61 Amendments of Pavel POC related to 2017/2254(INI)
Amendment 3 #
Motion for a resolution
Citation 9 a (new)
Citation 9 a (new)
– having regard to the European Parliament resolution of 26 November 2015 on a new animal welfare strategy for 2016-2020,
Amendment 4 #
Motion for a resolution
Citation 11 a (new)
Citation 11 a (new)
– having regard to the general interest paper Volume 38, Issue 1 from January 2018: "The Role of the European Food Safety Authority (EFSA) in the Fight against Antimicrobial Resistance (AMR)";
Amendment 5 #
Motion for a resolution
Citation 11 b (new)
Citation 11 b (new)
Amendment 6 #
Motion for a resolution
Citation 13 a (new)
Citation 13 a (new)
– having regard to the proposal of a regulation of the European Parliament and of the Council on veterinary medicinal products (COM(2014)558 final)
Amendment 7 #
Motion for a resolution
Citation 14 a (new)
Citation 14 a (new)
– having regard to the January 2017, EFSA and EMA Joint Scientific Opinion on the measures to reduce the use of antimicrobials and the need to use antimicrobials in food producing animals ('RONAFA' opinion);
Amendment 9 #
Motion for a resolution
Citation 14 b (new)
Citation 14 b (new)
– having regard to the ECDC- EFSA-EMA publication which investigates the association between consumption of antimicrobials and occurrence of AMR in food-producing animals and in humans; first Joint report 2015 (JIACRA I) and second 2017 (JIACRA II);
Amendment 12 #
Motion for a resolution
Citation 16 a (new)
Citation 16 a (new)
– having regard to ECDC Report 2016 on Antimicrobial resistance surveillance in Europe;
Amendment 14 #
Motion for a resolution
Citation 16 b (new)
Citation 16 b (new)
– having regard to the EFSA and ECDC Scientific report from February 2018, entitled “The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2016”1a _________________ 1a http://www.efsa.europa.eu/en/press/news/ 180227
Amendment 26 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Amendment 31 #
Motion for a resolution
Recital A b (new)
Recital A b (new)
Ab. whereas prudent antibiotic use and infection prevention and control in all healthcare sectors are cornerstones for effectively preventing the development and transmission of antibiotic-resistant bacteria;
Amendment 39 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas vaccinations and rapid diagnostic tools (RDT) have the potential to limit antibiotic abuse; whereas RDT allow healthcare professionals to quickly diagnose a patient with a bacterial or viral infection and, consequently, to reduce the misuse of antibiotics and the risk of resistance developing1a; _________________ 1aWHO Global guidelines on the prevention of surgical site infection (2016), available at: http://www.who.int/gpsc/ssi-guidelines/en/
Amendment 45 #
Motion for a resolution
Recital C
Recital C
C. whereas healthcare-associated infections (HAI) are often dueoccur due to lacking prevention measures which lead to antibiotic-resistant bacteria; whereas the European Centre for Disease Prevention and Control (ECDC) estimates that approximately 4 million patients acquire a HAI each year in the EU and that approximately 37 000 deaths result directly from these infections;
Amendment 49 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas active screening programs with RDT have been proven to significantly contribute to the control of HAI and the reduction of the spread within hospitals and between patients1a _________________ 1aCelsus Academie voor Betaalbare zorg. Cost-effectiveness of policies to limit antimicrobial resistance in dutch healthcare organisations. Research report. January 2016. Available at: https://goo.gl/wAeN3L
Amendment 52 #
Motion for a resolution
Recital C b (new)
Recital C b (new)
Cb. whereas the use of medical devices can prevent Surgical Site Infections and therefore prevent and control the development of AMR1a; _________________ 1aWHO Global guidelines on the prevention of surgical site infection (2016), available at: http://www.who.int/gpsc/ssi-guidelines/en/
Amendment 56 #
Motion for a resolution
Recital D a (new)
Recital D a (new)
Da. whereas drug-resistant TB is the leading cause of death from AMR;
Amendment 66 #
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas ECDC/EFSA/EMA are currently working on a joint mandate to provide outcome indicators for consumption of antimicrobials and AMR in food-producing animals and in humans;
Amendment 68 #
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. whereas action to reduce veterinary antimicrobial use has been uneven across EU countries as the latest data from the European Medicine Agency shows1a; whereas some Member States have achieved significant reductions in the use of veterinary antimicrobials over a short period of time thanks to ambitious national policies, as illustrated by a series of fact-finding missions carried out by the European Commission Health and Food Audits and Analysis Directorate1aa; _________________ 1a http://www.ema.europa.eu/ema/index.jsp? curl=pages/news_and_events/news/2017/1 0/news_detail_002827.jsp∣ =WC0b01ac05 8004d5c1antimicrobials 1aa http://ec.europa.eu/food/audits- analysis/audit_reports/index.cfm
