165 Amendments of Rovana PLUMB related to 2020/0102(COD)
Amendment 121 #
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4a) Article 191 TFEU provides that the Union should contribute to protecting human health through a Union policy on the environment.
Amendment 122 #
Proposal for a regulation
Recital 5
Recital 5
(5) On 11 March 2020 the World Health Organization (WHO) declared, due to an exponential increase of cases, declared COVID-19 (the disease resulting from the novel coronavirus (COVID-19SARS-CoV-2) outbreak a global pandemic. That pandemic hase COVID-19 pandemic and more specifically the moderate to severe cases of the disease that need intermediate and intensive medical care pushed several health systems to breaking point within and outside 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.
Amendment 135 #
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 andto support rights- and evidence-based approaches that have a high impact in order to improve preparedness for, prevention and a timely and effective control of the spread of severe human infections and 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 and improve 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 152 #
Proposal for a regulation
Recital 6 a (new)
Recital 6 a (new)
(6a) The pandemic has revealed the importance of public health policies, and their benefits for citizens, communities and the economy. Such policies are cost- saving and offer returns in the long term of 14:1, meaning that for each euro invested in public health policies, we have economic return of 14 euros.
Amendment 153 #
Proposal for a regulation
Recital 6 b (new)
Recital 6 b (new)
(6b) While the Union´s action in the field of health is limited, the Union should follow a coherent public health strategy in order to flexibly respond to existing epidemics taking into consideration local specificities and having the capacity to face future worrying realities and health threats, such as pandemics and cross- border threats, including antimicrobial resistance and the health impacts of the climate crisis. The Union should support Member States in reducing health inequalities and in achieving universal health coverage, addressing the challenges of an ageing population, of chronic diseases, of disease prevention, in promoting a healthy lifestyle and preparing their health systems for emerging technologies.
Amendment 155 #
Proposal for a regulation
Recital 6 c (new)
Recital 6 c (new)
Amendment 156 #
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 health, called EU4Health Programme ('the Programme') for the period 2021 -2027. In line with the goals of the Union action and its competences in the area of public health the Programme should place emphasis on actions in relation to which there are advantages and efficiency gains from collaboration and cooperation at Union level and actions with an impact on the internal market. The EU regulates products relevant to health and health outcomes including, amongst others, pharmaceuticals, medical devices, tobacco, alcohol, food and chemicals, therefore the Programme should take into consideration regulation in such areas to improve the health outcomes in the EU. A holistic approach is needed to improve health outcomes, and EU policy-makers should ensure that the principle of 'health in all policies' is applied in all policy- making.
Amendment 159 #
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. 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] and ensure that resilient healthcare and health systems are in place in preparation for future pandemics, improve the health status in 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.
Amendment 166 #
Proposal for a regulation
Recital 10
Recital 10
(10) COVID-19 has demonstrated the inter-dependencies between human health and the health of our planet and our vulnerabilities. The emergence of zoonotic diseases which are transmitted from animals to humans is exacerbated by anthropogenic climate change, the destruction of biodiversity and environmental degradation. Due to the serious nature of cross- border health threats, the Programme should support coordinated public health measures at Union level to address different aspects of such threats. With a view to strengthen the capability in the Union to prepare for, respond to and manage health crisis the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include strategic stockpiling of essential medical supplies or capacity building in crisis response, preventive measures related to vaccination and immunisation, strengthened surveillance programmes. In this context the Programme should foster Union-wide and cross-sectoral crisis prevention, preparedness, surveillance, management 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 186 #
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. such as the elderly, children, Roma, migrants, and people living in a socioeconomically precarious situation, amongst others, including those suffering from non-communicable diseases, such as cardiovascular diseases, 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 increasing their efficiency and availability in responding to demands.
Amendment 195 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) The right to physical and mental health is a fundamental human right. Every person, without discrimination, has the right to access modern and comprehensive healthcare. The EU4Health programme should guarantee that universal health coverage is provided, in line with the international commitments made through SDGs and with WHO policies, and ensure that everyone can use the health services they need without experiencing financial hardship. To continue being a global leader in health and to provide a high standard healthcare across the Union, the Commission should propose a Directive on minimum standards for quality healthcare with a set of criteria that should be reported by Member States, such as hospital beds per capita, critical care capacities, numbers of doctors and nurses per capita, rate of health expenditure and access and affordability of healthcare for all, including for vulnerable people. This would improve patient safety and result in better conditions in healthcare for patients and professionals.
Amendment 203 #
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 of crisismedical and care relevant products to mitigate the risk of shortages, especially in times of health crises, ensuring complementarity with other Union instruments.
Amendment 205 #
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 and ensure their capability to respond to health emergencies, that includes contingency planning, preparedness exercises and the upskilling of health care and public health staff and the establishment of mechanisms for the efficient monitoring and needs-driven distribution or allocation of goods and services needed in time of crisis. The benchmarking, cooperation and exchange of best practices should be equally promoted in periods where there are no crises.
Amendment 219 #
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, sustainability and resilience. In the context of such transformation and reforms, the Programme should promote, in synergy with the Digital Europe Programme, actions which advance digital transformation of health services and increase their interoperability, contribute to the increased capacity of health systems to foster (primordial, primary, secondary, tertiary and quaternary) disease prevention and health promotion, to provide new outcome -based care models and to deliver integrated services, from the community and primary health care to the highly specialised services, based on people's needs enhancing citizens’ levels of health literacy and digital health literacy and ensure an efficient public health workforce equipped with the right skills, including digital skills, regularly updated in the light of scientific and technological progress, as provided for by Directive 2005/36 on the recognition of professional qualifications . This synergy between European Health Programme and Digital Europe Programme should contribute to the implementation and expansion of e-health, as telemedicine, reducing unnecessary travel and unmet healthcare needs. The development of a European health data space and of a European Electronic Health Record would provide health care systems, researchers and public authorities with means to improve the accessibility, affordability, availability and quality of healthcare, increasing the amount of data available to patients and health workers 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, 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. __________________ 12Council Conclusions on Common values and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1).
Amendment 228 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) The value of health data is essential for having more reliable information to improve healthcare services, health policy-making and to evaluate the implementation of actions and policies in our society. The European Health Data Space will represent a strong pillar of health in the Union and should be constructed involving all sectors and stakeholders, taking into account the needs of health professionals and patient. The Programme should capacitate and enlarge the competence of the ECDC to improve the capacity of surveillance of NCDs. The European Health Data should collect data on healthcare use, health behaviour and health problems, including information on rare diseases, vaccination, allergies and others.
