The growing problem of pharmaceuticals in the environment has been recognised as an emerging policy issue by the UN Strategic Approach to International Chemicals Management (SAICM), which adopted “Environmentally Persistent Pharmaceutical Pollutants” in its process in autumn 2015.
It was only recently, however, that the European Commission decided to start addressing this issue and published their consultation on pharmaceuticals in the environment (which closed on 21 February), seeking “views on possible actions to address the risks from pharmaceuticals in the environment”. This would inform their already delayed strategic approach to pharmaceuticals in the environment – due in September 2015 according to Article 8c of Directive 2013/39/EU, it is now expected by the end of May 2018.
HCWH Europe has been working to tackle pharmaceuticals in the environment for the past six years. The goal of our work on pharmaceuticals is to support their safe production, management and disposal, while reducing their environmental and health impact throughout their life cycle. We also aim to foster innovations for green products. We currently lead the only EU-wide campaign dealing with the presence of pharmaceuticals in the environment – Safer Pharma.
HCWH Europe has organised workshops and webinars, and published a variety of materials – position papers, reports, brochures and infographics, as well as attended meetings with the European Commission on issues related to pharmaceutical pollution in the environment.
A multitude of pharmaceuticals can be found in the environment: antibiotics, antidepressants, anti-inflammatories, anti-cancer drugs, contraceptive pills – practically everything we produce and consume. There are not enough detection methods to monitor all these different types of molecules; we don’t even know the safe concentration levels in the environment for most of these molecules or how long term exposure from pharmaceutical pollution may affect our health. Learn more with our Safer Pharma video:
HCWH Europe’s Pharmaceuticals Policy Officer, Dr Adela Maghear, said:
“The presence of pharmaceuticals in the environment is not just an isolated case – we face a global pharmaceutical pollution problem. It’s foolish to think that this will not affect us; we must acknowledge the seriousness of the problem – with no preventative measures in place to avoid exposure, the environment and our health are part of an unregulated experiment. Immediate action in line with the precautionary principle is required to protect human and environmental health.”
In HCWH Europe’s response to the European Commission public consultation, we presented a series of policy measures that would help reduce pharmaceutical pollution in the environment:
- Develop and promote guidelines on how to identify and design “green pharmaceuticals”(i.e. pharmaceuticals that pose lower risk to the environment).
- Encourage Member States to review their ethical procurement policies at national level with a view to including environmental criteria in contractual requirements.
- Demand more transparency in the pharmaceutical supply chain: The pharmaceutical industry should disclose the origin of their pharmaceuticals by providing information regarding where the active pharmaceutical ingredients were produced, therefore ensuring a complete traceability profile for all pharmaceuticals in the supply chain. This will improve both production practices and patient safety.
- Set Environmental Quality Standards (EQS) for pharmaceuticals in groundwater and surface water.
- Ensure that Environmental Risks Assessments (ERAs) adequately consider the combination effects of mixtures.
- Ensure that pharmaceutical substances added to the Water Framework Directive’s Priority Hazardous Substances List are automatically classified as hazardous waste under the Waste Framework Directive and Commission Decision 2000/532/EC establishing the List of Wastes.
- Include active pharmaceutical ingredients in the list of main pollutants within the Water Framework Directive (Annex VIII).
- Amend the Sewage Sludge Directive to enforce monitoring for selected pharmaceutical substances.
- Set concentration limits for Active Pharmaceutical Ingredients (APIs) in different environmental compartments.
Compulsory requirements are needed for the existing legislation to guarantee that several measures are implemented at both the EU and national levels. Measures based on voluntary action are also important, but are not enough to insure the protection of both EU citizens and the environment.
Dr. Maghear, adds:
“We already know enough information to justify taking action on the hazards and risks posed to the environment and human health by the production, use, and disposal of pharmaceuticals. Over 20 years of scientific publications and several EU funded projects in this field have clearly proven that pharmaceutical pollution monitoring is out of our control – there should be no further questions on the need for action; it is time to act.”