2019/2816(RSP) | [ParlTrack]

Citation 9 a (new)

- having regard to Directive 2008/56/ CE on the Marine Strategic Framework,

Amendment 100 #

Paragraph 7

7. Recalls that studies have shown that residue from pharmaceutical products ~~are~~is especially present in water bodies, and that ~~they are ineffectively filtered by~~it is not completely removed by conventional wastewater treatment plants;

Amendment 101 #

Alexander BERNHUBER

Paragraph 7

7. Recalls that studies have shown that pharmaceutical products are especially present in water bodies, and that they are ineffectively ~~filtered by~~removed by conventional wastewater treatment plants;

Amendment 102 #

Eleonora EVI, Daniela RONDINELLI, Piernicola PEDICINI

Paragraph 7

Amendment 103 #

Paragraph 8

8. Notes that due to generally low concentrations~~, risks~~ in drinking water, risks for human health 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 many pharmaceuticals ending up in the environment;

Amendment 104 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Paragraph 8

8. Notes that due to generally low concentrations, risks for human health 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 many pharmaceuticals ending up in the environment;

Amendment 105 #

Eleonora EVI, Daniela RONDINELLI, Piernicola PEDICINI

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 ~~many~~certain pharmaceuticals ending up in the environment;

Amendment 106 #

Paragraph 9

9. Points to the need to regulate pharmaceuticals under 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 reuse; Believes that pharmaceuticals should be regulated also in relation to soil. On this regard, it is appropriate that the Commission proposes an overview Directive on soil protection in the EU with specific actions on ways to address soil pollution from pharmaceuticals;

Amendment 107 #

Alexander BERNHUBER

Paragraph 9

9. Points to the need to regulate pharmaceuticals under 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 reusefact that the impact of pharmaceutical residues on water resources must be taken into account in the review of EU water legislation;

Amendment 108 #

Paragraph 9

9. Points to the need to regulate pharmaceuticals under water legislation through setting limits for concentration of antibiotic active pharmaceutical ingredients discharged in water; 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 reuse;

Amendment 109 #

Paragraph 9

9. ~~Points to the need to regulate~~Calls on the Commission to consider the impact of pharmaceuticals ~~under~~on 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 11 #

Citation 10 a (new)

- having regard to the Council conclusions of 24 June 2019 on the next steps towards making the EU a best practice region in combatting antimicrobial resistance,

Amendment 110 #

Mairead McGUINNESS

Paragraph 9

9. Points to the need to regulate pharmaceuticals under water legislation and notes that specific pharmaceuticals are regulated under the Water Framework Directive; 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 reuse;

Amendment 111 #

Paragraph 9

Amendment 112 #

Paragraph 9

Amendment 113 #

Paragraph 9

9. ~~Points to the need to regulate pharmaceuticals under water legislation; r~~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 reuse;

Amendment 114 #

Aldo PATRICIELLO

Paragraph 9

9. Points to the need to regulate pharmaceuticals under 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 reusake into account that specific pharmaceuticals are already regulated under the Water Framework Directive; recalls the importance of managing pharmaceuticals under the existing framework due to the public health role they serve;

Amendment 115 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Paragraph 10

10. Asks for a special focus to be put on emission hot spots, such as hospitals and pharmaceutical production plants, in accordance with the control at source principle, and additional hot spots such as certain wastewater treatment plants;

Amendment 116 #

Paragraph 10

10. Asks for a special focus to be put on emission hot spots, such as hospitals and pharmaceutical production plants in accordance with the control at source principle, and additional hot spots such as certain waste water treatment plants;

Amendment 117 #

Paragraph 10

10. ~~Asks for a special focus to be put~~Underlines the need to gather new and more detailed data on emission hot spots, such as hospitals and pharmaceutical production plants, and the use of digital and big data monitoring systems;

Amendment 118 #

Paragraph 10

10. Asks, with regard to the effectiveness of the measures being adopted, for a special focus to be put on emission hot spots, such as hospitals and pharmaceutical production plants;

Amendment 119 #

Eleonora EVI, Daniela RONDINELLI, Piernicola PEDICINI

Paragraph 10

10. Asks for a special focus to be put on emission hot spots, such as hospitals ~~and~~, pharmaceutical production plants and intensive stockbreeding areas;

Amendment 12 #

Citation 12 a (new)

- having regard to the Council Conclusions of 26 June 2019 on the next steps towards making the EU a best practice region in combatting antimicrobial resistance,

Amendment 120 #

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 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 123 #

Mohammed CHAHIM

Paragraph 10 a (new)

10 a. Calls on the Commission to develop Extended Producer Responsibility (EPR) schemes, in order to finance de pollution measures in line with the polluter pays principle;

Amendment 124 #

Tiemo WÖLKEN

Paragraph 10 a (new)

10 a. Calls on the Commission to develop Extended Producer Responsibility (EPR) schemes, in order to finance depollution measures in line with the polluter pays principle;

Amendment 125 #

Paragraph 10 a (new)

10 a. Calls on the Commission to develop Extended Producer Responsibility (EPR) schemes, in order to finance depollution measures in line with the polluter pays principle;

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 127 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Paragraph 11

11. Calls on the Commission to facilitate the exchange of existing best practices and to take clear legislative action on tackling pharmaceuticals in the environment, both as a result of the manufacturing process and of the use and disposal of pharmaceuticals;

Amendment 128 #

Paragraph 11

11. Calls on the Commission to facilitate the exchange of existing best practices, including those developed by stakeholders, such as iPiE, the Eco- Pharmaco-Stewardship(EPS), the AMR Alliance manufacturing framework and the #MedsDisposal campaign;

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 13 #

Citation 26 a (new)

- having regard to the Council conclusions of 24 June 2019 on the next steps towards making the EU a best practice region in combatting antimicrobial resistance,

Amendment 130 #

Bartosz ARŁUKOWICZ

Paragraph 11

11. Calls on the Commission to facilitate the exchange of existing best practices, including through raising awareness and promoting the re-use of medicine packaging;

Amendment 131 #

Paragraph 11

11. Calls on the Commission to facilitate the exchange of existing ~~best practices~~and promote good practice methods to reduce environmental impacts of manufacturing;

Amendment 132 #

Paragraph 11 a (new)

11 a. Encourages that those existing and self-regulated initiatives should be analysed and, where appropriate, considered as models in future EU initiatives on pharmaceuticals in the environment;

