European Parliament 2019-2024

Committee on the Environment, Public Health and Food Safety

2020/0102(COD)

16.7.2020

AMENDMENTS 115 - 519

Draft report Cristian-Silviu Buşoi (PE653.803v01-00)

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”)

Proposal for a regulation (COM(2020)0405 – C9-0152/2020 – 2020/0102(COD))

AM\1207705EN.docx PE653.822v01-00

EN United in diversityEN AM_Com_LegReport

PE653.822v01-00 2/276 AM\1207705EN.docx EN Amendment 115Sara Cerdas, Tudor Ciuhodaru, Rovana Plumb, Milan Brglez, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 2

Text proposed by the Commission Amendment

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

Or. en

Amendment 116 Pascal Arimont, Cindy Franssen, Esther de Lange

Proposal for a regulation Recital 3

Text proposed by the Commission Amendment

(3) Article 168 TFEU provides that the (3) Article 168 TFEU provides that the Union is to complement and support Union is to complement and support national health policies, encourage national health policies, encourage cooperation between Member States and cooperation between Member States, promote the coordination between their particularly in border regions, and programmes, in full respect of the promote the coordination between their responsibilities of the Member States for programmes, in full respect of the the definition of their health policies and responsibilities of the Member States for the organisation and delivery of health the definition of their health policies and services and medical care. the organisation and delivery of health services and medical care.

Or. en

Amendment 117 Joanna Kopcińska

AM\1207705EN.docx 3/276 PE653.822v01-00 EN Proposal for a regulation Recital 3

Text proposed by the Commission Amendment

(3) Article 168 TFEU provides that the (3) Article 168 TFEU provides that the Union is to complement and support Union is to complement and support national health policies, encourage national health policies, encourage cooperation between Member States and cooperation between Member States and promote the coordination between their promote the coordination between their programmes, in full respect of the programmes, in full respect of the responsibilities of the Member States for responsibilities of each Member State to the definition of their health policies and define their own health policy and to the organisation and delivery of health organise, deliver and manage health services and medical care. services and medical care.

Or. en

Amendment 118 Sirpa Pietikäinen

Proposal for a regulation Recital 3 a (new)

Text proposed by the Commission Amendment

(3a) While the treaties oblige the EU to improve public health, preventing physical, and mental illness and diseases and obviating sources of danger to physical and mental health, the new and upcoming challenges, like COVID-19, have clearly shown that EU needs to take a stronger role ensuring the needed health policies are in place and health and wellbeing for its citizens because the Member States alone don´t have the adequate skills, capacities and resources to face the increasing and more complex health challenges.

Or. en

Amendment 119 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie

PE653.822v01-00 4/276 AM\1207705EN.docx EN Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 3 a (new)

Text proposed by the Commission Amendment

(3a) In its communication of 20 October 2010 entitled ‘Solidarity in Health: Reducing Health Inequalities in the EU’, the Commission considered that there is a social gradient in health status in all the EU Member States. The World Health Organisation defines this social gradient as being the link between socioeconomic inequalities and inequalities in the areas of health and access to healthcare.

Or. en

Amendment 120 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 3 b (new)

Text proposed by the Commission Amendment

(3b) Health inequalities are rooted in social inequalities in terms of living conditions and models of social behaviour linked to gender, race, educational standards, employment, income and the unequal distribution of access to medical assistance, sickness prevention and health promotion services. The programme should facilitate the establishment of a common set of health determinants to monitor health inequalities by age, sex, socio-economic status and geographic location and introduce a methodology for auditing the health situation in Member States with the aim of identifying and

AM\1207705EN.docx 5/276 PE653.822v01-00 EN prioritising areas in need of improvement and increased fundings. In its annual implementation assessment report, the Commission should evaluate the effectiveness of measures to reduce health inequalities resulting from policies relating to the social, economic and environmental risk factors. Through the allocation of fundings to the relevant regional and local stakeholders, the Programme should support a ‘local care approach’ to provide integrated healthcare, accessible at local or regional level, enabling patients to be better supported in their own local and social environment. The programme could also facilitate partnerships between border regions in order to share the cost of infrastructure and personnel and reduce inequalities with regard to health, particularly in respect of access to state- of-the-art equipment. The programme should therefore be implemented in close links with EU cohesion policy and structural funds.

Or. en

Amendment 121 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 4 a (new)

Text proposed by the Commission Amendment

(4a) Article 191 TFEU provides that the Union should contribute to protecting human health through a Union policy on the environment.

Or. en

PE653.822v01-00 6/276 AM\1207705EN.docx EN Amendment 122 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Recital 5

Text proposed by the Commission Amendment

(5) On 11 March 2020 the World (5) On 11 March 2020 the World Health Organization (WHO) declared the Health Organization (WHO), due to an novel coronavirus (COVID-19) outbreak a exponential increase of cases, declared global pandemic. That pandemic has COVID-19 (the disease resulting from the caused an unprecedented worldwide health novel coronavirus SARS-CoV-2) outbreak crisis with severe socio-economic a global pandemic. The COVID-19 consequences and human suffering. 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 Union, caused an unprecedented worldwide health crisis with severe socio- economic consequences and human suffering, particularly affecting people with chronic conditions and hitting the most vulnerable, patients, women, carers and the elderly the hardest. The world continues the fight against this unprecedented health crisis, which has led to lock downs and restrictions on the circulation of people, animals, food, medicines and others.

Or. en

Amendment 123 Dolors Montserrat

Proposal for a regulation Recital 5

Text proposed by the Commission Amendment

(5) On 11 March 2020 the World (5) On 11 March 2020 the World Health Organization (WHO) declared the Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a novel SARS-CoV-2 coronavirus and

AM\1207705EN.docx 7/276 PE653.822v01-00 EN global pandemic. That pandemic has associated respiratory disease (COVID19) caused an unprecedented worldwide health outbreak a global pandemic. That crisis with severe socio-economic pandemic, and more specifically the consequences and human suffering. severe acute respiratory disease causing both premature death and chronic lung conditions that it involves, has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering, particularly affecting people with chronic conditions and hitting the most vulnerable, patients, carers and the elderly the hardest.

Or. en

Justification

Specifying the respiratory aspects of SARS-CoV2 in the draft report is helpful. However, another helpful addition would be necessary as almost all COVID-19 fatalities had an underlying, other chronic health conditions, and older people were particularly affected.

Amendment 124 Sirpa Pietikäinen

Proposal for a regulation Recital 5

Text proposed by the Commission Amendment

(5) On 11 March 2020 the World (5) On 11 March 2020 the World Health Organization (WHO) declared the Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a novel SARS-CoV-2 coronavirus and global pandemic. That pandemic has associated respiratory disease (COVID19) caused an unprecedented worldwide health outbreak a global pandemic. That crisis with severe socio-economic pandemic, and more specifically the consequences and human suffering. severe acute respiratory disease causing both premature death and chronic lung conditions that it involves, has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering, particularly affecting the most vulnerable, patients, people suffering from chronic diseases, women and carers.

Or. en

PE653.822v01-00 8/276 AM\1207705EN.docx EN Justification

Sex and gender—which includes both biological and social influences—are critical to health. Many diseases affect men and women differently, including diabetes, depression and cardiovascular disease. In addition, women do not present with the same symptoms and respond differently to treatments than do men. Women also have higher rates of disease such as breast cancer, osteoporosis and auto-immune diseases (EIWH 2018a; Eurostat 2017b; ENGENDER 2011; EIWH 2017ab).

Amendment 125 Joanna Kopcińska

Proposal for a regulation Recital 5

Text proposed by the Commission Amendment

(5) On 11 March 2020 the World (5) On 11 March 2020 the World Health Organization (WHO) declared the Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a novel coronavirus (COVID-19) outbreak a global pandemic. That pandemic has global pandemic. This pandemic has since caused an unprecedented worldwide become the defining global health crisis of health crisis with severe socio-economic our time, causing severe socio-economic consequences and human suffering. consequences and human suffering. The extent, depth and breadth of this crisis has demonstrated the added value of the EU's actions, which serve to complement national policies in the field of public health.

Or. en

Amendment 126 Mairead McGuinness

Proposal for a regulation Recital 5

Text proposed by the Commission Amendment

(5) On 11 March 2020 the World (5) On 11 March 2020 the World Health Organization (WHO) declared the Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a novel coronavirus (COVID-19) outbreak a global pandemic. That pandemic has global pandemic. That pandemic has caused an unprecedented worldwide health caused an unprecedented worldwide health

AM\1207705EN.docx 9/276 PE653.822v01-00 EN crisis with severe socio-economic crisis with severe socio-economic consequences and human suffering. consequences and human suffering. Its impact has not been evenly felt: people more vulnerable in society, such as those with pre-existing chronic conditions or living in institutionalised care, have been at particular risk from the disease.

Or. en

Amendment 127 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 5

Text proposed by the Commission Amendment

(5) On 11 March 2020 the World (5) On 11 March 2020 the World Health Organization (WHO) declared the Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a novel coronavirus (COVID-19) outbreak a global pandemic. That pandemic has global pandemic. That pandemic has caused an unprecedented worldwide health caused an unprecedented worldwide health crisis with severe socio-economic crisis with severe socio-economic consequences and human suffering. consequences and human suffering, particularly affecting people with chronic conditions and hitting the most vulnerable, patients, women, carers and the elderly the hardest.

Or. en

Amendment 128 Sirpa Pietikäinen

Proposal for a regulation Recital 5 a (new)

Text proposed by the Commission Amendment

(5a) Women have been impacted disproportionately by the pandemic response measures and their long-term effects, must not compound existing inequities. Women across the lifespan

PE653.822v01-00 10/276 AM\1207705EN.docx EN remain under-represented in biomedical and health research and data. Consequently, the evidence base is weaker for women as well as for older people, many conditions are underdiagnosed in women, such as cardiovascular disease. Medicinal products are safer and more effective for everyone when clinical research studies include diverse population groups. To reduce inequalities and health disparities, sex and gender should be incorporated throughout the health process from design of clinical trial protocols, data analysis, health technology assessment and access to care.

Or. en

Justification

Diseases and their treatments affect men and women differently; therefore, sex, and gender factors must be integrated in biomedical and health research to provide effective, equitable and efficient healthcare.

Amendment 129 Michèle Rivasi

Proposal for a regulation Recital 5 a (new)

Text proposed by the Commission Amendment

(5a) On 11 March 2020 the World Health Organization (WHO) declared the novel SARS-CoV-2coronavirus and associated respiratory disease (COVID- 19) outbreak a global pandemic. That pandemic, and more specifically the severe acute respiratory disease causing both premature death and chronic lung conditions that it involves, has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering. The severity of the crisis demonstrates also the importance of Union action on the prevention and management of respiratory diseases.

AM\1207705EN.docx 11/276 PE653.822v01-00 EN Or. en

Justification

Like AM 1 of the rapporteur, with the addition of a reference to "prevention" of respiratory diseases.

Amendment 130 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 5 a (new)

Text proposed by the Commission Amendment

(5a) According to the definition of the World Health Organisation (WHO), "Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." At this stage, the Union has not yet adopted a common definition of health. Following the COVID-19crisis. The Commission should propose a broader definition of the “public health” at European level.

Or. en

Amendment 131 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Andreas Glück, Linea Søgaard-Lidell, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 5 b (new)

Text proposed by the Commission Amendment

(5b) The Programme should strongly advocate for the promotion of effective prevention and hygiene measures to

PE653.822v01-00 12/276 AM\1207705EN.docx EN prevent and control infections, reduce the burden of resistant infections and healthcare-associated infections and secure the availability of effective antimicrobials. Important habits, including hygiene practices, should be developed from an early age when children are best able to integrate them. The Programme should also support educational prevention programmes on health for youth (harmless behaviours, healthy nutrition, sport, etc.)

Or. en

Amendment 132 Rob Rooken

Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) Member States are responsible for responsible for their health policies, they their health policies. However, the are expected to protect public health in a COVID-19 crisis has demonstrated that spirit of European solidarity8. Experience cooperation among the Member States is from the ongoing COVID-19 crisis has welcome in order to prevent and control demonstrated that there is a need for a the spread of severe human diseases across further firm action at Union level to borders. 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. ______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,

AM\1207705EN.docx 13/276 PE653.822v01-00 EN COM(2020)112 final of 13.03.2020.

Or. nl

Amendment 133 Joanna Kopcińska

Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is scope for the further firm action at Union level to Union to better deliver on public health support cooperation and coordination policy within the existing parameters of among the Member States in order to the Treaties to support cooperation and improve the prevention and control of the coordination among the Member States in spread of severe human diseases across order to improve the prevention and borders, to combat other serious cross- control of the spread of severe human border threats to health and to safeguard diseases across borders, to develop, test the health and well-being of people in the and make available products for the Union. prevention and treatment of diseases, to combat other serious cross-border threats to health and to safeguard the health and well-being of people in the Union. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

Amendment 134 Pascal Arimont, Cindy Franssen, Esther de Lange

PE653.822v01-00 14/276 AM\1207705EN.docx EN Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity8 . Despite the from the ongoing COVID-19 crisis has reintroduction of internal borders at a demonstrated that there is a need for a time where solidarity between Member further firm action at Union level to States was the most needed, several support cooperation and coordination healthcare projects between cross-border among the Member States in order to regions, funded by Interreg programmes, improve the prevention and control of the have contributed to the fight against the spread of severe human diseases across COVID-19 crisis. Experience from the borders, to combat other serious cross- ongoing crisis has demonstrated that there border threats to health and to safeguard is a need for a further firm action at Union the health and well-being of people in the level to support cooperation and Union. coordination among the Member States as well as between neighbouring border regions 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. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

Amendment 135 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Recital 6

AM\1207705EN.docx 15/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity. Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States to support improve the prevention and control of the rights- and evidence-based approaches spread of severe human diseases across that have a high impact in order to borders, to combat other serious cross- improve preparedness for, prevention and border threats to health and to safeguard a timely and effective control of the spread the health and well-being of people in the of severe human infections and diseases Union. across borders, to develop and guarantee the availability and accessibility of 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 people in the Union. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

Amendment 136 Christian Ehler on behalf of the EPP Group Dan Nica on behalf of the S&D Group Ville Niinistö on behalf of the Greens/EFA Group Marisa Matias on behalf of the GUE/NGL Group Cristian-Silviu Buşoi

PE653.822v01-00 16/276 AM\1207705EN.docx EN Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity8. Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States in order to improve the prevention and control of the improve the prevention and control of the spread of severe human diseases across spread of severe human diseases across borders, to combat other serious cross- borders, to develop and guarantee the border threats to health and to safeguard availability and accessibility of products the health and well-being of people in the for the prevention and treatment of Union. diseases, to ensure that all Member States have fair access to medical products, to combat other serious cross-border threats to health and to prevent and respond to medicines shortages in a timely manner that takes fairly and comprehensively into account the individual needs of each Member State, and to safeguard the health and well-being of all people in the Union, including by combating vaccine hesitancy that may decrease immunisation coverage among certain population groups. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

Amendment 137 Nathalie Colin-Oesterlé

AM\1207705EN.docx 17/276 PE653.822v01-00 EN Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8. Experience spirit of European solidarity8. Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States, as well as a improve the prevention and control of the permanent structured and coordinated spread of severe human diseases across dialogue between the authorities and the borders, to combat other serious cross- parties concerned, in order to improve the border threats to health and to safeguard prevention and control of the spread of the health and well-being of people in the severe human diseases across borders, to Union. combat other serious cross-border threats to health, to safeguard the health and well- being of people in the Union, and to take all necessary measures to combat shortages by increasing the resilience of health systems in order to ensure that European citizens have access to medicines and medical equipment. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.2020. COM(2020)112 final of 13.03.2020.

Or. fr

Amendment 138 Michèle Rivasi

Proposal for a regulation Recital 6

PE653.822v01-00 18/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States to support improve the prevention and control of the rights- and evidence-based approaches spread of severe human diseases across with significant impact in order to improve borders, to combat other serious cross- the prevention and control of the spread of border threats to health and to safeguard severe human diseases across borders, to the health and well-being of people in the develop and make available products for Union. the prevention and treatment of diseases without discrimination, to combat other serious cross-border threats to health, to prevent and respond to medicines shortages, and to safeguard the health and well-being of all people in the Union. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

Amendment 139 Margarita de la Pisa Carrión

Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8. Experience spirit of European solidarity8. Experience

AM\1207705EN.docx 19/276 PE653.822v01-00 EN from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States in order to improve the prevention and control of the improve the prevention and control of the spread of severe human diseases across spread of severe human diseases across borders, to combat other serious cross- borders, as well as to ensure crisis- border threats to health and to safeguard relevant products for the most affected the health and well-being of people in the areas, to develop and make available Union. products for the prevention and treatment of diseases, to combat other serious cross- border threats to health and to safeguard the health and well-being of people in the Union, avoiding any kind of discrimination in terms of hospitalisation and treatment. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. es

Amendment 140 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity8. Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States in order to improve the prevention and control of the improve the prevention and control of the

PE653.822v01-00 20/276 AM\1207705EN.docx EN spread of severe human diseases across spread of severe human diseases across borders, to combat other serious cross- borders, to develop and guarantee the border threats to health and to safeguard availability and accessibility of products the health and well-being of people in the for the prevention and treatment of Union. diseases, to combat other serious cross- border threats to health and to safeguard the health and well-being of people in the Union. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

Amendment 141 Danilo Oscar Lancini

Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States, as well as a improve the prevention and control of the permanent structured and coordinated spread of severe human diseases across dialogue between authorities and relevant borders, to combat other serious cross- stakeholders, in order to improve the border threats to health and to safeguard prevention and control of the spread of the health and well-being of people in the severe human diseases across borders, to Union. combat other serious cross-border threats to health and to safeguard the health and well-being of people in the Union. ______

AM\1207705EN.docx 21/276 PE653.822v01-00 EN 8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

Amendment 142 Cristian-Silviu Buşoi

Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States, as well as a improve the prevention and control of the permanent structured and coordinated spread of severe human diseases across dialogue between authorities and relevant borders, to combat other serious cross- stakeholders, in order to improve the border threats to health and to safeguard prevention and control of the spread of the health and well-being of people in the severe human diseases across borders, to Union. combat other serious cross-border threats to health and to safeguard the health and well-being of people in the Union. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

PE653.822v01-00 22/276 AM\1207705EN.docx EN Amendment 143 Frédérique Ries

Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States, as well as a improve the prevention and control of the permanent structured and coordinated spread of severe human diseases across dialogue between authorities and relevant borders, to combat other serious cross- stakeholders, in order to improve the border threats to health and to safeguard prevention and control of the spread of the health and well-being of people in the severe human diseases across borders, to Union. combat other serious cross-border threats to health and to safeguard the health and well-being of people in the Union. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

Amendment 144 Adam Jarubas

Proposal for a regulation Recital 6

AM\1207705EN.docx 23/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States and all relevant improve the prevention and control of the stakeholders, public, private and civil spread of severe human diseases across society, in a structured, regular, manner borders, to combat other serious cross- in order to improve the prevention and border threats to health and to safeguard control of the spread of severe human the health and well-being of people in the diseases across borders, to combat other Union. serious cross-border threats to health and to safeguard the health and well-being of people in the Union. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

Amendment 145 César Luena

Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to

PE653.822v01-00 24/276 AM\1207705EN.docx EN support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States as well as improve the prevention and control of the coordinated dialogue between authorities spread of severe human diseases across and relevant stakeholders, in order to borders, to combat other serious cross- improve the prevention and control of the border threats to health and to safeguard spread of severe human diseases across the health and well-being of people in the borders, to combat other serious cross- Union. border threats to health and to safeguard the health and well-being of people in the Union. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

Amendment 146 Mairead McGuinness

Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8 . Experience spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States, not only in improve the prevention and control of the response to the current crisis, but in spread of severe human diseases across general. This cooperation should improve borders, to combat other serious cross- the prevention and control of the spread of border threats to health and to safeguard severe human diseases across borders, the health and well-being of people in the combat other serious cross-border threats Union. to health and safeguard the health and well- being of people in the Union.

AM\1207705EN.docx 25/276 PE653.822v01-00 EN ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.220. COM(2020)112 final of 13.03.220.

Or. en

Amendment 147 Véronique Trillet-Lenoir, Stéphane Bijoux

Proposal for a regulation Recital 6

Text proposed by the Commission Amendment

(6) While Member States are (6) While Member States are responsible for their health policies, they responsible for their health policies, they are expected to protect public health in a are expected to protect public health in a spirit of European solidarity8. Experience spirit of European solidarity8. Experience from the ongoing COVID-19 crisis has from the ongoing COVID-19 crisis has demonstrated that there is a need for a demonstrated that there is a need for a further firm action at Union level to further firm action at Union level to support cooperation and coordination support cooperation and coordination among the Member States in order to among the Member States in order to improve the prevention and control of the improve the prevention and control of the spread of severe human diseases across spread of severe human diseases across borders, to combat other serious cross- borders, to combat other serious cross- border threats to health and to safeguard border threats to health and to safeguard the health and well-being of people in the the health and well-being of people in the Union. Union, regardless of where they are located, so that no one is overlooked. ______8 Communication to the European 8 Communication to the European Parliament, the European Council, the Parliament, the European Council, the Council, the European Central Bank, the Council, the European Central Bank, the European Investment Bank and the European Investment Bank and the Eurogroup on coordinated economic Eurogroup on coordinated economic response to the COVID-19 outbreak, response to the COVID-19 outbreak, COM(2020)112 final of 13.03.2020. COM(2020)112 final of 13.03.2020.

Or. fr

PE653.822v01-00 26/276 AM\1207705EN.docx EN Amendment 148 Cristian-Silviu Buşoi

Proposal for a regulation Recital 6 a (new)

Text proposed by the Commission Amendment

(6a) While the Union´s action in the field of health is limited, the Union shall follow a coherent public health strategy in order to respond to existing epidemics taking into consideration regional and national specificities and have the capacity to face future worrying realities and health threats, such as pandemics and cross-border threats, including antimicrobial resistance and the health impacts of the climate crisis. The Union shall support Member States in reducing health inequalities and in achieving universal health coverage, addressing the challenges of an ageing population, of chronic diseases, or disease prevention, in promoting a healthy lifestyle, prevention services and preparing their health systems for emerging technologies.

Or. en

Amendment 149 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 6 a (new)

Text proposed by the Commission Amendment

(6a) While the Union´s action in the field of health is limited, the Union shall follow a coherent public health strategy in order face future worrying realities and health threats, such as pandemics and cross-border threats, including antimicrobial resistance and the health

AM\1207705EN.docx 27/276 PE653.822v01-00 EN impacts of the climate crisis. The Union shall support Member States in reducing health inequalities and in achieving universal health coverage, addressing the challenges of an ageing population, of chronic diseases, or disease prevention, in promoting a healthy lifestyle, equal from a sex, gender and perspective to health and prevention services and preparing their health systems for emerging technologies.

Or. en

Amendment 150 Margarita de la Pisa Carrión

Proposal for a regulation Recital 6 a (new)

Text proposed by the Commission Amendment

(6a.) Although the Union’s action in the field of health is limited, it should have the ability to respond to future realities that may pose a threat to health, such as pandemics or antimicrobial resistance. It should also support the Member States in tackling the challenges of an ageing population, chronic diseases and the prevention of various age-related illnesses. Overall, priority should be given to promoting a healthy lifestyle. New technologies should also be introduced into the health systems.

Or. es

Amendment 151 Sirpa Pietikäinen

Proposal for a regulation Recital 6 a (new)

PE653.822v01-00 28/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(6a) While the Union´s action in the field of health is limited, the Union should have the capacity to face future worrying realities and health threats, such as pandemics and cross-border threats, antimicrobial resistance, and also to support Member States in addressing the challenges of an ageing population, of chronic diseases, or disease prevention, in promoting a healthy lifestyle, including a sex, gender and age perspective and preparing their health systems for emerging technologies.

Or. en

Amendment 152 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Recital 6 a (new)

Text proposed by the Commission Amendment

(6a) The pandemic has revealed the importance of public health policies, and their benefits for citizens, communities and the economy. Such policies are cost- saving and offer returns in the long term of 14:1, meaning that for each euro invested in public health policies, we have economic return of 14 euros.

Or. en

Amendment 153 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Christel Schaldemose, Mohammed Chahim

AM\1207705EN.docx 29/276 PE653.822v01-00 EN Proposal for a regulation Recital 6 b (new)

Text proposed by the Commission Amendment

(6b) While the Union´s action in the field of health is limited, the Union should follow a coherent public health strategy in order to flexibly respond to existing epidemics taking into consideration local specificities and having the capacity to face future worrying realities and health threats, such as pandemics and cross- border threats, including antimicrobial resistance and the health impacts of the climate crisis. The Union should support Member States in reducing health inequalities and in achieving universal health coverage, addressing the challenges of an ageing population, of chronic diseases, of disease prevention, in promoting a healthy lifestyle and preparing their health systems for emerging technologies.

Or. en

Amendment 154 Christian Ehler on behalf of the EPP Group Dan Nica on behalf of the S&D Group Martina Dlabajová on behalf of the Renew Group Ville Niinistö on behalf of the Greens/EFA Group Marisa Matias on behalf of the GUE/NGL Group Cristian-Silviu Buşoi

Proposal for a regulation Recital 6 b (new)

Text proposed by the Commission Amendment

(6b) While the Union´s action in the field of health is limited, the Union should

PE653.822v01-00 30/276 AM\1207705EN.docx EN have the capacity to face future risks, realities and health threats, such as pandemics and cross-border threats, including antimicrobial resistance and environmental health threats, and also to support Member States in addressing the challenges of an ageing population, of chronic and rare diseases, or disease prevention, and preparing their health systems for emerging technologies in order to fully benefit from the digital revolution while seeking synergies with other relevant EU programmes such as Horizon Europe, Digital Europe, Connecting Europe Facility programme or Space Programme.

Or. en

Amendment 155 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 6 c (new)

Text proposed by the Commission Amendment

(6c) The Commission’s communication of 20 October 2010 entitled ‘Solidarity in Health: Reducing Health Inequalities in the EU’ underlines that there is a social gradient in health status in the Member States and that the World Health Organisation defines this social gradient as being the link between socioeconomic inequalities and inequalities in the areas of health and access to healthcare. Health inequalities are rooted in social inequalities in terms of living conditions and models of social behaviour linked to gender, race, educational standards, employment, income and the unequal distribution of access to medical assistance, sickness prevention and health

AM\1207705EN.docx 31/276 PE653.822v01-00 EN promotion services.

Or. en

Amendment 156 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 7

Text proposed by the Commission Amendment

(7) It is therefore appropriate to (7) It is therefore appropriate to establish a new Programme for the Union's establish a new Programme for the Union's action in the field of health, called action in the field of health, called EU4Health Programme ('the Programme') EU4Health Programme ('the Programme') for the period 2021 -2027. In line with the for the period 2021 -2027. In line with the goals of the Union action and its goals of the Union action and its competences in the area of public health competences in the area of public health the Programme should place emphasis on the Programme should place emphasis on actions in relation to which there are actions in relation to which there are advantages and efficiency gains from advantages and efficiency gains from collaboration and cooperation at Union collaboration and cooperation at Union level and actions with an impact on the level and actions with an impact on the internal market. internal market. The EU regulates products relevant to health and health outcomes including, amongst others, pharmaceuticals, medical devices, tobacco, alcohol, food and chemicals, therefore the Programme should take into consideration regulation in such areas to improve the health outcomes in the EU. A holistic approach is needed to improve health outcomes, and EU policy-makers should ensure that the principle of 'health in all policies' is applied in all policy- making.

Or. en

Amendment 157 Pascal Arimont, Cindy Franssen, Esther de Lange

PE653.822v01-00 32/276 AM\1207705EN.docx EN Proposal for a regulation Recital 7

Text proposed by the Commission Amendment

(7) It is therefore appropriate to (7) It is therefore appropriate to establish a new Programme for the Union's establish a new Programme for the Union's action in the field of health, called action in the field of health, called EU4Health Programme ('the Programme') EU4Health Programme ('the Programme') for the period 2021 -2027. In line with the for the period 2021 -2027. In line with the goals of the Union action and its goals of the Union action and its competences in the area of public health competences in the area of public health the Programme should place emphasis on the Programme should place emphasis on actions in relation to which there are actions in relation to which there are advantages and efficiency gains from advantages and efficiency gains from collaboration and cooperation at Union collaboration at Union level as well as level and actions with an impact on the from cross-border cooperation at regional internal market. level and actions with an impact on the internal market.

Or. en

Amendment 158 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 7

Text proposed by the Commission Amendment

(7) It is therefore appropriate to (7) It is therefore appropriate to establish a new Programme for the Union's establish a new Programme for the Union's action in the field of health, called action in the field of public health, called EU4Health Programme ('the Programme') EU4Health Programme ('the Programme') for the period 2021 -2027. In line with the for the period 2021 -2027. In line with the goals of the Union action and its goals of the Union action and its competences in the area of public health competences in the area of public health the Programme should place emphasis on the Programme should place emphasis on actions in relation to which there are actions in relation to which there are advantages and efficiency gains from advantages and efficiency gains from collaboration and cooperation at Union collaboration and cooperation at Union level and actions with an impact on the level and actions with an impact on the internal market. internal market.

Or. en

AM\1207705EN.docx 33/276 PE653.822v01-00 EN Amendment 159 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Recital 9

Text proposed by the Commission Amendment

(9) In accordance with Regulation (9) In accordance with Regulation [European Union Recovery Instrument] [European Union Recovery Instrument] and within the limits of resources allocated and within the limits of resources allocated therein, recovery and resilience measures therein, recovery and resilience measures under the Programme should be carried out under the Programme should be carried out to address the unprecedented impact of the to address the unprecedented impact of the COVID-19 crisis. Such additional COVID-19 crisis and ensure that resilient resources should be used in such a way as healthcare and health systems are in to ensure compliance with the time limits place in preparation for future provided for in Regulation [European pandemics, improve the health status in Union Recovery Instrument]. societies and to ensure that people are healthier and therefore less susceptible to health threats. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument]. 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, through the support of the Commission and its coordination action to establish common acceptable parameters.

Or. en

Amendment 160 Christian Ehler on behalf of the EPP Group Dan Nica on behalf of the S&D Group Martina Dlabajová on behalf of the Renew Group

PE653.822v01-00 34/276 AM\1207705EN.docx EN Ville Niinistö on behalf of the Greens/EFA Group Cristian-Silviu Buşoi

Proposal for a regulation Recital 9

Text proposed by the Commission Amendment

(9) In accordance with Regulation (9) In accordance with Regulation [European Union Recovery Instrument] [European Union Recovery Instrument] and within the limits of resources allocated and within the limits of resources allocated therein, recovery and resilience measures therein, recovery and resilience measures under the Programme should be carried out under the Programme should be carried out to address the unprecedented impact of the to address the unprecedented impact of the COVID-19 crisis. Such additional COVID-19 crisis and ensure that resilient resources should be used in such a way as healthcare and health systems are in to ensure compliance with the time limits place in preparation for future pandemics provided for in Regulation [European and other health crises. Full advantage Union Recovery Instrument]. should be taken of the opportunities that digitalisation, artificial intelligence, robotics and new innovative technologies, in health and care can provide while ensuring the security of data, the right to privacy and data protection, while deploying adequate resources to ensure protection against cyber threats. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument].

Or. en

Amendment 161 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 9

Text proposed by the Commission Amendment

(9) In accordance with Regulation (9) In accordance with Regulation [European Union Recovery Instrument] [European Union Recovery Instrument] and within the limits of resources allocated and within the limits of resources allocated therein, recovery and resilience measures therein, recovery and resilience measures under the Programme should be carried out under the Programme should be carried out

AM\1207705EN.docx 35/276 PE653.822v01-00 EN to address the unprecedented impact of the to address the unprecedented impact of the COVID-19 crisis. Such additional COVID-19 crisis and ensure that resilient resources should be used in such a way as and responsive healthcare and public to ensure compliance with the time limits health systems are in place in preparation provided for in Regulation [European for future pandemics and other cross- Union Recovery Instrument]. border health crises. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument].

Or. en

Amendment 162 Cristian-Silviu Buşoi

Proposal for a regulation Recital 9

Text proposed by the Commission Amendment

(9) In accordance with Regulation (9) In accordance with Regulation [European Union Recovery Instrument] [European Union Recovery Instrument] and within the limits of resources allocated and within the limits of resources allocated therein, recovery and resilience measures therein, recovery and resilience measures under the Programme should be carried out under the Programme should be carried out to address the unprecedented impact of the to address the unprecedented impact of the COVID-19 crisis. Such additional COVID-19 crisis and ensure that resilient resources should be used in such a way as and responsive healthcare and public to ensure compliance with the time limits health systems are in place in preparation provided for in Regulation [European for future pandemics and other health Union Recovery Instrument]. crises. Such additional resources should be used in such a way as to ensure compliance with the time limits provided for in Regulation [European Union Recovery Instrument].

Or. en

Amendment 163 Joanna Kopcińska

Proposal for a regulation Recital 9

PE653.822v01-00 36/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(9) In accordance with Regulation (9) In accordance with Regulation [European Union Recovery Instrument] [European Union Recovery Instrument] and within the limits of resources allocated and within the limits of resources allocated therein, recovery and resilience measures therein, recovery and resilience measures under the Programme should be carried out under the Programme should be carried out to address the unprecedented impact of the to address the unprecedented impact of the COVID-19 crisis. Such additional COVID-19 crisis and ensure that resilient resources should be used in such a way as health care systems and services are in to ensure compliance with the time limits place. Such additional resources should be provided for in Regulation [European used in such a way as to ensure compliance Union Recovery Instrument]. with the time limits provided for in Regulation [European Union Recovery Instrument].

Or. en

Amendment 164 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Chrysoula Zacharopoulou, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level to address different aspects of such threats. With a different aspects of such threats. With a view to strengthen the capability in the view to strengthen the capability in the Union to prepare for, respond to and Union to prepare for, respond to and manage health crisis the Programme manage any future sanitary crises, the should provide support to the actions taken Programme should provide support to the in the framework of the mechanisms and actions taken in the framework of the structures established under Decision No mechanisms and structures established 1082/2013/EU of the European Parliament under Decision No 1082/2013/EU of the and of the Council10 and other relevant European Parliament and of the Council mechanisms and structures established at and other relevant mechanisms and Union level. This could include strategic structures established at Union level. The stockpiling of essential medical supplies or revision of Decision No 1082/2013/EU capacity building in crisis response, could initiate strategic stockpiling of preventive measures related to vaccination essential medical supplies, in addition to

AM\1207705EN.docx 37/276 PE653.822v01-00 EN and immunisation, strengthened the reactive reserve created under RescEU surveillance programmes. In this context during the Covid-19 pandemic, or capacity the Programme should foster Union-wide building in crisis response, preventive and cross-sectoral crisis prevention, measures related to vaccination and preparedness, surveillance, management immunisation, strengthened surveillance and response capacity of actors at the programmes. This revision could also Union, national, regional and local level, introduce the creation of a European including contingency planning and Health Response Mechanism to respond preparedness exercises, in keeping with the to all types of health crises (infectious, “One Health” approach. It should facilitate chemical, environmental, biological, food, the setting up of an integrated cross-cutting nuclear), to strengthen operational risk communication framework working in coordination at European level and to all phases of a health crisis - prevention, monitor the constitution and the preparedness and response. triggering of the strategic reserve of medicines and medical equipment and ensure its proper functioning. 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 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Or. en

Amendment 165 Joanna Kopcińska

Proposal for a regulation Recital 10

PE653.822v01-00 38/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level to address different aspects of such threats. With a different aspects of such threats. With a view to strengthen the capability in the view to strengthen the capability in the Union to prepare for, respond to and Union to prepare for, respond to and manage health crisis the Programme should manage health crisis the Programme should provide support to the actions taken in the provide support to the actions taken in the framework of the mechanisms and framework of the mechanisms and structures established under Decision No structures established under Decision No 1082/2013/EU of the European Parliament 1082/2013/EU of the European Parliament and of the Council10 and other relevant and of the Council10 and other relevant mechanisms and structures established at mechanisms and structures established at Union level. This could include strategic Union level. This could include creating stockpiling of essential medical supplies or strategic reserves of essential medical capacity building in crisis response, supplies or advancing capacity building preventive measures related to vaccination initiatives in crisis response at the Member and immunisation, strengthened State level, preventive measures related to surveillance programmes. In this context vaccination and immunisation, and the Programme should foster Union-wide strengthened surveillance programmes. In and cross-sectoral crisis prevention, this context the Programme should foster preparedness, surveillance, management Union-wide and cross-sectoral crisis and response capacity of actors at the prevention, preparedness, surveillance, Union, national, regional and local level, management and response capacity of including contingency planning and actors at the Union, national, regional and preparedness exercises, in keeping with the local level, including contingency planning “One Health” approach. It should facilitate and preparedness exercises, in keeping the setting up of an integrated cross-cutting with the “One Health” approach, which risk communication framework working in reflects the fact that the health of people, all phases of a health crisis - prevention, animals and the environment are preparedness and response. interconnected and that diseases can be transmitted from people to animals and vice versa. 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 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

AM\1207705EN.docx 39/276 PE653.822v01-00 EN Or. en

Amendment 166 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) COVID-19 has demonstrated the border health threats, the Programme inter-dependencies between human health should support coordinated public health and the health of our planet and our measures at Union level to address vulnerabilities. The emergence of zoonotic different aspects of such threats. With a diseases which are transmitted from view to strengthen the capability in the animals to humans is exacerbated by Union to prepare for, respond to and anthropogenic climate change, the manage health crisis the Programme should destruction of biodiversity and provide support to the actions taken in the environmental degradation. Due to the framework of the mechanisms and serious nature of cross-border health structures established under Decision No threats, the Programme should support 1082/2013/EU of the European Parliament coordinated public health measures at and of the Council10 and other relevant Union level to address different aspects of mechanisms and structures established at such threats. With a view to strengthen the Union level. This could include strategic capability in the Union to prepare for, stockpiling of essential medical supplies or respond to and manage health crisis the capacity building in crisis response, Programme should provide support to the preventive measures related to vaccination actions taken in the framework of the and immunisation, strengthened mechanisms and structures established surveillance programmes. In this context under Decision No 1082/2013/EU of the the Programme should foster Union-wide European Parliament and of the Council10 and cross-sectoral crisis prevention, and other relevant mechanisms and preparedness, surveillance, management structures established at Union level. This and response capacity of actors at the could include strategic stockpiling of Union, national, regional and local level, essential medical supplies or capacity including contingency planning and building in crisis response, preventive preparedness exercises, in keeping with the measures related to vaccination and “One Health” approach. It should facilitate immunisation, strengthened surveillance the setting up of an integrated cross-cutting programmes. In this context the risk communication framework working in Programme should foster Union-wide and all phases of a health crisis - prevention, cross-sectoral crisis prevention, preparedness and response. preparedness, surveillance, management and response capacity of actors at the Union, national, regional and local level, including contingency planning and

PE653.822v01-00 40/276 AM\1207705EN.docx EN 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 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Or. en

Amendment 167 Sirpa Pietikäinen

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level to address different aspects of such threats. With a different aspects of such threats. With a view to strengthen the capability in the view to strengthen the capability in the Union to prepare for, respond to and Union to prepare for, respond to and manage health crisis the Programme should manage health crisis the Programme should provide support to the actions taken in the provide support to the actions taken in the framework of the mechanisms and framework of the mechanisms and structures established under Decision No structures established under Decision No 1082/2013/EU of the European Parliament 1082/2013/EU of the European Parliament and of the Council10 and other relevant and of the Council10 and other relevant mechanisms and structures established at mechanisms and structures established at Union level. This could include strategic Union level. This could include strategic stockpiling of essential medical supplies or stockpiling of essential medical supplies or capacity building in crisis response, capacity building in crisis response, preventive measures related to vaccination preventive measures related to vaccination and immunisation, strengthened and immunisation, strengthened surveillance programmes. In this context surveillance programmes. In this context the Programme should foster Union-wide the Programme should foster Union-wide and cross-sectoral crisis prevention, and cross-sectoral crisis prevention, preparedness, surveillance, management preparedness, surveillance, management

AM\1207705EN.docx 41/276 PE653.822v01-00 EN and response capacity of actors at the and response capacity of actors at the Union, national, regional and local level, Union, national, regional and local level, including contingency planning and including contingency planning and preparedness exercises, in keeping with the preparedness exercises, in keeping with the “One Health” approach. It should facilitate “One Health” approach. It should facilitate the setting up of an integrated cross-cutting the setting up of an integrated cross-cutting risk communication framework working in risk communication framework working in all phases of a health crisis - prevention, all phases of a health crisis - prevention, preparedness and response. preparedness and response. Further developing the common European crisis preparedness, strategically sufficient manufacturing and stockpiling is essential. ______10 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Or. en

Amendment 168 Michèle Rivasi

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level to address different aspects of such threats. With a different aspects of such threats. With a view to strengthen the capability in the view to strengthen the capability in the Union to prepare for, respond to and Union to prepare for, respond to and manage health crisis the Programme should manage health crisis the Programme should provide support to the actions taken in the provide support to the actions taken in the framework of the mechanisms and framework of the mechanisms and structures established under Decision No structures established under Decision No 1082/2013/EU of the European Parliament 1082/2013/EU of the European Parliament and of the Council10 and other relevant and of the Council10 and other relevant mechanisms and structures established at mechanisms and structures established at Union level. This could include strategic Union level. This could include creating stockpiling of essential medical supplies or strategic reserves of essential medical

PE653.822v01-00 42/276 AM\1207705EN.docx EN capacity building in crisis response, supplies or capacity building in crisis preventive measures related to vaccination response, preventive measures related to and immunisation, strengthened vaccination, and immunisation and health surveillance programmes. In this context promotion, strengthened surveillance the Programme should foster Union-wide programmes, platforms to share best and cross-sectoral crisis prevention, practices from conventional and preparedness, surveillance, management integrative medical approaches. In this and response capacity of actors at the context the Programme should foster Union, national, regional and local level, Union-wide and cross-sectoral crisis including contingency planning and prevention, preparedness, surveillance, preparedness exercises, in keeping with the management and response capacity of “One Health” approach. It should facilitate actors at the Union, national, regional and the setting up of an integrated cross-cutting local level, including contingency planning risk communication framework working in and preparedness exercises, in keeping all phases of a health crisis - prevention, with the “One Health” approach. It should preparedness and response. 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 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Or. en

Amendment 169 Véronique Trillet-Lenoir, Stéphane Bijoux

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level to address different aspects of such threats. With a different aspects of such threats. With a view to strengthening the capability in the view to strengthening the capability in the Union to prepare for, respond to and Union to prepare for, respond to and manage health crisis the Programme should manage health crisis the Programme should provide support to the actions taken in the provide support to the actions taken in the

