Activities of Kateřina KONEČNÁ related to 2020/0102(COD)
Plenary speeches (1)
Programme for the Union's action in the field of health for the period 2021-2027 (“EU4Health Programme”) (debate)
Shadow 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 (44)
Amendment 180 #
Proposal for a regulation
Recital 11
Recital 11
(11) As iIn the time of health crisis emergency hClinical Trials and Health tTechnology aAssessment as well as clinical trials(HTA) can contribute to the rapid development of medical countermeasures the Programme should provide support to facilitate such actions. The Commission has adopted a proposal11 on Health Technology Assessment (HTA) to support cooperation on health technology assessment at Union level. __________________ 11Proposal for a Regulation of the European Parliament and of the Council on heal, identification and availability of medical countermeasures. The Commission has presented, in January 2018, a Proposal for a Regulation to support cooperation on HTA at Union level. The European Parliament already provided its position expressing a large support for the Proposal, which is awaiting the position and approval of the European Council. A cooperation among Member States has been running for more than 20 years on a voluntary basis. The Commission Proposal aims at making this coordination fully operational and sustainable under the EU budget. The Proposal profiles the creation of a permanent secretariat (also known as Coordination Group) to support Member States cooperation in the timely identification and assessment of relevant health technologies, so as to ensure the necessary transparency and consistency on the medical and scientific information to be made available to Member States, with the due involvement of experts and patients. The programme should provide support to facilitate such actions, including the creation of a scientific committee to advise the HTA Coordination Group of Member States on the technology assessment and amending Directive 2011/24/EU, COM(2018) 51 final of 31.01. 2018ies which are meant to benefit the most from a common assessment. Medical and scientific evidence must override any national administrations’ political or industrial interests.
Amendment 185 #
Proposal for a regulation
Recital 12
Recital 12
(12) With a view to protect people in vulnerable situations, including those suffering from mental illnesses, 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. With a view to guaranteeing continued high standards of essential healthcare services, the Programme should, in particular in times of crisis and pandemics, encourage a transition to telemedicine, at-home administration of medication and implementation of preventative and self-care plans, where possible and appropriate, while ensuring that access to healthcare services is provided to chronic patients. The Programme should also ensure that the transition is based on evidence and evaluation of best practices, supported by adequate systems of information and health literacy, infrastructures and careful planning, taking into consideration issues such as access to digital solutions in remote areas or for specific population groups.
Amendment 224 #
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 healthcare. Given the fundamental right to access to preventive healthcare and medical treatment enshrined in Article 35 of the Charter of Fundamental Rights of the European Union and in view to the common values and principles in European Union Health Systems as set out in the Council Conclusions of 2 June 200612 the Programme should support actions ensuring the universality and inclusivity of health care, meaning that no- one is barred access to health care, and those ensuring that patients’ rights, including on the privacy of their data, are duly respected, 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 256 #
Proposal for a regulation
Recital 17
Recital 17
(17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural factors. Such non- communicable diseases as cardiovascular diseases, cancer, neurological disorders, chronic respiratory diseases, and diabetes, represent major causes of disability, ill- health, health- related retirement, and premature death in the Union, resulting in considerable social and economic impacts. To decrease the impact of non- communicable diseases on individuals and society in the Union and reach goal 3 of the Sustainable Development Goals, Target 3.4, to reduce premature mortality from non- communicable diseases by one third by 2030, it is key to provide an integrated response focusing on prevention across sectors and policy fields, combined with efforts to strengthen health systems.
Amendment 301 #
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. 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. 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 346 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor, prevent and manage shortages of medicines, medical devices and other healthcare products and to ensure greater availability and affordability of those products while limiting the dependency of their supply chains on third countries. In particular, in order to address unmet medical needs, the Programme should provide support to clinical trials so as to speed up the development, authorisation and access to innovative and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicines. The Programme should support the implementation of the new Pharmaceutical Strategy for Europe and the work of the EMA.
Amendment 367 #
Proposal for a regulation
Recital 23 a (new)
Recital 23 a (new)
(23a) Health associated infections (‘HAI’) are infections that patients get while receiving healthcare for another condition. The ECDC has estimated that, on average, healthcare associated infections occur in one hospitalised patient in 20, that is to say 4,1 million patients a year in the Union, and that 37 000 deaths are caused every year as a result of such infections. Poor patient safety represents both a severe public health problem and a high economic burden on limited health resources. HAI can happen in any healthcare facility, including hospitals, ambulatory surgical centres, end-stage renal disease facilities, and long-term care facilities It is therefore important that the Commission, under the Programme, develops guidelines for preventing HAI, and that the Programme supports investment in modernizing health systems to overcome and reduce HAI and supports interventions to improve patient safety, including the implementation of Council Recommendation of 9 June 2009 on patient safety, including the prevention and control of healthcare associated infections. European-level collaboration and coordination on patient safety should be enhanced through the creation of a European Network on Patient Safety, supported through the Health Programme and with direct involvement of patients’ organisations.
Amendment 380 #
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, including real-world healthcare data, to underpin policy making and monitoring.
