28 Amendments of Ulrike MÜLLER related to 2019/2816(RSP)
Amendment 34 #
Recital B
B. whereas the wide use of pharmaceuticals in human and veterinary medicines, including antimicrobial agents, has increased their concentrations in many environmental reservoirs such as soils, sediments and waterbodies in the past 20 years; whereas the population grows and ages and the environmental concentrations are likely to increase, and the impact of climate change will affect both the quantity and the quality of water resources as at times of drought concentrations will be higher; whereas there is a need for more widespread gathering to measure this problem around the world; whereas the largest source of pharmaceuticals entering the environment is their use and disposal;
Amendment 45 #
Recital D
D. whereas the excessive and incorrect use of antibiotics, particularly in livestock farming, and moreinappropriate use of antibiotics, and generally poor practices in both human and veterinary medicine, have progressively rendered antimicrobial resistance a massive threat to human and animal health;
Amendment 53 #
Recital E
E. whereas pharmaceuticals authorised for human use and put on the market before 2006 were not subject to an environmental risk assessment as part of the authorisation process and might therefore still lack such an assessment;
Amendment 57 #
Recital G
G. whereas there is sufficient evidence that action should be taken to reduce the risknegative environmental impact from some pharmaceuticals in the environment, especially their impact on the development and spread of antimicrobial resistance;
Amendment 64 #
Recital H
H. whereas the environmental impact of pharmaceuticals has been recognised as an issue of concern by a large number of international organisations, third countries, European institutions, industry associations and Non-Governmental Organisations; whereas Germany, Sweden and the Netherlands have already taken action to address the growing presence of pharmaceuticals in the environment;
Amendment 66 #
Recital K
K. whereas in its conclusions of June 2019, the Council called upon the Commission “to assess and define the most effective measures, including legislative measures, to mitigate the effects of pharmaceuticals in the environment and to combat the development of antimicrobial resistance and to reinforce the link with the health sector in this regard”; whereas the Council acknowledged that further research is required to better understand the extent of the emerging human health and environmental impact of pharmaceuticals and their residues;
Amendment 71 #
Recital L a (new)
L a. whereas the AMR Industry Alliance has developed industry-driven principles of the Common Antibiotic Manufacturing Framework and determined targets for antibiotic discharge concentration in order to protect ecological resources and lower the potential risk of AMR development in the environment;
Amendment 74 #
Recital L b (new)
L b. whereas the Pharmaceutical Supply Chain Initiative (PSCI) has been launched to define, implement and improve responsible supply chain practices, including to minimise negative impacts on the environment;
Amendment 75 #
Recital L c (new)
L c. whereas a campaign was launched by several stakeholders to raise awareness on how to dispose of unused or expired medicines appropriately in Europe as part of the #MedsDisposal initiative;
Amendment 79 #
Paragraph 3
3. Notes however with concern the veryTakes note of the soft nature of the measures included in the communication; considers that legislaeffective measures are needed in addition to non-legislative measuresorder to properly tackle pharmaceutical pollution and mitigate the negative impacts of pharmaceuticals in the environment;
Amendment 86 #
Paragraph 5
5. Considers that a holisticmultistakeholder approach is needed to tackle pharmaceutical pollution, taking into account the entire life cycle of drugmedicines; stresses that regulatory actions have to be taken in line with the precautionary principle; highlights that the polluter pays principle should apply, primarily covering the manufacturing process, but also incentivising better prescription practices and consumer behaviour; Calls on the Commission to consider the use of extended producer responsibility to decrease the negative impacts of pharmaceuticals on the environment;
Amendment 92 #
Paragraph 6
6. Highlights that emissions of pharmaceuticals into the environment may not only harm ecosystems, but may also undermine the effectiveness of these same pharmaceuticals, especially in the case of antibiotics, as they can cause the emergence of antibiotic resistance;
Amendment 99 #
Paragraph 7
7. Recalls that studies have shown that pharmaceutical products and residues are especially present in water bodies, and that they are inot always effectively filterremoved by wastewater treatment plants;