AM\1207705EN.docx 43/276 PE653.822v01-00 EN framework of the mechanisms and framework of the mechanisms and structures established under Decision No structures established under Decision No 1082/2013/EU of the European Parliament 1082/2013/EU of the European Parliament and of the Council10 and other relevant and of the Council10 and other relevant mechanisms and structures established at mechanisms and structures established at Union level. This could include strategic Union level. This could include strategic stockpiling of essential medical supplies or stockpiling of essential medical supplies or capacity building in crisis response, capacity building in crisis response, preventive measures related to vaccination preventive measures related to vaccination and immunisation, strengthened and immunisation, strengthened surveillance programmes. In this context surveillance programmes. In this context the Programme should foster Union-wide the Programme should foster Union-wide, and cross-sectoral crisis prevention, including in the outermost regions and preparedness, surveillance, management the overseas countries and territories, and and response capacity of actors at the cross-sectoral crisis prevention, Union, national, regional and local level, preparedness, surveillance, management including contingency planning and and response capacity of actors at the preparedness exercises, in keeping with the Union, national, regional and local level, ‘One Health’ approach. It should facilitate including contingency planning and the setting up of an integrated cross-cutting preparedness exercises, in keeping with the risk communication framework working in ‘One Health’ approach. It should facilitate all phases of a health crisis - prevention, the setting up of an integrated cross-cutting preparedness and response. risk communication framework working in all phases of a health crisis - prevention, preparedness and response. ______10 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Or. fr

Amendment 170 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level to address

PE653.822v01-00 44/276 AM\1207705EN.docx EN different aspects of such threats. With a different aspects of such threats. With a view to strengthen the capability in the view to strengthen the capability in the Union to prepare for, respond to and Union to prepare for, respond to and manage health crisis the Programme should manage health crisis the Programme should provide support to the actions taken in the provide support to the actions taken in the framework of the mechanisms and framework of the mechanisms and structures established under Decision No structures established under Decision No 1082/2013/EU of the European Parliament 1082/2013/EU of the European Parliament and of the Council10 and other relevant and of the Council10 and other relevant mechanisms and structures established at mechanisms and structures established at Union level. This could include strategic Union level. This could include strategic stockpiling of essential medical supplies or stockpiling of essential medical supplies in capacity building in crisis response, addition to the reactive reserve created preventive measures related to vaccination under rescEU during the Covid-19 and immunisation, strengthened pandemic or capacity building in crisis surveillance programmes. In this context response, preventive measures related to the Programme should foster Union-wide vaccination and immunisation, and cross-sectoral crisis prevention, strengthened surveillance programmes. In preparedness, surveillance, management this context the Programme should foster and response capacity of actors at the Union-wide and cross-sectoral crisis Union, national, regional and local level, prevention, preparedness, surveillance, including contingency planning and management and response capacity of preparedness exercises, in keeping with the actors at the Union, national, regional and “One Health” approach. It should facilitate local level, including contingency planning the setting up of an integrated cross-cutting and preparedness exercises, in keeping risk communication framework working in with the “One Health” approach. It should all phases of a health crisis - prevention, facilitate the setting up of an integrated preparedness and response. cross-cutting risk communication framework working in all phases of a health crisis - prevention, preparedness and response. ______10 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Or. en

Amendment 171 Pascal Arimont, Cindy Franssen, Esther de Lange

Proposal for a regulation Recital 10

AM\1207705EN.docx 45/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level as well as at different aspects of such threats. With a regional level between regions which view to strengthen the capability in the share a common border to address Union to prepare for, respond to and different aspects of such threats. With a manage health crisis the Programme should view to strengthen the capability in the provide support to the actions taken in the Union to prepare for, respond to and framework of the mechanisms and manage health crisis the Programme should structures established under Decision No provide support to the actions taken in the 1082/2013/EU of the European Parliament framework of the mechanisms and and of the Council10 and other relevant structures established under Decision No mechanisms and structures established at 1082/2013/EU of the European Parliament Union level. This could include strategic and of the Council10 and other relevant stockpiling of essential medical supplies or mechanisms and structures established at capacity building in crisis response, Union level. This could include strategic preventive measures related to vaccination stockpiling of essential medical supplies or and immunisation, strengthened capacity building in crisis response, surveillance programmes. In this context preventive measures related to vaccination the Programme should foster Union-wide and immunisation, strengthened and cross-sectoral crisis prevention, surveillance programmes. In this context preparedness, surveillance, management the Programme should foster Union-wide and response capacity of actors at the and cross-sectoral crisis prevention, Union, national, regional and local level, preparedness, surveillance, management including contingency planning and and response capacity of actors at the preparedness exercises, in keeping with the Union, national, regional and local level, “One Health” approach. It should facilitate including contingency planning and the setting up of an integrated cross-cutting preparedness exercises, in keeping with the risk communication framework working in “One Health” approach. It should facilitate all phases of a health crisis - prevention, the setting up of an integrated cross-cutting preparedness and response. risk communication framework working in all phases of a health crisis - prevention, preparedness and response. ______10 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Or. en

PE653.822v01-00 46/276 AM\1207705EN.docx EN Amendment 172 Mick Wallace, Clare Daly

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level to address different aspects of such threats. With a different aspects of such threats. With a view to strengthen the capability in the view to strengthen the capability in the Union to prepare for, respond to and Union to prepare for, respond to and manage health crisis the Programme should manage all aspects of a health crisis in a provide support to the actions taken in the holistic manner, the Programme should framework of the mechanisms and provide support to the actions taken in the structures established under Decision No framework of the mechanisms and 1082/2013/EU of the European Parliament structures established under Decision No and of the Council10 and other relevant 1082/2013/EU of the European Parliament mechanisms and structures established at and of the Council10 and other relevant Union level. This could include strategic mechanisms and structures established at stockpiling of essential medical supplies or Union level. This could include strategic capacity building in crisis response, stockpiling of essential medical supplies or preventive measures related to vaccination capacity building in crisis response, and immunisation, strengthened preventive measures related to health surveillance programmes. In this context education and information, vaccination the Programme should foster Union-wide and immunisation, strengthened and cross-sectoral crisis prevention, surveillance programmes. In this context preparedness, surveillance, management the Programme should foster Union-wide and response capacity of actors at the and cross-sectoral crisis prevention, Union, national, regional and local level, preparedness, surveillance, management including contingency planning and and response capacity of actors at the preparedness exercises, in keeping with the Union, national, regional and local level, “One Health” approach. It should facilitate including contingency planning and the setting up of an integrated cross-cutting preparedness exercises, in keeping with the risk communication framework working in “One Health” approach. It should facilitate all phases of a health crisis - prevention, the setting up of an integrated cross-cutting preparedness and response. risk communication framework working in all phases of a health crisis - prevention, preparedness and response. ______10 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

AM\1207705EN.docx 47/276 PE653.822v01-00 EN Or. en

Amendment 173 Adam Jarubas

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level to address different aspects of such threats. With a different aspects of such threats. With a view to strengthen the capability in the view to strengthen the capability in the Union to prepare for, respond to and Union to prepare for, respond to and manage health crisis the Programme should manage health crisis the Programme should provide support to the actions taken in the provide support to the actions taken in the framework of the mechanisms and framework of the mechanisms and structures established under Decision No structures established under Decision No 1082/2013/EU of the European Parliament 1082/2013/EU of the European Parliament and of the Council10 and other relevant and of the Council10 and other relevant mechanisms and structures established at mechanisms and structures established at Union level. This could include strategic Union level. This could include strategic, stockpiling of essential medical supplies or EU financed and coordinated, stockpiling capacity building in crisis response, of essential medical supplies or capacity preventive measures related to vaccination building in crisis response, preventive and immunisation, strengthened measures related to vaccination and surveillance programmes. In this context immunisation, strengthened surveillance the Programme should foster Union-wide programmes. In this context the and cross-sectoral crisis prevention, Programme should foster Union-wide and preparedness, surveillance, management cross-sectoral crisis prevention, and response capacity of actors at the preparedness, surveillance, management Union, national, regional and local level, and response capacity of actors at the including contingency planning and Union, national, regional and local level, preparedness exercises, in keeping with the including contingency planning and “One Health” approach. It should facilitate preparedness exercises, in keeping with the the setting up of an integrated cross-cutting “One Health” approach. It should facilitate risk communication framework working in the setting up of an integrated cross-cutting all phases of a health crisis - prevention, risk communication framework working in preparedness and response. all phases of a health crisis - prevention, preparedness and response. ______10 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of

PE653.822v01-00 48/276 AM\1207705EN.docx EN 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Or. en

Amendment 174 Jessica Polfjärd

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level to address different aspects of such threats. With a different aspects of such threats. With a view to strengthen the capability in the view to strengthen the capability in the Union to prepare for, respond to and Union to prepare for, respond to and manage health crisis the Programme should manage health crisis the Programme should provide support to the actions taken in the provide support to the actions taken in the framework of the mechanisms and framework of the mechanisms and structures established under Decision No structures established under Decision No 1082/2013/EU of the European Parliament 1082/2013/EU of the European Parliament and of the Council10 and other relevant and of the Council10 and other relevant mechanisms and structures established at mechanisms and structures established at Union level. This could include strategic Union level. This could include strategic stockpiling of essential medical supplies or and proportionate reserves of essential capacity building in crisis response, medical supplies or capacity building in preventive measures related to vaccination crisis response, preventive measures and immunisation, strengthened related to vaccination and immunisation, surveillance programmes. In this context strengthened surveillance programmes. In the Programme should foster Union-wide this context the Programme should foster and cross-sectoral crisis prevention, Union-wide and cross-sectoral crisis preparedness, surveillance, management prevention, preparedness, surveillance, and response capacity of actors at the management and response capacity of Union, national, regional and local level, actors at the Union, national, regional and including contingency planning and local level, including contingency planning preparedness exercises, in keeping with the and preparedness exercises, in keeping “One Health” approach. It should facilitate with the “One Health” approach. It should the setting up of an integrated cross-cutting facilitate the setting up of an integrated risk communication framework working in cross-cutting risk communication all phases of a health crisis - prevention, framework working in all phases of a preparedness and response. health crisis - prevention, preparedness and

AM\1207705EN.docx 49/276 PE653.822v01-00 EN response. ______10 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Or. en

Amendment 175 Nathalie Colin-Oesterlé

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level to address different aspects of such threats. With a different aspects of such threats. With a view to strengthening the capability in the view to strengthening the capability in the Union to prepare for, respond to and Union to prepare for, respond to and manage health crisis the Programme should manage health crisis the Programme should provide support to the actions taken in the provide support to the actions taken in the framework of the mechanisms and framework of the mechanisms and structures established under Decision No structures established under Decision No 1082/2013/EU of the European Parliament 1082/2013/EU of the European Parliament and of the Council10 and other relevant and of the Council and other relevant mechanisms and structures established at mechanisms and structures established at Union level. This could include strategic Union level. This could include European stockpiling of essential medical supplies or strategic stockpiling of essential medical capacity building in crisis response, supplies or capacity building in crisis preventive measures related to vaccination response, preventive measures related to and immunisation, strengthened vaccination and immunisation, surveillance programmes. In this context strengthened surveillance programmes. In the Programme should foster Union-wide this context the Programme should foster and cross-sectoral crisis prevention, Union-wide and cross-sectoral crisis preparedness, surveillance, management prevention, preparedness, surveillance, and response capacity of actors at the management and response capacity of Union, national, regional and local level, actors at the Union, national, regional and including contingency planning and local level, including contingency planning preparedness exercises, in keeping with the and preparedness exercises, in keeping ‘One Health’ approach. It should facilitate with the ‘One Health’ approach. It should

PE653.822v01-00 50/276 AM\1207705EN.docx EN the setting up of an integrated cross-cutting facilitate the setting up of an integrated risk communication framework working in cross-cutting risk communication all phases of a health crisis - prevention, framework working in all phases of a preparedness and response. health crisis - prevention, preparedness and response. ______10 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Or. fr

Amendment 176 Cristian-Silviu Buşoi

Proposal for a regulation Recital 10

Text proposed by the Commission Amendment

(10) Due to the serious nature of cross- (10) Due to the serious nature of cross- border health threats, the Programme border health threats, the Programme should support coordinated public health should support coordinated public health measures at Union level to address measures at Union level to address different aspects of such threats. With a different aspects of such threats. With a view to strengthen the capability in the view to strengthen the capability in the Union to prepare for, respond to and Union to prepare for, respond to and manage health crisis the Programme should manage health crisis the Programme should provide support to the actions taken in the provide support to the actions taken in the framework of the mechanisms and framework of the mechanisms and structures established under Decision No structures established under Decision No 1082/2013/EU of the European Parliament 1082/2013/EU of the European Parliament and of the Council10 and other relevant and of the Council10 and other relevant mechanisms and structures established at mechanisms and structures established at Union level. This could include strategic Union level. This could include strategic stockpiling of essential medical supplies or EU reserve of essential medical supplies or capacity building in crisis response, capacity building in crisis response, preventive measures related to vaccination preventive measures related to vaccination and immunisation, strengthened and immunisation, strengthened surveillance programmes. In this context surveillance programmes. In this context the Programme should foster Union-wide the Programme should foster Union-wide and cross-sectoral crisis prevention, and cross-sectoral crisis prevention, preparedness, surveillance, management preparedness, surveillance, management and response capacity of actors at the and response capacity of actors at the

AM\1207705EN.docx 51/276 PE653.822v01-00 EN Union, national, regional and local level, Union, national, regional and local level, including contingency planning and including contingency planning and preparedness exercises, in keeping with the preparedness exercises, in keeping with the “One Health” approach. It should facilitate “One Health” approach. It should facilitate the setting up of an integrated cross-cutting the setting up of an integrated cross-cutting risk communication framework working in risk communication framework working in all phases of a health crisis - prevention, all phases of a health crisis - prevention, preparedness and response. preparedness and response. ______10 Decision No 1082/2013/EU of the 10 Decision No 1082/2013/EU of the European Parliament and of the Council of European Parliament and of the Council of 22 October 2013 on serious cross-border 22 October 2013 on serious cross-border threats to health and repealing Decision No threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

Or. en

Amendment 177 Nathalie Colin-Oesterlé

Proposal for a regulation Recital 10 a (new)

Text proposed by the Commission Amendment

(10a) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices and personal protective equipment needed in the Union during the pandemics. In the event of health crises and pandemics, but also for recurrent shortages, the Programme should promote actions that encourage the production, purchase and management of relevant products by ensuring that they complement other EU instruments.

Or. fr

Amendment 178 Sirpa Pietikäinen

PE653.822v01-00 52/276 AM\1207705EN.docx EN Proposal for a regulation Recital 10 a (new)

Text proposed by the Commission Amendment

(10a) To combat serious threats to the health of European citizens we need to establish communicable diseases regulation. Communicable diseases move freely within whole EU. In more complex and globalised world, the ability to respond to the challenges clearly requires a common regulation to face and tackle the border crossing diseases on EU level. Individual Member States cannot face these global challenges alone.

Or. en

Amendment 179 Mick Wallace, Clare Daly

Proposal for a regulation Recital 10 a (new)

Text proposed by the Commission Amendment

(10a) Given the impact that the COVID- 19 crisis had on access to healthcare services, which may not be directly related to the treatment of COVID-19 infections but remain essential healthcare services, including sexual and reproductive healthcare services, the Programme should respond to health crises in a holistic manner and support actions that aim to guarantee access to all essential healthcare services.

Or. en

Amendment 180 Kateřina Konečná

AM\1207705EN.docx 53/276 PE653.822v01-00 EN Proposal for a regulation Recital 11

Text proposed by the Commission Amendment

(11) As in the time of health crisis (11) In the time of health crisis emergency health technology assessment emergency Clinical Trials and Health as well as clinical trials can contribute to Technology Assessment (HTA) can the rapid development of medical contribute to the rapid development, countermeasures the Programme should identification and availability of medical provide support to facilitate such actions. countermeasures. The Commission has The Commission has adopted a proposal11 presented, in January 2018, a Proposal on Health Technology Assessment (HTA) for a Regulation to support cooperation to support cooperation on health on HTA at Union level. The European technology assessment at Union level. Parliament already provided its position expressing a large support for the Proposal, which is awaiting the position and approval of the European Council. A cooperation among Member States has been running for more than 20 years on a voluntary basis. The Commission Proposal aims at making this coordination fully operational and sustainable under the EU budget. The Proposal profiles the creation of a permanent secretariat (also known as Coordination Group) to support Member States cooperation in the timely identification and assessment of relevant health technologies, so as to ensure the necessary transparency and consistency on the medical and scientific information to be made available to Member States, with the due involvement of experts and patients. The programme should provide support to facilitate such actions, including the creation of a scientific committee to advise the HTA Coordination Group of Member States on the technologies which are meant to benefit the most from a common assessment. Medical and scientific evidence must override any national administrations’ political or industrial interests. ______11 Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and

PE653.822v01-00 54/276 AM\1207705EN.docx EN amending Directive 2011/24/EU, COM(2018) 51 final of 31.01. 2018.

Or. en

Justification

The importance of HTA for a European integrated health system obliges us to remind the importance of the Commission Proposal, approved by the Parliament and blocked in the Council. The Amendment reminds the terms and the conditions of the Proposal, including transparency, evidence-based medicine, patient engagement, and calls for support by this programme.

Amendment 181 Joanna Kopcińska

Proposal for a regulation Recital 11

Text proposed by the Commission Amendment

(11) As in the time of health crisis (11) In the context of public health emergency health technology assessment crises, health technology assessment and as well as clinical trials can contribute to clinical trials can contribute to the rapid the rapid development of medical development of medical countermeasures, countermeasures the Programme should and the Programme should provide support provide support to facilitate such actions. to facilitate such actions. The Commission The Commission has adopted a proposal11 has adopted a proposal11 on HTA to on Health Technology Assessment (HTA) support cooperation on health technology to support cooperation on health assessment at Union level. Notes, however, technology assessment at Union level. that there has been limited progress on the proposal in Council as some Member States have challenged its compatibility with the subsidiarity principle and objected to the mandatory uptake of joint HTA reports. ______11 Proposal for a Regulation of the 11 Proposal for a Regulation of the European Parliament and of the Council on European Parliament and of the Council on health technology assessment and health technology assessment and amending Directive 2011/24/EU, amending Directive 2011/24/EU, COM(2018) 51 final of 31.01. 2018. COM(2018) 51 final of 31.01. 2018.

Or. en

AM\1207705EN.docx 55/276 PE653.822v01-00 EN Amendment 182 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Recital 11

Text proposed by the Commission Amendment

(11) As in the time of health crisis (11) As in the time of health crisis emergency health technology assessment emergency health technology assessment as well as clinical trials can contribute to as well as clinical trials can contribute to the rapid development of medical the rapid development of medical countermeasures the Programme should countermeasures the Programme should provide support to facilitate such actions. provide support to facilitate such actions. The Commission has adopted a proposal11 The Commission has adopted a proposal11 on Health Technology Assessment (HTA) on HTA to support cooperation on health to support cooperation on health technology assessment at Union level. On technology assessment at Union level. 14 February 2019, the European Parliament also adopted its legislative resolution at first reading. ______11 Proposal for a Regulation of the 11 Proposal for a Regulation of the European Parliament and of the Council on European Parliament and of the Council on health technology assessment and health technology assessment and amending Directive 2011/24/EU, amending Directive 2011/24/EU, COM(2018) 51 final of 31.01. 2018. COM(2018) 51 final of 31.01. 2018.

Or. en

Amendment 183 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Chrysoula Zacharopoulou, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 11

Text proposed by the Commission Amendment

(11) As in the time of health crisis (11) As in the time of health crisis emergency health technology assessment emergency health technology assessment as well as clinical trials can contribute to as well as clinical trials can contribute to the rapid development of medical the rapid development of medical countermeasures the Programme should countermeasures the Programme should provide support to facilitate such actions. provide support to facilitate such actions. The Commission has adopted a proposal11 The Commission has adopted a proposal11

PE653.822v01-00 56/276 AM\1207705EN.docx EN on Health Technology Assessment (HTA) on HTA to support cooperation on health to support cooperation on health technology assessment at Union level. The technology assessment at Union level. Council should adopt a common position and start the negotiations with the Parliament on this proposal. ______11 Proposal for a Regulation of the 11 Proposal for a Regulation of the European Parliament and of the Council on European Parliament and of the Council on health technology assessment and health technology assessment and amending Directive 2011/24/EU, amending Directive 2011/24/EU, COM(2018) 51 final of 31.01. 2018. COM(2018) 51 final of 31.01. 2018.

Or. en

Amendment 184 Cristian-Silviu Buşoi

Proposal for a regulation Recital 12

Text proposed by the Commission Amendment

(12) With a view to protect people in (12) With a view to protect people in vulnerable situations, including those vulnerable situations, including those suffering from mental illnesses and chronic suffering from mental illnesses, living with diseases, the Programme should also or most affected by communicable or non- promote actions which address the communicable diseases and chronic collateral impacts of the health crisis on diseases, the Programme should also people belonging to such vulnerable promote actions which address the groups. collateral impacts of the health crisis on people belonging to such vulnerable groups, including improving health literacy and supporting patient advocacy groups. With a view to guaranteeing continued high standards of essential healthcare services, including prevention, the Programme should, in particular in times of crisis and pandemics, encourage a transition to accessible and affordable telemedicine, at-home administration of medication and implementation of preventative and self-care plans, where possible and appropriate, while ensuring that access to healthcare and prevention services is provided to chronic patients and patients at risk. The Programme

AM\1207705EN.docx 57/276 PE653.822v01-00 EN should also ensure that the transition is based on evidence and evaluation of best practices, supported by adequate systems of information and health literacy, infrastructures and careful planning, taking into consideration issues such as access to digital solutions in remote areas or for specific population groups.

Or. en

Amendment 185 Kateřina Konečná

Proposal for a regulation Recital 12

Text proposed by the Commission Amendment

(12) With a view to protect people in (12) With a view to protect people in vulnerable situations, including those vulnerable situations, including those suffering from mental illnesses and chronic suffering from mental illnesses, non- diseases, the Programme should also communicable diseases and chronic promote actions which address the diseases, the Programme should also collateral impacts of the health crisis on promote actions which address the people belonging to such vulnerable collateral impacts of the health crisis on groups. people belonging to such vulnerable groups. With a view to guaranteeing continued high standards of essential healthcare services, the Programme should, in particular in times of crisis and pandemics, encourage a transition to telemedicine, at-home administration of medication and implementation of preventative and self-care plans, where possible and appropriate, while ensuring that access to healthcare services is provided to chronic patients. The Programme should also ensure that the transition is based on evidence and evaluation of best practices, supported by adequate systems of information and health literacy, infrastructures and careful planning, taking into consideration issues such as access to digital solutions in remote areas or for

PE653.822v01-00 58/276 AM\1207705EN.docx EN specific population groups.

Or. en

Justification

The COVID-19 crisis revealed once again already existing gaps and weaknesses in our health systems and pushed for the adoption, at least in some cases, of innovative solutions to improve care for patients. However, it will be now fundamental to turn attention to a more systematic strengthening of our health systems, taking into consideration evaluation of best practices – both digital and organisational – adopted during the crisis, evidence-based approach and a more thorough consideration of broader systemic issues.

Amendment 186 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Christel Schaldemose

Proposal for a regulation Recital 12

Text proposed by the Commission Amendment

(12) With a view to protect people in (12) With a view to protect people in vulnerable situations, including those vulnerable situations, such as the elderly, suffering from mental illnesses and children, Roma, migrants, and people chronic diseases, the Programme should living in a socioeconomically precarious also promote actions which address the situation, amongst others, including those collateral impacts of the health crisis on suffering from non-communicable people belonging to such vulnerable diseases, such as cardiovascular diseases, groups. cancer, respiratory diseases, diabetes and mental illnesses amongst others, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups. The crisis has revealed that e-health and telemedicine have room to increase and improve the healthcare services and health coverage in a more efficient way. The programme should increase the e-skills of patients and health professionals, improve e-health infrastructures and services, allowing for more competences to be given to patients for the management of their own health and disease treatment, lightening the burden on the healthcare services and

AM\1207705EN.docx 59/276 PE653.822v01-00 EN increasing their efficiency and availability in responding to demands.

Or. en

Amendment 187 Mick Wallace, Clare Daly

Proposal for a regulation Recital 12

Text proposed by the Commission Amendment

(12) With a view to protect people in (12) With a view to protect people in vulnerable situations, including those vulnerable situations, including people suffering from mental illnesses and chronic with a disadvantaged socio economic diseases, the Programme should also status, women, victims/survivors of sexual promote actions which address the and gender-based violence, LGBTI collateral impacts of the health crisis on people, ethnic minorities, Roma people, people belonging to such vulnerable migrant people, people living with groups. disabilities, suffering from mental illnesses and chronic diseases, and other marginalised, discriminated against, vulnerable, underserved groups, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups. The Programme should therefore support actions which aim to address all social determinants of health including gender with an intersectional approach, with a view of putting an end to all health inequalities including gender- based inequalities, responding to people’s specific health needs including women’s health needs, and aim to ensure continued access to all health care services.

Or. en

Amendment 188 Christian Ehler on behalf of the EPP Group Dan Nica on behalf of the S&D Group

PE653.822v01-00 60/276 AM\1207705EN.docx EN Martina Dlabajová on behalf of the Renew Group Cristian-Silviu Buşoi

Proposal for a regulation Recital 12

Text proposed by the Commission Amendment

(12) With a view to protect people in (12) With a view to protect people in vulnerable situations, including those vulnerable situations, including those suffering from mental illnesses and chronic suffering from mental illnesses and chronic diseases, the Programme should also diseases, the Programme should also promote actions which address the promote actions which address the collateral impacts of the health crisis on collateral impacts of the health crisis on people belonging to such vulnerable people belonging to such vulnerable groups groups. as well as the varying impacts in terms of gender. With a view to guaranteeing continued high standards of essential healthcare services, the Programme should, in particular in times of crisis and pandemics, encourage a transition to telemedicine taking account of varying levels of digital literacy, at-home administration of medication, promote innovative digital solutions for health and care in synergy with Horizon Europe and its relevant Missions and Partnerships and implementation of preventative and self-care plans, where possible and appropriate, while ensuring that access to healthcare services is provided to chronic patients, .

Or. en

Amendment 189 Luisa Regimenti, Joëlle Mélin, Catherine Griset, Danilo Oscar Lancini, Lucia Vuolo, Silvia Sardone, Vincenzo Sofo, Simona Baldassarre, Marco Dreosto, Aurelia Beigneux

Proposal for a regulation Recital 12

Text proposed by the Commission Amendment

(12) With a view to protecting people in (12) With a view to protecting people in vulnerable situations, including those vulnerable situations, including those

AM\1207705EN.docx 61/276 PE653.822v01-00 EN suffering from mental illnesses and chronic suffering from mental illnesses, non- diseases, the Programme should also communicable diseases and chronic promote actions which address the diseases, the Programme should also collateral impacts of the health crisis on promote actions which address the people belonging to such vulnerable collateral impacts of the health crisis on groups. people belonging to such vulnerable groups. With a view to guaranteeing continued high standards of essential healthcare services, the Programme should, especially in times of crisis and pandemics, encourage a transition to telemedicine, home administration of medication, and implementation of preventative and self-care plans, where possible and appropriate, while ensuring that access to healthcare services is provided to chronic patients, taking into account the respective levels of digitisation of the Member States and problems of access to digital solutions in remote areas or for certain population groups.

Or. it

Amendment 190 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 12

Text proposed by the Commission Amendment

(12) With a view to protect people in (12) With a view to protect people in vulnerable situations, including those vulnerable situations, including those suffering from mental illnesses and chronic suffering from mental illnesses and chronic diseases, the Programme should also diseases, the Programme should also promote actions which address the promote actions which address the collateral impacts of the health crisis on collateral impacts of the health crisis on people belonging to such vulnerable people belonging to such vulnerable groups. groups. With a view to guaranteeing continued high standards of essential healthcare services, the Programme should, in particular in times of crisis and pandemics, encourage a transition to accessible and affordable telemedicine, at- home administration of medication and

PE653.822v01-00 62/276 AM\1207705EN.docx EN 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.

Or. en

Amendment 191 Chrysoula Zacharopoulou, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Karen Melchior, Sophia in 't Veld, Samira Rafaela, Hilde Vautmans, Susana Solís Pérez, Maria Noichl

Proposal for a regulation Recital 12

Text proposed by the Commission Amendment

(12) With a view to protect people in (12) With a view to protect vulnerable vulnerable situations, including those populations, including children, elder suffering from mental illnesses and people, socioeconomically disadvantaged chronic diseases, the Programme should people, women, LGBTI people, ethnic also promote actions which address the minorities, people affected by a physical collateral impacts of the health crisis on or mental disability, those suffering from people belonging to such vulnerable chronic diseases, the Programme should groups. also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups, taking into account their specific health needs.

Or. en

Amendment 192 Linea Søgaard-Lidell, Frédérique Ries, Jan Huitema

Proposal for a regulation Recital 12

Text proposed by the Commission Amendment

(12) With a view to protect people in (12) With a view to protect people in vulnerable situations, including those vulnerable situations, including those suffering from mental illnesses and chronic suffering from mental illnesses and chronic

AM\1207705EN.docx 63/276 PE653.822v01-00 EN diseases, the Programme should also diseases, such as obesity, cancer, diabetes, promote actions which address the cardiovascular disease and neurologic collateral impacts of the health crisis on disorder, the Programme should also people belonging to such vulnerable promote actions which address the groups. collateral impacts of the health crisis on people belonging to such vulnerable groups.

Or. en

Amendment 193 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 12

Text proposed by the Commission Amendment

(12) With a view to protect people in (12) With a view to protect vulnerable vulnerable situations, including those populations including children, the suffering from mental illnesses and elderly, pregnant women, people affected chronic diseases, the Programme should by a disability, patients with chronic also promote actions which address the diseases, the Programme should also collateral impacts of the health crisis on promote actions which address the people belonging to such vulnerable collateral impacts of the health crisis and groups. medical products shortages on people belonging to such vulnerable groups.

Or. en

Amendment 194 Mick Wallace, Clare Daly

Proposal for a regulation Recital 12 a (new)

Text proposed by the Commission Amendment

(12a) Article 8 TFEU gives the Union the task of eliminating inequalities and promoting equality between men and women in all of its activities. The principle of gender mainstreaming should

PE653.822v01-00 64/276 AM\1207705EN.docx EN be applied to all activities implemented through this Programme, and this Programme should contribute to achieving the common objectives set out in the Council conclusions on women's health of 22 June 2006. This Programme should support actions which promote gender mainstreaming in healthcare, address women’s specific health needs as some health issues affect women exclusively or disproportionately, including sexual and gender-based violence as well as certain aspects of sexual and reproductive health, address gender aspects of health including sexual and reproductive health and rights as committed to in the Gender Equality Strategy, aim to reduce gender inequalities in health recognizing gender as a key determinant of health, collect disaggregated and gender-specific data on the status of women’s health to measure women’s unmet medical needs, and provide gender-sensitive health information, education and promotion, prevention measures and treatment.

Or. en

Amendment 195 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Recital 12 a (new)

Text proposed by the Commission Amendment

(12a) The right to physical and mental health is a fundamental human right. Every person, without discrimination, has the right to access modern and comprehensive healthcare. The EU4Health programme should guarantee that universal health coverage is provided, in line with the international

AM\1207705EN.docx 65/276 PE653.822v01-00 EN commitments made through SDGs and with WHO policies, and ensure that everyone can use the health services they need without experiencing financial hardship. To continue being a global leader in health and to provide a high standard healthcare across the Union, the Commission should propose a Directive on minimum standards for quality healthcare with a set of criteria that should be reported by Member States, such as hospital beds per capita, critical care capacities, numbers of doctors and nurses per capita, rate of health expenditure and access and affordability of healthcare for all, including for vulnerable people. This would improve patient safety and result in better conditions in healthcare for patients and professionals.

Or. en

Amendment 196 Antoni Comín i Oliveres

Proposal for a regulation Recital 12 a (new)

Text proposed by the Commission Amendment

(12a) Demographic change and technological innovation are some of the most important challenges facing our health systems. The aging of the population is largely due to the success of our healthcare systems and forces them, at the same time, to a structural transformation: from a healthcare model focused mainly on acute diseases, it is necessary to move towards a healthcare model in which chronic diseases gain more weight. It is important that the Member States accompany each other in this process of transformation of the healthcare model, and for this reason it is necessary to strengthen good practices

PE653.822v01-00 66/276 AM\1207705EN.docx EN exchanging mechanisms. TheEU4Health programme should play an important role in guiding these exchanges.

Or. en

Amendment 197 Luisa Regimenti, Joëlle Mélin, Catherine Griset, Simona Baldassarre, Danilo Oscar Lancini, Lucia Vuolo, Silvia Sardone, Vincenzo Sofo, Marco Dreosto, Aurelia Beigneux

Proposal for a regulation Recital 12 a (new)

Text proposed by the Commission Amendment

(12a) Correlations have been observed between health and/or economic crises and a worrying increase in depressive tendencies resulting from the effects of reduced disposable income, uncertainty about the future and growing unemployment. The Programme should therefore provide support for national actions aimed at integrating mental health into all policies and promoting mental health in all areas, including school and work, and for preventive actions to combat depression and suicide.

Or. it

Amendment 198 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 13

Text proposed by the Commission Amendment

(13) The COVID-19 crisis has (13) The COVID-19 crisis has highlighted many challenges in ensuring highlighted many challenges in ensuring the supply of medicines, medical devices the supply of medicines, medical devices as well as personal protective equipment as well as personal protective equipment

AM\1207705EN.docx 67/276 PE653.822v01-00 EN needed in the Union during the pandemics. needed in the Union during the pandemics. The Programme therefore should provide The Programme therefore should provide support to actions which foster the support to actions which foster the production, procurement and management production, procurement, management and of crisis relevant products ensuring distribution of crisis relevant products complementarity with other Union ensuring complementarity with other instruments. Union instruments. The Programme should promote the establishment of a specific Joint Action on the prevention of shortages of medical supply to allow the exchange of good practises between Member States and the development of common prevention measures. The Commission should also present a specific strategy for managing shortages of medicines and medical products in Europe in the framework of its Pharmaceutical Strategy.

Or. en

Amendment 199 Christian Ehler on behalf of the EPP Group Dan Nica on behalf of the S&D Group Martina Dlabajová on behalf of the Renew Group Ville Niinistö on behalf of the Greens/EFA Group Marisa Matias on behalf of the GUE/NGL Group Cristian-Silviu Buşoi

Proposal for a regulation Recital 13

Text proposed by the Commission Amendment

(13) The COVID-19 crisis has (13) The COVID-19 crisis has highlighted many challenges in ensuring highlighted many challenges including the the supply of medicines, medical devices EU’s dependency on third countries in as well as personal protective equipment ensuring the supply of chemical raw and needed in the Union during the pandemics. starting materials, active pharmaceutical The Programme therefore should provide ingredients, medicines, medical devices as support to actions which foster the well as personal protective equipment production, procurement and management needed in the Union during the pandemics.

PE653.822v01-00 68/276 AM\1207705EN.docx EN of crisis relevant products ensuring The Programme therefore should provide complementarity with other Union support to actions which will increase the instruments. security of supply of medicines in the EU and reduce dependency on third countries by encouraging the diversification of supply chains, fostering the production in the EU, joint procurement and management of crisis relevant products ensuring complementarity with other Union instruments.

Or. en

Amendment 200 Nathalie Colin-Oesterlé

Proposal for a regulation Recital 13

Text proposed by the Commission Amendment

(13) The COVID-19 crisis has (13) The COVID-19 crisis has highlighted many challenges in ensuring highlighted our dependence on third the supply of medicines, medical devices countries for the supply of medicines, as well as personal protective equipment medical devices as well as personal needed in the Union during the pandemics. protective equipment needed in the Union The Programme therefore should provide during the pandemics. The Programme support to actions which foster the therefore should enable the Commission production, procurement and management and the Member States to take all the of crisis relevant products ensuring necessary measures to guarantee complementarity with other Union European independence in health instruments. matters, by providing support to actions which foster the production, procurement and management of crisis relevant products ensuring complementarity with other Union instruments.

Or. fr

Amendment 201 Sirpa Pietikäinen

Proposal for a regulation Recital 13

AM\1207705EN.docx 69/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(13) The COVID-19 crisis has (13) The COVID-19 crisis has highlighted many challenges in ensuring highlighted many challenges in ensuring the supply of medicines, medical devices the supply of medicines, medical devices, as well as personal protective equipment active pharmaceutical ingredients, as well needed in the Union during the pandemics. as personal protective equipment needed in The Programme therefore should provide the Union during the pandemics. The support to actions which foster the Programme therefore should provide production, procurement and management support to actions which foster the of crisis relevant products ensuring production, procurement and management complementarity with other Union of crisis relevant products ensuring instruments. complementarity with other Union instruments. Upgradable and scalable manufacturing capacity of medicines within European Union should be achieved, to avoid the hindrances in medicine circulation and shortages in supply.

Or. en

Amendment 202 Joanna Kopcińska

Proposal for a regulation Recital 13

Text proposed by the Commission Amendment

(13) The COVID-19 crisis has (13) The COVID-19 crisis has highlighted many challenges in ensuring highlighted many challenges in ensuring the supply of medicines, medical devices the supply of medicines, medical devices as well as personal protective equipment as well as personal protective equipment needed in the Union during the pandemics. needed in the Union during the pandemics The Programme therefore should provide noting, in particular, its dependency on support to actions which foster the third countries for manufacturing production, procurement and management capacity, the supply of active of crisis relevant products ensuring pharmaceutical ingredients and starting complementarity with other Union materials. The Programme therefore instruments. should provide support to actions which foster the production, procurement and management of crisis relevant products ensuring complementarity with other Union instruments.

PE653.822v01-00 70/276 AM\1207705EN.docx EN Or. en

Amendment 203 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 13

Text proposed by the Commission Amendment

(13) The COVID-19 crisis has (13) The COVID-19 crisis has highlighted many challenges in ensuring highlighted many challenges in ensuring the supply of medicines, medical devices the supply of medicines, medical devices as well as personal protective equipment as well as personal protective equipment needed in the Union during the pandemics. needed in the Union during the pandemics. The Programme therefore should provide The Programme therefore should provide support to actions which foster the support to actions, which foster the production, procurement and management production, procurement and management of crisis relevant products ensuring of medical and care relevant products to complementarity with other Union mitigate the risk of shortages, especially instruments. in times of health crises, ensuring complementarity with other Union instruments.

Or. en

Amendment 204 Mairead McGuinness

Proposal for a regulation Recital 13

Text proposed by the Commission Amendment

(13) The COVID-19 crisis has (13) The COVID-19 crisis has highlighted many challenges in ensuring highlighted many challenges in ensuring the supply of medicines, medical devices the supply of medicines, medical devices as well as personal protective equipment as well as personal protective equipment needed in the Union during the pandemics. needed in the Union during the pandemics. The Programme therefore should provide The Programme therefore should provide support to actions which foster the support to actions which foster the production, procurement and management production, procurement, management, of crisis relevant products ensuring accessibility and affordability of crisis

AM\1207705EN.docx 71/276 PE653.822v01-00 EN complementarity with other Union relevant products ensuring instruments. complementarity with other Union instruments.

Or. en

Amendment 205 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 14

Text proposed by the Commission Amendment

(14) In order to minimise the public (14) In order to minimise the public health consequences of serious cross- health consequences of serious cross- border threats to health it should be border threats to health it should be possible for actions supported under the possible for actions supported under the Programme to cover coordination of the Programme to cover coordination of the activities which strengthen the activities which strengthen the interoperability and coherence of Member interoperability and coherence of Member States’ health-systems through States’ health-systems through benchmarking, cooperation and exchange benchmarking, cooperation and exchange of best practices and ensure their capability of best practices and ensure their capability to respond to health emergencies, that to respond to health emergencies, that includes contingency planning, includes contingency planning, preparedness exercises and the upskilling preparedness exercises and the upskilling of health care and public health staff and of health care and public health staff and the establishment of mechanisms for the the establishment of mechanisms for the efficient monitoring and needs-driven efficient monitoring and needs-driven distribution or allocation of goods and distribution or allocation of goods and services needed in time of crisis. services needed in time of crisis. The benchmarking, cooperation and exchange of best practices should be equally promoted in periods where there are no crises.

Or. en

Amendment 206 Pascal Arimont, Cindy Franssen, Esther de Lange

PE653.822v01-00 72/276 AM\1207705EN.docx EN Proposal for a regulation Recital 14

Text proposed by the Commission Amendment

(14) In order to minimise the public (14) In order to minimise the public health consequences of serious cross- health consequences of serious cross- border threats to health it should be border threats to health it should be possible for actions supported under the possible for actions supported under the Programme to cover coordination of the Programme to cover coordination of the activities which strengthen the activities which strengthen the interoperability and coherence of Member interoperability and coherence of Member States’ health-systems through States’ health-systems through benchmarking, cooperation and exchange benchmarking, cooperation and exchange of best practices and ensure their capability of best practices and ensure their capability to respond to health emergencies, that to respond to health emergencies, that includes contingency planning, includes contingency planning, preparedness exercises and the upskilling preparedness exercises and the upskilling of health care and public health staff and of health care and public health staff and the establishment of mechanisms for the the establishment of mechanisms for the efficient monitoring and needs-driven efficient monitoring and needs-driven distribution or allocation of goods and distribution or allocation of goods and services needed in time of crisis. services needed in time of crisis, which would be particularly beneficial in a cross-border context.

Or. en

Amendment 207 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 14

Text proposed by the Commission Amendment

(14) In order to minimise the public (14) In order to minimise the public health consequences of serious cross- health consequences of serious cross- border threats to health it should be border threats to health it should be possible for actions supported under the possible for actions supported under the Programme to cover coordination of the Programme to cover coordination of the activities which strengthen the activities which strengthen the interoperability and coherence of Member interoperability and coherence of Member States’ health-systems through States’ health-systems through benchmarking, cooperation and exchange benchmarking, cooperation and exchange

AM\1207705EN.docx 73/276 PE653.822v01-00 EN of best practices and ensure their capability of best practices via an increased number to respond to health emergencies, that of Joint Actions and ensure their capability includes contingency planning, to respond to health emergencies, that preparedness exercises and the upskilling includes contingency planning, of health care and public health staff and preparedness exercises and the upskilling the establishment of mechanisms for the of health care and public health staff and efficient monitoring and needs-driven the establishment of mechanisms for the distribution or allocation of goods and efficient monitoring and needs-driven services needed in time of crisis. distribution or allocation of goods and services needed in time of crisis.

