Activities of Lieve WIERINCK related to 2017/2254(INI)
Plenary speeches (1)
A European One Health Action Plan against Antimicrobial Resistance (debate) NL
Amendments (29)
Amendment 17 #
Motion for a resolution
Recital A
Recital A
A. whereas the excessive and inappropriatecorrect use of antibiotics and poor infection control practices in both human and veterinary medicine have progressively rendered antimicrobial resistance (AMR) a massive threat to humankind;
Amendment 25 #
Draft opinion
Recital C a (new)
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 31 #
Draft opinion
Paragraph 1
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 35 #
Motion for a resolution
Recital B
Recital B
B. whereas the misincorrect use 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;
Amendment 36 #
Draft opinion
Paragraph 1 a (new)
Paragraph 1 a (new)
1a. Urges the need to enable antimicrobial stewardship in order to improve evidence-based prescribing;
Amendment 41 #
Draft opinion
Paragraph 1 b (new)
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 44 #
Draft opinion
Paragraph 1 c (new)
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 49 #
Draft opinion
Paragraph 2 – subparagraph 1 (new)
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 53 #
Draft opinion
Paragraph 2 a (new)
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 63 #
Motion for a resolution
Recital E a (new)
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 67 #
Draft opinion
Paragraph 3 a (new)
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 70 #
Draft opinion
Paragraph 3 b (new)
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 75 #
Draft opinion
Paragraph 4 a (new)
Paragraph 4 a (new)
4a. Emphasises the need to analyse big data coming from different industry sectors;
Amendment 77 #
Draft opinion
Paragraph 4 b (new)
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)
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)
Paragraph 4 d (new)
Amendment 85 #
Draft opinion
Paragraph 5 a (new)
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 102 #
Motion for a resolution
Paragraph 2
Paragraph 2
2. Stresses that the appropriatecorrect 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;
Amendment 246 #
Motion for a resolution
Paragraph 11 a (new)
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 258 #
Motion for a resolution
Paragraph 12
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 304 #
Motion for a resolution
Paragraph 14 a (new)
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 327 #
Motion for a resolution
Paragraph 16
Paragraph 16
Amendment 366 #
Motion for a resolution
Paragraph 21
Paragraph 21
21. Calls on the Commission and the Member States to support the implementation of new economic models, pilot projects and various push and pull incentives to boost the development of new diagnostics, antibiotics, alternatives and vaccines;
Amendment 374 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Notes the hesitant approach of the industry to develop ‘last-line’ antibiotics against bacteria that are resistant to all other antibiotics owing to expected low profitabilityat the business model for developing medicines is not suitable for antibiotic development since resistance can evolve over time and because they are meant to be used as a last resort; calls for incentives for this research and definition of the regulatory pathway;
Amendment 379 #
Motion for a resolution
Paragraph 22
Paragraph 22
22. Notes the hesitant approach ofvarious challenges faced by the industry to develop ‘last-line’ antibiotics against bacteria that are resistant to all other antibiotics owing to expected low profitabilitya lack of business-case; calls for incentives for this research and definition of the regulatory pathway;
Amendment 384 #
Motion for a resolution
Paragraph 23
Paragraph 23
23. Calls on the Commission and Member States to develop new incentive models that delink payment from prescribing volume 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 390 #
Motion for a resolution
Paragraph 23
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 394 #
Motion for a resolution
Paragraph 23 a (new)
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;