Amendment 75 #
Motion for a resolution
Recital E c (new)
Recital E c (new)
Amendment 85 #
Motion for a resolution
Paragraph 1
Paragraph 1
1. Believes that in order to take sufficient steps to tackle AMR, the One Health principle must play a central role, reflecting the fact that the health of people and animals and the environment are interconnected and that diseases are transmitted from people to animals and vice versa; stresses, therefore, that diseases have to be tackled in both people and animals, while also taking into special consideration the environment, which can be another source of resistant microorganisms;
Amendment 93 #
Motion for a resolution
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Emphasises that good husbandry practices aim to prevent infection and thereby the use of antibiotics; recalls that antibiotics should not be used to mask bad agricultural practices;
Amendment 97 #
Motion for a resolution
Paragraph 1 b (new)
Paragraph 1 b (new)
1b. Urges the Member States to consider the implementation of positive (tax exemptions for farmers) and negative (taxes on antibiotics sales such as now successfully practiced in Belgium and Denmark) tax incentives on antibiotics used in husbandry for non-therapeutic purposes;
Amendment 121 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls on the Commission to collect and report the volume of antibiotics produced by manufactures;
Amendment 134 #
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; and submit this data to the Global Antimicrobial Resistance Surveillance System (GLASS); furthermore, underlines the utmost importance of systemic collection of all the relevant and comparable data on the volume of sales and the use of veterinary antimicrobial medicinal products, which should be analysed and published by the European Medicine Agency in annual reports; considers that this practice should be made mandatory through European legislation as soon as possible;
Amendment 135 #
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 draft, in consultation with EMA, EFSA, ECDC and other key stakeholders, an EU priority pathogen list (PPL) for both humans and animals, thereby clearly setting future R&D priorities;
Amendment 137 #
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 and support Member States to put in place and monitor national targets for the surveillance and reduction of AMR/HAIs;
Amendment 156 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Urges the Commission to expand the role and funding of the ECDC, EFSA and EMA in the fight against AMR; believes that close collaboration between these EU agencies is paramount;
Amendment 163 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Calls on the Commission to expand its funding to EUCAST who deals with technical aspects of phenotypic in vitro antimicrobial susceptibility testing and functions as the breakpoint committee of EMA and ECDC;
Amendment 164 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Urges the European Commission to allocate additional funding specifically for research into non-therapeutic feed alternatives for application in husbandry in the 2021-2027 Multiannual Financial Framework (MFF);
Amendment 169 #
Motion for a resolution
Paragraph 6
Paragraph 6
6. Emphasises that infection prevention, biosecurity measures, active screening programs, and control practices are critical in the control of all infectious microorganisms as they reduce the need for antimicrobials and consequently opportunities for microorganisms to develop and spread resistance;
Amendment 171 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Urges Member States to develop ambitious national strategies to tackle AMR in the animal production sector including quantitative reduction targets for the use of veterinary antimicrobials whilst taking local circumstances into account; stresses that all sectors throughout the food chain should be involved in their implementation;
Amendment 172 #
6a. Stresses that compliance to infection control guidelines, integrating targets for infection rate reductions and supporting best practice all help address patient safety in the hospital environment;
Amendment 176 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Encourages Member States to prevent the spread of infection by resistant bacteria by implementing active screening programs with rapid diagnostic technologies in order to quickly identify patients infected with multi-drug resistant bacteria and to put in place appropriate infection control measures (e.g. patient isolation, cohorting and reinforced hygiene measures);
Amendment 177 #
Motion for a resolution
Paragraph 6 b (new)
Paragraph 6 b (new)
