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Office of Technology Assessment at the German Bundestag Office of Technology Assessment at the German Bundestag

Information on the project

Medical and veterinary active ingredients in drinking water and watercourses – quantitative analysis and risk assessment

Thematic area: Energy, resources, environment
Analytical approach: TA project
Topic initiative: Committee on Education, Research and Technology Assessment
Status: ongoing
Current project phase: Report completed. Approval by the Committee on Education, Research and Technology Assessment pending
Duration: 2014 till 2018

Background and central aspects of the topic

Pharmaceutical products are widely used in human and veterinary medicine. Some of these products find their way in changed or unchanged form via waste water, seepage etc. into the ground and ultimately into watercourses where they can then also have an impact on human health via drinking water and the food chain. This problem could become even more serious in future because, on the one hand, the sale and consumption of these substances is increasing and, on the other hand, climatic changes make greater fluctuations in the water regime more probable (e.g. periods of drought with accumulation of pharmaceutical substances in watercourses, heavy rainfall with flooding). Reducing and preventing environmental contamination by, and health impacts of, pharmaceutical products in the water – or, in general, dealing with micropollutants in watercourses – represent major challenges for society as a whole.

New analytical methods now allow extremely small levels of potential contaminants to be detected, which was not technically possible for a long time. The methodological innovations are also changing the way risks are assessed. In Germany to date, however, the presence and concentrations of pharmaceutical products in watercourses have not been systematically monitored, though random testing and estimates indicate a rise in pharmaceutical residues and other micropollutants in watercourses and drinking water. Although our knowledge of the exact impacts of these residues on health and the environment is incomplete, there are sufficient indications, however, that at least some of the pharmaceutical residues constitute a serious health risk to people and the environment.

A nationwide study carried out for the first time by the Bund/Länderarbeitsgemeinschaft Chemikaliensicherheit (BLAC - German Federal/State Working Party on Chemical Safety) in 2001 showed that some 40 drugs can be widely detected in watercourses. A study (2001) commissioned by Germany's Federal Environment Agency (UBA) found over 130 active ingredients in surface waters. Overall, however, the level of data available in respect of micropollutants is still unsatisfactory. Twelve large joint projects funded by Germany's Federal Ministry of Education and Research (BMBF) under its « Risk Management of Emerging Compounds and Pathogens in the Water Cycle« (RiSKWa) funding measure are currently addressing the issue of how the provision of high-quality water can be safeguarded and preventive health and environmental protection can be guaranteed by means of innovative technologies and strategies and by using dynamic risk management. At an EU level a large joint project titled »ModelKey« was run in the period 2005-2010, and a further major project (»Solutions«) involving 39 internationally renowned research institutes was launched in October 2013.

Experts agree, and the issue of micropollutants is also covered by their verdict, that the consumption of drinking water in Germany does not currently entail acute health risks. Nevertheless, there are indications of possible harmful effects (such as, for example, the reduction in human fertility, the rise in certain cancers in humans, and the »feminisation« of fish). The fact that – currently, at least – it is almost impossible to scientifically demonstrate negative impacts on health and the environment remains a complicating factor. The variety of pharmaceutical products, the low active concentrations of the substances in watercourses (which, in addition, can only be detected using elaborate equipment), the combination of substances and their decomposition products (»cocktail effect«) and the lack of clarity about their long-term effects hinder the accurate assessment of consequences.

Various approaches to reducing or completely preventing the contamination of water ecosystems and drinking water with pharmaceutical residues and micropollutants are currently being discussed. The possible strategies are: not releasing any polluting substances into the environment in the first place, reducing the discharge levels of such pollutant residues, changing their quality such that damage is avoided, or keeping the contaminating substances out of drinking water at least.

The following approaches are currently under discussion:

  • Expansion of central waste water treatment works to include a fourth purification stage which can eliminate micropollutants
  • Measures to reduce the general consumption of pharmaceutical substances (more targeted use, retail pack size appropriate to need, labelling of environmental impacts etc.)
  • Options for environment- and user-friendly disposal of surplus products
  • Development of more environment-friendly products (e.g. green pharmacy); marketing authorisation regulations for medicines, for instance, play a central role in this regard.

The first strategy, in particular, i.e. the expansion of waste water treatment works to include a fourth purification stage, seems to represent a good technical solution to the problem in the short to medium term, though it is cost- and energy-intensive, as demonstrated by assessments from, for example, Switzerland and the German state of North Rhine-Westphalia. In addition, it only deals with part of the problem since an estimated 30% of municipal sewage finds its way into groundwater and surface waters without passing through a waste water treatment works and would therefore also be unaffected by a fourth purification stage. In general, it is foreseeable that many substances cannot be kept out of watercourses completely using technical means.

Objectives and approach

The problem of micropollutants in watercourses is a social issue which requires conflicting interests to be weighed. On the one hand, major damage can be caused in the long term; on the other hand, comprehensive technical solutions can incur high costs. A balance has to be found here. The questions of which risks can and should be tolerated by society and of what form a good risk management system could take also play a role. No quick fix can be expected because, on the one hand, substantial investment in infrastructures and/or innovative products is necessary and, on the other hand, the consumption and thus the distribution of pharmaceutical products are difficult to regulate. Furthermore, the decomposition of the substances in question in the ecosystems is often associated with long time lags (persistence of many pharmaceutical products). All these aspects mean that solutions can only be achieved over relatively long timeframes, and this underlines the urgency of early action.

The aim of a TA project relating to this issue is to systematically collate and process the available knowledge from various fields (science, economics, law etc.) and highlight any gaps in this knowledge as a platform from which to identify possible action strategies for government, the relevant authorities and the scientific community. The aspects set out below as relevant are to be addressed in the course of the TAB project:

It is intended to provide an overview of relevant substances and estimates of material balances of selected substances in Germany together with a comparison with other countries, which will put the results in a European or international context. In addition to the current situation, further trends which can already be identified should also be taken into account – for example, developments in the use of pharmaceutical products (with reference to type and quantities). When analysing the entry paths of micropollutants, hotspots are also to be highlighted.

With reference to a risk assessment of pharmaceutical residues and micropollutants, a literature study and review will be conducted into the environmental impacts and (eco)toxicity of selected active ingredients and their limit values. The effects of individual contaminations, cumulative effects of multiple pollutants and also the long-term effects of low concentrations are also to be examined.

Apart from the question of risks, methodological problems are also relevant. The challenge for policy-makers and the authorities lies in efficiently organising access to the necessary data and knowledge and translating scientific findings in assessment processes into measures to mitigate the identified risks. In this regard, an overview is to be provided of the legal position in terms of marketing authorisation, consumption and disposal and of the rights and responsibilities in terms of publishing data and information.

Alternative technical strategies to mitigate the risks taking account of economic, environmental social, political and legal aspects are to be examined. These would include looking at technical approaches (e.g. fourth purification stage in waste water treatment works, partial stream analyses or discrete pretreatment of wastewater from, for example, doctors' surgeries and hospitals), measures aimed at reducing the general consumption of medicines (e.g. information campaigns among consumers, the medical fraternity, pharmacies, adaptation of dosages etc.) and the potential of innovative medicine designs with product-integrated environmental compatibility.

Finally, an attempt will be made to draw up an overview of socioscientific analyses of societal debates for assessing and weighing up conflicting aims with regard to the potential risks of pharmaceutical residues for general health and the environment when viewed against individual rights to expect to be cured and to have unrestricted access to medicines.