Or. en

Amendment 208 Joanna Kopcińska

Proposal for a regulation Recital 14 a (new)

Text proposed by the Commission Amendment

(14a) The evaluation by the Commission of Directive 2011/24/EU of the European Parliament and the Council1a showed that not all Member States implemented the Directive completely. Obstacles to and limitations of the application of the Directive, such as unduly burdensome authorisation requirements or limitations on reimbursement are restricting access to healthcare for citizens whose medical needs might sometimes be better catered for in a Member State other than their own. Moreover, not all Member States are able to supply data or information regarding patients travelling abroad, given that data collection is not always comparable from one Member State to another. The Programme should therefore support full implementation of Directive2011/24/EU, guaranteeing a high level of public health protection while respecting the principle of the free movement of persons within the internal market. ______

PE653.822v01-00 74/276 AM\1207705EN.docx EN 1a 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).

Or. en

Amendment 209 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Andreas Glück, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 14 a (new)

Text proposed by the Commission Amendment

(14a) The COVID-19 crisis has revealed the important need for Member States to organize stress tests to assess the resilience of their national health systems to all types of crises. These tests must be carried out on the basis of precise evaluation criteria set by the European Commission. The results of these tests could determine the weaknesses of the national health systems and the areas to be the subject to specific financial support.

Or. en

Amendment 210 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Andreas Glück, Chrysoula Zacharopoulou, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 14 b (new)

AM\1207705EN.docx 75/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(14b) The coordination between national health systems is essential to guarantee solidarity within the Union. Joint procurement, coordinated transfer of equipment, reserve and circulation of blood products and organs, transports of patients for cross-border care should be adequately anticipated.

Or. en

Amendment 211 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Chrysoula Zacharopoulou, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 14 c (new)

Text proposed by the Commission Amendment

(14c) In addition to an increased budget, the EU Civil Protection Mechanism (UCPM) and its instrument RescEU should be strengthened to ensure a truly common, coordinated and effective response at EU level.

Or. en

Amendment 212 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 14 d (new)

Text proposed by the Commission Amendment

(14d) The Union should be able to rely on the mobilization of health

PE653.822v01-00 76/276 AM\1207705EN.docx EN professionals through the “European Medical Corps” created to enable quick medical assistance and public health expertise to all Member States.

Or. en

Amendment 213 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Andreas Glück, Chrysoula Zacharopoulou, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 14 e (new)

Text proposed by the Commission Amendment

(14e) European health agencies, in particular the ECDC and the EMA should be granted strengthened competences, resources and personnel to allow them to better and quicker carry out their duties efficiently to the benefit of European citizens. To anticipate any types of crises, the Commission should also evaluate the needs of the other European health agencies such as EFSA, ECHA and EU- OSHA. A stronger coordination between European Agencies should be guaranteed by the Commission.

Or. en

Amendment 214 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Andreas Glück, Chrysoula Zacharopoulou, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 14 f (new)

AM\1207705EN.docx 77/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(14f) The Programme should support the revision of ECDC’s mandate to extend its competencies to the chronical diseases, to elaborate mandatory guidances for Member States and to be able to coordinate laboratory research in times of health crises.

Or. en

Amendment 215 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Andreas Glück, Chrysoula Zacharopoulou, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 14 g (new)

Text proposed by the Commission Amendment

(14g) The programme should also support the revision of the EMA’s mandate to extend its competencies on clinical trial’s coordination and management of the shortages of medicines. EMA could therefore meet any future challenges such as monitoring and responding to shortages in coordination with the Member States. In the long term, EMA should be able to make conditional marketing authorizations upon guarantees of supply and accessibility from manufacturers. The reinforcement of the EMA’s personnel should enable the Agency to carry out inspections of production sites established in third countries.

Or. en

PE653.822v01-00 78/276 AM\1207705EN.docx EN Amendment 216 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 14 h (new)

Text proposed by the Commission Amendment

(14h) In order to facilitate EU Joint Procurement procedures, the Commission could adopt a specific legislation to promote their use to buy vaccines and treatments, to guarantee the efficiency and the transparency of the process and to ensure an equal access to medicines, medical devices, protective equipment and other relevant health products. A part of the medical products purchased via the EU joint procurement procedure could constitute a European contingency reserve of medical products subjected to shortages.

Or. en

Amendment 217 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Andreas Glück, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 14 i (new)

Text proposed by the Commission Amendment

(14i) The establishment of a communication portal for the public would allow the Union to share validated information, send alerts to European citizens and fight against disinformation. It could include a wide range of information, prevention campaigns and youth education programs. This portal could also be used to promote, in cooperation with the ECDC, a strong

AM\1207705EN.docx 79/276 PE653.822v01-00 EN immunization coverage at European level.

Or. en

Amendment 218 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 14 j (new)

Text proposed by the Commission Amendment

(14j) A digital exchange platform, such as the COVID-19 Data Portal, could facilitate exchanges on epidemiological data, science-based practice recommendations to health professionals and hospitals, and the exact state of mobilizable capacities and medical products stocks.

Or. en

Amendment 219 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 15

Text proposed by the Commission Amendment

(15) Experience from the COVID-19 (15) Experience from the COVID-19 crisis has indicated that there is a general crisis has indicated that there is a general need for the support to structural need for the support to structural transformation of and systemic reforms of transformation of and systemic reforms of health systems across the Union to improve health systems across the Union to improve their effectiveness, accessibility and their effectiveness, accessibility, resilience. In the context of such sustainability and resilience. In the context transformation and reforms, the of such transformation and reforms, the Programme should promote, in synergy Programme should promote, in synergy with the Digital Europe Programme, with the Digital Europe Programme,

PE653.822v01-00 80/276 AM\1207705EN.docx EN actions which advance digital actions which advance digital transformation of health services and transformation of health services and increase their interoperability, contribute to increase their interoperability, contribute to the increased capacity of health systems to the increased capacity of health systems to foster disease prevention and health foster (primordial, primary, secondary, promotion, to provide new care models and tertiary and quaternary) disease to deliver integrated services, from the prevention and health promotion, to community and primary health care to the provide new outcome -based care models highly specialised services, based on and to deliver integrated services, from the people's needs and ensure an efficient community and primary health care to the public health workforce equipped with the highly specialised services, based on right skills, including digital skills. The people's needs enhancing citizens’ levels development of a European health data of health literacy and digital health space would provide health care systems, literacy and ensure an efficient public researchers and public authorities with health workforce equipped with the right means to improve the availability and skills, including digital skills, regularly quality of healthcare. Given the updated in the light of scientific and fundamental right to access to preventive technological progress, as provided for by healthcare and medical treatment enshrined Directive 2005/36 on the recognition of in Article 35 of the Charter of Fundamental professional qualifications . This synergy Rights of the European Union and in view between European Health Programme to the common values and principles in and Digital Europe Programme should European Union Health Systems as set out contribute to the implementation and in the Council Conclusions of 2 June expansion of e-health, as telemedicine, 200612 the Programme should support reducing unnecessary travel and unmet actions ensuring the universality and healthcare needs. The development of a inclusivity of health care, meaning that no- European health data space and of a one is barred access to health care, and European Electronic Health Record those ensuring that patients’ rights, would provide health care systems, including on the privacy of their data, are researchers and public authorities with duly respected. means to improve the accessibility, affordability, availability and quality of healthcare, increasing the amount of data available to patients and health workers therefore 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 200612 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,

AM\1207705EN.docx 81/276 PE653.822v01-00 EN including on the privacy of their data, are duly respected. The programme needs to guarantee access to and sharing of personal health data while applying the GDPR rules meticulously and increase the digital skills of patients. ______12 Council Conclusions on Common values 12 Council Conclusions on Common values and principles in European Union Health and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1). Systems (OJ C 146, 22.6.2006, p. 1).

Or. en

Amendment 220 Mick Wallace, Clare Daly

Proposal for a regulation Recital 15

Text proposed by the Commission Amendment

(15) Experience from the COVID-19 (15) Experience from the COVID-19 crisis has indicated that there is a general crisis has indicated that there is a general need for the support to structural need for the support to structural transformation of and systemic reforms of transformation of and systemic reforms of health systems across the Union to improve health systems across the Union to improve their effectiveness, accessibility and their effectiveness, accessibility and resilience. In the context of such resilience. In the context of such transformation and reforms, the transformation and reforms, the Programme should promote, in synergy Programme should promote, in synergy with the Digital Europe Programme, with the Digital Europe Programme, actions which advance digital actions which advance digital transformation of health services and transformation of health services and increase their interoperability, contribute to increase their interoperability, contribute to the increased capacity of health systems to the increased capacity of health systems to foster disease prevention and health foster disease prevention and health promotion, to provide new care models and promotion, to provide new care models and to deliver integrated services, from the to deliver integrated services, from the community and primary health care to the community and primary health care to the highly specialised services, based on highly specialised services, based on people's needs and ensure an efficient people's needs, taking an intersectional public health workforce equipped with the and gender-sensitive approach to address right skills, including digital skills. The social determinants of health and development of a European health data differential vulnerabilities leading to space would provide health care systems, inequitable health outcomes, and ensure researchers and public authorities with an efficient public health workforce

PE653.822v01-00 82/276 AM\1207705EN.docx EN means to improve the availability and equipped with the right skills, including quality of healthcare. Given the digital skills. The development of a fundamental right to access to preventive European health data space would provide healthcare and medical treatment enshrined health care systems, researchers and public in Article 35 of the Charter of Fundamental authorities with means to improve the Rights of the European Union and in view availability and quality of healthcare. to the common values and principles in Given the fundamental right to access to European Union Health Systems as set out preventive healthcare and medical in the Council Conclusions of 2 June treatment enshrined in Article 35 of the 200612 the Programme should support Charter of Fundamental Rights of the actions ensuring the universality and European Union and in view to the inclusivity of health care, meaning that no- common values and principles in European one is barred access to health care, and Union Health Systems as set out in the those ensuring that patients’ rights, Council Conclusions of 2 June 200612 the including on the privacy of their data, are Programme should support actions duly respected. ensuring the universality and inclusivity of health care, meaning that no-one is barred access to health care, including through the achievement of Universal Health Coverage, as well as solidarity and equity, to ensure accessibility to all and equal access according to need, regardless of ethnicity, gender, age, social status or ability to pay, and to reduce health inequalities. The Programme should support actions that aim to ensure that patients’ rights are upheld, including the right to receive respectful and dignified care, free from all forms of discrimination, mistreatment or violence, the right to patient confidentiality including the privacy of their data, the right to receive accurate, unbiased information and education on all aspects of their health including sexual and reproductive health, and to give informed consent. ______12 Council Conclusions on Common values 12 Council Conclusions on Common values and principles in European Union Health and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1). Systems (OJ C 146, 22.6.2006, p. 1).

Or. en

Amendment 221 Véronique Trillet-Lenoir, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard

AM\1207705EN.docx 83/276 PE653.822v01-00 EN Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Linea Søgaard-Lidell, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 15

Text proposed by the Commission Amendment

(15) Experience from the COVID-19 (15) Experience from the COVID-19 crisis has indicated that there is a general crisis has indicated that there is a general need for the support to structural need for the support to structural transformation of and systemic reforms of transformation of and systemic reforms of health systems across the Union to improve health systems across the Union to improve their effectiveness, accessibility and their effectiveness, accessibility and resilience. In the context of such resilience. In the context of such transformation and reforms, the transformation and reforms, the Programme should promote, in synergy Programme should promote, in synergy with the Digital Europe Programme, with the Digital Europe Programme, actions which advance digital actions which advance digital transformation of health services and transformation of health services and increase their interoperability, contribute to increase their interoperability, contribute to the increased capacity of health systems to the increased capacity of health systems to foster disease prevention and health foster disease prevention and health promotion, to provide new care models and promotion, to provide new care models and to deliver integrated services, from the to deliver integrated services , from the community and primary health care to the community and primary health care to the highly specialised services, based on highly specialised services, based on people's needs and ensure an efficient people's needs and ensure an efficient public health workforce equipped with the public health workforce equipped with the right skills, including digital skills. The right skills, including digital skills. The development of a European health data programme should facilitate the collection space would provide health care systems, of large clinical and biological databases researchers and public authorities with to better understand emerging threats, means to improve the availability and rare and low prevalence diseases. Health quality of healthcare. Given the data, and how it can be securely shared in fundamental right to access to preventive full respect of General Data Protection healthcare and medical treatment enshrined Regulation (GDPR)’s requirements, will in Article 35 of the Charter of Fundamental be critically important to fight any kind of Rights of the European Union and in view health crisis and to improve the to the common values and principles in management of communicable and non- European Union Health Systems as set out communicable diseases. In this regard, in the Council Conclusions of 2 June the development of the future European 200612 the Programme should support health data space will be a crucial step to actions ensuring the universality and support patients and their health inclusivity of health care, meaning that no- providers directly, to ensure that citizens one is barred access to health care, and have control over their personal data, to those ensuring that patients’ rights, facilitate research and to support the including on the privacy of their data, are development of diagnostics, treatments and services. The European health data

PE653.822v01-00 84/276 AM\1207705EN.docx EN duly respected. 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 200612 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 more the Union relies on shared data in order to improve European healthcare, the more the EU will increase its independence over the GAFAM, its cybersecurity capabilities to guarantee data safety and to avoid security breaches that would expose personal information of patients. ______12 Council Conclusions on Common values 12 Council Conclusions on Common values and principles in European Union Health and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1). Systems (OJ C 146, 22.6.2006, p. 1).

Or. en

Amendment 222 Cristian-Silviu Buşoi

Proposal for a regulation Recital 15

Text proposed by the Commission Amendment

(15) Experience from the COVID-19 (15) Experience from the COVID-19 crisis has indicated that there is a general crisis has indicated that there is a general need for the support to structural need for the support to structural transformation of and systemic reforms of transformation of and systemic reforms of health systems across the Union to improve health systems across the Union to improve their effectiveness, accessibility and their effectiveness, accessibility and

AM\1207705EN.docx 85/276 PE653.822v01-00 EN resilience. In the context of such resilience. In the context of such transformation and reforms, the transformation and reforms, the Programme should promote, in synergy Programme should promote, in synergy with the Digital Europe Programme, with the Digital Europe Programme, actions which advance digital actions which advance digital transformation of health services and transformation of health services and increase their interoperability, contribute to increase their interoperability, contribute to the increased capacity of health systems to the increased capacity of health systems to foster disease prevention and health foster disease prevention and health promotion, to provide new care models and promotion, to provide new care models and to deliver integrated services, from the to deliver integrated services, from the community and primary health care to the community and primary health care to the highly specialised services, based on highly specialised services, based on people's needs and ensure an efficient people's needs, enhancing citizens’ levels public health workforce equipped with the of health literacy and digital health right skills, including digital skills. The literacy and ensure an efficient public development of a European health data health workforce equipped with the right space would provide health care systems, skills, including digital skills. The researchers and public authorities with development of a European health data means to improve the availability and space and of a European Electronic quality of healthcare. Given the Health Record would provide health care fundamental right to access to preventive systems, researchers and public authorities healthcare and medical treatment enshrined with means to improve the accessibility, in Article 35 of the Charter of Fundamental availability, affordability and quality of Rights of the European Union and in view healthcare. The Programme must ensure, to the common values and principles in in setting up the European Health Data European Union Health Systems as set out Space, adequate resources for ECDC/ in the Council Conclusions of 2 June national agencies to collect data on 200612 the Programme should support diagnosis, care and outcomes. It must also actions ensuring the universality and provide resources and integrate data inclusivity of health care, meaning that no- collected by civil society. Given the one is barred access to health care, and fundamental right to access to preventive those ensuring that patients’ rights, healthcare and medical treatment enshrined including on the privacy of their data, are in Article 35 of the Charter of Fundamental duly respected. 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 200612 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, clear and easy to understand and exercise by patients and adapted to innovation and new technologies.

PE653.822v01-00 86/276 AM\1207705EN.docx EN ______12 Council Conclusions on Common values 12 Council Conclusions on Common values and principles in European Union Health and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1). Systems (OJ C 146, 22.6.2006, p. 1).

Or. en

Amendment 223 Sirpa Pietikäinen

Proposal for a regulation Recital 15

Text proposed by the Commission Amendment

(15) Experience from the COVID-19 (15) Experience from the COVID-19 crisis has indicated that there is a general crisis has indicated that there is a general need for the support to structural need for the support to structural transformation of and systemic reforms of transformation of and systemic reforms of health systems across the Union to improve health systems across the Union to improve their effectiveness, accessibility and their effectiveness, accessibility and resilience. In the context of such resilience. In the context of such transformation and reforms, the transformation and reforms, the Programme should promote, in synergy Programme should promote, in synergy with the Digital Europe Programme, with the Digital Europe Programme, actions which advance digital actions which advance digital transformation of health services and transformation of health services and increase their interoperability, contribute to increase their interoperability, contribute to the increased capacity of health systems to the increased capacity of health systems to foster disease prevention and health foster disease prevention and health promotion, to provide new care models and promotion, to provide new care models and to deliver integrated services, from the to deliver integrated services, from the community and primary health care to the community and primary health care to the highly specialised services, based on highly specialised services, based on people's needs and ensure an efficient people's needs and ensure an efficient public health workforce equipped with the public health workforce equipped with the right skills, including digital skills. The right skills, including digital skills. The development of a European health data development of a European health data space would provide health care systems, space and of a European Electronic researchers and public authorities with Health Record would provide health care means to improve the availability and systems, researchers and public authorities quality of healthcare. Given the with means to improve the availability and fundamental right to access to preventive quality of healthcare. Such European healthcare and medical treatment Health Record should be standardised, enshrined in Article 35 of the Charter of interoperable with different health data Fundamental Rights of the European Union systems and accessible for the patients in

AM\1207705EN.docx 87/276 PE653.822v01-00 EN and in view to the common values and all Member States with privacy ensured principles in European Union Health and information encoded into the Systems as set out in the Council European Health Insurance Card, EHIC. Conclusions of 2 June 200612 the Given the fundamental right to access to Programme should support actions preventive health care and medical ensuring the universality and inclusivity of treatment enshrined in Article 35 of the health care, meaning that no-one is barred Charter of Fundamental Rights of the access to health care, and those ensuring European Union and in view to the that patients’ rights, including on the common values and principles in European privacy of their data, are duly respected. Union Health Systems as set out in the Council Conclusions of 2 June 200612 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. ______12 Council Conclusions on Common values 12 Council Conclusions on Common values and principles in European Union Health and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1). Systems (OJ C 146, 22.6.2006, p. 1).

Or. en

Justification

We need a European Electronic Health Record, with standardised information, accessible in identified form only to emergency units. Personalised data should be owned and accessible only by the person involved by a passcode comparable to bankcard pin codes. This pin code could be added to the European Health Insurance Card (EHIC) where the patients’ health care records ‘could be waived over by the patients with the pin code.

Amendment 224 Kateřina Konečná

Proposal for a regulation Recital 15

Text proposed by the Commission Amendment

(15) Experience from the COVID-19 (15) Experience from the COVID-19 crisis has indicated that there is a general crisis has indicated that there is a general need for the support to structural need for the support to structural transformation of and systemic reforms of transformation of and systemic reforms of health systems across the Union to improve health systems across the Union to improve their effectiveness, accessibility and their effectiveness, accessibility and

PE653.822v01-00 88/276 AM\1207705EN.docx EN resilience. In the context of such resilience. In the context of such transformation and reforms, the transformation and reforms, the Programme should promote, in synergy Programme should promote, in synergy with the Digital Europe Programme, with the Digital Europe Programme, actions which advance digital actions which advance digital transformation of health services and transformation of health services and increase their interoperability, contribute to increase their interoperability, contribute to the increased capacity of health systems to the increased capacity of health systems to foster disease prevention and health foster disease prevention and health promotion, to provide new care models and promotion, to provide new care models and to deliver integrated services, from the to deliver integrated services, from the community and primary health care to the community and primary health care to the highly specialised services, based on highly specialised services, based on people's needs and ensure an efficient people's needs, enhancing citizens’ levels public health workforce equipped with the of health literacy and digital health right skills, including digital skills. The literacy and ensure an efficient public development of a European health data health workforce equipped with the right space would provide health care systems, skills, including digital skills. The researchers and public authorities with development of a European health data means to improve the availability and space and of a European Electronic quality of healthcare. Given the Health Record would provide health care fundamental right to access to preventive systems, researchers and public authorities healthcare and medical treatment enshrined with means to improve the availability and in Article 35 of the Charter of Fundamental quality of healthcare. Given the Rights of the European Union and in view fundamental right to access to preventive to the common values and principles in healthcare and medical treatment enshrined European Union Health Systems as set out in Article 35 of the Charter of Fundamental in the Council Conclusions of 2 June Rights of the European Union and in view 200612 the Programme should support to the common values and principles in actions ensuring the universality and European Union Health Systems as set out inclusivity of health care, meaning that no- in the Council Conclusions of 2 June one is barred access to health care, and 200612 the Programme should support those ensuring that patients’ rights, actions ensuring the universality and including on the privacy of their data, are inclusivity of health care, meaning that no- duly respected. one is barred access to health care, and those ensuring that patients’ rights, including on the privacy of their data, are duly respected, clear and easy to understand and exercise by patients and adapted to innovation and new technologies. ______12 Council Conclusions on Common values 12 Council Conclusions on Common values and principles in European Union Health and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1). Systems (OJ C 146, 22.6.2006, p. 1).

Or. en

AM\1207705EN.docx 89/276 PE653.822v01-00 EN Justification

Patients’ rights on data protection need to be fully ensured, clearly understandable by patients and adapted to the rapid evolution of technology in healthcare. EU legislation, on top of ensuring adequate protection and safety, should be designed to ensure that the exercise of rights is simple and not overly burdensome.

Amendment 225 Mairead McGuinness

Proposal for a regulation Recital 15

Text proposed by the Commission Amendment

(15) Experience from the COVID-19 (15) Experience from the COVID-19 crisis has indicated that there is a general crisis has indicated that there is a general need for the support to structural need for the support to structural transformation of and systemic reforms of transformation of and systemic reforms of health systems across the Union to improve health systems across the Union to improve their effectiveness, accessibility and their effectiveness, accessibility and resilience. In the context of such resilience. In the context of such transformation and reforms, the transformation and reforms, the Programme should promote, in synergy Programme should promote, in synergy with the Digital Europe Programme, with the Digital Europe Programme, actions which advance digital actions which advance digital transformation of health services and transformation of health services and increase their interoperability, contribute to increase their interoperability, contribute to the increased capacity of health systems to the increased capacity of health systems to foster disease prevention and health foster disease prevention and health promotion, to provide new care models and promotion, to provide new care models, to to deliver integrated services, from the progress deinstitutionalisation and move community and primary health care to the towards community-based care including highly specialised services, based on for older people, and to deliver integrated people's needs and ensure an efficient services, from the community and primary public health workforce equipped with the health care to the highly specialised right skills, including digital skills. The services, based on people's needs and development of a European health data ensure an efficient public health workforce space would provide health care systems, equipped with the right skills, including researchers and public authorities with digital skills. The development of a means to improve the availability and European health data space would provide quality of healthcare. Given the health care systems, researchers and public fundamental right to access to preventive authorities with means to improve the healthcare and medical treatment enshrined availability and quality of healthcare. in Article 35 of the Charter of Fundamental Given the fundamental right to access to Rights of the European Union and in view preventive healthcare and medical to the common values and principles in treatment enshrined in Article 35 of the

PE653.822v01-00 90/276 AM\1207705EN.docx EN European Union Health Systems as set out Charter of Fundamental Rights of the in the Council Conclusions of 2 June European Union and in view to the 200612 the Programme should support common values and principles in European actions ensuring the universality and Union Health Systems as set out in the inclusivity of health care, meaning that no- Council Conclusions of 2 June 200612 the one is barred access to health care, and Programme should support actions those ensuring that patients’ rights, ensuring the universality and inclusivity of including on the privacy of their data, are health care, meaning that no-one is barred duly respected. access to health care, and those ensuring that patients’ rights, including on the privacy of their data, are duly respected. ______12 Council Conclusions on Common values 12 Council Conclusions on Common values and principles in European Union Health and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1). Systems (OJ C 146, 22.6.2006, p. 1).

Or. en

Amendment 226 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 15

Text proposed by the Commission Amendment

(15) Experience from the COVID-19 (15) Experience from the COVID-19 crisis has indicated that there is a general crisis has indicated that there is a general need for the support to structural need for the support to structural transformation of and systemic reforms of transformation of and systemic reforms of health systems across the Union to improve health systems across the Union to improve their effectiveness, accessibility and their effectiveness, accessibility and resilience. In the context of such resilience. In the context of such transformation and reforms, the transformation and reforms, the Programme should promote, in synergy Programme should promote, in synergy with the Digital Europe Programme, with the Digital Europe Programme, actions which advance digital actions which advance digital transformation of health services and transformation of health services and increase their interoperability, contribute to increase their interoperability, contribute to the increased capacity of health systems to the increased capacity of health systems to foster disease prevention and health foster disease prevention and health promotion, to provide new care models and promotion, to provide new care models and to deliver integrated services, from the to deliver integrated services, from the community and primary health care to the community and primary health care to the highly specialised services, based on highly specialised services, based on people's needs and ensure an efficient people's needs and ensure an efficient

AM\1207705EN.docx 91/276 PE653.822v01-00 EN public health workforce equipped with the public health workforce equipped with the right skills, including digital skills. The right skills, including digital skills. The development of a European health data development of a European health data space would provide health care systems, space and of a European Electronic researchers and public authorities with Health Record would provide health care means to improve the availability and systems, researchers and public authorities quality of healthcare. Given the with means to improve the accessibility, fundamental right to access to preventive availability, affordability availability and healthcare and medical treatment enshrined quality of healthcare. Given the in Article 35 of the Charter of Fundamental fundamental right to access to preventive Rights of the European Union and in view healthcare and medical treatment enshrined to the common values and principles in in Article 35 of the Charter of Fundamental European Union Health Systems as set out Rights of the European Union and in view in the Council Conclusions of 2 June to the common values and principles in 200612 the Programme should support European Union Health Systems as set out actions ensuring the universality and in the Council Conclusions of 2 June inclusivity of health care, meaning that no- 200612 the Programme should support one is barred access to health care, and actions ensuring the universality and those ensuring that patients’ rights, inclusivity of health care, meaning that no- including on the privacy of their data, are one is barred access to health care, and duly respected. those ensuring that patients’ rights, including on the privacy of their data, are duly respected. ______12 Council Conclusions on Common values 12 Council Conclusions on Common values and principles in European Union Health and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1). Systems (OJ C 146, 22.6.2006, p. 1).

Or. en

Amendment 227 Cristian-Silviu Buşoi

Proposal for a regulation Recital 15 a (new)

Text proposed by the Commission Amendment

(15a) The COVID-19 situation has taught us the importance of health as a public good which needs to be preserved by developing coherent approaches to tackle chronic conditions, be they communicable or non-communicable, and by exploiting synergies in approaching people at risk. The COVID-

PE653.822v01-00 92/276 AM\1207705EN.docx EN 19 situation has also highlighted the imperative to generate and share reliable data on diagnosis, treatment and cure via the ECDC across the EU. It has also confirmed the need to apply innovative solutions to identify people at risk of having an infectious disease, so they can be tested, linked to care and take precautions to prevent further transmissions, leading to disease elimination. Notwithstanding the differences in transmission routes, these learnings also apply to viral hepatitis, where the ECDC report from May 2020 which monitors progress towards the elimination of hepatitis B and C in the EU/EEA highlights that “hepatitis related mortality is high in the region and there is very little evidence of progress towards the 2030 elimination target of a 65% reduction in mortality against the 2015 baseline". The ECDC report thus confirms that, unless the EU drives forward the prevention of transmission, diagnosis and linkage to care, Europe will fail to meet the WHO elimination target and will fail to deliver on its commitment to the UN SDG.

Or. en

Amendment 228 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 15 a (new)

Text proposed by the Commission Amendment

(15a) The value of health data is essential for having more reliable information to improve healthcare services, health policy-making and to evaluate the implementation of actions and policies in our society. The European

AM\1207705EN.docx 93/276 PE653.822v01-00 EN Health Data Space will represent a strong pillar of health in the Union and should be constructed involving all sectors and stakeholders, taking into account the needs of health professionals and patient. The Programme should capacitate and enlarge the competence of the ECDC to improve the capacity of surveillance of NCDs. The European Health Data should collect data on healthcare use, health behaviour and health problems, including information on rare diseases, vaccination, allergies and others.

Or. en

Amendment 229 Adam Jarubas

Proposal for a regulation Recital 15 a (new)

Text proposed by the Commission Amendment

(15a) Effective use of Information Technology systems, including AI, in full respect of EU data protection and privacy legal framework, is key to improve regulatory efficiency across Europe; it is also necessary to optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and interdependency of the European regulatory framework, and to ensure a fit for purpose regulatory environment that is a key element to protect public health, provide access to high quality medicines and contribute to the prevention of shortages.

Or. en

Amendment 230 Sirpa Pietikäinen

PE653.822v01-00 94/276 AM\1207705EN.docx EN Proposal for a regulation Recital 15 a (new)

Text proposed by the Commission Amendment

(15a) A regulation on patient's rights is needed to ensure the right to accessible, affordable and high quality patient- centred health care, including relevant, appropriate and value based medicinal care, right to affordable, effective medication, rehabilitation and support for care. The right to cross-border health care and adequate support services should be guaranteed. Patients' right to second opinions should also be ensured.

Or. en

Amendment 231 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Linea Søgaard-Lidell, Chrysoula Zacharopoulou, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 15 a (new)

Text proposed by the Commission Amendment

(15a) The programme should support innovations in the digitalization area that could bring concrete benefits to patients and healthcare professionals and provide cost-effective high-quality healthcare whilst reducing inequalities. Important steps could be taken in digital skills, both for healthcare professionals and patients training, especially in rural and sparsely populated areas.

Or. en

AM\1207705EN.docx 95/276 PE653.822v01-00 EN Amendment 232 Cristian-Silviu Buşoi

Proposal for a regulation Recital 15 b (new)

Text proposed by the Commission Amendment

(15b) Generating and sharing reliable data on health systems’ management of communicable diseases is essential to track the progress made and tailor national and local systems’ responses across Europe in a coordinated manner. The Programme should therefore support the upscaling of the ECDC’s competence and resources in monitoring health care systems’ responses to transmittable diseases, including HIV, TB and viral hepatitis. In particular, additional resources should be channelled to support the creation of EU-wide databases, with the aim to provide an overview of the existing gaps in the continuum of care. EU-wide data sharing should also help monitor the management of such conditions in the long-term and from a holistic perspective, including the management of relevant comorbidities and the overall progress of the system in improving the health-related quality of life of patients.

Or. en

Amendment 233 Sirpa Pietikäinen

Proposal for a regulation Recital 15 b (new)

Text proposed by the Commission Amendment

(15b) It is important to guarantee equal access for patients in different Member States to effective therapeutics, treatments and prevent individual health care units

PE653.822v01-00 96/276 AM\1207705EN.docx EN from excessive and unreasonable costs when treating rare diseases. The Commission should therefore explore the possibility to establish a European fund, co-financed by the Member States, for negotiating and purchasing the orphan medicines and other new, personalised and experimental medication.

Or. en

Amendment 234 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Linea Søgaard-Lidell, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 15 b (new)

Text proposed by the Commission Amendment

(15b) The programme should facilitate the reinforcement of e-health and m- health as well as the use of telemedicine and remote monitoring of patients, especially in times of sanitary crises.

Or. en

Amendment 235 Cristian-Silviu Buşoi

Proposal for a regulation Recital 15 c (new)

Text proposed by the Commission Amendment

(15c) Ensuring a fit for purpose regulatory environment is a key element to protect public health, provide access to high quality medicines and contribute to the prevention of shortages. The effective use of Information Technology systems will improve regulatory efficiency across Europe; it is important therefore to

AM\1207705EN.docx 97/276 PE653.822v01-00 EN optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and interdependency of the European regulatory framework.

Or. en

Amendment 236 Traian Băsescu

Proposal for a regulation Recital 16

Text proposed by the Commission Amendment

(16) Keeping people healthy and active (16) Keeping people healthy and active longer and empowering them to take an longer and empowering them to take an active role in managing their health will active role in managing their health will have positive effects on health, health have positive effects on health, health inequalities, quality of life, productivity, inequalities, quality of life, productivity, competitiveness and inclusiveness, while competitiveness and inclusiveness, while reducing pressures on national budgets. reducing pressures on national budgets. The Commission has committed to help Furthermore, to ensure optimal efficiency Member States to reach the sustainable of the programme, state paternalism must development targets set in the ‘UN 2030 be accompanied by the conceptualisation Agenda for Sustainable Development’ in of health as a mutual responsibility of particular Sustainable Development Goal 3 both the citizens and state authorities, as ‘Ensure healthy lives and promote well- health is a partnership that both imposes being for all at all ages’13. The Programme obligations and confers rights. In therefore should contribute to the actions developing health education, the taken towards reaching these goals. programme will have even greater success if it can enhance citizens’ ability to play an active role in managing their own personal health. It is crucial to strengthen medical autonomy in order to better manage self-care. All of the parties concerned have equal responsibility, including the general public, patients, medical professionals, trainers, administrators, researchers, governments, including legislative and regulatory bodies, professional associations, and certification bodies. The Commission has committed to help Member States to reach the sustainable development targets set in

PE653.822v01-00 98/276 AM\1207705EN.docx EN 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. ______13 Communication from the Commission to 13 Communication from the Commission to the European Parliament, the Council, the the European Parliament, the Council, the European Economic and Social Committee European Economic and Social Committee and the Committee of the Regions Next and the Committee of the Regions Next steps for a sustainable European future. steps for a sustainable European future. European action for sustainability COM European action for sustainability COM (2016) 739 final of 22.11.2016. (2016) 739 final of 22.11.2016.

Or. ro

Amendment 237 Joanna Kopcińska

Proposal for a regulation Recital 16

Text proposed by the Commission Amendment

(16) Keeping people healthy and active (16) Keeping people healthy and active longer and empowering them to take an longer and empowering them to take an active role in managing their health will active role in managing their health will have positive effects on health, health have positive effects on health, health inequalities, quality of life, productivity, inequalities, quality of life, productivity, competitiveness and inclusiveness, while competitiveness and inclusiveness, while reducing pressures on national budgets. reducing pressures on national budgets. The Commission has committed to help Recognition of innovation, which has a Member States to reach the sustainable profound impact on health outcomes and development targets set in the 'UN 2030 costs, also serves to address the challenges Agenda for Sustainable Development’ in of achieving sustainability in the health particular Sustainable Development Goal 3 sector and the impact of changing "Ensure healthy lives and promote well- demographics. Moreover, action to reduce being for all at all ages".13 The Programme inequalities in the provision of healthcare therefore should contribute to the actions in rural and remote areas is important for taken towards reaching these goals. 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

AM\1207705EN.docx 99/276 PE653.822v01-00 EN 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. ______13 Communication from the Commission to 13 Communication from the Commission to the European Parliament, the Council, the the European Parliament, the Council, the European Economic and Social Committee European Economic and Social Committee and the Committee of the Regions Next and the Committee of the Regions Next steps for a sustainable European future. steps for a sustainable European future. European action for sustainability COM European action for sustainability COM (2016) 739 final of 22.11.2016. (2016) 739 final of 22.11.2016.

Or. en

Amendment 238 Sara Cerdas, Tudor Ciuhodaru, Rovana Plumb, Milan Brglez, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 16

Text proposed by the Commission Amendment

(16) Keeping people healthy and active (16) Health is an investment and the longer and empowering them to take an Programme should have this concept at active role in managing their health will its core. Keeping people healthy and active have positive effects on health, health longer and empowering them to take an inequalities, quality of life, productivity, active role in managing their health competitiveness and inclusiveness, while through health literacy in order to take reducing pressures on national budgets. well informed decisions, will have positive The Commission has committed to help effects on health, health inequalities, Member States to reach the sustainable health iniquities, quality of life, development targets set in the 'UN 2030 productivity, competitiveness and Agenda for Sustainable Development’ in inclusiveness, while reducing pressures on particular Sustainable Development Goal 3 national health systems and budgets. The "Ensure healthy lives and promote well- Commission has committed to help being for all at all ages"13. The Programme Member States to reach the sustainable therefore should contribute to the actions development targets set in the 'UN 2030 taken towards reaching these goals. 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

PE653.822v01-00 100/276 AM\1207705EN.docx EN taken towards reaching the SDGs goals, consequently will improve the social determinants of health and enhance the health of the Union. ______13 Communication from the Commission to 13 Communication from the Commission to the European Parliament, the Council, the the European Parliament, the Council, the European Economic and Social Committee European Economic and Social Committee and the Committee of the Regions Next and the Committee of the Regions Next steps for a sustainable European future. steps for a sustainable European future. European action for sustainability COM European action for sustainability COM (2016) 739 final of 22.11.2016. (2016) 739 final of 22.11.2016.

Or. en

Amendment 239 Cristian-Silviu Buşoi

Proposal for a regulation Recital 16

Text proposed by the Commission Amendment

(16) Keeping people healthy and active (16) Keeping people healthy and active longer and empowering them to take an longer and empowering them to take an active role in managing their health will active role in managing their health, by have positive effects on health, health improving their health literacy, will have inequalities, quality of life, productivity, positive effects on health, health competitiveness and inclusiveness, while inequalities, quality of life, productivity, reducing pressures on national budgets. competitiveness and inclusiveness, while The Commission has committed to help reducing pressures on national budgets. Member States to reach the sustainable The Commission has committed to help development targets set in the 'UN 2030 Member States to reach the sustainable Agenda for Sustainable Development’ in development targets set in the 'UN 2030 particular Sustainable Development Goal 3 Agenda for Sustainable Development’ in "Ensure healthy lives and promote well- particular Sustainable Development Goal 3 being for all at all ages".13 The Programme "Ensure healthy lives and promote well- therefore should contribute to the actions being for all at all ages".13 The Programme taken towards reaching these goals. therefore should contribute to the actions taken towards reaching these goals, for e.g. by recognizing the strategic role of health literacy in managing personal health. ______13 Communication from the Commission to 13 Communication from the Commission to the European Parliament, the Council, the the European Parliament, the Council, the

AM\1207705EN.docx 101/276 PE653.822v01-00 EN European Economic and Social Committee European Economic and Social Committee and the Committee of the Regions Next and the Committee of the Regions Next steps for a sustainable European future. steps for a sustainable European future. European action for sustainability COM European action for sustainability COM (2016) 739 final of 22.11.2016. (2016) 739 final of 22.11.2016.

Or. en

Amendment 240 Antoni Comín i Oliveres

Proposal for a regulation Recital 16 a (new)

Text proposed by the Commission Amendment

(16a) We now know that social and economic determinants are a persistent source of inequalities in health. One of the priority objectives of Member States' public health systems should be the fight against these inequalities. The COVID- 19pandemic has threatened the European population as a whole, but once again the most economically vulnerable populations have been the most affected. It is essential that the projects of the EU4Health programme are managed in accordance with the general and transversal objective of reducing health inequalities. Likewise, the EU4Health programme's projects should also serve to assist Member States in the reformulation of the budgets of their health systems, with the aim of making them more clearly redistributed according to the criteria of health inequalities of the population.

Or. en

Amendment 241 Luisa Regimenti, Joëlle Mélin, Catherine Griset, Simona Baldassarre, Danilo Oscar Lancini, Lucia Vuolo, Silvia Sardone, Vincenzo Sofo, Marco Dreosto, Aurelia Beigneux

PE653.822v01-00 102/276 AM\1207705EN.docx EN Proposal for a regulation Recital 16 a (new)

Text proposed by the Commission Amendment

(16a) The Programme should provide for equal access to healthcare. ‘Socioeconomic health inequalities’ cover situations ranging from unequal access to treatment, fragmented access across regions and differences in health status based on economic conditions, to the distribution of health determinants between different population groups. The individual Member States are responsible for developing social and health polices to tackle the national challenges linked to health inequalities.

Or. it

Amendment 242 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Recital 16 a (new)

Text proposed by the Commission Amendment

(16a) The Programme should provide for equal and fair access to healthcare. “Health inequalities” cover situations ranging from unequal access to treatment, fragmented access across regions, differences in health status origin, and to the distribution of health determinants between different population groups. Health inequalities and inequities are avoidable by reasonable means, and thus preventable, and the Programme should improve the knowledge on health inequalities and inequities to tackle them.

Or. en

AM\1207705EN.docx 103/276 PE653.822v01-00 EN Amendment 243 Michèle Rivasi

Proposal for a regulation Recital 16 a (new)

Text proposed by the Commission Amendment

(16a) The Programme should provide for equal access to healthcare. “Health inequalities” cover situations ranging from unequal access to prevention, treatment, fragmented access across regions, differences in health status origin, and to the distribution of health determinants between different population groups. Health inequalities are avoidable by reasonable means, and thus preventable.

Or. en

Justification

Like AM 13 of the rapporteur, with the addition of a reference to "prevention".

Amendment 244 Sirpa Pietikäinen

Proposal for a regulation Recital 16 a (new)

Text proposed by the Commission Amendment

(16a) Gender and sex sensitivity and knowledge needs to be improved in the education of health care professionals, the research, diagnosis, treatment and impact of medicines and therapeutics to better understand and treat both sexes.

Or. en

PE653.822v01-00 104/276 AM\1207705EN.docx EN Amendment 245 Sirpa Pietikäinen

Proposal for a regulation Recital 16 b (new)

Text proposed by the Commission Amendment

(16b) Training for health care professionals and specialised health care facilities needs to be provided so that the needs of groups such as LGBTIQ, Roma and other groups with special needs can be met.

Or. en

Amendment 246 Sirpa Pietikäinen

Proposal for a regulation Recital 16 c (new)

Text proposed by the Commission Amendment

(16c) The programme should provide easy access to basic healthcare to all. Low-threshold guidance, counselling, and access to preventive health care should be available to all citizens. Family doctor system for necessary health checks to provide preventive healthcare should be promoted. Adequacy of this capacity should be monitored in the European Semester.