Amendment 105 #
Paragraph 8
8. Notes that due to generally low concentrations, risks are more related to possible cumulative effects of long-term low-dose exposure than to acute or immediate health effects; is particularly concerned by the endocrine disrupting properties of manycertain pharmaceuticals ending up in the environment;
Amendment 113 #
Paragraph 9
9. Points to the need to regulate pharmaceuticals under water legislation; rRecalls that interinstitutional negotiations are on-going on a review of the Directive on the quality of water intended for human consumption and on a regulation on minimum requirements for water reuse;
Amendment 129 #
Paragraph 11
11. Calls on the Commission to facilitate the exchange of existing best practices among Member States and stakeholders, including initiatives such as iPiE, the Eco-pharmaco-Stewardship (EPS) and the #MedsDisposal campaign;
Amendment 133 #
Subheading 2
Increase awareness and promote prevention measures and prudent use of pharmaceuticals;
Amendment 135 #
Paragraph 12
12. Calls on the Member States to share best practices in the preventive use of antibiotics and to reinforcefully implement the ‘One Health Action Plan Against Antimicrobial Resistance’; reaffirms the positions expressed in its resolution of 13 September 2018 on a European One Health Action Plan against Antimicrobial Resistance;
Amendment 136 #
Paragraph 13
13. Calls on the Member States and on the Commission to promote awareness- raising campaigns and training among veterinaries and physician, pharmacists, physicians, healthcare professionals and patients on the prudent use of pharmaceuticals, particularly of antimicrobials; calls on actors in the pharmaceutical supply chain to contribute to providing to patients with sufficient information on how incorrectly disposed medicines may negatively impact the environment; calls for on-pack labelling in the form of an appropriate pictogramme and a single unit dose barcoding to inform consumers how to properly use and dispose of unused medicines;
Amendment 145 #
Paragraph 13 a (new)
13 a. Calls on the Commission and Member States to promote vaccination as a disease prevention measure, to minimise the need of pharmaceuticals;
Amendment 154 #
Paragraph 15
15. Calls on Member States and the Commission to support theresearch and development of pharmaceuticals intrinsically less harmful for the environment (‘greener pharmaceuticals’), which degrade more readily, into harmless substances, in wastewater treatment plants and theby reducing, as far as possible, the pharmaceutical characteristics that affect environmental risks;
Amendment 175 #
Paragraph 20
20. Points to the important role of procurement policy in promoting greener pharmaceuticals that are intrinsically less harmful for the environment; calls on the Commission to develop clear guidance on this issue;
Amendment 191 #
Paragraph 24
24. Considers it appropriate that pharmaceutical companies submitperform a joint environmental risk assessment per active substancfor similar products where appropriate so as to have coherent information, avoid duplication of work and reduce animal testing; Recalls the Commission is due to evaluate the feasibility of setting up an EU-wide active substance-based review system by 28 January 2022;
Amendment 204 #
Paragraph 27
27. Considers that the overall per capita drug consumption should be reduced, without jeopardising patients’ health; is of the opinion that the overall per animal veterinary medicines consumption should also decrease without compromising animal health and welfare;
Amendment 209 #
Paragraph 28
28. Considers that a review of Directive 86/278/EEC on sewage sludge is long overdue; calls on the Commission to make a legislative proposal to review and update Directive 86/278/EEC no later than by the end of 2020, not least so as to avoid that pharmaceutical residues are spread onto fieldsin order to update quality standards according to the latest scientific evidence to promote a true circular economy which does not harm human health and the environment;
Amendment 222 #
Paragraph 30
30. Calls foron the Member States to set up and fully enforcement of the existing provisions with regard to take- back schemes for unused medicines;
Amendment 229 #
Paragraph 31 a (new)
31 a. Calls on the Commission and Member States to support research, innovation and development of more advanced waste water treatment technologies that can detect and improve the removal of pharmaceutical residues;
Amendment 233 #
Paragraph 32
32. Is concerned that monitoring of pharmaceuticals in the environment is still very limited; stresses the need to strengthen post-marketing control mechanisms into comprehensive monitoring, also with regard to environmental effects, as the current surveillance system (pharmacovigilance) is noto adequately and systematically covering the environmental data deficit;