Environmental risks

It is a year since this column reviewed the current status of the debate on pharmaceuticals in the environment. In that time there has a good deal of activity in this area.

The long awaited draft guidelines from the Committee on Proprietary Medicinal Products (CPMP) on environmental risk assessment of new medicines eventually emerged in the summer of last year with a consultation period through to the end of January this year.

The draft guidelines are more comprehensive than previous drafts and are based on a two tier system. First there is a preliminary screening procedure to establish a crude predicted environmental concentration (PEC) in surface water. If this is equal to or greater than 0.01µg/litre in surface water then the applicant has to move on to a further tier of more intensive testing and assessment. Even where the PEC is less than 0.01µg/litre, there may be other considerations that suggest that the compound needs to be subject to further testing.

While industry welcomed the publication of the draft and was supportive of the general approach, there are concerns at some of the assumptions made in the derivation of the initial PEC. It will be interesting to see the degree to which industry concerns are reflected in reviewing the draft.

More locally in the UK, the Environment Agency, as part of its chemicals strategy, issued in October of last year a position statement on human pharmaceuticals in the environment in which it called on the pharmaceutical industry to work with it to review the topic more fully.

ABPI is now in discussion with the Agency to see how the proposals in the position paper can best be tackled.

This column will report back on developments on the above topics as they emerge.