Finding solutions together: EFPIA and health care without harm meet to discuss pharmaceuticals in the environment
21.10.14
Medicines help millions of people live healthier lives. The positive societal effects from pharmaceuticals, and the great importance to the individual patients and their family and friends, are hardly questioned by anybody today. However, concerns have been raised on potential negative impacts from the small quantities of pharmaceuticals present in water and other parts of the environment. Health and environmental regulators, academics and the pharmaceutical industry are working to assess the situation and find solutions. The impact of pharmaceuticals in the environment (PiE) – and their potential impact on human and animal health needs to be better understood. There is currently limited and non-conclusive evidence of human or environmental harm associated with PiE.
As part of the process to assess the situation and evaluate the potential need for actions, EFPIA in collaboration with Health Care Without Harm (HCWH) organises a workshop on October 24 at Science 14 Atrium in Brussels. Stakeholders from all relevant parts of society will discuss the PiE in a series of three sessions. The first one addresses “Managing environmental criteria in R&D, manufacturing and supply chain”; the second one “Use of pharmaceuticals”; and the third “Disposal of pharmaceuticals”. It will be a perfect setting for discussions of PiE throughout the life-cycle of pharmaceuticals, with positions being presented and debated by all stakeholders.
A key initiative for industry to bring to the table will be the Eco-Pharmaco Stewardship scheme (EPS). We believe that EPS addresses the most relevant questions associated with PiE. In EPS we suggest, amongst several other things, post-approval commitments as part of an Extended Environmental Risk Assessment process (eERA). Through such a process we feel that we would address the issues that have been raised regarding potential environmental risks with novel Active Pharmaceutical Substances (API) introduced on the market, without jeopardizing patient access to valuable medical treatment. Another important part of EPS is the public-private partnership IMI (Innovative Medicines Initiative) project iPiE (Intelligence-led Assessment of Pharmaceuticals in the Environment). The project aims to extend the scientific knowledge base and e.g. develop a high quality eco-database, develop effects and exposure prediction models, and address prioritization methodology for legacy products (i.e. older products without environmental data that have lost patent protection). A third pillar of the EPS initiative is the development of an industry guidance on manufacturing effluent management.
I am looking forward to the discussions on October 24, and I hope that the different stakeholders will be able to find common ground for a joint process forward. The EU Commission will present a PiE Strategy during fall 2015, and the outcome of the October 24 workshop could form an important basis for that strategy.
