Activities of Cristian-Silviu BUŞOI related to 2020/0102(COD)
Plenary speeches (2)
Programme for the Union's action in the field of health for the period 2021-2027 (“EU4Health Programme”) (debate)
Programme for the Union’s action in the field of health for the period 2021-2027 (‘EU4Health programme’) (debate)
Reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the establishment of a Programme for the Union's action in the field of health –for the period 2021-2027 and repealing Regulation (EU) No 282/2014 (“EU4Health Programme”)
Amendments (95)
Amendment 142 #
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, as well as a permanent structured and coordinated dialogue between authorities and relevant stakeholders, in order to improve the prevention and control of the spread of severe human diseases across borders, to combat other serious cross- 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 148 #
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 to respond to existing epidemics taking into consideration regional and national specificities and have the capacity to face future worrying realities and health threats, such as pandemics and cross-border threats, including antimicrobial resistance and the health impacts of the climate crisis. The Union shall support Member States in reducing health inequalities and in achieving universal health coverage, addressing the challenges of an ageing population, of chronic diseases, or disease prevention, in promoting a healthy lifestyle, prevention services and preparing their health systems for emerging technologies.
Amendment 162 #
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 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 176 #
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 stockpilingEU reserve 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 184 #
Proposal for a regulation
Recital 12
Recital 12
(12) With a view to protect people in vulnerable situations, including those suffering from mental illnesses, living with or most affected by communicable or non- communicable diseases and chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups, including improving health literacy and supporting patient advocacy groups. With a view to guaranteeing continued high standards of essential healthcare services, including prevention, the Programme should, in particular in times of crisis and pandemics, encourage a transition to accessible and affordable telemedicine, at-home administration of medication and implementation of preventative and self-care plans, where possible and appropriate, while ensuring that access to healthcare and prevention services is provided to chronic patients and patients at risk. The Programme should also ensure that the transition is based on evidence and evaluation of best practices, supported by adequate systems of information and health literacy, infrastructures and careful planning, taking into consideration issues such as access to digital solutions in remote areas or for specific population groups.
Amendment 222 #
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, 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. The development of a European health data space and of a European Electronic Health Record would provide health care systems, researchers and public authorities with means to improve the availability and quality of healthcareccessibility, availability, affordability and quality of healthcare. The Programme must ensure, in setting up the European Health Data Space, adequate resources for ECDC/ national agencies to collect data on diagnosis, care and outcomes. It must also provide resources and integrate data collected by civil society. 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. , clear and easy to understand and exercise by patients and adapted to innovation and new technologies. __________________ 12Council Conclusions on Common values and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1).
Amendment 227 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) The COVID-19 situation has taught us the importance of health as a public good which needs to be preserved by developing coherent approaches to tackle chronic conditions, be they communicable or non-communicable, and by exploiting synergies in approaching people at risk. The COVID- 19 situation has also highlighted the imperative to generate and share reliable data on diagnosis, treatment and cure via the ECDC across the EU. It has also confirmed the need to apply innovative solutions to identify people at risk of having an infectious disease, so they can be tested, linked to care and take precautions to prevent further transmissions, leading to disease elimination. Notwithstanding the differences in transmission routes, these learnings also apply to viral hepatitis, where the ECDC report from May 2020 which monitors progress towards the elimination of hepatitis B and C in the EU/EEA highlights that “hepatitis related mortality is high in the region and there is very little evidence of progress towards the 2030 elimination target of a 65% reduction in mortality against the 2015 baseline". The ECDC report thus confirms that, unless the EU drives forward the prevention of transmission, diagnosis and linkage to care, Europe will fail to meet the WHO elimination target and will fail to deliver on its commitment to the UN SDG.
Amendment 232 #
Proposal for a regulation
Recital 15 b (new)
Recital 15 b (new)
(15b) Generating and sharing reliable data on health systems’ management of communicable diseases is essential to track the progress made and tailor national and local systems’ responses across Europe in a coordinated manner. The Programme should therefore support the upscaling of the ECDC’s competence and resources in monitoring health care systems’ responses to transmittable diseases, including HIV, TB and viral hepatitis. In particular, additional resources should be channelled to support the creation of EU-wide databases, with the aim to provide an overview of the existing gaps in the continuum of care. EU-wide data sharing should also help monitor the management of such conditions in the long-term and from a holistic perspective, including the management of relevant comorbidities and the overall progress of the system in improving the health-related quality of life of patients.
