Activities of Michèle RIVASI 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)
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 (78)
Amendment 129 #
Proposal for a regulation
Recital 5 a (new)
Recital 5 a (new)
(5a) On 11 March 2020 the World Health Organization (WHO) declared the novel SARS-CoV-2coronavirus and associated respiratory disease (COVID- 19) outbreak a global pandemic. That pandemic, and more specifically the severe acute respiratory disease causing both premature death and chronic lung conditions that it involves, has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering. The severity of the crisis demonstrates also the importance of Union action on the prevention and management of respiratory diseases.
Amendment 138 #
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 to support rights- and evidence-based approaches with significant impact in order to improve the prevention and control of the spread of severe human diseases across borders, to develop and make available products for the prevention and treatment of diseases without discrimination, to combat other serious cross- border threats to health, to prevent and respond to medicines shortages, and to safeguard the health and well-being of all people in the Union. __________________ 8 Communication to the European 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 168 #
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 creating strategic stockpilingreserves of essential medical supplies or capacity building in crisis response, preventive measures related to vaccination, and immunisation and health promotion, strengthened surveillance programmes, platforms to share best practices from conventional and integrative medical approaches. 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 243 #
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16a) The Programme should provide for equal access to healthcare. “Health inequalities” cover situations ranging from unequal access to prevention, treatment, fragmented access across regions, differences in health status origin, and to the distribution of health determinants between different population groups. Health inequalities are avoidable by reasonable means, and thus preventable.
Amendment 248 #
Proposal for a regulation
Recital 17
Recital 17
(17) Non-communicable diseases are a result of a combination of genetic, physiological, environmental and behavioural risk factors. Such non- communicable diseases as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes, represent major causes of disability, ill-health, health- related retirement, and premature death in the Union, resulting in considerable 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. SDG Target 3.a, on strengthening the implementation of the WHO Framework Convention on Tobacco Control is crucial to achieving an effective, sustainable reduction in preventable non- communicable diseases.
Amendment 259 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) Prevention and health promotion are key in achieving sustainable health systems by ensuring that citizens live disease-free longer and by reducing the pressure of preventable diseases, especially of non-communicable diseases, on health systems. In order to enhance the health status and quality of life of Union citizens, primary care healthcare professionals, including community pharmacists, and community groups should be involved in raising public health awareness, participating in disease prevention and control. The Programme should support Union actions and support Member States in developing and implementing prevention and health promotion, early diagnosis and screening strategies. This includes healthy public policies, community action for health, supportive environments and reorienting disease prevention services as part of primary health care services towards health promotion. Screening programmes need to be evidence-based and avoid adverse effects and unnecessary burden on health services.
Amendment 266 #
Proposal for a regulation
Recital 17 b (new)
Recital 17 b (new)
(17b) Early detection and screening plays a crucial role in all treatment and prevention strategies. Prevention is key in achieving sustainable health systems by ensuring that citizens live disease-free longer and by reducing the pressure of preventable diseases, especially of non- communicable diseases, on health systems. In order to enhance the health status and quality of life of Union citizens, primary care healthcare professionals, including community pharmacists, should be involved in raising public health awareness, participating in disease prevention and control. The Programme should support Union actions and support Member States in developing and implementing prevention, early diagnosis and screening strategies. This includes disease prevention services as part of primary healthcare services and the implementation of population level policies to address social, environmental and behavioural risk factors.
Amendment 270 #
Proposal for a regulation
Recital 17 c (new)
Recital 17 c (new)
(17c) To achieve Universal Health Coverage as highlighted in the Political Declaration on UHC adopted by the United Nations in September 2019, the EU and its Member States will strive to achieve all targets of SDG 3. In addition to SDG 3.4, it will be essential to achieve SDG3.7 on sexual and reproductive health and rights, as this is a crucial component of UHC. This Programme should therefore contribute to the universal access to and full respect of sexual and reproductive health and rights at the Union and international level.
Amendment 279 #
Proposal for a regulation
Recital 18
Recital 18
(18) The Programme therefore should contribute to disease prevention throughout the lifetime of an individual and to health promotion by addressing health risk factors, such as the use of tobacco and related products and exposure to their emissions, the harmful use of alcohol, and the consumption of illicit drugs. The Programme should also contribute to the reduction of drugs-related health damage, unhealthy dietary habits and physical inactivity, and exposure to environmental pollution in light of the zero-pollution ambition for a toxic-free environment, and foster supportive environments for healthy lifestyles in order to complement Member States action in these areas. The Programme should also therefore contribute to the objectives of the European Green Deal, the Farm to Fork Strategy and the Biodiversity Strategy.
