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4.2         EU strategic approach to pharmaceuticals in the environment

The 2013 Priority Substances Directive required the European Commission to develop a strategic approach to pollution of water by pharmaceutical substances, with expectation that the strategy would be developed by 2015. (The strategic approach was scheduled for adoption by the Commission in 2018, but at the time of writing no date for adoption has been set.) Cutting across health and environment legislative policies, pharmaceuticals in the environment is a “headline grabbing” topic where balancing the needs of different stakeholders is challenging and essential. Building understanding and developing effective, proportionate actions across different areas requires resources and high level commitment. While the EU level approach is being developed, Member States continue to develop actions relevant to their competence.

4.2.1.     The issue
Pharmaceuticals are used to improve the health of both humans and animals. Once taken, the medicine and its breakdown products (“metabolites”) are excreted in urine and fæces. Where there is urban waste water treatment, sewage is treated and the medicine and its breakdown products may be broken down further. Substances remaining may then be discharged into the environment, in effluent or as sewage sludge applied to land. 

EU medical products regulation (EC, 2004) requires environmental risk assessment for veterinary medicines, but that is not currently required for human medicines.  This in part reflects the tensions in priorities between the benefits of health care and risks to drinking water resources and ecosystems. As understanding of the potential effects of very low levels of pollutants has increased, so has concern about release of biologically active molecules into the environment.

4.2.2.     Member State responses
There was collaboration between Member States and the Commission well in advance of the Priority Substances Directive (EU, 2013b). Two-way communication – advising of concerns and learning about them – is part of a well-functioning, high level process. Possible EQS values were prepared, and although these did not become legally binding, they are used to indicate whether there may be concentrations of concern.

To differing extents, Member States were investigating concentrations of medicines in their surface waters. For example, further to investigations into effects of a contraceptive pill ingredient, EE2, on fish, work in the UK considered waste water treatment and socioeconomic impacts of pharmaceuticals in the environment (Environment Agency, 2008; Gardner et al, 2013; Defra, 2015). In Germany, between 2013–2015, concentrations of several pharmaceuticals were compared with possible EQS, revealing isolated cases where EQS were exceeded for carbamazepine (an anti-epileptic), clarithromycin, the contraceptives E2 and EE2, and more frequently in the cases of diclofenac and ibuprofen (Figure 3.2).

Figure 4.2      Pharmaceuticals in German Surface Waters: Comparison of annual concentration means at surveillance monitoring sites with possible  environmental quality standards

 

 Source: Waters in Germany – Status and Assessment. Federal Environment Agency, 2017. https://www.umweltbundesamt.de/sites/default/files/medien/377/publikationen/171018_uba_gewasserdtl_engl_bf.pdf

Previous comments

  • sommelin (Linda Sommer) 26 Sep 2018 11:33:28

    DE-UBA IV 2.2:

    Last paragraph:

    Please emphasise the need for a european strategy in the last paragraph, by e.g.

    'While the EU level approach is being developed and urgently needed,…'

     

  • sommelin (Linda Sommer) 26 Sep 2018 11:37:38

    DE-UBA IV 2.2:

    “ EU medical products regulation (EC, 2004) requires environmental risk assessment for veterinary medicines, but that is not currently required for human medicines.'

    This statement is not correct. Could it be that the envrironmental risk assessment (which ist required for both veterinary and human) was confused with the Risk-Benefits-Analysis?

    Please change to:“EU medical products regulation (EC,2004) requires environmental risk assessment for human and veterinary medicines. However, environmental risks are only taken into account within the risk-benefit-analyses for veterinary medicines.”

  • sommelin (Linda Sommer) 26 Sep 2018 11:38:28

    DE-UBA:

    Figure 4.2:

    - figure legend is in German

    - figure title it should be proposed instead of possible

     

  • Bertrand Vallet (invited by Caroline Whalley) 28 Sep 2018 11:36:38

    EurEau

    "This in part reflects the tensions in priorities between the benefits of health care and risks to drinking water resources and ecosystems"

    Risks are not only for drinking water resources but for water resources in general. The effects of pharmaceutical through drinking water are a research topic and should not be claimed as such in the report.

    We ask that the word "drinking" is removed, not to focus the attention only on drinking water.

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