Amendment 235 #
Proposal for a regulation
Recital 15 c (new)
Recital 15 c (new)
(15c) Ensuring a fit for purpose regulatory environment is a key element to protect public health, provide access to high quality medicines and contribute to the prevention of shortages. The effective use of Information Technology systems will improve regulatory efficiency across Europe; it is important therefore to optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and interdependency of the European regulatory framework.
Amendment 239 #
Proposal for a regulation
Recital 16
Recital 16
(16) Keeping people healthy and active longer and empowering them to take an active role in managing their health, by improving their health literacy, will have positive effects on health, health inequalities, quality of life, productivity, competitiveness and inclusiveness, while reducing pressures on national budgets. The Commission has committed to help Member States to reach the sustainable development targets set in the 'UN 2030 Agenda for Sustainable Development’ in particular Sustainable Development Goal 3 "Ensure healthy lives and promote well- being for all at all ages".13 The Programme therefore should contribute to the actions taken towards reaching these goals, for e.g. by recognizing the strategic role of health literacy in managing personal health. __________________ 13Communication from the Commission to the European Parliament, the Council, the 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 265 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) In the implementation of those prevention, vaccination, early diagnosis and screening strategies, it is imperative that the Programme exploit synergies with the ESF+ and other programmes.
Amendment 268 #
Proposal for a regulation
Recital 17 b (new)
Recital 17 b (new)
(17b) The role of primary prevention and health promotion is key to address long term, common European challenges such as non-communicable and communicable diseases, ageing and cross- border health threats such as future pandemics or health crises, and antimicrobial resistance. The Union can bring additional added-value to offer an overall public health strategy based on identified best practices and the European dimension of identified health challenges in the area of access to healthcare, health prevention and promotion in order to reduce health inequalities and health differences in Europe.
Amendment 273 #
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 factorsdeterminants of health, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugdrugs and psychoactive substances. The Programme should also contribute to the reduction of drugs-related health damage, obesity and unhealthy dietary habits and physical inactivity, and exposure to environmental pollution, and foster health supportive environments for healthy lifestyles in order to complement Member States action in these areas. The Programme therefore should contribute to a high level of human health protection and prevention, throughout the entire lifetime of an individual, including through the promotion of physical activity, nutritional care and promotion of health education. The Programme should also strengthen and support EU health related legislation, including in the area of environmental health, and foster Health in All Policies. The Programme should also therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.
Amendment 287 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18a) A holistic long-term health care approach is necessary in view of the growing prevalence of chronic diseases among an ageing EU population. As many conditions that were once fatal, such as HIV, increasingly become chronic and manageable conditions thanks to innovative treatments, healthcare systems need to adapt and provide a comprehensive model of care that takes into account the specific needs of people affected by chronic diseases, thereby improving their health-related quality of life. The Programme should support the development of integrated systems of care that allow for multidisciplinary, cross-disease cooperation between health practitioners in order to ensure that people living with chronic diseases receive adequate support, including in the management of co- morbidities and other health-related issues, such as mental health conditions.
Amendment 292 #
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 from the onset, if detected early, or helping patients feel their best and remain active for longer. The Union and the Member States can therefore greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, including prevention and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines in the area of both communicable and non- communicable diseases, such as cardiovascular diseases, neurodegenerative diseases, cancer, respiratory diseases and diabetes.
Amendment 298 #
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 non-communicable diseases that share common risk factors and the prevention and control of which would benefit the majority of citizens. Currently no broadly accepted tools such as a “Cancer Dashboard” exist which can serve to measure progress (e.g. EU Cancer Targets) and address inequalities (e.g. in Central and South-Eastern Europe versus the rest of Europe). In 2020 the Commission announced the ‘Europe’s Beating Cancer Plan’ which would cover the entire cycle of the disease starting from prevention and early diagnosis to treatment and quality of life of patients and survivors. The measures should benefit from the Programme and from Horizon Europe’s Mission on Cancer, in particular by initiatives which support the mid- and long-term goals of the Plan. The actions on cancer should equally address its common shared risk factors and synergies with other major non-communicable diseases such as neurological disorders, as well as reflect upon devising a template for other major disease areas based on the ‘Europe’s Beating Cancer Plan’.
