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Thomas Backhaus receives financial support from FORMAS to rank systematically antibiotics and hormonal drug

The project “SysPIE”, is supported with MSEK 2.998

Especially in this day and age it is obvious, how important pharmaceuticals are to safeguard public health. Unfortunately, as a consequence of their intended use, those highly active chemicals find their way into the environment, after excretion from the patient. This has shown to cause sometimes substantial risks to exposed organisms and the creatures inhabiting it. As a result, the European Commission has published a “Strategic Approach to Pharmaceuticals in the Environment” in 2019, highlighting the need for an improved strategy tailored towards the risk-driving pharmaceuticals, and to act on the “cocktail effect” of pharmaceuticals. SysPIE directly contributes to both tasks.

Currently there are around 1900 different pharmaceuticals used in Europe, of which ~90% are not adequately assessed for their environmental risks. However, simply testing all those pharmaceuticals in the necessary biotests and monitoring them in the environment would require thousands of animal experiments, would take an incredibly long time and would cost a fortune. In order to focus the efforts, we therefore first need a systematic, sufficiently reliable and pragmatically useful strategy to prioritize and rank all the pharmaceuticals used by European citizens. Only then can efforts by regulatory authorities and industry focus on the actual risk drivers.

SysPIE will provide such a ranking for two particularly relevant groups of pharmaceuticals: antibiotics and endocrine-active pharmaceuticals. After SysPIE has filled this gap, a systematic prioritization and ranking of all the pharmaceuticals in the EU will be available for the first time.

In the environment, pharmaceuticals never occur on their own. Instead, they always appear as complex mixtures, with other pharmaceuticals but also with other hazardous chemicals, such as pesticides and biocides. After completing the single-substance assessment, SysPIE will therefore implement a state-of-the-art mixture risk assessment, in order to determine the overall risk of pharmaceuticals in the environment, and in order to assess how big the risk contribution is from pharmaceuticals, in comparison to all the other chemicals found in the environment. In order to do so, SysPIE will in particular assess whether and to what extend synergistic mixture effects are to be expected, which pharmaceuticals are involved and which organisms might be particularly vulnerable to such interactions. In the end, this will provide a highly realistic overall risk assessment.

Finally, SysPIE will determine the consequences of its findings for the regulatory assessment of the environmental risk of pharmaceuticals. Where are possibilities for simplifications (without jeopardizing the protectiveness of the assessment), where is a need to improve the current approaches (without increasing the resource requirements sky-high)? This will be done especially with respect to the following three issues:

1)      Generic cut-off criteria, so-called “action limits” set a lower limit for the concentration of a given pharmaceutical in the environment below which the likelihood of environmental harm is sufficiently small, so that no (or only limited) biotesting and animal experimentation is required. Currently, antibiotics as well as endocrine-active pharmaceuticals are specifically excluded from using this approach during their assessment. Successfully extending the action limit approach also to these two classes by using the data collected by SysPIE would lower (animal) testing requirements as well as costs, without jeopardizing the protectiveness of the assessment strategy.

2)      The current regulatory biotesting strategy might require revision in view of the data collected by SysPIE. For example, a key biotest for the assessment of antibiotics is currently a growth-inhibition assay with blue-green algae, which is thought to represent prokaryotic organisms. However, it is currently insufficiently clear whether such an algae is actually representative for the real target organisms (bacteria). The data that SysPIE will collect will help to answer that question and recommend, if needed, more suitable, bacteria-based assays.

3)      We have recently recommended to the Swedish government to employ a so-called “Mixture Allocation Factor” (MAF) for the risk assessment of chemical mixtures. SysPIE will estimate an appropriate size for such a MAF for pharmaceuticals in the environment.

All the work of SysPIE will be accompanied by dedicated communication and dissemination efforts. For this purpose, SysPIE will not only team up with experts from the Center for Future Risk Assessment and Management (FRAM) at the University of Gothenburg as well as Gothenburg’s Center for Sustainable Development (GMV). By combining these expertises, SysPIE will ensure that the project’s results will be disseminated timely to all relevant stakeholders (pharmaceutical industry, water industry, regulatory authority in Sweden and Europe, civil society organizations), as well as the scientific community.