The European Medicines Agency (EMA) is out with a new concept paper calling for a new guideline on an emerging aspect of the assessment process for some products: How does the use of the product affect the environment?

Background

That pharmaceutical products have the potential to contaminate groundwater is not a particularly new, either in concept or practice.

Byproducts of the manufacturing process, for example, can often find their way into the environment, causing damage. In one prominent case, pharmaceutical manufacturer Merck was found by a court to have polluted the environment around a Beachwood, CA manufacturing facility, which thankfully avoided contaminating the public water supply.

Other studies, however, have looked at the concentration of pharmaceutical products in the water supply, which can pass into it through bodily secretions or improper disposal. One US geological survey of California's water supply found detectible concentrations of acetaminophen, sulfamethoxazole, trimethoprim, codeine, carbamazepine, and thiabendazole, a veterinary antiparasitic drug. At issue: Could these products be harmful to humans and the environment?

Call for a New Guideline

EMA's new concept paper notes that companies are already required to conduct environmental impact assessments for veterinary products if the product is expected to enter the groundwater beyond certain threshold levels established in the Veterinary International Conference on Harmonization's (VICH) GL6 and GL38 guidelines.

Those guidelines now outline a two-step process for conducting an environmental risk assessment (ERA) in which companies are expected to identify all veterinary pharmaceutical compounds that would be present in the water supply at levels beyond 0.1 µg/l. If compounds are detected at levels beyond that threshold, companies would need to conduct a risk assessment in order to assuage regulators.

The problem, the agency writes, is that those guidelines don't explain how such a risk assessment should be performed. And that's no small issue for companies, which are far more used to conducting assessments of safety and efficacy in controlled clinical trials than they are conducting environmental impact assessments.

"The current absence of guidance on how such a risk assessment should be performed represents a difficulty for both applicants and assessors," EMA explained.

Environmental Assessment: Both Human and Nature

As a result, EMA says it wants to generate a new guideline to "provide further technical support to the implementation of the VICH guidelines GL6 and GL38 on the ERA of veterinary medical products (VMPs)."

That guideline, it said, should include two types of assessments, the first very familiar to companies and the second largely unfamiliar. The first assessment should be done in relation to human health, and whether the drug could present risks if present at certain concentrations. The second part of the proposed assessment process, however, would be done on the environment itself.

"The methodology should consider … the risk to the environment," EMA wrote.

A timeline for the document would see a first draft of the document released in July 2014, with final adoption by September 2015. EMA said it will be accepting comments through June 2013. Comments may be submitted here.