Amendment 309 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) A recent study by authors from IARC published in the February 2020 edition of the Lancet Global Health Journal, highlights a crucial need for resources directed towards cancer prevention programmes that target infection, namely helicobacter pylori, human papillomavirus, Hepatitis B virus and Hepatitis C virus, particularly in high-risk populations. Such interventions can markedly reduce the increasing cancer burden and associated mortality. The Programme should just ensure that will promote measures to tackle infectious diseases, helping their prevention, through vaccination, if available, awareness raising, early diagnosis/screening, and linkage to care, with a view to promoting the prevention of cancer as a key European Commission goal.
Amendment 316 #
Proposal for a regulation
Recital 19 b (new)
Recital 19 b (new)
(19b) The IARC shows that more than 35,000 children and young people are diagnosed with cancer and over than 6,000 young patients die annually in Europe. Paediatric cancers are a category of age- and biologically specific rare malignancies that cannot be appropriately addressed by extrapolation of adult cancer approaches and require a dedicated effort across the research and care continuum. There is a lack of innovative therapies to treat children with cancer. Even for older off-patent medicines used off-label on children, there are still pronounced access issues including shortages across the Union and budget limitations in some Member States, as well as major differences among countries in pain control accessibility for children undergoing treatment for cancer. Hence, there is an urgent need to appropriately revise the regulatory environment so that the needs of children and adolescents are met. The Programme should therefore provide for actions in this regard, in particular aiming to reinforce Regulation (EC) No 1901/2006 of the European Parliament and of the Council. and support cross-border research collaboration by granting appropriate allocations and to amend Article 10 of the directive 2001/83/EC, in order to include a paragraph to stimulate innovation on the off-patented medicines.
Amendment 342 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitdevelop a single pan-European monitoring, reporting and notification system for shortages of medicines, medical devices and other healthcare products, to avoid fragmentation of the single market and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed upand real world evidence generation to enable the development, authorisation, evaluation and access to innovative and effective new medicines, promote incentives to develop such medicinal products as antimicrobials an. the programme should foster the digitial transformation of healthcare products and platforms for single pan-European monitoring and collecting information on medicines. The Programme should support the implementation of the new Pharmaceutical Strategy for Europe and the work of the EMA.
Amendment 357 #
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22a) Support actions to ensure the implementation of cross-cutting EU policy initiatives aimed at building a sustainable Europe with a high level of human health protection, such as the European Green Deal and its component strategies.
Amendment 368 #
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. The ECDC has estimated that, on average, health care associated infections occur in one hospitalised patient in 20, that is to say 4,1million patients a year in the Union, and that 37 000 deaths are caused every year as a result of such infections. Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. HAI can happen in any healthcare facility, including hospitals, ambulatory surgical centres, end-stage renal disease facilities, and long-term care facilities It is therefore important that the Commission, under the Programme, develops guidelines for preventing HAI, and that the Programme supports investment in modernizing health systems to overcome and reduce HAI and supports interventions to improve patient safety, including the implementation of Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections. European-level collaboration and coordination on patient safety should be enhanced through the creation of a European Network on Patient Safety, supported through the Health Programme and with direct involvement of patients’ organisations.
Amendment 377 #
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 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, including real-world health care data, to underpin policymaking and monitoring, set targets and develop tools to measure progress (e.g. a Cancer Dashboard).
Amendment 447 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) support health promotion, improve health literacy, and disease prevention, reduce health inequalities, improve physical and mental health, protect people in the Union from serious cross-border threats to health;
Amendment 458 #
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 equal availability, accessibility and affordability of health care and services in the Union, including of medicines, medical devices and other crisis relevant products, contribute to treatments and medical devices, support safe and effective use, and boost research and innovation in healthcare; support systematic health impact assessment of otheir affordability, and support innovation;EU policies ensuring a comprehensive, Health in All Policies approach.
Amendment 473 #
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 ands, health literacy, joint health targets, metrics and patients, and comparable data sharing, to increase the general level of public health.
