26 Amendments of Adam JARUBAS related to 2020/0102(COD)
Amendment 144 #
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 and all relevant stakeholders, public, private and civil society, in a structured, regular, manner in order to 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 173 #
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 strategic, EU financed and coordinated, stockpiling of essential medical supplies or capacity building in crisis response, preventive measures related to 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 229 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) Effective use of Information Technology systems, including AI, in full respect of EU data protection and privacy legal framework, is key to improve regulatory efficiency across Europe; it is also necessary to optimize the European regulatory framework by harmonising regulatory telematics projects with a focus on data quality, interoperability and interdependency of the European regulatory framework, and to ensure a fit for purpose regulatory environment that is a key element to protect public health, provide access to high quality medicines and contribute to the prevention of shortages.
Amendment 348 #
Proposal for a regulation
Recital 22
Recital 22
(22) The Programme should therefore support actions to monitdevelop a single pan- European monitoring, reporting and notification system for shortages of medicines, medical devices and other healthcare products to avoid fragmentation of the single market 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 and effective medicines, promote incentives to develop such medicinal products as antimicrobials and foster the digitial transformation of healthcare products and platforms for unified pan- European monitoring and collecting information on medicines.
Amendment 507 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 a (new)
Article 4 – paragraph 1 – point 1 a (new)
(1a) create and develop 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 512 #
Proposal for a regulation
Article 4 – paragraph 1 – point 1 b (new)
Article 4 – paragraph 1 – point 1 b (new)
(1b) modernise and digitalise the EU regulatory Network at European and national level;
Amendment 663 #
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 672 #
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 benchmark exercises;
Amendment 684 #
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 health policy development and implementation;
Amendment 688 #
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 healthcare stakeholders to define priorities and concrete measures to be implemented at technical level;
Amendment 696 #
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 "Healthcare systems performance"
Amendment 703 #
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 718 #
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 already established project such as creation of a central common repository for all medicines in Europe and SPOR implementation, including where appropriate with other sensing technologies, such as space-based;
Amendment 723 #
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 734 #
Proposal for a regulation
Annex I – point d – point xi a (new)
Annex I – point d – point xi a (new)
(xia) effective public communication, awareness campaigns and stakeholder-led projects, including prevention and fight to disinformation;
Amendment 751 #
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 788 #
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, in particular of chronic conditions during health crisis;
Amendment 814 #
Proposal for a regulation
Annex I – point g – point ix
Annex I – point g – point ix
(ix) Support the establishment and implementation of programmesnational and pan- European programmes, in particular utilising digital solutions, assisting Member States and their action to improve health promotion and disease prevention (for communicable and non-communicable diseases) in hospitals and communities;
Amendment 829 #
Proposal for a regulation
Annex I – point g – point xi a (new)
Annex I – point g – point xi a (new)
(xia) Support the development and implementation of programmes assisting Member States to improve their generic and biosimilar use to increase healthcare system efficiency;
Amendment 883 #
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 effective European standard of cancer treatment and care across all Member States;
Amendment 914 #
Proposal for a regulation
Annex I – point h – point x a (new)
Annex I – point h – point x a (new)
(xa) Promote use of MEAT criteria in procurement mechanisms to enhance safe and timely usage of generic and biosimilar medicines in cancer care;
Amendment 922 #
Proposal for a regulation
Annex I – point h – point x b (new)
Annex I – point h – point x b (new)
(xb) actions to promote health and safety for healthcare workers involved in cancer treatment;
Amendment 955 #
Proposal for a regulation
Annex I – point i – point v a (new)
Annex I – point i – point v a (new)
(va) Support actions to foster innovation in repurposing, reformulation and combinations of off-patent medicines that that deliver relevant improvements for patients, healthcare professionals and/or healthcare systems;
Amendment 961 #
Proposal for a regulation
Annex I – point i – point vi
Annex I – point i – point vi
(vi) Support action to monitor, report and notify shortages of medicines and medical devices occurring in hospitals and community pharmacies, to collect reported shortages in a centralized database, interoperable with databases that contained regulatory data on medicines, to address such shortages, and to increase security of supplies;
Amendment 964 #
Proposal for a regulation
Annex I – point i – point vii
Annex I – point i – point vii
(vii) Support actions to encourage the development of innovative medicines and medical devices less harmful for the environment and promote greener manufacturing and reward investments in procurement processes;
Amendment 1062 #
Proposal for a regulation
Annex II – part B – point 3 a (new)
Annex II – part B – point 3 a (new)
3a. Ratio of use of generic and biosimilar medicines