A former colleague of mine, Dr Vyv Coombe and I have just published a chapter on the environmental and regulatory aspects of Green Chemistry and the Pharmaceutical Industry in a new book edited by Peter J Dunn, Andrew S Wells and Michael T Williams published by Wiley-VCH. A preview of the book is available on the publisher’s website.

The chapter provides a short summary of our knowledge of the interaction of pharmaceutical residues in the aquatic environment and how this has developed over the last decade, whilst the second part of the chapter deals with environmental regulatory background.

Green Chemistry in the Pharmacetical Industry

The industry is very heavily regulated by national medicines agencies such as the US Food & Drug Administration (FDA), with research, clinical trials and manufacturing of pharmaceuticals being covered by rigorous compliance regulations with the objective of ensuring consistent high quality. These Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations are strictly enforced and subject to random inspection.

No new medicinal product can be introduced onto the market until the appropriate medicines regulator, such as the European Medicines Evaluation Agency (EMEA) or the FDA has approved its safety, effectiveness and quality. Until recently the requirements for the evaluation of the environmental impact of active pharmaceutical ingredients were rudimentary and only required in the USA and Europe. However, the emergence of the Pharmaceuticals in the Environment issue has fundamentally changed this. In 2007, the European Medicines Evaluation Agency (EMEA) released a guidance document setting out a comprehensive methodology for the evaluation of the environmental risk assessment of medicines for human use.

Many people within the pharmaceutical industry seem to think that the only regulations which apply to pharmaceuticals are those derived from the medicines regulators such as the FDA and EMEA. However, this is not the case and increasingly pharmaceuticals are coming to the attention of environmental regulators.

In the European Union, the industry is subject to a range of directives such as those on Integrated Pollution Prevention & Control (IPPC), the Packaging Directive, the Water Framework Directive (WFD) as well as aspects of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals).

In terms of regulation, there is probably little need for additional primary regulation in either Europe or the USA. However, it is likely that the existing legal instruments such as the Clean Drinking Water Act in the USA and the Water Framework Directive in the EU will be applied more explicitly to pharmaceuticals in order to control discharges to the aquatic environment. The environmental risk assessment of active ingredients is likely to become more sophisticated and uniform between Europe, Japan and North America. However, a referral to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is probably premature, in view of the rapid scientific developments in this area. Nevertheless harmonisation by ICH is possible within the next 10 years.