Amendment 505 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Article 4 – paragraph 1 – point 1 a (new)
(1a) support actions aimed at creating and developing a EU Platform for shortages, based on one harmonised data- collection model and national reporting systems of shortages interoperability, including the full implementation of an effective EU telematics infrastructure that will link data on medicine and supply chain data through interconnection of SPOR and FMD system;
Amendment 511 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 b (new)
Article 4 – paragraph 1 – point 1 b (new)
(1b) support actions aimed at modernise and digitalise the EU regulatory Network at European and national level;
Amendment 541 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4 a (new)
Article 4 – paragraph 1 – point 4 a (new)
(4a) enhance the equal and timely access to quality, sustainable and affordable person-centred preventive and curative health care and related care and services for all;
Amendment 547 #
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 disease prevention and health promotion, early diagnosis and screening, and implement health promotion, including through the promotion of physical activity, health literacy, patient rights and cross-border healthcare, and promote the excellence of medical and healthcare professionals;
Amendment 559 #
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 cancer, while addressing its synergies with other major non- communicable diseases such as neurological disorders; the programme should support the implementation of Europe's Beating Cancer Plan;
Amendment 560 #
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 cancer; by providing a European strategies Chronic disease framework to support Member States action, while addressing its synergies with other major non-communicable diseases such as neurological disorders.
Amendment 581 #
Proposal for a regulation
Article 4 – paragraph 1 – point 8
Article 4 – paragraph 1 – point 8
(8) support the development, implementation and enforcement of Union health legislation and provide high-quality, comparable and reliable data to underpin policy making and monitoring, and promote the use of health impact assessments of relevant policies, as well as dashboards with key metrics to measure progress and reducing inequalities, notably in cancer;
Amendment 596 #
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 to drive forward the prevention, diagnosis and linkage to care, thus helping Europe to deliver on the UN SDGs. These networks should work in close cooperation with civil society and also collect much needed data and contribute to the European Health Data Space. This way, they will help monitor progress towards the fight and towards the elimination of these diseases in line with WHO and UN Goals;
Amendment 638 #
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 plans established for the Programme and its priorities and strategic orientations and its implementation, as well as relevant Union decentralised agencies, theEU4Health Steering Board and other relevant stakeholders, such as representatives of civil society organisations, in particular patients’ organisations, on the work plans established for the Programme and its priorities and strategic orientations and its implementation. Promoting synergies between European funds and national funds/resources shall be considered to ensure long-term effectiveness and sustainability of actions.
Amendment 661 #
Proposal for a regulation
Annex I – point a – point ii a (new)
Annex I – point a – point ii a (new)
(iia) Development of a single pan- European digital mechanism for better reporting, notifying and monitoring of potential shortages, by starting from supporting the implementation of a European common data repository and interconnection between regulatory information on medicines, contained in SPOR, with supply chain data, in FMD system, in all Member States;
Amendment 674 #
Proposal for a regulation
Annex I – point c – point i
Annex I – point c – point i
(i) Surveys, studies, centralized and accessible collection of data and statistics, methodologies, classifications, microsimulations, pilots, indicators, knowledge brokering and benchmark exercises;
Amendment 677 #
Proposal for a regulation
Annex I – point c – point iii
Annex I – point c – point iii
(iii) Expert groups and panels, including all relevant stakeholders, providing advice, evaluation, data and information to support health policy development and implementation; such expert groups and panels should include representatives of patients and other relevant civil society organisations;
Amendment 690 #
Proposal for a regulation
Annex I – point c – point iii a (new)
Annex I – point c – point iii a (new)
(iiia) Setting up and management of a High Level Pharmaceuticals Forum at political level composed of authorities and relevant health stakeholders to define priorities and concrete measures to be implemented at technical level;
Amendment 695 #
Proposal for a regulation
Annex I – point c – point iv
Annex I – point c – point iv
(iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on "Consumer Safety" and on "Health, Environmental and Emerging Risks". and on "Healthcare systems performance"
Amendment 701 #
Proposal for a regulation
Annex I – point d – introductory part
Annex I – point d – introductory part
(d) DEvaluation, development and implementation of Union health legislation and action for the protection and promotion of health, in particular through support to:
Amendment 708 #
Proposal for a regulation
Annex I – point d – point i
Annex I – point d – point i
(i) IDevelopment, implementation, enforcement, monitoring of Union health legislation and actionincluding Pharmacovigilance legislation, and relative action for the protection and promotion of health; and technical support to thean harmonised implementation of legal requirementand operational requirements across Member States;
Amendment 717 #
Proposal for a regulation
Annex I – point d – point iv
Annex I – point d – point iv
(iv) Development and, operation and maintenance of databases and digital tools and their interoperability, including already established project such as creation of a central common repository for all medicines in Europe and SPOR implementation, including where appropriate with other sensing technologies, such as space-based;
Amendment 724 #
Proposal for a regulation
Annex I – point d – point v
Annex I – point d – point v
(v) Auditing and, assessment and inspection work in accordance with Union legislation;
Amendment 737 #
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 EU policy action;
Amendment 739 #
Proposal for a regulation
Annex I – point d – point xi b (new)
Annex I – point d – point xi b (new)
(xib) Population information and awareness campaigns and stakeholder-led projects.
