“Given what we know about the current regulatory landscape, we can say it is much easier to market living organisms as medical drugs,” said Pharmabiotics Research Institute (PRI) coordinator Joseph Simmons, who emphasised that for his group 'living organisms' did not necesarily equate to probiotics, which is for the moment at least, a non-authorised marketing term in the EU's 28 member states.
“One reason for these regulatory challenges [with foods and supplements] is that it’s much more difficult to prove prevention in a healthy patient than it is to demonstrate a mechanism of action in a sick patient.”
The population problem
Since the European Food Safety Authority (EFSA) began issuing opinions on health claim submissions under the NHCR in 2008, it has become clear that data based on healthy populations holds more weight than medical-style research based on diseased populations, even if the agency does not rule out them out completely.
Professor Ambroise Martin, head of EFSA’s Panel on Dietetic Products Nutrition and Allergies (NDA), spoke of the position at the International Probiotics Association (IPA) bi-annual meeting in Athens in May.
He told attendees: “Take antibiotic associated diarrhea – no problem. We can assess that. The population does not have to be healthy. We have accepted IBS (Irritable Bowel Syndrome). We have no problem to be at the borderline. Sometimes it is very subtle.”
“I hope there will be a positive opinion.”
The fact that has not happened yet, along with the already established presence of probiotics in the medical field with Russia and former Soviet Union states being prime examples of markets where probiotic drugs are routinely prescribed by medical professionals for paediatric, gut, immune and other conditions, is fuelling further interest in probiotics as medicines.
PRI board member and president of the European Scientific League for Probiotics (ESLP) Jean-Pol Warzée added: “A key part of the PRI vision is to get specific strains recognised for medicalised applications.”
Regulatory road blocks
Simmons said PRI members were drawn from both the pharmaceuticals and food and supplements sectors but the European Medicines Agency (EMA) was becoming the more attractive option.
“For example, up to now, some living microorganisms have been registered as ‘medical devices’ in different EU states,” said PRI executive scientist Magali Cordaillat-Simmons, speaking of a sub-route within EU medicines law that has become increasingly popular – for the moment at least.
“But from 2017, under the new EU Medical Devices Directive, it will no longer be possible to register these products that way.”
The PRI has supported its members in compiling pharmabiotic 'scientific opinion requests' that go to the EMA.
PRI is an EU, French and regionally-backed ‘excellence cluster’, that in part acts as a point of collaboration between academics and industry players, both large and small.
PRI members include Lallemand, Sanofi, Bristol-Meyers Squibb, Merck, DuPont-Danisco, INRA, IPRAD, Lesaffre and Protexin.
A pharmabiotics-themed event will take place in place in Paris at the end of October.