50 Amendments of Sándor RÓNAI related to 2020/0102(COD)
Amendment 433 #
Proposal for a regulation
Article 2 – paragraph 1 – point 9
Article 2 – paragraph 1 – point 9
(9) ‘serious cross-border threat to health’ means a life- threatening or otherwise serious hazard to health of biological, chemical, radiological, nuclear, environmental or unknown origin which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection;
Amendment 453 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) protect people in the Union from serious cross-border threats to health; implement better preparedness and coordination within and between Member States as regards health emergencies;
Amendment 476 #
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 and green transformation, 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 and health literacy of the population.
Amendment 502 #
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 health risk assessment;
Amendment 528 #
Proposal for a regulation
Article 4 – paragraph 1 – point 3 a (new)
Article 4 – paragraph 1 – point 3 a (new)
(3a) support the research and development of new medicines, medical devices and health products, enhance clinical trials and research based on real world data;
Amendment 530 #
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 green and digital transformation, the uptake of digital tools and services, systemic reforms, implementation of new care models leading to person-centred systems and universal health coverage, and address inequalities in healthand inequities in health and promote a set of minimal health services standards and ensure that the right to affordable preventive and curative health and care as set out in the European Pillar of Social Rights is respected;
Amendment 536 #
Proposal for a regulation
Article 4 – paragraph 1 – point 4 a (new)
Article 4 – paragraph 1 – point 4 a (new)
(4a) support the digitalization of health, increasing the skills of citizens and health workers and services, the interoperability of systems and availability of data, ensuring data comparability, to improve the knowledge and evidence on health, support the creation and implementation of a European Health Data Space while respecting citizens´ data protection rights and the Union data protection framework;
Amendment 574 #
Proposal for a regulation
Article 4 – paragraph 1 – point 6 a (new)
Article 4 – paragraph 1 – point 6 a (new)
(6a) strengthen the programmes to fight against communicable diseases and health threats, as AMR, HIV/AIDS, tuberculosis, hepatitis, influenza, sexually transmitted infections among others, promoting healthy lifestyles, premature detection, access to treatment and long- life care;
Amendment 590 #
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 aiming to increase the coverage of patients and the response to more diseases and health problems;
Amendment 652 #
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 659 #
Proposal for a regulation
Annex I – point a – point ii
Annex I – point a – point ii
(ii) Critical health infrastructure relevant in the context of health crises, tools, structures, processes, production and laboratory capacity, including tools for surveillance, modelling, forecast, prevention and management of outbreaks and relevant medical products.
Amendment 711 #
Proposal for a regulation
Annex I – point d – point i
Annex I – point d – point i
(i) Implementation, enforcement, monitoring of Union health legislation and action for the protection and promotion of health; and technical support to the implementation of legal requirements;
Amendment 753 #
Proposal for a regulation
Annex I – point e – point v
Annex I – point e – point v
(v) Establishment and operation of a Union health response mechanism coordinated by the ECDC and with the assistance of other health-related agencies (EMA, EFSA, ECHA, EEA) of a Union reserve of medical and healthcare staff and experts and of a mechanism to deploy such staff and experts as necessary to prevent or respond to a health crisis throughout the Union; establishment and operation of a Union Health Emergency team to provide expert advice and technical assistance on request by the Commission in the case of a potential health crisis or health threat;
Amendment 767 #
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, on patients suffering from chronic diseases and other vulnerable groups, such as people living with addiction, with HIV/AIDS, tuberculosis or in socially vulnerable situations;
Amendment 771 #
Proposal for a regulation
Annex I – point f – point v a (new)
Annex I – point f – point v a (new)
(v a) Actions to support e-health, the transition to telemedicine, the use of digital health tools, enabling patients to use e-health solutions and implement self- care plans, empowering citizens and patients to self-manage as regards their health;
Amendment 778 #
Proposal for a regulation
Annex I – point f – point vii a (new)
Annex I – point f – point vii a (new)