Amendment 750 #
Proposal for a regulation
Annex I – point e – point iv
Annex I – point e – point iv
(iv) Procurement of goods and services, including MEAT criteria, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 757 #
Proposal for a regulation
Annex I – point f – point ii a (new)
Annex I – point f – point ii a (new)
(iia) Support tools and platforms to collect real-world data on the safety, effectiveness and impact of vaccines after use while guaranteeing robust evidence generation in the pre-approval phase;
Amendment 760 #
Proposal for a regulation
Annex I – point f – point iii
Annex I – point f – point iii
(iii) Support and/or procure emergency production of medical countermeasures, including essential chemicals and active substances, and the financing of cooperation on emergency health technology assessments and clinical trials; and secure financing of exceptional measures to free capacity of lines that can be utilised to provide ICU medicines;
Amendment 763 #
Proposal for a regulation
Annex I – point f – point iv
Annex I – point f – point iv
(iv) Preventive actions to protect vulnerable groups from health threats and actions to adjust the response to and management of crisis to the needs of those vulnerable groups, with the commitment to leave no one behind, such as while safeguarding continued access to quality care and patient safety, and securing basic care for non-communicable and chronic disease patients, including for those in need of palliative care and pain management treatment;
Amendment 770 #
Proposal for a regulation
Annex I – point f – point v a (new)
Annex I – point f – point v a (new)
(va) While keeping patient safety a top priority, actions to facilitate the availability of accessible and affordable telemedicine services throughout Europe to all patients, support digital literacy and a transition to telemedicine, at-home administration of treatment and medication and implementation of preventative and self-care plans, while involving patients’ organisations in evaluating, identifying and implementing the best possible solutions to continued access to quality care and treatment;
Amendment 774 #
Proposal for a regulation
Annex I – point f – point v b (new)
Annex I – point f – point v b (new)
(vb) Actions to support harmonised implementation of electronic product information in all Members States , transition to telemedicine, at-home administration of medication and implementation of preventative and self- care plans, where possible and appropriate;
Amendment 779 #
Proposal for a regulation
Annex I – point f – point viii
Annex I – point f – point viii
(viii) Actions to support investigation, risk assessment and risk management work related to all medicinal products but with focus to priority, science and current taking into account existing knowledge on the link between animal health, environmental factors, and human diseases, including during health crises.
Amendment 782 #
Proposal for a regulation
Annex I – point f – point viii a (new)
Annex I – point f – point viii a (new)
(viiia) Actions to support better crisis management for critical medicines, including the creation, development of an EU central portal to monitoring shortages and an effective EU telematics infrastructure to make data on medicine and supply chain data interoperable via the full implementation of SPOR and connection to the FMD system;
Amendment 791 #
Proposal for a regulation
Annex I – point f – point viii b (new)
Annex I – point f – point viii b (new)
(viiib) Actions to secure continuity of care and treatment and in particular of chronic conditions during health crisis;
Amendment 794 #
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, while linking available EU funding, in particular to address the challenges identified by the European Semester and Country Specific Recommendations on health, and to strengthen primary care, reinforce the integration of care and aim at universal health coverage and equal access to healthcare;
Amendment 808 #
Proposal for a regulation
Annex I – point g – point vi a (new)
Annex I – point g – point vi a (new)
(via) Improve the current EU monitoring system to measure the extent of healthcare exclusion, collect data and report publicly on access barriers experienced by patients, and develop more accurate indicators where needed to capture these;
Amendment 812 #
Proposal for a regulation
Annex I – point g – point ix
Annex I – point g – point ix
(ix) Support the establishment and implementation of programmes and in particular digital and evidence-based programmes assisting Member States and their action to improve health promotion, health literacy and disease prevention (for communicable and non-communicable diseases) in hospitals and communities;
Amendment 821 #
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 healthy diets taking into account the needs of vulnerable groups. Reduce inequalities in health literacy of patients and citizens by including health literacy in European and national health strategies, e.g. including Europe’s Beating Cancer Plan and National Cancer Control Plans;
Amendment 824 #
Proposal for a regulation
