136 Amendments of Nicolae ŞTEFĂNUȚĂ related to 2020/0102(COD)
Amendment 119 #
Proposal for a regulation
Recital 3 a (new)
Recital 3 a (new)
(3a) In its communication of 20 October 2010 entitled ‘Solidarity in Health: Reducing Health Inequalities in the EU’, the Commission considered that there is a social gradient in health status in all the EU Member States. The World Health Organisation defines this social gradient as being the link between socioeconomic inequalities and inequalities in the areas of health and access to healthcare.
Amendment 120 #
Proposal for a regulation
Recital 3 b (new)
Recital 3 b (new)
(3b) Health inequalities are rooted in social inequalities in terms of living conditions and models of social behaviour linked to gender, race, educational standards, employment, income and the unequal distribution of access to medical assistance, sickness prevention and health promotion services. The programme should facilitate the establishment of a common set of health determinants to monitor health inequalities by age, sex, socio-economic status and geographic location and introduce a methodology for auditing the health situation in Member States with the aim of identifying and prioritising areas in need of improvement and increased fundings. In its annual implementation assessment report, the Commission should evaluate the effectiveness of measures to reduce health inequalities resulting from policies relating to the social, economic and environmental risk factors. Through the allocation of fundings to the relevant regional and local stakeholders, the Programme should support a ‘local care approach’ to provide integrated healthcare, accessible at local or regional level, enabling patients to be better supported in their own local and social environment. The programme could also facilitate partnerships between border regions in order to share the cost of infrastructure and personnel and reduce inequalities with regard to health, particularly in respect of access to state- of-the-art equipment. The programme should therefore be implemented in close links with EU cohesion policy and structural funds.
Amendment 127 #
Proposal for a regulation
Recital 5
Recital 5
(5) On 11 March 2020 the World Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a global pandemic. That pandemic has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering, particularly affecting people with chronic conditions and hitting the most vulnerable, patients, women, carers and the elderly the hardest.
Amendment 130 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) According to the definition of the World Health Organisation (WHO), "Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." At this stage, the Union has not yet adopted a common definition of health. Following the COVID-19crisis. The Commission should propose a broader definition of the “public health” at European level.
Amendment 131 #
Proposal for a regulation
Recital 5 b (new)
Recital 5 b (new)
Amendment 140 #
Proposal for a regulation
Recital 6
Recital 6
(6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States in order to improve the prevention and control of the spread of severe human diseases across borders, to 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 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, COM(2020)112 final of 13.03.220.
Amendment 149 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) While the Union´s action in the field of health is limited, the Union shall follow a coherent public health strategy in order face future worrying realities and health threats, such as pandemics and cross-border threats, including antimicrobial resistance and the health impacts of the climate crisis. The Union shall support Member States in reducing health inequalities and in achieving universal health coverage, addressing the challenges of an ageing population, of chronic diseases, or disease prevention, in promoting a healthy lifestyle, equal from a sex, gender and perspective to health and prevention services and preparing their health systems for emerging technologies.
Amendment 158 #
Proposal for a regulation
Recital 7
Recital 7
(7) It is therefore appropriate to establish a new Programme for the Union's action in the field of public health, called EU4Health Programme ('the Programme') for the period 2021 -2027. In line with the goals of the Union action and its competences in the area of public health the Programme should place emphasis on actions in relation to which there are advantages and efficiency gains from collaboration and cooperation at Union level and actions with an impact on the internal market.
Amendment 161 #
Proposal for a regulation
Recital 9
Recital 9
(9) In accordance with Regulation [European Union Recovery Instrument] and within the limits of resources allocated therein, recovery and resilience measures under the Programme should be carried out to address the unprecedented impact of the COVID-19 crisis and ensure that resilient and responsive healthcare and public health systems are in place in preparation for future pandemics and other cross- 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].
Amendment 164 #
Proposal for a regulation
Recital 10
Recital 10
(10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage healthany future sanitary crisises, the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. Thise revision of Decision No 1082/2013/EU could includitiate strategic stockpiling of essential medical supplies, in addition to the reactive reserve created under RescEU during the Covid-19 pandemic, or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. This revision could also introduce the creation of a European Health Response Mechanism to respond to all types of health crises (infectious, chemical, environmental, biological, food, nuclear), to strengthen operational coordination at European level and to monitor the constitution and the 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. __________________ 10Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 170 #
Proposal for a regulation
Recital 10
Recital 10
(10) Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include strategic stockpiling of essential medical supplies in addition to the reactive reserve created under rescEU during the Covid-19 pandemic or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management and response capacity of actors at the Union, national, regional and local level, including contingency planning and preparedness exercises, in keeping with the “One Health” approach. It should facilitate the setting up of an integrated cross-cutting risk communication framework working in all phases of a health crisis - prevention, preparedness and response. __________________ 10Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
Amendment 183 #
Proposal for a regulation
Recital 11
Recital 11
(11) As in the time of health crisis emergency health technology assessment as well as clinical trials can contribute to the rapid development of medical countermeasures the Programme should provide support to facilitate such actions. The Commission has adopted a proposal11 on Health Technology Assessment (HTA)TA to support cooperation on health technology assessment at Union level. The Council should adopt a common position and start the negotiations with the Parliament on this proposal. __________________ 11Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU, COM(2018) 51 final of 31.01. 2018.
Amendment 190 #
Proposal for a regulation
Recital 12
Recital 12
(12) With a view to protect people in vulnerable situations, including those suffering from mental illnesses and chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups. With a view to guaranteeing continued high standards of essential healthcare services, the Programme should, in particular in times of crisis and pandemics, encourage a transition to accessible and affordable telemedicine, at- home administration of medication and implementation of preventative and self- care plans, where possible and appropriate, while ensuring that access to healthcare and prevention services is provided to chronic patients and patients at risk.
