31 Amendments of Aldo PATRICIELLO related to 2020/0102(COD)
Amendment 490 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3 a (new)
Article 3 – paragraph 1 – point 3 a (new)
(3a) make health systems become resilient and better respond to health crises;
Amendment 576 #
Proposal for a regulation
Article 4 – paragraph 1 – point 6 a (new)
Article 4 – paragraph 1 – point 6 a (new)
(6a) support action for the elimination of vaccine preventable cancers, such as HPV and Hepatitis B;
Amendment 577 #
Proposal for a regulation
Article 4 – paragraph 1 – point 6 b (new)
Article 4 – paragraph 1 – point 6 b (new)
(6b) support actions to raise awareness on migraine as a chronic neurological disorder and its health, societal and economic impact, to develop ad-hoc strategies to ensure integration of migraine patients at work and more broadly in society, as well as to ensure timely and quality diagnosis and access to available treatments;
Amendment 612 #
Proposal for a regulation
Article 4 – paragraph 1 – point 10 a (new)
Article 4 – paragraph 1 – point 10 a (new)
(10a) support actions aimed at creating and developing a EU Platform for shortages, based on one harmonised data- collection model and national reporting systems of shortages interoperability, including the full implementation of an effective EU telematics infrastructure that will link data on medicine and supply chain data through interconnection of SPOR and FMD system;
Amendment 613 #
Proposal for a regulation
Article 4 – paragraph 1 – point 10 – point a (new)
Article 4 – paragraph 1 – point 10 – point a (new)
(a) support actions aimed at modernise and digitalise the EU regulatory Network at European and national level;
Amendment 662 #
Proposal for a regulation
Annex I – point a – point ii a (new)
Annex I – point a – point ii a (new)
(iia) Development of a single pan- European digital mechanism for better reporting, notifying and monitoring of potential shortages, by starting from supporting the implementation of a European common data repository and interconnection between regulatory information on medicines, contained in SPOR, with supply chain data, in FMD system, in all Member States;
Amendment 671 #
Proposal for a regulation
Annex I – point c – point i
Annex I – point c – point i
(i) Surveys, studies, centralized and accessible collection of data and statistics, methodologies, classifications, microsimulations, pilots, indicators, knowledge brokering and bench mark exercises;
Amendment 682 #
Proposal for a regulation
Annex I – point c – point iii
Annex I – point c – point iii
(iii) Expert groups and panels, including all relevant stakeholders, providing advice, evaluation, data and information to support the health policy development and implementation;
Amendment 686 #
Proposal for a regulation
Annex I – point c – point iii a (new)
Annex I – point c – point iii a (new)
(iiia) Setting up and management of a High Level Pharmaceuticals Forum at political level composed of authorities and relevant health care stakeholders to define priorities and concrete measures to be implemented at technical level;
Amendment 697 #
Proposal for a regulation
Annex I – point c – point iv
Annex I – point c – point iv
(iv) Studies and analysis, and scientific advice to support policymaking, and support to the scientific committees on "Consumer Safety" and, on "Health, Environmental and Emerging Risks". and on “Health care systems performance”
Amendment 705 #
Proposal for a regulation
Annex I – point d – introductory part
Annex I – point d – introductory part
(d) DEvaluation, development and implementation of Union health legislation and action, in particular through support to:
Amendment 707 #
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, including Pharmaco vigilance legislation, and relative actions; and technical support to the an harmonised implementation of legal requirementsand operational requirements across Member States Creation of a central repository for medicines in Europe and modernisation of Regulatory network;
Amendment 721 #
Proposal for a regulation
Annex I – point d – point iv
Annex I – point d – point iv
(iv) Development and, operation and maintenance of databases and digital tools and their interoperability, including where appropriate with other sensing technologies, such as space-basedalready established project such as creation of a central common repository for all medicines in Europe and SPOR implementation, including where appropriate with other;
Amendment 725 #
Proposal for a regulation
Annex I – point d – point v
Annex I – point d – point v
(v) Auditing and, assessment and inspection work in accordance with Union legislation;
Amendment 728 #
Proposal for a regulation
Annex I – point d – point ix
Annex I – point d – point ix
(ix) Collaboration with third countries on the areas covered by the Programme;
Amendment 749 #
Proposal for a regulation
Annex I – point e – point iv
Annex I – point e – point iv
(iv) Procurement, of goods and services, including MEAT criteria, necessary for the prevention and management of health crises and action to secure access to those essential goods and services;
Amendment 759 #
Proposal for a regulation
Annex I – point f – point iii
Annex I – point f – point iii
