SWEDISH SUMMARY: Marlene Ågerstrand försvarade sin doktorsavhandling "From Science to Policy - Improving environmental risk assessment and management of chemicals" på KTH i fredags. Marlene har bland annat studerat miljöklassificeringssystemet för läkemedelssubstanser som LIF i samarbete med flera intressenter lanserade på Fass.se 2005.
Marlene Ågerstrand had her PhD dissertation at KTH (Royal Institute of Technology) Friday Dec 7. The name of the PhD-Thesis is "From Science to Policy - Improving environmental risk assessment and management of chemicals". One important part of the work has been to evaluate and review the Swedish classification scheme for pharmaceutical substances on Fass.se which was launched back in 2005 by LIF (The Association of the Research-based Pharmaceutical Industry in Sweden) in collaboration with several stakeholders. In addition to Marlene's evaluation and review of the classification scheme (or the Swedish Environmental Classification and Information System for pharmaceuticals - SECIS - as it is referred to by Marlene), she also presents the WikiPharma database for environmental effect data for pharmaceuticals, a comparison of current reliability evaluation methods and a reliability evaluation of ecotoxicity data, and finally an improved reliability and relevance reporting and evaluation scheme. The thesis is a summary of the following papers:
Paper I Molander L, Ågerstrand M, Rudén C. 2009. WikiPharma - a freely available, easily accessible, interactive and comprehensive database for environmental effect data for pharmaceuticals. Regulatory Toxicology and Pharmacology 55: 367–371.
Paper II Ågerstrand M, Wester M, Rudén C. 2009. The Swedish Environmental Classification and Information System for Pharmaceuticals — An empirical investigation of the motivations, intentions and expectations underlying its development and implementation. Environment International 35 (5) 778-786.
Paper III Ågerstrand M, Rudén C. 2010. Evaluation of the accuracy and consistency of the Swedish Environmental Classification and Information System for pharmaceuticals. Science of the Total Environment 408: 2327–2339.
Paper IV Ågerstrand M, Breitholtz M, Rudén C. 2011. Comparison of four different methods for reliability evaluation of ecotoxicity data - A case study of non-standard test data used in environmental risk assessments of pharmaceutical substances. Environmental Sciences Europe 23: 17.
Paper V Ågerstrand M, Küster A, Bachmann J, Breitholtz M, Ebert I, Rechenberg B, Rudén C. 2011. Reporting and evaluation criteria as means towards transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals. Environmental Pollution 159 (10): 2487-2492.
It is kind of interesting to read a thesis where a system is being scientifically evaluated that you have been following all the way from the first ideas came up, through intense discussions with both Swedish and international stakeholders, through the design phase and then impementation and maintanance. And Marlene's evaluation is valuable - she has identified several areas for improvement.
Faculty opponent at the dissertation was Professor Andreas Kortenkamp from Brunel University in the UK.
It was a good and interesting discussion between Andreas and Marlene. And there were a few take-aways for me from that discussion. Among those take-aways:
- First of all Andreas' comment that this system could probably never have been implemented elsewhere. Sweden has a unique collaboration between all different stakeholders in society. I have to admit that it makes me kind of proud.
- Marlene's very important observation that several, if not most, of publications with toxicity and ecotoxicity data lack information allowing risk assessors to evaluate data reliability. Very often data on test protocols, dosing systems, controls, the testing environment or similar basic data are actually missing. Marlene proposes a list of reliability evaluation criteria in her 5th paper, and such criteria is extremely important especially if non-standard test data from literature should be possible to incorporate in a risk assessment process.
- All the ideas around improvements of the SECIS system. For instance, regarding reliability of the different classifications. Marlene also pointed out that the value of the system has mainly been making data publicly available and increased transparency, and it has helped placing the discussions on pharmaceuticals in the environment on the agenda. However it has not really been an effective "risk reduction tool", since the system does not really allow for replacing one product with another one. Remember that it is just a classification scheme for pharmaceutical SUBSTANCES, not the PRODUCTS (where also other environmental aspects than the environmental risk and hazard of the active pharmaceutical ingridient is of importance).
The latter issue will be possible to act upon through the project National Pharmaceutical Strategy Issue 7.2:
“Encourage voluntary control of emissions from pharmaceutical manufacturing: Introduction of a voluntary environmental labeling/assessment of pharmaceutical products”.
The assessment model that is being under development in this initiative will allow for differentiation on a PRODUCT level.
Congratulations Marlene (or Dr Ågerstrand which is now perhaps more appropriate) to a job well done!