European drug approval system flawed, says report


The EMA’s approval system of comparing new drugs with placebos instead of against existing alternatives is flawed, according to a new report.

Written by the London School of Economics (LSE), the report argues that pharmaceutical companies should prove how their drugs differ with comparators to gain European approval, to guarantee that only the best drugs are funded.

The document suggests this will ease healthcare resources around the world, ensuring that only the most beneficial and safest drugs reach patients.

Researchers from the LSE said: “Comparative efficacy evidence should have a formal role in drug licensing decisions.”

They said that open dialogue between regulators, drugmakers and government agencies would “achieve better congruence between licensing and reimbursement requirements”.

As it currently stands, the EMA only requires significant comparison against a placebo rather than an existing therapy.

The researchers argued that the current method does not allow healthcare professionals to determine the health values of the new drug, resulting in “the widespread use of potentially less efficacious and unsafe drugs”, they warn.

“With this success comes an equally important additional need – to develop a systematic approach to evaluate the risks and benefits of these new therapies in the context of existing alternatives.”