Amendment 286 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
Amendment 297 #
Proposal for a regulation
Recital 19
Recital 19
(19) Cancer is the secondrdiovascular disease is the leading cause of mortality in the Member States after cardiovascular diseases. It is also one of(36% of all deaths in the EU), followed by cancer as the second leading cause of mortality in the Member States (26% of all deaths in the EU). They are also amongst the 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 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 306 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) It is well recognised that cancer is often diagnosed late, which means that fewer treatment options are available for people affected by an advanced stage of the disease. If more patients were diagnosed earlier, it could lead to much more effective treatment outcomes, better quality of life, as well as improved overall survival rates. An earlier diagnosis means also a reduction in the healthcare burden. Compared to early diagnosis, cancer screening is a distinct and more complex public health strategy that mandates additional resources, infrastructure and coordination. When evidence-based, planned effectively, appropriately financed and implemented, screening can reduce deaths from cancer and, in the case of some cancer types, can also reduce the risk of developing cancer. The Programme should therefore contribute to the investment in early diagnosis and evidence-based screening, and to promotion and awareness raising in relation to the benefits and adverse effects of such early diagnosis and screening.
Amendment 317 #
Proposal for a regulation
Recital 19 b (new)
Recital 19 b (new)
(19b) The health workforce has a vital role in building resilient health systems and in reaching the highest attainable standard of health. The Programme should therefore underpin the Commission’s work on effective, accessible and resilient healthcare and health systems, and support the development and implementation of a strategy on the health workforce. In synergy with ESF+ and in particular EaSI, the Programme should provide under the Strategy the means for harmonized training and education for the purpose of improving the curricula of health professionals, in particular with regard to health promotion and disease prevention as well as digital skills, in order to obtain a patient-oriented and outcome-based health approach. The Programme should also support, via the Strategy, Member States to address the brain drain and migration of the healthcare workforce from less-developed countries and implement retention policies. Being able to deliver high quality, personalised, targeted and integrated care, and improve health service coverage depends on the availability, accessibility, acceptability, adaptability and quality of the health workforce.
Amendment 338 #
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, holistic and effective medicines and treatment, promote incentives to develop such medicinal products as antimicrobialsboost the production capacity for antimicrobials, personalized treatment and vaccination, and foster the digitial transformation of healthcare products and platforms for monitoring and collecting information on medicines. The programme should also strengthen decision-making on medicines by enabling access to and analysis of real- world healthcare data by regulators and HTA bodies. The Programme should also help to ensure best use of research results and facilitate the uptake, scaling-up and deployment of health innovation in healthcare systems and clinical practice. In 2020, the Commission announced the ‘Pharmaceutical strategy for Europe’ with the overall goal of helping to ensure the Union’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry’s innovation efforts in the Union and globally. The Programme should support the implementation of the Pharmaceutical strategy for Europe and the reduction of the medication-related burden.
Amendment 356 #
Proposal for a regulation
Recital 22 a (new)
Recital 22 a (new)
(22a) Resolution WHA 67.18 of the World Health Assembly urges parties to 1) adapt, adopt and implement, where appropriate, the WHO Traditional Medicine Strategy 2014 – 2023, as a basis for national traditional and complementary medicine programmes or work plans; and to 2) develop and implement working plans to integrate traditional and complementary medicine into health services, particularly primary health care services. The WHO Traditional Medicine Strategy 2014 – 2023 aims to support Member States in developing policies and implementing action plans to promote health with the support of traditional, complementary and integrative medicine.
Amendment 359 #
Proposal for a regulation
Recital 22 b (new)
Recital 22 b (new)
(22b) To expand access to health technologies, the Programme should support actions that contribute to the implementation of the 2019 Resolution by the World Health Assembly on improving the transparency of markets for medicines, vaccines and other health products.