Amendment 133 #

Subheading 2

Increase awareness and promote prevention measures and prudent use of pharmaceuticals;

Amendment 134 #

Paragraph 12

12. Calls on the Member States to share best practices in the preventive use of antibiotics and to apply in full and, if necessary, reinforce 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 135 #

Paragraph 12

12. Calls on the Member States to share best practices in the preventive use of antibiotics and to ~~reinforce~~fully 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 137 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM

Paragraph 13

13. Calls on the Member States and on the Commission to promote awareness- raising campaigns a~~mong veterinaries and physicians on the prudent use of pharmaceuticals, particularly of antimicrobial~~nd training among healthcare professionals, including veterinaries, pharmacists, physicians and patients, on the prudent use of pharmaceuticals, such as antimicrobials, antidepressants or contrast fluids; 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 138 #

Draft motion for a resolution
Paragraph 13

13. Calls on the Member States and on the Commission to promote awareness- raising campaigns and trainings among veterinaries ~~and~~, physicians and pharmacists on the prudent use of pharmaceuticals, ~~particularly of antimicrobial~~such as antimicrobials, antidepressants or contrast fluids; 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 139 #

Paragraph 13

13. Calls on the Member States and on the Commission to promote awareness- raising campaigns and training courses among veterinaries and ~~physician~~healthcare professionals on the prudent use of pharmaceuticals, particularly of antimicrobials; calls on actors in the pharmaceutical supply chain to contribute to providing to patients with clear, 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 14 #

Citation 12 a (new)

- having regard to the Council conclusions of 24 June 2019 on the next steps towards making the EU a best practice region in combatting antimicrobial resistance,

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 141 #

Paragraph 13

13. Calls on the Member States and on the Commission to promote awareness- raising campaigns a~~mong~~nd training among pharmacists, veterinaries, and physicians 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 to inform consumers how to properly dispose of unused medicines;

Amendment 142 #

Paragraph 13

13. Calls on the Member States and on the Commission to promote awareness- raising campaigns among veterinaries and physicians on the prudent use of pharmaceuticals, particularly of antimicrobials; calls on actors in the pharmaceutical supply chain to contribute to providing to patients and stockbreeders 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 143 #

Paragraph 13 a (new)

13a. Stresses that health professionals must be kept continuously up to date regarding the latest developments in research and good practices when it comes to preventing the spread of AMR;

Amendment 144 #

Paragraph 13 a (new)

13 a. Calls on Member States to include the issue of pharmaceuticals in the environment in their cross-border cooperation in river basins, and to coordinate measures where they are deemed useful;

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 146 #

Paragraph 14

14. Highlights the importance of ~~the design, development and manufacturing phases to minimise the environm~~more rapid, ambitious and targeted measures to reduce the environmental risks posed by pharmaceuticals, while acknowledging the need for further research for a better understanding of the extent of the currental impact of pharmaceuticals on human health and the environment;

Amendment 147 #

Paragraph 14

14. Highlights the importance of the design, development and manufacturing phases to minimise the environmental impact of pharmaceuticals; has the opinion that the Good Manufacturing Practice (GMP) legislation should be revised to include requirements for environmental protection;

Amendment 148 #

Inese VAIDERE

Paragraph 14

14. Highlights the importance of the design, development and manufacturing phases to minimise the environmental impact of pharmaceuticals, meanwhile avoiding the price increase for the pharmaceuticals products;

Amendment 149 #

Paragraph 14 a (new)

14 a. Notes that, in relation to the healthcare sector, addressing any excessive workforce pressures on physicians is a necessary condition for healthcare professionals to ensure appropriate prescribing of antimicrobials; further notes that healthcare professionals could be further assisted via the provision of clear, evidence-based prescribing guidance that provides consistent advice across different clinical indications;

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 150 #

Paragraph 15

15. Calls on Member States and the Commission to support the development of pharmaceuticals intrinsically less harmful for the environment (‘greener pharmaceuticals’), which degrade more readily, into harmless substances, in wastewater treatment plants and the environment; taking into account that greater biodegradability could potentially impair the efficacy and shelf life of medicines, and make it harder to administer precise dosages;

Amendment 151 #

Maria SPYRAKI, Vangelis MEIMARAKIS, Elissavet VOZEMBERG-VRIONIDI, Georgios KYRTSOS, Anna-Michelle ASIMAKOPOULOU

Paragraph 15

15. Calls on Member States and the Commission to support ~~the~~research, development and innovation of pharmaceuticals ~~intrinsically~~which are equally effective for patients and less harmful for the environment (‘greener pharmaceuticals’), which degrade more readily, into harmless substances, in wastewater treatment plants and the environment; calls on the Member States and the Commission to boost funding for this;

Amendment 152 #

Paragraph 15

15. Calls on Member States and the Commission to support the research and development of pharmaceuticals intrinsically less harmful for the ~~environment (‘greener pharmaceuticals’), which degrade more readily, into harmless substances, in wastewater treatment plants and the~~ environment;

Amendment 153 #

Paragraph 15

15. Calls on Member States and the Commission to support ~~the~~and set financial incentives for research and development of pharmaceuticals intrinsically less harmful for the environment ~~(‘greener pharmaceuticals’), which degrade more readily, into harmless substances, in wastewater treatment plants and the environment~~, by reducing, as far as possible, the pharmaceutical characteristics that affect environmental risks such as ecotoxicity, persistence, mobility and bioaccumulation;

Amendment 154 #

Paragraph 15

15. Calls on Member States and the Commission to support ~~the~~research and development of pharmaceuticals intrinsically less harmful for the environment (‘greener pharmaceuticals’), ~~which degrade more readily, into harmless substances, in wastewater treatment plants and the~~by reducing, as far as possible, the pharmaceutical characteristics that affect environmental risks;

Amendment 155 #

Jessica POLFJÄRD

Paragraph 15

15. Calls on Member States and the Commission to support the development of pharmaceuticals ~~intrinsically less harmful for the environment (‘greener pharmaceuticals’), which~~with a smaller environmental footprint, inter alia by degradeing more readily, into harmless substances, in wastewater treatment plants and the environment;

Amendment 156 #

Silvia SARDONE, Aldo PATRICIELLO

Paragraph 15 a (new)

15a. Calls on the Member States and all stakeholders concerned to make use of EU programmes to invest in technology aimed at improving the effectiveness of the disposal of pharmaceutical products and antimicrobial-resistant genes whilst ensuring that such products are just as effective in terms of meeting patients' needs;

