76 Amendments of Lynn BOYLAN 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 46 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas the lack of access to effective antibiotics in developing countries still causes more deaths than AMR, understanding that actions to address AMR which over-focus on restricting access to antibiotics may exacerbate an already deep crisis in relation to access to medicines, which today causes more than one million deaths in children under five; actions to address AMR must aim to ensure sustainable access for all, meaning access for those in need but excess for none.
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 58 #
Motion for a resolution
Recital E
Recital E
E. whereas the World Bank in its abovementioned report has warned that by 2050, drug-resistant infections could cause global economic damage on a par with the 2008 financial crisis; and push more than 28 million people into extreme poverty.
Amendment 61 #
Motion for a resolution
Recital E a (new)
Recital E a (new)
Ea. whereas AMR must be seen and understood as a threat to both human, animal and planetary health and a direct threat to the achievement of several of the Sustainable Development Goals outlined in the Agenda 2020 on universal sustainable development including, but not limited to, SDG1, SDG2, SDG3 and SDG6.
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 70 #
Motion for a resolution
Recital E b (new)
Recital E b (new)
Eb. whereas the often-cited figure of 25,000 deaths in Europe and related costs of over 1.5 Billion euros owing to AMR dates back to 2007 and that continuously updated information on the real burden of AMR is necessary; emphasises the magnitude of the problem will also underline the clear need for a European One Health Action Plan Against AMR;
Amendment 84 #
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 consideration the food chain and the environment, which can be another source of resistant microorganisms;
Amendment 110 #
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 considerensure mandatory routine collection and submission of monitoring data at EU level and to establish indictors to measure progress in the fight against AMR in all One Health domains at EU level;
Amendment 119 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Calls on the Commission to establish indicators to measure and compare progress in the fight against AMR and to encourage the evaluation of the standardised data;
Amendment 124 #
Motion for a resolution
Paragraph 2 b (new)
Paragraph 2 b (new)
2b. Stresses the need for a time frame for the European One Health Action Plan; calls on the Commission and the Member States to include measureable and time-bound objectives and targets in the European One Health Action Plan and in national action plans to enable benchmarking;
Amendment 126 #
Motion for a resolution
Paragraph 2 c (new)
Paragraph 2 c (new)
2c. Calls on the Commission to coordinate and monitor national strategies to enable sharing of best practices between Member States;
Amendment 128 #
Motion for a resolution
Paragraph 2 d (new)
Paragraph 2 d (new)
2d. Calls on the Commission to conduct and publish a mid-term evaluation and ex-post evaluation of the One Health Action Plan and to involve all relevant stakeholders in the evaluation procedure;
Amendment 129 #
Motion for a resolution
Paragraph 2 e (new)
Paragraph 2 e (new)
2e. Regrets that the EU One Health Action Plan Against AMR lacks any allocation of resources as well as a more ambitious use of legislative tools; calls on the Commission to be more ambitious in any future Action Plan it develops and to make more determined efforts to implement it in its entirety.
Amendment 131 #
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, to encourage more holistic data collections and to submit data to the Global Antibiotics Resistance Surveillance System (GLASS); calls on the Commission to draft, in consultation with EMA, EFSA, ECDC and other key stakeholders independent from the pharmaceuticals industry, an EU priority pathogen list (PPL) for both humans and animals, thereby clearly setting future R&D priorities; calls on the Commission to encourage and support Member States to adopt and monitor national targets for the surveillance and reduction of AMR/HAIs;
Amendment 158 #
Motion for a resolution
Paragraph 5
Paragraph 5
5. Urges the Commission to expand the role and funding of the ECDC in the fight against AMR and healthcare associated infections (HAI);
Amendment 161 #
Motion for a resolution
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Urges the Commission and the Member States to follow the example of Sweden and adopt a nationally suitable target for the desired ratio of antibiotic prescriptions per 1000 habitants against which to measure progress; calls on the Commission to make this standard practice in all EU Member States.
