# C_2021415EN.01008601.xml

| 13.10.2021 | EN | Official Journal of the European Union | C 415/86 |
| --- | --- | --- | --- |

13.10.2021

EN

Official Journal of the European Union

C 415/86

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P9_TA(2020)0304

Programme for the Union's action in the field of health for the period 2021-2027 (‘EU4Health Programme’) ***I

Amendments adopted by the European Parliament on 13 November 2020 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’) (COM(2020)0405 — C9-0152/2020 — 2020/0102(COD)) (1)

(Ordinary legislative procedure: first reading)

(2021/C 415/17)

Amendment 1

Proposal for a regulation

Recital 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (1 a) | According to Article 8 of the Treaty on the Functioning of the European Union, in all its activities, the Union shall aim to eliminate inequalities, and to promote equality, between men and women, establishing the principle of gender mainstreaming. |

Text proposed by the Commission

Amendment

(1 a)

According to Article 8 of the Treaty on the Functioning of the European Union, in all its activities, the Union shall aim to eliminate inequalities, and to promote equality, between men and women, establishing the principle of gender mainstreaming.

Amendment 2

Proposal for a regulation

Recital 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| (2) | In accordance with Articles 9
  and
  168 of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union (the Charter), a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities. |

Text proposed by the Commission

Amendment

(2)

In accordance with Articles 9
  and
  168 of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union (the Charter), a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities.

| (2) | In accordance with Articles 9
  , 114,
  168
  and 191
  of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union (the Charter), a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities. |
| --- | --- |

(2)

In accordance with Articles 9
  , 114,
  168
  and 191
  of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union (the Charter), a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities.

Amendment 3

Proposal for a regulation

Recital 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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
  the
  Member
  States for the definition of
  their health
  policies and the organisation and delivery of
  health services and medical care. |

Text proposed by the Commission

Amendment

(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
  the
  Member
  States for the definition of
  their health
  policies and the organisation and delivery of
  health services and medical care.

| (3) | Article168 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
  each
  Member
  State to define
  their
  own
  health
  policy and to organise, deliver and manage
  health services and medical care. |
| --- | --- |

(3)

Article168 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
  each
  Member
  State to define
  their
  own
  health
  policy and to organise, deliver and manage
  health services and medical care.

Amendment 4

Proposal for a regulation

Recital 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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. |

Text proposed by the Commission

Amendment

(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.

| (5) | On 11 March 2020 the World Health Organization (WHO)
  , due to an exponential increase of cases,
  declared
  COVID-19 (the disease resulting from
  the novel coronavirus
  SARS-CoV
  -
  2
  )
  , and associated respiratory disease
  outbreak a global pandemic.
  The COVID-19
  pandemic
  and more specifically the moderate to severe cases of the disease that need intermediate and intensive medical care pushed several health systems to breaking point within and outside of the Union, and
  caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering
  , particularly affecting people with chronic conditions, causing both premature death and chronic conditions, and hitting the most vulnerable, patients, women, children, carers and the elderly the hardest
  .
  The severity of the crisis demonstrates also the importance of Union action and of adequately responding to threats deriving from infectious diseases, and in general of strengthening the Union's actions to complement national policies in the field of public health. |
| --- | --- |

(5)

On 11 March 2020 the World Health Organization (WHO)
  , due to an exponential increase of cases,
  declared
  COVID-19 (the disease resulting from
  the novel coronavirus
  SARS-CoV
  -
  2
  )
  , and associated respiratory disease
  outbreak a global pandemic.
  The COVID-19
  pandemic
  and more specifically the moderate to severe cases of the disease that need intermediate and intensive medical care pushed several health systems to breaking point within and outside of the Union, and
  caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering
  , particularly affecting people with chronic conditions, causing both premature death and chronic conditions, and hitting the most vulnerable, patients, women, children, carers and the elderly the hardest
  .
  The severity of the crisis demonstrates also the importance of Union action and of adequately responding to threats deriving from infectious diseases, and in general of strengthening the Union's actions to complement national policies in the field of public health.

Amendment 5

Proposal for a regulation

Recital 5 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (5 a) | Health care workers, which have been essential during the COVID-19 crisis, are predominantly women, and have been exposed to greater health risks during the crisis. |

Text proposed by the Commission

Amendment

(5 a)

Health care workers, which have been essential during the COVID-19 crisis, are predominantly women, and have been exposed to greater health risks during the crisis.

Amendment 6

Proposal for a regulation

Recital 5 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (5 b) | Taking into account that the effects of diseases can be different between men and women, as it seems clear with Covid 19, which has a higher mortality rate in men, the Programme should study the causes of diseases’ behaviour in order to advance as regards pathology, treatment and cures. |

Text proposed by the Commission

Amendment

(5 b)

Taking into account that the effects of diseases can be different between men and women, as it seems clear with Covid 19, which has a higher mortality rate in men, the Programme should study the causes of diseases’ behaviour in order to advance as regards pathology, treatment and cures.

Amendment 7

Proposal for a regulation

Recital 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| (6) | While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity (8). 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. |

Text proposed by the Commission

Amendment

(6)

While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity (8). 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.

| (6) | While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity (8). 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 particular between neighbouring border regions, as well as between authorities and relevant stakeholders. This cooperation should
  improve the
  preparedness,
  prevention and control of the spread of severe human
  infections and
  diseases across borders
  , to develop and make available products for the prevention and treatment of diseases
  , to combat other serious cross-border threats to health, and to safeguard
  and improve
  the health and well-being of
  all
  people in the Union.
  Preparedness is the key to improving resilience to future threats, and Member States, given their responsibility for the provision of healthcare, should carry out stress tests on their healthcare systems to identify weaknesses and verify that they are prepared for a possible future health crisis. |
| --- | --- |

(6)

While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity (8). 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 particular between neighbouring border regions, as well as between authorities and relevant stakeholders. This cooperation should
  improve the
  preparedness,
  prevention and control of the spread of severe human
  infections and
  diseases across borders
  , to develop and make available products for the prevention and treatment of diseases
  , to combat other serious cross-border threats to health, and to safeguard
  and improve
  the health and well-being of
  all
  people in the Union.
  Preparedness is the key to improving resilience to future threats, and Member States, given their responsibility for the provision of healthcare, should carry out stress tests on their healthcare systems to identify weaknesses and verify that they are prepared for a possible future health crisis.

Amendment 8

Proposal for a regulation

Recital 6 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (6 a) | While the Union's action in the field of health is limited, the Union should 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, environmental health and the health impacts of the climate change. The Union should support Member States in reducing health inequalities and in achieving universal health coverage, including provision of sexual and reproductive health services, addressing healthcare associated infections, addressing the challenges of vulnerable groups, such as children, infant and maternal care, an ageing population, of chronic diseases, and disease prevention, in promoting a healthy lifestyle, prevention services and preparing their health systems for emerging technologies in order to fully benefit from the digital revolution while seeking synergies with other relevant Union programmes such as Horizon Europe, Digital Europe, the Connecting Europe Facility programme or the Union’s Space Programme. |

Text proposed by the Commission

Amendment

(6 a)

While the Union's action in the field of health is limited, the Union should 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, environmental health and the health impacts of the climate change. The Union should support Member States in reducing health inequalities and in achieving universal health coverage, including provision of sexual and reproductive health services, addressing healthcare associated infections, addressing the challenges of vulnerable groups, such as children, infant and maternal care, an ageing population, of chronic diseases, and disease prevention, in promoting a healthy lifestyle, prevention services and preparing their health systems for emerging technologies in order to fully benefit from the digital revolution while seeking synergies with other relevant Union programmes such as Horizon Europe, Digital Europe, the Connecting Europe Facility programme or the Union’s Space Programme.

Amendment 9

Proposal for a regulation

Recital 7

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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. |

Text proposed by the Commission

Amendment

(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.

| (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
  at Union level as well as from cross-border
  cooperation at
  regional
  level and actions with an impact on the internal market.
  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. |
| --- | --- |

(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
  at Union level as well as from cross-border
  cooperation at
  regional
  level and actions with an impact on the internal market.
  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 10

Proposal for a regulation

Recital 10

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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 Council (10) 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. |

Text proposed by the Commission

Amendment

(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 Council (10) 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.

| (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 between neighbouring regions
  to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage
  any future
  health
  crises,
  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 (10) and other relevant mechanisms and structures established at Union level. This could include capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes
  , health information, and platforms to share best practices
  . 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’
  and ‘Health in all policies’ approaches
  . 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. |
| --- | --- |

(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 between neighbouring regions
  to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage
  any future
  health
  crises,
  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 (10) and other relevant mechanisms and structures established at Union level. This could include capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes
  , health information, and platforms to share best practices
  . 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’
  and ‘Health in all policies’ approaches
  . 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.

Amendment 11

Proposal for a regulation

Recital 11

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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 proposal (11) on Health Technology Assessment (HTA) to support cooperation on health technology assessment at Union level. |

Text proposed by the Commission

Amendment

(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 proposal (11) on Health Technology Assessment (HTA) to support cooperation on health technology assessment at Union level.

| (11) | In the
  context of public
  health
  crises,
  Health Technology Assessment
  (HTA) and
  clinical trials can contribute to the rapid development
  , identification and availability
  of medical countermeasures. The Commission has adopted a proposal (11) on Health Technology Assessment (HTA) to support cooperation on health technology assessment at Union level.
  The Programme should provide support to facilitate such actions. |
| --- | --- |

(11)

In the
  context of public
  health
  crises,
  Health Technology Assessment
  (HTA) and
  clinical trials can contribute to the rapid development
  , identification and availability
  of medical countermeasures. The Commission has adopted a proposal (11) on Health Technology Assessment (HTA) to support cooperation on health technology assessment at Union level.
  The Programme should provide support to facilitate such actions.

Amendment 12

Proposal for a regulation

Recital 12

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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. |

Text proposed by the Commission

Amendment

(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.

| (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
  , such as obesity, cancer, diabetes, cardiovascular disease and neurological disorders
  , 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, 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. |
| --- | --- |

(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
  , such as obesity, cancer, diabetes, cardiovascular disease and neurological disorders
  , 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, 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.

Amendment 13

Proposal for a regulation

Recital 13

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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 crisis relevant products ensuring complementarity with other Union instruments. |

Text proposed by the Commission

Amendment

(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 crisis relevant products ensuring complementarity with other Union instruments.

| (13) | The COVID-19 crisis has highlighted many challenges
  including the Union’s dependency on third countries
  in ensuring the supply of
  chemical raw and starting materials, active pharmaceutical ingredients,
  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
  will increase the security of production, procurement, management and distribution of medicinal products and medical devices in the Union and reduce dependency on third countries by encouraging the diversification of supply chains, fostering
  the production
  in the Union and joint
  procurement and management of crisis relevant products ensuring complementarity with other Union instruments
  , to mitigate the risk of shortages, especially in periods of health crises
  . |
| --- | --- |

(13)

The COVID-19 crisis has highlighted many challenges
  including the Union’s dependency on third countries
  in ensuring the supply of
  chemical raw and starting materials, active pharmaceutical ingredients,
  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
  will increase the security of production, procurement, management and distribution of medicinal products and medical devices in the Union and reduce dependency on third countries by encouraging the diversification of supply chains, fostering
  the production
  in the Union and joint
  procurement and management of crisis relevant products ensuring complementarity with other Union instruments
  , to mitigate the risk of shortages, especially in periods of health crises
  .

Amendment 14

Proposal for a regulation

Recital 14

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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. |

Text proposed by the Commission

Amendment

(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.

| (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
  also via an increased number of joint actions
  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
  . |
| --- | --- |

(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
  also via an increased number of joint actions
  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 15

Proposal for a regulation

Recital 14 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (14a) | 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 European Centre for Disease Control (‘ECDC’), strong immunization coverage at European level. |

Text proposed by the Commission

Amendment

(14a)

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 European Centre for Disease Control (‘ECDC’), strong immunization coverage at European level.

Amendment 16

Proposal for a regulation

Recital 15

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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 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 European Union Health Systems as set out in the Council Conclusions of 2 June 2006 (12) the Programme should support actions ensuring the universality and inclusivity of health care, meaning that no-one is barred access to health care, and those ensuring that patients’ rights,including on the privacy of their data, are duly respected. |

Text proposed by the Commission

Amendment

(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 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 European Union Health Systems as set out in the Council Conclusions of 2 June 2006 (12) the Programme should support actions ensuring the universality and inclusivity of health care, meaning that no-one is barred access to health care, and those ensuring that patients’ rights,including on the privacy of their data, are duly respected.

| (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, actions which advance digital transformation of health services and increase their interoperability, contribute to the increased capacity of health systems to foster
  primordial, primary, secondary, tertiary and quaternary
  disease prevention and health promotion, to provide new
  outcome-based
  care models and to deliver integrated services, from the community and primary health care to the highly specialised services, based on people's needs
  enhancing citizens’ levels of health literacy and digital health literacy,
  and ensure an efficient public health workforce equipped with the right skills, including digital skills
  , regularly updated in the light of scientific and technological progress, as provided for in Directive 2005/36/EC of the European Parliament and of the Council

   (11a)

  . The synergy between the European Health Programme and the Digital Europe Programme should contribute to the implementation and expansion of e-health, reducing unnecessary travel and unmet healthcare needs
  . 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
  accessibility, affordability,
  availability and quality of healthcare
  , increasing the amount of data available to patients and health workers, and thereby improving the quality of healthcare and the patient's freedom of movement around the Union
  . 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 European Union Health Systems as set out in the Council Conclusions of 2 June 2006 (12) the Programme should support actions ensuring the universality and inclusivity of health care, meaning that no-one is barred access to health care, and those ensuring that patients’ rights, including on the privacy of their data, are duly respected.
  The Programme should support access to and sharing of personal health data, without prejudice to the application of GDPR and increase the digital skills of patients. |
| --- | --- |

(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, actions which advance digital transformation of health services and increase their interoperability, contribute to the increased capacity of health systems to foster
  primordial, primary, secondary, tertiary and quaternary
  disease prevention and health promotion, to provide new
  outcome-based
  care models and to deliver integrated services, from the community and primary health care to the highly specialised services, based on people's needs
  enhancing citizens’ levels of health literacy and digital health literacy,
  and ensure an efficient public health workforce equipped with the right skills, including digital skills
  , regularly updated in the light of scientific and technological progress, as provided for in Directive 2005/36/EC of the European Parliament and of the Council

   (11a)

  . The synergy between the European Health Programme and the Digital Europe Programme should contribute to the implementation and expansion of e-health, reducing unnecessary travel and unmet healthcare needs
  . 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
  accessibility, affordability,
  availability and quality of healthcare
  , increasing the amount of data available to patients and health workers, and thereby improving the quality of healthcare and the patient's freedom of movement around the Union
  . 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 European Union Health Systems as set out in the Council Conclusions of 2 June 2006 (12) the Programme should support actions ensuring the universality and inclusivity of health care, meaning that no-one is barred access to health care, and those ensuring that patients’ rights, including on the privacy of their data, are duly respected.
  The Programme should support access to and sharing of personal health data, without prejudice to the application of GDPR and increase the digital skills of patients.

Amendment 17

Proposal for a regulation

Recital 15 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (15 a) | Gender and sex sensitivity and knowledge need 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. |

Text proposed by the Commission

Amendment

(15 a)

Gender and sex sensitivity and knowledge need 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 18

Proposal for a regulation

Recital 15 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (15 b) | 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. It is important to take account of the large amount of time that workers spend in their workplaces and the potential health risk they could be exposed to, such as health hazard substances and carcinogens and to repeated movements, leading to a high burden as regards 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. |

Text proposed by the Commission

Amendment

(15 b)

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. It is important to take account of the large amount of time that workers spend in their workplaces and the potential health risk they could be exposed to, such as health hazard substances and carcinogens and to repeated movements, leading to a high burden as regards 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 19

Proposal for a regulation

Recital 15 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (15c) | 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 regarding occupational safety and health. The Commission should propose a new Union strategic framework on occupational safety and health for the period 2021 — 2027 and continue updating Directive 2004/37/EC of the European Parliament and of the Council

   (12a)

  . 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. |

Text proposed by the Commission

Amendment

(15c)

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 regarding occupational safety and health. The Commission should propose a new Union strategic framework on occupational safety and health for the period 2021 — 2027 and continue updating Directive 2004/37/EC of the European Parliament and of the Council

   (12a)

  . 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 20

Proposal for a regulation

Recital 16

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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. 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. |

Text proposed by the Commission

Amendment

(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. 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.

| (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
  , by improving their health literacy,
  will have positive effects on health, health inequalities
  , health inequities
  , quality of life, productivity, competitiveness and inclusiveness, while reducing pressures on national
  health systems and
  budgets
  . The Programme should also support action to reduce inequalities in the provision of healthcare, in rural and remote areas including in the outermost regions, 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-being for all at all ages’ (13). The Programme therefore should contribute to the actions taken towards reaching
  the SDGs
  goals
  , and consequently improve the social determinants of health and enhance the health of the Union’s citizens
  . |
| --- | --- |

(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
  , by improving their health literacy,
  will have positive effects on health, health inequalities
  , health inequities
  , quality of life, productivity, competitiveness and inclusiveness, while reducing pressures on national
  health systems and
  budgets
  . The Programme should also support action to reduce inequalities in the provision of healthcare, in rural and remote areas including in the outermost regions, 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-being for all at all ages’ (13). The Programme therefore should contribute to the actions taken towards reaching
  the SDGs
  goals
  , and consequently improve the social determinants of health and enhance the health of the Union’s citizens
  .

Amendment 21

Proposal for a regulation

Recital 17

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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 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
  , combined with efforts to strengthen health systems. |

Text proposed by the Commission

Amendment

(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 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
  , combined with efforts to strengthen health systems.

| (17) | Non-communicable diseases are a result of a combination of genetic
  and health determinants (
  physiological,
  behavioural, and
  environmental) Such non-communicable diseases, as cardiovascular diseases, cancer,
  obesity,
  chronic respiratory diseases, diabetes,
  mental health illness and neurological disorders
  represent major causes of disability, ill-health, health-related retirement, and premature death in the Union,
  while non-communicable diseases were responsible for 87 % of Disability-Adjusted Life Years (DALYs) in the Union in 2017,
  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 Development Goals,
  particularly but not exclusively
  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
  health promotion and
  prevention across sectors
  , specialities and policy-fields, taking into account the interrelated nature of most non-communicable diseases
  , combined with efforts to strengthen health systems
  and the supply of appropriate medicines
  .
  , on strengthening the implementation of the WHO Framework Convention on Tobacco Control is crucial to achieving an effective, sustainable reduction in preventable non-communicable diseases. The Program should support actions aimed at integrating mental health into all areas, including in the workspace and in schools, and promote actions to combat depression and suicide and to implement integrative mental health care. |
| --- | --- |

(17)

Non-communicable diseases are a result of a combination of genetic
  and health determinants (
  physiological,
  behavioural, and
  environmental) Such non-communicable diseases, as cardiovascular diseases, cancer,
  obesity,
  chronic respiratory diseases, diabetes,
  mental health illness and neurological disorders
  represent major causes of disability, ill-health, health-related retirement, and premature death in the Union,
  while non-communicable diseases were responsible for 87 % of Disability-Adjusted Life Years (DALYs) in the Union in 2017,
  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 Development Goals,
  particularly but not exclusively
  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
  health promotion and
  prevention across sectors
  , specialities and policy-fields, taking into account the interrelated nature of most non-communicable diseases
  , combined with efforts to strengthen health systems
  and the supply of appropriate medicines
  .
  , on strengthening the implementation of the WHO Framework Convention on Tobacco Control is crucial to achieving an effective, sustainable reduction in preventable non-communicable diseases. The Program should support actions aimed at integrating mental health into all areas, including in the workspace and in schools, and promote actions to combat depression and suicide and to implement integrative mental health care.