Amendment 157 #

Paragraph 16

~~16. Considers that the environmental impacts of pharmaceuticals could be included into the benefit-risk assessment of human medicines, as is already the case for veterinary medicines;~~deleted

Amendment 158 #

Paragraph 16

~~16. Considers that the environmental impacts of pharmaceuticals could be included into the benefit-risk assessment of human medicines, as is already the case for veterinary medicines;~~deleted

Amendment 159 #

Alessandra MORETTI

Paragraph 16

16. Considers that the environmental impacts of pharmaceuticals could be included into the benefit-risk assessment of human medicines, as is already the case for veterinary medicines, while making sure that no delay occurs in the marketing authorization procedure of drugs deemed suitable in accordance with the current criteria of the assessment itself, so as to guarantee prompt access to safe and effective pharmacological treatments for patients;

Amendment 16 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN

Citation 12 a (new)

- having regard to the Commission Communication of the 11 December 2019 entitled “European Green Deal” (COM(2019)640),

Amendment 160 #

Simona BALDASSARRE, Silvia SARDONE

Paragraph 16

16. Considers that the environmental impacts of ~~pharmaceuticals c~~new and existing pharmaceutical substances pharmaceuticals should be included into the benefit-risk assessment of human medicines, as is already the case for veterinary medicines; emphasises that metabolites, degradation products and cocktail effects of pharmaceutical substances should also be considered therein;

Amendment 161 #

Paragraph 16

16. Considers that the environmental impacts of pharmaceuticals could be included into the benefit-risk assessment of human medicines~~, as is already the case for veterinary medicine~~ by drawing up multiple comparative environmental risk assessment tables without compromising access to safe and effective pharmacological treatments;

Amendment 162 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Paragraph 16

16. Considers that the environmental impacts of pharmaceuticals ~~could~~shall be included into the benefit-risk assessment of human medicines, as is already the case for veterinary medicines; Metabolites, degradation products and cocktail effects of pharmaceutical substances shall also be considered therein;

Amendment 163 #

Eleonora EVI, Daniela RONDINELLI, Piernicola PEDICINI

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 164 #

Nicolae ŞTEFĂNUȚĂ

Paragraph 16

16. C~~onsiders that~~alls on the Commission to make a legislative proposal to include the environmental impacts of pharmaceuticals ~~could be included~~that are not deemed essential, into the benefit-risk assessment of human medicines, as is already the case for veterinary medicines;

Amendment 165 #

Paragraph 16

16. C~~onsiders that~~alls on the European Commission to make a legislative proposal to include the environmental impacts of pharmaceuticals ~~could be included~~ into the benefit-risk assessment of human medicines, as is already the case for veterinary medicines;

Amendment 166 #

Silvia SARDONE, Aldo PATRICIELLO

Paragraph 16

16. Considers ~~that~~it inappropriate to include the environmental impacts of pharmaceuticals ~~could be included~~ into the benefit-risk assessment of human medicines~~, as is already the case for veterinary medicines;~~ when it comes to ensuring that patients have access to safe and effective pharmaceutical treatments;

Amendment 167 #

Paragraph 16

16. Considers that the environmental impacts of pharmaceuticals could be an option to included into the benefit-risk assessment of human medicines, as is already the case for veterinary medicines;

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 17 #

Citation 17 a (new)

- having regard to the Commission Communication of the 11 December 2019 entitled ‘European Green Deal’ (COM(2019) 640),

Amendment 170 #

Nicolae ŞTEFĂNUȚĂ

Paragraph 17

17. Calls the Commission to take into account, where appropriate, ongoing existing efforts by stakeholders for future initiatives to reduce environmental risks ~~and~~ promote environmentally responsible practices and appropriate use and return of pharmaceuticals;

Amendment 171 #

Paragraph 18

18. Calls for monitoring data from the Water Framework Directive to include suitable parameters regarding the impact of pharmaceuticals that must be used for post-market evaluation;

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 174 #

Paragraph 20

20. Points to the important role of procurement policy in promoting ~~greener~~ pharmaceuticals which respect the environment; calls on the Commission to develop clear guidance on this issue; by including, for example, environmental criteria in addition to simple economic criteria;

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 176 #

Paragraph 20

20. Points to the important role of procurement policy in promoting ~~greener~~ pharmaceuticals with low intrinsic toxicity for the environment; calls on the Commission to develop clear guidance on this issue;

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 178 #

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 179 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

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 18 #

Citation 17 a (new)

- having regard to the Commission Communication of the 11 December 2019 entitled ‘European Green Deal’ (COM(2019) 640),

Amendment 180 #

Paragraph 21 a (new)

21 a. Calls on the Commission to include compulsory environmental criteria in the Good Manufacturing Practice (GMP) framework to give EU inspectors the ability to control manufacturing discharges at overseas pharmaceutical factories supplying the EU market;

Amendment 181 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Paragraph 21 a (new)

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 183 #

Eleonora EVI, Daniela RONDINELLI, Piernicola PEDICINI

Paragraph 21 a (new)

21 a. Calls on the European Medicines Agency to facilitate joint inspections of manufacturing discharges at overseas pharmaceuticals factories supplying the EU;

Amendment 184 #

Paragraph 22

22. Considers that a clear road map for completing environmental risk assessments is needed, where those are not available, in particular for those medicinal products which were authorised before 2006 and were not subject to an Environmental Risk assessment in their market authorisation process;

Amendment 185 #

Paragraph 22

22. Considers that a clear road map for completing environmental risk assessments on pharmaceuticals placed on the EU market is needed, where ~~those~~such assessments are not available;

Amendment 186 #

Paragraph 22

22. C~~onsiders that a clear road map for completing environmental risk assessments is needed, where those are not available~~alls on the Commission to initiate a systematic catching-up procedure for medicinal products for human use authorised without an environmental risk assessment;

Amendment 187 #

Eleonora EVI, Daniela RONDINELLI, Piernicola PEDICINI

Paragraph 22

22. C~~onsiders that~~alls on the Commission to swiftly set up a clear road map for completing environmental risk assessments ~~is needed, where those are not available~~for medicinal products for human use in the short term;

Amendment 188 #

Paragraph 22 a (new)

22 a. Calls on the Commission to include compulsory environmental criteria in the Good Manufacturing Practice (GMP) framework to give the possibility to EU inspectors to control discharges of third countries pharmaceutical factories supplying the EU;

Amendment 189 #

Paragraph 22 a (new)

