15 Amendments of Mairead McGUINNESS related to 2020/0102(COD)
Amendment 126 #
Proposal for a regulation
Recital 5
Recital 5
(5) On 11 March 2020 the World Health Organization (WHO) declared the novel coronavirus (COVID-19) outbreak a global pandemic. That pandemic has caused an unprecedented worldwide health crisis with severe socio-economic consequences and human suffering. Its impact has not been evenly felt: people more vulnerable in society, such as those with pre-existing chronic conditions or living in institutionalised care, have been at particular risk from the disease.
Amendment 146 #
Proposal for a regulation
Recital 6
Recital 6
(6) While Member States are responsible for their health policies, they are expected to protect public health in a spirit of European solidarity8 . Experience from the ongoing COVID-19 crisis has demonstrated that there is a need for a further firm action at Union level to support cooperation and coordination among the Member States in order to, not only in response to the current crisis, but in general. This cooperation should 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 204 #
Proposal for a regulation
Recital 13
Recital 13
(13) The COVID-19 crisis has highlighted many challenges in ensuring the supply of medicines, medical devices as well as personal protective equipment needed in the Union during the pandemics. The Programme therefore should provide support to actions which foster the production, procurement and, management, accessibility and affordability of crisis relevant products ensuring complementarity with other Union instruments.
Amendment 225 #
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, to progress deinstitutionalisation and move towards community-based care including for older people, and to deliver integrated services, from the community and primary health care to the highly specialised services, based on people's needs 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 ensuring that patients’ rights, including on the privacy of their data, are duly respected. __________________ 12Council Conclusions on Common values and principles in European Union Health Systems (OJ C 146, 22.6.2006, p. 1).
Amendment 254 #
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, chronic respiratory diseases, and diabetes and mental health conditions, 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 284 #
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, obesity, 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 354 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitor and prevent 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 countriesa single source. 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.
Amendment 393 #
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, cardiovascular disease, chronic respiratory disease, mental health conditions and other major chronic diseases. __________________ 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 456 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) support and foster public health and protect people in the Union from serious cross-border threats to health;
Amendment 468 #
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, contribute to their affordability, and supportccessibility and affordability not only during times of crisis, and support research and innovation;
Amendment 524 #
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 at times of non-crisis;
Amendment 534 #
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, progressing deinstitutionalisation and moving to community-based care including for older people, and universal health coverage, and address inequalities in health;
Amendment 572 #
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, including major chronic diseases and notably of cancer;
Amendment 1077 #
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 1090 #
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 the WHO