Annex I – point g – point xi
Annex I – point g – point xi
(xi) Support the functioning of the European Reference Networks and the establishment and operation of new transnational networks set out in accordance with Union health legislation, such as upscaling ERNs and expanding to other chronic disease areas, and support Member States’ actions to coordinate the activities of these networks with the operation of national health systems;
Amendment 830 #
Proposal for a regulation
Annex I – point g – point xii a (new)
Annex I – point g – point xii a (new)
(xiia) Support the development and implementation of programmes assisting Member States to improve their generic and biosimilar use to increase healthcare system efficiency;
Amendment 854 #
Proposal for a regulation
Annex I – point h – point i
Annex I – point h – point i
(i) Support Member States, IARC and NGOs in the promotion and implementation of the recommendations of the European Code against Cancer;
Amendment 856 #
Proposal for a regulation
Annex I – point h – point i a (new)
Annex I – point h – point i a (new)
(ia) Support the revision and continuous update of the current edition of the European Code against Cancer accompanied by a systematic evaluation of the impact of the European Code against Cancer;
Amendment 864 #
Proposal for a regulation
Annex I – point h – point iii
Annex I – point h – point iii
(iii) Support prevention programmes on the main cancer risk factors that are of demonstrated effectiveness and supported by established evidence;
Amendment 870 #
Proposal for a regulation
Annex I – point h – point iv a (new)
Annex I – point h – point iv a (new)
(iva) Ensure the continuous monitoring and evaluation of Council Recommendation on cancer screening (2003) enabling links to the European Cancer Information System and European Network of Cancer Registries;
Amendment 873 #
Proposal for a regulation
Annex I – point h – point iv b (new)
Annex I – point h – point iv b (new)
(ivb) Actions to support the implementation of the WHO Global Call for the Elimination of Cervical Cancer;
Amendment 886 #
Proposal for a regulation
Annex I – point h – point v a (new)
Annex I – point h – point v a (new)
(va) Actions supporting access to the standard of cancer treatment and care;
Amendment 893 #
Proposal for a regulation
Annex I – point h – point vi a (new)
Annex I – point h – point vi a (new)
(via) Support the establishment of a Cancer Dashboard to reduce systemic health inequalities and improve patient access to cancer care, with a focus on prevention, screening, early diagnosis, access to cancer diagnosis and treatment;
Amendment 912 #
Proposal for a regulation
Annex I – point h – point x a (new)
Annex I – point h – point x a (new)
(x a) Actions to support addressing common shared risk factors and synergies that cancer has with other major non- communicable diseases such as neurological disorders, as well as making EU cancer plan a template for other major disease areas;
Amendment 919 #
Proposal for a regulation
Annex I – point h – point x b (new)
Annex I – point h – point x b (new)
(xb) Promote use of MEAT criteria in procurement mechanisms to enhance safe and timely usage of generic and biosimilar medicines in cancer care;
Amendment 924 #
Proposal for a regulation
Annex I – point h – point x c (new)
Annex I – point h – point x c (new)
(xc) actions to promote health and safety for healthcare workers involved in cancer treatment;
Amendment 931 #
Proposal for a regulation
Annex I – point i – point ii a (new)
Annex I – point i – point ii a (new)
(iia) Support actions to promote the use of generic and biosimilar medicines;
Amendment 938 #
Proposal for a regulation
Annex I – point i – point iii
Annex I – point i – point iii
(iii) Support clinical trials and the use of real world data to speed up the development, authorisation and a pan EU access to innovative, safe and effective medicines and vaccines;
Amendment 943 #
Proposal for a regulation
Annex I – point i – point iv a (new)
Annex I – point i – point iv a (new)
(iva) Support action to strengthen the regulatory framework in the Union to encourage the discovery and development of medicines and vaccines to meet the patient and public health needs and guaranteed the efficacy and safety of newly approved products;
Amendment 954 #
Proposal for a regulation
Annex I – point i – point v a (new)
Annex I – point i – point v a (new)
(va) Support actions to foster innovation on in repurposing, reformulation and combinations of off- patent medicines that that deliver relevant improvements for patients, healthcare professionals and/or healthcare systems;
Amendment 957 #
Proposal for a regulation
Annex I – point i – point v b (new)
Annex I – point i – point v b (new)
(vb) Action to sustain a strong intellectual property framework, incentives and reward mechanisms for R&D, in order to attract investments in the Union for the development of the next generation of medicines, vaccines and medical devices;
Amendment 959 #
Proposal for a regulation
Annex I – point i – point vi
Annex I – point i – point vi