22 a. Calls on the Commission to include compulsory environmental criteria in the Good Manufacturing Practice (GMP) framework to give EU inspectors the ability to control manufacturing discharges at overseas pharmaceutical factories supplying the EU market;

Amendment 19 #

Citation 17 a (new)

- having regard to the Commission Communication of the 11 December 2019 entitled ‘European Green Deal’ (COM(2019) 640),

Amendment 190 #

Paragraph 24

24. Considers it appropriate that pharmaceutical companies submit a joint environmental risk assessment per active substance, including the time necessary for the disappearance of these substances from the environment, based on half-life calculations for radioactive substances, so as to have coherent information, avoid duplication of work and reduce animal testing;

Amendment 191 #

Eleonora EVI, Daniela RONDINELLI

Paragraph 24

24. Considers it appropriate that pharmaceutical companies ~~submit~~perform a joint environmental risk assessment ~~per active substanc~~for 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 192 #

Paragraph 24

24. Considers it appropriate that pharmaceutical companies submit a joint environmental risk assessment per active substance so as to have coherent information, avoid duplication of work and ~~reduce~~make concrete steps towards a complete phase out of animal testing;

Amendment 193 #

Joëlle MÉLIN, Annika BRUNA, Catherine GRISET, Luisa REGIMENTI

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 194 #

Paragraph 24 a (new)

24a. Asks the Commission and the Member States quickly to address the lack of studies on the mutual potentiation of the different molecules and the interaction of natural metabolic degradation products;

Amendment 195 #

Paragraph 25 a (new)

25 a. Calls on the Commission to support research on the assessment of mixture effects, chronic exposition on low dose and antimicrobial resistance development, especially in relation to vulnerable groups of population;

Amendment 196 #

Jessica POLFJÄRD

Paragraph 26

26. Stresses that measures must be based on scientific evidence and calls on all relevant players to ensure that actions taken do not jeopardise access to safe and effective pharmaceutical treatments for human patients and animals; in this regard, supports the Commission’s intention to reduce waste by allowing that medicines be dispensed in quantities better matching needs, whilst ensuring compliance with current traceability legislation, including by optimising the package size, and to explore the possibility to extend expiry dates for medicines to avoid that medicines that can still be safely used are unnecessarily thrown away;

Amendment 197 #

Paragraph 26

26. Stresses that measures must be based on scientific evidence and calls on all relevant players to ensure that actions taken do not jeopardise access to safe and effective pharmaceutical treatments for human patients and animals; in this regard, supports the Commission’s intention to reduce waste by allowing that medicines be dispensed in quantities better matching needs, including by optimising the package size, and to explore the possibility to safely extend expiry dates for medicines to avoid that medicines that can still be safely used are unnecessarily thrown away;

Amendment 198 #

Paragraph 26

26. Stresses that measures must be based ~~on scientific evidenc~~the precautionary principle and calls on all relevant players to ensure that actions taken do not jeopardise access to safe and effective pharmaceutical treatments for human patients and animals; in this regard, supports the Commission’s intention to reduce waste by allowing that medicines be dispensed in quantities better matching needs, including by optimising the package size, and to explore the possibility to extend expiry dates for medicines to avoid that medicines that can still be safely used are unnecessarily thrown away;

Amendment 199 #

Paragraph 26 a (new)

26 a. Calls for an update of the requirements with regard to the environmental risk assessment to ensure a proper assessment of mixture effects and take into account the risk for the development of antimicrobial resistance in the environment;

Amendment 2 #

Citation 1 a (new)

- having regard to Article 191 (2) of the Treaty on the Functioning of the European Union,

Amendment 20 #

Citation 17 a (new)

- having regard to the Commission Communication 'European Green Deal' (COM(2019) 640) of the 11 December 2019,

Amendment 200 #

Paragraph 27

27. Considers that the overall per capita drug consumption should be reduced, without ~~jeopardising patients’ health~~causing difficulties in the access to medicines and not reducing the effectiveness of treatments; is of the opinion that the overall per animal veterinary medicines consumption should also decrease and better alternatives should be found;

Amendment 201 #

Maria SPYRAKI, Vangelis MEIMARAKIS, Elissavet VOZEMBERG-VRIONIDI, Georgios KYRTSOS, Anna-Michelle ASIMAKOPOULOU

Paragraph 27

27. Considers that the overall per capita drug consumption should be reduced, without jeopardising patients’ health; is of the opinion that the number of animals on stock farms and the overall per animal veterinary medicines consumption should also decrease and that intensive stockbreeding should be run down;

Amendment 202 #

Paragraph 27

27. Considers that ~~the overall per capita drug consumption should be reduced, without jeopardising patients’ health~~pharmaceutical consumption should be monitored transparently in order to support and encourage responsible use of medicines based on evidence in order to avoid over- consumption; is of the opinion that the overall per animal veterinary medicines consumption should also decrease;

Amendment 203 #

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 204 #

Christine SCHNEIDER, Alexander BERNHUBER

Paragraph 27

Amendment 205 #

Paragraph 27

Amendment 206 #

Paragraph 27

27. Considers that ~~the overall per capita drug consumption should be reduced, without jeopar~~citizens, carers and healthcare professionals should do a responsible use of mediscin~~g patients’ health; is of the opinion that the overall per animal veterinary medicines~~es, enhancing health literacy and patient empowerment, so that the overall per capita drug consumption shcould ~~also decrease~~be reduced;

Amendment 207 #

Nicolae ŞTEFĂNUȚĂ

Paragraph 27 a (new)

27 a. Calls for measurable targets to be put into place with the aim of reducing overall prescription and consumption of pharmaceuticals both in human and animal veterinary;

Amendment 208 #

Paragraph 27 a (new)

27 a. Is of the opinion that further efforts are needed to decrease the overall per animal veterinary medicines consumption;

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 fields~~in 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 21 #

Citation 26 a (new)

- having regard to the Commission Communication of 11 December 2019 entitled ‘The European Green Deal’ (COM(2019)0640),

Amendment 210 #

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 updat~~evaluate and eventually revise Directive 86/278/EEC no later than by the end of 20201, ~~not least so as to avoid that pharmaceutical residues are spread onto fields~~in order to update quality standards according to the latest scientific evidence to promote true circular economy of carbon and nutrients without risk to human health or the environment;