Amendment 366 #
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, and actions including the use of non-antibiotic integrative treatments, in the framework of an integrated and integrative policy on patient safety and prevention of medical errors.. __________________ 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 391 #
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 cancer.rdiovascular disease, cancer, chronic respiratory disease, diabetes and mental health conditions and other major chronic diseases, which require extensive knowledge sharing due to the complexity of cases and co-morbidities; __________________ 16 Directive 2011/24/EU of the European 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 422 #
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, accessibility, safety and affordability in the Union of medicines, medical devices and other crisis relevant products, to support innovation and to support integrated and coordinated work and implementation of best practices among Member States, and to address inequalities 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 438 #
Proposal for a regulation
Article 2 – paragraph 1 – point 10 a (new)
Article 2 – paragraph 1 – point 10 a (new)
(10a) 'independent from industry' means receiving less than 20% of core funding as well as of project funding, respectively, from industry;
Amendment 444 #
Proposal for a regulation
Article 3 – paragraph 1 – introductory part
Article 3 – paragraph 1 – introductory part
The Programme shall pursue the following general objectives, in keeping with the “One Health” approach where relevant:
Amendment 445 #
Proposal for a regulation
Article 3 – paragraph 1 – point -1 (new)
Article 3 – paragraph 1 – point -1 (new)
(-1) improve the health of people in the Union, including in particular by health promotion, disease prevention and by addressing health inequalities; (This should be the first of the general objectives.)
Amendment 464 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) improve the availability in the Union of medicines, medical devices and other crisis relevant producttreatments and medical devices, contribute to their accessibility and affordability, and support innovationtheir safe and effective use, and boost research and innovation in healthcare with a net benefit for public health;
Amendment 477 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) strengthen health systems, their sustainability and the healthcare workforce, including by digital transformation that fully respects the European data protection framework, harmonized education and training, 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.
Amendment 488 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
(3a) support actions on integrative, person-centred and outcome-based care and health systems;
Amendment 496 #
Proposal for a regulation
Article 4 – paragraph 1 – point -1 (new)
Article 4 – paragraph 1 – point -1 (new)
Amendment 497 #
Proposal for a regulation
Article 4 – paragraph 1 – point -1 a (new)
Article 4 – paragraph 1 – point -1 a (new)
Amendment 498 #
Proposal for a regulation
Article 4 – paragraph 1 – point -1 b (new)
Article 4 – paragraph 1 – point -1 b (new)
(-1b) support implementation of the zero pollution ambition for a toxic-free environment;
Amendment 501 #
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 the coordination of stress testing of national healthcare systems;
Amendment 521 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3
Article 4 – paragraph 1 – point 3
(3) support actions to ensure appropriate availability, accessibility and affordability of crisis relevant products and other necessary health supplies, including via collective safeguards in favour of the public such as transparency, accessibility and affordability clauses and non- exclusive licences for the exploitation of the final products;
Amendment 527 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3 a (new)
Article 4 – paragraph 1 – point 3 a (new)
(3a) provide incentives to increase production of essential APIs and medicines in Europe and to diversify the supply chain to guarantee supply and affordable access at all times;
Amendment 532 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4
Article 4 – paragraph 1 – point 4
(4) sStrengthen the effectiveness, accessibility, sustainability and resilience of health systems, including by supporting digital transformation, the uptake of digital tools and services, systemic reforms, implementation of new care models and the achievement of universal health coverage, and address inequalities in healthwhich includes access to sexual and reproductive health and rights, and address inequalities in health, including gender and intersectional inequalities;
Amendment 538 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4 a (new)
Article 4 – paragraph 1 – point 4 a (new)
Amendment 544 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4 b (new)
Article 4 – paragraph 1 – point 4 b (new)
(4b) 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 552 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5
Article 4 – paragraph 1 – point 5
(5) support actions aimed at strengthening health system’s ability to foster disease prevention and health promotion, patient rights and cross-border healthcare, and promote the excellence and cross-border recognition of medical and healthcare professionals;
Amendment 554 #
Proposal for a regulation
Article 4 – paragraph 1 – point 5 a (new)
Article 4 – paragraph 1 – point 5 a (new)
(5a) Support actions to ensure the collection of safe blood, and blood components that facilitate a wide range of essential, often live-saving treatments; support actions to raise awareness on the importance of non-remunerated blood donation to this end,
Amendment 562 #
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 canotably of major chronic diseases such as cardiovascular disease, cancer, chronic respiratory disease, diabetes and mental health conditions proportionate to their prevalencer;
Amendment 579 #
Proposal for a regulation