Amendment 193 #
Proposal for a regulation
Recital 12
Recital 12
(12) With a view to protect people in vulnerable situpopulations, including those suffering from mental illnesses andchildren, the elderly, pregnant women, people affected by a disability, patients with chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis and medical products shortages on people belonging to such vulnerable groups.
Amendment 198 #
Proposal for a regulation
Recital 13
Recital 13
(13) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices as well as personal protective equipment needed in the Union during the pandemics. The Programme therefore should provide support to actions which foster the production, procurement and, management and distribution of crisis relevant products ensuring complementarity with other 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.
Amendment 207 #
Proposal for a regulation
Recital 14
Recital 14
(14) In order to minimise the public health consequences of serious cross- border threats to health it should be possible for actions supported under the Programme to cover coordination of the activities which strengthen the interoperability and coherence of Member States’ health-systems through benchmarking, cooperation and exchange of best practices via an increased number of Joint Actions and ensure their capability to respond to health emergencies, that includes contingency planning, preparedness exercises and the upskilling of health care and public health staff and the establishment of mechanisms for the efficient monitoring and needs-driven distribution or allocation of goods and services needed in time of crisis.
Amendment 209 #
Proposal for a regulation
Recital 14 a (new)
Recital 14 a (new)
(14a) The COVID-19 crisis has revealed the important need for Member States to organize stress tests to assess the resilience of their national health systems to all types of crises. These tests must be carried out on the basis of precise evaluation criteria set by the European Commission. The results of these tests could determine the weaknesses of the national health systems and the areas to be the subject to specific financial support.
Amendment 210 #
Proposal for a regulation
Recital 14 b (new)
Recital 14 b (new)
(14b) The coordination between national health systems is essential to guarantee solidarity within the Union. Joint procurement, coordinated transfer of equipment, reserve and circulation of blood products and organs, transports of patients for cross-border care should be adequately anticipated.
Amendment 211 #
Proposal for a regulation
Recital 14 c (new)
Recital 14 c (new)
(14c) In addition to an increased budget, the EU Civil Protection Mechanism (UCPM) and its instrument RescEU should be strengthened to ensure a truly common, coordinated and effective response at EU level.
Amendment 212 #
Proposal for a regulation
Recital 14 d (new)
Recital 14 d (new)
(14d) The Union should be able to rely on the mobilization of health professionals through the “European Medical Corps” created to enable quick medical assistance and public health expertise to all Member States.
Amendment 213 #
Proposal for a regulation
Recital 14 e (new)
Recital 14 e (new)
(14e) European health agencies, in particular the ECDC and the EMA should be granted strengthened competences, resources and personnel to allow them to better and quicker carry out their duties efficiently to the benefit of European citizens. To anticipate any types of crises, the Commission should also evaluate the needs of the other European health agencies such as EFSA, ECHA and EU- OSHA. A stronger coordination between European Agencies should be guaranteed by the Commission.
Amendment 214 #
Proposal for a regulation
Recital 14 f (new)
Recital 14 f (new)
(14f) The Programme should support the revision of ECDC’s mandate to extend its competencies to the chronical diseases, to elaborate mandatory guidances for Member States and to be able to coordinate laboratory research in times of health crises.
Amendment 215 #
Proposal for a regulation
Recital 14 g (new)
Recital 14 g (new)
(14g) The programme should also support the revision of the EMA’s mandate to extend its competencies on clinical trial’s coordination and management of the shortages of medicines. EMA could therefore meet any future challenges such as monitoring and responding to shortages in coordination with the Member States. In the long term, EMA should be able to make conditional marketing authorizations upon guarantees of supply and accessibility from manufacturers. The reinforcement of the EMA’s personnel should enable the Agency to carry out inspections of production sites established in third countries.
Amendment 216 #
Proposal for a regulation
Recital 14 h (new)
Recital 14 h (new)
(14h) In order to facilitate EU Joint Procurement procedures, the Commission could adopt a specific legislation to promote their use to buy vaccines and treatments, to guarantee the efficiency and the transparency of the process and to ensure an equal access to medicines, medical devices, protective equipment and other relevant health products. A part of the medical products purchased via the EU joint procurement procedure could constitute a European contingency reserve of medical products subjected to shortages.
Amendment 217 #
Proposal for a regulation
Recital 14 i (new)
Recital 14 i (new)
(14i) The establishment of a communication portal for the public would allow the Union to share validated information, send alerts to European citizens and fight against disinformation. It could include a wide range of information, prevention campaigns and youth education programs. This portal could also be used to promote, in cooperation with the ECDC, a strong immunization coverage at European level.
Amendment 218 #
Proposal for a regulation
Recital 14 j (new)
Recital 14 j (new)
(14j) A digital exchange platform, such as the COVID-19 Data Portal, could facilitate exchanges on epidemiological data, science-based practice recommendations to health professionals and hospitals, and the exact state of mobilizable capacities and medical products stocks.
Amendment 226 #
Proposal for a regulation
Recital 15
Recital 15
(15) Experience from the COVID-19 crisis has indicated that there is a general need for the support to structural transformation of and systemic reforms of health systems across the Union to improve their effectiveness, accessibility and resilience. In the context of such transformation and reforms, the Programme should promote, in synergy with the Digital Europe Programme, actions which advance digital transformation of health services and increase their interoperability, contribute to the increased capacity of health systems to foster disease prevention and health promotion, to provide new care models and to deliver integrated services, from the community and primary health care to the highly specialised services, based on people's needs and ensure an efficient public health workforce equipped with the right skills, including digital skills. The development of a European health data space and of a European Electronic Health Record would provide health care systems, researchers and public authorities with means to improve the accessibility, availability, affordability 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. __________________ 12Council Conclusions on Common values and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1).