Amendment 211 #

Paragraph 28

28. Considers that a review of Directive 86/278/EEC on sewage sludge is long overdue; calls on the Commission to evaluate and, if necessary given the results obtained, to make a legislative proposal to review and update Directive 86/278/EEC no later than by the end of 20201, not least so as to avoid that pharmaceutical residues are spread onto fields;

Amendment 212 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN

Paragraph 28 a (new)

28 a. Emphasises that the affordability of water has to be maintained and costly treatment plant upgrades should not be shifted to consumers; therefore takes the view that financing depollution via wastewater charges would only burden citizens and would not provide any incentive to reduce the input of pollutants during the manufacturing procedure;

Amendment 213 #

Paragraph 29

29. Considers that pharmaceutical production plants should pre-treat their wastewater; request in this context that the relevant authorities set monitoring requirements to the industry as well as stricter limits to the concentrations of pharmaceuticals in the wastewater ending up to the municipal WWTPs;

Amendment 214 #

Paragraph 29

29. Considers that pharmaceutical production plants should pre-treat their wastewater in accordance with the principle of preventing environmental threats, especially at source;

Amendment 215 #

Paragraph 29

29. Considers that pharmaceutical production plants should pre-treat their wastewater, according to the Best Available Techniques;

Amendment 216 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN

Paragraph 29

29. Considers that pharmaceutical production plants should pre-treat their wastewater, applying Best Available Techniques;

Amendment 217 #

Paragraph 29

29. Considers that pharmaceutical production plants should pre-treat their wastewater applying Best Available Techniques;

Amendment 218 #

Paragraph 29

29. Considers that pharmaceutical production plants should pre-treat their wastewater applying best available techniques;

Amendment 219 #

Paragraph 30

30. Calls for full enforcement of the existing provisions with regard to take- back schemes for unused medicines and calls on Member States which have not yet set up these provisions to do so;

Amendment 22 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN

Citation 12 b (new)

- having regard to its resolution of 15 January 2020 on the European Green Deal (2019/2956(RSP)),

Amendment 220 #

Paragraph 30

30. Calls for the Member States to implement and fully enforce~~ment of~~ the existing provisions with regard to take- back schemes for unused medicines;

Amendment 221 #

Bartosz ARŁUKOWICZ

Paragraph 30

30. Calls for full enforcement of the existing provisions with regard to take- back schemes for unused medicines and for the widest possible promotion of this type of solution;

Amendment 222 #

Paragraph 30

30. Calls ~~for~~on the Member States to set up and fully enforce~~ment of~~ the existing provisions with regard to take- back schemes for unused medicines;

Amendment 223 #

Paragraph 30

30. Calls ~~for~~on Member States to set up and fully enforce~~ment of the existing~~ provisions with regard to take- back schemes for unused medicines;

Amendment 224 #

Paragraph 30

30. Calls ~~for~~on Member States to set up and fully enforce~~ment of the existing~~ provisions with regard to take- back schemes for unused medicines;

Amendment 225 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Paragraph 30

30. Calls ~~for full enforcement of the existing~~on Member States to set up and enforce provisions with regard to take- back schemes for unused medicines;

Amendment 226 #

Paragraph 30

30. Calls ~~for full enforcement of the existing~~on Member States to set up and enforce provisions with regard to take- back schemes for unused medicines;

Amendment 227 #

Mohammed CHAHIM

Paragraph 31 a (new)

31 a. Calls on the Commission and Member States to fund research and innovation in more advanced water treatment technologies that can improve the removal of pharmaceutical residues and other substances;

Amendment 228 #

Paragraph 31 a (new)

31 a. Recalls that the Commission is due to evaluate the feasibility of setting up an EU-wide active substance-based review system by 28 January 2022 and calls on the Commission to make a legislative proposal to adopt such a review system;

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 23 #

Citation 18 a (new)

- having regard to several Member States' programmes such as the Netherlands Chain approach to reduce pharmaceutical residues in water;

Amendment 230 #

Silvia SARDONE, Aldo PATRICIELLO

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~~through comprehensive monitoring, ~~also with regard to environmental effects~~with the introduction of new indicators where necessary, including environmental impact monitoring, as the current surveillance system (pharmacovigilance) is not adequately and systematically covering the environmental data deficit;

Amendment 231 #

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 not~~and environmental monitoring, in order to ensure adequately and systematic~~ally covering~~ scrutiny of the environmental data deficit;

Amendment 232 #

Maria SPYRAKI, Vangelis MEIMARAKIS, Elissavet VOZEMBERG-VRIONIDI, Georgios KYRTSOS, Anna-Michelle ASIMAKOPOULOU

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 not~~such as environmental monitoring, to adequately and systematically cover~~ing~~ the environmental data deficit;

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 no~~to adequately and systematically cover~~ing~~ the environmental data deficit;

Amendment 234 #

Eleonora EVI, Daniela RONDINELLI, Piernicola PEDICINI

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 235 #

Paragraph 32

32. Is concerned that monitoring of pharmaceuticals in the environment, notably 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 236 #

Eleonora EVI, Daniela RONDINELLI, Piernicola PEDICINI

Paragraph 32

Amendment 237 #

Paragraph 33

33. Calls on the Commission to address the possible impact of pharmaceuticals on the watchlist pursuant to the Water Framework Directive and to assess whether the list should be updated, in particular by including all pharmaceuticals for which an environmental risk has been identified during the authorisation process and by monitoring data in relation to Predicted No Effect Concentration (PNEC) to identify where mitigation measures would be necessary;

Amendment 238 #

Eleonora EVI, Daniela RONDINELLI, Piernicola PEDICINI

Paragraph 33

33. Calls on the Commission to address the possible impact of pharmaceuticals on the watchlist pursuant to the Water Framework Directive and to assess whether the list should be updated; calls on the Commission to propose a soil framework directive, focusing in particular on the concentration of antibiotics in the soil;

Amendment 239 #

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 (EQS) Directive;

Amendment 24 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN

Citation 21 a (new)

- having regard to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) No 1907/2006,

Amendment 240 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Paragraph 33 a (new)

Amendment 241 #

Paragraph 33 a (new)

Amendment 242 #

Paragraph 34

34. Highlights that comprehensive monitoring of antibiotics has been developed in farming; calls on the Commission to also develop a monitoring system in relation to human antibiotics; calls on the Commission to propose a pharmaceuticals monitoring programme, focusing in particular on the concentration of antibiotics in the soil;

Amendment 243 #

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 of exposure to pharmaceuticals and their residues in the environment and on better understanding how pharmaceuticals enter and persist in the environment, including in aquatic and marine ecosystems;