Or. en

Amendment 247 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 17

AM\1207705EN.docx 105/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(17) Non-communicable diseases are a (17) Non-communicable diseases are a result of a combination of genetic, result of commercial determinants of physiological, environmental and health a combination of genetic, behavioural factors. Such non- physiological, environmental and communicable diseases as cardiovascular behavioural factors. Such non- diseases, cancer, chronic respiratory communicable diseases as cardiovascular diseases, and diabetes, represent major diseases, cancer, chronic respiratory causes of disability, ill-health, health- diseases, diabetes and mental health related retirement, and premature death in illness represent major causes of disability, the Union, resulting in considerable social ill-health, health-related retirement, and and economic impacts. To decrease the premature death in the Union, with non- impact of non-communicable diseases on communicable diseases (NCDs) were individuals and society in the Union and responsible for 87% of Disability-Adjusted reach goal 3 of the Sustainable Life Years (DALYs) in the EU in 2017, Development Goals, Target 3.4, to reduce resulting in considerable social and premature mortality from non- economic impacts. To decrease the impact communicable diseases by one third by of non-communicable diseases on 2030, it is key to provide an integrated individuals and society in the Union and response focusing on prevention across reach goal 3 of the Sustainable sectors and policy fields, combined with Development Goals, particularly but not efforts to strengthen health systems. 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 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 societies.

Or. en

Amendment 248 Michèle Rivasi

Proposal for a regulation Recital 17

Text proposed by the Commission Amendment

(17) Non-communicable diseases are a (17) Non-communicable diseases are a result of a combination of genetic, result of a combination of genetic, physiological, environmental and physiological, environmental and

PE653.822v01-00 106/276 AM\1207705EN.docx EN behavioural factors. Such non- behavioural risk factors. Such non- communicable diseases as cardiovascular communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, cancer, chronic respiratory diseases, and diabetes, represent major diseases, and diabetes, represent major causes of disability, ill-health, health- causes of disability, ill-health, health- related retirement, and premature death in related retirement, and premature death in the Union, resulting in considerable social the Union, resulting in considerable social and economic impacts. To decrease the and economic impacts. To decrease the impact of non-communicable diseases on impact of non-communicable diseases on individuals and society in the Union and individuals and society in the Union and reach goal 3 of the Sustainable reach goal 3 of the Sustainable Development Goals, Target 3.4, to reduce Development Goals, Target 3.4, to reduce premature mortality from non- premature mortality from non- communicable diseases by one third by communicable diseases by one third by 2030, it is key to provide an integrated 2030, it is key to provide an integrated response focusing on prevention across response focusing on prevention across sectors and policy fields, combined with sectors and policy fields, combined with efforts to strengthen health systems. efforts to strengthen health systems. SDG Target 3.a, 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.

Or. en

Amendment 249 Joanna Kopcińska

Proposal for a regulation Recital 17

Text proposed by the Commission Amendment

(17) Non-communicable diseases are a (17) Non-communicable diseases are a result of a combination of genetic, result of a combination of genetic, physiological, environmental and physiological, environmental and behavioural factors. Such non- behavioural factors. Such non- communicable diseases as cardiovascular communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, cancer, chronic respiratory diseases, and diabetes, represent major diseases, and diabetes, represent major causes of disability, ill-health, health- causes of disability, ill-health, health- related retirement, and premature death in related retirement, and premature death in the Union, resulting in considerable social the Union, resulting in considerable social and economic impacts. To decrease the and economic impacts. To decrease the impact of non-communicable diseases on impact of non-communicable diseases on

AM\1207705EN.docx 107/276 PE653.822v01-00 EN individuals and society in the Union and individuals and society in the Union and reach goal 3 of the Sustainable reach goal 3 of the Sustainable Development Goals, Target 3.4, to reduce Development Goals, Target 3.4, to reduce premature mortality from non- premature mortality from non- communicable diseases by one third by communicable diseases by one third by 2030, it is key to provide an integrated 2030, it is key to have sufficient financial response focusing on prevention across resources, follow a "Health in all sectors and policy fields, combined with Policies" (HIAP) approach, provide an efforts to strengthen health systems. integrated response focusing on health promotion and primary prevention across sectors and policy fields, combined with efforts to strengthen health systems that will have a direct impact on the long-term public health policy of all Member States.

Or. en

Amendment 250 Nicolae Ştefănuță

Proposal for a regulation Recital 17

Text proposed by the Commission Amendment

(17) Non-communicable diseases are a (17) Non-communicable diseases are a result of a combination of genetic, result of a combination of genetic, physiological, environmental and physiological, environmental and behavioural factors. Such non- behavioural factors and commercial communicable diseases as cardiovascular determinant of health. Such non- diseases, cancer, chronic respiratory communicable diseases as cardiovascular diseases, and diabetes, represent major diseases, cancer, chronic respiratory causes of disability, ill-health, health- diseases, and diabetes, represent major related retirement, and premature death in causes of disability, ill-health, health- the Union, resulting in considerable social related retirement, and premature death in and economic impacts. To decrease the the Union, resulting in considerable social impact of non-communicable diseases on and economic impacts. To decrease the individuals and society in the Union and impact of non-communicable diseases on reach goal 3 of the Sustainable individuals and society in the Union and Development Goals, Target 3.4, to reduce reach goal 3 of the Sustainable premature mortality from non- Development Goals, Target 3.4, to reduce communicable diseases by one third by premature mortality from non- 2030, it is key to provide an integrated communicable diseases by one third by response focusing on prevention across 2030, it is key to provide an integrated sectors and policy fields, combined with response focusing on prevention across efforts to strengthen health systems. sectors and policy fields, promotion of a healthy lifestyle combined with efforts to

PE653.822v01-00 108/276 AM\1207705EN.docx EN strengthen health systems.

Or. en

Amendment 251 Nathalie Colin-Oesterlé

Proposal for a regulation Recital 17

Text proposed by the Commission Amendment

(17) Non-communicable diseases are a (17) Non-communicable diseases are a result of a combination of genetic, result of a combination of genetic, physiological, environmental and physiological, environmental and behavioural factors. Such non- behavioural factors. Such non- communicable diseases as cardiovascular communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, cancer, chronic respiratory diseases, and diabetes represent major diseases, rare diseases and diabetes causes of disability, ill-health, health- represent major causes of disability, ill- related retirement, and premature death in health, health-related retirement, and the Union, resulting in considerable social premature death in the Union, resulting in and economic impacts. To decrease the considerable social and economic impacts. impact of non-communicable diseases on To decrease the impact of non- individuals and society in the Union and communicable diseases on individuals and reach goal 3 of the Sustainable society in the Union and reach goal 3 of the Development Goals, Target 3.4, to reduce Sustainable Development Goals, Target premature mortality from non- 3.4, to reduce premature mortality from communicable diseases by one third by non-communicable diseases by one third 2030, it is key to provide an integrated by 2030, it is key to provide an integrated response focusing on prevention across response focusing on prevention across sectors and policy fields, combined with sectors and policy fields, combined with efforts to strengthen health systems. efforts to strengthen health systems and the supply of appropriate medicines.

Or. fr

Amendment 252 Linea Søgaard-Lidell, Frédérique Ries, Jan Huitema

Proposal for a regulation Recital 17

AM\1207705EN.docx 109/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(17) Non-communicable diseases are a (17) Non-communicable diseases are a result of a combination of genetic, result of a combination of genetic, physiological, environmental and physiological, environmental and behavioural factors. Such non- behavioural factors. Such non- communicable diseases as cardiovascular communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, cancer, obesity, chronic diseases, and diabetes, represent major respiratory diseases, diabetes and causes of disability, ill-health, health- neurologic disorder represent major causes related retirement, and premature death in of disability, ill-health, health-related the Union, resulting in considerable social retirement, and premature death in the and economic impacts. To decrease the Union, resulting in considerable social and impact of non-communicable diseases on economic impacts. To decrease the impact individuals and society in the Union and of non-communicable diseases on reach goal 3 of the Sustainable individuals and society in the Union and Development Goals, Target 3.4, to reduce reach goal 3 of the Sustainable premature mortality from non- Development Goals, Target 3.4, to reduce communicable diseases by one third by premature mortality from non- 2030, it is key to provide an integrated communicable diseases by one third by response focusing on prevention across 2030, it is key to provide an integrated sectors and policy fields, combined with response focusing on prevention across efforts to strengthen health systems. sectors and policy fields, combined with efforts to strengthen health systems.

Or. en

Amendment 253 Bartosz Arłukowicz, Jarosław Duda

Proposal for a regulation Recital 17

Text proposed by the Commission Amendment

(17) Non-communicable diseases are a (17) Non-communicable diseases are a result of a combination of genetic, result of a combination of genetic, physiological, environmental and physiological, environmental and behavioural factors. Such non- behavioural factors. Such non- communicable diseases as cardiovascular communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, cancer, neurological disorders, diseases, and diabetes, represent major chronic respiratory diseases, and diabetes, causes of disability, ill-health, health- represent major causes of disability, ill- related retirement, and premature death in health, health-related retirement, and the Union, resulting in considerable social premature death in the Union, resulting in and economic impacts. To decrease the considerable social and economic impacts.

PE653.822v01-00 110/276 AM\1207705EN.docx EN impact of non-communicable diseases on To decrease the impact of non- individuals and society in the Union and communicable diseases on individuals and reach goal 3 of the Sustainable society in the Union and reach goal 3 of the Development Goals, Target 3.4, to reduce Sustainable Development Goals, Target premature mortality from non- 3.4, to reduce premature mortality from communicable diseases by one third by non-communicable diseases by one third 2030, it is key to provide an integrated by 2030, it is key to provide an integrated response focusing on prevention across response focusing on prevention across sectors and policy fields, combined with sectors and policy fields, combined with efforts to strengthen health systems. efforts to strengthen health systems.

Or. pl

Amendment 254 Mairead McGuinness

Proposal for a regulation Recital 17

Text proposed by the Commission Amendment

(17) Non-communicable diseases are a (17) Non-communicable diseases are a result of a combination of genetic, result of a combination of genetic, physiological, environmental and physiological, environmental and behavioural factors. Such non- behavioural factors. Such non- communicable diseases as cardiovascular communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, cancer, chronic respiratory diseases, and diabetes, represent major diseases, diabetes and mental health causes of disability, ill-health, health- conditions, represent major causes of related retirement, and premature death in disability, ill-health, health-related the Union, resulting in considerable social retirement, and premature death in the and economic impacts. To decrease the Union, resulting in considerable social and impact of non-communicable diseases on economic impacts. To decrease the impact individuals and society in the Union and of non-communicable diseases on reach goal 3 of the Sustainable individuals and society in the Union and Development Goals, Target 3.4, to reduce reach goal 3 of the Sustainable premature mortality from non- Development Goals, Target 3.4, to reduce communicable diseases by one third by premature mortality from non- 2030, it is key to provide an integrated communicable diseases by one third by response focusing on prevention across 2030, it is key to provide an integrated sectors and policy fields, combined with response focusing on prevention across efforts to strengthen health systems. sectors and policy fields, combined with efforts to strengthen health systems.

Or. en

AM\1207705EN.docx 111/276 PE653.822v01-00 EN Amendment 255 Luisa Regimenti, Joëlle Mélin, Catherine Griset, Simona Baldassarre, Danilo Oscar Lancini, Lucia Vuolo, Silvia Sardone, Vincenzo Sofo, Marco Dreosto, Aurelia Beigneux

Proposal for a regulation Recital 17

Text proposed by the Commission Amendment

(17) Non-communicable diseases are a (17) Non-communicable diseases are a result of a combination of genetic, result of a combination of genetic, physiological, environmental and physiological, environmental and behavioural factors. Such non- behavioural factors. Such non- communicable diseases as cardiovascular communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, cancer, neurological disorders, diseases, and diabetes, represent major chronic respiratory diseases, and diabetes, causes of disability, ill-health, health- represent major causes of disability, ill- related retirement, and premature death in health, health-related retirement, and the Union, resulting in considerable social premature death in the Union, resulting in and economic impacts. To decrease the considerable social and economic impacts. impact of non-communicable diseases on To decrease the impact of non- individuals and society in the Union and communicable diseases on individuals and reach goal 3 of the Sustainable society in the Union and reach goal 3 of the Development Goals, Target 3.4, to reduce Sustainable Development Goals, Target premature mortality from non- 3.4, to reduce premature mortality from communicable diseases by one third by non-communicable diseases by one third 2030, it is key to provide an integrated by 2030, it is key to provide an integrated response focusing on prevention across response focusing on prevention across sectors and policy fields, combined with sectors and policy fields, combined with efforts to strengthen health systems. efforts to strengthen health systems.

Or. it

Amendment 256 Kateřina Konečná

Proposal for a regulation Recital 17

Text proposed by the Commission Amendment

(17) Non-communicable diseases are a (17) Non-communicable diseases are a result of a combination of genetic, result of a combination of genetic, physiological, environmental and physiological, environmental and behavioural factors. Such non- behavioural factors. Such non- communicable diseases as cardiovascular communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, cancer, neurological disorders,

PE653.822v01-00 112/276 AM\1207705EN.docx EN diseases, and diabetes, represent major chronic respiratory diseases, and diabetes, causes of disability, ill-health, health- represent major causes of disability, ill- related retirement, and premature death in health, health-related retirement, and the Union, resulting in considerable social premature death in the Union, resulting in and economic impacts. To decrease the considerable social and economic impacts. impact of non-communicable diseases on To decrease the impact of non- individuals and society in the Union and communicable diseases on individuals and reach goal 3 of the Sustainable society in the Union and reach goal 3 of the Development Goals, Target 3.4, to reduce Sustainable Development Goals, Target premature mortality from non- 3.4, to reduce premature mortality from communicable diseases by one third by non-communicable diseases by one third 2030, it is key to provide an integrated by 2030, it is key to provide an integrated response focusing on prevention across response focusing on prevention across sectors and policy fields, combined with sectors and policy fields, combined with efforts to strengthen health systems. efforts to strengthen health systems.

Or. en

Justification

Due to their exceptional disease burden and increased global prioritisation, neurological disorders should become one of the priorities in the EU4Health Programme.

Amendment 257 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 17

Text proposed by the Commission Amendment

(17) Non-communicable diseases are a (17) Non-communicable diseases are a result of a combination of genetic, result of a combination of genetic, physiological, environmental and physiological, environmental and behavioural factors. Such non- behavioural factors. Such non- communicable diseases as cardiovascular communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, cancer, chronic respiratory diseases, and diabetes, represent major diseases, and diabetes, represent major causes of disability, ill-health, health- causes of disability, ill-health, health- related retirement, and premature death in related retirement, and premature death in the Union, resulting in considerable social the Union, resulting in considerable and economic impacts. To decrease the affective, social and economic impacts. To impact of non-communicable diseases on decrease the impact of non-communicable individuals and society in the Union and diseases on individuals and society in the reach goal 3 of the Sustainable Union and reach goal 3 of the Sustainable

AM\1207705EN.docx 113/276 PE653.822v01-00 EN Development Goals, Target 3.4, to reduce Development Goals, Target 3.4, to reduce premature mortality from non- premature mortality from non- communicable diseases by one third by communicable diseases by one third by 2030, it is key to provide an integrated 2030, it is key to provide an integrated response focusing on prevention across response focusing on prevention across sectors and policy fields, combined with sectors and policy fields, combined with efforts to strengthen health systems. efforts to strengthen health systems.

Or. en

Amendment 258 Mick Wallace

Proposal for a regulation Recital 17 a (new)

Text proposed by the Commission Amendment

(17a) Chronic diseases develop slowly, are long-lasting and often incurable. Chronic disease patients often live with several comorbidities, which makes it complex to treat and manage them. The Union and the Member States can greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines, such as cardiovascular disease, neurodegenerative diseases, respiratory diseases and diabetes. Moreover, a significant proportion of chronic diseases are preventable by addressing major risk factors such as tobacco use, unhealthy diets, physical inactivity and air quality. Chronic diseases develop slowly, are long-lasting and often incurable. Chronic disease patients often live with several comorbidities, which makes it complex to treat and manage them. The Union and the Member States can greatly reduce the burden of Member States by working together to achieve a better and more

PE653.822v01-00 114/276 AM\1207705EN.docx EN effective management of diseases, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines, such as cardiovascular disease, neurodegenerative diseases, respiratory diseases and diabetes. Moreover, a significant proportion of chronic diseases are preventable by addressing major risk factors such as tobacco use, unhealthy diets, physical inactivity and air quality.

Or. en

Justification

To stem the burden from chronic diseases, it is essential to invest both in primary population- based prevention and control and management of patients.

Amendment 259 Michèle Rivasi

Proposal for a regulation Recital 17 a (new)

Text proposed by the Commission Amendment

(17a) Prevention and health promotion are key in achieving sustainable health systems by ensuring that citizens live disease-free longer and by reducing the pressure of preventable diseases, especially of non-communicable diseases, on health systems. In order to enhance the health status and quality of life of Union citizens, primary care healthcare professionals, including community pharmacists, and community groups should be involved in raising public health awareness, participating in disease prevention and control. The Programme should support Union actions and support Member States in developing and implementing prevention and health promotion, early diagnosis and screening strategies. This includes healthy public

AM\1207705EN.docx 115/276 PE653.822v01-00 EN policies, community action for health, supportive environments and reorienting disease prevention services as part of primary health care services towards health promotion. Screening programmes need to be evidence-based and avoid adverse effects and unnecessary burden on health services.

Or. en

Justification

The strategies of WHO Ottawa Charter on Health Promotion – healthy public policies, supportive environments, community action for health and healthy lifestyles, and reorienting health services – should be a framework for public health. Health care needs to be reoriented towards a more integrative holistic model, which includes health education and promotion.

Amendment 260 Linea Søgaard-Lidell, Jan Huitema

Proposal for a regulation Recital 17 a (new)

Text proposed by the Commission Amendment

(17a) Chronic diseases develop slowly, are long-lasting and often incurable. Chronic disease patients often live with several comorbidities, which makes it complex to treat and manage them. The Union and the Member States can greatly reduce the burden on Member States by working together to achieve a better and more effective management of diseases, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines, for diseases such as cardiovascular disease, neurodegenerative diseases, respiratory diseases, obesity and diabetes. In making these guidelines, special attention should be given to major risk factors such as tobacco use, alcohol consumption, unhealthy diet, physical inactivity and air quality.

PE653.822v01-00 116/276 AM\1207705EN.docx EN Or. en

Amendment 261 Margarita de la Pisa Carrión

Proposal for a regulation Recital 17 a (new)

Text proposed by the Commission Amendment

(17a) Communicable diseases such as HIV/AIDS, tuberculosis and viral hepatitis have a social dimension that needs to be addressed in a multidisciplinary manner. They should be tackled not only with antivirals and vaccines, but also with education, information, and appropriate social and psychological measures. This approach is well understood for problems such as drug or alcohol addiction. To this end, it is essential to invest in innovative community-based approaches to communicable disease control and prevention strategies for sexually transmitted infections.

Or. es

Amendment 262 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 17 a (new)

Text proposed by the Commission Amendment

(17a) The role of primary prevention and health promotion is key to address long term, common European challenges such as non-communicable and communicable diseases, ageing and cross- border health threats such as future pandemics, antimicrobial resistance. The Union can bring additional added-value

AM\1207705EN.docx 117/276 PE653.822v01-00 EN to offer an overall public health strategy based on identified best practices and the European dimension of identified health challenges in the area of access to healthcare, health prevention and promotion in order to reduce health inequalities and health differences in Europe.

Or. en

Amendment 263 César Luena

Proposal for a regulation Recital 17 a (new)

Text proposed by the Commission Amendment

(17a) Early detection and screening of non-communicable diseases, such as heart diseases, plays a crucial role in all treatment and prevention strategies. The Programme should support Union actions and support Member States in developing and implementing prevention, early diagnosis and screening strategies. Joint Actions and similar initiatives with the goal of improving early detection, especially of non-communicable diseases such as Structural Heart Disease, are strongly encouraged.

Or. en

Amendment 264 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 17 a (new)

PE653.822v01-00 118/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(17a) Mental and psychological well- being is crucial for good mental health. The Programme should be aimed at improving the mental health of individuals and society, including the promotion of mental well-being, the prevention of mental disorders, the protection of human rights and the care of people affected by mental disorders and neurological diseases.

Or. en

Amendment 265 Cristian-Silviu Buşoi

Proposal for a regulation Recital 17 a (new)

Text proposed by the Commission Amendment

(17a) In the implementation of those prevention, vaccination, early diagnosis and screening strategies, it is imperative that the Programme exploit synergies with the ESF+ and other programmes.

Or. en

Amendment 266 Michèle Rivasi

Proposal for a regulation Recital 17 b (new)

Text proposed by the Commission Amendment

(17b) Early detection and screening plays a crucial role in all treatment and prevention strategies. Prevention is key in achieving sustainable health systems by ensuring that citizens live disease-free

AM\1207705EN.docx 119/276 PE653.822v01-00 EN longer and by reducing the pressure of preventable diseases, especially of non- communicable diseases, on health systems. In order to enhance the health status and quality of life of Union citizens, primary care healthcare professionals, including community pharmacists, should be involved in raising public health awareness, participating in disease prevention and control. The Programme should support Union actions and support Member States in developing and implementing prevention, early diagnosis and screening strategies. This includes disease prevention services as part of primary healthcare services and the implementation of population level policies to address social, environmental and behavioural risk factors.

Or. en

Justification

Like amendment 16 of the rapporteur with the addition of population level policies.

Amendment 267 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Recital 17 b (new)

Text proposed by the Commission Amendment

(17b) Early detection and screening plays a crucial role in prevention strategies and in timely treatment and health outcomes. Prevention is key in achieving sustainable health systems by ensuring that citizens live disease-free longer and by reducing the pressure of preventable diseases, especially of non- communicable diseases, on health systems. In order to enhance the health status, well-being, and quality of life of

PE653.822v01-00 120/276 AM\1207705EN.docx EN Union citizens, primary care healthcare professionals, including community pharmacists, local authorities and citizens should be involved in raising public health awareness, participating in disease prevention and control. The Programme should support Union actions and support Member States in developing and implementing prevention, early diagnosis and screening strategies. This includes disease prevention services as part of primary healthcare services.

Or. en

Amendment 268 Cristian-Silviu Buşoi

Proposal for a regulation Recital 17 b (new)

Text proposed by the Commission Amendment

(17b) The role of primary prevention and health promotion is key to address long term, common European challenges such as non-communicable and communicable diseases, ageing and cross- border health threats such as future pandemics or health crises, and antimicrobial resistance. The Union can bring additional added-value to offer an overall public health strategy based on identified best practices and the European dimension of identified health challenges in the area of access to healthcare, health prevention and promotion in order to reduce health inequalities and health differences in Europe.

Or. en

Amendment 269 Margarita de la Pisa Carrión

AM\1207705EN.docx 121/276 PE653.822v01-00 EN Proposal for a regulation Recital 17 b (new)

Text proposed by the Commission Amendment

(17b) Sexually transmitted diseases represent a growing health burden, with added risks of cancer and multi- resistance.

Or. es

Amendment 270 Michèle Rivasi

Proposal for a regulation Recital 17 c (new)

Text proposed by the Commission Amendment

(17c) To achieve Universal Health Coverage as highlighted in the Political Declaration on UHC adopted by the United Nations in September 2019, the EU and its Member States will strive to achieve all targets of SDG 3. In addition to SDG 3.4, it will be essential to achieve SDG3.7 on sexual and reproductive health and rights, as this is a crucial component of UHC. This Programme should therefore contribute to the universal access to and full respect of sexual and reproductive health and rights at the Union and international level.

Or. en

Amendment 271 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 18

PE653.822v01-00 122/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention have a holistic approach to individual throughout the lifetime of an individual health and the link with all the health and to health promotion by addressing determinants: socio-economic, health risk factors, such as the use of environmental, health system, commercial tobacco and related products and exposure and individual determinants of health. To to their emissions, the harmful use of achieve the best health status possible, the alcohol, and the consumption of illicit Programme should tackle all the drugs. The Programme should also determinants. Health promotion, health contribute to the reduction of drugs-related protection and disease prevention health damage, unhealthy dietary habits throughout the lifetime of an individual and physical inactivity, and exposure to should be at the core of the programme by environmental pollution, and foster addressing health and mental risk factors, supportive environments for healthy such as the use of tobacco and related lifestyles in order to complement Member products and exposure to their emissions, States action in these areas. The the harmful use of alcohol, and the Programme should also therefore consumption of harmful drugs and other contribute to the objectives of the addictive behaviours. The Programme European Green Deal, the Farm to Fork should also contribute to the reduction of Strategy and the Biodiversity Strategy. drugs-related health damage, unhealthy dietary habits, lack of physical activity that can lead to a person becoming overweight and suffering from obesity, 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 promotion and protection, throughout the entire lifetime of an individual, including through the promotion of physical activity, nutritional care and promotion of health education and health literacy. The Programme should also strengthen and support Health in All Policies and support the implementation of health assessment of EU policies. The Programme should also contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy and these policies should take into account the Programme objectives.

Or. en

AM\1207705EN.docx 123/276 PE653.822v01-00 EN Amendment 272 Biljana Borzan

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing commercial factors, such as the use of tobacco and determinants of health, such as the use of related products and exposure to their tobacco and related products and exposure emissions, the harmful use of alcohol, and to their emissions, alcohol use, the the consumption of illicit drugs. The unhealthy food environment and the Programme should also contribute to the consumption of illicit drugs and reduction of drugs-related health damage, psychoactive substances. The Programme unhealthy dietary habits and physical should also contribute to the reduction of inactivity, and exposure to environmental drugs-related health damage, obesity and pollution, and foster supportive unhealthy dietary habits, physical environments for healthy lifestyles in order inactivity, and exposure to environmental to complement Member States action in pollution, and foster health supportive these areas. The Programme should also environments in order to complement therefore contribute to the objectives of the Member States action in these areas. The European Green Deal, the Farm to Fork Programme therefore should contribute to Strategy and the Biodiversity Strategy. 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 EU health related legislation, including in the area of environmental health, and foster Health in All Policies. The Programme should also contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.

Or. en

Amendment 273 Cristian-Silviu Buşoi

PE653.822v01-00 124/276 AM\1207705EN.docx EN Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing determinants of factors, such as the use of tobacco and health, such as the use of tobacco and related products and exposure to their related products and exposure to their emissions, the harmful use of alcohol, and emissions, the harmful use of alcohol, and the consumption of illicit drugs. The the consumption of drugs and psychoactive Programme should also contribute to the substances. The Programme should also reduction of drugs-related health damage, contribute to the reduction of drugs-related unhealthy dietary habits and physical health damage, obesity and unhealthy inactivity, and exposure to environmental dietary habits and physical inactivity, and pollution, and foster supportive exposure to environmental pollution, and environments for healthy lifestyles in order foster health supportive environments for to complement Member States action in healthy lifestyles in order to complement these areas. The Programme should also Member States action in these areas. The therefore contribute to the objectives of the Programme therefore should contribute to European Green Deal, the Farm to Fork a high level of human health protection Strategy and the Biodiversity Strategy. 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 EU health related legislation, including in the area of environmental health, and foster Health in All Policies. The Programme should also contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.

Or. en

Amendment 274 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should

AM\1207705EN.docx 125/276 PE653.822v01-00 EN contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing health risk factors, such as the use of tobacco and factors, such as the use of tobacco and related products and exposure to their related products and exposure to their emissions, the harmful use of alcohol, and emissions, the harmful use of alcohol, and the consumption of illicit drugs. The the consumption of illicit drugs. The Programme should also contribute to the Programme should contribute to the reduction of drugs-related health damage, reduction of drugs-related health damage, unhealthy dietary habits and physical unhealthy dietary habits and physical inactivity, and exposure to environmental inactivity. The Programme should also pollution, and foster supportive address environmental risk factors, environments for healthy lifestyles in order minimising exposure to air pollution, to to complement Member States action in water or land contamination, to physical, these areas. The Programme should also chemical or biological hazards, and therefore contribute to the objectives of the reduce the impact of climate change European Green Deal, the Farm to Fork disruptions on human and animal health. Strategy and the Biodiversity Strategy. The Programme should 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.

Or. en

Amendment 275 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing health risk factors, such as the use of tobacco and factors, such as the use of tobacco and related products and exposure to their related products and exposure to their emissions, the harmful use of alcohol, and emissions, the alcohol abuse and the the consumption of illicit drugs. The consumption of illicit drugs. The Programme should also contribute to the Programme should also contribute to the reduction of drugs-related health damage, reduction of drugs-related health damage,

PE653.822v01-00 126/276 AM\1207705EN.docx EN unhealthy dietary habits and physical unhealthy dietary habits via the adoption inactivity, and exposure to environmental of a mandatory harmonized nutrition pollution, and foster supportive label such as the Nutri-Score and physical environments for healthy lifestyles in order inactivity, and exposure to environmental to complement Member States action in pollution, and foster supportive these areas. The Programme should also environments for healthy lifestyles in order therefore contribute to the objectives of the to complement Member States action in European Green Deal, the Farm to Fork these areas. The Programme should also Strategy and the Biodiversity Strategy. therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy, the Biodiversity Strategy and Chemicals Strategy for Sustainability.

Or. en

Amendment 276 Frédérique Ries, Linea Søgaard-Lidell

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing health risk factors, such as the use of tobacco and factors, such as the use of tobacco and related products and exposure to their related products and exposure to their emissions, the harmful use of alcohol, and emissions, the harmful use of alcohol, and the consumption of illicit drugs. The the consumption of illicit drugs. The Programme should also contribute to the Programme should also contribute to the reduction of drugs-related health damage, reduction of drugs-related health damage, unhealthy dietary habits and physical unhealthy dietary habits, physical inactivity inactivity, and exposure to environmental and obesity, and exposure to pollution, and foster supportive environmental and indoor pollution, and environments for healthy lifestyles in order foster supportive environments for healthy to complement Member States action in lifestyles in order to complement Member these areas. The Programme should also States action in these areas. The therefore contribute to the objectives of the Programme should also therefore European Green Deal, the Farm to Fork contribute to the objectives of the Strategy and the Biodiversity Strategy. European Green Deal, the Farm to Fork Strategy, the Biodiversity Strategy and the Chemicals strategy for sustainability.

Or. en

AM\1207705EN.docx 127/276 PE653.822v01-00 EN Amendment 277 Linea Søgaard-Lidell, Jan Huitema

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing health risk factors, such as the use of tobacco and factors, such as the use of tobacco and related products and exposure to their related products and exposure to their emissions, the harmful use of alcohol, and emissions, the harmful use of alcohol, and the consumption of illicit drugs. The the consumption of illicit drugs. The Programme should also contribute to the Programme should also contribute to the reduction of drugs-related health damage, reduction of drugs-related health damage, unhealthy dietary habits and physical obesity, unhealthy dietary habits and inactivity, and exposure to environmental physical inactivity, and exposure to pollution, and foster supportive environmental pollution, and foster environments for healthy lifestyles in order supportive environments for healthy to complement Member States action in lifestyles in order to complement Member these areas. The Programme should also States action in these areas. The therefore contribute to the objectives of the Programme should also therefore European Green Deal, the Farm to Fork contribute to the objectives of the Strategy and the Biodiversity Strategy. European Green Deal, the Farm to Fork Strategy, the Biodiversity Strategy and Chemicals Strategy for Sustainability.

Or. en

Amendment 278 Joanna Kopcińska

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing health risk factors, such as the use of tobacco and factors, such as the use of tobacco and

PE653.822v01-00 128/276 AM\1207705EN.docx EN related products and exposure to their related products and exposure to their emissions, the harmful use of alcohol, and emissions, the harmful use of alcohol and the consumption of illicit drugs. The the consumption of illicit drugs. The Programme should also contribute to the Programme should also contribute to the reduction of drugs-related health damage, reduction of drugs-related health damage, unhealthy dietary habits and physical unbalanced diets and obesity, physical inactivity, and exposure to environmental inactivity, mental health and exposure to pollution, and foster supportive environmental pollution, and foster environments for healthy lifestyles in order supportive environments for healthy to complement Member States action in lifestyles in order to complement Member these areas. The Programme should also States action in these areas. The therefore contribute to the objectives of the Programme should also therefore European Green Deal, the Farm to Fork contribute to the objectives of the Strategy and the Biodiversity Strategy. European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.

Or. en

Amendment 279 Michèle Rivasi

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing health risk factors, such as the use of tobacco and factors, such as the use of tobacco and related products and exposure to their related products and exposure to their emissions, the harmful use of alcohol, and emissions, the harmful use of alcohol, and the consumption of illicit drugs. The the consumption of illicit drugs. The Programme should also contribute to the Programme should also contribute to the reduction of drugs-related health damage, reduction of drugs-related health damage, unhealthy dietary habits and physical unhealthy dietary habits and physical inactivity, and exposure to environmental inactivity, and exposure to environmental pollution, and foster supportive pollution in light of the zero-pollution environments for healthy lifestyles in order ambition for a toxic-free environment, to complement Member States action in and foster supportive environments for these areas. The Programme should also healthy lifestyles in order to complement therefore contribute to the objectives of the Member States action in these areas. The European Green Deal, the Farm to Fork Programme should also therefore Strategy and the Biodiversity Strategy. contribute to the objectives of the European Green Deal, the Farm to Fork

AM\1207705EN.docx 129/276 PE653.822v01-00 EN Strategy and the Biodiversity Strategy.

Or. en

Amendment 280 Jytte Guteland

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing health risk factors, such as the use of tobacco and factors, such as the use of tobacco and related products and exposure to their related products and exposure to their emissions, the harmful use of alcohol, and emissions, the harmful use of alcohol, and the consumption of illicit drugs. The the consumption of illicit drugs. The Programme should also contribute to the Programme should also contribute to the reduction of drugs-related health damage, reduction of drugs-related health damage, unhealthy dietary habits and physical unhealthy dietary habits and physical inactivity, and exposure to environmental inactivity, and exposure to environmental pollution, and foster supportive pollution, and foster supportive environments for healthy lifestyles in order environments for healthy lifestyles in order to complement Member States action in to complement Member States action in these areas. The Programme should also these areas. Since zoonoses regularly therefore contribute to the objectives of the emerge as a result of frequent and closer European Green Deal, the Farm to Fork interactions between animals, humans, Strategy and the Biodiversity Strategy. and ecosystems, due to loss of habitat for agricultural purposes - especially for the intensification of animal farming - and wildlife exploitation, the Programme should also contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.

Or. en

Amendment 281 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 18

PE653.822v01-00 130/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(18) The Programme therefore should (18) Health promotion and health contribute to disease prevention throughout prevention are vastly more cost-efficient the lifetime of an individual and to health than treatment, both in terms of money promotion by addressing health risk and of quality-adjusted life years, factors, such as the use of tobacco and therefore the program should contribute to related products and exposure to their disease prevention throughout the lifetime emissions, the harmful use of alcohol, and of an individual and to health promotion by the consumption of illicit drugs. The addressing health risk factors, such as the Programme should also contribute to the use of tobacco and related products and reduction of drugs-related health damage, exposure to their emissions, the harmful unhealthy dietary habits and physical use of alcohol, and the consumption of inactivity, and exposure to environmental illicit drugs. The Programme should also pollution, and foster supportive contribute to the reduction of drugs-related environments for healthy lifestyles in order health damage, unhealthy dietary habits to complement Member States action in and physical inactivity, and exposure to these areas. The Programme should also environmental pollution, and foster therefore contribute to the objectives of the supportive environments for healthy European Green Deal, the Farm to Fork lifestyles in order to complement Member Strategy and the Biodiversity Strategy. 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.

Or. en

Amendment 282 Rob Rooken

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing health risk factors, such as the use of tobacco and factors, such as the use of tobacco and related products and exposure to their related products and exposure to their emissions, the harmful use of alcohol, and emissions, the harmful use of alcohol, and the consumption of illicit drugs. The the consumption of illicit drugs. The Programme should also contribute to the Programme should also contribute to the reduction of drugs-related health damage, reduction of drugs-related health damage,

AM\1207705EN.docx 131/276 PE653.822v01-00 EN unhealthy dietary habits and physical unhealthy dietary habits and physical inactivity, and exposure to environmental inactivity, and exposure to environmental pollution, and foster supportive pollution, and foster supportive environments for healthy lifestyles in order environments for healthy lifestyles in order to complement Member States action in to complement Member States action in these areas. The Programme should also these areas. therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.

Or. nl

Amendment 283 Margarita de la Pisa Carrión

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing health risk factors, such as the use of tobacco and factors, such as the use of tobacco and related products and exposure to their related products and exposure to their emissions, the harmful use of alcohol, and emissions, the harmful use of alcohol, and the consumption of illicit drugs. The the consumption of illicit drugs. The Programme should also contribute to the Programme should also contribute to the reduction of drugs-related health damage, reduction of drugs-related health damage, unhealthy dietary habits and physical unhealthy dietary habits and physical inactivity, and exposure to environmental inactivity, and exposure to environmental pollution, and foster supportive pollution, and foster supportive environments for healthy lifestyles in order environments for healthy lifestyles in order to complement Member States action in to complement Member States action in these areas. The Programme should also these areas. therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.

Or. es

PE653.822v01-00 132/276 AM\1207705EN.docx EN Amendment 284 Mairead McGuinness

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing health risk factors, such as the use of tobacco and factors, such as the use of tobacco and related products and exposure to their related products and exposure to their emissions, the harmful use of alcohol, and emissions, the harmful use of alcohol, and the consumption of illicit drugs. The the consumption of illicit drugs. The Programme should also contribute to the Programme should also contribute to the reduction of drugs-related health damage, reduction of drugs-related health damage, unhealthy dietary habits and physical obesity, unhealthy dietary habits and inactivity, and exposure to environmental physical inactivity, and exposure to pollution, and foster supportive environmental pollution, and foster environments for healthy lifestyles in order supportive environments for healthy to complement Member States action in lifestyles in order to complement Member these areas. The Programme should also States action in these areas. The therefore contribute to the objectives of the Programme should also therefore European Green Deal, the Farm to Fork contribute to the objectives of the Strategy and the Biodiversity Strategy. European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.

Or. en

Amendment 285 Mick Wallace

Proposal for a regulation Recital 18

Text proposed by the Commission Amendment

(18) The Programme therefore should (18) The Programme therefore should contribute to disease prevention throughout contribute to disease prevention throughout the lifetime of an individual and to health the lifetime of an individual and to health promotion by addressing health risk promotion by addressing risk factors, such factors, such as the use of tobacco and as the use of tobacco and related products related products and exposure to their and exposure to their emissions, the emissions, the harmful use of alcohol, and harmful use of alcohol, and the the consumption of illicit drugs. The consumption of illicit drugs. The

AM\1207705EN.docx 133/276 PE653.822v01-00 EN Programme should also contribute to the Programme should also contribute to the reduction of drugs-related health damage, reduction of drugs-related health damage, unhealthy dietary habits and physical unhealthy dietary habits and physical inactivity, and exposure to environmental inactivity, and exposure to environmental pollution, and foster supportive pollution, and foster supportive environments for healthy lifestyles in order environments for healthy lifestyles in order to complement Member States action in to complement Member States action in these areas. The Programme should also these areas. The Programme should also therefore contribute to the objectives of the therefore contribute to the objectives of the European Green Deal, the Farm to Fork European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy. Strategy and the Biodiversity Strategy.

Or. en

Amendment 286 Michèle Rivasi

Proposal for a regulation Recital 18 a (new)

Text proposed by the Commission Amendment

(18a) The burden of chronic diseases is still significant in the Union. Chronic diseases develop slowly, are long-lasting and often incurable. Chronic diseases are, in many cases, associated with more than one comorbidity, which makes them even more difficult to treat and manage. They have caused great human suffering and placed an enormous burden on health systems, as well. However, many chronic diseases, such as cardiovascular diseases and type 2 diabetes, could be prevented by healthy lifestyle choices through well- evidenced measures to address risk factors, 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 prevention and management of diseases, and the Programme should support actions in this area. The

PE653.822v01-00 134/276 AM\1207705EN.docx EN Programme should support the development of specific European Diseases Prevention and Management Guidelines in the area of both communicable and non-communicable diseases, such as cardiovascular diseases, neurodegenerative diseases, respiratory diseases and diabetes. The Programme should also support actions at national and local level to support the implementation of the WHO “Best Buys for tackling NCDs 1a”. ______1a https://apps.who.int/iris/handle/10665/259 232

Or. en

Justification

Like amendment 18 of the rapporteur, but referring to addressing risk factors rather than healthy lifestyle choices, adding "prevention" into the guidelines and adding the reference to the WHO's recommendation on non-communicable diseases.

Amendment 287 Cristian-Silviu Buşoi

Proposal for a regulation Recital 18 a (new)

Text proposed by the Commission Amendment

(18a) A holistic long-term health care approach is necessary in view of the growing prevalence of chronic diseases among an ageing EU population. As many conditions that were once fatal, such as HIV, increasingly become chronic and manageable conditions thanks to innovative treatments, healthcare systems need to adapt and provide a comprehensive model of care that takes into account the specific needs of people affected by chronic diseases, thereby improving their health-related

AM\1207705EN.docx 135/276 PE653.822v01-00 EN quality of life. The Programme should support the development of integrated systems of care that allow for multidisciplinary, cross-disease cooperation between health practitioners in order to ensure that people living with chronic diseases receive adequate support, including in the management of co- morbidities and other health-related issues, such as mental health conditions.

Or. en

Amendment 288 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 18 a (new)

Text proposed by the Commission Amendment

(18a) Given that health needs differ during a person's lifetime, the Programme should also support Member States to create and implement health programmes that are aligned with the needs of population, and should work to achieve a minimum standard in health programmes that tackle specific populations, such as children's health, maternal health and ageing-related health, as programmes that are horizontal to the lifetime as mental health and reproductive and sexual health.

Or. en

Amendment 289 Nathalie Colin-Oesterlé

Proposal for a regulation Recital 18 a (new)

PE653.822v01-00 136/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(18a) Today, there is a lack of awareness about chronic diseases, such as migraines, despite their psychological and socioeconomic impact; it is important to ensure that neurological disorders, including migraines, are given proper consideration in European policies. The EU and the Member States should include migraines and other chronic diseases in their health priorities.

Or. fr

Amendment 290 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

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 EU alcohol strategy. Protecting children from alcohol commercial communication as well as product placement and sponsorship of alcohol brands, especially in the online environment, should be one of the Programme’s priorities.

Or. en

Amendment 291 Inese Vaidere

Proposal for a regulation Recital 18 a (new)

AM\1207705EN.docx 137/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(18a) The Programme should aim to reduce health inequalities including unequal access to treatment and medicines across Member States;

Or. en

Amendment 292 Cristian-Silviu Buşoi

Proposal for a regulation Recital 18 b (new)

Text proposed by the Commission Amendment

(18b) The burden of chronic diseases is still significant in the Union. Chronic diseases develop slowly, are long-lasting and often incurable. Chronic diseases are, in many cases, associated with more than one comorbidity, which makes them even more difficult to treat and manage. They have caused great human suffering and placed an enormous burden on health systems, as well. However, many chronic diseases, such as cardiovascular diseases, cancer and type 2 diabetes, could be prevented through access to prevention services, affordability of healthy nutrition and healthy lifestyle, while other illnesses, for instance neurological diseases, can be managed to slow from the onset, if detected early, or helping patients feel their best and remain active for longer. The Union and the Member States can therefore greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, including prevention and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines in the

PE653.822v01-00 138/276 AM\1207705EN.docx EN area of both communicable and non- communicable diseases, such as cardiovascular diseases, neurodegenerative diseases, cancer, respiratory diseases and diabetes.

