European Initiatives on Pharmaceuticals in the Environment Helen Clayton, ENV C1 Water European Commission IWA Sweden Conference 2016 Water and Pharmaceuticals insights and perspectives for health and environment 12-13 April 2016, Uppsala
Contents Strategic Approach to Pharmaceuticals in the Environment (PIE) Background Current state of play Study including public consultation Related ongoing European initiatives in the context of: The water legislation The chemicals legislation The medicinal products legislation Research Other issues 2
Strategic approach to PIE - Background & legal basis Article 8c of Directive 2008/105/EC on Environmental Quality Standards in the field of water policy as amended by Directive 2013/39/EU COM to develop, as far as possible by Sept 2015, a strategic approach to pollution of water* by pharmaceutical substances. * - effectively "environment" COM to propose, where appropriate, by Sept 2017, measures to be taken at Union and/or MS level, to address the possible environmental impacts of pharmaceutical substances, with a view to reducing discharges, emissions and losses into the aquatic environment, taking into account public health needs and the cost-effectiveness** of the measures proposed. ** = full impact assessment 3
Strategic approach to PIE - State of play Roadmap being revised Final internal approval required before it can be published Brief public consultation before the summer? Supporting study begun in December 2015 Strategic approach to be adopted in first half of 2017? 4
Strategic approach to PIE - Supporting study Study underway 12 month contract began December 2015; due to report December 2016 Tasks include: update on scale of the problem, including info re uncertainties (to complement BIO IS study published in June 2014) consideration of options (legislative and non-legislative) including preliminary assessment of pros/cons (building on BIO IS study and September 2014 COM workshop) public consultation (summer 2016?) and analysis of consultation inputs 5
Related ongoing initiatives in the context of the water legislation - I Watch List (solution to "Catch 22") Surface water watch list adopted March 2015, including E2, EE2, Diclofenac, and three macrolide antibiotics Monitoring underway Data and the list to be reviewed in early 2017 Review of the WFD priority substances list Monitoring and modelling-based prioritisation approaches being used, including consideration of data on pharmaceuticals Being led by JRC with input from MS and stakeholders Proposal possible early 2018 6
Watch-list and ad-hoc monitoring Ongoing routine WFD monitoring Priority substances selection/ review Note: WFD considers risks to and via the aquatic environment, therefore exposure is compared with PNEC or EQS for most sensitive receptor e.g. aquatic organism, predator, humans (via consumption of water or fishery products) Review of measures + implementa tion of new measures Routine WFD monitoring Feedback to WFD and other legislation Is EQS exceeded?
Related ongoing initiatives in the context of the water legislation - II Watch List for Groundwater Voluntary watch list, introduced by amendment to Groundwater Directive Pharmaceuticals case-study being completed Water Reuse initiative Guidance on water reuse due to be finalised this year Possible Regulation on water-reuse standards 8
Related ongoing initiatives in the context of the water legislation - III Review of the Drinking Water Directive Supporting study currently underway Includes consideration of the list of parameters, in collaboration with the WHO Revision of the GES Decision under MSFD Closer links with WFD chemical and ecological status? 9
Related ongoing initiatives in the context of the chemicals legislation IPCheM https://ipchem.jrc.ec.europa.eu/media/pdf/ipch EM-Flyer_18.06.2014_final.pdf Community Strategy on Endocrine Disruptors Fitness Check of Chemicals Legislation Supported by studies on the benefits of the chemicals legislation (including benefits indicators etc) Mixtures follow-up of Council Conclusions Non-toxic environment strategy 10
Related ongoing initiatives in the context of the medicinal products legislation Veterinary Medicinal Products Regulation currently being negotiated ERA Guidelines for human medicinal products consideration of possible need for revision Action Plan on the Rising Threat from Antimicrobial Resistance regular review 11
EU-(co)funded research projects KNAPPE NORMAN (-> NORMAN Association) PHARMAS Cytothreat PILLS No-PILLS TAPES Modelkey EDA-Emerge SOLUTIONS ipie 12
Other issues WFD review 2019. Is a more holistic approach to water pollution, e.g. taking account of mixtures, use of effect-based tools, already possible? Water treatment methods development of better technologies (JRC interest; Innovation Partnership on Water) Other policy areas relevant to the lifecycle of pharmaceuticals Development/authorisation/production Consumption/use Disposal 13
Let's aim to make all water the best water in the world! helen.clayton@ec.europa.eu 14