Amendment 22

Proposal for a regulation

Recital 18

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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. The Programme should also
  therefore
  contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy. |

Text proposed by the Commission

Amendment

(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. The Programme should also
  therefore
  contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.

| (18) | Health promotion and health prevention are vastly more cost-efficient than treatment, both in terms of money and of quality-adjusted life years,
  therefore
  the Programme
  should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing
  determinants of
  health
  , such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, an unhealthy food environment, and the consumption of illicit drugs and psychoactive substances. To achieve the best health status possible, the Programme should tackle all health determinants. Health promotion, health protection and disease prevention throughout the lifetime of an individual should be at the core of the programme by addressing health and mental
  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 drugs
  and other addictive behaviours
  . The Programme should also contribute to the reduction of drugs-related health damage,
  obesity and
  unhealthy dietary habits, 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 therefore should contribute to a high level of human health protection and prevention, throughout the entire lifetime of an individual, including through the promotion of physical activity, nutritional care and promotion of health education. The Programme
  should also
  strengthen and support the implementation of the Union’s health-related legislation, including in the area of environmental health, and foster the ‘Health in All Policies’ approach.
  The Programme should also contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy
  and the Chemicals strategy for sustainability
  . |
| --- | --- |

(18)

Health promotion and health prevention are vastly more cost-efficient than treatment, both in terms of money and of quality-adjusted life years,
  therefore
  the Programme
  should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing
  determinants of
  health
  , such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, an unhealthy food environment, and the consumption of illicit drugs and psychoactive substances. To achieve the best health status possible, the Programme should tackle all health determinants. Health promotion, health protection and disease prevention throughout the lifetime of an individual should be at the core of the programme by addressing health and mental
  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 drugs
  and other addictive behaviours
  . The Programme should also contribute to the reduction of drugs-related health damage,
  obesity and
  unhealthy dietary habits, 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 therefore should contribute to a high level of human health protection and prevention, throughout the entire lifetime of an individual, including through the promotion of physical activity, nutritional care and promotion of health education. The Programme
  should also
  strengthen and support the implementation of the Union’s health-related legislation, including in the area of environmental health, and foster the ‘Health in All Policies’ approach.
  The Programme should also contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy
  and the Chemicals strategy for sustainability
  .

Amendment 23

Proposal for a regulation

Recital 18 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (18a) | The Programme should continue supporting actions in the area of reducing and preventing alcohol related harm in the perspective of a revised Union alcohol strategy. Protecting children from alcohol should be one of the Programme’s priorities. |

Text proposed by the Commission

Amendment

(18a)

The Programme should continue supporting actions in the area of reducing and preventing alcohol related harm in the perspective of a revised Union alcohol strategy. Protecting children from alcohol should be one of the Programme’s priorities.

Amendment 24

Proposal for a regulation

Recital 18 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (18 b) | 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 also placed an enormous burden on health systems. However, many chronic diseases, such as cardiovascular diseases and type 2 diabetes, could be prevented by healthy lifestyle choices, while other illnesses, for instance neurological diseases, can be managed to slow 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, and the Programme should support actions in this area. The Programme should support the development of specific European preventive and disease management guidelines in the area of both communicable and non-communicable diseases, such as cardiovascular diseases, neurodegenerative diseases, respiratory diseases and diabetes. |

Text proposed by the Commission

Amendment

(18 b)

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 also placed an enormous burden on health systems. However, many chronic diseases, such as cardiovascular diseases and type 2 diabetes, could be prevented by healthy lifestyle choices, while other illnesses, for instance neurological diseases, can be managed to slow 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, and the Programme should support actions in this area. The Programme should support the development of specific European preventive and disease management guidelines in the area of both communicable and non-communicable diseases, such as cardiovascular diseases, neurodegenerative diseases, respiratory diseases and diabetes.

Amendment 25

Proposal for a regulation

Recital 19

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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. |

Text proposed by the Commission

Amendment

(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.

| (19) | Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases.
  Cancer is caused by many factors 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, and therefore cancer prevention programmes should be implemented within the context of an integrated chronic disease prevention programme
  . In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover
  every key stage
  of the disease: prevention, diagnosis, treatment
  , life as a cancer survivor, reinsertion and palliative care and pain management. The programme should promote actions to complement the ‘Europe’s Beating Cancer Plan’ and thus improve cancer patients'
  quality of life. 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, and address cancer’s common risk factors and synergies with other major non-communicable diseases
  . |
| --- | --- |

(19)

Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases.
  Cancer is caused by many factors 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, and therefore cancer prevention programmes should be implemented within the context of an integrated chronic disease prevention programme
  . In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover
  every key stage
  of the disease: prevention, diagnosis, treatment
  , life as a cancer survivor, reinsertion and palliative care and pain management. The programme should promote actions to complement the ‘Europe’s Beating Cancer Plan’ and thus improve cancer patients'
  quality of life. 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, and address cancer’s common risk factors and synergies with other major non-communicable diseases
  .

Amendment 26

Proposal for a regulation

Recital 20

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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, 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+. |

Text proposed by the Commission

Amendment

(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, 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+.

| (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,
  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+. |
| --- | --- |

(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,
  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 249

Proposal for a regulation

Recital 20 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (20a) | The Programme should contribute to the establishment of a reserve of health crisis relevant products, such as essential medicines, vaccines and medical devices, in synergy and complementarity with rescEU, the Emergency Support Instrument, the Resilience Instrument and with other Union policies, programmes and funds. |

Text proposed by the Commission

Amendment

(20a)

The Programme should contribute to the establishment of a reserve of health crisis relevant products, such as essential medicines, vaccines and medical devices, in synergy and complementarity with rescEU, the Emergency Support Instrument, the Resilience Instrument and with other Union policies, programmes and funds.

Amendment 27

Proposal for a regulation

Recital 21

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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 high quality healthcare products and can fully benefit from them. |

Text proposed by the Commission

Amendment

(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 high quality healthcare products and can fully benefit from them.

| (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
  sustainable, efficient, equitable, affordable and
  high quality healthcare products
  , including in a cross-border context,
  and can fully benefit from them
  , based on transparent, consistent, patient-oriented medical information
  . |
| --- | --- |

(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
  sustainable, efficient, equitable, affordable and
  high quality healthcare products
  , including in a cross-border context,
  and can fully benefit from them
  , based on transparent, consistent, patient-oriented medical information
  .

Amendment 28

Proposal for a regulation

Recital 22

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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
  digitial
  transformation of healthcare products and platforms for monitoring and collecting information on medicines. |

Text proposed by the Commission

Amendment

(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
  digitial
  transformation of healthcare products and platforms for monitoring and collecting information on medicines.

| (22) | The Programme should support
  the development of a European monitoring, reporting and notification system for
  shortages of medicines, medical devices
  , vaccines, diagnostic tools,
  and other healthcare products
  , to avoid fragmentation of the single market
  and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries.
  The Programme should, therefore encourage the production of medicinal products and medical devices within the Union.
  In particular, in order to address unmet medical needs, the Programme should provide support to clinical
  and real world evidence generation to enable
  the development, authorisation
  , evaluation of
  and access to effective medicines
  , including generics and biosimilars, medical devices, and treatment, promote research and the development of new medicinal products, with particular attention to be given to antimicrobials and vaccines to tackle AMR and vaccine-preventable diseases
  , promote incentives to
  boost the production capacity for
  antimicrobials
  , personalized treatment and vaccination,
  and foster the
  digital
  transformation of healthcare products and platforms for monitoring and collecting information on medicines.
  The Programme should also strengthen decision-making on medicines by enabling access to and analysis of real-world healthcare data by regulators and health technology assessments (‘HTA’), bodies. The Programme should also help to ensure best use of research results and facilitate the uptake, scaling-up and deployment of health innovation in healthcare systems and clinical practice. |
| --- | --- |

(22)

The Programme should support
  the development of a European monitoring, reporting and notification system for
  shortages of medicines, medical devices
  , vaccines, diagnostic tools,
  and other healthcare products
  , to avoid fragmentation of the single market
  and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries.
  The Programme should, therefore encourage the production of medicinal products and medical devices within the Union.
  In particular, in order to address unmet medical needs, the Programme should provide support to clinical
  and real world evidence generation to enable
  the development, authorisation
  , evaluation of
  and access to effective medicines
  , including generics and biosimilars, medical devices, and treatment, promote research and the development of new medicinal products, with particular attention to be given to antimicrobials and vaccines to tackle AMR and vaccine-preventable diseases
  , promote incentives to
  boost the production capacity for
  antimicrobials
  , personalized treatment and vaccination,
  and foster the
  digital
  transformation of healthcare products and platforms for monitoring and collecting information on medicines.
  The Programme should also strengthen decision-making on medicines by enabling access to and analysis of real-world healthcare data by regulators and health technology assessments (‘HTA’), bodies. The Programme should also help to ensure best use of research results and facilitate the uptake, scaling-up and deployment of health innovation in healthcare systems and clinical practice.

Amendment 29

Proposal for a regulation

Recital 22 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (22 a) | A harmonised definition should be laid down at Union level for the terms ‘shortage’, ‘tension’, ‘supply disruptions’, ‘stock-out’ and ‘overstocking’. The Commission should work towards developing such harmonised definitions in close cooperation with the Member States and all the relevant stakeholders, including patient organisations. Moreover, the Commission should, in particular, reinforce the definition of ‘shortage’ proposed by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) joint Task Force in 2019. |

Text proposed by the Commission

Amendment

(22 a)

A harmonised definition should be laid down at Union level for the terms ‘shortage’, ‘tension’, ‘supply disruptions’, ‘stock-out’ and ‘overstocking’. The Commission should work towards developing such harmonised definitions in close cooperation with the Member States and all the relevant stakeholders, including patient organisations. Moreover, the Commission should, in particular, reinforce the definition of ‘shortage’ proposed by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) joint Task Force in 2019.

Amendment 30

Proposal for a regulation

Recital 23

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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 Resistance (14), 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. |

Text proposed by the Commission

Amendment

(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 Resistance (14), 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.

| (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 Resistance (14), adopted in June 2017 following the request from Member States, and given
  that
  infections
  and sepsis caused by antibiotic-resistant bacteria are responsible for a high number of deaths in the Union
  , it is essential that the Programme supports actions aimed at the prudent use of antimicrobials in humans, animals and crops,
  and actions including the use of non-antibiotic integrative treatments,
  in the framework of an integrated policy on patient safety and prevention of medical errors.
  The Programme should support the monitoring and surveillance programmes on the usage of antimicrobials and AMR, and the support to the implementation of local, regional and national plans to fight against AMR, supported by evidence-based strategies and the sharing of good practices within the Union. |
| --- | --- |

(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 Resistance (14), adopted in June 2017 following the request from Member States, and given
  that
  infections
  and sepsis caused by antibiotic-resistant bacteria are responsible for a high number of deaths in the Union
  , it is essential that the Programme supports actions aimed at the prudent use of antimicrobials in humans, animals and crops,
  and actions including the use of non-antibiotic integrative treatments,
  in the framework of an integrated policy on patient safety and prevention of medical errors.
  The Programme should support the monitoring and surveillance programmes on the usage of antimicrobials and AMR, and the support to the implementation of local, regional and national plans to fight against AMR, supported by evidence-based strategies and the sharing of good practices within the Union.

Amendment 31

Proposal for a regulation

Recital 24

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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 Environment (15). |

Text proposed by the Commission

Amendment

(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 Environment (15).

| (24) | Since
  the
  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 Environment (15). |
| --- | --- |

(24)

Since
  the
  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 Environment (15).

Amendment 32

Proposal for a regulation

Recital 25

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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, comparable and reliable data to underpin policymaking and monitoring. |

Text proposed by the Commission

Amendment

(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, comparable and reliable data to underpin policymaking and monitoring.

| (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 and enforcement of Union health legislation and
  , in conjunction with key partners such as EMA and ECDC,
  provide high quality
  , unbiased
  , comparable and reliable data
  , including real-world healthcare data collected locally across Europe, through a well-defined homogeneous methodology,
  to underpin policymaking and monitoring
  , set targets and develop tools to measure progress
  . |
| --- | --- |

(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 and enforcement of Union health legislation and
  , in conjunction with key partners such as EMA and ECDC,
  provide high quality
  , unbiased
  , comparable and reliable data
  , including real-world healthcare data collected locally across Europe, through a well-defined homogeneous methodology,
  to underpin policymaking and monitoring
  , set targets and develop tools to measure progress
  .

Amendment 33

Proposal for a regulation

Recital 26

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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. The Programme should therefore
  support activities to enable
  such integrated and coordinated work
  , which also serves
  to foster the implementation of high-impact practices that are aimed at distributing in the most effective way the available resources to the
  concerned
  population and areas so as to maximise their impact. |

Text proposed by the Commission

Amendment

(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. The Programme should therefore
  support activities to enable
  such integrated and coordinated work
  , which also serves
  to foster the implementation of high-impact practices that are aimed at distributing in the most effective way the available resources to the
  concerned
  population and areas so as to maximise their impact.

| (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
  be aimed at ensuring that
  such integrated and coordinated work
  is developed and implemented to its full potential in areas such as HTA and ERNs. That work would serve
  to foster the implementation of high-impact practices that are aimed at distributing in the most effective way the available resources to the
  relevant groups of the
  population and areas so as to maximise their impact. |
| --- | --- |

(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
  be aimed at ensuring that
  such integrated and coordinated work
  is developed and implemented to its full potential in areas such as HTA and ERNs. That work would serve
  to foster the implementation of high-impact practices that are aimed at distributing in the most effective way the available resources to the
  relevant groups of the
  population and areas so as to maximise their impact.

Amendment 34

Proposal for a regulation

Recital 26 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (26 a) | 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. In order to respond to public health threats, the Programme should under Article 168 TFEU support the creation of a European Health Response Mechanism, 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 should 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. |

Text proposed by the Commission

Amendment

(26 a)

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. In order to respond to public health threats, the Programme should under Article 168 TFEU support the creation of a European Health Response Mechanism, 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 should 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 35

Proposal for a regulation

Recital 27

| Text proposed by the Commission | Amendment |
| --- | --- |
| (27) | The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council (16) 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. |

Text proposed by the Commission

Amendment

(27)

The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council (16) 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.

| (27) | The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council (16) 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.
  ERNs are a ground-breaking platform that represents a unique opportunity and which, based on the innovative use and sharing of knowledge and health data across borders, aims to improve diagnosis and care for people living with a rare or complex disease. The Programme should, therefore, provide adequate funding to support the coordination and collaborative activities of both existing and future ERNs through grants or other instruments that are fit for purpose. It should increase upscale current funding to ensure that ERNs fulfil the objectives set out in their mission.
  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
  also
  contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider
  reinforcing ERNs, supporting the creation of new ERNs to cover infectious
  diseases
  , complex pregnancies and rare and complex mental health diseases. The reinforcement of ERNs can play a key role in supporting the adoption of a common newly developed screening framework at Union level, starting from disease selection criteria and mechanisms, with the aim of overcoming existing inequalities in terms of screening coverage across Member States. The Programme should also consider the development of excellence networks in the field of
  communicable and non-communicable diseases
  , including
  cancer
  and paediatric cancer, cardiovascular disease, chronic respiratory disease, diabetes, mental health conditions, neurodegenerative diseases and other major chronic diseases, and in the field of health crisis management
  . |
| --- | --- |

(27)

The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council (16) 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.
  ERNs are a ground-breaking platform that represents a unique opportunity and which, based on the innovative use and sharing of knowledge and health data across borders, aims to improve diagnosis and care for people living with a rare or complex disease. The Programme should, therefore, provide adequate funding to support the coordination and collaborative activities of both existing and future ERNs through grants or other instruments that are fit for purpose. It should increase upscale current funding to ensure that ERNs fulfil the objectives set out in their mission.
  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
  also
  contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider
  reinforcing ERNs, supporting the creation of new ERNs to cover infectious
  diseases
  , complex pregnancies and rare and complex mental health diseases. The reinforcement of ERNs can play a key role in supporting the adoption of a common newly developed screening framework at Union level, starting from disease selection criteria and mechanisms, with the aim of overcoming existing inequalities in terms of screening coverage across Member States. The Programme should also consider the development of excellence networks in the field of
  communicable and non-communicable diseases
  , including
  cancer
  and paediatric cancer, cardiovascular disease, chronic respiratory disease, diabetes, mental health conditions, neurodegenerative diseases and other major chronic diseases, and in the field of health crisis management
  .

Amendment 36

Proposal for a regulation

Recital 27 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (27 a) | The ERNs face significant challenges as regards ensuring 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’

   (16a)

  . |

Text proposed by the Commission

Amendment

(27 a)

The ERNs face significant challenges as regards ensuring 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’

   (16a)

  .

Amendment 37

Proposal for a regulation

Recital 30

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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. 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. |

Text proposed by the Commission

Amendment

(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. 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.

| (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
  , in particular 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
  , 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
  , guaranteeing detailed and transparent reporting
  . |
| --- | --- |

(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
  , in particular 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
  , 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
  , guaranteeing detailed and transparent reporting
  .

Amendment 38

Proposal for a regulation

Recital 31

| Text proposed by the Commission | Amendment |
| --- | --- |
| (31) | Given the specific nature of the objectives and actions covered by the Programme, the respective competent authorities of the Member States are best placed in some cases to implement the related activities. Those authorities, 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. |

Text proposed by the Commission

Amendment

(31)

Given the specific nature of the objectives and actions covered by the Programme, the respective competent authorities of the Member States are best placed in some cases to implement the related activities. Those authorities, 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.

| (31) | Given the specific nature of the objectives and actions covered by the Programme, the respective competent authorities of the Member States are best placed in some cases to implement the related activities. Those authorities, 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.
  Investments from the Programme should be implemented in close cooperation with Member States especially in areas falling under national competences. |
| --- | --- |

(31)

Given the specific nature of the objectives and actions covered by the Programme, the respective competent authorities of the Member States are best placed in some cases to implement the related activities. Those authorities, 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.
  Investments from the Programme should be implemented in close cooperation with Member States especially in areas falling under national competences.

Amendment 39

Proposal for a regulation

Recital 31 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (31 a) | In order to ensure that each of these objectives is implemented at Union level, the Commission should increase the budget and should submit a proposal to strengthen the mandates of the ECDC and of EMA, which are already pursuing some of the EU4Health objectives at their level, and should have a greater role in the implementation of the Programme. |

Text proposed by the Commission

Amendment

(31 a)

In order to ensure that each of these objectives is implemented at Union level, the Commission should increase the budget and should submit a proposal to strengthen the mandates of the ECDC and of EMA, which are already pursuing some of the EU4Health objectives at their level, and should have a greater role in the implementation of the Programme.

Amendment 40

Proposal for a regulation

Recital 33

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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 challenges (19), 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. |

Text proposed by the Commission

Amendment

(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 challenges (19), 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.

| (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 challenges (19), 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. |
| --- | --- |

(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 challenges (19), 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.

Amendment 41

Proposal for a regulation

Recital 34

| Text proposed by the Commission | Amendment |
| --- | --- |
| (34) | In order to maximise the effectiveness and efficiency of actions at Union and international level, cooperation should be developed 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/EU (20), 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. |

Text proposed by the Commission

Amendment

(34)

In order to maximise the effectiveness and efficiency of actions at Union and international level, cooperation should be developed 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/EU (20), 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.

| (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/EU (20), 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. |
| --- | --- |

(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/EU (20), 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.

Amendment 42

Proposal for a regulation

Recital 34 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (34 a) | The programme should guarantee that there is strong involvement of 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 organisations should contribute to the implementation and the evaluation of the programme. |

Text proposed by the Commission

Amendment

(34 a)

The programme should guarantee that there is strong involvement of 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 organisations should contribute to the implementation and the evaluation of the programme.

Amendment 43

Proposal for a regulation

Recital 34 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (34 b) | To achieve a coherent implementation of the actions included in the Programme, a EU4Health Steering Group should be established. |

Text proposed by the Commission

Amendment

(34 b)

To achieve a coherent implementation of the actions included in the Programme, a EU4Health Steering Group should be established.