(vi) Support action to monitor, prevent, manage, report and notify shortages of medicines and medical devices occurring in hospitals and community pharmacies, to collect reported shortages in a centralized database, interoperable with databases that contained regulatory data on medicines, to address such shortages, and to increase security of supplies;
Amendment 965 #
Proposal for a regulation
Annex I – point i – point vii
Annex I – point i – point vii
(vii) Support actions to encourage the development of innovative medicines and medical devices less harmful for the environment and promote greener manufacturing and reward investments in procurement processes;
Amendment 967 #
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 to centrally collect and provide access to relevant stakeholders to all known environmental risk assessment data in a uniform way, avoiding unnecessary duplications; including the use of raw materials and impact of REACH on the supply chain using alternate production methods to circumvent processes eg enzymic and using reg flex to be able to commercialise as well as using alternate technology to deliver safer solutions whilst encouraged through purchasing incentives;
Amendment 973 #
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 antimicrobialmedicinal products, including antimicrobials; create technology incentives to neutralise waste in manufacturing plants;
Amendment 977 #
Proposal for a regulation
Annex I – point i – point x
Annex I – point i – point x
(x) Support action to foster international development and regulatory convergence and reliance on medicines and medical devices. and to improve regulatory oversight;
Amendment 990 #
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 994 #
Proposal for a regulation
Annex I – point j – point ii
Annex I – point j – point ii
(ii) Support toinvestment for the digital transformation of health care and health systems including through health systems digital health receptivity research, benchmarking and capacity building for the uptake of innovative tools and technologies; digital upskilling of health care professsionals, as part of a strategy on the health workforce, and citizens, through enhanced education, training and (digital) health literacy measures;
Amendment 999 #
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 theirin view of safe and efficient deployment of AI in health care; 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 1007 #
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 satellite communication for remote areas, foster digitally-driven organisational innovation in healthcare facilities and promote digital tools supporting citizen empowerment and person-centred care.; promote involvement of patients in the co- design and co-development of user- friendly telemedicine/telehealth solutions;
Amendment 1008 #
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 health care professionals in the development, design and deployment of user-centred accessible, secure and efficient digital health innovation;
Amendment 1011 #
Proposal for a regulation
Annex I – point k – point ii a (new)
Annex I – point k – point ii a (new)
(iia) Communication campaign and awareness raising addressed to citizens and stakeholders to promote trust in generic and biosimilar medicines;
Amendment 1020 #
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 and SDG 10/Member State
Amendment 1022 #
Proposal for a regulation
Annex II – part A – point IV
Annex II – part A – point IV
IV. Implementation of best practices by EU Member States addressing health inequalities (SDG 10)
Amendment 1070 #
Proposal for a regulation
Annex II – part B – point 8
Annex II – part B – point 8
8. Smoking prevalenceAge-standardized prevalence of current tobacco use among persons aged 15 years and older [SDG 3.a.1]
Amendment 1073 #
Proposal for a regulation
Annex II – part B – point 8 a (new)
Annex II – part B – point 8 a (new)
8a. Percentage of adults (aged 18+) classified as overweight or obese
Amendment 1080 #
Proposal for a regulation
Annex II – part B – point 8 b (new)
Annex II – part B – point 8 b (new)
8b. Common and shared approach to shortages reporting, notification and definition, reflecting the real impact on patients
Amendment 1086 #
Proposal for a regulation
Annex II – part B – point 14 a (new)
Annex II – part B – point 14 a (new)
14a. ECDC reports on progress on elimination of viral hepatitis, HIV/ AIDS and Tuberculosis in line with WHO Strategies and UN SDGs
Amendment 1092 #
Proposal for a regulation
Annex II – part B – point 14 b (new)
Annex II – part B – point 14 b (new)
14b. Avoidable deaths attributed to cardiovascular disease, cancer, diabetes & chronic respiratory disease for persons aged less than 75 years [SDG 3.4.1]
Amendment 1093 #
Proposal for a regulation
Annex II – part B – point 14 c (new)
Annex II – part B – point 14 c (new)
14c. Total alcohol per capita (age 15+ years) consumption [SDG 3.5.2]
Amendment 1094 #
Proposal for a regulation
Annex II – part B – point 14 d (new)
Annex II – part B – point 14 d (new)
14d. Screening coverage (by examination & invitation) for breast, cervical and colorectal cancer screening programmes