Ten years’ experience with the environmental risk assessment of human medicinal products: What do we know now? and What are the future priorities for science-based policy?
Symposium sponsored by SETAC Pharmaceuticals Interest Group
Sunday 7th May 2017, 13:00 – 17:00, Meeting Studio 211 & 212
- Gerd Maack, UBA, Germany
- Thomas Backhaus, University of Gothenburg, Sweden
- Jason Snape, AstraZeneca, UK
- Mike Williams, CSIRO, Australia
The European Medicines Agency (EMA) guidance for the Environmental Risk Assessment (ERA) of human medicinal products  has been in place now for over 10 years. The introduction of this guidance marked a step change in the ERA requirements for human medicinal products, with a shift from short-term (acute) to long-term (chronic) environmental effects assessments, tailored ERAs for active pharmaceuticals ingredients (APIs) with suspected or known reproductive effects, and hazard-based assessments to identify APIs that are persistent, bioaccumulate and toxic (PBT).
In 2016, EMA launched an ERA concept paper  consultation against some targeted issues prior to updating the current ERA guidance for human medicinal products in 2017. For the revision of the guideline, the following aspects were addressed in the concept paper: (i) review of the tiered approach strategy and triggers for further assessment and additional studies, (ii) review of the groups of medicinal products for which data are not currently required due to the nature of their constituents and clarification of the scientific conditions for such approaches, (iii) review of possibilities for better utilisation of data in the public domain to make a scientifically sound assessment of the environmental risk, with a special interest to avoid unnecessary repetition of animal studies (e.g. fish), (iv) review of whether the approaches for substances with specific properties (e.g. PBT substances, endocrine disruptors, mixtures, substances highly toxic to specific taxonomic groups) are still adequate, (v) review of the applicability of the current test strategies to pharmaceuticals, considering their known pharmacodynamic and pharmacokinetic properties, (vi) update of test systems recommended in the current guideline based on new scientific information and if possible, their validity for specific types of medicinal products, (vii) consideration for recommendations of additional test systems/assays including areas not, or poorly, addressed in the present guideline, (viii) review of possible options for risk mitigation measures, including discussion on how to monitor the potential impact of pharmaceuticals in the environment.
This symposium will provide an evidence-based scientific perspective on the current EMA ERA guidance from academic, industrial and regulatory stakeholder perspective. The strengths and weaknesses of the ERA guideline will be identified together with science-based recommendations on how to improve the rigor and relevance of future ERA guidance for human medicinal products. The symposium will conclude with an open panel discussion to identify some of the key uncertainties and challenges that remain to be addressed to improve our knowledge and understanding of the environmental risks that human medicinal products pose.