Amendment 44

Proposal for a regulation

Recital 39 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (39a) | According to the WHO, climate change affects the social and environmental determinants of health, including clean air, safe drinking water, sufficient food and secure shelter, and that 250 000 additional deaths, from malnutrition, malaria, 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. |

Text proposed by the Commission

Amendment

(39a)

According to the WHO, climate change affects the social and environmental determinants of health, including clean air, safe drinking water, sufficient food and secure shelter, and that 250 000 additional deaths, from malnutrition, malaria, 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 45

Proposal for a regulation

Recital 40

| Text proposed by the Commission | Amendment |
| --- | --- |
| (40) | Reflecting the importance of tackling climate change in line with the Union's commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals, this Programme will contribute to mainstream climate action in the Union's policies and to the achievement of an overall target of
  25
  % of the EU budget expenditures supporting climate objectives. Relevant actions will be identified during the Programme's preparation and implementation, and reassessed in the context of its mid-term evaluation. |

Text proposed by the Commission

Amendment

(40)

Reflecting the importance of tackling climate change in line with the Union's commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals, this Programme will contribute to mainstream climate action in the Union's policies and to the achievement of an overall target of
  25
  % of the EU budget expenditures supporting climate objectives. Relevant actions will be identified during the Programme's preparation and implementation, and reassessed in the context of its mid-term evaluation.

| (40) | Reflecting the importance of tackling climate change in line with the Union's commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals, this Programme will contribute to mainstream climate action in the Union's policies and to the achievement of an overall target of
  30
  % of the EU budget expenditures supporting climate objectives. Relevant actions will be identified during the Programme's preparation and implementation, and reassessed in the context of its mid-term evaluation. |
| --- | --- |

(40)

Reflecting the importance of tackling climate change in line with the Union's commitments to implement the Paris Agreement and the United Nations Sustainable Development Goals, this Programme will contribute to mainstream climate action in the Union's policies and to the achievement of an overall target of
  30
  % of the EU budget expenditures supporting climate objectives. Relevant actions will be identified during the Programme's preparation and implementation, and reassessed in the context of its mid-term evaluation.

Amendment 46

Proposal for a regulation

Recital 40 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (40 a) | Recognising the importance of achieving gender equality, this Programme should contribute to mainstream gender equality in the Union's policies. It should use gender mainstreaming and gender budgeting tools to ensure that health crises are responded to in a gender- sensitive and transformative manner and that women’s and girls’ specific health needs are addressed during and in the aftermath of a health crisis. |

Text proposed by the Commission

Amendment

(40 a)

Recognising the importance of achieving gender equality, this Programme should contribute to mainstream gender equality in the Union's policies. It should use gender mainstreaming and gender budgeting tools to ensure that health crises are responded to in a gender- sensitive and transformative manner and that women’s and girls’ specific health needs are addressed during and in the aftermath of a health crisis.

Amendment 47

Proposal for a regulation

Recital 43

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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 and affordability in the Union of medicines, medical devices and other crisis relevant products, to support innovation and to support integrated and coordinated work and implementation of best practices among Member States, and to address inequalities in access to health throughout the EU in a manner that creates efficiency gains and value-added impacts that could not be generated by action taken at national level while respecting the Member States’ competence and responsibility in the areas covered by the Programme. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. |

Text proposed by the Commission

Amendment

(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 and affordability in the Union of medicines, medical devices and other crisis relevant products, to support innovation and to support integrated and coordinated work and implementation of best practices among Member States, and to address inequalities in access to health throughout the EU in a manner that creates efficiency gains and value-added impacts that could not be generated by action taken at national level while respecting the Member States’ competence and responsibility in the areas covered by the Programme. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

| (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
  should
  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, safety
  and affordability in the Union of medicines, medical devices and other
  health
  crisis relevant products
  and services
  , to support innovation and to support integrated and coordinated work and implementation of best practices among Member States
  and among their regions,
  , and to address inequalities
  and inequities
  in access to health throughout the EU in a manner that creates efficiency gains and value-added impacts that could not be generated by action taken at national level while respecting the Member States’ competence and responsibility in the areas covered by the Programme. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives. |
| --- | --- |

(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
  should
  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, safety
  and affordability in the Union of medicines, medical devices and other
  health
  crisis relevant products
  and services
  , to support innovation and to support integrated and coordinated work and implementation of best practices among Member States
  and among their regions,
  , and to address inequalities
  and inequities
  in access to health throughout the EU in a manner that creates efficiency gains and value-added impacts that could not be generated by action taken at national level while respecting the Member States’ competence and responsibility in the areas covered by the Programme. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

Amendment 49

Proposal for a regulation

Article 2 — paragraph 1 — point 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3) | ‘health crisis’ means any crisis or serious incident arising from a threat of human, animal, plant, food
  or environment
  origin, having a health dimension and which requires urgent action by authorities; |

Text proposed by the Commission

Amendment

3)

‘health crisis’ means any crisis or serious incident arising from a threat of human, animal, plant, food
  or environment
  origin, having a health dimension and which requires urgent action by authorities;

| (3) | ‘health crisis’ means any crisis or serious incident arising from a threat of human, animal, plant, food,
  chemical, biological, radiological
  ,
  nuclear
  ,
  environmental or unknown
  origin, having a health dimension and which requires urgent action by authorities; |
| --- | --- |

(3)

‘health crisis’ means any crisis or serious incident arising from a threat of human, animal, plant, food,
  chemical, biological, radiological
  ,
  nuclear
  ,
  environmental or unknown
  origin, having a health dimension and which requires urgent action by authorities;

Amendment 50

Proposal for a regulation

Article 2 — paragraph 1 — point 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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,
  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); |

Text proposed by the Commission

Amendment

(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,
  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);

| (4) | ‘crisis relevant products’ means products
  , tools
  and substances necessary, in the context of a health crisis, to prevent, diagnose or treat a disease and its consequences,
  and for the monitoring and the epidemiological surveillance of diseases and infections
  ,
  including
  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); |
| --- | --- |

(4)

‘crisis relevant products’ means products
  , tools
  and substances necessary, in the context of a health crisis, to prevent, diagnose or treat a disease and its consequences,
  and for the monitoring and the epidemiological surveillance of diseases and infections
  ,
  including
  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 48

Proposal for a regulation

Article 2 — paragraph 1 — point 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| (5) | ‘One Health approach’ means an approach which recognises
  that
  human
  and
  animal
  health are interconnected
  , that diseases may be transmitted from
  humans to animals and vice versa
  and must therefore be tackled in
  both, and that the environment links humans and animals
  ; |

Text proposed by the Commission

Amendment

(5)

‘One Health approach’ means an approach which recognises
  that
  human
  and
  animal
  health are interconnected
  , that diseases may be transmitted from
  humans to animals and vice versa
  and must therefore be tackled in
  both, and that the environment links humans and animals
  ;

| (5) | ‘One Health approach’ means an approach which recognises
  the interconnection between the
  human, animal
  and environmental spheres
  , that diseases may be transmitted from
  one pillar to another
  and must therefore be tackled in
  a holistic approach
  ; |
| --- | --- |

(5)

‘One Health approach’ means an approach which recognises
  the interconnection between the
  human, animal
  and environmental spheres
  , that diseases may be transmitted from
  one pillar to another
  and must therefore be tackled in
  a holistic approach
  ;

Amendment 51

Proposal for a regulation

Article 2 — paragraph 1 — point 9

| Text proposed by the Commission | Amendment |
| --- | --- |
| (9) | ‘serious cross-border threat to health’ means a life- threatening or otherwise serious hazard to health of biological, chemical, 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; |

Text proposed by the Commission

Amendment

(9)

‘serious cross-border threat to health’ means a life- threatening or otherwise serious hazard to health of biological, chemical, 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;

| (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; |
| --- | --- |

(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 52

Proposal for a regulation

Article 2 — paragraph 1 — point 9 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (9a) | ‘Health in all policies’ means an approach to the development, implementation and review of public policies, regardless of the sector, whereby the health implications of decisions are taken into account, and which seeks to achieve synergies, and to avoid harmful health impacts being caused by such policies, in order to improve the health of the population and health equity; |

Text proposed by the Commission

Amendment

(9a)

Amendment 53

Proposal for a regulation

Article 2 — paragraph 1– point 9 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (9b) | ‘Health determinants’ means a range of factors, such as behaviour- related, biological, socio-economic and environmental factors, that influence the health status of a person; |

Text proposed by the Commission

Amendment

(9b)

Amendment 54

Proposal for a regulation

Article 3 — paragraph 1 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| The Programme shall pursue the following general objectives, in keeping with the ‘One Health’ approach where relevant: | The Programme shall pursue the following general objectives, in keeping with the
  ‘Health in all policies’ approach where applicable
  , and with the ‘One Health’ approach: |

Text proposed by the Commission

Amendment

The Programme shall pursue the following general objectives, in keeping with the ‘One Health’ approach where relevant:

The Programme shall pursue the following general objectives, in keeping with the
  ‘Health in all policies’ approach where applicable
  , and with the ‘One Health’ approach:

Amendment 55

Proposal for a regulation

Article 3 — paragraph 1 — point 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1) | protect people
  in the Union
  from serious cross-border threats
  to health; |

Text proposed by the Commission

Amendment

1)

protect people
  in the Union
  from serious cross-border threats
  to health;

| (1) | 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; |
| --- | --- |

(1)

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;

Amendment 56

Proposal for a regulation

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

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (1a) | 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; |

Text proposed by the Commission

Amendment

(1a)

Amendment 57

Proposal for a regulation

Article 3 — paragraph 1 — point 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| (2) | improve the availability
  in the Union of medicines, medical devices and other crisis relevant products, contribute to their
  affordability, and support innovation; |

Text proposed by the Commission

Amendment

(2)

improve the availability
  in the Union of medicines, medical devices and other crisis relevant products, contribute to their
  affordability, and support innovation;

| (2) | supporting existing and future Union legislation and policies, in order to, inter alia, restore pharmaceutical independence and address shortages,
  improve the availability
  , accessibility and
  affordability
  of health care and services in the Union
  , and support
  research and
  innovation
  as well as development in health and healthcare without duplicating efforts under other programmes, including Horizon Europe
  ; |
| --- | --- |

(2)

supporting existing and future Union legislation and policies, in order to, inter alia, restore pharmaceutical independence and address shortages,
  improve the availability
  , accessibility and
  affordability
  of health care and services in the Union
  , and support
  research and
  innovation
  as well as development in health and healthcare without duplicating efforts under other programmes, including Horizon Europe
  ;

Amendment 58

Proposal for a regulation

Article 3 — paragraph 1 — point 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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. |

Text proposed by the Commission

Amendment

(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.

| (3) | strengthen health systems and
  their sustainability, as well as
  the healthcare workforce, including by digital transformation and by increased integrated and coordinated work among the Member States,
  including at national, regional and local level, by
  sustained implementation of best
  practices, and by sharing of 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
  . |
| --- | --- |

(3)

strengthen health systems and
  their sustainability, as well as
  the healthcare workforce, including by digital transformation and by increased integrated and coordinated work among the Member States,
  including at national, regional and local level, by
  sustained implementation of best
  practices, and by sharing of 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
  .

Amendment 59

Proposal for a regulation

Article 4 — paragraph 1 — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| The general objectives referred to in Article 3 shall be pursued through the following specific objectives,
  in keeping with the ‘One Health’ approach
  where relevant: | The general objectives referred to in Article 3 shall be pursued through the following specific objectives, in keeping with the
  ‘Health in all policies’ approach where applicable
  , and with the ‘One Health’ approach: |

Text proposed by the Commission

Amendment

The general objectives referred to in Article 3 shall be pursued through the following specific objectives,
  in keeping with the ‘One Health’ approach
  where relevant:

The general objectives referred to in Article 3 shall be pursued through the following specific objectives, in keeping with the
  ‘Health in all policies’ approach where applicable
  , and with the ‘One Health’ approach:

Amendment 226

Proposal for a regulation

Article 4 — paragraph 1 — point 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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; |

Text proposed by the Commission

Amendment

(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;

| (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
  , the coordination of stress testing of national healthcare systems and the development of quality healthcare standards
  ; |
| --- | --- |

(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
  , the coordination of stress testing of national healthcare systems and the development of quality healthcare standards
  ;

Amendment 250

Proposal for a regulation

Article 4 — paragraph 1 — point 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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; |

Text proposed by the Commission

Amendment

(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;

| (2) | In synergy with other
  Union
  instruments, programmes and funds, support actions to allow
  medical, healthcare and support staff to be mobilised in case of a crisis
  , such as staff of the European Medical Corps, including by improving the staff's training and updating their knowledge, and support action to contribute to the availability in the Union, during a crisis, of health crisis relevant products such as essential medicines, vaccines and medical devices
  ; |
| --- | --- |

(2)

In synergy with other
  Union
  instruments, programmes and funds, support actions to allow
  medical, healthcare and support staff to be mobilised in case of a crisis
  , such as staff of the European Medical Corps, including by improving the staff's training and updating their knowledge, and support action to contribute to the availability in the Union, during a crisis, of health crisis relevant products such as essential medicines, vaccines and medical devices
  ;

Amendment 62

Proposal for a regulation

Article 4 — paragraph 1 — point 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| (3) | support actions
  to ensure
  appropriate
  availability, accessibility and affordability of
  crisis relevant
  products and other necessary health supplies; |

Text proposed by the Commission

Amendment

(3)

support actions
  to ensure
  appropriate
  availability, accessibility and affordability of
  crisis relevant
  products and other necessary health supplies;

| (3) | strengthen the European Medicines Market,
  to ensure
  in a sustainable manner the
  availability, accessibility and affordability of
  medicinal
  products
  , e-health solutions, medical devices
  and other necessary health
  related
  supplies
  and crisis relevant medical products
  ; |
| --- | --- |

(3)

strengthen the European Medicines Market,
  to ensure
  in a sustainable manner the
  availability, accessibility and affordability of
  medicinal
  products
  , e-health solutions, medical devices
  and other necessary health
  related
  supplies
  and crisis relevant medical products
  ;

Amendment 222

Proposal for a regulation

Article 4 — paragraph 1 — point 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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
  universal health coverage,
  and address
  inequalities in health; |

Text proposed by the Commission

Amendment

(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
  universal health coverage,
  and address
  inequalities in health;

| (4) | strengthen the effectiveness, accessibility, sustainability and resilience of health systems, including by supporting digital transformation,
  including the creation and implementation of a European Health Data Space
  systemic reforms, implementation of new care models
  , enhance the equal and timely access to quality, sustainable, affordable, person-centred, outcome-based healthcare and related care services, the achievement of
  universal health coverage,
  encompassing access to sexual and reproductive health and rights, and reduce
  inequalities
  and inequities
  in health; |
| --- | --- |

(4)

strengthen the effectiveness, accessibility, sustainability and resilience of health systems, including by supporting digital transformation,
  including the creation and implementation of a European Health Data Space
  systemic reforms, implementation of new care models
  , enhance the equal and timely access to quality, sustainable, affordable, person-centred, outcome-based healthcare and related care services, the achievement of
  universal health coverage,
  encompassing access to sexual and reproductive health and rights, and reduce
  inequalities
  and inequities
  in health;

Amendment 64

Proposal for a regulation

Article 4 — paragraph 1 — point 4 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (4a) | strengthen the Union’s innovation to ensure the development and uptake of the next generation of medicines, vaccines and medical devices to meet increasing healthcare challenges and expectations that arise; |

Text proposed by the Commission

Amendment

(4a)

Amendment 65

Proposal for a regulation

Article 4 — paragraph 1 — point 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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
  ; |

Text proposed by the Commission

Amendment

(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
  ;

| (5) | support actions aimed at strengthening health system’s ability to foster disease prevention
  , screening and early diagnosis, and implement
  health promotion
  , address health determinants, improve health literacy
  , patient rights
  and safety
  and cross-border healthcare; |
| --- | --- |

(5)

support actions aimed at strengthening health system’s ability to foster disease prevention
  , screening and early diagnosis, and implement
  health promotion
  , address health determinants, improve health literacy
  , patient rights
  and safety
  and cross-border healthcare;

Amendment 245

Proposal for a regulation

Article 4 — paragraph 1 — point 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| (6) | support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer; |

Text proposed by the Commission

Amendment

(6)

support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer;

| (6) | support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases,
  the early diagnosis of neurodegenerative disorders and other brain diseases,
  and notably of cancer; |
| --- | --- |

(6)

support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases,
  the early diagnosis of neurodegenerative disorders and other brain diseases,
  and notably of cancer;

Amendment 66

Proposal for a regulation

Article 4 — paragraph 1 — point 6 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (6a) | 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, and by supporting the establishment of the European Cancer Institute; |

Text proposed by the Commission

Amendment

(6a)

Amendment 67

Proposal for a regulation

Article 4 — paragraph 1 — point 6 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (6b) | strengthen the fight against communicable diseases and health threats; |

Text proposed by the Commission

Amendment

(6b)

Amendment 68

Proposal for a regulation

Article 4 — paragraph 1 — point 6 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (6c) | address vaccine hesitancy, and support action for the elimination of vaccine preventable diseases, including cancers; |

Text proposed by the Commission

Amendment

(6c)

Amendment 69

Proposal for a regulation

Article 4 — paragraph 1 — point 7

| Text proposed by the Commission | Amendment |
| --- | --- |
| (7) | foster and support the prudent and efficient use of medicines, and in particular of antimicrobials,
  and
  more environmentally friendly production
  and
  disposal of
  medicines
  and medical devices; |

Text proposed by the Commission

Amendment

(7)

foster and support the prudent and efficient use of medicines, and in particular of antimicrobials,
  and
  more environmentally friendly production
  and
  disposal of
  medicines
  and medical devices;

| (7) | foster and support the
  informed,
  prudent and efficient use of medicines, and in particular of antimicrobials,
  the development of medicines that are intrinsically less harmful for the environment,
  more environmentally friendly production
  of medicines and environmentally sound
  disposal of
  medicinal products
  and medical devices; |
| --- | --- |

(7)

foster and support the
  informed,
  prudent and efficient use of medicines, and in particular of antimicrobials,
  the development of medicines that are intrinsically less harmful for the environment,
  more environmentally friendly production
  of medicines and environmentally sound
  disposal of
  medicinal products
  and medical devices;

Amendment 70

Proposal for a regulation

Article 4 — paragraph 1 — point 8

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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; |

Text proposed by the Commission

Amendment

(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;

| (8) | support the development, implementation and enforcement
  and, when necessary, the revision,
  of Union health legislation, and provide high-quality, comparable, and reliable, data to underpin policy making and monitoring
  , support the delivery of care and respond to unmet medical needs
  , and promote the use of health impact assessments of
  other
  relevant
  Union
  policies; |
| --- | --- |

(8)

support the development, implementation and enforcement
  and, when necessary, the revision,
  of Union health legislation, and provide high-quality, comparable, and reliable, data to underpin policy making and monitoring
  , support the delivery of care and respond to unmet medical needs
  , and promote the use of health impact assessments of
  other
  relevant
  Union
  policies;

Amendments 246 and 71

Proposal for a regulation

Article 4 — paragraph 1 — point 9

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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; |

Text proposed by the Commission

Amendment

(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;

| (9) | support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices,
  support the identification of health technologies that are required to undergo a Union assessment, and strengthening
  and scaling up networking through the
  ERNs, develop and implement excellence
  networks
  for high prevalence communicable and non-communicable diseases
  and other transnational networks
  , including the Orphanet network, in full synergy with Horizon Europe and its Missions and Partnerships, and aim to to increase the coverage of patients and the response to diseases, and health problems, in greater numbers
  ; |
| --- | --- |

(9)

support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices,
  support the identification of health technologies that are required to undergo a Union assessment, and strengthening
  and scaling up networking through the
  ERNs, develop and implement excellence
  networks
  for high prevalence communicable and non-communicable diseases
  and other transnational networks
  , including the Orphanet network, in full synergy with Horizon Europe and its Missions and Partnerships, and aim to to increase the coverage of patients and the response to diseases, and health problems, in greater numbers
  ;

Amendment 223

Proposal for a regulation

Article 4 — paragraph 1 — point 10

| Text proposed by the Commission | Amendment |
| --- | --- |
| (10) | support the Union’s contribution to international and global health initiatives. |

Text proposed by the Commission

Amendment

(10)

support the Union’s contribution to international and global health initiatives.

| (10) | support the Union’s contribution to international and global health
  commitments and
  initiatives
  , including access to sexual and reproductive health and rights
  . |
| --- | --- |

(10)

support the Union’s contribution to international and global health
  commitments and
  initiatives
  , including access to sexual and reproductive health and rights
  .

