1Pharmaceuticals in the environment
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Committee’s assessment |
Politically important |
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Not cleared from scrutiny; further information requested; drawn to the attention of the Environment, Food and Rural Affairs Committee, Environmental Audit Committee and the Health and Social Care Committee |
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Document details |
Commission Communication: European Union Strategic Approach to Pharmaceuticals in the Environment |
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Legal base |
— |
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Department |
Environment, Food and Rural Affairs |
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Document Number |
(40476), 7680/19, COM(19) 128 |
Summary and Committee’s conclusions
1.1The treatment of many diseases in humans and animals relies on access to effective pharmaceuticals. At the same time, pollution caused by some pharmaceuticals is an emerging problem, with evidence of risks to the environment and, in relation to antimicrobial resistance, potentially to human health. Residues of pharmaceutical products may enter the environment during their manufacture, use and disposal. The European Commission’s document sets out a strategic approach to the issue, identifying several objectives and areas for action.
1.2Pharmaceutical residues have been found in surface and ground waters, soils and animal tissues across the EU at various concentrations depending on the pharmaceutical and the nature and proximity of the source. Studies have shown direct effects on wildlife from some pharmaceuticals found in water and soil. Male fish, for example, have become feminised by exposure to the main ingredients of the contraceptive pill (oestrogen and progesterone), thus affecting the capacity of the population to reproduce. While no direct effect on human health has been established, it is considered that the presence of antimicrobial (antibiotic and antifungal) pharmaceuticals in water and soil is playing a role in accelerating the development, maintenance and spread of resistant bacteria and fungi. This makes antibiotics less effective and is known as antimicrobial resistance.
1.3The largest source of pharmaceuticals entering the environment is by use, either human or veterinary. Pharmaceuticals mainly reach the environment through: the discharge of effluent from urban waste water (sewage) treatment plants; the spreading of animal manure; and aquaculture (fish farming), in which pharmaceuticals are often dispensed with the animal feed. Other sources are: the discharge of effluent from manufacturing plants; the spreading of sewage sludge; grazing livestock; the treatment of pets; and improper disposal into landfill of unused pharmaceuticals and contaminated waste.
1.4Six areas for action are identified:
- increase awareness and promote prudent use of pharmaceuticals;
- support the development of pharmaceuticals intrinsically less harmful for the environment and promote greener manufacturing—the pharmaceutical industry should be encouraged to take the environment more into account through the design and manufacturing stages;
- improve environmental risk assessment and its review—data sharing and improved access to data could facilitate better risk management, as could retrospective environmental risk assessment for several products on the market, and earlier availability of the risk assessment data for human medicinal products;
- reduce wastage and improve the management of waste in order to reduce the risk to the environment—more advanced waste water treatment technology may be appropriate at some locations, and source control of the diffuse emissions from livestock farming appears to be particularly necessary;
- expand environmental monitoring; and
- fill other knowledge gaps—the Commission will consider supporting other areas of research, including antimicrobial resistance and the possible effects on humans of exposure to low levels of pharmaceuticals via the environment.
1.5The Commission identifies specific tasks and initiatives under each action area, falling either to the Commission exclusively or to the Commission along with stakeholders, Member States and/or the European Medicines Agency. The Communication focuses on actions that are starting, will be initiated and, in some cases, completed by 2020. The Commission states it will then take stock of progress made and decide on further steps whilst taking into account the outcomes of ongoing evaluations of the water legislation and relevant research.
1.6The Parliamentary Under Secretary of State for the Environment (Dr Thérèse Coffey MP) says in her Explanatory Memorandum that the Government is committed to ensuring that the UK’s environmental standards are maintained, reflecting commitments made under existing EU legislation and including the ability to adapt to scientific and technical developments. The Government will reflect on all the suggestions in the Communication before deciding on any specific action. The Minister notes that the document contains no obligatory changes to waste water treatment.
1.7The Minister’s response to this document is limited to a commitment to reflect on it. We consider this response to be far below the required analysis. We ask the Minister to set out the Government’s view on:
- the Commission’s definition of the problem; and
- the strength of the evidence underpinning the Commission’s conclusions.
1.8While we accept that the Government needs to reflect on its response to the proposed actions, it would be helpful if the Minister could set out any initial thoughts as well as a timetable for further reflection.
1.9It would also be helpful to set this work in the wider context of the UK’s withdrawal from the European Union. We see two particular elements that render UK engagement at this stage important:
- first, the UK and EU have committed under the Political Declaration to exploring the possibility of UK cooperation with the European Medicines Agency (EMA) and the European Chemicals Agency (ECHA) and agreed that, in this context, the UK will consider aligning with Union rules in relevant areas;
- second, the Political Declaration also includes commitments on maintaining a level playing field for environmental standards in order to ensure open and fair competition.
1.10Based on the mutual commitments made in the Political Declaration on the future relationship, it seems to us likely that future EU policy in this area will have some bearing on UK policy. This makes it even more important that the Minister provides much more analysis of the document.
1.11Given the importance of the environmental and health issues raised, we retain the document under scrutiny. We ask the Minister to respond by 5 June 2019. This chapter is drawn to the attention of the Environmental Audit Committee, Environment, Food and Rural Affairs Committee and the Health and Social Care Committee.
Full details of the documents
Commission Communication: European Union Strategic Approach to Pharmaceuticals in the Environment: (40476), 7680/19, COM(19) 128.
Previous Committee Reports
None.
Published: 21 May 2019