Or. en

Amendment 293 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Christel Schaldemose

Proposal for a regulation Recital 18 b (new)

Text proposed by the Commission Amendment

(18b) The burden of chronic diseases is still significant in the Union. Chronic diseases develop slowly, are long-lasting and often incurable. Chronic diseases are, in many cases, associated with more than one comorbidity, which makes them even more difficult to treat and manage. They have caused great human suffering and placed an enormous burden on health systems, as well. However, many chronic diseases, such as cardiovascular diseases, cancer and type 2 diabetes, could be prevented through access to prevention services, affordability of healthy nutrition and healthy lifestyle, while other illnesses, for instance neurological diseases, can be managed to slow their onset if detected early, or helping patients feel their best and remain active for longer. The Union and Member States can therefore greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, including prevention, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines in the area of both communicable and non-

AM\1207705EN.docx 139/276 PE653.822v01-00 EN communicable diseases, such as cardiovascular diseases, neurodegenerative diseases, cancer, respiratory diseases and diabetes.

Or. en

Amendment 294 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Linea Søgaard-Lidell, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 18 b (new)

Text proposed by the Commission Amendment

(18b) Vaccination prevents an estimated 2,5 million deaths each year worldwide and reduces disease-specific treatment costs. The introduction of large-scale protective vaccinations in Europe has significantly contributed to the eradication or decline of many infectious diseases. Nevertheless, the worrying phenomenon of vaccine hesitancy and the disinformation on vaccination should be addressed by the Programme to reassure European citizens.

Or. en

Amendment 295 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Recital 18 c (new)

Text proposed by the Commission Amendment

(18c) The International Agency for Research on Cancer (IARC) considered classified diesel engine exhaust as

PE653.822v01-00 140/276 AM\1207705EN.docx EN carcinogenic to humans. The Programme should make sure that the health impacts and costs of air pollution are integrated into the Union action against cancer, while ensuring full coherence with the European zero emission strategy.

Or. en

Amendment 296 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Linea Søgaard-Lidell, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 19

Text proposed by the Commission Amendment

(19) Cancer is the second leading cause (19) Cancer is the second leading cause of mortality in the Member States after of mortality in the Member States after cardiovascular diseases. It is also one of cardiovascular diseases. Cancer is caused non-communicable diseases that share by many factors in multiple stages and common risk factors and the prevention therefore requires a new prevention and control of which would benefit the paradigm that addresses individual health majority of citizens. In 2020 the determinants (genetic, lifestyle) and wider Commission announced the ‘Europe’s (populations) determinants related to Beating Cancer Plan’ which would cover occupational, environmental and social the entire cycle of the disease starting exposure factors; It is also one of non- from prevention and early diagnosis to communicable diseases that share common treatment and quality of life of patients risk factors with others and the prevention and survivors. The measures should and control of which would benefit the benefit from the Programme and from majority of citizens. Poor nutrition, Horizon Europe’s Mission on Cancer. physical inactivity, obesity, tobacco and alcohol are risk factors common to other chronic diseases, such as cardiovascular diseases, type 2 diabetes, and respiratory diseases, and therefore cancer prevention programmes should be conducted within the context of an integrated chronic disease prevention programme. In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover every key stage of the disease :prevention, diagnosis, treatment, life as a cancer survivor, reinsertion and palliative care. The programme should promote actions

AM\1207705EN.docx 141/276 PE653.822v01-00 EN to improve cancer patients' rights including the return to work with a disability, the right to be forgotten, the access to preserved fertility and provide optimal relief during the end-of-life stage. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer which will work in close link.

Or. en

Amendment 297 Michèle Rivasi

Proposal for a regulation Recital 19

Text proposed by the Commission Amendment

(19) Cancer is the second leading cause (19) Cardiovascular disease is the of mortality in the Member States after leading cause of mortality in the Member cardiovascular diseases. It is also one of States (36% of all deaths in the EU), non-communicable diseases that share followed by cancer as the second leading common risk factors and the prevention cause of mortality in the Member States and control of which would benefit the (26% of all deaths in the EU). They are majority of citizens. In 2020 the also amongst the non-communicable Commission announced the ‘Europe’s diseases that share common risk factors Beating Cancer Plan’ which would cover and the prevention and control of which the entire cycle of the disease starting from would benefit the majority of citizens. In prevention and early diagnosis to treatment 2020 the Commission announced the and quality of life of patients and ‘Europe’s Beating Cancer Plan’ which survivors. The measures should benefit would cover the entire cycle of the disease from the Programme and from Horizon starting from prevention and early Europe’s Mission on Cancer. diagnosis to treatment and quality of life of patients and survivors. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer. The Programme should ensure that patients living with other major chronic diseases such as cardiovascular disease, chronic respiratory disease, diabetes and mental health conditions benefit from it in a proportionate manner.

Or. en

PE653.822v01-00 142/276 AM\1207705EN.docx EN Amendment 298 Cristian-Silviu Buşoi

Proposal for a regulation Recital 19

Text proposed by the Commission Amendment

(19) Cancer is the second leading cause (19) Cancer is the second leading cause of mortality in the Member States after of mortality in the Member States after cardiovascular diseases. It is also one of cardiovascular diseases. It is also one of non-communicable diseases that share non-communicable diseases that share common risk factors and the prevention common risk factors and the prevention and control of which would benefit the and control of which would benefit the majority of citizens. In 2020 the majority of citizens. Currently no broadly Commission announced the ‘Europe’s accepted tools such as a “Cancer Beating Cancer Plan’ which would cover Dashboard” exist which can serve to the entire cycle of the disease starting from measure progress (e.g. EU Cancer prevention and early diagnosis to treatment Targets) and address inequalities (e.g. in and quality of life of patients and Central and South-Eastern Europe versus survivors. The measures should benefit the rest of Europe). In 2020 the from the Programme and from Horizon Commission announced the ‘Europe’s Europe’s Mission on Cancer. Beating Cancer Plan’ which would cover the entire cycle of the disease starting from prevention and early diagnosis to treatment and quality of life of patients and survivors. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer, in particular by initiatives which support the mid- and long-term goals of the Plan. The actions on cancer should equally address its common shared risk factors and synergies with other major non-communicable diseases such as neurological disorders, as well as reflect upon devising a template for other major disease areas based on the ‘Europe’s Beating Cancer Plan’.

Or. en

Amendment 299 Luisa Regimenti, Joëlle Mélin, Catherine Griset, Simona Baldassarre, Danilo Oscar Lancini, Lucia Vuolo, Silvia Sardone, Vincenzo Sofo, Marco Dreosto, Aurelia Beigneux

AM\1207705EN.docx 143/276 PE653.822v01-00 EN Proposal for a regulation Recital 19

Text proposed by the Commission Amendment

(19) Cancer is the second leading cause (19) Cancer is the second leading cause of mortality in the Member States after of mortality in the Member States after cardiovascular diseases. It is also one of cardiovascular diseases. It is also one of non-communicable diseases that share non-communicable diseases that share common risk factors and the prevention common risk factors and the prevention and control of which would benefit the and control of which would benefit the majority of citizens. In 2020 the majority of citizens. In 2020 the Commission announced the ‘Europe’s Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover Beating Cancer Plan’ which would cover the entire cycle of the disease starting from the entire cycle of the disease starting from prevention and early diagnosis to treatment prevention and early diagnosis to treatment and quality of life of patients and and quality of life of patients and survivors. The measures should benefit survivors. The measures should benefit from the Programme and from Horizon from the Programme and from Horizon Europe’s Mission on Cancer. Europe’s Mission on Cancer. The actions on cancer should also address its common risk factors and synergies with other major non-communicable diseases, such as neurological diseases, and consider devising a template for other major disease areas based on the ‘Europe’s Beating Cancer Plan’.

Or. it

Amendment 300 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 19

Text proposed by the Commission Amendment

(19) Cancer is the second leading cause (19) Cancer is the second leading cause of mortality in the Member States after of mortality in the Member States after cardiovascular diseases. It is also one of cardiovascular diseases. It is also one of non-communicable diseases that share several non-communicable diseases that common risk factors and the prevention share common risk factors. Addressing the and control of which would benefit the prevention of cancer along with other majority of citizens. In 2020 the NCDs in a coordinated fashion and the

PE653.822v01-00 144/276 AM\1207705EN.docx EN Commission announced the ‘Europe’s prevention and control of which would Beating Cancer Plan’ which would cover benefit the majority of citizens. In 2020 the the entire cycle of the disease starting from Commission announced the ‘Europe’s prevention and early diagnosis to treatment Beating Cancer Plan’ which would cover and quality of life of patients and the entire cycle of the disease starting from survivors. The measures should benefit prevention and early diagnosis to treatment from the Programme and from Horizon and quality of life of patients and survivors Europe’s Mission on Cancer. also improving palliative care and pain management. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer and should endeavour to include cancer action into a broader NCD framework to move away from a disease-centred approach and towards a patient-focused approach.

Or. en

Amendment 301 Kateřina Konečná

Proposal for a regulation Recital 19

Text proposed by the Commission Amendment

(19) Cancer is the second leading cause (19) Cancer is the second leading cause of mortality in the Member States after of mortality in the Member States after cardiovascular diseases. It is also one of cardiovascular diseases. It is also one of non-communicable diseases that share non-communicable diseases that share common risk factors and the prevention common risk factors and the prevention and control of which would benefit the and control of which would benefit the majority of citizens. In 2020 the majority of citizens. In 2020 the Commission announced the ‘Europe’s Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover Beating Cancer Plan’ which would cover the entire cycle of the disease starting from the entire cycle of the disease starting from prevention and early diagnosis to treatment prevention and early diagnosis to treatment and quality of life of patients and and quality of life of patients and survivors. The measures should benefit survivors. The measures should benefit from the Programme and from Horizon from the Programme and from Horizon Europe’s Mission on Cancer. Europe’s Mission on Cancer. The actions on cancer should equally address its common shared risk factors and synergies with other major non-communicable diseases such as neurological disorders, as well as reflect upon devising a template for other major disease areas based on the

AM\1207705EN.docx 145/276 PE653.822v01-00 EN ‘Europe’s Beating Cancer Plan’.

Or. en

Amendment 302 Bartosz Arłukowicz, Jarosław Duda

Proposal for a regulation Recital 19

Text proposed by the Commission Amendment

(19) Cancer is the second leading cause (19) Cancer is the second leading cause of mortality in the Member States after of mortality in the Member States after cardiovascular diseases. It is also one of cardiovascular diseases. It is also one of non-communicable diseases that share non-communicable diseases that share common risk factors and the prevention common risk factors and the prevention and control of which would benefit the and control of which would benefit the majority of citizens. In 2020 the majority of citizens. In 2020 the Commission announced the ‘Europe’s Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover Beating Cancer Plan’ which would cover the entire cycle of the disease starting from the entire cycle of the disease starting from prevention and early diagnosis to treatment prevention and early diagnosis to treatment and quality of life of patients and and quality of life of patients and survivors. The measures should benefit survivors. The measures should benefit from the Programme and from Horizon from the Programme and from Horizon Europe’s Mission on Cancer. Europe’s Mission on Cancer. The actions on cancer should also address its common, shared risk factors and synergies with other major non- communicable diseases, such as neurological disorders, and consider devising a template for other major disease areas.

Or. pl

Amendment 303 Margarita de la Pisa Carrión

Proposal for a regulation Recital 19

PE653.822v01-00 146/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(19) Cancer is the second leading cause (19) Cancer is the second leading cause of mortality in the Member States after of mortality in the Member States after cardiovascular diseases. It is also one of cardiovascular diseases. It is also one of non-communicable diseases that share non-communicable diseases that share common risk factors and the prevention common risk factors and the prevention and control of which would benefit the and control of which would benefit the majority of citizens. In 2020 the majority of citizens. In 2020 the Commission announced the ‘Europe’s Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover Beating Cancer Plan’ which would cover the entire cycle of the disease starting from the entire cycle of the disease starting from prevention and early diagnosis to treatment prevention and early diagnosis to treatment and quality of life of patients and and quality of life of patients and survivors. The measures should benefit survivors, as well as better palliative care from the Programme and from Horizon and pain management. The measures Europe’s Mission on Cancer. should benefit from the Programme and from Horizon Europe’s Mission on Cancer. The EU is in a position to take the lead in providing humanitarian support to terminally ill patients by developing and implementing palliative care measures.

Or. es

Amendment 304 Linea Søgaard-Lidell, Jan Huitema

Proposal for a regulation Recital 19

Text proposed by the Commission Amendment

(19) Cancer is the second leading cause (19) Cancer causes 26 % of all deaths of mortality in the Member States after in EU and is thereby the second leading cardiovascular diseases. It is also one of cause of mortality in the Member States non-communicable diseases that share after cardiovascular diseases that represent common risk factors and the prevention 36 % of all deaths in the EU. It is also one and control of which would benefit the of non-communicable diseases that share majority of citizens. In 2020 the common risk factors such as obesity for 20 Commission announced the ‘Europe’s % of cancers and the prevention and Beating Cancer Plan’ which would cover control of which would benefit the the entire cycle of the disease starting from majority of citizens. In 2020 the prevention and early diagnosis to treatment Commission announced the ‘Europe’s and quality of life of patients and Beating Cancer Plan’ which would cover survivors. The measures should benefit the entire cycle of the disease starting from

AM\1207705EN.docx 147/276 PE653.822v01-00 EN from the Programme and from Horizon prevention and early diagnosis to treatment Europe’s Mission on Cancer. and quality of life of patients and survivors. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer.

Or. en

Amendment 305 Sirpa Pietikäinen

Proposal for a regulation Recital 19 a (new)

Text proposed by the Commission Amendment

(19a) It is well recognised that cancer is often diagnosed late, which means that fewer treatment options are available for people affected by an advanced stage of the disease. If more patients were diagnosed earlier, it could lead to much more effective treatment outcomes, better quality of life, as well as improved overall survival rates. An earlier diagnosis means also a reduction in the healthcare burden. Compared to early diagnosis, cancer screening is a distinct and more complex public health strategy that mandates additional resources, infrastructure and coordination. When planned effectively, appropriately financed and implemented, screening can reduce deaths from cancer and, in the case of some cancer types, can also reduce the risk of developing cancer. The Programme should therefore contribute to the investment in early diagnosis and screening, and to promotion and awareness raising in relation to the benefits of such early diagnosis and screening. The EU should have extensive cancer screening recommendations and guidelines for all major cancers to be implemented in all Member States.

PE653.822v01-00 148/276 AM\1207705EN.docx EN Or. en

Amendment 306 Michèle Rivasi

Proposal for a regulation Recital 19 a (new)

Text proposed by the Commission Amendment

(19a) It is well recognised that cancer is often diagnosed late, which means that fewer treatment options are available for people affected by an advanced stage of the disease. If more patients were diagnosed earlier, it could lead to much more effective treatment outcomes, better quality of life, as well as improved overall survival rates. An earlier diagnosis means also a reduction in the healthcare burden. Compared to early diagnosis, cancer screening is a distinct and more complex public health strategy that mandates additional resources, infrastructure and coordination. When evidence-based, planned effectively, appropriately financed and implemented, screening can reduce deaths from cancer and, in the case of some cancer types, can also reduce the risk of developing cancer. The Programme should therefore contribute to the investment in early diagnosis and evidence-based screening, and to promotion and awareness raising in relation to the benefits and adverse effects of such early diagnosis and screening.

Or. en

Justification

Not all screening is beneficial. Sweden has stopped prostate cancer screening for over 50's because it is considered unethical. Health screening should be ethical and evidence-based.

AM\1207705EN.docx 149/276 PE653.822v01-00 EN Amendment 307 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Recital 19 a (new)

Text proposed by the Commission Amendment

(19a) Under Article 153 TFEU, the Union is to support and complement the activities of Member States concerning improvement of the working environment, and protection of workers' health, safety and working conditions. Considering the large amount of time that the workers spend in their workplaces and the possible risk they could have, such as exposure to health hazard substances and carcinogens and to repeated movements, leading to a high burden of incapacity and number of work days lost, which in turn has consequences for the individual, family and society. The Programme should also reflect the importance of occupational health and its impact on health workers and societies. The Commission should work with Member States to create new legislation to improve workers health conditions, improve their working conditions, the balance between work and life, promote wellbeing and better mental health, prevent early-retirement due to ill health and poor health management.

Or. en

Amendment 308 Mick Wallace

Proposal for a regulation Recital 19 a (new)

PE653.822v01-00 150/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(19a) While the Union currently has a strong focus on cancer as expressed in ‘Europe’s Beating Cancer Plan’ and Horizon Europe’s Mission on Cancer, the Programme must ensure that patients living with other major chronic diseases such as cardiovascular disease, chronic respiratory disease, diabetes and mental health conditions benefit from it in a proportionate manner. In Europe, chronic diseases are responsible for 77% of the total disease burden (measured in DALYs = disability-adjusted life years). Of these, cardiovascular disease makes up 23%, neuropsychiatric conditions 20% and cancer 11%. The Programme should ensure that the actions it supports will benefit equitably all chronic disease patients. In that context, it should be acknowledged that the Programme goes beyond the current EU mandate, running well into the next EU mandate as it comes to an end in 2027.

Or. en

Justification

In Europe, chronic diseases are responsible for 77% of the total disease burden (measured in DALYs = disability-adjusted life years). Of these, cardiovascular disease makes up 23%, neuropsychiatric conditions 20% and cancer 11%.The Programme should ensure that the actions it supports will benefit equitably all chronic disease patients. In that context it should be acknowledged that the Programme goes beyond the current EU mandate, running well into the next EU mandate as it comes to an end in 2027.

Amendment 309 Cristian-Silviu Buşoi

Proposal for a regulation Recital 19 a (new)

Text proposed by the Commission Amendment

(19a) A recent study by authors from

AM\1207705EN.docx 151/276 PE653.822v01-00 EN IARC published in the February 2020 edition of the Lancet Global Health Journal, highlights a crucial need for resources directed towards cancer prevention programmes that target infection, namely helicobacter pylori, human papillomavirus, Hepatitis B virus and Hepatitis C virus, particularly in high-risk populations. Such interventions can markedly reduce the increasing cancer burden and associated mortality. The Programme should just ensure that will promote measures to tackle infectious diseases, helping their prevention, through vaccination, if available, awareness raising, early diagnosis/screening, and linkage to care, with a view to promoting the prevention of cancer as a key European Commission goal.

Or. en

Amendment 310 Antoni Comín i Oliveres

Proposal for a regulation Recital 19 a (new)

Text proposed by the Commission Amendment

(19a) There is plenty of scientific evidence that shows that health prevention and promotion policies (public health policies) are central to guaranteeing the right to health of citizens, and those are also the most efficient in terms of cost effectiveness. However, even today most of the budgets of the health systems of the majority of Member States are given very little space to policies for the prevention and promotion of health. The COVID-19 pandemic has firmly confirmed the importance of public health policies for our societies. For this reason, it is necessary that the projects of the

PE653.822v01-00 152/276 AM\1207705EN.docx EN EU4Health programme accompany Member States to reformulate the budgets of their health systems in order to fulfil greater financial strength to these policies.

Or. en

Amendment 311 Véronique Trillet-Lenoir

Proposal for a regulation Recital 19 a (new)

Text proposed by the Commission Amendment

(19a) The programme could participate to the establishment of a European Cancer Institute (ECI) which would provide a platform for the implementation of the standards of practices through European Reference Cancer Networks, the collection of clinical data among centres from all participating countries across Europe and beyond and the prioritisation of academic and clinical research programmes of excellence. The programme could support the development of national cancer registries in all Member States which are essential to provide comparable data on cancer.

Or. en

Amendment 312 Luisa Regimenti, Joëlle Mélin, Catherine Griset, Simona Baldassarre, Danilo Oscar Lancini, Lucia Vuolo, Silvia Sardone, Vincenzo Sofo, Marco Dreosto, Aurelia Beigneux

Proposal for a regulation Recital 19 a (new)

Text proposed by the Commission Amendment

(19a) Heart attacks and strokes often occur in people previously undiagnosed

AM\1207705EN.docx 153/276 PE653.822v01-00 EN with cardiovascular diseases. Many of these are due to undetected genetic conditions, such as familial hypercholesterolaemia, arrhythmias, congenital heart disease and cardiomyopathies, and conditions such as hypertension. The Programme should support the development of policies and interventions to identify and manage individuals at high risk of developing cardiovascular disease in order to prevent the onset of the disease and reduce mortality.

Or. it

Amendment 313 César Luena

Proposal for a regulation Recital 19 a (new)

Text proposed by the Commission Amendment

(19a) Late diagnosis of cancer and Structural Heart Diseases reduces treatment options available for people affected by an advanced stage of the disease. Early diagnosis is crucial for effective treatment outcomes, better quality of life and reduction of the healthcare burden. The Programme should therefore contribute to the investment in early diagnosis and screening, and to the promotion and awareness raising in relation to the benefits of such early diagnosis and screening for cancer and Structural Heart Diseases.

Or. en

Amendment 314 Pernille Weiss

PE653.822v01-00 154/276 AM\1207705EN.docx EN Proposal for a regulation Recital 19 a (new)

Text proposed by the Commission Amendment

(19a) Obesity is the fourth largest direct cause of premature mortality in the EU. In this context, obesity acts as a gateway chronic disease to the onset of 80% of Type 2 Diabetes cases and 20%of cancers. Obesity has been recognised as one of the high risk pre-existing chronic diseases in the EU and must be subject to evidence- based policymaking, which should be aligned with international standards and national implementation trends.

Or. en

Amendment 315 Linea Søgaard-Lidell, Frédérique Ries, Jan Huitema

Proposal for a regulation Recital 19 a (new)

Text proposed by the Commission Amendment

(19a) The Programme should ensure that patients living with and suffering from any chronic disease such as cardiovascular disease, cancer, obesity, chronic respiratory disease, neurologic disorder, diabetes or mental health disorder benefit from it in a proportionate manner.

Or. en

Amendment 316 Cristian-Silviu Buşoi

Proposal for a regulation Recital 19 b (new)

AM\1207705EN.docx 155/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(19b) The IARC shows that more than 35,000 children and young people are diagnosed with cancer and over than 6,000 young patients die annually in Europe. Paediatric cancers are a category of age- and biologically specific rare malignancies that cannot be appropriately addressed by extrapolation of adult cancer approaches and require a dedicated effort across the research and care continuum. There is a lack of innovative therapies to treat children with cancer. Even for older off-patent medicines used off-label on children, there are still pronounced access issues including shortages across the Union and budget limitations in some Member States, as well as major differences among countries in pain control accessibility for children undergoing treatment for cancer. Hence, there is an urgent need to appropriately revise the regulatory environment so that the needs of children and adolescents are met. The Programme should therefore provide for actions in this regard, in particular aiming to reinforce Regulation (EC) No 1901/2006 of the European Parliament and of the Council. and support cross-border research collaboration by granting appropriate allocations and to amend Article 10 of the directive 2001/83/EC, in order to include a paragraph to stimulate innovation on the off-patented medicines.

Or. en

Amendment 317 Michèle Rivasi

Proposal for a regulation Recital 19 b (new)

PE653.822v01-00 156/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(19b) The health workforce has a vital role in building resilient health systems and in reaching the highest attainable standard of health. The Programme should therefore underpin the Commission’s work on effective, accessible and resilient healthcare and health systems, and support the development and implementation of a strategy on the health workforce. In synergy with ESF+ and in particular EaSI, the Programme should provide under the Strategy the means for harmonized training and education for the purpose of improving the curricula of health professionals, in particular with regard to health promotion and disease prevention as well as digital skills, in order to obtain a patient-oriented and outcome-based health approach. The Programme should also support, via the Strategy, Member States to address the brain drain and migration of the healthcare workforce from less-developed countries and implement retention policies. Being able to deliver high quality, personalised, targeted and integrated care, and improve health service coverage depends on the availability, accessibility, acceptability, adaptability and quality of the health workforce.

Or. en

Amendment 318 Antoni Comín i Oliveres

Proposal for a regulation Recital 19 b (new)

AM\1207705EN.docx 157/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(19b) Likewise, it is absolutely necessary to remember that these prevention and promotion strategies concern all sectoral policies: fiscal, commercial, economic, educational, housing, cultural, social assistance, etc. "Health in all policies" (HiAP) should be a non-negotiable principle of all public policies. An instrument already used at the national level is the so-called Health Test to assess the health impact of the different sectoral policies. It is necessary to deploy a Health Test methodology of all the programmes managed by the Union.

Or. en

Amendment 319 Mick Wallace

Proposal for a regulation Recital 19 b (new)

Text proposed by the Commission Amendment

(19b) Heart attacks and strokes often occur in people previously undiagnosed with cardiovascular disease. Many of these are due to undetected genetic conditions, such as familial hypercholesterolaemia, arrhythmias, congenital heart disease and cardiomyopathies and conditions, such as hypertension. The Programme should support the development of policies and interventions for reaching out to and managing individuals at high risk of developing cardiovascular disease to prevent the onset of the disease and reduce mortality.

Or. en

PE653.822v01-00 158/276 AM\1207705EN.docx EN Justification

A sizeable number of premature deaths from cardiovascular disease (CVD), just like from cancer and other chronic diseases, can be prevented by controlling the main risk factors: tobacco, unhealthy diet and physical inactivity. To tackle CVD comprehensively both primary and secondary prevention is needed.

Amendment 320 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Christel Schaldemose

Proposal for a regulation Recital 19 b (new)

Text proposed by the Commission Amendment

(19b) While the Union currently has a strong focus on cancer as expressed in ‘Europe’s Beating Cancer Plan’ and Horizon Europe’s Mission on Cancer, the Programme should ensure that patients living with other major chronic diseases such as cardiovascular disease, chronic respiratory disease, diabetes and mental health conditions benefit from it in a proportionate manner.

Or. en

Amendment 321 Mick Wallace

Proposal for a regulation Recital 19 c (new)

Text proposed by the Commission Amendment

(19c) A crucial part of treatment for cardiovascular disease is rehabilitation after an event, including counselling, medical treatment, exercise and psychological support. These programmes help prevent recurrence, optimise quality of life, reintegrate patients into the job

AM\1207705EN.docx 159/276 PE653.822v01-00 EN market and reduce the burden on health services by reducing hospital readmissions. Although the considerable benefits of cardiac and stroke rehabilitation for patients, as well as the wider society, are well-documented, access to and uptake of quality rehabilitation is patchy in most of the Union’s Member States and is considered an underutilised resource. The Programme should support increased uptake of rehabilitation and secondary prevention.

Or. en

Justification

The benefits that rehabilitation bestows on patients as well as the wider society are considerable. Cardiovascular rehabilitation must be an integral part of the patient’s treatment plan and must be accessible by all eligible patients throughout the Union. Cardiovascular rehabilitation increases the chances of patients getting back to work and have the potential to reduce disability allowances.

Amendment 322 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 19 c (new)

Text proposed by the Commission Amendment

(19c) A crucial part of treatment of diseases is rehabilitation, including counselling, medical treatment, exercise and psychological support. These programmes help prevent recurrence, optimise quality of life, reintegrate patients into the job market and reduce the burden on health services by reducing hospital readmissions. Although there are considerable benefits for patients, as well as the wider society, the access to and uptake of quality rehabilitation is patchy in most of the Member States and is

PE653.822v01-00 160/276 AM\1207705EN.docx EN considered an underutilised resource. The Programme should support increased uptake of rehabilitation and secondary prevention reducing the burden of diseases.

Or. en

Amendment 323 Christian Ehler on behalf of the EPP Group Dan Nica on behalf of the S&D Group Martina Dlabajová on behalf of the Renew Group Ville Niinistö on behalf of the Greens/EFA Group Marisa Matias on behalf of the GUE/NGL Group Cristian-Silviu Buşoi

Proposal for a regulation Recital 19 c (new)

Text proposed by the Commission Amendment

(19c) It is well recognised that cancer is often diagnosed late, which means that fewer treatment options are available for people affected by an advanced stage of the disease. The Programme should therefore contribute to the investment in early diagnosis and screening, and to promotion and awareness raising in relation to the benefits of early diagnosis and screening, in line with or going beyond WHO, UN and EU recommendations, and in synergy with Horizon Europe, its Mission on Cancer and the relevant partnerships.

Or. en

Amendment 324 Christian Ehler

AM\1207705EN.docx 161/276 PE653.822v01-00 EN on behalf of the EPP Group Dan Nica on behalf of the S&D Group Martina Dlabajová on behalf of the Renew Group Ville Niinistö on behalf of the Greens/EFA Group Marisa Matias on behalf of the GUE/NGL Group Cristian-Silviu Buşoi

Proposal for a regulation Recital 19 d (new)

Text proposed by the Commission Amendment

(19d) Paediatric cancers are a category of age- and biologically-specific rare malignancies that cannot be appropriately addressed by extrapolation of adult cancer approaches and require a dedicated effort across the research and care continuum. The Programme should provide for actions oriented at paediatric cancer, in particular aiming to address the limitations of the Regulation (EC) No 1901/2006 of the European Parliament and of the Council1a in this disease area and support cross-border research collaboration by granting appropriate allocations in synergy with Horizon Europe, its Mission on Cancer and the relevant partnerships. ______1a Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance) (OJ L 378, 27.12.2006, p. 1).

Or. en

PE653.822v01-00 162/276 AM\1207705EN.docx EN Amendment 325 Joanna Kopcińska

Proposal for a regulation Recital 20

Text proposed by the Commission Amendment

(20) The Programme will work in (20) The Programme will work in synergy and complementarity with other synergy and complementarity with other EU policies, programmes and funds such EU policies, programmes and funds such as actions implemented under the Digital as actions implemented under the Digital Europe Programme, Horizon Europe, Europe Programme, Horizon Europe, rescEU reserve under the Union Civil rescEU reserve under the Union Civil Protection Mechanism, Emergency Protection Mechanism, Emergency Support Instrument, European Social Support Instrument, European Social Fund+ (ESF+, including as regards Fund+ (ESF+, including as regards synergies on better protecting the health synergies on better protecting the health and safety of millions of workers in the and safety of millions of workers in the EU), including the Employment and Social EU), including the Employment and Social Innovation Strand (EaSI), the InvestEU Innovation Strand (EaSI), the InvestEU fund, Single Market Programme, European fund, Single Market Programme, European Regional Development Fund (ERDF), Regional Development Fund (ERDF), Recovery and Resilience Facility including Recovery and Resilience Facility including the Reform Delivery Tool, Erasmus, the Reform Delivery Tool, Erasmus, European Solidarity Corps, Support to European Solidarity Corps, Support to mitigate Unemployment Risks in an mitigate Unemployment Risks in an Emergency (SURE), and EU external Emergency (SURE), and EU external action instruments, such as the action instruments, such as the Neighbourhood, Development and Neighbourhood, Development and International Cooperation Instrument and International Cooperation Instrument and the Instrument for Pre-accession the Instrument for Pre-accession Assistance III. Where appropriate, Assistance III. Where appropriate, common rules will be established in view common rules will be established in view of ensuring consistency and of ensuring consistency and complementarity between funds, while complementarity between funds, avoiding making sure that specificities of these any overlap or duplication of financing, policies are respected, and in view of while making sure that specificities of aligning with the strategic requirements of these policies are respected, and in view of these policies, programmes and funds, such aligning with the strategic requirements of as the enabling conditions under ERDF and these policies, programmes and funds, such ESF+. as the enabling conditions under ERDF and ESF+.

Or. en

AM\1207705EN.docx 163/276 PE653.822v01-00 EN Amendment 326 Pascal Arimont, Cindy Franssen, Esther de Lange

Proposal for a regulation Recital 20

Text proposed by the Commission Amendment

(20) The Programme will work in (20) The Programme will work in synergy and complementarity with other synergy and complementarity with other EU policies, programmes and funds such EU policies, programmes and funds such as actions implemented under the Digital as actions implemented under the Digital Europe Programme, Horizon Europe, Europe Programme, Horizon Europe, rescEU reserve under the Union Civil rescEU reserve under the Union Civil Protection Mechanism, Emergency Protection Mechanism, Emergency Support Instrument, European Social Support Instrument, European Social Fund+ (ESF+, including as regards Fund+ (ESF+, including as regards synergies on better protecting the health synergies on better protecting the health and safety of millions of workers in the and safety of millions of workers in the EU), including the Employment and Social EU), including the Employment and Social Innovation Strand (EaSI), the InvestEU Innovation Strand (EaSI), the InvestEU fund, Single Market Programme, European fund, Single Market Programme, European Regional Development Fund (ERDF), Regional Development Fund (ERDF) Recovery and Resilience Facility including including Interreg, Recovery and the Reform Delivery Tool, Erasmus, Resilience Facility including the Reform European Solidarity Corps, Support to Delivery Tool, Erasmus, European mitigate Unemployment Risks in an Solidarity Corps, Support to mitigate Emergency (SURE), and EU external Unemployment Risks in an Emergency action instruments, such as the (SURE), and EU external action Neighbourhood, Development and instruments, such as the Neighbourhood, International Cooperation Instrument and Development and International the Instrument for Pre-accession Cooperation Instrument and the Instrument Assistance III. Where appropriate, for Pre-accession Assistance III. Where common rules will be established in view appropriate, common rules will be of ensuring consistency and established in view of ensuring consistency complementarity between funds, while and complementarity between funds, while making sure that specificities of these making sure that specificities of these policies are respected, and in view of policies are respected, and in view of aligning with the strategic requirements of aligning with the strategic requirements of these policies, programmes and funds, such these policies, programmes and funds, such as the enabling conditions under ERDF and as the enabling conditions under ERDF and ESF+. ESF+.

Or. en

Amendment 327 Joanna Kopcińska

PE653.822v01-00 164/276 AM\1207705EN.docx EN Proposal for a regulation Recital 20 a (new)

Text proposed by the Commission Amendment

(20a) The health workforce has a vital role in building resilient health systems and in reaching the highest attainable standard of health. The Programme should therefore underpin the Commission’s work on effective, accessible and resilient healthcare and health systems, and support the development and implementation of a strategy on the health workforce. In synergy with European Social Fund Plus (ESF+), and in particular Employment and Social Innovation (EaSI), the Programme should provide under the Strategy the means for harmonized training and education for the purpose of improving the curricula of health professionals and their digital skills, in order to obtain a patient-oriented and outcome-based health approach. The Programme should also support, via the Strategy, Member States to address the brain drain and migration of the healthcare workforce from Member States of the eastern flank of the European Union and implement retention policies. Being able to deliver high quality, standardised, targeted and integrated care, and improve health service coverage depends on the availability, accessibility, acceptability, adaptability and quality of the health workforce.

Or. en

Amendment 328 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

AM\1207705EN.docx 165/276 PE653.822v01-00 EN Proposal for a regulation Recital 20 a (new)

Text proposed by the Commission Amendment

(20a) The programme should encompass a “Health in all policies” and “Health in all fundings” approaches in its implementation and evaluation. In the programme’s framework, the Commission should proceed to a systematic health impact assessment, built on cross-sectorial indicators, of all EU policies and fundings in order to evaluate their impact on improving health and well-being of our citizens.

Or. en

Amendment 329 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 20 a (new)

Text proposed by the Commission Amendment

(20a) The programme should support vulnerable population groups that have more difficulty in accessing healthcare, due to their socio-economic or geographic characteristics. Synergies between the Programme and ESF+ and ERDF are crucial, and the Commission should take into account the particularity of remotes areas and more concretely, the outermost regions based on Article 349 TFEU.

Or. en

Amendment 330 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller,

PE653.822v01-00 166/276 AM\1207705EN.docx EN Susana Solís Pérez, Chrysoula Zacharopoulou, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 20 b (new)

Text proposed by the Commission Amendment

(20b) The programme should guarantee a strong involvement of the civil society (in particular patients' associations) and academics (in particular healthcare professionals' societies) to ensure a balanced representation and participation in achieving public health goals. European health organizations should contribute to the implementation and the evaluation of the programme.

Or. en

Amendment 331 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 20 c (new)

Text proposed by the Commission Amendment

(20c) The evaluations of the last and current programmes should be taken into consideration in the framework of the Conference on the Future of Europe, which could come forward with clear proposals to strengthen the European Health Policy.

Or. en

Amendment 332 Jessica Polfjärd

Proposal for a regulation Recital 21

AM\1207705EN.docx 167/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(21) In accordance with Article 114 (21) In accordance with Article 114 TFEU, a high level of health protection TFEU, a high level of health protection should be ensured in the legislation should be ensured in the legislation adopted by the Union for the establishment adopted by the Union for the establishment and the functioning of the internal market. and the functioning of the internal market. On the basis of Article 114 TFEU and On the basis of Article 114 TFEU and point (c) of Article 168(4) TFEU, a point (c) of Article 168(4) TFEU, a considerable body of Union acquis was considerable body of Union acquis was developed which guarantees the high developed which guarantees the high standards of quality and safety for standards of quality and safety for medicinal products and medical devices. medicinal products and medical devices. Given the rising healthcare demand, Given the rising healthcare demand, Member States’ healthcare systems face Member States’ healthcare systems face challenges in the availability and challenges in the availability, accessibility affordability of medicines and medical and affordability of medicines and medical devices. To ensure a better public health devices. To ensure a better public health protection as well as the safety and protection as well as the safety and empowerment of patients in the Union, it is empowerment of patients in the Union, it is essential that patients and health systems essential that patients and health systems have access to high quality healthcare have access to high quality healthcare products and can fully benefit from them. products and can fully benefit from them. Such access could be promoted through improved coordination between Member States and through the maintenance of an open and well–functioning internal market at all times.

Or. en

Amendment 333 Pascal Arimont, Cindy Franssen, Esther de Lange

Proposal for a regulation Recital 21

Text proposed by the Commission Amendment

(21) In accordance with Article 114 (21) In accordance with Article 114 TFEU, a high level of health protection TFEU, a high level of health protection should be ensured in the legislation should be ensured in the legislation adopted by the Union for the establishment adopted by the Union for the establishment and the functioning of the internal market. and the functioning of the internal market. On the basis of Article 114 TFEU and On the basis of Article 114 TFEU and point (c) of Article 168(4) TFEU, a point (c) of Article 168(4) TFEU, a

PE653.822v01-00 168/276 AM\1207705EN.docx EN considerable body of Union acquis was considerable body of Union acquis was developed which guarantees the high developed which guarantees the high standards of quality and safety for standards of quality and safety for medicinal products and medical devices. medicinal products and medical devices. Given the rising healthcare demand, Given the rising healthcare demand, Member States’ healthcare systems face Member States’ healthcare systems face challenges in the availability and challenges in the availability and affordability of medicines and medical affordability of medicines and medical devices. To ensure a better public health devices. To ensure a better public health protection as well as the safety and protection as well as the safety and empowerment of patients in the Union, it is empowerment of patients in the Union, it is essential that patients and health systems essential that patients and health systems have access to high quality healthcare have access to high quality healthcare products and can fully benefit from them. services and products, including in a cross-border context, and can fully benefit from them.

Or. en

Amendment 334 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 21

Text proposed by the Commission Amendment

(21) In accordance with Article 114 (21) In accordance with Article 114 TFEU, a high level of health protection TFEU, a high level of health protection should be ensured in the legislation should be ensured in the legislation adopted by the Union for the establishment adopted by the Union for the establishment and the functioning of the internal market. and the functioning of the internal market. On the basis of Article 114 TFEU and On the basis of Article 114 TFEU and point (c) of Article 168(4) TFEU, a point (c) of Article 168(4) TFEU, a considerable body of Union acquis was considerable body of Union acquis was developed which guarantees the high developed which guarantees the high standards of quality and safety for standards of quality and safety for medicinal products and medical devices. medicinal products and medical devices. Given the rising healthcare demand, Given the rising healthcare demand, Member States’ healthcare systems face Member States’ healthcare systems face challenges in the availability and challenges in the availability and affordability of medicines and medical affordability of medicines and medical devices. To ensure a better public health devices. To ensure a better public health protection as well as the safety and protection as well as the safety and empowerment of patients in the Union, it is empowerment of patients in the Union, it is

AM\1207705EN.docx 169/276 PE653.822v01-00 EN essential that patients and health systems essential that patients and health systems have access to high quality healthcare have access to sustainable, efficient, products and can fully benefit from them. equitable and high quality healthcare products and can fully benefit from them.

Or. en

Amendment 335 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 21

Text proposed by the Commission Amendment

(21) In accordance with Article 114 (21) In accordance with Article 114 TFEU, a high level of health protection TFEU, a high level of health protection should be ensured in the legislation should be ensured in the legislation adopted by the Union for the establishment adopted by the Union for the establishment and the functioning of the internal market. and the functioning of the internal market. On the basis of Article 114 TFEU and On the basis of Article 114 TFEU and point (c) of Article 168(4) TFEU, a point (c) of Article 168(4) TFEU, a considerable body of Union acquis was considerable body of Union acquis was developed which guarantees the high developed which guarantees the high standards of quality and safety for standards of quality and safety for medicinal products and medical devices. medicinal products and medical devices. Given the rising healthcare demand, Given the rising healthcare demand, Member States’ healthcare systems face Member States’ healthcare systems face challenges in the availability and challenges in the availability and affordability of medicines and medical affordability of medicines and medical devices. To ensure a better public health devices. To ensure a better public health protection as well as the safety and protection as well as the safety and empowerment of patients in the Union, it is empowerment of patients in the Union, it is essential that patients and health systems essential that patients and health systems have access to high quality healthcare have access to affordable high quality products and can fully benefit from them. healthcare products and can fully benefit from them.

Or. en

Amendment 336 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, María

PE653.822v01-00 170/276 AM\1207705EN.docx EN Soraya Rodríguez Ramos

Proposal for a regulation Recital 21 a (new)

Text proposed by the Commission Amendment

(21a) The programme should contribute to the strengthening of the European Medicines Market to speed up equitable access to medicines, make care more affordable, maximize savings in national health budgets and avoid obstacles for generic and biosimilar use.

