Pharmaceuticals in the Environment
Pharmaceuticals can enter the environment at all stages of their life cycle: manufacturing discharges, excretion during use or improper disposal. This issue requires, however, a balanced approach: medicines play a critical role in ensuring a high level of public health, and political debates on pharmaceuticals in the environment should not overlook the value that medicines bring to European citizens.
The pharmaceutical industry is committed to minimising the impact of medicines on the environment
Minimising the impact of medicines on the environment while safeguarding access to effective treatments for patients is a critical issue across all sectors of the pharmaceutical industry.
The European pharmaceutical industry, represented by the Association of the European Self-Care Industry (AESGP), the European Federation of Pharmaceutical Industries (EFPIA) and Medicines for Europe, recognises and understands the concerns as regards the presence of pharmaceuticals in the environment. It has been the driver behind the development of the Eco-Pharmaco-Stewardship (EPS) concept, a proposal that strives to protect patients’ access to medicines while appropriately considering environmental aspects, and a number of projects, such as the #MedsDisposal campaign, on the proper disposal of medicines, and the Innovative Medicines Initiative’s project “iPiE” (Intelligence-led Assessment of Pharmaceuticals in the Environment), which identifies and prioritises medicines that are most likely to present a risk to the environment.
About the Eco-Pharmaco-Stewardship
The Eco-Pharmaco-Stewardship (EPS) is composed of 3 pillars:
PILLAR 1 – A research project
Intelligence-led Assessment of Pharmaceuticals in the Environment (iPiE) is a public-private partnership aimed at filling the priority knowledge gaps for “legacy” active pharmaceutical ingredients (APIs), medicinal products approved before 2006, in order to support informed science-based policy-making on pharmaceuticals in the environment. The Innovative Medicines Initiative (IMI) iPiE project has released an online tool that summarises the properties, environmental toxicity and characteristics of active pharmaceutical ingredients. Dubbed “iPiE*SUM” (‘iPiE Summary Database Search’), the tool is designed to allow public and regulatory bodies to obtain a high-level overview of what studies were collected during the iPiE project and what eco-toxicity data and studies are available. This multi-stakeholder project was completed in June 2019.
PILLAR 2 – Exchange of good practices
Whilst the overall contribution of pharmaceutical manufacturing to the issue of pharmaceuticals in the environment is relatively low compared with that from other sources, the pharmaceutical industry has developed and is continuously implementing initiatives which minimise API discharges from manufacturing operations through the exchange of good practices. Coupled with this, the industry is proposing a ‘maturity ladder’ aimed at helping companies to gauge their performance and take improvement measures where needed on a risk-based approach. ‘A risk-based approach to managing active pharmaceutical ingredients in manufacturing effluent.’ (2016) Environ. Toxicol. Chem. Vol 35. No. 4. Pp. 813-822.
PILLAR 3 – Extended Environmental Risk Assessment (eERA)
The current ERA guideline requires that a pharmaceutical company assesses the environmental risk only theoretically and only once, before the drugs are approved and launched, or when they are going to be used in new indications or combinations. eERA intends to extend this framework: the EPS contends that the ERA should be reviewed and, if necessary, updated throughout the product’s lifecycle to reflect the latest information on the product’s potential impact on the environment. The focus should, however, be on the level of the substance entering the environment (not the product, as it is now) and that resources should be prioritised only on those substances that actually pose a potential risk to the environment.
Raising awareness on the proper disposal of medicines
#MedsDisposal is a joint initiative developed under the Eco-Pharmaco-Stewardship (EPS) and in collaboration with European healthcare, industry and student organisations.
It consists of a campaign to raise awareness on how to dispose of unused or expired medicines appropriately in Europe, bringing information on current disposal schemes in European countries to one place.Read more