
- support the development and implementation of better preparedness and coordination within and between Member States as regards health emergencies;
- support existing and future Union legislation and policies to restore pharmaceutical independence and address shortages;
- strengthen the Union fight against cancer in synergy with the Europe’s Beating Cancer Plan, including by supporting actions for the surveillance, prevention, early diagnosis and treatment and care of cancer, including paediatric cancer;
- address vaccine hesitancy, and support action for the elimination of vaccine preventable diseases, including cancers.
Enhance European Reference Networks (ERNs)
Adequate funding shall be ensured to consolidate and expand the ERN model of cross-border healthcare by securing the provision of a range of clinical services through different channels, including online second opinions and specialist advice for patients on treatment and management and ‘online out-patient’ clinics. These networks shall be extended in the form of Excellence Networks in the field of communicable and noncommunicable diseases.
Communication portal
The report proposed the setting up of a communication portal for the public which would allow the Union to share validated information, send alerts to European citizens and fight against disinformation. This portal may also be used to promote, in cooperation with the European Centre for Disease Control (‘ECDC’), a strong immunisation coverage at European level.
Synergies
A EU4Health Steering Board shall be created with a focus on creating synergies between the Programme and other programmes where a health dimension is integrated, through coordination and cooperation, promoting patients and society engagement, and providing scientific advice and recommendations.
The Commission shall propose a new Union strategic framework on occupational safety and health for the period 2021-2027 and continue updating the directive on the protection of workers from the risks related to carcinogens or mutagens at work.
Documents
2020/10/14
EP - Vote in committee, 1st reading
2020/09/14
EP - Committee opinion
Documents
2020/09/01
EP - Committee opinion
Documents
2020/08/25
EP - ZACHAROPOULOU Chrysoula (Renew) appointed as rapporteur in FEMM
2020/07/28
PT_PARLIAMENT - Contribution
Documents
2020/07/16
EP - Amendments tabled in committee
Documents
2020/07/16
EP - Amendments tabled in committee
Documents
2020/07/02
ES_PARLIAMENT - Contribution
Documents
2020/06/18
EP - ŞTEFĂNUȚĂ Nicolae (Renew) appointed as rapporteur in BUDG
2020/06/17
EP - Committee draft report
Documents
2020/06/17
EP - Committee referral announced in Parliament, 1st reading
2020/06/02
EP - BUŞOI Cristian-Silviu (EPP) appointed as rapporteur in ENVI
2020/05/28
EC - Legislative proposal published
Details
PURPOSE: to establish a programme for the Union’s action in the field of health for the period 2021-2027 (EU4Health programme).
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 on an equal footing with the Council.
BACKGROUND: while Member States are responsible for their health policies, the experience gained during the COVID-19 crisis has shown the need to significantly strengthen the EU's capacity to respond effectively to major health threats. Europe needs to give higher priority to health, to have health systems ready to provide state-of-the-art care and to be prepared to deal with epidemics and other unpredictable health threats, in line with the International Health Regulations (IHR).
The Commission proposes that an ambitious stand-alone programme, called the EU4Health Programme, is the key instrument to implement this strategy.
The new programme will be essential to ensure that the EU remains the healthiest region in the world, that it has all possible tools to address health challenges at national and European level and that it is ready to respond to any new and emerging health threats that may endanger the population of the EU.
CONTENT: the proposed Regulation aims to establish a new programme for EU action in the field of health, entitled ‘ EU4Health Programme ’ (EU4Health) for the period 2021-2027.
General objectives
The Programme shall pursue the following general objectives:
(1) protect people in the Union from serious cross-border threats to health;
(2) improve the availability in the Union of medicines, medical devices and other crisis relevant products, contribute to their affordability, and support innovation;
(3) strengthen health systems and the healthcare workforce, including by digital transformation and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and data sharing, to increase the general level of public health.
From the point of view of recovery from the COVID-19 crisis, the Programme should help to ensure that the EU is better prepared to deal with future health threats that would affect all or a large part of its territory.
The Programme shall:
- support Member States in the transition to better preparedness and the reinforcement of their health systems and support them in achieving the health-related United Nations Sustainable Development Goals (SDGs);
- set out key action areas such as improvement of national health systems, measures against communicable and non-communicable diseases, availability and affordability of medicines and other crisis relevant products;
- address inequalities by benchmarking, providing support and closing identified gaps between countries, regions, population groups and citizens;
- provide tools for enhanced solidarity in preparedness and crisis response, as well as in finding common ground to improve prevention and in addressing non-communicable diseases, and in particular cancer, and for better coordinating between different policies, tools and financial instruments;
- contribute to tackling the negative impact of climate change and environmental degradation on human health;
- support actions to enable the Commission to complement the necessary regulatory framework and contribute to addressing the significant structural needs identified in the COVID-19 crisis.
Implementation
The Programme shall be implemented through direct or indirect management and shall make use of the most commonly used spending mechanisms of the Union budget, including public procurement, prizes and grants.
Funding for health under the next Multiannual Financial Framework (MFF) for the period 2021-2027 includes several instruments such as the European Social Fund plus (ESF+), the European Regional Development Fund, the Horizon Europe Programme, the Digital Europe Programme and the Interconnection in Europe 2 mechanism.
Working across programmes and sharing objectives between strategies will be key to channelling health funds between strategies and supporting the achievement of their objectives more effectively than before.
Proposed budget
The total budget allocated to the programme shall amount to EUR 10 397 614 000 (in current prices) for the period 2021-2027:
- EUR 1 946 614 000 shall derive from heading 5 ‘Resilience, Security and Defence’ of the MFF for the period 2021-2027;
- EUR 8 451 000 000 shall derive from proceeds of the EU Recovery Instrument, constituting external assigned revenues.
Documents
Documents
- Commission response to text adopted in plenary: SP(2021)234
- Final act published in Official Journal: Regulation 2021/522
- Final act published in Official Journal: OJ L 107 26.03.2021, p. 0001
- Draft final act: 00069/2020/LEX
- Results of vote in Parliament: Results of vote in Parliament
- Debate in Parliament: Debate in Parliament
- Decision by Parliament, 1st reading: T9-0069/2021
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: PE689.581
- Approval in committee of the text agreed at 1st reading interinstitutional negotiations: GEDA/A/(2021)001000
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2021)001000
- Text agreed during interinstitutional negotiations: PE689.581
- Decision by Parliament, 1st reading: T9-0304/2020
- Debate in Parliament: Debate in Parliament
- Committee report tabled for plenary, 1st reading: A9-0196/2020
- Committee opinion: PE657.308
- Committee opinion: PE653.947
- Contribution: COM(2020)0405
- Amendments tabled in committee: PE653.822
- Amendments tabled in committee: PE655.706
- Contribution: COM(2020)0405
- Committee draft report: PE653.803
- Legislative proposal published: COM(2020)0405
- Legislative proposal published: EUR-Lex
- Committee draft report: PE653.803
- Amendments tabled in committee: PE653.822
- Amendments tabled in committee: PE655.706
- Committee opinion: PE653.947
- Committee opinion: PE657.308
- Coreper letter confirming interinstitutional agreement: GEDA/A/(2021)001000
- Text agreed during interinstitutional negotiations: PE689.581
- Draft final act: 00069/2020/LEX
- Commission response to text adopted in plenary: SP(2021)234
- Contribution: COM(2020)0405
- Contribution: COM(2020)0405
Activities
- Cristian-Silviu BUŞOI
Plenary Speeches (0)
- Daniel BUDA
Plenary Speeches (0)
- Maria da Graça CARVALHO
Plenary Speeches (0)
- Dita CHARANZOVÁ
Plenary Speeches (0)
- Lefteris CHRISTOFOROU
Plenary Speeches (0)
- João FERREIRA
Plenary Speeches (0)
- Jytte GUTELAND
Plenary Speeches (0)
- Krzysztof HETMAN
Plenary Speeches (0)
- Othmar KARAS
Plenary Speeches (0)
- Seán KELLY
Plenary Speeches (0)
- Kateřina KONEČNÁ
Plenary Speeches (0)
- Peter LIESE
Plenary Speeches (0)
- Marian-Jean MARINESCU
Plenary Speeches (0)
- Tilly METZ
Plenary Speeches (0)
- Joëlle MÉLIN
Plenary Speeches (0)
- Alessandra MORETTI
Plenary Speeches (0)
- Victor NEGRESCU
Plenary Speeches (0)
- Kostas PAPADAKIS
Plenary Speeches (0)
- Piernicola PEDICINI
Plenary Speeches (0)
- Sirpa PIETIKÄINEN
Plenary Speeches (0)
- Paulo RANGEL
Plenary Speeches (0)
- Michèle RIVASI
Plenary Speeches (0)
- Frédérique RIES
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- Christel SCHALDEMOSE
Plenary Speeches (0)
- Maria SPYRAKI
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- Waldemar TOMASZEWSKI
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- István UJHELYI
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- Johan VAN OVERTVELDT
Plenary Speeches (0)
- Rainer WIELAND
Plenary Speeches (0)
- Nicolae ŞTEFĂNUȚĂ
Plenary Speeches (0)
- Robert HAJŠEL
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- Christine ANDERSON
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- Rasmus ANDRESEN
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- Marc BOTENGA
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- Giorgos GEORGIOU
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- Nicolás GONZÁLEZ CASARES
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- Irena JOVEVA
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- Mislav KOLAKUŠIĆ
Plenary Speeches (0)
- Stelios KYMPOUROPOULOS
Plenary Speeches (0)
- Dolors MONTSERRAT
Plenary Speeches (0)
- Lefteris NIKOLAOU-ALAVANOS
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- Jutta PAULUS
Plenary Speeches (0)
- Ivan Vilibor SINČIĆ
Plenary Speeches (0)
- Magdalena ADAMOWICZ
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- Loucas FOURLAS
Plenary Speeches (0)
- Radan KANEV
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- Joanna KOPCIŃSKA
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- César LUENA
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- Lídia PEREIRA
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- Edina TÓTH
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- Chrysoula ZACHAROPOULOU
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- Anna ZALEWSKA
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- Sara CERDAS
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- Tudor CIUHODARU
Plenary Speeches (0)
- Luisa REGIMENTI
Plenary Speeches (0)
- Jordan BARDELLA
Plenary Speeches (0)
- Beata MAZUREK
Plenary Speeches (0)
- Andżelika Anna MOŻDŻANOWSKA
Plenary Speeches (0)
- Silvia SARDONE
Plenary Speeches (0)
- Tomislav SOKOL
Plenary Speeches (0)
- Véronique TRILLET-LENOIR
Plenary Speeches (0)
- Klára DOBREV
Plenary Speeches (0)
- Cindy FRANSSEN
Plenary Speeches (0)
- Marlene MORTLER
Plenary Speeches (0)
- Maxette PIRBAKAS
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- Günther SIDL
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- Łukasz KOHUT
Plenary Speeches (0)
- Predrag Fred MATIĆ
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- Sunčana GLAVAK
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- Antoni COMÍN I OLIVERES
Plenary Speeches (0)
- Jean-Lin LACAPELLE
Plenary Speeches (0)
- Romana JERKOVIĆ
Plenary Speeches (0)
- Dorien ROOKMAKER
Plenary Speeches (0)
- Linea SØGAARD-LIDELL
Plenary Speeches (0)
- Alin MITUȚA
Plenary Speeches (0)
| Amendments | Dossier |
| 980 |
2020/0102(COD)
2020/07/16
ENVI
980 amendments...
Amendment 1000 #
Proposal for a regulation Annex I – point j – point iii (iii) Support the deployment and interoperability of digital tools and infrastructures within and between Member States and with Union Institutions, Agencies and bodies; including support for the implementation of an Electronic European Health Record; develop appropriate governance structures and sustainable, interoperable Union health information systems, as part of the European Health Data Space and
Amendment 1001 #
Proposal for a regulation Annex I – point j – point iii (iii) Support the deployment, standardization and interoperability of digital tools and infrastructures within and between Member States and with Union Institutions and bodies; develop appropriate governance structures and sustainable, interoperable Union health information systems, as part of the European Health Data Space and strengthen citizens’ access to and control over their health data;
Amendment 1002 #
Proposal for a regulation Annex I – point j – point iii a (new) (iiia) Support actions to promote a European cohesion and coherence policy for digital health in order to harmonize the legal, organizational, semantic and technical components necessary for a functional and efficient cross-border ecosystem;
Amendment 1003 #
Proposal for a regulation Annex I – point j – point iii b (new) (iiib) Support the development of digital tools and digital solutions to increase the use of e-health and improve the sustainability and resilience of healthcare systems;
Amendment 1004 #
Proposal for a regulation Annex I – point j – point iii c (new) (iiic) Support action to scale up cross- border information exchange services and commence the implementation of projects such as Patient Summary and ePrescription;
Amendment 1005 #
Proposal for a regulation Annex I – point j – point iv (iv) Support access to and optimal use of telemedicine/telehealth
Amendment 1006 #
Proposal for a regulation Annex I – point j – point iv (iv) Support access to and optimal use of telemedicine/telehealth, including through satellite communication for remote areas, foster digitally-driven organisational innovation in healthcare facilities and, promote digital tools supporting citizen empowerment and person-centred care
Amendment 1007 #
Proposal for a regulation Annex I – point j – point iv (iv) Support access to and optimal use of telemedicine/telehealth, including through satellite communication for remote areas, foster digitally-driven organisational innovation in healthcare facilities and promote digital tools supporting citizen empowerment and person-centred care
Amendment 1008 #
Proposal for a regulation Annex I – point j – point iv a (new) (iva) Actions to support the involvement of patients and health care professionals in the development, design and deployment of user-centred accessible, secure and efficient digital health innovation;
Amendment 1009 #
Proposal for a regulation Annex I – point j – point iv a (new) (iva) Actions to support the involvement of patients and healthcare professionals in the development, design and deployment of user-centred accessible, secure and efficient digital health innovation;
Amendment 1010 #
Proposal for a regulation Annex I – point j – point iv a (new) (iva) Actions to support the involvement of patients and healthcare professionals in the development, design and deployment of user-centred accessible, secure and efficient digital health innovation;
Amendment 1011 #
Proposal for a regulation Annex I – point k – point ii a (new) (iia) Communication campaign and awareness raising addressed to citizens and stakeholders to promote trust in generic and biosimilar medicines;
Amendment 1012 #
Proposal for a regulation Annex I – point k – point iii (iii) Communication to promote
Amendment 1013 #
Proposal for a regulation Annex I – point k – point iii a (new) (iiia) Communication, information and awareness campaigns on blood, organs, tissues and cells donation, that alert the public to the importance of such donation, in terms of solidarity, health policy and therapeutical benefits;
Amendment 1014 #
Proposal for a regulation Annex I – point k – point iii b (new) (iiib) Communication activities aimed at fighting against misinformation and disinformation, such as fake news, regarding medicines, vaccines, health products, causes and treatments of diseases;
Amendment 1015 #
Proposal for a regulation Annex I – point k – point iii c (new) (iiic) Communication addressed to citizens on health risks from environmental and food issues;
Amendment 1016 #
Proposal for a regulation Annex I – point k a (new) (ka) Specific support for the outermost regions and the overseas countries and territories, in particular through: (i) Investment in health infrastructures and support for the procurement of new medical supplies; (ii) Establishment and management of reserves of products needed during crises so that the EU’s action can be deployed from those territories; (iii) Support for research, drug development, treatments, and measures to provide information on, and raise awareness of, tropical diseases, but also the diseases that particularly affect those territories, especially diabetes and obesity; (iv) Establishment of specific strategies for repatriation to continental Europe in the case of a major health crisis; (v) Support for better understanding, assessment, use and appreciation of endemic medicinal plants and the therapeutic potential of biodiversity.
Amendment 1017 #
Proposal for a regulation Annex II – part 1 – point I I. Quality and completeness of EU and MS preparedness and response planning for serious cross border threats to
Amendment 1018 #
Proposal for a regulation Annex II – part A – point II a (new) IIa. Review existing fast-track flexibilities in the Union approval framework and support pragmatic clinical trials
Amendment 1019 #
Proposal for a regulation Annex II – part A – point III III.
Amendment 1020 #
Proposal for a regulation Annex II – part A – point III III. Number of actions and best practices directly contributing to the SDG 3.4 and SDG 10/Member State
Amendment 1021 #
Proposal for a regulation Annex II – part A – point IV IV. Implementation of
Amendment 1022 #
Proposal for a regulation Annex II – part A – point IV IV. Implementation of best practices by EU Member States addressing health inequalities (SDG 10)
Amendment 1023 #
Proposal for a regulation Annex II – part A – point IV a (new) IVa. Unmet needs in terms of the access to centrally authorised medicines, vaccines or medical devices, due to the lack of affordability, availability and time
Amendment 1024 #
Proposal for a regulation Annex II – part A – point IV b (new) IVb. Universal Health Care (UHC) service coverage index
Amendment 1025 #
Proposal for a regulation Annex II – part B – point 1 a (new) 1a. Number of Member States that implemented the European Electronic Health Record, while providing stronger guarantees for personal data protection
Amendment 1026 #
Proposal for a regulation Annex II – part B – point 1 a (new) 1a. Number of strategic reserves of medicines, vaccines, medical devices and other medical products
Amendment 1027 #
Proposal for a regulation Annex II – part B – point 1 b (new) 1b. Number of strategic reserves of health professionals with training and preparedness to respond to health threats and health crises
Amendment 1028 #
Proposal for a regulation Annex II – part B – point 1 c (new) 1c. Unmet needs in terms of medicines, vaccines, medical devices, due to the lack of availability, affordability or time
Amendment 1029 #
Proposal for a regulation Annex II – part B – point 1 d (new) 1d. The ratio of new medicines or vaccines in the market compared to the number of clinical trials in the Union and per Member State
Amendment 1030 #
Proposal for a regulation Annex II – part B – point 1 e (new) 1e. Universal Health Care (UHC) service coverage index
Amendment 1031 #
Proposal for a regulation Annex II – part B – point 1 f (new) 1f. Creation of the European Health Data Space (EHDS)
Amendment 1032 #
Proposal for a regulation Annex II – part B – point 1 g (new) 1g. Coverage of citizens with access to their data on the EHDS, per Member State
Amendment 1033 #
Proposal for a regulation Annex II – part B – point 1 h (new) 1h. Number of breaches of security of the EHDS
Amendment 1034 #
Proposal for a regulation Annex II – part B – point 1 i (new) 1i. Coverage of health professionals with digital skills, per Member State
Amendment 1035 #
Proposal for a regulation Annex II – part B – point 1 j (new) 1j. Coverage of citizens having the digital skills necessary to use e-health technology, per Member State
Amendment 1036 #
Proposal for a regulation Annex II – part B – point 1 k (new) 1k. Number of health promotion programmes implemented per Member State, based on health issues covered, using the WHO International Classification of diseases (ICD10)
Amendment 1037 #
Proposal for a regulation Annex II – part B – point 1 l (new) 1l. Coverage of workers with access to occupational healthcare services, per Member State
Amendment 1038 #
Proposal for a regulation Annex II – part B – point 1 m (new) 1m. Ratio of environmental health assessments compared to the number of medicines, vaccines and medical devices that entered into the market
Amendment 1039 #
Proposal for a regulation Annex II – part B – point 1 n (new) 1n. Vaccination coverage, by vaccine- preventable-disease, age and sex
Amendment 1040 #
Proposal for a regulation Annex II – part B – point 1 o (new) 1o. Number of Member States that implemented the European Electronic Health Record while providing stronger guarantees for personal data protection
Amendment 1041 #
Proposal for a regulation Annex II – part B – point 1 p (new) 1 p. Age-standardised five-year net survival of cancer, in total, by type of cancer, gender and age
Amendment 1042 #
Proposal for a regulation Annex II – part B – point 1 q (new) 1q. Ratio of Cancer Registries (CRs) to number of Member States (MSs) reporting information of the cancer stage at diagnosis
Amendment 1043 #
Proposal for a regulation Annex II – part B – point 1 r (new) 1r. Age-standardized DALYs attributable to the NCDs (per 100 000 people), by disease, gender and age
Amendment 1044 #
Proposal for a regulation Annex II – part B – point 1 s (new) 1s. Age-standardized NCD mortality rate (per 100 000 people), by disease, by gender and age
Amendment 1045 #
Proposal for a regulation Annex II – part B – point 1 t (new) 1t. Age-standardized deaths attributable to the environment (per 100 000 people) by gender and age
Amendment 1046 #
Proposal for a regulation Annex II – part B – point 1 u (new) 1u. Number of medical doctors (per 10 000 people), by Member State and region
Amendment 1047 #
Proposal for a regulation Annex II – part B – point 1 v (new) 1v. Number of nurses (per 10 000 people), by Member State and region
Amendment 1048 #
Proposal for a regulation Annex II – part B – point 1 w (new) 1w. Number of healthcare professionals (per 10 000 people), by Member State and region
Amendment 1049 #
Proposal for a regulation Annex II – part B – point 1 x (new) 1x. Age-standardised obesity prevalence, by gender and age
Amendment 1050 #
Proposal for a regulation Annex II – part B – point 1 y (new) 1 y. Age-standardised prevalence of people who are overweight, by gender and age
Amendment 1051 #
Proposal for a regulation Annex II – part B – point 1 z (new) 1z. Age-standardised harmful use of alcohol prevalence, by gender and age
Amendment 1052 #
Proposal for a regulation Annex II – part B – point 1 aa (new) 1aa. Age-standardised gambling prevalence, by gender and age
Amendment 1053 #
Proposal for a regulation Annex II – part B – point 1 ab (new) 1ab. Age-standardised proportion of citizens who do not exercise, by gender and age
Amendment 1054 #
Proposal for a regulation Annex II – part B – point 1 ac (new) 1ac. Proportion of HIV/AIDS patients with access to adequate treatment, by gender and age
Amendment 1055 #
Proposal for a regulation Annex II – part B – point 1 ad (new) 1ad. Proportion of Tuberculosis patients with access to adequate treatment, by gender and age
Amendment 1056 #
Proposal for a regulation Annex II – part B – point 1 ae (new) 1ae. Proportion of viral hepatitis patients with access to adequate treatment, by gender and age
Amendment 1057 #
Proposal for a regulation Annex II – part B – point 1 af (new) 1af. Maternal mortality ratio (per 100 000 live births)
Amendment 1058 #
Proposal for a regulation Annex II – part B – point 1 ag (new) 1ag. Infant mortality rate (per 100 000 live births);
Amendment 1059 #
Proposal for a regulation Annex II – part 2 – point 3 3.
Amendment 1060 #
Proposal for a regulation Annex II – part 2 – point 3 3. Number of vaccine doses distributed and immunisation coverage rates
Amendment 1061 #
Proposal for a regulation Annex II – part B – point 3 3. Number of vaccine doses distributed [by type and MS]
Amendment 1062 #
Proposal for a regulation Annex II – part B – point 3 a (new) 3a. Ratio of use of generic and biosimilar medicines
Amendment 1063 #
Proposal for a regulation Annex II – part B – point 5 a (new) 5a. Number of cancer cases [by organ and MS]
Amendment 1064 #
Proposal for a regulation Annex II – part B – point 6 6. Age-standardised five-year net
Amendment 1065 #
Proposal for a regulation Annex II – part B – point 6 6. Age-standardised five-year net survival of cervical, breast and colorectal cancer, heart attacks and stroke
Amendment 1066 #
Proposal for a regulation Annex II – part B – point 7 7. Ratio of Cancer Registries (CRs) and number of Member States (MSs) reporting information on cervical, breast, and colorectal cancer stage at diagnosis as well as other major chronic diseases
Amendment 1067 #
Proposal for a regulation Annex II – part B – point 7 7. Ratio of Cancer Registries (CRs) and number of Member States (MSs) reporting information on cervical, breast, and colorectal cancer stage at diagnosis as well as other major chronic diseases
Amendment 1068 #
Proposal for a regulation Annex II – part B – point 7 7. Ratio of Cancer Registries (CRs) and number of Member States (MSs) reporting information on cervical, breast, lung, blood, brain and colorectal cancer stage at diagnosis
Amendment 1069 #
Proposal for a regulation Annex II – part B – point 7 a (new) 7a. Ratio of palliative care admissions and outcome result for cancer and paediatric cancer
Amendment 1070 #
Proposal for a regulation Annex II – part B – point 8 8.
Amendment 1071 #
Proposal for a regulation Annex II – part B – point 8 8.
Amendment 1072 #
Proposal for a regulation Annex II – part 2 – point 8 a (new) 8a. Common and shared approach to notification, reporting and definition of shortages, reflecting the real impact on patients
Amendment 1073 #
Proposal for a regulation Annex II – part B – point 8 a (new) 8a. Percentage of adults (aged 18+) classified as overweight or obese
Amendment 1074 #
Proposal for a regulation Annex II – part 2 – point 8 a (new) 8a. Prevalence of overweight and obesity
Amendment 1075 #
Proposal for a regulation Annex II – part B – point 8 a (new) 8a. Prevalence of overweight and obesity
Amendment 1076 #
Proposal for a regulation Annex II – part B – point 8 a (new) 8a. Prevalence of overweight and obesity
Amendment 1077 #
Proposal for a regulation Annex II – part B – point 8 a (new) 8a. Prevalence of overweight and obesity
Amendment 1078 #
Proposal for a regulation Annex II – part 2 – point 8 a (new) 8a. Sexually transmitted infections
Amendment 1079 #
Proposal for a regulation Annex II – part B – point 8 a (new) 8a. Obesity prevalence
Amendment 1080 #
Proposal for a regulation Annex II – part B – point 8 b (new) 8b. Common and shared approach to shortages reporting, notification and definition, reflecting the real impact on patients
Amendment 1081 #
Proposal for a regulation Annex II – part B – point 8 b (new) 8b. Prevalence of major chronic diseases as defined by WHO
Amendment 1082 #
Proposal for a regulation Annex II – part B – point 9 9. Number of shortages of medicines in
Amendment 1083 #
Proposal for a regulation Annex II – part 2 – point 12 12. Deaths and diseases attributable to antimicrobial resistant infections
Amendment 1084 #
Proposal for a regulation Annex II – part B – point 12 a (new) 12 a. Quantity of antimicrobial use [by type and MS, separately for humans and animals]
Amendment 1085 #
Proposal for a regulation Annex II – part B – point 14 Amendment 1086 #
Proposal for a regulation Annex II – part B – point 14 a (new) 14a. ECDC reports on progress on elimination of viral hepatitis, HIV/ AIDS and Tuberculosis in line with WHO Strategies and UN SDGs
Amendment 1087 #
Proposal for a regulation Annex II – part B – point 14 a (new) 14a. Relative compliance with WHO air quality limits and environmental quality standards under EU water legislation
Amendment 1088 #
Proposal for a regulation Annex II – part 2 – point 14 a (new) 14a. Prevalence of major chronic diseases as defined by WHO
Amendment 1089 #
Proposal for a regulation Annex II – part B – point 14 a (new) 14a. Prevalence of major chronic diseases as defined by WHO
Amendment 1090 #
Proposal for a regulation Annex II – part B – point 14 a (new) 14a. Prevalence of major chronic diseases as defined by the WHO
Amendment 1091 #
Proposal for a regulation Annex II – part B – point 14 a (new) 14a. Number of health impact assessments of Union policies
Amendment 1092 #
Proposal for a regulation Annex II – part B – point 14 b (new) 14b. Avoidable deaths attributed to cardiovascular disease, cancer, diabetes & chronic respiratory disease for persons aged less than 75 years [SDG 3.4.1]
Amendment 1093 #
Proposal for a regulation Annex II – part B – point 14 c (new) 14c. Total alcohol per capita (age 15+ years) consumption [SDG 3.5.2]
Amendment 1094 #
Proposal for a regulation Annex II – part B – point 14 d (new) 14d. Screening coverage (by examination & invitation) for breast, cervical and colorectal cancer screening programmes
Amendment 1095 #
Proposal for a regulation Annex II – part B a (new) Ba. Age-standardized QALYs attributable to the NCDs (per 100 000 people), by disease, gender and age
Amendment 116 #
Proposal for a regulation Recital 3 (3) Article 168 TFEU provides that the Union is to complement and support national health policies, encourage cooperation between Member States, particularly in border regions, and promote the coordination between their programmes, in full respect of the responsibilities of the Member States for the definition of their health policies and the organisation and delivery of health services and medical care.
Amendment 117 #
Proposal for a regulation Recital 3 (3) Article 168 TFEU provides that the Union is to complement and support national health policies, encourage cooperation between Member States and promote the coordination between their programmes, in full respect of the responsibilities of
Amendment 118 #
Proposal for a regulation Recital 3 a (new) (3a) While the treaties oblige the EU to improve public health, preventing physical, and mental illness and diseases and obviating sources of danger to physical and mental health, the new and upcoming challenges, like COVID-19, have clearly shown that EU needs to take a stronger role ensuring the needed health policies are in place and health and wellbeing for its citizens because the Member States alone don´t have the adequate skills, capacities and resources to face the increasing and more complex health challenges.
Amendment 119 #
Proposal for a regulation Recital 3 a (new) (3a) In its communication of 20 October 2010 entitled ‘Solidarity in Health: Reducing Health Inequalities in the EU’, the Commission considered that there is a social gradient in health status in all the EU Member States. The World Health Organisation defines this social gradient as being the link between socioeconomic inequalities and inequalities in the areas of health and access to healthcare.
Amendment 120 #
Proposal for a regulation Recital 3 b (new) (3b) Health inequalities are rooted in social inequalities in terms of living conditions and models of social behaviour linked to gender, race, educational standards, employment, income and the unequal distribution of access to medical assistance, sickness prevention and health promotion services. The programme should facilitate the establishment of a common set of health determinants to monitor health inequalities by age, sex, socio-economic status and geographic location and introduce a methodology for auditing the health situation in Member States with the aim of identifying and prioritising areas in need of improvement and increased fundings. In its annual implementation assessment report, the Commission should evaluate the effectiveness of measures to reduce health inequalities resulting from policies relating to the social, economic and environmental risk factors. Through the allocation of fundings to the relevant regional and local stakeholders, the Programme should support a ‘local care approach’ to provide integrated healthcare, accessible at local or regional level, enabling patients to be better supported in their own local and social environment. The programme could also facilitate partnerships between border regions in order to share the cost of infrastructure and personnel and reduce inequalities with regard to health, particularly in respect of access to state- of-the-art equipment. The programme should therefore be implemented in close links with EU cohesion policy and structural funds.
Amendment 121 #
Proposal for a regulation Recital 4 a (new) (4a) Article 191 TFEU provides that the Union should contribute to protecting human health through a Union policy on the environment.
Amendment 122 #
Proposal for a regulation Recital 5 (5) On 11 March 2020 the World Health Organization (WHO)
Amendment 123 #
Proposal for a regulation Recital 5 (5) On 11 March 2020 the World Health Organization (WHO) declared the novel SARS-CoV-2 coronavirus and associated respiratory disease (COVID
Amendment 124 #
Proposal for a regulation Recital 5 (5) On 11 March 2020 the World Health Organization (WHO) declared the novel SARS-CoV-2 coronavirus and associated respiratory disease (COVID
Amendment 125 #
Proposal for a regulation Recital 5 (5) On 11 March 2020 the World Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a global pandemic. Th
Amendment 126 #
Proposal for a regulation Recital 5 (5) On 11 March 2020 the World Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a global pandemic. That pandemic has caused an unprecedented worldwide health
Amendment 127 #
Proposal for a regulation Recital 5 (5) On 11 March 2020 the World Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a global pandemic. That pandemic has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering, particularly affecting people with chronic conditions and hitting the most vulnerable, patients, women, carers and the elderly the hardest.