Or. en

Amendment 337 Christian Ehler on behalf of the EPP Group Dan Nica on behalf of the S&D Group Martina Dlabajová on behalf of the Renew Group Cristian-Silviu Buşoi

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor and mitigate medicines, medical devices and other shortages of medicines, medical devices healthcare products and to ensure greater and other healthcare products and to ensure availability and affordability of those greater availability and affordability of products while limiting the dependency of those products while limiting the their supply chains on third countries. In dependency of their supply chains on third particular, in order to address unmet countries. In particular, in order to address medical needs, the Programme should unmet medical needs, the Programme provide support to clinical trials so as to should provide support to clinical trials so speed up the development, authorisation as to speed up the development, and access to innovative and effective authorisation and access to innovative and medicines, promote incentives to develop effective medicines and treatment, such medicinal products as antimicrobials promote incentives to boost the production and foster the digitial transformation of capacity for antimicrobials, personalized healthcare products and platforms for treatment and vaccination, and foster the

AM\1207705EN.docx 171/276 PE653.822v01-00 EN monitoring and collecting information on digital transformation of healthcare medicines. 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 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, including innovations in rare diseases, in healthcare systems and clinical practice. In 2020, the Commission announced the ‘Pharmaceutical strategy for Europe’ with the overall goal of helping to ensure the Union’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry’s innovation efforts in the Union and globally. The Programme should support the implementation of the Pharmaceutical strategy for Europe to foster a competitive pharmaceutical industry taking into account that EU remains by far the world’s first manufacturing region of active ingredients for patent medicines.

Or. en

Amendment 338 Michèle Rivasi

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor shortages of medicines, medical devices and other medicines, medical devices and other healthcare products and to ensure greater healthcare products and to ensure greater availability and affordability of those availability and affordability of those products while limiting the dependency of products while limiting the dependency of their supply chains on third countries. In their supply chains on third countries. In particular, in order to address unmet particular, in order to address unmet

PE653.822v01-00 172/276 AM\1207705EN.docx EN medical needs, the Programme should medical needs, the Programme should provide support to clinical trials so as to provide support to clinical trials so as to speed up the development, authorisation speed up the development, authorisation and access to innovative and effective and access to innovative, holistic and medicines, promote incentives to develop effective medicines and treatment, such medicinal products as antimicrobials promote incentives to boost the production and foster the digitial transformation of capacity for antimicrobials, personalized healthcare products and platforms for treatment and vaccination, and foster the monitoring and collecting information on digital transformation of healthcare medicines. 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 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. In 2020, the Commission announced the ‘Pharmaceutical strategy for Europe’ with the overall goal of helping to ensure the Union’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry’s innovation efforts in the Union and globally. The Programme should support the implementation of the Pharmaceutical strategy for Europe and the reduction of the medication-related burden.

Or. en

Amendment 339 Sirpa Pietikäinen

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor shortages of medicines, medical devices and other medicines, medical devices and other healthcare products and to ensure greater healthcare products and to ensure greater

AM\1207705EN.docx 173/276 PE653.822v01-00 EN availability and affordability of those availability and affordability of those products while limiting the dependency of products while limiting the dependency of their supply chains on third countries. In their supply chains on third countries. In particular, in order to address unmet particular, in order to address unmet medical needs, the Programme should medical needs, the Programme should provide support to clinical trials so as to provide support to clinical trials so as to speed up the development, authorisation speed up the development, authorisation and access to innovative and effective and access to innovative and effective medicines, promote incentives to develop medicines and treatment, promote such medicinal products as antimicrobials incentives to boost the production capacity and foster the digitial transformation of for antimicrobials, personalized medicines healthcare products and platforms for and care, treatment and vaccination, and monitoring and collecting information on foster the digital transformation of health medicines. care 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 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 health care systems and clinical practice. In 2020, the Commission announced the ‘Pharmaceutical strategy for Europe’ with the overall goal of helping to ensure the Union’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry’s innovation efforts in the Union and globally. The Programme should support the implementation of the Pharmaceutical strategy for Europe.

Or. en

Amendment 340 Joanna Kopcińska

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor, prevent and

PE653.822v01-00 174/276 AM\1207705EN.docx EN medicines, medical devices and other manage shortages of medicines, medical healthcare products and to ensure greater devices and other healthcare products and availability and affordability of those to ensure greater availability and products while limiting the dependency of affordability of those products while their supply chains on third countries. In limiting the dependency of their supply particular, in order to address unmet chains on third countries. In particular, in medical needs, the Programme should order to address unmet medical needs, the provide support to clinical trials so as to Programme should provide support to speed up the development, authorisation clinical trials so as to speed up the and access to innovative and effective development, authorisation and access to medicines, promote incentives to develop innovative and effective medicines and such medicinal products as antimicrobials treatment, promote incentives to boost the and foster the digitial transformation of production capacity for antimicrobials, healthcare products and platforms for personalised treatment and vaccination, monitoring and collecting information on and foster the digital transformation of medicines. healthcare products and platforms for monitoring and collecting information on medicines. The Programme should also help to ensure best use of research results and facilitate the uptake, scaling-up and deployment of clinical practice. In 2020, the Commission announced the ‘Pharmaceutical strategy for Europe’ with the overall goal of helping to ensure the Union’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry’s innovation efforts in the Union and globally. The Programme should offer some support to the implementation of the Pharmaceutical strategy for Europe.

Or. en

Amendment 341 Sara Cerdas, Tudor Ciuhodaru, Rovana Plumb, Milan Brglez, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor shortages of medicines, medical devices and other medicines, medical devices and other

AM\1207705EN.docx 175/276 PE653.822v01-00 EN healthcare products and to ensure greater healthcare products and to ensure greater availability and affordability of those availability and affordability of those products while limiting the dependency of products while limiting the dependency of their supply chains on third countries. In their supply chains on third countries. In particular, in order to address unmet particular, in order to address unmet medical needs, the Programme should medical needs, the Programme should provide support to clinical trials so as to provide support to clinical trials so as to speed up the development, authorisation speed up the development, authorisation and access to innovative and effective and access to innovative and effective medicines, promote incentives to develop medicines and medical devices, promote such medicinal products as antimicrobials research and the development of new and foster the digitial transformation of medical products, with particular healthcare products and platforms for attention to antimicrobials and vaccines to monitoring and collecting information on tackle AMR and vaccine-preventable medicines. diseases, boost the production of essential medicines and the active pharmaceutical ingredient (API), develop such medicinal products as transformation of healthcare products and platforms for monitoring and collecting information on patients health, increasing self-management of their health, and information about the use of healthcare services, medicines and medical devices.

Or. en

Amendment 342 Cristian-Silviu Buşoi

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should develop a support actions to monitor shortages of single pan-European monitoring, medicines, medical devices and other reporting and notification system for healthcare products and to ensure greater shortages of medicines, medical devices availability and affordability of those and other healthcare products, to avoid products while limiting the dependency of fragmentation of the single market and to their supply chains on third countries. In ensure greater availability and affordability particular, in order to address unmet of those products while limiting the medical needs, the Programme should dependency of their supply chains on third provide support to clinical trials so as to countries. In particular, in order to address speed up the development, authorisation unmet medical needs, the Programme and access to innovative and effective should provide support to clinical and real

PE653.822v01-00 176/276 AM\1207705EN.docx EN medicines, promote incentives to develop world evidence generation to enable the such medicinal products as antimicrobials development, authorisation, evaluation and and foster the digitial transformation of access to effective new medicines. the healthcare products and platforms for programme should foster the digital monitoring and collecting information on transformation of healthcare products and medicines. platforms for single pan-European monitoring and collecting information on medicines. The Programme should support the implementation of the new Pharmaceutical Strategy for Europe and the work of the EMA.

Or. en

Amendment 343 Edina Tóth

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor shortages of medicines, medical devices and other medicines, medical devices and other healthcare products and to ensure greater healthcare products and to ensure greater availability and affordability of those availability and affordability of those products while limiting the dependency of products while limiting the dependency of their supply chains on third countries. In their supply chains on third countries. In particular, in order to address unmet particular, in order to address unmet medical needs, the Programme should medical needs, the Programme should provide support to clinical trials so as to provide support to clinical trials so as to speed up the development, authorisation speed up the development, authorisation and access to innovative and effective and access to innovative and effective medicines, promote incentives to develop medicines, promote incentives to develop such medicinal products as antimicrobials such medicinal products as antimicrobials and foster the digitial transformation of and foster the digital transformation of healthcare products and platforms for healthcare products and platforms for monitoring and collecting information on monitoring and collecting information on medicines. medicines. The Program should support action against the spread of falsified medicines from unauthorised website sand vendors that are raising concerns nowadays; this practice can cause serious harm and can lead to severe health problems or worsen the health condition of citizens; EU coordination in mapping

AM\1207705EN.docx 177/276 PE653.822v01-00 EN and combatting of counterfeit of medicines is essential.

Or. en

Amendment 344 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor and respond to medicines, medical devices and other shortages of medicines, medical devices, healthcare products and to ensure greater vaccines and diagnostic tools and other availability and affordability of those healthcare products and to ensure greater products while limiting the dependency of availability and affordability of those their supply chains on third countries. In products while limiting the dependency of particular, in order to address unmet their supply chains on third countries. In medical needs, the Programme should particular, in order to address unmet provide support to clinical trials so as to medical needs, the Programme should speed up the development, authorisation provide support to clinical trials so as to and access to innovative and effective speed up the development, authorisation medicines, promote incentives to develop and access to innovative and effective such medicinal products as antimicrobials medicines, promote incentives to develop and foster the digitial transformation of such medicinal products as antimicrobials healthcare products and platforms for and foster the digital transformation of monitoring and collecting information on healthcare products and platforms for medicines. monitoring and collecting information on medicines. The full and rapid application of Regulation (EU) N° 536/ 2014 on clinical trials for medicinal products for human use should facilitate the launch of large clinical trials carried out in a harmonized and coordinated manner at European level.

Or. en

Amendment 345 Luisa Regimenti, Joëlle Mélin, Catherine Griset, Danilo Oscar Lancini, Lucia Vuolo,

PE653.822v01-00 178/276 AM\1207705EN.docx EN Silvia Sardone, Vincenzo Sofo, Marco Dreosto, Aurelia Beigneux

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor shortages of medicines, medical devices and other medicines, medical devices and other healthcare products and to ensure greater healthcare products and to ensure greater availability and affordability of those availability and affordability of those products while limiting the dependency of products while limiting the dependency of their supply chains on third countries. In their supply chains on third countries, in particular, in order to address unmet particular actions, where necessary in medical needs, the Programme should synergy with other programmes, to provide support to clinical trials so as to encourage local production of medicinal speed up the development, authorisation plants in the Member States, and to and access to innovative and effective encourage and support production of medicines, promote incentives to develop active ingredients and generics within the such medicinal products as antimicrobials European Union. In particular, in order to and foster the digitial transformation of address unmet medical needs, the healthcare products and platforms for Programme should provide support to monitoring and collecting information on clinical trials so as to speed up the medicines. development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digital transformation of healthcare products and platforms for monitoring and collecting information on medicines.

Or. it

Amendment 346 Kateřina Konečná

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor, prevent and medicines, medical devices and other manage shortages of medicines, medical healthcare products and to ensure greater devices and other healthcare products and

AM\1207705EN.docx 179/276 PE653.822v01-00 EN availability and affordability of those to ensure greater availability and products while limiting the dependency of affordability of those products while their supply chains on third countries. In limiting the dependency of their supply particular, in order to address unmet chains on third countries. In particular, in medical needs, the Programme should order to address unmet medical needs, the provide support to clinical trials so as to Programme should provide support to speed up the development, authorisation clinical trials so as to speed up the and access to innovative and effective development, authorisation and access to medicines, promote incentives to develop innovative and effective medicines, such medicinal products as antimicrobials promote incentives to develop such and foster the digitial transformation of medicinal products as antimicrobials and healthcare products and platforms for foster the digital transformation of monitoring and collecting information on healthcare products and platforms for medicines. monitoring and collecting information on medicines. The Programme should support the implementation of the new Pharmaceutical Strategy for Europe and the work of the EMA.

Or. en

Amendment 347 Maria Spyraki

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to establish and support medicines, medical devices and other the creation of a central monitoring and healthcare products and to ensure greater early notification mechanism for availability and affordability of those shortages of medicines, medical devices products while limiting the dependency of and other healthcare products and to ensure their supply chains on third countries. In greater availability and affordability of particular, in order to address unmet those products while limiting the medical needs, the Programme should dependency of their supply chains on third provide support to clinical trials so as to countries and avoid the fragmentation of speed up the development, authorisation the internal market. In particular, in order and access to innovative and effective to address unmet medical needs, the medicines, promote incentives to develop Programme should provide support to such medicinal products as antimicrobials clinical trials so as to speed up the and foster the digitial transformation of development, authorisation and access to healthcare products and platforms for innovative and effective medicines, monitoring and collecting information on promote incentives to develop such medicinal products as antimicrobials and

PE653.822v01-00 180/276 AM\1207705EN.docx EN medicines. foster the digital transformation of healthcare products and platforms for monitoring and collecting information on medicines.

Or. en

Amendment 348 Adam Jarubas

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to develop a single pan- medicines, medical devices and other European monitoring, reporting and healthcare products and to ensure greater notification system for shortages of availability and affordability of those medicines, medical devices and other products while limiting the dependency of healthcare products to avoid fragmentation their supply chains on third countries. In of the single market and to ensure greater particular, in order to address unmet availability and affordability of those medical needs, the Programme should products while limiting the dependency of provide support to clinical trials so as to their supply chains on third countries. In speed up the development, authorisation particular, in order to address unmet and access to innovative and effective medical needs, the Programme should medicines, promote incentives to develop provide support to clinical trials so as to such medicinal products as antimicrobials speed up the development, authorisation and foster the digitial transformation of and access to innovative and effective healthcare products and platforms for medicines, promote incentives to develop monitoring and collecting information on such medicinal products as antimicrobials medicines. and foster the digital transformation of healthcare products and platforms for unified pan- European monitoring and collecting information on medicines.

Or. en

Amendment 349 Danilo Oscar Lancini

Proposal for a regulation Recital 22

AM\1207705EN.docx 181/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to develop a single pan- medicines, medical devices and other European monitoring, reporting and healthcare products and to ensure greater notification system for shortages of availability and affordability of those medicines, medical devices and other products while limiting the dependency of healthcare products to avoid fragmentation their supply chains on third countries. In of the single market and to ensure greater particular, in order to address unmet availability and affordability of those medical needs, the Programme should products while limiting the dependency of provide support to clinical trials so as to their supply chains on third countries. In speed up the development, authorisation particular, in order to address unmet and access to innovative and effective medical needs, the Programme should medicines, promote incentives to develop provide support to clinical trials so as to such medicinal products as antimicrobials speed up the development, authorisation and foster the digitial transformation of and access to innovative and effective healthcare products and platforms for medicines, promote incentives to develop monitoring and collecting information on such medicinal products as antimicrobials medicines. and foster the digital transformation of healthcare products and platforms for monitoring and collecting information on medicines.

Or. en

Amendment 350 Nathalie Colin-Oesterlé

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to develop a pan-European medicines, medical devices and other monitoring, reporting and notification healthcare products and to ensure greater system to monitor shortages of medicines, availability and affordability of those medical devices and other healthcare products while limiting the dependency of products to strengthen the Single Market, their supply chains on third countries. In and to ensure greater availability and particular, in order to address unmet affordability of those products while medical needs, the Programme should limiting the dependency of their supply provide support to clinical trials so as to chains on third countries. In particular, in speed up the development, authorisation order to address unmet medical needs, the and access to innovative and effective Programme should provide support to

PE653.822v01-00 182/276 AM\1207705EN.docx EN medicines, promote incentives to develop clinical trials so as to speed up the such medicinal products as antimicrobials development, authorisation and access to and foster the digitial transformation of innovative and effective medicines, healthcare products and platforms for promote incentives to develop such monitoring and collecting information on medicinal products as antimicrobials and medicines. foster the digital transformation of healthcare products and platforms for monitoring and collecting information on medicines.

Or. fr

Amendment 351 César Luena

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to develop an European medicines, medical devices and other monitoring, reporting and notification healthcare products and to ensure greater system for shortages of medicines, medical availability and affordability of those devices and other healthcare products to products while limiting the dependency of avoid fragmentation of the single market their supply chains on third countries. In and to ensure greater availability and particular, in order to address unmet affordability of those products while medical needs, the Programme should limiting the dependency of their supply provide support to clinical trials so as to chains on third countries. In particular, in speed up the development, authorisation order to address unmet medical needs, the and access to innovative and effective Programme should provide support to medicines, promote incentives to develop clinical trials so as to speed up the such medicinal products as antimicrobials development, authorisation and access to and foster the digitial transformation of innovative and effective medicines, healthcare products and platforms for promote incentives to develop such monitoring and collecting information on medicinal products as antimicrobials and medicines. foster the digital transformation of healthcare products and platforms for monitoring and collecting information on medicines.

Or. en

AM\1207705EN.docx 183/276 PE653.822v01-00 EN Amendment 352 Jessica Polfjärd

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor shortages of medicines, medical devices and other medicines, medical devices and other healthcare products and to ensure greater healthcare products and to ensure greater availability and affordability of those availability, accessibility and affordability products while limiting the dependency of of those products while limiting the their supply chains on third countries. In dependency of their supply chains on a particular, in order to address unmet small number of manufacturers and medical needs, the Programme should evaluating the Union's dependency on provide support to clinical trials so as to third countries. In particular, in order to speed up the development, authorisation address unmet medical needs, the and access to innovative and effective Programme should provide support to medicines, promote incentives to develop clinical trials so as to speed up the such medicinal products as antimicrobials development, authorisation and access to and foster the digitial transformation of innovative and effective medicines, healthcare products and platforms for promote incentives to develop such monitoring and collecting information on medicinal products as antimicrobials and medicines. foster the digital transformation of healthcare products and platforms for monitoring and collecting information on medicines.

Or. en

Amendment 353 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to address the root causes medicines, medical devices and other of the shortages of medicines, medical healthcare products and to ensure greater devices and other healthcare products, to availability and affordability of those monitor shortages in Member States and products while limiting the dependency of at Union's level and to ensure greater their supply chains on third countries. In availability and affordability of those

PE653.822v01-00 184/276 AM\1207705EN.docx EN particular, in order to address unmet products while limiting the dependency of medical needs, the Programme should their supply chains on third countries. In provide support to clinical trials so as to particular, in order to address unmet speed up the development, authorisation medical needs, the Programme should and access to innovative and effective provide support to clinical trials so as to medicines, promote incentives to develop speed up the development, authorisation such medicinal products as antimicrobials and access to innovative and effective and foster the digitial transformation of medicines, promote incentives to develop healthcare products and platforms for such medicinal products as antimicrobials monitoring and collecting information on and foster the digital transformation of medicines. healthcare products and platforms for monitoring and collecting information on medicines.

Or. en

Amendment 354 Mairead McGuinness

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor and prevent medicines, medical devices and other shortages of medicines, medical devices healthcare products and to ensure greater and other healthcare products and to ensure availability and affordability of those greater availability and affordability of products while limiting the dependency of those products while limiting the their supply chains on third countries. In dependency of their supply chains on a particular, in order to address unmet single source. In particular, in order to medical needs, the Programme should address unmet medical needs, the provide support to clinical trials so as to Programme should provide support to speed up the development, authorisation clinical trials so as to speed up the and access to innovative and effective development, authorisation and access to medicines, promote incentives to develop innovative and effective medicines, such medicinal products as antimicrobials promote incentives to develop such and foster the digitial transformation of medicinal products as antimicrobials and healthcare products and platforms for foster the digital transformation of monitoring and collecting information on healthcare products and platforms for medicines. monitoring and collecting information on medicines.

Or. en

AM\1207705EN.docx 185/276 PE653.822v01-00 EN Amendment 355 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 22

Text proposed by the Commission Amendment

(22) The Programme should therefore (22) The Programme should therefore support actions to monitor shortages of support actions to monitor and to prevent medicines, medical devices and other shortages of medicines, medical devices healthcare products and to ensure greater and other healthcare products and to ensure availability and affordability of those greater availability and affordability of products while limiting the dependency of those products while limiting the their supply chains on third countries. In dependency of their supply chains on third particular, in order to address unmet countries. In particular, in order to address medical needs, the Programme should unmet medical needs, the Programme provide support to clinical trials so as to should provide support to clinical trials so speed up the development, authorisation as to speed up the development, and access to innovative and effective authorisation and access to innovative and medicines, promote incentives to develop effective medicines, promote incentives to such medicinal products as antimicrobials develop such medicinal products as and foster the digitial transformation of antimicrobials and foster the digital healthcare products and platforms for transformation of healthcare products and monitoring and collecting information on platforms for monitoring and collecting medicines. information on medicines.

Or. en

Amendment 356 Michèle Rivasi

Proposal for a regulation Recital 22 a (new)

Text proposed by the Commission Amendment

(22a) Resolution WHA 67.18 of the World Health Assembly urges parties to 1) adapt, adopt and implement, where appropriate, the WHO Traditional Medicine Strategy 2014 – 2023, as a basis for national traditional and complementary medicine programmes or work plans; and to 2) develop and implement working plans to integrate traditional and complementary medicine

PE653.822v01-00 186/276 AM\1207705EN.docx EN into health services, particularly primary health care services. The WHO Traditional Medicine Strategy 2014 – 2023 aims to support Member States in developing policies and implementing action plans to promote health with the support of traditional, complementary and integrative medicine.

Or. en

Amendment 357 Cristian-Silviu Buşoi

Proposal for a regulation Recital 22 a (new)

Text proposed by the Commission Amendment

(22a) Support actions to ensure the implementation of cross-cutting EU policy initiatives aimed at building a sustainable Europe with a high level of human health protection, such as the European Green Deal and its component strategies.

Or. en

Amendment 358 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 22 a (new)

Text proposed by the Commission Amendment

(22a) In its Pharmaceutical Strategy, the Commission should introduce the revision of the orphan and paediatric legislation and of the Directive 2001/83/EC establishing a Community code relating to medicinal products for human use.

AM\1207705EN.docx 187/276 PE653.822v01-00 EN Or. en

Amendment 359 Michèle Rivasi

Proposal for a regulation Recital 22 b (new)

Text proposed by the Commission Amendment

(22b) To expand access to health technologies, the Programme should support actions that contribute to the implementation of the 2019 Resolution by the World Health Assembly on improving the transparency of markets for medicines, vaccines and other health products.

Or. en

Amendment 360 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 22 b (new)

Text proposed by the Commission Amendment

(22b) To ensure effective controls and full transparency of the procedures used to determine the prices of medicines, the Commission should propose a revision of Directive 89/105/EEC on the transparency of measures regulating the price of medicinal products.

Or. en

Amendment 361 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie

PE653.822v01-00 188/276 AM\1207705EN.docx EN Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 22 c (new)

Text proposed by the Commission Amendment

(22c) To reduce its dependence on third countries for certain biological and medicinal products such as blood and plasma derived medicinal products, the Union should increase its capacity to collect and stockpile blood and plasma. To avoid the risk of shortages on those products, the Union should rapidly revise the Blood, Tissues and Cells legislations, Directive 2002/98/EC and Directive 2004/23/EC.

Or. en

Amendment 362 Joanna Kopcińska

Proposal for a regulation Recital 23

Text proposed by the Commission Amendment

(23) As the optimal use of medicines (23) As the optimal use of medicines and antimicrobials in particular yields and antimicrobials in particular yields benefits for individuals and health systems, benefits for individuals and health systems, the Programme should promote their the Programme should promote their prudent and efficient use. In line with the prudent and efficient use. In line with the European One Health Action Plan against European One Health Action Plan against Antimicrobial Resistance14 , adopted in Antimicrobial Resistance14 , adopted in June 2017 following the request from June 2017 following the request from Member States, and given the experience Member States, and given that infections with the bacterial secondary infections caused by antibiotic-resistant bacteria related to COVID 19, it is essential that the were responsible for 33,110 deaths in the Programme supports actions aimed at the European Union and European prudent use of antimicrobials in humans, Economic Area in 2015, according to data animals and crops, in the framework of an from the European Center for Disease integrated policy on patient safety and Control, as well as the experience with the prevention of medical errors. bacterial secondary infections related to COVID 19, it is essential that the

AM\1207705EN.docx 189/276 PE653.822v01-00 EN Programme supports actions aimed at the prudent use of antimicrobials in humans, animals and crops, in the framework of an integrated policy on patient safety and prevention of medical errors. Notes moreover that the spread of Antimicrobial Resistance will require a greater emphasis in the Programme on preventing infections due to Gram-negative bacteria because there are relatively few existing treatment options for them and a limited number of new antibiotics in development. ______14 Communication from the Commission to 14 Communication from the Commission to the Council and the European Parliament the Council and the European Parliament ‘A European One Health Action Plan ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017. COM(2017)0339 final of 29.6.2017.

Or. en

Amendment 363 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 23

Text proposed by the Commission Amendment

(23) As the optimal use of medicines (23) As the optimal use of medicines and antimicrobials in particular yields and antimicrobials in particular yields benefits for individuals and health systems, benefits for individuals and health systems, the Programme should promote their the Programme should promote their prudent and efficient use. In line with the prudent and efficient use. In line with the European One Health Action Plan against European One Health Action Plan against Antimicrobial Resistance14 , adopted in Antimicrobial Resistance14, adopted in June 2017 following the request from June 2017 following the request from Member States, and given the experience Member States, and given the experience with the bacterial secondary infections with the bacterial secondary infections related to COVID 19, it is essential that the related to COVID 19, it is essential that the Programme supports actions aimed at the Programme supports actions aimed at the prudent use of antimicrobials in humans, prudent use of antimicrobials in humans, animals and crops, in the framework of an animals and crops, in the framework of an

PE653.822v01-00 190/276 AM\1207705EN.docx EN integrated policy on patient safety and integrated policy on patient safety and prevention of medical errors. prevention of medical errors. The Programme should support the ECDC monitoring and surveillance programmes concerning 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. ______14 Communication from the Commission to 14 Communication from the Commission to the Council and the European Parliament the Council and the European Parliament ‘A European One Health Action Plan ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017. COM(2017)0339 final of 29.6.2017.

Or. en

Amendment 364 Sirpa Pietikäinen

Proposal for a regulation Recital 23

Text proposed by the Commission Amendment

(23) As the optimal use of medicines (23) As the optimal use of medicines and antimicrobials in particular yields and antimicrobials in particular yields benefits for individuals and health systems, benefits for individuals and health systems, the Programme should promote their the Programme should promote their prudent and efficient use. In line with the prudent and efficient use. In line with the European One Health Action Plan against European One Health Action Plan against Antimicrobial Resistance14 , adopted in Antimicrobial Resistance14 , adopted in June 2017 following the request from June 2017 following the request from Member States, and given the experience Member States, and given the experience with the bacterial secondary infections with the bacterial secondary infections related to COVID 19, it is essential that the related to COVID 19, it is essential that the Programme supports actions aimed at the Programme supports actions aimed at the prudent use of antimicrobials in humans, prudent use of antimicrobials in humans, animals and crops, in the framework of an animals and crops, in the framework of an integrated policy on patient safety and integrated policy on patient safety and prevention of medical errors. prevention of medical errors. Regulation (EU) 2019/6 on veterinary medicinal products should be reviewed in this regard

AM\1207705EN.docx 191/276 PE653.822v01-00 EN to use antibiotic medicinal products and other medication only for treatment of disease prescribed by a veterinary for a limited period of time and not to be used for prophylaxis. ______14 Communication from the Commission to 14 Communication from the Commission to the Council and the European Parliament the Council and the European Parliament ‘A European One Health Action Plan ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017. COM(2017)0339 final of 29.6.2017.

Or. en

Amendment 365 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 23

Text proposed by the Commission Amendment

(23) As the optimal use of medicines (23) As the optimal use of medicines and antimicrobials in particular yields and antimicrobials in particular yields benefits for individuals and health systems, benefits for individuals and health systems, the Programme should promote their the Programme should promote their prudent and efficient use. In line with the prudent and efficient use. In line with the European One Health Action Plan against European One Health Action Plan against Antimicrobial Resistance14 , adopted in Antimicrobial Resistance14 , adopted in June 2017 following the request from June 2017 following the request from Member States, and given the experience Member States, and given the experience with the bacterial secondary infections with the bacterial secondary infections related to COVID 19, it is essential that the related to COVID 19, it is essential that the Programme supports actions aimed at the Programme supports actions aimed at the prudent use of antimicrobials in humans, prudent use of antimicrobials in humans, animals and crops, in the framework of an animals and crops, in the framework of an integrated policy on patient safety and integrated policy on patient safety and prevention of medical errors. prevention of medical errors. TheEU4health programme funding should be based on actions that are traceable, setting Union-wide reduction targets for antibiotics and medicine use, and support the research and development of new antibiotics ______

PE653.822v01-00 192/276 AM\1207705EN.docx EN 14 Communication from the Commission to 14 Communication from the Commission to the Council and the European Parliament the Council and the European Parliament ‘A European One Health Action Plan ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017. COM(2017)0339 final of 29.6.2017.

Or. en

Amendment 366 Michèle Rivasi

Proposal for a regulation Recital 23

Text proposed by the Commission Amendment

(23) As the optimal use of medicines (23) As the optimal use of medicines and antimicrobials in particular yields and antimicrobials in particular yields benefits for individuals and health systems, benefits for individuals and health systems, the Programme should promote their the Programme should promote their prudent and efficient use. In line with the prudent and efficient use. In line with the European One Health Action Plan against European One Health Action Plan against Antimicrobial Resistance14 , adopted in Antimicrobial Resistance14,adopted in June June 2017 following the request from 2017 following the request from Member Member States, and given the experience States, and given the experience with the with the bacterial secondary infections bacterial secondary infections related to related to COVID 19, it is essential that the COVID 19, it is essential that the Programme supports actions aimed at the Programme supports actions aimed at the prudent use of antimicrobials in humans, prudent use of antimicrobials in humans, animals and crops, in the framework of an animals and crops, and actions including integrated policy on patient safety and the use of non-antibiotic integrative prevention of medical errors. treatments, in the framework of an integrated and integrative policy on patient safety and prevention of medical errors.. ______14 Communication from the Commission to 14 Communication from the Commission to the Council and the European Parliament the Council and the European Parliament ‘A European One Health Action Plan ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017. COM(2017)0339 final of 29.6.2017.

Or. en

AM\1207705EN.docx 193/276 PE653.822v01-00 EN Amendment 367 Kateřina Konečná

Proposal for a regulation Recital 23 a (new)

Text proposed by the Commission Amendment

(23a) Health associated infections (‘HAI’) are infections that patients get while receiving healthcare for another condition. The ECDC has estimated that, on average, healthcare associated infections occur in one hospitalised patient in 20, that is to say 4,1 million patients a year in the Union, and that 37 000 deaths are caused every year as a result of such infections. Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. HAI can happen in any healthcare facility, including hospitals, ambulatory surgical centres, end-stage renal disease facilities, and long-term care facilities It is therefore important that the Commission, under the Programme, develops guidelines for preventing HAI, and that the Programme supports investment in modernizing health systems to overcome and reduce HAI and supports interventions to improve patient safety, including the implementation of Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections. European-level collaboration and coordination on patient safety should be enhanced through the creation of a European Network on Patient Safety, supported through the Health Programme and with direct involvement of patients’ organisations.

Or. en

PE653.822v01-00 194/276 AM\1207705EN.docx EN Amendment 368 Cristian-Silviu Buşoi

Proposal for a regulation Recital 23 a (new)

Text proposed by the Commission Amendment

(23a) HAI are infections that patients get while receiving healthcare for another condition. The ECDC has estimated that, on average, health care associated infections occur in one hospitalised patient in 20, that is to say 4,1million patients a year in the Union, and that 37 000 deaths are caused every year as a result of such infections. Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. HAI can happen in any healthcare facility, including hospitals, ambulatory surgical centres, end-stage renal disease facilities, and long-term care facilities It is therefore important that the Commission, under the Programme, develops guidelines for preventing HAI, and that the Programme supports investment in modernizing health systems to overcome and reduce HAI and supports interventions to improve patient safety, including the implementation of Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections. European-level collaboration and coordination on patient safety should be enhanced through the creation of a European Network on Patient Safety, supported through the Health Programme and with direct involvement of patients’ organisations.

Or. en

Amendment 369 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López,

AM\1207705EN.docx 195/276 PE653.822v01-00 EN Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 23 a (new)

Text proposed by the Commission Amendment

(23a) HAI are infections that patients get while receiving healthcare for another condition or infections suffered by inhabitants of long-term residences. The ECDC has estimated that, on average, healthcare associated infections occur in one hospitalised patient in 20, that is to say 4,1 million patients a year in the Union, and that 37 000 deaths are caused every year as a result of such infections. Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. HAI can happen in any healthcare facility, including hospitals, ambulatory surgical centres, end-stage renal disease facilities, and long-term care facilities It is therefore important that the Commission, under the Programme, develops guidelines for preventing HAI, and that the Programme supports investment in modernizing health systems to overcome and reduce HAI and supports interventions to improve patient safety, including the implementation of the Council's Recommendation of 9 June 2009 on patient safety, including the prevention and control of HAI 1a.

Or. en

Amendment 370 Joanna Kopcińska

Proposal for a regulation Recital 23 a (new)

PE653.822v01-00 196/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(23a) Effective international collaboration is key to controlling HAIs and Antimicrobial Resistance and the EU has an important role in supporting Member States in this area, for example through research programmes, the surveillance systems operated by the ECDC and the development of EU wide point prevalence survey methodology.

Or. en

Amendment 371 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 23 a (new)

Text proposed by the Commission Amendment

(23a) According to WHO, 12.6 million people died as a result of living or working in an unhealthy environment in2012 – nearly 1 in 4 of total global deaths. Environmental pollution factors, such as air, water and soil pollution, chemical exposures, climate change, and ultraviolet radiation, contribute to more than 100 diseases and injuries.

Or. en

Amendment 372 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 23 b (new)

AM\1207705EN.docx 197/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(23b) The Programme should promote and guarantee via its actions the environmental health of European citizens in the framework of the European Green Deal. The Union should adopt the WHO definition which describes environmental health as the inclusion of “ aspects of human health, such as the quality of life, which are determined by the physical, chemical, biological, social, psychosocial and aesthetic factors of our environment. It also concerns the policy and practices for the prevention, management and control of environmental factors likely to affect the health of present and future generations”.

Or. en

Amendment 373 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Recital 24

Text proposed by the Commission Amendment

(24) Since environmental pollution (24) Since environmental pollution caused by human and veterinary caused by human and veterinary pharmaceutical substances is an emerging pharmaceutical substances is an emerging environmental problem that can impact on environmental problem that can impact on public health, the Programme should foster public health, the Programme should foster measures to strengthen the assessment and measures to strengthen the assessment and appropriate management of environmental appropriate management of environmental risks associated with the production, use risks associated with the production, use and disposal of medicinal products, in line and disposal of medicinal products, in line with the European Union Strategic with the European Union Strategic Approach to Pharmaceuticals in the Approach to Pharmaceuticals in the Environment15 . Environment15. The Programme will reinforce the need to have health impact assessments in the EU policies and should promote health promotion and protection

PE653.822v01-00 198/276 AM\1207705EN.docx EN in all EU policies, taking into account the European Green Deal, The Farm to Fork Strategy, The Biodiversity Strategy and the Pharmaceutical Strategy for Europe and others. ______15 Communication of the Commission to 15 Communication of the Commission to the European Parliament, the Council and the European Parliament, the Council and the European economic and Social the European economic and Social Committee ‘European Union Strategic Committee ‘European Union Strategic Approach to Pharmaceuticals in the Approach to Pharmaceuticals in the Environment’, COM(2019)128 final of Environment’, COM(2019)128 final of 11.03.2019. 11.03.2019.

Or. en

Amendment 374 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 24

Text proposed by the Commission Amendment

(24) Since environmental pollution (24) Since the pollution caused by caused by human and veterinary human and veterinary pharmaceutical pharmaceutical substances is an emerging substances is an emerging environmental environmental problem that can impact on problem that can impact on public health, public health, the Programme should foster the Programme should foster measures to measures to strengthen the assessment and strengthen the assessment and appropriate appropriate management of environmental management of environmental risks risks associated with the production, use associated with the production, use and and disposal of medicinal products, in line disposal of medicinal products, in line with with the European Union Strategic the European Union Strategic Approach to Approach to Pharmaceuticals in the Pharmaceuticals in the Environment15 . Environment15 . ______15 Communication of the Commission to 15 Communication of the Commission to the European Parliament, the Council and the European Parliament, the Council and the European economic and Social the European economic and Social Committee ‘European Union Strategic Committee ‘European Union Strategic Approach to Pharmaceuticals in the Approach to Pharmaceuticals in the Environment’, COM(2019)128 final of Environment’, COM(2019)128 final of

AM\1207705EN.docx 199/276 PE653.822v01-00 EN 11.03.2019. 11.03.2019.

Or. en

Amendment 375 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 25

Text proposed by the Commission Amendment

(25) The Union health legislation has an (25) The Union health legislation has an immediate impact on public health, the immediate impact on public health, the lives of citizens, the efficiency and lives of citizens, the efficiency and resilience of the health systems and the resilience of the health systems and the good functioning of the internal market. good functioning of the internal market. The regulatory framework for medical The regulatory framework for the products and technologies (medicinal recognition of professional qualifications, products, medical devices and substances medical products and technologies of human origin), as well as for tobacco (medicinal products, medical devices and legislation, patients’ rights in cross-border substances of human origin), as well as for healthcare and serious cross-border threats tobacco legislation, patients’ rights in to health is essential to health protection in cross-border healthcare and serious cross- the Union. The Programme therefore border threats to health is essential to should support the development, health protection in the Union. The implementation and enforcement of Union Programme therefore should support the health legislation and provide high quality, development, implementation and comparable and reliable data to underpin enforcement of Union health legislation policymaking and monitoring. and provide high quality, unbiased, comparable and reliable data to underpin policymaking and monitoring. Union health legislation needs to be based on current scientific evidence-based data, that should be collected locally across Europe, through a well-defined homogeneous methodology. The legislation and its implementation and consequences should be evaluated and reported, resulting in a cycle of quality improvement of health in the Union.

Or. en

PE653.822v01-00 200/276 AM\1207705EN.docx EN Amendment 376 Joanna Kopcińska

Proposal for a regulation Recital 25

Text proposed by the Commission Amendment

(25) The Union health legislation has an (25) The Union health legislation has an immediate impact on public health, the immediate impact on public health, the lives of citizens, the efficiency and lives of citizens, the efficiency and resilience of the health systems and the resilience of the health systems and the good functioning of the internal market. good functioning of the internal market. The regulatory framework for medical The regulatory framework for medical products and technologies (medicinal products and technologies (medicinal products, medical devices and substances products, medical devices and substances of human origin), as well as for tobacco of human origin), as well as for tobacco legislation, patients’ rights in cross-border legislation, patients’ rights in cross-border healthcare and serious cross-border threats healthcare and serious cross-border threats to health is essential to health protection in to health is essential to health protection in the Union. The Programme therefore the Union. The Programme therefore should support the development, should support the development, implementation and enforcement of Union implementation and enforcement of Union health legislation and provide high quality, health legislation and, working in comparable and reliable data to underpin conjunction with key partners such as the policymaking and monitoring. EMA and the ECDC, provide high quality, comparable and reliable data to underpin policymaking and monitoring.

Or. en

Amendment 377 Cristian-Silviu Buşoi

Proposal for a regulation Recital 25

Text proposed by the Commission Amendment

(25) The Union health legislation has an (25) The Union health legislation has an immediate impact on public health, the immediate impact on public health, the lives of citizens, the efficiency and lives of citizens, the efficiency and resilience of the health systems and the resilience of the health systems and the good functioning of the internal market. good functioning of the internal market. The regulatory framework for medical The regulatory framework for medical products and technologies (medicinal products and technologies (medicinal products, medical devices and substances products, medical devices and substances

AM\1207705EN.docx 201/276 PE653.822v01-00 EN of human origin), as well as for tobacco of human origin), as well as for tobacco legislation, patients’ rights in cross-border legislation, patients’ rights in cross-border healthcare and serious cross-border threats healthcare and serious cross-border threats to health is essential to health protection in to health is essential to health protection in the Union. The Programme therefore the Union. The Programme therefore should support the development, should support the development, implementation and enforcement of Union implementation and enforcement of Union health legislation and provide high quality, health legislation and provide high quality, comparable and reliable data to underpin unbiased, comparable and reliable data, policymaking and monitoring. including real-world health care data, to underpin policymaking and monitoring, set targets and develop tools to measure progress (e.g. a Cancer Dashboard).

Or. en

Amendment 378 Christian Ehler on behalf of the EPP Group Dan Nica on behalf of the S&D Group Martina Dlabajová on behalf of the Renew Group Ville Niinistö on behalf of the Greens/EFA Group Cristian-Silviu Buşoi

Proposal for a regulation Recital 25

Text proposed by the Commission Amendment

(25) The Union health legislation has an (25) The Union health legislation has an immediate impact on public health, the immediate impact on public health, the lives of citizens, the efficiency and lives of citizens, the efficiency and resilience of the health systems and the resilience of the health systems and the good functioning of the internal market. good functioning of the internal market. The regulatory framework for medical The regulatory framework for medical products and technologies (medicinal products and technologies (medicinal products, medical devices and substances products, medical devices and substances of human origin), as well as for tobacco of human origin), as well as for tobacco legislation, patients’ rights in cross-border legislation, patients’ rights in cross-border healthcare and serious cross-border threats healthcare and serious cross-border threats to health is essential to health protection in to health is essential to health protection in the Union. The Programme therefore the Union. The Programme therefore should support the development, should support the development, implementation and enforcement of Union implementation and enforcement of Union

PE653.822v01-00 202/276 AM\1207705EN.docx EN health legislation and provide high quality, health legislation and provide high quality, comparable and reliable data to underpin comparable and reliable data, including policymaking and monitoring. real-world healthcare data, thereby contributing to the development of the European health data space, to underpin policymaking and monitoring.

Or. en

Amendment 379 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 25

Text proposed by the Commission Amendment

(25) The Union health legislation has an (25) The Union health legislation has an immediate impact on public health, the immediate impact on public health and lives of citizens, the efficiency and safety, the lives of citizens, the efficiency resilience of the health systems and the and resilience of the health systems and the good functioning of the internal market. good functioning of the internal market. The regulatory framework for medical The regulatory framework for medical products and technologies (medicinal products and technologies (medicinal products, medical devices and substances products, medical devices and substances of human origin), as well as for tobacco of human origin), as well as for tobacco legislation, patients’ rights in cross-border legislation, patients’ rights in cross-border healthcare and serious cross-border threats healthcare and serious cross-border threats to health is essential to health protection in to health is essential to health protection in the Union. The Programme therefore the Union. The Programme therefore should support the development, should support the development, implementation and enforcement of Union implementation, enforcement and health legislation and provide high quality, improvement of Union health legislation, comparable and reliable data to underpin adopt early and long-term evaluation policymaking and monitoring. criteria in order to assess its implementation and provide high quality, comparable and reliable data to underpin policymaking and monitoring.

