ROBERTO SUÁREZ
Regulatory Affairs Associate, Pen & Tec Consulting

Abstract

Psychobiotics are a new type of probiotics conferring mental health benefits to the host. However, scientists have not yet shed light on their mode of action and their impact on cognitive behaviour. The current knowledge is scarce and limited, but the main regulatory pathways for their registration in the European Union will be explored in this article, which presents a hypothetical legal scenario and highlights the principle obstacles psychobiotics will have to overcome. Overall, the lack of reliable behavioural models in humans and animals will pose the greatest challenge though more research will be also needed to establish and define their mechanism of action. Finally, a change in the European legal framework will also be indispensable for achieving the recognition of psychobiotics.

WHAT ARE PSYCHOBIOTICS?

Despite the word probiotic being strongly associated with beneficial effects in the gut, the scientific community is still investigating if the changes in the intestinal microbial population can affect other physiological processes. Over the past decades, the scientific community has been exploring the role of probiotics and their effect in psychiatric illness and other diseases with an important neurological factor, such as Crohn’s disease. It has been hypothesized that different gut flora bacteria can produce neuromodulating substances that might be beneficial for the nervous system. The pillars of this idea mainly lie in the gut-brain axis, a two-way communication between the gastrointestinal tract and the central nervous system where both systems interact and operate modulating each other. In 2013, Dinan et al. baptised this new class of probiotics capable of having an effect on the nervous system as “psychobiotics”.

COULD PSYCHOBIOTICS MAKE THEIR WAY TO MARKET? A LEGAL PERSPECTIVE

Based on the effects commonly attributed to psychobiotics, these neuromodulators could be marketed under ...