Amendment 231 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) The programme should support innovations in the digitalization area that could bring concrete benefits to patients and healthcare professionals and provide cost-effective high-quality healthcare whilst reducing inequalities. Important steps could be taken in digital skills, both for healthcare professionals and patients training, especially in rural and sparsely populated areas.
Amendment 234 #
Proposal for a regulation
Recital 15 b (new)
Recital 15 b (new)
(15b) The programme should facilitate the reinforcement of e-health and m- health as well as the use of telemedicine and remote monitoring of patients, especially in times of sanitary crises.
Amendment 250 #
Proposal for a regulation
Recital 17
Recital 17
(17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors and commercial determinant of health. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes, represent major causes of disability, ill-health, health- related retirement, and premature death in the Union, resulting in considerable social and economic impacts. To decrease the impact of non-communicable diseases on individuals and society in the Union and reach goal 3 of the Sustainable Development Goals, Target 3.4, to reduce premature mortality from non- communicable diseases by one third by 2030, it is key to provide an integrated response focusing on prevention across sectors and policy fields, promotion of a healthy lifestyle combined with efforts to strengthen health systems.
Amendment 257 #
Proposal for a regulation
Recital 17
Recital 17
(17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes, represent major causes of disability, ill-health, health- related retirement, and premature death in the Union, resulting in considerable affective, social and economic impacts. To decrease the impact of non-communicable diseases on individuals and society in the Union and reach goal 3 of the Sustainable Development Goals, Target 3.4, to reduce premature mortality from non- communicable diseases by one third by 2030, it is key to provide an integrated response focusing on prevention across sectors and policy fields, combined with efforts to strengthen health systems.
Amendment 262 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) The role of primary prevention and health promotion is key to address long term, common European challenges such as non-communicable and communicable diseases, ageing and cross- border health threats such as future pandemics, antimicrobial resistance. The Union can bring additional added-value to offer an overall public health strategy based on identified best practices and the European dimension of identified health challenges in the area of access to healthcare, health prevention and promotion in order to reduce health inequalities and health differences in Europe.
Amendment 275 #
Proposal for a regulation
Recital 18
Recital 18
(18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, abuse and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage, unhealthy dietary habits via the adoption of a mandatory harmonized nutrition label such as the Nutri-Score and physical inactivity, and exposure to environmental pollution, and foster supportive environments for healthy lifestyles in order to complement Member States action in these areas. The Programme should also therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and, the Biodiversity Strategy and Chemicals Strategy for Sustainability.
Amendment 281 #
Proposal for a regulation
Recital 18
Recital 18
(18) The Programme thereforeHealth promotion and health prevention are vastly more cost-efficient than treatment, both in terms of money and of quality-adjusted life years, therefore the program should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage, unhealthy dietary habits and physical inactivity, and exposure to environmental pollution, and foster supportive environments for healthy lifestyles in order to complement Member States action in these areas. The Programme should also therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.
Amendment 290 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) The Programme should continue supporting actions in the area of reducing and preventing alcohol related harm in the perspective of a revised EU alcohol strategy. Protecting children from alcohol commercial communication as well as product placement and sponsorship of alcohol brands, especially in the online environment, should be one of the Programme’s priorities.
Amendment 294 #
Proposal for a regulation
Recital 18 b (new)
Recital 18 b (new)
(18b) Vaccination prevents an estimated 2,5 million deaths each year worldwide and reduces disease-specific treatment costs. The introduction of large-scale protective vaccinations in Europe has significantly contributed to the eradication or decline of many infectious diseases. Nevertheless, the worrying phenomenon of vaccine hesitancy and the disinformation on vaccination should be addressed by the Programme to reassure European citizens.
Amendment 296 #
Proposal for a regulation
Recital 19
Recital 19
(19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. Cancer is caused by many factors in multiple stages and therefore requires a new prevention paradigm that addresses individual health determinants (genetic, lifestyle) and wider (populations) determinants related to occupational, environmental and social exposure factors; It is also one of non- communicable diseases that share common risk factors with others and the prevention and control of which would benefit the majority of citizens. Poor nutrition, physical inactivity, obesity, tobacco and alcohol are risk factors common to other chronic diseases, such as cardiovascular diseases, type 2 diabetes, and respiratory diseases, and therefore cancer prevention programmes should be conducted within the context of an integrated chronic disease prevention programme. In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover the entire cyclevery key stage of the disease starting from prevention and early diagnosis to tre:prevention, diagnosis, treatment, life as a cancer survivor, reinsertion and palliative care. The programme should promote actions to improve cancer patmient and quality of life of patients and survivorss' 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.
Amendment 328 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) The programme should encompass a “Health in all policies” and “Health in all fundings” approaches in its implementation and evaluation. In the programme’s framework, the Commission should proceed to a systematic health impact assessment, built on cross-sectorial indicators, of all EU policies and fundings in order to evaluate their impact on improving health and well-being of our citizens.
Amendment 330 #
Proposal for a regulation
Recital 20 b (new)
Recital 20 b (new)
(20b) The programme should guarantee a strong involvement of the civil society (in particular patients' associations) and academics (in particular healthcare professionals' societies) to ensure a balanced representation and participation in achieving public health goals. European health organizations should contribute to the implementation and the evaluation of the programme.
Amendment 331 #
Proposal for a regulation
Recital 20 c (new)
Recital 20 c (new)
(20c) The evaluations of the last and current programmes should be taken into consideration in the framework of the Conference on the Future of Europe, which could come forward with clear proposals to strengthen the European Health Policy.
Amendment 335 #
Proposal for a regulation
Recital 21
Recital 21
(21) In accordance with Article 114 TFEU, a high level of health protection should be ensured in the legislation adopted by the Union for the establishment and the functioning of the internal market. On the basis of Article 114 TFEU and point (c) of Article 168(4) TFEU, a considerable body of Union acquis was developed which guarantees the high standards of quality and safety for medicinal products and medical devices. Given the rising healthcare demand, Member States’ healthcare systems face challenges in the availability and affordability of medicines and medical devices. To ensure a better public health protection as well as the safety and empowerment of patients in the Union, it is essential that patients and health systems have access to affordable high quality healthcare products and can fully benefit from them.