Or. en

Amendment 380 Kateřina Konečná

AM\1207705EN.docx 203/276 PE653.822v01-00 EN Proposal for a regulation Recital 25

Text proposed by the Commission Amendment

(25) The Union health legislation has an (25) The Union health legislation has an immediate impact on public health, the immediate impact on public health, the lives of citizens, the efficiency and lives of citizens, the efficiency and resilience of the health systems and the resilience of the health systems and the good functioning of the internal market. good functioning of the internal market. The regulatory framework for medical The regulatory framework for medical products and technologies (medicinal products and technologies (medicinal products, medical devices and substances products, medical devices and substances of human origin), as well as for tobacco of human origin), as well as for tobacco legislation, patients’ rights in cross-border legislation, patients’ rights in cross-border healthcare and serious cross-border threats healthcare and serious cross-border threats to health is essential to health protection in to health is essential to health protection in the Union. The Programme therefore the Union. The Programme therefore should support the development, should support the development, implementation and enforcement of Union implementation and enforcement of Union health legislation and provide high quality, health legislation and provide high quality, comparable and reliable data to underpin unbiased, comparable and reliable data, policymaking and monitoring. including real-world healthcare data, to underpin policy making and monitoring.

Or. en

Amendment 381 Antoni Comín i Oliveres

Proposal for a regulation Recital 25 a (new)

Text proposed by the Commission Amendment

(25a) The COVID-19 crisis has confirmed the perspective according to which it is convenient to strengthen the participation of the public sector in health research strategies to avoid that these are limited by strictly commercial criteria. In line with Horizon Europe, the EU4Health programme needs to help strengthen the resources necessary so that all strategic health research that cannot be done

PE653.822v01-00 204/276 AM\1207705EN.docx EN without public support may be carried out.

Or. en

Amendment 382 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Recital 25 a (new)

Text proposed by the Commission Amendment

(25a) The Union environmental legislation has an indirect, albeit important impact on public health and the resilience of national health systems. A strong and well-functioning EU environmental regulatory framework is essential to health protection. The Programme therefore should support the development, implementation and enforcement of Union environmental legislation towards a non-toxic environment.

Or. en

Amendment 383 Sirpa Pietikäinen

Proposal for a regulation Recital 26

Text proposed by the Commission Amendment

(26) Cross-border cooperation in the (26) Cross-border cooperation in the provision of healthcare to patients moving provision of healthcare to patients moving between Member States, collaboration on between Member States, collaboration on health technology assessments (HTA), and health technology assessments (HTA), and European Reference Networks (ERNs) are European Reference Networks (ERNs) are examples of areas where integrated work examples of areas where integrated work among Member States has shown to have among Member States has shown to have strong added value and great potential to strong added value and great potential to increase the efficiency of health systems increase the efficiency of health systems and thus health in general. The Programme and thus health in general. Those are

AM\1207705EN.docx 205/276 PE653.822v01-00 EN should therefore support activities to examples of areas where integrated work enable such integrated and coordinated among Member States has already been work, which also serves to foster the shown to have strong added-value and implementation of high-impact practices great potential to increase the efficiency that are aimed at distributing in the most of health systems and thus of health in effective way the available resources to the general. Nevertheless, those areas are not concerned population and areas so as to yet developed, not in terms of Union maximise their impact. legislation, nor its implementation or resources. The Programme should therefore aim at ensuring that such integrated and coordinated work is developed and implemented to its full potential in areas such as HTA and ERN. 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 sector of the population and areas so as to maximise their impact, reducing inequalities, through the consideration of sex, gender and age and the establishing of a Reference Network for safe use of medicines in pregnancy and lactation.

Or. en

Amendment 384 Pascal Arimont, Cindy Franssen, Esther de Lange

Proposal for a regulation Recital 26

Text proposed by the Commission Amendment

(26) Cross-border cooperation in the (26) Cross-border cooperation in the provision of healthcare to patients moving provision of healthcare to patients moving between Member States, collaboration on between Member States or living in border health technology assessments (HTA), and regions, collaboration on health technology European Reference Networks (ERNs) are assessments (HTA), and European examples of areas where integrated work Reference Networks (ERNs) are examples among Member States has shown to have of areas where integrated work among strong added value and great potential to Member States has shown to have strong increase the efficiency of health systems added value and great potential to increase and thus health in general. The Programme the efficiency of health systems and thus should therefore support activities to health in general. The Programme should enable such integrated and coordinated therefore support activities to enable such work, which also serves to foster the integrated and coordinated work, which

PE653.822v01-00 206/276 AM\1207705EN.docx EN implementation of high-impact practices also serves to foster the implementation of that are aimed at distributing in the most high-impact practices that are aimed at effective way the available resources to the distributing in the most effective way the concerned population and areas so as to available resources to the concerned maximise their impact. population and areas so as to maximise their impact.

Or. en

Amendment 385 Joanna Kopcińska

Proposal for a regulation Recital 26 a (new)

Text proposed by the Commission Amendment

(26a) Cross-border cooperation in the provision of healthcare to patients moving between Member States, as provided for under Directive 2011/24/EU, includes European Reference Networks (‘ERN’). This is an example where integrated work among Member States has been shown to have strong added value and great potential to increase the efficiency of health systems and therefore health in general. However, it is still to be fully elaborated in terms of Union legislation, implementation and resources. The Programme should therefore aim at ensuring that such integrated and coordinated work is developed and implemented to its full potential in areas such as ERN. That work would serve to foster the implementation of high-impact practices aimed at distributing, in the most effective way, available resources to the relevant population so as to maximise their impact.

Or. en

Amendment 386 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López,

AM\1207705EN.docx 207/276 PE653.822v01-00 EN Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 26 a (new)

Text proposed by the Commission Amendment

(26a) Solidarity and unity are principles of the Union and the programme should ensure that the Union has a coherent approach to combating cross-border health-threats. Under Article 168 TFEU, the Programme should support the creation of a European Health Response Mechanism, ready to respond to public health threats, coordinated by the ECDC and led by the Commissioner for Health and the Commissioner for Crisis Management, fully articulated with the other EU health agencies. This Mechanism with its own medical resources under a strengthened Union Civil Protection Mechanism will be prepared with a pandemic emergency plan, in order to have a coordinated response and the capacity to rapidly scale up the response to future health crises, based on standardised information.

Or. en

Amendment 387 Nathalie Colin-Oesterlé

Proposal for a regulation Recital 26 a (new)

Text proposed by the Commission Amendment

(26a) The mobility of cross-border medical workers should be guaranteed in order to ensure the continuity of healthcare services within the European Union.

Or. fr

PE653.822v01-00 208/276 AM\1207705EN.docx EN Amendment 388 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 27

Text proposed by the Commission Amendment

(27) The ERNs, established pursuant to (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Directive 2011/24/EU of the European Parliament and the Council16 are virtual Parliament and the Council16 are virtual networks involving healthcare providers networks involving healthcare providers across Europe. They aim to facilitate across Europe. They aim to facilitate discussion on complex or rare diseases and discussion on complex or rare diseases and conditions that require highly specialised conditions that require highly specialised treatment, and concentrated knowledge and treatment, and concentrated knowledge and resources. As the Networks can improve resources. As the Networks can improve the access to diagnosis and the provision of the access to diagnosis and the provision of high-quality healthcare to patients with rare high-quality healthcare to patients with rare conditions and can be focal points for conditions and can be focal points for medical training and research and medical training and research and dissemination of information, the dissemination of information, the Programme should contribute to the Programme should contribute to the upscaling of networking through the ERNs, upscaling of networking through the ERNs, and other transnational networks. It should and other transnational networks. It should consider the extension of ERNs beyond consider the extension of ERNs beyond rare diseases to communicable and non- rare diseases, supporting the creation of communicable diseases such as cancer. new ERNs to cover infectious diseases, complex pregnancies and complex mental health diseases and cancer and paediatric cancer. ______16 Directive 2011/24/EU of the European 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March Parliament and of the Council of 9 March 2011 on the application of patients’ rights 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 4.4.2011, p. 45).

Or. en

Amendment 389 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Christel Schaldemose

AM\1207705EN.docx 209/276 PE653.822v01-00 EN Proposal for a regulation Recital 27

Text proposed by the Commission Amendment

(27) The ERNs, established pursuant to (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Directive 2011/24/EU of the European Parliament and the Council16 are virtual Parliament and the Council16 are virtual networks involving healthcare providers networks involving healthcare providers across Europe. They aim to facilitate across Europe. They aim to facilitate discussion on complex or rare diseases and discussion on complex or rare diseases and conditions that require highly specialised conditions that require highly specialised treatment, and concentrated knowledge and treatment, and concentrated knowledge and resources. As the Networks can improve resources. As the Networks can improve the access to diagnosis and the provision of the access to diagnosis and the provision of high-quality healthcare to patients with rare high-quality healthcare to patients with rare conditions and can be focal points for conditions and can be focal points for medical training and research and medical training and research and dissemination of information, the dissemination of information, the Programme should contribute to the Programme should contribute to the upscaling of networking through the ERNs, upscaling of networking through the ERNs, and other transnational networks. It should and other transnational networks. It should consider the extension of ERNs beyond consider the extension of ERNs beyond rare diseases to communicable and non- rare diseases to communicable and non- communicable diseases such as cancer. communicable diseases such as cardiovascular disease, cancer, chronic respiratory disease, diabetes and mental health conditions and other major chronic diseases, which require extensive knowledge sharing due to the complexity of cases and co-morbidities, and their increasing prevalence. ______16 Directive 2011/24/EU of the European 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March Parliament and of the Council of 9 March 2011 on the application of patients’ rights 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 4.4.2011, p. 45).

Or. en

Amendment 390 Mick Wallace

PE653.822v01-00 210/276 AM\1207705EN.docx EN Proposal for a regulation Recital 27

Text proposed by the Commission Amendment

(27) The ERNs, established pursuant to (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Directive 2011/24/EU of the European Parliament and the Council16 are virtual Parliament and the Council16 are virtual networks involving healthcare providers networks involving healthcare providers across Europe. They aim to facilitate across Europe. They aim to facilitate discussion on complex or rare diseases and discussion on complex or rare diseases and conditions that require highly specialised conditions that require highly specialised treatment, and concentrated knowledge and treatment, and concentrated knowledge and resources. As the Networks can improve resources. As the Networks can improve the access to diagnosis and the provision of the access to diagnosis and the provision of high-quality healthcare to patients with rare high-quality healthcare to patients with rare conditions and can be focal points for conditions and can be focal points for medical training and research and medical training and research and dissemination of information, the dissemination of information, the Programme should contribute to the Programme should contribute to the upscaling of networking through the ERNs, upscaling of networking through the ERNs, and other transnational networks. It should and other transnational networks. It should consider the extension of ERNs beyond consider the extension of ERNs beyond rare diseases to communicable and non- rare diseases to communicable and non- communicable diseases such as cancer. communicable diseases such as cancer, chronic respiratory disease, diabetes and mental health conditions and other major chronic diseases, which require extensive knowledge sharing due to the complexity of cases and co-morbidities, and their increasing prevalence. ______16 Directive 2011/24/EU of the European 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March Parliament and of the Council of 9 March 2011 on the application of patients’ rights 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 4.4.2011, p. 45).

Or. en

Justification

The high prevalence and mortality from chronic diseases, further increased by COVID-19, suggests that a similar approach to ERNs for rare diseases be taken for this group of diseases. It would also contribute to provide patients across Europe with the same chances of receiving high-quality medical care.

AM\1207705EN.docx 211/276 PE653.822v01-00 EN Amendment 391 Michèle Rivasi

Proposal for a regulation Recital 27

Text proposed by the Commission Amendment

(27) The ERNs, established pursuant to (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Directive 2011/24/EU of the European Parliament and the Council16 are virtual Parliament and the Council16 are virtual networks involving healthcare providers networks involving healthcare providers across Europe. They aim to facilitate across Europe. They aim to facilitate discussion on complex or rare diseases and discussion on complex or rare diseases and conditions that require highly specialised conditions that require highly specialised treatment, and concentrated knowledge and treatment, and concentrated knowledge and resources. As the Networks can improve resources. As the Networks can improve the access to diagnosis and the provision of the access to diagnosis and the provision of high-quality healthcare to patients with rare high-quality healthcare to patients with rare conditions and can be focal points for conditions and can be focal points for medical training and research and medical training and research and dissemination of information, the dissemination of information, the Programme should contribute to the Programme should contribute to the upscaling of networking through the ERNs, upscaling of networking through the ERNs, and other transnational networks. It should and other transnational networks. It should consider the extension of ERNs beyond consider the extension of ERNs beyond rare diseases to communicable and non- rare diseases to communicable and non- communicable diseases such as cancer. communicable diseases such as cardiovascular disease, cancer, chronic respiratory disease, diabetes and mental health conditions and other major chronic diseases, which require extensive knowledge sharing due to the complexity of cases and co-morbidities; ______16 Directive 2011/24/EU of the European 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March Parliament and of the Council of 9 March 2011 on the application of patients’ rights 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 4.4.2011, p. 45).

Or. en

Amendment 392 Frédérique Ries

PE653.822v01-00 212/276 AM\1207705EN.docx EN Proposal for a regulation Recital 27

Text proposed by the Commission Amendment

(27) The ERNs, established pursuant to (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Directive 2011/24/EU of the European Parliament and the Council16 are virtual Parliament and the Council16 are virtual networks involving healthcare providers networks involving healthcare providers across Europe. They aim to facilitate across Europe. They aim to facilitate discussion on complex or rare diseases and discussion on complex or rare diseases and conditions that require highly specialised conditions that require highly specialised treatment, and concentrated knowledge and treatment, and concentrated knowledge and resources. As the Networks can improve resources. As the Networks can improve the access to diagnosis and the provision of the access to diagnosis and the provision of high-quality healthcare to patients with rare high-quality healthcare to patients with rare conditions and can be focal points for conditions and can be focal points for medical training and research and medical training and research and dissemination of information, the dissemination of information, the Programme should contribute to the Programme should contribute to the upscaling of networking through the ERNs, upscaling of networking through the ERNs, and other transnational networks. It should and other transnational networks. It should consider the extension of ERNs beyond consider the extension of ERNs beyond rare diseases to communicable and non- rare diseases to communicable and non- communicable diseases such as cancer. communicable diseases such as cancer, without impacting the efficiency of the 24 existing ERNs which are working on a range of thematic issues including bone disorders, childhood cancer and immunodeficiency. ______16 Directive 2011/24/EU of the European 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March Parliament and of the Council of 9 March 2011 on the application of patients’ rights 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 4.4.2011, p. 45).

Or. en

Amendment 393 Mairead McGuinness

Proposal for a regulation Recital 27

AM\1207705EN.docx 213/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(27) The ERNs, established pursuant to (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Directive 2011/24/EU of the European Parliament and the Council16 are virtual Parliament and the Council16 are virtual networks involving healthcare providers networks involving healthcare providers across Europe. They aim to facilitate across Europe. They aim to facilitate discussion on complex or rare diseases and discussion on complex or rare diseases and conditions that require highly specialised conditions that require highly specialised treatment, and concentrated knowledge and treatment, and concentrated knowledge and resources. As the Networks can improve resources. As the Networks can improve the access to diagnosis and the provision of the access to diagnosis and the provision of high-quality healthcare to patients with rare high-quality healthcare to patients with rare conditions and can be focal points for conditions and can be focal points for medical training and research and medical training and research and dissemination of information, the dissemination of information, the Programme should contribute to the Programme should contribute to the upscaling of networking through the ERNs, upscaling of networking through the ERNs, and other transnational networks. It should and other transnational networks. It should consider the extension of ERNs beyond consider the extension of ERNs beyond rare diseases to communicable and non- rare diseases to communicable and non- communicable diseases such as cancer. communicable diseases such as cancer, cardiovascular disease, chronic respiratory disease, mental health conditions and other major chronic diseases. ______16 Directive 2011/24/EU of the European 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March Parliament and of the Council of 9 March 2011 on the application of patients’ rights 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 4.4.2011, p. 45).

Or. en

Amendment 394 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 27

PE653.822v01-00 214/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(27) The ERNs, established pursuant to (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Directive 2011/24/EU of the European Parliament and the Council16 are virtual Parliament and the Council16 are virtual networks involving healthcare providers networks involving healthcare providers across Europe. They aim to facilitate across Europe. They aim to facilitate discussion on complex or rare diseases and discussion on complex or rare diseases and conditions that require highly specialised conditions that require highly specialised treatment, and concentrated knowledge and treatment, and concentrated knowledge and resources. As the Networks can improve resources. As the Networks can improve the access to diagnosis and the provision of the access to diagnosis and the provision of high-quality healthcare to patients with rare high-quality healthcare to patients with rare conditions and can be focal points for conditions and can be focal points for medical training and research and medical training and research and dissemination of information, the dissemination of information, the Programme should contribute to the Programme should contribute to the upscaling of networking through the ERNs, upscaling of networking through the ERNs, and other transnational networks. It should and other transnational networks. It should consider the extension of ERNs beyond consider the extension of ERNs beyond rare diseases to communicable and non- rare diseases to complex communicable communicable diseases such as cancer. and non-communicable diseases such as cancer and in the field of health crises management. ______16 Directive 2011/24/EU of the European 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March Parliament and of the Council of 9 March 2011 on the application of patients’ rights 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 4.4.2011, p. 45).

Or. en

Amendment 395 Joanna Kopcińska

Proposal for a regulation Recital 27

Text proposed by the Commission Amendment

(27) The ERNs, established pursuant to (27) The ERNs, established pursuant to Directive 2011/24/EU of the European Directive 2011/24/EU of the European Parliament and the Council16 are virtual Parliament and the Council16 are virtual networks involving healthcare providers networks involving healthcare providers

AM\1207705EN.docx 215/276 PE653.822v01-00 EN across Europe. They aim to facilitate across Europe. They aim to facilitate discussion on complex or rare diseases and discussion on complex or rare diseases and conditions that require highly specialised conditions that require highly specialised treatment, and concentrated knowledge and treatment, and concentrated knowledge and resources. As the Networks can improve resources. As the Networks can improve the access to diagnosis and the provision of the access to diagnosis and the provision of high-quality healthcare to patients with rare high-quality healthcare to patients with rare conditions and can be focal points for conditions and can be focal points for medical training and research and medical training and research and dissemination of information, the dissemination of information, the Programme should contribute to the Programme should contribute to the upscaling of networking through the ERNs, upscaling of networking through the ERNs, and other transnational networks. It should and other transnational networks. It should consider the extension of ERNs beyond consider the extension of ERNs beyond rare diseases to communicable and non- rare diseases to communicable and chronic communicable diseases such as cancer. non-communicable diseases such as cancer and neurodegenerative diseases. ______16 Directive 2011/24/EU of the European 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March Parliament and of the Council of 9 March 2011 on the application of patients’ rights 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, in cross-border healthcare (OJ L 88, 4.4.2011, p. 45). 4.4.2011, p. 45).

Or. en

Amendment 396 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Linea Søgaard-Lidell, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 27 a (new)

Text proposed by the Commission Amendment

(27a) The programme should support the EU-wide mobility of healthcare professionals, during both their education and professional careers through Erasmus + fundings, and of their particular role in improving knowledge and expertise on health threats. The programme should also facilitate the implementation of the Professional Qualifications Directive to ensure better

PE653.822v01-00 216/276 AM\1207705EN.docx EN mutual recognition of qualifications of health professionals within the Union.

Or. en

Amendment 397 Frédérique Ries

Proposal for a regulation Recital 27 a (new)

Text proposed by the Commission Amendment

(27a) The ERNs face significant challenges to ensure they are financially sustainable and are able to operate effectively within and across national healthcare systems, as highlighted by the European Court of Auditors, in their “Special report no 07/2019: EU actions for cross-border healthcare”.

Or. en

Amendment 398 Margarita de la Pisa Carrión

Proposal for a regulation Recital 27 a (new)

Text proposed by the Commission Amendment

(27a) Priority should be given to clinical genomics and disease prediction programmes based on the genetic make- up of individuals (personalised or precision medicine), and the EU should lead this initiative.

Or. es

Amendment 399 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie

AM\1207705EN.docx 217/276 PE653.822v01-00 EN Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 27 b (new)

Text proposed by the Commission Amendment

(27b) The programme should facilitate the coordination and pooling of European multicentre clinical trials and promote the research and training actions of future European universities networks.

Or. en

Amendment 400 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 27 c (new)

Text proposed by the Commission Amendment

(27c) The programme should guarantee the sustainable funding of European research consortia on medicines, vaccines and biological tests designed for specific infectious and transmissible diseases.

Or. en

Amendment 401 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Linea Søgaard-Lidell, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 27 d (new)

Text proposed by the Commission Amendment

(27d) The Programme should take

PE653.822v01-00 218/276 AM\1207705EN.docx EN concrete actions against rare, complex and low-prevalence diseases. Early detection must be facilitated and projects such as “Rare 2030” encouraging with the objective to set up concrete and innovative policies for developing research and improving the lives of patients.

Or. en

Amendment 402 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 27 e (new)

Text proposed by the Commission Amendment

(27e) The programme should facilitate the revision of the EU-OSHA’s mandate to promote healthy and safe workplaces across the Union and to support the Agency’s activities and analysis on occupational safety and health. The Commission should propose a new EU Strategic Framework on Occupational Safety and Health for the period 2021 – 2027 and continue updating the directive on the protection of workers from the risks related to carcinogens or mutagens at work. The programme should also support actions to facilitate people’s return to the workplace after long-term sick leave and to better include people who are chronically sick or have a disability in the workforce.

Or. en

Amendment 403 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller,

AM\1207705EN.docx 219/276 PE653.822v01-00 EN Susana Solís Pérez, Linea Søgaard-Lidell, Chrysoula Zacharopoulou, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 27 f (new)

Text proposed by the Commission Amendment

(27f) The programme should effectively guarantee safe and timely access to sexual and reproductive health and rights (SRHR), goods (e.g. medicines, contraceptives) and services (e.g. sex education, safe abortions).

Or. en

Amendment 404 Pascal Arimont, Cindy Franssen, Esther de Lange

Proposal for a regulation Recital 30

Text proposed by the Commission Amendment

(30) In order to optimise the added value (30) In order to optimise the added value and impact from investments funded and impact from investments funded wholly or in part through the budget of the wholly or in part through the budget of the Union, synergies should be sought in Union, synergies should be sought in particular between the Programme for the particular between the Programme for the Union's action in the field of health and Union's action in the field of health and other Union programmes, including those other Union programmes, including those under shared-management. To maximise under shared-management, notably the those synergies, key enabling mechanisms Interreg programme which already should be ensured, including cumulative addresses cross-border cooperation in the funding in an action from the Programme field of health and helps to facilitate the for the Union's action in the field of health cross-border mobility of patients and and another Union programme, as long as health professionals, and to develop such cumulative funding does not exceed access to high quality healthcare through the total eligible costs of the action. For the use of common equipment, shared that purpose, this Regulation should set out services and joint facilities in cross-border appropriate rules, in particular on the areas. To maximise those synergies, key possibility to declare the same cost or enabling mechanisms should be ensured, expenditure on a pro-rata basis to including cumulative funding in an action Programme for the Union's action in the from the Programme for the Union's action field of health and another Union in the field of health and another Union programme, as long as such cumulative

PE653.822v01-00 220/276 AM\1207705EN.docx EN programme. 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.

Or. en

Amendment 405 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 30

Text proposed by the Commission Amendment

(30) In order to optimise the added value (30) In order to optimise the added value and impact from investments funded and impact from investments funded wholly or in part through the budget of the wholly or in part through the budget of the Union, synergies should be sought in Union, synergies should be sought in particular between the Programme for the particular between the Programme for the Union's action in the field of health and Union's action in the field of health and other Union programmes, including those other Union programmes, including those under shared-management. To maximise under shared-management and the Union those synergies, key enabling mechanisms Agencies. To maximise those synergies, should be ensured, including cumulative key enabling mechanisms should be funding in an action from the Programme ensured, including cumulative funding in for the Union's action in the field of health an action from the Programme for the and another Union programme, as long as Union's action in the field of health and such cumulative funding does not exceed another Union programme, as long as such the total eligible costs of the action. For cumulative funding does not exceed the that purpose, this Regulation should set out total eligible costs of the action. For that appropriate rules, in particular on the purpose, this Regulation should set out possibility to declare the same cost or appropriate rules, in particular on the expenditure on a pro-rata basis to possibility to declare the same cost or Programme for the Union's action in the expenditure on a pro-rata basis to field of health and another Union Programme for the Union's action in the programme. field of health and another Union programme guaranteeing detailed and transparent reporting.

Or. en

AM\1207705EN.docx 221/276 PE653.822v01-00 EN Amendment 406 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 30

Text proposed by the Commission Amendment

(30) In order to optimise the added value (30) In order to optimise the added value and impact from investments funded and impact from investments funded wholly or in part through the budget of the wholly or in part through the budget of the Union, synergies should be sought in Union, synergies should be sought in particular between the Programme for the particular between the Programme for the Union's action in the field of health and Union's action in the field of health and other Union programmes, including those other Union programmes, including those under shared-management. To maximise under shared-management and the EU those synergies, key enabling mechanisms agencies. To maximise those synergies should be ensured, including cumulative and avoid duplications, key enabling funding in an action from the Programme mechanisms should be ensured, including for the Union's action in the field of health cumulative funding in an action from the and another Union programme, as long as Programme for the Union's action in the such cumulative funding does not exceed field of health and another Union the total eligible costs of the action. For programme, as long as such cumulative that purpose, this Regulation should set out funding does not exceed the total eligible appropriate rules, in particular on the costs of the action. For that purpose, this possibility to declare the same cost or Regulation should set out appropriate rules, expenditure on a pro-rata basis to in particular on the possibility to declare Programme for the Union's action in the the same cost or expenditure on a pro-rata field of health and another Union basis to Programme for the Union's action programme. in the field of health and another Union programme.

Or. en

Amendment 407 Edina Tóth

Proposal for a regulation Recital 31

Text proposed by the Commission Amendment

(31) Given the specific nature of the (31) Given the specific nature of the objectives and actions covered by the objectives and actions covered by the Programme, the respective competent Programme, the respective competent

PE653.822v01-00 222/276 AM\1207705EN.docx EN authorities of the Member States are best authorities of the Member States are best placed in some cases to implement the placed in some cases to implement the related activities. Those authorities, related activities. Those authorities, designated by the Member States designated by the Member States themselves, should therefore be considered themselves, should therefore be considered to be identified beneficiaries for the to be identified beneficiaries for the purpose of Article 195 of the Financial purpose of Article 195 of the Financial Regulation and the grants be awarded to Regulation and the grants be awarded to such authorities without prior publication such authorities without prior publication of calls for proposals. of calls for proposals. Investments from EU4Health programme should be implemented in close cooperation with Member States especially in areas falling under national competences.

Or. en

Amendment 408 Pascal Arimont, Cindy Franssen, Esther de Lange

Proposal for a regulation Recital 31

Text proposed by the Commission Amendment

(31) Given the specific nature of the (31) Given the specific nature of the objectives and actions covered by the objectives and actions covered by the Programme, the respective competent Programme, the respective competent authorities of the Member States are best authorities of the Member States and, in placed in some cases to implement the the cross-border context, the Interreg related activities. Those authorities, programmes are best placed in some cases designated by the Member States to implement the related activities. Those themselves, should therefore be considered authorities and Interreg programmes, to be identified beneficiaries for the designated by the Member States purpose of Article 195 of the Financial themselves, should therefore be considered Regulation and the grants be awarded to to be identified beneficiaries for the such authorities without prior publication purpose of Article 195 of the Financial of calls for proposals. Regulation and the grants be awarded to such authorities without prior publication of calls for proposals.

Or. en

Amendment 409 Chrysoula Zacharopoulou, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos,

AM\1207705EN.docx 223/276 PE653.822v01-00 EN Karen Melchior, Sophia in 't Veld, Samira Rafaela, Hilde Vautmans, Susana Solís Pérez, Maria Noichl

Proposal for a regulation Recital 33

Text proposed by the Commission Amendment

(33) Given the common agreed values of (33) Given the common agreed values of solidarity towards equitable and universal solidarity towards equitable and universal coverage of quality health services as a coverage of quality health services as a basis for the Union’s policies in this area basis for the Union’s policies in this area and that the Union has a central role to play and that the Union has a central role to play in accelerating progress on global health in accelerating progress on global health challenges19 , the Programme should challenges19 , the Programme should support the Union’s contribution to support the Union’s contribution to international and global health initiatives international and global health initiatives with a view to improve health, address with a view to improve health, including inequalities and increase protection against sexual and reproductive health, address global health threats. inequalities, in particular gender inequalities, and increase protection against global health threats. ______19 Council conclusions on the EU role in 19 Council conclusions on the EU role in Global Health, 3011th Foreign Affairs Global Health, 3011th Foreign Affairs Council meeting, Brussels, 10 May 2010. Council meeting, Brussels, 10 May 2010.

Or. en

Amendment 410 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Recital 33

Text proposed by the Commission Amendment

(33) Given the common agreed values of (33) Given the common agreed values of solidarity towards equitable and universal solidarity towards equitable and universal coverage of quality health services as a coverage of quality health services as a basis for the Union’s policies in this area basis for the Union’s policies in this area and that the Union has a central role to play and that the Union has a central role to play in accelerating progress on global health in accelerating progress on global health challenges19 , the Programme should challenges19 , the Programme should, in support the Union’s contribution to synergy and complementarity with other international and global health initiatives relevant Union programmes, support the

PE653.822v01-00 224/276 AM\1207705EN.docx EN with a view to improve health, address Union’s contribution to international and inequalities and increase protection against global health initiatives with a view to global health threats. improve health, address inequalities and increase protection against global health threats. ______19 Council conclusions on the EU role in 19 Council conclusions on the EU role in Global Health, 3011th Foreign Affairs Global Health, 3011th Foreign Affairs Council meeting, Brussels, 10 May 2010. Council meeting, Brussels, 10 May 2010.

Or. en

Amendment 411 Pascal Arimont, Cindy Franssen, Esther de Lange

Proposal for a regulation Recital 33

Text proposed by the Commission Amendment

(33) Given the common agreed values of (33) Given the common agreed values of solidarity towards equitable and universal solidarity towards accessible, equitable and coverage of quality health services as a universal coverage of quality health basis for the Union’s policies in this area services, including in a cross-border and that the Union has a central role to play context, as a basis for the Union’s policies in accelerating progress on global health in this area and that the Union has a central challenges19 , the Programme should role to play in accelerating progress on support the Union’s contribution to global health challenges19 , the Programme international and global health initiatives should support the Union’s contribution to with a view to improve health, address international and global health initiatives inequalities and increase protection against with a view to improve health, address global health threats. inequalities and increase protection against global health threats. ______19 Council conclusions on the EU role in 19 Council conclusions on the EU role in Global Health, 3011th Foreign Affairs Global Health, 3011th Foreign Affairs Council meeting, Brussels, 10 May 2010. Council meeting, Brussels, 10 May 2010.

Or. en

Amendment 412 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert

AM\1207705EN.docx 225/276 PE653.822v01-00 EN Hajšel

Proposal for a regulation Recital 34

Text proposed by the Commission Amendment

(34) In order to maximise the (34) In order to maximise the effectiveness and efficiency of actions at effectiveness and efficiency of actions at Union and international level, cooperation Union and international level, cooperation should be developed with relevant should be developed with the Member international organisations such as the States and with relevant international United Nations and its specialised organisations such as the United Nations agencies, in particular the WHO, the World and its specialised agencies, in particular Bank, as well as with the Council of the WHO, the World Bank, as well as with Europe and the Organisation for Economic the Council of Europe and the Organisation Co-operation and Development (OECD) to for Economic Co-operation and implement the Programme. Pursuant to Development (OECD) to implement the Article 94 of Council Decision Programme. Pursuant to Article 94 of 2013/755/EU20 , persons and entities Council Decision 2013/755/EU20 , persons established in Overseas Countries and and entities established in Overseas Territories (OCTs) are eligible for funding Countries and Territories (OCTs) are subject to the rules and objectives of the eligible for funding subject to the rules and Programme and possible arrangements objectives of the Programme and possible applicable to the Member State to which arrangements applicable to the Member the relevant OCTs are linked. State to which the relevant OCTs are linked. ______20 Council Decision 2013/755/EU of 25 20 Council Decision 2013/755/EU of 25 November 2013 on the association of the November 2013 on the association of the overseas countries and territories with the overseas countries and territories with the European Union ( ‘Overseas Association European Union ( ‘Overseas Association Decision’ ) (OJ L 344, 19.12.2013, p. 1). Decision’ ) (OJ L 344, 19.12.2013, p. 1).

Or. en

Amendment 413 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Chrysoula Zacharopoulou, Linea Søgaard-Lidell, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 36

PE653.822v01-00 226/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(36) Cooperation with third countries (36) Cooperation with third countries should be strengthened on the exchange of should be strengthened on the exchange of knowledge and best practices in health knowledge and best practices in health systems preparedness and response. systems preparedness and response. The programme should help building a strong and effective partnership between the Union and Africa and prioritise health systems strengthening, universal access to health services and global health research and development in the framework of the EU-Africa Strategy.

Or. en

Amendment 414 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 39 a (new)

Text proposed by the Commission Amendment

(39a) The preamble to the Paris Agreement acknowledges the “right to health” as a key right; the article 4(1)(f) of the UNFCCC states that all Parties thereto should employ “appropriate methods, for example impacts assessments, formulated and determined nationally with a view to minimising adverse effects on the economy, on public health and on the quality of the environment, of projects or measures undertaken by them to mitigate or adapt climate change".

Or. en

Amendment 415 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie

AM\1207705EN.docx 227/276 PE653.822v01-00 EN Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 39 b (new)

Text proposed by the Commission Amendment

(39b) According to the WHO, climate change affects the social and environmental determinants of health- clean air, safe drinking water, sufficient food and secure shelter-and that 250 000 additional deaths, from malnutrition, maladria, diarrhoea and heat stress, are expected every year between 2030 and 2050, with extreme high air temperatures contributing directly to deaths particularly amongst the elderly and vulnerable individuals. Through flood, heatwaves, drought and fires, climate change has a considerable impact on human health, including under nutrition, cardiovascular and respiratory diseases, and vector-borne infections.

Or. en

Amendment 416 Rob Rooken

Proposal for a regulation Recital 40

Text proposed by the Commission Amendment

(40) Reflecting the importance of deleted 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

PE653.822v01-00 228/276 AM\1207705EN.docx EN Programme’s preparation and implementation, and reassessed in the context of its mid-term evaluation.

Or. nl

Amendment 417 Margarita de la Pisa Carrión

Proposal for a regulation Recital 40

Text proposed by the Commission Amendment

(40) Reflecting the importance of deleted 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.

Or. es

Amendment 418 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, María Soraya Rodríguez Ramos

Proposal for a regulation Recital 40

Text proposed by the Commission Amendment

(40) Reflecting the importance of (40) Reflecting the importance of tackling climate change in line with the tackling climate change in line with the Union's commitments to implement the Union's commitments to implement the Paris Agreement and the United Nations Paris Agreement and the United Nations

AM\1207705EN.docx 229/276 PE653.822v01-00 EN Sustainable Development Goals, this Sustainable Development Goals, this Programme will contribute to mainstream Programme will contribute to mainstream climate action in the Union's policies and climate action in the Union's policies and to the achievement of an overall target of to the achievement of an overall target of 25 % of the EU budget expenditures 30 % of the EU budget expenditures supporting climate objectives. Relevant supporting climate objectives. Relevant actions will be identified during the actions will be identified during the Programme's preparation and Programme's preparation and implementation, and reassessed in the implementation, and reassessed in the context of its mid-term evaluation. context of its mid-term evaluation.

Or. en

Amendment 419 Pascal Arimont, Cindy Franssen, Esther de Lange

Proposal for a regulation Recital 42

Text proposed by the Commission Amendment

(42) The implementation of the (42) The implementation of the Programme should be such that the Programme should be such that the responsibilities of the Member States, for responsibilities of the Member States, for the definition of their health policy and for the definition of their health policy and for the organisation and delivery of health the organisation and delivery of health services and medical care, are respected. services and medical care, are respected. However, with a view to improving the complementarity of their health services and their conditions of mobility for patients and healthcare professionals in cross-border areas.

Or. en

Amendment 420 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Recital 43

PE653.822v01-00 230/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(43) Given the nature and potential scale (43) Given the nature and potential scale of cross-border threats to human health, the of cross-border threats to human health, the objective of protecting people in the Union objective of protecting people in the Union from such threats and to increase crisis from such threats and to increase crisis prevention and preparedness cannot be prevention and preparedness cannot be sufficiently achieved by the Member States sufficiently achieved by the Member States acting alone. In accordance with the acting alone. In accordance with the principle of subsidiarity as set out in principle of subsidiarity as set out in Article 5 of the Treaty on the European Article 5 of the Treaty on the European Union, action at Union level can also be Union, action at Union level can also be taken to support Member States’ efforts in taken to support Member States’ efforts in the pursuit of a high level of protection of the pursuit of a high level of protection of public health, to improve the availability public health, to improve the availability, and affordability in the Union of sustainability, acceptability, accessibility medicines, medical devices and other crisis and affordability in the Union of relevant products, to support innovation medicines, medical devices and other and to support integrated and coordinated health relevant products, to support work and implementation of best practices innovation and to support integrated and among Member States, and to address coordinated work and implementation of inequalities in access to health throughout best practices among Member States, and the EU in a manner that creates efficiency to address inequalities and inequities in gains and value-added impacts that could access to health throughout the EU in a not be generated by action taken at national manner that creates efficiency gains and level while respecting the Member States’ value-added impacts that could not be competence and responsibility in the areas generated by action taken at national level covered by the Programme. In accordance while respecting the Member States’ with the principle of proportionality, as set competence and responsibility in the areas out in that Article, this Regulation does not covered by the Programme. In accordance go beyond what is necessary in order to with the principle of proportionality, as set achieve those objectives. out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.

Or. en

Amendment 421 Pascal Arimont, Cindy Franssen, Esther de Lange

Proposal for a regulation Recital 43

Text proposed by the Commission Amendment

(43) Given the nature and potential scale (43) Given the nature and potential scale

AM\1207705EN.docx 231/276 PE653.822v01-00 EN of cross-border threats to human health, the of cross-border threats to human health, the objective of protecting people in the Union objective of protecting people in the Union from such threats and to increase crisis from such threats and to increase crisis prevention and preparedness cannot be prevention and preparedness cannot be sufficiently achieved by the Member States sufficiently achieved by the Member States acting alone. In accordance with the acting alone. In accordance with the principle of subsidiarity as set out in principle of subsidiarity as set out in Article 5 of the Treaty on the European Article 5 of the Treaty on the European Union, action at Union level can also be Union, action at Union level should also be taken to support Member States’ efforts in taken to support Member States’ efforts in the pursuit of a high level of protection of the pursuit of a high level of protection of public health, to improve the availability public health, to improve the availability and affordability in the Union of and affordability in the Union of medicines, medical devices and other crisis medicines, medical devices and other crisis relevant products, to support innovation relevant products and services, to support and to support integrated and coordinated innovation and to support integrated and work and implementation of best practices coordinated work and implementation of among Member States, and to address best practices among Member States and inequalities in access to health throughout among their regions, and to address the EU in a manner that creates efficiency inequalities in access to health throughout gains and value-added impacts that could the EU in a manner that creates efficiency not be generated by action taken at national gains and value-added impacts that could level while respecting the Member States’ not be generated by action taken at national competence and responsibility in the areas level while respecting the Member States’ covered by the Programme. In accordance competence and responsibility in the areas with the principle of proportionality, as set covered by the Programme. In accordance out in that Article, this Regulation does not with the principle of proportionality, as set go beyond what is necessary in order to out in that Article, this Regulation does not achieve those objectives. go beyond what is necessary in order to achieve those objectives.

Or. en

Amendment 422 Michèle Rivasi

Proposal for a regulation Recital 43

Text proposed by the Commission Amendment

(43) Given the nature and potential scale (43) Given the nature and potential scale of cross-border threats to human health, the of cross-border threats to human health, the objective of protecting people in the Union objective of protecting people in the Union from such threats and to increase crisis from such threats and to increase crisis prevention and preparedness cannot be prevention and preparedness cannot be sufficiently achieved by the Member States sufficiently achieved by the Member States

PE653.822v01-00 232/276 AM\1207705EN.docx EN acting alone. In accordance with the acting alone. In accordance with the principle of subsidiarity as set out in principle of subsidiarity as set out in Article 5 of the Treaty on the European Article 5 of the Treaty on the European Union, action at Union level can also be Union, action at Union level can also be taken to support Member States’ efforts in taken to support Member States’ efforts in the pursuit of a high level of protection of the pursuit of a high level of protection of public health, to improve the availability public health, to improve the availability, and affordability in the Union of accessibility, safety and affordability in the medicines, medical devices and other crisis Union of medicines, medical devices and relevant products, to support innovation other crisis relevant products, to support and to support integrated and coordinated innovation and to support integrated and work and implementation of best practices coordinated work and implementation of among Member States, and to address best practices among Member States, and inequalities in access to health throughout to address inequalities in access to health the EU in a manner that creates efficiency throughout the EU in a manner that creates gains and value-added impacts that could efficiency gains and value-added impacts not be generated by action taken at national that could not be generated by action taken level while respecting the Member States’ at national level while respecting the competence and responsibility in the areas Member States’ competence and covered by the Programme. In accordance responsibility in the areas covered by the with the principle of proportionality, as set Programme. In accordance with the out in that Article, this Regulation does not principle of proportionality, as set out in go beyond what is necessary in order to that Article, this Regulation does not go achieve those objectives. beyond what is necessary in order to achieve those objectives.