Amendment 73

Proposal for a regulation

Article 5 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   The financial envelope for the implementation of the Programme for the period 2021-27 shall be EUR
  1 946 614 000
  in current prices. | 1.   The 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)
  . |

Text proposed by the Commission

Amendment

1.   The financial envelope for the implementation of the Programme for the period 2021-27 shall be EUR
  1 946 614 000
  in current prices.

1.   The 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)
  .

Amendment 74

Amendment 74

Proposal for a regulation

Proposal for a regulation

Article 5 — paragraph 2

Article 5 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The amount referred to in paragraph 1 may be used 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. | 2.   The amount referred to in paragraph 1 may be
  also
  used 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.
  The administrative expenses related to indirect actions shall not exceed 5 % of the total amount under the Programme. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The amount referred to in paragraph 1 may be used 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.

2.   The amount referred to in paragraph 1 may be
  also
  used 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.
  The administrative expenses related to indirect actions shall not exceed 5 % of the total amount under the Programme.

Amendment 75

Amendment 75

Proposal for a regulation

Proposal for a regulation

Article 6

Article 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| Article 6 | deleted |
| Resources from the European Union Recovery Instrument | |
| Measures referred to in Article 2 of Regulation [European Union Recovery Instrument] shall be implemented under the Programme through an amount of up to EUR 8 451 000 000 in current prices referred to in point (iii) of Article 3(2)(a) of that Regulation, subject to its Article 5(4) and (8). | |
| These amounts shall constitute external assigned revenue in accordance with Article 21(5) of Regulation (EU, Euratom) 2018/1046. | |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Article 6

Article 6

deleted

deleted

Resources from the European Union Recovery Instrument

Resources from the European Union Recovery Instrument

Measures referred to in Article 2 of Regulation [European Union Recovery Instrument] shall be implemented under the Programme through an amount of up to EUR 8 451 000 000 in current prices referred to in point (iii) of Article 3(2)(a) of that Regulation, subject to its Article 5(4) and (8).

Measures referred to in Article 2 of Regulation [European Union Recovery Instrument] shall be implemented under the Programme through an amount of up to EUR 8 451 000 000 in current prices referred to in point (iii) of Article 3(2)(a) of that Regulation, subject to its Article 5(4) and (8).

These amounts shall constitute external assigned revenue in accordance with Article 21(5) of Regulation (EU, Euratom) 2018/1046.

These amounts shall constitute external assigned revenue in accordance with Article 21(5) of Regulation (EU, Euratom) 2018/1046.

Amendment 76

Amendment 76

Proposal for a regulation

Proposal for a regulation

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

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

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (1 a) | The contributions of all associated countries shall be included in the relevant parts of the Programme. The Commission shall report to the Council and the Parliament during the annual budgetary procedure the total budget of each part of the Programme, identifying each of the associated countries, individual contributions and their financial balance. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(1 a)

(1 a)

The contributions of all associated countries shall be included in the relevant parts of the Programme. The Commission shall report to the Council and the Parliament during the annual budgetary procedure the total budget of each part of the Programme, identifying each of the associated countries, individual contributions and their financial balance.

Amendment 77

Amendment 77

Proposal for a regulation

Proposal for a regulation

Article 8 — paragraph 1

Article 8 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 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. | 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
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

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.

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 78

Amendment 78

Proposal for a regulation

Proposal for a regulation

Article 8 — paragraph 2

Article 8 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The Programme may provide funding in any of the forms laid down in Regulation (EU, Euratom) 2018/1046, in particular grants, prizes and procurement. | 2.   The Programme may provide funding in any of the forms laid down in Regulation (EU, Euratom) 2018/1046, in particular grants, prizes and procurement.
  The Commission shall seek to achieve effective and balanced geographical coverage across the Union, including by supporting Member States to increase the quality of the projects through capacity building. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The Programme may provide funding in any of the forms laid down in Regulation (EU, Euratom) 2018/1046, in particular grants, prizes and procurement.

2.   The Programme may provide funding in any of the forms laid down in Regulation (EU, Euratom) 2018/1046, in particular grants, prizes and procurement.
  The Commission shall seek to achieve effective and balanced geographical coverage across the Union, including by supporting Member States to increase the quality of the projects through capacity building.

Amendment 79

Amendment 79

Proposal for a regulation

Proposal for a regulation

Article 8 — paragraph 4 a (new)

Article 8 — paragraph 4 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 4 a.
     
  The Commission shall facilitate the consistent implementation of the Programme while seeking maximal administrative simplification. The Commission and the Member States shall, commensurate to their respective responsibilities, foster synergies and ensure effective coordination between the Programme and the other Union programmes and funds. |
| | For that purpose, they shall: |
| | (a) | ensure that there is complementarity, synergy, coherence and consistency among different instruments at Union, national and, where appropriate, regional levels, in particular in relation to measures financed by Union funds, both in the planning phase and during implementation; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4 a.
     
  The Commission shall facilitate the consistent implementation of the Programme while seeking maximal administrative simplification. The Commission and the Member States shall, commensurate to their respective responsibilities, foster synergies and ensure effective coordination between the Programme and the other Union programmes and funds.

For that purpose, they shall:

For that purpose, they shall:

(a)

(a)

ensure that there is complementarity, synergy, coherence and consistency among different instruments at Union, national and, where appropriate, regional levels, in particular in relation to measures financed by Union funds, both in the planning phase and during implementation;

ensure that there is complementarity, synergy, coherence and consistency among different instruments at Union, national and, where appropriate, regional levels, in particular in relation to measures financed by Union funds, both in the planning phase and during implementation;

| (b) | optimise coordination mechanisms to avoid duplication of effort; |
| --- | --- |

(b)

(b)

optimise coordination mechanisms to avoid duplication of effort;

optimise coordination mechanisms to avoid duplication of effort;

| (c) | ensure that close cooperation exists between those responsible for implementation at Union, national and, where appropriate, regional levels to deliver coherent and streamlined support actions under the instrument. |
| --- | --- |

(c)

(c)

ensure that close cooperation exists between those responsible for implementation at Union, national and, where appropriate, regional levels to deliver coherent and streamlined support actions under the instrument.

ensure that close cooperation exists between those responsible for implementation at Union, national and, where appropriate, regional levels to deliver coherent and streamlined support actions under the instrument.

Amendment 80

Amendment 80

Proposal for a regulation

Proposal for a regulation

Article 8 — paragraph 4 b (new)

Article 8 — paragraph 4 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 4b.
     
  The Commission shall develop cooperation with relevant international organisations such as the United Nations and its specialised agencies, in particular the World Health Organisation (WHO), as well as with the Council of Europe and the Organisation for Economic Co-operation and Development (OECD) when implementing the Programme, in order to maximise the effectiveness and efficiency of actions at Union and international level. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4b.
     
  The Commission shall develop cooperation with relevant international organisations such as the United Nations and its specialised agencies, in particular the World Health Organisation (WHO), as well as with the Council of Europe and the Organisation for Economic Co-operation and Development (OECD) when implementing the Programme, in order to maximise the effectiveness and efficiency of actions at Union and international level.

Amendment 81

Amendment 81

Proposal for a regulation

Proposal for a regulation

Article 8 — paragraph 4 c (new)

Article 8 — paragraph 4 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 4c.
     
  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 or in other relevant Commission expert groups as well as stakeholders, in particular professional bodies in the health sector and NGOs active in the field, at all stages of the implementation of the Programme . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4c.
     
  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 or in other relevant Commission expert groups as well as stakeholders, in particular professional bodies in the health sector and NGOs active in the field, at all stages of the implementation of the Programme .

Amendment 82

Amendment 82

Proposal for a regulation

Proposal for a regulation

Article 9 a (new)

Article 9 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 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 the specific objectives provided for in Article 4; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Article 9a

Article 9a

Award criteria

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:

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)

(a)

consistency with the specific objectives provided for in Article 4;

consistency with the specific objectives provided for in Article 4;

| (b) | contribution to the accessibility and affordability of the health system; |
| --- | --- |

(b)

(b)

contribution to the accessibility and affordability of the health system;

contribution to the accessibility and affordability of the health system;

| (c) | cross-border dimension; |
| --- | --- |

(c)

(c)

cross-border dimension;

cross-border dimension;

| (d) | contribution to digital transformation; |
| --- | --- |

(d)

(d)

contribution to digital transformation;

contribution to digital transformation;

| (e) | social impact (benefits and costs); |
| --- | --- |

(e)

(e)

social impact (benefits and costs);

social impact (benefits and costs);

| (f) | consistency with the provisions of Annex 1; |
| --- | --- |

(f)

(f)

consistency with the provisions of Annex 1;

consistency with the provisions of Annex 1;

| (g) | contribution to the prevention of diseases and notably of cancer; |
| --- | --- |

(g)

(g)

contribution to the prevention of diseases and notably of cancer;

contribution to the prevention of diseases and notably of cancer;

| (h) | contribution to access to medicine; |
| --- | --- |

(h)

(h)

contribution to access to medicine;

contribution to access to medicine;

| (i) | maturity of the action in the project development; |
| --- | --- |

(i)

(i)

maturity of the action in the project development;

maturity of the action in the project development;

| (j) | soundness of the implementation plan proposed. |
| --- | --- |

(j)

(j)

soundness of the implementation plan proposed.

soundness of the implementation plan proposed.

Amendment 83

Amendment 83

Proposal for a regulation

Proposal for a regulation

Article 12 — paragraph 3 a (new)

Article 12 — paragraph 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 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 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

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 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.

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 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 84

Amendment 84

Proposal for a regulation

Proposal for a regulation

Article 14 — paragraph 1 — point b

Article 14 — paragraph 1 — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (b) | any legal entity created under Union law or any international organisation; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(b)

any legal entity created under Union law or any international organisation;

| (b) | any legal entity created under Union law or any
  relevant
  international organisation
  such as public authorities, public sector bodies, health establishments, research institutes, universities and higher education establishments, patient associations
  ; |
| --- | --- |

(b)

any legal entity created under Union law or any
  relevant
  international organisation
  such as public authorities, public sector bodies, health establishments, research institutes, universities and higher education establishments, patient associations
  ;

relevant

such as public authorities, public sector bodies, health establishments, research institutes, universities and higher education establishments, patient associations

Amendment 85

Amendment 85

Proposal for a regulation

Proposal for a regulation

Article 14 — paragraph 3

Article 14 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   Legal entities established in a third country which is not associated to the Programme should
  in principle
  bear the cost of their participation. | 3.   Legal entities established in a third country which is not associated to the Programme should bear the cost of their participation. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   Legal entities established in a third country which is not associated to the Programme should
  in principle
  bear the cost of their participation.

3.   Legal entities established in a third country which is not associated to the Programme should bear the cost of their participation.

Amendment 86

Amendment 86

Proposal for a regulation

Proposal for a regulation

Article 14 — paragraph 5

Article 14 — paragraph 5

| Text proposed by the Commission | Amendment |
| --- | --- |
| 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 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 public sector bodies and non-governmental bodies, acting individually or as a network, mandated by those competent authorities. | 5.   Under the Programme, direct grants may be awarded without a call for proposals to fund actions
  if such grants are duly justified, if they have
  a clear Union added value co-financed by the
  local, regional or 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

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 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 public sector bodies and non-governmental bodies, acting individually or as a network, mandated by those competent authorities.

5.   Under the Programme, direct grants may be awarded without a call for proposals to fund actions
  if such grants are duly justified, if they have
  a clear Union added value co-financed by the
  local, regional or 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 87

Amendment 87

Proposal for a regulation

Proposal for a regulation

Article 14 — paragraph 6

Article 14 — paragraph 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| 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 set out in accordance with
  EU rules
  . | 6.   Under the Programme, direct grants
  shall
  be awarded without a call for proposals to
  ERNs with a simplified financial and technical reporting system
  . Direct grants may also be awarded to other transnational networks,
  including to Interreg programmes,
  set out in accordance with
  Union law
  . |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

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 set out in accordance with
  EU rules
  .

6.   Under the Programme, direct grants
  shall
  be awarded without a call for proposals to
  ERNs with a simplified financial and technical reporting system
  . Direct grants may also be awarded to other transnational networks,
  including to Interreg programmes,
  set out in accordance with
  Union law
  .

Amendment 88

Amendment 88

Proposal for a regulation

Proposal for a regulation

Article 14 — paragraph 6 a (new)

Article 14 — paragraph 6 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 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 opinions and specialist advice for patients on treatment and management and ‘online out-patient’ clinics. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

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 opinions and specialist advice for patients on treatment and management and ‘online out-patient’ clinics.

Amendment 89

Amendment 89

Proposal for a regulation

Proposal for a regulation

Article 16 — paragraph 1

Article 16 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 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 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
  annual
  work plans established for the Programme and its priorities and strategic orientations and its implementation
  and on possible synergies with Member States’ own resources to ensure long-term effectiveness and sustainability of actions. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

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 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
  annual
  work plans established for the Programme and its priorities and strategic orientations and its implementation
  and on possible synergies with Member States’ own resources to ensure long-term effectiveness and sustainability of actions.

annual

and on possible synergies with Member States’ own resources to ensure long-term effectiveness and sustainability of actions.

Amendment 90

Amendment 90

Proposal for a regulation

Proposal for a regulation

Article 16 — paragraph 1 a (new)

Article 16 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | The Commission shall consult the EU4Health Steering Group on the annual work plans established for the Programme and on the Programme’s priorities, strategic orientations and implementation, and on possible synergies with European funds to ensure the long-term effectiveness and sustainability of actions. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The Commission shall consult the EU4Health Steering Group on the annual work plans established for the Programme and on the Programme’s priorities, strategic orientations and implementation, and on possible synergies with European funds to ensure the long-term effectiveness and sustainability of actions.

The Commission shall consult the EU4Health Steering Group on the annual work plans established for the Programme and on the Programme’s priorities, strategic orientations and implementation, and on possible synergies with European funds to ensure the long-term effectiveness and sustainability of actions.

Amendment 91

Amendment 91

Proposal for a regulation

Proposal for a regulation

Article 16 — paragraph 1 b (new)

Article 16 — paragraph 1 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | The Commission shall also consult relevant Union decentralised agencies and stakeholders, such as representatives of civil society organisations, in particular patients’ organisations, on the annual work plans established for the Programme and the Programme’s priorities, strategic orientations and implementation. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The Commission shall also consult relevant Union decentralised agencies and stakeholders, such as representatives of civil society organisations, in particular patients’ organisations, on the annual work plans established for the Programme and the Programme’s priorities, strategic orientations and implementation.

The Commission shall also consult relevant Union decentralised agencies and stakeholders, such as representatives of civil society organisations, in particular patients’ organisations, on the annual work plans established for the Programme and the Programme’s priorities, strategic orientations and implementation.

Amendment 92

Amendment 92

Proposal for a regulation

Proposal for a regulation

Article 16 — paragraph 1 c (new)

Article 16 — paragraph 1 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | The Commission shall adopt the annual work plans by means of delegated acts. Those delegated acts shall be adopted in accordance with Article 24 of this Regulation. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The Commission shall adopt the annual work plans by means of delegated acts. Those delegated acts shall be adopted in accordance with Article 24 of this Regulation.

The Commission shall adopt the annual work plans by means of delegated acts. Those delegated acts shall be adopted in accordance with Article 24 of this Regulation.

Amendment 93

Amendment 93

Proposal for a regulation

Proposal for a regulation

Article 16 a (new)

Article 16 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Article 16 a |
| | Establishment of EU4Health Steering Group |
| | 1.
     
  The Commission shall establish a EU4Health Steering Group (‘the Steering Group’). |
| | 2.
     
  The Steering Group shall: |
| | (i) | provide input, in the form of a comprehensive strategy and steering, and contribute to the annual work plans for the Programme; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Article 16 a

Article 16 a

Establishment of EU4Health Steering Group

Establishment of EU4Health Steering Group

1.
     
  The Commission shall establish a EU4Health Steering Group (‘the Steering Group’).

2.
     
  The Steering Group shall:

(i)

(i)

provide input, in the form of a comprehensive strategy and steering, and contribute to the annual work plans for the Programme;

provide input, in the form of a comprehensive strategy and steering, and contribute to the annual work plans for the Programme;

| (ii) | elaborate a blueprint for steering coordination, cooperation and synergies between the Programme and other Programmes in which a health dimension is integrated; |
| --- | --- |

(ii)

(ii)

elaborate a blueprint for steering coordination, cooperation and synergies between the Programme and other Programmes in which a health dimension is integrated;

elaborate a blueprint for steering coordination, cooperation and synergies between the Programme and other Programmes in which a health dimension is integrated;

| (iii) | provide value-oriented health actions, sustainability, better health solutions, foster access to health and reduce health inequalities, promote engagement by patients and society. |
| --- | --- |

(iii)

(iii)

provide value-oriented health actions, sustainability, better health solutions, foster access to health and reduce health inequalities, promote engagement by patients and society.

provide value-oriented health actions, sustainability, better health solutions, foster access to health and reduce health inequalities, promote engagement by patients and society.

3.
     
  The Steering Group shall be an independent stakeholder group, composed of actors in the field of public health, such as representatives of the European Parliament, independent health experts and patient representatives.

4.
     
  The Steering Group shall be composed of 20 high-level individuals respecting the principle of geographical and gender balance, drawn from various disciplines and activities referred to in paragraph 3.

5.
     
  The members of the Steering Board shall be appointed by the Commission in consultation with the Parliament, following an open call for nominations or for expression of interest.

The members shall be appointed for the period referred to in Article 1(2). The Commission shall also appoint a Chair from among its members.

6.
     
  The Steering Group shall meet at least three times a year, which allows regular and transparent exchanges of views.

The blueprint for steering coordination, cooperation and synergies shall facilitate ensuring visibility and coordination of all the existing financial mechanisms relevant to health, and shall help to steer coordination and cooperation.

The blueprint for steering coordination, cooperation and synergies shall facilitate ensuring visibility and coordination of all the existing financial mechanisms relevant to health, and shall help to steer coordination and cooperation.

The Commission may consult the Steering Group on matters other than those referred to in paragraph 2.

The Commission may consult the Steering Group on matters other than those referred to in paragraph 2.

Amendment 94

Proposal for a regulation

Proposal for a regulation

Article 18 — paragraph 1

Article 18 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| The Programme shall be implemented by 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. | 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The Programme shall be implemented by 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.

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.

annual

Amendment 95

Amendment 95

Proposal for a regulation

Proposal for a regulation

Article 18 — paragraph 1 a (new)

Article 18 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | The work programmes shall be informed by a gender impact assessment. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The work programmes shall be informed by a gender impact assessment.

The work programmes shall be informed by a gender impact assessment.

Amendment 96

Amendment 96

Proposal for a regulation

Proposal for a regulation

Article 19 — paragraph 1

Article 19 — paragraph 1

| Text proposed by the Commission | Amendment |
| --- | --- |
| 1.   Indicators to report on progress of the Programme towards the achievement of the general and specific objectives set out in Articles 3 and 4 are set out in Annex II. | 1.   Indicators
  , including programme- and action-specific indicators,
  to report on progress of the Programme towards the achievement of the general and specific objectives set out in Articles 3 and 4 are set out in Annex II. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1.   Indicators to report on progress of the Programme towards the achievement of the general and specific objectives set out in Articles 3 and 4 are set out in Annex II.

1.   Indicators
  , including programme- and action-specific indicators,
  to report on progress of the Programme towards the achievement of the general and specific objectives set out in Articles 3 and 4 are set out in Annex II.

Amendment 97

Amendment 97

Proposal for a regulation

Proposal for a regulation

Article 19 — paragraph 1 a (new)

Article 19 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1 a.
     
  The Commission shall monitor continuously the management and implementation of the Programme. In order to enhance transparency, the constantly updated data on the management and implementation shall be made publicly available in an accessible manner on the Commission's website. |
| | In particular, data for projects funded shall be included in the same database. Those data shall include: |
| | (a) | information on the types of financing and the types of beneficiaries, that allows for a transparent tracking of the financial allocations; a detailed overview of the synergies with other Union programmes, including the activities implemented by Union agencies, that allows for a proper analysis of the complementarity between different activities to be carried out. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1 a.
     
