June 13, 2013 by David Taylor


There are currently two major programmes of research being undertaken under the EU Framework 7 Programme concerned with the issue of pharmaceuticals in the environment: CYTOTHREAT is concerned with the fate and effects of cytostatic pharmaceuticals in the environment and identification of biomarkers for an improved risk assessment on environmental exposure whilst PHARMAS is concerned with the ecological and human health risk assessments of antibiotics and anti-cancer drugs found in the environment

As part of their communication programme the PHARMAS project team organised this conference to discuss current issues. The meeting programme was divided into three segments dealing with a) Policy actions being taken at a European level, b) a much larger section on Environmental and Human Health Risk Assessments concluding with a short section on c) Perspectives on problem assessment and future actions.

The meeting began with a Key Note lecture from Susan Jobling (Brunel University) on the societal dilemma posed by EE2: clear evidence that its discharge was contributing to significant fish feminisation but with recognition that its use was essential and that advanced effluent treatment to control its release would be extremely expensive.

a) Policy actions being taken at a European level.

Following on from the EE2 presentation, this session was primarily concerned with the Water Framework Directive and in particular the inclusion of pharmaceuticals into the priority substance list and the proposal to implement a “Watch List”. Since the current proposals are still subject to final agreement and possible change, the discussion was somewhat hypothetical. However, it was interesting to hear that although the three pharmaceuticals currently under discussion (EE2, Estrone and Diclofenac) were now being proposed for the Watch List, they were considered by the Commission to be in a different category to other potential Watch List Candidates. As far as the Commission was concerned these substances had already been shown to constitute a significant risk and further information from the Watch List process would not change their status.

In addition it was announced that the report commissioned by DG SANCO on the PIE issue would be published in July.

b) Environmental and Human Health Risk Assessments.

This was a very wide ranging session. Following an interesting overview of the current state of the science by Bryan Brooks of Baylor University, 14 further papers were presented on all aspects of this subject by academics, regulators and industry scientists. Subjects covered included the impact of hospital waste discharges, the development of mammal to fish read across techniques, prioritisation methodologies and antibiotic resistance.

Papers of particular interest were some new studies on the ecotoxicology of Diclofenac presented by Andreas Hartmann (Novartis), including the results of an independent expert audit of two of the three previous studies. This clearly showed that previous studies were flawed and that the new data, which demonstrated a substantially lower level of impact, was the most reliable. Oliver Straub (Roche) presented an in depth study of the environmental risk assessment of trimethoprin in which he showed an excellent agreement between measured environmental concentrations and those predicted from a comprehensive ERA.

Finally a seminal paper by Maja Kuzmanovic (Barcelona Institute of Environmental Assessment and Water Research) presented information on both the distribution and the calculated environmental risk assessment of 180 micropollutants (including 80 pharmaceuticals) in four Iberian river basins. The data demonstrated that only 5% of the total environmental risk could be attributed to pharmaceuticals.

c) Perspectives on problem assessment and future actions.

Thomas Senac (Sanofi) and I provided the plenary introduction to the last session on problem assessment. In our view there was no rational reason to differentiate pharmaceuticals as a class from the more general grouping of emerging micro pollutants. Pharmaceuticals have no chemical biological or structural similarity and can only be identified by the use to which they are put. Any substance has the potential to be used as a pharmaceutical and although individual pharmaceuticals might be of importance as environmental pollutants this needed to be assessed on a case by case basis.

Other papers of interest in this session dealt with an opinion poll on the potential utility of an EU wide environmental classification scheme for pharmaceuticals and a UBA sponsored initiative to produce a global database of measured concentrations of pharmaceuticals in the environment. This project was intended to support initiatives being proposed for SAICM, and although laudable in its objectives raised significant issues surrounding quality control of the data being assembled.

Conclusions

I detected a gradual change in attitude towards the issue. In the past there has been a general assumption that pharmaceutical residues in water represented a major threat to the environment (and possibly to sensitive human populations) and that action needed to be taken rapidly to reduce the input of all pharmaceuticals. As a consequence we felt that our paper would be somewhat iconoclastic and might receive a rather hostile reception. However, far from being a lone voice, the message in our paper: that pharmaceuticals as a group were no different to other groups although individual pharmaceuticals might be problematic, was echoed by a number of speakers.

The organisers arranged a snapshot opinion survey of the delegates at the end of the conference as to what degree of risk was posed by the current level of pharmaceutical residues in the environment. The results were unexpected considering that the attendees were predominantly from the academic and regulatory communities. Of the 70% of the delegates that voted 15% thought it was a major problem, 64% a significant problem, 18% a minor problem and 3% that it wasn’t a problem at all. At previous meetings I would have anticipated that >90% of the delegates would have voted it as being a major problem.

Presentations made at the conference are not being made public, however all presenters have the opportunity to submit written papers for a special edition of Chemosphere to be published at the end of 2013. In addition the PHARMAS team has created a short video, available on YouTube which tries to put the issue into perspective for the general public, in particular to allay fears about the safety of drinking water.