2017/2254(INI) European One Health action plan against antimicrobial resistance (AMR)
Lead committee dossier:
Progress: Procedure completed
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | ENVI |
KADENBACH Karin ( S&D)
|
SOMMER Renate ( PPE),
PIECHA Bolesław G. ( ECR),
FEDERLEY Fredrick ( ALDE),
PEDICINI Piernicola ( EFDD),
MÉLIN Joëlle ( ENF)
|
| Committee Opinion | AGRI |
Beata GOSIEWSKA ( ECR),
Ricardo SERRÃO SANTOS ( S&D)
|
|
| Committee Opinion | ITRE |
WIERINCK Lieve ( ALDE)
|
Soledad CABEZÓN RUIZ ( S&D),
Rolandas PAKSAS ( EFDD),
Anna ZÁBORSKÁ ( PPE)
|
Lead committee dossier:
Legal Basis:
RoP 54
Legal Basis:
RoP 54Subjects
Events
2019/03/11
EC - Commission response to text adopted in plenary
Documents
2018/09/13
EP - Results of vote in Parliament
Documents
2018/09/13
EP - Decision by Parliament
Details
The European Parliament adopted by 589 votes to 12 with 36 abstentions, a resolution on a European One Health Action Plan against Antimicrobial Resistance (AMR).
Members noted that the excessive and incorrect use of antibiotics and poor infection control practices in both human and veterinary medicine have progressively rendered antimicrobial resistance (AMR) a massive threat to human and animal health. The misuse of antibiotics is eroding their efficacy. In terms of human health, 50 % of antibiotic prescriptions written for humans are ineffective.
Stressing that the correct and prudent use of antimicrobials is essential to limiting the emergence of AMR, Parliament made the following key observations and recommendations:
The EU as a best-practice region : Members stressed that the One Health principle must play a central role in tackling AMR, reflecting the fact that the health of people and animals and the environment are interconnected. They called for measurable and binding AMR objectives with ambitious targets , both in the European One Health Action Plan and in national action plans, to enable benchmarking.
Parliament asked the Commission and Member States to restrict the sale of antibiotics by the human and animal health professionals who prescribe them and to remove any incentives – financial or otherwise – for the prescription of antibiotics, while continuing to ensure sufficiently rapid access to emergency veterinary medicine.
Some of the many antimicrobials used in both humans and animals are critical for preventing or treating life-threatening infections in humans. Members considered that the use of these antimicrobials on animals should be banned . These antimicrobials should be reserved for the treatment of humans alone in order to preserve their efficacy.
The Commission should specify which antibiotics are to be reserved for the treatment of certain infections in humans. In addition, Members called for: (i) firm action against the illegal sale of antimicrobial products or their sale without a doctor’s or veterinarian’s prescription in the EU; (ii) the promotion of public health messages regarding the responsible use of antibiotics, particularly prophylactic use.
With regard to animal health , Parliament called for the phasing out of the routine prophylactic and metaphylactic use of antimicrobials in groups of farm animals and called for the use of last-resort antibiotics to be banned altogether in food-producing animals.
With regard to prophylactic use in humans , Parliament called on Member States to review all existing protocols, especially for prophylactic use during surgery. It cited the examples of good practice, such as the PIRASOA programme, and encouraged the development of mechanisms through which to share best practices and protocols.
Members believed that requirements to ensure that labelling makes reference to antibiotic use would improve consumer knowledge and enable consumers to make a more informed choice. They called on the Commission to create a harmonised system for labelling based on animal welfare standards and good animal husbandry practices.
Boosting research : Members felt that, in order to encourage research into new antimicrobials, incentives are needed . They called on the Commission to establish an EU priority pathogen list (PPL), taking into account the WHO’s global PPL, for both humans and animals, thereby clearly establishing future research and development priorities.
The resolution also called for:
the launch a public platform for publicly funded R&D projects in AMR and for the coordination of all R&D actions; a fast-track procedure whereby the use antimicrobials approved for industrial or agricultural purposes but suspected of having a severe negative impact on AMR may be temporarily prohibited until further studies have been carried out; the development of non-antibiotic alternatives for animal health, including growth promoters, and in the development of new molecules for the development of new antibiotics.
Shaping the global agenda : Parliament asked for a clear commitment on the part of the EU and the Member States to launching a crosscutting global strategy to combat AMR, covering policy areas such as international trade, development and agriculture. It noted that the use of antibiotics as growth promoters in food-producing animals has been banned in the EU since 2006, but that in countries outside the EU antibiotics can still be used in animal feed as growth promoters. It called on the Commission to include a clause in all free trade agreements stipulating that food imported from third countries must not have been produced using antibiotics as growth promoters.
Lastly, Members called on the Commission to implement collaborative research programmes with third countries to reduce the overuse of antibiotics.
Documents
2018/09/13
EP - End of procedure in Parliament
2018/09/12
EP - Debate in Parliament
Documents
2018/07/12
EP - Committee report tabled for plenary
Details
The Committee on the Environment, Public Health and Food Safety adopted an own-initiative report by Karin KADENBACH (S&D, AT) on a European One Health Action Plan against Antimicrobial Resistance (AMR).
Members noted that the excessive and incorrect use of antibiotics and poor infection control practices in both human and veterinary medicine have progressively rendered antimicrobial resistance (AMR) a massive threat to human and animal health. The misuse of antibiotics is eroding their efficacy. In terms of human health, 50 % of antibiotic prescriptions written for humans are ineffective.
Stressing that the correct and prudent use of antimicrobials is essential to limiting the emergence of AMR, the committee made the following key observations and recommendations:
The EU as a best-practice region : Members stressed that the One Health principle must play a central role in tackling AMR, reflecting the fact that the health of people and animals and the environment are interconnected. They called for measurable and binding AMR objectives with ambitious targets , both in the European One Health Action Plan and in national action plans, to enable benchmarking. They also called on the Commission to publish a mid-term evaluation and ex-post evaluation of the One Health Action Plan.
Some of the many antimicrobials used in both humans and animals are critical for preventing or treating life-threatening infections in humans, and Members considered that the use of these antimicrobials on animals should tbe banned . These antimicrobials should be reserved for the treatment of humans alone in order to preserve their efficacy. The Commission should specify which antibiotics are to be reserved for the treatment of certain infections in humans. In addition, Members called for the promotion of public health messages regarding the responsible use of antibiotics, particularly prophylactic use.
In terms of animal health , the report noted that high-density farming may involve antibiotics being improperly fed to livestock on farms to promote faster growth, and that they are also widely used for prophylactic purposes. It called for the phasing out of the routine prophylactic and metaphylactic use (i.e. treating a group of animals when only one shows signs of infection) of antimicrobials in groups of farm animals and called for the use of last-resort antibiotics to be banned altogether in food-producing animals . Instead, Members stressed the importance of good animal husbandry, hygiene practices, farm management and investments in these areas The Commission was urged to present a new EU strategy on animal welfare.
With regard to prophylactic use in humans , the committee called on Member States to review all existing protocols, especially for prophylactic use during surgery. It cited the examples of good practice, such as the PIRASOA programme, and encouraged the development of mechanisms through which to share best practices and protocols.
Boosting research : Members felt that, in order to encourage research into new antimicrobials, incentives are needed , including longer periods of protection for technical documentation on new medicines, commercial protection of innovative active substances, and protection for significant investments in data generated to improve an existing antimicrobial product or to keep it on the market. They called on the Commission to analyse current R&D incentive models, including the ‘transferable market exclusivity’ model, with a view to designing new ones and defining the regulatory pathway. Members also called for:
the launch a public platform for publicly funded R&D projects in AMR and for the coordination of all R&D actions; a fast-track procedure whereby the use antimicrobials approved for industrial or agricultural purposes but suspected of having a severe negative impact on AMR may be temporarily prohibited until further studies have been carried out; the development of non-antibiotic alternatives for animal health, including growth promoters, and in the development of new molecules for the development of new antibiotics.
Shaping the global agenda : the committee asked for a clear commitment on the part of the EU and the Member States to launching a crosscutting global strategy to combat AMR, covering policy areas such as international trade, development and agriculture. It noted that the use of antibiotics as growth promoters in food-producing animals has been banned in the EU since 2006, but that in countries outside the EU antibiotics can still be used in animal feed as growth promoters. It called on the Commission to include a clause in all free trade agreements stipulating that food imported from third countries must not have been produced using antibiotics as growth promoters, with a view to ensuring a level playing field for EU livestock farming and aquaculture and in order to mitigate AMR.
Lastly, the report called on the Commission to implement collaborative research programmes with third countries to reduce the overuse of antibiotics.
Documents
2018/06/20
EP - Vote in committee
2018/04/26
EP - Committee opinion
Documents
2018/03/07
EP - Amendments tabled in committee
Documents
2018/03/07
EP - Amendments tabled in committee
Documents
2018/02/22
EP - Committee opinion
Documents
2018/01/31
EP - Committee draft report
Documents
2017/12/14
EP - Committee referral announced in Parliament
2017/12/13
CZ_SENATE - Contribution
Documents
2017/10/26
EP - WIERINCK Lieve (ALDE) appointed as rapporteur in ITRE
2017/09/01
EP - KADENBACH Karin (S&D) appointed as rapporteur in ENVI
2017/06/29
EC - Non-legislative basic document published
Details
PURPOSE: to present a new European action plan to strengthen the fight against antimicrobial resistance (AMR).
BACKGROUND: according to the World Health Organization (WHO), AMR already presents a serious social and economic burden. It is estimated to be responsible for 25,000 deaths per year in the EU alone and 700,000 deaths per year globally , and might cause more deaths than cancer by 2050. In the EU alone it is estimated that AMR costs EUR 1.5 billion annually in healthcare costs and productivity losses
The EU was quick to recognise the importance of tackling AMR. The 2001 Community strategy against AMR was reinforced by the 2011 Commission action plan , notable for its One Health approach, addressing AMR in both humans and animals.
In view of the challenges of antimicrobial resistance at regional and global levels, the Union is at the forefront of combating this phenomenon. Since 1999, the Commission has invested more than EUR 1.3 billion in antimicrobial resistance research.
Responding to the request of the Member States set out in the Council conclusions of 17 June 2016, the new plan proposed by the Commission is based on the first action plan, implemented from 2011 to 2016. It is based on the recommendations of an independent external evaluation , as well as the views expressed by stakeholders in an open public consultation.
Based on the "One health" approach, the plan is motivated by the need for the Union to play a leading role in the fight against the phenomenon of antimicrobial resistance and to add value to the actions Member States.
Its overarching goal is to preserve the possibility of effective treatment of infections in humans and animals. It provides a framework for continued action to reduce the emergence and spread of AMR and to increase the development and availability of new effective antimicrobials inside and outside the EU.
CONTENT: the main objectives of this new plan revolve around the following three major pillars:
Pillar 1: making the EU a best practice region: as the evaluation of the 2011 action plan highlighted, this will require better evidence , better coordination and surveillance, and better control measures. EU action will help Member States in establishing, implementing and monitoring their own national One Health action plans on AMR, which they agreed to develop at the 2015 World Health Assembly.
The Commission's support will include:
providing evidence-based data, with the support of the Union agencies, on possible links between the consumption of antimicrobial agents and the occurrence of antimicrobial resistance in humans and food-producing animals; reviewing EU implementing legislation on monitoring AMR in zoonotic and commensal bacteria in farm animals and food; supporting Member States in raising awareness at national level through specific communication tools; co-funding projects and collaborate with WHO to assist EU Member States in the development and implementation of national action plans to combat antimicrobial resistance; developing training programmes for the competent authorities of Member States and health professionals; contributing to improving patient safety in hospitals by supporting good practices in infection prevention and control; developing EU guidelines for the prudent use of antimicrobials in human medicine; adopting a Union policy on pharmaceuticals in the environment.
Pillar 2: boosting research, development and innovation : the aims are to: (i) close current knowledge gaps, (ii) provide novel solutions and tools to prevent and treat infectious diseases, and (iii) improve diagnosis in order to control the spread of AMR. The Commission will work in partnership with Member States and industry, including small and medium-sized enterprises (SMEs), to tackle AMR in bacteria, viruses, fungi and parasites . Special attention will be given to the WHO priority list of pathogens as well as to tuberculosis, HIV/AIDS, malaria and neglected infectious diseases.
In particular, the Commission intends to support research with a view to:
improving early detection and better understanding the problems of antimicrobial resistance in the European health care, livestock and food production sectors; developing new drugs and treatments , including alternatives, as well as innovative anti-infective approaches and products for both humans and animals; developing new and effective preventive vaccines and new diagnostic tools in particular on-site tests in humans and animals; filling gaps in knowledge about the release of resistant microorganisms and antimicrobials into the environment.
Pillar 3: intensifying EU efforts worldwide to shape the global agenda : in an increasingly interconnected world, the Commission will:
strengthen the global presence of the Union by contributing to the normative work of multilateral organizations such as WHO, the World Animal Health Organisation (OIE), the Food and Agriculture Organisation (FAO) and international fora; promote standards and measures taken by the Union to combat antimicrobial resistance in the context of trade agreements; contribute to the reduction of antimicrobial resistance in least developed countries through programs to control infectious diseases.
Progress will be reviewed at regular intervals as part of the One Health network on antimicrobial resistance, to guide individual Member States in their actions and to decide on the appropriateness of further action at Union level.
Documents
Documents
- Commission response to text adopted in plenary: SP(2018)829
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament: T8-0354/2018
- Debate in Parliament: Debate in Parliament
- Committee report tabled for plenary: A8-0257/2018
- Committee opinion: PE615.417
- Amendments tabled in committee: PE619.155
- Amendments tabled in committee: PE619.156
- Committee opinion: PE613.604
- Committee draft report: PE613.613
- Contribution: COM(2017)0339
- Non-legislative basic document published: COM(2017)0339
- Non-legislative basic document published: EUR-Lex
- Committee draft report: PE613.613
- Committee opinion: PE613.604
- Amendments tabled in committee: PE619.155
- Amendments tabled in committee: PE619.156
- Committee opinion: PE615.417
- Commission response to text adopted in plenary: SP(2018)829
- Contribution: COM(2017)0339
Activities
- Karin KADENBACH
Plenary Speeches (2)
- Soledad CABEZÓN RUIZ
Plenary Speeches (1)
- Nicola CAPUTO
Plenary Speeches (1)
- Stefan ECK
Plenary Speeches (1)
- José Inácio FARIA
Plenary Speeches (1)
- Diane JAMES
Plenary Speeches (1)
- Urszula KRUPA
Plenary Speeches (1)
- Notis MARIAS
Plenary Speeches (1)
- Miroslav MIKOLÁŠIK
Plenary Speeches (1)
- Gilles PARGNEAUX
Plenary Speeches (1)
- Bolesław G. PIECHA
Plenary Speeches (1)
- Alojz PETERLE
Plenary Speeches (1)
- Marcus PRETZELL
Plenary Speeches (1)
- Daciana Octavia SÂRBU
Plenary Speeches (1)
- Ricardo SERRÃO SANTOS
Plenary Speeches (1)
- Renate SOMMER
Plenary Speeches (1)
- Lieve WIERINCK
Plenary Speeches (1)
- Anna ZÁBORSKÁ
Plenary Speeches (1)
Votes
A8-0257/2018 - Karin Kadenbach - Résolution 13/09/2018 12:28:29.000 #
2018/09/13 Outcome: +: 589, 0: 36, -: 12
Verts/ALE
GUE/NGL
NI| Amendments | Dossier |
| 701 |
2017/2254(INI)
2018/01/18
ITRE
96 amendments...
Amendment 1 #
Draft opinion Recital –A (new) -A. whereas the main cause of AMR is the excessive use of antibiotics and up to half of antibiotics used in humans are unnecessary and inappropriate, changing the way antibiotics are used is the single most important action needed to slow down the development of AMR;
Amendment 10 #
Draft opinion Recital A a (new) Aa. whereas the “Council conclusions on the next steps under a One Health approach to combat antimicrobial resistance”1a ask the Commission and the Member States to align strategic research agendas of existing EU R&D initiatives on new antibiotics, alternatives and diagnostics within a One Health Network on AMR; _________________ 1a http://www.consilium.europa.eu/en/press/ press-releases/2016/06/17/epsco- conclusions-antimicrobial-resistance/.