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 180 #
Motion for a resolution
Paragraph 7
Paragraph 7
7. Calls on the Commission and the Member States to develop public health messages to raise public awareness and in doing so promote a change in behaviour towards the use of antibiotics; underlines the importance of promoting ‘health literacy’, since it is crucial that patients understand healthcare information and are able to follow treatment instructions accurately; calls for the scaling up of preventive measures, including hygiene to reduce the amount of antibiotics currently required to treat infections and medical procedures; stresses that awareness on the perils of self-medication and over- prescription should be a core component of this preventive strategy, and deprescription by health care professionals a possible solution;
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 203 #
Motion for a resolution
Paragraph 9
Paragraph 9
9. Is aware that health professionals often need to make quick decisions on therapeutic indication for antibiotic treatment; notes that rapid diagnostic tests can help to support theseffective and accurate decisions; -making;
Amendment 211 #
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 Member States to propose novel incentives for the industry to developto develop low- cost, effective and efficient testing methods and calls on health insurance carriers to cover the extra cost arising from the use of RDTthat follow global health priorities and delink the cost of R&D from price and volume sales of the end product and calls on global health actors and reimbursement systems in countries to develop solutions whereby the introduction and broad uptake of such diagnostics is ensured, given the long-term benefits of preventing the unnecessary use of antimicrobials; calls on the Commission to encourage the uptake of RDT;
Amendment 230 #
Motion for a resolution
Paragraph 11
Paragraph 11
11. Calls on the Commission and the Member States to restrict or stopmove all misaligned financial incentives that undermine conservation efforts, including by banning the sale of antibiotics by those doctors or veterinarians who also prescribe them, and to remove incentives for doctors and veterinarians to prescribe antibiotics;
Amendment 251 #
Motion for a resolution
Paragraph 12
Paragraph 12
12. Highlights the value of vaccines in combating AMR; recommends integration of targets for life-long vaccination as a key element of national action plans on AMR;vaccination in the population, particularly in vulnerable groups, as a key element of national action plans on AMR; calls on the Commission and Member States to ensure greater global uptake and coverage of crucial vaccines such as the Pneumococcal vaccine, including by tackling affordability barriers in middle income countries.
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 270 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Highlights that the pollution of the environment by human and, veterinary, agricultural and industrial antibiotic residues is an emerging global problem and encourages further research intothat requires coherent policy measures to avoid the spreading of AMR between ecosystems, animals and people; stresses the need for further research into transmission dynamics and the relative impact of this pollution on AMR;
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 288 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls for environmental risk assessments as part of the marketing authorisation process for antimicrobials;, as well as for older products already on the market; and calls on the Commission to address environmental pollution in the EU principles and guidelines for good manufacturing practices.
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 300 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14 a. Calls for the introduction of good manufacturing practices and green procurement rules regarding the production and distribution of pharmaceuticals;
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 308 #
Motion for a resolution
Paragraph 14 b (new)
Paragraph 14 b (new)
14 b. Urges the Commission to formally include civil society in One Health discussions, for example by setting up and funding a dedicated stakeholder network;
Amendment 310 #
Motion for a resolution
Paragraph 14 c (new)
Paragraph 14 c (new)
14 c. Stresses that not all Member States possess sufficient resources to develop and implement comprehensive national AMR strategies, urges the Commission to provide Member States with clear information about available EU sources to tackle AMR and to make available more dedicated funding for this purpose;
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 313 #
Motion for a resolution
Paragraph 14 d (new)
Paragraph 14 d (new)
14 d. Urges the Commission to effectively deploy available legislation in all AMR-related areas to ensure that the threat is being tackled in all policies;
Amendment 316 #
Motion for a resolution
Paragraph 14 e (new)
Paragraph 14 e (new)
14 e. Underlines the importance of a life cycle assessment approach, from production and prescription to the management of pharmaceutical waste, stresses the need for more alternatives to be explored regarding the disposal of antibiotics, such as gasification;
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 344 #
Motion for a resolution
Paragraph 18
Paragraph 18
18. Calls on the Commission to increase funding for early research in epidemiology and immunology of AMR pathogens, in particular the pathways of transmission between animals and humans and the environment;
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 351 #
Motion for a resolution
Paragraph 19
Paragraph 19
19. Calls on the Commission and the Member States to promote early and continuous dialogue with all stakeholders to elabordevelop appropriate incentives for research and development (R&D) in the field of AMR; acknowledges that there is no ‘one-size- fits-all’ approach; strongly underlines that while all stakeholders should be consulted, key beneficiaries of any new financial and regulatory incentives should not be asked to design such incentives as was the case in the Innovative Medicines Initiative project DRIVEAB;
Amendment 362 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission and the Member States to support the development and implementation of new economic models, pilot projects and incentives that delinks the cost of R&D from sales and price of end product in accordance with the principles outlines in the UNGA Declaration on AMR adopted by all Member States in 2016 to boost the development of new diagnostics, antibiotics, alternatives to using antimicrobials, medical devices, and vaccines;
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 373 #
Motion for a resolution
Paragraph 21 a (new)
Paragraph 21 a (new)
21 a. Encourages Member States to promote alternative reimbursement systems to facilitate the uptake of innovative technologies in national healthcare systems.
