Annexes to COM(2019)128 - EU Strategic Approach to Pharmaceuticals in the Environment - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2019)128 - EU Strategic Approach to Pharmaceuticals in the Environment. |
|---|---|
| document | COM(2019)128  |
| date | March 11, 2019 |
•Engage directly with the pharmaceutical industry on its potential contribution to meeting the objectives of the approach, among other things to explore how extended producer responsibility could play a role in supporting action to improve the efficacy of water treatment;
•Under the Water Framework Directive, consider specific pharmaceuticals, and groups of pharmaceuticals with similar effects, in the work supporting the regular review of the list of substances posing a risk at Union level, and work with Member States on environmental quality standards for pharmaceuticals posing a risk at national level;
•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;
•Discuss, with the relevant Member State authorities, the possibility of using procurement policy to encourage greener pharmaceutical design and manufacturing;
•Encourage, through dialogue and cooperation, as part of the Union’s external policies, action in third countries where pharmaceutical emissions from manufacturing and other sources are suspected of contributing to the global spread of AMR.
5.3 Improve environmental risk assessment and its review
It’s important that risk assessment and guidance development are coordinated and involve all relevant expertise. Data sharing and improved access to data could facilitate better risk management, as could retrospective environmental risk assessment for several products already on the market, and earlier availability of the risk assessment data for human medicinal products. The initiative in all these areas can best be taken at Union level.
The Commission will:
•In collaboration with the European Medicines Agency and Member States:
-Seek to improve the level of environmental expertise in the Committees and networks involved in the environmental risk assessment of medicinal products;
-Consider developing guidance on the environmental risk assessment of medicinal products for use in aquaculture including, where appropriate, recommendations for risk management measures;
-Examine how to improve public access to the main environmental risk assessment results and relevant toxicological thresholds for medicinal products while respecting data-protection rules;
-Emphasise to applicants the importance of submitting a completed assessment by the time of the authorisation for marketing human medicinal products, so that adequate risk management measures can be established and published;
•Pursuant to the newly adopted Regulation on veterinary medicinal products, report on the feasibility of setting up an EU-wide review system based on active pharmaceutical ingredients, or similar, to support the environmental risk assessment of veterinary medicinal products at Union level;
•Initiate a systematic catching-up procedure for veterinary medicinal products without an (adequate) environmental risk assessment, as provided for in the Regulation on veterinary medicinal products, and take stock of the results of research under the Innovative Medicines Initiative 58 in relation to human medicinal products;
•Consider the findings of recent REACH evaluations and the ongoing Fitness Check of other Union chemicals legislation as regards links with the medicinal products legislation in relation to environmental protection.
5.4 Reduce wastage and improve the management of waste
Less wastage of pharmaceuticals and proper disposal would reduce the risk to the environment. More advanced waste water treatment technology may be appropriate at some locations. Source control of the diffuse emissions from livestock farming appears particularly necessary.
The Commission will:
•In collaboration with Member States and the European Medicines Agency:
-explore the possibility of reducing waste by optimising the package size of pharmaceuticals so that medicines can be dispensed in quantities better matching needs, and by safely extending use-by (expiry) dates so that fewer medicines that are still usable have to be thrown away;
-facilitate the exchange of best practices among healthcare professionals on the environmentally safe disposal of medicinal products and clinical waste, and the collection of pharmaceutical residues as appropriate ;
•Assess the implementation of collection schemes for unused pharmaceuticals and consider how their availability and functioning could be improved, how to increase public awareness of the importance of using them, and how extended producer responsibility could play a role in reducing inappropriate disposal;
•In relation to urban waste water treatment:
-Use Union programmes to invest in technologies to improve the efficiency of removal of pharmaceuticals (and antimicrobial resistance genes);
-As part of the study supporting the evaluation of the existing urban waste water treatment legislation, assess whether it sufficiently controls pharmaceutical emissions and investigate the feasibility of upgrading selected urban waste water treatment plants to more advanced treatment technologies;
•Assess the possibility of working with Member States on improving their Codes of Good Agricultural Practice to cover also the management of contaminants including pharmaceuticals in livestock manure;
•When the Industrial Emissions Directive is next evaluated, assess whether it should address intensive dairy farming 59 .
5.5 Expand environmental monitoring
The collection and management of environmental data is to a large extent based on Union legislation and/or supported by Union funding. Knowing more about the concentrations of pharmaceuticals in the environment would allow environmental risk assessments to be improved and measures to be more focused, especially if monitoring could be extended to better cover certain parts of the environment, where necessary involving cooperation with stakeholders.
The Commission will:
•Consider additional potentially relevant pharmaceuticals, such as cytotoxic pharmaceuticals and X-ray contrast media, in the work supporting the review of the surface water Watch List under the Water Framework Directive, as well as the feasibility of monitoring antimicrobial resistant microorganisms and antimicrobial resistance genes;
•Support research on monitoring individual substances and mixtures of substances in fresh and marine waters, soils, sediments, and wildlife, using conventional analytical and complementary techniques;
•Explore with stakeholders, including water treatment companies/authorities, the gathering of relevant data in effluents from potential hotspots; the development of online monitoring, and the sharing of data via the Information Platform for Chemical Monitoring 60 , to inform analyses of sources and potential exposure;
•Include antimicrobials and possibly antimicrobial resistance genes in the next phase of the European Commission’s LUCAS soil survey 61 .
