Parltrack

Activites

• 2012/12/11 Text adopted by Parliament, single reading
  • T7-0483/2012
• 2012/12/10 Debate in Parliament
• 2012/11/15 Committee report tabled for plenary, single reading
  • A7-0373/2012 summary

    The Committee on the Environment, Public Health and Food Safety unanimously adopted the initiative report by Anna ROSBACH (ECR, DK) on “the Microbial Challenge – Rising threats from Antimicrobial Resistance”. Members recall that resistance to antibiotics for certain bacteria is as high as 25 % or more in several Member States and that much of the antimicrobial resistance (AMR) problem stems from the misuse – in particular excessive use – of antibiotics. They also highlight the fact that many Member States do not have a solid legal and regulatory framework to mandate and support the rational use of medicines. As a result, Members call for the complete and rapid implementation of measures in this area. Although they welcome the Commission’s five-year planstrategic Action Plan on tackling AMR and view it as generally going in the right direction, Members note that many of the action points reiterate measures prescribed over a decade ago, it is not sufficient for tackling the growing risk presented by AMR at international level. In this context, Members call for an integrated roadmap outlining relevant policy responses, including possible legislative action. Members call in particular for the Action Plan to: cover all animals under the EU animal welfare strategy, including, for instance, companion animals and animals used for sports, and emphasise the logical connection between animal health and the use of antimicrobials, as well as the link between animal health and human health. Prudent use of antimicrobials in human and veterinary medicine: Members call for the prudent use of antimicrobials. The key objective of any AMR strategy is to maintain the efficiency of existing antimicrobials by using them responsibly at the correct therapeutic level only when strictly necessary and prescribed over a specific time at the appropriate dosage (and not for treating viral infections). Similar prudence needs to be exercised in veterinary medicine. Members call on the Member States to use electronic recording systems to ensure that usage patterns on individual farms are appropriate, thus ensuring responsible and minimal use. They also suggest to the Commission that current provisions on maximum animal density in livestock farming be re-evaluated as herd sizes today often present obstacles to the treatment of individual or smaller groups of animals, providing incentives for the prophylactic use of antimicrobials. They also call for a legislative proposal to be presented for the veterinary sector to limit its use of third- and fourth-generation Critically Important Antimicrobials (CIAs) for humans. The Commission and the Member States are also invited to encourage efforts to study hospital outbreaks, to improve diagnostics but also to assess and monitor the Member States' implementation of relevant EU legislation on antimicrobials, in particular with regard to the prescription-only use of antibiotics in the human health and veterinary sectors. Prevention: Members call for more effective measures to be introduced to prevent both the appearance and the spread of antimicrobial resistance. These measures include better monitoring and better notification of micro-organisms resistant to antimicrobials, as well as a more effective combating of infections, in particular by means of vaccinations. Among other measures they call for limits on uncontrolled access to antimicrobial agents, in particular via the growing number of illegal sales on the internet, and their inappropriate use. They call on the Member States to improve infection control, and to raise and promote good standards of hygiene – especially hand hygiene, – in order to prevent the spread of infections and reduce the need for antibiotics. Development of new antimicrobials or alternatives for treatment: Members consider it vital to limit the emergence of bacteria that are resistant to antimicrobials. In this context, it is necessary to develop new antimicrobial agents. In parallel, Members stress the advantages of public-private partnerships because these can contribute to reaching this objective by dissociating sales transactions from investment in research and development. In this area, Members call on the Commission and the Member States to accelerate R&D activities in order to provide new tools to fight tuberculosis and drug-resistant tuberculosis. Members also underline the need to examine new regulatory approaches that would result in stimulating industrial research and the development of new antimicrobials while safeguarding patient safety. They also call on the Commission to ensure the development and availability of more on-farm tools for early, rapid diagnosis and control of diseases, as well as for a broad and effective diagnostic system at Member State level. Monitoring and reporting: in this field, Members call on the Commission and the Member States to seek greater cooperation and coordination on early detection, alert and coordinated response procedures regarding pathogenic antimicrobial resistant bacteria in humans, animals, fish and foodstuffs. They call on Member States to compile clear, comparable, transparent and timely reference data on antimicrobial drug usage so that effective action can be undertaken. They consider, however, that data gathered on the use of antibiotics should be made accessible only to the experts, authorities and decision-makers concerned. They call on the Member States to ensure separate monitoring and control of resistance among livestock, domestic animals and racing animals. Communication, education and training: Members note that one of the most common uses for antibiotics is as treatment against the common cold, and that much would be gained if the public could be made aware of the fact that the common cold is a viral infection whereas antibiotics only provide protection against bacterial infections. They call on the Commission to compile a best practice list with regard to the implementation of effective communication campaigns and professional training courses aimed at raising AMR awareness. They believe that effective information and awareness campaigns must be developed with a view to heightening awareness of the dangers of the unintentional spread of antimicrobial pathogens in hospitals and in the home, and awareness of the means of avoiding this. Campaigns along the lines of "Please take this antibiotic medicine only if it is prescribed by a doctor to you and take it as prescribed” should be promoted and included in the package leaflet. International cooperation: lastly, Members believe that concerted and timely international action that avoids overlap and builds critical mass is the only way forward in minimising the threat to public health that AMR poses globally.They consider that the work undertaken by the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) should be used as a model for international cooperation on antimicrobial resistance. Other similar multilateral and bilateral commitments for the prevention and control of AMR should also be encouraged, in accordance with the guidelines laid down by the WHO (in particular in regard to the control of counterfeit antimicrobials).