Amendment 128 #
Proposal for a regulation Recital 5 a (new) (5a) Women have been impacted disproportionately by the pandemic response measures and their long-term effects, must not compound existing inequities. Women across the lifespan remain under-represented in biomedical and health research and data. Consequently, the evidence base is weaker for women as well as for older people, many conditions are underdiagnosed in women, such as cardiovascular disease. Medicinal products are safer and more effective for everyone when clinical research studies include diverse population groups. To reduce inequalities and health disparities, sex and gender should be incorporated throughout the health process from design of clinical trial protocols, data analysis, health technology assessment and access to care.
Amendment 129 #
Proposal for a regulation Recital 5 a (new) (5a) On 11 March 2020 the World Health Organization (WHO) declared the novel SARS-CoV-2coronavirus and associated respiratory disease (COVID- 19) outbreak a global pandemic. That pandemic, and more specifically the severe acute respiratory disease causing both premature death and chronic lung conditions that it involves, has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering. The severity of the crisis demonstrates also the importance of Union action on the prevention and management of respiratory diseases.
Amendment 130 #
Proposal for a regulation Recital 5 a (new) (5a) According to the definition of the World Health Organisation (WHO), "Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." At this stage, the Union has not yet adopted a common definition of health. Following the COVID-19crisis. The Commission should propose a broader definition of the “public health” at European level.
Amendment 131 #
Proposal for a regulation Recital 5 b (new) Amendment 132 #
Proposal for a regulation Recital 6 (6)
Amendment 133 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is
Amendment 134 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Despite the reintroduction of internal borders at a time where solidarity between Member States was the most needed, several healthcare projects between cross-border regions, funded by Interreg programmes, have contributed to the fight against the COVID-19 crisis. Experience from the ongoing
Amendment 135 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity
Amendment 136 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8
Amendment 137 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8. Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States, as well as a permanent structured and coordinated dialogue between the authorities and the parties concerned, in order to improve the prevention and control of the spread of severe human diseases across borders, to combat other serious cross-
Amendment 138 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States to support rights- and evidence-based approaches with significant impact in order to improve the prevention and control of the spread of severe human diseases across borders, to develop and make available products for the prevention and treatment of diseases without discrimination, to combat other serious cross-
Amendment 139 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8. Experience
Amendment 140 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8
Amendment 141 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States, as well as a permanent structured and coordinated dialogue between authorities and relevant stakeholders, in order to improve the prevention and control of the spread of severe human diseases across borders, to combat other serious cross-
Amendment 142 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States, as well as a permanent structured and coordinated dialogue between authorities and relevant stakeholders, in order to improve the prevention and control of the spread of severe human diseases across borders, to combat other serious cross-
Amendment 143 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States, as well as a permanent structured and coordinated dialogue between authorities and relevant stakeholders, in order to improve the prevention and control of the spread of severe human diseases across borders, to combat other serious cross-
Amendment 144 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States and all relevant stakeholders, public, private and civil society, in a structured, regular, manner in order to improve the prevention and control of the spread of severe human diseases across borders, to combat other serious cross-
Amendment 145 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to
Amendment 146 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States
Amendment 147 #
Proposal for a regulation Recital 6 (6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8. Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States in order to improve the prevention and control of the spread of severe human diseases across borders, to combat other serious cross- border threats to health and to safeguard the health and well-being of people in the Union, regardless of where they are located, so that no one is overlooked. __________________ 8 Communication to the European Parliament, the European Council, the Council, the European Central Bank, the European Investment Bank and the Eurogroup on coordinated economic response to the COVID-19 outbreak, COM(2020)112 final of 13.03.2020.
Amendment 148 #
Proposal for a regulation Recital 6 a (new) (6a) While the Union´s action in the field of health is limited, the Union shall follow a coherent public health strategy in order to respond to existing epidemics taking into consideration regional and national specificities and have the capacity to face future worrying realities and health threats, such as pandemics and cross-border threats, including antimicrobial resistance and the health impacts of the climate crisis. The Union shall support Member States in reducing health inequalities and in achieving universal health coverage, addressing the challenges of an ageing population, of chronic diseases, or disease prevention, in promoting a healthy lifestyle, prevention services and preparing their health systems for emerging technologies.
Amendment 149 #
Proposal for a regulation Recital 6 a (new) (6a) While the Union´s action in the field of health is limited, the Union shall follow a coherent public health strategy in order face future worrying realities and health threats, such as pandemics and cross-border threats, including antimicrobial resistance and the health impacts of the climate crisis. The Union shall support Member States in reducing health inequalities and in achieving universal health coverage, addressing the challenges of an ageing population, of chronic diseases, or disease prevention, in promoting a healthy lifestyle, equal from a sex, gender and perspective to health and prevention services and preparing their health systems for emerging technologies.
Amendment 150 #
Proposal for a regulation Recital 6 a (new) (6a.) Although the Union’s action in the field of health is limited, it should have the ability to respond to future realities that may pose a threat to health, such as pandemics or antimicrobial resistance. It should also support the Member States in tackling the challenges of an ageing population, chronic diseases and the prevention of various age-related illnesses. Overall, priority should be given to promoting a healthy lifestyle. New technologies should also be introduced into the health systems.
Amendment 151 #
Proposal for a regulation Recital 6 a (new) (6a) While the Union´s action in the field of health is limited, the Union should have the capacity to face future worrying realities and health threats, such as pandemics and cross-border threats, antimicrobial resistance, and also to support Member States in addressing the challenges of an ageing population, of chronic diseases, or disease prevention, in promoting a healthy lifestyle, including a sex, gender and age perspective and preparing their health systems for emerging technologies.
Amendment 152 #
Proposal for a regulation Recital 6 a (new) (6a) The pandemic has revealed the importance of public health policies, and their benefits for citizens, communities and the economy. Such policies are cost- saving and offer returns in the long term of 14:1, meaning that for each euro invested in public health policies, we have economic return of 14 euros.
Amendment 153 #
Proposal for a regulation Recital 6 b (new) (6b) While the Union´s action in the field of health is limited, the Union should follow a coherent public health strategy in order to flexibly respond to existing epidemics taking into consideration local specificities and having the capacity to face future worrying realities and health threats, such as pandemics and cross- border threats, including antimicrobial resistance and the health impacts of the climate crisis. The Union should support Member States in reducing health inequalities and in achieving universal health coverage, addressing the challenges of an ageing population, of chronic diseases, of disease prevention, in promoting a healthy lifestyle and preparing their health systems for emerging technologies.
Amendment 154 #
Proposal for a regulation Recital 6 b (new) (6b) While the Union´s action in the field of health is limited, the Union should have the capacity to face future risks, realities and health threats, such as pandemics and cross-border threats, including antimicrobial resistance and environmental health threats, and also to support Member States in addressing the challenges of an ageing population, of chronic and rare diseases, or disease prevention, and preparing their health systems for emerging technologies in order to fully benefit from the digital revolution while seeking synergies with other relevant EU programmes such as Horizon Europe, Digital Europe, Connecting Europe Facility programme or Space Programme.
Amendment 155 #
Proposal for a regulation Recital 6 c (new) Amendment 156 #
Proposal for a regulation Recital 7 (7) It is therefore appropriate to establish a new Programme for the Union's action in the field of health, called EU4Health Programme ('the Programme') for the period 2021 -2027. In line with the goals of the Union action and its competences in the area of public health the Programme should place emphasis on actions in relation to which there are advantages and efficiency gains from collaboration and cooperation at Union level and actions with an impact on the internal market. The EU regulates products relevant to health and health outcomes including, amongst others, pharmaceuticals, medical devices, tobacco, alcohol, food and chemicals, therefore the Programme should take into consideration regulation in such areas to improve the health outcomes in the EU. A holistic approach is needed to improve health outcomes, and EU policy-makers should ensure that the principle of 'health in all policies' is applied in all policy- making.
Amendment 157 #
Proposal for a regulation Recital 7 (7) It is therefore appropriate to establish a new Programme for the Union's action in the field of health, called EU4Health Programme ('the Programme') for the period 2021 -2027. In line with the goals of the Union action and its competences in the area of public health the Programme should place emphasis on actions in relation to which there are advantages and efficiency gains from collaboration a
Amendment 158 #
Proposal for a regulation Recital 7 (7) It is therefore appropriate to establish a new Programme for the Union's action in the field of public health, called EU4Health Programme ('the Programme') for the period 2021 -2027. In line with the goals of the Union action and its competences in the area of public health the Programme should place emphasis on actions in relation to which there are advantages and efficiency gains from collaboration and cooperation at Union level and actions with an impact on the internal market.
Amendment 159 #
Proposal for a regulation Recital 9 (9) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Programme should be carried out to address the unprecedented impact of the COVID-19 crisis
Amendment 160 #
Proposal for a regulation Recital 9 (9) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Programme should be carried out to address the unprecedented impact of the COVID-19 crisis and ensure that resilient healthcare and health systems are in place in preparation for future pandemics and other health crises. Full advantage should be taken of the opportunities that digitalisation, artificial intelligence, robotics and new innovative technologies, in health and care can provide while ensuring the security of data, the right to privacy and data protection, while deploying adequate resources to ensure protection against cyber threats. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument].
Amendment 161 #
Proposal for a regulation Recital 9 (9) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Programme should be carried out
Amendment 162 #
Proposal for a regulation Recital 9 (9) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Programme should be carried out to address the unprecedented impact of the COVID-19 crisis and ensure that resilient and responsive healthcare and public health systems are in place in preparation for future pandemics and other health crises. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument].
Amendment 163 #
Proposal for a regulation Recital 9 (9) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Programme should be carried out to address the unprecedented impact of the COVID-19 crisis and ensure that resilient health care systems and services are in place. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument].
Amendment 164 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage
Amendment 165 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include creating strategic
Amendment 166 #
Proposal for a regulation Recital 10 (10) COVID-19 has demonstrated the inter-dependencies between human health and the health of our planet and our vulnerabilities. The emergence of zoonotic diseases which are transmitted from animals to humans is exacerbated by anthropogenic climate change, the destruction of biodiversity and environmental degradation. Due to the serious nature of cross-
Amendment 167 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include strategic stockpiling of essential medical supplies or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management
Amendment 168 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include creating strategic
Amendment 169 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthening the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the
Amendment 170 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address
Amendment 171 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level as well as at regional level between regions which share a common border to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include strategic stockpiling of essential medical supplies or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management and response capacity of actors at the Union, national, regional and local level, including contingency planning and preparedness exercises, in keeping with the “One Health” approach. It should facilitate the setting up of an integrated cross-cutting risk communication framework working in all phases of a health crisis - prevention, preparedness and response. __________________ 10Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 172 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage
Amendment 173 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include strategic, EU financed and coordinated, stockpiling of essential medical supplies or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management and response capacity of actors at the Union, national, regional and local level, including contingency planning and preparedness exercises, in keeping with the “One Health” approach. It should facilitate the setting up of an integrated cross-cutting risk communication framework working in all phases of a health crisis - prevention, preparedness and response. __________________ 10Decision No 1082/2013/EU of the European Parliament and of the Council of
Amendment 174 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include strategic
Amendment 175 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthening the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council
Amendment 176 #
Proposal for a regulation Recital 10 (10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include strategic
Amendment 177 #
Proposal for a regulation Recital 10 a (new) (10a) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices and personal protective equipment needed in the Union during the pandemics. In the event of health crises and pandemics, but also for recurrent shortages, the Programme should promote actions that encourage the production, purchase and management of relevant products by ensuring that they complement other EU instruments.
Amendment 178 #
Proposal for a regulation Recital 10 a (new) (10a) To combat serious threats to the health of European citizens we need to establish communicable diseases regulation. Communicable diseases move freely within whole EU. In more complex and globalised world, the ability to respond to the challenges clearly requires a common regulation to face and tackle the border crossing diseases on EU level. Individual Member States cannot face these global challenges alone.
Amendment 179 #
Proposal for a regulation Recital 10 a (new) (10a) Given the impact that the COVID- 19 crisis had on access to healthcare services, which may not be directly related to the treatment of COVID-19 infections but remain essential healthcare services, including sexual and reproductive healthcare services, the Programme should respond to health crises in a holistic manner and support actions that aim to guarantee access to all essential healthcare services.
Amendment 180 #
Proposal for a regulation Recital 11 (11)
Amendment 181 #
Proposal for a regulation Recital 11 (11)
Amendment 182 #
Proposal for a regulation Recital 11 (11) As in the time of health crisis emergency health technology assessment as well as clinical trials can contribute to the rapid development of medical countermeasures the Programme should provide support to facilitate such actions. The Commission has adopted a proposal11 on
Amendment 183 #
Proposal for a regulation Recital 11 (11) As in the time of health crisis emergency health technology assessment as well as clinical trials can contribute to the rapid development of medical countermeasures the Programme should provide support to facilitate such actions. The Commission has adopted a proposal11
Amendment 184 #
Proposal for a regulation Recital 12 (12) With a view to protect people in vulnerable situations, including those suffering from mental illnesses, living with or most affected by communicable or non- communicable diseases and chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups, including improving health literacy and supporting patient advocacy groups. With a view to guaranteeing continued high standards of essential healthcare services, including prevention, the Programme should, in particular in times of crisis and pandemics, encourage a transition to accessible and affordable telemedicine, at-home administration of medication and implementation of preventative and self-care plans, where possible and appropriate, while ensuring that access to healthcare and prevention services is provided to chronic patients and patients at risk. The Programme should also ensure that the transition is based on evidence and evaluation of best practices, supported by adequate systems of information and health literacy, infrastructures and careful planning, taking into consideration issues such as access to digital solutions in remote areas or for specific population groups.
Amendment 185 #
Proposal for a regulation Recital 12 (12) With a view to protect people in vulnerable situations, including those suffering from mental illnesses, non- communicable diseases and chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups.
Amendment 186 #
Proposal for a regulation Recital 12 (12) With a view to protect people in vulnerable situations,
Amendment 187 #
Proposal for a regulation Recital 12 (12) With a view to protect people in vulnerable situations, including
Amendment 188 #
Proposal for a regulation Recital 12 (12) With a view to protect people in vulnerable situations, including those suffering from mental illnesses and chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups as well as the varying impacts in terms of gender. With a view to guaranteeing continued high standards of essential healthcare services, the Programme should, in particular in times of crisis and pandemics, encourage a transition to telemedicine taking account of varying levels of digital literacy, at-home administration of medication, promote innovative digital solutions for health and care in synergy with Horizon Europe and its relevant Missions and Partnerships and implementation of preventative and self-care plans, where possible and appropriate, while ensuring that access to healthcare services is provided to chronic patients, .
Amendment 189 #
Proposal for a regulation Recital 12 (12) With a view to protecting people in vulnerable situations, including those
Amendment 190 #
Proposal for a regulation Recital 12 (12) With a view to protect people in vulnerable situations, including those suffering from mental illnesses and chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups. With a view to guaranteeing continued high standards of essential healthcare services, the Programme should, in particular in times of crisis and pandemics, encourage a transition to accessible and affordable telemedicine, at- home administration of medication and implementation of preventative and self- care plans, where possible and appropriate, while ensuring that access to healthcare and prevention services is provided to chronic patients and patients at risk.
Amendment 191 #
Proposal for a regulation Recital 12 (12) With a view to protect
Amendment 192 #
Proposal for a regulation Recital 12 (12) With a view to protect people in vulnerable situations, including those suffering from mental illnesses and chronic
Amendment 193 #
Proposal for a regulation Recital 12 (12) With a view to protect
Amendment 194 #
Proposal for a regulation Recital 12 a (new) (12a) Article 8 TFEU gives the Union the task of eliminating inequalities and promoting equality between men and women in all of its activities. The principle of gender mainstreaming should be applied to all activities implemented through this Programme, and this Programme should contribute to achieving the common objectives set out in the Council conclusions on women's health of 22 June 2006. This Programme should support actions which promote gender mainstreaming in healthcare, address women’s specific health needs as some health issues affect women exclusively or disproportionately, including sexual and gender-based violence as well as certain aspects of sexual and reproductive health, address gender aspects of health including sexual and reproductive health and rights as committed to in the Gender Equality Strategy, aim to reduce gender inequalities in health recognizing gender as a key determinant of health, collect disaggregated and gender-specific data on the status of women’s health to measure women’s unmet medical needs, and provide gender-sensitive health information, education and promotion, prevention measures and treatment.
Amendment 195 #
Proposal for a regulation Recital 12 a (new) (12a) The right to physical and mental health is a fundamental human right. Every person, without discrimination, has the right to access modern and comprehensive healthcare. The EU4Health programme should guarantee that universal health coverage is provided, in line with the international commitments made through SDGs and with WHO policies, and ensure that everyone can use the health services they need without experiencing financial hardship. To continue being a global leader in health and to provide a high standard healthcare across the Union, the Commission should propose a Directive on minimum standards for quality healthcare with a set of criteria that should be reported by Member States, such as hospital beds per capita, critical care capacities, numbers of doctors and nurses per capita, rate of health expenditure and access and affordability of healthcare for all, including for vulnerable people. This would improve patient safety and result in better conditions in healthcare for patients and professionals.
Amendment 196 #
Proposal for a regulation Recital 12 a (new) (12a) Demographic change and technological innovation are some of the most important challenges facing our health systems. The aging of the population is largely due to the success of our healthcare systems and forces them, at the same time, to a structural transformation: from a healthcare model focused mainly on acute diseases, it is necessary to move towards a healthcare model in which chronic diseases gain more weight. It is important that the Member States accompany each other in this process of transformation of the healthcare model, and for this reason it is necessary to strengthen good practices exchanging mechanisms. TheEU4Health programme should play an important role in guiding these exchanges.
Amendment 197 #
Proposal for a regulation Recital 12 a (new) (12a) Correlations have been observed between health and/or economic crises and a worrying increase in depressive tendencies resulting from the effects of reduced disposable income, uncertainty about the future and growing unemployment. The Programme should therefore provide support for national actions aimed at integrating mental health into all policies and promoting mental health in all areas, including school and work, and for preventive actions to combat depression and suicide.
Amendment 198 #
Proposal for a regulation Recital 13 (13) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices as well as personal protective equipment
Amendment 199 #
Proposal for a regulation Recital 13 (13) The COVID-19 crisis has highlighted many challenges in
Amendment 200 #
Proposal for a regulation Recital 13 (13) The COVID-19 crisis has highlighted
Amendment 201 #
Proposal for a regulation Recital 13 (13) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices, active pharmaceutical ingredients, as well as personal protective equipment needed in the Union during the pandemics. The Programme therefore should provide support to actions which foster the production, procurement and management of crisis relevant products ensuring complementarity with other Union instruments. Upgradable and scalable manufacturing capacity of medicines within European Union should be achieved, to avoid the hindrances in medicine circulation and shortages in supply.
Amendment 202 #
Proposal for a regulation Recital 13 (13) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices as well as personal protective equipment needed in the Union during the pandemics noting, in particular, its dependency on third countries for manufacturing capacity, the supply of active pharmaceutical ingredients and starting materials. The Programme therefore should provide support to actions which foster the production, procurement and management of crisis relevant products ensuring complementarity with other Union instruments.
Amendment 203 #
Proposal for a regulation Recital 13 (13) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices as well as personal protective equipment needed in the Union during the pandemics. The Programme therefore should provide support to actions, which foster the production, procurement and management of
Amendment 204 #
Proposal for a regulation Recital 13 (13) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices as well as personal protective equipment needed in the Union during the pandemics. The Programme therefore should provide support to actions which foster the production, procurement
Amendment 205 #
Proposal for a regulation Recital 14 (14) In order to minimise the public health consequences of serious cross- border threats to health it should be possible for actions supported under the Programme to cover coordination of the activities which strengthen the interoperability and coherence of Member States’ health-systems through benchmarking, cooperation and exchange of best practices and ensure their capability to respond to health emergencies, that includes contingency planning, preparedness exercises and the upskilling of health care and public health staff and the establishment of mechanisms for the efficient monitoring and needs-driven distribution or allocation of goods and services needed in time of crisis. The benchmarking, cooperation and exchange of best practices should be equally promoted in periods where there are no crises.
Amendment 206 #
Proposal for a regulation Recital 14 (14) In order to minimise the public health consequences of serious cross- border threats to health it should be possible for actions supported under the Programme to cover coordination of the activities which strengthen the interoperability and coherence of Member States’ health-systems through benchmarking, cooperation and exchange of best practices and ensure their capability to respond to health emergencies, that includes contingency planning, preparedness exercises and the upskilling of health care and public health staff and the establishment of mechanisms for the efficient monitoring and needs-driven distribution or allocation of goods and services needed in time of crisis, which would be particularly beneficial in a cross-border context.
Amendment 207 #
Proposal for a regulation Recital 14 (14) In order to minimise the public health consequences of serious cross- border threats to health it should be possible for actions supported under the Programme to cover coordination of the activities which strengthen the interoperability and coherence of Member States’ health-systems through benchmarking, cooperation and exchange
Amendment 208 #
Proposal for a regulation Recital 14 a (new) Amendment 209 #
Proposal for a regulation Recital 14 a (new) (14a) The COVID-19 crisis has revealed the important need for Member States to organize stress tests to assess the resilience of their national health systems to all types of crises. These tests must be carried out on the basis of precise evaluation criteria set by the European Commission. The results of these tests could determine the weaknesses of the national health systems and the areas to be the subject to specific financial support.
Amendment 210 #
Proposal for a regulation Recital 14 b (new) (14b) The coordination between national health systems is essential to guarantee solidarity within the Union. Joint procurement, coordinated transfer of equipment, reserve and circulation of blood products and organs, transports of patients for cross-border care should be adequately anticipated.
Amendment 211 #
Proposal for a regulation Recital 14 c (new) (14c) In addition to an increased budget, the EU Civil Protection Mechanism (UCPM) and its instrument RescEU should be strengthened to ensure a truly common, coordinated and effective response at EU level.
Amendment 212 #
Proposal for a regulation Recital 14 d (new) (14d) The Union should be able to rely on the mobilization of health professionals through the “European Medical Corps” created to enable quick medical assistance and public health expertise to all Member States.
Amendment 213 #
Proposal for a regulation Recital 14 e (new) (14e) European health agencies, in particular the ECDC and the EMA should be granted strengthened competences, resources and personnel to allow them to better and quicker carry out their duties efficiently to the benefit of European citizens. To anticipate any types of crises, the Commission should also evaluate the needs of the other European health agencies such as EFSA, ECHA and EU- OSHA. A stronger coordination between European Agencies should be guaranteed by the Commission.
Amendment 214 #
Proposal for a regulation Recital 14 f (new) (14f) The Programme should support the revision of ECDC’s mandate to extend its competencies to the chronical diseases, to elaborate mandatory guidances for Member States and to be able to coordinate laboratory research in times of health crises.
Amendment 215 #
Proposal for a regulation Recital 14 g (new) (14g) The programme should also support the revision of the EMA’s mandate to extend its competencies on clinical trial’s coordination and management of the shortages of medicines. EMA could therefore meet any future challenges such as monitoring and responding to shortages in coordination with the Member States. In the long term, EMA should be able to make conditional marketing authorizations upon guarantees of supply and accessibility from manufacturers. The reinforcement of the EMA’s personnel should enable the Agency to carry out inspections of production sites established in third countries.
Amendment 216 #
Proposal for a regulation Recital 14 h (new) (14h) In order to facilitate EU Joint Procurement procedures, the Commission could adopt a specific legislation to promote their use to buy vaccines and treatments, to guarantee the efficiency and the transparency of the process and to ensure an equal access to medicines, medical devices, protective equipment and other relevant health products. A part of the medical products purchased via the EU joint procurement procedure could constitute a European contingency reserve of medical products subjected to shortages.
Amendment 217 #
Proposal for a regulation Recital 14 i (new) (14i) The establishment of a communication portal for the public would allow the Union to share validated information, send alerts to European citizens and fight against disinformation. It could include a wide range of information, prevention campaigns and youth education programs. This portal could also be used to promote, in cooperation with the ECDC, a strong immunization coverage at European level.
Amendment 218 #
Proposal for a regulation Recital 14 j (new) (14j) A digital exchange platform, such as the COVID-19 Data Portal, could facilitate exchanges on epidemiological data, science-based practice recommendations to health professionals and hospitals, and the exact state of mobilizable capacities and medical products stocks.
Amendment 219 #
Proposal for a regulation Recital 15 (15) Experience from the COVID-19 crisis has indicated that there is a general need for the support to structural transformation of and systemic reforms of health systems across the Union to improve their effectiveness, accessibility, sustainability and resilience. In the context of such transformation and reforms, the Programme should promote, in synergy with the Digital Europe Programme,
Amendment 220 #
Proposal for a regulation Recital 15 (15) Experience from the COVID-19 crisis has indicated that there is a general need for the support to structural transformation of and systemic reforms of health systems across the Union to improve their effectiveness, accessibility and resilience. In the context of such transformation and reforms, the Programme should promote, in synergy with the Digital Europe Programme, actions which advance digital transformation of health services and increase their interoperability, contribute to the increased capacity of health systems to foster disease prevention and health promotion, to provide new care models and to deliver integrated services, from the community and primary health care to the highly specialised services, based on people's needs, taking an intersectional and gender-sensitive approach to address social determinants of health and differential vulnerabilities leading to inequitable health outcomes, and ensure an efficient public health workforce equipped with the right skills, including digital skills. The development of a European health data space would provide health care systems, researchers and public authorities with
Amendment 221 #
Proposal for a regulation Recital 15 (15) Experience from the COVID-19 crisis has indicated that there is a general need for the support to structural transformation of and systemic reforms of health systems across the Union to improve their effectiveness, accessibility and resilience. In the context of such transformation and reforms, the Programme should promote, in synergy with the Digital Europe Programme, actions which advance digital transformation of health services and increase their interoperability, contribute to the increased capacity of health systems to foster disease prevention and health promotion, to provide new care models and to deliver integrated services , from the community and primary health care to the highly specialised services, based on people's needs and ensure an efficient public health workforce equipped with the right skills, including digital skills. The
Amendment 222 #
Proposal for a regulation Recital 15 (15) Experience from the COVID-19 crisis has indicated that there is a general need for the support to structural transformation of and systemic reforms of health systems across the Union to improve their effectiveness, accessibility and
Amendment 223 #
Proposal for a regulation Recital 15 (15) Experience from the COVID-19 crisis has indicated that there is a general need for the support to structural transformation of and systemic reforms of health systems across the Union to improve their effectiveness, accessibility and resilience. In the context of such transformation and reforms, the Programme should promote, in synergy with the Digital Europe Programme, actions which advance digital transformation of health services and increase their interoperability, contribute to the increased capacity of health systems to foster disease prevention and health promotion, to provide new care models and to deliver integrated services, from the community and primary health care to the highly specialised services, based on people's needs and ensure an efficient public health workforce equipped with the right skills, including digital skills. The development of a European health data space and of a European Electronic Health Record would provide health care systems, researchers and public authorities with means to improve the availability and quality of healthcare. Such European Health Record should be standardised, interoperable with different health data systems and accessible for the patients in all Member States with privacy ensured and information encoded into the European Health Insurance Card, EHIC. Given the fundamental right to access to preventive health care and medical treatment enshrined in Article 35 of the Charter of Fundamental Rights of the European Union
Amendment 224 #
Proposal for a regulation Recital 15 (15) Experience from the COVID-19 crisis has indicated that there is a general need for the support to structural transformation of and systemic reforms of health systems across the Union to improve their effectiveness, accessibility and
Amendment 225 #
Proposal for a regulation Recital 15 (15) Experience from the COVID-19 crisis has indicated that there is a general need for the support to structural transformation of and systemic reforms of health systems across the Union to improve their effectiveness, accessibility and resilience. In the context of such transformation and reforms, the Programme should promote, in synergy with the Digital Europe Programme, actions which advance digital transformation of health services and increase their interoperability, contribute to the increased capacity of health systems to foster disease prevention and health promotion, to provide new care models, to progress deinstitutionalisation and move towards community-based care including for older people, and to deliver integrated services, from the community and primary health care to the highly specialised services, based on people's needs and ensure an efficient public health workforce equipped with the right skills, including digital skills. The development of a European health data space would provide health care systems, researchers and public authorities with means to improve the availability and quality of healthcare. Given the fundamental right to access to preventive healthcare and medical treatment enshrined in Article 35 of the Charter of Fundamental Rights of the European Union and in view to the common values and principles in
Amendment 226 #
Proposal for a regulation Recital 15 (15) Experience from the COVID-19 crisis has indicated that there is a general need for the support to structural transformation of and systemic reforms of health systems across the Union to improve their effectiveness, accessibility and resilience. In the context of such transformation and reforms, the Programme should promote, in synergy with the Digital Europe Programme, actions which advance digital transformation of health services and increase their interoperability, contribute to the increased capacity of health systems to foster disease prevention and health promotion, to provide new care models and to deliver integrated services, from the community and primary health care to the highly specialised services, based on people's needs and ensure an efficient
Amendment 227 #
Proposal for a regulation Recital 15 a (new) (15a) The COVID-19 situation has taught us the importance of health as a public good which needs to be preserved by developing coherent approaches to tackle chronic conditions, be they communicable or non-communicable, and by exploiting synergies in approaching people at risk. The COVID- 19 situation has also highlighted the imperative to generate and share reliable data on diagnosis, treatment and cure via the ECDC across the EU. It has also confirmed the need to apply innovative solutions to identify people at risk of having an infectious disease, so they can be tested, linked to care and take precautions to prevent further transmissions, leading to disease elimination. Notwithstanding the differences in transmission routes, these learnings also apply to viral hepatitis, where the ECDC report from May 2020 which monitors progress towards the elimination of hepatitis B and C in the EU/EEA highlights that “hepatitis related mortality is high in the region and there is very little evidence of progress towards the 2030 elimination target of a 65% reduction in mortality against the 2015 baseline". The ECDC report thus confirms that, unless the EU drives forward the prevention of transmission, diagnosis and linkage to care, Europe will fail to meet the WHO elimination target and will fail to deliver on its commitment to the UN SDG.
Amendment 228 #
Proposal for a regulation Recital 15 a (new) (15a) The value of health data is essential for having more reliable information to improve healthcare services, health policy-making and to evaluate the implementation of actions and policies in our society. The European Health Data Space will represent a strong pillar of health in the Union and should be constructed involving all sectors and stakeholders, taking into account the needs of health professionals and patient. The Programme should capacitate and enlarge the competence of the ECDC to improve the capacity of surveillance of NCDs. The European Health Data should collect data on healthcare use, health behaviour and health problems, including information on rare diseases, vaccination, allergies and others.
Amendment 229 #
Proposal for a regulation Recital 15 a (new) (15a) Effective use of Information Technology systems, including AI, in full respect of EU data protection and privacy legal framework, is key to improve regulatory efficiency across Europe; it is also necessary to optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and interdependency of the European regulatory framework, and to ensure a fit for purpose regulatory environment that is a key element to protect public health, provide access to high quality medicines and contribute to the prevention of shortages.
