EU Drugs Harmonization's "Threat To Safety"

National safety standards for medicines in Europe are being threatenedby the drive for harmonization throughout the European Union, according to a new report published last month by two UK academic researchers.

In their report, The Interaction Between European Drug Regulation and Toxicological Science, John Abraham of Sussex University and Graham Lewis of Reading University claim that EU member states are competing for funding from the pharmaceutical industry on the basis of "turnaround speed" of applications for drug approvals. Moreover, the whole process lacks proper public accountability, the authors say.

The Europeanization of medicines control is occurring at a fast rate, according to Drs Abraham and Lewis. Under the current system, national regulatory authorities within the EU are competing with each other for regulatory work provided by fees from the pharmaceutical industry. This type of competition puts pressure on the national authorities to sell themselves as the fastest at reviewing and approving drugs, they say. Moreover, part of the process of regulatory assessment involves peer review among member states, and there is evidence of concern among regulators that the time pressures are undermining such peer review.