Activities of Karin KADENBACH related to 2017/2254(INI)
Plenary speeches (2)
A European One Health Action Plan against Antimicrobial Resistance (debate) DE
A European One Health Action Plan against Antimicrobial Resistance (debate) DE
Reports (1)
REPORT on a European One Health Action Plan against Antimicrobial Resistance (AMR) PDF (545 KB) DOC (117 KB)
Amendments (105)
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 5 #
Draft opinion
Paragraph 1
Paragraph 1
1. Stresses that antimicrobial resistance (AMR) is a critical global health issue that requires commitment and willingness of the Member States to cooperate within the EU and at the international level and a proactive, coordinated action; underlines the importance of taking a holistic approach to tackling AMR through the one-health approach, by ensuring coherence and coordination between human health, animal health and the environment;
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 10 #
Motion for a resolution
Citation 16 a (new)
Citation 16 a (new)
– having regard to the report of the Committee on the Environment, Public Health and Food Safety on EU options for improving access to medicines (2016/2057(INI)),
Amendment 11 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Calls upon the Commission to support Member States in the development, assessment and implementation of national action plans against AMR, namely in what regards monitoring and surveillance systems and adequate support and incentive, taking into account the differences in reality among Member States;
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 17 #
Draft opinion
Paragraph 2
Paragraph 2
2. Calls on the Commission and the Member States to take an ambitious approach to ensuring that the targets set out in their respective Action Plans are fully and effectively achieved, and to strictly monitorAction Plans, containing measurable (clearly defined quantitative or qualitative) goals, benchmarks and effective measures to achieve these goals, are effectively implemented, and theat results thatstrictly monitored have been achieved;
Amendment 21 #
Motion for a resolution
Recital A a (new)
Recital A a (new)
Aa. whereas 50% of antibiotics prescriptions in humans are ineffective and 25% of consumption in humans is not well administrated; whereas 30% of hospitalised patients use antibiotics and multidrug resistant bacteria poses a particular threat in hospitals, nursing homes and among patients whose care requires devices such as ventilators and blood catheters;
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 34 #
Motion for a resolution
Recital B
Recital B
B. whereas the misuse of antibiotics is eroding their efficacy and leading to the spread of highly resistant bacteria that are especially resistant to last-line antibiotics; whereas according to data provided by the OECD, an estimated 700 000 deaths worldwide may be caused by AMR every year; whereas 25000 of these deaths will occur in the European Union and the rest outside the EU, therefore, cooperation in development policy and coordination and monitoring of AMR at international level is crucial;
Amendment 36 #
Motion for a resolution
Recital B
Recital B
B. whereas the misuse of antibiotics is eroding their efficacy and leading to the spread of highly resistant bacteriamicrobes that are especially resistant to last-line antibiotics; whereas according to data provided by the OECD, an estimated 700 000 deaths worldwide may be caused by AMR every year;
Amendment 38 #
Motion for a resolution
Recital B a (new)
Recital B a (new)
Ba. whereas AMR can cause up to 10 million deaths per year in 2050 if no action is taken; whereas 9 million of these estimated deaths would occur outside the EU, in developing countries, especially in Asia and Africa; whereas infections and resistance to AMR are contagious and spread easily, there is an urgent need for global action;
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 41 #
Motion for a resolution
Recital B b (new)
Recital B b (new)
Amendment 44 #
Draft opinion
Paragraph 3 a (new)
Paragraph 3 a (new)
3a. Reminds that food is one of the possible vehicles for transmission of resistant bacteria from animals to human beings and furthermore that drug- resistant bacteria can circulate in populations of human beings and animals, through water and the environment such as the risks for infection with resistant organisms by contaminated crops treated with antimicrobial agents or by manure, and farmyard run-offs into groundwater. Points out that in this context the spread is influenced by trade, travel and both human and animal migration;
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 47 #
Motion for a resolution
Recital C a (new)
Recital C a (new)
Ca. whereas several Member States are experiencing rapidly rising levels of multi-resistant fungi causing severely increased lengths of hospitalisations and mortality rates for infected patients; whereas the American Center for Disease Control and Prevention have raised awareness of the issue; whereas the specific issue is notably absent in the European One Health Action Plan against Antimicrobial Resistance;
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 49 #
Draft opinion
Paragraph 3 b (new)
Paragraph 3 b (new)
3b. Reminds that poor quality of medical and veterinary products with low concentrations of active ingredients and/or in conjunction with long-term use, encourage emergence of resistant microbes; calls therefore on the Commission and MS to improve/design laws that ensure that medicines are of assured quality, safe and effective and that their use will follow strict principles;
