November 9, 2011 by David Taylor

Interest in this subject has been given a boost by the appearance of a new EU Directive and associated regulation revising the law on pharmacovigilance. Recital 3 in the new regulation states:

“The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem. Member States should consider measures to monitor and evaluate the risk of environmental effects of such medicinal products for human use, including those which may have an impact on public health. The Commission should, based, inter alia, on data received from the Agency, the European Environment Agency, and Member States, produce a report on the scale of the problem, along with an assessment on whether amendments to Union legislation on medicinal products for human use or other relevant Union legis­lation are required.”

DG Sanco is currently seeking a contractor to help them to produce this report, but there is now a general view that some ecopharmacovigilance measures are likely to result. These issues were discussed at a recent meeting on the subject held in London at the Royal Society of Medicine. I co-chaired one of the sessions whilst my colleague John Fawell made a presentation on the recently published WHO Technical Report on the presence of Pharmaceuticals in Drinking Water. A review of the meeting has been already been published.

There is a clear view emerging from the industry that ecopharmacovigilance needs to be seen as a very specific activity not to be confused with the host of other issues that are encompassed by the term Sustainable Pharmacy. This latter term includes issues such as green process chemistry, water and energy conservation, minimisation of packaging etc. Gisela Holm from AstraZeneca was very clear that Ecopharmacovigilance was a process that started at the launch of the compound and she proposed a definition very closely related to the WHO Definition of pharmacovigilence:

The science and activities associated with the detection, evaluation, understanding and prevention of adverse effects of pharmaceuticals in the environment”

How to undertake effective ecopharmacovigilance is a however a problem yet to find a solution.