(viia) Establishment and operation of a mechanism responsible for procurement and development of countermeasures against biological threats, including bioterrorism, and chemical, nuclear and radiological threats;
Amendment 801 #
Proposal for a regulation
Annex I – point g – point iii
Annex I – point g – point iii
(iii) Support toactions to address the decision of qualified health workers to leave their Member State of origin to work elsewhere, improve the geographical distribution of healthcare workforce, and avoidance of ‘medical deserts’void ‘medical deserts’ and the phenomenon of ‘brain drain’, and promote and implement retention policies in the healthcare sector as well in the health investigation and development sector;
Amendment 805 #
Proposal for a regulation
Annex I – point g – point iv
Annex I – point g – point iv
(iv) Support the establishment and coordination and deployment of Union Reference Laboratories and Centres, and of Centres of excellence of excellence, improve the access of and the coverage to all citizens that need it , and support the establishment of Union disease-specific platforms for the exchange, comparison and benchmarking of best practices between Member States;
Amendment 806 #
Proposal for a regulation
Annex I – point g – point v
Annex I – point g – point v
(v) Audit of Member States preparedness and response arrangements (such as crisis management, antimicrobial resistance, vaccination), and implementation of health programmes that address health promotion and disease prevention and tackle communicable and non-communicable diseases;
Amendment 817 #
Proposal for a regulation
Annex I – point g – point ix
Annex I – point g – point ix
(ix) Support the establishment and implementation of programmes assisting Member States and their action to improve health promotion and disease prevention (for communicable and non-communicable diseases) and mitigate the main risk factors of chronic diseases;
Amendment 822 #
Proposal for a regulation
Annex I – point g – point x
Annex I – point g – point x
(x) Support Member States’ actions to put in place healthy and safe urban, work and school environments, to enable healthy life choices and promote the regular practice of physical activity and healthy diets taking into account the needs of vulnerable groups;
Amendment 833 #
Proposal for a regulation
Annex I – point g – point xiii a (new)
Annex I – point g – point xiii a (new)
(xiiia) Support actions to combat all types of discrimination concerning patients and to ensure that there is equal access for all to health;
Amendment 836 #
Proposal for a regulation
Annex I – point g – point xiii b (new)
Annex I – point g – point xiii b (new)
(xiiib) Support actions to adopt a common set of health determinants and methodologies, and support Member States to collect, analyse and report these data and improve the knowledge, and support Union actions to mitigate health inequalities and iniquities;
Amendment 839 #
Proposal for a regulation
Annex I – point g – point xiii d (new)
Annex I – point g – point xiii d (new)
(xiiid) Support Member States’ actions to boost health education and health literacy, creating well-informed societies, enhancing healthier lifestyles;
Amendment 840 #
Proposal for a regulation
Annex I – point g – point xiii e (new)
Annex I – point g – point xiii e (new)
(xiiie) Support the creation and promotion of a Union platform for reliable and updated health information, available in all official languages of the Union, with food, medicines, health, sports and data on other issues;
Amendment 841 #
Proposal for a regulation
Annex I – point g – point xiii f (new)
Annex I – point g – point xiii f (new)
(xiiif) Support the development and implementation of guidelines on health promotion and disease prevention in different stages of a person's lifetime and needs; creating quality standards to focus on, inter alia, child health, maternal health, aging health, mental health and reproductive and sexual health;
Amendment 843 #
Proposal for a regulation
Annex I – point g – point xiii h (new)
Annex I – point g – point xiii h (new)
(xiiih) Support collaboration between different sectors to improve health determinants and enhance the benefits in health outcomes;
Amendment 844 #
Proposal for a regulation
Annex I – point g – point xiii i (new)
Annex I – point g – point xiii i (new)
(xiiii) Support the establishment of quality assurance schemes for disease- specific centres;
Amendment 845 #
Proposal for a regulation
Annex I – point g – point xiii j (new)
Annex I – point g – point xiii j (new)
(xiiij) Actions supporting the quality of life of chronic disease patients, care givers and informal carers;
Amendment 846 #
Proposal for a regulation
Annex I – point g – point xiii k (new)
Annex I – point g – point xiii k (new)
(xiiik) Actions supporting continuity of care (integrated care approaches for prevention, diagnosis, treatment and follow-up care);
Amendment 885 #
Proposal for a regulation
Annex I – point h – point v a (new)
Annex I – point h – point v a (new)
(va) Support equal and timely access to truly innovative medicines and therapies;
Amendment 888 #
Proposal for a regulation