Amendment 336 #
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21a) The programme should contribute to the strengthening of the European Medicines Market to speed up equitable access to medicines, make care more affordable, maximize savings in national health budgets and avoid obstacles for generic and biosimilar use.
Amendment 344 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor and respond to shortages of medicines, medical devices, vaccines and diagnostic tools and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digitial transformation of healthcare products and platforms for 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.
Amendment 355 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor and to prevent shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicines.
Amendment 358 #
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22a) In its Pharmaceutical Strategy, the Commission should introduce the revision of the orphan and paediatric legislation and of the Directive 2001/83/EC establishing a Community code relating to medicinal products for human use.
Amendment 360 #
Proposal for a regulation
Recital 22 b (new)
Recital 22 b (new)
(22b) To ensure effective controls and full transparency of the procedures used to determine the prices of medicines, the Commission should propose a revision of Directive 89/105/EEC on the transparency of measures regulating the price of medicinal products.
Amendment 361 #
Proposal for a regulation
Recital 22 c (new)
Recital 22 c (new)
(22c) To reduce its dependence on third countries for certain biological and medicinal products such as blood and plasma derived medicinal products, the Union should increase its capacity to collect and stockpile blood and plasma. To avoid the risk of shortages on those products, the Union should rapidly revise the Blood, Tissues and Cells legislations, Directive 2002/98/EC and Directive 2004/23/EC.
Amendment 365 #
Proposal for a regulation
Recital 23
Recital 23
(23) As the optimal use of medicines and antimicrobials in particular yields benefits for individuals and health systems, the Programme should promote their prudent and efficient use. In line with the European One Health Action Plan against Antimicrobial Resistance14 , adopted in June 2017 following the request from Member States, and given the experience with the bacterial secondary infections related to COVID 19, it is essential that the Programme supports actions aimed at the prudent use of antimicrobials in humans, animals and crops, in the framework of an integrated policy on patient safety and prevention of medical errors. TheEU4health programme funding should be based on actions that are traceable, setting Union-wide reduction targets for antibiotics and medicine use, and support the research and development of new antibiotics __________________ 14Communication from the Commission to the Council and the European Parliament ‘A European One Health Action Plan against Antimicrobial Resistance (AMR)’, COM(2017)0339 final of 29.6.2017.
Amendment 371 #
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) According to WHO, 12.6 million people died as a result of living or working in an unhealthy environment in2012 – nearly 1 in 4 of total global deaths. Environmental pollution factors, such as air, water and soil pollution, chemical exposures, climate change, and ultraviolet radiation, contribute to more than 100 diseases and injuries.
Amendment 372 #
Proposal for a regulation
Recital 23 b (new)
Recital 23 b (new)
(23b) The Programme should promote and guarantee via its actions the environmental health of European citizens in the framework of the European Green Deal. The Union should adopt the WHO definition which describes environmental health as the inclusion of “ aspects of human health, such as the quality of life, which are determined by the physical, chemical, biological, social, psychosocial and aesthetic factors of our environment. It also concerns the policy and practices for the prevention, management and control of environmental factors likely to affect the health of present and future generations”.
Amendment 374 #
Proposal for a regulation
Recital 24
Recital 24
(24) Since environmentalthe pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem that can impact on public health, the Programme should foster measures to strengthen the assessment and appropriate management of environmental risks associated with the production, use and disposal of medicinal products, in line with the European Union Strategic Approach to Pharmaceuticals in the Environment15 . __________________ 15Communication of the Commission to the European Parliament, the Council and the European economic and Social Committee ‘European Union Strategic Approach to Pharmaceuticals in the Environment’, COM(2019)128 final of 11.03.2019.
Amendment 379 #
Proposal for a regulation
Recital 25
Recital 25
(25) The Union health legislation has an immediate impact on public health and safety, the lives of citizens, the efficiency and resilience of the health systems and the good functioning of the internal market. The regulatory framework for medical products and technologies (medicinal products, medical devices and substances of human origin), as well as for tobacco legislation, patients’ rights in cross-border healthcare and serious cross-border threats to health is essential to health protection in the Union. The Programme therefore should support the development, implementation and, enforcement and improvement of Union health legislation, adopt early and long-term evaluation criteria in order to assess its implementation and provide high quality, comparable and reliable data to underpin policymaking and monitoring.
Amendment 388 #
Proposal for a regulation
Recital 27
Recital 27
(27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases to communicable and non- communicable diseases such as, supporting the creation of 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 Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 394 #
Proposal for a regulation
Recital 27
Recital 27
(27) The ERNs, established pursuant to Directive 2011/24/EU of the European Parliament and the Council16 are virtual networks involving healthcare providers across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources. As the Networks can improve the access to diagnosis and the provision of high-quality healthcare to patients with rare conditions and can be focal points for medical training and research and dissemination of information, the Programme should contribute to the upscaling of networking through the ERNs, and other transnational networks. It should consider the extension of ERNs beyond rare diseases to complex communicable and non- communicable diseases such as cancer and in the field of health crises management. __________________ 16 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 396 #
Proposal for a regulation
Recital 27 a (new)
Recital 27 a (new)
(27a) The programme should support the EU-wide mobility of healthcare professionals, during both their education and professional careers through Erasmus + fundings, and of their particular role in improving knowledge and expertise on health threats. The programme should also facilitate the implementation of the Professional Qualifications Directive to ensure better mutual recognition of qualifications of health professionals within the Union.
Amendment 399 #
Proposal for a regulation
Recital 27 b (new)
Recital 27 b (new)
(27b) The programme should facilitate the coordination and pooling of European multicentre clinical trials and promote the research and training actions of future European universities networks.