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 53 #
4. Calls for further research and development into new antimicrobials and encourages alternatives to be investigated, including the development of more sustainable farming systems based on less intensive farming models, underlying the need for incentives for EU and global coordination and cooperation on research programmes in order to stimulate the development of new antimicrobials, alternative therapies and (rapid) diagnostics;
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 60 #
Motion for a resolution
Recital E a (new)
Recital E a (new)
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 71 #
Motion for a resolution
Recital E b (new)
Recital E b (new)
Amendment 76 #
Draft opinion
Paragraph 5
Paragraph 5
5. Stresses that the prevention and control of infections in animals are key to tackling AMR in agriculture and therefore disease prevention must be the first step for legislation tackling AMR in agriculture, both to, via ensureing a high standard of animal welfare and, among others, and thus reduceing the need to resort to antibiotics; emphasises that the prescription-only status for antibiotics and the accountability of professionals in the various sectors, as well as the cooperation between the veterinarian and the livestock farmers, are key factors for success; believes that antibiotics should never be used as compensation for poor hygiene or inadequate animal husbandry;
Amendment 82 #
Draft opinion
Paragraph 5 a (new)
Paragraph 5 a (new)
5a. Highlights the value of vaccines in combating AMR; recommends integration of targets for life-long vaccination as element of veterinary national action plans on AMR;
Amendment 84 #
Draft opinion
Paragraph 5 b (new)
Paragraph 5 b (new)
5b. Welcomes the initiative of several MS to ban of the use of “last resort” antibiotics, normally used for human treatments, in farm animals;
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 #
Draft opinion
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Highlights that effective sanitation, hygiene and infection prevention measures help to reduce the incidence of infection;
Amendment 97 #
Draft opinion
Paragraph 7
Paragraph 7
7. Emphasises the crucial role of education and training programmes in raising awareness about antimicrobial resistance and the prudent use of antimicrobials in veterinary medicine for farmers and, veterinarians, professionals, and all those involved in livestock farming;
Amendment 103 #
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, so the coordination of national plans with specific marked objectives becomes crucial; highlights that the European Commission plays a key role in coordinating and monitoring national strategies; calls on the Commission to consider mandatory routine collection and submission of monitoring data at EU level and to establish indictors to measure progress in the fight against AMR;
Amendment 116 #
Motion for a resolution
Paragraph 2 a (new)
Paragraph 2 a (new)
2a. Remembers that health is a factor of productivity and competitiveness, as well as one of the issues of most concern for citizens; calls for national and European binding AMR objectives being part of the EU's political and economic agenda within the European Semester;
Amendment 121 #
Draft opinion
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Stresses that more cooperation between Member States, the Commission and the pharmaceutical industry is crucial in order to keep existing effective antimicrobials used in human and veterinary medicine on the market, explore alternative solutions to ensure availability of these antimicrobials on the market and promote its responsible use as well as preventive measures;
Amendment 133 #
Motion for a resolution
Paragraph 3
Paragraph 3
3. Stresses that establishing an effective surveillance system is essential to develop and inform any strategy aimed at rationalizing antimicrobial prescriptions and addressing AMR; recalls, however, that only a few countries have evaluated the extend of the overuse of antimicrobials; Calls on the Commission and the Member States to align surveillance, monitoring and reporting of AMR patterns and pathogens;
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 138 #
Draft opinion
Paragraph 9 a (new)
Paragraph 9 a (new)
9a. Notes that the livestock raised for food in the US are dosed with five times as much antibiotic medicine as farm animals in the UK, underlines therefore the importance of controls of meat imports to the EU;
Amendment 141 #
Draft opinion
Paragraph 10
Paragraph 10
10. Stresses that awareness of the issue should be raised at the highest political level, involving all Heads of State and all relevant UN and international organizations and aim for compromises and ambitious outcomes; emphasises that international cooperation involving sharing information, knowledge and best practices in tackling AMR is crucial in the context of the one- health approach for the benefit of human and animal health globally.;
Amendment 143 #
Motion for a resolution
Paragraph 3 a (new)
Paragraph 3 a (new)
Amendment 147 #
Draft opinion
Paragraph 10 a (new)
Paragraph 10 a (new)
10a. Refers to the Global Action Plan on Antimicrobial Resistance, endorsed by the World Health Assembly at the sixty- eight World Health Assembly in May 2015, to tackle antimicrobial resistance, including antibiotic resistance (WHA68/2015/REC/1, Annex 3.)
