Commission’s Communication A renewed vision for the pharmaceutical sector

Commission’s CommunicationA renewed vision for the pharmaceutical sector Peter Korytár European Commission – DG Environment Uppsala, 11 November 2009

Europe has been losing ground in pharmaceutical innovation Shortcomings in the availability of medicines The sector becoming more and more globalised Scientific breakthroughs revolutionize the way medicines are developed and prescribed Europe’s challenges

To ensure that European citizens can increasingly benefit from a competitive industry that generates safe, innovative and accessible medicines The Commission’s vision

Making further progress towards a single and sustainable market in pharmaceuticals Taking on the opportunities and challenges of globalization Making science deliver for European patients Commission Communication COM (2008) 666

Better access to medicines for European patients Better regulation for a more competitive industry Safer medicines for better informed citizens: Improving safety Empowering patients Addressing the environmental impact Making further progress towards a single and sustainable market in pharmaceuticals

Tackling illegal medicinal products Preparing to combat pandemics Strengthening international cooperation Promoting global harmonisation Taking on the opportunities and challenges of globalization

Supporting pharmaceutical research Realising the promises of regenerative medicine Towards more personalised medicines Making science deliver for European patients

Measures to reduce the potentially harmful impacts of pharmaceuticals on the European environment and public health should be proposed Addressing the environmental impact

FP5 ERAVMIS - Environmental Risk Assessment of Veterinary Medicines in Sludge REMPHARMAWATER - Ecotoxicological Assessments and Removal Technologies for Pharmaceuticals in Wastewater POSEIDON - Assessment of Technologies for the Removal of Pharmaceuticals and Personal Care Products in Sewage and Drinking Water Facilities to Improve the Indirect Potable Water Reuse Research projects

FP6 ERAPHARM - Environmental Risk Assessment of Pharmaceuticals F&F - pharmaceutical products in the environment: development and employment of novel methods for assessing their origin, fate and effects on human fecundity NORMAN – Network or reference laboratories for monitoring of emerging environmental pollutants KNAPPE – Knowledge and Need Assessment on Pharmaceutical Products in Environmental Waters Research projects

Review the occurrence of PPs in the aquatic environment, their removal by water treatment processes, the regulation currently in progress, their health and environmental impacts, eco-pharmacostewardship and eco-pharmacovigilance approaches Identification of actions to limit the discharge in the environment http://www.knappe-eu.org/ KNAPPE project

Review effectiveness of current and potential STP processes for removal of PPs Increase knowledge of the environmental effects of PPs Develop intelligent testing strategies for chronic toxicity assessment Further investigate fate of PP’s in STPs Evaluate role of environmental monitoring in risk assessment Evaluate practicalities of adopting a “green pharmacy” KNAPPE project - recommendations

Evaluate effectiveness of classification schemes Unused medicines management Evaluate methodologies to better inform public Evaluate need for policy framework reform KNAPPE project – recommendations

January 2009 To review the knowledge on pharmaceuticals in the environment Final report in preparation EEA workshop on Pharmaceuticals in the Environment

EQS for PPs should be defined and experience in ERA for other chemicals to be used ERA of pharmaceuticals Consideration of eco-classification Promotion of green pharmacy Improvement of take back schemes Improvement of waste water treatment Improvement of data availability and evaluation (collection of exposure data, ERA) EEA workshop on Pharmaceuticals in the Environment – recommendations

Holder of the marketing authorisation shall be allowed to disseminate to the general public certain information on medicinal products subject to medical prescriptions Among those information also ‘information on the environmental impact of the medicinal material’ Information to patient – COM (2008) 663

ENV.2010.1.2.2-2 Human health and environmental effects of exposure to pharmaceuticals released into environment: Improve the knowledge on risks related to human health and ecosystems, due to the exposure to pharmaceuticals and their derivates, which are released into the environment The studies can include innovative measurement strategies, sampling techniques, modelling and database building Effects of mixtures should be considered Research – FP7

Water Framework Directive 2000/60/EC Pollution caused by certain Dangerous Substances Directive (2006/11/EC) Environmental Quality Standards Directive Groundwater Directive (2006/118/EC) Urban Waste Water Treatment Directive (91/271/EEC) Drinking Water Directive (98/83/EC) Pharmaceuticals products are covered Water legislation

Regulation at Member State level: main/specific pollutants – substances posing a risk to or via the aquatic environment at basin or national level, including substances with properties which may affect steroidogenic, thyroid, reproduction or other endocrine-related functions Regulation at EU level: standards set for 33 priority substances and 8 other pollutants (no pharmaceuticals yet), but … Water Framework Directive by 13/01/2011 COM should prepare a new proposal • review of the list of priority substances (Annex X of WFD) as well as corresponding standards for water, sediment and/or biota • amend existing acts or to establish new legislations on control measures

Significant risk to or via aquatic environment, including to surface waters used for drinking water Identification of risks through Risk assessments carried out under Existing Substances Regulation 793/93, Pesticides Directive 91/414/EEC and Biocides Directive 98/8/EC, or Targeted risk assessment focusing only on toxicity to or via aquatic environment (REACH transitional dossiers, voluntary risk assessment), or Review of the priority list

Simplified risk-based assessment procedure based on scientific principles and taking into account intrinsic hazard (aquatic ecotoxicity and human toxicity via aquatic exposure route), monitoring data, and production volumes and/or use patterns Identification of priority hazardous substances (sub-set of priority substances) REACH – Substances of Very High Concern (SVHC) Persistent Organic Pollutants (POPs) Persistent, Bio-accumulative and Toxic substances (PBTs) Review of the priority list Pharmaceuticals covered Monitoring and modelling based prioritsation methodology  CIS WG E on priority substances

Council conclusions calling to promote mutual cooperation between all DGs and facilitate cooperation among MS on all aspects of AMR Commission staff working paper in preparation as a response to the Council conclusions: To provide overview of ongoing activities To identify possible areas for further action Antimicrobial resistance (AMR)

Impact of antimicrobial excretion on the environment should be monitored Monitoring of use of antimicrobials in veterinary medicine Prudent use of antimicrobials Antimicrobial resistance (AMR)

Objectives To identify problem of endocrine disrupters, its causes and consequences To identify appropriate policy actions on the basis of the precautionary principle Strategy on Endocrine disrupters COM(1999)706

Establishment of a priority list of substances Information exchange and international coordination Communication to the public Identification and assessment of EDCs Research and development Legislative action Strategy on Endocrine disrupters COM(1999)706

European Commission Peter.Korytar@ec.europa.eu http://ec.europa.eu/environment/

Commission’s Communication A renewed vision for the pharmaceutical sector