Amendment 230 #
Proposal for a regulation Recital 15 a (new) (15a) A regulation on patient's rights is needed to ensure the right to accessible, affordable and high quality patient- centred health care, including relevant, appropriate and value based medicinal care, right to affordable, effective medication, rehabilitation and support for care. The right to cross-border health care and adequate support services should be guaranteed. Patients' right to second opinions should also be ensured.
Amendment 231 #
Proposal for a regulation Recital 15 a (new) (15a) The programme should support innovations in the digitalization area that could bring concrete benefits to patients and healthcare professionals and provide cost-effective high-quality healthcare whilst reducing inequalities. Important steps could be taken in digital skills, both for healthcare professionals and patients training, especially in rural and sparsely populated areas.
Amendment 232 #
Proposal for a regulation Recital 15 b (new) (15b) Generating and sharing reliable data on health systems’ management of communicable diseases is essential to track the progress made and tailor national and local systems’ responses across Europe in a coordinated manner. The Programme should therefore support the upscaling of the ECDC’s competence and resources in monitoring health care systems’ responses to transmittable diseases, including HIV, TB and viral hepatitis. In particular, additional resources should be channelled to support the creation of EU-wide databases, with the aim to provide an overview of the existing gaps in the continuum of care. EU-wide data sharing should also help monitor the management of such conditions in the long-term and from a holistic perspective, including the management of relevant comorbidities and the overall progress of the system in improving the health-related quality of life of patients.
Amendment 233 #
Proposal for a regulation Recital 15 b (new) (15b) It is important to guarantee equal access for patients in different Member States to effective therapeutics, treatments and prevent individual health care units from excessive and unreasonable costs when treating rare diseases. The Commission should therefore explore the possibility to establish a European fund, co-financed by the Member States, for negotiating and purchasing the orphan medicines and other new, personalised and experimental medication.
Amendment 234 #
Proposal for a regulation Recital 15 b (new) (15b) The programme should facilitate the reinforcement of e-health and m- health as well as the use of telemedicine and remote monitoring of patients, especially in times of sanitary crises.
Amendment 235 #
Proposal for a regulation Recital 15 c (new) (15c) Ensuring a fit for purpose regulatory environment is a key element to protect public health, provide access to high quality medicines and contribute to the prevention of shortages. The effective use of Information Technology systems will improve regulatory efficiency across Europe; it is important therefore to optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and interdependency of the European regulatory framework.
Amendment 236 #
Proposal for a regulation Recital 16 (16) Keeping people healthy and active longer and empowering them to take an active role in managing their health will have positive effects on health, health inequalities, quality of life, productivity, competitiveness and inclusiveness, while reducing pressures on national budgets. Furthermore, to ensure optimal efficiency of the programme, state paternalism must be accompanied by the conceptualisation of health as a mutual responsibility of both the citizens and state authorities, as health is a partnership that both imposes obligations and confers rights. In developing health education, the programme will have even greater success if it can enhance citizens’ ability to play an active role in managing their own personal health. It is crucial to strengthen medical autonomy in order to better manage self-care. All of the parties concerned have equal responsibility, including the general public, patients, medical professionals, trainers, administrators, researchers, governments, including legislative and regulatory bodies, professional associations, and certification bodies. The Commission has committed to help Member States to reach the sustainable development targets set in the ‘UN 2030 Agenda for Sustainable Development’ in particular Sustainable Development Goal 3 ‘Ensure healthy lives and promote well-
Amendment 237 #
Proposal for a regulation Recital 16 (16) Keeping people healthy and active longer and empowering them to take an active role in managing their health will have positive effects on health, health inequalities, quality of life, productivity, competitiveness and inclusiveness, while reducing pressures on national budgets. Recognition of innovation, which has a profound impact on health outcomes and costs, also serves to address the challenges of achieving sustainability in the health sector and the impact of changing demographics. Moreover, action to reduce inequalities in the provision of healthcare in rural and remote areas is important for the purposes of achieving inclusive growth. The Commission has committed to help Member States to reach the sustainable development targets set in the 'UN 2030 Agenda for Sustainable Development’ in particular Sustainable Development Goal 3 "Ensure healthy lives and promote well-
Amendment 238 #
Proposal for a regulation Recital 16 (16) Health is an investment and the Programme should have this concept at its core. Keeping people healthy and active longer and empowering them to take an active role in managing their health through health literacy in order to take well informed decisions, will have positive effects on health, health inequalities, health iniquities, quality of life, productivity, competitiveness and inclusiveness, while reducing pressures on national health systems and budgets. The Commission has committed to help Member States to reach the sustainable development targets set in the 'UN 2030 Agenda for Sustainable Development’ in particular Sustainable Development Goal 3 "Ensure healthy lives and promote well- being for all at all ages"13. The Programme therefore should contribute to the actions taken towards reaching the SDGs
Amendment 239 #
Proposal for a regulation Recital 16 (16) Keeping people healthy and active longer and empowering them to take an active role in managing their health, by improving their health literacy, will have positive effects on health, health inequalities, quality of life, productivity, competitiveness and inclusiveness, while reducing pressures on national budgets. The Commission has committed to help Member States to reach the sustainable development targets set in the 'UN 2030 Agenda for Sustainable Development’ in particular Sustainable Development Goal 3 "Ensure healthy lives and promote well- being for all at all ages".13 The Programme therefore should contribute to the actions taken towards reaching these goals, for e.g. by recognizing the strategic role of health literacy in managing personal health. __________________ 13Communication from the Commission to the European Parliament, the Council, the
Amendment 240 #
Proposal for a regulation Recital 16 a (new) (16a) We now know that social and economic determinants are a persistent source of inequalities in health. One of the priority objectives of Member States' public health systems should be the fight against these inequalities. The COVID- 19pandemic has threatened the European population as a whole, but once again the most economically vulnerable populations have been the most affected. It is essential that the projects of the EU4Health programme are managed in accordance with the general and transversal objective of reducing health inequalities. Likewise, the EU4Health programme's projects should also serve to assist Member States in the reformulation of the budgets of their health systems, with the aim of making them more clearly redistributed according to the criteria of health inequalities of the population.
Amendment 241 #
Proposal for a regulation Recital 16 a (new) (16a) The Programme should provide for equal access to healthcare. ‘Socioeconomic health inequalities’ cover situations ranging from unequal access to treatment, fragmented access across regions and differences in health status based on economic conditions, to the distribution of health determinants between different population groups. The individual Member States are responsible for developing social and health polices to tackle the national challenges linked to health inequalities.
Amendment 242 #
Proposal for a regulation Recital 16 a (new) (16a) The Programme should provide for equal and fair access to healthcare. “Health inequalities” cover situations ranging from unequal access to treatment, fragmented access across regions, differences in health status origin, and to the distribution of health determinants between different population groups. Health inequalities and inequities are avoidable by reasonable means, and thus preventable, and the Programme should improve the knowledge on health inequalities and inequities to tackle them.
Amendment 243 #
Proposal for a regulation Recital 16 a (new) (16a) The Programme should provide for equal access to healthcare. “Health inequalities” cover situations ranging from unequal access to prevention, treatment, fragmented access across regions, differences in health status origin, and to the distribution of health determinants between different population groups. Health inequalities are avoidable by reasonable means, and thus preventable.
Amendment 244 #
Proposal for a regulation Recital 16 a (new) (16a) Gender and sex sensitivity and knowledge needs to be improved in the education of health care professionals, the research, diagnosis, treatment and impact of medicines and therapeutics to better understand and treat both sexes.
Amendment 245 #
Proposal for a regulation Recital 16 b (new) (16b) Training for health care professionals and specialised health care facilities needs to be provided so that the needs of groups such as LGBTIQ, Roma and other groups with special needs can be met.
Amendment 246 #
Proposal for a regulation Recital 16 c (new) (16c) The programme should provide easy access to basic healthcare to all. Low-threshold guidance, counselling, and access to preventive health care should be available to all citizens. Family doctor system for necessary health checks to provide preventive healthcare should be promoted. Adequacy of this capacity should be monitored in the European Semester.
Amendment 247 #
Proposal for a regulation Recital 17 (17) Non-communicable diseases are a result of commercial determinants of health a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases,
Amendment 248 #
Proposal for a regulation Recital 17 (17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and
Amendment 249 #
Proposal for a regulation Recital 17 (17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes, represent major causes of disability, ill-health, health- related retirement, and premature death in the Union, resulting in considerable social and economic impacts. To decrease the impact of non-communicable diseases on
Amendment 250 #
Proposal for a regulation Recital 17 (17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors and commercial determinant of health. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes, represent major causes of disability, ill-health, health- related retirement, and premature death in the Union, resulting in considerable social and economic impacts. To decrease the impact of non-communicable diseases on individuals and society in the Union and reach goal 3 of the Sustainable Development Goals, Target 3.4, to reduce premature mortality from non- communicable diseases by one third by 2030, it is key to provide an integrated response focusing on prevention across sectors and policy fields, promotion of a healthy lifestyle combined with efforts to strengthen health systems.
Amendment 251 #
Proposal for a regulation Recital 17 (17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, rare diseases and diabetes represent major causes of disability, ill- health, health-
Amendment 252 #
Proposal for a regulation Recital 17 (17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, obesity, chronic respiratory diseases,
Amendment 253 #
Proposal for a regulation Recital 17 (17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, neurological disorders, chronic respiratory diseases, and diabetes, represent major causes of disability, ill- health, health-
Amendment 254 #
Proposal for a regulation Recital 17 (17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases,
Amendment 255 #
Proposal for a regulation Recital 17 (17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, neurological disorders, chronic respiratory diseases, and diabetes, represent major causes of disability, ill- health, health-
Amendment 256 #
Proposal for a regulation Recital 17 (17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, neurological disorders, chronic respiratory
Amendment 257 #
Proposal for a regulation Recital 17 (17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes, represent major causes of disability, ill-health, health- related retirement, and premature death in the Union, resulting in considerable affective, social and economic impacts. To decrease the impact of non-communicable diseases on individuals and society in the Union and reach goal 3 of the Sustainable
Amendment 258 #
Proposal for a regulation Recital 17 a (new) (17a) Chronic diseases develop slowly, are long-lasting and often incurable. Chronic disease patients often live with several comorbidities, which makes it complex to treat and manage them. The Union and the Member States can greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines, such as cardiovascular disease, neurodegenerative diseases, respiratory diseases and diabetes. Moreover, a significant proportion of chronic diseases are preventable by addressing major risk factors such as tobacco use, unhealthy diets, physical inactivity and air quality. Chronic diseases develop slowly, are long-lasting and often incurable. Chronic disease patients often live with several comorbidities, which makes it complex to treat and manage them. The Union and the Member States can greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines, such as cardiovascular disease, neurodegenerative diseases, respiratory diseases and diabetes. Moreover, a significant proportion of chronic diseases are preventable by addressing major risk factors such as tobacco use, unhealthy diets, physical inactivity and air quality.
Amendment 259 #
Proposal for a regulation Recital 17 a (new) (17a) Prevention and health promotion are key in achieving sustainable health systems by ensuring that citizens live disease-free longer and by reducing the pressure of preventable diseases, especially of non-communicable diseases, on health systems. In order to enhance the health status and quality of life of Union citizens, primary care healthcare professionals, including community pharmacists, and community groups should be involved in raising public health awareness, participating in disease prevention and control. The Programme should support Union actions and support Member States in developing and implementing prevention and health promotion, early diagnosis and screening strategies. This includes healthy public policies, community action for health, supportive environments and reorienting disease prevention services as part of primary health care services towards health promotion. Screening programmes need to be evidence-based and avoid adverse effects and unnecessary burden on health services.
Amendment 260 #
Proposal for a regulation Recital 17 a (new) (17a) Chronic diseases develop slowly, are long-lasting and often incurable. Chronic disease patients often live with several comorbidities, which makes it complex to treat and manage them. The Union and the Member States can greatly reduce the burden on Member States by working together to achieve a better and more effective management of diseases, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines, for diseases such as cardiovascular disease, neurodegenerative diseases, respiratory diseases, obesity and diabetes. In making these guidelines, special attention should be given to major risk factors such as tobacco use, alcohol consumption, unhealthy diet, physical inactivity and air quality.
Amendment 261 #
Proposal for a regulation Recital 17 a (new) (17a) Communicable diseases such as HIV/AIDS, tuberculosis and viral hepatitis have a social dimension that needs to be addressed in a multidisciplinary manner. They should be tackled not only with antivirals and vaccines, but also with education, information, and appropriate social and psychological measures. This approach is well understood for problems such as drug or alcohol addiction. To this end, it is essential to invest in innovative community-based approaches to communicable disease control and prevention strategies for sexually transmitted infections.
Amendment 262 #
Proposal for a regulation Recital 17 a (new) (17a) The role of primary prevention and health promotion is key to address long term, common European challenges such as non-communicable and communicable diseases, ageing and cross- border health threats such as future pandemics, antimicrobial resistance. The Union can bring additional added-value to offer an overall public health strategy based on identified best practices and the European dimension of identified health challenges in the area of access to healthcare, health prevention and promotion in order to reduce health inequalities and health differences in Europe.
Amendment 263 #
Proposal for a regulation Recital 17 a (new) (17a) Early detection and screening of non-communicable diseases, such as heart diseases, plays a crucial role in all treatment and prevention strategies. The Programme should support Union actions and support Member States in developing and implementing prevention, early diagnosis and screening strategies. Joint Actions and similar initiatives with the goal of improving early detection, especially of non-communicable diseases such as Structural Heart Disease, are strongly encouraged.
Amendment 264 #
Proposal for a regulation Recital 17 a (new) (17a) Mental and psychological well- being is crucial for good mental health. The Programme should be aimed at improving the mental health of individuals and society, including the promotion of mental well-being, the prevention of mental disorders, the protection of human rights and the care of people affected by mental disorders and neurological diseases.
Amendment 265 #
Proposal for a regulation Recital 17 a (new) (17a) In the implementation of those prevention, vaccination, early diagnosis and screening strategies, it is imperative that the Programme exploit synergies with the ESF+ and other programmes.
Amendment 266 #
Proposal for a regulation Recital 17 b (new) (17b) Early detection and screening plays a crucial role in all treatment and prevention strategies. Prevention is key in achieving sustainable health systems by ensuring that citizens live disease-free longer and by reducing the pressure of preventable diseases, especially of non- communicable diseases, on health systems. In order to enhance the health status and quality of life of Union citizens, primary care healthcare professionals, including community pharmacists, should be involved in raising public health awareness, participating in disease prevention and control. The Programme should support Union actions and support Member States in developing and implementing prevention, early diagnosis and screening strategies. This includes disease prevention services as part of primary healthcare services and the implementation of population level policies to address social, environmental and behavioural risk factors.
Amendment 267 #
Proposal for a regulation Recital 17 b (new) (17b) Early detection and screening plays a crucial role in prevention strategies and in timely treatment and health outcomes. Prevention is key in achieving sustainable health systems by ensuring that citizens live disease-free longer and by reducing the pressure of preventable diseases, especially of non- communicable diseases, on health systems. In order to enhance the health status, well-being, and quality of life of Union citizens, primary care healthcare professionals, including community pharmacists, local authorities and citizens should be involved in raising public health awareness, participating in disease prevention and control. The Programme should support Union actions and support Member States in developing and implementing prevention, early diagnosis and screening strategies. This includes disease prevention services as part of primary healthcare services.
Amendment 268 #
Proposal for a regulation Recital 17 b (new) (17b) The role of primary prevention and health promotion is key to address long term, common European challenges such as non-communicable and communicable diseases, ageing and cross- border health threats such as future pandemics or health crises, and antimicrobial resistance. The Union can bring additional added-value to offer an overall public health strategy based on identified best practices and the European dimension of identified health challenges in the area of access to healthcare, health prevention and promotion in order to reduce health inequalities and health differences in Europe.
Amendment 269 #
Proposal for a regulation Recital 17 b (new) (17b) Sexually transmitted diseases represent a growing health burden, with added risks of cancer and multi- resistance.
Amendment 270 #
Proposal for a regulation Recital 17 c (new) (17c) To achieve Universal Health Coverage as highlighted in the Political Declaration on UHC adopted by the United Nations in September 2019, the EU and its Member States will strive to achieve all targets of SDG 3. In addition to SDG 3.4, it will be essential to achieve SDG3.7 on sexual and reproductive health and rights, as this is a crucial component of UHC. This Programme should therefore contribute to the universal access to and full respect of sexual and reproductive health and rights at the Union and international level.
Amendment 271 #
Proposal for a regulation Recital 18 (18) The Programme therefore should
Amendment 272 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing
Amendment 273 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing
Amendment 274 #
Proposal for a regulation Recital 18 Amendment 275 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the
Amendment 276 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage, unhealthy dietary habits
Amendment 277 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage, obesity, unhealthy dietary habits and physical inactivity, and exposure to environmental pollution, and foster supportive environments for healthy lifestyles in order to complement Member States action in these areas. The Programme should also therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy
Amendment 278 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and
Amendment 279 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage, unhealthy dietary habits and physical inactivity, and exposure to environmental pollution in light of the zero-pollution ambition for a toxic-free environment, and foster supportive environments for healthy lifestyles in order to complement Member States action in these areas. The Programme should also therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.
Amendment 280 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage, unhealthy dietary habits and physical inactivity, and exposure to environmental pollution, and foster supportive environments for healthy lifestyles in order to complement Member States action in these areas.
Amendment 281 #
Proposal for a regulation Recital 18 (18)
Amendment 282 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage,
Amendment 283 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage, unhealthy dietary habits and physical inactivity, and exposure to environmental pollution, and foster supportive environments for healthy lifestyles in order to complement Member States action in these areas.
Amendment 284 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage, obesity, unhealthy dietary habits and physical inactivity, and exposure to environmental pollution, and foster supportive environments for healthy lifestyles in order to complement Member States action in these areas. The Programme should also therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.
Amendment 285 #
Proposal for a regulation Recital 18 (18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing
Amendment 286 #
Proposal for a regulation Recital 18 a (new) Amendment 287 #
Proposal for a regulation Recital 18 a (new) (18a) A holistic long-term health care approach is necessary in view of the growing prevalence of chronic diseases among an ageing EU population. As many conditions that were once fatal, such as HIV, increasingly become chronic and manageable conditions thanks to innovative treatments, healthcare systems need to adapt and provide a comprehensive model of care that takes into account the specific needs of people affected by chronic diseases, thereby improving their health-related quality of life. The Programme should support the development of integrated systems of care that allow for multidisciplinary, cross-disease cooperation between health practitioners in order to ensure that people living with chronic diseases receive adequate support, including in the management of co- morbidities and other health-related issues, such as mental health conditions.
Amendment 288 #
Proposal for a regulation Recital 18 a (new) (18a) Given that health needs differ during a person's lifetime, the Programme should also support Member States to create and implement health programmes that are aligned with the needs of population, and should work to achieve a minimum standard in health programmes that tackle specific populations, such as children's health, maternal health and ageing-related health, as programmes that are horizontal to the lifetime as mental health and reproductive and sexual health.
Amendment 289 #
Proposal for a regulation Recital 18 a (new) (18a) Today, there is a lack of awareness about chronic diseases, such as migraines, despite their psychological and socioeconomic impact; it is important to ensure that neurological disorders, including migraines, are given proper consideration in European policies. The EU and the Member States should include migraines and other chronic diseases in their health priorities.
Amendment 290 #
Proposal for a regulation Recital 18 a (new) (18a) The Programme should continue supporting actions in the area of reducing and preventing alcohol related harm in the perspective of a revised EU alcohol strategy. Protecting children from alcohol commercial communication as well as product placement and sponsorship of alcohol brands, especially in the online environment, should be one of the Programme’s priorities.
Amendment 291 #
Proposal for a regulation Recital 18 a (new) (18a) The Programme should aim to reduce health inequalities including unequal access to treatment and medicines across Member States;
Amendment 292 #
Proposal for a regulation Recital 18 b (new) (18b) The burden of chronic diseases is still significant in the Union. Chronic diseases develop slowly, are long-lasting and often incurable. Chronic diseases are, in many cases, associated with more than one comorbidity, which makes them even more difficult to treat and manage. They have caused great human suffering and placed an enormous burden on health systems, as well. However, many chronic diseases, such as cardiovascular diseases, cancer and type 2 diabetes, could be prevented through access to prevention services, affordability of healthy nutrition and healthy lifestyle, while other illnesses, for instance neurological diseases, can be managed to slow from the onset, if detected early, or helping patients feel their best and remain active for longer. The Union and the Member States can therefore greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, including prevention and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines in the area of both communicable and non- communicable diseases, such as cardiovascular diseases, neurodegenerative diseases, cancer, respiratory diseases and diabetes.
Amendment 293 #
Proposal for a regulation Recital 18 b (new) (18b) The burden of chronic diseases is still significant in the Union. Chronic diseases develop slowly, are long-lasting and often incurable. Chronic diseases are, in many cases, associated with more than one comorbidity, which makes them even more difficult to treat and manage. They have caused great human suffering and placed an enormous burden on health systems, as well. However, many chronic diseases, such as cardiovascular diseases, cancer and type 2 diabetes, could be prevented through access to prevention services, affordability of healthy nutrition and healthy lifestyle, while other illnesses, for instance neurological diseases, can be managed to slow their onset if detected early, or helping patients feel their best and remain active for longer. The Union and Member States can therefore greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, including prevention, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines in the area of both communicable and non- communicable diseases, such as cardiovascular diseases, neurodegenerative diseases, cancer, respiratory diseases and diabetes.
Amendment 294 #
Proposal for a regulation Recital 18 b (new) (18b) Vaccination prevents an estimated 2,5 million deaths each year worldwide and reduces disease-specific treatment costs. The introduction of large-scale protective vaccinations in Europe has significantly contributed to the eradication or decline of many infectious diseases. Nevertheless, the worrying phenomenon of vaccine hesitancy and the disinformation on vaccination should be addressed by the Programme to reassure European citizens.
Amendment 295 #
Proposal for a regulation Recital 18 c (new) (18c) The International Agency for Research on Cancer (IARC) considered classified diesel engine exhaust as carcinogenic to humans. The Programme should make sure that the health impacts and costs of air pollution are integrated into the Union action against cancer, while ensuring full coherence with the European zero emission strategy.
Amendment 296 #
Proposal for a regulation Recital 19 (19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. Cancer is caused by many factors in multiple stages and therefore requires a new prevention paradigm that addresses individual health determinants (genetic, lifestyle) and wider (populations) determinants related to occupational, environmental and social exposure factors; It is also one of non- communicable diseases that share common risk factors with others and the prevention and control of which would benefit the majority of citizens. Poor nutrition, physical inactivity, obesity, tobacco and alcohol are risk factors common to other chronic diseases, such as cardiovascular diseases, type 2 diabetes, and respiratory diseases, and therefore cancer prevention programmes should be conducted within the context of an integrated chronic disease prevention programme. In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover
Amendment 297 #
Proposal for a regulation Recital 19 (19) Ca
Amendment 298 #
Proposal for a regulation Recital 19 (19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. It is also one of non-communicable diseases that share common risk factors and the prevention and control of which would benefit the majority of citizens. Currently no broadly accepted tools such as a “Cancer Dashboard” exist which can serve to measure progress (e.g. EU Cancer Targets) and address inequalities (e.g. in Central and South-Eastern Europe versus the rest of Europe). In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover the entire cycle of the disease starting from prevention and early diagnosis to treatment and quality of life of patients and survivors. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer, in particular by initiatives which support the mid- and long-term goals of the Plan. The actions on cancer should equally address its common shared risk factors and synergies with other major non-communicable diseases such as neurological disorders, as well as reflect upon devising a template for other major disease areas based on the ‘Europe’s Beating Cancer Plan’.
Amendment 299 #
Proposal for a regulation Recital 19 (19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. It is also one of non-communicable diseases that share common risk factors and the prevention and control of which would benefit the majority of citizens. In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover the entire cycle of the disease starting from prevention and early diagnosis to treatment and quality of life of patients and survivors. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer. The actions on cancer should also address its common risk factors and synergies with other major non-communicable diseases, such as neurological diseases, and consider devising a template for other major disease areas based on the ‘Europe’s Beating Cancer Plan’.
Amendment 300 #
Proposal for a regulation Recital 19 (19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. It is also one of several non-communicable diseases that share common risk factors. Addressing the prevention of cancer along with other NCDs in a coordinated fashion and the prevention and control of which would benefit the majority of citizens. In 2020 the
Amendment 301 #
Proposal for a regulation Recital 19 (19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. It is also one of non-communicable diseases that share common risk factors and the prevention and control of which would benefit the majority of citizens. In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover the entire cycle of the disease starting from prevention and early diagnosis to treatment and quality of life of patients and survivors. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer. The actions on cancer should equally address its common shared risk factors and synergies with other major non-communicable diseases such as neurological disorders, as well as reflect upon devising a template for other major disease areas based on the ‘Europe’s Beating Cancer Plan’.
Amendment 302 #
Proposal for a regulation Recital 19 (19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. It is also one of non-communicable diseases that share common risk factors and the prevention and control of which would benefit the majority of citizens. In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover the entire cycle of the disease starting from prevention and early diagnosis to treatment and quality of life of patients and survivors. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer. The actions on cancer should also address its common, shared risk factors and synergies with other major non- communicable diseases, such as neurological disorders, and consider devising a template for other major disease areas.
Amendment 303 #
Proposal for a regulation Recital 19 (19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. It is also one of non-communicable diseases that share common risk factors and the prevention and control of which would benefit the majority of citizens. In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover the entire cycle of the disease starting from prevention and early diagnosis to treatment and quality of life of patients and survivors, as well as better palliative care and pain management. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer. The EU is in a position to take the lead in providing humanitarian support to terminally ill patients by developing and implementing palliative care measures.
Amendment 304 #
Proposal for a regulation Recital 19 (19) Cancer
Amendment 305 #
Proposal for a regulation Recital 19 a (new) (19a) It is well recognised that cancer is often diagnosed late, which means that fewer treatment options are available for people affected by an advanced stage of the disease. If more patients were diagnosed earlier, it could lead to much more effective treatment outcomes, better quality of life, as well as improved overall survival rates. An earlier diagnosis means also a reduction in the healthcare burden. Compared to early diagnosis, cancer screening is a distinct and more complex public health strategy that mandates additional resources, infrastructure and coordination. When planned effectively, appropriately financed and implemented, screening can reduce deaths from cancer and, in the case of some cancer types, can also reduce the risk of developing cancer. The Programme should therefore contribute to the investment in early diagnosis and screening, and to promotion and awareness raising in relation to the benefits of such early diagnosis and screening. The EU should have extensive cancer screening recommendations and guidelines for all major cancers to be implemented in all Member States.
Amendment 306 #
Proposal for a regulation Recital 19 a (new) (19a) It is well recognised that cancer is often diagnosed late, which means that fewer treatment options are available for people affected by an advanced stage of the disease. If more patients were diagnosed earlier, it could lead to much more effective treatment outcomes, better quality of life, as well as improved overall survival rates. An earlier diagnosis means also a reduction in the healthcare burden. Compared to early diagnosis, cancer screening is a distinct and more complex public health strategy that mandates additional resources, infrastructure and coordination. When evidence-based, planned effectively, appropriately financed and implemented, screening can reduce deaths from cancer and, in the case of some cancer types, can also reduce the risk of developing cancer. The Programme should therefore contribute to the investment in early diagnosis and evidence-based screening, and to promotion and awareness raising in relation to the benefits and adverse effects of such early diagnosis and screening.
Amendment 307 #
Proposal for a regulation Recital 19 a (new) (19a) Under Article 153 TFEU, the Union is to support and complement the activities of Member States concerning improvement of the working environment, and protection of workers' health, safety and working conditions. Considering the large amount of time that the workers spend in their workplaces and the possible risk they could have, such as exposure to health hazard substances and carcinogens and to repeated movements, leading to a high burden of incapacity and number of work days lost, which in turn has consequences for the individual, family and society. The Programme should also reflect the importance of occupational health and its impact on health workers and societies. The Commission should work with Member States to create new legislation to improve workers health conditions, improve their working conditions, the balance between work and life, promote wellbeing and better mental health, prevent early-retirement due to ill health and poor health management.
Amendment 308 #
Proposal for a regulation Recital 19 a (new) (19a) While the Union currently has a strong focus on cancer as expressed in ‘Europe’s Beating Cancer Plan’ and Horizon Europe’s Mission on Cancer, the Programme must ensure that patients living with other major chronic diseases such as cardiovascular disease, chronic respiratory disease, diabetes and mental health conditions benefit from it in a proportionate manner. In Europe, chronic diseases are responsible for 77% of the total disease burden (measured in DALYs = disability-adjusted life years). Of these, cardiovascular disease makes up 23%, neuropsychiatric conditions 20% and cancer 11%. The Programme should ensure that the actions it supports will benefit equitably all chronic disease patients. In that context, it should be acknowledged that the Programme goes beyond the current EU mandate, running well into the next EU mandate as it comes to an end in 2027.
Amendment 309 #
Proposal for a regulation Recital 19 a (new) (19a) A recent study by authors from IARC published in the February 2020 edition of the Lancet Global Health Journal, highlights a crucial need for resources directed towards cancer prevention programmes that target infection, namely helicobacter pylori, human papillomavirus, Hepatitis B virus and Hepatitis C virus, particularly in high-risk populations. Such interventions can markedly reduce the increasing cancer burden and associated mortality. The Programme should just ensure that will promote measures to tackle infectious diseases, helping their prevention, through vaccination, if available, awareness raising, early diagnosis/screening, and linkage to care, with a view to promoting the prevention of cancer as a key European Commission goal.
Amendment 310 #
Proposal for a regulation Recital 19 a (new) (19a) There is plenty of scientific evidence that shows that health prevention and promotion policies (public health policies) are central to guaranteeing the right to health of citizens, and those are also the most efficient in terms of cost effectiveness. However, even today most of the budgets of the health systems of the majority of Member States are given very little space to policies for the prevention and promotion of health. The COVID-19 pandemic has firmly confirmed the importance of public health policies for our societies. For this reason, it is necessary that the projects of the EU4Health programme accompany Member States to reformulate the budgets of their health systems in order to fulfil greater financial strength to these policies.
Amendment 311 #
Proposal for a regulation Recital 19 a (new) (19a) The programme could participate to the establishment of a European Cancer Institute (ECI) which would provide a platform for the implementation of the standards of practices through European Reference Cancer Networks, the collection of clinical data among centres from all participating countries across Europe and beyond and the prioritisation of academic and clinical research programmes of excellence. The programme could support the development of national cancer registries in all Member States which are essential to provide comparable data on cancer.
Amendment 312 #
Proposal for a regulation Recital 19 a (new) (19a) Heart attacks and strokes often occur in people previously undiagnosed with cardiovascular diseases. Many of these are due to undetected genetic conditions, such as familial hypercholesterolaemia, arrhythmias, congenital heart disease and cardiomyopathies, and conditions such as hypertension. The Programme should support the development of policies and interventions to identify and manage individuals at high risk of developing cardiovascular disease in order to prevent the onset of the disease and reduce mortality.