Amendment 152 #
Draft opinion
Paragraph 10 b (new)
Paragraph 10 b (new)
10b. Underlines that referring to the EFSA-EMA report “RONAFA” (http://www.efsa.europa.eu/en/efsajournal /pub/4666),safe and nutritionally balanced feed are effective preventive measures to help animals to cope with pathogens by enhancing the overall animal health and welfare status through specific feeding strategies, feed composition, feed formulations or feed processing.
Amendment 154 #
Draft opinion
Paragraph 10 c (new)
Paragraph 10 c (new)
10c. Underlines that without harmonised and immediate action on a global scale the world is heading towards a post-antibiotic era in which common infections could once again kill;
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 170 #
Motion for a resolution
Paragraph 6 a (new)
Paragraph 6 a (new)
6a. Highlights the need for an EU data collection system on the correct use of all antibiotics; asks for the development of protocols for prescription and use of antibiotics at an EU level, recognising the responsibility of veterinarians and primary care doctors among others; furthermore, asks for the compulsory collection, at a national level, of all antibiotic prescriptions, and their registration in a database controlled and coordinated by experts in infections to spread the knowledge on the best use of them;
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 189 #
Motion for a resolution
Paragraph 7 a (new)
Paragraph 7 a (new)
7a. Calls on the Member States to develop public health messages to raise public awareness regarding the link between infections and personal hygiene; emphasises that an effective tool to reduce the usage of antimicrobials is to stop infections from spreading in the first place; encourages in this regard the promotion of self-care initiatives
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 199 #
Motion for a resolution
Paragraph 8 a (new)
Paragraph 8 a (new)
8a. Emphasises that one third of prescriptions are made in primary care, so this sector should be considered as a priority in the use protocols; stresses the need for specialists in infectious diseases for the elaboration of these protocols, their control and follow-up; calls on the European Commission to draft guidelines for their use in human health; calls on the Member States to review all existing protocols, especially for prophylactic use during surgery; welcomes current projects at national level such as the Pirasoa Project, as an example of good practice in rational use in primary care and hospitals; encourages mechanisms to share best practice and protocols;
Amendment 214 #
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; stresses that rapid diagnostic tests are only available across the whole country of 40% of OECD countries; 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, given the long-term benefits of preventing the unnecessary use of antimicrobials;
Amendment 234 #
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; the supply of veterinary antimicrobials by veterinarians should be restricted to the amount required for treatment of the animals under their care, and only once a veterinary diagnosis has been established following a clinical examination of the animal. The routine prophylactic and metaphylactic use of antimicrobials in groups of food-producing animals should be prohibited.
Amendment 239 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Many antimicrobials are used in both humans and animals. Some of those antimicrobials are highly critical for preventing or treating life-threatening infections in humans and their use on animals should be prohibited. In order to preserve as long as possible the efficacy of those antimicrobials in the treatment of infections in humans, it is necessary to reserve those antimicrobials for humans only.
Amendment 242 #
Motion for a resolution
Paragraph 11 a (new)
Paragraph 11 a (new)
11 a. Warns that the FAO estimates that the use of antibiotics and pesticides in agriculture will dramatically increase; calls on the European Commission and Member States to study new methods to eliminate the residues of pesticides and antibiotics in food;
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 247 #
Motion for a resolution
Paragraph 11 b (new)
Paragraph 11 b (new)
11 b. Recalls that, according to current legislation, antimicrobials are prohibited from being used as growth / performance enhancers in animals; highlights, however, that there is evidence of the abuse for the purposes of prophylaxis; calls on the European Commission to ban the use of antibiotics and medicated feed for prophylaxis purpose except for clearly justified cases prescribed and controlled by a veterinarian; calls for its control and the establishment of sanctions; furthermore, calls for a ban of the use of last-line antibiotics, such as Colistin and Carbapenems, in the veterinary field;
Amendment 250 #
Motion for a resolution
Paragraph 11 c (new)
Paragraph 11 c (new)
11 c. Stresses that the sanitation and hygiene of farms is fundamental; asks the Commission to develop guidelines on the use of antibiotics in animals and the hygiene conditions of farms; calls on the Member States to draw up specific plans and to strengthen control over sanitary conditions;
Amendment 261 #
Motion for a resolution
Paragraph 12 a (new)
Paragraph 12 a (new)
12 a. Stresses that affordability and broader access are key priorities and that access should be ensured for necessary new diagnostics and medicines; highlights that models for innovation, procurement, delivery and financing of treatments established for HIV/AIDS, malaria and TB could serve as a blueprint for improving access to antibiotics; calls on the European Commission to present a European plan for the eradication of the Hepatitis C, and a European Strategy for HIV/AIDS, malaria and TB;