  The Commission shall monitor continuously the management and implementation of the Programme. In order to enhance transparency, the constantly updated data on the management and implementation shall be made publicly available in an accessible manner on the Commission's website.

In particular, data for projects funded shall be included in the same database. Those data shall include:

In particular, data for projects funded shall be included in the same database. Those data shall include:

(a)

(a)

information on the types of financing and the types of beneficiaries, that allows for a transparent tracking of the financial allocations; a detailed overview of the synergies with other Union programmes, including the activities implemented by Union agencies, that allows for a proper analysis of the complementarity between different activities to be carried out.

information on the types of financing and the types of beneficiaries, that allows for a transparent tracking of the financial allocations; a detailed overview of the synergies with other Union programmes, including the activities implemented by Union agencies, that allows for a proper analysis of the complementarity between different activities to be carried out.

| (b) | the levels of expenditure disaggregated at project level in order to allow for specific analysis, including per intervention area as defined in Article 13 and Annex I. |
| --- | --- |

(b)

(b)

the levels of expenditure disaggregated at project level in order to allow for specific analysis, including per intervention area as defined in Article 13 and Annex I.

the levels of expenditure disaggregated at project level in order to allow for specific analysis, including per intervention area as defined in Article 13 and Annex I.

Amendment 98

Amendment 98

Proposal for a regulation

Proposal for a regulation

Article 19 — paragraph 2

Article 19 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The Commission is empowered to adopt delegated acts in accordance with Article 24 concerning amendments to Annex II to amend and supplement the indicators where considered necessary. | 2.   The Commission is empowered to adopt delegated acts in accordance with Article 24 concerning amendments to Annex II to amend and supplement the indicators
  , including programme- and action-specific ones,
  where considered necessary. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The Commission is empowered to adopt delegated acts in accordance with Article 24 concerning amendments to Annex II to amend and supplement the indicators where considered necessary.

2.   The Commission is empowered to adopt delegated acts in accordance with Article 24 concerning amendments to Annex II to amend and supplement the indicators
  , including programme- and action-specific ones,
  where considered necessary.

Amendment 99

Amendment 99

Proposal for a regulation

Proposal for a regulation

Article 19 — paragraph 2 a (new)

Article 19 — paragraph 2 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 2 a.
     
  Indicators shall be collected, where relevant, dissagregated by gender. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2 a.
     
  Indicators shall be collected, where relevant, dissagregated by gender.

Amendment 100

Amendment 100

Proposal for a regulation

Proposal for a regulation

Article 19 — paragraph 3

Article 19 — paragraph 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3.   The performance reporting system shall ensure that data for monitoring programme implementation and results are collected efficiently, effectively, and in a timely manner. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where relevant, on Member States. | 3.   The performance reporting system shall ensure that data for monitoring programme implementation and results are collected efficiently, effectively, and in a timely manner
  without increasing the administrative burden for beneficiaries
  . To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where relevant, on Member States. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.   The performance reporting system shall ensure that data for monitoring programme implementation and results are collected efficiently, effectively, and in a timely manner. To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where relevant, on Member States.

3.   The performance reporting system shall ensure that data for monitoring programme implementation and results are collected efficiently, effectively, and in a timely manner
  without increasing the administrative burden for beneficiaries
  . To that end, proportionate reporting requirements shall be imposed on recipients of Union funds and, where relevant, on Member States.

Amendment 101

Amendment 101

Proposal for a regulation

Proposal for a regulation

Article 20 — paragraph 4

Article 20 — paragraph 4

| Text proposed by the Commission | Amendment |
| --- | --- |
| 4.   The Commission shall communicate the conclusions of the evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. | 4.   The Commission shall
  publish,
  communicate
  and present
  the conclusions of
  both
  the
  interim and final
  evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

4.   The Commission shall communicate the conclusions of the evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

4.   The Commission shall
  publish,
  communicate
  and present
  the conclusions of
  both
  the
  interim and final
  evaluations accompanied by its observations, to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.

Amendment 102

Amendment 102

Proposal for a regulation

Proposal for a regulation

Article 21 — paragraph 1 a (new)

Article 21 — paragraph 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | The audit system for the Programme shall ensure an appropriate balance between trust and control, taking into account administrative and other costs of controls at all levels, especially for beneficiaries. Audit rules shall be clear, consistent and coherent throughout the Programme. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The audit system for the Programme shall ensure an appropriate balance between trust and control, taking into account administrative and other costs of controls at all levels, especially for beneficiaries. Audit rules shall be clear, consistent and coherent throughout the Programme.

The audit system for the Programme shall ensure an appropriate balance between trust and control, taking into account administrative and other costs of controls at all levels, especially for beneficiaries. Audit rules shall be clear, consistent and coherent throughout the Programme.

Amendment 103

Amendment 103

Proposal for a regulation

Proposal for a regulation

Article 21 — paragraph 1 b (new)

Article 21 — paragraph 1 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | The audit strategy for the Programme shall be based on the financial audit of a representative sample of expenditure across the Programme as a whole. The representative sample shall be complemented by a selection based on an assessment of the risks related to expenditure. Actions that receive joint funding from different Union programmes shall be audited only once, covering all programmes involved and their respective applicable rules. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The audit strategy for the Programme shall be based on the financial audit of a representative sample of expenditure across the Programme as a whole. The representative sample shall be complemented by a selection based on an assessment of the risks related to expenditure. Actions that receive joint funding from different Union programmes shall be audited only once, covering all programmes involved and their respective applicable rules.

The audit strategy for the Programme shall be based on the financial audit of a representative sample of expenditure across the Programme as a whole. The representative sample shall be complemented by a selection based on an assessment of the risks related to expenditure. Actions that receive joint funding from different Union programmes shall be audited only once, covering all programmes involved and their respective applicable rules.

Amendment 104

Amendment 104

Proposal for a regulation

Proposal for a regulation

Article 21 — paragraph 1 c (new)

Article 21 — paragraph 1 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | The Commission or the funding body may rely on combined system reviews at beneficiary level. Such combined reviews shall be optional for certain types of beneficiaries and shall consist in a systems and process audit, complemented by an audit of transactions, carried out by a competent independent auditor qualified to carry out statutory audits of accounting documents in accordance with Directive 2006/43/EC

   (1a)

  .


  They may be used by the Commission or funding body to verify overall assurance on the sound financial management of expenditure and for reconsideration of the level of ex-post audits and certificates on financial statements. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The Commission or the funding body may rely on combined system reviews at beneficiary level. Such combined reviews shall be optional for certain types of beneficiaries and shall consist in a systems and process audit, complemented by an audit of transactions, carried out by a competent independent auditor qualified to carry out statutory audits of accounting documents in accordance with Directive 2006/43/EC

   (1a)

  .


  They may be used by the Commission or funding body to verify overall assurance on the sound financial management of expenditure and for reconsideration of the level of ex-post audits and certificates on financial statements.

The Commission or the funding body may rely on combined system reviews at beneficiary level. Such combined reviews shall be optional for certain types of beneficiaries and shall consist in a systems and process audit, complemented by an audit of transactions, carried out by a competent independent auditor qualified to carry out statutory audits of accounting documents in accordance with Directive 2006/43/EC

1a

.

They may be used by the Commission or funding body to verify overall assurance on the sound financial management of expenditure and for reconsideration of the level of ex-post audits and certificates on financial statements.

Amendment 105

Amendment 105

Proposal for a regulation

Proposal for a regulation

Article 21 — paragraph 1 d (new)

Article 21 — paragraph 1 d (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | Audits may be carried out up to two years after the payment of the balance. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

Audits may be carried out up to two years after the payment of the balance.

Audits may be carried out up to two years after the payment of the balance.

Amendment 106

Amendment 106

Proposal for a regulation

Proposal for a regulation

Article 21 — paragraph 1 e (new)

Article 21 — paragraph 1 e (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | The Commission shall publish audit guidelines with the aim of ensuring that there is reliable and uniform application and interpretation of the audit procedures and rules throughout the duration of the programme. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

The Commission shall publish audit guidelines with the aim of ensuring that there is reliable and uniform application and interpretation of the audit procedures and rules throughout the duration of the programme.

The Commission shall publish audit guidelines with the aim of ensuring that there is reliable and uniform application and interpretation of the audit procedures and rules throughout the duration of the programme.

Amendment 107

Amendment 107

Proposal for a regulation

Proposal for a regulation

Article 24 — paragraph 2

Article 24 — paragraph 2

| Text proposed by the Commission | Amendment |
| --- | --- |
| 2.   The power to adopt delegated acts referred to in Article 19(2) shall be conferred on the Commission
  until 31 December 2028
  . | 2.   The power to adopt delegated acts referred to in Article 19(2) shall be conferred on the Commission
  for a period of three years from [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the three-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

2.   The power to adopt delegated acts referred to in Article 19(2) shall be conferred on the Commission
  until 31 December 2028
  .

2.   The power to adopt delegated acts referred to in Article 19(2) shall be conferred on the Commission
  for a period of three years from [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the three-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

Amendment 108

Amendment 108

Proposal for a regulation

Proposal for a regulation

Annex I — point a — point ii

Annex I — point a — point ii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(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.

Critical health infrastructure

| (ii) | Coordinated action
  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. |
| --- | --- |

(ii)

Coordinated action
  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.

Coordinated action

, mechanisms

Amendment 109

Amendment 109

Proposal for a regulation

Proposal for a regulation

Annex I — point b

Annex I — point b

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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, with the highest needs, through the funding of specific projects including twinning, expert advice and peer support. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(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, with the highest needs, through the funding of specific projects including twinning, expert advice and peer support.

| (b) | Transfer, adaptation and roll-out of best practices and innovative solutions with established Union level added-value between Member States
  or regions
  , and country-specific tailor made support to
  regions or
  countries, or groups of
  regions or
  countries, with the highest needs, through the funding of specific projects including twinning, expert advice and peer support. |
| --- | --- |

(b)

Transfer, adaptation and roll-out of best practices and innovative solutions with established Union level added-value between Member States
  or regions
  , and country-specific tailor made support to
  regions or
  countries, or groups of
  regions or
  countries, with the highest needs, through the funding of specific projects including twinning, expert advice and peer support.

or regions

regions or

regions or

Amendment 110

Amendment 110

Proposal for a regulation

Proposal for a regulation

Annex I — point c — point i

Annex I — point c — point i

| Text proposed by the Commission | Amendment |
| --- | --- |
| (i) | Surveys, studies, collection of data and statistics, methodologies, classifications, microsimulations, indicators, knowledge brokering and benchmark exercises; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i)

Surveys, studies, collection of data and statistics, methodologies, classifications, microsimulations, indicators, knowledge brokering and benchmark exercises;

| (i) | Surveys, studies, collection of
  comparable
  data and statistics,
  where relevant including disaggregated data by gender and age,
  methodologies, classifications, microsimulations
  , pilot studies
  , indicators, knowledge brokering and benchmark exercises; |
| --- | --- |

(i)

Surveys, studies, collection of
  comparable
  data and statistics,
  where relevant including disaggregated data by gender and age,
  methodologies, classifications, microsimulations
  , pilot studies
  , indicators, knowledge brokering and benchmark exercises;

comparable

where relevant including disaggregated data by gender and age,

, pilot studies

Amendment 111

Amendment 111

Proposal for a regulation

Proposal for a regulation

Annex I — point c — point iii

Annex I — point c — point iii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (iii) | Expert groups and panels providing advice, data and information to support health policy development and implementation; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii)

Expert groups and panels providing advice, data and information to support health policy development and implementation;

| (iii) | Expert groups and panels
  , including representatives of relevant stakeholders where applicable,
  providing advice
  , evaluation
  , data and information to support health policy development and implementation
  , including follow-up evaluations of the implementation of health policies
  ; |
| --- | --- |

(iii)

Expert groups and panels
  , including representatives of relevant stakeholders where applicable,
  providing advice
  , evaluation
  , data and information to support health policy development and implementation
  , including follow-up evaluations of the implementation of health policies
  ;

, including representatives of relevant stakeholders where applicable,

, evaluation

, including follow-up evaluations of the implementation of health policies

Amendment 112

Amendment 112

Proposal for a regulation

Proposal for a regulation

Annex I — point c — point iv

Annex I — point c — point iv

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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’. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(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’.

| (iv) | Studies and analysis,
  systematic health impact assessment of other Union policy actions
  and scientific advice to support
  evidence-based
  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’
  . |
| --- | --- |

(iv)

Studies and analysis,
  systematic health impact assessment of other Union policy actions
  and scientific advice to support
  evidence-based
  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’
  .

systematic health impact assessment of other Union policy actions

evidence-based

, as well as the expert group on ‘Health Systems Performance Assessment’

Amendment 113

Amendment 113

Proposal for a regulation

Proposal for a regulation

Annex I — point d — introductory part

Annex I — point d — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| (d) | Development
  and
  implementation of Union health legislation and action, in particular through support to: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(d)

Development
  and
  implementation of Union health legislation and action, in particular through support to:

and

| (d) | Development, implementation
  , and evaluation,
  of Union health legislation and action, in particular through support to: |
| --- | --- |

(d)

Development, implementation
  , and evaluation,
  of Union health legislation and action, in particular through support to:

, and evaluation,

Amendment 114

Amendment 114

Proposal for a regulation

Proposal for a regulation

Annex I — point d — point i

Annex I — point d — point i

| Text proposed by the Commission | Amendment |
| --- | --- |
| (i) | Implementation, enforcement, monitoring of Union health legislation and action; and technical support to the implementation of legal requirements; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i)

Implementation, enforcement, monitoring of Union health legislation and action; and technical support to the implementation of legal requirements;

| (i) | Implementation, enforcement, monitoring of Union health legislation and action
  , including promotion of health
  ; and technical support to the
  full
  implementation of legal
  and operational
  requirements
  throughout Member States
  ; |
| --- | --- |

(i)

Implementation, enforcement, monitoring of Union health legislation and action
  , including promotion of health
  ; and technical support to the
  full
  implementation of legal
  and operational
  requirements
  throughout Member States
  ;

, including promotion of health

full

and operational

throughout Member States

Amendment 115

Amendment 115

Proposal for a regulation

Proposal for a regulation

Annex I — point d — point iv

Annex I — point d — point iv

| Text proposed by the Commission | Amendment |
| --- | --- |
| (iv) | Development
  and
  operation of databases and digital tools and their interoperability, including where appropriate with other sensing technologies, such as space-based; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iv)

Development
  and
  operation of databases and digital tools and their interoperability, including where appropriate with other sensing technologies, such as space-based;

and

| (iv) | Development, operation
  and maintenance
  of databases and digital tools and their interoperability, including
  already established projects,
  where appropriate with other sensing technologies, such as space-based
  and artificial intelligence
  ; |
| --- | --- |

(iv)

Development, operation
  and maintenance
  of databases and digital tools and their interoperability, including
  already established projects,
  where appropriate with other sensing technologies, such as space-based
  and artificial intelligence
  ;

and maintenance

already established projects,

and artificial intelligence

Amendment 116

Amendment 116

Proposal for a regulation

Proposal for a regulation

Annex I — point d — point v

Annex I — point d — point v

| Text proposed by the Commission | Amendment |
| --- | --- |
| (v) | Auditing
  and
  assessment work in accordance with Union legislation; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(v)

Auditing
  and
  assessment work in accordance with Union legislation;

and

| (v) | Auditing, assessment
  and inspection
  work in accordance with Union legislation; |
| --- | --- |

(v)

Auditing, assessment
  and inspection
  work in accordance with Union legislation;

and inspection

Amendment 117

Amendment 117

Proposal for a regulation

Proposal for a regulation

Annex I — point d — point x

Annex I — point d — point x

| Text proposed by the Commission | Amendment |
| --- | --- |
| (x) | National contact points providing guidance, information and assistance related
  the
  implementation of Union health legislation and of the Programme; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(x)

National contact points providing guidance, information and assistance related
  the
  implementation of Union health legislation and of the Programme;

the

| (x) | National contact points providing guidance, information and assistance related
  to the promotion and
  implementation of Union health legislation and of the Programme; |
| --- | --- |

(x)

National contact points providing guidance, information and assistance related
  to the promotion and
  implementation of Union health legislation and of the Programme;

to the promotion and

Amendment 118

Amendment 118

Proposal for a regulation

Proposal for a regulation

Annex I — point d — point xi

Annex I — point d — point xi

| Text proposed by the Commission | Amendment |
| --- | --- |
| (xi) | Stakeholders in view of transnational cooperation. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(xi)

Stakeholders in view of transnational cooperation.

| (xi) | Stakeholders in view of transnational
  and regional
  cooperation. |
| --- | --- |

(xi)

Stakeholders in view of transnational
  and regional
  cooperation.

and regional

Amendment 119

Amendment 119

Proposal for a regulation

Proposal for a regulation

Annex I — point e

Annex I — point e

| Text proposed by the Commission | Amendment |
| --- | --- |
| (e) | Structural stockpile and crisis preparation: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(e)

(e)

Structural stockpile and crisis preparation:

Structural stockpile and crisis preparation:

deleted

deleted

| | (i) | Establishment and support of a mechanism to develop, procure and manage crisis relevant products; |
| --- | --- | --- |

(i)

(i)

Establishment and support of a mechanism to develop, procure and manage crisis relevant products;

Establishment and support of a mechanism to develop, procure and manage crisis relevant products;

| (ii) | Establishment and management of EU reserves and stockpiles of crisis relevant products in complementarity with other Union instruments; |
| --- | --- |

(ii)

(ii)

Establishment and management of EU reserves and stockpiles of crisis relevant products in complementarity with other Union instruments;

Establishment and management of EU reserves and stockpiles of crisis relevant products in complementarity with other Union instruments;

| (iii) | Establishment and support of mechanisms for the efficient monitoring and allocation of available care facilities (such as hospital beds and places in ICUs), for the distribution or allocation of goods and services needed in the case of a health crisis, and to ensure the supply and safe use of medicines, investigational medicines and medical devices; |
| --- | --- |

(iii)

(iii)

Establishment and support of mechanisms for the efficient monitoring and allocation of available care facilities (such as hospital beds and places in ICUs), for the distribution or allocation of goods and services needed in the case of a health crisis, and to ensure the supply and safe use of medicines, investigational medicines and medical devices;

Establishment and support of mechanisms for the efficient monitoring and allocation of available care facilities (such as hospital beds and places in ICUs), for the distribution or allocation of goods and services needed in the case of a health crisis, and to ensure the supply and safe use of medicines, investigational medicines and medical devices;

| (iv) | Procurement of goods and services necessary for the prevention and management of health crises and action to secure access to those essential goods and services; |
| --- | --- |

(iv)

(iv)

Procurement of goods and services necessary for the prevention and management of health crises and action to secure access to those essential goods and services;

Procurement of goods and services necessary for the prevention and management of health crises and action to secure access to those essential goods and services;

| (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; 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; |
| --- | --- |

(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; 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;

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; 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 227

Amendment 227

Proposal for a regulation

Proposal for a regulation

Annex I — point f — point i

Annex I — point f — point i

| Text proposed by the Commission | Amendment |
| --- | --- |
| (i) | Actions to foster Union-wide and cross-sectoral health crisis prevention, preparedness, management and response capacity of actors at Union, national, regional and local level, including contingency planning and preparedness exercises and the upskilling of medical, healthcare and public health staff; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i)

Actions to foster Union-wide and cross-sectoral health crisis prevention, preparedness, management and response capacity of actors at Union, national, regional and local level, including contingency planning and preparedness exercises and the upskilling of medical, healthcare and public health staff;

| (i) | Actions to foster Union-wide and cross-sectoral health crisis prevention, preparedness, management and
  the
  response capacity of actors at Union, national, regional and local level, including
  stress tests,
  contingency planning and preparedness exercises
  , development of quality healthcare standards
  and the upskilling of medical, healthcare and public health staff; |
| --- | --- |

(i)

Actions to foster Union-wide and cross-sectoral health crisis prevention, preparedness, management and
  the
  response capacity of actors at Union, national, regional and local level, including
  stress tests,
  contingency planning and preparedness exercises
  , development of quality healthcare standards
  and the upskilling of medical, healthcare and public health staff;

the

stress tests,

, development of quality healthcare standards

Amendment 121

Amendment 121

Proposal for a regulation

Proposal for a regulation

Annex I — point f — point i a (new)