Amendment 244 #

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 of exposure to pharmaceuticals and their residues in the environment and on better understanding how pharmaceuticals enter ~~and persist in~~ the environment and the environmental fate of pharmaceuticals;

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 246 #

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 ecology of exposure to pharmaceuticals and their residues in the environment and on better understanding how pharmaceuticals enter and persist in the environment;

Amendment 247 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Paragraph 35

Amendment 248 #

Paragraph 35 a (new)

35 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 (EQS) Directive;

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 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 250 #

Bartosz ARŁUKOWICZ

Paragraph 36

36. Considers that the methods of analysis to quantify the presence of pharmaceuticals in the environment should be improved, as should the development of technologies for this purpose;

Amendment 251 #

Paragraph 36 a (new)

36 a. Considers that, in order to rectify these knowledge gaps, the European Commission should introduce legally binding measures, such as an international treaty on AMR, to stimulate global knowledge sharing and surveillance;

Amendment 252 #

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 to relevant stakeholders; therefore calls on the Commission and the relevant authorities to set up a secure, centralised database enabling all the actors concerned to have access to the results of the environmental risk assessments of products;

Amendment 253 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Paragraph 37

37. Recalls that pharmaceutical environmental information such as the impact on water, environmental behaviour, degradability and possible cocktail effects plays a key role for risk management and that this type of information should be transparent and made available to relevant stakeholders;

Amendment 254 #

Paragraph 37

Amendment 255 #

Paragraph 37

Amendment 256 #

Paragraph 37

37. Recalls that pharmaceutical environmental information plays a key role for risk management and th~~at this type of information should be made available to~~erefore calls on the Commission to make a legislative proposal to make this type of information available to the public and relevant stakeholders;

Amendment 257 #

Paragraph 37

37. Recalls that pharmaceutical environmental information plays a key role for risk management and that this type of information should be transparent and made available to relevant stakeholders;

Amendment 258 #

Paragraph 39 a (new)

39 a. Calls for the pharmaceutical industry to provide more transparency in supply chains by disclosing origin of drugs and active pharmaceutical ingredients (API) at raw material production stage, to ensure total traceability of all pharmaceutical products;

Amendment 26 #

Citation 22 a (new)

- having regard to the OECD study of November 2019 Pharmaceutical Residues in Freshwater - Hazards and Policy Responses,

Amendment 27 #

Citation 22 a (new)

- having regard to the OECD study of November 2019 Pharmaceutical Residues in Freshwater - Hazards and Policy Responses,

Amendment 28 #

Citation 22 a (new)

- having regard to the OECD study of November 2019 Pharmaceutical Residues in Freshwater - Hazards and Policy Responses,

Amendment 29 #

Citation 23 a (new)

- having regard to the OECD study 'Pharmaceutical Residues in Freshwater - Hazards and Policy Responses' of November 2019,

Amendment 3 #

Citation 1 a (new)

- having regard to Article 191 (2) of the Treaty on the Functioning of the European Union,

Amendment 30 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN

Citation 23 a (new)

- having regard to the OECD study of November 2019 Pharmaceutical Residues in Freshwater - Hazards and Policy Responses,

Amendment 31 #

Citation 12 a (new)

- having regard to the OECD study of November 2019 Pharmaceutical Residues in Freshwater - Hazards and Policy Responses,

Amendment 32 #

Citation 24 a (new)

– having regard to the Commission document entitled 'Towards a sustainable Europe by 2030',

Amendment 33 #

Mairead McGUINNESS

Recital A

A. whereas pharmaceuticals play an essential role in ensuring a high level of ~~public~~human and animal health; whereas there are currently more than 3000 active pharmaceutical ingredients on the European market;

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 35 #

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 as the population ages and grows, and climate change is expected to worsen the pollution of water by pharmaceutical residues as at times of drought concentrations will be higher; whereas the largest source of pharmaceuticals entering the environment is their use and disposal;

Amendment 36 #

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 as the population ages and grows, and climate change will worsen the pollution of water by pharmaceutical residues as at times of drought concentrations will be higher; whereas the largest source of pharmaceuticals entering the environment is their use and disposal;

Amendment 37 #

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 as the population ages and grows, and the impacts of climate change will increasingly and adversely affect both the quantity and the quality of water resources; whereas the largest source of pharmaceuticals entering the environment is their use and disposal;

Amendment 38 #

Recital B

B. whereas the wide use of ~~pharmaceutical~~active substances 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 trend towards increasing consumption of pharmaceuticals for human use is likely to continue as the population gradually ages and grows; whereas the largest source of pharmaceuticals entering the environment is their use and disposal;

Amendment 39 #

Recital B

Amendment 4 #

Citation 1 a (new)

- having regard to Article 191 (2) of the Treaty on the Functioning of the European Union,

Amendment 40 #

Recital B

Amendment 41 #

Recital B

Amendment 42 #

Recital C

C. whereas pharmaceuticals reach the environment through the discharge of effluent from urban wastewater treatment plants, the spreading of animal manure and aquaculture, discharge of effluent from manufacturing plants, the spreading of sewage sludge, grazing livestock, the treatment of pets, improper disposal into landfill of unused pharmaceuticals and contaminated waste and their further dissemination by sometimes heavy rainfall;

Amendment 43 #

Recital C a (new)

Ca. whereas population increase and climate change will have an impact on the quantity of quality of water resources and on water treatment and re-use;

Amendment 44 #

Recital D

D. whereas the excessive and incorrect use of antibiotics, particularly in livestock farming, and more generally poor practices in both human and veterinary medicine, have progressively rendered antimicrobial resistance a massive threat to human and animal health; whereas intensive livestock farming, where large numbers of animals are kept in close proximity to each other, leads to the excessive use of veterinary medicines including antibiotics;

Amendment 45 #

Recital D

D. whereas the ~~excessive and incorrect use of antibiotics, particularly in livestock farming, and more~~inappropriate 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 46 #

Alexander BERNHUBER

Recital D

D. whereas the ~~excessive and~~ incorrect use of antibiotics~~, particularly in livestock farming, and more~~ through generally poor practices in both human and veterinary medicine, ~~have~~particularly in non-EU countries, has progressively rendered antimicrobial resistance a massive threat to human and animal health;

Amendment 47 #

Maria SPYRAKI, Vangelis MEIMARAKIS, Elissavet VOZEMBERG-VRIONIDI, Georgios KYRTSOS, Anna-Michelle ASIMAKOPOULOU

