9 Amendments of Christofer FJELLNER related to 2017/2254(INI)
Amendment 54 #
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas ECDC and EFSA have reconfirmed that antimicrobial resistance is one of the largest threats to public health;4a _________________ 4a http://onlinelibrary.wiley.com/doi/10.2903 /j.efsa.2018.5182/epdf
Amendment 144 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Stresses that the geographical differentiation of antimicrobial resistance levels differ significantly within the EU; Takes note that the consumption of antibacterial for systemic use in DDD per 1000 habitants and per day differentiate from 36.3 in Greece to 10.4 in the Netherlands; Regrets that some Member States have yet to inform on their national consumption, such as the Czech Republic, and Liechtenstein; Emphasizes the seriousness of this issue and the need for a legal framework at Union level to further harmonise efforts in combatting AMR;
Amendment 237 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Commission and the Member States to restrict or stop the sale of antibiotics by those doctors or veterinarians who prescribe them; Whereas certain advanced and broad spectrum antibiotics should only be allowed for usage within in patient care;
Amendment 293 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls for a review of the environmental risk assessments as part of the marketing authorisation process for antimicrobials;
Amendment 320 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Urges the European Commission to consider a new legislative framework to stimulate the development of new antimicrobials for humans, as already requested by the European Parliament on 10 March 2016 on the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products and in the parliamentary resolution (2015) 0197 of19 May 2015; notes that the Commission “One Health” Action Plan against AMR also commits itself to “analyse EU regulatory tools and incentives - in particular orphan and paediatric legislation – to use them for novel antimicrobials".
Amendment 335 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Encourages the European Medicines Agency (EMA) to review all, where appropriate, available information on the benefits and riskssafety risk or in the absence of evidence of a changed benefit-risk ratio of older antimicrobial agents and to consider whether any changes to their approved uses are required;
Amendment 360 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission and theto support Member States to supportin the implementation of new economic models, pilot projects and incentives to boost the development of new diagnostics, antibiotics, alternatives and vaccines;
Amendment 375 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Notes the hesitant approach of the industry to develop ‘last-line’ antibiotics against bacteria that are resistant to all other antibiotics owing to expected low profitability; calls for incentives for this research and definition of the regulatory pathwayat the business models for developing medicines are not suitable for antibiotic development as resistance can develop over time and as they are meant to be used as a measure of last resort, calls for incentives for this research and definition of the regulatory pathway as well as through reimbursement and HTA reforms to ensure that antimicrobials are more appropriately valued to sustain and promote innovation;
Amendment 388 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission and Member States to develop new incentive models that delink paymentin cooperation with researchers and industry to develop new incentive models for the development of antibiotics, including a delink between revenue from prescribing volume;