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 274 #
Motion for a resolution
Paragraph 13
Paragraph 13
13. Highlights that the pollution of the environment by human and veterinaryanimal antibiotic residues is an emerging problem and encourages further research into 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 294 #
Motion for a resolution
Paragraph 14
Paragraph 14
14. Calls for a stricter environmental risk assessments as part of the marketing authorisation process for antimicrobials;
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 298 #
Motion for a resolution
Paragraph 14 a (new)
Paragraph 14 a (new)
14 a. Urges the Commission and the Member States to address the issue of rapidly rising levels of multi-drug resistant fungi by reviewing the usage of fungicides in the agricultural and industrial sector;
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 319 #
Motion for a resolution
Paragraph 15
Paragraph 15
15. Points out that with an investment of EUR 1.3 billion in AMR research, Europe is a leader in this domain, and that EU achievements include the launch of the New Drugs for Bad Bugs (ND4BB) programme5 and the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR)6 ; notes with concern that no truly new antimicrobial classes have been introduced in recent years; _________________ 5 6underlines the need for efficiency and coordination of research actions; welcomes therefore initiatives such as the ERA-NET for establishing synergies between the Joint JPIAMR and Horizon 2020/FP9; highlights that more than 20 new classes of antibiotics were developed until the 1960s and notes with concern that no truly new antimicrobial classes have been introduced in recent years; _________________ 5 http://www.imi.europa.eu/content/nd4bb http://www.imi.europa.eu/content/nd4bb 6 http://www.jpiamr.eu http://www.jpiamr.eu
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 322 #
Motion for a resolution
Paragraph 15 a (new)
Paragraph 15 a (new)
15 a. Remembers that the traditional generation of antibiotics, based on a series of modification techniques on antibiotics obtained from nature, is exhausted and that R&D investments to create a new generation should break the traditional antibiotic paradigm; welcomes new techniques that have already been developed such as monoclonal antibodies that reduce the virulence of the bacteria, not killing it, but rendering it useless;
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 339 #
Motion for a resolution
Paragraph 17 a (new)
Paragraph 17 a (new)
17 a. Encourages the Commission to introduce a fast-track procedure where antimicrobials approved for industrial or agricultural purposes suspected of having a severe negative impact on antimicrobial resistance can be temporarily prohibited from usage until further studies on the impact of the antimicrobial have been carried out;
Amendment 340 #
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, in health-associated infections (HAI), in new antimicrobial drug resistance mechanisms, in developing new therapeutic diagnostics and preventing measures, including vaccines, and in drug delivery technologies and approaches, such as exploiting host immunity to kill resistant microbes; points out that the study of mechanisms of antibiotic resistance and the development of medical devices for the aetiology of diseases are key areas for adequate use, and appropriate prescribing of antibiotic;
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 354 #
Motion for a resolution
Paragraph 19 a (new)
Paragraph 19 a (new)
19 a. Believes in the need for different models of collaboration led by the public sector and with the involvement of industry; recognises that the capacities of industry play a key role in R&D of AMR; notwithstanding the above, stresses that further public priorisation and coordination are required for R&D in this urgent topic; therefore calls on the European Commission to launch a Public Platform for publicly funded R&D projects in AMR and the coordination of all R&D actions;
Amendment 357 #
Motion for a resolution
Paragraph 19 b (new)
Paragraph 19 b (new)
19 b. Welcomes the conclusions of the “WHO, WIPO, WTO Joint Technical Symposium on Antimicrobial Resistance: how to foster innovation, access and appropriate use of antibiotics"4a , where new R&D models were discussed to incentivize R&D while delinking the profitability of an antibiotic from volumes sold; _________________ 4a http://www.wipo.int/publications/en/detail s.jsp?id=4197
Amendment 358 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission and the Member States to support the implementation ofexplore new economic models, pilot projects and incentives to boost the development of new diagnostics, antibiotics, alternatives and vaccine, vaccines and medical devices, since the market has failed to sufficiently support the development of new products; recalls that new business models need to be sustainable, needs-driven, evidence-based and guided by the principles of affordability, effectiveness, efficiency and equity, to the benefit of patients;
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 377 #
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; recalls for incentives for this research and definition of the regulatory pathwathat, unlike treatments for chronic diseases, antibiotics are temporary medicines which have the potential to cure the patient, meaning that the development of new antibiotics cannot be linked to the usual economic model of the industry;