Amendment 400 #
Proposal for a regulation
Recital 27 c (new)
Recital 27 c (new)
(27c) The programme should guarantee the sustainable funding of European research consortia on medicines, vaccines and biological tests designed for specific infectious and transmissible diseases.
Amendment 401 #
Proposal for a regulation
Recital 27 d (new)
Recital 27 d (new)
(27d) The Programme should take concrete actions against rare, complex and low-prevalence diseases. Early detection must be facilitated and projects such as “Rare 2030” encouraging with the objective to set up concrete and innovative policies for developing research and improving the lives of patients.
Amendment 402 #
Proposal for a regulation
Recital 27 e (new)
Recital 27 e (new)
(27e) The programme should facilitate the revision of the EU-OSHA’s mandate to promote healthy and safe workplaces across the Union and to support the Agency’s activities and analysis on occupational safety and health. The Commission should propose a new EU Strategic Framework on Occupational Safety and Health for the period 2021 – 2027 and continue updating the directive on the protection of workers from the risks related to carcinogens or mutagens at work. The programme should also support actions to facilitate people’s return to the workplace after long-term sick leave and to better include people who are chronically sick or have a disability in the workforce.
Amendment 403 #
Proposal for a regulation
Recital 27 f (new)
Recital 27 f (new)
(27f) The programme should effectively guarantee safe and timely access to sexual and reproductive health and rights (SRHR), goods (e.g. medicines, contraceptives) and services (e.g. sex education, safe abortions).
Amendment 405 #
Proposal for a regulation
Recital 30
Recital 30
(30) In order to optimise the added value and impact from investments funded wholly or in part through the budget of the Union, synergies should be sought in particular between the Programme for the Union's action in the field of health and other Union programmes, including those under shared-management and the Union Agencies. To maximise those synergies, key enabling mechanisms should be ensured, including cumulative funding in an action from the Programme for the Union's action in the field of health and another Union programme, as long as such cumulative funding does not exceed the total eligible costs of the action. For that purpose, this Regulation should set out appropriate rules, in particular on the possibility to declare the same cost or expenditure on a pro-rata basis to Programme for the Union's action in the field of health and another Union programme guaranteeing detailed and transparent reporting.
Amendment 406 #
Proposal for a regulation
Recital 30
Recital 30
(30) In order to optimise the added value and impact from investments funded wholly or in part through the budget of the Union, synergies should be sought in particular between the Programme for the Union's action in the field of health and other Union programmes, including those under shared-management and the EU agencies. To maximise those synergies and avoid duplications, key enabling mechanisms should be ensured, including cumulative funding in an action from the Programme for the Union's action in the field of health and another Union programme, as long as such cumulative funding does not exceed the total eligible costs of the action. For that purpose, this Regulation should set out appropriate rules, in particular on the possibility to declare the same cost or expenditure on a pro-rata basis to Programme for the Union's action in the field of health and another Union programme.
Amendment 410 #
Proposal for a regulation
Recital 33
Recital 33
(33) Given the common agreed values of solidarity towards equitable and universal coverage of quality health services as a basis for the Union’s policies in this area and that the Union has a central role to play in accelerating progress on global health challenges19 , the Programme should, in synergy and complementarity with other relevant Union programmes, support the Union’s contribution to international and global health initiatives with a view to improve health, address inequalities and increase protection against global health threats. __________________ 19Council conclusions on the EU role in Global Health, 3011th Foreign Affairs Council meeting, Brussels, 10 May 2010.
Amendment 413 #
Proposal for a regulation
Recital 36
Recital 36
(36) Cooperation with third countries should be strengthened on the exchange of knowledge and best practices in health systems preparedness and response. The programme should help building a strong and effective partnership between the Union and Africa and prioritise health systems strengthening, universal access to health services and global health research and development in the framework of the EU-Africa Strategy.
Amendment 414 #
Proposal for a regulation
Recital 39 a (new)
Recital 39 a (new)
(39a) The preamble to the Paris Agreement acknowledges the “right to health” as a key right; the article 4(1)(f) of the UNFCCC states that all Parties thereto should employ “appropriate methods, for example impacts assessments, formulated and determined nationally with a view to minimising adverse effects on the economy, on public health and on the quality of the environment, of projects or measures undertaken by them to mitigate or adapt climate change".
Amendment 415 #
Proposal for a regulation
Recital 39 b (new)
Recital 39 b (new)
(39b) According to the WHO, climate change affects the social and environmental determinants of health- clean air, safe drinking water, sufficient food and secure shelter-and that 250 000 additional deaths, from malnutrition, maladria, diarrhoea and heat stress, are expected every year between 2030 and 2050, with extreme high air temperatures contributing directly to deaths particularly amongst the elderly and vulnerable individuals. Through flood, heatwaves, drought and fires, climate change has a considerable impact on human health, including under nutrition, cardiovascular and respiratory diseases, and vector-borne infections.
Amendment 418 #
Proposal for a regulation
Recital 40
Recital 40
(40) Reflecting the importance of tackling climate change in line with the Union's commitments to implement the Paris Agreement and the United Nations 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 2530 % of the EU budget expenditures supporting climate objectives. Relevant actions will be identified during the Programme's preparation and implementation, and reassessed in the context of its mid-term evaluation.