Amendment 11 #
Draft opinion Recital A a (new) Aa. whereas the political declaration endorsed by Heads of State at the United Nations General Assembly in New York in September 2016 signalled the world’s commitment to taking abroad, coordinated approach to address the root causes of antimicrobial resistance across multiple sectors;
Amendment 12 #
Draft opinion Recital A a (new) Aa. whereas phagetherapy is considered an effective complementary treatment to antibiotics that is showing positive results, is gaining growing scientific interest including by the pharmaceutical companies, but is however lacking sufficient research support at EU level;
Amendment 13 #
Draft opinion Recital A a (new) Aa. whereas in the past 40 years only one novel class of antibiotics has been developed, despite the spreading and progress of new resistant bacteria, moreover there is clear evidence of resistance to new agents within existing classes of antibiotics;
Amendment 14 #
Draft opinion Recital A a (new) Aa. whereas excessive and inappropriate use of antibiotics both in humans and animals is turning AMR into a massive threat for the future of humankind;
Amendment 15 #
Draft opinion Recital A b (new) Ab. whereas more than 100 companies have signed Davos declaration in January 2016, which calls for collective action to create a sustainable and predictable market for antibiotics, vaccines and diagnostics, that enhances conservation for new and existing treatments. It also calls for coordinated action to improve prevention of infections, hygiene, stewardship and conservation measures;
Amendment 16 #
Draft opinion Recital A b (new) Ab. whereas awareness of prevention and of the misuse of antimicrobials is still low across Member States; and whereas vaccination is an effective way of preventing infections that would need treatment with antibacterials and thereby reducing development of resistance;
Amendment 17 #
Draft opinion Recital A c (new) Ac. whereas nosocomial infections represents major threat in preserving and guarantee basic health care all over the world;
Amendment 18 #
Draft opinion Recital B a (new) Ba. whereas the Joint Programming Initiative on AMR has committed 52.95 million euro so far and further 14.4 million euro in its current call this year; whereas the IMI has seven projects on AMR, under the umbrella of the ND4BB programme, with a total budget of more than 600 million euro among European Commission funding contribution and pharma companies in kind contribution;
Amendment 19 #
Draft opinion Recital B a (new) Ba. whereas antimicrobial resistance can only be effectively addressed on global level and with engagement of private sector;
Amendment 2 #
Draft opinion Recital –A a (new) -Aa. whereas the consumption of antibiotics decreases as knowledge on the correct use of antibiotics increases;
Amendment 20 #
Draft opinion Recital B b (new) Bb. whereas science and research play a crucial role in the development of standards in the fight against AMR;
Amendment 21 #
Draft opinion Recital C C. whereas the different funding instruments under H2020
Amendment 22 #
Draft opinion Recital C C. whereas different funding instruments under H2020
Amendment 23 #
Draft opinion Recital C a (new) Ca. whereas the 50% of antibiotics prescriptions in humans are inadequate and the 25% of consumption in humans are not well administrated; whereas the 30% of hospitalised people use antibiotics and the most critical group of 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 24 #
Draft opinion Recital C a (new) Ca. whereas effective fight against AMR must be part of the broader international initiative with engaging as many international institutions, agencies and experts as possible;
Amendment 25 #
Draft opinion Recital C a (new) Ca. whereas the Commission has committed to invest more than EUR 200 million in AMR for the last 3 years of Horizon 2020;
Amendment 26 #
Draft opinion Recital C b (new) Cb. whereas bacteria are constantly evolving, the R&D and regulatory environments are complex, targeted infections are sometimes rare and the expected returns remain limited;
Amendment 27 #
Draft opinion Paragraph –1 (new) -1. Emphasises the need to decrease the usage of antibiotics in order to slowdown the further development of AMR;
Amendment 28 #
Draft opinion Paragraph 1 1. Emphasises the need to increase funding for R&I in epidemiology and immunology for AMR pathogens and healthcare-associated infections (HAI), in new antimicrobial drug resistance mechanisms, in developing new therapeutics 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 etiology of diseases are key areas for adequate use, and appropriate prescribing of antibiotic; calls therefore not only on new drugs but on new medical devices as well;
Amendment 29 #
Draft opinion Paragraph 1 1. Emphasises the need to increase funding for R&I in epidemiology and immunology for AMR pathogens and healthcare-associated infections (HAI) as well as to increase the funding of alternative treatments for humans and animals;
Amendment 3 #
Draft opinion Recital –A b (new) -Ab. whereas the spread of antimicrobials has contributed to the declining effectiveness of existing antimicrobials and more research is needed to develop alternative treatments;
Amendment 30 #
Draft opinion Paragraph 1 1. Emphasises the need to encourage the use of metagenomics methods and to increase funding for R&I in epidemiology and immunology for AMR pathogens and healthcare-associated infections (HAI);
Amendment 31 #
Draft opinion Paragraph 1 1. Emphasises the need to increase funding for R&I in epidemiology and different treatments in immunology for AMR pathogens and healthcare-associated infections (HAI);
Amendment 32 #
Draft opinion Paragraph 1 a (new) 1a. Emphasises that AMR has become one of the most important public health problems; nevertheless, insists that, although new antibiotics are needed, the origin of the problem lies above all in the their wrong usage, making it a priority to work in this area.
Amendment 33 #
Draft opinion Paragraph 1 a (new) 1a. Underlines the need of efficiency and coordination of research actions; welcomes therefore initiatives as the ERA- NET for establishing synergies between the Joint Programming Initiative on Antimicrobial Resistance Research and Horizon 2020;
Amendment 34 #
Draft opinion Paragraph 1 a (new) 1a. Stresses the need to provide investment and market incentives to promote research and development, to deliver new antimicrobials, vaccines, rapid diagnostics and alternative antimicrobial therapies;
Amendment 35 #
Draft opinion Paragraph 1 a (new) 1a. Calls to invest the EU funds in the context of Horizon 2020 and the next EU Framework Programme into research and development of alternative, albeit complementary, treatments such as phagotherapy;
Amendment 36 #
Draft opinion Paragraph 1 a (new) 1a. Urges the need to enable antimicrobial stewardship in order to improve evidence-based prescribing;
Amendment 37 #
Draft opinion Paragraph 1 a (new) 1a. Emphasises the need to increase funding for R&I regarding the rare diseases (orphan drugs);
Amendment 38 #
Draft opinion Paragraph 1 b (new) 1b. Highlights the fact that AMR rates vary widely among the Member States, for which reason it is crucial to coordinate national plans with specific targets and it is in this area of coordination and monitoring of national strategies that the Commission plays a key role;
Amendment 39 #
Draft opinion Paragraph 1 b (new) 1b. Emphasises the need to increase the funding for different instruments under H2020 so as to boost the research for improving our knowledge on detection, emergence and spread of AMR, prevention measures and effective infection control;
Amendment 4 #
Draft opinion Recital –A c (new) -Ac. whereas development and spread of antimicrobials in the environment is also a growing concern, requiring further research;
Amendment 40 #
Draft opinion Paragraph 1 b (new) 1b. Stresses the urgent need for in- depth research on the impact of presence antimicrobial substances on food crops and animal feed on the development of AMR, and on microbial community in soil;
Amendment 41 #
Draft opinion Paragraph 1 b (new) 1b. Inquires further cautious exploration of the possibilities of the use of off-label medicines as an alternative and as an additional treatment in AMR;
Amendment 42 #
Draft opinion Paragraph 1 c (new) 1c. Recalls that the most rapid and cost-effective strategy for addressing AMR is to ensure the adequate and rational use of the existing antimicrobials; highlights that all actors involved in the antimicrobials life-cycle chain shall take responsibility and cooperate towards this goal, including in particular the pharmaceutical, health and livestock industries; calls on the Commission to update and strengthen its guidelines and requirements for a prudent and rational use of antimicrobials in humans and animals;
Amendment 43 #
Draft opinion Paragraph 1 c (new) 1c. Recalls that health is a factor which affects productivity and competitiveness, as well as being one of the assets which is most valued by the public; stresses, therefore, that the establishment of national and European objectives to combat AMR should form part of the political and economic agenda of the EU.
Amendment 44 #
Draft opinion Paragraph 1 c (new) 1c. Underlines the need to invest in research and innovation dedicated to improvement of vaccination in order to support prevention;
Amendment 45 #
Draft opinion Paragraph 1 d (new) Amendment 46 #
Draft opinion Paragraph 1 e (new) 1e. Stresses that a third of prescriptions are issued in primary care, for which reason the prescription guidelines ought primarily to take account of this sector.
Amendment 47 #
Draft opinion Paragraph 2 2. Calls for incentivisation of the industry, such as the development of various push and pull incentives, to create new medicines and medical devices; believes that incentives are meaningful when they are sustainable over the long term, stimulate investment across the entire product development and life cycle, target key public health priorities, and support appropriate medicinal use;
Amendment 48 #
Draft opinion Paragraph 2 2. Calls for the development of various push and pull incentives to
Amendment 49 #
Draft opinion Paragraph 2 – subparagraph 1 (new) Considers that the pull models can exist of, but are not limited to the following models: - Transferable Market Exclusivities (TME):TMEs are a type of pull mechanisms that grants the new antibiotic market additional months of additional market exclusivity that can be transferred to another compound with a better commercial opportunity. This model could only work under the following conditions: defined length of the extension of exclusivity; distribute exclusivity amongst diverse compounds and each compound can only benefit from a TME once; sufficient notice: public disclosure of target compound for TME utilisation; - Lump sum Market Entry Reward (MER):increasing the revenue of new antimicrobials by directly through a cash payment upon market entry. These lump sum payment model could only work if the following conditions are met: scientifically sound criteria for entitlement to a reward, basing eligibility criteria on lists issued by the WHO or other relevant bodies; a pre-defined maximum number of rewards for priority pathogen and/or target product profile, defined by relevant organisations based on current and future medical need; - National or personal insurance model: as part of national or personal health insurance, citizens can ensure the access and development of new antimicrobials;
Amendment 5 #
Draft opinion Recital A A. whereas antimicrobial resistance (AMR)-related challenges will tremendously increase in the years ahead and inaction is projected to cause yearly millions of deaths globally, effective action is primarily reliant on better knowledge, prevention and reduced usage of antimicrobials, as well as on continued, cross-sectorial investments in research & innovation (R&I), so that better
Amendment 50 #
Draft opinion Paragraph 2 a (new) 2a. Recognises the differences between Member States in the practices and levels of use of antimicrobial medicines; calls for enhanced cooperation and sharing of best practices between Member States to develop evidence-based guidance to the use of antimicrobial medicines, to combat over usage of antimicrobial medicines and to foster research into AMR;
Amendment 51 #
Draft opinion Paragraph 2 a (new) 2a. Calls for the use of transferable market exclusivities as an option of meaningful incentives, which would allow the licensee of a new antimicrobial compound to extend to exclusivity of another compound, provided that they are applied with due consideration to the sustainability of healthcare systems;
Amendment 52 #
Draft opinion Paragraph 2 a (new) 2a. Calls on the Commission to ensure that substantial R&D efforts are made for increasing knowledge and properly assessing the role of the human, animal and manufacturing waste streams play in the development and spread of AMR, as foreseen in the One-Health action plan;
Amendment 53 #
Draft opinion Paragraph 2 a (new) 2a. Underlines the importance of identifying and addressing specific access, market sustainability and supply bottlenecks for existing antibiotics, diagnostics and vaccines, and the development of innovative financing and procurement mechanisms to resolve them;
Amendment 54 #
Draft opinion Paragraph 2 a (new) 2a. Highlights the fact that more than 20 new classes of antibiotics were developed until the 1960s and that only a few new types of antibiotics have reached the market since then;
Amendment 55 #
Draft opinion Paragraph 2 b (new) Amendment 56 #
Draft opinion Paragraph 2 c (new) 2c. Remembers that both institutions, the European Parliament and the Council have asked to review current incentives (i.e. orphan medicines regulation), due to the misused of them and the high final price; calls therefore on the Commission to analyse current R&D incentives models in order to design specific new ones for both, orphan medicines and antibiotics;
Amendment 57 #
Draft opinion Paragraph 2 d (new) 2d. Recalls on the need of transparency of real costs when there are public funds and on the delinkage of R&D costs from products prices and sales volumes; in this regard, highlights that guaranteeing affordability and access to quality antibiotics must be the final aim of R&D and incentives;
Amendment 58 #
Draft opinion Paragraph 2 e (new) 2e. Underlines the importance of working on a definition of R&D costs, where disbursements disconnected from the production chain and direct and indirect subsidies are subtracted;
Amendment 59 #
Draft opinion Paragraph 3 3. Expresses the urgent need to foster partnerships throughout the EU in order to enhance the exchange of best practices and improve knowledge on AMR; believes in the need of different models of collaboration through the impulse from the public sector and 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 Commission to launch a Public Network for the coordination of all public funded R&D projects in AMR, similar to the European Antimicrobial Resistance Surveillance Network (EARS-Net) for surveillance;
Amendment 6 #
Draft opinion Recital A A. whereas antimicrobial resistance (AMR)-related challenges will increase in the years ahead and effective action is reliant on two equally important strategies: on the one hand, continued, cross-sectoral investments in research & innovation (R&I) and, on the other hand, comprehensive strategies for timely tackling the excessive and inappropriate use of antimicrobials both in humans and animals, so that better tools, products and approaches can be developed following a One Health approach;
Amendment 60 #
Draft opinion Paragraph 3 3. Expresses the urgent need to foster partnerships throughout the EU in order to enhance the exchange of best practices and improve knowledge on AMR; encourages further pursuing private-public collaborations, such as the Innovative Medicine Initiative (IMI) programmes "New Drugs for Bad Bugs", COMBACTE, TRANSLOCATION, Drive AB or ENABLE, to harness the power of collaboration; furthermore encourages public-private partnerships aiming to foster innovation in the field;
Amendment 61 #
Draft opinion Paragraph 3 3. Emphasises that the EU should be at the forefront of the fight to address AMR, providing practical guidance to ensure sustainable effective action, in line with the Global Action Plan agreed by the World Health Assembly in 2015; expresses the urgent need to foster partnerships throughout the EU in order to enhance the exchange of best practices and improve knowledge on AMR;
Amendment 62 #
Draft opinion Paragraph 3 3. Expresses the urgent need to build a more holistic system for monitoring AMR issues, linking data on resistance, consumption and sales of antimicrobials to prescribing trends and other factors and to foster partnerships throughout the EU in order to enhance the exchange of best practices and improve knowledge on AMR;
Amendment 63 #
Draft opinion Paragraph 3 3. Expresses the urgent need to foster partnerships throughout the EU in order to enhance the exchange of best practices and improve knowledge on AMR; points out that particular attention must be paid to strengthening cooperation with the biotechnology research and industry sectors;
Amendment 64 #
Draft opinion Paragraph 3 3. Expresses the urgent need to foster partnerships throughout the EU in order to enhance the exchange of best practices in reducing the use of antibiotics and improve knowledge on AMR;
Amendment 65 #
Draft opinion Paragraph 3 3. Expresses the urgent need to foster partnerships
Amendment 66 #
Draft opinion Paragraph 3 a (new) 3a. Welcomes, regarding alternatives business models to promote R&D, initiatives as the Global Antibiotic Research and Development Partnership - GARDP initiative-, that explores alternative business models since the market has failed to sufficiently support the development of new antibiotics; remembers that the new business models need to be sustainable, needs-driven, evidence-based and guided by principles of affordability, effectiveness, efficiency and equity, in the benefit of patients;
Amendment 67 #
Draft opinion Paragraph 3 a (new) 3a. Underlines the importance of improvement and dedication of Public Private Partnerships and collaborations between industry, SMEs and public researchers to overcome the scientific challenges of creating new antibiotics, vaccines and diagnostics;
Amendment 68 #
Draft opinion Paragraph 3 a (new) 3a. Underlines that the EU should co- fund the Member States so as to help them establish and implement their national One-Health action plans against AMR;
Amendment 69 #
Draft opinion Paragraph 3 b (new) 3b. 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 to correct the antibiotics market; _________________ 4a http://www.wipo.int/publications/en/detail s.jsp?id=4197.
Amendment 7 #
Draft opinion Recital A A. whereas antimicrobial resistance (AMR)-related challenges will increase in the years ahead and effective action is reliant on continued, cross-sectoral investments in research & innovation (R&I), including investments in both the public and the private sector, so that better tools, products and approaches can be developed following a
Amendment 70 #
Draft opinion Paragraph 3 b (new) 3b. Urges the Commission to develop a mission on AMR in the future FP9 with a cross-sectorial and interdisciplinary approach;
Amendment 71 #
Draft opinion Paragraph 4 4.
Amendment 72 #
Draft opinion Paragraph 4 4. Stresses the need to improve data collection on prevalence, patterns and us/misuse on a systemic
Amendment 73 #
Draft opinion Paragraph 4 a (new) 4a. Highlights the need of an EU data collection system on the right use of all antibiotics. asks, therefore, for the development of protocols for prescription and use of antibiotics at a EU level recognising the responsibility of veterinarians and primary care doctors among others; asks also for the compulsory collection, at a national level, of all prescriptions of antibiotics, and its registration in a database of the using and prescription of antibiotics controlled and coordinated by experts in infections to spread the knowledge on the best use of them;
Amendment 74 #
Draft opinion Paragraph 4 a (new) 4a. Stresses the importance to improve awareness and understanding of AMR through effective sanitation, prevention measures, education and training, including EU public awareness campaigns and targeted training for health professionals, pharmacists, veterinaries and livestock breeders;
Amendment 75 #
Draft opinion Paragraph 4 a (new) 4a. Emphasises the need to analyse big data coming from different industry sectors;
Amendment 76 #
Draft opinion Paragraph 4 b (new) Amendment 77 #
Draft opinion Paragraph 4 b (new) 4b. Highlights the importance of environmental data in order to have an overview of all aspects affecting AMR;
Amendment 78 #
Draft opinion Paragraph 4 c (new) 4c. Underlines the lack of collection of data on the impact on health and socioeconomic burden of AMR on an EU- level and global scale;
Amendment 79 #
Draft opinion Paragraph 4 d (new) Amendment 8 #
Draft opinion Recital A A. whereas antimicrobial resistance (AMR)-related challenges will increase in the years ahead and effective action is reliant on continued, cross-sectoral investments in research & innovation (R&I), so that new antibiotics, better tools, products, devices and approaches can be developed following a One Health approach;
Amendment 80 #
Draft opinion Paragraph 5 5. Underlines the systemic nature of AMR; supports the Commission’s renewed commitment to promoting EU actions and leadership in fighting AMR, including internationally; highlights the need for enhanced collaboration, including in R&I, and the role of science diplomacy, in fostering synergies and optimising resource allocation
Amendment 81 #
Draft opinion Paragraph 5 a (new) Amendment 82 #
Draft opinion Paragraph 5 a (new) 5a. Underlines the significant part that the pharmaceutical industry shall play in this long-term effort on Combating AMR. Calls on the Commission to further explore the requirements of this contribution by the pharmaceutical industry, namely, interalia, by asking for AMR information in the labelling of antimicrobial products and involving the industry in the monitoring and evaluation of the average use of each commercialized product;
Amendment 83 #
Draft opinion Paragraph 5 a (new) 5a. Calls for the strengthening AMR surveillance national systems in developing countries in order to achieve the standardization of results;
Amendment 84 #
Draft opinion Paragraph 5 a (new) 5a. Notes the positive externalities/spillover effects of new antimicrobials on public health and science;
Amendment 85 #
Draft opinion Paragraph 5 a (new) 5a. Calls upon the G7, G20 and BRICS to act and work in close collaboration;
Amendment 86 #
5b. Urges to scale up and combine the numerous international programmes on EU and international level in order to facilitate and support the programmes of European Antimicrobial Resistance Network (EARS-Net), European Surveillance of Antimicrobial Consumption Network (ESAC-Net), Central Asian and Eastern European Surveillance of Antimicrobial Resistance (CAESAR), Joint Interagency Antimicrobial Consumption and Resistance Analysis (JIACRA), ), Institutional Programme for the Prevention and Control of Healthcare Associated Infections and Appropriate Use of Antimicrobials (PIRASAO), WHO Antimicrobial Medicines Consumption Network (AMC), European & Developing Countries Clinical Trials Partnership(EDCTP) and Poverty Related and Neglected Diseases (PRND)1a; _________________ 1a Damage done by Poverty Related and Neglected Diseases within the EU in the year 2015: almost 10.000 Deaths in the EU, 30.000 new HIV infections, mosquito transmitting dengue and chikungunya reported in many parts of Europe. Cf. Global Burden of Disease Results Tool, WHO and European Centre for Disease Prevention and Control.