5.6 Fill other knowledge gaps
While the above actions include some research, our ability to manage the risk could benefit from research in other areas.
The Commission will thus consider supporting further research, also under the Union's next Multi-annual Financial Framework, into:
•The eco-toxicity and environmental fate of pharmaceuticals, in particular those not yet subject to environmental risk assessment;
•The links between the presence of antimicrobials in the environment (if possible also the entry and natural presence of antimicrobial resistance genes) and the development and spread of antimicrobial resistance;
•The possible effects on humans of (chronic) exposure to low levels of pharmaceuticals via the environment, taking account of the potential for combined effects from multiple substances, and of vulnerable sub-populations;
•Cost-effective methods for reducing the presence of pharmaceuticals including antimicrobials in slurry, manure and sewage sludge to enable their use in the circular economy.
6 Conclusions
This Communication sets out a strategic approach to the risks from pharmaceuticals in the environment, and thus meets a legal obligation to propose an approach addressing the pollution of water by pharmaceuticals. It also contributes to tackling the problem of antimicrobial resistance and honours commitments made at international level, where, as a strong global actor, the Union can encourage wide cooperation.
Although it is clear that treating many diseases in animals and humans relies on effective pharmaceuticals, and that some substantial knowledge gaps remain to be filled, there is sufficient evidence that action should be taken to reduce the risk from pharmaceuticals in the environment. This requires the involvement of all relevant stakeholders along the entire life cycle, including Member State competent authorities, the pharmaceutical industry, medical and veterinary professionals, patients, farmers and the water industry, with the shared goal of building a more sustainable, resource-efficient and circular economy.
While leading on actions within its area of competence, the Commission will also encourage others to lead, including by facilitating the exchange of best practices.
The Communication focuses on actions that are starting, will be initiated and, in some cases, completed by 2020.
The Commission will then take stock of progress made and decide on further steps, taking into account the outcomes of ongoing evaluations of the water legislation and relevant research.
(1)
The term "pharmaceuticals" is used here to refer to human or veterinary medicinal products. Usually, the active pharmaceutical ingredients (APIs) are the substances of concern, but also their metabolites and degradation products may be relevant, as well as some ingredients (excipients) other than the active substance and the packaging material.
(2)
COM (2008) 666 Final: Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on Safe, Innovative and Accessible Medicines: A Renewed Vision for the Pharmaceutical Sector.
(3)
Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products, OJ L 348, 31.12.2010, p. 1; Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use, OJ L 348, 31.12.2010, p. 74
(4)
https://ec.europa.eu/health/sites/health/files/scientific_committees/scheer/docs/scheer_s_002.pdf
(5)
Directive 2008/105/EC, OJ L348, 24.12.2008, p.84
(6)
Directive 2013/39/EU, OJ L 226, 24.8.2013, p.1
(7)
Recital 6 of Directive 2010/84/EU, OJ L 348, 31.12.2010, p.74
(8)
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(9)
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(10)
COM/2017/0339 final: Communication from the Commission to the Council and the European Parliament: A European One Health Action Plan against Antimicrobial Resistance (AMR) https://eur-lex.europa.eu/legal-content/GA/TXT/?uri=CELEX:52017DC0339
(11)
BIO Intelligence Service 2013 Study on the environmental risks of medicinal products. https://ec.europa.eu/health/sites/health/files/files/environment/study_environment.pdf ; Report of the 2014 Commission workshop on pharmaceuticals in the environment https://circabc.europa.eu/w/browse/5d532921-1e1f-48f5-b0e0-3057798423ca and http://ec.europa.eu/environment/water/water-dangersub/index.htm#strategic
(12)
http://ec.europa.eu/environment/water/water-dangersub/index.htm#strategic
(13)
http://ec.europa.eu/environment/water/water-dangersub/index.htm#strategic
(14)
http://ec.europa.eu/environment/water/water-drink/pdf/20171215_EC_project_report_final_corrected.pdf
(15)
Metabolites (conversion products) may have lower biological activity (see case studies in http://ec.europa.eu/health/human-use/environment-medicines/index_en.htm ) but may, e.g. if conjugated, be converted back to the parent pharmaceutical during sewage treatment, or have similar biological activity.