Amendment 376 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Notes the hesitant approach of the industry to develop ‘last-line’novel classes of antibiotics against bacteria that are resistant to all other antibiotics owing to expected low profitability; calls for incentives for this research andthe most resistant bacteria as identified by the Priority Pathogens List developed by the WHO, owing to expected low profitability; calls for the development of appropriate incentives for this research which ensures affordable access and enable implementation of public health driven conservation measures; and a clear definition of the regulatory pathway for novel classes of antibiotics;
Amendment 386 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. CNotes that excess prescription is directly linked to a rise in AMR; calls on the Commission and Member States to develop new incentive models that delink payment from price and prescribing volume in accordance with the UNGA Declaration on AMR from 2016;
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 403 #
Motion for a resolution
Paragraph 24
Paragraph 24
24. Recalls that owing to the complexity of the problem, its cross-border dimension, the severe consequences for human and animal health and the environment and the high economic burden, AMR requires urgent and coordinated global and intersectoral action;
Amendment 409 #
Motion for a resolution
Paragraph 25
Paragraph 25
25. Welcomes the WHO Global Action Plan (GAP) on AMR, which was adopted unanimously in May 2015 by the 68th World Health Assembly; stresses the need for global, European and national action plans to be in line;
Amendment 413 #
Motion for a resolution
Paragraph 26
Paragraph 26
26. Notes that AMR is of serious concern in many poverty-related and neglected diseases (PRNDs), including HIV/AIDS, malaria and tuberculosis (TB); highlights that about 29 % ofHighlights that about a third of the 10 million estimated deaths caused by AMR arby 2050 will be due to drug-resistant TB, and calls on the Commission and the Member States to increase their support to research for health tools to address PRNDs affected by AMRfor TB, including by supporting the Life Prize which pilots new collaborative innovation models for TB;
Amendment 427 #
Motion for a resolution
Paragraph 27
Paragraph 27
27. Calls on the Commission to advocate EU standards and measures for tackling AMR in trade agreementsdo a consultation with relevant stakeholders on how EU standards and measures for tackling AMR can be appropriately included in trade agreements and work through the WTO to raise the issue of AMR;
Amendment 438 #
Motion for a resolution
Paragraph 28
Paragraph 28
28. Calls on the Commission and the Member States to strengthen measures to combat illegal practices related to the trade and use of antimicrobialproduction, trade, use and disposal of antimicrobials; emphasizes that actors involved in the life-cycle chain of antimicrobials need to take responsibility for their actions;
Amendment 440 #
Motion for a resolution
Paragraph 28
Paragraph 28
28. Calls on the Commission and the Member States to strengthen measures to combat illegal practices related to the trade and use of substandard and falsified antimicrobials;
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;
Amendment 444 #
Motion for a resolution
Paragraph 29
Paragraph 29
29. Calls on the Commission to work towards continued high-level political attention and commitment to AMR action, including in UN forums, the G7 and the G20; highlights the opportunity for the European scientific bodies, like ECDC, to take global stewardship roles; calls on the Commission to advocate collaboration between the EU and international organisations including WHO, FAO, and OIE;