Amendment 87 #
Draft opinion Paragraph 5 b (new) 5b. Welcomes the new WHO recommendations aim to help preserving the effectiveness of antibiotics that are important for human medicine by reducing their unnecessary use in animals3a; 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 WTO and associated or third countries, shaping a global policy in order to ban the use of antibiotics for fattering healthy animals; _________________ 3a http://www.who.int/foodsafety/areas_work /antimicrobial- resistance/cia_guidelines/en/.
Amendment 88 #
Draft opinion Paragraph 5 b (new) 5b. Recalls, as stated in the Commission Guidelines for the prudent use of antimicrobials in veterinary medicine, that the untargeted use of antimicrobials, its use in sub-therapeutic doses and its use for inappropriate periods of time severely increases the risk of development of AMR; stresses that the EU livestock industry must remain a global leader in phasing out the misuse of antimicrobials as a matter of routine, specially through feed and drinking water, and calls on the Commission for further strengthening the requirements for the use of antimicrobials in the livestock industry;
Amendment 89 #
Draft opinion Paragraph 5 b (new) 5b. Stresses the importance of closer cooperation between industry and the university and scientific establishment, so as to facilitate the creation of dedicated structures within universities and scientific centres for the purpose of fighting against AMR;
Amendment 9 #
Draft opinion Recital A A. whereas antimicrobial resistance (AMR)-related challenges will increase in the years ahead and effective action is reliant on continued, cross-sectoral investments in research & innovation (R&I), so that better tools, products and approaches, also on long term, can be developed following a One Health approach;
Amendment 90 #
Draft opinion Paragraph 5 b (new) 5b. Emphasises that, to be effective, incentives must meet or exceed the costs of developing new drugs over their life- cycle;
Amendment 91 #
Draft opinion Paragraph 5 c (new) 5c. Remembers that classic generation of antibiotics, based on a series of antibiotic modification techniques obtained from nature, is exhausted and that R&D investments to create a new generation should break the classical antibiotic paradigm; welcomes new techniques that have already being developed as for example, monoclonal antibodies that reduce the virulence of the bacteria, not killing it, but rendering it useless;
Amendment 92 #
Draft opinion Paragraph 5 c (new) 5c. Emphasises the potential role for European research bodies to take global leadership roles, for example in G7 and G20 fora;
Amendment 93 #
Draft opinion Paragraph 5 d (new) 5d. Underlines the importance of European initiatives as the ECDC programmes for infectious diseases as AIDS, TB or 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 priorisation 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 94 #
Draft opinion Paragraph 5 e (new) 5e. Brings up the report “Tackling drug-resistant infections globally: final report and recommendations"5a that estimates the cost of taking global action on AMR is up to 40 billion USD over a 10-year period what means what 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: about 0.05 percent; calls on the Commission to analyse these figures and the possibility to impose a tax on the industry for public health in the framework of its social responsibility; _________________ 5ahttps://amr- review.org/sites/default/files/160518_Fina l%20paper_with%20cover.pdf.
Amendment 95 #
Draft opinion Paragraph 5 f (new) 5f. 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"6a; _________________ 6ahttps://amr- review.org/sites/default/files/Industry_Dec laration_on_Combating_Antimicrobial_R esistance_UPDATED%20SIGNATORIES _MAY_2016.pdf.
Amendment 96 #
Draft opinion Paragraph 5 g (new) 5g. Alerts that the FAO estimates that the use of antibiotics and pesticides in agriculture will dramatically increase; calls on the Commission and member States to study new methods to eliminate the residues of pesticides and antibiotics on food; asks, as well, for the ban of the use of last-line antibiotics in the veterinary field;
source: 616.665
2018/03/07
ENVI
605 amendments...
Amendment 1 #
Motion for a resolution Citation 1 a (new) – having regard to the 2017 Guidelines of WHO on use of medically important antimicrobials in food- producing animals
Amendment 1 #
Draft opinion Paragraph -1 (new) -1. whereas the ‘One Health’ approach aims to maintain the effectiveness of treatments of infections in humans and animals alike, to stem the emergence and spread of antimicrobial resistance and to enhance the development and availability of new effective antimicrobials in the Union and the rest of the world;
Amendment 10 #
Motion for a resolution 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 10 #
Draft opinion Paragraph 1 a (new) 1a. Recalls the recent Guidelines1a of WHO on use of medically important antimicrobials in food-producing animals recommending farmers and the food industry stop using antibiotics routinely to promote growth and prevent disease in healthy animals to avoid the spread of antimicrobial resistance and proposing that the use of the last-resort antibiotics be banned altogether in animals; _________________ 1aWHO guidelines on use of medically important antimicrobials in food- producing animals, ISBN : 978-92-4- 155013-0
Amendment 100 #
Motion for a resolution Paragraph 2 2. Stresses that
Amendment 100 #
Draft opinion 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, pet keepers, and those involved in livestock farming;
Amendment 101 #
Motion for a resolution 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;
Amendment 101 #
Draft opinion 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
Amendment 102 #
Motion for a resolution Paragraph 2 2. Stresses that the
Amendment 102 #
Draft opinion Paragraph 7 a (new) 7a. Notes that the existence of correlation between found resistance to antibiotics in food-producing animals (e.g. broiler chickens) and a large proportion of bacterial infections in humans coming from handling, preparation and consumption of the meat of these animals is confirmed also by the EU Agencies1a ; _________________ 1aThe European Centre for Disease Prevention and Control, and the European Food Safety Authority https://ecdc.europa.eu/sites/portal/files/me dia/en/publications/Publications/antimicr obial-resistance-zoonotic-bacteria- humans-animals-food-EU-summary- report-2014.pdf
Amendment 103 #
Motion for a resolution 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 103 #
Draft opinion Paragraph 7 a (new) 7a. Underlines the importance of exchanges of best practices between Member States and the coordination of such exchanges by the Commission; welcomes in this context the reduction of the use of antibiotics in animal husbandry in the Netherlands by 64.4% in the period 2009-2016 and the stated ambition to further reduce it by 2020; calls on the Commission to recommend this example of public-private cooperation between public authorities, industries, scientists and veterinary surgeons in other parts of the Union as well;
Amendment 104 #
Motion for a resolution 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; highlights the success of national campaigns educating citizens on good antibiotic practices and praises the Member States who have taken the matter seriously; calls on the Commission to consider
Amendment 104 #
Draft opinion Paragraph 7 a (new) 7a. Calls for financial support to be provided to farmers’ organisations for the development of outreach, education and training programmes to raise awareness among farmers;
Amendment 105 #
Motion for a resolution 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; calls, in this connection, for an end to the routine prophylactic use of antibiotics in livestock 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 and to establish indictors to measure progress in the fight against AMR;
Amendment 105 #
Draft opinion Paragraph 7 a (new) 7a. Stresses that good animal welfare is key to good animal health and contributes to the reduction in use of antimicrobials which is essential for productive and sustainable farming;
Amendment 106 #
Motion for a resolution Paragraph 2 2. Stresses that the appropriate and
Amendment 106 #
Draft opinion Paragraph 7 a (new) 7a. Calls on the Member States and the European Union to encourage farmers to use immunoprophylaxis and to provide funding for this purpose;
Amendment 107 #
Motion for a resolution Paragraph 2 2. Stresses that the appropriate and prudent use of antimicrobials
Amendment 107 #
Draft opinion Paragraph 7 b (new) 7b. Draws attention to the latest research (February 2018) demonstrating that ESBLs (Extended Spectrum Beta Lactamases) are transferred to people only to a limited extent as a result of livestock farming or eating meat, mainly being transferred from person to person1 a; _________________ 1a Mevius, D. et al. (2018). Rapport ESBL-Attributieanalyse (ESBLAT). Op zoek naar de bronnen van antibioticaresistentie bij de mens. http://www.1health4food.nl/esblat
Amendment 108 #
Motion for a resolution 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 108 #
Draft opinion Paragraph 7 b (new) 7b. Stresses that research shows that interventions that restrict antibiotic use in food-producing animals are associated with a reduction in the presence of antibiotic-resistant bacteria in these animals1a; _________________ 1a http://www.thelancet.com/pdf/journals/lan plh/PIIS2542-5196(17)30141-9pdf
Amendment 109 #
Motion for a resolution 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 and to establish indictors to measure progress in the fight against AMR in all One Health domains at EU level;
Amendment 109 #
Draft opinion Paragraph 7 c (new) 7c. Calls on the Commission and Member States, in view of this recent research, to take care and maintain a sense of proportion in adopting measures, and to carefully assess and classify 'antibiotics' and 'antimicrobial resistance' in order to avoid unnecessarily restricting the availability of products to combat certain protozoa, such as coccidia, in European livestock farming;
Amendment 11 #
Motion for a resolution Citation 16 a (new) – having regard to the European Center for Disease Control Report 2016 on Antimicrobial resistance surveillance in Europe;
Amendment 11 #
Draft opinion 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 110 #
Motion for a resolution 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
Amendment 110 #
Draft opinion Paragraph 8 Amendment 111 #
Motion for a resolution 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
Amendment 111 #
Draft opinion Paragraph 8 Amendment 112 #
Motion for a resolution Paragraph 2 – subparagraph 1 (new) Insists that the use of antibiotics for preventive purposes in veterinary medicine should be strictly regulated, in accordance with the provisions of the new Regulation 2014/0257 (COD) on veterinary medicine;
Amendment 112 #
Draft opinion Paragraph 8 8. Underlines the need to change the business culture employed by veterinary medicine producers, which encourages the use and overuse of certain medicines in order to generate profits and which does not take the responsibility in ensuring the even handed availability of their veterinary medicinal products, especially alternatives to antimicrobials such as vaccines, in all the EU-market including small market areas;
Amendment 113 #
Motion for a resolution Paragraph 2 a (new) 2a. Calls on the Commission in cooperation with the Member States to launch an EU-wide information campaign for consumers and businesses on aquaculture in general and in particular the differences between the stringent and comprehensive standards on the European market and the standards applicable to imported products in third countries, with particular emphasis on the problems caused for food safety and public health by the introduction into the Union of particularly resistant micro- organisms and antimicrobial resistance (AMR);
Amendment 113 #
Draft opinion Paragraph 8 8. Underlines the need to change the business culture employed by some veterinary medicine producers,
Amendment 114 #
Motion for a resolution Paragraph 2 a (new) 2a. Draws the Commission's attention to the link between AMR and intensive farming, as many international health authorities have highlighted; as a result, expects the Commission to be consistent in its support measures for farmers under the CAP so that it does not guide them in the direction of farming models which are incompatible with the health challenges that we are facing, and to develop the accompanying measures needed to support best practices;
Amendment 114 #
Draft opinion Paragraph 8 8. Underlines the need to change the business culture employed by veterinary medicine producers, which encourages the use and overuse of certain medicines in order to generate profits; stresses also that the competences to prescribe and to sell antibiotics should be separated, and no veterinarian should do both;
Amendment 115 #
Motion for a resolution Paragraph 2 a (new) 2a. Expresses its concern at a practice in many Member States which is conducive to the development of AMR in that farmed animals are fed with antibiotics intended to prevent diseases; applauds the practice in some Member States in which antibiotics are given to farmed animals for the sole purpose of treating them when a veterinarian has found them to be sick;
Amendment 115 #
Draft opinion Paragraph 8 8. Underlines the need to change the business culture employed by veterinary medicine producers, which encourages the use and overuse of certain medicines in order to generate profits; supports new proposals regarding access to certain medicines and persons authorized to issue medical prescriptions;
Amendment 116 #
Motion for a resolution 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 116 #
Draft opinion Paragraph 8 8. Underlines the need to c
Amendment 117 #
Motion for a resolution Paragraph 2 a (new) 2a. Calls on the Commission and Member States to distinguish between livestock and pets particularly in the design of monitoring and assessment of the use of antimicrobials in veterinary medicine, as well as in the design of measures to address their use;
Amendment 117 #
Draft opinion Paragraph 8 8. Underlines the need to change the business culture employed by veterinary medicine producers, which encourages the use and overuse of certain medicines in order to generate profits, objectives that could be achieved through legislative measures;
Amendment 118 #
Motion for a resolution Paragraph 2 a (new) 2a. Regrets that the Commission's strategic approach, which is basically right, is all too often limited to declarations of intent and calls on the Commission to spell out its approach;
Amendment 118 #
Draft opinion Paragraph 8 8. Underlines the need to c
Amendment 119 #
Motion for a resolution 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 119 #
Draft opinion Paragraph 8 8. Underlines the need to
Amendment 12 #
Motion for a resolution Citation 16 a (new) – having regard to ECDC Report 2016 on Antimicrobial resistance surveillance in Europe;
Amendment 12 #
Draft opinion Paragraph 1 b (new) 1b. Underlines that routine use of some of the strongest antibiotics is now a common practice in farming in some developing countries;
Amendment 120 #
Motion for a resolution 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 standardized data;
Amendment 120 #
Draft opinion Paragraph 8 8. Underlines th
Amendment 121 #
Motion for a resolution Paragraph 2 a (new) 2a. Calls on the Commission to collect and report the volume of antibiotics produced by manufactures;
Amendment 121 #
Draft opinion 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 122 #
Motion for a resolution Paragraph 2 b (new) 2b. Stresses that there are considerable differences in the ways in which Member States handle and try to fight AMR; stresses that joint EU action against the increasing threat to human and animal health and the environment posed by antibiotic-resistant bacteria can only succeed if it is based on standardised data and calls on the Commission to develop and propose appropriate procedures and indicators to this end;
Amendment 122 #
Draft opinion Paragraph 8 a (new) 8a. Stresses the necessary synergy between the ‘One Health’ approach and data from existing environmental monitoring, in particular Watch List monitoring under the Water Framework Directive, in order to improve knowledge of the occurrence and spread of antimicrobials in the environment;
Amendment 123 #
Motion for a resolution Paragraph 2 b (new) 2b. Stresses the need for a time frame embedding the European One Health Action Plan; calls on the Commission and the Member States to include measurable and time-bound objectives and targets in the European One Health Action Plan and in national action plans to enable benchmarking;
Amendment 123 #
Draft opinion Paragraph 8 a (new) 8a. Stresses that particularly in rural areas it is challenging to respond to livestock health issues in good time and that it therefore has proven irreplaceable to allow veterinarians to directly supply antibiotics;
Amendment 124 #
Motion for a resolution 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 124 #
Draft opinion Paragraph 8 a (new) 8a. Highlights the need to consider addressing the illegal sale of antimicrobials and increase awareness of the implications of this issue for public health;
Amendment 125 #
Motion for a resolution 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 125 #
Draft opinion Paragraph 8 a (new) 8a. Stresses the need for the independence of veterinary practitioners, and others who prescribe, from incentives to push certain drugs;
Amendment 126 #
Motion for a resolution 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 126 #
8b. Considers it essential to develop regulatory or private measures in order to support the efforts of European farmers to combat antimicrobial resistance and to prevent such efforts from becoming a competitive disadvantage for them;
Amendment 127 #
Motion for a resolution Paragraph 2 d (new) 2d. Calls on the Commission to consider including antibiotics use reduction in food producing animals as an objective under the Common Agricultural Policy (CAP), and ensuring effective ways of using the resources distributed under the CAP to contribute to national actions plans;
Amendment 127 #
Draft opinion Paragraph 9 9. Notes that the use of antibiotics as growth promoters in food-producing animals has been banned in the EU since 2006; calls on the Commission for public health reasons strictly to enforce this ban as a conditionality to all food imports from third countries through Free Trade Agreements; calls also for this prohibition to be extended and transposed to the whole body of international law that may concern the use of antibiotics in animals (within the Codex Alimentarius, the WHO, the OIE, the FAO ...);
Amendment 128 #
Motion for a resolution 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 128 #
Draft opinion Paragraph 9 9. Notes that the use of antibiotics as growth promoters in food-producing animals has been banned in the EU since 2006; calls on the Commission to enforce this ban as a conditionality to all food imports from third countries through Free Trade Agreements; calls on the Commission to provide for a legal framework imposing penalties for non- compliance with the ban on the use of antibiotics as growth promoters.
Amendment 129 #
Motion for a resolution 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 129 #
Draft opinion Paragraph 9 9. Notes that the use of antibiotics as growth promoters in food-producing animals has been banned in the EU since 2006;
Amendment 13 #
Motion for a resolution Citation 16 a (new) – having regard to the ECDC report 2016 on AMR surveillance in Europe,
Amendment 13 #
Draft opinion Paragraph 1 c (new) Amendment 130 #
Motion for a resolution Paragraph 2 e (new) 2e. Calls on the Commission to conduct and publish amid-term evaluation and ex-post evaluation of the One Health Action Plan and to involve all relevant stakeholders in the evaluation procedure;
Amendment 130 #
Draft opinion Paragraph 9 9. Notes that the use of antibiotics as growth promoters in food-producing animals has been banned in the EU since 2006; calls on the Commission to enforce
Amendment 131 #
Motion for a resolution 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 131 #
Draft opinion Paragraph 9 9. Notes that the use of antibiotics as growth promoters in food-producing animals has been banned in the EU since 2006; calls on the Commission to enforce this ban as a conditionality to all food imports from third countries, including through Free Trade Agreements;
Amendment 132 #
Motion for a resolution Paragraph 3 3.
