1. Health and Food Safety EU strategy for Pharmaceuticals in the Environment Patrizia Tosetti DG SANTE European Commission China/EU Pharmaceutical Industry Forum 5 April 2016

2. Health and Food Safety Background: where did we start?  Communication from the Commission (2008): An emerging environmental problem & and emerging public health concern  Adoption of EU legislation on pharmacovigilance (2010) Directive 2010/84/EU; Regulation (EU) No 1235/2010 Member States to consider monitoring and evaluation of the risks Commission to produce a report  Communication COM (2011) 748 on an Action plan against the rising threats from Antimicrobial Resistance 2

3. Health and Food Safety  Directive 2001/82/EC – Community code relating to veterinary medicinal products – amended by Directive 2004/28/EC  Directive 2001/83/EC – Community code relating to medicinal products for human use – amended by Directive 2004/27/EC environmental risk assessments (ERA) to be conducted; Member States to ensure that appropriate collection systems are in place for unused medicinal products The summary of product characteristics has to include special precautions for disposal of a used medicinal product or derived waste materials, if appropriate. 3 "Core" medicinal products legislation

4. Health and Food Safety  The BIO IS study  Global study: scale of the problem, causes, legislative and non-legislative options  Contracted by DG SANTE  Approach: whole life cycle of pharmaceuticals (Human & Veterinary medicines)  Gather scientific evidence to inform policy decisions  Published in June 2014  Stakeholder workshop held in Sept 2014 to discuss options Study on the environmental risks of medicinal products 4

5. Health and Food Safety Outline of the study  How do medicinal products enter the environment?  Which molecules are found in the environment and how do they behave?  Environmental hazards  Human exposure through the environment and possible impacts  Factors of influence  Possible solutions 5

6. Health and Food Safety Possible solutions are extremely diverse (I)  Some examples: Improve knowledge by collection of data Creation of database with existing environmental studies Review of ERA guidelines Prioritisation of substances Inclusion of ERA in risk-benefit analysis of medicines for human use Monograph system 6

7. Health and Food Safety Possible solutions are extremely diverse (II)  More examples: Control of emissions by production sites, hospitals Inclusion in GMP Improvement of waste water treatment Increased collection of unused medicinal products Inclusion in pharmacovigilance – Eco-pharmacovigilance 7

8. Health and Food Safety Veterinary medicines: draft Regulation  In the draft Regulation: ERA remains compulsory for all veterinary medicines (including generics) Old products: environmental re-assessment (harmonisation SPCs) Collection systems Pharmacovigilance: detecting risks to the environment 8

9. Health and Food Safety EU water legislation  Regular review of the Priority Substances List under the Water Framework Directive (WFD) 2000/60/EC  2012 COM proposal to include 3 pharmaceuticals (alpha-ethinyl estradiol, beta-estradiol, diclofenac), with environmental quality standards (EQS), in the list of priority substances in the EQS (Priority Substances) Directive 2008/105/EC  Member States should already identify pollutants of national concern, which could include pharmaceuticals. 9

10. Health and Food Safety Priority substances proposal 2012: Outcome of the negotiations  Much discussion regarding monitoring data and regarding costs and benefits, in particular the cost of water treatment  The 3 pharmaceuticals – not included in the list  Instead: The 3 pharmaceuticals to be included in the first watch list – to gather data for the purpose of facilitating the determination of appropriate measures to address the risk posed by those substances Specific provisions (Article 8c) requiring the Commission to develop a strategic approach to the pollution of water by pharmaceuticals 10

11. Health and Food Safety Article 8c of EQS Directive: Legal basis for the strategic approach (I)  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. * - will be broader, i.e. environment 11

12. Health and Food Safety Article 8c of EQS Directive: Legal basis for the strategic approach (II)  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 12

13. Health and Food Safety Where are we? (I)  Following new Commission procedures (Better Regulation)  First Watch List adopted March 2015 (COM Implementing Decision (EU) 2015/495) including the three pharmaceuticals plus three macrolide antibiotics (and other substances) – monitoring for at least one year. Consideration in new review of priority substances list.  Roadmap for strategic approach awaiting final validation 13

14. Health and Food Safety Where are we? (II)  Study launched to gather additional information to complement BIO- IS report and other sources  Public consultation in second half of 2016; industry and other stakeholders will be invited to give further input  Timeline for adoption of strategic approach likely to be delayed by about 18 months  Report of Sept 2014 workshop will soon be available 14

15. Health and Food Safety A word on anti-microbial resistance… 15

16. Health and Food Safety Antimicrobial Resistance (AMR) (I)  The Commission's 2011 Action Plan against AMR contains 12 actions for implementation by EU Member States  The Commission published a Road Map with the operational objectivesand the deadlines of the 12 Actions of the Action Plan.  The Roadmap includes the development of the strategic approach to pollution of water by pharmaceutical substance.  The strategic approach will address, inter alia, the need for additional information on the presence of antibiotics in the environment, their potentially harmful levels and possible contribution to the development and maintenance of AMR. 16

17. Health and Food Safety Antimicrobial Resistance (AMR) (II)  The Commission is currently carrying out an external evaluation of the AMR action plan, which will inform further policy developments to be considered during 2016 and beyond  Preliminary conclusions of this evaluation were presented in February at the Ministerial conference on AMR in Amsterdam. Final report is expected in April 2016.  The Commission plans to produce a staff working document on the outcome of the evaluation (second half of 2016).  The Commission intends to continue working closely with EMA and the AMR network on strategic objectives in combatting AMR. 17

18. Health and Food Safety Thank you! Questions? sante-veterinary-medicines@ec.europa.eu sante-veterinary-medicines@ec.europa.eu 18