Amendment 313 #
Proposal for a regulation Recital 19 a (new) (19a) Late diagnosis of cancer and Structural Heart Diseases reduces treatment options available for people affected by an advanced stage of the disease. Early diagnosis is crucial for effective treatment outcomes, better quality of life and reduction of the healthcare burden. The Programme should therefore contribute to the investment in early diagnosis and screening, and to the promotion and awareness raising in relation to the benefits of such early diagnosis and screening for cancer and Structural Heart Diseases.
Amendment 314 #
Proposal for a regulation Recital 19 a (new) (19a) Obesity is the fourth largest direct cause of premature mortality in the EU. In this context, obesity acts as a gateway chronic disease to the onset of 80% of Type 2 Diabetes cases and 20%of cancers. Obesity has been recognised as one of the high risk pre-existing chronic diseases in the EU and must be subject to evidence- based policymaking, which should be aligned with international standards and national implementation trends.
Amendment 315 #
Proposal for a regulation Recital 19 a (new) (19a) The Programme should ensure that patients living with and suffering from any chronic disease such as cardiovascular disease, cancer, obesity, chronic respiratory disease, neurologic disorder, diabetes or mental health disorder benefit from it in a proportionate manner.
Amendment 316 #
Proposal for a regulation Recital 19 b (new) (19b) The IARC shows that more than 35,000 children and young people are diagnosed with cancer and over than 6,000 young patients die annually in Europe. Paediatric cancers are a category of age- and biologically specific rare malignancies that cannot be appropriately addressed by extrapolation of adult cancer approaches and require a dedicated effort across the research and care continuum. There is a lack of innovative therapies to treat children with cancer. Even for older off-patent medicines used off-label on children, there are still pronounced access issues including shortages across the Union and budget limitations in some Member States, as well as major differences among countries in pain control accessibility for children undergoing treatment for cancer. Hence, there is an urgent need to appropriately revise the regulatory environment so that the needs of children and adolescents are met. The Programme should therefore provide for actions in this regard, in particular aiming to reinforce Regulation (EC) No 1901/2006 of the European Parliament and of the Council. and support cross-border research collaboration by granting appropriate allocations and to amend Article 10 of the directive 2001/83/EC, in order to include a paragraph to stimulate innovation on the off-patented medicines.
Amendment 317 #
Proposal for a regulation Recital 19 b (new) (19b) The health workforce has a vital role in building resilient health systems and in reaching the highest attainable standard of health. The Programme should therefore underpin the Commission’s work on effective, accessible and resilient healthcare and health systems, and support the development and implementation of a strategy on the health workforce. In synergy with ESF+ and in particular EaSI, the Programme should provide under the Strategy the means for harmonized training and education for the purpose of improving the curricula of health professionals, in particular with regard to health promotion and disease prevention as well as digital skills, in order to obtain a patient-oriented and outcome-based health approach. The Programme should also support, via the Strategy, Member States to address the brain drain and migration of the healthcare workforce from less-developed countries and implement retention policies. Being able to deliver high quality, personalised, targeted and integrated care, and improve health service coverage depends on the availability, accessibility, acceptability, adaptability and quality of the health workforce.
Amendment 318 #
Proposal for a regulation Recital 19 b (new) (19b) Likewise, it is absolutely necessary to remember that these prevention and promotion strategies concern all sectoral policies: fiscal, commercial, economic, educational, housing, cultural, social assistance, etc. "Health in all policies" (HiAP) should be a non-negotiable principle of all public policies. An instrument already used at the national level is the so-called Health Test to assess the health impact of the different sectoral policies. It is necessary to deploy a Health Test methodology of all the programmes managed by the Union.
Amendment 319 #
Proposal for a regulation Recital 19 b (new) (19b) Heart attacks and strokes often occur in people previously undiagnosed with cardiovascular disease. Many of these are due to undetected genetic conditions, such as familial hypercholesterolaemia, arrhythmias, congenital heart disease and cardiomyopathies and conditions, such as hypertension. The Programme should support the development of policies and interventions for reaching out to and managing individuals at high risk of developing cardiovascular disease to prevent the onset of the disease and reduce mortality.
Amendment 320 #
Proposal for a regulation Recital 19 b (new) (19b) While the Union currently has a strong focus on cancer as expressed in ‘Europe’s Beating Cancer Plan’ and Horizon Europe’s Mission on Cancer, the Programme should ensure that patients living with other major chronic diseases such as cardiovascular disease, chronic respiratory disease, diabetes and mental health conditions benefit from it in a proportionate manner.
Amendment 321 #
Proposal for a regulation Recital 19 c (new) (19c) A crucial part of treatment for cardiovascular disease is rehabilitation after an event, including counselling, medical treatment, exercise and psychological support. These programmes help prevent recurrence, optimise quality of life, reintegrate patients into the job market and reduce the burden on health services by reducing hospital readmissions. Although the considerable benefits of cardiac and stroke rehabilitation for patients, as well as the wider society, are well-documented, access to and uptake of quality rehabilitation is patchy in most of the Union’s Member States and is considered an underutilised resource. The Programme should support increased uptake of rehabilitation and secondary prevention.
Amendment 322 #
Proposal for a regulation Recital 19 c (new) (19c) A crucial part of treatment of diseases is rehabilitation, including counselling, medical treatment, exercise and psychological support. These programmes help prevent recurrence, optimise quality of life, reintegrate patients into the job market and reduce the burden on health services by reducing hospital readmissions. Although there are considerable benefits for patients, as well as the wider society, the access to and uptake of quality rehabilitation is patchy in most of the Member States and is considered an underutilised resource. The Programme should support increased uptake of rehabilitation and secondary prevention reducing the burden of diseases.
Amendment 323 #
Proposal for a regulation Recital 19 c (new) (19c) It is well recognised that cancer is often diagnosed late, which means that fewer treatment options are available for people affected by an advanced stage of the disease. The Programme should therefore contribute to the investment in early diagnosis and screening, and to promotion and awareness raising in relation to the benefits of early diagnosis and screening, in line with or going beyond WHO, UN and EU recommendations, and in synergy with Horizon Europe, its Mission on Cancer and the relevant partnerships.
Amendment 324 #
Proposal for a regulation Recital 19 d (new) (19d) Paediatric cancers are a category of age- and biologically-specific rare malignancies that cannot be appropriately addressed by extrapolation of adult cancer approaches and require a dedicated effort across the research and care continuum. The Programme should provide for actions oriented at paediatric cancer, in particular aiming to address the limitations of the Regulation (EC) No 1901/2006 of the European Parliament and of the Council1a in this disease area and support cross-border research collaboration by granting appropriate allocations in synergy with Horizon Europe, its Mission on Cancer and the relevant partnerships. __________________ 1aRegulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance) (OJ L 378, 27.12.2006, p. 1).
Amendment 325 #
Proposal for a regulation Recital 20 (20) The Programme will work in synergy and complementarity with other EU policies, programmes and funds such as actions implemented under the Digital Europe Programme, Horizon Europe, rescEU reserve under the Union Civil Protection Mechanism, Emergency Support Instrument, European Social Fund+ (ESF+, including as regards synergies on better protecting the health and safety of millions of workers in the EU), including the Employment and Social Innovation Strand (EaSI), the InvestEU fund, Single Market Programme, European Regional Development Fund (ERDF), Recovery and Resilience Facility including the Reform Delivery Tool, Erasmus, European Solidarity Corps, Support to mitigate Unemployment Risks in an Emergency (SURE), and EU external action instruments, such as the Neighbourhood, Development and International Cooperation Instrument and the Instrument for Pre-accession Assistance III. Where appropriate, common rules will be established in view of ensuring consistency and complementarity between funds, avoiding any overlap or duplication of financing, while making sure that specificities of these policies are respected, and in view of aligning with the strategic requirements of these policies, programmes and funds, such as the enabling conditions under ERDF and ESF+.
Amendment 326 #
Proposal for a regulation Recital 20 (20) The Programme will work in synergy and complementarity with other EU policies, programmes and funds such as actions implemented under the Digital Europe Programme, Horizon Europe, rescEU reserve under the Union Civil Protection Mechanism, Emergency Support Instrument, European Social Fund+ (ESF+, including as regards synergies on better protecting the health and safety of millions of workers in the EU), including the Employment and Social Innovation Strand (EaSI), the InvestEU fund, Single Market Programme, European Regional Development Fund (ERDF) including Interreg, Recovery and Resilience Facility including the Reform Delivery Tool, Erasmus, European Solidarity Corps, Support to mitigate Unemployment Risks in an Emergency (SURE), and EU external action instruments, such as the Neighbourhood, Development and International Cooperation Instrument and the Instrument for Pre-accession Assistance III. Where appropriate, common rules will be established in view of ensuring consistency and complementarity between funds, while making sure that specificities of these policies are respected, and in view of aligning with the strategic requirements of these policies, programmes and funds, such as the enabling conditions under ERDF and ESF+.
Amendment 327 #
Proposal for a regulation Recital 20 a (new) (20a) The health workforce has a vital role in building resilient health systems and in reaching the highest attainable standard of health. The Programme should therefore underpin the Commission’s work on effective, accessible and resilient healthcare and health systems, and support the development and implementation of a strategy on the health workforce. In synergy with European Social Fund Plus (ESF+), and in particular Employment and Social Innovation (EaSI), the Programme should provide under the Strategy the means for harmonized training and education for the purpose of improving the curricula of health professionals and their digital skills, in order to obtain a patient-oriented and outcome-based health approach. The Programme should also support, via the Strategy, Member States to address the brain drain and migration of the healthcare workforce from Member States of the eastern flank of the European Union and implement retention policies. Being able to deliver high quality, standardised, targeted and integrated care, and improve health service coverage depends on the availability, accessibility, acceptability, adaptability and quality of the health workforce.
Amendment 328 #
Proposal for a regulation Recital 20 a (new) (20a) The programme should encompass a “Health in all policies” and “Health in all fundings” approaches in its implementation and evaluation. In the programme’s framework, the Commission should proceed to a systematic health impact assessment, built on cross-sectorial indicators, of all EU policies and fundings in order to evaluate their impact on improving health and well-being of our citizens.
Amendment 329 #
Proposal for a regulation Recital 20 a (new) (20a) The programme should support vulnerable population groups that have more difficulty in accessing healthcare, due to their socio-economic or geographic characteristics. Synergies between the Programme and ESF+ and ERDF are crucial, and the Commission should take into account the particularity of remotes areas and more concretely, the outermost regions based on Article 349 TFEU.
Amendment 330 #
Proposal for a regulation Recital 20 b (new) (20b) The programme should guarantee a strong involvement of the civil society (in particular patients' associations) and academics (in particular healthcare professionals' societies) to ensure a balanced representation and participation in achieving public health goals. European health organizations should contribute to the implementation and the evaluation of the programme.
Amendment 331 #
Proposal for a regulation Recital 20 c (new) (20c) The evaluations of the last and current programmes should be taken into consideration in the framework of the Conference on the Future of Europe, which could come forward with clear proposals to strengthen the European Health Policy.
Amendment 332 #
Proposal for a regulation Recital 21 (21) In accordance with Article 114 TFEU, a high level of health protection should be ensured in the legislation adopted by the Union for the establishment and the functioning of the internal market. On the basis of Article 114 TFEU and point (c) of Article 168(4) TFEU, a considerable body of Union acquis was developed which guarantees the high standards of quality and safety for medicinal products and medical devices. Given the rising healthcare demand, Member States’ healthcare systems face challenges in the availability, accessibility and affordability of medicines and medical devices. To ensure a better public health protection as well as the safety and empowerment of patients in the Union, it is essential that patients and health systems have access to high quality healthcare products and can fully benefit from them. Such access could be promoted through improved coordination between Member States and through the maintenance of an open and well–functioning internal market at all times.
Amendment 333 #
Proposal for a regulation Recital 21 (21) In accordance with Article 114 TFEU, a high level of health protection should be ensured in the legislation adopted by the Union for the establishment and the functioning of the internal market. On the basis of Article 114 TFEU and point (c) of Article 168(4) TFEU, a
Amendment 334 #
Proposal for a regulation Recital 21 (21) In accordance with Article 114 TFEU, a high level of health protection should be ensured in the legislation adopted by the Union for the establishment and the functioning of the internal market. On the basis of Article 114 TFEU and point (c) of Article 168(4) TFEU, a considerable body of Union acquis was developed which guarantees the high standards of quality and safety for medicinal products and medical devices. Given the rising healthcare demand, Member States’ healthcare systems face challenges in the availability and affordability of medicines and medical devices. To ensure a better public health protection as well as the safety and empowerment of patients in the Union, it is
Amendment 335 #
Proposal for a regulation Recital 21 (21) In accordance with Article 114 TFEU, a high level of health protection should be ensured in the legislation adopted by the Union for the establishment and the functioning of the internal market. On the basis of Article 114 TFEU and point (c) of Article 168(4) TFEU, a considerable body of Union acquis was developed which guarantees the high standards of quality and safety for medicinal products and medical devices. Given the rising healthcare demand, Member States’ healthcare systems face challenges in the availability and affordability of medicines and medical devices. To ensure a better public health protection as well as the safety and empowerment of patients in the Union, it is essential that patients and health systems have access to affordable high quality healthcare products and can fully benefit from them.
Amendment 336 #
Proposal for a regulation Recital 21 a (new) (21a) The programme should contribute to the strengthening of the European Medicines Market to speed up equitable access to medicines, make care more affordable, maximize savings in national health budgets and avoid obstacles for generic and biosimilar use.
Amendment 337 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor and mitigate shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines and treatment, promote incentives to
Amendment 338 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet
Amendment 339 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor shortages of medicines, medical devices and other healthcare products and to ensure greater
Amendment 340 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor, prevent and manage shortages of
Amendment 341 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor shortages of medicines, medical devices and other
Amendment 342 #
Proposal for a regulation Recital 22 (22) The Programme should
Amendment 343 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digit
Amendment 344 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor and respond to shortages of medicines, medical devices, vaccines and diagnostic tools and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digit
Amendment 345 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries, in particular actions, where necessary in synergy with other programmes, to encourage local production of medicinal plants in the Member States, and to encourage and support production of active ingredients and generics within the European Union. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digit
Amendment 346 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor, prevent and manage shortages of medicines, medical devices and other healthcare products and to ensure greater
Amendment 347 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to
Amendment 348 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to
Amendment 349 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to
Amendment 350 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to develop a pan-European monitoring, reporting and notification system to monitor shortages of medicines, medical devices and other healthcare products to strengthen the Single Market, and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective
Amendment 351 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to
Amendment 352 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor shortages of medicines, medical devices and other healthcare products and to ensure greater availability, accessibility and affordability of those products while limiting the dependency of their supply chains on a small number of manufacturers and evaluating the Union's dependency on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digit
Amendment 353 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to
Amendment 354 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor and prevent shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on
Amendment 355 #
Proposal for a regulation Recital 22 (22) The Programme should therefore support actions to monitor and to prevent shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digit
Amendment 356 #
Proposal for a regulation Recital 22 a (new) (22a) Resolution WHA 67.18 of the World Health Assembly urges parties to 1) adapt, adopt and implement, where appropriate, the WHO Traditional Medicine Strategy 2014 – 2023, as a basis for national traditional and complementary medicine programmes or work plans; and to 2) develop and implement working plans to integrate traditional and complementary medicine into health services, particularly primary health care services. The WHO Traditional Medicine Strategy 2014 – 2023 aims to support Member States in developing policies and implementing action plans to promote health with the support of traditional, complementary and integrative medicine.
Amendment 357 #
Proposal for a regulation Recital 22 a (new) (22a) Support actions to ensure the implementation of cross-cutting EU policy initiatives aimed at building a sustainable Europe with a high level of human health protection, such as the European Green Deal and its component strategies.
Amendment 358 #
Proposal for a regulation Recital 22 a (new) (22a) In its Pharmaceutical Strategy, the Commission should introduce the revision of the orphan and paediatric legislation and of the Directive 2001/83/EC establishing a Community code relating to medicinal products for human use.
Amendment 359 #
Proposal for a regulation Recital 22 b (new) (22b) To expand access to health technologies, the Programme should support actions that contribute to the implementation of the 2019 Resolution by the World Health Assembly on improving the transparency of markets for medicines, vaccines and other health products.
Amendment 360 #
Proposal for a regulation Recital 22 b (new) (22b) To ensure effective controls and full transparency of the procedures used to determine the prices of medicines, the Commission should propose a revision of Directive 89/105/EEC on the transparency of measures regulating the price of medicinal products.
Amendment 361 #
Proposal for a regulation Recital 22 c (new) (22c) To reduce its dependence on third countries for certain biological and medicinal products such as blood and plasma derived medicinal products, the Union should increase its capacity to collect and stockpile blood and plasma. To avoid the risk of shortages on those products, the Union should rapidly revise the Blood, Tissues and Cells legislations, Directive 2002/98/EC and Directive 2004/23/EC.
Amendment 362 #
Proposal for a regulation Recital 23 (23) As the optimal use of medicines and antimicrobials in particular yields benefits for individuals and health systems, the Programme should promote their prudent and efficient use. In line with the European One Health Action Plan against Antimicrobial Resistance14 , adopted in June 2017 following the request from Member States, and given that infections caused by antibiotic-resistant bacteria were responsible for 33,110 deaths in the European Union and European Economic Area in 2015, according to data from the European Center for Disease Control, as well as the experience with the bacterial secondary infections related to COVID 19, it is essential that the Programme supports actions aimed at the prudent use of antimicrobials in humans, animals and crops, in the framework of an integrated policy on patient safety and prevention of medical errors. Notes moreover that the spread of Antimicrobial Resistance will require a greater emphasis in the Programme on preventing infections due to Gram-negative bacteria because there are relatively few existing treatment options for them and a limited number of new antibiotics in development. __________________ 14Communication from the Commission to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017.
Amendment 363 #
Proposal for a regulation Recital 23 (23) As the optimal use of medicines and antimicrobials in particular yields benefits for individuals and health systems, the Programme should promote their prudent and efficient use. In line with the European One Health Action Plan against Antimicrobial Resistance14
Amendment 364 #
Proposal for a regulation Recital 23 (23) As the optimal use of medicines and antimicrobials in particular yields benefits for individuals and health systems, the Programme should promote their prudent and efficient use. In line with the European One Health Action Plan against Antimicrobial Resistance14 , adopted in June 2017 following the request from Member States, and given the experience with the bacterial secondary infections related to COVID 19, it is essential that the Programme supports actions aimed at the prudent use of antimicrobials in humans, animals and crops, in the framework of an integrated policy on patient safety and prevention of medical errors. Regulation (EU) 2019/6 on veterinary medicinal products should be reviewed in this regard to use antibiotic medicinal products and other medication only for treatment of disease prescribed by a veterinary for a limited period of time and not to be used for prophylaxis. __________________ 14Communication from the Commission to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017.
Amendment 365 #
Proposal for a regulation Recital 23 (23) As the optimal use of medicines and antimicrobials in particular yields benefits for individuals and health systems, the Programme should promote their prudent and efficient use. In line with the European One Health Action Plan against Antimicrobial Resistance14 , adopted in June 2017 following the request from Member States, and given the experience with the bacterial secondary infections related to COVID 19, it is essential that the Programme supports actions aimed at the prudent use of antimicrobials in humans, animals and crops, in the framework of an integrated policy on patient safety and prevention of medical errors. TheEU4health programme funding should be based on actions that are traceable, setting Union-wide reduction targets for antibiotics and medicine use, and support the research and development of new antibiotics __________________
Amendment 366 #
Proposal for a regulation Recital 23 (23) As the optimal use of medicines and antimicrobials in particular yields benefits for individuals and health systems, the Programme should promote their prudent and efficient use. In line with the European One Health Action Plan against Antimicrobial Resistance14
Amendment 367 #
Proposal for a regulation Recital 23 a (new) (23a) Health associated infections (‘HAI’) are infections that patients get while receiving healthcare for another condition. The ECDC has estimated that, on average, healthcare associated infections occur in one hospitalised patient in 20, that is to say 4,1 million patients a year in the Union, and that 37 000 deaths are caused every year as a result of such infections. Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. HAI can happen in any healthcare facility, including hospitals, ambulatory surgical centres, end-stage renal disease facilities, and long-term care facilities It is therefore important that the Commission, under the Programme, develops guidelines for preventing HAI, and that the Programme supports investment in modernizing health systems to overcome and reduce HAI and supports interventions to improve patient safety, including the implementation of Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections. European-level collaboration and coordination on patient safety should be enhanced through the creation of a European Network on Patient Safety, supported through the Health Programme and with direct involvement of patients’ organisations.
Amendment 368 #
Proposal for a regulation Recital 23 a (new) (23a) HAI are infections that patients get while receiving healthcare for another condition. The ECDC has estimated that, on average, health care associated infections occur in one hospitalised patient in 20, that is to say 4,1million patients a year in the Union, and that 37 000 deaths are caused every year as a result of such infections. Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. HAI can happen in any healthcare facility, including hospitals, ambulatory surgical centres, end-stage renal disease facilities, and long-term care facilities It is therefore important that the Commission, under the Programme, develops guidelines for preventing HAI, and that the Programme supports investment in modernizing health systems to overcome and reduce HAI and supports interventions to improve patient safety, including the implementation of Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections. European-level collaboration and coordination on patient safety should be enhanced through the creation of a European Network on Patient Safety, supported through the Health Programme and with direct involvement of patients’ organisations.
Amendment 369 #
Proposal for a regulation Recital 23 a (new) (23a) HAI are infections that patients get while receiving healthcare for another condition or infections suffered by inhabitants of long-term residences. The ECDC has estimated that, on average, healthcare associated infections occur in one hospitalised patient in 20, that is to say 4,1 million patients a year in the Union, and that 37 000 deaths are caused every year as a result of such infections. Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. HAI can happen in any healthcare facility, including hospitals, ambulatory surgical centres, end-stage renal disease facilities, and long-term care facilities It is therefore important that the Commission, under the Programme, develops guidelines for preventing HAI, and that the Programme supports investment in modernizing health systems to overcome and reduce HAI and supports interventions to improve patient safety, including the implementation of the Council's Recommendation of 9 June 2009 on patient safety, including the prevention and control of HAI 1a.
Amendment 370 #
Proposal for a regulation Recital 23 a (new) (23a) Effective international collaboration is key to controlling HAIs and Antimicrobial Resistance and the EU has an important role in supporting Member States in this area, for example through research programmes, the surveillance systems operated by the ECDC and the development of EU wide point prevalence survey methodology.
Amendment 371 #
Proposal for a regulation Recital 23 a (new) (23a) According to WHO, 12.6 million people died as a result of living or working in an unhealthy environment in2012 – nearly 1 in 4 of total global deaths. Environmental pollution factors, such as air, water and soil pollution, chemical exposures, climate change, and ultraviolet radiation, contribute to more than 100 diseases and injuries.
Amendment 372 #
Proposal for a regulation Recital 23 b (new) (23b) The Programme should promote and guarantee via its actions the environmental health of European citizens in the framework of the European Green Deal. The Union should adopt the WHO definition which describes environmental health as the inclusion of “ aspects of human health, such as the quality of life, which are determined by the physical, chemical, biological, social, psychosocial and aesthetic factors of our environment. It also concerns the policy and practices for the prevention, management and control of environmental factors likely to affect the health of present and future generations”.
Amendment 373 #
Proposal for a regulation Recital 24 (24) Since environmental pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem that can impact on public health, the Programme should foster measures to strengthen the assessment and appropriate management of environmental risks associated with the production, use and disposal of medicinal products, in line with the European Union Strategic Approach to Pharmaceuticals in the Environment15
Amendment 374 #
Proposal for a regulation Recital 24 (24) Since
Amendment 375 #
Proposal for a regulation Recital 25 (25) The Union health legislation has an immediate impact on public health, the lives of citizens, the efficiency and resilience of the health systems and the good functioning of the internal market. The regulatory framework for the recognition of professional qualifications, medical products and technologies (medicinal products, medical devices and substances of human origin), as well as for tobacco legislation, patients’ rights in cross-border healthcare and serious cross- border threats to health is essential to health protection in the Union. The Programme therefore should support the development, implementation and enforcement of Union health legislation and provide high quality, unbiased, comparable and reliable data to underpin policymaking and monitoring. Union health legislation needs to be based on current scientific evidence-based data, that should be collected locally across Europe, through a well-defined homogeneous methodology. The legislation and its implementation and consequences should be evaluated and reported, resulting in a cycle of quality improvement of health in the Union.
Amendment 376 #
Proposal for a regulation Recital 25 (25) The Union health legislation has an immediate impact on public health, the lives of citizens, the efficiency and resilience of the health systems and the good functioning of the internal market. The regulatory framework for medical products and technologies (medicinal products, medical devices and substances of human origin), as well as for tobacco legislation, patients’ rights in cross-border healthcare and serious cross-border threats to health is essential to health protection in the Union. The Programme therefore should support the development, implementation and enforcement of Union health legislation and, working in conjunction with key partners such as the EMA and the ECDC, provide high quality, comparable and reliable data to underpin policymaking and monitoring.
Amendment 377 #
Proposal for a regulation Recital 25 (25) The Union health legislation has an immediate impact on public health, the lives of citizens, the efficiency and resilience of the health systems and the good functioning of the internal market. The regulatory framework for medical products and technologies (medicinal products, medical devices and substances
Amendment 378 #
Proposal for a regulation Recital 25 (25) The Union health legislation has an immediate impact on public health, the lives of citizens, the efficiency and resilience of the health systems and the good functioning of the internal market. The regulatory framework for medical products and technologies (medicinal products, medical devices and substances of human origin), as well as for tobacco legislation, patients’ rights in cross-border healthcare and serious cross-border threats to health is essential to health protection in the Union. The Programme therefore should support the development, implementation and enforcement of Union
Amendment 379 #
Proposal for a regulation Recital 25 (25) The Union health legislation has an immediate impact on public health and safety, the lives of citizens, the efficiency and resilience of the health systems and the good functioning of the internal market. The regulatory framework for medical products and technologies (medicinal products, medical devices and substances of human origin), as well as for tobacco legislation, patients’ rights in cross-border healthcare and serious cross-border threats to health is essential to health protection in the Union. The Programme therefore should support the development, implementation
Amendment 380 #
Proposal for a regulation Recital 25 (25) The Union health legislation has an immediate impact on public health, the lives of citizens, the efficiency and resilience of the health systems and the good functioning of the internal market. The regulatory framework for medical products and technologies (medicinal products, medical devices and substances of human origin), as well as for tobacco legislation, patients’ rights in cross-border healthcare and serious cross-border threats to health is essential to health protection in the Union. The Programme therefore should support the development, implementation and enforcement of Union health legislation and provide high quality, unbiased, comparable and reliable data, including real-world healthcare data, to underpin policy making and monitoring.
Amendment 381 #
Proposal for a regulation Recital 25 a (new) Amendment 382 #
Proposal for a regulation Recital 25 a (new) (25a) The Union environmental legislation has an indirect, albeit important impact on public health and the resilience of national health systems. A strong and well-functioning EU environmental regulatory framework is essential to health protection. The Programme therefore should support the development, implementation and enforcement of Union environmental legislation towards a non-toxic environment.
Amendment 383 #
Proposal for a regulation Recital 26 (26) Cross-border cooperation in the provision of healthcare to patients moving between Member States, collaboration on health technology assessments (HTA), and European Reference Networks (ERNs) are examples of areas where integrated work among Member States has shown to have strong added value and great potential to increase the efficiency of health systems and thus health in general. Th
Amendment 384 #
Proposal for a regulation Recital 26 (26) Cross-border cooperation in the provision of healthcare to patients moving between Member States or living in border regions, collaboration on health technology assessments (HTA), and European Reference Networks (ERNs) are examples of areas where integrated work among Member States has shown to have strong added value and great potential to increase the efficiency of health systems and thus health in general. The Programme should therefore support activities to enable such integrated and coordinated work, which also serves to foster the
Amendment 385 #
Proposal for a regulation Recital 26 a (new) (26a) Cross-border cooperation in the provision of healthcare to patients moving between Member States, as provided for under Directive 2011/24/EU, includes European Reference Networks (‘ERN’). This is an example where integrated work among Member States has been shown to have strong added value and great potential to increase the efficiency of health systems and therefore health in general. However, it is still to be fully elaborated in terms of Union legislation, implementation and resources. The Programme should therefore aim at ensuring that such integrated and coordinated work is developed and implemented to its full potential in areas such as ERN. That work would serve to foster the implementation of high-impact practices aimed at distributing, in the most effective way, available resources to the relevant population so as to maximise their impact.
Amendment 386 #
Proposal for a regulation Recital 26 a (new) (26a) Solidarity and unity are principles of the Union and the programme should ensure that the Union has a coherent approach to combating cross-border health-threats. Under Article 168 TFEU, the Programme should support the creation of a European Health Response Mechanism, ready to respond to public health threats, coordinated by the ECDC and led by the Commissioner for Health and the Commissioner for Crisis Management, fully articulated with the other EU health agencies. This Mechanism with its own medical resources under a strengthened Union Civil Protection Mechanism will be prepared with a pandemic emergency plan, in order to have a coordinated response and the capacity to rapidly scale up the response to future health crises, based on standardised information.
Amendment 387 #
Proposal for a regulation Recital 26 a (new) (26a) The mobility of cross-border medical workers should be guaranteed in order to ensure the continuity of healthcare services within the European Union.
Amendment 388 #
Proposal for a regulation Recital 27 (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases
Amendment 389 #
Proposal for a regulation Recital 27 (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases to communicable and non- communicable diseases such as cardiovascular disease, cancer, chronic respiratory disease, diabetes and mental health conditions and other major chronic diseases, which require extensive knowledge sharing due to the complexity of cases and co-morbidities, and their increasing prevalence
Amendment 390 #
Proposal for a regulation Recital 27 (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases to communicable and non- communicable diseases such as cancer, chronic respiratory disease, diabetes and mental health conditions and other major chronic diseases, which require extensive knowledge sharing due to the complexity of cases and co-morbidities, and their increasing prevalence. __________________ 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 391 #
Proposal for a regulation Recital 27 (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases to communicable and non- communicable diseases such as ca
Amendment 392 #
Proposal for a regulation Recital 27 (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases to communicable and non- communicable diseases such as cancer, without impacting the efficiency of the 24 existing ERNs which are working on a range of thematic issues including bone disorders, childhood cancer and immunodeficiency. __________________ 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 393 #
Proposal for a regulation Recital 27 (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases to communicable and non- communicable diseases such as cancer, cardiovascular disease, chronic respiratory disease, mental health conditions and other major chronic diseases. __________________ 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 394 #
Proposal for a regulation Recital 27 (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases to complex communicable and non-
Amendment 395 #
Proposal for a regulation Recital 27 (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers
Amendment 396 #
Proposal for a regulation Recital 27 a (new) (27a) The programme should support the EU-wide mobility of healthcare professionals, during both their education and professional careers through Erasmus + fundings, and of their particular role in improving knowledge and expertise on health threats. The programme should also facilitate the implementation of the Professional Qualifications Directive to ensure better mutual recognition of qualifications of health professionals within the Union.
Amendment 397 #
Proposal for a regulation Recital 27 a (new) (27a) The ERNs face significant challenges to ensure they are financially sustainable and are able to operate effectively within and across national healthcare systems, as highlighted by the European Court of Auditors, in their “Special report no 07/2019: EU actions for cross-border healthcare”.
