(29 January 2015 – Brussels): Health Care Without Harm (HCWH) Europe and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have come together to release the report and conclusions of their recent debate on Pharmaceuticals In the Environment (PIE), jointly hosted in Brussels on 24 October 2014.

Health and environmental regulators, academics, healthcare professionals and the pharmaceutical industry are committed to working together to improve understanding of pharmaceuticals in the environment, understanding their possible impact on human and environmental health – and to work towards solutions. Clearly medicines are of critical importance to patients, their families, carers and wider society, however concerns have been raised over potential negative impacts from concentrations of pharmaceuticals found in water, soil and plants.

This was the basis of the joint workshop organised by EFPIA and HCWH Europe.

The debate was organized around three key issues:

• Managing environmental criteria in research and development, manufacturing and supply chain
• Use of Pharmaceuticals
• Disposal of Pharmaceuticals

Identifying solutions

At the debate several possible solutions were discussed to address Pharmaceuticals in the Environment.

Funded through the Innovative Medicines Initiative, there is for example already an Intelligence-Led Assessment of Pharmaceuticals in the Environment, which aims at developing predictive frameworks that utilize information from existing datasets on environmental fate and effects from active pharmaceutical ingredients, toxicological studies, pharmacological mode of action and in silico models to support more intelligent environmental testing of pharmaceuticals in development and to prioritize legacy pharmaceuticals for full environmental risk assessment and/or environmental (bio) monitoring.

Managing environmental criteria is a key element of addressing issues at every stage of product development. Industry stakeholders are emphasizing the importance of continuous monitoring of environmental impacts and speaking for an innovative concept of extended environmental risk assessment (eERA). In relation to this, industry is also keen to promote the better use of EPAR (European Public Assessment Report) and making ERA data available as some companies do voluntarily already at the moment. 

The need to expand and broaden the ERA was also emphasized by civil society organisations. Representatives stated that ERA should be applied to all pharmaceuticals on the market and more information and end points should be taken into consideration. Stakeholders from the non-profit sector also urged their industry counterparts to demonstrate long-term commitment to developing 'green' active pharmaceutical ingredients that produce minimal waste, have increased bioavailability and do not persist in the environment. 

Anja Leetz, Executive Director of HCWH Europe states: “We need the environmental risk assessment as part of the decision–making process in the market authorisation for both human and veterinary medicine, in order to protect the environment. Once pharmaceuticals are in the environment we need to act swiftly, monitor them closely and take steps to reduce pharmaceutical residues to protect our water, soil and food. 

Despite sometimes differing views of solutions on how stakeholders should address the environmental concern of pharmaceuticals, the joint workshop provided a place to put these proposals on the table and have an open discussion.

Richard Bergström, Director General of EFPIA says “Collaboration is central to building our understanding of how pharmaceuticals impact on the environment.  EFPIA is committed to working with stakeholders to identify practical solutions that address concerns over pharmaceuticals in the environment and safeguard the future of innovative medicines development and manufacture. The pharmaceutical industry has developed an Eco-Pharmaco-Stewardship (EPS) proposal, which has the potential to offer solutions throughout a pharmaceutical product’s life cycle”

All stakeholders agreed on the importance of collaborating in raising public awareness and educating physicians and other healthcare professionals, particularly on the safe disposal of medicines: EFPIA is taking the lead on developing a communications campaign around this issue and invites other stakeholders into collaboration.

For media contacts and the full PDF press release, please click here.