Recital D

D. whereas the ~~excessive and incorrect~~inappropriate use of antibiotics, particularly in livestock farming, and more generally poor practices in both human and veterinary medicine, have progressively rendered antimicrobial resistance a massive threat to human and animal health;

Amendment 48 #

Recital D

D. whereas the ~~excessive and incorrec~~inefficient use of antibiotics, particularly in livestock farming, and more generally poor practices in both human and veterinary medicine, have progressively rendered antimicrobial resistance a massive threat to human and animal health;

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 5 #

Citation 1 a (new)

- having regard to Article 191 (2) of the Treaty on the Functioning of the European Union,

Amendment 50 #

Joëlle MÉLIN, Annika BRUNA, Catherine GRISET, Luisa REGIMENTI

Recital D a (new)

D a. whereas the chemical and/or metabolic stability of certain pharmaceuticals means that up to 90 % of their active substances are released into the environment in their original form after use;

Amendment 51 #

Recital D a (new)

Da. whereas there is a lack of studies on the mutual potentiation of the different molecules and the interaction of their natural metabolic degradation products;

Amendment 52 #

Recital D a (new)

D a. whereas the veterinary antibiotics (VAs) are used in large amounts for therapeutic and prophylactic purposes in addition to their application as growth promoters;

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 54 #

Recital E

Amendment 55 #

Recital E

E. whereas pharmaceuticals authorised for human use 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 56 #

Recital F a (new)

F a. whereas, in its proposed communication, the Commission itself acknowledges the knowledge gaps in terms of concentrations of certain pharmaceuticals in the environment and the resulting levels of risk;

Amendment 57 #

Recital G

G. whereas there is sufficient evidence that action should be taken to reduce the ~~risk~~negative environmental impact from some pharmaceuticals ~~in the environment~~, especially their impact on the development and spread of antimicrobial resistance;

Amendment 58 #

Recital G

G. whereas there is sufficient evidence that action should be taken to reduce the risk from pharmaceuticals in the environment; including the protection of water resources in line with the Water Framework Directive

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 6 #

Maria SPYRAKI, Vangelis MEIMARAKIS, Elissavet VOZEMBERG-VRIONIDI, Georgios KYRTSOS, Anna-Michelle ASIMAKOPOULOU

Citation 1 a (new)

– having regard to Article 11 of the Treaty on the Functioning of the European Union,

Amendment 60 #

Recital G

G. whereas there is sufficient evidence that action should be taken to reduce the ~~risk~~environmental impact from some pharmaceutical~~s in~~ substances, which can pose a risk to the environment;

Amendment 61 #

Recital G

G. whereas there is sufficient evidence that action should be taken to reduce the risk from pharmaceuticals in the environment; such as the impact on drinking water sources;

Amendment 62 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Recital G

G. whereas there is sufficient evidence that action should be taken to reduce the risk from pharmaceuticals in the environment, such as the impact on drinking water sources;

Amendment 63 #

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 some EU Member States such as the Netherlands, Germany and Sweden have already taken action to address the growing presence of pharmaceuticals in the environment;

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 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 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 67 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Recital L

~~L. whereas there is self-regulation to limit the negative impact of pharmaceuticals in the environment, such as iPiE (Intelligent Assessment of Pharmaceuticals in the Environment);~~deleted

Amendment 68 #

Eleonora EVI, Daniela RONDINELLI, Piernicola PEDICINI

Recital L

~~L. whereas there is self-regulation to limit the negative impact of pharmaceuticals in the environment, such as iPiE (Intelligent Assessment of Pharmaceuticals in the Environment);~~deleted

Amendment 69 #

Recital L

L. whereas the~~re is self-regulation to limit the negative impac~~ iPiE (Intelligent Assessment of pPharmaceuticals in the eEnvironment~~, such as iPiE (Intelligent Assessment of Pharmaceuticals in the Environment)~~) Project aims at developing a framework that will provide methodologies to prioritise new and existing medicinal compounds for a comprehensive environmental risk assessment;

Amendment 7 #

Citation 1 b (new)

– having regard to Article 191 of the Treaty on the Functioning of the European Union,

Amendment 70 #

Recital L

L. whereas the~~re 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 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 72 #

Recital L a (new)

La. whereas human and animal health players and professionals, patients, industry, waste management and water treatment operators, etc., have a role to play in reducing the impact of pharmaceutical products on the environment;

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 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 #

Maria SPYRAKI, Vangelis MEIMARAKIS, Elissavet VOZEMBERG-VRIONIDI, Georgios KYRTSOS, Anna-Michelle ASIMAKOPOULOU

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 76 #

Alessandra MORETTI

Subheading 1 a (new)

Ia. whereas any measure regarding the environmental impact of drugs shall consider as the prevailing principle the right of the patients to a swift access to drugs deemed safe and effective with respect to the current risk-benefit assessment criteria;

Amendment 77 #

Paragraph 3

3. ~~Notes however with concern the very~~Takes note of the soft nature of the ~~measure~~recommendations included in the communication~~; considers that legislative measures are needed in addition to non-legislative measures to properly tackle pharmaceutical pollution~~ as these are driven by objectives to pursue, whereas the measures to be taken are of member state competence; considers that effective measures are needed to mitigate the impacts of pharmaceuticals in the environment;

Amendment 78 #

Paragraph 3

3. ~~Notes however with concern the very~~Takes note of the soft nature of the ~~measure~~recommendations included in the communication~~; considers that legislative measures are needed in addition to non-legislative measures to properly tackle pharmaceutical pollution~~ as these are driven by objectives to pursue, whereas the measures to be taken are of Member State competence; considers that effective measures are needed and should be science-driven and risk-based;

Amendment 79 #

Paragraph 3

3. ~~Notes however with concern the very~~Takes note of the soft nature of the measures included in the communication; considers that ~~legisla~~effective measures are needed in ~~addition to non-legislative measures~~order to properly tackle pharmaceutical pollution and mitigate the negative impacts of pharmaceuticals in the environment;

Amendment 8 #

Citation 1 c (new)

– having regard to the 7th Environment Action Programme to 2020 ‘Living well, within the limits of our planet’, as adopted by Decision 1386/2013/EU of the European Parliament and of the Council of 20 November 2013,

Amendment 80 #

Paragraph 3

3. Notes however with concern the very soft nature of the measures included in the communication; considers that legislative measures are needed in addition to non-legislative measures to properly tackle pharmaceutical pollution at European level;