Amendment 398 #
Proposal for a regulation Recital 27 a (new) (27a) Priority should be given to clinical genomics and disease prediction programmes based on the genetic make- up of individuals (personalised or precision medicine), and the EU should lead this initiative.
Amendment 399 #
Proposal for a regulation Recital 27 b (new) (27b) The programme should facilitate the coordination and pooling of European multicentre clinical trials and promote the research and training actions of future European universities networks.
Amendment 400 #
Proposal for a regulation Recital 27 c (new) (27c) The programme should guarantee the sustainable funding of European research consortia on medicines, vaccines and biological tests designed for specific infectious and transmissible diseases.
Amendment 401 #
Proposal for a regulation Recital 27 d (new) (27d) The Programme should take concrete actions against rare, complex and low-prevalence diseases. Early detection must be facilitated and projects such as “Rare 2030” encouraging with the objective to set up concrete and innovative policies for developing research and improving the lives of patients.
Amendment 402 #
Proposal for a regulation Recital 27 e (new) (27e) The programme should facilitate the revision of the EU-OSHA’s mandate to promote healthy and safe workplaces across the Union and to support the Agency’s activities and analysis on occupational safety and health. The Commission should propose a new EU Strategic Framework on Occupational Safety and Health for the period 2021 – 2027 and continue updating the directive on the protection of workers from the risks related to carcinogens or mutagens at work. The programme should also support actions to facilitate people’s return to the workplace after long-term sick leave and to better include people who are chronically sick or have a disability in the workforce.
Amendment 403 #
Proposal for a regulation Recital 27 f (new) (27f) The programme should effectively guarantee safe and timely access to sexual and reproductive health and rights (SRHR), goods (e.g. medicines, contraceptives) and services (e.g. sex education, safe abortions).
Amendment 404 #
Proposal for a regulation Recital 30 (30) In order to optimise the added value and impact from investments funded wholly or in part through the budget of the Union, synergies should be sought in particular between the Programme for the Union's action in the field of health and other Union programmes, including those under shared-management, notably the Interreg programme which already addresses cross-border cooperation in the field of health and helps to facilitate the cross-border mobility of patients and health professionals, and to develop access to high quality healthcare through the use of common equipment, shared services and joint facilities in cross-border areas. To maximise those synergies, key enabling mechanisms should be ensured, including cumulative funding in an action from the Programme for the Union's action in the field of health and another Union programme, as long as such cumulative funding does not exceed the total eligible costs of the action. For that purpose, this Regulation should set out appropriate rules, in particular on the possibility to declare the same cost or expenditure on a pro-rata basis to Programme for the Union's action in the field of health and another Union
Amendment 405 #
Proposal for a regulation Recital 30 (30) In order to optimise the added value and impact from investments funded wholly or in part through the budget of the Union, synergies should be sought in particular between the Programme for the Union's action in the field of health and other Union programmes, including those under shared-management and the Union Agencies. To maximise those synergies, key enabling mechanisms should be ensured, including cumulative funding in an action from the Programme for the Union's action in the field of health and another Union programme, as long as such cumulative funding does not exceed the total eligible costs of the action. For that purpose, this Regulation should set out appropriate rules, in particular on the possibility to declare the same cost or expenditure on a pro-rata basis to Programme for the Union's action in the field of health and another Union programme guaranteeing detailed and transparent reporting.
Amendment 406 #
Proposal for a regulation Recital 30 (30) In order to optimise the added value and impact from investments funded wholly or in part through the budget of the Union, synergies should be sought in particular between the Programme for the Union's action in the field of health and other Union programmes, including those under shared-management and the EU agencies. To maximise those synergies and avoid duplications, key enabling mechanisms should be ensured, including cumulative funding in an action from the Programme for the Union's action in the field of health and another Union programme, as long as such cumulative funding does not exceed the total eligible costs of the action. For that purpose, this Regulation should set out appropriate rules, in particular on the possibility to declare the same cost or expenditure on a pro-rata basis to Programme for the Union's action in the field of health and another Union programme.
Amendment 407 #
Proposal for a regulation Recital 31 (31) Given the specific nature of the objectives and actions covered by the Programme, the respective competent
Amendment 408 #
Proposal for a regulation Recital 31 (31) Given the specific nature of the objectives and actions covered by the Programme, the respective competent authorities of the Member States and, in the cross-border context, the Interreg programmes are best placed in some cases to implement the related activities. Those authorities and Interreg programmes, designated by the Member States themselves, should therefore be considered to be identified beneficiaries for the purpose of Article 195 of the Financial Regulation and the grants be awarded to such authorities without prior publication of calls for proposals.
Amendment 409 #
Proposal for a regulation Recital 33 (33) Given the common agreed values of solidarity towards equitable and universal coverage of quality health services as a basis for the Union’s policies in this area and that the Union has a central role to play in accelerating progress on global health challenges19 , the Programme should support the Union’s contribution to international and global health initiatives with a view to improve health,
Amendment 410 #
Proposal for a regulation Recital 33 (33) Given the common agreed values of solidarity towards equitable and universal coverage of quality health services as a basis for the Union’s policies in this area and that the Union has a central role to play in accelerating progress on global health challenges19 , the Programme should, in synergy and complementarity with other relevant Union programmes, support the Union’s contribution to international and global health initiatives
Amendment 411 #
Proposal for a regulation Recital 33 (33) Given the common agreed values of solidarity towards accessible, equitable and universal coverage of quality health services, including in a cross-border context, as a basis for the Union’s policies in this area and that the Union has a central role to play in accelerating progress on global health challenges19 , the Programme should support the Union’s contribution to international and global health initiatives with a view to improve health, address inequalities and increase protection against global health threats. __________________ 19Council conclusions on the EU role in Global Health, 3011th Foreign Affairs Council meeting, Brussels, 10 May 2010.
Amendment 412 #
Proposal for a regulation Recital 34 (34) In order to maximise the effectiveness and efficiency of actions at Union and international level, cooperation should be developed with the Member States and with relevant international organisations such as the United Nations and its specialised agencies, in particular the WHO, the World Bank, as well as with the Council of Europe and the Organisation for Economic Co-operation and Development (OECD) to implement the Programme. Pursuant to Article 94 of Council Decision 2013/755/EU20 , persons and entities established in Overseas Countries and Territories (OCTs) are eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant OCTs are linked. __________________ 20Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union ( ‘Overseas Association Decision’ ) (OJ L 344, 19.12.2013, p. 1).
Amendment 413 #
Proposal for a regulation Recital 36 (36) Cooperation with third countries should be strengthened on the exchange of knowledge and best practices in health systems preparedness and response. The programme should help building a strong and effective partnership between the Union and Africa and prioritise health systems strengthening, universal access to health services and global health research and development in the framework of the EU-Africa Strategy.
Amendment 414 #
Proposal for a regulation Recital 39 a (new) (39a) The preamble to the Paris Agreement acknowledges the “right to health” as a key right; the article 4(1)(f) of the UNFCCC states that all Parties thereto should employ “appropriate methods, for example impacts assessments, formulated and determined nationally with a view to minimising adverse effects on the economy, on public health and on the quality of the environment, of projects or measures undertaken by them to mitigate or adapt climate change".
Amendment 415 #
Proposal for a regulation Recital 39 b (new) (39b) According to the WHO, climate change affects the social and environmental determinants of health- clean air, safe drinking water, sufficient food and secure shelter-and that 250 000 additional deaths, from malnutrition, maladria, diarrhoea and heat stress, are expected every year between 2030 and 2050, with extreme high air temperatures contributing directly to deaths particularly amongst the elderly and vulnerable individuals. Through flood, heatwaves, drought and fires, climate change has a considerable impact on human health, including under nutrition, cardiovascular and respiratory diseases, and vector-borne infections.
Amendment 416 #
Proposal for a regulation Recital 40 Amendment 417 #
Proposal for a regulation Recital 40 Amendment 418 #
Proposal for a regulation Recital 40 (40) Reflecting the importance of tackling climate change in line with the Union's commitments to implement the Paris Agreement and the United Nations
Amendment 419 #
Proposal for a regulation Recital 42 (42) The implementation of the Programme should be such that the responsibilities of the Member States, for the definition of their health policy and for the organisation and delivery of health services and medical care, are respected. However, with a view to improving the complementarity of their health services and their conditions of mobility for patients and healthcare professionals in cross-border areas.
Amendment 420 #
Proposal for a regulation Recital 43 (43) Given the nature and potential scale of cross-border threats to human health, the objective of protecting people in the Union from such threats and to increase crisis prevention and preparedness cannot be sufficiently achieved by the Member States acting alone. In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union, action at Union level can also be taken to support Member States’ efforts in the pursuit of a high level of protection of public health, to improve the availability, sustainability, acceptability, accessibility and affordability in the Union of medicines, medical devices and other
Amendment 421 #
Proposal for a regulation Recital 43 (43) Given the nature and potential scale
Amendment 422 #
Proposal for a regulation Recital 43 (43) Given the nature and potential scale of cross-border threats to human health, the objective of protecting people in the Union from such threats and to increase crisis prevention and preparedness cannot be sufficiently achieved by the Member States
Amendment 423 #
Proposal for a regulation Recital 43 (43) Given the nature and potential scale of cross-border threats to human health, the objective of protecting people in the Union from such threats and to increase crisis prevention and preparedness cannot be sufficiently achieved by the Member States acting alone. In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union, action at Union level can also be taken to support Member States’ efforts in
Amendment 424 #
Proposal for a regulation Article 2 – paragraph 1 – point 3 (3) ‘health crisis’ means any crisis or serious incident arising from a threat of human, animal, plant, food
Amendment 425 #
Proposal for a regulation Article 2 – paragraph 1 – point 3 (3) ‘health crisis’ means any crisis or serious incident arising from a threat of human, animal, plant, food
Amendment 426 #
Proposal for a regulation Article 2 – paragraph 1 – point 4 (4) ‘crisis relevant products’ means products
Amendment 427 #
Proposal for a regulation Article 2 – paragraph 1 – point 4 (4) ‘crisis relevant products’ means products and substances necessary, in the context of a health crisis, to prevent, diagnose or treat a disease and its consequences, as well as other medical products and substances that remain essential during a health crisis, included but not limited to: medicinal products - including vaccines - and their intermediates, active pharmaceutical ingredients and raw materials; medical devices; hospital and medical equipment (such as ventilators, protective clothing and equipment, diagnostic materials and tools); personal protective equipment; disinfectants and their intermediary products and raw materials necessary for their production);
Amendment 428 #
Proposal for a regulation Article 2 – paragraph 1 – point 4 (4) ‘crisis relevant products’ means products and substances necessary, in the
Amendment 429 #
Proposal for a regulation Article 2 – paragraph 1 – point 5 (5) ‘One Health approach’ means an approach which recognises th
Amendment 430 #
Proposal for a regulation Article 2 – paragraph 1 – point 5 (5) ‘One Health approach’ means an approach which recognises
Amendment 431 #
Proposal for a regulation Article 2 – paragraph 1 – point 5 a (new) (5a) The concept of ‘human health’ encompasses absolute respect for life in all its integral dimensions: physical, psychological, emotional and spiritual aspects that are all interconnected, unlike animal health. Such inclusion requires a holistic vision of an approach to comprehensive personal health, which preserves the freedom and dignity intrinsic to the human condition in all phases of life.
Amendment 432 #
Proposal for a regulation Article 2 – paragraph 1 – point 5 a (new) (5a) “Environmental health” means aspects of human health, such as the quality of life, which are determined by the physical, chemical, biological, social, psychosocial and aesthetic factors of our environment;
Amendment 433 #
Proposal for a regulation Article 2 – paragraph 1 – point 9 (9) ‘serious cross-border threat to health’ means a life- threatening or otherwise serious hazard to health of biological, chemical, radiological, nuclear, environmental or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection;
Amendment 434 #
Proposal for a regulation Article 2 – paragraph 1 – point 10 a (new) (10a) "health in all policies principle": policy formulation approach that systematically considers health implications of decisions in all sectors, seeking synergies and avoiding the harmful effects on health of policies outside the health sector, in order to improve population's health and health equity. It develops the capacity of health policy professionals to recognise and support the development goals of other sectors, recognising the interdependent nature of social, economic, and environmental development;
Amendment 435 #
Proposal for a regulation Article 2 – paragraph 1 – point 10 a (new) (10a) ‘Commercial determinant of health’ means strategies and approaches used by the private sector to promote products and choices that are detrimental to health;
Amendment 436 #
Proposal for a regulation Article 2 – paragraph 1 – point 10 a (new) (10a) ‘shortage’ means the temporary unavailability of a medicinal product as a result of an upstream stock shortage and/or a downstream supply shortage;
Amendment 437 #
Proposal for a regulation Article 2 – paragraph 1 – point 10 a (new) (10a) ‘Commercial determinant of health’ means commercial strategies and approaches used to promote products and choices that are detrimental to health.
Amendment 438 #
Proposal for a regulation Article 2 – paragraph 1 – point 10 a (new) (10a) 'independent from industry' means receiving less than 20% of core funding as well as of project funding, respectively, from industry;
Amendment 439 #
Proposal for a regulation Article 2 – paragraph 1 – point 10 b (new) (10b) ‘supply strain’ means that the manufacturer has insufficient quantities of medicines available, resulting in a temporary inability to supply the usual market and a risk of disruption;
Amendment 440 #
Proposal for a regulation Article 2 – paragraph 1 – point 10 c (new) (10c) ‘supply disruption’ means the medicine is manufactured but not distributed to all pharmacies;
Amendment 441 #
Proposal for a regulation Article 2 – paragraph 1 – point 10 d (new) (10d) ‘stock shortage’ means a break in the manufacturing chain of the medicines, which may have several explanations: either the medicines cannot be manufactured or they are not allowed to enter the distribution channel because the quality of the medicines does not fully meet the required standards.
Amendment 442 #
Proposal for a regulation Article 3 – paragraph 1 – introductory part The Programme shall pursue the following general objectives, in keeping with the “One Health” and “Health in all policies” approaches where relevant:
Amendment 443 #
Proposal for a regulation Article 3 – paragraph 1 – introductory part The Programme shall pursue the following general objectives,
Amendment 444 #
Proposal for a regulation Article 3 – paragraph 1 – introductory part The Programme shall pursue the following general objectives, in keeping with the “One Health” approach
Amendment 445 #
Proposal for a regulation Article 3 – paragraph 1 – point -1 (new) (-1) improve the health of people in the Union, including in particular by health promotion, disease prevention and by addressing health inequalities; (This should be the first of the general objectives.)
Amendment 446 #
Proposal for a regulation Article 3 – paragraph 1 – point -1 (new) (-1) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer via the establishment of a European Cancer Institute;
Amendment 447 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) support health promotion, improve health literacy, and disease prevention, reduce health inequalities, improve physical and mental health, protect people in the Union from serious cross-border threats to health;
Amendment 448 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) protect people in the Union from serious cross-border threats to health, including by ensuring equal protection for and full access to health rights for all European Union citizens, by promoting equal opportunities for, and access to, treatment, in a non-discriminatory manner, and by reducing disparities among Member States by allocating the resources needed to achieve this goal;
Amendment 449 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) protect people in the Union from serious cross-border threats to health, including measures to support health promotion and disease prevention, reduce health inequalities, and improve physical and mental health;
Amendment 450 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) support health promotion, health literacy and disease prevention, reduce health inequalities, improve physical and mental health, protect people in the Union from serious cross-border threats to health;
Amendment 451 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) support health promotion and disease prevention, reduce health inequalities, improve physical and mental health, protect people in the Union from serious cross-border threats to health;
Amendment 452 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) support health promotion and prevention, reduce health inequalities, improve physical and mental health and protect people in the Union from serious cross-border threats to health;
Amendment 453 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) protect people in the Union from serious cross-border threats to health; implement better preparedness and coordination within and between Member States as regards health emergencies;
Amendment 454 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) support health promotion and disease prevention and protect people in the Union from serious cross-border threats to health;
Amendment 455 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) protect people in the Union from serious cross-border threats to health and reduce health inequalities among Member States;
Amendment 456 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) support and foster public health and protect people in the Union from serious cross-border threats to health;
Amendment 457 #
Proposal for a regulation Article 3 – paragraph 1 – point 1 (1) protect people in the Union from any serious cross-border threats to health;
Amendment 458 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) support existing and future Union health legislation, improve the equal availability, accessibility and affordability of health care and services in the Union, including of medicines,
Amendment 459 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2)
Amendment 460 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) support existing and future Union health legislation, improve the availability in the Union of medicines, vaccines, medical devices and other
Amendment 461 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) support existing and future Union health legislation, improve the equal availability, accessibility and affordability of health care and services in the Union, including of medicines,
Amendment 462 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) support existing and future Union health legislation, improve the availability in the Union of medicines,
Amendment 463 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) support existing and future Union health legislation, improve the availability in the Union of medicines, medical devices and other
Amendment 464 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) improve the availability in the Union of medicines,
Amendment 465 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2)
Amendment 466 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) improve the availability in the Union of medicines, medical devices and other
Amendment 467 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) improve the availability in the Union, especially in the outermost regions and the overseas countries and territories, of medicines, medical devices and other crisis relevant products, contribute to their affordability, and support innovation;
Amendment 468 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) improve the availability in the Union of medicines, medical devices and other crisis relevant products, contribute to their a
Amendment 469 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) improve the availability in the Union of medicines, medical devices and other crisis relevant products, including products which remain essential in times of crisis, contribute to their affordability, and support innovation;
Amendment 470 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) improve the availability in the Union of medicines, medical devices and other
Amendment 471 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) improve the availability in the Union of medicines, medical devices and other crisis relevant products, contribute to their accessibility and affordability, and support innovation;
Amendment 472 #
Proposal for a regulation Article 3 – paragraph 1 – point 2 (2) improve the availability in the Union of medicines, treatment, medical devices and other crisis relevant products, contribute to
Amendment 473 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) strengthen health systems and the healthcare workforce, including by digital transformation, harmonized education and training and by increased integrated and coordinated work among the Member States, sustained implementation of best practice
Amendment 474 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) strengthen health systems and
Amendment 475 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) strengthen health systems and the healthcare workforce, including by digital transformation, harmonized education and training, and by increased integrated and coordinated work among the Member States, sustained implementation of best
Amendment 476 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) strengthen health systems and the healthcare workforce, including by digital and green transformation, and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and comparable data sharing, to increase the general level of public health and health literacy of the population.
Amendment 477 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) strengthen health systems, their sustainability and the healthcare workforce, including by digital transformation that fully respects the European data protection framework, harmonized education and training, and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and comparable data sharing, to increase the general level of public health.
Amendment 478 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) strengthen health systems and the healthcare workforce, including by digital transformation of all health care services and procedures, and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and data sharing, to increase the general level of public health.
Amendment 479 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) strengthen health systems and the healthcare workforce, including by digital transformation and by increased integrated and coordinated work among the Member States at national, regional and local level, sustained implementation of best practice and data sharing, to increase the general level of public health.
Amendment 480 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) strengthen health systems and the healthcare workforce, including by digital transformation harmonized education and training and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and data sharing, to increase the general level of public health.
Amendment 481 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) strengthen health systems and the healthcare workforce, including by digital transformation and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and comparable and interoperable data sharing, to increase the general level of public health.
Amendment 482 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) strengthen health systems and the healthcare workforce, including by digital transformation and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and data sharing, to ensure interoperablity of their actions and increase the general level of public health.
Amendment 483 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 (3) strengthen health systems, heath infrastructure and the healthcare workforce, including by digital transformation and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and data sharing, to increase the general level of public health.
Amendment 484 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new) (3a) support and strengthen existing and future EU health legislation to improve the availability in the EU of medicines, medical devices and other products that are required in case of shortages, and contribute to their accessibility and affordability;
Amendment 485 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new) (3a) reduce health inequalities between Member States and within Member States while taking into account the “health in all policies” approach;
Amendment 486 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new) (3a) support systematic health impact assessment of other EU policies ensuring a comprehensive, Health in All Policies approach;
Amendment 487 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new) (3a) support action aimed to provide equal access to health care, innovative medical treatment, medicines and medical devices;
Amendment 488 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new) (3a) support actions on integrative, person-centred and outcome-based care and health systems;
Amendment 489 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new) (3a) contribute to disease prevention by addressing key environmental risk factors;
Amendment 490 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new) (3a) make health systems become resilient and better respond to health crises;
Amendment 491 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new) (3a) support the prevention of communicable diseases within the Union;
Amendment 492 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 b (new) (3b) support health promotion, health protection and disease prevention, reduce health inequalities and inequities, improve physical and mental health, addressing in particular the key lifestyle related risk factors with a focus on the Union added value and scale up to healthier and more resilient societies;
Amendment 493 #
Proposal for a regulation Article 3 – paragraph 1 – point 3 b (new) (3b) provide integrated healthcare, accessible at local or regional level, enabling patients to be better supported in their own local and social environment;
Amendment 494 #
Proposal for a regulation Article 4 – paragraph 1 – introductory part The general objectives referred to in Article 3 shall be pursued through the following specific objectives,
Amendment 495 #
Proposal for a regulation Article 4 – paragraph 1 – introductory part The general objectives referred to in Article 3 shall be pursued through the following specific objectives, in keeping with the “One Health” and “Health in all policies” approaches where relevant:
Amendment 496 #
Proposal for a regulation Article 4 – paragraph 1 – point -1 (new) Amendment 497 #
Proposal for a regulation Article 4 – paragraph 1 – point -1 a (new) Amendment 498 #
Proposal for a regulation Article 4 – paragraph 1 – point -1 b (new) (-1b) support implementation of the zero pollution ambition for a toxic-free environment;
Amendment 499 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 (1) strengthen the capability of the Union for prevention, preparedness and response to serious cross-border threats to health, and the management of health crises, including through coordination, provision and deployment of emergency health care capacity, data gathering and surveillance, including by enhancing the capacity of all of the Member States’ health systems to quickly build autonomous mobile hospitals that can treat affected patients near infection hotspots;
Amendment 500 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 (1) in full accordance with Article 168(5) of the Treaty on the Functioning of the European Union, strengthen the capability of the Union, including the EMA and the ECDC, for prevention, preparedness and response to serious cross- border threats to health, and the management of health crises, including through coordination, provision and deployment of emergency health care capacity, data gathering and surveillance;
Amendment 501 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 (1) strengthen the capability of the Union for prevention, preparedness and response to serious cross-border threats to health, and the management of health crises, including through coordination, provision and deployment of emergency health care capacity, data gathering and surveillance, and the coordination of stress testing of national healthcare systems;
Amendment 502 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 (1) strengthen the capability of the Union for prevention, preparedness and response to serious cross-border threats to health, and the management of health crises, including through coordination, provision and deployment of emergency health care capacity, data gathering
Amendment 503 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 (1) strengthen the capability of the Union for prevention, preparedness and response to serious cross-border threats to health, and the management of health crises, including through organization of stress tests, coordination, provision and deployment of emergency health care capacity, data gathering and surveillance;
Amendment 504 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 (1) strengthen the capability of the Union for prevention, preparedness and rapid response to serious cross-border threats to health, and the management of health crises, including through coordination, provision and deployment of emergency health care capacity, data gathering and surveillance;
Amendment 505 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new) (1a) support actions aimed at creating and developing a EU Platform for shortages, based on one harmonised data- collection model and national reporting systems of shortages interoperability, including the full implementation of an effective EU telematics infrastructure that will link data on medicine and supply chain data through interconnection of SPOR and FMD system;
Amendment 506 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new) (1a) Support the strengthening of the competences and resources of the European health agencies namely the ECDC and the EMA, the European Food Safety Authority (EFSA), European Chemicals Agency (ECHA) and EU- OSHA;
Amendment 507 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new) (1a) create and develop a EU Platform for shortages, based on one harmonised data-collection model and national reporting systems of shortages interoperability, including the full implementation of an effective EU telematics infrastructure that will link data on medicine and supply chain data through interconnection of SPOR and FMD system;
Amendment 508 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new) (1a) support the creation, development and implementation of a strategy to tackle shortages of medicines and medical devices in order to ensure all patients in the European Union are able to access treatment;
Amendment 509 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new) (1a) support actions aimed at modernise and digitalise the EU regulatory Network at European and national level;
Amendment 510 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new) (1a) promote online medical and health education in general;
Amendment 511 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 b (new) (1b) support actions aimed at modernise and digitalise the EU regulatory Network at European and national level;
Amendment 512 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 b (new) (1b) modernise and digitalise the EU regulatory Network at European and national level;
Amendment 513 #
Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new) (1a) The objectives of Article 4 shall be delivered in a consistent and transparent way and in a manner that is coordinated with the actions of other Union programmes and agencies.
Amendment 514 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 (2) ensure the availability in the Union of reserves
Amendment 515 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 (2) ensure the availability in the Union of reserves or stockpiles of
Amendment 516 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 (2) ensure the availability in the Union of reserves or stockpiles of crisis relevant products, as well as production capacity, and a reserve of medical, healthcare and support staff to be mobilised in case of a crisis;
Amendment 517 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 (2) ensure the availability in the Union of reserves or stockpiles of crisis relevant products, and a reserve of medical, healthcare and support staff to be mobilised in case of a crisis such as the European Medical Corps;
Amendment 518 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 (2) ensure the availability in the Union of reserves
Amendment 519 #
Proposal for a regulation Article 4 – paragraph 1 – point 2 a (new) (2a) support the creation, development and implementation of a strategy on health personnel in order to ensure an effective public health workforce, with the same high standards across the Union, and promote the excellence of medical and healthcare professionals; to this end, simplify the rules to allow cross-border health workers effective mobility, particularly in the event of a crisis or pandemic;
Amendment 520 #
Proposal for a regulation Article 4 – paragraph 1 – point 3 (3) support actions to ensure appropriate availability, accessibility, sustainability and affordability of
Amendment 521 #
Proposal for a regulation Article 4 – paragraph 1 – point 3 (3) support actions to ensure appropriate availability, accessibility and affordability of
Amendment 522 #
Proposal for a regulation Article 4 – paragraph 1 – point 3 (3) support actions to ensure appropriate availability, accessibility and affordability of crisis relevant products and other necessary health supplies, by improving information systems so as to provide a clear overview of difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling;
Amendment 523 #
Proposal for a regulation Article 4 – paragraph 1 – point 3 (3) strengthen the European Medicines Market and support actions to ensure appropriate availability, accessibility and affordability of crisis relevant products and other necessary health supplies via a strengthened EU joint procurements on treatments and vaccines;
Amendment 524 #
Proposal for a regulation Article 4 – paragraph 1 – point 3 (3) support actions to ensure appropriate availability, accessibility and affordability of crisis relevant products and other necessary health supplies, including at times of non-crisis;
Amendment 525 #
Proposal for a regulation Article 4 – paragraph 1 – point 3 a (new) (3a) support actions to increase research and development, including for unmet medical needs, in full synergy with Horizon Europe and its Missions and Partnerships, including through clinical trials, in the Union of crisis-relevant products, and access to and analysis on data from the use of such products in healthcare systems, including through the European Open Science Cloud;
Amendment 526 #
Proposal for a regulation Article 4 – paragraph 1 – point 3 a (new) (3a) support actions to transform the health sector into a sector that comprises person-centred and outcome-based care and health systems, and where patients are meaningfully involved in the development of solutions and decision making that affect them;
Amendment 527 #
Proposal for a regulation Article 4 – paragraph 1 – point 3 a (new) (3a) provide incentives to increase production of essential APIs and medicines in Europe and to diversify the supply chain to guarantee supply and affordable access at all times;
Amendment 528 #
Proposal for a regulation Article 4 – paragraph 1 – point 3 a (new) (3a) support the research and development of new medicines, medical devices and health products, enhance clinical trials and research based on real world data;
Amendment 529 #
Proposal for a regulation Article 4 – paragraph 1 – point 3 b (new) (3b) develop a transparent framework for fair and equitable access in the short, medium and long term to maximise societal benefit and patient access whilst avoiding unacceptable impact on healthcare budgets, through an inclusive consultative process led by governments, and set up a High Level Strategic Dialogue co-ordinated by the Commission and the participation of all stakeholders including patient organisations, to reflect on and establish concrete and comprehensive strategies to achieve such a framework;
Amendment 530 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 (4) strengthen the effectiveness, accessibility, sustainability and resilience of health systems, including by supporting green and digital transformation,
Amendment 531 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 (4) strengthen the effectiveness, accessibility, sustainability and resilience of health systems, including by supporting digital transformation, the uptake of digital tools and services, systemic reforms, implementation of new care models and to reach universal health coverage objective, encompassing access to sexual and reproductive health and rights, and address social inequalities in health, including gender inequalities;
Amendment 532 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 (4)
Amendment 533 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 (4) strengthen the effectiveness, accessibility, sustainability and resilience
Amendment 534 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 (4) strengthen the effectiveness, accessibility, sustainability and resilience of health systems, including by supporting digital transformation, the uptake of digital tools and services, systemic reforms, implementation of new care models, progressing deinstitutionalisation and moving to community-based care including for older people, and universal health coverage, and address inequalities in health;
Amendment 535 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 (4) strengthen the effectiveness,
Amendment 536 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 a (new) (4a) support the digitalization of health, increasing the skills of citizens and health workers and services, the interoperability of systems and availability of data, ensuring data comparability, to improve the knowledge and evidence on health, support the creation and implementation of a European Health Data Space while respecting citizens´ data protection rights and the Union data protection framework;
Amendment 537 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 a (new) (4a) strengthen and develop the Union health infrastructure by creating new medical care facilities to handle large flows of patients in circumstances of cross-border threats to health and at the same time to continue to assure lifesaving treatment for patients with non- communicable diseases, such as cardiovascular diseases, cancer, paediatric cancer;
Amendment 538 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 a (new) Amendment 539 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 a (new) (4a) enhance the equal and timely access to quality, sustainable and affordable person-centred preventive and curative health care and related care and services for all, with no discrimination or stigma;
Amendment 540 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 a (new) (4a) accompany the Member States in the reformulation of the budgets of their health systems so that they are more clearly redistributed according to the criteria of inequalities in population health;
Amendment 541 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 a (new) (4a) enhance the equal and timely access to quality, sustainable and affordable person-centred preventive and curative health care and related care and services for all;
Amendment 542 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 a (new) (4a) support the development and implementation of a European Electronic Health Record;
Amendment 543 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 b (new) (4b) support the Union’s health related innovation ecosystems in full synergy with Horizon Europe and its Missions and Partnerships to ensure the development and uptake of preventive actions, the next generation of medicines, vaccines and medical devices to meet increasing healthcare challenges and expectations that arise including the ones that come with rare disease prevention, diagnosis, treatment, and innovation;
Amendment 544 #
Proposal for a regulation Article 4 – paragraph 1 – point 4 b (new) (4b) enhance the equal and timely access to quality, sustainable and affordable person-centred preventive and curative health care and related care and services for all, with no discrimination or stigma;
Amendment 545 #
Proposal for a regulation Article 4 – paragraph 1 – point 5 (5) support actions aimed at addressing health inequalities and strengthening health system’s ability to foster protection, disease prevention
Amendment 546 #
Proposal for a regulation Article 4 – paragraph 1 – point 5 (5) support actions aimed at addressing health inequalities and strengthening health system’s ability to foster disease prevention
Amendment 547 #
Proposal for a regulation Article 4 – paragraph 1 – point 5 (5) support actions aimed at addressing health inequalities and strengthening health system’s ability to foster disease prevention
Amendment 548 #
Proposal for a regulation Article 4 – paragraph 1 – point 5 (5) support actions aimed at strengthening health system’s ability to foster disease prevention and health
Amendment 549 #
Proposal for a regulation Article 4 – paragraph 1 – point 5 (5) support actions aimed at addressing health inequalities and strengthening health system’s ability to foster disease prevention and health promotion, patient rights and accessible cross-border healthcare, and promote the excellence of medical and healthcare professionals;
Amendment 550 #
Proposal for a regulation Article 4 – paragraph 1 – point 5 (5) support actions aimed at strengthening health system’s ability to foster disease prevention and health promotion, patient rights and cross-border healthcare, and promote the excellence of medical and healthcare professionals, their education, training and mobility;
Amendment 551 #
Proposal for a regulation Article 4 – paragraph 1 – point 5 (5) support actions aimed at addressing health inequality, strengthening health system’s ability to foster disease prevention and health promotion, patient rights and cross-border healthcare, and promote the excellence of medical and healthcare professionals;
Amendment 552 #
Proposal for a regulation Article 4 – paragraph 1 – point 5 (5) support actions aimed at strengthening health system’s ability to foster disease prevention and health promotion, patient rights and cross-border healthcare, and promote the excellence and cross-border recognition of medical and healthcare professionals;
Amendment 553 #
Proposal for a regulation Article 4 – paragraph 1 – point 5 a (new) (5a) support and promote exchange programmes for healthcare professionals for all specialties and all levels with a view to sharing information and methodologies among countries, thereby benefiting from good experiences;
Amendment 554 #
Proposal for a regulation Article 4 – paragraph 1 – point 5 a (new) (5a) Support actions to ensure the collection of safe blood, and blood components that facilitate a wide range of essential, often live-saving treatments; support actions to raise awareness on the importance of non-remunerated blood donation to this end,
Amendment 555 #
Proposal for a regulation Article 4 – paragraph 1 – point 5 a (new) (5a) support actions aimed at primary prevention through the control of exposure to environmental risk factors;
Amendment 556 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases,
Amendment 557 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the promotion of a healthy lifestyle, surveillance, prevention, early diagnosis and treatment and care of non-communicable diseases, and notably of cancer and cardio-vascular diseases by providing a European strategic Chronic disease framework to support Member States action addressing the commercial determinants of health;
Amendment 558 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer, while addressing its synergies with other major non- communicable diseases such as neurological disorders and supporting the implementation of Europe’s Beating Cancer Plan;
Amendment 559 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and
Amendment 560 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer
Amendment 561 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases,
Amendment 562 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases,
Amendment 563 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action, including policy, for the surveillance, prevention, diagnosis and treatment and care of non- communicable diseases, and notably of cancer by providing a European strategic Chronic disease framework to support Member States action addressing the commercial determinants of health;
Amendment 564 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer, cardiovascular disease, chronic respiratory disease, diabetes, neurological disorders and mental health conditions;
Amendment 565 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases,
Amendment 566 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of
Amendment 567 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases,
Amendment 568 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6)support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer, while addressing its synergies with other major non- communicable diseases, such as neurological disorders;
Amendment 569 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of
Amendment 570 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, the early diagnosis of neurogenerative and other brain diseases, and notably of cancer;
Amendment 571 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, early diagnosis by screening programmes diagnosis and treatment and care of non-communicable diseases, and notably of cancer;
Amendment 572 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 (6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, including major chronic diseases and notably of cancer;
Amendment 573 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 a (new) (6a) support actions to raise awareness chronic neurological disorders, including migraine, to develop ad-hoc strategies to ensure integration patients at work and more broadly in society, as well as to ensure timely and quality diagnosis and access to available treatments;
Amendment 574 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 a (new) (6a) strengthen the programmes to fight against communicable diseases and health threats, as AMR, HIV/AIDS, tuberculosis, hepatitis, influenza, sexually transmitted infections among others, promoting healthy lifestyles, premature detection, access to treatment and long- life care;
Amendment 575 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 a (new) (6a) address the unmet needs of children and adolescents with cancer, and of survivors, through dedicated programmes and plans on Paediatric Cancer, fostering research and access to novel treatment;
Amendment 576 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 a (new) (6a) support action for the elimination of vaccine preventable cancers, such as HPV and Hepatitis B;
Amendment 577 #
Proposal for a regulation Article 4 – paragraph 1 – point 6 b (new) (6b) support actions to raise awareness on migraine as a chronic neurological disorder and its health, societal and economic impact, to develop ad-hoc strategies to ensure integration of migraine patients at work and more broadly in society, as well as to ensure timely and quality diagnosis and access to available treatments;
Amendment 578 #
Proposal for a regulation Article 4 – paragraph 1 – point 7 (7) foster and support the informed, prudent and efficient use of medicines, and in particular of antimicrobials, and
Amendment 579 #
Proposal for a regulation Article 4 – paragraph 1 – point 7 (7) foster and support the prudent and efficient use of medicines, and in particular of antimicrobials,
Amendment 580 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 (8) support the development, implementation and enforcement of Union health legislation and provide high-quality, comparable, and reliable
Amendment 581 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 (8) support the development, implementation and enforcement of Union health legislation and provide high-quality, comparable and reliable data to underpin policy making and monitoring, and promote the use of health impact assessments of relevant policies, as well as dashboards with key metrics to measure progress and reducing inequalities, notably in cancer;
Amendment 582 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 (8) support the development, implementation and enforcement of Union health legislation and provide high-quality, comparable and reliable data to underpin policy making and monitoring,
Amendment 583 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 (8) support the development, implementation
Amendment 584 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 (8) support the development, implementation and enforcement of Union health legislation and provide high-quality, comparable
Amendment 585 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 a (new) (8a) In line with the “One Health” approach and the objectives of the EU Biodiversity Strategy for 2030, support the development, implementation and enforcement of Union legislation to prevent health and biodiversity conservation risks originating from the cross-border and international trade in wild animals kept as pets;
Amendment 586 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 a (new) (8a) Support the development and implementation of EU health-related legislation to develop fair pricing model for essential medicines, taking in account the public money contribution, the real costs of research & development and the added therapeutic value;
Amendment 587 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 a (new) (8a) ensure healthy and safe workplaces across the Union and to support EU-OSHA’s activities and analysis on occupational safety and health.
