European risk assessment

In this column in May of this year, I discussed the question of pharmaceuticals in the environment and signalled the impending publication of the European Commission's draft proposals for the Environmental Risk Assessment of medicinal products.

These were discussed at the July meeting of the Committee on Proprietary Medicinal Products (CPMP) and were formally published for a six month consultation period on 30 July.

ABPI welcomes the publication of this draft, as the industry has been anxious for some time to receive more specific guidance as to what was expected in fulfilling its environmental impact assessment obligations under the medicines legislation.

The approach taken by CPMP is a tiered one, starting with a basic estimation of environmental exposure. If a certain threshold of potential exposure (a predicted environmental concentration (PEC) in surface water of 0.01µg/l using the formula set out in the draft) is met then this triggers a requirement for initial environmental testing. If this testing indicates potential environmental risk then further tiers of testing are required.

The draft indicates that certain compounds, such as oestrogens, will need to be tested whether or not they exceed the PEC threshold.

It is very early in the consultation process and the full text of the draft needs to be considered thoroughly. The industry, through its local trade associations and EFPIA, will be commenting on the draft guidance in due course and the outcome of these deliberations will be discussed in later issues of Manufacturing Chemist.