European Pharmaceutical Industry Perspective, Sustainable development – today and in the future Mike Murray Chair of EFPIA EH&S AHG MPA Conference Uppsala 10 November 2009 1

OUTLINE EFPIA The Pharmaceutical Industry approach to sustainability Engaging with stakeholders Working to improve the science Sources of pharmaceuticals in the environment (PIE) The current situation on PIE Sustainability Third party manufacture/supply Conclusions 2

EFPIA EFPIA represents 31 national pharmaceutical industry associations and 44 leading pharmaceutical research companies operating in Europe. EFPIA's membership is proactively involved in the research, development and manufacture of medicinal products for human use in Europe EFPIA seeks to improve the competitiveness of Europe as a pharmaceutical base by the development of a regulatory and political environment, which will stimulate R&D and reward innovation EFPIA reviews and assesses environmental matters through its Environmental, Health & Safety ad hoc Group 3

The Industry Approach to Sustainability Engage on the subject Engage co-operatively and transparently on this subject with other stakeholders Seek through this co-operation to understand better the issues and factors involved Control what can be controlled Reduce factory emissions, by continuous improvement of manufacturing processes Reduce the wastage of medicines and encourage and support the development of schemes to ensure the proper disposal of unused medicines Improve Risk Assessment Development of better exposure modelling Application of Environmental Risk Assessment Mode of action evaluation Process Development Inclusion of environmental considerations as part of process development 4

Engaging with Stakeholders Various member associations of EFPIA have been involved in discussions in this area with regulators at national level over a number of years. Swedish trade association, LIF, in collaboration with other stakeholders, initiated the environmental classification system for medicinal products previously described EFPIA encouragement of and contribution to the development of the EMEA ERA Guideline. EFPIA continues to support the principle of the Guideline More recently, EFPIA had close involvement with and support to the KNAPPE project under the EU 7th Research Framework Programme 5

Working to Improve the Science The pharmaceutical industry works with academic institutions and government agencies to improve our scientific understanding of: How medicines degrade in the environment and how this could be better predicted How the ecotoxicology of drugs could be better predicted by using data from mammalian studies How the chronic impacts of ‘atypical’ active ingredients might be predicted 6

PRINCIPAL PATHWAYS FOR PHARMACEUTICALS INTO THE ENVIRONMENT Wastewater Treatment ? Drinking Water Treatment Landfill ? Incineration

The Current Situation on PIE Advances in analytical science now enable us to detect residues of pharmaceuticals in the environment that were previously undetectable Concentrations in water bodies are of a very low order and very unlikely to present a significant risk to human health. The volume of data on potential long term environmental impacts is increasing, and varied, although to date there are limited reports of observable impacts More targeted products (particularly biologicals) with lower environmental impact are reaching the market and over time will lessen the exposure of the environment to pharmaceuticals. The European Commission in its document ‘Safe, Innovative and Accessible Medicines: A Renewed Vision for the Pharmaceutical Sector’ indicates a consideration of integrating environmental information on medicines into the current EU legislative framework 8

Sustainability - Some Sustainable Manufacturing Initiatives Product and Process Design – Initiatives to share experience on the development of ‘green chemistry’ techniques (e.g. Pharmaceutical Round Table of the Green Chemistry Institute) Many member companies are implementing energy saving initiatives to reduce greenhouse gas emissions ‘Greener’ packaging – improved design to minimise environmental impact of packaging 9

Third Party Manufacture and Supply – Why? Companies are more and more looking to rationalise supply chains In addition they are identifying ‘core’ business activities. In many cases, where ‘non-core’ activities can be performed more economically and to the required standard, companies are contracting out such activities to third parties having the appropriate technological capability Such contract operators may be located anywhere in the world 10

Third Party Manufacture and Supply Examples of methods used to confirm environmental performance include: Working with suppliers and sharing relevant information and good practices in order to reduce impacts to the environment arising from activities. Auditing own facilities and those of contract suppliers to ensure that appropriate environmental standards are maintained in those facilities wherever they may be located 11

Conclusions EFPIA welcomes the opportunity to speak today EFPIA is committed to playing an ongoing and important role in the debate with other stakeholders on sustainability and to being open and constructive in these discussions EFPIA members seek to minimise the effects of their products and activities on the environment either in their own facilities or those of contractors or suppliers wherever they may be located. EFPIA seeks and looks forward to ongoing discussion on environmental and sustainability issues with the European Commission and other stakeholders 12

THANK YOU FOR YOUR ATTENTION Contact: Mike Murray Tel: +44 (0)20 7747 1421 Email: mmurray@abpi.org.uk 13