Amendment 588 #
Proposal for a regulation Article 4 – paragraph 1 – point 8 b (new) (8b) support the development and implementation of an Union harmonized framework for a mechanism for national pricing and reimbursement systems in order to achieve a fair and sustainable pricing and procurement.
Amendment 589 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 (9) support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, the identification of health technologies meant to benefit from a Union assessment, and scaling up networking through the E
Amendment 590 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 (9) support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, the identification of health technologies meant to benefit from a European assessment, and scaling up networking through the European Reference Networks and other transnational networks aiming to increase the coverage of patients and the response to more diseases and health problems;
Amendment 591 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 (9) support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, and scaling up networking through the European Reference Networks and other transnational networks, as well as exchange good practices in order to make it easier for Member States to make the transition towards a healthcare model where aging and chronicity have gained relevance;
Amendment 592 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 (9) support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, and scaling up networking through the European Reference Networks through their extension beyond rare diseases to complex to communicable and non-communicable diseases and other transnational networks;
Amendment 593 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 (9) support integrated work among Member States as well as between neighbouring border regions, and in particular their health systems, including the implementation of high-impact prevention practices, and scaling up networking through the European Reference Networks and other transnational networks;
Amendment 594 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 (9) support
Amendment 595 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 (9) support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, the identification of health technologies meant to benefit from a European assessment, and scaling up networking through the European Reference Networks and other transnational networks;
Amendment 596 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 a (new) (9a) support the creation of excellence networks in the field of communicable and non-communicable diseases to drive forward the prevention, diagnosis and linkage to care, thus helping Europe to deliver on the UN SDGs. These networks should work in close cooperation with civil society and also collect much needed data and contribute to the European Health Data Space. This way, they will help monitor progress towards the fight and towards the elimination of these diseases in line with WHO and UN Goals;
Amendment 597 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 a (new) (9a) support the development of specific European diseases prevention and management guidelines in the area of both communicable and non- communicable diseases, such as cancer, paediatric cancer, cardiovascular diseases, neurodegenerative diseases, respiratory diseases and diabetes, by excellence networks;
Amendment 598 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 a (new) (9a) Create one or more non-profit- making European pharmaceutical establishments of general interest to produce certain priority medicines that are important from a health and strategic point of view;
Amendment 599 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 a (new) (9a) support the prioritisation and implementation of harmonised plans to ensure that all European citizens have access to a heart health check to ensure that detection and treatment of Structural Heart Diseases contribute to more resilient health systems;
Amendment 600 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 a (new) (9a) introduce evaluation indicators for the health European partnership activity so that public funds are spent both legally and efficiently;
Amendment 601 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 a (new) (9 a) advance health literacy through specific programmes in areas such as health promotion, prevention and patient- centred care;
Amendment 602 #
Proposal for a regulation Article 4 – paragraph 1 – point 9 a (new) (9a) support the creation of excellence networks in the field of communicable and non-communicable diseases;
Amendment 603 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 (10) support the Union’s contribution to international and global health initiatives
Amendment 604 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 (10) support the Union’s contribution to international and global health initiatives
Amendment 605 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 (10) support the Union’s contribution to international and global health initiatives
Amendment 606 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 a (new) (10a) support actions aimed at developing and supporting an EU monitoring and early notification platform for shortages, based on EU harmonised data and national reporting systems;
Amendment 607 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 a (new) (10a) ensure that the Union remains a world leader in research and innovation in health care;
Amendment 608 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 a (new) (10a) support policies that guarantee the principle "health in all policies";
Amendment 609 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 b (new) (10b) strengthen public sector participation in health research strategies, in coherence with the Horizon Europe programme, in order to reinforce the necessary resources so that all strategic health research that cannot be done without public support may be carried out;
Amendment 610 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 b (new) (10b) ensure that the Union's health initiatives are people-centred and outcome-driven;
Amendment 611 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 c (new) (10c) Support measures to eliminate vaccine preventable diseases;
Amendment 612 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 a (new) (10a) support actions aimed at creating and developing a EU Platform for shortages, based on one harmonised data- collection model and national reporting systems of shortages interoperability, including the full implementation of an effective EU telematics infrastructure that will link data on medicine and supply chain data through interconnection of SPOR and FMD system;
Amendment 613 #
Proposal for a regulation Article 4 – paragraph 1 – point 10 – point a (new) (a) support actions aimed at modernise and digitalise the EU regulatory Network at European and national level;
Amendment 614 #
Proposal for a regulation Article 5 – paragraph 2 2. The amount referred to in paragraph 1 may be used also for technical and administrative assistance for the implementation of the Programme, such as preparatory, monitoring, control, audit and evaluation activities including corporate information technology systems.
Amendment 615 #
Proposal for a regulation Article 7 – paragraph 1 – point 2 Amendment 616 #
Proposal for a regulation Article 7 – paragraph 1 – point 3 Amendment 617 #
Proposal for a regulation Article 7 – paragraph 1 – point 4 Amendment 618 #
Proposal for a regulation Article 8 – paragraph 1 1. The Programme shall be implemented in direct management in accordance with Regulation (EU, Euratom) 2018/1046 or in indirect management with the bodies referred to in Article 62(1) (c) of Regulation (EU, Euratom) 2018/1046, to ensure there is no overlap or duplication with other funding programmes at the Union level.
Amendment 619 #
Proposal for a regulation Article 8 – paragraph 4 a (new) 4a. Where implementation and monitoring of the programme is carried out by civil society, including participation in institutional structures, and while recognising the specific contribution of patients and their organisations to the programme’s objectives, a sustainable funding scheme to ensure the fulfilment of these roles shall be guaranteed.
Amendment 620 #
Proposal for a regulation Article 9 a (new) Article 9a Award criteria The award criteria shall be defined in the work programmes referred to in Article 18 and in the calls for proposals taking into account, to the extent applicable, the following elements: (a) consistency with specific objectives provided in Article 4; (b) contribution to the accessibility and affordability of health system; (c) cross-border dimension; (d) contribution to digital transformation; (e) social impact (benefits and costs); (f) consistency with provisions of annex 1; (g) contribution to prevention of diseases and notably to cancer; (h) contribution to access to medicine; (i) maturity of the action in the project development; (j) soundness of the implementation plan proposed.
Amendment 621 #
Proposal for a regulation Article 9 a (new) Article 9a Beneficiaries eligible for grants 1. Grants for the functioning of patient organisations at Union level may be awarded to European patient organisations which comply with all of the following conditions: (a) they are non-governmental, non- profit-making, and have as their primary objectives and activities the promotion and protection of the health, and representation of the community they represent in the European-level policy processes; (b) they are mandated to represent the interests of patients at Union level by organisations in at three fourths of the Member States that are representative, in accordance with national rules or practice, of patient organisations, and that are active at regional or national level.
Amendment 622 #
Proposal for a regulation Article 9 b (new) Article 9b Co-financing rate The amount of Union financial assistance shall not exceed 85 % of the total eligible cost.
Amendment 623 #
Proposal for a regulation Article 11 – paragraph 1 a (new) The total amount used for blending operations shall not be higher than 10 % of the financial envelope specified in Article 5.
Amendment 624 #
Proposal for a regulation Article 12 – paragraph 3 a (new) A reliable and efficient mechanism shall be created in order to avoid any duplication of funding and to ensure synergies between the different Union programmes and policies that are pursuing health objectives. All the data on funding operations and actions financed under different Union programmes and funds shall be centralised under this mechanism. It shall follow the principles of transparency and accountability and shall allow better monitoring and evaluation of actions pursuing health objectives.
Amendment 625 #
Proposal for a regulation Article 14 – paragraph 1 – point a – introductory part (a) legal entities shall be established in any of the following countries:
Amendment 626 #
Proposal for a regulation Article 14 – paragraph 1 – point a – point ii Amendment 627 #
Proposal for a regulation Article 14 – paragraph 1 – point a – point iii Amendment 628 #
Proposal for a regulation Article 14 – paragraph 1 – point b (b) any legal entity created under Union law or any international organisation such as public authorities, public sector bodies, health establishments, research institutes, universities and higher education establishments, patient associations etc.;
Amendment 629 #
Proposal for a regulation Article 14 – paragraph 3 3. Legal entities established in a third country which is not associated to the Programme should
Amendment 630 #
Proposal for a regulation Article 14 – paragraph 5 5. Under the Programme, direct grants may be awarded without a call for proposals to fund actions having a clear Union added value co-financed by the local, regional and national competent authorities that are responsible for health in the Member States or in the third countries associated to the Programme, relevant international health organisations or by Interreg programmes, public sector bodies and non-governmental bodies, acting individually or as a network, mandated by those competent authorities.
Amendment 631 #
Proposal for a regulation Article 14 – paragraph 6 6. Under the Programme, direct grants may be awarded without a call for proposals to European Reference Networks. Direct grants may also be awarded to other transnational networks or Interreg programmes set out in accordance with EU rules.
Amendment 632 #
Proposal for a regulation Article 14 – paragraph 6 a (new) 6a. Adequate funding shall be ensured to consolidate and expand the ERN model of cross-border healthcare by securing the provision of a range of clinical services through different channels, including online second opinion and specialist advice for patients on treatment and management and virtual “online out- patient” clinics.
Amendment 633 #
Proposal for a regulation Article 14 – paragraph 6 a (new) 6a. Adequate funding shall be ensured to consolidate and expand the ERN model of cross-border healthcare by securing the provision of a range of clinical services through different channels, including online second opinion and specialist advice for patients on treatment and virtual “online out-patient” clinics.
Amendment 634 #
Proposal for a regulation Article 14 – paragraph 7 – point ii (ii) they work in the public health area, pursue at least one of the specific objectives of the Programme and
Amendment 635 #
Proposal for a regulation Article 14 – paragraph 7 – point iii (iii) they are
Amendment 636 #
Proposal for a regulation Article 14 – paragraph 7 a (new) 7a. The total amount of direct grants shall not be higher than 100.000.000 EURO.
Amendment 637 #
Proposal for a regulation Article 16 – paragraph 1 The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases
Amendment 638 #
Proposal for a regulation Article 16 – paragraph 1 The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion,
Amendment 639 #
Proposal for a regulation Article 16 – paragraph 1 The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases, as well as relevant Union decentralised agencies and other relevant stakeholders, such as representatives of civil society organisations, and in particular patients’ organisations, on the work plans established for the Programme and its priorities and strategic orientations and its implementation.
Amendment 640 #
Proposal for a regulation Article 16 – paragraph 1 The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases on the work plans established for the Programme and its priorities and strategic orientations and its implementation. Consideration should be given to promoting synergies between European funds and national funds/resources to ensure long-term effectiveness and sustainability of the actions.
Amendment 641 #
Proposal for a regulation Article 16 – paragraph 1 The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases on the work plans established for the Programme and its priorities and strategic orientations and its implementation. The involvement of civil society representatives, including patient representatives, shall also be ensured.
Amendment 642 #
Proposal for a regulation Article 16 – paragraph 1 The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases, as well as representatives of civil society organisations, including patients’ organisations, on the work plans established for the Programme and its priorities and strategic orientations and its implementation.
Amendment 643 #
Proposal for a regulation Article 16 – paragraph 1 The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases, the Union agencies, the external independent experts on the work p
Amendment 644 #
Proposal for a regulation Article 16 – paragraph 1 The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases
Amendment 645 #
Proposal for a regulation Article 17 – paragraph 1 – introductory part 1. The Commission may, by means of implementing acts, lay down rules on:
Amendment 646 #
Proposal for a regulation Article 17 – paragraph 1 a (new) The Commission shall, by means of a delegated act, lay down detailed rules regarding the spending of the resources mentioned in Article 6. The delegated act shall be adopted in accordance with Article 24 and shall include detailed rules regarding the rules from this Regulation and Regulation [European Union Recovery Instrument] to be applied, the implementation through annual work programmes and the reimbursement plan.
Amendment 647 #
Proposal for a regulation Article 18 – paragraph 1 The Programme shall be implemented by annual work programmes referred to in Article 110 of Regulation (EU, Euratom) 2018/1046. Work programmes shall set out, where applicable, the overall amount reserved for blending operations.
Amendment 648 #
Proposal for a regulation Article 18 – paragraph 1 a (new) The work programmes shall be adopted by the Commission by means of a delegated act. Those delegated acts shall be adopted in accordance Article 24 of this Regulation.
Amendment 649 #
Proposal for a regulation Article 19 – paragraph 1 1. Indicators to
Amendment 650 #
Proposal for a regulation Article 20 – paragraph 1 a (new) 1a. Stress tests shall be introduced to assess the resilience of health systems in emergencies with a view to providing an effective means of countering shortages in the event of pandemics and identifying structural risk factors that create shortages.
Amendment 651 #
Proposal for a regulation Article 20 – paragraph 2 2. The interim evaluation of the
Amendment 652 #
Proposal for a regulation Article 20 – paragraph 2 2. The interim evaluation of the Programme shall be performed once there is sufficient information available about their implementation, but not later than four years after the start of the implementation and before any decision is taken on future work programmes. The results of the interim evaluation shall be made public.
Amendment 653 #
Proposal for a regulation Article 20 – paragraph 2 2. The interim evaluation of the Programme shall be performed once there is sufficient information available about their implementation, but not later than
Amendment 654 #
Proposal for a regulation Article 20 – paragraph 2 2. The interim evaluation of the Programme shall be performed once there is sufficient information available about their implementation, but not later than four years after the start of the implementation and before any decision is taken on future work programmes. The results of the interim evaluation shall be made public.
Amendment 655 #
Proposal for a regulation Article 20 – paragraph 2 2. The interim evaluation of the Programme shall be performed and submitted to the European Parliament and to the Council once there is sufficient information available about their implementation, but not later than four years after the start of the implementation.
Amendment 656 #
Proposal for a regulation Article 20 – paragraph 3 3. At the end of the implementation period, but no later than four years after the end of the period specified in Article 1, a final evaluation shall be carried out by the Commission and submitted to the European Parliament and to the Council.
Amendment 657 #
Proposal for a regulation Article 20 – paragraph 4 4. The Commission shall publish and communicate the conclusions of the evaluations accompanied by its
Amendment 658 #
Proposal for a regulation Annex I – point a – point ii (ii) Critical health infrastructure relevant in the context of health crises, tools, structures, processes, production, storage and laboratory capacity, including tools for surveillance, modelling, forecast, prevention and management of outbreaks
Amendment 659 #
Proposal for a regulation Annex I – point a – point ii (ii) Critical health infrastructure relevant in the context of health crises, tools, structures, processes, production and laboratory capacity, including tools for surveillance, modelling, forecast, prevention and management of outbreaks and relevant medical products.
Amendment 660 #
Proposal for a regulation Annex I – point a – point ii (ii) Critical health infrastructure relevant in the context of health crises, tools, mechanisms, structures, processes, production and laboratory capacity, including tools for surveillance, modelling, forecast, prevention and management of outbreaks.
Amendment 661 #
Proposal for a regulation Annex I – point a – point ii a (new) (iia) Development of a single pan- European digital mechanism for better reporting, notifying and monitoring of potential shortages, by starting from supporting the implementation of a European common data repository and interconnection between regulatory information on medicines, contained in SPOR, with supply chain data, in FMD system, in all Member States;
Amendment 662 #
Proposal for a regulation Annex I – point a – point ii a (new) (iia) Development of a single pan- European digital mechanism for better reporting, notifying and monitoring of potential shortages, by starting from supporting the implementation of a European common data repository and interconnection between regulatory information on medicines, contained in SPOR, with supply chain data, in FMD system, in all Member States;
Amendment 663 #
Proposal for a regulation Annex I – point a – point ii a (new) (iia) Development of a single pan- European digital mechanism for better reporting, notifying and monitoring of potential shortages, by starting from supporting the implementation of a European common data repository and interconnection between regulatory information on medicines, contained in SPOR, with supply chain data, in FMD system, in all Member States;
Amendment 664 #
Proposal for a regulation Annex I – point a – point ii a (new) (iia) coordination of a collaborative and open approach in the field of research and innovation, driving research towards outcomes including needed medicines, vaccines, medical devices and equipment;
Amendment 665 #
Proposal for a regulation Annex I – point a – point ii a (new) (iia) Support the building of hospitals in the less developed regions of the Union; the EU4Health Programme should participate in synergy and complementarity with the funds from the cohesion policy;
Amendment 666 #
Proposal for a regulation Annex I – point a – point ii a (new) (iia.) Local production of medicinal plants in the Member States;
Amendment 667 #
Proposal for a regulation Annex I – point a – point ii b (new) (iib) Strengthening EU institutions, notably EMA and ECDC, to play a bigger role in managing response to cross-border heath crises and preventing medicine and medical devices shortages.
Amendment 668 #
Proposal for a regulation Annex I – point a – point ii b (new) (iib.) Production of active ingredients and generics within the European Union to reduce the Member States’ dependence on certain third countries.
Amendment 669 #
Proposal for a regulation Annex I – point b (b) Transfer, adaptation and roll-out of
Amendment 670 #
Proposal for a regulation Annex I – point b (b) Transfer, adaptation and roll-out of best practices and innovative solutions with established Union level added-value between Member States, and country- specific tailor made support to countries, or groups of countries or regions, with the highest needs, through the funding of specific projects including twinning, expert advice and peer support.
Amendment 671 #
Proposal for a regulation Annex I – point c – point i (i) Surveys, studies, centralized and accessible collection of data and statistics, methodologies, classifications, microsimulations, pilots, indicators, knowledge brokering and bench mark exercises;
Amendment 672 #
Proposal for a regulation Annex I – point c – point i (i) Surveys, studies, centralized and accessible collection of data and statistics, methodologies, classifications, microsimulations, pilots, indicators, knowledge brokering and benchmark exercises;
Amendment 673 #
Proposal for a regulation Annex I – point c – point i (i) Surveys, studies, centralized and accessible collection of data and statistics, methodologies, classifications, microsimulations, pilots, indicators, knowledge brokering and benchmark exercises;
Amendment 674 #
Proposal for a regulation Annex I – point c – point i (i) Surveys, studies, centralized and accessible collection of data and statistics, methodologies, classifications, microsimulations, pilots, indicators, knowledge brokering and benchmark exercises;
Amendment 675 #
Proposal for a regulation Annex I – point c – point i (i) Surveys, studies, collection of centralised and accessible data and statistics, methodologies, classifications, microsimulations, indicators, knowledge brokering and benchmark exercises;
Amendment 676 #
Proposal for a regulation Annex I – point c – point i (i) Surveys, studies, collection of data and statistics, methodologies, classifications, microsimulations, pilots, indicators, knowledge brokering and benchmark exercises;
Amendment 677 #
Proposal for a regulation Annex I – point c – point iii (iii) Expert groups and panels, including all relevant stakeholders, providing advice, evaluation, data and information to support health policy development and implementation; such expert groups and panels should include representatives of patients and other relevant civil society organisations;
Amendment 678 #
Proposal for a regulation Annex I – point c – point iii (iii) Expert groups and panels providing advice, data and information to support health policy development and implementation; such expert groups and panels shall include independent patient organisations and other relevant independent civil society organisations;
Amendment 679 #
Proposal for a regulation Annex I – point c – point iii (iii) Expert groups and panels, providing advice, data and information to support health policy development and implementation; such expert groups and panels shall include representatives of patients and other relevant civil society organisations;
Amendment 680 #
Proposal for a regulation Annex I – point c – point iii (iii) Expert groups and panels providing advice, data and information to support health policy development and implementation, including the follow-up evaluation of the implementation of health policies;
Amendment 681 #
Proposal for a regulation Annex I – point c – point iii (iii) Expert groups and panels, incorporating all of the relevant stakeholders, providing advice, evaluations, data and information to support health policy development and implementation;
Amendment 682 #
Proposal for a regulation Annex I – point c – point iii (iii) Expert groups and panels, including all relevant stakeholders, providing advice, evaluation, data and information to support the health policy development and implementation;
Amendment 683 #
Proposal for a regulation Annex I – point c – point iii (iii) Expert groups and panels, including all relevant stakeholders, providing advice, evaluation, data and information to support health policy development and implementation;
Amendment 684 #
Proposal for a regulation Annex I – point c – point iii (iii) Expert groups and panels, including all relevant stakeholders, providing advice, evaluation, data and information to support health policy development and implementation;
Amendment 685 #
Proposal for a regulation Annex I – point c – point iii (iii) Expert groups and panels providing advice, data and information to support and evaluate health policy development and implementation;
Amendment 686 #
Proposal for a regulation Annex I – point c – point iii a (new) (iiia) Setting up and management of a High Level Pharmaceuticals Forum at political level composed of authorities and relevant health care stakeholders to define priorities and concrete measures to be implemented at technical level;
Amendment 687 #
Proposal for a regulation Annex I – point c – point iii a (new) (iiia) Setting up and management of a High Level Pharmaceuticals Forum at political level composed of authorities and relevant healthcare stakeholders to define priorities and concrete measures to be implemented at technical level;
Amendment 688 #
Proposal for a regulation Annex I – point c – point iii a (new) (iiia) Setting up and management of a High Level Pharmaceuticals Forum at political level composed of authorities and relevant healthcare stakeholders to define priorities and concrete measures to be implemented at technical level;
Amendment 689 #
Proposal for a regulation Annex I – point c – point iii a (new) (iii a) Setting up and management of a High Level Pharmaceuticals Forum at political level composed of authorities and relevant healthcare stakeholders to define priorities and concrete measures to be implemented at technical level;
Amendment 690 #
Proposal for a regulation Annex I – point c – point iii a (new) (iiia) Setting up and management of a High Level Pharmaceuticals Forum at political level composed of authorities and relevant health stakeholders to define priorities and concrete measures to be implemented at technical level;
Amendment 691 #
Proposal for a regulation Annex I – point c – point iii a (new) (iiia.) The creation and management of a policy-oriented Pharmaceutical Forum comprising health authorities and stakeholders, with a view to defining specific priorities and measures to be implemented at a technical level;
Amendment 692 #
Proposal for a regulation Annex I – point c – point iv (iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on "Consumer Safety" and on "Health, Environmental and Emerging Risks", as well as the Expert Group on "Health Systems Performance Assessment".
Amendment 693 #
Proposal for a regulation Annex I – point c – point iv (iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on "Consumer Safety" and on "Health, Environmental and Emerging Risks" and on "Healthcare systems performance" .
Amendment 694 #
Proposal for a regulation Annex I – point c – point iv (iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on "Consumer Safety" and on "Health, Environmental and Emerging Risks" and on "Healthcare systems performance".
Amendment 695 #
Proposal for a regulation Annex I – point c – point iv (iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on "Consumer Safety" and on "Health, Environmental and Emerging Risks"
Amendment 696 #
Proposal for a regulation Annex I – point c – point iv (iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on "Consumer Safety" and on "Health, Environmental and Emerging Risks"
Amendment 697 #
Proposal for a regulation Annex I – point c – point iv (iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on "Consumer Safety"
Amendment 698 #
Proposal for a regulation Annex I – point c – point iv (iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on ‘Consumer Safety’ and on ‘Health, Environmental and Emerging Risks’, and the Expert Group on Health Systems Performance Assessment.
Amendment 699 #
Proposal for a regulation Annex I – point c – point iv a (new) (iva) Development and operation of databases and digital tools and their interoperability of health data, including where appropriate with other sensing technologies, such as space-based technology and to support access to and analysis of data from real world healthcare settings; support the implementation of artificial intelligence and other tools in order to improve the quality of health data;
Amendment 700 #
Proposal for a regulation Annex I – point d – introductory part (d) Development and implementation of Union health legislation and action, and of Union environmental legislation and its impact on public health, in particular through support to:
Amendment 701 #
Proposal for a regulation Annex I – point d – introductory part (d)
Amendment 702 #
Proposal for a regulation Annex I – point d – introductory part (d) Development and implementation of Union health legislation and action, for the protection and promotion of health, in particular through support to:
Amendment 703 #
Proposal for a regulation Annex I – point d – introductory part (d)
Amendment 704 #
Proposal for a regulation Annex I – point d – introductory part (d)
Amendment 705 #
Proposal for a regulation Annex I – point d – introductory part (d)
Amendment 706 #
Proposal for a regulation Annex I – point d – introductory part (d)
Amendment 707 #
Proposal for a regulation Annex I – point d – point i (i) Implementation, enforcement, monitoring of Union health legislation
Amendment 708 #
Proposal for a regulation Annex I – point d – point i (i)
Amendment 709 #
Proposal for a regulation Annex I – point d – point i (i) Implementation, enforcement, monitoring of Union health legislation, including Pharmacovigilance legislation, and action; and technical support to the implementation of legal
Amendment 710 #
Proposal for a regulation Annex I – point d – point i (i) Implementation, enforcement, monitoring of Union health legislation and action, and of Union environmental legislation and its impact on public health; and technical support to the implementation of legal requirements;
Amendment 711 #
Proposal for a regulation Annex I – point d – point i (i) Implementation, enforcement, monitoring of Union health legislation and action for the protection and promotion of health; and technical support to the implementation of legal requirements;
Amendment 712 #
Proposal for a regulation Annex I – point d – point i (i) Implementation, enforcement, monitoring and improvement of Union health legislation and action
Amendment 713 #
Proposal for a regulation Annex I – point d – point i a (new) (ia) Strengthening of European Health agencies namely the European Centre for Disease Prevention and Control Centre(ECDC), the European Medicines Agency (EMA), the European Food Safety Authority (EFSA), European Chemicals Agency (ECHA) and European Agency for Safety and Health at Work(EU-OSHA).