6b. Urges the Commission to present a new EU strategy on animal welfare as previously stated by the European Parliament, with the long-term aim of creating an Animal Welfare Law; urges the Commission to implement, without delay, the points outstanding from the European Union Strategy on the Protection and Welfare of Animals 2012- 2015;
Amendment 178 #
Motion for a resolution
Paragraph 6 c (new)
Paragraph 6 c (new)
6c. Calls on the Commission to create a harmonised system for labelling based on animal welfare standards and good animal husbandry practices as already envisaged in 20091a; _________________ 1a https://ec.europa.eu/food/sites/food/files/a nimals/docs/aw_other_aspects_labelling_i p-09-1610_en.pdf
Amendment 193 #
Motion for a resolution
Paragraph 8
Paragraph 8
8. Urges the Commission and Member States to create harmonised quality standards in EU-wide curriculafollowing the One Health approach in EU-wide curricula, to foster interdisciplinary education and proper stewardship for health professionals in relation to prescribing, dosage, use, and disposal of antimicrobials and AMR contaminated materials;
Amendment 225 #
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, in line with the 1999 SSC report, eliminate inducements, especially financial, for doctors orand veterinarians whoen prescribe theming antibiotics;
Amendment 243 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Recommends that the newly- created “One Health Network”, as well as the EU Joint Action on AMR and Healthcare-Associated Infections (EU- JAMRAI) should also involve other key relevant stakeholders apart from member states;
Amendment 246 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Calls on the Commission to take firm action against the illegal sale of antimicrobial products in the EU;
Amendment 263 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Calls on the European Commission to explore how best to leverage the potential of the European Reference Networks for rare diseases and to assess their possible role in AMR research;
Amendment 278 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13 a. Stresses that sub-lethal exposures of Escherichia coli and Salmonella enterica serovar Typhimurium to commercial formulations of glyphosate have been found to induce a changed response to antibiotics;
Amendment 279 #
Motion for a resolution
Paragraph 13 a (new)
Paragraph 13 a (new)
13 a. Stresses that release of pharmaceuticals into the environment is an important factor in the emergence of AMR both on a European and an international level;
Amendment 282 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13 b. Highlights that glyphosate, dicamba and 2,4-D, as well as co- formulants in commercial herbicides, induce a change in susceptibility of the potentially pathogenic bacteria E. coli and S. enterica to multiple antibiotics;
Amendment 283 #
Motion for a resolution
Paragraph 13 b (new)
Paragraph 13 b (new)
13 b. Calls on the Commission to appropriately address the release of pharmaceuticals into the environment and the emergence of AMR in its strategic approach to pharmaceuticals in the environment;
Amendment 285 #
Motion for a resolution
Paragraph 13 c (new)
Paragraph 13 c (new)
13 c. Notes that bacteria exposed to the herbicides respond differently to clinically relevant antibiotics and the frequency of herbicide-induced changes in antibiotics resistance in any approved use of herbicides and antibiotics, and the effects of the change escape regulatory oversight;
Amendment 297 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14 a. Calls on the Commission to ensure that aspects of environmental protection related to antibiotic products fall within the scope of the EU Good Manufacturing Practices (GMP) to address the release of antibiotics into the environment;
Amendment 304 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14 a. Calls on the Commission to consider criteria for combatting AMR in the next review of directive 2014/24/EU on public procurement;
Amendment 305 #
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14 b. Calls on the Commission and Member States to revise their Codes of Good Agricultural Practice and revise relevant best available techniques under the Industrial Emissions Directive (IED) to include provisions for the handling of manure containing antibiotics/AMR microorganisms;
Amendment 311 #
Motion for a resolution
Paragraph 14 c (new)
Paragraph 14 c (new)
14 c. Calls on the Commission to review and revise Best Available Techniques Reference (BREF) documents under the Industrial Emissions Directive (IED) relevant to emissions from the manufacturing plants of antibiotics;
Amendment 312 #
Motion for a resolution
Paragraph 14 d (new)
Paragraph 14 d (new)
14 d. Calls on the Commission to include pharmaceuticals in the watch lists for monitoring surface and groundwater under the Water Framework Directive (WFD) along with AMR in relevant microorganisms;
Amendment 317 #
Motion for a resolution