Annex I — point f — point i a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (i a) | Establishment of a European Health Response Mechanism (EHRM) to respond to all types of health treats and crises and to strengthen operational coordination at European level, coordinated by ECDC with the assistance of relevant agencies; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i a)

(i a)

Establishment of a European Health Response Mechanism (EHRM) to respond to all types of health treats and crises and to strengthen operational coordination at European level, coordinated by ECDC with the assistance of relevant agencies;

Establishment of a European Health Response Mechanism (EHRM) to respond to all types of health treats and crises and to strengthen operational coordination at European level, coordinated by ECDC with the assistance of relevant agencies;

Amendment 251

Amendment 251

Proposal for a regulation

Proposal for a regulation

Annex I — point f — point i b (new)

Annex I — point f — point i b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ib) | Contribute to the establishment of the reserve of health crisis relevant products in complementarity with rescEU, the Emergency Support Instrument, the Resilience Instrument and other Union instruments, programmes and funds, and ensure the availability of such products in times of crisis; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ib)

(ib)

Contribute to the establishment of the reserve of health crisis relevant products in complementarity with rescEU, the Emergency Support Instrument, the Resilience Instrument and other Union instruments, programmes and funds, and ensure the availability of such products in times of crisis;

Contribute to the establishment of the reserve of health crisis relevant products in complementarity with rescEU, the Emergency Support Instrument, the Resilience Instrument and other Union instruments, programmes and funds, and ensure the availability of such products in times of crisis;

Amendment 122

Amendment 122

Proposal for a regulation

Proposal for a regulation

Annex I — point f — point iii

Annex I — point f — point iii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(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;

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;

deleted

deleted

Amendment 123

Amendment 123

Proposal for a regulation

Proposal for a regulation

Annex I — point f — point iv

Annex I — point f — point iv

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(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;

| (iv) | Preventive actions to protect
  all citizens, in particular
  vulnerable groups from health threats and actions to adjust the response to and management of crisis to the needs of those vulnerable groups
  , such as securing basic care for chronic disease patients in need of palliative care and pain management treatment
  ; |
| --- | --- |

(iv)

Preventive actions to protect
  all citizens, in particular
  vulnerable groups from health threats and actions to adjust the response to and management of crisis to the needs of those vulnerable groups
  , such as securing basic care for chronic disease patients in need of palliative care and pain management treatment
  ;

all citizens, in particular

, such as securing basic care for chronic disease patients in need of palliative care and pain management treatment

Amendment 124

Amendment 124

Proposal for a regulation

Proposal for a regulation

Annex I — point f — point iv a (new)

Annex I — point f — point iv a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (iv a) | Actions to support e-health, such as the transition to telemedicine, at-home administration of medication and implementation of preventative / self-care plans, where possible and appropriate; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iv a)

(iv a)

Actions to support e-health, such as the transition to telemedicine, at-home administration of medication and implementation of preventative / self-care plans, where possible and appropriate;

Actions to support e-health, such as the transition to telemedicine, at-home administration of medication and implementation of preventative / self-care plans, where possible and appropriate;

Amendment 125

Amendment 125

Proposal for a regulation

Proposal for a regulation

Annex I — point f — point iv b (new)

Annex I — point f — point iv b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (iv b) | Actions to support cross-border cooperation to ensure access to rapid treatment for all patients across the Union, particularly for those who suffer from a rare disease; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iv b)

(iv b)

Actions to support cross-border cooperation to ensure access to rapid treatment for all patients across the Union, particularly for those who suffer from a rare disease;

Actions to support cross-border cooperation to ensure access to rapid treatment for all patients across the Union, particularly for those who suffer from a rare disease;

Amendment 126

Amendment 126

Proposal for a regulation

Proposal for a regulation

Annex I — point f — point v

Annex I — point f — point v

| Text proposed by the Commission | Amendment |
| --- | --- |
| (v) | Actions to address the collateral health consequences of a health crisis, in particular those on mental health, on patients suffering from chronic diseases and other vulnerable
  groups
  ; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(v)

Actions to address the collateral health consequences of a health crisis, in particular those on mental health, on patients suffering from chronic diseases and other vulnerable
  groups
  ;

groups

| (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
  situations, including people living with addiction, with HIV/AIDS, or suffering from tuberculosis
  ; |
| --- | --- |

(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
  situations, including people living with addiction, with HIV/AIDS, or suffering from tuberculosis
  ;

and manage

situations, including people living with addiction, with HIV/AIDS, or suffering from tuberculosis

Amendment 127

Amendment 127

Proposal for a regulation

Proposal for a regulation

Annex I — point f — point viii a (new)

Annex I — point f — point viii a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(viii a)

(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;

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 128

Amendment 128

Proposal for a regulation

Proposal for a regulation

Annex I — point f — point viii b (new)

Annex I — point f — point viii b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (viii b) | Actions to ensure that access to medicines is undisrupted, and that there is continuity of care and treatment, in particular for patients suffering from chronic conditions; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(viii b)

(viii b)

Actions to ensure that access to medicines is undisrupted, and that there is continuity of care and treatment, in particular for patients suffering from chronic conditions;

Actions to ensure that access to medicines is undisrupted, and that there is continuity of care and treatment, in particular for patients suffering from chronic conditions;

Amendment 129

Amendment 129

Proposal for a regulation

Proposal for a regulation

Annex I — point g — introductory part

Annex I — point g — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| (g) | Strengthen national health systems: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(g)

Strengthen national health systems:

| (g) | Strengthen national health systems
  , promote and protect health and prevent diseases
  : |
| --- | --- |

(g)

Strengthen national health systems
  , promote and protect health and prevent diseases
  :

, promote and protect health and prevent diseases

Amendment 130

Amendment 130

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point i

Annex I — point g — point i

| Text proposed by the Commission | Amendment |
| --- | --- |
| (i) | Support knowledge transfer actions and Union level cooperation to assist national reform processes towards improved effectiveness, accessibility, sustainability and resilience, in particular to address the challenges identified by the European Semester and to strengthen primary care, reinforce the integration of care and aim at universal health coverage and equal access to healthcare; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i)

Support knowledge transfer actions and Union level cooperation to assist national reform processes towards improved effectiveness, accessibility, sustainability and resilience, in particular to address the challenges identified by the European Semester and to strengthen primary care, reinforce the integration of care and aim at universal health coverage and equal access to healthcare;

| (i) | Support knowledge transfer actions and Union level cooperation to assist national reform processes towards improved effectiveness, accessibility, sustainability and resilience,
  while linking available Union 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, aim at universal health coverage and
  reach
  equal access to
  good quality
  healthcare; |
| --- | --- |

(i)

Support knowledge transfer actions and Union level cooperation to assist national reform processes towards improved effectiveness, accessibility, sustainability and resilience,
  while linking available Union 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, aim at universal health coverage and
  reach
  equal access to
  good quality
  healthcare;

while linking available Union funding,

and Country Specific Recommendations on health,

reach

good quality

Amendment 131

Amendment 131

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point i a (new)

Annex I — point g — point i a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (i a) | Support implementing policies and actions to reduce health inequalities and inequities in relation to healthcare; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i a)

(i a)

Support implementing policies and actions to reduce health inequalities and inequities in relation to healthcare;

Support implementing policies and actions to reduce health inequalities and inequities in relation to healthcare;

Amendment 132

Amendment 132

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point ii

Annex I — point g — point ii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (ii) | Training programmes for medical and healthcare staff, and programmes for temporary exchanges of staff; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ii)

Training programmes for medical and healthcare staff, and programmes for temporary exchanges of staff;

| (ii) | Support in synergy with other Programmes
  training
  , educational and mobility
  programmes for medical and healthcare staff
  , including online programmes
  , and programmes for temporary exchanges of staff
  , in particular with the aim of improving their curricula and digital skills
  ; |
| --- | --- |

(ii)

Support in synergy with other Programmes
  training
  , educational and mobility
  programmes for medical and healthcare staff
  , including online programmes
  , and programmes for temporary exchanges of staff
  , in particular with the aim of improving their curricula and digital skills
  ;

Support in synergy with other Programmes

, educational and mobility

, including online programmes

, in particular with the aim of improving their curricula and digital skills

Amendment 133

Amendment 133

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point iii

Annex I — point g — point iii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (iii) | Support to improve the geographical distribution of healthcare workforce
  and avoidance of
  ‘medical deserts’; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii)

Support to improve the geographical distribution of healthcare workforce
  and avoidance of
  ‘medical deserts’;

and avoidance of

| (iii) | Support
  in synergy with other Programmes
  to improve the geographical distribution of
  the
  healthcare workforce
  , while ensuring that such distribution of the workforce is also proportionate to the population of the area or region in question, and thus avoiding
  ‘medical deserts’
  and promote and implement retention policies
  ; |
| --- | --- |

(iii)

Support
  in synergy with other Programmes
  to improve the geographical distribution of
  the
  healthcare workforce
  , while ensuring that such distribution of the workforce is also proportionate to the population of the area or region in question, and thus avoiding
  ‘medical deserts’
  and promote and implement retention policies
  ;

in synergy with other Programmes

the

, while ensuring that such distribution of the workforce is also proportionate to the population of the area or region in question, and thus avoiding

and promote and implement retention policies

Amendment 134

Amendment 134

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point iv

Annex I — point g — point iv

| Text proposed by the Commission | Amendment |
| --- | --- |
| (iv) | Support the establishment
  and
  coordination of Union Reference Laboratories and Centres,
  and of
  Centres of excellence; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iv)

Support the establishment
  and
  coordination of Union Reference Laboratories and Centres,
  and of
  Centres of excellence;

and

and of

| (iv) | Support the establishment, coordination
  and deployment
  of Union Reference Laboratories and Centres, Centres of Excellence
  and EU disease-specific platforms for the exchange, comparison and benchmarking of best practices between Member States
  ; |
| --- | --- |

(iv)

Support the establishment, coordination
  and deployment
  of Union Reference Laboratories and Centres, Centres of Excellence
  and EU disease-specific platforms for the exchange, comparison and benchmarking of best practices between Member States
  ;

and deployment

and EU disease-specific platforms for the exchange, comparison and benchmarking of best practices between Member States

Amendment 135

Amendment 135

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point v

Annex I — point g — point v

| Text proposed by the Commission | Amendment |
| --- | --- |
| (v) | Audit of Member States preparedness and response arrangements (such as crisis management, antimicrobial resistance, vaccination); |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(v)

Audit of Member States preparedness and response arrangements (such as crisis management, antimicrobial resistance, vaccination);

| (v) | Audit of Member States preparedness and response arrangements (such as crisis management, antimicrobial resistance, vaccination)
  and the implementation of their health promotion and disease prevention national strategies or programmes
  ; |
| --- | --- |

(v)

Audit of Member States preparedness and response arrangements (such as crisis management, antimicrobial resistance, vaccination)
  and the implementation of their health promotion and disease prevention national strategies or programmes
  ;

and the implementation of their health promotion and disease prevention national strategies or programmes

Amendment 136

Amendment 136

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point viii a (new)

Annex I — point g — point viii a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (viii a) | Support a Union framework and the related interoperable digital tools to strengthen health technology assessment cooperation among Member States and in networks, including networks needed in order to enable Member States to deliver and exchange timely, reliable and high quality joint clinical assessments, and joint scientific consultations and other relevant activities to support decision-makers to exchange outcomes of cooperation regarding HTA; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(viii a)

(viii a)

Support a Union framework and the related interoperable digital tools to strengthen health technology assessment cooperation among Member States and in networks, including networks needed in order to enable Member States to deliver and exchange timely, reliable and high quality joint clinical assessments, and joint scientific consultations and other relevant activities to support decision-makers to exchange outcomes of cooperation regarding HTA;

Support a Union framework and the related interoperable digital tools to strengthen health technology assessment cooperation among Member States and in networks, including networks needed in order to enable Member States to deliver and exchange timely, reliable and high quality joint clinical assessments, and joint scientific consultations and other relevant activities to support decision-makers to exchange outcomes of cooperation regarding HTA;

Amendment 137

Amendment 137

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point ix

Annex I — point g — point ix

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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); |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(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);

| (ix) | Support the establishment and implementation of
  national and European
  programmes
  , including 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 health units and communities, and mitigate the main risk factors of chronic diseases
  ; |
| --- | --- |

(ix)

Support the establishment and implementation of
  national and European
  programmes
  , including 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 health units and communities, and mitigate the main risk factors of chronic diseases
  ;

national and European

, including digital and evidence-based programmes,

, health literacy

in health units and communities, and mitigate the main risk factors of chronic diseases

Amendment 138

Amendment 138

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point ix a (new)

Annex I — point g — point ix a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ix a) | Support the establishment and functioning of disease-specific Union platforms for the exchange, comparison and benchmarking of best practices between Member States, in the form of excellence networks in the field of communicable and non-communicable diseases, in particular in the area of chronic diseases; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ix a)

(ix a)

Support the establishment and functioning of disease-specific Union platforms for the exchange, comparison and benchmarking of best practices between Member States, in the form of excellence networks in the field of communicable and non-communicable diseases, in particular in the area of chronic diseases;

Support the establishment and functioning of disease-specific Union platforms for the exchange, comparison and benchmarking of best practices between Member States, in the form of excellence networks in the field of communicable and non-communicable diseases, in particular in the area of chronic diseases;

Amendment 139

Amendment 139

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point ix b (new)

Annex I — point g — point ix b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ix b) | Support the development of guidelines for preventing and managing diseases in the area of both communicable and non-communicable diseases; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ix b)

(ix b)

Support the development of guidelines for preventing and managing diseases in the area of both communicable and non-communicable diseases;

Support the development of guidelines for preventing and managing diseases in the area of both communicable and non-communicable diseases;

Amendment 140

Amendment 140

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point x

Annex I — point g — point x

| Text proposed by the Commission | Amendment |
| --- | --- |
| (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
  ; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(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
  ;

vulnerable groups

| (x) | Support Member States’ actions to put in place healthy and safe urban, work and school environments, to
  promote mental health, health education,
  enable healthy life choices and promote
  regular physical activity and
  healthy diets taking into account the needs of
  people at every stage of their life with the aim of promoting life-long health
  ; |
| --- | --- |

(x)

Support Member States’ actions to put in place healthy and safe urban, work and school environments, to
  promote mental health, health education,
  enable healthy life choices and promote
  regular physical activity and
  healthy diets taking into account the needs of
  people at every stage of their life with the aim of promoting life-long health
  ;

promote mental health, health education,

regular physical activity and

people at every stage of their life with the aim of promoting life-long health

Amendment 141

Amendment 141

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point x a (new)

Annex I — point g — point x a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (x a) | Support Member States actions to address health determinants, including reducing alcohol related harm and tobacco use; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(x a)

(x a)

Support Member States actions to address health determinants, including reducing alcohol related harm and tobacco use;

Support Member States actions to address health determinants, including reducing alcohol related harm and tobacco use;

Amendment 142

Amendment 142

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point x b (new)

Annex I — point g — point x b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (x b) | Support Member States’ actions to ensure access to sexual and reproductive health services and related medicinal products, and support integrated and intersectional approaches to prevention, diagnosis, treatment and care; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(x b)

(x b)

Support Member States’ actions to ensure access to sexual and reproductive health services and related medicinal products, and support integrated and intersectional approaches to prevention, diagnosis, treatment and care;

Support Member States’ actions to ensure access to sexual and reproductive health services and related medicinal products, and support integrated and intersectional approaches to prevention, diagnosis, treatment and care;

Amendment 143

Amendment 143

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point x c (new)

Annex I — point g — point x c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (x c) | Actions promoting care and support for victims of gender-based violence; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(x c)

(x c)

Actions promoting care and support for victims of gender-based violence;

Actions promoting care and support for victims of gender-based violence;

Amendment 144

Amendment 144

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point x d (new)

Annex I — point g — point x d (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (x d) | Actions promoting equal access to health services and related facilities and care for people with disabilities; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(x d)

(x d)

Actions promoting equal access to health services and related facilities and care for people with disabilities;

Actions promoting equal access to health services and related facilities and care for people with disabilities;

Amendment 145

Amendment 145

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point xi a (new)

Annex I — point g — point xi a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (xi a) | Support Member States in the revision of their rare disease national plans to put in place the necessary financial and organisational arrangements to integrate effectively the European Reference Networks system into the national health systems by also supporting the development and implementation of the set of policies, rules and procedures required to anchor the ERN system to the national level; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(xi a)

(xi a)

Support Member States in the revision of their rare disease national plans to put in place the necessary financial and organisational arrangements to integrate effectively the European Reference Networks system into the national health systems by also supporting the development and implementation of the set of policies, rules and procedures required to anchor the ERN system to the national level;

Support Member States in the revision of their rare disease national plans to put in place the necessary financial and organisational arrangements to integrate effectively the European Reference Networks system into the national health systems by also supporting the development and implementation of the set of policies, rules and procedures required to anchor the ERN system to the national level;

Amendment 146

Amendment 146

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point xi b (new)

Annex I — point g — point xi b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (xi b) | Support the implementation of the ERNs’ system for continuous assessment, monitoring, evaluation and quality improvement; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(xi b)

(xi b)

Support the implementation of the ERNs’ system for continuous assessment, monitoring, evaluation and quality improvement;

Support the implementation of the ERNs’ system for continuous assessment, monitoring, evaluation and quality improvement;

Amendment 147

Amendment 147

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point xi c (new)

Annex I — point g — point xi c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (xi c) | Earmark funding to create effective and permanent mechanisms for the collaboration of ERNs to address the multi-systemic needs arising from low prevalence diseases and rare diseases and to facilitate diagonal networking between different specialities and disciplines; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(xi c)

(xi c)

Earmark funding to create effective and permanent mechanisms for the collaboration of ERNs to address the multi-systemic needs arising from low prevalence diseases and rare diseases and to facilitate diagonal networking between different specialities and disciplines;

Earmark funding to create effective and permanent mechanisms for the collaboration of ERNs to address the multi-systemic needs arising from low prevalence diseases and rare diseases and to facilitate diagonal networking between different specialities and disciplines;

Amendment 148

Amendment 148

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point xi d (new)

Annex I — point g — point xi d (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (xi d) | Support Member States in strengthening their Centres of Expertise for rare diseases to increase the capacities of national health systems to diagnose, treat and manage such diseases, transnational cooperation on codification, information and knowledge in the field of rare diseases, in particular the Orphanet database; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(xi d)

(xi d)

Support Member States in strengthening their Centres of Expertise for rare diseases to increase the capacities of national health systems to diagnose, treat and manage such diseases, transnational cooperation on codification, information and knowledge in the field of rare diseases, in particular the Orphanet database;

Support Member States in strengthening their Centres of Expertise for rare diseases to increase the capacities of national health systems to diagnose, treat and manage such diseases, transnational cooperation on codification, information and knowledge in the field of rare diseases, in particular the Orphanet database;

Amendment 149

Amendment 149

Proposal for a regulation

Proposal for a regulation

Annex I — point g — point xii a (new)

Annex I — point g — point xii a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (xii a) | 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(xii a)

(xii a)

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;

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 150

Amendment 150

Proposal for a regulation

Proposal for a regulation

Annex I — point h — introductory part

Annex I — point h — introductory part

| Text proposed by the Commission | Amendment |
| --- | --- |
| (h) | Actions on cancer: |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(h)

Actions on cancer:

| (h) | Actions on cancer
  , including paediatric cancer
  : |
| --- | --- |

(h)

Actions on cancer
  , including paediatric cancer
  :

, including paediatric cancer

Amendment 151

Amendment 151

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point i

Annex I — point h — point i

| Text proposed by the Commission | Amendment |
| --- | --- |
| (i) | Support Member States and NGOs in the promotion and
  implemention
  of the recommendations of the European Code against Cancer; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i)

Support Member States and NGOs in the promotion and
  implemention
  of the recommendations of the European Code against Cancer;

implemention

| (i) | Support Member States
  , IARC
  and NGOs in the promotion and
  implementation
  of the recommendations of the European Code against Cancer;
  support the revision and continuous update of the current edition of the European Code against Cancer; |
| --- | --- |