Amendment 714 #
Proposal for a regulation Annex I – point d – point i a (new) (ia) development of a fair pricing model for essential medicines, taking in account the public money contribution, the real costs of research & development and the added therapeutic value;
Amendment 715 #
Proposal for a regulation Annex I – point d – point i b (new) (ib) development of an harmonized framework for a mechanism for national pricing and reimbursement systems
Amendment 716 #
Proposal for a regulation Annex I – point d – point iv (iv) Development and operation of databases and digital tools and their interoperability, including where appropriate with other sensing technologies, such as space-based, and to support cross-border exchange, access to and analysis of data from real world healthcare settings, including within the framework of the European health data space and the EMVS (European Medicines Verification System) data repositories at aggregated level as a tool to oversee shortages while ensuring respect of personal data in line with GDPR and ensuring appropriate cyber security solutions are deployed;
Amendment 717 #
Proposal for a regulation Annex I – point d – point iv (iv) Development
Amendment 718 #
Proposal for a regulation Annex I – point d – point iv (iv) Development
Amendment 719 #
Proposal for a regulation Annex I – point d – point iv (iv) Development
Amendment 720 #
Proposal for a regulation Annex I – point d – point iv (iv) Development and operation and maintenance of databases and digital tools and their interoperability, including already established project such as creation of a central common repository for all medicines in Europe and SPOR implementation, where appropriate with other sensing technologies, such as space- based;
Amendment 721 #
Proposal for a regulation Annex I – point d – point iv (iv) Development
Amendment 722 #
Proposal for a regulation Annex I – point d – point v (v) Auditing
Amendment 723 #
Proposal for a regulation Annex I – point d – point v (v) Auditing
Amendment 724 #
Proposal for a regulation Annex I – point d – point v (v) Auditing
Amendment 725 #
Proposal for a regulation Annex I – point d – point v (v) Auditing
Amendment 726 #
Proposal for a regulation Annex I – point d – point viii (viii) Networking by non-governmental organisations and their involvement in projects covered by the Programme and the evaluation of the implementation of the programme;
Amendment 727 #
Proposal for a regulation Annex I – point d – point ix (ix) Collaboration with third countries on the areas covered by the Programme especially with African countries in the framework of the EU- Africa Strategy;
Amendment 728 #
Proposal for a regulation Annex I – point d – point ix (ix) Collaboration with third countries on the areas covered by the Programme;
Amendment 729 #
Proposal for a regulation Annex I – point d – point ix a (new) (ixa) Capacity building activities for, and resourcing of, patient organizations to increase patients’ contribution to designing and implementing health policies;
Amendment 730 #
Proposal for a regulation Annex I – point d – point x (x) National contact points providing guidance, information and assistance related the promotion and the implementation of Union health legislation and of the Programme
Amendment 731 #
Proposal for a regulation Annex I – point d – point xi (xi) Stakeholders in view of transnational and regional cooperation.
Amendment 732 #
Proposal for a regulation Annex I – point d – point xi a (new) (xia) Cross-border efforts to prevent health and conservation risks originating from poorly regulated trade in and keeping of wild animals and domestic pets;
Amendment 733 #
Proposal for a regulation Annex I – point d – point xi a (new) (xia) Cross-border cooperation to ensure access to rapid treatment to all patients across the Union, particularly in case of rare disease;
Amendment 734 #
Proposal for a regulation Annex I – point d – point xi a (new) (xia) effective public communication, awareness campaigns and stakeholder-led projects, including prevention and fight to disinformation;
Amendment 735 #
Proposal for a regulation Annex I – point d – point xi a (new) (xia) Awareness raising campaigns for the general population as well as targeted groups;
Amendment 736 #
Proposal for a regulation Annex I – point d – point xi a (new) (xia) Systematic health impact assessment of other Union policy actions;
Amendment 737 #
Proposal for a regulation Annex I – point d – point xi a (new) (xia) Systematic health impact assessment of other EU policy action;
Amendment 738 #
Proposal for a regulation Annex I – point d – point xi a (new) (xia) Population information and awareness campaigns;
Amendment 739 #
Proposal for a regulation Annex I – point d – point xi b (new) (xib) Population information and awareness campaigns and stakeholder-led projects.
Amendment 740 #
Proposal for a regulation Annex I – point d a (new) (da.)Development of the capacity and resources of patients’ organisations to increase patients’ contribution to health policy planning and implementation.
Amendment 741 #
Proposal for a regulation Annex I – point e – introductory part (e) Structural
Amendment 742 #
Proposal for a regulation Annex I – point e – point i (i) Establishment
Amendment 743 #
Proposal for a regulation Annex I – point e – point i (i) Establishment and support of a mechanism to develop, procure
Amendment 744 #
Proposal for a regulation Annex I – point e – point i a (new) (ia) Establishment of an EU contingency reserve of medicines of major therapeutic interest and medical equipment to be triggered and monitored by the European Health Reaction Mechanism(EHRM);
Amendment 745 #
Proposal for a regulation Annex I – point e – point ii (ii) Establishment and management of EU reserves
Amendment 746 #
Proposal for a regulation Annex I – point e – point ii (ii) Establishment and management of EU reserves
Amendment 747 #
Proposal for a regulation Annex I – point e – point iv (iv) Procurement of goods and services, based on the most economically advantageous tender (MEAT) criteria, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 748 #
Proposal for a regulation Annex I – point e – point iv (iv) Procurement of goods and services, using the MEAT criteria in particular, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 749 #
Proposal for a regulation Annex I – point e – point iv (iv) Procurement, of goods and services, including MEAT criteria, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 750 #
Proposal for a regulation Annex I – point e – point iv (iv) Procurement of goods and services, including MEAT criteria, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 751 #
Proposal for a regulation Annex I – point e – point iv (iv) Procurement of goods and services, including MEAT criteria, necessary for the prevention and
Amendment 752 #
Proposal for a regulation Annex I – point e – point iv (iv) Procurement of goods and services including MEAT criteria, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 753 #
Proposal for a regulation Annex I – point e – point v (v) Establishment and operation of a Union health response mechanism coordinated by the ECDC and with the assistance of other health-related agencies (EMA, EFSA, ECHA, EEA) of a Union reserve of medical and healthcare staff and experts and of a mechanism to deploy such staff and experts as necessary to prevent or respond to a health crisis throughout the Union
Amendment 754 #
Proposal for a regulation Annex I – point e – point v (v) Establishment and operation of a Union reserve of medical and healthcare staff and experts and of a mechanism to deploy such staff and experts as necessary to prevent or respond to a health crisis throughout the Union, including in the outermost regions and the overseas countries and territories; establishment and operation of a Union Health Emergency team to provide expert advice and technical assistance on request by the Commission in the case of a health crisis.
Amendment 755 #
Proposal for a regulation Annex I – point e – point v a (new) (va) Strengthening mechanisms that ensure the availability of blood components, organs, tissues and cells at European level;
Amendment 756 #
Proposal for a regulation Annex I – point f – point i (i)
Amendment 757 #
Proposal for a regulation Annex I – point f – point ii a (new) (iia) Support tools and platforms to collect real-world data on the safety, effectiveness and impact of vaccines after use while guaranteeing robust evidence generation in the pre-approval phase;
Amendment 758 #
Proposal for a regulation Annex I – point f – point iii (iii) Support and/or procure emergency
Amendment 759 #
Proposal for a regulation Annex I – point f – point iii (iii) Support and/or procure emergency
Amendment 760 #
Proposal for a regulation Annex I – point f – point iii (iii) Support and/or procure emergency
Amendment 761 #
Proposal for a regulation Annex I – point f – point iii (iii) Support and/or procure emergency production of medical countermeasures, including essential chemicals and active substances, and the financing of cooperation on emergency health technology assessments and clinical trials; and secure financing of exceptional measures to free capacity of lines that can be utilised to provide ICU medicines;
Amendment 762 #
Proposal for a regulation Annex I – point f – point iv (iv) Preventive actions to protect all citizens, taking into consideration and paying special attention to vulnerable and risk groups from health threats and actions to adjust the response to and management of
Amendment 763 #
Proposal for a regulation Annex I – point f – point iv (iv) Preventive actions to protect vulnerable groups from health threats and actions to adjust the response to and management of crisis to the needs of those vulnerable groups, with the commitment to leave no one behind, such as while safeguarding continued access to quality care and patient safety, and securing basic care for non-communicable and chronic disease patients, including for those in need of palliative care and pain management treatment;
Amendment 764 #
Proposal for a regulation Annex I – point f – point iv (iv) Preventive actions to protect vulnerable groups from health threats and actions to adjust the response to and management of crisis to the needs of those vulnerable groups, with the commitment to leave no one behind, such as while safeguarding continued access to quality care and patient safety, and securing basic care for chronic disease patients in need of palliative care and pain management treatment;
Amendment 765 #
Proposal for a regulation Annex I – point f – point v (v) Actions to address the collateral health consequences of a health crisis, in particular those on mental health,
Amendment 766 #
Proposal for a regulation Annex I – point f – point v (v) Actions to address and manage the collateral
Amendment 767 #
Proposal for a regulation Annex I – point f – point v (v) Actions to address and manage the collateral health consequences of a health crisis, in particular those on mental health, on patients suffering from chronic diseases and other vulnerable groups, such as people living with addiction, with HIV/AIDS, tuberculosis or in socially vulnerable situations;
Amendment 768 #
Proposal for a regulation Annex I – point f – point v a (new) (va.) With patient safety as a top priority, actions to facilitate the availability of accessible and affordable telemedicine services for all patients throughout Europe, and to support digital literacy and a transition to telemedicine, home administration of treatment and medication, and implementation of preventative and self-care plans, while involving patients’ organisations in evaluating, identifying and implementing the best possible solutions in terms of continued access to high-quality care and treatment;
Amendment 769 #
Proposal for a regulation Annex I – point f – point v a (new) (va) While keeping patient safety a top priority, actions to facilitate the availability of accessible and affordable telemedicine services throughout Europe to all patients, support digital literacy and a transition to telemedicine, at home administration of treatment and medication and implementation of preventative and self-care plans, while involving patients’ organisations in evaluating, identifying and implementing the best possible solutions to continued access to quality care and treatment;
Amendment 770 #
Proposal for a regulation Annex I – point f – point v a (new) (va) While keeping patient safety a top priority, actions to facilitate the availability of accessible and affordable telemedicine services throughout Europe to all patients, support digital literacy and a transition to telemedicine, at-home administration of treatment and medication and implementation of preventative and self-care plans, while involving patients’ organisations in evaluating, identifying and implementing the best possible solutions to continued access to quality care and treatment;
Amendment 771 #
Proposal for a regulation Annex I – point f – point v a (new) (v a) Actions to support e-health, the transition to telemedicine, the use of digital health tools, enabling patients to use e-health solutions and implement self- care plans, empowering citizens and patients to self-manage as regards their health;
Amendment 772 #
Proposal for a regulation Annex I – point f – point v a (new) (va) Support actions to foster innovation on in repurposing, reformulation and combinations of off- patent medicines that that deliver relevant improvements for patients, healthcare professionals and/or healthcare systems;
Amendment 773 #
Proposal for a regulation Annex I – point f – point v a (new) (va) Actions to support harmonised implementation of electronic product information in all Members States;
Amendment 774 #
Proposal for a regulation Annex I – point f – point v b (new) (vb) Actions to support harmonised implementation of electronic product information in all Members States , transition to telemedicine, at-home administration of medication and implementation of preventative and self- care plans, where possible and appropriate;
Amendment 775 #
Proposal for a regulation Annex I – point f – point v b (new) (vb) Actions to support harmonised implementation of electronic product information in all Members States, transition to telemedicine, at-home administration of medication and implementation of preventative and self- care plans, where possible and appropriate;
Amendment 776 #
Proposal for a regulation Annex I – point f – point vi (vi) Actions to strengthen surge capacity, research, development, laboratory capacity, production and deployment of
Amendment 777 #
Proposal for a regulation Annex I – point f – point vii (vii) Establishment and operation of a mechanism for cross-sectorial One-Health
Amendment 778 #
Proposal for a regulation Annex I – point f – point vii a (new) (viia) Establishment and operation of a mechanism responsible for procurement and development of countermeasures against biological threats, including bioterrorism, and chemical, nuclear and radiological threats;
Amendment 779 #
Proposal for a regulation Annex I – point f – point viii (viii) Actions to support investigation, risk assessment and risk management work related to all medicinal products but with focus to priority, science and current taking into account existing knowledge on the link between animal health, environmental factors, and human diseases, including during health crises.
Amendment 780 #
Proposal for a regulation Annex I – point f – point viii (viii) Actions to support investigation, risk assessment and risk management work on the link between animal health, wildlife trade, environmental factors, and human diseases, including during health crises, also through the development of ambitious EU coordinated actions to improve animal welfare.
Amendment 781 #
Proposal for a regulation Annex I – point f – point viii (viii) Actions to support investigation, risk assessment and risk management work on the link between animal health, animal welfare, wildlife trade, pet trade, intensive farming, environmental factors, and human diseases, including during health crises.
Amendment 782 #
Proposal for a regulation Annex I – point f – point viii a (new) (viiia) Actions to support better crisis management for critical medicines, including the creation, development of an EU central portal to monitoring shortages and an effective EU telematics infrastructure to make data on medicine and supply chain data interoperable via the full implementation of SPOR and connection to the FMD system;
Amendment 783 #
Proposal for a regulation Annex I – point f – point viii a (new) (viiia) The creation, development of an EU central portal to monitoring shortages and an effective EU telematics infrastructure to make data on medicine and supply chain data interoperable via the full implementation of SPOR and connection to the FMD system;
Amendment 784 #
Proposal for a regulation Annex I – point f – point viii a (new) (viii a) Support action regarding epidemiological surveillance, focusing on national health entities, thus contributing to assessment of factors that affect or determine the health of citizens;
Amendment 785 #
Proposal for a regulation Annex I – point f – point viii a (new) (viiia) Actions to secure continuity of undisrupted access to medicines, of care and treatment and in particular of chronic conditions during a health crisis;
Amendment 786 #
Proposal for a regulation Annex I – point f – point viii a (new) (viiia) Actions to secure continuity of care and treatment and in particular of chronic conditions during health crisis;
Amendment 787 #
Proposal for a regulation Annex I – point f – point viii a (new) (viiia) Actions to secure continuity of care and treatment and in particular of chronic conditions during health crisis;
Amendment 788 #
Proposal for a regulation Annex I – point f – point viii a (new) (viiia) Actions to secure continuity of care and treatment, in particular of chronic conditions during health crisis;
Amendment 789 #
Proposal for a regulation Annex I – point f – point viii b (new) (viiib) Support actions aimed at preventing the risks for individual and collective health that are associated with human organ trafficking and human trafficking for the purpose of organ procurement;
Amendment 790 #
Proposal for a regulation Annex I – point f – point viii b (new) (viiib) Actions to secure continuity of care and treatment and in particular of chronic conditions during health crisis;
Amendment 791 #
Proposal for a regulation Annex I – point f – point viii b (new) (viiib) Actions to secure continuity of care and treatment and in particular of chronic conditions during health crisis;
Amendment 792 #
Proposal for a regulation Annex I – point g – introductory part (g) Strengthen national health systems, promote and protect health and prevent diseases:
Amendment 793 #
Proposal for a regulation Annex I – point g – point i (i) Support knowledge transfer actions
Amendment 794 #
Proposal for a regulation Annex I – point g – point i (i) Support knowledge transfer actions and Union level cooperation to assist national reform processes towards improved effectiveness, accessibility, sustainability and resilience, while linking available EU funding, in particular to address the challenges identified by the European Semester and Country Specific Recommendations on health, and to strengthen primary care, reinforce the integration of care and aim at universal health coverage and equal access to healthcare;
Amendment 795 #
Proposal for a regulation Annex I – point g – point i (i) Support knowledge transfer actions, and Union level cooperation to assist national reform processes towards improved effectiveness, accessibility, sustainability and resilience, while linking available EU funding in particular to address the challenges identified by the European Semester and Country Specific Recommendations on health, and to strengthen primary care, reinforce the integration of care and
Amendment 796 #
Proposal for a regulation Annex I – point g – point i a (new) (ia) Support implementing policies, national programmes and guidelines to overcome inequalities in access to healthcare, including health equity assessments;
Amendment 797 #
Proposal for a regulation Annex I – point g – point ii (ii)
Amendment 798 #
Proposal for a regulation Annex I – point g – point ii (ii) Training programmes for medical and healthcare staff, including online programmes, and programmes for temporary exchanges of staff;
Amendment 799 #
Proposal for a regulation Annex I – point g – point ii (ii) Training and mobility programmes for medical and healthcare staff, and programmes for temporary exchanges of staff;
Amendment 800 #
Proposal for a regulation Annex I – point g – point ii (ii) Training programmes for medical and healthcare staff, and programmes for temporary exchanges of staff;
Amendment 801 #
Proposal for a regulation Annex I – point g – point iii (iii) Support
Amendment 802 #
Proposal for a regulation Annex I – point g – point iii (iii) Support to improve the geographical distribution of healthcare workforce and avoidance of ‘medical
Amendment 803 #
Proposal for a regulation Annex I – point g – point iii (iii) Support to improve the geographical distribution of healthcare workforce and avoidance of ‘medical deserts’, paying special attention to the EU’s outermost regions;
Amendment 804 #
Proposal for a regulation Annex I – point g – point iii (iii) Support to improve the geographical distribution of healthcare workforce and avoidance of ‘medical deserts’, i.e. areas with inadequate access to medical care and health services;
Amendment 805 #
Proposal for a regulation Annex I – point g – point iv (iv) Support the establishment and coordination and deployment of Union Reference Laboratories and Centres
Amendment 806 #
Proposal for a regulation Annex I – point g – point v (v) Audit of Member States preparedness and response arrangements (such as crisis management, antimicrobial resistance, vaccination), and implementation of health programmes that address health promotion and disease prevention and tackle communicable and non-communicable diseases;
Amendment 807 #
Proposal for a regulation Annex I – point g – point vi a (new) (via) Improve the current EU monitoring system to measure the extent of healthcare exclusion, collect data and report publicly on access barriers experienced by patients, and develop more accurate indicators where needed to capture these;
Amendment 808 #
Proposal for a regulation Annex I – point g – point vi a (new) (via) Improve the current EU monitoring system to measure the extent of healthcare exclusion, collect data and report publicly on access barriers experienced by patients, and develop more accurate indicators where needed to capture these;
Amendment 809 #
Proposal for a regulation Annex I – point g – point vi a (new) (via.) Support actions promoting mental health in the workplace and in schools; promote actions to combat depression and suicide; develop socially inclusive forms of mental health care;
Amendment 810 #
Proposal for a regulation Annex I – point g – point vi a (new) (via) Improve the current EU monitoring system to measure the extent of healthcare exclusion, including by developing adequate indicators, and collect data and report publicly on barriers experienced by patients;
Amendment 811 #
Proposal for a regulation Annex I – point g – point viii (viii) Support
Amendment 812 #
Proposal for a regulation Annex I – point g – point ix (ix) Support the establishment and implementation of programmes and in particular digital and evidence-based programmes assisting Member States and their action to improve health promotion, health literacy and disease prevention (for communicable and non-communicable diseases) in hospitals and communities;
Amendment 813 #
Proposal for a regulation Annex I – point g – point ix (ix) Support the establishment and implementation of programmes assisting Member States and their action to improve health promotion and disease prevention (for communicable and non-communicable diseases), including by reducing the burden of diseases caused or impacted by modifiable environmental factors;
Amendment 814 #
Proposal for a regulation Annex I – point g – point ix (ix) Support the establishment and implementation of
Amendment 815 #
Proposal for a regulation Annex I – point g – point ix (ix) Support the establishment and implementation of programmes and in particular digital programmes assisting Member States and their action to improve health promotion and disease prevention (for communicable and non-communicable diseases) in hospitals and communities;
Amendment 816 #
Proposal for a regulation Annex I – point g – point ix (ix) Support the establishment and implementation of programmes and in particular digital programmes assisting Member States and their action to improve
Amendment 817 #
Proposal for a regulation Annex I – point g – point ix (ix) Support the establishment and implementation of programmes assisting Member States and their action to improve health promotion and disease prevention (for communicable and non-communicable diseases) and mitigate the main risk factors of chronic diseases;
Amendment 818 #
Proposal for a regulation Annex I – point g – point ix a (new) (ixa) Support the development and the implementation of the European Disease Prevention and Management Guidelines in the area of both communicable and noncommunicable diseases, such as cancer, paediatric cancer, cardiovascular diseases, neurodegenerative diseases, respiratory diseases and diabetes;
Amendment 819 #
Proposal for a regulation Annex I – point g – point ix a (new) (ixa.) Support the establishment and implementation of evidence-based programmes assisting Member States and their actions to improve health promotion, health literacy and disease prevention (for communicable and non-communicable diseases);
Amendment 820 #
Proposal for a regulation Annex I – point g – point ix a (new) (ixa) Support the development and the implementation of European disease management guidelines in the area of both communicable and non- communicable diseases, such as cancer, paediatric cancer, cardiovascular diseases, neurodegenerative diseases, respiratory diseases and diabetes, among others;
Amendment 821 #
Proposal for a regulation Annex I – point g – point x (x) Support Member States’ actions to put in place healthy and safe urban, work and school environments, to enable healthy life choices and promote healthy diets taking into account the needs of vulnerable groups. Reduce inequalities in health literacy of patients and citizens by including health literacy in European and national health strategies, e.g. including Europe’s Beating Cancer Plan and National Cancer Control Plans;
Amendment 822 #
Proposal for a regulation Annex I – point g – point x (x) Support Member States’ actions to put in place healthy and safe urban, work and school environments, to enable healthy life choices and promote the regular practice of physical activity and healthy diets taking into account the needs of vulnerable groups;
Amendment 823 #
Proposal for a regulation Annex I – point g – point xi (xi) Support the functioning of the European Reference Networks and the establishment and operation of new transnational networks set out in accordance with Union health legislation, such as upscaling ERNs and expanding to other chronic disease areas, and support Member States’ actions to coordinate the activities of these networks with the operation of national health systems;
Amendment 824 #
Proposal for a regulation Annex I – point g – point xi (xi) Support the functioning of the European Reference Networks and the establishment and operation of new transnational networks set out in accordance with Union health legislation, such as upscaling ERNs and expanding to other chronic disease areas, and support Member States’ actions to coordinate the activities of these networks with the operation of national health systems;
Amendment 825 #
Proposal for a regulation Annex I – point g – point xi a (new) (xia) Advance the integration of ERNs into national health systems, by supporting the organisation of national multi-stakeholder workshops on integration to stimulate local discussions, as well as the development and implementation of the set of policies, rules and procedures required to anchor the ERN system to the national level;
Amendment 826 #
Proposal for a regulation Annex I – point g – point xi a (new) (xia) Advance the integration of ERNs into national health systems, by supporting the organisation of national multi-stakeholder workshops on integration to stimulate local discussions, as well as the development and implementation of the set of policies, rules and procedures required to anchor the ERN system to the national level;
Amendment 827 #
Proposal for a regulation Annex I – point g – point xi a (new) (xia) Support the development and implementation of programmes assisting Member States to improve their generic and biosimilar use while guaranteeing the prescribing autonomy of the physician to increase healthcare system efficiency;
Amendment 828 #
Proposal for a regulation Annex I – point g – point xi a (new) (xi a) Support Member States in the revision of their rare disease national plans to enact the necessary financial and organisational arrangements to integrate effectively ERNs system into national health systems;
Amendment 829 #
Proposal for a regulation Annex I – point g – point xi a (new) (xia) Support the development and implementation of programmes assisting Member States to improve their generic and biosimilar use to increase healthcare system efficiency;
Amendment 830 #
Proposal for a regulation Annex I – point g – point xii a (new) (xiia) Support the development and implementation of programmes assisting Member States to improve their generic and biosimilar use to increase healthcare system efficiency;
Amendment 831 #
Proposal for a regulation Annex I – point g – point xiii a (new) (xiiia) Support cooperation and coordination between Member States for the creation of a European Network for Hospitals Excellence, improving the cross-border treatment for rare diseases and increasing access to treatment for all Union citizens;
Amendment 832 #
Proposal for a regulation Annex I – point g – point xiii a (new) (xiiia) Support the development and implementation of programmes assisting Member States to improve their generic and biosimilar use to increase healthcare system resilience and efficiency;
Amendment 833 #
Proposal for a regulation Annex I – point g – point xiii a (new) (xiiia) Support actions to combat all types of discrimination concerning patients and to ensure that there is equal access for all to health;
Amendment 834 #
Proposal for a regulation Annex I – point g – point xiii a (new) (xiiia.)Support the Member States in ensuring continuity of care and treatment, in particular for chronic conditions.
Amendment 835 #
Proposal for a regulation Annex I – point g – point xiii a (new) (xiiia.) Support for Member States to make the leap into precision medicine (genomic medicine and predictive medicine).