(iii) Support and/or procure emergency production of medical countermeasures, including essential medicines, chemicals and active substances, and the financing of cooperation on emergency health technology assessments and clinical trials; and secure financing of exceptional measures to free capacity of lines that can be utilised to provide ICU medicines;
Amendment 772 #
Proposal for a regulation
Annex I – point f – point v a (new)
Annex I – point f – point v a (new)
(va) Support actions to foster innovation on in repurposing, reformulation and combinations of off- patent medicines that that deliver relevant improvements for patients, healthcare professionals and/or healthcare systems;
Amendment 775 #
Proposal for a regulation
Annex I – point f – point v b (new)
Annex I – point f – point v b (new)
(vb) Actions to support harmonised implementation of electronic product information in all Members States, transition to telemedicine, at-home administration of medication and implementation of preventative and self- care plans, where possible and appropriate;
Amendment 787 #
Proposal for a regulation
Annex I – point f – point viii a (new)
Annex I – point f – point viii a (new)
(viiia) Actions to secure continuity of care and treatment and in particular of chronic conditions during health crisis;
Amendment 800 #
Proposal for a regulation
Annex I – point g – point ii
Annex I – point g – point ii
(ii) Training programmes for medical and healthcare staff, and programmes for temporary exchanges of staff;
Amendment 816 #
Proposal for a regulation
Annex I – point g – point ix
Annex I – point g – point ix
(ix) Support the establishment and implementation of programmes and in particular digital programmes assisting Member States and their action to improve health promotion and disease prevention (for communicable and non- communicable diseases) in hospitals and communities;
Amendment 871 #
Proposal for a regulation
Annex I – point h – point iv a (new)
Annex I – point h – point iv a (new)
(iva) Actions to ensure broad implementation of effective screening and vaccination programs and strengthening of infrastructure to achieve elimination of infection-related cancers;
Amendment 877 #
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, cost-effective and supportive screening and treatments for cancer;
Amendment 884 #
Proposal for a regulation
Annex I – point h – point v a (new)
Annex I – point h – point v a (new)
(va) Actions supporting access to the standard of cancer screening, treatment and care;
Amendment 890 #
Proposal for a regulation
Annex I – point h – point v b (new)
Annex I – point h – point v b (new)
(vb) Actions supporting quality in cancer prevention and care including diagnosis and treatment;
Amendment 891 #
Proposal for a regulation
Annex I – point h – point v c (new)
Annex I – point h – point v c (new)
(vc) Actions to promote health and safety for healthcare workers involved in cancer treatment;
Amendment 892 #
Proposal for a regulation
Annex I – point h – point vi
Annex I – point h – point vi
(vi) Actions supporting the continuity of care (integrated care approaches for prevention, diagnosis, treatment and follow- up care);
Amendment 899 #
Proposal for a regulation
Annex I – point h – point vii
Annex I – point h – point vii
(vii) Actions supporting quality in cancer prevention and care including vaccination, diagnosis and treatment;
Amendment 925 #
Proposal for a regulation
Annex I – point i – introductory part
Annex I – point i – introductory part
(i) Actions on medicines, vaccines and medical devices: (i) Support to initiatives to improve vaccination coverage rates in the Member States; support initiatives to ensure that vaccine coverage is extended beyond early childhood and that all population groups can be included in a lifelong vaccination approach; (ia) Ensure high vaccination coverage rates to achieve herd immunity to protect vulnerable members of the society who cannot be vaccinated due to medical reasons; (iib) Support building and sustaining resilient immunisation system to maintain high vaccine uptake; (iic) Make access to vaccination convenient – integrating vaccination into non-health care settings such as workplace and schools to encourage vaccination through all stages in life; Support a clear framework for expanding vaccine delivery and information to all relevant health care professionals, incl. nurses and pharmacists; (iid) Establish Electronic Immunisation Records, as set out in the Council;
Amendment 926 #
Proposal for a regulation
Annex I – point i – point ii
Annex I – point i – point ii
(ii) Support actions to fight vaccine hesitancy; (ii a) Support tools and platforms to collect real-world evidence on the safety, effectiveness and impact of vaccines after use to fight vaccine hesitancy (iib) Develop appropriate metrics to track programme progress, including changes in the legislative environment and attitudes toward vaccination requirements. (iic) Strengthen healthcare training and provide a continuous medical training for all health workers. Healthcare workers play an essential role in rebuilding population’s confidence in vaccination. (iid) Support Member States in developing social media and awareness programmes to promote the public health impact of vaccination and present a clear and balanced explanations of any potential risks and benefits to individuals;