Article 4 – paragraph 1 – point 7
Article 4 – paragraph 1 – point 7
(7) foster and support the prudent and efficient use of medicines, and in particular of antimicrobials, andincluding by the use of non-antimicrobial treatment, the development of pharmaceuticals that are intrinsically less harmful for the environment, more environmentally friendly production and environmentally sound disposal of medicines and medical devices;
Amendment 580 #
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, comprehensive and disaggregated data by gender and age and gender-specific data to underpin policy making and monitoring, support the delivery of care and respond to unmet medical needs, and promote the use of health impact assessments of relevant policies;
Amendment 597 #
Proposal for a regulation
Article 4 – paragraph 1 – point 9 a (new)
Article 4 – paragraph 1 – point 9 a (new)
(9a) support the development of specific European diseases prevention and 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, by excellence networks;
Amendment 603 #
Proposal for a regulation
Article 4 – paragraph 1 – point 10
Article 4 – paragraph 1 – point 10
(10) support the Union’s contribution to international and global health initiatives., including support to global initiatives in favour of sexual and reproductive health and rights;
Amendment 664 #
Proposal for a regulation
Annex I – point a – point ii a (new)
Annex I – point a – point ii a (new)
(iia) coordination of a collaborative and open approach in the field of research and innovation, driving research towards outcomes including needed medicines, vaccines, medical devices and equipment;
Amendment 678 #
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 independent patient organisations and other relevant independent civil society organisations;
Amendment 756 #
Proposal for a regulation
Annex I – point f – point i
Annex I – point f – point i
(i) AStress tests and follow-up actions to foster Union-wide and cross-sectoral health crisis prevention, preparedness, management and response capacity of actors at Union, national, regional and local level, including contingency planning and preparedness exercises and the upskilling of medical, healthcare and public health staff;
Amendment 780 #
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 on the link between animal health, wildlife trade, environmental factors, and human diseases, including during health crises, also through the development of ambitious EU coordinated actions to improve animal welfare.
Amendment 781 #
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 on the link between animal health, animal welfare, wildlife trade, pet trade, intensive farming, environmental factors, and human diseases, including during health crises.
Amendment 796 #
Proposal for a regulation
Annex I – point g – point i a (new)
Annex I – point g – point i a (new)
(ia) Support implementing policies, national programmes and guidelines to overcome inequalities in access to healthcare, including health equity assessments;
Amendment 810 #
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, including by developing adequate indicators, and collect data and report publicly on barriers experienced by patients;
Amendment 818 #
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 the European Disease Prevention and Management Guidelines in the area of both communicable and noncommunicable diseases, such as cancer, paediatric cancer, cardiovascular diseases, neurodegenerative diseases, respiratory diseases and diabetes;
Amendment 848 #
Proposal for a regulation
Annex I – point h – introductory part
Annex I – point h – introductory part
(h) Actions on cancermajor chronic diseases:
Amendment 851 #
Proposal for a regulation
Annex I – point h – point i
Annex I – point h – point i
(i) Support Member States and NGOs in the promotion and implementation of the recommendations of the European Code against Cancer, as well as WHO recommendations on the prevention and control of chronic diseases;
Amendment 860 #
Proposal for a regulation
Annex I – point h – point ii
Annex I – point h – point ii
(ii) Support the establishment of quality assurance schemes for cancer centres and other disease-specific centres;
Amendment 862 #
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 of chronic diseases;
Amendment 866 #
Proposal for a regulation
Annex I – point h – point iv
Annex I – point h – point iv
(iv) Actions to support secondary prevention of cancerhronic diseases, such as early detection and diagnosis through screening;
Amendment 875 #
Proposal for a regulation
Annex I – point h – point v
Annex I – point h – point v
(v) Actions supporting access to cancerhronic disease services and to innovative medicines for cancerall major chronic diseases;
Amendment 895 #
Proposal for a regulation
Annex I – point h – point viii
Annex I – point h – point viii
(viii) Actions supporting the quality of life of cancer survivorhronic disease patients and care givers;
Amendment 898 #
Proposal for a regulation
Annex I – point h – point vii
Annex I – point h – point vii
(vii) Actions supporting quality in cancerhronic disease prevention and care including diagnosis and treatment;
Amendment 902 #
Proposal for a regulation
Annex I – point h – point ix
Annex I – point h – point ix
(ix) Support to the implementation, monitoring and enforcement of the Union’s tobacco control policy and legislation, and other related legislation in the area of prevention in line with the obligations in the WHO Framework Convention on Tobacco Control;
Amendment 904 #
Proposal for a regulation
Annex I – point h – point ix a (new)
Annex I – point h – point ix a (new)
(ixa) Actions to support a coordinated and integrative, multi-disciplinary and patient-centred approach regarding chronic disease patients, in particular in the area of paediatric cancer;
Amendment 907 #
Proposal for a regulation
Annex I – point h – point x
Annex I – point h – point x
(x) Establishment and support of a mechanisms for cross-specialty capacity building and continuous education in the area of cancerhronic disease care.