Amendment 836 #
Proposal for a regulation Annex I – point g – point xiii b (new) (xiiib) Support actions to adopt a common set of health determinants and methodologies, and support Member States to collect, analyse and report these data and improve the knowledge, and support Union actions to mitigate health inequalities and iniquities;
Amendment 837 #
Proposal for a regulation Annex I – point g – point xiii b (new) (xiiib) Support the measurement, collection and analysis of patient outcomes, including by expanding the scope of data collection in routine clinical practice in a way that is standardised across the EU;
Amendment 838 #
Proposal for a regulation Annex I – point g – point xiii c (new) (xiiic) Improve the current monitoring system of the Union to measure the extent of healthcare exclusion, collect data and report publicly on access barriers experienced by patients, and develop more accurate indicators where needed to capture these;
Amendment 839 #
Proposal for a regulation Annex I – point g – point xiii d (new) (xiiid) Support Member States’ actions to boost health education and health literacy, creating well-informed societies, enhancing healthier lifestyles;
Amendment 840 #
Proposal for a regulation Annex I – point g – point xiii e (new) (xiiie) Support the creation and promotion of a Union platform for reliable and updated health information, available in all official languages of the Union, with food, medicines, health, sports and data on other issues;
Amendment 841 #
Proposal for a regulation Annex I – point g – point xiii f (new) (xiiif) Support the development and implementation of guidelines on health promotion and disease prevention in different stages of a person's lifetime and needs; creating quality standards to focus on, inter alia, child health, maternal health, aging health, mental health and reproductive and sexual health;
Amendment 842 #
Proposal for a regulation Annex I – point g – point xiii g (new) (xiiig) Support action to reduce health inequalities and inequities and reduce the unmet needs of vulnerable people, people living with chronic diseases, disabilities or incapacities;
Amendment 843 #
Proposal for a regulation Annex I – point g – point xiii h (new) (xiiih) Support collaboration between different sectors to improve health determinants and enhance the benefits in health outcomes;
Amendment 844 #
Proposal for a regulation Annex I – point g – point xiii i (new) (xiiii) Support the establishment of quality assurance schemes for disease- specific centres;
Amendment 845 #
Proposal for a regulation Annex I – point g – point xiii j (new) (xiiij) Actions supporting the quality of life of chronic disease patients, care givers and informal carers;
Amendment 846 #
Proposal for a regulation Annex I – point g – point xiii k (new) (xiiik) Actions supporting continuity of care (integrated care approaches for prevention, diagnosis, treatment and follow-up care);
Amendment 847 #
Proposal for a regulation Annex I – point h – introductory part (h) Actions on cancer and other major chronic diseases:
Amendment 848 #
Proposal for a regulation Annex I – point h – introductory part (h) Actions on
Amendment 849 #
Proposal for a regulation Annex I – point h – introductory part (h) Actions on
Amendment 850 #
Proposal for a regulation Annex I – point h – point i (i) Support Member States and NGOs in the promotion and implementation of the recommendations of the European Code against Cancer, as well as WHO recommendations on the prevention and control of chronic diseases;
Amendment 851 #
Proposal for a regulation Annex I – point h – point i (i) Support Member States and NGOs in the promotion and implementation of the recommendations of the European Code against Cancer, as well as WHO recommendations on the prevention and control of chronic diseases;
Amendment 852 #
Proposal for a regulation Annex I – point h – point i (i) Support Member States, the IARC and NGOs in the promotion and implementation of the recommendations of the European Code against Cancer;
Amendment 853 #
Proposal for a regulation Annex I – point h – point i (i) Support Member States and NGOs in the promotion and implementation of the recommendations of the European Code against Cancer as well as WHO recommendations on preventing and controlling chronic diseases;
Amendment 854 #
Proposal for a regulation Annex I – point h – point i (i) Support Member States, IARC and NGOs in the promotion and implementation of the recommendations of the European Code against Cancer;
Amendment 855 #
Proposal for a regulation Annex I – point h – point i a (new) (ia) Support the establishment of a European Cancer Institute (ECI) which would provide a platform for the implementation of the best standards of practices through European Reference Cancer Networks, the collection of clinical data among centres from all participating countries across Europe and beyond and the prioritisation of academic and clinical research programmes of excellence. The programme could support the development of national cancer registries in all Member States which are essential with a view to providing comparable data on cancer;
Amendment 856 #
Proposal for a regulation Annex I – point h – point i a (new) (ia) Support the revision and continuous update of the current edition of the European Code against Cancer accompanied by a systematic evaluation of the impact of the European Code against Cancer;
Amendment 857 #
Proposal for a regulation Annex I – point h – point i a (new) (ia) Support the revision and continuous update of the current edition of the European Code against Cancer accompanied by a systematic evaluation of the impact of the European Code against Cancer;
Amendment 858 #
Proposal for a regulation Annex I – point h – point ii (ii) Support the establishment of quality assurance schemes for cancer centres and other disease-specific centres;
Amendment 859 #
Proposal for a regulation Annex I – point h – point ii (ii) Support the establishment of quality assurance schemes for cancer centres and for other disease specific centres;
Amendment 860 #
Proposal for a regulation Annex I – point h – point ii (ii) Support the establishment of quality assurance schemes for cancer centres and other disease-specific centres;
Amendment 861 #
Proposal for a regulation Annex I – point h – point iii (iii) Support prevention programmes on the main
Amendment 862 #
Proposal for a regulation Annex I – point h – point iii (iii) Support prevention programmes on the main
Amendment 863 #
Proposal for a regulation Annex I – point h – point iii (iii) Support prevention programmes on the main
Amendment 864 #
Proposal for a regulation Annex I – point h – point iii (iii) Support prevention programmes on the main cancer risk factors that are of demonstrated effectiveness and supported by established evidence;
Amendment 865 #
Proposal for a regulation Annex I – point h – point iii (iii) Support prevention programmes on the main cancer risk factors, including the environmental ones;
Amendment 866 #
Proposal for a regulation Annex I – point h – point iv (iv) Actions to support secondary prevention of c
Amendment 867 #
Proposal for a regulation Annex I – point h – point iv (iv) Actions to support secondary prevention of c
Amendment 868 #
Proposal for a regulation Annex I – point h – point iv (iv) Actions to support secondary prevention of cancer as well as chronic diseases, such as early detection and diagnosis through screening;
Amendment 869 #
Proposal for a regulation Annex I – point h – point iv a (new) (iva) Ensure the continuous monitoring and evaluation of Council Recommendation on cancer screening (2003) enabling links to the European Cancer Information System and European Network of Cancer Registries;
Amendment 870 #
Proposal for a regulation Annex I – point h – point iv a (new) (iva) Ensure the continuous monitoring and evaluation of Council Recommendation on cancer screening (2003) enabling links to the European Cancer Information System and European Network of Cancer Registries;
Amendment 871 #
Proposal for a regulation Annex I – point h – point iv a (new) (iva) Actions to ensure broad implementation of effective screening and vaccination programs and strengthening of infrastructure to achieve elimination of infection-related cancers;
Amendment 872 #
Proposal for a regulation Annex I – point h – point iv b (new) (ivb) Actions to support the implementation of the WHO Global Call for the Elimination of Cervical Cancer;
Amendment 873 #
Proposal for a regulation Annex I – point h – point iv b (new) (ivb) Actions to support the implementation of the WHO Global Call for the Elimination of Cervical Cancer;
Amendment 874 #
Proposal for a regulation Annex I – point h – point v (v) Actions supporting access to c
Amendment 875 #
Proposal for a regulation Annex I – point h – point v (v) Actions supporting access to c
Amendment 876 #
Proposal for a regulation Annex I – point h – point v (v) Actions supporting access to cancer services
Amendment 877 #
Proposal for a regulation Annex I – point h – point v (v) Actions supporting access to cancer services and to innovative
Amendment 878 #
Proposal for a regulation Annex I – point h – point v (v) Actions supporting access to cancer services and to innovative, cost-effective and supportive care medicines for cancer;
Amendment 879 #
Proposal for a regulation Annex I – point h – point v (v) Actions supporting access to cancer and chronic disease services and to innovative medicines for cancer and other major chronic diseases;
Amendment 880 #
Proposal for a regulation Annex I – point h – point v (v) Actions supporting access to cancer services and to innovative and cost- effective medicines for cancer;
Amendment 881 #
Proposal for a regulation Annex I – point h – point v (v) Actions supporting access to cancer services and to innovative medicines for cancer, including actions to improve the affordability of oncology medications and treatments;
Amendment 882 #
Proposal for a regulation Annex I – point h – point v a (new) (va) Support implementing policies, national programmes and guidelines to overcome inequalities in access to essential therapies and medicines, supportive and palliative care of paediatric cancers across Europe, including availability and affordability of such healthcare and service;
Amendment 883 #
Proposal for a regulation Annex I – point h – point v a (new) (va) Actions supporting access to the effective European standard of cancer treatment and care across all Member States;
Amendment 884 #
Proposal for a regulation Annex I – point h – point v a (new) (va) Actions supporting access to the standard of cancer screening, treatment and care;
Amendment 885 #
Proposal for a regulation Annex I – point h – point v a (new) (va) Support equal and timely access to truly innovative medicines and therapies;
Amendment 886 #
Proposal for a regulation Annex I – point h – point v a (new) (va) Actions supporting access to the standard of cancer treatment and care;
Amendment 887 #
Proposal for a regulation Annex I – point h – point v a (new) (va) Actions supporting access to the standard of cancer treatment and care;
Amendment 888 #
Proposal for a regulation Annex I – point h – point v b (new) (vb) Support implementing policies, national programmes and guidelines regarding reducing inequalities in access to essential therapies and medicines, supportive and palliative care of paediatric cancers across Europe, including availability and affordability of such health care and services;
Amendment 889 #
Proposal for a regulation Annex I – point h – point v b (new) (vb) Support implementing policies, national programmes and guidelines to overcome inequalities in access to essential therapies and medicines, supportive and palliative care of paediatric cancers across Europe in full synergy with Horizon Europe and its missions and partnerships;
Amendment 890 #
Proposal for a regulation Annex I – point h – point v b (new) (vb) Actions supporting quality in cancer prevention and care including diagnosis and treatment;
Amendment 891 #
Proposal for a regulation Annex I – point h – point v c (new) (vc) Actions to promote health and safety for healthcare workers involved in cancer treatment;
Amendment 892 #
Proposal for a regulation Annex I – point h – point vi (vi) Actions supporting the continuity of care (integrated care approaches for prevention, diagnosis, treatment and follow
Amendment 893 #
Proposal for a regulation Annex I – point h – point vi a (new) (via) Support the establishment of a Cancer Dashboard to reduce systemic health inequalities and improve patient access to cancer care, with a focus on prevention, screening, early diagnosis, access to cancer diagnosis and treatment;
Amendment 894 #
Proposal for a regulation Annex I – point h – point vii (vii) Actions supporting quality in
Amendment 895 #
Proposal for a regulation Annex I – point h – point viii (viii) Actions supporting the quality of life of c
Amendment 896 #
Proposal for a regulation Annex I – point h – point vii (vii) Actions supporting quality in cancer prevention
Amendment 897 #
Proposal for a regulation Annex I – point h – point vii (vii) Actions supporting quality in c
Amendment 898 #
Proposal for a regulation Annex I – point h – point vii (vii) Actions supporting quality in c
Amendment 899 #
Proposal for a regulation Annex I – point h – point vii (vii) Actions supporting quality in cancer prevention and care including vaccination, diagnosis and treatment;
Amendment 900 #
Proposal for a regulation Annex I – point h – point viii (viii) Actions supporting the quality of life of cancer survivors and of chronic disease patients and care givers;
Amendment 901 #
Proposal for a regulation Annex I – point h – point viii (viii) Actions supporting the quality of life of cancer survivors, chronic disease patients and care givers;
Amendment 902 #
Proposal for a regulation Annex I – point h – point ix (ix) Support to the implementation, monitoring and enforcement of the Union’s tobacco control policy and legislation, and other related legislation in the area of prevention in line with the obligations in the WHO Framework Convention on Tobacco Control;
Amendment 903 #
Proposal for a regulation Annex I – point h – point ix (ix) Support to the implementation of the Union’s tobacco control policy and
Amendment 904 #
Proposal for a regulation Annex I – point h – point ix a (new) (ixa) Actions to support a coordinated and integrative, multi-disciplinary and patient-centred approach regarding chronic disease patients, in particular in the area of paediatric cancer;
Amendment 905 #
Proposal for a regulation Annex I – point h – point ix a (new) (ixa) Support actions in the area of reducing and preventing alcohol abuse in the perspective of a revised EU alcohol strategy;
Amendment 906 #
Proposal for a regulation Annex I – point h – point x (x) Establishment and support of a mechanisms for cross-specialty capacity building and continuous education in the area of c
Amendment 907 #
Proposal for a regulation Annex I – point h – point x (x) Establishment and support of a mechanisms for cross-specialty capacity building and continuous education in the area of c
Amendment 908 #
Proposal for a regulation Annex I – point h – point x (x) Establishment and support of a mechanisms for cross-specialty capacity building and continuous education in the area of cancer and chronic disease care.
Amendment 909 #
Proposal for a regulation Annex I – point h – point x (x) Establishment and support of
Amendment 910 #
Proposal for a regulation Annex I – point h – point x a (new) (xa.) Support actions to tackle common, shared risk factors and synergies between cancer and other major non- communicable diseases, such as neurological disorders, and to render the European cancer plan a template for other major disease areas;
Amendment 911 #
Proposal for a regulation Annex I – point h – point x a (new) (xa) Actions to support addressing common shared risk factors and synergies that cancer has with other major non- communicable diseases such as neurological disorders, as well as making EU cancer plan a template for other major disease areas;
Amendment 912 #
Proposal for a regulation Annex I – point h – point x a (new) (x a) Actions to support addressing common shared risk factors and synergies that cancer has with other major non- communicable diseases such as neurological disorders, as well as making EU cancer plan a template for other major disease areas;
Amendment 913 #
Proposal for a regulation Annex I – point h – point x a (new) (xa.) Actions to support addressing common, shared risk factors and synergies that cancer has with other major non-communicable diseases, such as neurological disorders.
Amendment 914 #
Proposal for a regulation Annex I – point h – point x a (new) (xa) Promote use of MEAT criteria in procurement mechanisms to enhance safe and timely usage of generic and biosimilar medicines in cancer care;
Amendment 915 #
Proposal for a regulation Annex I – point h – point x a (new) (xa) Promote use of MEAT criteria in procurement mechanisms to enhance safe and timely usage of generic and biosimilar medicines in cancer care;
Amendment 916 #
Proposal for a regulation Annex I – point h – point x a (new) (xa) actions to promote health and safety for healthcare workers involved in cancer treatment;
Amendment 917 #
Proposal for a regulation Annex I – point h – point x a (new) (xa) Establishment and support of a competence network on integrative treatment;
Amendment 918 #
Proposal for a regulation Annex I – point h – point x b (new) (xb) Building on Europe’s cancer plan, support the creation of a template for other major disease areas, such as neurological disorders;
Amendment 919 #
Proposal for a regulation Annex I – point h – point x b (new) (xb) Promote use of MEAT criteria in procurement mechanisms to enhance safe and timely usage of generic and biosimilar medicines in cancer care;
Amendment 920 #
Proposal for a regulation Annex I – point h – point x b (new) (xb) Building on the EU cancer plan, support the establishment of a template for other major diseases areas such as neurological disorders;
Amendment 921 #
Proposal for a regulation Annex I – point h – point x b (new) (xb) Support to Member States in setting up and implementing up-to-date National Cancer Plans in line with the EU Beating Cancer plan;
Amendment 922 #
Proposal for a regulation Annex I – point h – point x b (new) (xb) actions to promote health and safety for healthcare workers involved in cancer treatment;
Amendment 923 #
Proposal for a regulation Annex I – point h – point x b (new) (xb) actions to promote health and safety for healthcare workers involved in cancer treatment;
Amendment 924 #
Proposal for a regulation Annex I – point h – point x c (new) (xc) actions to promote health and safety for healthcare workers involved in cancer treatment;
Amendment 925 #
Proposal for a regulation Annex I – point i – introductory part (i) Actions on medicines, vaccines and medical devices: (i) Support to initiatives to improve vaccination coverage rates in the Member States; support initiatives to ensure that vaccine coverage is extended beyond early childhood and that all population groups can be included in a lifelong vaccination approach; (ia) Ensure high vaccination coverage rates to achieve herd immunity to protect vulnerable members of the society who cannot be vaccinated due to medical reasons; (iib) Support building and sustaining resilient immunisation system to maintain high vaccine uptake; (iic) Make access to vaccination convenient – integrating vaccination into non-health care settings such as workplace and schools to encourage vaccination through all stages in life; Support a clear framework for expanding vaccine delivery and information to all relevant health care professionals, incl. nurses and pharmacists; (iid) Establish Electronic Immunisation Records, as set out in the Council;
Amendment 926 #
Proposal for a regulation Annex I – point i – point ii (ii) Support actions to fight vaccine hesitancy; (ii a) Support tools and platforms to collect real-world evidence on the safety, effectiveness and impact of vaccines after use to fight vaccine hesitancy (iib) Develop appropriate metrics to track programme progress, including changes in the legislative environment and attitudes toward vaccination requirements. (iic) Strengthen healthcare training and provide a continuous medical training for all health workers. Healthcare workers play an essential role in rebuilding population’s confidence in vaccination. (iid) Support Member States in developing social media and awareness programmes to promote the public health impact of vaccination and present a clear and balanced explanations of any potential risks and benefits to individuals;
Amendment 927 #
Proposal for a regulation Annex I – point i – point ii (ii) Support actions to fight vaccine hesitancy through ongoing community engagement, addressing of individual and group concerns, trust-building activities;
Amendment 928 #
Proposal for a regulation Annex I – point i – point ii (ii) Support actions to fight vaccine hesitancy and disinformation;
Amendment 929 #
Proposal for a regulation Annex I – point i – point ii a (new) (iia) Support tools and platforms to collect real-world data to produce real- world evidence, promote research and evidence on the safety, effectiveness and impact of vaccines, while guaranteeing robust evidence generation in the pre- approval phase;
Amendment 930 #
Proposal for a regulation Annex I – point i – point ii a (new) (iia) Support tools and platforms to collect real-world anonymised data on the quality, safety and efficacy of vaccines in use, without prejudice to the generation of robust evidence in the pre-approval phase;
Amendment 931 #
Proposal for a regulation Annex I – point i – point ii a (new) (iia) Support actions to promote the use of generic and biosimilar medicines;
Amendment 932 #
Proposal for a regulation Annex I – point i – point ii a (new) (iia) Establish of a EU vaccination card;
Amendment 933 #
Proposal for a regulation Annex I – point i – point iii (iii) Support clinical trials, including those involving increased coordination at Union level and with EMA, to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines; support publication of all clinical reports (including CSRs) on the day marketing authorisation is granted for such medicines and vaccines;
Amendment 934 #
Proposal for a regulation Annex I – point i – point iii (iii) Support clinical trials, including those involving collaboration between Member States, increased coordination at Union level and with the European Medicines Agency, to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines;
Amendment 935 #
Proposal for a regulation Annex I – point i – point iii (iii) Support clinical trials, in particular support to their transparency and to the full implementation of the EU database with publicly accessible data, to speed up the development, authorisation and access to innovative, safe and effective medicines
Amendment 936 #
Proposal for a regulation Annex I – point i – point iii (iii) Support clinical trials to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines; support publication of all clinical reports (including CSRs) on the day of marketing authorisation;
Amendment 937 #
Proposal for a regulation Annex I – point i – point iii (iii) Support clinical trials to speed up the development, authorisation and equitable access to innovative, affordable safe and effective medicines and vaccines, including timely public access to clinical study reports;
Amendment 938 #
Proposal for a regulation Annex I – point i – point iii (iii) Support clinical trials and the use of real world data to speed up the development, authorisation and a pan EU access to innovative, safe and effective medicines and vaccines;
Amendment 939 #
Proposal for a regulation Annex I – point i – point iii a (new) (iiia) Support action to ensure greater availability in the Union of medicines and medical devices and contribute to their affordability for patients and health systems;
Amendment 940 #
Proposal for a regulation Annex I – point i – point iii a (new) (iiia) support action for traceability rules on medicines both with regard to the final product and its components;
Amendment 941 #
Proposal for a regulation Annex I – point i – point iv (iv) Support action to ensure greater availability and affordability in the Union of medicines, vaccines, and medical devices and contribute to their affordability for patients and health systems, using the Union mechanism as joint procurement at the same time enhance the transparency of the process;
Amendment 942 #
Proposal for a regulation Annex I – point i – point iv a (new) (iva) Support action to modify the regulatory framework in the Union, to foster public health driven research and innovation and to encourage the discovery and development, production and fair distribution of innovative quality and affordable medicines, treatments, devices and vaccines for unmet medical needs in a transparent manner;
Amendment 943 #
Proposal for a regulation Annex I – point i – point iv a (new) (iva) Support action to strengthen the regulatory framework in the Union to encourage the discovery and development of medicines and vaccines to meet the patient and public health needs and guaranteed the efficacy and safety of newly approved products;
Amendment 944 #
Proposal for a regulation Annex I – point i – point iv a (new) (iva) Foster a supportive environment for meaningful patient and public involvement in clinical trials, starting with the design phase and ending with dissemination;
Amendment 945 #
Proposal for a regulation Annex I – point i – point iv a (new) (iva) Foster a supportive environment for meaningful patient and public involvement in clinical trials, starting with the design phase and ending with dissemination;
Amendment 946 #
Proposal for a regulation Annex I – point i – point iv b (new) (ivb) Support the assessment of the impact of intellectual property incentives on biomedical innovation in general and to explore credible and effective alternatives to exclusive protections for the financing of medical R&D, such as the numerous tools based on delinkage mechanisms;
Amendment 947 #
Proposal for a regulation Annex I – point i – point iv c (new) (ivc) Support action for implementing an EU wide list of approved medicines, indicating which products are interchangeable and key information on their composition, description, prescription requirements and administration;
Amendment 948 #
Proposal for a regulation Annex I – point i – point iv d (new) (ivd) Support action to enable information-sharing among Member States on medicines prices, including discounts and rebates, and on their pricing and reimbursement policies;
Amendment 949 #
Proposal for a regulation Annex I – point i – point v (v) Support action to encourage the
Amendment 950 #
Proposal for a regulation Annex I – point i – point v (v) Support action that builds on EU achievements including the launch of the New Drugs for Bad Bugs (ND4BB) programme and the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR), to encourage the development of innovative products and of less commercially interesting products such as antimicrobials;
Amendment 951 #
Proposal for a regulation Annex I – point i – point v a (new) (va) Support actions to implement models of R&D and IP ownership and management which prioritise the public interest and ensure that there are societal benefits, for example by including binding safeguards to ensure availability, accessibility and affordability of medical products developed with public funds;
Amendment 952 #
Proposal for a regulation Annex I – point i – point v a (new) (v a) Support actions to implement models of R&D and IP ownership and management which prioritize the public interest and guarantee societal benefit, for example by including binding safeguards to ensure availability, accessibility and affordability of medical products developed with public funds;
Amendment 953 #
Proposal for a regulation Annex I – point i – point v a (new) (va) Support actions to foster innovation on in repurposing, reformulation and combinations of off- patent medicines that that deliver relevant improvements for patients, healthcare professionals and/or healthcare systems;
Amendment 954 #
Proposal for a regulation Annex I – point i – point v a (new) (va) Support actions to foster innovation on in repurposing, reformulation and combinations of off- patent medicines that that deliver relevant improvements for patients, healthcare professionals and/or healthcare systems;
Amendment 955 #
Proposal for a regulation Annex I – point i – point v a (new) (va) Support actions to foster innovation in repurposing, reformulation and combinations of off-patent medicines that that deliver relevant improvements for patients, healthcare professionals and/or healthcare systems;
Amendment 956 #
Proposal for a regulation Annex I – point i – point v a (new) (va.) Create favourable conditions for significant patient and social engagement with clinical research;
Amendment 957 #
Proposal for a regulation Annex I – point i – point v b (new) (vb) Action to sustain a strong intellectual property framework, incentives and reward mechanisms for R&D, in order to attract investments in the Union for the development of the next generation of medicines, vaccines and medical devices;
Amendment 958 #
Proposal for a regulation Annex I – point i – point v c (new) (vc) Action to sustain a strong, balanced and adequate intellectual property framework, incentives and reward mechanisms for R&D, in order to attract investments in the Union for the development, manufacturing and distribution of the next generation of medicines, vaccines and medical devices, including personalised medicine;
Amendment 959 #
Proposal for a regulation Annex I – point i – point vi (vi) Support action to monitor, prevent, manage, report and notify shortages of medicines and medical devices occurring in hospitals and community pharmacies, to collect reported shortages in a centralized database, interoperable with databases that contained regulatory data on medicines, to address such shortages, and to increase security of supplies;
Amendment 960 #
Proposal for a regulation Annex I – point i – point vi (vi) Support action to monitor, report and notify shortages of medicines and medical devices occurring in hospitals and community pharmacies, to compile the identified shortages in a centralised database that is interoperable with the drug regulatory databases, to address such shortages, and to increase security of supplies;
Amendment 961 #
Proposal for a regulation Annex I – point i – point vi (vi) Support action to monitor, report and notify shortages of medicines and medical devices occurring in hospitals and community pharmacies, to collect reported shortages in a centralized database, interoperable with databases that contained regulatory data on medicines, to address such shortages, and to increase security of supplies;
Amendment 962 #
Proposal for a regulation Annex I – point i – point vi (vi) Support action to monitor shortages of medicines and medical devices occurring in hospitals and community pharmacies, to address such shortages at their roots, and to increase security of supplies;
Amendment 963 #
Proposal for a regulation Annex I – point i – point vii (vii) Support actions to encourage the development of innovative medicines and medical devices less harmful for the environment and promote greener manufacturing and reward investments in procurement processes;
Amendment 964 #
Proposal for a regulation Annex I – point i – point vii (vii) Support actions to encourage the
Amendment 965 #
Proposal for a regulation Annex I – point i – point vii (vii) Support actions to encourage the development of
Amendment 966 #
Proposal for a regulation Annex I – point i – point vii a (new) (viia) Support actions for a sustainability assessment of applications of synthetic biology;
Amendment 967 #
Proposal for a regulation Annex I – point i – point viii (viii) Action to strengthen the environmental risk assessment of pharmaceuticals and to centrally collect and provide access to relevant stakeholders to all known environmental risk assessment data in a uniform way, avoiding unnecessary duplications; including the use of raw materials and impact of REACH on the supply chain using alternate production methods to circumvent processes eg enzymic and using reg flex to be able to commercialise as well as using alternate technology to deliver safer solutions whilst encouraged through purchasing incentives;
Amendment 968 #
Proposal for a regulation Annex I – point i – point viii (viii) Action to strengthen the environmental risk assessment of pollution factors, such as air, water and soil pollution, chemical exposures, climate change, ultraviolet radiation and pharmaceuticals;
Amendment 969 #
Proposal for a regulation Annex I – point i – point viii (viii) Action to strengthen the environmental risk assessment of pharmaceuticals and to reward such investments in contract award procedures;
Amendment 970 #
Proposal for a regulation Annex I – point i – point viii (viii) Action to strengthen the environmental risk assessment of pharmaceuticals and medical devices;
Amendment 971 #
Proposal for a regulation Annex I – point i – point ix (ix) Action to promote the prudent use and disposal of
Amendment 972 #
Proposal for a regulation Annex I – point i – point ix (ix) Action to promote the prudent use and disposal of
Amendment 973 #
Proposal for a regulation Annex I – point i – point ix (ix) Action to promote the prudent use and disposal of
Amendment 974 #
Proposal for a regulation Annex I – point i – point ix (ix) Action to promote the prudent use and disposal of antimicrobials, surveillance of antimicrobial use, antimicrobial resistance and support action to fight against AMR;
Amendment 975 #
Proposal for a regulation Annex I – point i – point ix (ix) Action to significantly reduce overall use of antimicrobials, to promote the prudent use and disposal of antimicrobials, and the use of non- antibiotic treatments;
Amendment 976 #
Proposal for a regulation Annex I – point i – point ix (ix) Action to promote the prudent use and disposal of antimicrobials, setting up traceable targets for reduction in antibiotics use;
Amendment 977 #
Proposal for a regulation Annex I – point i – point x (x) Support action to foster international development and regulatory convergence and reliance on medicines and medical devices
Amendment 978 #
Proposal for a regulation Annex I – point i – point x (x) Support action to foster international development and regulatory convergence and reliance on medicines and medical devices
Amendment 979 #
Proposal for a regulation Annex I – point i – point x (x) Support action to foster international regulatory convergence on medicines
Amendment 980 #
Proposal for a regulation Annex I – point i – point x (x) Support action to foster international regulatory convergence on medicines and medical devices.
Amendment 981 #
Proposal for a regulation Annex I – point i – point x a (new) (xa) Support action to establish joint procurement for medicines to treat rare diseases in order to ensure that these medicines are available in all Member States and at an equal price;
Amendment 982 #
Proposal for a regulation Annex I – point i – point x a (new) (xa) Support the creation of national tools to implement the health technology assessments (HTA);
Amendment 983 #
Proposal for a regulation Annex I – point i – point x b (new) (xb) action to promote data transparency in the entire value chain of medicines;
Amendment 984 #
Proposal for a regulation Annex I – point i – point x c (new) (xc) action to create scientific advisory systems at national and Union level that support SMEs, Start-ups and others in the health sector;
Amendment 985 #
Proposal for a regulation Annex I – point i – point x d (new) (xd) Support actions aimed at strengthening the fight against counterfeiting and piracy of medicines and medical devices;
Amendment 986 #
Proposal for a regulation Annex I – point i – point x e (new) (xe) Support actions to promote the reinforcement of investment in a joint R&D policy;
Amendment 987 #
Proposal for a regulation Annex I – point i – point x f (new) (xf) Support the strengthening of investment in instruments for monitoring the commerce and availability of medicines for human use and medical devices, at national and Union level;
Amendment 988 #
Proposal for a regulation Annex I – point i – point x g (new) (xg) Support research into possible repurposing of existing drugs, exploring new uses and indications of therapies for existing drugs;
Amendment 989 #
Proposal for a regulation Annex I – point j – point i (i) Support for the deployment, operation and maintenance of mature interoperable digital service infrastructures and data security and quality assurance processes for data exchange, access, use and reuse; support for cross border networking, including through
Amendment 990 #
Proposal for a regulation Annex I – point j – point i (i) Support for the deployment, operation and maintenance of mature interoperable digital service infrastructures and data security and quality assurance processes for data exchange, access, use and reuse; support for cross border networking, including through
Amendment 991 #
Proposal for a regulation Annex I – point j – point i (i) Support for the deployment, operation and maintenance of mature interoperable digital service infrastructures and data security and quality assurance processes for data exchange, access, use and reuse; support for cross border networking, including through
Amendment 992 #
Proposal for a regulation Annex I – point j – point i a (new) (ia) Actions to ensure that Electronic Health Records are designed for the support of clinical care and research and to support National health systems in ensuring the integration with the patient registries and the incorporation of EHR data into those registries;
Amendment 993 #
Proposal for a regulation Annex I – point j – point ii (ii) Support
Amendment 994 #
Proposal for a regulation Annex I – point j – point ii (ii) Support
Amendment 995 #
Proposal for a regulation Annex I – point j – point ii (ii) Support investments in to the digital transformation of health care and health systems, including through benchmarking and capacity building for the uptake of innovative tools and technologies; support investments in infrastructures, digital tools and methodologies to collect and analyse health data and real-world evidence; support digital upskilling of health
Amendment 996 #
Proposal for a regulation Annex I – point j – point ii (ii) Support
Amendment 997 #
Proposal for a regulation Annex I – point j – point ii (ii) Support
Amendment 998 #
Proposal for a regulation Annex I – point j – point iii (iii) Support the deployment and interoperability of digital tools and infrastructures within and between Member States and with Union Institutions, Agencies and bodies; including support for the implementation of an Electronic European Health Record; develop appropriate governance structures and sustainable, interoperable Union health information systems, as part of the European Health Data Space and
Amendment 999 #
Proposal for a regulation Annex I – point j – point iii (iii) Support the deployment and interoperability of digital tools and infrastructures within and between Member States and with Union Institutions, Agencies and bodies; including support for the implementation of an Electronic European Health Record; develop appropriate governance structures and sustainable, interoperable Union health information
source: 653.822
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| docs/3/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947&secondRef=02 |
| docs/4/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308&secondRef=01 |
| forecasts |
|
2021-02-23Show (1) Changes | Timetravel
| docs/4/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308&secondRef=01New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308 |
2021-02-17Show (2) Changes | Timetravel
| committees/0 |
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| committees/0 |
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2021-02-16Show (5) Changes | Timetravel
| committees/0 |
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| committees/0 |
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| committees/5/rapporteur/0/mepref |
197499
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| docs/4/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308&secondRef=01 |
| events/7 |
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2020-12-09Show (5) Changes | Timetravel
| commission |
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| committees/0 |
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| committees/0 |
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| committees/5/rapporteur/0/mepref |
197499
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| events/4/docs |
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2020-11-26Show (2) Changes | Timetravel
| docs/5 |
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| events/5/summary |
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2020-11-19Show (6) Changes | Timetravel
| docs/3/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947&secondRef=02New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947 |
| docs/5 |
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| events/4 |
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| events/5 |
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| events/6 |
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| forecasts |
|
2020-11-18Show (2) Changes | Timetravel
| procedure/Modified legal basis |
Rules of Procedure EP 159
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| procedure/Other legal basis |
Rules of Procedure EP 159
|
2020-11-07Show (3) Changes | Timetravel
| docs/4/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308&secondRef=01New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308 |
| forecasts/0 |
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| forecasts/0 |
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2020-11-06Show (2) Changes | Timetravel
| docs/3/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947&secondRef=02 |
| docs/4/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308&secondRef=01 |
2020-11-03Show (1) Changes | Timetravel
| docs/3/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947&secondRef=02New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947 |
2020-11-01Show (3) Changes | Timetravel
| docs/3/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947&secondRef=02 |
| events/3 |
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| events/3 |
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2020-10-20Show (2) Changes | Timetravel
| events/3 |
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| procedure/stage_reached |
Old
Awaiting committee decisionNew
Awaiting Parliament's position in 1st reading |
2020-10-15Show (2) Changes | Timetravel
| events/2 |
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| procedure/Modified legal basis |
Rules of Procedure EP 159
|
2020-10-14Show (1) Changes | Timetravel
| docs/4/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308&secondRef=01New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308 |
2020-10-09Show (2) Changes | Timetravel
| docs/3/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947&secondRef=02New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947 |
| forecasts |
|
2020-10-06Show (1) Changes | Timetravel
| docs/4/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308&secondRef=01 |
2020-09-27Show (2) Changes | Timetravel
| committees/0/shadows |
|
| docs/4/docs/0/url |
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE657.308
|
2020-09-14Show (1) Changes | Timetravel
| docs/4/date |
Old
2020-09-11T00:00:00New
2020-09-14T00:00:00 |
2020-09-11Show (2) Changes | Timetravel
| docs/3/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947&secondRef=02 |
| docs/4 |
|
2020-09-10Show (1) Changes | Timetravel
| docs/3/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947&secondRef=02New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947 |
2020-09-09Show (1) Changes | Timetravel
| docs/3/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947&secondRef=02 |
2020-09-04Show (1) Changes | Timetravel
| docs/3/docs/0/url |
Old
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947&secondRef=02New
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.947 |
2020-09-03Show (1) Changes | Timetravel
| docs/3 |
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2020-08-25Show (2) Changes | Timetravel
| committees/5/rapporteur |
|
| docs/4 |
|
2020-07-23Show (3) Changes | Timetravel
| committees/5 |
|
| docs/1/docs/0/url |
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.822
|
| docs/2/docs/0/url |
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE655.706
|
2020-07-17Show (2) Changes | Timetravel
| docs/1/date |
Old
2020-07-08T00:00:00New
2020-07-16T00:00:00 |
| docs/2 |
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2020-07-08Show (2) Changes | Timetravel
| docs/1 |
|
| docs/2 |
|
2020-07-01Show (1) Changes | Timetravel
| committees/2/opinion |
False
|
2020-06-30Show (1) Changes | Timetravel
| committees/3/opinion |
False
|
2020-06-25Show (1) Changes | Timetravel
| committees/4/opinion |
False
|
2020-06-24Show (4) Changes | Timetravel
| docs/0/docs/0/url |
https://www.europarl.europa.eu/sides/getDoc.do?type=COMPARL&mode=XML&language=EN&reference=PE653.803
|
| events/1 |
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| procedure/dossier_of_the_committee |
|
| procedure/stage_reached |
Old
Preparatory phase in ParliamentNew
Awaiting committee decision |
2020-06-23Show (1) Changes | Timetravel
| committees/2 |
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2020-06-19Show (1) Changes | Timetravel
| committees/1/rapporteur |
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2020-06-18Show (2) Changes | Timetravel
| docs/0 |
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| docs/0 |
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2020-06-17Show (1) Changes
| events/0/summary |
|