Paragraph 14 e (new)
Paragraph 14 e (new)
14 e. Calls on the Commission and Member States to ensure that environmental issues are introduced into the pharmacovigilance system for human pharmaceuticals and strengthened for veterinary pharmaceuticals particularly in relation to AMR;
Amendment 318 #
Motion for a resolution
Paragraph 14 f (new)
Paragraph 14 f (new)
14 f. Calls on the Commission and Member States to set quality standards (threshold values) or risk assessment requirements to ensure that the concentrations of relevant antibiotics and AMR microorganisms in manure, sewage sludge and irrigation water are safe before they can be spread on agricultural fields;
Amendment 321 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Welcomes that EFSA and EMA recently reviewed and discussed a number of alternatives to the use of antimicrobials in food-producing animals, some of which have been shown to yield promising results in the improvement of animal health parameters during experimental studies; recommends therefore to give new impetus to scientific research on alternatives and design an EU legislative framework that would stimulate their development and clarify the pathway for their approval;
Amendment 328 #
Motion for a resolution
Paragraph 16
Paragraph 16
16. Welcomes recent research projects into alternative antibiotic therapies such as bacteriophage therapy, such as the EU- funded Phagoburn project; notes that no bacteriophage therapies have been authorised at EU level so far; calls on the Commission to propose a legislative framework for bacteriophage therapy;
Amendment 337 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Encourages the European Medicines Agency (EMA) in collaboration with EFSA and ECDC to review all available information on the benefits and risks of older antimicrobial agents and to consider whether any changes to their approved uses are required;
Amendment 346 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18 a. Calls on the Commission to invest equally in the development of non- antibiotic alternatives for animal health including growth promoters as in the development of new molecules for the development of new antibiotics; stresses that new antibiotics shall not be used for animal health promotion or growth promotion and those industries receiving public funds for such development of new antibiotics shall stop distributing and/or using any antibiotics for animal health promotion and growth promotion;
Amendment 347 #
Motion for a resolution
Paragraph 18 a (new)
Paragraph 18 a (new)
18 a. Welcomes recent cross-border research projects into antimicrobial stewardship and the prevention of infection, such as the EU-funded i-4-1- Health Interreg project; calls on the Commission to increase research funding for measures to prevent healthcare- associated infections (HAI);
Amendment 350 #
Motion for a resolution
Paragraph 18 b (new)
Paragraph 18 b (new)
18 b. Calls on the Commission to further support its R&D effort on AMR, including global health infections defined in the Sustainable Development Goals, especially drug resistant TB as well as Malaria, HIV and NTDs, as part of the next EU Research Framework Programme, including by dedicating a specific mission in the Programme to the global fight against AMR;
Amendment 367 #
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 pull and push incentives to boost the development of new diagnostics, antibiotics, alternatives and vaccines;
Amendment 374 #
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 profitabilityat the business model for developing medicines is not suitable for antibiotic development since resistance can evolve over time and because they are meant to be used as a last resort; calls for incentives for this research and definition of the regulatory pathway;
Amendment 392 #
Motion for a resolution
Paragraph 23 a (new)
Paragraph 23 a (new)
23 a. Acknowledges the key role of pharmacists in raising awareness around the appropriate use of antimicrobials, as well as in the prevention of AMR; encourages Member States to expand their responsibilities by allowing exact quantity dispensing and enabling the administration of certain vaccines and rapid diagnostic tests within pharmacies;
Amendment 406 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24 a. Recognizes that AMR is a trans- border issue and that products enter Europe from all over the world and (a) Urges the European Commission to collaborate with third-parties, to reduce the use of antibiotics in husbandry and the environmental contamination; (b) Calls on the Commission to undertake collaborative research programmes with third countries to reduce the overuse of antibiotics; (c) Calls on the Commission in the context of Free Trade Agreements to ban the import of food-animal products where the animals have not been raised in line with EU standards, notably, with the ban on the use of antibiotic growth promoters;