Amendment 132 #
Draft opinion Paragraph 9 9.
Amendment 133 #
Motion for a resolution 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 133 #
Draft opinion Paragraph 9 9. Notes that the use of antibiotics as growth promoters in food-producing animals has been banned in the EU since 2006; calls on the Commission to enforce this ban as an ex ante conditionality to all food imports from third countries through Free Trade Agreements;
Amendment 134 #
Motion for a resolution Paragraph 3 3. Calls on the Commission and the Member States to align surveillance, monitoring and reporting of AMR patterns and pathogens
Amendment 134 #
Draft opinion Paragraph 9 9. Notes that the use of antibiotics as growth promoters in food-producing animals has been banned in the EU since 2006; calls on the Commission to enforce this ban as a conditionality to all food imports from third countries
Amendment 135 #
Motion for a resolution 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 135 #
Draft opinion Paragraph 9 9. Notes that the use of antibiotics as growth promoters in food-producing animals has been banned in the EU since 2006; calls on the Commission to enforce this ban as a conditionality to all food imports from third countries
Amendment 136 #
Motion for a resolution Paragraph 3 3. Calls on the Commission and the Member States to align surveillance, monitoring and reporting of AMR patterns and pathogens; calls on the Commission to encourage the Member States to introduce and carry out monitoring of the national surveillance and AMR targets, and to support them in those tasks;
Amendment 136 #
Draft opinion Paragraph 9 a (new) 9a. Calls on the Commission to promote high standards of animal welfare and food production in trade agreements in order to ensure a level playing field between EU producers and third country producers; further calls on the Commission to encourage partners to align their AMR objectives and adopt best practice solutions used in the EU on their territories;
Amendment 137 #
Motion for a resolution 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 137 #
Draft opinion Paragraph 9 a (new) 9a. Stipulates that in any future trade deal with the post-Brexit UK this issue must be addressed and made conditional that any further advancements in the EU action tackling AMR be followed up by the UK in order to protect consumers and workers both in the EU and the UK;
Amendment 138 #
Motion for a resolution 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) 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 139 #
Motion for a resolution Paragraph 3 3. Calls on the Commission and the Member States to align surveillance, monitoring and reporting of AMR patterns and pathogens by establishing indicators that measure and compare progress in the fight against AMR and to encourage the evaluation of the standardized data;
Amendment 139 #
Draft opinion Paragraph 9 b (new) 9b. Calls for a halt to free trade negotiations with Mercosur countries, where the use of antibiotics as growth promoters is expected to double from 2010 to 2030;
Amendment 14 #
Motion for a resolution 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 14 #
Draft opinion 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 monitor the results that have been achieved; Stresses that Member States' Action Plans must address animal husbandry comprehensively to fulfil the targets of the One Health approach;
Amendment 140 #
Motion for a resolution 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 and the Member States to set ambitious targets in their respective Action Plans;
Amendment 140 #
10. Stresses that awareness of this issue should be raised at the highest political level, involving every head of state and every relevant UN organisation with a view to achieving compromises and ambitious results; Emphasises that international cooperation involving sharing information, knowledge and best practices in tackling AMR is crucial in the context of the one-
Amendment 141 #
Motion for a resolution Paragraph 3 3. Calls on the Commission and the Member States to align surveillance, monitoring and reporting of AMR patterns
Amendment 141 #
Draft opinion 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-
Amendment 142 #
Motion for a resolution Paragraph 3 3. Calls on the Commission and the Member States to align surveillance, monitoring and reporting of the use of specific antibiotics in the EU and of AMR patterns and pathogens;
Amendment 142 #
10. Stresses 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) Amendment 143 #
Draft opinion Paragraph 10 b (new) 10b. Notes that globally, antibiotic resistant genes are found in the environment - in soils, water and sediments; highlights that wastewater treatment plants are a leading source for antibiotic resistant genes in the environment, with antibiotics discharged for households, hospitals and industry; calls for the systematic monitoring of antibiotics and antibiotic resistant genes in wastewater treatment plants and more investment into filtering systems;
Amendment 144 #
Motion for a resolution Paragraph 3 a (new) 3a. Stresses that the geographical differentiation of antimicrobial resistance levels differ significantly within the EU; Takes note that the consumption of antibacterial for systemic use in DDD per 1000 habitants and per day differentiate from 36.3 in Greece to 10.4 in the Netherlands; Regrets that some Member States have yet to inform on their national consumption, such as the Czech Republic, and Liechtenstein; Emphasizes the seriousness of this issue and the need for a legal framework at Union level to further harmonise efforts in combatting AMR;
Amendment 144 #
10a. Stresses that the livestock farming sector should focus on disease prevention through good hygiene, housing and animal husbandry and on strict biosecurity measures, rather than the prophylactic use of antimicrobials;
Amendment 145 #
Motion for a resolution Paragraph 3 a (new) 3a. Stresses the need for a time frame embedding the European One Health Action Plan; calls on the Commission and the Member States to include measurable, time-bound objectives in both the European One Health Action Plan and in national action plans to enable benchmarking;
Amendment 145 #
Draft opinion Paragraph 10 a (new) 10a. Welcomes the setting up of the AMR One Health Network which aims to facilitate cross border exchange of good practices between Member States' human and veterinary health sectors, enabling the sharing of innovative ideas and stepping up national efforts to tackle AMR;
Amendment 146 #
Motion for a resolution Paragraph 3 b (new) 3b. Calls on the Commission to coordinate and monitor national strategies to enable sharing of best practices between Member States;
Amendment 146 #
Draft opinion Paragraph 10 a (new) 10a. Stresses that, because of the great significance of antibiotics in veterinary and human medicine in fighting illnesses and viruses in humans and animals, there is a need for a factual, science-based debate both in politics and in the media;
Amendment 147 #
Motion for a resolution Paragraph 3 c (new) 3c. 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 147 #
Draft opinion 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 148 #
Motion for a resolution Paragraph 4 4. Calls on the Commission to develop standardised surveys for collecting data on HAIs and to examine the risks to large human and animal populations during epidemics and pandemics;
Amendment 148 #
Draft opinion Paragraph 10 a (new) 10a. Stresses the need to include reciprocity clauses in Free Trade Agreements between the EU and third countries with regard to EU regulatory requirements on animal health, animal welfare and food safety;
Amendment 149 #
Motion for a resolution Paragraph 4 4. Calls on the
Amendment 149 #
Draft opinion Paragraph 10 a (new) 10a. Calls for comprehensive checks to be carried out on producers of antibiotics so that withdrawal periods are adapted to reality, in order to ensure that no antibiotics are present in food products;
Amendment 15 #
Motion for a resolution Recital A A. whereas the excessive and inappropriate use of antibiotics, or substances that can potentiate the undesirable effects of antibiotics on human and animal health and in livestock farms, and poor
Amendment 15 #
Draft opinion 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
Amendment 150 #
Motion for a resolution Paragraph 4 4. Calls on the Commission to develop standardised surveys for collecting specific data on HAIs;
Amendment 150 #
Draft opinion Paragraph 10 a (new) 10a. Calls for initiatives to encourage organic (bio) food consumption and equally effective measures to make them more affordable by bringing prices down;
Amendment 151 #
Motion for a resolution Paragraph 4 a (new) 4a. Highlights that better sharing of local, regional and national information and data on emerging issues in human and animal health together with the use of early warning systems can assist Member States in adopting appropriate containment measures to limit the spread of resistant organisms;
Amendment 151 #
Draft opinion Paragraph 10 b (new) 10b. Stresses that high-density farming may imply that antibiotics are improperly and routinely fed to livestock and poultry on farms to promote faster growth and are also widely used for prophylaxis purposes, to prevent disease spreading owing to the cramped, confined and stressful conditions in which the animals are kept and which inhibit their immune systems, and to compensate for the unsanitary conditions in which they are raised;
Amendment 152 #
Motion for a resolution Paragraph 4 a (new) 4a. Calls on the Commission to explore the possibility of expanding the development and use of natural antibiotics;
Amendment 152 #
Draft opinion 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 153 #
Motion for a resolution Paragraph 5 Amendment 153 #
Draft opinion Paragraph 10 b (new) 10b. Calls for the promotion and enhancement of, and the transition to, a mode of production based on agroecology;
Amendment 154 #
Motion for a resolution Paragraph 5 5. Urges the
Amendment 154 #
Draft opinion 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 155 #
Motion for a resolution Paragraph 5 5. Urges the Commission to expand the role and funding of
Amendment 156 #
Motion for a resolution 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 157 #
Motion for a resolution Paragraph 5 5. Urges the Commission to expand the role and funding of the ECDC in the fight against AMR, infection prevention and education of the public and medical and veterinary personnel;
Amendment 158 #
Motion for a resolution 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 159 #
Motion for a resolution Paragraph 5 5. Urges the Commission to expand the role and funding of the ECDC in the fight against AMR and HAI;
Amendment 16 #
Motion for a resolution Recital A A. whereas the excessive and inappropriate use of antibiotics, particularly in livestock farming (antibiotics used for prophylaxis and as antibiotic growth activators) and poor infection control practices have progressively rendered antimicrobial resistance (AMR) a massive threat to humankind;
Amendment 16 #
Draft opinion Paragraph 2 2. Calls on the Commission and the Member States to take an ambitious approach, taking into account the significant differences in antimicrobial resistance between regions, to ensuring that the targets set out in their respective Action Plans are fully and effectively achieved, and to strictly monitor the results that have been achieved;
Amendment 160 #
Motion for a resolution Paragraph 5 5. Urges the Commission to expand the role and funding of the ECDC in the fight against AMR and HAI;
Amendment 161 #
Motion for a resolution 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 162 #
Motion for a resolution Paragraph 5 a (new) 5a. Urges the Commission and Member States to submit regular and accurate reports on the number of confirmed cases of AMR in humans, as well as correct and up-to-date AMR mortality statistics;
Amendment 163 #
Motion for a resolution 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) 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 165 #
Motion for a resolution Paragraph 6 6. Emphasises that infection prevention, biosecurity measures 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; stresses the need for mandatory reporting to public health authorities of all patients who are found to be infected or identified as carriers of highly resistant bacteria; stresses the need for guidelines on isolation of hospitalised carriers and the creation of a multidisciplinary professional taskforce reporting directly to the Ministry of Health;
Amendment 166 #
Motion for a resolution Paragraph 6 6. Emphasises that infection prevention, biosecurity measures 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; stresses that prevention, when it comes to human health, must also consist of preventing as much as possible the use of antimicrobials to cure minor illnesses and must work for an end to the prescription of those medicines for viral illnesses;
Amendment 167 #
Motion for a resolution Paragraph 6 6. Emphasises that
Amendment 168 #
6. Emphasises that prevention is better than cure; infection prevention, biosecurity measures 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 169 #
Motion for a resolution 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 17 #
Motion for a resolution Recital A A. whereas the excessive and in
Amendment 17 #
Draft opinion Paragraph 2 2. Calls on the Commission and the Member States to take an ambitious approach to ensuring that the
Amendment 170 #
Motion for a resolution 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 171 #
Motion for a resolution 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 173 #
Motion for a resolution Paragraph 6 a (new) 6a. Calls on the Commission, ECDC, and Member States to encourage the use of single-use handtowels in hygiene- sensitive locations, such as healthcare institutions, food processing facilities, and nurseries.
Amendment 174 #
Motion for a resolution Paragraph 6 a (new) 6a. Encourages the focus on compliance to infection control guidelines, integrating targets for infection rate reductions, supporting good practice to help address patient safety in the hospital environment;
Amendment 175 #
Motion for a resolution Paragraph 6 a (new) 6a. Stresses the need for maximum prevention in hospitals, which are hotbeds for contamination by antibiotics-resistant microorganisms;
Amendment 176 #
Motion for a resolution 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) 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) 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 179 #
Motion for a resolution 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 responsible 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; stresses that preventive measures, including hygiene, should be scaled up to reduce the amount of antibiotics currently required to treat infections and for medical procedures; stresses that awareness on the perils of self-medication and over-prescription should be a core component of a preventive strategy, and de-prescription by healthcare professionals a possible solution;
Amendment 18 #
Motion for a resolution Recital A A. whereas the excessive and inappropriate use of antibiotics for humans and animals and poor infection control practices have progressively rendered antimicrobial resistance (AMR) a massive threat to humankind;
Amendment 18 #
Draft opinion 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 in a coordinated manner across the EU to ensure their effectiveness, and to strictly monitor the results that have been achieved;
Amendment 180 #
Motion for a resolution 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
Amendment 181 #
Motion for a resolution 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 and to use instruments relating to early diagnosis and treatment with new and existing medicines and other admissible treatment methods and practices permitted in the EU, thereby saving millions of lives of people and animals throughout the EU; underlines the importance of promoting ‘health literacy’, since it is crucial that patients understand healthcare information and are able to follow treatment instructions accurately;
Amendment 182 #
Motion for a resolution 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, with regard not only to consumption but also to waste management; underlines the importance of promoting ‘health literacy’, since it is crucial that patients understand healthcare information and are able to follow treatment instructions accurately;
Amendment 183 #
Motion for a resolution Paragraph 7 7. Calls on the Commission and the Member States to develop public health messages to raise public awareness on the cause and effect of Antimicrobial Resistance (AMR) and in doing so, to 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;
Amendment 184 #
Motion for a resolution 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, particularly prophylactic management; underlines the importance of promoting ‘health literacy’, since it is crucial that patients understand healthcare information and are able to follow treatment instructions accurately;
Amendment 185 #
Motion for a resolution Paragraph 7 7. Calls on the
Amendment 186 #
Calls on the European Commission to set up a specific EU Priority Pathogen List taking account the WHO list, which could be the basis for supporting the status of priority antibiotics and would provide a real added-value by directing R&D investments to the greatest threats;
Amendment 187 #
Motion for a resolution Paragraph 7 a (new) 7a. Calls on the Commission and Member States to develop training programmes for healthcare professionals around the latest research developments and best practice measures for preventing and tackling the spread of AMR; considers such training should be both embedded in the training of new healthcare professionals, as well as via a system of continued professional development;
Amendment 188 #
Motion for a resolution Paragraph 7 a (new) 7a. Highlights that preventive measures, including hygiene, should be scaled up to reduce the amount of antibiotics currently required to treat infections and medical procedures; notes that awareness on the perils of self- medication and overprescription should be a core component of this preventive strategy, and deprescription by health care professionals a possible solution;
Amendment 189 #
Motion for a resolution 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 19 #
Motion for a resolution Recital A A. whereas the excessive and inappropriate use of antibiotics and poor infection control practices have progressively rendered antimicrobial resistance (AMR) a massive threat to
Amendment 19 #
Draft opinion 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 monitor the results that have been achieved in order to arrive at reliable conclusions;
Amendment 190 #
Motion for a resolution Paragraph 7 a (new) 7a. Calls on the Commission and Member States to develop strategies to support patients' adherence to and compliance with antibiotic and other appropriate treatments as prescribed by medical professionals;
Amendment 191 #
Motion for a resolution Paragraph 8 8.
Amendment 192 #
Motion for a resolution Paragraph 8 8. Urges the Commission and Member States to create harmonised quality standards
Amendment 193 #
Motion for a resolution Paragraph 8 8. Urges the Commission and Member States to create harmonised quality standards
Amendment 194 #
Motion for a resolution Paragraph 8 8. Urges the Commission and Member States to create harmonised quality standards in EU-wide curricula and proper stewardship for health professionals in relation to prescribing, dosage, use and disposal of antimicrobials; recalls the important role that veterinary practitioners play in prescribing and supplying antibiotics to their farmer clients in rural areas; highlights the expertise that veterinary practitioners have, which contributes to raising awareness about AMR;
Amendment 195 #
Motion for a resolution Paragraph 8 8. Urges the Commission and Member States to create harmonised quality standards in EU-wide curricula and proper stewardship for health professionals in relation to prescribing, dosage, use and disposal of antimicrobials and to use instruments relating to early diagnosis and treatment with new and existing medicines and other admissible treatment methods and practices permitted in the EU, thereby saving millions of lives of people and animals throughout the EU; calls on the Commission and the Member States to inform the public of the consequences of drug resistance;
Amendment 196 #
Motion for a resolution Paragraph 8 8. Urges the Commission and Member States to create harmonised quality standards in EU-wide curricula and proper stewardship for health professionals in relation to prescribing, dosage, use and disposal of antimicrobials
Amendment 197 #
Motion for a resolution Paragraph 8 8. Urges the Commission and Member States to create harmonised quality standards in EU-wide curricula and proper stewardship for health professionals in relation to prescribing, dosage, use and disposal of antimicrobials, and to ensure the establishment and deployment of multidisciplinary antibiotic stewardship teams in hospital settings;
Amendment 198 #
Motion for a resolution Paragraph 8 8.