Amendment 425 #
Proposal for a regulation
Article 2 – paragraph 1 – point 3
Article 2 – paragraph 1 – point 3
(3) ‘health crisis’ means any crisis or serious incident arising from a threat of human, animal, plant, food or, environment, biological, chemical and nuclear origin and a threat of unknown origin, having a health dimension and which requires urgent and coordinated action by authorities;
Amendment 428 #
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
(4) ‘crisis relevant products’ means products and substances necessary, in the context of a health crisis, to prevent, diagnose or treat a disease and its consequences, included but not limited to: medicinal products - including vaccines - and their intermediates, active pharmaceutical ingredients and raw materials; bloods products and organs; medical devices; hospital and medical equipment (such as ventilators, protective clothing and equipment, diagnostic materials and tools); personal protective equipment; disinfectants and their intermediary products and raw materials necessary for their production);
Amendment 432 #
Proposal for a regulation
Article 2 – paragraph 1 – point 5 a (new)
Article 2 – paragraph 1 – point 5 a (new)
(5a) “Environmental health” means aspects of human health, such as the quality of life, which are determined by the physical, chemical, biological, social, psychosocial and aesthetic factors of our environment;
Amendment 435 #
Proposal for a regulation
Article 2 – paragraph 1 – point 10 a (new)
Article 2 – paragraph 1 – point 10 a (new)
(10a) ‘Commercial determinant of health’ means strategies and approaches used by the private sector to promote products and choices that are detrimental to health;
Amendment 442 #
Proposal for a regulation
Article 3 – paragraph 1 – introductory part
Article 3 – paragraph 1 – introductory part
The Programme shall pursue the following general objectives, in keeping with the “One Health” and “Health in all policies” approaches where relevant:
Amendment 452 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) support health promotion and prevention, reduce health inequalities, improve physical and mental health and protect people in the Union from serious cross-border threats to health;
Amendment 457 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) protect people in the Union from any serious cross-border threats to health;
Amendment 465 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) improvrestore pharmaceutical independence of the Union to improve ensure the availability in the Union of medicines, vaccines and diagnostic tools, medical devices and other crisis relevant products, contribute to their affordability, and support innovation via the Pharmaceutical Strategy;
Amendment 480 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) strengthen health systems and the healthcare workforce, including by digital transformation harmonized education and training and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and data sharing, to increase the general level of public health.
Amendment 482 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) strengthen health systems and the healthcare workforce, including by digital transformation and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and data sharing, to ensure interoperablity of their actions and increase the general level of public health.
Amendment 485 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
(3a) reduce health inequalities between Member States and within Member States while taking into account the “health in all policies” approach;
Amendment 493 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3 b (new)
Article 3 – paragraph 1 – point 3 b (new)
(3b) provide integrated healthcare, accessible at local or regional level, enabling patients to be better supported in their own local and social environment;
Amendment 495 #
Proposal for a regulation
Article 4 – paragraph 1 – introductory part
Article 4 – paragraph 1 – introductory part
The general objectives referred to in Article 3 shall be pursued through the following specific objectives, in keeping with the “One Health” and “Health in all policies” approaches where relevant:
Amendment 503 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1
Article 4 – paragraph 1 – point 1
(1) strengthen the capability of the Union for prevention, preparedness and response to serious cross-border threats to health, and the management of health crises, including through organization of stress tests, coordination, provision and deployment of emergency health care capacity, data gathering and surveillance;
Amendment 506 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Article 4 – paragraph 1 – point 1 a (new)
(1a) Support the strengthening of the competences and resources of the European health agencies namely the ECDC and the EMA, the European Food Safety Authority (EFSA), European Chemicals Agency (ECHA) and EU- OSHA;
Amendment 513 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Article 4 – paragraph 1 – point 1 a (new)
(1a) The objectives of Article 4 shall be delivered in a consistent and transparent way and in a manner that is coordinated with the actions of other Union programmes and agencies.
Amendment 517 #
Proposal for a regulation
Article 4 – paragraph 1 – point 2
Article 4 – paragraph 1 – point 2
(2) ensure the availability in the Union of reserves or stockpiles of crisis relevant products, and a reserve of medical, healthcare and support staff to be mobilised in case of a crisis such as the European Medical Corps;
Amendment 523 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3
Article 4 – paragraph 1 – point 3
(3) strengthen the European Medicines Market and support actions to ensure appropriate availability, accessibility and affordability of crisis relevant products and other necessary health supplies via a strengthened EU joint procurements on treatments and vaccines;
Amendment 535 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4
Article 4 – paragraph 1 – point 4
(4) strengthen the effectiveness, accessibility, sustainability and resilience of health systems, including by supporting digital transformation, the uptake of digital tools and services, systemic reforms, implementation of new care models and universal health coverage, and addressreduce inequalities in health;
Amendment 542 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4 a (new)
Article 4 – paragraph 1 – point 4 a (new)
(4a) support the development and implementation of a European Electronic Health Record;
Amendment 550 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5
Article 4 – paragraph 1 – point 5
(5) support actions aimed at strengthening health system’s ability to foster disease prevention and health promotion, patient rights and cross-border healthcare, and promote the excellence of medical and healthcare professionals, their education, training and mobility;
Amendment 551 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5
Article 4 – paragraph 1 – point 5
(5) support actions aimed at addressing health inequality, strengthening health system’s ability to foster disease prevention and health promotion, patient rights and cross-border healthcare, and promote the excellence of medical and healthcare professionals;
Amendment 557 #
Proposal for a regulation
Article 4 – paragraph 1 – point 6
Article 4 – paragraph 1 – point 6
(6) support action for the promotion of a healthy lifestyle, surveillance, prevention, early diagnosis and treatment and care of non-communicable diseases, and notably of cancer and cardio-vascular diseases by providing a European strategic Chronic disease framework to support Member States action addressing the commercial determinants of health;
Amendment 575 #
Proposal for a regulation
Article 4 – paragraph 1 – point 6 a (new)
Article 4 – paragraph 1 – point 6 a (new)
(6a) address the unmet needs of children and adolescents with cancer, and of survivors, through dedicated programmes and plans on Paediatric Cancer, fostering research and access to novel treatment;
Amendment 583 #
Proposal for a regulation
Article 4 – paragraph 1 – point 8
Article 4 – paragraph 1 – point 8
(8) support the development, implementation and, enforcement and when necessary the revision of Union health legislation and provide high-quality, comparable and reliable data to underpin policy making and monitoring, and promote the use of health impact assessments of relevant policies to evaluate their impacts on European citizen’s health and well-being;
Amendment 587 #
Proposal for a regulation
Article 4 – paragraph 1 – point 8 a (new)
Article 4 – paragraph 1 – point 8 a (new)
(8a) ensure healthy and safe workplaces across the Union and to support EU-OSHA’s activities and analysis on occupational safety and health.
