10 Amendments of Bartosz ARŁUKOWICZ related to 2020/2071(INI)
Amendment 71 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas drug shortages may lead to possible delays in the treatment of patients, the need to switch to alternative treatments that may be less effective, and may have side effects and even put patients’ lives at risk;
Amendment 292 #
Motion for a resolution
Paragraph 4
Paragraph 4
4. Calls on the Commission and the Member States to take whatever action is needed to restore European health sovereignty and local pharmaceutical manufacturing, giving priority to essential and strategic medicines; calls on the Commission to map out potential and existing production sites in the EU;
Amendment 297 #
Motion for a resolution
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Calls on the Commission and the Member States to jointly identify, assess and eliminate the causes of drug shortages; calls for an ambitious EU plan to prevent drug shortages, expressed in short-, medium- and long-term strategies, which will aim to stimulate competition and investment in production, and will strengthen security of supply in order to guarantee sustainable and equal access to medicines;
Amendment 344 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Urges the Commission and the Member States to introduce tax and financial incentives in return for appropriate commitments and to authorise state aid to encourage producers to locate their operations in Europe, from compound manufacturing to packaging and distribution; emphasises the strategic significance of this sector and the importance of investing in European companies, in the interests of resource diversification; notes that all incentives should include explicit safeguards, such as information on the level of public contribution, and accessibility clauses to ensure equal access to medicines at a fair price;
Amendment 416 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Calls on the Commission and the Member States to create one or more European non-profit pharmaceutical undertakings which operate in the public interest to manufacture priority medicines of strategic importance for health care; sStresses the key contribution that can be made by new technologies and artificial intelligence in enabling European laboratory researchers to form networks and share their objectives and findings;
Amendment 503 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Recommends the introduction of centralised management, under the auspices of the European Medicines Agency (EMA), to bring about greater transparency in the distribution chain and the creation of a European supply management unit tasked with developing a European strategy to prevent and resolve breaks in supply;
Amendment 574 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Calls on the Commission and the Member States to adopt a joint definition of ‘medicines of strategic importance for health care’ and of ‘criticality’, emphasising the value of these medicines for public health, the lack of alternatives and the vulnerability of the production chain; calls for a European regulatory authority to be designated to carry out the task of setting quotas for the allocation of medicines from that reserve to the Member States, and which would have, in strictly defined situations, the ability to purchase medicines and distribute them to the Member States;
Amendment 594 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Calls on the Commission and Member States to develop innovative and coordinated strategies and to step up exchanges of good practice in the area of stock management; considers that the European Medicines Agency (EMA) could be designated as the regulatory authority tasked with preventing shortages of essential medicines, with a correspondingly wider remit and more staff; feels that better and closer cooperation is needed on medicine shortages between national agencies and the EMA;
Amendment 644 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to set up an innovative centralised digital platform for reporting, notifying and sharing information provided by national agencies and all stakeholders regarding shortages of medicines and medical equipment; stresses that this platform should be effective, easy to use, secure and transparent; welcomes the introduction by the EMA of the SPOC and i-SPOC systems; calls for existing information systems to be improved so as to provide a clear overview of difficulties, shortages and requirements in each Member State, with a view to preventing stockpiling; calls on the Commission and the Member States to establish a standardised early-warning system at national and EU level, strengthening the obligations of pharmaceutical companies to immediately report any interruption in the supply of medicines;
Amendment 677 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. CNotes that doctors must have access to up-to-date information on the availability of medicines in order to be able to respond appropriately to emerging and existing shortages; stresses that early awareness of the supply problem and the early identification of potential therapeutic alternatives may mitigate the possibility of adverse reactions that endanger patient safety; considers it essential to improve communication with healthcare professionals and patients on medicine availability through the use of innovative digital tools providing real-time data on the availability, location, quantity and price of a given medicine, in compliance with data protection legislation;