Amendment 199 #
Motion for a resolution 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 2 #
Motion for a resolution Citation 1 b (new) – having regard to the report of Replies of Federation of Veterinarians of Europe to EFSA/EMA on Antimicrobial use in food-producing animals 1a _________________ 1aFederation of Veterinarians in Europe, 2016: Antimicrobial use in food- producing animals, replies to questions of EFSA/EMA
Amendment 2 #
Draft opinion Paragraph -1 a (new) -1a. whereas antimicrobial resistance poses a cross-border health threat, but the AMR situation varies greatly from one Member State to another; whereas the Commission must therefore identify and act on areas of high European added value within the scope of the powers of the Member States which are responsible for determining their health policies;
Amendment 20 #
Motion for a resolution Recital A A. whereas the
Amendment 20 #
Draft opinion Paragraph 2 2. Calls on the Commission and the Member States to take an ambitious and leading approach to ensuring that the targets set out in their respective Action Plans are fully and effectively achieved, and to strictly monitor the results that have been achieved;
Amendment 200 #
Motion for a resolution Paragraph 8 a (new) 8a. Highlights the need for the development of protocols for prescription and use of antibiotics at a EU level; asks also for the compulsory collection, at a national level, of all prescriptions of antibiotics;
Amendment 201 #
Motion for a resolution Paragraph 8 a (new) 8a. Encourages the Member States to improve initial and continuous training for prescribing doctors and veterinarians;
Amendment 202 #
Motion for a resolution Paragraph 8 b (new) 8b. Stresses that giving out antimicrobial treatments strictly for the length of treatments only could reduce public healthcare costs and prevent overconsumption of antibiotics, particularly self-medication;
Amendment 203 #
Motion for a resolution 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
Amendment 204 #
Motion for a resolution 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
Amendment 205 #
Motion for a resolution 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
Amendment 206 #
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 these decisions; notes that the use of various immunosuppression methods and early prevention of infections and drug- resistant diseases is undervalued in the human and animal health protection system;
Amendment 207 #
Motion for a resolution Paragraph 9 9. Is aware that health professionals often need to make quick decisions on therapeutic indication for antibiotic treatment; notes that continued participation in training around latest research developments and best practice measures for preventing and tackling the spread of AMR, as well as rapid diagnostic tests can help to support these decisions;
Amendment 208 #
Motion for a resolution 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 these decisions; deplores, at the same time, that rapid diagnostic tests are still very rarely used;
Amendment 209 #
Motion for a resolution 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 these decisions and calls for incentive systems to be put in place to promote their use;
Amendment 21 #
Motion for a resolution 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 21 #
Draft opinion Paragraph 2 2. Calls on the Commission and the Member States to take an ambitious approach
Amendment 210 #
Motion for a resolution 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 incentives for the industry to develop effective and efficient testing methods, a
Amendment 211 #
Motion for a resolution 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
Amendment 212 #
Motion for a resolution Paragraph 10 10. Is aware that the cost of rapid diagnostic tools (RDT) may exceed the price of antibiotics; calls on the
Amendment 213 #
Motion for a resolution 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
Amendment 214 #
Motion for a resolution 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 215 #
Motion for a resolution Paragraph 10 10. Is aware that the cost of rapid diagnostic tools (RDT) may exceed the price of antibiotics; calls on the Commission and the Member States to propose incentives for the industry to develop effective and efficient testing methods and to develop the use of rapid diagnostic tools; calls on health insurance carriers to cover the extra cost arising from the use of RDT, given the long-term benefits of preventing the unnecessary use of antimicrobials;
Amendment 216 #
Motion for a resolution 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, given the long-term benefits of preventing the unnecessary use of antimicrobials, and the subsequent major cost savings for the health insurance industry;
Amendment 217 #
Motion for a resolution 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 218 #
Motion for a resolution Paragraph 10 – subparagraph 1 (new) Notes that the recently adopted EU indicators helping Member States to monitor their progress in combating AMR only focus on antibiotic consumption but do not reflect appropriateness of use; calls on the ECDC to amend the EU indicators accordingly;
Amendment 219 #
Motion for a resolution Paragraph 10 a (new) 10a. Calls on the Member States to ban the use of antibiotics in animal husbandry in all cases other than by prescription for disease;
Amendment 22 #
Motion for a resolution Recital A a (new) Aa. whereas the existence of correlation between found resistance to antibiotics in food-producing animals(e.g. broiler chickens) and a large proportion of bacterial infections in humans coming from handling, preparation and consumption of the meat of these animals is confirmed also by the EU Agencies 1a _________________ 1aEFSA, ECDC; 2016: The European Union Summary report on antimicrobial resistance in zoonotic and indicator bacteria from human, animal and food in 2014
Amendment 22 #
Draft opinion Paragraph 2 a (new) Amendment 220 #
Motion for a resolution Paragraph 11 Amendment 221 #
Motion for a resolution Paragraph 11 Amendment 222 #
Motion for a resolution Paragraph 11 Amendment 223 #
Motion for a resolution Paragraph 11 Amendment 224 #
Motion for a resolution Paragraph 11 11. Calls on the Commission and the Member States to
Amendment 225 #
Motion for a resolution Paragraph 11 11. Calls on the Commission and the Member States to
Amendment 226 #
Motion for a resolution Paragraph 11 11. Calls on the Commission and the Member States to restrict or stop the sale of antibiotics by those
Amendment 227 #
Motion for a resolution Paragraph 11 11. Calls on
Amendment 228 #
Motion for a resolution Paragraph 11 11.
Amendment 229 #
Motion for a resolution Paragraph 11 11. Calls on the Commission and the Member States to restrict
Amendment 23 #
Motion for a resolution Recital A a (new) Aa. whereas antibiotics continue to be used in animal husbandry as compensation for poor hygiene and disease prevention rather than in cases of need by prescription, contributing to the emergence of antimicrobial-resistant bacteria in animals which can be transmitted to humans;
Amendment 23 #
Draft opinion Paragraph 2 a (new) 2a. Stresses that farmers are aware of their particular responsibility for animal protection, animal health and food safety and ensure the proper use of antibiotics, which are necessary to keep animals healthy and treat sick animals as quickly as possible;
Amendment 230 #
Motion for a resolution Paragraph 11 11. Calls on the Commission and the Member States to re
Amendment 231 #
Motion for a resolution Paragraph 11 11. Calls on the
Amendment 232 #
Motion for a resolution 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 over-prescribe them;
Amendment 233 #
Motion for a resolution Paragraph 11 11. Calls on the Commission and the Member States to
Amendment 234 #
Motion for a resolution 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 235 #
Motion for a resolution Paragraph 11 11. Calls on the Commission and the Member States to broadly restrict or stop the sale of antibiotics by those doctors or veterinarians who prescribe them;
Amendment 236 #
Motion for a resolution 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 in a manner which is irresponsible or not in accordance with medical principles;
Amendment 237 #
Motion for a resolution 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; Whereas certain advanced and broad spectrum antibiotics should only be allowed for usage within in patient care;
Amendment 238 #
Motion for a resolution 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 also prescribe them, and to remove incentives for doctors and veterinarians to prescribe antibiotics;
Amendment 239 #
Motion for a resolution 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 24 #
Motion for a resolution Recital A a (new) Amendment 24 #
Draft opinion Paragraph 2 a (new) 2a. Stresses that antimicrobial resistance is a multifactorial problem and calls on the Commission and on Member States to foster cooperation between veterinarians, agricultural sector stakeholders and other health professional in the fight against antimicrobial resistance;
Amendment 240 #
Motion for a resolution Paragraph 11 a (new) 11a. Recognises the positive role of veterinary medicines in improving animal welfare; stresses, at the same time, other ways in which animal welfare and animal health can be promoted in practice, such as with regard to their housing, taking into account the impact on cost and a level playing field;
Amendment 241 #
Motion for a resolution Paragraph 11 a (new) 11 a. Calls on Member States to ensure greater levels of adherence to and compliance with antibiotic treatments as prescribed by medical professionals and greater understanding amongst patients of the importance of responsible use of antibiotics and the risks of increasing antimicrobial resistance;
Amendment 242 #
Motion for a resolution 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) 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) 11a. Calls on the Member States to prohibit the sale of antibiotics without a doctor's or veterinarian's prescription;
Amendment 245 #
Motion for a resolution Paragraph 11 a (new) 11 a. Points out that there are still Member States where antibiotics are available without a prescription;
Amendment 246 #
Motion for a resolution 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 247 #
Motion for a resolution 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 248 #
Motion for a resolution Paragraph 11 b (new) 11 b. Notes that some Member States have legally defined professionally qualified animal medicines advisors authorised to prescribe certain veterinary medicines by the relevant authorities; underlines that national action plans on antimicrobial resistance should not prohibit these persons, when necessary, from prescribing and supplying certain veterinary medicines, given the vital role these persons can play in isolated rural communities;
Amendment 249 #
Motion for a resolution Paragraph 11 b (new) 11 b. Calls for a prescription requirement for antibiotics within the European Union;
Amendment 25 #
Motion for a resolution Recital A a (new) Aa. whereas prudent antibiotic use and infection prevention and control targeting all healthcare sectors are the cornerstones for effective intervention to prevent the selection and transmission of antibiotic- resistant bacteria;
Amendment 25 #
Draft opinion Paragraph 2 b (new) 2b. Underlines that, taking into account the scientific advice of EFSA and other relevant Union agencies, one of the targets set out in all Member States' Action Plans should be to reserve Critically Important Antimicrobials, as identified by the WHO, exclusively for human use;
Amendment 250 #
Motion for a resolution 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 251 #
Motion for a resolution Paragraph 12 12. Highlights the value of vaccines in combating AMR; recommends integration of targets for
Amendment 252 #
Motion for a resolution Paragraph 12 12. Highlights the value of vaccines in combating AMR; recommends integration of targets for
Amendment 253 #
Motion for a resolution Paragraph 12 12. Highlights the value of vaccines in combating AMR; recommends integration of targets for
Amendment 254 #
Motion for a resolution Paragraph 12 12.
Amendment 255 #
Motion for a resolution Paragraph 12 12. Highlights the value of vaccines in combating AMR; highlights further the need to fully inform and reassure the public on the safety of those vaccines through industry-independent studies, given that the lower the uptake of vaccines, the greater the risk of the spread of that disease; recommends integration of targets for life-long vaccination as a key element of national action plans on AMR;
Amendment 256 #
Motion for a resolution 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; recommends that effective communication campaigns be set up, targeting the general public, in order to highlight the importance of vaccination and combat popular beliefs that may prompt some people to refuse vaccination;
Amendment 257 #
Motion for a resolution Paragraph 12 12. Highlights the value of vaccines and other methods of immunosuppression in combating AMR; recommends integration of targets for life-long vaccination as a key element of national action plans on AMR;
Amendment 258 #
Motion for a resolution Paragraph 12 12. Highlights the value of vaccines, probiotics and prebiotics in combating AMR; recommends integration of targets for life-long vaccination as a key element of national action plans on AMR;
Amendment 259 #
Motion for a resolution Paragraph 12 12. Highlights the value of some vaccines in combating AMR; recommends integration of targets for life-long vaccination as a key element of national action plans on AMR;
Amendment 26 #
Motion for a resolution Recital A a (new) Amendment 26 #
Draft opinion Paragraph 2 a (new) 2a. Calls for better enforcement of EU legislation on surveillance of AMR in food-producing animals and on the use of veterinary medicinal products and medicated feeding stuffs;
Amendment 260 #
Motion for a resolution Paragraph 12 a (new) 12a. Stresses that the European One Health Action Plan against Antimicrobial Resistance (AMR) observes that immunisation by means of vaccination is a cost-effective health intervention in efforts to combat AMR1 a1 a and that, in the Action Plan, the Commission announces incentives to promote the use of diagnostics, antimicrobial alternatives and vaccines2 a2 a, but that relatively higher costs of diagnosis, antimicrobial alternatives and vaccination as compared with conventional antibiotics are an obstacle to raising the vaccination rate, as the Action Plan aims to do3 a; underlines that various Member States already regard vaccination as an important policy measure both to prevent outbreaks of animal diseases across borders and to restrict further risks of contagion for the European agricultural market and have introduced it; _________________ 1a European Commission (29 June 2017), A European One Health Action Plan against Antimicrobial Resistance (AMR), p. 10. 2a Ibid., p. 12. 3a Ibid., p. 15.
Amendment 261 #
Motion for a resolution 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 262 #
Motion for a resolution Paragraph 12 a (new) 12 a. Calls Member States to strengthen efforts to prevent and control infections that can lead to sepsis; calls Member States to include in their national AMR action plans targeted measures to improve the prevention, early identification and diagnosis and clinical management of sepsis;
Amendment 263 #
Motion for a resolution 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 264 #
Motion for a resolution Paragraph 12 a (new) 12 a. 12a (new) Calls for the routine prophylactic use of antimicrobials in groups of farm animals to be phased out other than in genuinely exceptional circumstances;
Amendment 265 #
Motion for a resolution Paragraph 12 a (new) 12a. Stresses also how dangerous late forms of some diseases are where vaccination has been unsupervised;
Amendment 266 #
Motion for a resolution Paragraph 12 b (new) 12b. Calls on the Member States to take further steps to raise the vaccination rate in human and veterinary health care and thus tackle diseases and antibiotic resistance cost-effectively; calls on the Commission and Member States — including in the context of the reform of the Common Agricultural Policy — to bring about more synergies and, in accordance with the findings set out in its One Health Action Plan against antimicrobial resistance (AMR), to provide effective financial incentives and support for livestock farmers who can demonstrate that they have significantly reduced the use of antibiotics and achieved a high vaccination rate of their animals or livestock;
Amendment 267 #
Motion for a resolution Paragraph 12 b (new) 12 b. 12 b (new) Calls for the routine metaphylacticuse of antimicrobials in groups of farm animals to be phased out; recognises that metaphylaxis may be necessary to prevent the spread of disease in a one-off case but stresses that routine metaphylaxis must be replaced by disease prevention through improved husbandry, housing and hygiene;
Amendment 268 #
Motion for a resolution Paragraph 13 13. Highlights that the pollution of the environment by human and veterinary antibiotic residues is an emerging problem and encourages further research into the relative impact of this pollution on AMR; calls therefore for the necessary synergy between the ‘One Health’ approach and existing environmental monitoring data, in particular watch list monitoring under the Water Framework Directive, in order to improve knowledge of the occurrence and spread of antimicrobials in the environment;
Amendment 269 #
Motion for a resolution Paragraph 13 13. Highlights that the pollution of the environment by human and veterinary antibiotic residues is an emerging problem and encourages further research into the relative impact of this pollution on AMR that requires coherent policy measures to avoid the spreading of AMR between ecosystems, animals and people; believes that further research into transmission dynamics and the relative impact of this pollution on AMR is required;
Amendment 27 #
Motion for a resolution Recital A a (new) Aa. whereas excessive use of antiseptics depletes healthy bacteria populations, the first defence against antibiotic-resistant bacteria;
Amendment 27 #
Draft opinion Paragraph 2 a (new) 2a. Calls on the Commission and Member States to distinguish between livestock and pets, particularly in the design of monitoring and assessment of the use of antimicrobials and in the design of measures to address their use;
Amendment 270 #
Motion for a resolution Paragraph 13 13. Highlights that the pollution of the environment by human
Amendment 271 #
Motion for a resolution Paragraph 13 13. Highlights that the pollution of the environment by human and veterinary antibiotic residues is an emerging problem
Amendment 272 #
Motion for a resolution Paragraph 13 13. Highlights the fact that the pollution of the environment by
Amendment 273 #
Motion for a resolution Paragraph 13 13. Highlights th
Amendment 274 #
Motion for a resolution Paragraph 13 13. Highlights that the pollution of the environment by human and
Amendment 275 #
Motion for a resolution Paragraph 13 a (new) Amendment 276 #
Motion for a resolution Paragraph 13 a (new) 13 a. Calls on the Commission to appropriately effectively address emissions of pharmaceuticals into the environment and the emergence of AMR in its strategic approach to pharmaceuticals in the environment and to come up with a legislative proposal within this framework;
Amendment 277 #
Motion for a resolution Paragraph 13 a (new) 13a. Points out that natural water filtration may take nearly 70 years, making it impossible to measure the real environmental impact of mass consumption of antibiotics over the last few decades;
Amendment 278 #
Motion for a resolution 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) 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 28 #
Motion for a resolution Recital A a (new) Aa. whereas rapid diagnostic tools have the potential to limit antibiotic abuse and the risk of AMR developing;
Amendment 28 #
Draft opinion Paragraph 2 b (new) 2b. Notes that antibiotics can only be used in livestock farming following diagnosis and prescription by a veterinarian;
Amendment 280 #
Motion for a resolution Paragraph 13 a (new) 13 a. 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 281 #
Motion for a resolution Paragraph 13 a (new) 13a. Stresses the need for more information for consumers and patients on handling pharmaceutical residues and medical waste intelligently;
Amendment 282 #
Motion for a resolution 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) 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 284 #
Motion for a resolution Paragraph 13 b (new) 13b. Calls on the Member States to introduce incentive schemes for collecting unused antibiotics;
Amendment 285 #
Motion for a resolution 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 286 #
Motion for a resolution Paragraph 13 c (new) 13c. Is concerned at what is now the very intensive production of active substances for antibiotics in China and India, posing an unassessable risk of environmental pollution in very densely populated areas with high volumes of international comemrcial traffic;
Amendment 287 #
Motion for a resolution Paragraph 14 Amendment 288 #
Motion for a resolution Paragraph 14 14. Calls for environmental risk assessments as part of the marketing authorisation process for antimicrobials
Amendment 289 #
Motion for a resolution Paragraph 14 14. Calls for environmental risk assessments as part of the marketing authorisation process for antimicrobials; highlights that wastewater treatment plants are a leading source of antibiotic resistant genes in the environment;
Amendment 29 #
Motion for a resolution Recital A b (new) Ab. whereas several countries from which the EU imports animal products for consumption continue to use antibiotics in agriculture as a growth hormone; whereas until April of 2017, colistin, a pharmaceutical drug of last resort, was used in animal feeds in China and has since been introduced for use in human therapy; whereas the use of colistin in agriculture has been associated with the development of bacteria with a colistin- resistant gene known as mcr-11a; _________________ 1aWang, Yang, et al. “Prevalence, Risk Factors, Outcomes, and Molecular Epidemiology of Mcr-1 -Positive Enterobacteriaceae in Patients and Healthy Adults from China: an Epidemiological and Clinical Study.” The Lancet Infectious Diseases, vol. 17, no. 4, 2017, pp. 390–399., doi:10.1016/s1473- 3099(16)30527-8.
