PiE in the Sky?

After seven years’ evaluation, the EMEA last month published guidelines on pharmaceuticals in the environment. As of December 2006, a ‘robust’ environmental risk assessment has to be submitted with all new marketing authorisation applications. Why did this guidance take so long to develop? And what’s the long-term impact for pharma? For some time, most EU companies have been required to substantiate product safety (human and environmental) by in-depth risk assessment. So why is pharma only being called on now to join the party? Pharma is one of the best industries in the world at evaluating the risks of their products to man, but how do their green credentials line up against other industries when assessing risk to the environment?

SOCIETY AND SCIENTIFIC COMPROMISE

While society wishes for increased eco-vigilance, it also wants to reduce excessive use of animal testing. Creation of this EMA policy did not stem from knowledgeable risk assessments, rather from the lack of it. The question is this: ‘can industry and the scientific community fill the data vacuum that society has been lead to believe is missing?’ These new policies not only place increasing responsibility on manufacturers to demonstrate eco-safety, but also exert additional demands on scientific knowledge to sustain plausible regulatory judgements.