17 Amendments of Françoise GROSSETÊTE related to 2017/2254(INI)
Amendment 13 #
Draft opinion
Recital A a (new)
Recital A a (new)
Aa. whereas in the past 40 years only one novel class of antibiotics has been developed, despite the spreading and progress of new resistant bacteria, moreover there is clear evidence of resistance to new agents within existing classes of antibiotics;
Amendment 51 #
Draft opinion
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls for the use of transferable market exclusivities as an option of meaningful incentives, which would allow the licensee of a new antimicrobial compound to extend to exclusivity of another compound, provided that they are applied with due consideration to the sustainability of healthcare systems;
Amendment 60 #
Draft opinion
Paragraph 3
Paragraph 3
3. Expresses the urgent need to foster partnerships throughout the EU in order to enhance the exchange of best practices and improve knowledge on AMR; encourages further pursuing private-public collaborations, such as the Innovative Medicine Initiative (IMI) programmes "New Drugs for Bad Bugs", COMBACTE, TRANSLOCATION, Drive AB or ENABLE, to harness the power of collaboration; furthermore encourages public-private partnerships aiming to foster innovation in the field;
Amendment 112 #
Motion for a resolution
Paragraph 2 – subparagraph 1 (new)
Paragraph 2 – subparagraph 1 (new)
Insists that the use of antibiotics for preventive purposes in veterinary medicine should be strictly regulated, in accordance with the provisions of the new Regulation 2014/0257 (COD) on veterinary medicine;
Amendment 136 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Calls on the Commission and the Member States to align surveillance, monitoring and reporting of AMR patterns and pathogens; calls on the Commission to encourage the Member States to introduce and carry out monitoring of the national surveillance and AMR targets, and to support them in those tasks;
Amendment 186 #
Calls on the European Commission to set up a specific EU Priority Pathogen List taking account the WHO list, which could be the basis for supporting the status of priority antibiotics and would provide a real added-value by directing R&D investments to the greatest threats;
Amendment 215 #
Motion for a resolution
Paragraph 10
Paragraph 10
10. Is aware that the cost of rapid diagnostic tools (RDT) may exceed the price of antibiotics; calls on the Commission and the Member States to propose incentives for the industry to develop effective and efficient testing methods and to develop the use of rapid diagnostic tools; calls on health insurance carriers to cover the extra cost arising from the use of RDT, given the long-term benefits of preventing the unnecessary use of antimicrobials;
Amendment 218 #
Motion for a resolution
Paragraph 10 – subparagraph 1 (new)
Paragraph 10 – subparagraph 1 (new)
Notes that the recently adopted EU indicators helping Member States to monitor their progress in combating AMR only focus on antibiotic consumption but do not reflect appropriateness of use; calls on the ECDC to amend the EU indicators accordingly;
Amendment 224 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Commission and the Member States to restrimake sure doct or stop the sale of antibiotics by those doctors or veterinarians who prescribe thems and veterinarians receive no incentives - financial or otherwise - to prescribe or sell antibiotics;
Amendment 287 #
Motion for a resolution
Paragraph 14
Paragraph 14
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 338 #
Motion for a resolution
Paragraph 17 – subparagraph 1 (new)
Paragraph 17 – subparagraph 1 (new)
Stresses that early dialogue between innovators and regulatory authorities should be encouraged in order to adapt the regulatory framework when necessary to prioritize and speed up the development of antimicrobial medicines and to allow faster access.
Amendment 366 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission and the Member States to support the implementation of new economic models, pilot projects and various push and pull incentives to boost the development of new diagnostics, antibiotics, alternatives and vaccines;
Amendment 379 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Notes the hesitant approach ofvarious challenges faced by the industry to develop ‘last-line’ antibiotics against bacteria that are resistant to all other antibiotics owing to expected low profitabilitya lack of business-case; calls for incentives for this research and definition of the regulatory pathway;
Amendment 384 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission and Member States to develop new incentive models that delink payment from prescribing volume and are sustainable over the long-term, stimulate investment across the entire product development and life-cycle, target key public health priorities, and support appropriate medicinal use;
Amendment 394 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Calls for the use of transferable market exclusivities or market entry rewards to be considered as options for sustainable incentives;
Amendment 430 #
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Commission to advocate EU standards and measures for tackling AMR in trade agreements and to guarantee that our standards are being applied to meat imports from third countries;