Commission’s Communication

A renewed vision for the pharmaceutical sector

Peter KorytárEuropean 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)

Water legislation

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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

Monitoring and modelling Monitoring and modelling based prioritsation methodology based prioritsation methodology CIS WG E on priority substancesCIS WG E on priority substances

Pharmaceuticals covered

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

http://ec.europa.eu/environment/

European Commission

Peter.Korytar@ec.europa.eu