Amendment 917 #
Proposal for a regulation
Annex I – point h – point x a (new)
Annex I – point h – point x a (new)
(xa) Establishment and support of a competence network on integrative treatment;
Amendment 930 #
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 anonymised data on the quality, safety and efficacy of vaccines in use, without prejudice to the generation of robust evidence in the pre-approval phase;
Amendment 937 #
Proposal for a regulation
Annex I – point i – point iii
Annex I – point i – point iii
(iii) Support clinical trials to speed up the development, authorisation and equitable access to innovative, affordable safe and effective medicines and vaccines, including timely public access to clinical study reports;
Amendment 940 #
Proposal for a regulation
Annex I – point i – point iii a (new)
Annex I – point i – point iii a (new)
(iiia) support action for traceability rules on medicines both with regard to the final product and its components;
Amendment 942 #
Proposal for a regulation
Annex I – point i – point iv a (new)
Annex I – point i – point iv a (new)
(iva) Support action to modify the regulatory framework in the Union, to foster public health driven research and innovation and to encourage the discovery and development, production and fair distribution of innovative quality and affordable medicines, treatments, devices and vaccines for unmet medical needs in a transparent manner;
Amendment 946 #
Proposal for a regulation
Annex I – point i – point iv b (new)
Annex I – point i – point iv b (new)
(ivb) Support the assessment of the impact of intellectual property incentives on biomedical innovation in general and to explore credible and effective alternatives to exclusive protections for the financing of medical R&D, such as the numerous tools based on delinkage mechanisms;
Amendment 947 #
Proposal for a regulation
Annex I – point i – point iv c (new)
Annex I – point i – point iv c (new)
(ivc) Support action for implementing an EU wide list of approved medicines, indicating which products are interchangeable and key information on their composition, description, prescription requirements and administration;
Amendment 948 #
Proposal for a regulation
Annex I – point i – point iv d (new)
Annex I – point i – point iv d (new)
(ivd) Support action to enable information-sharing among Member States on medicines prices, including discounts and rebates, and on their pricing and reimbursement policies;
Amendment 966 #
Proposal for a regulation
Annex I – point i – point vii a (new)
Annex I – point i – point vii a (new)
(viia) Support actions for a sustainability assessment of applications of synthetic biology;
Amendment 975 #
Proposal for a regulation
Annex I – point i – point ix
Annex I – point i – point ix
(ix) Action to significantly reduce overall use of antimicrobials, to promote the prudent use and disposal of antimicrobials, and the use of non- antibiotic treatments;
Amendment 1061 #
Proposal for a regulation
Annex II – part B – point 3
Annex II – part B – point 3
3. Number of vaccine doses distributed [by type and MS]
Amendment 1063 #
Proposal for a regulation
Annex II – part B – point 5 a (new)
Annex II – part B – point 5 a (new)
5a. Number of cancer cases [by organ and MS]
Amendment 1064 #
Proposal for a regulation
Annex II – part B – point 6
Annex II – part B – point 6
6. Age-standardised five-year net survival of cervical, breast, lung, blood, brain and colorectal cancer as well as of heart attacks and stroke
Amendment 1068 #
Proposal for a regulation
Annex II – part B – point 7
Annex II – part B – point 7
7. Ratio of Cancer Registries (CRs) and number of Member States (MSs) reporting information on cervical, breast, lung, blood, brain and colorectal cancer stage at diagnosis
Amendment 1076 #
Proposal for a regulation
Annex II – part B – point 8 a (new)
Annex II – part B – point 8 a (new)
8a. Prevalence of overweight and obesity
Amendment 1081 #
Proposal for a regulation
Annex II – part B – point 8 b (new)
Annex II – part B – point 8 b (new)
8b. Prevalence of major chronic diseases as defined by WHO
Amendment 1084 #
Proposal for a regulation
Annex II – part B – point 12 a (new)
Annex II – part B – point 12 a (new)
12 a. Quantity of antimicrobial use [by type and MS, separately for humans and animals]
Amendment 1087 #
Proposal for a regulation
Annex II – part B – point 14 a (new)
Annex II – part B – point 14 a (new)
14a. Relative compliance with WHO air quality limits and environmental quality standards under EU water legislation