Amendment 238 #
Proposal for a regulation
Recital 16
Recital 16
(16) Health is an investment and the Programme should have this concept at its core. Keeping people healthy and active longer and empowering them to take an active role in managing their health through health literacy in order to take well informed decisions, will have positive effects on health, health inequalities, health iniquities, quality of life, productivity, competitiveness and inclusiveness, while reducing pressures on national health systems and budgets. The Commission has committed to help Member States to reach the sustainable development targets set in the 'UN 2030 Agenda for Sustainable Development’ in particular Sustainable Development Goal 3 "Ensure healthy lives and promote well- being for all at all ages"13. The Programme therefore should contribute to the actions taken towards reaching the SDGse goals, consequently will improve the social determinants of health and enhance the health of the Union. __________________ 13 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Next steps for a sustainable European future. European action for sustainability COM (2016) 739 final of 22.11.2016.
Amendment 242 #
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) The Programme should provide for equal and fair access to healthcare. “Health inequalities” cover situations ranging from unequal access to treatment, fragmented access across regions, differences in health status origin, and to the distribution of health determinants between different population groups. Health inequalities and inequities are avoidable by reasonable means, and thus preventable, and the Programme should improve the knowledge on health inequalities and inequities to tackle them.
Amendment 247 #
Proposal for a regulation
Recital 17
Recital 17
(17) Non-communicable diseases are a result of commercial determinants of health a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes and mental health illnes,s represent major causes of disability, ill-health, health- related retirement, and premature death in the Union, with non- communicable diseases (NCDs) were responsible for 87% of Disability-Adjusted Life Years (DALYs) in the EU in 2017, 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, particularly but not exclusively Target 3.4, to reduce premature mortality from non- communicable diseases by one third by 2030, it is key to provide an integrated response focusing on 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.
Amendment 264 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) Mental and psychological well- being is crucial for good mental health. The Programme should be aimed at improving the mental health of individuals and society, including the promotion of mental well-being, the prevention of mental disorders, the protection of human rights and the care of people affected by mental disorders and neurological diseases.
Amendment 267 #
Proposal for a regulation
Recital 17 b (new)
Recital 17 b (new)
(17b) Early detection and screening plays a crucial role in prevention strategies and in timely treatment and health outcomes. Prevention is key in achieving sustainable health systems by ensuring that citizens live disease-free longer and by reducing the pressure of preventable diseases, especially of non- communicable diseases, on health systems. In order to enhance the health status, well-being, and quality of life of Union citizens, primary care healthcare professionals, including community pharmacists, local authorities and citizens should be involved in raising public health awareness, participating in disease prevention and control. The Programme should support Union actions and support Member States in developing and implementing prevention, early diagnosis and screening strategies. This includes disease prevention services as part of primary healthcare services.
Amendment 271 #
Proposal for a regulation
Recital 18
Recital 18
(18) The Programme therefore should contribute tohave a holistic approach to individual health and the link with all the health determinants: socio-economic, environmental, health system, commercial and individual determinants of health. To achieve the best health status possible, the Programme should tackle all the determinants. Health promotion, health protection and disease prevention throughout the lifetime of an individual and to healshould be at the core of the promotiongramme by addressing health and mental risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugharmful drugs and other addictive behaviours. The Programme should also contribute to the reduction of drugs-related health damage, unhealthy dietary habits and, lack of physical inactivity 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 therefore 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.
Amendment 288 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) Given that health needs differ during a person's lifetime, the Programme should also support Member States to create and implement health programmes that are aligned with the needs of population, and should work to achieve a minimum standard in health programmes that tackle specific populations, such as children's health, maternal health and ageing-related health, as programmes that are horizontal to the lifetime as mental health and reproductive and sexual health.
Amendment 293 #
Proposal for a regulation
Recital 18 b (new)
Recital 18 b (new)
(18b) The burden of chronic diseases is still significant in the Union. Chronic diseases develop slowly, are long-lasting and often incurable. Chronic diseases are, in many cases, associated with more than one comorbidity, which makes them even more difficult to treat and manage. They have caused great human suffering and placed an enormous burden on health systems, as well. However, many chronic diseases, such as cardiovascular diseases, cancer and type 2 diabetes, could be prevented through access to prevention services, affordability of healthy nutrition and healthy lifestyle, while other illnesses, for instance neurological diseases, can be managed to slow their onset if detected early, or helping patients feel their best and remain active for longer. The Union and Member States can therefore greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, including prevention, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines in the area of both communicable and non- communicable diseases, such as cardiovascular diseases, neurodegenerative diseases, cancer, respiratory diseases and diabetes.
Amendment 295 #
Proposal for a regulation
Recital 18 c (new)
Recital 18 c (new)
(18c) The International Agency for Research on Cancer (IARC) considered classified diesel engine exhaust as carcinogenic to humans. The Programme should make sure that the health impacts and costs of air pollution are integrated into the Union action against cancer, while ensuring full coherence with the European zero emission strategy.
Amendment 300 #
Proposal for a regulation
Recital 19
Recital 19
(19) Cancer is the second leading cause of mortality in the Member States after cardiovascular diseases. It is also one of several non-communicable diseases that share common risk factors. Addressing the prevention of cancer along with other NCDs in a coordinated fashion and the prevention and control of which would benefit the majority of citizens. In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover the entire cycle of the disease starting from prevention and early diagnosis to treatment and quality of life of patients and survivors 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.
Amendment 307 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) Under Article 153 TFEU, the Union is to support and complement the activities of Member States concerning improvement of the working environment, and protection of workers' health, safety and working conditions. Considering the large amount of time that the workers spend in their workplaces and the possible risk they could have, such as exposure to health hazard substances and carcinogens and to repeated movements, leading to a high burden of incapacity and number of work days lost, which in turn has consequences for the individual, family and society. The Programme should also reflect the importance of occupational health and its impact on health workers and societies. The Commission should work with Member States to create new legislation to improve workers health conditions, improve their working conditions, the balance between work and life, promote wellbeing and better mental health, prevent early-retirement due to ill health and poor health management.
Amendment 320 #
Proposal for a regulation
Recital 19 b (new)
Recital 19 b (new)
(19b) While the Union currently has a strong focus on cancer as expressed in ‘Europe’s Beating Cancer Plan’ and Horizon Europe’s Mission on Cancer, the Programme should ensure that patients living with other major chronic diseases such as cardiovascular disease, chronic respiratory disease, diabetes and mental health conditions benefit from it in a proportionate manner.