Amendment 29 #
Draft opinion Paragraph 2 c (new) 2c. Stresses that comprehensive monitoring of antibiotics in farming has been developed in conjunction with veterinarians which comprehensively documents the use of antibiotics and further improves their application; regrets that there is as yet no comparable system in human medicine;
Amendment 290 #
Motion for a resolution 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;
Amendment 291 #
Motion for a resolution 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;
Amendment 292 #
Motion for a resolution Paragraph 14 14. Calls for environmental risk assessments as part of the marketing authorisation process for antimicrobials on the basis of type or purpose;
Amendment 293 #
Motion for a resolution Paragraph 14 14. Calls for a review of the environmental risk assessments as part of the marketing authorisation process for antimicrobials;
Amendment 294 #
Motion for a resolution Paragraph 14 14. Calls for a stricter environmental risk assessments as part of the marketing authorisation process for antimicrobials;
Amendment 295 #
Motion for a resolution Paragraph 14 a (new) 14 a. 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 it can be spread on agricultural fields and to consider the risk posed by pharmaceuticals in the upcoming proposal on Water Reuse ;
Amendment 296 #
Motion for a resolution Paragraph 14 a (new) 14 a. Underlines that good farm management, bio-security and animal husbandry systems underpin the health and welfare of food-producing animals and when applied appropriately, minimise susceptibility to bacterial disease and minimise the need for antibiotic use in animals;
Amendment 297 #
Motion for a resolution 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) 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 299 #
Motion for a resolution Paragraph 14 a (new) 14 a. Calls on the Commission and the Member States to phase out the use of antimicrobial compounds or chemicals in non-clinical settings such as in everyday cleansing products and other consumer goods,
Amendment 3 #
Motion for a resolution 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 3 #
Draft opinion Paragraph -1 b (new) -1b. whereas the environment can contribute to the emergence and spread of antimicrobial resistance in animals, in particular because of human, animal and manufacturing waste streams;
Amendment 30 #
Motion for a resolution Recital A b (new) Amendment 30 #
Draft opinion Paragraph 3 3. Calls for legislative solutions that will assist farmers in reducing the use of antibiotics in livestock farming, with the aim of prudent and responsible use of antimicrobials; insists that such legislative solutions, including the on-going and inter-related work on the manufacture, placing on the market and use of medicated feed and repealing Council Directive 90/167/EEC and the proposal for a regulation of the European Parliament and of the Council on veterinary medicinal products, must address prophylactic and metaphylactic use of antibiotics;
Amendment 300 #
Motion for a resolution 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 301 #
Motion for a resolution Paragraph 14 a (new) 14 a. Calls for the strict abiding of Good Manufacturing Practices and green procurement rules regarding the production and distribution of pharmaceuticals in and into the EU;
Amendment 302 #
Motion for a resolution Paragraph 14 a (new) 14 a. Urges the Commission to formally include civil society in One Health discussions, for example by setting up and funding a dedicated stakeholder network;
Amendment 303 #
Motion for a resolution Paragraph 14 a (new) 14a. Points out in this connection that a thorough ex-ante assessment of the social costs of an ‘end of pipe’ approach is necessary;
Amendment 304 #
Motion for a resolution 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) 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 306 #
Motion for a resolution Paragraph 14 b (new) 14b. Calls on the Commission and Member States to encourage the development of sustainable medicinal products with a low impact on the environment and water and to encourage further innovation in the pharmaceutical industry in this regard;
Amendment 307 #
Motion for a resolution 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 308 #
Motion for a resolution 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 309 #
Motion for a resolution 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 31 #
Motion for a resolution 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 31 #
Draft opinion Paragraph 3 3. Calls for legislative solutions that will assist farmers in reducing the use of antibiotics in livestock farming, with the aim of prudent and responsible use of antimicrobials; insists that such legislative
Amendment 310 #
Motion for a resolution 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) 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) 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) 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 314 #
Motion for a resolution 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 315 #
Motion for a resolution Paragraph 14 e (new) 14 e. Underlines the importanceof a life cycle assessment approach, from production and prescription to the management of pharmaceutical waste; asks the Commission to address the disposal of antibiotics issue where alternatives to incineration should be explored, such as gasification;
Amendment 316 #
Motion for a resolution 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) 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) 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 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 ;
Amendment 32 #
Motion for a resolution Recital A b (new) Ab. whereas phytosanitary products used on a massive scale, such as glyphosate, have antimicrobial side- effects whose impact has not yet been fully evaluated;
Amendment 32 #
Draft opinion Paragraph 3 3. Calls for legislative solutions that will assist farmers in reducing the use of antibiotics in livestock farming, with the aim of prudent and responsible use of antimicrobials; insists that such legislative solutions must address prophylactic and metaphylactic use; in this regard notes the progress that has already been made in this direction through negotiations for a Regulation on Veterinary Medicinal Products and the Regulation on Medicated Feed: manufacture, placing on the market and use;
Amendment 320 #
Motion for a resolution 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) 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) 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 323 #
Motion for a resolution Paragraph 15 a (new) 15a. Urges the Commission to grant funding for research projects on new treatments, and regards the issue as sufficiently serious and strategic to warrant EFSI funding, in particular in connection with micropollutants with antimicrobial secondary effects;
Amendment 324 #
Motion for a resolution Paragraph 15 a (new) 15 a. Points out that science and research play a crucial role in the development of standards in the fight against AMR;
Amendment 325 #
Motion for a resolution Paragraph 15 b (new) 15b. Calls on the EU and the Member States to do their utmost to relocate research and development and the production of active substances for antibiotics within the EU, as a matter of urgency, where production outside the EU is quasi-monopolistic and poses health dependence risks for the Member States;
Amendment 326 #
Motion for a resolution Paragraph 15 b (new) 15 b. Points out the need to increase financial resources for R&I in epidemiology and immunology for AMR pathogens and healthcare-associated infections (HAI) as well as to increase financial resources for alternative treatments for humans and animals;
Amendment 327 #
Motion for a resolution Paragraph 16 Amendment 328 #
Motion for a resolution 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 329 #
Motion for a resolution Paragraph 16 a (new) 16 a. Notes recent research in the development of next-generation probiotics for concomitant use with antibiotic treatment in clinical settings, which has been shown to reduce health care- associated infections caused by highly antibiotic resistant bacteria3a; _________________ 3aPamer, Eric G. “Resurrecting the Intestinal Microbiota to Combat Antibiotic-Resistant Pathogens.” Science, vol. 352, no. 6285, 2016, pp. 535–538., doi:10.1126/science.aad9382.
Amendment 33 #
Motion for a resolution Recital A c (new) Ac. whereas alternative therapies, such as phage therapy, are available and are in development;
Amendment 33 #
Draft opinion Paragraph 3 3. Calls for
Amendment 330 #
Motion for a resolution Paragraph 16 a (new) 16 a. Notes that the research and development of novel approaches to the treatment and prevention of infections is equally important and can include using substances to strengthen the immune response to bacterial infection, such as pre and probiotics;
Amendment 331 #
Motion for a resolution Paragraph 16 a (new) 16a. Stresses the high expectations and efforts of start-ups working on phage therapy and calls for procedures for authorising the placing on the market of new technologies to be facilitated, with a view to adding to the current battery of treatments;
Amendment 332 #
Motion for a resolution Paragraph 16 b (new) 16b. Calls on European and national authorities to approach health authorities elsewhere in the world, including in Russia, which have long been using bacteriophage therapy in order to obtain feedback;
Amendment 333 #
Motion for a resolution Paragraph 17 Amendment 334 #
Motion for a resolution Paragraph 17 17. Encourages the European Medicines Agency (EMA) 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; calls on the EFSA and EMA to look immediately into the antimicrobial effects of glyphosate and other substances and their environmental and health implications;
Amendment 335 #
Motion for a resolution Paragraph 17 17. Encourages the European Medicines Agency (EMA) to review
Amendment 336 #
Motion for a resolution 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 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 338 #
Motion for a resolution Paragraph 17 – subparagraph 1 (new) Stresses that early dialogue between innovators and regulatory authorities should be encouraged in order to adapt the regulatory framework when necessary to prioritize and speed up the development of antimicrobial medicines and to allow faster access.
Amendment 339 #
Motion for a resolution 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 34 #
Motion for a resolution 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 34 #
Draft opinion Paragraph 3 3. Calls for legislative solutions that will assist farmers in reducing the use of antibiotics in livestock farming, with the aim of prudent and responsible use of antimicrobials; insists that such legislative solutions must carefully address prophylactic and metaphylactic use, considering that it sometimes may be required to address a subliminal infection in a herd before a full outbreak occurs;
Amendment 340 #
Motion for a resolution 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 341 #
Motion for a resolution 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 for further research on the link between exposure to commercial formulations of pesticides and developed antimicrobial resistance.
Amendment 342 #
Motion for a resolution 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, as well as the health associated infections (HAI);
Amendment 343 #
Motion for a resolution 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
Amendment 344 #
Motion for a resolution 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 345 #
Motion for a resolution 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 346 #
Motion for a resolution 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) 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 348 #
Motion for a resolution Paragraph 18 a (new) 18 a. Calls on the Commission to support research on hand hygiene and on the impact of different hand washing and hand drying methods on the transmission of potential pathogens.
Amendment 349 #
Motion for a resolution Paragraph 18 a (new) 18 a. Welcomes recent cross-border research projects into antimicrobial stewardship and the prevention of infection;
Amendment 35 #
Motion for a resolution Recital B B. whereas the
Amendment 35 #
Draft opinion Paragraph 3 3. Calls for
Amendment 350 #
Motion for a resolution 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 19. Calls on the Commission and the Member States to promote early and continuous dialogue with all stakeholders to
Amendment 352 #
Motion for a resolution Paragraph 19 19. Calls on the Commission and the Member States to promote early and continuous dialogue with all stakeholders to elaborate incentives for research and development (R&D) in the field of AMR; acknowledges that the
Amendment 353 #
Motion for a resolution Paragraph 19 19. Calls on the Commission and the Member States to promote early and continuous dialogue with all stakeholders to e
Amendment 354 #
Motion for a resolution 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 355 #
Motion for a resolution Paragraph 19 a (new) 19 a. Believes that research into fighting antimicrobial resistance is already taking place in many different places in the European Union without there being any adequate overview of the state of research in the EU; suggests, therefore, setting up a dedicated platform at EU level to enable research resources to be used more efficiently in the future;
Amendment 356 #
Motion for a resolution Paragraph 19 a (new) 19 a. Recalls the value of developing coalitions between academia and biopharmaceutical companies in terms of developing new antibiotics, rapid diagnostics and novel therapies;
Amendment 357 #
Motion for a resolution 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 21. Calls on the Commission and the Member States to
Amendment 359 #
Motion for a resolution Paragraph 21 21. Calls on the
Amendment 36 #
Motion for a resolution Recital B B. whereas the misuse of antibiotics is eroding their efficacy and leading to the spread of highly resistant
Amendment 36 #
Draft opinion Paragraph 3 3. Calls for legislative solutions that will assist farmers in reducing the use of antibiotics in livestock farming, with the aim of prudent and responsible use of antimicrobials; insists that such legislative solutions must address
Amendment 360 #
Motion for a resolution Paragraph 21 21. Calls on the Commission
Amendment 361 #
Motion for a resolution Paragraph 21 21. Calls on the
Amendment 362 #
Motion for a resolution 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 363 #
Motion for a resolution Paragraph 21 21. Calls on the Commission and the Member States to support the implementation of new economic models, pilot projects and incentives to boost the development of new diagnostics, antibiotics, alternatives and vaccines and improve conditions in livestock farming, thereby making it possible to reduce the use of antimicrobials in that field;
Amendment 364 #
Motion for a resolution Paragraph 21 21. Calls on the Commission and the Member States to support the implementation of new economic models, pilot projects and incentives to boost the development of new diagnostics, antibiotics, alternatives to using antimicrobials, medical devices, and vaccines;
Amendment 365 #
Motion for a resolution Paragraph 21 21. Calls on the Commission and the Member States to support the implementation of new economic models, pilot projects and incentives to boost the development of new diagnostics, antibiotics, alternatives to using antimicrobials, medical devices, and vaccines;
Amendment 366 #
Motion for a resolution Paragraph 21 21. Calls on the Commission and the Member States to support the implementation of new economic models, pilot projects and various push and pull incentives to boost the development of new diagnostics, antibiotics, alternatives and vaccines;
Amendment 367 #
Motion for a resolution 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 368 #
Motion for a resolution Paragraph 21 21. Calls on the Commission and the Member States to support the implementation of new economic models, pilot projects and incentives to boost the development of new therapies, diagnostics, antibiotics, alternatives and vaccines;
Amendment 369 #
Motion for a resolution Paragraph 21 a (new) 21 a. Calls on the Commission to assess the efficiency of current hygeine practices and santitation methods in hospitals and healthcare environments; asks the Commission to explore the use of probiotics and other sustainable hygenie techonologies as efficient sanitations approaches to prevent and reduce the number of HAIs attributed to AMR;
Amendment 37 #
Motion for a resolution Recital B B. whereas the misuse of antibiotics is eroding their efficacy and leading to the
Amendment 37 #
Draft opinion Paragraph 3 3. Calls for legislative solutions that will assist farmers in reducing the use of antibiotics in livestock farming, with the aim of prudent and responsible use of
Amendment 370 #
Motion for a resolution Paragraph 21 a (new) 21 a. Encourages the uptake of cost- effectiveness technologies that reduce the impact of health associated infections (HAIs) in hospitals and help preventing the spread of multi-resistant microorganisms;
Amendment 371 #
Motion for a resolution Paragraph 21 a (new) 21 a. Encouraging the uptake of cost- effectiveness technologies that reduce the impact of health associated infections (HAIs) in hospitals and help preventing the spread of multi-resistant microorganisms
Amendment 372 #
Motion for a resolution Paragraph 21 a (new) 21 a. calls on the Commission to ensure that in any situation in which it has invested EU funds, the possibility for excess private profit extraction is minimised;
Amendment 373 #
Motion for a resolution 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 374 #
Motion for a resolution Paragraph 22 22. Notes th
Amendment 375 #
Motion for a resolution Paragraph 22 22. Notes th
Amendment 376 #
Motion for a resolution Paragraph 22 22. Notes the hesitant approach of the industry to develop
Amendment 377 #
Motion for a resolution 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
Amendment 378 #
Motion for a resolution 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;
Amendment 379 #
Motion for a resolution Paragraph 22 22. Notes the
Amendment 38 #
Motion for a resolution 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 38 #
Draft opinion Paragraph 3 3. Calls for legislative solutions that will assist farmers in reducing the use of antibiotics in livestock farming, with the aim of
Amendment 380 #
Motion for a resolution Paragraph 22 22.
Amendment 381 #
Motion for a resolution 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; calls
Amendment 382 #
Motion for a resolution 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 383 #
Motion for a resolution Paragraph 23 Amendment 384 #
Motion for a resolution Paragraph 23 23. Calls on the Commission and Member States to develop new incentive models that delink payment from prescribing volume and are sustainable over the long-term, stimulate investment across the entire product development and life-cycle, target key public health priorities, and support appropriate medicinal use;
Amendment 385 #
Motion for a resolution Paragraph 23 23. Calls on the Commission and the Member States to
Amendment 386 #
Motion for a resolution Paragraph 23 23.
Amendment 387 #
Motion for a resolution 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 388 #
Motion for a resolution Paragraph 23 23. Calls on the Commission and Member States
Amendment 389 #
Motion for a resolution Paragraph 23 23. Calls on the Commission and Member States to develop new incentive models that delink payment from prescribing volume, , as excess prescription has been directly linked to a rise in AMR;
Amendment 39 #
Motion for a resolution 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 39 #
Draft opinion Paragraph 3 3. Calls for legislative solutions that will assist farmers in reducing the use of antibiotics in livestock farming, with the aim of prudent and responsible use of antimicrobials, so as to protect the health of animals and humans; insists that such legislative solutions must address prophylactic and metaphylactic use;
Amendment 390 #
Motion for a resolution Paragraph 23 23. Calls on the Commission and Member States to work together with the industry to develop new incentive models that delink payment from prescribing volume;
Amendment 391 #
Motion for a resolution Paragraph 23 23. Calls on the
Amendment 392 #
Motion for a resolution 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 393 #
Motion for a resolution Paragraph 23 a (new) 23 a. Underlines the importance of working on a definition of R&D costs, where disbursements disconnected from the production chain and direct and indirect subsidies are subtracted;
Amendment 394 #
Motion for a resolution Paragraph 23 a (new) 23 a. Calls for the use of transferable market exclusivities or market entry rewards to be considered as options for sustainable incentives;
Amendment 395 #
Motion for a resolution Paragraph 23 a (new) 23 a. Calls on the Commission to take the gloabl lead in advocating evidence- based best practice models for early diagnosis to tackle AMR;
Amendment 396 #
Motion for a resolution 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 397 #
Motion for a resolution 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; emphasises in this regard the importance of building international partnerships and coalitions to influence change at national, European and international level on the more efficient discovery and development of medicines, vaccines and diagnostics;
Amendment 398 #
Motion for a resolution 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 399 #
Motion for a resolution 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; underlines the existing challenge that routine use of some of the strongest antibiotics is now a common practice in farming in some of the developing countries.