• 2012/11/06 Vote in committee, 1st reading/single reading
  • AGRI HÄUSLING Martin Verts/ALE
  • ENVI ENVI/7/08364 ROSBACH Anna EFD
  • ITRE
• 2012/10/16 Amendments tabled in committee
  • PE496.577
• 2012/09/19 Amendments tabled in committee
  • PE496.371
• 2012/07/12 Committee draft report
  • PE486.077
• #3177
• 2012/06/21 Council Meeting
• 2012/03/15 Committee referral announced in Parliament, 1st reading/single reading
  • AGRI HÄUSLING Martin Verts/ALE
  • ENVI ENVI/7/08364 ROSBACH Anna EFD
  • ITRE
• 2011/11/15 Non-legislative basic document
  • COM(2011)0748 summary

    PURPOSE: to establish an action plan against the rising threats from Antimicrobial Resistance (AMR). BACKGROUND: since the introduction of penicillin in the 1940s antimicrobial medicines, such as antibiotics, have become essential for the treatment of many microbial infections in humans and animals. In addition to the treatment of infectious diseases (e.g. pneumonia, tuberculosis, malaria, HIV/AIDS) and hospital-acquired infections (e.g. methicilin resistant Staphylococcus aureus (MRSA), antimicrobials are vital for reducing the risk of complications in relation to complex medical interventions, such as hip replacements, organ transplants, cancer chemotherapy and the care of premature babies. In addition, antimicrobials are used in veterinary medicine and for non-therapeutic purposes (e.g. disinfectants, preservatives, and food and feed additives). Seventy years later, these applications are now seriously jeopardized by the emergence and spread of microbes that are resistant to affordable and effective firstchoice, or "first-line" medicines, rendering the drugs concerned ineffective for the treatment of the infection. This resistance is a natural biological phenomenon but is amplified by a variety of factors. The inappropriate use of therapeutic antimicrobials in human and veterinary medicine, the use of antimicrobials for non-therapeutic purposes as well as the pollution of the environment by antimicrobials is accelerating the emergence and spread of resistant microorganisms. The consequences are severe. The Commission recall that a subset of drug-resistant bacteria is responsible for about 25 000 human deaths annually. In addition to avoidable death, this also translates into extra healthcare costs and productivity losses of at least EUR 1.5 billion. For their part, the Council and the European Parliament have already examined this issue and on 12May 2011 the European Parliament adopted a non-legislative resolution on antibiotic resistance in which it stresses that AMR has become a huge issue in recent years. To cope with this growing problem and the consequent treatment failures, the EP calls on the Commission to establish an EU-wide plan to combat AMR. This Communication responds to this request. CONTENT: in this regard, the Commission has taken a number of important actions: in the field of human medicine, the 2001 Community Strategy against AMR called for EU actions against AMR in the fields of surveillance, research, prevention and international cooperation. This led to the adoption of EU wide recommendations and guidelines against AMR; in animal husbandry, the ban on the use of antimicrobials for growth promotion was introduced in 2006. The Commission has developed legislation on the control of Salmonella at all relevant stages of production, processing and distribution in order to reduce the exposure of humans to potentially resistant Salmonella; in the field of veterinary medicine, the emphasis has been in monitoring zoonotic AMR (i.e. resistance transmissible between animals and humans) and on the use of antimicrobials in animals; the authorisation requirements of human and veterinary medicines and other