Amendment 322 #
Proposal for a regulation
Recital 19 c (new)
Recital 19 c (new)
(19c) A crucial part of treatment of diseases is rehabilitation, including counselling, medical treatment, exercise and psychological support. These programmes help prevent recurrence, optimise quality of life, reintegrate patients into the job market and reduce the burden on health services by reducing hospital readmissions. Although there are considerable benefits for patients, as well as the wider society, the access to and uptake of quality rehabilitation is patchy in most of the Member States and is considered an underutilised resource. The Programme should support increased uptake of rehabilitation and secondary prevention reducing the burden of diseases.
Amendment 329 #
Proposal for a regulation
Recital 20 a (new)
Recital 20 a (new)
(20a) The programme should support vulnerable population groups that have more difficulty in accessing healthcare, due to their socio-economic or geographic characteristics. Synergies between the Programme and ESF+ and ERDF are crucial, and the Commission should take into account the particularity of remotes areas and more concretely, the outermost regions based on Article 349 TFEU.
Amendment 334 #
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 sustainable, efficient, equitable and high quality healthcare products and can fully benefit from them.
Amendment 341 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such and medical devices, promote research and the development of new medicinal products as antimicrobials and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicin, with particular attention to antimicrobials and vaccines to tackle AMR and vaccine-preventable 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.
Amendment 363 #
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. 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. __________________ 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 369 #
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) HAI are infections that patients get while receiving healthcare for another condition or infections suffered by inhabitants of long-term residences. The ECDC has estimated that, on average, healthcare associated infections occur in one hospitalised patient in 20, that is to say 4,1 million patients a year in the Union, and that 37 000 deaths are caused every year as a result of such infections. Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. HAI can happen in any healthcare facility, including hospitals, ambulatory surgical centres, end-stage renal disease facilities, and long-term care facilities It is therefore important that the Commission, under the Programme, develops guidelines for preventing HAI, and that the Programme supports investment in modernizing health systems to overcome and reduce HAI and supports interventions to improve patient safety, including the implementation of the Council's Recommendation of 9 June 2009 on patient safety, including the prevention and control of HAI 1a.
Amendment 373 #
Proposal for a regulation
Recital 24
Recital 24
(24) Since environmental pollution caused by human and veterinary pharmaceutical substances is an emerging environmental problem that can impact on public health, the Programme should foster measures to strengthen the assessment and appropriate management of environmental risks associated with the production, use and disposal of medicinal products, in line with the European Union Strategic Approach to Pharmaceuticals in the Environment15 . The Programme will reinforce the need to have health impact assessments in the EU policies and should promote health promotion and protection 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. __________________ 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 375 #
Proposal for a regulation
Recital 25
Recital 25
(25) The Union health legislation has an immediate impact on public health, the lives of citizens, the efficiency and resilience of the health systems and the good functioning of the internal market. The regulatory framework for the recognition of professional qualifications, medical products and technologies (medicinal products, medical devices and substances of human origin), as well as for tobacco legislation, patients’ rights in cross-border healthcare and serious cross- border threats to health is essential to health protection in the Union. The Programme therefore should support the development, implementation and enforcement of Union health legislation and provide high quality, unbiased, comparable and reliable data to underpin policymaking and monitoring. Union health legislation needs to be based on current scientific evidence-based data, that should be collected locally across Europe, through a well-defined homogeneous methodology. The legislation and its implementation and consequences should be evaluated and reported, resulting in a cycle of quality improvement of health in the Union.
Amendment 386 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(26a) Solidarity and unity are principles of the Union and the programme should ensure that the Union has a coherent approach to combating cross-border health-threats. Under Article 168 TFEU, the Programme should support the creation of a European Health Response Mechanism, ready to respond to public health threats, coordinated by the ECDC and led by the Commissioner for Health and the Commissioner for Crisis Management, fully articulated with the other EU health agencies. This Mechanism with its own medical resources under a strengthened Union Civil Protection Mechanism will be prepared with a pandemic emergency plan, in order to have a coordinated response and the capacity to rapidly scale up the response to future health crises, based on standardised information.
Amendment 389 #
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 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 prevalencer. __________________ 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 412 #
Proposal for a regulation
Recital 34
Recital 34
(34) In order to maximise the effectiveness and efficiency of actions at Union and international level, cooperation should be developed with the Member States and with relevant international organisations such as the United Nations and its specialised agencies, in particular the WHO, the World Bank, as well as with the Council of Europe and the Organisation for Economic Co-operation and Development (OECD) to implement the Programme. Pursuant to Article 94 of Council Decision 2013/755/EU20 , persons and entities established in Overseas Countries and Territories (OCTs) are eligible for funding subject to the rules and objectives of the Programme and possible arrangements applicable to the Member State to which the relevant OCTs are linked. __________________ 20Council Decision 2013/755/EU of 25 November 2013 on the association of the overseas countries and territories with the European Union ( ‘Overseas Association Decision’ ) (OJ L 344, 19.12.2013, p. 1).
Amendment 420 #
Proposal for a regulation
Recital 43
Recital 43
(43) Given the nature and potential scale of cross-border threats to human health, the objective of protecting people in the Union from such threats and to increase crisis prevention and preparedness cannot be sufficiently achieved by the Member States acting alone. In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on the European Union, action at Union level can also be taken to support Member States’ efforts in the pursuit of a high level of protection of public health, to improve the availability, sustainability, acceptability, accessibility and affordability in the Union of medicines, medical devices and other crisishealth relevant products, to support innovation and to support integrated and coordinated work and implementation of best practices among Member States, and to address inequalities and inequities in access to health throughout the EU in a manner that creates efficiency gains and value-added impacts that could not be generated by action taken at national level while respecting the Member States’ competence and responsibility in the areas covered by the Programme. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
Amendment 424 #
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, chemical, biological, environmental, nuclear or unknown origin, having a health dimension and which requires urgent action by authorities;
Amendment 426 #
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
(4) ‘crisis relevant products’ means products and; substances and tools necessary, in the context of a health crisis, to prevent, diagnose or treat a disease and its consequences, includedto the monitoring and the epidemiological surveillance of the diseases and infections, including but not limited to: medicinal products - including vaccines - and their intermediates, active pharmaceutical ingredients and raw materials; medical devices; hospital and medical equipment (such as ventilators, protective clothing and equipment, diagnostic materials and tools); personal protective equipment; disinfectants and their intermediary products and raw materials necessary for their production); training; infrastructure and technology to increase the availability of data;
Amendment 429 #
Proposal for a regulation
Article 2 – paragraph 1 – point 5
Article 2 – paragraph 1 – point 5
(5) ‘One Health approach’ means an approach which recognises thate interconnection between the human and, animal health are interconnectedand environmental spheres, that diseases may be transmitted from humans to animals and vice versaone pillar to another and must therefore be tackled in both, and that the environment links humans and animalsa holistic approach;
Amendment 433 #
Proposal for a regulation
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
(9) ‘serious cross-border threat to health’ means a life- threatening or otherwise serious hazard to health of biological, chemical, radiological, nuclear, environmental or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection;
Amendment 453 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) protect people in the Union from serious cross-border threats to health; implement better preparedness and coordination within and between Member States as regards health emergencies;
Amendment 460 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) support existing and future Union health legislation, improve the availability in the Union of medicines, vaccines, medical devices and other crisismedical relevant products, contribute to their affordability, and support innovation and e-health solutions, contribute to their accessibility, sustainability and affordability, and support research, innovation and development in health and healthcare;
Amendment 476 #
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 and green transformation, and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and comparable data sharing, to increase the general level of public health and health literacy of the population.