(16)
Niemuth NJ and Klaper RD 2015. Chemosphere 135: 38-45; Fent K 2015. Environ Int 84:115-30; Matthiessen P and Sumpter JP 1998. EXS. 86:319-35
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Verdú JR et al. 2015. Scientific Reports 5: 13912
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LIFE11 NAT/BE/001060, http://www.lifeprairiesbocageres.eu/fileadmin/Life/Prairies_bocageres/brochure_LPB_antiparasitaires_final.pdf
(23)
http://ec.europa.eu/environment/water/water-drink/pdf/20171215_EC_project_report_final_corrected.pdf
(24)
Concentrations typically several orders of magnitude lower than the minimum therapeutic dose
(25)
http://apps.who.int/iris/bitstream/10665/44630/1/9789241502085_eng.pdf?ua=1
(26)
COM (2017) 753 final: Proposal for a Directive of the European Parliament and of the Council on the quality of water intended for human consumption (recast)
(27)
COM (2011) 748 final: Communication from the Commission to the European Parliament and the Council on an Action Plan Against the Rising Threats from Antimicrobial Resistance
(28)
e.g. ECDC/EFSA/EMA, 2015. EFSA Journal 2015;13(1):4006, 114 pp. doi:10.2903/j.efsa.2015.4006; Finley RL et al. 2013. Clinical Infectious Diseases 57(5): 704-710
(29)
See footnote 10
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Knappe, Poseidon, Endetech, Pharmas, Cytothreat, Radar, Demeau, DePharm, Pharm AD, Solutions
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(32)
Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy, OJ L327, 22.12.2000, p.1
(33)
Commission Implementing Decision (EU) 2018/840 of 5 June 2018 establishing a watch list of substances for Union-wide monitoring in the field of water policy pursuant to Directive 2008/105/EC of the European Parliament and of the Council and repealing Commission Implementing Decision (EU) 2015/495, OJ L141, 7.6.2018, p.9
(34)
Groundwater Watch List: Pharmaceuticals Pilot Study 2016. https://circabc.europa.eu/w/browse/a1e23792-6ecd-4b34-b86c-dcb6f1c7ad1c
(35)
http://i-pie.org/
(36)
https://www.phar-in.eu/wp-content/uploads/2014/05/Figures_2014_Final.pdf ; https://www.efpia.eu/media/361960/efpia-pharmafigures2018_v07-hq.pdf
(37)
OECD (2019), "Pharmaceutical market", OECD Health Statistics (base de données), https://doi.org/10.1787/data-00545-en (données extraites le 07 January 2019)
(38)
https://www.ema.europa.eu/en/veterinary-regulatory/overview/antimicrobial-resistance-veterinary-medicine
(39)
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(40)
https://www.ema.europa.eu/documents/report/sales-veterinary-antimicrobial-agents-30-european-countries-2016-trends-2010-2016-eighth-esvac_en.pdf
(41)
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC , OJ L 4, 7.1.2019, p.43, and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p.67, as amended.
(42)
Regulation (EU) 2019/6 as in previous footnote
(43)
BIO Intelligence Service 2013 Study (see footnote 11): Chapter 8
(44)
COM(2018) 734 final: Communication from the Commission to the European Parliament, the Council, the European Economic And Social Committee and the Committee of the Regions: “Towards a comprehensive European Union framework on endocrine disruptors”
(45)
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006, OJ L 353, 31.12.2008, p.1; Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, OJ L 396, 30.12.2006, p.1
(46)
Restriction provisions in REACH are those which allow the manufacture, use or placing on the market of substances to be made subject to conditions or be prohibited to address identified risks not adequately controlled; in practice, these provisions have not been applied in relation to medicinal products.
(47)
Some authorisations have been granted.
(48)
http://ec.europa.eu/environment/chemicals/reach/pdf/studies_review2012/report_study8.pdf
(49)
The Netherlands Chain approach to reduce pharmaceutical residues in water. 2018. Abstract for OECD workshop on contaminants.
(50)
https://www.fass.se/LIF/
(51)
E.g. EP Intergroup CCBSD event 29 November 2017 http://ebcd.org/event/pharmaceuticals-in-the-environment/
(52)
https://www.parlament.ch/centers/eparl/curia/2012/20123090/Bericht%20BR%20D.pdf
(53)
SAICM http://www.saicm.org/EmergingPolicyIssues/Pharmaceuticalnbsp;Pollutants/tabid/5477/language/en-US/Default.aspx
(54)
The Baltic Marine Environment Protection Commission: http://www.helcom.fi/news/Pages/Pharmaceuticals-in-Baltic-waters--new-status-report-by-UNESCO-and-HELCOM.aspx
(55)
http://www.oecd.org/water/oecdworkshoponmanagingcontaminantsofemergingconcerninsurfacewaters.htm
(56)
Eco-pharmaco-stewardship https://www.efpia.eu/media/25628/eps-a-holistic-environmental-risk-management-program.pdf and https://www.efpia.eu/media/288586/pie-brochure.pdf
(57)
Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC , OJ L 4, 7.1.2019, p.43
(58)
For example as regards the potential application of relevant prioritisation principles identified in the ongoing Innovative Medicines Initiative project on Intelligence-led Assessment of Pharmaceuticals in the Environment ( http://i-pie.org/ ), due to be completed by the end of 2019.
(59)
At present, only intensive pig and poultry farming are covered ( http://eippcb.jrc.ec.europa.eu/reference/irpp.html ).
(60)
https://ipchem.jrc.ec.europa.eu/RDSIdiscovery/ipchem/index.html
(61)
https://esdac.jrc.ec.europa.eu/projects/lucas