Amendment 382 #
Motion for a resolution
Paragraph 22 a (new)
Paragraph 22 a (new)
22 a. Remembers that both, the European Parliament and the Council have asked for a review of current incentives (i.e orphan medicines regulation), due to their misused and high final prices; calls therefore on the European Commission to analyse current R&D incentive model, including the Transferable Market Exclusivity Model, in order to design new ones and define the regulatory pathway;
Amendment 387 #
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; highlights that guaranteeing affordability and access to quality antibiotics must be the final aim of R&D and incentives;
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 396 #
Motion for a resolution
Paragraph 23 b (new)
Paragraph 23 b (new)
23 b. Welcomes the WHO ranking list of 20 Worst Antibiotic-Resistant Pathogens5a; calls for urgent R&D projects on this priority list of antibiotic- resistant bacteria in order to create drugs to fight them; highlights however that research on new drugs is not the only action needed and that misused and over- use must be tackled in both humans and animals; _________________ 5a http://www.who.int/mediacentre/news/rele ases/2017/bacteria-antibiotics-needed/en/
Amendment 398 #
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 high economic burden, AMR requires urgent and coordinated global and intersectoral action; therefore, asks for a clear commitment, on the part of the EU and the Member States, to launch a crosscutting global strategy to combat AMR, covering policy areas such as international trade, development and agriculture;
Amendment 407 #
Motion for a resolution
Paragraph 24 a (new)
Paragraph 24 a (new)
24 a. Takes note of the report “Tackling drug-resistant infections globally: final report and recommendations"6a that estimates that taking global action on AMR will cost 40 billion USD over a 10- year period, which is tiny in comparison to the cost of inaction and it is also a very small fraction of what the G20 countries spend on healthcare today: around 0.05 per cent; calls on the European Commission to analyse the possibility to impose a tax on the industry for public health in the framework of its social responsibility; _________________ 6ahttps://amr- review.org/sites/default/files/160518_Fina l%20paper_with%20cover.pdf
Amendment 411 #
Motion for a resolution
Paragraph 25 a (new)
Paragraph 25 a (new)
25 a. Welcomes the new WHO guidelines on the use of medically important antimicrobials in food- producing animals7a; highlights that in some countries, approximately 50-70% of total consumption of medically important antibiotics is in the animal sector, largely for growth promotion in healthy animals; asks, in the framework of the One Health approach, to include this topic in the trade policy of the EU and in negotiations with international organisations as the WTO and associated or third countries, shaping a global policy in order to ban the use of antibiotics for fattening healthy animals; _________________ 7a http://www.who.int/foodsafety/areas_work /antimicrobial- resistance/cia_guidelines/en/
Amendment 414 #
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 % of deaths caused by AMR are 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 AMR, and to create partnerships such as PRIMA or EDCTP for international R&;D projects on health, comprising different geographical regions and the most sensitive health topics such as AMR, vaccines, cancer and access to medicines;
Amendment 419 #
Motion for a resolution
Paragraph 26 a (new)
Paragraph 26 a (new)
26 a. Underlines the importance of European initiatives as the ECDC programmes for infectious diseases such as AIDS, TB and malaria; points out that these initiatives are examples of good practices of the responsiveness and good functioning of the EU in view of the need for new antibiotics, and that the ECDC should have a key role in the prioritisation of R&D needs, in the coordination of actions and involvement of all actors, in enhancing cross-sectorial work and in capacity building through R&D networks;
Amendment 421 #
Motion for a resolution
Paragraph 26 b (new)
Paragraph 26 b (new)
26 b. Stresses that there is a problem of emergence of multiresistant bacteria, resistant to several antibiotics at the same time that can eventually become superbacteria resistant to all available antibiotics, including last line antibiotics; highlights the need for a database on these multiresistant bacteria as AIDS, TB, malaria, gonorrhoea, Escherichia coli, and other drug-resistant bacteria;
Amendment 423 #
Motion for a resolution
Paragraph 26 c (new)
Paragraph 26 c (new)
26 c. Stresses the enormous challenges of affordability and access to antimicrobials and their impact on public health; highlights that TRIPS flexibilities should be reaffirmed; welcomes the Davos Declaration on Combating Antimicrobial Resistance launched at the World Economic Forum in Davos on January 2016, where pharmaceutical, biotechnology and diagnostics industries “recognise the success of programmes to improve global access to drugs in HIV, TB, and malaria and call for a similar collaborative effort to address issues of access to antibiotics"8a; _________________ 8ahttps://amr- review.org/sites/default/files/Industry_Dec laration_on_Combating_Antimicrobial_R esistance_UPDATED%20SIGNATORIES _MAY_2016.pdf
Amendment 431 #
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, for the appropriate use of antibiotics;
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;