Amendment 486 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
(3a) support systematic health impact assessment of other EU policies ensuring a comprehensive, Health in All Policies approach;
Amendment 492 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3 b (new)
Article 3 – paragraph 1 – point 3 b (new)
(3b) support health promotion, health protection and disease prevention, reduce health inequalities and inequities, improve physical and mental health, addressing in particular the key lifestyle related risk factors with a focus on the Union added value and scale up to healthier and more resilient societies;
Amendment 502 #
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 coordination, provision and deployment of emergency health care capacity, data gathering and, surveillance and health risk assessment;
Amendment 515 #
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 crisismedical relevant products, and a reserve of medical, healthcare and support staff to be mobilised in case of a crisis, improving the training of health professionals and updating their knowledge;
Amendment 520 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3
Article 4 – paragraph 1 – point 3
(3) support actions to ensure appropriate availability, accessibility, sustainability and affordability of crisis relevant productmedicines, vaccines, medical devices and other necessary health supplies, stimulate the development of the health production industry within the Union;
Amendment 528 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3 a (new)
Article 4 – paragraph 1 – point 3 a (new)
(3a) support the research and development of new medicines, medical devices and health products, enhance clinical trials and research based on real world data;
Amendment 530 #
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 green and digital transformation, the uptake of digital tools and services, systemic reforms, implementation of new care models leading to person-centred systems and universal health coverage, and address inequalities in healthand inequities in health and promote a set of minimal health services standards and ensure that the right to affordable preventive and curative health and care as set out in the European Pillar of Social Rights is respected;
Amendment 536 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4 a (new)
Article 4 – paragraph 1 – point 4 a (new)
(4a) support the digitalization of health, increasing the skills of citizens and health workers and services, the interoperability of systems and availability of data, ensuring data comparability, to improve the knowledge and evidence on health, support the creation and implementation of a European Health Data Space while respecting citizens´ data protection rights and the Union data protection framework;
Amendment 545 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5
Article 4 – paragraph 1 – point 5
(5) support actions aimed at addressing health inequalities and strengthening health system’s ability to foster protection, disease prevention and health promotion, early diagnosis and screening, and implement health promotion inclusive of mental health, patient rights and safety and cross-border healthcare, and promote the excellence of medical and healthcare professionals as well as their education, enhance their fixation and mitigate the consequences of the 'brain drain' phenomenon, scale up the occupational health of all workers and address the protection and safety of healthcare professionals;
Amendment 556 #
Proposal for a regulation
Article 4 – paragraph 1 – point 6
Article 4 – paragraph 1 – point 6
(6) support action for the surveillance, prevention, diagnosis and treatment and care of non-communicable diseases, and notably of cancerincluding cardiovascular diseases, cancer, chronic respiratory disease, diabetes and mental health conditions, with the aim of reducing the prevalence and improving the quality of life of patients, by providing a European strategic chronic disease framework to support Member States' action addressing the commercial determinants of health;
Amendment 574 #
Proposal for a regulation
Article 4 – paragraph 1 – point 6 a (new)
Article 4 – paragraph 1 – point 6 a (new)
(6a) strengthen the programmes to fight against communicable diseases and health threats, as AMR, HIV/AIDS, tuberculosis, hepatitis, influenza, sexually transmitted infections among others, promoting healthy lifestyles, premature detection, access to treatment and long- life care;
Amendment 578 #
Proposal for a regulation
Article 4 – paragraph 1 – point 7
Article 4 – paragraph 1 – point 7
(7) foster and support the informed, prudent and efficient use of medicines, and in particular of antimicrobials, and more environmentally friendly production and disposal of medicines and medical devicesinvest in the protection of the environment and sustainability in the whole value chain of all medicines, vaccines, medical devices and other medical products, from the production to the disposal, guaranteeing that an environmental risk assessment for such products is carried out;
Amendment 590 #
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, the identification of health technologies meant to benefit from a European assessment, and scaling up networking through the European Reference Networks and other transnational networks aiming to increase the coverage of patients and the response to more diseases and health problems;
Amendment 652 #
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. The interim evaluation of the Programme shall be performed once there is sufficient information available about their implementation, but not later than four years after the start of the implementation and before any decision is taken on future work programmes. The results of the interim evaluation shall be made public.
Amendment 659 #
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 and laboratory capacity, including tools for surveillance, modelling, forecast, prevention and management of outbreaks and relevant medical products.