Amendment 4 #
Motion for a resolution 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 4 #
Draft opinion Paragraph 1 1. Stresses that antimicrobial resistance (AMR) is a critical global health issue that requires proactive, coordinated action; points out that ongoing surveillance is essential to understand both the development and dissemination of AMR; 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; highlights that tackling AMR is a matter of global responsibility, requiring simultaneous action in human health, animal health and the environment;
Amendment 40 #
Motion for a resolution Recital B a (new) Ba. whereas the continued spreading of highly resistant bacteria could make it impossible in the future to provide for good healthcare with regard to invasive operations or well established treatments for some groups of patients requiring radiotherapy, chemotherapy or transplants;
Amendment 40 #
Draft opinion Paragraph 3 3. Calls for
Amendment 400 #
Motion for a resolution 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 European and global and intersectoral action and the development of a holistic approach to monitoring antimicrobial resistance issues;
Amendment 401 #
Motion for a resolution Paragraph 24 24. Recalls that owing to the complexity of the problem, its cross-border dimension, the severe consequences for human
Amendment 402 #
Motion for a resolution 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, as well as the high economic burden, AMR requires urgent and coordinated global and intersectoral action;
Amendment 403 #
Motion for a resolution 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 404 #
Motion for a resolution Paragraph 24 24. Recalls that owing to the complexity of the problem, its cross-border dimension, the severe consequences for environment, human and animal health and the high economic burden, AMR requires urgent and coordinated global and intersectoral action;
Amendment 405 #
Motion for a resolution Paragraph 24 24. Recalls that owing to the
Amendment 406 #
Motion for a resolution 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;
Amendment 407 #
Motion for a resolution 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 408 #
Motion for a resolution Paragraph 24 a (new) 24 a. Stipulates that in any future trade deal with the post-Brexit UK the AMR must be addressed and it is made conditional that any further advancements in the EU action tackling AMR be followed up by the UK in order to protect consumers and workers both in the EU and the UK
Amendment 409 #
Motion for a resolution 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 41 #
Motion for a resolution Recital B b (new) Amendment 41 #
Draft opinion Paragraph 3 3. Calls for legislative solutions that will assist farmers in
Amendment 410 #
Motion for a resolution 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 aligned;
Amendment 411 #
Motion for a resolution 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 412 #
Motion for a resolution Paragraph 25 a (new) 25 a. 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 26.
Amendment 414 #
Motion for a resolution 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 415 #
Motion for a resolution 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) and diseases connected with epidemics and pandemics; 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;
Amendment 416 #
Motion for a resolution 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, as a matter of urgency, to increase their support to research
Amendment 417 #
Motion for a resolution Paragraph 26 26. Notes that AMR is of serious concern in many poverty-related and neglected diseases (PRNDs) and diseases linked to migration, 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;
Amendment 418 #
Motion for a resolution 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 ensure that, should those new health tools be developed, prices of those new drugs are kept at a reasonable level;
Amendment 419 #
Motion for a resolution 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 42 #
Motion for a resolution Recital C C. whereas healthcare-associated infections (HAI) are often due 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 a
Amendment 42 #
Draft opinion Paragraph 3 3. Calls for legislative solutions that will
Amendment 420 #
Motion for a resolution Paragraph 26 a (new) 26a. Stresses that these diseases are back in Europe for two main reasons: the current budgetary policies, which are increasing levels of poverty, and migration policies; points out that the migrants who have already reached Europe and who are suffering from multidrug-resistant tuberculosis should be taken into care to limit the risk of contagion;
Amendment 421 #
Motion for a resolution 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 422 #
Motion for a resolution Paragraph 26 b (new) 26b. Stresses that a migration and development policy involving the treatment of sick people in their country of origin would be far more responsible than letting sick migrants enter the EU;
Amendment 423 #
Motion for a resolution 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 424 #
Motion for a resolution Paragraph 26 c (new) 26c. Deplores the fact that the tuberculosis vaccine was struck off the list of mandatory vaccines in the EU a very long time ago in favour of unnecessary vaccines, and that international anti- tuberculosis programmes have failed to achieve results;
Amendment 425 #
Motion for a resolution Paragraph 26 d (new) 6d. Expresses concern at the importation of hyper-hygienic habits that are promoting the spread of saprophytic bacteria that are themselves resistant to antibiotics;
Amendment 426 #
Motion for a resolution Paragraph 27 Amendment 427 #
Motion for a resolution Paragraph 27 27. Calls on the Commission to
Amendment 428 #
Motion for a resolution Paragraph 27 27. Calls on the Commission to advocate EU standards and measures for tackling AMR in trade agreements; notes that the use of antibiotics as growth promoters in food-producing animals has already been banned in the European Union since 2006; demands that the Commission impose that prohibition as a precondition for all foods imported from third countries under Free Trade Agreements with a view to ensuring a level playing field for European livestock farming and aquaculture and in order not to leave any loopholes in the implementation of the approach to antimicrobial resistance;
Amendment 429 #
Motion for a resolution Paragraph 27 27. Calls on the Commission to advocate EU standards and measures for tackling AMR in trade agreements; considers it important in this connection to observe high environmental and quality standards in the production of foodstuffs and the raw materials from which they are made; notes with concern that in countries outside Europe antibiotics are also used in animal feed as growth promoters;
Amendment 43 #
Motion for a resolution Recital C C. whereas healthcare-associated infections (HAI) are
Amendment 43 #
Draft opinion Paragraph 3 3. Calls for
Amendment 430 #
Motion for a resolution Paragraph 27 27. Calls on the Commission to advocate EU standards and measures for tackling AMR in trade agreements and to guarantee that our standards are being applied to meat imports from third countries;
Amendment 431 #
Motion for a resolution 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 432 #
Motion for a resolution Paragraph 27 a (new) 27a. Calls on the Commission to enforce the ban on the use of antibiotics as growth promoters in food-producing animals for all food imports from third countries; calls on the Commission also to ban all food imports from third countries where these imports come from animals treated with antibiotics or antibiotic groups that are reserved for the treatment of certain human infections in the European Union;
Amendment 433 #
Motion for a resolution Paragraph 27 a (new) 27a. Expresses indignation at the potential signing of trade agreements with countries that authorise the use of antibiotics as animal growth factors or which do not have a responsible policy for the control of antibiotic prescriptions, thus exposing Europeans, via imports, to the very dangers that this report is trying to limit;
Amendment 434 #
Motion for a resolution Paragraph 27 a (new) 27a. 27. Points out that the use of antibiotics as growth promoters in food- producing animals has been banned in the EU since 2006; calls on the Commission to apply this ban to all food imports from third countries;
Amendment 435 #
Motion for a resolution Paragraph 27 b (new) 27b. 27a. Points out that the Commission should specify which antibiotics or groups of antibiotics are to be reserved for the treatment of certain infections in humans; calls on the Commission also to ban all food imports from third countries where these imports come from animals treated with antibiotics or antibiotic groups that are reserved for the treatment of certain human infections in the European Union;
Amendment 436 #
Motion for a resolution Paragraph 28 28. Calls on the Commission and the Member States to strengthen measures to combat illegal practices related to the
Amendment 437 #
Motion for a resolution Paragraph 28 28. Calls on the Commission and the Member States to strengthen measures to combat illegal practices related to the
Amendment 438 #
Motion for a resolution Paragraph 28 28. Calls on the Commission and the Member States to strengthen measures to combat illegal practices related to the
Amendment 439 #
Motion for a resolution Paragraph 28 28. Calls on the Commission and the Member States to strengthen measures to combat illegal practices related to the
Amendment 44 #
Motion for a resolution Recital C C. whereas healthcare-associated infections (HAI) are often due to antibiotic-resistant bacteria and poor hygiene practices, especially in hospitals; 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 44 #
Draft opinion 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 440 #
Motion for a resolution 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) 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 442 #
Motion for a resolution Paragraph 28 a (new) 28a. Calls on the Commission and Member States to take stronger measures against the sale of large consignments of antimicrobials, in particular critical human antibiotics, at dumping prices;
Amendment 443 #
Motion for a resolution 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 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;
Amendment 445 #
Motion for a resolution 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 European scientific bodies, like ECDC, to take global stewardship roles;
Amendment 446 #
Motion for a resolution 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 European scientific bodies, like ECDC, to take global stewardship roles;
Amendment 447 #
Motion for a resolution 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; calls also for close cooperation and joint action by the United Nations, the G7 and the G20;
Amendment 448 #
Motion for a resolution Paragraph 29 29. Calls on the Commission
Amendment 449 #
Motion for a resolution Paragraph 29 a (new) 29 a. Calls on the Commission to advocate collaboration between the EU and international organisations, including WHO, FAO, and OIE;
Amendment 45 #
Motion for a resolution Recital C C. whereas healthcare-associated infections (HAI)
Amendment 45 #
Draft opinion Paragraph 3 a (new) 3a. Believes that, in order to facilitate responsible use of antimicrobials, there is an imperative need for rapid, reliable and efficacious veterinary diagnostics both to identify the cause of disease and to perform antibiotic sensitivity testing; is of the opinion that this would facilitate correct diagnosis, allow for a targeted use of antimicrobials, support using as little as possible critically important antimicrobials and, therefore, inhibit the development of antimicrobial resistance;
Amendment 450 #
Motion for a resolution Paragraph 29 a (new) 29 a. Calls on the Commission to advocate collaboration between the EU and international organisations, including WHO, FAO, and OIE;
Amendment 451 #
Motion for a resolution Paragraph 30 30. Instructs its President to forward this resolution to the Council, the Commission, the European Centre for Disease Prevention and Control, the European Medicines Agency, the European Chemicals Agency, the European Food Safety Authority, the European
Amendment 46 #
Motion for a resolution 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 46 #
Draft opinion Paragraph 3 a (new) 3a. Supports, as a minimum, the Council's response to the draft Codex Alimentarius Code of Practice to Minimise and Contain Antimicrobial Resistance, and its principles 18 and 19 on responsible and prudent use of antimicrobials;
Amendment 47 #
Motion for a resolution 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 47 #
Draft opinion Paragraph 3 b (new) 3b. Stresses that responsible and prudent prophylactic use of antimicrobials should be limited to exceptional cases. This use should not be systematic, nor routine, nor applied to compensate for poor hygiene or inadequate animal husbandry practices, and it should be prescribed by a veterinarian only for a limited duration to cover the period of risk. It should always be based on epidemiological and clinical knowledge, with documented justification. Prophylactic use of antibiotics should be limited to individual animals only. Prophylactic use should always represent a very small proportion of total therapeutic infectious disease-related use.
Amendment 48 #
Motion for a resolution Recital C a (new) Ca. whereas the preventive campaigns in certain Member States discouraging the systematic use of antibiotics in the treatment of mild infections have so far yielded mixed results and have not led to a significant reduction in the use of antibiotics, given that the behaviour of patients and prescribing physicians shows little sign of changing;
Amendment 48 #
Draft opinion Paragraph 3 b (new) 3b. Believes that the fight against antibiotic resistance should start on farms; is of the opinion that the EU should prohibit the purely preventive use of antibiotics, restrict collective treatment to very specific cases, prohibit the veterinary use of antibiotics that are critically important for human medicine and put an end to online sales of antibiotics, vaccines and psychotropic substances; takes the view that, thanks to these measures, the amounts of antibiotics found on consumers’ plates will be reduced;
Amendment 49 #
Motion for a resolution 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) 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 5 #
Motion for a resolution Citation 11 b (new) Amendment 5 #
Draft opinion 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 50 #
Motion for a resolution Recital C a (new) Ca. whereas the use of antibiotic compounds in non-clinical consumer products has been shown to increase the risk of generating drug-resistant bacteria strains2a; _________________ 2a http://ec.europa.eu/health/ph_risk/commit tees/04_scenihr/docs/scenihr_o_021.pdf
Amendment 50 #
Draft opinion Paragraph 3 c (new) 3c. Stresses that responsible and prudent metaphylactic use should not be systematic, nor routine, nor applied to compensate for poor hygiene or inadequate animal husbandry practices. The decision to administer antimicrobials metaphylactically should be based on a diagnosis and prescribed by a veterinarian, with documented justification; The decision should be based on epidemiological and clinical knowledge, an understanding of risk factors associated with the group, and in accordance with pre-established criteria for initiation of administration of antimicrobials. When considering preventative use in populations, it should be focused on subsets at highest risk. When antimicrobials are used for (non- routine) metaphylaxis, owners and keepers of food-producing animals shall ensure that they have a health plan specifying appropriate non-medical measures to reduce the need to resort to metaphylactic use in the future;
Amendment 51 #
Motion for a resolution Recital C a (new) Ca. whereas good hand hygiene, in the form of effective hand washing and hand drying, can contribute to preventing the transmission of infectious diseases and AMR;
Amendment 51 #
Draft opinion Paragraph 4 4. Calls for further research and
Amendment 52 #
Motion for a resolution 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 52 #
Draft opinion Paragraph 4 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; recalls that stress suppresses certain immune functions against disease, and that research shows that animals in less intensive farming models experience less stress, meaning their immune systems are less compromised as a result;
Amendment 53 #
Motion for a resolution Recital D 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 54 #
Motion for a resolution Recital D a (new) Da. whereas ECDC and EFSA have reconfirmed that antimicrobial resistance is one of the largest threats to public health;4a _________________ 4a http://onlinelibrary.wiley.com/doi/10.2903 /j.efsa.2018.5182/epdf
Amendment 54 #
Draft opinion Paragraph 4 4. Calls for increased investment to conduct further research and development into new antimicrobials and encourages alternatives, in particular cost-effective alternatives, to be investigated, including the development of more sustainable farming systems based on less intensive farming models;
Amendment 55 #
Motion for a resolution Recital D a (new) Da. whereas antimicrobial resistance is just as transmissible as the infections concerned;
Amendment 55 #
Draft opinion Paragraph 4 4. Calls for further research and development into new antimicrobials and encourages preventive solutions or alternatives to be investigated, including the development of new and effective preventive vaccines for animals and more sustainable farming systems based on less intensive farming models;
Amendment 56 #
Motion for a resolution Recital D a (new) Da. whereas drug-resistant TB is the leading cause of death from AMR;
Amendment 56 #
Draft opinion Paragraph 4 4. Calls for further research and development into new antimicrobials and encourages alternatives to be investigated
Amendment 57 #
Motion for a resolution Recital E E. whereas the World Bank in its abovementioned report has warned that by 2050, drug-resistant infections could cause global economic damage
Amendment 57 #
Draft opinion Paragraph 4 4. Calls for further research and development into new antimicrobials and encourages
Amendment 58 #
Motion for a resolution Recital E E. whereas the World Bank in its
Amendment 58 #
Draft opinion Paragraph 4 4. Calls for further research and development into new antimicrobials and encourages alternatives, such as vaccines, to be investigated, including the development of more sustainable
Amendment 59 #
Motion for a resolution Recital E a (new) Ea. whereas the objective of the ‘One Health’ approach is to keep treatments for human and animal infections effective, to stem the emergence and spread of antimicrobial resistance and to enhance the development and availability of new effective antimicrobials in the EU and the rest of the world;
Amendment 59 #
Draft opinion Paragraph 4 4. Calls for further research and development into new antimicrobials and encourages alternatives to be investigated, including the development of more sustainable farming systems
Amendment 6 #
Motion for a resolution 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 6 #
Draft opinion Paragraph 1 1. Stresses that antimicrobial resistance (AMR) is a critical global health issue that requires 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, food production and the environment, as it can serve as a reservoir of antibiotic- resistance genes;
Amendment 60 #
Motion for a resolution Recital E a (new) Amendment 60 #
Draft opinion Paragraph 4 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
Amendment 61 #
Motion for a resolution 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 61 #
Draft opinion Paragraph 4 a (new) 4a. Firmly believes that the most effective means of combatting AMR which is linked to the intensification of farming is the promotion of short supply chains in the food industry and the creation of local quality brands, these can bring benefits such as; Improved negotiating positions for farmers; These supply chains offer farmers greater power during negotiations, especially during those with retailers, Increased communication between producer and consumer; Short supply chains can lead to job creation, especially in rural areas, Reduced transportation costs; Short supply chains typically serve a local area, reducing the energy costs, transportation costs, and CO2 emissions, Increased transparency; It’s easier to make short supply chains with few or no intermediaries transparent than it is longer and more complex ones, Reduced risk; A short supply chain reduces the risk of damage, contamination, Increased quality; Doing business and transporting goods locally increases their overall quality by reducing the need for freezing and use of preservatives, Greater profits; Short supply chains offer farmers with greater profits while keeping the end-price more or less the same for consumers;
Amendment 62 #
Motion for a resolution Recital E a (new) Amendment 62 #
Draft opinion Paragraph 4 a (new) 4a. Calls for approaches to antimicrobials to take into account the need for a paradigm shift in farming; calls also for flanking measures to help the agricultural sectors manage the transition from an intensive ‘feedlots’- type model to a more extensive type of farming, based on space and grassland (in France, for example, each cow has an average of one hectare to feed and recycle its excrement);
Amendment 63 #
Motion for a resolution Recital E a (new) Ea. whereas lack of access to effective antibiotics in developing countries still cause more deaths than resistance; whereas AMR is a threat to the achievement of several of the Sustainable Development Goals outlined in Agenda 2030;
Amendment 63 #
Draft opinion Paragraph 4 a (new) 4a. Highlights that the spread of antimicrobials and consequent antimicrobial resistance in the environment is also a growing concern, requiring further research; Stresses in particular the urgent need for in-depth research on the impact of antimicrobial substances in food crops and animal feed on microbial communities in soil and aquatic ecosystems, as well as the disposal of slurry and wastewater;
Amendment 64 #
Motion for a resolution Recital E a (new) Ea. whereas a key pillar of any EU- wide strategy for AMR must be to ensure continued training of healthcare professionals in the latest developments in research and best practices regarding the prevention and spread of AMR,
Amendment 64 #
Draft opinion Paragraph 4 a (new) 4a. Believes that, in order to encourage research into new antimicrobials, incentives are needed, including longer periods of protection for technical documentation on new medicines, commercial protection of innovative active substances, and protection for significant investments in data generated to improve an existing antimicrobial product or to keep it on the market;
Amendment 65 #
Motion for a resolution Recital E a (new) Ea. whereas the World Health Assembly estimates that sepsis – as a death-leading syndromic response to most infectious diseases – causes approximately 6 million deaths worldwide every year, which are mostly preventable.
