Brussels 17 May 2018
The signatories urge European policymakers to ensure that Europe’s response to the threat posed by the presence of pharmaceuticals in the environment (PiE) is taken seriously, and that present and future European action will be timely, resolute and coordinated in all relevant policies.
Especially in light of the looming and severe public health crisis posed by antimicrobial resistance (AMR) fuelled by, inter alia, pollution caused by pharmaceuticals throughout their life-cycle, we underline that only a multi-sectoral, multi-stakeholder approach can generate the required results for the continued health of people, animals and ecosystems, in Europe and globally.
The European Commission is set to release the long-awaited strategic approach to PiE, which will contain a series of measures to alleviate pollution and other damage caused by pharmaceutical residues released into the environment. The strategic approach follows the Commission’s 2017 follow-up Action Plan against AMR, which we regret falls short on the environmental side, and ignores clear evidence on the extent of pharmaceutical pollution.
European policies need to recognise that the increased presence of pharmaceuticals in the environment and the effects are entirely preventable – if Europe accepts its leadership responsibility to address the root causes and makes available dedicated resources.
Pharmaceutical active substances are currently excluded from EU environmental legislation, which is untenable in light of the risk that pharmaceutical pollution poses to the environment and to human and animal health. We therefore urge the European Commission to seize a number of important policy opportunities which, in combination, will mitigate the crushing effects of PiE and AMR.
Based on the evidence presented in the Annex and the background documents to the Commission’s consultation on PiE, the signatories of this statement propose the following recommendations:
- Revise the Good Manufacturing Practices (GMP) to include compulsory environmental standards
- Include medicinal and veterinary products under all of REACH titles in order to ensure adequate information and transparency on environmental occurrence and impacts of APIs.
- Introduce an EU monitoring system for the mandatory, routine collection of data on antimicrobials and AMR microorganisms in the environment.
- Introduction of legally binding concentration limits and standards for residues of pharmaceutical substances in water.
- Revise relevant Best Available Techniques (BAT) reference documents (BREFs) in the Industrial Emissions Directive (IED) to take into account environmental emissions of pharmaceutical ingredients during the manufacturing of pharmaceutical products, and on intensive rearing of poultry and pigs.
- Ensure that ERA results are systematically considered in the risk-benefit analysis of marketing authorisation decisions for new human medicinal products, coupled with compulsory ERAs for products put on the market before 2006.
- Set up public procurement in EU member states to favour human and veterinary medicinal products with low environmental impacts.
- Ensure extended producer responsibility for full life-cycle of products placed on the market.
- Support research into the various transmission dynamics of AMR via the environment.
- Task the EU One Health Network on AMR with ensuring policy coherence and alignment between AMR, PiE, water legislation and other relevant environmental strategies.
- Define criteria for veterinary pharmaceuticals that are especially hazardous to the environment, implement a system of comparative assessment and establish a process that denies authorisation for such APIs with no or strictly limited derogation.
- Develop comprehensive data collection for all antibiotics used in human medicine as well as in animal breeding and husbandry, and make those accessible to the public.
- Initiate EU-wide measures to improve animal welfare, livestock conditions and animal husbandry practices as important precaution measures to secure animal health and reduce the need for medication.