Amendment 680 #
Proposal for a regulation
Annex I – point c – point iii
Annex I – point c – point iii
(iii) Expert groups and panels providing advice, data and information to support health policy development and implementation, including the follow-up evaluation of the implementation of health policies;
Amendment 699 #
Proposal for a regulation
Annex I – point c – point iv a (new)
Annex I – point c – point iv a (new)
(iva) Development and operation of databases and digital tools and their interoperability of health data, including where appropriate with other sensing technologies, such as space-based technology and to support access to and analysis of data from real world healthcare settings; support the implementation of artificial intelligence and other tools in order to improve the quality of health data;
Amendment 711 #
Proposal for a regulation
Annex I – point d – point i
Annex I – point d – point i
(i) Implementation, enforcement, monitoring of Union health legislation and action for the protection and promotion of health; and technical support to the implementation of legal requirements;
Amendment 736 #
Proposal for a regulation
Annex I – point d – point xi a (new)
Annex I – point d – point xi a (new)
(xia) Systematic health impact assessment of other Union policy actions;
Amendment 745 #
Proposal for a regulation
Annex I – point e – point ii
Annex I – point e – point ii
(ii) Establishment and management of EU reserves and stockpiles of crisisof medically relevant products in complementarity with other Union instruments;
Amendment 753 #
Proposal for a regulation
Annex I – point e – point v
Annex I – point e – point v
(v) Establishment and operation of a Union health response mechanism coordinated by the ECDC and with the assistance of other health-related agencies (EMA, EFSA, ECHA, EEA) of a Union reserve of medical and healthcare staff and experts and of a mechanism to deploy such staff and experts as necessary to prevent or respond to a health crisis throughout the Union; establishment and operation of a Union Health Emergency team to provide expert advice and technical assistance on request by the Commission in the case of a potential health crisis or health threat;
Amendment 755 #
Proposal for a regulation
Annex I – point e – point v a (new)
Annex I – point e – point v a (new)
(va) Strengthening mechanisms that ensure the availability of blood components, organs, tissues and cells at European level;
Amendment 762 #
Proposal for a regulation
Annex I – point f – point iv
Annex I – point f – point iv
(iv) Preventive actions to protect all citizens, taking into consideration and paying special attention to vulnerable and risk groups from health threats and actions to adjust the response to and management of crisis to the needs of those vulnerable groups; the health crisis in view of the ensuing needs, and ensure that those vulnerable groups receive uninterrupted basic care and avoid their health status being degraded;
Amendment 767 #
Proposal for a regulation
Annex I – point f – point v
Annex I – point f – point v
(v) Actions to address and manage the collateral health consequences of a health crisis, in particular those on mental health, on patients suffering from chronic diseases and other vulnerable groups, such as people living with addiction, with HIV/AIDS, tuberculosis or in socially vulnerable situations;
Amendment 771 #
Proposal for a regulation
Annex I – point f – point v a (new)
Annex I – point f – point v a (new)
(v a) Actions to support e-health, the transition to telemedicine, the use of digital health tools, enabling patients to use e-health solutions and implement self- care plans, empowering citizens and patients to self-manage as regards their health;
Amendment 776 #
Proposal for a regulation
Annex I – point f – point vi
Annex I – point f – point vi
(vi) Actions to strengthen surge capacity, research, development, laboratory capacity, production and deployment of crisis-relevant niche products;
Amendment 778 #
Proposal for a regulation
Annex I – point f – point vii a (new)
Annex I – point f – point vii a (new)
(viia) Establishment and operation of a mechanism responsible for procurement and development of countermeasures against biological threats, including bioterrorism, and chemical, nuclear and radiological threats;
Amendment 784 #
Proposal for a regulation
Annex I – point f – point viii a (new)
Annex I – point f – point viii a (new)
(viii a) Support action regarding epidemiological surveillance, focusing on national health entities, thus contributing to assessment of factors that affect or determine the health of citizens;
Amendment 789 #
Proposal for a regulation
Annex I – point f – point viii b (new)
Annex I – point f – point viii b (new)
(viiib) Support actions aimed at preventing the risks for individual and collective health that are associated with human organ trafficking and human trafficking for the purpose of organ procurement;
Amendment 792 #
Proposal for a regulation
Annex I – point g – introductory part
Annex I – point g – introductory part
(g) Strengthen national health systems, promote and protect health and prevent diseases:
Amendment 793 #
Proposal for a regulation
Annex I – point g – point i
Annex I – point g – point i
(i) Support knowledge transfer actions and Union level cooperation to assist national reform processes towards improved effectiveness, accessibility, sustainability and resilience, in particular to address the challenges identified by the European Semester and to strengthen primary care, reinforce the integration of care and aim at universal health coverage and equal access to healthcare, regarding citizens' biopsychosocial needs, and harmonise minimum standards for quality healthcare;
Amendment 801 #
Proposal for a regulation
Annex I – point g – point iii
Annex I – point g – point iii
(iii) Support toactions to address the decision of qualified health workers to leave their Member State of origin to work elsewhere, improve the geographical distribution of healthcare workforce, and avoidance of ‘medical deserts’void ‘medical deserts’ and the phenomenon of ‘brain drain’, and promote and implement retention policies in the healthcare sector as well in the health investigation and development sector;
Amendment 805 #
Proposal for a regulation
Annex I – point g – point iv
Annex I – point g – point iv
(iv) Support the establishment and coordination and deployment of Union Reference Laboratories and Centres, and of Centres of excellence of excellence, improve the access of and the coverage to all citizens that need it , and support the establishment of Union disease-specific platforms for the exchange, comparison and benchmarking of best practices between Member States;
Amendment 806 #
Proposal for a regulation
Annex I – point g – point v
Annex I – point g – point v
(v) Audit of Member States preparedness and response arrangements (such as crisis management, antimicrobial resistance, vaccination), and implementation of health programmes that address health promotion and disease prevention and tackle communicable and non-communicable diseases;
Amendment 817 #
Proposal for a regulation
Annex I – point g – point ix
Annex I – point g – point ix
(ix) Support the establishment and implementation of programmes assisting Member States and their action to improve health promotion and disease prevention (for communicable and non-communicable diseases) and mitigate the main risk factors of chronic diseases;
Amendment 820 #
Proposal for a regulation