(i)

Support Member States
  , IARC
  and NGOs in the promotion and
  implementation
  of the recommendations of the European Code against Cancer;
  support the revision and continuous update of the current edition of the European Code against Cancer;

, IARC

implementation

support the revision and continuous update of the current edition of the European Code against Cancer;

Amendment 152

Amendment 152

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point i a (new)

Annex I — point h — point i a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (i a) | Support the establishment of a European Cancer Institute (ECI) as a platform for the implementation of the European Reference Cancer Networks, the collection of clinical data among centres from all participating countries across the Union and the prioritisation of academic and clinical research programmes of excellence in the area of cancer including paediatric cancer; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i a)

(i a)

Support the establishment of a European Cancer Institute (ECI) as a platform for the implementation of the European Reference Cancer Networks, the collection of clinical data among centres from all participating countries across the Union and the prioritisation of academic and clinical research programmes of excellence in the area of cancer including paediatric cancer;

Support the establishment of a European Cancer Institute (ECI) as a platform for the implementation of the European Reference Cancer Networks, the collection of clinical data among centres from all participating countries across the Union and the prioritisation of academic and clinical research programmes of excellence in the area of cancer including paediatric cancer;

Amendment 153

Amendment 153

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point iii

Annex I — point h — point iii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (iii) | Support prevention programmes on the main cancer risk factors; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii)

Support prevention programmes on the main cancer risk factors;

| (iii) | Support prevention programmes on the main cancer risk factors
  that are of demonstrated effectiveness and supported by established evidence
  ; |
| --- | --- |

(iii)

Support prevention programmes on the main cancer risk factors
  that are of demonstrated effectiveness and supported by established evidence
  ;

that are of demonstrated effectiveness and supported by established evidence

Amendment 154

Amendment 154

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point iv a (new)

Annex I — point h — point iv a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (iv a) | Action to support the implementation of cancer registries in all Member States; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iv a)

(iv a)

Action to support the implementation of cancer registries in all Member States;

Action to support the implementation of cancer registries in all Member States;

Amendment 155

Amendment 155

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point v

Annex I — point h — point v

| Text proposed by the Commission | Amendment |
| --- | --- |
| (v) | Actions supporting access to cancer services and to innovative medicines for cancer; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(v)

Actions supporting access to cancer services and to innovative medicines for cancer;

| (v) | Actions supporting
  implementing policies, national programmes and guidelines, in line with the Europe’s Beating Cancer plan, to reduce inequalities and grant
  access to cancer services
  , supportive and palliative care,
  and to innovative
  , accessible and effective screening, treatments and
  medicines for cancer
  across all Member States, in full synergy with Horizon Europe and its missions and partnerships
  ; |
| --- | --- |

(v)

Actions supporting
  implementing policies, national programmes and guidelines, in line with the Europe’s Beating Cancer plan, to reduce inequalities and grant
  access to cancer services
  , supportive and palliative care,
  and to innovative
  , accessible and effective screening, treatments and
  medicines for cancer
  across all Member States, in full synergy with Horizon Europe and its missions and partnerships
  ;

implementing policies, national programmes and guidelines, in line with the Europe’s Beating Cancer plan, to reduce inequalities and grant

, supportive and palliative care,

, accessible and effective screening, treatments and

across all Member States, in full synergy with Horizon Europe and its missions and partnerships

Amendment 156

Amendment 156

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point v a (new)

Annex I — point h — point v a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (v a) | Actions supporting equal and timely access to new and innovative medicines and therapies, including for supportive and palliative care, for paediatric malignancies, across Europe, and foster the availability and affordability of such medicines and treatments in child-friendly doses and formulations; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(v a)

(v a)

Actions supporting equal and timely access to new and innovative medicines and therapies, including for supportive and palliative care, for paediatric malignancies, across Europe, and foster the availability and affordability of such medicines and treatments in child-friendly doses and formulations;

Actions supporting equal and timely access to new and innovative medicines and therapies, including for supportive and palliative care, for paediatric malignancies, across Europe, and foster the availability and affordability of such medicines and treatments in child-friendly doses and formulations;

Amendment 157

Amendment 157

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point v b (new)

Annex I — point h — point v b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (v b) | Actions to address the unmet needs of children and adolescents with cancer, and of survivors of cancer, through dedicated programmes and plans that will enable the ERN, including those on paediatric cancer; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(v b)

(v b)

Actions to address the unmet needs of children and adolescents with cancer, and of survivors of cancer, through dedicated programmes and plans that will enable the ERN, including those on paediatric cancer;

Actions to address the unmet needs of children and adolescents with cancer, and of survivors of cancer, through dedicated programmes and plans that will enable the ERN, including those on paediatric cancer;

Amendment 158

Amendment 158

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point vii

Annex I — point h — point vii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (vii) | Actions supporting quality in cancer prevention and care including diagnosis and treatment; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(vii)

Actions supporting quality in cancer prevention and care including diagnosis and treatment;

| (vii) | Actions supporting quality in cancer prevention and care including diagnosis and treatment
  , follow-up, and supportive and palliative care
  ; |
| --- | --- |

(vii)

Actions supporting quality in cancer prevention and care including diagnosis and treatment
  , follow-up, and supportive and palliative care
  ;

, follow-up, and supportive and palliative care

Amendment 159

Amendment 159

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point viii

Annex I — point h — point viii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (viii) | Actions supporting the quality of life of cancer survivors and care givers; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(viii)

Actions supporting the quality of life of cancer survivors and care givers;

| (viii) | Actions supporting the quality of life of cancer survivors and care givers
  , including provision of psychological support, pain management, and professional re-integration
  ; |
| --- | --- |

(viii)

Actions supporting the quality of life of cancer survivors and care givers
  , including provision of psychological support, pain management, and professional re-integration
  ;

, including provision of psychological support, pain management, and professional re-integration

Amendment 160

Amendment 160

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point ix

Annex I — point h — point ix

| Text proposed by the Commission | Amendment |
| --- | --- |
| (ix) | Support to the implementation of the Union’s tobacco control policy and legislation; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ix)

Support to the implementation of the Union’s tobacco control policy and legislation;

| (ix) | Support to the implementation of the Union’s tobacco control policy and legislation
  and other related legislation in the area of prevention and health promotion, including aimed at reducing alcohol related harm
  ; |
| --- | --- |

(ix)

Support to the implementation of the Union’s tobacco control policy and legislation
  and other related legislation in the area of prevention and health promotion, including aimed at reducing alcohol related harm
  ;

and other related legislation in the area of prevention and health promotion, including aimed at reducing alcohol related harm

Amendment 161

Amendment 161

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point x

Annex I — point h — point x

| Text proposed by the Commission | Amendment |
| --- | --- |
| (x) | Establishment and support of a mechanisms for cross-specialty capacity building and continuous education in the area of cancer care. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(x)

Establishment and support of a mechanisms for cross-specialty capacity building and continuous education in the area of cancer care.

| (x) | Establishment and support of a mechanisms for cross-specialty capacity building and continuous education
  of healthcare professionals and informal carers
  in the area of cancer care
  , screening and early diagnosis, in particular in the area of paediatric cancer, with the aim to improve the quality of care; |
| --- | --- |

(x)

Establishment and support of a mechanisms for cross-specialty capacity building and continuous education
  of healthcare professionals and informal carers
  in the area of cancer care
  , screening and early diagnosis, in particular in the area of paediatric cancer, with the aim to improve the quality of care;

of healthcare professionals and informal carers

, screening and early diagnosis, in particular in the area of paediatric cancer, with the aim to improve the quality of care;

Amendment 162

Amendment 162

Proposal for a regulation

Proposal for a regulation

Annex I — point h — point x a (new)

Annex I — point h — point x a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (x a) | Actions to support an integrative, coordinated, multi-disciplinary and patient-centred approach concerning cancer patients and survivors; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(x a)

(x a)

Actions to support an integrative, coordinated, multi-disciplinary and patient-centred approach concerning cancer patients and survivors;

Actions to support an integrative, coordinated, multi-disciplinary and patient-centred approach concerning cancer patients and survivors;

Amendment 163

Amendment 163

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point ii

Annex I — point i — point ii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (ii) | Support actions to fight vaccine hesitancy; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ii)

Support actions to fight vaccine hesitancy;

| (ii) | Support actions to fight vaccine hesitancy
  and disinformation, and promote immunization throughout all stages of a person’s lifetime
  ; |
| --- | --- |

(ii)

Support actions to fight vaccine hesitancy
  and disinformation, and promote immunization throughout all stages of a person’s lifetime
  ;

and disinformation, and promote immunization throughout all stages of a person’s lifetime

Amendment 164

Amendment 164

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point ii a (new)

Annex I — point i — point ii a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ii a) | Support tools and platforms to collect real-world evidence on the safety, effectiveness and impact of vaccines after use, without prejudice to the generation of robust evidence in the pre-approval phase; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ii a)

(ii a)

Support tools and platforms to collect real-world evidence on the safety, effectiveness and impact of vaccines after use, without prejudice to the generation of robust evidence in the pre-approval phase;

Support tools and platforms to collect real-world evidence on the safety, effectiveness and impact of vaccines after use, without prejudice to the generation of robust evidence in the pre-approval phase;

Amendment 165

Amendment 165

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point ii b (new)

Annex I — point i — point ii b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (ii b) | support action for the elimination of vaccine preventable diseases; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ii b)

(ii b)

support action for the elimination of vaccine preventable diseases;

support action for the elimination of vaccine preventable diseases;

Amendment 166

Amendment 166

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point iii

Annex I — point i — point iii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (iii) | Support clinical trials to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii)

Support clinical trials to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines;

| (iii) | Support clinical trials
  and the use of real world data, 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; |
| --- | --- |

(iii)

Support clinical trials
  and the use of real world data, 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;

and the use of real world data, including those involving increased coordination at Union level and with EMA,

Amendment 167

Amendment 167

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point iii a (new)

Annex I — point i — point iii a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (iii a) | Support actions aimed at creating and developing a European digital mechanism for better reporting, notification and monitoring of potential shortages, in the form of a Union platform for shortages of medicines, vaccines and medical devices, based on one harmonised and interoperable data-collection model and national reporting systems for shortages, including the full implementation of an effective Union telematics infrastructure that will link data on medicines and supply chains; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii a)

(iii a)

Support actions aimed at creating and developing a European digital mechanism for better reporting, notification and monitoring of potential shortages, in the form of a Union platform for shortages of medicines, vaccines and medical devices, based on one harmonised and interoperable data-collection model and national reporting systems for shortages, including the full implementation of an effective Union telematics infrastructure that will link data on medicines and supply chains;

Support actions aimed at creating and developing a European digital mechanism for better reporting, notification and monitoring of potential shortages, in the form of a Union platform for shortages of medicines, vaccines and medical devices, based on one harmonised and interoperable data-collection model and national reporting systems for shortages, including the full implementation of an effective Union telematics infrastructure that will link data on medicines and supply chains;

Amendment 168

Amendment 168

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point iii b (new)

Annex I — point i — point iii b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (iii b) | Support actions aimed at stimulating the increase in the production of essential APIs and medicinal products in the Union, including by diversifying supply chain production of active ingredients and generics within the Union to reduce the Member States’ dependence on certain third countries; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii b)

(iii b)

Support actions aimed at stimulating the increase in the production of essential APIs and medicinal products in the Union, including by diversifying supply chain production of active ingredients and generics within the Union to reduce the Member States’ dependence on certain third countries;

Support actions aimed at stimulating the increase in the production of essential APIs and medicinal products in the Union, including by diversifying supply chain production of active ingredients and generics within the Union to reduce the Member States’ dependence on certain third countries;

Amendment 169

Amendment 169

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point iv

Annex I — point i — point iv

| Text proposed by the Commission | Amendment |
| --- | --- |
| (iv) | Support action to ensure greater availability in the Union of
  medicines
  and medical devices and contribute to their affordability for patients and health systems; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iv)

Support action to ensure greater availability in the Union of
  medicines
  and medical devices and contribute to their affordability for patients and health systems;

medicines

| (iv) | Support action to ensure greater availability in the Union of
  medicinal products
  and medical devices and contribute to their affordability for patients and health systems; |
| --- | --- |

(iv)

Support action to ensure greater availability in the Union of
  medicinal products
  and medical devices and contribute to their affordability for patients and health systems;

medicinal products

Amendment 170

Amendment 170

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point v

Annex I — point i — point v

| Text proposed by the Commission | Amendment |
| --- | --- |
| (v) | Support action to encourage the
  develoment
  of innovative
  products and of less commercially interesting products such as antimicrobials
  ; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(v)

Support action to encourage the
  develoment
  of innovative
  products and of less commercially interesting products such as antimicrobials
  ;

develoment

products and of less commercially interesting products such as antimicrobials

| (v) | Support action to encourage the
  discovery and development
  of innovative
  medicines and vaccines to meet rising healthcare challenges and patients’ needs
  ; |
| --- | --- |

(v)

Support action to encourage the
  discovery and development
  of innovative
  medicines and vaccines to meet rising healthcare challenges and patients’ needs
  ;

discovery and development

medicines and vaccines to meet rising healthcare challenges and patients’ needs

Amendment 171

Amendment 171

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point v a (new)

Annex I — point i — point v a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (v a) | Support actions to foster innovation in repurposing, reformulation and combining of off-patent medicines that deliver relevant improvements for patients, healthcare professionals and healthcare systems; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(v a)

(v a)

Support actions to foster innovation in repurposing, reformulation and combining of off-patent medicines that deliver relevant improvements for patients, healthcare professionals and healthcare systems;

Support actions to foster innovation in repurposing, reformulation and combining of off-patent medicines that deliver relevant improvements for patients, healthcare professionals and healthcare systems;

Amendment 172

Amendment 172

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point v b (new)

Annex I — point i — point v b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (v b) | Action to address market failures with regard to antibiotics and encourage sustainable investments for the discovery and development of new antimicrobials, of medicines for rare diseases and of medicines to fight against communicable diseases, while ensuring equitable access; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(v b)

(v b)

Action to address market failures with regard to antibiotics and encourage sustainable investments for the discovery and development of new antimicrobials, of medicines for rare diseases and of medicines to fight against communicable diseases, while ensuring equitable access;

Action to address market failures with regard to antibiotics and encourage sustainable investments for the discovery and development of new antimicrobials, of medicines for rare diseases and of medicines to fight against communicable diseases, while ensuring equitable access;

Amendment 173

Amendment 173

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point vi

Annex I — point i — point vi

| Text proposed by the Commission | Amendment |
| --- | --- |
| (vi) | Support action to monitor shortages of medicines and medical devices occurring in hospitals and community pharmacies, to address such shortages, and to increase security of supplies; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(vi)

Support action to monitor shortages of medicines and medical devices occurring in hospitals and community pharmacies, to address such shortages, and to increase security of supplies;

| (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; |
| --- | --- |

(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;

, prevent, manage, report and notify

collect reported shortages in a centralized database, interoperable with databases that contained regulatory data on medicines, to

Amendment 174

Amendment 174

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point viii

Annex I — point i — point viii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (viii) | Action to strengthen the environmental risk assessment of pharmaceuticals; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(viii)

Action to strengthen the environmental risk assessment of pharmaceuticals;

| (viii) | Action to strengthen the environmental risk assessment of pharmaceuticals
  and medical devices
  ; |
| --- | --- |

(viii)

Action to strengthen the environmental risk assessment of pharmaceuticals
  and medical devices
  ;

and medical devices

Amendment 175

Amendment 175

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point ix

Annex I — point i — point ix

| Text proposed by the Commission | Amendment |
| --- | --- |
| (ix) | Action to promote the prudent use and disposal of antimicrobials; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ix)

Action to promote the prudent use and disposal of antimicrobials;

| (ix) | Action to promote the prudent use and disposal of
  medicines, especially
  antimicrobials
  and to reduce the overall use of medicines, action to support the surveillance of antimicrobial use and to support the fight against antimicrobial resistance (AMR)
  ; |
| --- | --- |

(ix)

Action to promote the prudent use and disposal of
  medicines, especially
  antimicrobials
  and to reduce the overall use of medicines, action to support the surveillance of antimicrobial use and to support the fight against antimicrobial resistance (AMR)
  ;

medicines, especially

and to reduce the overall use of medicines, action to support the surveillance of antimicrobial use and to support the fight against antimicrobial resistance (AMR)

Amendment 176

Amendment 176

Proposal for a regulation

Proposal for a regulation

Annex I — point i — point x

Annex I — point i — point x

| Text proposed by the Commission | Amendment |
| --- | --- |
| (x) | Support action to foster international regulatory
  covergence on medicines
  and medical devices. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(x)

Support action to foster international regulatory
  covergence on medicines
  and medical devices.

covergence on medicines

| (x) | Support action to foster international regulatory
  convergence and reliance on medicinal products
  and medical devices
  , and to improve regulatory oversight by the Union
  . |
| --- | --- |

(x)

Support action to foster international regulatory
  convergence and reliance on medicinal products
  and medical devices
  , and to improve regulatory oversight by the Union
  .

convergence and reliance on medicinal products

, and to improve regulatory oversight by the Union

Amendment 177

Amendment 177

Proposal for a regulation

Proposal for a regulation

Annex I — point j — point i

Annex I — point j — point i

| Text proposed by the Commission | Amendment |
| --- | --- |
| (i) | Support for the deployment, operation and maintenance of mature interoperable digital service infrastructures and data
  quality
  assurance processes for data exchange, access, use and reuse; support for cross border networking, including through
  the
  use of electronic health records, registries and other databases; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i)

Support for the deployment, operation and maintenance of mature interoperable digital service infrastructures and data
  quality
  assurance processes for data exchange, access, use and reuse; support for cross border networking, including through
  the
  use of electronic health records, registries and other databases;

quality

the

| (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
  improvement and better
  use of electronic health records, registries and other databases; |
| --- | --- |

(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
  improvement and better
  use of electronic health records, registries and other databases;

security and

improvement and better

Amendment 178

Amendment 178

Proposal for a regulation

Proposal for a regulation

Annex I — point j — point i a (new)

Annex I — point j — point i a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (i a) | Establish the European Electronic Health Record and support its implementation in the Member States in order to increase the use of e-health and improve the sustainability and resilience of healthcare systems; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i a)

(i a)

Establish the European Electronic Health Record and support its implementation in the Member States in order to increase the use of e-health and improve the sustainability and resilience of healthcare systems;

Establish the European Electronic Health Record and support its implementation in the Member States in order to increase the use of e-health and improve the sustainability and resilience of healthcare systems;

Amendment 179

Amendment 179

Proposal for a regulation

Proposal for a regulation

Annex I — point j — point i b (new)

Annex I — point j — point i b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (i b) | Support Member States to improve and further develop and implement ERN registries; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(i b)

(i b)

Support Member States to improve and further develop and implement ERN registries;

Support Member States to improve and further develop and implement ERN registries;

Amendment 180

Amendment 180

Proposal for a regulation

Proposal for a regulation

Annex I — point j — point ii

Annex I — point j — point ii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (ii) | Support to the digital transformation of health care and health systems including through benchmarking and capacity building for the uptake of innovative tools and technologies; digital upskilling of health care
  professsionals
  ; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(ii)

Support to the digital transformation of health care and health systems including through benchmarking and capacity building for the uptake of innovative tools and technologies; digital upskilling of health care
  professsionals
  ;

professsionals

| (ii) | Support to the digital transformation of health care and health systems including through benchmarking and capacity building for the uptake of innovative tools and technologies
  and strengthening the safe use and re-use of health data, in line with GDPR; support and implement
  digital upskilling of health care
  professionals and citizens, through enhanced education, training and (digital) health literacy measures
  ; |
| --- | --- |

(ii)

Support to the digital transformation of health care and health systems including through benchmarking and capacity building for the uptake of innovative tools and technologies
  and strengthening the safe use and re-use of health data, in line with GDPR; support and implement
  digital upskilling of health care
  professionals and citizens, through enhanced education, training and (digital) health literacy measures
  ;

and strengthening the safe use and re-use of health data, in line with GDPR; support and implement

professionals and citizens, through enhanced education, training and (digital) health literacy measures

