49 Amendments of Piernicola PEDICINI related to 2017/2254(INI)
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 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 108 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Stresses that the appropriate and prudent use of antimicrobials is essential to limiting the emergence of AMR in human healthcare, animal husbandry and aquaculture; stresses that there are considerable differences in the way Member States handle and address AMR; calls on the Commission to consider mandatory routine collection and submission of monitoring data at EU level, making them also available to the public, and to establish indictors to measure progress in the fight against AMR;
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 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 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 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 217 #
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 to propose incentives for the industry to develop effective and efficient testing methods and calls on health insurance carriers to cover the extra cost arising from the use of RDT, making sure that patients do not have to bear that cost, given the long-term benefits of preventing the unnecessary use of antimicrobials;
Amendment 233 #
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;
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 244 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11a. Calls on the Member States to prohibit the sale of antibiotics without a doctor's or veterinarian's prescription;
Amendment 254 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. HighlightConsiders theat value of vaccinesccines whose efficacy and safety have been scientifically tested can play a major role in combating AMR; recommends integration of targets for life-long vaccination as a key element of national action plans on AMR;
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 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 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 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 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 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 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 336 #
Motion for a resolution
Paragraph 17
Paragraph 17
17. Encourages the European Medicines Agency (EMA) to review all available information on the benefits and risks of older antimicrobial agents, including antibiotics in combination, and to consider whether any changes to their approved uses are required;
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 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 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 441 #
Motion for a resolution
Paragraph 28 a (new)
Paragraph 28 a (new)
28 a. Notes the importance of universal access to existing antibiotics, in order to ensure targeted treatment with specific antibiotics, which should be available in order to avoid the misuse of unsuitable antibiotics and the overuse of broad- spectrum antibiotics;
Amendment 443 #
Motion for a resolution
Paragraph 28 b (new)
Paragraph 28 b (new)
28 b. Calls on the Commission to take the global lead in advocating for evidence-based best practice models for early diagnosis to tackle AMR;