Annex I – point g – point ix a (new)
Annex I – point g – point ix a (new)
(ixa) Support the development and the implementation of European disease management guidelines in the area of both communicable and non- communicable diseases, such as cancer, paediatric cancer, cardiovascular diseases, neurodegenerative diseases, respiratory diseases and diabetes, among others;
Amendment 822 #
Proposal for a regulation
Annex I – point g – point x
Annex I – point g – point x
(x) Support Member States’ actions to put in place healthy and safe urban, work and school environments, to enable healthy life choices and promote the regular practice of physical activity and healthy diets taking into account the needs of vulnerable groups;
Amendment 825 #
Proposal for a regulation
Annex I – point g – point xi a (new)
Annex I – point g – point xi a (new)
(xia) Advance the integration of ERNs into national health systems, by supporting the organisation of national multi-stakeholder workshops on integration to stimulate local discussions, as well as the development and implementation of the set of policies, rules and procedures required to anchor the ERN system to the national level;
Amendment 833 #
Proposal for a regulation
Annex I – point g – point xiii a (new)
Annex I – point g – point xiii a (new)
(xiiia) Support actions to combat all types of discrimination concerning patients and to ensure that there is equal access for all to health;
Amendment 836 #
Proposal for a regulation
Annex I – point g – point xiii b (new)
Annex I – point g – point xiii b (new)
(xiiib) Support actions to adopt a common set of health determinants and methodologies, and support Member States to collect, analyse and report these data and improve the knowledge, and support Union actions to mitigate health inequalities and iniquities;
Amendment 838 #
Proposal for a regulation
Annex I – point g – point xiii c (new)
Annex I – point g – point xiii c (new)
(xiiic) Improve the current monitoring system of the Union to measure the extent of healthcare exclusion, collect data and report publicly on access barriers experienced by patients, and develop more accurate indicators where needed to capture these;
Amendment 839 #
Proposal for a regulation
Annex I – point g – point xiii d (new)
Annex I – point g – point xiii d (new)
(xiiid) Support Member States’ actions to boost health education and health literacy, creating well-informed societies, enhancing healthier lifestyles;
Amendment 840 #
Proposal for a regulation
Annex I – point g – point xiii e (new)
Annex I – point g – point xiii e (new)
(xiiie) Support the creation and promotion of a Union platform for reliable and updated health information, available in all official languages of the Union, with food, medicines, health, sports and data on other issues;
Amendment 841 #
Proposal for a regulation
Annex I – point g – point xiii f (new)
Annex I – point g – point xiii f (new)
(xiiif) Support the development and implementation of guidelines on health promotion and disease prevention in different stages of a person's lifetime and needs; creating quality standards to focus on, inter alia, child health, maternal health, aging health, mental health and reproductive and sexual health;
Amendment 842 #
Proposal for a regulation
Annex I – point g – point xiii g (new)
Annex I – point g – point xiii g (new)
(xiiig) Support action to reduce health inequalities and inequities and reduce the unmet needs of vulnerable people, people living with chronic diseases, disabilities or incapacities;
Amendment 843 #
Proposal for a regulation
Annex I – point g – point xiii h (new)
Annex I – point g – point xiii h (new)
(xiiih) Support collaboration between different sectors to improve health determinants and enhance the benefits in health outcomes;
Amendment 844 #
Proposal for a regulation
Annex I – point g – point xiii i (new)
Annex I – point g – point xiii i (new)
(xiiii) Support the establishment of quality assurance schemes for disease- specific centres;
Amendment 845 #
Proposal for a regulation
Annex I – point g – point xiii j (new)
Annex I – point g – point xiii j (new)
(xiiij) Actions supporting the quality of life of chronic disease patients, care givers and informal carers;
Amendment 846 #
Proposal for a regulation
Annex I – point g – point xiii k (new)
Annex I – point g – point xiii k (new)
(xiiik) Actions supporting continuity of care (integrated care approaches for prevention, diagnosis, treatment and follow-up care);
Amendment 885 #
Proposal for a regulation
Annex I – point h – point v a (new)
Annex I – point h – point v a (new)
(va) Support equal and timely access to truly innovative medicines and therapies;
Amendment 888 #
Proposal for a regulation
Annex I – point h – point v b (new)
Annex I – point h – point v b (new)
(vb) Support implementing policies, national programmes and guidelines regarding reducing inequalities in access to essential therapies and medicines, supportive and palliative care of paediatric cancers across Europe, including availability and affordability of such health care and services;
Amendment 929 #
Proposal for a regulation
Annex I – point i – point ii a (new)
Annex I – point i – point ii a (new)
(iia) Support tools and platforms to collect real-world data to produce real- world evidence, promote research and evidence on the safety, effectiveness and impact of vaccines, while guaranteeing robust evidence generation in the pre- approval phase;
Amendment 933 #
Proposal for a regulation
Annex I – point i – point iii
Annex I – point i – point iii
(iii) Support clinical trials, including those involving increased coordination at Union level and with EMA, to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines; support publication of all clinical reports (including CSRs) on the day marketing authorisation is granted for such medicines and vaccines;
Amendment 941 #
Proposal for a regulation
Annex I – point i – point iv
Annex I – point i – point iv
(iv) Support action to ensure greater availability and affordability in the Union of medicines, vaccines, and medical devices and contribute to their affordability for patients and health systems, using the Union mechanism as joint procurement at the same time enhance the transparency of the process;
Amendment 949 #
Proposal for a regulation
Annex I – point i – point v
Annex I – point i – point v
(v) Support action to encourage the development of innovative products andion of less commercially interesting products such as antimicrobial; encourage the development of medicines for rare diseases and making access to them affordable, and investment in the research and development of new antimicrobials and other medicines to fight against communicable diseases;
Amendment 951 #
Proposal for a regulation
Annex I – point i – point v a (new)
Annex I – point i – point v a (new)
(va) Support actions to implement models of R&D and IP ownership and management which prioritise the public interest and ensure that there are societal benefits, for example by including binding safeguards to ensure availability, accessibility and affordability of medical products developed with public funds;
Amendment 970 #
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 pharmaceuticals and medical devices;
Amendment 974 #
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, surveillance of antimicrobial use, antimicrobial resistance and support action to fight against AMR;
Amendment 979 #
Proposal for a regulation
Annex I – point i – point x
Annex I – point i – point x