Amendment 592 #
Proposal for a regulation
Article 4 – paragraph 1 – point 9
Article 4 – paragraph 1 – point 9
(9) support integrated work among Member States, and in particular their health systems, including the implementation of high-impact prevention practices, and scaling up networking through the European Reference Networks through their extension beyond rare diseases to complex to communicable and non-communicable diseases and other transnational networks;
Amendment 602 #
Proposal for a regulation
Article 4 – paragraph 1 – point 9 a (new)
Article 4 – paragraph 1 – point 9 a (new)
(9a) support the creation of excellence networks in the field of communicable and non-communicable diseases;
Amendment 624 #
Proposal for a regulation
Article 12 – paragraph 3 a (new)
Article 12 – paragraph 3 a (new)
A reliable and efficient mechanism shall be created in order to avoid any duplication of funding and to ensure synergies between the different Union programmes and policies that are pursuing health objectives. All the data on funding operations and actions financed under different Union programmes and funds shall be centralised under this mechanism. It shall follow the principles of transparency and accountability and shall allow better monitoring and evaluation of actions pursuing health objectives.
Amendment 628 #
Proposal for a regulation
Article 14 – paragraph 1 – point b
Article 14 – paragraph 1 – point b
(b) any legal entity created under Union law or any international organisation such as public authorities, public sector bodies, health establishments, research institutes, universities and higher education establishments, patient associations etc.;
Amendment 643 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases, the Union agencies, the external independent experts on the work planrogrammes established for the Programme and its priorities and strategic orientations and its implementation.
Amendment 644 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
The Commission shall consult the health authorities of the Member States in the Steering Group on Health Promotion, Disease Prevention and Management of Non-Communicable Diseases on the work plan, the EU agencies on the annual work programmes established for the Programme and its priorities and strategic orientations and its implementation.
Amendment 649 #
Proposal for a regulation
Article 19 – paragraph 1
Article 19 – paragraph 1
1. Indicators to report on progresassess the implementation of the actions of the Programme towards the achievement of the general and specific objectives set out in Articles 3 and 4 are set out in Annex II.
Amendment 655 #
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. The interim evaluation of the Programme shall be performed and submitted to the European Parliament and to the Council once there is sufficient information available about their implementation, but not later than four years after the start of the implementation.
Amendment 656 #
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. At the end of the implementation period, but no later than four years after the end of the period specified in Article 1, a final evaluation shall be carried out by the Commission and submitted to the European Parliament and to the Council.
Amendment 657 #
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. The Commission shall publish and communicate the conclusions of the evaluations accompanied by its observations, and shall present them to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
Amendment 658 #
Proposal for a regulation
Annex I – point a – point ii
Annex I – point a – point ii
(ii) Critical health infrastructure relevant in the context of health crises, tools, structures, processes, production, storage and laboratory capacity, including tools for surveillance, modelling, forecast, prevention and management of outbreaks., in particular with investments in the least resilient national health systems;
Amendment 660 #
Proposal for a regulation
Annex I – point a – point ii
Annex I – point a – point ii
(ii) Critical health infrastructure relevant in the context of health crises, tools, mechanisms, structures, processes, production and laboratory capacity, including tools for surveillance, modelling, forecast, prevention and management of outbreaks.
Amendment 665 #
Proposal for a regulation
Annex I – point a – point ii a (new)
Annex I – point a – point ii a (new)
(iia) Support the building of hospitals in the less developed regions of the Union; the EU4Health Programme should participate in synergy and complementarity with the funds from the cohesion policy;
Amendment 667 #
Proposal for a regulation
Annex I – point a – point ii b (new)
Annex I – point a – point ii b (new)
(iib) Strengthening EU institutions, notably EMA and ECDC, to play a bigger role in managing response to cross-border heath crises and preventing medicine and medical devices shortages.
Amendment 670 #
Proposal for a regulation
Annex I – point b
Annex I – point b
(b) Transfer, adaptation and roll-out of best practices and innovative solutions with established Union level added-value between Member States, and country- specific tailor made support to countries, or groups of countries or regions, with the highest needs, through the funding of specific projects including twinning, expert advice and peer support.
Amendment 702 #
Proposal for a regulation
Annex I – point d – introductory part
Annex I – point d – introductory part
(d) Development and implementation of Union health legislation and action, for the protection and promotion of health, in particular through support to:
Amendment 712 #
Proposal for a regulation
Annex I – point d – point i
Annex I – point d – point i
(i) Implementation, enforcement, monitoring and improvement of Union health legislation and action; and technical support to the implementation of legal requirements;
Amendment 713 #
Proposal for a regulation
Annex I – point d – point i a (new)
Annex I – point d – point i a (new)
(ia) Strengthening of European Health agencies namely the European Centre for Disease Prevention and Control Centre(ECDC), the European Medicines Agency (EMA), the European Food Safety Authority (EFSA), European Chemicals Agency (ECHA) and European Agency for Safety and Health at Work(EU-OSHA).
Amendment 726 #
Proposal for a regulation
Annex I – point d – point viii
Annex I – point d – point viii
(viii) Networking by non-governmental organisations and their involvement in projects covered by the Programme and the evaluation of the implementation of the programme;
Amendment 727 #
Proposal for a regulation
Annex I – point d – point ix
Annex I – point d – point ix
(ix) Collaboration with third countries on the areas covered by the Programme especially with African countries in the framework of the EU- Africa Strategy;
Amendment 730 #
Proposal for a regulation
Annex I – point d – point x
Annex I – point d – point x
(x) National contact points providing guidance, information and assistance related the promotion and the implementation of Union health legislation and of the Programme;.