Amendment 181

Amendment 181

Proposal for a regulation

Proposal for a regulation

Annex I — point j — point iii

Annex I — point j — point iii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (iii) | Support the deployment 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; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii)

Support the deployment 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;

| (iii) | Support the deployment and interoperability of digital tools and infrastructures within and between Member States and with Union Institutions
  , agencies
  and bodies; develop appropriate governance structures and sustainable, interoperable Union health information systems, as part of the European Health Data Space and with
  a view to having safe and efficient deployment of AI in health care strengthening and facilitating
  citizens’ access to and control over their health data;
  support uptake and broader implementation of current successful initiatives and projects on person-centred digital health and health data; |
| --- | --- |

(iii)

Support the deployment and interoperability of digital tools and infrastructures within and between Member States and with Union Institutions
  , agencies
  and bodies; develop appropriate governance structures and sustainable, interoperable Union health information systems, as part of the European Health Data Space and with
  a view to having safe and efficient deployment of AI in health care strengthening and facilitating
  citizens’ access to and control over their health data;
  support uptake and broader implementation of current successful initiatives and projects on person-centred digital health and health data;

, agencies

a view to having safe and efficient deployment of AI in health care strengthening and facilitating

support uptake and broader implementation of current successful initiatives and projects on person-centred digital health and health data;

Amendment 182

Amendment 182

Proposal for a regulation

Proposal for a regulation

Annex I — point j — point iv

Annex I — point j — point iv

| Text proposed by the Commission | Amendment |
| --- | --- |
| (iv) | Support 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. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iv)

Support 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.

| (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
  ; promote involvement of patients and care professionals in the co-design and co-development of user-friendly, accessible, secure and efficient telemedicine/telehealth and other digital solutions
  . |
| --- | --- |

(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
  ; promote involvement of patients and care professionals in the co-design and co-development of user-friendly, accessible, secure and efficient telemedicine/telehealth and other digital solutions
  .

access to and

; promote involvement of patients and care professionals in the co-design and co-development of user-friendly, accessible, secure and efficient telemedicine/telehealth and other digital solutions

Amendment 183

Amendment 183

Proposal for a regulation

Proposal for a regulation

Annex I — point k — point iii

Annex I — point k — point iii

| Text proposed by the Commission | Amendment |
| --- | --- |
| (iii) | Communication to promote
  disease prevention and
  healthy lifestyles, in cooperation with all concerned actors at international, Union
  and
  national level. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii)

Communication to promote
  disease prevention and
  healthy lifestyles, in cooperation with all concerned actors at international, Union
  and
  national level.

disease prevention and

and

| (iii) | Communication to promote
  health,
  healthy lifestyles
  and disease prevention
  , in cooperation with all concerned actors at international, Union, national
  and regional
  level; |
| --- | --- |

(iii)

Communication to promote
  health,
  healthy lifestyles
  and disease prevention
  , in cooperation with all concerned actors at international, Union, national
  and regional
  level;

health,

and disease prevention

and regional

Amendment 184

Amendment 184

Proposal for a regulation

Proposal for a regulation

Annex I — point k — point iii a (new)

Annex I — point k — point iii a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (iii a) | Awareness-raising campaigns for the general population as well as for targeted groups and stakeholder-led projects, including prevention of and combating disinformation; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii a)

(iii a)

Awareness-raising campaigns for the general population as well as for targeted groups and stakeholder-led projects, including prevention of and combating disinformation;

Awareness-raising campaigns for the general population as well as for targeted groups and stakeholder-led projects, including prevention of and combating disinformation;

Amendment 185

Amendment 185

Proposal for a regulation

Proposal for a regulation

Annex I — point k — point iii b (new)

Annex I — point k — point iii b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (iii b) | Communication activities aimed at fighting against misinformation and disinformation, such as fake news, regarding medicines, vaccines, health products, causes and treatment of diseases; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii b)

(iii b)

Communication activities aimed at fighting against misinformation and disinformation, such as fake news, regarding medicines, vaccines, health products, causes and treatment of diseases;

Communication activities aimed at fighting against misinformation and disinformation, such as fake news, regarding medicines, vaccines, health products, causes and treatment of diseases;

Amendment 186

Amendment 186

Proposal for a regulation

Proposal for a regulation

Annex I — point k — point iii c (new)

Annex I — point k — point iii c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (iii c) | Communication to citizens on health risks and health determinants; |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii c)

(iii c)

Communication to citizens on health risks and health determinants;

Communication to citizens on health risks and health determinants;

Amendment 187

Amendment 187

Proposal for a regulation

Proposal for a regulation

Annex I — point k — point iii d (new)

Annex I — point k — point iii d (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | (iii d) | Communication, information and awareness campaigns on blood components, organs, tissues and cells donation that alert the public to the importance of such donation, in terms of solidarity, health policy and therapeutical benefits. |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

(iii d)

(iii d)

Communication, information and awareness campaigns on blood components, organs, tissues and cells donation that alert the public to the importance of such donation, in terms of solidarity, health policy and therapeutical benefits.

Communication, information and awareness campaigns on blood components, 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 188

Amendment 188

Proposal for a regulation

Proposal for a regulation

Annex II — part A — point I

Annex II — part A — point I

| Text proposed by the Commission | Amendment |
| --- | --- |
| I. | Quality and completeness of EU and MS preparedness and response planning for serious cross border threats to health |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

I.

Quality and completeness of EU and MS preparedness and response planning for serious cross border threats to health

| I. | Quality and completeness of the preparedness and response planning of the Union and of Member States for serious cross border threats to health
  , including resilience assessment indicators across the Union |
| --- | --- |

I.

Quality and completeness of the preparedness and response planning of the Union and of Member States for serious cross border threats to health
  , including resilience assessment indicators across the Union

, including resilience assessment indicators across the Union

Amendment 189

Amendment 189

Proposal for a regulation

Proposal for a regulation

Annex II — part A — point II

Annex II — part A — point II

| Text proposed by the Commission | Amendment |
| --- | --- |
| II. | Access to centrally authorised medicines, e.g. number of orphan authorisations, Advanced Therapy Medicinal Products, Paediatric Use Medicinal Products or vaccines, for unmet needs |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

II.

Access to centrally authorised medicines, e.g. number of orphan authorisations, Advanced Therapy Medicinal Products, Paediatric Use Medicinal Products or vaccines, for unmet needs

| II. | Access to centrally authorised medicines
  and medical devices
  , e.g. number of
  existing and new
  orphan authorisations, Advanced Therapy Medicinal Products, Paediatric Use Medicinal Products or vaccines, for unmet needs |
| --- | --- |

II.

Access to centrally authorised medicines
  and medical devices
  , e.g. number of
  existing and new
  orphan authorisations, Advanced Therapy Medicinal Products, Paediatric Use Medicinal Products or vaccines, for unmet needs

and medical devices

existing and new

Amendment 190

Amendment 190

Proposal for a regulation

Proposal for a regulation

Annex II — part A — point III

Annex II — part A — point III

| Text proposed by the Commission | Amendment |
| --- | --- |
| III. | Number of actions and best practices directly contributing to
  the SDG 3.4/Member
  State |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

III.

Number of actions and best practices directly contributing to
  the SDG 3.4/Member
  State

the SDG 3.4/Member

| III. | Number of actions and best practices directly contributing to
  achieve Universal Health Coverage / Member
  State |
| --- | --- |

III.

Number of actions and best practices directly contributing to
  achieve Universal Health Coverage / Member
  State

achieve Universal Health Coverage / Member

Amendment 191

Amendment 191

Proposal for a regulation

Proposal for a regulation

Annex II — part A — point IV

Annex II — part A — point IV

| Text proposed by the Commission | Amendment |
| --- | --- |
| IV. | Implementation of
  best practices
  by EU Member States |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

IV.

Implementation of
  best practices
  by EU Member States

best practices

| IV. | Implementation of
  health programmes
  by EU Member States
  , that promote health, prevent diseases and address health inequalities |
| --- | --- |

IV.

Implementation of
  health programmes
  by EU Member States
  , that promote health, prevent diseases and address health inequalities

health programmes

, that promote health, prevent diseases and address health inequalities

Amendment 192

Amendment 192

Proposal for a regulation

Proposal for a regulation

Annex II — part A — point IV a (new)

Annex II — part A — point IV a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | IV a. | Implementation of the European Health Data Space (EHDS) |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

IV a.

IV a.

Implementation of the European Health Data Space (EHDS)

Amendment 193

Amendment 193

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 1 a (new)

Annex II — part B — point 1 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1a. | Number of new procedures for accelerated development and assessment of medicines for major public health needs, where relevant taking into account novel technologies |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1a.

1a.

Number of new procedures for accelerated development and assessment of medicines for major public health needs, where relevant taking into account novel technologies

Amendment 194

Amendment 194

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 1b (new)

Annex II — part B — point 1b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1b. | Number of Member States with adequate level of digital health infrastructure |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1b.

1b.

Number of Member States with adequate level of digital health infrastructure

Amendment 195

Amendment 195

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 1 c (new)

Annex II — part B — point 1 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1c. | Number of Member States that implemented the European Electronic Health Record |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1c.

1c.

Number of Member States that implemented the European Electronic Health Record

Amendment 196

Amendment 196

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 1d (new)

Annex II — part B — point 1d (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 1d. | Proportion of Member States’ population of citizens with access to their data on the EHDS, per Member State |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

1d.

1d.

Proportion of Member States’ population of citizens with access to their data on the EHDS, per Member State

Amendment 197

Amendment 197

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 3

Annex II — part B — point 3

| Text proposed by the Commission | Amendment |
| --- | --- |
| 3. | Number of vaccine doses
  distributed |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3.

Number of vaccine doses
  distributed

distributed

| 3. | Number of vaccine doses
  made available by type and by Member State |
| --- | --- |

3.

Number of vaccine doses
  made available by type and by Member State

made available by type and by Member State

Amendment 198

Amendment 198

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 3 a (new)

Annex II — part B — point 3 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 3a. | Vaccination coverage, by age, and by vaccine-preventable-disease |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

3a.

3a.

Vaccination coverage, by age, and by vaccine-preventable-disease

Amendment 199

Amendment 199

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 6

Annex II — part B — point 6

| Text proposed by the Commission | Amendment |
| --- | --- |
| 6. | Age-standardised five-year net survival of
  cervical, breast and colorectal
  cancer |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

6.

Age-standardised five-year net survival of
  cervical, breast and colorectal
  cancer

cervical, breast and colorectal

| 6. | Age-standardised five-year net survival of cancer
  by type, age, gender and Member State |
| --- | --- |

6.

Age-standardised five-year net survival of cancer
  by type, age, gender and Member State

by type, age, gender and Member State

Amendment 200

Amendment 200

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 6 a (new)

Annex II — part B — point 6 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 6a. | Age-standardised five-year net survival rate for paediatric cancer by type, age, gender and Member State |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

6a.

6a.

Age-standardised five-year net survival rate for paediatric cancer by type, age, gender and Member State

Amendment 201

Amendment 201

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 6 b (new)

Annex II — part B — point 6 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 6b. | Screening coverage for breast, cervical and colorectal cancer screening programmes, by type, age, gender and Member State |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

6b.

6b.

Screening coverage for breast, cervical and colorectal cancer screening programmes, by type, age, gender and Member State

Amendment 202

Amendment 202

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 7

Annex II — part B — point 7

| Text proposed by the Commission | Amendment |
| --- | --- |
| 7. | Ratio of Cancer Registries (CRs) and number of Member States (MSs) reporting information on
  cervical, breast, and colorectal
  cancer stage at diagnosis |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

7.

Ratio of Cancer Registries (CRs) and number of Member States (MSs) reporting information on
  cervical, breast, and colorectal
  cancer stage at diagnosis

cervical, breast, and colorectal

| 7. | Ratio of Cancer Registries (CRs) and number of Member States (MSs) reporting information on cancer stage at diagnosis |
| --- | --- |

7.

Ratio of Cancer Registries (CRs) and number of Member States (MSs) reporting information on cancer stage at diagnosis

Amendment 203

Amendment 203

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 7 a (new)

Annex II — part B — point 7 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 7a. | Ratio of palliative care admissions and outcome result for cancer and paediatric cancer, by type, age, gender and Member State |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

7a.

7a.

Ratio of palliative care admissions and outcome result for cancer and paediatric cancer, by type, age, gender and Member State

Amendment 204

Amendment 204

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 7 b (new)

Annex II — part B — point 7 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 7b. | Ratio of Paediatric Cancer Registries (CRs) /Member State and number of Member States (MSs) reporting information on paediatric cancer stage at diagnosis |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

7b.

7b.

Ratio of Paediatric Cancer Registries (CRs) /Member State and number of Member States (MSs) reporting information on paediatric cancer stage at diagnosis

Amendment 205

Amendment 205

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 7 c (new)

Annex II — part B — point 7 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 7c. | Prevalence of major chronic diseases per Member State, by disease, gender and age |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

7c.

7c.

Prevalence of major chronic diseases per Member State, by disease, gender and age

Amendment 206

Amendment 206

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 7 d (new)

Annex II — part B — point 7 d (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 7d. | Age-standardized NCD mortality rate (per 100 000 people), by disease |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

7d.

7d.

Age-standardized NCD mortality rate (per 100 000 people), by disease

Amendment 207

Amendment 207

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 7 e (new)

Annex II — part B — point 7 e (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 7e. | Percentage of HIV/AIDS patients with access to adequate treatment, by Member State, gender and age |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

7e.

7e.

Percentage of HIV/AIDS patients with access to adequate treatment, by Member State, gender and age

Amendment 208

Amendment 208

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 7 f (new)

Annex II — part B — point 7 f (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 7f. | Proportion of tuberculosis patients with access to adequate treatment, by Member State, gender and age |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

7f.

7f.

Proportion of tuberculosis patients with access to adequate treatment, by Member State, gender and age

Amendment 209

Amendment 209

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 8

Annex II — part B — point 8

| Text proposed by the Commission | Amendment |
| --- | --- |
| 8. | Smoking
  prevalence |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

8.

Smoking
  prevalence

Smoking

| 8. | Age standardized
  prevalence
  of tobacco use, by gender |
| --- | --- |

8.

Age standardized
  prevalence
  of tobacco use, by gender

Age standardized

of tobacco use, by gender

Amendment 228

Amendment 228

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 8 a (new)

Annex II — part B — point 8 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 8a. | Age-standardised prevalence of harmful use of alcohol, by gender and age |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

8a.

8a.

Age-standardised prevalence of harmful use of alcohol, by gender and age

Amendment 210

Amendment 210

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 9

Annex II — part B — point 9

| Text proposed by the Commission | Amendment |
| --- | --- |
| 9. | Number of shortages of medicines in the
  single point of contact network |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

9.

Number of shortages of medicines in the
  single point of contact network

single point of contact network

| 9. | Number of shortages of medicines in the
  Member States |
| --- | --- |

9.

Number of shortages of medicines in the
  Member States

Member States

Amendment 211

Amendment 211

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 9 a (new)

Annex II — part B — point 9 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 9a. | Actions aimed at stimulating the production of essential APIs and medicinal products in the EU |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

9a.

9a.

Actions aimed at stimulating the production of essential APIs and medicinal products in the EU

Amendment 212

Amendment 212

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 12 a (new)

Annex II — part B — point 12 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 12a. | Antimicrobial use by ATC type and per Member States |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

12a.

12a.

Antimicrobial use by ATC type and per Member States

Amendment 213

Amendment 213

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 12 b (new)

Annex II — part B — point 12 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 12b. | Attributable mortality to Healthcare Associated Infections, by age, gender and Member State |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

12b.

12b.

Attributable mortality to Healthcare Associated Infections, by age, gender and Member State

Amendment 214

Amendment 214

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 12 c (new)

Annex II — part B — point 12 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 12c. | Avoidable deaths attributed to cardiovascular disease, cancer, diabetes, DALYs attributable to the NCDs and QALYs, chronic respiratory disease, for persons aged less than 75 years, by gender and Member State |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

12c.

12c.

Avoidable deaths attributed to cardiovascular disease, cancer, diabetes, DALYs attributable to the NCDs and QALYs, chronic respiratory disease, for persons aged less than 75 years, by gender and Member State

Amendment 215

Amendment 215

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 13

Annex II — part B — point 13

| Text proposed by the Commission | Amendment |
| --- | --- |
| 13. | Number of
  hospital
  units involved in ERN and of patients diagnosed and treated by the members of ERN networks |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

13.

Number of
  hospital
  units involved in ERN and of patients diagnosed and treated by the members of ERN networks

hospital

| 13. | Number of
  health
  units involved in ERN and of patients diagnosed and treated by the members of ERN networks |
| --- | --- |

13.

Number of
  health
  units involved in ERN and of patients diagnosed and treated by the members of ERN networks

health

Amendment 216

Amendment 216

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 14 a (new)

Annex II — part B — point 14 a (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 14a. | Number of health impact assessments of Union policies |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

14a.

14a.

Number of health impact assessments of Union policies

Amendment 217

Amendment 217

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 14 b (new)

Annex II — part B — point 14 b (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 14b. | Age-standardised obesity prevalence, by gender, age and Member State |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

14b.

14b.

Age-standardised obesity prevalence, by gender, age and Member State

Amendment 218

Amendment 218

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 14 c (new)

Annex II — part B — point 14 c (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 14c. | Maternal mortality ratio, by age and by Member State |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

14c.

14c.

Maternal mortality ratio, by age and by Member State

Amendment 219

Amendment 219

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 14 d (new)

Annex II — part B — point 14 d (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 14d. | Infant mortality rate by Member State |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

14d.

14d.

Infant mortality rate by Member State

Amendment 229

Amendment 229

Proposal for a regulation

Proposal for a regulation

Annex II — part B — point 14 e (new)

Annex II — part B — point 14 e (new)

| Text proposed by the Commission | Amendment |
| --- | --- |
| | 14e. | Age-standardized deaths attributable to environmental pollution (per 100 000 people), by gender and age |

Text proposed by the Commission

Text proposed by the Commission

Amendment

Amendment

14e.

14e.

Age-standardized deaths attributable to environmental pollution (per 100 000 people), by gender and age

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(1)  The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A9-0196/2020).

1

(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)0112 of 13.03.2020.

8

(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)0112 of 13.03.2020.

8

(10)  Decision 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).

10

(10)  Decision 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).

10

(11)  Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU, COM(2018)0051 of 31.01.2018.

11

(11)  Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU, COM(2018)0051 of 31.01.2018.

11

(12)  Council Conclusions on Common values and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1).

12

(11a)  
  Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22).

11a

Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255, 30.9.2005, p. 22).

(12)  Council Conclusions on Common values and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1).

12

(12a)  
  Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).

12a

Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).

(13)  Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Next steps for a sustainable European future. European action for sustainability COM(2016)0739 of 22.11.2016.

13

(13)  Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Next steps for a sustainable European future. European action for sustainability COM(2016)0739 of 22.11.2016.

13

(14)  Communication from the Commission to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, COM(2017)0339 of 29.6.2017.

14

(14)  Communication from the Commission to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, COM(2017)0339 of 29.6.2017.

14

(15)  Communication of the Commission to the European Parliament, the Council and the European economic and Social Committee ‘European Union Strategic Approach to Pharmaceuticals in the Environment’, COM(2019)0128 of 11.03.2019.

15

(15)  Communication of the Commission to the European Parliament, the Council and the European economic and Social Committee ‘European Union Strategic Approach to Pharmaceuticals in the Environment’, COM(2019)0128 of 11.03.2019.

15

(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).

16

(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).

16

(16a)  

  OJ C 192, 7.6.2019, p. 5.

16a

OJ C 192, 7.6.2019, p. 5.

(19)  Council conclusions on the EU role in Global Health, 3011th Foreign Affairs Council meeting, Brussels, 10 May 2010.

19

(19)  Council conclusions on the EU role in Global Health, 3011th Foreign Affairs Council meeting, Brussels, 10 May 2010.

19

(20)  Council 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).

20

(20)  Council 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).

20

(1a)  
  Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directive 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, p. 87)

1a

Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts, amending Council Directive 78/660/EEC and 83/349/EEC and repealing Council Directive 84/253/EEC (OJ L 157, 9.6.2006, p. 87)

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