(x) Support action to foster international regulatory convergence on medicines and, vaccines, medical devices. and products and e-health solutions;
Amendment 982 #
Proposal for a regulation
Annex I – point i – point x a (new)
Annex I – point i – point x a (new)
(xa) Support the creation of national tools to implement the health technology assessments (HTA);
Amendment 983 #
Proposal for a regulation
Annex I – point i – point x b (new)
Annex I – point i – point x b (new)
(xb) action to promote data transparency in the entire value chain of medicines;
Amendment 984 #
Proposal for a regulation
Annex I – point i – point x c (new)
Annex I – point i – point x c (new)
(xc) action to create scientific advisory systems at national and Union level that support SMEs, Start-ups and others in the health sector;
Amendment 985 #
Proposal for a regulation
Annex I – point i – point x d (new)
Annex I – point i – point x d (new)
(xd) Support actions aimed at strengthening the fight against counterfeiting and piracy of medicines and medical devices;
Amendment 986 #
Proposal for a regulation
Annex I – point i – point x e (new)
Annex I – point i – point x e (new)
(xe) Support actions to promote the reinforcement of investment in a joint R&D policy;
Amendment 987 #
Proposal for a regulation
Annex I – point i – point x f (new)
Annex I – point i – point x f (new)
(xf) Support the strengthening of investment in instruments for monitoring the commerce and availability of medicines for human use and medical devices, at national and Union level;
Amendment 988 #
Proposal for a regulation
Annex I – point i – point x g (new)
Annex I – point i – point x g (new)
(xg) Support research into possible repurposing of existing drugs, exploring new uses and indications of therapies for existing drugs;
Amendment 989 #
Proposal for a regulation
Annex I – point j – point i
Annex I – point j – point i
(i) Support for the deployment, operation and maintenance of mature interoperable digital service infrastructures and data security and quality assurance processes for data exchange, access, use and reuse; support for cross border networking, including through theimprovement and better use of electronic health records, registries and other databases;
Amendment 997 #
Proposal for a regulation
Annex I – point j – point ii
Annex I – point j – point ii
(ii) Support toinvestments for the digital transformation of health care and health systems including through benchmarking and capacity building for the uptake of innovative tools and technologies; digital upskilling of health care professsionals and citizens;
Amendment 998 #
Proposal for a regulation
Annex I – point j – point iii
Annex I – point j – point iii
(iii) Support the deployment and interoperability of digital tools and infrastructures within and between Member States and with Union Institutions, Agencies and bodies; including support for the implementation of an Electronic European Health Record; develop appropriate governance structures and sustainable, interoperable Union health information systems, as part of the European Health Data Space and strengthen citizens’ access to and control over theirwith a view to the safe and efficient deployment of AI in healthcare; strengthen and facilitate citizens’ access to and control over their health data; support uptake and broader implementation of current successful initiatives and projects on person-centred digital health and health data;
Amendment 1002 #
Proposal for a regulation
Annex I – point j – point iii a (new)
Annex I – point j – point iii a (new)
(iiia) Support actions to promote a European cohesion and coherence policy for digital health in order to harmonize the legal, organizational, semantic and technical components necessary for a functional and efficient cross-border ecosystem;
Amendment 1003 #
Proposal for a regulation
Annex I – point j – point iii b (new)
Annex I – point j – point iii b (new)
(iiib) Support the development of digital tools and digital solutions to increase the use of e-health and improve the sustainability and resilience of healthcare systems;
Amendment 1004 #
Proposal for a regulation
Annex I – point j – point iii c (new)
Annex I – point j – point iii c (new)
(iiic) Support action to scale up cross- border information exchange services and commence the implementation of projects such as Patient Summary and ePrescription;
Amendment 1005 #
Proposal for a regulation
Annex I – point j – point iv
Annex I – point j – point iv
(iv) Support access to and optimal use of telemedicine/telehealth, including through and other e- health tools, including through boosting the coverage of internet and satellite communications for remote areas, foster digitally-driven organisational innovation in healthcare facilities and promote digital tools supporting citizen empowerment, and person-centred care. and self-management of health; promote the involvement of patients in the co-design and co- development of user-friendly tele- medicine and tele-health solutions;
Amendment 1009 #
Proposal for a regulation
Annex I – point j – point iv a (new)
Annex I – point j – point iv a (new)
(iva) Actions to support the involvement of patients and healthcare professionals in the development, design and deployment of user-centred accessible, secure and efficient digital health innovation;
Amendment 1012 #
Proposal for a regulation
Annex I – point k – point iii
Annex I – point k – point iii
(iii) Communication to promote disease prevention andand protect health, prevent disease and promote healthy lifestyles, in cooperation with all concerned actors at international, Union and nat, national and regional level.;
Amendment 1013 #
Proposal for a regulation
Annex I – point k – point iii a (new)
Annex I – point k – point iii a (new)
(iiia) Communication, information and awareness campaigns on blood, organs, tissues and cells donation, that alert the public to the importance of such donation, in terms of solidarity, health policy and therapeutical benefits;
Amendment 1014 #
Proposal for a regulation
Annex I – point k – point iii b (new)
Annex I – point k – point iii b (new)
(iiib) Communication activities aimed at fighting against misinformation and disinformation, such as fake news, regarding medicines, vaccines, health products, causes and treatments of diseases;
Amendment 1015 #
Proposal for a regulation
Annex I – point k – point iii c (new)
Annex I – point k – point iii c (new)
(iiic) Communication addressed to citizens on health risks from environmental and food issues;
Amendment 1018 #
Proposal for a regulation
Annex II – part A – point II a (new)
Annex II – part A – point II a (new)
IIa. Review existing fast-track flexibilities in the Union approval framework and support pragmatic clinical trials
Amendment 1019 #
Proposal for a regulation
Annex II – part A – point III
Annex II – part A – point III
III. Number of actions and best practices directly contributing to the SDG 3.4/Member StateUniversal Health Care (UHC) service coverage index
Amendment 1021 #
Proposal for a regulation
Annex II – part A – point IV
Annex II – part A – point IV
IV. Implementation of best practichealth programmes by EU Member States that promote health and prevent diseases
Amendment 1023 #
Proposal for a regulation
Annex II – part A – point IV a (new)
Annex II – part A – point IV a (new)
IVa. Unmet needs in terms of the access to centrally authorised medicines, vaccines or medical devices, due to the lack of affordability, availability and time
Amendment 1024 #
