Activities of Michèle RIVASI related to 2019/2816(RSP)
Institutional motions (1)
MOTION FOR A RESOLUTION on a strategic approach to pharmaceuticals in the environment
Amendments (31)
Amendment 5 #
Citation 1 a (new)
- having regard to Article 191 (2) of the Treaty on the Functioning of the European Union,
Amendment 15 #
Citation 17 a (new)
- having regard to the Commission Communication of the 11 December 2019 entitled ‘European Green Deal’ (COM(2019) 640) and the Resolution of the Parliament of 15 January 2020 in response,
Amendment 25 #
Citation 22 a (new)
- having regard to the OECD study of November 2019 "Pharmaceutical Residues in Freshwater - Hazards and Policy Responses"7a, _________________ 7a https://www.oecd.org/publications/pharm aceutical-residues-in-freshwater- c936f42d-en.htm
Amendment 39 #
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 environmental concentrations are likely to increase further as the population grows and ages; whereas the largest source of pharmaceuticals entering the environment is their use and disposal;
Amendment 49 #
Recital D a (new)
D a. whereas the OECD in its latest report on pharmaceutical residues in freshwater found that "current policy approaches to manage pharmaceutical residues are inadequate for the protection of water quality and freshwater ecosystems upon which health lives depend";
Amendment 59 #
Recital G
G. whereas there is sufficient evidence that action should be taken to reduce the risk from pharmaceuticals in the environment, especially for the protection of waters used for the abstraction of drinking water;
Amendment 65 #
Recital I
I. whereas the Commission had committed to propose measures to reduce the potentially harmful impacts of pharmaceuticals on the environment already in 20089 ; _________________ 9Commission Communication of 10 December 2008 entitled ‘Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector’ (COM(2008)666)
Amendment 70 #
Recital L
L. whereas there is self-regulation to limit the negative impac project iPiE (Intelligent Assessment of pPharmaceuticals in the eEnvironment, such as iPiE (Intelligent Assessment of Pharmaceuticals in the Environment)) to prioritise new and existing medicinal compounds for a comprehensive environmental risk assessment was concluded in June 2019;
Amendment 73 #
Recital L a (new)
L a. whereas the OECD advocates four proactive strategies with a focus on preventive options early in a pharmaceutical's life cycle to cost- effectively manage pharmaceuticals in the environment and to deliver the most long- term and large-scale environmental benefits;
Amendment 84 #
Paragraph 5
5. Considers that a holistic approach is needed to tackle pharmaceutical pollution, taking into account the entire life cycle of drugs; stresses that regulatory actions have to be taken in particular at source, in line with the precautionary principle and the principle that environmental damage should as a priority be rectified at source; highlights that the polluter pays principle as well as extended producer responsibility should be apply, primarily covering the manufacturing process, butied, covering all the stages of the life cycle, while also incentivising better prescription practices and responsible consumer behaviour;
Amendment 102 #
Paragraph 7
7. Recalls that studies have shown that pharmaceutical products are especially present in water bodies, and that they are ineffectively filtered byremoved by conventional wastewater treatment plants;
Amendment 109 #
Paragraph 9
9. Points to the need to regulateCalls on the Commission to consider the impact of pharmaceuticals underon water legislation; recalls 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 reuseresources in the framework of the review of EU water legislation;
Amendment 121 #
Paragraph 10
10. Asks for a special focus to be put on emission hot spots, such as hospitals and, pharmaceutical production plants and waste water treatment plants;
Amendment 122 #
Paragraph 10 a (new)
10 a. Calls on the Commission to also consider the impact of pharmaceuticals in the context of the zero-pollution action plan for air, water and soil announced by the Commission for 2021;
Amendment 126 #
Paragraph 10 b (new)
10 b. Calls on the Commission to develop Extended Producer Responsibility schemes to help finance necessary measures in line with the polluter pays principle;
Amendment 140 #
Paragraph 13
13. Calls on the Member States and on the Commission to promote awareness- raising campaigns and training among veterinaries and, physicians and pharmacists on the prudent use of pharmaceuticals, particularly of antimicrobials and anti- depressants; 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 to inform consumers how to properly dispose of unused medicines;
Amendment 163 #
Paragraph 16
16. Considers that the environmental impacts of pharmaceuticals cshould be included into the benefit-risk assessment of human medicines, as is already the case for veterinary medicines and calls on the Commission to make a legislative proposal accordingly;
Amendment 168 #
Paragraph 16 a (new)
16 a. Considers that the environmental assessment of pharmaceuticals should encompass their degradation products and metabolites;
Amendment 169 #
Paragraph 16 b (new)
16 b. Considers that pharmaceuticals that are harmful to the environment should only be available upon prescription;
Amendment 172 #
Paragraph 19
19. Calls on the Commission to ensure that the emission of pharmaceuticals to water is considered as a possible Key Environmental Issue when reviewing Best Available Techniques Reference Documents under the Industrial Emissions Directive for relevant sectors;
Amendment 173 #
Paragraph 19 a (new)
19 a. Furthermore calls on the Commission to include intensive farming into the next review of the Industrial Emissions Directive;
Amendment 177 #
Paragraph 20
20. Points to the important role of procurement policy in promoting greener pharmaceuticals in design and manufacturing; calls on the Commission to develop clear guidance on this issue;
Amendment 182 #
Paragraph 21 a (new)
21 a. Calls on the Commission to take all necessary action so that compulsory environmental criteria are included in the Good Manufacturing Practice (GMP) framework;
Amendment 187 #
Paragraph 22
22. Considers thatalls on the Commission to swiftly set up a clear road map for completing environmental risk assessments is needed, where those are not availablefor medicinal products for human use in the short term;
Amendment 193 #
Paragraph 24 a (new)
24 a. Calls for an update of the requirements with regard to the environmental risk assessment to ensure a proper environmental risk assessment of all relevant pharmaceuticals based on latest available science, to ensure a proper assessment of persistent, bioaccummulative and toxic substances, that additive effects as well as mixture effects are fully taken into consideration, as well as the risk of development of antibiotic resistance;
Amendment 217 #
Paragraph 29
29. Considers that pharmaceutical production plants should pre-treat their wastewater applying Best Available Techniques;
Amendment 234 #
Paragraph 32
32. Is concerned that monitoring of pharmaceuticals in the environment, in particular in soil, 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 not adequately and systematically covering the environmental data deficit;
Amendment 241 #
Paragraph 33 a (new)
33 a. Calls on the Commission to include pharmaceuticals that pose a significant risk to the environment in the list of priority substances under the Water Framework Directive and set environmental quality standards and concentration limits under the Environmental Quality Standards Directive;
Amendment 245 #
Paragraph 35
35. Emphasises the need to support further research, particularly under the next multi-annual financial framework, on the direct impact on human health and the environment due tof exposure to pharmaceuticals and their residues in the environment and on better understanding how pharmaceuticals enter and persist in the environment;
Amendment 249 #
Paragraph 36
36. Considers that the methods of analysis to quantify the presence of pharmaceuticals in the environment should be improved and that analytical detection methods should be made publicly available;
Amendment 256 #
Paragraph 37
37. Recalls that pharmaceutical environmental information plays a key role for risk management and that this type of information should be made available toerefore calls on the Commission to make a legislative proposal to make this type of information available to the public and relevant stakeholders;