35 Amendments of Mick WALLACE related to 2020/0102(COD)
Amendment 172 #
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 crisisall aspects of a health crisis in a holistic manner, the Programme should provide support to the actions taken in the framework of the mechanisms and structures established under Decision No 1082/2013/EU of the European Parliament and of the Council10 and other relevant mechanisms and structures established at Union level. This could include strategic stockpiling of essential medical supplies or capacity building in crisis response, preventive measures related to health education and information, 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 179 #
Proposal for a regulation
Recital 10 a (new)
Recital 10 a (new)
(10a) Given the impact that the COVID- 19 crisis had on access to healthcare services, which may not be directly related to the treatment of COVID-19 infections but remain essential healthcare services, including sexual and reproductive healthcare services, the Programme should respond to health crises in a holistic manner and support actions that aim to guarantee access to all essential healthcare services.
Amendment 187 #
Proposal for a regulation
Recital 12
Recital 12
(12) With a view to protect people in vulnerable situations, including those suffering from mental illnesses and chronic diseases, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable grouppeople with a disadvantaged socio economic status, women, victims/survivors of sexual and gender-based violence, LGBTI people, ethnic minorities, Roma people, migrant people, people living with disabilities, suffering from mental illnesses and chronic diseases, and other marginalised, discriminated against, vulnerable, underserved groups, the Programme should also promote actions which address the collateral impacts of the health crisis on people belonging to such vulnerable groups. The Programme should therefore support actions which aim to address all social determinants of health including gender with an intersectional approach, with a view of putting an end to all health inequalities including gender- based inequalities, responding to people’s specific health needs including women’s health needs, and aim to ensure continued access to all health care services.
Amendment 194 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) Article 8 TFEU gives the Union the task of eliminating inequalities and promoting equality between men and women in all of its activities. The principle of gender mainstreaming should be applied to all activities implemented through this Programme, and this Programme should contribute to achieving the common objectives set out in the Council conclusions on women's health of 22 June 2006. This Programme should support actions which promote gender mainstreaming in healthcare, address women’s specific health needs as some health issues affect women exclusively or disproportionately, including sexual and gender-based violence as well as certain aspects of sexual and reproductive health, address gender aspects of health including sexual and reproductive health and rights as committed to in the Gender Equality Strategy, aim to reduce gender inequalities in health recognizing gender as a key determinant of health, collect disaggregated and gender-specific data on the status of women’s health to measure women’s unmet medical needs, and provide gender-sensitive health information, education and promotion, prevention measures and treatment.
Amendment 220 #
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, taking an intersectional and gender-sensitive approach to address social determinants of health and differential vulnerabilities leading to inequitable health outcomes, and ensure an efficient public health workforce equipped with the right skills, including digital skills. The development of a European health data space 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 ensuringincluding through the achievement of Universal Health Coverage, as well as solidarity and equity, to ensure accessibility to all and equal access according to need, regardless of ethnicity, gender, age, social status or ability to pay, and to reduce health inequalities. The Programme should support actions that aim to ensure that patients’ rights are upheld, including on the privacy of their data, are duly respectedthe right to receive respectful and dignified care, free from all forms of discrimination, mistreatment or violence, the right to patient confidentiality including the privacy of their data, the right to receive accurate, unbiased information and education on all aspects of their health including sexual and reproductive health, and to give informed consent. __________________ 12Council Conclusions on Common values and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1).
Amendment 258 #
Proposal for a regulation
Recital 17 a (new)
Recital 17 a (new)
(17a) Chronic diseases develop slowly, are long-lasting and often incurable. Chronic disease patients often live with several comorbidities, which makes it complex to treat and manage them. The Union and the Member States can greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines, such as cardiovascular disease, neurodegenerative diseases, respiratory diseases and diabetes. Moreover, a significant proportion of chronic diseases are preventable by addressing major risk factors such as tobacco use, unhealthy diets, physical inactivity and air quality. Chronic diseases develop slowly, are long-lasting and often incurable. Chronic disease patients often live with several comorbidities, which makes it complex to treat and manage them. The Union and the Member States can greatly reduce the burden of Member States by working together to achieve a better and more effective management of diseases, and the Programme should support actions in this area. The Programme should support the development of specific European Diseases Management Guidelines, such as cardiovascular disease, neurodegenerative diseases, respiratory diseases and diabetes. Moreover, a significant proportion of chronic diseases are preventable by addressing major risk factors such as tobacco use, unhealthy diets, physical inactivity and air quality.