Proposal for a regulation
Annex II – part A – point IV b (new)
Annex II – part A – point IV b (new)
IVb. Universal Health Care (UHC) service coverage index
Amendment 1026 #
Proposal for a regulation
Annex II – part B – point 1 a (new)
Annex II – part B – point 1 a (new)
1a. Number of strategic reserves of medicines, vaccines, medical devices and other medical products
Amendment 1027 #
Proposal for a regulation
Annex II – part B – point 1 b (new)
Annex II – part B – point 1 b (new)
1b. Number of strategic reserves of health professionals with training and preparedness to respond to health threats and health crises
Amendment 1028 #
Proposal for a regulation
Annex II – part B – point 1 c (new)
Annex II – part B – point 1 c (new)
1c. Unmet needs in terms of medicines, vaccines, medical devices, due to the lack of availability, affordability or time
Amendment 1029 #
Proposal for a regulation
Annex II – part B – point 1 d (new)
Annex II – part B – point 1 d (new)
1d. The ratio of new medicines or vaccines in the market compared to the number of clinical trials in the Union and per Member State
Amendment 1030 #
Proposal for a regulation
Annex II – part B – point 1 e (new)
Annex II – part B – point 1 e (new)
1e. Universal Health Care (UHC) service coverage index
Amendment 1031 #
Proposal for a regulation
Annex II – part B – point 1 f (new)
Annex II – part B – point 1 f (new)
1f. Creation of the European Health Data Space (EHDS)
Amendment 1032 #
Proposal for a regulation
Annex II – part B – point 1 g (new)
Annex II – part B – point 1 g (new)
1g. Coverage of citizens with access to their data on the EHDS, per Member State
Amendment 1033 #
Proposal for a regulation
Annex II – part B – point 1 h (new)
Annex II – part B – point 1 h (new)
1h. Number of breaches of security of the EHDS
Amendment 1034 #
Proposal for a regulation
Annex II – part B – point 1 i (new)
Annex II – part B – point 1 i (new)
1i. Coverage of health professionals with digital skills, per Member State
Amendment 1035 #
Proposal for a regulation
Annex II – part B – point 1 j (new)
Annex II – part B – point 1 j (new)
1j. Coverage of citizens having the digital skills necessary to use e-health technology, per Member State
Amendment 1036 #
Proposal for a regulation
Annex II – part B – point 1 k (new)
Annex II – part B – point 1 k (new)
1k. Number of health promotion programmes implemented per Member State, based on health issues covered, using the WHO International Classification of diseases (ICD10)
Amendment 1037 #
Proposal for a regulation
Annex II – part B – point 1 l (new)
Annex II – part B – point 1 l (new)
1l. Coverage of workers with access to occupational healthcare services, per Member State
Amendment 1038 #
Proposal for a regulation
Annex II – part B – point 1 m (new)
Annex II – part B – point 1 m (new)
1m. Ratio of environmental health assessments compared to the number of medicines, vaccines and medical devices that entered into the market
Amendment 1039 #
Proposal for a regulation
Annex II – part B – point 1 n (new)
Annex II – part B – point 1 n (new)
1n. Vaccination coverage, by vaccine- preventable-disease, age and sex
Amendment 1040 #
Proposal for a regulation
Annex II – part B – point 1 o (new)
Annex II – part B – point 1 o (new)
1o. Number of Member States that implemented the European Electronic Health Record while providing stronger guarantees for personal data protection
Amendment 1041 #
Proposal for a regulation
Annex II – part B – point 1 p (new)
Annex II – part B – point 1 p (new)
1 p. Age-standardised five-year net survival of cancer, in total, by type of cancer, gender and age
Amendment 1042 #
Proposal for a regulation
Annex II – part B – point 1 q (new)
Annex II – part B – point 1 q (new)
1q. Ratio of Cancer Registries (CRs) to number of Member States (MSs) reporting information of the cancer stage at diagnosis
Amendment 1043 #
Proposal for a regulation
Annex II – part B – point 1 r (new)
Annex II – part B – point 1 r (new)
1r. Age-standardized DALYs attributable to the NCDs (per 100 000 people), by disease, gender and age
Amendment 1044 #
Proposal for a regulation
Annex II – part B – point 1 s (new)
Annex II – part B – point 1 s (new)
1s. Age-standardized NCD mortality rate (per 100 000 people), by disease, by gender and age
Amendment 1045 #
Proposal for a regulation
Annex II – part B – point 1 t (new)
Annex II – part B – point 1 t (new)
1t. Age-standardized deaths attributable to the environment (per 100 000 people) by gender and age
Amendment 1046 #
Proposal for a regulation
Annex II – part B – point 1 u (new)
Annex II – part B – point 1 u (new)
1u. Number of medical doctors (per 10 000 people), by Member State and region
Amendment 1047 #
Proposal for a regulation
Annex II – part B – point 1 v (new)
Annex II – part B – point 1 v (new)
1v. Number of nurses (per 10 000 people), by Member State and region
Amendment 1048 #
Proposal for a regulation
Annex II – part B – point 1 w (new)
Annex II – part B – point 1 w (new)
1w. Number of healthcare professionals (per 10 000 people), by Member State and region
Amendment 1049 #
Proposal for a regulation
Annex II – part B – point 1 x (new)
Annex II – part B – point 1 x (new)
1x. Age-standardised obesity prevalence, by gender and age
Amendment 1050 #
Proposal for a regulation
Annex II – part B – point 1 y (new)
Annex II – part B – point 1 y (new)
1 y. Age-standardised prevalence of people who are overweight, by gender and age
Amendment 1051 #
Proposal for a regulation
Annex II – part B – point 1 z (new)
Annex II – part B – point 1 z (new)
1z. Age-standardised harmful use of alcohol prevalence, by gender and age
Amendment 1052 #
Proposal for a regulation
Annex II – part B – point 1 aa (new)
Annex II – part B – point 1 aa (new)
1aa. Age-standardised gambling prevalence, by gender and age
Amendment 1053 #
Proposal for a regulation
Annex II – part B – point 1 ab (new)
Annex II – part B – point 1 ab (new)
1ab. Age-standardised proportion of citizens who do not exercise, by gender and age
Amendment 1054 #
Proposal for a regulation
Annex II – part B – point 1 ac (new)
Annex II – part B – point 1 ac (new)
1ac. Proportion of HIV/AIDS patients with access to adequate treatment, by gender and age
Amendment 1055 #
Proposal for a regulation
Annex II – part B – point 1 ad (new)
Annex II – part B – point 1 ad (new)
1ad. Proportion of Tuberculosis patients with access to adequate treatment, by gender and age
Amendment 1056 #
Proposal for a regulation
Annex II – part B – point 1 ae (new)
Annex II – part B – point 1 ae (new)
1ae. Proportion of viral hepatitis patients with access to adequate treatment, by gender and age
Amendment 1057 #
Proposal for a regulation
Annex II – part B – point 1 af (new)
Annex II – part B – point 1 af (new)
1af. Maternal mortality ratio (per 100 000 live births)
Amendment 1058 #
Proposal for a regulation
Annex II – part B – point 1 ag (new)
Annex II – part B – point 1 ag (new)
1ag. Infant mortality rate (per 100 000 live births);
Amendment 1071 #
Proposal for a regulation
Annex II – part B – point 8
Annex II – part B – point 8
8. Smoking prevalencAge-standardised smoking prevalence, by gender and age
Amendment 1091 #
Proposal for a regulation
Annex II – part B – point 14 a (new)
Annex II – part B – point 14 a (new)
14a. Number of health impact assessments of Union policies
Amendment 1095 #
Proposal for a regulation
Annex II – part B a (new)
Annex II – part B a (new)
Ba. Age-standardized QALYs attributable to the NCDs (per 100 000 people), by disease, gender and age