24 Amendments of Fredrick FEDERLEY related to 2020/2071(INI)
Amendment 18 #
Motion for a resolution
Citation 24 a (new)
Citation 24 a (new)
- having regard to the Commission communication of 11 December 2019 on ‘The European Green Deal’,
Amendment 19 #
Motion for a resolution
Citation 24 b (new)
Citation 24 b (new)
- having regard to its resolution of 15 January 2020 on the European Green Deal,
Amendment 73 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas shortage of medicines destabilizes the organization of care and generates high human and financial costs;
Amendment 76 #
Motion for a resolution
Recital B b (new)
Recital B b (new)
Bb. whereas access to suitable and affordable diagnostic tests and vaccines is as vital as access to safe, effective and affordable medicines;
Amendment 211 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Recalls that shortage of medicines is a global challenge; stresses that developing countries, such as a number of African countries, are the most affected by these shortages; urges that access to medicines in developing countries be tackled in a wider context in the WHO framework ; calls on the Commission and the Member States to increase their support to developing countries, in particular through the rescUE strategic reserve;
Amendment 228 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Recalls the shortages of female hormonal drugs used for contraception and hormone replacement therapy (HRT); notes with concern the threats they pose to women and girls' sexual and reproductive health and rights; stresses the importance to enhance control and management of the manufacturing, stockpiling and marketing of those medicines to ensure continuity in supply chains, fair pricing and availability for women;
Amendment 261 #
Motion for a resolution
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Notes that the risks are particularly high amongst vulnerable populations such as children, the elderly, pregnant women, people affected by a disability, patients with chronic diseases or cancer or people in intensive care unit (ICU);
Amendment 278 #
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 medicinesmedicinal products of major therapeutic interest ; calls on the Commission to map out potential production sites in the EU and their production capacity; suggests that the Commission also draw up a map of the production sites established in third countries;
Amendment 325 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. calls on the Commission to present a specific strategy for managing shortages of medicines and medical products in Europe;
Amendment 455 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Stresses the importance of research and innovation, and calls for the establishment of a genuine European network, given that the price of relocation must not be a deterioration in the quality of medical research; highlights the role of European projects and SMEs in improving access to medicines in the Union; underlines the crucial role of the Horizon Europe program in this respect;
Amendment 471 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls for strengthening of the European Medicines Market to speed up patient access to medicines, make care more affordable, maximise savings in national health budgets and avoid administrative burdens for generic and biosimilar companies ;
Amendment 481 #
Motion for a resolution
Paragraph 11 d (new)
Paragraph 11 d (new)
11d. Stresses that the added value and economic impact of biosimilar medicines on the sustainability of healthcare systems should be analysed, their market entry should not be delayed, and, where necessary, measures to support their introduction to the market should be examined;
Amendment 514 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12a. Welcomes the recent creation green lanes, set up to facilitate the transport of all goods, in order to allow the smooth running of the transport not only of medicines but also of raw materials, intermediate products and related materials, including packaging;
Amendment 517 #
Motion for a resolution
Paragraph 12 b (new)
Paragraph 12 b (new)
12b. Calls for the establishment of European lists of 'medicinal products of major therapeutic interest' along the lines of the 'WHO model list of essential medicines'; suggests that the EMA shortage risk indicators (manufacturing and quality) be used to identify high risk products,
Amendment 519 #
Motion for a resolution
Paragraph 12 d (new)
Paragraph 12 d (new)
12d. Encourages the development of shortage prevention and management plans across all Member States; believes that these plans could result from an analysis of manufacturing and distribution risks and include measures on building up stocks, diversifying sources of supply for raw materials and creating other manufacturing sites to ensure resilience from production;
Amendment 520 #
Motion for a resolution
Paragraph 12 e (new)
Paragraph 12 e (new)
12e. Underlines that several Member States have already established alert systems which facilitate the anticipation and prevention of shortages; calls for the establishment of alert systems to anticipate shortage of medicines at national and European levels;
Amendment 579 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15a. Calls for the adoption of common definitions of 'supply disruption' and 'stock-out' of medicines as well as a grid of criteria for assessing the risk associated with each of these situations;
Amendment 581 #
Motion for a resolution
Paragraph 15 b (new)
Paragraph 15 b (new)
15b. Calls for the adoption of a common definition of 'medicinal products of major therapeutic interest' with reference to their usefulness in public health, the absence of an alternative and the fragility of the production chain;
Amendment 613 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Calls for further invitations to tender to be issuedjoint procurements at European level in an effort to counter shortages, as has been done following the onset of the COVID-19 virus, with simplified and transparent procedures in the interests of improved response times;
Amendment 688 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19a. Recalls that misinformation can lead to inappropriate use of medicines and the creation of unnecessary stockpiling;
Amendment 710 #
Motion for a resolution
Subheading 3 a (new)
Subheading 3 a (new)
Preventing and responding to shortages in the event of health crises
Amendment 722 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21a. Calls on the Commission to create a European strategic reserve of medicinal products of major interest, along the lines of the ‘RescEU’ mechanism, in order to alleviate shortages outside crisis periods; believes that the EMA could be the European regulatory authority responsible of this strategic reserve in order to prevent shortages of these medicines;
Amendment 730 #
Motion for a resolution
Paragraph 21 e (new)
Paragraph 21 e (new)
21e. Considers that in the event of a health crisis the closure of borders and customs controls cannot constitute an obstacle to cross-border movement of medicinal products of major interest within the Union; calls on the Commission and the Member States to set up secure and rapid procedures for checking products at the border during a health crisis in compliance with EU law;
Amendment 736 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22a. Welcomes, following the onset of the COVID-19 crisis, the introduction of more flexible rules in a bid to mitigate shortages and facilitate the circulation of medicines between Member States: acceptance of different packaging formats, reuse procedure to enable marketing authorisation holders to obtain approval in another Member State, longer expiry periods, use of veterinary medicinal products, etc.; calls on the Commission to monitor strictly the use of these arrangements and to keep them available in the event of problems or shortages;