Annex I – point h – point v b (new)
Annex I – point h – point v b (new)
(vb) Support implementing policies, national programmes and guidelines regarding reducing inequalities in access to essential therapies and medicines, supportive and palliative care of paediatric cancers across Europe, including availability and affordability of such health care and services;
Amendment 929 #
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 data to produce real- world evidence, promote research and evidence on the safety, effectiveness and impact of vaccines, while guaranteeing robust evidence generation in the pre- approval phase;
Amendment 933 #
Proposal for a regulation
Annex I – point i – point iii
Annex I – point i – point iii
(iii) Support clinical trials, including those involving increased coordination at Union level and with EMA, to speed up the development, authorisation and access to innovative, safe and effective medicines and vaccines; support publication of all clinical reports (including CSRs) on the day marketing authorisation is granted for such medicines and vaccines;
Amendment 941 #
Proposal for a regulation
Annex I – point i – point iv
Annex I – point i – point iv
(iv) Support action to ensure greater availability and affordability in the Union of medicines, vaccines, and medical devices and contribute to their affordability for patients and health systems, using the Union mechanism as joint procurement at the same time enhance the transparency of the process;
Amendment 951 #
Proposal for a regulation
Annex I – point i – point v a (new)
Annex I – point i – point v a (new)
(va) Support actions to implement models of R&D and IP ownership and management which prioritise the public interest and ensure that there are societal benefits, for example by including binding safeguards to ensure availability, accessibility and affordability of medical products developed with public funds;
Amendment 970 #
Proposal for a regulation
Annex I – point i – point viii
Annex I – point i – point viii
(viii) Action to strengthen the environmental risk assessment of pharmaceuticals and medical devices;
Amendment 974 #
Proposal for a regulation
Annex I – point i – point ix
Annex I – point i – point ix
(ix) Action to promote the prudent use and disposal of antimicrobials, surveillance of antimicrobial use, antimicrobial resistance and support action to fight against AMR;
Amendment 979 #
Proposal for a regulation
Annex I – point i – point x
Annex I – point i – point x
(x) Support action to foster international regulatory convergence on medicines and, vaccines, medical devices. and products and e-health solutions;
Amendment 983 #
Proposal for a regulation
Annex I – point i – point x b (new)
Annex I – point i – point x b (new)
(xb) action to promote data transparency in the entire value chain of medicines;
Amendment 985 #
Proposal for a regulation
Annex I – point i – point x d (new)
Annex I – point i – point x d (new)
(xd) Support actions aimed at strengthening the fight against counterfeiting and piracy of medicines and medical devices;
Amendment 986 #
Proposal for a regulation
Annex I – point i – point x e (new)
Annex I – point i – point x e (new)
(xe) Support actions to promote the reinforcement of investment in a joint R&D policy;
Amendment 987 #
Proposal for a regulation
Annex I – point i – point x f (new)
Annex I – point i – point x f (new)
(xf) Support the strengthening of investment in instruments for monitoring the commerce and availability of medicines for human use and medical devices, at national and Union level;
Amendment 988 #
Proposal for a regulation
Annex I – point i – point x g (new)
Annex I – point i – point x g (new)
(xg) Support research into possible repurposing of existing drugs, exploring new uses and indications of therapies for existing drugs;
Amendment 989 #
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 997 #
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 benchmarking and capacity building for the uptake of innovative tools and technologies; digital upskilling of health care professsionals and citizens;
Amendment 1003 #
Proposal for a regulation
Annex I – point j – point iii b (new)
Annex I – point j – point iii b (new)
(iiib) Support the development of digital tools and digital solutions to increase the use of e-health and improve the sustainability and resilience of healthcare systems;
Amendment 1004 #
Proposal for a regulation
Annex I – point j – point iii c (new)
Annex I – point j – point iii c (new)
(iiic) Support action to scale up cross- border information exchange services and commence the implementation of projects such as Patient Summary and ePrescription;
Amendment 1009 #
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;
Amendment 1012 #
Proposal for a regulation
Annex I – point k – point iii
Annex I – point k – point iii
(iii) Communication to promote disease prevention andand protect health, prevent disease and promote healthy lifestyles, in cooperation with all concerned actors at international, Union and nat, national and regional level.;