Amendment 81 #

Paragraph 3

3. Notes however with concern the very soft nature of the measures included in the communication; considers that ~~legisla~~effective measures are needed ~~in addition to non-legislative measures~~ to properly tackle pharmaceutical pollution, reflecting member state competences;

Amendment 82 #

Paragraph 4

4. Recalls that any future initiatives in the field of the environmental impact of pharmaceuticals should be ~~science and~~based on the precautionary principle, target driven, a~~s well as~~nd technology neutral, making sure that safety and efficacy still remain key priority features for access for patients to pharmaceutical treatments;

Amendment 83 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Paragraph 5

5. Considers that a holistic approach is needed to tackle pharmaceutical pollution at source, taking into account the entire life cycle of drugs; notes with concern the role that pharmaceuticals play in contributing to antimicrobial resistance when released into the environment via the discharge of animal manure, water pollution or improper disposal; stresses that regulatory actions have to be taken in line with the precautionary principle and the control at source principle; highlights that the polluter pays principle should apply, primarily covering the manufacturing process, but also incentivising better prescription practices and consumer behaviour;

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 appl~~y, primarily covering the manufacturing process, but~~ied, covering all the stages of the life cycle, while also incentivising better prescription practices and responsible consumer behaviour;

Amendment 85 #

Paragraph 5

5. Considers that a holistic approach ~~is needed to tackle pharmaceutical pollution~~, including all the actors concerned, is needed to tackle the negative impact of pharmaceutical products in the environment, taking into account the entire life cycle of drugs; stresses that regulatory actions have to be taken in line with the precautionary principle; highlights that the polluter pays principle should apply~~, primarily covering~~ at all stages of the life cycle of pharmaceutical products, covering, primarily but not exclusively, the manufacturing process, but also incentivising better prescription practices and consumer behaviour;

Amendment 86 #

Paragraph 5

5. Considers that a ~~holistic~~multistakeholder approach is needed to tackle pharmaceutical pollution, taking into account the entire life cycle of ~~drug~~medicines; 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 87 #

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 line with~~, in order to ensure the effectiveness of the regulatory actions being adopted, it is vital that they are adopted in line with the prevention principle and the precautionary principle; highlights, furthermore, that the polluter pays principle should apply, primarily covering the manufacturing process, but also incentivising better prescription practices and consumer behaviour;

Amendment 88 #

Maria SPYRAKI, Vangelis MEIMARAKIS, Elissavet VOZEMBERG-VRIONIDI, Georgios KYRTSOS, Anna-Michelle ASIMAKOPOULOU

Paragraph 5

5. Considers that a holistic approach is needed to tackle pharmaceutical pollution at source, taking into account the entire life cycle of drugs; stresses that regulatory actions have to be taken in line with the precautionary principle and the control at source principle; highlights that the polluter pays principle should apply, primarily covering ~~the manufacturing process, but also incentivising better prescription practices and consumer behaviour~~entire lifecycle of pharmaceuticals from the manufacturing process to prescription, and from use to disposal and waste treatment;

Amendment 89 #

Paragraph 5

5. Considers that a ~~holistic~~multi-stakeholder approach is needed to tackle ~~pharmaceutical pollution~~the impacts of pharmaceuticals in the environment, taking into account the entire life cycle of drugs; 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 by designing and implementing a policy mix that combines source-directed, use-oriented and end-of-pipe-measures using a combination of voluntary, economic and regulatory instruments; and also incentiviszing better prescription practices and consumer behaviour;

Amendment 9 #

Citation 8 a (new)

- having regard to the successive annual European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) reports (since 2011),

Amendment 90 #

Paragraph 5

5. Considers that a ~~holistic approach is needed to tackle pharmaceutical pollution~~multi stakeholder and coordinated approach is needed to tackle the negative impacts of pharmaceuticals in the environment, taking into account the entire life cycle of drugs; 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 behaviourmedicines by designing and implementing a policy mix that combines source- directed, use-oriented and end-of-pipe- measures using a combination of voluntary, economic and regulatory instruments;

Amendment 91 #

Paragraph 5 a (new)

5a. Considers it necessary to organise, in collaboration with the Member States, campaigns to inform and educate the public about the dangers of over- consumption of non-prescribed medicines; draws attention to the increase in the number of supermarket and online sales of medicines without medical recommendation and to the danger of media advertising for such points of sale outside of pharmacies or suitably accredited establishments;

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 93 #

Paragraph 6

6. Highlights that emissions of pharmaceuticals into the environment may not only harm ecosystems and wildlife, but may also undermine the effectiveness of these same pharmaceuticals, as they can cause the emergence of antibiotic resistance;

Amendment 94 #

Paragraph 6 a (new)

6 a. Recalls that pharmaceuticals have diverse impacts on aquatic and marine ecosystems but also wildlife, including behavioural changes, fecundity reduction, size modification or development of sexual and reproductive abnormalities; calls therefore on the Commission to integrate concrete measures taking into account the cumulative effects of pharmaceutical products contamination on aquatic and marine species;

Amendment 95 #

Paragraph 7

7. Recalls that studies have shown that pharmaceutical products are especially present in water bodies, and that they are ineffectively filtered by wastewater treatment plants currently cannot effectively filter out all pharmaceutical products, due to the intrinsically different chemical properties of the relevant substances;

Amendment 96 #

Paragraph 7

7. Recalls that studies have shown that pharmaceutical products are especially present in water bodies, and that they are ineffectively filtered by wastewater treatment plants; highlights that contamination of freshwater and rivers basins naturally lead to contamination of the ocean on a global scale;

Amendment 97 #

Günther SIDL, Tiemo WÖLKEN, Nicolás GONZÁLEZ CASARES, Mohammed CHAHIM, César LUENA, Eric ANDRIEU, Biljana BORZAN, Demetris PAPADAKIS

Paragraph 7

7. Recalls that studies have shown that pharmaceutical products are especially present in water bodies, and that ~~they are ineffectively filtered by wastewater treatment plants~~wastewater treatment plants currently cannot effectively filter out all pharmaceutical products, due to the intrinsically different chemical properties of the relevant substance;

Amendment 98 #

Paragraph 7

7. Recalls that studies have shown that pharmaceutical products are especially present in water bodies, and that they are ineffectively filtered by wastewater treatment plants, requiring periodic adaptation of purification processes in line with the new products and technologies on the market;

Amendment 99 #