Amendment 285 #
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, 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 308 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) While the Union currently has a strong focus on cancer as expressed in ‘Europe’s Beating Cancer Plan’ and Horizon Europe’s Mission on Cancer, the Programme must 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. In Europe, chronic diseases are responsible for 77% of the total disease burden (measured in DALYs = disability-adjusted life years). Of these, cardiovascular disease makes up 23%, neuropsychiatric conditions 20% and cancer 11%. The Programme should ensure that the actions it supports will benefit equitably all chronic disease patients. In that context, it should be acknowledged that the Programme goes beyond the current EU mandate, running well into the next EU mandate as it comes to an end in 2027.
Amendment 319 #
Proposal for a regulation
Recital 19 b (new)
Recital 19 b (new)
(19b) Heart attacks and strokes often occur in people previously undiagnosed with cardiovascular disease. Many of these are due to undetected genetic conditions, such as familial hypercholesterolaemia, arrhythmias, congenital heart disease and cardiomyopathies and conditions, such as hypertension. The Programme should support the development of policies and interventions for reaching out to and managing individuals at high risk of developing cardiovascular disease to prevent the onset of the disease and reduce mortality.
Amendment 321 #
Proposal for a regulation
Recital 19 c (new)
Recital 19 c (new)
(19c) A crucial part of treatment for cardiovascular disease is rehabilitation after an event, including counselling, medical treatment, exercise and psychological support. These programmes help prevent recurrence, optimise quality of life, reintegrate patients into the job market and reduce the burden on health services by reducing hospital readmissions. Although the considerable benefits of cardiac and stroke rehabilitation for patients, as well as the wider society, are well-documented, access to and uptake of quality rehabilitation is patchy in most of the Union’s Member States and is considered an underutilised resource. The Programme should support increased uptake of rehabilitation and secondary prevention.
Amendment 390 #
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, chronic respiratory disease, diabetes and mental health conditions and other major chronic diseases, which require extensive knowledge sharing due to the complexity of cases and co-morbidities, and their increasing prevalence. __________________ 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 427 #
Proposal for a regulation
Article 2 – paragraph 1 – point 4
Article 2 – paragraph 1 – point 4
(4) ‘crisis relevant products’ means products and substances necessary, in the context of a health crisis, to prevent, diagnose or treat a disease and its consequences, as well as other medical products and substances that remain essential during a health crisis, included but not limited to: medicinal products - including vaccines - and their intermediates, active pharmaceutical ingredients and raw materials; medical devices; hospital and medical equipment (such as ventilators, protective clothing and equipment, diagnostic materials and tools); personal protective equipment; disinfectants and their intermediary products and raw materials necessary for their production);
Amendment 451 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) support health promotion and disease prevention, reduce health inequalities, improve physical and mental health, protect people in the Union from serious cross-border threats to health;
Amendment 463 #
Proposal for a regulation
Article 3 – paragraph 1 – point 2
Article 3 – paragraph 1 – point 2
(2) support existing and future Union health legislation, improve the availability in the Union of medicines, medical devices and other crisis relevant products, contribute to their accessibility and affordability, and support innovationsafe and effective use, and boost research and innovation in healthcare;
Amendment 469 #
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 products, including products which remain essential in times of crisis, contribute to their affordability, and support innovation;
Amendment 478 #
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 of all health care services and procedures, and by increased integrated and coordinated work among the Member States, sustained implementation of best practice and data sharing, to increase the general level of public health.
Amendment 533 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4
Article 4 – paragraph 1 – point 4
(4) strengthen the effectiveness, accessibility, sustainability and resilience of health systems, including by supporting digital transformation, the uptake of digital tools and services, systemic reforms, implementation of new care models and 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 548 #
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 promotioninformation, education and promotion with a gender perspective, patient rights and cross-border healthcare, and promote the excellence of medical and healthcare professionals;
Amendment 566 #
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 cancermajor chronic diseases such as cardiovascular disease, cancer, chronic respiratory disease, diabetes and mental health conditions;
Amendment 584 #
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, reliable, 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 604 #
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 653 #
Proposal for a regulation
Article 20 – paragraph 2
Article 20 – paragraph 2
2. The interim evaluation of the Programme shall be performed once there is sufficient information available about their implementation, but not later than four years after the start of the implementation and before any decision is taken on future work programmes. The results of the interim evaluation shall be made public.
Amendment 849 #
Proposal for a regulation
Annex I – point h – introductory part
Annex I – point h – introductory part
(h) Actions on cancermajor chronic diseases:
Amendment 850 #
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 858 #
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 863 #
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 867 #
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 874 #
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 897 #
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 900 #
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 survivors and of chronic disease patients and care givers;
Amendment 906 #
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 1065 #
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 and colorectal cancer, heart attacks and stroke
Amendment 1066 #
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, and colorectal cancer stage at diagnosis as well as other major chronic diseases
Amendment 1075 #
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 1089 #
Proposal for a regulation
Annex II – part B – point 14 a (new)
Annex II – part B – point 14 a (new)
14a. Prevalence of major chronic diseases as defined by WHO