products, such as food enzymes, probiotics and decontamination agents, with possible effects on development of AMR have also been the focus areas; AMR is the subject of research funded under the Seventh Framework Programme (FP7) and the Innovative Medicines Initiative (IMI). AMR is also the subject of a proposed Joint Programming Initiative (JPI), which aim to coordinate research activities among EU Member States; scientific opinions on AMR by EU Risk Assessment bodies i.e. the European Centre for Disease Prevention and Control (ECDC), the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) have formed the basis for policy planning, for example, development of new antimicrobials and monitoring AMR and antimicrobial usage. Based on such holistic approach, the new actions put forward in this Action Plan aim at: mitigating the risk of developing AMR in humans from the use of antimicrobials both in humans and animals by effectively ensuring across the EU their appropriate use, and promoting microbiological diagnosis as the means to determine, to the extent possible, the need for antimicrobials; putting in place effective ways to prevent microbial infections and their spread; developing effective antimicrobials or alternatives for treatment of human and animal infections; joining forces with international partners to contain the risks of spreading AMR from international trade and travel and via the environment; reinforcing research to develop the scientific basis and innovative means to combat AMR. The Commission proposes to put in place a 5-year Action Plan to fight against AMR based on 12 key actions: Action n° 1: Strengthen the promotion of the appropriate use of antimicrobials in all Member States. Action n° 2: Strengthen the regulatory framework on veterinary medicines and on medicated feed. Action n° 3: Introduce recommendations for prudent use in veterinary medicine, including follow-up reports. Action n° 4: Strengthen infection prevention and control in healthcare settings. Action n° 5: Introduce of a legal tool to enhance prevention and control of infections in animals in the new Animal Health Law. Action n° 6: Promote, in a staged approach, unprecedented collaborative research and development efforts to bring new antimicrobials to patients. Action n° 7: Promote efforts to analyse the need for new antibiotics into veterinary medicine. Action n° 8: Develop and/or strengthen multilateral and bilateral commitments for the prevention and control of AMR in all sectors. Action n° 9: Strengthen surveillance systems on AMR and antimicrobial consumption in human medicine. Action n° 10: Strengthen surveillance systems on AMR and antimicrobial consumption in animal medicine. Action n° 11: Reinforce and co-ordinate research efforts. Action n° 12: Survey and comparative effectiveness research. Several Member States have been pro-active in carrying out actions related to those considered at EU level. These actions at national level and the experience gained from it should be the basis of the practical development and implementation of this Action Plan.

  • DG {u'url': u'http://ec.europa.eu/dgs/health_consumer/index_en.htm', u'title': u'Health and Consumers'}, BORG Tonio

Documents

• Non-legislative basic document published: COM(2011)0748
• Committee draft report: PE486.077
• Amendments tabled in committee: PE496.371
• Amendments tabled in committee: PE496.577
• Committee report tabled for plenary, single reading: A7-0373/2012
• Decision by Parliament, 1st reading/single reading: T7-0483/2012

Votes

A7-0373/2012 - Anna Rosbach - § 43/2

A7-0373/2012 - Anna Rosbach - Résolution

A7-0373/2012 - Anna Rosbach - Resolution

History

(these mark the time of scraping, not the official date of the change)