Amendment 65 #
Draft opinion Paragraph 4 a (new) 4a. Stresses, therefore, that the current innovation framework does not effectively encourage R&D into AMR and calls for the adjustment and harmonisation of the intellectual property regime at European level, in particular in order to better match protection with the period requested for the innovative medicine in question;
Amendment 66 #
Motion for a resolution 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 66 #
Draft opinion Paragraph 4 a (new) 4a. Calls for a reduction in the use of antibiotics, particularly last-line antibiotics, to be the objective not only in livestock farming but across the whole of veterinary and human medicine;
Amendment 67 #
Motion for a resolution Recital E a (new) Ea. whereas nature provides us with a plethora of powerful antibiotics, a source which could be harnessed to a far greater degree than is presently the case;
Amendment 67 #
Draft opinion Paragraph 4 a (new) 4a. Calls for further research on the link between exposure to commercial formulations of pesticides and developed antimicrobial resistance;
Amendment 68 #
Motion for a resolution 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 68 #
Draft opinion Paragraph 4 a (new) 4a. Highlights the role that farm advisory services can play in promoting sustainable farm management practices;
Amendment 69 #
Motion for a resolution Recital E b (new) Eb. whereas antimicrobial resistance is a cross-border threat to health, but the antimicrobial resistance situation varies greatly from one Member State to another; whereas, therefore, the Commission must identify and act in areas that bring high European added value, whilst respecting the powers of the Member States, which are responsible for determining their own health policies;
Amendment 69 #
Draft opinion Paragraph 4 b (new) 4b. Highlights that significant volumes of antibiotics are used either prophylactically amongst healthy animals, to stop the development of an infection within a flock or herd, or simply for growth promotion, to speed up the pace at which animals gain weight; notes that both uses are particularly prevalent in intensive agriculture, where animals are kept in confined conditions; considers it necessary to take measures to encourage extensive grazing or organic farming methods;
Amendment 7 #
Motion for a resolution 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 7 #
Draft opinion Paragraph 1 1. Stresses that antimicrobial resistance (AMR) is a critical global health issue that requires 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
Amendment 70 #
Motion for a resolution 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 70 #
Draft opinion Paragraph 4 b (new) 4b. Stresses the importance of effective environmental risk assessment in the approvals process for new and existing veterinary medicines with antimicrobial properties, particularly as concerns the end-points of antimicrobial substances in the wider environment;
Amendment 71 #
Motion for a resolution Recital E b (new) Amendment 71 #
Draft opinion Paragraph 4 b (new) 4b. Points out that in light of the reduced effectiveness of certain antibiotics, rapid diagnostic tests can assist health professionals to provide targeted and effective treatment options as a viable alternative to antibiotic use in humans;
Amendment 72 #
Motion for a resolution Recital E b (new) Eb. whereas patients should have access to healthcare and treatment options, including to complementary and alternative treatments and medicines, based on their own choice and preference;
Amendment 72 #
Draft opinion Paragraph 4 c (new) 4c. Believes that requirements to ensure that labelling makes reference to antibiotic use would improve consumer knowledge and help enable consumers to make a more informed choice; notes that having products labelled as "antibiotic- free" might also provide incentives for farmers to withhold antibiotic treatment when an animal might need it, for fear of the economic cost of not being able to sell the meat;
Amendment 73 #
Motion for a resolution Recital E c (new) Ec. whereas the retail sale of veterinary medicines, including antibiotics, is organised differently in each Member State and is governed by the national laws of each Member State, in line with the principle of subsidiarity; whereas there is no correlation between reduced veterinary antibiotic use and the separation between the professional who prescribes the antibiotic and the one who delivers it;
Amendment 73 #
Draft opinion Paragraph 4 c (new) 4c. Underlines the importance of a long term sustainable budget for research and development into both new antimicrobials and alternatives to antibiotics;
Amendment 74 #
Motion for a resolution Recital E c (new) Ec. whereas competition is an important factor in the overall balance of the pharmaceutical market and can lower costs, reduce expenditure on medicines and improve timely access for patients to affordable medicines, with higher quality standards being observed in the research and development process;
Amendment 74 #
Draft opinion Paragraph 4 c (new) 4c. Notes that some plant protection products also have antimicrobial properties, which may affect the spread of antimicrobial resistance;
Amendment 75 #
Motion for a resolution Recital E c (new) Amendment 75 #
Draft opinion Paragraph 5 5. Stresses that
Amendment 76 #
Motion for a resolution Recital E d (new) Ed. whereas the use of antibiotics for zootechnical purposes - as growth promoters, for example - is a misuse of these health products that is denounced by all the international health organisations, which recommend its prohibition in the fight against antimicrobial resistance; whereas the use of antibiotics as growth promoters in food-producing animals has been banned in the EU since 2006;
Amendment 76 #
Draft opinion 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
Amendment 77 #
Motion for a resolution Recital E d (new) Ed. whereas numerous diseases caused by microbes can be effectively combated not with antibiotics, leading to drug resistance, but with early diagnosis combined with new and existing medicines and other admissible treatment methods and practices permitted in the EU, thereby saving millions of lives of people and animals throughout the EU;
Amendment 77 #
Draft opinion Paragraph 5 5. Stresses that disease prevention must be the first step for legislation tackling AMR in agriculture, both to ensure a high standard of animal welfare and reduce the need to resort to antibiotics; believes that antibiotics should never be used as compensation for poor hygiene or inadequate animal husbandry but only in combination with other methods of protecting animal health;
Amendment 78 #
Motion for a resolution Recital E e (new) Ee. whereas the gap between growing resistance to antimicrobial agents and the development of new antimicrobial agents is widening; whereas drug-resistant diseases could cause 10 million deaths a year worldwide by 2050; whereas it is estimated that every year in the EU at least 25 000 people die of infections caused by resistant bacteria, at an annual cost of EUR 1.5 billion, while only one novel class of antibiotics has been developed in the past 40 years;
Amendment 78 #
Draft opinion Paragraph 5 5. Stresses that disease prevention must be the first step for
Amendment 79 #
Motion for a resolution Recital E e (new) Ee. whereas, if antibiotics reserved exclusively for human use are to be kept effective and the risks of antimicrobial resistance against these crucial antibiotics are to be minimised, the use of certain antibiotic families must be banned in veterinary medicine; whereas the Commission should specify which antibiotics or groups of antibiotics are to be reserved for the treatment of certain infections in humans;
Amendment 79 #
Draft opinion Paragraph 5 5. Stresses that disease prevention must be the first step for legislation tackling AMR in agriculture, both to ensure a high standard of animal welfare and reduce the need to resort to antibiotics;
Amendment 8 #
Motion for a resolution Citation 14 a (new) – having regard to the Seventieth World Health Assembly, Resolution on improving the prevention, diagnosis and clinical management of sepsis of 29 May 2017;
Amendment 8 #
Draft opinion Paragraph 1 1. Stresses that antimicrobial resistance (AMR) is a
Amendment 80 #
Draft opinion Paragraph 5 a (new) 5a. Recalls the preventative measures to be used before resorting to antimicrobial treatment of entire groups (metaphylaxis) of food-producing animals: – using good healthy breeding stock that grows naturally, with suitable genetic diversity, – conditions that respect the behavioural needs of the species, including social interactions and hierarchies, – stocking densities that do not increase risk of disease transmission, – isolation of sick animals away from the rest of the group, – (for chickens and smaller animals) subdivision of flocks into smaller, physically separated groups, – implementation of existing rules on animal welfare already in cross compliance as set out in SMRs 11, 12, 13 of Annex II to Reg. 1306/20131a _________________ 1a Reg. 1306/2013 on the financing, management and monitoring of the CAP (OJ L 347, 20.12.2013, p.549), applying rules laid out in Dir. 98/58/EC on protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23); Dir. 91/630/EEC laying down minimum standards for the protection of pigs (OJ L 340, 11.12.1991, p. 33); Dir. 91/629/EEC laying down minimum standards for the protection of calves (OJ L 340, 11.12.1991, p. 28)
Amendment 81 #
Motion for a resolution 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 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 environment, which can be another source of resistant microorganisms; underlines the important role of the Commission in coordinating and monitoring national action plans carried out by Member States;
Amendment 81 #
Draft opinion Paragraph 5 a (new) 5a. Stresses that studies suggest 1a that exposure to herbicides and their commercial formulations at concentrations comparable to those associated with typical application rates in agricultural fields can develop tolerance to antibiotics in offending bacteria; _________________ 1aKurenbach at al., 2015: Sublethal exposure to Commercial Formulations of the Herbicides Dicamba,2,4- Dichlorophenoxyacetic Acid, and Glyphosate Cause Changes in Antibiotic Susceptibility in Escherichia coli and Salmonella enterica
Amendment 82 #
Motion for a resolution Paragraph 1 1. Believes that in order to take sufficient steps to tackle AMR, the One Health or Health Chain principle must play a central role, reflecting the fact that the health of people
Amendment 82 #
Draft opinion 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 83 #
Motion for a resolution 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
Amendment 83 #
Draft opinion Paragraph 5 b (new) 5b. Recognizes that herbicides are routinely tested for toxicity but not for sublethal effects on microbes and stresses, for the reasons above, the relevance of consideration of conducting these tests routinely;
Amendment 84 #
Motion for a resolution 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 84 #
Draft opinion 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 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
Amendment 85 #
Draft opinion Paragraph 5 c (new) 5c. Proposes that any authorisation of a herbicide-resistant genetically modified crop (supposedly treated with herbicide to which it is tolerant) take fully into account precautionary principle with respect to indication of the existing link between use of herbicides and antimicrobial resistance and that for any there be a conclusive scientific evidence that such risk can be excluded;
Amendment 86 #
Motion for a resolution 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 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 environment and agricultural practices, which can be another source of resistant microorganisms;
Amendment 86 #
Draft opinion Paragraph 6 6. Calls on the Commission and the Member States to ensure adequate funding for on-farm investments, such as in spacious quality housing suitable for stockbreeding, ventilation, cleaning, disinfection, vaccination and bio-security;
Amendment 87 #
Motion for a resolution 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 are interconnected and that diseases are transmitted from people to
Amendment 87 #
Draft opinion Paragraph 6 6.
Amendment 88 #
Motion for a resolution Paragraph 1 a (new) 1a. Deplores the fact, in this context, that the Commission did not propose a strategic approach to the pollution of water with pharmaceuticals sooner, as required by Directive 2013/39/EU1 a; urges the Commission and Member States therefore, without delay, to draw up a European strategy for tackling drug residues in water and the environment, devoting sufficient attention to monitoring, data collection and better analysis of the impact of AMR on water resources and the aquatic ecosystem; draws attention to the usefulness of an integrated chain approach to drug residues and antimicrobial resistance in the environment2 a; _________________ 1a Article 8c. 2a As formulated in the Netherlands by the Ministry of Infrastructure and Public Works, the National Institute for Public Health and the Environment (RIVM), the water industry and water boards.
Amendment 88 #
Draft opinion Paragraph 6 6. Calls on the Commission and the Member States to ensure adequate funding for on-farm investments, such as in quality housing, ventilation, cleaning, disinfection, the use and application of manures on land, vaccination and bio-security;
Amendment 89 #
Motion for a resolution Paragraph 1 a (new) 1a. Calls for phasing out routine prophylactic and metaphylactic use and proposes that the use of the last-resort antibiotics be banned altogether in food- producing animals. Instead of routine (mis)use of antibiotics calls for improved housing and breeding conditions for food- producing animals as positive association can be seen between high-standard animal welfare and reduced antimicrobial use, which is crucial to curb bacterial resistance.
Amendment 89 #
Draft opinion Paragraph 6 6. Calls on the Commission and the Member States to ensure adequate funding for on-farm investments, such as in quality housing, ventilation, cleaning, disinfection,
Amendment 9 #
Motion for a resolution 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 9 #
Stresses, therefore, the importance of having harmonised data on the use of antimicrobials in the livestock sector;
Amendment 90 #
Motion for a resolution Paragraph 1 a (new) 1a. Stresses that pollution of water and soil by human and veterinary antibiotic residues is a growing problem and that the environment itself is a potential source of new resistant micro- organisms; calls therefore on the Commission to pay significantly more attention to the environment as part of the concept of 'One Health';
Amendment 90 #
Draft opinion Paragraph 6 a (new) 6a. Notes that the European One Health Action Plan against Antimicrobial Resistance (AMR) observes that immunisation by means of vaccination is a cost-effective health intervention in efforts to combat AMR1 a and that, in the Action Plan, the Commission announces incentives to promote the use of diagnostics, antimicrobial alternatives and vaccines2 a, but that relatively higher costs of diagnosis, antimicrobial alternatives and vaccination as compared with conventional antibiotics are an obstacle to raising the vaccination rate, as the Action Plan aims to do3 a; underlines that various Member States already regard vaccination as an important policy measure, both to prevent outbreaks of animal diseases across borders and to restrict further risks of contagion for the European agricultural market, and have introduced it; _________________ 1a European Commission (29 June 2017), A European One Health Action Plan against Antimicrobial Resistance (AMR), p. 10. 2a Ibid., p. 12. 3a Ibid., p. 15.
Amendment 91 #
Motion for a resolution Paragraph 1 a (new) 1a. Recalls that 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;
Amendment 91 #
Draft opinion Paragraph 6 a (new) 6a. Calls on the Commission to put in place restrictions on live animal transport from zones where antimicrobial-resistant strains of bacteria have been identified by the current monitoring system;
Amendment 92 #
Motion for a resolution Paragraph 1 a (new) 1a. Recalls that continuously updated information on the real burden of AMR is necessary; emphasizes the magnitude of the problem will also underline the clear European-added value of the European One Health Action Plan against AMR;
Amendment 92 #
Draft opinion Paragraph 6 a (new) 6a. Notes the importance of promoting and applying good practices at all stages of production and processing of food products from animals and protein sources;
Amendment 93 #
Motion for a resolution 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 93 #
Draft opinion Paragraph 6 a (new) 6a. Highlights that effective sanitation, hygiene and infection prevention measures help to reduce the incidence of infection;
Amendment 94 #
Motion for a resolution Paragraph 1 a (new) 1a. Calls, for that reason, for possible primary and secondary antimicrobial effects to be included in the evaluation of phytosanitary products and chemical products in general;
Amendment 94 #
Draft opinion Paragraph 6 b (new) 6b. Calls on the Member States to take further steps to raise the vaccination rate in the industry and thus tackle these diseases and antibiotic resistance cost- effectively; calls on the Commission and Member States — including in the context of the reform of the Common Agricultural Policy — to bring about more synergies and, in accordance with the findings set out in the Commission’s One Health Action Plan against antimicrobial resistance (AMR), to provide financial rewards, incentives and support for livestock farmers who can demonstrate that they have reduced their use of antibiotics and achieved a high vaccination rate of their animals;
Amendment 95 #
Motion for a resolution Paragraph 1 b (new) 1b. Stresses that in light of findings on changes in antibiotic susceptibility in bacteria when exposed to commercial formulations of herbicides, tests for sub- lethal effects of these on microbes could start to be conducted routinely; Proposes that any authorisation of a herbicide- resistant genetically modified crop (supposedly treated with herbicide to which it is tolerant) take fully into account precautionary principle with respect to indication of the existing link between use of herbicides and antimicrobial resistance and that for any there be a conclusive scientific evidence that such risk can be excluded.
Amendment 95 #
Draft opinion Paragraph 7 7. Emphasises the crucial role of education
Amendment 96 #
Motion for a resolution Paragraph 1 b (new) 1b. Underlines the importance of exchanges of best practices between Member States and the coordination of such exchanges by the Commission; welcomes in this context the reduction of the use of antibiotics in animal husbandry in the Netherlands by 64.4% in the period 2009-2016 and the stated national ambition to further reduce it by 2020; calls on the Commission and Member States to apply this example of public- private cooperation between public authorities, industries, scientists and veterinary surgeons in other parts of the Union as well;
Amendment 96 #
Draft opinion Paragraph 7 7. Emphasises the crucial role of education and training programmes in
Amendment 97 #
Motion for a resolution 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 97 #
Draft opinion 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
Amendment 98 #
Motion for a resolution Paragraph 1 c (new) 1c. Draws attention furthermore to recent scientific research results (February 2018) which show that ESBLs (Extended Spectrum Bèta-Lactamases) are transferred to people from livestock farming and meat consumption only to a limited extent and that the transmission of ESBLs mainly occurs from person to person1 a; _________________ 1a Mevius, D. et al. (2018). Rapport ESBL-Attributieanalyse(ESBLAT). Op zoek naar de bronnen van antibioticaresistentie bij de mens. http://www.1health4food.nl/esblat (Wageningen University, Utrecht University, RIVM)
Amendment 98 #
Draft opinion Paragraph 7 7. Emphasises the crucial role of education and training programmes, based on the latest scientific developments, in raising awareness about antimicrobial resistance and the prudent use of
Amendment 99 #
Motion for a resolution Paragraph 1 d (new) 1d. Calls on the Commission and Member States, on account of this recent research1 a, to take care and maintain a sense of proportion in adopting measures, and to carefully assess and classify 'antibiotics' and 'antimicrobial resistance' in all relevant legislation in order to avoid unnecessarily restricting the availability of remedies to combat certain protozoa, such as coccidia, in European livestock farming and thus unintentionally causing an increase in the risks of contamination of human beings with dangerous bacteria such as salmonella and microbes from food; _________________ 1a Mevius, D. et al. (2018). Rapport ESBL-Attributieanalyse(ESBLAT). Identify the sources of antibiotic resistance in humans. http://www.1health4food.nl/esblat
Amendment 99 #
Draft opinion Paragraph 7 7. Emphasises the crucial role of education and training program
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