EMA staffers see excessive risk aversion in medicines regulation as a problem

Excessive risk aversion in regulatory decision-making on medicines is not in the best interest of patients and public health, according to an article published today (November 15) in Nature Reviews Drug Discovery by members of the European Medicines Agency staff, including its executive director and senior medical officer, chairs and members of EMA scientific committees, and representatives of national authorities.

"The negative consequences of regulatory tolerance in allowing drugs onto the market that turn out to be unsafe are obvious, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent," highlight the authors.

In their article, titled The risks of risk aversion un drug regulation, the authors argue that risk aversion could lead to denying a marketing authorization to a medicine, withdrawing it from the market or restricting its use when it would in fact have caused more good than harm.