Amendment 731 #
Proposal for a regulation
Annex I – point d – point xi
Annex I – point d – point xi
(xi) Stakeholders in view of transnational and regional cooperation.
Amendment 742 #
Proposal for a regulation
Annex I – point e – point i
Annex I – point e – point i
(i) Establishment and support of a mechanism to develop, procure and manage crisis relevant productsof a European Health Response Mechanism (EHRM) to respond to all types of health crises (infectious, chemical, environmental, biological, food, nuclear) and to strengthen operational coordination at European level;
Amendment 743 #
Proposal for a regulation
Annex I – point e – point i
Annex I – point e – point i
(i) Establishment and support of a mechanism to develop, procure and, manage and secure crisis relevant products;
Amendment 744 #
Proposal for a regulation
Annex I – point e – point i a (new)
Annex I – point e – point i a (new)
(ia) Establishment of an EU contingency reserve of medicines of major therapeutic interest and medical equipment to be triggered and monitored by the European Health Reaction Mechanism(EHRM);
Amendment 777 #
Proposal for a regulation
Annex I – point f – point vii
Annex I – point f – point vii
(vii) Establishment and operation of a mechanism for cross-sectorial One-Health coordinationand Health in all policies coordination via a systematic health impact assessment, built on cross-sectorial indicators, of all EU policies and funding to evaluate their impact on improving health and well- being of our citizens.
Amendment 797 #
Proposal for a regulation
Annex I – point g – point ii
Annex I – point g – point ii
(ii) TrainingHarmonize and standardise training and educational programmes for medical and healthcare staff, and programmes for temporary exchanges of staff, with the aim to better match health workers skills with the needs of the health system;
Amendment 799 #
Proposal for a regulation
Annex I – point g – point ii
Annex I – point g – point ii
(ii) Training and mobility programmes for medical and healthcare staff, and programmes for temporary exchanges of staff;
Amendment 828 #
Proposal for a regulation
Annex I – point g – point xi a (new)
Annex I – point g – point xi a (new)
(xi a) Support Member States in the revision of their rare disease national plans to enact the necessary financial and organisational arrangements to integrate effectively ERNs system into national health systems;
Amendment 831 #
Proposal for a regulation
Annex I – point g – point xiii a (new)
Annex I – point g – point xiii a (new)
(xiiia) Support cooperation and coordination between Member States for the creation of a European Network for Hospitals Excellence, improving the cross-border treatment for rare diseases and increasing access to treatment for all Union citizens;
Amendment 882 #
Proposal for a regulation
Annex I – point h – point v a (new)
Annex I – point h – point v a (new)
(va) Support implementing policies, national programmes and guidelines to overcome inequalities in access to essential therapies and medicines, supportive and palliative care of paediatric cancers across Europe, including availability and affordability of such healthcare and service;
Amendment 903 #
Proposal for a regulation
Annex I – point h – point ix
Annex I – point h – point ix
(ix) Support to the implementation of the Union’s tobacco control policy and legislaother related legislation in the area of prevention and health promotion;
Amendment 905 #
Proposal for a regulation
Annex I – point h – point ix a (new)
Annex I – point h – point ix a (new)
(ixa) Support actions in the area of reducing and preventing alcohol abuse in the perspective of a revised EU alcohol strategy;
Amendment 928 #
Proposal for a regulation
Annex I – point i – point ii
Annex I – point i – point ii
(ii) Support actions to fight vaccine hesitancy and disinformation;
Amendment 932 #
Proposal for a regulation
Annex I – point i – point ii a (new)
Annex I – point i – point ii a (new)
(iia) Establish of a EU vaccination card;
Amendment 936 #
Proposal for a regulation
Annex I – point i – point iii
Annex I – point i – point iii
(iii) Support clinical trials to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines; support publication of all clinical reports (including CSRs) on the day of marketing authorisation;
Amendment 968 #
Proposal for a regulation
Annex I – point i – point viii
Annex I – point i – point viii
(viii) Action to strengthen the environmental risk assessment of pollution factors, such as air, water and soil pollution, chemical exposures, climate change, ultraviolet radiation and pharmaceuticals;
Amendment 976 #
Proposal for a regulation
Annex I – point i – point ix
Annex I – point i – point ix
(ix) Action to promote the prudent use and disposal of antimicrobials, setting up traceable targets for reduction in antibiotics use;
Amendment 1001 #
Proposal for a regulation
Annex I – point j – point iii
Annex I – point j – point iii
(iii) Support the deployment, standardization and interoperability of digital tools and infrastructures within and between Member States and with Union Institutions and bodies; develop appropriate governance structures and sustainable, interoperable Union health information systems, as part of the European Health Data Space and strengthen citizens’ access to and control over their health data;
Amendment 1025 #
Proposal for a regulation
Annex II – part B – point 1 a (new)
Annex II – part B – point 1 a (new)
1a. Number of Member States that implemented the European Electronic Health Record, while providing stronger guarantees for personal data protection
Amendment 1069 #
Proposal for a regulation
Annex II – part B – point 7 a (new)
Annex II – part B – point 7 a (new)
7a. Ratio of palliative care admissions and outcome result for cancer and paediatric cancer
Amendment 1079 #
Proposal for a regulation
Annex II – part B – point 8 a (new)
Annex II – part B – point 8 a (new)
8a. Obesity prevalence
Amendment 1082 #
Proposal for a regulation
Annex II – part B – point 9
Annex II – part B – point 9
9. Number of shortages of medicines in the single point of contact networkMember States