Amendment 461 #
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 their affordability, and support innovationtreatments and medical devices, support safe and effective use, and boost research and innovation in healthcare;
Amendment 475 #
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 andPractice, improvement of health literacy for citizens and patients and comparable data sharing, to increase the general level of public health.
Amendment 526 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3 a (new)
Article 4 – paragraph 1 – point 3 a (new)
(3a) support actions to transform the health sector into a sector that comprises person-centred and outcome-based care and health systems, and where patients are meaningfully involved in the development of solutions and decision making that affect them;
Amendment 529 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3 b (new)
Article 4 – paragraph 1 – point 3 b (new)
(3b) develop a transparent framework for fair and equitable access in the short, medium and long term to maximise societal benefit and patient access whilst avoiding unacceptable impact on healthcare budgets, through an inclusive consultative process led by governments, and set up a High Level Strategic Dialogue co-ordinated by the Commission and the participation of all stakeholders including patient organisations, to reflect on and establish concrete and comprehensive strategies to achieve such a framework;
Amendment 539 #
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, with no discrimination or stigma;
Amendment 546 #
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, patient rights and cross-border healthcare, and promote the excellence of medical and healthcare professionals, early diagnosis and screening, and implement health promotion, including through the promotion of physical activity, health education literacy, patient rights and cross-border healthcare;
Amendment 558 #
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 and supporting the implementation of Europe’s Beating Cancer Plan;
Amendment 595 #
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;
Amendment 619 #
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4a. Where implementation and monitoring of the programme is carried out by civil society, including participation in institutional structures, and while recognising the specific contribution of patients and their organisations to the programme’s objectives, a sustainable funding scheme to ensure the fulfilment of these roles shall be guaranteed.
Amendment 621 #
Proposal for a regulation
Article 9 a (new)
Article 9 a (new)
Article 9a Beneficiaries eligible for grants 1. Grants for the functioning of patient organisations at Union level may be awarded to European patient organisations which comply with all of the following conditions: (a) they are non-governmental, non- profit-making, and have as their primary objectives and activities the promotion and protection of the health, and representation of the community they represent in the European-level policy processes; (b) they are mandated to represent the interests of patients at Union level by organisations in at three fourths of the Member States that are representative, in accordance with national rules or practice, of patient organisations, and that are active at regional or national level.
Amendment 632 #
Proposal for a regulation
Article 14 – paragraph 6 a (new)
Article 14 – paragraph 6 a (new)
6a. Adequate funding shall be ensured to consolidate and expand the ERN model of cross-border healthcare by securing the provision of a range of clinical services through different channels, including online second opinion and specialist advice for patients on treatment and management and virtual “online out- patient” clinics.
Amendment 637 #
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 679 #
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; such expert groups and panels shall include representatives of patients and other relevant civil society organisations;
Amendment 729 #
Proposal for a regulation
Annex I – point d – point ix a (new)
Annex I – point d – point ix a (new)
(ixa) Capacity building activities for, and resourcing of, patient organizations to increase patients’ contribution to designing and implementing health policies;
Amendment 764 #
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 chronic disease patients in need of palliative care and pain management treatment;
Amendment 766 #
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, oin patients suffering fromaddition to social exclusion and financial hardship, often experienced by patients with chronic diseases and other vulnerable groups;
Amendment 769 #
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 795 #
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 atreach universal health coverage and equal access to healthcare;
Amendment 807 #
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 823 #
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 826 #
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 852 #
Proposal for a regulation
Annex I – point h – point i
Annex I – point h – point i
(i) Support Member States, the IARC and NGOs in the promotion and implementation of the recommendations of the European Code against Cancer;
Amendment 857 #
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 869 #
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 872 #
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 876 #
Proposal for a regulation
Annex I – point h – point v
Annex I – point h – point v
(v) Actions supporting access to cancer services and to innovative medicine, including psycho-social support, rehabilitation and palliative care, and to both essential medicines and high quality innovative treatments for cancer;
Amendment 911 #
Proposal for a regulation
Annex I – point h – point x a (new)
Annex I – point h – point x a (new)
(xa) 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 920 #
Proposal for a regulation
Annex I – point h – point x b (new)
Annex I – point h – point x b (new)
(xb) Building on the EU cancer plan, support the establishment of a template for other major diseases areas such as neurological disorders;
Amendment 939 #
Proposal for a regulation
Annex I – point i – point iii a (new)
Annex I – point i – point iii a (new)
(iiia) Support action to ensure greater availability in the Union of medicines and medical devices and contribute to their affordability for patients and health systems;
Amendment 945 #
Proposal for a regulation
Annex I – point i – point iv a (new)
Annex I – point i – point iv a (new)
(iva) Foster a supportive environment for meaningful patient and public involvement in clinical trials, starting with the design phase and ending with dissemination;
Amendment 991 #
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 992 #
Proposal for a regulation
Annex I – point j – point i a (new)
Annex I – point j – point i a (new)
(ia) Actions to ensure that Electronic Health Records are designed for the support of clinical care and research and to support National health systems in ensuring the integration with the patient registries and the incorporation of EHR data into those registries;
Amendment 993 #
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, 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 1000 #
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 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 1006 #
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 1010 #
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;