Or. en

Amendment 423 Jessica Polfjärd

Proposal for a regulation Recital 43

Text proposed by the Commission Amendment

(43) Given the nature and potential scale (43) Given the nature and potential scale of cross-border threats to human health, the of cross-border threats to human health, the objective of protecting people in the Union objective of protecting people in the Union from such threats and to increase crisis from such threats and to increase crisis prevention and preparedness cannot be prevention and preparedness cannot be sufficiently achieved by the Member States sufficiently achieved by the Member States acting alone. In accordance with the acting alone. In accordance with the principle of subsidiarity as set out in principle of subsidiarity as set out in Article 5 of the Treaty on the European Article 5 of the Treaty on the European Union, action at Union level can also be Union, action at Union level can also be taken to support Member States’ efforts in taken to support Member States’ efforts in

AM\1207705EN.docx 233/276 PE653.822v01-00 EN the pursuit of a high level of protection of the pursuit of a high level of protection of public health, to improve the availability public health, to improve the availability, and affordability in the Union of accessibility and affordability in the Union medicines, medical devices and other crisis of medicines, medical devices and other relevant products, to support innovation crisis relevant products, to support and to support integrated and coordinated innovation and to support integrated and work and implementation of best practices coordinated work and implementation of among Member States, and to address best practices among Member States, and inequalities in access to health throughout to address inequalities in access to health the EU in a manner that creates efficiency throughout the EU in a manner that creates gains and value-added impacts that could efficiency gains and value-added impacts not be generated by action taken at national that could not be generated by action taken level while respecting the Member States’ at national level while respecting the competence and responsibility in the areas Member States’ competence and covered by the Programme. In accordance responsibility in the areas covered by the with the principle of proportionality, as set Programme. In accordance with the out in that Article, this Regulation does not principle of proportionality, as set out in go beyond what is necessary in order to that Article, this Regulation does not go achieve those objectives. beyond what is necessary in order to achieve those objectives.

Or. en

Amendment 424 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Article 2 – paragraph 1 – point 3

Text proposed by the Commission Amendment

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

Or. en

Amendment 425 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie

PE653.822v01-00 234/276 AM\1207705EN.docx EN Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Article 2 – paragraph 1 – point 3

Text proposed by the Commission Amendment

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

Or. en

Amendment 426 Sara Cerdas, Tudor Ciuhodaru, Rovana Plumb, Milan Brglez, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Article 2 – paragraph 1 – point 4

Text proposed by the Commission Amendment

(4) ‘crisis relevant products’ means (4) ‘crisis relevant products’ means products and substances necessary, in the products; substances and tools necessary, context of a health crisis, to prevent, in the context of a health crisis, to prevent, diagnose or treat a disease and its diagnose or treat a disease and its consequences, included but not limited to: consequences, to the monitoring and the medicinal products - including vaccines - epidemiological surveillance of the and their intermediates, active diseases and infections, including but not pharmaceutical ingredients and raw limited to: medicinal products - including materials; medical devices; hospital and vaccines - and their intermediates, active medical equipment (such as ventilators, pharmaceutical ingredients and raw protective clothing and equipment, materials; medical devices; hospital and diagnostic materials and tools); personal medical equipment (such as ventilators, protective equipment; disinfectants and protective clothing and equipment, their intermediary products and raw diagnostic materials and tools); personal materials necessary for their production); protective equipment; disinfectants and their intermediary products and raw materials necessary for their production); training; infrastructure and technology to

AM\1207705EN.docx 235/276 PE653.822v01-00 EN increase the availability of data;

Or. en

Amendment 427 Mick Wallace, Clare Daly

Proposal for a regulation Article 2 – paragraph 1 – point 4

Text proposed by the Commission Amendment

(4) ‘crisis relevant products’ means (4) ‘crisis relevant products’ means products and substances necessary, in the products and substances necessary, in the context of a health crisis, to prevent, context of a health crisis, to prevent, diagnose or treat a disease and its diagnose or treat a disease and its consequences, included but not limited to: consequences, as well as other medical medicinal products - including vaccines - products and substances that remain and their intermediates, active essential during a health crisis, included pharmaceutical ingredients and raw but not limited to: medicinal products - materials; medical devices; hospital and including vaccines - and their medical equipment (such as ventilators, intermediates, active pharmaceutical protective clothing and equipment, ingredients and raw materials; medical diagnostic materials and tools); personal devices; hospital and medical equipment protective equipment; disinfectants and (such as ventilators, protective clothing and their intermediary products and raw equipment, diagnostic materials and tools); materials necessary for their production); personal protective equipment; disinfectants and their intermediary products and raw materials necessary for their production);

Or. en

Amendment 428 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Andreas Glück, María Soraya Rodríguez Ramos

Proposal for a regulation Article 2 – paragraph 1 – point 4

Text proposed by the Commission Amendment

(4) ‘crisis relevant products’ means (4) ‘crisis relevant products’ means products and substances necessary, in the products and substances necessary, in the

PE653.822v01-00 236/276 AM\1207705EN.docx EN context of a health crisis, to prevent, context of a health crisis, to prevent, diagnose or treat a disease and its diagnose or treat a disease and its consequences, included but not limited to: consequences, included but not limited to: medicinal products - including vaccines - medicinal products - including vaccines - and their intermediates, active and their intermediates, active pharmaceutical ingredients and raw pharmaceutical ingredients and raw materials; medical devices; hospital and materials; bloods products and organs; medical equipment (such as ventilators, medical devices; hospital and medical protective clothing and equipment, equipment (such as ventilators, protective diagnostic materials and tools); personal clothing and equipment, diagnostic protective equipment; disinfectants and materials and tools); personal protective their intermediary products and raw equipment; disinfectants and their materials necessary for their production); intermediary products and raw materials necessary for their production);

Or. en

Amendment 429 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Article 2 – paragraph 1 – point 5

Text proposed by the Commission Amendment

(5) ‘One Health approach’ means an (5) ‘One Health approach’ means an approach which recognises that human and approach which recognises the animal health are interconnected, that interconnection between the human, diseases may be transmitted from humans animal and environmental spheres, that to animals and vice versa and must diseases may be transmitted from one therefore be tackled in both, and that the pillar to another and must therefore be environment links humans and animals; tackled in a holistic approach;

Or. en

Amendment 430 Rob Rooken

Proposal for a regulation Article 2 – paragraph 1 – point 5

AM\1207705EN.docx 237/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

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

Or. nl

Amendment 431 Margarita de la Pisa Carrión

Proposal for a regulation Article 2 – paragraph 1 – point 5 a (new)

Text proposed by the Commission Amendment

(5a) The concept of ‘human health’ encompasses absolute respect for life in all its integral dimensions: physical, psychological, emotional and spiritual aspects that are all interconnected, unlike animal health. Such inclusion requires a holistic vision of an approach to comprehensive personal health, which preserves the freedom and dignity intrinsic to the human condition in all phases of life.

Or. es

Amendment 432 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Article 2 – paragraph 1 – point 5 a (new)

PE653.822v01-00 238/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(5a) “Environmental health” means aspects of human health, such as the quality of life, which are determined by the physical, chemical, biological, social, psychosocial and aesthetic factors of our environment;

Or. en

Amendment 433 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Sándor Rónai

Proposal for a regulation Article 2 – paragraph 1 – point 9

Text proposed by the Commission Amendment

(9) ‘serious cross-border threat to (9) ‘serious cross-border threat to health’ means a life- threatening or health’ means a life- threatening or otherwise serious hazard to health of otherwise serious hazard to health of biological, chemical, environmental or biological, chemical, radiological, nuclear, unknown origin which spreads or entails a environmental or unknown origin which significant risk of spreading across the spreads or entails a significant risk of national borders of Member States, and spreading across the national borders of which may necessitate coordination at Member States, and which may necessitate Union level in order to ensure a high level coordination at Union level in order to of human health protection; ensure a high level of human health protection;

Or. en

Amendment 434 Antoni Comín i Oliveres

Proposal for a regulation Article 2 – paragraph 1 – point 10 a (new)

Text proposed by the Commission Amendment

(10a) "health in all policies principle":

AM\1207705EN.docx 239/276 PE653.822v01-00 EN policy formulation approach that systematically considers health implications of decisions in all sectors, seeking synergies and avoiding the harmful effects on health of policies outside the health sector, in order to improve population's health and health equity. It develops the capacity of health policy professionals to recognise and support the development goals of other sectors, recognising the interdependent nature of social, economic, and environmental development;

Or. en

Amendment 435 Nicolae Ştefănuță

Proposal for a regulation Article 2 – paragraph 1 – point 10 a (new)

Text proposed by the Commission Amendment

(10a) ‘Commercial determinant of health’ means strategies and approaches used by the private sector to promote products and choices that are detrimental to health;

Or. en

Amendment 436 Nathalie Colin-Oesterlé

Proposal for a regulation Article 2 – paragraph 1 – point 10 a (new)

Text proposed by the Commission Amendment

(10a) ‘shortage’ means the temporary unavailability of a medicinal product as a result of an upstream stock shortage and/or a downstream supply shortage;

PE653.822v01-00 240/276 AM\1207705EN.docx EN Or. fr

Amendment 437 Biljana Borzan

Proposal for a regulation Article 2 – paragraph 1 – point 10 a (new)

Text proposed by the Commission Amendment

(10a) ‘Commercial determinant of health’ means commercial strategies and approaches used to promote products and choices that are detrimental to health.

Or. en

Amendment 438 Michèle Rivasi

Proposal for a regulation Article 2 – paragraph 1 – point 10 a (new)

Text proposed by the Commission Amendment

(10a) 'independent from industry' means receiving less than 20% of core funding as well as of project funding, respectively, from industry;

Or. en

Amendment 439 Nathalie Colin-Oesterlé

Proposal for a regulation Article 2 – paragraph 1 – point 10 b (new)

Text proposed by the Commission Amendment

(10b) ‘supply strain’ means that the manufacturer has insufficient quantities of medicines available, resulting in a

AM\1207705EN.docx 241/276 PE653.822v01-00 EN temporary inability to supply the usual market and a risk of disruption;

Or. fr

Amendment 440 Nathalie Colin-Oesterlé

Proposal for a regulation Article 2 – paragraph 1 – point 10 c (new)

Text proposed by the Commission Amendment

(10c) ‘supply disruption’ means the medicine is manufactured but not distributed to all pharmacies;

Or. fr

Amendment 441 Nathalie Colin-Oesterlé

Proposal for a regulation Article 2 – paragraph 1 – point 10 d (new)

Text proposed by the Commission Amendment

(10d) ‘stock shortage’ means a break in the manufacturing chain of the medicines, which may have several explanations: either the medicines cannot be manufactured or they are not allowed to enter the distribution channel because the quality of the medicines does not fully meet the required standards.

Or. fr

Amendment 442 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

PE653.822v01-00 242/276 AM\1207705EN.docx EN Proposal for a regulation Article 3 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

The Programme shall pursue the following The Programme shall pursue the following general objectives, in keeping with the general objectives, in keeping with the “One Health” approach where relevant: “One Health” and “Health in all policies” approaches where relevant:

Or. en

Amendment 443 Rob Rooken

Proposal for a regulation Article 3 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

The Programme shall pursue the following The Programme shall pursue the following general objectives, in keeping with the general objectives, pending the outcomes ‘One Health’ approach where relevant: of independent, science-based impact assessments:

Or. nl

Amendment 444 Michèle Rivasi

Proposal for a regulation Article 3 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

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

Or. en

Justification

The "One Health" Approach is always relevant.

AM\1207705EN.docx 243/276 PE653.822v01-00 EN Amendment 445 Michèle Rivasi

Proposal for a regulation Article 3 – paragraph 1 – point -1 (new)

Text proposed by the Commission Amendment

(-1) improve the health of people in the Union, including in particular by health promotion, disease prevention and by addressing health inequalities; (This should be the first of the general objectives.)

Or. en

Justification

With regard to the general objectives, the EU4Health Programme should first of all have the objective to improve the health of people in the Union and to address health inequalities. These should represent an objective in their own right and not be mixed with the objective to protect people in the Union from serious cross-border threats to health. Not should general health only be mentioned in the context of health systems (Art. 3, para 1, point 3). Improving public health in general as well as addressing health inequalities are also explicitly amongst the general objectives of the current programme and should therefore also be listed here as a general objective - in their own right.

Amendment 446 Véronique Trillet-Lenoir

Proposal for a regulation Article 3 – paragraph 1 – point -1 (new)

Text proposed by the Commission Amendment

(-1) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancer via the establishment of a European Cancer Institute;

Or. en

PE653.822v01-00 244/276 AM\1207705EN.docx EN Amendment 447 Cristian-Silviu Buşoi

Proposal for a regulation Article 3 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) protect people in the Union from (1) support health promotion, improve serious cross-border threats to health; health literacy, and disease prevention, reduce health inequalities, improve physical and mental health, protect people in the Union from serious cross-border threats to health;

Or. en

Amendment 448 Traian Băsescu

Proposal for a regulation Article 3 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) protect people in the Union from (1) protect people in the Union from serious cross-border threats to health; serious cross-border threats to health, including by ensuring equal protection for and full access to health rights for all European Union citizens, by promoting equal opportunities for, and access to, treatment, in a non-discriminatory manner, and by reducing disparities among Member States by allocating the resources needed to achieve this goal;

Or. ro

Amendment 449 Bartosz Arłukowicz, Jarosław Duda

Proposal for a regulation Article 3 – paragraph 1 – point 1

AM\1207705EN.docx 245/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(1) protect people in the Union from (1) protect people in the Union from serious cross-border threats to health; serious cross-border threats to health, including measures to support health promotion and disease prevention, reduce health inequalities, and improve physical and mental health;

Or. pl

Amendment 450 Joanna Kopcińska

Proposal for a regulation Article 3 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) protect people in the Union from (1) support health promotion, health serious cross-border threats to health; literacy and disease prevention, reduce health inequalities, improve physical and mental health, protect people in the Union from serious cross-border threats to health;

Or. en

Amendment 451 Mick Wallace

Proposal for a regulation Article 3 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) protect people in the Union from (1) support health promotion and serious cross-border threats to health; disease prevention, reduce health inequalities, improve physical and mental health, protect people in the Union from serious cross-border threats to health;

Or. en

PE653.822v01-00 246/276 AM\1207705EN.docx EN Justification

In order to protect people in the Union from serious cross-border threats to health, it is necessary to ensure that the general health status in all strata of the population is good. COVID-19 has shown how people with pre-existing conditions, such as cardiovascular disease, diabetes and obesity, were affected severely by the pandemic.

Amendment 452 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Article 3 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) protect people in the Union from (1) support health promotion and serious cross-border threats to health; prevention, reduce health inequalities, improve physical and mental health and protect people in the Union from serious cross-border threats to health;

Or. en

Amendment 453 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim, Sándor Rónai

Proposal for a regulation Article 3 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) protect people in the Union from (1) protect people in the Union from serious cross-border threats to health; serious cross-border threats to health; implement better preparedness and coordination within and between Member States as regards health emergencies;

Or. en

Amendment 454 Frédérique Ries

AM\1207705EN.docx 247/276 PE653.822v01-00 EN Proposal for a regulation Article 3 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) protect people in the Union from (1) support health promotion and serious cross-border threats to health; disease prevention and protect people in the Union from serious cross-border threats to health;

Or. en

Amendment 455 Inese Vaidere

Proposal for a regulation Article 3 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) protect people in the Union from (1) protect people in the Union from serious cross-border threats to health; serious cross-border threats to health and reduce health inequalities among Member States;

Or. en

Amendment 456 Mairead McGuinness

Proposal for a regulation Article 3 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) protect people in the Union from (1) support and foster public health serious cross-border threats to health; and protect people in the Union from serious cross-border threats to health;

Or. en

PE653.822v01-00 248/276 AM\1207705EN.docx EN Amendment 457 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Article 3 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) protect people in the Union from (1) protect people in the Union from serious cross-border threats to health; any serious cross-border threats to health;

Or. en

Amendment 458 Cristian-Silviu Buşoi

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) support existing and future Union Union of medicines, medical devices and health legislation, improve the equal other crisis relevant products, contribute availability, accessibility and affordability to their affordability, and support of health care and services in the Union, innovation; including of medicines, treatments and medical devices, support safe and effective use, and boost research and innovation in healthcare; support systematic health impact assessment of other EU policies ensuring a comprehensive, Health in All Policies approach.

Or. en

Amendment 459 Christian Ehler on behalf of the EPP Group Dan Nica on behalf of the S&D Group Ville Niinistö on behalf of the Greens/EFA Group Marisa Matias

AM\1207705EN.docx 249/276 PE653.822v01-00 EN on behalf of the GUE/NGL Group Cristian-Silviu Buşoi

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) support existing and future Union Union of medicines, medical devices and health legislation, improve the availability other crisis relevant products, contribute and sustainable production capacity of to their affordability, and support medicines, treatments and medical devices innovation; in the Union and to ensure their accessibility and affordability, support safe and effective use, and boost research and innovation in healthcare without duplicating efforts under programmes, including Horizon Europe;

Or. en

Amendment 460 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) support existing and future Union Union of medicines, medical devices and health legislation, improve the availability other crisis relevant products, contribute to in the Union of medicines, vaccines, their affordability, and support innovation; medical devices and other medical relevant products and e-health solutions, contribute to their accessibility, sustainability and affordability, and support research, innovation and development in health and healthcare;

Or. en

Amendment 461 Kateřina Konečná

PE653.822v01-00 250/276 AM\1207705EN.docx EN Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) support existing and future Union Union of medicines, medical devices and health legislation, improve the equal other crisis relevant products, contribute availability, accessibility and affordability to their affordability, and support of health care and services in the Union, innovation; including of medicines, treatments and medical devices, support safe and effective use, and boost research and innovation in healthcare;

Or. en

Justification

Access to healthcare, including medicines, is a fundamental patients’ right. Patients will only benefit from care and services if they are available in a timely manner, accessible and affordable to all who need them. EPF’s principle of equitable access is based on needs not means.

Amendment 462 Joanna Kopcińska

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) support existing and future Union Union of medicines, medical devices and health legislation, improve the availability other crisis relevant products, contribute in the Union of medicines, treatments and to their affordability, and support medical devices, contribute to their innovation; accessibility and affordability, support the safe and effective use of medicines, and advance research in healthcare;

Or. en

Amendment 463 Mick Wallace

AM\1207705EN.docx 251/276 PE653.822v01-00 EN Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) support existing and future Union Union of medicines, medical devices and health legislation, improve the availability other crisis relevant products, contribute to in the Union of medicines, medical devices their affordability, and support innovation; and other relevant products, contribute to their accessibility and affordability, support safe and effective use, and boost research and innovation in healthcare;

Or. en

Justification

The Programme should not be limited to crisis relevant products and should support innovation in care as well as products to the benefit of all patients in the Union in an equitable manner.

Amendment 464 Michèle Rivasi

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) improve the availability in the Union of medicines, medical devices and Union of medicines, treatments and other crisis relevant products, contribute medical devices, contribute to their to their affordability, and support accessibility and affordability, support innovation; their safe and effective use, and boost research and innovation in healthcare with a net benefit for public health;

Or. en

Justification

Innovation is a means, not an objective. Innovation is not good per se - innovation can bring about improvements, but it can also make things worse. It is therefore important to qualify what kind of research and innovation we need - only then can it be included in the general objectives.

PE653.822v01-00 252/276 AM\1207705EN.docx EN Amendment 465 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, María Soraya Rodríguez Ramos

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) restore pharmaceutical Union of medicines, medical devices and independence of the Union to improve other crisis relevant products, contribute to ensure the availability in the Union of their affordability, and support innovation; medicines, vaccines and diagnostic tools, medical devices and other crisis relevant products, contribute to their affordability, and support innovation via the Pharmaceutical Strategy;

Or. en

Amendment 466 Frédérique Ries

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) improve the availability in the Union of medicines, medical devices and Union of medicines, medical devices and other crisis relevant products, contribute to other relevant products contribute to their their affordability, and support innovation; accessibility and affordability, support safe and effective use, and boost research and innovation in healthcare;

Or. en

Amendment 467 Véronique Trillet-Lenoir, Stéphane Bijoux

Proposal for a regulation Article 3 – paragraph 1 – point 2

AM\1207705EN.docx 253/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(2) improve the availability in the (2) improve the availability in the Union of medicines, medical devices and Union, especially in the outermost regions other crisis relevant products, contribute to and the overseas countries and territories, their affordability, and support innovation; of medicines, medical devices and other crisis relevant products, contribute to their affordability, and support innovation;

Or. fr

Amendment 468 Mairead McGuinness

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) improve the availability in the Union of medicines, medical devices and Union of medicines, medical devices and other crisis relevant products, contribute to other crisis relevant products, contribute to their affordability, and support innovation; their accessibility and affordability not only during times of crisis, and support research and innovation;

Or. en

Amendment 469 Mick Wallace, Clare Daly

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) improve the availability in the Union of medicines, medical devices and Union of medicines, medical devices and other crisis relevant products, contribute to other crisis relevant products, including their affordability, and support innovation; products which remain essential in times of crisis, contribute to their affordability, and support innovation;

Or. en

PE653.822v01-00 254/276 AM\1207705EN.docx EN Amendment 470 Bartosz Arłukowicz, Jarosław Duda

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) improve the availability in the Union of medicines, medical devices and Union of medicines, medical devices and other crisis relevant products, contribute to other relevant products, contribute to their their affordability, and support innovation; affordability, promote their safe use, and intensify and support innovation;

Or. pl

Amendment 471 Jessica Polfjärd

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) improve the availability in the Union of medicines, medical devices and Union of medicines, medical devices and other crisis relevant products, contribute to other crisis relevant products, contribute to their affordability, and support innovation; their accessibility and affordability, and support innovation;

Or. en

Amendment 472 Inese Vaidere

Proposal for a regulation Article 3 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) improve the availability in the (2) improve the availability in the Union of medicines, medical devices and Union of medicines, treatment, medical other crisis relevant products, contribute to devices and other crisis relevant products,

AM\1207705EN.docx 255/276 PE653.822v01-00 EN their affordability, and support innovation; contribute to their affordability, and support innovation;

Or. en

Amendment 473 Cristian-Silviu Buşoi

Proposal for a regulation Article 3 – paragraph 1 – point 3

Text proposed by the Commission Amendment

(3) strengthen health systems and the (3) strengthen health systems and the healthcare workforce, including by digital healthcare workforce, including by digital transformation and by increased integrated transformation, harmonized education and and coordinated work among the Member training and by increased integrated and States, sustained implementation of best coordinated work among the Member practice and data sharing, to increase the States, sustained implementation of best general level of public health. practices, health literacy, joint health targets, metrics and patients, and comparable data sharing, to increase the general level of public health.

Or. en

Amendment 474 Jessica Polfjärd

Proposal for a regulation Article 3 – paragraph 1 – point 3

Text proposed by the Commission Amendment

(3) strengthen health systems and the (3) strengthen health systems and make healthcare workforce, including by digital them more resilient and responsive to transformation and by increased integrated crises, including by digital transformation and coordinated work among the Member and by increased coordinated work among States, sustained implementation of best the Member States, sustained practice and data sharing, to increase the implementation of best practice and data general level of public health. sharing, in order to increase the general level of public health.

Or. en

PE653.822v01-00 256/276 AM\1207705EN.docx EN Amendment 475 Kateřina Konečná

Proposal for a regulation Article 3 – paragraph 1 – point 3

Text proposed by the Commission Amendment

(3) strengthen health systems and the (3) strengthen health systems and the healthcare workforce, including by digital healthcare workforce, including by digital transformation and by increased integrated transformation, harmonized education and and coordinated work among the Member training, and by increased integrated and States, sustained implementation of best coordinated work among the Member practice and data sharing, to increase the States, sustained implementation of best general level of public health. Practice, improvement of health literacy for citizens and patients and comparable data sharing, to increase the general level of public health.

Or. en

Amendment 476 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Sándor Rónai

Proposal for a regulation Article 3 – paragraph 1 – point 3

Text proposed by the Commission Amendment

(3) strengthen health systems and the (3) strengthen health systems and the healthcare workforce, including by digital healthcare workforce, including by digital transformation and by increased integrated and green transformation, and by and coordinated work among the Member increased integrated and coordinated work States, sustained implementation of best among the Member States, sustained practice and data sharing, to increase the implementation of best practice and general level of public health. comparable data sharing, to increase the general level of public health and health literacy of the population.

Or. en

AM\1207705EN.docx 257/276 PE653.822v01-00 EN Amendment 477 Michèle Rivasi

Proposal for a regulation Article 3 – paragraph 1 – point 3

Text proposed by the Commission Amendment

(3) strengthen health systems and the (3) strengthen health systems, their healthcare workforce, including by digital sustainability and the healthcare transformation and by increased integrated workforce, including by digital and coordinated work among the Member transformation that fully respects the States, sustained implementation of best European data protection framework, practice and data sharing, to increase the harmonized education and training, and general level of public health. by increased integrated and coordinated work among the Member States, sustained implementation of best practice and comparable data sharing, to increase the general level of public health.

Or. en

Justification

We also need to strengthen the sustainability of health systems. It is of paramount importance that the digital transformation fully respects the European data protection framework (see paragraph 33 of the European Parliament Resolution of 10 July 2020 on EU public health strategy post COVID-19).

Amendment 478 Mick Wallace, Clare Daly

Proposal for a regulation Article 3 – paragraph 1 – point 3

Text proposed by the Commission Amendment

(3) strengthen health systems and the (3) strengthen health systems and the healthcare workforce, including by digital healthcare workforce, including by digital transformation and by increased integrated transformation of all health care services and coordinated work among the Member and procedures, and by increased States, sustained implementation of best integrated and coordinated work among the practice and data sharing, to increase the Member States, sustained implementation general level of public health. of best practice and data sharing, to increase the general level of public health.

Or. en

PE653.822v01-00 258/276 AM\1207705EN.docx EN Amendment 479 Pascal Arimont, Cindy Franssen, Esther de Lange

Proposal for a regulation Article 3 – paragraph 1 – point 3

Text proposed by the Commission Amendment

(3) strengthen health systems and the (3) strengthen health systems and the healthcare workforce, including by digital healthcare workforce, including by digital transformation and by increased integrated transformation and by increased integrated and coordinated work among the Member and coordinated work among the Member States, sustained implementation of best States at national, regional and local practice and data sharing, to increase the level, sustained implementation of best general level of public health. practice and data sharing, to increase the general level of public health.

Or. en

Amendment 480 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Article 3 – paragraph 1 – point 3

Text proposed by the Commission Amendment

(3) strengthen health systems and the (3) strengthen health systems and the healthcare workforce, including by digital healthcare workforce, including by digital transformation and by increased integrated transformation harmonized education and and coordinated work among the Member training and by increased integrated and States, sustained implementation of best coordinated work among the Member practice and data sharing, to increase the States, sustained implementation of best general level of public health. practice and data sharing, to increase the general level of public health.

Or. en

Amendment 481 Christian Ehler on behalf of the EPP Group Dan Nica on behalf of the S&D Group

AM\1207705EN.docx 259/276 PE653.822v01-00 EN Martina Dlabajová on behalf of the Renew Group Cristian-Silviu Buşoi

Proposal for a regulation Article 3 – paragraph 1 – point 3

Text proposed by the Commission Amendment

(3) strengthen health systems and the (3) strengthen health systems and the healthcare workforce, including by digital healthcare workforce, including by digital transformation and by increased integrated transformation and by increased integrated and coordinated work among the Member and coordinated work among the Member States, sustained implementation of best States, sustained implementation of best practice and data sharing, to increase the practice and comparable and general level of public health. interoperable data sharing, to increase the general level of public health.

Or. en

Amendment 482 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Article 3 – paragraph 1 – point 3

Text proposed by the Commission Amendment

(3) strengthen health systems and the (3) strengthen health systems and the healthcare workforce, including by digital healthcare workforce, including by digital transformation and by increased integrated transformation and by increased integrated and coordinated work among the Member and coordinated work among the Member States, sustained implementation of best States, sustained implementation of best practice and data sharing, to increase the practice and data sharing, to ensure general level of public health. interoperablity of their actions and increase the general level of public health.

Or. en

Amendment 483 Marian-Jean Marinescu

PE653.822v01-00 260/276 AM\1207705EN.docx EN Proposal for a regulation Article 3 – paragraph 1 – point 3

Text proposed by the Commission Amendment

(3) strengthen health systems and the (3) strengthen health systems, heath healthcare workforce, including by digital infrastructure and the healthcare transformation and by increased integrated workforce, including by digital and coordinated work among the Member transformation and by increased integrated States, sustained implementation of best and coordinated work among the Member practice and data sharing, to increase the States, sustained implementation of best general level of public health. practice and data sharing, to increase the general level of public health.

Or. en

Amendment 484 Nathalie Colin-Oesterlé

Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new)

Text proposed by the Commission Amendment

(3a) support and strengthen existing and future EU health legislation to improve the availability in the EU of medicines, medical devices and other products that are required in case of shortages, and contribute to their accessibility and affordability;

Or. fr

Amendment 485 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, María Soraya Rodríguez Ramos

Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new)

Text proposed by the Commission Amendment

(3a) reduce health inequalities between

AM\1207705EN.docx 261/276 PE653.822v01-00 EN Member States and within Member States while taking into account the “health in all policies” approach;

Or. en

Amendment 486 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim

Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new)

Text proposed by the Commission Amendment

(3a) support systematic health impact assessment of other EU policies ensuring a comprehensive, Health in All Policies approach;

Or. en

Amendment 487 Marian-Jean Marinescu

Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new)

Text proposed by the Commission Amendment

(3a) support action aimed to provide equal access to health care, innovative medical treatment, medicines and medical devices;

Or. en

Amendment 488 Michèle Rivasi

Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new)

PE653.822v01-00 262/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(3a) support actions on integrative, person-centred and outcome-based care and health systems;

Or. en

Amendment 489 Piernicola Pedicini, Eleonora Evi

Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new)

Text proposed by the Commission Amendment

(3a) contribute to disease prevention by addressing key environmental risk factors;

Or. en

Amendment 490 Aldo Patriciello

Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new)

Text proposed by the Commission Amendment

(3a) make health systems become resilient and better respond to health crises;

Or. en

Amendment 491 Jessica Polfjärd

Proposal for a regulation Article 3 – paragraph 1 – point 3 a (new)

AM\1207705EN.docx 263/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(3a) support the prevention of communicable diseases within the Union;

Or. en

Amendment 492 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Article 3 – paragraph 1 – point 3 b (new)

Text proposed by the Commission Amendment

(3b) support health promotion, health protection and disease prevention, reduce health inequalities and inequities, improve physical and mental health, addressing in particular the key lifestyle related risk factors with a focus on the Union added value and scale up to healthier and more resilient societies;

Or. en

Amendment 493 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Article 3 – paragraph 1 – point 3 b (new)

Text proposed by the Commission Amendment

(3b) provide integrated healthcare, accessible at local or regional level, enabling patients to be better supported in their own local and social environment;

Or. en

PE653.822v01-00 264/276 AM\1207705EN.docx EN Amendment 494 Rob Rooken

Proposal for a regulation Article 4 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

The general objectives referred to in The general objectives referred to in Article 3 shall be pursued through the Article 3 shall be pursued through the following specific objectives, in keeping following specific objectives, pending the with the ‘One Health’ approach where outcomes of independent, science-based relevant: impact assessments:

Or. nl

Amendment 495 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Article 4 – paragraph 1 – introductory part

Text proposed by the Commission Amendment

The general objectives referred to in The general objectives referred to in Article 3 shall be pursued through the Article 3 shall be pursued through the following specific objectives, in keeping following specific objectives, in keeping with the “One Health” approach where with the “One Health” and “Health in all relevant: policies” approaches where relevant:

Or. en

Amendment 496 Michèle Rivasi

Proposal for a regulation Article 4 – paragraph 1 – point -1 (new)

Text proposed by the Commission Amendment

(-1) address key lifestyle risk factors as

AM\1207705EN.docx 265/276 PE653.822v01-00 EN well as environmental risk factors and improve physical and mental health;

Or. en

(Linked to the amendment by the same author to Article 3(1)(-1a).)

Justification

This specific objective is inserted as a new first specific objective to reflect the element of health promotion and disease prevention of the newly introduced first general objective by the same author. Moreover, addressing key lifestyle risks is explicitly listed in the first specific objective of the current programme and should also be listed here as the first specific objective. While there have been many fatalities due to COVID-19, there are many many more due to key lifestyle risk and environmental risks. The first specific objective should therefore take a broad approach to public health before cross-border health threats and crisis-related aspects.

Amendment 497 Michèle Rivasi

Proposal for a regulation Article 4 – paragraph 1 – point -1 a (new)

Text proposed by the Commission Amendment

(-1a) implement the right to timely access to affordable, preventive and curative health care of good quality, and promote the use of health equity impact assessments of all relevant policies;

Or. en

(Linked to the amendment by the same author to Article 3(1)(-1a).)

Justification

This specific objective is inserted as a new specific objective at the beginning of the specific objectives to reflect the element of reducing health inequalities in the newly introduced first general objective by the same author. The second specific objective should take a broad approach to public health before cross-border health threats and crisis-related aspects. The right to timely access to affordable, preventive and curative health care of good quality is Principle 16 of the European Pillar of Social Rights.

PE653.822v01-00 266/276 AM\1207705EN.docx EN Amendment 498 Michèle Rivasi

Proposal for a regulation Article 4 – paragraph 1 – point -1 b (new)

Text proposed by the Commission Amendment

(-1b) support implementation of the zero pollution ambition for a toxic-free environment;

Or. en

Amendment 499 Traian Băsescu

Proposal for a regulation Article 4 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) strengthen the capability of the (1) strengthen the capability of the Union for prevention, preparedness and Union for prevention, preparedness and response to serious cross-border threats to response to serious cross-border threats to health, and the management of health health, and the management of health crises, including through coordination, crises, including through coordination, provision and deployment of emergency provision and deployment of emergency health care capacity, data gathering and health care capacity, data gathering and surveillance; surveillance, including by enhancing the capacity of all of the Member States’ health systems to quickly build autonomous mobile hospitals that can treat affected patients near infection hotspots;

Or. ro

Amendment 500 Joanna Kopcińska

Proposal for a regulation Article 4 – paragraph 1 – point 1

AM\1207705EN.docx 267/276 PE653.822v01-00 EN Text proposed by the Commission Amendment

(1) strengthen the capability of the (1) in full accordance with Article Union for prevention, preparedness and 168(5) of the Treaty on the Functioning response to serious cross-border threats to of the European Union, strengthen the health, and the management of health capability of the Union, including the crises, including through coordination, EMA and the ECDC, for prevention, provision and deployment of emergency preparedness and response to serious cross- health care capacity, data gathering and border threats to health, and the surveillance; management of health crises, including through coordination, provision and deployment of emergency health care capacity, data gathering and surveillance;

Or. en

Amendment 501 Michèle Rivasi

Proposal for a regulation Article 4 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) strengthen the capability of the (1) strengthen the capability of the Union for prevention, preparedness and Union for prevention, preparedness and response to serious cross-border threats to response to serious cross-border threats to health, and the management of health health, and the management of health crises, including through coordination, crises, including through coordination, provision and deployment of emergency provision and deployment of emergency health care capacity, data gathering and health care capacity, data gathering and surveillance; surveillance, and the coordination of stress testing of national healthcare systems;

Or. en

Justification

It is of crucial importance that stress tests are conducted of national health systems. Such stress tests were called for by the European Parliament in its resolution on the EU public health strategy post COVID-19 of 10 July 2020 (see paragraph 9).

PE653.822v01-00 268/276 AM\1207705EN.docx EN Amendment 502 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel, Mohammed Chahim, Sándor Rónai

Proposal for a regulation Article 4 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) strengthen the capability of the (1) strengthen the capability of the Union for prevention, preparedness and Union for prevention, preparedness and response to serious cross-border threats to response to serious cross-border threats to health, and the management of health health, and the management of health crises, including through coordination, crises, including through coordination, provision and deployment of emergency provision and deployment of emergency health care capacity, data gathering and health care capacity, data gathering, surveillance; surveillance and health risk assessment;

Or. en

Amendment 503 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Article 4 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) strengthen the capability of the (1) strengthen the capability of the Union for prevention, preparedness and Union for prevention, preparedness and response to serious cross-border threats to response to serious cross-border threats to health, and the management of health health, and the management of health crises, including through coordination, crises, including through organization of provision and deployment of emergency stress tests, coordination, provision and health care capacity, data gathering and deployment of emergency health care surveillance; capacity, data gathering and surveillance;

Or. en

Amendment 504 Margarita de la Pisa Carrión

AM\1207705EN.docx 269/276 PE653.822v01-00 EN Proposal for a regulation Article 4 – paragraph 1 – point 1

Text proposed by the Commission Amendment

(1) strengthen the capability of the (1) strengthen the capability of the Union for prevention, preparedness and Union for prevention, preparedness and response to serious cross-border threats to rapid response to serious cross-border health, and the management of health threats to health, and the management of crises, including through coordination, health crises, including through provision and deployment of emergency coordination, provision and deployment of health care capacity, data gathering and emergency health care capacity, data surveillance; gathering and surveillance;

Or. es

Amendment 505 Cristian-Silviu Buşoi

Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new)

Text proposed by the Commission Amendment

(1a) support actions aimed at creating and developing a EU Platform for shortages, based on one harmonised data- collection model and national reporting systems of shortages interoperability, including the full implementation of an effective EU telematics infrastructure that will link data on medicine and supply chain data through interconnection of SPOR and FMD system;

Or. en

Amendment 506 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, Andreas Glück, María Soraya Rodríguez Ramos

Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new)

PE653.822v01-00 270/276 AM\1207705EN.docx EN Text proposed by the Commission Amendment

(1a) Support the strengthening of the competences and resources of the European health agencies namely the ECDC and the EMA, the European Food Safety Authority (EFSA), European Chemicals Agency (ECHA) and EU- OSHA;

Or. en

Amendment 507 Adam Jarubas

Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new)

Text proposed by the Commission Amendment

(1a) create and develop a EU Platform for shortages, based on one harmonised data-collection model and national reporting systems of shortages interoperability, including the full implementation of an effective EU telematics infrastructure that will link data on medicine and supply chain data through interconnection of SPOR and FMD system;

Or. en

Amendment 508 Nathalie Colin-Oesterlé

Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new)

Text proposed by the Commission Amendment

(1a) support the creation, development and implementation of a strategy to tackle shortages of medicines and medical

AM\1207705EN.docx 271/276 PE653.822v01-00 EN devices in order to ensure all patients in the European Union are able to access treatment;

Or. fr

Amendment 509 Danilo Oscar Lancini

Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new)

Text proposed by the Commission Amendment

(1a) support actions aimed at modernise and digitalise the EU regulatory Network at European and national level;

Or. en

Amendment 510 Margarita de la Pisa Carrión

Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new)

Text proposed by the Commission Amendment

(1a) promote online medical and health education in general;

Or. es

Amendment 511 Cristian-Silviu Buşoi

Proposal for a regulation Article 4 – paragraph 1 – point 1 b (new)

Text proposed by the Commission Amendment

(1b) support actions aimed at

PE653.822v01-00 272/276 AM\1207705EN.docx EN modernise and digitalise the EU regulatory Network at European and national level;

Or. en

Amendment 512 Adam Jarubas

Proposal for a regulation Article 4 – paragraph 1 – point 1 b (new)

Text proposed by the Commission Amendment

(1b) modernise and digitalise the EU regulatory Network at European and national level;

Or. en

Amendment 513 Nicolae Ştefănuță, Véronique Trillet-Lenoir

Proposal for a regulation Article 4 – paragraph 1 – point 1 a (new)

Text proposed by the Commission Amendment

(1a) The objectives of Article 4 shall be delivered in a consistent and transparent way and in a manner that is coordinated with the actions of other Union programmes and agencies.

Or. en

Amendment 514 Christian Ehler on behalf of the EPP Group Dan Nica on behalf of the S&D Group Martina Dlabajová on behalf of the Renew Group

AM\1207705EN.docx 273/276 PE653.822v01-00 EN Ville Niinistö on behalf of the Greens/EFA Group Marisa Matias on behalf of the GUE/NGL Group Cristian-Silviu Buşoi

Proposal for a regulation Article 4 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) ensure the availability in the Union (2) ensure the availability in the Union of reserves or stockpiles of crisis relevant of reserves of crisis relevant products, and products, and a reserve of medical, a reserve of medical, healthcare and healthcare and support staff to be support staff to be mobilised in case of a mobilised in case of a crisis; crisis or shortage, ensure that such a reserve is available for fair access by all Member States in the Union;

Or. en

Amendment 515 Sara Cerdas, Tudor Ciuhodaru, César Luena, Rovana Plumb, Milan Brglez, Javi López, Łukasz Kohut, Petar Vitanov, István Ujhelyi, Monika Beňová, Miroslav Číž, Robert Hajšel

Proposal for a regulation Article 4 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) ensure the availability in the Union (2) ensure the availability in the Union of reserves or stockpiles of crisis relevant of reserves or stockpiles of medical products, and a reserve of medical, relevant products, and a reserve of medical, healthcare and support staff to be healthcare and support staff to be mobilised in case of a crisis; mobilised in case of a crisis, improving the training of health professionals and updating their knowledge;

Or. en

Amendment 516 Margarita de la Pisa Carrión

PE653.822v01-00 274/276 AM\1207705EN.docx EN Proposal for a regulation Article 4 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) ensure the availability in the Union (2) ensure the availability in the Union of reserves or stockpiles of crisis relevant of reserves or stockpiles of crisis relevant products, and a reserve of medical, products, as well as production capacity, healthcare and support staff to be and a reserve of medical, healthcare and mobilised in case of a crisis; support staff to be mobilised in case of a crisis;

Or. es

Amendment 517 Véronique Trillet-Lenoir, Nicolae Ştefănuță, Irena Joveva, Sylvie Brunet, Nathalie Loiseau, Bernard Guetta, Stéphanie Yon-Courtin, Ilana Cicurel, Fabienne Keller, Susana Solís Pérez, María Soraya Rodríguez Ramos

Proposal for a regulation Article 4 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) ensure the availability in the Union (2) ensure the availability in the Union of reserves or stockpiles of crisis relevant of reserves or stockpiles of crisis relevant products, and a reserve of medical, products, and a reserve of medical, healthcare and support staff to be healthcare and support staff to be mobilised in case of a crisis; mobilised in case of a crisis such as the European Medical Corps;

Or. en

Amendment 518 Jessica Polfjärd

Proposal for a regulation Article 4 – paragraph 1 – point 2

Text proposed by the Commission Amendment

(2) ensure the availability in the Union (2) ensure the availability in the Union of reserves or stockpiles of crisis relevant of reserves of crisis relevant products, and products, and a reserve of medical, a reserve of medical, healthcare and healthcare and support staff to be support staff to be mobilised in case of a

AM\1207705EN.docx 275/276 PE653.822v01-00 EN mobilised in case of a crisis; crisis;

Or. en

Amendment 519 Nathalie Colin-Oesterlé

Proposal for a regulation Article 4 – paragraph 1 – point 2 a (new)

Text proposed by the Commission Amendment

(2a) support the creation, development and implementation of a strategy on health personnel in order to ensure an effective public health workforce, with the same high standards across the Union, and promote the excellence of medical and healthcare professionals; to this end, simplify the rules to allow cross-border health workers effective mobility, particularly in the event of a crisis or pandemic;

Or. fr

PE653.822v01-00 276/276 AM\1207705EN.docx EN